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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ | QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended September 30, 2024
or
☐ | TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from _________ to _____________
Commission
file number: 001-11460
Eterna
Therapeutics Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
31-1103425 |
(State
of incorporation) |
|
(I.R.S.
Employer Identification No.) |
1035
Cambridge Street, Suite 18A
Cambridge,
Massachusetts |
|
02141 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(212)
582-1199
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
symbol |
|
Name
of each exchange on which registered |
Common
stock, $0.005 par value per share |
|
ERNA |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every interactive data file required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
Emerging
growth company |
☐ |
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 8, 2024, the registrant had outstanding 51,374,713 shares of common stock, $0.005 par value per share.
TABLE
OF CONTENTS
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains “forward-looking statements” as that term is defined under the Private Securities
Litigation Reform Act of 1995 (“PSLRA”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),
and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include
statements related to future events, results, performance, prospects and opportunities, including statements related to our strategic
plans, capital needs, and our financial position. Forward-looking statements are based on information currently available to us, on our
current expectations, estimates, forecasts, and projections about the industries in which we operate and on the beliefs and assumptions
of management. Forward looking statements often contain words such as “expects,” “anticipates,” “could,”
“targets,” “projects,” “intends,” “plans,” “believes,” “seeks,”
“estimates,” “may,” “will,” “would,” and similar expressions. In addition, any statements
that refer to projections of our future financial performance, our anticipated growth and trends in our business, and other characterizations
of future events or circumstances, are forward-looking statements. Forward-looking statements by their nature address matters that are,
to different degrees, subject to risks and uncertainties that could cause actual results to differ materially and adversely from those
expressed in any forward-looking statements. For us, particular factors that might cause or contribute to such differences include those
risks and uncertainties described in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended
December 31, 2023 filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2024, in Part II, Item 1A “Risk
Factors” of this Quarterly Report on Form 10-Q, and in other documents we file from time to time with the SEC.
Readers
are urged not to place undue reliance on the forward-looking statements in this Quarterly Report on Form 10-Q, which speak only as of
the date of this Quarterly Report on Form 10-Q. We are including this cautionary note to make applicable, and take advantage of, the
safe harbor provisions of the PSLRA. Except as required by law, we do not undertake, and expressly disclaim any obligation, to disseminate,
after the date hereof, any updates or revisions to any such forward-looking statements to reflect any change in expectations or events,
conditions or circumstances on which any such statements are based.
We
believe that the expectations reflected in forward-looking statements in this Quarterly Report on Form 10-Q are based upon reasonable
assumptions at the time made. However, given the risks and uncertainties, you should not rely on any forward-looking statements as a
prediction of actual results, developments or other outcomes. You should read these forward-looking statements with the understanding
that we may be unable to achieve projected results, developments or other outcomes and that actual results, developments or other outcomes
may be materially different from what we expect.
Unless
stated otherwise or the context otherwise requires, all references in this Quarterly Report on Form 10-Q to “Eterna” refer
to Eterna Therapeutics Inc., references to “Eterna LLC” refer to Eterna Therapeutics LLC, a wholly owned subsidiary of Eterna,
and references to the “Company,” “we,” “us” or “our” refer to Eterna and its subsidiaries,
including Eterna LLC, Novellus, Inc. and Novellus Therapeutics Limited.
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
ETERNA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value amounts)
(unaudited)
| |
September 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 4,264 | | |
$ | 7,575 | |
Other receivables | |
| 187 | | |
| 425 | |
Prepaid expenses and other current assets | |
| 279 | | |
| 1,599 | |
Total current assets | |
| 4,730 | | |
| 9,599 | |
Restricted cash | |
| - | | |
| 4,095 | |
Property and equipment, net | |
| 105 | | |
| 493 | |
Right-of-use assets - operating leases | |
| 719 | | |
| 32,781 | |
Goodwill | |
| 2,044 | | |
| 2,044 | |
Other assets | |
| 120 | | |
| 120 | |
Total assets | |
$ | 7,718 | | |
$ | 49,132 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,193 | | |
$ | 1,067 | |
Accrued expenses | |
| 1,166 | | |
| 1,893 | |
Income taxes payable | |
| 18 | | |
| 2 | |
Bridge notes, net of debt discount | |
| 776 | | |
| - | |
Bridge notes derivative liability | |
| 4,926 | | |
| - | |
Operating lease liabilities, current | |
| 201 | | |
| 2,216 | |
Due to related party, current | |
| 559 | | |
| 1,205 | |
Deferred revenue, current | |
| - | | |
| 190 | |
Other current liabilities | |
| 113 | | |
| - | |
Total current liabilities | |
| 9,952 | | |
| 6,573 | |
Convertible notes, net | |
| 32,037 | | |
| 6,773 | |
Warrant liabilities | |
| 10,463 | | |
| 116 | |
Operating lease liabilities, non-current | |
| 534 | | |
| 32,854 | |
Deferred revenue, non-current | |
| - | | |
| 392 | |
Contingent consideration liability | |
| 41 | | |
| 107 | |
Other liabilities | |
| 84 | | |
| 84 | |
Total liabilities | |
| 53,111 | | |
| 46,899 | |
| |
| | | |
| | |
Stockholders’ (deficit) equity: | |
| | | |
| | |
Preferred stock, $0.005 par value, 1,000 shares authorized, 156 designated and outstanding of Series A
convertible preferred stock at September 30, 2024 and December 31, 2023, $156 liquidation preference | |
| 1 | | |
| 1 | |
Common stock, $0.005 par value, 100,000 shares authorized at September 30, 2024 and December 31, 2023; 5,411 and 5,410 issued
and outstanding at September 30, 2024 and December 31, 2023, respectively | |
| 27 | | |
| 27 | |
Additional paid-in capital | |
| 180,348 | | |
| 189,186 | |
Accumulated deficit | |
| (225,769 | ) | |
| (186,981 | ) |
Total stockholders’ (deficit) equity | |
| (45,393 | ) | |
| 2,233 | |
| |
| | | |
| | |
Total liabilities and stockholders’ (deficit) equity | |
$ | 7,718 | | |
$ | 49,132 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ETERNA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts)
(unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue | |
$ | 487 | | |
$ | 51 | | |
$ | 581 | | |
$ | 51 | |
Cost of revenues | |
| (60 | ) | |
| 120 | | |
| 96 | | |
| 170 | |
Gross income (loss) | |
| 547 | | |
| (69 | ) | |
| 485 | | |
| (119 | ) |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 1,001 | | |
| 1,387 | | |
| 3,446 | | |
| 4,560 | |
General and administrative | |
| 3,381 | | |
| 4,049 | | |
| 11,592 | | |
| 10,231 | |
Gain on lease termination | |
| (1,576 | ) | |
| - | | |
| (1,576 | ) | |
| - | |
Acquisition of Exacis in-process research and development | |
| - | | |
| - | | |
| - | | |
| 460 | |
Total operating expenses | |
| 2,806 | | |
| 5,436 | | |
| 13,462 | | |
| 15,251 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,259 | ) | |
| (5,505 | ) | |
| (12,977 | ) | |
| (15,370 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other expense, net: | |
| | | |
| | | |
| | | |
| | |
Loss on extinguishment of debt | |
| (22,440 | ) | |
| - | | |
| (22,440 | ) | |
| - | |
Fair value adjustments to bridge notes derivative liability | |
| (1,038 | ) | |
| - | | |
| (1,038 | ) | |
| - | |
Change in fair value of warrant liabilities | |
| 831 | | |
| 20 | | |
| 897 | | |
| 166 | |
Change in fair value of contingent consideration | |
| - | | |
| - | | |
| 66 | | |
| 118 | |
Loss on non-controlling investment | |
| - | | |
| - | | |
| - | | |
| (59 | ) |
Interest expense, net | |
| (1,686 | ) | |
| (113 | ) | |
| (3,269 | ) | |
| (88 | ) |
Other expense, net | |
| - | | |
| (1 | ) | |
| - | | |
| (281 | ) |
Total other expense, net | |
| (24,333 | ) | |
| (94 | ) | |
| (25,784 | ) | |
| (144 | ) |
| |
| | | |
| | | |
| | | |
| | |
(Provision) benefit for income taxes | |
| (12 | ) | |
| 8 | | |
| (19 | ) | |
| (1 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (26,604 | ) | |
| (5,591 | ) | |
| (38,780 | ) | |
| (15,515 | ) |
| |
| | | |
| | | |
| | | |
| | |
Series A preferred stock dividend | |
| - | | |
| - | | |
| (8 | ) | |
| (8 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss attributable to common stockholders | |
$ | (26,604 | ) | |
$ | (5,591 | ) | |
$ | (38,788 | ) | |
$ | (15,523 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share - basic and diluted | |
$ | (4.92 | ) | |
$ | (1.03 | ) | |
$ | (7.17 | ) | |
$ | (2.94 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average shares outstanding - basic and diluted | |
| 5,410 | | |
| 5,410 | | |
| 5,410 | | |
| 5,281 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ETERNA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY
For
the three and nine months ended September 30, 2024 and 2023 (unaudited)
(in
thousands)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
Series A Preferred Stock | | |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balances at July 1, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,411 | | |
$ | 27 | | |
$ | 190,611 | | |
$ | (199,165 | ) | |
$ | (8,526 | ) |
Fair value of forward sale contract pursuant to common stock offering | |
| - | | |
| - | | |
| - | | |
| - | | |
| 576 | | |
| - | | |
| 576 | |
Reclassification of warrants to liability | |
| - | | |
| - | | |
| - | | |
| - | | |
| (11,244 | ) | |
| - | | |
| (11,244 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 405 | | |
| - | | |
| 405 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (26,604 | ) | |
| (26,604 | ) |
Balances at September 30, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,411 | | |
$ | 27 | | |
$ | 180,348 | | |
$ | (225,769 | ) | |
$ | (45,393 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at January 1, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 189,186 | | |
$ | (186,981 | ) | |
$ | 2,233 | |
Fair value of forward sale contract pursuant to common stock offering | |
| - | | |
| - | | |
| - | | |
| - | | |
| 576 | | |
| - | | |
| 576 | |
Reclassification of warrants to liability | |
| - | | |
| - | | |
| - | | |
| - | | |
| (11,244 | ) | |
| - | | |
| (11,244 | ) |
Issuance of note warrants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 720 | | |
| - | | |
| 720 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,110 | | |
| - | | |
| 1,110 | |
Issuance of common stock from vested restricted units | |
| - | | |
| - | | |
| 1 | | |
| - | | |
| - | | |
| - | | |
| - | |
Cash dividends to Series A preferred stockholders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8 | ) | |
| (8 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (38,780 | ) | |
| (38,780 | ) |
Balances at September 30, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,411 | | |
$ | 27 | | |
$ | 180,348 | | |
$ | (225,769 | ) | |
$ | (45,393 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at July 1, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 179,067 | | |
$ | (175,229 | ) | |
$ | 3,866 | |
Issuance of warrants in connection with convertible notes financing | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,113 | | |
| - | | |
| 5,113 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 174 | | |
| - | | |
| 174 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,591 | ) | |
| (5,591 | ) |
Balances at September 30, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 184,354 | | |
$ | (180,820 | ) | |
$ | 3,562 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at January 1, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,127 | | |
$ | 26 | | |
$ | 177,377 | | |
$ | (165,297 | ) | |
$ | 12,107 | |
Issuance of common stock in connection with Exacis asset acquisition | |
| - | | |
| - | | |
| 69 | | |
| - | | |
| 208 | | |
| - | | |
| 208 | |
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC,
net | |
| - | | |
| - | | |
| 214 | | |
| 1 | | |
| 579 | | |
| - | | |
| 580 | |
Issuance of warrants in connection with convertible notes financing | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,113 | | |
| - | | |
| 5,113 | |
Cash dividends to Series A preferred stockholders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8 | ) | |
| (8 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,077 | | |
| - | | |
| 1,077 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (15,515 | ) | |
| (15,515 | ) |
Balances at September 30, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 184,354 | | |
$ | (180,820 | ) | |
$ | 3,562 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ETERNA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(unaudited)
| |
2024 | | |
2023 | |
| |
For the nine months ended September 30, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (38,780 | ) | |
$ | (15,515 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 120 | | |
| 62 | |
Stock-based compensation | |
| 1,110 | | |
| 1,077 | |
Amortization of right-of-use asset | |
| 1,450 | | |
| 580 | |
Gain on lease termination | |
| (1,576 | ) | |
| - | |
Accrued interest expense | |
| 441 | | |
| 113 | |
Paid-in-kind interest expense | |
| 829 | | |
| - | |
Amortization of debt discount and debt issuance costs | |
| 2,148 | | |
| 52 | |
Loss on extinguishment of debt | |
| 22,440 | | |
| - | |
Fair value adjustments to bridge notes derivative liability | |
| 1,038 | | |
| | |
Change in fair value of warrant liabilities | |
| (897 | ) | |
| (166 | ) |
Change in fair value of contingent consideration liability | |
| (66 | ) | |
| (118 | ) |
Commitment shares issued to Lincoln Park Capital, LLC | |
| - | | |
| 249 | |
Loss on shares sold to Lincoln Park Capital, LLC | |
| - | | |
| 11 | |
Non-cash component of acquisition of Exacis in-process research and development | |
| - | | |
| 433 | |
Gain on disposal of fixed assets | |
| - | | |
| 1 | |
Loss on non-controlling investment | |
| - | | |
| 59 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Other receivables | |
| 238 | | |
| (825 | ) |
Prepaid expenses and other current assets | |
| 1,225 | | |
| 340 | |
Other non-current assets | |
| 1 | | |
| (2,911 | ) |
Accounts payable and accrued expenses | |
| 758 | | |
| 1,099 | |
Operating lease liability | |
| (1,656 | ) | |
| 795 | |
Due to related party | |
| (646 | ) | |
| (1,313 | ) |
Deferred revenue | |
| (582 | ) | |
| 599 | |
Other liabilities | |
| 113 | | |
| (369 | ) |
Net cash used in operating activities | |
| (12,291 | ) | |
| (15,747 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchase of property and equipment | |
| (369 | ) | |
| - | |
Proceeds received from the sale of fixed assets | |
| 4 | | |
| - | |
Net cash used in investing activities | |
| (365 | ) | |
| - | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds received from convertible note financings | |
| 1,405 | | |
| 8,715 | |
Fees paid related to convertible note financings | |
| (34 | ) | |
| (175 | ) |
Proceeds received from bridge notes financings | |
| 3,887 | | |
| - | |
Proceeds from sale of common stock pursuant to stock purchase agreement with Lincoln Park Capital Fund, LLC | |
| - | | |
| 320 | |
Dividends paid to Series A preferred stockholders | |
| (8 | ) | |
| (8 | ) |
Net cash provided by financing activities | |
| 5,250 | | |
| 8,852 | |
Net decrease in cash and cash equivalents | |
| (7,406 | ) | |
| (6,895 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 11,670 | | |
| 15,541 | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 4,264 | | |
$ | 8,646 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Cash paid during the period for: | |
| | | |
| | |
Interest | |
$ | 46 | | |
$ | 13 | |
Income taxes | |
$ | 2 | | |
$ | 4 | |
| |
| | | |
| | |
Supplemental disclosure of non-cash investing and financing activities: | |
| | | |
| | |
Note warrants issued | |
$ | 755 | | |
$ | - | |
Unpaid fees incurred in connection with the December 2023 financing | |
$ | 32 | | |
$ | - | |
Paid in-kind interest added to convertible notes principal | |
$ | 1,006 | | |
$ | - | |
Adjustment to lease liability and ROU asset due to remeasurement | |
$ | 4,245 | | |
$ | - | |
Reclassification of warrants to liability | |
$ | 11,244 | | |
$ | - | |
Warrants issued in connection with July 2023 Financing | |
$ | - | | |
$ | 5,234 | |
Unpaid fees incurred in connection with the July 2023 Financing | |
$ | - | | |
$ | 27 | |
Initial measurement of ROU assets | |
$ | - | | |
$ | 34,410 | |
Initial measurement of lease liability | |
$ | - | | |
$ | 34,170 | |
Contingent consideration for Exacis asset acquisition | |
$ | - | | |
$ | 225 | |
Issuance of common stock for Exacis asset acquisition | |
$ | - | | |
$ | 208 | |
| |
| | | |
| | |
Reconciliation of cash, cash equivalents and restricted cash at end of period: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 4,264 | | |
$ | 4,551 | |
Restricted cash | |
| - | | |
| 4,095 | |
Total cash, cash equivalents and restricted cash at end of period | |
$ | 4,264 | | |
$ | 8,646 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ETERNA
THERAPEUTICS INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1) | DESCRIPTION
OF BUSINESS AND BASIS OF PRESENTATION |
Description
of Business
Eterna
Therapeutics Inc. (the “Company”) is a preclinical-stage cell therapy company. Its vision is to improve the lives
of patients with difficult-to-treat diseases through innovative, effective, and safe, but accessible cellular therapies, and its mission
is to develop allogenic off-the-shelf cellular therapies, leveraging induced pluripotent stem cell (“iPSC”)-derived mesenchymal
stem cells (“iMSCs”) to target solid tumors. As used herein, the “Company” or “Eterna” refers collectively
to Eterna and its consolidated subsidiaries (Eterna Therapeutics LLC, Novellus, Inc. and Novellus Therapeutics Limited) unless otherwise
stated or the context otherwise requires .
Basis
of Presentation
The
accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial statements and with the instructions to Form 10-Q
and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete
financial statements. In the opinion of management, the unaudited financial statements include all the normal recurring adjustments that
are necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented.
These
condensed consolidated financial statements should be read together with the audited consolidated financial statements and notes thereto
contained in Eterna’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission
(the “SEC”) on March 14, 2024, as amended by the Form 10-K/A filed with the SEC on March 18, 2024 (as amended, the “2023
10-K”). The accompanying condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited financial
statements contained in the 2023 10-K but does not include all of the information and footnotes required by GAAP for complete financial
statements. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results
to be anticipated for the entire year ending December 31, 2024, or any other period.
Reclassifications
Certain
reclassifications have been made to the Company’s prior year amounts to conform to the current year presentation.
2) | LIQUIDITY
AND CAPITAL RESOURCES |
The Company
has incurred significant operating losses and has an accumulated deficit as a result of its efforts to develop product candidates
and providing general and administrative support for operations. As of September 30, 2024, the Company had an unrestricted cash
balance of approximately $4.3 million and an
accumulated deficit of approximately $225.8
million. For the three and nine months ended September 30, 2024, the Company incurred a net loss of $26.6
million and $38.8
million, respectively, and for the nine months ended September 30, 2024, the Company used cash of $12.3
million in operating activities.
In
October 2022, the Company entered into a sublease for approximately 45,500 square feet of office and laboratory space in Somerville,
Massachusetts. Pursuant to the sublease, the Company delivered to the sublessor a security deposit in the form of a letter of credit
in the amount of $4.1 million. The letter of credit was issued by the Company’s commercial bank, which required that the Company
cash collateralize the letter of credit by depositing $4.1 million in a restricted cash account with such bank.
On
August 5, 2024, the sublessor drew down on the letter of credit for the full $4.1 million to cover past due rent, plus penalties and
interest. On August 9, 2024, the Company and the sublessor entered into a sublease termination agreement, effective August 31, 2024.
See Note 8 for additional information regarding the sublease and sublease termination agreement..
In
April 2023, the Company entered into a standby equity purchase agreement (the “ELOC”) and a registration rights agreement
with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $10.0 million
of the Company’s common stock in an “equity line” financing arrangement. During the year ended December 31, 2023, the
Company issued and sold approximately 214,000 shares of common stock under the ELOC for gross proceeds of $0.3 million. No shares were sold under the ELOC during the three or nine months ended September 30, 2024.
In
July and December 2023, the Company received $16.5 million in aggregate gross proceeds from the issuance of convertible notes, and on
January 11, 2024 it received an additional $1.4 million in gross proceeds from the issuance of additional convertible notes. On September
24, 2024, the Company received $3.9 million in aggregate gross proceeds from the issuance of convertible notes, and on October 29, 2024,
the Company received $1.1 million in gross proceeds from the sale of shares of the Company’s common stock. See Note 5 and Note
17 for additional information regarding these financings.
In
connection with preparing the accompanying condensed consolidated financial statements as of and for the three and nine months ended
September 30, 2024, the Company’s management concluded that there is substantial doubt regarding the Company’s ability to
continue as a going concern because it does not expect to have sufficient cash or working capital resources to fund operations for the
twelve-month period subsequent to the issuance date of these condensed consolidated financial statements. The Company will need to raise
additional capital, which could be through the sales of shares of its common stock under the ELOC, public or private equity offerings,
debt financings, out-licensing the Company’s intellectual property, strategic partnerships or other means. Other than the ELOC,
the Company currently has no arrangements for capital, and no assurances can be given that it will be able to raise capital when needed,
on acceptable terms, or at all.
The
accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. The accompanying condensed consolidated financial statements
do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts
and classifications of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
On
April 26, 2023, the Company entered into an asset purchase agreement (the “Exacis Purchase Agreement”), with Dilos Bio (formerly
known as Exacis Biotherapeutics Inc. (“Exacis”)), the stockholders party thereto and, with respect to specified provisions
therein, Factor Limited. Pursuant to the Exacis Purchase Agreement, the Company acquired from Exacis substantially all of Exacis’
intellectual property assets (the “Exacis Assets”), including all of Exacis’ right, title and interest in and to an
exclusive license agreement between Exacis and Factor Limited (the “Purchased License”). The Company assumed none
of Exacis’ liabilities, other than liabilities under the Purchased License that accrue subsequent to the closing date. The transactions
contemplated by the Exacis Purchase Agreement (the “Exacis Acquisition”) closed on April 26, 2023.
In
consideration for the Exacis Assets, on the closing date of the transaction, the Company issued to Exacis approximately 69,000
shares of common stock, which shares were subject
to a 12-month
lockup that expired in April 2024. The shares were issued to Exacis at a price based on the Company having an assumed equity valuation
of $75.0
million, divided by the number of issued and
outstanding shares of common stock as of the close of business two trading days prior to the closing date. For accounting purposes, the
shares issued were valued at $3.00
per share, which was the closing price of the
Company’s common stock on the date of issuance. The Company additionally agreed to make certain contingent payments through April
23, 2026 related to achieving a market capitalization of $100 million and $200 million for a consecutive period of time (the “Market
Cap Contingent Consideration”), as well as contingent payments related to the Company receiving proceeds related to the Purchased
License through April 23, 2028.
The
Company accounted for the Exacis Acquisition as an asset acquisition because it determined that substantially all of the fair value of
the assets acquired was concentrated in the Purchased License. Assets acquired in an asset acquisition are recognized based on their
cost to the acquirer and generally allocated to the assets on a relative fair value basis. The Company’s cost for acquiring the
Exacis Assets includes the issuance of the Company’s common stock, direct acquisition-related costs and contingent consideration.
The table below shows the total fair value of the consideration paid for the Exacis Assets (in thousands). See Note 4 for more information
on the fair value measurement of the assets acquired.
SCHEDULE OF FAIR VALUE MEASUREMENT OF ASSETS ACQUIRED
| |
Fair Value of Consideration | |
Shares issued | |
$ | 208 | |
Contingent consideration | |
| 225 | |
Direct costs | |
| 27 | |
Total fair value | |
$ | 460 | |
The
Company allocated 100% of the fair value of the consideration to the Purchased License, which the Company determined is an in-process
research and development (“IPR&D”) asset. IPR&D assets acquired through an asset purchase that have no alternative
future uses and no separate economic values from their original intended purpose are expensed in the period the cost is incurred. As
a result, the Company expensed the fair value of the Purchased License during the three and nine months ended September 30, 2023.
On
September 24, 2024, in connection with entering into the Exclusive License and Collaboration Agreement (“the Factor L&C Agreement”)
with Factor Bioscience Limited (“Factor Limited”), the Purchase License was terminated. See Note 10 for more information
on the Factor L&C Agreement.
On
February 21, 2023, the Company and Lineage Cell Therapeutics, Inc. (“Lineage”) entered into an exclusive option and
license agreement (the “Lineage Agreement”), which provided Lineage with the option (the “Option Right”) to
obtain an exclusive sublicense of intellectual property from the Company and to request the Company to develop a customized cell
line (the intellectual property that would be sublicensed by Lineage is currently licensed by the Company from Factor Limited). The
Lineage Agreement was amended in August 2023 to provide for changes specifically related to the cell line customization activities
such as (i) payment terms, (ii) certain definitions, (iii) certain courses of action if the customized cell line selected by Lineage
is not successful and (iv) documentation requirements. Lineage paid the Company a $0.3
million non-refundable up-front payment (the “Option Fee”) for the Option Right and paid an initial payment of $0.4
million to commence the cell line customization activities, per the amended payment terms. If Lineage obtained the sublicense, the
Company would be entitled to receive additional license fees, including milestone payments and royalties.
On
September 24, 2024, the Company and Factor Bioscience (as defined in Note 10) entered into an agreement (the “Lineage Assignment
Agreement”) under which the Company assigned the Lineage Agreement to Factor Bioscience. The Company’s rights and obligations
under the agreement are now the responsibility of Factor Bioscience.
Payments
to the Company related to the Lineage Agreement will be subject to the Lineage Assignment Agreement, which provides for Factor Bioscience
paying the Company thirty percent (30%) of all amounts it actually receives from Lineage in the event that Lineage exercises its Option
Right. Upon receipt of payment for the customization activities set forth in the Lineage Agreement, Factor Bioscience will pay the Company
twenty percent (20%) of all amounts Factor Bioscience receives from Lineage.
The
Company recognizes revenue under ASC 606, Revenue from Contracts with Customers (“ASC 606”) when a customer obtains
control of promised services or goods in an amount that reflects the consideration to which the Company expects to receive in exchange
for those goods or services.
Pursuant
to ASC 606, the Company determined that the Option Right was an unexercised right held by Lineage under the Lineage Agreement at contract
inception, as the cell line customization activities and the sublicense were optional purchases at contract inception. These optional
purchases of goods and services would be treated as separate contracts if and when Lineage determines that it would make such purchases.
Therefore, 100% of the Option Fee was allocated to the Option Right. The Option Fee would remain in deferred revenue until such time
that Lineage entered into the sublicense or when the Option Right expired. However, as a result of the Lineage Assignment Agreement,
and there being no further obligations regarding the nonrefundable payment related to the Option Right, the Company recognized the $0.3
million Option Right payment in full as revenue during the three and nine months ended September 30, 2024.
The
Option Right and the cell line customization activities were accounted for as separate contracts, and the Company determined that the
amended terms discussed above represented a modification to the cell line customization contract. Because there were no goods or services
transferred to Lineage before entering into the amendment, and therefore, no previously recognized revenue, there was no catch-up adjustment
to revenue required at the time of the amendment.
Lineage
was to make payments to the Company for the cell line customization activities over the development period. The Company would only earn
the remaining full amount of the cell line customization fee if it made certain progress towards delivery of the customized cell line.
The Company determined that $0.4 million of consideration received could be recognized without the probability of being reversed, and
it placed a constraint on the remaining contractual customization fee. The $0.4 million was being recognized equally over the development
period. However, as a result of the Lineage Assignment Agreement, and there being no further obligations the Company must fulfill for
the customization activities, the Company accelerated the recognition of the remaining deferred revenue and recognized approximately
$0.2 million during the three and nine months ended September 30, 2024. The Company recognized approximately $0.1 million in revenue during
the three and nine months ended September 30, 2023 related to the customization activities.
The
Company recognized direct labor and supplies used in the customization activities as incurred, which are recorded as a cost of revenue.
As provided for in the A&R Factor License Agreement discussed in Note 10, the Company was obligated to pay Factor Limited 20% of
any amounts the Company received from a customer that was related to the licensed technology under the A&R Factor License Agreement,
which is also recorded as a cost of revenue. For the three and nine months ended September 30, 2023, the Company recognized $0.1 million
in license fees, which is recorded in cost of revenues, due to Factor Limited. There was no such license fee incurred during the three
or nine months ended September 30, 2024.
5) | CONVERTIBLE
NOTES FINANCINGS, BRIDGE FINANCING, EXCHANGE TRANSACTION AND EQUITY FINANCING |
On
July 14, 2023, the Company received $8.7 million from a private placement in which the Company issued $8.7 million in aggregate principal
amount of convertible notes (the “July 2023 Convertible Notes”) and warrants to purchase an aggregate of approximately 6.1
million shares of its common stock (the “July 2023 Warrants”). The Company recognized approximately $0.2 million in fees associated
with the transaction.
On
December 14, 2023, the Company entered into a purchase agreement with certain purchasers for the private placement of $9.2 million of
convertible notes (the “December 2023 Convertible Notes” and together with the July 2023 Convertible Notes, the “Convertible
Notes”) and warrants to purchase an aggregate of approximately 9.6 million shares of the Company’s common stock (the “December
2023 Warrants” and together with the July 2023 Warrants, the “Note Warrants”).
There
were two closings under the December 14, 2023 purchase agreement – one on December 15, 2023 and the second on January 11, 2024.
At the first closing, the Company received $7.8 million and issued $7.8 million of December 2023 Convertible Notes and December 2023
Warrants to purchase approximately 8.1 million shares of its common stock. At the second closing, the Company received $1.4 million and
issued $1.4 million of December 2023 Convertible Notes and December 2023 Warrants to purchase approximately 1.5 million shares its common
stock.
See
Note 13 for more information on the Note Warrants.
The
July 2023 Convertible Notes bear interest at 6% per year, and the December 2023 Convertible Notes bear interest at 12% per year, both
of which are payable quarterly in arrears. At the Company’s election, it may pay interest either in cash or in-kind by increasing
the outstanding principal amount of the Convertible Notes. The Convertible Notes mature on the five-year anniversary of the date of their
issuance, unless earlier converted or repurchased. The Company does not have the option to redeem any of the Convertible Notes prior
to maturity.
At
the option of the holders, the Convertible Notes may be converted from into shares of the Company’s
common stock at an initial conversion price of, with respect to the July 2023 Convertible Notes, $2.86 per share and, with respect to
the December 2023 Convertible Notes, $1.9194 per share, subject to customary adjustments for stock splits, stock dividends, recapitalization
and the like.
As
of September 30, 2024, none of the Convertible Notes were converted into shares of common stock.
The
Convertible Notes provide for customary events of default which include (subject in certain cases to customary grace and cure periods),
among others: nonpayment of principal or interest, breach of covenants or other agreements in the Convertible Notes; the occurrence of
a material adverse effect event (as defined in the related securities purchase agreement) and certain events of bankruptcy. Generally,
if an undisputed event of default occurs and is continuing under the Convertible Notes, the holder may require the Company to
redeem some or all of their Convertible Notes at a redemption price equal to 100% of the principal amount of the Convertible Notes being
redeemed, plus accrued and unpaid interest thereon. As of September 30, 2024, there were no events of default that occurred under any
of the Convertible Notes.
Bridge
Notes Financing
On
September 24, 2024, the Company entered into a purchase agreement with certain purchasers for the private placement of $3.9 million of
convertible notes (the “Bridge Notes”). The Bridge Notes bear interest at 12% per year, payable quarterly in arrears. At
the Company’s election, it may pay interest either in cash or in-kind by increasing the outstanding principal amount of the Bridge
Notes. The Bridge Notes mature on the one-year anniversary of the date of their issuance, unless earlier converted or repurchased. The
Company does not have the option to redeem any of the Bridge Notes prior to maturity. The Bridge Notes financing closed on September
24, 2024.
The
only conversion event for the Bridge Notes is upon stockholder approval at the Company’s annual meeting of stockholders on October
29, 2024 (the “Annual Meeting), in which case, 100% of the principal amount of the Bridge Notes plus all accrued and unpaid interest
thereon and, interest that would have accrued on the principal amount through December 24, 2024, will automatically convert into shares
of the Company’s common stock at a conversion price of $0.50. Otherwise, the Bridge Notes may be paid in cash upon maturity.
The Bridge Notes
have the same customary events of default provision as the Convertible Notes. As of September 30, 2024, there were no events of default
that occurred under any of the Bridge Notes.
The
Company was required to bifurcate the conversion feature from the Bridge Notes and record it as a derivative liability at its fair
value. The Company determined the fair value of the derivative liability by taking the difference between the fair value of the
Bridge Notes with the conversion feature and without the conversion feature, which resulting in the Company recording a $5.5
million derivative liability, with a corresponding $3.9
million reduction in the carrying value of the Bridge Notes recorded as a debt discount
and a $1.6
million charge to expense for the incremental fair value of the derivative liability as of September 24, 2024. The debt discount is are amortized over the
contractual terms of the Bridge Note as a component of interest expense.
At September 30, 2024, the Company
remeasured the fair value of the Bridge Notes derivative liability and recorded a reduction in the liability of $0.6 million. The corresponding credit of $0.6 million is recorded as a component of the fair value adjustments to Bridge
Notes derivative liability on the accompanying condensed consolidated statement of operations for the three and nine months ended September
30, 2024, which also includes the $1.6 million incremental expense noted above.
Exchange
Transaction
On
September 24, 2024, the Company entered into exchange agreements (the “Exchange Agreements”) with the holders of (i) warrants
to purchase an aggregate of approximately 4.4 million shares of our common stock the Company issued in December 2022 with an exercise
price of $1.43 per share (the “December 2022 warrants”); (ii) the July 2023 convertible notes and July 2023 warrants; and
(iii) the December 2023 convertible notes and the December 2023 warrants (the “Exchange Transactions”). The parties to the
Exchange Agreements represent the holders of all the outstanding convertible notes and all the outstanding warrants described above except
for a December 2022 warrant to purchase approximately 0.1 million shares of our common stock.
Subject
to approval by the Company’s stockholders at the Annual Meeting, under the Exchange Agreements (i) the holders of the warrants
agreed to exchange all their warrants for shares of the Company’s common stock at an exchange ratio of 0.5 of a share of common
stock for every one share of common stock issuable upon exercise of the applicable warrant (rounded up to the nearest whole number),
and (ii) the holders of the convertible notes agreed to exchange all their convertible notes for shares of the Company’s common
stock at an exchange ratio equal to (A) the sum expressed in U.S. dollars of (1) the principal amount of the applicable convertible note,
plus (2) all accrued and unpaid interest thereon through the date the applicable convertible note is exchanged plus (3) all interest
that would have accrued through, but not including, the maturity date of applicable convertible note if it was outstanding from the date
such convertible note is exchanged through its maturity date (the sum of (A) totaling approximately $28.4 million), divided by (B) $1.00
(rounded up to the nearest whole number) (the “Exchange Transactions”).
The
Company determined that the modifications to the convertible notes should be accounted for as an extinguishment of debt because there
was at least a 10% change in the cash flows of the modified debt instrument compared to the carrying amount of the original debt instrument,
and as such, the difference between the reacquisition price (which includes any premium) and the net carrying amount of the debt being
extinguished (which includes any deferred debt issuance costs) should be recognized as a gain or loss when the debt is extinguished.
As
of September 24, 2024, prior to entering into the Exchange Agreements, there was approximately $10.1 million of net carrying amount of
the convertible notes, which was comprised of $19.4 million of principal and accrued interest through such date, offset by approximately
$9.3 million of unamortized debt issuance costs. The fair value of the reacquired convertible notes was $32.0 million and was determined
by multiplying approximately 28,351,000 shares the Company would be issuing on October 29, 2024 by the closing stock price of $1.13 per
share on September 24, 2024. The difference between the reacquisition price and the net carrying amount of the convertible notes being
extinguished was approximately $21.9 million. Accordingly, the Company increased the carrying value of the reacquired convertible notes
to $32.0 million and recognized a loss on extinguishment of debt of approximately $21.9 million during the three and nine months ended
September 30, 2024.
Because shareholder approval was required for the Exchange Transactions
to occur, the Company determined that the modifications to the warrants resulted in a change in classification of such warrants from equity
to liability. A provision that requires shareholder approval precludes equity classification because such approval is not an input into
a fixed-for-fixed valuation model. As a result, the Company recorded the warrants at fair value as of September 24, 2024 by taking the
number of shares of common stock issuable from the exchanged warrants multiplied by the closing stock price of $1.13 and reclassified
approximately $11.2 million from equity to warrant liabilities. The Company then marked-to-market the warrants as of September 30, 2024
by taking the same quantity of shares multiplied by the closing stock price on such date and recognized a reduction to the warrant liabilities
of $0.8 million. A corresponding credit of $0.8 million was recognized as a change in fair value of warrant liabilities for the three
and nine months ended September 30, 2024 on the accompanying condensed consolidated statement of operations.
Equity
Financing
On
September 24, 2024, the Company entered into a securities purchase agreement (the “SPA”) with certain accredited investors
to sell in a private placement an aggregate of approximately 1,517,000 shares of the Company’s common stock (or, in lieu thereof,
pre-funded warrants to purchase one share of our common stock) for a purchase price of $0.75 per share of common stock and $0.745 per pre-funded warrant (the “Common Stock Private Placement” and together with the Bridge Notes
and the Exchange Transactions, the “September 2024 Transactions”). The closing of the Common Stock Private Placement was
conditioned upon receiving stockholder approval at the Annual Meeting.
The
SPA represents a forward sale contract obligating the Company to sell a fixed number of shares of its common stock at a fixed price per
share upon obtaining shareholder approval at the Annual Meeting. The Company measured the fair value of the forward sale contract as
the difference between (A) the fair value of the expected shares to be purchased by the investors as of the date the Company entered
into the SPA and (B) the purchase price of the shares, and recorded approximately $0.6 million to additional paid-in capital as of September
24, 2024. Because of the concurrent execution of the SPA and the Exchange Agreements, and because the investors in the SPA are also parties
to the Exchange Transactions, the $0.6 million was added to the $21.9 million loss on extinguishment of debt discussed above for a total
loss of $22.4 million during the three and nine months ended September 30, 2024.
On
October 29, 2024, the Company held its Annual Meeting, the Company’s stockholders approved the September 2024 Transactions, and
as a result, the following occurred on October 29, 2024:
| ● | Under
the Common Stock Private Placement, the Company issued approximately 1,402,000 shares of
common stock and pre-funded warrants to purchase 115,000 shares of common stock and received
approximately $1.1 million in gross proceeds from the issuance of such securities. The pre-funded
warrants have an exercise price of $0.005 per share, are exercisable at any
time and will not expire until exercised in full. |
| | |
| ● | Under
the Bridge Notes, approximately $3.0 million of the principal amount of the bridge notes
plus all accrued and unpaid interest thereon, plus such amount of interest that would have
accrued on the principal amount through December 24, 2024, was automatically converted at
a conversion price of $0.50 into approximately 6,244,000 shares of the Company’s common
stock and approximately $0.9 million of the principal amount of the bridge notes plus all
accrued and unpaid interest thereon, plus such amount of interest that would have accrued
on the principal amount through December 24, 2024, was automatically converted at a conversion
price of $0.50 into pre-funded warrants to purchase 1,764,000 shares of common stock. The
pre-funded warrants have an exercise price of $0.005 per share, are exercisable
at any time and will not expire until exercised in full. As of October 29, 2024, there were
no Bridge Notes outstanding. |
| | |
| ● | Under
the Exchange Transactions, (i) the holders of the warrants exchanged approximately 19,902,000
warrants for approximately 9,951,000 shares of the Company’s common stock, and (ii)
the holders of the convertible notes exchanged all their convertible notes for approximately
28,351,000 shares of our common stock for a total of 38,302,000 shares of our common stock
under the Exchange Transactions. As of October 29, 2024, there were no Convertible Notes
outstanding. |
6) | FAIR
VALUE OF FINANCIAL INSTRUMENTS |
Fair
value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between
willing market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted
prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy
is as follows:
●
Level 1 Inputs – Valued based on quoted prices in active markets for identical assets or liabilities that the reporting entity
has the ability to access at the measurement date.
●
Level 2 Inputs – Valued based on inputs other than quoted prices included in Level 1 that are observable for the asset or
liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets,
quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that
are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs
that are derived principally from or corroborated by market data by correlation or other means.
●
Level 3 Inputs – Valued based on inputs for which there is little or no market value, which require the reporting entity to
develop its own assumptions.
The
carrying amounts reported on the balance sheet for cash, other receivable, prepaid assets and other current assets, accounts payable
and accrued expenses, other current liabilities and other liabilities approximate fair value based due to their short maturities.
The
Company issued approximately 343,000 warrants in connection with a private placement during the first quarter of 2022 (the “Q1-22
warrants”), which were determined to be classified as a liability. The Company also recorded the Market Cap Contingent Consideration
liability related to the Exacis Acquisition. See Note 3 for more information related to the Exacis Acquisition.
In
connection with the Bridge Notes, the Company recorded a derivative liability as of September 24, 2024. In connection with the Exchange
Transactions, on September 24, 2024, the Company reclassified the warrants included in the Exchange Transactions from equity to a liability.
See Note 5 for more information related to the Bridge Notes and Exchange Transactions.
The
Company uses a Black-Scholes option pricing model to estimate the fair value of the Q1-22 warrant liabilities and a Monte Carlo simulation
model to estimate the fair value of the contingent consideration related to the Market Cap Contingent Consideration, both of which are
considered a Level 3 fair value measurement.
The
Company determined the fair value of the derivative liability by taking the difference between the fair value of the Bridge Notes with
the conversion feature and without the conversion feature.
With
respect to the warrants in the Exchange Transactions, the Company determined the fair value of the warrants as of September 24, 2024
by taking the number of shares of common stock issuable from the exchanged warrants multiplied by the closing stock price of $1.13 and
reclassified approximately $11.2 million from equity to warrant liabilities.
The Company remeasures the fair value of the warrant liabilities, the Bridge Notes derivative liability and the Market Cap Contingent
Consideration at each reporting period and changes in the fair values are recognized in the statement of operations.
The
following tables summarize the liabilities that are measured at fair value as of September 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE
Description | |
Level | | |
September 30, 2024 | | |
December 31, 2023 | |
Liabilities: | |
| | | |
| | | |
| | |
Warrant liabilities - Q1-22 warrants | |
| 3 | | |
$ | 15 | | |
$ | 116 | |
Warrant liabilities – Exchange Transactions | |
| 3 | | |
$ | 10,448 | | |
$ | - | |
Bridge Notes derivative liability | |
| 3 | | |
$ | 4,926 | | |
$ | - | |
Market Cap Contingent Consideration | |
| | | |
| - | | |
| - | |
Liability fair value disclosure | |
| | | |
| - | | |
| - | |
Certain
inputs used in Black-Scholes and Monte Carlo models may fluctuate in future periods based upon factors that are outside of the Company’s
control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change
to the fair value of the Company’s warrant liabilities or contingent consideration liabilities, which could also result in material
non-cash gains or losses being reported in the Company’s condensed consolidated statement of operations.
The
following table presents the changes in the liabilities measured at fair value from January 1, 2024 through September 30, 2024 (in thousands):
SCHEDULE
OF CHANGES IN WARRANT LIABILITIES
| |
Warrant Liabilities | |
|
Derivative
Liability |
| |
Contingent Consideration | |
| |
| |
|
|
| |
| |
Fair value at January 1, 2024 | |
$ | 116 | |
|
$ |
- |
| |
$ | 107 | |
Reclassification of warrants from equity to liability | |
| 11,244 | |
|
|
- |
| |
| - | |
Initial measurement of Bridge Notes derivative liability | |
| - | |
|
|
5,566 |
| |
| - | |
Change in fair value | |
| (897 | ) |
|
|
(640 |
) | |
| (66 | ) |
Fair value at September 30, 2024 | |
$ | 10,463 | |
|
$ |
4,926 |
| |
$ | 41 | |
The
Company assessed the fair value of the Market Cap Contingent Consideration at September 30, 2024 and determined that there were no material
changes to the inputs used in the June 30, 2024 remeasurement that would have resulted in a material change to the liability at September
30, 2024. Therefore, the Company did not recognize a change in fair value of the Market Cap Contingent Consideration for the three months
ended September 30, 2024.
The
Company remeasured the Bridge Notes derivative
liability by taking the difference between the fair value of the Bridge Notes with the conversion feature and without the conversion feature
as of September 30, 2024 and recorded a $0.6 million credit for the change in fair value during the three months ended September 30, 2024.
The
table below is provided for comparative purposes only and presents information about the fair value of the Company’s convertible
notes relative to the carrying values recognized in the condensed consolidated balance sheet as of September 30, 2024 and December 31,
2023 (in thousands).
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES
| |
| | |
September 30, 2024 | | |
December 31, 2023 | |
| |
Level | | |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
Convertible Notes | |
| 3 | | |
$ | 32,037 | | |
$ | 29,768 | | |
$ | 16,616 | | |
$ | 17,594 | |
Bridge Notes | |
| 3 | | |
$ | 3,887 | | |
$ | 8,409 | | |
$ | - | | |
$ | - | |
The
carrying value of the Convertible Notes in the table above is reflective of the reacquisition price of the Convertible Notes as a
result of the Exchange Agreements entered into on September 24, 2024, which was recorded at its fair value as of September 24, 2024. The Company determined the fair value of the Convertible Notes by multiplying the 28.4 million shares expected to
be issued in common stock on October 29, 2024 by the closing stock price of $1.05 per share on September 30, 2024.
The
carrying value of the Bridge Notes in the table above is shown before the bifurcation of the Bridge Notes derivative liability. The Company
determined the fair value of the Bridge Notes by multiplying the 8.0
million shares expected to be issued in common stock (or in pre-funded warrants)
on October 29, 2024 by the closing stock price of $1.05
per share on September 30, 2024.
See
Note 5 for more information on the Convertible Notes and the Bridge Notes.
The
Company assessed the fair value of the 2023 convertible notes as of December 31, 2023 using a binomial model, which is considered a Level
3 measurement.
In
2018, the Company acquired IRX Therapeutics (“IRX”), which was accounted for as a business combination. The Company recorded
goodwill in the amount of $2.0 million related to the IRX acquisition. Goodwill is not amortized but is tested for impairment annually,
or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value
of the entity is less than its carrying value. As of September 30, 2024, the Company did not identify potential triggering events that
could indicate that the fair value of the entity is less than its carrying value and determined there were no such events that occurred.
The
Company currently has operating leases for office in the borough of Manhattan in New York, New York, and Cambridge,
Massachusetts, which expire in 2026 and 2028, respectively.
In
addition, in October 2022, the Company entered into a sublease with a subsidiary of Bristol-Myers Squibb Company, as sublessor (“Sublessor”),
for office, laboratory and research and development space of approximately 45,500 square feet in Somerville, Massachusetts. The sublease
provided for base rental payments of approximately $0.5 million per month as well as monthly payments for parking and the Company’s
share of traditional lease expenses, including certain taxes, operating expenses and utilities. The Company paid the Sublessor a security
deposit in the form of a letter of credit in the amount of approximately $4.1 million.
On
May 3, 2024, the Company received a notice from the Sublessor regarding past due rent payments of approximately $2.3 million, including
amounts related to property taxes and common area maintenance costs, that the Company did not pay for the months of February, March,
April and May 2024. Failure to pay the past due rent payments in full, plus approximately $70,000 in late fees and interest, within five
business days from the date of the notice constitutes an event of default under the sublease.
The
Company also did not pay the rent for June, July or August 2024 and, as of August 1, 2024, owed approximately $4.0 million in the aggregate
in past due rent. On August 5, 2024, the Sublessor drew down on the letter of credit for the full $4.1 million to cover the approximately
$4.0 million of past due rent payments, plus interest and penalties.
On
August 9, 2024, the Company and Sublessor entered into a sublease termination agreement, effective August 31, 2024. The sublease was
originally scheduled to expire in 2033. Pursuant to the sublease termination agreement, the Company agreed to the following: to surrender
and vacate the premises; that the Company’s right, title and interest in all furniture, fixtures and laboratory equipment at the
premises will become the property of the sublessor; and that both parties will be released of their obligations under the sublease. As
a result of the sublease termination, the Company recognized a gain on lease termination of approximately $1.6 million for the three
and nine months ended September 30, 2024, which includes a loss on disposal of fixed assets of approximately $0.5 million.
For
the three and nine months ended September 30, 2024 and 2023, the net operating lease expenses were as follows (in thousands):
NET
OPERATING LEASE EXPENSE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease expense | |
$ | 1,110 | | |
$ | 1,623 | | |
$ | 4,380 | | |
$ | 1,758 | |
Sublease income | |
| (21 | ) | |
| (21 | ) | |
| (63 | ) | |
| (63 | ) |
Variable lease expense | |
| 225 | | |
| 6 | | |
| 887 | | |
| 18 | |
Total lease expense | |
$ | 1,314 | | |
$ | 1,608 | | |
$ | 5,204 | | |
$ | 1,713 | |
The
tables below show the beginning balances of the operating ROU assets and lease liabilities as of January 1, 2024 and the ending balances
as of September 30, 2024, including the changes during the period (in thousands).
OPERATING
LEASE RIGHT-OF-USE ASSETS AND LIABILITIES
| |
Operating Lease ROU Assets | |
| |
| |
Operating lease ROU assets at January 1, 2024 | |
$ | 32,781 | |
Adjustment to ROU asset for remeasurement of | |
| | |
Somerville Sublease liability | |
| 4,245 | |
Write-off of Somerville Sublease ROU asset | |
| (34,857 | ) |
Amortization of operating lease ROU assets | |
| (1,450 | ) |
Operating lease ROU assets at September 30, 2024 | |
$ | 719 | |
| |
Operating Lease Liabilities | |
Operating lease liabilities at January 1, 2024 | |
$ | 35,070 | |
Adjustment to lease liability due to remeasurement of Somerville Sublease | |
| 4,245 | |
Accretion of interest for Somerville Sublease | |
| 2,465 | |
Write-off of Somerville Sublease liability | |
| (36,924 | ) |
Principal payments on operating lease liabilities | |
| (4,121 | ) |
Operating lease liabilities at September 30, 2024 | |
| 735 | |
Less non-current portion | |
| 534 | |
Current portion at September 30, 2024 | |
$ | 201 | |
As
of September 30, 2024, the Company’s operating leases had a weighted-average remaining life of 3.3 years with a weighted-average
discount rate of 10.23%. The maturities of the operating lease liabilities are as follows (in thousands):
MATURITIES
OF OPERATING LEASE LIABILITIES
| |
As of September 30, 2024 | |
2024 | |
$ | 69 | |
2025 | |
| 274 | |
2026 | |
| 267 | |
2027 | |
| 163 | |
2028 | |
| 82 | |
Total payments | |
| 855 | |
Less imputed interest | |
| (120 | ) |
Total operating lease liabilities | |
$ | 735 | |
Accrued
expenses at September 30, 2024 and December 31, 2023 consisted of the following (in thousands):
SCHEDULE
OF ACCRUED EXPENSES
| |
September 30, 2024 | | |
December 31,
2023 | |
Professional fees | |
$ | 290 | | |
$ | 239 | |
Legal fees | |
| 267 | | |
| 643 | |
Accrued compensation | |
| 108 | | |
| 109 | |
Convertible notes interest | |
| 38 | | |
| 176 | |
Somerville facility | |
| - | | |
| 218 | |
Other | |
| 463 | | |
| 508 | |
Total accrued expenses | |
$ | 1,166 | | |
$ | 1,893 | |
10) | RELATED
PARTY TRANSACTIONS |
Agreements
with Factor Bioscience Inc. and Affiliates
As
of September 30, 2024, the Company had entered into the agreements described below with Factor Bioscience Inc. and/or Dr. Matthew
Angel. These agreements have been deemed related party transactions because the Company’s former chief executive officer, Dr.
Angel, is the chairman and chief executive officer of Factor Bioscience Inc. and a director of its subsidiary, Factor Bioscience
Limited (“Factor Limited” and together with Factor Bioscience Inc. and its other affiliates, “Factor
Bioscience”). Dr. Angel resigned as the Company’s chief executive officer effective December 31, 2023.
In
September 2022, the Company entered into a Master Services Agreement (the “MSA”) with Factor Bioscience, pursuant to which
Factor Bioscience agreed to provide services to the Company as agreed between the Company and Factor Bioscience and as set forth in one
or more work orders under the MSA, including the first work order included in the MSA (“WO1”). The MSA contains customary
confidentiality provisions and representations and warranties of the parties, and the MSA may be terminated by either party upon 30 days’
prior notice, subject to any superseding termination provisions contained in a particular work order.
Under
WO1, Factor Bioscience agreed to provide the Company with mRNA cell engineering research support services, including access to certain
facilities, equipment, materials and training, and the Company agreed to pay Factor Bioscience an initial fee of $5.0 million, payable
in 12 equal monthly installments of approximately $0.4 million. Of the $5.0 million, the Company allocated $3.5 million to the License
Fee Obligation (as defined below). Following the initial 12-month period, the Company agreed to continue paying Factor Bioscience the
monthly fee of $0.4 million until such time as WO1 is terminated. Upon entering into the MSA, the Company paid a deposit of $0.4 million,
which will be applied to the last month of WO1.
Under
the terms of an amendment to WO1, the Company may terminate WO1 on or after the second anniversary of the date of the MSA, subject to
providing Factor Bioscience with 75 days’ prior notice if such notice is provided no later than June 30, 2024. On June 26, 2024,
the Company provided Factor Bioscience with its notice to terminate WO1, which became effective on September 9, 2024.
In
connection with entering into the MSA, Factor Limited entered into a waiver agreement with Eterna LLC, pursuant to which Factor Limited
agreed to waive payment of $3.5 million otherwise payable to it (the “License Fee Obligation”) in October 2022 by Eterna
LLC under the exclusive license agreement entered into in April 2021 among Eterna LLC, Novellus Limited and Factor Limited (the
“Original Factor License Agreement”). Under the waiver agreement, the License Fee Obligation is waived conditionally
on the Company paying Factor Bioscience a minimum of $3.5 million due under the MSA.
Because
the License Fee Obligation was conditionally waived until the Company paid Factor Bioscience a minimum of $3.5 million under the MSA,
the Company recorded a liability of $3.5 million. As of September 30, 2024, there was no License Fee Obligation liability remaining.
In
September 2022, Novellus Inc. (“Novellus”) and the Company entered into a Second Amendment to the Limited Waiver and Assignment
Agreement (the “Waiver and Assignment Agreement”) with Drs. Matthew Angel and Christopher Rohde (the “Founders”)
whereby the Company agreed to be responsible for all future, reasonable and substantiated legal fees, costs, settlements and judgments
incurred by the Founders, the Company or Novellus for certain claims and actions and any pending or future litigation brought against
the Founders, Novellus and/or the Company by or on behalf of the Westman and Sowyrda legal matters described in Note 10 (the “Covered
Claims”). The Founders will continue to be solely responsible for any payments made to satisfy a judgement or settlement of any
pending or future wage act claims. Under the Waiver and Assignment Agreement, the Founders agreed that they are not entitled to, and
waived any right to, indemnification or advancement of past, present or future legal fees, costs, judgments, settlement or other liabilities
they may have been entitled to receive from the Company or Novellus in respect of the Covered Claims. The Company and the Founders will
share in any recoveries up to the point at which the parties have been fully compensated for legal fees, costs and expenses incurred,
with the Company retaining any excess recoveries. The Company has the sole authority to direct and control the prosecution, defense and
settlement of the Covered Claims.
In
November 2022, following the expiration of one of the milestone deadlines for certain regulatory filings required under the Third Amended
and Restated Exclusive License Agreement between Novellus Limited and Factor Limited entered into in November 2020 (the “Novellus-Factor
License Agreement”), which permitted Factor Limited to terminate the license granted to Novellus Limited thereunder, the Company
entered into the first amendment to the Original Factor License Agreement (as amended, the “2021 Factor License Agreement”),
pursuant to which, among other things, Factor Limited granted to Eterna LLC an exclusive, sublicensable license under certain patents
owned by Factor Limited (the “Factor Patents”) for the purpose of identifying and pursuing certain opportunities to grant
to third parties sublicenses to the Factor Patents. The Original Factor License Agreement also (i) terminated the Novellus-Factor License
Agreement, (ii) confirmed Factor Limited’s grant to Eterna LLC of the rights and licenses Novellus Limited previously granted to
Eterna LLC under the Novellus-Factor License Agreement on the same terms and conditions as granted by Novellus Limited to Eterna LLC
under such agreement, (iii) confirmed that the sublicense granted by Novellus Limited in accordance with the Novellus-Factor License
Agreement to NoveCite, Inc., a company which the Company has a 25% non-controlling interest (“NoveCite”), survived termination
of the Novellus-Factor License Agreement; and (iv) removed Novellus Limited from the Original Factor License Agreement and the license
agreement entered into on October 6, 2020 between Novellus Limited and NoveCite, Inc, as amended, and replaced Novellus Limited with
Factor Limited as the direct licensor to Eterna LLC and NoveCite under such agreements, respectively.
On
February 20, 2023, the Company, entered into an exclusive license agreement (the “Feb 2023 Factor Exclusive License Agreement”)
with Factor Limited, pursuant to which Factor Limited granted to the Company an exclusive, sublicensable, worldwide license under certain
patents owned by Factor Limited for the purpose of, among other things, identifying and pursuing certain opportunities to develop products
in respect of such patents and to otherwise grant to third parties sublicenses to such patents. The Feb 2023 Factor Exclusive License
Agreement, which terminated and superseded the Amended Factor License Agreement, was subsequently terminated and superseded by the A&R
Factor License Agreement (as defined below).
On
November 14, 2023, the Company entered into an amended and restated exclusive license agreement (the “A&R Factor License Agreement”)
with Factor Limited to replace in its entirety the exclusive license agreement between the parties dated February 20, 2023 and the amendment
thereto. Under the A&R Factor License Agreement, Factor Limited granted to the Company an exclusive, sublicensable license
under certain patents owned by Factor Limited (the “Factor Patents”). The A&R Factor License Agreement also provides
for, among other things, the expansion of the Company’s license rights to include (i) the field of use of the Factor Patents to
include veterinary uses (ii) know-how that is necessary or reasonably useful to practice to the licensed patents, (iii) the ability to
sublicense through multiple tiers (as opposed to only permitting a direct sublicense) and (iv) the transfer of technology to the Company,
subject to the use restrictions in the A&R Factor License Agreement. The A&R Factor License Agreement was subsequently terminated
and superseded by the Factor L&C Agreement discussed below.
On
September 24, 2024, the Company entered into the Factor L&C Agreement, effective as of September 9, 2024, with Factor Limited. The
Factor L&C Agreement terminated the A&R Factor License Agreement as well as the Purchased License that Exacis entered into with
Factor Bioscience on November 4, 2020, which the Company acquired pursuant to the Exacis Purchase Agreement with Exacis and certain stockholders
of Exacis on April 26, 2023.
Under
the Factor L&C Agreement, the Company has obtained exclusive licenses in the fields of cancer, autoimmune disorders, and rare diseases
with respect to certain licensed technology and has the right to develop the licensed technology directly or enter into co-development
agreements with partners who can help bring such technology to market. The Factor L&C Agreement also provides for certain services
and materials to be provided by Factor Bioscience to facilitate the development of the licensed technology and to enable the Company
to scale up production at third party facilities.
The
initial term of the Factor L&C Agreement is one year after the effective date, and it automatically renews yearly thereafter. The
Company may terminate the Factor L&C Agreement for any reason upon 90 days’ written notice to Factor Bioscience, and the parties
otherwise have customary termination rights, including in connection with certain uncured material breaches and specified bankruptcy
events.
Pursuant
to the Factor L&C Agreement, the Company will pay Factor Bioscience approximately $0.2 million per month for the first twelve months,
approximately $0.1 million per month for the first nine months toward patent costs, certain milestone payments, royalty payments on net
sales of commercialized products and sublicensing fee payments.
Exacis
Asset Acquisition
On
April 26, 2023, the Company closed the Exacis Acquisition. See Note 3 for additional information.
The
Exacis Acquisition was deemed a related party transaction because, at the time of the acquisition, (i) Dr. Gregory Fiore was both the
chief executive officer of Exacis and a member of the Company’s board of directors, (ii) Dr. Angel was both the Company’s
chief executive officer and chairman of Exacis’ scientific advisory board, and (iii) an affiliate of Factor Bioscience was the
majority stockholder of Exacis.
Consulting
Agreement with Former Director
In
May 2023, the Company entered into a consulting agreement with Dr. Fiore, whereby Dr. Fiore agreed to provide business development consulting
services to the Company for a monthly retainer of $20,000. The consulting agreement was terminable for any reason by either party upon
15 days’ written notice. The Company terminated the consulting agreement, effective July 31, 2023. Dr. Fiore served on the Company’s
board of directors from June 2022 to October 4, 2023.
July
2023, December 2023 and September 2024 Financings
Investors
in the July 2023 convertible note financing included Brant Binder, Richard Wagner, Charles Cherington and Nicholas Singer, and investors
in the December 2023 convertible note financing and the September 2024 financing included Messrs. Cherington and Singer. Each of them
participated in the applicable financing under the same terms and subject to the same conditions as all the other investors. See Note
5 and Note 17 for additional information regarding the financings. Mr. Binder served on the Company’s board of directors from July
6, 2023 to August 8, 2023, Mr. Wagner served on the Company’s board of directors from July 6, 2023 to August 8, 2023, Mr. Cherington
served on the Company’s board of directors from March 2021 to July 6, 2023, and Mr. Singer served on the Company’s board
of directors from June 2022 to July 6, 2023.
11) | COMMITMENTS
AND CONTINGENCIES |
Litigation
Matters
The
Company is involved in litigation and arbitrations from time to time in the ordinary course of business. Legal fees and other costs associated
with such actions are expensed as incurred. In addition, the Company assesses the need to record a liability for litigation and contingencies.
The Company reserves for costs relating to these matters when a loss is probable, and the amount can be reasonably estimated.
Novellus,
Inc. v. Sowyrda et al., C.A. No. 2184CV02436-BLS2
On
October 25, 2021 Novellus, Inc. filed a complaint in the Superior Court of Massachusetts, Suffolk County, against former Novellus, Inc.
employees Paul Sowyrda and John Westman and certain other former investors in Novellus LLC (Novellus, Inc.’s former parent company
prior to our acquisition of Novellus, Inc.), alleging breach of fiduciary duty, breach of contract and civil conspiracy. Eterna acquired
Novellus, Inc. on July 16, 2021. On May 27, 2022 Novellus, Inc. amended the complaint to withdraw all claims against all defendants except
Paul Sowyrda and John Westman. On July 1, 2022, Westman filed a motion to compel arbitration or in the alternative, to stay the litigation
pending the disposition of certain litigation in the Court of Chancery for the State of Delaware filed by Mr. Sowyrda against Novellus
LLC, Dr. Christopher Rohde, Dr. Matthew Angel, Leonard Mazur and Factor Bioscience, Inc. captioned Zelickson et al., v. Angel et al.,
C.A. 2021-1014-JRS and by Westman against Novellus LLC captioned Westman v. Novellus LLC, C.A. No. 2021-0882-NAC (together,
the “Delaware Actions”). On July 1, 2022, Sowyrda answered the complaint and asserted counterclaims against Novellus, Inc,
and third-party defendants Dr. Matthew Angel and Dr. Christopher Rohde alleging violations of the Massachusetts Wage Act, Massachusetts
Minimum Fair Wage Law, the Fair Labor Standards Act, breach of contract, unjust enrichment and quantum meruit. Sowyrda also joined in
Westman’s motion to stay the case pending the Delaware Actions. Novellus, Inc.’s claims and Mr. Sowyrda’s counterclaims
relate to alleged conduct that took place before Eterna acquired Novellus, Inc.
On
November 15, 2022, prior to a decision on Westman’s and Sowyrda’s motion to compel or stay, the parties agreed to voluntarily
dismiss and consolidate the Delaware Actions with this action. On December 15, 2022, Sowyrda filed an Amended Answer to the Amended Complaint,
asserted affirmative defenses and filed Amended Counterclaims against Dr. Angel, Dr. Rohde, Novellus LLC, Novellus Inc., Factor Bioscience
Inc., and Eterna Therapeutics Inc. (collectively, the “Counterclaim Defendants”) alleging against various Counterclaim Defendants
breach of contract, breaches of the implied duty of good faith and fair dealing, breaches of fiduciary duty, breaches of the operating
agreement, aiding and abetting breaches of fiduciary duty, tortious interference with contract, equitable accounting, violations of the
Massachusetts Wage Act, Massachusetts Minimum Fair Wage Law, the Fair Labor Standards Act, unjust enrichment, and quantum meruit. Also
on December 15, 2022, Westman filed an answer to the Amended Complaint and asserted similar counterclaims against the same Counterclaim
Defendants. Westman and Sowyrda each asserted claims for indemnification and/or advancement against Novellus, Inc. On January 11, 2023,
Westman and Sowyrda served a joint motion to enforce their advancement and/or indemnification rights against Novellus Inc. Novellus Inc.
vigorously opposes this motion and served its opposition on January 27, 2023. On February 8, 2023, Westman and Sowyrda served a reply
in support of their motion to enforce indemnification/advancement rights, and submitted the motion to the Court. Novellus Inc. answered
Westman and Sowyrda’s counterclaims on January 27, 2023, denying liability. The remaining Counterclaim Defendants served a motion
to dismiss most of the remaining counterclaims on January 27, 2023. The Court entered an order granting the Counterclaim Defendants’
motion to dismiss and denying Sowyrda and Westman’s motion to enforce on June 15, 2023. The Court’s order dismissed all of
Westman’s claims against Counterclaim Defendants except his claim for indemnification, and all of Sowyrda’s claims except
his claim for indemnification and his employment-related claims, which Counterclaim Defendants did not move to dismiss. On July 6, 2023,
Westman and Sowyrda filed a petition for interlocutory review with a single justice of the Massachusetts Appeals Court, seeking to overturn
the judge’s decision granting the Counterclaim Defendants’ motion to dismiss most of the remaining counterclaims, but not
the decision denying Westman and Sowyrda’s motion to enforce advancement rights. On July 25, 2023, the parties to the appeal filed
a joint motion to the single justice in the appellate court to stay the appeal to allow for amended counterclaims to be filed by Counterclaim
Plaintiffs and a motion to dismiss to be filed by Counterclaim Defendants. Counterclaim Plaintiffs filed an initial set of amended counterclaims
on August 15, 2023. Counterclaim Plaintiffs amended and refiled their amended counterclaims on September 29, 2023. Counterclaim Defendants
served their motion to dismiss all of the amended counterclaims, except for Sowyrda’s employment-related claims, on October 13,
2023. On June 13, 2024, the motion to dismiss was denied and the court set a schedule for discovery limited to a threshold factual issue.
Discovery as to all other issues pertaining to the counterclaims was stayed. On July 15, 2024, Westman and Sowyrda requested that the
single justice in the appellate court continue to stay the appeal pending the outcome of the limited discovery ordered by the Court.
On July 31, 2024, Counterclaim Defendants and Sowyrda informed the Court that they had reached a settlement and requested that all claims
pending between them be dismissed with prejudice, and on August 9, 2024, the Court approved the motion for approval of dismissal of all
such claims with prejudice. Pursuant to the Court’s order, Counterclaim Defendants are engaged in limited discovery with Westman..
The next Court conference is scheduled for November 18, 2024.
Under
applicable Delaware law and Novellus Inc.’s organizational documents, the Company may be required to advance or reimburse certain
legal expenses incurred by former officers and directors of Novellus, Inc. in connection with the foregoing Westman and Sowyrda matters.
However, a future advance or reimbursement is not currently probable nor can it be reasonably estimated.
eTheRNA
Immunotherapies NV and eTheRNA Inc. v. Eterna Therapeutics Inc. C.A. No. 123CV11732
On
July 31, 2023, eTheRNA Immunotherapies NV and eTheRNA Inc. filed a complaint against the Company alleging the following claims: (1) federal
trademark infringement; (2) federal unfair competition; (3) Massachusetts state common law trademark infringement; (4) Massachusetts
state unfair competition. On April 2, 2024, the parties settled the claims and stipulated to dismiss the complaint with prejudice. Per
the settlement agreement entered into between the parties on March 19, 2024, the Company plans to phase-out its current use of the ETERNA
trademark by October 31, 2024.
On
October 6, 2024, the parties entered into an addendum to the settlement agreement extending the deadline for phasing out the Company’s
use of the ETERNA trademark until March 31, 2025. If the Company continues to use the Eterna Therapeutics name as of April 1, 2025, it
will be obligated to pay €667 per day that it continues to do so.
Licensing
Agreements
On
September 24, 2024, the Company entered into the Factor L&C Agreement. See Note 10 for details of this agreement.
Retirement
Savings Plan
The
Company established a defined contribution plan, organized under Section 401(k) of the Internal Revenue Code, which allows employees
to defer up to 90% of their pay on a pre-tax basis. Beginning on January 1, 2023, the Company began matching employees’ contributions
at a rate of 100% of the first 3% of the employee’s contribution and 50% of the next 2% of the employee’s contribution, for
a maximum Company match of 4%.
12) | STOCK-BASED
COMPENSATION |
Stock
Options
During
the nine months ended September 30, 2024 and 2023, the Company granted options to purchase the number of shares of the Company’s
common stock set forth in the table below (in thousands):
SCHEDULE
OF STOCK OPTION GRANTED
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Stock options granted | |
| 2,375 | | |
| 237 | |
There
were no stock options granted during either of the three months ended September 30, 2024 or 2023.
On
January 1, 2024, Sanjeev Luther was appointed as President, Chief Executive Officer and a director of the Company. Upon his appointment,
he was granted a non-qualified stock option to purchase approximately 1,685,000 shares of the Company’s common stock. The stock
option has an exercise price of $1.80 per share, which was equal to the fair market value (as defined in the 2020 Restated Equity Incentive
Plan) of the Company’s common stock on the date of grant, will vest over four years, with 25% of the shares vesting on the first
anniversary of the grant date and the remaining 75% of the shares vesting in equal monthly installments over the three years thereafter,
in each case, subject to continued service. The stock option was granted pursuant to the terms of Mr. Luther’s employment agreement
and as a material inducement to his joining the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
On
April 26, 2024, the vesting terms of Mr. Luther’s stock option award were amended so that the option vests over three years,
with 25% of the shares vesting on the first anniversary of the grant date and the remaining 75% of the shares will vest in equal monthly
installments over the remaining two years, in each case, subject to continued service.
Since
the only modification to Mr. Luther’s stock option award was to the vesting terms, there was no change to the fair value of the
stock option and the total compensation cost was unchanged. However, the total compensation cost will be recognized over three years
rather than four years, and as a result, the Company recognized approximately $0.1 million in additional stock-based compensation expense
during the nine months ended September 30, 2024 as a result of the modification.
The
Company recognizes stock-based compensation expense for stock options granted to employees, directors and certain consultants. The Company
estimates the fair value of stock options using the Black-Scholes option pricing model. The fair value of stock options granted is recognized
as expense over the requisite service period on a straight-lined basis.
The
following weighted-average assumptions were used for stock options granted during the nine months ended September 30, 2024 and 2023:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS USED FOR STOCK OPTIONS GRANTED
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Weighted average risk-free rate | |
| 4.45 | % | |
| 3.82 | % |
Weighted average volatility | |
| 97.91 | % | |
| 95.15 | % |
Dividend yield | |
| 0.00 | % | |
| 0 | % |
Expected term | |
| 5.85 years | | |
| 5.44 years | |
The
per-share weighted average grant-date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 were
as follows:
SCHEDULE
OF WEIGHTED AVERAGE GRANT-DATE FAIR VALUE OF STOCK OPTIONS
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Weighted average grant date fair value | |
$ | 1.44 | | |
$ | 2.99 | |
Vesting
of all stock options is subject to continuous service with the Company through the applicable vesting date. As of September 30, 2024,
there were approximately 2,516,000 shares of the Company’s common stock subject to outstanding stock options.
Restricted
Stock Units
The
Company recognizes the fair value of RSUs as expense on a straight-line basis over the requisite service period. For performance-based
RSUs, the Company begins recognizing the expense once the achievement of the related performance goal is determined to be probable.
Outstanding
RSUs are settled in an equal number of shares of common stock on the vesting date of the award. An RSU award is settled only to the extent
vested. Vesting generally requires the continued employment or service by the award recipient through the applicable vesting date. Because
RSUs are settled in an equal number of shares of common stock without any offsetting payment by the recipient, the measurement of cost
is based on the quoted market price of the stock at the measurement date, which is the grant date.
In
lieu of paying cash to satisfy withholding taxes due upon the settlement of vested RSUs, at the Company’s discretion, an employee
may elect to have shares of common stock withheld that would otherwise be issued at settlement, the value of which is equal to the amount
of withholding taxes payable. During the three and nine months ended September 30, 2024 and 2023, less than 1,000 RSUs vested. As of
September 30, 2024, there were less than 1,000 RSUs outstanding.
The
Company did not grant RSUs during either of the three or nine months ended September 30, 2024 and 2023.
Stock-Based
Compensation Expense
For
the three and nine months ended September 30, 2024 and 2023, the Company recognized stock-based compensation expense as follows (in thousands):
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
| |
| | |
| | |
| | |
| |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 13 | | |
$ | 57 | | |
$ | 74 | | |
$ | 177 | |
General and administrative | |
| 392 | | |
| 117 | | |
| 1,036 | | |
| 900 | |
Total | |
$ | 405 | | |
$ | 174 | | |
$ | 1,110 | | |
$ | 1,077 | |
As
discussed in Notes
5 and 6, respectively, the Company has previously issued the note warrants and the Q1-22 warrants. The Company also has the December
2022 warrants outstanding from a private placement completed in the fourth quarter of 2022.
As
of September 30, 2024, the Company has the following warrants outstanding:
SCHEDULE
OF WARRANTS OUTSTANDING
| |
Warrants Outstanding (in thousands) | | |
Exercise Price | | |
Expiration Date | |
Classification |
Q1-22 warrants | |
| 343 | | |
$ | 38.20 | | |
September 9, 2027 | |
Liability |
December 2022 Warrants | |
| 4,370 | | |
$ | 1.43 | | |
June 2, 2028 | |
Equity |
July 2023 Note Warrants | |
| 6,094 | | |
$ | 1.43 | | |
July 14, 2028 | |
Equity |
December 2023 Note Warrant issued December 15, 2023 | |
| 8,115 | | |
$ | 1.43 | | |
December 15, 2028 | |
Equity |
December 2023 Note Warrant issued January 11, 2024 | |
| 1,464 | | |
$ | 1.43 | | |
January 11, 2029 | |
Equity |
| |
| 20,386 | | |
| | | |
| |
|
As
of September 30, 2024, the weighted average remaining contractual life of the warrants outstanding was 3.95 years and the weighted average
exercise price was $2.05.
On
October 29, 2024, all of the warrants except for the Q1-22 warrants and approximately 142,000 of the December 2022 Warrants were exchanged
for common stock at a rate of one-half share of common stock for every one warrant share pursuant to the Exchange Transactions. See Note
5 and 17 for more information regarding the Exchange Transactions.
The
Company calculates basic and diluted net loss per share attributable to common stockholders in conformity with the two-class method required
for participating securities. The convertible notes contractually entitle the holders thereof to participate in dividends but does not
contractually require the holders to participate in the Company’s losses. As such, the two-class method is not applicable during
periods with a net loss.
Basic
net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of
common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is
calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding
plus dilutive securities. Shares of common stock issuable upon exercise, conversion or vesting of outstanding stock options, RSUs, warrants
and shares of Series A convertible preferred stock are considered potential shares of common stock and are included in the calculation
of diluted net loss per share using the treasury method when their effect is dilutive. The outstanding convertible notes are also considered
potential shares of common stock and are included in the calculation of diluted net loss per share using the “if-converted”
method, and the more dilutive of either the two-class method or the if-converted method is reported. Diluted net loss per share is the
same as basic net loss per share for periods in which the effect of potentially dilutive shares of common stock is antidilutive.
The
following table presents the number of shares subject to outstanding warrants, stock options, RSUs, Series A convertible preferred stock
and convertible notes that were excluded from the computation of diluted net loss per share of common stock for the three and nine months
ended September 30, 2024 and 2023, as their effect was anti-dilutive (in thousands):
SCHEDULE OF COMPUTATION OF DILUTED
NET LOSS PER SHARE OF COMMON STOCK
| |
Three and nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 20,386 | | |
| 10,807 | |
Convertible Notes converted into common stock | |
| 16,106 | | |
| 3,087 | |
Stock options | |
| 2,516 | | |
| 510 | |
Preferred stock converted into common stock | |
| 31 | | |
| 12 | |
RSUs | |
| - | | |
| 1 | |
Total potential common shares excluded from computation | |
| 39,039 | | |
| 14,417 | |
15) | STANDBY
EQUITY PURCHASE AGREEMENT |
On
April 5, 2023, the Company entered into the ELOC with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $10.0
million of the Company’s common stock, subject to the terms and conditions contained in the appliable agreements. Such sales of
common stock by the Company, if any, are subject to certain limitations set forth in the purchase agreement, and may occur from time
to time, at the Company’s sole discretion, over a period of up to 24-months, commencing April 25, 2023, which was the date on which
each of the conditions to Lincoln Park’s purchase obligations set forth in the purchase agreement were initially satisfied. In
consideration of Lincoln Park’s entry into the purchase agreement, the Company issued to Lincoln Park approximately 74,000 shares
of common stock as commitment shares. The value of the commitment shares was recorded as a period expense and included in other expense,
net, in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2023.
In
April 2023, the Company filed a registration statement on Form S-1 to register the sale from time to time of up
to 2,930,237 shares of the Company’s common stock by Lincoln Park, including the approximately 74,000 commitment shares, which
was declared effective on April 24, 2023 (the “ELOC S-1”).
During
the three and nine months ended September 30, 2023, the Company issued and sold approximately 214,000 shares of common stock under the
ELOC, including the approximately 74,000 commitment shares, for gross proceeds of $0.3 million. No shares were sold under the ELOC
during the three or nine months ended September 30, 2024. As of September 30, 2024, there were approximately 2,716,000 shares remaining
to be sold under the ELOC that are registered for resale by Lincoln Park under the ELOC S-1.
16) | RECENT
ACCOUNTING PRONOUNCEMENTS |
No
new Accounting Standards Updates have been issued by the Financial Accounting Standards Board since January 1, 2024 that
would apply to the Company that are not disclosed in the 2023 10-K.
As
discussed in Note 5, on September 24, 2024, the Company entered into the September 2024 Transactions. On October 29, 2024, the Company
held its Annual Meeting, whereby the Company’s stockholders approved the September 2024 Transactions, and as a result, the following
occurred:
|
● |
Under
the Common Stock Private Placement, the Company issued approximately 1,402,000 shares of common stock and pre-funded warrants to
purchase 115,000 shares of common stock and received approximately $1.1 million in gross proceeds from the issuance of such securities.
The pre-funded warrants have an exercise price of $0.005 per share, are exercisable at any time and will not expire
until exercised in full. |
|
|
|
|
● |
Under
the Bridge Notes, approximately $3.0 million of the principal amount of the bridge notes plus all accrued and unpaid interest thereon,
plus such amount of interest that would have accrued on the principal amount through December 24, 2024, was automatically converted
at a conversion price of $0.50 into approximately 6,244,000 shares of the Company’s common stock and approximately $0.9 million
of the principal amount of the bridge notes plus all accrued and unpaid interest thereon, plus such amount of interest that would
have accrued on the principal amount through December 24, 2024, was automatically converted at a conversion price of $0.50 into pre-funded
warrants to purchase 1,764,000 shares of common stock. The pre-funded warrants have an exercise price of $0.005 per share, are exercisable at any time and will not expire until exercised in full. |
|
|
|
|
● |
Under
the Exchange Transactions, (i) the holders of the warrants exchanged approximately 19,902,000 warrants for approximately 9,951,000
shares of the Company’s common stock at an exchange ratio of one-half of a share of common stock for every one share of common
stock issuable upon exercise of the applicable warrant (rounded up to the nearest whole number), and (ii) the holders of the
convertible notes exchanged all their convertible notes for approximately 28,351,000 shares of the Company’s common stock at an exchange ratio
equal to (A) the sum expressed in U.S. dollars of (1) the principal amount of the applicable convertible note, plus (2) all accrued
and unpaid interest thereon through the date the applicable convertible note is exchanged plus (3) all interest that would have
accrued through, but not including, the maturity date of applicable convertible note if it was outstanding from the date such
convertible note is exchanged through its maturity date, divided by (B) $1.00
(rounded up to the nearest whole number). The Company issued approximately 38,302,000
shares of our common stock at the closing of the Exchange Transactions. |
In total, the Company issued
approximately 45.9 million shares of common stock and 1.9 million pre-funded warrants on October 29, 2024 pursuant to the September
24, 2024 Transactions and had 51.4 million shares of common stock issued and outstanding.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You
should read this discussion together with the unaudited interim condensed consolidated financial statements, related notes, and
other financial information included elsewhere in this Quarterly Report on Form 10-Q together with our audited consolidated
financial statements, related notes, and other information contained in our
Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities
and Exchange Commission (the “SEC”) on March 14, 2023, as amended by the Form 10-K/A filed with the SEC on March
18, 2024 (as amended, the “2023 10-K”). The following discussion contains or is
based on assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties, including
those discussed under “Risk Factors,” in this report and in Part I, Item
1A of the 2023 10-K and as described from time to time in our other filings with the SEC. These risks could cause our actual results
to differ materially from those anticipated in these forward-looking statements.
Overview
We
are a preclinical-stage cell therapy company. Our vision is to improve the lives of patients with difficult-to-treat diseases through
innovative, effective, and safe, but accessible cellular therapies, and our mission is to develop allogenic off-the-shelf cellular therapies,
leveraging induced pluripotent stem cell (“iPSC”)-derived mesenchymal stem cells (“iMSCs”) to target solid tumors.
Our
lead product ERNA-101 is allogenic IL-7 and IL-15-secreting iMSCs. ERNA-101 capitalizes on the intrinsic tumor-homing ability of MSCs
to slip through the tumor’s defenses and to deliver potent pro-inflammatory factors directly to the tumor microenvironment (“TME”),
limiting systemic exposure and potential toxicity while unleashing potent anti-cancer immune responses including enhancement of T-cell
anti-tumor activity. Our initial focus is to develop ERNA-101 in triple negative breast cancer and platinum-resistant, tp53-mutant ovarian
cancer. We collaborated with the University of Texas MD Anderson Cancer Center to investigate the ability of ERNA-101 to induce and modulate
antitumor immunity in ovarian cancer and breast cancer model. We are expecting to complete the Investigational New Drug (“IND”)
enabling studies and IND submission by 2026. We are also planning to investigate anti-inflammatory cytokine (e.g. IL-10)-secreting iMSCs
in inflammatory/auto-immune disorders like Rheumatoid arthritis. We are actively seeking strategic partnerships to co-develop or out-license
therapeutic assets and engage with potential collaborators to expand developmental opportunities.
Recent
Developments
Private
Placement
On
October 29, 2024, we closed a private placement in which we sold an aggregate of 1,401,994 shares of our common stock and pre-funded
warrants to purchase 115,000 shares of our common stock at a purchase price of $0.75 per share of common stock and $0.745 per pre-funded warrant. We received approximately $1.1 million in gross proceeds from the issuance of
such securities. For additional information regarding this private placement, see Note 5 to the accompanying condensed consolidated financial
statements.
Exchange
Transactions
Also
on October 29, 2024, in accordance with exchange agreements we entered into with the holders of certain of our warrants and convertible
notes, we issued an aggregate of 38,302,029 shares of our common stock in exchange for: (i) warrants to purchase an aggregate of approximately
4.4 million shares of our common stock that we issued in December 2022 with an exercise price of $1.43 per share; (ii) $8.7 million in
the aggregate principal amount of convertible notes that we issued in July 2023 and warrants to purchase an aggregate of approximately
6.1 million shares of our common stock that we issued in July 2023 with an exercise price of $1.43 per share; (iii) $9.2 million in the
aggregate principal amount of convertible notes that we issued in December 2023 and warrants to purchase an aggregate of approximately
9.6 million shares of our common stock that we issued in December 2023 with an exercise price of $1.43 per share.
The
holders of the warrants described in the paragraph above exchanged all their warrants for shares of our common stock at an exchange ratio
of 0.5 of a share of common stock for every one share of common stock issuable upon exercise of the applicable warrant (rounded up to
the nearest whole number), and the holders of the convertible notes described in the paragraph above exchanged all their convertible
notes for shares of our common stock at an exchange ratio equal to (A) the sum expressed in U.S. dollars of (1) the principal amount
of the applicable convertible note, plus (2) all accrued and unpaid interest thereon through the date the applicable convertible note
is exchanged plus (3) all interest that would have accrued through, but not including, the maturity date of applicable convertible note
if it was outstanding from the date such convertible note is exchanged through its maturity date, divided by (B) $1.00 (rounded up to
the nearest whole number).
For
additional information regarding the exchange transactions, see Note 5 to the accompanying condensed consolidated financial statements.
Conversion
of Bridge Notes
On
September 24, 2024, we closed a private placement in which we sold an aggregate principal amount of approximately $3.9 million of 12.0%
senior convertible notes (the “bridge notes”).
On
October 29, 2024, in accordance with the terms of the bridge notes, approximately $3.0 million of the principal amount of the bridge
notes plus all accrued and unpaid interest thereon, plus such amount of interest that would have accrued on the principal amount through
December 24, 2024, was automatically converted at a conversion price of $0.50 into 6,244,237 shares of our common stock, and approximately
$0.9 million of the principal amount of the bridge notes plus all accrued and unpaid interest thereon, plus such amount of interest that
would have accrued on the principal amount through December 24, 2024, was automatically converted at a conversion price of $0.50 into
pre-funded warrants to purchase 1,764,000 shares of our common stock.
For
additional information regarding the private placement and conversion of the bridge notes, see Note 5 to the accompanying condensed consolidated
financial statements.
In total, the Company issued
approximately 45.9 million shares of common stock and 1.9 million pre-funded warrants on October 29, 2024 pursuant to the private placement,
the exchange transactions and the conversion of the bridge notes discussed above and had 51.4 million shares of common stock issued and
outstanding.
Agreements
with Factor Bioscience
License
Agreement
On
September 24, 2024, we entered into the Exclusive License and Collaboration Agreement (“the Factor L&C Agreement”) with
Factor Bioscience Limited (“Factor Limited”). The Factor L&C Agreement terminated the Amended and Restated Factor License
Agreement (the “A&R Factor License Agreement”) entered into on November 14, 2023 as well as an exclusive license agreement
we acquired from Dilos Bio (formerly known as Exacis Biotherapeutics Inc. (“Exacis”)) under an asset purchase agreement in
April 2023.
Under
the Factor L&C Agreement, we have obtained an exclusive license in the fields of cancer, autoimmune disorders, and rare diseases
with respect to certain licensed technology and we have the right to develop the licensed technology directly or enter into co-development
agreements with partners who can help bring such technology to market. The Factor L&C Agreement also provides for certain services
and materials to be provided by Factor to facilitate our development of the licensed technology and to enable us to scale up production
at third party facilities.
The
initial term of the Factor L&C Agreement is one year after the effective date, and it automatically renews yearly thereafter. We
may terminate the Factor L&C Agreement for any reason upon 90 days’ written notice to Factor, and the parties otherwise have
customary termination rights, including in connection with certain uncured material breaches and specified bankruptcy events.
Pursuant
to the Factor L&C Agreement, we will pay Factor $0.2 million per month for the first twelve months, $0.1 million per month for the
first nine months toward patent costs, certain milestone payments, royalty payments on net sales of commercialized products and sublicensing
fee payments.
Lineage
Assignment Agreement
On
September 24, 2024, we entered into an agreement with Factor Bioscience Inc. (“Factor”) whereby we assigned the exclusive
option and license agreement (the “Lineage Agreement”) to Factor (the “Lineage Assignment Agreement”). Our rights
and obligations under the agreement are now Factor’s responsibility.
Payments
related to the Lineage Agreement will now be subject to the Lineage Assignment Agreement, which provides for Factor paying us thirty
percent (30%) of all amounts it actually receives from Lineage in the event that Lineage exercises its Option Right. Upon receipt of
payment for the customization activities set forth in the Lineage Agreement, Factor will pay the Company twenty percent (20%) of all
amounts Factor receives from Lineage.
Termination
of Sublease
In
October 2022, we entered into a sublease for office and laboratory space in Somerville, Massachusetts. In connection with entering into
the sublease, we delivered a security deposit in the form of a letter of credit in the amount of $4.1 million. The letter of credit was
collateralized with $4.1 million of cash deposited in a restricted account.
On
August 5, 2024, the sublessor drew down on the letter of credit for the full $4.1 million to cover the approximately $4.0 million of
past due rent payments for February 2024 through August 2024, plus interest and penalties.
On
August 9, 2024, we and the sublessor entered into a sublease termination agreement pursuant to which the parties agreed to terminate
the sublease effective August 31, 2024. Pursuant to the sublease termination agreement, we agreed to surrender and vacate the premises,
all of our right, title and interest in all furniture, fixtures and laboratory equipment at the premises will become the property of
the sublessor, and both parties will be released of their obligations under the sublease. As a result of the sublease termination, we
recognized a gain on lease termination of approximately $1.6 million for the three and nine months ended September 30, 2024, and we expect
to save approximately $72 million in base rental payments, parking, operating expenses, taxes and utilities that we would have paid over
the remaining lease term.
Nasdaq
Matters
On March 19, 2024, we received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq
Stock Market LLC (“Nasdaq”) stating that we were not in compliance with the Nasdaq listing rule 5550(b)(1) (the “Minimum
Stockholders’ Equity Rule”) because we reported stockholders’ equity of less than $2.5 million as of December 31, 2023.
The notice had no immediate effect on our Nasdaq listing. In May 2024, we submitted a plan to Nasdaq advising
of actions we have taken or will take to regain compliance with the Minimum Stockholders’ Equity Rule. Nasdaq accepted our plan
and granted us a 180-day extension, or through September 16, 2024, to regain compliance with the Minimum Stockholders’ Equity Rule.
On September 17, 2024, we received a notice from the Staff stating that the Staff has determined that we
did not meet the terms of the extension to confirm or demonstrate compliance with the Minimum Stockholders’ Equity Rule by September
16, 2024, and, as a result, unless we request an appeal of such determination by September 24, 2024, trading of our common stock will
be suspended at the opening of business on September 26, 2024, and a Form 25-NSE will be filed with the SEC, which will remove our securities
from listing and registration on Nasdaq. On September 24, 2024,we submitted a timely request for a hearing with the Nasdaq’s Hearings
Panel to appeal the Staff’s determination. The request stayed the suspension of trading of our common stock and the filing of the
Form 25-NSE pending the Hearing Panel’s decision. The hearing was scheduled for November 12, 2024.
After
giving effect to (i) the reclassification of the debt represented by the convertible notes to equity as a result of the exchange of the
convertible notes that occurred on October 29, 2024, (ii) the receipt of net proceeds we received in the October 2024 private placement
of our common stock and pre-funded warrants to purchase shares of our common stock, and (iii) the reclassification of the debt represented
by the bridge notes to equity as a result of the conversion of the bridge notes into shares of our common stock or pre-funded warrants
to purchase shares of our common stock, and after taking into account the savings resulting from the termination of our former sublease,
our stockholders’ equity exceeds $2.5 million on a proforma basis as of September 30, 2024, which we communicated in our pre-hearing
submission of materials to the Hearing Panel on October 23, 2024. Additionally, due to issuing over 45.9 million shares of common stock
from the transactions described above and having a total of 51.4 million shares of common stock issued and outstanding as of October
29, 2024, the market value of our listed securities has exceeded the minimum of $35 million under Nasdaq Listing Rule 5550(b)(2) for
ten consecutive trading days. As a result, the Staff informed the Company that is has regained compliance with Nasdaq Listing Rule 5550(b)
and our stock will continue to be listed and traded on Nasdaq. Accordingly, the Hearing Panel cancelled the November 12, 2024 hearing.
Basis
of Presentation
Revenue
In
February 2023, we entered into the Lineage Agreement with Lineage, under which we granted Lineage an option to obtain an exclusive sublicense
to certain of our technology for preclinical, clinical and commercial purposes in exchange for a non-refundable up-front payment to us
of $0.3 million. In August 2023, Lineage requested that we begin developing certain induced pluripotent stem cell lines in exchange for
a cell line customization fee. Lineage paid us $0.4 million towards the customization fee, which we were recognizing ratably over the
customization period. On September 24, 2024, we entered into the Lineage Assignment Agreement with Factor Inc. to assign all our rights
and obligations under that the Lineage Agreement to Factor Inc. Payments to us related to the Lineage Agreement will now be subject to
the Lineage Assignment Agreement, which provides for Factor Inc. paying the us thirty percent (30%) of all amounts it receives
from Lineage in the event that Lineage obtains a sublicense from Factor Inc. Upon receipt of future payments for the customization activities
set forth in the Lineage Agreement, Factor Inc. will pay the us twenty percent (20%) of all amounts Factor Inc. receives from Lineage.
Because we have no further obligations under the agreement with Lineage, we have fully recognized as revenue amounts previously recorded
in deferred revenue of approximately $0.5 million for the three and nine months ended September 30, 2024. For additional information,
see Note 4 to the accompanying condensed consolidated financial statements. We have no other revenue generating contracts at this time.
Cost
of Revenues
We
recognize direct labor and supplies associated with generating our revenue as cost of revenues. As provided for in the A&R Factor
License Agreement discussed in Note 10 to the accompanying condensed consolidated financial statements, we were obligated to pay Factor
Limited 20% of any amounts we receive from a customer that was related to the licensed technology under the A&R Factor License Agreement,
which we also recognize as a cost of revenue.
Research
and Development Expenses
We
expense our research and development costs as incurred. Our research and development expenses consist of costs incurred for company-sponsored
research and development activities, as well as support for selected investigator-sponsored research. Upfront payments and milestone
payments we make for the in-licensing of technology are expensed as research and development in the period in which they are incurred
if the technology is not expected to have any alternative future uses other than the specific research and development project for which
it was intended.
The
major components of research and development costs include salaries and employee benefits, stock-based compensation expense, supplies
and materials, preclinical study costs, expensed licensed technology, consulting, scientific advisors and other third-party costs, and
allocations of various overhead costs related to our research and development efforts.
We
have contracted with third parties to perform various studies. The financial terms of these agreements vary from contract to contract
and may result in uneven payment flows. We accrue for third party expenses based on estimates of the services received and efforts expended
during the reporting period. If the actual timing of the performance of the services or the level of effort varies from the estimate,
the accrual is adjusted accordingly. The expenses for some third-party services may be recognized on a straight-line basis if the expected
costs are expected to be incurred ratably during the period. Payments under the contracts depend on factors such as the achievement of
certain events or milestones, the successful enrollment of patients, the allocation of responsibilities among the parties to the agreement,
and the completion of portions of the clinical study or trial or similar conditions.
General
and Administrative Expenses
Our
general and administrative expenses consist primarily of salaries, benefits and other costs, including equity-based compensation, for
our executive and administrative personnel, legal and other professional fees, travel, insurance, and other corporate costs.
Results
of Operations
Comparison
of the Three and Nine Months Ended September 30, 2024 and 2023
| |
Three months ended
September 30, | | |
| | |
Nine months ended
September 30, | | |
| |
| |
2024 | | |
2023 | | |
Change | | |
2024 | | |
2023 | | |
Change | |
Revenue | |
$ | 487 | | |
$ | 51 | | |
$ | 436 | | |
$ | 581 | | |
$ | 51 | | |
$ | 530 | |
Cost of revenues | |
| (60 | ) | |
| 120 | | |
| (180 | ) | |
| 96 | | |
| 170 | | |
| (74 | ) |
Gross income (loss) | |
| 547 | | |
| (69 | ) | |
| 616 | | |
| 485 | | |
| (119 | ) | |
| 604 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 1,001 | | |
| 1,387 | | |
| (386 | ) | |
| 3,446 | | |
| 4,560 | | |
| (1,114 | ) |
General and administrative | |
| 3,381 | | |
| 4,049 | | |
| (668 | ) | |
| 11,592 | | |
| 10,231 | | |
| 1,361 | |
Gain on lease termination | |
| (1,576 | ) | |
| - | | |
| (1,576 | ) | |
| (1,576 | ) | |
| - | | |
| (1,576 | ) |
Acquisition of Exacis in-process research and development | |
| - | | |
| - | | |
| - | | |
| - | | |
| 460 | | |
| (460 | ) |
Total operating expenses | |
| 2,806 | | |
| 5,436 | | |
| (2,630 | ) | |
| 13,462 | | |
| 15,251 | | |
| (1,789 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,259 | ) | |
| (5,505 | ) | |
| 3,246 | | |
| (12,977 | ) | |
| (15,370 | ) | |
| 2,393 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Other (expense) income, net: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Loss on extinguishment of debt | |
| (22,440 | ) | |
| - | | |
| (22,440 | ) | |
| (22,440 | ) | |
| - | | |
| (22,440 | ) |
Incremental fair value of bridge note derivative liability | |
| (1,038 | ) | |
| - | | |
| (1,038 | ) | |
| (1,038 | ) | |
| - | | |
| (1,038 | ) |
Change in fair value of warrant liabilities | |
| 831 | | |
| 20 | | |
| 811 | | |
| 897 | | |
| 166 | | |
| 731 | |
Change in fair value of contingent consideration | |
| - | | |
| - | | |
| - | | |
| 66 | | |
| 118 | | |
| (52 | ) |
Loss on non-controlling investment | |
| - | | |
| - | | |
| - | | |
| - | | |
| (59 | ) | |
| 59 | |
Interest expense, net | |
| (1,686 | ) | |
| (113 | ) | |
| (1,573 | ) | |
| (3,269 | ) | |
| (88 | ) | |
| (3,181 | ) |
Other expense, net | |
| - | | |
| (1 | ) | |
| 1 | | |
| - | | |
| (281 | ) | |
| 281 | |
Total other expense, net | |
| (24,333 | ) | |
| (94 | ) | |
| (24,239 | ) | |
| (25,784 | ) | |
| (144 | ) | |
| (25,640 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Loss before income taxes | |
| (26,592 | ) | |
| (5,599 | ) | |
| (20,993 | ) | |
| (38,761 | ) | |
| (15,514 | ) | |
| (23,247 | ) |
(Provision) benefit for income taxes | |
| (11 | ) | |
| 8 | | |
| (19 | ) | |
| (18 | ) | |
| (1 | ) | |
| (17 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (26,603 | ) | |
$ | (5,591 | ) | |
$ | (21,012 | ) | |
$ | (38,779 | ) | |
$ | (15,515 | ) | |
$ | (23,264 | ) |
Revenue
During
the three and nine months ended September 30, 2024, we fully accelerated the recognition of approximately $0.5 million of deferred revenue
related to nonrefundable payments we received from Lineage due to the Lineage Assignment Agreement we entered into on September 24, 2024
with Factor Inc. discussed earlier. For the three and nine months ended September 30, 2023, the revenue we recognized was related to
customization activities performed for Lineage.
Cost
of Revenue
During
the nine months ended September 30, 2024, our cost of revenues included direct labor and materials to perform the customization cell
line activities for Lineage. During the three months ended September 30, 2024, we recognized a credit for amounts previously accrued
related to customization cell line activities that were no longer due as a result of entering into the Lineage Assignment Agreement with
Factor Inc. During the three and nine months ended September 30, 2023, we recognized direct labor and materials related to the customization
activities as well as the 20% license fee due to Factor Limited related to upfront payments received from Lineage under the customer
agreement.
Research
and Development Expenses
| |
Three months ended
September 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | |
| | |
| |
Professional fees | |
$ | 64 | | |
$ | 225 | | |
$ | (161 | ) |
Payroll-related | |
| 58 | | |
| 134 | | |
| (76 | ) |
MSA/license fees | |
| 767 | | |
| 813 | | |
| (46 | ) |
Stock-based compensation | |
| 13 | | |
| 57 | | |
| (44 | ) |
Other expenses, net | |
| 99 | | |
| 158 | | |
| (59 | ) |
Total research and development expenses | |
$ | 1,001 | | |
$ | 1,387 | | |
$ | (386 | ) |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | |
| | |
| |
Professional fees | |
$ | 152 | | |
$ | 675 | | |
$ | (523 | ) |
Stock-based compensation | |
| 74 | | |
| 177 | | |
| (103 | ) |
Payroll-related | |
| 444 | | |
| 504 | | |
| (60 | ) |
MSA/license expense | |
| 2,392 | | |
| 2,438 | | |
| (46 | ) |
Other expenses, net | |
| 384 | | |
| 766 | | |
| (382 | ) |
Total research and development expenses | |
$ | 3,446 | | |
$ | 4,560 | | |
$ | (1,114 | ) |
Total
research and development expenses decreased by approximately $0.4 million and $1.1 million for the three and nine months ended September
30, 2024, respectively, compared to the three months ended September 30, 2023, primarily due to decreased professional fees due
to a reduction in consultant services, payroll-related expenses and stock-based compensation from a reduction in headcount, MSA/license
fees as a result of the new L&C Agreement and other expenses related to closing down a clinical trial we ended in 2022.
General
and Administrative Expenses
| |
Three months ended
September 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | |
| | |
| |
Professional fees | |
$ | 1,125 | | |
$ | 1,726 | | |
$ | (601 | ) |
Occupancy expense | |
| 1,267 | | |
| 1,563 | | |
| (296 | ) |
Insurance | |
| 93 | | |
| 209 | | |
| (116 | ) |
Stock-based compensation | |
| 392 | | |
| 117 | | |
| 275 | |
Payroll-related | |
| 367 | | |
| 254 | | |
| 113 | |
Other expenses, net | |
| 137 | | |
| 180 | | |
| (43 | ) |
Total general and administrative expenses | |
$ | 3,381 | | |
$ | 4,049 | | |
$ | (668 | ) |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | |
| | |
| |
Occupancy expense | |
$ | 5,068 | | |
$ | 1,606 | | |
$ | 3,462 | |
Stock-based compensation | |
| 1,036 | | |
| 900 | | |
| 136 | |
Professional fees | |
| 3,409 | | |
| 5,054 | | |
| (1,645 | ) |
Insurance | |
| 405 | | |
| 936 | | |
| (531 | ) |
Payroll-related | |
| 1,234 | | |
| 1,312 | | |
| (78 | ) |
Other expenses, net | |
| 440 | | |
| 423 | | |
| 17 | |
Total general and administrative expenses | |
$ | 11,592 | | |
$ | 10,231 | | |
$ | 1,361 | |
Our
general and administrative expenses decreased by approximately $0.7 million for the three months ended September 30, 2024 compared
to the three months ended September 30, 2023 primarily due to decreases in professional fees related to legal services and consultants,
rent expense due to the termination of our Somverville sublease effective August 31, 2024 and a reduction in insurance premiums. These
decreases were offset by increases in payroll-related expense and stock-based compensation due to an increase in headcount as well as
an inducement stock option grant given to our chief executive officer in January 2024 compared to the three months ended September
30, 2023.
Our
general and administrative expenses increased by approximately $1.4 million for the nine months ended September 30, 2024 compared
to the nine months ended September 30, 2023 primarily due to increased occupancy expense related to the Somerville sublease that we began
to incur in July 2023 as well as increased stock-based compensation due to the chief executive officer’s inducement stock option
grant. The increase in occupancy expense was partially offset by decreases in professional fees related to legal services and consultants,
insurance expense due to lower premiums and payroll-related expenses resulting from a decrease severance expense during the nine months
ended September 20, 2024 compared to the nine months ended September 30, 2023.
Gain
on Lease Termination
On
August 9, 2024, we and the sublessor of our Somerville sublease entered into a sublease termination agreement effective August 31, 2024.
Pursuant to the sublease termination agreement, we agreed to surrender and vacate the premises, all of our right, title and interest
in all furniture, fixtures and laboratory equipment at the premises will become the property of the sublessor, and both parties will
be released of their obligations under the sublease. As a result of the sublease termination, we recognized a gain on lease termination
of approximately $1.6 million for the three and nine months ended September 30, 2024 in the accompanying condensed consolidated statement
of operations. There was no similar transaction during the three or nine months ended September 30, 2023.
Acquisition
of Exacis In-Process Research and Development
In
April 2023, we acquired from Exacis substantially all of its intellectual property assets, including all of its right, title and interest
in and to the Purchased License. The Purchased License was determined to be an in-process research and development (“IPR&D”)
asset that has no alternative future use and no separate economic value from its original intended purpose, which is expensed in the
period the cost is incurred. As a result, we expensed the fair value of the Purchased License of approximately $0.5 million during the
three and nine months ended September 30, 2023. For additional information, see Note 3 to the accompanying consolidated financial statements
included in this report. There was no similar transaction during the three or nine months ended September 30, 2024.
Loss
on Extinguishment of Debt
We
recognized a $22.4 million loss on extinguishment of debt for the three and nine months ended September 30, 2024 related to the Exchange
Agreements and common stock private placement entered into on September 24, 2024. There was no similar transaction during the three or
nine months ended September 30, 2023. See Note 5 to the accompanying condensed consolidated financial statements for more information
on the Exchange Transaction.
Fair Value Adjustments to Bridge Notes Derivative Liability
We
recognized expense of $1.6 million related to the initial measurement at September 24, 2024 of the incremental fair value of the
bridge notes derivative liability over the carrying value due to bifurcation of the conversion feature from the bridge notes. This was offset by a $0.6 million credit for the change in fair value of
the bridge notes derivative liability due to remeasuring the liability as of September 30, 2024. There
was no similar transaction during the three or nine months ended September 30, 2023. See Note 5 to the accompanying condensed
consolidated financial statements for more information on the bridge notes.
Change
in Fair Value of Warrant Liabilities
We
recognized credits of less than $0.8 million and $0.9 million for the three and nine months ended September 30, 2024 for the change in
the fair value of warrant liabilities, which includes certain warrants that were reclassified to a liability
on September 24, 2024. The credits were due to a decrease in the market price of our common stock as of September 30, 2024.
For
the three and nine months ended September 30, 2023, we recognized credits of less than $0.1 million and $0.2 million, respectively,
for the change in the fair value of warrant liabilities due to a decrease in the market price of our common stock as of September
30, 2023. See Note 5 to the accompanying condensed consolidated financial statements for more information on the reclassification of
the warrants.
Change
in Fair Value of Contingent Consideration
On
the closing date of the acquisition of assets from Exacis in April 2023, we recognized a contingent consideration liability of $0.2 million
for future payments that may be payable to Exacis, which was included as part of the $0.5 million fair value of the Purchased License
asset and expensed as IPR&D for the nine months ended September 30, 2023. This contingent consideration liability is remeasured at
each period end, and any change in the fair value of the contingent liability is recognized in the statement of operations. As of September
30, 2023, we remeasured the contingent liability and recognized a credit of $0.1 million for the nine months ended September 30, 2023
due to the decrease in the fair value of the contingent consideration liability. As of September 30, 2024, we remeasured the contingent
liability and recognized a credit of $0.1 million for the nine months ended September 30, 2024 due to the decrease in the fair value
of the contingent consideration liability. There were no amounts recognized for either of the three months ended September 30, 2023 or
2024.
Loss
on Non-Controlling Investment
We
account for our 25% non-controlling investment in NoveCite, Inc. (“NoveCite”) under the equity method. We have not guaranteed
any obligations of NoveCite, nor are we otherwise committed to providing further financial support for NoveCite. Therefore, we only record
25% of NoveCite’s losses up to our investment carrying amount. As a result, we did not recognize additional losses related to NoveCite
for the three or nine months ended September 30, 2024 or the three months ended September 30, 2023. We recognized a loss of approximately
$0.1 million for the nine months ended September 30, 2023.
Interest
Expense, net
We
recognized an increase in interest expense for the three and nine months ended September 30, 2024 of approximately $1.6 million and $3.2
million, respectively, primarily due to interest expense and amortization of debt issuance costs associated with the 2023 convertible
note financings and bridge notes when compared to the three and nine months ended September 30, 2023. As a result of the closing of the
Exchange Transactions on October 29, 2024, we expect our future interest expense to be significantly decreased.
Other
Expense, net
During
the nine months ended September 30, 2023, we recognized $0.3 million of other expense, all of which related to the value of the
commitment shares issued to Lincoln Park Capital Fund, LLC (“Lincoln Park”) under a standby equity purchase agreement
(the “ELOC”) we entered into in April 2023 as well as other associated fees. We did not recognize any such expense
during the three or nine months ended September 30, 2024 and a de minimus amount of other expense during the three months ended
September 30, 2023.
Provision
for Income Taxes
During
2024, we expect to incur state income tax liabilities related to our operations. We have established a full valuation allowance for all
deferred tax assets, including our net operating loss carryforwards, since we could not conclude that we were more likely than not able
to generate future taxable income to realize these assets. The effective tax rate differs from the statutory tax rate due primarily to
our full valuation allowance.
Liquidity
and Capital Resources
As
of September 30, 2024, we had cash of approximately $4.3 million, of which approximately $3.9 million was from proceeds from the
bridge notes received on September 24, 2024, and we had an accumulated deficit of approximately $225.8 million. We have to date
incurred operating losses, and we expect these losses to continue in the future. For the three and nine months ended September 30,
2024, we incurred a net loss of $26.6 million and $38.8 million, respectively. For the nine months ended September 30, 2024, we used
$12.3 million of cash in operating activities.
On
October 29, 2024, we also received approximately $1.1 million upon the closing of the common stock private placement. Other than the
proceeds raised under the bridge notes and the common stock private placement, our sole source of liquidity is through sales of our common
stock under the ELOC, pursuant to which Lincoln Park committed to purchase up to $10.0 million of our common stock. Such sales of common
stock by us, if any, are subject to certain conditions and limitations set forth in the ELOC, including a condition that we may not direct
Lincoln Park to purchase any shares of common stock under the ELOC if such purchase would result in Lincoln Park beneficially owning
more than 4.99% of our issued and outstanding shares of common stock. Sales under the ELOC may occur from time to time, at our sole discretion,
through April 2025. To date, we have issued and sold approximately 214,000 shares of our common stock to Lincoln Park, including approximately 74,000 commitment shares, and have received approximately $0.3 million in gross proceeds from such sales. We sold no shares
under the ELOC during the nine months ended September 30, 2024.
Based
on our current financial condition and forecasts of available cash, we will not have sufficient capital to fund our operations for the
12 months following the issuance date of the accompanying condensed consolidated financial statements. We can provide no assurance that
we will be able to obtain additional capital when needed, on favorable terms, or at all. If we cannot raise capital when needed, on favorable
terms or at all, we will need to reevaluate our planned operations and may need to reduce expenses, file for bankruptcy, reorganize,
merge with another entity, or cease operations. If we become unable to continue as a going concern, we may have to liquidate our assets,
and might realize significantly less than the values at which they are carried on our financial statements, and stockholders may lose
all or part of their investment in our common stock. See the risk factor in Item 1A of Part II of our 2023 10-K titled, “We will require substantial additional capital to fund our operations and
execute our business strategy, and we may not be able to raise adequate capital on a timely basis, on favorable terms, or at all.”
Historically,
the cash used to fund our operations has come from a variety of sources and predominantly from sales of shares of our common stock and
of convertible notes. We will continue to evaluate and plan to raise additional funds to support our working capital needs through public
or private equity offerings, debt financings, strategic partnerships, out-licensing our intellectual property or other means. There can
be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to us and our
stockholders. Our ability to raise capital through sales of our common stock will depend on a variety of factors including, among others,
market conditions, the trading price and volume of our common stock, and investor sentiment. In addition, macroeconomic factors and volatility
in the financial market, which may be exacerbated in the short term by concerns over inflation, interest rates, impacts of the wars in
Ukraine and the Middle East, strained relations between the U.S. and several other countries, and social and political discord and unrest
in the U.S., among other things, may make equity or debt financings more difficult, more costly or more dilutive to our stockholders.
In
addition, equity or debt financings may have a dilutive effect on the holdings of our existing stockholders, and debt financings may
subject us to restrictive covenants, operational restrictions and security interests in our assets. If we raise capital through collaborative
arrangements, we may be required to relinquish some rights to our technologies or grant sublicenses on terms that are not favorable to
us.
We
prepared the accompanying condensed consolidated financial statements on a going concern basis, which assumes that we will realize our
assets and satisfy our liabilities in the normal course of business. As discussed above, there is substantial doubt about our ability
to continue as a going concern because we do not have sufficient cash to satisfy our working capital needs and other liquidity requirements
over at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements. The accompanying
condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability
and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty
of our ability to remain a going concern.
In
addition, while we are not presently pursuing product development, we may do so in the future. Developing product candidates, conducting
clinical trials and commercializing products requires substantial capital, and we would need to raise substantial additional funds if
we were to pursue the development of one or more product candidates.
Cash
Flows
Cash
flows from operating, investing and financing activities, as reflected in the accompanying condensed consolidated statements of cash
flows, are summarized as follows:
| |
For the nine months ended September 30, | | |
| |
(in thousands) | |
2024 | | |
2023 | | |
Change | |
Cash (used in) provided by: | |
| | | |
| | | |
| | |
Operating activities | |
$ | (12,291 | ) | |
$ | (15,747 | ) | |
$ | 3,456 | |
Investing activities | |
| (365 | ) | |
| - | | |
| (365 | ) |
Financing activities | |
| 5,250 | | |
| 8,852 | | |
| (3,602 | ) |
Net decrease in cash and cash equivalents | |
$ | (7,406 | ) | |
$ | (6,895 | ) | |
$ | (511 | ) |
Net
Cash Used in Operating Activities
There
was a decrease of approximately $3.5 million in cash used in operating activities for the nine months ended September 30, 2024 compared
to the same period in 2023. This change was due to a decrease in cash used in operating assets and liabilities of $2.0 million primarily
related to a reduction in amounts due for the buildout costs of the Somerville facility and a $1.4 million decrease in net loss, after
giving effect to adjustments made for non-cash transactions, for the nine months ended September 30, 2024 compared to the same period
in 2023.
Net
Cash Used in Investing Activities
We
used approximately $0.3 million to pay for the purchases of property and equipment during the nine months ended September 30, 2024. There
were no investing activities during the nine months ended September 30, 2023.
Net
Cash Provided by Financing Activities
Net
cash provided by financing activities for the nine months ended September 30, 2024 includes approximately $5.3 million of gross proceeds
received from the convertible note financings that occurred in January 2024 and September 2024. Net cash provided by financing activities
for the nine months ended September 30, 2023 includes approximately $8.7 million of gross proceeds from convertible note financings and
$0.3 million of proceeds received from selling approximately 214,000 shares to Lincoln Park under the ELOC. The Company did not sell
any shares under the ELOC during the nine months ended September 30, 2024.
Critical
Accounting Estimates
There
were no significant changes in our critical accounting estimates during the three months ended September 30, 2024 from those described
in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of the 2023 10-K.
Recent
Accounting Pronouncements
No
new Accounting Standards Updates have been issued by the Financial Accounting Standards Board since
January 1, 2024 that would apply to us that are not disclosed in the 2023 10-K.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Under
the rules and regulations of the SEC, as a smaller reporting company we are not required to provide the information otherwise required
by this item.
Item
4. Controls and Procedures.
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) promulgated under the Exchange
Act, designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated
and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to
allow timely decisions regarding required disclosures.
In
designing and evaluating the disclosure controls and procedures, we recognized that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving the desired control objectives, and we were required to apply our judgment
in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as of the end of the
period covered by this Quarterly Report on Form 10-Q under the supervision, and with the participation, of our management, including
our President and Chief Executive Officer (who serves as our principal executive officer) and our Senior Vice President of Finance (who
serves as our principal financial officer) of the effectiveness of the design and operation of our disclosure controls and procedures.
Based
on that evaluation, our Chief Executive Officer and Senior Vice President of Finance concluded that our disclosure controls and procedures
were not effective as of the end of the period covered by this Quarterly Report on Form 10-Q in providing reasonable assurance of achieving
the desired control objectives due primarily to the material weakness discussed below.
Management’s
Plan for Remediation of Material Weakness in Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over
financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted accounting principles.
We
were unable to timely file our Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2022 with the SEC due to identifying errors in our financial statements reported in our Annual Report on Form 10-K for the
years ended December 31, 2021 and 2020 during our preparation of the financial statements for the quarter ended March 31, 2022. Management
concluded that the errors were the result of accounting personnel’s lack of technical proficiency in complex matters. On June 30,
2022, we filed an amendment to our Annual Report on Form 10-K for the years ended December 31, 2021 and 2020 to correct the errors in
our financial statements for the years ended December 31, 2021 and 2020 and for the quarters ended June 30, 2020, September 30, 2020,
March 31, 2021, June 30, 2021 and September 30, 2021.
Management
has implemented measures designed to ensure that the deficiencies contributing to the ineffectiveness of our internal control over financial
reporting are remediated, such that the internal controls are designed, implemented and operating effectively. The remediation actions
to date include:
|
● |
enhancing
the business process controls related to reviews over technical, complex, and non-recurring transactions; |
|
● |
providing
additional training to accounting personnel; and |
|
● |
using
an external accounting advisor to review management’s conclusions on technical, complex and non-recurring matters. |
The
material weakness cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time and
management has concluded, through testing, that these controls are operating effectively. As of September 30, 2024, we continue to season
and enhance such controls to ensure that they will continue to operate effectively for a sufficient period of time before management
can make conclusions on the operating effectiveness.
We
are committed to developing a strong internal control environment, and we believe the remediation efforts that we have implemented and
will implement will result in significant improvements in our control environment. Our management will continue to monitor and evaluate
the relevance of our risk-based approach and the effectiveness of our internal controls and procedures over financial reporting on an
ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary.
Changes
in Internal Control over Financial Reporting
Except
for the actions intended to remediate the material weakness as described above, there was no change in our internal control over financial
reporting during the most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
PART
II — OTHER INFORMATION
Item
1. Legal Proceedings.
The
information set forth under “Note 11—Commitments and Contingencies—Legal Matters” to the accompanying condensed
consolidated financial statements included in this Quarterly Report on Form 10-Q is incorporated in this Item 1 by reference.
From
time to time, we may become involved in legal proceedings arising in the ordinary course of business. Except as described above, are not party to any material legal proceedings.
Item
1A. Risk Factors.
An
investment in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in
our 2023 10-K, in addition to other information in this report, when evaluating our business and before deciding whether to purchase,
hold or sell shares of our common stock. Each of these risks and uncertainties, as well as additional risks and uncertainties not presently
known to us or that we currently consider immaterial, could harm our business, financial condition, results of operations and/or growth
prospects, as well as adversely affect the market price of our common stock, in which case you may lose all or part of your investment.
There have been no material changes to the risk factors described in the
2023 10-K.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
The
securities issued in connection with the closing of each of the September 2024 Transactions were exempt from the registration requirements
of the Securities Act of 1933, as amended (the “Securities Act”), under Section 3(a)(9) of the Securities Act, Section 4(a)(2)
of the Securities Act and/or Rule 506 of Regulation D of the Securities Act. Each of the investors in the common stock private placement
and the bridge notes represented to the Company that it is an accredited investor within the meaning of Rule 501(a) of Regulation D and
that it is acquiring the securities for investment only and not with a view towards, or for resale in connection with, the public sale
or distribution thereof. Each party to an Exchange Agreement represented to the Company that it has not paid or given, and will not pay
or give, to any person, any commission or other remuneration, directly or indirectly, for soliciting the exchange of securities thereunder.
None of the securities offered in the September 2024 Transactions were offered through any general solicitation by the Company or its
representatives. This report is not an offer to sell or a solicitation of an offer to buy any of the securities described herein.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
Applicable.
Item
5. Other Information.
(a)
None.
(b)
None.
(c)
During the quarter covered by this report, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act)
adopted or terminated any Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) or any non-Rule 10b5-1
trading arrangement (as defined in Item 408(c) of Regulation S-K).
Item
6. Exhibits
Exhibit |
|
Description |
|
Incorporated
By Reference |
10.1 |
|
Securities purchase agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the purchaser parties thereto |
|
Exhibit
10.1 to Form 8k filed on September 25, 2024 |
|
|
|
|
|
10.2 |
|
Form of pre-funded warrant issuable under the securities purchase agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the purchaser parties thereto |
|
Exhibit
10.2 to Form 8k filed on October 29, 2024 |
|
|
|
|
|
10.3 |
|
Form of exchange agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the parties thereto |
|
Exhibit
10.3 to Form 8k filed on September 25, 2024 |
|
|
|
|
|
10.4 |
|
Note purchase agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the purchaser parties thereto |
|
Exhibit
10.4 to Form 8k filed on September 25, 2024 |
|
|
|
|
|
10.5 |
|
Form of 12.0% senior convertible note issued under the note purchase agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the purchaser parties thereto |
|
Exhibit
10.5 to Form 8k filed on September 24, 2024 |
|
|
|
|
|
10.6 |
|
Form of pre-funded warrant issuable upon conversion of 12.0% senior convertible notes issued under the note purchase agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the purchaser parties thereto |
|
Exhibit
10.3 to Form 8k filed on October 29, 2024 |
|
|
|
|
|
10.7 |
|
Form of support agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the stockholder parties thereto |
|
Exhibit
10.7 to Form 8k filed on September 24, 2024 |
|
|
|
|
|
10.8 |
|
Form of lock-up agreement, dated as of September 24, 2024, between Eterna Therapeutics Inc. and the stockholder parties thereto |
|
Exhibit
10.8 to Form 8k filed on September 24, 2024 |
|
|
|
|
|
10.9 |
|
Registration Rights Agreement, dated October 29, 2024, between Eterna Therapeutics Inc. and the purchaser parties thereto |
|
Exhibit
10.1 to Form 8-K Filed on October 29, 2024 |
|
|
|
|
|
10.10 |
|
Exclusive License and Collaboration Agreement, effective as of September 9, 2024, with Factor Bioscience Limited |
|
Filed
herewith |
|
|
|
|
|
10.11 |
|
Sublease Termination Agreement, dated August 9, 2024, between Eterna Therapeutics Inc. and E.R. Squibb & Sons, L.L.C. |
|
Filed
herewith |
|
|
|
|
|
31.1 |
|
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
Filed
herewith |
|
|
|
|
|
31.2 |
|
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
Filed
herewith |
|
|
|
|
|
32.1 |
|
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
Furnished
herewith |
|
|
|
|
|
32.2 |
|
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
Furnished
herewith |
|
|
|
|
|
101 |
|
Inline XBRL Document Set for the financial statements and accompanying
notes in Part I, Item 1, of this Quarterly Report on Form 10-Q. |
|
Filed
herewith |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
ETERNA
THERAPEUTICS INC. |
|
|
|
Date:
November 12, 2024 |
By: |
/s/
Sanjeev Luther |
|
|
Sanjeev
Luther |
|
|
President
and Chief Executive Officer |
|
|
(Principal
Executive Officer) |
Date:
November 12, 2024 |
By: |
/s/
Sandra Gurrola |
|
|
Sandra
Gurrola |
|
|
Senior
Vice President of Finance |
|
|
(Principal
Financial Officer and Principal Accounting Officer) |
Exhibit
10.10
EXCLUSIVE
LICENSE AND COLLABORATION AGREEMENT
This
Exclusive License and Collaboration Agreement (“Agreement”) is made and entered into as of September 9, 2024 (“Effective
Date”), by and between Factor Bioscience Limited, a company organized and existing under the laws of Ireland (“Licensor”),
and Eterna Therapeutics Inc., a corporation organized and existing under the laws of the State of Delaware (“Licensee”).
Licensor and Licensee may each be referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
WHEREAS,
Licensor and Licensee previously entered into that certain Amended and Restated Exclusive License Agreement dated November 14, 2023 (the
“Original Agreement”), pursuant to which Licensor granted Licensee certain rights to certain licensed patents (as identified
in the Original Agreement);
WHEREAS,
the Parties desire to terminate the Original Agreement and replace it in its entirety with this Agreement;
WHEREAS,
the Parties desire to, as of the Effective Date, terminate the Exclusive License Agreement entered into as of November 4, 2020, by and
between Exacis Inc. (“Exacis”) and Licensor (“the Exacis Agreement”) and assigned to Licensee pursuant to that
certain Asset Purchase Agreement entered into as of April 26, 2023, by and among Licensee, Exacis, and certain stockholders of Exacis;
WHEREAS,
Licensor desires to collaborate with Licensee, and Licensee desires to collaborate with Licensor, in developing data to demonstrate the
efficacy of the Licensed Patents and Licensor Know-How to help identify promising candidates for drug development that can be developed
by Licensee directly or that can be sublicensed to third parties for further development;
WHEREAS,
Licensee desires to develop and commercialize Licensed Products (as defined herein), and Licensee desires to receive from Licensor certain
exclusive rights to the Licensed Patents and Licensor Know-How, in order that Licensee may develop and commercialize Licensed Products;
and
WHEREAS,
in furtherance of the foregoing, Licensor agrees to grant such rights to Licensee, and Licensee agrees to diligently proceed to develop
and make commercially available Licensed Products in accordance with this Agreement for commercial exploitation in the Field and in the
Territory (as defined herein);
NOW,
THEREFORE, in consideration of the foregoing and the mutual covenants and obligations undertaken herein, Licensor and Licensee agree
as follows:
Section
1
Definitions
1.1 | “Additional
Active Ingredient” means, with respect to a Combination Product, an active
therapeutic ingredient other than any of the Base Product Families. |
| |
1.2 | “Affiliate”
means, with respect to a Party, any Person that controls, is controlled by, or is under common
control with such Party. For the purposes of this definition, the word “control”
(including, with correlative meaning, the terms “controlled by” or “under
common control with”) means the actual power, either directly or indirectly through
one or more intermediaries, to direct or cause the direction of the management and policies
of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock
of such entity, or by contract or otherwise. For the purposes of this definition and this
Agreement, and for the avoidance of doubt, (a) Factor Bioscience Limited, Factor Bioscience
Pty Ltd, Factor Bioscience LLC, and Factor Bioscience Inc. (collectively, the “Factor
Bio Entities”) are each deemed not to be Affiliates of any of Eterna Therapeutics
Inc., Eterna Therapeutics LLC, and Novellus Therapeutics Limited (collectively, the “Eterna
Entities”), and (b) the Eterna Entities are each deemed not to be Affiliates
of any of the Factor Bio Entities. |
1.3 | “Applicable
Law” means all statutes, ordinances, regulations, rules or orders of any kind
whatsoever of any agency, bureau, branch, office, court, commission, authority, department,
ministry, official or other instrumentality of, or being vested with public authority under
any law of, any country, state or local authority or any political subdivision thereof, or
any association of countries that may be in effect from time to time and applicable to the
activities contemplated by this Agreement. |
| |
1.4 | “Base
Product Families” means products consisting of iMSCs made using the Technology
that are engineered to express (i) IL 7 and IL 15, (ii) IL 10, and/or (iii) IL 12, in each
case made pursuant to the SOPs in Exhibit B. |
| |
1.5 | “BLA”
means a Biologic License Application (as more fully described in U.S. 21 C.F.R. Part 601.20
or its successor regulation), as may be amended from time to time, or any analogous application
or submission with any Regulatory Authority outside of the United States. |
| |
1.6 | “Combination
Product” means a Licensed Product that includes or otherwise is administered
with one or more Additional Active Ingredients. |
| |
1.7 | “Commercially
Reasonable Efforts” means, with respect to the performance of activities hereunder
by or on behalf of Licensee, the carrying out of such activities using commercial and business
efforts and resources comparable to the efforts and resources that a life sciences company
engaged in the development, manufacture and commercialization of products similar to the
Licensed Products would typically devote to such activities. |
| |
1.8 | “Confidential
Information” means all nonpublic information disclosed by one Party to the
other during the negotiation of or under this Agreement in any manner, whether orally, visually,
electronically, in writing or in other tangible or intangible form. Notwithstanding any provision
of this Agreement to the contrary, and without limiting the foregoing (a) Licensor Know-How
and Know-How included in Party Improvements developed by Licensor will be deemed to be Licensor
Confidential Information and Licensee Know-How and Know-How included in Party Improvements
developed by Licensee will be deemed Licensee Confidential Information, unless such information
is subject to an exception described in Section 7.1 and (b) all Materials, together
with any derivatives and progeny thereof, will be deemed to be Licensor Confidential Information. |
| |
1.9 | “Control”
or “Controlled by” means, in the context of a license to or ownership
of Intellectual Property, the ability on the part of a Party to grant access to or a license
or sublicense of such Intellectual Property as provided for herein without violating the
terms of any agreement or other arrangement between such Party and any Third Party existing
at the time such Party would be required hereunder to grant such access or license or sublicense. |
| |
1.10 | “Cover”
means that the use, manufacture, sale, offer for sale, research, development, commercialization,
or importation of the subject matter in question (including a chemical or biologic agent,
or a process) by an unlicensed entity would infringe a granted Valid Claim (or, in the case
of a pending Valid Claim that has not yet been granted, would infringe such Valid Claim if
it were to be granted in its then-current form) of a Licensed Patent. |
1.11 | “Effective
Date” has the meaning set forth in the preamble of this Agreement. |
| |
1.12 | “Existing
License Agreements” means each agreement set forth in Exhibit E to this Agreement. |
| |
1.13 | “Exploit”
and “Exploitation” mean to make, have made, manufacture, use, sell,
have sold, offer for sale, commercialize, distribute, import and/or export. |
| |
1.14 | “FD&C
Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended. |
| |
1.15 | “Field”
means the prevention and/or treatment of: (i) rare diseases (meaning any disease which affects
less than 200,000 persons in the United States); (ii) auto-immune diseases; and (iii) cancer,
in each case (i)-(iii), in humans. |
| |
1.16 | “First
Commercial Sale” means with respect to a Licensed Product and a country, the
first sale for value of such Licensed Product in such country after Regulatory Approval for
the sale of such Licensed Product has been obtained in such country. |
| |
1.17 | “Improvement(s)”
means any invention, discovery, advancement, development, or creation which: (a) is invented,
developed, authored, created, or reduced to practice by or on behalf of Licensor, Licensee,
or Sublicensee(s) or jointly by Licensor and/or Licensee and/or Sublicensee(s), or any of
their respective Affiliates (or any of their respective personnel or agents, including any
employee, officer, advisor, or independent contractor employed or engaged by (or otherwise
having an obligation to assign inventions to) them) pursuant to this Agreement; and (b) is
an improvement, modification or enhancement to one or more of the Base Product Families or
Licensed Products. |
| |
1.18 | “Improvement
Patents” means the Patents claiming any of the Improvements, and any reissue,
divisional, continuation, continuation-in-part or reexamination certificate thereof. |
| |
1.19 | “IND”
means an Investigational New Drug Application (as defined in the FD&C Act) with respect
to a product, or equivalent application or submission for approval to conduct human clinical
investigations filed with or submitted to a Regulatory Authority anywhere in the world in
conformance with the requirements of such Regulatory Authority, and any amendments thereto. |
| |
1.20 | “Initial
Term” has the meaning set forth in Section 4.1. |
| |
1.21 | “Intellectual
Property” means (a) Patents, (b) Know-How, (c) copyrights and registrations
and applications for registration thereof, including all moral rights, (d) proprietary rights
in Know-How or other information, (e) other proprietary rights relating to any of the foregoing
(including remedies against infringement thereof and rights of protection of interest therein
under the laws of all jurisdictions) and (f) copies and tangible embodiments of any of the
foregoing. |
| |
1.22 | “Know-How”
means (a) any proprietary data, results, technology, and nonpublic information of any type
whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices,
techniques, methods, processes, inventions, developments, specifications, formulations, formulae,
in each case of any type or kind (patentable or otherwise), software, algorithms, marketing
reports and plans, market research, expertise, technology, test data (including pharmacological,
biological, chemical, biochemical, toxicological, preclinical and clinical test data), analytical
and quality control data, stability data, other study data, and procedures, that is not otherwise
disclosed or claimed in the Licensed Patents, and (b) the Materials; but excluding any chemical
or biological materials other than the Materials. |
| |
1.23 | “Licensed
Patents” means (a) all patents and patent applications listed in Exhibit D
on the Effective Date, (b) all Party Improvement Patents that are developed solely by Licensor,
(c) solely with respect to patent applications initially filed after the Effective Date that
claim priority to an Original Patent (i) substitutions, divisions, continuations, and continuations-in-part
of the Original Patents and (ii) reissues, reexaminations, utility models or designs, renewals
or extensions (including any supplementary protection certificates) of any Original Patent,
and (d) patents that issue from a patent application included in clause (a), clause (b),
or clause (c) and any confirmation patent or registration patent to any such issued patent.
As used in this definition, “Original Patents” means the patents
and patent applications included in clause (a) or clause (b). |
1.24 | “Licensed
Products” means any products manufactured, used, leased, sold, offered for
sale, imported, or exported by or on behalf of Licensee which, (a) consist of one or more
of the Base Product Families for use in the Field; and (b) (i) absent the licenses contained
herein, would infringe a Valid Claim of the Licensed Patents or (ii) are generated through
use or application of Licensor Know-How. For avoidance of doubt, a Licensed Product may include
Additional Active Ingredient(s) or be sold in combination with one or more products or components,
provided, however, that the licenses granted to Licensee hereunder extend only to such Licensed
Product (including when used in any Combination Product) and not such component or Additional
Active Ingredient alone if not otherwise administered with one or more of the Base Product
Families. |
| |
1.25 | “Licensee
Background IP” means Intellectual Property rights that Licensee either (i)
owned, controlled, or had rights with respect to prior to the Effective Date (excluding Patents
and Know-How licensed by Licensor to Licensee under the Original Agreement); or (ii) develops,
or acquires ownership, control, or rights with respect to, during the Term of this Agreement
but which are not Improvements. |
| |
1.26 | “Licensee
Know-How” means Know-How Controlled by Licensee before or during the Term of
this Agreement. |
| |
1.27 | “Licensor
Background IP” means Intellectual Property rights that Licensor either (i)
owned, controlled, or had rights with respect to prior to the Effective Date; or (ii) develops,
or acquires ownership, control, or rights with respect to, during the term of this Agreement
but which is not an Improvement. |
| |
1.28 | “Licensor
Know-How” means (a) Know-How Controlled by Licensor as of the Effective Date
that is necessary for the Exploitation of a Licensed Product in the Field, including but
not limited to the Know-How identified in Exhibit B and (b) Know-How included in Party Improvements
to the extent developed solely by Licensor. |
| |
1.29 | “Licensor’s
Laboratories” means the laboratory facilities occupied by Licensor at 1035
Cambridge Street, Cambridge MA 02141. |
| |
1.30 | “MAA”
means any new drug application or other marketing authorization application, in each case,
filed with the applicable Regulatory Authority in a country or other regulatory jurisdiction,
which application is required to commercially market or sell a pharmaceutical product (including
a biopharmaceutical product) in such country or jurisdiction (and any amendments thereto),
including all New Drug Applications (NDA) or equivalent submitted to the FDA in the United
States in accordance with the PHSA, BLA submitted to the FDA in the United States in accordance
with the FD&C Act, or any analogous application or submission with any Regulatory Authority
outside of the United States. |
| |
1.31 | “Major
Market” means any of France, Italy, Japan, Germany, South Korea, Spain, or
the United Kingdom. |
1.32 | “Materials”
has the meaning set forth in Section 3.1.4. |
| |
1.33 | “Net
Sales” means, with respect to any Licensed Product, the gross amounts invoiced
by Licensee, its Affiliates, or their respective distributors (each, a “Selling
Party”) to Third Parties (that are not a Related Party) for sales or other
commercial dispositions of such Licensed Product after deducting, if not previously deducted,
from the amount invoiced, the following insofar as they specifically pertain or are allocable
to the sale or other disposition of such Licensed Product and are included in such gross
amount invoiced or are otherwise actually incurred, allowed or paid, in each case as determined
in accordance with IFRS: |
| a) | discounts
(including trade, quantity and cash discounts) and other customary credits, charge-back payments
and rebates and any other similar allowances actually given to any Third Parties in the ordinary
course of business; |
| b) | product
returns, refunds, chargeback, rebates, credits or allowances given or made by reasons of,
if any, on account of recalls, claims, spoil, damaged goods, expiration of useful life or
otherwise, rejections or returns of items previously sold (including Licensed Products returned
in connection with recalls or withdrawals); |
| c) | retroactive
price reductions or billing corrections; |
| d) | Third
Party hospital buying group/group purchasing organization administration fees or managed
care organization rebates actually given; |
| e) | rebates
and similar payments made with respect to sales paid for by any Governmental or Regulatory
Authority such as patient assistance or other similar programs; |
| f) | a
fixed amount of one percent (1%) of gross sales to cover reasonable and customary insurance,
freight, shipping, handling, and other transportation costs incurred by a Selling Party in
shipping Licensed Products to a Third Party; |
| g) | import
taxes, export taxes, excise taxes, sales tax, value-added taxes, consumption taxes, duties
or other taxes levied on, absorbed, determined or imposed with respect to such sales (excluding
taxes assessed directly against the income derived from such sales) and government charges
directly related to the sales, delivery or use of Licensed Product; |
| h) | any
sales-based contributions actually made for “Contributions for Drug Induced Suffering”,
“Contribution for Measure for Drug Safety” or any other contributions for aiding
drug suffering in the amount determined by and payable to PMDA; and |
| i) | reasonable
deduction to reflect amounts previously included in Net Sales of Licensed Product that are
written off as uncollectible after reasonable collection efforts, in accordance with standard
practices of Licensee, provided that if any such amounts are subsequently collected, then
such amounts shall be added back to Net Sales for such Licensed Product. |
Any
of the items set forth above that would otherwise be deducted from the invoice price in the calculation of Net Sales but which are separately
charged to, and paid by, Third Parties shall not be deducted from the invoice price in the calculation of Net Sales. In the case of any
sale or transfer of Licensed Products other than in an arm’s length transaction exclusively for cash, such as barter or counter-trade,
Net Sales shall be determined by referencing Net Sales at which substantially similar quantities of Licensed Products are sold in an
arm’s length transaction for cash in the same country.
There
shall be no double counting in determining the foregoing deductions from gross amounts invoiced to calculate “Net Sales”
hereunder. The calculations set forth in this definition shall be determined from books and records maintained in accordance with IFRS
consistently applied.
Notwithstanding
the foregoing, with respect to transfers of Licensed Products for use in Clinical Trials, non-clinical development activities or other
development activities, Net Sales shall be determined on, and only on, the first sale by a Selling Party to a non-Related Party unless
such Selling Party is the last entity in the distribution chain for the Licensed Product.
Notwithstanding
the foregoing, the following will not be included in Net Sales: (1) samples of Licensed Product used to promote additional Net Sales,
in amounts consistent with normal business practices of Licensee or its Affiliates where the Licensed Product is supplied without charge
or at or below the actual manufacturing cost thereof (without allocation of indirect costs or any mark-up) determined in accordance with
IFRS; and (2) disposal or use of Licensed Products in Clinical Trial or under compassionate use, patient assistance, named patient use,
or test marketing programs or non-registrational studies or other similar programs or studies where the Licensed Product is supplied
without charge or at the actual manufacturing cost thereof (without allocation of indirect costs or any mark-up) determined in accordance
with IFRS.
If
a Licensed Product is sold as part of a Combination Product in a country in the Territory, Net Sales for the Licensed Product included
in such Combination Product in such country will be calculated as follows:
| i. | if
the Licensed Product is sold separately in such country and the Additional Active Ingredient(s)
in the Combination Product are sold separately in finished form in such country, Net Sales
for the Licensed Product shall be calculated by multiplying actual Net Sales of such Combination
Product in such country by the fraction A/(A+B), where A is the weighted (by sales volume)
average gross invoice price of the Licensed Product when sold separately in finished form
in such country and B is the weighted (by sales volume) average gross invoice price of the
Additional Active Ingredient(s) included in the Combination Product when sold separately
in finished form in such country; |
| ii. | if
the Licensed Product is sold separately in finished form in such country but the Additional
Active Ingredient(s) in the Combination Product are not sold separately in finished form
in such country, Net Sales for the Licensed Product shall be calculated by multiplying actual
Net Sales of such Combination Product in such country by the fraction A/D, where A is the
weighted (by sales volume) average gross invoice price of the Licensed Product when sold
separately in finished form in such country and D is the weighted (by sales volume) average
gross invoice price of the Combination Product in finished form in such country; |
| iii. | if
the Licensed Product is not sold separately in finished form in such country but the Additional
Active Ingredient(s) in the Combination Product are sold separately in finished form in such
country, Net Sales for the Licensed Product shall be calculated by multiplying actual Net
Sales of such Combination Product by the fraction 1- (B/D), where B is the weighted (by sales
volume) average gross invoice price of the Additional Active Ingredient(s) in the Combination
Product when sold separately in finished form in such country and D is the weighted (by sales
volume) average gross invoice price of the Combination Product in finished form in such country;
or |
| iv. | if
neither the Licensed Product nor the Additional Active Ingredient(s) in the Combination Product
are sold separately in finished form in such country, the Parties shall determine Net Sales
for the Licensed Product in such Combination Product by mutual agreement based on the relative
contribution of the Licensed Product and each Additional Active Ingredient to the Combination
Product, and shall take into account in good faith any applicable allocations and calculations
that may have been made for the same period in other countries. |
1.34 | “Out-of-Pocket
Costs” means costs and expenses paid to Third Parties (or payable to third
parties and accrued in accordance with GAAP) other than Affiliates or employees. |
| |
1.35 | “Party
Improvements” means Improvements developed solely by Licensor, solely by Licensee,
or jointly by Licensor and Licensee. |
1.36 | Party
Improvement Patents” means Improvement Patents developed solely by Licensor,
solely by Licensee, or jointly by Licensor and Licensee. During the Term, all Party Improvement
Patents that are developed solely by Licensor shall be set forth in Exhibit D, as updated
from time to time pursuant to the terms of this Agreement. During the Term, all Party Improvement
Patents that are not solely developed by Licensor shall be set forth in Exhibit F, as updated
from time to time pursuant to the terms of this Agreement. |
| |
1.37 | “Patent
Expenses” means all reasonable fees, costs, and expenses (including attorneys’
fees) paid or incurred in the preparation, filing, prosecution, issuance, and/or maintenance
of the Licensed Patents. |
| |
1.38 | “Patent”
means any patent and provisional and non-provisional patent application, together with all
priority applications, additions, divisions, continuations, continuations-in-part, substitutions,
and reissues claiming priority thereto, as well as any reexamination, post-grant proceeding,
utility model, certificate of invention and design patent, application, registration and
application, extension, registration, patent term extension, supplemental protection certificate,
renewal and the like with respect to any of the foregoing and all foreign counterparts thereof. |
| |
1.39 | “Phase
1 Clinical Trial” means a Clinical Trial (or any arm thereof) of a pharmaceutical
product (including a biopharmaceutical product) with the endpoint of determining initial
tolerance, safety, metabolism, pharmacokinetic, or pharmacodynamic information in single
dose, single ascending dose, multiple dose, or multiple ascending dose regimens, that satisfies
the requirements of U.S. federal regulation 21 C.F.R. § 312.21(a) and its successor
regulation or equivalents in other jurisdictions. |
| |
1.40 | “Phase
2 Clinical Trial” means a Clinical Trial (or any arm thereof) of a pharmaceutical
product (including a biopharmaceutical product) with the endpoint of evaluating its effectiveness
for a particular Indication or Indications in one or more specified doses or its short term
tolerance and safety, as well as its pharmacokinetic and pharmacodynamic information in patients
with the Indications under study, that is prospectively designed to generate sufficient data
(if successful) to commence a Phase 3 Clinical Trial for such product, and that satisfies
the requirements of U.S. federal regulation 21 C.F.R. § 312.21(b) and its successor
regulation or equivalents in other jurisdictions. |
| |
1.41 | “Phase
3 Clinical Trial” means a Clinical Trial (or any arm thereof) of a pharmaceutical
product (including a biopharmaceutical product) on a sufficient number of patients, which
trial the FDA or equivalent Regulatory Authority in other jurisdictions permits to be conducted
under an open IND and is designed to: (a) establish that such pharmaceutical product is safe
and efficacious for its intended use; (b) define warnings, precautions and adverse reactions
that are associated with such pharmaceutical product in the dosage range to be prescribed;
and (c) support the filing of an MAA with a Regulatory Authority for such pharmaceutical
product, and that satisfies the requirements of U.S. federal regulation 21 C.F.R. §
312.21(c) and its successor regulation or equivalents in other jurisdictions. |
| |
1.42 | “Regulatory
Approval” means all technical, medical and scientific licenses, registrations,
authorizations and approvals (including approvals of new drug applications, supplements and
amendments, pre- and post- approvals, pricing and Third Party reimbursement approvals, and
labeling approvals) of any Regulatory Authority that are necessary for the use, development,
manufacture, and commercialization of a pharmaceutical product in a regulatory jurisdiction. |
| |
1.43 | “Regulatory
Authority” means, with respect to a given country, any national (e.g., the
FDA), supra-national (e.g., the European Commission, the Council of the European Union, or
the European Medicines Agency), regional, state or local regulatory agency, department, bureau,
commission, council or other governmental authority involved in the granting of a Regulatory
Approval. |
1.44 | “Sublicense”
has the meaning set forth in Section 2.3. |
| |
1.45 | “Sublicensee”
has the meaning set forth in Section 2.3. |
| |
1.46 | “Sublicense
Fees” means any and all consideration paid to Licensee, or any of its Affiliates,
by a Sublicensee as consideration for a sublicense of, or other right, license, option, privilege,
or immunity with respect to, any Licensed Product, Licensed Patent, or Licensor Know-How
granted to Licensee hereunder, including license fees, upfront payments, milestone payments,
and royalties payable on sales of Licensed Products. For avoidance of doubt, “Sublicense
Fees” shall exclude any consideration for the issuance of equity interests in Licensee
to the extent such equity is issued at or below fair market value. |
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1.47 | “Sublicensee
Improvements” means Improvements developed by Sublicensee, whether solely or
jointly with Licensor and/or Licensee. |
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1.48 | “Sublicensee
Improvement Patents” means Improvement Patents developed by Sublicensee, whether
solely or jointly with Licensor and/or Licensee. |
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1.49 | “Technology”
means the platforms, products, and process(es) of Licensor that are used for converting iPSCs
to iMSCs, and for converting iMSCs to Base Product Families. |
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1.50 | “Term”
means the period of time beginning on the Effective Date and ending as specified in Section
4 hereof. |
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1.51 | “Territory”
means worldwide. |
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1.52 | “Third
Party” means any person or entity other than Licensor, Licensee or their respective
Affiliates. |
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1.53 | “Third
Party Patent” means any Patent owned or controlled by a Third Party that is
necessary to avoid infringement of such Patent in the manufacture, use, offer for sale, sale,
or importation of Licensed Products. |
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1.54 | “Valid
Claim” means (a) a claim of a granted and unexpired Licensed Patent that (i)
has not been rejected, revoked, or held to be invalid or unenforceable by a court or other
authority of competent jurisdiction, from which decision no appeal can be further taken or
(ii) has not been finally abandoned, disclaimed or admitted to be invalid or unenforceable
through reissue or disclaimer; or (b) a claim included in a pending patent application which
is a Licensed Patent that (i) has not been pending for more than seven (7) years from the
effective date of filing for such patent application (provided, however that for purposes
of clarity, in the event such pending claim subsequently is subsequently granted, then such
claim shall again be a Valid Claim as of the date of grant of such claim) or (ii) has not
been finally determined to be unallowable by the applicable governmental authority (from
which no appeal is or can be taken). |
Section
2
Grant
of Licenses
2.1 | License
Grant. Subject to the terms and conditions of this Agreement, Licensor, on behalf of
itself and any successors and/or assigns, hereby grants to Licensee an exclusive (even as
to Licensor and its Affiliates), non-transferable (except as provided in Section 9.3), royalty-bearing
license, with the right to grant sublicenses pursuant to Section 2.4, under the Licensed
Patents to make, have made, use, sell, offer for sale, lease, import, export, or otherwise
Exploit Licensed Products in the Field throughout the Territory. Subject to the terms and
conditions of this Agreement, Licensor, on behalf of itself and any successors and/or assigns,
hereby grants to Licensee an exclusive (even as to Licensor and its Affiliates), non-transferable
(except as provided in Section 9.3) license, with the right to grant sublicenses pursuant
to Section 2.4, under the Licensor Know-How to make, have made, use, sell, offer for sale,
lease, import, export, or otherwise Exploit Licensed Products in the Field throughout the
Territory. |
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2.2 | License
Grant by Licensor of Jointly Developed and Licensee Developed Improvements. Subject to
the terms and conditions of this Agreement, Licensor, on behalf of itself and any successors
and/or assigns, hereby grants to Licensee an exclusive, (even as to Licensor and its Affiliates),
royalty-free, fully paid up, irrevocable license, with the right to grant sublicenses pursuant
to Section 2.4, under any Party Improvement Patents that are jointly developed by the Parties,
or solely developed by Licensee, to make, have made, use, sell, offer for sale, lease, import,
export, or otherwise Exploit Licensed Products in the Field throughout the Territory. Subject
to the terms and conditions of this Agreement, Licensor, on behalf of itself and any successors
and/or assigns, hereby grants to Licensee an exclusive, (even as to Licensor and its Affiliates),
royalty-free, fully paid up, irrevocable license, with the right to grant sublicenses pursuant
to Section 2.4, under any Know-How included in Party Improvements that is jointly developed
by the Parties or solely developed by Licensee to make, have made, use, sell, offer for sale,
lease, import, export, or otherwise Exploit Licensed Products in the Field throughout the
Territory. |
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2.3 | Affiliates.
The Parties recognize that each Party may perform some or all of its obligations under this
Agreement through Affiliates or contractors designated by such Party (“Contractors”);
provided, however, that each Party shall remain responsible for and be guarantor of the performance
by its Affiliates and Contractors and shall cause its Affiliates and Contractors to comply
with the provisions of this Agreement in connection with such performance. Each Party hereby
expressly waives any requirement that the other Party exhaust any right, power or remedy,
or proceed against an Affiliate or Contractor, for any obligation or performance hereunder
prior to proceeding directly against such Party. Wherever in this Agreement a Party delegates
responsibility to an Affiliate or Contractor (i) such Affiliate or Contractor may not make
decisions inconsistent with this Agreement, amend the terms of this Agreement or act contrary
to its terms in any way, (ii) such delegation shall not relieve such Party of any of its
obligations under this Agreement, and (iii) any breach of the terms and conditions of this
Agreement by any Affiliate or Contractor shall be deemed a direct breach by such Party of
such terms and conditions. |
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2.4 | Sublicenses.
Licensee may grant sublicenses (each, a “Sublicense”) of its licensed
rights under Sections 2.1 and 2.2 to one or more sublicensees (each, a “Sublicensee”)
so long as: (a) each Sublicense is in writing, and includes other industry standard provisions
for the development and/or commercialization of Licensed Products, including, without limitation,
reasonable diligence requirements, patent marking requirements, development and commercialization
reporting requirements, and insurance requirements, in each case if and to the extent such
provisions would customarily be included in such a sublicense based on then-current industry
standards; (b) the terms of each Sublicense are consistent with applicable terms and conditions
of this Agreement and the Existing License Agreements, (c) each Sublicense is negotiated
by Licensee in good faith, for a proper commercial purpose, on reasonable arm’s-length
commercial terms, (d) each Sublicense names Licensor as a third-party beneficiary thereof;
and (e) the applicable Sublicensee has, or has the ability to acquire, adequate resources
(including scientific, technical and financial) to perform its obligations under such sublicense,
as reasonably determined by Licensee at the time of entry into the Sublicense. Licensee will
be responsible for requiring compliance by the applicable Sublicensee of each such Sublicense
entered into by Licensee and for reasonably enforcing the terms of such Sublicenses, including,
without limitation, requiring such applicable Sublicensee to make any of the payments provided
for thereunder. Licensee will provide Licensor with a complete, confidential copy of each
such Sublicense executed by Licensee and any amendments thereto within thirty (30) days of
the execution of said Sublicense or any such amendments thereto and will promptly notify
Licensor of the termination of any such Sublicense. Licensee’s grant of any Sublicense
to any Sublicensee shall not relieve Licensee of any of its obligations under this Agreement,
except to the extent that Licensee is, in accordance with the terms and conditions of this
Agreement, excused from paying milestones and royalties with respect to Licensed Product
development and sales by the Sublicensee under such Sublicense. Any breach of the terms and
conditions of this Agreement by any Sublicensee shall be deemed a direct breach by Licensee
of such terms and conditions. Licensee shall not enter into Sublicenses structured to avoid
payment of fees to Licensor. |
2.5 | Restricted
Entities. During the Term of this Agreement, Licensor shall not engage in discussions,
negotiations or similar communications with the companies listed in Exhibit C, including
such companies’ Affiliates, regarding licenses, collaboration, co-development or any
other type of agreement relating to the Licensed Products in the Field without the prior
written permission of Licensee. At no time during the Term of this Agreement shall Licensor
have the right to license or sublicense Licensed Products under the Licensed Patents or Licensor
Know-How in the Field while the Licensee has the exclusive rights under this Agreement with
respect to such Licensed Products, Licensed Patents, and Field. For the avoidance of doubt,
Licensee’s sublicense rights are not limited to this list of potential sublicensees,
and, subject to Section 2.4, the existence of this list in no way limits Licensee’s
right to sublicense under this Agreement. |
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2.6 | Multi-Tier
Sublicensing. Subject to Section 2.4, each Sublicensee and Licensee has the right to
sublicense the rights granted to it under Sections 2.1 and 2.2 to any Contractor pursuant
to a written agreement to subcontract the responsibility to perform, on such Sublicensee’s
or Licensee’s behalf, activities for which it is responsible under the applicable license
or sublicense agreement provided, however, that (a) the terms of such agreement are consistent
with applicable terms and conditions of this Agreement and the Existing License Agreements
and (b) as between the Parties, Licensee shall at all times remain responsible for, and shall
be liable under this Agreement with respect to, any breach of this Agreement resulting directly
or indirectly from the performance, or failure to perform, by any such Contractors. |
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2.7 | Retained
Rights; Requirements. |
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2.6.1 | Retained
Rights. Notwithstanding any provision of this Agreement to the contrary, any and all
licenses granted to Licensee under this Agreement are subject to (a) Licensor’s and
its Affiliates’ right to use and otherwise perform activities, and to permit academic,
government, and not-for-profit institutions or agencies to use and otherwise perform activities,
under the Licensed Patents and Licensor Know-How (i) in the Field for non-commercial research,
academic, educational, and all other non-commercial purposes, and (ii) outside of the Field
for all commercial and non-commercial purposes, (b) Licensor’s and its Affiliates’
right to use and otherwise perform activities under the Licensed Patents and Licensor Know-How
(i) to conduct research and development activities for Licensor and/or its Affiliates on
behalf of itself (or themselves) to generate improvements and other new Patents and Know-How,
(ii) for the provision of services to Licensee and/or Sublicensees, and (iii) for the provision
of services to other Third Parties, including commercial contract research, development or
manufacturing services, to the extent such services do not breach Licensees exclusive rights
under this Agreement, and (c) any licenses or other rights granted by Licensor to Third Parties
under the Existing License Agreements. All rights and interests not expressly granted to
Licensee under this Agreement are reserved by Licensor (the “Reserved Interests”)
for itself, its Affiliates, its licensors and its and their respective licensees and sublicensees.
It shall not be a breach of this Agreement for Licensor, acting directly or indirectly, to
practice or Exploit its Reserved Interests in any manner anywhere in the Territory. |
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2.6.2 | Right
to Publish. Subject to this Section 2.6.2, any and all licenses granted hereunder are
subject to the right of (a) Licensor to review Licensee’s proposed publications of
scientific findings related to the Licensed Patents, Licensor Know-How, and/or Party Improvements
(collectively, “Licensor Content”) and (b) Licensee to review Licensor’s
proposed publications of scientific findings related to the Licensed Products in the Field
(collectively, “Licensee Content” and, together with Licensor Content,
“Publication Content”). If the publishing Party “Publishing
Party” desires to submit any publication related to the other Party’s
(“Reviewing Party’s”) Publication Content (each, a “Proposed
Publication”), then the Publishing Party will provide the Reviewing Party with
prior written notice of such Proposed Publication and a copy of such Proposed Publication.
The Reviewing Party will use reasonable efforts to complete its review of such Proposed Publication
promptly, and in any event will complete its review within thirty (30) days of receipt of
the Proposed Publication (or ten (10) days in case of abstracts) (the “Review
Period”), provided that the Reviewing Party shall be deemed to have given its
consent if the Reviewing Party does not complete its review within the Review Period. The
Reviewing Party shall notify the Publishing Party of any of such Reviewing Party’s
Confidential Information that is contained in such Proposed Publication. In response to such
notification, the Publishing Party will promptly delete any of the Reviewing Party’s
Confidential Information from the Proposed Publication that the Reviewing Party has identified
during the Review Period. The Reviewing Party will have the right to delay submission of
the Proposed Publication for up to an additional thirty (30) days if the Reviewing Party
determines, in its sole discretion, that publication of the Proposed Publication would have
negative effects on the Reviewing Party’s Patent rights. In the event that the Reviewing
Party decides to delay submission of the Proposed Publication, the Reviewing Party shall
inform Publishing Party of such decision within the Review Period, and the Parties shall
reasonably cooperate in order to resolve any concerns with the Proposed Publication within
such Review Period (as may be extended if the publication has already been submitted). |
2.6.3 | U.S.
Federal Funding. Any and all licenses granted under patents supported by U.S. federal
funding are subject to the rights, conditions, and limitations imposed by U.S. law (see 35
U.S.C. §202 et seq. and regulations pertaining thereto), including: (a) the royalty-free,
non-exclusive license granted to the U.S. government; and (b) the requirement that any products
covered by an issued claim and sold in the U.S. will be substantially manufactured in the
United States. Each Party agrees to inform the other Party of those Party Improvements that
are developed, reduced to practice or invented by such Party’s personnel and agents
or the personnel or agents of such Party’s Affiliates (or that are Controlled by such
Party or its personnel or agents or the personnel or agents of its Affiliates) during the
Term and beyond with the support (either entirely or in part) of U.S. federal funding, and
to provide all information and documentation to Licensor that Licensor may request to secure
patent rights for those inventions, including, but not limited to, grant numbers, contract
numbers, and names of granting and contracting institutions and organizations. |
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2.7 | No
Grant of Other Know-How or Patent Rights. Each Party understands and acknowledges that
the other Party owns its own Intellectual Property and all rights therein. Except as otherwise
expressly provided in this Agreement, under no circumstances shall a Party hereto, as a result
of this Agreement, obtain any ownership interest or license, or be deemed to obtain any ownership
interest or license, in or to any technology, Know-How, Patents, products, or materials of
the other Party, including, but not limited to, items Controlled or developed by the other
Party, at any time during this Agreement. This Agreement does not create, and shall under
no circumstances be construed or interpreted as creating, an obligation on the part of either
Party to grant any license to the other Party other than as expressly set forth herein. Any
further contract or license agreement between Licensor and Licensee shall be in writing.
No licenses are implied by Licensor to Licensee or by Licensee to Licensor. Except as explicitly
set forth in this Agreement, neither Party shall be deemed by estoppel or implication to
have granted the other Party any license or other right to any Intellectual Property of such
Party or its Affiliates. |
Section
3
Collaboration
between the Parties, Deliverables, and Payments
3.1 | Know-How
Documentation and Technology Transfer. The Parties will cooperate as set forth in this
Section 3.1 to assist Licensee in the understanding and implementation of the Licensed Patents
and Licensor Know-How set forth in Exhibit B. |
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3.1.1 | Technical
Assistance at No Charge. Licensor shall, upon the written request (including via email)
of Licensee made from time to time during the Initial Term of this Agreement (or such shorter
period as is specified herein), provide to personnel of Licensee (or Sublicensees or Contractors)
the following technical assistance: |
| a. | Reasonable
access to Licensor’s protocol binders and other documentation to the extent the same
constitutes Licensor Know-How set forth in Exhibit B and in the form (physical or electronic)
in which Licensor retains such binders and other documentation; |
| b. | Reasonable
input and support to assist Licensee in Licensee’s efforts to assemble the documentation
of Licensor Know-How as set forth in Exhibit B; |
| c. | Reasonable
access to Licensor’s Laboratories to allow Licensee, its Sublicensees and its Contractors
to observe lab processes, to enable Licensee and its Sublicensees and Contractors to learn
in person how to practice the Licensor Know-How set forth in Exhibit B; and |
| d. | Reasonable
access to the results of work conducted by Licensor or its Affiliates under U.S. federal
contract number HT94252310787. |
3.1.2 | Technical
Assistance at an Hourly Rate. To the extent additional technical assistance is required
by Licensee beyond the services described in Section 3.1.1, at the written request of Licensee
(including by email), the Parties will negotiate in good faith the terms of one or more separate
agreements pursuant to which Licensor would provide additional technical assistance. Such
additional technical assistance may include, without limitation, the following: |
| a. | Provision
of reasonable technical input, reviews and commentary on SOPs, batch records and other written
documentation needed to transfer the Licensor Know-How set forth in Exhibit B to Licensee,
its Sublicensees and its Contractors; |
| b. | Reasonable
access to Licensor personnel to attend meetings at Licensee’s request to assist Licensee
to document the Licensor Know-How set forth in Exhibit B; |
| c. | Reasonable
support for SOP revision, updating, and troubleshooting when Licensee and/or its Contractors
implement the SOPs; and |
| d. | Reasonable
training and knowledge transfer to Licensee its Sublicensees, and its Contractors to the
extent reasonably necessary to enable Licensee to practice the Licensor Know-How set forth
in Exhibit B. |
3.1.3 | In
the event Licensee requests that Licensor provide any of the access or assistance described
in Section 3.1.1 or Section 3.1.2 (collectively, “Technical Assistance”),
such Technical Assistance shall be provided subject to the following conditions: |
| a. | Licensee
shall notify Licensor in writing (including via email) of the dates on which Licensee requests
Technical Assistance, and submit a schedule of the proposed subjects, estimated man hours,
dates and locations (which may be Licensor’s Laboratories) for Licensor to provide
the requested Technical Assistance. |
| b. | Licensor
shall promptly advise Licensee whether it can furnish the requested Technical Assistance
consistent with the proposed schedule and, if not, propose a reasonable alternative. |
| c. | Licensor
shall not be required to provide Licensee with more than one hundred twenty (120) man hours
of support in connection with the no charge Technical Assistance described in Section 3.1.1. |
| d. | Licensor
shall have no obligation under Section 3.1.1 to (i) create or generate any new data, results,
materials or other Licensor Know-How or (ii) translate, convert or otherwise modify any Licensor
Know-How into any form other than the form in which Licensor maintains it for its own use. |
| e. | Licensor
shall perform the requested Technical Assistance using the same degree of care, skill, and
diligence with which it performs, or would perform, similar activities for its own sake. |
| f. | Licensor
shall only be required to provide Licensee with the access described above during reasonable
business hours and to the extent such access does not impede or distract from Licensor’s
normal business operations. All materials received and information observed by Licensee and
its representatives in connection with such access shall be deemed Licensor Confidential
Information that is subject to Licensee’s obligations under Section 7. |
3.1.4 | As
soon as reasonably practicable after the Effective Date, Licensor shall provide Licensee
with the materials listed in Exhibit B (collectively, the “Materials”).
Licensee will not (a) use the Materials for any purpose other than the exercise of its license
rights under this Agreement, (b) provide any Third Party with access to any Materials other
than as permitted under Section 2.3, or (c) use or authorize the use of any Materials on
or in human beings. The Parties will negotiate in good faith the terms of one or more separate
agreements pursuant to which Licensor would provide iPSC/iMSC cell lines/targeted proteins
that may be reasonably requested by Licensee, in accordance with reasonable time frames for
production and at a fair market price. |
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3.1.5 | In
order to facilitate the ongoing collaboration under this Section 3.1, during the Initial
Term the Parties shall meet monthly (either in person or by videoconference) for a 1.5 hour
meeting at which (a) each Party will provide an overview of its development activities relating
to the Technology, the Licensed Products in the Field and any associated Improvements and
(b) the Parties will discuss any new Technical Assistance requests and the status of any
existing Technical Assistance requests. All information disclosed by either Party in connection
with any such meetings will be subject to the provisions of Section 7. |
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3.2 | Licensee
Diligence Obligations. Licensee (either directly or through its Sublicensees) will use
Commercially Reasonable Efforts to develop and secure Regulatory Approval for at least one
(1) Licensed Product. Without limiting the foregoing, Licensee must achieve the following
milestones (“Milestones”): (a) within five (5) years after the
Effective Date, Licensee shall submit an IND for a Licensed Product, and (b) within twenty
four (24) months after submission of the IND, Licensee shall have dosed the first patient
with a Licensed Product in a Phase I Clinical Trial in the United States or in a Major Market
Country. It shall be deemed a material breach of this Agreement and Licensor may elect to
terminate this Agreement in its entirety if any of the following occur: (i) Licensee has
not submitted an IND for any Licensed Product on or before the date that is five (5) years
after the Effective Date, (ii) Licensee has not dosed a patient with any Licensed Product
in a Phase I Clinical Trial in the United States or in a Major Market Country on or before
the date that is twenty four (24) months after submission of the IND, or (iii) Licensee otherwise
breaches any of its diligence obligations under this Section 3.2. Licensee (either directly
or through its Sublicensees) will use Commercially Reasonable Efforts to commercialize each
Licensed Product in each jurisdiction where it receives Regulatory Approval. |
3.3 | Payments.
In consideration of the rights granted to Licensee under this Agreement, Licensee agrees
to pay to Licensor the following fees, as further detailed in Exhibit A: |
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3.3.1 | Payment
During the Initial Term. Licensee shall pay the fixed monthly amount specified in Exhibit
A, paragraph 1.a, during the Initial Term. |
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3.3.2 | Existing
Amounts Payable. Licensee shall pay the existing accrued amounts as specified in Exhibit
A, paragraph 1.b. |
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3.3.3 | Patent
Costs. Licensee shall pay the amounts set forth in Exhibit A, paragraph 1.c. |
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3.3.4 | Development
Milestone Fees Related to Licensed Products. Licensee shall pay Licensor based on achievement
by Licensee or its Affiliates (but not Sublicensees) of the development milestones identified
in paragraph 2 of Exhibit A, and in accordance with the payment schedule and other conditions
set forth therein. |
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3.3.5 | Royalty.
Commencing upon the First Commercial Sale of a Licensed Product by Licensee or its Affiliates
(but not Sublicensees), in any country in the Territory, on a calendar quarter and country
by country basis, Licensee shall pay to Licensor a Royalty on Net Sales of such Licensed
Product in the amount set forth in Exhibit A, paragraph 3. |
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3.3.6 | Sublicense
Income. Licensee shall pay to Licensor the Sublicense Fees specified in Exhibit A, paragraph
4. |
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3.3.7 | Priority
Review Voucher Sale Payments. Licensee shall pay to Licensor the Priority Review Voucher
Sale Payments specified in Exhibit A, paragraph 5. |
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3.3.8 | Currency;
Currency Conversion. Licensee shall pay in U.S. dollars all amounts due to Licensor pursuant
to this Agreement. All payments due to Licensor hereunder shall be made by wire transfer
of immediately available funds into an account designated by Licensor. For the purpose of
converting any local currency into U.S. dollars to determine any amounts payable under this
Agreement, the rate of exchange to be applied shall be the average rate of exchange in effect
during the twenty (20) business days immediately preceding the day on which such amounts
become due and payable under this Agreement as reported in the Wall Street Journal. |
3.3.9 | Audit
and Inspection Rights. Licensee and its Affiliates will maintain complete and accurate
records in sufficient detail to permit Licensor to confirm the accuracy of the calculation
of payments under this Agreement. Upon reasonable prior notice, such records shall be available
during regular business hours (without undue disruption of Licensee’s business) for
a period of three (3) years from the end of the calendar year to which they pertain for examination
by an independent accountant selected by the Licensor and reasonably acceptable to Licensee,
for the sole purpose of verifying the accuracy of the reports and payments furnished by Licensee
pursuant to this Agreement. Audits may not be requested more than once per year, and no period
may be audited more than once. Any such auditor shall enter into a confidentiality agreement
with Licensee, and shall not disclose Licensee’s Confidential Information, except to
the extent such disclosure is necessary to verify the accuracy of the reports furnished by
Licensee or the amount of payments due by Licensee to Licensor under this Agreement. The
auditor may not be compensated on a commission, bonus, or any other payment that depends
on the result of the audit or amounts due or paid as a result of the audit. Any undisputed
amounts shown to be owed but unpaid shall be paid within thirty (30) days from the accountant’s
report, plus interest (as set forth in Section 3.3.11) from the original due date. Licensor
shall bear the full cost of such audit. |
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3.3.10 | Taxes.
Each Party shall be solely responsible for the payment of all taxes imposed on its share
of income arising directly or indirectly from the efforts of the Parties under this Agreement.
The Parties agree to cooperate with one another and use commercially reasonable efforts to
reduce or eliminate tax withholding or similar obligations in respect of payments made by
a Party to the other Party under this Agreement. To the extent Licensee is required to deduct
and withhold taxes on any payment to Licensor hereunder, Licensee shall pay the amounts of
such taxes to the proper governmental authority in a timely manner and promptly transmit
to Licensor an official tax certificate or other evidence of such withholding sufficient
to enable Licensor to claim such payment of taxes. Licensor shall provide Licensee with any
tax forms that may be reasonably necessary in order for Licensee to not withhold tax or to
withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party
shall provide the other with reasonable assistance to enable the recovery, as permitted by
Applicable Laws, of withholding taxes, value added taxes, or similar obligations resulting
from payments made under this Agreement, such recovery to be for the benefit of the Party
bearing such withholding tax or value added tax. |
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3.3.11 | Late
Payment. If Licensor does not receive payment of any sum due to it on or before the due
date (each, a “Late Payment”), Licensee shall pay to Licensor an
amount equal to two percent (2%) of such Late Payment (“Late Payment Penalty”),
and such Late Payment shall not be considered paid in full until Licensor has received from
Licensee both the full amount of such Late Payment and the Late Payment Penalty. For the
avoidance of doubt, payment by Licensee within sixty (60) days past the due date will not
be considered a Late Payment subject to a Late Payment Penalty. |
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3.3.12 | Offset
for Third Party Royalties. If either Licensee or any of its Sublicensees is required
to pay a royalty to a Third Party as a result of the manufacture, use, sale, distribution,
importation, or other Exploitation of a Licensed Product for a license or other authorization
under a Third Party Patent, then Licensee shall be entitled to, on a country-by-country basis,
offset against any royalty payable to Licensor under this Agreement an amount equal to fifty
percent (50%) of such royalty paid to such Third Party with respect to such sales, provided
that in no event will any offset under this Section 3.3.12 reduce the royalties payable by
Licensee for a given Licensed Product in a given country in any given calendar quarter to
less than fifty percent (50%) of the amounts otherwise payable by Licensee for such Licensed
Product in such country in such calendar quarter pursuant to paragraph 3 of Exhibit A. |
Section
4
Term,
Renewal, Termination, and Survival
4.1. | The
term of this Agreement shall begin on the Effective Date and, unless earlier terminated pursuant
to this Section 4, endure until the one (1) year anniversary of the Effective Date (the “Initial
Term”). Thereafter, the term shall be renewed for sequential one (1) year periods
(each a “Renewal Term”) unless (a) a notice of nonrenewal is provided
in writing by Licensee to Licensor at least ninety (90) days prior to the expiration of the
Initial Term or the then-current Renewal Term, (b) this Agreement is earlier terminated pursuant
to this Section 4, or (c) Licensee is subject to bankruptcy proceedings under Chapter 7 of
the U.S. Bankruptcy Code and is in breach of this Agreement due to failure to timely pay
any amount due under this Agreement. The Initial Term together with any applicable Renewal
Terms are referred to herein as the “Term”. |
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4.2. | Either
Party may, without prejudice to any other remedies available to it at law or in equity, terminate
this Agreement upon written notice to the other Party in the event that the other Party (the
“Breaching Party”) shall have materially breached or defaulted
in the performance of any of its obligations. The Breaching Party shall have thirty (30)
days after written notice thereof was provided to the Breaching Party by the non-breaching
Party to remedy such default. If the Breaching Party has failed to cure any such breach or
default prior to the expiration of such thirty (30) day period, the non-breaching Party shall
have the right to terminate the Agreement, which termination shall become effective by sending
a written notice of termination to the Breaching Party. Notwithstanding any provision of
this Agreement to the contrary, a Party’s right to terminate under this Section 4.2
shall not be subject to the provisions set forth in Section 8, shall not expire, and any
such termination shall take effect upon written notice to the other Party without application
of any cure period otherwise provided under this Agreement (except the cure period set forth
in the second sentence of this Section 4.2 or the grace period set forth in Section 3.3.11). |
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4.3. | Either
Party shall have the right to terminate this Agreement upon written notice as a result of
the filing or institution of bankruptcy, liquidation or receivership proceedings, or upon
an assignment of a substantial portion of the assets for the benefit of creditors by the
other Party; provided that such termination shall be effective only if such proceeding is
not dismissed within ninety (90) days after the filing thereof. |
| |
4.4. | Licensee
may terminate this Agreement at any time upon ninety (90) days prior written notice. |
| |
4.5. | Without
limiting Licensor’s rights under Section 4.2, except to the extent unenforceable under
Applicable Law, Licensor may terminate this Agreement by written notice to Licensee in the
event of a breach of Section 9.9 by Licensee, its Affiliates or their respective Sublicensees
or in the event that Licensee, its Affiliates, or any of their respective Sublicensees challenges,
in any formal proceeding, the validity, patentability, enforceability, scope, construction
or inventorship of any of the Licensed Patents or assists any Third Party in any such challenge
(each, a “Patent Challenge”). If a Sublicensee brings any such
Patent Challenge or assists a Third Party in bringing any such Patent Challenge (except as
required under a court order or subpoena), then Licensor will send a written demand to Licensee
to terminate such sublicense. If Licensee fails to so terminate such sublicense within thirty
(30) days after Licensor’s demand, Licensor may terminate this Agreement. In any country(ies)
where Licensor may not terminate this Agreement in the event of a Patent Challenge, if: (a)
Licensee or any of its Affiliates bring a Patent Challenge against Licensor; (b) Licensee
or any of its Affiliates assists a Third Party in bringing a Patent Challenge against Licensor
(except as required under a court order or subpoena); or (c) any Sublicensee brings a Patent
Challenge or assists a Third Party in bringing a Patent Challenge (except as required under
a court order or subpoena), Licensor sends a written demand to Licensee to terminate such
sublicense, and Licensee fails to so terminate such sublicense within thirty (30) days after
Licensor’s demand, and such Patent Challenge is not successful (i.e., the Licensed
Patent(s) subject to such Patent Challenge retain Valid Claims), then all payments payable
by Licensee to Licensor under this Agreement shall be doubled. In the event that such a Patent
Challenge is successful, Licensee will have no right to recoup any payments made during the
period of such Patent Challenge. |
| |
4.6. | Upon
termination or expiration of this Agreement for any reason, Licensee’s rights to the
Licensed Patents and Licensor Know-How (inclusive of Licensed Products), which have been
granted hereunder and all use thereof will terminate except for rights that are subject to
a Sublicense at the time of such termination or expiration. All Sublicenses granted by Licensee
shall survive the Term and, unless terminated consistent with the applicable terms of the
Sublicense, shall continue until the expiration of the last to expire Valid Claim of a Licensed
Patent in any applicable jurisdiction in the Territory. For the avoidance of doubt, Licensee
would remain obligated to pay Sublicense Fees on any such surviving Sublicenses. If this
Agreement is terminated or expires for any reason, and if Licensee requests that a given
Sublicense be transferred to Licensor (a “Transferred Sublicense”),
then such Transferred Sublicense shall be considered a direct license from Licensor to the
Sublicensee under such Transferred Sublicense, unless such Sublicensee is (a) an Affiliate
of Licensee, (b) in material default of any provision of this Agreement or the applicable
Sublicense, or (c) the basis for termination of this Agreement is due to such Sublicensee’s
actions or inactions ((a)-(c), an “Ineligible Sublicensee”); provided
that such Sublicensee agrees in writing that (i) Licensor is entitled to enforce all relevant
provisions of the Sublicense, including payment provisions, directly against such Sublicensee,
and (ii) Licensor shall not assume, and shall not be responsible to such Sublicensee for,
any representations, warranties or obligations (including, without limitation, any obligations
to provide services or information) of Licensee to such Sublicensee, other than to permit
such Sublicensee to exercise any rights to the Licensed Patents and Licensor Know-How to
the extent consistent with the terms of this Agreement. |
| |
4.7. | Expiration
or termination of this Agreement will not release either Party from any obligation that matured
prior to the effective date of such expiration or termination. Upon expiration or termination
of this Agreement for any reason, any unpaid amounts payable to Licensor (including all unpaid
amounts under Section 3.3.1, Section 3.3.2 and Section 3.3.3) shall become due and payable
no later than sixty (60) days following the effective date of such expiration or termination,
and payment thereof shall remain an ongoing obligation of Licensee until such amount is paid
in full. Notwithstanding any provision of this Agreement to the contrary, Licensee’s
obligation to pay Sublicense Fees to Licensor that accrue with respect to each Sublicense
prior to expiration or termination of such Sublicense remains in effect, provided however
that to the extent any Sublicensee becomes a direct licensee of Licensor pursuant to Section
4.6, Licensee shall have no further obligation to pay any Sublicense Fees once such Sublicensee
has entered into a direct license with Licensor with respect to such Transferred Sublicense. |
| |
4.8. | The
following provisions will survive termination or expiration of this Agreement: Sections 1;
2.2; 2.6; 2.7; 3.3 including Exhibit A (with respect to any payments that accrue prior to
termination or expiration); 4.5; 4.6; 4.7; 4.8; 5.1; 6.3; 6.4; 6.5; 6.6; 6.7; 6.8; 7; 8;
9.1; 9.2; 9.4; 9.5; 9.6; 9.7; 9.9; 9.10; 9.11; 9.12; and 9.13. |
Section
5
Intellectual
Property Rights
5.1
Rights in Improvements and Improvement Patents.
| a. | Background
IP. The Parties acknowledge that each enters this Agreement having its own Intellectual
Property that is independent of this Agreement. Nothing in this Agreement should affect,
or is intended to affect, Licensor’s ownership or control of Licensor Background IP
or Licensee’s ownership or control of Licensee Background IP |
| b. | Except
as otherwise set forth in this Section 5, any Intellectual Property (including Sublicensee
Improvements and Sublicensee Improvement Patents) developed during the term of this Agreement
by or on behalf of a Party or Sublicensee shall be owned by the Party or Parties or Sublicensee
whose employee(s), contractor(s), or agents would be deemed to be the inventor(s) under U.S.
patent laws. |
| | |
| i. | Subject
to the licenses granted to Licensee under Sections 2.1 and 2.2 of this Agreement, Licensor
shall be the sole owner of all right, title, and interest in and to all Party Improvements
and Party Improvement Patents, including, without limitation, all related certificates of
correction, reissue certificates, and supplementary protection certificates, and all other
rights granted under 35 U.S.C. § 307, 35 U.S.C. § 318, 35 U.S.C. § 328, and
35 U.S.C. § 254-257. |
| ii. | Licensee
shall assign and hereby does assign (and shall ensure that all of its Affiliates assign),
to Licensor all right, title and interest in and to all Party Improvements and Party Improvement
Patents. Licensee shall execute and assist (and ensure that its Affiliates execute and assist)
with any and all applications, assignments, or other instruments which Licensor deems necessary
to perfect the foregoing assignment and/or to evidence, apply for, obtain, maintain, defend
or enforce Patent or other Intellectual Property protection in any and all countries worldwide
with respect to Party Improvements and Party Improvement Patents assigned to Licensor as
set forth above or to protect otherwise Licensor’s interest therein. |
| c. | If
either Party (directly or through its personnel) creates or discovers any Party Improvement,
then such Party shall promptly provide the other Party with written notice describing such
Party Improvement in reasonable detail (each such notice, an “Improvement Notice”).
Any Party Improvements developed solely by Licensor shall automatically be included in the
Licensed Patents and Licensor Know-How under the license granted in Section 2.1 and added
by the Parties to Exhibits D and B, respectively. Any Party Improvements that are not developed
solely by Licensor shall automatically be included in the license granted in Section 2.2
and added by the Parties to Exhibit F. Upon written request by either Party from time to
time, Licensee and Licensor agree promptly to update (a) Exhibit B and Exhibit D of this
Agreement, respectively, to reflect the inclusion of (i) Know-How included in Party Improvements
to the extent developed solely by Licensor and (ii) Party Improvement Patents to the extent
developed solely by Licensor and (b) Exhibit F to reflect (i) Know-How included in Party
Improvements to the extent developed solely by Licensee or jointly by Licensee and Licensor
and (ii) Party Improvement Patents to the extent developed solely by Licensee or jointly
by Licensee and Licensor. |
5.2 | Third-Party
Infringement and Claims of Infringement. Each of the Parties shall promptly, but in any
event no later than thirty (30) days after receipt of notice thereof, notify the other Party
in writing in the event of any claims by a Third Party of alleged patent infringement by
either Party or Affiliates or sublicensees or subcontractors with respect to the manufacture,
use, sale, offer for sale or importation of, as applicable, the Licensed Products (each,
an “Infringement Claim”). Any such Infringement Claim shall be
handled as follows: |
| a. | Subject
to, and without limiting Licensee’s indemnification obligations under this Agreement,
in the case of any Infringement Claim against only the Licensee, or against both Licensee
and Licensor, in each with respect to the Licensed Products, Licensee shall be deemed to
be the “Controlling Party” for purposes of such Infringement Claim. |
| b. | Subject
to, and without limiting Licensee’s indemnification obligations under this Agreement,
if such Infringement Claim is alleged or commenced solely against Licensor, then Licensor
shall be deemed to be the “Controlling Party” for purposes of such
Infringement Claim provided, however, that Licensor will not be obligated to enter
into negotiations with such Third Party to obtain rights for Licensee under the applicable
Patent. |
| c. | The
other Party (“non-Controlling Party”)shall reasonably assist the Controlling
Party in its role as the Controlling Party; |
| d. | The
Controlling Party shall assume control of the defense of such infringement claim, including
the selection of counsel. The non-Controlling Party, upon request of the Controlling Party,
agrees to join in any such litigation at the Controlling Party’s expense, and in any
event to reasonably cooperate with the Controlling Party at the Controlling Party’s
expense. The non-Controlling Party will have the right to consult with the Controlling Party
concerning such infringement claim and to participate in and be represented by independent
counsel in any litigation in which such non-Controlling Party is a party at its own expense.
The Controlling Party shall have the exclusive right to settle any Infringement Claim without
the consent of the other Party, unless such settlement may reasonably be expected to have
a material adverse impact on the other Party (in which case the consent of such other Party
shall be required, such consent not to be unreasonably withheld). Without limiting the foregoing,
for purposes of this Section 5.2, any settlement that would involve the waiver of rights
(including the rights to receive payments) of such other Party shall be deemed a material
adverse impact and shall require the consent of such other Party, such consent not to be
unreasonably withheld. |
| e. | If
a Party shall become engaged in or participate in any suit described in this Section, the
other Party shall cooperate, and shall cause its and its Affiliates’ employees to cooperate,
with such Party in all reasonable respects in connection therewith, including giving testimony
and producing documents lawfully requested, and using its reasonable efforts to make available
to the other, at no cost to the other (other than reimbursement of actually incurred, reasonable
out-of-pocket travel and lodging expenses), such employees who may be helpful with respect
to such suit, investigation, claim, or other proceeding. |
5.3.
Enforcement of Licensed Patents against Third Party infringement shall be subject to the following:
| a. | If
either Party becomes aware of any infringement by a Third Party of any Licensed Patent in
the Field anywhere in the Territory (“Third Party Infringement”),
then such Party will notify the other Party in writing within thirty (30) days to that effect. |
| b. | Licensor
will have the first right (but not the obligation) to take the appropriate steps to enforce
or defend any Licensed Patent against Third Party Infringement, and may take steps including
the initiation, prosecution, and control of any suit, proceeding, or other legal action by
counsel of its own choice. Licensor shall bear the costs of such enforcement or defense,
as applicable. Notwithstanding the foregoing, Licensee will have the right, at its own expense,
to be represented in any such action by counsel of its own choice. |
| c. | In
the event that Licensor does not choose to enforce against Third Party Infringement within
180 days of notice of such infringement, Licensee shall have the right (but not the obligation)
to take the appropriate steps to enforce or defend any Licensed Patent against infringement
by a Third Party, and may take steps including the initiation, prosecution, and control of
any suit, proceeding, or other legal action by counsel of its own choice. Licensee shall
bear the costs of such enforcement or defense, as applicable. Notwithstanding the foregoing,
Licensor will have the right, at its own expense, to be represented in any such action by
counsel of its own choice. |
| d. | If
one Party brings any suit, action or proceeding under this Section, the other Party agrees
to be joined as party plaintiff if necessary to prosecute the suit, action, or proceeding
and to give the first Party reasonable authority to file and prosecute the suit, action,
or proceeding; provided, however, that neither Party will be required to transfer any right,
title, or interest in or to any property to the other Party or any other party to confer
standing on a Party hereunder. |
| e. | The
Party not pursuing the suit, action, or proceeding hereunder will provide reasonable assistance
to the other Party, including by providing access to relevant documents and other evidence
and making its employees available, subject to the other Party’s reimbursement of any
Out-of-Pocket Costs incurred by the non-enforcing or defending Party in providing such assistance. |
| f. | Licensee
shall not, without the prior written consent of Licensor (in its sole discretion), enter
into any compromise or settlement relating to any claim, suit, or action that it brought
under this Section that admits the invalidity or unenforceability of any Licensed Patent,
or requires Licensor to pay any sum of money, or otherwise adversely affects the rights of
Licensor with respect to such Licensed Patents, the Licensed Products, or Licensor’s
rights hereunder (including the rights to receive payments). |
| g. | Any
settlements, damages or other monetary awards (a Recovery) recovered pursuant to a suit,
action, or proceeding brought pursuant to this Section will be allocated first to the costs
and expenses (including attorney’s fees) of the Parties, and the remainder, if any,
will (i) in the event that Licensor enforces or defends the Third Party Infringement, be
allocated to Licensor, and (ii) in the event Licensee enforces or defends the Third Party
Infringement, be considered Sublicense Fees and shared between Licensee and Licensor in accordance
with Exhibit A. |
5.4.
Patent Prosecution. As between the Parties, Licensor shall be responsible for preparing, filing, prosecuting, and maintaining
all patent applications and patents included in the Licensed Patents in the Territory. Licensor shall not abandon any Licensed Patent
that has issued on or before the Effective Date without prior written approval of Licensee. With respect to Licensed Patents that have
not issued on or before the Effective Date, if Licensor elects to abandon any such Licensed Patent, it will (a) provide Licensee with
ten (10) business days’ prior written notice of its intent to abandon such Licensed Patent and (b) consider in good faith any comments
Licensee may provide regarding such proposed abandonment. Licensor shall select patent counsel to conduct such activities regarding the
Licensed Patents, shall keep Licensee reasonably informed of prosecution activities for Licensed Patents, and shall provide Licensee
an opportunity to provide comments, which Licensor will consider in good faith. During the first nine (9) months of the Initial Term,
Licensor shall participate in monthly meetings with Licensee and Licensor’s selected patent counsel to discuss patent prosecution
activities and decisions with respect to the Licensed Patents. With the sole exception of the payments identified in Exhibit A, all Licensed
Patent expenses shall be borne by Licensor.
Section
6
Warranties,
Representations, Disclaimers, and Indemnities
6.1
Each Party (“Representing Party”) hereby represents, warrants and covenants to the other Party that:
| a. | As
of the Effective Date, the execution and performance of the Representing Party’s obligations
under this Agreement do not conflict with, cause a default under, or result in a breach of
or violate any existing contractual obligation that may be owed by the Representing Party
to any Affiliate or Third Party, nor will the Representing Party, during the Term of this
Agreement, take any action, inaction or enter into agreement that would conflict with, cause
a default under, result in a breach of or violate (i) any existing contractual obligation
that is owed to the other Party under this Agreement or (ii) with respect to Licensee, the
terms of the Existing License Agreements; |
| b. | The
Representing Party has full power and authority to execute, deliver and perform this Agreement
and that this Agreement constitutes the legally binding and valid obligation of The Representing
Party, enforceable in accordance with its terms, except as such enforcement may be limited
by applicable bankruptcy, moratorium and other laws affecting creditors’ rights generally; |
| c. | As
of the Effective Date, there is no action or suit pending against the Representing Party
or any of its Affiliates that questions the validity of this Agreement or the right of the
Representing Party to enter into this Agreement or consummate the transactions contemplated
hereby, and neither the Representing Party nor any of its Affiliates is a party to any litigation,
arbitration, mediation or other similar legal proceeding relating to the activities contemplated
by this Agreement; and |
| d. | As
of the Effective Date, the Representing Party is not in breach of this Agreement and to its
knowledge, the other Party is not in breach of this Agreement. |
6.2
Licensor makes the following warranties and representations to Licensee as of the Effective Date:
| a. | Licensor
is the owner or licensee of the Licensed Patents and/or has the right to grant rights, licenses,
privileges, releases, non-assertions, and immunities under or relating to the Licensed Patents. |
| b. | There
are no liens, conveyances, mortgages, assignments, encumbrances, other licenses, or other
agreements (other than the Existing License Agreements) which would prevent or impair the
full and complete exercise of the rights, licenses, privileges, releases, non-assertions,
and immunities granted by Licensor to Licensee, its respective successors and assigns, customers,
whether immediate or remote, and suppliers with respect to the Licensed Patents pursuant
to the specific terms and conditions of this Agreement. |
| c. | Licensor
is not aware of any reason that the Licensed Patents are invalid, however, nothing herein
contained shall be construed as a warranty by Licensor that the Licensed Patents are valid. |
| d. | Except
as previously disclosed to Licensee, Licensor is not aware of any reason that the inventions
claimed or covered by the Licensed Patents would be deemed: (i) as having been conceived,
discovered, developed or otherwise made in connection with any research activities funded,
in whole or in part, by the federal government of the United States of America or any agency
thereof; (ii) a “subject invention” as that term is described in 35 U.S.C. Section
201(e) and (iii) otherwise subject to the provisions of the Patent and Trademark Law Amendments
Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well
as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401 (the “Bayh-Dole
Act”). |
6.3
Except as expressly provided in Section 6.1 or Section 6.2, nothing in this Agreement will be construed as (a) a warranty or representation
by Licensor as to the validity or scope of any of the Licensed Patents, (b) a warranty or representation by Licensor that anything made,
used, sold or otherwise disposed of under the licenses granted in this Agreement, or the practice of the Licensed Patents or Licensor
Know-How will or will not infringe Patents or other Intellectual Property of Third Parties, or (c) an obligation of Licensor to bring
or prosecute actions or suits against Third Parties for infringement of Licensed Patents.
6.4
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, LICENSOR IS PROVIDING THE LICENSED PATENTS AND LICENSOR KNOW-HOW “AS IS.”
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER LICENSOR NOR LICENSEE MAKES ANY REPRESENTATIONS, EXTENDS ANY WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT OR AS TO THE VALIDITY OF ANY PATENTS, AND LICENSOR DOES NOT ASSUME ANY RESPONSIBILITY WHATSOEVER WITH RESPECT
TO USE, SALE, OR OTHER DISPOSITION OF PRODUCTS INCORPORATING OR MADE BY USE OF THE LICENSED PATENTS OR LICENSOR KNOW-HOW IN CONNECTION
WITH THIS AGREEMENT.
6.5
Indemnification by Licensee.
| a. | Licensee
will indemnify, defend and hold harmless Licensor, its Affiliates and their respective directors,
officers, employees, consultants, and agents, and their respective successors, heirs, and
assigns (each a “Licensor Indemnitee”), against all Third Party
suits, actions, claims, proceedings, liabilities, demands, damages, losses, or expenses (including
legal expenses, investigative expenses, and reasonable attorneys’ fees), including
claims resulting from or connected to the death of or injury to any person or persons, or
any damage to property, resulting from, arising out of, or otherwise attributable to Licensee’s
or, as applicable Licensee’s Affiliate’s or Sublicensee’s: (i) negligence
or misconduct in connection with this Agreement, (ii) failure to materially comply with Applicable
Laws or the terms of this Agreement, including any material breach of Licensee’s express
representations and warranties set forth in this Agreement, or (iii) Exploitation of Licensed
Products or the exercise of the licenses granted under this Agreement, including the sublicensing,
production, manufacture, sale, use, lease, consumption, administration, shipping, storage,
transfer, advertisement of the Licensed Patents, Licensor Know-How, or Licensed Products,
or any activity arising from or in connection with any right or obligation of Licensee hereunder,
except in each case to the extent resulting from, arising out of, or otherwise attributable
to Licensor’s failure to comply with Applicable Laws or the terms of this Agreement. |
| b. | Licensor
will promptly give notice to Licensee of any suits, actions, claims, proceedings, liabilities,
demands, damages, losses, or expenses which might be covered by this Section 6.5 and Licensee
will have the right to defend the same, including selection of counsel and control of the
proceedings; provided that Licensee will not, without the written consent of Licensor, settle
or consent to the entry of any judgment with respect to any such Third Party claim (i) that
does not release the applicable Licensor Indemnitee(s) from all liability with respect to
such Third Party claim or (ii) which may materially adversely affect Licensor or the Licensor
Indemnitees or under which Licensor or the applicable Licensor Indemnitee(s) would incur
any obligation or liability, other than one as to which Licensee has an indemnity obligation
hereunder. Licensor agrees to fully cooperate and aid such defense. Licensor at all times
reserves the right to select and retain counsel of its own at its own expense to defend Licensor’s
interests. |
6.6
Indemnification by Licensor.
| a. | Licensor
will indemnify, defend and hold harmless Licensee, its Affiliates and their respective directors,
officers, employees, consultants, and agents, and their respective successors, and assigns
(each a “Licensee Indemnitee”), against all Third Party suits,
actions, claims, proceedings, liabilities, demands, damages, losses, or expenses (including
legal expenses, investigative expenses, and reasonable attorneys’ fees) resulting from,
arising out of, or otherwise attributable to Licensor’s (i) negligence or misconduct
in connection with this Agreement, or (ii) failure to materially comply with Applicable Laws
or the terms of this Agreement, including any material breach of Licensor’s express
representations and warranties set forth in this Agreement, except to the extent resulting
from, arising out of, or otherwise attributable to Licensee’s failure to comply with
Applicable Laws or the terms of this Agreement. |
| b. | Licensee
will promptly give notice to Licensor of any suits, actions, claims, proceedings, liabilities,
demands, damages, losses, or expenses which might be covered by this Section 6.6 and Licensor
will have the right to defend the same, including selection of counsel and control of the
proceedings; provided that Licensor will not, without the written consent of Licensee, settle
or consent to the entry of any judgment with respect to any such Third Party claim (i) that
does not release the Licensee Indemnitee(s) from all liability with respect to such Third
Party claim or (ii) which may materially adversely affect Licensee or the Licensee Indemnitee
or under which Licensee or the applicable Licensee Indemnitee would incur any obligation
or liability, other than one as to which Licensor has an indemnity obligation hereunder.
Licensee agrees to fully cooperate and aid such defense. Licensee at all times reserves the
right to select and retain counsel of its own at its own expense to defend Licensee’s
interests. |
6.7
TO THE FULLEST EXTENT PERMITTED BY LAW, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON FOR ANY INJURY TO OR LOSS
OF GOODWILL, REPUTATION, BUSINESS PRODUCTION, REVENUES, PROFITS, ANTICIPATED PROFITS, CONTRACTS, OR OPPORTUNITIES (REGARDLESS OF HOW
THESE ARE CLASSIFIED AS DAMAGES), OR FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, PUNITIVE, OR ENHANCED DAMAGES,
WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY, OR OTHERWISE (INCLUDING
THE ENTRY INTO, PERFORMANCE, OR BREACH OF THIS AGREEMENT), REGARDLESS OF WHETHER SUCH LOSS OR DAMAGE WAS FORESEEABLE AND THE PARTY AGAINST
WHOM LIABILITY IS CLAIMED HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED REMEDY
OF ITS ESSENTIAL PURPOSE. THE FOREGOING LIMITATIONS WILL NOT: (A) APPLY TO INFRINGEMENT BY A PARTY OF THE OTHER PARTY’S INTELLECTUAL
PROPERTY RIGHTS OR A PARTY’S BREACH OF SECTIONS 7 OR 9.9, OR (B) LIMIT A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER THIS SECTION
6.
6.8
Both Parties shall maintain in full force and effect during the Term and for a period of three (3) years after expiration or termination
of this Agreement, worker’s compensation, general liability and professional liability, clinical trial liability, and product liability
insurance coverage, all in such amounts and with such scope of coverages as are reasonably sufficient to cover its respective obligations
under this Agreement and as are customary in the life sciences and pharmaceutical industries. Upon written request of a Party, the other
Party, shall provide evidence of such insurance to the requesting Party. Each Party shall be named as an additional insured with respect
to such insurance policies held by the other Party, and each Party shall ensure that the other Party will receive no less than fourteen
(14) days’ prior notice of any cancelation, non-renewal or material change in such insurance coverage.
Section
7
Confidentiality
and Publicity
7.1
Confidential Information. Each Party shall maintain the Confidential Information of the other Party in strict confidence, and
will not disclose, divulge or otherwise communicate such Confidential Information to others, or use it for any purpose, except pursuant
to, and in order to carry out, the terms and objectives of this Agreement, or with the express written consent of the Party who provided
such Confidential Information. Each Party will maintain the confidentiality of the other Party’s Confidential Information using
methods and practices that are substantially similar to those that the receiving Party uses to maintain the confidentiality of its own
confidential information, but in no event less than a reasonable degree of care. Except as may be authorized in advance in writing by
the disclosing Party, the receiving Party will only grant access to the Confidential Information to its employees and agents as necessary
to carry out activities under this Agreement and such employees and agents will have entered into non-disclosure agreements consistent
with the terms of this Section 7.1. The obligations of confidentiality described above will not pertain to that part of any Confidential
Information to the extent that it is supported by competent written proof that:
| a. | such
information was lawfully in the receiving Party’s possession or control prior to the
time it received the information from the disclosing Party (except to the extent received
in confidence under the Original Agreement); |
| b. | such
information was developed by the receiving Party independently of and without reference to
the Confidential Information of the disclosing Party; |
| c. | such
information was, at the time it was disclosed to or obtained by the receiving Party, or thereafter
became, available to the public through no act or omission of the Party holding such information;
or |
| d. | such
information was lawfully obtained by the receiving Party from a Third Party that has the
right to disclose such information free of any obligations of confidentiality. |
In
addition, a receiving Party may disclose such Confidential Information to the limited extent required to do so by Applicable Law or a
proper legal, governmental or other competent authority, or by the rules of any securities exchange on which any security issued by either
Party is traded, or included in any filing or action taken by the receiving Party to obtain or maintain government clearance or approval
to market a subject Licensed Product. Except where impracticable, such required Party shall give the other Party reasonable advance notice
of such disclosure requirement and shall afford the other Party a reasonable opportunity to oppose, limit or secure confidential treatment
for such required disclosure, or, where it is impracticable to give an advance notice, such required Party shall give the other Party
reasonable notice promptly after such required disclosure. In the event of any such required disclosure, the required Party shall disclose
only that portion of the Confidential Information legally required to be disclosed.
In
addition, either Party may disclose Confidential Information, including this Agreement, and the terms hereof (including providing a copy
hereof, redacted as appropriate) to any bona fide potential licensor, licensee, partner or permitted Sublicensee or successor to said
Party’s interest under this Agreement, to a bona fide potential lender from which said Party is considering borrowing money, to
a bona fide potential collaborator in connection with development or commercialization of Licensed Products, to any bona fide financial
investor from which said Party may take money, to any insurance broker, business, financial or scientific consultants, attorneys, and
accountants; provided, however, in any such case said Party shall first obtain a written obligation of confidentiality, non-disclosure
and non-use no less stringent than those imposed in this Section 7.1 (or in the case of attorneys or other professionals, an equivalent
professional duty of confidentiality) from the bona fide potential licensor, licensee, partner, permitted Sublicensee or successor, bona
fide potential lender, bona fide potential collaborator, bona fide financial investor, insurance broker, business, financial or scientific
consultant, attorney or accountant.
7.2
Use of Names. Neither Party may identify the other Party in any promotional advertising or other promotional materials to be disseminated
to the public or any portion thereof, or use the name of any staff member or employee of the other Party or any trademark, service mark,
trade name, symbol or logo that is associated with the other Party, without the other Party’s prior written consent. Notwithstanding
the foregoing, and for the avoidance of doubt, without the consent of the other Party either Party may comply with disclosure requirements
of all Applicable Laws relating to its business, including United States and state securities laws. Each Party may include the other
Party’s name, logo, and a brief description of such other Party on said Party’s website.
7.3
Press Releases. The Parties shall mutually agree upon the timing and content of any press releases or other public announcement
relating to this Agreement and the transactions contemplated herein, provided, however, that either Party or its Affiliates may disclose
the relevant terms of this Agreement to the extent required to comply with the rules and regulations promulgated by the U.S. Securities
and Exchange Commission or any equivalent governmental agency or Applicable Law in any country in the Territory, provided that such Party
shall use reasonable efforts to redact sensitive information and shall submit a confidential treatment request in connection therewith,
after consultation with the other Party.
Section
8
Dispute
Resolution
8.1
In the event of any dispute or disagreement between Licensor and Licensee as to the interpretation of any provision of this Agreement
or any other related document (or the performance of any obligations hereunder or thereunder), the matter, upon written request of either
Licensor or Licensee, shall be referred to representatives of Licensor and Licensee for decision, each such Party being represented by
an Executive Officer (the “Representatives”). The Representatives shall promptly meet and use good faith efforts
to resolve the dispute. If the Representatives do not mutually agree upon a decision within thirty (30) calendar days (as extended by
the last sentence of this Section 8.1) after reference of the matter to them, the Parties shall submit to mediation by a single independent
mediator, with expertise and experience applicable to the subject matter of the dispute, mutually agreeable to the Parties and in accordance
with procedures as may be mutually agreed in writing by the Parties. If the dispute is not resolved pursuant to such mediation (including
if the Parties are unable to mutually agree on the selection of a mediator or the relevant procedures for such mediation), then each
of the Licensor and Licensee shall be free to exercise the remedies available to it under Section 8.2. Each of the Licensor and Licensee
may extend the period of time for negotiation among the Representatives for an additional period of thirty (30) calendar days on one
(1) occasion per dispute.
8.2
If the Licensor and Licensee are unable to resolve such dispute pursuant to Section 8.1, the dispute shall be submitted to binding arbitration
(without any recourse to the federal or state courts except to enforce any arbitral award or, within forty five (45) days of an Arbitrator’s
rendering of a final decision, to appeal such final decision based solely on a claim that the Arbitrator engaged in gross misconduct
or made a material error or miscalculation in his or her decision) in accordance with the rules of JAMS (“JAMS”)
then in force (except as expressly modified below), and the arbitration hearings shall be held before a single arbitrator (“Arbitrator”)
in Boston, Massachusetts. The Licensor and Licensee agree to appoint an Arbitrator who is knowledgeable in the biotechnology and/or life
sciences industries. If the Licensor and Licensee cannot agree upon an Arbitrator within ten (10) days after a demand for arbitration
has been filed with the JAMS by either of them, either or both of the participating Licensor and Licensee may request the JAMS to name
a panel of five (5) candidates to serve as Arbitrator. The participating Licensor and Licensee shall each, in successive rounds (with
the Party demanding the arbitration having the first chance to strike a name), strike one name off this list until only one name remains,
and such last-named person shall be the Arbitrator. In the event that the dispute involves a claim of more than $5,000,000, then instead
of one Arbitrator, there shall be three (3) Arbitrators who are knowledgeable in the biotechnology and/or life sciences industries, with
each Party selecting one (1) Arbitrator and the two (2) Arbitrators so chosen, shall select a third arbitrator, who shall serve as the
chair of the arbitration panel.
8.3
The Arbitrator shall be required to (a) follow the substantive rules of the Commonwealth of Massachusetts and Federal law, as applicable,
(b) have all testimony be transcribed, and (c) accompany his or her award with findings of fact and a statement of reasons for the decision.
The Arbitrator(s) shall have the authority to permit discovery for no more than thirty (30) days, to the extent deemed appropriate by
the Arbitrator(s), upon reasonable request of a participating Party. The Arbitrator(s) shall have no power or authority to (i) add to
or detract from the written agreement of the Parties set forth herein, (ii) modify or disregard any provision of this Agreement or any
of the other related documents, or (iii) address or resolve any issue not submitted by the Parties. The Arbitrator(s) shall hold proceedings
during a period of no longer than thirty (30) calendar days promptly following conclusion of discovery, and the Arbitrator(s) shall render
a final decision within thirty (30) days following conclusion of the hearings. The Arbitrator(s) shall have the power to grant injunctive
relief (without the necessity of a Party posting a bond) in the event a Party has violated the confidentiality provisions set forth in
this Agreement, but shall have no power to award punitive and/or exemplary damages in the event of a breach. In the event of any conflict
between the commercial arbitration rules then in effect and the provisions of this Agreement, the provisions of this Agreement shall
prevail and be controlling.
8.4
Either Licensor or Licensee may, without waiving any remedy under this Agreement, apply to the Arbitrator(s) for interim injunctive relief
until the arbitration award is rendered or the controversy is otherwise resolved. Either Licensor or Licensee also may, without waiving
any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the
rights regarding the Intellectual Property or Confidential Information of that Party pending the arbitration award. The Arbitrator(s)
shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages.
8.5
Licensor and Licensee shall share in the actual and direct costs of the engagement of the Arbitrator, but the prevailing Party(ies) in
the arbitration shall be reimbursed by the non-prevailing Party(ies) for the prevailing Party’s fees and costs of arbitration (e.g.,
the costs, fees and expenses of outside experts and counsel retained by the prevailing Party). If Licensor or Licensee is not deemed
by the Arbitrator to be the primary prevailing Party, then each Party will pay its own costs, fees and expenses (including attorneys’
fees) and an equal share of the Arbitrator(s)’ fees and any administrative fees of arbitration.
8.6
Unless otherwise mutually agreed upon by the Parties in writing, any Excluded Claims may be brought in the federal court located in the
District of Massachusetts, if federal jurisdiction is available, or, alternatively, in the state courts in Boston, Massachusetts. Each
of the Parties hereby submits to the jurisdiction of such courts for the purpose of any such litigation; provided, however,
that a final judgment in any such litigation shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or
in any other manner provided by law. Each Party irrevocably and unconditionally agrees not to assert (a) any objection which it may ever
have to the laying of venue of any such litigation in such courts, (b) any claim that any such litigation brought in any such court has
been brought in an inconvenient forum, and (c) any claim that such court does not have jurisdiction with respect to such litigation.
As used in this Section 10.6, the term “Excluded Claim” means a dispute, controversy or claim that concerns:
(x) the scope, construction, validity or infringement of a Patent or copyright; or (y) any antitrust, antimonopoly or competition law
or regulation, whether or not statutory; or (z) Licensee’s or, as applicable, Licensee’s Affiliates or Sublicensee(s), Exploitation
of Licensed Products or use of the Licensed Patents or Licensor Know-How in any manner that is not expressly authorized under this Agreement.
8.7
Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an Arbitrator may disclose the existence,
content, or results of the arbitration without the prior written consent of the other Parties, except to its directors and officers,
subject to the exceptions for other Confidential Information as set forth in Section 7.
8.8
In no event shall arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute,
controversy or claim would be barred by the applicable Commonwealth of Massachusetts statute of limitations.
Section
9
Other
Provisions
9.1
If any of the provisions of this Agreement shall contravene the laws of any country, it is agreed that such invalidity or illegality
shall not invalidate this Agreement, but instead this Agreement shall be construed as if it did not contain the provision(s) claimed
or held to be invalid or illegal in the particular jurisdiction concerned, insofar as such construction does not materially affect the
substance of this Agreement, and the rights and obligations of the parties hereto shall be construed and enforced accordingly. In the
event, however, that such claimed invalidity or illegality shall substantially alter the relationship between the parties hereto, materially
affecting adversely the interest of either party in such jurisdiction, then the parties hereto shall negotiate an alternative provision
not conflicting with such laws so as to maintain, to the degree reasonably possible, the business and economic benefits and liabilities
as initially set forth herein.
9.2
This Agreement sets forth the entire understanding of the parties relating to the subject matter hereof and cancels and supersedes all
other agreements or understandings leading up to the execution of this Agreement, except as expressly stated otherwise. Without limiting
the foregoing, as of the Effective Date, the Parties hereby terminate the Original Agreement in its entirety except that (a) all payment
obligations that have accrued under the Original Agreement but that remain unpaid by Licensee as of the Effective Data (i) shall survive
and be deemed payment obligations under this Agreement, and (ii) Licensee shall pay Licensor all such accrued amounts no later than ten
(10) days following the Effective Date and (b) Sections 1, 2.4, 3.4, 5.1-5.3, 6.3-6.5, 8.1 (with respect to Improvements and Improvement
Patents (as defined in the Original Agreement) that were created or discovered on or before March 31, 2024), 8.6, 9.1-9.2, 10, and 11of
the Original Agreement shall survive such termination and apply to the activities of the Parties under the Original Agreement prior to
the Effective Date. For the avoidance of doubt, ownership of Party Improvements and Party Improvement Patents that were created or discovered
on or following April 1, 2024 shall be determined in accordance with Section 5.1 of this Agreement. The Parties acknowledge and agree
that the Original Agreement amended and restated in its entirety the Prior Agreement (as such term is defined in the Original Agreement).
The Parties further acknowledge and agree that, notwithstanding any provision of this Agreement to the contrary, the Exacis Agreement
is hereby terminated as of the Effective Date. No amendment or modification of this Agreement shall be valid or binding upon the parties
unless made in writing and signed on behalf of the parties by their respective duly authorized representatives. In the event of any conflict
between the terms and provisions of this Agreement and those of any Exhibit or other document, the following order of precedence will
govern: (a) first, this Agreement, excluding its Exhibits; (b) second, the Exhibits to this Agreement as of the Effective Date; and (c)
third, any other documents incorporated herein by reference.
9.
3 In the event of a transfer or assignment of one or more of the Licensed Patents by Licensor, the assignee thereof shall take such assignment
subject to the rights, licenses, privileges, releases, non-assertions, and immunities granted under this Agreement. This Agreement will
be binding upon and will inure to the benefit of each Party and each Party’s respective transferees, successors and assigns, pursuant
to the provisions set forth below. Neither Party may transfer or assign this Agreement (i) without the prior written consent of the other
Party, provided that if such transfer or assignment is to an Affiliate of such Party, such consent shall not be unreasonably withheld,
conditioned or delayed, or (ii) as otherwise provided in this Section 9.3. In the event that a Third Party (the “Acquiring
Party”) acquires all or substantially all of a Party’s business, capital stock or assets, whether by sale, merger,
change of control, operation of law or otherwise (an “Acquisition”), the rights granted to such Party under
this Agreement shall inure to the benefit of the Acquiring Party. For the avoidance of doubt, in the event of an Acquisition, the Acquiring
Party will be responsible for all payments and other obligations set forth in this Agreement, including, but not limited to, all payments
set forth herein, and any obligations that matured prior to the Acquisition date. Upon an Acquisition, payment thereof shall remain an
ongoing obligation of the Acquiring Party until such amount is paid in full. Any attempted assignment in contravention of this Section
9.3 will be null and void.
9.4
No act, delay, or omission by any party shall be deemed a waiver of any right, power, or remedy of such party unless such waiver is in
writing, and then only to the extent set forth therein. All remedies, either under this Agreement or by law or otherwise afforded to
a party, shall be cumulative and not alternative. No waiver of any provision, right or remedy under this Agreement on any one occasion
shall constitute a waiver of any other provision, right, or remedy on said occasion or the same or any other provision, right, or remedy
on any other occasion.
9.5
This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together
shall constitute one and the same instrument.
9.6
All rights, licenses, privileges, releases, non-assertions, and immunities granted under or pursuant to this Agreement by Licensor to
Licensee are, and shall otherwise be deemed to be, for the purpose of Section 365(n) of the United States Bankruptcy Code, as amended
(“the Bankruptcy Code”), licenses of rights to “intellectual property” as defined under Section 101 (35A) of
the Bankruptcy Code. The parties hereto agree that Licensee, as licensee of such rights under this Agreement, shall retain and may fully
exercise all of their rights and elections under the Bankruptcy Code. The parties hereto further agree that, if a Bankruptcy Code case
is commenced by or against Licensor and this Agreement is rejected as provided in the Bankruptcy Code, then Licensor (in any capacity,
including debtor-in-possession) and their successors and assigns (including, without limitation, a Bankruptcy Code trustee) shall take
such steps as are necessary to permit Licensee to exercise all of their rights under this Agreement. All rights, powers, and remedies
of Licensee provided under this Section are in addition to and not in substitution for any and all other rights, powers, and remedies
now or hereafter existing at law or in equity (including, without limitation, the Bankruptcy Code) in the event of any such commencement
of a bankruptcy proceeding by or against Licensor. Licensee, in addition to the rights, powers and remedies expressly provided herein,
shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at
law or in equity (including the Bankruptcy Code) in such event.
9.7
Any notice required to be given pursuant to the provisions of this Agreement will be in writing and will be deemed to have been given
at the time when actually received as a consequence of any effective method of delivery, including but not limited to hand delivery,
or electronic transmission, including PDF (portable document format), delivery by a professional courier service or delivery by first
class, certified or registered mail (postage prepaid) addressed to the Party for whom intended at the address below, or at such changed
address as the Party will have specified by written notice in accordance with this Section 9.6; provided, however, that any notice
of change of address will be effective only upon actual receipt.
If
to Licensor:
Factor
Bioscience Limited
c/o
Factor Bioscience Inc.
Attn:
Matt Angel, Chief Executive Officer
1035
Cambridge Street, Suite 17B
Cambridge,
MA 02141
Matt.angel@factorbio.com
With
copy to which shall not constitute notice:
Wilson
Sonsini Goodrich & Rosati PC
Attn:
Mark W. Bellomy
One
Boston Place
201
Washington Street, Ste. 2000
Boston,
MA 02108
mbellomy@wsgr.com
If
to Licensee:
Eterna
Therapeutics, Inc.
Attn:
Sanjeev Luther, President & Chief Executive Officer
1035
Cambridge Street, Suite 18A
Cambridge
MA 02141
Sanjeev.luther@eternatx.com
With
copy to which shall not constitute notice:
Haug
Partners, LLP
Attn:
Edgar Haug
745
5th Avenue
New
York, NY 10151
ehaug@haugpartners.com
or
to such other address as the party to receive such notice shall have designated by written notice to the other party hereto.
9.8
During the Term, neither Licensor nor Licensee, without the prior written consent of the other Party, shall directly or indirectly solicit
for employment any employee of the other Party or any of its Affiliates, or any person who has terminated his or her employment with
the other Party or any of its Affiliates within the previous twelve (12)-month period prior to any purported solicitation; provided,
however, the foregoing will not prevent Licensor or Licensee from employing any such person who contacts such Party on his or
her own initiative without any direct or indirect solicitation by or encouragement from the soliciting or hiring person. General advertising
which is not directed at any specific employee of a Party will not be deemed solicitation, and hiring of employees of such Party which
are solicited in this manner will not be a breach of this provision.
9.9
Licensee on behalf of itself, its Affiliates and Sublicensees hereby covenants and agrees that it shall not make, write or publish any
statement, assertion or claim that disclaims, disparages, denies, questions or otherwise challenges or casts doubt upon the validity,
enforceability, scope, construction or inventorship of any Patent Controlled by Licensor (including, but not limited to, any pending
or issued claim(s) within the Licensed Patents). The provisions set forth in this Section 9.9 shall take effect on the Effective Date,
shall not require any further consideration or performance of Licensor, and shall survive the expiration or termination of this Agreement
for three (3) years from the date or expiration or termination of this Agreement. If any part of this Section 9.9 shall be deemed illegal
or unenforceable by a court of competent jurisdiction, that part shall be deemed automatically deleted (or modified to the minimum extent
deemed necessary by such court to make such provision enforceable and to give effect to the original intention of the Parties pursuant
to Section 9.1), such deletion being made as narrowly as possible (and, if possible, only in said jurisdiction) to maintain, as much
as possible, the intent of this Section 9.9, and the remainder of this Section 9.9 shall, with related definitions, remain in full force
and effect.
9.10 The
substantive law governing this Agreement (which shall be applied in the arbitration) shall be, with respect to disputes involving general
contract or trade secret matters, the internal laws of the Commonwealth of Massachusetts, and with respect to matters involving patents,
the United States Patent Act, and as to copyright matters, the United States Copyright Act, each as amended from time to time. Any award
rendered by the Arbitrator(s) shall be final, conclusive and binding upon the Parties to this Agreement, and judgment thereon may be
entered and enforced in any state or federal court of competent jurisdiction.
9.11
Licensor and Licensee are independent contractors under this Agreement. Nothing contained in this Agreement will be deemed to create
an employment, agency, joint venture or partnership relationship between the Parties hereto or any of their agents or employees, or any
other legal arrangement that would impose liability upon one Party for the act or failure to act of the other Party. Neither Party will
have any express or implied power to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf
of, the other Party, or to bind the other Party in any respect whatsoever.
9.12
No Preferential Treatment, Fraudulent Conveyance, Insolvency.
| a. | The
Parties have not entered into this Agreement to provide any preferential treatment under
section 547 of the Bankruptcy Code or any other applicable insolvency law. |
| b. | Neither
the execution or delivery of this Agreement or the consummation of the transactions hereunder
were entered into with the intent by either Party to effectuate a transaction that may be
avoided under section 548(a) of the Bankruptcy Code, the Uniform Fraudulent Transfer Act
(the “UFTA”), the Uniform Voidable Transactions Act (“UVTA”)
or any other applicable insolvency law. The Parties received reasonably equivalent value
in exchange for the obligations provided hereunder. The transactions contemplated hereunder
are not subject to avoidance under section 548(a) of the Bankruptcy Code, the UFTA, or any
applicable insolvency law. |
| c. | As
of the Effective Date, neither Party intends to file for protection or seek relief under
title 11 of the Bankruptcy Code or any similar federal or state law providing for the relief
of debtors. As of the Effective Date, neither Party is insolvent (as such term is defined
in the Bankruptcy Code or any other Applicable Law relating to insolvency). |
9.13
This Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party. Ambiguities, if any,
in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous
provision. Licensee hereby acknowledges that Licensor owns and/or has in-licensed the Licensed Patents and Licensor Know-How, and the
use of the term “license” hereunder with reference to the rights granted to Licensee is understood by the Parties to mean
either a direct license of Licensor’s ownership interest in the subject Licensed Patents or Licensor Know-How or a sublicense of
Licensor’s in-licensed interest in the subject Licensed Patents or Licensor Know-How, as applicable. The headings of each Section
in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the
language contained in the particular Section. Except where the context otherwise requires, the use of any gender shall be applicable
to all genders, and the word “or” is used in the inclusive sense (and/or). The term “including” as used herein
means including, without limiting the generality of any description preceding such term.
[Remainder
of page left blank intentionally.]
IN
WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
Factor Bioscience Limited |
|
|
|
|
By: |
/s/ Matt Angel |
|
Name: |
Matt Angel, PhD |
|
Title: |
Chief Executive Officer |
|
Eterna Therapeutics Inc. |
|
|
|
By: |
/s/ Sanjeev Luther |
|
Name: |
Sanjeev Luther |
|
Title: |
President and Chief Executive Officer. |
|
Exhibit
10.11
SUBLEASE
TERMINATION AGREEMENT
This
Sublease Termination Agreement (this “Agreement”) is dated as of August 9, 2024,
by and between E.R. SQUIBB & SONS, L.L.C., a Delaware limited liability company (“Sublessor”), and ETERNA THERAPEUTICS
INC., a Delaware corporation, (“Sublessee”).
R
E C I T A L S:
WHEREAS,
Sublessor and Sublessee entered into a Sublease Agreement dated the 18th day of October, 2022 (the “Sublease”),
whereby Sublessee subleased approximately 45,500 rentable square feet on the ninth (9th) floor of 250 Water Street, Cambridge
Crossing, Somerville, Massachusetts (the “Building”), more particularly described in the Sublease (the “Premises”).
WHEREAS,
Sublessor and Sublessee have agreed to terminate the Sublease on the terms and conditions provided below.
A
G R E E M E N T:
NOW,
THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is mutually acknowledged by the Sublessor and Sublessee,
the parties agree as follows:
1.
Recitals. The foregoing recitals are true and accurate and incorporated herein by reference.
2.
Termination of the Lease. Notwithstanding anything to the contrary contained in the Sublease, Sublessor and Sublessee hereby agree
that the Sublease shall terminate and be of no further force and both parties shall be released of any and all obligations thereunder
effective as of 11:59pm on August 31, 2024 (“Termination Date”).
3.
Surrender of the Premises. Sublessee hereby agrees to vacate the Premises and surrender and deliver exclusive possession of the
Premises to Sublessor on or before the Termination Date in accordance with the provisions of the Sublease.
4.
Furniture, Fixtures & Equipment. Effective as of the Termination Date, all of Sublessee’s right, title and interest
in all furniture, fixtures and laboratory equipment that are currently on the Premises (“FF&E”), listed on Exhibit
A attached hereto and made a part hereof, shall become the property of Sublessor.
5.
Representations and Warranties of Sublessee. Sublessee represents and warrants to Sublessor that
| (a) | Sublessee
has not heretofore assigned or sublet any portion of its interest in the Sublease; |
| (b) | no
other person, firm or entity has any right, title or interest in the Sublease; |
| (c) | Sublessee
has the full right, legal power and actual authority to enter into this Agreement and to
terminate the Sublease without the consent of any person, firm or entity; |
| (d) | Sublessee
has full right, title and interest in and to the FF&E, |
| (e) | the
FF&E is free and clear of any liens, outstanding balances due, amounts owed and claims
thereto, as documented in Exhibit B – Proof of Ownership, and |
| (f) | Sublessee
has the full right, legal power and actual authority to bind Sublessee to the terms and conditions
hereof. |
| (g) | Sublessee
further represents and warrants to Sublessor that as of the date hereof there are no, and
as of the Termination Date there shall not be any, mechanic’s liens or other liens
encumbering all or any portion of the Premises, by virtue of any act or omission on the part
of Sublessee, its predecessors, contractors, agents, employees, successors or assigns, as
documented in Exhibit C – Final Lien Waivers. Notwithstanding Section 1 above, the
representations and warranties set forth in this Section 4 shall survive the Termination
Date and Sublessee shall be liable to Sublessor for any inaccuracy or any breach thereof. |
6.
Governing Law. This Agreement shall be governed and construed under the laws of the Commonwealth of Massachusetts.
7.
Binding Effect. This Agreement shall inure to the benefit of, and shall be binding upon, the parties hereto and their respective
legal representatives, successors and assigns.
8.
Time is of the Essence. Time is of the essence of this Agreement and the provisions contained herein.
9.
Further Assurances. Sublessor and Sublessee hereby agree to execute such further documents or instruments as may be necessary
or appropriate to carry out the intention of this Agreement.
IN
WITNESS WHEREOF, Sublessor and Sublessee have executed this First Amendment as of the date first above written.
SUBLESSOR: |
E.R. SQUIBB & SONS, L.L.C., |
|
a Delaware limited liability company |
|
|
|
|
By: |
/s/ Mitchell Weitz |
|
Mitchell Weitz |
|
Vice President, Real Estate and Workplace Services |
SUBLESSEE: |
ETERNA THERAPEUTICS INC., |
|
A Delaware Corporation |
|
|
|
|
By: |
/s/ Dorothy Clarke |
|
|
|
Exhibit
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Sanjeev Luther, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Eterna Therapeutics Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal
control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
(a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
November 12, 2024 |
/s/
Sanjeev Luther |
|
Sanjeev
Luther |
|
President
and Chief Executive Officer |
|
(Principal
Executive Officer) |
Exhibit
31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Sandra Gurrola, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Eterna Therapeutics Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal
control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
(a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
November 12, 2024 |
/s/
Sandra Gurrola |
|
Senior
Sandra Gurrola |
|
Vice
President of Finance |
|
(Principal
Financial Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. 1350,
AS
ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of Eterna Therapeutics Inc. for the quarterly period ended September 30, 2024, as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned certifies, pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to his knowledge on the date hereof:
1.
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of Eterna Therapeutics Inc. for the period presented therein.
Date:
November 12, 2024 |
/s/
Sanjeev Luther |
|
Sanjeev
Luther |
|
President
and Chief Executive Officer |
|
(Principal
Executive Officer) |
The
foregoing certification is being furnished solely pursuant to 18 U.S.C. § 1350 and is not being filed as part of the Report or as
a separate disclosure document.
Exhibit
32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. 1350,
AS
ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of Eterna Therapeutics Inc. for the quarterly period ended September 30, 2024, as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned certifies, pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to her knowledge on the date hereof:
1.
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of Eterna Therapeutics Inc. for the period presented therein.
Date:
November 12, 2024 |
/s/
Sandra Gurrola |
|
Sandra
Gurrola |
|
Senior
Vice President of Finance |
|
(Principal
Financial Officer) |
The
foregoing certification is being furnished solely pursuant to 18 U.S.C. § 1350 and is not being filed as part of the Report or as
a separate disclosure document.
v3.24.3
Cover - $ / shares
|
9 Months Ended |
|
Sep. 30, 2024 |
Nov. 08, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2024
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-11460
|
|
Entity Registrant Name |
Eterna
Therapeutics Inc.
|
|
Entity Central Index Key |
0000748592
|
|
Entity Tax Identification Number |
31-1103425
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
1035
Cambridge Street, Suite 18A
|
|
Entity Address, City or Town |
Cambridge
|
|
Entity Address, State or Province |
MA
|
|
Entity Address, Postal Zip Code |
02141
|
|
City Area Code |
(212)
|
|
Local Phone Number |
582-1199
|
|
Title of 12(b) Security |
Common
stock, $0.005 par value per share
|
|
Trading Symbol |
ERNA
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
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|
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v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 4,264
|
$ 7,575
|
Other receivables |
187
|
425
|
Prepaid expenses and other current assets |
279
|
1,599
|
Total current assets |
4,730
|
9,599
|
Restricted cash |
|
4,095
|
Property and equipment, net |
105
|
493
|
Right-of-use assets - operating leases |
719
|
32,781
|
Goodwill |
2,044
|
2,044
|
Other assets |
120
|
120
|
Total assets |
7,718
|
49,132
|
Current liabilities: |
|
|
Accounts payable |
2,193
|
1,067
|
Accrued expenses |
1,166
|
1,893
|
Income taxes payable |
18
|
2
|
Bridge notes, net of debt discount |
776
|
|
Bridge notes derivative liability |
4,926
|
|
Operating lease liabilities, current |
201
|
2,216
|
Due to related party, current |
559
|
1,205
|
Deferred revenue, current |
|
190
|
Other current liabilities |
113
|
|
Total current liabilities |
9,952
|
6,573
|
Convertible notes, net |
32,037
|
6,773
|
Warrant liabilities |
10,463
|
116
|
Operating lease liabilities, non-current |
534
|
32,854
|
Deferred revenue, non-current |
|
392
|
Contingent consideration liability |
41
|
107
|
Other liabilities |
84
|
84
|
Total liabilities |
53,111
|
46,899
|
Stockholders’ (deficit) equity: |
|
|
Preferred stock, $0.005 par value, 1,000 shares authorized, 156 designated and outstanding of Series A convertible preferred stock at September 30, 2024 and December 31, 2023, $156 liquidation preference |
1
|
1
|
Common stock, $0.005 par value, 100,000 shares authorized at September 30, 2024 and December 31, 2023; 5,411 and 5,410 issued and outstanding at September 30, 2024 and December 31, 2023, respectively |
27
|
27
|
Additional paid-in capital |
180,348
|
189,186
|
Accumulated deficit |
(225,769)
|
(186,981)
|
Total stockholders’ (deficit) equity |
(45,393)
|
2,233
|
Total liabilities and stockholders’ (deficit) equity |
$ 7,718
|
$ 49,132
|
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v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) shares in Thousands, $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.005
|
$ 0.005
|
Preferred stock, shares authorized |
1,000
|
1,000
|
Preferred stock, shares issued |
156
|
156
|
Preferred stock, shares outstanding |
156
|
156
|
Preferred stock, liquidation preference |
$ 156
|
$ 156
|
Common stock, par value |
$ 0.005
|
$ 0.005
|
Common stock, shares authorized |
100,000
|
100,000
|
Common stock, shares issued |
5,411
|
5,410
|
Common stock, shares outstanding |
5,411
|
5,410
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenue |
$ 487
|
$ 51
|
$ 581
|
$ 51
|
Cost of revenues |
(60)
|
120
|
96
|
170
|
Gross income (loss) |
547
|
(69)
|
485
|
(119)
|
Operating expenses: |
|
|
|
|
Research and development |
1,001
|
1,387
|
3,446
|
4,560
|
General and administrative |
3,381
|
4,049
|
11,592
|
10,231
|
Gain on lease termination |
(1,576)
|
|
(1,576)
|
|
Acquisition of Exacis in-process research and development |
|
|
|
460
|
Total operating expenses |
2,806
|
5,436
|
13,462
|
15,251
|
Loss from operations |
(2,259)
|
(5,505)
|
(12,977)
|
(15,370)
|
Other expense, net: |
|
|
|
|
Loss on extinguishment of debt |
(22,440)
|
|
(22,440)
|
|
Fair value adjustments to bridge notes derivative liability |
(1,038)
|
|
(1,038)
|
|
Change in fair value of warrant liabilities |
831
|
20
|
897
|
166
|
Change in fair value of contingent consideration |
|
|
66
|
118
|
Loss on non-controlling investment |
|
|
|
(59)
|
Interest expense, net |
(1,686)
|
(113)
|
(3,269)
|
(88)
|
Other expense, net |
|
(1)
|
|
(281)
|
Total other expense, net |
(24,333)
|
(94)
|
(25,784)
|
(144)
|
Loss before income taxes |
(26,592)
|
(5,599)
|
(38,761)
|
(15,514)
|
(Provision) benefit for income taxes |
(12)
|
8
|
(19)
|
(1)
|
Net loss |
(26,604)
|
(5,591)
|
(38,780)
|
(15,515)
|
Series A preferred stock dividend |
|
|
(8)
|
(8)
|
Net loss attributable to common stockholders |
$ (26,604)
|
$ (5,591)
|
$ (38,788)
|
$ (15,523)
|
Net loss per common share - basic |
$ (4.92)
|
$ (1.03)
|
$ (7.17)
|
$ (2.94)
|
Net loss per common share - diluted |
$ (4.92)
|
$ (1.03)
|
$ (7.17)
|
$ (2.94)
|
Weighted average shares outstanding - basic |
5,410
|
5,410
|
5,410
|
5,281
|
Weighted average shares outstanding - diluted |
5,410
|
5,410
|
5,410
|
5,281
|
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v3.24.3
Condensed Consolidated Statements of Stockholders' (Deficit) Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
Preferred Stock [Member]
Series A Preferred Stock [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2022 |
$ 1
|
$ 26
|
$ 177,377
|
$ (165,297)
|
$ 12,107
|
Beginning balance, shares at Dec. 31, 2022 |
156
|
5,127
|
|
|
|
Stock-based compensation |
|
|
1,077
|
|
1,077
|
Net loss |
|
|
|
(15,515)
|
(15,515)
|
Cash dividends to Series A preferred stockholders |
|
|
|
(8)
|
(8)
|
Issuance of warrants in connection with convertible notes financing |
|
|
5,113
|
|
5,113
|
Issuance of common stock in connection with Exacis asset acquisition |
|
|
208
|
|
208
|
Issuance of common stock in connection with Exacis asset acquisition, shares |
|
69
|
|
|
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net |
|
$ 1
|
579
|
|
580
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net, shares |
|
214
|
|
|
|
Ending balance, value at Sep. 30, 2023 |
$ 1
|
$ 27
|
184,354
|
(180,820)
|
3,562
|
Ending balance, shares at Sep. 30, 2023 |
156
|
5,410
|
|
|
|
Beginning balance, value at Jun. 30, 2023 |
$ 1
|
$ 27
|
179,067
|
(175,229)
|
3,866
|
Beginning balance, shares at Jun. 30, 2023 |
156
|
5,410
|
|
|
|
Stock-based compensation |
|
|
174
|
|
174
|
Net loss |
|
|
|
(5,591)
|
(5,591)
|
Issuance of warrants in connection with convertible notes financing |
|
|
5,113
|
|
5,113
|
Ending balance, value at Sep. 30, 2023 |
$ 1
|
$ 27
|
184,354
|
(180,820)
|
3,562
|
Ending balance, shares at Sep. 30, 2023 |
156
|
5,410
|
|
|
|
Beginning balance, value at Dec. 31, 2023 |
$ 1
|
$ 27
|
189,186
|
(186,981)
|
2,233
|
Beginning balance, shares at Dec. 31, 2023 |
156
|
5,410
|
|
|
|
Fair value of forward sale contract pursuant to common stock offering |
|
|
576
|
|
576
|
Reclassification of warrants to liability |
|
|
(11,244)
|
|
(11,244)
|
Stock-based compensation |
|
|
1,110
|
|
1,110
|
Net loss |
|
|
|
(38,780)
|
(38,780)
|
Issuance of note warrants |
|
|
720
|
|
720
|
Issuance of common stock from vested restricted units |
|
|
|
|
|
Issuance of common stock from vested restricted stock units, shares |
|
1
|
|
|
|
Cash dividends to Series A preferred stockholders |
|
|
|
(8)
|
(8)
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net |
|
8,000
|
|
|
|
Ending balance, value at Sep. 30, 2024 |
$ 1
|
$ 27
|
180,348
|
(225,769)
|
(45,393)
|
Ending balance, shares at Sep. 30, 2024 |
156
|
5,411
|
|
|
|
Beginning balance, value at Jun. 30, 2024 |
$ 1
|
$ 27
|
190,611
|
(199,165)
|
(8,526)
|
Beginning balance, shares at Jun. 30, 2024 |
156
|
5,411
|
|
|
|
Fair value of forward sale contract pursuant to common stock offering |
|
|
576
|
|
576
|
Reclassification of warrants to liability |
|
|
(11,244)
|
|
(11,244)
|
Stock-based compensation |
|
|
405
|
|
405
|
Net loss |
|
|
|
(26,604)
|
(26,604)
|
Ending balance, value at Sep. 30, 2024 |
$ 1
|
$ 27
|
$ 180,348
|
$ (225,769)
|
$ (45,393)
|
Ending balance, shares at Sep. 30, 2024 |
156
|
5,411
|
|
|
|
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v3.24.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (38,780)
|
$ (15,515)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
120
|
62
|
Stock-based compensation |
1,110
|
1,077
|
Amortization of right-of-use asset |
1,450
|
580
|
Gain on lease termination |
(1,576)
|
|
Accrued interest expense |
441
|
113
|
Paid-in-kind interest expense |
829
|
|
Amortization of debt discount and debt issuance costs |
2,148
|
52
|
Loss on extinguishment of debt |
22,440
|
|
Fair value adjustments to bridge notes derivative liability |
1,038
|
|
Change in fair value of warrant liabilities |
(897)
|
(166)
|
Change in fair value of contingent consideration liability |
(66)
|
(118)
|
Commitment shares issued to Lincoln Park Capital, LLC |
|
249
|
Loss on shares sold to Lincoln Park Capital, LLC |
|
11
|
Non-cash component of acquisition of Exacis in-process research and development |
|
433
|
Gain on disposal of fixed assets |
|
1
|
Loss on non-controlling investment |
|
59
|
Changes in operating assets and liabilities: |
|
|
Other receivables |
238
|
(825)
|
Prepaid expenses and other current assets |
1,225
|
340
|
Other non-current assets |
1
|
(2,911)
|
Accounts payable and accrued expenses |
758
|
1,099
|
Operating lease liability |
(1,656)
|
795
|
Due to related party |
(646)
|
(1,313)
|
Deferred revenue |
(582)
|
599
|
Other liabilities |
113
|
(369)
|
Net cash used in operating activities |
(12,291)
|
(15,747)
|
Cash flows from investing activities: |
|
|
Purchase of property and equipment |
(369)
|
|
Proceeds received from the sale of fixed assets |
4
|
|
Net cash used in investing activities |
(365)
|
|
Cash flows from financing activities: |
|
|
Proceeds received from convertible note financings |
1,405
|
8,715
|
Fees paid related to convertible note financings |
(34)
|
(175)
|
Proceeds received from bridge notes financings |
3,887
|
|
Proceeds from sale of common stock pursuant to stock purchase agreement with Lincoln Park Capital Fund, LLC |
|
320
|
Dividends paid to Series A preferred stockholders |
(8)
|
(8)
|
Net cash provided by financing activities |
5,250
|
8,852
|
Net decrease in cash and cash equivalents |
(7,406)
|
(6,895)
|
Cash, cash equivalents and restricted cash at beginning of period |
11,670
|
15,541
|
Total cash, cash equivalents and restricted cash at end of period |
4,264
|
8,646
|
Cash paid during the period for: |
|
|
Interest |
46
|
13
|
Income taxes |
2
|
4
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
Note warrants issued |
755
|
|
Unpaid fees incurred in connection with the December 2023 financing |
32
|
|
Paid in-kind interest added to convertible notes principal |
1,006
|
|
Adjustment to lease liability and ROU asset due to remeasurement |
4,245
|
|
Reclassification of warrants to liability |
11,244
|
|
Warrants issued in connection with July 2023 Financing |
|
5,234
|
Unpaid fees incurred in connection with the July 2023 Financing |
|
27
|
Initial measurement of ROU assets |
|
34,410
|
Initial measurement of lease liability |
|
34,170
|
Contingent consideration for Exacis asset acquisition |
|
225
|
Issuance of common stock for Exacis asset acquisition |
|
208
|
Reconciliation of cash, cash equivalents and restricted cash at end of period: |
|
|
Cash and cash equivalents |
4,264
|
4,551
|
Restricted cash |
|
$ 4,095
|
X |
- DefinitionAdjustment to lease liability and ROU asset due to remeasurement.
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v3.24.3
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
|
9 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION |
1) | DESCRIPTION
OF BUSINESS AND BASIS OF PRESENTATION |
Description
of Business
Eterna
Therapeutics Inc. (the “Company”) is a preclinical-stage cell therapy company. Its vision is to improve the lives
of patients with difficult-to-treat diseases through innovative, effective, and safe, but accessible cellular therapies, and its mission
is to develop allogenic off-the-shelf cellular therapies, leveraging induced pluripotent stem cell (“iPSC”)-derived mesenchymal
stem cells (“iMSCs”) to target solid tumors. As used herein, the “Company” or “Eterna” refers collectively
to Eterna and its consolidated subsidiaries (Eterna Therapeutics LLC, Novellus, Inc. and Novellus Therapeutics Limited) unless otherwise
stated or the context otherwise requires .
Basis
of Presentation
The
accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial statements and with the instructions to Form 10-Q
and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete
financial statements. In the opinion of management, the unaudited financial statements include all the normal recurring adjustments that
are necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented.
These
condensed consolidated financial statements should be read together with the audited consolidated financial statements and notes thereto
contained in Eterna’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission
(the “SEC”) on March 14, 2024, as amended by the Form 10-K/A filed with the SEC on March 18, 2024 (as amended, the “2023
10-K”). The accompanying condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited financial
statements contained in the 2023 10-K but does not include all of the information and footnotes required by GAAP for complete financial
statements. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results
to be anticipated for the entire year ending December 31, 2024, or any other period.
Reclassifications
Certain
reclassifications have been made to the Company’s prior year amounts to conform to the current year presentation.
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v3.24.3
LIQUIDITY AND CAPITAL RESOURCES
|
9 Months Ended |
Sep. 30, 2024 |
Liquidity And Capital Resources |
|
LIQUIDITY AND CAPITAL RESOURCES |
2) | LIQUIDITY
AND CAPITAL RESOURCES |
The Company
has incurred significant operating losses and has an accumulated deficit as a result of its efforts to develop product candidates
and providing general and administrative support for operations. As of September 30, 2024, the Company had an unrestricted cash
balance of approximately $4.3 million and an
accumulated deficit of approximately $225.8
million. For the three and nine months ended September 30, 2024, the Company incurred a net loss of $26.6
million and $38.8
million, respectively, and for the nine months ended September 30, 2024, the Company used cash of $12.3
million in operating activities.
In
October 2022, the Company entered into a sublease for approximately 45,500 square feet of office and laboratory space in Somerville,
Massachusetts. Pursuant to the sublease, the Company delivered to the sublessor a security deposit in the form of a letter of credit
in the amount of $4.1 million. The letter of credit was issued by the Company’s commercial bank, which required that the Company
cash collateralize the letter of credit by depositing $4.1 million in a restricted cash account with such bank.
On
August 5, 2024, the sublessor drew down on the letter of credit for the full $4.1 million to cover past due rent, plus penalties and
interest. On August 9, 2024, the Company and the sublessor entered into a sublease termination agreement, effective August 31, 2024.
See Note 8 for additional information regarding the sublease and sublease termination agreement..
In
April 2023, the Company entered into a standby equity purchase agreement (the “ELOC”) and a registration rights agreement
with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $10.0 million
of the Company’s common stock in an “equity line” financing arrangement. During the year ended December 31, 2023, the
Company issued and sold approximately 214,000 shares of common stock under the ELOC for gross proceeds of $0.3 million. No shares were sold under the ELOC during the three or nine months ended September 30, 2024.
In
July and December 2023, the Company received $16.5 million in aggregate gross proceeds from the issuance of convertible notes, and on
January 11, 2024 it received an additional $1.4 million in gross proceeds from the issuance of additional convertible notes. On September
24, 2024, the Company received $3.9 million in aggregate gross proceeds from the issuance of convertible notes, and on October 29, 2024,
the Company received $1.1 million in gross proceeds from the sale of shares of the Company’s common stock. See Note 5 and Note
17 for additional information regarding these financings.
In
connection with preparing the accompanying condensed consolidated financial statements as of and for the three and nine months ended
September 30, 2024, the Company’s management concluded that there is substantial doubt regarding the Company’s ability to
continue as a going concern because it does not expect to have sufficient cash or working capital resources to fund operations for the
twelve-month period subsequent to the issuance date of these condensed consolidated financial statements. The Company will need to raise
additional capital, which could be through the sales of shares of its common stock under the ELOC, public or private equity offerings,
debt financings, out-licensing the Company’s intellectual property, strategic partnerships or other means. Other than the ELOC,
the Company currently has no arrangements for capital, and no assurances can be given that it will be able to raise capital when needed,
on acceptable terms, or at all.
The
accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. The accompanying condensed consolidated financial statements
do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts
and classifications of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
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v3.24.3
ASSET ACQUISITION
|
9 Months Ended |
Sep. 30, 2024 |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] |
|
ASSET ACQUISITION |
On
April 26, 2023, the Company entered into an asset purchase agreement (the “Exacis Purchase Agreement”), with Dilos Bio (formerly
known as Exacis Biotherapeutics Inc. (“Exacis”)), the stockholders party thereto and, with respect to specified provisions
therein, Factor Limited. Pursuant to the Exacis Purchase Agreement, the Company acquired from Exacis substantially all of Exacis’
intellectual property assets (the “Exacis Assets”), including all of Exacis’ right, title and interest in and to an
exclusive license agreement between Exacis and Factor Limited (the “Purchased License”). The Company assumed none
of Exacis’ liabilities, other than liabilities under the Purchased License that accrue subsequent to the closing date. The transactions
contemplated by the Exacis Purchase Agreement (the “Exacis Acquisition”) closed on April 26, 2023.
In
consideration for the Exacis Assets, on the closing date of the transaction, the Company issued to Exacis approximately 69,000
shares of common stock, which shares were subject
to a 12-month
lockup that expired in April 2024. The shares were issued to Exacis at a price based on the Company having an assumed equity valuation
of $75.0
million, divided by the number of issued and
outstanding shares of common stock as of the close of business two trading days prior to the closing date. For accounting purposes, the
shares issued were valued at $3.00
per share, which was the closing price of the
Company’s common stock on the date of issuance. The Company additionally agreed to make certain contingent payments through April
23, 2026 related to achieving a market capitalization of $100 million and $200 million for a consecutive period of time (the “Market
Cap Contingent Consideration”), as well as contingent payments related to the Company receiving proceeds related to the Purchased
License through April 23, 2028.
The
Company accounted for the Exacis Acquisition as an asset acquisition because it determined that substantially all of the fair value of
the assets acquired was concentrated in the Purchased License. Assets acquired in an asset acquisition are recognized based on their
cost to the acquirer and generally allocated to the assets on a relative fair value basis. The Company’s cost for acquiring the
Exacis Assets includes the issuance of the Company’s common stock, direct acquisition-related costs and contingent consideration.
The table below shows the total fair value of the consideration paid for the Exacis Assets (in thousands). See Note 4 for more information
on the fair value measurement of the assets acquired.
SCHEDULE OF FAIR VALUE MEASUREMENT OF ASSETS ACQUIRED
| |
Fair Value of Consideration | |
Shares issued | |
$ | 208 | |
Contingent consideration | |
| 225 | |
Direct costs | |
| 27 | |
Total fair value | |
$ | 460 | |
The
Company allocated 100% of the fair value of the consideration to the Purchased License, which the Company determined is an in-process
research and development (“IPR&D”) asset. IPR&D assets acquired through an asset purchase that have no alternative
future uses and no separate economic values from their original intended purpose are expensed in the period the cost is incurred. As
a result, the Company expensed the fair value of the Purchased License during the three and nine months ended September 30, 2023.
On
September 24, 2024, in connection with entering into the Exclusive License and Collaboration Agreement (“the Factor L&C Agreement”)
with Factor Bioscience Limited (“Factor Limited”), the Purchase License was terminated. See Note 10 for more information
on the Factor L&C Agreement.
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v3.24.3
CONTRACT WITH CUSTOMER
|
9 Months Ended |
Sep. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
CONTRACT WITH CUSTOMER |
On
February 21, 2023, the Company and Lineage Cell Therapeutics, Inc. (“Lineage”) entered into an exclusive option and
license agreement (the “Lineage Agreement”), which provided Lineage with the option (the “Option Right”) to
obtain an exclusive sublicense of intellectual property from the Company and to request the Company to develop a customized cell
line (the intellectual property that would be sublicensed by Lineage is currently licensed by the Company from Factor Limited). The
Lineage Agreement was amended in August 2023 to provide for changes specifically related to the cell line customization activities
such as (i) payment terms, (ii) certain definitions, (iii) certain courses of action if the customized cell line selected by Lineage
is not successful and (iv) documentation requirements. Lineage paid the Company a $0.3
million non-refundable up-front payment (the “Option Fee”) for the Option Right and paid an initial payment of $0.4
million to commence the cell line customization activities, per the amended payment terms. If Lineage obtained the sublicense, the
Company would be entitled to receive additional license fees, including milestone payments and royalties.
On
September 24, 2024, the Company and Factor Bioscience (as defined in Note 10) entered into an agreement (the “Lineage Assignment
Agreement”) under which the Company assigned the Lineage Agreement to Factor Bioscience. The Company’s rights and obligations
under the agreement are now the responsibility of Factor Bioscience.
Payments
to the Company related to the Lineage Agreement will be subject to the Lineage Assignment Agreement, which provides for Factor Bioscience
paying the Company thirty percent (30%) of all amounts it actually receives from Lineage in the event that Lineage exercises its Option
Right. Upon receipt of payment for the customization activities set forth in the Lineage Agreement, Factor Bioscience will pay the Company
twenty percent (20%) of all amounts Factor Bioscience receives from Lineage.
The
Company recognizes revenue under ASC 606, Revenue from Contracts with Customers (“ASC 606”) when a customer obtains
control of promised services or goods in an amount that reflects the consideration to which the Company expects to receive in exchange
for those goods or services.
Pursuant
to ASC 606, the Company determined that the Option Right was an unexercised right held by Lineage under the Lineage Agreement at contract
inception, as the cell line customization activities and the sublicense were optional purchases at contract inception. These optional
purchases of goods and services would be treated as separate contracts if and when Lineage determines that it would make such purchases.
Therefore, 100% of the Option Fee was allocated to the Option Right. The Option Fee would remain in deferred revenue until such time
that Lineage entered into the sublicense or when the Option Right expired. However, as a result of the Lineage Assignment Agreement,
and there being no further obligations regarding the nonrefundable payment related to the Option Right, the Company recognized the $0.3
million Option Right payment in full as revenue during the three and nine months ended September 30, 2024.
The
Option Right and the cell line customization activities were accounted for as separate contracts, and the Company determined that the
amended terms discussed above represented a modification to the cell line customization contract. Because there were no goods or services
transferred to Lineage before entering into the amendment, and therefore, no previously recognized revenue, there was no catch-up adjustment
to revenue required at the time of the amendment.
Lineage
was to make payments to the Company for the cell line customization activities over the development period. The Company would only earn
the remaining full amount of the cell line customization fee if it made certain progress towards delivery of the customized cell line.
The Company determined that $0.4 million of consideration received could be recognized without the probability of being reversed, and
it placed a constraint on the remaining contractual customization fee. The $0.4 million was being recognized equally over the development
period. However, as a result of the Lineage Assignment Agreement, and there being no further obligations the Company must fulfill for
the customization activities, the Company accelerated the recognition of the remaining deferred revenue and recognized approximately
$0.2 million during the three and nine months ended September 30, 2024. The Company recognized approximately $0.1 million in revenue during
the three and nine months ended September 30, 2023 related to the customization activities.
The
Company recognized direct labor and supplies used in the customization activities as incurred, which are recorded as a cost of revenue.
As provided for in the A&R Factor License Agreement discussed in Note 10, the Company was obligated to pay Factor Limited 20% of
any amounts the Company received from a customer that was related to the licensed technology under the A&R Factor License Agreement,
which is also recorded as a cost of revenue. For the three and nine months ended September 30, 2023, the Company recognized $0.1 million
in license fees, which is recorded in cost of revenues, due to Factor Limited. There was no such license fee incurred during the three
or nine months ended September 30, 2024.
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v3.24.3
CONVERTIBLE NOTES FINANCINGS, BRIDGE FINANCING, EXCHANGE TRANSACTION AND EQUITY FINANCING
|
9 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
CONVERTIBLE NOTES FINANCINGS, BRIDGE FINANCING, EXCHANGE TRANSACTION AND EQUITY FINANCING |
5) | CONVERTIBLE
NOTES FINANCINGS, BRIDGE FINANCING, EXCHANGE TRANSACTION AND EQUITY FINANCING |
On
July 14, 2023, the Company received $8.7 million from a private placement in which the Company issued $8.7 million in aggregate principal
amount of convertible notes (the “July 2023 Convertible Notes”) and warrants to purchase an aggregate of approximately 6.1
million shares of its common stock (the “July 2023 Warrants”). The Company recognized approximately $0.2 million in fees associated
with the transaction.
On
December 14, 2023, the Company entered into a purchase agreement with certain purchasers for the private placement of $9.2 million of
convertible notes (the “December 2023 Convertible Notes” and together with the July 2023 Convertible Notes, the “Convertible
Notes”) and warrants to purchase an aggregate of approximately 9.6 million shares of the Company’s common stock (the “December
2023 Warrants” and together with the July 2023 Warrants, the “Note Warrants”).
There
were two closings under the December 14, 2023 purchase agreement – one on December 15, 2023 and the second on January 11, 2024.
At the first closing, the Company received $7.8 million and issued $7.8 million of December 2023 Convertible Notes and December 2023
Warrants to purchase approximately 8.1 million shares of its common stock. At the second closing, the Company received $1.4 million and
issued $1.4 million of December 2023 Convertible Notes and December 2023 Warrants to purchase approximately 1.5 million shares its common
stock.
See
Note 13 for more information on the Note Warrants.
The
July 2023 Convertible Notes bear interest at 6% per year, and the December 2023 Convertible Notes bear interest at 12% per year, both
of which are payable quarterly in arrears. At the Company’s election, it may pay interest either in cash or in-kind by increasing
the outstanding principal amount of the Convertible Notes. The Convertible Notes mature on the five-year anniversary of the date of their
issuance, unless earlier converted or repurchased. The Company does not have the option to redeem any of the Convertible Notes prior
to maturity.
At
the option of the holders, the Convertible Notes may be converted from into shares of the Company’s
common stock at an initial conversion price of, with respect to the July 2023 Convertible Notes, $2.86 per share and, with respect to
the December 2023 Convertible Notes, $1.9194 per share, subject to customary adjustments for stock splits, stock dividends, recapitalization
and the like.
As
of September 30, 2024, none of the Convertible Notes were converted into shares of common stock.
The
Convertible Notes provide for customary events of default which include (subject in certain cases to customary grace and cure periods),
among others: nonpayment of principal or interest, breach of covenants or other agreements in the Convertible Notes; the occurrence of
a material adverse effect event (as defined in the related securities purchase agreement) and certain events of bankruptcy. Generally,
if an undisputed event of default occurs and is continuing under the Convertible Notes, the holder may require the Company to
redeem some or all of their Convertible Notes at a redemption price equal to 100% of the principal amount of the Convertible Notes being
redeemed, plus accrued and unpaid interest thereon. As of September 30, 2024, there were no events of default that occurred under any
of the Convertible Notes.
Bridge
Notes Financing
On
September 24, 2024, the Company entered into a purchase agreement with certain purchasers for the private placement of $3.9 million of
convertible notes (the “Bridge Notes”). The Bridge Notes bear interest at 12% per year, payable quarterly in arrears. At
the Company’s election, it may pay interest either in cash or in-kind by increasing the outstanding principal amount of the Bridge
Notes. The Bridge Notes mature on the one-year anniversary of the date of their issuance, unless earlier converted or repurchased. The
Company does not have the option to redeem any of the Bridge Notes prior to maturity. The Bridge Notes financing closed on September
24, 2024.
The
only conversion event for the Bridge Notes is upon stockholder approval at the Company’s annual meeting of stockholders on October
29, 2024 (the “Annual Meeting), in which case, 100% of the principal amount of the Bridge Notes plus all accrued and unpaid interest
thereon and, interest that would have accrued on the principal amount through December 24, 2024, will automatically convert into shares
of the Company’s common stock at a conversion price of $0.50. Otherwise, the Bridge Notes may be paid in cash upon maturity.
The Bridge Notes
have the same customary events of default provision as the Convertible Notes. As of September 30, 2024, there were no events of default
that occurred under any of the Bridge Notes.
The
Company was required to bifurcate the conversion feature from the Bridge Notes and record it as a derivative liability at its fair
value. The Company determined the fair value of the derivative liability by taking the difference between the fair value of the
Bridge Notes with the conversion feature and without the conversion feature, which resulting in the Company recording a $5.5
million derivative liability, with a corresponding $3.9
million reduction in the carrying value of the Bridge Notes recorded as a debt discount
and a $1.6
million charge to expense for the incremental fair value of the derivative liability as of September 24, 2024. The debt discount is are amortized over the
contractual terms of the Bridge Note as a component of interest expense.
At September 30, 2024, the Company
remeasured the fair value of the Bridge Notes derivative liability and recorded a reduction in the liability of $0.6 million. The corresponding credit of $0.6 million is recorded as a component of the fair value adjustments to Bridge
Notes derivative liability on the accompanying condensed consolidated statement of operations for the three and nine months ended September
30, 2024, which also includes the $1.6 million incremental expense noted above.
Exchange
Transaction
On
September 24, 2024, the Company entered into exchange agreements (the “Exchange Agreements”) with the holders of (i) warrants
to purchase an aggregate of approximately 4.4 million shares of our common stock the Company issued in December 2022 with an exercise
price of $1.43 per share (the “December 2022 warrants”); (ii) the July 2023 convertible notes and July 2023 warrants; and
(iii) the December 2023 convertible notes and the December 2023 warrants (the “Exchange Transactions”). The parties to the
Exchange Agreements represent the holders of all the outstanding convertible notes and all the outstanding warrants described above except
for a December 2022 warrant to purchase approximately 0.1 million shares of our common stock.
Subject
to approval by the Company’s stockholders at the Annual Meeting, under the Exchange Agreements (i) the holders of the warrants
agreed to exchange all their warrants for shares of the Company’s common stock at an exchange ratio of 0.5 of a share of common
stock for every one share of common stock issuable upon exercise of the applicable warrant (rounded up to the nearest whole number),
and (ii) the holders of the convertible notes agreed to exchange all their convertible notes for shares of the Company’s common
stock at an exchange ratio equal to (A) the sum expressed in U.S. dollars of (1) the principal amount of the applicable convertible note,
plus (2) all accrued and unpaid interest thereon through the date the applicable convertible note is exchanged plus (3) all interest
that would have accrued through, but not including, the maturity date of applicable convertible note if it was outstanding from the date
such convertible note is exchanged through its maturity date (the sum of (A) totaling approximately $28.4 million), divided by (B) $1.00
(rounded up to the nearest whole number) (the “Exchange Transactions”).
The
Company determined that the modifications to the convertible notes should be accounted for as an extinguishment of debt because there
was at least a 10% change in the cash flows of the modified debt instrument compared to the carrying amount of the original debt instrument,
and as such, the difference between the reacquisition price (which includes any premium) and the net carrying amount of the debt being
extinguished (which includes any deferred debt issuance costs) should be recognized as a gain or loss when the debt is extinguished.
As
of September 24, 2024, prior to entering into the Exchange Agreements, there was approximately $10.1 million of net carrying amount of
the convertible notes, which was comprised of $19.4 million of principal and accrued interest through such date, offset by approximately
$9.3 million of unamortized debt issuance costs. The fair value of the reacquired convertible notes was $32.0 million and was determined
by multiplying approximately 28,351,000 shares the Company would be issuing on October 29, 2024 by the closing stock price of $1.13 per
share on September 24, 2024. The difference between the reacquisition price and the net carrying amount of the convertible notes being
extinguished was approximately $21.9 million. Accordingly, the Company increased the carrying value of the reacquired convertible notes
to $32.0 million and recognized a loss on extinguishment of debt of approximately $21.9 million during the three and nine months ended
September 30, 2024.
Because shareholder approval was required for the Exchange Transactions
to occur, the Company determined that the modifications to the warrants resulted in a change in classification of such warrants from equity
to liability. A provision that requires shareholder approval precludes equity classification because such approval is not an input into
a fixed-for-fixed valuation model. As a result, the Company recorded the warrants at fair value as of September 24, 2024 by taking the
number of shares of common stock issuable from the exchanged warrants multiplied by the closing stock price of $1.13 and reclassified
approximately $11.2 million from equity to warrant liabilities. The Company then marked-to-market the warrants as of September 30, 2024
by taking the same quantity of shares multiplied by the closing stock price on such date and recognized a reduction to the warrant liabilities
of $0.8 million. A corresponding credit of $0.8 million was recognized as a change in fair value of warrant liabilities for the three
and nine months ended September 30, 2024 on the accompanying condensed consolidated statement of operations.
Equity
Financing
On
September 24, 2024, the Company entered into a securities purchase agreement (the “SPA”) with certain accredited investors
to sell in a private placement an aggregate of approximately 1,517,000 shares of the Company’s common stock (or, in lieu thereof,
pre-funded warrants to purchase one share of our common stock) for a purchase price of $0.75 per share of common stock and $0.745 per pre-funded warrant (the “Common Stock Private Placement” and together with the Bridge Notes
and the Exchange Transactions, the “September 2024 Transactions”). The closing of the Common Stock Private Placement was
conditioned upon receiving stockholder approval at the Annual Meeting.
The
SPA represents a forward sale contract obligating the Company to sell a fixed number of shares of its common stock at a fixed price per
share upon obtaining shareholder approval at the Annual Meeting. The Company measured the fair value of the forward sale contract as
the difference between (A) the fair value of the expected shares to be purchased by the investors as of the date the Company entered
into the SPA and (B) the purchase price of the shares, and recorded approximately $0.6 million to additional paid-in capital as of September
24, 2024. Because of the concurrent execution of the SPA and the Exchange Agreements, and because the investors in the SPA are also parties
to the Exchange Transactions, the $0.6 million was added to the $21.9 million loss on extinguishment of debt discussed above for a total
loss of $22.4 million during the three and nine months ended September 30, 2024.
On
October 29, 2024, the Company held its Annual Meeting, the Company’s stockholders approved the September 2024 Transactions, and
as a result, the following occurred on October 29, 2024:
| ● | Under
the Common Stock Private Placement, the Company issued approximately 1,402,000 shares of
common stock and pre-funded warrants to purchase 115,000 shares of common stock and received
approximately $1.1 million in gross proceeds from the issuance of such securities. The pre-funded
warrants have an exercise price of $0.005 per share, are exercisable at any
time and will not expire until exercised in full. |
| | |
| ● | Under
the Bridge Notes, approximately $3.0 million of the principal amount of the bridge notes
plus all accrued and unpaid interest thereon, plus such amount of interest that would have
accrued on the principal amount through December 24, 2024, was automatically converted at
a conversion price of $0.50 into approximately 6,244,000 shares of the Company’s common
stock and approximately $0.9 million of the principal amount of the bridge notes plus all
accrued and unpaid interest thereon, plus such amount of interest that would have accrued
on the principal amount through December 24, 2024, was automatically converted at a conversion
price of $0.50 into pre-funded warrants to purchase 1,764,000 shares of common stock. The
pre-funded warrants have an exercise price of $0.005 per share, are exercisable
at any time and will not expire until exercised in full. As of October 29, 2024, there were
no Bridge Notes outstanding. |
| | |
| ● | Under
the Exchange Transactions, (i) the holders of the warrants exchanged approximately 19,902,000
warrants for approximately 9,951,000 shares of the Company’s common stock, and (ii)
the holders of the convertible notes exchanged all their convertible notes for approximately
28,351,000 shares of our common stock for a total of 38,302,000 shares of our common stock
under the Exchange Transactions. As of October 29, 2024, there were no Convertible Notes
outstanding. |
|
X |
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.3
FAIR VALUE OF FINANCIAL INSTRUMENTS
|
9 Months Ended |
Sep. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE OF FINANCIAL INSTRUMENTS |
6) | FAIR
VALUE OF FINANCIAL INSTRUMENTS |
Fair
value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between
willing market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted
prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy
is as follows:
●
Level 1 Inputs – Valued based on quoted prices in active markets for identical assets or liabilities that the reporting entity
has the ability to access at the measurement date.
●
Level 2 Inputs – Valued based on inputs other than quoted prices included in Level 1 that are observable for the asset or
liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets,
quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that
are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs
that are derived principally from or corroborated by market data by correlation or other means.
●
Level 3 Inputs – Valued based on inputs for which there is little or no market value, which require the reporting entity to
develop its own assumptions.
The
carrying amounts reported on the balance sheet for cash, other receivable, prepaid assets and other current assets, accounts payable
and accrued expenses, other current liabilities and other liabilities approximate fair value based due to their short maturities.
The
Company issued approximately 343,000 warrants in connection with a private placement during the first quarter of 2022 (the “Q1-22
warrants”), which were determined to be classified as a liability. The Company also recorded the Market Cap Contingent Consideration
liability related to the Exacis Acquisition. See Note 3 for more information related to the Exacis Acquisition.
In
connection with the Bridge Notes, the Company recorded a derivative liability as of September 24, 2024. In connection with the Exchange
Transactions, on September 24, 2024, the Company reclassified the warrants included in the Exchange Transactions from equity to a liability.
See Note 5 for more information related to the Bridge Notes and Exchange Transactions.
The
Company uses a Black-Scholes option pricing model to estimate the fair value of the Q1-22 warrant liabilities and a Monte Carlo simulation
model to estimate the fair value of the contingent consideration related to the Market Cap Contingent Consideration, both of which are
considered a Level 3 fair value measurement.
The
Company determined the fair value of the derivative liability by taking the difference between the fair value of the Bridge Notes with
the conversion feature and without the conversion feature.
With
respect to the warrants in the Exchange Transactions, the Company determined the fair value of the warrants as of September 24, 2024
by taking the number of shares of common stock issuable from the exchanged warrants multiplied by the closing stock price of $1.13 and
reclassified approximately $11.2 million from equity to warrant liabilities.
The Company remeasures the fair value of the warrant liabilities, the Bridge Notes derivative liability and the Market Cap Contingent
Consideration at each reporting period and changes in the fair values are recognized in the statement of operations.
The
following tables summarize the liabilities that are measured at fair value as of September 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE
Description | |
Level | | |
September 30, 2024 | | |
December 31, 2023 | |
Liabilities: | |
| | | |
| | | |
| | |
Warrant liabilities - Q1-22 warrants | |
| 3 | | |
$ | 15 | | |
$ | 116 | |
Warrant liabilities – Exchange Transactions | |
| 3 | | |
$ | 10,448 | | |
$ | - | |
Bridge Notes derivative liability | |
| 3 | | |
$ | 4,926 | | |
$ | - | |
Market Cap Contingent Consideration | |
| | | |
| - | | |
| - | |
Liability fair value disclosure | |
| | | |
| - | | |
| - | |
Certain
inputs used in Black-Scholes and Monte Carlo models may fluctuate in future periods based upon factors that are outside of the Company’s
control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change
to the fair value of the Company’s warrant liabilities or contingent consideration liabilities, which could also result in material
non-cash gains or losses being reported in the Company’s condensed consolidated statement of operations.
The
following table presents the changes in the liabilities measured at fair value from January 1, 2024 through September 30, 2024 (in thousands):
SCHEDULE
OF CHANGES IN WARRANT LIABILITIES
| |
Warrant Liabilities | |
|
Derivative
Liability |
| |
Contingent Consideration | |
| |
| |
|
|
| |
| |
Fair value at January 1, 2024 | |
$ | 116 | |
|
$ |
- |
| |
$ | 107 | |
Reclassification of warrants from equity to liability | |
| 11,244 | |
|
|
- |
| |
| - | |
Initial measurement of Bridge Notes derivative liability | |
| - | |
|
|
5,566 |
| |
| - | |
Change in fair value | |
| (897 | ) |
|
|
(640 |
) | |
| (66 | ) |
Fair value at September 30, 2024 | |
$ | 10,463 | |
|
$ |
4,926 |
| |
$ | 41 | |
The
Company assessed the fair value of the Market Cap Contingent Consideration at September 30, 2024 and determined that there were no material
changes to the inputs used in the June 30, 2024 remeasurement that would have resulted in a material change to the liability at September
30, 2024. Therefore, the Company did not recognize a change in fair value of the Market Cap Contingent Consideration for the three months
ended September 30, 2024.
The
Company remeasured the Bridge Notes derivative
liability by taking the difference between the fair value of the Bridge Notes with the conversion feature and without the conversion feature
as of September 30, 2024 and recorded a $0.6 million credit for the change in fair value during the three months ended September 30, 2024.
The
table below is provided for comparative purposes only and presents information about the fair value of the Company’s convertible
notes relative to the carrying values recognized in the condensed consolidated balance sheet as of September 30, 2024 and December 31,
2023 (in thousands).
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES
| |
| | |
September 30, 2024 | | |
December 31, 2023 | |
| |
Level | | |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
Convertible Notes | |
| 3 | | |
$ | 32,037 | | |
$ | 29,768 | | |
$ | 16,616 | | |
$ | 17,594 | |
Bridge Notes | |
| 3 | | |
$ | 3,887 | | |
$ | 8,409 | | |
$ | - | | |
$ | - | |
The
carrying value of the Convertible Notes in the table above is reflective of the reacquisition price of the Convertible Notes as a
result of the Exchange Agreements entered into on September 24, 2024, which was recorded at its fair value as of September 24, 2024. The Company determined the fair value of the Convertible Notes by multiplying the 28.4 million shares expected to
be issued in common stock on October 29, 2024 by the closing stock price of $1.05 per share on September 30, 2024.
The
carrying value of the Bridge Notes in the table above is shown before the bifurcation of the Bridge Notes derivative liability. The Company
determined the fair value of the Bridge Notes by multiplying the 8.0
million shares expected to be issued in common stock (or in pre-funded warrants)
on October 29, 2024 by the closing stock price of $1.05
per share on September 30, 2024.
See
Note 5 for more information on the Convertible Notes and the Bridge Notes.
The
Company assessed the fair value of the 2023 convertible notes as of December 31, 2023 using a binomial model, which is considered a Level
3 measurement.
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v3.24.3
GOODWILL
|
9 Months Ended |
Sep. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
GOODWILL |
In
2018, the Company acquired IRX Therapeutics (“IRX”), which was accounted for as a business combination. The Company recorded
goodwill in the amount of $2.0 million related to the IRX acquisition. Goodwill is not amortized but is tested for impairment annually,
or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value
of the entity is less than its carrying value. As of September 30, 2024, the Company did not identify potential triggering events that
could indicate that the fair value of the entity is less than its carrying value and determined there were no such events that occurred.
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v3.24.3
LEASES
|
9 Months Ended |
Sep. 30, 2024 |
Leases [Abstract] |
|
LEASES |
The
Company currently has operating leases for office in the borough of Manhattan in New York, New York, and Cambridge,
Massachusetts, which expire in 2026 and 2028, respectively.
In
addition, in October 2022, the Company entered into a sublease with a subsidiary of Bristol-Myers Squibb Company, as sublessor (“Sublessor”),
for office, laboratory and research and development space of approximately 45,500 square feet in Somerville, Massachusetts. The sublease
provided for base rental payments of approximately $0.5 million per month as well as monthly payments for parking and the Company’s
share of traditional lease expenses, including certain taxes, operating expenses and utilities. The Company paid the Sublessor a security
deposit in the form of a letter of credit in the amount of approximately $4.1 million.
On
May 3, 2024, the Company received a notice from the Sublessor regarding past due rent payments of approximately $2.3 million, including
amounts related to property taxes and common area maintenance costs, that the Company did not pay for the months of February, March,
April and May 2024. Failure to pay the past due rent payments in full, plus approximately $70,000 in late fees and interest, within five
business days from the date of the notice constitutes an event of default under the sublease.
The
Company also did not pay the rent for June, July or August 2024 and, as of August 1, 2024, owed approximately $4.0 million in the aggregate
in past due rent. On August 5, 2024, the Sublessor drew down on the letter of credit for the full $4.1 million to cover the approximately
$4.0 million of past due rent payments, plus interest and penalties.
On
August 9, 2024, the Company and Sublessor entered into a sublease termination agreement, effective August 31, 2024. The sublease was
originally scheduled to expire in 2033. Pursuant to the sublease termination agreement, the Company agreed to the following: to surrender
and vacate the premises; that the Company’s right, title and interest in all furniture, fixtures and laboratory equipment at the
premises will become the property of the sublessor; and that both parties will be released of their obligations under the sublease. As
a result of the sublease termination, the Company recognized a gain on lease termination of approximately $1.6 million for the three
and nine months ended September 30, 2024, which includes a loss on disposal of fixed assets of approximately $0.5 million.
For
the three and nine months ended September 30, 2024 and 2023, the net operating lease expenses were as follows (in thousands):
NET
OPERATING LEASE EXPENSE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease expense | |
$ | 1,110 | | |
$ | 1,623 | | |
$ | 4,380 | | |
$ | 1,758 | |
Sublease income | |
| (21 | ) | |
| (21 | ) | |
| (63 | ) | |
| (63 | ) |
Variable lease expense | |
| 225 | | |
| 6 | | |
| 887 | | |
| 18 | |
Total lease expense | |
$ | 1,314 | | |
$ | 1,608 | | |
$ | 5,204 | | |
$ | 1,713 | |
The
tables below show the beginning balances of the operating ROU assets and lease liabilities as of January 1, 2024 and the ending balances
as of September 30, 2024, including the changes during the period (in thousands).
OPERATING
LEASE RIGHT-OF-USE ASSETS AND LIABILITIES
| |
Operating Lease ROU Assets | |
| |
| |
Operating lease ROU assets at January 1, 2024 | |
$ | 32,781 | |
Adjustment to ROU asset for remeasurement of | |
| | |
Somerville Sublease liability | |
| 4,245 | |
Write-off of Somerville Sublease ROU asset | |
| (34,857 | ) |
Amortization of operating lease ROU assets | |
| (1,450 | ) |
Operating lease ROU assets at September 30, 2024 | |
$ | 719 | |
| |
Operating Lease Liabilities | |
Operating lease liabilities at January 1, 2024 | |
$ | 35,070 | |
Adjustment to lease liability due to remeasurement of Somerville Sublease | |
| 4,245 | |
Accretion of interest for Somerville Sublease | |
| 2,465 | |
Write-off of Somerville Sublease liability | |
| (36,924 | ) |
Principal payments on operating lease liabilities | |
| (4,121 | ) |
Operating lease liabilities at September 30, 2024 | |
| 735 | |
Less non-current portion | |
| 534 | |
Current portion at September 30, 2024 | |
$ | 201 | |
As
of September 30, 2024, the Company’s operating leases had a weighted-average remaining life of 3.3 years with a weighted-average
discount rate of 10.23%. The maturities of the operating lease liabilities are as follows (in thousands):
MATURITIES
OF OPERATING LEASE LIABILITIES
| |
As of September 30, 2024 | |
2024 | |
$ | 69 | |
2025 | |
| 274 | |
2026 | |
| 267 | |
2027 | |
| 163 | |
2028 | |
| 82 | |
Total payments | |
| 855 | |
Less imputed interest | |
| (120 | ) |
Total operating lease liabilities | |
$ | 735 | |
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v3.24.3
ACCRUED EXPENSES
|
9 Months Ended |
Sep. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
Accrued
expenses at September 30, 2024 and December 31, 2023 consisted of the following (in thousands):
SCHEDULE
OF ACCRUED EXPENSES
| |
September 30, 2024 | | |
December 31,
2023 | |
Professional fees | |
$ | 290 | | |
$ | 239 | |
Legal fees | |
| 267 | | |
| 643 | |
Accrued compensation | |
| 108 | | |
| 109 | |
Convertible notes interest | |
| 38 | | |
| 176 | |
Somerville facility | |
| - | | |
| 218 | |
Other | |
| 463 | | |
| 508 | |
Total accrued expenses | |
$ | 1,166 | | |
$ | 1,893 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.3
RELATED PARTY TRANSACTIONS
|
9 Months Ended |
Sep. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
10) | RELATED
PARTY TRANSACTIONS |
Agreements
with Factor Bioscience Inc. and Affiliates
As
of September 30, 2024, the Company had entered into the agreements described below with Factor Bioscience Inc. and/or Dr. Matthew
Angel. These agreements have been deemed related party transactions because the Company’s former chief executive officer, Dr.
Angel, is the chairman and chief executive officer of Factor Bioscience Inc. and a director of its subsidiary, Factor Bioscience
Limited (“Factor Limited” and together with Factor Bioscience Inc. and its other affiliates, “Factor
Bioscience”). Dr. Angel resigned as the Company’s chief executive officer effective December 31, 2023.
In
September 2022, the Company entered into a Master Services Agreement (the “MSA”) with Factor Bioscience, pursuant to which
Factor Bioscience agreed to provide services to the Company as agreed between the Company and Factor Bioscience and as set forth in one
or more work orders under the MSA, including the first work order included in the MSA (“WO1”). The MSA contains customary
confidentiality provisions and representations and warranties of the parties, and the MSA may be terminated by either party upon 30 days’
prior notice, subject to any superseding termination provisions contained in a particular work order.
Under
WO1, Factor Bioscience agreed to provide the Company with mRNA cell engineering research support services, including access to certain
facilities, equipment, materials and training, and the Company agreed to pay Factor Bioscience an initial fee of $5.0 million, payable
in 12 equal monthly installments of approximately $0.4 million. Of the $5.0 million, the Company allocated $3.5 million to the License
Fee Obligation (as defined below). Following the initial 12-month period, the Company agreed to continue paying Factor Bioscience the
monthly fee of $0.4 million until such time as WO1 is terminated. Upon entering into the MSA, the Company paid a deposit of $0.4 million,
which will be applied to the last month of WO1.
Under
the terms of an amendment to WO1, the Company may terminate WO1 on or after the second anniversary of the date of the MSA, subject to
providing Factor Bioscience with 75 days’ prior notice if such notice is provided no later than June 30, 2024. On June 26, 2024,
the Company provided Factor Bioscience with its notice to terminate WO1, which became effective on September 9, 2024.
In
connection with entering into the MSA, Factor Limited entered into a waiver agreement with Eterna LLC, pursuant to which Factor Limited
agreed to waive payment of $3.5 million otherwise payable to it (the “License Fee Obligation”) in October 2022 by Eterna
LLC under the exclusive license agreement entered into in April 2021 among Eterna LLC, Novellus Limited and Factor Limited (the
“Original Factor License Agreement”). Under the waiver agreement, the License Fee Obligation is waived conditionally
on the Company paying Factor Bioscience a minimum of $3.5 million due under the MSA.
Because
the License Fee Obligation was conditionally waived until the Company paid Factor Bioscience a minimum of $3.5 million under the MSA,
the Company recorded a liability of $3.5 million. As of September 30, 2024, there was no License Fee Obligation liability remaining.
In
September 2022, Novellus Inc. (“Novellus”) and the Company entered into a Second Amendment to the Limited Waiver and Assignment
Agreement (the “Waiver and Assignment Agreement”) with Drs. Matthew Angel and Christopher Rohde (the “Founders”)
whereby the Company agreed to be responsible for all future, reasonable and substantiated legal fees, costs, settlements and judgments
incurred by the Founders, the Company or Novellus for certain claims and actions and any pending or future litigation brought against
the Founders, Novellus and/or the Company by or on behalf of the Westman and Sowyrda legal matters described in Note 10 (the “Covered
Claims”). The Founders will continue to be solely responsible for any payments made to satisfy a judgement or settlement of any
pending or future wage act claims. Under the Waiver and Assignment Agreement, the Founders agreed that they are not entitled to, and
waived any right to, indemnification or advancement of past, present or future legal fees, costs, judgments, settlement or other liabilities
they may have been entitled to receive from the Company or Novellus in respect of the Covered Claims. The Company and the Founders will
share in any recoveries up to the point at which the parties have been fully compensated for legal fees, costs and expenses incurred,
with the Company retaining any excess recoveries. The Company has the sole authority to direct and control the prosecution, defense and
settlement of the Covered Claims.
In
November 2022, following the expiration of one of the milestone deadlines for certain regulatory filings required under the Third Amended
and Restated Exclusive License Agreement between Novellus Limited and Factor Limited entered into in November 2020 (the “Novellus-Factor
License Agreement”), which permitted Factor Limited to terminate the license granted to Novellus Limited thereunder, the Company
entered into the first amendment to the Original Factor License Agreement (as amended, the “2021 Factor License Agreement”),
pursuant to which, among other things, Factor Limited granted to Eterna LLC an exclusive, sublicensable license under certain patents
owned by Factor Limited (the “Factor Patents”) for the purpose of identifying and pursuing certain opportunities to grant
to third parties sublicenses to the Factor Patents. The Original Factor License Agreement also (i) terminated the Novellus-Factor License
Agreement, (ii) confirmed Factor Limited’s grant to Eterna LLC of the rights and licenses Novellus Limited previously granted to
Eterna LLC under the Novellus-Factor License Agreement on the same terms and conditions as granted by Novellus Limited to Eterna LLC
under such agreement, (iii) confirmed that the sublicense granted by Novellus Limited in accordance with the Novellus-Factor License
Agreement to NoveCite, Inc., a company which the Company has a 25% non-controlling interest (“NoveCite”), survived termination
of the Novellus-Factor License Agreement; and (iv) removed Novellus Limited from the Original Factor License Agreement and the license
agreement entered into on October 6, 2020 between Novellus Limited and NoveCite, Inc, as amended, and replaced Novellus Limited with
Factor Limited as the direct licensor to Eterna LLC and NoveCite under such agreements, respectively.
On
February 20, 2023, the Company, entered into an exclusive license agreement (the “Feb 2023 Factor Exclusive License Agreement”)
with Factor Limited, pursuant to which Factor Limited granted to the Company an exclusive, sublicensable, worldwide license under certain
patents owned by Factor Limited for the purpose of, among other things, identifying and pursuing certain opportunities to develop products
in respect of such patents and to otherwise grant to third parties sublicenses to such patents. The Feb 2023 Factor Exclusive License
Agreement, which terminated and superseded the Amended Factor License Agreement, was subsequently terminated and superseded by the A&R
Factor License Agreement (as defined below).
On
November 14, 2023, the Company entered into an amended and restated exclusive license agreement (the “A&R Factor License Agreement”)
with Factor Limited to replace in its entirety the exclusive license agreement between the parties dated February 20, 2023 and the amendment
thereto. Under the A&R Factor License Agreement, Factor Limited granted to the Company an exclusive, sublicensable license
under certain patents owned by Factor Limited (the “Factor Patents”). The A&R Factor License Agreement also provides
for, among other things, the expansion of the Company’s license rights to include (i) the field of use of the Factor Patents to
include veterinary uses (ii) know-how that is necessary or reasonably useful to practice to the licensed patents, (iii) the ability to
sublicense through multiple tiers (as opposed to only permitting a direct sublicense) and (iv) the transfer of technology to the Company,
subject to the use restrictions in the A&R Factor License Agreement. The A&R Factor License Agreement was subsequently terminated
and superseded by the Factor L&C Agreement discussed below.
On
September 24, 2024, the Company entered into the Factor L&C Agreement, effective as of September 9, 2024, with Factor Limited. The
Factor L&C Agreement terminated the A&R Factor License Agreement as well as the Purchased License that Exacis entered into with
Factor Bioscience on November 4, 2020, which the Company acquired pursuant to the Exacis Purchase Agreement with Exacis and certain stockholders
of Exacis on April 26, 2023.
Under
the Factor L&C Agreement, the Company has obtained exclusive licenses in the fields of cancer, autoimmune disorders, and rare diseases
with respect to certain licensed technology and has the right to develop the licensed technology directly or enter into co-development
agreements with partners who can help bring such technology to market. The Factor L&C Agreement also provides for certain services
and materials to be provided by Factor Bioscience to facilitate the development of the licensed technology and to enable the Company
to scale up production at third party facilities.
The
initial term of the Factor L&C Agreement is one year after the effective date, and it automatically renews yearly thereafter. The
Company may terminate the Factor L&C Agreement for any reason upon 90 days’ written notice to Factor Bioscience, and the parties
otherwise have customary termination rights, including in connection with certain uncured material breaches and specified bankruptcy
events.
Pursuant
to the Factor L&C Agreement, the Company will pay Factor Bioscience approximately $0.2 million per month for the first twelve months,
approximately $0.1 million per month for the first nine months toward patent costs, certain milestone payments, royalty payments on net
sales of commercialized products and sublicensing fee payments.
Exacis
Asset Acquisition
On
April 26, 2023, the Company closed the Exacis Acquisition. See Note 3 for additional information.
The
Exacis Acquisition was deemed a related party transaction because, at the time of the acquisition, (i) Dr. Gregory Fiore was both the
chief executive officer of Exacis and a member of the Company’s board of directors, (ii) Dr. Angel was both the Company’s
chief executive officer and chairman of Exacis’ scientific advisory board, and (iii) an affiliate of Factor Bioscience was the
majority stockholder of Exacis.
Consulting
Agreement with Former Director
In
May 2023, the Company entered into a consulting agreement with Dr. Fiore, whereby Dr. Fiore agreed to provide business development consulting
services to the Company for a monthly retainer of $20,000. The consulting agreement was terminable for any reason by either party upon
15 days’ written notice. The Company terminated the consulting agreement, effective July 31, 2023. Dr. Fiore served on the Company’s
board of directors from June 2022 to October 4, 2023.
July
2023, December 2023 and September 2024 Financings
Investors
in the July 2023 convertible note financing included Brant Binder, Richard Wagner, Charles Cherington and Nicholas Singer, and investors
in the December 2023 convertible note financing and the September 2024 financing included Messrs. Cherington and Singer. Each of them
participated in the applicable financing under the same terms and subject to the same conditions as all the other investors. See Note
5 and Note 17 for additional information regarding the financings. Mr. Binder served on the Company’s board of directors from July
6, 2023 to August 8, 2023, Mr. Wagner served on the Company’s board of directors from July 6, 2023 to August 8, 2023, Mr. Cherington
served on the Company’s board of directors from March 2021 to July 6, 2023, and Mr. Singer served on the Company’s board
of directors from June 2022 to July 6, 2023.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.3
COMMITMENTS AND CONTINGENCIES
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
11) | COMMITMENTS
AND CONTINGENCIES |
Litigation
Matters
The
Company is involved in litigation and arbitrations from time to time in the ordinary course of business. Legal fees and other costs associated
with such actions are expensed as incurred. In addition, the Company assesses the need to record a liability for litigation and contingencies.
The Company reserves for costs relating to these matters when a loss is probable, and the amount can be reasonably estimated.
Novellus,
Inc. v. Sowyrda et al., C.A. No. 2184CV02436-BLS2
On
October 25, 2021 Novellus, Inc. filed a complaint in the Superior Court of Massachusetts, Suffolk County, against former Novellus, Inc.
employees Paul Sowyrda and John Westman and certain other former investors in Novellus LLC (Novellus, Inc.’s former parent company
prior to our acquisition of Novellus, Inc.), alleging breach of fiduciary duty, breach of contract and civil conspiracy. Eterna acquired
Novellus, Inc. on July 16, 2021. On May 27, 2022 Novellus, Inc. amended the complaint to withdraw all claims against all defendants except
Paul Sowyrda and John Westman. On July 1, 2022, Westman filed a motion to compel arbitration or in the alternative, to stay the litigation
pending the disposition of certain litigation in the Court of Chancery for the State of Delaware filed by Mr. Sowyrda against Novellus
LLC, Dr. Christopher Rohde, Dr. Matthew Angel, Leonard Mazur and Factor Bioscience, Inc. captioned Zelickson et al., v. Angel et al.,
C.A. 2021-1014-JRS and by Westman against Novellus LLC captioned Westman v. Novellus LLC, C.A. No. 2021-0882-NAC (together,
the “Delaware Actions”). On July 1, 2022, Sowyrda answered the complaint and asserted counterclaims against Novellus, Inc,
and third-party defendants Dr. Matthew Angel and Dr. Christopher Rohde alleging violations of the Massachusetts Wage Act, Massachusetts
Minimum Fair Wage Law, the Fair Labor Standards Act, breach of contract, unjust enrichment and quantum meruit. Sowyrda also joined in
Westman’s motion to stay the case pending the Delaware Actions. Novellus, Inc.’s claims and Mr. Sowyrda’s counterclaims
relate to alleged conduct that took place before Eterna acquired Novellus, Inc.
On
November 15, 2022, prior to a decision on Westman’s and Sowyrda’s motion to compel or stay, the parties agreed to voluntarily
dismiss and consolidate the Delaware Actions with this action. On December 15, 2022, Sowyrda filed an Amended Answer to the Amended Complaint,
asserted affirmative defenses and filed Amended Counterclaims against Dr. Angel, Dr. Rohde, Novellus LLC, Novellus Inc., Factor Bioscience
Inc., and Eterna Therapeutics Inc. (collectively, the “Counterclaim Defendants”) alleging against various Counterclaim Defendants
breach of contract, breaches of the implied duty of good faith and fair dealing, breaches of fiduciary duty, breaches of the operating
agreement, aiding and abetting breaches of fiduciary duty, tortious interference with contract, equitable accounting, violations of the
Massachusetts Wage Act, Massachusetts Minimum Fair Wage Law, the Fair Labor Standards Act, unjust enrichment, and quantum meruit. Also
on December 15, 2022, Westman filed an answer to the Amended Complaint and asserted similar counterclaims against the same Counterclaim
Defendants. Westman and Sowyrda each asserted claims for indemnification and/or advancement against Novellus, Inc. On January 11, 2023,
Westman and Sowyrda served a joint motion to enforce their advancement and/or indemnification rights against Novellus Inc. Novellus Inc.
vigorously opposes this motion and served its opposition on January 27, 2023. On February 8, 2023, Westman and Sowyrda served a reply
in support of their motion to enforce indemnification/advancement rights, and submitted the motion to the Court. Novellus Inc. answered
Westman and Sowyrda’s counterclaims on January 27, 2023, denying liability. The remaining Counterclaim Defendants served a motion
to dismiss most of the remaining counterclaims on January 27, 2023. The Court entered an order granting the Counterclaim Defendants’
motion to dismiss and denying Sowyrda and Westman’s motion to enforce on June 15, 2023. The Court’s order dismissed all of
Westman’s claims against Counterclaim Defendants except his claim for indemnification, and all of Sowyrda’s claims except
his claim for indemnification and his employment-related claims, which Counterclaim Defendants did not move to dismiss. On July 6, 2023,
Westman and Sowyrda filed a petition for interlocutory review with a single justice of the Massachusetts Appeals Court, seeking to overturn
the judge’s decision granting the Counterclaim Defendants’ motion to dismiss most of the remaining counterclaims, but not
the decision denying Westman and Sowyrda’s motion to enforce advancement rights. On July 25, 2023, the parties to the appeal filed
a joint motion to the single justice in the appellate court to stay the appeal to allow for amended counterclaims to be filed by Counterclaim
Plaintiffs and a motion to dismiss to be filed by Counterclaim Defendants. Counterclaim Plaintiffs filed an initial set of amended counterclaims
on August 15, 2023. Counterclaim Plaintiffs amended and refiled their amended counterclaims on September 29, 2023. Counterclaim Defendants
served their motion to dismiss all of the amended counterclaims, except for Sowyrda’s employment-related claims, on October 13,
2023. On June 13, 2024, the motion to dismiss was denied and the court set a schedule for discovery limited to a threshold factual issue.
Discovery as to all other issues pertaining to the counterclaims was stayed. On July 15, 2024, Westman and Sowyrda requested that the
single justice in the appellate court continue to stay the appeal pending the outcome of the limited discovery ordered by the Court.
On July 31, 2024, Counterclaim Defendants and Sowyrda informed the Court that they had reached a settlement and requested that all claims
pending between them be dismissed with prejudice, and on August 9, 2024, the Court approved the motion for approval of dismissal of all
such claims with prejudice. Pursuant to the Court’s order, Counterclaim Defendants are engaged in limited discovery with Westman..
The next Court conference is scheduled for November 18, 2024.
Under
applicable Delaware law and Novellus Inc.’s organizational documents, the Company may be required to advance or reimburse certain
legal expenses incurred by former officers and directors of Novellus, Inc. in connection with the foregoing Westman and Sowyrda matters.
However, a future advance or reimbursement is not currently probable nor can it be reasonably estimated.
eTheRNA
Immunotherapies NV and eTheRNA Inc. v. Eterna Therapeutics Inc. C.A. No. 123CV11732
On
July 31, 2023, eTheRNA Immunotherapies NV and eTheRNA Inc. filed a complaint against the Company alleging the following claims: (1) federal
trademark infringement; (2) federal unfair competition; (3) Massachusetts state common law trademark infringement; (4) Massachusetts
state unfair competition. On April 2, 2024, the parties settled the claims and stipulated to dismiss the complaint with prejudice. Per
the settlement agreement entered into between the parties on March 19, 2024, the Company plans to phase-out its current use of the ETERNA
trademark by October 31, 2024.
On
October 6, 2024, the parties entered into an addendum to the settlement agreement extending the deadline for phasing out the Company’s
use of the ETERNA trademark until March 31, 2025. If the Company continues to use the Eterna Therapeutics name as of April 1, 2025, it
will be obligated to pay €667 per day that it continues to do so.
Licensing
Agreements
On
September 24, 2024, the Company entered into the Factor L&C Agreement. See Note 10 for details of this agreement.
Retirement
Savings Plan
The
Company established a defined contribution plan, organized under Section 401(k) of the Internal Revenue Code, which allows employees
to defer up to 90% of their pay on a pre-tax basis. Beginning on January 1, 2023, the Company began matching employees’ contributions
at a rate of 100% of the first 3% of the employee’s contribution and 50% of the next 2% of the employee’s contribution, for
a maximum Company match of 4%.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.3
STOCK-BASED COMPENSATION
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
12) | STOCK-BASED
COMPENSATION |
Stock
Options
During
the nine months ended September 30, 2024 and 2023, the Company granted options to purchase the number of shares of the Company’s
common stock set forth in the table below (in thousands):
SCHEDULE
OF STOCK OPTION GRANTED
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Stock options granted | |
| 2,375 | | |
| 237 | |
There
were no stock options granted during either of the three months ended September 30, 2024 or 2023.
On
January 1, 2024, Sanjeev Luther was appointed as President, Chief Executive Officer and a director of the Company. Upon his appointment,
he was granted a non-qualified stock option to purchase approximately 1,685,000 shares of the Company’s common stock. The stock
option has an exercise price of $1.80 per share, which was equal to the fair market value (as defined in the 2020 Restated Equity Incentive
Plan) of the Company’s common stock on the date of grant, will vest over four years, with 25% of the shares vesting on the first
anniversary of the grant date and the remaining 75% of the shares vesting in equal monthly installments over the three years thereafter,
in each case, subject to continued service. The stock option was granted pursuant to the terms of Mr. Luther’s employment agreement
and as a material inducement to his joining the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
On
April 26, 2024, the vesting terms of Mr. Luther’s stock option award were amended so that the option vests over three years,
with 25% of the shares vesting on the first anniversary of the grant date and the remaining 75% of the shares will vest in equal monthly
installments over the remaining two years, in each case, subject to continued service.
Since
the only modification to Mr. Luther’s stock option award was to the vesting terms, there was no change to the fair value of the
stock option and the total compensation cost was unchanged. However, the total compensation cost will be recognized over three years
rather than four years, and as a result, the Company recognized approximately $0.1 million in additional stock-based compensation expense
during the nine months ended September 30, 2024 as a result of the modification.
The
Company recognizes stock-based compensation expense for stock options granted to employees, directors and certain consultants. The Company
estimates the fair value of stock options using the Black-Scholes option pricing model. The fair value of stock options granted is recognized
as expense over the requisite service period on a straight-lined basis.
The
following weighted-average assumptions were used for stock options granted during the nine months ended September 30, 2024 and 2023:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS USED FOR STOCK OPTIONS GRANTED
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Weighted average risk-free rate | |
| 4.45 | % | |
| 3.82 | % |
Weighted average volatility | |
| 97.91 | % | |
| 95.15 | % |
Dividend yield | |
| 0.00 | % | |
| 0 | % |
Expected term | |
| 5.85 years | | |
| 5.44 years | |
The
per-share weighted average grant-date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 were
as follows:
SCHEDULE
OF WEIGHTED AVERAGE GRANT-DATE FAIR VALUE OF STOCK OPTIONS
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Weighted average grant date fair value | |
$ | 1.44 | | |
$ | 2.99 | |
Vesting
of all stock options is subject to continuous service with the Company through the applicable vesting date. As of September 30, 2024,
there were approximately 2,516,000 shares of the Company’s common stock subject to outstanding stock options.
Restricted
Stock Units
The
Company recognizes the fair value of RSUs as expense on a straight-line basis over the requisite service period. For performance-based
RSUs, the Company begins recognizing the expense once the achievement of the related performance goal is determined to be probable.
Outstanding
RSUs are settled in an equal number of shares of common stock on the vesting date of the award. An RSU award is settled only to the extent
vested. Vesting generally requires the continued employment or service by the award recipient through the applicable vesting date. Because
RSUs are settled in an equal number of shares of common stock without any offsetting payment by the recipient, the measurement of cost
is based on the quoted market price of the stock at the measurement date, which is the grant date.
In
lieu of paying cash to satisfy withholding taxes due upon the settlement of vested RSUs, at the Company’s discretion, an employee
may elect to have shares of common stock withheld that would otherwise be issued at settlement, the value of which is equal to the amount
of withholding taxes payable. During the three and nine months ended September 30, 2024 and 2023, less than 1,000 RSUs vested. As of
September 30, 2024, there were less than 1,000 RSUs outstanding.
The
Company did not grant RSUs during either of the three or nine months ended September 30, 2024 and 2023.
Stock-Based
Compensation Expense
For
the three and nine months ended September 30, 2024 and 2023, the Company recognized stock-based compensation expense as follows (in thousands):
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
| |
| | |
| | |
| | |
| |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 13 | | |
$ | 57 | | |
$ | 74 | | |
$ | 177 | |
General and administrative | |
| 392 | | |
| 117 | | |
| 1,036 | | |
| 900 | |
Total | |
$ | 405 | | |
$ | 174 | | |
$ | 1,110 | | |
$ | 1,077 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.3
WARRANTS
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
WARRANTS |
As
discussed in Notes
5 and 6, respectively, the Company has previously issued the note warrants and the Q1-22 warrants. The Company also has the December
2022 warrants outstanding from a private placement completed in the fourth quarter of 2022.
As
of September 30, 2024, the Company has the following warrants outstanding:
SCHEDULE
OF WARRANTS OUTSTANDING
| |
Warrants Outstanding (in thousands) | | |
Exercise Price | | |
Expiration Date | |
Classification |
Q1-22 warrants | |
| 343 | | |
$ | 38.20 | | |
September 9, 2027 | |
Liability |
December 2022 Warrants | |
| 4,370 | | |
$ | 1.43 | | |
June 2, 2028 | |
Equity |
July 2023 Note Warrants | |
| 6,094 | | |
$ | 1.43 | | |
July 14, 2028 | |
Equity |
December 2023 Note Warrant issued December 15, 2023 | |
| 8,115 | | |
$ | 1.43 | | |
December 15, 2028 | |
Equity |
December 2023 Note Warrant issued January 11, 2024 | |
| 1,464 | | |
$ | 1.43 | | |
January 11, 2029 | |
Equity |
| |
| 20,386 | | |
| | | |
| |
|
As
of September 30, 2024, the weighted average remaining contractual life of the warrants outstanding was 3.95 years and the weighted average
exercise price was $2.05.
On
October 29, 2024, all of the warrants except for the Q1-22 warrants and approximately 142,000 of the December 2022 Warrants were exchanged
for common stock at a rate of one-half share of common stock for every one warrant share pursuant to the Exchange Transactions. See Note
5 and 17 for more information regarding the Exchange Transactions.
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v3.24.3
NET LOSS PER SHARE
|
9 Months Ended |
Sep. 30, 2024 |
Earnings Per Share [Abstract] |
|
NET LOSS PER SHARE |
The
Company calculates basic and diluted net loss per share attributable to common stockholders in conformity with the two-class method required
for participating securities. The convertible notes contractually entitle the holders thereof to participate in dividends but does not
contractually require the holders to participate in the Company’s losses. As such, the two-class method is not applicable during
periods with a net loss.
Basic
net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of
common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is
calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding
plus dilutive securities. Shares of common stock issuable upon exercise, conversion or vesting of outstanding stock options, RSUs, warrants
and shares of Series A convertible preferred stock are considered potential shares of common stock and are included in the calculation
of diluted net loss per share using the treasury method when their effect is dilutive. The outstanding convertible notes are also considered
potential shares of common stock and are included in the calculation of diluted net loss per share using the “if-converted”
method, and the more dilutive of either the two-class method or the if-converted method is reported. Diluted net loss per share is the
same as basic net loss per share for periods in which the effect of potentially dilutive shares of common stock is antidilutive.
The
following table presents the number of shares subject to outstanding warrants, stock options, RSUs, Series A convertible preferred stock
and convertible notes that were excluded from the computation of diluted net loss per share of common stock for the three and nine months
ended September 30, 2024 and 2023, as their effect was anti-dilutive (in thousands):
SCHEDULE OF COMPUTATION OF DILUTED
NET LOSS PER SHARE OF COMMON STOCK
| |
Three and nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 20,386 | | |
| 10,807 | |
Convertible Notes converted into common stock | |
| 16,106 | | |
| 3,087 | |
Stock options | |
| 2,516 | | |
| 510 | |
Preferred stock converted into common stock | |
| 31 | | |
| 12 | |
RSUs | |
| - | | |
| 1 | |
Total potential common shares excluded from computation | |
| 39,039 | | |
| 14,417 | |
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v3.24.3
STANDBY EQUITY PURCHASE AGREEMENT
|
9 Months Ended |
Sep. 30, 2024 |
Standby Equity Purchase Agreement |
|
STANDBY EQUITY PURCHASE AGREEMENT |
15) | STANDBY
EQUITY PURCHASE AGREEMENT |
On
April 5, 2023, the Company entered into the ELOC with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $10.0
million of the Company’s common stock, subject to the terms and conditions contained in the appliable agreements. Such sales of
common stock by the Company, if any, are subject to certain limitations set forth in the purchase agreement, and may occur from time
to time, at the Company’s sole discretion, over a period of up to 24-months, commencing April 25, 2023, which was the date on which
each of the conditions to Lincoln Park’s purchase obligations set forth in the purchase agreement were initially satisfied. In
consideration of Lincoln Park’s entry into the purchase agreement, the Company issued to Lincoln Park approximately 74,000 shares
of common stock as commitment shares. The value of the commitment shares was recorded as a period expense and included in other expense,
net, in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2023.
In
April 2023, the Company filed a registration statement on Form S-1 to register the sale from time to time of up
to 2,930,237 shares of the Company’s common stock by Lincoln Park, including the approximately 74,000 commitment shares, which
was declared effective on April 24, 2023 (the “ELOC S-1”).
During
the three and nine months ended September 30, 2023, the Company issued and sold approximately 214,000 shares of common stock under the
ELOC, including the approximately 74,000 commitment shares, for gross proceeds of $0.3 million. No shares were sold under the ELOC
during the three or nine months ended September 30, 2024. As of September 30, 2024, there were approximately 2,716,000 shares remaining
to be sold under the ELOC that are registered for resale by Lincoln Park under the ELOC S-1.
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v3.24.3
SUBSEQUENT EVENT
|
9 Months Ended |
Sep. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENT |
As
discussed in Note 5, on September 24, 2024, the Company entered into the September 2024 Transactions. On October 29, 2024, the Company
held its Annual Meeting, whereby the Company’s stockholders approved the September 2024 Transactions, and as a result, the following
occurred:
|
● |
Under
the Common Stock Private Placement, the Company issued approximately 1,402,000 shares of common stock and pre-funded warrants to
purchase 115,000 shares of common stock and received approximately $1.1 million in gross proceeds from the issuance of such securities.
The pre-funded warrants have an exercise price of $0.005 per share, are exercisable at any time and will not expire
until exercised in full. |
|
|
|
|
● |
Under
the Bridge Notes, approximately $3.0 million of the principal amount of the bridge notes plus all accrued and unpaid interest thereon,
plus such amount of interest that would have accrued on the principal amount through December 24, 2024, was automatically converted
at a conversion price of $0.50 into approximately 6,244,000 shares of the Company’s common stock and approximately $0.9 million
of the principal amount of the bridge notes plus all accrued and unpaid interest thereon, plus such amount of interest that would
have accrued on the principal amount through December 24, 2024, was automatically converted at a conversion price of $0.50 into pre-funded
warrants to purchase 1,764,000 shares of common stock. The pre-funded warrants have an exercise price of $0.005 per share, are exercisable at any time and will not expire until exercised in full. |
|
|
|
|
● |
Under
the Exchange Transactions, (i) the holders of the warrants exchanged approximately 19,902,000 warrants for approximately 9,951,000
shares of the Company’s common stock at an exchange ratio of one-half of a share of common stock for every one share of common
stock issuable upon exercise of the applicable warrant (rounded up to the nearest whole number), and (ii) the holders of the
convertible notes exchanged all their convertible notes for approximately 28,351,000 shares of the Company’s common stock at an exchange ratio
equal to (A) the sum expressed in U.S. dollars of (1) the principal amount of the applicable convertible note, plus (2) all accrued
and unpaid interest thereon through the date the applicable convertible note is exchanged plus (3) all interest that would have
accrued through, but not including, the maturity date of applicable convertible note if it was outstanding from the date such
convertible note is exchanged through its maturity date, divided by (B) $1.00
(rounded up to the nearest whole number). The Company issued approximately 38,302,000
shares of our common stock at the closing of the Exchange Transactions. |
In total, the Company issued
approximately 45.9 million shares of common stock and 1.9 million pre-funded warrants on October 29, 2024 pursuant to the September
24, 2024 Transactions and had 51.4 million shares of common stock issued and outstanding.
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- DefinitionTabular disclosure of asset acquisition.
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v3.24.3
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE |
The
following tables summarize the liabilities that are measured at fair value as of September 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE
Description | |
Level | | |
September 30, 2024 | | |
December 31, 2023 | |
Liabilities: | |
| | | |
| | | |
| | |
Warrant liabilities - Q1-22 warrants | |
| 3 | | |
$ | 15 | | |
$ | 116 | |
Warrant liabilities – Exchange Transactions | |
| 3 | | |
$ | 10,448 | | |
$ | - | |
Bridge Notes derivative liability | |
| 3 | | |
$ | 4,926 | | |
$ | - | |
Market Cap Contingent Consideration | |
| | | |
| - | | |
| - | |
Liability fair value disclosure | |
| | | |
| - | | |
| - | |
|
SCHEDULE OF CHANGES IN WARRANT LIABILITIES |
The
following table presents the changes in the liabilities measured at fair value from January 1, 2024 through September 30, 2024 (in thousands):
SCHEDULE
OF CHANGES IN WARRANT LIABILITIES
| |
Warrant Liabilities | |
|
Derivative
Liability |
| |
Contingent Consideration | |
| |
| |
|
|
| |
| |
Fair value at January 1, 2024 | |
$ | 116 | |
|
$ |
- |
| |
$ | 107 | |
Reclassification of warrants from equity to liability | |
| 11,244 | |
|
|
- |
| |
| - | |
Initial measurement of Bridge Notes derivative liability | |
| - | |
|
|
5,566 |
| |
| - | |
Change in fair value | |
| (897 | ) |
|
|
(640 |
) | |
| (66 | ) |
Fair value at September 30, 2024 | |
$ | 10,463 | |
|
$ |
4,926 |
| |
$ | 41 | |
|
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES |
The
table below is provided for comparative purposes only and presents information about the fair value of the Company’s convertible
notes relative to the carrying values recognized in the condensed consolidated balance sheet as of September 30, 2024 and December 31,
2023 (in thousands).
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES
| |
| | |
September 30, 2024 | | |
December 31, 2023 | |
| |
Level | | |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
Convertible Notes | |
| 3 | | |
$ | 32,037 | | |
$ | 29,768 | | |
$ | 16,616 | | |
$ | 17,594 | |
Bridge Notes | |
| 3 | | |
$ | 3,887 | | |
$ | 8,409 | | |
$ | - | | |
$ | - | |
|
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|
v3.24.3
LEASES (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Leases [Abstract] |
|
NET OPERATING LEASE EXPENSE |
For
the three and nine months ended September 30, 2024 and 2023, the net operating lease expenses were as follows (in thousands):
NET
OPERATING LEASE EXPENSE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease expense | |
$ | 1,110 | | |
$ | 1,623 | | |
$ | 4,380 | | |
$ | 1,758 | |
Sublease income | |
| (21 | ) | |
| (21 | ) | |
| (63 | ) | |
| (63 | ) |
Variable lease expense | |
| 225 | | |
| 6 | | |
| 887 | | |
| 18 | |
Total lease expense | |
$ | 1,314 | | |
$ | 1,608 | | |
$ | 5,204 | | |
$ | 1,713 | |
|
OPERATING LEASE RIGHT-OF-USE ASSETS AND LIABILITIES |
The
tables below show the beginning balances of the operating ROU assets and lease liabilities as of January 1, 2024 and the ending balances
as of September 30, 2024, including the changes during the period (in thousands).
OPERATING
LEASE RIGHT-OF-USE ASSETS AND LIABILITIES
| |
Operating Lease ROU Assets | |
| |
| |
Operating lease ROU assets at January 1, 2024 | |
$ | 32,781 | |
Adjustment to ROU asset for remeasurement of | |
| | |
Somerville Sublease liability | |
| 4,245 | |
Write-off of Somerville Sublease ROU asset | |
| (34,857 | ) |
Amortization of operating lease ROU assets | |
| (1,450 | ) |
Operating lease ROU assets at September 30, 2024 | |
$ | 719 | |
| |
Operating Lease Liabilities | |
Operating lease liabilities at January 1, 2024 | |
$ | 35,070 | |
Adjustment to lease liability due to remeasurement of Somerville Sublease | |
| 4,245 | |
Accretion of interest for Somerville Sublease | |
| 2,465 | |
Write-off of Somerville Sublease liability | |
| (36,924 | ) |
Principal payments on operating lease liabilities | |
| (4,121 | ) |
Operating lease liabilities at September 30, 2024 | |
| 735 | |
Less non-current portion | |
| 534 | |
Current portion at September 30, 2024 | |
$ | 201 | |
|
MATURITIES OF OPERATING LEASE LIABILITIES |
MATURITIES
OF OPERATING LEASE LIABILITIES
| |
As of September 30, 2024 | |
2024 | |
$ | 69 | |
2025 | |
| 274 | |
2026 | |
| 267 | |
2027 | |
| 163 | |
2028 | |
| 82 | |
Total payments | |
| 855 | |
Less imputed interest | |
| (120 | ) |
Total operating lease liabilities | |
$ | 735 | |
|
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v3.24.3
ACCRUED EXPENSES (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES |
Accrued
expenses at September 30, 2024 and December 31, 2023 consisted of the following (in thousands):
SCHEDULE
OF ACCRUED EXPENSES
| |
September 30, 2024 | | |
December 31,
2023 | |
Professional fees | |
$ | 290 | | |
$ | 239 | |
Legal fees | |
| 267 | | |
| 643 | |
Accrued compensation | |
| 108 | | |
| 109 | |
Convertible notes interest | |
| 38 | | |
| 176 | |
Somerville facility | |
| - | | |
| 218 | |
Other | |
| 463 | | |
| 508 | |
Total accrued expenses | |
$ | 1,166 | | |
$ | 1,893 | |
|
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v3.24.3
STOCK-BASED COMPENSATION (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
SCHEDULE OF STOCK OPTION GRANTED |
During
the nine months ended September 30, 2024 and 2023, the Company granted options to purchase the number of shares of the Company’s
common stock set forth in the table below (in thousands):
SCHEDULE
OF STOCK OPTION GRANTED
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Stock options granted | |
| 2,375 | | |
| 237 | |
|
SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS USED FOR STOCK OPTIONS GRANTED |
The
following weighted-average assumptions were used for stock options granted during the nine months ended September 30, 2024 and 2023:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS USED FOR STOCK OPTIONS GRANTED
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Weighted average risk-free rate | |
| 4.45 | % | |
| 3.82 | % |
Weighted average volatility | |
| 97.91 | % | |
| 95.15 | % |
Dividend yield | |
| 0.00 | % | |
| 0 | % |
Expected term | |
| 5.85 years | | |
| 5.44 years | |
|
SCHEDULE OF WEIGHTED AVERAGE GRANT-DATE FAIR VALUE OF STOCK OPTIONS |
The
per-share weighted average grant-date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 were
as follows:
SCHEDULE
OF WEIGHTED AVERAGE GRANT-DATE FAIR VALUE OF STOCK OPTIONS
| |
| | |
| |
| |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Weighted average grant date fair value | |
$ | 1.44 | | |
$ | 2.99 | |
|
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE |
For
the three and nine months ended September 30, 2024 and 2023, the Company recognized stock-based compensation expense as follows (in thousands):
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
| |
| | |
| | |
| | |
| |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 13 | | |
$ | 57 | | |
$ | 74 | | |
$ | 177 | |
General and administrative | |
| 392 | | |
| 117 | | |
| 1,036 | | |
| 900 | |
Total | |
$ | 405 | | |
$ | 174 | | |
$ | 1,110 | | |
$ | 1,077 | |
|
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v3.24.3
WARRANTS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF WARRANTS OUTSTANDING |
As
of September 30, 2024, the Company has the following warrants outstanding:
SCHEDULE
OF WARRANTS OUTSTANDING
| |
Warrants Outstanding (in thousands) | | |
Exercise Price | | |
Expiration Date | |
Classification |
Q1-22 warrants | |
| 343 | | |
$ | 38.20 | | |
September 9, 2027 | |
Liability |
December 2022 Warrants | |
| 4,370 | | |
$ | 1.43 | | |
June 2, 2028 | |
Equity |
July 2023 Note Warrants | |
| 6,094 | | |
$ | 1.43 | | |
July 14, 2028 | |
Equity |
December 2023 Note Warrant issued December 15, 2023 | |
| 8,115 | | |
$ | 1.43 | | |
December 15, 2028 | |
Equity |
December 2023 Note Warrant issued January 11, 2024 | |
| 1,464 | | |
$ | 1.43 | | |
January 11, 2029 | |
Equity |
| |
| 20,386 | | |
| | | |
| |
|
|
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v3.24.3
NET LOSS PER SHARE (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Earnings Per Share [Abstract] |
|
SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE OF COMMON STOCK |
The
following table presents the number of shares subject to outstanding warrants, stock options, RSUs, Series A convertible preferred stock
and convertible notes that were excluded from the computation of diluted net loss per share of common stock for the three and nine months
ended September 30, 2024 and 2023, as their effect was anti-dilutive (in thousands):
SCHEDULE OF COMPUTATION OF DILUTED
NET LOSS PER SHARE OF COMMON STOCK
| |
Three and nine months ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 20,386 | | |
| 10,807 | |
Convertible Notes converted into common stock | |
| 16,106 | | |
| 3,087 | |
Stock options | |
| 2,516 | | |
| 510 | |
Preferred stock converted into common stock | |
| 31 | | |
| 12 | |
RSUs | |
| - | | |
| 1 | |
Total potential common shares excluded from computation | |
| 39,039 | | |
| 14,417 | |
|
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v3.24.3
LIQUIDITY AND CAPITAL RESOURCES (Details Narrative) $ in Thousands |
|
|
|
3 Months Ended |
6 Months Ended |
9 Months Ended |
12 Months Ended |
|
|
|
Oct. 29, 2024
USD ($)
|
Sep. 24, 2024
USD ($)
|
Jan. 11, 2024
USD ($)
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
shares
|
Dec. 31, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
shares
|
Sep. 30, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
shares
|
Aug. 05, 2024
USD ($)
|
Apr. 30, 2023
USD ($)
|
Oct. 31, 2022
USD ($)
ft²
|
Cash |
|
|
|
$ 4,264
|
|
$ 4,264
|
$ 7,575
|
$ 4,264
|
|
$ 7,575
|
|
|
|
Accumulated deficit |
|
|
|
225,769
|
|
$ 225,769
|
186,981
|
225,769
|
|
$ 186,981
|
|
|
|
Net loss |
|
|
|
$ 26,604
|
$ 5,591
|
|
|
38,780
|
$ 15,515
|
|
|
|
|
Net cash used in operating activities |
|
|
|
|
|
|
|
12,291
|
15,747
|
|
|
|
|
Area of premises | ft² |
|
|
|
|
|
|
|
|
|
|
|
|
45,500
|
Letter of credit |
|
|
|
|
|
|
|
|
|
|
$ 4,100
|
|
$ 4,100
|
Restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
$ 4,100
|
Proceeds received from the convertible notes financing |
|
|
|
|
|
|
|
$ 1,405
|
$ 8,715
|
|
|
|
|
Convertible Debt [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds received from the convertible notes financing |
|
$ 3,900
|
$ 1,400
|
|
|
|
$ 16,500
|
|
|
|
|
|
|
Convertible Debt [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds received from the convertible notes financing |
$ 1,100
|
|
|
|
|
|
|
|
|
|
|
|
|
Lincoln Park Capital Fund LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock shares issued and sold (in shares) | shares |
|
|
|
|
|
0
|
|
0
|
|
214,000
|
|
|
|
Gross proceeds from sale of equity |
|
|
|
|
|
|
|
|
|
$ 300
|
|
|
|
Lincoln Park Capital Fund LLC [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate gross purchase price |
|
|
|
|
|
|
|
|
|
|
|
$ 10,000
|
|
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ASSET ACQUISITION (Details Narrative) $ in Millions |
Apr. 26, 2023
USD ($)
shares
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Allocated percentage of fair value of consideration to purchased license |
100.00%
|
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Stock Issued During Period, Shares, Acquisitions | shares |
69,000
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12 months
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$ 75.0
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3.00
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Minimum market capitalization requirement, amount |
$ 100.0
|
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Minimum market capitalization requirement, amount |
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v3.24.3
CONTRACT WITH CUSTOMER (Details Narrative) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
|
Aug. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 24, 2024 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Proceeds from option and license agreement |
$ 300,000
|
|
|
|
|
|
Proceeds from cell line customization activities |
$ 400,000
|
|
|
|
|
|
Performance obligation, percentage |
|
100.00%
|
|
100.00%
|
|
|
Revenue recognized in previous periods |
|
|
|
$ 0
|
|
|
Catch-up adjustment to revenue |
|
|
|
0
|
|
|
Revenue recognized |
|
$ 200,000
|
$ 100,000
|
$ 200,000
|
$ 100,000
|
|
Option fee obligation payment percentage |
|
|
|
20.00%
|
|
|
License fees |
|
0
|
$ 100,000
|
$ 0
|
$ 100,000
|
|
Transferred over Time [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Revenue recognized |
|
|
|
400,000
|
|
|
Lineage Assignment Agreement [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Payments, percentage |
|
|
|
|
|
30.00%
|
Option right payments |
|
$ 300,000
|
|
$ 300,000
|
|
|
Lineage Assignment Agreement [Member] | Factor Bioscience Limited [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Payments, percentage |
|
|
|
|
|
20.00%
|
X |
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v3.24.3
CONVERTIBLE NOTES FINANCINGS, BRIDGE FINANCING, EXCHANGE TRANSACTION AND EQUITY FINANCING (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
|
|
|
1 Months Ended |
2 Months Ended |
3 Months Ended |
6 Months Ended |
9 Months Ended |
|
|
Oct. 29, 2024 |
Sep. 30, 2024 |
Sep. 24, 2024 |
Jan. 11, 2024 |
Jul. 14, 2023 |
Jul. 31, 2023 |
Dec. 24, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 15, 2023 |
Dec. 14, 2023 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ 32,037
|
|
|
|
|
|
$ 32,037
|
|
$ 6,773
|
$ 32,037
|
|
|
|
Common stock per share |
|
$ 0.005
|
|
|
|
|
|
$ 0.005
|
|
$ 0.005
|
$ 0.005
|
|
|
|
Convertible notes |
|
|
|
|
|
|
|
|
|
|
$ 1,405
|
$ 8,715
|
|
|
Fair value of reacquired convertible notes |
|
|
|
|
|
|
|
|
$ 5,113
|
|
|
5,113
|
|
|
Loss on extinguishment of debt |
|
|
|
|
|
|
|
$ (22,440)
|
|
|
(22,440)
|
|
|
|
Reclassification of warrants |
|
|
|
|
|
|
|
11,244
|
|
|
11,244
|
|
|
|
Warrant liabilities |
|
|
|
|
|
|
|
(831)
|
(20)
|
|
(897)
|
(166)
|
|
|
Additional paid-in capital |
|
$ 180,348
|
$ 600
|
|
|
|
|
180,348
|
|
$ 189,186
|
180,348
|
|
|
|
Loss |
|
|
|
|
|
|
|
(26,604)
|
(5,591)
|
|
(38,780)
|
(15,515)
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
19,902,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
28,351,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
38,302,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
9,951,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible Debt [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
10.00%
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
$ 3,900
|
$ 1,400
|
|
|
|
|
|
$ 16,500
|
|
|
|
|
Convertible Debt [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
$ 1,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt conversion |
|
|
$ 1.00
|
|
|
|
|
|
|
|
|
|
|
|
Warrants purchase |
|
|
4,400,000
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 1.43
|
|
|
|
|
|
|
|
|
|
|
|
Common stock per share |
|
|
$ 0.5
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
$ 28,400
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
10,100
|
|
|
|
|
|
|
|
|
|
|
|
principal and accrued interest |
|
|
19,400
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized debt issuance costs |
|
|
9,300
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of reacquired convertible notes |
|
|
$ 32,000
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
28,351,000
|
|
|
|
|
|
|
|
|
|
|
|
Sale of Stock, Price Per Share |
|
|
$ 1.13
|
|
|
|
|
|
|
|
|
|
|
|
Loss on extinguishment of debt |
|
|
$ 21,900
|
|
|
|
|
21,900
|
|
|
21,900
|
|
|
|
Reclassification of warrants |
|
|
$ 11,200
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liabilities |
|
800
|
|
|
|
|
|
800
|
|
|
800
|
|
|
|
Exchange Agreements [Member] | December 2022 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants purchase |
|
|
100,000
|
|
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock per share |
|
|
$ 0.745
|
|
|
|
|
|
|
|
|
|
|
|
Sale of Stock, Price Per Share |
|
|
$ 0.75
|
|
|
|
|
|
|
|
|
|
|
|
Loss on extinguishment of debt |
|
|
$ 21,900
|
|
|
|
|
|
|
|
|
|
|
|
Sale of Stock, Number of Shares Issued in Transaction |
|
|
1,517,000
|
|
|
|
|
|
|
|
|
|
|
|
Loss on extinguishment of debt |
|
|
$ 600
|
|
|
|
|
|
|
|
|
|
|
|
Loss |
|
|
|
|
|
|
|
22,400
|
|
|
$ 22,400
|
|
|
|
Private Placement [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
115,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 0.005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
1,402,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross proceeds |
$ 1,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible Debt [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bridge Notes mature period |
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
Repurchase price percentage |
|
|
|
|
|
|
|
|
|
|
100.00%
|
|
|
|
Bridge Debt [Member] | Private Placement [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principle amount |
|
|
$ 3,900
|
|
|
|
|
|
|
|
|
|
|
|
Bridge Notes mature period |
|
|
1 year
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase price percentage |
|
|
|
|
|
|
|
|
|
|
10000.00%
|
|
|
|
Debt conversion |
|
|
|
|
|
|
|
|
|
|
$ 0.50
|
|
|
|
Derivative liabilities |
|
5,500
|
|
|
|
|
|
5,500
|
|
|
$ 5,500
|
|
|
|
Reduction in carrying amount |
|
|
|
|
|
|
|
|
|
|
3,900
|
|
|
|
Incremental fair value expenses |
|
|
|
|
|
|
|
|
|
|
1,600
|
|
|
|
Fair value remeasurement |
|
$ 600
|
|
|
|
|
|
600
|
|
|
600
|
|
|
|
Derivative liabilities |
|
|
|
|
|
|
|
1,600
|
|
|
1,600
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of reacquired convertible notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
|
|
|
|
|
|
|
|
|
214,000
|
|
|
Common Stock [Member] | Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principle amount |
|
|
|
|
|
|
$ 3,000
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
$ 0.50
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
|
|
|
|
6,244,000
|
|
|
|
|
|
|
|
Prefunded Warrants [Member] | Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principle amount |
|
|
|
|
|
|
$ 900
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
|
|
|
|
1,764,000
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
$ 0.50
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
$ 0.005
|
|
|
|
|
|
|
|
July 2023 Note Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
|
|
6,100,000
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
$ 1.43
|
|
|
|
|
|
$ 1.43
|
|
|
$ 1.43
|
|
|
|
July 2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
|
|
$ 8,700
|
|
|
|
|
|
|
|
|
|
Principle amount |
|
|
|
|
8,700
|
|
|
|
|
|
|
|
|
|
Transaction fees |
|
|
|
|
$ 200
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
|
6.00%
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
$ 2.86
|
|
|
|
|
|
|
|
|
December 2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
|
1,400
|
|
|
|
|
|
|
|
|
$ 7,800
|
|
Principle amount |
|
|
|
$ 1,400
|
|
|
|
|
|
|
|
|
$ 7,800
|
$ 9,200
|
Issuance of shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
9,600,000
|
Interest rate |
|
|
|
|
|
|
|
|
|
12.00%
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
|
|
|
$ 1.9194
|
|
|
|
|
December 2023 Convertible Notes [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
|
1,500,000
|
|
|
|
|
|
|
|
|
8,100,000
|
|
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v3.24.3
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Warrant Liabilities Exchange Transactions [Member] |
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
|
Liability fair value disclosure |
$ 10,448
|
|
Bridge Notes Derivative Liability [Member] |
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
|
Liability fair value disclosure |
4,926
|
|
Market Cap Contingent Consideration [Member] |
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
|
Liability fair value disclosure |
|
|
Q1-22 Warrants [Member] | Derivative Financial Instruments, Liabilities [Member] |
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
|
Liability fair value disclosure |
$ 15
|
$ 116
|
X |
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SCHEDULE OF CHANGES IN WARRANT LIABILITIES (Details) $ in Thousands |
9 Months Ended |
Sep. 30, 2024
USD ($)
|
Warrant Liabilities [Member] |
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
Fair value at January 1, 2024 |
$ 116
|
Reclassification of warrants from equity to liability |
11,244
|
Initial measurement of Bridge Notes derivative liability |
|
Change in fair value |
(897)
|
Fair value at September 30, 2024 |
10,463
|
Derivative Financial Instruments, Liabilities [Member] |
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
Fair value at January 1, 2024 |
|
Reclassification of warrants from equity to liability |
|
Initial measurement of Bridge Notes derivative liability |
5,566
|
Change in fair value |
(640)
|
Fair value at September 30, 2024 |
4,926
|
Contingent Consideration [Member] |
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
Fair value at January 1, 2024 |
107
|
Reclassification of warrants from equity to liability |
|
Initial measurement of Bridge Notes derivative liability |
|
Change in fair value |
(66)
|
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$ 41
|
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SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Reported Value Measurement [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Convertible debt |
$ 32,037
|
$ 16,616
|
Bridge notes |
3,887
|
|
Estimate of Fair Value Measurement [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Convertible debt |
29,768
|
17,594
|
Bridge notes |
$ 8,409
|
|
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v3.24.3
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
3 Months Ended |
9 Months Ended |
|
|
Sep. 24, 2024 |
Sep. 30, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Oct. 29, 2024 |
Mar. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
|
Reclassification of warrants |
|
$ 11,244
|
$ 11,244
|
|
|
|
Fair value of warrants |
|
600
|
|
|
|
|
Stock Issued During Period, Value, New Issues |
|
|
|
$ 580
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
|
Reclassification of warrants |
|
|
|
|
|
|
Stock Issued During Period, Value, New Issues |
|
|
8,000
|
$ 1
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
|
Stock price |
|
|
|
|
$ 1.05
|
|
Convertible Notes [Member] |
|
|
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
|
Stock Issued During Period, Value, New Issues |
|
|
$ 28,400
|
|
|
|
Exchange Agreements [Member] |
|
|
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
|
Stock price |
$ 1.13
|
|
|
|
|
|
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$ 11,200
|
|
|
|
|
|
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|
|
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
|
Private placement shares |
|
|
|
|
|
343,000
|
X |
- DefinitionNumber of shares authorized to be purchased under share repurchase plan. Includes, but is not limited to, repurchase of stock and unit of ownership.
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NET OPERATING LEASE EXPENSE (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Leases [Abstract] |
|
|
|
|
Operating lease expense |
$ 1,110
|
$ 1,623
|
$ 4,380
|
$ 1,758
|
Sublease income |
(21)
|
(21)
|
(63)
|
(63)
|
Variable lease expense |
225
|
6
|
887
|
18
|
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$ 1,314
|
$ 1,608
|
$ 5,204
|
$ 1,713
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v3.24.3
OPERATING LEASE RIGHT-OF-USE ASSETS AND LIABILITIES (Details) - USD ($) $ in Thousands |
9 Months Ended |
|
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Leases [Abstract] |
|
|
|
Operating lease ROU assets, Beginning |
$ 32,781
|
|
|
Adjustment to ROU asset for remeasurement of Somerville Sublease liability |
4,245
|
|
|
Write-off Sublease lease ROU assets |
(34,857)
|
|
|
Amortization of operating lease ROU assets |
(1,450)
|
$ (580)
|
|
Operating lease ROU assets, Ending |
719
|
|
|
Operating lease liabilities, Beginning |
35,070
|
|
|
Adjustment to lease liablity due to remeasurement of Somerville Sublease |
4,245
|
|
|
Accretion of interest for Somerville Sublease |
2,465
|
|
|
Write-off Sublease liability |
(36,924)
|
|
|
Principal payments on operating lease liabilities |
(4,121)
|
|
|
Operating lease liabilities, Ending |
735
|
|
|
Less non-current portion |
534
|
|
$ 32,854
|
Current portion |
$ 201
|
|
$ 2,216
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v3.24.3
LEASES (Details Narrative)
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
May 03, 2024
USD ($)
|
Oct. 31, 2022
USD ($)
ft²
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Aug. 31, 2024
USD ($)
|
Aug. 05, 2024
USD ($)
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
Area of real estate property | ft² |
|
45,500
|
|
|
|
|
|
Letter of credit |
|
$ 4,100,000
|
|
|
|
|
$ 4,100,000
|
Past due rent amount |
$ 2,300,000
|
|
|
|
|
|
|
Late fees and interest payment due on rent amount |
$ 70,000
|
|
|
|
|
|
|
Rental payments |
|
|
|
|
|
$ 4,000,000.0
|
$ 4,000,000.0
|
Gain on termination of lease |
|
|
|
$ 1,576,000
|
|
|
|
(Gain) loss on disposal of fixed assets |
|
|
|
|
$ (1,000)
|
|
|
Weighted average remaining lease term |
|
|
3 years 3 months 18 days
|
3 years 3 months 18 days
|
|
|
|
Weighted average discount rate |
|
|
10.23%
|
10.23%
|
|
|
|
Sublease Termination Agreement [Member] |
|
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
Gain on termination of lease |
|
|
$ 1,600,000
|
$ 1,600,000
|
|
|
|
(Gain) loss on disposal of fixed assets |
|
|
$ 500,000
|
$ 500,000
|
|
|
|
ER Squibb Sons LLC [Member] |
|
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
Area of real estate property | ft² |
|
45,500
|
|
|
|
|
|
Operating leases monthly base rent |
|
$ 500,000
|
|
|
|
|
|
Letter of credit |
|
$ 4,100,000
|
|
|
|
|
|
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v3.24.3
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
Sep. 24, 2024 |
May 31, 2023 |
Sep. 30, 2022 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Nov. 30, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Research and development expense |
|
|
|
$ 1,001,000
|
$ 1,387,000
|
$ 3,446,000
|
$ 4,560,000
|
|
Director [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Monthly installment fees amount |
|
$ 20,000
|
|
|
|
|
|
|
Nove Cite INC [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Percentage of non-controlling interest |
|
|
|
|
|
|
|
25.00%
|
Factor Bioscience Inc [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Notice period for superseding termination provisions |
|
|
30 days
|
|
|
|
|
|
Master services agreement, initial fees payable |
|
|
$ 5,000,000.0
|
|
|
|
|
|
Number of monthly installments for fees payable |
|
|
12 months
|
|
|
|
|
|
Monthly installment fees amount |
|
|
$ 400,000
|
|
|
|
|
|
Master services agreement fees payable |
|
|
5,000,000.0
|
|
|
|
|
|
Initial license fees obligation |
|
|
3,500,000
|
|
|
|
|
|
Deposit paid to be applied to last month of first work order |
|
|
400,000
|
|
|
|
|
|
Agreed waive payment |
|
|
3,500,000
|
|
|
|
|
|
Research and development expense |
|
|
$ 3,500,000
|
|
|
|
|
|
Factor L& C Agreement [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Notice period for customary termination rights |
90 days
|
|
|
|
|
|
|
|
Factor L& C Agreement [Member] | First Twelve Months [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Costs |
$ 200,000
|
|
|
|
|
|
|
|
Factor L& C Agreement [Member] | First Nine Months [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Costs |
$ 100,000
|
|
|
|
|
|
|
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v3.24.3
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v3.24.3
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
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$ 174
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$ 1,110
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$ 1,077
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13
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57
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74
|
177
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General and Administrative Expense [Member] |
|
|
|
|
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|
|
|
|
Total |
$ 392
|
$ 117
|
$ 1,036
|
$ 900
|
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v3.24.3
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
3 Months Ended |
9 Months Ended |
Apr. 26, 2024 |
Jan. 01, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
$ 405
|
$ 174
|
$ 1,110
|
$ 1,077
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Stock options granted |
|
|
|
|
2,375,000
|
237,000
|
Number of stock option awards outstanding |
|
|
2,516,000
|
|
2,516,000
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
RSUs vested |
|
|
1,000
|
1,000
|
1,000
|
1,000
|
Restricted stock units, outstanding |
|
|
1,000
|
|
1,000
|
|
Sanjeev Luther [Member] | Nonqualified Stock Option [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Stock options granted |
|
1,685,000
|
|
|
|
|
Exercise price |
|
$ 1.80
|
|
|
|
|
Vesting period |
|
4 years
|
|
|
|
|
Frequency of stock vesting installments |
|
monthly
|
|
|
|
|
Sanjeev Luther [Member] | Nonqualified Stock Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Vesting percentage |
|
25.00%
|
|
|
|
|
Sanjeev Luther [Member] | Nonqualified Stock Option [Member] | Share-Based Payment Arrangement, Tranche Two [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Vesting period |
|
3 years
|
|
|
|
|
Vesting percentage |
|
75.00%
|
|
|
|
|
Sanjeev Luther [Member] | Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Vesting period |
3 years
|
|
|
|
|
|
Frequency of stock vesting installments |
monthly
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
|
$ 100
|
|
Sanjeev Luther [Member] | Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Vesting percentage |
25.00%
|
|
|
|
|
|
Sanjeev Luther [Member] | Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche Two [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Vesting percentage |
75.00%
|
|
|
|
|
|
Employee [Member] | Performance Based Restricted Stock Units [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Number of RSUs granted |
|
|
0
|
0
|
0
|
0
|
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v3.24.3
SCHEDULE OF WARRANTS OUTSTANDING (Details) shares in Thousands |
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding |
20,386
|
Q1-22 Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding |
343
|
Exercise Price | $ / shares |
$ 38.20
|
Expiration Date |
Sep. 09, 2027
|
December 2022 Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding |
4,370
|
Exercise Price | $ / shares |
$ 1.43
|
Expiration Date |
Jun. 02, 2028
|
July 2023 Note Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding |
6,094
|
Exercise Price | $ / shares |
$ 1.43
|
Expiration Date |
Jul. 14, 2028
|
December 2023 Note Warrant Issued December 15, 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding |
8,115
|
Exercise Price | $ / shares |
$ 1.43
|
Expiration Date |
Dec. 15, 2028
|
December 2023 Note Warrant Issued January 11, 2024 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding |
1,464
|
Exercise Price | $ / shares |
$ 1.43
|
Expiration Date |
Jan. 11, 2029
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SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE OF COMMON STOCK (Details) - shares shares in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
39,039
|
14,417
|
39,039
|
14,417
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
20,386
|
10,807
|
20,386
|
10,807
|
Convertible Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
16,106
|
3,087
|
16,106
|
3,087
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
2,516
|
510
|
2,516
|
510
|
Convertible Preferred Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
31
|
12
|
31
|
12
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
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|
|
|
|
Total potential common shares excluded from computation |
|
1
|
|
1
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v3.24.3
STANDBY EQUITY PURCHASE AGREEMENT (Details Narrative) - USD ($) $ in Millions |
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
Apr. 05, 2023 |
Apr. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Common Stock [Member] |
|
|
|
|
|
|
Shares issued for purchase agreement |
|
|
|
|
|
69,000
|
Number of shares issued |
|
|
|
|
|
214,000
|
Lincoln Park [Member] | ELOC [Member] |
|
|
|
|
|
|
Common stock shares issued and sold |
|
|
0
|
|
0
|
|
Gross proceeds from sale of equity |
|
|
|
$ 0.3
|
|
$ 0.3
|
Remaining shares to be sold |
|
|
2,716,000
|
|
2,716,000
|
|
Lincoln Park [Member] | ELOC [Member] | Commitment Shares [Member] |
|
|
|
|
|
|
Shares issued for purchase agreement |
74,000
|
74,000
|
|
74,000
|
|
74,000
|
Lincoln Park [Member] | ELOC [Member] | Common Stock [Member] |
|
|
|
|
|
|
Common stock shares issued and sold |
|
|
|
214,000
|
|
214,000
|
Lincoln Park [Member] | Maximum [Member] | Commitment Shares [Member] |
|
|
|
|
|
|
Number of shares issued |
|
2,930,237
|
|
|
|
|
Lincoln Park [Member] | Maximum [Member] | ELOC [Member] |
|
|
|
|
|
|
Aggregate gross purchase price |
$ 10.0
|
|
|
|
|
|
Common stock purchase agreement commencement period |
24 months
|
|
|
|
|
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v3.24.3
SUBSEQUENT EVENT (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
|
2 Months Ended |
9 Months Ended |
|
|
Oct. 29, 2024 |
Dec. 24, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Dec. 31, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
|
Common stock, shares issued |
|
|
|
5,411,000
|
5,410,000
|
Common stock, shares outstanding |
|
|
|
5,411,000
|
5,410,000
|
Common Stock [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net, shares |
|
|
214,000
|
|
|
Forecast [Member] | Common Stock [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net, shares |
|
6,244,000
|
|
|
|
Principle amount |
|
$ 3.0
|
|
|
|
Conversion price |
|
$ 0.50
|
|
|
|
Forecast [Member] | Prefunded Warrants [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Issuance of shares |
|
1,764,000
|
|
|
|
Warrant exercise price |
|
$ 0.005
|
|
|
|
Principle amount |
|
$ 0.9
|
|
|
|
Conversion price |
|
$ 0.50
|
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net, shares |
38,302,000
|
|
|
|
|
Issuance of shares |
19,902,000
|
|
|
|
|
Issuance of shares |
9,951,000
|
|
|
|
|
Issuance of shares |
28,351,000
|
|
|
|
|
Share price |
$ 1.00
|
|
|
|
|
Common stock, shares issued |
51,400,000
|
|
|
|
|
Common stock, shares outstanding |
51,400,000
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Issuance of common stock |
45,900,000
|
|
|
|
|
Subsequent Event [Member] | Warrant [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net, shares |
1,900,000
|
|
|
|
|
Private Placement [Member] | Subsequent Event [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net, shares |
1,402,000
|
|
|
|
|
Issuance of shares |
115,000
|
|
|
|
|
Gross proceeds |
$ 1.1
|
|
|
|
|
Warrant exercise price |
$ 0.005
|
|
|
|
|
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Eterna Therapeutics (NASDAQ:ERNA)
Historical Stock Chart
Von Dez 2024 bis Jan 2025
Eterna Therapeutics (NASDAQ:ERNA)
Historical Stock Chart
Von Jan 2024 bis Jan 2025