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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 June 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 August 9, 2024, the registrant had outstanding 5,410,588 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)
| |
June 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 2,586 | | |
$ | 7,575 | |
Other receivables | |
| 228 | | |
| 425 | |
Prepaid expenses and other current assets | |
| 769 | | |
| 1,599 | |
Total current assets | |
| 3,583 | | |
| 9,599 | |
Restricted cash | |
| 4,095 | | |
| 4,095 | |
Property and equipment, net | |
| 654 | | |
| 493 | |
Right-of-use assets - operating leases | |
| 35,990 | | |
| 32,781 | |
Goodwill | |
| 2,044 | | |
| 2,044 | |
Other assets | |
| 120 | | |
| 120 | |
Total assets | |
$ | 46,486 | | |
$ | 49,132 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,193 | | |
$ | 1,067 | |
Accrued expenses | |
| 2,389 | | |
| 1,893 | |
Income taxes payable | |
| 7 | | |
| 2 | |
Operating lease liabilities, current | |
| 4,266 | | |
| 2,216 | |
Due to related party, current | |
| 331 | | |
| 1,205 | |
Deferred revenue, current | |
| 189 | | |
| 190 | |
Other current liabilities | |
| 225 | | |
| - | |
Total current liabilities | |
| 9,600 | | |
| 6,573 | |
Convertible notes, net | |
| 8,895 | | |
| 6,773 | |
Warrant liabilities | |
| 50 | | |
| 116 | |
Operating lease liabilities, non-current | |
| 36,044 | | |
| 32,854 | |
Deferred revenue, non-current | |
| 298 | | |
| 392 | |
Contingent consideration liability | |
| 41 | | |
| 107 | |
Other liabilities | |
| 84 | | |
| 84 | |
Total liabilities | |
| 55,012 | | |
| 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 June 30, 2024 and December 31, 2023, $156 liquidation preference | |
| 1 | | |
| 1 | |
Common stock, $0.005 par value, 100,000 shares authorized at June 30, 2024 and December 31, 2023;
5,411 and 5,410 issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 27 | | |
| 27 | |
Additional paid-in capital | |
| 190,611 | | |
| 189,186 | |
Accumulated deficit | |
| (199,165 | ) | |
| (186,981 | ) |
Total stockholders’ (deficit) equity | |
| (8,526 | ) | |
| 2,233 | |
| |
| | | |
| | |
Total liabilities and stockholders’ (deficit) equity | |
$ | 46,486 | | |
$ | 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 June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue | |
$ | 47 | | |
$ | - | | |
$ | 94 | | |
$ | - | |
Cost of revenues | |
| 95 | | |
| - | | |
| 156 | | |
| 50 | |
Gross loss | |
| (48 | ) | |
| - | | |
| (62 | ) | |
| (50 | ) |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 987 | | |
| 1,499 | | |
| 2,445 | | |
| 3,173 | |
General and administrative | |
| 3,896 | | |
| 2,590 | | |
| 8,211 | | |
| 6,182 | |
Acquisition of Exacis in-process research and development | |
| - | | |
| 460 | | |
| - | | |
| 460 | |
Total operating expenses | |
| 4,883 | | |
| 4,549 | | |
| 10,656 | | |
| 9,815 | |
Loss from operations | |
| (4,931 | ) | |
| (4,549 | ) | |
| (10,718 | ) | |
| (9,865 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other (expense) income, net: | |
| | | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| 136 | | |
| 191 | | |
| 66 | | |
| 146 | |
Change in fair value of contingent consideration | |
| 66 | | |
| 118 | | |
| 66 | | |
| 118 | |
Loss on non-controlling investment | |
| - | | |
| (8 | ) | |
| - | | |
| (59 | ) |
Interest (expense) income, net | |
| (797 | ) | |
| 24 | | |
| (1,583 | ) | |
| 25 | |
Other expense, net | |
| - | | |
| (280 | ) | |
| - | | |
| (280 | ) |
Total other (expense) income, net | |
| (595 | ) | |
| 45 | | |
| (1,451 | ) | |
| (50 | ) |
Provision for income taxes | |
| (3 | ) | |
| (4 | ) | |
| (7 | ) | |
| (9 | ) |
Net loss | |
| (5,529 | ) | |
| (4,508 | ) | |
| (12,176 | ) | |
| (9,924 | ) |
Series A preferred stock dividend | |
| (8 | ) | |
| (8 | ) | |
| (8 | ) | |
| (8 | ) |
Net loss attributable to common stockholders | |
$ | (5,537 | ) | |
$ | (4,516 | ) | |
$ | (12,184 | ) | |
$ | (9,932 | ) |
Net loss per common share - basic and diluted | |
$ | (1.02 | ) | |
$ | (0.85 | ) | |
$ | (2.25 | ) | |
$ | (1.90 | ) |
Weighted average shares outstanding - basic and diluted | |
| 5,410 | | |
| 5,303 | | |
| 5,410 | | |
| 5,215 | |
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 six months ended June 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 April 1, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 190,188 | | |
$ | (193,628 | ) | |
$ | (3,412 | ) |
Issuance of common stock from vested restricted stock units | |
| - | | |
| - | | |
| 1 | | |
| - | | |
| - | | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 423 | | |
| - | | |
| 423 | |
Cash dividends to Series A preferred stockholders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8 | ) | |
| (8 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,529 | ) | |
| (5,529 | ) |
Balances at June 30, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,411 | | |
$ | 27 | | |
$ | 190,611 | | |
$ | (199,165 | ) | |
$ | (8,526 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at January 1, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 189,186 | | |
$ | (186,981 | ) | |
$ | 2,233 | |
Issuance of note warrants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 720 | | |
| - | | |
| 720 | |
Issuance of common stock from vested restricted stock units | |
| - | | |
| - | | |
| 1 | | |
| - | | |
| - | | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 705 | | |
| - | | |
| 705 | |
Cash dividends to Series A preferred stockholders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8 | ) | |
| (8 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (12,176 | ) | |
| (12,176 | ) |
Balances at June 30, 2024 | |
| 156 | | |
$ | 1 | | |
| 5,411 | | |
$ | 27 | | |
$ | 190,611 | | |
$ | (199,165 | ) | |
$ | (8,526 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at April 1, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,127 | | |
$ | 26 | | |
$ | 178,066 | | |
$ | (170,713 | ) | |
$ | 7,380 | |
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 | |
Cash dividends to Series A preferred stockholders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8 | ) | |
| (8 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 214 | | |
| - | | |
| 214 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,508 | ) | |
| (4,508 | ) |
Balances at June 30, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 179,067 | | |
$ | (175,229 | ) | |
$ | 3,866 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at January 1, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,127 | | |
$ | 26 | | |
$ | 177,377 | | |
$ | (165,297 | ) | |
$ | 12,107 | |
Balance | |
| 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 | |
Cash dividends to Series A preferred stockholders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8 | ) | |
| (8 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 903 | | |
| - | | |
| 903 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (9,924 | ) | |
| (9,924 | ) |
Balances at June 30, 2023 | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 179,067 | | |
$ | (175,229 | ) | |
$ | 3,866 | |
Balance | |
| 156 | | |
$ | 1 | | |
| 5,410 | | |
$ | 27 | | |
$ | 179,067 | | |
$ | (175,229 | ) | |
$ | 3,866 | |
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 six months ended June 30, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (12,176 | ) | |
$ | (9,924 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 83 | | |
| 42 | |
Stock-based compensation | |
| 705 | | |
| 903 | |
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 | |
Amortization of right-of-use asset | |
| 1,036 | | |
| 83 | |
(Gain) loss on disposal of fixed assets | |
| (2 | ) | |
| 1 | |
Accrued interest expense | |
| 422 | | |
| - | |
Paid-in-kind interest expense | |
| 407 | | |
| - | |
Amortization of debt discount and debt issuance costs | |
| 919 | | |
| - | |
Change in fair value of warrant liabilities | |
| (66 | ) | |
| (146 | ) |
Change in fair value of contingent consideration liability | |
| (66 | ) | |
| (118 | ) |
Loss on non-controlling investment | |
| - | | |
| 59 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Other receivables | |
| 197 | | |
| (33 | ) |
Prepaid expenses and other current assets | |
| 734 | | |
| 214 | |
Other non-current assets | |
| 1 | | |
| (481 | ) |
Accounts payable and accrued expenses | |
| 1,549 | | |
| (454 | ) |
Operating lease liability | |
| 995 | | |
| (215 | ) |
Due to related party | |
| (874 | ) | |
| (875 | ) |
Deferred revenue | |
| (95 | ) | |
| 250 | |
Other liabilities | |
| 225 | | |
| 80 | |
Net cash used in operating activities | |
| (6,006 | ) | |
| (9,921 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchase of property and equipment | |
| (350 | ) | |
| - | |
Proceeds received from the sale of fixed assets | |
| 4 | | |
| - | |
Net cash used in investing activities | |
| (346 | ) | |
| - | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds received from the convertible notes financing | |
| 1,405 | | |
| - | |
Fees paid related to the convertible notes financing | |
| (34 | ) | |
| - | |
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 | |
| 1,363 | | |
| 312 | |
Net decrease in cash and cash equivalents | |
| (4,989 | ) | |
| (9,609 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 11,670 | | |
| 15,541 | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 6,681 | | |
$ | 5,932 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Cash paid during the period for: | |
| | | |
| | |
Interest | |
$ | 6 | | |
$ | 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 | |
$ | 584 | | |
$ | - | |
Adjustment to lease liability and ROU asset due to remeasurement | |
$ | 4,245 | | |
$ | - | |
Property and equipment purchased but not paid | |
$ | 18 | | |
$ | - | |
Initial measurement of ROU assets | |
$ | - | | |
$ | 34,410 | |
Initial measurement of lease liability | |
$ | - | | |
$ | 34,169 | |
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 | |
$ | 2,586 | | |
$ | 1,837 | |
Restricted cash | |
| 4,095 | | |
| 4,095 | |
Total cash, cash equivalents and restricted cash at end of period | |
$ | 6,681 | | |
$ | 5,932 | |
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. is a life science company committed to realizing the potential of mRNA cell engineering to provide patients with
transformational new medicines. Eterna has in-licensed a portfolio of over 100
patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the
NoveSliceTM and UltraSliceTM gene-editing proteins, and the ToRNAdoTM mRNA delivery system, which
Eterna collectively refers to as our “mRNA technology platform.” Eterna refers to aspects of its mRNA technology
platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell reprogramming.” Eterna licenses
its mRNA technology platform from Factor Bioscience Limited (“Factor Limited”) under an exclusive license agreement. 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 six months ended June 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,
including conducting clinical trials and providing general and administrative support for operations. As of June 30, 2024, the Company
had an unrestricted cash balance of approximately $2.6 million and an accumulated deficit of approximately $199.2 million. For the three
and six months ended June 30, 2024, the Company incurred a net loss of $5.5 million and $12.2 million, respectively, and for the six
months ended June 30, 2024, the Company used cash of $6.0 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 see Note 17 for additional information regarding the sublease termination agreement.
In
April 2023, the Company entered into a standby equity purchase agreement (the “SEPA”) 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 SEPA for gross proceeds of $0.3 million. No shares have
been sold under the SEPA during the three and six months ended June 30, 2024.
In
July and December 2023, the Company received $16.5
million in aggregate gross proceeds from the issuance of convertible notes and in January 2024 received an additional $1.4
million in gross proceeds from the issuance of additional convertible notes. See Note 5 for additional information regarding these
financings.
In
connection with preparing the accompanying condensed consolidated financial statements as of and for the three and six months ended June
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 SEPA, public or private equity offerings, debt financings,
out-licensing the Company’s intellectual property, strategic partnerships or other means. Other than the SEPA, 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.
3) ASSET ACQUISITION
On
April 26, 2023, the Company entered into an asset purchase agreement (the “Exacis Purchase Agreement”), with 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 by and 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 an aggregate of 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 the following contingent payments:
| (i) | if,
at any time during the three-year period commencing on the closing date and ending on the
three-year anniversary of the closing date, the Company’s market capitalization equals
or exceeds $100.0 million for at least ten consecutive trading days, then the Company will
issue to Exacis a number of shares of common stock equal to (x) $2.0 million divided by (y)
the quotient of $100.00 million divided by the number of the Company’s then issued
and outstanding shares of common stock; |
| (ii) | if,
at any time during the three-year period commencing on the closing date and ending on the
three-year anniversary of the closing date, the Company’s market capitalization equals
or exceeds $200.0 million for at least ten consecutive trading days, then the Company will
issue to Exacis a number of additional shares of common stock equal to (x) $2.0 million divided
by (y) the quotient of $200.00 million divided by the number of the Company’s then
issued and outstanding shares of common stock (collectively with (i) above, the “Market
Cap Contingent Consideration”); and |
| (iii) | during
the five-year period commencing on the closing date and ending on the five-year anniversary
of the closing date, the Company will pay or deliver to Exacis 20% of all cash or other consideration
(collectively, “License Contingent Consideration”) actually received by the Company
during the five-year period from (i) third-party licensees or sublicensees of the intellectual
property rights acquired by the Company from Exacis pursuant to the Exacis Purchase Agreement,
or (ii) subject to certain exceptions, the sale of such intellectual property rights; provided,
that the License Contingent Consideration shall not in any event exceed $45.0 million. |
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 six months ended June 30, 2023.
4) 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 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 obtains the sublicense, the Company would be entitled to receive additional license fees, including milestone
payments and royalties.
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 will make such purchases. Therefore, 100% of the
Option Fee was allocated to the Option Right. The Option Fee will remain in deferred revenue until such time that Lineage enters into
the sublicense or when the Option Right expires.
The
Option Right and the cell line customization activities are accounted for as separate contracts, and the Company has determined that
the amended terms discussed above represent 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
will make payments to the Company for the cell line customization activities over the development period. The Company will only earn
the remaining full amount of the cell line customization fee if it makes certain progress towards delivery of the customized cell
line. The Company has determined that $0.4
million of consideration received could be recognized without the probability of being reversed, and it has placed a constraint on
the remaining contractual customization fee. The $0.4
million is being recognized equally over the development period, which is expected to be approximately 20 to 25 months, as the level
of effort to perform the services is happening at the same rate over time. If the development period is expected to be longer or
shorter than originally planned, the Company will recognize a cumulative catch-up adjustment in the period that such determination
is made. For the three and six months ended June 30, 2024, the Company recognized less than $0.1
million and $0.1
million of revenue, respectively, for the customization activities. The Company did not
recognize any revenue for either of the three or six months ended June 30, 2023.
The
granting of the license that the Company may provide to Lineage if Lineage exercises the Option Right is not considered a performance
obligation at this time, as it is an optional request that the customer may make in the future and will be accounted for as a separate
contract when the customer exercises the Option Right.
The
Company recognizes
direct labor and supplies used in the customization activities as incurred and are recorded as a cost of revenue. As provided
for in the A&R Factor License Agreement discussed in Note 9, the Company is obligated to pay Factor Limited 20% of any amounts the
Company receives from a customer that is related to the licensed technology under the A&R Factor License Agreement, which is also
recorded as a cost of revenue. For the six months ended June 30, 2023, the Company recognized less than $0.1 million in license fees,
which is recorded in cost of revenues, due to Factor Limited as a result of receiving the $0.3 million Option Fee payment from Lineage.
There was no such license fee incurred during the three months ended June 30, 2023 or during the three or six months ended June 30,
2024.
5) CONVERTIBLE NOTES FINANCINGS
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 annum, and the December 2023 convertible notes bear interest at 12% per annum, 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 time-to-time in whole or in part into shares of the Company’s
common stock at an initial conversion rate 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 June 30, 2024, none of the convertible notes were converted into shares of common stock.
The
convertible notes do not contain any ratchet or other financial antidilution provisions. The convertible notes contain conversion limitations
such that no conversion may be made if the aggregate number of shares of common stock beneficially owned by the holder thereof would
exceed 4.99%, 9.99% or 19.99% immediately after conversion thereof, subject to certain increases not in excess of either 9.99% or 19.99%
at the option of such holder.
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 thereof 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 June 30, 2024, there were no events of default that occurred under the convertible
notes.
The
Company determined that there were no embedded derivatives within the convertible notes that required bifurcation from the host agreement.
In connection with the December 2023 convertible notes that were issued on January 11, 2024, the Company allocated the gross proceeds
received and the fees incurred over the applicable convertible notes and warrants based on their relative fair values as follows (in
thousands):
SCHEDULE OF BASED ON RELATIVE FAIR VALUE ALLOCATION OF PROCEEDS AND COSTS
| |
Relative | | |
Allocation | | |
Allocation of Proceeds and Costs | | |
Allocation of Proceeds, | |
| |
Fair Value | | |
Percentage | | |
Proceeds | | |
Costs | | |
Net | |
Convertible notes | |
$ | 1,750 | | |
| 46.24 | % | |
$ | 650 | | |
$ | (31 | ) | |
$ | 619 | |
Note warrants | |
| 2,035 | | |
| 53.76 | % | |
| 755 | | |
| (35 | ) | |
| 720 | |
| |
$ | 3,785 | | |
| 100.00 | % | |
$ | 1,405 | | |
$ | (66 | ) | |
$ | 1,339 | |
The
Company estimated the fair values of the convertible notes as of January 11, 2024 based off a valuation performed by a third-party specialist
as of December 15, 2023 using a binomial tree model and the following assumptions:
SCHEDULE OF FAIR VALUE ASSUMPTIONS
| |
Stock Price | | |
Credit Spread | | |
Volatility | | |
Risk-Free Rate | |
Convertible notes | |
$ | 1.75 | | |
| 2,000 | | |
| 109 | % | |
| 3.90 | % |
The
fair value of the note warrants, all of which qualified for equity classification, was determined using the Black-Scholes pricing model
as of January 11, 2024 using the following assumptions:
| |
Stock Price | | |
Exercise Price | | |
Expected Life | |
Volatility | | |
Dividend | | |
Risk-Free Rate | |
Warrants | |
$ | 1.75 | | |
$ | 1.43 | | |
5 years | |
| 102 | % | |
| 0.00 | % | |
| 3.90 | % |
The
amount of proceeds allocated to the note warrants resulted in a corresponding reduction in the carrying value of the respective convertible
notes as a debt discount, which is amortized with the debt issuance costs as a component of interest expense based on the effective interest
rate method over the contractual terms of the convertible notes.
The
following table shows the activity that occurred during the six months ended June 30, 2024 for the convertible notes on the accompanying
condensed consolidated balance sheet:
SCHEDULE OF ACTIVITY OF CONVERTIBLE NOTES
| |
Gross convertible notes | | |
Debt discount and debt issuance costs | | |
Convertible notes, net | |
| |
| | |
| | |
| |
Beginning balance as of January 1, 2024 | |
$ | 16,616 | | |
$ | (9,843 | ) | |
$ | 6,773 | |
December 2023 notes issued in January 2024 | |
| 1,405 | | |
| (786 | ) | |
| 619 | |
Paid-in-kind interest added to principal | |
| 584 | | |
| - | | |
| 584 | |
Amortization of debt discount and debt issuance costs | |
| - | | |
| 919 | | |
| 919 | |
Ending balance as of June 30, 2024 | |
$ | 18,605 | | |
$ | (9,710 | ) | |
$ | 8,895 | |
To
date, the Company has elected to pay in-kind the accrued interest payable on the convertible notes and has added the accrued and
unpaid interest to the principal amount of the applicable convertible note. For the three months ended June 30, 2024, the Company
has recognized approximately $0.9
million in interest expense for the convertible notes, which includes $0.5
million for the amortization of the debt discount and debt issuance costs and $0.4
million for accrued and unpaid interest on the convertible notes recorded in accrued expenses in the accompanying condensed
consolidated balance sheet. For the six months ended June 30, 2024, the Company has recognized approximately $1.7
million in interest expense, which includes $0.9
million for the amortization of the debt discount and debt issuance costs, $0.4
million recorded for accrued and unpaid interest on the convertible notes recorded in accrued expenses in the accompanying condensed
consolidated balance sheet and $0.4
million of accrued interest that was paid in-kind and added to the principal of the convertible notes.
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 and cash equivalents, 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. Both of these liabilities
are remeasured at each reporting period, with changes in their fair values recognized in earnings.
The
Company uses a Black-Scholes option pricing model to estimate the fair value of its 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 remeasures the fair value of the warrant liabilities 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 June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE
Description | |
Level | | |
June 30, 2024 | | |
December 31, 2023 | |
Liabilities: | |
| | | |
| | | |
| | |
Warrant liabilities - Q1-22 warrants | |
| 3 | | |
$ | 50 | | |
$ | 116 | |
Market Cap Contingent Consideration | |
| 3 | | |
$ | 41 | | |
$ | 107 | |
Liabilities, fair value disclosure | |
| 3 | | |
$ | 41 | | |
$ | 107 | |
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 June 30, 2024 (in thousands):
SCHEDULE OF CHANGES IN WARRANT LIABILITIES
| |
Warrant Liabilities | | |
Contingent Consideration | |
| |
| | |
| |
Fair value at January 1, 2024 | |
$ | 116 | | |
$ | 107 | |
Change in fair value | |
| (66 | ) | |
| (66 | ) |
Fair value at June 30, 2024 | |
$ | 50 | | |
$ | 41 | |
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 June 30, 2024 and December 31, 2023
(in thousands).
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES
| |
| | |
June 30, 2024 | | |
December 31, 2023 | |
| |
Level | | |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
Convertible notes | |
| 3 | | |
$ | 18,605 | | |
$ | 22,470 | | |
$ | 16,616 | | |
$ | 17,594 | |
The
carrying value in the table above is shown before the allocation of the proceeds to the note warrants. The Company assesses the fair
value of the convertible notes as of June 30, 2024 using a Monte Carlo simulation model and as of December 31, 2023 using a binomial
model, both of which are considered a Level 3 measurement.
7) 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 June 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.
8) LEASES
The
Company currently has operating leases for office and laboratory space 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 provides 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.
The
Sublessor provided the Company with a tenant improvement allowance (“TIA”) of $per rentable square foot, or $8.6
million. As of June 30, 2024, the Company received
the entire $8.6
million TIA. The Company incurred out-of-pocket tenant improvements costs of approximately $1.6 million, which were in excess
of the $8.6 million TIA.
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. See Note 17 for more information on the sublease termination agreement.
For
the three and six months ended June 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 June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease expense | |
$ | 1,633 | | |
$ | 67 | | |
$ | 3,269 | | |
$ | 135 | |
Sublease income | |
| (21 | ) | |
| (21 | ) | |
| (42 | ) | |
| (42 | ) |
Variable lease expense | |
| 332 | | |
| 7 | | |
| 663 | | |
| 12 | |
Total lease expense | |
$ | 1,944 | | |
$ | 53 | | |
$ | 3,890 | | |
$ | 105 | |
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 June 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 | |
Amortization of operating lease ROU assets | |
| (1,036 | ) |
Operating lease ROU assets at June 30, 2024 | |
$ | 35,990 | |
| |
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 | |
| 1,787 | |
Principal payments on operating lease liabilities | |
| (792 | ) |
Operating lease liabilities at June 30, 2024 | |
| 40,310 | |
Less non-current portion | |
| 36,044 | |
Current portion at June 30, 2024 | |
$ | 4,266 | |
As
of June 30, 2024, the Company’s operating leases had a weighted-average remaining life of 9.3 years with a weighted-average discount
rate of 11.07%. The maturities of the operating lease liabilities are as follows (in thousands):
MATURITIES
OF OPERATING LEASE LIABILITIES
| |
As of June 30, 2024 | |
2024 | |
$ | 5,305 | |
2025 | |
| 6,075 | |
2026 | |
| 6,238 | |
2027 | |
| 6,308 | |
2028 | |
| 6,406 | |
Thereafter | |
| 33,879 | |
Total payments | |
| 64,211 | |
Less imputed interest | |
| (23,901 | ) |
Total operating lease liabilities | |
$ | 40,310 | |
9) ACCRUED EXPENSES
Accrued
expenses at June 30, 2024 and December 31, 2023 consisted of the following (in thousands):
SCHEDULE
OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
Somerville facility | |
$ | 547 | | |
$ | 218 | |
Legal fees | |
| 545 | | |
| 643 | |
Convertible notes interest | |
| 422 | | |
| 176 | |
Professional fees | |
| 229 | | |
| 239 | |
Accrued compensation | |
| 134 | | |
| 109 | |
Other | |
| 512 | | |
| 508 | |
Total accrued expenses | |
$ | 2,389 | | |
$ | 1,893 | |
10) RELATED PARTY TRANSACTIONS
Agreements
with Factor Bioscience Inc. and Affiliates
As
of June 30, 2024, the Company had 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 will be 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 by and among Eterna LLC, Novellus Limited and Factor Limited (the “Original Factor License Agreement”). Under the terms
of 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 June 30, 2024, there was approximately $0.3 million of the unamortized License
Fee Obligation remaining, which is recorded on the accompanying condensed consolidated balance sheet in the “due to related party,
current” line item.
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 terms of 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 term of the A&R Factor License Agreement expires on
November 22, 2027, but will be automatically extended for an additional five years (such period, the “Renewal Term”) if the
Company pays at least $6.0 million to Factor Limited from fees from sublicenses to the Factor Patents (“Sublicense Fees”),
other cash on hand or a combination of both sources of funds. The Company will pay to Factor Limited 20% of any Sublicense Fee received
by the Company during the term of the A&R Factor License Agreement. Beginning in September 2024, the Company will also begin paying
Factor Limited a monthly maintenance fee of approximately $0.4 million until the expiration of the A&R Factor License Agreement,
including any Renewal Term. The Company may terminate the A&R Factor License Agreement upon 120 days’ written notice to Factor
Limited, and both parties have additional customary termination rights. Under the A&R Factor License Agreement, the Company is obligated
to pay the expenses incurred by Factor Limited in preparing, filing, prosecuting and maintaining the Factor Patents and the Company agreed
to bear all costs and expenses associated with enforcing and defending the Factor Patents in any action or proceeding arising from pursuit
of sublicensing opportunities under the license granted under the A&R Factor License Agreement.
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 and December 2023 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 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 4 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.
A status conference has been set for September 12, 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.
Licensing
Agreements
On
November 14, 2023, the Company entered into the A&R Factor License Agreement with Factor Limited. See Note 9 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 three and six months ended June 30, 2024 and 2023, the Company granted stock 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Stock options granted | |
| 501 | | |
| 25 | | |
| 2,375 | | |
| 237 | |
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 stock 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 now 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 three and six months ended June 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 three and six months ended June 30, 2024 and 2023:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS USED FOR STOCK OPTIONS GRANTED
ixbrl | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted average risk-free rate | |
| 4.32 | % | |
| 3.54 | % | |
| 4.45 | % | |
| 3.82 | % |
Weighted average volatility | |
| 91.77 | % | |
| 96.09 | % | |
| 97.91 | % | |
| 95.15 | % |
Dividend yield | |
| 0.00 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected term | |
| 5.68 years | | |
| 6.08 years | | |
| 5.85 years | | |
| 5.44 years | |
The
per-share weighted average grant-date fair value of stock options granted during the three and six months ended June 30, 2024 and
2023 were as follows:
SCHEDULE
OF WEIGHTED AVERAGE GRANT-DATE FAIR VALUE OF STOCK OPTIONS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted average grant date fair value | |
$ | 1.42 | | |
$ | 1.64 | | |
$ | 1.44 | | |
$ | 2.99 | |
Vesting
of all stock options is subject to continuous service with the Company through the applicable vesting date. As of June 30, 2024,
there were approximately 2,536,000 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 six months ended June 30, 2024 and 2023, less than 1,000 RSUs vested. As of June 30,
2024, there were less than 1,000 RSUs outstanding.
The
Company did not grant RSUs during either of the three or six months ended June 30, 2024 and 2023.
Stock-Based
Compensation Expense
For
the three and six months ended June 30, 2024 and 2023, the Company recognized stock-based compensation expense as follows (in thousands):
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 15 | | |
$ | 56 | | |
$ | 61 | | |
$ | 120 | |
General and administrative | |
| 408 | | |
| 158 | | |
| 644 | | |
| 783 | |
Total | |
$ | 423 | | |
$ | 214 | | |
$ | 705 | | |
$ | 903 | |
13) 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 warrants outstanding
from a private placement completed in the fourth quarter of 2022 (the “Q4-22 warrants”).
As
of June 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 |
Q4-22 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 June 30, 2024, the weighted average remaining contractual life of the warrants outstanding was 4.21 years and the weighted average
exercise price was $2.05.
14) 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 six months
ended June 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 six months ended June 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 20,386 | | |
| 4,713 | |
Convertible Notes converted into common stock | |
| 8,135 | | |
| - | |
Stock options | |
| 2,536 | | |
| 522 | |
Preferred stock converted into common stock | |
| 19 | | |
| 7 | |
RSUs | |
| - | | |
| 1 | |
Total potential common shares excluded from computation | |
| 31,076 | | |
| 5,243 | |
15) STANDBY EQUITY PURCHASE AGREEMENT
On
April 5, 2023, the Company entered into the SEPA 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, 2025, which was the date on which
each of the conditions to the 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 six months ended June 30, 2023.
In
April 2023, the Company filed a registration statement on Form S-1 (File No. 333-271279) 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 “SEPA S-1”).
During
the three and six months ended June 30, 2023, the Company issued and sold approximately 214,000
shares of common stock under the SEPA, including the approximately 74,000
commitment shares, for gross proceeds of $0.3
million. No
shares have been sold under the SEPA during the three or six months ended June 30, 2024. As of June 30, 2024, there were
approximately 2,716,000
shares remaining to be sold under the SEPA that are registered for resale by Lincoln Park under the SEPA 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.
17) SUBSEQUENT EVENT
On August 5, 2024, the sublessor
of the Company’s sublease for the property located in Somerville, Massachusetts drew down on the letter of credit related to the
sublease 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 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, the Company agreed to surrender and vacate the premises, all of 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 both parties will be released of their obligations under the sublease. As a result of the sublease termination, the Company expects to save approximately $58.5 million in base rental payments
plus parking, operating expenses, taxes and utilities that it would have paid over the remaining lease term.
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 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 life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new
medicines. We have in-licensed a portfolio of over 100 patents covering key mRNA cell engineering technologies, including technologies
for mRNA cell reprogramming, mRNA gene editing, the NoveSliceTM and UltraSliceTM gene-editing proteins, and the
ToRNAdoTM mRNA delivery system, which we collectively refer to as our “mRNA technology platform.” We refer to
aspects of our mRNA technology platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell reprogramming.”
We license our mRNA technology platform from Factor Bioscience Limited (“Factor Limited”) under an exclusive license agreement.
We
believe that our proprietary technology platform can be used to develop novel pharmaceutical products to treat a broad range of diseases
and address unmet medical needs.
In
the short term, we are planning to derive revenue by leveraging our core intellectual property (“IP”) portfolio by licensing
our IP to third parties in out-licensing or co-development arrangements. In addition, we are also planning to enhance our developmental
activities through preclinical studies in selected indications.
In
the mid-term, we are planning to transform our preclinical stage company into a clinical-stage company through investigational new drug
application (“IND”)-enabling studies, IND approval, and initiation of our first-in-human study. After achieving the initial
milestones, we’ll seek to diversify our pipeline of product candidates and strengthen the mRNA technology platform with the goal
of generating IND applications each year.
In
the long term, we aspire to become a therapeutics company with multiple approved gene and cellular therapy products across multiple indications
in oncology, autoimmune diseases, and rare diseases.
We
refer to aspects of our mRNA technology platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell
reprogramming.”
mRNA
Delivery
Nucleic
acids, such as mRNA, can be used to induce cells to express desired proteins, including proteins that are capable of re-writing genetic
and epigenetic cellular programs. However, the plasma membrane surrounding cells normally protects cells from exogenous nucleic acids,
preventing efficient uptake and protein translation. Delivery systems can be used to enhance the uptake of nucleic acids by cells. Conventional
delivery systems, such as lipid nanoparticle (“LNP”)-based delivery, often suffer from endosomal entrapment and toxicity,
which can limit their therapeutic use. Our mRNA delivery technology is designed to use a novel chemical substance that is designed to
deliver nucleic acids, including mRNA, to cells both ex vivo and in vivo. Our nucleic-acid delivery technology is also
designed for ex vivo delivery of mRNA encoding gene-editing proteins and reprogramming factors, including to primary cells, insertion
of exogenous sequences into genomic safe-harbor loci, and in vivo delivery of mRNA to the brain, eye, skin, and lung, which may
be useful for the development of mRNA-based therapeutic.
mRNA
Gene Editing
Our
mRNA gene-editing technology is designed to delete, insert, and repair DNA sequences in living cells, which may be useful for correcting
disease-causing mutations, making cells resistant to infection and degenerative disease, modulating the expression of immunoregulatory
proteins to enable the generation of durable allogeneic cell therapies, and engineering immune cells to more effectively fight cancer.
Conventional
gene-editing technologies typically employ plasmids or viruses to express gene-editing proteins, which can result in low-efficiency editing
and unwanted mutagenesis when an exogenous nucleic acid fragment is inserted at random locations in the genome. Our mRNA gene-editing
technology instead is designed to employ mRNA to express gene-editing proteins, which can potentially enable gene editing without unwanted
insertional mutagenesis, because, unlike conventional gene-editing technologies that employ viruses or DNA-based vectors, mRNA does not
typically cause unwanted insertional mutagenesis. We believe the efficiency of our mRNA gene-editing technology has the potential to
support development of product candidates that could create new therapeutic approaches. For example, we anticipate that our mRNA gene-editing
technology can be used to generate allogeneic chimeric antigen receptor T-cell (“CAR-T”) therapies for the treatment of cancer.
In such allogeneic CAR-T therapies, mRNA encoding gene-editing proteins would be used to inactivate the endogenous T-cell receptor to
prevent therapeutic T-cells from causing graft-versus-host disease (“GvHD”). GvHD occurs when transplanted cells view the
patient’s (i.e., the host’s) cells as a threat and attack the host’s cells. We expect that this same mechanism of action
can generate allogeneic stem cell-derived therapies in which mRNA encoding gene-editing proteins could be used to inactivate one or more
components of the human leukocyte antigen (“HLA”) complex to render the cells immuno-nonreactive or “stealth,”
which may be useful for the development of allogeneic cell-based therapies.
mRNA
Cell Reprogramming
Our
mRNA cell-reprogramming technology is capable of generating clonal lines of pluripotent stem cells that can be expanded and differentiated
into many desired cell types that may be useful for the development of regenerative cell therapies.
Conventional
cell-reprogramming technologies (e.g., using Sendai virus or episomal vectors) can result in low efficiency reprogramming, can select
for cells with abnormal growth characteristics, and can leave traces of the vector in reprogrammed cells. Our mRNA cell-reprogramming
technology instead is designed to employ mRNA to express reprogramming factors, which can enable cell reprogramming without leaving traces
of the vector in reprogrammed cells, because, unlike conventional cell-reprogramming technologies that employ viruses or DNA-based vectors,
mRNA does not typically leave traces of the vector in reprogrammed cells.
Recent
Developments
Sublessor Draw on Letter
of Credit and Termination of Sublease
In October
2022, we entered into a sublease for office and laboratory space in Somerville, Massachusetts. See Note 8 to the accompanying condensed
consolidated financial statements for additional information regarding the sublease.
As previously reported, on May
3, 2024, we received a notice from the sublessor regarding past due rent of approximately $2.3 million that we did not pay for the months
of February, March, April and May 2024. We also did not pay the rent for June, July or August 2024 and, as of August 1, 2024, we owed
approximately $4.0 million in the aggregate in past due rent.
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, 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 expect to save approximately $58.5
million in base rental payments plus parking, operating expenses, taxes and utilities that we would have paid over the remaining lease
term.
We do not expect
that the termination of the sublease will impact our current business needs.
Ex
Parte Re-examination Certificates Received
As of
November 16, 2022, three of our in-licensed patents were subject to re-examination by the United States Patent and Trademark Office (“USPTO”),
under Re-examination Request Nos. US 90/019,127, US 90/019,128, and US 90/019,129. We have now received Ex Parte Reexamination Certificates
for each of these requests, as of June 5, 2024, June 28, 2024, and June 21, 2024, respectively. In each case, the challenged patents
survived this challenge to their validity. The challenged claims were minimally amended, and none were invalidated. The claims have now
been twice examined by the USPTO and twice allowed.
Non-Compliance
with Nasdaq’s Minimum Stockholders’ Equity Rule
As previously reported, on March 19, 2024, we received a notice from The Nasdaq Stock Market LLC stating that we
are not in compliance with 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. Our stockholders’ equity was $2.2 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. See the risk
factor titled “Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock,”
in Item 1A. Risk Factors of Part II of this report.
Basis
of Presentation
Revenue
Our
near-term focus is on deploying our mRNA technology platform through strategic partnerships. We
are not currently developing any product candidates. Our future revenue, if any, is primarily expected to come from out-licensing our
mRNA technology platform and/or aspects thereof.
In
February 2023, we entered into an exclusive option and license agreement with a third party, under which we granted such third party
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, that third party requested that we begin developing certain
induced pluripotent stem cell lines in exchange for a cell line customization fee. The third party paid us $0.4 million towards the customization
fee, which we are recognizing ratably over the customization period, which is expected to be approximately 20 to 25 months. We will only
earn the remaining amount of the customization fee if we make certain progress towards delivery of the customized cell line. We estimate
the amount of consideration we expect to recognize as revenue that is not probable of having a significant reversal of such recognized
revenue, and we place a constraint on the remaining contractual consideration. As it becomes evident that the constrained amounts are
no longer at risk of a significant reversal of revenue, we will remove the constraint from the related revenue and recognize a cumulative
catch-up adjustment to revenue in the period in which the constraint was removed. For additional information, see Note 3 to the accompanying
condensed consolidated financial statements.
Cost
of Revenues
We
recognize direct labor and supplies associated with generating our revenue as cost of revenues. As provided for in the amended and restated
exclusive license agreement we entered into with Factor Limited (the “A&R Factor License Agreement”) discussed in Note
9 to the accompanying condensed consolidated financial statements, we are obligated to pay Factor Limited 20% of any amounts we receive
from a customer that is 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 Six Months Ended June 30, 2024 and 2023
| |
Three months ended
June 30, | | |
| | |
Six months ended
June 30, | | |
| |
| |
2024 | | |
2023 | | |
Change | | |
2024 | | |
2023 | | |
Change | |
Revenue | |
$ | 47 | | |
$ | - | | |
$ | 47 | | |
$ | 94 | | |
$ | - | | |
$ | 94 | |
Cost of revenues | |
| 95 | | |
| - | | |
| 95 | | |
| 156 | | |
| 50 | | |
| 106 | |
Gross loss | |
| (48 | ) | |
| - | | |
| (48 | ) | |
| (62 | ) | |
| (50 | ) | |
| (12 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 987 | | |
| 1,499 | | |
| (512 | ) | |
| 2,445 | | |
| 3,173 | | |
| (728 | ) |
General and administrative | |
| 3,896 | | |
| 2,590 | | |
| 1,306 | | |
| 8,211 | | |
| 6,182 | | |
| 2,029 | |
Acquisition of Exacis in-process research and development | |
| - | | |
| 460 | | |
| (460 | ) | |
| - | | |
| 460 | | |
| (460 | ) |
Total operating expenses | |
| 4,883 | | |
| 4,549 | | |
| 334 | | |
| 10,656 | | |
| 9,815 | | |
| 841 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (4,931 | ) | |
| (4,549 | ) | |
| (382 | ) | |
| (10,718 | ) | |
| (9,865 | ) | |
| (853 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Other (expense) income, net: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| 136 | | |
| 191 | | |
| (55 | ) | |
| 66 | | |
| 146 | | |
| (80 | ) |
Change in fair value of contingent consideration | |
| 66 | | |
| 118 | | |
| (52 | ) | |
| 66 | | |
| 118 | | |
| (52 | ) |
Loss on non-controlling investment | |
| - | | |
| (8 | ) | |
| 8 | | |
| - | | |
| (59 | ) | |
| 59 | |
Interest (expense) income, net | |
| (797 | ) | |
| 24 | | |
| (821 | ) | |
| (1,583 | ) | |
| 25 | | |
| (1,608 | ) |
Other expense, net | |
| - | | |
| (280 | ) | |
| 280 | | |
| - | | |
| (280 | ) | |
| 280 | |
Total other (expense) income, net | |
| (595 | ) | |
| 45 | | |
| (640 | ) | |
| (1,451 | ) | |
| (50 | ) | |
| (1,401 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Loss before income taxes | |
| (5,526 | ) | |
| (4,504 | ) | |
| (1,022 | ) | |
| (12,169 | ) | |
| (9,915 | ) | |
| (2,254 | ) |
Provision for income taxes | |
| (3 | ) | |
| (4 | ) | |
| 1 | | |
| (7 | ) | |
| (9 | ) | |
| 2 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,529 | ) | |
$ | (4,508 | ) | |
$ | (1,021 | ) | |
$ | (12,176 | ) | |
$ | (9,924 | ) | |
$ | (2,252 | ) |
Revenue
During
the three and six months ended June 30, 2024, we recognized revenue related to the cell line customization activities that we are performing
for a third party. We did not perform any such activities, or otherwise recognize any revenue, during the three or six months ended
June 30, 2023.
Cost
of Revenue
During
the three and six months ended June 30, 2024, our cost of revenues included direct labor and materials to perform the customization cell
line activities for a third party. During the six months ended June 30, 2023, we received a $0.3 upfront payment pursuant to a customer
contract with this third party. Although the $0.3 million was recorded as deferred revenue as of June 30, 2023, the obligation to pay
Factor Limited the 20% license fee was incurred upon receipt of the payment from the third party, and was therefore recognized as a cost
of revenue during the six months ended June 30, 2023. There were no such costs recognized during the three months ended June 30, 2023.
As of June 30, 2024, the $0.3 upfront payment continues to be recognized in long-term deferred revenue in the accompanying condensed
consolidated balance sheet.
Research
and Development Expenses
| |
Three months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | | |
| | | |
| | |
Payroll-related | |
$ | 61 | | |
$ | 167 | | |
$ | (106 | ) |
Stock-based compensation | |
| 15 | | |
| 56 | | |
| (41 | ) |
MSA fees | |
| 813 | | |
| 813 | | |
| - | |
Other expenses, net | |
| 98 | | |
| 463 | | |
| (365 | ) |
Total research and development expenses | |
$ | 987 | | |
$ | 1,499 | | |
$ | (512 | ) |
| |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | | |
| | | |
| | |
Professional fees | |
$ | 88 | | |
$ | 449 | | |
$ | (361 | ) |
Stock-based compensation | |
| 61 | | |
| 120 | | |
| (59 | ) |
MSA expense | |
| 1,625 | | |
| 1,625 | | |
| - | |
Payroll-related | |
| 386 | | |
| 369 | | |
| 17 | |
Other expenses, net | |
| 285 | | |
| 610 | | |
| (325 | ) |
Total research and development expenses | |
$ | 2,445 | | |
$ | 3,173 | | |
$ | (728 | ) |
Total
research and development expenses decreased by approximately $0.5 million for the three months ended June 30, 2024 when compared to the
three months ended June 30, 2023 primarily due to a decrease in payroll-related expenses from a reduction in headcount as well as a reduction
in other expenses related to closing down a clinical trial we ended in 2022.
Total
research and development expenses decreased $0.7 million for the six months ended June 30, 2024 when compared to the six months ended
June 30, 2023 primarily related to a decrease in expenses related to closing down the clinical trial from 2022 as well as a reduction
in ongoing research expenses.
General
and Administrative Expenses
| |
Three months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | | |
| | | |
| | |
Occupancy expense | |
$ | 1,899 | | |
$ | 19 | | |
$ | 1,880 | |
Stock-based compensation | |
| 408 | | |
| 158 | | |
| 250 | |
Insurance | |
| 96 | | |
| 194 | | |
| (98 | ) |
Payroll-related | |
| 335 | | |
| 700 | | |
| (365 | ) |
Professional fees | |
| 999 | | |
| 1,392 | | |
| (393 | ) |
Other expenses, net | |
| 159 | | |
| 127 | | |
| 32 | |
Total general and administrative expenses | |
$ | 3,896 | | |
$ | 2,590 | | |
$ | 1,306 | |
| |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
Change | |
(in thousands) | |
| | | |
| | | |
| | |
Occupancy expense | |
$ | 3,800 | | |
$ | 43 | | |
$ | 3,757 | |
Stock-based compensation | |
| 644 | | |
| 783 | | |
| (139 | ) |
Payroll-related | |
| 867 | | |
| 1,057 | | |
| (190 | ) |
Insurance | |
| 312 | | |
| 726 | | |
| (414 | ) |
Professional fees | |
| 2,283 | | |
| 3,328 | | |
| (1,045 | ) |
Other expenses, net | |
| 305 | | |
| 245 | | |
| 60 | |
Total general and administrative expenses | |
$ | 8,211 | | |
$ | 6,182 | | |
$ | 2,029 | |
Our
general and administrative expenses increased by approximately $1.3 and $2.0 million for the three and six months ended June 30, 2024,
respectively, when compared to the three and six months ended June 30, 2023 primarily due to increased occupancy expense related to the
Somerville sublease that we began to incur in July 2023. 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 three and six months ended June 20, 2024 compared to the three and six months ended June 30, 2023.
Acquisition
of Exacis In-Process Research and Development
In
April 2023, we acquired from Exacis Biotherapeutics Inc. (“Exacis”) substantially all of its intellectual property
assets, including all of its right, title and interest in and to an exclusive license agreement by and between Exacis and Factor
Limited (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 six month ended June 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 six
months ended June 30, 2024.
Change
in Fair Value of Warrant Liabilities
We
recognized credits of approximately $0.1 million in each of the three and six months ended June 30, 2024 for the change in the fair value
of warrant liabilities due to a decrease in the market price of our common stock as of June 30, 2024. For the three and six months ended
June 30, 2023, we recognized credits of $0.2 million and $0.1 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 June 30, 2023.
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 three and six months ended June 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 June 30, 2023, we remeasured the contingent liability and recognized a credit of $0.1 million
for both the three and six months ended June 30, 2023 due to the decrease in the fair value of the contingent consideration
liability. As of June 30, 2024, we remeasured the contingent liability and recognized a credit of $0.1 million for both the three
and six months ended June 30, 2024 due to the decrease in the fair value of the contingent consideration liability.
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 six months ended June 30, 2024. We recognized a de minimus loss related to NoveCite for the three months ended
June 30, 2023 and a loss of approximately $0.1 million for the six months ended June 30, 2023.
Interest
(Expense) Income, net
We
recognized an increase in interest expense for the three and six months ended June 30, 2024 of approximately $0.8 million and $1.6
million, respectively, primarily due to approximately $0.4 million and $0.8 million of interest for the three and six months ended
June 30, 2024, respectively, related to the convertible notes as well as the amortization of the debt discount and debt issuance
costs associated with the convertible note financings of approximately $0.5 million and $0.9 million for the three and six months
ended June 30, 2024, respectively. This increase in interest expense was partially offset by an increase in interest income of $0.1
million in each of the three and six months ended June 30, 2024 from our cash deposited into interest-bearing accounts. There were no convertible notes (or similar debt instruments) outstanding during the three or six
months ended June 30, 2023.
Other
Expense, net
During
the three and six months ended June 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
(“SEPA”) we entered into in April 2023 as well as other associated fees. We did not recognize any such expense during
the three or six months ended June 30, 2024.
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
At
June 30, 2024, we had cash and cash equivalents of approximately $6.7 million, of which approximately $4.1 million was restricted cash and an accumulated deficit of approximately $199.2 million. We
have to date incurred operating losses, and we expect these losses to continue in the future. For the three and six months ended June
30, 2024, we incurred a net loss of $5.5 million and $12.2 million, respectively. For the six months ended June 30, 2024, we used $6.0
million in operating activities.
Currently,
our sole source of liquidity is through sales of our common stock under the SEPA, 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 SEPA, including a condition that we may not direct Lincoln Park to purchase any shares of common stock
under the SEPA 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 SEPA 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 the approximately 74,000 commitment
shares, and have received approximately $0.3 million in gross proceeds from such sales. We sold no shares under the SEPA during the
six months ended June 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 if we fail to obtain the necessary financing, we may not be able to
pursue our business strategy.”
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 six months ended June 30, | | |
| |
(in thousands) | |
2024 | | |
2023 | | |
Change | |
Cash (used in) provided by: | |
| | | |
| | | |
| | |
Operating activities | |
$ | (6,006 | ) | |
$ | (9,921 | ) | |
$ | 3,915 | |
Investing activities | |
| (346 | ) | |
| - | | |
| (346 | ) |
Financing activities | |
| 1,363 | | |
| 312 | | |
| 1,051 | |
Net decrease in cash and cash equivalents | |
$ | (4,989 | ) | |
$ | (9,609 | ) | |
$ | 4,620 | |
Net
Cash Used in Operating Activities
There
was a decrease of approximately $3.9 million in cash used in operating activities for the six months ended June 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 $4.2 million,
primarily related to increased accounts payable, accrued expenses and operating lease liabilities, partially offset by a $0.3
million increase in net loss, after giving effect to adjustments made for non-cash transactions, for the six months ended June 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 six months ended June 30, 2024. There were
no investing activities during the six months ended June 30, 2023.
Net
Cash Provided by Financing Activities
Net
cash provided by financing activities for the six months ended June 30, 2024 includes approximately $1.4 million of proceeds received
from the second closing of the December 2023 convertible notes financing that occurred in January 2024 . Net cash provided by financing
activities for the six months ended June 30, 2023 includes approximately $0.3 million of proceeds received from selling approximately
214,000 shares to Lincoln Park under the SEPA. The Company did not sell any shares under the SEPA during the six months ended June 30,
2024.
Material Cash Requirements
Convertible
Notes
As
of the filing date of this report, the aggregate amount outstanding under our convertible notes, including accrued interest that has
been paid in-kind, is $19.0 million, of which $9.2 million and $9.8 million relates to the July 2023 convertible notes and the
December 2023 convertible notes, respectively. Unless earlier called for redemption by the holders thereof, the convertible notes
mature on the five-year anniversary of their date of issuance. We may not redeem any of the convertible notes prior to maturity. See
Note 4 to the accompanying condensed consolidated financial statements for additional information.
Critical
Accounting Estimates
There
were no significant changes in our critical accounting estimates during the three months ended June 33, 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 June 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 10—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, we do
not believe there is any litigation pending that could have, individually or in the aggregate, a material adverse effect on our results
of operations, financial condition or cash flows.
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, except as follows:
Our
failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.
As
previously reported, on March 19, 2024, we received a notice (the “Notice”) from
the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that we are not
in compliance with 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. Our stockholders’ equity was $2.2 million as of
December 31, 2023. The Notice had no immediate effect on our Nasdaq listing.
In
May 2024, we submitted a plan to the Staff advising of actions we have taken or will take to regain compliance with the Minimum
Stockholders’ Equity Rule. The Staff accepted the plan and granted us a 180-day extension, or through September 16, 2024, to
regain compliance with the Minimum Stockholders’ Equity Rule. If we are unable to demonstrate
compliance on or before September 16, 2024, Nasdaq would be required to issue a delisting determination. In such
event, we may be entitled to request a hearing before a Nasdaq Hearings Panel to appeal such determination.
We
can provide no assurance that we will be able to regain compliance with the Minimum Stockholders’ Equity Rule on
or before September 16, 2024, or that we will be able to continue to satisfy any other continued listing requirements
of Nasdaq.
If
our common stock is delisted by Nasdaq, and we are not able to list our securities on another national securities exchange, we expect
our securities could be quoted on an over-the-counter market. If this were to occur, then we could face significant material adverse
consequences, including: a material reduction in the liquidity of our common stock and a corresponding material reduction in the trading
price of our common stock; a more limited market quotations for our securities; a determination that our common stock is a “penny
stock” that requires brokers to adhere to more stringent rules and possibly resulting in a reduced level of trading activity in
the secondary trading market for our securities; more limited research coverage by stock analysts; loss of reputation; more difficult
and more expensive equity financings in the future; the potential loss of confidence by investors; and fewer business development opportunities.
The
National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the
sale of certain securities, which are referred to as “covered securities.” If our common stock remains listed on Nasdaq,
our common stock will be covered securities. Although the states are preempted from regulating the sale of our securities, the federal
statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity,
then the states can regulate or bar the sale of covered securities in a particular case. If our securities were no longer listed on Nasdaq
and therefore not “covered securities,” we would be subject to regulation in each state in which we offer our securities.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
Applicable.
Item
5. Other Information.
(a)
In October 2022, we entered into a sublease with a subsidiary of Bristol-Myers Squibb Company, as sublessor, for office, laboratory and
research and development space of approximately 45,500 square feet in Somerville, Massachusetts.
As previously reported, on May
3, 2024, we received a notice from the sublessor regarding past due rent of approximately $2.3 million that we 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 constituted an event of default under the sublease We also did not pay
the rent for June, July or August 2024 and, as of August 1, 2024, we owed approximately $4.0 million in the aggregate in past due rent.
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, 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.
The initial term of the sublease
was for 10 years that would have expired in November 2033. The sublease called for base rental payments of approximately $0.5 million
per month as well as monthly payments for parking and our share of traditional lease expenses, including certain taxes, operating expenses
and utilities. As a result of the sublease termination, we expect to save approximately $58.5 million in base rental payments plus parking,
operating expenses, taxes and utilities that we would have paid over the remaining lease term.
We do not expect that the termination
of the sublease will impact our current business needs.
(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
* |
Indicates management contract or compensatory plan. |
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:
August 13, 2024 |
By: |
/s/
Sanjeev Luther |
|
|
Sanjeev
Luther |
|
|
President
and Chief Executive Officer |
|
|
(Principal
Executive Officer) |
Date:
August 13, 2024 |
By: |
/s/
Sandra Gurrola |
|
|
Sandra
Gurrola |
|
|
Senior
Vice President of Finance |
|
|
(Principal
Financial Officer and Principal Accounting Officer) |
Exhibit
10.1
ETERNA
THERAPEUTICS INC.
RESTATED
2020 STOCK INCENTIVE PLAN
AWARD
AGREEMENT
Notice
of Restricted Stock Grant
Eterna
Therapeutics Inc. (the “Company”) has awarded to you (“Participant”) the number of shares of Restricted
Stock set forth below under the Company’s Restated 2020 Stock Incentive Plan (the “Plan”).
Participant
Name: |
|
[ ] |
|
|
|
Grant
ID: |
|
[ ] |
|
|
|
Grant
Date: |
|
[ ] |
|
|
|
Number
of Shares of Restricted Stock: |
|
[ ] |
|
|
|
Amount
Paid by Participant for the Shares of Restricted Stock: |
|
[ ] |
|
|
|
Aggregate
Fair Market Value of Restricted Stock on Date of Restricted Stock Grant: |
|
[ ] |
|
|
|
Country
at Grant: |
|
[ ] |
|
|
|
Vesting
Commencement Date: |
|
[ ] |
|
|
|
Vesting
Schedule: |
|
[ ] |
Capitalized
terms used but not defined in this Notice of Restricted Stock Grant (this “Notice”) or the attached Restricted Stock
Terms and Conditions (including any appendices and exhibits attached thereto) will have the same meanings specified in the Plan. This
Notice and the Restricted Stock Terms and Conditions are collectively referred to as the “Award Agreement” applicable
to the Restricted Stock.
By
accepting (whether electronically or otherwise) this grant of Restricted Stock, Participant acknowledges and agrees to the following:
|
1. |
This grant of Restricted
Stock is governed by all the terms and conditions of the Award Agreement and the Plan applicable to the grant of Restricted Stock,
whether or not such terms and conditions are stated in the Award Agreement. The text of the Plan is incorporated herein by this reference.
In the event of a conflict between the terms of the Plan and the Award Agreement, the terms of the Plan will prevail. |
The
Award Agreement, any exhibits attached thereto, and the Plan constitute the entire understanding between the Participant and the Company
regarding this grant of Restricted Stock. Any prior agreements, commitments or negotiations are superseded.
The
Participant and the Company agree to execute such further instruments and to take such further action as may reasonably be necessary
to carry out the intent of the Award Agreement.
|
2. |
Participant has received
a copy of the Plan, this Award Agreement, the Plan prospectus (if required under applicable law), and the Company’s insider trading
policy, the Company’s clawback policy, and represents that he or she has read these documents and is familiar with their terms.
Participant further agrees to accept as binding, conclusive, and final all decisions and interpretations of the Committee regarding
any questions relating to this grant of Restricted Stock and the Plan. |
|
|
|
|
3. |
Vesting of the Restricted
Stock is subject to Participant’s continued [employment] [service] as [an] [a] [employee] [director] [consultant], which is for
an unspecified duration and may be terminated at any time, with or without Cause, and nothing in this Award Agreement or the Plan changes
the nature of that relationship. |
|
|
|
|
4. |
The Company is not providing
any tax, legal, or financial advice, nor is the Company making any recommendations regarding participation in the Plan. Participant
should consult with his or her own personal tax, legal, and financial advisors regarding participation in the Plan before taking any
action related to the Plan. |
|
|
|
|
5. |
Participant consents to electronic
delivery and participation as set forth in this Award Agreement. |
|
|
|
|
6. |
If Participant does not
accept or decline this grant of Restricted Stock within 60 days of the Grant Date or by such other date that may be communicated to
Participant by the Company, the Company will accept the grant of Restricted Stock on Participant’s behalf and Participant will
be deemed to have accepted the terms and conditions of the Restricted Stock set forth in the Plan and this Award Agreement. If Participant
wishes to decline this grant of Restricted Stock, Participant should promptly notify [__] at [__]@eternatx.com. If Participant declines
this grant of Restricted Stock, the Restricted Stock will be cancelled and no benefits from the Restricted Stock nor any compensation
or benefits in lieu of the Restricted Stock will be provided to Participant. |
Eterna
Therapeutics Inc. |
|
Participant |
|
|
|
By:
|
|
|
Signature:
|
|
Title:
|
|
|
Date:
|
|
ETERNA
THERAPEUTICS INC.
RESTATED
2020 STOCK Incentive Plan
award
agreement
Restricted
Stock Terms and Conditions
1.
Grant of Restricted Stock. The Company awards the Participant the number of shares of Restricted Stock shown on the accompanying
Notice of Restricted Stock Grant (the “Notice”). This Restricted Stock Grant is not intended to constitute a nonqualified
deferred compensation plan within the meaning of section 409A of the Code and will be interpreted accordingly. Notwithstanding the foregoing,
no member of the Company Group shall be liable for any costs incurred by Participant under Section 409A of the Code and/or similar state
laws.
2.
Vesting. This Award will vest according to the Vesting Schedule set forth on the Notice. The period over which the
Award vests is referred to as the “Restricted Period”.
3.
[Change in Control; Acceleration]. [In the event of a Change in Control, and provided that the Participant is employed
by (or rendering services to) the Company continuously from the Grant Date through the effective date of the Change of Control, 100%
of the then unvested portion of this Award shall vest as of immediately prior to the effective date of such Change in Control.]
4.
Dividend and Voting Rights. Unless otherwise provided in an Award Agreement, until the expiration of the Restricted Period:
4.1
(i) the Restricted Stock shall be treated as outstanding, (ii) the Participant holding shares of Restricted Stock may exercise full voting
rights with respect to such shares, and (iii) subject to Section 4.2, the Participant holding shares of Restricted Stock shall be entitled
to receive all dividends and other distributions paid with respect to such shares while they are so held; and
4.2
all dividends and distributions in respect of the Restricted Stock shall be held in escrow by the Company and subject to the same vesting
terms and conditions as the shares of Restricted Stock and such dividends shall only be paid to the Participant upon vesting of the underlying
shares of Restricted Stock; if any such dividends or distributions are paid in shares of Common Stock, such shares shall be subject to
the same restrictions on transferability and forfeitability as the shares of Restricted Stock with respect to which they were paid; and
4.3
if the Participant forfeits any rights the Participant has under this Award in accordance with Section 6, the Participant shall, on the
date of such forfeiture, no longer have any rights as a stockholder with respect to the shares of Restricted Stock evidenced by this
Award and shall no longer be entitled to vote or receive dividends on such shares.
5.
Certificates; Book Entry; Escrow. The Company may issue stock certificates or evidence the Participant’s interest
in this Award by using a restricted book entry account with the Company’s transfer agent, with legends, or notations, as applicable,
referring to the terms, conditions and restrictions applicable to this Award. Physical possession or custody of any stock certificates
that are issued evidencing the shares of Restricted Stock subject of this Award shall be retained by the Company until such time as the
Restricted Stock vests. Any such certificate(s) shall be deposited in escrow with the Secretary of the Company (or his/her designee)
to be held in accordance with the provisions of this Section. Each deposited certificate shall be accompanied by a duly executed Assignment
Separate from Certificate in the form attached hereto as Exhibit A. The deposited certificates shall remain in escrow until such
time as the certificates are to be released or otherwise surrendered for cancellation as discussed below.
The
Restricted Stock held in escrow hereunder shall be subject to the following terms and conditions relating to their release from escrow
or their surrender to the Company, provided, however, that the minimum number of shares released to the Participant in any individual
release of share certificates must be at least twenty-five (25) shares (unless the release represents the final release of share certificates
from escrow to Participant):
When
the Participant’s interest in shares of Restricted Stock vests, the Company shall, as applicable, either remove the notations on
any such shares of Restricted Stock issued in book entry form or deliver to Participant a stock certificate representing a number of
shares of Common Stock, equal to the number of shares of Restricted Stock with respect to which have become vested.
6.
Non-Transferability. Subject to any exceptions set forth in the Award Agreement or the Plan, during the Restricted Period,
neither this Award nor the rights relating thereto may be sold, anticipated, assigned, attached, garnished, optioned, transferred, alienated,
pledged, or otherwise transferred or encumbered by the Participant or made subject to any creditor’s process, whether voluntarily,
involuntarily or by operation of law. Any attempt to do any of the foregoing, during the Restricted Period shall be wholly ineffective
and, if any such attempt is made, this Award will be automatically forfeited by the Participant and all of the Participant’s rights
to and under this Award shall immediately terminate without any payment or consideration by the Company. The terms of the Plan and this
Award Agreement will be binding upon the executors, administrators, heirs, successors, and assigns of Participant.
7.
Code Section 83(b) Election. The Participant represents and warrants that the Participant understands the Federal,
state and local income tax consequences of the granting of this Award. The Grantee may make an election under Code Section 83(b) (a “Section
83(b) Election”) with respect to the unvested shares of Restricted Stock subject to this Award. Any such election must be made
within thirty (30) days after the Grant Date. If the Participant elects to make a Section 83(b) Election, the Participant shall provide
the Company with a copy of an executed version and satisfactory evidence of the filing of the executed Section 83(b) Election with the
US Internal Revenue Service within ten days such filing. The Participant agrees to assume full responsibility for ensuring that the Section
83(b) Election is actually and timely filed with the US Internal Revenue Service and for all tax consequences resulting from the Section
83(b) Election. THE PARTICIPANT ACKNOWLEDGES THAT IT IS THE PARTICIPANT’S SOLE DECISION AND RESPONSIBILITY, AND NOT THE COMPANY’S,
TO FILE A TIMELY ELECTION UNDER CODE SECTION 83(b), EVEN IF THE PARTICIPANT REQUESTS THE COMPANY OR ITS REPRESENTATIVES TO MAKE (OR ASSIST
IN MAKING) THIS FILING ON THE PARTICIPANT’S BEHALF. MOREOVER, THE PARTICIPANT IS RELYING SOLELY ON THE PARTICIPANT’S OWN
ADVISORS WITH RESPECT TO THE DECISION AS TO WHETHER OR NOT TO FILE A SECTION 83(b) ELECTION.
8.
[Leaves of Absence. For purposes of this Award Agreement, while the Participant is a common-law employee, the Participant’s
service does not terminate when the Participant goes on a bona fide leave of absence that was approved by the Committee in writing,
if the terms of the leave provide for continued Service crediting, or when continued service crediting is required by applicable law.
The Participant’s service terminates in any event when the approved leave ends, unless the Participant immediately returns to active
work. The Committee shall determine which leaves count for this purpose (along with determining the effect of a leave of absence on vesting
of the Restricted Stock), and when the Participant’s service terminates for all purposes under the Plan.] [Intentionally
Omitted.]1
1
First alternative to be used if the Participant is an employee.
9.
Restrictions on Issuance. The Company will not issue any Restricted Stock or shares of Common Stock if the issuance
thereof at that time would violate any law or regulation.
10.
Taxes and Withholding.
10.1
Responsibility for Taxes. By accepting this Award, the Participant acknowledges that, regardless of any action taken by
the Company or, if different, any member of the Company Group that employs Participant (the “Employer”), the ultimate liability
for all Taxes is and remains the Participant’s responsibility and may exceed the amount actually withheld by the Company or the
Employer. The Participant further acknowledges that the Company and/or the Employer (i) make no representations or undertakings regarding
the treatment of any Taxes in connection with any aspect of this Award, including, but not limited to, the grant, vesting, or settlement
of this Award, the subsequent sale of shares underlying this Award, and the receipt of any dividends; and (ii) do not commit to and are
under no obligation to structure the terms of the grant or any aspect of this Award to reduce or eliminate the Participant’s liability
for Taxes or achieve any particular tax result. Further, if the Participant is subject to Taxes in more than one jurisdiction, as applicable,
the Participant acknowledges that the Company and/or the Employer may be required to withhold or account for Taxes in more than one jurisdiction.
The Participant agrees to pay to the Company or the Employer any amount of Taxes that the Company or the Employer may be required to
withhold or account for as a result of this Award that cannot be satisfied by the means described in this Section. The Company may refuse
to issue or deliver the shares underlying this Award, or the proceeds of the sale of such shares, if the Participant fails to comply
with its obligations in connection with the Taxes.
10.2
Withholding. Prior to the relevant taxable or Taxes withholding event, as applicable, the Participant agrees to make adequate
arrangements satisfactory to the Company and/or the Employer to satisfy all Taxes. In this regard, the Participant authorizes the Company
or the Employer, or their respective agents, at their discretion, to satisfy the obligations with regard to all Taxes by one or a combination
of the following: (i) withholding from the Participant’s wages or other cash compensation paid to the Participant by the Company
and/or the Employer or any member of the Company Group; (ii) withholding from proceeds of the sale of the shares underlying this Award
either through a voluntary sale or through a mandatory sale arranged by the Company (on the Participant’s behalf pursuant to this
authorization and without further consent); (iii) withholding shares underlying this Award, provided the Company only withholds a number
of shares necessary to satisfy no more than the withholding amounts determined based on the maximum permitted statutory rate applicable
in Participant’s jurisdiction; (iv) the Participant’s payment of a cash amount (including by check representing readily available
funds or a wire transfer); or (v) any other arrangement approved by the Committee and permitted under applicable law.
Withholding
for Taxes will be made in accordance with Section 13(c) of the Plan and such rules and procedures as may be established by the Committee,
and in compliance with the Company’s insider trading policy, if applicable. In the event the Company or the Employer withholds
more than the Taxes using one of the methods described above, the Participant may receive a refund of any over-withheld amount in cash
but will have no entitlement to the shares sold or withheld.
11.
Restrictions on Resale. By signing this Award Agreement, the Participant agrees not to sell, transfer, dispose of,
pledge, hypothecate, make any short sale of, or otherwise effect a similar transaction of any shares acquired under this Award Agreement
(each a “Sale Prohibition”) at a time when applicable laws, regulations or Company or underwriter trading policies prohibit
the disposition of shares.
The
Company shall have the right to designate one or more periods of time, each of which generally will not exceed one hundred eighty (180)
days in length (provided however, that such period may be extended in connection with the Company’s release (or announcement of
release) of earnings results or other material news or events), and to impose a Sale Prohibition, if the Company determines (in its sole
discretion) that such limitation(s) is needed in connection with a public offering of shares or to comply with an underwriter’s
request or trading policy, or could in any way facilitate a lessening of any restriction on transfer pursuant to the Securities Act of
1933 (“Securities Act”) or any state securities laws with respect to any issuance of securities by the Company, facilitate
the registration or qualification of any securities by the Company under the Securities Act or any state securities laws, or facilitate
the perfection of any exemption from the registration or qualification requirements of the Securities Act or any applicable state securities
laws for the issuance or transfer of any securities. The Company may issue stop/transfer instructions and/or appropriately legend any
stock certificates issued pursuant to this Restricted Stock Grant in order to ensure compliance with the foregoing. Any such Sale Prohibition
shall not alter the vesting schedule set forth in this Agreement.
If
the sale of shares under the Plan is not registered under the Securities Act, but an exemption is available which requires an investment
or other representation, the Participant shall represent and agree at the time of grant of the Restricted Stock that the shares being
acquired under this Award Agreement are being acquired for investment, and not with a view to the sale or distribution thereof, and shall
make such other representations as are deemed necessary or appropriate by the Company and its counsel.
The
Participant may also be required, as a condition of this Award Agreement, to enter into any Company stockholder agreement or other agreements
that are applicable to stockholders.
12.
No Retention Rights. Neither this Award nor this Award Agreement gives the Participant the right to be retained by the
Company Group in any capacity. The Company Group the right to terminate the Participant’s service at any time and for any reason.
13.
Extraordinary Compensation. In accepting this Award, Participant acknowledges, understands and agrees that: (a) the Plan
is established voluntarily by the Company, is discretionary in nature, and may be amended, suspended or terminated by the Company at
any time, to the extent permitted by the Plan; (b) the grant of this Award is voluntary and occasional and does not create any contractual
or other right to receive future grants, or benefits in lieu of grants, even if grants have been made in the past; (c) all decisions
with respect to future grants of Awards, if any, will be at the sole discretion of the Company; (d) the Participant is voluntarily receiving
this Award; (e) this Award and the shares underlying this Award are not intended to replace any pension rights or compensation and are
outside the scope of the Participant’s employment contract, if any; (f) this Award and the shares underlying this Award, and the
income and value of same, are not part of normal or expected compensation for any purpose, including, without limitation, calculating
any severance, resignation, termination, redundancy, dismissal, end-of-service payments, bonuses, long-service awards, pension or retirement
or welfare benefits or similar payments; (g) unless otherwise provided in the Plan or by the Company in its discretion, this Award and
the benefits evidenced by this Award Agreement do not create any entitlement to have this Award or any such benefits transferred to,
or assumed by, another company nor to be exchanged, cashed out or substituted for, in connection with any corporate transaction affecting
the shares of the Company; and (h) neither the Company nor any member of the Company Group shall be liable for any foreign exchange rate
fluctuation between Participant’s local currency and the United States Dollar or the selection by the Company or any member of
the Company Group in its sole discretion of an applicable foreign exchange rate that may affect the value of this Award (or the calculation
of income or Taxes thereunder) or of any amounts due to Participant pursuant to the terms of this Award or the subsequent sale of the
shares underlying this Award.
14.
Adjustments. If the outstanding shares of Common Stock are increased or decreased or changed into or exchanged for a different
number or kind of shares or other securities by reason of any recapitalization, reclassification, reorganization, stock split, reverse
split, combination of shares, exchange of shares, stock dividend or other distribution payable in capital stock of the Company or other
increase or decrease in such shares effected without receipt of consideration by the Company, an appropriate and proportionate adjustment
shall be made to this Award by the Committee including to the number and kind of shares of Common Stock issuable pursuant to this Award.
15.
Legends. All certificates or book entries representing the Common Stock issued under this Award may, where applicable,
have endorsed thereon the following notations or legends and any other notation or legend the Company determines appropriate.
““SHARES
OF STOCK REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN TERMS, CONDITIONS, AND RESTRICTIONS ON TRANSFER AS SET FORTH IN THE ETERNA
THERAPEUTICS, INC. RESTATED 2020 STOCK INCENTIVE PLAN (THE “PLAN”), AND IN AN AGREEMENT ENTERED INTO BY AND BETWEEN THE REGISTERED
OWNER OF SUCH SHARES AND ETERNA THERAPEUTICS, INC. (THE “COMPANY”), DATED __ (THE “AWARD AGREEMENT”). A COPY
OF THE PLAN AND THE AWARD AGREEMENT MAY BE OBTAINED FROM THE SECRETARY OF THE COMPANY.”
“THE
SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER AND OPTIONS TO PURCHASE SUCH SHARES SET FORTH
IN AN AGREEMENT BETWEEN THE COMPANY AND THE REGISTERED HOLDER, OR HIS OR HER PREDECESSOR IN INTEREST. A COPY OF SUCH AGREEMENT IS ON
FILE AT THE PRINCIPAL OFFICE OF THE COMPANY AND WILL BE FURNISHED UPON WRITTEN REQUEST TO THE SECRETARY OF THE COMPANY BY THE HOLDER
OF RECORD OF THE SHARES REPRESENTED BY THIS CERTIFICATE.”
“THE
SHARES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, PLEDGED, OR OTHERWISE
TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION THEREOF UNDER SUCH ACT OR AN OPINION OF COUNSEL, SATISFACTORY TO THE COMPANY AND ITS COUNSEL,
THAT SUCH REGISTRATION IS NOT REQUIRED.”
16.
Notice. Any communication or notice relating to this Award Agreement shall be in writing, and mailed by registered
or certified mail or delivered by hand, to the Company, to its principal place of business, attention: Chief Financial Officer, and if
to the Participant, to the Participant’s address as appearing on the records of the Company. All notices shall be deemed effective
upon personal delivery or upon deposit in the U.S. mail, postage prepaid and properly addressed to the party to be notified.
17.
Voluntary Participant. Participant acknowledge that the Participant is voluntarily participating in the Plan.
18.
No Rights to Future Awards. The Participant’s rights, if any, in respect of or in connection with any future Restricted
Stock are derived solely from the discretionary decision of the Company to permit the Participant to participate in the Plan and to benefit
from a discretionary future Restricted Stock. By accepting this Award, the Participant expressly acknowledges that there is no obligation
on the part of the Company to continue the Plan and/or grant any additional Awards to the Participant or benefits in lieu of any other
Award even if Awards have been granted repeatedly in the past. All decisions with respect to future Awards, if any, will be at the sole
and absolute discretion of the Committee.
19.
Future Value. The future value of the shares underling this Award is unknown and cannot be predicted with certainty. If
the underlying shares do not increase in value after the Grant Date, this Award will have less value (or even no value) than it may have
on the Grant Date.
20.
No Advice Regarding Restricted Stock Grant. The Company has not provided any tax, legal or financial advice, nor has the
Company made any recommendations regarding the Participant’s participation in the Plan, or the Participant’s acquisition
or sale of the shares underlying this Award. The Participant is hereby advised to consult with its own personal tax, legal and financial
advisors regarding the Participant’s participation in the Plan before taking any action related to the Plan.
21.
Clawback. By accepting this Award, the Participant acknowledges that the Participant is fully bound by, and subject to
all of the terms and conditions of, the clawback policy adopted by the Company, as the same may be amended, modified or restated from
time to time (the “Clawback Policy”), and the Participant agrees to abide by the terms of any the Clawback Policy. To the
extent that the Committee determines that all or a portion of this Award or the shares of Common Stock issued in respect of this Award
must be cancelled, forfeited, repaid, or otherwise recovered by the Company, the Participant shall promptly take whatever action is necessary
to effectuate such cancellation, forfeiture, repayment, or recovery. No recovery of all or a portion of this Award or the shares of Common
Stock issued in respect of this award under the Clawback Policy will be an event giving rise to a right to terminate for Good Reason
(or any similar defined term) under any agreement with the Company. In the event of any conflicts between the terms of the Clawback Policy
and the terms of the Plan or this Award Agreement, the terms of the Clawback Policy shall govern.
22.
Other Information. The Participant agrees to receive stockholder information, including copies of any annual report, proxy
statement and periodic report, from the SEC Filings section in the Investor Relations section of the Company’s website at www.eternatx.com.
The Participant acknowledges that copies of the Plan, Plan prospectus, Plan information and stockholder information are also available
upon written or telephonic request to the Company’s Plan administrator.
23.
Data Privacy. Participant hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic
or other form, of Participant’s personal data as described in this Award Agreement and any other grant materials by and among the
Company and the members of the Company Group for the purpose of implementing, administering and managing Participant’s participation
in the Plan. Participant understands that the Company and the members of the Company Group may hold certain personal information about
Participant, including, but not limited to, Participant’s name, home address and telephone number, date of birth, social insurance
number or other identification number, salary, nationality, job title, any shares or directorships held in the Company, details of all
grants, or any other entitlement to shares awarded, cancelled, received, vested, unvested or outstanding in Participant’s favor
(“Data”), for the purpose of implementing, administering and managing the Plan. Participant understands that Data will be
transferred to such stock plan service provider as may be selected by the Company, presently or in the future, which may be assisting
the Company with the implementation, administration and management of the Plan. Participant understands that the recipients of the Data
may be located in the United States or elsewhere, and that the recipient’s country (e.g., the United States) may have different
data privacy laws and protections than Participant’s country. Participant authorizes the Company, the stock plan service provider
as may be selected by the Company, and any other possible recipients which may assist the Company, presently or in the future, with implementing,
administering and managing the Plan to receive, possess, use, retain and transfer the Data, in electronic or other form, for the purposes
of implementing, administering and managing the Plan. Further, Participant understands that he or she is providing the consents herein
on a purely voluntary basis. If Participant does not consent, or if Participant later seeks to revoke his or her consent, or instructs
the Company to cease the processing of the Data, his or her employment or service will not be adversely affected; the only adverse consequence
of refusing or withdrawing Participant’s consent or instructing the Company to cease processing, is that the Company would not
be able to grant Participant this Award or any other equity awards or administer or maintain such awards. Therefore, Participant understands
that refusing or withdrawing his or her consent may affect Participant’s ability to participate in the Plan. For more information
on the consequences of Participant’s refusal to consent or withdrawal of consent, Participant understands that he or she may contact
his or her local human resources representative.
24.
Applicable Law. This Award Agreement shall be governed by and construed and interpreted in accordance with the laws of
the State of Delaware, without giving effect to principles of conflicts of law. For purposes of litigating any dispute that arises directly
or indirectly from the relationship of the parties evidenced by this grant or this Award Agreement, the parties hereby submit to the
exclusive jurisdiction of the State of Delaware and agree that such litigation shall be conducted only in the courts of the State of
Delaware, or the federal courts for the United States for the District of Delaware, and no other courts, where this grant is made and/or
to be performed.
25.
Addendum and Sub-Plans. Notwithstanding any provisions in this Award Agreement, this Award shall be subject to any special
terms and conditions set forth in any Addendum to this Award Agreement for Participant’s country. Moreover, if Participant relocates
to one of the countries included in the Addendum (if any), the special terms and conditions for such country will apply to Participant,
to the extent the Company determines that the application of such terms and conditions is necessary or advisable for legal or administrative
reasons. The Addendum (if any) constitutes part of this Award Agreement. Further, the Plan shall be deemed to include any special terms
and conditions set forth in any applicable sub-plan for Participant’s country, and, if Participant relocates to a country for which
the Company has established a sub-plan, the special terms and conditions for such country will apply to Participant, to the extent the
Company determines that the application of such terms and conditions is necessary or advisable for legal or administrative reasons.
26.
Enforcement of Rights; Amendment. Except as contemplated by the Plan, no modification of or amendment to this Award Agreement,
nor any waiver of any rights under this Award Agreement, shall be effective unless in writing signed by the parties to this Award Agreement
to the extent it would alter or impair rights or obligations under this Award Agreement. The failure by either party to enforce any rights
under this Award Agreement shall not be construed as a waiver of any rights of such party. Notwithstanding anything to the contrary in
the Plan or this Award Agreement, the Company reserves the right to revise this Award Agreement as it deems necessary or advisable, in
its sole discretion and without the consent of Participant, to comply with Section 409A of the Code or to otherwise avoid imposition
of any additional tax or income recognition or costs under Section 409A of the Code in connection with this Award.
27.
Severability. If one or more provisions of this Award Agreement are held to be unenforceable under applicable laws, the
parties agree to renegotiate such provision in good faith. In the event that the parties cannot reach a mutually agreeable and enforceable
replacement for such provision, then (a) such provision shall be excluded from this Award Agreement, (b) the balance of this Award Agreement
shall be interpreted as if such provision were so excluded, and (c) the balance of this Award Agreement shall be enforceable in accordance
with its terms.
28.
Language. If Participant has received this Award Agreement, the Plan or any other document related to this Award and/or
the Plan translated into a language other than English and if the meaning of the translated version is different than the English version,
the English version will control.
29.
Imposition of Other Requirements. The Company reserves the right to impose other requirements on Participant’s participation
in the Plan, on this Award and on any shares received under this Award, to the extent the Company determines it is necessary or advisable
for legal or administrative reasons, and to require Participant to accept any additional agreements or undertakings that may be necessary
to accomplish the foregoing.
30.
Counterparts. This Award Agreement may be executed in two or more counterparts, each of which shall be deemed an original
and all of which together shall constitute one instrument. Facsimile, email or other electronic execution and delivery of this Award
Agreement (including but not limited to execution by electronic signature or click-through electronic acceptance) shall constitute valid
and binding execution and delivery for all purposes and shall be deemed to be, and have the effect of, an original signature.
31.
Successors and Assigns. The rights and benefits of this Award Agreement shall inure to the benefit of, and be enforceable
by the Company’s successors and assigns.
32.
Consent to Electronic Delivery and Participation. By accepting this Award, Participant agrees to participate in the Plan
through an on-line or electronic system established and maintained by the Company or a third party designated by the Company, and consents
to the electronic delivery of the Award Agreement, the Plan, account statements, Plan prospectuses (if any), and all other documents,
communications, or information related to the RSUs and current or future participation in the Plan. Electronic delivery may include the
delivery of a link to the Company intranet or the internet site of a third party involved in administering the Plan, the delivery of
the document via e-mail or such other delivery determined at the Company’s discretion. Participant acknowledges that Participant
may receive from the Company a paper copy of any documents delivered electronically at no cost if Participant contacts the Company by
telephone, through a postal service, or electronic mail to the Company’s stock plan administrator.
EXHIBIT
A
ASSIGNMENT
SEPARATE FROM CERTIFICATE
FOR
VALUE RECEIVED and pursuant to that certain Restricted Stock Grant Agreement dated as of [
], the undersigned hereby sells, assigns and transfers unto [ ] [ ]
shares of the Common Stock of Eterna Therapeutics Inc., a Delaware corporation, standing in the undersigned’s name on the books
of said corporation, herewith, and does hereby irrevocably constitute and appoint _____________ attorney-in-fact to transfer the said
stock on the books of the said corporation with full power of substitution in the premises.
Dated:
[Month] [Day], 20_____
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:
August 13, 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:
August 13, 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 June 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:
August 13, 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 June 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:
August 13, 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.
v3.24.2.u1
Cover - $ / shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 09, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
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
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
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Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
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Entity Common Stock, Shares Outstanding |
|
5,410,588
|
Entity Listing, Par Value Per Share |
$ 0.005
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 2,586
|
$ 7,575
|
Other receivables |
228
|
425
|
Prepaid expenses and other current assets |
769
|
1,599
|
Total current assets |
3,583
|
9,599
|
Restricted cash |
4,095
|
4,095
|
Property and equipment, net |
654
|
493
|
Right-of-use assets - operating leases |
35,990
|
32,781
|
Goodwill |
2,044
|
2,044
|
Other assets |
120
|
120
|
Total assets |
46,486
|
49,132
|
Current liabilities: |
|
|
Accounts payable |
2,193
|
1,067
|
Accrued expenses |
2,389
|
1,893
|
Income taxes payable |
7
|
2
|
Operating lease liabilities, current |
4,266
|
2,216
|
Due to related party, current |
331
|
1,205
|
Deferred revenue, current |
189
|
190
|
Other current liabilities |
225
|
|
Total current liabilities |
9,600
|
6,573
|
Convertible notes, net |
8,895
|
6,773
|
Warrant liabilities |
50
|
116
|
Operating lease liabilities, non-current |
36,044
|
32,854
|
Deferred revenue, non-current |
298
|
392
|
Contingent consideration liability |
41
|
107
|
Other liabilities |
84
|
84
|
Total liabilities |
55,012
|
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 June 30, 2024 and December 31, 2023, $156 liquidation preference |
1
|
1
|
Common stock, $0.005 par value, 100,000 shares authorized at June 30, 2024 and December 31, 2023; 5,411 and 5,410 issued and outstanding at June 30, 2024 and December 31, 2023, respectively |
27
|
27
|
Additional paid-in capital |
190,611
|
189,186
|
Accumulated deficit |
(199,165)
|
(186,981)
|
Total stockholders’ (deficit) equity |
(8,526)
|
2,233
|
Total liabilities and stockholders’ (deficit) equity |
$ 46,486
|
$ 49,132
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) shares in Thousands, $ in Thousands |
Jun. 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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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenue |
$ 47
|
|
$ 94
|
|
Cost of revenues |
95
|
|
156
|
50
|
Gross loss |
(48)
|
|
(62)
|
(50)
|
Operating expenses: |
|
|
|
|
Research and development |
987
|
1,499
|
2,445
|
3,173
|
General and administrative |
3,896
|
2,590
|
8,211
|
6,182
|
Acquisition of Exacis in-process research and development |
|
460
|
|
460
|
Total operating expenses |
4,883
|
4,549
|
10,656
|
9,815
|
Loss from operations |
(4,931)
|
(4,549)
|
(10,718)
|
(9,865)
|
Other (expense) income, net: |
|
|
|
|
Change in fair value of warrant liabilities |
136
|
191
|
66
|
146
|
Change in fair value of contingent consideration |
66
|
118
|
66
|
118
|
Loss on non-controlling investment |
|
(8)
|
|
(59)
|
Interest (expense) income, net |
(797)
|
24
|
(1,583)
|
25
|
Other expense, net |
|
(280)
|
|
(280)
|
Total other (expense) income, net |
(595)
|
45
|
(1,451)
|
(50)
|
Loss before income taxes |
(5,526)
|
(4,504)
|
(12,169)
|
(9,915)
|
Provision for income taxes |
(3)
|
(4)
|
(7)
|
(9)
|
Net loss |
(5,529)
|
(4,508)
|
(12,176)
|
(9,924)
|
Series A preferred stock dividend |
(8)
|
(8)
|
(8)
|
(8)
|
Net loss attributable to common stockholders |
$ (5,537)
|
$ (4,516)
|
$ (12,184)
|
$ (9,932)
|
Net loss per common share - basic |
$ (1.02)
|
$ (0.85)
|
$ (2.25)
|
$ (1.90)
|
Net loss per common share - diluted |
$ (1.02)
|
$ (0.85)
|
$ (2.25)
|
$ (1.90)
|
Weighted average shares outstanding - basic |
5,410
|
5,303
|
5,410
|
5,215
|
Weighted average shares outstanding - diluted |
5,410
|
5,303
|
5,410
|
5,215
|
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v3.24.2.u1
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 |
Balance at Dec. 31, 2022 |
$ 1
|
$ 26
|
$ 177,377
|
$ (165,297)
|
$ 12,107
|
Balance, shares at Dec. 31, 2022 |
156
|
5,127
|
|
|
|
Stock-based compensation |
|
|
903
|
|
903
|
Cash dividends to Series A preferred stockholders |
|
|
|
(8)
|
(8)
|
Net loss |
|
|
|
(9,924)
|
(9,924)
|
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
|
|
|
|
Balance at Jun. 30, 2023 |
$ 1
|
$ 27
|
179,067
|
(175,229)
|
3,866
|
Balance, shares at Jun. 30, 2023 |
156
|
5,410
|
|
|
|
Balance at Mar. 31, 2023 |
$ 1
|
$ 26
|
178,066
|
(170,713)
|
7,380
|
Balance, shares at Mar. 31, 2023 |
156
|
5,127
|
|
|
|
Stock-based compensation |
|
|
214
|
|
214
|
Cash dividends to Series A preferred stockholders |
|
|
|
(8)
|
(8)
|
Net loss |
|
|
|
(4,508)
|
(4,508)
|
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
|
|
|
|
Balance at Jun. 30, 2023 |
$ 1
|
$ 27
|
179,067
|
(175,229)
|
3,866
|
Balance, shares at Jun. 30, 2023 |
156
|
5,410
|
|
|
|
Balance at Dec. 31, 2023 |
$ 1
|
$ 27
|
189,186
|
(186,981)
|
2,233
|
Balance, shares at Dec. 31, 2023 |
156
|
5,410
|
|
|
|
Issuance of common stock from vested restricted stock units |
|
|
|
|
|
Issuance of common stock from vested restricted stock units, shares |
|
1
|
|
|
|
Stock-based compensation |
|
|
705
|
|
705
|
Cash dividends to Series A preferred stockholders |
|
|
|
(8)
|
(8)
|
Net loss |
|
|
|
(12,176)
|
(12,176)
|
Issuance of note warrants |
|
|
720
|
|
720
|
Balance at Jun. 30, 2024 |
$ 1
|
$ 27
|
190,611
|
(199,165)
|
(8,526)
|
Balance, shares at Jun. 30, 2024 |
156
|
5,411
|
|
|
|
Balance at Mar. 31, 2024 |
$ 1
|
$ 27
|
190,188
|
(193,628)
|
(3,412)
|
Balance, shares at Mar. 31, 2024 |
156
|
5,410
|
|
|
|
Issuance of common stock from vested restricted stock units |
|
|
|
|
|
Issuance of common stock from vested restricted stock units, shares |
|
1
|
|
|
|
Stock-based compensation |
|
|
423
|
|
423
|
Cash dividends to Series A preferred stockholders |
|
|
|
(8)
|
(8)
|
Net loss |
|
|
|
(5,529)
|
(5,529)
|
Balance at Jun. 30, 2024 |
$ 1
|
$ 27
|
$ 190,611
|
$ (199,165)
|
$ (8,526)
|
Balance, shares at Jun. 30, 2024 |
156
|
5,411
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Jun. 30, 2023 |
Cash flows from operating activities: |
|
|
|
|
|
Net loss |
$ (5,529)
|
$ (4,508)
|
$ (12,176)
|
|
$ (9,924)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
Depreciation and amortization |
|
|
83
|
|
42
|
Stock-based compensation |
|
|
705
|
|
903
|
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
|
Amortization of right-of-use asset |
|
|
1,036
|
|
83
|
(Gain) loss on disposal of fixed assets |
|
|
(2)
|
|
1
|
Accrued interest expense |
|
|
422
|
|
|
Paid-in-kind interest expense |
|
|
407
|
|
|
Amortization of debt discount and debt issuance costs |
|
|
919
|
|
|
Change in fair value of warrant liabilities |
(136)
|
(191)
|
(66)
|
|
(146)
|
Change in fair value of contingent consideration liability |
|
|
(66)
|
|
(118)
|
Loss on non-controlling investment |
|
8
|
|
|
59
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Other receivables |
|
|
197
|
|
(33)
|
Prepaid expenses and other current assets |
|
|
734
|
|
214
|
Other non-current assets |
|
|
1
|
|
(481)
|
Accounts payable and accrued expenses |
|
|
1,549
|
|
(454)
|
Operating lease liability |
|
|
995
|
|
(215)
|
Due to related party |
|
|
(874)
|
|
(875)
|
Deferred revenue |
|
|
(95)
|
|
250
|
Other liabilities |
|
|
225
|
|
80
|
Net cash used in operating activities |
|
|
(6,006)
|
|
(9,921)
|
Cash flows from investing activities: |
|
|
|
|
|
Purchase of property and equipment |
|
|
(350)
|
|
|
Proceeds received from the sale of fixed assets |
|
|
4
|
|
|
Net cash used in investing activities |
|
|
(346)
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
Proceeds received from the convertible notes financing |
|
|
1,405
|
|
|
Fees paid related to the convertible notes financing |
|
|
(34)
|
|
|
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 |
|
|
1,363
|
|
312
|
Net decrease in cash and cash equivalents |
|
|
(4,989)
|
|
(9,609)
|
Cash, cash equivalents and restricted cash at beginning of period |
|
|
11,670
|
$ 5,932
|
15,541
|
Total cash, cash equivalents and restricted cash at end of period |
6,681
|
5,932
|
6,681
|
$ 11,670
|
5,932
|
Cash paid during the period for: |
|
|
|
|
|
Interest |
|
|
6
|
|
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 |
|
|
584
|
|
|
Adjustment to lease liability and ROU asset due to remeasurement |
|
|
4,245
|
|
|
Property and equipment purchased but not paid |
|
|
18
|
|
|
Initial measurement of ROU assets |
|
|
|
|
34,410
|
Initial measurement of lease liability |
|
|
|
|
34,169
|
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 |
2,586
|
1,837
|
2,586
|
|
1,837
|
Restricted cash |
$ 4,095
|
$ 4,095
|
$ 4,095
|
|
$ 4,095
|
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v3.24.2.u1
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
|
6 Months Ended |
Jun. 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. is a life science company committed to realizing the potential of mRNA cell engineering to provide patients with
transformational new medicines. Eterna has in-licensed a portfolio of over 100
patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the
NoveSliceTM and UltraSliceTM gene-editing proteins, and the ToRNAdoTM mRNA delivery system, which
Eterna collectively refers to as our “mRNA technology platform.” Eterna refers to aspects of its mRNA technology
platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell reprogramming.” Eterna licenses
its mRNA technology platform from Factor Bioscience Limited (“Factor Limited”) under an exclusive license agreement. 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 six months ended June 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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v3.24.2.u1
LIQUIDITY AND CAPITAL RESOURCES
|
6 Months Ended |
Jun. 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,
including conducting clinical trials and providing general and administrative support for operations. As of June 30, 2024, the Company
had an unrestricted cash balance of approximately $2.6 million and an accumulated deficit of approximately $199.2 million. For the three
and six months ended June 30, 2024, the Company incurred a net loss of $5.5 million and $12.2 million, respectively, and for the six
months ended June 30, 2024, the Company used cash of $6.0 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 see Note 17 for additional information regarding the sublease termination agreement.
In
April 2023, the Company entered into a standby equity purchase agreement (the “SEPA”) 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 SEPA for gross proceeds of $0.3 million. No shares have
been sold under the SEPA during the three and six months ended June 30, 2024.
In
July and December 2023, the Company received $16.5
million in aggregate gross proceeds from the issuance of convertible notes and in January 2024 received an additional $1.4
million in gross proceeds from the issuance of additional convertible notes. See Note 5 for additional information regarding these
financings.
In
connection with preparing the accompanying condensed consolidated financial statements as of and for the three and six months ended June
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 SEPA, public or private equity offerings, debt financings,
out-licensing the Company’s intellectual property, strategic partnerships or other means. Other than the SEPA, 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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v3.24.2.u1
ASSET ACQUISITION
|
6 Months Ended |
Jun. 30, 2024 |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] |
|
ASSET ACQUISITION |
3) ASSET ACQUISITION
On
April 26, 2023, the Company entered into an asset purchase agreement (the “Exacis Purchase Agreement”), with 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 by and 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 an aggregate of 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 the following contingent payments:
| (i) | if,
at any time during the three-year period commencing on the closing date and ending on the
three-year anniversary of the closing date, the Company’s market capitalization equals
or exceeds $100.0 million for at least ten consecutive trading days, then the Company will
issue to Exacis a number of shares of common stock equal to (x) $2.0 million divided by (y)
the quotient of $100.00 million divided by the number of the Company’s then issued
and outstanding shares of common stock; |
| (ii) | if,
at any time during the three-year period commencing on the closing date and ending on the
three-year anniversary of the closing date, the Company’s market capitalization equals
or exceeds $200.0 million for at least ten consecutive trading days, then the Company will
issue to Exacis a number of additional shares of common stock equal to (x) $2.0 million divided
by (y) the quotient of $200.00 million divided by the number of the Company’s then
issued and outstanding shares of common stock (collectively with (i) above, the “Market
Cap Contingent Consideration”); and |
| (iii) | during
the five-year period commencing on the closing date and ending on the five-year anniversary
of the closing date, the Company will pay or deliver to Exacis 20% of all cash or other consideration
(collectively, “License Contingent Consideration”) actually received by the Company
during the five-year period from (i) third-party licensees or sublicensees of the intellectual
property rights acquired by the Company from Exacis pursuant to the Exacis Purchase Agreement,
or (ii) subject to certain exceptions, the sale of such intellectual property rights; provided,
that the License Contingent Consideration shall not in any event exceed $45.0 million. |
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 six months ended June 30, 2023.
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v3.24.2.u1
CONTRACT WITH CUSTOMER
|
6 Months Ended |
Jun. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
CONTRACT WITH CUSTOMER |
4) 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 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 obtains the sublicense, the Company would be entitled to receive additional license fees, including milestone
payments and royalties.
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 will make such purchases. Therefore, 100% of the
Option Fee was allocated to the Option Right. The Option Fee will remain in deferred revenue until such time that Lineage enters into
the sublicense or when the Option Right expires.
The
Option Right and the cell line customization activities are accounted for as separate contracts, and the Company has determined that
the amended terms discussed above represent 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
will make payments to the Company for the cell line customization activities over the development period. The Company will only earn
the remaining full amount of the cell line customization fee if it makes certain progress towards delivery of the customized cell
line. The Company has determined that $0.4
million of consideration received could be recognized without the probability of being reversed, and it has placed a constraint on
the remaining contractual customization fee. The $0.4
million is being recognized equally over the development period, which is expected to be approximately 20 to 25 months, as the level
of effort to perform the services is happening at the same rate over time. If the development period is expected to be longer or
shorter than originally planned, the Company will recognize a cumulative catch-up adjustment in the period that such determination
is made. For the three and six months ended June 30, 2024, the Company recognized less than $0.1
million and $0.1
million of revenue, respectively, for the customization activities. The Company did not
recognize any revenue for either of the three or six months ended June 30, 2023.
The
granting of the license that the Company may provide to Lineage if Lineage exercises the Option Right is not considered a performance
obligation at this time, as it is an optional request that the customer may make in the future and will be accounted for as a separate
contract when the customer exercises the Option Right.
The
Company recognizes
direct labor and supplies used in the customization activities as incurred and are recorded as a cost of revenue. As provided
for in the A&R Factor License Agreement discussed in Note 9, the Company is obligated to pay Factor Limited 20% of any amounts the
Company receives from a customer that is related to the licensed technology under the A&R Factor License Agreement, which is also
recorded as a cost of revenue. For the six months ended June 30, 2023, the Company recognized less than $0.1 million in license fees,
which is recorded in cost of revenues, due to Factor Limited as a result of receiving the $0.3 million Option Fee payment from Lineage.
There was no such license fee incurred during the three months ended June 30, 2023 or during the three or six months ended June 30,
2024.
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v3.24.2.u1
CONVERTIBLE NOTES FINANCINGS
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
CONVERTIBLE NOTES FINANCINGS |
5) CONVERTIBLE NOTES FINANCINGS
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 annum, and the December 2023 convertible notes bear interest at 12% per annum, 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 time-to-time in whole or in part into shares of the Company’s
common stock at an initial conversion rate 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 June 30, 2024, none of the convertible notes were converted into shares of common stock.
The
convertible notes do not contain any ratchet or other financial antidilution provisions. The convertible notes contain conversion limitations
such that no conversion may be made if the aggregate number of shares of common stock beneficially owned by the holder thereof would
exceed 4.99%, 9.99% or 19.99% immediately after conversion thereof, subject to certain increases not in excess of either 9.99% or 19.99%
at the option of such holder.
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 thereof 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 June 30, 2024, there were no events of default that occurred under the convertible
notes.
The
Company determined that there were no embedded derivatives within the convertible notes that required bifurcation from the host agreement.
In connection with the December 2023 convertible notes that were issued on January 11, 2024, the Company allocated the gross proceeds
received and the fees incurred over the applicable convertible notes and warrants based on their relative fair values as follows (in
thousands):
SCHEDULE OF BASED ON RELATIVE FAIR VALUE ALLOCATION OF PROCEEDS AND COSTS
| |
Relative | | |
Allocation | | |
Allocation of Proceeds and Costs | | |
Allocation of Proceeds, | |
| |
Fair Value | | |
Percentage | | |
Proceeds | | |
Costs | | |
Net | |
Convertible notes | |
$ | 1,750 | | |
| 46.24 | % | |
$ | 650 | | |
$ | (31 | ) | |
$ | 619 | |
Note warrants | |
| 2,035 | | |
| 53.76 | % | |
| 755 | | |
| (35 | ) | |
| 720 | |
| |
$ | 3,785 | | |
| 100.00 | % | |
$ | 1,405 | | |
$ | (66 | ) | |
$ | 1,339 | |
The
Company estimated the fair values of the convertible notes as of January 11, 2024 based off a valuation performed by a third-party specialist
as of December 15, 2023 using a binomial tree model and the following assumptions:
SCHEDULE OF FAIR VALUE ASSUMPTIONS
| |
Stock Price | | |
Credit Spread | | |
Volatility | | |
Risk-Free Rate | |
Convertible notes | |
$ | 1.75 | | |
| 2,000 | | |
| 109 | % | |
| 3.90 | % |
The
fair value of the note warrants, all of which qualified for equity classification, was determined using the Black-Scholes pricing model
as of January 11, 2024 using the following assumptions:
| |
Stock Price | | |
Exercise Price | | |
Expected Life | |
Volatility | | |
Dividend | | |
Risk-Free Rate | |
Warrants | |
$ | 1.75 | | |
$ | 1.43 | | |
5 years | |
| 102 | % | |
| 0.00 | % | |
| 3.90 | % |
The
amount of proceeds allocated to the note warrants resulted in a corresponding reduction in the carrying value of the respective convertible
notes as a debt discount, which is amortized with the debt issuance costs as a component of interest expense based on the effective interest
rate method over the contractual terms of the convertible notes.
The
following table shows the activity that occurred during the six months ended June 30, 2024 for the convertible notes on the accompanying
condensed consolidated balance sheet:
SCHEDULE OF ACTIVITY OF CONVERTIBLE NOTES
| |
Gross convertible notes | | |
Debt discount and debt issuance costs | | |
Convertible notes, net | |
| |
| | |
| | |
| |
Beginning balance as of January 1, 2024 | |
$ | 16,616 | | |
$ | (9,843 | ) | |
$ | 6,773 | |
December 2023 notes issued in January 2024 | |
| 1,405 | | |
| (786 | ) | |
| 619 | |
Paid-in-kind interest added to principal | |
| 584 | | |
| - | | |
| 584 | |
Amortization of debt discount and debt issuance costs | |
| - | | |
| 919 | | |
| 919 | |
Ending balance as of June 30, 2024 | |
$ | 18,605 | | |
$ | (9,710 | ) | |
$ | 8,895 | |
To
date, the Company has elected to pay in-kind the accrued interest payable on the convertible notes and has added the accrued and
unpaid interest to the principal amount of the applicable convertible note. For the three months ended June 30, 2024, the Company
has recognized approximately $0.9
million in interest expense for the convertible notes, which includes $0.5
million for the amortization of the debt discount and debt issuance costs and $0.4
million for accrued and unpaid interest on the convertible notes recorded in accrued expenses in the accompanying condensed
consolidated balance sheet. For the six months ended June 30, 2024, the Company has recognized approximately $1.7
million in interest expense, which includes $0.9
million for the amortization of the debt discount and debt issuance costs, $0.4
million recorded for accrued and unpaid interest on the convertible notes recorded in accrued expenses in the accompanying condensed
consolidated balance sheet and $0.4
million of accrued interest that was paid in-kind and added to the principal of the convertible notes.
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v3.24.2.u1
FAIR VALUE OF FINANCIAL INSTRUMENTS
|
6 Months Ended |
Jun. 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 and cash equivalents, 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. Both of these liabilities
are remeasured at each reporting period, with changes in their fair values recognized in earnings.
The
Company uses a Black-Scholes option pricing model to estimate the fair value of its 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 remeasures the fair value of the warrant liabilities 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 June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE
Description | |
Level | | |
June 30, 2024 | | |
December 31, 2023 | |
Liabilities: | |
| | | |
| | | |
| | |
Warrant liabilities - Q1-22 warrants | |
| 3 | | |
$ | 50 | | |
$ | 116 | |
Market Cap Contingent Consideration | |
| 3 | | |
$ | 41 | | |
$ | 107 | |
Liabilities, fair value disclosure | |
| 3 | | |
$ | 41 | | |
$ | 107 | |
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 June 30, 2024 (in thousands):
SCHEDULE OF CHANGES IN WARRANT LIABILITIES
| |
Warrant Liabilities | | |
Contingent Consideration | |
| |
| | |
| |
Fair value at January 1, 2024 | |
$ | 116 | | |
$ | 107 | |
Change in fair value | |
| (66 | ) | |
| (66 | ) |
Fair value at June 30, 2024 | |
$ | 50 | | |
$ | 41 | |
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 June 30, 2024 and December 31, 2023
(in thousands).
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES
| |
| | |
June 30, 2024 | | |
December 31, 2023 | |
| |
Level | | |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
Convertible notes | |
| 3 | | |
$ | 18,605 | | |
$ | 22,470 | | |
$ | 16,616 | | |
$ | 17,594 | |
The
carrying value in the table above is shown before the allocation of the proceeds to the note warrants. The Company assesses the fair
value of the convertible notes as of June 30, 2024 using a Monte Carlo simulation model and as of December 31, 2023 using a binomial
model, both of which are considered a Level 3 measurement.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.2.u1
GOODWILL
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
GOODWILL |
7) 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 June 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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- DefinitionThe entire disclosure for goodwill and intangible assets.
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v3.24.2.u1
LEASES
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
LEASES |
8) LEASES
The
Company currently has operating leases for office and laboratory space 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 provides 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.
The
Sublessor provided the Company with a tenant improvement allowance (“TIA”) of $per rentable square foot, or $8.6
million. As of June 30, 2024, the Company received
the entire $8.6
million TIA. The Company incurred out-of-pocket tenant improvements costs of approximately $1.6 million, which were in excess
of the $8.6 million TIA.
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. See Note 17 for more information on the sublease termination agreement.
For
the three and six months ended June 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 June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease expense | |
$ | 1,633 | | |
$ | 67 | | |
$ | 3,269 | | |
$ | 135 | |
Sublease income | |
| (21 | ) | |
| (21 | ) | |
| (42 | ) | |
| (42 | ) |
Variable lease expense | |
| 332 | | |
| 7 | | |
| 663 | | |
| 12 | |
Total lease expense | |
$ | 1,944 | | |
$ | 53 | | |
$ | 3,890 | | |
$ | 105 | |
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 June 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 | |
Amortization of operating lease ROU assets | |
| (1,036 | ) |
Operating lease ROU assets at June 30, 2024 | |
$ | 35,990 | |
| |
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 | |
| 1,787 | |
Principal payments on operating lease liabilities | |
| (792 | ) |
Operating lease liabilities at June 30, 2024 | |
| 40,310 | |
Less non-current portion | |
| 36,044 | |
Current portion at June 30, 2024 | |
$ | 4,266 | |
As
of June 30, 2024, the Company’s operating leases had a weighted-average remaining life of 9.3 years with a weighted-average discount
rate of 11.07%. The maturities of the operating lease liabilities are as follows (in thousands):
MATURITIES
OF OPERATING LEASE LIABILITIES
| |
As of June 30, 2024 | |
2024 | |
$ | 5,305 | |
2025 | |
| 6,075 | |
2026 | |
| 6,238 | |
2027 | |
| 6,308 | |
2028 | |
| 6,406 | |
Thereafter | |
| 33,879 | |
Total payments | |
| 64,211 | |
Less imputed interest | |
| (23,901 | ) |
Total operating lease liabilities | |
$ | 40,310 | |
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v3.24.2.u1
ACCRUED EXPENSES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
9) ACCRUED EXPENSES
Accrued
expenses at June 30, 2024 and December 31, 2023 consisted of the following (in thousands):
SCHEDULE
OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
Somerville facility | |
$ | 547 | | |
$ | 218 | |
Legal fees | |
| 545 | | |
| 643 | |
Convertible notes interest | |
| 422 | | |
| 176 | |
Professional fees | |
| 229 | | |
| 239 | |
Accrued compensation | |
| 134 | | |
| 109 | |
Other | |
| 512 | | |
| 508 | |
Total accrued expenses | |
$ | 2,389 | | |
$ | 1,893 | |
|
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- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
RELATED PARTY TRANSACTIONS
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
10) RELATED PARTY TRANSACTIONS
Agreements
with Factor Bioscience Inc. and Affiliates
As
of June 30, 2024, the Company had 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 will be 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 by and among Eterna LLC, Novellus Limited and Factor Limited (the “Original Factor License Agreement”). Under the terms
of 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 June 30, 2024, there was approximately $0.3 million of the unamortized License
Fee Obligation remaining, which is recorded on the accompanying condensed consolidated balance sheet in the “due to related party,
current” line item.
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 terms of 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 term of the A&R Factor License Agreement expires on
November 22, 2027, but will be automatically extended for an additional five years (such period, the “Renewal Term”) if the
Company pays at least $6.0 million to Factor Limited from fees from sublicenses to the Factor Patents (“Sublicense Fees”),
other cash on hand or a combination of both sources of funds. The Company will pay to Factor Limited 20% of any Sublicense Fee received
by the Company during the term of the A&R Factor License Agreement. Beginning in September 2024, the Company will also begin paying
Factor Limited a monthly maintenance fee of approximately $0.4 million until the expiration of the A&R Factor License Agreement,
including any Renewal Term. The Company may terminate the A&R Factor License Agreement upon 120 days’ written notice to Factor
Limited, and both parties have additional customary termination rights. Under the A&R Factor License Agreement, the Company is obligated
to pay the expenses incurred by Factor Limited in preparing, filing, prosecuting and maintaining the Factor Patents and the Company agreed
to bear all costs and expenses associated with enforcing and defending the Factor Patents in any action or proceeding arising from pursuit
of sublicensing opportunities under the license granted under the A&R Factor License Agreement.
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 and December 2023 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 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 4 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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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Jun. 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.
A status conference has been set for September 12, 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.
Licensing
Agreements
On
November 14, 2023, the Company entered into the A&R Factor License Agreement with Factor Limited. See Note 9 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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v3.24.2.u1
STOCK-BASED COMPENSATION
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
12) STOCK-BASED COMPENSATION
Stock
Options
During
the three and six months ended June 30, 2024 and 2023, the Company granted stock 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Stock options granted | |
| 501 | | |
| 25 | | |
| 2,375 | | |
| 237 | |
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 stock 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 now 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 three and six months ended June 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 three and six months ended June 30, 2024 and 2023:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS USED FOR STOCK OPTIONS GRANTED
ixbrl | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted average risk-free rate | |
| 4.32 | % | |
| 3.54 | % | |
| 4.45 | % | |
| 3.82 | % |
Weighted average volatility | |
| 91.77 | % | |
| 96.09 | % | |
| 97.91 | % | |
| 95.15 | % |
Dividend yield | |
| 0.00 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected term | |
| 5.68 years | | |
| 6.08 years | | |
| 5.85 years | | |
| 5.44 years | |
The
per-share weighted average grant-date fair value of stock options granted during the three and six months ended June 30, 2024 and
2023 were as follows:
SCHEDULE
OF WEIGHTED AVERAGE GRANT-DATE FAIR VALUE OF STOCK OPTIONS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted average grant date fair value | |
$ | 1.42 | | |
$ | 1.64 | | |
$ | 1.44 | | |
$ | 2.99 | |
Vesting
of all stock options is subject to continuous service with the Company through the applicable vesting date. As of June 30, 2024,
there were approximately 2,536,000 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 six months ended June 30, 2024 and 2023, less than 1,000 RSUs vested. As of June 30,
2024, there were less than 1,000 RSUs outstanding.
The
Company did not grant RSUs during either of the three or six months ended June 30, 2024 and 2023.
Stock-Based
Compensation Expense
For
the three and six months ended June 30, 2024 and 2023, the Company recognized stock-based compensation expense as follows (in thousands):
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 15 | | |
$ | 56 | | |
$ | 61 | | |
$ | 120 | |
General and administrative | |
| 408 | | |
| 158 | | |
| 644 | | |
| 783 | |
Total | |
$ | 423 | | |
$ | 214 | | |
$ | 705 | | |
$ | 903 | |
|
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v3.24.2.u1
WARRANTS
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
WARRANTS |
13) 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 warrants outstanding
from a private placement completed in the fourth quarter of 2022 (the “Q4-22 warrants”).
As
of June 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 |
Q4-22 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 June 30, 2024, the weighted average remaining contractual life of the warrants outstanding was 4.21 years and the weighted average
exercise price was $2.05.
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v3.24.2.u1
NET LOSS PER SHARE
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
NET LOSS PER SHARE |
14) 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 six months
ended June 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 six months ended June 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 20,386 | | |
| 4,713 | |
Convertible Notes converted into common stock | |
| 8,135 | | |
| - | |
Stock options | |
| 2,536 | | |
| 522 | |
Preferred stock converted into common stock | |
| 19 | | |
| 7 | |
RSUs | |
| - | | |
| 1 | |
Total potential common shares excluded from computation | |
| 31,076 | | |
| 5,243 | |
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v3.24.2.u1
STANDBY EQUITY PURCHASE AGREEMENT
|
6 Months Ended |
Jun. 30, 2024 |
Standby Equity Purchase Agreement |
|
STANDBY EQUITY PURCHASE AGREEMENT |
15) STANDBY EQUITY PURCHASE AGREEMENT
On
April 5, 2023, the Company entered into the SEPA 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, 2025, which was the date on which
each of the conditions to the 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 six months ended June 30, 2023.
In
April 2023, the Company filed a registration statement on Form S-1 (File No. 333-271279) 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 “SEPA S-1”).
During
the three and six months ended June 30, 2023, the Company issued and sold approximately 214,000
shares of common stock under the SEPA, including the approximately 74,000
commitment shares, for gross proceeds of $0.3
million. No
shares have been sold under the SEPA during the three or six months ended June 30, 2024. As of June 30, 2024, there were
approximately 2,716,000
shares remaining to be sold under the SEPA that are registered for resale by Lincoln Park under the SEPA S-1.
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SUBSEQUENT EVENT
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENT |
17) SUBSEQUENT EVENT
On August 5, 2024, the sublessor
of the Company’s sublease for the property located in Somerville, Massachusetts drew down on the letter of credit related to the
sublease 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 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, the Company agreed to surrender and vacate the premises, all of 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 both parties will be released of their obligations under the sublease. As a result of the sublease termination, the Company expects to save approximately $58.5 million in base rental payments
plus parking, operating expenses, taxes and utilities that it would have paid over the remaining lease term.
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- DefinitionTabular disclosure of asset acquisition.
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v3.24.2.u1
CONVERTIBLE NOTES FINANCINGS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
SCHEDULE OF BASED ON RELATIVE FAIR VALUE ALLOCATION OF PROCEEDS AND COSTS |
The
Company determined that there were no embedded derivatives within the convertible notes that required bifurcation from the host agreement.
In connection with the December 2023 convertible notes that were issued on January 11, 2024, the Company allocated the gross proceeds
received and the fees incurred over the applicable convertible notes and warrants based on their relative fair values as follows (in
thousands):
SCHEDULE OF BASED ON RELATIVE FAIR VALUE ALLOCATION OF PROCEEDS AND COSTS
| |
Relative | | |
Allocation | | |
Allocation of Proceeds and Costs | | |
Allocation of Proceeds, | |
| |
Fair Value | | |
Percentage | | |
Proceeds | | |
Costs | | |
Net | |
Convertible notes | |
$ | 1,750 | | |
| 46.24 | % | |
$ | 650 | | |
$ | (31 | ) | |
$ | 619 | |
Note warrants | |
| 2,035 | | |
| 53.76 | % | |
| 755 | | |
| (35 | ) | |
| 720 | |
| |
$ | 3,785 | | |
| 100.00 | % | |
$ | 1,405 | | |
$ | (66 | ) | |
$ | 1,339 | |
|
SCHEDULE OF FAIR VALUE ASSUMPTIONS |
The
Company estimated the fair values of the convertible notes as of January 11, 2024 based off a valuation performed by a third-party specialist
as of December 15, 2023 using a binomial tree model and the following assumptions:
SCHEDULE OF FAIR VALUE ASSUMPTIONS
| |
Stock Price | | |
Credit Spread | | |
Volatility | | |
Risk-Free Rate | |
Convertible notes | |
$ | 1.75 | | |
| 2,000 | | |
| 109 | % | |
| 3.90 | % |
The
fair value of the note warrants, all of which qualified for equity classification, was determined using the Black-Scholes pricing model
as of January 11, 2024 using the following assumptions:
| |
Stock Price | | |
Exercise Price | | |
Expected Life | |
Volatility | | |
Dividend | | |
Risk-Free Rate | |
Warrants | |
$ | 1.75 | | |
$ | 1.43 | | |
5 years | |
| 102 | % | |
| 0.00 | % | |
| 3.90 | % |
|
SCHEDULE OF ACTIVITY OF CONVERTIBLE NOTES |
The
following table shows the activity that occurred during the six months ended June 30, 2024 for the convertible notes on the accompanying
condensed consolidated balance sheet:
SCHEDULE OF ACTIVITY OF CONVERTIBLE NOTES
| |
Gross convertible notes | | |
Debt discount and debt issuance costs | | |
Convertible notes, net | |
| |
| | |
| | |
| |
Beginning balance as of January 1, 2024 | |
$ | 16,616 | | |
$ | (9,843 | ) | |
$ | 6,773 | |
December 2023 notes issued in January 2024 | |
| 1,405 | | |
| (786 | ) | |
| 619 | |
Paid-in-kind interest added to principal | |
| 584 | | |
| - | | |
| 584 | |
Amortization of debt discount and debt issuance costs | |
| - | | |
| 919 | | |
| 919 | |
Ending balance as of June 30, 2024 | |
$ | 18,605 | | |
$ | (9,710 | ) | |
$ | 8,895 | |
|
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v3.24.2.u1
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables)
|
6 Months Ended |
Jun. 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 June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE
Description | |
Level | | |
June 30, 2024 | | |
December 31, 2023 | |
Liabilities: | |
| | | |
| | | |
| | |
Warrant liabilities - Q1-22 warrants | |
| 3 | | |
$ | 50 | | |
$ | 116 | |
Market Cap Contingent Consideration | |
| 3 | | |
$ | 41 | | |
$ | 107 | |
Liabilities, fair value disclosure | |
| 3 | | |
$ | 41 | | |
$ | 107 | |
|
SCHEDULE OF CHANGES IN WARRANT LIABILITIES |
The
following table presents the changes in the liabilities measured at fair value from January 1, 2024 through June 30, 2024 (in thousands):
SCHEDULE OF CHANGES IN WARRANT LIABILITIES
| |
Warrant Liabilities | | |
Contingent Consideration | |
| |
| | |
| |
Fair value at January 1, 2024 | |
$ | 116 | | |
$ | 107 | |
Change in fair value | |
| (66 | ) | |
| (66 | ) |
Fair value at June 30, 2024 | |
$ | 50 | | |
$ | 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 June 30, 2024 and December 31, 2023
(in thousands).
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES
| |
| | |
June 30, 2024 | | |
December 31, 2023 | |
| |
Level | | |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
Convertible notes | |
| 3 | | |
$ | 18,605 | | |
$ | 22,470 | | |
$ | 16,616 | | |
$ | 17,594 | |
|
X |
- DefinitionTabular disclosure of financial instrument measured at fair value on recurring or nonrecurring basis. Includes, but is not limited to, instrument classified in shareholders' equity.
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v3.24.2.u1
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
NET OPERATING LEASE EXPENSE |
For
the three and six months ended June 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 June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating lease expense | |
$ | 1,633 | | |
$ | 67 | | |
$ | 3,269 | | |
$ | 135 | |
Sublease income | |
| (21 | ) | |
| (21 | ) | |
| (42 | ) | |
| (42 | ) |
Variable lease expense | |
| 332 | | |
| 7 | | |
| 663 | | |
| 12 | |
Total lease expense | |
$ | 1,944 | | |
$ | 53 | | |
$ | 3,890 | | |
$ | 105 | |
|
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 June 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 | |
Amortization of operating lease ROU assets | |
| (1,036 | ) |
Operating lease ROU assets at June 30, 2024 | |
$ | 35,990 | |
| |
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 | |
| 1,787 | |
Principal payments on operating lease liabilities | |
| (792 | ) |
Operating lease liabilities at June 30, 2024 | |
| 40,310 | |
Less non-current portion | |
| 36,044 | |
Current portion at June 30, 2024 | |
$ | 4,266 | |
|
MATURITIES OF OPERATING LEASE LIABILITIES |
MATURITIES
OF OPERATING LEASE LIABILITIES
| |
As of June 30, 2024 | |
2024 | |
$ | 5,305 | |
2025 | |
| 6,075 | |
2026 | |
| 6,238 | |
2027 | |
| 6,308 | |
2028 | |
| 6,406 | |
Thereafter | |
| 33,879 | |
Total payments | |
| 64,211 | |
Less imputed interest | |
| (23,901 | ) |
Total operating lease liabilities | |
$ | 40,310 | |
|
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v3.24.2.u1
ACCRUED EXPENSES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES |
Accrued
expenses at June 30, 2024 and December 31, 2023 consisted of the following (in thousands):
SCHEDULE
OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
Somerville facility | |
$ | 547 | | |
$ | 218 | |
Legal fees | |
| 545 | | |
| 643 | |
Convertible notes interest | |
| 422 | | |
| 176 | |
Professional fees | |
| 229 | | |
| 239 | |
Accrued compensation | |
| 134 | | |
| 109 | |
Other | |
| 512 | | |
| 508 | |
Total accrued expenses | |
$ | 2,389 | | |
$ | 1,893 | |
|
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v3.24.2.u1
STOCK-BASED COMPENSATION (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
SCHEDULE OF STOCK OPTION GRANTED |
During
the three and six months ended June 30, 2024 and 2023, the Company granted stock 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Stock options granted | |
| 501 | | |
| 25 | | |
| 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 three and six months ended June 30, 2024 and 2023:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS USED FOR STOCK OPTIONS GRANTED
ixbrl | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted average risk-free rate | |
| 4.32 | % | |
| 3.54 | % | |
| 4.45 | % | |
| 3.82 | % |
Weighted average volatility | |
| 91.77 | % | |
| 96.09 | % | |
| 97.91 | % | |
| 95.15 | % |
Dividend yield | |
| 0.00 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected term | |
| 5.68 years | | |
| 6.08 years | | |
| 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 three and six months ended June 30, 2024 and
2023 were as follows:
SCHEDULE
OF WEIGHTED AVERAGE GRANT-DATE FAIR VALUE OF STOCK OPTIONS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted average grant date fair value | |
$ | 1.42 | | |
$ | 1.64 | | |
$ | 1.44 | | |
$ | 2.99 | |
|
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE |
For
the three and six months ended June 30, 2024 and 2023, the Company recognized stock-based compensation expense as follows (in thousands):
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 15 | | |
$ | 56 | | |
$ | 61 | | |
$ | 120 | |
General and administrative | |
| 408 | | |
| 158 | | |
| 644 | | |
| 783 | |
Total | |
$ | 423 | | |
$ | 214 | | |
$ | 705 | | |
$ | 903 | |
|
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v3.24.2.u1
WARRANTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF WARRANTS OUTSTANDING |
As
of June 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 |
Q4-22 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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v3.24.2.u1
NET LOSS PER SHARE (Tables)
|
6 Months Ended |
Jun. 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 six months
ended June 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 six months ended June 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 20,386 | | |
| 4,713 | |
Convertible Notes converted into common stock | |
| 8,135 | | |
| - | |
Stock options | |
| 2,536 | | |
| 522 | |
Preferred stock converted into common stock | |
| 19 | | |
| 7 | |
RSUs | |
| - | | |
| 1 | |
Total potential common shares excluded from computation | |
| 31,076 | | |
| 5,243 | |
|
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v3.24.2.u1
LIQUIDITY AND CAPITAL RESOURCES (Details Narrative) $ in Thousands |
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
|
Jan. 11, 2024
USD ($)
|
Jan. 31, 2024
USD ($)
|
Jun. 30, 2024
USD ($)
shares
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
shares
|
Dec. 31, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
shares
|
Aug. 05, 2024
USD ($)
|
Apr. 30, 2023
USD ($)
|
Oct. 31, 2022
USD ($)
ft²
|
Cash |
|
|
$ 2,586
|
|
$ 2,586
|
$ 7,575
|
|
$ 7,575
|
|
|
|
Accumulated deficit |
|
|
199,165
|
|
199,165
|
186,981
|
|
$ 186,981
|
|
|
|
Net loss |
|
|
$ 5,529
|
$ 4,508
|
12,176
|
|
$ 9,924
|
|
|
|
|
Net cash used in operating activities |
|
|
|
|
6,006
|
|
9,921
|
|
|
|
|
Area of premises | ft² |
|
|
|
|
|
|
|
|
|
|
45,500
|
Letter of credit |
|
|
|
|
|
|
|
|
|
|
$ 4,100
|
Restricted cash |
|
|
|
|
|
|
|
|
|
|
$ 4,100
|
Proceeds received from the convertible notes financing |
$ 1,405
|
|
|
|
$ 1,405
|
|
|
|
|
|
|
Convertible Debt [Member] |
|
|
|
|
|
|
|
|
|
|
|
Proceeds received from the convertible notes financing |
|
$ 1,400
|
|
|
|
$ 16,500
|
|
|
|
|
|
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
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
Letter of credit |
|
|
|
|
|
|
|
|
$ 4,100
|
|
|
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ASSET ACQUISITION (Details Narrative) $ in Thousands |
Apr. 26, 2023
USD ($)
shares
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Allocated percentage of fair value of consideration to purchased license |
100.00%
|
Exacis Asset Purchase Agreement [Member] |
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Asset acquisition of common stock | shares |
69,000
|
Lock-up period |
12 months
|
Estimated equity value of stock issued in asset acquisition |
$ 75,000
|
Asset acquisition, share price | shares |
3.00
|
Cash or other consideration |
$ (208)
|
Exacis Asset Purchase Agreement [Member] | Maximum [Member] |
|
Business Acquisition, Contingent Consideration [Line Items] |
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Cash or other consideration |
$ 45,000
|
Exacis Asset Purchase Agreement [Member] | Contingent Consideration One [Member] |
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Common stock purchase period |
3 years
|
Minimum market capitalization requirement, amount |
$ 100,000
|
Number of consecutive trading days |
10 days
|
Numerator value for stock issuance |
$ 2,000
|
Exacis Asset Purchase Agreement [Member] | Contingent Consideration Two [Member] |
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Common stock purchase period |
3 years
|
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$ 200,000
|
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10 days
|
Numerator value for stock issuance |
$ 2,000
|
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5 years
|
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20.00%
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v3.24.2.u1
CONTRACT WITH CUSTOMER (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
Aug. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
Proceeds from option and license agreement |
$ 300,000
|
|
|
$ 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 |
|
|
$ 0
|
|
$ 0
|
Option fee obligation payment percentage |
|
|
|
20.00%
|
|
License fees |
|
|
$ 0
|
|
|
Maximum [Member] |
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
Revenue recognized |
|
$ 100,000
|
|
$ 100,000
|
|
License fees |
|
|
|
|
$ 100,000
|
Transferred over Time [Member] |
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
Revenue recognized |
|
|
|
$ 400,000
|
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|
Jun. 30, 2024 |
Jan. 11, 2024
Integer
|
Warrant [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Expected life |
4 years 2 months 15 days
|
|
Measurement Input, Share Price [Member] | Warrant [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Warrants , measurement input |
|
1.75
|
Measurement Input, Price Volatility [Member] | Warrant [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible note, measurement input |
|
102
|
Measurement Input, Risk Free Interest Rate [Member] | Warrant [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible note, measurement input |
|
3.90
|
Measurement Input, Exercise Price [Member] | Warrant [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Warrants , measurement input |
|
1.43
|
Measurement Input, Expected Term [Member] | Warrant [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Expected life |
|
5 years
|
Measurement Input, Expected Dividend Rate [Member] | Warrant [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible note, measurement input |
|
0.00
|
Convertible Debt [Member] | Measurement Input, Share Price [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible note, measurement input |
|
1.75
|
Convertible Debt [Member] | Measurement Input, Credit Spread [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible note, measurement input |
|
2,000,000
|
Convertible Debt [Member] | Measurement Input, Price Volatility [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible note, measurement input |
|
109
|
Convertible Debt [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Convertible note, measurement input |
|
3.90
|
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v3.24.2.u1
SCHEDULE OF ACTIVITY OF CONVERTIBLE NOTES (Details) - USD ($) $ in Thousands |
|
3 Months Ended |
6 Months Ended |
Jan. 11, 2024 |
Jun. 30, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
Convertible notes, net beginning balance |
|
|
$ 6,773
|
|
Gross convertible notes at issuance |
$ 1,405
|
|
1,405
|
|
Payments of debt issuance costs |
(66)
|
|
|
|
Paid-in-kind interest added to principal |
|
|
584
|
|
Amortization of the debt discount and debt issuance costs |
|
|
919
|
|
Convertible notes, net ending balance |
|
$ 8,895
|
8,895
|
|
Convertible Debt [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Gross convertible notes, beginning balance |
|
|
16,616
|
|
Debt discount and debt issuance costs beginning balance |
|
|
(9,843)
|
|
Convertible notes, net beginning balance |
|
|
6,773
|
|
Gross convertible notes at issuance |
650
|
|
|
|
Payments of debt issuance costs |
$ (31)
|
|
|
|
Paid-in-kind interest added to principal |
|
|
584
|
|
Paid-in-kind interest added to principal net |
|
|
584
|
|
Amortization of the debt discount and debt issuance costs |
|
500
|
919
|
|
Amortization of the debt discount and debt issuance costs net |
|
|
919
|
|
Gross convertible notes ending balance |
|
18,605
|
18,605
|
|
Debt discount and debt issuance costs ending balance |
|
(9,710)
|
(9,710)
|
|
Convertible notes, net ending balance |
|
$ 8,895
|
8,895
|
|
December 2023 Convertible Notes [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Gross convertible notes at issuance |
|
|
1,405
|
|
Payments of debt issuance costs |
|
|
(786)
|
|
Net convertible notes at issuance |
|
|
$ 619
|
|
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v3.24.2.u1
CONVERTIBLE NOTES FINANCINGS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
|
|
Jul. 14, 2023 |
Jul. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jan. 11, 2024 |
Dec. 31, 2023 |
Dec. 15, 2023 |
Dec. 14, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
$ 8,895
|
$ 8,895
|
|
|
$ 6,773
|
|
|
Interest expense |
|
|
|
422
|
|
|
|
|
|
Amortization of debt discount and debt issuance costs |
|
|
|
919
|
|
|
|
|
|
Accrued expenses |
|
|
2,389
|
2,389
|
|
|
1,893
|
|
|
Unpaid interest on convertible notes |
|
|
|
400
|
|
|
|
|
|
Convertible Debt [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
8,895
|
$ 8,895
|
|
|
$ 6,773
|
|
|
Debt, maturity period |
|
5 years
|
|
|
|
|
|
|
|
Repurchase price percentage |
|
|
|
100.00%
|
|
|
|
|
|
Interest expense |
|
|
900
|
$ 1,700
|
|
|
|
|
|
Amortization of debt discount and debt issuance costs |
|
|
500
|
919
|
|
|
|
|
|
Accrued expenses |
|
|
$ 400
|
$ 400
|
|
|
|
|
|
Convertible Debt [Member] | Debt Instrument, Redemption, Period One [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Beneficial conversion feature percentage |
|
4.99%
|
|
|
|
|
|
|
|
Convertible Debt [Member] | Debt Instrument, Redemption, Period One [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Beneficial conversion feature percentage |
|
9.99%
|
|
|
|
|
|
|
|
Convertible Debt [Member] | Debt Instrument, Redemption, Period Two [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Beneficial conversion feature percentage |
9.99%
|
|
|
|
|
|
|
|
|
Convertible Debt [Member] | Debt Instrument, Redemption, Period Two [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Beneficial conversion feature percentage |
|
19.99%
|
|
|
|
|
|
|
|
Convertible Debt [Member] | Debt Instrument, Redemption, Period Three [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Beneficial conversion feature percentage |
|
19.99%
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Number of convertible notes converted into shares |
|
|
|
0
|
|
|
|
|
|
July 2023 Note Warrants [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
6,100,000
|
|
|
|
|
|
|
|
|
July 2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Convertible notes |
$ 8,700
|
|
|
|
|
|
|
|
|
Aggregate principal amount |
8,700
|
|
|
|
|
|
|
|
|
Transaction fees |
$ 200
|
|
|
|
|
|
|
|
|
Interest rate |
|
6.00%
|
|
|
|
|
|
|
|
Initial conversion rate |
|
$ 2.86
|
|
|
|
|
|
|
|
December 2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Convertible notes |
|
|
|
|
|
$ 1,400
|
|
$ 7,800
|
|
Aggregate principal amount |
|
|
|
|
|
$ 1,400
|
|
$ 7,800
|
$ 9,200
|
Warrants to purchase common shares |
|
|
|
|
|
|
|
|
9,600,000
|
Interest rate |
|
|
|
|
|
|
12.00%
|
|
|
Initial conversion rate |
|
|
|
|
|
|
$ 1.9194
|
|
|
December 2023 Convertible Notes [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
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SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Market Cap Contingent Consideration [Member] |
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
|
Liabilities, fair value disclosure |
$ 41
|
$ 107
|
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|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
|
Liabilities, fair value disclosure |
$ 50
|
$ 116
|
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- DefinitionFair value of financial and nonfinancial obligations.
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v3.24.2.u1
SCHEDULE OF CHANGES IN WARRANT LIABILITIES (Details) $ in Thousands |
6 Months Ended |
Jun. 30, 2024
USD ($)
|
Contingent Consideration [Member] |
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
|
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$ 107
|
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(66)
|
Fair value at June 30, 2024 |
41
|
Derivative Financial Instruments, Liabilities [Member] |
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] |
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116
|
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|
Fair value at June 30, 2024 |
$ 50
|
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v3.24.2.u1
SCHEDULE OF FAIR VALUE AND CARRYING VALUES OF CONVERTIBLE NOTES (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Jan. 11, 2024 |
Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Convertible debt |
|
$ 3,785
|
|
Fair Value, Inputs, Level 3 [Member] | Reported Value Measurement [Member] |
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Convertible debt |
$ 18,605
|
|
$ 16,616
|
Fair Value, Inputs, Level 3 [Member] | Estimate of Fair Value Measurement [Member] |
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
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$ 22,470
|
|
$ 17,594
|
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v3.24.2.u1
OPERATING LEASE RIGHT-OF-USE ASSETS AND LIABILITIES (Details) - USD ($) $ in Thousands |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Leases |
|
|
|
Operating lease ROU assets, Beginning |
$ 32,781
|
|
|
Adjustment to ROU asset for remeasurement of Somerville Sublease liability |
4,245
|
|
|
Amortization of operating lease ROU assets |
(1,036)
|
$ (83)
|
|
Operating lease ROU assets, Ending |
35,990
|
|
|
Operating lease liabilities, Beginning |
35,070
|
|
|
Adjustment to lease liablity due to remeasurement of Somerville Sublease |
4,245
|
|
|
Accretion of interest for Somerville Sublease |
1,787
|
|
|
Principal payments on operating lease liabilities |
(792)
|
|
|
Operating lease liabilities, Ending |
40,310
|
|
|
Less non-current portion |
36,044
|
|
$ 32,854
|
Current portion |
$ 4,266
|
|
$ 2,216
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MATURITIES OF OPERATING LEASE LIABILITIES (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Leases |
|
|
2024 |
$ 5,305
|
|
2025 |
6,075
|
|
2026 |
6,238
|
|
2027 |
6,308
|
|
2028 |
6,406
|
|
Thereafter |
33,879
|
|
Total payments |
64,211
|
|
Less imputed interest |
(23,901)
|
|
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$ 40,310
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$ 35,070
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v3.24.2.u1
LEASES (Details Narrative)
|
|
1 Months Ended |
|
|
|
May 03, 2024
USD ($)
|
Oct. 31, 2022
USD ($)
ft²
|
Aug. 31, 2024
USD ($)
|
Aug. 05, 2024
USD ($)
|
Jun. 30, 2024
USD ($)
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
Area of Real Estate Property | ft² |
|
45,500
|
|
|
|
Letter of credit |
|
$ 4,100,000
|
|
|
|
Past due rent amount |
$ 2,300,000
|
|
|
|
|
Late fees and interest payment due on rent amount |
$ 70,000
|
|
|
|
|
Weighted average remaining lease term |
|
|
|
|
9 years 3 months 18 days
|
Weighted average discount rate |
|
|
|
|
11.07%
|
Subsequent Event [Member] |
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
Letter of credit |
|
|
|
$ 4,100,000
|
|
Rental payments |
|
|
$ 4,000,000.0
|
$ 4,000,000.0
|
|
ER Squibb Sons LLC [Member] |
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
Area of Real Estate Property | ft² |
|
45,500
|
|
|
|
[custom:OperatingLeasesMonthlyBaseRent] |
|
$ 500,000
|
|
|
|
Letter of credit |
|
4,100,000
|
|
|
|
[custom:TenantImprovementAllowancePerRentableSquareFoot-0] |
|
190
|
|
|
|
[custom:TenantImprovementAllowance-0] |
|
8,600,000
|
|
|
|
Received amount of tenant improvement allowance |
|
8,600,000
|
|
|
$ 8,600,000
|
Cost improvement |
|
$ 1,600,000
|
|
|
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v3.24.2.u1
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Feb. 20, 2023 |
May 31, 2023 |
Sep. 30, 2022 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Nov. 30, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Monthly installment fees amount |
$ 400,000
|
|
|
|
|
|
|
|
Research and development expense |
|
|
|
$ 987,000
|
$ 1,499,000
|
$ 2,445,000
|
$ 3,173,000
|
|
License agreement automatic renewal term |
|
|
|
|
|
5 years
|
|
|
Percentage of sublicense fees paid before license expiration date |
20.00%
|
|
|
|
|
|
|
|
Notice period for first termination of contract |
|
|
|
|
|
120 days
|
|
|
Director [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Monthly installment fees amount |
|
$ 20,000
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
Sublicense fees |
$ 6,000,000.0
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
Remaining unamortized license fee obligation |
|
|
|
$ 300,000
|
|
$ 300,000
|
|
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SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
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$ 214
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$ 705
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$ 903
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56
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61
|
120
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|
|
|
|
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|
|
|
|
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$ 408
|
$ 158
|
$ 644
|
$ 783
|
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STOCK-BASED COMPENSATION (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
3 Months Ended |
6 Months Ended |
Apr. 26, 2024 |
Jan. 01, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
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Stock-based compensation expense |
|
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$ 423
|
$ 214
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$ 705
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$ 903
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Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Stock options granted |
|
|
501,000
|
25,000
|
2,375,000
|
237,000
|
Number of stock option awards outstanding |
|
|
2,536,000
|
|
2,536,000
|
|
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
|
|
$ 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 period |
2 years
|
|
|
|
|
|
Vesting percentage |
75.00%
|
|
|
|
|
|
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|
|
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Number of RSUs granted |
|
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0
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0
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0
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0
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v3.24.2.u1
SCHEDULE OF WARRANTS OUTSTANDING (Details) shares in Thousands |
6 Months Ended |
Jun. 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
|
Q4-22 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 |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
31,076
|
5,243
|
31,076
|
5,243
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
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20,386
|
4,713
|
20,386
|
4,713
|
Convertible Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
8,135
|
|
8,135
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
2,536
|
522
|
2,536
|
522
|
Convertible Preferred Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential common shares excluded from computation |
19
|
7
|
19
|
7
|
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|
|
|
|
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|
|
|
|
Total potential common shares excluded from computation |
|
1
|
|
1
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v3.24.2.u1
STANDBY EQUITY PURCHASE AGREEMENT (Details Narrative) - USD ($) $ in Millions |
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Apr. 05, 2023 |
Apr. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Common Stock [Member] |
|
|
|
|
|
|
Shares issued for purchase agreement |
|
|
|
69,000
|
|
69,000
|
Number of shares issued |
|
|
|
214,000
|
|
214,000
|
Lincoln Park [Member] | SEPA [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] | SEPA [Member] | Commitment Shares [Member] |
|
|
|
|
|
|
Shares issued for purchase agreement |
74,000
|
74,000
|
|
74,000
|
|
74,000
|
Lincoln Park [Member] | SEPA [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] | SEPA [Member] |
|
|
|
|
|
|
Aggregate gross purchase price |
$ 10.0
|
|
|
|
|
|
Common stock purchase agreement commencement period |
24 months
|
|
|
|
|
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Eterna Therapeutics (NASDAQ:ERNA)
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