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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2023
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 No. 001-38207
CELCUITY
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
No.
82-2863566 |
(State
of incorporation) |
|
(IRS
Employer Identification No.) |
16305
36th Avenue North; Suite 100
Minneapolis,
Minnesota 55446
(Address
of principal executive offices, including zip code)
Registrant’s
telephone number, including area code: (763) 392-0767
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.001 par value per share |
|
CELC |
|
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 the 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
☒
On
November 6, 2023 there were 24,203,156 shares of the registrant’s common stock, $0.001 par value per share, outstanding.
Celcuity
Inc.
Table
of Contents
As
used in this report, the terms “we,” “us,” “our,” “Celcuity,” and the “Company”
mean Celcuity Inc., unless the context indicates another meaning.
PART
I. FINANCIAL INFORMATION
ITEM
1. Financial Statements
Celcuity
Inc.
Condensed
Balance Sheets
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| (unaudited) | | |
| | |
Assets | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 25,759,887 | | |
$ | 24,571,557 | |
Investments | |
| 108,180,417 | | |
| 144,015,954 | |
Other current assets | |
| 7,771,131 | | |
| 6,603,026 | |
Total current assets | |
| 141,711,435 | | |
| 175,190,537 | |
Property and equipment, net | |
| 223,378 | | |
| 260,294 | |
Operating lease right-of-use assets | |
| 449,368 | | |
| 246,266 | |
Total Assets | |
$ | 142,384,181 | | |
$ | 175,697,097 | |
Liabilities and Stockholders’ Equity: | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 5,634,806 | | |
$ | 2,627,076 | |
Finance lease liabilities | |
| - | | |
| 2,449 | |
Operating lease liabilities | |
| 188,100 | | |
| 191,749 | |
Accrued expenses | |
| 6,887,136 | | |
| 4,060,280 | |
Total current liabilities | |
| 12,710,042 | | |
| 6,881,554 | |
Operating lease liabilities | |
| 270,925 | | |
| 61,002 | |
Note payable, non-current | |
| 36,506,774 | | |
| 34,983,074 | |
Total Liabilities | |
| 49,487,741 | | |
| 41,925,630 | |
Commitments and Contingencies (Note 5) | |
| - | | |
| - | |
Stockholders’ Equity: | |
| | | |
| | |
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 1,060,873 and 1,120,873 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| 1,061 | | |
| 1,121 | |
Common stock, $0.001 par value: 65,000,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively; 22,369,393 and 21,667,250 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| 22,369 | | |
| 21,667 | |
Additional paid-in capital | |
| 234,100,541 | | |
| 230,045,566 | |
Accumulated deficit | |
| (141,227,531 | ) | |
| (96,296,887 | ) |
Total Stockholders’ Equity | |
| 92,896,440 | | |
| 133,771,467 | |
Total Liabilities and Stockholders’ Equity | |
$ | 142,384,181 | | |
$ | 175,697,097 | |
See
accompanying notes to the financial statements
Celcuity
Inc.
Condensed
Statements of Operations
(unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 17,488,236 | | |
$ | 9,621,505 | | |
$ | 42,512,811 | | |
$ | 24,685,505 | |
General and administrative | |
| 1,409,801 | | |
| 1,022,050 | | |
| 3,988,248 | | |
| 3,066,382 | |
Total operating expenses | |
| 18,898,037 | | |
| 10,643,555 | | |
| 46,501,059 | | |
| 27,751,887 | |
Loss from operations | |
| (18,898,037 | ) | |
| (10,643,555 | ) | |
| (46,501,059 | ) | |
| (27,751,887 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (1,372,132 | ) | |
| (537,661 | ) | |
| (3,929,140 | ) | |
| (1,428,108 | ) |
Interest income | |
| 1,865,629 | | |
| 287,495 | | |
| 5,499,555 | | |
| 391,301 | |
Other income (expense), net | |
| 493,497 | | |
| (250,166 | ) | |
| 1,570,415 | | |
| (1,036,807 | ) |
Income tax benefits | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (18,404,540 | ) | |
$ | (10,893,721 | ) | |
$ | (44,930,644 | ) | |
$ | (28,788,694 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.83 | ) | |
$ | (0.75 | ) | |
$ | (2.05 | ) | |
$ | (1.95 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 22,117,626 | | |
| 14,938,224 | | |
| 21,920,147 | | |
| 14,928,727 | |
See
accompanying notes to the financial statements
Celcuity
Inc.
Condensed
Statements of Changes in Stockholders’ Equity
Three
and Nine Months Ended September 30, 2023
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
Common Stock | | |
Preferred Stock | | |
Additional Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
Balance at December 31, 2022 | |
| 21,667,250 | | |
$ | 21,667 | | |
| 1,120,873 | | |
$ | 1,121 | | |
$ | 230,045,566 | | |
$ | (96,296,887 | ) | |
$ | 133,771,467 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,273,282 | | |
| - | | |
| 1,273,282 | |
Exercise of common stock options, net of shares withheld for exercise price | |
| 24,122 | | |
| 24 | | |
| - | | |
| - | | |
| 127,898 | | |
| - | | |
| 127,922 | |
Conversion of preferred to common stock | |
| 250,000 | | |
| 250 | | |
| (25,000 | ) | |
| (25 | ) | |
| (225 | ) | |
| - | | |
| - | |
Issuance costs associated with private placement offering | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,486 | ) | |
| - | | |
| (7,486 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (11,938,417 | ) | |
| (11,938,417 | ) |
Balance at March 31, 2023 (unaudited) | |
| 21,941,372 | | |
$ | 21,941 | | |
| 1,095,873 | | |
$ | 1,096 | | |
$ | 231,439,035 | | |
$ | (108,235,304 | ) | |
$ | 123,226,768 | |
Stock-based compensation | |
| 1,958 | | |
| 2 | | |
| - | | |
| - | | |
| 1,276,980 | | |
| - | | |
| 1,276,982 | |
Employee stock purchases | |
| 17,477 | | |
| 17 | | |
| | | |
| | | |
| 102,621 | | |
| - | | |
| 102,638 | |
Conversion of preferred to common stock | |
| 100,000 | | |
| 100 | | |
| (10,000 | ) | |
| (10 | ) | |
| (90 | ) | |
| - | | |
| - | |
Exercise of common stock options, net of shares withheld for exercise price | |
| 21,086 | | |
| 22 | | |
| - | | |
| - | | |
| 113,618 | | |
| - | | |
| 113,640 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (14,587,687 | ) | |
| (14,587,687 | ) |
Balance at June 30, 2023
(unaudited) | |
| 22,081,893 | | |
$ | 22,082 | | |
| 1,085,873 | | |
$ | 1,086 | | |
$ | 232,932,164 | | |
$ | (122,822,991 | ) | |
$ | 110,132,341 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,108,637 | | |
| - | | |
| 1,108,637 | |
Conversion of preferred to common stock | |
| 250,000 | | |
| 250 | | |
| (25,000 | ) | |
| (25 | ) | |
| (225 | ) | |
| - | | |
| - | |
Exercise of common stock options, net of shares withheld for exercise price | |
| 37,500 | | |
| 37 | | |
| - | | |
| - | | |
| 59,965 | | |
| - | | |
| 60,002 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (18,404,540 | ) | |
| (18,404,540 | ) |
Balance
at September 30, 2023 (unaudited) | |
| 22,369,393 | | |
$ | 22,369 | | |
| 1,060,873 | | |
$ | 1,061 | | |
$ | 234,100,541 | | |
$ | (141,227,531 | ) | |
$ | 92,896,440 | |
See
accompanying notes to the financial statements
Celcuity
Inc.
Condensed
Statements of Changes in Stockholders’ Equity
Three
and Nine Months Ended September 30, 2022
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | |
|
Total |
|
| |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | |
|
Total |
|
Balance at December 31, 2021 | |
| 14,918,887 | | |
$ | 14,919 | | |
$ | 124,622,405 | | |
$ | (55,926,847 | ) | |
$ | 68,710,477 | |
Stock-based compensation | |
| - | | |
| - | | |
| 756,271 | | |
| - | | |
| 756,271 | |
Exercise of common stock options, net of shares withheld for exercise price | |
| 1,415 | | |
| 1 | | |
| 7,413 | | |
| - | | |
| 7,414 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (7,934,447 | ) | |
| (7,934,447 | ) |
Balance at March 31, 2022
(unaudited) | |
| 14,920,302 | | |
$ | 14,920 | | |
$ | 125,386,089 | | |
$ | (63,861,294 | ) | |
$ | 61,539,715 | |
Stock-based compensation | |
| 3,273 | | |
| 3 | | |
| 1,519,456 | | |
| - | | |
| 1,519,459 | |
Employee stock purchases | |
| 15,888 | | |
| 16 | | |
| 80,525 | | |
| - | | |
| 80,541 | |
Exercise of common stock options, net of shares withheld for exercise price | |
| 1,871 | | |
| 2 | | |
| 9,540 | | |
| - | | |
| 9,542 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (9,960,526 | ) | |
| (9,960,526 | ) |
Balance at June 30, 2022
(unaudited) | |
| 14,941,334 | | |
$ | 14,941 | | |
$ | 126,995,610 | | |
$ | (73,821,820 | ) | |
$ | 53,188,731 | |
Stock-based compensation | |
| 250 | | |
| - | | |
| 1,223,054 | | |
| - | | |
| 1,223,054 | |
Exercise of common stock options, net of shares withheld for exercise price | |
| 1,374 | | |
| 2 | | |
| 7,275 | | |
| - | | |
| 7,277 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (10,893,721 | ) | |
| (10,893,721 | ) |
Balance
at September 30, 2022 (unaudited) | |
| 14,942,958 | | |
$ | 14,943 | | |
$ | 128,225,939 | | |
$ | (84,715,541 | ) | |
$ | 43,525,341 | |
See
accompanying notes to the financial statements
Celcuity
Inc.
Condensed
Statements of Cash Flows
(unaudited)
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (44,930,644 | ) | |
$ | (28,788,694 | ) |
Adjustments to reconcile net loss to net cash used for operations: | |
| | | |
| | |
Depreciation | |
| 114,824 | | |
| 161,981 | |
Stock-based compensation | |
| 3,658,902 | | |
| 3,498,784 | |
Amortization of debt issuance costs and discount | |
| 177,939 | | |
| 284,184 | |
Payment-in-Kind interest | |
| 1,345,760 | | |
| 311,764 | |
Non-cash operating lease, net | |
| 3,171 | | |
| (2,791 | ) |
Change in accrued interest income | |
| (439,331 | ) | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Other current assets | |
| (1,065,732 | ) | |
| (5,817,737 | ) |
Accounts payable | |
| 3,031,923 | | |
| 1,553,176 | |
Accrued expenses | |
| 2,826,856 | | |
| 2,270,422 | |
Net cash used for operating activities | |
| (35,276,332 | ) | |
| (26,528,911 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Proceeds from maturities of investments | |
| 221,054,402 | | |
| - | |
Purchases of investments | |
| (184,779,534 | ) | |
| - | |
Purchases of property and equipment | |
| (64,945 | ) | |
| (46,724 | ) |
Net cash provided by (used for) investing activities | |
| 36,209,923 | | |
| (46,724 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from exercise of employee stock options | |
| 285,564 | | |
| 24,233 | |
Proceeds from employee stock purchases | |
| 102,638 | | |
| 80,541 | |
Payments for secondary registration statement costs | |
| (128,298 | ) | |
| (318,897 | ) |
Payments for debt issuance costs | |
| (2,716 | ) | |
| (8,463 | ) |
Payments for finance leases | |
| (2,449 | ) | |
| (4,384 | ) |
Net cash provided by (used for) financing activities | |
| 254,739 | | |
| (226,970 | ) |
Net change in cash and cash equivalents | |
| 1,188,330 | | |
| (26,802,605 | ) |
| |
| | | |
| | |
Cash and cash equivalents: | |
| | | |
| | |
Beginning of period | |
| 24,571,557 | | |
| 84,286,381 | |
End of period | |
$ | 25,759,887 | | |
$ | 57,483,776 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Interest paid | |
$ | 2,405,441 | | |
$ | 832,161 | |
Supplemental disclosures of non-cash investing and financing activities: | |
| | | |
| | |
Offering and registration statement costs included in accounts payable | |
$ | 13,865 | | |
$ | 11,230 | |
Deferred financing costs and offering and registration statement costs included in accrued expenses | |
| - | | |
| 205,000 | |
Property and equipment included in accounts payable | |
| 12,961 | | |
| 104,818 | |
See
accompanying notes to the financial statements
CELCUITY
INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (unaudited)
(For
the Three and Nine Months Ended September 30, 2023 and 2022)
1.
Organization
Nature
of Business
Celcuity
Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company pursuing development for oncology.
The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic
properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.
A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients
with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib
in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is expected to be initiated in the
first quarter of 2024. The company’s CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells
to identify new groups of cancer patients likely to benefit from already approved targeted therapies. The Company was co-founded in 2012
by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company has not generated any revenues to date.
2.
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
Basis
of Presentation
The
accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10
of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article 10,
the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the
United States (“U.S. GAAP”). The balance sheet at December 31, 2022 was derived from the audited financial statements at
that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of
a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed
financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2022
and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Operating
results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected during the
remainder of the current year or for any future period.
Accounting
Estimates
Management
uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S. GAAP. Those estimates
and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported
revenues and expenses. Actual results could differ from those estimates and the difference could be material. Significant items subject
to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.
Risks
and Uncertainties
The
Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and
commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests and initial drug product, gedatolisib,
the clinical and commercial success of gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of
broad adoption of its approved products, if any, by physicians and consumers, and significant competition.
Clinical
Trial Costs
The
Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers,
which includes the conduct of preclinical studies and clinical trials. These costs can be a significant component of the Company’s
research and development expenses. The Company primarily relies on a compilation of progress reports from third-party service providers,
including the respective invoicing, to record actual expenses, along with determining changes to prepaid assets and accrued liabilities.
To date, the company believes utilization of third-party reports most accurately reflects expenses incurred. As the current VIKTORIA-1
Phase 3 trial ramps up site activation and patient enrollment, the Company’s estimated expenses in future periods and actual services
performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material
changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.
Recently
Adopted Accounting Pronouncements
In
June 2016 and related amendments, the FASB issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit
Losses (Topic 326). This guidance changes the methodology to be used to measure credit losses for certain financial instruments and financial
assets. The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to
be incurred over the life of the financial asset. The Company adopted this standard effective January 1, 2023. The adoption of the standard
did not have a material impact on the Company’s consolidated financial statements.
3.
Net Loss Per Common Share
Basic
and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average
common shares outstanding during the period. For all periods presented, the common shares underlying the preferred stock, options, warrants,
and restricted stock have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average
shares outstanding used to calculate both basic and diluted loss per common share is the same.
For
the three and nine months ended September 30, 2023 and 2022, potentially dilutive securities excluded from the computations of diluted
weighted-average shares outstanding were preferred stock on an as-if-converted to common stock basis of 10,608,730 and zero shares of
common stock, respectively, options to purchase 2,702,629 and 1,919,114 shares of common stock, respectively, warrants to purchase 7,266,102
and 309,652 shares of common stock, respectively, and 1,958 and 3,273 shares of restricted common stock, respectively.
4.
Investments
Debt
securities for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported
at historical cost adjusted for amortization of premiums and accretion of discounts. Expected credit losses, if any, are recorded through
the establishment of an allowance for credit losses. All of the Company’s held-to-maturity
investment securities are U.S. Treasury and agencies securities that are guaranteed or otherwise
supported by the United States government and have no history of credit losses. Accordingly, the Company does not expect to incur any
credit losses on held-to-maturity investment securities and has no allowance
for credit losses recorded for these securities.
The
following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of September 30, 2023 and
December 31, 2022:
Schedule of Investment
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
September 30, 2023 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
| | |
| | |
| | |
| |
U.S. Treasury Bills | |
$ | 108,180,417 | | |
$ | 5,138 | | |
$ | - | | |
$ | 108,185,555 | |
Total | |
$ | 108,180,417 | | |
$ | 5,138 | | |
$ | - | | |
$ | 108,185,555 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
December 31, 2022 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
| | |
| | |
| | |
| |
Governmental Agency Securities | |
$ | 46,230,893 | | |
$ | 29,517 | | |
$ | - | | |
$ | 46,260,410 | |
U.S. Treasury Bills | |
| 97,785,061 | | |
| 41,639 | | |
| - | | |
| 97,826,700 | |
Total | |
$ | 144,015,954 | | |
$ | 71,156 | | |
$ | - | | |
$ | 144,087,110 | |
The
fair value of the Company’s held-to-maturity debt securities is determined based upon inputs, other than the quoted prices in active
markets, that are observable either directly or indirectly and are classified as level 2 fair value instruments.
5.
Commitments
Operating
Lease
The
Company leases its corporate space in Minneapolis, Minnesota, with an operating lease in place through April 30, 2026. The lease provides
for monthly rent, real estate taxes, and operating expenses. Rent expense is recorded on a straight-line basis over the lease term. In
March 2023, the Company signed the fourth amendment to extend this lease through April 30, 2026. This amendment provides for monthly
rent, real estate taxes and operating expenses. The Company recorded an incremental $355,578 in the operating right-of-use (“ROU”)
asset and lease liability pertaining to this amendment.
Clinical
Research Studies
The
Company enters into contracts in the normal course of business to conduct research and development programs internally and through third
parties that include, among others, arrangements with vendors, consultants, CMO’s, and CRO’s. The Company currently has four
Phase 2 clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia tests. Timing of milestone
payments related to the Phase 2 clinical trials are uncertain and the contracts generally provide for termination following a certain
period after notice, therefore the Company believes that non-cancelable obligations under the agreements are not material. The Company
also has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib. In conjunction with
the license agreement, the Company continued a Phase 1b study – B2151009 related to gedatolisib. These patients subsequently transitioned
to an Expanded Access study – CELC-G-001. Contracts related to the Expanded Access study, are generally based on time and material.
In addition, contracts related to the Company’s Phase 3 (VIKTORIA-1) and Phase 1b/2 (CELC-G-201) clinical trials are generally
cancelable with reasonable notice within 120 days and the Company’s obligations under these contracts are primarily based on services
performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition,
these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties. As of September
30, 2023, the Company had two material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately
$2.3 million.
6.
Stockholders’ Equity
Capital
Stock
At
December 31, 2022, the Company’s authorized capital stock consisted of 65,000,000 shares of $.001 par value common stock, of which
21,667,250 shares were outstanding, and 2,500,000 shares of $.001 par value preferred stock, of which 1,120,873 shares were outstanding.
On
March 31, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred
Stock into 250,0000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis of
the shares transferred is $5.75 per share.
On
June 29, 2023, one of the Company’s preferred shareholders elected to convert 10,000 shares of Series A Convertible Preferred Stock
into 100,0000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis of the
shares transferred is $5.75 per share.
On
September 21, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred
Stock into 250,0000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis of
the shares transferred is $5.75 per share.
At
September 30, 2023, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 22,369,393
shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock,
of which 1,060,873 shares were outstanding. As of September 30, 2023, no dividends have been declared on the Company’s capital
stock.
7.
Stock-Based Compensation
The
following table summarizes the activity for all stock options outstanding for the nine months ended September 30:
Schedule of Stock Options Activity
| |
2023 | | |
2022 | |
| |
Shares | | |
Weighted Average Exercise Price | | |
Shares | | |
Weighted Average Exercise Price | |
Options outstanding at beginning of year | |
| 1,976,586 | | |
$ | 6.34 | | |
| 1,315,321 | | |
$ | 11.97 | |
Granted | |
| 874,548 | | |
| 10.13 | | |
| 720,047 | | |
| 7.19 | |
Exercised | |
| (82,708 | ) | |
| 3.65 | | |
| (4,660 | ) | |
| 5.20 | |
Forfeited | |
| (65,797 | ) | |
| 7.45 | | |
| (111,594 | ) | |
| 10.86 | |
Balance at September 30 | |
| 2,702,629 | | |
$ | 7.63 | | |
| 1,919,114 | | |
$ | 6.08 | |
| |
| | | |
| | | |
| | | |
| | |
Options exercisable at September 30: | |
| 1,440,231 | | |
$ | 6.26 | | |
| 882,215 | | |
$ | 5.92 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Grant Date Fair Value for options granted during the period: | |
| | | |
$ | 7.09 | | |
| | | |
$ | 4.87 | |
The
following table summarizes additional information about stock options outstanding and exercisable at September 30, 2023:
Schedule of Stock Options Outstanding and Exercisable
Options Outstanding | |
Options Exercisable |
Options Outstanding | |
Weighted Average Remaining Contractual Life | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | | |
Options Exercisable | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
2,702,629 | |
| 8.09 | | |
$ | 7.63 | | |
$ | 5,355,467 | | |
1,440,231 | |
$ | 6.26 | | |
$ | 4,470,641 | |
The
Company recognized stock-based compensation expense for stock options of $1,065,568 and $1,162,751 for the three months ended September
30, 2023 and 2022, respectively, and $3,516,180 and $3,329,969 for the nine months ended September 30, 2023 and 2022, respectively. In
May 2022, the Company modified the exercise price on 776,324 stock option awards to $5.50, the closing market price on the Nasdaq Capital
Market on May 17, 2022. The effect of this modification on stock-based compensation was $30,188 and $49,088 for the three months ending
September 30, 2023 and 2022, respectively, and $107,490 and $477,431 for the nine months ending September 30, 2023 and 2022, respectively.
The effect of this modification on stock-based compensation over the remaining service period will be approximately $190,000. In December
2021, the Company modified the exercise price on 311,000 stock option awards to $13.44, the closing market price on the Nasdaq Capital
Market on December 15, 2021. No director or officer awards were modified. The effect of this modification on stock-based compensation
was $15,773 and $21,778 for the three months ended September 30, 2023 and 2022, respectively, and $49,617 and $75,562 for the nine months
ended September 30, 2023 and 2022, respectively. The effect of this modification on stock-based compensation over the remaining service
period will be approximately $114,000. In May 2020, the Company modified the exercise price on 203,750 stock option awards to $5.10,
the closing market price on the Nasdaq Capital Market on May 14, 2020. No director or officer awards were modified. The effect of this
modification on stock-based compensation was $3,041 and $7,681 for the three months ended September 30, 2023 and 2022, respectively,
and $16,975 and $30,897 for the nine months ended September 30, 2023 and 2022. The effect of this modification on stock-based compensation
over the remaining service period will be approximately $3,000.
The
Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions
for the nine months ended September 30:
Schedule of Assumptions for Fair Value of Equity-based Awards
| |
2023 | | |
2022 | |
Risk-free interest rate | |
| 3.41% - 4.61% | | |
| 1.68% - 3.93% | |
Expected volatility | |
| 78.0 to 79.8% | | |
| 76.2% - 79.6% | |
Expected life (years) | |
| 5.25 to 6.08 | | |
| 5.29 to 6.25 | |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
The
inputs for the Black-Scholes valuation model require management’s significant assumptions. Prior to the Company’s initial
public offering, the price per share of common stock was determined by the Company’s board based on recent prices of common stock
sold in private offerings. Subsequent to the initial public offering, the price per share of common stock is determined by using the
closing market price on the Nasdaq Capital Market on the grant date. The risk-free interest rates are based on the rate for U.S. Treasury
securities at the date of grant with maturity dates approximately equal to the expected life at the grant date. The expected life is
based on the simplified method in accordance with the SEC Staff Accounting Bulletin Nos. 107 and 110. The expected volatility is estimated
based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated
volatility since being publicly traded.
All
assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for
options granted to employees. In the event the Company terminates any of its consulting agreements, the unvested options issued in connection
with the agreements would also be cancelled.
The
Company had 1,958 and 3,273 shares of restricted stock outstanding as of September 30, 2023 and 2022, respectively, and 0 and 250 shares
of restricted stock vested during the three months ended September 30, 2023 and 2022, respectively. The Company recognized stock-based
compensation expense for restricted stock of $4,903 and $7,245 for the three months ended September 30, 2023 and 2022, respectively,
and $13,597 and $36,686 for the nine months ended September 30, 2023 and 2022, respectively.
The
Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Amended and Restated Stock Incentive
Plan (the “2017 Plan”). The number of shares reserved for issuance was automatically increased by 102,998, 149,189 and 216,673
shares on January 1, 2021, 2022 and 2023, respectively, and will increase automatically on January 1 of each year from 2024 through 2027
by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding
December 31, subject to the board’s discretion to reduce the amount of the increase in any particular year. At the Annual Meetings
held on May 12, 2021 and May 12, 2022, the stockholders approved a one-time, 500,000 increase each year for a total of 1,000,000 increase,
to the number of shares reserved for issuance under the 2017 Plan. At the Annual Meeting held on May 11, 2023, the stockholders approved
a one-time, 1,500,000 increase to the number of shares reserved for issuance under the 2017 plan. The total remaining shares available
for grant under the Company’s 2017 Plan as of September 30, 2023 was 1,147,899.
Total
unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows:
Schedule of Unrecognized Compensation Cost
2023 | |
$ | 1,177,419 | |
| |
| |
2023 | |
$ | 1,177,419 | |
2024 | |
| 3,679,163 | |
2025 | |
| 2,465,972 | |
2026 | |
| 1,515,642 | |
2027 | |
| 635,575 | |
Total estimated compensation cost to be recognized | |
$ | 9,473,771 | |
The
Company recognized stock-based compensation expense related to its employee stock purchase plan of $38,167 and $53,058 for the three
months ended September 30, 2023 and 2022, respectively and $129,125 and $132,129 for the nine months ended September 30, 2023 and 2022,
respectively. The Company initially reserved a total of 100,000 shares for issuance under the employee stock purchase plan. The number
of shares reserved for issuance was automatically increased by 51,499, 74,594 and 108,337 shares on January 1, 2021, 2022 and 2023, respectively,
and will increase automatically on each subsequent January 1 by the number of shares equal to 0.5% of the total outstanding number of
shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount
of the increase in any particular year. The total remaining shares available for issuance under the employee stock purchase plan as of
September 30, 2023 was 283,008.
The
Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30:
Schedule of Stock-based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Stock-based compensation expense in operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 660,706 | | |
$ | 676,524 | | |
$ | 1,954,689 | | |
$ | 1,937,707 | |
General and administrative | |
| 447,931 | | |
| 546,530 | | |
| 1,704,213 | | |
| 1,561,077 | |
Total | |
$ | 1,108,637 | | |
$ | 1,223,054 | | |
$ | 3,658,902 | | |
$ | 3,498,784 | |
8.
Debt
On
April 8, 2021, the Company entered into a loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences
Lending Fund I, LP, a Delaware limited partnership (“Innovatus”) in its capacity as Collateral Agent and sole Lender. On
August 9, 2022, the Company amended the Loan Agreement. Under the amended Loan Agreement, Innovatus, as Lender, has agreed to loan up
to $75 million, a $50 million increase from the original Loan Amount. As of September 30, 2023, term loans totaling $35 million are outstanding
under the Loan Agreement, including the initial Term A loan of $15 million which was funded on April 8, 2021, and a $20 million Term
B loan which was funded on December 22, 2022.
Long-term
debt consisted of the following at September 30, 2023 and December 31, 2022:
Schedule of Long-term Debt
| |
September 30, 2023 | | |
December 31, 2022 | |
Note payable | |
$ | 35,000,000 | | |
$ | 35,000,000 | |
Add: PIK interest (added to principal) | |
| 2,100,835 | | |
| 755,075 | |
Less: unamortized debt issuance costs | |
| (540,392 | ) | |
| (707,001 | ) |
Less: unamortized debt discount | |
| (53,669 | ) | |
| (65,000 | ) |
Total long-term debt | |
$ | 36,506,774 | | |
$ | 34,983,074 | |
Future
principal payments, including the incurred PIK interest, are as follows:
Schedule of Long Term Debt Future Principal Payments
| |
Years
Ending December 31, | |
| |
| |
2025 | |
$ | 13,912,813 | |
2026 | |
| 18,550,418 | |
2027 | |
| 4,637,604 | |
Total | |
$ | 37,100,835 | |
9.
Subsequent Events
On
October 18, 2023, the Company entered into a securities purchase agreement with certain investors (the “Investors”) pursuant
to which the Company agreed to sell to the Investors in a private placement (the “Private Placement”) pre-funded warrants
(the “Warrants”) to purchase up to 5,747,787 shares of the Company’s common stock, par value $0.001 per share (the
“Common Stock”). Each Warrant is immediately exercisable and will not expire. Each warrant to purchase one share has a purchase
price of $8.699 per share, and an exercise price of $0.001 per share for the Common Stock issuable upon exercise of the Warrant.
The
closing of the Private Placement occurred on October 20, 2023 and resulted in gross proceeds to the Company of approximately $50 million,
before deducting offering expenses payable by the Company.
In
connection with the Private Placement, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”)
with the Investors, pursuant to which the Company has agreed to file, no later than 30 days following the Closing Date of the Private
Placement, a registration statement covering the resale by the Investors of the shares issued or issuable upon exercise or exchange of
the Warrants (as defined more specifically in the Registration Rights Agreement, the “Registrable Securities”).
In
the event that a registration statement covering the Registrable Securities is not filed with the SEC on or prior to the filing deadline
as set forth in the Registration Rights Agreement, or is not declared effective within the timeframe provided therein, or if certain
other circumstances occur, as described in the Registration Rights Agreement, that prevent the Investors from selling securities pursuant
to the registration statement, the Company has agreed to make pro rata payments to each holder as liquidated damages in an amount equal
to 1.0% of the aggregate amount paid pursuant to the Securities Purchase Agreement by such Investor for each 30-day period or pro rata
for any portion thereof for each such month during which such event continues, provided that the maximum aggregate amounts payable as
liquidated damages shall not exceed 6.0% of the aggregate amount invested by each such holder in the Registrable Securities then held
by the holder.
On
October 13, 2023, one of the Company’s preferred shareholders elected to convert 181,739 shares of Series A Convertible Preferred
Stock into 1,817,390 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis
of the shares transferred is $5.75 per share.
ITEM
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You
should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed
financial statements and the related notes appearing under Item 1 of Part I of this Quarterly Report on Form 10-Q (this “Quarterly
Report”). This Quarterly Report, including the following discussion and analysis, contains forward-looking statements that involve
risks and uncertainties and speak only as of the date of this report. Forward-looking information is included in our discussion of our
plans and strategy for our business and expected financial results. You should review the “Risk Factors” discussed in our
Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 23, 2023, and the information contained
elsewhere in this Quarterly Report, for a discussion of important factors that could cause actual results to differ materially from the
results described in or implied by forward-looking statements.
Overview
Celcuity
is a clinical-stage biotechnology company focused on the development of targeted therapies for oncology. The Company’s lead therapeutic
candidate is gedatolisib, a pan-PI3K/mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated
from other currently approved and investigational therapies that target PI3K or mTOR alone or together. The Company initiated VIKTORIA-1,
a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022 and is currently enrolling patients.
In addition to the Phase 3 study, the Company recently announced that it received U.S. Food and Drug Administration (“FDA”)
clearance for its Investigational New Drug (IND) submission for the clinical development of gedatolisib in combination with Nubeqa®
(darolutamide), for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). The Company expects
to initiate a Phase 1b/2 study, CELC-G-201, in the first quarter of 2024. Its CELsignia companion diagnostic platform is uniquely able
to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.
Gedatolisib,
is a potent, well-tolerated, small molecule reversible dual inhibitor, administered intravenously, that selectively targets all Class
I isoforms of PI3K and mammalian target of rapamycin (mTOR). In April 2021, we obtained exclusive global development and commercialization
rights to gedatolisib under a license agreement with Pfizer, Inc. We believe gedatolisib’s unique mechanism of action, differentiated
chemical structure, favorable pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved
and investigational therapies that target PI3K or mTOR alone or together.
| ● | Overcomes
limitations of therapies that only inhibit a single Class I PI3K isoform or only one mTOR
kinase complex. |
Gedatolisib
is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms
and mTORC1 and mTORC2 complexes. Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction events
that involve tumor cell survival, depending upon the aberrations associated with the linked pathway. When a therapy only inhibits a single
Class I isoform (e.g., alpelisib, a PI3K-α inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor),
numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units. This,
in turn, induces compensatory resistance that can reduce the efficacy of isoform specific PI3K or single mTOR kinase complex inhibitors.
Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding effect of isoform interaction
that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms and mTOR.
| ● | Better
tolerated by patients than oral PI3K and mTOR drugs. |
Gedatolisib
is administered intravenously (IV) on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K
or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably been
found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion of patients
requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately played a
significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisib stabilizes
at lower concentration levels in plasma compared to orally administered PI3K inhibitors, resulting in less toxicity, while maintaining
concentrations sufficient to inhibit PI3K/mTOR signaling.
Isoform-specific
PI3K inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with isoform-specific
inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis still leads to challenging
toxicities. The experience with an FDA approved oral p110-α specific inhibitor, Piqray, illustrates the challenge. In its Phase
3 pivotal trial Piqray was found to induce a Grade 3 or 4 adverse event (AE) related to hyperglycemia in 39% of patients evaluated. In
addition, 26% of patients discontinued alpelisib due to treatment related adverse events. By contrast, in the 103-patient dose expansion
portion of the Phase 1b (B2151009) clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less
than 10% discontinued treatment.
As
of September 30, 2023, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials sponsored by Pfizer.
Of the 492 patients, 129 were treated with gedatolisib as a single agent in three clinical trials. The remaining 363 patients received
gedatolisib in combination with other anti-cancer agents in five clinical trials. Additional patients received gedatolisib in combination
with other anti-cancer agents in nine investigator sponsored clinical trials.
A
Phase 1b trial (B2151009) evaluating patients with HR+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled
138 patients. Six patients from this study continue to receive study treatment, as of September 30, 2023, each of whom have received
study treatment for more than four years. The B2151009 clinical was an open label, multiple arm Phase 1b study that evaluated gedatolisib
in combination with palbociclib (CDK4/6 inhibitor) and endocrine therapy (fulvestrant or letrozole) in patients with HR+/HER2- advanced
breast cancer. Thirty-five patients were enrolled in two dose escalation arms to evaluate the safety and tolerability and to determine
the maximum tolerated dose (MTD) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapy.
The MTD was determined to be 180 mg administered intravenously once weekly. A total of 103 patients were subsequently enrolled in one
of four expansion arms (A, B, C, D).
High
objective overall response rates (ORR) were observed in all four expansion arms and were comparable in each arm for PIK3CA WT and PIK3CA
MT patients. As of the data cut-off date, March 16, 2023, for treatment- naïve patients in Escalation Arm A and Expansion Arm A
(n=41), median progression free survival (mPFS) was 48.6 months, median duration of response (mDOR) was 46.9 months, and ORR was 79%.
respectively. This data compares favorably to published data for current first-line standard-of-care treatments for patients with HR+/HER2-
advanced breast cancer. In patients who received prior hormonal therapy alone or in combination with a CDK4/6 inhibitor (Arms B, C, and
D), ORR (including unconfirmed partial responses) ranged from 36% to 77%. Each arm achieved its primary endpoint target, which was reporting
higher ORR in the study arm than ORR from either the PALOMA-2 (ORR=55%) study that evaluated palbociclib plus letrozole for Arm A or
the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D. For all enrolled patients, a clinical
benefit rate (CBR) of ≥79% was observed. Median progression-free survival (PFS) was 12.9 months for patients who received a prior
CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm D).
Gedatolisib
combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity. The majority of treatment
emergent adverse events were Grade 1 and 2. The most frequently observed adverse events included stomatitis/mucosal inflammation, the
majority of which were Grade 1 and 2. The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed
as related to treatment with palbociclib. No grade 5 events were reported in this study.
We
are currently enrolling patients in a Phase 3, open-label, randomized clinical trial (VIKTORIA-1) to evaluate the efficacy and safety
of two regimens in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK4/6 therapy in combination
with an aromatase inhibitor: 1) gedatolisib in combination with palbociclib and fulvestrant; and 2) gedatolisib in combination with fulvestrant.
Approximately two hundred clinical sites in North America, Europe, South America, Asia, and Australia have been selected to participate
in the study. The first clinical site was activated in the third quarter of 2022, and the first patient was dosed in December 2022.
The
VIKTORIA-1 Phase 3 clinical trial will enable separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility
criteria and are PIK3CA WT will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant
(Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). Subjects who meet eligibility criteria and are PIK3CA MT will be
randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), or alpelisib and fulvestrant
(Arm E), or gedatolisib and fulvestrant (Arm F).
The
CELC-G-201 Phase 1b/2 clinical trial will enroll up to 54 participants with mCRPC who progressed after metastic castration resistant
prostate cancer (“mCRPC”) treatment with a next-generation androgen receptor inhibitor and have not received docetaxel
for mCRPC. In the Phase 1b portion of the study, we expect 36 participants will be randomly assigned to receive 600 mg darolutamide
administered orally twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib received intravenously in Arm
2. An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the Recommended Phase 2 Dose (RP2D)
level to enable evaluation of 30 participants treated with the RP2D of gedatolisib. The primary objectives of the Phase 1b portion
of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of
the RP2D dose of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the
radiographic progression-free survival (rPFS) at six months of patients who received the RP2D. We expect to initiate the study in
the first quarter of 2024.
Our
proprietary CELsignia diagnostic platform is the only commercially ready technology we are aware of that uses a patient’s living
tumor cells to identify the specific abnormal cellular process driving a patient’s cancer and the targeted therapy that best treats
it. This enables us to identify patients whose tumors may respond to a targeted therapy, even though they lack a previously associated
molecular mutation. By identifying cancer patients whose tumors lack an associated genetic mutation but have abnormal cellular activity
a matching targeted therapeutic is designed to inhibit, CELsignia CDx can expand the markets for a number of already approved targeted
therapies. We are supporting the advancement of new potential indications for targeted therapies, controlled by other pharmaceutical
companies, that would rely on a CELsignia CDx to select patients. Phase 2 trials are underway to evaluate the efficacy and safety of
these therapies in CELsignia selected patients. The FACT-1 trial is expected to have interim results available in the first half of 2024
and final results approximately nine months later. The FACT-2 trial, which was evaluating patients with early-stage triple negative breast
cancer, was terminated in the third quarter. This decision was made in response to recent FDA approvals of new therapeutic options for
patients with early-stage triple negative breast cancer. The availability of these new therapeutic options negatively impacted enrollment,
which led us to conclude that the study was no longer feasible.
Under
our April 2021 license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib, we paid a $5.0 million
upfront fee and granted to Pfizer $5.0 million shares of Company common stock, which fee and grant were effected and expensed to research
& development in full for the quarter in which we signed the license agreement. In addition, we are also required to make milestone
payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $335.0 million. Additionally,
the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject
to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition. Unless earlier terminated,
the license agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country
basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration
of all regulatory or data exclusivity in such country for such product or (c) the date upon which the manufacture, use, sale, offer for
sale or importation of such product in such country would no longer infringe, but for the license granted in the license agreement, on
a valid claim of a licensed patent right.
The
Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate
the agreement for convenience. Either the Company or Pfizer may terminate the license agreement if the other party is in material breach
and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the license agreement
in the event of specified insolvency events involving the other party.
Recent
Developments
In
October 2023, Celcuity announced that it entered into a securities purchase agreement to sell pre-funded warrants at a price of $8.70
per warrant, to purchase up to 5,747,787 shares of the Company’s common stock in a private placement. The closing of the private
placement occurred on October 20, 2023 and resulted in gross proceeds of approximately $50 million. Each Warrant to purchase one share
has a purchase price of $8.699 per share, and an exercise price of $0.001 per share for the Common Stock issuable upon exercise of the
Warrant (for aggregate consideration equating to $8.70 per share). The Company expects to use the net proceeds to advance clinical development
of gedatolisib and for general corporate purposes. The Company has entered into a Registration Rights Agreement in connection with the
private placement, pursuant to which it has agreed to register for resale the shares issuable upon exercise or exchange of the Warrants.
In
August 2023, Celcuity announced it entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity’s
Phase 1b/2 clinical trial of gedatolisib and Nubeqa® (darolutamide) in patients with metastatic castration resistant prostate cancer
(mCRPC). As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost.
In
August 2023, Celcuity announced it was notified by the FDA that its Investigational New Drug (IND) submission has been reviewed, and
Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved
androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).
Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an
androgen receptor inhibitor. The Company expects to begin enrolling patients in the Phase 1b/2 clinical trial in the first quarter
of 2024.
Impact
of COVID-19 on our Business
Although
we have largely returned to normal operations in our facility, the COVID-19 pandemic continues and its effect on our operations and financial
condition will depend in large part on future developments which cannot be reasonably estimated at this time. Future developments include
the duration, scope and severity of the pandemic, the emergence of new virus variants that are more contagious or harmful than prior
variants, actions taken by governmental authorities, suppliers, clinical trial sites, and other business partners to contain or mitigate
the pandemic’s impact, and the potential adverse effects on the suppliers, labor market and general economic activity.
Results
of Operations
We
have not generated any revenue from sales to date, and we continue to incur significant research and development and other expenses related
to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception
in 2012. For the three months ended September 30, 2023 and 2022, we reported a net loss of approximately $18.4 million and $10.9 million,
respectively, and for the nine months ended September 30, 2023 and 2022, we reported a net loss of approximately $44.9 million and $28.8
million, respectively. As of September 30, 2023, we had an accumulated deficit of approximately $141.2 million. As of September
30, 2023, we had cash and cash equivalents and short-term investments of approximately $133.9 million.
Components
of Operating Results
Revenue
To
date, we have not generated any revenue. With the execution of the Pfizer license agreement in April 2021, whereby we acquired exclusive
world-wide licensing rights to develop and commercialize gedatolisib, we initiated a Phase 3 clinical trial, VIKTORIA-1, in 2022 to support
potential regulatory approval to market gedatolisib for the treatment of breast cancer. In August 2023, Celcuity announced its plans
to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor
inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). If we obtain regulatory approvals
to market gedatolisib, we expect to generate revenue from sales of the drug for the treatment of patients who present with the forms
of breast or prostate cancer for which gedatolisib has been approved.. Additionally, we will seek to generate revenue from partnership
agreements with pharmaceutical companies to provide companion diagnostics for such pharmaceutical partners’ existing or investigational
targeted therapies. If a new drug indication is received that requires use of our companion diagnostic to identify eligible patients,
we expect to generate revenues from sales of tests to treating physicians.
Research
and Development
Since
our inception, we have primarily focused on research and development of gedatolisib, a PI3K/mTOR targeted therapy, and our CELsignia
platform and corresponding tests. Research and development expenses primarily include:
|
● |
employee-related
expenses related to our research and development activities, including salaries, benefits, recruiting, travel and stock-based compensation
expenses; |
|
● |
laboratory
supplies; |
|
● |
consulting
fees paid to third parties; |
|
● |
clinical
trial costs; |
|
● |
validation
costs for gedatolisib; |
|
● |
facilities
expenses; and |
|
● |
legal
costs associated with patent applications. |
Internal
and external research and development costs are expensed as they are incurred. As we continue to develop gedatolisib and manage studies
and clinical trials, including the VIKTORIA-1 Phase 3 trial, the CELC-G-201 trial, and other clinical trials to evaluate the efficacy
of targeted therapies in cancer patients selected with one of our CELsignia tests, the proportion of research and development expenses
allocated to external spending will grow at a faster rate than expenses allocated to internal expenses.
General
and Administrative
General
and administrative expenses consist primarily of salaries, benefits and stock-based compensation related to our executive, finance and
support functions. Other general and administrative expenses include professional fees for auditing, tax, and legal services associated
with being a public company, director and officer insurance, investor relations and travel expenses for our general and administrative
personnel.
Sales
and Marketing
Sales
and marketing expenses consist primarily of professional and consulting fees related to these functions. To date, we have incurred immaterial
sales and marketing expenses as we continue to focus primarily on developing our first drug, gedatolisib, managing the VIKTORIA-1 Phase
3 trial, initiating the CELC-G-201 study, and developing our CELsignia platform and corresponding CELsignia tests. We would expect to
begin to incur increased sales and marketing expenses in anticipation of the commercialization of our first drug, gedatolisib. These
increased expenses are expected to include employee-related and consulting costs.
Interest
Expense
Interest
expense is primarily due to a Loan Agreement.
Interest
Income
Interest
income consists of interest income earned on our cash equivalents and investment balances.
Results
of Operations
Comparison
of the Three Months Ended September 30, 2023 and 2022
| |
Three Months Ended | | |
| |
| |
September 30, | | |
Increase (Decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
Percent Change | |
Statements of Operations Data: | |
| | |
| | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 17,488,236 | | |
$ | 9,621,505 | | |
$ | 7,866,731 | | |
| 82 | % |
General and administrative | |
| 1,409,801 | | |
| 1,022,050 | | |
| 387,751 | | |
| 38 | |
Total operating expenses | |
| 18,898,037 | | |
| 10,643,555 | | |
| 8,254,482 | | |
| 78 | |
Loss from operations | |
| (18,898,037 | ) | |
| (10,643,555 | ) | |
| (8,254,482 | ) | |
| 78 | |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (1,372,132 | ) | |
| (537,661 | ) | |
| (834,471 | ) | |
| 155 | |
Interest income | |
| 1,865,629 | | |
| 287,495 | | |
| 1,578,134 | | |
| 549 | |
Other income (expense), net | |
| 493,497 | | |
| (250,166 | ) | |
| 743,663 | | |
| (297 | ) |
Net loss before income taxes | |
| (18,404,540 | ) | |
| (10,893,721 | ) | |
| (7,510,819 | ) | |
| 69 | |
Income tax benefits | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (18,404,540 | ) | |
$ | (10,893,721 | ) | |
$ | (7,510,819 | ) | |
| 69 | % |
Comparison
of the Nine Months Ended September 30, 2023 and 2022
| |
Nine Months Ended | | |
| |
| |
September 30, | | |
Increase (Decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
Percent Change | |
Statements of Operations Data: | |
| | |
| | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 42,512,811 | | |
$ | 24,685,505 | | |
$ | 17,827,306 | | |
| 72 | % |
General and administrative | |
| 3,988,248 | | |
| 3,066,382 | | |
| 921,866 | | |
| 30 | |
Total operating expenses | |
| 46,501,059 | | |
| 27,751,887 | | |
| 18,749,172 | | |
| 68 | |
Loss from operations | |
| (46,501,059 | ) | |
| (27,751,887 | ) | |
| (18,749,172 | ) | |
| 68 | |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (3,929,140 | ) | |
| (1,428,108 | ) | |
| (2,501,032 | ) | |
| 175 | |
Interest income | |
| 5,499,555 | | |
| 391,301 | | |
| 5,108,254 | | |
| 1,305 | |
Other income (expense), net | |
| 1,570,415 | | |
| (1,036,807 | ) | |
| 2,607,222 | | |
| (251 | ) |
Net loss before income taxes | |
| (44,930,644 | ) | |
| (28,788,694 | ) | |
| (16,141,950 | ) | |
| 56 | |
Income tax benefits | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (44,930,644 | ) | |
$ | (28,788,694 | ) | |
$ | (16,141,950 | ) | |
| 56 | % |
Research
and Development
Our
research and development expenses for the three months ended September 30, 2023 were approximately $17.5 million, representing an increase
of approximately $7.9 million, or 82%, compared to the same period in 2022. Of the $7.9 million increase in research and development
expense, $0.4 million was related to increased employee-related expenses. The remaining $7.5 million increase of research and
development costs is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial.
Our
research and development expenses for the nine months ended September 30, 2023 were approximately $42.5 million, representing an increase
of approximately $17.8 million, or 72%, compared to the same period in 2022. Of the $17.8 million increase in research and development
expenses, $1.8 million was related to increased employee and consulting expenses. The remaining $16.0 million increase of research and
development expenses is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial.
Conducting
a significant amount of research and development is central to our business model. We plan to increase our research and development expenses
for the foreseeable future as we seek to develop gedatolisib, manage the VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial,
discover new cancer sub-types, and develop and validate additional CELsignia tests to diagnose such sub-types. We also expect to incur
increased expenses to support companion diagnostic business development activities with pharmaceutical companies as we develop additional
CELsignia tests and manage the clinical trials for gedatolisib.
General
and Administrative
Our
general and administrative expenses for the three months ended September 30, 2023 were approximately $1.4 million, representing an increase
of approximately $0.4 million, or 38%, compared to the same period in 2022. Employee related expenses accounted for $0.3 million of the
increase. The remaining $0.1 million increase resulted from professional fees and other expenses associated with being a public company.
Our
general and administrative expenses for the nine months ended September 30, 2023 were approximately $4.0 million, representing an increase
of approximately $0.9 million, or 30%, compared to the same period in 2022. Employee related expenses accounted for $0.7 million of the
$0.9 million increase, including approximately $0.2 million in non-cash stock-based compensation. The remaining $0.2 million of the increase
resulted from professional fees and other expenses associated with being a public company.
We
anticipate that our general and administrative expenses will increase in future periods, reflecting both increased costs in connection
with the potential future commercialization of gedatolisib and CELsignia tests, an expanding infrastructure, and increased professional
fees associated with public company regulatory developments and other compliance matters.
Interest
Expense
Interest
expense for the three months ended September 30, 2023 was $1.4 million and represents an increase of $0.8 million, or 155%, compared
to the same period in 2022. Interest expense is primarily the result of a Loan Agreement that was executed in April 2021 and amended
in August 2022. The increase is primarily due to the incremental $20 million funding of Term Loan B in December 2022. The $1.4 million
of interest expense includes $0.5 million of non-cash interest expense.
Interest
expense for the nine months ended September 30, 2023 was $3.9 million and represents an increase of $2.5 million, or 175%, compared to
the same period in 2022. The increase is primarily due to the incremental $20 million funding of Term Loan B in December 2022. The $3.9
million of interest expense includes $1.5 million of non-cash interest expense.
Interest
Income
Interest
income for the three months ended September 30, 2023 was $1.9 million and represents an increase of $1.6 million compared to the same
period in 2022. The increase was primarily the result of the closing of financing activities, leading to higher cash, cash equivalents
and short-term investment balances. The $1.9 million of interest income includes $0.5 million of non-cash interest income.
Interest
income for the nine months ended September 30, 2023 was $5.5 million and represents an increase of $5.1 million compared to the same
period in 2022. The increase was primarily due to the closing of financing activities, leading to higher cash, cash equivalents and short-term
investment balances. The $5.5 million of interest income includes $0.4 million of non-cash interest income.
Liquidity
and Capital Resources
Since
our inception, we have incurred losses and cumulative negative cash flows from operations. Through September 30, 2023, we have funded
our operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes,
and borrowings under loan agreements. From inception through September 30, 2023, we raised an aggregate of approximately $223.7 million
of net proceeds through sales of our securities, and as of September 30, 2023 had $35.0 million of borrowings under loan agreements.
As of September 30, 2023, our cash and cash equivalents and short-term investments were approximately $25.8 million and $108.2 million,
respectively, and we had an accumulated deficit of approximately $141.2 million.
Private
Placement. On December 9, 2022, we issued 6,182,574 shares of common stock, 1,120,873 shares of Series A Preferred Stock and warrants
exercisable for 6,956,450 shares of common stock to certain institutional and other accredited investors pursuant to a securities purchase
agreement entered into on May 15, 2022. Pursuant to the securities purchase agreement, the closing (funding) of the private placement
occurred following dosage of the first patient in the Company’s Phase 3 study, VIKTORIA-1. Investors purchased shares of common
stock and Series A Preferred Stock at a price of $5.75 per share (on an as converted to common stock basis), with forty percent (40%)
warrant coverage (on an as converted to common stock basis) and customary resale registration rights. The warrants have an exercise price
of $8.05 per share. The private placement generated gross proceeds of approximately $100 million before deducting placement agent fees
and other offering expenses of $4.3 million.
Open
Market Sale AgreementSM. On February 4, 2022, we entered into an Open Market Sale AgreementSM with Jefferies
LLC, as agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate
offering price of up to $50,000,000. On October 12, 2022, pursuant to this agreement, the Company sold 500,000 shares of common stock
in a single transaction at a price of $10.35 per share, generating gross proceeds of $5.2 million ($4.8 million net of commissions and
offering expenses). At September 30, 2023, $44.8 million of common stock remains available for sale under the Jefferies agreement.
Innovatus
Loan Agreement. On April 8, 2021, we entered into a Loan Agreement with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”),
under which Innovatus agreed to loan up to $25 million in three tranches consisting of (i) a $15.0 million non-contingent Term A loan
that was funded on April 8, 2021, (ii) a $5 million Term B loan with a deadline of March 31, 2022, and (iii) a $5 million Term C loan
to be funded upon our request, subject to our ability to achieve certain milestones, no later than March 31, 2023. On August 9, 2022,
the Company amended the Loan Agreement with Innovatus to provide for up to $75 million in term loans. As of September 30, 2023, term
loans totaling $35 million are outstanding under the Loan Agreement, including the initial Term A loan of $15 million which was funded
on April 8, 2021, and a $20 million Term B loan which was funded on December 22, 2022 following the closing of the $100 million private
placement described above. Additionally, the Company will be able to draw on two additional tranches of $10 million and one additional
tranche of $20 million upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined
on a pro forma as-funded basis. Funding of these additional tranches is also subject to other customary conditions and limits on when
the Company can request funding for such tranches.
Pre-Funded
Warrants. On October 20, 2023, we issued pre-funded warrants (the “Warrants”) to purchase 5,747,787 shares of common
stock in a private placement to certain institutional investors, pursuant to a securities purchase agreement entered into on October
18, 2023. Each Warrant to purchase one share was sold at a purchase price of $8.699 per share and has an exercise price of $0.001 per
share for the common stock issuable upon exercise of the Warrants (for aggregate consideration equating to $8.70 per share of common
stock). The sale of the Warrants pursuant to the securities purchase agreement generated gross proceeds of approximately $50 million
before deducting offering expenses payable by the Company. Please see “Management’s Discussion and Analysis of Financial
Condition and Results of Operations – Recent Developments” above for additional details.
We
expect that our research and development and general and administrative expenses will increase as we continue to develop gedatolisib,
manage the VIKTORIA-1 Phase 3 trial, initiate the CELC-G-201 trial, conduct research related to the discovery of new cancer sub-types,
conduct other studies and clinical trials, and pursue other business development activities. We would also expect to incur sales and
marketing expenses as we commercialize gedatolisib and our CELsignia tests. We expect to use cash on hand, which includes funds received
under the debt and equity financings described above, to fund our research and development expenses, clinical trial costs, capital expenditures,
working capital, sales and marketing expenses, and general corporate expenses.
Based
on our current business plan, we believe that our current cash, cash equivalents and short-term investments, together with available
borrowings under the Innovatus Loan Agreement, will provide sufficient cash to finance our operations and pay obligations when due for
at least the next twelve months.
Our
expectations as to how long our current capital resources will be sufficient to fund our operations are based on assumptions that may
not be accurate, and we could use our current capital resources sooner than we currently expect. In addition, we may seek to raise additional
capital to finance capital expenditures and operating expenses over the next several years as we launch our integrated therapeutic and
companion diagnostic strategy and expand our infrastructure, commercial operations and research and development activities, and to take
advantage of financing or other opportunities that we believe to be in the best interests of the Company and our stockholders. Additional
capital may be raised through the sale of common or preferred equity or convertible debt securities, entry into debt facilities or other
third-party funding arrangements. The sale of equity and convertible debt securities may result in dilution to our stockholders and those
securities may have rights senior to those of our common shares. Agreements entered into in connection with such capital raising activities
could contain covenants that would restrict our operations or require us to relinquish certain rights. Additional capital may not be
available on reasonable terms, or not at all.
Cash
Flows
The
following table sets forth the primary sources and uses of cash for the nine months ended September 30:
| |
September 30, | |
| |
2023 | | |
2022 | |
| |
| |
Net cash provided by (used in): | |
| | | |
| | |
Operating activities | |
$ | (35,276,332 | ) | |
$ | (26,528,911 | ) |
Investing activities | |
| 36,209,923 | | |
| (46,724 | ) |
Financing activities | |
| 254,739 | | |
| (226,970 | ) |
Net increase (decrease) in cash and cash equivalents | |
$ | 1,188,330 | | |
$ | (26,802,605 | ) |
Operating
Activities
Net
cash used in operating activities was approximately $35.3 million for the nine months ended September 30, 2023 and consisted primarily
of a net loss of approximately $44.9 million offset by non-cash expense items of approximately $4.8 million and working capital
changes of $4.8 million. Non-cash expense items of approximately $4.8 million primarily consisted of $3.7 million of stock-based compensation
expense, net non-cash interest of $1.0 million, and depreciation expense of $0.1 million. The approximately $4.8 million of working capital
changes was primarily due to increases in accounts payable and accrued expenses of $3.0 million and $2.8 million, respectively, offset
by an approximately $1.0 million increase in other current assets.
Net
cash used in operating activities was approximately $26.5 million for the nine months ended September 30, 2022 and consisted primarily
of a net loss of approximately $28.8 million and working capital changes of approximately $2.0 million, offset by non-cash expense
items of approximately $4.3 million. The approximately $2.0 million of working capital changes was primarily due to an increase of approximately
$5.9 million in other current assets, partially offset by increases in accounts payable and accrued expenses of approximately $1.6 million
and $2.3 million, respectively. Non-cash expense items of approximately $4.3 million primarily consisted of approximately $3.5 million
of stock-based compensation expense, non-cash interest expense of approximately $0.6 million and depreciation expense of approximately
$0.2 million.
Investing
Activities
Net
cash provided by investing activities for the nine months ended September 30, 2023 was approximately $36.2 million and consisted primarily
of net proceeds from maturities of short-term investments in government securities (U.S. Treasury Bills and U.S. government securities)
partially offset by minimal purchase of property and equipment. Net cash used in investing for the nine months ended September 30, 2022
were minimal and consisted of purchases of property and equipment.
Financing
Activities
Net
cash provided by financing activities for the nine months ended September 30, 2023 was approximately $0.3 million and primarily consisted
of proceeds from the exercise of employee stock options and proceeds from employee stock purchases, partially offset by payments for
secondary registration and debt issuance costs. Net cash used in financing activities was $0.2 million for the nine months ended September
30, 2022 and consisted of payments for secondary registration costs, offset partially by proceeds from the exercise of employee stock
options and proceeds from employee stock purchases.
Recent
Accounting Pronouncements
From
time-to-time new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies and
adopted by us as of the specified effective date. Unless otherwise discussed in Note 2 to our unaudited condensed financial statements
included in Item 1 of Part I of this Quarterly Report, we believe that the impact of recently issued standards that are not yet effective
will not have a material impact on our financial position or results of operations upon adoption.
Critical
Accounting Policies and Use of Estimates
Our
management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed financial
statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make
estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities
at the date of the financial statements, as well as the reported expenses during the reporting periods. These items are monitored and
analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our
estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; the results of
which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other
sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ
materially from these estimates.
Our
significant accounting policies are more fully described in Note 2 to our unaudited condensed financial statements included in Item 1
of Part I of this Quarterly Report.
Private
Securities Litigation Reform Act
The
Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Such forward-looking
information is included in this Quarterly Report and in other materials filed or to be filed by us with the SEC (as well as information
included in oral statements or other written statements made or to be made by us). Forward-looking statements include all statements
based on future expectations. This Quarterly Report contains forward-looking statements that involve risks and uncertainties including,
but not limited to, (i) our clinical trial plans and the estimated costs for such trials, including our ongoing VIKTORIA-1 Phase 3 clinical
trial and our expected Phase 1b/2 study and clinical trial for gedatolisib; (ii) our expectations with respect to costs and timelines
to develop, validate and launch CELsignia tests and to continue to develop gedatolisib; (iii) our beliefs related to the perceived advantages
of our CELsignia tests compared to traditional molecular or other diagnostic tests; (iv) the expected benefits of gedatolisib; (v) our
expectations regarding the timeline of patient enrollment and results from clinical trials, including our existing and upcoming clinical
trials for gedatolisib; (vi) the future payments that may be owned to Pfizer under the license agreement; (vii) our expectations regarding
partnering with pharmaceutical companies and other third parties; (viii) our expectations regarding revenue from sales of CELsignia tests
and revenue from milestone or other payment sources; (ix) our plans with respect to research and development and related expenses for
the foreseeable future; (x) our expectations regarding business development activities, including companion diagnostic related activities
with pharmaceutical companies, expanding our sales and marketing functions and the costs associated with such activities; (xi) our expectations
with respect to the CELsignia tests and the analytical capabilities and potential impact of such tests; (xii) our beliefs regarding the
ability of our cash on hand to fund our research and development expenses, capital expenditures, working capital, sales and marketing
expenses, and general corporate expenses, as well as the increased costs associated with being a public company; (xiii) our plans with
respect to potentially raising capital, and (xiv) our expectations regarding the impact that the COVID-19 pandemic and related economic
effects will have on our business and results of operations.
In
some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “seek,” “may,” “ongoing,”
“plan,” “goal,” “potential,” “predict,” “project,” “should,”
“will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking
statements contain these words. Forward-looking statements are only predictions and are not guarantees of performance. These statements
are based on our management’s beliefs and assumptions, which in turn are based on their interpretation of currently available information.
These
statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s actual
results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these
forward-looking statements. Certain risks, uncertainties and other factors include, but are not limited to, our limited operating history;
the potential impact of the COVID-19 pandemic on our business; our initial success being heavily dependent on the success of our CELsignia
HER2 Pathway Activity Test and of gedatolisib; our inability to develop and commercialize gedatolisib; our inability to determine whether
our CELsignia tests are currently commercially viable; challenges we may face in developing and maintaining relationships with pharmaceutical
company partners; the complexity and timeline for development of CELsignia tests and gedatolisib; the uncertainty and costs associated
with clinical trials; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical
community, and regarding the size of market opportunities available to us; the pricing of molecular and other diagnostic products and
services that compete with us; uncertainty with insurance coverage and reimbursement for our products; difficulties
we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel; changes
in government regulations; tightening credit markets, higher interest rates, and limitations on access to capital; increasingly sophisticated
cybersecurity threats, obtaining and maintaining intellectual property protection for our technology and time and expense associated
with defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against
us. These and additional risks, uncertainties and other factors are described more fully in our Annual Report on Form 10-K for
the year ended December 31, 2022 and elsewhere in this Quarterly Report. Copies of filings made with the SEC are available through the
SEC’s electronic data gathering analysis and retrieval system (EDGAR) at www.sec.gov.
You
should read the cautionary statements made in this Quarterly Report as being applicable to all related forward-looking statements wherever
they appear in this Quarterly Report. We cannot assure you that the forward-looking statements in this Quarterly Report will prove to
be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should read this
Quarterly Report completely. Other than as required by law, we undertake no obligation to update these forward-looking statements, even
though our situation may change in the future.
ITEM
3. Quantitative and Qualitative Disclosures about Market Risk
As
a smaller reporting company, we are not required to provide disclosure pursuant to this item.
ITEM
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
Chief Executive Officer and Chief Financial Officer, referred to collectively herein as the Certifying Officers, are responsible for
establishing and maintaining our disclosure controls and procedures. The Certifying Officers have reviewed and evaluated the effectiveness
of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act
of 1934, as amended (the “Exchange Act”)) as of September 30, 2023. Based on that review and evaluation, the Certifying Officers
have concluded that, as of the end of the period covered by this Quarterly Report, our disclosure controls and procedures, as designed
and implemented, are effective and provide reasonable assurance that information required to be disclosed by us in the periodic and current
reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the periods specified by
the SEC’s rules and forms.
Changes
in Internal Control Over Financial Reporting.
There
were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
during the three months ended September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
PART
II. — OTHER INFORMATION
ITEM
1. Legal Proceedings
From
time to time, we may be involved in disputes or litigation relating to claims arising out of our operations. We are not currently a party
to any legal proceedings that could reasonably be expected to have a material adverse effect on our business, financial condition and
results of operations.
ITEM
1A. Risk Factors
As
a smaller reporting company, we are not required to provide disclosure pursuant to this item. However, in addition to other information
set forth in this Quarterly Report, including the important information in the section entitled “Private Securities Litigation
Reform Act,” you should carefully consider the “Risk Factors” discussed in our Annual Report on Form 10-K for the period
ended December 31, 2022, for a discussion of important factors that could cause actual results to differ materially from the results
described in or implied by the forward-looking statements contained in this Quarterly Report. Additional risks and uncertainties not
currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition
and/or operating results.
ITEM
2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent
Unregistered Sales of Equity Securities
None.
ITEM
3. Defaults Upon Senior Securities
None.
ITEM
4. Mine Safety Disclosures
None.
ITEM
5. Other Information
None.
ITEM
6. Exhibits
EXHIBIT
INDEX
Exhibit No. |
|
Description |
|
|
|
3.1 |
|
Certificate of Incorporation of the Company, as amended, including the Certifications of Designations of Preferences, Rights, and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Annual Report on Form 10-K/A filed with the SEC on April 7, 2023). |
|
|
|
3.2 |
|
Bylaws, incorporated by reference from Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2017. |
|
|
|
4.1 |
|
Specimen Certificate representing shares of common stock of Celcuity Inc., (incorporated by reference from Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A filed September 12, 2017). |
|
|
|
4.2 |
|
Form of Warrant to Purchase Units of Membership Interest issued by Celcuity LLC to Cedar Point Capital, LLC, as placement agent of membership units and unsecured convertible promissory notes of Celcuity LLC (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017). |
|
|
|
4.3 |
|
Form of Warrant to Purchase Shares of Common Stock issued by Celcuity Inc. in connection with the conversion of 1.25% Unsecured Convertible Promissory Notes (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on September 25, 2017). |
|
|
|
4.4 |
|
Representative’s Warrant to Purchase Common Stock (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 25, 2017). |
|
|
|
4.5 |
|
First Amendment to Representative’s Warrant, dated September 13, 2022, between Celcuity Inc. and Craig-Hallum Capital Group LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 14, 2022). |
|
|
|
4.6 |
|
Form of Warrant issued by Celcuity Inc. to Innovatus Life Sciences Lending Fund I, LP in connection with the Loan and Security Agreement dated April 8, 2021(incorporated by reference from Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2021). |
|
|
|
4.7 |
|
Equity Grant Agreement, dated April 8, 2021, between the Company and Pfizer, Inc., (incorporated by reference from Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2021). |
|
|
|
4.8 |
|
Form of Warrant issued by Celcuity Inc. in connection with the Securities Purchase Agreement, dated May 15, 2022 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2022). |
|
|
|
4.9 |
|
Form of Pre-Funded Warrant issued by Celcuity Inc. in connection with the Securities Purchase Agreement, dated October 18, 2023 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 23, 2023). |
|
|
|
10.1 |
|
Securities Purchase Agreement, dated October 18, 2023, by and among the Company and the Investors named therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 23, 2023). |
|
|
|
10.2 |
|
Registration Rights Agreement, dated October 18, 2023, by and among the Company and the Investors named therein (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on October 23, 2023). |
|
|
|
31.1* |
|
Certification of Chairman and Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2* |
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1** |
|
Certification of Chairman and Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2** |
|
Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101* |
|
Financial statements from the Quarterly Report on Form
10-Q of the Company for the quarter ended September 30, 2023, formatted in Inline XBRL: (i) the Condensed Balance Sheets, (ii) the
Condensed Statements of Operations, (iii) the Condensed Statements of Changes in Stockholders’ Equity, (iv) the Condensed Statements
of Cash Flows, and (v) the Notes to Condensed Financial Statements. |
|
|
|
104* |
|
Cover Page Interactive Data File (formatted as Inline
XBRL and contained in Exhibit 101) |
* | Filed
herewith. |
** | Furnished
herewith. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by
the undersigned thereunto duly authorized.
Dated:
November 13, 2023 |
CELCUITY
INC. |
|
|
|
|
By |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan |
|
|
Chairman
and Chief Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
|
By |
/s/
Vicky Hahne |
|
|
Vicky
Hahne |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
Exhibit
31.1
CERTIFICATION
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Brian F. Sullivan, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Celcuity Inc. (the “registrant”); |
|
|
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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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 (or persons performing
the equivalent functions): |
|
(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. |
Dated:
November 13, 2023 |
By |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan |
|
|
Chairman
and Chief Executive Officer |
Exhibit
31.2
CERTIFICATION
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Vicky Hahne, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Celcuity Inc. (the “registrant”); |
|
|
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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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 (or persons performing
the equivalent functions): |
|
(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. |
Dated:
November 13, 2023 |
By |
/s/
Vicky Hahne |
|
|
Vicky
Hahne |
|
|
Chief
Financial Officer |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT
TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the filing of the Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 (the “Report”) by
Celcuity Inc. (“Registrant”), I, Brian F. Sullivan, the Chief Executive Officer of the Registrant, certify, pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that to the best of my knowledge:
|
1. |
The Report fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
2. |
The information contained in the Report fairly presents, in
all material respects, the financial condition and results of operations of the Registrant. |
Dated:
November 13, 2023 |
By |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan |
|
|
Chairman
and Chief Executive Officer |
Exhibit
32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT
TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the filing of the Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 (the “Report”) by
Celcuity Inc. (“Registrant”), I, Vicky Hahne, the Chief Financial Officer of the Registrant, certify, pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that to the best of my knowledge:
|
1. |
The Report fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
2. |
The information contained in the Report fairly presents, in
all material respects, the financial condition and results of operations of the Registrant. |
Dated:
November 13, 2023 |
By |
/s/
Vicky Hahne |
|
|
Vicky
Hahne |
|
|
Chief
Financial Officer |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 06, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-38207
|
|
Entity Registrant Name |
CELCUITY
INC.
|
|
Entity Central Index Key |
0001603454
|
|
Entity Tax Identification Number |
82-2863566
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
16305
36th Avenue North; Suite 100
|
|
Entity Address, City or Town |
Minneapolis
|
|
Entity Address, State or Province |
MN
|
|
Entity Address, Postal Zip Code |
55446
|
|
City Area Code |
(763)
|
|
Local Phone Number |
392-0767
|
|
Title of 12(b) Security |
Common
Stock, $0.001 par value per share
|
|
Trading Symbol |
CELC
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
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24,203,156
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v3.23.3
Condensed Balance Sheets - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Current Assets: |
|
|
Cash and cash equivalents |
$ 25,759,887
|
$ 24,571,557
|
Investments |
108,180,417
|
144,015,954
|
Other current assets |
7,771,131
|
6,603,026
|
Total current assets |
141,711,435
|
175,190,537
|
Property and equipment, net |
223,378
|
260,294
|
Operating lease right-of-use assets |
449,368
|
246,266
|
Total Assets |
142,384,181
|
175,697,097
|
Current Liabilities: |
|
|
Accounts payable |
5,634,806
|
2,627,076
|
Finance lease liabilities |
|
2,449
|
Operating lease liabilities |
188,100
|
191,749
|
Accrued expenses |
6,887,136
|
4,060,280
|
Total current liabilities |
12,710,042
|
6,881,554
|
Operating lease liabilities |
270,925
|
61,002
|
Note payable, non-current |
36,506,774
|
34,983,074
|
Total Liabilities |
49,487,741
|
41,925,630
|
Commitments and Contingencies (Note 5) |
|
|
Stockholders’ Equity: |
|
|
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 1,060,873 and 1,120,873 shares issued and outstanding as of September 30, 2023 and December 31, 2022 |
1,061
|
1,121
|
Common stock, $0.001 par value: 65,000,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively; 22,369,393 and 21,667,250 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
22,369
|
21,667
|
Additional paid-in capital |
234,100,541
|
230,045,566
|
Accumulated deficit |
(141,227,531)
|
(96,296,887)
|
Total Stockholders’ Equity |
92,896,440
|
133,771,467
|
Total Liabilities and Stockholders’ Equity |
$ 142,384,181
|
$ 175,697,097
|
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v3.23.3
Condensed Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
2,500,000
|
2,500,000
|
Preferred stock, shares issued |
1,060,873
|
1,120,873
|
Preferred stock, shares outstanding |
1,060,873
|
1,120,873
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
65,000,000
|
65,000,000
|
Common stock, shares issued |
22,369,393
|
21,667,250
|
Common stock, shares outstanding |
22,369,393
|
21,667,250
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating expenses: |
|
|
|
|
Research and development |
$ 17,488,236
|
$ 9,621,505
|
$ 42,512,811
|
$ 24,685,505
|
General and administrative |
1,409,801
|
1,022,050
|
3,988,248
|
3,066,382
|
Total operating expenses |
18,898,037
|
10,643,555
|
46,501,059
|
27,751,887
|
Loss from operations |
(18,898,037)
|
(10,643,555)
|
(46,501,059)
|
(27,751,887)
|
Other income (expense) |
|
|
|
|
Interest expense |
(1,372,132)
|
(537,661)
|
(3,929,140)
|
(1,428,108)
|
Interest income |
1,865,629
|
287,495
|
5,499,555
|
391,301
|
Other income (expense), net |
493,497
|
(250,166)
|
1,570,415
|
(1,036,807)
|
Net loss before income taxes |
(18,404,540)
|
(10,893,721)
|
(44,930,644)
|
(28,788,694)
|
Income tax benefits |
|
|
|
|
Net loss |
$ (18,404,540)
|
$ (10,893,721)
|
$ (44,930,644)
|
$ (28,788,694)
|
Net loss per share, basic |
$ (0.83)
|
$ (0.75)
|
$ (2.05)
|
$ (1.95)
|
Net loss per share, diluted |
$ (0.83)
|
$ (0.75)
|
$ (2.05)
|
$ (1.95)
|
Weighted average common shares outstanding, basic |
22,117,626
|
14,938,224
|
21,920,147
|
14,928,727
|
Weighted average common shares outstanding, diluted |
22,117,626
|
14,938,224
|
21,920,147
|
14,928,727
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.3
Condensed Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Preferred Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 14,919
|
|
$ 124,622,405
|
$ (55,926,847)
|
$ 68,710,477
|
Beginning balance, shares at Dec. 31, 2021 |
14,918,887
|
|
|
|
|
Stock-based compensation |
|
|
756,271
|
|
756,271
|
Exercise of common stock options, net of shares withheld for exercise price |
$ 1
|
|
7,413
|
|
7,414
|
Exercise of common stock options, net of shares withheld for exercise price, shares |
1,415
|
|
|
|
|
Net loss |
|
|
|
(7,934,447)
|
(7,934,447)
|
Ending balance, value at Mar. 31, 2022 |
$ 14,920
|
|
125,386,089
|
(63,861,294)
|
61,539,715
|
Ending balance, shares at Mar. 31, 2022 |
14,920,302
|
|
|
|
|
Beginning balance, value at Dec. 31, 2021 |
$ 14,919
|
|
124,622,405
|
(55,926,847)
|
68,710,477
|
Beginning balance, shares at Dec. 31, 2021 |
14,918,887
|
|
|
|
|
Net loss |
|
|
|
|
(28,788,694)
|
Ending balance, value at Sep. 30, 2022 |
$ 14,943
|
|
128,225,939
|
(84,715,541)
|
43,525,341
|
Ending balance, shares at Sep. 30, 2022 |
14,942,958
|
|
|
|
|
Beginning balance, value at Mar. 31, 2022 |
$ 14,920
|
|
125,386,089
|
(63,861,294)
|
61,539,715
|
Beginning balance, shares at Mar. 31, 2022 |
14,920,302
|
|
|
|
|
Stock-based compensation |
$ 3
|
|
1,519,456
|
|
1,519,459
|
Stock-based compensation, shares |
3,273
|
|
|
|
|
Exercise of common stock options, net of shares withheld for exercise price |
$ 2
|
|
9,540
|
|
9,542
|
Exercise of common stock options, net of shares withheld for exercise price, shares |
1,871
|
|
|
|
|
Net loss |
|
|
|
(9,960,526)
|
(9,960,526)
|
Employee stock purchases |
$ 16
|
|
80,525
|
|
80,541
|
Employee stock purchases, shares |
15,888
|
|
|
|
|
Ending balance, value at Jun. 30, 2022 |
$ 14,941
|
|
126,995,610
|
(73,821,820)
|
53,188,731
|
Ending balance, shares at Jun. 30, 2022 |
14,941,334
|
|
|
|
|
Stock-based compensation |
|
|
1,223,054
|
|
1,223,054
|
Stock-based compensation, shares |
250
|
|
|
|
|
Exercise of common stock options, net of shares withheld for exercise price |
$ 2
|
|
7,275
|
|
7,277
|
Exercise of common stock options, net of shares withheld for exercise price, shares |
1,374
|
|
|
|
|
Net loss |
|
|
|
(10,893,721)
|
(10,893,721)
|
Ending balance, value at Sep. 30, 2022 |
$ 14,943
|
|
128,225,939
|
(84,715,541)
|
43,525,341
|
Ending balance, shares at Sep. 30, 2022 |
14,942,958
|
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 21,667
|
$ 1,121
|
230,045,566
|
(96,296,887)
|
133,771,467
|
Beginning balance, shares at Dec. 31, 2022 |
21,667,250
|
1,120,873
|
|
|
|
Stock-based compensation |
|
|
1,273,282
|
|
1,273,282
|
Stock-based compensation, shares |
|
|
|
|
|
Exercise of common stock options, net of shares withheld for exercise price |
$ 24
|
|
127,898
|
|
127,922
|
Exercise of common stock options, net of shares withheld for exercise price, shares |
24,122
|
|
|
|
|
Conversion of preferred to common stock |
$ 250
|
$ (25)
|
(225)
|
|
|
Conversion of preferred to common stock, shares |
250,000
|
(25,000)
|
|
|
|
Issuance costs associated with private placement offering |
|
|
(7,486)
|
|
(7,486)
|
Net loss |
|
|
|
(11,938,417)
|
(11,938,417)
|
Ending balance, value at Mar. 31, 2023 |
$ 21,941
|
$ 1,096
|
231,439,035
|
(108,235,304)
|
123,226,768
|
Ending balance, shares at Mar. 31, 2023 |
21,941,372
|
1,095,873
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 21,667
|
$ 1,121
|
230,045,566
|
(96,296,887)
|
133,771,467
|
Beginning balance, shares at Dec. 31, 2022 |
21,667,250
|
1,120,873
|
|
|
|
Net loss |
|
|
|
|
(44,930,644)
|
Ending balance, value at Sep. 30, 2023 |
$ 22,369
|
$ 1,061
|
234,100,541
|
(141,227,531)
|
92,896,440
|
Ending balance, shares at Sep. 30, 2023 |
22,369,393
|
1,060,873
|
|
|
|
Beginning balance, value at Mar. 31, 2023 |
$ 21,941
|
$ 1,096
|
231,439,035
|
(108,235,304)
|
123,226,768
|
Beginning balance, shares at Mar. 31, 2023 |
21,941,372
|
1,095,873
|
|
|
|
Stock-based compensation |
$ 2
|
|
1,276,980
|
|
1,276,982
|
Stock-based compensation, shares |
1,958
|
|
|
|
|
Exercise of common stock options, net of shares withheld for exercise price |
$ 22
|
|
113,618
|
|
113,640
|
Exercise of common stock options, net of shares withheld for exercise price, shares |
21,086
|
|
|
|
|
Conversion of preferred to common stock |
$ 100
|
$ (10)
|
(90)
|
|
|
Conversion of preferred to common stock, shares |
100,000
|
(10,000)
|
|
|
|
Net loss |
|
|
|
(14,587,687)
|
(14,587,687)
|
Employee stock purchases |
$ 17
|
|
102,621
|
|
102,638
|
Employee stock purchases, shares |
17,477
|
|
|
|
|
Ending balance, value at Jun. 30, 2023 |
$ 22,082
|
$ 1,086
|
232,932,164
|
(122,822,991)
|
110,132,341
|
Ending balance, shares at Jun. 30, 2023 |
22,081,893
|
1,085,873
|
|
|
|
Stock-based compensation |
|
|
1,108,637
|
|
1,108,637
|
Exercise of common stock options, net of shares withheld for exercise price |
$ 37
|
|
59,965
|
|
60,002
|
Exercise of common stock options, net of shares withheld for exercise price, shares |
37,500
|
|
|
|
|
Conversion of preferred to common stock |
$ 250
|
$ (25)
|
(225)
|
|
|
Conversion of preferred to common stock, shares |
250,000
|
(25,000)
|
|
|
|
Net loss |
|
|
|
(18,404,540)
|
(18,404,540)
|
Ending balance, value at Sep. 30, 2023 |
$ 22,369
|
$ 1,061
|
$ 234,100,541
|
$ (141,227,531)
|
$ 92,896,440
|
Ending balance, shares at Sep. 30, 2023 |
22,369,393
|
1,060,873
|
|
|
|
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v3.23.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (44,930,644)
|
$ (28,788,694)
|
Adjustments to reconcile net loss to net cash used for operations: |
|
|
Depreciation |
114,824
|
161,981
|
Stock-based compensation |
3,658,902
|
3,498,784
|
Amortization of debt issuance costs and discount |
177,939
|
284,184
|
Payment-in-Kind interest |
1,345,760
|
311,764
|
Non-cash operating lease, net |
3,171
|
(2,791)
|
Change in accrued interest income |
(439,331)
|
|
Changes in operating assets and liabilities: |
|
|
Other current assets |
(1,065,732)
|
(5,817,737)
|
Accounts payable |
3,031,923
|
1,553,176
|
Accrued expenses |
2,826,856
|
2,270,422
|
Net cash used for operating activities |
(35,276,332)
|
(26,528,911)
|
Cash flows from investing activities: |
|
|
Proceeds from maturities of investments |
221,054,402
|
|
Purchases of investments |
(184,779,534)
|
|
Purchases of property and equipment |
(64,945)
|
(46,724)
|
Net cash provided by (used for) investing activities |
36,209,923
|
(46,724)
|
Cash flows from financing activities: |
|
|
Proceeds from exercise of employee stock options |
285,564
|
24,233
|
Proceeds from employee stock purchases |
102,638
|
80,541
|
Payments for secondary registration statement costs |
(128,298)
|
(318,897)
|
Payments for debt issuance costs |
(2,716)
|
(8,463)
|
Payments for finance leases |
(2,449)
|
(4,384)
|
Net cash provided by (used for) financing activities |
254,739
|
(226,970)
|
Net change in cash and cash equivalents |
1,188,330
|
(26,802,605)
|
Cash and cash equivalents: |
|
|
Beginning of period |
24,571,557
|
84,286,381
|
End of period |
25,759,887
|
57,483,776
|
Supplemental disclosure of cash flow information: |
|
|
Interest paid |
2,405,441
|
832,161
|
Supplemental disclosures of non-cash investing and financing activities: |
|
|
Offering and registration statement costs included in accounts payable |
13,865
|
11,230
|
Deferred financing costs and offering and registration statement costs included in accrued expenses |
|
205,000
|
Property and equipment included in accounts payable |
$ 12,961
|
$ 104,818
|
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v3.23.3
Organization
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization |
1.
Organization
Nature
of Business
Celcuity
Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company pursuing development for oncology.
The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic
properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.
A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients
with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib
in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is expected to be initiated in the
first quarter of 2024. The company’s CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells
to identify new groups of cancer patients likely to benefit from already approved targeted therapies. The Company was co-founded in 2012
by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company has not generated any revenues to date.
|
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v3.23.3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements |
2.
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
Basis
of Presentation
The
accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10
of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article 10,
the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the
United States (“U.S. GAAP”). The balance sheet at December 31, 2022 was derived from the audited financial statements at
that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of
a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed
financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2022
and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Operating
results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected during the
remainder of the current year or for any future period.
Accounting
Estimates
Management
uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S. GAAP. Those estimates
and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported
revenues and expenses. Actual results could differ from those estimates and the difference could be material. Significant items subject
to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.
Risks
and Uncertainties
The
Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and
commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests and initial drug product, gedatolisib,
the clinical and commercial success of gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of
broad adoption of its approved products, if any, by physicians and consumers, and significant competition.
Clinical
Trial Costs
The
Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers,
which includes the conduct of preclinical studies and clinical trials. These costs can be a significant component of the Company’s
research and development expenses. The Company primarily relies on a compilation of progress reports from third-party service providers,
including the respective invoicing, to record actual expenses, along with determining changes to prepaid assets and accrued liabilities.
To date, the company believes utilization of third-party reports most accurately reflects expenses incurred. As the current VIKTORIA-1
Phase 3 trial ramps up site activation and patient enrollment, the Company’s estimated expenses in future periods and actual services
performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material
changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.
Recently
Adopted Accounting Pronouncements
In
June 2016 and related amendments, the FASB issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit
Losses (Topic 326). This guidance changes the methodology to be used to measure credit losses for certain financial instruments and financial
assets. The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to
be incurred over the life of the financial asset. The Company adopted this standard effective January 1, 2023. The adoption of the standard
did not have a material impact on the Company’s consolidated financial statements.
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v3.23.3
Net Loss Per Common Share
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net Loss Per Common Share |
3.
Net Loss Per Common Share
Basic
and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average
common shares outstanding during the period. For all periods presented, the common shares underlying the preferred stock, options, warrants,
and restricted stock have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average
shares outstanding used to calculate both basic and diluted loss per common share is the same.
For
the three and nine months ended September 30, 2023 and 2022, potentially dilutive securities excluded from the computations of diluted
weighted-average shares outstanding were preferred stock on an as-if-converted to common stock basis of 10,608,730 and zero shares of
common stock, respectively, options to purchase 2,702,629 and 1,919,114 shares of common stock, respectively, warrants to purchase 7,266,102
and 309,652 shares of common stock, respectively, and 1,958 and 3,273 shares of restricted common stock, respectively.
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v3.23.3
Investments
|
9 Months Ended |
Sep. 30, 2023 |
Investments, All Other Investments [Abstract] |
|
Investments |
4.
Investments
Debt
securities for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported
at historical cost adjusted for amortization of premiums and accretion of discounts. Expected credit losses, if any, are recorded through
the establishment of an allowance for credit losses. All of the Company’s held-to-maturity
investment securities are U.S. Treasury and agencies securities that are guaranteed or otherwise
supported by the United States government and have no history of credit losses. Accordingly, the Company does not expect to incur any
credit losses on held-to-maturity investment securities and has no allowance
for credit losses recorded for these securities.
The
following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of September 30, 2023 and
December 31, 2022:
Schedule of Investment
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
September 30, 2023 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
| | |
| | |
| | |
| |
U.S. Treasury Bills | |
$ | 108,180,417 | | |
$ | 5,138 | | |
$ | - | | |
$ | 108,185,555 | |
Total | |
$ | 108,180,417 | | |
$ | 5,138 | | |
$ | - | | |
$ | 108,185,555 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
December 31, 2022 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
| | |
| | |
| | |
| |
Governmental Agency Securities | |
$ | 46,230,893 | | |
$ | 29,517 | | |
$ | - | | |
$ | 46,260,410 | |
U.S. Treasury Bills | |
| 97,785,061 | | |
| 41,639 | | |
| - | | |
| 97,826,700 | |
Total | |
$ | 144,015,954 | | |
$ | 71,156 | | |
$ | - | | |
$ | 144,087,110 | |
The
fair value of the Company’s held-to-maturity debt securities is determined based upon inputs, other than the quoted prices in active
markets, that are observable either directly or indirectly and are classified as level 2 fair value instruments.
|
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v3.23.3
Commitments
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments |
5.
Commitments
Operating
Lease
The
Company leases its corporate space in Minneapolis, Minnesota, with an operating lease in place through April 30, 2026. The lease provides
for monthly rent, real estate taxes, and operating expenses. Rent expense is recorded on a straight-line basis over the lease term. In
March 2023, the Company signed the fourth amendment to extend this lease through April 30, 2026. This amendment provides for monthly
rent, real estate taxes and operating expenses. The Company recorded an incremental $355,578 in the operating right-of-use (“ROU”)
asset and lease liability pertaining to this amendment.
Clinical
Research Studies
The
Company enters into contracts in the normal course of business to conduct research and development programs internally and through third
parties that include, among others, arrangements with vendors, consultants, CMO’s, and CRO’s. The Company currently has four
Phase 2 clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia tests. Timing of milestone
payments related to the Phase 2 clinical trials are uncertain and the contracts generally provide for termination following a certain
period after notice, therefore the Company believes that non-cancelable obligations under the agreements are not material. The Company
also has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib. In conjunction with
the license agreement, the Company continued a Phase 1b study – B2151009 related to gedatolisib. These patients subsequently transitioned
to an Expanded Access study – CELC-G-001. Contracts related to the Expanded Access study, are generally based on time and material.
In addition, contracts related to the Company’s Phase 3 (VIKTORIA-1) and Phase 1b/2 (CELC-G-201) clinical trials are generally
cancelable with reasonable notice within 120 days and the Company’s obligations under these contracts are primarily based on services
performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition,
these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties. As of September
30, 2023, the Company had two material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately
$2.3 million.
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v3.23.3
Stockholders’ Equity
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
6.
Stockholders’ Equity
Capital
Stock
At
December 31, 2022, the Company’s authorized capital stock consisted of 65,000,000 shares of $.001 par value common stock, of which
21,667,250 shares were outstanding, and 2,500,000 shares of $.001 par value preferred stock, of which 1,120,873 shares were outstanding.
On
March 31, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred
Stock into 250,0000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis of
the shares transferred is $5.75 per share.
On
June 29, 2023, one of the Company’s preferred shareholders elected to convert 10,000 shares of Series A Convertible Preferred Stock
into 100,0000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis of the
shares transferred is $5.75 per share.
On
September 21, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred
Stock into 250,0000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis of
the shares transferred is $5.75 per share.
At
September 30, 2023, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 22,369,393
shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock,
of which 1,060,873 shares were outstanding. As of September 30, 2023, no dividends have been declared on the Company’s capital
stock.
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v3.23.3
Stock-Based Compensation
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-Based Compensation |
7.
Stock-Based Compensation
The
following table summarizes the activity for all stock options outstanding for the nine months ended September 30:
Schedule of Stock Options Activity
| |
2023 | | |
2022 | |
| |
Shares | | |
Weighted Average Exercise Price | | |
Shares | | |
Weighted Average Exercise Price | |
Options outstanding at beginning of year | |
| 1,976,586 | | |
$ | 6.34 | | |
| 1,315,321 | | |
$ | 11.97 | |
Granted | |
| 874,548 | | |
| 10.13 | | |
| 720,047 | | |
| 7.19 | |
Exercised | |
| (82,708 | ) | |
| 3.65 | | |
| (4,660 | ) | |
| 5.20 | |
Forfeited | |
| (65,797 | ) | |
| 7.45 | | |
| (111,594 | ) | |
| 10.86 | |
Balance at September 30 | |
| 2,702,629 | | |
$ | 7.63 | | |
| 1,919,114 | | |
$ | 6.08 | |
| |
| | | |
| | | |
| | | |
| | |
Options exercisable at September 30: | |
| 1,440,231 | | |
$ | 6.26 | | |
| 882,215 | | |
$ | 5.92 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Grant Date Fair Value for options granted during the period: | |
| | | |
$ | 7.09 | | |
| | | |
$ | 4.87 | |
The
following table summarizes additional information about stock options outstanding and exercisable at September 30, 2023:
Schedule of Stock Options Outstanding and Exercisable
Options Outstanding | |
Options Exercisable |
Options Outstanding | |
Weighted Average Remaining Contractual Life | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | | |
Options Exercisable | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
2,702,629 | |
| 8.09 | | |
$ | 7.63 | | |
$ | 5,355,467 | | |
1,440,231 | |
$ | 6.26 | | |
$ | 4,470,641 | |
The
Company recognized stock-based compensation expense for stock options of $1,065,568 and $1,162,751 for the three months ended September
30, 2023 and 2022, respectively, and $3,516,180 and $3,329,969 for the nine months ended September 30, 2023 and 2022, respectively. In
May 2022, the Company modified the exercise price on 776,324 stock option awards to $5.50, the closing market price on the Nasdaq Capital
Market on May 17, 2022. The effect of this modification on stock-based compensation was $30,188 and $49,088 for the three months ending
September 30, 2023 and 2022, respectively, and $107,490 and $477,431 for the nine months ending September 30, 2023 and 2022, respectively.
The effect of this modification on stock-based compensation over the remaining service period will be approximately $190,000. In December
2021, the Company modified the exercise price on 311,000 stock option awards to $13.44, the closing market price on the Nasdaq Capital
Market on December 15, 2021. No director or officer awards were modified. The effect of this modification on stock-based compensation
was $15,773 and $21,778 for the three months ended September 30, 2023 and 2022, respectively, and $49,617 and $75,562 for the nine months
ended September 30, 2023 and 2022, respectively. The effect of this modification on stock-based compensation over the remaining service
period will be approximately $114,000. In May 2020, the Company modified the exercise price on 203,750 stock option awards to $5.10,
the closing market price on the Nasdaq Capital Market on May 14, 2020. No director or officer awards were modified. The effect of this
modification on stock-based compensation was $3,041 and $7,681 for the three months ended September 30, 2023 and 2022, respectively,
and $16,975 and $30,897 for the nine months ended September 30, 2023 and 2022. The effect of this modification on stock-based compensation
over the remaining service period will be approximately $3,000.
The
Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions
for the nine months ended September 30:
Schedule of Assumptions for Fair Value of Equity-based Awards
| |
2023 | | |
2022 | |
Risk-free interest rate | |
| 3.41% - 4.61% | | |
| 1.68% - 3.93% | |
Expected volatility | |
| 78.0 to 79.8% | | |
| 76.2% - 79.6% | |
Expected life (years) | |
| 5.25 to 6.08 | | |
| 5.29 to 6.25 | |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
The
inputs for the Black-Scholes valuation model require management’s significant assumptions. Prior to the Company’s initial
public offering, the price per share of common stock was determined by the Company’s board based on recent prices of common stock
sold in private offerings. Subsequent to the initial public offering, the price per share of common stock is determined by using the
closing market price on the Nasdaq Capital Market on the grant date. The risk-free interest rates are based on the rate for U.S. Treasury
securities at the date of grant with maturity dates approximately equal to the expected life at the grant date. The expected life is
based on the simplified method in accordance with the SEC Staff Accounting Bulletin Nos. 107 and 110. The expected volatility is estimated
based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated
volatility since being publicly traded.
All
assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for
options granted to employees. In the event the Company terminates any of its consulting agreements, the unvested options issued in connection
with the agreements would also be cancelled.
The
Company had 1,958 and 3,273 shares of restricted stock outstanding as of September 30, 2023 and 2022, respectively, and 0 and 250 shares
of restricted stock vested during the three months ended September 30, 2023 and 2022, respectively. The Company recognized stock-based
compensation expense for restricted stock of $4,903 and $7,245 for the three months ended September 30, 2023 and 2022, respectively,
and $13,597 and $36,686 for the nine months ended September 30, 2023 and 2022, respectively.
The
Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Amended and Restated Stock Incentive
Plan (the “2017 Plan”). The number of shares reserved for issuance was automatically increased by 102,998, 149,189 and 216,673
shares on January 1, 2021, 2022 and 2023, respectively, and will increase automatically on January 1 of each year from 2024 through 2027
by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding
December 31, subject to the board’s discretion to reduce the amount of the increase in any particular year. At the Annual Meetings
held on May 12, 2021 and May 12, 2022, the stockholders approved a one-time, 500,000 increase each year for a total of 1,000,000 increase,
to the number of shares reserved for issuance under the 2017 Plan. At the Annual Meeting held on May 11, 2023, the stockholders approved
a one-time, 1,500,000 increase to the number of shares reserved for issuance under the 2017 plan. The total remaining shares available
for grant under the Company’s 2017 Plan as of September 30, 2023 was 1,147,899.
Total
unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows:
Schedule of Unrecognized Compensation Cost
2023 | |
$ | 1,177,419 | |
| |
| |
2023 | |
$ | 1,177,419 | |
2024 | |
| 3,679,163 | |
2025 | |
| 2,465,972 | |
2026 | |
| 1,515,642 | |
2027 | |
| 635,575 | |
Total estimated compensation cost to be recognized | |
$ | 9,473,771 | |
The
Company recognized stock-based compensation expense related to its employee stock purchase plan of $38,167 and $53,058 for the three
months ended September 30, 2023 and 2022, respectively and $129,125 and $132,129 for the nine months ended September 30, 2023 and 2022,
respectively. The Company initially reserved a total of 100,000 shares for issuance under the employee stock purchase plan. The number
of shares reserved for issuance was automatically increased by 51,499, 74,594 and 108,337 shares on January 1, 2021, 2022 and 2023, respectively,
and will increase automatically on each subsequent January 1 by the number of shares equal to 0.5% of the total outstanding number of
shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount
of the increase in any particular year. The total remaining shares available for issuance under the employee stock purchase plan as of
September 30, 2023 was 283,008.
The
Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30:
Schedule of Stock-based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Stock-based compensation expense in operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 660,706 | | |
$ | 676,524 | | |
$ | 1,954,689 | | |
$ | 1,937,707 | |
General and administrative | |
| 447,931 | | |
| 546,530 | | |
| 1,704,213 | | |
| 1,561,077 | |
Total | |
$ | 1,108,637 | | |
$ | 1,223,054 | | |
$ | 3,658,902 | | |
$ | 3,498,784 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Debt
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
Debt |
8.
Debt
On
April 8, 2021, the Company entered into a loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences
Lending Fund I, LP, a Delaware limited partnership (“Innovatus”) in its capacity as Collateral Agent and sole Lender. On
August 9, 2022, the Company amended the Loan Agreement. Under the amended Loan Agreement, Innovatus, as Lender, has agreed to loan up
to $75 million, a $50 million increase from the original Loan Amount. As of September 30, 2023, term loans totaling $35 million are outstanding
under the Loan Agreement, including the initial Term A loan of $15 million which was funded on April 8, 2021, and a $20 million Term
B loan which was funded on December 22, 2022.
Long-term
debt consisted of the following at September 30, 2023 and December 31, 2022:
Schedule of Long-term Debt
| |
September 30, 2023 | | |
December 31, 2022 | |
Note payable | |
$ | 35,000,000 | | |
$ | 35,000,000 | |
Add: PIK interest (added to principal) | |
| 2,100,835 | | |
| 755,075 | |
Less: unamortized debt issuance costs | |
| (540,392 | ) | |
| (707,001 | ) |
Less: unamortized debt discount | |
| (53,669 | ) | |
| (65,000 | ) |
Total long-term debt | |
$ | 36,506,774 | | |
$ | 34,983,074 | |
Future
principal payments, including the incurred PIK interest, are as follows:
Schedule of Long Term Debt Future Principal Payments
| |
Years
Ending December 31, | |
| |
| |
2025 | |
$ | 13,912,813 | |
2026 | |
| 18,550,418 | |
2027 | |
| 4,637,604 | |
Total | |
$ | 37,100,835 | |
|
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
9.
Subsequent Events
On
October 18, 2023, the Company entered into a securities purchase agreement with certain investors (the “Investors”) pursuant
to which the Company agreed to sell to the Investors in a private placement (the “Private Placement”) pre-funded warrants
(the “Warrants”) to purchase up to 5,747,787 shares of the Company’s common stock, par value $0.001 per share (the
“Common Stock”). Each Warrant is immediately exercisable and will not expire. Each warrant to purchase one share has a purchase
price of $8.699 per share, and an exercise price of $0.001 per share for the Common Stock issuable upon exercise of the Warrant.
The
closing of the Private Placement occurred on October 20, 2023 and resulted in gross proceeds to the Company of approximately $50 million,
before deducting offering expenses payable by the Company.
In
connection with the Private Placement, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”)
with the Investors, pursuant to which the Company has agreed to file, no later than 30 days following the Closing Date of the Private
Placement, a registration statement covering the resale by the Investors of the shares issued or issuable upon exercise or exchange of
the Warrants (as defined more specifically in the Registration Rights Agreement, the “Registrable Securities”).
In
the event that a registration statement covering the Registrable Securities is not filed with the SEC on or prior to the filing deadline
as set forth in the Registration Rights Agreement, or is not declared effective within the timeframe provided therein, or if certain
other circumstances occur, as described in the Registration Rights Agreement, that prevent the Investors from selling securities pursuant
to the registration statement, the Company has agreed to make pro rata payments to each holder as liquidated damages in an amount equal
to 1.0% of the aggregate amount paid pursuant to the Securities Purchase Agreement by such Investor for each 30-day period or pro rata
for any portion thereof for each such month during which such event continues, provided that the maximum aggregate amounts payable as
liquidated damages shall not exceed 6.0% of the aggregate amount invested by each such holder in the Registrable Securities then held
by the holder.
On
October 13, 2023, one of the Company’s preferred shareholders elected to convert 181,739 shares of Series A Convertible Preferred
Stock into 1,817,390 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022. The cost basis
of the shares transferred is $5.75 per share.
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v3.23.3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10
of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article 10,
the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the
United States (“U.S. GAAP”). The balance sheet at December 31, 2022 was derived from the audited financial statements at
that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of
a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed
financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2022
and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Operating
results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected during the
remainder of the current year or for any future period.
|
Accounting Estimates |
Accounting
Estimates
Management
uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S. GAAP. Those estimates
and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported
revenues and expenses. Actual results could differ from those estimates and the difference could be material. Significant items subject
to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.
|
Risks and Uncertainties |
Risks
and Uncertainties
The
Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and
commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests and initial drug product, gedatolisib,
the clinical and commercial success of gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of
broad adoption of its approved products, if any, by physicians and consumers, and significant competition.
|
Clinical Trial Costs |
Clinical
Trial Costs
The
Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers,
which includes the conduct of preclinical studies and clinical trials. These costs can be a significant component of the Company’s
research and development expenses. The Company primarily relies on a compilation of progress reports from third-party service providers,
including the respective invoicing, to record actual expenses, along with determining changes to prepaid assets and accrued liabilities.
To date, the company believes utilization of third-party reports most accurately reflects expenses incurred. As the current VIKTORIA-1
Phase 3 trial ramps up site activation and patient enrollment, the Company’s estimated expenses in future periods and actual services
performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material
changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
In
June 2016 and related amendments, the FASB issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit
Losses (Topic 326). This guidance changes the methodology to be used to measure credit losses for certain financial instruments and financial
assets. The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to
be incurred over the life of the financial asset. The Company adopted this standard effective January 1, 2023. The adoption of the standard
did not have a material impact on the Company’s consolidated financial statements.
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v3.23.3
Investments (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Investments, All Other Investments [Abstract] |
|
Schedule of Investment |
The
following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of September 30, 2023 and
December 31, 2022:
Schedule of Investment
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
September 30, 2023 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
| | |
| | |
| | |
| |
U.S. Treasury Bills | |
$ | 108,180,417 | | |
$ | 5,138 | | |
$ | - | | |
$ | 108,185,555 | |
Total | |
$ | 108,180,417 | | |
$ | 5,138 | | |
$ | - | | |
$ | 108,185,555 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
December 31, 2022 | |
| |
Amortized Cost, as Adjusted | | |
Gross Unrealized Holding Gains | | |
Gross Unrealized Holding Losses | | |
Estimated Fair Value | |
| |
| | |
| | |
| | |
| |
Governmental Agency Securities | |
$ | 46,230,893 | | |
$ | 29,517 | | |
$ | - | | |
$ | 46,260,410 | |
U.S. Treasury Bills | |
| 97,785,061 | | |
| 41,639 | | |
| - | | |
| 97,826,700 | |
Total | |
$ | 144,015,954 | | |
$ | 71,156 | | |
$ | - | | |
$ | 144,087,110 | |
|
X |
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v3.23.3
Stock-Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Options Activity |
The
following table summarizes the activity for all stock options outstanding for the nine months ended September 30:
Schedule of Stock Options Activity
| |
2023 | | |
2022 | |
| |
Shares | | |
Weighted Average Exercise Price | | |
Shares | | |
Weighted Average Exercise Price | |
Options outstanding at beginning of year | |
| 1,976,586 | | |
$ | 6.34 | | |
| 1,315,321 | | |
$ | 11.97 | |
Granted | |
| 874,548 | | |
| 10.13 | | |
| 720,047 | | |
| 7.19 | |
Exercised | |
| (82,708 | ) | |
| 3.65 | | |
| (4,660 | ) | |
| 5.20 | |
Forfeited | |
| (65,797 | ) | |
| 7.45 | | |
| (111,594 | ) | |
| 10.86 | |
Balance at September 30 | |
| 2,702,629 | | |
$ | 7.63 | | |
| 1,919,114 | | |
$ | 6.08 | |
| |
| | | |
| | | |
| | | |
| | |
Options exercisable at September 30: | |
| 1,440,231 | | |
$ | 6.26 | | |
| 882,215 | | |
$ | 5.92 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Grant Date Fair Value for options granted during the period: | |
| | | |
$ | 7.09 | | |
| | | |
$ | 4.87 | |
|
Schedule of Stock Options Outstanding and Exercisable |
The
following table summarizes additional information about stock options outstanding and exercisable at September 30, 2023:
Schedule of Stock Options Outstanding and Exercisable
Options Outstanding | |
Options Exercisable |
Options Outstanding | |
Weighted Average Remaining Contractual Life | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | | |
Options Exercisable | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
2,702,629 | |
| 8.09 | | |
$ | 7.63 | | |
$ | 5,355,467 | | |
1,440,231 | |
$ | 6.26 | | |
$ | 4,470,641 | |
|
Schedule of Assumptions for Fair Value of Equity-based Awards |
The
Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions
for the nine months ended September 30:
Schedule of Assumptions for Fair Value of Equity-based Awards
| |
2023 | | |
2022 | |
Risk-free interest rate | |
| 3.41% - 4.61% | | |
| 1.68% - 3.93% | |
Expected volatility | |
| 78.0 to 79.8% | | |
| 76.2% - 79.6% | |
Expected life (years) | |
| 5.25 to 6.08 | | |
| 5.29 to 6.25 | |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
|
Schedule of Unrecognized Compensation Cost |
Total
unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows:
Schedule of Unrecognized Compensation Cost
2023 | |
$ | 1,177,419 | |
| |
| |
2023 | |
$ | 1,177,419 | |
2024 | |
| 3,679,163 | |
2025 | |
| 2,465,972 | |
2026 | |
| 1,515,642 | |
2027 | |
| 635,575 | |
Total estimated compensation cost to be recognized | |
$ | 9,473,771 | |
|
Schedule of Stock-based Compensation Expense |
The
Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30:
Schedule of Stock-based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Stock-based compensation expense in operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 660,706 | | |
$ | 676,524 | | |
$ | 1,954,689 | | |
$ | 1,937,707 | |
General and administrative | |
| 447,931 | | |
| 546,530 | | |
| 1,704,213 | | |
| 1,561,077 | |
Total | |
$ | 1,108,637 | | |
$ | 1,223,054 | | |
$ | 3,658,902 | | |
$ | 3,498,784 | |
|
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v3.23.3
Debt (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Long-term Debt |
Long-term
debt consisted of the following at September 30, 2023 and December 31, 2022:
Schedule of Long-term Debt
| |
September 30, 2023 | | |
December 31, 2022 | |
Note payable | |
$ | 35,000,000 | | |
$ | 35,000,000 | |
Add: PIK interest (added to principal) | |
| 2,100,835 | | |
| 755,075 | |
Less: unamortized debt issuance costs | |
| (540,392 | ) | |
| (707,001 | ) |
Less: unamortized debt discount | |
| (53,669 | ) | |
| (65,000 | ) |
Total long-term debt | |
$ | 36,506,774 | | |
$ | 34,983,074 | |
|
Schedule of Long Term Debt Future Principal Payments |
Future
principal payments, including the incurred PIK interest, are as follows:
Schedule of Long Term Debt Future Principal Payments
| |
Years
Ending December 31, | |
| |
| |
2025 | |
$ | 13,912,813 | |
2026 | |
| 18,550,418 | |
2027 | |
| 4,637,604 | |
Total | |
$ | 37,100,835 | |
|
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v3.23.3
Net Loss Per Common Share (Details Narrative) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
2,702,629
|
1,919,114
|
2,702,629
|
1,919,114
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
7,266,102
|
309,652
|
7,266,102
|
309,652
|
Restricted Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
1,958
|
3,273
|
1,958
|
3,273
|
Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share |
10,608,730
|
0
|
10,608,730
|
0
|
X |
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v3.23.3
Schedule of Investment (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized Cost, as Adjusted |
$ 108,180,417
|
$ 144,015,954
|
Gross Unrealized Holding Gains |
5,138
|
71,156
|
Gross Unrealized Holding Losses |
|
|
Estimated Fair Value |
108,185,555
|
144,087,110
|
US Treasury Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized Cost, as Adjusted |
108,180,417
|
97,785,061
|
Gross Unrealized Holding Gains |
5,138
|
41,639
|
Gross Unrealized Holding Losses |
|
|
Estimated Fair Value |
$ 108,185,555
|
97,826,700
|
US Government Agencies Debt Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Amortized Cost, as Adjusted |
|
46,230,893
|
Gross Unrealized Holding Gains |
|
29,517
|
Gross Unrealized Holding Losses |
|
|
Estimated Fair Value |
|
$ 46,260,410
|
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v3.23.3
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
|
9 Months Ended |
|
Sep. 21, 2023 |
Jun. 29, 2023 |
Mar. 31, 2023 |
Sep. 30, 2023 |
Dec. 31, 2022 |
Class of Stock [Line Items] |
|
|
|
|
|
Common stock, shares authorized |
|
|
|
65,000,000
|
65,000,000
|
Common stock, par or stated value per share |
|
|
|
$ 0.001
|
$ 0.001
|
Common stock, shares outstanding |
|
|
|
22,369,393
|
21,667,250
|
Preferred stock, shares authorized |
|
|
|
2,500,000
|
2,500,000
|
Preferred stock, par or stated value per share |
|
|
|
$ 0.001
|
$ 0.001
|
Preferred stock, shares outstanding |
|
|
|
1,060,873
|
1,120,873
|
Declared Dividend |
|
|
|
$ 0
|
|
Series A Convertible Preferred Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Number of shares converted |
25,000
|
10,000
|
25,000
|
|
|
Conversion price |
$ 5.75
|
$ 5.75
|
$ 5.75
|
|
|
Common Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Number of shares issued in conversion |
250.0000
|
100.0000
|
250.0000
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
1,850,000
|
|
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v3.23.3
Schedule of Stock Options Activity (Details) - Share-Based Payment Arrangement, Option [Member] - $ / shares
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Offsetting Assets [Line Items] |
|
|
Shares, Options outstanding at beginning of year |
1,976,586
|
1,315,321
|
Weighted Average Exercise Price, Options outstanding at beginning of year |
$ 6.34
|
$ 11.97
|
Shares, Granted |
874,548
|
720,047
|
Weighted Average Exercise Price, Granted |
$ 10.13
|
$ 7.19
|
Shares, Exercised |
(82,708)
|
(4,660)
|
Weighted Average Exercise Price, Exercised |
$ 3.65
|
$ 5.20
|
Shares, Forfeited |
(65,797)
|
(111,594)
|
Weighted Average Exercise Price, Forfeited |
$ 7.45
|
$ 10.86
|
Shares, Options outstanding at end of year |
2,702,629
|
1,919,114
|
Weighted Average Exercise Price, Options outstanding at end of year |
$ 7.63
|
$ 6.08
|
Shares, options exercisable |
1,440,231
|
882,215
|
Weighted Average Exercise Price, Options exercisable |
$ 6.26
|
$ 5.92
|
Weighted Average Grant Date Fair Value for options granted during the period |
$ 7.09
|
$ 4.87
|
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v3.23.3
Schedule of Stock Options Outstanding and Exercisable (Details) - Share-Based Payment Arrangement, Option [Member]
|
9 Months Ended |
Sep. 30, 2023
USD ($)
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Options outstanding | shares |
2,702,629
|
Options outstanding, weighted average remaining contractual life |
8 years 1 month 2 days
|
Options outstanding, weighted average exercise price | $ / shares |
$ 7.63
|
Options outstanding, aggregate intrinsic value | $ |
$ 5,355,467
|
Options exercisable | shares |
1,440,231
|
Options exercisable, weighted average exercise price | $ / shares |
$ 6.26
|
Options exercisable, aggregate intrinsic value | $ |
$ 4,470,641
|
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v3.23.3
Schedule of Unrecognized Compensation Cost (Details)
|
Sep. 30, 2023
USD ($)
|
Share-Based Payment Arrangement [Abstract] |
|
2023 |
$ 1,177,419
|
2024 |
3,679,163
|
2025 |
2,465,972
|
2026 |
1,515,642
|
2027 |
635,575
|
Total estimated compensation cost to be recognized |
$ 9,473,771
|
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v3.23.3
Schedule of Stock-based Compensation Expense (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
$ 1,108,637
|
$ 1,223,054
|
$ 3,658,902
|
$ 3,498,784
|
Research and Development Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
660,706
|
676,524
|
1,954,689
|
1,937,707
|
General and Administrative Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
$ 447,931
|
$ 546,530
|
$ 1,704,213
|
$ 1,561,077
|
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v3.23.3
Stock-Based Compensation (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
9 Months Ended |
|
|
|
|
|
|
|
May 12, 2022 |
May 12, 2021 |
May 10, 2018 |
Oct. 25, 2017 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
May 11, 2023 |
Jan. 01, 2023 |
May 31, 2022 |
Jan. 01, 2022 |
Dec. 31, 2021 |
Jan. 01, 2021 |
May 31, 2020 |
May 2022 Exercise Price Modification [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option awards shares modified |
|
|
|
|
|
|
|
|
|
|
776,324
|
|
|
|
|
Stock option exercise price per share |
|
|
|
|
|
|
|
|
|
|
$ 5.50
|
|
|
|
|
Modification on stock-based compensation |
|
|
|
|
$ 30,188
|
$ 49,088
|
$ 107,490
|
$ 477,431
|
|
|
|
|
|
|
|
Remaining stock based compensation expense related to modification |
|
|
|
|
|
|
190,000
|
|
|
|
|
|
|
|
|
December 2021 Exercise Price Modification [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option awards shares modified |
|
|
|
|
|
|
|
|
|
|
|
|
311,000
|
|
|
Stock option exercise price per share |
|
|
|
|
|
|
|
|
|
|
|
|
$ 13.44
|
|
|
Modification on stock-based compensation |
|
|
|
|
15,773
|
21,778
|
49,617
|
75,562
|
|
|
|
|
|
|
|
Remaining stock based compensation expense related to modification |
|
|
|
|
|
|
114,000
|
|
|
|
|
|
|
|
|
May 2020 Exercise Price Modification [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option awards shares modified |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
203,750
|
Stock option exercise price per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 5.10
|
Modification on stock-based compensation |
|
|
|
|
$ 3,041
|
7,681
|
16,975
|
30,897
|
|
|
|
|
|
|
|
Remaining stock based compensation expense related to modification |
|
|
|
|
|
|
$ 3,000
|
|
|
|
|
|
|
|
|
2017 Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares reserved for issuance |
1,000,000
|
1,000,000
|
|
750,000
|
|
|
|
|
1,500,000
|
216,673
|
|
149,189
|
|
102,998
|
|
Stock option description |
|
|
|
increase automatically on January 1 of each year from 2024 through 2027
by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding
December 31, subject to the board’s discretion to reduce the amount of the increase in any particular year.
|
|
|
|
|
|
|
|
|
|
|
|
Additional shares authorized under plan |
500,000
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares available for issuance |
|
|
|
|
1,147,899
|
|
1,147,899
|
|
|
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized stock-based compensation expense |
|
|
|
|
$ 1,065,568
|
1,162,751
|
$ 3,516,180
|
3,329,969
|
|
|
|
|
|
|
|
Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized stock-based compensation expense |
|
|
|
|
$ 4,903
|
$ 7,245
|
$ 13,597
|
$ 36,686
|
|
|
|
|
|
|
|
Restricted stock awards outstanding |
|
|
|
|
1,958
|
3,273
|
1,958
|
3,273
|
|
|
|
|
|
|
|
Restricted stock awards vested |
|
|
|
|
0
|
250
|
|
|
|
|
|
|
|
|
|
Employee Stock Purchase Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized stock-based compensation expense |
|
|
|
|
$ 38,167
|
$ 53,058
|
$ 129,125
|
$ 132,129
|
|
|
|
|
|
|
|
Common stock, shares reserved for issuance |
|
|
100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option description |
|
|
number of shares equal to 0.5% of the total outstanding number of
shares of Company common stock as of the immediately preceding December 31.
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares available for issuance |
|
|
|
|
283,008
|
|
283,008
|
|
|
|
|
|
|
|
|
Change in common stock, shares reserved for issuance |
|
|
|
|
|
|
|
|
|
108,337
|
|
74,594
|
|
51,499
|
|
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v3.23.3
Schedule of Long-term Debt (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Debt Disclosure [Abstract] |
|
|
Note payable |
$ 35,000,000
|
$ 35,000,000
|
Add: PIK interest (added to principal) |
2,100,835
|
755,075
|
Less: unamortized debt issuance costs |
(540,392)
|
(707,001)
|
Less: unamortized debt discount |
(53,669)
|
(65,000)
|
Total long-term debt |
$ 36,506,774
|
$ 34,983,074
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v3.23.3
Subsequent Events (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
Oct. 18, 2023 |
Oct. 13, 2023 |
Sep. 21, 2023 |
Jun. 29, 2023 |
Mar. 31, 2023 |
Sep. 30, 2023 |
Dec. 31, 2022 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Common stock, par value |
|
|
|
|
|
$ 0.001
|
$ 0.001
|
Series A Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Number of shares converted |
|
|
25,000
|
10,000
|
25,000
|
|
|
Conversion price |
|
|
$ 5.75
|
$ 5.75
|
$ 5.75
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Number of shares issued in conversion |
|
|
250.0000
|
100.0000
|
250.0000
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Share price |
$ 8.699
|
|
|
|
|
|
|
Warrant exercise price |
$ 0.001
|
|
|
|
|
|
|
Gross proceeds |
$ 50
|
|
|
|
|
|
|
Percentage of liquidated damages |
100.00%
|
|
|
|
|
|
|
Subsequent Event [Member] | Series A Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Number of shares converted |
|
181,739
|
|
|
|
|
|
Conversion price |
$ 5.75
|
|
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Number of shares issued in conversion |
|
1,817,390
|
|
|
|
|
|
Subsequent Event [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Percentage of liquidated damages |
600.00%
|
|
|
|
|
|
|
Subsequent Event [Member] | Private Placement [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Pre-funded warrants to purchase of common stock, shares |
5,747,787
|
|
|
|
|
|
|
Common stock, par value |
$ 0.001
|
|
|
|
|
|
|
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