Cellectar Biosciences Inc
For the period ended Sep 30, 2024. Filed Nov 18, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 18, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Item 1. Financial Statements
CONDENSED CONSOLIDATED BALANCE SHEETS
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · 2024 · 2023 | ||||||
| ASSETS · · | ||||||
| CURRENT ASSETS: · · | ||||||
| Cash and cash equivalents | | $34,263,371 | | $9,564,988 | ||
| Prepaid expenses and other current assets | | 1,635,818 | | 888,225 | ||
| Total current assets | | 35,899,189 | | | 10,453,213 | |
| Property, plant & equipment, net | | 910,131 | | | 1,090,304 | |
| Operating lease right-of-use asset | | 454,166 | | | 502,283 | |
| Other long-term assets | | 29,780 | | | 29,780 | |
| TOTAL ASSETS | | $37,293,266 | | $12,075,580 | ||
| | | | | | | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | |
| CURRENT LIABILITIES: | | | | | | |
| Accounts payable and accrued liabilities | | $8,304,311 | | $9,178,645 | ||
| Warrant liability | | | 11,929,242 | | | 16,120,898 |
| Lease liability, current | | 80,821 | | 58,979 | ||
| Total current liabilities | | 20,314,374 | | 25,358,522 | ||
| Long-term lease liability, net of current portion | | 431,929 | | 494,003 | ||
| TOTAL LIABILITIES | | | 20,746,303 | | | 25,852,525 |
| COMMITMENTS AND CONTINGENCIES (Note 7) | | | | | | |
| MEZZANINE EQUITY: | | | | | | |
| Series D preferred stock, 111.11 shares authorized, issued and outstanding as of September 30, 2024 and December 31, 2023 | | 1,382,023 | | | 1,382,023 | |
| STOCKHOLDERS’ EQUITY (DEFICIT): | | | | | | |
| Series E-2 preferred stock, 1,225.00 shares authorized; 149.60 and 319.76 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | | 2,188,434 | | | 4,677,632 | |
| Series E-3 preferred stock, 2,205.00 shares authorized; 202.50 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | | 4,369,317 | | — | ||
| Series E-4 preferred stock, 1,715.00 shares authorized; 714.00 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | | | 7,057,793 | | | — |
| Common stock, $0.00001 par value; 170,000,000 shares authorized; 40,566,534 and 20,744,110 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | | 406 | | 207 | ||
| Additional paid-in capital | | 246,536,080 | | | 182,924,210 | |
| Accumulated deficit | | (244,987,090) | | (202,761,017) | ||
| Total stockholders’ equity (deficit) | | | 15,164,940 | | | (15,158,968) |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | $37,293,266 | | $12,075,580 | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||||||
| OPERATING EXPENSES: · · · · · | ||||||||||||
| Research and development | | $5,493,496 | | $7,034,656 | | $19,927,019 | | $19,528,898 | ||||
| General and administrative | | 7,834,181 | | 2,378,804 | | 19,105,853 | | 6,883,866 | ||||
| Total operating expenses | | 13,327,677 | | 9,413,460 | | 39,032,872 | | 26,412,764 | ||||
| | | | | | | | | | | | | |
| LOSS FROM OPERATIONS | | (13,327,677) | | (9,413,460) | | (39,032,872) | | (26,412,764) | ||||
| | | | | | | | | | | | | |
| OTHER INCOME (EXPENSE): | | | | | | | | | ||||
| Warrant issuance expense | | | (7,743,284) | | | (470,000) | | | (7,743,284) | | | (470,000) |
| Gain (loss) on valuation of warrants | | | 6,088,355 | | | (7,688,028) | | | 3,583,440 | | | (8,254,649) |
| Interest income | | 317,887 | | 51,110 | | 966,643 | | 247,925 | ||||
| Total other expense | | (1,337,042) | | (8,106,918) | | (3,193,201) | | (8,476,724) | ||||
| NET LOSS | | $(14,664,719) | | $(17,520,378) | | | (42,226,073) | | $(34,889,488) | |||
| NET LOSS PER SHARE — BASIC | | $(0.37) | | $(1.55) | | | (1.21) | | $(3.09) | |||
| NET LOSS PER SHARE — DILUTED | | $(0.40) | | $(1.55) | | | (1.39) | | $(3.09) | |||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC | | | 39,335,924 | | | 11,308,738 | | | 34,850,441 | | | 11,277,231 |
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED | | 39,794,220 | | 11,308,738 | | 35,545,500 | | 11,277,231 | ||||
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Series D Preferred · · · · · · · · · · · · · · · · Total | |||||||||||||||||||||||||
| · · Stock · · · Preferred Stock · · Common Stock · · Additional · · Accumulated · · Stockholders’ | |||||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Par Amount · Paid-In Capital · Deficit · (Deficit) Equity | |||||||||||||||||||||||||
| Balance at December 31, 2022 | 111.11 | | $1,382,023 | | | — | | $— | | 9,385,272 | | $94 | | $168,143,557 | | $(159,990,407) | | $8,153,244 | |||||||
| Conversion of pre-funded warrants into common stock | — | | | — | | | — | | | — | | 355,235 | | | 3 | | | — | | | — | | | 3 | |
| Stock-based compensation | | — | | | — | | | — | | | — | | — | | | — | | | 408,206 | | | — | | | 408,206 |
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | (7,190,470) | | | (7,190,470) |
| Balance at March 31, 2023 | | 111.11 | | | 1,382,023 | | | — | | | — | | 9,740,507 | | | 97 | | | 168,551,763 | | | (167,180,877) | | | 1,370,983 |
| Stock-based compensation | — | | | — | | | — | | | — | | — | | | — | | | 419,757 | | | — | | | 419,757 | |
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | (10,178,640) | | | (10,178,640) |
| Balance at June 30, 2023 | 111.11 | | | 1,382,023 | | | — | | | — | | 9,740,507 | | | 97 | | | 168,971,520 | | | (177,359,517) | | | (8,387,900) | |
| Issuance of Series E-1 preferred stock, net of issuance costs (Note 6) | | 1,225.00 | | | 17,820,000 | | | — | | | — | | — | | | — | | | — | | | — | | | — |
| Stock-based compensation | | — | | | — | | | — | | | — | | — | | | — | | | 497,878 | | | — | | | 497,878 |
| Exercise of warrants into common stock | | — | | | — | | | — | | | — | | 177,877 | | | 2 | | | 649,248 | | | — | | | 649,250 |
| Reclassification of pre-funded warrants to liability | | — | | | — | | | — | | | — | | — | | | — | | | (3,239,112) | | | — | | | (3,239,112) |
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | (17,520,378) | | | (17,520,378) |
| Balance at September 30, 2023 | | 1,336.11 | | $19,202,023 | | | — | | $— | | 9,918,384 | | $99 | | $166,879,534 | | $(194,879,895) | | $(28,000,262) | ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Balance at December 31, 2023 | | 111.11 | | $1,382,023 | | | 319.76 | | $4,677,632 | | 20,744,110 | | $207 | | $182,924,210 | | $(202,761,017) | | $(15,158,968) | ||||||
| Stock-based compensation | | — | | | — | | | — | | | — | | — | | | — | | | 454,363 | | | — | | | 454,363 |
| Conversion of pre-funded warrants into common shares | | — | | | — | | | — | | | — | | 1,079,132 | | | 11 | | | 3,972,529 | | | — | | | 3,972,540 |
| Exercise of warrants for preferred stock, net of issuance costs (Note 2) | | — | | | — | | | 2,205.00 | | | 47,577,000 | | — | | | — | | | — | | | — | | | 47,577,000 |
| Conversion of Series E-3 preferred stock into common stock | | — | | | — | | | (1,575.00) | | | (33,983,571) | | 9,890,099 | | | 100 | | | 33,983,471 | | | — | | | — |
| Exercise of warrants for common stock | | — | | | — | | | — | | | — | | 547,177 | | | 5 | | | 2,298,138 | | | — | | | 2,298,143 |
| Conversion of Series E-2 preferred stock into common stock | — | | | — | | | (82.26) | | | (1,203,346) | | 903,956 | | | 9 | | | 1,203,337 | | | — | | | — | |
| Retired shares | | — | | | — | | | — | | | — | | (8) | | | — | | | — | | | — | | | — |
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | (26,641,983) | | | (26,641,983) |
| Balance at March 31, 2024 | | 111.11 | | | 1,382,023 | | | 867.50 | | | 17,067,715 | | 33,164,466 | | | 332 | | | 224,836,048 | | | (229,403,000) | | | 12,501,095 |
| Stock-based compensation | | — | | | — | | | — | | | — | | — | | | — | | | 799,249 | | | — | | | 799,249 |
| Conversion of Series E-3 preferred stock into common stock | | — | | | — | | | (427.50) | | | (9,224,112) | | 2,684,458 | | | 26 | | | 9,224,086 | | | — | | | — |
| Net loss | — | | | — | | | — | | | — | | — | | | — | | | — | | | (919,371) | | | (919,371) | |
| Balance at June 30, 2024 | | 111.11 | | $1,382,023 | | | 440.00 | | $7,843,603 | | 35,848,924 | | $358 | | $234,859,383 | | $(230,322,371) | | $12,380,973 | ||||||
| Stock-based compensation | | | | | | | | | | | | | | | | | | | 1,534,054 | | | — | | | 1,534,054 |
| Issuance of E-4 preferred stock net of issuance costs | | — | | | — | | | 1,610.00 | | | 15,914,632 | | — | | | — | | | — | | | — | | | 15,914,632 |
| Conversion of Series E-2 preferred stock into common stock | | — | | | — | | | (87.90) | | | (1,285,851) | | 965,934 | | | 10 | | | 1,285,841 | | | — | | | — |
| Conversion of Series E-4 preferred stock into common stock | | — | | | — | | | (896.00) | | | (8,856,840) | | 3,750,909 | | | 38 | | | 8,856,802 | | | — | | | — |
| Stock option exercise into common stock | | — | | | — | | | — | | | — | | 767 | | | — | | | — | | | — | | | — |
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | (14,664,719) | | | (14,664,719) |
| Balance at September 30, 2024 | 111.11 | | $1,382,023 | | | 1,066.10 | | $13,615,544 | | 40,566,534 | | $406 | | $246,536,080 | | $(244,987,090) | | $15,164,940 | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Nine Months Ended | ||||||
| · · September 30, | ||||||
| · 2024 · 2023 | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: · · | ||||||
| Net loss | | $(42,226,073) | | $(34,889,488) | ||
| Adjustments to reconcile net loss to cash used in operating activities: | | | | | | |
| Depreciation and amortization | | 223,082 | | | 122,415 | |
| Stock-based compensation expense | | 2,787,666 | | | 1,325,841 | |
| Warrant issuance expense | | | 7,743,284 | | | 470,000 |
| Change in operating lease right-of-use asset | | 48,117 | | | 42,768 | |
| Change in fair value of warrants | | (3,583,440) | | | 8,254,649 | |
| Changes in: | | | | | | |
| Prepaid expenses and other current assets | | | (747,593) | | | (408,790) |
| Lease liability | | (40,232) | | (34,815) | ||
| Accounts payable and accrued liabilities | | (874,334) | | | 2,336,146 | |
| Cash used in operating activities | | (36,669,523) | | | (22,781,274) | |
| CASH FLOWS FROM INVESTING ACTIVITIES: | | | | | | |
| Purchases of property, plant & equipment | | (42,909) | | | (597,282) | |
| Cash used in investing activities | | (42,909) | | | (597,282) | |
| CASH FLOWS FROM FINANCING ACTIVITIES: | | | | | ||
| Proceeds from issuance of preferred stock and warrants, net of issuance costs | | — | | | 22,150,000 | |
| Proceeds from exercise of warrants, net of issuance costs | | | 61,410,815 | | | 348,641 |
| Cash provided by financing activities | | | 61,410,815 | | | 22,498,641 |
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | | | 24,698,383 | | | (879,915) |
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | | 9,564,988 | | | 19,866,358 | |
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | | $34,263,371 | | $18,986,443 | ||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | | | | | | |
| Settlement of warrants to equity | | $7,410,000 | | $— | ||
| Conversion of preferred stock to common stock | | $54,553,720 | | $— | ||
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
- NATURE OF BUSINESS AND ORGANIZATION
Cellectar Biosciences, Inc. (the Company) is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, leveraging the Company’s proprietary phospholipid drug conjugate™ (PDC™) delivery platform that specifically targets cancer cells and delivers improved efficacy and better safety as a result of fewer off-target effects.
Going Concern — As an emerging growth company, the Company has, by design, incurred significant recurring losses and used net cash in its operations since its inception as it devotes substantially all of its efforts towards researching, developing and seeking approval for its product candidates to be commercialized in the marketplace. As a result of these efforts, the Company had an accumulated deficit of approximately $244,987,000 as of September 30, 2024, and incurred a net loss of approximately $42,226,000 during the nine months ended September 30, 2024. The Company expects it will continue to generate significant losses and use net cash for the foreseeable future, until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace. While management believes one or more of the Company’s product candidates will be approved and successfully commercialized in the marketplace, no assurance can be provided any products will be approved or commercialized in a profitable manner.
To fund its research, development, and approval efforts, the Company has been heavily dependent on funding from private investors and public stockholders since its inception through the issuance of securities, such as common stock, convertible preferred stock, and warrants (outside capital). The Company expects to remain heavily dependent on outside capital to fund the Company’s operations for the foreseeable future until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace. While management believes additional outside capital will be secured as needed, no assurance can be provided that additional outside capital will be secured, or secured on terms that are acceptable to the Company.
As of the date the accompanying consolidated financial statements were issued (the “issuance date”), the Company’s available liquidity to fund the Company’s operations over the next twelve months beyond the issuance date was limited to approximately $28.6 million of unrestricted cash and cash equivalents. Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the second quarter of 2025. To improve the Company’s liquidity, management plans to secure additional outside capital via the sale of equity and/or debt securities or execute a strategic transaction. Management also plans to preserve liquidity, as needed, by implementing temporary cost saving measures. While management believes their plans will be successful, no assurance can be provided such plans will be effectively implemented over the next twelve months beyond the issuance date. In the event management’s plans are not effectively implemented, the Company will be required to seek other alternatives which may include, among others, the sale of the Company or its assets, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection.
These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared on the basis that the Company will continue to operate as a going concern, which contemplates it will be able to realize assets and settle liabilities and commitments in the normal course of business for the foreseeable future. Accordingly, the accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.
The condensed consolidated financial statements have been prepared by Cellectar Biosciences, Inc. in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Management believes the disclosures made in this document are adequate with respect to interim reporting requirements.
The accompanying Condensed Consolidated Balance Sheet as of December 31, 2023, has been derived from the Company’s audited financial statements. The accompanying Condensed Consolidated Balance Sheet as of September 30, 2024, and the Condensed Consolidated Statements of Operations, Cash Flows, and the Consolidated Statements of Stockholders’ Equity for the nine months ended September 30, 2024 and 2023, and the related interim information contained within the Notes to the Condensed Consolidated Financial Statements, have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions, rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information. Accordingly, they do not include all the information and the notes required by U.S. GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments which are of a nature necessary for the fair presentation of the Company’s consolidated financial position as of September 30, 2024, and consolidated results of its operations, cash flows, and stockholders’ equity for the nine months ended September 30, 2024 and 2023. The results for the nine months ended September 30, 2024, are not necessarily indicative of future results.
These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto included in the Company’s Form 10-K/A for the fiscal year ended December 31, 2023, which was filed with the SEC on October 29, 2024.
Principles of Consolidation — The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The Company consists ofone reportable segment.
Use of Estimates — The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include the assumptions used in the accrual for potential liabilities, the valuation of the warrant liability, the valuation of debt and equity instruments, the valuation of stock options issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.
Property, Plant & Equipment— Property, plant & equipment are stated at cost. Depreciation is provided using the straight-line method over the estimated useful lives of the assets (3 to 10 years). Leasehold improvements are depreciated over 64 months (their estimated useful life), which represents the full term of the lease at the time the leasehold improvements were capitalized. The Company’s only long-lived assets are property, plant & equipment and right-of-use (ROU) assets. Periodically, and at a minimum annually, the Company evaluates long-lived assets for potential impairment. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. Such analyses necessarily involve judgement. The Company did not experience any events or changes in circumstances that indicate the carrying amount of the assets may not be recoverable as of September 30, 2024. There wereno fixed asset impairment charges recorded during the nine months ended September 30, 2024 or 2023.
Right-of-Use (ROU)** **Asset and Lease Liabilities -The Company accounts for all material leases in accordance with FASB Accounting Standards Codification (ASC) Topic 842, Leases. ROU Assets are amortized over their estimated useful life, which represents the full term of the lease. See Note 8.
Stock-Based Compensation — The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value of stock option awards. The resulting compensation expense, net of forfeitures for awards that are not performance-based, is recognized on a straight-line basis over the service period of the award, which in the three and nine months ended September 30, 2024 and 2023, ranged from twelve months tothree years.
Research and Development — Research and development costs are expensed as incurred. The Company recognizes revenue and cost reimbursements from government grants when it is probable that the Company will comply with the conditions attached to the grant arrangement and the grant proceeds will be received. Government grants are recognized on a systematic basis over the periods in which the Company recognizes the related costs for which the government grant is intended to compensate. Specifically, when government grants are related to reimbursements for cost of revenues or operating expenses, the government grants are recognized as a reduction of the related expense in the Condensed Consolidated Statements of Operations. The Company records government grants receivable in the Condensed Consolidated Balance Sheets in prepaid expenses and other current assets.
Income Taxes— Income taxes are accounted for using the liability method of accounting. Under this method, deferred tax assets and liabilities are determined based on temporary differences between the financial statement basis and tax basis of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more-likely-than-not that some portion of the deferred tax assets will not be realized. Management has provided a full valuation allowance against the Company’s gross deferred tax asset. Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine whether the tax positions are more-likely-than-not to be sustained by the applicable tax authority. Tax positions deemed not to meet a more-likely-than-not threshold would be recorded as tax expense in the current year. There are no uncertain tax positions that require accrual to or disclosure in the financial statements as of September 30, 2024 and December 31, 2023.
Fair Value of Financial Instruments — The guidance under ASC Topic 825, Financial Instruments, requires disclosure of the fair value of certain financial instruments. Financial instruments in the accompanying financial statements consist of cash equivalents, prepaid expenses and other assets, accounts payable and accrued liabilities, and long-term obligations. The carrying amount of cash equivalents, prepaid expenses, other current assets and accounts payable approximate their fair value as a result of their short-term nature. (See Notes 2 and 3)
Warrants — The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity and ASC 815, Derivatives and Hedging. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require net cash settlement in a fundamental transaction outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding (see Note 2). If the warrants are liability-classified, valuation changes, as well as the cost to issue the warrants, are included in Other Income (Expense) in the financial statements (see Note 3). If these instruments are initially classified as either liabilities or equity and a subsequent assessment determines that the classification has changed, the Company reflects that change in the financial statements.
Preferred Stock — The Company accounts for preferred stock based upon their specific terms and the authoritative guidance in ASC 480 and ASC 815, including whether they are freestanding instruments, whether any redemption or conversion aspects exist and how they are required to be settled (particularly if there is a cash settlement aspect), whether they contain characteristics that are predominantly debt-like or equity-like, whether they have embedded derivatives, and if they have redemption features. Based upon analysis of these criteria, the preferred stock will be classified as either debt, temporary (or “mezzanine”) equity, or permanent equity. The resultant classification is then evaluated quarterly to determine whether any change to the classification is required.
Concentration of Credit Risk — Financial instruments that subject the Company to credit risk consist of cash and cash equivalents on deposit with financial institutions. The Company’s excess cash as of September 30, 2024 and December 31, 2023 is on deposit in interest-bearing accounts with well-established financial institutions. At times, such amounts may exceed the FDIC insurance limits. As of September 30, 2024, and December 31, 2023, uninsured cash balances totaled approximately $33,814,000 and $9,123,000, respectively.
Government Assistance — Reimbursements of eligible expenditures pursuant to government assistance programs are recorded as reductions of operating costs when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and when the reimbursement has been claimed. The determination of the amount of the claim, and accordingly the receivable amount, requires management to make calculations based on its interpretation of eligible expenditures in accordance with the terms of the programs. The reimbursement claims submitted by the Company are subject to review by the relevant government agencies. The Company currently has a cancer treatment research award through the National Cancer Institute (NCI) totaling approximately $2.0 million over a period of approximately three years. In September 2022, the Company was awarded $1.98 million in additional grant funding to expand the Company’s ongoing Phase 1 study of iopofosine I 131 in children and adolescents with inoperable relapsed or refractory high-grade gliomas (HGGs). The grant was awarded by the NCI based upon the initial signals of efficacy in the Phase 1 study, which is an international, open-label, dose escalation, safety study. The funding allows for an expansion from Part 1a into the Part 1b portion of the ongoing Phase 1 pediatric study.
During the nine months ended September 30, 2024 and 2023, the Company received approximately $602,000 and $1,314,000 in NCI grant funding under the grants described above, respectively, all of which was reported as a reduction of research and development expenses.
Recently Adopted Accounting Pronouncements Not Yet Adopted— In December 2023, the FASB issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures, which is intended to enhance the transparency and decision usefulness of income tax disclosures. Public business entities are required to adopt this standard for annual fiscal periods beginning after December 15, 2024, and early adoption is permitted. The Company is evaluating the impact the adoption of this guidance will have on its consolidated financial statements and related disclosures.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280). The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. This update is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023 - 07 will have on its condensed consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating this guidance to determine the impact it may have on its condensed consolidated financial statements.
The Company evaluates all ASUs issued by the FASB for consideration of their applicability to the financial statements. The Company has assessed all ASUs issued but not yet adopted and concluded that those not disclosed are not relevant to the Company or are not expected to have a material impact.
Restatement of Previously Issued Consolidated Financial Statements — During the third quarter of 2024 the Company determined that it was necessary to re-evaluate its accounting treatment for certain previously issued warrants and preferred stock. Additionally, the Company identified certain operating costs previously presented as research and development expenses which are more appropriately classified as general and administrative. In accordance with Staff Accounting Bulletins No. 99 (SAB No. 99) Topic 1.M, “Materiality” and SAB No. 99 Topic 1.N “Considering the Effects of Misstatements when Quantifying Misstatements in the Current Year Financial Statements,” the Company assessed the materiality of these errors to its previously issued consolidated financial statements. Based upon the Company’s evaluation of both quantitative and qualitative factors, the Company concluded the errors were material to the Company’s previously issued consolidated financial statements for the fiscal years ended December 31, 2023 and 2022, as well as those for the first quarter of 2024. Accordingly, this Form 10-Q presents the Company’s Restated Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2023 as reflected in the Company’s Form 10-K/A for the year ended December 31, 2023.
- STOCKHOLDERS’ EQUITY
July 2024 Warrant Inducement
On July 21, 2024, the Company, entered into a warrant exercise inducement (the “Inducement”) with certain holders of its September 2023 Tranche B warrants, pursuant to which the holders agreed to exercise the warrants to purchase 1,610 shares of the Company’s Series E-4 Convertible Voting Preferred Stock, par value $0.00001 per share (the “Series E-4 preferred stock”) which is convertible to 6,739,918 shares of the Company’s common stock in the aggregate, at a reduced, as-converted common stock price of $2.52 per share, in exchange for the Company’s issuance of new warrants (the “Inducement Warrants”), with varying termination dates and exercise prices. The Company received gross proceeds of $19.4 million and net proceeds of $17.5 million.
The Inducement Warrants have the following terms:
| ● | The 2024 Tranche A warrants have an exercise price of $2.52 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement that the FDA has assigned a Prescription Drug User Fee Act goal date for review of iopofosine I 131, and (ii) July 21, 2029. |
| ● | The 2024 Tranche B warrants have an exercise price of $4.00 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131, and (ii) July 21, 2029. |
| ● | The 2024 Tranche C warrants have an exercise price of $5.50 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement that it has recorded quarterly gross revenues from sales of iopofosine I 131 in the United States in excess of $10 million and (ii) July 21, 2029. |
Due to a cash settlement feature that requires cash settlement in event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance. As a result, and in accordance with the guidance in ASC 815, the warrants issued in July 2024 are deemed to be liabilities. All such liabilities are required to be presented at fair value, with changes reflected in financial results for the period. See Note 3 for the related valuation.
In accordance with the guidance above, the Company recorded the Inducement Warrants and preferred stock at their respective fair values. Utilizing valuation techniques described in Note 3 below, the Company computed the fair value of the Inducement Warrants as $12.0 million and recorded the preferred stock at approximately $15.9 million, which represented its fair value of $17.0 million less allocated issuance costs. The value of the preferred stock and Inducement Warrants sold exceeded the proceeds received by the Company and the fair value of the Tranche B warrants that were exercised in the transaction, which was approximately $2.6 million at the time of exercise. The value in excess of the net proceeds and the fair value of the Tranche B warrants of approximately $7.7 million is reflected in Other Expense.
Subsequent to the issuance of the Series E-4 preferred stock and prior to September 30, 2024, investors who held 896.00 shares of Series E-4 preferred stock converted them into 3,750,909 shares of common stock. There remain 714.00 shares of Series E-4 preferred stock outstanding as of September 30, 2024.
September 2023 Private Placement
On September 8, 2023, in a private placement with certain institutional investors, the Company issued 1,225 shares of Series E-1 preferred stock, along with Tranche A warrants to purchase 2,205 shares of Series E-3 preferred stock and Tranche B warrants to purchase 1,715 shares of Series E-4 preferred stock. Shares of Series E preferred stock were issued at a fixed price of $20,000 per share, resulting in gross proceeds of $24.5 million and net proceeds of approximately $22.2 million after placement agent fees and other customary expenses.
The conversion prices for the preferred stock are as follows: for the Series E-1 or E-2 preferred stock, $1.82 per share of common stock, or a total of 13,461,538 shares of common stock; for the Series E-3 preferred stock, $3.185 per share of common stock, or a total of 13,846,154 shares of common stock; and for the Series E-4 preferred stock, $4.7775 per share of common stock, or a total of 7,179,487 shares of common stock, in each case subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization. The warrants were exercisable as follows:
| ● | Tranche A warrants, for an aggregate exercise price of $44.1 million, exercisable for Series E-3 preferred stock until the earlier of September 6, 2026, or 10 trading days after the Company’s announcement of positive topline data from the Waldenstrom’s macroglobulinemia CLOVER WaM pivotal trial; and, |
| ● | Tranche B warrants, for an aggregate exercise price of $34.3 million, exercisable for Series E-4 preferred stock until the earlier of September 6, 2028, or 10 days following the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131. |
As of December 31, 2023, the Tranche A and Tranche B warrants did not qualify as derivatives; however, they did not meet the requirements necessary to be considered indexable in the Company’s stock. As a result, and in accordance with the guidance in FASB ASC 815, the warrants were deemed to be liabilities. As of September 30, 2024, the Tranche B warrants do not qualify as derivatives and meet the requirements necessary to be considered indexable in the Company’s stock. However, due to a cash settlement feature that requires cash settlement in event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance. As a result, and in accordance with the guidance in ASC 815, the Tranche B warrants continue to be deemed
liabilities. All such liabilities are required to be presented at fair value, with changes reflected in financial results for the period. As discussed above, the majority of the Tranche B warrants were exercised in July 2024. See Note 3 for the related valuation.
When issued, the Series E-1 preferred stock had a redemption feature; therefore, it was classified as mezzanine equity as of September 30, 2023. The Series E-1 preferred stock also had a liquidation preference, which was calculated as an amount per share equal to the greater of (i) two times (2X) the Original Per Share Price, together with any declared, unpaid dividends, or (ii) such amount per share as would have been payable had all shares of Series E-1 preferred stock been converted into Common Stock immediately prior to such Liquidation. While the Series E-1 preferred was outstanding, this resulted in both the Tranche A and Tranche B warrants being considered puttable by virtue of the liquidation preference impacting the disposition of these warrants in the event of a liquidation. In accordance with the guidance in ASC 480, a puttable warrant is deemed to be a liability. These features only applied to the Series E-1 preferred stock when it was outstanding; upon stockholder approval of the transaction, which was obtained by the Company at a special meeting of stockholders held on October 25, 2023, the Series E-1 preferred stock immediately converted into either Series E-2 preferred stock and/or common stock, dependent upon the beneficial ownership position of the holder.
The net proceeds from the September 2023 Private Placement were allocated first to the fair value of the Tranche A and Tranche B warrants, which had a fair value upon issuance of $4,800,000, with the remainder, or $17,820,000, allocated to the Series E-1 preferred stock. Upon stockholder approval of the transaction, the entire amount that had been assigned to mezzanine equity was reclassified to Series E-2 preferred stock and is a component of permanent equity, as is reflected in the financial statements. As a result of the stockholder approval, Series E-1 preferred stock was fully extinguished in accordance with the terms of the financing. The outstanding shares of Series E preferred stock were classified as permanent equity upon issuance.
Series E preferred stock is convertible to common stock at the request of the holder, subject to the holder not exceeding certain beneficial ownership percentages as stipulated in the financing agreement. Subsequent to the issuance of the Series E-2 preferred stock and prior to December 31, 2023, preferred holders converted 905.24 shares of preferred stock into 9,947,684 shares of common stock at the stated rate of $1.82 per common share, resulting in 319.76 shares of Series E-2 preferred stock outstanding as of December 31, 2023.
During the nine months ended September 30, 2024,170.16 shares of Series E-2 preferred stock were converted into 1,869,890 shares of common stock. There remain 149.60 shares of Series E-2 preferred stock outstanding as of September 30, 2024.
In January 2024, the Company released topline data from its pivotal, Phase 2b CLOVER WaM trial. In accordance with the terms of the Tranche A warrant, the warants’ expiration accelerated to 10 trading days after the topline data release. Warrant holders exercised the Tranche A warrants in their entirety, resulting in the Company issuing 2,205.00 shares of Series E-3 preferred stock, which are convertible to common stock at the stated rate of $3.185 per share, and receiving gross proceeds of $44.1 million and net proceeds of $42.8 million (see Note 3).
During the nine months ended September 30, 2024, investors who held 2,002.50 shares of Series E-3 preferred stock converted them into 12,574,557 shares of common stock. There remain 202.50 shares of Series E-3 preferred stock outstanding as of September 30, 2024.
October 2022 Public Offering and Private Placement
On October 25, 2022, the Company completed a registered direct offering of 3,275,153 shares of the Company’s common stock at $2.085 per share and warrants to purchase up to an aggregate of 3,275,153 shares of common stock in a concurrent private placement priced at-the-market under Nasdaq rules. In a separate concurrent private placement transaction, the Company offered and sold pre-funded warrants to purchase an aggregate of 1,875,945 shares of common stock and warrants to purchase an aggregate of 1,875,945 shares of common stock. The warrants are immediately exercisable at an exercise price of $1.96 per share and will expire on the fifth anniversary of the closing date. Each pre-funded warrant had a purchase price of $2.08499, is immediately exercisable at an exercise price of $0.00001 per share and will not expire until exercised in full. The registered direct offering and private placements resulted in total gross proceeds of approximately $10.7 million with net proceeds to the Company of approximately $9.6 million after deducting estimated offering expenses.
During the nine months ended September 30, 2024,1,079,132 pre-funded warrants were converted into 1,079,132 shares of common stock, and 547,177 warrants issued in October 2022 were exercised for net proceeds of approximately $1.1 million. There wereno such conversions or exercises in the nine months ended September 30, 2023.
Warrants
The following table summarizes information with regard to outstanding warrants to purchase stock as of September 30, 2024:
| · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · Number of Common · · · · · · | |||||||
| | | Shares Issuable | | | | | |
| | | Upon Exercise of | | | | | |
| · · Outstanding · · Exercise · · | |||||||
| Offering · Warrants · Price · Expiration Date · | |||||||
| 2024 Tranche A Warrants | | 6,739,918 | | $2.52 | | July 21, 2029 | |
| 2024 Tranche B Warrants | | 8,214,278 | | $4.00 | | July 21, 2029 | |
| 2024 Tranche C Warrants | | 4,267,152 | | $5.50 | | July 21, 2029 | |
| 2023 Tranche B Preferred Warrants | | 439,560 | | $4.7775 | | September 8, 2028 | |
| 2022 Common Warrants | | 4,201,044 | | $1.96 | | October 25, 2027 | |
| June 2020 Series H Common Warrants | | 720,796 | | $12.075 | | June 5, 2025 | |
| October 2017 Series D Common Warrants | | 31,085 | | $178.00 | October 14, 2024 | | |
| Total | 24,613,833 | | | ||||
All warrants in the table above are liability-classified.
- FAIR VALUE
In accordance with the Fair Value Measurements and Disclosures Topic of ASC 820, the Company groups its financial assets and financial liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded, and the reliability of the assumptions used to determine fair value:
| ● | Level 1: Input prices quoted in an active market for identical financial assets or liabilities. |
| ● | Level 2: Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices for identical assets, and liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data. |
| ● | Level 3: Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market. |
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying value of cash and cash equivalents approximates fair value as maturities are less than three months. The carrying amounts reported for other current financial assets and liabilities approximate fair value because of their short-term nature. As of September 30, 2024, the Company doesnot have any Level 1 or Level 2 liabilities.
July 2024 Warrants
As part of the July 2024 financing the Company issued Tranche A, B, and C warrants (the 2024 Warrants) to purchase shares of common stock (see Note 2). The fair value of the 2024 warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model. The PWERM is a scenario-based methodology that estimates the fair value of the Company’s different classes of equity based upon an analysis of future values for the Company, assuming various outcomes. Under both models, assumptions and estimates are used to value the warrants. The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained. The quantitative elements associated with the inputs impacting the fair value measurement of the 2024 Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock.
The 2024 Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $12,000,000 and $6,900,000 as of July 21, 2024, the date of issuance, and September 30, 2024, respectively, which is included in the warrant liability caption on the accompanying balance sheets.
The following table summarizes the modified option-pricing assumptions used on September 30, 2024 and December 31, 2023:
| · · · · · | |||
|---|---|---|---|
| · July 21, · September 30, | |||
| · · 2024 · · 2024 | |||
| Volatility | 75.9-82.0% | 80.6-83.0% | |
| Risk-free interest rate | 4.10-4.20% | 3.50-3.60% | |
| Expected life (years) | 0.7-5.0 | 0.5-4.8 | |
| Dividend | 0% | 0% | |
September 2023 Warrants
As part of the September 2023 financing (see Note 2) the Company issued Tranche A and Tranche B warrants (the 2023 Warrants) to purchase shares of preferred stock which, on an as-converted basis, represented an aggregate of 21,025,641 shares of common stock. The fair value of the Tranche A and B warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model. The PWERM is a scenario-based methodology that estimates the fair value of the Company’s different classes of equity based upon an analysis of future values for the Company, assuming various outcomes. Under both models, assumptions and estimates are used to value the preferred stock warrants. The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained. The quantitative elements associated with the inputs impacting the fair value measurement of the 2023 Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock.
As previously described, all of the Tranche A warrants were exercised in January 2024. Additionally, in July 2024, the holders of the Tranche B warrants exercised all but 105.00 of the Tranche B warrants outstanding. As a result, those warrants were marked-to-market on July 21, 2024, the date of the exercise and subsequent settlement.
The 2023 Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $30,000 and $4,200,000 as of September 30, 2024 and December 31, 2023, respectively, which is included in the warrant liability caption on the accompanying balance sheets.
The following table summarizes the modified option-pricing assumptions used on September 30, 2024 and December 31, 2023:
| | | | | | |
|---|---|---|---|---|---|
| · September 30, · December 31, · | |||||
| | | 2024 | | 2023 | |
| Volatility | | 81.0-85.0% | 82.0-83.0% | ||
| Risk-free interest rate | 4.41% | 3.80-5.40% | |||
| Expected life (years) | 0.8-4.2 | | 0.3-4.7 | | |
| Dividend | 0% | 0% | |||
At the time the Tranche A warrants were exercised, their fair value, calculated as the difference between the common stock conversion rate in the Series E-3 preferred stock and the trading price of the stock when the warrants were exercised, was determined to be $4,800,000. Due to the settlement of the Tranche A warrants relieving the Company of any further related obligation, the liability was reclassified to equity in accordance with ASC 815. The Tranche B warrants continue to be classified as a liability due to a cash settlement feature in the agreement.
October 2022 Warrants
In October 2022 the Company issued a total of 5,151,098 common warrants that are immediately exercisable with afive-year life and a strike price of $1.96 for shares of common stock (the 2022 Common Warrants), and 1,875,941 pre-funded warrants (the 2022 Pre-Funded Warrants) to acquire shares of common stock (see Note 6). The 2022 Pre-Funded Warrants are exercisable by the holder upon payment of the par value of the common stock and are classified as Level 2 liabilities as their value is equal to the Company’s common stock value less the par value.
The fair value of the 2022 Common Warrants was determined by utilizing a Black-Scholes option-pricing model. The quantitative elements associated with the inputs impacting the fair value measurement of the 2022 Common Warrants include the value per share of the underlying common stock, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock. These warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized. The following table summarizes the assumptions used at each financial reporting date:
| · · · · · | ||||
|---|---|---|---|---|
| · September 30, · December 31, | ||||
| · · 2024 · · 2023 · | ||||
| Volatility | | 78.3% | 81.1% | |
| Risk-free interest rate | 3.58% | 3.84% | ||
| Expected life (years) | 3.1 | 3.8 | | |
| Dividend | 0% | 0% | ||
The following table summarizes the changes in the fair market value of the warrants which are classified within the Level 3 fair value hierarchy.
| | | | |
|---|---|---|---|
| | Level 3 | ||
| Fair value of Level 3 liabilities as of December 31, 2023 | | $13,131,691 | |
| Change in warrant fair value | | | (4,566,773) |
| Issuance of July 2024 Inducement Warrants | | | 12,000,000 |
| Settlement of 2023 Tranche A Warrants to equity | | | (4,800,000) |
| Settlement of 2023 Tranche B Warrants to equity | | | (2,610,000) |
| Exercise of October 2022 Warrants | | (1,225,676) | |
| June 30, 2024, fair value of Level 3 liabilities | | $11,929,242 | |
- STOCK-BASED COMPENSATION
Accounting for Stock-Based Compensation
2021 Stock Incentive Plans
The Company maintains the 2021 Stock Incentive Plan (the “2021 Plan”). The Company utilizes stock-based compensation incentives as a component of its employee and non-employee director and officer compensation philosophy. A committee of the Board of Directors determines the terms of the awards granted and may grant various forms of equity-based incentive compensation. Currently, these incentives consist principally of stock options and restricted shares. All outstanding awards under the 2015 Stock Incentive Plan (the “2015 Plan”) remained in effect according to the terms of the 2015 Plan. Any shares that are currently available under the 2015 Plan and any shares underlying 2015 Plan awards which are forfeited, cancelled, reacquired by the Company or otherwise terminated are added to the shares available for grant under the 2021 Plan.
Under the current stock option award program, all options become exercisable between one and three years after issuance and expire after ten years. The fair value of each stock option award is estimated on the grant date using the Black-Scholes option-pricing model. Volatility is based on the Company’s historical common stock volatility. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time. The expected term of stock options granted is based on an estimate of when options will be exercised in the future. Forfeitures are recorded as they occur. No dividends have been recorded historically.
At the annual meeting of stockholders held on June 14, 2024, the Company’s stockholders approved an increase in the number of shares of common stock available for issuance under the 2021 Stock Incentive Plan by 7,000,000 to 9,368,900.
The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||
| · · September 30, · · September 30, | ||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||
| · · · · · · · · · · · · | ||||||||
| Employee and director stock option grants: · · · · | ||||||||
| Research and development | | $309,933 | | $89,172 | | $453,158 | | $227,896 |
| General and administrative | | 1,224,121 | | 408,706 | | 2,334,508 | | 1,097,945 |
| Total stock-based compensation | | $1,534,054 | | $497,878 | | $2,787,666 | | $1,325,841 |
In December 2023, the Company granted 2,776,000 contingent, non-statutory stock option awards at an exercise price of $2.65 per share to employees and directors, and in March 2024 the Company granted 200,000 contingent, non-statutory stock option awards at an exercise price of $3.63 and $3.35 per share to our employees. Each of these grants was contingent on approval of an increase in the shares available in the 2021 Stock Incentive Plan that was approved by the stockholders at the annual meeting of stockholders held on June 14, 2024. In accordance with the removal of the contingency, the Company began recognizing the expense for these awards in June 2024.
Assumptions Used in Determining Fair Value
Valuation and amortization method. The fair value of each stock award is estimated on the grant date using the Black-Scholes option-pricing model. The estimated fair value of employee stock options is amortized to expense using the straight-line method over the required service period which is generally the vesting period. The estimated fair value of the non-employee options is amortized to expense over the period during which a non-employee is required to provide services for the award (usually the vesting period).
Volatility. The Company estimates volatility based on the Company’s historical volatility since its common stock is publicly traded.
Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption.
Expected term. The expected term of stock options granted is based on an estimate of when options will be exercised in the future. The Company applies the simplified method of estimating the expected term of the options, as described in the SEC’s Staff Accounting Bulletins 107 and 110, as the historical experience is not indicative of the expected behavior in the future. The expected term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted. The Company applied the simplified method to non-employees who have a truncation of term based on termination of service and utilizes the contractual life of the stock options granted for those non-employee grants which do not have a truncation of service.
Forfeitures. The Company records stock-based compensation expense only for those awards that are expected to vest and accounts for forfeitures as they occur.
Dividends. The Company has not historically recorded dividends related to stock options.
Exercise prices for all grants made during the nine months ended September 30, 2024 and September 30, 2023, were equal to the market value of the Company’s common stock on the date of grant.
- INCOME TAXES
The Company accounts for income taxes in accordance with the liability method of accounting. Deferred tax assets or liabilities are computed based on the difference between the financial statement and income tax basis of assets and liabilities, and net operating loss carryforwards (“NOLs”), using the enacted tax rates. Deferred income tax expense or benefit is based on changes in the asset or liability from period to period. The Company did not record a provision or benefit for federal, state or foreign income taxes for the nine months ended September 30, 2024 or 2023 because the Company has experienced losses on a tax basis since inception. Management has provided a full allowance against the value of its gross deferred tax assets in light of the continuing losses and uncertainty associated with the utilization of the NOLs in the future.
The Company also accounts for the uncertainty in income taxes related to the recognition and measurement of a tax position taken or expected to be taken in an income tax return. The Company follows the applicable accounting guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition related to the uncertainty in income tax positions. No uncertain tax positions have been identified.
- NET LOSS PER SHARE
Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period. The pre-funded warrants are considered common shares outstanding for the purposes of the basic net loss per share calculation due to the nominal cash consideration and lack of other contingencies for issuance of the underlying common shares. Diluted net loss attributable to common stockholders per share is computed by dividing net loss attributable to common stockholders, as adjusted, by the sum of the weighted average number of shares of common stock and the dilutive potential common stock equivalents then outstanding. Potential common stock equivalents consist of stock options, warrants, and convertible preferred shares. In accordance with ASC Topic 260, Earnings per Share, diluted earnings per share are the amount of earnings for the period available to each share of common stock outstanding during the reporting period and to each share that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares outstanding during the reporting period. In the quarter ended September 30, 2024, the common warrants issued in October 2022 were dilutive. In all other periods presented, all outstanding warrants were antidilutive.
| | | | | | | |
|---|---|---|---|---|---|---|
| Periods ended September 30, 2024 · Three Months · Nine Months | ||||||
| Net loss | | $(14,664,719) | | $(42,226,073) | ||
| Dilutive effect of warrant liability | | | (1,428,355) | | (7,283,786) | |
| Net loss allocated to common shares | | $(16,093,074) | | $(49,509,859) | ||
| | | | | | | |
| Weighted average common shares outstanding - basic | | | 39,335,924 | | 34,850,441 | |
| Dilutive effect of warrant liability | | | 458,296 | | 695,060 | |
| Weighted average common shares outstanding - diluted | | | 39,794,220 | | 35,545,500 | |
| | | | | | | |
| Net loss per share - diluted | | $(0.40) | | $(1.39) | ||
The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would be antidilutive:
| · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | |||||||
| · · September 30, · · September 30, | |||||||
| · 2024 · 2023 · 2024 · 2023 | |||||||
| Warrants | 20,412,789 | | 27,148,243 | | 20,412,789 | | 27,148,243 |
| Preferred shares on an as-converted-into-common-stock basis | 6,015,662 | | 111,111 | | 6,015,662 | 111,111 | |
| Stock options | 5,359,624 | | 2,280,756 | | 5,359,624 | 2,280,756 | |
| Total potentially dilutive shares | 31,788,075 | | 29,540,110 | | 31,788,075 | 29,540,110 | |
- COMMITMENTS AND CONTINGENCIES
Legal
The Company may be involved in legal matters and disputes in the ordinary course of business. It is not anticipated that the outcome of such matters and disputes will materially affect the Company’s financial statements.
8. LEASES
Operating Lease Liability
In June 2018, the Company executed an agreement for office space in the Borough of Florham Park, Morris County, New Jersey to be used as its headquarters (HQ Lease). The HQ Lease commenced upon completion of certain improvements in October 2018.
On December 30, 2022, the Company entered into an Amended Agreement of Lease of the HQ Lease (Amended HQ Lease), with CAMPUS 100 LLC (the “Landlord”). Under the Amended HQ Lease, which was accounted for as a modification of the initial lease, the Company will continue to lease 3,983 square feet of rentable area on the second floor of a building located at 100 Campus Drive in Florham Park, New Jersey, commencing on March 1, 2023 until April 30, 2029. The Company also has an option to extend the term of the Amended HQ Lease for one additional 60-month period.
Under the terms of the Amended Lease, the Company Company’s previously paid security deposit of $75,000 will be reduced to $23,566, and the aggregate rent due over the term of the Amended Lease is approximately $918,000, which will be reduced to approximately $893,000 after certain rent abatements. The Company will also be required to pay its proportionate share of certain operating expenses and real estate taxes applicable to the leased premises. After rent abatements, the rent is approximately $11,800 per month for the first year and then escalates thereafter by 2% per year for the duration of the term. The Company has not entered into any leases with related parties.
Discount Rate
The Company has determined an appropriate interest rate to be used in evaluating the present value of the Amended Lease liability considering factors such as the Company’s credit rating, borrowing terms offered by the U.S. Small Business Administration, amount of lease payments, quality of collateral and alignment of the borrowing term and lease term. The Company considers 14% per annum as reasonable to use as the incremental borrowing rate for the purpose of calculating the liability under the Amended Lease.
Maturity Analysis of Short-Term and Operating Leases
The following table approximates the dollar maturity of the Company’s undiscounted payments for its short-term leases and operating lease liabilities as of September 30, 2024:
| | | | |
|---|---|---|---|
| Years ending September 30, · · | |||
| Remaining period of 2024 | | $36,000 | |
| 2025 | | | 146,000 |
| 2026 | | | 150,000 |
| 2027 | | | 153,000 |
| 2028 | | | 155,000 |
| Thereafter | | | 53,000 |
| Total undiscounted lease payments | | | 693,000 |
| Less: Imputed interest | | | (180,000) |
| Present value of lease liabilities | | $513,000 | |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.