Matinas BioPharma Holdings Inc
For the period ended Dec 31, 2024. Filed Apr 15, 2025.
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FY2024 · Filed Apr 15, 2025
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Financial Statements
To the Board of Directors and Stockholders of Matinas BioPharma Holdings, Inc
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Matinas BioPharma Holdings, Inc and Subsidiaries as of December 31, 2024 and 2023, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the position of the Company as of December 31, 2024 and 2023, and the results of their operations and their cash flows for each of the years in then ended in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has recurring net losses and net cash flow used in operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
In-process Research and Development
As described in Note 3, 7, and 12 to the financial statements, In-process Research and Development (“IPR&D”) is tested for impairment on an annual basis, or more frequently if indicators of impairment exist. During the fourth quarter of 2024, management noted that an indicator of potential impairment existed due to the cessation of negotiations with a prospective development partner, a reduction in force, and the suspension of research and development efforts. The fair value of the IPR&D is estimated with the income approach using a discounted cash flow method. Management’s cash flow projections included significant judgments and assumptions relating to the plans contemplated for the commercialization of the IPR&D, along with the amount and timing of projected future cash flows and discount rates. Impairment is calculated by comparing the fair value of the IPR&D to its carrying value. As a result of this quantitative analysis, the Company recorded an IPR&D impairment charge of $0.8 million, representing the excess of the carrying value over its estimated fair value.
We identified the impairment assessment of IPR&D as a critical audit matter due to the significant judgment by management when developing the fair value estimates. This led to a high degree of auditor judgment and subjectivity and effort in performing procedures and evaluating management’s significant assumptions related to amount and timing of projected future cash flows and discount rates. Additionally, the audit effort involved the use of professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial statements. These procedures included, among others (i) understanding management’s process for developing the fair value estimate; (ii) evaluation of management’s plans and assumptions and probability of the alternatives for the monetization of the IPR&D asset and the related identifiable cash flows; (iii) evaluating the appropriateness of the discounted cash flow model used by management; and (iv) evaluating the reasonableness of the significant assumptions used by management related to the amount and timing of projected future cash flows and discount rates. Evaluating management’s assumptions related to the amount and timing of projected future cash flows and discount rates involved evaluating whether the assumptions used by management were reasonable considering the consistency with external market and industry data. Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the discounted cash flow model, (ii) the reasonableness of the discount rates assumption, and (iii) the appropriateness of probability and assumptions used in evaluating the reasonableness of the fair value of the IPR&D asset.
/s/ EisnerAmper LLP
We have served as the Company’s auditor since 2011
EISNERAMPER LLP
Iselin, New Jersey
April 15, 2025
(in thousands, except for share data)
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| ASSETS: | ||
| Current assets: | ||
| Cash and cash equivalents | $7,284 | $4,787 |
| Marketable debt securities | — | 8,969 |
| Restricted cash – security deposit | 50 | 50 |
| Prepaid expenses and other current assets | 691 | 1,737 |
| Total current assets | 8,025 | 15,543 |
| Non-current assets: | ||
| Leasehold improvements and equipment - net | 468 | 1,923 |
| Operating lease right-of-use assets - net | 1,680 | 3,064 |
| Finance lease right-of-use assets - net | 8 | 21 |
| In-process research and development | 2,260 | 3,017 |
| Goodwill | — | 1,336 |
| Restricted cash - security deposit | 200 | 200 |
| Total non-current assets | 4,616 | 9,561 |
| Total assets | $12,641 | $25,104 |
| LIABILITIES AND STOCKHOLDERS’ EQUITY: | ||
| Current liabilities: | ||
| Accounts payable | $95 | $514 |
| Accrued expenses and other liabilities | 1,805 | 1,447 |
| Operating lease liabilities - current | 761 | 656 |
| Financing lease liabilities - current | 5 | 5 |
| Total current liabilities | 2,666 | 2,622 |
| Non-current liabilities: | ||
| Deferred tax liability | 257 | 341 |
| Operating lease liabilities - net of current portion | 2,116 | 2,877 |
| Financing lease liabilities - net of current portion | 12 | 18 |
| Total non-current liabilities | 2,385 | 3,236 |
| Total liabilities | 5,051 | 5,858 |
| Stockholders’ equity: | ||
| Common stock par value $0.0001 per share, 250,000,000 shares authorized at December 31, 2024 and 2023, respectively; 5,086,985 and 4,345,291 issued and outstanding as of December 31, 2024 and 2023, respectively | 1 | — |
| Additional paid-in capital | 207,413 | 195,040 |
| Accumulated deficit | (199,824) | (175,573) |
| Accumulated other comprehensive loss | — | (221) |
| Total stockholders’ equity | 7,590 | 19,246 |
| Total liabilities and stockholders’ equity | $12,641 | $25,104 |
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| For the Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Revenue: | ||
| Contract Revenue | $— | $1,096 |
| Costs and Expenses: | ||
| Research and development | 11,433 | 14,489 |
| General and administrative | 8,729 | 10,373 |
| Impairment charges of goodwill and other intangible assets | 2,093 | — |
| Impairment charges of other assets | 2,338 | — |
| Total costs and expenses | 24,593 | 24,862 |
| Loss from operations | (24,593) | (23,766) |
| Sale of New Jersey net operating loss & tax credits | — | 484 |
| Other income, net | 262 | 340 |
| Loss before tax | $(24,331) | $(22,942) |
| Income tax benefit | 80 | — |
| Net loss | $(24,251) | $(22,942) |
| Net loss per share – basic and diluted | $(4.98) | $(5.28) |
| Weighted average common shares outstanding: | ||
| Basic and diluted | 4,865,829 | 4,345,291 |
| Other comprehensive gain, net of tax | ||
| Unrealized gain on securities available-for-sale | 221 | 603 |
| Other comprehensive gain, net of tax | 221 | 603 |
| Comprehensive loss | $(24,030) | $(22,339) |
Consolidated Statements of Changes in Stockholders’ Equity
(in thousands, except for share data)
| Common Stock · Additional Paid-in · Accumulated · Accumulated Other Comprehensive · Total Stockholders’ | ||||||
|---|---|---|---|---|---|---|
| Shares* | Amount | Capital | Deficit | (Loss)/Income | Equity | |
| Balance, December 31, 2022 | 4,345,291 | $— | $190,092 | $(152,631) | $(824) | $36,637 |
| Stock-based compensation | — | — | 4,948 | — | — | 4,948 |
| Other comprehensive income | — | — | — | — | 603 | 603 |
| Net loss | — | — | — | (22,942) | — | (22,942) |
| Balance, December 31, 2023 | 4,345,291 | $— | $195,040 | $(175,573) | $(221) | $19,246 |
| Stock-based compensation | — | — | 3,195 | — | — | 3,195 |
| Issuance of common stock and warrants in public offering, net of stock issuance cost ($877) | 671,033 | 1 | 9,178 | — | — | 9,179 |
| Issuance of common stock in reverse stock split | 70,661 | — | — | — | — | — |
| Other comprehensive income | — | — | — | — | 221 | 221 |
| Net loss | — | — | — | (24,251) | — | (24,251) |
| Balance, December 31, 2024 | 5,086,985 | $1 | $207,413 | $(199,824) | $— | $7,590 |
| * | Adjusted to reflect the impact of the 1-for-50 reverse stock split effective as of August 30, 2024. |
|---|
(in thousands)
| For the Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash flows from operating activities: | ||
| Net loss | $(24,251) | $(22,942) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation and amortization | 365 | 385 |
| Loss on disposal of equipment | — | 1 |
| Stock-based compensation expense | 3,195 | 4,948 |
| Amortization of operating lease right-of-use assets | 602 | 548 |
| Amortization of finance lease right-of-use assets | 5 | 8 |
| Amortization of bond (premium)/discount | (17) | 107 |
| Impairment charges of goodwill and other intangible assets | 2,093 | — |
| Impairment charges of other assets | 2,338 | — |
| Income tax benefit | (84) | — |
| Changes in operating assets and liabilities: | ||
| Prepaid expenses and other current assets | 587 | 3,983 |
| Accounts payable | (419) | (103) |
| Accrued expenses and other liabilities | 356 | (1,651) |
| Operating lease liabilities | (655) | (562) |
| Net cash used in operating activities | (15,885) | (15,278) |
| Cash flows from investing activities: | ||
| Purchases of marketable debt securities | (8,437) | — |
| Proceeds from sales of marketable debt securities | 17,645 | 13,460 |
| Purchases of leasehold improvements and equipment | — | (218) |
| Net cash provided by investing activities | 9,208 | 13,242 |
| Cash flows from financing activities: | ||
| Net proceeds from public offerings of common stock and warrants | 9,179 | — |
| Payments of capital lease liability – principal | (5) | (7) |
| Net cash provided by (used in) financing activities | 9,174 | (7) |
| Net decrease in cash, cash equivalents and restricted cash | 2,497 | (2,043) |
| Cash, cash equivalents and restricted cash at beginning of period | 5,037 | 7,080 |
| Cash, cash equivalents and restricted cash at end of period | $7,534 | $5,037 |
| Supplemental non-cash financing and investing activities: | ||
| Unrealized gain on marketable debt securities | $221 | $603 |
Note 1 –Description of Business
Matinas BioPharma Holdings Inc. (“Holdings”) is a Delaware corporation formed in 2013. Holdings is the parent company of Matinas BioPharma, Inc. (“BioPharma”), and Matinas BioPharma Nanotechnologies, Inc. (“Nanotechnologies,” formerly known as Aquarius Biotechnologies, Inc.), its operating subsidiaries (“Nanotechnologies”, and together with “Holdings” and “BioPharma”, “the Company”). The Company is a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology (LNC Platform).
The Company’s lead product candidate is MAT2203 (oral amphotericin B), a highly potent antifungal drug which, by virtue of LNC delivery, has been made oral, safe, and well-tolerated for prolonged administration in patients with life-threatening invasive fungal infections. Following the successful EnACT Phase 2 trial in the treatment of cryptococcal meningitis, MAT2203 is now positioned for a single, Phase 3 registration trial (the “ORALTO trial”) in support of a New Drug Application (“NDA”) for the treatment of invasive aspergillosis in patients with limited treatment options.
The Company had also been seeking to develop an internal pipeline of products utilizing the LNC Platform to encapsulate small molecules and small oligonucleotides and facilitate targeted and extrahepatic delivery to desired cells and tissues without toxicity, with a focus on small molecule oncology applications as well as the formulation and delivery of small oligonucleotides with a primary therapeutic focus on inflammation.
Following an 80% reduction in workforce implemented in late October 2024, the Company has been reassessing its strategic plan while implementing a cost-cutting strategy and paused further clinical development of MAT2203 with the goal of consummating a licensing, sale or other similar transaction as soon as possible to advance the development of MAT2203 into Phase 3. In addition, the Company continues to engage with the FDA to keep the MAT2203 Investigational New Drug Application (“IND”) active and is actively maintaining and prosecuting intellectual property relating to MAT2203 and to the LNC Platform generally as well as maintaining all of its obligations under its license agreement with Rutgers University. The Company also continues to support the patients in its Expanded/Compassionate Use Access Program with the assistance of outside medical clinician consultants. As a result of the reduction in force, the Company has paused the internal development of a pipeline of products utilizing the LNC Platform as it evaluates strategic alternatives for those early-stage programs in oncology and inflammatory diseases.
The Company remains engaged in an ongoing partnership process for MAT2203, seeking one or more development and/or commercialization partners. The Company will require either (i) the consummation of a partnership transaction, or (ii) raising additional capital, prior to commencing the ORALTO trial. In the event a partnership is consummated, the partner may seek to revise the ORALTO trial or could determine a completely new development program and pathway for MAT2203. There can be no assurance that the Company will be successful in consummating a transaction involving MAT2203.
Note 2 –Liquidity, Plan of Operations and Going Concern
The Company has experienced net losses and negative cash flows from operations each period since its inception. Through December 31, 2024, the Company had an accumulated deficit of $199,824. The Company’s net loss for the years ended December 31, 2024 and 2023 was $24,251 and $22,942, respectively.
The Company expects operating expenses to be lower in the near term compared to recent years until such time as additional funding is secured to support initiation of the Phase 3 registration trial for MAT2203 and advancement of the LNC platform delivery technology. The Company expects that its research and development expenses will increase if it moves forward with additional clinical studies for its current product candidates and development of additional product candidates. If the Company obtains U.S. Food and Drug Administration (“FDA”) approval for one or more of its product candidates, the Company expects that its expenses will continue to increase once the Company reaches commercial launch. As a result, the Company expects to continue to incur substantial losses for the foreseeable future, and that these losses will be increasing.
As of December 31, 2024, the Company had cash and cash equivalents of $7,284 and restricted cash of $250. In addition, during the second quarter of 2025, the Company generated net proceeds of $3,020 from the sale of Preferred Stock (see Note 17). The Company does not believe that the cash and cash equivalents on hand are sufficient to fund planned operations beyond the next twelve months from the filing date of these financial statements. As a result, substantial doubt exists about the Company’s ability to continue as a going concern.
The ability of the Company to continue as a going concern is dependent upon securing one or more partners to monetize the value of MAT2203, the ability to control its operating expenses, future sales of common stock through the At-The-Market Sales Agreement (“Sales Agreement”) with BTIG, LLC and securing additional financing. While the Company believes in the viability of this strategy and believes the actions presently being taken by the Company provide the opportunity for it to continue as a going concern, there can be no assurance the Company will be successful in its implementation. In particular, utilization of the Sales Agreement may not be viable due to market conditions and new financing may not be available on acceptable terms, or at all. Moreover, under the terms of the Preferred Stock sales agreement, the Company is prohibited, subject to certain exceptions, from issuing, entering into any agreement to issue, or announcing the issuance or proposed issuance of any shares of common stock or common stock equivalents until November 2025. These consolidated financial statements do not include any adjustments related to the recoverability and classification of asset amounts or the amounts and classification of liabilities that might be necessary if the Company is unable to continue as a going concern.
Note 3 –Summary of Significant Accounting Policies
Basis of presentation and principles of consolidation
The accompanying consolidated financial statements include the consolidated accounts of Holdings and its wholly owned subsidiaries, BioPharma, and Nanotechnologies. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and reflect the operations of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation.
Reverse Stock Split
On August 30, 2024, the Company effected a 1-for-50 reverse stock split of its issued and outstanding common stock (the “Reverse Stock Split”). The Company’s common stock began trading on a split adjusted basis on September 3, 2024. No fractional shares were issued as a result of the Reverse Stock Split as fractional shares of Common Stock were rounded up to the nearest whole share. Unless otherwise noted in these consolidated financial statements, all shares of common stock, warrants convertible into shares of common stock, stock options, per share information, and related parameters specified in this annual report have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented. Refer to Note 14 –Stockholders’ Equity for additional information related to the Reverse Stock Split.
Financial impact of events beyond our control
Our financial condition and results of operations may be impacted by factors we may not be able to control, such as pandemics, global supply chain disruptions, global trade disputes and/or political instability. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening these risks. Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related costs and clinical trial expenses, negatively impacting our results of operations.
The Company’s financial results for the years ended December 31, 2024 and 2023 were not significantly impacted by factors beyond our control, such as those described above. However, the Company cannot predict the impact of any of these factors on future results or the Company’s ability to raise capital due to a variety of factors, including but not limited to the continued good health of Company employees, the ability of service providers and suppliers to continue to operate and deliver, the ability of the Company to maintain operations, and any government and/or public actions taken in response to these factors.
Use of estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Significant items subject to such estimates and assumptions include, but are not limited to, the Company’s research and development expenses and the assessment of the impairment of long-lived assets, including goodwill, intangible assets, and other long-lived assets.
Segment and geographic information
The Company adopted Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, as of January 1, 2024. This ASU requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), an amount for other segment items with description of composition, and disclosure of the title and position of the CODM.
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decisionmaker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The Company considers its chief executive officer to be the Company’s CODM. The CODM manages its operations and allocates resources based on the Company’s consolidated results and therefore operates as one segment.
Segment revenue, profit or loss, significant segment expenses and other segment items - The accounting policies of the Company’s single operating and reportable segment are the same as those described in this Summary of Significant Accounting Policies. The Company’s method for measuring segment profitability includes net income(loss), which the CODM uses to assess performance and make decisions for resource allocation, consistent with the measurement principals for net income (loss) as reported on the Company’s consolidated statement of operations. The significant expenses regularly reviewed by the CODM are consistent with those reported on the Company’s consolidated statement of operations, and expenses are not regularly reviewed on a more disaggregated basis for purposes of assessing segment performance and deciding how to allocate resources. The measure of segment assets is reported.
The adoption of these disclosure requirements did not have a material impact on its consolidated financial statements and related disclosures.
Cash, cash equivalents and restricted cash
The Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable debt securities. Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term U.S. treasury bonds that mature within three months of settlement date. The Company presents restricted cash with cash and cash equivalents in the Consolidated Statements of Cash Flows. Restricted cash represents funds the Company is required to set aside to cover building operating leases and other purposes. For a complete disclosure of the Company’s cash, cash equivalents and restricted cash, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities.
Marketable Debt Securities
Marketable debt securities, all of which are available-for-sale, consist of U.S. treasury bonds, U.S. government notes and corporate debt securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive loss, except for losses from impairments which are determined to be other-than-temporary. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. The Company reviews its portfolio of available-for-sale debt securities, using both qualitative and quantitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. Realized gains and losses and declines in value judged to be other-than-temporary are included in the determination of net loss and are included in other income, net. Fair values are based on quoted market prices at the reporting date. Interest and dividends on available-for-sale securities are included in other income, net. For a complete disclosure of the Company’s marketable debt securities, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities.
Concentration of credit risk
The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable debt securities. The Company’s investment policy is to invest only in institutions that meet high credit quality standards and establishes limits on the amount and time to maturity of investments with any individual counterparty. Balances are maintained at U.S. financial institutions and may from time to time exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limit of $250 per depositor, per insured bank for each account ownership category. The Company has not experienced any credit losses associated with its balances in such accounts for the years ended December 31, 2024 and 2023.
Leasehold improvements and equipment
Leasehold improvements and equipment are stated at cost less accumulated depreciation and amortization , and impairment. Depreciation on equipment is computed using the straight-line method over the estimated useful lives of the assets, which range from three toten years , except for certain equipment that has been reduced to salvage value in connection with the Company’s impairment analysis and is no longer being depreciated, see Note 12 – Impairment Charges. Capitalized costs associated with leasehold improvements are amortized on a straight-line basis over the lesser of the estimated useful life of the asset or the remaining term of the lease.
Upon retirement or sale, the cost of assets disposed of and related accumulated depreciation and amortization is removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. For a complete disclosure of the Company’s leasehold improvements and equipment, see Note 6 – Leasehold Improvements and Equipment.
Goodwill and other intangible assets
Goodwill is recorded when consideration paid for an acquired entity exceeds the fair value of the net assets acquired. Goodwill is not amortized but rather is assessed for impairment at least annually on a reporting unit basis, or more frequently when events and circumstances indicate the goodwill may be impaired.
The goodwill impairment test is performed at the reporting unit level. The fair value of the Company’s reporting unit is determined using an income approach, which involves the use of estimates and assumptions, including projected future operating results and cash flows, the cost of capital, and financial measures derived from observable market data of comparable public companies. The Company estimates and compares the fair value of its reporting unit to its carrying value including goodwill. If the fair value is less than the carrying value, an impairment expense is recorded for the difference between those values and limited to the total carrying amount of goodwill.
Indefinite lived intangible assets are comprised of in-process research and development (“IPR&D”) and represent projects acquired in a business combination that have not reached technological feasibility or that lack regulatory approval at the time of acquisition. These IPR&D assets are reviewed for impairment annually, or sooner if events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.
The assessment of the Company’s indefinite lived intangible asset involves comparing the fair value of the asset, determined using the income approach which is based on discounted cash flow techniques, to the carrying value of the asset. The fair value determination is based on the concept of evaluating the highest and best use of the asset (group) in the hands of a market participant and considers the current use and any other use that is financially feasible, justifiable, and reasonably probable. If the fair value is less than the carrying value, an impairment expense is recorded for the difference between those values.
During the fourth quarter of 2024, the Company identified impairment indicators for its goodwill and other intangible assets, primarily due to the terminated partnership negotiations for the future development & commercialization of MAT2203 and subsequent cost-cutting measures. The Company completed the required quantitative impairment test which resulted in recognizing a full non-cash impairment charge equal to the carrying amount of goodwill and a partial impairment charge related to IPR&D. See Notes 7 - Goodwill and Other Intangible Assets and 12 – Impairment Charges. The Company did not record impairment charges related to goodwill or IPR&D during the year ended December 31, 2023.
** Long-lived assets**
The Company reviews leasehold improvements and equipment, operating lease right-of-use assets and other long-lived asset for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Recoverability is measured by comparing its carrying amount with the future net undiscounted cash flows the assets expected to generate. If such assets are considered to be impaired, the impairment is measured as the difference between the carrying amount of the assets and the Level 3 fair value of assts using the present value of the future net cash flows generated by the respective long-lived assets.
Determining fair value requires the use of estimates and assumptions. Such estimates and assumptions include revenue growth rates, estimated cost structure and operating expense, weighted average costs of capital, and future market conditions, among others.
Following a triggering event in the four quarter of 2024, the Company completed an impairment test for long-lived assets, which resulted in non-cash impairment charges. See Note 12 – Impairment Charges. The Company didnot record an impairment charge related to its long-lived assets during the year ended December 31, 2023.
Leases
The Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 842, “Leases”, establishes a right-of-use (“ROU”) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. ROU assets are evaluated for impairment as a long-lived asset. Lessor accounting under the new standard is substantially unchanged. Additional qualitative and quantitative disclosures are also required. For a complete disclosure of the Company’s leases, see Note 8 – Leases.
Income taxes
Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates in the period that includes the enactment date.
The Company adopted the provisions of ASC 740-10 and has analyzed its filing positions in 2024 and 2023 in jurisdictions where it may be obligated to file returns. The Company believes that its income tax filing position and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain income tax positions have been recorded. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company hadno accrual for interest or penalties as of December 31, 2024.
Since the Company incurred net operating losses in every tax year since inception, the 2014 through 2023 income tax returns are subject to examination and adjustments by the Internal Revenue Service for at least three years following the year in which the tax attributes are utilized.
Fair Value Measurements
As defined in ASC 820 “Fair Value Measurement”, fair value measurements should be disclosed separately by three levels of the fair value hierarchy. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs (quoted prices in active markets) and minimized the use of unobservable inputs (the Company’s assumptions) when developing fair value measurements, in accordance with the established fair value hierarchy. For a complete disclosure of the Company’s fair value measurements, see Note 5 – Fair Value Measurements.
Stock-based compensation
Stock-based compensation to employees consist of stock option grants and restricted shares. The Company accounts for stock-based compensation under the provisions of ASC 718-10,Compensation – Stock Compensation, which requires all share-based payments to employees, non-employees and directors, including grants of stock options and restricted shares, to be recognized in the consolidated statements of operations and comprehensive loss based on their fair values on the date of grant over the requisite service period, which is generally the vesting period of the respective award. Forfeitures are accounted for as they occur. Generally, the Company issues stock option awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company classifies stock-based compensation expense in the same manner in which the awards recipient’s payroll or service provider’s costs are classified.
The Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC Topic 505, subtopic 50,Equity-Based Payments to Non-Employeesbased upon the fair-value of the underlying instrument. The equity instruments, consisting of stock options granted to consultants, are valued using the Black-Scholes valuation model. The Company calculates the fair value of option grants utilizing the Black-Scholes pricing model and estimates the fair value of restricted stock based upon the estimated fair value or the common stock.
The resulting compensation expense for both employee and non-employee awards is generally recognized on a straight-line basis over the requisite service period of the award.
Basic and diluted net loss per common share
Net loss per share information is determined using the two-class method, which includes the weighted-average number of shares of common stock outstanding during the period and other securities. Under the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2) the if-converted method.
During the years ended December 31, 2024 and 2023, diluted earnings per common share is the same as basic earnings per common share because, as the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise of all outstanding stock options and warrants would have an anti-dilutive effect. The reconciliation of the anti-dilutive shares as of December 31, 2024 and 2023 are as follows:
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options | 687,356 | 934,159 |
| Warrants | 666,667 | — |
| Total | 1,354,023 | 934,159 |
Revenue recognition
Pursuant to Topic 606, the Company recognizes revenue to depict the transfer of promised goods or services to a customer in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 outlines a five-step process for recognizing revenue from customer contracts that includes i) identification of the contract with a customer, ii) identification of the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the separate performance obligations in the contract, and v) recognizing revenue associated with performance obligations as they are satisfied.
At contract inception, the Company assesses the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.
The Company did not record any revenue for the year ended December 31, 2024. For the year ended December 31, 2023, the Company’s revenues primarily consist of contract research revenue from the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform. For a complete disclosure of the Company’s Revenue Recognition, see Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements.
Collaboration Agreements
The Company assess whether its collaboration agreements are subject to ASC Topic 808,Collaborative Arrangements (Topic 808) based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of Topic 808, the Company will apply by analogy the unit of account guidance under Topic 606 to identify distinct performance obligations, and then determine whether a customer relationship exists for each distinct performance obligation. If the Company determines a performance obligation within the arrangement is with a customer, the Company applies the guidance in Topic 606. If a portion of a distinct bundle of goods or services within an arrangement is not with a customer, then the unit of account is not within the scope of Topic 606, and the recognition and measurement of that unit of account shall be based on analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election.
The terms of such arrangements typically include payments to the Company for one or more of the following: up-front fees; development and regulatory payments; product supply services; research and development cost reimbursements; profit-sharing arrangements; and royalties on certain products if they are successfully commercialized. As part of the accounting for these arrangements, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include forecasted revenues, clinical development timelines and costs, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
*Up-front License Fees:*If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company would recognize revenues from nonrefundable up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license, which generally would occur at or near the inception of the contract. For licenses that are bundled with other promises, the Company would utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenues from nonrefundable up-front fees. The Company will evaluate the measure of progress at the end of each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
*Research and Development Milestone Payments:*At the inception of each arrangement that includes development milestone payments, the Company will evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been resolved. The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which the Company will recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achieving such development and regulatory milestones and any related variable consideration constraint, and if necessary, adjust the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis.
*Research and Development Cost Reimbursements:*The Company’s collaboration arrangements may include promises of future clinical development and drug safety services, as well as participation on certain joint committees. When such services are provided to a customer or partner, and they are distinct from the licenses provided to the Company’s collaboration partners, these promises are accounted for as a separate performance obligation which the Company estimates using internal development costs incurred and projections through the term of the arrangements. The Company records revenues for these services as the performance obligations are satisfied over time based on measure of progress. However, if the Company concludes that its collaboration partner is not a customer for those collaborative research and development activities, it presents such payments as a reduction of research and development expenses.
*Research and Development Arrangement:*Under the terms of our research and development agreement with the CFF Agreement, the Company did not account for this arrangement in accordance with Topic 606. However, the Company has determined that it is a partner under a collaboration agreement as it shares in the risks and rewards that would be received if the product is successful and commercialized. Therefore the funds received under the terms of this agreement will be recorded as reimbursements of research and development costs and reduce the research and development expenses in the Company’s Statements of Operations and Comprehensive Loss. The Company records the reimbursements for certain materials and other research and development costs associated with the agreement when it is probable that a significant reversal in the amount of cumulative costs have been recognized. During the years ended December 31, 2024 and 2023, the Company recognized $0 and $88, respectively, of reimbursed research and development costs associated with the CFF Agreement. For a complete disclosure of the CFF Agreement, see Note 9 – Collaboration Agreements, Collaboration Agreements, and other Research and Development Agreements.
Research and development expenses
Research and development expenses primarily consist of costs associated with the preclinical and clinical development of our product candidate portfolio, including the following:
| ● | external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”) and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product; and |
|---|---|
| ● | employee-related expenses, including salaries, benefits and share-based compensation expense. |
Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use, costs of prototypes used in research and development, consultant fees and amounts paid to certain of our collaborative partners.
All research and development expenses are charged to operations as incurred in accordance with FASB ASC Topic 730, Research and Development. The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made.
Accrued Research and Development Expenses
As part of the process of preparing the Company’s financial statements, the Company is required to estimate its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. Certain of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and adjust if necessary. The significant estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities.
The Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjust the accrual or prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented.
Patent expenses
Legal fees and other direct costs incurred in obtaining and protecting patents are also expensed as incurred and are included in general and administrative expenses in the consolidated statements of operations.
Other comprehensive loss
Other comprehensive loss consists of net gains/(losses) and unrealized losses on marketable debt securities available-for-sale and is presented in the Consolidated Statements of Operations and Comprehensive Loss.
Recent accounting pronouncements
In December 2023, the FASB issued ASU No. 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which expands annual disclosure requirements related to the rate reconciliation and income taxes paid disclosures. ASU 2023-09 requires consistent categories and greater disaggregation of information in the rate reconciliation and income taxes paid to be disaggregated by jurisdiction. The updated standard is effective for fiscal years beginning after December 15, 2024. Early adoption is permitted and the update may be applied on a prospective basis with retrospective application permitted. The Company is currently evaluating the impact of this standard on the Company’s Consolidated Financial Statements.
Note 4 –Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities
The Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable debt securities. Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term U.S. treasury bonds that mature within three months of settlement date.
Cash, Cash Equivalents and Restricted Cash
The Company presents restricted cash with cash and cash equivalents in the Consolidated Statements of Cash Flows. Restricted cash at each of December 31, 2024 and 2023 of $250 represents funds the Company is required to set aside as collateral, primarily for one of the Company’s operating leases and other purposes.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Consolidated Balance Sheets to the total of the amounts in the Consolidated Statements of Cash Flows as of December 31, 2024, December 31, 2023 and December 31, 2022:
| December 31, 2024 | December 31, 2023 | December 31, 2022 | |
|---|---|---|---|
| Cash and cash equivalents | $7,284 | $4,787 | $6,830 |
| Restricted cash included in current/non-current assets | 250 | 250 | 250 |
| Cash, cash equivalents and restricted cash in the statement of cash flows | $7,534 | $5,037 | $7,080 |
Marketable Debt Securities
The Company has classified its investments in marketable debt securities as available-for-sale and as a current asset. The Company’s investments in marketable debt securities are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity. Unrealized losses and gains are classified as other comprehensive (loss)/income and costs are determined on a specific identification basis. Realized gains and losses from marketable debt securities are recorded in other income, net. The Company did not incur any realized gains and losses during the years ended December 31, 2024 and 2023. For the years ended December 31, 2024 and 2023, the Company recorded unrealized gains of $221 and $603, respectively. As of December 31, 2024 and 2023, the Company had net accumulated unrealized losses of $0 and $221, respectively.
The Company did not own any marketable debt securities at December 31, 2024. The following tables summarize the Company’s marketable debt securities at December 31, 2023:
| Amortized · Unrealized · Unrealized | ||||
|---|---|---|---|---|
| Cost | Gain | (Loss) | Fair Value | |
| U.S. Treasury Bonds | $999 | $— | $(3) | $996 |
| U.S. Government Notes | 8,191 | — | (218) | 7,973 |
| Total marketable debt securities | $9,190 | $— | $(221) | $8,969 |
All debt securities classified as available-for-sale matured within one year of December 31, 2023.
The Company determined that the unrealized (losses) and gains are temporary as of December 31, 2024 and 2023. Unrealized (losses) and gains generally are the result of increases in the risk premiums required by market participants rather than an adverse change in cash flows for a fundamental weakness in the credit quality of the issuer or underlying assets.
Note 5 -Fair Value Measurements
The Company uses the fair value hierarchy to measure the value of its financial instruments. The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each level within the hierarchy is described below:
| ● | Level 1 – Quoted prices for identical assets or liabilities in active markets. |
|---|---|
| ● | Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable. |
| ● | Level 3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable and for which assumptions are used based on management estimates. |
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
The carrying amounts of cash equivalents, current portion of restricted cash, prepaid expenses and other current assets, accounts payable, current portion of lease liabilities and accrued expenses approximate fair value due to the short-term nature of these instruments.
A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows:
The Company did not own any marketable debt securities at December 31, 2024. The following tables summarize the Company’s marketable debt securities measured on a recurring basis at December 31, 2023:
| Fair Value Hierarchy | ||||
|---|---|---|---|---|
| December 31, 2023 | Total | (Level 1) | (Level 2) | (Level 3) |
| Assets | ||||
| Marketable Debt Securities: | ||||
| U.S. Treasury Bonds | $996 | $996 | $— | $— |
| U.S. Government Notes | 7,973 | — | 7,973 | — |
| Total | $8,969 | $996 | $7,973 | $— |
U.S. treasury bonds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical assets in active markets. Marketable debt securities consisting of U.S. government notes and corporate debt securities are classified as Level 2 and are valued using quoted market prices in markets that are not active.
Fair Values Measured on a Non-recurring Basis
The Company’s non-financial assets, such as property, plant and equipment, and intangible assets, including goodwill and IPR&D, are recorded at fair value upon acquisition and are remeasured only if an impairment charge is recognized. The Company remeasured the fair value of its long-lived assets upon the occurrence of triggering events in the fourth quarter of 2024. For the year ended December 31, 2023, the Company did not incur a triggering event and did not have any assets or liabilities measured at fair value on a non-recurring basis. See Note 12 - Impairment Charges for more information on the impairment losses recorded during the year ended December 31, 2024 for assets measured on a non-recurring basis.
Note 6 –Leasehold Improvements and Equipment
Leasehold improvements and equipment, summarized by major category, consist of the following for the years ended December 31, 2024 and 2023:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Equipment | $1,535 | $2,463 |
| Leasehold improvements | 993 | 1,155 |
| Total | 2,528 | 3,618 |
| Less: accumulated depreciation and amortization | 2,060 | 1,695 |
| Leasehold improvements and equipment, net | $468 | $1,923 |
Depreciation and amortization expense for the years ended December 31, 2024 and 2023 was $365 and $385, respectively. During the years ended December 31, 2024 and 2023, the Company purchased equipment and leasehold improvements of $0 and $218, respectively. During the year ended December 31, 2023, the Company recorded an asset write-off of $60, including $59 of related accumulated depreciation.
Impairment of Long-Lived Assets
During the fourth quarter of 2024, the Company recorded in its consolidated statement of operations and comprehensive loss a $1,090 charge for an impairment loss associated with its leasehold improvements and equipment. The Company didnot record an impairment charge during the year ended December 31, 2023.
Note 7 –Goodwill and Other Intangible Assets
The following table provides the gross and net carrying value of goodwill as follows:
| Amounts | |
|---|---|
| Balance at December 31, 2023 | $1,336 |
| Impairment of goodwill | (1,336) |
| Balance at December 31, 2024 | $— |
The Company completed its annual impairment test for goodwill during the fourth quarter of 2024, which resulted in full impairment of the Company’s $1,336 of goodwill. The goodwill impairment is reflected in impairment charge of goodwill and other intangible assets in the Company’s consolidated statements of operations and comprehensive loss for the year ended December 31, 2024. The Company did not record a Goodwill impairment charge during the year ended December 31, 2023.
The following table provides the gross and net carrying value of IPR&D as follows:
| Amounts | |
|---|---|
| Balance at December 31, 2023 | $3,017 |
| Impairment of IPR&D | (757) |
| Balance at December 31, 2024 | $2,260 |
The Company completed its impairment test for IPR&D during the fourth quarter of 2024, which resulted in partial impairment of the Company’s $757 of IPR&D. The IPR&D impairment is reflected in impairment charge of goodwill and other intangible assets in the Company’s consolidated statements of operations and comprehensive loss for the year ended December 31, 2024. The Company did not record an IPR&D impairment charge during the year ended December 31, 2023.
Note 8 –Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities, summarized by major category, consist of the following for years ended December 31, 2024 and 2023:
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Severance | $1,509 | $1,176 |
| General and administrative expenses | 292 | 196 |
| Research and development expenses | — | 75 |
| Total | $1,801 | $1,447 |
Note 9 –Leases
The Company has various lease agreements including leases of office space, a laboratory and manufacturing facility, and various equipment. Some leases include purchase, termination or extension options for one or more years. These options will be included in the lease term when it is reasonably certain that the option will be exercised. Certain of the Company’s lease agreements contain rent escalation clauses.
Operating and finance leases are presented in the Company’s consolidated balance sheets as right-of-use assets from leases, current lease liabilities and long-term lease liabilities. The assets and liabilities from our leases are recognized at the lease commencement date based on the present value of remaining lease payments over the lease term using the Company’s incremental borrowing rates or implicit rates, when readily determinable. Short-term leases, which have an initial term of 12 months or less, are not recorded on the balance sheet. As the Company’s operating leases do not provide implicit rates, the Company has utilized its incremental borrowing rate, determined based on the long-term borrowing costs of companies with similar credit profiles, to record its lease obligations. The Company’s finance leases provide readily determinable implicit rates. For operating leases, the Company recognizes the minimum rental expense on a straight-line basis based on the fixed components of a lease arrangement. The Company will amortize this expense over the term of the lease beginning with the lease commencement date.
Operating lease obligations
On November 1, 2013, the Company entered into a 7-year lease for office space in Bedminster, New Jersey which commenced in June 2014 at a monthly rent of approximately $13, increasing to approximately $14 toward the end of the term. The lease was subsequently amended, including most recently on September 13, 2022 to provide additional space and to extend the term of the lease until June 30, 2029 at a monthly rent of approximately of approximately $20, increasing to approximately $23 toward the end of the term. There is no renewal option, no security deposit, no residual value or significant restrictions or covenants other than those customary in such arrangements. Except as expressly provided, all other terms, covenants, conditions and agreements as set forth in the lease will remain unchanged and in full force and effect.
On December 15, 2016, the Company entered into a 10-year, 3-month lease of laboratory and manufacturing space in Bridgewater, New Jersey. The lease began August 2017. The monthly rent started at approximately $43, increasing to approximately $64 in the final year. To obtain the lease, the Company provided an initial security deposit of $586 which was subsequently reduced and is currently $200 at December 31, 2024.
The Company incurred lease expense for its operating leases of $902 for the years ended December 31, 2024 and 2023, respectively. The Company incurred amortization expense on its operating lease right-of-use assets of $602 and $548 for the years ended December 31, 2024 and 2023, respectively.
Finance Leases
The Company incurred interest expense on its finance leases of $2 and $3 for the years ended December 31, 2024 and 2023, respectively. The Company incurred amortization expense on its finance lease right-of-use assets of $5 and $8 for the years ended December 31, 2024 and 2023, respectively.
The following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and finance leases as of December 31, 2024:
| Maturity of Lease Liabilities | Operating Lease Liabilities | Finance Lease Liabilities |
|---|---|---|
| 2025 | $998 | $7 |
| 2026 | 1,040 | 7 |
| 2027 | 944 | 7 |
| 2028 | 273 | — |
| 2029 | 138 | — |
| Total undiscounted operating lease payments | $3,393 | $21 |
| Less: Imputed interest | 516 | 4 |
| Present value of operating lease liabilities | $2,877 | $17 |
| Weighted average remaining lease term in years | 3.3 | 2.9 |
| Weighted average discount rate | 9.3% | 11.6% |
The following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and finance leases as of December 31, 2023:
| Maturity of Lease Liabilities | Operating Lease Liabilities | Finance Lease Liabilities |
|---|---|---|
| 2024 | $956 | $7 |
| 2025 | 998 | 7 |
| 2026 | 1,040 | 7 |
| 2027 | 944 | 7 |
| 2028 | 273 | — |
| Thereafter | 138 | — |
| Total undiscounted operating lease payments | $4,349 | $28 |
| Less: Imputed interest | 816 | 5 |
| Present value of operating lease liabilities | $3,533 | $23 |
| Weighted average remaining lease term in years | 4.3 | 3.9 |
| Weighted average discount rate | 9.2% | 11.6% |
Impairment of right-of-use assets
During the fourth quarter of 2024, the Company determined that the net book value of Bridgewater facility lease right-of-use asset might not be recoverable, primarily due to the terminated partnership negotiations for the future development and commercialization of MAT2203 and subsequent cost-cutting measures. The Company conducted a recoverability test by comparing the projected undiscounted future cash flows associated with the right-of-use asset to its carrying amount and concluded that an impairment charge must be recognized. The charge was subsequently determined based on the excess of the carrying amount of the asset over its estimated fair value. The Company recorded impairment charges related to its Bridgewater facility lease right-of-use asset of $782, and a related finance lease of right-of-use asset of $8. The lease impairment charges were included in the impairment charges of other assets line in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2024. The Company did not record an impairment charge during the year ended December 31, 2023.
Note 10 –Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements
BioNTech Research Collaboration
On April 8, 2022, the Company entered into the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform. Under the terms of the BioNTech Agreement, the Company received an exclusivity fee in the amount of $2,750, and BioNTech SE will fund certain of the Company’s research expenses to be incurred under the agreement. The term of the agreement began on the effective date and expired on April 8, 2023.
The Company assessed the BioNTech Agreement under ASC 808Collaboration Arrangements and ASC 606Revenue from Contracts with Customers(“ASC 606”) and concluded that the contract counterparty, BioNTech SE, is a customer based on the arrangement structure. The Company identified two material promises to deliver under the contract: (1) grant of an exclusive research license and (2) clinical research services. However, given the nature of the promises, the license and research services are not considered to be distinct from each other within the context of the contract. The Company therefore concluded that there is one combined performance obligation for both the license and research services.
The $2,750 license fee was recorded as deferred revenue and was recognized over the term of the contract performance obligation period, which the Company concluded to be 12 months after the execution of the contract. The clinical research services were invoiced as service revenue was earned on a monthly basis during the term of the contract.
For the year ended December 31, 2023, $688 of the contract research revenue was recognized from the license fee and $375 was earned from the monthly clinical research services performed by the Company. As of December 31, 2023, the Company had recognized all of contract research revenue from the BioNTech Agreement.
Cystic Fibrosis Foundation Therapeutics Development Award
On November 19, 2020, the Company entered into an award agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (“CFF”), pursuant to which it received a Therapeutics Development Award of up to $4,234 (the “Award”) (of which $484 had been previously received) to support the preclinical development (the “Development Program”) of the Company’s MAT2501 product candidate. On November 19, 2021, the Company and CFF entered into an Amendment to the CFF Agreement which added an additional milestone payment in the amount of $321.
As of December 31, 2023, the Company has received $3,635 of the $4,555 commitment, inclusive of the Amendment’s additional milestone payment, and a related deferred liability balance of $88 is included in accrued expenses at December 31, 2022. During the year ended December 31, 2023, the Company recognized $88, as credits to research and development expenses related to the CFF award. During the fourth quarter of 2022, for financial and technical reasons, the Company determined that it was not commercially reasonable to continue the development of MAT2501 and instead elected to focus existing resources on other initiatives. As a result, the Company does not anticipate receiving the balance of the commitment and has no further obligations to CFF.
Genentech Feasibility Study Agreement
On December 12, 2019, the Company entered into the Genentech Agreement which involves the development of oral formulations using the Company’s LNC Platform. Under the terms of the Genentech Agreement, Genentech paid the Company a total of $100 for the development of three molecules, or approximately $33 per molecule, which is being recognized upon the Company fulfilling its obligations for each molecule under the Genentech Agreement. The Company recorded the upfront consideration as deferred revenue, which is included in accrued expenses on the consolidated balance sheets. As of December 31, 2022, the Company completed its obligations related to the first and second of the three molecules. During the year ended December 31, 2023, the Company completed its obligations related to the remaining molecule.
License Agreement
Through the acquisition of Aquarius, the Company acquired a license from Rutgers University, The State University of New Jersey (successor in interest to the University of Medicine and Dentistry of New Jersey) for certain patents related to the LNC Platform (the “License Agreement”). The Second Amended and Restated Exclusive License Agreement provides for, among other things, the payment of (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales milestone fee of $100 when and if sales of products using the licensed technology reach the specified sales threshold and (3) an annual license fee of $50 over the term of the License Agreement. The term of the License Agreement will remain in effect until the expiration of the last-to-expire patent rights licensed or seven and one-half years from the date of the first commercial sale of a licensed product under this agreement, whichever is later.
Note 11 –Commitments
Royalty payment rights
Pursuant to the terms of the Certificate of Designations of Preferences, Rights and Limitations (the “Certificate of Designations”) for our Series A Preferred Stock, the Company may be required to pay royalties of up to $35 million per year. If and when the Company obtains FDA or EMA approval of MAT2203 and/or MAT2501, which we do not expect to occur before 2027, if ever, and/or if the Company generates sales of such products, or receives any proceeds from the licensing or other disposition of MAT2203 or MAT2501, the Company will be required to pay to certain former holders of its Series A Preferred Stock, in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined in the Certificate of Designations), subject in all cases to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Certificate of Designations), subject in all cases to a cap of $10 million per calendar year. The Royalty Payment Rights will expire when the patents covering the applicable product expire, which is currently expected to be in 2033.
Employment agreements
The Company also has employment agreements with certain employees which require the funding of a specific level of payments, if certain events, such as a change in control, termination without cause or retirement, occur.
Other normal business operating agreements
In addition, in the course of normal business operations, the Company enters into agreements with contract service providers to assist in the performance of research and development and manufacturing activities. Expenditures to these third parties represent significant costs in clinical development and may require upfront payments and long-term commitments of cash. Subject to required notice periods and obligations under binding purchase orders, the Company can elect to discontinue the work under these agreements at any time.
The Company is not currently a party to any legal proceedings, and the Company is not aware of any claims or actions pending or threatened against its business. In the future, the Company might from time to time become involved in litigation relating to claims arising from our ordinary course of business.
Note 12 –Impairment Charges
The Company reviews property, plant and equipment and other long-lived assets, including leasehold improvements, for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable in accordance with ASC 360, “Property, Plant and Equipment.”
During the fourth quarter of 2024, the Company identified impairment indicators for certain long-lived assets, primarily due to the terminated partnership negotiations for the future development & commercialization of MAT2203 and subsequent cost-cutting measures.
In accordance with ASC 360-10, long-lived assets that are held and used are tested for impairment at the asset group level, which represents the lowest level for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities. The Company has historically determined that its long-lived assets are sufficiently interdependent to constitute one asset group and performed impairment testing at the reporting unit level. However, the workforce reduction implemented in October 2024 and related pause of product development activities indicates a change in the interdependency of the Company’s cash flows. The Company’s long-lived assets will now be evaluated as three asset groups:
| ● | an asset group including all long-lived assets associated with the development of MAT2203 and not otherwise included in the following two asset groups; |
| ● | an asset group including the ROU asset associated with the Bridgewater facility lease, including the related leasehold improvements; and |
| ● | an asset group including machinery & equipment located at the Bridgewater facility. |
ASC 360-10-35 provides that impairment testing for specific assets should be performed in the following order:
| ● | Test other assets (e.g., accounts receivable, inventory) under applicable guidance and indefinite-lived intangible assets (other than goodwill) under ASC 350-30 |
| ● | Test long-lived assets (asset group) under ASC 360-10 |
| ● | Test goodwill of a reporting unit that includes the aforementioned assets under ASC 350-20 |
Indefinite-lived intangible assets
IPR&D
The Company’s indefinite-lived intangible assets are comprised of in-process research and development (“IPR&D”). For the years ended December 31, 2024 and 2023, the Company assessed IPR&D impairment by performing a quantitative analysis for which involved comparing the fair value of the asset, determined using an income approach which is based on discounted cash flow techniques, to the carrying value of the asset.
During the fourth quarter of 2024, the Company identified impairment indicators for its IPR&D and recorded animpairment charge of $757, which represented the excess of the carrying value of the asset over the calculated fair value. The impairment charge has been included in the Company’s Consolidated Statement of Operations and Comprehensive Loss for the year ended December 31, 2024. The Company did not record an impairment charge of IPR&D during the year ended December 31, 2023.
Goodwill
For the year ended December 31, 2024 and 2023, the Company assessed goodwill impairment by performing a quantitative analysis for its reporting unit. As part of the quantitative review, the Company considered whether its fair value, determined as the price a market participant would be willing to pay in a potential acquisition of the Company, exceeds its carrying value, including goodwill.
During the fourth quarter of 2024, the Company identified impairment indicators for its goodwill and recorded an impairment charge of $1,336, which represented the carrying value of goodwill. The impairment charge has been included in the impairment charges of goodwill line item in the Company’s Consolidates Statement of Operations and Comprehensive Loss for the year ended December 31, 2024. The Company didnot record an impairment charge of goodwill during the year ended December 31, 2023.
Long-lived assets
The recoverability test for the Company’s long-lived assets was performed by comparing the carrying amount of each asset group to its estimated future undiscounted pre-tax cash flows over the remaining useful life of the primary long-lived asset within each group. As a result of this analysis, the Company concluded that the carrying value of the asset group including the ROU asset associated with the Bridgewater facility lease and related leasehold improvements, and the asset group including machinery & equipment located at the Bridgewater facility, were not fully recoverable. The Company determined the fair value of the asset group which includes the ROU asset associated with the Bridgewater facility lease and related leasehold improvements using the discounted cash flow method, considering cash flows associated with a potential sublease of the facility. Significant assumptions used include estimated sublease payments, a period of vacancy before the sublease begins and expenses incurred to facilitate the sublease. The Company determined the fair value of the asset group which includes machinery & equipment at the Bridgewater facility by considering its potential salvage value, determined by estimating a salvage rate of proceeds which could be realized in the sale of equipment to a third party. These analyses led to the recognition of impairment charges totaling $2,338. The impairment charges have been included in the Impairment charges of other assets line item in the Company’s Consolidated Statement of Operations and Comprehensive Loss for the year ended December 31, 2024. The Company did not record an impairment charge of other assets during the year ended December 31, 2023.
The following table provides the total amount of impairment charges of other assets as follows:
| Amounts | |
|---|---|
| Leasehold improvement and equipment (including amounts recorded within prepaid expenses) | $1,546 |
| Operating and finance leases right of use assets | 790 |
| Impairment charges of other assets at December 31, 2024 | $2,338 |
Note 13 –Income Taxes
The Company utilizes the liability method of accounting for deferred income taxes. Under this method, deferred tax liabilities and assets are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. A valuation allowance is established against deferred tax assets when, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2024 and 2023, the Company does not believe any material uncertain tax positions were present. Accordingly, interest and penalties have not been accrued due to an uncertain tax position.
The components of the income tax provision are as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Current expense (benefit): | ||
| Federal | $— | $— |
| State | 4 | — |
| Foreign | — | — |
| Total current expense (benefit): | $4 | $— |
| Deferred expense (benefit): | ||
| Federal | $(84) | $— |
| State | — | — |
| Foreign | — | — |
| Total deferred expense (benefit): | $(84) | $— |
| Total income tax expense (benefit): | $(80) | $— |
Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Income at U.S. Statutory Rate | 21.00% | 21.00% |
| State Taxes, net of Federal benefit | 6.53% | 7.91% |
| Permanent Differences | (1.87)% | (1.20)% |
| Tax Credits | 0.00% | 2.49% |
| Valuation Allowance | (25.35)% | (30.20)% |
| Discrete Items | 0.02% | 0.00% |
| Effective income tax rate | 0.33% | 0.00% |
The Company has no current income taxes payable other than certain state minimum taxes which are included in general and administrative expenses. The $80 income tax benefit recognized during the year ended December 31, 2024, primarily relates to a reduction in the deferred tax liability associated with the Company’s IPR&D, which was impaired during the year.
Significant components of the Company’s deferred tax assets (liabilities) for 2024 and 2023 consist of the following:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Share-based Compensation | $5,282 | $5,383 |
| Depreciation and Amortization | 451 | (23) |
| Accrued Liability | 279 | 307 |
| Net Operating Loss Carry-forwards | 28,270 | 25,146 |
| R&D Credit Carryforwards | 4,469 | 4,432 |
| R&D Section 174 Costs | 7,511 | 5,953 |
| Other | 31 | 1 |
| IPR&D | (637) | (851) |
| ROU Asset | (476) | (870) |
| ROU Liability | 811 | 996 |
| Total Deferred tax assets | $45,991 | $40,474 |
| Valuation allowance | (46,248) | (40,815) |
| Net deferred tax asset (liability) | $(257) | $(341) |
In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible, and is impacted by the Company’s ability to carryforward losses to years in which the Company has taxable income. Due to the Company’s history of losses and lack of other positive evidence to support taxable income, the Company has recorded a valuation allowance against those deferred tax assets that are not expected to be realized. The valuation allowances were $46,248, $40,815 and $34,388 as of December 31, 2024, 2023 and 2022, respectively, representing increases of $5,433 and $6,427 for the years ending December 31, 2024 and 2023, respectively.
As of December 31, 2024, the Company had Federal net operating loss carryforwards of $38,080 which will begin to expire in 2032. In addition, the Company has federal net operating loss carryforwards of $88,364 which have an indefinite carryforward period. The Company also had federal and state research and development tax credit carryforwards of $4,469. The federal net operating loss and tax credit carryforwards will expire at various dates beginning in 2032, if not utilized. The difference between the statutory tax rate and the effective tax rate is primarily attributable to the valuation allowance offsetting deferred tax assets.
Utilization of the net operating losses and general business tax credits carryforwards may be subject to a substantial limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to changes in ownership of the Company that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating losses and general business tax credits carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. The Company has not completed a study to determine whether it had undergone an ownership change since the Company’s inception.
Under the Tax Cuts and Jobs Act of 2017, research and development costs are no longer fully deductible and are required to be capitalized and amortized for U.S. tax purposes effective January 1, 2022. The mandatory capitalization requirement increases our deferred tax assets.
Sale of net operating losses (NOLs) & tax credits
The Company recognized $0 and $484 for the years ended December 31, 2024 and 2023, respectively, in connection with the sale of certain State of New Jersey Net Operating Losses (“NOL”) and Research and Development (“R&D”) tax credits to a third party under the New Jersey Technology Business Tax Certificate Transfer Program. In addition, the Tax Cuts and Jobs Act, signed into law on December 22, 2017 imposes significant additional limitations on the deductibility of interest and limits NOL deductions to 80% of net taxable income for losses arising in taxable years beginning after December 31, 2017.
Note 14 –Stockholders’ Equity
Common Stock
Reverse Stock Split
On August 30, 2024, the Company effected the Reverse Stock Split. Accordingly, each of the Company’s stockholders received one share of the Company’s common stock for every 50 shares of the Company’s common stock that such stockholder held immediately prior to the effective time of the Reverse Stock Split. The Reverse Stock Split affected all of the Company’s issued and outstanding shares of common stock equally provided that no fractional shares of common stock were issued as a result of the Reverse Stock Split as fractional shares of common stock were rounded up to the nearest whole share. The Reverse Stock Split also affected the Company’s outstanding stock-based awards, warrants and other exercisable or convertible securities and resulted in the shares of common stock underlying such instruments being reduced and the exercise price or conversion price being increased proportionally by the Reverse Stock Split ratio.
As a result of the Reverse Stock Split, the number of shares of common stock authorized for issuance was adjusted from 500,000,000 to 250,000,000, and the par value of $0.0001 per share was not affected. Additionally, the number of issued and outstanding shares of the Company’s common stock was adjusted from 250,816,164 shares to 5,086,985 shares on August 30, 2024, including the issuance of an additional 70,661 shares to those stockholders that would otherwise would have been entitled to a fractional share of common stock as a result of the Reverse Stock Split.
April 2024 Purchase Agreement
During the year ended December 31, 2024, the Company sold 671,033 shares of its common stock. On April 5, 2024, the Company closed a registered direct offering of 666,667 shares of its common stock and warrants to purchase up to an aggregate of 666,667 additional shares of common stock, at a combined purchase price of $15.00 per share and accompanying warrant. The Company generated gross proceeds of $10,000 and net proceeds of $9,125, after deducting underwriting discounts and commissions and other offering expenses.
At-The-Market Equity Offering
On July 2, 2020, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with BTIG, LLC (“BTIG”), pursuant to which the Company may offer and sell, from time to time, through BTIG, as sales agent and/or principal, shares of its common stock having an aggregate offering price of up to $50,000, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the Sales Agreement. BTIG will be paid a 3% commission on the gross proceeds from each sale. The Company may terminate the Sales Agreement at any time; BTIG may terminate the Sales Agreement in certain limited circumstances. During the year ended December 31, 2024, the Company sold 4,366 shares of its common stock generating net proceeds of $54. The Company didnot sell any shares of its common stock during the year ended December 31, 2023. At December 31, 2024, the Sales Agreement’s available capacity was $44,191.
Preferred Stock
In accordance with the Certificate of Incorporation, the Company is authorized to issue 10,000,000 preferred shares at a par value of $0.001.
Warrants
As of December 31, 2024, the Company had outstanding warrants to purchase 666,667 shares of common stock at an exercise price of $17.50 per share.
The warrants are exercisable six months after issuance date, April 5, 2024, and have a five-and-a-half year term. Once exercisable, the warrants may be exercised at any time in whole or in part upon payment of the applicable exercise price until expiration of the Warrants. No fractional shares will be issued upon the exercise of the Warrants. The exercise price and the number of warrant shares purchasable upon the exercise of the warrants are subject to adjustment upon the occurrence of certain events, which may include stock dividends, stock splits, combination and reclassifications of the Company capital stock or other similar changes to the equity structure of the Company. The warrants do not have a redemption feature. They may be exercised on a cashless basis at the holder’s option and are classified as equity instruments. The warrants to purchase shares of common stock were valued on the date of issuance using the Black-Scholes option pricing model with the following assumptions:
| Expected volatility | 122.66% |
|---|---|
| Risk-free interest rate | 4.38% |
| Stock price on date of grant | $0.30 |
| Exercise price | $0.35 |
| Dividend yield | 0.00% |
| Expected term | 0.5 to 5.5 years |
A summary of warrants outstanding as of December 31, 2024 and 2023 were as follows:
| Shares | |
|---|---|
| Outstanding at December 31, 2022 | 238,000 |
| Issued | — |
| Exercised | — |
| Expired | (238,000) |
| Outstanding at December 31, 2023 | — |
| Issued | 666,667 |
| Exercised | — |
| Expired | — |
| Outstanding at December 31, 2024 | 666,667 |
Note 15 –Accumulated Other Comprehensive Income/(Loss)
The following table summarizes the changes in accumulated other comprehensive income/(loss) by components during the years ended December 31, 2024 and 2023:
| Net Unrealized Gains/(Losses) on Available-for-Sale Securities | Accumulated Other Comprehensive Income/(Loss) | |
|---|---|---|
| Balance, December 31, 2022 | $(824) | $(824) |
| Net unrealized gain on securities available-for-sale | 603 | 603 |
| Balance, December 31, 2023 | $(221) | $(221) |
| Net unrealized gain on securities available-for-sale | 221 | 221 |
| Balance, December 31, 2024 | $— | $— |
All components of accumulated other comprehensive income/(loss) are net of tax.
Note 16 –Stock-based Compensation
The Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”), which expired on May 7, 2024, provided for the granting of incentive stock options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights. There were no significant modifications to the Plan during the years ended December 31, 2024 and 2023. The term of the Plan was for 10 years. The Company intends to adopt a new equity compensation plan at its next Annual Meeting, pending shareholder approval.
As of December 31, 2024, there were 965,678 awards, including both restricted stock grants and option grants, issued and exercised under the Plan and no remaining shares available for grant under the Plan.
The Company recognized stock-based compensation expense (options and restricted share grants) in the following expense categories of its consolidated statements of operations as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and Development | $1,087 | $2,120 |
| General and Administrative | 2,108 | 2,828 |
| Total | $3,195 | $4,948 |
Stock Options
The following table summarizes the Company’ stock option activity and related information for the period from January 1, 2023 to December 31, 2024:
| Number of Options | Weighted Average Exercise Price | Weighted Average Contractual Term in Years | |
|---|---|---|---|
| Outstanding at January 1, 2023 | 694,868 | $53.72 | 7.2 |
| Granted | 278,577 | 12.02 | |
| Exercised | — | — | |
| Forfeited | (5,924) | 31.26 | |
| Expired | (33,278) | 46.91 | |
| Outstanding at December 31, 2023 | 934,243 | $41.67 | 7.4 |
| Granted | — | — | |
| Exercised | — | — | |
| Forfeited | (188,618) | 18.97 | |
| Expired | (58,269) | 56.76 | |
| Outstanding at December 31, 2024 | 687,356 | $46.71 | 4.6 |
The following table summarizes outstanding options at December 31, 2024, by their exercise price:
| Range of Exercise Prices | Number Outstanding | Weighted Average Exercise Price Per Share |
|---|---|---|
| $10.44 - $34.65 | 265,562 | $18.18 |
| $36.34 - $46.00 | 164,500 | $42.94 |
| $46.50 - $62.00 | 95,958 | $53.09 |
| $68.00 - $166.00 | 161,337 | $93.71 |
| 687,357 | $46.71 |
As of December 31, 2024, the number of vested shares underlying outstanding options was 578,707 at a weighted average exercise price of $46.70. None of these outstanding options were in-the-money as of December 31, 2024, therefore they had no intrinsic value. As of December 31, 2024, there was $1,674 of total unrecognized share-based compensation. Such costs are expected to be recognized over a weighted average period of approximately 2.1 years.
All outstanding options expire ten years from date of grant. Options granted to employees prior to 2018 vest in equal monthly installments over three years. Beginning in 2018, options granted to employees vest over four years, with 25% of the shares vesting on the first annual anniversary of grant and the remaining shares vesting in 36 equal monthly installments over the following 3 years.
The resulting compensation expense for stock options is generally recognized on a straight-line basis over the requisite service period of the award. No awards were granted under the Plan during the year ended December 31, 2024. The following weighted-average assumptions were used to calculate share-based compensation for awards granted under the Plan during the year ended December 31, 2023:
| Volatility | 91.2% - 120.5% |
|---|---|
| Risk-free interest rate | 3.50% - 4.69% |
| Dividend yield | 0.0% |
| Expected life | 6.0 years |
The Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior. Hence, the Company uses the “simplified method” described in Staff Accounting Bulletin (SAB) 107 to estimate the expected term of share option grants.
The expected stock price volatility assumption is based on the Company’s historical stock price volatility.
Note 17 –Subsequent Events
On February 13, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain investors (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a private placement (the “Offering”), an aggregate of 3,300 shares of the Company’s Series C Convertible Preferred Stock, par value $0.0001 per share (the “Preferred Stock”), initially convertible into up to 5,631,404 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), with a stated value of $1,000 per share (the “Stated Value”), and warrants (the “Warrants”) to purchase up to an aggregate of 200% of the shares of Common Stock into which the shares of Preferred Stock are initially convertible, or 11,262,808 shares of Common Stock, for an offering price of $1,000 per share of Preferred Stock and accompanying Warrants. The Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing.
Pursuant to the Purchase Agreement, on February 13, 2025, the Company issued and sold in an initial closing of the Offering (the “Initial Closing”),1,650 shares of Preferred Stock, initially convertible into up to 2,815,702 shares of Common Stock, and accompanying Warrants, initially exercisable for up to 5,631,404 shares of Common Stock, for gross proceeds to the Company of $1.65 million. On April 4, 2025, the Company obtained shareholder approval (“Shareholder Approval”) for the issuance of the Preferred Stock and Warrants, as required by the rules and regulations of NYSE American LLC (the “ NYSE”), including Section 713 of the NYSE American Company Guide, and issued and sold, in a second closing of the Offering (the “Second Closing”), an additional 1,650 shares of Preferred Stock, initially convertible into up to 2,815,702 shares of Common Stock, and accompanying Warrants, initially exercisable for up to 5,631,404 shares of Common Stock, for gross proceeds to the Company of $1.65 million.
Under the terms of the Securities Purchase Agreement, the Company is prohibited, subject to certain exceptions, from issuing, entering into any agreement to issue, or announcing the issuance or proposed issuance of any shares of common stock or common stock equivalents until November 2025.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.