Eledon Pharmaceuticals, Inc.
For the period ended Dec 31, 2025. Filed Mar 19, 2026.
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FY2025 · Filed Mar 19, 2026
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Notes to Consolidated Financial Statements
Note 1. Description of Business
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company using its immunology expertise in targeting the CD40 Ligand (“CD40L”) pathway to develop therapies to protect transplanted organs and prevent rejection, and to treat amyotrophic lateral sclerosis (“ALS”). The Company’s lead compound in development is tegoprubart, an IgG1, anti-CD40L antibody with high affinity for the CD40L, a well-validated biological target that we believe has broad therapeutic potential. Unless otherwise indicated, references to the terms “Eledon,” “our,” “us,” “we,” or the “Company” refer to Eledon Pharmaceuticals, Inc. and its wholly owned subsidiaries, on a consolidated basis.
On September 14, 2020, Eledon acquired Anelixis Therapeutics, Inc. (“Anelixis”), a privately held clinical stage biotechnology company developing a next generation anti-CD40L antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases. The Company maintains its corporate headquarters in Irvine, California and has research and development facilities in Burlington, Massachusetts.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Eledon, a Delaware corporation, owns 100% of the issued and outstanding common stock or other ownership interest in Anelixis Therapeutics, LLC, a Delaware limited liability company, and Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”). Otic owns 100% of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The activities of the Company’s foreign subsidiary are not significant to the consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated in consolidation.
Reclassifications
Certain reclassifications have been made to the prior year balances in Note 5. Prepaid Expenses and Other Current Assets and Note 6. Accrued Expenses and Other Liabilities to conform to the current year presentation. These reclassifications had no impact on prior period results.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to stock-based compensation expense, warrant liabilities, the fair value of right-of-use (“ROU”) assets and liabilities, accruals for liabilities, impairment of long-lived assets, and other matters that affect the consolidated financial statements and related disclosures. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements.
Concentration of Credit Risk
Financial instruments which potentially subject the Company to significant concentration of credit risk consists of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured institutions in excess of federally insured limits and invests in short-term investments with the primary objective of seeking to preserve principal, achieve liquidity requirements and safeguard invested funds. We believe that the Company is not exposed to significant credit risk due to the financial position of the depository institution in which those deposits are held and the nature, including the credit ratings, of our cash equivalents and short-term investments, but we have not eliminated all credit risk.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities ofthree months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market funds, U.S. government securities and U.S. government agency securities. Cash and cash equivalents are valued at cost, which approximates their fair value due to the short-term maturities of these investments.
Risks and Liquidity
Since inception, the Company devoted substantially all of its resources to its research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. The Company’s net loss for the year ended December 31, 2025 is$45.6 million. As of December 31, 2025, the Company had cash and cash equivalents and short-term investments of$133.3 million, working capital of$117.3 million and an accumulated deficit of$401.2 million. Due to continuing research and development activities, the Company expects to continue to incur net losses into the foreseeable future. In order to continue these activities, the Company will need to raise additional funds through public or private debt and equity financings including the possible issuance of shares of common stock pursuant to the Company’s “at-the-market” equity offering program, and may need to pursue strategic collaboration and licensing arrangements. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors, including, but not limited to, the market demand for the Company’s common stock, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that the Company would be able to raise such additional capital at a price or on terms that are favorable to the Company. If the Company issues equity or convertible debt securities to raise additional funding, its existing stockholders may experience dilution, it may incur significant financing costs, and the new equity or convertible debt securities may have rights, preferences and privileges senior to those of its existing stockholders. If the Company issues debt securities to raise additional funding, it would incur additional debt service obligations, it could become subject to additional restrictions limiting its ability to operate its business, and it may be required to further encumber its assets.
The Company expects that, based on its current operating plans, the Company’s existing cash, cash equivalents and marketable securities will be sufficient to fund its currently planned operations for at least the next 12 months from the filing date of these consolidated financial statements. The Company anticipates it will require additional financing to fund its future operations. Even if the Company believes it has sufficient funds for its current or future operating plans, the Company may seek to raise additional capital if market conditions are favorable or in light of other strategic considerations.
Reportable Segments
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company operates asone operating andone reportable segment, focused on the development of tegoprubart, to develop therapies to protect transplanted organs and prevent rejection, and to treat ALS. The Company’s measure of segment profit or loss is net loss. The CODM is thechief executive officer. The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a consolidated basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions, therapeutic areas and research and development projects that are in line with the Company’s long-term company wide strategic goals. Consistent with this decision-making process, the CODM uses consolidated net income for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The measure of segment assets is reported on the balance sheet as total consolidated assets.
The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’ssingle reporting segment. A reconciliation to the consolidated net loss for the years ended December 31, 2025 and 2024 is included at the bottom of the table below (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Operating expenses: | ||
| Tegoprubart - kidney transplantation programs | $35,994 | $27,452 |
| Tegoprubart - other development programs | $(168) | 306 |
| Manufacturing | $14,974 | 12,448 |
| Personnel-related expenses | $14,526 | 10,706 |
| Stock-based compensation | $10,451 | 13,122 |
| Other segment items* | $7,474 | 6,543 |
| Other income, net | $4,220 | 3,924 |
| Change in fair value of warrant liabilities | $33,449 | 30,900 |
| Provision for income taxes | $(35) | (431) |
| Net loss | $(45,617) | $(36,184) |
- Other segment items included in total operating expenses primarily consist of consulting, professional fees, facilities, insurance and information technology.
In-Process Research and Development
Amounts allocated to in-process research and development (“IPR&D”) in connection with a business combination are recorded at fair value and are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. If and when development is complete, which generally occurs when regulatory approval to market a product is obtained, the associated assets are deemed finite-lived and amortized over a period that best reflects the economic benefits provided by these assets. During the period the assets are considered indefinite-lived, they will not be amortized but will be tested annually for impairment or more frequently if indicators of impairment exist.
The Company first assesses qualitative factors to determine whether it is more likely than not that the fair value of the IPR&D is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative assessment. If, after assessing qualitative factors, the Company determines it is not more likely than not that the fair value is less than its carrying amount, then a quantitative assessment is unnecessary. If the quantitative assessment is deemed necessary, the excess of the carrying value over fair value will be recorded as an impairment. The qualitative assessment focuses on the key inputs, assumptions and rationale utilized in the establishment of the carrying value and related changes since the last quantitative assessment. Based on the results of the Company’s annual qualitative assessment, the Company concluded that it is not more likely than not that IPR&D was impaired for any of the periods presented.
Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed.
The Company contracts with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to its vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. The Company’s accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. These contracts may be terminated by the Company upon written notice and the Company is generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances the Company may be further responsible for termination fees and penalties. The
Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time.
Net Loss Per Share
Basic and diluted net loss per share are calculated using the two-class method in accordance with Accounting Standards Codification (“ASC”) Topic 260, Earnings Per Share. The two-class method allocates undistributed losses to the Company’s outstanding common stock, and the Series X and Series X 1 non-voting convertible preferred stock, $0.001 par value (the “Preferred Stock”), based on each class’s proportionate share of the total weighted-average shares outstanding. Since the Company has never declared dividends, net loss and undistributed losses are equi valent. The process is used for both common stock and Preferred Stock.
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. As the rights and preferences of the Preferred Stock are substantially identical to each other, they are considered a single class of common stock for earnings per share purposes.
For purposes of the diluted net loss per share calculation, incentive stock options, restricted stock units and warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. Basic weighted average shares outstanding for the years ended December 31, 2025 and 2024 include 36,629,572 and 12,443,755 respectively, shares underlying pre-funded warrants to purchase common shares. As the shares underlying these pre-funded warrants can be issued for little consideration (an exercise price per share equal to $0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share.
Employee Benefit Plan
The Company maintains a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code covering all employees who meet eligibility requirements. Participants may contribute a portion of their compensation subject to IRS limitations. The Company provides matching contributions in accordance with the terms of the plan.
The Company recognized expense related to employer contributions to the plan of $0.5 million and $0.3 million for the years ended December 31, 2025 and 2024, respectively.
Stock-Based Compensation
The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on publicly traded biotechnology and pharmaceutical companies with comparable business characteristics, clinical stages of development, and organizational scale, including employee headcount, primarily consisting of companies with Phase II or Phase III clinical programs. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, the Company determined the expected life assumption using the simplified method for stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation.
Restricted Stock Units (“RSUs”) are measured and recognized based on the quoted market price of our common stock on the date of grant.
Income Taxes
Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. We assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. We have provided a valuation allowance on our deferred tax assets as of December 31, 2025 and 2024 because we believe it is more likely than not that a majority of our deferred tax assets will not be realized as of this date.
The Company evaluates the accounting for uncertainty in income tax recognized in its consolidated financial statements and determines whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit is recorded in its consolidated financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Where applicable, associated interest and penalties are also recorded. The Company has not accrued any liabilities for any such uncertain tax positions as of December 31, 2025 and 2024. The Company is subject to U.S. federal and state tax authority examinations for all the years since inception due to net operating loss and tax credit carryforwards. The net operating losses and tax credits are subject to adjustment until the statute closes on the year the attributes are ultimately utilized.
The Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of the Company’s tax liabilities involves dealing with uncertainties in the application of complex tax regulations. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcomes of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company continually assesses the likelihood and amount of potential revisions and adjusts the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. For additional information, see Note 8. Income Taxesof the Notes to Financial Statements.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted into law. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act 2017, including 100% bonus depreciation and immediate expensing of domestic research and development costs, among other tax changes. The Company had no impact on its consolidated financial statements as a result of the enactment of OBBBA.
Common Stock Warrants and Pre-Funded Warrants
The Company accounts for issued common stock warrants and pre-funded warrants either as a liability or equity in accordance with ASC 480-10, Distinguishing Liabilities from Equity (“ASC 480-10”) and ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity (“ASC 815-40”). The Company first evaluates the warrants under ASC 480-10 to determine whether the instruments should be classified as liabilities, including whether the warrants embody an obligation to repurchase the Company's shares, require or may require cash settlement, or represent obligations to issue a variable number of shares with a monetary value that is fixed or indexed to something other than the Company's stock. If liability classification is not required under ASC 480-10, the Company then applies ASC 815-40. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations and comprehensive loss as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.
Recent Adopted Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-09, effective December 31, 2025, in these consolidated financial statements. ASU 2023-09 only impacted the disclosures and didnot impact the consolidated financial statements. See Note 8, Income Taxes, for disclosures related to the adoption of ASU 2023-09.
Recent Accounting Pronouncements Issued But Not Adopted
In November 2024, the FASB issued ASU No. 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) Disaggregation of Income Statement Expenses,” which requires disaggregated disclosure of income statement expenses for public business entities (“PBEs”). In January 2025, the FASB issued ASU No. 2025-01 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40),” which clarified the effective date for ASU 2024-03. These amendments are intended to provide more information about types of expenses in commonly presented expense captions. The amendments in this update are effective for annual periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, and early adoption is permitted. The Company is currently evaluating the impact on its consolidated financial statements and related disclosures.
Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not believed by management to, have a material impact on the Company’s present or future financial position, results of operations or cash flows.
Note 3. Short-Term Investments
The objectives of the Company’s investment policy are to preserve principal, meet the Company's liquidity requirements and safeguard invested funds. Short-term investments consist of U.S. treasuries and U.S. government securities. The Company has classified these investments as available-for-sale securities, as the sale of such investments may be required prior to maturity to implement management strategies, and therefore has classified all investments with maturity dates beyond three months at the date of purchase as current assets in the accompanying consolidated balance sheets. Any premium or discount arising at purchase is amortized and/or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument. The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. Investments are reported at their estimated fair value. Unrealized gains and losses are included in accumulated other comprehensive loss as a component of stockholders' equity until realized.
The following is a summary of short-term investments, which were classified as available-for-sale securities as of December 31, 2025 and 2024 (in thousands):
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| U.S. treasuries | $59,839 | $27 | $(5) | $59,861 |
| U.S. government securities | 50,667 | 9 | (9) | 50,667 |
| Total short-term investments | $110,506 | $36 | $(14) | $110,528 |
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
| U.S. government securities | $119,603 | $55 | $(29) | $119,629 |
| Total short-term investments | $119,603 | $55 | $(29) | $119,629 |
All of the Company's available-for-sale securities have a stated maturity of less than one year.
Note 4. Fair Value Measurements
Financial assets and liabilities are recorded at fair value.
The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
Level 1—Quoted market prices (unadjusted) in active markets for identical assets and liabilities.
Level 2—Observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active or other inputs that are observable or can be corroborated by observable market data.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. These fair values are obtained from independent pricing services which utilize Level 1 and Level 2 inputs.
Financial Assets
The following table summarizes the Company's financial asset instruments measured at fair value on a recurring basis as of December 31, 2025 and 2024 (in thousands). Included within cash and cash equivalents on the consolidated balance sheets, but excluded from the fair value hierarchy table, are cash deposits held at financial institutions.
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $6,734 | $— | $— | $6,734 |
| U.S. treasuries | — | 14,955 | — | 14,955 |
| Total cash equivalents | 6,734 | 14,955 | — | 21,689 |
| Short-term investments: | ||||
| U.S. treasuries | — | 59,861 | — | 59,861 |
| U.S. government securities | — | 50,667 | — | 50,667 |
| Total short-term investments | — | 110,528 | — | 110,528 |
| Total financial assets | $6,734 | $125,483 | $— | $132,217 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $1,215 | $— | $— | $1,215 |
| U.S. treasuries | — | 17,464 | — | 17,464 |
| Total cash equivalents | 1,215 | 17,464 | — | 18,679 |
| Short-term investments: | ||||
| U.S. government securities | — | 119,629 | — | 119,629 |
| Total short-term investments | — | 119,629 | — | 119,629 |
| Total financial assets | $1,215 | $137,093 | $— | $138,308 |
Warrant Liabilities
The following table summarizes the Company's warrant liabilities(see Note 9. Preferred Stock and Stockholders' Equity) measured at fair value on a recurring basis as of December 31, 2025 and 2024 (in thousands) and was based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy.
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Warrant liabilities | $— | $— | $11,416 | $11,416 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Warrant liabilities | $— | $— | $44,865 | $44,865 |
The following table provides a roll-forward of the aggregate fair value of the warrant liabilities categorized with Level 3 inputs (in thousands):
| Warrant Liability | |
|---|---|
| Balance as of December 31, 2024 | $44,865 |
| Change in fair value of warrant liabilities | (33,449) |
| Settlement of warrant liability | — |
| Balance as of December 31, 2025 | $11,416 |
Note 5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of December 31, 2025 and 2024 (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Prepaid clinical | $578 | $1,768 |
| Interest income receivable | 514 | 625 |
| Prepaid insurance | 688 | 693 |
| Prepaid other | 221 | 215 |
| Prepaid manufacturing | 340 | 147 |
| Other current assets | 11 | 104 |
| Total prepaid expenses and other current assets | $2,352 | $3,552 |
Note 6. Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following as of December 31, 2025 and 2024 (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Accrued clinical | $6,531 | $3,021 |
| Accrued compensation and related expenses | 4,176 | 1,601 |
| Accrued manufacturing | 2,525 | 621 |
| Accrued professional services | 495 | 140 |
| Accrued other | 632 | 47 |
| Total accrued expenses and other liabilities | $14,359 | $5,430 |
Note 7. Commitments and Contingencies
Contract Obligations
As of December 31, 2025, the Company has non-cancelable purchase obligations related to manufacturing totaling $9.3 million. The Company expects to fulfill its commitments within the next twelve months under these agreements in the normal course of business, therefore, no related liability has been recorded on the consolidated balance sheets as of that date.
Operating Leases
The Company leases office space under various operating leases. Total rent expense for all operating leases in the consolidated statements of operations and comprehensive loss was $0.4 million for each of the years ended December 31, 2025 and 2024.
On April 19, 2024, the Company entered into a 38-month operating lease for 5,817 square feet of office space in Irvine, California, that expires on June 30, 2027 (the “Irvine Lease Agreement”). On April 19, 2024, in conjunction with the Irvine Lease Agreement, the Company terminated an existing operating lease for 5,197 square feet of office space in Irvine, California, that was set to expire on December 31, 2024. On April 19, 2024, the effective date of the Irvine Lease Agreement, the Company recognized additional net ROU assets and lease liabilities in the amount of $0.5 million.
On September 4, 2024, the Company entered into a 36-month operating lease for 6,138 square feet of office space in Burlington, Massachusetts, that expires on November 21, 2027 (the “Burlington Lease Agreement”). The prior lease expired on November 20, 2024. On November 21, 2024, the effective date of the Burlington Lease Agreement, the Company recognized additional net ROU assets and lease liabilities in the amount of $0.5 million.
The Company determines if a contract contains a lease at inception. Our office leases have a remaining term of approximately 2 years and do not include options to extend the leases for additional periods.
Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities as adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets. To determine the present value of lease payments not yet paid, we estimate incremental secured borrowing rates corresponding to the maturities of the leases. As we haveno outstanding debt nor committed credit facilities, secured or otherwise, we estimate this rate based on prevailing financial market conditions, comparable company and credit analysis, and management’s judgment.
Our leases contain rent escalations over the lease term. We recognize expense for these leases on a straight-line basis over the lease term. Additionally, tenant incentives used to fund leasehold improvements are recognized when earned and reduce our ROU asset related to the lease. These are amortized through the ROU asset as reductions of expense over the lease term. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants.
While we do not currently have any lease agreement with lease and non-lease components, we elected to account for lease and non-lease components as separate components.
We have elected the short-term lease recognition exemption for all applicable classes of underlying assets. Short-term disclosures include only those leases with a term greater than one month and 12 months or less, and expense is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less, that do not include an option to purchase the underlying asset that we are reasonably certain to exercise, are not recorded on the consolidated balance sheet.
The components of lease expense were as follows (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Operating lease cost(a) | $394 | $407 |
| (a) Includes variable operating lease expenses, which are immaterial. | ||
Other supplemental cash flow information related to leases were as follows (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash paid for amounts included in the measurement of lease liability: | ||
| Operating cash flows from operating leases | $391 | $378 |
Other supplemental balance sheet information related to our operating leases (in thousands, except lease term and discount rate):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Operating leases | ||
| Operating lease right-of-use assets | $613 | $926 |
| Operating lease liabilities (current) | (358) | (314) |
| Operating lease liabilities (non-current) | (283) | (640) |
| Total lease obligations under operating leases | $(641) | $(954) |
| Weighted-average remaining lease term (in years) | 1.7 | 2.7 |
| Weighted-average discount rate | 9.44% | 9.46% |
As of December 31, 2025, future minimum payments under non-cancelable operating leases, were as follows (in thousands):
| Year EndedDecember 31, | |
|---|---|
| 2026 | $403 |
| 2027 | 294 |
| Total minimum lease payments | 697 |
| Less imputed interest | (56) |
| Present value of lease liabilities | 641 |
| Less current portion of operating lease liabilities | (358) |
| Non-current operating lease liabilities | $283 |
Grants and Licenses
ALS Therapy Development Foundation, Inc. License Agreement
In May 2015, Anelixis executed a License Agreement (the “Agreement”), which is an exclusive patent rights agreement with ALS Therapy Development Foundation, Inc. (“ALS TDI”) for certain patents and “know-how” of ALS TDI. This Agreement continues until the licensee terminates the agreement with ninety days written notice. The Agreement requires license fees payable to ALS TDI, subject to the achievement of certain milestones and other conditions.
The first and second milestones of the Agreement are the dosing of the first subjects in a first toxicity study in non-human primates and the dosing of the first patient in a Phase I Clinical Trial, respectively. Both of these milestones were achieved prior to 2024. The fee due upon achievement of each milestone was $1.0 million, and as the payments became due, the Company settled the obligations through the issuance of common stock in lieu of cash payments.
The Agreement was amended and restated in February 2020, and a first amendment to the restated license agreement was executed in September 2020. As amended in September 2020, the remaining milestone payments for a first licensed product total $6.0 million. In the event that the Company develops a second licensed product, the Company is obligated to pay up to $2.5 million in additional milestone payments.
In addition to the milestone payments, the Company is required to pay ALS TDI an amended annual license maintenance fee of $0.1 million beginning on the earlier of January 1, 2022, the Company’s first sublicense, or change in control, as defined in the Agreement. The Company has made a $0.1 million annual license maintenance fee each year since 2022.
Furthermore, the Company is required to pay ALS TDI fees based on reaching certain levels of annual net sales of any product produced with the patent rights. A royalty in the low single digits will be due on aggregate net sales. Upon the first calendar year of reaching $500.0 million in aggregate net sales, the Company will be required to pay ALS TDI a one-time milestone payment of $15.0 million. Upon the first calendar year of reaching $1.0 billion in aggregate net sales, the Company is obligated to pay ALS TDI a one-time milestone payment of $30.0 million.
There wereno milestones achieved during the years ended December 31, 2025 or 2024.
Lonza Sales AG Inc. License Agreement
In September 2018, Anelixis executed a License Agreement (the “Lonza Agreement”), which is a manufacturing know-how rights agreement with Lonza Sales AG Inc. (“Lonza”) for the use of certain processes and know-how related to the manufacture of tegoprubart. The Lonza Agreement continues until the later of the last Valid Claim (as defined therein) or ten years from the First Commercial Sale of tegoprubart, as defined and subject to the conditions therein. A royalty in the low single digits will be due on aggregate net sales of tegoprubart that is manufactured by Lonza or any other third-party or licensee. For the years ended December 31, 2025 and 2024, the Company hasnot paid any royalties under the Lonza Agreement.
Legal Matters
The Company and its subsidiaries are not a party to or the subject of any claim or lawsuit that individually or in the aggregate is anticipated to have a material effect on the Company’s results of operations, financial condition or cash flows.
Indemnifications
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future because of these indemnification obligations. No amounts associated with such indemnifications have been recorded to date.
Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There have beenno contingent liabilities requiring accrual at December 31, 2025 and 2024.
Note 8. Income Taxes
Loss before income taxes are as follows (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Losses before income taxes: | ||
| U.S. | $(45,781) | $(35,951) |
| Non-U.S. | 199 | 198 |
| Total | $(45,582) | $(35,753) |
The provision for income taxes are as follows (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Current: | ||
| Federal | $— | $— |
| State | 30 | — |
| Foreign | — | — |
| Total current income tax provision | 30 | — |
| Deferred: | ||
| Federal | — | — |
| State | 5 | 431 |
| Foreign | — | — |
| Total deferred income tax provision | 5 | 431 |
| Total provision for income taxes | $35 | $431 |
Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis, and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting.
Based on its review, the Company concluded that it was more likely than not that they would not realize the benefit of a portion of its deferred tax assets in the future. This conclusion was based on historical and projected operating performance, as well as the Company’s expectation that its operations will not generate sufficient taxable income in future periods to realize the tax benefits associated with the deferred tax assets within the statutory carryover periods. Therefore, the Company has a valuation allowance on its deferred tax assets as of December 31, 2025.
The Company will continue to assess the need for a valuation allowance on its deferred tax assets by evaluating both positive and negative evidence that may exist. Any adjustment to the net deferred tax asset valuation allowance would be recorded in the statement of operations for the period that the adjustment is determined to be required.
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands):
| $ | % | |
|---|---|---|
| Expected benefit at statutory federal income tax rate | $(9,572) | 21.00% |
| State income taxes, net of federal tax benefits* | 35 | -0.08% |
| Tax credits: | ||
| Research and development credits | (3,512) | 7.70% |
| Nontaxable and nondeductible items: | ||
| Stock-based compensation | 3,574 | -7.84% |
| Other permanent items | 19 | -0.04% |
| Change in fair value of warrant liabilities | (7,024) | 15.41% |
| Changes in unrecognized tax benefits | 1,756 | -3.85% |
| Other | 12 | -0.03% |
| Change in valuation allowance | 14,747 | -32.35% |
| Total provision for income taxes | $35 | -0.08% |
*State taxes in Massachusetts made up the majority (greater than 50%) of the tax effect in this category. The Company paid a majority of cash taxes in Massachusetts.
As previously disclosed for the years ended December 31, 2024, prior to the adoption of ASU 2023-09, the table below is a reconciliation of the components that caused the Company's provision (benefit) for income taxes to differ from amounts computed by applying the U.S. Federal statutory rate of 21% (in thousands):
| Statutory federal income tax rate | $(7,508) |
|---|---|
| State income taxes, net of federal tax benefits | (908) |
| Tax credits | (2,358) |
| Stock-based compensation | 2,819 |
| Permanent items | 12 |
| Change in fair value of warrant liabilities | (7,273) |
| State rate differential | 490 |
| Net operating loss true-up | (4) |
| Other | 24 |
| Change in valuation allowance | 15,137 |
| Total provision for income taxes | $431 |
Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2025 and 2024 consisted of the following (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Net operating loss carryforwards | $29,509 | $22,740 |
| Research and development tax credits | 7,616 | 5,560 |
| Accruals and reserves | 699 | 366 |
| Research expenditures | 28,232 | 18,809 |
| Stock-based compensation | 1,591 | 3,281 |
| Depreciation and amortization | 795 | 1,056 |
| Lease liability | 151 | 225 |
| Total deferred tax assets | 68,593 | 52,037 |
| Right-of-use asset | (144) | (218) |
| Acquired IPR&D | (7,628) | (7,623) |
| Total deferred tax liabilities | (7,772) | (7,841) |
| Less: valuation allowance | (63,008) | (46,379) |
| Net deferred tax liabilities | $(2,187) | $(2,183) |
The following table reconciles the beginning and ending amounts of unrecognized tax benefits for the years presented (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Gross unrecognized tax benefits at the beginning of the year | $6,232 | $3,636 |
| Additions from tax positions taken in the current year | 2,017 | 2,596 |
| Additions from tax positions taken in prior years | 12 | — |
| Prior year adjustment | (238) | — |
| Gross unrecognized tax benefits at the end of the year | $8,023 | $6,232 |
The following table summarizes the income taxes paid, net of refunds, for the year ended December 31, 2025 (in thousands).
| U.S. Federal | $— |
|---|---|
| Massachusetts | 26 |
| Other | 2 |
| Total income taxes paid | $28 |
The deferred income tax assets have been offset by a valuation allowance, as realization is dependent on future earnings, if any, the timing and amount of which are uncertain. The net valuation allowance increased by $16.6 million from December 31, 2024 to December 31, 2025. The net valuation allowance increased by $15.6 million from December 31, 2023 to December 31, 2024.
The Company’s accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of its net deferred tax assets. The Company primarily considered such factors as its history of operating losses, the nature of the Company’s deferred tax assets, and the timing, likelihood, and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible. At present, the Company does not believe that it is more likely than not that the deferred tax assets will be realized; accordingly, a valuation allowance has been established.
As of December 31, 2025 and 2024, the Company had federal net operating loss carryforwards of approximately $117.5 million and$88.7 million, respectively, available to reduce future taxable income. As of December 31, 2025 and 2024, the Company also had state net operating loss carryforwards of $49.1 million and$37.7 million, respectively. Both the federal and state net operating loss carryforwards incurred before 2018 begin expiring in 2035, if not utilized. The federal net operating losses incurred since 2018 of $116.7 million do not expire. The state net operating losses begin to expire in 2035. As of December 31, 2025 and 2024, the Company had Israel net operating losses of $7.9 million, respectively, which carryforward indefinitely.
As of December 31, 2025 and 2024, the Company had federal research and development tax credit carryforwards of approximately $11.5 million and $8.0 million, respectively. If not utilized, the carryforwards will begin expiring in 2035. As of December 31, 2025 and 2024, the Company had state research and development credit carryforwards of approximately $3.4 million and$2.6 million, respectively, which will begin expiring in 2030 if not utilized.
Pursuant to the Internal Revenue Code of 1986, as amended (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within athree-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate.
The Company’s ability to use its remaining net operating loss and tax credit carryforwards may be further limited if the Company experiences an IRC Section 382 ownership change in connection with future changes in our stock ownership.
In the United States, the Company files income tax returns in the U.S. Federal jurisdiction, California and Massachusetts. The Company’s tax years for 2019 and forward are subject to examination by the Federal and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits.
The Company’s policy is to recognize interest expense and penalties related to income tax matters as a component of income tax expense. There wasno accrued interest and penalties associated with uncertain tax positions as of December 31, 2025 and 2024. The Company hasnot recorded any interest or penalties as of December 31, 2025 or 2024.
On July 4, 2025, the OBBBA was signed into law. The legislation includes several changes to federal tax law that generally allow for more favorable deductibility of certain business expenses beginning in 2025, including the restoration of immediate expensing of domestic research and development expenditures, reinstatement of 100%bonus depreciation, and more favorable rules for determining the limitation on business interest expense. OBBBA changes effective for 2025 were determined to have no impact to the income tax provision for year ended December 31, 2025.
Note 9. Preferred Stock and Stockholders’ Equity
Convertible Preferred Stock
The Company has 5,000,000 authorized shares of preferred stock with a par value of $0.001 per share:
Series X 1 non-voting convertible preferred stock,515,000 shares designated;110,086 shares issued and outstanding at December 31, 2025 and 2024, and
Series X non-voting convertible preferred stock,10,000 shares designated;4,422 shares issued and outstanding at December 31, 2025 and 2024.
Each share of Preferred Stock isconvertible into 55.5556 shares of common stock, at the option of the holder at any time, subject to certain limitations, including, that the holder will be prohibited from converting the Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above a conversion blocker, which is initially set at 9.99% or 9.9% of the total common stock then issued and outstanding immediately following the conversion of such shares of Series X Preferred Stock or Series X 1 Preferred Stock, respectively. The holder of the Preferred Stock is entitled to receive dividends on shares of the Preferred Stock equal (on an as-if-converted-to-common-stock basis and without regard to any beneficial ownership limitations) to and in the same form as dividends actually paid on shares of the common stock. No other dividends will be paid on shares of the Preferred Stock. In the event of any liquidation, dissolution or winding up, the holder of the Preferred Stock will be entitled to receive out of the assets, whether capital or surplus, the same amount that a holder of common stock would receive if the Preferred Stock were fully converted to common stock, which amounts shall be paid pari passu with all holders of common stock. Shares of the Preferred Stock will generally have no voting rights, except as required by law and except that the consent of a majority of the holders of either series of outstanding Preferred Stock will be required to amend the terms of such series.
The Preferred Stock includes a provision that, in the event of a tender or exchange offer by a third party in which more than 50% of the common stockholders receive cash or other assets, allows holders of Preferred Stock, upon any subsequent conversion, to redeem their shares for the same form of consideration. In August 2025, the Company concluded that because this redemption right may be triggered by an event outside the Company’s control and could result in settlement in cash, the Preferred Stock is classified as temporary equity. As of the current reporting date, a tender offer is not probable, and the preferred stock is not deemed probable of becoming redeemable. Because redemption is not considered probable, the Preferred Stock is not subsequently remeasured to its redemption value.
Common Stock
On June 10, 2025, the Company held its 2025 Annual Meeting of Stockholders (the “2025 Annual Meeting”). At the 2025 Annual Meeting, the Company’s stockholders approved an amendment (the “Authorized Share Increase Amendment”) to the Company’s Restated Certificate of Incorporation (as amended, the “Certificate of Incorporation”) to increase the number of authorized shares of common stock from 200,000,000 to 300,000,000 shares.
2023 Securities Purchase Agreement
On April 28, 2023, the Company entered into a Securities Purchase Agreement (the “2023 Securities Purchase Agreement”) with certain investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2023 Private Placement”) (i) in an initial closing, (a) an aggregate of 15,151,518 shares (the “Shares”) of the Company’s common stock, $0.001 par value per share (“common stock”), or pre-funded warrants in lieu thereof (the “Pre-Funded Warrants”), and (b) common stock warrants exercisable into an aggregate of 15,151,518 shares of common stock (or Pre-Funded Warrants in lieu thereof) (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”); (ii) in a second closing (the “Second Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 20,202,024 shares of common stock (or Pre-Funded Warrants); and (iii) in a third closing (the “Third Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 25,252,530 sharesof common stock (or Pre-Funded Warrants), in each case subject to customary adjustments as provided in the 2023 Securities Purchase Agreement, Pre-Funded Warrant or Common Warrant, as applicable. Each Common Warrant has an exercise price of $3.00 per share and expires five years after issuance. The Pre-Funded Warrants are exercisable immediately and until exercised in full, with an exercise price of $0.001 per share.
The Pre-Funded Warrants and Common Warrants are subject to specified beneficial ownership limitations, which are generally set at 9.99% of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99% unless otherwise permitted. The Shares, the Warrants, and the shares of common stock issuable upon the exercise of the Warrants, have not been registered under the Securities Act of 1933, as amended (the“Securities Act”), and were offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
On May 5, 2023, the initial closing occurred, and the Company received $35.0 million, or net proceeds of approximately $33.0 million after deducting offering costs, in exchange for 8,730,168 shares of common stock and Pre-Funded Warrants to purchase 6,421,350 shares of common stock.
On July 8, 2024, the Second Closing occurred, and the Company received gross proceeds of $2.1 million, or net proceeds of approximately $2.0 million after deducting offering costs, in exchange for 909,088 shares of common stock.
On September 30, 2024, and October 1, 2024, the Third Closing occurred, and the Company received gross proceeds of $4.0 million, or net proceeds of approximately $3.8 million after deducting offering costs, in exchange for 1,727,400 shares of common stock.
In connection with the 2023 Private Placement, the Company filed on May 18, 2023, a registration statement on Form S-3 (the “2023 Registration Statement”) with the SEC to register for resale the Shares and the shares of common stock issuable upon the exercise of the Warrants. The 2023 Registration Statement became effective on June 2, 2023.
In August 2024, the Company concluded that the Common Warrants, and the potential issuance of Pre-Funded Warrants in lieu of additional shares of common stock in the Second Closing and Third Closing (the “Subsequent Closing Warrants”) do not meet the conditions to be classified as equity instruments under ASC 815-40 and must instead be recorded as liabilities on the Company’s consolidated balance sheets at their fair value and remeasured at fair value for each subsequent reporting period. As of October 2024, the Subsequent Closing Warrants either expired or were settled in connection with the Second Closing and Third Closing. Accordingly, the Company's consolidated balance sheets no longer include any fair value associated with the Subsequent Closing Warrants.
The valuation of the Common Warrants is adjusted to fair value (Level 3) at each balance sheet date until the Common Warrants are settled or expired.
The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of the Common Warrants as of December 31, 2025 and 2024 as follows:
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Expected stock price volatility | 110.5% | 96.4% |
| Risk-free interest rate | 3.6% | 4.4% |
| Expected term (in years) | 2.5 | 3.5 |
| Share price | $1.51 | $4.14 |
2024 Securities Purchase Agreement
On May 6, 2024, the Company entered into a Securities Purchase Agreement (the “2024 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2024 Private Placement”) an aggregate of 13,110,484 shares (the “2024 Shares”) of the Company’s common stock, at a price of $2.37 per share, and pre-funded warrants (the “2024 Pre-Funded Warrants”) at a price of $2.369 per underlying share, which are exercisable to purchase 7,989,516 shares of common stock at an exercise price of $0.001 per share. The 2024 Pre-Funded Warrants were issued in lieu of shares of common stock and are exercisable immediately and until exercised in full. The 2024 Pre-Funded Warrants are subject to specified beneficial ownership limitations (equal to 4.99% or 9.99% as determined by the holders of each such warrant) of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99%unless otherwise permitted. The 2024 Shares, the 2024 Pre-Funded Warrants, and the sharesof common stock issuable upon the exercise of the 2024 Pre-Funded Warrants, have not been registered under the Securities Act and were offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
The 2024 Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital. The 2024 Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the 2024 Pre-Funded Warrants do not provide any guarantee of value or return.
The 2024 Private Placement resulted in gross proceeds to the Company of $50.0 million, or net proceeds of approximately $48.1 million after deducting offering costs. The Company is using the net proceeds from the 2024 Private Placement to fund pre-commercial activities for its products and general corporate purposes.
In connection with the 2024 Private Placement, the Company filed on May 24, 2024, a registration statement on Form S-3 (the “2024 Registration Statement”) with the SEC to register for resale the 2024 Shares and the shares of common stock issuable upon the exercise of the 2024 Pre-Funded Warrants. The 2024 Registration Statement became effective on June 5, 2024.
2024 Equity Distribution Agreement
On September 20, 2024, the Company entered into an Open Market Sale Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”) to sell shares of the Company’s common stock, having aggregate sales proceeds of up to $75.0 million, from time to time, through an “at the market” equity offering program under which Guggenheim Securities will act as sales agent. In connection with the Sales Agreement, the Company filed on September 20, 2024 a registration statement on Form S-3 containing a prospectus and prospectus supplement (the “Shelf Registration Statement”) with the SEC. The Shelf Registration Statement became effective on October 2, 2024. As of theyear ended December 31, 2025, the Company has not sold any shares under the Sales Agreement.
2024 Underwritten Offering
On October 29, 2024, the Company entered into an underwriting agreement with Leerink Partners, LLC, as representative of the several underwriters named therein in connection with the underwritten offering, issuance and sale by the Company (the “2024 Underwritten Offering”) of 18,356,173 shares of the Company’s common stock, at an offering price of $3.65 per share, and pre-funded warrants at a price of $3.649 per pre-funded warrant, which are exercisable to purchase 4,931,507 shares of the Company’s common stock at an exercise price of $0.001 per share (the “2024 Offering Pre-Funded Warrants”).
The 2024 Offering Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital. The 2024 Offering Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the 2024 Offering Pre-Funded Warrants do not provide any guarantee of value or return.
The 2024 Underwritten Offering closed on October 30, 2024 and resulted in gross proceeds of $85 million, or net proceeds of approximately $79.5 million after deducting underwriting discounts and commissions and offering expenses. The 2024 Underwritten Offering was made pursuant to the Shelf Registration Statement and a prospectus supplement relating to the 2024 Underwritten Offering dated October 29, 2024.
A holder of the 2024 Offering Pre-Funded Warrants (together with its affiliates) may not exercise any portion of a 2024 Offering Pre-Funded Warrant to the extent that, after giving effect to such exercise, the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates) would beneficially own in excess of 4.99% (or, at the holder’s option upon issuance,9.99%) of the number of shares of the Company's common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon exercise of such 2024 Offering Pre-Funded Warrant.
2025 Underwritten Offering
On November 12, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners, LLC, as representative of the several underwriters named therein (the “Underwriters”), in connection with the underwritten public offering and sale by the Company (the “2025 Underwritten Offering”) of 15,152,485 shares of the Company’s common stock at a public offering price of $1.65 per share (the “Common Stock Purchase Price”), and pre-funded warrants (the “2025 Offering Pre-Funded Warrants”) at a public offering price of $1.649 per 2025 Offering Pre-Funded Warrant, which are exercisable to purchase up to 15,151,515 shares of common stock at an exercise price of $0.001 per share. In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriters an option (the “Option”), exercisable for 30 days, to purchase up to 4,545,600 additional shares of common stock at the Common Stock Purchase Price less the underwriting discounts and commissions, which Option had been exercised in full by the Underwriters.
The 2025 Underwritten Offering closed on November 13, 2025 and resulted in gross proceeds of $57.5 million or net proceeds of approximately $53.6 million after deducting the underwriting discounts and commissions and offering expenses. The 2025 Underwritten Offering was made pursuant to the Shelf Registration Statement and a prospectus supplement relating to the 2025 Underwritten Offering dated November 12, 2025.
The 2025 Offering Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital. The 2025 Offering Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the 2025 Offering Pre-Funded Warrants do not provide any guarantee of value or return.
A holder of the 2025 Offering Pre-Funded Warrants (together with its affiliates) may not exercise any portion of a 2025 Offering Pre-Funded Warrant to the extent that, after giving effect to such exercise, the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates) would beneficially own in excess of 4.99% of the number of shares of the Company's common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon exercise of such 2025 Offering Pre-Funded Warrant. A holder may increase or decrease such beneficial ownership limitation, provided that in no event shall the limitation exceed 19.99% of the number of shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the 2025 Offering Pre-Funded Warrant.
2025 Warrant Exchange Agreement
On December 30, 2025, the Company entered into an exchange agreement (the “Warrant Exchange Agreement”) with Coastlands Capital Partners LP, (“Coastlands Capital”), pursuant to which Coastlands Capital agreed to exchange 4,203,764 shares of the Company's common stock for a pre-funded warrant to purchase an aggregate of 4,203,764 shares of common stock (the “Exchange Warrant”), and the Company cancelled the 4,203,764 shares of common stock delivered in the exchange.
Coastlands Capital (together with its affiliates) may not exercise any portion of the Exchange Warrant to the extent that, after giving effect to such exercise, Coastlands Capital (together with its affiliates and any other persons acting as a group together with Coastlands Capital or any of the its affiliates) would beneficially own in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon exercise of the Exchange Warrant. Coastlands Capital may increase or decrease such beneficial ownership limitation, provided that in no event shall the limitation exceed 19.99% of the number of shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the Exchange Warrant.
Exercise of Pre-Funded Warrants from 2023 Securities Purchase Agreement
On January 30, 2024, Armistice Capital Master Fund Ltd. (the “Exercising Stockholder”) exercised Pre-Funded Warrants to purchase 600,000 shares of common stock at an exercise price of $0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On January 30, 2024, the Company issued 600,000 shares of common stock to the Exercising Stockholder in accordance with such exercise.
On May 7, 2024, the Exercising Stockholder exercised Pre-Funded Warrants to purchase 583,000 shares of common stock at an exercise price of $0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On May 9, 2024, the Company issued 583,000 shares of common stock to the Exercising Stockholder in accordance with such exercise.
On July 11, 2024, the Exercising Stockholder exercised their remaining Pre-Funded Warrants to purchase 240,000 shares of common stock at an exercise price of $0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On July 11, 2024, the Company issued 240,000 shares of common stock to the Exercising Stockholder in accordance with such exercise.
Common Stock Warrants and Pre-Funded Warrants
As of December 31, 2025,51,781,090 warrants and pre-funded warrants exercisable into common stock. The Company has issued both common stock warrants and pre-funded warrants. The pre-funded warrants are exercisable for shares of common stock at a nominal exercise price and were fully paid for at issuance, except for the nominal exercise amount. The pre-funded warrants are intended to be economically equivalent to the Company’s common stock.
The following table shows the warrants to purchase common stock activity:
| Roll-Forward of Warrant Activity | |||
|---|---|---|---|
| Common Stock Warrants | Pre-Funded Warrants | Total | |
| Balance as of December 31, 2024 | 15,778,451 | 17,274,293 | 33,052,744 |
| Issued | — | 19,355,279 | 19,355,279 |
| Cancelled/Expired | (626,933) | — | (626,933) |
| Balance as of December 31, 2025 | 15,151,518 | 36,629,572 | 51,781,090 |
As of December 31, 2025, the Company's outstanding warrants to purchase shares of common stock consisted of the following:
| Date Issued | Number of Shares of Common Stock Issuable | Exercise Price | Expiration Date |
|---|---|---|---|
| 2023 Securities Purchase Agreement common warrants | 15,151,518 | $3.00 | May 5, 2028 |
| January 2021 pre-funded warrants | 509,117 | $0.001 | December 31, 2030 |
| 2023 Securities Purchase Agreement pre-funded warrants | 3,844,153 | $0.001 | N/A |
| 2024 Securities Purchase Agreement pre-funded warrants | 7,989,516 | $0.001 | N/A |
| 2024 Underwritten Offering pre-funded warrants | 4,931,507 | $0.001 | N/A |
| 2025 Underwritten Offering pre-funded warrants | 15,151,515 | $0.001 | N/A |
| 2025 Warrant Exchange Agreement | 4,203,764 | $0.001 | N/A |
| Balance as of December 31, 2025 | 51,781,090 | ||
Preferred Stock Warrants
As of December 31, 2025, all warrants exercisable for shares of Series X 1 Preferred Stock expired in accordance with their original terms.
| Roll-Forward of Series X1 Convertible Preferred Warrant Activity | |
|---|---|
| Total | |
| Balance as of December 31, 2024 | 50,207.419 |
| Assumed and replaced | — |
| Exercised | — |
| Cancelled/Expired | (50,207.419) |
| Balance as of December 31, 2025 | — |
Note 10. Stock-Based Compensation
Stock Option Plans
The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical industry. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, the Company determined the expected life assumption using the simplified method for stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. For stock options granted to the Company’s board of directors (the “Board”), the Company determined the expected life assumption using the simplified method as the starting point with an average period of 12 months added to take into account the extended range of time of 12 to 18 months that vested stock options granted to Board members may be exercised upon termination. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation.
Restricted Stock Units (“RSUs”) are measured and recognized based on the quoted market price of our common stock on the date of grant.
On July 10, 2024, the Company held its 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”). At the 2024 Annual Meeting, the Company’s stockholders approved an amendment to the Company's 2020 Long Term Incentive Plan (the “2020 Plan”). The 2020 Plan, as amended, (i) reflects an increase in the limit on the aggregate number of shares of the Company’s common stock that may be delivered pursuant to all awards granted under the 2020 Incentive Plan by an additional 3,500,000 shares so that the new aggregate share limit under the 2020 Plan is 17,960,000 shares, and (ii) extends the date through which the Company may grant new awards under the 2020 Plan from November 15, 2030 to April 28, 2034.
On May 1, 2023, the Company issued stock option awards to its employees with both time-based and performance-based vesting requirements, totaling 7,381,857 stock options, with 1,476,372 of the granted stock options subject to the Company’s customary time-based vesting schedule. The remaining 5,905,485 stock options granted are subject to both customary time-based vesting requirements and performance-based vesting requirements that are based on the same clinical development milestones applicable to the Second Closing and Third Closing of the 2023 Private Placement as specified in the 2023 Securities Purchase Agreement.
In December 2023, the Company amended the performance-based vesting requirements with its named executive officers and other employees that upon the Second Closing and Third Closing, a full or prorated amount of each closing installment shall vest based on the percentage of funding received relative to the total funding opportunity represented by the investors’ Second Closing and Third Closing subscription amounts. On June 13, 2024 and November 20, 2024, the performance-based vesting requirement based on the milestones applicable to the Second Closing and Third Closing were satisfied, and 5,763,085 stock options were issued.
The Company's 2014 Stock Incentive Plan (the “2014 Plan”) was closed to new grants following the approval of the 2020 Plan, and therefore, there wereno shares reserved for issuance under the 2014 Plan as of December 31, 2025. The number of shares reserved for issuance under the 2020 Plan and the Company's Employee Stock Purchase Plan was 3,961,166 and 24,077 shares, respectively, as of December 31, 2025.
The following table summarizes all option activity under the 2014 Plan, 2020 Plan and inducement grants, including 2,713,083 shares forfeited by certain Company's executive officers and directors on December 30, 2025:
| SharesIssuableUnder Options | WeightedAverageExercise Price | WeightedAverageRemainingContractualTerm | AggregateIntrinsicValue(in thousands) | |
|---|---|---|---|---|
| (In years) | ||||
| Outstanding as of January 1, 2024 | 15,381,853 | $4.21 | 8.9 | $235 |
| Granted | 622,000 | 2.22 | ||
| Exercised | (50,000) | 2.30 | ||
| Forfeited / Canceled | (316,465) | 7.29 | ||
| Outstanding as of December 31, 2024 | 15,637,388 | $4.02 | 7.5 | $20,628 |
| Granted | 2,495,025 | 4.01 | ||
| Exercised | (100,437) | 2.30 | ||
| Forfeited / Canceled | (2,804,477) | 8.66 | ||
| Outstanding as of December 31, 2025 | 15,227,499 | $3.17 | 7.3 | $357 |
| Options vested and expected to vest as of December 31, 2025 | 15,227,499 | $3.17 | 7.3 | $357 |
| Options exercisable as of December 31, 2025 | 9,189,825 | $3.31 | 6.8 | $179 |
Intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of the common stock for the options that had exercise prices that were lower than the fair value per share of the common stock on the date of exercise. The aggregate intrinsic value of options exercised during the year ended December 31, 2025 was$0.2 million.
The Company estimates the fair value of stock option awards on the grant date using the Black-Scholes option pricing model with the following weighted-average assumptions:
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Expected stock price volatility | 97.8% | 101.3% |
| Risk-free interest rate | 4.5% | 4.2% |
| Expected term (in years) | 6.0 | 6.9 |
| Estimated dividend yield | —% | —% |
The per share weighted average grant date fair value of stock options granted during the years ended December 31, 2025 and 2024 was$3.25 and $1.93, respectively.
Restricted Stock Units
The following table shows the RSU activity, as follows:
| SharesIssuableUnder RSUs | WeightedAverageGrant Date Fair Value | |
|---|---|---|
| Outstanding as of January 1, 2024 | — | $— |
| Granted | 46,000 | 1.97 |
| Exercised | — | — |
| Forfeited / Canceled | — | — |
| Outstanding as of December 31, 2024 | 46,000 | $1.97 |
| Granted | 336,225 | 4.04 |
| RSUs Vested | (46,000) | 1.97 |
| Forfeited / Canceled | — | — |
| Outstanding as of December 31, 2025 | 336,225 | $4.04 |
Stock-based Compensation Expense
Total compensation expense related to all of the Company’s stock-based awards for the years ended December 31, 2025 and 2024 was comprised of the following (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock-based compensation classified as: | ||
| Research and development expense | $4,241 | $4,277 |
| General and administrative expense | 6,210 | 8,845 |
| Total stock-based compensation expense | $10,451 | $13,122 |
As of December 31, 2025, total unrecognized stock-based compensation expense related to non-vested equity awards was $13.8 million, which is expected to be recognized over an estimated weighted-average period of 2.1 years.
Note 11. Net Loss Per Share
Basic and diluted net loss per share are calculated using the two-class method in accordance with ASC Topic 260, Earnings Per Share. The two-class method allocates undistributed losses to the Company’s outstanding common stock, and the Preferred Stock, based on each class’s proportionate share of the total weighted-average shares outstanding. Since the Company has never declared dividends, net loss and undistributed losses are equivalent.
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. The process is used for both common stock and Preferred Stock. As the rights and preferences of the Preferred Stock are substantially identical to each other, they are considered a single class of common stock for earnings per share purposes.
For purposes of the diluted net loss per share calculation, incentive stock options, restricted stock units and common warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Basic weighted average shares outstanding for the years ended and December 31, 2025 and 2024 include 36,629,572 and 12,443,755 respectively, shares underlying pre-funded warrants to purchase common shares. As the shares underlying these pre-funded warrants can be issued for little consideration (an exercise price per share equal to $0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share.
The calculation of basic and diluted earnings per share for our common stock and Preferred Stock is as follows:
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| (In thousands, except share and per share data) | ||
| Weighted-average common shares outstanding, basic and diluted | 81,836,246 | 48,543,787 |
| Weighted-average shares outstanding of Series X and Series X1 non-voting convertible preferred stock, basic and diluted | 114,508 | 114,508 |
| Net loss used in the calculation of basic and diluted loss per share | $(45,617) | $(36,184) |
| Net loss available to common stock | $(42,328) | $(31,992) |
| Net loss per share, common stock, basic and diluted | $(0.52) | $(0.66) |
| Net loss available to Series X and Series X1 non-voting convertible preferred stock | $(3,290) | $(4,192) |
| Basic and diluted earnings per share of Series X and Series X1 non-voting convertible preferred stock | $(28.73) | $(36.61) |
The following table presents potentially dilutive securities outstanding based on the market price of the Company's common stock as of December 31, 2025 and 2024 that were excluded from the computation of diluted net loss per share because their inclusion would have been anti-dilutive. These securities consist of incentive stock options, restricted stock units and common warrants outstanding during the respective periods.
| Year EndedDecember 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options outstanding and other equity awards | 1,333,225 | 6,007,789 |
| Common warrants | — | 18,567,751 |
| Total | 1,333,225 | 24,575,540 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.