Traws Pharma, Inc.
For the period ended Dec 31, 2025. Filed Apr 15, 2026.
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FY2025 · Filed Apr 15, 2026
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Notes to Consolidated Financial Statements
1. Nature of Business
The Company
Traws Pharma, Inc. (“Traws Pharma” or the “Company”), formerly known as Onconova Therapeutics, Inc., was incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The Company's headquarters are located in Newtown, Pennsylvania. On April 1, 2024, the Company acquired Trawsfynydd Therapeutics, Inc., a Delaware corporation (“Trawsfynydd”), through a merger (the “Merger”) and the name change to Traws Pharma was effected. The Company accounted for the transaction as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated intwo programs that were grouped as a single identifiable in-process research and development (“IPR&D”) asset. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Following the Merger, the Company hasfour clinical programs: (i) tivoxavir marboxil, an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza; (ii) ratutrelvir, an inhibitor of the main protease (also known as 3CL protease) of the SAR-CoV-2 virus, the causative agent in COVID-19; (iii) narazaciclib (ON 123300), a multi-targeted kinase inhibitor in solid tumors and hematological malignancies as a single agent or in combination with other anti-cancer therapies; and (iv) rigosertib, administered alone or in combination for investigation in various cancers. The Company’s primary focus is the development of tivoxavir marboxil and ratutrelvir, and its strategic objective for narazaciclib and rigosertib is to establish additional partnerships for further development of the compounds.
Liquidity
The Company has incurred recurring operating losses since inception. As of December 31, 2025, the Company had generated an accumulated deficit of $639,984,000. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates and its preclinical programs, strategic alliances and its administrative organization. At December 31, 2025, the Company had cash and cash equivalents of $3,820,000. Based on current projections, the Company believes that it does not have sufficient cash and cash equivalents to support its operations for more than one year following the date that these financial statements are issued. As a result of these conditions, substantial doubt exists about the Company’s ability to continue as a going concern.
The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. Management plans to explore various dilutive and non-dilutive sources of funding, including equity financings, strategic alliances, business development and other sources. The future success of the Company is dependent upon its ability to obtain additional funding. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on the Company’s business, results of operations and financial condition. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all.
Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biotechnology products, the Company may have based this estimate on assumptions that may prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the Company.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Trawsfynydd Therapeutics LLC, Trawsfynydd Therapeutics AU Ltd, Throxavir Therapeutics AU Pty Ltd, and Onconova Europe GmbH. All significant intercompany transactions have been eliminated.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. 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, the results of which form the basis for making judgments about the carrying value of assets, liabilities, and equity and the amount of revenues and expenses. Actual results could differ significantly from those estimates. The most significant estimates and assumptions that management considers in the preparation of the Company's financial statements relate to prepaid and accrued research and development costs; the valuation of consideration transferred in acquiring the assets of Trawsfynydd; and inputs used in the Black-Scholes model for stock-based compensation expense and Series A Warrant (as defined below) liability.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company hasone operating segment. The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All the Company’s long-lived assets are held in the United States.
Concentrations of Credit Risk and Off-Balance Sheet Risk
Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains a portion of its cash and cash equivalent balances in the form of money market accounts with financial institutions that management believes are creditworthy. The Company hasno financial instruments with off-balance sheet risk ofloss.
At December 31, 2025 the Company had $2,927,000 of its cash and cash equivalents in money market funds that invest in a portfolio of liquid, high-quality debt securities issued by the U.S. government.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original or remaining maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. During the years ended December 31, 2025 and 2024, the Company received $455,000 and $510,000, respectively, of interest income primarily from a money market mutual fund that invests primarily in U.S. government obligations. The interest income is included in Other income, net in the Statement of Operations.
Deferred Financing Costs
The Company capitalizes costs that are directly associated with in-process equity and debt financing until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred financing costs are expensed.
Asset Acquisitions
Acquisitions of assets or a group of assets that do not meet the definition of a business are accounted for as asset acquisitions, with a cost accumulation model used to determine the cost of the acquisition. Common stock issued as consideration in an acquisition of assets is generally measured based on the acquisition date fair value of the equity interests issued. Direct transaction costs are recognized as part of the cost of an acquisition of assets. Intangible assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as in-process research and development, or IPR&D. Acquired IPR&D that has no alternative future use is expensed immediately in the consolidated statements of operations and comprehensive loss.
Tax Incentive Receivable
The Company is eligible to receive a cash refund from the Australian Taxation Office for eligible research and development (“R&D”) expenditures under the Australian Research and Development Tax Incentive Program (the “Australian Tax Incentive”). The Australian Tax Incentive is recognized as a reduction to R&D expense when the relevant expenditure has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company’s Australian subsidiaries began operations in the second quarter of 2024, and the Company has recognized reductions to R&D expenses of $2,031,000 and $1,543,000 for the year ended December 31, 2025 and 2024, respectively. In February 2026, the Company received $2,558,000 in Australian Tax Incentive refunds.
Impairment of Definite Lived Intangible Assets
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If the carrying amount of the asset exceeds its estimated undiscounted net cash flows, before interest, the Company will recognize an impairment loss equal to the difference between its carrying amount and its estimated fair value. If impairment is recognized, the reduced carrying amount of the asset will be accounted for as its new cost. Generally, fair values are estimated using discounted cash flow, replacement cost or market comparison analyses. The process of evaluating impairment requires estimates as to future events and conditions, which are subject to varying market and economic factors. Therefore, it is reasonably possible that a change in an estimate resulting from judgements as to future events could occur which would affect the recorded amounts of the asset. No impairment losses were recorded for the years ended December 31, 2025 or 2024.
Intangible Assets
Intangible assets consist entirely of patents. Costs related to patents, which include legal and application fees, are capitalized and amortized over the estimated useful lives using the straight-line method. Patent amortization commences once final approval of the patent has been obtained. For patents purchased in an asset acquisition, the useful life is determined largely by valuation estimates of remaining economic life. The Company’s patent, purchased in connection with the Purchased Assets from Viriom, Inc. (“Viriom”) (Note 3), has a useful life of 15 years.
Fair Value of Financial Instruments
The Company accounts for financial instruments under ASC 820,Fair Value Measurements (“ASC 820”). This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels as follows:
Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 — observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and
Level 3 — assets and liabilities whose significant value drivers are unobservable.
The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, tax incentive and other receivables, accounts payable, and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts.
The following fair value hierarchy table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| | Fair value measurement at reporting date using | |||||||
| December 31, 2025 · (Level 1) · · (Level 2) · · (Level 3) | ||||||||
| Assets: | | | | | | | | |
| Cash and cash equivalents - money market funds | $2,927,000 | | $ | - | | $ | - | |
| Liabilities: | | | | | | | | |
| Warrant liabilities - Series A Warrants | $ | - | | $ | - | | $100,000 | |
| | | | | | | | | |
| December 31, 2024 | | | | | | | | |
| Assets: | | | | | | | | |
| Cash and cash equivalents - money market funds | $20,508,000 | | $ | - | | $ | - | |
| Liabilities: | | | | | | | | |
| Warrant liabilities - Series A Warrants | $ | - | | $ | - | | $13,125,000 | |
| Warrant liabilities - Pre-funded Warrants | | - | | | 29,369,000 | | | - |
On December 29, 2024, the Company entered into a Securities Purchase Agreement with several investors (the “December 2024 Purchase Agreement”) for the sale of (i) up to 3,630,205 Class A Units (“Class A Units”), each Class A Unit consisting of (a)one share of common stock orone pre-funded warrant to initially purchaseone share of common stock, and (b)one Series A Warrant to purchaseone share of common stock (“Series A Warrants”) and (ii)289,044 Class B Units”, and together, with the Class A Units, the “Units”), each Class B Unit consisting ofone pre-funded warrant andone Series A Warrant. The fair value of the pre-funded warrants was the intrinsic value of the pre-funded warrants due to their nominal exercise price. The fair value of the Series A Warrants was calculated using the Black-Scholes option pricing model and is revalued to fair value at the end of each reporting period until the earlier of the exercise or expiration of the Series A Warrants. The fair value of the Series A Warrant liability was estimated using the Black-Scholes option pricing model using the following assumptions:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| | | December 31, 2025 | | | February 18, 2025(Amendment date) | | | December 31, 2024(Issuance date) |
| Expected term of warrants (years) | | 2 years | | | 0.9 years | | | 1 year |
| Risk-free interest rate | | 3.5% | | | 4.3% | | | 4.2% |
| Expected volatility | | 121.8% | | | 137.3% | | | 126.9% |
| Dividend yield | | $ - | | | $ - | | | $ - |
The warrant liabilities were initially measured at fair value at the day of issuance and on a recurring basis. The changes in fair value of warrant liabilities will be recognized as part of the consolidated statements of operations. A summary of warrant liability activity for the year ended December 31, 2025, is as follows:
| | | |
|---|---|---|
| Balance, December 31, 2024 | $42,494,000 | |
| Reclassification of warrant liability upon exercise of pre-funded warrants | | (6,694,000) |
| Reclassification of warrant liability upon amendment of Series A Warrant agreements | | (9,133,000) |
| Change in fair value of Series A Warrants | | (26,567,000) |
| Balance, December 31, 2025 | $100,000 |
On February 18, 2025, the Company and certain of the purchasers entered into amendments to the Series A Warrants, pursuant to which the Series A Warrant liability attributable to the Series A Warrants held by such purchasers was reclassified to permanent equity. The change in fair value of the warrant liability related to the Series A Warrants was measured using the fair value of the amended Series A Warrants immediately prior to February 18, 2025.
During the first quarter of 2025, certain purchasers exercised their pre-funded warrants for an aggregate of 1,382,559 shares of the Company’s common stock. On March 27, 2025, the Company and those purchasers holding all pre-funded warrants outstanding as of such date entered into amendments to the pre-funded warrants, pursuant to which the pre-funded warrant liability was reclassified to permanent equity.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company’s assets:
| | | |
|---|---|---|
| | | Estimated Useful Life |
| Lab equipment | 5-6 years | |
| Software | 3 years | |
| Computer and office equipment | 5-6 years | |
| Leasehold improvements | Shorter of the lease term or estimated useful life |
Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized.
The Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceeds their fair value, which is measured based on the projected discounted future net cash flows generated from the assets. No impairment losses have been recorded through December 31, 2025.
Warrant Accounting
The Company evaluates all of its financial instruments, including issued share purchase warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC Topic 480, Distinguishing Liabilities from Equity, ASC Topic 505, Equity, and ASC Topic 815, Derivatives and Hedging (“ASC 815”). The Series A Warrants and pre-funded warrants issued in connection with the December 2024 Offering (defined below) did not meet the scope exception under ASC 815 and, therefore were classified as liabilities as of December 31, 2024. Certain outstanding Series A Warrants and all pre-funded warrants issued in connection with the December 2024 Offering subsequently met the scope exception under ASC 815, as a result of amending the terms of such warrants and, therefore, were reclassified to permanent equity. The remaining liability classified Series A Warrants are subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in the Company’s consolidated statements of operations. The change in fair value of warrant liability during the year ended December 31, 2025 was $26,567,000. There wasno change in fair value of warrant liability during the year ended December 31, 2024.
Foreign Currency
The reporting currency of the Company and its U.S. subsidiaries is the U.S. dollar. The functional currency of the Company’s Australian subsidiary is the U.S. dollar. Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than the U.S. dollar are included in operations in the period in which the transaction occurs and reported within the other income, net in the consolidated statements of operations. The functional currency for the Company’s German subsidiary is the euro. Translation adjustments are included as a component of accumulated other comprehensive income and gains and losses resulting from exchange rate changes on such transactions are reflected within other income, net, in the Company’s statements of comprehensive loss.
Revenue Recognition
The Company derives revenue from its collaboration and licensing agreements.
The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606,Revenue from Contracts with Customers (“ASC 606”). The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
License, Collaboration and Other Revenues
The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the
Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success.
Licensing of Intellectual Property: 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 recognizes revenue from non-refundable, 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. For licenses that are bundled with other performance obligations, the Company utilizes 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 revenue from non-refundable, up-front-fees. The Company evaluates the measure of progress each reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes 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 achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in their period of adjustment.
Manufacturing supply service: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide material rights to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon shipment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements.
Effective April 17, 2025, the Company and Symbio Pharmaceuticals Limited (“Symbio”) mutually terminated the license agreement originally entered into by and between the parties in 2011. No payments, compensation, reimbursements or settlements shall be due or owed by either party in connection with the termination of the license agreement. As a result, the Company recognized the remaining $2,733,000 of deferred revenue as revenue in April 2025.
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year ended December 31, | ||||
| | | 2025 | | 2024 |
| Symbio · · · · · · | ||||
| Upfront license fee recognition | | $2,790,000 | | $226,000 |
Deferred revenue is as follows:
| | | | |
|---|---|---|---|
| · · Symbio | |||
| · · Upfront Payment | |||
| Deferred balance at December 31, 2024 | | $2,790,000 | |
| Recognition to revenue | | | (2,790,000) |
| Deferred balance at December 31, 2025 | | $— | |
Research and Development Expenses
R&D costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and costs associated with preclinical activities and regulatory operations.
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued R&D expense, as the case may be.
Income Taxes
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. The deferred tax asset primarily includes net operating loss and tax credit carry forwards, accrued expenses not currently deductible and the cumulative temporary differences related to certain research and patent costs, which have been charged to expense in the accompanying statements of operations but have been recorded as assets for income tax purposes. The portion of any deferred tax asset for which it is more likely than not that a tax benefit will not be realized must then be offset by recording a valuation allowance. A full valuation allowance has been established against all of the deferred tax assets (Note 11), as it is more likely than not that these assets will not be realized given the Company’s history of operating losses. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position. The amount for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position.
Stock-Based Compensation Expense
The Company applies the provisions of ASC Topic 718,Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and non-employees, including employee stock options, stock appreciation rights, performance stock units and restricted stock units.
Share-based payment transactions with employees are recognized as compensation expense over the requisite service period based on their estimated fair values. The Company accounts for forfeitures in the period in which they occur. ASC 718 also requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the term and expected lives, to estimate the grant date fair value of equity-based compensation and requires the recognition of the fair value of stock compensation in the statement of operations.
Clinical Trial Expense Accruals
As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2025 and 2024, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials.
Net Income (Loss) Per Share
For purposes of net income (loss) per share, the Company’s Series C Preferred shares have the same characteristics as common stock and have no liquidation or other material preferential rights over common stock and accordingly, have been considered as a second class of common stock in the computation of income (loss) per share regardless of their legal form. Income (losses) are allocated between the common shares and the Series C Preferred on a pro rata basis, as they share equally in (losses) income and residual net assets on an as-converted basis.
Basic income (loss) per share of common stock is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during each period, including pre-funded warrants. The pre-funded warrants to purchase common stock with an exercise price of $0.01 per share are included in the calculation of basic and diluted net income (loss) per share as the exercise price is non-substantive and is virtually assured.
Diluted income (loss) per share of common stock includes the effect from the potential exercise or conversion of securities, such as stock options, unvested restricted stock units, and common stock warrants, which would result in the issuance of incremental shares of common stock, using the treasury stock method, and the potential shares of converted common stock associated with the Series C Preferred using the if-converted method. Potential common shares are excluded from the diluted per share calculation when their effect is anti-dilutive, including in periods of net loss or when inclusion does not result in a decrease in earnings per share.
For the years ended December 31, 2025 and 2024, the components of basic and diluted net income (loss) per share were as follows:
| | | | | | |
|---|---|---|---|---|---|
| | Year Ended December 31, | ||||
| (in thousands except per share amounts) · 2025 · · 2024 | |||||
| Numerator: | | | | | |
| Net income (loss) | $9,170,000 | | $(166,523,000) | ||
| | | | | | |
| Net income (loss) attributable to common stockholders | $6,865,000 | | $(54,674,000) | ||
| Net income (loss) attributable to Series C Preferred stockholders | $2,305,000 | | $(111,849,000) | ||
| | | | | | |
| Denominator: | | | | | |
| Weighted-average shares of common stock outstanding, basic | | 8,228,169 | | | 1,552,685 |
| Restricted stock units | | 6,794 | | | - |
| Stock options | | 141,417 | | | - |
| Weighted-average shares of common stock outstanding, diluted | | 8,376,380 | | | 1,552,685 |
| | | | | | |
| Net income (loss) per share of common stock, basic | $0.83 | | $(35.21) | ||
| Net income (loss) per share of common stock, diluted | $0.82 | | $(35.21) | ||
| | | | | | |
| Weighted-average shares of Series C Preferred outstanding, basic and diluted | | 6,906 | | | 7,941 |
| Net income (loss) per share of Series C Preferred, basic and diluted | $333.77 | | $(14,085.00) | ||
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:
| | | | | |
|---|---|---|---|---|
| · · December 31, | ||||
| | | 2025 | | 2024 |
| Warrants | 3,919,249 | 3,919,249 | ||
| Stock Options | 324,525 | 423,107 | ||
| Unvested restricted stock units | 15,912 | 22,421 | ||
| Series C Preferred (assumed conversion to common stock) | | 2,694,757 | | — |
| | 4,259,686 | 4,364,777 | ||
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09,* Income Taxes* (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which expands the disclosure required for income taxes. This ASU is effective for fiscal years beginning after December 16, 2024, with early adoption permitted. The Company adoptedASU 2023-09 on a prospective basis effective January 1, 2025. Accordingly, the enhanced income tax disclosures are presented in the income taxes footnote (Note 11) beginning in fiscal year 2025, and prior period disclosures have not been recast.
Recently Issued but not yet Adopted Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03,Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):Disaggregation of Income Statement Expenses, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the consolidated statement of operations. The guidance in this ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.
3. Asset Acquisition
Viriom
On September 9, 2025, the Company and Viriom, a related party (Note 12), entered into an Asset Purchase Agreement (the “Purchase Agreement”), pursuant to which the Company purchased a patent from Viriom in exchange for $2,350,000 in cash. The patent includes certain intellectual property and other assets related to a pyrrolidine antiviral compound.
The Company concluded that the acquisition of the Purchased Assets was not a business combination as the purchased assets did not meet the definition of a business under ASC 805,Business Combinations. Therefore, the Company accounted for the Purchase Agreement under the authoritative guidance for asset acquisitions, and allocated the costs of the acquisition of $2,350,000 and legal costs incurred in consummating the Purchase Agreement of $235,000 to the acquired patent. The patent has a useful life of 15 years and will be amortized on a straight-line basis over this period, as the economic benefits are expected to be realized evenly over the patent’s useful life.
Trawsfynydd
On April 1, 2024, the Company acquired Trawsfynydd, in accordance with the terms of an Agreement and Plan of Merger, dated April 1, 2024 (the “Merger Agreement”), pursuant to which the Company acquired Trawsfynydd’s tivoxavir marboxil and TRX01 programs and assumed certain liabilities associated with the acquired assets (the “Merger”). The upfront consideration included (i) the issuance of 141,982 shares of common stock of the Company at an aggregate fair value of $3,550,000, (ii) the issuance of 10,359 shares of Series C Convertible Preferred Stock (“Series C Preferred”) at an aggregate fair value of $93,232,000, and (iii) the assumption of all Trawsfynydd stock options (the “assumed options”) immediately outstanding prior to the transaction at an aggregated fair value of $7,085,000.
Each share of Series C Preferred converts into 400 shares of common stock, subject to the Beneficial Ownership Limitation (defined below). The fair value of the shares issued to Trawsfynydd and options assumed was based on the closing stock price of the Company’s common stock on April 1, 2024 of $1.00, less a discount 10.0% related to unregistered share restrictions of the preferred shares.
The Company accounted for the transaction as an asset acquisition as the Company acquired inputs and no substantive processes or outputs. The assets acquired in the transaction were measured based on the estimated fair value of the consideration paid of $112,543,000, which included direct transactions costs of $8,676,000. Tungsten Partners LLC (“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As partial compensation for services rendered by Tungsten, the Company issued to Tungsten and its affiliates and designees an aggregate of 6,747 shares of common stock and 535 shares of Series C Preferred.
The consideration paid and the relative fair values of the assets acquired and liabilities assumed were as follows:
| | | | |
|---|---|---|---|
| Consideration transferred: | | | |
| Common stock | | $3,550,000 | |
| Series C Preferred | | | 93,232,000 |
| Assumed options | | | 7,085,000 |
| Company transaction costs settled in equity | | | 4,984,000 |
| Company transaction costs paid in cash | | | 3,692,000 |
| Total consideration transferred | | $112,543,000 | |
| | | | |
| Assets acquired: | | | |
| Cash and cash equivalents | | $44,000 | |
| Total assets acquired | | $44,000 | |
| | | | |
| Liabilities assumed: | | | |
| Accrued expenses and other current liabilities | | $4,965,000 | |
| Total liabilities assumed | | | 4,965,000 |
| Net assets acquired | | | (4,921,000) |
| In-process research and development | | | 117,464,000 |
| Net assets acquired | | $112,543,000 |
The Company elected to follow the asset acquisition approach and the Trawsfynydd IPR&D assets acquired have no alternative future use to the Company. As a result, the Company charged $117,464,000 to expense within its consolidated statement of operations for the year ended December 31, 2024.
The Company’s board of directors (“Board”) approved the Merger Agreement and the related transactions, and the consummation of the Merger was not subject to approval of Company stockholders. In accordance with the Merger Agreement, three directors were appointed to the Board, and there were several changes to management, each effective as of the Closing.
Concurrently with the Closing of the Merger, the Company entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of common stock as of the applicable record date (April 15, 2024), including those holders receiving shares of common stock in connection with the Merger, is entitled toone contractual contingent value right (each, a “CVR”) entitling the holder to certain distributions of net proceeds and net sales of Traws Pharma’s two leading cancer candidates, subject to, and in accordance with, the terms and conditions of the CVR Agreement, for each share of common stock held by such holder as of the applicable record time.
The distributions in respect of the CVRs will be made on a quarterly basis, and will be subject to a number of deductions, subject to certain exceptions or limitations, including but not limited to for certain taxes and certain out-of-pocket expenses incurred by Traws Pharma. At the time of Merger and again at December 31, 2025, the value ascribed to the CVR liability was de minimis given the uncertainty related to the success of the underlying oncology programs.
4. Balance Sheet Detail
Prepaid expenses and other current assets:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| | | 2025 | | 2024 |
| Research and development | | $42,000 | | $1,514,000 |
| Insurance | | 234,000 | | 156,000 |
| Other | | 89,000 | | 178,000 |
| | | $365,000 | | $1,848,000 |
Property and Equipment:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| | | 2025 | | 2024 |
| Computer and office equipment | | $84,000 | | $84,000 |
| Less accumulated depreciation | | (77,000) | | (74,000) |
| | | $7,000 | | $10,000 |
Depreciation and amortization expense was $3,000 and $12,000 for the years ended December 31, 2025 and 2024, respectively.
Accrued expenses and other current liabilities:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Research and development | | $4,271,000 | | $2,331,000 | ||
| Employee compensation | | 936,000 | | 265,000 | ||
| Professional fees | | | 158,000 | | | 525,000 |
| Other | | | 128,000 | | | — |
| | | $5,493,000 | | $3,121,000 | ||
5. Intangible Assets
The following table summarized intangible assets included on the balance sheet:
| · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · December 31, | |||||||
| · · 2025 | |||||||
| | | Gross | | | Accumulated Amortization | | Net |
| Patent | | $2,585,000 | | | $(58,000) | | $2,527,000 |
Total amortization expense for the patent was $58,000 for the year ended December 31, 2025. There wasno amortization expense for the year ended December 31, 2024. The Company’s patent has a remaining useful life of 14.8 years.
Future amortization of intangible assets are estimated to be as follows:
| | | | |
|---|---|---|---|
| Years Ending December 31: | | | |
| 2026 | | $172,000 | |
| 2027 | | | 172,000 |
| 2028 | | | 172,000 |
| 2029 | | | 172,000 |
| 2030 | | | 172,000 |
| Thereafter | | | 1,667,000 |
| | | $2,527,000 |
6. Commitments and Contingencies
Litigation
In the normal course of business, the Company from time to time is named as a party to legal claims and actions. The Company records a loss contingency reserve for a legal proceeding when the potential loss is considered probable and can be reasonably estimated. The Company has not recorded any amounts for loss contingencies as of December 31, 2025.
On June 17, 2024, Steven M. Fruchtman informed the Board of his intent to resign from his positions of President and Chief Scientific Officer, Oncology and indicated to the Company that Dr. Fruchtman believes his resignation to be for "good reason" under the terms of his employment agreement and his expectation of compensation commensurate therewith and in connection with a change in control. The Board accepted Dr. Fruchtman’s resignation effective immediately but disagrees with the characterization of the events set forth in the letter. The Company believes that no severance payments are due to Dr. Fruchtman under the terms of his employment agreement as it pertains to termination for good reason events. The claims have been submitted to arbitration for resolution, and arbitration proceedings with the American Arbitration Association are currently scheduled to commence on June 1, 2026. At December 31, 2025, the Company determined a range of possible losses associated with Dr. Fruchtman’s claim to bezero to $1,500,000. While the Company intends to defend itself against these claims, and believes it has strong arguments to prevail in the litigation, there can be no assurance that the Company will prevail on its claims.
Contingent Value Rights
The Company issued CVRs to common stockholders as of April 15, 2024 and may be obligated to make future distributions to such CVR holders in connection with entering into strategic arrangements related to its oncology programs and/or future royalty payments related to the successful commercialization of such programs. Refer to discussion of Contingent Value Rights within Note 3.
7. Convertible Preferred Stock and Stockholders’ (Deficit) Equity
In connection with the acquisition of Trawsfynydd and the concurrent private placement of securities in April 2024 (Note 3), the Company issued shares of Series C Preferred to various individuals. Except in limited circumstances, Series C Preferred shares have no voting rights. At December 31, 2025, there were 6,737 shares of Series C Preferred outstanding. Certain material provisions of the Series C Preferred are as follows:
Conversion: Each share of Series C Preferred is convertible into 400 shares of Company common stock, subject to the Beneficial Ownership Limitation.
Dividends: Shares of series C Preferred participate in any dividends with common stockholders on an as-converted basis.
Liquidation: In the event of the liquidation, dissolution, or winding up of the affairs of the Company, whether voluntary or involuntary, the holders of Series C Preferred shall rank on parity with common stockholders as to the distribution of assets.
Beneficial Ownership Limitation: A holder of Series C Preferred is prohibited from converting shares of Series C Preferred into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 19.9% of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”)
At the Market Offering Agreement
On March 10, 2025, the Company entered into an At the Market Offering Agreement (the “ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common stock, having an aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement), from time to time, to or through Citizens, acting as sales agent and/or principal. During the year ended December 31, 2025, the Company sold and issued an aggregate of 2,517,270 shares of its common stock under the ATM Agreement for net proceeds of $5,202,000.
Amendment of Series A Warrants and Pre-funded Warrants
On February 18, 2025, the Company and certain of the purchasers of Units in the equity offering that closed on December 31, 2024 (the “December 2024 Offering”) entered into amendments to the Series A Warrants (the “Series A Warrant Amendment”), pursuant to which the Series A Warrants issued to such purchasers were amended to (i) increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the expected volatility rate to be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be utilized for calculating consideration payable to the holders of the Series A Warrants in connection with a Fundamental Transaction that is not within the Company’s control, and (iii) remove Section 3(h) of the Series A Warrants, which, under certain circumstances, provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse stock split, stock consolidation, or a recapitalization or similar event involving the Company’s common stock based on the volume weighted average price of the Company’s common stock over theeleven trading day period commencing five trading days immediately preceding such event and thefive trading days immediately following such event. The Series A Warrant Amendment resulted in the reclassification of $4,196,000 in warrant liability into permanent equity during the year ended December 31, 2025.
During the first quarter of 2025, certain purchasers of Units in the December 2024 Offering exercised their pre-funded warrants for an aggregate of 1,382,559 shares of the Company’s common stock. On March 27, 2025, the Company and those purchasers holding all pre-funded warrants outstanding as of such date entered into amendments to the pre-funded warrants (the “PFW Amendment”), pursuant to which the pre-funded warrants issued to such purchasers were amended to increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the pre-funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company. The PFW Amendment and exercises of pre-funded warrants resulted in the reclassification of $11,631,000 in warrant liability into permanent equity during the year ended December 31, 2025.
8. Warrants
The Series A Warrants and pre-funded warrants issued in connection with the December 2024 Offering did not meet the scope exception under ASC 815 and, therefore, were classified as liabilities as of December 31, 2024. However, as a result of the Series A Amendment and PFW Amendment,3,375,457 outstanding Series A Warrants and 1,928,493 outstanding pre-funded warrants met the scope exception under ASC 815 and, therefore, were reclassified to permanent equity during the year ended December 31, 2025.
Warrants outstanding and warrant activity (reflects the number of common shares as if the warrants were converted to common stock) for the year ended December 31, 2025 is as follows:
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | Balance | | | | Balance |
| · · · · Exercise · · Expiration · · December 31, · · Warrants · · December 31, | |||||||||||||
| Description · · Classification · · Price · · Date · · 2024 · · Exercised · · 2025 | |||||||||||||
| Non-tradable pre-funded warrants | | Equity | | $56.25 | | none | | 141 | | — | | 141 | |
| Non-tradable pre-funded warrants | | Equity | | $56.25 | | none | | 199 | | — | | 199 | |
| Non-tradable pre-funded warrants | | Equity | | $0.01 | | none | | 3,311,052 | | (2,628,962) | | 682,090 | |
| Series A Warrants | | Liability | | $13.42 | | Variable | | 543,792 | | — | | 543,792 | |
| Series A Warrants | | Equity | | $13.42 | | Variable | | 3,375,457 | | — | | 3,375,457 | |
| | | | | | | | | | 7,230,641 | | (2,628,962) | | 4,601,679 |
9. Stock-Based Compensation
In 2021, the Company adopted its 2021 Incentive Compensation Plan, which was subsequently amended and restated in each of 2022 and 2024 (as amended and restated, the “2021 Plan”). Upon adopting the 2021 Plan, no further awards have been or will be made under the Company’s 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”). Under the 2021 Plan, the Company may grant incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards to employees, non-employee directors, consultants, and advisors. On November 21, 2025, the Company’s stockholders approved an amendment and restatement of the Company’s Amended and Restated 2021 Incentive Compensation Plan (as so amended and restated, the “Amended Plan”), to increase the number of shares of common stock reserved and authorized for issuance thereunder by 1,500,000 shares and extend the term of the Amended Plan until November 20, 2035. At December 31, 2025, there were 827,840 shares available for future issuance with respect to new awards and outstanding awards.
Stock-based compensation expense includes stock options granted to employees and non-employees and has been reported in the Company’s consolidated statements of operations and comprehensive loss in either R&D expenses or general and administrative expenses depending on the function performed by the optionee. No net tax benefits related to the stock-based compensation costs have been recognized since the Company’s inception. The Company recognized stock-based compensation expense related to stock options and restricted stock units (“RSUs”) as follows for the year ended December 31, 2025, and 2024:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Research and development | | $124,000 | | $181,000 | ||
| General and administrative | | | 604,000 | | | 1,209,000 |
| Total stock-based compensation expense | | $728,000 | | $1,390,000 | ||
A summary of stock option activity for the twelve months ended December 31, 2025 is as follows:
| · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Options Outstanding | ||||||||
| · · · · · · · Weighted · · · | ||||||||
| | | | | Weighted- | | Average | | |
| | | | | Average | | Remaining | | Aggregate |
| | | Number | | Exercise | | Contractual | | Intrinsic |
| | | of Shares | | Price | | Term (in years) | | Value |
| Balance, December 31, 2024 | 423,107 | | $11.89 | 8.75 | | $2,698,000 | ||
| Granted | 924,650 | | $2.57 | | | | | |
| Forfeitures and expirations | (24,391) | | $113.45 | | | | | |
| Balance, December 31, 2025 | 1,323,366 | | $3.55 | 9.11 | | $85,000 | ||
| Exercisable at December 31, 2025 | | 456,900 | | $5.58 | | 7.71 | | $67,000 |
| Vested and expected to vest at December 31, 2025 | 1,323,366 | | $3.55 | 9.11 | | $85,000 | ||
The Company accounts for all stock-based payments made to employees, non-employees and directors using an option pricing model for estimating fair value. Accordingly, stock-based compensation expense is measured based on the estimated fair value of the awards on the date of grant. Compensation expense is recognized for the portion that is ultimately expected to vest over the period during which the recipient renders the required services to the Company using the straight-line single option method.
The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, assumptions related to the expected price volatility of the common stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s stock.
As of December 31, 2025, there was $1,592,000 of unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 0.92 years.
The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Year ended December 31, · | |||||||
| · · 2025 · · 2024 | |||||||
| Risk-free interest rate | | 3.82% | | 3.46% | |||
| Expected volatility | | 122.0% | | 117.9% | |||
| Expected term | | 5.47 | years | | 6.00 | years | |
| Expected dividend yield | | —% | | —% | |||
| Weighted average grant date fair value | | $2.21 | | $7.36 | | ||
The weighted-average valuation assumptions were determined as follows:
| ● | Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. |
| ● | Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected term of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin (SAB) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. |
| ● | Expected stock price volatility: Expected volatility is based on the historical volatility of the Company’s common stock. |
| ● | Expected annual dividend yield: The Company has never paid, and does not expect to pay, dividends in the foreseeable future. Accordingly, the Company assumed an expected dividend yield of 0.0%. |
The Company grants RSUs to employees under the 2021 Plan, which typically have a vesting term of 33% on each of the first and second anniversaries, and 34% on the third anniversary of the date of grant. In April 2024, the compensation committee of the Board approved RSU grants as inducement awards (“Inducement RSUs”) to certain of the Company’s employees who joined the Company in connection with the Merger. The inducement RSUs vest 25% on each of the first four anniversaries of the date of grant. The Inducement RSUs were granted outside of the Company’s incentive plans in accordance with Nasdaq Listing Rule 5635(c)(4). During the year ended December 31, 2025, the Company granted 140,651 RSUs with a weighted average grant date fair value of $2.70 per RSU.
A summary of RSU activity for the year ended December 31, 2025 is as follows:
| | | | | |
|---|---|---|---|---|
| | | Number of Units | | Weighted average grant date fair value |
| Outstanding and unvested December 31, 2024 | | 22,421 | | $ 25.12 |
| Granted | | 140,651 | | $ 2.70 |
| Vested | | (6,509) | | $ 25.44 |
| Outstanding and unvested December 31, 2025 | | 156,563 | | $ 4.97 |
At December 31, 2025, the unrecognized compensation cost related to unvested service-based RSUs was $628,000, which will be recognized over the remaining service period of 1.58 years.
Grants of PSUs and SARs
During 2020 and 2021, the compensation committee of the Board and the Board approved a cash bonus program of cash-settled stock appreciation right (“SAR”) awards to the Company’s employees and non-employee directors, and cash-settled performance stock unit (“PSU”) awards to the Company’s employees. These awards were granted outside of the Amended 2018 Plan and the 2021 Plan. As the Company’s stock price has decreased since these awards were issued, their impact on the results of operations and balance sheet of the Company was not material during 2025 or 2024.
10. Segment Information
The Company hasone operating segment. The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All the Company’s long-lived assets are held in the United States.
The accounting policies of its segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the balance sheet as total assets. The CODM uses cash forecast models in deciding how to invest into the segment. The CODM analyzes the Company’s net loss and monitors budget versus actual results to assess the performance of the Company.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended December 31, 2025 and 2024:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Years ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Revenue | | $2,790,000 | | $226,000 | ||
| Less: | | | | | | |
| Acquired in-process research and development | | — | | | 117,464,000 | |
| Research and development expenses: | | | | | | |
| Preclinical & clinical development | | | 9,456,000 | | | 7,441,000 |
| Personnel related | | | 1,852,000 | | | 2,787,000 |
| Other research and development (a) | | | 835,000 | | | 2,619,000 |
| Total research and development expenses | | 12,143,000 | | 12,847,000 | ||
| General and administrative expenses: | | | | | | |
| Professional & consulting fees | | | 3,474,000 | | | 5,954,000 |
| Personnel related | | | 2,457,000 | | | 3,035,000 |
| Other general and administrative (b) | | | 2,591,000 | | | 3,300,000 |
| Total general and administrative | | | 8,522,000 | | | 12,289,000 |
| Change in fair value of warrant liability | | | (26,567,000) | | | |
| Series A warrant and pre-funded warrant expense | | | — | | | 24,438,000 |
| Other income, net (c) | | (478,000) | | (289,000) | ||
| Net income (loss) | | $9,170,000 | | $(166,523,000) | ||
| | | | | | | |
(a)Other research and development expenses include stock based compensation, manufacturing, formulation, development, and consulting fees.
(b)Other general and administrative expenses include stock based compensation, public company costs, and insurance.
| (c) | Other income, net included interest income. |
11. Income Taxes
The Company accounts for income taxes under FASB ASC 740 (“ASC 740”). Deferred income tax assets and liabilities are determined based upon differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
Income taxes have been based on the following income (loss) before income tax expense:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| | | 2025 | | 2024 |
| Domestic | | $15,660,000 | | $(161,830,000) |
| Foreign | | (6,490,000) | | (4,696,000) |
| | | $9,170,000 | | $(166,526,000) |
As of December 31, 2025, the Company had federal net operating loss (“NOL”) carry forwards of $132,839,000 state NOL carry forwards of $39,718,000, foreign NOL of $1,610,000 and federal research and development tax credit carry forwards of $0, which may be available to reduce future taxable income. The federal NOL, that was generated before the 2025 tax year, and the tax credit carry forwards will begin to expire at various dates starting in 2026. The state NOL carry forwards will begin to expire at various dates starting in 2026. In accordance with Section 382 of the Internal Revenue Code of 1986, as amended, a change in equity ownership of greater than 50% within a three-year period results in an annual limitation on the Company’s ability to utilize its NOL carryforwards created during the tax periods prior to the change in ownership. The Company has determined that they have gone through an ownership change during 2024 and completed an ownership change analysis pursuant to Section 382. As a result, the utilization of a portion of the Company’s
NOL carryforwards is subject to an annual limitation under Section 382. The limitation may cause certain NOLs to expire unused before being fully utilized. Because the Company has incurred cumulative net operating losses since inception, all tax years remain open to examination by U.S. federal and state income tax authorities.
The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized. The Company recognizedno material adjustment for unrecognized income tax benefits. Through December 31, 2025, the Company hadno unrecognized tax benefits or related interest and penalties accrued.
The principal components of the Company’s deferred tax assets are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Deferred tax assets: | | | | | | |
| Net operating loss carryovers | | $29,865,000 | | $28,324,000 | ||
| Non-qualified stock options | | 2,544,000 | | 2,509,000 | ||
| Deferred revenue | | — | | 696,000 | ||
| Fixed assets | | — | | 2,000 | ||
| Accrued expenses | | 686,000 | | 459,000 | ||
| Capitalized research and development costs | | 6,671,000 | | 4,839,000 | ||
| Healthcare withholding - SARs | | | — | | | 11,000 |
| Deferred tax assets | | 39,766,000 | | 36,840,000 | ||
| | | | | | | |
| Less valuation allowance | | (39,766,000) | | (36,840,000) | ||
| Net deferred tax assets | | $— | | $— | ||
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its deferred tax assets at December 31, 2025. The Company experienced a net change in valuation allowance of $2,926,000 and $(137,452,000) for the years ended December 31, 2025 and 2024, respectively.
A reconciliation of the provision for income to the amount computed by applying the 21% statutory U.S. federal income tax rate to income before income taxes after the adoption of ASU 2023-09 as follows:
| | | | | | |
|---|---|---|---|---|---|
| · · Year Ended December 31, · | |||||
| · · 2025 · | |||||
| | | | | Percent | |
| Federal statutory income tax | $1,927,000 | | 21.00% | ||
| State and Local Income Taxes, Net of Federal Income Tax Effect (a) | | | — | | |
| Foreign Tax Effect | | | | | |
| Australia | | | | | |
| Statutory tax rate differential | (260,000) | | (2.83) | | |
| Research and development costs | | 1,626,000 | | 17.72 | |
| Other foreign jurisdictions | | (3,000) | | (0.03) | |
| Change in Valuation Allowance | | 2,162,000 | | 23.56 | |
| Nontaxable or Nondeductible Items | | | | | |
| Warrants | | (5,579,000) | | (60.81) | |
| Other | | 23,000 | | 0.26 | |
| Other Reconciling Items | | | | | |
| Stock options expired or cancelled | | 104,000 | | 1.13 | |
| Effective income tax rate | $— | | —% | ||
| (a) | The Company did not record state income tax expense or benefit for the period; therefore, no state-related reconciling item is included in the effective tax rate reconciliation. |
The Company did not pay income taxes during the year ended December 31, 2025. Income tax payments were not required during the period as a result of generating net operating losses. Accordingly, no disaggregation of income taxes paid by jurisdiction has been provided.
As previously disclosed for the years ended December 31, 2024 prior to the adoption of ASU 2023-09, the following is a reconciliation of the difference between the effective income tax rate and federal statutory rate:
| | | | |
|---|---|---|---|
| | | December 31, | |
| | | 2024 | |
| Federal income tax expense at statutory rate | | 21.0% | |
| Permanent items | | (17.9) | |
| Foreign permanent items | | (0.7) | |
| Foreign rate differential | | 0.1 | |
| State income tax, net of federal benefit | | 0.5 | |
| State expirations | | — | |
| Tax credits | | — | |
| Change in valuation allowance | | 83.6 | |
| Deferred tax adjustment | | (1.0) | |
| State tax rate changes | | — | |
| Sec 382 expirations | | (84.0) | |
| Other | | (1.6) | |
| Effective income tax rate | | —% |
On July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was signed into law in the United States. This comprehensive tax legislation contains a broad range of tax reforms, including provisions that allow for the immediate expensing of domestic research and development expenses, restore and make permanent 100% bonus depreciation for qualifying assets, and ease limitations on the deductibility of interest expense. The legislation has multiple effective dates, with certain provisions taking effect in 2025 and others being implemented through various future years. The Company has accounted for the provisions of the OBBBA in its consolidated financial statements. The changes did not impact income taxes due to its cumulative tax loss and tax effect of a full valuation allowance against those balances.
**12.**Research and Development Arrangements and Related Party Transactions
Research and development arrangements with unrelated parties
The Company has entered into various licensing and right-to-sublicense agreements with educational institutions for the exclusive use of patents and patent applications, as well as any patents that may develop from research being conducted by such educational institutions in the field of anticancer therapy, genes and proteins. Results from this research have been licensed to the Company pursuant to these agreements. Under one of these agreements with Temple University (“Temple”), the Company is required to make annual maintenance payments to Temple and royalty payments based upon a percentage of sales generated from any products covered by the licensed patents, with minimum specified royalty payments.
Research and development arrangements with related parties
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with ChemDiv, Inc. (“ChemDiv”). Pursuant to the Master Research and Development Agreement, ChemDiv provided services related to preclinical drug discovery to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. Dr. Nikolay Savchuk, COO of the Company and a director on the Board, is a stockholder of
ChemDiv and a member of its board of directors. During the years ended December 31, 2025 and 2024, the Company incurred R&D expense of $2,425,000 and $460,000 in the Company’s consolidated statements of operations related to ChemDiv’s services. As of December 31, 2025, the Company owed ChemDiv $63,000 which was included in accounts payable in the Company’s consolidated balance sheets.
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with Viriom, Inc. (“Viriom”). Pursuant to the Master Research and Development Agreement, Viriom provided services related to virology to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. Nikolay Savchuk, COO of the Company, serves as President of Viriom and as a member of its board of directors. Dr. Savchuk indirectly holds a significant number of its shares of common stock through a limited liability company of which Dr. Savchuk is the managing member and equity holder. Dr. Robert R. Redfield, M.D., our Chief Medical Officer, serves as a strategic advisor and member of Viriom’s board of directors. Additionally, Dr. C. David Pauza Ph.D., our Chief Science Officer, served as the Chief Science Officer of Viriom until April 1, 2024, after which time he resigned from any position with Viriom; and Iain Dukes, Executive Chairman of the Company, served as CEO of Viriom and as a member of its board of directors. On September 9, 2025, the Company and Viriom entered into the Purchase Agreement, pursuant to which the Company purchased certain assets from Viriom in exchange for $2,350,000 cash (Note 3). Effective December 2025, Viriom was sold to an unrelated third-party and is no longer a related party to the Company. During the period from January 1, 2025 through December 2025 and the year ended December 31, 2024, the Company incurred R&D expense of $244,000 and $128,000, respectively, in the Company’s consolidated statements of operations related to Viriom’s services. As of December 31, 2025, the Company owed Viriom $15,000, which was included in accounts payable in the Company’s consolidated balance sheets.
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with Expert Systems, Inc. (“Expert”). Pursuant to the Master Research and Development Agreement, Expert provided drug development and consulting services to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. An immediate family member of Dr. Savchuk had a significant ownership interest in Expert. Effective April 1, 2025, Dr. Savchuk’s family member divested his ownership interests in Expert Systems and Expert Systems is no longer a related party. During the period from January 1, 2025 through April 1, 2025, the Company incurred immaterial expenses to Expert Systems. As of December 31, 2025, the Company did not owe Expert Systems for services provided while being a related party. During the year ended December 31, 2024, $149,000 was expensed as R&D in the Company’s consolidated statements of operations related to Expert Systems services.
License Agreement with related party
In addition, prior to consummation of the Merger, Trawsfynydd entered into a License Agreement (the “Viriom License Agreement”) with Viriom, pursuant to which Trawsfynydd obtained an exclusive, royalty-free, sublicensable, world-wide license to certain Viriom patents, applications, and technical information (collectively, the “Viriom Licensed IP”) to make, have made, use, sell, offer for sale and import several classes of novel compounds related to the treatment and prevention of viral diseases, specifically for use of the Viriom Licensed IP in the development of treatment and methods to prevent viral disease in Canada, China, the European Union, Hong Kong, Japan, the United States and all areas covered by PCT applications for the Viriom Licensed IP. No annual license fees, royalties, or milestone payments are required. Additionally, pursuant to the Viriom License Agreement, Trawsfynydd obtained the right to control prosecution, defense of infringement and enforcement. As a result of the Merger, the rights and obligations of Trawsfynydd under the Viriom License Agreement were transferred to the Company (through its subsidiaries).
Unless terminated earlier pursuant to the agreement, the Viriom License Agreement shall remain in force and effect for the life of the last-to-expire patent included in the Viriom Licensed IP or last-to-be abandoned patent application licensed under the agreement, whichever is later. The Viriom License Agreement can be terminated by either party due to the material breach of either party (subject to a cure period).
13. License and Collaboration Agreements
SymBio Agreement
In July 2011, the Company entered into a license agreement with SymBio Pharmaceuticals Limited (“SymBio”), which has been subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and commercialization of rigosertib in Japan and Korea. Under the SymBio license agreement, SymBio is obligated to use commercially reasonable efforts to develop and obtain market approval for rigosertib inside the licensed territory and the Company has similar obligations outside of the licensed territory. The Company has also entered into an agreement with SymBio providing for it to supply SymBio with development-stage product. Under the SymBio license agreement, the Company also agreed to supply commercial product to SymBio under specified terms that will be included in a commercial supply agreement to be negotiated prior to the first commercial sale of rigosertib. The supply of development-stage product and the supply of commercial product will be at the Company’s cost plus a defined profit margin. Sales of development-stage product have been de minimis. The Company has additionally granted SymBio a right of first negotiation to license or obtain the rights to develop and commercialize compounds having a chemical structure similar to rigosertib in the licensed territory.
Under the terms of the SymBio license agreement, the Company received an upfront payment of $7,500,000 in 2011. The Company assessed the SymBio arrangement in accordance with ASC 606 and determined that its performance obligations under the SymBio agreement include the exclusive, royalty-bearing, sublicensable license to rigosertib, the research and development services to be provided by the Company and its obligation to serve on a joint committee. The Company concluded that the license was not distinct since it was of no benefit to SymBio without the ongoing research and development services and that, as such, the license and the research and development services should be bundled as a single performance obligation. Since the provision of the license and research and development services are considered a single performance obligation, the $7,500,000 upfront payment was being recognized as revenue ratably through the expected period over which the Company expected the research and development services to be performed. Effective April 17, 2025, the Company and Symbio mutually terminated the license agreement originally entered into by and between the parties in 2011. No payments, compensation, reimbursements or settlements shall be due or owed by either party in connection with the termination of the license agreement. As a result, the Company recognized the $2,733,000 of deferred revenue as revenue on April 17, 2025.
HanX Narazaciclib (ON 123300) Agreement
In December 2017, the Company entered into a license and collaboration agreement with HanX Biopharmaceuticals, Inc. (“HanX”), a company focused on development of novel oncology products, for the further development, registration and commercialization of narazaciclib in Greater China. Narazaciclib is a preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. The key feature of the collaboration was that HanX provided all funding required for the Chinese IND enabling studies necessary in order to seek IND approval by the National Medical Products Administration (“Chinese FDA”). The Chinese IND was approved in January 2020. The Company and HanX also intended for these studies underlying the Chinese IND approval, to meet the US FDA standards for IND approval. Accordingly, such studies were used by the Company for an IND filing with the US FDA in November 2020. In September 2020, a Phase 1 Study with narazaciclib in cancer patients was initiated in China. The Company maintains global rights to the study and study data outside of China. The US FDA Study May Proceed letter was issued in December 2020. Enrollment into the US phase 1 study (“Study 19-01”) commenced in May 2021.
If the compound receives regulatory approval and is commercialized, the Company would receive regulatory and commercial milestone payments, as well as royalties on sales in the Greater China territory.
Pint Agreement
On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the “Pint License Agreement”) and a Securities Purchase Agreement (the “Pint Securities Purchase Agreement”) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as “Pint”).
Under the terms of the Pint License Agreement, the Company granted Pint an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and commercialize any pharmaceutical product (the “Pint Licensed Product”) containing rigosertib in all uses of rigosertib in humans in Latin American countries (the “Pint Territory”, including Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, French Guiana, British Guiana, Suriname, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela).
Pint agreed to make an upfront equity investment in the Company’s common stock. In addition, the Company could receive additional regulatory, development and sales-based milestone payments, an additional equity investment, as well as tiered, double digit royalties based on net aggregate net sales in the Pint Territory. Pint and the Company have also agreed to enter into a supply agreement providing for Pint purchasing rigosertib and the Pint Licensed Product from the Company within 90 days of FDA approval of an NDA for the Pint Licensed Product.
Pint may terminate the Pint License Agreement in whole (but not in part) at any time upon 45 days’ prior written notice. The Pint License Agreement also contains certain provisions for termination by either party in the event of breach of the Pint License Agreement by the other party, subject to a cure period, or bankruptcy of the other party.
In addition, under the Pint Securities Purchase Agreement, if the FDA approves the NDA for the Pint Licensed Product, Pint will reimburse the Company for certain research and development expenses. Half of the reimbursement amount will be paid in cash, the other half of the amount will be by an equity investment at a premium to the average of the volume weighted average price of common stock for the ten consecutive trading days ended on the day the FDA approves the NDA.
Knight Agreement
In November 2019, the Company entered into a Distribution, License and Supply Agreement (the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”). Under the terms of the Knight License Agreement, the Company granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the “Knight Licensed Product”) containing rigosertib for Canada (and Israel should Knight exercise its option) (the “Knight Territory”) and in human uses (the “Knight Licensed Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the Knight Licensed Product in the Knight Territory and in the Knight Licensed Field.
Knight has also agreed to obtain from the Company all of Knight’s requirements of the Knight Licensed Products for the Knight Territory, and the Company has agreed to supply Knight with all of its requirements of the Knight Licensed Products. The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the Knight Licensed Products.
In addition, the Company has granted Knight an exclusive right of first refusal with respect to all or any part of the Knight Territory, to store, market, promote, sell, offer for sale and/or distribute any ROFR Products. As used in the Knight License Agreement, “ROFR Products” means all products other than the Knight Licensed Product that are owned, licensed, or controlled by the Company as of the effective date and all improvements thereto.
The Company is eligible to receive clinical, regulatory and sales-based milestone payments. The Company is also eligible to receive tiered double-digit royalties based on net sales in the Knight Territory.
The Knight License Agreement is for a term of 15 years from the launch on a country-by-country basis in the Knight Territory and contains customary provisions for termination by either party in the event of breach of the Knight License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee.
Specialised Therapeutics Asia Pte. Ltd. Agreement
On December 18, 2019, the Company entered into a Distribution, License and Supply Agreement (the “STA License Agreement”) with Specialised Therapeutics Asia Pte. Ltd. (“STA”). Under the terms of the STA License Agreement, the Company granted STA (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the “STA Licensed Product”) containing rigosertib for Australia and New Zealand (the “STA Territory”) and in human uses (the “Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the STA Licensed Product in the STA Territory and in the Field.
STA has also agreed to obtain from the Company all of STA’s requirements of the STA Licensed Products for the STA Territory, and the Company has agreed to supply STA with all of its requirements of the STA Licensed Products. The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the STA Licensed Products.
The Company may be entitled to receive clinical, regulatory and sale-based milestone payments. The Company may also be entitled to receive tiered double-digit royalties based on net sales in the Territory.
The License Agreement is for a term of 15 years from the launch on a country-by-country basis in the Territory and contains customary provisions for termination by either party in the event of breach of the License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee.
14. Subsequent Events
On April 15, 2026, the Company completed the April 2026 Financing, with funding expected April 16, 2026, for aggregate gross proceeds of up to $60.0 million. The April 2026 Financing consisted of (i) $10.0 million of upfront gross proceeds at closing from the sale of 5,982,919 shares of the Company's common stock (including pre-funded warrants in lieu thereof), (ii) the issuance of milestone-based warrants with an aggregate exercise price of $10.0 million that becomes exercisable upon receipt of approval from the Medicines and Healthcare products Regulatory Agency ("MHRA") to conduct the human challenge trial, (iii) the issuance of additional milestone-based warrants with an aggregate exercise price of $10.0 million that becomes exercisable upon shareholder approval and the announcement of data from the human challenge trial and (iv) the issuance of common warrants, subject to shareholder approval, with athree-year term to purchase shares of the Company's common stock providing potential additional gross proceeds of $30.0 million if fully exercised. The milestone-based warrants and the common warrants each have an exercise price equal to the per share purchase price in the April 2026 Financing. The common warrants are subject to a forced exercise provision if the trading price of the Company's common stock equals or exceeds 200% of the applicable exercise price for 30 consecutive trading days. The milestone-based warrants become exercisable only upon achievement of the applicable milestone conditions, and there can be no assurance that we will receive any additional proceeds from the exercise of the milestone-based warrants or the common warrants, or as to the timing thereof.
The Company incurred placement agent fees and other offering costs in connection with the April 2026 Financing, including a cash success fee equal to 6% of the upfront gross proceeds.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.