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Traws Pharma, Inc.

For the period ended Mar 31, 2025. Filed May 15, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 15, 2025

TRAW$0.24+8.2%Stored close · as of Nov 9, 2026

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Notes to Condensed 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 in two 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 has four 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 COVID19; (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.

Reverse Stock Split

In September 2024, the Company effected a one-for-25 reverse stock split of its issued and outstanding shares of common stock (the “Reverse Stock Split”). All share and per share amounts for the Company’s common stock, as well as the number of shares of common stock issuable upon conversion of outstanding preferred stock, exercise of options and warrants outstanding (and the exercise prices thereof) and settlement of outstanding restricted stock units, from dates prior to completion of the Reverse Stock Split that are included in the financial statements and the accompanying footnote for periods prior to the Reverse Split have been retroactively restated to give effect to the Reverse Stock Split.

Liquidity

The Company has incurred recurring operating losses since inception. As of March 31, 2025, the Company had an accumulated deficit of $627,664,000. The Company anticipates that operating losses will continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates and its clinical programs, strategic alliances and its administrative organization. At March 31, 2025, the Company had cash and cash equivalents of $15,937,000. 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.

Nasdaq Compliance

The Company received multiple notifications from The Nasdaq Stock Market LLC (“Nasdaq”) staff (the “Staff”) in 2024 regarding non-compliance with continued listing requirements. On February 25, 2025, the Company received a letter from Nasdaq confirming that the Company has regained compliance with Listing Rule 5550(b)(1) related to minimum stockholders’ equity requirements, as required by the Hearings Panel of Nasdaq’s decision dated December 13, 2024. Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a mandatory panel monitor for a period of one year from the date of such letter.

2. Summary of Significant Accounting Policies

Basis of Presentation

The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated 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, as of and for the three months ended March 31, 2025. 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 Warrants (as defined below) liability.

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of March 31, 2025, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, the consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three months ended March 31, 2025 and 2024 and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis

as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2025, the results of its operations for the three months ended March 31, 2025 and 2024, and its cash flows for the three months ended March 31, 2025 and 2024. The financial data and other information disclosed in these notes related to the three months ended March 31, 2025 and 2024 are unaudited. The results for the three months ended March 31, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2024 included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2024 (“Annual Report”), filed with the SEC on March 31, 2025.

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 interim 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 March 31, 2025, the Company had $14,281,000 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.

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company deposits its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation (“FDIC”). At times, the Company’s cash balances may exceed the current insured amounts provided by the FDIC. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents.

Significant Accounting Policies

These interim condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and SEC instructions for interim financial information, and should be read in conjunction with the Company's Annual Report. Significant accounting policies and other disclosures normally provided have been omitted since such items are disclosed in the Company's Annual Report. The Company uses the same accounting policies in preparing quarterly and annual financial statements.

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 $63,000 for the three months ended March 31, 2025.

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, 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
March 31, 2025 · (Level 1) · ​ · (Level 2) · ​ · (Level 3)
Assets:​​​​​​​​
Cash equivalents - money market funds$14,281,000​$-​$-
Liabilities:​​​
Warrant liabilities - Series A Warrants$-​$-​$154,000
​​​​​​​​​
December 31, 2024​​​​​​​​
Assets:​​​​​​​​
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 is 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:

​​​​​​
​​March 31, 2025​​December 31, 2024 (Issuance date)
Expected term of warrants (years)​0.8 year​​1 year
Risk-free interest rate​4.1%​​4.2%
Expected volatility​153.3%​​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 three months ended March 31, 2025 is as follows:

​​​
Balance, December 31, 2024$42,494,000
Change in fair value​(26,513,000)
Reclassification of warrant liability upon exercise of prefunded warrants and amended warrant agreements​(15,827,000)
Balance, March 31, 2025$154,000
​​​

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 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.

Revenues and Deferred Revenues

The Company’s revenue during the three months ended March 31, 2025 and 2024 was from its license and collaboration agreement with SymBio Pharmaceuticals Limited (“Symbio”).

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Three Months Ended March 31, · ​
​ · 2025 · 2024
Symbio · ​ · ​ · ​ · ​ · ​ · ​ · ​
Upfront license fee recognition over time​$57,000​$56,000​

Deferred revenue is as follows:

​​​​
​ · ​ · Symbio
​Upfront Payment
Deferred balance at December 31, 2024​$2,791,000
Recognition of revenue​​(57,000)
Deferred balance at March 31, 2025​$2,734,000

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.

Net income (loss) per share

For purposes of net income (loss) per share, the Company’s Series C Non-Voting Convertible Preferred (“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 net 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 income (losses) 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 are included in the calculation of basic and diluted net income (loss) per share as the exercise price of $0.01 per share 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 three months ended March 31, 2025 and 2024, the components of basic and diluted net income (loss) per share were as follows:

​​​​​​
​Three Months Ended March 31,
(in thousands except per share amounts) · 2025 · 2024
Numerator:​​​​​
Net income (loss)$21,490,000​$(4,983,000)
​​​​​​
Net income (loss) attributable to common stockholders$15,083,000​$(4,983,000)
Net income (loss) attributable to Series C Preferred stockholders$6,407,000​$-
​​​​​​
Denominator:​​​​​
Weighted-average shares of common stock outstanding, basic​6,965,927​​841,738
Restricted stock units​878​​-
Stock options​248,320​​-
Weighted-average shares of common stock outstanding, diluted​7,215,125​​841,738
​​​​​​
Net income (loss) per share of common stock, basic$2.17​$(5.92)
Net income (loss) per share of common stock, diluted$2.09​$(5.92)
​​​​​​
Weighted-average shares of Series C Preferred outstanding, basic and diluted​7,398​​-
Net income (loss) per share of Series C Preferred, basic and diluted$866.04​$-
​​​​​​

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:

​​​​​
​ · ​ · March 31,
​ · 2025 · 2024
Warrants3,375,45712,309
Stock Options211,14091,702
Unvested restricted stock units29,9386,585
Series C Preferred (as converted to common stock)​2,959,200​—
​6,575,735110,596

Recently Issued but not yet Adopted Accounting Pronouncements

In December 2023, the Financial Accounting Standards Board (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 amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the effect of this ASU on its disclosures.

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

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 ratutrelvir programs and assumed certain liabilities associated with the acquired assets. 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 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 is convertible 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 10.0% discount related to unregistered share restrictions of the Series C 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’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 of the Merger.

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 Company 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 the Company’s two leading oncology drug 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 the Company. At the time of Merger and again at March 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:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​​March 31,​December 31,​
​ · 2025 · 2024 · ​
Research and development​$933,000​$1,514,000​
Insurance​149,000​156,000​
Other​183,000​178,000​
​​$1,265,000​$1,848,000​

Property and equipment:

​ · ​ · ​ · ​ · ​ · ​ · ​
​​March 31,​December 31,
​ · 2025 · 2024
Computer and office equipment​$84,000​$84,000
Less accumulated depreciation​(75,000)​(74,000)
​​$9,000​$10,000

Accrued expenses and other current liabilities:

​​​​​​​​
​ · ​ · March 31, · ​ · December 31, · ​
​ · 2025 · 2024 · ​
Research and development​$1,905,000​$2,331,000​
Employee compensation​591,000​265,000​
Professional fees​​23,000​​525,000​
​​$2,519,000​$3,121,000​

5. 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 March 31, 2025.

On June 17, 2024, Steven M. Fruchtman informed the Board of his intent to resign from his positions as 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. At March 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.

6. Convertible Preferred Stock and Stockholders’ Equity (Deficit)

In connection with the acquisition of Trawfynydd and the concurrent private placement of securities (Note 3), the Company issued shares of Series C Preferred to various individuals. Series C Preferred shares have no voting rights. At March 31, 2025, there were 7,398 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: Series C Preferred participates 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 (a “Liquidation”), the holders of Series C Preferred shall rank on parity with common stockholders as to the distributions of assets.

Beneficial Ownership Limitation: A holder of Series C Preferred is prohibited from converting its 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 Company 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 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 three months ended March 31, 2025, the Company sold and issued 42,100 shares of its common stock under the ATM Agreement for net proceeds of $115,000.

Amendment of Series A Warrants and Pre-funded Warrants

On February 18, 2025, the Company and certain of the purchasers of Units in the private placement 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 three months ended March 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 three months ended March 31, 2025.

7. Warrants

Common stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815,Derivatives and Hedging - Contracts in Entity’s Own Equity (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. The conditions within ASC 815-40 are not subject to a probability assessment. The equity classified warrants do not fall under the liability criteria within ASC 480 Distinguishing Liabilities from Equity, as they are not puttable and do not represent an instrument that has a redeemable underlying security. The equity classified warrants do meet the definition of a derivative instrument under ASC 815, but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding. The Series A Warrants and pre-funded warrants issued in connection with the December 2024 Purchase Agreement did not meet the scope exception under ASC 815 and, therefore, were classified as liabilities as of December 31, 2024. As a result of the Series A Amendment and PFW Amendment,3,375,457 Series A

Warrants and 1,928,493 pre-funded warrants met the scope exception under ASC 815 and, therefore, were reclassified to permanent equity during the three months ended March 31, 2025.

Warrants outstanding and warrant activity (reflects the number of common shares as if the warrants were converted to common stock) for the three months ended March 31, 2025 is as follows:

​​​​​​​​​​​​​​
​​​​​​​​​Balance​​​Balance
​ · ​ · ​ · ​ · Exercise · ​ · Expiration · ​ · December 31, · ​ · Warrants · ​ · March 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​(1,382,559)​1,928,493
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​(1,382,559)​5,848,082

8. 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. 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. At March 31, 2025, there were 255,146 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 unaudited condensed 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 three months ended March 31, 2025 and 2024:

​​​​​​​​
​ · ​ · Three Months Ended March 31, · ​
​ · 2025 · 2024
Research and development​$16,000​$151,000​
General and administrative​​145,000​​182,000​
Total stock-based compensation expense​$161,000​$333,000​

A summary of stock option activity for the three months ended March 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, 2024423,107​$11.898.75​$2,698,000
Granted60,742​$4.46​—​—
Forfeitures(1,333)​$17.67​—​—
Expired(23,056)​$109.73​—​—
Balance, March 31, 2025459,460​$6.12​8.46​$231,000
Exercisable at March 31, 2025406,320​$6.14​8.34​$231,000

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 March 31, 2025, there was $198,000 of unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 1.1 years.

The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value of stock options include the following:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Three Months Ended March 31, · ​ · ​
​ · 2025 · 2024
Risk-free interest rate​4.42%​—%
Expected volatility​119.1%​—%
Expected term​5years​—years
Expected dividend yield​—%​—%
Weighted average grant date fair value​$3.74​$—​​

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 life 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 restricted stock units to employees under the 2021 Plan, which typically have a vesting term of 33% on the first and second anniversary, and 34% on the third anniversary of the date of grant. In April 2024, the compensation committee of the Board approved restricted stock unit 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 three months ended March 31, 2025, the Company granted 9,603 restricted stock units with a weighted average grant date fair value of $7.81 per unit.

A summary of RSU activity for the three months ended March 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​9,603​7.81
Vested​(1,208)​27.34
Outstanding and unvested March 31, 2025​30,816​19.64

At March 31, 2025, the unrecognized compensation cost related to unvested service-based RSUs was $467,000 which will be recognized over the remaining service period of 2.8 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 awards to the Company’s employees and non-employee directors, and cash-settled performance stock unit awards to the Company’s employees. These awards were granted outside of the Company’s 2018 Omnibus Incentive Compensation 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 are not material during 2025 or 2024.

9. Segment Information

The Company hasone operating segment. The Company’s chief operating decision maker (“CODM”) is the interim chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All of 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 unaudited condensed 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 income (loss) and monitors budget versus actual results to assess the performance of the Company.

The table below summarizes the significant expense categories, included within the unaudited condensed consolidated statements of operations, regularly reviewed by the CODM for the three months ended March 31, 2025 and 2024:

​​​​​​​
​ · ​ · Three Months Ended March 31,
​ · 2025 · 2024
Revenue​$57,000​$56,000
Less:​​​​​​
Research and development expenses:​​​​​​
Preclinical & clinical development​​627,000​​709,000
Personnel related​​465,000​​673,000
Other research and development (a)​​1,414,000​​530,000
Total research and development expenses​2,506,000​1,912,000
General and administrative expenses:​​​​​​
Professional & consulting fees​​—​​—
Personnel related​​904,000​​772,000
Other general and administrative (b)​​1,850,000​​2,584,000
Total general and administrative​​2,754,000​​3,356,000
Change in fair value of warrant liability​​(26,513,000)​​—
Other income, net​(180,000)​(229,000)
Net income (loss)​$21,490,000​$(4,983,000)
​​​​​​​
(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.

10. 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. Asno sales had been generated through March 31, 2025 under the licensed patents, the Company has not incurred any royalty expenses related to this agreement. In addition, the Company is required to pay Temple a percentage of any sublicensing fees received by the Company.

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 three months ended March 31, 2025, $1,006,000 was expensed as R&D in the Company’s unaudited condensed consolidated statements of operations related to ChemDiv’s services. As

of March 31, 2025 and December 31, 2024, the Company owed ChemDiv $2,298,000 and $10,000, respectively, 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 has investment control of Viriom and 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. During the three months ended March 31, 2025, $246,000 was expensed as R&D in the Company’s unaudited condensed consolidated statements of operations related to Viriom’s services. As of March 31, 2025, the Company included $15,000 in accounts payable related to Viriom in the unaudited condensed consolidated balance sheets. As of December 31, 2024, the Company included $113,000 and $15,000 in accounts payable and accrued expenses, respectively, related to Viriom in the 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 has significant ownership in Expert. During the three months ended March 31, 2025, $72,000 was expensed as general and administrative expense in the Company’s unaudited consolidated statements of operations related to Expert’s services. As of March 31, 2025, $77,000 was included in accounts payable in the Company’s unaudited condensed consolidated balance sheets. As of December 31, 2024, $77,000 and $72,000 was included in accounts payable and accrued expenses, respectively, in the Company’s consolidated balance sheets.

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).

11. Subsequent Events

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 will recognize the $2.7 million of deferred revenue as revenue in April 2025.

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