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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2026

Or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: 001-36020

Traws Pharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware

  ​ ​ ​

22-3627252

(State or other jurisdiction of

(I.R.S. Employer

incorporation or organization)

Identification No.)

12 Penns Trail, Newtown, PA

18940

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (267) 759-3680

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

  ​ ​ ​

Trading Symbol(s)

  ​ ​ ​

Name of each exchange on which registered

Common Stock, par value $.01 per share

TRAW

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes   No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).   Yes   No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).   Yes   No

The number of outstanding shares of the registrant’s Common Stock, par value $0.01 per share, as of May 12, 2026 was 15,150,669.

Table of Contents

TRAWS PHARMA, INC.

TABLE OF CONTENTS FOR QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2026

Page

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

3

Condensed Consolidated Balance Sheets

3

Condensed Consolidated Statements of Operations

4

Condensed Consolidated Statements of Comprehensive (Loss) Income

5

Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit

6

Condensed Consolidated Statements of Cash Flows

7

Notes to Condensed Consolidated Financial Statements

8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

21

Item 3. Quantitative and Qualitative Disclosures About Market Risk

32

Item 4. Controls and Procedures

32

PART II — OTHER INFORMATION

Item 1. Legal Proceedings

32

Item 1A. Risk Factors

33

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

34

Item 3. Defaults Upon Senior Securities

34

Item 4. Mine Safety Disclosures

34

Item 5. Other Information

34

Item 6. Exhibits

35

SIGNATURES

36

2

Table of Contents

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

Traws Pharma, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

March 31, 

December 31, 

2026

2025

Assets

Current assets:

Cash and cash equivalents

$

3,133,000

$

3,820,000

Tax incentive and other receivables

 

1,687,000

 

3,794,000

Prepaid expenses and other assets

 

845,000

 

365,000

Total current assets

 

5,665,000

 

7,979,000

Property and equipment, net

 

6,000

 

7,000

Intangible assets, net

2,484,000

2,527,000

Other assets

 

1,000

 

104,000

Total assets

$

8,156,000

$

10,617,000

Liabilities and stockholders’ deficit

Current liabilities:

Accounts payable

$

7,665,000

$

5,653,000

Accrued expenses and other liabilities

 

5,543,000

 

5,493,000

Total current liabilities

 

13,208,000

 

11,146,000

Warrant liabilities

 

259,000

 

100,000

Total liabilities

 

13,467,000

11,246,000

Commitments and contingencies (Note 5)

Stockholders’ deficit:

Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares issued and 6,737 shares outstanding at March 31, 2026 and December 31, 2025

 

 

Common stock, $0.01 par value, 250,000,000 shares authorized, 10,162,587 and 9,067,774 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

 

101,000

 

90,000

Additional paid-in capital

 

641,681,000

 

639,259,000

Accumulated deficit

 

(647,091,000)

 

(639,984,000)

Accumulated other comprehensive (loss) income

 

(2,000)

 

6,000

Total stockholders’ deficit

 

(5,311,000)

 

(629,000)

Total liabilities and stockholders’ deficit

$

8,156,000

$

10,617,000

See accompanying notes to condensed consolidated financial statements.

3

Table of Contents

Traws Pharma, Inc.

Condensed Consolidated Statements of Operations (unaudited)

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Revenue

$

$

57,000

Operating expenses:

Research and development

 

4,912,000

 

2,506,000

General and administrative

 

2,034,000

 

2,754,000

Total operating expenses

 

6,946,000

 

5,260,000

Loss from operations

 

(6,946,000)

 

(5,203,000)

Change in fair value of warrant liability

 

(159,000)

 

26,513,000

Other income, net

 

(2,000)

 

180,000

Net (loss) income

$

(7,107,000)

$

21,490,000

Net (loss) income attributable to common stockholders, basic and diluted

$

(5,692,000)

$

15,083,000

Weighted-average shares of common stock outstanding, basic

10,640,625

6,965,927

Net (loss) income per share of common stock, basic

$

(0.53)

$

2.17

Weighted-average shares of common stock outstanding, diluted

10,640,625

7,215,125

Net (loss) income per share of common stock, diluted

$

(0.53)

$

2.09

Net (loss) income attributable to Series C Preferred stockholders, basic and diluted

$

(1,415,000)

$

6,407,000

Weighted-average shares of Series C Preferred outstanding, basic and diluted

6,737

7,398

Net (loss) income per share of Series C Preferred, basic and diluted

$

(210.03)

$

866.04

See accompanying notes to condensed consolidated financial statements.

4

Table of Contents

Traws Pharma, Inc.

Condensed Consolidated Statements of Comprehensive (Loss) Income

(unaudited)

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Net (loss) income

$

(7,107,000)

$

21,490,000

Other comprehensive (loss) income

Foreign currency translation adjustments

 

(8,000)

 

23,000

Other comprehensive (loss) income

(8,000)

23,000

Comprehensive (loss) income

$

(7,115,000)

$

21,513,000

See accompanying notes to condensed consolidated financial statements.

5

Table of Contents

Traws Pharma, Inc.

Consolidated Statement of Convertible Preferred Stock and Stockholders’ Deficit (unaudited)

Accumulated

Additional

other

Preferred Stock

Common Stock

Paid-in

Accumulated

comprehensive

  ​ ​ ​

Shares

  ​ ​

Amount

  ​

Shares

  ​ ​

Amount

  ​ ​

Capital

  ​ ​

deficit

  ​ ​

income (loss)

  ​ ​

Total

Balance at December 31, 2025

6,737

$

9,067,774

$

90,000

$

639,259,000

$

(639,984,000)

$

6,000

$

(629,000)

Stock-based compensation

 

 

634,000

 

 

 

634,000

Shares issued for vested restricted stock units

4,813

 

 

Issuance of common stock, net of offering costs

1,090,000

 

11,000

 

1,788,000

 

 

 

1,799,000

Other comprehensive loss

 

 

 

 

 

(8,000)

 

(8,000)

Net loss

 

 

 

 

(7,107,000)

 

 

(7,107,000)

Balance at March 31, 2026

6,737

$

10,162,587

$

101,000

$

641,681,000

$

(647,091,000)

$

(2,000)

$

(5,311,000)

Balance at December 31, 2024

7,398

$

3,650,731

$

36,000

$

617,530,000

$

(649,154,000)

$

(42,000)

$

(31,630,000)

Stock-based compensation

 

 

 

 

161,000

 

 

 

161,000

Shares issued for vested restricted stock units

 

1,208

 

 

 

 

 

Issuance of common stock, net of offering costs

42,100

115,000

115,000

Reclassification of warrant liability upon exercise of prefunded warrants and amended warrant agreements

15,827,000

15,827,000

Exercise of prefunded warrants

1,382,559

14,000

14,000

Other comprehensive income

 

 

 

 

 

 

23,000

 

23,000

Net income

 

 

 

 

 

21,490,000

 

 

21,490,000

Balance at March 31, 2025

7,398

$

5,076,598

$

50,000

$

633,633,000

$

(627,664,000)

$

(19,000)

$

6,000,000

See accompanying notes to condensed consolidated financial statements.

6

Table of Contents

Traws Pharma, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

  ​ ​ ​

Operating activities:

Net (loss) income

$

(7,107,000)

$

21,490,000

Adjustment to reconcile net loss to net cash used in operating activities:

Change in fair value of warrant liability

159,000

(26,513,000)

Depreciation and amortization

 

44,000

 

1,000

Stock-based compensation

 

634,000

 

161,000

Changes in assets and liabilities:

Receivables

 

2,107,000

 

111,000

Prepaid expenses and other current assets

 

(480,000)

 

774,000

Other assets

5,000

(197,000)

Accounts payable

 

2,012,000

 

(605,000)

Accrued expenses and other current liabilities

 

50,000

 

(602,000)

Deferred revenue

 

 

(57,000)

Net cash used in operating activities

 

(2,576,000)

 

(5,437,000)

Financing activities:

Proceeds from sale of common stock pursuant to the ATM

1,897,000

122,000

Payment of offering costs

(123,000)

Proceeds from exercised prefunded warrants

14,000

Net cash provided by financing activities

 

1,897,000

 

13,000

Effect of foreign currency translation on cash

 

(8,000)

 

23,000

Net (decrease) increase in cash and cash equivalents

 

(687,000)

 

(5,401,000)

Cash and cash equivalents at beginning of period

 

3,820,000

 

21,338,000

Cash and cash equivalents at end of period

$

3,133,000

$

15,937,000

Supplemental disclosure of cash flow information:

Reclassification of warrant liability upon exercise of prefunded warrants and amended warrant agreements

$

$

15,827,000

Deferred offering costs in accounts payable

$

$

75,000

See accompanying notes to condensed consolidated financial statements.

7

Table of Contents

TRAWS PHARMA, INC.

Notes to Condensed and 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 SARS-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.  

Liquidity

The Company has incurred recurring operating losses since inception. As of March 31, 2026, the Company had an accumulated deficit of $647,091,000. 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, 2026, the Company had cash and cash equivalents of $3,133,000. 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 biopharmaceutical 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.

8

Table of Contents

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. 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, 2026, the condensed consolidated statements of operations and comprehensive (loss) income for the three months ended March 31, 2026 and 2025, the consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three months ended March 31, 2026 and 2025 and the condensed consolidated statements of cash flows for the three months ended March 31, 2026 and 2025 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, 2026, the results of its operations for the three months ended March 31, 2026 and 2025, and its cash flows for the three months ended March 31, 2026 and 2025. The financial data and other information disclosed in these notes related to the three months ended March 31, 2026 and 2025 are unaudited. The results for the three months ended March 31, 2026 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, 2025 included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2025 (“Annual Report”), filed with the SEC on April 15, 2026.

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 has one 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.

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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 has no financial instruments with off-balance sheet risk of loss.

At March 31, 2026, the Company had $1,342,000 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.

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 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 $400,000 and $63,000 for the three months ended March 31, 2026 and 2025, respectively.

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 three months ended March 31, 2026 or 2025.

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”), 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:

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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, 2026

(Level 1)

(Level 2)

(Level 3)

Assets:

Cash and cash equivalents - money market funds

$

1,342,000

$

-

$

-

Liabilities:

  ​ ​ ​

  ​ ​ ​

  ​ ​ ​

  ​ ​ ​

  ​ ​ ​

Warrant liabilities - Series A Warrants

$

-

$

-

$

259,000

December 31, 2025

Assets:

Cash and cash equivalents - money market funds

$

2,927,000

$

-

$

-

Liabilities:

  ​ ​ ​

  ​ ​ ​

  ​ ​ ​

  ​ ​ ​

  ​ ​ ​

Warrant liabilities - Series A Warrants

$

-

$

-

$

100,000

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 or one pre-funded warrant to initially purchase one share of common stock and (b) one Series A Warrant to purchase one share of common stock (“Series A Warrants”), and (ii) 289,044 Class B Units (the “Class B Units,” and, together with the Class A Units, the “Units”), each Class B Unit consisting of one pre-funded warrant and one 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, 2026

December 31, 2025

Expected term of warrants (years)

1.75 years

2 years

Risk-free interest rate

3.8%

3.5%

Expected volatility

121.8%

121.8%

Dividend yield

$ -

$ -

The warrant liabilities were initially measured at fair value at the date 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, 2026, is as follows:

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Balance, December 31, 2025

$

100,000

Change in fair value of Series A Warrants

159,000

Balance, March 31, 2026

$

259,000

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 (loss) income per share

For purposes of net (loss) income 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 net (loss) income per share regardless of their legal form. (Losses) income 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 (loss) income per share of common stock is computed by dividing net (loss) income 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 (loss) income per share as the exercise price is non-substantive and is virtually assured.

Diluted (loss) income 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.

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For the three months ended March 31, 2026, and 2025, the components of basic and diluted net (loss) income per share were as follows:

Three Months Ended March 31, 

(in thousands except per share amounts)

2026

  ​ ​ ​

2025

Numerator:

Net (loss) income

$

(7,107,000)

$

21,490,000

Net (loss) income attributable to common stockholders

$

(5,692,000)

$

15,083,000

Net (loss) income attributable to Series C Preferred stockholders

$

(1,415,000)

$

6,407,000

Denominator:

Weighted-average shares of common stock outstanding, basic

10,640,625

6,965,927

Restricted stock units

-

878

Stock options

-

248,320

Weighted-average shares of common stock outstanding, diluted

10,640,625

7,215,125

Net (loss) income per share of common stock, basic

$

(0.53)

$

2.17

Net (loss) income per share of common stock, diluted

$

(0.53)

$

2.09

Weighted-average shares of Series C Preferred outstanding, basic and diluted

6,737

7,398

Net (loss) income per share of Series C Preferred, basic and diluted

$

(210.03)

$

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, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Warrants

 

3,919,249

 

3,919,249

Stock Options

 

2,037,913

 

211,140

Unvested restricted stock units

 

151,750

 

29,938

Series C Preferred (assumed conversion to common stock)

2,694,757

2,959,200

 

8,803,669

 

7,119,527

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.

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3. Balance Sheet Detail

Prepaid expenses and other current assets:

March 31, 

December 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Research and development

$

572,000

$

42,000

Insurance

 

135,000

 

234,000

Other

 

138,000

 

89,000

$

845,000

$

365,000

Accrued expenses and other current liabilities:

March 31, 

December 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Research and development

$

3,996,000

$

4,271,000

Employee compensation

 

1,275,000

 

936,000

Professional fees

272,000

158,000

Other

128,000

$

5,543,000

$

5,493,000

4. Intangible Assets

The following table summarizes intangible assets included on the balance sheet:

March 31, 

2026

Gross

Accumulated Amortization

Net

Patent

$

2,585,000

$

(101,000)

$

2,484,000

Total amortization expense for the patent was $43,000 for the three months ended March 31, 2026. There was no amortization expense for the three months ended March 31, 2025.

Future amortization of intangible assets are estimated to be as follows:

Years Ending December 31:

2026 (remaining 9 months)

$

129,000

2027

172,000

2028

172,000

2029

172,000

2030

172,000

Thereafter

1,667,000

$

2,484,000

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5. Commitments and Contingencies

Litigation

In the normal course of business, the Company is from time to time 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, 2026.

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, and arbitration proceedings with the American Arbitration Association are currently scheduled to commence on June 1, 2026. At March 31, 2026, the Company determined a range of possible losses associated with Dr. Fruchtman’s claim to be zero 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.

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

At March 31, 2026, 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 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”).

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Table of Contents

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 three months ended March 31, 2026, the Company sold and issued an aggregate of 1,090,000 shares of its common stock under the ATM Agreement for net proceeds of $1,799,000.

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 the eleven trading day period commencing five trading days immediately preceding such event and the five 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. No warrants had been granted during the three months ended March 31, 2026.

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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, 2026 is as follows:

Balance

Balance

Exercise

Expiration

December 31, 

March 31, 

Description

  ​ ​ ​

Classification

  ​ ​ ​

Price

  ​ ​ ​

Date

  ​ ​ ​

2025

  ​ ​ ​

2026

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

682,090

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

4,601,679

4,601,679

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 (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. At March 31, 2026, there were 113,298 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, 2026, and 2025:

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

  ​ ​ ​

Research and development

$

466,000

$

16,000

General and administrative

168,000

145,000

Total stock-based compensation expense

$

634,000

$

161,000

A summary of stock option activity for the three months ended March 31, 2026 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, 2025

 

1,323,366

$

3.55

 

9.11

$

85,000

Granted

 

724,170

$

1.60

 

Forfeitures and expirations

 

(9,623)

$

88.81

 

Balance, March 31, 2026

 

2,037,913

$

2.43

9.29

$

266,000

Exercisable at March 31, 2026

506,020

$

3.26

7.34

$

67,000

Vested and expected to vest at March 31, 2026

 

2,037,913

$

2.43

 

9.29

$

266,000

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.

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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 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, 2026, there was $2,076,000 of  unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 0.8 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, 

  ​ ​ ​

2026

  ​ ​ ​

2025

 

  ​ ​ ​

Risk-free interest rate

 

3.76

%  

4.42

%  

 

Expected volatility

 

122.3

%  

119.1

%  

 

Expected term

 

5.5

years  

5.00

years

 

Expected dividend yield

 

%  

%  

 

Weighted average grant date fair value

$

1.38

$

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 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. The compensation committee of the Board has approved RSU grants as inducement awards which 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).

A summary of RSU activity for the three months ended March 31, 2026 is as follows:

Number of Units

Weighted average grant date fair value

Outstanding and unvested December 31, 2025

156,563

$ 4.97

Granted

-

$ -

Vested

(4,813)

$ 7.84

Outstanding and unvested March 31, 2026

151,750

$ 4.88

At March 31, 2026, the unrecognized compensation cost related to unvested service-based RSUs was $511,000, which will be recognized over the remaining service period of 1.4 years.

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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 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 2026 or 2025.

9. Segment Information

The Company has one operating segment. The Company’s 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 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 (loss) income 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, 2026, and 2025:

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Revenue

$

$

57,000

Less:

Research and development expenses:

Preclinical & clinical development

2,613,000

627,000

Personnel related

389,000

465,000

Other research and development (a)

1,910,000

1,414,000

Total research and development expenses

 

4,912,000

 

2,506,000

General and administrative expenses:

Professional & consulting fees

785,000

Personnel related

666,000

904,000

Other general and administrative (b)

583,000

1,850,000

Total general and administrative

2,034,000

2,754,000

Change in fair value of warrant liability

159,000

(26,513,000)

Other income, net (c)

 

2,000

 

(180,000)

Net (loss) income

$

(7,107,000)

$

21,490,000

(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.

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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.

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, 2026 and 2025, the Company expensed $1,373,000 and $1,006,000, respectively, as research and development (“R&D”) costs related to ChemDiv’s services in the condensed consolidated statement of operations. As of March 31, 2026, the Company owed ChemDiv $1,856,000, which was included in accounts payable in the Company’s consolidated balance sheets.

11. Subsequent Events

In April 2026, the Company completed the April 2026 Financing, 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 a three-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.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with interim unaudited condensed consolidated financial statements contained in Part I, Item 1 of this quarterly report on Form 10-Q (“Quarterly Report”), and the audited consolidated financial statements and notes thereto for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our annual report on Form 10-K for the year ended December 31, 2025, filed with the SEC on April 15, 2026 (“Annual Report”). As used in this Quarterly Report, unless the context suggests otherwise, the “Company,” “we,” “us,” “our,” “Traws” or “Traws Pharma” refers to Traws Pharma, Inc. and its consolidated subsidiaries.

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report includes forward-looking statements. We may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements appear in a number of places throughout this Quarterly Report and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the implementation of our business model and strategic plans for our business, our ongoing and planned preclinical development and clinical trials, our interactions with the U.S. Food and Drug Administration (“FDA”) and similar foreign authorities, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, protection of our intellectual property portfolio, the degree of clinical utility of our products, particularly in specific patient populations, our ability to develop commercial and manufacturing functions, expectations regarding clinical trial data, potential accelerated pathways to FDA approval that may be available for our product candidates, our results of operations, cash needs, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report.

Actual results could differ materially from our forward-looking statements due to a number of factors, including without limitation risks related to:

our need for additional financing for our future clinical trials and other operations, our ability to obtain sufficient funds on acceptable terms when needed, and our plans and future needs to scale back operations if adequate financing is not obtained;
our ability to continue as a going concern;
our ability to establish additional partnerships for the further development of, or to otherwise monetize, any of our legacy assets;
any future payouts under the contingent value right (“CVR”) issued to our holders of record as of the close of business on April 15, 2024;
our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
the success and timing of our preclinical studies and clinical trials, including without limitation site

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initiation and patient enrollment, and regulatory approval of protocols for future clinical trials;
our ability to enter into, maintain and perform collaboration agreements with other biotechnology or pharmaceutical companies, for funding and commercialization of our clinical drug product candidates or preclinical compounds, and our ability to achieve certain milestones under those agreements;
the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling under any approval we may obtain;
our plans and ability to develop, manufacture and commercialize our product candidates;
our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
the size and growth of the potential markets for our product candidates and our ability to serve those markets;
regulatory developments in the United States and foreign countries;
the rate and degree of market acceptance of any of our product candidates;
obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;
the successful development of our commercialization capabilities, including sales and marketing capabilities;
recently implemented, and the potential for additional, cuts in federal funding and related budget cuts;
recently enacted and future legislation and regulation regarding the healthcare system;
the success of competing therapies and products that are or may become available;
our ability to maintain the listing of our securities on a national securities exchange;
the potential for third party disputes and litigation;
the performance of third parties, including contract research organizations (“CROs”) and third-party manufacturers; and
the effects of market volatility, macroeconomic factors, uncertainty with respect to the federal budget and debt ceiling, including potential government shutdowns related thereto, and geopolitical instability on our business, our partners and our suppliers.

Any forward-looking statements that we make in this Quarterly Report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

You should also read carefully the factors described in the “Risk Factors” in this Quarterly Report and our most recent Annual Report, to better understand significant risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, actual results could differ materially and adversely from those

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anticipated or implied in the forward-looking statements in this Quarterly Report and you should not place undue reliance on any forward-looking statements.

Overview

As of March 31, 2026, we had cash and cash equivalents of $3.1 million and an accumulated deficit of $647.1 million. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met. Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this Quarterly Report to support our operations for at least the 12 months following the date that the condensed consolidated financial statements included herein are issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that such financial statements are issued.

We are exploring various sources of funding for development and applying for regulatory approval of our research compounds as well as for our ongoing operations. If we raise additional funds through strategic collaborations and alliances or licensing arrangements with third parties, which may include existing collaboration partners, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms that are not favorable to us. There can be no assurance, however, that we will be successful in obtaining such financing in sufficient amounts, on terms acceptable to us, or at all. In addition, there can be no assurance that we will obtain approvals necessary to market our product candidates or achieve profitability or sustainable, positive cash flow. If we are unable to successfully raise sufficient additional capital, through future financings or through strategic and collaborative arrangements, we will not have sufficient cash to fund our ongoing trials and operations.

Our Portfolio/ Product Candidates/ Compounds

We are a clinical-stage biopharmaceutical company aiming to address unmet medical needs in respiratory viral diseases and cancer. We have four clinical programs:

Tivoxavir marboxil, which we acquired as part of our 2024 merger with Trawsfynydd Therapeutics, Inc. (the “Merger”), is a small molecule cap-dependent endonuclease inhibitor. Cap-dependent endonuclease (“CEN”) is an enzyme that is important for influenza virus replication. Tivoxavir marboxil is intended to inhibit CEN and, thus, is intended to impede influenza virus replication including, the influenza A or B viral strains and bird flu viral strains. It is our intention to develop tivoxavir marboxil as an oral dose given only once for potential treatment and prophylaxis of bird flu and seasonal influenza.

The first-in-man clinical study of tivoxavir marboxil (designated AV5124 in a previous study) was performed from May to September of 2023 in Russia. The study sponsor was Pharmasyntez, JSC. We have the right to use the data resulting from the study outside of Russia and the Eurasian Economic Community countries. The trial was a single ascending dose study, and, as such, each study participant only received one dose of tivoxavir marboxil. The study consisted of four dose cohorts that received 20, 40, 80 or 120 mg tivoxavir marboxil delivered as 20 mg strength tablets, or placebo. The study enrolled 28 healthy males ages 18-45 years who received either the study drug or placebo. The primary study endpoint was measurement of the safety and tolerability of single drug doses in healthy volunteers. The secondary endpoint was the measurement of pharmacokinetic parameters of single drug doses in healthy volunteers on an empty stomach or after a meal. In the study, one subject who received a single 40 mg dose of the study drug, experienced two adverse events (“AEs”). This subject experienced hyperglycemia, which was deemed to be mild and believed probably related to tivoxavir marboxil, and erosive gastritis with complications in the form of severe iron deficiency anemia, which was considered to be a serious adverse event (“SAE”) believed unlikely to be related (doubtful per the protocol) to the study drug.

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There were no other AEs in the trial, including at higher doses. The pharmacokinetic measurements indicated a small food effect for tivoxavir marboxil, with increased exposure when the drug was taken after a meal but otherwise showed increasing exposure with increasing dose.

We advanced the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee (“HREC”). This study enrolled four cohorts of 8 participants each, with 6 participants randomized to receive study drug and 2 participants assigned to receive placebo in each cohort. Participants were required to be healthy males or females ages 18-64 years. Participants took either one dose of the study drug or one dose of placebo. Dose levels evaluated in this study included 80, 120, 240 and 480 mg in capsules, taken orally. The primary endpoint of the study was the determination of safety and tolerability; the secondary and other endpoints included the determination of the drug pharmacokinetic profile. Topline data showed good overall tolerability and a pharmacokinetic profile that appears to support the potential use of tivoxavir marboxil as a one-time treatment for influenza. Sixteen AEs were recorded, of which three were reported as possibly related to study drug during the study; all were mild headaches. Topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 and within the predicted therapeutic window for more than 23 days. On March 21, 2025, we submitted a request for a meeting with the FDA to align on a path forward, including to seek guidance regarding the potential for accelerated approval utilizing the “Animal Rule” for further development of tivoxavir marboxil in the treatment of H5N1 bird flu. The FDA “Animal Rule” allows approval of therapeutic interventions in cases where there is a risk of severe disease and a controlled human trial would be unethical or infeasible. Our meeting request was granted, and we submitted our briefing package to the FDA on April 24, 2025. On May 27, 2025, we received written responses from the FDA for a Type B pre-Investigational New Drug Application meeting (“pre-IND”). The FDA provided feedback on development paths for potential approval of tivoxavir marboxil for bird flu and seasonal flu, including on the potential use of the Animal Rule. On June 30, 2025, we announced our submission of briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu, as a follow up to the pre-IND FDA interactions.

In addition, on June 30, 2025, we announced our proposed Phase 2 dose-ranging, non-inferiority study, which will evaluate the effects of tivoxavir marboxil in patients with seasonal influenza. A separate single arm will evaluate the effects of tivoxavir marboxil in patients infected with H5N1 bird flu. The proposed study has been submitted for HREC review and, once initiated, is expected to enroll subjects in Australia and selected countries in Southeast Asia with high rates of human bird flu infections. During a Type D meeting, the FDA affirmed its position that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. We have determined to defer the initiation of this study at this time due to the low immediate likelihood of successfully recruiting a Phase 2 study incorporating bird flu-infected subjects. However, we believe that recent approval of our Phase 2 bird flu/seasonal flu phase 2 protocol by Australian and South Korean regulatory authorities will allow us to quickly initiate a clinical study in either the Southern or Northern Hemispheres, respectively, should the incidence rate of bird flu increase. In January 2026, we announced plans to progress an additional indication for TXM as a monthly oral tablet for prophylaxis of seasonal influenza, supported by Phase 1 exposure observations from an earlier capsule formulation and formulation work indicating that a compressed tablet may provide extended coverage; we also announced that a time slot was secured for a human influenza prophylaxis human challenge trial targeted for June 2026, contingent on completion of a planned bridging healthy volunteer study. Separately, FDA informed the Company that its US IND for tivoxavir marboxil was being placed on clinical hold due to concerns with the toxicology data package. The Company is actively engaging with the FDA to address the clinical hold and is working to develop and submit a comprehensive response, with the goal of resolving the hold and advancing the program in the US by the end of 2026.

Ratutrelvir (“TRX01”), which we acquired as part of the Merger, is an inhibitor of the main protease (also known as 3CL protease) of the SARS-CoV-2 virus, the causative agent in COVID-19. The main

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protease is an essential component in the mechanism for SARS-CoV-2 replication. TRX01 is intended to inhibit this protease and reduce SARS-CoV-2 virus replication. In vitro laboratory tests that measured the impact of TRX01 on SARS-CoV-2 replication, demonstrated that TRX01 inhibited the replication of viral isolates of the original SARS-CoV-2 isolates, and viral variants in the delta and omicron types. An animal study using the widely adopted K18 transgenic mouse model, demonstrated non-inferiority between TRX01 and the combination of nirmatrelvir + ritonavir, in terms of time to death and lung virus burden in this highly lethal model with neurological manifestations. Based on preclinical pharmacokinetic studies in multiple animal species, we intend to develop TRX01 for use without co-administration of a human cytochrome P450 (“CYP”) inhibitor such as ritonavir.

TRX01 was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases. Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia. It was sponsored by the Company and was approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo). Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group. The single ascending dose portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses. Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo) for 10 consecutive days. The study was completed in September 2024. There were few recorded adverse events reported up to the highest dose, and none were determined to be related to study drug. Topline data from the study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days.

TRX01 was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases. Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia. It was sponsored by the Company and was approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo). Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group. The single ascending dose portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses. Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo in each cohort) for 10 consecutive days. The study was completed in September 2024. There were few recorded AEs reported up to the highest dose, and none were determined to be related to study drug. Topline data from the study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days. On June 30, 2025, we announced our proposed Phase 2 non-inferiority study, which will evaluate the effects of ratutrelvir in newly diagnosed COVID-19 patients, and on August 18, 2025, we announced receipt of approval from the HREC to proceed with the Phase 2 study. The study is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID®. In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID-19. On October 14, 2025, we announced the dosing of the first subject in our Phase 2 study to evaluate ratutrelvir. We intend to initiate a separate single arm to evaluate the safety and efficacy of ratutrelvir in newly diagnosed COVID-19 patients who are ineligible for treatment with PAXLOVID®. On December 17, 2025, we reported positive interim Phase 2 data showing ratutrelvir had a favorable tolerability profile versus PAXLOVID® and no viral rebound events were observed in ratutrelvir-treated patients, while a rebound occurred in the

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PAXLOVID®  arm. Interim results also showed activity in PAXLOVID® -eligible patients. On January 13, 2026, we reported interim data in a larger sample of 50 patients, suggesting faster time to sustained symptom resolution for ratutrelvir versus PAXLOVID®, continued no rebounds with ratutrelvir, and consistent safety/benefit signals in PAXLOVID®-eligible patients. On January 26, 2026, we announced the completion of enrollment of our ongoing 90-patient, open-label Phase 2 study of ratutrelvir versus PAXLOVID® in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID®-ineligible subjects.    

Narazaciclib is our oral CDK4-plus inhibitor intended initially to treat breast, endometrial and other cancers. Narazaciclib is a multi-targeted kinase inhibitor targeting multiple CDK’s, AMP-activated protein kinase (“AMPK”), related protein kinase 5 (“ARK5”), and colony-stimulating factor 1 receptor (“CSF1R”) at low nM concentrations, as well as other tyrosine kinases believed to drive tumor cell proliferation, survival and metastasis. We initiated a multi-center Phase 1/2a trial evaluating narazaciclib in combination with letrozole as a second or third-line therapy for recurrent metastatic low-grade endometrioid endometrial cancer in the first calendar quarter of 2023. In this study, both narazaciclib and letrozole were administered orally in the Phase 1 dose escalation phase. The first patient in this trial was dosed in May 2023 and the initial cohort (160 mg) was completed and no DLTs were observed. The 200 mg cohort enrolled 6 evaluable subjects, but two patients experienced dose limiting toxicities. As a result, the dose of narazaciclib of 160mg once daily in combination with letrozole 2.5mg QD was declared to be the maximum tolerated dose and the recommended Phase 2 dose for women with low grade endometrioid endometrial cancer. This study is now closed to accrual. The database has been locked, and a clinical study report is final.

Another Phase 1 study of narazaciclib as a monotherapy has also been conducted in patients with relapsed and/or refractory advanced cancer. The objectives of this study were to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of narazaciclib administered orally as escalating daily doses in patients with advanced cancer relapsed or refractory to at least 1 prior line of therapy. Narazaciclib was dosed on a continuous daily schedule in 28-day cycles. In this study, the highest dose tested was 280mg once daily given continuously. This study is now closed to accrual.

We do not intend to initiate further Company-sponsored development for narazaciclib and expect our activities to be limited primarily to (i) completing analysis and reporting from completed studies, (ii) maintaining intellectual property and other program-enabling documentation, and (iii) supporting business development efforts.

Rigosertib is our second asset in oncology. Rigosertib is currently being studied in investigator initiated trials for epidermolysis bullosa-associated squamous cell carcinoma. Both studies included the use of either IV or oral rigosertib, depending on the clinical need of the patient. This is due to GI obstruction arising as a result of the presence of esophageal strictures complicating oral administration or extreme skin fragility complicating IV administration. It is, therefore, important in these patients that the investigator has both dosing options for the appropriate dosing of their patients. The data presented here are preliminary and may be subject to change. Our objective for this program is to establish partnerships for the development of rigosertib in this indication.

Recent Developments

April 2026 Financing

In April 2026, we completed a financing transaction, for aggregate gross proceeds of up to $60.0 million (the "April 2026 Financing"). 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 our 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 in the UK, (iii) the issuance of additional milestone-based warrant with an aggregate exercise price of $10.0 million that

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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 a three-year term to purchase shares of our 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 our 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.

At close, we paid transaction costs including a cash success fee equal to 6% of the upfront gross proceeds, and we intend to use the net proceeds for working capital and general corporate purposes, including funding our clinical and regulatory activities.

Results of Operations

Comparison of the Three Months Ended March 31, 2026 and 2025

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

  ​ ​ ​

Change

Revenue

$

$

57,000

$

(57,000)

Operating expenses:

 

  ​

 

  ​

 

  ​

Research and development

 

4,912,000

 

2,506,000

 

(2,406,000)

General and administrative

 

2,034,000

 

2,754,000

 

720,000

Total operating expenses

 

6,946,000

 

5,260,000

 

(1,686,000)

 

Loss from operations

 

(6,946,000)

 

(5,203,000)

 

(1,743,000)

 

Change in fair value of warrant liability

(159,000)

26,513,000

(26,672,000)

Other income, net

 

(2,000)

 

180,000

 

(182,000)

 

Net (loss) income

$

(7,107,000)

$

21,490,000

$

(28,597,000)

Research and development expenses

The details of our research and development expenses are:

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

  ​ ​ ​

Virology

4,000,000

1,774,000

Oncology

57,000

251,000

Personnel related

 

389,000

 

465,000

Stock based compensation

 

466,000

 

16,000

$

4,912,000

$

2,506,000

Research and development expenses increased by $2.4 million, or 96%, to $4.9 million for the three months ended March 31, 2026 from $2.5 million for the three months ended March 31, 2025. This increase was primarily related to a $2.2 million increase in virology expenses due to our ongoing development activities for ratutrelvir, tivoxavir marboxil, and TRX01, including the completion of our Phase 2a clinical trial for ratutrelvir and the initiation of a bridging study for tivoxavir marboxil in March 2026 and a $0.5 million increase in stock based compensation expenses, partially offset by a $0.2 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets and a $0.1 million decrease in personnel expenses.

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General and administrative expenses

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Professional & consulting fees

$

785,000

$

1,192,000

Stock based compensation

168,000

145,000

Personnel related

 

666,000

 

904,000

Public company costs

 

225,000

 

320,000

Insurance & other

190,000

193,000

$

2,034,000

$

2,754,000

General and administrative expenses decreased by $0.8 million, or (26)%, to $2.0 million for the three months ended March 31, 2026 from $2.8 million for the three months ended March 31, 2025.

Change in fair value of warrant liability

Change in fair value of warrant liability during the three months ended March 31, 2026 was $0.2 million. Change in fair value of warrant liability of $26.5 million during the three months ended March 31, 2025 represents the remeasurement of the warrant liability upon amendment of the pre-funded and Series A Warrants, whereas the previously liability-classified warrants were reclassified to permanent equity, the exercise of pre-funded warrants, and the remaining Series A Warrants as of March 31, 2025.

Liquidity and Capital Resources

As of March 31, 2026, we had cash and cash equivalents of $3.1 million, an accumulated deficit of $647.1 million, and a working capital deficit of $7.9 million. Since inception, we have experienced negative cash flows from our operations and expect to continue to incur significant expenses in connection with our ongoing activities.  

In April 2026, we completed the April 2026 Financing. The April 2026 Financing consisted of (i) $10.0 million of upfront gross proceeds at closing from the sale of shares of our common stock (or pre-funded warrants in lieu thereof), (ii) a milestone-based warrant 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 in the UK, (iii) a second milestone-based warrant 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) common warrants, subject to shareholder approval, with a three-year term to purchase shares of our common stock, providing potential additional gross proceeds of $30.0 million if fully exercised.

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. If we do not receive additional proceeds from the exercise of the warrants or obtain capital from other sources, we will need to raise additional capital to fund our operations and to satisfy our obligations as they become due.

Based on our current projections, as of the date of this Quarterly Report, we believe that our existing cash and cash equivalents, together with the net proceeds received at closing from the April 2026 Financing, will not be sufficient to fund our operating requirements for at least the 12 months following the date that the consolidated financial statements included herein are issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that such financial statements are issued.

We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue to execute our strategy. There can be no assurance that we will be successful in obtaining such funding in sufficient

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amounts, on terms acceptable to us, or at all. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition.

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 we be unable to continue as a going concern.

Cash Flows

The following table summarizes the Company’s cash flows for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31, 

  ​ ​ ​

2026

  ​ ​ ​

2025

Net cash (used in) provided by:

 

  ​

 

  ​

Operating activities

$

(2,576,000)

$

(5,437,000)

Financing activities

 

1,897,000

 

13,000

Effect of foreign currency translation

 

(8,000)

 

23,000

Net decrease in cash and cash equivalents

$

(687,000)

$

(5,401,000)

Operating Activities

Net cash used in operating activities was $2.6 million for the three months ended March 31, 2026, which consisted of net loss of $7.1 million, non-cash charges, partially offset by $0.8 million primarily attributable to stock-based compensation, and a $4.1 million change in operating assets and liabilities. Significant changes in operating assets and liabilities included an increase in accounts payable due to timing of invoices and payments to our vendors, which was partially offset by net decreases in prepaid expenses and other assets.

Net cash used in operating activities was $5.4 million for the three months ended March 31, 2025, which consisted of non-cash charges of $26.4 million primarily attributable to the change in fair value of warrant liability of $26.5 million and stock-based compensation of $0.2 million, partially offset by net income of $21.5 million and a $0.6 million change in operating assets and liabilities. Significant changes in operating assets and liabilities included a net decrease in accounts payable and accrued expenses of $1.2 million due to timing of invoices and payments to our vendors, which was partially offset by net decreases in prepaid expenses and other assets and receivables of $0.7 million.

Financing Activities

Net cash provided by financing activities was $1.9 million for the three months ended March 31, 2026, and was attributable to the proceeds received from the sale of shares of our common stock under our ongoing At The Market equity offering, offered pursuant to that certain At The Market Offering Agreement, dated March 10, 2025, by and between the Company and Citizens JMP Securities, LLC (“Citizens”) (the “ATM Agreement”), 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, including the “baby shelf” limitation under General Instruction I.B.6. of Form S-3), from time to time, to or through Citizens, acting as sales agent and/or principal.

Material Cash Requirements

We have not achieved profitability since our inception and we expect to continue to incur net losses for the foreseeable future. We expect net cash expended in 2026 to be higher than 2025 due to clinical trials and increased headcount in our clinical and regulatory groups. We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that, currently, our non-cancelable obligations under these agreements are not material. Based on current projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than one year following the

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date that these financial statements from our Quarterly Report on Form 10-Q are issued. These conditions raise substantial doubt about our ability to continue as a going concern through the one-year period after the date that the financial statements are issued.

We are exploring various sources of funding for continued development and any potential in-licensed compounds as well as our ongoing operations. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development and clinical trials of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met. If we obtain regulatory approval for any of our product candidates, we expect to incur significant NDA preparation and commercialization expenses. We do not currently have a relationship with an organization for the sales, marketing and distribution of pharmaceutical products. In the future, we may rely on licensing and co-promotion agreements with strategic or collaborative partners for the commercialization of our products in the United States and other territories. If we choose to build a commercial infrastructure to support marketing in the United States for any of our product candidates that achieve regulatory approval, such commercial infrastructure could be expected to include a targeted, oncology sales force supported by sales management, internal sales support, an internal marketing group and distribution support. To develop the appropriate commercial infrastructure internally, we would have to invest financial and management resources, some of which would have to be deployed prior to having any certainty about marketing approval. Furthermore, we have and expect to continue to incur additional costs associated with operating as a public company.

For additional risks, please see “Risk Factors” in Part II of this Quarterly Report and previously disclosed in our Annual Report.

Pro Forma Impact of the April 2026 Financing

The following financial information has been developed by application of pro forma adjustments to the historical financial statements of the Company appearing elsewhere in this Quarterly Report. The unaudited pro forma information gives effect to the 2026 private placement.

 

The unaudited pro forma financial information is presented for informational purposes only and does not purport to represent what the results of operations or financial position of the Company would have been had the transactions described above actually occurred on the dates indicated, nor do they purport to project the financial condition of the Company for any future period or as of any future date. The unaudited pro forma financial information should be read in conjunction with the Company’s financial statements and notes thereto included elsewhere in this Quarterly Report.

 

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Unaudited Pro Forma Balance Sheet

As of March 31, 2026

As Reported

Adjustments

Pro Forma As Adjusted

April 2026 Financing

Assets

Current assets:

Cash and cash equivalents

$

3,133,000

$

9,400,000

$

12,533,000

Tax incentive and other receivables

 

1,687,000

 

 

1,687,000

Prepaid expenses and other assets

 

845,000

 

 

845,000

Total current assets

 

5,665,000

 

9,400,000

 

15,065,000

Property and equipment, net

 

6,000

 

 

6,000

Intangible assets, net

2,484,000

2,484,000

Other assets

 

1,000

 

 

1,000

Total assets

$

8,156,000

$

9,400,000

$

17,556,000

Liabilities and stockholders’ (deficit) equity

Current liabilities:

Accounts payable

$

7,665,000

$

$

7,665,000

Accrued expenses and other liabilities

 

5,543,000

 

 

5,543,000

Total current liabilities

 

13,208,000

 

 

13,208,000

Warrant liabilities

 

259,000

 

 

259,000

Total liabilities

 

13,467,000

 

 

13,467,000

Stockholders’ (deficit) equity:

Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares issued and 6,737 shares outstanding at March 31, 2026 and December 31, 2025

 

 

 

Common stock, $0.01 par value, 250,000,000 shares authorized, 10,162,587 and 16,145,506 shares issued and outstanding at March 31, 2026 as reported and pro forma, respectively

 

101,000

 

 

101,000

Additional paid-in capital

 

641,681,000

 

9,400,000

 

651,081,000

Accumulated deficit

 

(647,091,000)

 

 

(647,091,000)

Accumulated other comprehensive income

 

(2,000)

 

 

(2,000)

Total stockholders’ (deficit) equity

 

(5,311,000)

 

9,400,000

 

4,089,000

Total liabilities and stockholders’ (deficit) equity

$

8,156,000

$

9,400,000

$

17,556,000

The unaudited pro forma balance sheet as of March 31, 2026 gives effect to an assumed $10.0 million gross equity financing completed after March 31, 2026. Offering costs are assumed to be $0.6 million (6% of gross proceeds) and are reflected as a reduction of additional paid-in capital in accordance with U.S. GAAP. No proceeds from warrant exercises are reflected.

Critical Accounting Policies and Estimates

This Management’s Discussion and Analysis of our Financial Condition and Results of Operations is based on our interim unaudited condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, stock-based compensation, and the contingent value rights. We base our estimates on historical experience,

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known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. As of March 31, 2026, there have been no significant changes in our critical accounting policies and estimates as discussed in our Annual Report.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

As a smaller reporting company, the Company is not required to provide the information otherwise required by this Item.

Item 4. Controls and Procedures

Management’s Evaluation of our Disclosure Controls and Procedures

Our management, with the participation of our principal executive and principal financial officers, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our principal executive and principal financial officers concluded that, as of such date, our disclosure controls and procedures were effective.  

Inherent Limitations on Effectiveness of Controls

Our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well-designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of the effectiveness of controls to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

Item 1. Legal Proceedings

For a description of our material pending legal proceedings, please see Note 5, Commitments and Contingencies, to our unaudited condensed consolidated financial statements included in Part I of this Quarterly Report. We may, in the

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ordinary course of business, face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation. If this were to happen, the payment of any such awards could have a material adverse effect on our business, financial condition and results of operations. Additionally, any such claims, whether or not successful, could damage our reputation and business.

Item 1A. Risk Factors

In addition to the other information set forth in this Quarterly Report, you should carefully consider the risk factors discussed in Part I, “Item 1A.  Risk Factors” in our Annual Report and in other reports filed with the SEC, which could materially affect our business, financial condition or future results. The risks described in our Annual Report are not the only risks we face.  Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

There have not been any material changes to the risk factors disclosed in the Annual Report.

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Recent Sales of Unregistered Securities

During the three months ended March 31, 2026, there were no unregistered sales of our securities that were not reported in a Current Report on Form 8-K.

Repurchases

The Company did not repurchase any of the Company’s outstanding equity securities during the three months ended March 31, 2026.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

During the three months ended March 31, 2026, none of our directors or officers informed us of any adoption, modification, or termination of any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (a “Rule 10b5-1 trading arrangement”) or any “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K).

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Item 6. Exhibits

EXHIBIT INDEX

Exhibit
Number

  ​ ​ ​

Description

31.1

 *

Rule 13a-14(a)/15d-14(a) Certifications of Principal Executive Officer

31.2

 *

Rule 13a-14(a)/15d-14(a) Certifications of Principal Financial Officer

32.1

 **

Section 1350 Certifications of Principal Executive Officer

32.2

 **

Section 1350 Certifications of Principal Financial Officer

101.INS

Inline XBRL Instance Document – The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

101.SCH

† 

Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents

104

Cover Page Interactive Data File -The cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

*   Filed herewith

** Furnished herewith

† The XBRL related information in Exhibit 101 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability of that section and shall not be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

TRAWS PHARMA, INC.

 

 

Dated: May 15, 2026

 

 

 

 

/s/ Iain Dukes, D. Phil

 

Iain Dukes, D. Phil

 

Chief Executive Officer

 

(Duly Authorized Officer and Principal Executive Officer)

 

 

Dated: May 15, 2026

 

 

 

 

/s/ Charles Parker

 

Charles Parker

 

Chief Financial Officer

 

(Principal Financial Officer and Principal Accounting Officer)

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