[10-Q] Traws Pharma, Inc. Quarterly Earnings Report

Rhea-AI Filing Summary

Traws Pharma, Inc. reported Q3 results showing a net loss of $3.96 million as R&D and G&A totaled $2.31 million and $1.74 million, respectively. Cash and cash equivalents were $6.42 million at September 30, 2025, with total assets of $12.44 million. Stockholders’ equity improved to $4.55 million, aided by a sharp reduction in warrant liabilities.

For the nine months, the company recorded net income of $16.61 million, driven primarily by a $26.66 million non‑cash gain from the change in fair value and reclassification of warrant liabilities, and recognition of $2.79 million in revenue upon the termination of a legacy license. Operating cash outflow was $15.43 million year‑to‑date.

The company entered an ATM Agreement authorizing sales of up to $50 million in common stock and raised $3.27 million net by issuing 1,627,050 shares. It also acquired IP assets from Viriom for $2.35 million in cash, adding a patent now carried at $2.57 million. Management disclosed “substantial doubt” about the company’s ability to continue as a going concern based on current cash projections.

Positive

• None.

Negative

• Going concern: Management disclosed “substantial doubt” about the company’s ability to continue as a going concern based on current cash projections.

Insights

Biotech equity analyst

Going concern risk dominates despite non-cash gains.

Traws Pharma posted a Q3 loss while year-to-date income reflects non-cash benefits from warrant revaluation and reclassification. Operating uses of cash were significant at $15.43M for the nine months, and cash ended at $6.42M, framing near-term funding needs for ongoing programs.

The filing states “substantial doubt” about continuing as a going concern, indicating reliance on external financing. The company has an ATM facility of up to $50M and raised $3.27M net under it, but further access depends on market conditions and share price dynamics.

While warrant liabilities fell to $11K by Sept 30, 2025 and equity turned positive at $4.55M, these are largely accounting effects. Near-term outcomes hinge on capital raises and R&D progress; the excerpt does not provide timing for clinical catalysts.

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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 September 30, 2025

​

Or

​

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

​

Commission file number: 001-36020

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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.

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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

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The number of outstanding shares of the registrant’s Common Stock, par value $0.01 per share, as of November 10, 2025 was 7,990,867.

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Table of Contents

TRAWS PHARMA, INC.

​

TABLE OF CONTENTS FOR QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2025

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​	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 Income (Loss)	5
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)	6
Condensed Consolidated Statements of Cash Flows	8
Notes to Condensed Consolidated Financial Statements	9
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	26
Item 3. Quantitative and Qualitative Disclosures About Market Risk	39
Item 4. Controls and Procedures	39
​	​
PART II — OTHER INFORMATION	​
​	​
Item 1. Legal Proceedings	40
Item 1A. Risk Factors	40
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	42
Item 3. Defaults Upon Senior Securities	42
Item 4. Mine Safety Disclosures	42
Item 5. Other Information	42
Item 6. Exhibits	43
SIGNATURES	44

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2

Table of Contents

PART I — FINANCIAL INFORMATION

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Item 1. Financial Statements

​

Traws Pharma, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

​

​	​	​	​	​	​	​	​
​	​	September 30,		​	December 31,		​
​	​	2025		​	2024		​
Assets	​	​		​	​	​	​
Current assets:	​	​	​	​	​	​	​
Cash and cash equivalents	​	$	6,420,000	​	$	21,338,000	​
Tax incentive and other receivables	​		1,991,000	​		1,765,000	​
Prepaid expenses and other assets	​		1,214,000	​		1,848,000	​
Total current assets	​		9,625,000	​		24,951,000	​
Property and equipment, net	​		7,000	​		10,000	​
Intangible assets, net	​	​	2,571,000	​	​	—	​
Other assets	​		240,000	​		1,000	​
Total assets	​	$	12,443,000	​	$	24,962,000	​
Liabilities and stockholders’ equity (deficit)	​	​	​	​	​	​	​
Current liabilities:	​	​	​	​	​	​	​
Accounts payable	​	$	5,105,000	​	$	8,186,000	​
Accrued expenses and other liabilities	​		2,782,000	​		3,121,000	​
Deferred revenue	​		—	​		226,000	​
Total current liabilities	​		7,887,000	​		11,533,000	​
Deferred revenue, non-current	​		—	​		2,565,000	​
Warrant liabilities	​		11,000	​		42,494,000	​
Total liabilities	​		7,898,000	​	​	56,592,000	​
​	​	​	​	​	​	​	​
Commitments and contingencies (Note 6)	​	​	​	​	​	​	​
​	​	​	​	​	​	​	​
Stockholders’ equity (deficit):	​	​	​	​	​	​	​
Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares issued, 6,737 and 7,398 shares outstanding at September 30, 2025 and December 31, 2024, respectively	​		—	​		—	​
Common stock, $0.01 par value, 250,000,000 shares authorized, 7,131,151 and 3,650,731 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively	​		71,000	​		36,000	​
Additional paid-in capital	​		637,009,000	​		617,530,000	​
Accumulated deficit	​		(632,541,000)	​		(649,154,000)	​
Accumulated other comprehensive income (loss)	​		6,000	​		(42,000)	​
Total stockholders’ equity (deficit)	​		4,545,000	​		(31,630,000)	​
Total liabilities and stockholders’ equity (deficit)	​	$	12,443,000	​	$	24,962,000	​

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See accompanying notes to condensed consolidated financial statements.

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3

Table of Contents

Traws Pharma, Inc.

Condensed Consolidated Statements of Operations (unaudited)

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​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended September 30,

​

Nine Months Ended September 30,

​

​

2025

2024

2025

2024

Revenue

​

$

—

​

$

57,000

​

$

2,790,000

​

$

170,000

​

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

​

Acquired in-process research and development

​

—

​

—

​

—

​

117,464,000

​

Research and development

​

2,311,000

​

5,113,000

​

7,108,000

​

10,989,000

​

General and administrative

​

1,744,000

​

3,480,000

​

6,189,000

​

8,813,000

​

Total operating expenses

​

4,055,000

​

8,593,000

​

13,297,000

​

137,266,000

​

Loss from operations

​

(4,055,000)

​

(8,536,000)

​

(10,507,000)

​

(137,096,000)

​

Change in fair value of warrant liability

​

​

(3,000)

​

​

—

​

​

26,656,000

​

​

—

​

Other income, net

​

96,000

​

61,000

​

464,000

​

495,000

​

Net (loss) income

​

$

(3,962,000)

​

$

(8,475,000)

​

$

16,613,000

​

$

(136,601,000)

​

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

​

$

(3,035,000)

​

$

(1,433,000)

​

$

12,263,000

​

$

(33,255,000)

​

Weighted-average shares of common stock outstanding, basic

​

​

8,818,859

​

​

961,530

​

​

7,851,515

​

​

1,043,781

​

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

​

$

(0.34)

​

$

(1.49)

​

$

1.56

​

$

(31.86)

​

Weighted-average shares of common stock outstanding, diluted

​

​

8,818,859

​

​

961,530

​

​

8,006,487

​

​

1,043,781

​

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

​

$

(0.34)

​

$

(1.49)

​

$

1.53

​

$

(31.86)

​

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

​

$

(927,000)

​

$

(7,042,000)

​

$

4,350,000

​

$

(103,346,000)

​

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

​

​

6,737

​

​

11,816

​

​

6,962

​

​

8,109

​

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

​

$

(137.60)

​

$

(595.97)

​

$

624.82

​

$

(12,744.60)

​

​

See accompanying notes to condensed consolidated financial statements.

​

4

Table of Contents

Traws Pharma, Inc.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(unaudited)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended September 30,

​

Nine Months Ended September 30,

​

​

2025

2024

2025

2024

Net (loss) income

​

$

(3,962,000)

​

$

(8,475,000)

​

$

16,613,000

​

$

(136,601,000)

​

Other comprehensive (loss) income

​

​

​

​

​

​

​

​

​

​

​

​

​

Foreign currency translation adjustments

​

(3,000)

​

—

​

48,000

​

(10,000)

​

Other comprehensive (loss) income

​

​

(3,000)

​

​

—

​

​

48,000

​

​

(10,000)

​

Comprehensive (loss) income

​

$

(3,965,000)

​

$

(8,475,000)

​

$

16,661,000

​

$

(136,611,000)

​

​

See accompanying notes to condensed consolidated financial statements.

​

​

​

5

Table of Contents

Traws Pharma, Inc.

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

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Month Periods Ended September 30, 2025 and 2024

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Accumulated

​

​

​

​

​

Redeemable Convertible

​

​

​

​

​

​

​

​

​

​

​

​

​

Additional

​

​

​

​

other

​

​

​

​

​

Preferred Stock

​

​

Preferred Stock

​

​

Common Stock

​

Paid in

​

Accumulated

​

comprehensive

​

​

​

​

Shares

Amount

​

Shares

Amount

​

Shares

Amount

Capital

deficit

(loss) income

Total

Balance at June 30, 2025

​

—

​

$

—

​

​

6,737

​

$

—

​

​

7,069,148

​

$

71,000

​

$

636,761,000

​

$

(628,579,000)

​

$

9,000

​

$

8,262,000

Stock-based compensation

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

​

135,000

​

​

—

​

​

—

​

​

135,000

Issuance of common stock, net of offering costs

​

—

​

​

—

​

​

—

​

​

—

​

​

62,003

​

​

—

​

​

113,000

​

​

—

​

​

—

​

​

113,000

Other comprehensive income

​

—

​

—

​

​

—

​

​

—

​

​

—

​

—

​

​

—

​

​

—

​

(3,000)

​

​

(3,000)

Net loss

—

​

—

​

​

—

​

​

—

​

​

—

​

—

​

—

​

(3,962,000)

​

—

​

(3,962,000)

Balance at September 30, 2025

​

—

​

$

—

​

​

6,737

​

$

—

​

​

7,131,151

​

$

71,000

​

$

637,009,000

​

$

(632,541,000)

​

$

6,000

​

$

4,545,000

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Balance at June 30, 2024

​

12,472

​

$

111,619,000

​

​

—

​

$

—

​

​

1,012,381

​

$

10,000

​

$

505,260,000

​

$

(610,757,000)

​

$

(33,000)

​

$

(105,520,000)

Conversion of redeemable convertible preferred stock upon stockholder approval

​

(12,472)

​

​

(111,619,000)

​

​

7,440

​

​

—

​

​

2,012,973

​

​

20,000

​

​

111,599,000

​

​

—

​

​

—

​

​

111,619,000

Stock-based compensation

—

​

—

​

​

—

​

—

​

​

—

​

—

​

343,000

​

—

​

—

​

343,000

Shares issued for vested restricted stock units

​

—

​

—

​

​

—

​

—

​

​

200

​

—

​

—

​

—

​

—

​

—

Net loss

—

​

—

​

​

—

​

​

—

​

​

—

​

—

​

—

​

(8,475,000)

​

—

​

(8,475,000)

Balance at September 30, 2024

​

—

​

$

—

​

​

7,440

​

$

—

​

​

3,025,554

​

$

30,000

​

$

617,202,000

​

$

(619,232,000)

​

$

(33,000)

​

$

(2,033,000)

​

See accompanying notes to condensed consolidated financial statements.

​

6

Table of Contents

Traws Pharma, Inc.

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

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Nine Month Periods Ended September 30, 2025 and 2024

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Accumulated

​

​

​

​

​

Redeemable Convertible

​

​

​

​

​

​

​

​

​

​

​

​

​

Additional

​

​

​

​

other

​

​

​

​

​

Preferred Stock

​

​

Preferred Stock

​

​

Common Stock

​

Paid in

​

Accumulated

​

comprehensive

​

​

​

​

Shares

Amount

​

Shares

Amount

​

Shares

Amount

Capital

deficit

income (loss)

Total

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

—

​

—

​

​

—

​

—

​

​

—

​

—

​

401,000

​

—

​

—

​

401,000

Stock issued for vested restricted stock units

​

—

​

​

—

​

​

—

​

​

—

​

​

6,509

​

​

—

​

​

—

​

​

—

​

—

​

​

—

Issuance of common stock, net of offering costs

​

—

​

​

—

​

​

—

​

​

—

​

​

1,627,050

​

​

16,000

​

​

3,254,000

​

​

—

​

​

—

​

​

3,270,000

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

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

​

15,827,000

​

​

—

​

​

—

​

​

15,827,000

Exercise of prefunded warrants

​

—

​

​

—

​

​

—

​

​

—

​

​

1,582,559

​

​

16,000

​

​

—

​

​

—

​

​

—

​

​

16,000

Conversion of Series C Preferred shares into common stock

​

—

​

—

​

​

(661)

​

​

—

​

​

264,302

​

​

3,000

​

​

(3,000)

​

​

—

​

​

—

​

​

—

Other comprehensive income

—

​

—

​

​

—

​

—

​

​

—

​

—

​

—

​

—

​

48,000

​

48,000

Net income

—

​

—

​

​

—

​

—

​

​

—

​

—

​

—

​

16,613,000

​

—

​

16,613,000

Balance at September 30, 2025

​

—

​

$

—

​

​

6,737

​

$

—

​

​

7,131,151

​

$

71,000

​

$

637,009,000

​

$

(632,541,000)

​

$

6,000

​

$

4,545,000

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Balance at December 31, 2023

​

—

​

$

—

​

​

—

​

$

—

​

​

840,251

​

$

9,000

​

$

493,317,000

​

$

(482,631,000)

​

$

(23,000)

​

$

10,672,000

Issuance of stock in connection with the asset acquisition of Trawsfynydd

​

10,359

​

​

93,232,000

​

​

—

​

​

—

​

​

141,982

​

​

1,000

​

​

3,549,000

​

​

—

​

​

—

​

​

3,550,000

Transaction costs paid through the issuance of stock

​

535

​

​

4,815,000

​

​

—

​

​

—

​

​

6,747

​

​

—

​

​

169,000

​

​

—

​

​

—

​

​

169,000

Issuance of stock in connection with the private placement, net of expenses

​

1,578

​

​

13,572,000

​

​

—

​

​

—

​

​

19,879

​

​

—

​

​

427,000

​

​

—

​

​

—

​

​

427,000

Exchange of Trawsfynydd stock options for options of the Company

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

​

7,085,000

​

​

—

​

​

—

​

​

7,085,000

Conversion of redeemable convertible preferred stock upon stockholder approval

​

(12,472)

​

​

(111,619,000)

​

​

7,440

​

​

—

​

​

2,012,973

​

​

20,000

​

​

111,599,000

​

​

—

​

​

—

​

​

111,619,000

Stock-based compensation

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

—

​

1,056,000

​

—

​

—

​

1,056,000

Shares issued for vested restricted stock units

​

—

​

​

—

​

​

—

​

​

—

​

​

3,722

​

​

—

​

​

—

​

​

—

​

—

​

—

Other comprehensive loss

​

—

​

​

—

​

​

—

​

​

—

​

​

—

​

—

​

—

​

—

​

(10,000)

​

(10,000)

Net loss

—

​

​

—

​

​

—

​

​

—

​

​

—

​

—

​

—

​

(136,601,000)

​

—

​

(136,601,000)

Balance at September 30, 2024

​

—

​

$

—

​

​

7,440

​

$

—

​

​

3,025,554

​

$

30,000

​

$

617,202,000

​

$

(619,232,000)

​

$

(33,000)

​

$

(2,033,000)

​

​

​

​

​

7

Table of Contents

Traws Pharma, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

​

​	​	​	​	​	​	​	​
​	​	Nine Months Ended September 30,					​
​		2025			2024
Operating activities:	​	​	​	​	​	​	​
Net income (loss)	​	$	16,613,000	​	$	(136,601,000)	​
Adjustments to reconcile net loss to net cash used in operating activities:	​	​	​	​	​	​	​
Acquired in-process research and development	​	​	—	​	​	117,464,000	​
Change in fair value of warrant liability	​	​	(26,656,000)	​	​	—	​
Depreciation and amortization	​		17,000	​		10,000	​
Stock-based compensation	​		401,000	​		1,056,000	​
Changes in assets and liabilities:	​	​	​	​	​	​	​
Receivables	​		(226,000)	​		(2,103,000)	​
Prepaid expenses and other current assets	​		634,000	​		429,000	​
Accounts payable	​		(3,081,000)	​		(147,000)	​
Accrued expenses and other current liabilities	​		(339,000)	​		(5,690,000)	​
Deferred revenue	​		(2,790,000)	​		(170,000)	​
Net cash used in operating activities	​		(15,427,000)	​		(25,752,000)	​
​	​	​	​	​	​	​	​
Investing activities:	​	​	​	​	​	​	​
Purchase of intangible assets	​	​	(2,585,000)	​	​	—	​
Cash paid for acquisition, net of cash acquired	​	​	—	​	​	(3,648,000)	​
Net cash used in investing activities	​		(2,585,000)	​		(3,648,000)	​
​	​	​	​	​	​	​	​
Financing activities:	​	​	​	​	​	​	​
Proceeds from sale of common stock with the private placement, net of expenses	​	​	—	​	​	13,999,000	​
Proceeds from sale of common stock pursuant to the ATM	​	​	3,495,000	​	​	—	​
Payment of offering costs	​	​	(465,000)	​	​	—	​
Proceeds from exercised prefunded warrants	​	​	16,000	​	​	—	​
Net cash provided by financing activities	​		3,046,000	​		13,999,000	​
Effect of foreign currency translation on cash	​		48,000	​		(10,000)	​
Net decrease in cash and cash equivalents	​		(14,918,000)	​		(15,411,000)	​
Cash and cash equivalents at beginning of period	​		21,338,000	​		20,821,000	​
Cash and cash equivalents at end of period	​	$	6,420,000	​	$	5,410,000	​
Supplemental disclosure of cash flow information:	​	​	​	​	​	​	​
Reclassification of warrant liability upon exercise of prefunded warrants and amended warrant agreements	​	$	15,827,000	​	$	—	​
Preferred stock issued in connection with reclassification and conversion of redeemable convertible preferred stock	​	​	—	​	​	111,619,000	​
Common stock issued in connection with acquisition of Trawsfyndd	​	$	—	​	​	3,719,000	​
Redeemable convertible preferred stock issued in connection with acquisition of Trawsfyndd	​	$	—	​	​	98,047,000	​

​

See accompanying notes to condensed consolidated financial statements.

​

​

8

Table of Contents

1. Nature of Business

​

The Company

​

Traws Pharma, Inc. (“Traws Pharma” or the “Company”), formerly known as Onconova Therapeutics, Inc., was incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The Company's headquarters are located in Newtown, Pennsylvania. On April 1, 2024, the Company acquired Trawsfynydd Therapeutics, Inc., a Delaware corporation (“Trawsfynydd”), through a merger (the “Merger”) and the name change to Traws Pharma was effected. The Company accounted for the transaction as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated in two programs that were grouped as a single identifiable in-process research and development (“IPR&D”) asset. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Following the Merger, the Company has four clinical programs: (i) tivoxavir marboxil, an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza; (ii) ratutrelvir, an inhibitor of the main protease (also known as 3CL protease) of the SAR-CoV-2 virus, the causative agent in COVID19; (iii) narazaciclib (ON 123300), a multi-targeted kinase inhibitor in solid tumors and hematological malignancies as a single agent or in combination with other anti-cancer therapies; and (iv) rigosertib, administered alone or in combination for investigation in various cancers. The Company’s primary focus is the development of tivoxavir marboxil and ratutrelvir, and its strategic objective for narazaciclib and rigosertib is to establish additional partnerships for further development of the compounds.  

​

Reverse Stock Split

​

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

​

Liquidity

​

The Company has incurred recurring operating losses since inception. As of September 30, 2025, the Company had an accumulated deficit of $632,541,000. 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 September 30, 2025, the Company had cash and cash equivalents of $6,420,000. 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.

9

Table of Contents

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

​

Nasdaq Compliance

​

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

​

​

2. Summary of Significant Accounting Policies

​

Basis of Presentation

​

The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company and its wholly-owned subsidiaries, Trawsfynydd Therapeutics LLC, Trawsfynydd Therapeutics AU Ltd, Throxavir Therapeutics AU Pty Ltd and Onconova Europe GmbH. 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 September 30, 2025, the condensed consolidated statements of operations and comprehensive (loss) income for the three and nine months ended September 30, 2025 and 2024, the consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three and nine months ended September 30, 2025 and 2024 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2025, the results of its operations for the three and nine months ended September 30, 2025 and 2024, and its cash flows for the nine months ended September 30, 2025 and 2024. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2025 and 2024 are unaudited. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period.  These unaudited condensed consolidated financial statements should be read in conjunction with the audited

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consolidated financial statements and the notes thereto for the year ended December 31, 2024 included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2024 (“Annual Report”), filed with the SEC on March 31, 2025.

​

Segment Information

​

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company has one operating segment. The Company’s chief operating decision maker (“CODM”) is the interim chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All the Company’s long-lived assets are held in the United States.

​

Concentrations of Credit Risk and Off-Balance Sheet Risk

​

Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains a portion of its cash and cash equivalent balances in the form of money market accounts with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance sheet risk of loss.

​

At September 30, 2025, the Company had $5,788,000 of its cash and cash equivalents in money market funds that invest in a portfolio of liquid, high-quality debt securities issued by the U.S. government.

​

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

​

Significant Accounting Policies

​

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

​

Tax Incentive Receivable

​

The Company is eligible to receive a cash refund from the Australian Taxation Office for eligible research and development (“R&D”) expenditures under the Australian Research and Development Tax Incentive Program (the “Australian Tax Incentive”). The Australian Tax Incentive is recognized as a reduction to R&D expense when the relevant expenditure has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company’s Australian subsidiaries began operations in the second quarter of 2024, and the Company has recognized reductions to R&D expenses of $447,000 and $510,000 for the three and nine months ended September 30, 2025. The Company recognized reductions to R&D expenses of $1,804,000 for the three and nine months ended September 30, 2024.

​

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

11

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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 and nine months ended September 30, 2025 or 2024.

​

Intangible Assets

​

Intangible assets consist entirely of patents. Costs related to patents, which include legal and application fees, are capitalized and amortized over the estimated useful lives using the straight-line method. Patent amortization commences once final approval of the patent has been obtained. For patents purchased in an asset acquisition, the useful life is determined largely by valuation estimates of remaining economic life. The Company’s patent, purchased in connection with the Purchased Assets from Viriom, Inc. (“Viriom”) (Note 3), has a useful life of 15 years.

​

Fair Value of Financial Instruments

​

The Company accounts for financial instruments under ASC 820, Fair Value Measurements (“ASC 820”). This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels as follows:

​

Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities;

​

Level 2 — observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and

​

Level 3 — assets and liabilities whose significant value drivers are unobservable.

​

The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, 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
September 30, 2025	(Level 1)		​	(Level 2)		​	(Level 3)
Assets:	​	​	​	​	​	​	​	​
Cash equivalents - money market funds	$	5,788,000	​	$	-	​	$	-
Liabilities:		​			​			​
Warrant liabilities - Series A Warrants	$	-	​	$	-	​	$	11,000
​	​	​	​	​	​	​	​	​
December 31, 2024	​	​	​	​	​	​	​	​
Assets:	​	​	​	​	​	​	​	​
Cash equivalents - money market funds	$	20,508,000	​	$	-	​	$	-
Liabilities:		​			​			​
Warrant liabilities - Series A Warrants	$	-	​	$	-	​	$	13,125,000
Warrant liabilities - Pre-funded Warrants	$	-	​	$	29,369,000	​	$	-

​

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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:

​

​	​	​	​	​	​
​	​	September 30, 2025	​	​	December 31, 2024 (Issuance date)
Expected term of warrants (years)	​	0.75 year	​	​	1 year
Risk-free interest rate	​	3.8%	​	​	4.2%
Expected volatility	​	101.9%	​	​	126.9%
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 and nine months ended September 30, 2025, is as follows:

​

​	​	​
Balance, December 31, 2024	$	42,494,000
Change in fair value	​	(26,513,000)
Reclassification of warrant liability upon exercise of pre-funded warrants	​	(6,694,000)
Reclassification of warrant liability upon amendment of Series A Warrant agreements	​	(9,133,000)
Balance, March 31, 2025	​	154,000
Change in fair value of Series A Warrants	​	(146,000)
Balance, June 30, 2025	​	8,000
Change in fair value of Series A Warrants	​	3,000
Balance, September 30, 2025	$	11,000

​

On February 18, 2025, the Company and certain of the purchasers entered into amendments to the Series A Warrants, pursuant to which the Series A Warrant liability attributable to the Series A Warrants held by such purchasers was reclassified to permanent equity. The change in fair value of the warrant liability related to the Series A Warrants was measured using the fair value of the amended Series A Warrants immediately prior to February 18, 2025.

​

During the first quarter of 2025, certain purchasers exercised their pre-funded warrants for an aggregate of 1,382,559 shares of the Company’s common stock. On March 27, 2025, the Company and those purchasers holding all pre-funded warrants outstanding as of such date entered into amendments to the pre-funded warrants, pursuant to which the pre-funded warrant liability was reclassified to permanent equity.

​

The change in warrant liability during the three months ended September 30, 2025 was due to the change in fair value of the outstanding liability classified Series A Warrants.

​

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Revenues and Deferred Revenues

​

Effective April 17, 2025, the Company and Symbio Pharmaceuticals Limited (“Symbio”) mutually terminated the license agreement originally entered into by and between the parties in 2011. No payments, compensation, reimbursements or settlements shall be due or owed by either party in connection with the termination of the license agreement. As a result, the Company recognized the $2,733,000 of deferred revenue as revenue on April 17, 2025.

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended September 30,

​

Nine Months Ended September 30,

​

​

2025

2024

2025

2024

Symbio

​

​

​

​

​

​

​

​

​

​

​

​

​

Upfront license fee recognition over time

​

$

—

​

$

57,000

​

$

2,790,000

​

$

170,000

​

​

Deferred revenue is as follows:

​

​	​	​	​
​	​	Symbio
​		Upfront Payment
Deferred balance at December 31, 2024	​	$	2,790,000
Recognition of revenue	​	​	(2,790,000)
Deferred balance at September 30, 2025	​	$	—

​

Research and Development Expenses

​

R&D costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and costs associated with preclinical activities and regulatory operations.

​

Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued R&D expense, as the case may be.

Net (loss) income per share

During the current fiscal year, management identified an immaterial error related to the calculation and presentation of loss per share in prior periods. The Company had previously incorrectly concluded that the Company’s Series C Non-Voting Convertible Preferred (“Series C Preferred”) shares had preferences over the Company’s common stock and were therefore excluded from the calculation of basic and diluted net loss per share pursuant to the two-class method. Net loss per share attributable to common stockholders for the three and nine months ended September 30, 2024 as previously presented was $8.81 and $130.87, respectively, and as corrected is $1.49 and $31.86, respectively. Net loss per share attributable to holders of Series C Preferred was not previously presented. All related amounts have been updated to reflect the effects of the correction in the consolidated statement of operations and related notes, as applicable. The correction of this error had no impact on the previously reported net loss or cash flows.

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. Income (losses) are allocated between the common shares and the Series C Preferred on a pro rata basis, as they share equally in (losses) income and residual net assets on an as-converted basis.

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Basic income (loss) 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.

​

For the three and nine months ended September 30, 2025, and 2024, the components of basic and diluted net (loss) income per share were as follows:

​

​	​	​	​	​	​	​	​	​	​	​	​
​	Three Months Ended September 30,					​	Nine Months Ended September 30,
(in thousands except per share amounts)	2025			2024		​	2025			2024
Numerator:	​	​	​	​	​	​	​	​	​	​	​
Net (loss) income	$	(3,962,000)	​	$	(8,475,000)	​	$	16,613,000	​	$	(136,601,000)
​	​	​	​	​	​	​	​	​	​	​	​
Net (loss) income attributable to common stockholders	$	(3,035,000)	​	$	(1,433,000)	​	$	12,263,000	​	$	(33,255,000)
Net (loss) income attributable to Series C Preferred stockholders	$	(927,000)	​	$	(7,042,000)	​	$	4,350,000	​	$	(103,346,000)
​	​	​	​	​	​	​	​	​	​	​	​
Denominator:	​	​	​	​	​	​	​	​	​	​	​
Weighted-average shares of common stock outstanding, basic	​	8,818,859	​	​	961,530	​	​	7,851,515	​	​	1,043,781
Restricted stock units	​	-	​	​	-	​	​	1,844	​	​	-
Stock options	​	-	​	​	-	​	​	153,128	​	​	-
Weighted-average shares of common stock outstanding, diluted	​	8,818,859	​	​	961,530	​	​	8,006,487	​	​	1,043,781
​	​	​	​	​	​	​	​	​	​	​	​
Net (loss) income per share of common stock, basic	$	(0.34)	​	$	(1.49)	​	$	1.56	​	$	(31.86)
Net (loss) income per share of common stock, diluted	$	(0.34)	​	$	(1.49)	​	$	1.53	​	$	(31.86)
​	​	​	​	​	​	​	​	​	​	​	​
Weighted-average shares of Series C Preferred outstanding, basic and diluted	​	6,737	​	​	11,816	​	​	6,962	​	​	8,109
Net (loss) income per share of Series C Preferred, basic and diluted	$	(137.60)	​	$	(595.97)	​	$	624.82	​	$	(12,744.60)
​	​	​	​	​	​	​	​	​	​	​	​

​

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:

​

​	​	​	​	​
​	​	September 30,
​		2025		2024
Warrants		3,919,589		12,310
Stock Options		398,330		430,066
Unvested restricted stock units		23,671		22,421
Series C Preferred (as converted to common stock)	​	2,694,800	​	2,976,138
​		7,036,390		3,440,935

​

The Series C Preferred were previously classified as redeemable convertible preferred stock due to certain redemption rights provided for by the Certificate of Designation for the Series C Preferred. The redemption rights expired in connection with the Company obtaining the affirmative stockholder vote on the Conversion Proposal (defined below) in September 2024. Immediately following the stockholder vote, any outstanding shares of Series C Preferred not converted were reclassified as permanent equity within the Company’s consolidated balance sheet.

​

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Recently Issued but not yet Adopted Accounting Pronouncements

​

In December 2023, the Financial Accounting Standards Board (the “FASB”) issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which expands the disclosure required for income taxes. This ASU is effective for fiscal years beginning after December 16, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the effect of this ASU on its disclosures.

​

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the consolidated statement of operations. The guidance in this ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.

​

​

3. Asset Acquisition

​

Viriom

​

On September 9, 2025, the Company and Viriom, a related party (Note 11), entered into an Asset Purchase Agreement (the “Purchase Agreement”), pursuant to which the Company purchased certain assets (the “Purchased Assets”) from Viriom in exchange for $2,350,000 in cash. The Purchased Assets include certain intellectual property and other assets related to a pyrrolidine antiviral compound (the “Compound”), Viriom’s program pipeline related thereto (the “Program”) and any pharmaceutical product containing or comprising the Compound (a “Product”), including without limitation certain patents and patent applications; all other intellectual property controlled by Viriom related to the Program, Compound and Product; a third-party license agreement and rights and obligations related thereto; any and all material regulatory or similar filings, applications or associated correspondence related to the development, manufacture of commercialization of the Compound or product; all materials owned or controlled by Viriom related to the Program, Compound or Product; and certain other related assets.

​

The Company concluded that the acquisition of the Purchased Assets was not a business combination as the purchased assets did not meet the definition of a business under ASC 805, Business Combinations. Therefore, the Company accounted for the Purchase Agreement and the transactions contemplated thereby under the authoritative guidance for asset acquisitions, and allocated the costs of the acquisition of $2,350,000 and legal costs incurred in consummating the Purchase Agreement of $235,000 to the acquired patent. The patent has a useful life of 15 years and will be amortized on a straight-line basis over this period, as the economic benefits are expected to be realized evenly over the patent’s useful life.

​

Trawsfynydd

​

On April 1, 2024, the Company acquired Trawsfynydd, in accordance with the terms of an Agreement and Plan of Merger, dated April 1, 2024 (the “Merger Agreement”), pursuant to which the Company acquired Trawsfynydd’s tivoxavir marboxil and ratutrelvir programs and assumed certain liabilities associated with the acquired assets. The upfront consideration included (i) the issuance of 141,982 shares of common stock of the Company at an aggregate fair value of $3,550,000, (ii) the issuance of 10,359 shares of Series C Preferred at an aggregate fair value of $93,232,000, and (iii) the assumption of all Trawsfynydd stock options (the “assumed options”) immediately outstanding prior to the transaction at an aggregate fair value of $7,085,000.

​

Each share of Series C Preferred is convertible into 400 shares of common stock, subject to the Beneficial Ownership Limitation (defined below). The fair value of the shares issued to Trawsfynydd and options assumed was based

16

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on the closing stock price of the Company’s common stock on April 1, 2024 of $1.00, less a 10.0% discount related to unregistered share restrictions of the Series C Preferred shares.

​

The Company accounted for the transaction as an asset acquisition as the Company acquired inputs and no substantive processes or outputs. The assets acquired in the transaction were measured based on the estimated fair value of the consideration paid of $112,543,000, which included direct transactions costs of $8,676,000. Tungsten Partners LLC (“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As partial compensation for services rendered by Tungsten, the Company issued to Tungsten and its affiliates and designees an aggregate of 6,747 shares of common stock and 535 shares of Series C Preferred.

​

The consideration paid and the relative fair values of the assets acquired and liabilities assumed were as follows:

​

​	​	​	​
Consideration transferred:	​	​	​
Common stock	​	$	3,550,000
Series C Preferred	​	​	93,232,000
Assumed options	​	​	7,085,000
Company transaction costs settled in equity	​	​	4,984,000
Company transaction costs paid in cash	​	​	3,692,000
Total consideration transferred	​	$	112,543,000
​	​	​	​
Assets acquired:	​	​	​
Cash and cash equivalents	​	$	44,000
Total assets acquired	​	$	44,000
​	​	​	​
Liabilities assumed:	​	​	​
Accrued expenses and other current liabilities	​	$	4,965,000
Total liabilities assumed	​	​	4,965,000
Net assets acquired	​	​	(4,921,000)
In-process research and development	​	​	117,464,000
Net assets acquired	​	$	112,543,000

​

The Company’s board of directors (“Board”) approved the Merger Agreement and the related transactions, and the consummation of the Merger was not subject to approval of Company stockholders. In accordance with the Merger Agreement, three directors were appointed to the Board, and there were several changes to management, each effective as of the closing of the Merger.

​

Concurrently with the closing of the Merger, the Company entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of Company common stock as of the applicable record date (April 15, 2024), including those holders receiving shares of common stock in connection with the Merger, is entitled to one contractual contingent value right (each, a “CVR”) entitling the holder to certain distributions of net proceeds and net sales of the Company’s two leading oncology drug candidates, subject to, and in accordance with, the terms and conditions of the CVR Agreement, for each share of common stock held by such holder as of the applicable record time.

​

The distributions in respect of the CVRs will be made on a quarterly basis, and will be subject to a number of deductions, subject to certain exceptions or limitations, including but not limited to, for certain taxes and certain out-of-pocket expenses incurred by the Company. At the time of the Merger and again at September 30, 2025, the value ascribed to the CVR liability was de minimis given the uncertainty related to the success of the underlying oncology programs.

​

​

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4. Balance Sheet Detail

​

Prepaid expenses and other current assets:

​

​	​	​	​	​	​	​	​
​	​	September 30,		​	December 31,		​
​		2025			2024		​
Research and development	​	$	790,000	​	$	1,514,000	​
Insurance	​		332,000	​		156,000	​
Other	​		92,000	​		178,000	​
​	​	$	1,214,000	​	$	1,848,000	​

​

Property and equipment:

​

​	​	​	​	​	​	​
​	​	September 30,		​	December 31,
​		2025			2024
Computer and office equipment	​	$	84,000	​	$	84,000
Less accumulated depreciation	​		(77,000)	​		(74,000)
​	​	$	7,000	​	$	10,000

​

Accrued expenses and other current liabilities:

​

​	​	​	​	​	​	​	​
​	​	September 30,		​	December 31,		​
​		2025			2024		​
Research and development	​	$	1,869,000	​	$	2,331,000	​
Employee compensation	​		774,000	​		265,000	​
Professional fees	​	​	139,000	​	​	525,000	​
​	​	$	2,782,000	​	$	3,121,000	​

​

​

5. Intangible Assets

​

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

​

​	​	​	​	​	​	​	​	​	​	​
​	​	September 30,
​	​	2025
​	​	Gross		​	​	Accumulated Amortization		​	Net
Patent	​	$	2,585,000	​	​	$	(14,000)	​	$	2,571,000

​

Total amortization expense for the patent was $14,000 for the three and nine months ended September 30, 2025. There was no amortization expense for the three and nine months ended September 30, 2024.

​

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

​

​	​	​	​
Years Ending December 31:	​	​	​
2025 (remaining 3 months)	​	$	43,000
2026	​	​	172,000
2027	​	​	172,000
2028	​	​	172,000
2029	​	​	172,000
Thereafter	​	​	1,840,000
​	​	$	2,571,000

​

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6. 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 September 30, 2025.

On June 17, 2024, Steven M. Fruchtman informed the Board of his intent to resign from his positions as President and Chief Scientific Officer, Oncology and indicated to the Company that Dr. Fruchtman believes his resignation to be for "good reason" under the terms of his employment agreement and his expectation of compensation commensurate therewith and in connection with a change in control. The Board accepted Dr. Fruchtman’s resignation effective immediately but disagrees with the characterization of the events set forth in the letter. The Company believes that no severance payments are due to Dr. Fruchtman under the terms of his employment agreement as it pertains to termination for good reason events. The claims have been submitted to arbitration for resolution, and arbitration proceedings are currently scheduled to commence on June 1, 2026. At September 30, 2025, 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. Refer to discussion of Contingent Value Rights within Note 3.

​

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

​

In connection with the acquisition of Trawsfynydd and the concurrent private placement of securities in April 2024 (Note 3), the Company issued shares of Series C Preferred to various individuals. Except in limited circumstances, Series C Preferred shares have no voting rights. At September 30, 2025, there were 6,737 shares of Series C Preferred outstanding. Certain material provisions of the Series C Preferred are as follows:

​

Conversion: Each share of Series C Preferred is convertible into 400 shares of Company common stock, subject to the Beneficial Ownership Limitation.

​

Dividends: Shares of Series C Preferred participate in any dividends with common stockholders on an as-converted basis

​

Liquidation: In the event of the liquidation, dissolution, or winding up of the affairs of the Company, whether voluntary or involuntary, the holders of Series C Preferred shall rank on parity with common stockholders as to the 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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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 nine months ended September 30, 2025, the Company sold and issued an aggregate of 1,627,050 shares of its common stock under the ATM Agreement for net proceeds of $3,270,000.

Amendment of Series A Warrants and Pre-funded Warrants

​

On February 18, 2025, the Company and certain of the purchasers of Units in the equity offering that closed on December 31, 2024 (the “December 2024 Offering”) entered into amendments to the Series A Warrants (the “Series A Warrant Amendment”), pursuant to which the Series A Warrants issued to such purchasers were amended to (i) increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the expected volatility rate to be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be utilized for calculating consideration payable to the holders of the Series A Warrants in connection with a Fundamental Transaction that is not within the Company’s control, and (iii) remove Section 3(h) of the Series A Warrants, which, under certain circumstances, provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse stock split, stock consolidation, or a recapitalization or similar event involving the Company’s common stock based on the volume weighted average price of the Company’s common stock over 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 nine months ended September 30, 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 nine months ended September 30, 2025.

​

8. Warrants

​

Common stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging - Contracts in Entity’s Own Equity (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. The conditions within ASC 815-40 are not subject to a probability assessment. The equity classified warrants do not fall under the liability criteria within ASC 480 Distinguishing Liabilities from Equity, as they are not puttable and do not represent an instrument that has a redeemable underlying security. The equity classified warrants do meet the definition of a derivative instrument under ASC 815, but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding. The Series A Warrants and pre-funded warrants issued in connection with the December 2024 Offering did not meet the scope exception under ASC 815 and, therefore, were classified as liabilities as of December 31, 2024. As a result of the Series A Amendment and PFW Amendment, 3,375,457 outstanding Series A Warrants and 1,928,493 outstanding pre-funded warrants met the scope exception under ASC 815 and, therefore, were reclassified to permanent equity during the nine months ended September 30, 2025.

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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 nine months ended September 30, 2025 is as follows:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Balance

​

​

​

Balance

​

​

​

​

Exercise

​

Expiration

​

December 31,

​

Warrants

​

September 30,

Description

Classification

Price

Date

2024

Exercised

2025

Non-tradable pre-funded warrants

​

Equity

​

$

56.25

​

none

​

141

​

—

​

141

Non-tradable pre-funded warrants

​

Equity

​

$

56.25

​

none

​

199

​

—

​

199

Non-tradable pre-funded warrants

​

Equity

​

$

0.01

​

none

​

3,311,052

​

(1,582,559)

​

1,728,493

Series A Warrants

​

Liability

​

$

13.42

​

Variable

​

543,792

​

—

​

543,792

Series A Warrants

​

Equity

​

$

13.42

​

Variable

​

3,375,457

​

—

​

3,375,457

​

​

​

​

​

​

​

​

​

7,230,641

​

(1,582,559)

​

5,648,082

​

​

9. Stock-Based Compensation

In 2021, the Company adopted its 2021 Incentive Compensation Plan, which was subsequently amended and restated in each of 2022 and 2024 (as amended and restated, the “2021 Plan”). Upon adopting the 2021 Plan, no further awards have been or will be made under the Company’s 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”). Under the 2021 Plan, the Company may grant incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards to employees, non-employee directors, consultants, and advisors. At September 30, 2025, there were 230,802 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 and nine months ended September 30, 2025, and 2024:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended September 30,

​

Nine Months Ended September 30,

​

​

2025

2024

2025

2024

Research and development

​

$

17,000

​

$

17,000

​

$

50,000

​

$

164,000

​

General and administrative

​

​

118,000

​

​

326,000

​

​

351,000

​

​

892,000

​

Total stock-based compensation expense

​

$

135,000

​

$

343,000

​

$

401,000

​

$

1,056,000

​

​

A summary of stock option activity for the nine months ended September 30, 2025 is as follows:

​

​	​	​	​	​	​	​	​	​	​	​
​		Options Outstanding
​	​	​	​	​	​	​	Weighted	​	​	​
​	​	​	​	Weighted-		​	Average	​	​
​	​	​	​	Average		​	Remaining	​	Aggregate
​	​	Number	​	Exercise		​	Contractual	​	Intrinsic
​		of Shares		Price			Term (in years)		Value
Balance, December 31, 2024		423,107	​	$	11.89		8.75	​	$	2,698,000
Granted		152,742	​	$	2.77	​	​	​	​	​
Forfeitures		(1,333)	​	$	17.67	​	​	​	​	​
Expired		(23,058)	​	$	118.99	​	​	​	​	​
Balance, September 30, 2025		551,458	​	$	4.98	​	8.25	​	$	85,000
Exercisable at September 30, 2025		407,646	​	$	5.66	​	7.83	​	$	67,000

​

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, 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 September 30, 2025, there was $171,000 of unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 0.90 years.

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

​

​	​	​	​	​	​	​	​	​
​	​	Nine Months Ended September 30,					​	​
​		2025			2024
Risk-free interest rate		​	4.17	%	​	3.46	%
Expected volatility		​	120.47	%	​	117.90	%
Expected term		​	5.32	years	​	6.00	years
Expected dividend yield		​	—	%	​	—	%
Weighted average grant date fair value	​	$	2.34	​	$	7.49	​	​

​

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. In April 2024, the compensation committee of the Board approved RSU grants as inducement awards (“Inducement RSUs”) to certain of the Company’s employees who joined the Company in connection with the Merger. The inducement RSUs vest 25% on each of the first four anniversaries of the date of grant. The Inducement RSUs were granted outside of the Company’s incentive plans in accordance with Nasdaq Listing Rule 5635(c)(4). During the nine months ended September 30, 2025, the Company granted 9,603 RSUs with a weighted average grant date fair value of $7.81 per RSU.

A summary of RSU activity for the nine months ended September 30, 2025 is as follows:

​

​	​	​	​	​
​	​	Number of Units	​	Weighted average grant date fair value
Outstanding and unvested December 31, 2024	​	22,421	​	$ 25.12
Granted	​	9,603	​	$ 7.81
Vested	​	(6,509)	​	$ 25.44
Outstanding and unvested September 30, 2025	​	25,515	​	$ 18.53

​

At September 30, 2025, the unrecognized compensation cost related to unvested service-based RSUs was $382,000, which will be recognized over the remaining service period of 2.35 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 2025 or 2024.

​

10. Segment Information

​

The Company has one operating segment. The Company’s CODM is the interim chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All of the Company’s long-lived assets are held in the United States.

​

The accounting policies of its segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for its segment based on net loss, which is reported on the unaudited condensed consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the balance sheet as total assets. The CODM uses cash forecast models in deciding how to invest into the segment. The CODM analyzes the Company’s net income (loss) and monitors budget versus actual results to assess the performance of the Company.

​

The table below summarizes the significant expense categories, included within the unaudited condensed consolidated statements of operations, regularly reviewed by the CODM for the three and nine months ended September 30, 2025, and 2024:

​

​	​	​	​	​	​	​	​	​	​	​	​
​	Three Months Ended September 30,					​	Nine Months Ended September 30,
​	2025			2024			2025			2024
Revenue	$	—	​	$	57,000	​	$	2,790,000	​	$	170,000
Less:	​	​	​	​	​	​	​	​	​	​	​
Acquired in-process research and development		—	​	​	—	​		—	​	​	117,464,000
Research and development expenses:	​	​	​	​	​	​	​	​	​	​	​
Preclinical and clinical development	​	1,669,000	​	​	849,000	​	​	4,194,000	​	​	2,182,000
Personnel related	​	489,000	​	​	521,000	​	​	1,379,000	​	​	2,500,000
Other research and development (a)	​	153,000	​	​	3,743,000	​	​	1,535,000	​	​	6,307,000
Total research and development expenses		2,311,000	​		5,113,000	​		7,108,000	​		10,989,000
General and administrative expenses:	​	​	​	​	​	​	​	​	​	​	​
Professional and consulting fees	​	698,000	​	​	1,703,000	​	​	2,524,000	​	​	3,786,000
Personnel related	​	547,000	​	​	805,000	​	​	1,963,000	​	​	2,697,000
Other general and administrative (b)	​	499,000	​	​	972,000	​	​	1,702,000	​	​	2,330,000
Total general and administrative	​	1,744,000	​	​	3,480,000	​	​	6,189,000	​	​	8,813,000
Change in fair value of warrant liability	​	3,000	​	​	—	​	​	(26,656,000)	​	​	—
Other income, net		(96,000)	​		(61,000)	​		(464,000)	​		(495,000)
Net (loss) income	$	(3,962,000)	​	$	(8,475,000)	​	$	16,613,000	​	$	(136,601,000)
​	​	​	​	​	​	​	​	​	​	​	​

(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.

​

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Table of Contents

11. 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. As no sales had been generated through September 30, 2025, under the licensed patents, the Company has not incurred any royalty expenses related to this agreement. In addition, the Company is required to pay Temple a percentage of any sublicensing fees received by the Company.

Research and development arrangements with related parties

Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with ChemDiv, Inc. (“ChemDiv”). Pursuant to the Master Research and Development Agreement, ChemDiv provided services related to preclinical drug discovery to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. Dr. Nikolay Savchuk, COO of the Company and a director on the Board, is a stockholder of ChemDiv and a member of its board of directors. During the three and nine months ended September 30, 2025, $125,000 and $2,425,000, respectively, was expensed as research and development (“R&D”) cost in the Company’s unaudited condensed consolidated statements of operations related to ChemDiv’s services. During both the three and nine months ended September 30, 2024, $450,000 was expensed as R&D cost in the Company’s condensed statements of operations related to ChemDiv services. As of September 30, 2025 and December 31, 2024, the Company owed ChemDiv $63,000 and $10,000, respectively, which was included in accounts payable in the Company’s consolidated balance sheets.

​

Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with Viriom. Pursuant to the Master Research and Development Agreement, Viriom provided services related to virology to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. Nikolay Savchuk, COO of the Company, serves as President of Viriom and as a member of its board of directors. Dr. Savchuk has investment control of Viriom and indirectly holds a significant number of its shares of common stock through a limited liability company of which Dr. Savchuk is the managing member and equity holder. Dr. Robert R. Redfield, M.D., the Company’s Chief Medical Officer, serves as a strategic advisor and member of Viriom’s board of directors. Additionally, Dr. C. David Pauza Ph.D., the Company’s Chief Science Officer, served as the Chief Science Officer of Viriom until April 1, 2024, after which time he resigned from any position with Viriom; and Iain Dukes, Executive Chairman of the Company, previously served as CEO of Viriom and as a member of its board of directors. During the three and nine months ended September 30, 2025, $2,594,000 and $2,840,000, respectively, was expensed as R&D cost in the Company’s unaudited condensed consolidated statements of operations related to Viriom’s services. As of September 30, 2025, the Company included $259,000 in accounts payable related to Viriom in the unaudited condensed consolidated balance sheets. As of December 31, 2024, the Company included $113,000 and $15,000 in accounts payable and accrued expenses, respectively, related to Viriom in the consolidated balance sheets. In addition, on September 9, 2025, the Company and Viriom entered into the Purchase Agreement, pursuant to which the Company purchased certain assets from Viriom in exchange for $2,350,000 cash (Note 3).

​

Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with Expert Systems, Inc. (“Expert”). Pursuant to the Master Research and Development Agreement, Expert provided drug development and consulting services to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. An immediate family member of Dr. Savchuk had a significant ownership interest in Expert. Effective April 1, 2025, Dr. Savchuk’s family member divested his ownership interests in Expert Systems and Expert Systems is no longer a related party. During the three and nine months ended September 30, 2025 and prior to termination of the related party relationship with Expert Systems, zero and $72,000, respectively were expensed as research and development costs in the unaudited condensed consolidated statements of operations related to Expert Systems services. As of December 31, 2024, $77,000 and $72,000 was included in accounts payable and accrued expenses, respectively, in the Company’s consolidated balance sheets.

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Table of Contents

​

License Agreement with related party

​

In addition, prior to consummation of the Merger, Trawsfynydd entered into a License Agreement (the “Viriom License Agreement”) with Viriom, pursuant to which Trawsfynydd obtained an exclusive, royalty-free, sublicensable, world-wide license to certain Viriom patents, applications, and technical information (collectively, the “Viriom Licensed IP”) to make, have made, use, sell, offer for sale and import several classes of novel compounds related to the treatment and prevention of viral diseases, specifically for use of the Viriom Licensed IP in the development of treatment and methods to prevent viral disease in Canada, China, the European Union, Hong Kong, Japan, the United States and all areas covered by PCT applications for the Viriom Licensed IP. No annual license fees, royalties, or milestone payments are required. Additionally, pursuant to the Viriom License Agreement, Trawsfynydd obtained the right to control prosecution, defense of infringement and enforcement. As a result of the Merger, the rights and obligations of Trawsfynydd under the Viriom License Agreement were transferred to the Company (through its subsidiaries).      

​

Unless terminated earlier pursuant to the agreement, the Viriom License Agreement shall remain in force and effect for the life of the last-to-expire patent included in the Viriom Licensed IP or last-to-be abandoned patent application licensed under the agreement, whichever is later. The Viriom License Agreement can be terminated by either party due to the material breach of either party (subject to a cure period).

​

25

Table of Contents

​

​

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, 2024 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, 2024, filed with the SEC on March 31, 2025 (“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

26

Table of Contents

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 September 30, 2025, we had cash and cash equivalents of $6.4 million and an accumulated deficit of $632.5 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. Following the closing of the merger in which we acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024 (the “Merger”), we have four clinical programs:

​

● Tivoxavir marboxil, which we acquired as part of 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 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.

​

● 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 COVID19. The main 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.

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​

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 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. 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 patients who are ineligible for treatment with PAXLOVID^®. Our expectation is to report the results of both Phase 2 studies by year-end 2025.

​

● 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 currently under review.

​

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 and data analysis is ongoing.

Narazaciclib is also being developed in greater China, under a 2017 license agreement between our company and HanX. The development in greater China is entirely sponsored by HanX. The compound is being studied in China in a clinical trial of patients with Grade III and IV glioma.

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​

Our objective for narazaciclib is to establish additional partnerships for further development of the compound.

​

● Rigosertib is our second asset in oncology. Rigosertib was recently studied in two investigator-initiated trials in patients with advanced/metastatic squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa (“RDEB-SCC”). A total of five patients were enrolled in the trials for this ultra rare condition. Following treatment, there were two complete cutaneous responses in four evaluable patients out of the five total patients with SCC in the setting of RDEB that were treated with rigosertib. The third patient had significant tumor shrinkage of the primary lesion, facilitating a successful amputation. Patient four demonstrated some initial tumor shrinkage and stayed on treatment for six cycles before being withdrawn due to logistical complications prior to the next scheduled tumor assessment. One patient was not evaluable. This positive clinical activity has attracted attention within the RDEB community of treating physicians. The data presented here are preliminary and may be subject to change. On June 3, 2025, we announced the publication of key clinical efficacy data for rigosertib in patients with RDEB-SCC, which indicated an overall response rate of 80%, with complete responses in 50% of evaluable patients. Our objective for this program is to establish partnerships for the development of rigosertib in this indication.

​

​

Recent Developments

​

Asset Acquisition

​

On September 9, 2025, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Viriom, Inc. (“Viriom”), a related party, pursuant to which we purchased certain assets (the “Purchased Assets”) from Viriom in exchange for $2,350,000 in cash. The Purchased Assets include certain intellectual property and other assets related to a pyrrolidine antiviral compound (the “Compound”), Viriom’s program pipeline related thereto (the “Program”) and any pharmaceutical product containing or comprising the Compound (a “Product”), including without limitation certain patents and patent applications; all other intellectual property controlled by Viriom related to the Program, Compound and Product; a third-party license agreement and rights and obligations related thereto; any and all material regulatory or similar filings, applications or associated correspondence related to the development, manufacture of commercialization of the Compound or product; all materials owned or controlled by Viriom related to the Program, Compound or Product; and certain other related assets. We also incurred legal costs in consummating the Purchase Agreement of $235,000 to the acquired patent. See Note 3, Asset Acquisition, to our unaudited condensed consolidated financial statements included in Part I of this Quarterly Report for more information regarding the Purchase Agreement.

​

At the Market Offering Agreement

​

On March 10, 2025, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common stock, having aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement, 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. The Company is not obligated to make any sales of common stock under the ATM Agreement and no assurance can be given that the Company will sell any shares under the ATM Agreement, or, if it does, as to the price or amount of shares that the Company will sell, or the dates on which any such sales will take place. The ATM Agreement may be terminated by the Company at any time with five business days’ notice to Citizens, by Citizens at their discretion, or as otherwise permitted in the ATM Agreement.

​

The shares of common stock sold to Citizens under the ATM Agreement will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-273081), filed with the SEC on June 30, 2023, and declared effective by the Commission on July 11, 2023, including the base prospectus contained therein, as supplemented by those prospectus supplements dated March 10, 2025 and April 7, 2025 (the “Prospectus Supplements”) and filed with the SEC pursuant to Rule 424(b) under the Securities Act, or

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subsequently filed prospectus supplements as applicable. In accordance with the terms of the ATM Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $7.4 million (which is in addition to the gross proceeds of approximately $0.1 million from sales completed prior to April 7, 2025), from time to time, to or through Citizens, which was the Company’s current “baby shelf” limitation under General Instruction I.B.6. of Form S-3 as of the date of filing the Prospectus Supplement. In the quarter ended September 30, 2025, the Company sold and issued an aggregate of 62,003 shares of its common stock under the ATM Agreement for net proceeds of $0.1 million.

The Company will pay Citizens a commission at a fixed rate of 3.0% of the gross proceeds of each sale of shares of common stock sold through or to Citizens under the ATM Agreement and will reimburse Citizens for the fees and disbursements of its legal counsel incurred in connection with entering into the transactions contemplated by the ATM Agreement in an amount not to exceed $50,000 in the aggregate, in addition to up to $5,000 per “Representation Date” (as defined in the ATM Agreement) in connection with ongoing diligence arising from the transactions contemplated by the ATM Agreement.

​

The Company made certain customary representations, warranties and covenants in the ATM Agreement concerning the Company and its subsidiaries, the registration statement and base prospectus contained therein, prospectus supplement and other documents and filings relating to the offering of the shares under the ATM Agreement. In addition, the Company has also provided Citizens with customary indemnification rights.

​

Warrants

​

On February 17, 2025, the Company held a special meeting of its stockholders, at which, the Company’s stockholders approved (i) in accordance with Nasdaq Listing Rule 5635(d), the issuance of more than 19.99% of the outstanding shares of the Company’s common stock upon exercise of the pre-funded warrants and Series A Warrants sold and issued to investors in a private placement on December 31, 2024 (the “December 2024 Offering”), and (ii) in accordance with Nasdaq Listing Rule 5635(c), the issuance of shares of the Company’s common stock upon exercise of the pre-funded warrants and Series A Warrants sold and issued to certain insiders in the December 2024 Offering. As a result of such approvals, the pre-funded warrants became immediately exercisable and limitations on the exercisability of the Series A Warrants under applicable Nasdaq rules were lifted. Subsequent to such shareholder meeting, and through September 30, 2025, certain purchasers have exercised their pre-funded warrants for an aggregate of 1,582,559 shares of the Company’s common stock.  

​

On February 18, 2025, the Company and certain of the purchasers of units in the December 2024 Offering entered into amendments to the Series A Warrants issued to such purchasers in the offering (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.

​

On March 27, 2025,  the Company and the holders of all outstanding pre-funded warrants issued in the December 2024 Offering entered into amendments to the pre-funded warrants issued to such purchasers in the offering (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.  

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​

On October 8, 2025 the Company issued 652,526 shares of common stock to a holder of pre-funded warrants upon exercise of such pre-funded warrants by the holder.

​

Changes in Management and the Board of Directors

​

Effective as of the close of business on March 31, 2025, Werner Cautreels retired and resigned from his role as Chief Executive Officer of the Company and Iain Dukes, who was serving as Executive Chairman as of such date, was appointed as Interim Chief Executive Officer and his director role changed from Executive Chairman to Chairman of the Board. Dr. Cautreels continues to serve as a director on the Company’s Board of Directors (the “Board”) and now provides certain consulting services to the Company.

​

On April 15, 2025, Dr. Dukes stepped down as Chairman of the Board, and the Board appointed Jack Stover, an independent director who has served as a member of the Board since 2016, as Chairman. Dr. Dukes continues to serve as a member of the Board. On October 1, 2025, the Board eliminated the “interim” notation in Dr. Iain Dukes’ title, who now holds the title of Chief Executive Officer.

​

On July 2, 2025, Nora Brennan notified the Company of her decision to resign from her role as Interim Chief Financial Officer of the Company, effective as of July 5, 2025, which was the final day of the interim period contemplated by that offer letter entered into by and between the Company and Ms. Brennan on February 5, 2025. Effective as of July 5, 2025, Charles Parker was appointed to serve as the Company’s Interim Chief Financial Officer. On October 1, 2025, the Board eliminated the “interim” notation in Mr. Parker’s title, who now holds the title of Chief Financial Officer. Mr. Parker has been retained to provide such services as a non-employee consultant of the Company.

​

On October 1, 2025, the Board appointed John Leaman, MD as an independent director of the Company, with a term expiring at the Company’s 2025 annual meeting of stockholders. Dr. Leaman was also appointed as a member of the Audit Committee of the Board.

​

Reverse Stock Split

​

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

​

Nasdaq Compliance

​

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

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Results of Operations

​

Comparison of the Three Months Ended September 30, 2025 and 2024

​

​	​	​	​	​	​	​	​	​	​
​	​	Three Months Ended September 30,					​	​	​
​		2025			2024			Change
Revenue	​	$	—	​	$	57,000	​	$	(57,000)
Operating expenses:		​			​			​
In-process research and development		​	—		​	—		​	—
Research and development		​	2,311,000		​	5,113,000		​	2,802,000
General and administrative		​	1,744,000		​	3,480,000		​	1,736,000
Total operating expenses		​	4,055,000		​	8,593,000		​	4,538,000
Loss from operations		​	(4,055,000)		​	(8,536,000)		​	4,481,000
Change in fair value of warrant liability		​	(3,000)		​	—		​	(3,000)
Other income, net		​	96,000		​	61,000		​	35,000
Net loss	​	$	(3,962,000)	​	$	(8,475,000)	​	$	4,513,000

​

Revenues

​

Revenues during the three months ended September 30, 2024 were $0.1 million, related to the Company’s license agreement with Symbio Pharmaceuticals Limited (“Symbio”). Effective April 17, 2025, the Company and Symbio mutually terminated the license agreement originally entered into by and between the parties in 2011. As a result, on April 17, 2025, the Company recognized $2.7 million of previously deferred revenue. No further revenue will be recognized going forward in connection with this agreement.

​

Research and development expenses

​

The details of our research and development expenses are:

​

​	​	​	​	​	​	​
​	​	Three Months Ended September 30,
​		2025			2024
Virology	​	$	1,637,000	​	$	3,295,000
Oncology	​		168,000	​		1,285,000
Personnel related	​		489,000	​		521,000
Stock based compensation	​		17,000	​		12,000
​	​	$	2,311,000	​	$	5,113,000

​

Research and development expenses decreased by $2.8 million, or (55)%, to $2.3 million for the three months ended September 30, 2025 from $5.1 million for the three months ended September 30, 2024. This decrease was primarily related to a $1.7 million decrease in virology expenses as we deferred the initiation of the Phase 2 study in tivoxavir marboxil and shifted emphasis to preparation for patient enrollment in the Phase 2 study for TRX01 in which dosing was initiated in October 2025 and a $1.1 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets.

​

General and administrative expenses

​

​	​	​	​	​	​	​
​	​	Three Months Ended September 30,
​		2025			2024
Professional and consulting fees	​	$	698,000	​	$	1,703,000
Stock based compensation	​	​	118,000	​	​	325,000
Personnel related	​		547,000	​		805,000
Public company costs	​		234,000	​		309,000
Insurance and other	​	​	147,000	​	​	338,000
​	​	$	1,744,000	​	$	3,480,000

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​

General and administrative expenses decreased by $1.7 million, or (50)%, to $1.7 million for the three months ended September 30, 2025, from $3.5 million for the three months ended September 30, 2024. This decrease was primarily attributable to a $1.0 million decrease in professional and consulting fees, a $0.3 million decrease in personnel related expenses, a $0.2 million decrease in stock based compensation expenses, a $0.2 million decrease in insurance and other costs and a $0.1 million decrease in public company costs.

Change in fair value of warrant liability

​

The change in fair value of warrant liability of $3.0 thousand during the three months ended September 30, 2025 represents the remeasurement of the Series A Warrant liability as of September 30, 2025.

​

Comparison of the Nine Months Ended September 30, 2025 and 2024

​

​	​	​	​	​	​	​	​	​	​	​
​	​	Nine Months Ended September 30,					​	​	​	​
​		2025			2024			Change		​
Revenue	​	$	2,790,000	​	$	170,000	​	$	2,620,000	​
Operating expenses:		​			​			​		​
Acquired in-process research and development		​	—		​	117,464,000		​	117,464,000	​
Research and development		​	7,108,000		​	10,989,000		​	3,881,000	​
General and administrative		​	6,189,000		​	8,813,000		​	2,624,000	​
Total operating expenses		​	13,297,000		​	137,266,000		​	123,969,000
Loss from operations		​	(10,507,000)		​	(137,096,000)		​	126,589,000
Change in fair value of warrant liability		​	26,656,000		​	—		​	26,656,000
Other income, net		​	464,000		​	495,000		​	(31,000)
Net income (loss)	​	$	16,613,000	​	$	(136,601,000)	​	$	153,214,000	​

​

Revenues

​

Revenues were $2.8 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively, related to the Company’s license agreement with Symbio. The increase of $2.6 million is primarily due to the immediate revenue recognition of the remaining deferred revenue of $2.7 million as a result of terminating the license agreement with Symbio on April 17, 2025. No further revenue will be recognized going forward in connection with this agreement.

​

Acquired in-process research and development

​

In connection with the acquisition of Trawsfynydd in the Merger, during the nine months ended September 30, 2024, the Company recognized a non-cash in-process research and development expense of $117.5 million related to the acquired virology programs that had no alternative future use at the time of acquisition, which required immediate expense recognition.

​

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Research and development expenses

​

The details of our research and development expenses are:

​

​	​	​	​	​	​	​
​	​	Nine Months Ended September 30,
​		2025			2024
Virology	​	​	4,830,000	​	​	4,483,000
Oncology	​	​	849,000	​	​	3,842,000
Personnel related	​		1,379,000	​		2,500,000
Stock based compensation	​		50,000	​		164,000
​	​	$	7,108,000	​	$	10,989,000

​

Research and development expenses decreased by $3.9 million, or (35)%, to $7.1 million for the nine months ended September 30, 2025 from $11.0 million for the nine months ended September 30, 2024. This decrease was primarily related to a $3.0 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets, a $1.1 million decrease in personnel expenses and a $0.1 million decrease in stock based compensation expenses, partially offset by a $0.3 million increase in virology expenses due to the focus on initiating Phase 2 studies for both tivoxavir marboxil and TRX01 prior to our strategic shift announced in the third quarter of 2025.

​

General and administrative expenses

​

​	​	​	​	​	​	​
​	​	Nine Months Ended September 30,
​		2025			2024
Professional and consulting fees	​	$	2,524,000	​	$	3,786,000
Stock based compensation	​	​	351,000	​	​	891,000
Personnel related	​		1,963,000	​		2,697,000
Public company costs	​		817,000	​		778,000
Insurance and other	​	​	534,000	​	​	661,000
​	​	$	6,189,000	​	$	8,813,000

​

General and administrative expenses decreased by $2.6 million, or (30)%, to $6.2 million for the nine months ended September 30, 2025 from $8.8 million for the nine months ended September 30, 2024. This decrease was primarily attributable to a $1.3 million decrease in professional and consulting fees, a $0.7 million decrease in personnel related expenses, a $0.5 million decrease in stock based compensation expenses, and a $0.1 million decrease in insurance and other expenses.

​

Change in fair value of warrant liability

​

Change in fair value of warrant liability of $26.7 million during the nine months ended September 30, 2025 represents the remeasurement of the warrant liability upon amendment of the pre-funded and Series A Warrants issued in the December 2024 Offering, the exercise of pre-funded warrants, and the remaining Series A Warrants as of September 30, 2025.

​

Liquidity and Capital Resources

​

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. As of September 30, 2025, the Company had an accumulated deficit of $632.5 million, working capital of $1.7 million, and cash and cash equivalents of $6.4 million. As of September 30, 2025, the Company had sold and issued an aggregate of 1,627,050 shares of its common stock under the ATM Agreement for net proceeds of $3.3 million, 62,003 of which shares were sold by the Company in the three months ended September 30, 2025 for net proceeds of $0.1 million. 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 date that the financial statements included in this Quarterly Report are issued. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern. Due to the inherent uncertainty involved in making estimates and the risks associated

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with the research, development, and commercialization of biopharmaceutical products, we may have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us.

​

We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue to execute our strategy. To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to explore various dilutive and non-dilutive sources of funding, including debt and equity financings (including pursuant to the ATM Agreement), strategic alliances, business development and/or combinations, and other sources. The future success of the Company is dependent upon our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such funding in sufficient 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. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that the financial statements included in this Quarterly Report are issued.

​

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 nine months ended September 30, 2025 and 2024:

​

​	​	​	​	​	​	​
​	​	Nine Months Ended September 30,
​		2025			2024
Net cash (used in) provided by:		​			​
Operating activities	​	$	(15,427,000)	​	$	(25,752,000)
Investing activities	​		(2,585,000)	​		(3,648,000)
Financing activities	​		3,046,000	​		13,999,000
Effect of foreign currency translation	​		48,000	​		(10,000)
Net decrease in cash and cash equivalents	​	$	(14,918,000)	​	$	(15,411,000)

​

Operating Activities

Net cash used in operating activities was $15.4 million for the nine months ended September 30, 2025, which consisted of non-cash charges of $26.2 million primarily attributable to the change in fair value of warrant liability of $26.7 million and a $5.8 million change in operating assets and liabilities, partially offset by net income of $16.6 million. Significant changes in operating assets and liabilities included a net decrease in accounts payable, accrued expenses, and deferred revenue of $7.4 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 $0.8 million.

Net cash used in operating activities was $25.8 million for the nine months ended September 30, 2024 and consisted primarily of a net loss of $136.6 million and a $7.7 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 $5.8 million due to timing of invoices and payments to our vendors. These operating uses of cash were offset by $118.5 million in non-cash charges primarily attributable to the immediate expensing of in-process research and development acquired in connection with the acquisition of Trawsfynydd in the Merger of $117.5 million and $1.1 million related to stock-based compensation expense.

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Investing Activities

Net cash used in investing activities was $2.6 million for the nine months ended September 30, 2025 and was attributable to the purchase of intangible assets. Net cash used in investing activities was $3.6 million for the nine months ended September 30, 2024, and primarily related to the transaction costs paid in cash of $3.6 million in connection with the acquisition of Trawsfynydd in the Merger.

​

Financing Activities

Net cash provided by financing activities was $3.0 million for the nine months ended September 30, 2025, and was attributable to the proceeds received from the sale of shares of our common stock under the ATM and proceeds from exercised warrants, partially offset by the payment of offering costs. Net cash provided by financing activities was $14.0 million for the nine months ended September 30, 2024 and was attributable to the net proceeds received from the private placement of our common stock.

​

Material Cash Requirements

We have not achieved profitability since our inception and we expect to continue to incur operating losses for the foreseeable future. Our research and development expenditures are expected to increase as our TRX01 study progresses. 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 date that the financial statements included in this Quarterly Report 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 new drug application 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 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.

Uncertainty in the business, political and macroeconomic environments in which we operate present significant risks to our business and could materially impact our expected cash requirements and our ability to raise additional financing when needed. We are subject to continuing risks and uncertainties, including increasing financial market volatility and uncertainty, inflation, interest rate fluctuations, changing tariff policies and trade restrictions, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system, cybersecurity events, the impact of war or military conflicts, including regional conflicts around the world, and public health pandemics. We closely monitor the impact of these factors on all aspects of our business, including the impacts on our clinical trial patients, employees, partner, suppliers, and vendors.

​

The ultimate impact of global and domestic economic conditions on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside

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of our control and could exist for an extended period of time. As a result, we are subject to continuing risks and uncertainties and continue to closely monitor the impact of the current conditions on our business.

​

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

​

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, revenue recognition, deferred revenue, stock-based compensation, acquired in-process research and development and the contingent value rights. We base our estimates on historical experience, 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 September 30, 2025, 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

Managements’ 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 September 30, 2025. 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 September 30, 2025, and due to the identification of material weaknesses in our internal controls over financial reporting as of December 31, 2024, as discussed in additional detail in our Annual Report, which had not been remediated as of September 30, 2025, our principal executive and principal financial officers concluded that, as of such date, our disclosure controls and procedures were not 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

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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

Our management, with the participation of our principal executive and principal financial officers, evaluated any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our most recently completed fiscal quarter. Based on that evaluation, our principal executive and principal financial officers concluded that, other than those remediation efforts discussed in “Management’s Plan for Remediation,” no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

​

Management's Plan for Remediation

​

As previously disclosed in Item 9A of our Annual Report, management identified material weaknesses in our internal control over financial reporting due to the fact that our controls were not effectively updated and implemented to reflect the changes in processes and staffing as a result of the Merger. This is the result of not having a sufficient risk assessment process in place post-Merger to identify and analyze risks of misstatement due to fraud and/or error. Additionally, management determined that there was an inadequate segregation of duties over the preparation, review and posting of manual journal entries.

As of September 30, 2025, we have made progress against the remediation plan that we previously disclosed under Item 9A. Controls and Procedures in our Annual Report. In furtherance of such remediation efforts, we have engaged various consultants with finance and accounting experience; taken steps to educate our employees and consultants with respect to their respective responsibilities under our policies and procedures to ensure that such policies and procedures are properly implemented and followed; engaged with the Audit Committee, our independent accounting firm and our SOX advisors to identify breakdowns in our processes and procedures and risks associated therewith, as well as to identify areas for improvement. While we believe that our remediation plan, once fully implemented, will be sufficient to remediate the material weaknesses prior to December 31, 2025, such a conclusion cannot be reached until applicable controls have been designed, implemented and have operated for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. As of September 30, 2025, this evaluation remains ongoing.

​

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PART II — OTHER INFORMATION

Item 1. Legal Proceedings

For a description of our material pending legal proceedings, please see Note 6, Commitments and Contingencies, to our unaudited condensed consolidated financial statements included in Part I of this Quarterly Report. We may, in the 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.

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Except as set forth below, there have not been any material changes to the risk factors disclosed in the Annual Report.

​

A prolonged U.S. federal government shutdown could materially and adversely affect our business and operations.

Any disruption in the operations of the U.S. government, including as a result of the recent prolonged shutdown or future temporary or prolonged shutdowns resulting from the failure of Congress to enact appropriations bills or raise the federal debt ceiling, could materially and adversely affect our business, operations and financial condition. Recently, beginning on October 1, 2025, the U.S. federal government shut down, during which time certain regulatory agencies, such as the FDA and the SEC, furloughed critical employees and stopped critical activities.  Additionally, on October 10, 2025, the U.S. government implemented substantial layoffs and workforce reductions in connection with the federal government shutdown, which resulted in the suspension or delay of various government-funded programs. While we continue to monitor developments, there is no assurance that affected government employees or contractors will be reinstated and that all government-funded programs will resume as normal. Furthermore, the federal government shutdown has resulted, and may continue for a prolonged period of time to result, in reduced availability of government services, and suspension or delay of activities by key agencies that regulate, fund, or interact with our business, including the SEC, the FDA, the Department of Health and Human Services, and the U.S. Patent and Trademark Office. As a result, the review and approval of our filings, applications, and submissions could be delayed, and we may be unable to access or rely upon certain government data or systems. In particular, it may lead to disruptions and delays in FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development program or pending applications.

​

Additionally, a prolonged or future shutdown of the U.S. federal government could materially impact the operations of the SEC. For example, the SEC announced that during the recent U.S. federal government shutdown, it would not review or declare registration statements effective. In the event of an extended shutdown, the SEC may operate with limited staff or suspend certain functions altogether, which could delay the review or effectiveness of our filings, including registration statements or other financing-related disclosures. Such delays could adversely affect our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue to fund our operations.

​

Government shutdowns, if prolonged, can significantly impact the ability of government agencies upon which rely, such as the FDA and SEC, to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Even the threat of a government shutdown or prolonged budget negotiation uncertainty may adversely affect the broader U.S. economy, investor confidence, and capital markets. Such conditions could negatively impact our access to financing, timing of capital-raising transactions, and the liquidity or trading volume of our securities. Accordingly, the current or future federal government shutdowns, or uncertainty regarding the continuity of government operations, could have a material adverse effect on our business, results of operations, and stock price.

Federal budget and debt-ceiling disputes may adversely affect capital markets and our financing activities.

Moreover, the uncertainty surrounding government funding debates and debt-ceiling negotiations can negatively affect market conditions, investor sentiment, and the liquidity of small-cap and microcap issuers such as ours. If market volatility or trading disruptions were to occur during the current or future government shutdowns, our ability to execute at-the-market offerings or other financing transactions under our effective shelf registration statement or through private equity offerings could be materially impaired.

Accordingly, any federal government shutdown or protracted budget impasse could materially and adversely affect our regulatory compliance, financing options and capabilities, and overall financial condition.

​

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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 September 30, 2025, 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 September 30, 2025.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

During the three months ended September 30, 2025, none of our directors or officers adopted, modified, or terminated 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
10.1	+	Asset Purchase Agreement, dated September 9, 2025.
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

+  Certain annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request.

† 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: November 13, 2025

/s/ Iain Dukes, D. Phil

Iain Dukes, D. Phil

Chief Executive Officer

(Principal Executive Officer)

Dated: November 13, 2025

/s/ Charles Parker

Charles Parker

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

​

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44

FAQ

What were TRAW’s Q3 2025 results?

Traws reported a Q3 net loss of $3.96 million on operating expenses of $4.06 million and no revenue.

What is TRAW’s cash position and equity?

Cash and cash equivalents were $6.42 million and stockholders’ equity was $4.55 million as of September 30, 2025.

Did TRAW raise capital during 2025?

Yes. Under an ATM program of up to $50 million, the company issued 1,627,050 shares for $3.27 million net proceeds.

Why did year-to-date results show net income?

Nine‑month net income of $16.61 million was driven by a $26.66 million non‑cash gain from warrant liability changes and revenue recognition from a license termination.

What did TRAW acquire from Viriom?

On September 9, 2025, Traws acquired certain antiviral IP assets for $2.35 million cash, recorded as a patent at $2.57 million net.

Is there a going concern warning for TRAW?

Yes. Management stated “substantial doubt” about the company’s ability to continue as a going concern based on current cash projections.

How did warrant liabilities change?

Warrant liabilities decreased from $42.49 million at year‑end 2024 to $11,000 at September 30, 2025 due to reclassification and fair value changes.