Traws Pharma, Inc.

Previous wording

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

Current wording

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

Previous wording

As of March 31, 2025, we had cash and cash equivalents of $15.9 million and an accumulated deficit of $627.7 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 report to support our operations for at least the 12 months following the date that these financial statements are issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.

Current wording

As of June 30, 2025, we had cash and cash equivalents of $13.1 million and an accumulated deficit of $628.6 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 report to support our operations for at least the 12 months following the date that these financial statements are issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.

Previous wording

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. To date, 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.

Current wording

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. 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.

Previous wording

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 adverse events reported up to the highest dose, and none were determined to be related to study drug. Topline data from the study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days.

Current wording

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. The proposed study has been submitted for HREC review and 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.

Previous wording

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 supplement 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 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 $7,427,749 (which is in addition to the gross proceeds of approximately $122,210 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.

Current wording

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 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 June 30, 2025, the Company sold and issued an aggregate of 1,522,947 shares of its common stock under the ATM Agreement for net proceeds of $3.0 million.

Previous wording

On February 17, 2025, the Company held a special meeting of its stockholders, at which, the Company’s stockholder 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, certain purchasers exercised their pre-funded warrants for an aggregate of 1,382,559 shares of the Company’s common stock.

Current wording

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 June 30, 2025, certain purchasers have exercised their pre-funded warrants for an aggregate of 1,582,559 shares of the Company’s common stock.

Previous wording

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-

Current wording

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.

Previous wording

Effective as of 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 Board and now provides certain consulting services to the Company.

Current wording

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 Board and now provides certain consulting services to the Company.

Previous wording

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 on Form 10-Q, including the financial statements and footnotes thereto included herein, have been retroactively adjusted to give effect to the Reverse Stock Split.

Current wording

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.

Previous wording

Research and development expenses increased by $0.6 million, or 31%, to $2.5 million for the three months ended March 31, 2025 from $1.9 million for the three months ended March 31, 2024. This increase was primarily related to our prioritization of tivoxavir marboxil and TRX01, resulting in a $1.7 million increase in expenses related to our virology programs and a decrease in oncology expenses of $0.8 million.

Current wording

Research and development expenses decreased by $1.7 million, or (42)%, to $2.3 million for the three months ended June 30, 2025 from $4.0 million for the three months ended June 30, 2024. This decrease was primarily related to a $1.0 million decrease in oncology expenses and a decrease in personnel expenses of $0.9 million.

Previous wording

General and administrative expenses decreased by $0.6 million, or 18%, to $2.8 million for the three months ended March 31, 2025 from $3.4 million for the three months ended March 31, 2024. This decrease was primarily attributable to a $0.9 million decrease in consulting fees, partially offset by a $0.1 million increase in personnel related expenses attributable to severance expenses of $0.4 million.

Current wording

General and administrative expenses decreased by $0.3 million, or (14)%, to $1.7 million for the three months ended June 30, 2025, from $2.0 million for the three months ended June 30, 2024. This decrease was primarily attributable to a $0.6 million decrease in personnel related expenses and a $0.3 million decrease in stock based compensation expenses, partially offset by a $0.6 million increase in professional and consulting fees.

Previous wording

Change in fair value of warrant liability of $26.5 million during the three months ended March 31, 2025 represents the remeasurement of the warrant liability upon amendment of the pre-funded and Series A Warrants issued in the December 2024 Offering, the exercise of pre-funded warrants, and the remaining Series A Warrants as of March 31, 2025.

Current wording

Change in fair value of warrant liability of $26.7 million during the six months ended June 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 June 30, 2025.

Previous wording

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 March 31, 2025, the Company had an accumulated deficit of $627.7 million, working capital of $0.6 million, and cash and cash equivalents of $15.9 million. During the three months ended March 31, 2025, the Company sold and issued 42,100 shares of its common stock under the ATM Agreement for net proceeds of $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 these financial statements 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 with the research, development, and commercialization of biotechnology 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.

Current wording

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 June 30, 2025, the Company had an accumulated deficit of $628.6 million, working capital of $8.0 million, and cash and cash equivalents of $13.1 million. As of June 30, 2025, the Company had sold and issued an aggregate of 1,565,047 shares of its common stock under the ATM Agreement for net proceeds of $3.2 million, 1,522,947 of which shares were sold by the Company in the three months ended June 30, 2025 for net proceeds of $3.0 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 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.

Previous wording

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 these financial statements are issued.

Current wording

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.

Previous wording

The following table summarizes the Company’s cash flows for the three months ended March 31, 2025 and 2024:

Current wording

The following table summarizes the Company’s cash flows for the six months ended June 30, 2025 and 2024:

Previous wording

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

Current wording

Net cash used in operating activities was $11.4 million for the six months ended June 30, 2025, which consisted of non-cash charges of $26.4 million primarily attributable to the change in fair value of warrant liability of $26.7 million and a $5.6 million change in operating assets and liabilities, partially offset by net income of $20.6 million. Significant changes in operating assets and liabilities included a net decrease in accounts payable, accrued expenses, and deferred revenue of $6.9 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 $1.3 million.

Previous wording

Net cash used in operating activities was $4.4 million for the three months ended March 31, 2024 and consisted primarily of a net loss of $5.0 million, including $0.3 million of noncash stock-based compensation and depreciation expense. Changes in operating assets and liabilities resulted in a net increase in cash of $0.2 million. Significant changes in operating assets and liabilities included an increase in accounts payable of $0.9 million and a decrease in accrued liabilities of $0.8 million due to timing of invoices and payments to our vendors, a decrease in prepaid expenses and other current assets of $0.1 million, and a decrease in deferred revenue of $0.1 million due to recognition of the unamortized portion of the upfront payment under our collaboration agreement with SymBio.

Current wording

Net cash used in operating activities was $14.3 million for the six months ended June 30, 2024 and consisted primarily of a net loss of $128.1 million and $4.3 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 $4.3 million due to timing of invoices and payments to our vendors. These operating uses of cash were offset by $118.2 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 of $117.5 million and $0.7 million related to stock-based compensation expense.

Previous wording

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 these 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 March 31, 2025, there have been no significant changes in our critical accounting policies and estimates as discussed in our Annual Report.

Current wording

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 June 30, 2025, there have been no significant changes in our critical accounting policies and estimates as discussed in our Annual Report.