Non-inferiority trial to assess safety and efficacy, including rates of disease rebound and incidence of Long COVID development of ratutrelvir, a ritonavir-free treatment, compared to PAXLOVID® Separate single-arm trial will assess safety and efficacy in PAXLOVID®-ineligible subjects, who represent a significant vulnerable population with few available treatment options Top-line data from both trials expected by year-end 2025 NEWTOWN, Pa., Aug. 18, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ...

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $13.1 million, down from $21.3 million as of December 31, 2024 [26] - Revenue for the quarter ended June 30, 2025, was $2.7 million, a significant increase from $57,000 for the same period in 2024, primarily due to $2.7 million in deferred revenue recognized from a licensing agreement termination [26] - Research and development expenses for the second quarter of 2025 totaled $2.3 million, down from $4 million in the comparable period in 2024, reflecting decreased oncology program expenses [27] - General and administrative expenses decreased to $1.7 million from $2 million in the same period in 2024, mainly due to lower personnel-related expenses [27] - The net loss for the second quarter of 2025 was $900,000, or $0.11 per share, compared to a net loss of $123.1 million, or $20.52 per share, for the same period in 2024 [28] Business Line Data and Key Metrics Changes - The company is advancing its COVID program with a phase two study of Racutrelvir, aimed at newly diagnosed COVID patients, and expects to report results by year-end 2025 [6][7] - The influenza program is in discussions with BARDA regarding the inclusion of Tivoxavir and Marboxyl in the drug stockpiling initiative, indicating potential commercial opportunities [7][8] Market Data and Key Metrics Changes - Pfizer reported $427 million in sales of Paxlovid for the second quarter of 2025, representing a 70% increase compared to the same period in the prior year, highlighting the competitive landscape in antiviral treatments [7] Company Strategy and Development Direction - The company has reprioritized its clinical trial plans to enhance shareholder value, focusing on antiviral candidates for COVID and influenza [6][29] - The strategy includes maximizing opportunities in the short and medium term, particularly through the development of Racutrelvir and Tivoxavir [29] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing public health threat posed by COVID-19 and the need for effective antiviral treatments, particularly as vaccine immunity wanes [10][14] - The company is committed to addressing the long COVID issue, which affects over 15 million people in the U.S., through its investigational therapies [15] - The management expressed concerns about the potential risks of avian influenza and the need for preparedness measures, advocating for the development of new treatments [21][22] Other Important Information - The company is seeking partnerships to advance its legacy oncology assets, particularly rigosertib, which has shown promising efficacy in a rare disease [24] Q&A Session Summary - The Q&A session was not conducted as the call concluded without any questions being taken from participants [32]

[Executive Summary & Business Highlights](index=1&type=section&id=executive_summary_business_highlights) [Company Overview and Strategic Focus](index=1&type=section&id=company_overview_strategic_focus) Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including SARS-CoV-2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM), with a strategic shift towards antivirals as both therapeutic and prophylactic agents - Traws Pharma is a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, including SARS-CoV-2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM)[3](index=3&type=chunk) - Antivirals are emphasized for their dual therapeutic (eliminating viral infections) and prophylactic (preventing viral infections or spreading) benefits, unlike vaccines[3](index=3&type=chunk) [CEO's Strategic Reprioritization](index=1&type=section&id=ceo_strategic_reprioritization) The Interim CEO, Iain D. Dukes, announced a reprioritization of clinical trial plans to enhance short and medium-term shareholder value, focusing on advancing ratutrelvir for COVID-19 (including PAXLOVID-ineligible patients and Long COVID) and engaging BARDA for TXM's inclusion in influenza drug stockpiling - Traws has reprioritized clinical trial plans to reflect potential short and medium-term shareholder value[4](index=4&type=chunk) - For the COVID program, a Phase 2 study of ratutrelvir (ritonavir-free) has been submitted to HREC to evaluate safety and efficacy against PAXLOVID in newly diagnosed COVID patients, and separately, in PAXLOVID-ineligible patients, with results expected by year-end 2025[4](index=4&type=chunk) - For the influenza program, constructive discussions with BARDA are ongoing regarding the inclusion of TXM in the drug stockpiling initiative, which represents the major short-to-medium-term commercial potential[4](index=4&type=chunk) PAXLOVID Sales Performance (Q2 2025) | Metric | Q2 2025 Sales | | :----- | :------------ | | PAXLOVID | $427 million | | YoY Increase | 70% | [CMO & CSO Perspectives on Public Health Needs](index=2&type=section&id=cmo_cso_perspectives_public_health_needs) The CMO and CSO highlighted the ongoing public health challenges posed by COVID and influenza, emphasizing the limitations of current treatments (drug-drug interactions, rebound infections, Long COVID risk), believing Traws' ritonavir-free COVID and once-daily flu candidates can overcome these shortcomings - COVID and influenza continue to mutate and pose critical threats, with close to **one million hospitalizations** and **tens of thousands of deaths** reported in the 2024-2025 virus season[5](index=5&type=chunk) - Current COVID treatments like PAXLOVID are often contraindicated in vulnerable populations due to ritonavir-based drug-drug interactions and can result in rebound infections and long-term viral syndromes[5](index=5&type=chunk) - Traws' ritonavir-free COVID (ratutrelvir) and once-daily flu (TXM) candidates are believed to have the potential to overcome current treatment shortcomings and become the new standard of care[5](index=5&type=chunk) - Ratutrelvir's emerging profile, based on broad activity against resistant strains and good overall tolerability for once-daily dosing, could position it for wide adoption, especially in vulnerable individuals, and potentially reduce rebound and Long COVID risk[5](index=5&type=chunk) [Recent Highlights and Anticipated Milestones](index=3&type=section&id=recent_highlights_anticipated_milestones) [Ratutrelvir (COVID Program)](index=3&type=section&id=ratutrelvir_covid_program) Ratutrelvir is an investigational ritonavir-independent oral Mpro inhibitor for acute COVID infection, with potential to reduce rebound and Long COVID, including in PAXLOVID-ineligible patients; Phase 1 data showed sustained plasma levels and no adverse events, supporting its best-in-class potential, with a Phase 2 non-inferiority study against PAXLOVID planned to start soon in Australia - Ratutrelvir is a ritonavir-independent investigational oral Main protease (Mpro) inhibitor designed for potential once-daily, 10-day dosing for acute COVID infection[6](index=6&type=chunk)[8](index=8&type=chunk) - It is intended for acute COVID infection, with potential to reduce the risk of COVID rebound and Long COVID, including in PAXLOVID-ineligible patients[8](index=8&type=chunk) - The U.S. market opportunity for COVID treatment is estimated to be a **multi-billion dollar market**[8](index=8&type=chunk) - Phase 1 studies showed ratutrelvir maintained plasma drug levels **four times above the EC90** over a 10-day treatment period in healthy volunteers, with no drug-induced metabolism or treatment-related adverse events, suggesting a novel, best-in-class therapy[8](index=8&type=chunk) - Next steps include initiating dosing in a Phase 2 non-inferiority study in Australia comparing ratutrelvir to PAXLOVID in newly diagnosed COVID patients, and a single-arm study for PAXLOVID-ineligible patients[8](index=8&type=chunk) [Tivoxavir Marboxil (Influenza Program)](index=3&type=section&id=tivoxavir_marboxil_influenza_program) Tivoxavir Marboxil (TXM) is a single-dose investigational CAP-dependent endonuclease inhibitor for bird flu and seasonal flu, with a multi-billion dollar U.S. market opportunity, largely driven by stockpiling initiatives; Phase 1 data showed sustained plasma levels and good tolerability, and preclinical studies demonstrated compelling protection against mortality and disease in multiple animal models against H5N1 virus, with discussions with BARDA for stockpiling advancing - TXM is a single-dose, investigational CAP-dependent endonuclease inhibitor for the treatment or prevention of H5N1 bird flu and seasonal flu[6](index=6&type=chunk)[8](index=8&type=chunk) - The U.S. market opportunity is estimated to be a **multi-billion dollar market**, including potential for stockpiling in the short- to medium-term[8](index=8&type=chunk) - Phase 1 data showed TXM maintained plasma blood levels above the EC90 for approximately **three weeks** after a single oral dose with good overall tolerability[8](index=8&type=chunk) - TXM demonstrated compelling protection against mortality and disease in three well-accepted flu models (mice, ferrets, non-human primates) using H5N1 virus, reducing viral burden and increasing survival[8](index=8&type=chunk) - Next steps include advancing discussions with BARDA and other regulatory agencies regarding TXM's inclusion in drug stockpiling initiatives for pandemic preparedness[8](index=8&type=chunk) [Legacy Oncology Programs](index=3&type=section&id=legacy_oncology_programs) Traws' strategic objective for its legacy oncology assets, rigosertib and narazaciclib, is to establish additional partnerships for further development; rigosertib, intended for RDEB SCC, showed a compelling overall response rate of 80% (50% complete responses) in clinical efficacy data published in the British Journal of Dermatology, highlighting its potential for an ultra-rare disease with substantial unmet need - Traws' strategic objective for its legacy oncology assets (rigosertib and narazaciclib) is to establish additional partnerships for further development[6](index=6&type=chunk)[22](index=22&type=chunk) - Rigosertib is intended for the treatment of recessive dystrophic epidermolysis bullosa associated locally advanced or metastatic squamous cell carcinoma (RDEB SCC), an ultra-rare, complicated monogenic disease with a substantial unmet need and no approved therapies[7](index=7&type=chunk)[13](index=13&type=chunk) - Key clinical efficacy data for rigosertib in RDEB SCC showed a compelling **overall response rate of 80%**, with **complete responses in 50%** of evaluable patients and good overall tolerability[13](index=13&type=chunk) - Traws is actively seeking partnership opportunities to support further development of rigosertib[13](index=13&type=chunk) [Corporate Updates](index=5&type=section&id=corporate_updates) [Management Updates](index=5&type=section&id=management_updates) Traws Pharma announced several management changes, including Jack Stover being named Chairman of the Board and Charles Parker appointed Interim Chief Financial Officer, while Iain D. Dukes transitioned to Board Member with expanded responsibilities as Interim CEO - Jack Stover was named Chairman of the Board on April 15, 2025[13](index=13&type=chunk) - Iain D. Dukes transitioned to Board Member, with expanded responsibilities as Interim Chief Executive Officer (announced March 31, 2025)[13](index=13&type=chunk) - Charles Parker was named Interim Chief Financial Officer (CFO) on July 5, 2025[13](index=13&type=chunk) [Conference Call and Webcast Information](index=5&type=section&id=conference_call_webcast_information) Traws hosted a conference call on August 14, 2025, at 8:30 AM ET to discuss Q2 results and pipeline progress, with a replay available on the Investors section of their website - Traws hosted a conference call on August 14, 2025, at 8:30 AM ET to discuss its Q2 results and pipeline progress[9](index=9&type=chunk) - A replay of the webcast is available on the Investors section of the Traws website[10](index=10&type=chunk) [Financial Results](index=5&type=section&id=financial_results) [Q2 2025 Financial Highlights](index=5&type=section&id=q2_2025_financial_highlights) Traws Pharma reported a significant increase in Q2 2025 revenue to $2.7 million, primarily from deferred revenue recognition, a substantial reduction in net loss to $0.9 million due to the absence of a prior year's one-time charge for acquired in-process R&D, and reductions in cash, R&D, and G&A expenses [Cash, Cash Equivalents and Short-Term Investments](index=5&type=section&id=cash_cash_equivalents_short_term_investments) As of June 30, 2025, Traws Pharma reported approximately $13.1 million in cash, cash equivalents, and short-term investments, a decrease from $21.3 million as of December 31, 2024 Cash, Cash Equivalents and Short-Term Investments | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash, cash equivalents, and short-term investments | $13.1 million | $21.3 million | -$8.2 million | [Revenue](index=5&type=section&id=revenue) Revenue for Q2 2025 significantly increased to $2.7 million from $57 thousand in Q2 2024, primarily due to the recognition of deferred revenue from the mutual termination of a legacy oncology licensing agreement Revenue (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------- | :-------- | :-------- | :----- | | Revenue | $2,733,000 | $57,000 | +$2,676,000 | - The increase in Q2 2025 revenue was attributable to **$2.7 million** in deferred revenue recognized from the mutual termination of a licensing agreement associated with a legacy oncology program[12](index=12&type=chunk) [Operating Expenses](index=6&type=section&id=operating_expenses) Total operating expenses for Q2 2025 decreased significantly to $3.98 million from $123.41 million in Q2 2024, primarily due to the absence of a large one-time charge for acquired in-process R&D from the prior year, with R&D and G&A expenses also seeing reductions Total Operating Expenses (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------- | :-------- | :---------- | :----- | | Total Operating Expenses | $3,982,000 | $123,405,000 | -$119,423,000 | [Research and Development (R&D) Expense](index=6&type=section&id=research_development_expense) R&D expense for Q2 2025 decreased by $1.7 million to $2.3 million compared to $4.0 million in Q2 2024, mainly due to reduced oncology program and personnel expenses, partially offset by increased virology program expenses Research and Development Expense (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :---------------------- | :-------- | :-------- | :----- | | Research and Development | $2,291,000 | $3,964,000 | -$1,673,000 | - The decrease was primarily related to a decrease in expenses for the oncology program and personnel expenses, partially offset by an increase in expenses for virology programs[14](index=14&type=chunk) [General and Administrative (G&A) Expense](index=6&type=section&id=general_administrative_expense) G&A expense for Q2 2025 decreased by $0.3 million to $1.7 million from $2.0 million in Q2 2024, mainly due to lower personnel-related expenses and stock-based compensation, partially offset by higher professional and consulting fees General and Administrative Expense (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------------ | :-------- | :-------- | :----- | | General and Administrative | $1,691,000 | $1,977,000 | -$286,000 | - The decrease was primarily attributable to a decrease in personnel-related expenses and stock-based compensation, partially offset by an increase in professional and consulting fees[15](index=15&type=chunk) [Net Income (Loss)](index=6&type=section&id=net_income_loss) Traws Pharma reported a net loss of $0.9 million ($0.11 per share) for Q2 2025, a substantial improvement from a net loss of $123.1 million ($20.52 per share) in Q2 2024, which included a one-time charge of $117.5 million for acquired in-process R&D Net Income (Loss) (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------------------------ | :-------- | :---------- | :----- | | Net (loss) income | $(915,000) | $(123,143,000) | +$122,228,000 | | Net (loss) income per share, basic | $(0.11) | $(20.52) | +$20.41 | - The significant improvement in net loss was due to the inclusion of a one-time charge of **$117.5 million** for acquired in-process research and development in the comparable period of 2024[15](index=15&type=chunk) [Shares Outstanding](index=6&type=section&id=shares_outstanding) As of August 13, 2025, Traws had 7,063,829 shares of common stock outstanding Shares Outstanding | Metric | As of August 13, 2025 | | :---------------------- | :-------------------- | | Common Stock Outstanding | 7,063,829 shares | [Condensed Consolidated Balance Sheets](index=9&type=section&id=condensed_consolidated_balance_sheets) As of June 30, 2025, total assets were $15.62 million, down from $24.96 million at December 31, 2024, primarily driven by a decrease in cash and cash equivalents; total liabilities also decreased significantly to $7.36 million from $56.59 million, largely due to the reduction in warrant liabilities and deferred revenue, while stockholders' equity turned positive to $8.26 million from a deficit of $31.63 million Condensed Consolidated Balance Sheets Highlights | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------ | :------------ | :---------------- | :----- | | Total assets | $15,622,000 | $24,962,000 | -$9,340,000 | | Cash and cash equivalents | $13,081,000 | $21,338,000 | -$8,257,000 | | Total current assets | $15,370,000 | $24,951,000 | -$9,581,000 | | Total liabilities | $7,360,000 | $56,592,000 | -$49,232,000 | | Warrant liabilities | $8,000 | $42,494,000 | -$42,486,000 | | Deferred revenue (current & non-current) | $0 | $2,791,000 | -$2,791,000 | | Total stockholders' equity (deficit) | $8,262,000 | $(31,630,000) | +$39,892,000 | [Condensed Consolidated Statements of Operations](index=10&type=section&id=condensed_consolidated_statements_of_operations) For the six months ended June 30, 2025, Traws reported a net income of $20.58 million, a significant turnaround from a net loss of $128.13 million in the prior year period, driven by a substantial increase in revenue and a large positive change in the fair value of warrant liability, alongside the absence of the prior year's acquired in-process R&D charge Condensed Consolidated Statements of Operations Highlights (Six Months Ended June 30) | Metric | 6 Months 2025 | 6 Months 2024 | Change | | :------------------------------------ | :------------ | :------------ | :----- | | Revenue | $2,790,000 | $113,000 | +$2,677,000 | | Acquired in-process R&D | $0 | $117,464,000 | -$117,464,000 | | Total operating expenses | $9,242,000 | $128,673,000 | -$119,431,000 | | Net (loss) income | $20,575,000 | $(128,126,000) | +$148,701,000 | | Net (loss) income per share, basic | $2.02 | $(37.45) | +$39.47 | | Change in fair value of warrant liability | $26,659,000 | $0 | +$26,659,000 | [Product Information](index=6&type=section&id=product_information) [About Ratutrelvir](index=6&type=section&id=about_ratutrelvir) Ratutrelvir is an investigational oral, small molecule Mpro inhibitor for SARS-CoV-2/COVID-19, designed to be ritonavir-independent to avoid drug-drug interactions and enable wider patient use; Phase 1 data showed sustained target blood plasma levels, potentially reducing clinical rebound and Long COVID risk, with the COVID treatment market representing a potential multi-billion dollar opportunity - Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed as a broadly acting, ritonavir-independent treatment for SARS-CoV-2/COVID-19[17](index=17&type=chunk) - It aims to avoid ritonavir-associated drug-drug interactions, potentially enabling wider patient use, and has demonstrated in vitro activity against a range of virus strains[17](index=17&type=chunk) - Phase 1 data showed maintenance of target blood plasma levels approximately **13 times above the EC50**, which may reduce the likelihood of clinical rebound and the risk for Long COVID[17](index=17&type=chunk) - The COVID treatment market represents a potential **multi-billion dollar opportunity**[17](index=17&type=chunk) [About Tivoxavir Marboxil](index=6&type=section&id=about_tivoxavir_marboxil) Tivoxavir marboxil (TXM) is an investigational oral, single-dose CAP-dependent endonuclease inhibitor for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains, including H5N1, and consistent positive preclinical data across three animal species demonstrating therapeutic effect against H5N1 bird flu; the seasonal influenza antiviral market is a multi-billion dollar opportunity, with additional upside from potential pandemic outbreaks and stockpiling initiatives - Tivoxavir marboxil (TXM) is 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[18](index=18&type=chunk) - It has shown potent in vitro activity against a range of influenza strains, including a human isolate of the highly pathogenic avian flu H5N1[18](index=18&type=chunk) - Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu[18](index=18&type=chunk) - The seasonal influenza antiviral market is an estimated **multi-billion dollar opportunity**, largely driven by global health organizations, practice guidelines, government tenders, and inclusion in drug stockpiling initiatives, with upside potential from pandemic flu outbreaks[18](index=18&type=chunk) [About Traws Pharma, Inc.](index=7&type=section&id=about_traws_pharma_inc) Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel oral small molecule antiviral agents for critical respiratory viral diseases like COVID-19/Long COVID (Ratutrelvir, Mpro inhibitor) and bird flu/seasonal influenza (Tivoxavir marboxil, CEN inhibitor), also seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib - Traws Pharma is a clinical-stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases[21](index=21&type=chunk) - The company is advancing novel investigational oral small molecule antiviral agents: Ratutrelvir (ritonavir-independent COVID treatment, Mpro inhibitor) and Tivoxavir marboxil (single-dose bird flu and seasonal influenza treatment, CEN inhibitor)[21](index=21&type=chunk) - Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib[22](index=22&type=chunk) [Additional Information](index=8&type=section&id=additional_information) [Forward-Looking Statements](index=8&type=section&id=forward_looking_statements) The release contains forward-looking statements regarding Traws' business, product candidates, market opportunities, clinical and regulatory plans, and legacy programs; these statements involve known and unknown risks and uncertainties, including clinical trial success, regulatory interactions, market conditions, and the ability to raise capital, with Traws undertaking no obligation to update these statements except as required by law - The release contains forward-looking statements regarding the Company, its business and product candidates, including potential opportunity, market size, benefits, effectiveness, safety, and clinical/regulatory plans[25](index=25&type=chunk) - These statements involve known and unknown risks, uncertainties, and other factors, including the success and timing of clinical trials, interactions with regulatory bodies (FDA, BARDA), market conditions, and the ability to raise additional capital[25](index=25&type=chunk) - Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law[25](index=25&type=chunk) [Contact Information](index=8&type=section&id=contact_information) Contact information for Traws Pharma (Charles Parker) and Investor Relations (John Fraunces of LifeSci Advisors, LLC) is provided for inquiries - Contact information for Traws Pharma (Charles Parker) and Investor Contact (John Fraunces, LifeSci Advisors, LLC) is provided[26](index=26&type=chunk)

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Or Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Commission file number: 001-36020 Traws Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 22-3627252 (State or other jurisdiction of (I.R.S. Employ ...

Core Insights - Traws Pharma is advancing its antiviral programs targeting respiratory viruses, particularly focusing on ratutrelvir for COVID-19 and Tivoxavir marboxil (TXM) for influenza, in response to ongoing health threats and the need for effective treatments [1][20] - The company has submitted a Phase 2 study for ratutrelvir to evaluate its efficacy against PAXLOVID in newly diagnosed COVID patients, with results expected by the end of 2025 [3][5] - TXM is being positioned for stockpiling readiness, with ongoing discussions with BARDA for inclusion in pandemic preparedness initiatives [2][5] Product Development - Ratutrelvir is a ritonavir-free oral protease inhibitor designed for once-daily dosing over 10 days, showing promising Phase 1 results with plasma drug levels maintained significantly above the effective concentration [5][15] - TXM is an investigational single-dose treatment for bird flu and seasonal influenza, demonstrating strong preclinical efficacy against H5N1 and good tolerability in animal models [5][16] - The U.S. market opportunity for both products is estimated to be multi-billion dollars, driven by the ongoing need for effective antiviral treatments [5][15][16] Financial Performance - For Q2 2025, Traws reported revenue of $2.7 million, a significant increase from $57,000 in the same period in 2024, primarily due to deferred revenue recognition from a terminated licensing agreement [11][27] - Research and development expenses decreased to $2.3 million from $4.0 million year-over-year, reflecting a strategic shift in focus towards virology programs [12][13] - The net loss for Q2 2025 was $0.9 million, a substantial improvement compared to a net loss of $123.1 million in Q2 2024, which included a one-time charge related to an acquisition [13][29] Management and Corporate Updates - Traws will host a business update call on August 14, 2025, to discuss its Q2 results and pipeline progress [8] - Recent management changes include the appointment of Jack Stover as Chairman of the Board and Charles Parker as Interim CFO [13][21] - The company is actively seeking partnerships for its legacy oncology programs, including rigosertib and narazaciclib, to support further development [21]

Core Insights - Traws Pharma is advancing its antiviral pipeline with multiple regulatory submissions for tivoxavir marboxil (TXM) and ratutrelvir, targeting seasonal and bird flu as well as COVID-19 [1][2][3] Group 1: Tivoxavir Marboxil (TXM) - A Phase 2 study protocol has been submitted to evaluate TXM in patients with seasonal influenza and H5N1 bird flu, aiming for a non-inferiority comparison with XOFLUZA® [2][3] - The study will enroll subjects in Australia and Southeast Asia, regions with high rates of human bird flu infections, to assess TXM's efficacy [2][3] - Traws Pharma is in discussions with the FDA regarding accelerated approval pathways for TXM under the Animal Rule [4][3] - TXM is designed as a single-dose oral treatment with demonstrated in vitro activity against various influenza strains, including H5N1 [8] Group 2: Ratutrelvir - A separate Phase 2 study protocol has been submitted for ratutrelvir, a protease inhibitor for newly diagnosed COVID patients, comparing it to PAXLOVID [4][6] - The study will evaluate a 10-day treatment regimen for ratutrelvir against the 5-day regimen for PAXLOVID, focusing on efficacy, safety, disease rebound, and Long COVID incidence [4][5] - Ratutrelvir is positioned as a ritonavir-independent treatment, potentially broadening its use among patients ineligible for PAXLOVID [9][6] Group 3: Market Potential - The seasonal influenza antiviral market represents a multi-billion dollar opportunity, driven by global health organizations and potential pandemic outbreaks [8] - The COVID-19 treatment market also presents significant potential, with ratutrelvir aiming to address gaps in existing therapies [9]

NEWTOWN, Pa., June 03, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced the publication of key clinical efficacy data for rigosertib, a legacy Traws Pharma oncology asset for which development and commercialization partners are being actively sought, in patients with RDEB SCC. The paper, publish ...

Core Viewpoint - Traws Pharma is advancing the development of tivoxavir marboxil (TXM) as a treatment for bird flu and seasonal influenza, with recent FDA feedback guiding their regulatory strategy and clinical study plans [1][2][3]. Group 1: FDA Interaction and Development Plans - The FDA provided written responses regarding the development paths for TXM, including the potential use of the Animal Rule for approval [1][2]. - Traws Pharma is requesting a Type D meeting with the FDA to clarify next steps in the development process for TXM [2]. - The company aims to conduct a combined clinical study involving subjects infected with seasonal and bird flu [2]. Group 2: Therapeutic Efficacy and Urgency - Positive therapeutic effects of TXM have been observed in three animal models of bird flu, reinforcing the need for rapid progression towards stockpiling and pandemic readiness [3]. - Traws Pharma has initiated discussions with the Biomedical Advanced Research and Development Authority (BARDA) for stockpiling TXM in preparation for potential pandemics [3]. - The historical context of H5N1 virus outbreaks, which have had death rates up to 50%, underscores the urgency of these actions [3]. Group 3: Product Overview and Market Opportunity - TXM is an investigational oral small molecule designed as a single-dose treatment for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains [4]. - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government tenders, with additional potential from pandemic outbreaks [4]. - The data supporting TXM's development as a treatment for both bird flu and seasonal flu is considered robust [4].

PART I — FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents unaudited Q1 2025 financial statements, reporting a **$21.5 million** net income, **$19.1 million** in assets, and **$15.9 million** cash, while noting going concern doubts and a **$2.7 million** revenue recognition in April 2025 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$19.1 million**, liabilities significantly reduced to **$13.1 million**, and stockholders' equity improved to a positive **$6.0 million** Condensed Consolidated Balance Sheet Highlights (unaudited) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,937,000 | $21,338,000 | | Total assets | $19,063,000 | $24,962,000 | | Warrant liabilities | $154,000 | $42,494,000 | | Total liabilities | $13,063,000 | $56,592,000 | | Total stockholders' equity (deficit) | $6,000,000 | $(31,630,000) | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, the company reported a net income of **$21.5 million** (vs. **$5.0 million** loss in Q1 2024), primarily due to a **$26.5 million** gain from warrant liability fair value changes Condensed Consolidated Statements of Operations (unaudited, in thousands, except per share data) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $57 | $56 | | Research and development | $2,506 | $1,912 | | General and administrative | $2,754 | $3,356 | | Loss from operations | $(5,203) | $(5,212) | | Change in fair value of warrant liability | $26,513 | $— | | Net income (loss) | $21,490 | $(4,983) | | Net income (loss) per share, basic | $2.17 | $(5.92) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$5.4 million** in Q1 2025, resulting in a **$5.4 million** decrease in cash and equivalents, ending the period at **$15.9 million** Condensed Consolidated Statements of Cash Flows Highlights (unaudited, in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,437) | $(4,424) | | Net cash provided by financing activities | $13 | $— | | Net decrease in cash and cash equivalents | $(5,401) | $(4,431) | | Cash and cash equivalents at end of period | $15,937 | $16,390 | - The company's primary focus is on developing tivoxavir marboxil for bird flu and ratutrelvir for COVID-19, with oncology programs narazaciclib and rigosertib targeted for partnerships[23](index=23&type=chunk) - As of March 31, 2025, the company held **$15.9 million** in cash and equivalents with an accumulated deficit of **$627.7 million**, leading management to conclude substantial doubt about its ability to continue as a going concern[25](index=25&type=chunk) - Effective April 17, 2025, the Symbio license agreement was terminated, resulting in the recognition of **$2.7 million** in deferred revenue in April 2025[99](index=99&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial performance, liquidity, and strategic focus, highlighting **$15.9 million** cash, going concern doubts, increased R&D for virology programs, and an ATM offering agreement - The company's portfolio includes four clinical programs, with primary focus on the two antiviral programs, **tivoxavir marboxil** and **ratutrelvir**, acquired in the Merger[110](index=110&type=chunk) Comparison of Operating Expenses (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 | Q1 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2.5M | $1.9M | +$0.6M | +31% | | General and administrative | $2.8M | $3.4M | -$0.6M | -18% | - The increase in R&D expenses was primarily driven by a **$1.7 million** increase in spending on virology programs, reflecting the strategic shift post-Trawsfynydd merger[135](index=135&type=chunk) - The company entered an ATM Offering Agreement in March 2025 to sell up to **$50 million** in common stock, raising **$0.1 million** in net proceeds during Q1 2025[118](index=118&type=chunk)[138](index=138&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Traws Pharma is not required to provide quantitative and qualitative disclosures about market risk[151](index=151&type=chunk) [Controls and Procedures](index=55&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025, due to un-remediated material weaknesses from an insufficient post-merger risk assessment and inadequate segregation of duties - Management concluded that disclosure controls and procedures were not effective as of March 31, 2025[152](index=152&type=chunk) - The ineffectiveness stems from material weaknesses identified in the 2024 Annual Report, specifically an insufficient post-Merger risk assessment process and inadequate segregation of duties[155](index=155&type=chunk) - A remediation plan is underway, aiming to resolve the material weaknesses before December 31, 2025[157](index=157&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=57&type=section&id=Item%201.%20Legal%20Proceedings) The company is in arbitration over a severance claim from its former President, Dr. Steven M. Fruchtman, with a potential loss estimated between zero and **$1.5 million** - The company is in a legal dispute with former President Dr. Steven M. Fruchtman over severance claims following his resignation[68](index=68&type=chunk)[158](index=158&type=chunk) - The company estimates a potential loss from this claim between zero and **$1.5 million**, with the matter currently in arbitration[68](index=68&type=chunk) [Risk Factors](index=57&type=section&id=Item%201A.%20Risk%20Factors) No material changes have been made to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes have been made to the risk factors disclosed in the Annual Report[160](index=160&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=57&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2025, the company had no unregistered sales of securities not previously reported and did not repurchase any outstanding equity securities - There were no unregistered sales of securities during the three months ended March 31, 2025, that were not already reported[161](index=161&type=chunk) - The Company did not repurchase any of its equity securities during the quarter[162](index=162&type=chunk) [Other Information](index=59&type=section&id=Item%205.%20Other%20Information) For Q1 2025, no directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter[165](index=165&type=chunk) [Exhibits](index=60&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the Form 10-Q, including warrant amendments, separation agreements, and the ATM Offering Agreement - The report includes several key exhibits, such as amendments to Series A and Pre-Funded Warrants, separation agreements, an employment agreement, and the ATM Offering Agreement[167](index=167&type=chunk)

Financial Performance - Revenue for the quarter ended March 31, 2025, was $57 thousand, a slight increase from $56 thousand for the same period in 2024[10] - Total revenue for the three months ended March 31, 2025, was $57,000, a slight increase from $56,000 in the same period of 2024, representing a growth of approximately 1.79%[24] - The net income for the quarter was $21.5 million, significantly improved from a net loss of $5.0 million in the same quarter of 2024, driven by a change in fair value of warrant liability[12] - The net income for Q1 2025 was $21,490,000, compared to a net loss of $4,983,000 in Q1 2024, indicating a significant turnaround[24] - Net income per share of common stock for Q1 2025 was $2.17, compared to a loss of $5.92 per share in Q1 2024[24] Expenses - Research and development (R&D) expenses for the quarter totaled $2.5 million, up from $1.9 million in the comparable period in 2024, primarily due to increased expenses related to virology programs[10] - Research and development expenses increased to $2,506,000 in Q1 2025, up from $1,912,000 in Q1 2024, reflecting a rise of 30.96%[24] - General and administrative (G&A) expenses decreased to $2.8 million from $3.4 million in the same period in 2024, mainly due to reduced consulting fees[11] - General and administrative expenses decreased to $2,754,000 in Q1 2025, down from $3,356,000 in Q1 2024, a reduction of 17.91%[24] Assets and Liabilities - As of March 31, 2025, Traws Pharma had cash, cash equivalents, and short-term investments of approximately $15.9 million, down from $21.3 million as of December 31, 2024[9] - Total current assets decreased to $18,856,000 as of March 31, 2025, down from $24,951,000 as of December 31, 2024, a decline of 24.43%[22] - Total liabilities significantly decreased to $13,063,000 as of March 31, 2025, compared to $56,592,000 as of December 31, 2024, a reduction of 76.98%[22] - Stockholders' equity improved to $6,000,000 as of March 31, 2025, from a deficit of $31,630,000 as of December 31, 2024[22] Product Development and Regulatory Activities - Traws Pharma is preparing to submit a briefing package for ratutrelvir to regulatory authorities in Q2 2025, targeting acute COVID treatment and Long COVID prevention[6] - Tivoxavir marboxil (TXM) is positioned for a multi-billion dollar market opportunity in the U.S. for bird flu and seasonal flu treatments, with ongoing preparations for regulatory approval[7] - Phase 1 data for TXM indicated that it maintained plasma blood levels above the EC90 for approximately three weeks after a single oral dose, supporting its use as a single-dose treatment[7] - Ratutrelvir's pharmacokinetic profile showed maintenance of target blood plasma levels approximately 13 times above the EC50, indicating potential effectiveness against COVID-19[15] Strategic Initiatives - Traws Pharma is seeking partnership opportunities for its legacy oncology assets, narazaciclib and rigosertib[6] Changes in Fair Value - The change in fair value of warrant liability contributed $26,513,000 to the income statement in Q1 2025, with no comparable figure in Q1 2024[24] Shareholder Information - The weighted-average shares of common stock outstanding increased to 6,965,927 in Q1 2025, compared to 841,738 in Q1 2024, reflecting a substantial increase in shares[24]