Traws Pharma, Inc.(TRAW) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights Company Overview and 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] - Antivirals are emphasized for their dual therapeutic (eliminating viral infections) and prophylactic (preventing viral infections or spreading) benefits, unlike vaccines[3] CEO's 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] - 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] - 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] PAXLOVID Sales Performance (Q2 2025) | Metric | Q2 2025 Sales | | :----- | :------------ | | PAXLOVID | $427 million | | YoY Increase | 70% | CMO & CSO Perspectives on 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] - 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] - 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] - 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] Recent Highlights and Anticipated Milestones 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][8] - 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] - The U.S. market opportunity for COVID treatment is estimated to be a multi-billion dollar market[8] - 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] - 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] 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][8] - 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] - 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] - 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] - Next steps include advancing discussions with BARDA and other regulatory agencies regarding TXM's inclusion in drug stockpiling initiatives for pandemic preparedness[8] 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][22] - 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][13] - 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] - Traws is actively seeking partnership opportunities to support further development of rigosertib[13] Corporate Updates 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] - Iain D. Dukes transitioned to Board Member, with expanded responsibilities as Interim Chief Executive Officer (announced March 31, 2025)[13] - Charles Parker was named Interim Chief Financial Officer (CFO) on July 5, 2025[13] Conference Call and 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] - A replay of the webcast is available on the Investors section of the Traws website[10] Financial Results 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 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 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] 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 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] General and Administrative (G&A) 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] 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] 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 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 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 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] - 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] - 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] - The COVID treatment market represents a potential multi-billion dollar opportunity[17] 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] - 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] - Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu[18] - 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] 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] - 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] - Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib[22] Additional Information 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] - 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] - 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] 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]