Core Insights - Traws Pharma announced promising clinical efficacy data for rigosertib, showing an overall response rate of 80% and complete responses in 50% of evaluable patients with RDEB-associated SCC [1][2][4] - Rigosertib is being positioned as a potential treatment for cutaneous SCC in RDEB patients, addressing a significant unmet medical need [2][4] - The company is actively seeking partners for the development and commercialization of rigosertib [3][9] Group 1: Clinical Data - The publication in the British Journal of Dermatology marks the first clinical trial of any experimental cancer therapeutic in RDEB-associated SCC [1] - The aggressive nature of RDEB-associated SCC results in a cumulative risk of death of 70% by age 45 and 78.7% by age 55 [4] Group 2: Company Strategy - Traws Pharma is committed to finding a partner to advance rigosertib towards approval [3] - The company is also developing antiviral agents targeting various viral diseases, indicating a broader therapeutic focus [8]

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]

Core Insights - Traws Pharma is advancing two investigational antiviral therapies: tivoxavir marboxil (TXM) for bird flu and seasonal flu, and ratutrelvir for COVID-19, including Long COVID [2][3][4] - The company aims to accelerate the approval process for these therapies through regulatory interactions, including a briefing submitted to the FDA for TXM [3][4] - Financial results indicate a net income of $21.5 million for Q1 2025, primarily due to a change in fair value of warrant liability, contrasting with a net loss of $5.0 million in Q1 2024 [6][9] Product Development - **Tivoxavir Marboxil (TXM)**: - A single-dose investigational CAP-dependent endonuclease inhibitor targeting H5N1 bird flu and seasonal flu, with a multi-billion dollar market opportunity [4][12] - Recent studies show significant antiviral activity, including reduced viral burden in animal models [4][10] - Preparations for FDA discussions regarding accelerated approval are ongoing [10] - **Ratutrelvir**: - An investigational oral Main protease inhibitor for acute COVID treatment, with potential to prevent COVID rebound and Long COVID [5][10] - Preclinical studies indicate potent suppression of resistant virus and favorable pharmacokinetic profiles [10][13] Financial Overview - As of March 31, 2025, Traws Pharma had approximately $15.9 million in cash and equivalents, down from $21.3 million at the end of 2024, sufficient to support operations into Q1 2026 [6][21] - Revenue for Q1 2025 was $57,000, slightly up from $56,000 in Q1 2024 [6][24] - R&D expenses increased to $2.5 million in Q1 2025 from $1.9 million in Q1 2024, reflecting heightened investment in virology programs [7][24] - General and administrative expenses decreased to $2.8 million in Q1 2025 from $3.4 million in Q1 2024 [8][24] Management Updates - Iain D. Dukes was appointed Interim CEO following the retirement of Werner Cautreels [5] - Jack Stover was named Chairman of the Board on April 15, 2025 [5]

Bird Flu - Tivoxavir marboxil (TXM) - TXM demonstrates a broad resistance profile against avian flu strains, including the "Texas dairy worker strain"[16] - A single dose of TXM provided protection from disease and mortality in three preclinical models[17] - Phase 1 data showed that a single 480 mg dose of TXM maintained plasma blood levels above the EC90 for approximately 3 weeks in healthy volunteers[18, 60] - The company submitted a pre-IND meeting request to the FDA on March 21, 2025, to seek accelerated approval under the Animal Rule[63, 102] - In mice infected with bird flu, TXM provided 100% protection against lethal bird flu challenge[26] - In ferrets infected with bird flu, TXM doses increased survival, with the 240 mg human equivalent dose resulting in 50% survival compared to 0% in the control group[36, 47] - In non-human primates infected with bird flu, a single dose of TXM significantly lowered lung viremia and prevented virus-induced weight loss[50, 51] COVID-19 - Ratutrelvir - Ratutrelvir exhibits a broad resistance profile against native, emerging variants, and treatment-resistant strains compared to nirmatrelvir and ibuzatrelvir[75] - At the recommended Phase 2 dose (RP2D), ratutrelvir maintains favorable pharmacokinetics, with plasma drug levels approximately 13 times the EC50 and high lung accumulation[76] - Phase 1 data indicate that ratutrelvir's drug metabolism is not induced, supporting its ritonavir-independent use[78] - A daily oral 600 mg dose of ratutrelvir sustains drug levels above EC90 for 10 days in healthy volunteers[88] Financials and Outlook - As of December 31, 2024, the company's cash, cash equivalents, and short-term investments totaled $213 million, supporting planned operations into Q1 2026[104]

Company Overview - Traws Pharma, Inc. focuses on developing novel antiviral therapies targeting respiratory viral diseases, expanding its business after a merger with Trawsfynydd Therapeutics, Inc. on April 1, 2024[18]. - The company has four clinical programs: tivoxavir marboxil for influenza, ratutrelvir for COVID-19, narazaciclib for cancer, and rigosertib for various cancers[18]. Clinical Programs and Trials - Tivoxavir marboxil demonstrated a 100% protection rate in mice against H5N1 bird flu at a dose of 50 mg/kg, which is comparable to a human dose of 240 mg[26]. - In a Phase 1 clinical trial in Australia, tivoxavir marboxil maintained plasma drug levels above the EC90 for over 23 days after a single dose[22]. - Ratutrelvir showed non-inferiority to the combination of nirmatrelvir and ritonavir in an animal study, indicating its potential effectiveness against SARS-CoV-2[35]. - The Phase 1 trial for ratutrelvir included 40 participants, with a maximum dose of 600 mg showing no adverse events related to the study drug[36]. - Narazaciclib is a multi-targeted kinase inhibitor with a differentiated profile, potentially overcoming limitations of current CDK 4/6 inhibitors[38]. - Traws Pharma plans to meet with the FDA in the first half of 2025 to discuss accelerated approval for tivoxavir marboxil under the "Animal Rule" for H5N1 bird flu treatment[24]. - The company has conducted extensive pre-clinical studies on tivoxavir marboxil, demonstrating significant antiviral effects in multiple animal models[25]. - Ratutrelvir maintained plasma drug levels within the therapeutic window for 12 days, with 24-hour trough levels constant at approximately 110 nM[37]. - Narazaciclib demonstrates a favorable kinase inhibitory profile compared to approved CDK4/6 inhibitors, potentially leading to both tumorigenic and safety benefits[45]. - In a Phase 1 study in China, 75% of enrolled patients had metastatic breast cancers, with 2 out of 3 patients treated at the 200mg dose achieving stable disease[47]. - The maximum tolerated dose for narazaciclib in combination with letrozole was established at 160mg once daily, with no dose limiting toxicities observed in the initial cohort[51]. - The IND submission for narazaciclib to the US FDA was completed in November 2020, with enrollment for the US Phase 1 study commencing in May 2021[48]. - Narazaciclib inhibits CSF1R with IC50 values between 0.7 to 10 nM, indicating potential impact on cancers dependent on CSF1R signaling[40]. - The combination of CDK and ARK5 inhibitors in narazaciclib is proposed to have a differentiated effect on cancer cells by inhibiting both cytostatic and cytotoxic pathways[39]. - The Phase 1 study of narazaciclib in the US involved escalating daily doses starting at 40mg, with the highest tested dose being 280mg[50]. - The clinical experience with rigosertib in RDEB-associated SCC showed 2 complete cutaneous responses in 4 evaluable patients, with durable responses lasting 15 and 16 months[56]. - Rigosertib's safety profile appears acceptable, with preliminary data supporting its activity against PLK1 in RDEB-associated SCC[57]. Financial Overview - Research and development expenses amounted to $12.8 million and $11.4 million for the years ended December 31, 2024 and 2023, respectively, indicating a focus on clinical-stage product candidates[61]. - The company reported recurring operating losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern without obtaining adequate new financings[198]. - The independent registered accounting firm's report for the fiscal year ended December 31, 2024, contains an explanatory paragraph regarding the company's ability to continue as a going concern[200]. - The company has identified material weaknesses in its internal control over financial reporting, which could impair its ability to produce timely and accurate financial statements[200]. - The company reported net losses of $166.5 million for the year ended December 31, 2024, compared to a net loss of $18.9 million for the year ended December 31, 2023, with an accumulated deficit of $649.2 million as of December 31, 2024[210]. - The company has incurred significant losses since its inception in 1998 and anticipates continuing to incur losses in the future due to ongoing research and development expenses[210]. - The company has not generated any revenue from product sales to date and may never become profitable[215]. - The company plans to explore various financing options, including equity financings and strategic alliances, to alleviate concerns about its ability to continue operations[204]. - As of December 31, 2024, the company had cash and cash equivalents of $21.3 million and current liabilities of $11.5 million, raising substantial doubt about its ability to continue as a going concern for the next twelve months[203]. Regulatory Environment - The regulatory process for obtaining marketing approvals is extensive and costly, requiring significant time and financial resources[105][107]. - The FDA is the main regulatory body for biopharmaceuticals in the United States, and non-compliance can lead to severe sanctions[108]. - The FDA has a goal of completing its review of New Drug Applications (NDAs) for new molecular entities within 10 months of acceptance for filing[124]. - The FDA may require a substantial user fee for NDA submissions, which can be waived in certain instances[124]. - An approval letter from the FDA authorizes commercial marketing of the drug with specific prescribing information for designated indications[128]. - Post-approval requirements may include Phase 4 clinical trials and ongoing safety monitoring to assess the drug's effectiveness after commercialization[131]. - The FDA's approval process for new chemical entities (NCE) grants five years of marketing exclusivity, preventing ANDA or 505(b)(2) applications for the same active moiety during this period[143]. - The FDA allows for a patent term extension of up to five years for relevant drug patents, calculated based on the drug's testing and review phases, with a maximum total patent term of 14 years from the date of approval[145]. - The FDA's Orphan Drug Designation provides seven years of market exclusivity for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[159]. - The FDA's priority review designation sets a target action date of six months for drugs that provide significant improvements in treatment for serious conditions[165]. - The FDA's Fast Track designation allows for more frequent development meetings and a rolling review process for drugs addressing unmet medical needs[164]. - The FDA's Animal Rule permits approval of certain drugs based on animal studies when human efficacy studies are not ethical or feasible[154]. - The FDA's Breakthrough Therapy designation allows for expedited development and review of drugs that show substantial improvement over existing therapies for serious conditions[168]. - The Clinical Trials Regulation (EC) 536/2014 enables a single application for cross-border trials within the EU, streamlining the approval process[147]. Competitive Landscape - The biotechnology and pharmaceutical industries are highly competitive, with many competitors having greater financial and technical resources, leading to intense competition for product development and FDA approvals[96][97]. - The company is aware of various approved drugs for influenza treatment, including oseltamivir phosphate (Tamiflu) and baloxavir marboxil (Xofluza), highlighting the competitive landscape[98]. - Several companies have advanced drug candidates for COVID-19, including remdesivir and oral Paxlovid, which have received full FDA approval[99]. - The company faces substantial competition, which may result in others commercializing products before it does[201]. Operational Risks - The company relies on third parties for conducting preclinical and clinical trials, and any failure by these parties could delay regulatory approval[202]. - The company has limited experience in large-scale manufacturing and is dependent on third-party manufacturers, which could lead to delays[202]. - The company may face significant liabilities from product liability lawsuits, which could limit commercialization of its products[201]. - The company may be subject to securities litigation, which could divert management attention and incur expenses[202]. Economic and Market Conditions - The company is currently operating in a period of economic uncertainty and capital markets disruption, which could adversely affect its financial condition and results of operations[219]. - The ongoing military conflicts and geopolitical tensions could negatively impact the global economy and financial markets, potentially affecting the company's ability to obtain additional funding[223]. - International trade disputes may lead to tariffs and protectionist measures, adversely affecting the company's business and financial condition[224]. - Changes in U.S.-China relations and regulations could impact the company's operating results and ability to raise capital[225]. - Potential new legislation or tariffs may have negative effects on the company's financial condition and market share[227]. - Inflation may increase the company's overall cost structure, affecting liquidity and financial results[228]. - Higher interest rates and capital costs due to inflation could lead to supply shortages and increased operational costs[228].

[Traws Pharma Full Year 2024 Results and Business Highlights](index=1&type=section&id=Traws%20Pharma%20Reports%20Full%20Year%202024%20Results%20and%20Business%20Highlights) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted Traws Pharma's strategic pivot to respiratory diseases, prioritizing H5N1 bird flu, with positive TXM data and successful 2024 financing - The company redefined its focus to treat critical respiratory disease threats, prioritizing **bird flu**[3](index=3&type=chunk) - Positive preclinical data for **tivoxavir marboxil (TXM)** showed potent resistance and robust antiviral activity in flu models, with positive Phase 1 pharmacokinetic results[3](index=3&type=chunk) - A successful December 2024 financing provided Traws with **$20 million** in gross proceeds and new institutional healthcare investors[3](index=3&type=chunk) - The company is pursuing a potential accelerated approval path for **TXM** under the FDA's Animal Rule[3](index=3&type=chunk) [Upcoming Milestones and Recent Highlights](index=1&type=section&id=Upcoming%20Milestones%20and%20Recent%20Highlights) Traws Pharma outlines key Q2 2025 milestones for bird flu and COVID programs, alongside recent positive data and management changes [Upcoming Milestones (Q2 2025)](index=1&type=section&id=Upcoming%20Milestones) For Q2 2025, the company plans FDA updates on its bird flu Animal Rule and a pre-IND meeting request for its COVID program's long COVID endpoints - Bird Flu Program: Provide an update on FDA discussions regarding the **Animal Rule in Q2 2025** and finalize the development plan[6](index=6&type=chunk) - COVID Program: Submit a pre-IND meeting request to the FDA in **Q2 2025** to understand long COVID endpoints[6](index=6&type=chunk) [Recent Highlights](index=2&type=section&id=Recent%20Product%20Development%20%26%20Corporate%20Highlights) Recent highlights include positive TXM data from non-human primate and ferret studies, completed Phase 1, positive ratutrelvir data, and an Interim CEO appointment - Bird Flu (TXM): Announced positive topline results from studies in **non-human primates (Mar 2025)**, **ferrets (Mar 2025)**, and completed **Phase I studies (Jan 2025)**[7](index=7&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) - COVID (Ratutrelvir): Positive data supporting **ratutrelvir** as a treatment for COVID-19 was presented at the **ICAR 2025 conference**[11](index=11&type=chunk) - Corporate: CEO Werner Cautreels retired effective **March 31, 2025**, with Chairman Iain D. Dukes assuming the role of **Interim CEO**[12](index=12&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Financial Performance Summary (FY 2024)](index=2&type=section&id=Financial%20Performance%20Summary%20%28FY%202024%29) Traws Pharma ended 2024 with **$21.3 million** cash, projecting funding into Q1 2026, with net loss surging to **$166.5 million** due to significant R&D and warrant expenses Financial Performance Metrics | Metric | FY 2024 | FY 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $21.3 million | $20.8 million | | R&D Expense | $12.8 million | $11.4 million | | G&A Expense | $12.3 million | $9.1 million | | Net Loss | $166.5 million | $18.9 million | | Net Loss per Share | $35.21 | $22.57 | - The significant increase in net loss was primarily due to a **$117.5 million** acquired in-process research and development expense and a **$24.4 million** warrant expense from the December 2024 financing[16](index=16&type=chunk) - The company's cash balance of **$21.3 million** is projected to be sufficient to support operations into the **first quarter of 2026**[13](index=13&type=chunk) - As of **March 26, 2025**, there were **5,073,790 shares** of common stock outstanding, reflecting the issuance of **3.9 million shares** from the December 2024 financing[17](index=17&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=Traws%20Pharma%2C%20Inc.%20Consolidated%20Balance%20Sheets) As of December 31, 2024, total assets were **$25.0 million**, liabilities surged to **$56.6 million** due to **$42.5 million** in warrant liabilities, resulting in a **$31.6 million** stockholders' deficit Consolidated Balance Sheet Summary | | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | $24,951,000 | $22,660,000 | | **Total assets** | **$24,962,000** | **$22,683,000** | | **Total current liabilities** | $11,533,000 | $9,220,000 | | **Warrant liabilities** | $42,494,000 | $0 | | **Total liabilities** | **$56,592,000** | **$12,011,000** | | **Total stockholders' (deficit) equity** | **($31,630,000)** | **$10,672,000** | | **Total liabilities and stockholders' (deficit) equity** | **$24,962,000** | **$22,683,000** | [Consolidated Statements of Operations](index=6&type=section&id=Traws%20Pharma%2C%20Inc.%20Consolidated%20Statements%20of%20Operations) For FY 2024, Traws Pharma's revenues remained **$226,000**, with operating expenses surging to **$142.6 million** due to a **$117.5 million** acquired R&D expense, leading to a **$166.5 million** net loss Consolidated Statements of Operations Summary | | Year ended Dec 31, 2024 | Year ended Dec 31, 2023 | | :--- | :--- | :--- | | Revenue | $226,000 | $226,000 | | Acquired in-process R&D | $117,464,000 | $0 | | Research and development | $12,847,000 | $11,430,000 | | General and administrative | $12,289,000 | $9,094,000 | | **Total operating expenses** | **$142,600,000** | **$20,524,000** | | Loss from operations | ($142,374,000) | ($20,298,000) | | **Net loss** | **($166,523,000)** | **($18,948,000)** | | Net loss per share of common stock | ($35.21) | ($22.57) | [Product Pipeline Overview](index=3&type=section&id=Product%20Pipeline%20Overview) [Tivoxavir Marboxil (Bird Flu)](index=3&type=section&id=About%20Tivoxavir%20Marboxil) Tivoxavir marboxil (TXM) is an investigational oral, single-dose CAP-dependent endonuclease inhibitor for bird flu and seasonal influenza, demonstrating potent preclinical activity and consistent positive animal data - **TXM** is an investigational oral, single-dose drug designed to treat **bird flu** and **seasonal influenza** by inhibiting the CAP-dependent endonuclease[18](index=18&type=chunk) - Preclinical studies have shown potent in vitro activity against various influenza strains, including the highly pathogenic **H5N1 bird flu**[18](index=18&type=chunk) - The company believes the data supports further development of **TXM**, targeting a **multi-billion dollar antiviral market** with potential upside from pandemic flu outbreaks[18](index=18&type=chunk) [Ratutrelvir (COVID-19)](index=3&type=section&id=About%20Ratutrelvir) Ratutrelvir is an investigational oral Mpro inhibitor for COVID-19, designed without ritonavir to avoid drug interactions, with Phase 1 data suggesting reduced clinical rebound and long COVID risk - **Ratutrelvir** is an investigational oral **Mpro inhibitor** for COVID-19 that does not require co-administration with ritonavir[19](index=19&type=chunk) - Eliminating the need for ritonavir could avoid **drug-drug interactions**, making the treatment accessible to more patients[19](index=19&type=chunk) - **Phase 1 data** suggests the dosing regimen maintains target blood plasma levels that may reduce **clinical rebound** and the risk of **long COVID**[19](index=19&type=chunk) [About Traws Pharma & Forward-Looking Statements](index=4&type=section&id=About%20Traws%20Pharma%2C%20Inc.) [Company Overview](index=4&type=section&id=Company%20Overview) Traws Pharma is a clinical-stage biopharmaceutical company developing novel oral antiviral therapies for critical respiratory viral diseases, including tivoxavir marboxil and ratutrelvir - Traws Pharma is a **clinical-stage biopharmaceutical company** dedicated to developing novel therapies for **respiratory viral diseases**[20](index=20&type=chunk) - The company's two primary antiviral programs are **tivoxavir marboxil** (for bird flu/seasonal influenza) and **ratutrelvir** (for COVID-19)[21](index=21&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section serves as a standard legal disclaimer, cautioning that the press release contains forward-looking statements subject to inherent risks and uncertainties, advising investors to consult SEC filings for detailed risk factors - The release contains forward-looking statements regarding the company's plans, clinical trials, and product candidates, which involve inherent **risks and uncertainties**[23](index=23&type=chunk) - Readers are directed to the **"Risk Factors" section** in Traws' SEC filings for a detailed discussion of potential risks that could cause actual results to differ from expectations[23](index=23&type=chunk)

Core Insights - Traws Pharma is advancing tivoxavir marboxil (TXM) as a single-dose therapeutic for bird flu, supported by strong antiviral activity in animal models and positive Phase 1 clinical data [1][2][3] - The company is in discussions with the FDA regarding an accelerated approval pathway under the "Animal Rule" [1][2] - Traws Pharma has a cash runway that is expected to support operations into Q1 2026, following a successful financing round that raised $20 million [1][12] Recent Developments - Traws Pharma has declared bird flu as its top priority, with ongoing concerns about farm infections and mutated viruses posing a pandemic risk [2] - Positive preclinical data for TXM has been demonstrated in three validated flu models, showing robust antiviral activity [2][6][8] - The company completed Phase 1 studies for TXM, indicating its potential as a single-dose oral treatment for H5N1 bird flu [9] Financial Performance - As of December 31, 2024, Traws Pharma reported cash and cash equivalents of approximately $21.3 million, an increase from $20.8 million in 2023 [12] - Research and development expenses for 2024 totaled $12.8 million, up from $11.4 million in 2023, primarily due to clinical and preclinical trials [13] - The net loss for 2024 was $166.5 million, significantly higher than the $18.9 million loss in 2023, largely due to acquired in-process research and development expenses [15][28] Product Pipeline - Traws Pharma's lead product candidate, TXM, is designed to be a single-dose treatment for bird flu and has shown potent in vitro activity against various influenza strains [17][18] - The company is also developing ratutrelvir, a COVID-19 treatment that does not require co-administration with ritonavir, potentially broadening its patient use [19][21] - Upcoming milestones include finalizing the development plan for TXM and submitting a pre-IND meeting request for ratutrelvir to engage with the FDA [7][10]

Core Insights - Traws Pharma is advancing tivoxavir marboxil (TXM) as a single-dose therapeutic for bird flu, supported by strong antiviral activity in animal models and positive Phase 1 clinical data [1][2][17] - The company is in discussions with the FDA regarding an accelerated approval pathway under the "Animal Rule" [1][2][7] - Traws Pharma has sufficient cash reserves, approximately $21.3 million, to support operations into Q1 2026 [1][12] Recent Developments - Traws Pharma reported positive topline results from studies of TXM in non-human primates and ferrets, indicating its effectiveness against H5N1 bird flu [5][8] - The company completed a financing round in December 2024, raising $20 million, which has strengthened its investor base [2] - The upcoming investor call will cover public health risks related to bird flu and the regulatory strategy for TXM, as well as updates on the COVID-19 treatment candidate, ratutrelvir [3] Financial Performance - For the year ended December 31, 2024, Traws Pharma reported a net loss of $166.5 million, significantly higher than the $18.9 million loss in 2023, primarily due to acquired in-process research and development expenses [15][25] - Research and development expenses increased to $12.8 million from $11.4 million in the previous year, reflecting ongoing clinical trials [13] - General and administrative expenses rose to $12.3 million from $9.1 million, largely due to increased consulting fees [14] Market Opportunity - The market for seasonal influenza treatments is estimated to be a multi-billion dollar opportunity, with potential growth from pandemic threats like H5N1 bird flu [17][18] - Ratutrelvir, the company's COVID-19 candidate, is positioned to address the need for improved therapies to mitigate clinical rebound and long COVID risks [19]