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]

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]

Investor Event March 31, 2025 Targeting Critical Threats to Human Health Forward-looking statements This presentation contains, and certain oral statements made by management from time to time may contain, "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include ...

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]