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]

Core Viewpoint - Traws Pharma, Inc. has presented positive data supporting the potential of tivoxavir marboxil (TXM) as a treatment for bird flu at the International Society for Antiviral Research (ICAR 2025) conference, indicating its effectiveness and safety profile [1][2]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including bird flu and seasonal influenza [8][9]. - The company aims to create investigational antiviral agents that are potent against difficult-to-treat or resistant virus strains, with a commitment to patient safety and simple dosing regimens [8]. Product Development - Tivoxavir marboxil (TXM) is an investigational oral small molecule designed as a single-dose treatment targeting the influenza cap-dependent endonuclease (CEN) [9]. - The data presented at ICAR highlighted that TXM demonstrated 100% survival in a rodent challenge model against H5N1 bird flu, with significant reductions in lung viremia and no virus-induced weight loss [6][5]. - Laboratory studies showed TXM's potent suppression of influenza A, B, and C viruses, including those resistant to baloxavir, with sub-nanomolar potency against H5N1 [6]. Clinical Trials and Regulatory Plans - Phase 1 trial results indicated that a single dose of TXM maintained plasma blood levels at EC90 for approximately three weeks, demonstrating good overall tolerability [6]. - The company plans to meet with the FDA to discuss next steps, including the potential for an accelerated path to approval for TXM [2]. Market Opportunity - Seasonal influenza represents a significant multi-billion dollar antiviral market opportunity, driven by global health organizations and government tenders, with additional potential from pandemic flu outbreaks like H5N1 [7].