Core Viewpoint - Traws Pharma announced positive topline results from a study of tivoxavir marboxil (TXM) as a treatment for H5N1 bird flu in non-human primates, indicating its potential as a novel therapy for respiratory viral diseases [1][3][4]. Group 1: Study Results - The study involved ten non-human primates, with TXM administered as a single dose equivalent to 480 mg for humans, showing significant reduction in lung viremia and prevention of weight loss [2][5]. - TXM-treated animals had lung viremia levels consistently below the quantitation limit of 2X10^3 infectious particles per ml, while control animals reached levels as high as 1X10^7 infectious particles per ml [5]. - Control animals lost an average of 4.2% of their body weight over ten days post-challenge, whereas TXM-treated animals maintained stable or slightly increased body weight (p<0.004) [5]. Group 2: Regulatory Path and Future Plans - The company plans to meet with the FDA in the first half of 2025 to discuss the regulatory path for TXM, including the potential for accelerated approval under the "Animal Rule" [3][4]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on TXM and discuss next steps towards approval [4][5]. Group 3: Broader Implications - The ongoing threat of bird flu, particularly with reports of mutations increasing pandemic risk, underscores the importance of developing effective antiviral treatments like TXM [3][6]. - TXM has shown consistent therapeutic effects across multiple animal models, including ferrets and mice, reinforcing its potential as a treatment for both bird flu and seasonal influenza [5][6][12].

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].

Poster underscores Tivoxavir Marboxil’s potential for the treatment of bird flu, supported by 100% survival in a rodent challenge model, potent suppression of resistant viruses and Phase 1 dataFull dataset to be highlighted during Investor Call on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human h ...

Core Insights - Traws Pharma announced positive topline results from studies on tivoxavir marboxil, showing its efficacy in treating H5N1 bird flu in ferrets, consistent with previous murine model results [1][2][3] - The company is conducting further studies in non-human primates, with data expected in Q1 2025, and plans to approach the FDA for accelerated approval under the "Animal Rule" [2][3] Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases, including bird flu and seasonal influenza [6] - The company is developing two drug candidates: tivoxavir marboxil for bird flu and seasonal influenza, and ratutrelvir for COVID-19 treatment [6] Product Details - Tivoxavir marboxil is designed to inhibit the influenza protein CAP-dependent endonuclease (CEN) and has shown potent in vitro activity against various influenza strains, including H5N1 [5] - The antiviral market for bird flu and seasonal influenza is estimated to represent a multi-billion dollar opportunity, driven by global health organizations and government tenders [5]

Core Insights - Traws Pharma has regained compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million, allowing its common stock to continue trading on The NASDAQ Capital Market under the symbol "TRAW" [1][3] - The company is advancing its pipeline of investigational antivirals, particularly focusing on bird flu and influenza, with a recent successful Phase 1 trial [2][4] - Traws Pharma raised $20 million in gross proceeds through a successful offering, strengthening its financial position [3] Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company developing oral small molecule therapies for respiratory viral diseases, including two novel drug candidates: tivoxavir marboxil for bird/pandemic flu and seasonal flu, and ratutrelvir for COVID-19 [4][5] - The company aims to address unmet medical needs using advanced drug development technology, focusing on product safety and solutions for vulnerable patient populations [5]

Core Viewpoint - Traws Pharma has completed Phase I clinical studies for its investigational one-dose influenza therapy, tivoxavir marboxil, aimed at treating or preventing H5N1 bird flu, with pharmacokinetic data supporting further development [1][2][3]. Group 1: Clinical Development - The Phase I trial was a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of tivoxavir marboxil in healthy adult volunteers [4]. - Topline results indicated no significant treatment-related adverse events during the study, which evaluated four dose levels [5]. - The clinical data supports accelerated development of tivoxavir marboxil in response to the increasing threat of bird flu [2][3]. Group 2: Market Opportunity - Seasonal influenza represents a multi-billion dollar antiviral market opportunity, driven by global health organizations and government tenders, with potential upside from pandemic flu outbreaks [6]. - Tivoxavir marboxil is designed to inhibit the highly conserved influenza protein, CAP-dependent endonuclease (CEN), and has shown potent in vitro activity against various influenza strains, including H5N1 [6]. Group 3: Future Directions - Ongoing animal model studies are assessing the impact of a single dose of tivoxavir marboxil on lethal bird flu infection, supporting its further development as a one-time treatment for bird flu [6]. - The combined clinical and animal model data will guide upcoming regulatory meetings as the company advances this product [3].

Core Insights - Expert Systems and Traws Pharma have achieved a significant milestone in the development of Tivoxavir Marboxil, an antiviral drug targeting H5N1 avian influenza, which shows promise as a single-dose treatment [1][2][5] Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases and cancer, utilizing expertise in small molecule chemistry and artificial intelligence [6] - Expert Systems is a leader in drug discovery and development, combining advanced machine learning algorithms with domain expertise to accelerate the development of innovative therapies for critical medical needs [7] Drug Development Progress - Tivoxavir Marboxil has demonstrated broad-spectrum efficacy against various flu strains, including drug-resistant and highly pathogenic avian influenza viruses, in preclinical studies [2] - A Phase 1 clinical trial showed that a single dose of Tivoxavir Marboxil maintained plasma drug levels above the effective concentration for over 23 days, indicating potential for sustained efficacy [3] - Following the successful completion of Phase 1 trials, plans are in place to initiate Phase 2 efficacy studies in the first half of 2025, moving closer to market availability [5] Expert Commentary - Dr. Robert R. Redfield, Chief Medical Officer of Traws Pharma, highlighted the increasing risk of avian influenza adapting to humans, emphasizing the need for vigilance against potential epidemic or pandemic spread [4] - Tudor Oprea, CEO of Expert Systems, noted the transformative potential of combining artificial intelligence with human expertise to address urgent global health challenges [5]

Group 1 - Traws Pharma, Inc. has announced a financing agreement to raise up to $72.6 million, which includes an initial tranche of $20 million and a subsequent tranche of up to $52.6 million, aimed at extending its cash runway into the first half of 2026 and beyond [1][2] - The financing will support the development of Tivoxavir Marboxil, a drug candidate designed to treat respiratory viral diseases, including bird flu, with significant potential in the antiviral market [2][9] - The initial tranche will be funded through the issuance of 3,919,249 shares of common stock and pre-paid warrants, with additional funds available upon the exercise of non-prepaid warrants [1] Group 2 - The company is expecting key data readouts in early 2025 related to Ferret Bird Flu and Non-Human Primate Bird Flu, as well as Phase 2A data anticipated in the second half of 2025 [1] - Traws Pharma has received support from notable institutional investors, indicating strong confidence in the company's potential and the transformative nature of this financing [2] - The company plans to host an update call regarding Tivoxavir Marboxil in the first quarter of 2025, providing further insights into its development [14] Group 3 - The H5N1 bird flu virus has been confirmed in at least 866 herds across 16 states in the U.S., with over 60 human infections reported, highlighting the urgency for effective treatments [8][13] - Tivoxavir Marboxil has shown potent in vitro activity against various influenza strains, including highly pathogenic avian flu, and may enable a single-dose prophylaxis regimen [9][13] - The financing and ongoing development efforts are crucial as health officials warn of the rising potential for epidemic or pandemic spread of bird flu [13]

Core Insights - Traws Pharma is developing tivoxavir marboxil as a potential treatment for H5N1 bird flu, demonstrating safety and tolerability in Phase 1 trials, with drug levels maintained above the effective concentration for over 23 days [3][5][15] - The company plans to initiate a Phase 2 study in the first half of 2025, responding to the increasing risk of avian influenza adapting to humans [4][10] - The emergence of H5N1 in U.S. dairy cattle has raised concerns, with over 60 human infections reported, highlighting the urgency for effective treatments [10] Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases, including influenza and COVID-19 [11] - The company is committed to addressing unmet medical needs through innovative drug development technologies [11] Product Development - Tivoxavir marboxil has shown potent inhibition of drug-resistant influenza viruses and highly pathogenic avian flu viruses in both in vitro and in vivo studies [5][15] - The drug's pharmacokinetic profile supports the potential for a single-dose treatment regimen, which could be significant for pandemic preparedness [15] Market Opportunity - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health initiatives and government tenders, with additional potential from pandemic flu scenarios [6]

Financial Performance - The Company reported net losses of $136.6 million for the nine months ended September 30, 2024, compared to $14.8 million for the same period in 2023, resulting in an accumulated deficit of $619.2 million as of September 30, 2024[97]. - Revenues for the three months ended September 30, 2024 were $57,000, consistent with the same period in 2023[139]. - Total operating expenses for the nine months ended September 30, 2024 were $137.3 million, significantly higher than $16.0 million in the same period of 2023[146]. - The Company incurred transaction costs of approximately $8.7 million related to the planned Merger during the nine months ended September 30, 2024[131]. - Net cash used in operating activities was $25.8 million for the nine months ended September 30, 2024, primarily due to a net loss of $136.6 million and a $7.7 million change in operating assets and liabilities[156]. - Significant non-cash charges of $118.5 million were recorded, mainly from the immediate expensing of in-process research and development related to the acquisition of Trawsfynydd, totaling $117.5 million[156]. - The company has not achieved profitability since inception and expects to continue incurring net losses for the foreseeable future[160]. - Projected net cash expenditures in 2024 are expected to be higher than in 2023 due to advancements in clinical trials and significant transaction-related costs associated with the Merger[160]. Cash Position and Funding - As of September 30, 2024, the Company had $5.4 million in cash and cash equivalents and raised gross proceeds of $14 million through a Securities Purchase Agreement on April 1, 2024[98]. - The company believes its cash and cash equivalents will fund ongoing trials and operations into the first quarter of 2025, but raises substantial doubt about its ability to continue as a going concern beyond that period[160]. - The Company is exploring various sources of funding for development and ongoing operations, with substantial doubt regarding its ability to continue as a going concern[98][99]. - The Company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[152]. - Net cash provided by financing activities was $14.0 million for the nine months ended September 30, 2024, from the private placement of Common Stock[159]. Clinical Development - TRX100, a small molecule cap-dependent endonuclease inhibitor, is being developed for the treatment and prophylaxis of seasonal influenza and bird flu[100]. - The Phase 1 clinical study of TRX100 showed good overall tolerability, with a single dose maintaining plasma drug levels above the EC90 for more than 20 days[104]. - TRX01, an inhibitor of the main protease of the SARS-CoV-2 virus, demonstrated inhibition of viral replication in preclinical studies and is planned for further development[105]. - The Phase 1 trial of TRX01 included 40 participants and showed no treatment-related adverse events, with plasma drug levels maintained within the therapeutic window for 12 days[106]. - The Company plans to initiate a Phase 2 study for both TRX100 and TRX01 in the first half of 2025[104][106]. - Narazaciclib is being evaluated in a multi-center Phase 1/2a trial for recurrent metastatic low-grade endometrioid endometrial cancer, with approximately 30 patients expected to enroll in the Phase 2 expansion cohort[107]. - A Phase 1 study of narazaciclib as a monotherapy is ongoing to assess safety and tolerability in patients with relapsed and/or refractory advanced cancer[108]. - The company plans to initiate two investigator-initiated studies in the USA for narazaciclib, targeting patients with refractory breast cancer and multiple myeloma[109]. - Rigosertib is being studied for epidermolysis bullosa-associated squamous cell carcinoma, with the company pursuing orphan drug designation from the FDA[111]. Corporate Actions - On April 1, 2024, the company completed a merger with Trawsfynydd Therapeutics, issuing 141,982 shares of Common Stock and 10,359.0916 shares of Series C[117]. - The merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes[116]. - The company raised approximately $14 million through a private placement, issuing 19,879 shares of Common Stock and 1,578.2120 shares of Series C[125]. - The company has filed a registration statement with the SEC for the resale of shares related to the merger, which was declared effective on August 28, 2024[126]. - A reverse stock split of one-for-25 was approved by the Board in September 2024, retroactively adjusting all related share information[113]. - The company regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at least $1.00 per share for ten consecutive business days[114]. - The Company was notified of non-compliance with Nasdaq's minimum stockholders' equity requirement and attended a hearing to present its compliance plan[153]. Operational Challenges - The Company expects to incur significant expenses and operating losses for the foreseeable future as it continues the development of its product candidates[97]. - There is currently no organization for sales, marketing, and distribution of pharmaceutical products, and the company may rely on licensing and co-promotion agreements for commercialization[161]. - Additional costs are expected to be incurred associated with operating as a public company and fulfilling obligations under the Merger Agreement and related agreements[161].