Werner Cautreels, PhD, to retire as CEO, while continuing as a Board MemberIain D. Dukes, D Phil, Executive Board Chairman, to become Interim CEO NEWTOWN, Pa., March 28, 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 health from respiratory viral diseases, today announced the retirement of Werner Cautreels, PhD, Chief Executive Officer (CEO), effec ...

Core Viewpoint - Traws Pharma is hosting a virtual investor event to discuss its investigational oral small molecule product candidates targeting respiratory viral diseases, specifically focusing on Tivoxavir marboxil for bird flu and Ratutrelvir for COVID-19 [1][2]. Group 1: Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for critical threats to human health from respiratory viral diseases [9]. - The company is advancing investigational antiviral agents that exhibit potent activity against difficult-to-treat or resistant virus strains [9]. - Traws Pharma aims to utilize accelerated clinical trial strategies with a commitment to vulnerable patient populations [9]. Group 2: Product Candidates - Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed for single-dose treatment of bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains, including H5N1 [3][10]. - 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 [3]. - Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor for COVID-19, designed to be used without ritonavir, demonstrating in vitro activity against multiple COVID-19 strains [4][10]. - Phase 1 studies indicate that Ratutrelvir maintains target blood plasma levels approximately 13 times above the EC50, potentially reducing the risk of clinical rebound and long COVID [4][10]. Group 3: Market Opportunities - The COVID-19 treatment market represents a potential multi-billion dollar opportunity, highlighting the ongoing need for improved therapies [4][10]. - The significant public health risk posed by H5N1 bird flu underscores the importance of developing effective treatments, as indicated by Traws' preclinical proof-of-concept and Phase 1 studies [7].

Event to highlight the differentiated features of Traws oral small molecule product candidates: Tivoxavir Marboxil, a single dose, CAP-dependent endonuclease inhibitor for Bird FluRatutrelvir, a main protease inhibitor, to be used without ritonavir, for COVID-19 NEWTON, Pa., March 26, 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 health from respi ...

Core Viewpoint - Traws Pharma, Inc. has presented positive data for ratutrelvir, a main protease inhibitor, as a potential treatment for COVID-19, highlighting its advantages over current therapies, particularly the lack of need for co-administration with ritonavir [1][2][4]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 [9][10]. - The company aims to create safe antiviral agents with simple dosing regimens to address critical health threats [9]. Product Development - Ratutrelvir is designed to be an oral, small molecule Mpro (3CL protease) inhibitor that can be used without ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [7][10]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains therapeutic blood levels significantly above the effective concentration (EC50) and does not require a metabolism inhibitor [5][7]. Clinical Data - Data from Phase 1 studies demonstrate excellent safety and tolerability for ratutrelvir, with a selected Phase 2 dosing regimen of 600 mg/day for 10 days showing promising pharmacokinetics [6][7]. - Laboratory studies confirm that ratutrelvir effectively suppresses replication of various SARS-CoV-2 strains, including Omicron variants, and maintains blood plasma levels above the EC90 [5][6]. Future Plans - Traws Pharma is preparing to engage with the FDA to discuss the path forward for ratutrelvir and plans to initiate Phase 2 studies [4][6]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on ratutrelvir [4][6].

Core Viewpoint - Traws Pharma, Inc. has presented positive data for ratutrelvir, a main protease inhibitor, as a potential treatment for COVID-19, highlighting its advantages over current therapies, particularly the lack of need for co-administration with ritonavir [1][2][4]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 [9][10]. - The company aims to create safe antiviral agents with simple dosing regimens and is committed to accelerated clinical trial strategies [9]. Product Development - Ratutrelvir is designed to be an oral, small molecule Mpro inhibitor that can be used without ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [7][10]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains blood plasma levels approximately 13 times above the EC50, which may reduce the likelihood of clinical rebound and long COVID [7][6]. Clinical Data - Data presented at the International Conference for Antiviral Research (ICAR 2025) demonstrated that ratutrelvir effectively suppressed replication of 18 different SARS-CoV-2 strains, including Omicron variants [2][5]. - Phase 1 results showed excellent safety and tolerability, with a selected Phase 2 dosing regimen of 600 mg/day for 10 days [3][6]. Future Plans - The company is preparing to engage with the FDA to discuss the path forward for ratutrelvir and plans to initiate Phase 2 studies [4][2]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on ratutrelvir [4][2].

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].

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 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].

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]