NEWTOWN, Pa., Oct. 06, 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 appointment of John Leaman, MD, to its board of directors as an independent director, effective October 1, 2025. In addition, Traws’ Board of Directors (the “Board”) has eliminated the interim notation of its key executi ...

Core Viewpoint - Traws Pharma is advancing the development of ratutrelvir, a ritonavir-free treatment for COVID-19, through two Phase 2 trials aimed at evaluating its safety and efficacy compared to PAXLOVID®, with top-line data expected by the end of 2025 [1][2][3]. Group 1: Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 and Long COVID [6]. - The company integrates antiviral drug development with medical intelligence and regulatory strategy to address challenges in treating viral diseases [6]. Group 2: Product Development - Ratutrelvir is an investigational oral small molecule Mpro (3CL protease) inhibitor designed to treat SARS-CoV-2 without the need for ritonavir, potentially avoiding drug-drug interactions [3]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains target blood plasma levels significantly above the effective concentration, which may reduce the likelihood of clinical rebound and Long COVID [3]. Group 3: Market Context - In Q2 2025, Pfizer reported $427 million in sales for PAXLOVID®, marking a 70% increase from the same period the previous year, highlighting the ongoing demand for effective COVID-19 treatments [2]. - The rapid emergence of new viral variants, such as NB.1.8.1, which now accounts for 40% of COVID cases, underscores the need for effective antiviral therapies [2]. Group 4: Clinical Trials - The first trial will compare ratutrelvir against PAXLOVID® in newly diagnosed COVID patients, while a second trial will focus on PAXLOVID®-ineligible patients, a vulnerable group with limited treatment options [1][2]. - Results from both Phase 2 studies are anticipated by the end of 2025, which could provide critical proof-of-concept data for ratutrelvir [2].

Core Insights - Traws Pharma is advancing its antiviral programs targeting respiratory viruses, particularly focusing on ratutrelvir for COVID-19 and Tivoxavir marboxil (TXM) for influenza, in response to ongoing health threats and the need for effective treatments [1][20] - The company has submitted a Phase 2 study for ratutrelvir to evaluate its efficacy against PAXLOVID in newly diagnosed COVID patients, with results expected by the end of 2025 [3][5] - TXM is being positioned for stockpiling readiness, with ongoing discussions with BARDA for inclusion in pandemic preparedness initiatives [2][5] Product Development - Ratutrelvir is a ritonavir-free oral protease inhibitor designed for once-daily dosing over 10 days, showing promising Phase 1 results with plasma drug levels maintained significantly above the effective concentration [5][15] - TXM is an investigational single-dose treatment for bird flu and seasonal influenza, demonstrating strong preclinical efficacy against H5N1 and good tolerability in animal models [5][16] - The U.S. market opportunity for both products is estimated to be multi-billion dollars, driven by the ongoing need for effective antiviral treatments [5][15][16] Financial Performance - For Q2 2025, Traws reported revenue of $2.7 million, a significant increase from $57,000 in the same period in 2024, primarily due to deferred revenue recognition from a terminated licensing agreement [11][27] - Research and development expenses decreased to $2.3 million from $4.0 million year-over-year, reflecting a strategic shift in focus towards virology programs [12][13] - The net loss for Q2 2025 was $0.9 million, a substantial improvement compared to a net loss of $123.1 million in Q2 2024, which included a one-time charge related to an acquisition [13][29] Management and Corporate Updates - Traws will host a business update call on August 14, 2025, to discuss its Q2 results and pipeline progress [8] - Recent management changes include the appointment of Jack Stover as Chairman of the Board and Charles Parker as Interim CFO [13][21] - The company is actively seeking partnerships for its legacy oncology programs, including rigosertib and narazaciclib, to support further development [21]

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 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]

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 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]