Completed clinical results with ratutrelvir confirm a differentiated profile versus PAXLOVID® with fewer adverse events and no viral rebounds with equivalent time to sustained symptom resolution; results were recapitulated in PAXLOVID®-ineligible patients, representing a significant population with no effective treatment options Pre-clinical analysis of tivoxavir marboxil tablets demonstrated significantly increased exposure compared to a prototype formulation with predicted 28-day protection in humans from ...

Core Insights - Traws Pharma's ongoing clinical results with ratutrelvir indicate a differentiated profile compared to PAXLOVID, showing fewer adverse events, no viral rebounds to date, and faster time to sustained symptom resolution, particularly in PAXLOVID-ineligible patients [1][4][9] - The company is also advancing tivoxavir marboxil, which is predicted to provide 28-day protection against a wide range of seasonal and pandemic influenza variants [1][5][6] Ratutrelvir Update - The Phase 2 study of ratutrelvir is an active-controlled trial against PAXLOVID, focusing on patient-reported outcomes, safety, and usability [2] - Patients in the ratutrelvir arm received 600 mg orally once daily for 10 days, while the comparator arm received PAXLOVID as per approved guidelines [3] - The data suggests ratutrelvir may benefit a broader range of patients, especially those unable to receive ritonavir-boosted therapy, with a favorable tolerability profile and absence of viral rebound events [4] Tivoxavir Marboxil Update - Traws Pharma is progressing tivoxavir marboxil as a single monthly oral tablet for prophylactic treatment of seasonal influenza [5] - Previous Phase 1 studies indicated that a powder-in-capsule formulation provided blood levels exceeding 3X the EC50 for common seasonal influenza variants for up to 22 days [6] - A new compressed tablet formulation is expected to provide 28-day coverage, with a challenge study planned for June 2026 [7] Market Opportunity - The COVID treatment market represents a potential multi-billion dollar opportunity, with ratutrelvir targeting the Main protease (Mpro) of SARS-CoV-2 [9] - Seasonal influenza also represents a significant multi-billion dollar market opportunity, driven by global health organizations and potential pandemic flu outbreaks [10]

Core Insights - Traws Pharma has filed a U.S. IND application for tivoxavir marboxil (TXM), a potential treatment for influenza, marking a significant step towards its inclusion in the strategic national stockpile [1][3][4] - Updated clinical results for ratutrelvir indicate a favorable profile compared to PAXLOVID, with fewer adverse events, no viral rebounds, and quicker symptom resolution, particularly in patients ineligible for PAXLOVID [1][5][8] Company Developments - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for respiratory viral diseases, including COVID-19 and influenza [18] - The company is advancing ratutrelvir as a ritonavir-independent treatment for COVID-19, targeting the Main protease (Mpro or 3CL protease) [18] - Traws Pharma is also developing tivoxavir marboxil as a single-dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease [18] Clinical Study Insights - The ongoing Phase 2 study of ratutrelvir has enrolled 50 patients, with 95% of the planned 90-patient population already enrolled [6] - Interim analysis shows that ratutrelvir-treated patients had a time to sustained symptom resolution of 12 days compared to 14 days for PAXLOVID-treated patients (p<0.014) [8][9] - Ratutrelvir demonstrated a better safety profile, with only 7.6% of patients reporting mild dyspepsia, while 30% of PAXLOVID patients reported adverse events [11][12] Market Potential - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government initiatives [15] - The COVID-19 treatment market also presents significant potential, with ratutrelvir positioned as a next-generation oral 3CL protease inhibitor [14][15]

Core Viewpoint - Ratutrelvir demonstrates a differentiated clinical profile compared to PAXLOVID™, showing fewer adverse events and no viral rebounds, making it a promising treatment option for patients with mild-to-moderate COVID-19, including those ineligible for ritonavir-boosted therapies [1][5][12]. Group 1: Clinical Study Overview - Traws Pharma announced interim data from a Phase 2 clinical study of ratutrelvir, an oral, ritonavir-free protease inhibitor, which showed a favorable clinical profile in patients with mild-to-moderate COVID-19 [2][3]. - The study is an active-controlled trial comparing ratutrelvir to PAXLOVID™, with 37 patients included in the interim analysis, of which 25 received ratutrelvir and 12 received PAXLOVID™ [3][4]. - More than 50% of the planned 90-patient population has been enrolled in the study [3]. Group 2: Efficacy and Safety - Ratutrelvir-treated patients showed comparable time-to-sustained symptom alleviation to those treated with PAXLOVID™, with sustained alleviation defined as self-reported alleviation of all COVID-19 symptoms for four consecutive days [6]. - No COVID-19 symptom or virologic rebound events were observed in ratutrelvir-treated patients, while one rebound event occurred in the PAXLOVID™ group [7]. - Ratutrelvir was well tolerated, with fewer adverse events reported compared to the PAXLOVID™ cohort, where 30% of patients experienced adverse events [9][10]. Group 3: Implications for Long-COVID - The combination of early and sustained symptom improvement, absence of viral rebound, and favorable tolerability suggests that ratutrelvir may be useful in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID) [12]. - Ratutrelvir's design allows for broader patient use without the limitations associated with ritonavir, potentially offering a new approach to both acute COVID-19 treatment and prevention of long-term complications [12][13]. Group 4: Market Potential - The COVID treatment market represents a potential multi-billion dollar opportunity, with ratutrelvir positioned as a next-generation oral 3CL protease inhibitor that is ritonavir-free and has an improved tolerability profile [14].

Core Insights - ChemDiv announced an extension of its Chemistry, Manufacturing and Controls (CMC) services collaboration to support the clinical development of ratutrelvir, an oral antiviral treatment for COVID-19, following Traws Pharma's initiation of Phase 2 studies [1][3] - Ratutrelvir is a ritonavir-free Main protease inhibitor, designed to offer high potency against various SARS-CoV-2 strains, with a simplified 10-day treatment regimen [2][4] - The ongoing collaboration between ChemDiv, Traws Pharma, and Expert Systems aims to enhance the clinical development of ratutrelvir through advanced predictive safety pharmacology [3][5] Company Overview - ChemDiv is a global provider of integrated drug discovery solutions, offering a wide range of services including medicinal chemistry, CMC, and AI-powered drug design [9] - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel antiviral therapies for respiratory viral diseases, including ratutrelvir for COVID-19 [8] - Expert Systems is an advanced AI-based platform that supports drug discovery and development, contributing to the predictive pharmacology of ratutrelvir [5] Clinical Development - Ratutrelvir is currently being evaluated in two Phase 2 studies: one comparing it to PAXLOVID® in newly diagnosed patients and another for PAXLOVID®-ineligible patients [3][4] - Phase 1 studies indicated that ratutrelvir maintained plasma levels approximately 13 times above the effective concentration with a once-daily dosing regimen, potentially reducing the risk of viral rebound and Long COVID [3]

Core Insights - Traws Pharma is conducting a Phase 2 study to evaluate ratutrelvir, a ritonavir-free antiviral treatment for COVID-19, with top-line data expected by year-end 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 [5] - The company aims to address critical health threats, including COVID-19, Long COVID, bird flu, and seasonal influenza [5] Group 2: Product Development - Ratutrelvir is designed as an oral, small molecule Mpro (3CL protease) inhibitor, showing in vitro activity against various virus strains [3] - The treatment does not require co-administration with ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [3] - Phase 1 studies indicate that ratutrelvir maintains target blood plasma levels approximately 13 times above the EC50, which may reduce the likelihood of clinical rebound and Long COVID risk [3] Group 3: Clinical Trials - The first trial compares ratutrelvir against PAXLOVID, evaluating safety, infection rates, COVID symptoms, disease rebound, and Long COVID incidence [2] - A second trial will assess ratutrelvir's safety and efficacy in PAXLOVID-ineligible patients, a vulnerable population with limited treatment options [2] - Results from both Phase 2 studies are anticipated by the end of 2025 [2] Group 4: Market Potential - The COVID treatment market represents a potential multi-billion dollar opportunity, highlighting the significance of effective antiviral therapies [3]

Core Insights - Traws Pharma, Inc. has appointed Dr. John Leaman as an independent director to its board, effective October 1, 2025, and has removed the interim titles of its key executives, indicating strong board support for the leadership team [1][2][6] Company Developments - Dr. Leaman brings over a decade of experience in finance, M&A, and corporate strategy, which is expected to be valuable as the company prepares for Phase 2 studies of its lead product, ratutrelvir, aimed at treating COVID-19 [2][3] - The removal of interim titles for CEO Iain Dukes and CFO Charles Parker signifies the board's confidence in their leadership [1][2] Product Pipeline - Ratutrelvir is an investigational oral small molecule designed to treat SARS-CoV-2/COVID-19 without the need for ritonavir, showing promising preclinical and Phase 1 study results [7] - The pharmacokinetic profile of ratutrelvir indicates maintenance of target blood plasma levels approximately 13 times above the EC50 with a dosing regimen of 600 mg/day for ten days, potentially reducing the risk of Long COVID [7] - Tivoxavir marboxil (TXM) is another investigational product targeting bird flu and seasonal influenza, demonstrating potent in vitro activity against various influenza strains [8][9] Market Opportunity - The COVID treatment market represents a potential multi-billion dollar opportunity, driven by ongoing health challenges and the need for effective antiviral therapies [7] - Seasonal influenza and bird flu treatments also present significant market potential, supported by global health initiatives and government tenders [8][9]

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]