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Traws Pharma Reports Second Quarter 2025 Results and Business Highlights
Globenewswire· 2025-08-14 11:00
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]
Cocrystal Pharma's Novel Norovirus Antiviral to be Presented at Department of Defense Medical Conference
GlobeNewswire News Room· 2025-06-05 12:00
Core Viewpoint - Cocrystal Pharma, Inc. is presenting its broad-spectrum protease inhibitor CDI-988 at the 2025 Military Health System Research Symposium, highlighting its potential as a prophylaxis and treatment for norovirus, which currently lacks approved antiviral agents or vaccines [1][2]. Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel antiviral therapeutics targeting the replication processes of various viruses, including noroviruses, coronaviruses, and hepatitis C viruses [6]. - The company utilizes unique structure-based technologies and expertise in enzymology and medicinal chemistry to create first- and best-in-class antiviral drugs [6]. Product Development - CDI-988 is designed as a broad-spectrum inhibitor targeting a highly conserved region in the active site of 3CL viral proteases, representing a first-in-class oral treatment for noroviruses and coronaviruses [3]. - The company has completed a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of CDI-988 in healthy adults, which included a food effect cohort [3]. Technology Platform - Cocrystal's proprietary structure-based platform technology provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, facilitating the identification of novel binding sites and rapid structural information processing [4]. - The goal of this technology is to develop antiviral therapies that are safe, well-tolerated, and effective against all viral subtypes, with a high barrier to viral resistance [4]. Industry Context - The Military Health System Research Symposium is an annual event that gathers military medical care providers, researchers, and industry representatives to discuss healthcare initiatives related to military infectious diseases and operational medicine [5].
Cocrystal Pharma’s Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants
Globenewswire· 2025-04-24 12:00
Core Insights - Cocrystal Pharma's investigational drug candidate CDI-988 demonstrates strong binding to the GII.17 protease, showing excellent potency against norovirus variants, particularly GII.4 and GII.17 strains [1][6] - The company plans to initiate a human norovirus challenge study in 2025 to evaluate CDI-988 for prevention and treatment of norovirus infections [1][6] Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on developing novel antiviral therapeutics targeting noroviruses, influenza viruses, coronaviruses, and hepatitis C viruses [5] - The company utilizes unique structure-based technologies and expertise in enzymology and medicinal chemistry to create first- and best-in-class antiviral drugs [5] Product Development - CDI-988 is a pan-viral protease inhibitor designed for broad-spectrum antiviral activity, targeting a highly conserved region in 3CL viral proteases [3] - A Phase 1 study has been completed, showing favorable safety and tolerability for CDI-988 in healthy adults [3][6] Technological Innovation - Cocrystal's proprietary structure-based platform technology provides near-atomic resolution insights into inhibitor complexes, facilitating rapid development of effective antiviral therapies [4] - The technology aims to identify novel binding sites and ensure a high barrier to viral resistance, enhancing the efficacy of antiviral treatments [4] Market Context - Norovirus is the leading cause of acute gastroenteritis globally, with an estimated 685 million cases and approximately 50,000 child deaths annually, resulting in a societal cost of around $60 billion [2] - The emergence of GII.17 variants has led to increased norovirus outbreaks, highlighting the urgent need for effective antiviral treatments [6]
Traws Pharma Reports Full Year 2024 Results and Business Highlights
Globenewswire· 2025-03-31 13:00
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]
Traws Pharma Reports Full Year 2024 Results and Business Highlights
Newsfilter· 2025-03-31 13:00
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]
Traws Pharma to Host Investor Event on Bird Flu and COVID Product Candidates Virtual Event to be Held on Monday, March 31, 2025 at 10:00 AM ET
Newsfilter· 2025-03-26 11:30
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].
Traws Pharma to Host Investor Event on Bird Flu and COVID Product Candidates Virtual Event to be Held on Monday, March 31, 2025 at 10:00 AM ET
GlobeNewswire News Room· 2025-03-26 11:30
Core Insights - Traws Pharma is hosting a virtual investor event on March 31, 2025, to discuss its investigational oral small molecule product candidates targeting respiratory viral diseases [1][2] - The event will feature key management personnel, including Robert R. Redfield, MD, and C. David Pauza, PhD, who will present data and engage in a Q&A session [2] Traws Pharma Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases [9][10] - The company is advancing investigational antiviral agents with potent activity against resistant virus strains, aiming for safe and simple dosing regimens [9] Product Candidates Tivoxavir Marboxil - Tivoxavir marboxil (TXM) is an investigational oral small molecule designed as a single-dose treatment for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains, including H5N1 [3][10] - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and potential pandemic outbreaks [3] Ratutrelvir - Ratutrelvir is an investigational oral small molecule Mpro inhibitor for COVID-19, designed to be used without ritonavir, thus avoiding associated drug-drug interactions [4][10] - Preclinical and Phase 1 studies indicate that ratutrelvir maintains target blood plasma levels significantly above the EC50, potentially reducing the risk of clinical rebound and long COVID [4] Market Opportunities - The COVID-19 treatment market represents a potential multi-billion dollar opportunity, highlighting the ongoing need for improved therapies [4][10]