Antiviral drug development
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Cocrystal Pharma Reports 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
Globenewswire· 2026-03-31 12:00
Core Viewpoint - Cocrystal Pharma is advancing its antiviral product pipeline, particularly focusing on CDI-988, an oral antiviral candidate for norovirus treatment and prevention, amidst a significant unmet medical need in the market [1][7][18]. Antiviral Product Pipeline Overview - The company utilizes a structure-based drug discovery platform to develop broad-spectrum antivirals that target conserved regions of viral proteins, enhancing efficacy against mutations and reducing side effects [4]. - CDI-988 is designed as a direct-acting oral antiviral targeting the 3CL protease of noroviruses and has potential applications against coronaviruses [3][15]. Norovirus Program - Norovirus causes approximately 685 million cases globally each year, with a $60 billion economic impact, highlighting the urgent need for effective treatments [6]. - CDI-988 is currently undergoing a Phase 1b challenge study at Emory University, with the primary endpoint focused on reducing clinical symptoms [2][7]. Financial Results - For the year ended December 31, 2025, Cocrystal reported a net loss of $8.8 million, a significant reduction from the $17.5 million loss in 2024, indicating improved financial management [17]. - Research and development expenses decreased to $5.1 million in 2025 from $12.5 million in 2024, primarily due to the winding down of previous studies [16]. Influenza Programs - The company is also developing CC-42344, a novel PB2 inhibitor for influenza, which has shown in vitro activity against resistant strains [11][13]. - Influenza poses a major health threat with approximately 1 billion cases annually, leading to significant healthcare costs [10]. Market Potential - The global market for COVID-19 therapeutics is projected to exceed $16 billion annually by the end of 2031, indicating substantial growth opportunities for antiviral treatments [14].
Atea Pharmaceuticals(AVIR) - 2025 Q4 - Earnings Call Presentation
2026-03-05 21:30
Q4 and Full Year 2025 Financial and Business Update March 5, 2026 Disclaimers Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our preclinical study and clinical tr ...
Atea Pharmaceuticals to Present at the 8th Annual Evercore Healthcare Conference
Globenewswire· 2025-11-19 12:00
Core Insights - Atea Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing oral antiviral therapeutics for serious viral diseases [3] Company Overview - Atea specializes in discovering, developing, and commercializing oral antiviral therapies to meet the unmet medical needs of patients with serious viral infections [3] - The company has developed a proprietary nucleos(t)ide prodrug platform aimed at treating single-stranded ribonucleic acid (ssRNA) viruses, which are a significant cause of serious viral diseases [3] - Atea's lead program includes bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, specifically targeting Hepatitis C Virus (HCV) [3] Upcoming Events - Jean-Pierre Sommadossi, PhD, CEO and Founder of Atea, along with the management team, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on December 3, 2025, at 10:00 a.m. ET in Coral Gables, FL [1] - A live webcast of the presentation will be available on Atea's website, with an archived version accessible for at least 90 days post-event [2]
Cocrystal Pharma Reports Third Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
Globenewswire· 2025-11-14 13:00
Core Insights - Cocrystal Pharma, Inc. reported financial results for the three and nine months ended September 30, 2025, highlighting advancements in its antiviral product pipeline and financial position [1][14][16]. Financial Performance - Research and development (R&D) expenses for Q3 2025 were $954,000, a decrease from $3.2 million in Q3 2024, primarily due to the winding down of clinical study costs [14]. - General and administrative (G&A) expenses for Q3 2025 were $1.1 million, down from $1.8 million in Q3 2024, attributed to reduced compensation expenses [14]. - The net loss for Q3 2025 was $2.0 million, or $0.19 per share, compared to a net loss of $4.9 million, or $0.49 per share, in Q3 2024 [15]. - For the first nine months of 2025, R&D expenses totaled $3.4 million, down from $10.5 million in the same period of 2024, while G&A expenses were $3.1 million compared to $4.1 million [16]. - The net loss for the first nine months of 2025 was $6.4 million, or $0.61 per share, compared to a net loss of $14.2 million, or $1.40 per share, in the first nine months of 2024 [16]. - As of September 30, 2025, the company reported unrestricted cash of $7.7 million, down from $9.9 million at the end of 2024 [17]. Antiviral Product Pipeline - Cocrystal is advancing its antiviral product pipeline, including CDI-988, an oral broad-spectrum protease inhibitor targeting norovirus, with participant enrollment for a challenge study expected to begin in Q1 2026 [2][7]. - The company received a Small Business Innovation Research (SBIR) award from the NIH to support the development of a novel candidate targeting the influenza A/B polymerase complex [3][19]. - CDI-988 has shown in vitro activity against multiple norovirus strains and is being evaluated for both prevention and treatment of norovirus infections [11][20]. Norovirus Program - Norovirus causes approximately 685 million global cases annually, with a $60 billion economic impact, and is responsible for an estimated 21 million infections in the U.S. each year [6]. - The annual burden of norovirus in the U.S. is estimated at $10.6 billion, with significant hospitalization and mortality rates, particularly among children in developing countries [6]. Influenza Programs - Influenza poses a major global health threat, with approximately 1 billion cases reported annually and significant direct medical costs in the U.S. estimated at $10.4 billion [10]. - Cocrystal's CC-42344, a PB2 inhibitor, has shown promising in vitro activity against pandemic and seasonal influenza A strains, including those resistant to existing antivirals [12][19].
Cocrystal Pharma Reports Second Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
Globenewswire· 2025-08-14 12:00
Core Viewpoint - Cocrystal Pharma, Inc. is advancing its antiviral product pipeline, particularly focusing on CDI-988 for norovirus and CC-42344 for influenza, while reporting improved financial results for the second quarter and first half of 2025 [1][17][19]. Antiviral Product Pipeline Overview - CDI-988 is being prepared for a Phase 1b norovirus challenge study, showing favorable safety and tolerability results from previous studies [2][7]. - The company utilizes a proprietary structure-based drug discovery platform to develop broad-spectrum antivirals that target conserved regions of viral enzymes, enhancing efficacy against mutations [4]. - Norovirus presents a significant market opportunity with 685 million global cases annually and a $60 billion economic impact, highlighting the unmet need for effective treatments [4][12]. Influenza Programs - Influenza poses a major health threat with approximately 1 billion cases globally each year, leading to significant morbidity and mortality [6]. - Cocrystal's CC-42344 has demonstrated in vitro activity against various influenza A strains, including those resistant to existing antivirals [8][10]. Financial Results - For Q2 2025, R&D expenses were $1.1 million, down from $4.3 million in Q2 2024, while G&A expenses decreased to $1.0 million from $1.1 million [17]. - The net loss for Q2 2025 was $2.1 million, or $0.20 per share, compared to a net loss of $5.3 million, or $0.53 per share in Q2 2024 [18]. - For the first half of 2025, R&D expenses totaled $2.5 million, down from $7.3 million in the same period of 2024, with a net loss of $4.4 million, or $0.43 per share [19]. Cash Position - As of June 30, 2025, Cocrystal reported unrestricted cash of $4.8 million, a decrease from $9.9 million at the end of 2024 [20].
Traws Pharma Advances Antiviral Pipeline with Multiple Regulatory Submissions
Globenewswire· 2025-06-30 10:30
Core Insights - Traws Pharma is advancing its antiviral pipeline with multiple regulatory submissions for tivoxavir marboxil (TXM) and ratutrelvir, targeting seasonal and bird flu as well as COVID-19 [1][2][3] Group 1: Tivoxavir Marboxil (TXM) - A Phase 2 study protocol has been submitted to evaluate TXM in patients with seasonal influenza and H5N1 bird flu, aiming for a non-inferiority comparison with XOFLUZA® [2][3] - The study will enroll subjects in Australia and Southeast Asia, regions with high rates of human bird flu infections, to assess TXM's efficacy [2][3] - Traws Pharma is in discussions with the FDA regarding accelerated approval pathways for TXM under the Animal Rule [4][3] - TXM is designed as a single-dose oral treatment with demonstrated in vitro activity against various influenza strains, including H5N1 [8] Group 2: Ratutrelvir - A separate Phase 2 study protocol has been submitted for ratutrelvir, a protease inhibitor for newly diagnosed COVID patients, comparing it to PAXLOVID [4][6] - The study will evaluate a 10-day treatment regimen for ratutrelvir against the 5-day regimen for PAXLOVID, focusing on efficacy, safety, disease rebound, and Long COVID incidence [4][5] - Ratutrelvir is positioned as a ritonavir-independent treatment, potentially broadening its use among patients ineligible for PAXLOVID [9][6] Group 3: Market Potential - The seasonal influenza antiviral market represents a multi-billion dollar opportunity, driven by global health organizations and potential pandemic outbreaks [8] - The COVID-19 treatment market also presents significant potential, with ratutrelvir aiming to address gaps in existing therapies [9]
Cocrystal Pharma to Participate in Noble Capital Markets’ 2025 Emerging Growth Virtual Equity Conference
Globenewswire· 2025-05-28 12:00
Core Insights - Cocrystal Pharma, Inc. will participate in a fireside chat at the Noble Capital Markets' 2025 Emerging Growth Virtual Equity Conference on June 5, 2025 [1] - The company is a clinical-stage biotechnology firm focused on developing antiviral therapeutics targeting various viruses [3] Company Overview - Cocrystal Pharma specializes in discovering and developing novel antiviral drugs aimed at noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses [3] - The company utilizes unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral therapeutics [3] Event Details - Registered investors can request one-on-one meetings with Cocrystal management through the conference registration platform [2] - A video webcast of the presentation will be available approximately 48 hours after the event and archived for 90 days on the company's website and Channelchek [2]
Traws Pharma Announces Receipt of FDA Guidance on Tivoxavir Marboxil and Reports Plans for Pursuing Stockpiling for Pandemic Preparedness
Globenewswire· 2025-05-27 12:00
Core Viewpoint - Traws Pharma is advancing the development of tivoxavir marboxil (TXM) as a treatment for bird flu and seasonal influenza, with recent FDA feedback guiding their regulatory strategy and clinical study plans [1][2][3]. Group 1: FDA Interaction and Development Plans - The FDA provided written responses regarding the development paths for TXM, including the potential use of the Animal Rule for approval [1][2]. - Traws Pharma is requesting a Type D meeting with the FDA to clarify next steps in the development process for TXM [2]. - The company aims to conduct a combined clinical study involving subjects infected with seasonal and bird flu [2]. Group 2: Therapeutic Efficacy and Urgency - Positive therapeutic effects of TXM have been observed in three animal models of bird flu, reinforcing the need for rapid progression towards stockpiling and pandemic readiness [3]. - Traws Pharma has initiated discussions with the Biomedical Advanced Research and Development Authority (BARDA) for stockpiling TXM in preparation for potential pandemics [3]. - The historical context of H5N1 virus outbreaks, which have had death rates up to 50%, underscores the urgency of these actions [3]. Group 3: Product Overview and Market Opportunity - 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 [4]. - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government tenders, with additional potential from pandemic outbreaks [4]. - The data supporting TXM's development as a treatment for both bird flu and seasonal flu is considered robust [4].
Cocrystal Pharma Reports First Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
GlobeNewswire News Room· 2025-05-15 12:00
Core Viewpoint - Cocrystal Pharma is advancing its antiviral product pipeline, particularly focusing on CDI-988, a novel oral pan-viral protease inhibitor targeting norovirus and coronaviruses, with promising in vitro results and plans for human challenge studies [2][9][10]. Antiviral Product Pipeline Overview - The company utilizes a structure-based drug discovery platform to develop broad-spectrum antivirals that target conserved regions of viral enzymes, enhancing efficacy against mutations and reducing side effects [3]. - CDI-988 has shown superior antiviral activity against major norovirus strains, including GII.17 and GII.4, and is positioned as a first-in-class treatment [2][9]. Influenza Programs - Influenza poses a significant global health threat, with approximately 1 billion cases and up to 650,000 deaths annually [4]. - Cocrystal's CC-42344, a PB2 inhibitor, has demonstrated excellent in vitro activity against various influenza A strains, including those resistant to existing antivirals [4][8]. Norovirus Program - Norovirus is responsible for an estimated 21 million cases in the U.S. annually, leading to significant healthcare costs and hospitalizations [6]. - There is currently no effective treatment or vaccine for norovirus, highlighting the potential market opportunity for CDI-988 [5][6]. SARS-CoV-2 and Other Coronavirus Program - CDI-988 has shown potent in vitro activity against SARS-CoV-2 and other coronaviruses, with the global COVID-19 therapeutics market projected to exceed $16 billion annually by 2031 [7]. Financial Results - For Q1 2025, research and development expenses were $1.4 million, down from $3.0 million in Q1 2024, primarily due to reduced personnel costs [11]. - The net loss for Q1 2025 was $2.3 million, or $0.23 per share, compared to a net loss of $4.0 million, or $0.39 per share, in Q1 2024 [12]. - As of March 31, 2025, the company reported unrestricted cash of $6.9 million, down from $9.9 million at the end of 2024 [13].
Cocrystal Pharma's Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants
Newsfilter· 2025-04-24 12:00
Core Insights - Cocrystal Pharma's investigational drug candidate CDI-988 demonstrates strong binding and potency against the GII.17 protease, similar to its effectiveness against GII.4 norovirus variants, which have been the dominant strains until recently [1][2] - The company plans to initiate a human norovirus challenge study in 2025 to evaluate CDI-988 for the 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 structural biology 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 against noroviruses and coronaviruses, with a novel mechanism of action [3][4] - A Phase 1 study has been completed, showing favorable safety and tolerability for CDI-988 in healthy adults [3][6] Market Context - Norovirus is the leading cause of acute gastroenteritis globally, with an estimated 685 million cases and around 50,000 child deaths annually, resulting in a societal cost of approximately $60 billion [2] - The emergence of GII.17 variants has led to increased norovirus outbreaks in the U.S. and Europe [6]