Core Viewpoint - Aligos Therapeutics, Inc. has announced that eight abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) Congress 2025, highlighting its focus on innovative therapies for liver and viral diseases [1]. Group 1: Abstracts on Chronic Hepatitis B Virus (HBV) - Abstract 861 discusses the monotherapy with the novel capsid assembly modulator ALG-000184, showing profound and sustained HBV DNA suppression in untreated subjects over 96 weeks [2]. - Abstract 856 presents the safety and antiviral effect of oral daily 300 mg ALG-000184 in combination with Entecavir for untreated HBeAg-positive subjects, also over 96 weeks [3]. - Abstract 1924 reveals a high barrier of resistance to ALG-000184 based on viral kinetics and sequence analysis from a phase I monotherapy study [3]. Group 2: Abstracts on Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Abstract 302 highlights that ALG-055009, a novel thyroid hormone receptor beta agonist, significantly reduces atherogenic lipids/lipoproteins in patients with presumed MASH in the Phase 2a HERALD study [4]. - Abstract 2185 indicates robust reductions in liver fat at Week 12 across subgroups, including GLP-1 receptor agonist users in non-cirrhotic MASH patients [4]. - Abstract 2152 discusses population pharmacokinetic/pharmacodynamic modeling of ALG-055009, showing a statistically significant correlation between exposure and key efficacy endpoints [5]. Group 3: Preclinical Research - Abstract 2105 presents next-generation hepatitis B virus antisense oligonucleotides with significantly improved properties compared to current clinical candidates [6]. Company Overview - Aligos Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing best-in-class therapies for liver and viral diseases, leveraging its R&D expertise to address high unmet medical needs [6].

Group 1: 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 influenza, coronaviruses (such as SARS-CoV-2), noroviruses, 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 drugs [3] Group 2: Event Information - Sam Lee, President and co-CEO of Cocrystal Pharma, will present a company overview at the Life Science Innovation Northwest (LSINW) 2025 Conference on April 23, 2025, at 3:00 p.m. Pacific time [1] - The LSINW conference is the largest annual life science event in the Pacific Northwest, featuring over 700 attendees and 80+ presentations from companies and research institutions [2] - The conference includes keynote addresses from industry leaders, panel discussions on emerging trends, and a startup fast pitch showdown, making it a significant event for the life science community in the region [2]

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 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 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].

SIGA Technologies, Inc. (NASDAQ:SIGA) Q4 2024 Earnings Conference Call March 11, 2025 4:30 PM ET Company Participants Diem Nguyen - Chief Executive Officer Dan Luckshire - Executive Vice President and Chief Financial Officer Conference Call Participants Jyoti Prakash - Edison Group Brian Adams - Carter, Terry & Company Operator Welcome to the SIGA Business Update Call. Before we turn the call over to SIGA management, please note that any forward-looking statements majoring this call are based on management' ...