Core Insights - Atea Pharmaceuticals has announced promising in vitro results for two oral nucleotide analogs, AT-587 and AT-2490, as potential first-in-class inhibitors for Hepatitis E virus (HEV) infection [2][3] - The company plans to initiate a Phase 1 clinical program for AT-587 in mid-2026, focusing on treating immunocompromised patients with chronic HEV infections [4][5] Company Overview - Atea Pharmaceuticals is a late-stage clinical biopharmaceutical company dedicated to developing oral antiviral therapies for serious viral diseases [7] - The company utilizes a proprietary nucleos(t)ide prodrug platform to create novel product candidates targeting single-stranded RNA viruses [7] Research Findings - In vitro studies revealed that AT-587 and AT-2490 are 30-150 times more potent against HEV compared to existing treatments like sofosbuvir and ribavirin [3] - Both compounds demonstrated antiviral activity in human liver cells without showing any toxicity [3] Market Need - There is currently no approved antiviral therapy for HEV, highlighting a significant unmet medical need, especially for immunocompromised patients at risk of rapid progression to cirrhosis [5][6] - HEV is a global health concern with an estimated 20 million infections annually, particularly affecting vulnerable populations [6]

Core Insights - Traws Pharma has completed a clinical analysis of ratutrelvir, showing it has a differentiated profile compared to PAXLOVID® with fewer adverse events and no viral rebounds, while achieving equivalent time to sustained symptom resolution [1][4] - The company is also advancing tivoxavir marboxil, which has shown increased exposure in pre-clinical studies and is being developed as a once-monthly oral tablet for influenza prevention [5][7] Ratutrelvir Update - The Phase 2 study of ratutrelvir involved 90 patients and compared its efficacy and safety against PAXLOVID®, with a specific focus on patients ineligible for ritonavir-boosted therapies [2][3] - Patients receiving ratutrelvir reported fewer treatment-related adverse events (10% vs. 23.3% for PAXLOVID®) and quicker symptom resolution [3] Clinical Benefits of Ratutrelvir - Ratutrelvir may provide significant benefits for a broader range of patients, particularly those unable to receive ritonavir-boosted therapy, with a favorable tolerability profile and absence of viral rebound events [4] - The drug's potential to reduce post-acute sequelae of SARS-CoV-2 infection (Long COVID) is highlighted, suggesting it may enable earlier and more complete viral clearance [4] Tivoxavir Marboxil Update - Traws Pharma is progressing tivoxavir marboxil as a potential best-in-class CAP-dependent endonuclease inhibitor for seasonal influenza, with a single oral tablet formulation showing a 30% increase in exposure compared to previous formulations [5][7] - The company plans to conduct a healthy volunteer study in Australia to confirm the extended exposure and potentially advance to a Seasonal Human Influenza Virus Prophylaxis Challenge Study [7] Regulatory Considerations - The FDA has placed the US IND for tivoxavir marboxil on clinical hold due to concerns regarding mutagenicity data, with formal communication expected by March 16, 2026 [8] - Despite the clinical hold, ongoing and planned studies outside the United States are not directly impacted, and the company is working to address the FDA's concerns [8]

As filed with the Securities and Exchange Commission on January 23, 2026 Registration No. 333-292085 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 AIM ImmunoTech Inc. (I.R.S. Employer Identification Number) 2117 SW Highway 484 Ocala FL 34473 (352) 448-7797 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Thomas K. Equels Chief Executive Officer AIM ImmunoTech Inc. 2117 SW Highway 484 Oc ...

Core Insights - Resistance to venetoclax, a $2.5 billion therapy for Chronic Lymphocytic Leukemia (CLL), is becoming a significant therapeutic challenge as leukemic cells persist despite combination therapies [1][3] - New in vivo studies indicate that the addition of opaganib, a potent sphingosine kinase 2 (SPHK2) inhibitor, to venetoclax can reduce CLL cell counts by 50% compared to controls, suggesting its potential as an add-on therapy for venetoclax-resistant CLL [1][2] - Opaganib has demonstrated a favorable safety and tolerability profile in over 470 clinical trials and is being evaluated for multiple indications, including oncology and viral infections [1][9] Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [12] - The company promotes the FDA-approved drug Talicia for treating Helicobacter pylori infections and is advancing several late-stage clinical programs, including opaganib [12][13] - Opaganib is currently undergoing a Phase 2 clinical trial in combination with darolutamide for advanced prostate cancer, highlighting its broad therapeutic potential [1][7] Product Insights - Venetoclax, approved by the FDA in 2016, is a first-in-class BCL-2 inhibitor that has become a cornerstone of CLL therapy, achieving sales of approximately $2.5 billion in 2024 [3] - Opaganib is a first-in-class, orally administered drug with anticancer, anti-inflammatory, and antiviral activities, targeting multiple indications including various cancers and viral diseases [6][10] - The drug has received orphan-drug designations from the FDA for cholangiocarcinoma and neuroblastoma, indicating its potential in treating rare diseases [7]

Core Insights - Atea Pharmaceuticals is advancing its global Phase 3 clinical program for the treatment of Hepatitis C Virus (HCV) with a combination regimen of bemnifosbuvir and ruzasvir, expecting topline results from the North American trial by mid-2026 [1][3][6] - New data presented at The Liver Meeting 2025 supports the antiviral potency and unique dual mechanism of action of bemnifosbuvir against HCV, positioning it as a potential best-in-class therapy [1][4][8] - The company is also expanding its antiviral pipeline with a new Hepatitis E Virus (HEV) development program, addressing unmet medical needs in immunocompromised patients [1][5][10] Patient Enrollment and Trials - Patient enrollment for the C-BEYOND trial in the US and Canada is on track to be completed by the end of 2025, while the C-FORWARD trial outside North America is expected to finish enrollment by mid-2026 [3][12] - Each Phase 3 trial is enrolling approximately 880 treatment-naïve patients, comparing the bemnifosbuvir and ruzasvir regimen to the existing regimen of sofosbuvir and velpatasvir [12][13] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $329.3 million, a decrease from $454.7 million at the end of 2024 [19][29] - Research and development expenses increased by $12.2 million year-over-year, primarily due to external spending related to the HCV Phase 3 clinical development program [20] Mechanism of Action - Bemnifosbuvir exhibits a unique dual mechanism of action against HCV, inhibiting both HCV RNA replication and the assembly/secretion of new virions, which enhances its antiviral efficacy [7][8] - The combination regimen of bemnifosbuvir and ruzasvir is designed to suppress the virus at multiple critical stages, potentially leading to a shorter treatment duration of approximately 7 to 8 weeks [14] Upcoming Events - Atea will host a virtual event on November 13, 2025, featuring leading HCV clinical experts discussing current challenges in HCV treatment and the potential benefits of next-generation therapies [16][17]

Core Insights - Bioxytran, Inc. has successfully completed its second randomized double-blind, placebo-controlled clinical trial for its antiviral drug candidate, ProLectin-M, which is expected to inform the design of a phase 3 trial and will be submitted to the FDA [1][2] Group 1: Clinical Trial Results - The second randomized controlled trial aimed to confirm the results from an earlier Phase 2 study, which showed that ProLectin-M achieved undetectable levels of PCR and infection in less than one week for treated participants [2] - The successful execution of this trial strengthens the evidence for ProLectin-M as a rapid-acting oral therapeutic for various viral infections [2][4] Group 2: Future Plans and Publications - Comprehensive data from the third clinical trial, including safety and efficacy endpoints, is expected to be compiled for publication in a peer-reviewed medical journal in the coming weeks [3] - The company anticipates that the full results will be submitted for publication soon [3] Group 3: Company Vision and Impact - The CEO of Bioxytran, Dr. David Platt, stated that the completion of the trial represents a significant achievement and a potential paradigm shift in antiviral therapy, highlighting the rapid targeting of undetectable viral presence across multiple trials [4] - ProLectin-M is positioned as the first oral antiviral drug based on sugar chemistry, which could fundamentally change the management of viral outbreaks [4][6]

Core Insights - Bioxytran, Inc. has successfully completed its second randomized double-blind, placebo-controlled clinical trial for its antiviral drug candidate, ProLectin-M, which is expected to inform the design of a phase 3 trial and will be submitted to the FDA [1][2] Group 1: Clinical Trial Results - The second randomized controlled trial aimed to confirm results from an earlier Phase 2 study, which showed ProLectin-M achieved undetectable levels of PCR and infection in less than one week for treated participants [2] - The successful execution of this trial strengthens the evidence for ProLectin-M as a rapid-acting oral therapeutic for various viral infections [2][4] Group 2: Future Plans and Publications - Comprehensive data from the third clinical trial, including safety and efficacy endpoints, is expected to be compiled for publication in a peer-reviewed medical journal in the coming weeks [3] - The company anticipates that the full results will be submitted for publication soon [3] Group 3: Company Vision and Impact - The CEO of Bioxytran stated that the completion of the trial represents a significant achievement and a potential paradigm shift in antiviral therapy, highlighting the rapid targeting of undetectable viral presence across multiple trials [4] - ProLectin-M is positioned as the first oral antiviral drug based on sugar chemistry, which could fundamentally change the management of viral outbreaks [4][6]

Core Viewpoint - Theralase Technologies Inc. has announced the peer-reviewed publication of preclinical data demonstrating that its antiviral candidate Ruvidar® is more effective than Acyclovir® and Metformin® in treating Herpes Simplex Virus Type 1 (HSV-1) [1][2][3] Company Summary - Theralase Technologies Inc. is a clinical stage pharmaceutical company focused on developing light, radiation, sound, and drug-activated therapeutics for treating various diseases, including cancer and viral infections [1][8] - The company is advancing Ruvidar® into clinical development, with plans for a Phase I/II adaptive clinical study in 2026 to assess its safety and efficacy in treating cold sore lesions [1][6] Research Findings - The latest research published in MDPI - Viruses indicates that Ruvidar® significantly inhibits HSV-1 replication post-infection, unlike Acyclovir® and Metformin®, which show little effect once infection is established [2][3] - Ruvidar® has demonstrated effectiveness against Acyclovir®-resistant HSV-1 mutants, highlighting its potential as a next-generation antiviral therapy [3][4] - The combination of Ruvidar® with Acyclovir® proved to be more effective than either treatment alone, suggesting potential for combinational therapies [4][6] Market Context - The global HSV treatment market was estimated at $2.8 billion in 2024 and is projected to grow to $4.7 billion by 2033, indicating a significant opportunity for effective antiviral treatments like Ruvidar® [8]

Core Insights - The ongoing mpox outbreak is a significant global health threat, necessitating increased therapeutic research and innovation [1][3] - Emergent BioSolutions has published a comprehensive review on brincidofovir, highlighting its investigational use for treating mpox infections [1][5] Company Overview - Emergent BioSolutions is focused on developing protective solutions against public health threats, including mpox, and has over 25 years of experience in this field [6] Research and Development - Brincidofovir is being evaluated in a double-blind, placebo-controlled clinical trial (MOSA) in Africa, initiated in January 2025, in partnership with Africa CDC and PANTHER [4] - The trial aims to assess the safety and efficacy of brincidofovir for mpox patients, with initial funding from Horizon Europe and Africa CDC [4] Public Health Context - The World Health Organization declared the current mpox outbreak a Public Health Emergency of International Concern (PHEIC) on August 14, 2024, marking the second such declaration in two years [3] - The U.S. Centers for Disease Control and Prevention has reported a surge in mpox cases globally [3]

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]