Summary of Altimmune Conference Call Company Overview - **Company**: Altimmune - **Product**: GLP-1/glucagon dual agonist for MASH (Metabolic Associated Steatotic Liver Disease) and weight loss Key Points Product Development and Efficacy - Altimmune is developing a GLP-1/glucagon dual agonist that targets liver effects and metabolic benefits, showing promising results in a 24-week Phase 2 trial with class-leading MASH resolution and significant weight loss of approximately 6% at 24 weeks [2][3][20] - The drug demonstrated excellent tolerability without dose titration, which is crucial for patient adherence [3][12] - The treatment shows rapid effects on liver health and weight loss, with expectations of continued improvement as treatment progresses [20][23] Regulatory Considerations - The company is preparing for potential FDA approval based on MASH resolution endpoints, with a focus on both traditional biopsy-based and non-invasive tests (NITs) [11][25] - AI-enabled histological assessments for fibrosis are being considered, with positive feedback expected from the FDA in Q4 [8][9][25] - Altimmune plans to incorporate flexibility in trial design to adapt to regulatory changes, potentially moving away from biopsy requirements [25][26] Market Positioning and Competitive Landscape - The recent interest from large pharmaceutical companies in MASH treatments indicates a growing market, with Altimmune positioned to leverage its dual-action therapy [28][30] - The company believes that its single-molecule approach, which combines liver-targeting and metabolic effects, offers a competitive advantage over combination therapies that require multiple drugs [29][34] - Altimmune aims to treat a broad spectrum of patients (F1 to F4) with its drug, addressing both early and late-stage MASH patients [32][33] Financial and Strategic Outlook - Altimmune is focused on improving its balance sheet to fund the Phase 3 trial and is exploring various funding options [39] - The company holds Fast Track status for alcohol use disorder (AUD) and is optimistic about its ongoing trials in this area, with expected readouts in 2026 [36][38] Additional Insights - The company emphasizes the importance of early efficacy in treatment to maintain patient adherence, which is critical given the high discontinuation rates seen with other GLP-1 therapies [16][17] - Altimmune's strategy is to prioritize high-value treatments for complex diseases rather than competing directly in the obesity market, positioning itself as a multifaceted solution provider [38] This summary encapsulates the key insights from the Altimmune conference call, highlighting the company's innovative approach to treating MASH and its strategic positioning in the market.

Seasoned clinical leader to oversee Phase 3 development of pemvidutide in MASH Dr. Arbet-Engels has led late-stage development, regulatory approvals and commercial launches for multiple successful franchises GAITHERSBURG, Md., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced the appointment of Christophe Arbet-Engels, MD, PhD as Chief Medical Of ...

GAITHERSBURG, Md., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that members of the Company’s management team will participate and be available for 1x1 meetings at the following investor conferences: Stifel 2025 Virtual Cardiometabolic ForumTuesday, September 30, 2025Fireside Chat at 10:30 a.m. Eastern Time H.C. Wainwright Liver Disease Virt ...

Core Insights - Altimmune, Inc. has appointed Linda M. Richardson as Chief Commercial Officer, effective September 16, 2025, bringing over 30 years of experience in sales, marketing, and business development across various therapeutic areas [1][2] - The appointment is seen as a strategic move as the company approaches the initiation of Phase 3 development of pemvidutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [2] - Richardson believes pemvidutide has significant potential to improve patient outcomes in hepato-metabolic diseases and sees opportunities in Alcohol Use Disorder and Alcohol-associated Liver Disease [2] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [5] - The lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist targeting MASH, Alcohol Use Disorder, Alcohol-associated Liver Disease, and obesity [5] Inducement Grant Details - As part of her appointment, Richardson will receive options to purchase 278,000 shares and 96,000 restricted stock units (RSUs) [3][4] - The options will vest over four years, with one-fourth vesting on the one-year anniversary of the grant date [3][4]

Company Overview - Altimmune is focused on developing a GLP-1 glucagon dual receptor agonist aimed at treating serious liver diseases, particularly MASH [1] - The drug, named pemvidutide, is designed to have direct effects on the liver while also providing metabolic benefits [1] Mechanism of Action - Glucagon has a direct effect on the liver, while GLP-1 contributes to metabolic benefits such as weight loss [2] - The optimal approach to treating MASH involves targeting the liver directly [2]

Company Overview - Altimmune is focused on developing a GLP-1 glucagon dual receptor agonist for the treatment of serious liver diseases, specifically MASH [1] - The drug, named pemvidutide, is designed to have direct effects on the liver while also providing metabolic benefits [1] Mechanism of Action - Glucagon has a direct effect on the liver, while GLP-1 contributes to metabolic benefits such as weight loss [2] - The optimal approach to treating MASH involves targeting the liver directly [2]

Summary of Altimmune Fireside Chat Company Overview - **Company**: Altimmune - **Focus**: Development of pemvidutide, a GLP-1/glucagon dual receptor agonist for treating serious liver diseases, particularly NASH (Non-Alcoholic Steatohepatitis) [3][4] Core Points and Arguments Pemvidutide and NASH - Pemvidutide is designed to have direct effects on the liver and provide metabolic benefits, primarily through weight loss [3][4] - Approximately 80% of NASH patients are overweight or obese, indicating that addressing both liver health and weight is crucial for treatment [4] - The drug shows significant reductions in liver fat, inflammation, and fibrosis, alongside weight loss [4] - Currently in a 48-week phase 2b trial for NASH, with 24-week data recently reported [5][6] Trial Design and Results - The phase 2b trial enrolled 212 patients with three treatment arms: placebo, 1.2 mg, and 1.8 mg of pemvidutide [6][7] - Class-leading NASH resolution was observed at the 24-week biopsy endpoint, exceeding results from other compounds [7][8] - Non-invasive tests showed robust anti-inflammatory and anti-fibrotic activity, with results indicating potential for FDA approval based on these tests [8][9] - The company plans to meet with the FDA to discuss transitioning from biopsy-based endpoints to non-invasive test-based endpoints for phase 3 trials [10][12] FDA Engagement and Future Plans - The company aims to align with the FDA on trial design, dose regimens, and endpoints during the end-of-phase 2 meeting [12][13] - Pemvidutide has shown excellent tolerability with no adverse event discontinuations, a significant advantage over other NASH treatments [15][17] - The company is preparing for phase 3 trials in NASH, expected to start in 2026 [5][10] Broader Implications and Market Position - The treatment landscape for NASH is evolving, with recent approvals for other drugs like semaglutide, which primarily focuses on metabolic components [23][24] - The combination of direct liver effects and weight loss in pemvidutide is positioned as a unique advantage over existing therapies [24][25] - The company is also exploring the use of pemvidutide in treating Alcohol Use Disorder (AUD) and Alcoholic Liver Disease (ALD), with ongoing trials [34][36] Additional Important Insights - The FDA has accepted applications for non-invasive tests, indicating a shift towards less invasive methods for evaluating liver health [9][10] - Pemvidutide's weight loss efficacy at the 2.4 mg dose was reported at 15.6% over 48 weeks, with potential for greater weight loss over longer periods [26][27] - The drug's ability to preserve lean mass during weight loss is highlighted as a critical factor, especially for older patients [28][29] - The company has received fast track status for AUD, emphasizing its commitment to addressing serious conditions related to obesity [39] Conclusion Altimmune is strategically positioned in the NASH treatment landscape with pemvidutide, focusing on both liver health and weight loss. The upcoming phase 3 trials and FDA meetings are critical milestones for the company's future in addressing serious liver diseases and related conditions.

Summary of MetaVia (MTVA) FY Conference Call - September 05, 2025 Company Overview - **Company**: MetaVia Inc. - **Industry**: Biotechnology, focusing on metabolic diseases and obesity Key Points Product Pipeline - **DA-1726**: A GLP-1/glucagon dual agonist, once-weekly injectable peptide targeting obesity - **Mechanism**: Balances GLP-1 (decreases appetite, controls glucose) and glucagon (energy burn, fat breakdown) [3][4] - **Clinical Results**: Phase 1 results showed significant glucose control and over 4% weight loss in four weeks at 32 mg dose [10][11] - **Current Study**: Ongoing Phase 1 study with a 48 mg cohort to assess safety and efficacy over eight weeks [12][19] - **Target Outcomes**: Aiming for 7% weight loss and improved HbA1c levels [19][34] - **DA-1241**: A small molecule, once-daily oral pill targeting NASH (Non-Alcoholic Steatohepatitis) - **Mechanism**: Increases natural GLP-1 production and has direct hepatic effects [5][25] - **Clinical Results**: Phase 2A showed promising data in presumed NASH patients [5][28] - **Combination Strategy**: Exploring combinations with FGF21 analogues and other drugs to enhance efficacy [26][27] Competitive Landscape - **DA-1726 vs Competitors**: Differentiated by a unique three-to-one GLP-1/glucagon ratio, which is believed to provide better glucose control compared to competitors like pemvidutide and retatrutide [7][8][10] - **NASH Market**: Acknowledges a crowded market with a focus on combination therapies to address the complexity of the disease [28][29] Strategic Partnerships - **Future Collaborations**: Open to partnerships with larger pharmaceutical companies to maximize the potential of DA-1726 and DA-1241 [23][30] - **AI-Driven Research**: Collaborating with Synteca Bio to identify new indications for DA-1241, potentially reducing the time for development [31] Long-Term Vision - **Maintenance Drug Strategy**: Aiming to develop a maintenance drug that minimizes gastrointestinal issues and supports long-term weight management without continuous drug dependency [34][35] - **Market Positioning**: Focused on creating a drug that allows patients to achieve weight loss and maintain a healthier lifestyle post-treatment [34] Financial and Market Considerations - **Market Size**: Recognizes the significant market potential for obesity and metabolic disease treatments, emphasizing the need for effective and tolerable therapies [23][34] Additional Insights - **Safety Profile**: DA-1726 has shown a favorable safety profile with minimal adverse effects compared to competitors [10][31] - **Patient Retention**: Acknowledges high dropout rates in existing GLP-1 treatments and aims to address this with a more tolerable option [34] This summary encapsulates the key discussions and insights from the MetaVia conference call, highlighting the company's strategic direction, product development, and market positioning in the biotechnology sector focused on metabolic diseases.

Company Overview - Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [1] - The company's lead product candidate is pemvidutide, a GLP-1/glucagon dual receptor agonist targeting MASH, Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD), and obesity [1] Investor Engagement - Management will participate in several upcoming investor conferences, including the Wells Fargo Healthcare Conference on September 5, 2025, and the H.C. Wainwright Global Investment Conference on September 9, 2025 [3] - The Morgan Stanley Global Healthcare Conference is scheduled for September 10, 2025, where a fireside chat will take place [3] - These events will include one-on-one meetings and webcasts accessible via the Altimmune website [3]

Core Viewpoint - The FDA has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder (AUD), highlighting the urgent need for effective treatments in this area [1][3][5] Group 1: Pemvidutide and Clinical Trials - Pemvidutide is currently undergoing a Phase 2 trial named RECLAIM, which is enrolling approximately 100 patients to evaluate its safety and efficacy in treating AUD [2][6] - The trial will randomize participants to receive either 2.4 mg of pemvidutide or a placebo weekly for 24 weeks, with the primary endpoint being the change in the average number of heavy drinking days [2] - Pemvidutide has shown potential in preclinical models to significantly reduce alcohol intake, supporting its use in treating AUD [3][7] Group 2: Market Need and Treatment Gap - An estimated 28 million adults in the U.S. suffer from AUD, yet only 2% are currently treated with medication, indicating a significant treatment gap [3][5] - Existing FDA-approved therapies for AUD have limited efficacy and do not adequately address comorbidities such as hepatic steatosis and hypertension [3][5] - The World Health Organization identifies harmful alcohol consumption as a leading cause of global death and disability, emphasizing the need for effective treatments [4] Group 3: Mechanism and Benefits of Pemvidutide - Pemvidutide acts as a dual receptor agonist for GLP-1 and glucagon, which may help in weight loss and reducing alcohol cravings [6][7] - In previous trials, pemvidutide demonstrated significant improvements in liver fat content, weight loss, and blood pressure, indicating its potential as a comprehensive treatment for AUD and related conditions [7] - The ongoing IMPACT Phase 2b trial is expected to provide further insights into pemvidutide's efficacy in treating Metabolic Dysfunction-Associated Steatohepatitis (MASH) and its potential benefits for AUD [7]