Question-and-Answer SessionAbsolutely. All right. So maybe, Vipin, you can start with some elevated pitch and then to see what's the state of the union for Altimmune today?Vipin GargPresident, CEO & Director Yes. So we are developing -- as you know, we are developing a glucagon GLP-1 dual receptor agonist for MASH, for liver diseases, MASH, AUD and ALD, it's a rationally designed molecule with 1:1 ratio of GLP-1 and glucagon. And we think that's very important really in order to drive the glucagon function, ...

Altimmune (NasdaqGM:ALT) 2025 Conference November 20, 2025 03:00 AM ET Company ParticipantsVipin Garg - CEOChristophe Arbet-Engels - Chief Medical OfficerConference Call ParticipantsRoger Song - Senior AnalystRoger SongAll right. Good morning, everyone, to Jeffrey's London Healthcare Conference 2025. My name is Roger Song, one of the Senior Analysts covering SMID Cap Biotech in the U.S.. It is my great pleasure to have the next fireside chat with Altimmune, who have Vipin and then Christophe. Good to meet y ...

Core Insights - Altimmune, Inc. announced significant 24-week efficacy and safety data from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), showing promising results in MASH resolution, weight loss, and anti-fibrotic activity [1][3][5] Group 1: Trial Results - The IMPACT Phase 2b trial demonstrated that pemvidutide achieved statistically significant MASH resolution without worsening fibrosis, with 58% and 52% of patients in the 1.2 mg and 1.8 mg groups respectively achieving this outcome compared to 20% in the placebo group [6] - Significant improvements were observed in secondary endpoints, including a reduction in liver stiffness measurement and Enhanced Liver Fibrosis score, with the 1.2 mg and 1.8 mg groups showing reductions of -3.7 kPa and -2.2 kPa respectively [6] - The trial also reported a normalization of liver fat content in 31% and 44% of patients in the 1.2 mg and 1.8 mg groups respectively, compared to only 4% in the placebo group [6] Group 2: Safety and Tolerability - Pemvidutide exhibited a favorable tolerability profile, with only 2% of placebo patients experiencing adverse events leading to treatment discontinuation, compared to 0% in the 1.2 mg group and 1% in the 1.8 mg group [6] - Serious adverse events were reported in 3% of placebo patients, 2% in the 1.2 mg group, and 4% in the 1.8 mg group, with no serious adverse events deemed related to the treatment [6] Group 3: Future Outlook - The final readout of longer-term non-invasive tests and weight loss from the IMPACT trial is anticipated in the fourth quarter of 2025, which will provide further insights into the efficacy of pemvidutide [7][10] - The FDA has granted Fast Track designations to pemvidutide for the treatment of MASH and alcohol use disorder (AUD), indicating significant unmet medical needs in these areas [10]

Group 1 - Citizens JMP analyst Jonathan Wolleben lowered the price target on Altimmune (ALT) to $14 from $15 while maintaining an Outperform rating on the shares [1] - The firm anticipates the oral late-breaking presentation of pemvidutide's Phase 2b data at the Liver Meeting, with 48-week data expected to be released this quarter [1]

Core Insights - Altimmune, Inc. announced significant results from the IMPACT Phase 2b trial of pemvidutide, demonstrating reductions in liver fibrosis and improvements in non-invasive tests compared to placebo at 24 weeks [1][2][5] Group 1: Trial Results - The AI-based pathology tool Liver Explore™ showed significant reductions in early, advanced, and total liver fibrosis areas with pemvidutide treatment compared to placebo at 24 weeks [2] - In the trial, 58% of patients achieved MASH resolution, indicating the efficacy of the glucagon/GLP-1 balanced approach in pemvidutide [5] - Statistically significant reductions in total liver fibrosis were observed, with 31% of patients in the 1.8 mg group achieving a ≥ 60% reduction compared to 8% in the placebo group [7] Group 2: Study Design - The IMPACT Phase 2b trial was a randomized, placebo-controlled, double-blind study involving 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3 [6] - Participants were randomized to receive weekly subcutaneous doses of pemvidutide at either 1.2 mg, 1.8 mg, or placebo for 48 weeks, with key efficacy endpoints measured at 24 weeks [6] Group 3: Mechanism and Future Outlook - Pemvidutide is a novel investigational peptide with dual receptor agonist activity targeting both glucagon and GLP-1, aimed at treating MASH, AUD, and ALD [8] - The FDA has granted Fast Track designations for pemvidutide in treating MASH and AUD, highlighting the unmet medical need in these areas [9] - The final readout of the ongoing 48-week IMPACT trial is anticipated in the fourth quarter of 2025, which will include longer-term data on non-invasive tests and weight loss [9]

Core Insights - Altimmune, Inc. is approaching significant milestones in the development of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH) and alcohol use disorder (AUD) [2][12] - The company has strengthened its executive leadership team with key appointments to support its growth strategy [2][9] - Financial results indicate a robust cash position and a reduction in research and development expenses compared to the previous year [7][19] MASH Program Updates - The 48-week data from the Phase 2b IMPACT trial of pemvidutide is expected to be released before the end of 2025 [2][12] - An End-of-Phase 2 meeting with the FDA is scheduled for the fourth quarter of 2025 to discuss the proposed design of the Phase 3 trial [5][12] - The trial design may include flexibility to adapt based on regulatory discussions regarding non-invasive tests and AI-based biopsy readings [2] AUD and ALD Trials - The RECLAIM trial for pemvidutide in AUD has completed patient recruitment ahead of schedule, indicating strong interest in new therapies for this condition [9][12] - The RESTORE trial for pemvidutide in alcohol-associated liver disease (ALD) has also been initiated, with a focus on safety and efficacy [9][12] Executive Leadership Changes - Recent appointments include Dr. Christophe Arbet-Engels as Chief Medical Officer, Linda Richardson as Chief Commercial Officer, and Robin Abrams as Chief Legal Officer [2][9] - These leaders bring extensive experience in clinical development, commercial strategy, and legal compliance to the company [9] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling approximately $211 million, a 60% increase from $131.9 million at the end of 2024 [7][19] - Research and development expenses decreased to $15 million from $19.8 million year-over-year, reflecting a strategic focus on cost management [19] - The net loss for the quarter was $19 million, or $0.21 per share, an improvement from a net loss of $22.8 million, or $0.32 per share, in the same period in 2024 [19]

Core Insights - Altimmune, Inc. has completed patient enrollment in the RECLAIM Phase 2 clinical trial for pemvidutide in adults with alcohol use disorder (AUD) ahead of schedule, indicating strong interest from the patient community [1][2] - The trial involves approximately 100 patients and aims to announce topline results in 2026 [1][2] - Pemvidutide is positioned as a potential therapeutic advance for AUD, targeting cravings and addressing alcohol-related liver damage [2][6] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [9] - The lead product candidate, pemvidutide, is a dual receptor agonist targeting metabolic dysfunction-associated steatohepatitis (MASH), AUD, and alcohol-associated liver disease (ALD) [9] Clinical Trials - The RECLAIM trial evaluates the safety and efficacy of pemvidutide in AUD, with a primary endpoint of reducing heavy drinking days and secondary endpoints including changes in WHO risk drinking levels and serum biomarker levels [2][8] - Concurrently, Altimmune is enrolling patients in the RESTORE Phase 2 trial for ALD [3][8] - The FDA has granted Fast Track designations to pemvidutide for both MASH and AUD, highlighting the significant unmet medical need in these areas [7] Market Context - Approximately 28 million adults in the U.S. suffer from AUD, with a significant portion presenting with comorbidities such as obesity and liver fat [5] - Current FDA-approved treatments for AUD have limited efficacy and are used by less than 2% of patients, indicating a substantial unmet need for more effective therapies [5]

Core Insights - Altimmune, Inc. (ALT) is conducting multiple trials of pemvidutide, which allows the company to differentiate its asset in the market [1] - As of July, ALT was rated a hold, indicating a cautious approach to its stock performance [1] - The company has not yet secured a partner or been acquired, which may impact its future growth prospects [1] Company Overview - Altimmune is focused on trading around significant events such as trial results and NDA/BLA approvals, which are critical in the biotech sector [1] - The company operates in an industry regulated by the FDA, highlighting the importance of compliance and regulatory approvals for its products [1]

Core Points - Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases [3] - The company will report its third quarter 2025 financial results on November 6, 2025 [1] - A conference call will be held on the same day at 8:30 a.m. ET to discuss the financial results and provide a business update [2] Company Overview - Altimmune's lead product candidate is pemvidutide, a glucagon/GLP-1 dual receptor agonist targeting metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), alcohol-associated liver disease (ALD), and obesity [3] - The company is committed to developing innovative treatments for significant health issues related to liver and cardiometabolic conditions [3]

Summary of the Conference Call on Altimmune and Pemvidutide Company Overview - **Company**: Altimmune - **Product**: Pemvidutide - **Focus**: Clinical-stage biotechnology company developing treatments for metabolic dysfunction-associated steatohepatitis (MASH) Key Industry Insights - **Event**: HC Wainwright Virtual Liver Disease Conference - **Context**: The conference combined discussions on viral hepatitis, MASH, and liver cancer, highlighting the growing interest in liver disease therapeutics Core Points and Arguments 1. **Pemvidutide Mechanism**: Pemvidutide is a dual GLP-1/glucagon receptor agonist, designed to treat multiple components of MASH through direct liver effects and metabolic benefits [2][3] 2. **Clinical Data**: The 24-week study showed class-leading MASH resolution of approximately 59% of patients, with expectations for even better results at the upcoming 48-week data readout [5][8] 3. **Weight Loss and Liver Fat**: At the 1.8 mg dose, patients experienced over 6% weight loss, with about 50% normalizing liver fat [6][8] 4. **Tolerability Profile**: Pemvidutide demonstrated the lowest rates of adverse event discontinuations among incretins, with only 1% overall discontinuation due to adverse events [16][17] 5. **Regulatory Strategy**: The company is preparing for an end of phase 2 meeting with the FDA, focusing on the design of the phase 3 program and the potential use of non-invasive tests (NITs) as surrogates for biopsies [13][15] 6. **Market Opportunity**: MASH represents a significant commercial opportunity, targeting patients across various fibrosis stages (F2 to F4) [22][23] 7. **Competitive Positioning**: Altimmune believes that pemvidutide's dual mechanism provides a unique advantage over other therapies that typically focus on either metabolic or liver effects [20][25] Additional Important Insights - **Upcoming Milestones**: The company anticipates presenting 48-week data and having an end of phase 2 meeting with the FDA in the fourth quarter, which are critical for advancing to phase 3 trials [26] - **Combination Therapies**: There is a trend in the industry towards combination therapies for MASH, and pemvidutide's ability to address both liver and metabolic issues in a single molecule positions it favorably [24][25] - **Investor Sentiment**: The management team expressed confidence in pemvidutide's differentiation and readiness for phase 3, emphasizing the importance of upcoming data and regulatory discussions for investor interest [26] This summary encapsulates the key points discussed during the conference call, focusing on Altimmune's pemvidutide and its implications for the MASH treatment landscape.