Altimmune (ALT) Q1 2025 Earnings Call May 13, 2025 08:30 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Altimmune First Quarter twenty twenty five Financial Results Conference Call. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. As a reminder, this call ...

Financial Position - Altimmune reported cash, cash equivalents, and short-term investments totaling $150 million as of March 31, 2025[10]. - The company secured a $100 million credit facility with Hercules Capital to enhance financial flexibility and support pemvidutide development[5]. Research and Development - Research and development expenses for Q1 2025 were $15.8 million, down from $21.5 million in Q1 2024, reflecting a decrease in clinical trial costs[10]. - Phase 2 trials for Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) are set to initiate in Q2 and Q3 2025, respectively[2]. - Top-line data from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) is expected in Q2 2025[1]. - A total of 212 participants were randomized in the IMPACT Phase 2b trial, exceeding the original plan of 190 participants[6]. - The proportion of participants achieving MASHResInd responses exceeded 90% after 24 weeks of treatment in the Phase 1b trial, indicating potential high rates of MASH resolution[6]. - Pemvidutide has received Fast Track designation from the U.S. FDA for the treatment of MASH, with top-line results from the ongoing IMPACT Phase 2b trial expected in late June 2025[9]. Expenses and Losses - General and administrative expenses increased to $6.0 million in Q1 2025 from $5.3 million in Q1 2024, primarily due to a $0.5 million rise in stock compensation and labor-related expenses[10]. - Net loss for Q1 2025 was $19.6 million, or $0.26 per share, compared to a net loss of $24.4 million, or $0.34 per share, in the same period in 2024[10].

Shares of Altimmune, Inc. (ALT) have gained 39.4% over the past four weeks to close the last trading session at $5.80, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $22.38 indicates a potential upside of 285.9%.The mean estimate comprises eight short-term price targets with a standard deviation of $5.32. While the lowest estimate of $12 indicates a 106.9% increase from the cur ...

MASH Resolution Index (MASHResInd) model highly predictive of MASH resolutionGAITHERSBURG, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing next-generation peptide-based therapeutics for liver and cardiometabolic diseases, today announced the presentation of new analyses at the European Association for the Study of the Liver (EASL) Congress™ in Amsterdam, The Netherlands. The presentation focuses on the use of the MASH Resolution ...

Summary of Altimmune (ALT) Conference Call Company Overview - **Company**: Altimmune - **Focus**: Development of GLP-1 glucagon dual agonist, pembidutide, for multiple indications including NASH (Non-Alcoholic Steatohepatitis) and obesity [7][8] Core Points and Arguments - **Drug Mechanism**: Pembidutide leverages a dual mechanism of action targeting both the liver and weight loss, crucial for treating NASH, where 80% of patients are also obese [8][9] - **Clinical Data**: - Phase 2b data for NASH is expected soon, with a focus on liver health and weight loss [8] - Previous Phase II studies showed a 15.6% weight loss at 48 weeks and a 20% reduction in LDL cholesterol, indicating potential synergy with statins [24][25] - Class-leading liver fat reduction of 76% at 24 weeks, the highest among drugs in development for NASH [26][41] - **Safety Profile**: Over 500 subjects have been exposed to pembidutide, confirming its safety for glycemic control and cardiovascular health, with no major adverse cardiovascular events reported [22][23] - **Regulatory Engagement**: The FDA has acknowledged the safety profile and glycemic control of pembidutide, which is designed to be glucose neutral [18][22] Industry Context - **Resurgence of Glucagon**: The importance of glucagon in obesity and metabolic diseases is being recognized, with multiple companies exploring its benefits [12][14] - **Market Positioning**: Pembidutide is positioned as a comprehensive solution for NASH, combining weight loss and direct liver effects, unlike other agents that only address one aspect [62] Additional Insights - **Patient Selection and Study Design**: The IMPACT trial is designed with 190 subjects, focusing on a 1.8 mg dose compared to placebo, with a robust methodology to minimize bias in biopsy readings [27][28] - **Long-term Effects**: The combination of glucagon and weight loss is expected to yield compounding benefits over time, enhancing treatment outcomes for NASH patients [39][43] - **Future Indications**: Altimmune plans to explore pembidutide for alcohol use disorder (AUD) and alcoholic liver disease (ALD), leveraging its ability to reduce cravings and heal liver inflammation [63][64] Financial Position - **Cash Position**: At the end of 2024, Altimmune expects to have approximately $132 million, sufficient to support ongoing and upcoming milestones, including new indications [68] Upcoming Events - **Earnings Call**: A full update on data and financials is expected in the upcoming earnings call, with significant data anticipated in the second quarter [66][68]

Core Viewpoint - Altimmune, Inc. is set to report its first quarter 2025 financial results on May 13, 2025, and will host a conference call to discuss these results and provide a business update [1]. Group 1: Financial Results Announcement - The company will announce its first quarter 2025 financial results on May 13, 2025 [1]. - A conference call will be held at 8:30 am E.T. on the same day to discuss the financial results [1]. - The conference call will be available via live webcast on Altimmune's Investor Relations website [1]. Group 2: Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing next-generation peptide-based therapeutics [3]. - The company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist aimed at treating obesity, MASH, alcohol use disorder, and alcohol-related liver disease [3].

Core Insights - Altimmune, Inc. is presenting analyses of pemvidutide-treated subjects with metabolic dysfunction-associated steatotic liver disease (MASLD) at the EASL International Liver Congress™ 2025, highlighting the use of the MASH Resolution Index as a non-invasive measure of histologic response [1][2] Group 1: Pemvidutide Overview - Pemvidutide is a novel peptide-based dual receptor agonist targeting GLP-1 and glucagon, aimed at treating obesity, MASH, Alcohol Use Disorder (AUD), and Alcohol Liver Disease (ALD) [3] - The drug has shown significant weight loss, lean mass preservation, and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure in clinical trials [3] - Pemvidutide has received Fast Track designation from the U.S. FDA for MASH treatment and is currently undergoing Phase 2 trials for obesity and MASH [3] Group 2: Company Background - Altimmune is a late clinical-stage biopharmaceutical company focused on developing next-generation peptide-based therapeutics [4] - The company is actively working on pemvidutide for various metabolic and liver-related conditions [4]

Group 1 - Altimmune, Inc. will participate in a fireside chat at the Citizens Life Sciences Conference on May 7, 2025, at 9:30 a.m. EDT [1] - The session will be available via webcast on the Altimmune website [1] - Altimmune is a late clinical-stage biopharmaceutical company focused on next-generation peptide-based therapeutics [2] Group 2 - The company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist aimed at treating obesity, MASH, alcohol use disorder, and alcohol-related liver disease [2]

Core Viewpoint - The obesity drug market is highly lucrative, with Eli Lilly and Novo Nordisk generating billions in sales, prompting other companies like Pfizer to explore acquisition opportunities in this space [1][2]. Group 1: Pfizer's Position and Strategy - Pfizer recently discontinued its experimental obesity drug danuglipron due to safety concerns, putting it at a disadvantage in the obesity market [2]. - The company has nearly $20.5 billion in cash and short-term investments, with a revenue of $63.6 billion and a profit exceeding $8 billion in 2024, despite a significant debt load of around $64 billion [7][8]. Group 2: Potential Acquisition Targets - Altimmune is a promising target for Pfizer, with its experimental GLP-1/glucagon dual receptor agonist pemvidutide having completed successful phase 2 testing for obesity and plans for further studies in liver disorders and alcohol-related diseases [3][4]. - Viking Therapeutics is another potential acquisition candidate, expecting to begin phase 3 testing of its GLP-1/GIP receptor dual agonist VK2735 for obesity this year, alongside ongoing phase 2 studies for an oral formulation [5][6]. Group 3: Financial Feasibility of Acquisitions - Altimmune's market cap is below $400 million, making it a feasible acquisition for Pfizer without incurring additional debt [8]. - Viking Therapeutics has a market cap of nearly $3 billion, but Pfizer could still finance this acquisition comfortably with its cash reserves [9]. Group 4: Future Considerations - Pfizer may delay acquisition decisions until it assesses the clinical development of its other experimental obesity drug, PF-07976016, but must act quickly to avoid losing potential targets to competitors [10][11].

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