Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024, primarily due to $35 million raised from the ATM facility [22][20] - R&D expenses for Q1 2025 were $15.8 million, down from $21.5 million in the same period of 2024, with $9.2 million specifically related to pemidutide development [22][24] - General and administrative expenses rose to $6 million from $5.3 million in Q1 2024, mainly due to increased non-cash stock compensation [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant progress in the NASH program, including the upcoming readout of the IMPACT Phase 2b MATCH trial [8][12] - The trial enrolled 212 participants with biopsy-confirmed F2F3 NASH, enhancing the study's power [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), with plans for Phase II trials in these areas [9][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [18] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, focusing on NASH, AUD, and ALD [10][19] - The strategic partnership with Hercules Capital for a $100 million credit facility is intended to support the ongoing development of pemidutide [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [8][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected from the IMPACT trial and the initiation of Phase II trials for AUD and ALD [19][24] Other Important Information - The company is preparing for an end-of-Phase II meeting with the FDA in Q4 2025, which will discuss the potential for accelerated approval in F4 cirrhosis [78][79] - The company has a large safety database for pemidutide, which may allow for more efficient trial designs in Phase III [73] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population are similar to other studies, but precise numbers will be presented later [28][29] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30][31] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [36] Question: How important is weight loss in this study? - Weight loss is crucial, as it addresses comorbidities associated with NASH, and the company aims to achieve clinically meaningful weight loss [40][41] Question: What are the expected placebo responses for fibrosis and NASH resolution endpoints? - Management noted that placebo responses have varied historically, but they expect to control the placebo response effectively in their trial [87][88] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes they will be successful in this area [78][79] Question: Can you confirm the cash runway with the Hercules facility? - The facility will provide $15 million upfront, with additional tranches available, potentially extending the cash runway into Q3 2026 [81][82]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024 [22] - R&D expenses were $15.8 million for Q1 2025, down from $21.5 million in the same period of 2024 [22] - The 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, for Q1 2024 [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant R&D investments directed towards its clinical trials [8][22] - The IMPACT Phase 2b MATCH trial has enrolled 212 participants, enhancing the study's power compared to the original target [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), both of which have significant unmet medical needs [8][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [17] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, including NASH, AUD, and ALD [10][18] - The upcoming readout of the IMPACT Phase 2b MATCH trial is expected to be a transformative event for the company, with plans for Phase III trials in NASH following successful results [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [7][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected in clinical development [24] Other Important Information - The company has entered into a credit facility with Hercules Capital for up to $100 million, providing flexibility to support the development of pemidutide [8][20] - The facility includes a $15 million upfront funding and additional tranches available based on milestones [21] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population will be similar to other studies, but precise numbers cannot be disclosed yet [28] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [38] Question: How important is weight loss in the study? - Weight loss is crucial, as it impacts the treatment of NASH patients, and the company aims to achieve clinically significant weight loss [41] Question: Will you consider taking a higher dose into Phase III? - The company is strongly considering the 2.4 mg dose for Phase III due to its expected better weight loss outcomes [49] Question: What is the expected range of placebo responses? - The company anticipates a placebo response range of 7% to 13% based on historical data and the trial's design [90] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes it can be successful in this area [80]

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 ...

Core Insights - Altimmune, Inc. presented new analyses at the EASL Congress™ highlighting the predictive capability of the MASH Resolution Index (MASHResInd) for MASH resolution in patients treated with pemvidutide, a dual receptor agonist [1][2] Group 1: MASH Resolution Index (MASHResInd) - MASHResInd is a composite score that integrates multiple non-invasive tests, including MRI-PDFF, ALT, and AST levels, to predict MASH resolution on biopsy [2] - In a trial involving pemvidutide for MASLD, MASHResInd indicated a high probability of MASH resolution with treatment [2] Group 2: Pemvidutide Treatment Results - After 24 weeks of treatment, MASHResInd responses were observed in 69.2%, 92.3%, and 90.9% of subjects receiving 1.2 mg, 1.8 mg, and 2.4 mg of pemvidutide, respectively, compared to 22.2% in the placebo group [3][4] - The results suggest that pemvidutide may lead to significant histologic improvements in MASH, with high response rates at the higher doses [3][4] Group 3: Future Developments - The upcoming IMPACT Phase 2b Trial readout is anticipated to be reported this quarter, with confidence in achieving statistical significance based on the trial's results [4] - Pemvidutide has received Fast Track designation from the U.S. FDA for the treatment of MASH and is also being studied for obesity, alcohol use disorder, and alcohol-related liver disease [8][9]

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].