Core Viewpoint - Altimmune, Inc. is set to present topline data from its IMPACT Phase 2b trial evaluating pemvidutide for treating metabolic dysfunction-associated steatohepatitis (MASH) on June 26, 2025 [1][2]. Group 1: Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases [5]. - The company's lead program, pemvidutide, is a GLP-1/glucagon dual receptor agonist aimed at treating MASH, obesity, Alcohol Use Disorder (AUD), and Alcohol-associated Liver Disease (ALD) [5]. Group 2: IMPACT Study Details - The IMPACT trial enrolled 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at doses of 1.2 mg and 1.8 mg or placebo for 24 weeks [3]. - Key efficacy endpoints include MASH resolution or fibrosis improvement at 24 weeks, with secondary endpoints focusing on weight loss and non-invasive tests [3]. - A total of 48 weeks of treatment is planned, with final readout expected in Q4 2025 [3]. Group 3: Pemvidutide Characteristics - Pemvidutide is an investigational peptide-based dual receptor agonist that mimics the effects of diet and exercise on weight loss, suppressing appetite and increasing energy expenditure [4]. - Clinical trials have shown significant MASH resolution, liver fibrosis improvement, and weight loss, along with reductions in liver fat content, triglycerides, LDL cholesterol, and blood pressure [4]. - The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, with ongoing trials for AUD and ALD [4].

Core Insights - Altimmune, Inc. is presenting findings on pemvidutide, a novel GLP-1/glucagon dual receptor agonist, at the American Diabetes Association's 85 Scientific Sessions, focusing on its potential in treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, alcohol use disorder (AUD), and alcohol-associated liver disease (ALD) [1][4]. Group 1: Presentation Details - The oral presentation titled "Effects of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids in Subjects with Obesity or Overweight" will be held on June 21, 2025, at 5:45 PM CDT [2]. - Three poster presentations will cover topics including cardiovascular safety, non-invasive tests of central adiposity, and cholesterol transport in a hamster model, all scheduled for June 22, 2025 [2]. Group 2: Pemvidutide Overview - Pemvidutide is designed to activate GLP-1 and glucagon receptors, mimicking the effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure [3]. - Clinical trials have shown that pemvidutide leads to significant weight loss, preservation of lean mass, and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure [4]. Group 3: Regulatory Status and Trials - The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, with the MOMENTUM Phase 2 obesity trial completed in 2024 and ongoing IMPACT Phase 2b MASH trial expected to report top line results in Q2 2025 [4]. - IND applications for AUD and ALD have received FDA clearance, with the Phase 2 trial for AUD starting in Q2 2025 and the ALD trial set to begin in Q3 2025 [4]. Group 4: Company Background - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases, with pemvidutide as its lead program [5].

Summary of Altimmune (ALT) 2025 Conference Call Company Overview - **Company**: Altimmune, focusing on treatments for metabolic diseases, particularly NASH (Non-Alcoholic Steatohepatitis) and obesity [1][2] Key Industry Insights - **NASH and Obesity**: The company emphasizes the dual approach of treating both NASH and obesity, as a significant percentage (80-90%) of NASH patients are either obese or overweight [6][29] - **Pembutide**: A dual receptor agonist (GLP-1 and glucagon) that targets both liver health and weight loss, positioning it uniquely in the market [5][7] Core Points and Arguments - **Phase Two Data**: Anticipation for the upcoming Phase Two data readout, which is expected to demonstrate significant efficacy in treating NASH and obesity [4][26] - **Placebo Effect Management**: The company is implementing rigorous methodologies to minimize the placebo effect in trials, including a three-panel read for biopsy analysis [15][17] - **Statistical Analysis**: Plans to present data using ITT (Intention to Treat), completer analysis, and imputation methods to provide a comprehensive view of treatment efficacy [19][21] - **Endpoints**: Focus on three primary endpoints: weight loss, NASH resolution, and fibrosis improvement, with expectations of statistical significance across all [26][34] Financial Position - **Cash Reserves**: Altimmune reported $150 million in cash, sufficient to fund operations through the end of 2026, supporting the Phase Three program initiation [50][54] Future Development Plans - **Phase Three Design**: The company is preparing for a Phase Three trial that will emphasize early efficacy indicators and potentially reduce patient numbers required for NDA submissions [48][56] - **Partnership Strategy**: While open to partnerships, Altimmune is prepared to advance its NASH program independently, focusing on the serious nature of the disease rather than entering the competitive obesity market alone [54][57] Additional Indications - **Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD)**: Altimmune is pursuing trials for AUD and ALD, which share similar pathophysiological characteristics with NASH. The market for these conditions is largely untapped, with only 2% of AUD patients currently receiving treatment [60][68] Market Opportunity - **Unmet Medical Need**: Both AUD and ALD represent significant market opportunities due to the lack of effective treatments and the high prevalence of these conditions [68][69] Conclusion - Altimmune is strategically positioned to address significant unmet needs in the metabolic disease space, with a strong focus on innovative treatment approaches and a robust financial foundation to support its development pipeline [50][68]

Core Insights - Pfizer has decided to discontinue the development of Danuglipron due to safety concerns and is now looking for business development opportunities to acquire promising product candidates [1] Group 1: Company Actions - Pfizer is actively seeking to acquire new product candidates following the halt of Danuglipron's development [1] Group 2: Analyst Background - The analyst has over 20 years of experience in research and development of novel Cell & Gene Therapies, focusing on assessing the potential of new treatments and their ability to generate shareholder returns [1]

Group 1 - Altimmune Inc. (ALT) is preparing for the readout from the IMPACT phase 2b study of pemvidutide, which targets metabolic dysfunction-associated steatohepatitis (MASH) [1] - The analyst rated ALT as a buy in December 2024, based on pemvidutide's profile and the company's valuation [1] - The focus is on trading around significant events such as trial results and NDA/BLA approvals, particularly in the biotech sector [1]

Core Insights - ALT5 Sigma Corporation has partnered with Voltage to enable Lightning Network payment capabilities, facilitating instant and low-cost Bitcoin transactions for global merchants and financial institutions [1][2][3] Company Overview - ALT5 Sigma is a fintech company focused on blockchain-powered payment and trading infrastructure, processing over $5 billion in cryptocurrency transactions since its inception [6][7] - The company offers two main platforms: ALT5 Pay, a cryptocurrency payment gateway, and ALT5 Prime, an electronic over-the-counter trading platform [8][9] Industry Trends - The integration of Lightning Network is seen as a strategic move to meet the growing demand for faster settlement and lower fees in the digital economy [2][3] - There is an increasing interest in stablecoin settlement over Lightning, presenting new opportunities for financial platforms [4] Technological Advancements - The Lightning Network integration allows for real-time Bitcoin transactions, enhancing speed, reliability, and cost-efficiency for high-frequency digital payments [3] - ALT5's infrastructure aims to provide scalable and secure solutions for bridging digital assets with traditional financial workflows [5]

Financial Data and Key Metrics Changes - The company is preparing for a significant data readout for its NASH drug candidate, pemidutide, expected by the end of the current quarter, which is crucial for future development plans [27][20]. - The highest dose in the MOMENTUM trial showed a weight loss of 15.6% at 48 weeks, indicating strong efficacy compared to competitors [30]. Business Line Data and Key Metrics Changes - The company is focusing on the dual mechanism of action of pemidutide, which combines weight loss with direct effects on liver health, positioning it uniquely in the market [15][18]. - The upcoming Phase 2b trial for NASH is designed to control placebo responses, which have been problematic in previous trials, aiming for a more accurate assessment of drug efficacy [12][14]. Market Data and Key Metrics Changes - NASH is now the leading cause of liver transplantation in the U.S., with a growing prevalence linked to the obesity epidemic, highlighting a significant unmet medical need [10][11]. - The company is expanding its pipeline to include Alcohol Use Disorder (AUD) and Alcoholic Liver Disease (ALD), both of which have critical unmet needs and overlap with obesity-related conditions [38][42]. Company Strategy and Development Direction - The company aims to treat serious conditions resulting from obesity rather than pursuing a pure obesity indication, which is becoming increasingly competitive and price-sensitive [36][39]. - The strategy includes leveraging a large safety database from previous trials to support the development of AUD and ALD treatments, enhancing the overall market opportunity [43][41]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readout and the potential for a Phase III program to start in early 2026, contingent on positive results [20][40]. - The company believes that the combination of metabolic and liver health benefits will allow it to cover a broad spectrum of patients with NASH and related conditions, improving treatment options [60][61]. Other Important Information - The company has noted that the weight loss profile of pemidutide is expected to be comparable to semaglutide at 48 weeks, with potential for even greater efficacy beyond that timeframe [24][25]. - The design of the IMPACT trial includes unique features aimed at controlling placebo responses, which could lead to more reliable results [12][14]. Q&A Session Summary Question: Can you tell us about the unmet need in NASH? - Management highlighted that there is only one approved drug for NASH with modest effects, and the condition is increasingly prevalent due to obesity, creating a significant need for more effective treatments [10][11]. Question: What are the expectations around the upcoming Phase 2b trial? - The company plans to have its end of Phase 2 meeting after the 24-week readout, focusing on the primary endpoint of biopsy results at that time [20][21]. Question: How does the company view the competitive landscape for obesity treatments? - Management indicated that the obesity market is changing, and the company is focusing on serious diseases related to obesity rather than solely on obesity itself, which is becoming a price-sensitive market [36][39]. Question: What are the key differentiators of pemidutide compared to other treatments? - The company believes that pemidutide's dual action of promoting weight loss while directly affecting liver health sets it apart from other drugs in development [15][18]. Question: What is the timeline for the AUD and ALD studies? - The AUD study has just started, and initial data readouts are expected by the end of next year, with the ALD study anticipated to begin in the third quarter [45][41].

Core Insights - Altimmune, Inc. has initiated the RECLAIM Phase 2 trial for pemvidutide, targeting Alcohol Use Disorder (AUD) [1][2] - Pemvidutide is a dual receptor agonist aimed at treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD, and alcohol liver disease (ALD) [1][4] - The trial will enroll approximately 100 subjects and assess changes in alcohol consumption and related biomarkers [2][3] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on peptide-based therapeutics for liver and cardiometabolic diseases [4] - The lead program, pemvidutide, is designed to address multiple conditions including MASH, obesity, AUD, and ALD [4] Industry Context - Over 28 million individuals in the U.S. are affected by AUD, with less than 10% currently receiving treatment [3] - Existing medications for AUD have limited effects and compliance rates, highlighting the need for new therapies [3] - Pemvidutide has shown promising preclinical results, significantly reducing alcohol preference in animal models [3]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-32587 ALTIMMUNE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 20-2726770 (State or Oth ...

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]