Core Viewpoint - Investors are expected to focus on Altimmune's progress with its lead pipeline candidate, pemvidutide, during the second-quarter 2025 results announcement, as the company currently lacks a marketed drug and is projected to report a loss of 32 cents per share [1][10]. Group 1: Pipeline Candidate and Clinical Trials - Pemvidutide is a novel, peptide-based GLP-1/glucagon dual receptor agonist being developed for obesity, metabolic dysfunction-associated steatohepatitis (MASH), alcohol liver disease (ALD), and alcohol use disorder (AUD) [2]. - The phase IIb IMPACT study showed that at 24 weeks, 59.1% and 52.1% of participants receiving pemvidutide 1.2 mg and 1.8 mg achieved MASH resolution without worsening fibrosis, compared to 19.1% with placebo [3]. - Fibrosis improvement without worsening MASH was observed in 31.8% and 34.5% of participants receiving pemvidutide 1.2 mg and 1.8 mg, respectively, versus 25.9% with placebo, although these differences were not statistically significant [4]. Group 2: Weight Loss and Safety Profile - Participants receiving pemvidutide experienced an average weight loss of 5% with the 1.2 mg dose and 6.2% with the 1.8 mg dose, compared to 1% in the placebo group at 24 weeks, indicating a favorable weight loss profile [5]. - Treatment with pemvidutide was generally safe and well-tolerated, which is a positive aspect for its future development [5]. Group 3: Market Performance and Future Expectations - Year to date, Altimmune's shares have declined by 43%, contrasting with a 7.2% increase in the industry [5]. - The company has initiated two separate phase II studies for pemvidutide targeting AUD and ALD, with further updates expected during the upcoming earnings call [6][7]. - Operating expenses are anticipated to have decreased in the upcoming quarter due to the timing of clinical study costs [7]. Group 4: Earnings Surprise History - Altimmune has a mixed earnings surprise history, having beaten estimates in three of the last four quarters, with an average surprise of 9.21% [8]. - In the last reported quarter, the company posted an earnings surprise of 25.71% [8].

Core Insights - Altimmune, Inc. has initiated the RESTORE Phase 2 trial for pemvidutide, targeting Alcohol-Associated Liver Disease (ALD) [1][2] - Pemvidutide is a dual receptor agonist aimed at treating various liver and cardiometabolic diseases, including Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Alcohol Use Disorder (AUD) [1][4] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [5] - The lead program, pemvidutide, is designed to address MASH, AUD, ALD, and obesity [5] Clinical Trial Details - The RESTORE trial will enroll approximately 100 patients across 34 sites, with a 1:1 randomization to receive either 2.4mg pemvidutide or placebo for 48 weeks [2] - The primary endpoint is the change in liver stiffness measurement (LSM) at Week 24, with key secondary endpoints including changes in LSM at Week 48 and alcohol consumption [2] Pemvidutide Efficacy - Previous trials, including the IMPACT Phase 2b trial, demonstrated significant reductions in liver fat, body weight, and liver stiffness, supporting the potential efficacy of pemvidutide [3][4] - Pemvidutide has shown class-leading tolerability with low rates of discontinuation due to adverse events [4] Market Need - There are currently no approved treatments for ALD, and over 6 million Americans with Alcohol Use Disorder have progressed to this condition, highlighting the urgent need for effective therapies [3]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Altimmune, Inc. and its officers or directors following the release of trial results that led to a significant drop in the company's stock price [1][3]. Group 1: Company Overview - Altimmune, Inc. is a publicly traded company on NASDAQ under the ticker symbol ALT [1]. - The company recently announced "topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH)" [3]. Group 2: Trial Results - The trial results were described as "positive," but the key efficacy endpoint showed fibrosis improvement rates of 31.8% and 34.5% for pemvidutide doses of 1.2 mg and 1.8 mg, respectively, compared to 25.9% for placebo, with differences not being statistically significant [3]. - Following the announcement of these results, Altimmune's stock price fell by $4.10 per share, representing a decline of 53.18%, closing at $3.61 per share on June 26, 2025 [3]. Group 3: Legal Investigation - Pomerantz LLP is conducting an investigation on behalf of investors regarding potential securities fraud or other unlawful practices by Altimmune and its management [1]. - The firm has a long history in corporate, securities, and antitrust class litigation, having recovered numerous multimillion-dollar damages awards for victims of securities fraud [4].

Core Viewpoint - Altimmune, Inc. is under investigation for potential securities fraud following the release of mixed results from a clinical trial, which led to a significant drop in its stock price [1][2]. Group 1: Investigation and Legal Context - Pomerantz LLP is investigating claims on behalf of investors of Altimmune regarding possible securities fraud or unlawful business practices by the company and its officers or directors [1]. - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud [3]. Group 2: Clinical Trial Results and Market Reaction - On June 26, 2025, Altimmune announced "topline results" from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), describing the results as "positive" [2]. - The trial reported fibrosis improvement rates of 31.8% and 34.5% for pemvidutide doses of 1.2 mg and 1.8 mg, respectively, compared to 25.9% for placebo, with the differences not being statistically significant [2]. - Following the announcement, Altimmune's stock price fell by $4.10, or 53.18%, closing at $3.61 per share on the same day [2].

Core Insights - Altimmune, Inc. released topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), a severe liver disease [1] Group 1: Trial Details - The Phase 2b trial included 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses, or placebo for 24 weeks [2] - Treatment discontinuation rates were low, with only 9% of participants prematurely discontinuing treatment [3] Group 2: Efficacy Results - In an intent-to-treat (ITT) analysis, the proportions of participants achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% for pemvidutide 1.2 mg, 52.1% for 1.8 mg, and 19.1% for placebo (p< 0.0001 for both doses) [3] - The effects on fibrosis improvement without worsening of MASH were 31.8% for pemvidutide 1.2 mg, 34.5% for 1.8 mg, compared to 25.9% for placebo, although these differences were not statistically significant [4] Group 3: Analyst Ratings - HC Wainwright reiterated a Buy rating for Altimmune with a price forecast of $12, believing the data supports advancing pemvidutide to Phase 3 and strengthens its case as a potential best-in-class therapy [5] - Conversely, William Blair maintained a Market Perform rating, citing "underwhelming" results and concerns about demonstrating significant fibrosis improvement at the 48-week mark [6] Group 4: Stock Performance - ALT stock is trading lower by 1.80% to $3.545 at last check [7]

Group 1 - Altimmune, Inc. (NASDAQ: ALT) is competing in the metabolic disease drug development sector against major pharmaceutical companies like Novo Nordisk (NVO) and Eli Lilly (LLY) [1] - The article highlights the significance of innovative companies in developing breakthrough therapies and pharmaceuticals that have potential acquisition catalysts [1] Group 2 - The author of the article is a full-time healthcare investor with a focus on biotech and life-saving therapies, emphasizing the importance of understanding the market dynamics in this sector [1]

Core Insights - Holzer & Holzer, LLC is investigating whether Altimmune, Inc. complied with federal securities laws following the announcement of topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) [1] - The trial results indicated that there was no statistical significance in improving fibrosis without worsening MASH, leading to a decline in Altimmune's stock price [1] Company Overview - Altimmune, Inc. is a publicly traded company on NASDAQ under the ticker symbol ALT [1] - The company is currently facing scrutiny regarding its compliance with federal securities laws due to the recent trial results [1] Legal Context - Holzer & Holzer, LLC is a law firm that specializes in representing shareholders and investors in litigation, including class action and derivative litigation [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Altimmune (ALT) Conference Call Summary - June 26, 2025 Company and Industry Overview - **Company**: Altimmune, Inc. - **Industry**: Biopharmaceuticals, specifically focusing on treatments for metabolic dysfunction associated with steatohepatitis (NASH) Key Points and Arguments 1. **IMPACT Phase 2b Trial Results**: The conference call focused on the top-line results from the IMPACT Phase 2b trial of pembidutide in NASH, highlighting significant findings related to NASH resolution and fibrosis improvement [7][8][29] 2. **Trial Design**: A total of 212 subjects were enrolled with three treatment arms: placebo, pembidutide 1.2 mg, and pembidutide 1.8 mg, administered weekly for 48 weeks. The primary endpoints were assessed via liver biopsy at 24 weeks [10][11] 3. **NASH Resolution Rates**: Pembidutide achieved a NASH resolution rate of 59.1% compared to 19.1% for placebo, indicating a highly significant treatment effect [14][30] 4. **Fibrosis Improvement**: Although positive trends in fibrosis improvement were observed, statistical significance was not achieved. The absolute fibrosis improvement was 34.5% for the 1.8 mg dose, similar to other candidates [17][29] 5. **Weight Loss**: Significant weight loss of up to 6.2% was reported at the 1.8 mg dose at 24 weeks, with the potential for greater weight loss with a higher dose of 2.4 mg [23][30] 6. **Safety and Tolerability**: The trial demonstrated a low discontinuation rate due to adverse events, with rates less than placebo, indicating a favorable safety profile [25][30] 7. **AI-Based Analyses**: AI-based readings showed significant reductions in fibrosis, suggesting that longer treatment durations could yield statistically significant results for fibrosis improvement [19][29] 8. **Regulatory Pathway**: The data positions pembidutide favorably for Phase III success and potential regulatory approval, with expectations of achieving statistical significance in both NASH resolution and fibrosis improvement [29][30] Additional Important Content 1. **Placebo Response**: The conference discussed the high placebo response rates observed in the trial, which were attributed to the methodology used in biopsy readings. The team is considering alternative methods for Phase III to mitigate this response [46][52] 2. **Future Trials**: Plans for Phase III trials are underway, with discussions about potentially using a higher dose of 2.4 mg and innovative designs to accelerate enrollment [84][86] 3. **Comparative Positioning**: Pembidutide is positioned as a highly differentiated product in the NASH market due to its combination of NASH resolution, weight loss, and favorable tolerability compared to other treatments like semaglutide and tirzepatide [96][98] 4. **Market Potential**: The call emphasized the high prevalence of NASH and the need for effective treatments, positioning pembidutide as a potential foundational therapy in this space [38][76] This summary encapsulates the critical findings and discussions from the Altimmune conference call, providing insights into the company's progress and future directions in the treatment of NASH.

Efficacy Highlights - Pemvidutide demonstrated statistically significant MASH resolution without worsening of fibrosis, reaching up to 59.1% at 24 weeks[55] - Fibrosis improvement without worsening of MASH was observed in up to 34.5% of patients at 24 weeks[55] - Liver fat content was reduced by up to 62.8%[55] - Patients experienced weight loss of up to 6.2% which continued through 24 weeks without plateauing[55] Safety and Tolerability - The trial showed potentially best-in-class tolerability with a low discontinuation rate of less than 1% due to adverse events in subjects receiving pemvidutide[55] - There were no heart rate increases or differences in cardiac adverse events between the pemvidutide and placebo groups[55] Additional Benefits - Pemvidutide maintained HbA1c levels regardless of diabetes status[55] - The trial observed statistically significant improvements in non-invasive tests of fibrosis[55] - Alanine Aminotransferase (ALT) was significantly reduced in ITT Analysis, with reductions of -34.4 IU/L in the 1.2 mg group and -34.6 IU/L in the 1.8 mg group compared to -10.0 IU/L in the placebo group[40]