Metabolic Dysfunction - Associated Steatohepatitis (MASH)
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Altimmune (NasdaqGM:ALT) Earnings Call Presentation
2025-11-06 21:00
Altimmune Corporate Overview November 2025 Our Mission: To Revolutionize the Standard of Care for Serious Liver Diseases Forward Looking Statements Safe-Harbor Statement This presentation has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future financial or business performance, conditions, pla ...
Altimmune (NasdaqGM:ALT) Conference Transcript
2025-10-21 12:02
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.
Roche enters into a definitive merger agreement to acquire 89bio, and its phase 3 FGF21 analog for the therapy of moderate to severe MASH
Globenewswire· 2025-09-18 05:00
Core Viewpoint - Roche has entered into a definitive merger agreement to acquire 89bio, Inc., a clinical-stage biopharmaceutical company focused on innovative therapies for liver and cardiometabolic diseases, with the transaction expected to close in Q4 2025 [1][10]. Group 1: Acquisition Details - Roche will commence a tender offer to acquire all outstanding shares of 89bio at a price of US$14.50 per share in cash, plus a non-tradeable contingent value right (CVR) for milestone payments of up to US$6.00 per share, representing a total equity value of approximately US$2.4 billion and a total deal value of up to US$3.5 billion [5][8]. - The acquisition price represents a premium of approximately 52% to 89bio's 60-day volume-weighted average price (VWAP) as of September 17, 2025 [5]. Group 2: Strategic Rationale - The acquisition enhances Roche's portfolio in cardiovascular, renal, and metabolic diseases (CVRM) and provides opportunities for future combination development with existing programs [2][3]. - Pegozafermin, 89bio's lead candidate, is positioned to potentially deliver best-in-disease efficacy for moderate to severe Metabolic Dysfunction-Associated Steatohepatitis (MASH) patients, addressing critical unmet needs in this area [3][8]. Group 3: Employee Integration - Current employees of 89bio will join Roche's Pharmaceuticals Division as part of the acquisition [4]. Group 4: Milestone Payments - The non-tradeable CVR will entitle holders to contingent cash payments based on the achievement of specific commercial milestones, including US$2.00 per share upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients by March 31, 2030 [7][17].
Altimmune Announces Second Quarter 2025 Financial Results and Business Update
Globenewswire· 2025-08-12 11:00
Core Insights - Altimmune, Inc. announced positive results from the IMPACT Phase 2b trial for pemvidutide, indicating its potential as a differentiated therapy for Metabolic Dysfunction-Associated Steatohepatitis (MASH) with statistically significant MASH resolution and weight loss at 24 weeks [1][3][11] - The company is preparing for an End-of-Phase 2 Meeting with the FDA, expected in Q4 2025, to discuss the next steps for pemvidutide's development [5][11] - Financial results show a cash position of $183.1 million as of June 30, 2025, reflecting a 39% increase from the previous year [4][8] Clinical Trial Results - The IMPACT Phase 2b trial reported that up to 59.1% of patients receiving pemvidutide experienced statistically significant MASH resolution without worsening fibrosis [4] - Improvements in corrected T1 (cT1), a marker of liver inflammation and fibrosis, were observed, with mean decreases of 145.0 ms and 147.9 ms in the pemvidutide 1.2 mg and 1.8 mg groups, respectively, compared to a decrease of 27.5 ms in the placebo group [4][11] - Statistically significant weight loss of up to 6.2% was recorded at 24 weeks, with a trajectory indicating continued weight loss [4][11] Financial Overview - For the second quarter ended June 30, 2025, Altimmune reported a net loss of $22.1 million, or $0.27 per share, an improvement from a net loss of $24.6 million, or $0.35 per share, in the same period in 2024 [8][17] - Research and development expenses decreased to $17.2 million from $21.2 million year-over-year, attributed to the timing of clinical trial costs [8][17] - General and administrative expenses remained stable at approximately $5.7 million [8][17] Future Developments - The company plans to report full 48-week data from the IMPACT trial in Q4 2025, which will provide further insights into the long-term efficacy and safety of pemvidutide [3][4] - Altimmune has initiated two additional Phase 2 trials: RECLAIM for Alcohol Use Disorder (AUD) and RESTORE for Alcohol-Associated Liver Disease (ALD), both expected to enroll around 100 subjects [9][11]