Summary of Altimmune Conference Call Company and Industry - **Company**: Altimmune - **Industry**: Pharmaceutical/Biotechnology, specifically focusing on liver diseases such as MASH (Metabolic Associated Steatotic Liver Disease) Key Points and Arguments 1. **IMPACT Phase 2b Trial Results**: The 48-week data from the IMPACT trial of Pembidutide in MASH showed significant improvements in non-invasive markers of fibrosis, with continued reductions from the 24-week time point [4][21] 2. **Weight Loss**: The 1.8-milligram dose of Pembidutide resulted in additional weight loss from 24 to 48 weeks, with no evidence of plateauing [4][21] 3. **FDA Engagement**: Altimmune had a productive end-of-phase 2 meeting with the FDA, aligning on the registration of the phase 3 program for MASH patients with moderate to advanced fibrosis [17][18] 4. **Tolerability Profile**: Pembidutide demonstrated a favorable tolerability profile, critical for maintaining patients on therapy, especially in a chronic disease setting like MASH [15][16] 5. **Dose Response**: The data indicated a clear dose response, supporting the focus on the 1.8-milligram dose for phase 3 trials, with potential for a 2.4-milligram maintenance dose [8][15] 6. **Comparison with Other Therapies**: Pembidutide's improvements in ELF and liver stiffness measurements were favorable compared to currently approved therapies like Resmetirom and Semaglutide [12][13] 7. **Safety Profile**: No serious adverse events were reported, and the majority of adverse events were mild to moderate, with good glycemic control maintained in diabetic patients [15][16] 8. **Regulatory Strategy**: The primary endpoint for the phase 3 trial will be biopsy-driven, but there is potential for incorporating non-invasive tests (NITs) as the FDA's stance evolves [42][43] 9. **Sample Size for Phase 3**: The expected sample size for the phase 3 trial is between 1,000 to 1,500 patients, with discussions ongoing with the FDA [40][41] 10. **Future Plans**: Altimmune plans to initiate the phase 3 MASH trial in 2026, with additional trials for other indications like AUD (Alcohol Use Disorder) and ALD (Alcoholic Liver Disease) [20][21] Other Important but Overlooked Content 1. **AI Tool Utilization**: The FDA is open to incorporating the AIM-MASH AI pathology tool to improve standardization in biopsy readings, which could reduce variability in the consensus read process [18][43] 2. **Long-term Outcomes**: The phase 3 study will follow patients for up to 60 months to assess liver-related events, with potential for future studies in F4 populations [41] 3. **Market Research Insights**: Payers are increasingly focused on early response indicators and adherence to chronic therapies, which could influence reimbursement decisions [38][39] 4. **Differentiation from Competitors**: Pembidutide's unique mechanism and tolerability profile may provide a competitive edge over existing therapies in the market [28][29] This summary encapsulates the critical insights from the Altimmune conference call, highlighting the company's advancements in the treatment of MASH and its strategic direction moving forward.

整理 | GLP1减重宝典内容团队 相关专家指出，MASH研究正处于快速推进阶段。随着获批治疗手段的增多，AASLD正致力于向临床提供及时且实用的方案，帮助医 生基于证据选择合适的患者，并确保安全性和疗效监测。 今年六月，诺和诺德表示美国食品药品监督管理局（FDA）已授予其减重药物Wegovy加速批准，用于治疗代谢功能障碍相关脂肪性肝炎 （MASH），这是一种严重的肝脏疾病。此举巩固了该公司在代谢疾病领域的地位。 "该领域几乎没有可用的有效治疗方法。我们现在是仅有的两种FDA批准的MASH疗法之一，患者确实需要能够改善获益风险平衡并延缓甚 至阻止疾病进展的药物，"诺和诺德美国医学事务主管Jason Brett在接受采访时表示。 《HEPATOLOGY》中发布了最新版的实践指南，重点聚焦司美格鲁肽在MASH治疗中的应用。 MASH是一种慢性肝脏疾病，其特征是肝脏脂肪堆积过多，并与多种代谢风险高度相关，包括肥胖、2型糖尿病、高血压以及高胆固醇 等。新指南面向临床团队，为中度到进展期纤维化（F2-F3阶段）的患者使用司美格鲁肽治疗提供建议。内容结合了最新试验数据（包 括ESSENCE研究）以及最新的监管批准，并整合 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The report highlights the significant market potential for Metabolic Associated Steatotic Liver Disease (MASH), with an expected patient population of 56 million in China and 490 million globally by 2030. The market for MASH-related drugs is projected to reach 35.5 billion RMB in China and 32.2 billion USD globally by the same year [5][15]. - The report emphasizes the promising clinical results of East China Pharmaceutical's DR10624 for treating severe hypertriglyceridemia (SHTG), showing a maximum triglyceride reduction of 74.5% and liver fat reduction of 67% during a 12-week treatment period [6][32]. Summary by Sections Section 1: FGF21 Target and Investment Opportunities - FGF21 is identified as a key target for MNCs, with a focus on its role in regulating lipid metabolism and preventing fibrosis. The report notes that several global pharmaceutical companies are actively developing FGF21-related therapies [5][19]. - The report details the competitive landscape, with multiple FGF21 candidates in various clinical stages, including East China Pharmaceutical's DR10624, which is in Phase II trials for MASH [20][34]. Section 2: Market Performance - In the second week of November, the pharmaceutical and biotechnology sector rose by 3.29%, outperforming the CSI 300 index by 4.37 percentage points, ranking fifth among 31 sub-industries [7][36]. - The report indicates that the pharmaceutical distribution sector had the highest increase, up by 5.92%, while the medical equipment sector saw the smallest rise at 0.04% [39][42]. Section 3: Monthly Recommendations - The report recommends a monthly investment portfolio focusing on innovative drugs and their supply chains, suggesting stocks such as Sanofi, Innovent Biologics, and WuXi Biologics among others [7][8].

Financial Data and Key Metrics Changes - For Q3 2025, net sales totaled $287.3 million, representing a 35% increase quarter over quarter [23][24]. - The company ended Q3 2025 with $1.1 billion in cash and marketable securities, reflecting a strong cash position to support ongoing operations [25][26]. Business Line Data and Key Metrics Changes - Rezdiffra's sales are annualizing at over $1 billion within six quarters of launch, with over 29,500 patients currently on the therapy, up from more than 23,000 at the end of Q2 2025 [4][6][7]. - The number of prescribers for Rezdiffra exceeded 10,000, indicating strong physician penetration [8]. Market Data and Key Metrics Changes - The target population for Rezdiffra is 315,000 diagnosed patients, with a significant portion remaining untreated, providing substantial growth potential [7][10]. - The company is expanding its market presence in Europe, having launched in Germany following European approval [4][15]. Company Strategy and Development Direction - The company aims to maximize the value of Rezdiffra while building its pipeline, focusing on first-line access and payer contracting strategies for 2026 [4][12]. - The strategy includes expanding the pipeline with new assets, such as an oral GLP-1, to enhance treatment options for MASH [17][18]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Rezdiffra's growth potential, citing its best-in-class profile and the expected impact of payer agreements starting January 1, 2026 [11][24]. - The management team highlighted the importance of sustained efficacy and tolerability for long-term chronic use of Rezdiffra [72][75]. Other Important Information - R&D expenses for Q3 2025 were $174 million, primarily due to a one-time expense related to the licensing agreement for MGL-2086 [24][25]. - SG&A expenses increased to $209.1 million, reflecting higher commercial investments to support the Rezdiffra launch [25]. Q&A Session Summary Question: How could AASLD data further de-risk Maestro NASH outcomes? - Management expressed excitement about AASLD and noted positive feedback from gastroenterologists regarding Rezdiffra's efficacy, which gives confidence in the Maestro outcomes trial [30][31][34]. Question: Pros and cons of combining Rezdiffra with MGL-2086 versus other GLP-1s? - Management clarified that MGL-2086 is an orforglipron derivative, emphasizing the rationale for combining it with Rezdiffra to enhance efficacy [37][38]. Question: Thoughts on competitive positioning amid recent M&A in the space? - Management viewed recent M&A as validation of the MASH market and expressed confidence in their long-term strategy and market access [45][46]. Question: Feedback on Rezdiffra's adherence rates and net pricing? - Management confirmed strong adherence rates and indicated that gross-to-net dynamics would likely lead to some future decline in pricing, but they remain optimistic about market access [51][53]. Question: Comments on Aetna's formulary coverage decision? - Management stated that Aetna's decision would not significantly impact access, as Rezdiffra would still be available through prior authorization [59]. Question: Observations on Novo's marketing campaign and path to profitability? - Management noted that while it is early to quantify the impact of Novo's campaign, they are optimistic about the potential for increased diagnoses and emphasized a focus on top-line growth [62][68].

Investment Rating - The report maintains an "Outperform" rating for the industry [8] Core Insights - The report highlights the significant potential of FGF21 as a treatment for MASH (Metabolic Associated Steatotic Liver Disease), with a global patient population potentially reaching nearly 500 million and a market size exceeding $30 billion [5][17] - Recent large-scale business development (BD) deals in the FGF21 space, including Novo Nordisk's $4.7 billion acquisition of Akero Therapeutics and Roche's $3.5 billion acquisition of 89bio, indicate strong interest and investment in this area [5][31] - Key domestic companies to watch include China Biologic Products, Dongyang Sunshine Pharmaceutical, and Huadong Medicine, all of which have promising FGF21-related products in various stages of clinical development [5][31] Summary by Sections 1. Investment Focus on FGF21 - MASH is a common liver disease globally, with a potential patient population of nearly 500 million and a drug market projected to exceed $30 billion [17] - FGF21 shows great promise in addressing core issues of MASH, including significant reductions in liver fat, inflammation improvement, and reversal of fibrosis [23][25] - The global R&D landscape for FGF21 is relatively favorable, with low competition among candidates targeting MASH [25][27] 2. Market Performance Review - The CITIC Pharmaceutical Index rose by 0.3% during the week of September 29 to October 10, 2025, underperforming the CSI 300 Index by 1.2 percentage points [4][42] - Year-to-date, the CITIC Pharmaceutical Index has increased by 23.0%, outperforming the CSI 300 Index by 5.7 percentage points [4][42] - Top-performing stocks during this period included Zhend Medical (+31.8%), Wanbangde (+21.2%), and Changshan Pharmaceutical (+12.9%) [4][59] 3. Clinical Development Highlights - China Biologic Products has a leading position with its single-target FGF21-Fc fusion protein in Phase II clinical trials [31] - Dongyang Sunshine Pharmaceutical's FGF21/GLP-1 fusion protein has shown promising results in reducing liver fat by 47% compared to a 15% reduction in the placebo group [32][34] - Huadong Medicine's multi-target FGF21/GLP-1R/GCGR fusion protein demonstrated a 79% reduction in liver fat in clinical trials, significantly outperforming the placebo [38][40]

Core Insights - The company is introducing lanifibranor as a promising oral therapy for patients with MASH [1][2] - A significant funding round of over $400 million was completed approximately a year ago, enhancing the company's position for the global Phase III NATiV3 trial [2][3] - The company successfully accelerated enrollment for the trial, resulting in over-enrollment, which was announced in April of this year [3]

Core Insights - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and announced four abstract presentations at the upcoming AASLD The Liver Meeting® 2025 [1][6] Presentation Details - The first abstract compares digital images versus glass slides for histopathological evaluation of liver biopsy samples in the NATiV3 study, scheduled for presentation on November 8, 2025 [2][3] - The second abstract discusses continuous digital pathology scoring revealing fibrosis reversal and therapeutic benefits of lanifibranor, with a presentation date of November 9, 2025 [2] - The third abstract highlights high-resolution digital pathology demonstrating antifibrotic and anti-inflammatory effects of lanifibranor in TAA-induced cirrhotic rodent models, also on November 9, 2025 [2] - The fourth abstract combines digital pathology and biomarkers to quantify fibrosis and treatment response to lanifibranor in a TAA-induced cirrhosis model, presented on November 9, 2025 [2] About Lanifibranor - Lanifibranor is Inventiva's lead product candidate, an orally available small molecule that activates all three PPAR isoforms, inducing anti-fibrotic and anti-inflammatory effects [5][6] - It is the only pan-PPAR agonist in clinical development for MASH, with the FDA granting Breakthrough Therapy and Fast Track designations [5] Company Overview - Inventiva is a public company listed on Euronext Paris and NASDAQ, focusing on the research and development of oral small molecule therapies for MASH [6][7]

Summary of Altimmune Conference Call Company Overview - **Company**: Altimmune - **Product**: GLP-1/glucagon dual agonist for MASH (Metabolic Associated Steatotic Liver Disease) and weight loss Key Points Product Development and Efficacy - Altimmune is developing a GLP-1/glucagon dual agonist that targets liver effects and metabolic benefits, showing promising results in a 24-week Phase 2 trial with class-leading MASH resolution and significant weight loss of approximately 6% at 24 weeks [2][3][20] - The drug demonstrated excellent tolerability without dose titration, which is crucial for patient adherence [3][12] - The treatment shows rapid effects on liver health and weight loss, with expectations of continued improvement as treatment progresses [20][23] Regulatory Considerations - The company is preparing for potential FDA approval based on MASH resolution endpoints, with a focus on both traditional biopsy-based and non-invasive tests (NITs) [11][25] - AI-enabled histological assessments for fibrosis are being considered, with positive feedback expected from the FDA in Q4 [8][9][25] - Altimmune plans to incorporate flexibility in trial design to adapt to regulatory changes, potentially moving away from biopsy requirements [25][26] Market Positioning and Competitive Landscape - The recent interest from large pharmaceutical companies in MASH treatments indicates a growing market, with Altimmune positioned to leverage its dual-action therapy [28][30] - The company believes that its single-molecule approach, which combines liver-targeting and metabolic effects, offers a competitive advantage over combination therapies that require multiple drugs [29][34] - Altimmune aims to treat a broad spectrum of patients (F1 to F4) with its drug, addressing both early and late-stage MASH patients [32][33] Financial and Strategic Outlook - Altimmune is focused on improving its balance sheet to fund the Phase 3 trial and is exploring various funding options [39] - The company holds Fast Track status for alcohol use disorder (AUD) and is optimistic about its ongoing trials in this area, with expected readouts in 2026 [36][38] Additional Insights - The company emphasizes the importance of early efficacy in treatment to maintain patient adherence, which is critical given the high discontinuation rates seen with other GLP-1 therapies [16][17] - Altimmune's strategy is to prioritize high-value treatments for complex diseases rather than competing directly in the obesity market, positioning itself as a multifaceted solution provider [38] This summary encapsulates the key insights from the Altimmune conference call, highlighting the company's innovative approach to treating MASH and its strategic positioning in the market.

Core Viewpoint - Inventiva is hosting an analyst and investor event to provide a strategic update ahead of the anticipated Phase 3 topline results for lanifibranor, its lead asset for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [1] Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH [3] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the pivotal Phase 3 NATiV3 clinical trial for adult patients with MASH, a progressive chronic liver disease [3] Event Details - The event will take place on October 8, 2025, from 11:30 am to 2:00 pm ET in New York City, with a live webcast available [1] - The program will include presentations from Inventiva's leadership and insights from key opinion leaders in the MASH field, along with a patient representative [2][5] Key Topics of Discussion - An update on lanifibranor ahead of the anticipated Phase 3 NATiV3 topline results expected in the second half of 2026 [5] - A deep dive into lanifibranor's mechanism of action and clinical evidence, including findings from the Phase 2b trial [6] - Discussion on the design and objectives of the ongoing Phase 3 study, including patient baseline characteristics [6] - Insights from renowned experts in the field, including Dr. Nezam Afdhal, Dr. William Alazawi, Henry E. Chang, and Dr. Arun Sanyal [6]

Core Viewpoint - The GLP-1 drug market is experiencing rapid growth, with sales expected to exceed $50 billion in 2024, driven by the success of drugs like semaglutide, which generated $16.632 billion in sales in the first half of this year, surpassing competitors [1][10] Market Dynamics - The Hong Kong market has seen significant interest in GLP-1 drugs, with companies like Pague Bio experiencing stock price surges, reflecting investor enthusiasm for this sector [1][2] - Pague Bio's stock price reached a new high of HKD 43.28, pushing its market capitalization over HKD 16 billion, positioning it as a potential leader in the innovative weight-loss drug market [2] Company Innovations - Pague Bio has developed a proprietary platform for drug discovery, focusing on chronic diseases, which includes a drug design platform that enhances drug stability and reduces research costs [4] - The company is advancing its lead candidate PB-119 and another promising candidate PB-718, which is a dual receptor agonist targeting GLP-1 and GCGR, showing potential for significant metabolic improvements [5][9] Clinical Developments - Recent clinical trial results for PB-718 demonstrated a 57.14% reduction in liver fat content over 18 weeks, outperforming semaglutide's results in a similar context [7][8] - The MASH (metabolic dysfunction-associated steatotic liver disease) market is projected to reach $100 billion by 2030, with a significant unmet need for effective treatments [6][9] Competitive Landscape - The global GLP-1 market is highly competitive, with Novo Nordisk and Eli Lilly leading the charge, but Eli Lilly's tirzepatide is showing stronger growth, indicating a shift in market dynamics [10][11] - Pague Bio's innovative products, particularly PB-718, are well-positioned to capitalize on the growing demand in the MASH treatment space, potentially reshaping the market landscape [13][14] Future Outlook - The ongoing development of Pague Bio's products, combined with favorable macroeconomic conditions and policy updates in the pharmaceutical sector, suggests a strong potential for growth and market expansion [14]