Summary of Structure Therapeutics Conference Call on Eleniglipron Company Overview - **Company**: Structure Therapeutics (NasdaqGM: GPCR) - **Product**: Eleniglipron, an oral small molecule GLP-1 receptor agonist - **Focus**: Chronic weight management and obesity treatment Key Industry Insights - **Obesity Market**: - Current injectable peptides serve approximately 5 million people in the U.S., a small fraction of over 100 million people living with obesity or overweight [5][4] - By 2030, around 1.5 billion people globally are expected to be living with obesity or overweight [5] - **Need for Oral Medications**: - Oral small molecules like Eleniglipron can scale to meet the needs of the global patient population [6] Core Findings from Clinical Trials - **ACCESS Phase 2b Study Results**: - At 36 weeks, patients on Eleniglipron experienced placebo-adjusted weight loss of: - 8.2% (45 mg) - 9.8% (90 mg) - 11.3% (120 mg) [7] - In the exploratory ACCESS 2 study, patients on the 120 mg dose experienced a 14.1% placebo-adjusted weight loss [8] - Higher doses (180 mg and 240 mg) showed even greater weight loss of 14.4% and 15.3%, respectively [8] - No evidence of weight loss plateau beyond 36 weeks [8] - **Safety and Tolerability**: - Overall treatment discontinuation rate due to adverse events was 10.4% [9] - No events of drug-induced liver injury reported among over 500 patients treated [10] - Nausea peaked early in the titration phase but remained below 10% by the end of the study [17][19] - Improved tolerability observed with a lower starting dose of 2.5 mg, showing no treatment discontinuations in the first 10 weeks [34][39] Future Development Plans - **Phase 3 Readiness**: - Structure Therapeutics is preparing to move into Phase 3 trials, with an anticipated mid-2026 first patient in [40] - Plans to initiate Phase 3 studies using a 2.5 mg starting dose based on improved tolerability data [41] - **Combination Therapies**: - Eleniglipron is positioned as a backbone for future oral combination therapies [6] - Structure Therapeutics is also developing amylin-targeted molecules and exploring potential indications beyond obesity [42][43] Market Positioning - **Target Audience**: - Focus on primary care physicians and non-specialists who seek effective, convenient, and accessible treatment options for obesity [41] - **Competitive Advantage**: - Eleniglipron's oral formulation and favorable safety profile position it as a potential best-in-class option in the growing chronic weight management market [41] Upcoming Catalysts - **2026 Milestones**: - End of Phase 2 meeting with the FDA - Top-line results from ongoing studies - Initiation of pivotal Phase 3 studies for Eleniglipron [44][45] Conclusion - Eleniglipron demonstrates significant potential in the obesity treatment landscape, with compelling efficacy and a favorable safety profile, setting the stage for its advancement into Phase 3 clinical trials and broader market introduction.

Core Viewpoint - Novo Nordisk has submitted a supplemental marketing application to the FDA for a higher dose of semaglutide injection (7.2 mg) aimed at chronic weight management, with expectations for regulatory decisions in various regions, including the EU by Q1 2026 [1][2]. Group 1: Application Details - The application includes results from the STEP UP trial, a 72-week phase 3 study that assessed the efficacy and safety of semaglutide 7.2 mg against placebo and semaglutide 2.4 mg in 1,407 adults with obesity [3]. - Patients with diabetes were excluded from the trial [3]. Group 2: Trial Results - Participants treated with semaglutide 7.2 mg experienced an average weight loss of 20.7% after 72 weeks, compared to 17.5% for semaglutide 2.4 mg and 2.4% for placebo, starting from a mean baseline weight of 249 pounds [4]. - 33.2% of patients on semaglutide 7.2 mg achieved a weight loss of 25% or more, compared to 16.7% for semaglutide 2.4 mg and 0.0% for placebo [4]. Group 3: Additional Findings - When including participants who discontinued, those on semaglutide 7.2 mg achieved an 18.7% weight loss, while semaglutide 2.4 mg and placebo resulted in 15.6% and 3.9% weight loss, respectively [5]. - 90.7% of participants on semaglutide 7.2 mg achieved at least a 5% reduction in body weight, compared to 89.9% for semaglutide 2.4 mg and 36.8% for placebo [5]. - 31.2% of those receiving semaglutide 7.2 mg achieved a weight loss of 25% or more, compared to 15.3% for semaglutide 2.4 mg and 0.0% for placebo [6]. Group 4: Market Reaction - Following the news, Novo Nordisk shares rose by 3.77%, reaching $48.83 at the time of publication [6].

Core Insights - Vivani Medical, Inc. has successfully initiated the LIBERATE-1 study for its NPM-115 (exenatide implant) with full enrollment achieved, expecting top-line data in mid-2025 [1][4] - The company reported promising preclinical data for NPM-139 (semaglutide implant), indicating potential for once-yearly dosing comparable to existing treatments [1][3] - An additional $8.25 million in equity financing has been secured, ensuring financial stability into Q2 2026 to support ongoing development of NPM-115 and NPM-139 [1][3] Company Developments - Vivani transitioned to a clinical-stage biotechnology company in 2024, achieving significant milestones in its NPM-115 and NPM-139 programs [2] - The LIBERATE-1 study has successfully administered its first GLP-1 implant, addressing medication adherence challenges in chronic weight management and type 2 diabetes [4] - The company is advancing NPM-139 towards clinical phase development alongside the ongoing NPM-115 program [2][3] Financial Performance - As of December 31, 2024, Vivani reported a cash balance of $19.7 million, down from $22.0 million in 2023, primarily due to a net loss of $23.5 million [10] - Research and development expenses for Q4 2024 were $4.3 million, a decrease of 9% from $4.7 million in Q4 2023 [11] - General and administrative expenses increased by 43% to $2.1 million in Q4 2024 compared to $1.5 million in Q4 2023, attributed to higher professional services and stock-based compensation [12] Future Outlook - Key milestones for the LIBERATE-1 trial are anticipated, including the last subject implanted and top-line results expected in mid-2025 [15] - Vivani plans to file an Investigational New Drug Application for NPM-139 and advance its clinical trials [15] - The company is also preparing for the spin-off of its subsidiary Cortigent into an independent publicly traded company [5][15]