Summary of Biomea Fusion Conference Call Company Overview - **Company**: Biomea Fusion (NasdaqGS:BMEA) - **Industry**: Biotechnology, focusing on metabolic diseases, specifically diabetes and obesity [14][15] Core Points and Arguments Metabolic Disease Focus - Biomea is positioned in the metabolic space, targeting diabetes and obesity, which are identified as significant health challenges [14][15] - The company aims to address the root causes of diabetes by focusing on insulin deficiency rather than just symptom management [19][20] Product Development - **Icovamenib**: A menin inhibitor designed to regenerate beta cells in the pancreas, targeting insulin-deficient patients [21][22] - The drug aims to provide a more effective treatment for diabetes by addressing the underlying issue of insufficient insulin production [20][21] - **Next-Generation GLP-1 Receptor Agonist**: Biomea is developing an oral GLP-1 receptor agonist based on the orforglipron scaffold, which aims to improve patient compliance and efficacy [23][41] Clinical Trials and Data - The company is preparing for Phase 2 trials, focusing on insulin-deficient patients and those failing GLP-1 therapy [40][41] - Initial data from trials show promising results, with a significant reduction in HbA1c levels and weight loss in patients [27][50] - The company plans to release data in Q1 of the following year, with expectations of enrolling patients quickly [31][41] Safety and Efficacy - Biomea emphasizes a favorable safety profile for icovamenib, with minimal side effects compared to placebo [26][27] - The company has a safety database covering over 400 patients, which is considered sufficient for regulatory discussions with the FDA [44][45] Future Directions - Biomea is exploring additional applications for icovamenib in obesity and Type 1 diabetes, indicating a broader potential for the drug beyond its initial indications [51][57] - The company is focused on refining dosing instructions to minimize variability in trial results [30][36] Important but Overlooked Content - The discussion highlights the innovative approach of icovamenib in directly targeting menin, contrasting with other menin inhibitors that focus on preventing protein interactions, which may lead to side effects [25][26] - The potential for icovamenib to enhance the effects of existing GLP-1 therapies, leading to greater weight loss and improved metabolic outcomes, is a significant point of interest [50][51] - Biomea's strategic focus on a defined patient population (insulin-deficient and GLP-1 failing patients) is crucial for its clinical development and regulatory strategy [39][40]

Financial Data and Key Metrics Changes - For Q3 2025, research and development expenses decreased to $17.5 million from $19.0 million in Q3 2024, primarily due to reduced spending on the Revitalize One study and lower stock-based compensation [17] - Selling, general, and administrative expenses increased to $5.2 million from $4.8 million in the same period last year, reflecting one-time costs associated with the issuance of warrants [17] - The company reported a net loss of $45.6 million, compared to a net loss of $23.2 million in Q3 2024, largely driven by a $23.5 million non-cash accounting change in the fair value of warrants [17] - As of September 30, 2025, cash and cash equivalents stood at approximately $77.7 million, bolstered by $83 million from recent underwritten offerings, extending the cash runway into early 2027 [18] Business Line Data and Key Metrics Changes - Revita, the company's endoscopic procedural therapy, demonstrated significant clinical results, with treated patients losing an additional 2.5% of total body weight while sham group patients regained about 10% after discontinuing tirzepatide [6][8] - Enrollment in the Remain One pivotal cohort was completed in Q2 2025, with over 60% of patients randomized as of October 31, 2025, ahead of schedule [7] Market Data and Key Metrics Changes - The company anticipates nearly 1 million annual procedures at peak adoption for Revita, translating to a substantial revenue opportunity [13] - Revita's unit economics are expected to create strong incentives for adoption at clinical sites, with gross margins comparable to or better than other advanced endoscopic interventions [13] Company Strategy and Development Direction - The company is focused on advancing clinical programs and regulatory milestones, with a clear path for multiple catalysts expected within the next 12 months, including pivotal data and potential PMA submission [19] - Revita is positioned as a transformative therapy for obesity, particularly in post-GLP-1 weight maintenance, complementing existing chronic drug therapies [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical and regulatory milestones, emphasizing the strong data supporting Revita and the growing market need for effective obesity treatments [4][19] - The company is optimistic about the potential for Revita to significantly reduce weight regain rates, which is a critical challenge for patients discontinuing GLP-1 therapies [9][22] Other Important Information - The company has established a ready-to-activate commercial model with experienced physicians at major clinical centers across the U.S. [12] - Revita's durable activity is expected to provide economic advantages by potentially reducing the need for ongoing drug therapy and associated health risks [11] Q&A Session Summary Question: What are the expectations for the six-month updates for Reveal One and Remain One Midpoint? - Management expects the six-month Reveal dataset to show consistency in results, with a goal of less than 5% weight regain, which would be a compelling outcome [21][23] Question: Can you clarify the German registry data regarding weight loss maintenance? - The average weight loss at one year was 8%, and at two years was 8.9%, indicating no waning of effect [26][27] Question: What are the manufacturing needs for Revita? - The company is confident in its current manufacturing capabilities to support clinical studies and is preparing for scale [41]

6 November 2025 | 7:31PM EST Equity Research GLOBAL HEALTHCARE: PHARMACEUTICALS The Obesity Evolution: GLP-1 Pricing Deals Offer Significant Potential Volume Unlock; LLY Advantaged Today, Eli Lilly and Novo Nordisk announced drug pricing deals with the US government which across the portfolio largely echoed deals signed by Pfizer and AstraZeneca, but also included provisions to reduced GLP-1 prices to (1.) c.$350 per month on TrumpRx.com - trending to $245 over time (timeframe not confirmed but our interpre ...

Core Insights - Eli Lilly and Co. has released promising data from a Phase 2 trial of eloralintide, showing significant weight reduction in obese adults with obesity-related health issues [1][2] Group 1: Trial Results - The Phase 2 trial involved 263 obese adults and demonstrated that all treatment arms of eloralintide achieved superior mean weight reductions ranging from 9.5% to 20.1% compared to a mere 0.4% with placebo at 48 weeks [1] - Secondary endpoints also showed clinically meaningful improvements in body weight and body mass index, along with enhancements in cardiometabolic risk factors such as waist circumference, blood pressure, lipid profiles, glycemic control, and inflammation markers [2] Group 2: Analyst Commentary - Analysts believe that the data supports the notion that the amylin agonist class, including eloralintide, will become a key treatment option for chronic obesity management, either as a standalone therapy or in combination with other incretin drugs [3] - Concerns were raised regarding the higher incidence of fatigue associated with eloralintide (21% vs. 12% for other incretin drugs), which could impact patients' quality of life [4] - The trial indicated a directional decrease in pulse rate with eloralintide, differentiating it from other incretin-based drugs, which may alleviate concerns about cardiovascular risks associated with high-potency obesity treatments [5]

"Every patient has a different preference, and we need the products to match that."Novo Nordisk CEO Mike Doustdar tells @GuyJohnsonTV the reason behind the firm's takeover bid for obesity startup Metsera https://t.co/hOTbziTe9e https://t.co/AR35Soh0nt ...

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $90 million, up from $22.8 million in Q3 2024, primarily due to increased clinical study costs and salaries [9] - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs [9] - The net loss for Q3 2025 was $90.8 million or $0.81 per share, compared to a net loss of $24.9 million or $0.22 per share in Q3 2024 [10] - For the first nine months of 2025, research and development expenses were $191.5 million, up from $70.7 million in the same period in 2024 [11] - The net loss for the first nine months of 2025 was $202 million or $1.80 per share, compared to a net loss of $74.5 million or $0.69 per share in the same period in 2024 [11] - Cash, cash equivalents, and short-term investments decreased to $715 million as of September 30, 2025, from $903 million at the end of 2024 [12] Business Line Data and Key Metrics Changes - The company is advancing VK2735, a dual agonist for obesity treatment, with both subcutaneous and oral formulations being developed [13][18] - Positive results were reported from the Phase 2 VENTURE-Oral Dosing Study, achieving significant weight loss and demonstrating safety and tolerability [20][29] Market Data and Key Metrics Changes - The VANQUISH Phase 3 Registration Program is ongoing, targeting enrollment of approximately 4,500 patients for VANQUISH-1 and 1,100 patients for VANQUISH-2 [17] - Enrollment in the VANQUISH studies is proceeding well, with expectations to complete enrollment by the end of 2025 for VANQUISH-1 and in Q1 2026 for VANQUISH-2 [18][28] Company Strategy and Development Direction - The company is focused on advancing VK2735 through clinical trials while managing its financial resources to support multiple value inflection points [27][28] - The strategy includes exploring maintenance dosing regimens to enhance patient adherence and long-term outcomes [26][65] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the ongoing clinical trials and the potential for VK2735 to address obesity effectively [29] - The company is preparing for an end-of-Phase 2 meeting with the FDA to discuss next steps for the oral formulation of VK2735 [25][71] Other Important Information - The company is also advancing novel agonists targeting the amyloid receptor, with plans to file an IND in Q1 2026 [27] - The management highlighted the importance of payer discussions regarding maintenance regimens to improve patient persistence and long-term benefits [65] Q&A Session Summary Question: Early signs of patient persistence in Phase 3 trials - Management noted that enrollment is ahead of schedule and there are no early signs of persistence issues [33] Question: Details on the maintenance study's induction phase - The induction phase will involve titration to doses of 17.5 mg, 20 mg, and 22.5 mg over 19 weeks [34] Question: Doses for monthly subcutaneous and oral maintenance - Monthly doses will range from 15 mg to 22.5 mg, with daily oral doses at 17.5 mg and 27.5 mg [41] Question: Impact of government shutdown on enrollment and timing - Management reported no significant impact from the government shutdown on trial enrollment or FDA communications [51] Question: Future clinical steps for maintenance regimens - A longer study, potentially a Phase 2b or Phase 3, would be considered based on maintenance study results [50] Question: Considerations for screening multiple compounds - Efficacy, toxicity profiles, and compatibility with VK2735 are key considerations in screening [44] Question: Expectations for OpEx spend moving forward - Operating expenses are expected to remain elevated due to ongoing Phase 3 activities [90] Question: Plans for VK2809 partnership - There is ongoing interest in the MASH asset, but no specific partnership plans were disclosed [92] Question: Transitioning from weekly injectable to weekly oral - Management does not anticipate significant tolerability issues when transitioning from subcutaneous to oral formulations [62] Question: Key considerations for the end-of-Phase 2 meeting - Discussions will focus on study design, duration, and leveraging existing safety data for the oral formulation [83]

Core Insights - MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, with key developments in obesity and liver disease treatments [3]. Company Overview - The company is developing DA-1726, a novel oxyntomodulin (OXM) analogue, aimed at treating obesity. It acts as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), potentially leading to superior weight loss compared to selective GLP1R agonists [3]. - DA-1726 has shown best-in-class potential in a Phase 1 multiple ascending dose trial, demonstrating effectiveness in weight loss, glucose control, and waist reduction [3]. - MetaVia is also developing DA-1241, a G-protein-coupled receptor 119 (GPR119) agonist, for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH). Pre-clinical studies indicate its positive effects on liver inflammation, lipid metabolism, weight loss, and glucose metabolism [3]. - In a Phase 2a clinical study, DA-1241 exhibited direct hepatic action alongside glucose-lowering effects, reducing hepatic steatosis, inflammation, and fibrosis [3]. Conference Participation - President and CEO Hyung Heon Kim will present at the H.C. Wainwright Liver Disease Virtual Conference on October 21-22, 2025, with CFO Marshall H. Woodworth participating in one-on-one meetings [1][2].

Business Strategy - Novo Nordisk cut its cell therapy division focused on type 1 diabetes cure [1] - The company is slashing headcount to focus on lucrative areas of obesity and diabetes treatment [1] Industry Focus - The company is prioritizing obesity and diabetes treatment areas [1]

Company Overview - Eli Lilly (NYSE: LLY) is recognized as a leading player in the obesity and type 2 diabetes treatment markets, driven by the approvals of its drugs Zepbound and Mounjaro [2]. Market Opportunities - There are significant expansion opportunities for Eli Lilly in the obesity and type 2 diabetes treatment sectors, indicating potential for growth and increased market share [2].

Core Viewpoint - Roche is set to acquire 89bio for $3.5 billion to enhance its portfolio in cardiovascular, renal, and metabolic diseases [1][8] Acquisition Details - Roche will pay $14.50 per share in cash, totaling an equity value of approximately $2.4 billion [3] - 89bio shareholders will also receive a contingent value right (CVR) worth up to $6.00 per share, dependent on achieving specific commercial milestones [4] - If all CVR conditions are met, 89bio's shareholders could receive an additional cash consideration of up to approximately $1.0 billion [5] Pipeline Enhancement - The acquisition will add 89bio's pegozafermin, a phase III candidate for metabolic dysfunction-associated steatohepatitis (MASH), to Roche's pipeline [2][6] - Pegozafermin has a unique mechanism of action, potentially offering enhanced efficacy and tolerability, and may create synergies with Roche's existing CVRM portfolio [6] Market Context - MASH is a prevalent comorbidity of obesity, presenting a significant revenue opportunity for Roche as the obesity treatment market is lucrative [7] - Roche's shares have increased by 20.4% year-to-date, outperforming the industry growth of 2.5% [7] Strategic Moves - Roche has been actively seeking to enter the obesity treatment space, having previously collaborated with Zealand Pharma to co-develop petrelintide [9][10] - The recent acquisition trend in the pharma/biotech sector indicates a focus on portfolio expansion and pipeline innovation, with other companies like Novartis also engaging in significant acquisitions [10][11]