Viking Therapeutics (NasdaqCM:VKTX) FY Conference Transcript

Viking Therapeutics FY Conference Summary Company Overview - Company: Viking Therapeutics (NasdaqCM: VKTX) - Industry: Biopharmaceuticals focusing on cardiometabolic diseases, particularly obesity and metabolic disorders [6][41] Key Points and Arguments Clinical Programs - Viking is developing novel therapeutics for metabolic and endocrine diseases, with a focus on obesity [6] - The lead program is VK2735, a dual agonist of GLP-1 and GIP receptors, currently in the VANQUISH Phase III program for obesity [7][41] - An oral formulation of VK2735 has completed a successful Phase II study, achieving primary and secondary endpoints [7][41] - An amylin agonist is planned to enter clinical trials by late 2025 or early 2026 [7][41] - Other compounds include VK2809 for NASH and VK0214 for X-linked adrenoleukodystrophy, which are available for licensing [8] Clinical Data Highlights - VK2735 has shown robust weight loss results, with up to 30% weight loss observed in animal studies [10] - The oral formulation demonstrated an 8.2% reduction in body weight after 28 days in Phase I trials, with a durable effect maintained at 8.3% after 57 days [13][14][15] - The Phase II oral study showed a 12% weight loss at the highest dose after 13 weeks, with a favorable tolerability profile [28] - The subcutaneous formulation achieved nearly 15% weight loss after 13 weeks, with over 90% of adverse events being mild to moderate [37] Future Plans - Viking plans to initiate a subcutaneous to oral maintenance study by late 2025 or early 2026 [29][43] - An end-of-Phase II meeting with the FDA is anticipated in Q4 2025 to discuss the path forward for the oral formulation [43][44] - The company aims to explore the combination of amylin with dual agonists to enhance weight loss efficacy [66] Market Position and Strategy - Viking operates with a lean structure, having over $800 million in cash to support ongoing trials [40][56] - The obesity market is evolving, with a significant shift towards direct-to-patient models, which Viking is well-positioned to leverage [56][70] - The company emphasizes the importance of efficacy and tolerability in its products to compete effectively in the market [64] Regulatory and Ethical Considerations - Current regulatory pathways require weight loss evidence for approval, with no specific path for maintenance therapies [46] - The company faces challenges in maintaining patient retention in placebo-controlled trials, which is critical for trial success [51][52] Additional Important Insights - The company has a strong focus on optimizing titration rates to minimize adverse events, particularly gastrointestinal issues [58][59] - Viking's strategy includes potential collaborations with larger companies for effective program development while maintaining the ability to operate independently [68] - The future vision includes having multiple products on the market and expanding internationally, utilizing a direct-to-patient model [70][71]