Viking Therapeutics (NasdaqCM:VKTX) FY Conference Transcript

Viking Therapeutics FY Conference Summary Company Overview - Company: Viking Therapeutics (NasdaqCM: VKTX) - Industry: Biotechnology, specifically focusing on obesity treatments Key Points and Arguments Ongoing Trials and Programs - Viking Therapeutics is conducting two Phase III trials in obesity, initiated in Q2 2025, with good enrollment progress expected to continue for 78 weeks post-enrollment completion [2][3] - A Phase IIa trial showed a 12.2% weight loss over 13 weeks with an oral formulation, indicating good tolerability [2][5] - Plans to schedule an end-of-Phase II meeting with the FDA by year-end for the oral program [3] - An earlier program targeting the amylin receptor for obesity is expected to file an IND by year-end, followed by a Phase I study in 2026 [3] Weight Loss Efficacy - The oral program demonstrated a dose-response relationship, with weight loss ranging from 2.3% to 12.2% across doses of 30 to 120 mg [8] - A unique transition dosing arm showed continued weight loss even after reducing the dose from 90 mg to 30 mg, which was unexpected [9][15] Safety and Tolerability - The Phase II study reported higher gastrointestinal (GI) adverse events than Phase I, particularly nausea, but the overall adverse event profile was considered manageable [11][12] - The company plans to adjust the titration schedule to mitigate adverse events in future studies [12] Maintenance Strategies - The importance of maintenance dosing strategies for obesity therapies was emphasized, with ongoing studies to evaluate various maintenance regimens [4][19] - The potential for transitioning patients from high doses to lower maintenance doses could improve cost-effectiveness and treatment persistence [15][41] Manufacturing and Supply Chain - Viking Therapeutics signed an agreement with Corden Pharma to ensure a reliable supply chain for their products, addressing concerns about product shortages in the obesity market [32][33] - The agreement includes a multi-ton annual supply of active pharmaceutical ingredients (API) and significant production capacity for various formulations [34][36] Financial Position - The company reported over $800 million in cash, with a burn rate of approximately $50 million per quarter, which is expected to cover ongoing Phase III studies [50] Competitive Landscape - Viking Therapeutics acknowledges the competitive nature of the obesity market but believes their flexible treatment options will enhance patient adherence and long-term health benefits [41][42] - The company is open to partnerships for commercialization but is also preparing to operate independently [41] Future Programs - The amylin receptor agonist program is seen as a potential standalone treatment for patients with lower BMI who may not tolerate GLP-1 agonists [44][45] - Viking's NASH and X-ALD programs are also in development, with plans to seek partners for Phase III trials in NASH due to the complexity of the studies [47][48] Regulatory Environment - The company has not experienced significant disruptions in its interactions with the FDA despite broader concerns about regulatory stability [54] Additional Important Insights - The company is exploring the use of artificial intelligence in drug discovery, although its current focus remains on executing known development plans [53] - Viking Therapeutics is aware of the increasing competition from biotech innovations in China but remains focused on its strategic goals [52]