Viking Therapeutics(VKTX) - 2025 Q3 - Earnings Call Transcript

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]