Q2 2024 Earnings Summary
- VKTX is advancing VK2735 into Phase III development for obesity, moving aggressively with sufficient capital and drug supply to fully complete planned clinical trials for both subcutaneous and oral formulations. The subcutaneous formulation has demonstrated up to approximately 15% reduction in body weight after 13 weeks.
- The oral formulation of VK2735 is showing promising safety and tolerability at higher doses, with ongoing dose escalation up to 100 mg and plans to present data at Obesity Week. A Phase II study is planned to start later this year.
- VKTX is expanding its obesity pipeline with a dual amylin and calcitonin receptor agonist (DACRA) program, showing promising preclinical data and expected to enter clinical development in 2025, indicating strong commitment to innovation and pipeline growth.
- The company anticipates spending around $300 million on the Phase III registration program for its subcutaneous obesity treatment VK2735, excluding additional costs for cardiovascular outcomes trials, which may require significant additional funding.
- Uncertainty regarding partnerships for the NASH program persists, as the company prefers to work with a larger partner but has not provided meaningful updates on partnering discussions, potentially indicating difficulties in securing a partnership that could delay progression into Phase III trials.
- The company's resources may be stretched thin due to multiple ongoing programs, including the development of both subcutaneous and oral formulations of VK2735, the NASH program, and new preclinical initiatives, which could impact development timelines and focus.
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Phase III Advancement
Q: Will you move directly into Phase III for VK2735?
A: Yes, based on FDA feedback, we plan to advance VK2735 into Phase III development for obesity without a Phase IIb trial. We intend to schedule an end-of-Phase II meeting in the fourth quarter to discuss the development plan. -
Funding and Costs
Q: Do you have enough cash and supply for Phase III?
A: Yes, we have sufficient cash and drug supply to complete our planned clinical trials, including Phase III for obesity, with costs estimated around $300 million. -
Partnership Plans
Q: Are you seeking partners for obesity and NASH programs?
A: While we're open to partnerships, we are capitalized to proceed independently with our programs, aggressively advancing into Phase III for obesity and preferring to partner for NASH. -
Drug Supply & Scalability
Q: Can you meet supply needs for trials and commercialization?
A: We currently have enough active pharmaceutical ingredient (API) to get through all planned clinical studies for both subcutaneous and oral formulations, and we expect to supply initial commercial demand using contract manufacturing organizations. -
Oral VK2735 Dosing
Q: How is tolerability at higher oral VK2735 doses?
A: Tolerability remains encouraging up to 80 mg daily, allowing us to escalate to a 100 mg cohort. We are blinded to weight changes, but no safety signals have prompted us to stop dosing. -
Oral Program Updates
Q: Will 100 mg data be presented at Obesity Week?
A: We plan to present all available data, including the 100 mg cohort, at Obesity Week and initiate a 13-week Phase II study in the fourth quarter, though doses are yet to be decided. -
Amylin Program Strategy
Q: How will you position the amylin program?
A: The amylin receptor agonist shows promise both as a single agent and in combination, potentially enhancing weight loss efficacy and possibly representing best-in-industry profiles when combined with GLP-1/GIP agonists. -
Dosing Strategies
Q: Will you explore faster titration or monthly dosing?
A: Yes, our pharmacokinetic profile supports exploring faster titration schedules and monthly dosing regimens, which could enhance patient convenience without compromising tolerability.
Research analysts covering Viking Therapeutics.