VK2735 Phase III Plans
Q: What are the plans for moving VK2735 subcutaneous into Phase III?
A: We are preparing to advance VK2735 into Phase III development for obesity. We've scheduled an end-of-Phase II meeting with the FDA later this quarter to review the proposed protocol, doses, and trial size. We aim to initiate the Phase III trial as soon as possible after that. * *

FDA Feedback on VK2809
Q: Any surprises from the FDA feedback on VK2809, and how does it impact partnering plans?
A: We recently received written responses from the FDA regarding VK2809 for NASH and fibrosis. There were no real surprises or unexpected comments. We are reviewing them and evaluating next steps. We've always felt that the NASH program would be best handled with a larger pharma collaborator, and that continues to be our approach. * *

VK2735 Oral Dose Escalation
Q: Have you completed dose escalation for oral VK2735 up to 100 mg, and any comments on higher doses?
A: Yes, we dosed up to 100 mg in the Phase I trial for oral VK2735. There was nothing in the data to preclude dosing higher. We are considering exploring higher doses in the Phase II study, and we'll disclose more at the upcoming ObesityWeek conference. * *

Manufacturing Capacity and Supply
Q: How are you preparing for manufacturing capacity to support clinical and potential commercial needs?
A: We currently have sufficient drug supplies for our planned development activities for both subcutaneous and oral formulations. We are engaging with key global peptide suppliers and working towards long-term supply agreements. We are confident in our ability to supply a blockbuster-size product at the appropriate time. * *

Amylin Agonist Program
Q: How are you thinking about the amylin agonist program and potential combination with VK2735?
A: We see significant value in combining our amylin agonist with VK2735. Amylin acts via a different mechanism than GLP-1 and GIP, potentially providing an additive effect on weight loss. We're aiming to bring a compound into the clinic in 2025, starting with a single agent and rapidly following with combination studies. * *

Use of Auto-Injector in Phase III
Q: Will you use an auto-injector in the Phase III trial for subcutaneous VK2735?
A: Yes, we plan to use an auto-injector in the Phase III study. If available soon enough, we'll use it from the onset; otherwise, we'll transition participants from a vial and syringe to the auto-injector during the study. * *

Monthly Dosing for Maintenance
Q: Is monthly dosing of VK2735 feasible, and will it be incorporated into Phase III?
A: Our pharmacokinetic data support the feasibility of monthly dosing of VK2735. We view monthly dosing primarily as a maintenance regimen for patients who have reached their target weight. We plan to test monthly dosing in a stand-alone study rather than including it in the initial Phase III. * *

Value Split Between VK2735 Forms
Q: How do you see the value split between subcutaneous and oral forms of VK2735?
A: We consider the subcutaneous formulation as the anchor of the franchise, representing about 80% of the opportunity, with the oral form adding the remaining 20%. While oral options are attractive, the injectable market is rapidly expanding and is expected to exceed $40 billion without an oral form. * *

Expanding Infrastructure
Q: How are you expanding your infrastructure to support upcoming trials?
A: We have been aggressively adding staff across various functions, including regulatory affairs, clinical development, manufacturing, and more. We believe this positions us well for the more complex Phase III trials ahead. * *

Manufacturing Route Discussions
Q: Any updates on choosing a synthetic manufacturing route with external suppliers?
A: We continue to have discussions with global peptide suppliers regarding various synthetic routes for scaling up production. This is in progress, and we'll provide more details once decisions are made. * *