Viking Therapeutics, Inc. Q3 FY2025 earnings call

• Clinical progress: The early part of the third quarter was focused on ramping up the Phase III VANQUISH Obesity program for VK2735. The Phase II VENTURE-Oral Dosing Trial of oral VK2735 showed positive top-line results with statistically significant weight loss reductions and favorable safety. The company initiated a Phase I study to evaluate maintenance dosing with VK2735.
• Program advancement: Progressed the amylin receptor program toward an IND filing expected in the first quarter of 2026.
• Financial position: Sufficient cash reserves ($715 million) to complete planned Phase III obesity trials and advance other programs.

For the third quarter ended September 30, 2025, research and development expenses were $90 million compared to $22.8 million in the same period of 2024. General and administrative expenses were $8.6 million compared to $13.8 million in 2024. Net loss was $90.8 million or $0.81 per share compared to $24.9 million or $0.22 per share in 2024. For the first 9 months ended September 30, 2025, research and development expenses were $191.5 million compared to $70.7 million in 2024. General and administrative expenses were $37.1 million compared to $34 million in 2024. Net loss was $202 million or $1.80 per share compared to $74.5 million or $0.69 per share in 2024. Cash, cash equivalents, and short-term investments were $715 million as of September 30, 2025, compared to $903 million as of December 31, 2024. No distinct product segments with revenue contribution percentages are noted.

• Enrollment in the VANQUISH Phase III studies is proceeding well, with expected completion of VANQUISH-1 by the end of 2025 and VANQUISH-2 by the first quarter of 2026.
• Plan to submit an end of Phase II meeting request to the FDA for the oral formulation of VK2735 later in the fourth quarter of 2025.
• Expect to report results of the Phase I maintenance study in the mid-2026 time frame.

• Potential clinical trial outcomes not meeting expectations.
• Regulatory hurdles in obtaining approvals.
• Possible impacts of external factors (e.g., government shutdowns) on trial timelines.

Q: Just obviously, enrollment is going very well in Phase III. I wanted to ask if you had any sense of early signs of patient persistence, discontinuation rate? And if you're happy with what you see there on trial execution side? And then on the maintenance study, hoping you could expand on just the 19-week induction versus 12-week maintenance. What are you doing during that induction phase? How fast are you titrating patients up? What dose is being contemplated there?

A: Yes. Thanks, Steve. Yes, the VANQUISH studies have enrolled maybe a little ahead of schedule. I think that reflects a fair amount of enthusiasm for the program, and we're happy to see that nothing notable at this point. We're still pretty early in the treatment windows. There's nothing that's suggestive of any persistence issues or anything like that. It's so far going very well according to plan. With the maintenance study, we're titrating people up. We can't start the maintenance portion on that -- the level of dose that we're targeting. So you got to titrate up to that dose before transitioning to the monthly cadence. And so we'll titrate people up to 17.5 mg. Some will go up to 22.5, some to 20, and then we'll have another cohort go up to 15 milligrams. So those titration windows are what takes us to get up to 19 weeks. And it's a little bit of an acceleration in the titration window versus the 4-week blocks in the Phase III study.

Q: Just following up on the prior question on the maintenance study, are you able to share what the month -- the doses for the monthly subcu daily oral and the weekly oral that are being tested? And I have a quick follow-up after that.

A: Yes. The monthly doses will continue from their last weekly dose. So that's -- the range would be 15, 17.5, 20 and 22.5 on a monthly cadence. And the dailies then will be 17.5, a second one at 27.5, and then the weekly is 110 milligrams per week.

Q: My question is, if the maintenance study shows compelling evidence supporting one or more regimen. What's the next clinical step for validating a maintenance regimen and potentially getting it on a future label? And is it a realistic option at all to add an expansion arm to the banker study?

A: I think that latter question is probably a little more challenging. Those studies are well on their way and adding a monthly regimen to the extension, probably -- it just probably complicates things. I think the next step there would be depending on what the data show a longer study, whether that's a Phase IIb or a Phase III to go right to label language. We don't know yet. We'll have to see what these data show us.

Q: Brian, congrats on all the progress across so many different fronts, including your pioneering maintenance study. Maybe just to shift gears for a moment to bigger picture question. what sort of lessons learned or read across have you gotten from recent dynamics in the oral GLP-1 space? It seems like yesterday's update on TERN-601 kind of shows the high rate of attrition there and especially potential for safety and tolerability concerns with small molecule oral GLP-1s, what do you think is the read across or learnings that are important for your program? And then I had a follow-up, if I could.

A: Yes. Well, I think one thing that we think stands apart with our program is that -- the safety profile looks very strong. The tolerability profile looks very strong as well. We learned a lot from our own the Phase II VENTURE-Oral dosing study about probably best to start at a lower dose than we started there and extend the titration windows. But what we saw from that study based on the trajectories was really, really encouraging as we look at a longer-term dosing window. I think what you see in the oral studies generally is -- I mean, it's really difficult small molecule peptide or anything. It's really, really difficult to develop these therapeutics. So the attrition is, I guess, just a reflection of those challenges. But I think we feel really good about where we are in the competitive landscape with the oral peptide.