Viking Therapeutics, Inc. Q1 FY2024 earnings call

• Viking announced positive results from 2 key pipeline programs: Phase II VENTURE study for VK2735 in obesity achieved primary and secondary endpoints, and Phase I trial for oral VK2735 showed promising safety, tolerability, and weight loss.
• Plans to advance both VK2735 programs into further development later in 2024.
• Completed final biopsies in Phase IIb VOYAGE study for VK2809 in NASH and fibrosis, expecting to report results later in Q2 2024.
• Completed public offering of common stock, raising ~$630 million, strengthening the balance sheet.
• Details on VK2735: VENTURE study showed statistically significant weight loss, oral VK2735 study showed safety, tolerability, and dose-dependent weight loss.
• Update on VK2809: VOYAGE study had initial positive results on liver fat reduction, and VK0214's Phase Ib trial in X-ALD is ongoing with expected mid-2024 results.

Research and development expenses for the three months ended March 31, 2024 were $24.1 million, compared to $11 million in the same period of 2023. General and administrative expenses were $10 million in Q1 2024 vs. $9.5 million in Q1 2023. Net loss was $27.4 million in Q1 2024 compared to $19.5 million in Q1 2023. As of March 31, 2024, Viking held cash, cash equivalents, and short-term investments of $963 million, up from $362 million as of December 31, 2023, due to the $630 million gross proceeds from the public offering closed on March 4, 2024.

• Intends to advance VK2735 programs into further development later in 2024.
• Expect to report VOYAGE study data later in Q2 2024.
• Anticipates announcing Phase Ib VK0214 data in mid-2024.

• Forward-looking statements subject to risks and uncertainties that could materially affect actual results.
• Supply chain challenges in manufacturing, as seen with other drugs in the space.
• Ongoing litigation with Gannex related to intellectual property disputes.

Q: Congrats on the quarter. Sarcopenia is getting a lot of attention... Any thoughts on bringing back 5211 as an add-on strategy?

A: Joon, yes, thanks for the question. Yes, it is, I think, getting to be more popular in the conversation, what we have kind of always said and hasn't really changed. It's hard to understand the clinical significance of the loss in muscle and whether that actually has an impact on function or feeling or survival, which are what -- or typically used for approval. But -- it's a good point that 5211 compound is the most potent SARM that we're aware of. And to the extent muscle losses considered to be clinically relevant more so in the pharmacologic setting versus the regular diet exercise setting, it could be something that's really useful.

Q: Maybe on VK2809, what's the general translatability of kind of the 12-week MRI-PDFF result into later histology endpoints... And then maybe as a third and final question, how do you think the thyroid beta agonist market will develop?

A: Yes. Thanks, Kambiz. So with the translatability for liver fat to histologic improvement, generally, it has been shown that reducing liver fat, particularly above that 30% relative reduction threshold has led to improved odds of histologic benefit. There are some exceptions to that. But generally, there are more examples of that proving out than not. And I think it's more of a compound by compound situation when you try to translate to precise liver fat reduction to histologic improvement. I think the best comparator for us would be the other thyroid agonist that was recently approved. It showed in the -- somewhere in the teens range for NASH resolution and it did show some improvement in fibrosis. So to the extent we have a similar or better liver fat reduction, I think that would be sort of the range we would be looking at for NASH resolution and fibrosis improvement. With respect to the overall market, yes, it does seem like there is a rapid expansion of the GLP-1 utilization. And so that probably does create some headwind on the uptick of new NASH drugs, but we've not had an approved drug for NASH. So now that we do, I think it's going to be really important to see how the first few quarters mature there. And maybe there is a backlog of people waiting to try it and a backlog of clinicians waiting to prescribe it. So unknown right now, it's hard to project. But it is true that the GLP-1s are getting more and more utilization.