Viking Therapeutics, Inc. Q2 FY2024 earnings call

• Positive clinical results in Q1 and Q2 2024: Phase 2 VENTURE trial for VK2735 showed weight loss, Phase 1 trial for oral VK2735 had encouraging results, Phase 2b VOYAGE trial for VK2809 showed histology improvements. - Phase 1b study for VK0214 in X-ALD completed enrollment. - Preclinical data on dual amylin and calcitonin receptor agonists presented at ADA. - Strong balance sheet with $942 million in cash as of June 30, 2024.

For the three months ended June 30, 2024, research and development expenses were $23.8 million compared to $13.9 million in the same period of 2023. General and administrative expenses were $10.3 million compared to $9.8 million in the same period of 2023. Net loss for the three months ended June 30, 2024, was $22.3 million, or $0.20 per share, compared to a net loss of $19.2 million, or $0.19 per share, in the corresponding period of 2023. For the six months ended June 30, 2024, research and development expenses were $47.9 million compared to $24.9 million in the same period of 2023. General and administrative expenses were $20.3 million compared to $19.4 million in the same period of 2023. Net loss for the six months ended June 30, 2024, was $49.6 million, or $0.46 per share, compared to a net loss of $38.8 million, or $0.44 per share, in the corresponding period of 2023. As of June 30, 2024, Viking held cash, cash equivalents, and short-term investments of $942 million.

• Plan to move VK2735 subcu into Phase 3 development after end-of-Phase 2 meeting. - Intend to initiate Phase 2 trial for oral VK2735 later in 2024. - Schedule end-of-Phase 2 meeting for VK2809 to discuss registration path. - Phase 3 registration program for subcu VK2735 is estimated to cost around $300 million. - Evaluate monthly dosing for VK2735 subcu.

Q: Further in response from the FDA, has the FDA made any commentary on Phase 3 design or what the Phase 2 conversations we've sent around? And just to make sure I heard correctly, is monthly dosing on the consideration for the Phase 3? And just one more. You know, based on what you've seen so far in terms of tolerability for the oral, are you considering additional cohorts beyond 100 milligrams?

A: Hi, Asim. Thanks for the questions. So the end-of-Phase 2 meeting, one of the primary goals of that dialogue, was to understand if we were okay to go forward into Phase 3. And we feel based on the feedback that we are okay to go forward. As far as trial design and things like that, that would be discussed more in a subsequent meeting and end-of-Phase 2 meeting. And as far as the details on what doses and frequencies, we're just not in a position to outline trial design at this point. With the oral dosing, we're at 100 milligrams right now. The dose-level review team generally meets upon completion of cohorts, and makes a recommendation whether or not to proceed. So hard to say if we would proceed. We haven't had completion of this cohort yet.

Q: Having completed the 60 and 80 milligram oral cohorts in the Phase 1 and moved to 100 milligrams, I guess the inference there is safety and tolerability were acceptable. But can you just elaborate on that inference, what you've seen through 80 milligrams, and if you're also seeing a dose response on weight loss through 80 milligrams?

A: Hi, Steve. Thanks. We're blinded to the data. So hard to comment on weight changes. Tolerability seems to be continuing to be very encouraging. I'll just say that.

Q: Can you clarify just the titration schema of those 60, 80 and 100 milligram cohorts? What's the starting dose and what are the titration steps there?

A: Yes. No good question. So we typically, what we've done is we've started each cohort with the highest dose from the prior cohort. So the 40 milligrams started at 20 for a week and then went to 40. The 60 started at 40 and then went to 60, and then the 80 started at 60 and then went to 80. That's the typical approach that we've used, as we escalate in doses.

Q: Can you please comment on how many Phase 3 studies you're thinking of running for subcu 2735? And also, how much each study might cost? And I guess since you were considering Phase 2b versus Phase 3, I guess what were some of the deciding factors in selecting to go ahead straight to Phase 3?

A: Thanks, Jay. Yes, for the clinical path in Phase 3, the guidance requires two studies, and a minimum of 4,500 people in those studies with at least 3,000 exposed to the drug. As far as the specifics of the trials we plan to conduct, I think it's early to disclose those details, but we would be looking to the guidance for the overall design strategy there. I may have forgot your... Oh, the cost yes Greg. You want to talk about the cost? Greg Zante: Yes, Jay. I think with respect to the cost, the Phase 3 registration program for subcu would be around $300 million in forming the guidance.

Q: If I could please sneak in one more question on the oral Phase 2 study, since that's expected to be 13 weeks of treatment, is it fair to assume that a pivotal study could be started following the completion of the oral Phase 2 study?

A: Good question. It's early to say we're kind of in the process of designing the Phase 2, but I think too early to call that.

Q: Hi, thanks for taking my question. And on the 60 to 80 milligram, you've made clear that the safety and tolerability were holding up, and it allowed you to move into the 100 milligram. What are the thresholds to stop dosing for the oral? I guess that's my first question. And the second is related to the Phase 3 program. Can you talk about some of the exploration that you feel that you need to do versus want to do with both the injectable, I guess as it released a titration dose finding and I guess the administration profile you mentioned, there's going to be potential for monthly. So does this all need to be conducted within the Phase 3 or are you doing any side exploratory Phase 2s in conjunction with that?

A: Yes, thanks Annabel. With the dose escalation studies with the oral formulation, normally the stopping in a Phase 1 study is driven by adverse events, or a plateau on exposures, or a plateau on some other metric that you - deem important. And so, the decision to continue escalating is driven by the dose level review team, and they've not indicated any reason to stop escalation. We do plan to start a Phase 2 study later this year so at some point there needs to be a decision to proceed on to the Phase 2. We're not at that stage right now, and it's hard to say when we would get to that stage, but we do plan to start the Phase 2 later this year. With respect to the overall Phase 3 strategy and doses and titration schedules, and the cadence of titration, also the cadence of overall dosing. It's just too early to discuss that right now. We're designing the Phase 3 program right now, but it's, we have to have the end-of-Phase 2 meeting and then outline the path forward from there.

Q: Can you please comment on how many Phase 3 studies you're thinking of running for subcu 2735? And also, how much each study might cost? And I guess since you were considering Phase 2b versus Phase 3, I guess what were some of the deciding factors in selecting to go ahead straight to Phase 3?

A: Thanks, Jay. Yes, for the clinical path in Phase 3, the guidance requires two studies, and a minimum of 4,500 people in those studies with at least 3,000 exposed to the drug. As far as the specifics of the trials we plan to conduct, I think it's early to disclose those details, but we would be looking to the guidance for the overall design strategy there. I may have forgot your... Oh, the cost yes Greg. You want to talk about the cost? Greg Zante: Yes, Jay. I think with respect to the cost, the Phase 3 registration program for subcu would be around $300 million in forming the guidance.

Q: Hi. Great. Thanks for that update and then picking up a question. Maybe just a follow-up on the partnership discussions. Understanding you have - open-door policy for the potential partner, but given this new development FDA allows you to proceed into Phase 2 directly, versus you need to do another Phase 2. Do you think that will change the conversation you have been having with the potential partners? Any comments will be helpful. And I have a follow-up?

A: Yes, sure. Thanks, Roger. Yes, no real additional comment to add on partner discussions. We've been consistent with our receptivity to interests and opportunities and we remain so. In the meantime, we are well capitalized and focused on execution of the development programs. And I think in our view, continued execution will continue to add value to the pipeline. I think that is all we can say at this point.

Q: Thanks for taking our questions. So Brian, I'm curious about your strategic positioning for the amylin program. I'm just curious what areas you would like to potentially position this asset. Would it be increasing the magnitude of weight loss and type 2 diabetes, or the preservation of lean body mass? So that's question number one. I'd also like to take your temperature on two topics, if you don't mind. One is on the titration. If you look across the landscape, it seems like other companies are exploring more rapid titration, with kind of a more aggressive step up. Is that something that is worthwhile exploring for the 2735 program? And the other topic is really on the monthly dosing that you just mentioned. Obviously, with the half-life at the end of the cycle, the drug level would be pretty low. Just curious if you can talk about that delta when you go from the end of the cycle to the next cycle, that increase and its relevance to the AE profile. And I have two just really quick checking questions?

A: Sure. I'll try to remember these, but you may have to repeat one or more. So with the amylin compound, really interesting mechanism that as a standalone, I think, has a lot of promise. And in combination, I think, also has a lot of promise. And we think both are worth exploring. So where they would actually position in the overall landscape, it's early to say, but to the extent maybe you could spare GLP-1 use, or not and see even further improvements in efficacy, we just don't know yet what that profile will look like. So, we'll have to follow where the data lead us. As far as the question on the different titration approaches, I think our tolerability profile and the PK profile would lend themselves to alternative titration cadences. But we did the three-week in the VENTURE study, which looked really promising. I think we could probably go to two weeks. Certainly, we could use four weeks, and maybe that would lead to an even further improvement in tolerability. So we're not yet at a position to say one way or another what's the, preferred titration scheme, but I think we could probably go faster. With respect to the monthly dosing, you're right. As you dose monthly, by the end of the month, now keep in mind that the half-life is 180 hours or so, so it's more than one week. But by the end of the month, you are at a lower level than you were at the beginning of the month. And as long as you're in a therapeutic range, that next dose might not be expected to result in any tolerability challenges. We won't know until we get into a study using it, but it seems like generally with these mechanisms, tolerability is observed early. And if you get through those first few weeks, tolerability tends to wane, at least with the injectables. And tolerability issues seem to wane. So if you're within the therapeutic plasma levels for 28 days or 30 days, and you're just raising those levels a little bit, it seems like you would reduce the risk of tolerability challenges. But again, hard to say at this point.

Q: Hi, this is Rohit on for Mike. Thanks for taking our questions. Just in terms of dose escalating for oral VK2735, is there a point where tablet size and available supply become an issue and how high you can dose the drug?

A: Yes, no, it's a good question. Probably, we're not there just yet. But yes, I think those are considerations that need to be taken into account, when you dose up with oral. I think, moving forward, if the oral was used as a maintenance therapy after target weight was achieved, that likely reduces dramatically the actual requirements of API. And if the dosing were able to be less frequent, that also would dramatically reduce the API demand. So a lot of moving parts there in trying to project the API demands moving forward.

Q: Hi, Brian. Thanks for taking the question and congrats on the progress here. Maybe just the decision to move to a monthly dosing regimen, including that in the move forward program, is that based off of the PK/PD data that you've seen thus far? And do you think you'll be able to present that data perhaps at Obesity Week?

A: Yes, no, thanks, Justin. Yes, it is based on the PK profile. The PK profile does suggest that monthly is feasible. We won't know until we actually do a study, but at least what it looks like today, is it's feasible.

Q: Hi, guys. Good afternoon. Thanks for taking the questions and congrats on the progress. So you're going to have multiple Phase 3 programs ready to start here in the - pretty much in the near term. I know you've previously talked about having a partner, potentially for NASH. Could you just provide an update on how you're thinking about business development and partnerships across obesity and NASH, and I guess your appetite to execute across these programs on your own?

A: Yes, thanks, Tom. I mean, we're capitalized to proceed with all of these programs. Fortunately with the obesity program, we will be moving aggressively into a Phase 3 development program as soon as possible. With the NASH program, the plan there is to have an end-to-Phase 2 meeting and receive the feedback and understand what the current thinking is, around registration paths. And what we've been saying, or what we've been preferring with that program really, is to work with a larger party together on a registration path. So that remains the preference for the NASH program.

Q: Good afternoon. Thanks for taking the questions and congrats on all the progress. I got two questions here. The first one is in terms of the oral 2735 for the Obesity Week readouts. Do we anticipate that will also include the 100 milligrams as well? And so would that be the also use that as a basis for your 13-week study? Then I have a follow-up?

A: Yes, thanks, Yale. We will present all of the data that we have at the time, and I would expect the 100 milligrams cohort to be included. And as far as the Phase 2 doses, we haven't decided yet. So, we need to complete the ongoing cohorts and understand, get unblinded on the data and understand what the profile looks like before we select those doses.

Q: Hi, guys. Good afternoon. Thanks for taking the questions and congrats on the progress. So you're going to have multiple Phase 3 programs ready to start here in the - pretty much in the near term. I know you've previously talked about having a partner, potentially for NASH. Could you just provide an update on how you're thinking about business development and partnerships across obesity and NASH, and I guess your appetite to execute across these programs on your own?

A: Yes, thanks, Tom. I mean, we're capitalized to proceed with all of these programs. Fortunately with the obesity program, we will be moving aggressively into a Phase 3 development program as soon as possible. With the NASH program, the plan there is to have an end-to-Phase 2 meeting and receive the feedback and understand what the current thinking is, around registration paths. And what we've been saying, or what we've been preferring with that program really, is to work with a larger party together on a registration path. So that remains the preference for the NASH program.