Release Date: July 24, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Viking Therapeutics Inc (VKTX, Financial) announced positive results from the Phase II VENTURE trial evaluating VK2735 for obesity treatment, showing significant weight reductions.
- The company reported encouraging results from a Phase I trial of an oral formulation of VK2735, demonstrating weight loss and excellent tolerability.
- Positive 52-week histology results from the Phase IIb VOYAGE trial for VK2809 in NASH and fibrosis treatment were achieved, meeting secondary and exploratory endpoints.
- Viking Therapeutics Inc (VKTX) presented promising preclinical data on dual agonists of the amylin and calcitonin receptors, showing potential for obesity treatment.
- The company ended the second quarter with a strong balance sheet, holding over $900 million in cash, providing resources to advance pipeline programs.
Negative Points
- Research and development expenses increased significantly to $23.8 million for Q2 2024, up from $13.9 million in Q2 2023, primarily due to higher manufacturing and clinical study costs.
- General and administrative expenses rose to $10.3 million for Q2 2024, compared to $9.8 million in Q2 2023, driven by increased stock-based compensation and third-party consultant services.
- Viking Therapeutics Inc (VKTX) reported a net loss of $22.3 million for Q2 2024, higher than the $19.2 million net loss in Q2 2023.
- The company faces uncertainties regarding the scalability and commercial demand for its oral peptide formulations, which could impact future supply and production costs.
- Despite positive trial results, the company still needs to conduct further studies and regulatory meetings, which could delay the commercialization of its drug candidates.
Q & A Highlights
Q: Congrats on the quarter and thanks for taking the questions. So further in response from FDA has SD. need any commentary on Phase three design or what the Phase two conversations center around and just to make sure I heard correctly is monthly dosing under consideration for the Phase three and just one more on based on what you've seen so far in terms of tolerability for the oral, are you considering additional cohorts beyond 100 milligrams?
A: So the end-of-Phase two meeting that one of the primary goals of that dialogue was to understand if we were okay to go forward into Phase three and we feel based on the feedback that we are okay to go forward as far as trial design and things like that data that would be discussed more in a subsequent meeting an end of Phase two meeting. And as far as the details on what you know, doses and frequencies. We're just not in a position to outline trial design at this point with the oral dosing arm, we are 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 the completion of this cohort yet.
Q: Having completed the 60 and 80 milligram oral cohorts in the Phase one and move to 100 milligrams. I guess the inference there is safety and tolerability were acceptable, but can you just elaborate on that in France, what you've seen through 80 milligrams.
A: And if you're also seeing a dose response on weight loss through 80 milligrams as she thinks we're blinded, I've got a little background there, we're blinded to the to the data to come. So part to comment on that on weight changes, tolerability seems to be continuing to be very encouraging.
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: The way we typically of what we've done is we have started each cohort with the highest dose from the prior cohort. So the 40 milligram 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 that the typical approach that we've used as we escalate and doses course.
Q: Do you have enough drug on hand and enough cash to complete the fully complete from the Phase three program that you intend to propose to FDA for an obesity indication?
A: Yes, we do have enough supply on hand to meet really all of our planned clinical trials with both the subcu and the oral. So what we want to we won't be needing further material over. We're always making material, but we won't be needing any further material to complete the planned studies.
Q: Can you please comment on on how many Phase three studies you're thinking of running for subcu two, seven, three, five and also how much each study might cost? And I guess since you were considering Phase IIb versus Phase three, I guess what were some of the deciding factors in selecting to go ahead straight to Phase three.
A: Yes, for the or the clinical path in Phase three, the guidance requires two studies and a minimum of 45 hundreds of people in those studies with the at least 3,000 exposed to the drug. And 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. And there I may have forgot your so the cost, the grading on time as well? Yes, Jay, I think with respect to the cost of the Phase three registration program for subcu would be around 300 million confirming the guidance.
Q: Is it fair to assume that a pivotal study could be started following the completion of the oral Phase two study?
A: Yes, good, good question. It's early to say, and we're kind of in the process of designing the Phase two. But I just I think too early to call that.
Q: Can you talk about some of the exploration you feel that you need to do versus want to do with both the or with the injectable. I guess as it relates to titration dose finding and I guess the the administration profile you mentioned there's going to be potential for monthly and so does this all need to be conducted within the Phase three? Are you doing any side exploratory Phase twos in conjunction with that?
A: We'd see a dose escalation studies with the with the oral formulation is normally the that stopping in a Phase one study is driven by it adverse events or a plateau on exposures or a plateau on on some other metric that you're you deem important. And so the decision to continue escalating is driven by the at that dose level review team, and they've not done indicated any reason to stop escalation. We do plan to start a Phase two study later this year. So at some point there needs to be a decision. Two, two, we proceed on to the Phase two. 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 two and later this year with respect to the overall Phase three strategy and doses and titration schedules and the cadence of it titration also the cadence of overall dosing, which it's just too early to discuss that right now, we're designing the Phase three program right now, but it's a we have to have the end of Phase two meeting and then outline the path forward from there.
Q: Do you think that will change the conversation you have been having with potential partners on any comments will be helpful and I have a follow-up.
A: There's no real additional comment to add on partner discussions, and we've been consistent with our receptivity to interests and opportunities, and we remain so in the meantime, we're 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's all we can say at this point?
Q: Can you just remind us then what what's the scale of the investment into R&D USD and the time to be able to build that capacity to potentially need commercial demand as an oral peptide. Also considering your and as dosing is going even higher than on which the goods Carnaby?
A: We currently have enough API to to get through all of our planned clinical studies with both the subcu and the oral. And we continue to engage with suppliers for both the raw materials and the finished goods product. And we certainly expect to be able to supply the initial commercial demand at the appropriate
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
