Viking Therapeutics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 5, 2025

There are 15 speakers on the call.

Operator

Welcome to the Viking Therapeutics Fourth Quarter and Full Year twenty twenty four Financial Results Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question, you may press the star key followed by the number one on your touch tone phone. If anyone has difficulty hearing the conference, please press star and then 0 for operator assistance.

Operator

As a reminder, this conference call is being recorded today, 02/05/2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Speaker 1

Hello, and thank you all for participating in today's call. Joining me today is Brian Lien, Viking's President and CEO and Greg Zanti, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, 02/05/2025, will contain forward looking statements under the Safe Harbor provisions of The U. S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones.

Speaker 1

Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

Speaker 2

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the three months and full year ended 12/31/2024, and provide an update on recent progress with our development programs and operations. 2024 was an exceptionally busy year for Viking. During the year, the company reported successful results from four different studies across our pipeline. These include the announcement of positive data from our VK2735 subcutaneous program for obesity, the results of our VK2735 oral tablet program for obesity, the histology results from our VK2809 program for the treatment of MASH and fibrosis and the initial proof of concept data from our VK0214 program for X ALD.

Speaker 2

With respect to VK2735, our lead program for obesity, in in the first quarter of twenty twenty four, we announced positive results from the Phase II VENTURE trial evaluating subcutaneous administration in obese subjects. This trial demonstrated impressive reductions in body weight after thirteen weeks of treatment. Later in the first quarter, we announced the initial results from a twenty eight day Phase one trial evaluating an oral tablet formulation of VK2735, which demonstrated excellent tolerability and encouraging reductions in body weight. In the second quarter of twenty twenty four, we announced histology results from the Phase 2b VOIAGE trial evaluating our novel thyroid hormone receptor beta agonist VK2809 for the treatment of MASH and fibrosis. This study successfully achieved its primary, secondary and exploratory endpoints showing reductions in liver fat at 12 and improvements in MASH resolution rate and fibrosis after fifty two weeks.

Speaker 2

And finally, in the fourth quarter of twenty twenty four, the company announced positive results from a twenty eight day Phase 1b clinical trial of our second novel thyroid hormone receptor beta agonist VK0214 in patients with X linked adrenoleukodystrophy or XALD. Results from this study showed VK0214 to be safe and well tolerated and treated patients demonstrated significant reductions in plasma levels of very long chain fatty acids compared with placebo. During the year, the company also announced the addition of a new program to its pipeline focused on a series of internally developed agonists of the amylin receptor. In animal models, these compounds demonstrated improvements in body weight and metabolic profile. On the corporate side, during the first quarter of twenty twenty four, Viking closed a successful public offering of common stock raising more than $630,000,000 in gross proceeds providing the resources to aggressively move forward with our pipeline programs.

Speaker 2

I'll have additional comments on our operations and development activities after we review our financial results for the fourth quarter and year ending December 31. For that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer.

Speaker 3

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the fourth quarter and full year ended 12/31/2024, beginning with the quarter. Research and development expenses were $31,000,000 for the three months ended 12/31/2024, compared to $20,500,000 for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, salaries and benefits and stock based compensation, partially offset by decreased expenses related to clinical and preclinical studies.

Speaker 3

General and administrative expenses were $15,300,000 for the three months ended 12/31/2024, compared to $8,800,000 for the same period in 2023. The increase was primarily due to increased expenses related to legal and patent services, stock based compensation, salaries and benefits, insurance and professional fees. For the three months ended 12/31/2024, Viking reported a net loss of $35,400,000 or $0.32 per share compared to a net loss of $24,600,000 or $0.25 per share in the corresponding period of 2023. The increase in net loss for the three months ended 12/31/2024 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023. I'll now go over our results for the full year ended 12/31/2024.

Speaker 3

Our research and development expenses for the year ended 12/31/2024 were $101,600,000 compared to $63,800,000 for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, stock based compensation and salaries and benefits, partially offset by a decrease in expenses related to clinical and preclinical studies. Our general and administrative expenses for the year ended 12/31/2024 were $49,300,000 compared to $37,000,000 for the same period in 2023. The increase was primarily due to increased expenses related to stock based compensation, salaries and benefits, professional fees, insurance and services provided by third party consultants, partially offset by decreased expenses related to legal and patent services. For the year ended 12/31/2024, Viking reported a net loss of $110,000,000 or $1.01 per share compared to a net loss of $85,900,000 or $0.91 per share in the corresponding period in 2023.

Speaker 3

The increase in net loss for the year ended 12/31/2024 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023. Turning to the balance sheet at 12/31/2024 Viking held cash, cash equivalents and short term investments of $9.00 $3,000,000 compared to $362,000,000 as of 12/31/2023. This concludes my financial review and I'll now turn the call back over to Brian.

Speaker 2

Thanks, Greg. I'll now provide a summary of clinical highlights from 2024 and outline next steps with our pipeline programs starting with our lead obesity program VK2735. VK2735 is a dual agonist of glucagon like peptide one or GLP-one receptor and the glucose dependent insulinotropic polypeptide or GIP receptor. The company's initial Phase one single and multiple ascending dose trial for VK2735 demonstrated the promising safety, tolerability and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection for up to four weeks. Subjects in the study demonstrated up to approximately 8% weight loss from baseline after twenty eight days with no signs of plateau.

Speaker 2

Following these results, the company initiated a Phase two study called the VENTURE study to evaluate longer term dosing with VK2735 in subjects with obesity. This trial was a randomized, double blind, placebo controlled, multicenter study that evaluated the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 administered subcutaneously once weekly for thirteen weeks. In the first quarter of twenty twenty four, the company announced positive results from the VENTURE trial, which successfully achieved its primary and secondary endpoints. The study demonstrated that patients receiving VK2735 achieved statistically significant reductions in mean body weight from baseline ranging up to 14.7%. The Venture study also showed VK2735 to be safe and well tolerated through thirteen weeks of dosing with the majority of treatment emergent adverse events characterized as mild or moderate.

Speaker 2

Adverse events generally occurred early in the course of treatment and were primarily related to the expected GI effects resulting from activation of the GLP-one receptor. These data were presented last November at Obesity Week, the annual meeting of the Obesity Society. This presentation also provided updated results from follow-up visits that occurred four and seven weeks after the last dose of VK2735 was administered. These results showed that cohorts receiving VK2735 maintained the majority of their weight loss through the seven week follow-up visit after administration of the final dose of DK2735. This included the two point five milligram weekly dose, the lowest dose evaluated for which over 90% of the initial weight loss was maintained seven weeks after the last dose was administered.

Speaker 2

In a subset of participants, an evaluation of plasma levels of VK two thousand seven hundred and thirty five at various time points following the thirteen week dosing period was also conducted. We believe these pharmacokinetic results provide support for the feasibility of once monthly dosing in the maintenance setting and we plan to further evaluate monthly dosing later this year. Following completion of the venture study, Viking requested and was granted a Type C meeting with the FDA to discuss next steps for the program. Based on written feedback from this meeting, we advanced VK two thousand seven hundred and thirty five into Phase three development for obesity. To this end, in the fourth quarter of twenty twenty four, we completed a successful end of Phase two meeting with the agency, which was extremely helpful in informing our next steps and the Phase three plan for the program.

Speaker 2

We currently expect to initiate Phase three trials evaluating subcutaneous VK2735 for the treatment of obesity in the second quarter of twenty twenty five. Also in 2024, we completed a Phase one study to evaluate an oral tablet formulation of VK2735. The company believes a tablet formulation could represent an attractive treatment option for those who may be hesitant to initiate injection based therapy or for those seeking to maintain the weight loss they have already achieved. An important differentiating advantage of a tablet formulation of VK two thousand seven hundred and thirty five is the potential to transition patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule. Viking believes this may reduce the risk of unexpected safety or tolerability challenges and could be a valued option for both patients and clinicians.

Speaker 2

Our Phase one study was a randomized double blind placebo controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. The primary objective of the study was to evaluate the safety and tolerability of DK-two thousand seven hundred and thirty five administered as a tablet once daily for twenty eight days. Secondary and exploratory objectives included an evaluation of the pharmacokinetics of oral DK-two thousand seven hundred and thirty five as as well as changes in body weight and other metrics. The results of this study were presented at the Obesity Week Conference last November. This presentation highlighted data showing that cohorts receiving VK two thousand seven hundred and thirty five demonstrated dose dependent reductions in mean body weight from baseline ranging up to 8.2% after twenty eight days.

Speaker 2

Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day fifty seven, four weeks after the last dose was administered. Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond twenty eight days may provide further reductions in body weight. Oral VK two thousand seven hundred and thirty five also demonstrated encouraging safety and tolerability through twenty eight days of once daily dosing at doses up to and including one hundred milligrams. The majority of observed treatment emergent adverse events were mild or moderate with most reported as mild. Similarly, all gastrointestinal adverse events were reported as mild or moderate with the majority reported as mild.

Speaker 2

Based on these results, Viking designed and recently initiated the Phase II trial called the Venture Oral Dosing Trial to evaluate longer term dosing with the tablet formulation in subjects with obesity. The Venture Oral Dosing Trial is a randomized double blind placebo controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for thirteen weeks. The trial will enroll approximately two eighty adults who are obese or adults who are overweight with at least one weight related comorbid condition. Patients will be evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study will assess the percent change in body weight from baseline after thirteen weeks of treatment.

Speaker 2

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We are pleased to have the Venture oral dosing trial underway and we expect to report data from this study in the second half of twenty twenty five. Turning to our other metabolic programs, I'll provide a brief update on our MASH and rare disease programs, starting with our VK2809 program. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta isoform of the receptor. In 2024, we announced final data from a fifty two week study of VK2809 in patients with biopsy confirmed MASH and fibrosis.

Speaker 2

This study called VOYAGE evaluated as a primary endpoint the change in liver fat following twelve weeks of once daily treatment with VK2809. Secondary endpoints included assessments of histologic changes following fifty two weeks of treatment. In 2023, we reported that the study had successfully achieved its primary endpoint with patients who received VK2809 demonstrating statistically significant mean reductions in liver fat from baseline to week twelve as compared with placebo. In June of twenty twenty four, Viking announced the successful achievement of the trial secondary endpoints with VK2809 treated patients demonstrating statistically significant and best in class improvements in MASH resolution rate, fibrosis stage and the combination endpoint of MASH resolution and fibrosis improvement compared with placebo. The final results from the VOIAGE study were presented last November in an oral late breaker presentation at the annual meeting of the American Association for the Study of Liveracies.

Speaker 2

In the fourth quarter of twenty twenty four, we completed an end of Phase II meeting with the FDA to discuss the next steps for VK2809 in NASH. Feedback from this meeting was helpful in outlining the future clinical paths for this program and we remain interested in exploring partnering opportunities for further development. Turning to our fourth clinical program, in October 2024, we reported positive results from a twenty eight day Phase 1b study of our small molecule drug candidate VK0214 in patients with the rare neuromuscular disorder called X linked adrenoleukodystrophy or XALD. Like VK2809 VK0214 is also an orally available small molecule that is selected for the beta isoform of the thyroid hormone receptor. XALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a peroxisomal transporter of very long chain fatty acids.

Speaker 2

As a result, patients are unable to efficiently metabolize these acids and their accumulation is believed to contribute to the onset and progression of XALD. Activation of the thyroid hormone receptor beta has been shown to increase the expression of an important compensatory transporter of very long chain fatty acids, leading to improved metabolism and clearance of these compounds. Our Phase 1b trial was a multicenter, randomized, double blind, placebo controlled international study in men with the adrenomyeloneuropathy or AMN form of XALD. The study enrolled patients across three cohorts, placebo and VK0214 doses of twenty milligrams and forty milligrams daily. The primary objectives were to evaluate the safety and tolerability of DK0214 in subjects with AMN.

Speaker 2

An exploratory objective was to evaluate the effects of VK0214 on plasma levels of very long chain fatty acids. The data from this study showed that treatment with VK0214 resulted in statistically significant reductions in mean plasma levels of very long gene fatty acids at both the twenty milligram and forty milligram doses compared to placebo. Plasma levels of the important 26 carbon very long gene fatty acid were reduced by approximately 38% relative to placebo after four weeks of once daily dosing. In addition, subject to receive VK0214 experienced reductions in other important plasma lipids. Mean reductions relative to baseline and placebo were observed for LDL cholesterol, apolipoprotein B and lipoprotein A.

Speaker 2

Importantly, VK0214 also demonstrated encouraging safety and tolerability with treatment emergent adverse events generally reported as mild to moderate. As there is currently no pharmacologic treatment available for XALD, we are very pleased to achieve these first in class results and we'll look to partner this important program with an organization that has the appropriate expertise in rare disorders. Finally, in June of twenty twenty four, at the annual meeting of the American Diabetes Association, we announced data from a new program targeting novel agonists of the amylin receptor for the potential treatment of obesity. We are pleased with the progress made to date with this program and we expect to file an IND and initiate a Phase one clinical trial later this year. Moving to corporate and financial matters, as Greg discussed in his comments, we completed 2024 with a strong balance sheet and over $900,000,000 in cash.

Speaker 2

This provides us with the runway to complete Phase III trials for the VK2735 obesity program, as well as aggressively pursue clinical development with our other programs. In conclusion, 2024 was a year of exciting clinical successes at Viking. We begin 2025 in a strong position with more valuable clinical assets than at any time in Viking's history and we are confident in our position for future success. Going forward, the company will prioritize our VK2735 program and we are happy to be advancing both the subcutaneous and oral formulations of this compound in the clinic. We plan to initiate Phase III trials with the subcutaneous formulation in the second quarter and we expect to report data from the ongoing Phase II venture oral dosing trial in the second half of the year.

Speaker 2

In addition, we plan to file an IND for our novel amylin agonist program later this year and look forward to moving this program into clinical development. Based on our strong financial position, we plan to continue an aggressive development pace with each of these programs. We We look forward to providing further updates in the month ahead. This concludes our prepared comments for today. Thanks very much for joining us and we'll now open the call for questions.

Speaker 2

Operator?

Operator

We will now begin the question and answer session. Our first question comes from Ryan Bochner with Raymond James. Please go ahead.

Speaker 4

Thank you very much for the question.

Speaker 5

I wanted to see if

Speaker 4

I could get some more detail from the discussion of in the feedback at the end of Phase two meeting, particularly details on the potential number or size or maybe even potential comparator arms for the Phase three studies that you plan to initiate next quarter? Thank you.

Speaker 2

Yes. Thanks, Ryan. We'll provide more detail on the study design when we announce the initiation, but the size would certainly conform to guidance, which requires at least 4,500 people in the Phase three program. For these two studies, there will be one in obese subjects and one in obese subjects with Type two diabetes. We would plan to use multiple doses and conform in that we would target a fifty two week treatment window as well.

Speaker 2

But we'll provide further details on the doses and other items when the trials initiate.

Speaker 4

Got it. Thank you very much, Brian.

Speaker 3

Thanks, Ryan.

Operator

And the next question comes from Mike Alls with Morgan Stanley. Please go ahead.

Speaker 6

Good afternoon and thanks for taking the question. Maybe just on the Phase three obesity study, it looks like you narrowed the timing for the start there to 2Q versus first half twenty five previously. Just curious what the rationale for that and kind of the remaining steps to getting that study going? Thanks.

Speaker 2

Yes. Thanks, Mike. We're just it's primarily logistical making the formulation, making the drug product to enter into the study. So having better visibility on the timelines for production of the clinical material allows us to focus the time the window a little bit better. But everything's going according to plan.

Speaker 2

So nothing no issues, just a big complicated exercise and we're well into it though.

Operator

Great. Thank you.

Speaker 2

Thanks, Mike.

Operator

The next question comes from June Lee with Truist Securities. Please go ahead.

Speaker 7

This is Asim Rana on for June Lee. Congrats on the quarter and thanks for taking the questions. Are these studies going to be standard weight loss studies or are you looking to include anything differentiating? And then how long do you think it will take to recruit patients? And then I have a follow-up.

Speaker 2

Yes, sure. Well, the primary endpoint would be change in body weight. The diabetes study will also include glycemic endpoints as you typically would in a Type two diabetes study, but primary endpoint would be change in body weight.

Speaker 5

I forgot the second question.

Speaker 7

Just how long it will take to recruit patients?

Speaker 2

Yes. We can't give guidance on that just yet. We need to start the study and understand timelines to site initiation as well as what the enrollment queue looks like. But so we'll be able to provide that later, but can't progonosticate right now.

Speaker 7

Okay. Just one more. Are these studies starting concurrently? And have you secured API for both Phase three studies?

Speaker 5

Thank you.

Speaker 2

Yes. We do have the API for both studies, enough API to get through the Phase three program. And we do hope to start them as close as possible to concurrent as we can.

Speaker 5

Thank you.

Speaker 2

Thanks, Austin.

Operator

And the next question comes from Jay Olson with Oppenheimer. Please go ahead.

Speaker 8

Hey, congrats on all the progress and thanks so much for taking the question. I think Brian you had mentioned that you were planning to test monthly for the subcu formulation later this year. Can you just talk about your thoughts on the study design and whether or not that can be implemented into Phase three and eventually get into the label? And then I had one follow-up if I could.

Speaker 2

Yes. Thanks, Jade. The long term goal would be to have something in the label whether or not it would be in the initial NDA, too early to tell right now. The study that we'd like to initiate will be a study where we rapidly titrate people to a high dose of VK two thousand seven hundred and thirty five and then transition them from the weekly to the monthly cadence and really look for weight regain. How does we're not anticipating further weight loss, but how does maintenance work at this less frequent dosing interval?

Speaker 8

Okay, great. Thank you. And then further along the lines of maintenance dosing, I think you mentioned there was an option to transition from sub Q to the oral formulation. Is that something that you were planning to do in a separate study?

Speaker 2

Yes. So ideally this would be in the same study. So we would transition some to a low dose oral, but we're working through the protocol currently. And the plan would be we do the first study as sort of a PK exploratory study and then follow it up with a little bit longer term study to look at longer term maintenance effects.

Speaker 8

Okay, great. Thanks. That's super helpful. Appreciate taking the questions.

Speaker 3

Thanks a lot, Jay.

Operator

And the next question comes from Annabel Samimy with Stifel. Please go ahead.

Speaker 9

Hi. Thanks for taking my question. Just a couple for me. For the Phase two oral ventura trial, it looks like it's a pretty broad dose range still. And any reason why it's not more narrow?

Speaker 9

And at the highest dose is that something that you'll realistically be pursuing or you're still just testing the maximum tolerability again?

Speaker 2

Yes. Thanks, Edible. TBD on what the dose range would be in a subsequent study. We're just getting this one underway. But we really want to know when you treat for a longer period of time, do these lower doses continue to mature on body weight reduction?

Speaker 2

It looked like the lower doses did have that in the Phase one study, but it was so short and so small that it's really hard to tell. It does seem like as we get further accumulation with longer term dosing, you should see this sort of maturing efficacy signal, but we haven't done the study yet. So we'll see how it turns out.

Speaker 9

And at the highest dose, are you comfortable that you've tested maximum tolerability or are you just trying to push as broad a dose range as you can?

Speaker 2

Yes. The Phase one study was very well tolerated at one hundred. We pushed a little bit higher here and we were okay to do that. So could we go even higher? I don't know.

Speaker 2

We only proposed one hundred and twenty. I think we could probably defend higher doses, but we balance that against what we know about the accumulation rate as being slow and almost certainly we're not at steady state at twenty eight days. So it's a balance where you pick that top dose, but one hundred and twenty seems to be it'll be an interesting dose to look at.

Speaker 9

Okay. And then just as a follow-up, any updates on the manufacturing agreement and why it might be taking so long to finalize?

Speaker 2

Yes. Spending a lot of time on manufacturing, we continue to work toward a comprehensive agreement or set of agreements. And the goal is really to enable the launch of a substantial commercial product and complicated discussions, but making a lot of good progress and we'll have more to say at the appropriate time.

Speaker 9

Thank you.

Speaker 2

Thanks Annabel.

Operator

And the next question comes from Monye Mompanyi with B. Riley Securities. Please go ahead.

Speaker 10

Yes, good afternoon. Thanks for taking our questions and congrats on the operational progress. Just on the ventraloral Phase two study, appreciate the rationale for choice of top dose selection there. Are you able to comment Brian on the thirteen week weight loss expectation? And if you could also help us think about the cost of goods sold based on the manufacturing contracts you're working on to secure the API would be helpful.

Speaker 10

And then I have a follow-up.

Speaker 2

Yes. I'd say on both of those, little too early to tell. We can't really predict where the weight loss might land after thirteen weeks. When we look at the four week graphs, you can see the trends continuing downward, but where do those go from here? It's really hard to predict.

Speaker 2

With COGS, I think it's premature to start discussing COGS as we're in a Phase two trial with the program. We certainly wouldn't want to target a product that isn't profitable though.

Speaker 10

Okay, got it. And then the concepts like weight regain or lean muscle mass preservation, any plans to study that as part of these Phase two studies, the oral and the once monthly sub subQ or is that more TBD as those studies progress?

Speaker 2

Well, the maintenance study that I think Jay asked about would be really to target weight regain. So that's where we dose people using the weekly regimen up to a high dose and then transition them to a monthly injection or a low dose daily oral. And the primary objective is to understand how weight regain manifests after you make that transition to either the monthly or the low dose oral.

Speaker 10

Lean muscle mass preservation, is that more Hamelin focused?

Speaker 2

No, we will do DEXA in the Phase three program, but no intention at this point to evaluate like our five thousand two hundred and eleven molecule for muscle preservation. But we will be doing dexes. I think everybody's doing dexes in their Phase three programs on a subset of patients.

Speaker 10

Got it. And lastly on 02/1700 for NASH, obviously you've been working through the post end of Phase II feedback and obviously having strategic discussions. Is there any update to how maybe the counterparty feedback might be coming as obviously there have been slew of positive commercial and clinical updates in that space that could warrant a very positive return on investment. And maybe the complexity is not as bad as maybe it was thought a few years ago? Thanks for taking my questions.

Speaker 2

Yes, sure. Well, hard to comment on discussions around partnering for really either of the assets. We had a very busy schedule at JP Morgan and we're in the follow-up period now, but nothing further to say at this time on partnering. I think the overhang with the MASH program is the requirement for biopsies and that does complicate Phase three trials, but we'll see where some of the conversations lead.

Speaker 10

Got it. Thank you.

Speaker 2

Thanks, Mayank.

Operator

And the next question comes from Biren Amin with Piper Sandler. Please go ahead.

Speaker 11

Yes. Hi, guys. Thanks for taking my question. Maybe let me just start with the monthly subcu dose study. Is the plan to evaluate the ten milligram and fifteen milligram doses?

Speaker 11

And how are you thinking about timing at the start of the monthly subcu relative to the Phase three weekly subcu study?

Speaker 2

Yes, thanks. We're not going to disclose the doses until we get to the study initiation, but we would intend to keep people on the weekly for probably four weeks before we transition them to the monthly. But all those details we would disclose when we start the study.

Speaker 11

Got it. And then maybe a follow-up question on the Amylin program, what needs to be completed for IND submission this year?

Speaker 2

Well, all of the IND enabling work, particularly the talks work, but we hope to have that done to enable an IND filing this year.

Speaker 11

Great. Thanks.

Speaker 2

Thanks, Biren.

Operator

And the next question comes from Hardik Parikh with JPMorgan. Please go ahead.

Speaker 5

Hey, Brian. Thanks for all the updates today. Couple of questions. First is on the subcu program. So I believe it was at our conference in January where you announced that the first time that you would also be studying it in the Type two diabetes plus obesity population.

Speaker 5

Was that originally part of your plan or was that more of a result of the FDA meetings you've had? And then the second one is on the oral program. You said data in the second half of the year. Is there any kind of thought process on whether that data will be headline data or could we see a full readout in the second half? Thank you.

Speaker 2

Yes. Thanks, Hardik. The data timing, generally we report top line data when it's available and then the final data are generally reported later. So when we have the key elements of the top line data set, which will probably be body weight change and safety profile, we would intend to release it. With the Phase III trial choices, the playbook there is it's not unique to us.

Speaker 2

It's generally a Phase III study in obese subjects and then a separate Phase three study in obese subjects with Type two diabetes. And the obesity study is the larger of the two diabetes will be the smaller of the two, but that enables some discussion of glycemic control in the label.

Speaker 5

Okay. And just one more, just follow-up on the Amylin program. You're still deciding to which candidate you're going to kind of take forward. Is it possible that it could be one of those assets that you disclosed, I believe, back in ADA last year?

Speaker 2

Yes, it's possible. We have a number that look really interesting, but that's possible, yes.

Speaker 5

Okay. Thank you.

Speaker 3

Thanks, Hardi.

Operator

And the next question comes from Andy Hsieh with William Blair. Please go ahead.

Speaker 12

Thanks for taking our questions. Just curious about your view on PK as data were presented at the Obesity Week. So first looking at the accumulation, I'm curious if there is like a multiple that you're looking for in the initial phase that would lend evidence to potentially longer dosing interval like you mentioned the monthly dosing interval? And then also in terms of the plasma level, is there like a minimum that you're looking at the end of week four to give you confidence that the weight regain would be minimized?

Speaker 2

Yes, good questions. The way we looked at starting with

Speaker 13

the second

Speaker 2

question, it seems as though when we look at that two point five mg dose over thirteen weeks that leads to 9% weight loss, which is pretty good. So it feels like if you can maintain plasma levels in the neighborhood of that two point five mg dose after four weeks, four weeks from the prior dose, you're probably in a range that will prevent any significant weight gain. And so that's just kind of high level the way we're looking at it. And yes, there's more numbers behind that, but that's kind of the way we consider it. With the accumulation, interesting when you look at the accumulation graphs, even the five milligram cohort after thirteen weeks, it's still accumulating.

Speaker 2

And I think that speaks to the highly differentiated half life we have that allows accumulation to happen even though you've been affixed at that five milligram dose for ten weeks in that study, there's still an accumulation ongoing. So where does it go at higher doses? We're not quite sure, but I think it suggests that the thirteen week data probably understates the long term efficacy of what's possible.

Speaker 12

And just a quick follow-up Brian. I'm curious with the accumulation graph that you showed, would you be able to provide the follow-up period? So for example, like a sixteen week follow-up with the accumulation PK or that's simply not measured in the venture study?

Speaker 2

Yes. Well, that is actually the graph below it in the poster. When you look at the plasma level decay, that's over the following seven weeks. So that would be nineteen weeks total in that I mean, the final time point in that second graph would represent nineteen weeks from day one of the study, if that makes sense. So starting with the

Speaker 12

Right, right. That's right. That's right.

Speaker 7

Okay. That makes sense.

Speaker 5

Okay, great. Thanks so much, Ryan.

Speaker 2

Yes. Thanks, Andy.

Operator

And the next question comes from Yale Jen with Laidlaw and Company. Please go ahead.

Speaker 13

Great. Thanks for taking the questions and congrats on the progress. Just a few quick ones. The first is that for the Phase three study in terms of Type two diabetes patients, would you also potentially seek a label on the diabetes alone or simply just that part of the obesity? Then I have a follow-up.

Speaker 2

Yes. Thanks, Jill. It's a great question. Really, we wouldn't be submitting a Type two diabetes package for approval for treatment of Type two diabetes. It's for inclusion in an obesity label in people with obesity and Type two diabetes.

Speaker 13

And a follow-up question here is that in terms of material preparing, is auto injector part of that? And if so, what's the situation there?

Speaker 2

Yes. We do plan to introduce an auto injector in the Phase III program. So we would anticipate the product to launch as an auto injector.

Speaker 13

And do you need to do a bridging study on that or that's not necessary if you don't start with the auto injector for the Phase III?

Speaker 2

Yes, we probably would do a bridging study just to make sure that we have bioequivalence with the auto injector. So I think that would be the intention there.

Speaker 13

Okay, great. Thanks a lot. And again congrats on all the progresses.

Speaker 2

Thanks a lot,

Operator

Yale. Our next question comes from Justin Zelman with BTIG. Please go ahead.

Speaker 14

Thanks for taking the questions and congrats on the updates here. Brian, I wanted to ask about the upcoming late stage oral small molecule B. C. Readout in the field and just your latest thoughts on the benefits associated with and the scalability of peptide API as compared to small molecules?

Speaker 2

Yes. So hard to predict the data upcoming. It's always I always do a bad job at that. But we'll wait for it just like everybody else. As far as scalability of peptides versus small molecules, I think there is some misperception out there that the small molecules are universally easier to make than peptides.

Speaker 2

That's I mean, I'm a small molecule chemist, that's totally false, but I know that's the perception. Peptide chemistry is pretty simple. It's pretty low tech. It's scalability that is the challenge, the chemistry is not. And we're, I think, comfortable that we'll be able to produce scale that supports a multibillion dollar franchise.

Speaker 14

Thanks again, Brian. Congrats again.

Speaker 2

Thanks, Justin.

Operator

And the next question comes from Fiona Gia with Jefferies. Please go ahead.

Speaker 9

Hi, James. Thanks for taking the question, and congrats on the quarter. So my question is on the amylin program. Can you just comment on the like characterization of the compound that you selected? Because I seem to remember from an ADA, most of the compounds seem to follow a balanced profile, but I think there are, like, one or one or two that are more Emblem bias.

Speaker 9

Can you comment on the like any characterization of the DC that you might select?

Speaker 2

Yes. All of them are well, we do have a range, but the ones that are of greatest interest are much more balanced more toward that one to one when you look at the I think we look at calcitonin to Amylin III pretty much one to one maybe up to three or five to one, but as close to as possible to one to one. I'm not sure that answers the question, but that's okay.

Speaker 9

Yes, very helpful. Thank you.

Operator

Thanks, Yonah. This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Speaker 1

Thank you very much for joining us today. We look forward to updating you again in the coming months. Have a good afternoon.

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

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Earnings Conference Call
Viking Therapeutics Q4 2024
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