Viking Therapeutics Q1 2026 Earnings Call Transcript

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Provided by Quartr
April 29, 2026

Key Takeaways

  • Positive Sentiment: VANQUISH Phase III enrollment complete — both subcutaneous VK2735 trials are fully enrolled (~4,500 in VANQUISH‑1; ~1,000 in VANQUISH‑2), have introduced an auto‑injector, and remain on track toward the 78‑week primary endpoints (company‑reported).
  • Positive Sentiment: Oral VK2735 advanced to Phase III — after End‑of‑Phase‑2 feedback and positive phase II oral data (up to ~12.2% mean weight loss), Viking plans to initiate oral Phase III in Q4 2026, positioning an oral dual GLP‑1/GIP agent in the market.
  • Positive Sentiment: Maintenance dosing study expanded and accelerated — the subcutaneous maintenance cohorts were increased from 4 to 8, enrollment completed rapidly, and Viking expects subQ maintenance data in Q3 2026 to inform multiple maintenance arms in the VANQUISH extensions (company aims for less‑frequent dosing options).
  • Negative Sentiment: Material increase in expenses and cash burn — Q1 R&D jumped to $115.2M (vs $41.4M) driving a net loss of $158.3M ($1.37/share) and cash of ~$603M at quarter end (down from $706M); management says cash runway extends into 2028 but Q1 spending exceeded prior expectations.
  • Positive Sentiment: VK3019 amylin program moving to clinic — an IND was filed for the amylin agonist VK3019 with Phase I (SAD/MAD) expected to start later this quarter, adding a potential complementary mechanism to Viking’s obesity franchise.
AI Generated. May Contain Errors.
Earnings Conference Call
Viking Therapeutics Q1 2026
00:00 / 00:00

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Operator

Welcome to the Viking Therapeutics Q1 2026 financial results conference call. As a reminder, this conference call is being recorded today, April 29th, 2026. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Thank you, and over to you.

Stephanie Diaz
Stephanie Diaz
Head of Investor Relations at Viking Therapeutics

Hello and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO, and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, April 29th, 2026, 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. 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.

Stephanie Diaz
Stephanie Diaz
Head of Investor Relations at Viking Therapeutics

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.

Brian Lian
President and CEO at Viking Therapeutics

Good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the Q1 ended March 31st, 2026 and review recent progress with our pipeline programs and operations. During the Q1, we made significant progress with our obesity franchise, highlighted by our lead compound, VK2735, a dual agonist of the GLP-1 and GIP receptors. As we have previously reported, in June 2025, following the positive results from our phase II VENTURE study, Viking initiated its phase III VANQUISH clinical program evaluating VK2735 dosed as a weekly subcutaneous injection. The phase III VANQUISH program includes two studies: VANQUISH-1, evaluating the treatment of adults with obesity, and VANQUISH-2, evaluating the treatment of adults with obesity and type 2 diabetes.

Brian Lian
President and CEO at Viking Therapeutics

Enrollment in the VANQUISH-1 trial was completed in the Q4 of last year. During the Q1 of 2026, we were pleased to announce the completion of enrollment in the VANQUISH-2 trial. Both studies continued to proceed on track. In the Q1, the company made progress with its oral VK2735 program. Following an end-of-phase II meeting with the FDA and based on the positive top-line results reported in our phase II VENTURE oral dosing study, the company elected to advance oral VK2735 into phase III clinical development, which we plan to initiate later this year.

Brian Lian
President and CEO at Viking Therapeutics

Concurrent with the planning and execution of our subcutaneous and oral registration programs, in October 2025, Viking initiated a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly, every other week, or weekly dosing. This trial has advanced rapidly with enrollment completed in the Q1 of this year, less than three months after initiation. We expect to report the results of this study in the Q3. Finally, in the Q1, we filed an IND with our novel amylin receptor agonist and pending clearance are on track to initiate the clinical development of this compound later this quarter. I'll have additional comments on our operations and development activities following a review of our financial results for the Q1 ended March 31st. For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Greg Zante
CFO at Viking Therapeutics

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the Q1 ended March 31st, 2026. Research and development expenses were $115.2 million for the three months ended March 31st, 2026, compared to $41.4 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, consultants, salaries and benefits, and preclinical studies, partially offset by a decrease in expenses related to stock-based compensation. General and administrative expenses were $14 million for the three months ended March 31st, 2026, compared to $14.1 million for the same period in 2025.

Greg Zante
CFO at Viking Therapeutics

The decrease was primarily due to decreased expenses related to legal and patent services and stock-based compensation, partially offset by increased expenses related to consulting, salaries and benefits, and scientific and disease education. For the three months ended March 31st, 2026, Viking reported a net loss of $158.3 million or $1.37 per share, compared to a net loss of $45.6 million or $0.41 per share in the corresponding period in 2025.

Greg Zante
CFO at Viking Therapeutics

The increase in net loss for the three months ended March 31st, 2026, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses compared to the same period in 2025. Turning to the balance sheet, at March 31st, 2026, Viking held cash equivalents and short-term investments of $603 million, compared to $706 million as of December 31st, 2025. This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Greg. I'll now provide an update on Viking's clinical and operational progress, beginning with our lead obesity program, VK2735. VK2735 is a dual agonist of the Glucagon-like peptide-1, or GLP-1 receptor, and the Glucose-dependent insulinotropic polypeptide, or GIP receptor, that has demonstrated promising efficacy, safety, and tolerability across multiple clinical trials. As I mentioned in my opening comments, Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity, as well as evaluating a novel maintenance dosing protocol to support long-term weight management. During the Q1, Viking made substantial progress in each of these areas. With respect to the subcutaneous VK2735 program, Viking's prior phase I and phase II trials successfully achieved their primary and secondary endpoints, demonstrating significant weight loss compared with placebo, as well as an impressive safety, tolerability, and pharmacokinetic profile.

Brian Lian
President and CEO at Viking Therapeutics

In the phase I subcutaneous study, subjects receiving VK2735 achieved up to approximately 8% weight loss from baseline after four weekly doses, with no signs of plateau. In the phase II VENTURE study, patients demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after 13 weekly doses, again, with no signs of plateau. Importantly, the VENTURE study also showed VK2735 to be safe and well-tolerated through 13 weeks of dosing, with the majority of treatment-emergent adverse events characterized as mild or moderate and resolving quickly. These results were highlighted in a presentation at the 2025 ObesityWeek conference last November. The final results were also published in January 2026 in Obesity, the peer-reviewed journal of The Obesity Society.

Brian Lian
President and CEO at Viking Therapeutics

Following the VENTURE phase II study, Viking held a Type C meeting with the FDA and subsequently an end-of-phase II meeting with the agency. Based on feedback from these meetings, in June of last year, the company initiated the VANQUISH phase III registration program, evaluating subcutaneous VK2735 in patients with obesity. The VANQUISH program consists of two clinical trials, one in adults with obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled, multi-center trial designed to assess the efficacy and safety of VK2735, administered by subcutaneous injection once weekly for 78 weeks. Enrollment in each of these trials was rapid, with the VANQUISH-1 study enrolling approximately 4,500 patients by November 2025, approximately five months after trial initiation. Enrollment in the VANQUISH-2 study was completed in the Q1, enrolling approximately 1,000 patients.

Brian Lian
President and CEO at Viking Therapeutics

Participants in each trial are being randomized to weekly doses of 7.5 mg, 12.5 mg, 17.5 mg, or placebo. Primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15%, and 20% weight loss. Each study will include an extension portion, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period, including patients who were randomized to placebo for the initial 78-week treatment period.

Brian Lian
President and CEO at Viking Therapeutics

Another important achievement during the Q1 for both the VANQUISH-1 and VANQUISH-2 studies was the successful introduction of an auto-injector device into the trials. As a reminder, both VANQUISH-1 and VANQUISH-2 were initiated using a vial and syringe for administration of VK2735. In the Q4 of 2025, Viking conducted a Bioequivalence study to facilitate the introduction of an auto-injector, which we believe will add optionality to treatment and may represent a more convenient method of administration for patients. This study was successfully completed. In the Q1 of 2026, participants in both VANQUISH studies began transitioning to the auto-injector device. This transition has been proceeding smoothly. We are very pleased to now have both VANQUISH studies advancing with our state-of-the-art auto-injector. I would now like to provide an update on Viking's oral tablet formulation of VK2735.

Brian Lian
President and CEO at Viking Therapeutics

I referenced a moment ago that we believe the auto-injector device in our subcutaneous VANQUISH studies will provide optionality in treatment. The concept of optionality is becoming increasingly important based on our conversations with physicians and KOLs about treatment regimens. Every patient's weight loss journey is unique, and we consistently hear from healthcare providers about the need for flexible treatment and administration options. We have long believed that an oral tablet formulation has the potential to be an attractive option for those who prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved via weekly injection. Providing this optionality has been an important driver for the development of our oral program. Given the recent success of another oral peptide for obesity, we are even more optimistic about the promise of oral administration.

Brian Lian
President and CEO at Viking Therapeutics

Viking's prior phase I and phase II studies evaluating oral VK2735 successfully achieved their objectives. In addition to excellent safety and tolerability, our phase I study demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 daily doses. In addition, the phase II VENTURE oral dosing study of VK2735 achieved its primary and secondary endpoints, with participants receiving once daily doses of the tablet formulation demonstrating statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses above 15 mg, starting at week one and continuing throughout the 13-week treatment period.

Brian Lian
President and CEO at Viking Therapeutics

Up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss after 13 weeks, compared with only 5% of placebo-treated subjects. The tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once-daily dosing. The vast majority, 98%, of drug-related treatment emergent adverse events were characterized as mild or moderate in severity. Importantly, in the dose range we plan to explore in future studies, we believe the data show no meaningful difference in GI-related adverse events between subjects treated with VK2735 and placebo. The tolerability data from the VENTURE oral dosing study also suggests that future titration regimens starting at lower doses and utilizing longer titration intervals are likely to further improve oral VK2735's tolerability profile.

Brian Lian
President and CEO at Viking Therapeutics

As with our subcutaneous program, following the completion of the VENTURE oral dosing study, we held an end-of-phase II meeting with the FDA. Based on feedback from this meeting, the company plans to advance oral VK2735 into phase III development for the treatment of obesity. We currently expect to initiate this program in the Q4 of this year and will provide more details on study design at that time. As part of our goal to create an optimal treatment experience for patients on their weight loss journey, Viking is actively engaged with KOLs, healthcare providers, and advocates who are focused on improving the lives of those living with obesity. Through these relationships, we have the opportunity to listen to a range of stakeholders in the community and to work towards solutions that best meet their treatment needs.

Brian Lian
President and CEO at Viking Therapeutics

Viking's efforts at developing a novel maintenance dosing strategy emerged as a result of these conversations. In approaching how to best design a maintenance study, we considered the unique characteristics of the VK2735 molecule, namely its potency and unique PK profile. We believe these features may allow the development of maintenance regimens that utilize less frequent dosing than the weekly regimens used by existing agents. This could be an attractive option for those patients who have achieved their weight loss goals and are seeking to maintain that weight loss going forward. By using the same therapeutic agent for both the induction and the longer-term maintenance phase of weight management, we believe patients may experience reduced side effects compared with options that require switching between different therapeutic agents.

Brian Lian
President and CEO at Viking Therapeutics

By reducing side effects, we believe adherence to treatment may be improved, allowing patients to ultimately realize the long-term benefits of weight loss and maintenance, including improved cardiovascular health, enhanced physical function, and increased quality of life. With these goals in mind, in the Q4 of 2025, we initiated a phase I study to explore a range of maintenance dosing regimens. In this study, all subjects will receive initial weekly doses of VK2735, followed by a transition to a range of maintenance regimens or placebo. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various regimens. Exploratory endpoints will assess the change in body weight from baseline, as well as the change in body weight from the time of transition to the end of the study.

Brian Lian
President and CEO at Viking Therapeutics

The timing of this study is particularly important to our broader development program, as we believe the results from these maintenance regimens could be utilized in the upcoming 52-week VANQUISH extension studies. As a result of this timing and the importance of selecting doses for immediate use in the subcutaneous extension studies, we have bifurcated the study to focus first on the subcutaneous maintenance cohorts, followed by the oral maintenance cohorts. To this end, we've expanded the number of subcutaneous dosing arms in this study from four to eight. This increase in cohorts will provide a broad and robust data set from which to choose for inclusion in the VANQUISH extension study. Following the completion of the subcutaneous maintenance cohorts, we will continue the study to evaluate a similarly wide range of oral cohorts.

Brian Lian
President and CEO at Viking Therapeutics

We expect to report the results of the subcutaneous portion of the study in the Q3 of this year and expect to report the oral maintenance results in the H1 of next year. Moving to our other pipeline programs, Viking is also evaluating a series of novel agonists of the amylin receptor. Early data demonstrate that activation of the amylin receptor is an important potential mechanism for regulating appetite and body weight, making this program an excellent addition to our obesity franchise. In 2025, we made significant progress with our lead amylin agonist, VK3019, and we recently filed an IND for this program.

Brian Lian
President and CEO at Viking Therapeutics

Pending clearance, we expect to initiate a phase I clinical trial for VK3019 later this quarter. As VK2735 advances through phase III development and toward potential approval and commercialization, we continue to thoughtfully grow our organization to meet the opportunities and challenges that lie in the not too distant future. Key recent additions to our team include staffing across a range of scientific and operational roles, including supply chain management, manufacturing, and quality. To coalesce these functions into an efficient and effective commercialization strategy, the company announced in the Q1 the appointment of Neil Aubuchon as its first Chief Commercial Officer. Neil brings to Viking more than 20 years of industry experience, including nearly 17 years at Eli Lilly. He has held leadership roles across global commercial and marketing functions in the cardiometabolic space, making him uniquely qualified to lead our commercial strategy for VK2735.

Brian Lian
President and CEO at Viking Therapeutics

We are excited to have him on board to lead this critical operation. As always, Viking remains vigilant in managing the company's balance sheet to ensure we're able to successfully execute our objectives. As Greg reported a few minutes ago, the company held approximately $600 million in cash at the end of the Q1, which allows us to reach important corporate milestones, including the completion of our ongoing phase III obesity trials, as well as to pursue development of our additional programs. In conclusion, I'm happy to report that the advances and momentum of 2025 have continued through the Q1 of 2026. Looking ahead, we plan to have both our subcutaneous and oral VK2735 programs in phase III registration trials during the year.

Brian Lian
President and CEO at Viking Therapeutics

Our maintenance dosing trial continues, and we look forward to reporting data from this study in the Q3. With respect to our earlier stage pipeline, we expect to initiate a phase I trial for our amylin agonist, VK3019, shortly. Operationally, as our programs continue to progress toward potential approval and commercialization, our organization continues to evolve as well. Our team is focused on executing a timely and strategic expansion plan that ensures that Viking has the partnerships, vendors, and in-house expertise required to succeed in all areas, including clinical, regulatory, manufacturing, and commercialization. Finally, we expect to offer industry-leading options with respect to administration, dosing, and maintenance that physicians and patients need to optimize the path to individual weight loss goals and long-term health. We look forward to reporting our advances on these fronts in the coming months. This concludes our prepared comments for today.

Brian Lian
President and CEO at Viking Therapeutics

Thanks for joining. We'll now open the call for questions. Operator?

Operator

Thank you. We will now begin the question and answer session. Please note that we have a large number of participants in the queue. The company will do its best to answer as many questions as possible. Please wait for a moment as we assemble our roster. We have the first question from the line of Steve Seedhouse from Cantor Fitzgerald. Please go ahead.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Cantor Fitzgerald

Great. Good afternoon. Thank you so much. First is just on the change from four to eight sub-Q maintenance cohorts in the ongoing study. I was hoping you could just elaborate on what like doses and intervals the new eight cohorts are testing. If you wouldn't mind just quickly commenting on R&D just for our modeling, maybe connecting the dots between the like $160 million-ish or so net loss versus about $100 million in net cash change. I think folks specifically were expecting R&D to come down a bit this quarter from some one-time phase III startup costs. Just would hope if you could clarify if you're expecting R&D costs to come down next quarter or if this is maybe the new run rate. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Steve. This is Brian. I'll take the clinical question, and Greg will take the cash question. On the maintenance study, just given the importance of this study for implementation into the VANQUISH extensions, we decided to extend the cohorts and then defer the oral dosing to a second part. We'll retain those first four cohorts that we had earlier, which were 22.5 mg, 20 mg, 17.5 mg monthly, as well as 7.5 mg every other week. But we've added 15 mg monthly, 10 mg monthly, 10 mg every other week, and 5 mg every other week. We got a nice range of every other week, and a broader range of monthly doses. Greg.

Greg Zante
CFO at Viking Therapeutics

Steve, on OpEx and cash, for one, the disconnect on that a bit is really timing, a function of timing. There just were, you know, higher expenses and cash usage, and, you know, that stuff evens out over time. Looking ahead and this next quarter, I think our cash usage and expense will be, you know, around where we were in quarter one, maybe a bit lower. Toward the H2 of this year, I would expect things to taper down a little bit. The overall usage is still in line with our projections from our last call. We would anticipate having cash, you know, into 2028 and through the catalysts we've talked about, including the oral phase III data points. We remain funded as we expected, but we probably used a little bit more in the Q1 than I anticipated, but we are on track.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Cantor Fitzgerald

All right. Thanks so much.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Steve.

Operator

Thank you. We have the next question from the line of Thomas Smith from Leerink Partners. Please go ahead.

Nat Charoensook
Nat Charoensook
Analyst at Leerink Partners

Hi, this is Nat Charoensook on for Thomas Smith. We have a couple of questions. The first one, now that both VANQUISH-1 and VANQUISH-2 are fully enrolled, what baseline characteristics are you seeing, and are they consistent with your expectations? Are you seeing any differences in enthusiasm, screen failure rates or retention between VANQUISH-1 and VANQUISH-2? We have a follow-up.

Brian Lian
President and CEO at Viking Therapeutics

Yeah, sure. We're actually gonna present the baseline demographics at two conferences this year. I think in the European Congress on Obesity, we'll have the VANQUISH 1 demographics, and then at EASD, we'll have VANQUISH 2 demographics. I'll defer to those conferences for the demographic disclosures. I don't think anything's kind of out of the ordinary with respect to the population relative to other studies. They're kind of down the middle of the fairway.

Nat Charoensook
Nat Charoensook
Analyst at Leerink Partners

Got it.

Brian Lian
President and CEO at Viking Therapeutics

Yeah, go ahead. Sorry.

Nat Charoensook
Nat Charoensook
Analyst at Leerink Partners

Yeah, the second one, like how should investors think about the expected weight loss in type 2 diabetic versus non-diabetic obesity patients?

Brian Lian
President and CEO at Viking Therapeutics

Oh, yeah. Hard to know. It's up to the individual investor to make that, you know, estimation. Generally, type 2 patients are a little bit more resistant to weight loss than non type 2 patients. I don't think that would be surprising to see in the weight loss data from these studies. I think, you know, probably see a more robust effect in the straight obesity and maybe a little bit lower efficacy in the type 2 diabetics, just like everybody else has shown.

Nat Charoensook
Nat Charoensook
Analyst at Leerink Partners

Got it. Finally, like on the phase III initiation of oral VK2735, which is now expected in Q4 2026, what changed versus prior expectation for Q3 2026?

Brian Lian
President and CEO at Viking Therapeutics

Nothing really changed. You know, we're moving incredibly fast and scaling up dramatically here. You know, as you do that, you learn a lot about the process and efficiencies. You know, making 100 tablets is different than making a million tablets. You learn a little bit more about engineering processes and et cetera, that get optimized along the way just to ensure you got the most efficient and cost-effective methods in place. All of that takes some time. We feel good about the supply chain and the capacity and efficiencies and where we're at in the development cycle. Look forward to initiating as early as possible in the Q4.

Nat Charoensook
Nat Charoensook
Analyst at Leerink Partners

Thank you. This is very helpful.

Brian Lian
President and CEO at Viking Therapeutics

Thanks.

Operator

Thank you. We have the next question from the line of Michael from Morgan Stanley. Please go ahead.

Analyst at Morgan Stanley

Good afternoon. Thanks for taking the question. Maybe just to follow up on the maintenance study. You know, obviously you're testing a number of different regimens, subQ, oral, et cetera. Just curious, you know, early in the study if you're getting a sense of, you know, which one of those options that's sort of resonating most with the patients and, you know, could it be the monthly dosing or is that a wrong interpretation? Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Oh, yeah. You know, we're not really getting that level of feedback, Mike. It would be hard to interpret because it's a placebo-controlled study. We made the addition of the subQ cohorts before anybody had transitioned to the maintenance setting. No one had actually entered into the oral maintenance portion. We made the decision and expanded the subQ portions. We'll do the oral then in a separate part of the study.

Analyst at Morgan Stanley

Got it. Very helpful. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Mike.

Operator

Thank you. We have the next question from the line of Ryan Deschner from Raymond James. Please go ahead.

Ryan Deschner
Ryan Deschner
Director of Biotechnology at Raymond James

Hi. Thanks for the question. What were the key factors that went in selecting the 19-week period as the subQ induction time period for the maintenance study? I have a follow-up.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Ryan. It was really driven by the time to titrate to the 22.5 mg dose. That was the highest dose, and we wanted to first get people up there and then keep them there for I think it's a three-week treatment time there, and then transition everybody to the maintenance at the same time point. That was sort of the rate limiting factor, the time it took to titrate to the highest dose.

Ryan Deschner
Ryan Deschner
Director of Biotechnology at Raymond James

Got it. That's helpful. I guess, just wanted to kind of feel out what the odds might be of would you add in additional, oral cohorts, potentially later on, in the maintenance study? Is that something that could be on the table?

Brian Lian
President and CEO at Viking Therapeutics

Yes, absolutely. Great question. We will be adding more cohorts to the oral portion of the study. We'll probably look at a few more doses as well as potentially alternative regimens.

Ryan Deschner
Ryan Deschner
Director of Biotechnology at Raymond James

Thanks, Brian.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Ryan.

Operator

Thank you. We have our next question from the line of Annabel Samimy from Stifel. Please go ahead.

Annabel Samimy
Annabel Samimy
Managing Director and Senior Analyst at Stifel

Hi. Thanks for taking my question. Obviously with the addition of new cohorts, your maintenance study seems to have gotten a little bit more involved. I guess I'm trying to figure out what the various possibilities are for that extension trial. Are you gonna select one of these cohorts? Are you gonna give the option for multiple cohorts going into the extension, the extension study? Like, what is the purpose of having all these eight additional cohorts? I'm just trying to understand exactly what you intend to do with these cohorts going forward. Is it just for information purposes and their selection in the extension study? Then, I guess taking it forward, are you gonna develop it any further past this extension study for possible inclusion in the label?

Annabel Samimy
Annabel Samimy
Managing Director and Senior Analyst at Stifel

Is it just developing a wealth of data for physicians to draw on and sort of use the data as an art, rather than a very prescriptive formula for maintenance for these patients?

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Annabel. Two great questions. I think with the second question, at a minimum, we would hope to be able to publish the extension data from the VANQUISH extension utilizing some of these maintenance cohorts. That would provide valuable information in the form of publications to clinicians and patients. What do we expect to learn from the maintenance cohorts? Really, the best maintenance strategy to employ is every other week dosing preferable. It seems like a lot of people are doing that now just out in the real world. Is monthly going to be the better strategy, and if so, what dose? We had only three monthly doses and one every other week dose in the prior study.

Brian Lian
President and CEO at Viking Therapeutics

We thought to better inform the cohorts that would go into the extension of VANQUISH, and there will be more than one dosing arm in the extension studies for maintenance in VANQUISH. It just made sense to expand the subQ cohorts and then defer the oral, since we weren't as time sensitive on the oral, to a separate part of the study.

Annabel Samimy
Annabel Samimy
Managing Director and Senior Analyst at Stifel

Okay. Got it. Just to clarify, you will have a very defined set of cohorts in that extension study drawing from this data, the phase I data.

Brian Lian
President and CEO at Viking Therapeutics

Oh, sure. Yeah, definitely. It'll be multiple maintenance cohorts there they'll be drawn from these data. Yes.

Annabel Samimy
Annabel Samimy
Managing Director and Senior Analyst at Stifel

Okay. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Annabel.

Operator

Thank you. We have the next question from the line of Biren Amin from Piper Sandler. Please go ahead.

Biren Amin
Biren Amin
Managing Director and Senior Research Analyst at Piper Sandler

Yeah. Hi, guys. Thanks for taking my question. Brian, I guess just on the VANQUISH extension, when will the maintenance doses be introduced for the subQ? Will that be at week 78 or week 84? How long will you be evaluating those subQ doses? I guess just a follow-on question. You know, for the VANQUISH dose cohorts, in the treatment phase of 7.5 mg and 12.5 mg weekly, how do you think about the transition of those patients to maintenance doses, given the maintenance trial is evaluating 15 mg weekly and higher in that 19-week induction period?

Brian Lian
President and CEO at Viking Therapeutics

Well, for the first question, we'll transition people at 78 weeks. It won't be a sort of a washout or anything like that out to 84. We plan to run the extension for 52 weeks. As far as the transition from 17.5 mg to whatever the, you know, maintenance dose might be, if you were to go from 17.5 mg to a higher 22.5 mg dose or something like that, there could be some incremental adverse events. That's not really what you see after a prolonged exposure like this, but those would all be things that, you know, we'll find out during the trial.

Biren Amin
Biren Amin
Managing Director and Senior Research Analyst at Piper Sandler

Great. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Biren.

Operator

Thank you. We have the next question from the line of Jay Olson from Oppenheimer. Please go ahead.

Jay Olson
Jay Olson
Managing Director and Senior Analyst at Oppenheimer

Hey. Congrats on all the progress, and thanks for taking the questions. Just to follow up on some of the factors that informed your decision to initiate the phase III oral study in the Q4, did you want to see the results of the phase I maintenance study in the Q3 before starting the phase III oral study in the Q4, or were there other factors involved? We also had a question on VK3019. Can you just talk about your plans for the phase I amylin program, or are you thinking about induction, maintenance, combination? I guess what's kind of on the table there for your amylin program. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Jay. For the oral study, no, we weren't planning to wait for the data. They're just independent factors. The maintenance data and the initiation of the oral studies, they were not related. With the VK3019 molecule, the first study will be, you know, before you think about combos and that sort of thing, first you want to understand the compound's basic properties. The first two studies will be a SAD study and then a MAD study. We are initiating combo talks with the VK2735 compound. Longer term, I think that's a really promising area to look at.

Brian Lian
President and CEO at Viking Therapeutics

The initial studies will just be single agent. It'd be kind of the playbook we used for VK2735 with a SAD followed by a 28-day MAD. You know, nice opportunity with this mechanism to, you know, potentially target people who are, you know, little lower BMI, you know, 32 to 34, 35, or people who can't, maybe can't tolerate a GLP-1 and wanna try something different. Both are, you know, very significant opportunities for the amylin program.

Jay Olson
Jay Olson
Managing Director and Senior Analyst at Oppenheimer

Great. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Jay.

Operator

Thank you. We have the next question from the line of Andy Hsieh from William Blair. Please go ahead.

Andy Hsieh
Andy Hsieh
Partner and Biotechnology Analyst at William Blair

Yeah, thanks for taking our question. Just for the extension portion of the VANQUISH study, I'm curious about maybe the patient's ability to select, just given the open label nature of this study. Do you allow patients to maybe down titrate if they're at a higher, you know, monthly dose or up titrate if they actually see, like a weight regain? Just maybe, you know, from a practical, you know, protocol related standpoint.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Andy. A great question. It's not really an open label study. People, you know, if you were on placebo, you will be randomized to a active agent, but you don't know which dose level you'll be at. We're not gonna, I think, discuss many design details otherwise until we actually start the study. You can imagine some people staying on their current therapy and some people transitioning maybe to a maintenance regimen. Different groups of people might be randomized to different cohorts. I think it's a very elegant and nice study design. We probably won't discuss too many details until we actually start it.

Andy Hsieh
Andy Hsieh
Partner and Biotechnology Analyst at William Blair

Got it. That's helpful. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Andy.

Operator

Thank you. We have the next question, the line of Roger Song from Jefferies. Please go ahead.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Great. Thanks for taking the question. Just to put a finer point on the VANQUISH, the extension regimen from the maintenance data you will report. I understand, you wanna expand every two weeks dosing. Is that fair to say you wanna pick one for monthly, one for every two weeks? How much delta among those dosing regimen, you will pick multiple within those two frequencies?

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Roger. Yeah. I think more generally, we wanna select the most effective arms and doses. Not wedded to a certain number of every other week or a certain number of monthlies, just whatever seems to be the most effective. We would look at, you know, multiple arms to come forward, and those would be based on whatever seems to look best in this initial, you know, 102 maintenance study.

Operator

Would that be all, Mr. Roger?

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Yeah, that's it. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Roger.

Operator

We have the next question on the line of William Wood from B. Riley Securities. Please go ahead.

William Wood
William Wood
Biotech Equity Research Analyst at B. Riley Securities

Hi. Thanks for taking our questions, and very nice progress you've been making. Two from us, one up front and then a follow-up. I'm just curious, in terms of your maintenance trial with the additions of the new subQ and then also sounds like the new additions of the oral, should we expect any delay in timing throughout the Q3, maybe from the beginning to the end? And/or should we expect sort of multiple data cuts throughout the Q3, in terms of, you know, whether it's at the 19-week and then the final maintenance, or we'll get the subQ first and then the oral? Maybe just if you could clarify on that and then I have a follow-up.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, William. It'll probably be two data releases, one for the subQ cohorts and then subsequently for the oral cohorts. The subQ will be in the Q3. We don't anticipate there being a substantial difference in the timing for the data to be available. Maybe a little bit, but not nothing, you know, significant.

William Wood
William Wood
Biotech Equity Research Analyst at B. Riley Securities

Right. Thank you. That's very helpful. Then on your VK3019, you've mentioned in the past that asset has shown better efficacy or potentially weight loss than your 27309, 27305, at least preclinically. I was curious if you could provide some of those comparative parameters of the two drugs, maybe Cmax, Tmax or half-life or even weight loss, understanding it all be preclinical and how this might have compared to, you know, tirzepatide or even peer amylins, if you've done any of those studies. Just sort of trying to get a better understanding of what stood out on this particular asset, that decided for you to bring it to the clinic. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, William. Unfortunately, I don't carry a lot of those data around in my head. There's too much other junk up there. It was very potent on the receptors. Very good PK profile that would be amenable to weekly dosing, we think, and that marries up nicely with the VK2735 PK profile. When we looked at data in rodents, it seemed to be, you know, better than cagrilintide. When we looked in obese monkeys, it seemed to provide better weight loss than VK2735. I don't have those numbers off the top of my head. These are just general comments.

William Wood
William Wood
Biotech Equity Research Analyst at B. Riley Securities

Great. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, William.

Operator

Thank you. We have the next question on the line of Hardik Parikh from JPMorgan. Please go ahead.

Hardik Parikh
Hardik Parikh
Analyst at JPMorgan

Hey, thank you very much for the updates today. Just a couple questions on the oral program. Just one is, I know in the past you've talked about, you're working on reducing the number of tablets you'd have to take at a dose. I was wondering if you have any updates there on where you are in that progress. Just a high-level question on, you know, you mentioned the launch of another oral peptide. What are your takeaways from that launch in terms of just what it says about the overall market and then the role of oral peptides in general? Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Hardik. We would want to have no more than two tablets as the higher dose option. Lower doses would be one tablet. In the phase II trial, everybody took four tablets, and the feedback we received was that's just people weren't real satisfied with that. No more than two tablets. You know, we generally don't comment too much about competitive dynamics, but I think the launch of the current oral peptide has been very robust and it supports, you know, this real, I think, high interest level in the oral modality.

Brian Lian
President and CEO at Viking Therapeutics

Interestingly, it's represented more of a market expansion than any sort of a cannibalization of the injectable market. It's been, I think a very impressive launch. Neil Aubuchon is our Chief Commercial Officer. He's here as well. Neil, do you have any additional color on that?

Neil Aubuchon
Neil Aubuchon
Chief Commercial Officer at Viking Therapeutics

Yeah, Brian, I think you characterized it well. Hi, Hardik. This is Neil here. Yeah, I think what we're seeing is this is growing the market, so it just goes to show that there's, you know, significant opportunities still. It's too early to comment on the, on the latest launch. I think it's just several weeks in, so I, you know, we wouldn't comment on it anyway, but it's awfully early. It's gonna be quite competitive dynamic between these two companies, as you would expect. The only thing I would also just remind you is that, you know, both the orals on the market are GLP-1s, where ours is gonna be a dual agonist oral. We expect to have the first dual agonist oral on the market, and I don't know if that's fully appreciated by folks in the ecosystem.

Neil Aubuchon
Neil Aubuchon
Chief Commercial Officer at Viking Therapeutics

We're pretty excited about the opportunity for our oral.

Hardik Parikh
Hardik Parikh
Analyst at JPMorgan

Great. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Hardik.

Operator

Thank you. We have our next question on the line of Yale Jen from Laidlaw & Company. Please go ahead.

Yale Jen
Yale Jen
Managing Director and Biotechnology Analyst at Laidlaw

Good afternoon. Thanks for taking the question. In terms of the VANQUISH expansion studies, would that also include both VANQUISH-1 and VANQUISH-2 in terms of the type 2 diabetes patients? As well as if you will incorporate some maintenance regimen into those in that study, would that also include the type 2 diabetes patients as well?

Brian Lian
President and CEO at Viking Therapeutics

Yes, it will. Yes.

Yale Jen
Yale Jen
Managing Director and Biotechnology Analyst at Laidlaw

Okay, great. That's very helpful, and thanks.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Yale.

Operator

Thank you. As we're nearing the conclusion of today's call, our final question will come from Jeet Mukherjee from BTIG. Please go ahead.

Analyst at BTIG

Hey, this is Blake on for Jeet. Thanks for taking the question. In regards to the subq maintenance data coming in the Q3, what does good look like to you guys, and are you comfortable reporting a modest regain? If so, is there a bar to standard that qualifies as weight retention? Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Blake. It's a good question. You know, I guess the way we look at it is best case scenario is you see a continuation of weight loss when you transition to the maintenance regimen. It's just the slope might change a little. I think our base case is, which is a great outcome, is just the real maintenance, you know. Less than really a few percent either way, up or down. The worst case would be you see a sharp rebound. You know, those are kind of the general scenarios that we're looking at. I think flatlining or relatively flat after the transition would be a really great outcome for us.

Operator

Would that be all, Jeet?

Analyst at BTIG

Yep. Thank you.

Operator

Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks.

Operator

This concludes our question answer session. I will hand it on the conference back over to Stephanie Diaz for any closing remarks.

Stephanie Diaz
Stephanie Diaz
Head of Investor Relations at Viking Therapeutics

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a good afternoon.

Operator

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

Executives
    • Neil Aubuchon
      Neil Aubuchon
      Chief Commercial Officer
    • Stephanie Diaz
      Stephanie Diaz
      Head of Investor Relations
Analysts
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