Viking Therapeutics at Jefferies Conference: Promising Weight Loss Drug

On Thursday, 05 June 2025, Viking Therapeutics (NASDAQ:VKTX) presented at the Jefferies Global Healthcare Conference 2025, focusing on its metabolic disease programs. CEO Brian Lian highlighted both the promising outcomes and challenges ahead, particularly for their lead drug candidate, VK2735. While the company’s financial position is robust, strategic partnerships are sought for broader market reach.

Key Takeaways

• Viking’s VK2735 showed up to 14.7% mean weight loss in a Phase 2 study.
• Phase 3 trials for VK2735 will commence this month in obese patients and those with type 2 diabetes.
• Viking ended Q1 with $850 million in cash, supporting ongoing and future studies.
• A long-term supply agreement with Cordon Pharma ensures ample API availability.
• The company is open to partnerships for commercialization in the obesity market.

Financial Results

• Cash Position:

- Viking ended the first quarter with $850 million in cash.

- This amount is deemed sufficient to fund both the registration and oral programs.

• Supply Agreement:

- Viking will make $150 million in milestone-based payments to Cordon Pharma from 2025 to 2028.

- The agreement supports a potential $10 billion annual opportunity.

Operational Updates

• VK2735 (Subcutaneous):

- Phase 3 trials set to start in June 2025, targeting obese patients and those with type 2 diabetes.

- A monthly PK study planned for Q3 2024 will explore transitioning from weekly to monthly dosing.

• VK2735 (Oral):

- An ongoing Phase 2 "Venture Oral" study with data expected later this year.

• Amylin Agonist:

- IND filing is planned for later this year.

• Manufacturing:

- A long-term supply agreement with Cordon Pharma ensures a multi-ton annual supply of API.

Future Outlook

• VK2735 (Subcutaneous):

- Details on Phase 3 trials to be announced soon, with a focus on dosing and duration.

- A PK study in Q3 2024 will assess monthly dosing feasibility.

• VK2735 (Oral):

- Future steps hinge on Phase 2 data, with potential for a maintenance study.

• Partnership Opportunities:

- Viking is interested in partnerships to expand market reach for its obesity program.

Q&A Highlights

• Maintenance Trial Design:

- The study will determine optimal monthly dosing for VK2735, transitioning from high weekly doses.

• Oral Dose Selection:

- Final decisions will depend on Phase 2 oral data outcomes.

• Manufacturing Costs:

- Subcutaneous formulation offers high margins, while oral margins are expected to improve with lower doses.

• Partnering:

- Viking remains open to partnerships, noting high interest from larger pharma companies.

Readers are encouraged to refer to the full transcript for a detailed account of Viking Therapeutics’ presentation and strategic plans.

Full transcript - Jefferies Global Healthcare Conference 2025:

Roger Song, Senior Analyst, Jefferies: Alright. Welcome, everyone, to Jefferies twenty twenty five Global Healthcare Conference. My name is Roger Song, one of the senior analysts cover SimiCAP Biotech in The US. It is my pleasure to introduce our next printing company, Viking Therapeutics CEO, Brian Lian. So he will do a corporate presentation.

And if you have some time for q and a toward the end, we’ll do that. Welcome, Lian.

Brian Lian, CEO, Viking Therapeutics: Great. Thanks, Roger. And thanks to Jeffries for the invitation. We’ve got a great schedule so really appreciate the opportunity to participate. I’ll make some forward statements today.

I would refer everyone hearing this presentation to refer to the Securities and Exchange Commission website for the most current information on Viking Therapeutics. I’ll walk through the story today. So we’re focused on developing novel therapeutics for metabolic and endocrine diseases. We’ll spend most of today talking about the metabolic disease programs, primarily our VK2735 program, which is a dual agonist of the GLP-one and GIP receptor. It’s completed a phase two study that successfully demonstrated weight loss at thirteen weeks and now we’re planning to move into phase three later this month.

We have an oral formulation of the same molecule that in phase one demonstrated proof of concept and we’re currently in a phase two study with that formulation today. And then finally we have an amylin agonist that’s a little earlier. We plan to file an IND with this program later this year. We have some additional programs focused on thyroid receptor agonism. VK2809 was a thyroid beta agonist that was successfully taken through a phase 2b study.

We reported that last year. And VK0214, another thyroid receptor agonist that we took through a phase 1b study in X linked adrenoleukodystrophy and reported that last year. We’re not actively developing these today. We’re seeking partners for those programs. Just a graphical representation of the programs, VK2735, the subcutaneous formulation is moving into phase three later this month.

We will also start a phase one monthly PK study in the third quarter with that formulation. We have the oral tablet formulation in phase two today and then the amylin agonist planning to file an IND with that program by the end of the year. So we started working on these peptide hormone agonists back in 2019. We looked at first the GLP-one monoagonists and then we looked at the dual agonist with GLP-one and GIP, and then finally looked at the triples with the glucagon added on to the other two. And really thought that the polyagonist approach was sort of the forefront of where the field was moving.

And we prioritized GLPGIP because we couldn’t see in our animal studies any incremental benefit from adding glucagon. So that’s where we focused. VK 2,735 was the lead program. We have two follow ons that are IND ready today. And in phase one SADMAD study, it was successful in the sub q formulation.

We read that out in 2023. We read out an obesity phase two study in 2024 and we’re planning to move into phase three later this month. So with these programs, these compounds, they’re all pretty potent on both receptors. We see sub 500 nanomolar binding to the human GLP-one and GIP receptors. GIP has a little greater variability in our compounds.

This slide just shows some of the early in vivo data. This is from a fourteen day rodent study, and you can see all of the colored lines are the VK compounds. See typically 15 to 30 delta relative to placebo on body weight over fourteen days. So really potent efficacy. The PK profiles generally show half lives from two days to seven days plus in primates and pretty well behaved.

That graph on the lower right shows the plasma concentration for a program called VK2745 and you can see the very, very tight reproducible curve, so really well behaved PK profiles. VK two thousand seven thirty five was then taken into a phase one SADMAD study. These are just the highlights from the MAD portion of that study. This was a four week study, four weekly doses, multiple ascending dose study, and what you can see here is the dose response as dosing was increased after twenty eight days, right around 8% weight loss at the top dose. But reduction in body weight occurred in all of the dosed cohorts and significant at the statistically significant at the highest two cohorts.

And importantly, we don’t have the trajectories in this deck, but no evidence of a plateau after twenty eight days. When we look at the GI tolerability in this study, very encouraging. You expect to see some nausea and maybe a little bit of vomiting as well from the GLP-one activation. And we did see some of that. But overall, no real response signal.

You can see that highest dose looked pretty similar to the lowest dose. Most of the adverse events reported in this study were mild or moderate and there were no discontinuations in this study due to GI adverse events. So the takeaways from the phase one study were we saw an encouraging early profile. All these subjects had a BMI of at least 30, so it was a reasonably representative population for what we’d end up targeting. We see dose dependent improvement in weight loss of up to nearly 8% from baseline after four doses.

We saw durability not in this deck, but when we had an assessment of body weight three weeks after the last dose, we saw pretty good maintenance of the weight loss effect. Looking at other markers, plasma lipids and liver fat indicate that additional metabolic effects were likely to be beneficial. Saw a really nice reduction in liver fat. PK data suggest really good exposures from weekly dosing, and finally, the safety and tolerability were also very promising with most of the AEs mild to moderate. Following that study, we designed a phase two study.

We called it the venture study and this targeted obese subjects with a BMI of at least thirty or a BMI of twenty seven plus one comorbidity, a weight related comorbidity. We looked at four doses, two and a half, five, ten, and fifteen milligrams with the higher doses, five, ten, and fifteen, we titrated up every three weeks. Primary endpoint was change in body weight after thirteen weekly doses. So we read these data out early last year and this shows the reduction in body weight that was observed after thirteen weeks. We saw a nice dose response from around 9% from baseline up to approximately 15% from baseline.

Nice dose response. When we look at the trajectories here, really nice trajectory, progressive across the entire study. Starting at week one and every subsequent week, was a statistically significant difference between the dosing arms and the placebo arm. And again, nice dose dependency. When you look at the curves, no evidence of plateaued just yet, so it suggests that longer dosing windows should provide an increase in weight reduction.

This is a slide that shows a subset of people who volunteered for more intensive PK And when we look at this subset of people, so you can see the ends aren’t, you know, they’re 35 in each arm, so we got about half of the people who volunteered to participate in the PK portion of the study. But what we see here is weight change at week twelve in the blue and week sixteen in the gold. So it’s four weeks after the last dose. And if you look across all the cohorts, you see that most of the weight loss was maintained for four weeks following the last dose. And overall, about 94% across all doses was maintained at week sixteen and over 80% if you look another three weeks out of week nineteen.

So really, again, speaks to that durability of effect, which was very encouraging. And we think that suggests that a monthly regimen should be feasible. We looked at the shift in diabetes status at week thirteen. So people in this study couldn’t have diabetes at entry, but when we look at the proportion that were pre diabetic at baseline, We did see a fair number who were pre diabetic. And then at week thirteen, we assessed the number who had shifted to a normal glycemic status, so from non pre diabetic to normal glycemic.

And we see a rapid shift to normal glycemic status, which suggests a promising effect on plasma glucose, which may suggest an improvement in diabetes status if you actually have diabetes. This slide shows the discontinuation rates across the arms. Pretty well balanced, discontinuing treatment early and discontinuing study early. If you look at the combined versus the placebo, we don’t necessarily see a difference. You do see a little bit of an uptick as you dose up in VK2735 dose, but that is primarily due to GI related adverse events.

Majority of these treatment emergent adverse events were mild or moderate. There was one SAE, a person had dehydration, that was deemed probably drug related. Looking more closely at GI tolerability, this is an important assessment that people look at with the GLP-one class. We can see that you do see an uptick in nausea as you come up and dose, you would expect. Mostly mild to moderate.

Similarly, a slight increase in vomiting as you dose up, but also primarily mild to moderate. But nothing really out of the ordinary or different from what you would expect with something that targets the the incretin axis. This is an interesting set of two graphs. The graph both of the graphs are showing the sort of a histogram of a time course of GI adverse events. So the green is constipation, aqua is diarrhea, blue is nausea, and gold is vomiting.

So if you focus on that left hand graph, you can see early on in week one you have the highest rate of nausea and then it pretty much drops through the study. The asterisks indicate where an uptitration occurred. So in the left hand graph, people started at two point five mgs and then uptitrated to five mgs at that week four time point. And so you can see that nausea picked up again and then dropped through the remainder of the treatment window. Big difference between the left graph and the right graph is that the right graph shows the fifteen milligram cohort and the fifteen milligram cohort started at five milligrams.

So you started at double the dose of the left hand graph and you can see that leads to an increase in nausea rate and vomiting rate. So it tells you you don’t want to start at five milligrams. So when you go across then, you look at week ten, you do see another uptick in nausea, and that was the only week where we actually went way up in the dose. So we went from ten to fifteen. Normally, went in two and a half mg increments, but at week ten we went to ten to fifteen and you can see them in uptick in nausea as well.

So the takeaway here, for us anyway, is that you really want to start low and just go slow through the titration window. So the study takeaways for us after the thirteen week study, we saw up to 14.7% mean weight loss after thirteen weeks of weekly treatment. Really promising tolerability. More than ninety percent of the treatment emergent adverse events were mild to moderate. The majority of the GI related adverse events occur early and then resolve with continued dosing.

Really interesting durability of weight loss. More than ninety percent of the efficacy retained four weeks after the last dose. And we think that that durability and PK profile would suggest that a monthly regimen is feasible. So the next steps with the SubQ formulation, we did have an end of phase two meeting with the FDA in December that was really helpful in planning the phase three trials. We are planning to initiate two studies this month.

One is in patients with obesity, so that’s a BMI of 30 or above or twenty seven plus one comorbidity, and another in patients with obesity and type two diabetes. They’ll include extensions to assess longer term efficacy following the completion of the studies and again, we expect to start those later this month. And we’ll announce the details, doses, duration, all that size later this month. Another study that we’re really interested in getting going, and we’ll start it in the third quarter here, is to evaluate the PK when you transition somebody from a weekly dose to a monthly regimen. So this study will rapidly titrate people up using a weekly cadence and then transition them different cohorts to a range of monthly doses.

And this is really intended to look at where plasma levels kind of land when you reduce that dose frequency. We’ll also take some additional cohorts and transition them to low dose oral daily regimen. So we’ll get a good feel for is the monthly feasible, is a low dose oral feasible and look at PK and how body weight changes over time. Again, starting that later this quarter. So in parallel with the sub q formulation, we’ve been developing a tablet formulation.

We’ve taken this through a phase one MAD study and this was actually a placebo controlled extension of the sub q MAD study. What the boxes here on the bottom show are the doses that were explored. So the lower left box shows two point five mgs per day for four weeks. After every cohort, we had a dose level review team that reviewed the safety and tolerability data and then recommended to proceed or not. And so, going through that process, it’s kind of a linear process, but we went up to a dose of one hundred milligrams, and that dose started at eighty per week and went to one hundred for three weeks.

And then we had an experimental dose, that far right box on the lower right. This was a cohort where we dosed people up to eighty milligrams and then brought them to an eighty milligrams every other day for the final two weeks of the study. And that was just kind of a quick and dirty, what is a low dose maintenance, what would that look like? This slide shows the overall weight change after twenty eight days of daily dosing, and we did see a dose dependent reduction in body weight across the dosing cohorts. Top dose, about 7% placebo adjusted.

You see a little bit of a downtick in weight at sixty milligrams. We think that was just a kind of a small numbers effect. But overall, we were satisfied with the body weight change after only twenty eight days of dosing. This is, we think, a really interesting slide. It shows that dotted line is placed at day twenty eight.

So this is showing the trajectory of weight loss over fifty seven days. And so the red line is that one hundred milligram cohort and you can see moving down to about 8.2% weight loss from baseline after twenty eight days. But what was interesting to us is when we look over fifty seven days, the following four weeks, we see a pretty good maintenance of effect there. The one hundred mg is the most obvious where it’s just pretty much of a flat line. It’s eight point three percent at fifty seven days, eight point two at twenty eight days.

But the lower doses, the sixty and the eighty, also showed a pretty slow rebound. So we were happy to see that. We think it probably reflects the extended half life. The half life’s about eight days. So further evidence that we think maintenance here might be achieved with less frequent dosing or with a lower dose once you’ve reached some target weight level.

When we look at the GI tolerability from this study, really encouraged by the overall GI side effect profile. Looking at nausea, I mean, really mild signal, all of the cases, no moderate or no severe. You do see a little bit of an increase with dose, as you’d expect. Very little vomiting, and otherwise a pretty benign overall GI tolerability profile. So the study takeaways from the twenty eight day phase one, we saw up to 8.2% reduction in body weight after twenty eight days of daily dosing.

Most of the arms were progressive, which would suggest that longer treatment should lead to a further increase in weight loss. Majority effect was maintained four weeks after the final oral dose was administered. Excellent tolerability through the one hundred milligram dose with ninety nine percent of the adverse events characterized as mild to moderate. We did see the mechanism expected nausea at the higher doses. We think that’s probably addressable with an extended titration window.

And then that exploratory transition, I don’t have that slide in here, but when you went from eighty milligrams daily to eighty milligrams every other day, we saw pretty much parallel response lines between the transition cohort with the regular eighty milligram cohort. So that suggests low dose maybe is feasible when you transition. Once you get some inertia, you transition to a lower dose. Following this study, we designed and initiated a phase two study we call the venture oral study. Just like the sub q study, it’s thirteen weeks, and that is ongoing.

It’s outlined here. This is seven arms or yeah, seven arm study, forty per arm, with six dosing arms ranging from fifteen milligrams up to one hundred and twenty milligrams. And if you see that second to the bottom cohort, that’s another one of these exploratory cohorts where we titrate people up to ninety milligrams and keep them there for four weeks and then titrate them down to thirty milligrams per day and keep them there for five weeks. And another quick and dirty look at this maintenance type of approach. So with this study, we announced initiation in January, announced the completion of enrollment in the first quarter, later in the March, and we expect to have data available sometime in the second half.

And what are the next steps with the program? We don’t know. We have to look at the phase two data and make that decision. But ideally, we’d parallel the sub q path if it’s possible. And we will also, as I mentioned, maintenance study that we’re looking at transitioning from high dose weekly to monthly injection, we’ll also have oral cohorts in that study also to look at maintenance effects.

A lot of discussion about supply chain and, you know, API demands in peptide based drugs. So we announced earlier this year a long term supply agreement with Cordon Pharma, and this will guarantee us access to a multi ton annual supply of API, which is expandable at our option. We have access to additional fill and finish capabilities of up to a hundred million annual units of vial and syringe product, as well as a hundred million units of auto injector product and also expandable at our option. Finally, we we also, in part of this agreement, we had have access to over a billion annual tablet capacity available to us. Economics, we will pay Gordon a hundred and 50,000,000 in milestone based payments from 2025 to 2028 and that’s pretty evenly spread across those three years.

Those payments are fully credited against future orders. So, you know, you think of it as not really out of pocket, so to speak, since we get discounts on future orders. And we think this initial agreement a lot of ways to slice up how the product would be divided, but we think the initial agreement is sufficient to support a $10,000,000,000 annual opportunity. Looking quickly at our capital structure, we ended the first quarter with 850,000,000 in cash. We think that is sufficient to get us through the registration program and very far along in the oral program as well.

So fortunate to have a really good runway today. And this is the last slide. So again, the company’s focused on metabolic disease programs. The program that we’re most focused on today is our VK2735 dual agonist for obesity, GLP-one, GLP agonist in phase two, which showed an attractive efficacy signal in weight loss, and we’re planning to initiate phase three later this month. The oral formulation of the same compound demonstrated promising proof of concept in phase one, and we’re now in a phase

They’ll read out later this year. And then we have an amylin program. We didn’t talk about it in this presentation, but another really interesting program we’re filing an IND for later this year. So that’s the story. Thanks very much for your attention.

Excellent.

Roger Song, Senior Analyst, Jefferies: Brian, can you give me a couple Sure. All right, awesome. So I think this maintenance trial is very, very interesting given that you have two compounds with different and then dosing regimen. So can you give us a little bit color around what’s the, you know, potential design for the weekly dosing starting and then what’s the monthly dosing? And then you also say it’s a low dose oral, so what’s the low dose?

Yeah,

Brian Lian, CEO, Viking Therapeutics: so the idea is really to see what is the right monthly dose and what does the PK show as well? What’s the drug exposure through the course of the following thirty days after each dose? So we’ll titrate people as quickly as we can up to some high weekly dose and then transition them to a range of monthlies. And so we don’t know on the monthly cadence, do you have to dose higher? Can you dose the same?

Can you dose lower? So we’ll explore some different dose levels on the monthly frequency and really look at PK and on efficacy. It’s a short study to look at efficacy, but we would look at any change in the slope of the curve. And hopefully, if you’re losing weight, it wouldn’t change positive. At worst, it would be flat because maintenance would really be just to prevent weight regain.

With the oral, same story. We’ll transition some cohorts to a low daily oral dose and really monitor PK plasma levels of the drug and also look at if there’s any change in the slope of the weight trajectory. And also a range of the low dose oral? Yeah, we’ll have more than one arm in that oral portion, yep.

Roger Song, Senior Analyst, Jefferies: And then you say it’s a short study and then how long the duration we should think about, maybe the entire the weekly and then the maintenance?

Brian Lian, CEO, Viking Therapeutics: Yeah, hard to project. We haven’t started. We don’t know the enrollment timelines. We’re thinking of probably around a three month maintenance one, so three monthly doses would probably be the duration there.

Roger Song, Senior Analyst, Jefferies: So the date you will start a trial 3Q, probably next year you will start

Brian Lian, CEO, Viking Therapeutics: Hopefully we’d have those results in 2026, yes, yeah.

Roger Song, Senior Analyst, Jefferies: And given you will have the oral portion and then you will have the data from a phase two oral, do you need to see the phase two data before you will start the maintenance therapy?

Brian Lian, CEO, Viking Therapeutics: The phase two from the Oral. Venture oral. You know, I originally was thinking that way, but our clinical team said no, no, we’re not going to transition for a little while. So we can go ahead and start without necessarily having all the data on hand, yeah.

Roger Song, Senior Analyst, Jefferies: Got it, yeah. You can start a weekly titration.

Brian Lian, CEO, Viking Therapeutics: Yeah, because it’s going take a while to get up to that top dose, yeah. But

Roger Song, Senior Analyst, Jefferies: you probably, you’re not going to be finalized the oral dose until you see the phase two eventually.

Brian Lian, CEO, Viking Therapeutics: Right, right. We have kind of a range we’re guessing in, but we’ll be confirming when we see the data, yeah.

Roger Song, Senior Analyst, Jefferies: Very good. And then in terms of the manufacturing, that’s another key topics from investors. Just on the injectable side, think you already laid out pretty well. And then on the oral side, what would you consider as attractive kind of manufacturing costs for the

Brian Lian, CEO, Viking Therapeutics: oral

Roger Song, Senior Analyst, Jefferies: peptide, you know, particularly considering the maintenance therapy for the oral use?

Brian Lian, CEO, Viking Therapeutics: Oh yeah, well on the sub q we’ve got really, really great margins. Oral margins are lower because you’re using a lot more drug. But you know, in the lower dose daily maintenance, think those really attractive margins still. As you get to, you know, higher doses on a daily basis, the margins are not as good. So we would probably seek some of the lower doses for further development.

We’ll see what the study shows. One thing that’s interesting is we have seen some reduction in price points through the, you know, course of the last eighteen months or so on peptide production.

Roger Song, Senior Analyst, Jefferies: Okay, very good. And then in terms of the partnering discussion, I think you are basically prepared to launch prepared to do the Phase three for the injectable by itself and then you’re well capitalized to do that. But also we understand that obesity is the massive market, but there for the commercialization. How what’s the current thinking about that? Also, maybe the second part of the question is that, how do you see the level of interest from the strategic change over time?

Now, we see

Brian Lian, CEO, Viking Therapeutics: many deals every other week and then how you think about that playing to your future partner? Yeah, yeah, we’ve always said that, you know, we think a larger party would be a good idea to get involved with to help expand the availability of the program, but we’re also prepared to move forward in the absence So we want to be flexible there, but we’re certainly receptive to inbound interest. What was the second part? Level of interest?

Oh, oh yeah, yeah, I think, I mean everybody sees the same earnings reports. Mean people are pretty aware of the market size and I you know I think what we’ve seen in the past I don’t know twelve to twenty four months is a continued high level of enthusiasm across the board. Probably more companies kind of deciding to get involved than there were, I don’t know, eighteen months ago. But the, I can’t speak for pharma, it seems like there’s a lot of how to best approach it. Is it a new mechanism?

Is it an existing mechanism that’s de risked? Is it you know, is there a geography that’s most important? Things like that. So a lot of kind of still assessing the situation. But the interest is I think maintained or higher than it was I’d say eighteen months ago.

Roger Song, Senior Analyst, Jefferies: Got it. And then we definitely see more large pharma. We don’t know they have the interest before they are starting to do the deal. I think eighteen months maybe a little bit too long for OBT spaces or how you think about the more recent months and then how the interest level is actually changing if at all?

Brian Lian, CEO, Viking Therapeutics: I think it’s just maintained pretty high and you see the BD activity that’s ongoing. So I think, you know, it’s the largest market in pharmaceutical history. So most companies are trying to find the best angle to enter.

Roger Song, Senior Analyst, Jefferies: Excellent. Thank you Brian for taking a couple questions and thank you everyone listening. Thanks Roger.

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