Q1 2025 Viking Therapeutics Inc Earnings Call
Play mode.
Following managements prepared remarks, we will hold a Q&A session.
To ask a question at that time. Please press the star key followed by one on your Touchtone phone.
For more information, visit www.C crowds.org
If anyone has difficulty hearing the conference. Please press star zero for operator assistance.
As a reminder, this conference call is being recorded today April 23 2025.
Welcome to the Viking Territputics, First Quarter 2025 Financial Results, Conference Call. At this time, all participants are in another Sonomely mode.
Speaker Change: I would now like to turn the conference over to Viking's manager of Investor Relations Stephanie Diaz.
Speaker Change: Please go ahead Stephanie.
Following Management's Prepared remarks, we will hold a Q&A for the Viking therapeutics for the first quarter of the 29.5 financial results. Our confidence calls by 1 on your touchstone 4. At this time, all participants are in a one-hand remoteie hearing the conference. Following Management's Prepared remarks, we will hold a Q&A session instance. To ask a question at that time, please press the star key followed by 1 on your touchstone 4. If anyone has to call the hearing the conference over, please press star 0 for our operator.
Hello, and thank you 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 23, 2025, we will contain forward looking statements under the safe Harbor per.
Speaker Change: Visions of the U S Securities Litigation Reform Act of 1095, including statements about Vikings 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 statements made today I encourage you to review all of the Companys filings with the Securities and Exchange Commission concerning these and other matters I will now turn the call over to Brian Lian for his initial comments.
Brian Lian: Thank you for participating in today's call. We'll be joining me today as Ryan Lian, and by mistake, Viking's president and CEO and Greg Zante is like a woman, Admiral.
Speaker Change: Before we begin, I'd like to caution that a comment made during this conference regarding today's April and September 3, 2020, lines and miles will contain four of the statements of the state part of the division of the US secured by the National Reform Act to different materially and adversely, including statements about Viking's expectations regarding as a development activity for timelines and miles, four of the statements, four of the statement of the subject to risks and the company that could cause a casual result to different materially and adversely. And reported results, you should not think
Brian Lian: Thanks, Stephanie and good afternoon to everyone listening in by phone or on the webcast.
Brian Lian: Today, We will review our financial results for the first quarter ended March 31, 2025, and provide an update on recent progress with our development programs and operations and.
Brian Lian: In the first quarter of 2025 Viking continued to build upon the strong momentum achieved in 2024 in.
In the past year, we announced positive data from four separate clinical programs, including our VK. Two 735 subcutaneous program for obesity are VK. Two 735 oral tablet program for obesity are VK, two eight or nine program for the treatment of mash in fibrosis.
in the city as an indication of a major formage commission.
Speaker Change: 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 for the Securities Exchange Commission concerning these and other matters. I will now turn the call over to Brian Lian for some initial comments. Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today we'll review our financial results for the first quarter ended March 31st, 2025.
Brian Lian: And our <unk> program for X linked Adrenoleukodystrophy.
Brian Lian: By any measure 2024 was our most productive year to date and this positive momentum has continued into 2025.
Brian Lian: During the first quarter the company made great progress towards the initiation of phase III trials for our subcutaneous VK two 735 program and we expect to commence these studies later this quarter.
Speaker Change: We have provided an update on recent progress with our development programs and operations including our VK-27. In the first quarter of 2025 program, I can continue to build upon our strong momentum to achieve in 2024. In the past year, our VK-27 is now the data from four separate financial programs including our VK-745-7010 program for obesity.
The company also announced the initiation of a phase II trial evaluating the tablet formulation of VK two 735 in subjects with obesity.
Later in the first quarter, we announced the completion of enrollment in this trial.
Speaker Change: R.V.K. 2035, Oral, Tablet Program, Oral, B.S.R. Most Productive Year, R.V.K. 2809 Program, for the treatment of mash and fibrosis in 255.
Brian Lian: We believe this study's rapid enrollment reflects continued enthusiasm for obesity program and we look forward to announcing the results of the study later this year.
Speaker Change: and our VK-O-214 program for active company greenery, this progress toward the initiate by any measure in 2020 was our motion for the active year today, and this positive momentum has continued into 2025.
Brian Lian: Also during the first quarter Viking entered into a long term large scale manufacturing agreement to support the future commercialization of VK, two 735 million obesity.
Speaker Change: During the first quarter, the initial company made great progress toward the initiation of phase 3 trial for our sub-tri-tainless VK2735 program. Later, and we expect to commence the WNW, the completion of the real wilderness trial.
Brian Lian: The agreement provides for both API and fill and finish activities, which we believe will be sufficient to support a potential multibillion dollar annual product opportunity.
Brian Lian: During the quarter. The company also made progress with its newest program evaluating a series of internally developed agonist of the amylin receptor, which have demonstrated improvements in body weight and metabolic profile and in vivo models.
Speaker Change: The company also announced the initiation of A2 products and devaluating the capital formulation of DK2735 for the results of the study later in the first quarter. We announced the completion of enrollment in this. Viking entered into a long term. We believe this study's rapid enrollment reflects continued enthusiasm for our BC program. We look forward to announcing the results of the study later in the future. Also during the first quarter, Viking entered into a long term, large scale manufacturing.
I'll have additional comments on our operations and development activities. Following a review of our first quarter financial results.
Brian Lian: For that I'll turn the call over to Greg Zante, Viking's, Chief Financial Officer.
Thanks, Brian and.
In conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-Q filings with the Securities and Exchange Commission, which we expect to file later this month.
Speaker Change: Duller, to support the future commercialization of VK-2-2-2-2-5. You know, these company also made progress. The agreement provides for our API and the villain finish active, which we believe will be sufficient to support a potential multi-billion dollar annual pro-medical profile in vivo model. We're in the quarter.
I'll now go over our results for the first quarter.
Research and development expenses were $41 4 million for the three months ended March 31, 2025, compared to $24 1 million for the same period in 2024.
Speaker Change: The company also made progress with the Common Program, evaluating the theories that the internally developed tag in a review of the hammer-on receptor and answer results, which had demonstrated improvements in body weight and metabolic profile in Vivo models.
The increase was primarily due to increased expenses related to manufacturing for our drug candidates clinical studies stock based compensation and salaries and benefits, partially offset by decreased expenses related to preclinical studies.
Brian Lian: Thanks, Brian . I'll have additional comment on our operations and development activities. Following a review of our first quarter financial results. For that, I'll turn the call over to Greg Zante, Viking Chief Financial Officer. I'll now go over our results for the first time. Thanks, Brian .
General and administrative expenses were $14 1 million for the three months ended March 31, 2025 compared to $10 million for the same period in 2024.
Greg Zante: In conjunction with my comment, I would like to recommend that participants refer to Biking Reform's end-of-March 30, 2040, for the Exchange Commission, which would be $4.1 million for the same period in 2020. I'll now go over our results for the first quarter. Research and development expenses were $41.4 million for the three-month end of March 31, 2025, compared to $24.1 million for the same period in 2024. The increase was primarily due to increased expenses related to manufacturing for a drug candidate.
The increase was primarily due to increased expenses related to legal and patent services stock based compensation and insurance, partially offset by decreased expenses related to salaries and benefits.
Brian Lian: For the three months ended March 31, 2025, Viking reported a net loss of $45 6 million or <unk> 41 per share compared to a net loss of $27 4 million or <unk> 26 per share in the corresponding period of 2024.
Greg Zante: 18.1 million clinical studies and the Marksock faith compensation five and salaries and benefit 10 million for the partially upset by decreased expenses related to pre-recredits, primarily due to increased expense, general and administrative expenses for the 14.1 million of the three months and the March 31st, 2025, by compared to 10 million for the same period in 2024.
Brian Lian: The increase in net loss for the three months ended March 31, 2025 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously.
Brian Lian: Partially offset by increased interest income compared to the same period in 2024.
Greg Zante: The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and insurance, or $40,000, especially by decreased expenses.
Turning to the balance sheet.
At March 31, 2025, Viking held cash cash equivalents and short term investments of $852 million compared to $903 million as of December 31, 2024.
Greg Zante: The three-month end of March 31, 2025, Viking reported a net loss of $0.456 million, or $0.41 per share, compared to a net loss of $0.274 million, or $0.26 per share in the corresponding period of 2024.
Brian Lian: This concludes my financial review and I'll now turn the call back over to Brian.
Brian Lian: Thanks, Greg I'll now provide an overview of our pipeline programs and outline next steps for each starting with our lead obesity program VK two to 705.
Greg Zante: The increase in that loss for the three months ended at March 31st, 2005.
Greg Zante: was primarily due to the increase in research and development in March 31st to the end-genre and administrative development that was previously published and shortly upset by increased interest income compared to the same period in 2024.
Brian Lian: VK two 735 is a dual agonist of the glucagon like peptide one or <unk>, one receptor and the glucose dependent insulin the trophic polypeptide or <unk> receptor.
Number 31. Turning to the balance sheet.
The companys prior phase one trial for the subcutaneous formulation of VK, two 735 demonstrated promising safety Tolerability and pharmacokinetics.
Speaker Change: At March 31st, 2025, Viking Health Cash, all the cash of the provolence and short-term investments of 852 million. I'll now provide an overview of our pipeline program and outline the next step 24 each, starting with our lead. At least, he proves my financial review.
And treated subjects demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau.
Brian Lian: Following the successful completion of phase one studies, we initiated a phase Iia study called Debenture study.
Brian Lian: D.K.275 is a dual eye. I'll now provide an overview of our pipeline programs and outline next steps for each starting with our lead obesity program D.K.275
Brian Lian: This study evaluated 13 weeks of dosing with VK, two 735 in subjects with obesity.
As we reported last year the venture study successfully achieved its primary and secondary endpoints.
Subjects, receiving VK, two 735 achieved statistically significant reductions in mean body weight from baseline ranging up to 14, 7%.
Brian Lian: The study also showed VK, two 735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment emergent adverse events characterized as mild or moderate.
Adverse events generally occurred early in the course of treatment and were primarily related to the expected Gi effects, resulting from activation of the <unk> receptor.
These results as well as additional results from follow up visits conducted at four and seven weeks. After completion of dosing were highlighted in our presentation at obesity week 2020 for the annual meeting of the obesity Society.
Brian Lian: The follow up data showed that subjects, receiving VK two 735 maintain the majority of their weight loss through the seven week follow up visit.
The study also showed VK, two 735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment emergent adverse events characterized as mild or moderate.
Brian Lian: This included the $2 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 which was administered.
Adverse events generally occurred early in the course of treatment and were primarily related to the expected Gi effects, resulting from activation of the <unk> receptor.
Brian Lian: In a subset of participants and evaluation of plasma levels of VK. Two 735 at various time points. Following completion of the 13 week dosing period was conducted.
These results as well as additional results from follow up visits conducted at four and seven weeks. After completion of dosing were highlighted in our presentation at obesity week 2020 for the annual meeting of the obesity Society.
Brian Lian: We believe the pharmacokinetic results support the potential for once monthly dosing in the maintenance setting and the company is planning to further evaluate our monthly dosing regimen later this year.
Following the successful conclusion of the phase II venture study and after receiving feedback from a type C meeting with the FDA last summer.
The follow up data showed that subjects receiving VK two 735 maintained the majority of their weight loss through the seven week follow up visit.
Brian Lian: We made the decision to advance VK, two 735 into phase III development for obesity.
This included the $2 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 which was administered.
Brian Lian: To this end we requested an end of phase II meeting with the agency, which took place in the fourth quarter of last year.
Brian Lian: The feedback from this meeting was extremely helpful. In informing our overall development plan and in particular, our phase III plan for the program.
In a subset of participants and evaluation of plasma levels of VK. Two 735 at various time points. Following completion of the 13 week dosing period was conducted.
Brian Lian: Since the end of phase II meeting our team has been working diligently to prepare for the initiation of the phase III trials and we remain on track to initiate these studies later this quarter.
We believe the pharmacokinetic results support the potential for once monthly dosing in the maintenance setting and the company is planning to further evaluate our monthly dosing regimen later this year.
In parallel with the advancement of the subcutaneous formulation of VK two to 705 Viking is also evaluating an oral tablet formulation.
Following the successful conclusion of the phase II venture study and after receiving feedback from a type C meeting with the FDA last summer we made the decision to advanced VK, two 735 into phase III development for obesity.
Brian Lian: The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved.
To this end we requested an end of phase II meeting with the agency, which took place in the fourth quarter of last year.
Brian Lian: We believe a key differentiating advantage of our obesity program is that we have both a tablet formulation and a subcutaneous formulation that utilize the same molecule.
The feedback from this meeting was extremely helpful. In informing our overall development plan and in particular, our phase III plan for the program.
Since the end of phase II meeting our team has been working diligently to prepare for the initiation of the phase III trials and we remain on track to initiate these studies later this quarter.
Brian Lian: These formulations create the potential to transition patients from one formulation to another with the possibility of reducing the risk of unexpected safety or tolerability challenges.
Brian Lian: We believe this represents a potentially valuable option for those with obesity and their clinicians.
In parallel with the advancement of the subcutaneous formulation of VK. Two 705 Viking is also evaluating an oral tablet formulation.
Brian Lian: Viking's phase phase one study for the oral formulation was a randomized double blind placebo controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter square.
The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved.
Brian Lian: The primary objective of the study was to evaluate the safety and Tolerability of VK. Two 735 administered as a tablet once daily for 28 days with secondary and exploratory objectives evaluating the pharmacokinetics of oral VK, two 735, as well as changes in body weight and other metrics.
Brian Lian: As with the venture Phase III study the oral phase one trial successfully achieved its objectives. The data from this study showed that cohorts receiving VK two 730, <unk> demonstrated dose dependent reductions in mean body weight from baseline ranging up to eight 2% after 28 days.
Brian Lian: Persistent weight loss effects of up to eight 3% from baseline were observed at follow up visits through day 57, four weeks after the last dose was administered.
Brian Lian: Based on our preliminary evaluation of weight loss trajectories. The company believes that continued treatment beyond 28 days may provide further reductions in body weight.
Brian Lian: The oral formulation of VK. Two 735 also demonstrated encouraging safety and Tolerability through 28 days of once daily dosing at doses up to and including 100 milligrams.
Brian Lian: The majority of the observed treatment emergent adverse events were mild or moderate with most reported as mild.
Similarly, all observed gastrointestinal adverse events were reported as mild or moderate with the majority reported as mild.
Brian Lian: The results from this study were presented at the obesity week Conference last November.
Brian Lian: Following the successful conclusion of the phase one study.
Brian Lian: In January of this year Viking announced the initiation of a phase II trial called debenture oral dosing trial in subjects with obesity.
Brian Lian: The venture oral trial is a randomized double blind placebo controlled multicenter study.
Brian Lian: Designed to evaluate the safety Tolerability pharmacokinetics and weight loss efficacy of VK $2 75 doses in oral tablet once daily for 13 weeks.
Brian Lian: In March we announced completion of enrollment for this trial and the trial has successfully met its enrollment objective enrolling approximately 280 adults who are obese or adults who are overweight with at least one weight related comorbidity condition.
Brian Lian: Enrolled subjects had been evenly randomized to one of six dosing arms or placebo.
Brian Lian: The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment.
Brian Lian: <unk> and exploratory endpoints will evaluate a range of additional safety and efficacy measures.
Brian Lian: We believe the rapid enrollment of this trial speaks to the continued high level of interest and enthusiasm for new weight loss options, among both clinicians and their patients.
Brian Lian: We expect to report data from this study in the second half of 2025.
Brian Lian: Beyond our accretive program last year at the annual meeting of the American Diabetes Association, we announced a new program evaluating a series of novel agonist of the amylin receptor.
Brian Lian: We believe activation of the amylin receptor represents an important additional mechanism related to appetite and weight management.
Brian Lian: Progress with our Amylin program is continuing and we expect to file an IND for the program later this year.
Brian Lian: Moving to additional corporate milestones in the first quarter, we announced that we had entered into an important supply agreement related to the VK two 735 program.
This agreement provides for large scale API manufacturing as well as fill and finish capacity for both the injectable and oral formulations of VK two 735.
Brian Lian: With this important partnership in place Viking believes it will have access to our commercial supply of API auto injectors violence, syringe kits and oral tablets sufficient to support a potential multibillion dollar annual product opportunity.
Brian Lian: With respect to the company's financial position as Greg indicated in his comments Viking continues to maintain a strong balance sheet with more than $850 million in cash as of the end of the first quarter.
Brian Lian: This provides us with the runway to complete our planned phase III trials for VK for the VK, two 735 obesity program as well as to aggressively pursue the clinical development of our additional programs.
Brian Lian: And other corporate matters like many others, we are awaiting clarity on how the potential introduction of tariffs might impact our current and future operations.
Brian Lian: At this point, we expect minimal near term impact across our development programs.
Brian Lian: As to the longer term impact on potential commercial activities, it's too early for us to assess what the tariff environment, maybe at some point in the future.
Brian Lian: We look forward to these important negotiations being completed as soon as practicable.
Brian Lian: In conclusion, we are excited to report that the tremendous progress Viking made in 2024 is carried over into the first quarter of 2025.
Brian Lian: Following the Companys most productive year to date <unk> made great progress preparing for the initiation of phase III trials for subcutaneous VK 275, which are on track to begin in the second quarter.
Brian Lian: In the first quarter, we also announced both the initiation and completion of enrollment in our phase III venture oral dosing trial.
Brian Lian: We believe that this study's rapid enrollment reflects a continued enthusiasm for our program and we look forward to reporting data from this study in the second half of the year.
Brian Lian: With respect to our new Amlin agonist program, we continue to make progress towards IND filing, which we expect to submit later this year.
Brian Lian: Also during the first quarter were happy to sign a broad multi year manufacturing agreement to support the future commercialization of VK two 705.
Brian Lian: This comprehensive agreement provides large scale annual supply of API as well as fill and finish capacity for both the injectable and oral product forms.
Brian Lian: And finally, our strong balance sheet allows us to continue to advance each of these each of these programs effectively and aggressively including through phase III trials for VK, two 705 obesity program and other key inflection points.
Brian Lian: This concludes our prepared comments for today, thanks, very much for joining us and we'll now open the call for questions operator.
Speaker Change: We will now begin the question and answer session.
Speaker Change: To ask a question you May press Star then one on your telephone keypad.
Speaker Change: If youre using a speakerphone please pick up your handset before pressing the keys.
Speaker Change: If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.
Speaker Change: Due to our limited time today as well as a large queue for the Q&A.
Speaker Change: Thankfully request that everyone limit themselves to a single primary question and one follow up question only.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
Joon Lee: The first question comes from Joon Lee with.
<unk> Securities. Please go ahead.
Speaker Change: Hi, congrats on the quarter and thanks for taking the questions. This is awesome run on for Jim just a couple from us.
Speaker Change: In the phase III venture oil Gal Cohen include the four week follow up data or will the top line only include data with <unk>.
Speaker Change: And then as a follow up.
Speaker Change: Do you plan on introducing the auto injected into the phase III and with the plans and timing for inpatient study. Thank you.
Operator: This time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by 1 on your touchtone phone.
Speaker Change: Yes, thanks for the questions yet for the.
Speaker Change: The topline data from the oral study.
Speaker Change: We have historically reported the top line data when they're available.
Speaker Change: So I would expect that.
Operator: If anyone has difficulty hearing the conference, please press star 0 for operator assistance.
Speaker Change: That's likely before the.
Speaker Change: The four week follow up data are available, but keep in mind, though there'll be top line data.
Operator: As a reminder, this conference call is being recorded today, April 23rd, 2025.
Speaker Change: With the introduction of the auto injector that would be as soon as we can introduce it I would say that's most likely.
Stephanie Diaz: I would now like to turn the conference over to Vikings Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.
Speaker Change: Early next year.
Speaker Change: And we will be doing a bridging study with the violin syringe comparing to the auto injector in the interim.
Stephanie Diaz: Hello, and thank you for participating in today's call. Joining me today is Brian Lian, Viking's president and CEO, and Greg Zante, Viking CF.
Speaker Change: Thank you Dan.
Speaker Change: Thanks.
Stephanie Diaz: Before we begin, I'd like to caution that comments made during this conference call today, April 23rd, 2025, will contain forward-looking statements under the Safe Harbor provisions of the U.S. 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.
The topline data from the oral study.
Speaker Change: The next question comes from Mike <unk> with Morgan Stanley. Please go ahead.
We've historically reported the top line data when they're available and.
Mike: Good afternoon, and thanks for taking the question.
I would expect that.
Mike: Just one on the phase III venture oral data that you plan to share in the second half of this year just curious if there's a specific level of weight loss youre looking to achieve there and how do you think about that level of weight loss at the lower doses versus the higher doses.
Likely before the.
Four week follow up data are available, but keep in mind, there will be top line data.
Mike: Yes, Thanks, Mike.
Mike: Hard to project its a larger study than the phase one, but it's obviously dosing longer as well.
Stephanie Diaz: 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.
Mike: I think if we can show.
Stephanie Diaz: I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.
Mike: 8% or so which is what we showed at the high dose last time for you to show that.
Brian Lian: I'll now turn the call over to Brian Lian for his initial comments. Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today we'll review our financial results for the first quarter ended March 31st, 2025 and provide an update on recent progress with our development programs and operations. In the first quarter of 2025, Viking continued to build upon the strong momentum achieved in 2024. In the past year, we announced positive data from four separate clinical programs, including our VK2735 Subcutaneous Program for Obesity, our VK2735 Oral Tablet Program for Obesity, our VK2809 Program for the Treatment of MASH and Fibrosis.
After 12 weeks I think we'd have a competitive profile.
Mike: But.
Mike: It really hard to know.
Maybe just one on the phase two venture oral data that you plan to share in the second half of this year. Just curious if there's a specific level of weight loss youre looking to achieve there and how do you think about that level of weight loss at the lower doses versus the higher doses.
Mike: Prior to <unk>.
Mike: On blinding the data.
Mike: And with the lower doses.
Mike: Yes.
Mike: It just really hard to prognosticate on what the efficacy might be hopefully over time as you see continued accumulation youll see those lower doses perform well but.
Yeah. Thanks, Mike Yeah hard to project its a larger study than the phase one, but it's obviously dosing longer as well. So I think if we can show.
Mike: It's hard to tell.
Mike: Yes.
Mike: Great. Thank you.
Mike: Thanks, Mike.
8% or so which is what we showed at the high dose last time for you to show that.
Speaker Change: The next question comes from Ryan Deschner with Raymond James. Please go ahead.
After 12 weeks I think we'd have a competitive profile.
Brian Lian: and our VK-0214 program for X-linked adrenoleukodystrophy. By any measure, 2024 was our most productive year to date, and this positive momentum has continued into 2025. During the first quarter, the company made great progress toward the initiation of phase three trials for our subcutaneous VK2735 program, and we expect to commence these studies later this quarter. The company also announced the initiation of a Phase II trial evaluating the tablet formulation of VK2735 in subjects with obesity. Later in the first quarter, we announced the completion of enrollment in this trial. We believe this study's rapid enrollment reflects continued enthusiasm for our obesity program, and we look forward to announcing the results of the study later this year.
Ryan Deschner: Hi, Thanks for the question.
But.
Really hard to know.
Ryan Deschner: Wondering hey, it's really looking at the potential positioning.
Prior to.
On blinding the data.
Speaker Change: The Doctor candidate if you were to evaluate its potential as a co formulation with 20 735, how early in the clinical progression of this candidate would you do that.
And with the lower doses.
Yes.
It just really hard to prognosticate on what the efficacy might be hopefully over time as you see continued accumulation youll see those lower doses perform well but.
Speaker Change: Yeah. Thanks, Brian So the first study there would be the typical sad Mad study like we did with the 2735 program.
Right.
It's hard to RTL.
Speaker Change: We would like to evaluate.
Great. Thank you.
Speaker Change: Combination.
Speaker Change: Regimen as soon as we can but that probably wouldnt happen.
Thanks, Mike.
The next question comes from Ryan Deschner with Raymond James. Please go ahead.
Speaker Change: Until next year, some time, we'd like to understand the single agent profile first.
Hi, Thanks for the question.
Wondering how you're probably looking at the potential positioning.
Brian Lian: Also during the first quarter, Viking entered into a long-term, large-scale manufacturing agreement to support the future commercialization of VK2735 in OBC. The agreement provides for both API and fill and finish activities, which we believe will be sufficient to support a potential multi-billion dollar annual product opportunity. During the quarter, the company also made progress with its newest program, evaluating a series of internally developed agonists of the amylin receptor, which have demonstrated improvements in body weight and metabolic profile in in vivo models.
The Doctor candidate if you were to evaluate its potential as a co formulation with 20 735, how early in the clinical progression of this candidate would you do that.
Speaker Change: Thank you.
Jay Olson: The next question from Jay Olson with Oppenheimer. Please go ahead.
Jay Olson: Oh, Hey, congrats on the progress and thanks.
Yeah. Thanks, Brian So the first study there would be the typical SaaS Mad study like we did with the 2735 program, we would like to evaluate.
Speaker Change: Thanks for taking the questions are you planning to test.
Speaker Change: Oral VK two 735 in other indications besides obesity like type two diabetes and then I have a follow up question if I could.
Combination.
Regimen as soon as we can but that probably wouldnt happen.
Speaker Change: Yes, Thanks, Jay well the phase III program will consist of.
Until next year, some time, we'd like to understand the single agent profile first.
Brian Lian: I'll have additional comments on our operations and development activities following a review of our first quarter financial results.
Speaker Change: One study in obese subjects and one study in obese diabetics and so.
Greg Zante: For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer. Thanks, Brian.
Yeah.
Speaker Change: In that second study and those will be type two patients and we will be looking at.
Thank you.
The next question from Jay Olson with Oppenheimer. Please go ahead.
Greg Zante: 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 later this month. I'll now go over our results for the first quarter. Research and development expenses were $41.4 million for the three months ended March 31, 2025, compared to $24.1 million for the same period in 2024. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, stock-based compensation, and salaries and benefits, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $14.1 million for the three months ended March 31, 2025, compared to $10 million for the same period in 2024.
Speaker Change: Weight change and glycemic control, but that will give us a lot of really useful data we think.
Yeah.
Oh, Hey, congrats on the progress and thanks for taking the questions are you planning to test oral VK two 735 in other indications besides obesity like type two diabetes and then I had a follow up question if I could.
Speaker Change: Okay, great. Thank you for that and then.
Speaker Change: Can you share any comments on recent obesity deals, especially for novel targets small molecules assets coming out of China, maybe comment on the overall level of strategic.
Yes, Thanks, Jay well the.
The phase III program will consist of.
Speaker Change: Strategic interest in the obesity space.
One study.
Speaker Change: Yes, it's hard for us to comment on.
In obese subjects and one study in obese diabetics and so in that second study.
Speaker Change: Any BD type discussions, but I'd say there is there continues to be high interest in the space.
Speaker Change: <unk>.
Those will be type two patients and we will be looking at.
Speaker Change: I think we have a very attractive portfolio, but.
Weight change and glycemic control, but that will give us a lot of really useful data we think.
Speaker Change: Yes.
Speaker Change: Hard to give a lot of color on further discussions there.
Oh, Okay, great. Thank you for that and then.
Greg Zante: The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and insurance. partially upset by decreased expenses related to salaries and benefits. For the three months ended March 31st, 2025, Viking reported a net loss of $45.6 million or $0.41 per share, compared to a net loss of $27.4 million or $0.26 per share in the corresponding period of 2024. The increase in net loss for the three months ended March 31st, 2025, 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 2024.
Speaker Change: Okay fair enough thanks for taking the questions.
Could you share any comments on recent obesity deals, especially for novel targets small molecules and assets coming out of China, and maybe comment on the overall level of <unk>.
Jay Olson: Thanks Jay.
Speaker Change: The next question comes from <unk> Parikh with Jpmorgan. Please go ahead.
Speaker Change: Hey, Brian Thanks for the update today I think in the past you've mentioned that you were sorting through some logistics before kind of initiating the phase III for 27 to 35 I was just wondering if you can kind of provide us an update there.
Strategic interest in the obesity space.
Yes, it's hard for us to comment on.
Any BD type discussions, but I would say there is there continues to be high interest in the space.
Speaker Change: And then are the remaining two dues are they more regulatory in nature like with FDA or are they more internal operational items and then the second part is is.
I think we have a.
Very attractive portfolio, but.
Speaker Change: Is there any chance that the initiation of the phase III fleet into <unk>. Thank you.
Yes.
Hard to give a lot of color on further discussions there.
Speaker Change: Thanks, Ali well right now and we plan to initiate the study in the second quarter.
Okay fair enough thanks for taking the questions.
Speaker Change: And Theres no reason to think we can't do that as far as the.
Thanks Jay.
The next question comes from <unk> Parikh with J P. Morgan. Please go ahead.
Greg Zante: Turning to the balance sheet, at March 31, 2025, Viking held cash, cash equivalents, and short-term investments of $852 million. compared to 903 million as of December 31st, 2024.
Speaker Change: What is happening in preparation for the study primarily its logistical.
Hey, Brian Thanks for the update today I think in the past you've mentioned that you were sorting through some logistics before kind of initiating the phase III 427, and 35 I was wondering if you could kind of provide us an update there.
Speaker Change: The suppliers ready getting the.
Speaker Change: Sites up and ready.
Speaker Change: A lot of different doses, there will be a titrate titration scheme in the study so having the.
Brian Lian: This concludes my financial review, and I'll now turn the call back over to Brian. Thanks, Greg.
And then are the remaining two dues or are they more regulatory in nature with FDA or are they more internal operational items and then the second part is is there any chance that the initiation of the phase III bleeds into <unk>. Thank you.
Speaker Change: Proper number of doses labeled.
Brian Lian: I'll now provide an overview of our pipeline programs and outline next steps for each, starting 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. The company's prior Phase I trial for the subcutaneous formulation of VK2735 demonstrated promising safety, tolerability, and pharmacokinetics, and treated subjects demonstrated up to approximately 8% weight loss from baseline after 28 days, with no signs of plateau. Following the successful completion of Phase I studies, we initiated a Phase IIa study called the Venture Study. This study evaluated 13 weeks of dosing with VK2735 in subjects with obesity.
Speaker Change: Manufactured and prepared for administration.
Speaker Change: It's a big lift it's a lot of people lot lot larger overall program then the phase Iia study.
Thanks, Ali well right now and we plan to initiate the study in the second quarter.
Speaker Change: Okay. Thank you.
Speaker Change: Thanks Hari.
Speaker Change: The next question comes from <unk> <unk> with B Riley <unk> Securities. Please go ahead.
And Theres no reason to think we can't do that as far as the.
What what is happening in preparation for the study primarily its logistical.
Speaker Change: Yes. Good afternoon, thanks for taking our questions and congrats on the progress Brian on multiple fronts. So on the manufacturing side with guidance.
Getting the suppliers ready getting the.
Sites up and ready.
Speaker Change: Are you able to comment on what sort of Cogs youre targeting in a steady state and maybe differences between peptide in oral and any metrics should we shouldn't be looking at Aps.
A lot of different doses, there will be a tighter titration scheme in the study so having the.
Proper number of doses labeled.
Speaker Change: Or something like that and then I have a quick follow up.
Manufactured and prepared for administration, it's just a it's.
Speaker Change: No I think I think it's hard to.
It's a big lift it's a lot of people lot lot larger overall program then the phase Iia study.
Talk about Cogs is are those are pretty tightly.
Okay. Thank you.
Speaker Change: This tightly held information but.
Thanks Harlan.
Brian Lian: As we reported last year, the Venture Study successfully achieved its primary and secondary end. Subjects receiving the K2735 achieve statistically significant reductions in mean body weight from baseline, ranging up to 14.7%. The 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. 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-1 receptor. These results, as well as additional results from follow-up visits conducted at four and seven weeks after completion of dosing, were highlighted in a presentation at Obesity Week 2024, the annual meeting of the Obesity Society.
Speaker Change: I'd say, we will have <unk>.
The next question comes from my end, Montana with B Riley Securities. Please go ahead.
Speaker Change: Margins that are consistent with.
Speaker Change: Other peptide products nothing unusual about what the margins might be.
Hi, yes. Good afternoon, thanks for taking our questions and congrats on the progress Brian on multiple fronts.
Speaker Change: The scale of the manufacturing agreement as large.
Manufacturing side with Garden pharma are you able to comment on what sort of caused youre targeting in a steady state and maybe differences between peptide in oral and any metrics should we shouldn't be looking at Aps.
Speaker Change: And.
Speaker Change: There are tiers to pricing as scale increases so we think thats very favorable to us but.
Or something like that and then I have a quick follow up.
Speaker Change: Unable to give a lot of granularity on that specific price points.
No I think I think it's hard to.
Speaker Change: Okay, and nothing between the peptide versus Oro.
Talk about Cogs is a those are pretty tightly.
Brian Lian: And then on the oral study quickly Brian.
This tightly held information, but I would say we will have.
Brian Lian: Of the objective for this tiny Mig maintain enzyme that you have and follow up to the 90 Meg.
Margins that are consistent with.
Brian Lian: Cohort Youre doing and maybe just help us understand how to think about that.
Other peptide products nothing unusual about what the margins might be.
Brian Lian: Sure.
Brian Lian: The follow-up data showed that subjects receiving VK2735 maintained the majority of their weight loss through the seven-week follow-up this This included the 2.5 mg 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. In a subset of participants, an evaluation of plasma levels of VK2735 at various time points following completion of the 13-week dosing period was conducted. We believe the pharmacokinetic results support the potential for once-monthly dosing in the maintenance setting, and the company is planning to further evaluate a monthly dosing regimen later this year.
Speaker Change: Data versus a regular <unk> 19, Meg that youre doing versus the higher dose one Meg.
The scale of the manufacturing agreement as large.
Uh huh.
The there are tears to pricing as scale increases so we think thats very favorable to us but.
Speaker Change: We're just trying to understand why youre doing it pretty Mcmahon Dana thanks for taking the question.
Speaker Change: Yes, sure, we'll see that step down so you titrate up to 90, and then I think people stay there for.
Unable to give a lot of granularity on that specific price points.
Speaker Change: Four weeks or so and then and then it comes down to 30 for the for the five remaining weeks.
Okay and nothing between the Bev Diversely Lauro.
Brian: And on the oral study quickly Brian.
Speaker Change: Thats really to understand.
Brian: Minus of the objective for this tiny Mig maintain enzyme that you have and follow up to the 90 Meg.
Speaker Change: If you can come down from a high dose to a lower dose in and prevent weight gain.
Brian Lian: Cohort Youre doing and maybe just help us understand how to think about that.
Speaker Change: And sort of just in a quick and dirty test on low dose maintenance, we think it should.
Speaker Change: Data versus a regular 19, Meg that youre doing versus the higher dose one <unk> Meg.
Speaker Change: Provides sufficient drug to prevent weight gain when we've always thought the oral would be well utilized in a low dose maintenance setting once you've lost weight down to some target range you can transition potentially to a monthly injection or two a.
Brian Lian: Following the successful conclusion of the Phase 2 Venture Study, and after receiving feedback from a Type C meeting with the FDA last summer, we made the decision to advance VK2735 into Phase 3 development for obesity. To this end, we requested an end of phase two meeting with the agency, which took place in the fourth quarter of last year. The feedback from this meeting was extremely helpful in informing our overall development plan, and in particular, our Phase 3 plan for the program. Since the end of Phase 2 meeting, our team has been working diligently to prepare for the initiation of the Phase 3 trials, and we remain on track to initiate these studies later this quarter.
Speaker Change: We're just trying to understand why youre doing the tiny Mcmahon dance. Thanks for taking my question.
Speaker Change: Yes sure.
Speaker Change: That step down so you titrate up to 90 and then.
Speaker Change: I think people stay there for.
Speaker Change: Four weeks or so and then and then come down to 30 for the for the five remaining weeks.
Speaker Change: Daily low dose. So this is just one way to.
Speaker Change: Understand that possibility a little bit better.
Speaker Change: That's really to understand.
Speaker Change: Even better.
Speaker Change: If you can come down from a high dose to a lower dose in and prevent weight gain.
Speaker Change: Weight loss continues which is a possibility, but I think our goal here is to understand if.
Speaker Change: And sort of just in a quick and dirty test on a low dose maintenance, we think it should.
Speaker Change: At least we prevent week regain.
Speaker Change: Got it thank you.
Speaker Change: Provide sufficient drug to prevent weight gain and we've always thought the oral would be well utilized in a low dose maintenance setting once you've lost weighed down to some target range you can transition potentially to a monthly injection or two.
Brian Lian: In parallel with the advancement of the subcutaneous formulation of VK2735, Viking is also evaluating an oral-tablet formulation. The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved. We believe a key differentiating advantage of our obesity program is that we have both a tablet formulation and a subcutaneous formulation that utilize the same molecule. These formulations create the potential to transition patients from one formulation to another with the possibility of reducing the risk of unexpected safety or tolerability challenges.
Speaker Change: The next question comes from Annabel <unk> with Stifel. Please go ahead.
Annabel: Hi, Thanks for taking my question I appreciate it.
Speaker Change: Just as.
Speaker Change: As far as the phase III for the injectable do you have a better sense of how you might incorporate the question of durability. I think you mentioned youre going to look at it monthly.
Speaker Change: A daily low dose oral so this is just one way to.
Speaker Change: Later on in the year, but is it possible can be incorporated into the phase III trials.
Speaker Change: Understand that the possibility of a little bit better I mean.
Speaker Change: It would be even better weight loss continues which is a possibility, but I think our goal here is to understand if.
Speaker Change: And then for the auto injector, you also said youre going to be.
Speaker Change: Conducting a bridging study does auto injector need to be incorporated into the phase III study in any way.
Speaker Change: At least we prevent weight regain.
Speaker Change: Got it thank you.
Speaker Change: Thanks, Paul the auto injector will introduce the auto injector into the phase III, which is why we're doing.
Annabel: The next question comes from Annabel <unk> with Stifel. Please go ahead.
Brian Lian: We believe this represents a potentially valuable option for those with obesity and their clinicians. Viking's Phase I study for the oral formulation 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 VK2735 administered as a tablet once daily for 28 days, with secondary and exploratory objectives evaluating the pharmacokinetics of oral VK2735, as well as changes in body weight and other As with the Venture Phase 2 study, the Oral Phase 1 trial successfully achieved its objective.
Annabel: Hi, Thanks for taking my question I appreciate it.
Speaker Change: The comparative study from the.
Speaker Change: Just as far as the phase III for the injectable do you have a better sense of how you might incorporate the question of durability. I think you mentioned youre going to look at it monthly.
Speaker Change: <unk> to the auto injector. So that's the reason for that.
Speaker Change: That comparison study.
Speaker Change: As far as the.
Speaker Change: Monthly regimen first step there is.
Speaker Change: Later on in the year, but is it possible can be incorporated into the phase III trials.
Speaker Change: Do the initial study, which will involve a titration upward using the weekly regimen to some high dose level and then transition people onto the <unk>.
Speaker Change: And then for the auto injector you also said you were going to be.
Speaker Change: Ducting, a bridging study does auto injector it needs to be incorporated into the phase III study in any way.
Speaker Change: Monthly regimen.
Speaker Change: Whether or not we would introduce that.
Speaker Change: Into the Phase III program is TBD right now.
Speaker Change: Thanks, Paul.
Injector will introduce the auto injector into the phase III, which is why we're doing.
Speaker Change: Phase III protocols do not.
Brian Lian: The data from this study shows that cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 days. Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day 57, four weeks after the last dose was administered. Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond 28 days may provide further reductions in body weight. The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 milligrams. The majority of observed treatment emergent adverse events were mild or moderate, with most reported as mild.
Speaker Change: Incorporate that but if there were an extension study or something like that maybe that's a possibility to incorporate the monthly.
Speaker Change: The comparative study from the.
Speaker Change: <unk> to the auto injector. So that's the reason for.
Speaker Change: Got it.
Speaker Change: That comparison study.
Speaker Change: As a follow up with dosing for the oral if all of these doses are tolerable, we'd likely keep the doses or start to pare them down.
Speaker Change: As far as the.
Speaker Change: Monthly regimen first step there is.
Speaker Change: Do the initial study, which will involve a titration upward using the weekly regimen to some high dose level and then transition people onto the <unk>.
Speaker Change: As you move into phase III.
Speaker Change: Yes, I think we'll have to see what the data look like I think it's premature to pick doses now and we haven't seen any of the phase III data.
Speaker Change: Monthly regimen.
Speaker Change: Okay. Thank you.
Speaker Change: Or not we would introduce that.
Ed: Yes, Thanks Ed.
Speaker Change: Our next question comes from Roger song with Jefferies. Please go ahead.
Speaker Change: Into the Phase III program is TBD right now.
Speaker Change: <unk> III protocols do not.
Ed: Great.
Brian Lian: Incorporate that but if there were an extension study or something like that maybe that's a possibility to incorporate the monthly.
Roger Song: Thanks, Scott Thanks for taking my question and then with an update so regarding the phase III Q can you comment on the potential design of the phase III, how different or similar to other.
Brian Lian: Got it.
Brian Lian: As a follow up with dosing for the oral if all of these doses are tolerable, we likely keep the doses or start to pare them down.
Either.
Brian Lian: Similarly, all observed gastrointestinal adverse events were reported as mild or moderate with the majority reported as mild.
Roger Song: Other obesity trials have been conducted and then regarding the Amazon.
Greg Zante: As you move into phase III.
Roger Song: What is the potential target profile of <unk> <unk>.
Speaker Change: Yes, I think we'll have to see what the data look like I think it's premature to pick doses now and we haven't seen any of the phase II data.
Brian Lian: The results from this study were presented at the Obesity Week Conference last November.
Roger Song: Before the R&D, given we already see some preclinical data.
Brian Lian: Following the successful conclusion of the Phase I study, in January of this year, Viking announced the initiation of a Phase II trial called the Venture Oral Dosing Trial in subjects with obesity. The Venture Oral Trial is a randomized, double-blind, placebo-controlled, multi-center study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. In March, we announced completion of enrollment for this trial and that the trial had successfully met its enrollment objective, enrolling approximately 280 adults who are obese or adults who are overweight with at least one weight-related comorbid condition.
Roger Song: How much better do you want to.
Greg Zante: Okay. Thank you yes.
Roger Song: Thank you.
Ed: Yes, Thanks Ed.
Roger Song: Yes, Thanks Roger.
Speaker Change: Our next question comes from Roger song with Jefferies. Please go ahead.
Roger Song: The phase III trials.
Speaker Change: Those we'll announce all the details as we initiate the studies, but I would say they will they will conform to guidance.
Ed: Great.
Speaker Change: Scott Thanks for taking my question and then with an update.
Greg Zante: So regarding the phase III. The Q can you comment on the potential design of the phase III.
Roger Song: <unk>.
That is minimum of 4500 people across total across the two studies.
Speaker Change: Ill defined and similar to the other.
Speaker Change: One in obese subjects, one rovs diabetics.
Speaker Change: Other obesity trials have been conducted and then regarding the Amazon.
Speaker Change: And 52 weeks of post titration treatment.
Speaker Change: What is the potential target profile, you try to try to get before the R&D given we already see some preclinical data.
Speaker Change: As far as the doses and titration schemes things like that we will wait to start the studies before we provide.
Greg Zante: How much better do you want it.
Speaker Change: Any further color on those.
Greg Zante: Thank you.
Brian Lian: Enrolled subjects have been evenly randomized to one of six dosing arms or placebo. The primary end point of the study is the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We believe the rapid enrollment of this trial speaks to the continued high level of interest and enthusiasm for new weight loss options among both clinicians and their patients.
Speaker Change: With the Amylin program, we've done a lot of.
Greg Zante: Yes, thanks, Roger well with the <unk>.
Greg Zante: Phase III trials.
Speaker Change: Work with.
Greg Zante: Those we'll announce all the details as we initiate the studies, but I would say they will they will conform to guidance. So.
Speaker Change: A lot of different compounds looking at various <unk>.
Speaker Change: Combinations and formulation work.
Speaker Change: To understand the the best Amylin candidate to bring forward.
Greg Zante: That is minimum of 4500 people across total across the two studies.
Speaker Change: And that took <unk>.
Speaker Change: Wait a while but I think we have a really interesting compound.
Greg Zante: One in obese subjects one of these diabetics.
Speaker Change: We'll bring that into the clinic will be weekly long acting amylin, we'll bring them in the clinic hopefully by the end of the year.
Greg Zante: And 52 weeks of post titration treatment.
Brian Lian: We expect to report data from this study in the second half of 2020.
Greg Zante: As far as the doses.
Greg Zante: Titration schemes things like that we'll wait to start the studies before we provide any further color on those.
Speaker Change: Thank you.
Brian Lian: Beyond our Creighton program, last year at the annual meeting of the American Diabetes Association, we announced a new program evaluating a series of novel agonists of the amylin receptor. We believe activation of the amyloid receptor represents an important additional mechanism related to appetite and weight management. Progress with our AMLIN program is continuing, and we expect to file an IMD for the program later this year.
Roger Song: Thanks Roger.
Speaker Change: The next question comes from Andy Shay with William Blair. Please go ahead.
Greg Zante: With the Amylin program, we've done a lot of.
Speaker Change: Work with.
Speaker Change: A lot of different compounds looking at various.
Andy Shay: Thanks, Thanks for taking my questions and congratulations on the progress.
Speaker Change: Combinations and formulation work.
Speaker Change: Sure.
Steady that Youre contemplating I am curious about the design frameworks, you're considering so looking across some of the <unk>.
Speaker Change: To understand the the best Amylin candidate to bring forward.
Speaker Change: And that took.
Brian Lian: Quite a while but I think we have a really interesting compound. So we'll bring that into the clinic will be weekly long acting amylin, we'll bring them to the clinic hopefully by the end of the year.
Speaker Change: We see studies with the maintenance component.
Brian Lian: Moving to additional corporate milestones, in the first quarter, we announced that we had entered into an important supply agreement related to the VK2735 program. This agreement provides for large-scale API manufacturing, as well as fill-and-finish capacity for both the injectable and oral formulations of VK2735. With this important partnership in place, Viking believes it will have access to a commercial supply of API, auto-injectors, violin syringe kits, and oral tablets. to support a potential multi-billion dollar annual product opportunity.
Speaker Change: Unlike attain maintained with just appetite and ofer.
Speaker Change: <unk> six <unk>.
Speaker Change: None of them actually use the same compound transitioning from sub acute oral so so we're just curious what parameters would you like to explore such as logger or lower doses.
Brian Lian: Thank you.
Greg Zante: Thanks Roger.
Speaker Change: The next question comes from Andy Shay with William Blair. Please go ahead.
And do you need to reach some sort of plateauing before the transition.
Speaker Change: Thanks, Thanks for taking my questions and congratulations on the progress.
Speaker Change: For the maintenance study that Youre contemplating I'm curious about the design frameworks, you're considering so looking across some of the obesity studies with the maintenance component.
Andy Shay: Yes, yes, thanks Andy.
Speaker Change: At plateau on exposures are.
Brian Lian: With respect to the company's financial position, as Greg indicated in his comments, Viking continues to maintain a strong balance sheet with more than $850 million in cash as of the end of the first quarter. This provides us with the runway to complete our planned phase three trials for the VK2735 Obesity Program, as well as to aggressively pursue the clinical development of our additional program.
Andy Shay: Body weight, you're referring to.
Speaker Change: Oh body weight, so basically.
Speaker Change: Like attain maintained with just appetite and of a clip on.
Speaker Change: Okay, yes, thanks, Helane and body weight.
Just the maintenance phase of that part of the study.
Speaker Change: Try and recapture tight none none of them actually use the same compound transitioning from sub acute oral so so we're just curious what parameters would you like to explore such as lager.
Speaker Change: No no great Great question, Yes, no I don't think we'd want to wait for the plateau, because I don't know when that.
Speaker Change: It might happen it might happen quite a bit later.
Brian Lian: In other corporate matters, like many others, we are awaiting clarity on how the potential introduction of tariffs might impact our current and future operations. At this point, we expect minimal near-term impact across our development program. As to the longer-term impact on potential commercial activities, it's too early for us to assess what the tariff environment may be at some point in the future. We look forward to these important negotiations being completed as soon as practice allows.
Speaker Change: No.
We would we would like to.
Speaker Change: The lower doses.
Speaker Change: Do you need to reach some sort of plateauing before the transition.
Speaker Change: Be able to titrate up to some elevated dose and then explore.
Andy Shay: Yes, yes, thanks Andy.
Speaker Change: A less frequent regimen.
Speaker Change: At a variety of doses.
Speaker Change: Plateau on exposures or ore body weight, you're referring to.
Speaker Change: Then also look at transition too.
Andy Shay: Oh body weight, so basically.
Speaker Change: All right.
Speaker Change: I'm sorry.
Speaker Change: And then as well.
Speaker Change: We get we will get a lot of information from that from that study.
Andy Shay: And body weight.
Andy Shay: Just the maintenance phase of that.
Andy Shay: Part of the study.
Andy Shay: Yes, no no its a great great question, Yes, no I don't think we'd want to wait for the plateau, because I don't know when that.
Brian Lian: In conclusion, we are excited to report that the tremendous progress Viking made in 2024 has carried over into the first quarter of 2025. Following the company's most productive year to date, Viking made great progress preparing for the initiation of phase 3 trials for subcutaneous VK2735, which are on track to begin in the second. In the first quarter, we also announced both the initiation and completion of enrollment in our Phase II Venture Oral Dosing trial. We believe that this study's rapid enrollment reflects a continued enthusiasm for our program, and we look forward to reporting data from this study in the second half of the year.
Speaker Change: That's helpful.
Speaker Change: Maybe a commercial question I know this is.
Speaker Change: Maybe several years away, but with the success.
Andy Shay: It might happen that might happen quite a bit later.
Speaker Change: Slowly direct.
Andy Shay: No.
Speaker Change: And also the complexity associated contracting.
Andy Shay: We would we would like to.
Andy Shay: Be able to titrate up to some elevated dose and then explore.
Speaker Change: For rebates and discounts I'm curious.
Speaker Change: Direct to consumer model for the obesity market is already substantial.
Andy Shay: On a less frequent regimen.
Andy Shay: At a variety of doses.
Andy Shay: Then also look at the transition too.
Speaker Change: And.
Speaker Change: Sufficient for.
Andy Shay: All right.
It's kind of a standalone Viking two to take a look at it without going through all.
Andy Shay: And then as well.
Andy Shay: We will get a lot of information from that study.
Speaker Change: The complexity of nickel.
Brian Lian: With respect to our new amylin agonist program, we continue to make progress toward an IND filing, which we expect to submit later this year.
Speaker Change: Negotiation.
Speaker Change: Negotiation is that kind of stuff.
Andy Shay: That's helpful.
Andy Shay: Maybe a commercial question I know this is.
Speaker Change: Yeah, and it's a really great question.
Andy Shay: Maybe several years away, but with the success.
Brian Lian: Also, during the first quarter, we're happy to sign a broad, multi-year manufacturing agreement to support the future commercialization of VK-27. This comprehensive agreement provides large-scale, annual supply of API, as well as fill and finish capacities for both the injectable and oral products. And finally, our strong balance sheet allows us to continue to advance each of these programs effectively and aggressively, including through phase 3 trials for the DK2735 obesity program and other key inflections.
Speaker Change: I think in normal times, probably would be.
Speaker Change: Let me direct.
More challenging, but what we've seen with the.
Speaker Change: And also the complexity of fishery contracting.
Speaker Change: The introduction of these compound pharmacies and these other direct to consumer model.
Speaker Change: For rebates and discounts.
Speaker Change: I'm curious.
Speaker Change: You don't have any sales force that.
Speaker Change: Direct to consumer models for the obesity market is already substantial and sufficient.
Speaker Change: That is a viable channel.
Speaker Change: So youre right its a little early for us to make a decision like that but the.
Speaker Change: The viability of that sort of model.
Speaker Change: Sufficient for.
Speaker Change: For it's kind of a standalone Viking to to take a look at it without going through it all.
Speaker Change: <unk> is proven out and so it gives us optionality and it just opens different avenues to two.
Speaker Change: The complexity of those.
Stephanie Diaz: This concludes our prepared comments for today. Thanks very much for joining us, and we'll now open the call for questions.
Speaker Change: Negotiation.
Speaker Change: To market the product.
Speaker Change: Price negotiations and that kind of stuff.
Speaker Change: Sure.
Operator: Operator? We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad.
Speaker Change: Okay, great and what more if I can squeeze in.
Speaker Change: Yeah, and it's a really great question.
Speaker Change: I think in normal times, probably would be.
Speaker Change: Basically the learnings that you've gained from advancing VK, 2010, 35, including potentially longer half life flow T. Max oral formulation, how much of that can be applied to your amulet program.
Speaker Change: More challenging, but what we've seen with the <unk>.
Operator: If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. Due to our limited time today, as well as the large queue for the Q&A, we respectfully request that everyone limit themselves to a single primary question and one follow-up question only.
Speaker Change: The introduction of these compound pharmacies and these other direct to consumer models.
Speaker Change: I don't if you don't have any sales force that.
Speaker Change: That is a viable channel.
Speaker Change: So you're right. It's a little early for us to make a decision like that but the.
Speaker Change: Yes, it's a good question, we do think the <unk> probably are amenable to oral formulation.
Speaker Change: The viability of that sort of model.
Speaker Change: And.
Speaker Change: <unk> is proven now and so it gives us optionality and it just opens different avenues to two.
So thats I think thats really interesting.
Speaker Change: The.
Operator: At this time, we will pause momentarily to assemble our roster.
Speaker Change: Half lives, meaning each compound a little difference in.
Speaker Change: To market the product.
Speaker Change: Great and one more if I can squeeze in so.
Speaker Change: The ambulance obviously different peptide then the dual agonist so.
Joon Lee: The first question comes from Joon Lee with Truist Securities. Please go ahead. Hi, congrats on the quarter, and thanks for taking the questions.
So basically the.
Speaker Change: I don't know that you can.
Speaker Change: The learnings.
Speaker Change: That you gained from advancing BK, 27, 35, including potentially longer half life flow T. Max oral formulation, how much of that can be applied to your analog program.
Speaker Change: Translate a whole lot since the molecules are different we do think the PK profile as.
Asim Rana: This is Asim Rana on for June, just a couple from us. Is the Phase 2 Venture Oral Readout going to include the 4-week follow-up data, or will the Top Line Readout only include data with 13 weeks of dosing? And then as a follow-up, when do you plan on introducing the auto-injector into the Phase 3, and what are the plans and timing for bridging the study?
Speaker Change: As supportive of a weekly regimen, but.
Speaker Change: Other than that.
Speaker Change: I guess.
Speaker Change: Yes, it's a good question and we do think the <unk> probably are amenable to oral formulation.
Speaker Change: Since it's a different molecules hard to translate a lot.
Speaker Change: Got it.
Speaker Change: That's super helpful. Thanks, So much Brian.
Brian Lian: Thank you. Yeah, thanks for the questions. For the top-line data from the oral study, we've historically reported the top-line data when they're available, and so I would expect that's likely before the 4-week follow-up data are available. But keep in mind, they'll be top-line data. With the introduction of the auto-injector, that will be as soon as we can introduce it. I would say that's most likely early next year, and we will be doing a bridging study with the violin syringe comparing to the auto-injector in the interim.
Speaker Change: So thats.
Speaker Change: Thanks, Andy.
Speaker Change: I think that's really interesting.
Speaker Change: Our next question comes from Brian Aman.
Speaker Change: The.
Speaker Change: Half lives each compound is a little different.
Speaker Change: Piper Sandler. Please go ahead.
Speaker Change: Yes, Thanks, guys for taking my questions for the oral <unk> Phi program is.
Speaker Change: The ambulance, obviously different test side than the dual agonist. So.
Speaker Change: As the formulation locked down or are you.
Speaker Change: I don't know that <unk> bin.
Speaker Change: Doing anymore formulation optimization work.
Speaker Change: Translate a whole lot since the molecules are different we do think the PK profile is.
Brian: Yes, Thanks, Brian we're always doing.
Speaker Change: It's supportive of a weekly regimen, but.
Speaker Change: Additional.
Speaker Change: Experimentation with the formulations.
Speaker Change: Other than that.
Speaker Change: But I think right now we're we're pretty set with this formulation, we may make a minor change to the to the formulation but.
Speaker Change: I guess.
Speaker Change: Since it is a different molecule, it's hard to translate a lot.
Speaker Change: Got it.
Speaker Change: That's super helpful. Thank you so much Brian.
Andy Shay: Thanks, Andy.
Speaker Change: Nothing that would be I think considered.
Speaker Change: Our next question comes from Brian Aman.
Asim Rana: Thank you, guys. Thanks.
Speaker Change: Two significant.
Speaker Change: Got it and then for the monthly sub Q regimen that youre, hoping to test in a trial. Later this year can you maybe disclose how many patients what type of treatment duration is a three month study.
Andy Shay: Piper Sandler. Please go ahead.
Brian Aman: Thanks, guys for taking my questions for the oral <unk> Phi program is.
Mike Ulz: The next question comes from Mike Ulz with Morgan Stanley, please go ahead. Good afternoon and thanks for taking the question. Maybe just one on the Phase 2 Venture Oral Data that you plan to share in the second half of this year. Just curious if there's a specific level of weight loss you're looking to achieve there and how do you think about that level of weight loss at the lower doses versus the higher doses?
Andy Shay: As the formulation locked down or are you.
Brian Aman: Doing anymore formulation optimization work.
Speaker Change: And I assume that you would need to run a separate phase III would that regimen later on.
Brian Lian: Yes, Thanks, Brian we're always doing.
Speaker Change: Yes, we don't know what the substance of the subsequent study would be to either be a.
Brian Aman: Additional.
Brian Aman: Experimentation with the formulations.
Speaker Change: A dedicated longer phase two or phase III.
Brian Aman: But I think right now we're we're pretty set with this formulation, we may make a minor change to the to the formulation but.
Speaker Change: Not clear yet.
Speaker Change: And as far as the.
Brian Lian: Yeah, thanks, Mike. Hard to project. It's a larger study than the phase one, but it's obviously dosing longer as well. So I think if we can show 8% or so, which is what we showed at the high dose last time, if we can show that after 12 weeks, I think we'd have a competitive profile. But really hard to know. prior to, you know, unblinding the data. And with the lower doses, yeah, just really hard to prognosticate on what the efficacy might be. Hopefully, over time, as you see continued accumulation, you'll see those lower doses perform well.
Speaker Change: The number of doses, we havent disclosed that the first study would be.
Brian Aman: Nothing that would be.
Speaker Change: More of a PK study to look at exposures and what did the exposures looked like when you transition someone from a.
Brian Aman: I think considered.
Brian Aman: Two significant.
Brian Aman: Got it and then for the monthly sub Q argument that youre, hoping to test in a trial. Later this year can you maybe disclose how many patients what type of treatment duration is that a three month study.
Speaker Change: Weekly regimen to a monthly regimen.
Speaker Change: But so you're thinking not not 50 or 60 per arm a lot lower than that more like a PK study.
Brian Aman: And I assume that you would need to run a separate phase III with that regimen later on.
Speaker Change: But as far as the overall.
Speaker Change: Yes, we don't know what the subsequent the subsequent study would be to either be a.
Speaker Change: Number in this study we'll disclose that once we start the study and duration is going to take a little while to get up to the top doses. So there is a titration element. There you can't just start people at the at the monthly.
Brian Aman: A dedicated longer phase two or phase III.
Speaker Change: Not clear yet.
Brian Aman: And as far as the.
Brian Aman: The number of doses, we havent disclosed that the first study would be more of a PK study to look at exposures and what did the exposures looked like when you transition someone from.
Speaker Change: Dosing load so.
Speaker Change: I would say probably a little longer than three months.
Brian Lian: But, you know. It's hard to tell.
Speaker Change: Perfect. Thank you.
Speaker Change: Thanks Barry.
Mike Ulz: Great, thank you.
Brian Aman: Weekly regimen to a monthly regimen.
Speaker Change: The next question comes from Thomas Smith with Leerink Partners. Please go ahead.
Brian Aman: But so youre thinking.
Ryan Deschner: The next question comes from Ryan Deschner with Raymond James. Please go ahead. Hi, thanks for the question.
Brian Aman: Not 50 or 60 per arm, a lot lower than that more like a PK study.
Thomas Smith: Hey, guys. Good afternoon, thanks for taking the questions.
Brian Aman: But as far as the overall.
Thomas Smith: Just with respect to the phase II <unk> oral study.
Brian Aman: Number in this study, we'll disclose that once we start the study and duration, it's going to take a little while to get up to the top doses. So there is a.
Brian Lian: I'm wondering how you're currently looking at the potential positioning of the DACA candidate, and if you were to evaluate its potential as a co-formulation with 2735, how early in the clinical progression of this candidate would you do that? Yeah, thanks, Ryan. So the first study there would be the typical SADMAD study like we did with the 2735 program. We would like to evaluate a combination regimen as soon as we can, but that probably wouldn't happen until, you know, next year sometime. We'd like to understand the single agent profile first. Thank you.
Speaker Change: Congrats on the rapid enrollment I was wondering if you could comment at all on the baseline characteristics.
Speaker Change: Patients who've enrolled there and how that compares to the phase II study for injectable 27 to 35.
Brian Aman: Titration element there you can't just start people at the at the monthly.
Tom: Great question, Tom I have not.
Brian Aman: Dosing load so.
Brian Aman: I would say probably a little longer than three months.
Speaker Change: Looked at that.
Speaker Change: The date of the demographic data there.
Brian Aman: Okay.
Speaker Change: What we've seen in the past is that.
Brian Aman: Perfect. Thank you.
Brian Aman: Thanks Barry.
Speaker Change: The body weight right around 100, the BMI as we are in the mid Thirty's.
Speaker Change: The next question comes from Thomas Smith with Leerink Partners. Please go ahead.
Speaker Change: I have no reason to believe this trial would be different but but I don't know I just haven't looked at that that information.
Speaker Change: Hey, guys. Good afternoon, thanks for taking the questions.
Speaker Change: Just with respect to the pace of inventor oral study.
Speaker Change: Understood and then just.
Speaker Change: Congrats on the rapid enrollment I was wondering if you could comment at all on the baseline characteristics of the patients even more there and how that compares to the phase II study for injectable 27 35.
Speaker Change: A follow up if I could on the manufacturing and supply front.
Speaker Change: I appreciate the scale of the Corden pharma deal, but could you comment on whether you think you need additional commercial capacity of redundancy and what the plan would be for that thanks.
Jay Olson: We have the next question from Jay Olson with Oppenheimer. Please go ahead. Oh, hey, congrats on the progress, and thanks for taking the questions.
Tom: Great question, Tom I have not.
Speaker Change: Looked at that.
Speaker Change: Yes, yes, great question, we do plan to have redundancy across all elements of the supply chain.
Tom: The date of the demographic data there.
Tom: What we've seen in the past is that.
Brian Lian: Are you planning to test oral VK2735 and other indications besides obesity, like type 2 diabetes? And then I had a follow-up. Yeah, thanks, Jay. Well, the phase three program will consist of one study in obese subjects and one study in obese diabetics. And so in that second study, you know, those will be type two patients. And we'll be looking at Weight Change and Glycemic Control. But that will give us a lot of really useful data.
Tom: The body weights are right around 100, the BMI as we are in the mid <unk>.
Speaker Change: And thats, partly in anticipation of demand, but also just as a safety mechanism to have a backup in case something were two.
Tom: I have no reason to believe this trial would be different but but I don't know I just haven't looked at that that information.
Unexpected were to happen. So we do expect to put in place redundancies across the board.
Tom: Understood and then just.
Speaker Change: A follow up if I could on the manufacturing and supply fronts.
Speaker Change: Got it that makes sense, thanks for taking the questions.
Speaker Change: Appreciate the scale of the Corden pharma deal, but could you comment on whether you think you need additional commercial capacity of redundancy and what the plan would be for that thanks.
Thomas Smith: Okay. Thanks, Tom.
George Farmer: The next question is from George Farmer with Scotia Bank. Please go ahead.
George Farmer: Hi, Thanks for taking my questions. Brian can you comment on your level of comfort with.
Speaker Change: Yes, yes, great question, we do plan to have redundancy across all elements of the supply chain.
Speaker Change: Any food or factor liquid effect on absorption of 2735 that you need to.
Jay Olson: Oh, okay, great. Thank you for that.
Speaker Change: And thats, partly in anticipation of demand, but also just as a safety mechanism to have a backup.
Jay Olson: And then, can you share any comments on recent obesity deals, especially for novel targets and small molecules and acids? Coming out of China, maybe comment on the overall level of... Strategic Interests in the Obesity Space. Yeah, it's hard for us to comment on any VD-type discussions, but I'd say there continues to be high interest in the space, and I think we have a very attractive portfolio. Yeah, hard to give a lot of color on further discussions there. Okay, fair enough. Thanks for taking the question. Thanks, Jay.
Speaker Change: Engage in any further exploration or it that can be part of that been part of our future studies.
Speaker Change: Something we're two two.
George Farmer: Yes, Thanks, George we have not done a food effect study.
Speaker Change: Unexpected were to happen. So we do expect to put in place redundancies across the board.
George Farmer: We'll do a food effect study and it's a large molecules. So I would certainly expect there to be a food effect, but we havent done the study.
Speaker Change: Got it that makes sense, thanks for taking the questions. Okay.
Speaker Change: Okay. Thanks, Tom.
Speaker Change: At this point, okay, so youre comfortable without.
George Farmer: The next question is from George Farmer with Scotia Bank. Please go ahead.
Speaker Change: I understand that right now.
George Farmer: Going into.
George Farmer: Hi, Thanks for taking my questions. Brian can you comment on your level of comfort with.
Speaker Change: No any additional studies to think.
Speaker Change: Or is that something that'll be elucidated on the outcome of the phase II.
George Farmer: Any food effect or liquid effect on absorption of 20 735 million that you need to.
Speaker Change: Well, let's say that after we get done with the phase II, we have to see what the what the profile looks like in the phase II study one.
George Farmer: Yes engage in any further exploration or is that going to be part of that's been part of our future studies.
Speaker Change: Okay and then.
Speaker Change: Do you expect any sort of competition for API, starting materials with Lilly and Novo.
Hardik Parikh: The next question comes from Hardik Parikh with JP Morgan, please go ahead. Hey Brian, thanks for the updates today. I think in the past you've mentioned that you were sorting through some logistics before kind of initiating the phase three for 2735. I was wondering if you can kind of provide us an update there. And then are the remaining to-dos, are they more regulatory in nature, like with FDA, or are they more internal operational items? And then the second part is, is there any chance that the initiation of the phase three bleeds into 3Q? Thank you.
Speaker Change: Yes, Thanks, George we have not done a food effect study.
Speaker Change: We'll do a food effect study and it's a large molecules. So I would certainly expect there to be a food effect, but we havent done the study.
Speaker Change: As certainly as slowly start scaling up manufacturing of tours appetite.
Speaker Change: You guys have adequate supply of 2735 going forward.
Speaker Change: At this point, okay, so youre comfortable without understanding that right now we're going into.
Speaker Change: Yes, so when we talk to suppliers about that we have not.
Speaker Change: No any additional studies to think.
Speaker Change: Had anyone raise any alarms on.
Speaker Change: What does that say something that'll be elucidated on the outcome of the phase II.
Speaker Change: Starting materials being in short supply so.
Speaker Change: Yes, well, let's say that after we get done with the phase II, we have to see what the what the profile looks like in the phase II study one.
Speaker Change: I don't know, but no one has mentioned that to us so it seems like.
Brian Lian: Thanks, Hardik. Well, right now, we plan to initiate the study in the second quarter, and there's no reason to think we can't do that. As far as what is happening in preparation for the study, primarily, it's logistical, getting the supplies ready, getting the sites up and ready, and a lot of different doses. There will be a titration scheme in the study, so having the proper number of doses labeled, manufactured, and prepared for administration, it's a big lift. It's a lot of people, a lot larger overall program than the Phase IIa study. Okay, thank you.
Speaker Change: Okay and then what.
Speaker Change: The starting materials should be.
Speaker Change: Do you expect any sort of competitive competition for API, starting materials with Lilly and Novo.
Speaker Change: Available as we scale up.
Speaker Change: Okay. Thanks.
Speaker Change: As certainly is literally start scaling up manufacturing of <unk> appetite.
Thanks George.
Speaker Change: The next question comes from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Speaker Change: You guys have adequate supply of $27 35 going forward.
Yale Jen: Good afternoon, thanks for taking the questions.
Speaker Change: Yes, so when we talk to suppliers about that we have not.
Yale Jen: Just wanted to see what are you guys.
When you thought of phase III harmony correct.
Speaker Change: Had anyone raise any alarms on.
Yale Jen: We will be prepared and what might be the ultimate number of sites.
Speaker Change: Starting materials being in short supply so.
Yale Jen: The third at progressive.
Speaker Change: I don't know, but no one has mentioned that to us so it seems like.
Yale Jen: And then another follow up question here is that there are any.
Yale Jen: This report in terms of the partnering either.
Speaker Change: The starting materials should be.
Yale Jen: Zero to one four or 20 overnight and thanks.
Speaker Change: Available as we scale up.
Hardik Parikh: The next question comes from Mayank Mamtani with B. Reilly Securities. Please go ahead. Yes, good afternoon. Thanks for taking our questions and congrats on the progress, Brian, on multiple farms. So, on the manufacturing side with Garden Pharma, are you able to comment on what sort of cogs you're targeting in a steady state and maybe differences between peptide and oral and, you know, any metrics we should be looking at API per year or something like that? And then I have a quick follow-up. No, I think I think it's hard to Talk about cogs, those are pretty tightly I'd say we'll have margins that are consistent with other peptide products, nothing unusual about what the margins might be.
Speaker Change: Okay. Thanks.
Speaker Change: Thanks George.
Yale Jen: Yes, thanks, Sheila with the thyroid programs both are available for licensing.
Speaker Change: The next question comes from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Yale Jen: <unk>.
Yale Jen: Good afternoon, thanks for taking the questions.
Yale Jen: So we're always receptive to two interest in those programs and then there is some some interest in the programs. We just don't give a lot of detail on that on the ongoing any anything it's ongoing.
Speaker Change: I'd like to see what are you at.
Speaker Change: When you thought a phase III study, how many conquer youll get there.
Speaker Change: Paired and what might be the ultimate number of sites.
Yale Jen: With the phase III footprint.
Speaker Change: The study progress and then another follow up question here is there any status report in terms of the partnering either.
Yale Jen: Uh huh.
Yale Jen: Hard to give a lot of details on the number of sites. Obviously big studies. Both of the studies are large they'll use a lot of the same sites that lease up a fair amount of.
Speaker Change: Zero to one four or 20 O and thanks.
Yale Jen: Independent sites for each study as well, but we haven't disclosed the number of patients or the number of sites or anything like that at this point.
Speaker Change: Yes, thanks, Neil with the thyroid programs both are available for licensing.
Speaker Change: And.
Speaker Change: So we're always receptive to.
Speaker Change: Okay, great Thanks, and congrats on the progression.
Brian Lian: The scale of the manufacturing agreement is large. There are tiers to pricing as scale increases, so we think that's very favorable to us. but unable to give granularity on specific prices.
Speaker Change: Interest in those programs and then there is some some interest in the programs. We just don't give a lot of detail on the on the ongoing any anything it's ongoing.
Yale Jen: Thanks Jill.
Speaker Change: The next question comes from <unk> Mukherjee with BT.
Speaker Change: Please go ahead.
Speaker Change: Great. Thanks for taking the questions two from me just given the good maintenance of weight loss you saw in the phase. One oral study are you meaningfully evaluating dosing regimen with longer than once a day for that and the second question was just around thoughts of pace of enrollment in your phase III trials given the rapid enrollment you saw in the phase II <unk> study. Thank you.
Speaker Change: With the phase III footprint.
Speaker Change: Hard to give a lot of details on the number of sites. Obviously big studies both of the studies are large they'll use a lot of the same sites.
Brian Lian: Okay. And nothing between the peptide versus oral.
Brian Lian: And on the oral study, quickly, Brian, remind us of the objective for this 30 mg maintenance that you have in follow-up to the 90 mg cohort you're doing, and maybe just help us understand how to think about that data versus, say, a regular 90 mg that you're doing versus the higher-dose 120 mg. We're just trying to do 30 mg maintenance. Thanks for taking the time. Yeah, sure. Well, with the that step down, so you titrate up to 90. And then I think people stay there for four weeks or so. And then and then you come down to 30 for the for the five remaining weeks.
Speaker Change: Fair amount of.
Speaker Change: Independent sites for each study as well, but we haven't disclosed the number of patients or the number of sites or anything like that at this point.
Speaker Change: Yes. Thanks.
Speaker Change: With the.
Speaker Change: Pacer role in phase III.
Speaker Change: Okay, great Thanks, and congrats on the progression.
Speaker Change: Much larger studies, but it is encouraging to see this.
Speaker Change: Thanks, Jim.
Speaker Change: The next question comes from <unk> Mukherjee with BTG. Please go ahead.
Speaker Change: Speed of enrollment and the continued high level of interest.
Speaker Change: Among <unk>.
Speaker Change: Study participants and clinician. So hopefully that continues in phase III, but we won't know until we really get it up and running.
Speaker Change: Great. Thanks for taking the questions two from me just given the good maintenance of weight loss you saw in the phase. One oral study are you meaningfully evaluating dosing regimen with longer than once a day for that and the second question was just around thoughts of pace of enrollment in your phase III trial, given the rapid enrollment you saw on the phase two oral study. Thank you.
Speaker Change: With the oral.
Speaker Change: No.
Speaker Change: Persistence of effect in the phase one study it is something that we would like to explore in the in the upcoming maintenance study. So we will likely explore something less frequent than a daily dose in that study.
Brian Lian: That's really to understand if you can come down from a high dose to a lower dose and, and prevent weight gain. And sort of just a quick and dirty test on low-dose maintenance. We think it should... provide sufficient drug to prevent weight gain. When we've always thought the oral would be well utilized in a low-dose maintenance setting, once you've lost weight down to some target range, you can transition potentially to a monthly injection or to a daily low-dose oral. So this is just one way to understand that possibility a little bit better. I mean, it'd be even better if weight loss continues, which is a possibility, but I think our goal here is to understand if at least we prevent weight regain.
Speaker Change: Yes, Thanks, Jim.
Speaker Change: The pace of roll in phase III.
Speaker Change: Much larger studies, but it is encouraging to see the speed of.
Speaker Change: Enrollment in the and the continued high level of interest.
Speaker Change: <unk>.
Speaker Change: Thank you.
Speaker Change: Study participants and clinician. So hopefully that continues in phase III, but we won't know until we really get it up and running.
Speaker Change: At this time, we must end the call.
Speaker Change: The company apologizes for those questions that we were unable to answer here.
Speaker Change: With the oral.
Speaker Change: I would now like to turn the conference back over to Stephanie Diaz for any closing remarks.
Speaker Change: Kind of persistence of effect in the phase one study it is something that we would like to explore in the in the upcoming maintenance study. So we will likely explore something less frequent than a daily dose in that study.
Speaker Change: Thank you again for your participation and continued support of Viking Therapeutics, we look forward to updating you again in the coming months. Thank you.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Hardik Parikh: Got it. Thank you.
Speaker Change: Thank you.
Annabel Samimy: The next question comes from Annabel Samimy with Stifel, please go ahead. Hi. Thanks for taking my question. I appreciate it.
Speaker Change: At this time, we must end the call.
Speaker Change: The company apologizes for those questions that we were unable to answer here.
Brian Lian: Just as far as the Phase 3 for the injectable, do you have a better sense of how you might incorporate the question of durability? I think you mentioned you were going to look at a monthly later on in the year, but is it possible it's going to be incorporated into the Phase 3 trials? And then for the autoinjector, you also said you were going to be conducting a bridging study. Does autoinjector need to be incorporated into the Phase 3 study in any way? Thank you all. The auto-injector, we'll introduce the auto-injector into the Phase 3, which is why we're doing the comparative study from the violent syringe to the auto-injector, so that's the reason As far as the monthly regimen, the first step there is to do the initial study which will involve a titration upward using the weekly regimen to some high dose level and then transition people onto the monthly regimen.
Speaker Change: I would now like to turn the conference back over to Stephanie Diaz for any closing remarks.
Speaker Change: Thank you again for your participation and continued support of Viking Therapeutics, we look forward to updating you again in the coming months. Thank you.
Speaker Change: The conference has now concluded.
Speaker Change: Thank you for attending today's presentation you may now disconnect.
Annabel Samimy: Whether or not we would introduce that into the phase three program is TBD. Right now, the phase three protocols do not incorporate that, but if there were an extension study or something like that, maybe that's a possibility to incorporate the monthly regimen. Got it.
Brian Lian: And as a follow-up, with dosing for the oral, if all of these doses are tolerable, will you likely keep the doses or start to pare them down as you move into Phase 3? Yeah, I think we'll have to see what the data look like. I think it's premature to pick doses now when we haven't seen any of the phase two data. Okay, thank you.
Operator: Yep, thanks everyone.
Roger Song: Our next question comes from Roger Song with Jeffreys. Please go ahead. Great. Thanks for taking our question and then for the update.
Roger Song: So, regarding the Phase 3, the Sub-Q, can you comment on the potential design of the Phase 3? How different and similar to other OPC trials have been conducted?
Brian Lian: And then regarding the AMLIN, what is the potential target profile you try to get before the IND, given we already see some preclinical data? And how much better do you want to be with AMLIN? Thank you. Yeah, thanks, Roger. Well, with the Phase 3 trials, we'll announce all the details as we initiate the studies, but I would say they'll conform to guidance. So, that is, you know, minimum of 4,500 people across, you know, total across the two studies, one in obese subjects, one in obese diabetics, and 52 weeks of post-titration treatment. As far as the doses and, you know, titration schemes, things like that, we'll wait to start the studies before we provide any further color on those.
Brian Lian: With the AMLIN program, we've done a lot of work with a lot of different compounds, looking at various combinations and formulation work to understand the best AMLIN candidate to bring forward. And that took quite a while, but I think we have a really interesting compound. So we'll bring that into the clinic. It'll be a weekly, you know, long-acting amylin. We'll bring that into the clinic, hopefully by the end of the year. Thank you. Thanks, Roger.
Andy Shea: The next question comes from Andy Shea with William Blair, please go ahead. Thanks for taking our questions, and congratulations on the progress. For the maintenance studies that you're contemplating, I'm curious about the design frameworks you're considering. So, looking across some of the obesity studies with the maintenance components, like Atay with 2-step fatigue and ofraclipron. Triam-6 with recapitized, none of them actually use the same compound transitioning from sub-q to oral, so we're just curious what parameters would you like to explore such as longer interval, lower doses, and do you need to read some sort of plateauing before the transition?
Brian Lian: Yeah, yeah. Thanks, Andy. Do you plateau on exposures or body weight you're referring to? Oh, body weight, so basically some sort of, you know, kind of plateau in body weight and then transition to the maintenance phase of that part of the study. Yeah, no, no, great, great question. Yeah, no, I don't think we'd want to wait for the plateau because I don't know when that might happen. It might happen, you know, quite a bit later. So, we would like to be able to titrate up to some elevated dose and then explore a less frequent regimen at a variety of doses and then also look at transition to an oral regimen as well.
Brian Lian: So, we get a lot of information from that study. Cool. That's helpful.
Brian Lian: And maybe a commercial question. I know this is, you know, maybe several years away, but with the success of... Lilly Direct, and also the complexity associated with contracting for rebates and discounting. I'm curious if direct-to-consumer models for the obesity market is already substantial and sufficient for kind of a standalone Viking to take a look at without going through all the complexity of negotiation, price negotiation, and that kind of stuff. Yeah, yeah, and it's a really great question. And I think in normal times, you probably would be more challenging. But what we've seen with the the introduction of these compound pharmacies and these other direct consumer models that don't don't have any sales force, that, you know, that is a viable channel.
Brian Lian: So you're right, it's a little early for us to make a decision like that. But the viability of that sort of model is, is pretty proven now. And so it, it gives us optionality, and it just opens different avenues to, to market the product.
Brian Lian: So great, and one more if I can squeeze in. So basically, the learnings that you gained from advancing BK2735, including potentially longer half-life, slow Tmax, oral formulation, how much of that can be applied to your AMLM? Yeah, it's a good question. We do think the amylins probably are amenable to oral formulation. And so I think that's really interesting. Half-lives, I mean, each compound is a little different. And the amylin's obviously a different peptide than the dual agonist. So I don't know that you can translate a whole lot since the molecules are different. We do think the PK profile is supportive of a weekly regimen.
Brian Lian: Other than that, I guess... Since it's a different molecule, it's hard to translate a lot. Got it.
Brian Lian: That's super helpful, thank you so much, Ryan. Yeah, thanks.
Biren Amin: Our next question comes from Biren Amin with Piper Sandler. Please go ahead. Yeah, thanks, guys, for taking my questions.
Biren Amin: For the Oral 2735 program, is the formulation locked down, or are you doing any more formulation optimization work? Yeah, thanks, man. We're always doing additional The experimentation with the formulations, but I think right now we're pretty set with this formulation. We may make a minor change to the formulation, but nothing that would be, I think, considered too significant. Got it.
Brian Lian: And then for the monthly sub-Q regimen that you're hoping to test in a trial later this year, can you maybe disclose, you know, how many patients, what type of treatment duration, is it a three-month study, and assume that you would need to run a separate phase three with that regimen later on? Yeah, we don't know what the subsequent study would be. It would either be a dedicated longer Phase II or a Phase III, not clear yet. And as far as the number of doses, we haven't disclosed that. The first study would be more of a PK study to look at exposures and what do the exposures look like when you transition someone from a weekly regimen to a monthly regimen.
Brian Lian: So you're thinking not 50 or 60 per arm, a lot lower than that, more like a PK study. But as far as the overall number in the study, we'll disclose that once we start the study. And duration, it's going to take a little while to get up to the top doses. So there is a titration element there. You can't just start people at the monthly dosing load. So I would say probably a little longer than three months. Perfect. Thank you.
Thomas Smith: Thanks, Pierre.
Thomas Smith: The next question comes from Thomas Smith with Lear Inc. Partners. Please go ahead. Hey, guys. Good afternoon. Thanks for taking the questions. Just with respect to the Phase II Venture Oral Study, congrats on the rapid enrollment. I was wondering if you could comment at all on the baseline characteristics of the patients who've enrolled there and how that compares to the Phase II Venture Study for injectable 27-13. A great question, Tom. I have not looked at the demographic data there. What we've seen in the past is that the body weights are right around 100. The BMIs are in the mid-30s.
Brian Lian: I have no reason to believe this trial would be different. But I don't know. I just haven't looked at that approach.
Thomas Smith: Understood.
Biren Amin: And then just a follow-up, if I could, on the manufacturing and supply front. Appreciate the scale of the Cordon Pharma deal, but could you comment on whether you think you need additional commercial capacity or redundancy and what the plan would be for that? Thanks. Yeah, yeah, no, great question. We do plan to have redundancy across all elements of the supply chain. You know, and that's partly in anticipation of demand, but but also just as a safety mechanism to have a backup in case something were to to Unexpected. We're So we do expect to put in place redundancies across.
Biren Amin: Got it. That makes sense. Thanks for taking the question.
George Farmer: The next question is from George Farmer with Scotia Bank, please go ahead. Hi, thanks for taking my questions.
George Farmer: Brian, can you comment on your level of comfort with Any food effect or liquid effect on absorption of 2735 that you need to engage in any further exploration or has that been part of future studies? Yeah, thanks, George. We have not done a food effect study. We will do a food effect study. And it's a large molecule. So I would certainly expect there to be a food effect. But we haven't done the study.
Brian Lian: Okay, so you're comfortable without understanding that right now before going into, you know, any additional studies, do you think? Or is that just something that will be elucidated on the outcome of Phase 2? Yeah, we'll elucidate that after we get done with the phase two. We have to see what the what the profile looks like in the phase two study.
Brian Lian: Okay, and then do you expect any sort of competition for API starting materials, you know, with Lilly and OVO, as certainly as Lilly starts scaling up manufacturing of terzapatide, you know, for you guys to have adequate supply of 2735 going forward? Yeah, so when we talk to suppliers about that, we have not I don't know, but no one has mentioned that to us, so it seems like the starting materials should be Available as we scale up. Okay, thanks.
Yale Gen: The next question comes from Yale Gen with Laidlaw and Company, please go ahead. Good afternoon, and thanks for taking the questions. Just like to see, what do you anticipate when you start a Phase 3 study? How many current cases are you already prepared? And what might be the optimum number of sites as the study progresses?
Brian Lian: And then another follow-up question here is that any status report in terms of the partnering of either 0214 or 2809? And thanks. Yeah, thanks, Gilles. With the thyroid programs, both are available for licensing. And, you know, so we're always receptive to interests in those programs. And then there is some interest in the programs. We just don't give a lot of detail on the ongoing, anything that's ongoing. With the Phase III footprint, hard to give a lot of details on the number of sites. Obviously, big studies, both of the studies are large. They'll use a lot of the same sites.
Brian Lian: They'll use a fair amount of independent sites for each study as well. But we haven't disclosed the number of patients or the number of sites or anything like that at this point. Okay, great. Thanks and congrats on the progression.
Jeet Mukherjee: Thank you.
Jeet Mukherjee: The next question comes from Jeet Mukherjee with BTIG, please go ahead. Great. Thanks for taking the questions. Two for me.
Brian Lian: Just given the good maintenance of weight loss you saw in the Phase I oral study, are you meaningfully evaluating dosing regimens longer than once a day for that?
Brian Lian: And the second question was just around thoughts of pace of enrollment in your Phase III trials, given the rapid enrollment you saw in the Phase II oral study. Yeah, yeah, thanks. With the pace of enrollment in Phase 3, much larger studies, but it is encouraging to see, you know, the speed of enrollment and the continued high level of interest among, you know, study participants and clinicians. So hopefully that continues in Phase 3, but we won't know until we really get it up and running. With the oral, you know, kind of persistence of effect in the Phase 1 study, it is something that we would like to explore in the upcoming maintenance study.
Brian Lian: So we will likely explore something less frequent than a daily dose in that study.
Jeet Mukherjee: Thank you.
Operator: At this time we must end the call. The company apologizes for those questions that we were unable to answer here.
Stephanie Diaz: I would now like to turn the conference back over to Stephanie Diaz for any closing remarks. Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Thank you.
Operator: The conference has now concluded. Thank you for attending today's presentation.
Operator: You may now disconnect.