Picture supply: The Motley Idiot.
DATE
Wednesday, July 23, 2025 at 4:30 p.m. ET
CALL PARTICIPANTS
Chief Govt Officer — Brian Lian
Chief Monetary Officer — Greg Zante
Vice President, Investor Relations — Stephanie Diaz
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TAKEAWAYS
Analysis and Growth Bills: $60.2 million for the quarter ended June 30, 2025, up from $23.8 million within the prior yr interval, pushed by larger scientific, manufacturing, stock-based compensation, and personnel prices.
Basic and Administrative Bills: GAAP basic and administrative bills have been $14.4 million in Q2 2025. versus $10.3 million within the prior-year quarter, with will increase from stock-based compensation and salaries, partially offset by decreased authorized and patent bills.
Web Loss: $65.6 million, or $0.58 per share, for the quarter ended June 30, 2025, versus $22.3 million or $0.20 per share within the comparable prior-year interval, attributed to better analysis and working prices.
Money Place: $808 million in money, money equivalents, and short-term investments as of the tip of Q2 2025, down from $903 million at December 31, 2024.
Vanquish Section 3 Program Initiation: The pivotal Section 3 weight problems program with VK2735 started, consisting of two double-blind, placebo-controlled trials in weight problems and sort 2 diabetes, with enrollment targets of roughly 4,500 adults for weight problems and 1,100 adults for kind 2 diabetes, respectively.
VENTURE Section 2 Examine Outcomes: VK2735 subcutaneous met main and secondary endpoints, reaching as much as 14.7% weight reduction from baseline over 13 weeks within the Section 2 VENTURE examine, with “statistically important discount in imply physique weight” and “nearly all of treatment-emergent opposed occasions characterised as delicate or average.”
Sturdiness of Weight Loss: Greater than 90% of weight reduction was maintained seven weeks post-treatment, even on the lowest 2.5 mg weekly dose within the VENTURE trial, as offered on the 2024 Weight problems Week Convention.
Oral VK2735 Section 2 Examine Standing: Enrollment within the 13-week oral pill VENTURE examine (~280 adults) was accomplished in March 2025, with topline information anticipated within the second half of the yr.
Amyloid Receptor Agonist Program Progress: In vivo research confirmed promising physique weight and metabolic results; IND submitting is focused for This autumn 2025 (calendar yr).
Manufacturing Readiness: Secured a complete settlement for VK2735 API provide and fill/end capability to assist future commercialization.
R&D Expense Outlook: Greg Zante acknowledged, “our R&D bills can be going up a bit right here within the third and fourth quarter, you understand, in comparison with the second quarter perhaps by, you understand, 25% to a 3rd up mainly from right here ahead.”
SUMMARY
Viking Therapeutics (VKTX 4.27%) launched its pivotal Section 3 Vanquish program for VK2735, focusing on weight problems and sort 2 diabetes, and accomplished enrollment in its key Section 2 oral VENTURE examine. The VENTURE subcutaneous trial achieved as much as 14.7% weight reduction over 13 weeks in topics with weight problems, with most weight maintained post-treatment and favorable security information reported. A brand new IND for the amyloid receptor agonist program is scheduled for late 2025, highlighting sustained R&D pipeline development. The corporate’s money reserves place it to fund the complete Section 3 VK2735 program and extra pipeline actions.
VK2735 is being evaluated in each subcutaneous and oral pill formulations, narrowing the danger of tolerability points throughout route-of-administration transitions.
Administration confirmed that manufacturing provide wouldn’t constrain the startup of future Section 3 research.
The upcoming Vanquish trials will randomize members to certainly one of 4 weekly remedy arms: 7.5 mg, 12.5 mg, 17.5 mg, or placebo, designed for 78 weeks, together with titration and upkeep phases, within the Vanquish Section 3 trials of VK2735.
Viking expects to discover month-to-month upkeep dosing and a weekly oral dosing routine for VK2735 in upcoming research.
Individuals within the Vanquish placebo arm are eligible for open-label lively remedy extension, an method anticipated to assist retention charges.
Greg Zante forecast R&D expense development of 25% to 33% for Q3 and This autumn 2025, reflecting ongoing scientific exercise.
INDUSTRY GLOSSARY
API: Lively Pharmaceutical Ingredient, the primary lively compound in a drug product.
IND: Investigational New Drug utility, a regulatory submitting submitted to the FDA to start human scientific trials.
GLP-1 receptor: Glucagon-like peptide 1 receptor, a protein focused by anti-obesity and diabetic therapies to affect insulin secretion and satiety.
GIP receptor: Glucose-dependent insulinotropic polypeptide receptor, one other metabolic goal used along with GLP-1 focusing on for weight and glucose management.
Titration: The method of progressively growing a drug’s dose over a set interval to enhance tolerability.
Open-label extension: A examine section during which all members obtain the investigational drug, no matter earlier project.
Section 2/3 examine: Mid- and late-stage scientific trials, respectively, evaluating efficacy, security, and dosing in affected person populations for regulatory approval.
Full Convention Name Transcript
Brian Lian: Thanks, Stephanie, and good afternoon to everybody listening in by telephone or on the webcast. Immediately, we’ll evaluate our monetary outcomes for the second quarter and 6 months ended June 30, 2025, and supply an replace on latest progress with our improvement packages and operations. Within the second quarter, the Viking crew continued to give attention to executing. Throughout the first six months of 2025, the corporate superior each its VK2735 oral and subcutaneous packages additional in scientific improvement. With respect to the subcutaneous formulation, within the second quarter, we introduced the initiation of the Vanquish Section 3 registration program evaluating VK2735 in sufferers with weight problems. We’re excited to have these vital research underway.
Earlier within the yr, we additionally introduced each the initiation and the completion of enrollment in a Section 2 trial evaluating the oral pill formulation of VK2735 in topics with weight problems. We’re inspired by the examine’s speedy enrollment and we count on to announce the outcomes of this trial later within the yr. Additionally throughout the first six months of the yr, Viking made progress with its latest program evaluating novel agonists of the amyloid receptor. These compounds have demonstrated promising advantages on physique weight and metabolic profile in vivo fashions. We sit up for submitting an IND for this program within the fourth quarter of this yr.
Lastly, an vital milestone that was achieved throughout the first six months of 2025 was the announcement of a complete manufacturing settlement to supply VK2735 API, in addition to fill and end capability to assist the potential future commercialization of this compound. I am going to have further feedback on our operations and improvement actions following a evaluate of our second quarter and 6 months monetary outcomes. For that, I am going to flip the decision over to Greg Zante, Viking’s Chief Monetary Officer.
Greg Zante: Thanks, Brian. Together with my feedback, I would prefer to advocate that members consult with Viking’s Type 10-Q submitting with the Securities and Change Fee, which we count on to file shortly. I am going to now go over our outcomes for the second quarter and first six months of 2025, starting with the quarter. Analysis and improvement bills have been $60.2 million for the three months ended June 30, 2025, in comparison with $23.8 million for a similar interval in 2024. The rise was primarily because of elevated bills associated to scientific research, manufacturing for our drug candidates, preclinical research, stock-based compensation, and salaries and advantages.
Basic and administrative bills have been $14.4 million for the three months ended June 30, 2025, in comparison with $10.3 million for a similar interval in 2024. The rise was primarily because of elevated bills associated to stock-based compensation, and salaries and advantages, partially offset by decreased bills associated to authorized and patent companies. For the three months ended June 30, 2025, Viking reported a internet lack of $65.6 million or $0.58 per share, in comparison with a internet lack of $22.3 million or $0.20 per share within the corresponding interval in 2024.
The rise in internet loss for the three months ended June 30, 2025, was primarily because of the improve in analysis and improvement bills and basic and administrative bills famous beforehand in comparison with the identical interval in 2024. I am going to now go over our outcomes for the primary six months of 2025. Analysis and improvement bills have been $101.5 million for the six months ended June 30, 2025, in comparison with $47.9 million for a similar interval in 2024. The rise was primarily because of elevated bills associated to scientific research, manufacturing for our drug candidates, stock-based compensation, and salaries and advantages, partially offset by decreased bills associated to preclinical research.
Basic and administrative bills have been $28.5 million for the six months ended June 30, 2025, in comparison with $20.3 million for a similar interval in 2024. The rise was primarily because of elevated bills associated to stock-based compensation, authorized and patent companies, and insurance coverage, partially offset by decreased bills associated to third-party consultants. For the six months ended June 30, 2025, Viking reported a internet lack of $111.2 million or $0.99 per share, in comparison with a internet lack of $49.6 million or $0.46 per share within the corresponding interval in 2024.
The rise in internet loss for the six months ended June 30, 2025, was primarily because of the improve in analysis and improvement bills and basic and administrative bills famous beforehand, partially offset by elevated curiosity earnings in comparison with the identical interval in 2024. Turning to the stability sheet, at June 30, 2025, Viking held money, money equivalents, and short-term investments of $808 million in comparison with $903 million as of December 31, 2024. This concludes my monetary evaluate. I am going to now flip the decision again over to Brian.
Brian Lian: Thanks, Greg. I am going to now present an replace on our scientific pipeline and improvement packages beginning with our lead weight problems program VK2735. VK2735 is a twin agonist of the glucagon-like peptide 1 or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide or GIP receptor. Viking is advancing each subcutaneous and oral formulations of VK2735 for the remedy of weight problems. Prior Section 1 outcomes for the subcutaneous formulation of VK2735 demonstrated promising security, tolerability, and pharmacokinetics, with handled topics demonstrating as much as roughly 8% weight reduction from baseline after 28 days of once-weekly dosing with no indicators of plateau.
Primarily based on these outcomes, Viking initiated a 13-week Section 2 examine referred to as VENTURE designed to guage the security and weight reduction results of VK2735 in topics with weight problems. The VENTURE examine efficiently achieved each its main and secondary endpoints, with topics receiving VK2735 demonstrating statistically important discount in imply physique weight from baseline ranging as much as 14.7%. The examine additionally confirmed VK2735 to be secure and well-tolerated by means of 13 weeks of dosing, with nearly all of treatment-emergent opposed occasions characterised as delicate or average. Adversarial occasions usually occurred early in the middle of remedy and have been primarily associated to the anticipated gastrointestinal results ensuing from activation of the GLP-1 receptor.
These outcomes, in addition to further information from the examine’s follow-up visits, have been highlighted in a presentation on the 2024 Weight problems Week Convention. This presentation confirmed that topics receiving VK2735 maintained nearly all of their weight reduction by means of follow-up visits occurring as much as seven weeks after the final dose of VK2735 was administered. This included the two.5 mg weekly dose, which was the bottom dose evaluated, for which over 90% of the preliminary weight reduction was maintained seven weeks after the final dose was given. In a subset of members, analysis of plasma ranges of VK2735 was carried out at varied time factors following completion of the 13-week dosing interval.
We imagine the pharmacokinetic outcomes from this examine assist the potential for once-monthly dosing within the upkeep setting, and the corporate plans to additional consider a month-to-month dosing routine later this yr. Primarily based on the VENTURE Section 2 examine outcomes, and following receipt of suggestions from a Sort C assembly with the FDA, and a subsequent end-of-Section 2 assembly with the company, the corporate superior VK2735 into Section 3 improvement for weight problems. To this finish, final month, we introduced the initiation of the Vanquish Section 3 program. The Vanquish research include two trials evaluating VK2735, one in adults with weight problems, and one in overweight or obese adults with kind 2 diabetes.
Every examine is a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy and security of VK2735 administered by subcutaneous injection as soon as weekly for 78 weeks. The Vanquish 1 examine is focusing on enrollment of roughly 4,500 adults with weight problems or adults who’re obese with a minimum of one weight-related comorbid situation. The Vanquish 2 examine targets enrollment of roughly 1,100 adults with kind 2 diabetes who’re overweight or obese. Individuals in each trials can be randomized to certainly one of 4 weekly remedy arms of seven.5 mg, 12.5 mg, 17.5 mg, or placebo.
The first endpoint of those trials is the p.c change in physique weight from baseline for members receiving VK2735 as in comparison with placebo after 78 weeks of remedy. Secondary and exploratory endpoints will consider a variety of further outcomes, together with the share of sufferers who obtain a minimum of 5%, 10%, 15%, and 20% physique weight discount. Every examine will embody an open-label extension permitting members the chance to proceed receiving remedy following completion of the first dosing interval. We’re excited to have these vital research underway and we are going to present additional updates on their progress as warranted. Throughout the second quarter, Viking additionally continued to advance its oral pill formulation of VK2735.
The corporate believes a pill formulation may symbolize a lovely remedy choice for individuals who might desire to provoke remedy with an oral remedy, or for these looking for to take care of the load loss they’ve already achieved. An vital differentiator for our weight problems program is that it consists of each a pill formulation and a subcutaneous formulation that make the most of the identical molecule. We imagine this may occasionally mitigate potential security or tolerability challenges that may happen when transitioning sufferers from one remedy to a different. In a previous Section 1 examine, the oral formulation efficiently achieved its goals, with cohorts receiving VK2735 demonstrating dose-dependent reductions in imply physique weight from baseline ranging as much as 8.2% after 28 days of day by day dosing.
As with the subcutaneous formulation, the preliminary weight reduction noticed within the Section 1 oral examine confirmed encouraging sturdiness, with as much as 8.3% reductions in physique weight from baseline noticed at follow-up visits by means of day 57, 4 weeks after the final dose was administered. The oral formulation of VK2735 additionally demonstrated encouraging security and tolerability by means of 28 days of once-daily dosing at doses as much as and together with 100 mg. Nearly all of noticed treatment-emergent opposed occasions have been delicate or average, with most reported as delicate. Equally, all noticed gastrointestinal opposed occasions have been reported as delicate or average, with the bulk reported as delicate. These outcomes have been offered on the 2024 Weight problems Week Convention final November.
Primarily based on the Section 1 outcomes, earlier this yr, the corporate introduced the initiation of a Section 2 examine of oral VK2735 in topics with weight problems. This examine, referred to as the VENTURE oral dosing examine, is a randomized, double-blind, placebo-controlled, multicenter examine designed to guage the security, tolerability, pharmacokinetics, and weight reduction efficacy of VK2735 dosed as an oral pill as soon as day by day for 13 weeks. The first endpoint of the examine is p.c change in physique weight from baseline after 13 weeks of remedy. Secondary and exploratory endpoints will consider a variety of further security and efficacy measures. In March, the corporate introduced that enrollment within the VENTURE oral examine had been accomplished.
The trial enrolled roughly 280 adults who’re overweight, or who’re obese with a minimum of one weight-related comorbid situation. Individuals have been evenly randomized to certainly one of six dosing arms or placebo. We sit up for reporting outcomes from this examine within the second half of the yr. Along with our packages centered on incretin analogs, Viking continues to advance a collection of novel agonists focusing on the amyloid receptor. Early information for this program has supported the thesis that activation of the amyloid receptor represents an vital further mechanism for regulation of urge for food and physique weight.
Throughout the second quarter, we continued to make progress with this program and we count on to file an IND with the FDA within the fourth quarter of the yr. To assist our pipeline, Viking continues to take care of fiscal self-discipline and a powerful stability sheet. As Greg reported, the corporate had greater than $800 million in money as of the tip of the second quarter. This supplies us with the runway to finish our deliberate Section 3 trial for VK2735 in weight problems, in addition to to aggressively pursue improvement of our further packages. In conclusion, the primary half of 2025 was an thrilling interval for the Viking crew.
With respect to our VK2735 weight problems program, we introduced the initiation of the Vanquish Section 3 registration program, together with trials in sufferers with weight problems, and weight problems with kind 2 diabetes. Additionally throughout the first half of the yr, we introduced the initiation and completion of enrollments in our Section 2 VENTURE oral dosing examine. We imagine the speedy enrollment we have noticed in our VK2735 trials speaks to a continued sturdy demand for brand new and differentiated weight reduction therapeutics. We stay on monitor to announce the top-line information from the VENTURE oral examine within the second half of the yr.
With respect to our amyloid agonist program, we proceed to make progress towards an IND submitting, which we count on to undergo the FDA later this yr. Lastly, our stability sheet stays sturdy, offering the runway to assist the development of VK2735 by means of Section 3 scientific trials, in addition to to make progress with different key packages. This concludes our ready feedback for immediately. Thanks for becoming a member of us, and we’ll now open the decision for questions. Operator?
Operator: We’ll now start the query and reply session. In case you are utilizing a speakerphone, and also you want to withdraw your query, please observe that we now have numerous members within the queue. The corporate will do its greatest to reply as many questions as doable. Thanks. Presently, we’ll pause momentarily to assemble our roster. And your first query comes from Ryan Deschner with Raymond James. Please go forward.
Ryan Deschner: Thanks. Within the Section 1 oral examine, you reported pretty sturdy dose dependence concerning satiety and decreased urge for food. Questioning in the event you would count on further improve in affected person satiety or decreased urge for food durations longer than 28 days within the Section 2 oral examine, significantly for the decrease doses, after which have a fast follow-up.
Brian Lian: Alright. Yeah. Thanks. You already know, you’d count on there to be some proof of satiety as weight reduction progresses, however we actually do not know. What we have seen in different research is that it is a considerably inconsistent sign. It would not all the time monitor dose or weight reduction. However it did, as you level out, within the Section 1 examine, so we’ll see what it does within the Section 2, however it’s a little inconsistent throughout different research.
Ryan Deschner: Bought it. Thanks, Brian. After which within the Section 2a readout, will this essentially embody information from all cohorts, particularly the upkeep dosing arm? At prime line? Thanks.
Brian Lian: Oh, yeah. Yeah. Thanks. It can embody the entire cohorts. It is a parallel cohort examine, in order that they’ll all be accessible on the similar time. And that is gonna be a very attention-grabbing cohort. The cohort that doses as much as 90 after which comes again to 30 for the remaining 4 weeks. Yeah. That is gonna be a very attention-grabbing cohort.
Ryan Deschner: Bought it. Thanks very a lot, Brian.
Brian Lian: Thanks, Ryan.
Operator: And your subsequent query comes from Joon Lee with Truist Securities. Please go forward.
Joon Lee: Thanks for the replace and for taking our questions. You already know, seamlessly transmitting from sub-Q to oral VK2735 for upkeep is absolutely enticing. Do you may have an oral dose in thoughts for the month-to-month dosing examine to start out in 3Q? And can you may have Section 2 oral VENTURE information out earlier than you begin the month dosing examine? Thanks.
Brian Lian: Sure. Thanks, Joon. We do not have a dose but as a result of we do not have the Section 2 oral information but. So vital information to guage after we choose these upkeep doses. It would not have to be, we need not have these information previous to initiating the upkeep examine. You already know, ideally, we might, however we do not have to because the transition to oral occurs after a while. There is a titration as much as a excessive weekly dose. So not necessary. It might be good, however not necessary.
Joon Lee: Thanks.
Brian Lian: Thanks, Joon.
Operator: And your subsequent query comes from Mayank Mamtani with B. Riley Securities. Please go forward.
Mayank Mamtani: Yeah. Sure. Good morning. Thanks. Hello. I ought to say good afternoon. Thanks for taking my questions, and congrats on the progress. So in your Section 3 Vanquish trial, you may have a prime dose of 17.5 mg. And also you look to go a slower titration scheme. Might you perhaps discuss slightly bit about your rationale for going up from 15 mg there and perhaps simply the schema, titration schema relative to your prior Section 2 trial.
Brian Lian: Yeah. Yeah. Thanks, Mayank. Yeah. Within the 13-week examine, we noticed actually wonderful tolerability and I feel actually encouraging efficacy at 15 mg. Properly, in all of the doses actually, however at 15 mg. So we thought that there was slightly little bit of room to perhaps go larger with out representing any significant distinction in security or tolerability. So that is what we proposed and that was okayed to proceed at that dose. So and with the titration scheme, it seemed good with the three-week cadence within the first examine.
You already know, totally different individuals have totally different sensitivities and it simply appeared like if we slowed it down, to 4 weeks between steps, perhaps if somebody had some problem with the tolerability, one other dose on the similar degree definitely would not harm. So we simply thought that extending it to a four-week block could be okay. And that is type of the usual presentation proper now with the industrial merchandise as nicely. So each of these type of fed into the choice.
Mayank Mamtani: Thanks. And is there a state of affairs in VENTURE oral which will compel you to check oral formulation as a frontline remedy? And likewise, like, a late-stage improvement which may look as expansive as ARFA. Thanks for taking our follow-up.
Brian Lian: Oh, yeah. Thanks. Exhausting to say. I imply, we actually have to see the info earlier than we map out the subsequent steps. I imply, yeah, there’s a state of affairs that it could possibly be a frontline remedy, but it surely’s untimely with out actually having a great take a look at the info but.
Operator: And your subsequent query will come from Jay Olson with Oppenheimer. Please go forward.
Jay Olson: Oh, hey. Congrats on the progress, and thanks for taking the questions. For the Section 3 Vanquish packages, have you ever began affected person dosing and may you share any tough predictions on how lengthy you count on enrollment to finish?
Brian Lian: Yeah. Sure. We’re dosing. And I feel it is simply untimely to make these timing projections. The examine’s, you understand, a month or so outdated. So it is tough to know what the true ramp is gonna appear to be. However to date, a whole lot of curiosity, a whole lot of enthusiasm, and I do know we’re pleased with the best way it is wanting proper now.
Jay Olson: Okay. Nice. Thanks. And if I may squeeze in a single follow-up for the subcu month-to-month upkeep examine. Are you planning to randomize with design?
Brian Lian: No. Folks can be titrated as much as a excessive dose after which simply transition to a variety of month-to-month doses or a number of day by day oral doses. That is type of the overall scheme.
Jay Olson: Okay. Bought it. Thanks.
Brian Lian: Thanks, Jay.
Operator: And your subsequent query comes from Hardik Parikh with JPMorgan. Please go forward.
Hardik Parikh: Hey. Thanks very a lot for the replace immediately. Only a two-part query on the oral program. So on the examine that is underway, yeah, I noticed that the arms with goal doses of 60 mg or larger have primarily six weeks of titration after which seven weeks on the goal dose. Simply questioning in the event you may present any particulars on the particular titration doses that you simply plan to make use of. After which the second half is simply wanna get your up to date ideas on the likelihood that the oral program can advance straight to Section 3 much like the subcu. Thanks.
Brian Lian: Yeah. Thanks, Hardik. The steps with the Section 2, yeah, in the event you’re at 60 and above, you titrate in two-week blocks. So, like, the 90 goes, I feel it goes 30, 60, 90 at two-week blocks. The 120 is 30, two weeks. You already know, 60, 90 to 120. So the two-week blocks there. And whether or not or not we may go to Section 3, unclear. Let’s take a look on the information first. However, I imply, ideally, however unsure simply but. Now we have to see the info. Thanks.
Hardik Parikh: Yeah. Thanks, Brian.
Operator: And your subsequent query comes from Mike Ulz with Morgan Stanley. Please go forward.
Mike Ulz: Good afternoon. Thanks for taking my query. Perhaps only a follow-up on the upkeep examine. And I do not know in the event you can provide us a way of what number of cohorts you are contemplating at this level, after which additionally perhaps the way you’re fascinated by the speed length of remedy right here. Thanks.
Brian Lian: Yeah. Thanks, Mike. We’ve not given a whole lot of element there. It is a advanced and sizable examine. And so, you understand, in all probability greater than the VENTURE oral examine so far as the variety of arms since you’re gonna transition some individuals to a month-to-month injection after which others to a day by day oral and we’ll have a weekly oral in there as nicely. So it is a sizable examine, moderately advanced. The post-transition, so once you transition to month-to-month, or the day by day oral, that is going to be just a few months across the three-month window there. So you understand, you get some really feel for what the PK and what the physique weight curve appears like.
However we’ll have extra element after we provoke the examine.
Mike Ulz: Useful. Thanks.
Brian Lian: Thanks, Mike.
Operator: And your subsequent query comes from Steve Seedhouse with Cantor.
Steve Seedhouse: Hey. Thanks a lot. Simply wanna follow-up on the choice for the oral to maneuver into Section 3. Couple questions on that. One is do it is advisable meet with the FDA once more, or did you type of fulfill any questions or something that wanted addressing in your final assembly previous to beginning the subcutaneous Section 3 examine? After which additionally extra usually, simply the way you’re fascinated by type of the efficacy and tolerability hurdle that you simply’d wanna see finally to determine on pursuing that by means of a Section 3 examine?
Brian Lian: Yeah. Thanks, Steve. It is a totally different IND with the oral. So if we have been to, you understand, wish to go into Section 3, we would possible schedule an end-of-Section 2 assembly. So that will, you understand, if we have been to determine that, we might wanna have that assembly. The subcu would not assist us actually or do a lot for us. So far as the efficacy and tolerability, yeah, actually, it is a exhausting one to handicap. The, you understand, the Section 1 seemed actually encouraging on each. It is a longer dosing window, but it surely’s bigger as nicely. So with this, you understand, little little bit of a distinct titration scheme.
So actually, actually exhausting to know from these information what the subsequent step’s gonna be till we see the info, I imply.
Steve Seedhouse: Proper. Okay. What can I simply ask additionally, it appears like the road’s not precisely modeling the R&D expense line precisely? Are you able to simply perhaps present some steerage on the way you count on individually, you understand, the scientific trial expense, the manufacturing expense, which is a part now, and simply the general R&D line to evolve for the remainder of the yr?
Greg Zante: Hey, Steve. Yeah. I feel our R&D bills can be going up a bit right here within the third and fourth quarter, you understand, in comparison with the second quarter perhaps by, you understand, 25% to a 3rd up mainly from right here ahead. However that is the steerage I present there. And it is a combine, such as you stated, of, you understand, scientific trial, manufacturing, and different matters.
Steve Seedhouse: Nice. Thanks.
Operator: And your subsequent query comes from Roger Music with Jefferies. Please go forward.
Roger Music: Thanks for that replace and taking our questions. Two questions. So associated to the oral Section 2 upcoming information. So do you may have some expectation, simply give us some expectation across the excessive dose versus the upkeep dose given each of them can be informative to the subsequent steps for oral both, you understand, stand-alone or the upkeep. After which for the upkeep examine, would you be contemplating the weekly dose for oral given the how lengthy half-life after which perhaps fascinated by low dose for sub-Q as a weekly dose. Thanks.
Brian Lian: Yeah. Yeah. Thanks, Roger. So we’re a weekly with the oral in that upcoming examine. And, you understand, we’re not gonna get too far within the particulars, however that can be one cohort. With the excessive dose within the oral relative to a upkeep dose, I am unsure. Are you referring to a upkeep dose with the injectable versus the excessive dose oral or upkeep dose with the oral versus the excessive dose?
Roger Music: Oh, simply the oral Section 2, the upkeep cohort. You have got one cohort have the, I do not know, from excessive to the low cohort.
Brian Lian: Oh, yeah. Yeah. That one, so the best dose within the Section 2 is 120 mg. You titrate as much as 120 mg. After which that the upkeep cohort goes as much as 90 for, I imagine, 4 weeks, after which it comes again all the way down to 30 for the remaining 5 weeks. And so the upkeep is kind of a bit decrease in that upkeep dose is kind of a bit decrease than the best dose.
Roger Music: Sure. You already know, simply when it comes to expectation for the load loss after which tolerability and what you wanna see as you progress ahead with these regimens?
Brian Lian: Yeah. We have stated up to now to me, it is a robust one to handicap, and we noticed 8% within the 100 mg within the four-week examine. I feel if we have been to see 8% right here, I feel it could be about the very best oral information reported at the moment level. In order that’s type of the perhaps the hurdle we’re is, you understand, that is mid to excessive single digits. Someplace in there, that 8% vary. And with tolerability, I feel that is a really nuanced query. We clearly noticed excellent tolerability within the Section 1 examine.
However in Section 2, you understand, what we noticed within the injectable was some early, you understand, nausea and GI tolerability indicators, which you’d count on from the mechanism, however these waned virtually instantaneously. So second dose and later actually dropped off a cliff so far as tolerability. So it is advisable, I feel, contemplate the sample of any GI opposed occasions within the upcoming information set. And so it is exhausting to say, nicely, if we see x proportion, that is gonna be good or dangerous. It is simply what does the general remedy window appear to be so far as the AEs. And so that is what we’ll want to have a look at.
Operator: And your subsequent query comes from Biren Amin with Piper Sandler. Please go forward.
Biren Amin: Yeah. Hello, guys. Thanks for taking my questions. Wanna perceive the 78-week length for the Section 3 trials. Given you want 52 weeks for upkeep, these per FDA draft steerage, ought to we assume the titration interval within the Section 3 is 26 weeks? After which the second query is it is I feel it has been near a month because the Section 3 began. When can we count on to see the trials posted on scientific trials?
Brian Lian: Oh, with the second query, I might say shortly, very quickly. And with the primary query, yeah, it is 52 weeks plus the titration window. That is the way you get to 78.
Biren Amin: Bought it. After which perhaps if I may have a follow-up, Brian, you talked in regards to the oral information if it probably, you understand, reads out actually favorably that there is potential to go to Section 3. How lengthy would it not take to fabricate the outdated scientific provides in the event you make that call?
Brian Lian: Oh, I do not suppose that will be a gating issue. Now we have a number of batches type of in progress at any given time. So Section 3 provide wouldn’t be gating for initiation of a Section 3 examine there.
Biren Amin: Excellent. Thanks.
Brian Lian: How a lot we would have on day one, I do not know, however that would not be a gating issue.
Operator: And your subsequent query comes from Andy Hsieh with William Blair. Please go forward.
Andy Hsieh: Thanks for taking our questions. Only a follow-up on Biren’s query earlier. The 78 weeks, you understand, I suppose, a fast math. For those who subtract 52 weeks, that is 26. So that you type of talked about in regards to the four-week block on the earlier a part of this name. So I am interested by what’s in there that, you understand, prompted it not divisible by 4. After which the second half has to do with the Vanquish dosing scheme. So it looks as if it is slightly staggered relative to the depth sure. Clearly, your push goes slightly larger, hopefully, there’s some differentiation there from the magnitude weight reduction perspective.
However I am simply curious if there’s additionally a reimbursement, you understand, motivation there to make it a staggered feed. Thanks.
Brian Lian: I am unsure I perceive the second a part of the query. We’d count on if it have been, you understand, secure and efficient that, you understand, the reimbursement image could be much like different permitted brokers. So there wasn’t any actual, I do not know, consideration there so far as after we got here to the trial design. And with the titration window, yeah, I imply, it is 26 weeks on the early doses after which 52 on the ultimate doses.
Andy Hsieh: Okay. So perhaps let me make clear in regards to the reimbursement. So anecdotally, we’re listening to from physicians that if sufferers aren’t at certainly one of these upkeep doses for 5, ten, fifteen for that sure, some may get, you understand, their protection was withdrawn. So I am simply curious. That is actually motivated me for the query about…
Brian Lian: Yeah. No. I hear you. Yeah. We have heard that as nicely. However I feel that in that case, the 7.5 could be a very enticing choice for upkeep, if that is the dose they might, you understand, select to pursue long run. However I might count on all of them to be reimbursed. And people intermediate doses, that is one of many causes we, you understand, we did select three is simply to have you may have a number of choices of permitted ranges. So I suppose in that sense, it did feed into the design. However the ranges, I assumed, have been chosen actually primarily based on the potential for good security, tolerability, and efficacy.
Andy Hsieh: Okay. Nice.
Operator: And your subsequent query comes from Annabel Samimy with Stifel. Please go forward.
Annabel Samimy: Thanks for taking the query. So simply going again to the upkeep examine for a second. You had talked about that you simply’re in all probability seeking to transition sufferers from the titration to upkeep on the three-month time level. Simply interested by how you chose that three-month time level versus, say, six, provided that sufferers are in all probability shedding pounds past that time they usually will not see maximal weight reduction. So simply a few of the rationale behind that. Please. Thanks.
Brian Lian: So yeah. Thanks, Annabel. Sorry if it wasn’t clear. Once you transition to the month-to-month, that is three months. The time to get to that transition level is longer than three months. And actually, I feel the aim right here is to have a look at first, what doses are type of tolerated on a month-to-month cadence, after which additionally do you forestall weight acquire? Or, you understand, any type of regain. And in that sense, you do not have to have individuals at their, you understand, lowest potential dose.
You simply wanna have them at some degree of weight reduction that after they transition, you possibly can measure is the month-to-month going to forestall regain or help in additional weight reduction and simply, you understand, see how that works out.
Annabel Samimy: Okay. Nice. And if I may simply ask a fast follow-up, once you’re I do know that within the house you strive, you are quite a lot of doses going all the best way as much as 120 mg, and clearly the aim is to push the dose to see what the, you understand, most tolerability could possibly be, I suppose, and most weight reduction. However what do you see because the possible viable industrial doses for the oral provided that they are going to be upkeep? And is that actually how you’re looking at it? That there is some center dose that was in all probability essentially the most viable industrial dose?
Brian Lian: Yeah. It is a good query. And I feel that, you understand, decrease doses are, I feel, extra enticing within the upkeep setting for all the explanations all people is aware of. I imply, COGS and manufacturing and all that stuff. However, you understand, a very vital attribute on this examine is that arm that goes from 90 to 30. As a result of if that is attention-grabbing, then it could counsel that individuals do not have to be on a excessive dose for, you understand, an indeterminate variety of months. You already know, they may begin and get some momentum with a excessive dose after which transition to a decrease dose. So it is an attention-grabbing set of exploratory arm there.
So far as feasibility, you understand, larger doses are, as I stated, you understand, the margins are worse there. However what we now have seen up to now, I do not know, 9 to 12 months is a few regression, I feel, in value factors in peptide manufacturing. So the place that lastly plateaus, we do not know, however there was some enchancment on pricing, a minimum of from what we have seen from a few of the events we communicate with. So which may change what’s actually possible for oral dosing.
Annabel Samimy: Bought it. Nice. Thanks.
Brian Lian: Thanks, Annabel.
Operator: And your subsequent query comes from George Farmer with Scotiabank. Please go forward.
George Farmer: Hello. Thanks for taking my questions. Are you able to remark slightly bit on the way you’re fascinated by the placebo sufferers within the VENTURE examine and how one can proceed motivating them to stay on examine? Think about after some time if they are not shedding pounds, they’re going to rationalize that they are in all probability getting the placebo and should hop off. After which second, are you able to discuss slightly bit extra about your amyloid program and the way you suppose it is differentiated from the others which can be on the market? Thanks.
Brian Lian: Yeah. Yeah. Thanks, George. The placebo query is all the time a very robust one, particularly in these longer research. We’re, you understand, encouraging and counseling for weight loss plan and train, calorie prohibit for some individuals to some extent. The common visits with their clinician and the investigators, I feel that, you understand, some folks that resonates with them. They like to come back in and see the clinicians. I feel a giant attribute for us that can assist keep the placebo cohort is the eligibility to enter the open-label extension after the trial is finished. Each placebo recipient can be eligible to enter an lively arm. And we expect that can be a optimistic motivator to take care of participation.
However it’s undoubtedly a problem for any lengthy weight problems examine. From what the, you understand, the interior requirements we use are some recognized amyloid agonists. I feel we’re aggressive on urge for food discount, meals consumption discount, physique weight discount. So we have no human tolerability information but. However from the efficacy aspect, I feel it appears very aggressive so far within the animal fashions that we have checked out. So slightly untimely to make additional predictions there, but it surely appears attention-grabbing.
George Farmer: Mhmm. Okay. Thanks.
Brian Lian: Thanks, George.
Operator: And your subsequent query comes from Justin Zelin with BTIG. Please go forward.
Justin Zelin: Thanks for taking the query, and congrats on the progress. Brian, within the Vanquish packages, are you able to discuss how you’d use auto-injectors within the examine and in the event you would want, like, a bridging examine for the auto-injectors?
Brian Lian: Yeah. Thanks, Justin. Good query. We can be transitioning individuals to the auto-injectors subsequent yr, early subsequent yr. So that is the plan. We can be doing a bioequivalence examine within the interim that, you understand, assesses the auto-injector relative to the vial and syringe. So, you understand, that is the present plan.
Justin Zelin: Bought it. Okay. Nice. Thanks for taking the questions.
Brian Lian: Thanks, Justin.
Operator: And your subsequent query comes from Yale Jen with Leidlawn Co. Please go forward.
Yale Jen: Good afternoon, and thanks for taking the questions. It is a little bit in regards to the aggressive aspect on the orals. That the Lilly will report the orforglipron Section 3 information within the, I feel, on this quarter. So how do you see any influence from that to your oral presentation, oral product presentation? Additionally on this quarter.
Brian Lian: I do not know. Yeah. We’ll see what these information present. I feel, you understand, the Section 2 information seemed attention-grabbing for orforglipron. We’ll see what this longer examine reveals. I do not understand how exhausting to say. I feel it is secure to say although that the sector, the indication can accommodate a number of brokers given the market alternative. So, you understand, we do not suppose a single oral agent will actually be the, you understand, I imply, there’s gonna be a number of brokers within the house. So we’re not too apprehensive about one other one.
Yale Jen: Okay. Nice. Perhaps simply squeeze another. By way of the calcium channel and receptor, it appears not speaking about that immediately an excessive amount of. Was there any change within the standing? And thanks.
Brian Lian: No. No. We’re fairly balanced on Caledonia and amyloid. In our arms, the extra balanced, the higher the load loss is. Once you skewed a method or one other, it appeared to, I do not know, it did not actually influence meals consumption in addition to the extra balanced. And does that should be one to at least one? I do not know. Most likely not. However the nearer we obtained to at least one to at least one, the higher the general physique weight and meals consumption profile. So ours is, it’s each.
Yale Jen: Okay. Nice. Thanks, and congrats.
Brian Lian: Thanks, Yale.
Operator: As we’re nearing the conclusion of immediately’s name, our closing query will come from Thomas Smith with Leerink. Please go forward.
Matt (for Thomas Smith): Hello. That is Matt on for Thomas Smith. So for the amyloid agonist program, what does it have to indicate within the Section 1 trial, particularly in comparison with the VK2735 information, to warrant continued improvement in weight problems?
Brian Lian: I missed the primary half. Are you able to repeat the primary half?
Matt (for Thomas Smith): Yeah. So what does it have to indicate within the Section 1 trial, particularly in comparison with VK2735 information, to warrant continued improvement in weight problems?
Brian Lian: Yeah. Properly, I feel we want to see some influence on physique weight and be actually good to study what the tolerability profile appears like as nicely. I feel fortunately, we have moved previous the all people racing to the, you understand, four-week aim publish after which claiming victory, and you bought the very best compound within the class. So the house has matured past that type of foolish perspective towards four-week information. However we are going to see what the trajectory appears like, what the security and tolerability appear to be, after which decide from there.
Matt (for Thomas Smith): Bought it. Thanks.
Brian Lian: Thanks quite a bit.
Operator: This concludes our query and reply session. I want to flip the convention again over to Stephanie Diaz for any closing remarks.
Stephanie Diaz: Thanks once more in your participation and continued assist of Viking Therapeutics. We sit up for updating you once more within the coming months.
Operator: The convention is now concluded. Thanks for attending immediately’s presentation. You could now disconnect.
