Q3 2024 Viking Therapeutics Inc Earnings Call
Speaker Change: [music].
Yeah.
Speaker Change: Welcome to the Viking Therapeutics third quarter 2024 financial results Conference call.
Speaker Change: At this time all parties are in a listen only mode.
Speaker Change: Following managements prepared remarks, we will hold a question and answer session.
Speaker Change: To ask a question at that time. Please press the star followed by one on your Touchtone phone. If anyone has difficulty hearing the conference. Please press Star then zero for operator assistance.
Speaker Change: As a reminder, this conference is being recorded today akhil.
Speaker Change: October 23 2024.
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.
Stephanie Diaz: Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's, President and CEO and Greg Zante Viking's CFO.
Stephanie Diaz: Before we begin I'd like to caution that comments made during this conference call. Today October 23, 2024 will contain forward looking statements under the safe Harbor provisions of the U S. Private Securities Litigation Reform Act of 995, including statements about <unk> expectations regarding its development activity timelines and milestones.
Stephanie Diaz: 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.
Stephanie Diaz: 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.
Speaker Change: I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters I'll now turn the call over to Brian Lian for his initial comments.
Brian Lian: 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 three and nine months ended September 32024, and provide an update on recent progress with our clinical programs and operations.
Brian Lian: The first three quarters of 2024 have been data rich, providing with the company delivering positive data from four clinical programs as well as promising in vivo data from a new preclinical program.
Brian Lian: Beginning in the first quarter, we announced positive results from the phase II venture trial evaluating subcutaneous VK two 735 for the treatment of obesity.
Brian Lian: Trial demonstrated impressive reductions in body weight after 13 weeks of treatment.
Brian Lian: We also announced the initial results from a 28 day phase one trial evaluating a novel oral formulation of this compound showing excellent tolerability and encouraging reductions in body weight.
Brian Lian: During the second quarter, the company announced histology results from the Phase <unk> voyage study evaluating VK, two eight or nine for the treatment of Nash and fibrosis.
Brian Lian: This study successfully achieved its primary secondary and exploratory endpoints showing reductions in liver fat at 12 weeks and improvement in Nash resolution rate and fibrosis after 52 weeks.
Brian Lian: Also during the second quarter Viking announced in vivo results from a series of internally developed dual agonist of the amylin and calcitonin receptors.
Brian Lian: These compounds have demonstrated body weight reductions decreased food intake and improved metabolic profile in animal models.
Brian Lian: Finally, subsequent to the end of the third quarter, we announced positive results from a 28 day phase one b trial of VK 0214 in patients with X linked Adrenoleukodystrophy or X L D.
Brian Lian: <unk> from this study showed VK owed to one four to be safe and well tolerated following once daily oral dosing over the 28 day treatment period.
Brian Lian: In addition, significant reductions were observed in plasma levels of very long chain fatty acids, and other lipids as compared to placebo.
We are proud of the clinical progress we've made this year and look forward to further advancement of our pipeline programs in the quarters ahead.
I will have additional comments on our operations and development activities. After we review our financial results for the third quarter and nine months ending September 30th.
Speaker Change: For that I'll turn the call over to Greg Zante, Viking's, Chief Financial Officer.
Greg Zante: Thanks, Brian in conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later today.
Greg Zante: I'll now go over our results for the third quarter and nine months ended September 32024, beginning with the results for the quarter.
Greg Zante: Research and development expenses were $22 8 million for the three months ended September 32024, compared to $18 4 million for the same period in 2023.
Greg Zante: The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates stock based compensation salaries and benefits and regulatory services, partially offset by decreased expenses related to preclinical studies and clinical studies.
Greg Zante: General and administrative expenses were $13 8 million for the three months ended September 32024, compared to $8 9 million for the same period in 2023.
Greg Zante: The increase was primarily due to increased expenses related to stock based compensation legal and patent services services provided by third party consultants and insurance.
Greg Zante: For the three months ended September 32020 for Viking reported a net loss of $24 9 million or <unk> 22 per share compared to a net loss of $22 5 million or 23 per share in the corresponding period in 2023.
Greg Zante: The increase in net loss for the three months ended September 32024 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously partially offset by increased interest income compared to the same period in 2023.
Greg Zante: I'll now go over our results for the nine months ended September 32024.
Greg Zante: Our research and development expenses for the nine months ended September 32024 were $70 7 million compared to $43 3 million for the same period in 2023.
Greg Zante: The increase was primarily due to increased expenses related to manufacturing for our drug candidates clinical studies stock based compensation preclinical studies and salaries and benefits.
Greg Zante: Our general and administrative expenses for the nine months ended September 32024 were $34 million compared to $28 2 million for the same period in 2000 2023.
The increase was primarily due to increased expenses related to stock based compensation salaries and benefits.
Greg Zante: Services provided by third party consultants and insurance, partially offset by decreased expenses related to legal and patent services.
Greg Zante: For the nine months ended September 32020 for Viking reported a net loss of $74 5 million or <unk> 69 per share compared to a net loss of $61 3 million or <unk> 66 per share in the corresponding period in 2023.
Greg Zante: The increase in net loss for the nine months ended September 32024 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously partially offset by increased interest income compared to the same period in 2023.
Greg Zante: Turning to the balance sheet.
Greg Zante: At September 32000 to 2020 for Viking held cash cash equivalents and short term investments of $930 million.
Greg Zante: Third to $362 million as of December 31, 2023.
Greg Zante: This concludes my financial review and I'll now turn the call back over to Brian.
Brian Lian: Thanks, Greg.
Brian Lian: Now I'll provide a summary of recent clinical highlights and outline next steps with our pipeline programs.
Brian Lian: I'll begin with Viking's lead obesity program VK, two 735 dual agonist of the glucagon like peptide one or <unk>, one receptor and the glucose dependent insulin inotropic polypeptide or G IP receptor.
Brian Lian: The company's initial phase one single and multiple ascending dose trial for this compound demonstrated the promising safety tolerability and pharmacokinetics of VK two 735, when administered as a weekly subcutaneous injection for up to four weeks.
Brian Lian: Subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau.
Brian Lian: Following these results the company has initiated a phase II study of VK, two 735 known as the venture trial.
Brian Lian: This trial was a randomized double blind placebo controlled multicenter study that evaluated the safety Tolerability pharmacokinetics and weight loss efficacy of VK. Two 735 administered subcutaneously once weekly for 13 weeks.
Brian Lian: In the first quarter of this year Viking announced positive topline results from the venture studies with respect to the study's primary endpoint patients receiving VK, two seven and $3 five demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14, 7%.
Brian Lian: Statistically significant differences compared to placebo were also observed for all VK two to 705 doses starting at week, one and maintained throughout the course of the study.
Brian Lian: Weight loss in all treated cohorts was progressive through 13 weeks and did not show evidence of plateauing, suggesting that further weight loss could potentially be achieved through extended dosing beyond the 13 week period of this study.
Brian Lian: Regarding safety and Tolerability VK, two seven <unk> five was shown to be safe and well tolerated over the 13 week trial with the majority of treatment emergent adverse events being characterized as mild or moderate generally occurring early in the course of treatment and primarily related to expected Gi effects, resulting from activation of the <unk>.
Brian Lian: One receptor.
Brian Lian: This summer we submitted an abstract describing the results of the venture study for presentation at the annual meeting of the obesity Society also known as obesity week.
Brian Lian: The results will be highlighted in a poster session at the conference scheduled for the evening of November 3rd.
Brian Lian: Following completion of the venture study, we requested a type C meeting with the FDA to help US plan for next steps in the development of VK two 785.
Based on written feedback from the agency, we intend to advanced VK, two 735 into phase III development for obesity.
Brian Lian: To this end we have scheduled an end of phase II meeting with the agency later this quarter, which will serve to inform our next steps in the phase III plans for the program.
Brian Lian: Concurrent with the execution of the venture trial for subcutaneous VK. Two 735 banking also conducted a phase one study to evaluate an oral tablet formulation.
Brian Lian: The company believes a tablet formulation could represent an attractive treatment option for patients who are hesitant to initiate injection based therapy.
Brian Lian: Or for those seeking to maintain the weight loss. They have already achieved a key advantage. In this regard is the potential to transition patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule <unk>.
Brian Lian: <unk> believes this may reduce the risk of unexpected safety or tolerability challenges and could be an attractive option for both patients and clinicians.
Brian Lian: The phase one study was a randomized double blind placebo controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared.
Brian Lian: The primary objective was to evaluate the safety and Tolerability of VK $2 75 administered as a tablet once daily for 28 days.
Brian Lian: Secondary and exploratory objectives include an evaluation of the pharmacokinetics of oral VK $2 75, as well as changes in body weight and other metrics in.
Brian Lian: In the first quarter, we reported the initial data from this study, which demonstrated that CK 273, five was safe and well tolerated following once daily oral dosing for up to 28 days at doses of up to 40 milligrams.
Brian Lian: Among subjects, receiving VK two 735, all treatment emergent adverse events were reported as mild or moderate in severity with the majority of reported as mild.
Brian Lian: No clinically meaningful differences will reported for gastrointestinal adverse events among subjects treated with VK, two 735 compared with placebo.
Brian Lian: In addition patients receiving oral decay to 705 demonstrated dose dependent reductions in body weight, reaching up to approximately five 3% from baseline.
Brian Lian: Weight loss over the 28 day window of this study was progressive at the 20 milligram and 40 milligram dose levels with no plateau observed.
Brian Lian: Given the promising weight loss signal observed along with the excellent tolerability profile at doses of up to 40 milligrams per day. The company elected to continue dose escalation at doses of 60 milligrams 80 milligrams and 100 milligrams per day.
Brian Lian: As with debenture Phase II study results, we submitted a late breaking abstract describing the phase one trial for presentation at the obesity week conference.
Brian Lian: This submission was accepted for poster presentation, which is scheduled for the evening of November 3rd.
Brian Lian: As the next step we plan to initiate a 13 week phase II study in obesity later this year.
Brian Lian: We will provide details regarding study design as we get closer to trial initiation.
Brian Lian: I'll now turn to VK, two eight or nine viking's orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta Isa form of the receptor.
Brian Lian: During the second quarter, we announced positive histology results from the 52 week phase II. The voyage study of VK, two eight or nine in patients with Nash and fibrosis.
Brian Lian: This study was a randomized double blind placebo controlled multicenter international trial designed to assess the efficacy safety and Tolerability of VK, two eight or nine in patients with biopsy confirmed Nash and fibrosis.
Last year Viking announced the initial data from voyage reporting that the study had successfully achieved its primary endpoint with patients receiving VK, two eight or nine demonstrating statistically significant reductions in liver fat content from baseline to week 12, as compared with placebo.
Brian Lian: In June of this year Viking announced the successful achievement of the trial secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment.
Brian Lian: The histology results showed that patients receiving VK Twitter nine experienced clinically and statistically significant improvements in Nash resolution rate fibrosis stage and the combination endpoint of Nash resolution and fibrosis improvement.
Brian Lian: On the endpoint of Nash resolution without worsening of fibrosis Dk Twitter nine treated patients demonstrated resolution rates, ranging from 63% to 75% compared with 29% for placebo.
Brian Lian: On the secondary endpoint evaluating the proportion of patients demonstrating at least a one stage improvement in fibrosis with no worsening of Nash the proportion of VK, two eight or nine treated patients achieving this endpoint ranged from 44% to 57% compared with 34% for placebo.
Brian Lian: On the secondary endpoint evaluating the proportion of patients experiencing both the resolution of resolution of Nash and at least a one stage improvement in fibrosis that proportion of VK 209 treated patients achieving both measures ranged from 40% to 50% compared with 20% for placebo.
VK two eight or nine also demonstrated an encouraging safety and tolerability profile through 52 weeks of treatment with minimal differences reported when compared to the previous results from week 12.
Brian Lian: The majority 94% of treatment related adverse events among patients receiving VK, two eight or nine were reported as mild or moderate.
Brian Lian: <unk> also demonstrated excellent gastrointestinal tolerability through 52 weeks of treatment with similar rates of nausea, diarrhea, stool frequency and vomiting reported for VK Twitter nine treated patients as compared to placebo.
Earlier this fall we submitted the results of the voyage study for presentation at the 2024 annual meeting of the American Association for the study of liver diseases or a a S. L. D in November.
Brian Lian: These results have been accepted for an oral presentation, which is scheduled for November 19th.
In addition earlier this quarter, we submitted an end of phase II meeting package to the FDA regarding our proposed phase III study plan for VK, two eight or nine.
Brian Lian: Earlier. This week, we received written responses from the agency and we are in the process of reviewing them in evaluating next steps for the program.
Turning now to our fourth clinical program.
Brian Lian: We recently reported the results from a 28 day phase one b trial of our small molecule drug candidate VK OTI <unk> four in patients with the rare neuromuscular disorder called X linked Adrenoleukodystrophy or X L D.
Brian Lian: Like VK, two eight or nine <unk> to one four is an orally available small molecule that is selective for the beta isoform of the thyroid hormone receptor.
Brian Lian: <unk> is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of proxies domal transporter of very long chain fatty acids.
Brian Lian: As a result patients are unable to efficiently metabolized these assets and their accumulation is believed to contribute to the onset and progression of <unk>.
Brian Lian: Our phase one B trial was a multicenter randomized double blind placebo controlled international study in adult male patients with the adrenal Mylan neuropathy or <unk> form of <unk>.
Brian Lian: The study enrolled patients across three cohorts placebo and <unk> four doses of 20 milligrams and 40 milligrams daily the.
Brian Lian: The primary objectives were to evaluate the safety and Tolerability of <unk> in subjects with Amgen.
Brian Lian: An exploratory objective was to evaluate the effects of <unk> on plasma levels of very long chain fatty acids in this population.
Brian Lian: Results from this study showed <unk> to be safe and well tolerated following once daily oral dosing over the 28 day treatment period.
Brian Lian: In addition, significant reductions were observed in plasma levels of very long chain fatty acids, and other lipids compared to placebo.
Brian Lian: Treatment with <unk> four resulted in significant reductions in mean very long chain fatty acid levels at both the 20 milligram and 40 milligram doses compared to placebo plasma.
Brian Lian: Plasma levels of the important 26th carbon very long chain fatty acid will reduce by approximately 38% relative to placebo.
Brian Lian: In addition, subject to risks subjects, who received <unk> experienced reductions in other important plasma lipids.
Brian Lian: <unk> reductions relative to baseline and placebo were observed for LDL cholesterol April LIFO protein B and LIBOR protein a following 28 days of treatment.
Brian Lian: In this study.
Brian Lian: <unk> four demonstrated encouraging safety and tolerability with treatment emergent adverse events generally reported as mild to moderate.
Brian Lian: We're very pleased with the outcome of this study.
Brian Lian: We're continuing to receive data from the study and we will determine next steps for the program. Following a review of the complete dataset.
Brian Lian: Finally, as we move forward with our clinical programs. We're fortunate to have a strong balance sheet, providing the runway to execute on key clinical objectives with each program.
Brian Lian: In conclusion 2024 has been an exciting year for Viking as we have delivered positive results from four clinical programs.
Miles for subcutaneous VK two 735.
Brian Lian: Oral VK $2 75, VK, two eight or nine and VK <unk> for each successfully achieve their study endpoints. In addition to executing these programs we continue to explore new opportunities with innovative pipeline programs.
Brian Lian: To that end hiking recently announced our new internally developed amylin agonist program for the treatment of obesity.
Brian Lian: We're excited about the potential for this new program.
Brian Lian: And look forward to sharing updates as it advances.
Brian Lian: Looking ahead with respect to our obesity programs for subcutaneous VK. Two 735, we're actively preparing for an end of phase II meeting with the FDA, which will take place later this quarter following which we plan to initiate a phase III study.
Brian Lian: For oral VK two 735, we are preparing to present additional data at obesity week next month, and we plan to initiate a 13 week phase III study later this year.
Brian Lian: With respect to VK, two eight or nine for the treatment of Nash and fibrosis.
Brian Lian: We are evaluating next steps following our recent receipt of written responses to an end of phase II meeting with the FDA regarding the registration path for this program.
Brian Lian: With our small molecule <unk> four for <unk>, we await final data from this program and we will decide next steps once we have had a chance to review the full data package.
Brian Lian: Finally, with $930 million in cash and equivalents at the end of the third quarter. We believe we have the financial resources required to reach key clinical milestones for each of our programs and we look forward to reporting further progress in the quarters ahead.
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 to ask a question you May Press Star then one on your telephone keypad.
Speaker Change: If you're using a speaker phone.
Speaker Change: Please pickup 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.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
Our first question comes from Joon Lee.
Speaker Change: With truest. Please go ahead.
Joon Lee: Thanks for the update thanks for taking our questions.
Joon Lee: Regarding the end of phase II meeting for the sub Q VK, two 735 million for this quarter, what are some things you'd like to iron out with the FDA and how quickly would you be able to start phase III after that.
Joon Lee: And also as a quick follow up.
Joon Lee: Hamlin agonist, a backdrop or is it just semantics, what you call it and how you're benchmarking. Your agonist. Please that would be whats out there, whether it's called amylin agonist or background. Thank you.
Speaker Change: Yes, Thanks June with the Amazon agonist, yet as it is also hitting calcitonin. So it's a dual amylin and calcitonin receptor agonist.
Speaker Change: And we generally benchmark against known.
Amylin agonists.
Speaker Change: We use pramlintide Musica grill and tied so.
Speaker Change: We generally use.
Speaker Change: Compounds that are sort of the bellwethers.
As far as mechanism.
Speaker Change: With respect to the <unk>.
Speaker Change: End of phase two meeting with FDA.
We will review the proposed protocol the proposed doses. The proposed trial size all of those things and then try and understand if there's anything that we overlooked or anything that the FDA recommends.
Speaker Change: Included in the study so just a little feedback on the proposed trial designs.
Speaker Change: Alright, well looking forward to the update of the obesity week. Thank.
Thank you.
Speaker Change: Thanks, a lot Jim.
The next question comes from Annabel <unk> with Stifel. Please go ahead.
Speaker Change: Hi, Thanks for taking my question you've.
Speaker Change: You've talked about the potential for monthly dosing in the past will we be seeing that PK data and will you be incorporating that into the phase III program or as a separate trial.
Speaker Change: And I guess.
Speaker Change: Same question for oral dosing, you're exploring additional are you exploring additional dosing regimens and.
Speaker Change: Given this continued activity post dosing.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: With the monthly dosing, we will have some PK data in the venture poster and we think that the PK data do support.
Monthly dosing.
Speaker Change: Not going to disclose too much of whats in the poster but.
Speaker Change: We think that the monthly dosing is very feasible.
Speaker Change: As far as the inclusion of a monthly regimen in the phase III program will probably do.
Standalone, they're not included in the phase III the statistical treatment gets.
Speaker Change: More challenging when you transition.
Speaker Change: Mid study to two monthly so we would probably target a standalone are there to start.
Speaker Change: As soon as we can.
Speaker Change: Okay and for the orderly looking at a different.
Speaker Change: Dosing regimens Kevin.
It's activity post dosing that you saw in the four week study.
Speaker Change: Yeah.
Speaker Change: Oh, we may we will disclose the 13 week study design once we get closer to the to the actual study initiation.
Speaker Change: Okay, Great and just if I can have another question can you talk about the.
I guess the infrastructure and capacity builds that you have to do to run. These next trials or have you have you committed to increasing your personnel at this stage what are your expectations for how that expands here.
Speaker Change: Your your your infrastructure base. Thanks.
Yes, Thanks, Annabel, yes, we've typically relied heavily on external vendors I think thats been.
Speaker Change: It works very well for us and it's been an efficient model for us.
Speaker Change: We've been pretty aggressively adding to the staff now we've added in regulatory affairs clinical development.
Speaker Change: Manufacturing formulation clinical operations.
Speaker Change: <unk> access quality buyer.
Speaker Change: Bio statistics, so it's a pretty broad based increase in staff here and we've.
Speaker Change: We've continued to grow and we're continuing to to add so the phase II trial is a lot different than phase II trial, and we're going to be prepared for it.
Speaker Change: Okay, great. Thank you.
Speaker Change: Thanks Annabel.
Speaker Change: The next question comes from Steve Statehouse with Raymond James. Please go ahead.
Steve Statehouse: Yeah. Thanks, so much for taking the question couple protocol questions just for the Phase III study I'm wondering how you think about the pros and cons or whether it'll be necessary or advisable to have like an active control arm.
Steve Statehouse: In this study with one of the commercially available.
Steve Statehouse: Mechanisms.
Steve Statehouse: If that's the conversation that you anticipate having with FDA.
Speaker Change: Yeah. Thanks, Steve right now know we're planning to do a placebo controlled study I think an active comparator study would be of interest in a future study, but in these first two studies it will be placebo control.
Steve Statehouse: Okay sounds good and then on Emlen.
Steve Statehouse: Clinical development strategy question as well just how early in the development program.
Steve Statehouse: Or how are you thinking in general about testing that combination.
Steve Statehouse: With in this case to 735 or I guess, you could use it to.
Steve Statehouse: Another glib, but how are you thinking about.
Steve Statehouse: When it's appropriate and best to start looking at the combinations.
Speaker Change: Yes. Thanks.
Speaker Change: In our view the amylin the greatest value with that mechanism is in conjunction with another mechanism and typically what you see as a real nice improvement in efficacy. When you added on top of another mechanism with <unk> you see a 50% bump are so so.
Speaker Change: If you were to added onto a dual agonist.
Speaker Change: And it showed a similar improvement that would likely be the best in the industry efficacy profile and so that's something that we think is really a high value exercise to proceed with so we'll be hopefully, bringing a compound into the clinic.
Speaker Change: In 2025, and we would look at a single agent, but rapidly follow that with the potential combinations.
And just to follow up on that is that something that using the same approach. We've used with $2 735, you can formulate orally.
Speaker Change: And co formulate.
Speaker Change: With your oral <unk>.
Speaker Change: In future studies.
Speaker Change: We think so yes.
Speaker Change: Okay.
Speaker Change: Okay, and just lastly, I just want to clarify.
Speaker Change: Sort of obvious statement that you made in the press release, but I was hoping you could elaborate that you think.
Speaker Change: Further benefits from the oral dosing might be anticipated with longer dosing periods.
Speaker Change: But the press release does say based on observations in the phase one study.
If you can elaborate on or say about like just what observations you're referring to there what specific data points.
Speaker Change: What led you to conclude that.
Speaker Change: Yes, when you look at the trajectory at those.
Speaker Change: Whats been reported so far the 20 and the 40 milligram cohorts. The slopes were still negative 20 days is just such a short window to look at so.
Speaker Change: We think extending the dosing window would likely extend the trajectory further.
Speaker Change: Really what we're referring to there.
Speaker Change: Okay. Thanks, that's a reference to the already disclosed fortinet data essentially or not.
Speaker Change: That's right that's right, yes, we haven't disclosed anything with the subsequent cohorts. Okay. Thanks, so much.
Speaker Change: Thanks, Steve.
Speaker Change: The next question comes from Roger song with Jefferies. Please go ahead.
Speaker Change: Great.
Roger Song: Thanks for taking my question, so maybe I'll.
Brian Lian: It was a clarification Brian.
Roger Song: So.
Roger Song: And can confirm that you are they compete.
Roger Song: Dose escalation for you all to the 730 fives up to <unk>.
Roger Song: That's the case could you qualitatively comment on the dose response on their weight loss.
Brian Lian: Yes Lee.
Brian Lian: For the higher dose.
Brian Lian: Yes, Roger Yes, we did dose up to 100 milligrams and.
I think with.
Brian Lian: I'll leave the further disclosure of the results to the poster it's only in about 10 days. So we're probably going to limit further communication there.
The phase one study was intended to provide sufficient information to plan and execute a phase II study in <unk> and we think that it was successful in that regard and we look forward to getting the phase III underway as soon as possible.
Speaker Change: Got it yes. Thank you.
Speaker Change: That makes sense and then in terms of the.
Speaker Change: Passenger you may be focusing on that manufacturing.
Speaker Change: Daniel you probably already have the capacity for the Canadian coal.
Speaker Change: Trial or sub acute phase III and then for the oral phase Qi just curious for the <unk>.
Speaker Change: A couple of months, so what have you done Q, but.
Speaker Change: Increased manufacturing capacity for those.
Speaker Change: Those candidates.
Speaker Change: How do you stop shifted to Bob Patel.
Speaker Change: Potential commercial capacity. Thank you.
Speaker Change: Yes, Thanks, Roger Yes, Youre right. We do currently have on hand sufficient drug supplies to <unk>.
Speaker Change: Support our planned development activities for both the formulations with sub Q in the oral and.
Speaker Change: In the meantime, as we proceed forward we continue to have dialogue with the <unk>.
Speaker Change: Key global peptide suppliers and are working toward long term supply agreements and we are confident that we will be in a position.
To the supply of blockbuster size product at the appropriate time.
Speaker Change: Excellent. Thank you Brian Thats helpful on that.
Thanks Roger.
Speaker Change: The next question comes from Jay Olson with Oppenheimer. Please go ahead.
Jay Olson: Oh, Hey, thanks for this update and congrats on all the progress can you.
Jay Olson: Comment on what level of safety and Tolerability, you would like to see for the 100 milligram dose that might enable testing higher oral doses in the phase II study.
Jay Olson: Yes.
Speaker Change: We leave the tolerability decisions up to the dose level review team.
Speaker Change: That means after completion of every cohort and there was never a recommendation.
Speaker Change: From from that team to discontinue escalation, so we feel very comfortable with the.
Speaker Change: With the Tolerability profile.
Speaker Change: Okay, great. Thank you and then recognizing that our commercial launches years away you recently indicated that a synthetic manufacturing.
Speaker Change: External supplier could be outlined by the end of the year could you. Please comment on how those discussions are going and any other updates on the manufacturing front.
Speaker Change: Yes, yes, thanks Jay.
Speaker Change: So as I mentioned a minute ago, we do continue to have dialogue with global peptide suppliers, who can scale up and.
Speaker Change: Some of that discussion is focused on various synthetic route. So all of that is in progress and under active development. So when we make decision for the route that will be utilized for scale up.
Speaker Change: We will talk more about it but all of that is still in process as we speak.
Okay, Great and maybe one big picture question as you think about the total value for VK. Two 735 can you just talk about how that value is split between this Q and oral forms.
Speaker Change: Yes, it's an interesting question and oftentimes it depends on who you ask we view the.
Really anchor piece to the franchises.
Speaker Change: The subcutaneous formulation with the oral being a very nice add on but unlikely to be the the major modality and when you look at the utilization right now, we're probably going to exceed the $40 billion in total revenue from the current obesity.
Speaker Change: Drugs and so.
Those are rapidly expanding and we will continue to do so.
Speaker Change: In the absence of an oral which is some time off so.
Speaker Change: To think an oral would come in and dominate.
Speaker Change: Don't know how likely that is we see the oral is probably.
Speaker Change: 20% opportunity in the Injectables, probably an 80% opportunity.
Speaker Change: Great Super helpful. Thanks for taking all the questions.
Speaker Change: Thanks Jay.
Speaker Change: The next question comes from Justin <unk> with BTG. Please go ahead.
Speaker Change: Thanks for taking our questions and congrats on the progress Brian on the sub Q injectable.
Justin <unk>: The phase III coming up would you look to use an auto injector format for that study or can you talk to us about.
Justin <unk>: If youre looking at a transition to an auto injector, what that might entail whether you would need a separate study for that and I have a follow up thanks.
Speaker Change: Yeah. Thanks, Justin So we haven't talked much about the trial design, but we will be using a an auto injector in that study. If it's available soon enough we would utilize that from the onset of the study if not we would seek to transition people from violin syringe to the auto injector.
Speaker Change: Okay, great. So it sounds like you might be in discussions with securing some of the auto injector materials in order to prepare for that.
Speaker Change: Oh, yes, yes, that's right.
Speaker Change: Okay excellent and then just a question on the X E L D.
Speaker Change: Remembering correctly the FTA considered the recent study to be a phase II study what would that mean that if youre looking to progress that into clinical development. The next step would be a like a registrational study.
Speaker Change: Yes. Good question, that's what we think.
Speaker Change: Typically you look at these biomarker studies initially in this indication anyway, and then proceed to a registration study, whether it's phase two or three or a phase III.
Speaker Change: So that would be our expectation here as well likely focused on.
Speaker Change: More of a functional or quality of life endpoint not just the very long chain fatty acids, that's been the historical path forward in <unk>.
Speaker Change: Great well, thanks for taking my questions.
Speaker Change: Thanks, Justin.
Speaker Change: Again, if you have a question. Please press Star then one.
The next question comes from Thomas Smith with Leerink Partners. Please go ahead.
Thomas Smith: Hey, guys. Good afternoon, thanks for the update and for taking the questions first on oral and 2735 looking forward, particularly in the data at obesity week.
Speaker Change: Brian I just wanted to follow up on an earlier question and I know you commented back in September that the dose level Review Committee.
Speaker Change: Yet to review the data from the 100 Meg cohort I was wondering if you could just comment on whether the net at this point and clarify whether there is still any potential or desire to explore a higher dose level here in the phase one setting our business something you may consider doing and the things too.
Speaker Change: Yes.
Speaker Change: So getting to the root of the question would we dose higher.
Speaker Change: I think it's certainly possible to dose higher.
Speaker Change: And.
Speaker Change: I guess, we would really disclose that when we start the phase II study there was nothing in the.
Speaker Change: Initial.
Speaker Change: Read of the data that would indicate.
Speaker Change: We'd be precluded from dosing up but.
Speaker Change: We'd rather.
Speaker Change: Refrain any further comment until we present the actual data at the obesity week conference.
Speaker Change: Got it okay that makes sense.
Speaker Change: And then for maybe a quick question on 28 and on in.
Speaker Change: In Nash.
Speaker Change: And looking forward to the late breaking data there to a faulty can you maybe tease.
Speaker Change: The additional data and analysis, we can look forward to seeing.
Speaker Change: At the liver meeting and then.
Speaker Change: Any update on how you're thinking strategically about next steps with that program, perhaps with respect to engaging partners.
Speaker Change: Yeah, Thanks, Tom we'll certainly.
Speaker Change: Look at the histologic changes I think thats. The thing most people are interested in changes in fibrosis any differences in response, among the various severities of fibrosis.
Speaker Change: <unk> differences in response, depending on baseline characteristics with liver fat as well so that would be sort of I think.
Speaker Change: Of interest to to look at.
Speaker Change: Next steps here, we've always felt that the.
Speaker Change: The Nash program would be.
Speaker Change: Best handled in conjunction with the.
With a larger pharma collaborator and Thats the way, we still feel about it so.
Speaker Change: We'll review the responses we received from the FDA and proceed from there.
Speaker Change: Got it alright, thanks for taking the questions guys I appreciate it.
Speaker Change: Thanks, Tom.
Speaker Change: The next question.
Speaker Change: <unk> comes from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Yale Jen: Thanks for taking the question and congrats on the progress just two here. The first one is in terms of our 21 night, you've got FDA feedback and now you are reviewing it just curious any surprises.
Yale Jen: What's your expectation and would that impact anything on the potential partnering.
Yale Jen: You may have.
Yale Jen: And then I have one I think.
Yeah no good question.
Speaker Change: <unk> received those.
Speaker Change: Responses.
Speaker Change: Within the last 48 hours and we're we're reviewing them.
Speaker Change: No real surprises or or unexpected.
Speaker Change: Comments in them.
Speaker Change: Thus far.
Speaker Change: So it's still in process of looking at them.
Speaker Change: Okay, Great and maybe just one more.
Speaker Change: Follow up here, which is that.
Speaker Change: The reason I.
Speaker Change: Steve meeting, there's a lot of talk about the Avalon as well.
Speaker Change: Fine.
Speaker Change: One study readout could be available in the fourth quarter and this year, what do you think the potential readouts or impact you might have on your program or are you guys thinking about the design and whatnot. So any color there. Thanks.
Speaker Change: Well, yes, we think the mechanism is really exciting and.
Speaker Change: When you think about the effect on appetite and feeding behavior.
Speaker Change: It seems to act in a V.
Speaker Change: We're a different mechanism than <unk> in CIP. So.
Speaker Change: You should see a nice add on effect.
Speaker Change: So I would expect to see exciting data.
Speaker Change: When it's reported later this year and I think that would bode well for our own program. If we're able to combine it successfully with the.
Speaker Change: With VK 275, or other things in the pipeline so.
Speaker Change: So far what we've seen for Hamlin looks.
Speaker Change: Looks really promising and thats one of the reasons, we're excited about it.
Speaker Change: Okay, great. Thanks, a lot and congrats again.
Speaker Change: Thanks Neil.
Speaker Change: The next question comes from <unk> Parikh with Jpmorgan. Please go ahead.
Speaker Change: Hey, Brian just wanted to ask you.
Speaker Change: First question is just a clarification I just wanted to make sure in the phase one trial.
Speaker Change: Have you have or you have not tested doses above.
Speaker Change: 100 milligrams in the oral oral format and then the second one is just more of a high level question. I think we saw a number of kind of competitive readout in obesity for example at USD and just wanted to get your overall thoughts on.
Speaker Change: What you learned out of those data readouts from Novo and Roche and and so forth. Thank you.
Speaker Change: Yes, Thanks Charlie.
Speaker Change: We went up in the oral and the subsequent cohorts were 60 milligrams 80 milligrams and 100 milligrams.
Speaker Change: And.
Speaker Change: Yes, like I said earlier, we'll have we'll have the data.
In about a week and a half.
Speaker Change: With respect to ASD.
Speaker Change: A lot of really interesting programs in the space is really really hot right now.
Speaker Change: So, but I guess what was.
Speaker Change: I think comforting to us is that we do feel like we have.
Speaker Change: Two of the best programs.
Speaker Change: With respect to motive delivery, the injectable and the oral.
Speaker Change: And so there was nothing.
Speaker Change: At the conference that would lead us to believe otherwise.
Speaker Change: Everything is still pretty early right now, but I think we feel good coming out of both the Ada and disd about.
Speaker Change: Value of the pipeline today, and we're looking forward to the subsequent studies with both.
Speaker Change: With both the formulations of VK 275, and with the Amylin program.
Speaker Change: Thank you.
Speaker Change: Thanks Kartik.
Speaker Change: The next question comes from Alex Ramsey with William Blair. Please go ahead.
Hi, Brian Thanks, so much for taking my questions.
Alex Ramsey: If you don't mind, if I can ask a month's time.
Speaker Change: So our first question is about the maintenance opportunity for Teekay <unk> Hi.
Clean, but curious about how you think about the dosing in this setting and really more from a philosophical standpoint.
Speaker Change: So just to provide a little more contacts. The question is driven by the observation that in the weight loss setting. The goal is to stimulate kumar deficit, but debenhams, so different than maintenance and English goldfarb outstanding equilibrium.
Speaker Change: We're just wondering how you think about adjusting that sending in my question. The key questions that youre asking how are you designing experiments to address those questions around dosing.
Speaker Change: Yes, Thanks, Alex.
Speaker Change: The monthly regimen, we view it as really more of a maintenance regimen. Then then a weight loss regimen.
And so it would be an option for someone who is.
Speaker Change: Reached their target range and weight to transition from the weekly to a monthly and really keep their weight sustained possibly to continue further downward, but really our thought would be the most likely.
Speaker Change: Use would be in the maintenance setting so just furthers the convenience aspect of the.
Speaker Change: The compound or the mechanism.
Speaker Change: Was there a second part to that question.
Speaker Change: Yes, no that makes sense. So that's just.
Speaker Change: Just looking like longer dosing intervals.
Speaker Change: The needs for a mechanism for driving that difference between equilibrium versus stimulating continuous Clark deficit.
Speaker Change: Yeah.
Speaker Change: It's kind of a little bit of both.
Speaker Change: You're right.
Speaker Change: Re equilibrate, maybe at a lower caloric intake.
Speaker Change: That's what the hope would be anyway.
Speaker Change: Okay. Thank you that makes sense.
Speaker Change: Perfect.
Speaker Change: Second question is in regards to the amylin asset so im just looking across the various investigational therapy.
Speaker Change: As in most companies seem to be gravitating towards that counsel Tony component that I mentioned earlier. So we're just curious about your views on top of tone in and I do think there is an optimal ratio in terms of agonism and if the answer is.
Speaker Change: And then also wondering however, with Teekay <unk> and then two small central agonists.
Forum's agnathan biased, but England program.
Speaker Change: Yeah.
Speaker Change: So historically I think the first compound was very heavily active on the amylin receptor and less so on the calcitonin receptor.
Speaker Change: Pramlintide was that compound more recently.
Speaker Change: <unk>.
Speaker Change: Most programs are.
Speaker Change: We are targeting both I don't know if thats intentional or it's just very difficult to tease away amlin from calcitonin.
<unk>.
Speaker Change: Have worked on compounds that target both and.
Speaker Change: It seems like the ones that have more of a balance on both receptors just show a slightly better weight loss profile than ones that skew one way or another.
Speaker Change: And so that's what has led us to the more balanced.
Speaker Change: Mechanism, but I don't know that its.
Speaker Change: Really well understood at least it isn't by me.
Speaker Change: What is the ideal ratio it just seems like the closer you get to one the better the profile seems to look overall.
Speaker Change: Okay, that's very interesting.
Speaker Change: Great. Thanks for taking my question.
Alex Ramsey: Thanks, Alex.
Speaker Change: This concludes our question and answer session I would 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.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: [music].
Speaker Change: Okay.