Q4 2024 Viking Therapeutics Inc Earnings Call

Welcome to the Viking Therapeutics fourth quarter and full year 2024 financial results Conference call. At this time all participants are in a listen only mode. Following management's prepared remarks, we will hold a question and answer.

Operator: Welcome to the Viking Therapeutics fourth quarter and full year 2024 financial results conference call. At this time, all participants are in a listen only mode.

Operator: Following management's prepared remarks, we will hold a question and answer session. To ask a question, you may press. the star key followed by the number one on your touchtone phone. If anyone has difficulty hearing the conference, please press star and then zero for operator assistance.

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To ask a question you May press star.

Starkey followed by the number one on your Touchtone phone.

Speaker Change: If anyone has difficulty hearing the conference. Please press Star and then zero for operator assistance as a reminder, this conference call is being recorded today February 5th 2025, I would now like to turn the conference over to Viking's manager of Investor Relations. Stephanie Diaz. Please go ahead.

Operator: As a reminder, this conference call is being recorded today, February 5th, 2025.

Stephanie Diaz: I would now like to turn the conference over to Vikings Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie. Hello, and thank you all for participating in today's call.

Stephanie Diaz: Stephanie Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's, President and CEO and Greg Zante Viking's CFO before we begin I'd like to caution that comments made during this conference call. Today February 15, 2025 will contain forward looking statements under the safe Harbor.

Stephanie Diaz: Joining me today is Brian Lian, Vikings President and CEO, and Greg Zante, Vikings CFO. Before we begin, I'd like to caution that comments made during this conference call today, February 5th, 2025, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Vikings expectations regarding its development activities, timelines, and milestones. Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today.

Stephanie Diaz: Provisions of the U S. Private Securities Litigation Reform Act of 1995, including statements about <unk> expectations regarding its development activities 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. 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.

Stephanie Diaz: I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

Stephanie Diaz: Courage, yet or if you all of the company's filings with 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: I'll now turn the call over to Brian Lian for his initial comment. Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the three months and full year ended December 31st, 2024, and provide an update on recent progress with our development programs and operations. 2024 was an exceptionally busy year for Viking. During the year, the company reported successful results from four different studies across our pipeline. These include the announcement of positive data from our VK2735 subcutaneous program for obesity, the results of our VK2735 oral tablet program for obesity, the histology results from our VK2809 program for the treatment of MASH and fibrosis, and the initial proof of concept data from our VK0214 program for XALD.

Brian Lian: Thanks, Stephanie and good afternoon to everyone listening in by phone or on the webcast today will review our financial results for the three months and full year ended December 31, 2024, and provide an update on recent progress with our development programs and operations.

Brian Lian: 2024 was an exceptionally busy year for Viking during the year. The company reported successful results from four different studies across our pipeline.

Brian Lian: These include the announcement of positive data from our VK two 735 subcutaneous program for obesity. The results of our vacate 275 oral tablet program for obesity.

Brian Lian: The histology results from our vacate two eight or nine program for the treatment of mash in fibrosis and the initial proof of concept data from our <unk> program for X L D.

Brian Lian: With respect to VK2735, our lead program for obesity, in the first quarter of 2024, we announced positive results from the Phase 2 Venture Trial evaluating subcutaneous administration in obese subjects. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment. Later in the first quarter, we announced the initial results from a 28-day Phase I trial evaluating an oral-tablet formulation of VK2735, which demonstrated excellent tolerability and encouraging reductions in body weight. In the second quarter of 2024, we announced histology results from the Phase 2b VOYAGE trial evaluating our novel thyroid hormone receptor beta-agonist, VK2809, for the treatment of MASH and fibrosis.

Brian Lian: With respect to VK two 735, our lead program for obesity in the first quarter of 2024, we announced positive results from the phase II venture trial evaluating subcutaneous administration in obese subjects.

Brian Lian: This trial demonstrated impressive reductions in body weight after 13 weeks of treatment.

Brian Lian: Later in the first quarter, we announced the initial results from a 28 day phase one trial evaluating an oral tablet formulation of VK, two 735, which demonstrated excellent tolerability and encouraging reductions in body weight.

Brian Lian: In the second quarter of 2024, we announced histology results from the phase <unk> voyage trial evaluating our novel thyroid hormone receptor beta agonist VK, two eight or nine for the treatment of mashing fibrosis.

Brian Lian: This study successfully achieved its primary, secondary, and exploratory endpoints, showing reductions in liver fat at 12 weeks, and improvements in MASH resolution rate and fibrosis after 52 weeks. And finally, in the fourth quarter of 2024, the company announced positive results from a 28-day phase 1B clinical trial of our second novel thyroid hormone receptor beta agonist, VKO214, in patients with X-linked adrenoleukodystrophy, or XALD. Results from this study showed VKO214 to be safe and well-tolerated, and treated patients demonstrated significant reductions in plasma levels of very long-chain fatty acids compared with placebo. During the year, the company also announced the addition of a new program to its pipeline focused on a series of internally developed agonists of the amylin receptor.

Brian Lian: This study successfully achieved its primary secondary and exploratory endpoints showing reductions in liver fat at 12 weeks and improvements in mass resolution rate and fibrosis after 52 weeks.

Brian Lian: And finally in the fourth quarter of 2024, the company announced positive results from a 28 day phase <unk> clinical trial of our second novel thyroid hormone receptor beta agonist <unk> four in patients with X linked Adrenoleukodystrophy or X L D.

Brian Lian: Results from this study showed <unk> to be safe and well tolerated and treated patients demonstrated significant reductions in plasma levels of very long chain fatty acids compared with placebo.

Brian Lian: During the year. The company also announced the addition of a new program to its pipeline focused on a series of internally developed agonist of the amylin receptor.

Brian Lian: In animal models, these compounds demonstrated improvements in body weight and metabolic profile. On the corporate side, during the first quarter of 2024, Viking closed a successful public offering of common stock, raising more than $630 million in gross proceeds, providing the resources to aggressively move forward with our pipeline program.

Brian Lian: In animal models. These compounds demonstrated improvements in body weight and metabolic profile.

Brian Lian: On the corporate side during the first quarter of 2020 for Viking closed a successful public offering of common stock raising more than $630 million in gross proceeds providing the resources to aggressively move forward with our pipeline programs.

Brian Lian: I'll have additional comments on our operations and development activities after we review our financial results for the fourth quarter and year ending December 31st.

Brian Lian: I'll have additional comments on our operations and development activities. After we review our financial results for the fourth quarter and year ending December 31.

Greg Zante: For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer. Thanks, Brian.

Brian Lian: With that I'll turn the call over to Greg Zante, Viking's, Chief Financial Officer.

Brian Lian: Thanks.

Greg Zante: In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the fourth quarter and full year ended December 31st, 2024, beginning with the quarter. Research and development expenses were $31 million for the three-month end of December 31, 2024, compared to $20.5 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, salaries and benefits, and stock-based compensation, partially offset by decreased expenses related to clinical and preclinical studies.

Brian Lian: Ryan.

Brian Lian: In conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file shortly.

Brian Lian: I'll now go over our results for the fourth quarter and full year ended December 31, 2024, beginning with the quarter.

Brian Lian: Research and development expenses were 31 million for the three months ended December 31, 2024, compared to $20 5 million for the same period in 2023.

Brian Lian: The increase was primarily due to increased expenses related to manufacturing for our drug candidates salaries and benefits and stock based compensation, partially offset by decreased expenses related to clinical and preclinical studies.

Greg Zante: General and administrative expenses were $15.3 million for the three months ended December 31, 2024, compared to $8.8 million for the same period in 2023. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, salaries and benefits, insurance, and professional fees. For the three months ended December 31st, 2024, Viking reported a net loss of $35.4 million, or $0.32 per share, compared to a net loss of $24.6 million, or $0.25 per share in the corresponding period of 2023. The increase in net loss for the three months ended December 31st, 2024, 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.

Brian Lian: General and administrative expenses were $15 3 million for the three months ended December 31 2024.

Brian Lian: Word to $8 8 million for the same period in 2023.

Brian Lian: The increase was primarily due to increased expenses related to legal and patent services stock based compensation salaries and benefits insurance and professional fees.

Brian Lian: For the three months ended December 31, 2020 for Viking reported a net loss of $35 4 million or <unk> 32 per share compared to a net loss of $24 6 million or 25 per share in the corresponding period of 2023.

Brian Lian: The increase in net loss for the three months ended December 31, 2024 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.

Brian Lian: I'll now go over our results for the full year ended December 31 2024.

Greg Zante: I'll now go over our results for the full year ended December 31st, 2024. Our research and development expenses for the year ended December 31st, 2024 were $101.6 million compared to $63.8 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, stock-based compensation, and salaries and benefits. partially upset by a decrease in expenses related to clinical and preclinical studies. Our general and administrative expenses for the year ended December 31st, 2024 were $49.3 million compared to $37 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional fees, insurance, and services provided by third-party consultants.

Brian Lian: Our research and development expenses for the year ended December 31, 2024, or $101 6 million compared to $63 8 million for the same period in 2023.

Brian Lian: The increase was primarily due to increased expenses related to manufacturing for our drug candidates stock based compensation and salaries and benefits, partially offset by a decrease in expenses related to clinical and preclinical studies.

Brian Lian: Our general and administrative expenses for the year ended December 31, 2024 were $49 3 million compared to 37 million for the same period in 2023.

Brian Lian: The increase was primarily due to increased expenses related to stock based compensation salaries and benefits professional fees insurance and services provided by third party consultants, partially offset by decreased expenses related to legal and patent services.

Greg Zante: Partially upset by decreased expenses related to legal and patent services.

Greg Zante: The year ended December 31, 2024. Viking reported a net loss of $110 million, or $1.01 per share, compared to a net loss of $85.9 million, or $0.91 per share, in the corresponding period in 2022. The increase in net loss for the year ended December 31st, 2024, 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.

Brian Lian: For the year ended December 31, 2020 for Viking reported a net loss of $110 million or $1 <unk> per share compared to a net loss of $85 9 million or <unk> 91 per share in the corresponding period in 2023.

Brian Lian: The increase in net loss for the year ended December 31, 2024 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.

Brian Lian: Turning to the balance sheet at December 31, 2020 for Viking held cash cash equivalents and short term investments of $903 million compared to $362 million as of December 31, 2023.

Greg Zante: Turning to the balance sheet, at December 31st, 2024, Viking held cash, cash equivalents and short-term investments of $903 million, compared to $362 million as of December 31st, 2023.

Brian Lian: This concludes my financial review and I'll now turn the call back over to Brian.

Brian Lian: This concludes my financial review and I'll now turn the call back over to Brian.

Brian Lian: Thanks, Greg. I'll now provide a summary of clinical highlights from 2024 and outline next steps with our pipeline programs, starting with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor, and the glucose-dependent insulinotropic polypeptide, or GIP, receptor. The company's initial Phase I single and multiple ascending dose trial for VK2735 demonstrated the promising safety, tolerability, and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection for up to four weeks. Subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau.

Brian Lian: Thanks, Greg.

Brian Lian: I will now provide a summary of clinical highlights from 2024 and outline next steps with our pipeline programs, starting with our lead obesity program VK $2 75.

Brian Lian: VK two 735 is a dual agonist of the glucagon like peptide one or G. L. P. One receptor and the glucose dependent insulinotropic polypeptide or G IP receptor.

Brian Lian: The Companys initial phase one single and multiple ascending dose trial for VK, two 785, demonstrating the promising safety Tolerability and pharmacokinetics of VK two 735, when administered as a weekly subcutaneous injection for up to four weeks subs.

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 initiated a phase II study called the venture study to evaluate longer term dosing with VK two 735 in subjects with obesity.

Brian Lian: Following these results, the company initiated a Phase 2 study called the Venture Study to evaluate longer-term dosing with VK2735 in subjects with obesity. This trial was a randomized, double-blind, placebo-controlled, multi-center study that evaluated the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 administered subcutaneously once weekly for 13 weeks. In the first quarter of 2024, the company announced positive results from the venture trial, which successfully achieved its primary and secondary end. The study demonstrated that patients receiving VK2735 achieved statistically significant reductions in mean body weight from baseline, ranging up to 14.7%. The Venture study also showed VK2735 to be safe and well-tolerated through 13 weeks of dosing, with the majority of treatment-emergent adverse events characterized as mild or moderate.

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 275 administered subcutaneously once weekly for 13 weeks in.

Brian Lian: In the first quarter of 2024, the company announced positive results from the venture trial, which successfully achieved its primary and secondary endpoints.

Brian Lian: The study demonstrated that patients receiving VK two 705 achieve statistically significant reductions in mean body weight from baseline ranging up to 14, 7%.

Brian Lian: The venture study also showed VK 275 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment emergent adverse events characterized as mild or moderate.

Brian Lian: Adverse events generally occurred early in the course of treatment and were primarily related to the expected GI effects resulting from activation of the GLP-1 receptor. These data were presented last November at Obesity Week, the annual meeting of the Obesity Society. This presentation also provided updated results from follow-up visits that occurred four and seven weeks after the last dose of VK2735 was administered. These results showed that cohorts receiving VK2735 maintained the majority of their weight loss through the seven-week follow-up visit after administration of the final dose of VK2735. This included the 2.5 mg weekly dose, the lowest dose evaluated, for which over 90% of the initial weight loss was maintained seven weeks after the last dose was administered.

Brian Lian: Adverse events generally occurred early in the course of treatment and were primarily related to the expected Gi effects, resulting from activation of the G. L. P. One receptor.

Brian Lian: These data were presented last November at obesity week, the annual meeting of the obesity Society.

Brian Lian: This presentation also provided updated results from follow up visits that occur at four and seven weeks. After the last dose of VK two 735 was administered.

Brian Lian: These results showed that cohorts receiving VK two 735 maintain the majority of their weight loss through the seven week follow up visit after administration of the final dose the Dk 275.

Brian Lian: This included the $2 five milligram weekly dose the lowest dose evaluated for which over 90% of the initial weight loss was maintained seven weeks. After the last dose was administered.

Brian Lian: In a subset of participants, an evaluation of plasma levels of VK2735 at various time points following the 13-week dosing period was also conducted. We believe these pharmacokinetic results provide support for the feasibility of once-monthly dosing in the maintenance setting, and we plan to further evaluate monthly dosing later this year. Following completion of the Venture Study, Viking requested and was granted a Type C meeting with the FDA to discuss next steps for the program. Based on written feedback from this meeting, we advanced VK2735 into Phase 3 development for obesity. To this end, in the fourth quarter of 2024, we completed the successful end of phase two meeting with the agency, which was extremely helpful in informing our next steps and the phase three plan for the program.

Brian Lian: In a subset of participants and evaluation of plasma levels of VK two 735 at various time points. Following the 13 week dosing period was also conducted.

Brian Lian: We believe these pharmacokinetic results provide support for the feasibility of once monthly dosing in the maintenance setting and we plan to further evaluate monthly dosing later this year.

Brian Lian: Following completion of the venture study Viking requested and was granted a type C meeting with the FDA to discuss next steps for the program.

Brian Lian: Based on written feedback from this meeting we advanced VK, two 735 into phase III development for obesity.

Brian Lian: To this end in the fourth quarter of 2024, we completed a successful end of phase II meeting with the agency, which was extremely helpful. In informing our next steps and the phase III plan for the program.

Brian Lian: We currently expect to initiate Phase III trials evaluating subcutaneous VK2735 for the treatment of obesity in the second quarter of 2025. Also in 2024, we completed a Phase I study to evaluate an oral-tablet formulation of VK2734. The company believes a tablet formulation could represent an attractive treatment option for those who may be hesitant to initiate injection-based therapy or for those seeking to maintain the weight loss they have already achieved. An important differentiating advantage of a tablet formulation of VK2735 is the potential to transition patients from the subcutaneous formulation to an oral formulation which utilizes the same molecule.

Brian Lian: We currently expect to initiate phase III trials evaluating subcutaneous VK two 735 for the treatment of obesity and the second quarter of 2025.

Brian Lian: Also in 2024, we completed a phase one study to evaluate an oral tablet formulation of VK two 735.

Brian Lian: The company believes a tablet formulation could represent an attractive treatment option for those who may be hesitant to initiate injection based therapy or for those seeking to maintain the weight loss they have already achieved.

Brian Lian: An important differentiating advantage of a tablet formulation of VK. Two 735 has the potential to transition patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule.

Brian Lian: Viking believes this may reduce the risk of unexpected safety or tolerability challenges and could be a valued option for both patients and clinicians. Our Phase I study was a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days. Secondary and exploratory objectives included an evaluation of the pharmacokinetics of oral DK2735, as well as changes in body weight and other metrics. The results of this study were presented at the Obesity Week conference last November.

Brian Lian: Viking believes this may reduce the risk of unexpected safety or tolerability challenges and could be a valued option for both patients and clinicians.

Our 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 square.

Brian Lian: The primary objective of the study was to evaluate the safety and Tolerability of VK two 785 administered as a tablet once daily for 28 days.

Brian Lian: Secondary and exploratory objectives include an evaluation of the pharmacokinetics of oral <unk> hundred 75, as well as changes in body weight and other metrics.

Brian Lian: The results of this study were presented at the Ob Obesity week Conference last November.

Brian Lian: This presentation highlighted data showing that cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 days. Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day 57, four weeks after the last dose was administered. Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond 28 days may provide further reductions in body weight. Oral VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 mg. The majority of observed treatment-emergent adverse events were mild or moderate, with most reported as mild.

Brian Lian: This presentation highlighted data showing that cohorts receiving VK two 735 demonstrated dose dependent reductions in mean body weight from baseline ranging up to eight 2% after 28 days.

Brian Lian: Persistent weight loss effects of up to eight 3% from baseline were observed at follow up visits through day 57, four weeks after the last dose was administered.

Brian Lian: Based on our preliminary evaluation of weight loss trajectories.

Brian Lian: The company believes that continued treatment beyond 28 days may provide further reductions in body weight.

Brian Lian: Oral VK 2735 also demonstrated encouraging safety and Tolerability through 28 days of once daily dosing at doses up to and including 100 milligrams.

Brian Lian: The majority of the observed treatment emergent adverse events were mild or moderate with most reported as mild Sim.

Brian Lian: Similarly, all gastrointestinal adverse events were reported as mild or moderate, with the majority reported as mild. Based on these results, Viking designed and recently initiated a Phase II trial called the Venture Oral Dosing Trial to evaluate longer-term dosing with the tablet formulation in subjects with obesity. The Venture Oral Dosing Trial is a randomized, double-blind, placebo-controlled, multi-center study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of BK2735 dosed as an oral tablet once daily for 13 weeks. The trial will enroll approximately 280 adults who are obese or adults who are overweight with at least one weight-related comorbid condition.

Brian Lian: Similarly, all gastrointestinal adverse events were reported as mild or moderate with the majority of reported this mild.

Brian Lian: Based on these results Viking designed and recently initiated a phase II trial called the venture oral dosing trial to evaluate longer term dosing with the tablet formulation in subjects with obesity.

Brian Lian: The venture oral dosing trial is a randomized double blind placebo controlled multicenter study designed to evaluate the safety Tolerability pharmacokinetics and weight loss efficacy of VK, two 705 dose as an oral tablet once daily for 13 weeks.

Brian Lian: The trial will enroll approximately 280 adults who are obese or adults who are overweight with at least one weight related comorbidities condition.

Brian Lian: Patients will be evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study will assess the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.

Brian Lian: Patients will be evenly randomized to one of six dosing arms or placebo.

Brian Lian: The primary endpoint of the study will assess the percent change in body weight from baseline after 13 weeks of treatment.

Brian Lian: Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.

Brian Lian: We are pleased to have the venture oral dosing trial underway and we expect to report data from this study in the second half of 2025.

Brian Lian: We are pleased to have the Venture Oral Dosing Trial underway and we expect to report data from this study in the second half of 2025.

Brian Lian: Turning to our other metabolic programs I'll provide a brief update on our mash and rare disease programs, starting with our VK two eight or nine program.

Brian Lian: Turning to our other metabolic programs, I'll provide a brief update on our MASH and rare disease programs, starting with our VK2809 program. VK-2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta isoform of the receptor. In 2024, we announced final data from a 52-week study of DK2809 in patients with biopsy-confirmed MASH and fibrosis. This study, called VOYAGE, evaluated as a primary endpoint the change in liver fat following 12 weeks of once-daily treatment with VK2809. Secondary endpoints included assessments of histologic changes following 52 weeks of treatment.

Brian Lian: VK Twitter nine is an 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: In 2024, we announced final data from a 52 week study of VK, two eight or nine in patients with biopsy confirmed Nash and fibrosis.

Brian Lian: This study called voyage evaluated as a primary endpoint the change in liver fat following 12 weeks of once daily treatment with VK to Illinois.

Brian Lian: Secondary endpoints included assessments of histologic changes following 52 weeks of treatment.

Brian Lian: In 2023, we reported that the study had successfully achieved its primary endpoint, with patients who received VK2809 demonstrating statistically significant mean reductions in liver fat from baseline to week 12, as compared with placebo. In June of 2024, Viking announced the successful achievement of the trial's secondary endpoints, with VK2809-treated patients demonstrating statistically significant and best-in-class improvements in mass resolution rate, fibrosis stage, and the combination endpoint of mass resolution and fibrosis improvement compared with placebo. The final results from the VOYAGE study were presented last November in an oral late-breaker presentation at the annual meeting of the American Association for the Study of Literacy.

Brian Lian: In 2023, we reported that the study has successfully achieved its primary endpoint with patients who received VK two eight or nine demonstrating statistically significant mean reductions in liver fat from baseline to week 12, as compared with placebo.

Brian Lian: In June of 2024, Viking announced the successful achievement of the trial secondary end points with VK 289 treated patients demonstrated statistically significant and best in class improvements in mass resolution rate fibrosis stage, and the combination endpoint of mass resolution and fibrosis improvement compared with placebo.

Brian Lian: The final results from the voyage study were presented last November in an oral late breaker presentation at the annual meeting of the American Association for the study of liver disease.

Brian Lian: In the fourth quarter of 2024, we completed an end-to-phase 2 meeting with the FDA to discuss the next steps for VK2809 in MASH. Feedback from this meeting was helpful in outlining the future clinical paths for this program and we remain interested in exploring partnering opportunities for further development.

Brian Lian: In the fourth quarter of 2024.

Brian Lian: We completed an end of phase two meeting with the FDA to discuss the next steps for VK two it online and mash.

Brian Lian: Feedback from this meeting was helpful and outlining the future clinical path for this program and we remain interested in exploring partnering opportunities for further development.

Brian Lian: Turning to our fourth clinical program in October 2024, we reported positive results from a 28 28 day phase <unk> study 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: Turning to our fourth clinical program, in October 2024, we reported positive results from a 28-day Phase 1B study of our small molecule drug candidate VKO214 in patients with the rare neuromuscular disorder called X-linked adrenoleukodystrophy, or XALD. Like VK2809, VK0214 is also an orally available small molecule that is selected for the beta isoform of the thyroid hormone receptor. XALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a paroxysomal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolize these acids, and their accumulation is believed to contribute to the onset and progression of XALD.

Brian Lian: Like VK, two eight or nine D. K 0214 is also an orally available small molecule that is selective for the beta isoform of the thyroid hormone receptor.

Brian Lian: X L. D is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a proximal 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: Activation of the thyroid hormone receptor beta has been shown to increase the expression of an important compensatory transporter, very long-chain fatty acid. leading to improved metabolism and clearance of these compounds. Our Phase 1b trial was a multi-centered, randomized, double-blind, placebo-controlled international study in men with the adrenomyeloneuropathy, or AMN, form of exhale. The study enrolled patients across three cohorts, placebo and VK-0214 doses of 20 mg and 40 mg daily. The primary objectives were to evaluate the safety and tolerability of VKO-214 in subjects with AMN. An exploratory objective was to evaluate the effects of VKO-214 on plasma levels of very long-chain fatty acids.

Brian Lian: Activation of the thyroid hormone receptor beta has been shown to increase the expression of an important compensatory transporter very long chain fatty acids, leading to improved metabolism and clearance of these compounds.

Brian Lian: Our phase <unk> trial was a multicenter randomized double blind placebo controlled international study in men with the adrenal myelin neuropathy or <unk> form of <unk>.

Brian Lian: The study enrolled patients across three cohorts placebo and VK 0214 doses of 20 milligrams and 40 milligrams daily.

Brian Lian: The primary objectives were to evaluate the safety and Tolerability of <unk>, one four 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.

Brian Lian: The data from this study showed that treatment with VKO-214 resulted in statistically significant reductions in mean plasma levels of very long-chain fatty acids at both the 20-mg and 40-mg doses compared to placebo. Plasma levels of the important 26-carbon very long-chain fatty acid were reduced by approximately 38% relative to placebo after four weeks of once-daily dosing. In addition, subjects who received VKO-214 experienced reductions in other important plasma levels. Mean reductions relative to baseline and placebo were observed for LDL cholesterol, apolipoprotein B, and lipoprotein A. Importantly, VKO-214 also demonstrated encouraging safety and tolerability with treatment of emergent adverse events generally reported as mild to moderate.

Brian Lian: The data from this study showed that treatment with <unk> resulted in statistically significant reductions in mean plasma levels of very long chain fatty acids, and both 20 milligram and 40 milligram doses compared to placebo.

Brian Lian: Plasma levels of the important 26 carbon very long chain fatty acid will reduce by approximately 38% relative to placebo. After four weeks of once daily dosing.

Brian Lian: In addition, subject to receive <unk> experienced reductions in other important plasma lipids.

Brian Lian: Mean reductions relative to baseline and placebo were observed for LDL cholesterol April LIFO protein b.

Brian Lian: And LIFO protein a.

Brian Lian: Importantly, <unk> also demonstrated an encouraging safety and tolerability with treatment emergent adverse events generally reported as mild to moderate.

Brian Lian: As there is currently no pharmacologic treatment available for XALD, we are very pleased to achieve these first-in-class results and will look to partner this important program with an organization that has the appropriate expertise in rare disorders.

Brian Lian: As there is currently no pharmacologic treatment available for <unk>, we're very pleased to achieve these first in class results and we'll look to partner. This important program with an organization that has the appropriate expertise in rare disorders.

Finally in June of 2024 at the annual meeting of the American Diabetes Association, we announced data from a new program targeting novel <unk> agonist of the amylin receptor for the potential treatment of obesity.

Brian Lian: Finally, in June of 2024, at the annual meeting of the American Diabetes Association, we announced data from a new program targeting novel agonists of the amylin receptor for the potential treatment of obesity. We are pleased with the progress made to date with this program, and we expect to file an IND and initiate a Phase I clinical trial later this year.

Brian Lian: We are pleased with the progress made to date with this program and we expect to file an IND and initiate a phase one clinical trial later this year.

Brian Lian: Moving to corporate and financial matters as Greg discussed in his comments, we completed 2024 with a strong balance sheet and over $900 million in cash.

Brian Lian: Moving to corporate and financial matters, as Greg discussed in his comments, we completed 2024 with a strong balance sheet and over $900 million in cash. This provides us with the runway to complete Phase 3 trials for the VK2735 Obesity Program, as well as aggressively pursue clinical development with our other programs. In conclusion, 2024 was a year of exciting clinical successes at Viking. We begin 2025 in a strong position with more valuable clinical assets than at any time in Vikings history, and we are confident in our position for future success. Going forward, the company will prioritize our VK2735 program and we are happy to be advancing both the subcutaneous and oral formulations of this compound in the clinic.

Brian Lian: This provides us with the runway to complete phase III trials for the V. K, two 735 obesity program as well as aggressively pursue clinical development with our other programs.

Brian Lian: In conclusion 2024 was a year of exciting clinical successes at Viking. We begin 2025 in a strong position with more valuable clinical assets than at anytime in the Vikings history, and we are confident in our position for future success.

Brian Lian: Going forward the company will prioritize our VK two 735 program and we are happy to be advancing both the subcutaneous and oral formulations of this compound in the clinic.

Brian Lian: We plan to initiate Phase III trials with the subcutaneous formulation in the second quarter, and we expect to report data from the ongoing Phase II Venture Oral Dosing trial in the second half of the year. In addition, we plan to file an IND for our novel amylin agonist program later this year and look forward to moving this program into clinical development. Based on our strong financial position, we plan to continue an aggressive development pace with each of these programs. We look forward to providing further updates in the month ahead.

Brian Lian: We plan to initiate phase III trials with the subcutaneous formulation in the second quarter and we expect to report data from the ongoing phase II venture oral dosing trial in the second half of the year.

Brian Lian: In addition, we plan to file an IND for our novel Amylin agonist program later this year and look forward to moving this program into clinical development.

Brian Lian: Based on our strong financial position, we plan to continue an aggressive development pace with each of these programs.

Brian Lian: We look forward to providing further updates in the months ahead.

Brian Lian: This concludes our prepared comments for today.

Brian Lian: This concludes our prepared comments for today.

Operator: Thanks very much for joining us, and we'll now open the call for questions. Operator? We will now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two.

Brian Lian: 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 Touchtone phone.

Speaker Change: If youre using a speakerphone please pick up your handset before pressing the keys if at any time. Your question has been addressed and you would like to withdraw. Your question. Please press Star and then two our first question comes from Ryan that Shneur with Raymond James. Please go ahead.

Ryan Betchner: Our first question comes from Ryan Betchner with Raymond James. Please go ahead. Thank you very much for the question.

And then thank you very much for the question.

Ryan Betchner: I wanted to see if I could get some more detail from the discussion, from the feedback at the end of Phase 2 meeting, particularly details on the potential number, size, or maybe even potential comparator arms for the Phase 3 studies that you plan to initiate next quarter. Thank you.

Ryan Shneur: And wanted to see if I could get some more detail from the discussion the feedback.

Ryan Shneur: In the phase II meeting, particularly details on the potential number of sides or maybe even potential comparator arms for the phase III studies that you plan to initiate next quarter. Thank you.

Brian Lian: Yeah. Thanks Ryan.

Brian Lian: Yeah. Thanks, Ryan.

Brian Lian: We'll provide more detail on the study design when we announce the initiation, but the size would certainly conform to guidance, which requires at least 4,500 people in the Phase 3 program. For these two studies, there will be one in obese subjects and one in obese subjects with type 2 diabetes. We would plan to use multiple doses and conform in that we would target a 52-week treatment window as well. But we'll provide further details on the doses and other items when the trial is initiated.

Brian Lian: We'll provide more detail on the study design, when we announced the initiation but.

Speaker Change: The site is wood.

Speaker Change: Conform to guidance, which requires at least 4500 people in the phase III program.

Speaker Change: For these two studies there will be one in obese subjects and one in obese subjects with type two diabetes.

Speaker Change: <unk>.

Speaker Change: We would.

Speaker Change: We plan to use multiple doses.

Speaker Change: And.

Speaker Change: Conform that we would target a 52 week treatment window as well.

Speaker Change: But we will provide further details on the doses.

Speaker Change: Other items when the trials initiate.

Ryan Betchner: Got it.

Brian Lian: Got it thank you very much Brian.

Ryan Betchner: Thank you very much, Brian.

Mike Ulz: Thanks Ryan and the next question comes from Mike Ulz with Morgan Stanley please go ahead. Good afternoon and thanks for taking the question. Maybe just on the phase 3 obesity study, it looks like you narrowed the timing for the start there to 2q versus first half 25. Previously, just curious, you know, what The rationale for that and kind of the remaining steps to getting that study going.

Thanks Ryan.

Speaker Change: And the next question comes from Mike <unk> with Morgan Stanley. Please go ahead.

Mike: Good afternoon, and thanks for taking the question maybe just on the phase III obesity study it looks like you've narrowed the timing for the start there to <unk> versus first half 'twenty. Five previously just just curious you know what.

Mike: The rationale for that and kind of the remaining steps to getting that study going thanks.

Brian Lian: Yeah, thanks, Mike. We're just, it's primarily logistical, making the, you know, formulation, making the drug product to enter into the study. So having better visibility on the timelines for production of the clinical material allows us to focus the time, the window a little bit better. But everything's going according to plan, so nothing, no issues, just a, you know, big, complicated exercise, and we're well into it, though.

Speaker Change: Yeah. Thanks, Mike we're just it's primarily logistical.

Mike: Making the.

Mike: Formulation, making the drug product to enter into the study so.

Mike: Having better visibility on the timelines for production of the clinical material allows us to focus at the time the window, a little bit better, but everything is going according.

Mike: According to plan so nothing.

Mike: No no issues just to.

Mike: Big complicated exercise and we're well into it though.

Mike Ulz: Great. Thank you.

Speaker Change: Great. Thank you.

Mike Ulz: Thanks, Mike.

Mike.

Austin Rana: The next question comes from Joon Lee with Truist Securities. Please go ahead.

Speaker Change: The next question comes from Joon Lee with Truest Securities. Please go ahead.

Austin Rana: This is Austin Rana on for Joon Lee. Congrats on the quarter and thanks for taking the questions. Are these studies going to be standard weight loss studies or are you looking to include anything differentiating? And then how long do you think it'll take to recruit patients? And then I have a follow up.

Joon Lee: This is often run on from Joon Lee Congrats on the corner and thanks for taking the questions.

Joon Lee: Are these studies is going to be standard weight loss studies or are you looking to include anything differentiating.

Speaker Change: And then how long do you think it'll take to recruit patients and then I have a follow up.

Brian Lian: Yeah, sure. Well, the primary endpoint would be a change in body weight. You know, the diabetes study will also include glycemic endpoints, as you typically would in a type 2 diabetes study, but the primary endpoint would be a change in body weight.

Joon Lee: Yes sure.

Speaker Change: Well the primary endpoint.

Joon Lee: Would be change in body weight.

Joon Lee: The diabetes study will also include glycemic endpoints as you typically would in that.

Joon Lee: Type two diabetes study, but the primary endpoint would be.

Joon Lee: Change in body weight.

Joon Lee: I forgot the second question.

Austin Rana: I forgot the second part. Just how long it'll take to recruit patients. Oh, yeah.

Joon Lee: Just how long it'll take to recruit patients Oh, Yeah, Oh, yeah, we can't give guidance on that just yet.

Austin Rana: Oh, yeah, we can't give guidance on that just yet We you know, we need to start the study and understand timelines to site initiation as well as what the enrollment queue looks like but So we'll be able to provide that later, but can't can't prognosticate right now Okay, just one more. Are these studies starting concurrently? And have you secured an API for both of these three studies?

Joon Lee: We need to start the study and understand.

Joon Lee: Timelines to site initiation as well as what the enrollment Q looks like but yes.

Joon Lee: So it will be able to provide that later, but can't can't prognosticate right now.

Speaker Change: Okay. Just one more are these studies starting concurrently.

How do you secure the API for both phase III studies.

Brian Lian: Thank you.

Speaker Change: Thank you.

Brian Lian: Yeah, we do have the API for both studies, enough API to get through the Phase III program, and we do hope to start them as close as possible to concurrent as we can. Thank you.

Speaker Change: We do have the the API for both studies Napa API to get through the Phase III program, and we do hope to start them.

Speaker Change: As close as possible to concurrent is as we can.

Speaker Change: Thank you.

Speaker Change: Thanks, a lot.

Jay Olson: And the next question comes from Jay Olson with Oppenheimer. Please go ahead. Oh, hey, congrats on all the progress and thanks so much for taking the question. I think, Brian, you had mentioned that you were planning to test monthly for the sub-Q formulation later this year.

The next question comes from Jay Olson with Oppenheimer. Please go ahead.

Speaker Change: Oh, Hey, congrats on all the progress and thanks, so much for taking the question.

Speaker Change: I think Brian you had mentioned that you were planning to test month's lead us for the sub Q formulation. Later this year can you just talk about your thoughts on the study design and whether or not that can be implemented into phase III and eventually get into the label and then I had one.

Brian Lian: Can you just talk about your thoughts on the study design and whether or not that can be implemented into Phase 3 and eventually get into the label? And then I had one follow-up.

Speaker Change: Follow up if I could.

Brian Lian: Yeah, thanks, Jay.

Speaker Change: Yes, Thanks, Jay the long term goal would be to have something in the label whether or not it.

Brian Lian: The long term goal would be to have something in the label, whether or not it would be in the initial NDA, too early to tell right now. The study that we'd like to initiate will be a study where we rapidly titrate people to a high dose of VK2735, and then transition them from the weekly to the monthly cadence, and really look for weight regain. We're not anticipating further weight loss, but how does maintenance work at this less frequent dosing and Okay, great.

Speaker Change: It would be in the initial NDA.

Speaker Change: Too early to tell right now.

Speaker Change: <unk> that we'd like to initiate will be a study where we rapidly titrate people to a high dose of <unk>.

Speaker Change: <unk> thousand 735, and then transition them from the weekly to the monthly.

Speaker Change: Cadence and really look for.

Speaker Change: Wait regain how does.

Speaker Change: We're not anticipating further weight weight loss, but how does maintenance work at less frequent dosing interval.

Speaker Change: Okay, great. Thank you and then.

Brian Lian: Thank you. And then further along the lines of maintenance dosing, I think you mentioned there was an option to transition from sub-Q to the oral formulation. Is that something that you were planning to do in a separate study? Yeah, so ideally, this would be in the same study. So we would transition some to a low-dose oral. But we're working through the protocol currently.

Speaker Change: Further along the lines of maintenance dosing I think you mentioned there was an option to transition from sub Q to the oral formulation is that something that you were planning to do in a separate study.

Speaker Change: Yeah. So.

Speaker Change: Ideally this would be in the same study.

Speaker Change: So we would transition some too low dose oral but we're working through the protocol currently and the plan would be we do the first study is sort of a PK exploratory study and then followed up with a little bit longer term study to look at longer term maintenance effects.

Brian Lian: And the plan would be we do the first study as sort of a PK exploratory study, and then follow it up with a little bit longer-term study to look at longer-term maintenance. Okay, great.

Speaker Change: Okay, great. Thanks, that's super helpful. I appreciate you taking the questions.

Jay Olson: Thanks. That's super helpful.

Jay Olson: Appreciate taking the question. Thanks for watching.

Speaker Change: Thanks, a lot Jay.

Annabel Samimy: And the next question comes from Annabel Samimy with Stiefel. Please go ahead. Hi. Thanks for taking my question. Just a couple for me. For the Phase II oral Ventra trial, it looks like it's a pretty broad dose range still. And any reason why it's not more narrow and at the highest dose, is that something that you'll realistically be pursuing? Or are you still just testing the maximum tolerability again? Yeah, thanks, Annabel.

Speaker Change: And the next question comes from Annabel <unk> with Stifel. Please go ahead.

Annabel: Hi, Thanks for taking my question just a couple from me.

The phase two oral venture trial, it looks like it's a pretty broad dose range still and any reason why it's not more narrow and at the highest dose is that something that you'll you'll realistically be pursuing or you're still Jeff.

Annabel: Just testing the Maxim Tolerability again.

Speaker Change: Yes, Thanks Ed.

Annabel Samimy: TBD on what the dose range would be in a subsequent study, we're just getting this one underway. But we really want to know, when you treat for a longer period of time, do these lower doses continue to mature on body weight reduction? It looked like the lower doses did have that in the phase one study, but it was so short and so small that it's It does seem like as we get further accumulation with longer-term dosing, you should see this sort of maturing efficacy signal.

Speaker Change: TVD on what the dose range would be in a subsequent study where just given this one underway.

Speaker Change: But we really want to know when you treat for a longer period of time do these lower doses continue to mature.

Speaker Change: On the on body weight reduction it looked like the lower doses did have that in the phase one study, but it was so short and so small that it's up.

Speaker Change: Really hard to tell it does seem like as we get further accumulation with longer term dosing you should see this sort of maturing efficacy signal but.

Brian Lian: But we haven't done the study yet, so we'll see how it turns out. At the highest dose, are you comfortable that you've tested maximum tolerability, or are you just trying to push as broad a dose range as you can? Yeah, the phase one study was very well tolerated at 100. We pushed a little bit higher here, and we were okay to do that. So could we go even higher? I don't know. We only proposed 120. I think we could probably defend higher doses, but we balanced that against what we know about the accumulation rate as being slow, and almost certainly we're not at steady state at 28 days, so it's a balance where you pick that top dose.

Speaker Change: We.

Speaker Change: Having done the study yet so we'll see how it turns out.

Speaker Change: Yes.

Speaker Change: And at the highest dose are you do you are you comfortable that you've tested maximum tolerability or you just.

Speaker Change: Yes.

Speaker Change: Trying to pushes has brought a dose ranging you can't.

Speaker Change: Yes.

Speaker Change: The phase one study was very well tolerated at 100.

Speaker Change: We pushed a little bit higher here and.

Speaker Change: And we were okay to do that so could we go even higher.

Speaker Change: No we only proposed a 120.

Speaker Change: We could probably defend higher doses, but we balance that against what we know about the accumulation rate as being slow and almost certainly we're not at steady state at 28 days so.

Speaker Change: It's a balance.

Brian Lian: But 120 seems to be an interesting dose to look at.

Speaker Change: Where you pick that top dose, but 120 seems to be a.

Speaker Change: It'll be an interesting dose to look at.

Brian Lian: Okay, and then just as a follow-up, any updates on the manufacturing agreement and why it might be taking so long to finalize? Yeah, spending a lot of time on on manufacturing. We, you know, continue to work toward a comprehensive agreement or set of agreements.

Okay, and then just as a follow up any updates on the manufacturing agreement and why it might be taking so long to finalize.

Speaker Change: Yes, spending a lot of time on manufacturing, we continue to work toward a com.

Speaker Change: Comprehensive.

Speaker Change: Agreement or a set of agreements.

Brian Lian: And the goal is really to enable the launch of a substantial commercial product. Complicated discussions, but making a lot of good progress and we'll have more to say at the appropriate time.

Speaker Change: And the goal is really to enable the launch of a substantial commercial product.

Speaker Change: Complicated discussions, but making a lot of good progress and we'll have more to say at the appropriate time.

Annabel Samimy: Thank you. Thanks Annabel.

Speaker Change: Thank you.

Annabel: Thanks Annabel.

Annabel: And the next question comes from Mani, Inc. Mom Penny with B Riley Securities. Please go ahead.

Monyink Mompanyi: And the next question comes from Monyink Mompanyi with B. Riley Securities. Please go ahead. Yes, good afternoon. Thanks for taking our questions and congrats on the operational progress. Just on the Venture Oral Phase 2 study, I appreciate the, you know, rationale for choice of top-dose selection there.

Annabel: Yes. Good afternoon, thanks for taking our questions and congrats on the operational progress.

Annabel: On the <unk> phase III study.

Annabel: I appreciate it.

Annabel: The rationale for choice of dog dose selection.

Brian Lian: Are you able to comment, Brian, on the 13-week weight loss expectation and if you could also help us think about the cost of goods sold based on the manufacturing contracts you're working on to secure the API would be helpful and then I have a Yeah, I'd say on both of those a little too early to tell. We can't really predict where the weight loss might land after 13 weeks. You know, when we look at the four-week graphs, you know, you can see the trends continuing downward, but where do those go from here? It's really hard to predict.

Brian Lian: The comment Brian on.

Brian Lian: The <unk> weight loss expectation and if you could also help us think about the cost of goods sold based on the manufacturing contracts youre working on to secure the API.

Brian Lian: It would be helpful. And then I have a follow up.

Brian Lian: Yeah, I'd say on both of those little too early to tell we can't.

Brian Lian: Really predict where the weight loss might land after 13 weeks when.

Brian Lian: When we look at the <unk>.

Brian Lian: The four week.

Brian Lian: Graphs.

Brian Lian: You can see the trends continuing downward, but where do those go from here, it's really hard to predict.

Brian Lian: With COGS, you know, I think it's premature to start discussing COGS as we're in a phase two trial with the program. We certainly wouldn't want to target a product that isn't profitable though.

Brian Lian: With Cogs.

Speaker Change: I think it's premature to start discussing Cogs.

Speaker Change: We're in a phase II trial with the program, we certainly wouldn't want to target a product that isn't profitable though.

Monyink Mompanyi: Okay, got it.

Speaker Change: Okay.

Brian Lian: And then you know the concepts like weight regain or lean muscle mass preservation, any plans to study that as part of these phase 2 studies, the oral and the once monthly sub-Q, or is that is that more TBD as the question asked? Studies for Graduates. Well, the maintenance study that I think Jay asked about would be really to target weight regain. So that's where we dose people using the weekly regimen up to a high dose and then transition them to a monthly injection or a low dose daily oral. And the primary objective is to understand how weight regain manifests after you make that transition to either the monthly or the low dose oral.

Speaker Change: Got it and then.

Speaker Change: The concepts like wait regain our lean muscle mass preservation.

Speaker Change: Any plans to study that as part of these phase II studies.

Speaker Change: Once monthly <unk>.

Speaker Change: Or is that is that more TBD as those studies.

Speaker Change: Studies progress.

Speaker Change: Well the maintenance study that I think.

Speaker Change: Jay asked about would be really to target weight regained so that's where we are.

Speaker Change: Dose people using the weekly regimen up to a high dose and then transition them to a monthly injection or a low dose daily oral and the primary objective is to understand how weight regain manifests after you trends that make that transition to either monthly or the law.

Speaker Change: <unk> oral.

Brian Lian: Muscle Mass Preservation, is that more Hamelin focused? No, we're, we will do DEXAs in the phase three program, but no intention at this point to evaluate, you know, like our 5211 molecule for muscle presentation, but we will be doing DEXAs. I think everybody's doing DEXAs in their in their phase three programs on a subset of patients. Got it.

Speaker Change: Lean muscle mass preservation Hamelin focused.

Speaker Change: No.

Speaker Change: We will do <unk> in the phase III program, but.

Speaker Change: No intention at this point too.

Speaker Change: Evaluate like our five to one one molecule for muscle presentation, but we will be doing that because I think everybody is new indexes and they're in their phase III programs on a subset of patients.

Speaker Change: Got it and lastly on <unk>, obviously, you've been.

Monyink Mompanyi: And lastly on 2809 from MASH, obviously you've been, you know, working through the post end of phase two feedback and obviously having strategic discussions. Is there any update to how maybe the counterparty feedback might be coming as obviously there have been slew of positive commercial and clinical updates in that space that, you know, could warrant a very positive return on investment? And maybe the complexity is not as bad as maybe it was thought a few years ago.

Speaker Change: Looking through the post end of phase II feedback and obviously, having strategic discussions as any.

Speaker Change: Beg to how maybe the current dividing feedback might be coming as obviously, they would have been positive commercial and clinical updates in that space that could warrant very positive return on investment.

Speaker Change: And maybe the complexity is not as.

Speaker Change: Bad as maybe it was talked a few years ago. Thanks for taking my questions.

Brian Lian: Thanks for the Yeah, sure. Well, hard to comment on discussions around partnering for really either of the assets. We had a very busy schedule at J.P. Morgan and we're in the follow-up period now, but nothing further to say at this time on partnering. I think, you know, the overhang with the MASH program is the requirement for biopsies, and that does complicate phase three trials, but, you know, we'll see where some of the conversations lead. Got it.

Speaker Change: Yes sure.

Speaker Change: Well.

Speaker Change: Hard to comment on on discussions around.

Speaker Change: Partnering really either either the assets, we had a very busy sketch.

Speaker Change: Schedule at Jpmorgan and we're in the follow up period, now, but nothing further to say.

Speaker Change: At this time on partnering I think the overhang with the.

Speaker Change: The mash program is the requirement for biopsies and that does complicate.

Speaker Change: Phase III trials, but.

Speaker Change: We'll see where some of the conversations lead.

Speaker Change: Got it thank you thanks.

Monyink Mompanyi: Thank you. Thanks, Lyle.

Mark: Thanks Mark.

Biran Amin: And the next question comes from Biran Amin with Piper Sandler. Please go ahead. Yeah. Hi, guys. Thanks for taking my questions.

Speaker Change: And the next question comes from beer in men with Piper Sandler. Please go ahead.

Speaker Change: Yeah, Hi, guys. Thanks for taking my question, maybe let me just start with a monthly sub Q dose.

Biran Amin: Maybe let me just start with the monthly sub-Q dose study. Is the plan to evaluate the 10 and 15 milligram doses? And how are you thinking about timing of the start of the monthly sub-Q relative to the phase three weekly sub-Q? We're not going to disclose the doses until we get to the study initiation, but we would intend to keep people on the weekly for probably four weeks before we transition them to the monthly, but all those details we would disclose when we start the study.

Speaker Change: <unk> is the plan to evaluate the 10 and 15 milligram doses and how are you thinking about timing of the sort of the monthly sub Q relative to the phase III weekly subcutaneous studies.

Speaker Change: Yeah, yeah. Thanks.

Speaker Change: We're not going to disclose the doses until we get.

Speaker Change: Two the study initiation, but we would intend to keep people on the weekly for <unk>.

Speaker Change: Probably four weeks before we transition them to the to the monthly but all those details we would disclose when we start the study.

Brian Lian: Got it.

Speaker Change: Got it and then maybe a follow up question on the Amylin program what needs to be completed Friday submission this year.

Biran Amin: And then maybe a follow-up question. On the AMLIN program, what needs to be completed for IND submission this year? Well, all of the IND enabling work, particularly the talks work, but we hope to have that done to enable an IND filing this year.

Speaker Change: Well all of the IND, enabling work, particularly the Tox work.

Speaker Change: We hope to have that done to enable an IND filing this year.

Speaker Change: Great. Thanks.

Biran Amin: Thanks, Barron.

Speaker Change: Thanks Darren.

Hardik Parikh: And the next question comes from Hardik Parikh with JP Morgan. Please go ahead. Hey, Brian. Thanks for all the updates today. A couple of questions.

Speaker Change: And the next question comes from <unk> Parikh with J P. Morgan. Please go ahead.

Speaker Change: Hey, Brian that's where all the updates today couple of questions. The first is on the <unk> program. So I believe it was at the at our conference in January where you announced that the first time that you would also be studying it in the type two diabetes plus obesity population was that originally part of your plan or was that more of a result.

Hardik Parikh: The first is on the Sub-Q program. So, I believe it was at our conference in January where you announced that for the first time that you would also be studying it in the type 2 diabetes plus obesity population. Was that originally part of your plan or was that more of a result of the FDA meetings you've had?

Speaker Change: The FDA meetings, you've had and then the second one is on the oral program.

Hardik Parikh: And then the second one is on the oral program. You said data in the second half of the year. Is there any kind of thought process on whether that data would be headline data or could we see a full readout in the second half?

Speaker Change: Data in the second half of the year is there any kind of thought process on whether that data will be headline data or could we see a full readout.

Speaker Change: Second half thank you.

Brian Lian: Thank you. Yeah, thanks, Hardik.

Eric: Yeah. Thanks, Eric.

Brian Lian: The data timing, generally, we report top-line data when it's available, and then the final data are generally reported later. So when we have the key elements of the top-line data set, which, you know, will probably be body weight change and safety profile, we would intend to release it.

Speaker Change: <unk>.

Speaker Change: The the data timing, we generally we report top line data when it's available and then the final data are generally reported later so when we have the the key elements of the topline data set which will probably be body weight change and safety profile, we would we wouldn't it.

Speaker Change: Tend to release it with the phase III trial choices.

Brian Lian: With the phase three trial choices. The playbook there is, it's not unique to us, is generally a phase three study in obese subjects. And then a separate phase 3 study in obese subjects with type 2 diabetes. And the obesity studies, the larger of the two, diabetes would be the smaller of the two. But that enables some discussion of glycemic control in the label.

Speaker Change: The playbook there is not unique to us is generally a phase III study in obese subjects.

Speaker Change: And then a separate phase III study in obese subjects with type two diabetes and.

Speaker Change: Obesity studies, the larger of the two diabetes would be the smaller of the two but that enables some discussion of glycemic control in the label.

Hardik Parikh: Just one more, just to follow up on the AMLIN program. You're still deciding which candidate you're going to take forward. Is it possible that it could be one of those assets that you disclosed, I believe, back in ADA last year? Yeah, it's possible. We have a A number that look really interesting, but that that's possible. Yeah.

Speaker Change: Okay, and then just one more.

Speaker Change: To follow up on the Amylin program.

Speaker Change: R R.

Speaker Change: Uh huh.

Speaker Change: You are still deciding which rich candidate youre going to kind of take forward.

Speaker Change: Hospital that could be one of those assets that you disclosed I believe back in 88 last year.

Speaker Change: Yes, it's possible we have.

Speaker Change: The number that look really interesting, but that's possible yes.

Hardik Parikh: Okay, thank you. Thanks, Hardik.

Speaker Change: Okay. Thank you.

Charlie: Thanks, Charlie.

Andy Shea: And the next question comes from Andy Shea with William Blair. Please go ahead. Thanks for taking our questions. Just curious about your your view on on PK as data were presented at the obesity week.

Speaker Change: And the next question comes from Andy Shay with William Blair. Please go ahead.

Speaker Change: Thanks for taking our questions just.

Speaker Change: Curious about your view on on PK data.

Speaker Change: Data were presented at <unk> so.

Brian Lian: So, first, looking at the accumulation, I'm curious if there's like, like a multiple that you're looking for in the initial phase, you know, that would lend. evidence to potentially longer dosing interval, like you mentioned, the monthly dosing interval. And then also, in terms of the plasma level, is there like a minimum that you're looking at, at the end of week four, to give you confidence that the weight regain would be minimized? Yeah, good, good questions. The way we looked at starting with the second question, It seems as though, when we look at that 2.5 mg dose over 13 weeks, that leads to 9% weight loss, which is pretty good.

Speaker Change: First looking at the accumulation.

Speaker Change: I'm curious if there was like a like a bolt Paul that youre looking for in the initial phase.

Speaker Change: That way.

Speaker Change: Land.

Speaker Change: Evidence to potentially longer dosing interval like like <unk> mentioned that the monthly dosing intervals and then also in terms of the plasma level is there like a minimum.

Speaker Change: You are looking at at the end of week four to give you confidence that the weight regain would be minimized.

Speaker Change: Yeah. Good good question the way we looked at the start with the second question.

Speaker Change: It seems as though when we look at that two and a half make dose over 13 weeks that leads to 9% weight loss, which is.

Speaker Change: Pretty good.

Brian Lian: So it feels like if you can maintain plasma levels in the neighborhood of that two and a half mg dose after four weeks, you know, four weeks from the from the prior dose, you're probably in a range that will prevent any significant weight gain. And so that's just kind of high level the way we're we're looking at. And yeah, there's more there more numbers behind that, but that's kind of the way we consider it. With the accumulation, interesting when you look at the accumulation graphs, even the five milligram cohort after 13 weeks is still accumulating.

So it feels like if you can maintain plasma levels in the neighborhood of that $2 five make dose after four weeks four weeks from the from the prior dose youre probably in a range that will prevent any significant weight gain.

Speaker Change: And so that's just kind of a high level the way, we're looking at it and yes, there is more and more numbers behind that but that's kind of the way we consider it.

Speaker Change: <unk>.

Speaker Change: With the accumulation.

Speaker Change: Interesting when you look at the accumulation graphs.

Speaker Change: Even the five milligram.

Speaker Change: Cohort. After 13 weeks is still accumulating and I think that speaks to the.

Brian Lian: And I think that speaks to the Highly differentiated half-life we have that allows accumulation to happen, you know, even though you've been affixed at that 5 milligram dose for 10 weeks in that study, there's still an accumulation ongoing.

Speaker Change: Highly differentiated half life, we have that allows the accumulation to happen.

Speaker Change: Even though <unk> been fixed at the five milligram dose for for 10 weeks in that study there is still an accumulation ongoing so where does it go at higher doses, we're not quite sure, but I think it's it suggests that the 13 week data probably.

Brian Lian: So where does it go at higher doses? We're not quite sure, but I think it suggests that the 13-week data probably, you know, understate the long-term efficacy of what's possible.

Understate long term efficacy of what's possible.

Andy Shea: And just a quick follow-up, Brian.

Brian Lian: And just a quick follow up Brian I'm curious.

Brian Lian: I'm curious with the accumulation graph that you showed, would you be able to provide the follow-up period? So, for example, like a 16-week follow-up with the accumulation PK, or that's simply not measured in the Venture Study? Yeah, well, that is actually the graph below it in the poster. When you look at the plasma level decay, that's over the following seven weeks.

Speaker Change: With the accumulation graph that you showed.

Speaker Change: Would you be able to provide the follow up period. So for example.

Speaker Change: Like a 16 week follow up with the accumulation PK or that's simply not measured in debenture study.

Speaker Change: Yeah.

Speaker Change: Yes, well that is actually the graph below it in the poster when you look at the <unk>.

Speaker Change: Plasma level decay, that's over the following seven weeks, so that would be.

Brian Lian: So that would be 19 weeks total in that, I mean, the final time point in that second graph would represent 19 weeks from day one of the study, if that makes sense. Okay. All right. Right, right, that's right, that's right. Okay, that makes sense. Okay, great.

Speaker Change: 19 weeks totaled in that.

Speaker Change: The final time point in that second graph would represent 19 weeks from day, one of the study that makes sense.

Speaker Change: So second chapter.

Speaker Change: Alright, great Thats right Thats right, Okay that makes sense, okay, great. Thanks, so much Ryan yes.

Andy Shea: Thanks so much, Brian. Yeah, thanks, Andy.

Speaker Change: Yes. Thanks.

Yale Jen: And the next question comes from Yale Jen with Laidlaw and Company.

Yale Jen: And the next question comes from Yale Jen with Laidlaw and company. Please go ahead.

Yale Jen: Please go ahead. Great, thanks for taking the questions and congrats on the progress. Just a few quick ones. The first is that for the phase 3 study in terms of type 2 diabetes patients, would you also potentially seek a label on the diabetes alone or simply just as part of the obesity? Then I have a follow-up. Yeah, thank you. It's a great question. Really, we wouldn't be submitting a type 2 diabetes package for approval for treatment of type 2 diabetes. It's for inclusion in an obesity label in people with obesity and type 2 diabetes.

Yale Jen: Oh, great. Thanks for taking the questions and congrats on the progress just a few.

Yale Jen: Two quick ones. The first is that for a bit.

Speaker Change: Our phase III study in terms of type two diabetes patients would you also potentially to seek a label on the diabetes alone or is simply just that part of the obesity and I have a follow up.

Speaker Change: Yeah. Thanks, Joe that's a great question really we wouldn't be submitting a type two diabetes package for approval for.

Speaker Change: <unk> for treatment of type two diabetes, it's for.

Speaker Change: The inclusion and in obesity label.

Speaker Change: In people with obesity and type two diabetes.

Brian Lian: And a follow-up question here is that in terms of material preparing, is auto-injector part of that? And if so, what's the situation there? Yeah, we do plan to introduce an auto-injector in the Phase 3 program. So we would anticipate the product to launch as an auto-injector. And do you need to do a region study on that? Or that's not necessary if you don't start with the auto-injector for the Phase 3? Yeah, we probably would do a bridging study just to make sure that we have bioequivalence with the autoinjector, so I think that would be the intention there.

Speaker Change: And a follow up question here is that in terms of a material preparing.

Speaker Change: Is auto injector part of that and if so.

Speaker Change: What's the situation there.

Speaker Change: Yes, we do plan to.

Speaker Change: Introducing an auto injector in the phase III program. So we would anticipate the product to launch as an auto injector.

Speaker Change: And do you need to do.

Speaker Change: Bridging study on that Oh, that's that's done necessarily if you don't start with the auto injector kept careful to phase III.

Speaker Change: Yes, we probably would do a bridging study just to make sure that we have bio equivalents with the auto injector.

Speaker Change: So I think that would be the intention there.

Yale Jen: Okay, great.

Speaker Change: Okay, great. Thanks, a lot and again congrats on all the progress.

Yale Jen: Thanks a lot.

Yale Jen: And again, congrats on all the progress.

Yale Jen: Thanks a lot, you.

Speaker Change: Thanks, a lot.

Justin Zelin: Again, if you have a question, please press star and then one. Our next question comes from Justin Zelin with BTIG. Please go ahead. Thanks for taking the questions and congrats on the updates here.

Speaker Change: Again, if you have a question. Please press star and then one our next question comes from Justin <unk> with <unk>. Please go ahead. Thanks.

Speaker Change: Thanks for taking my questions and congrats on the updates here, Brad I wanted to ask about the upcoming late stage oral small molecule, obviously read out in the field and just your latest thoughts on the benefits associated with them and the scalability of peptide API as compared to small molecules.

Justin Zelin: Brian, I wanted to ask about the upcoming late stage oral small molecule obesity readout in the field and just your latest thoughts on the benefits associated with and the scalability of peptide API as compared to small molecules. Yeah, so hard to predict the data upcoming. It's always, I always do a bad job at that, but. you know, we'll wait for it just like everybody else. As far as scalability of peptides versus small molecules, I think there is some misperception out there that the small molecules are universally easier to make than peptides. That's, I mean, I'm a small molecule chemist, that's totally false, but I know that's the perception.

Speaker Change: Yes, so hard to predict the data upcoming it's always I always do a bad job at that.

Speaker Change: But.

Speaker Change: We'll wait for just like everybody else.

Speaker Change: As far as scalability of peptides versus small molecules I think there is some misperception out there that the small molecules are universally easier to make them peptides.

Speaker Change: I'm, a small molecule chemistry totally false, but I know that's the perception peptide chemistry is pretty simple it's pretty.

Brian Lian: Peptide chemistry is pretty simple, it's pretty low-tech. It's scalability that is the challenge, the chemistry is not. And we're, I think, comfortable that we'll be able to produce scale that supports a multi-billion dollar franchise. Thanks again, Brian.

Speaker Change: Low tech.

Its scalability that is the challenge the chemistry is not.

Speaker Change: And we're I think comfortable that we'll be able to produce scale that supports a multibillion dollar franchise.

Brian Lian: Thanks, again, Brian and congrats again.

Justin Zelin: Congrats. Thanks, Justin.

Speaker Change: Thanks, Justin.

Fiona Gia: And the next question comes from Fiona Gia with Jeffreys. Please go ahead. Hi, Jean. Thanks for taking the question, and congrats on the quarter. So, my question is on the AMLIN program. Can you just comment on the, like, characterization of the compound that you selected? Because I seem to remember from ADA, most of the compounds seem to follow a balanced profile, but I think there are, like, one or two that are more AMLIN-biased. Can you comment on the, like, any characterization of the DC that you might select? Yeah, all of them are, well, we do have a range, but the ones that are of greatest interest are much more balanced, more toward that one-to-one when you look at the, I think we look at Calcitonin to amylin-3, pretty much a one-to-one, maybe up to three or five-to-one, but as close to one-to-one.

Speaker Change: And the next question comes from Fiona <unk> with Jefferies. Please go ahead.

Fiona: Hi team Thanks for taking my question.

Fiona: In the quarter. So my question is on the Amylin program.

Fiona: Can you just comment on the characterization of that.

Speaker Change: Compound I liked it because I seem to remember from.

Speaker Change: 88, most of the compound seem to follow a balanced profile, but I think there are like one.

Speaker Change: One or two that are more amylum biased.

Speaker Change: Can you comment on like any characterization of the D. C that you might like.

Speaker Change: Yet all of them are well, we do have a range, but the ones that are of greatest interest are much more balanced more toward that one to one.

Speaker Change: When you look at the I think we look at.

Speaker Change: <unk> tone into two amylin three.

Speaker Change: Pretty much.

Speaker Change: One to one maybe up to three or five to one but as close as possible to one to one.

Brian Lian: So, yeah. it's possible to one-to-one.

I'm not sure that answers the question, but got it very helpful. Thank you.

Fiona Gia: I'm not sure that answers the question, but that's it.

Fiona Gia: Yeah, very helpful.

Fiona Gia: Thank you.

Fiona Gia: Thanks Jonah.

Nina: Thanks Nina.

Stephanie Diaz: 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 very much for joining us today. We look forward to updating you again in the coming months.

Nina: This concludes our question and answer session I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Nina: Thank you very much for joining us today, we look forward to updating you again in the coming months have a good afternoon.

Stephanie Diaz: Have a good afternoon.

Operator: The conference has now concluded. Thank you for attending today's presentation.

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

Operator: You may now disconnect.