Q1 2024 Viking Therapeutics Inc Earnings Call
Operator: Welcome to the Viking Therapeutics First Quarter 2024 Financial Results Conference Call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key, followed by 1 on your touch-tone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference call is being recorded today, April 24th, 2024. I would now like to turn the conference over to Vikings Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.
Welcome to the Viking Therapeutics first quarter 'twenty 'twenty four financial results conference call.
At this time all participants are in listen only mode. Following management's prepared remarks, we will hold a Q&A session.
To ask a question at that time. Please press the Starkey followed by one on your Touchtone phone.
If anyone has difficulty hearing the conference. Please press star zero for operator assistance.
As a reminder, this conference call is being recorded today April 24th 2024.
I would now like to turn the conference over to Viking's manager of Investor Relations. Stephanie Diaz. Please go ahead Stephanie.
Stephanie Diaz: Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Vikings President and CEO, and Greg Zante, Vikings CFO.
Stephanie Diaz: Hello, and thank you all for participating in today's call. Joining me today is Brian Lane, 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, April 24, 2024, will contain forward-looking statements under the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines, and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and significantly, and reported results should not be considered as an indication of future performance.
Stephanie Diaz: Before we begin I'd like to caution that comments made during this conference call today April 'twenty four 'twenty 'twenty four will contain forward looking statements under the safe Harbor provisions of the U S. Private Securities Litigation Reform Act of 1995 <unk>.
Including statements about <unk> 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.
Stephanie Diaz: These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. 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.
Stephanie Diaz: These forward looking statements speak only as of today's date and the company undertakes no obligation to revise or update any statement made today.
Stephanie Diaz: I encourage you to review all of the Companys filings with the Securities and Exchange Commission concerning these and other matters I will now turn the call over to Brian Lian for his initial comments.
Brian Lian: Thanks Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today we'll review our financial results for the first quarter ended March 31st, 2024 and provide an update on recent progress with our clinical programs and operations. During the first quarter, Viking announced positive results from two of the company's key pipeline programs. First, our Phase II Venture Study, evaluating our dual GLP-1 and GIP receptor agonist VK2735 in patients with obesity, successfully achieved its primary endpoint and all secondary endpoints, demonstrating statistically significant reductions in body weight at all doses as compared to placebo.
Brian Lian: Thanks, Stephanie and good afternoon to everyone listening in by phone or on the webcast.
Brian Lian: Today, We will review our financial results for the first quarter ended March 31 2024.
Brian Lian: I had an update on recent progress with our clinical programs and operations <unk>.
Brian Lian: During the first quarter Viking announced positive results from two of the company's key pipeline programs.
Our phase II venture study evaluating our dual G. L. P. One and G. IP receptor agonist VK two 735 in patients with obesity successfully achieved its primary endpoint and all secondary endpoints demonstrating statistically significant reductions in body weight at all doses as compared to placebo.
Brian Lian: Also during the quarter, the company announced results from a Phase I clinical trial evaluating an oral tablet formulation of VK2735. This study demonstrated encouraging safety and tolerability, as well as promising weight loss following 28 days of once-daily dosing.
Brian Lian: Also during the quarter the company announced results from a phase one clinical trial evaluating an oral tablet formulation of VK two 735.
Brian Lian: This study demonstrated an encouraging safety and tolerability as well as promising weight loss. Following 28 days of once daily dosing.
Brian Lian: The company plans to advance both of these programs into further development later this year. In addition, during the first quarter, the company completed the final biopsies in the Phase IIb voyage study, evaluating the novel thyroid hormone receptor beta-agonist, VK2809, in patients with NASH and fibrosis. We expect to report the biopsy results from this study later this quarter.
Brian Lian: The company plans to advance both the both of these programs into further development later this year.
Brian Lian: In addition, during the first quarter the company completed the final biopsies in the phase <unk> voyage study evaluating the novel thyroid hormone receptor beta agonist VK, two eight or nine in patients with Nash and fibrosis. We expect to report the biopsy results from this study later this quarter.
Brian Lian: Finally, during the quarter, Viking completed a public offering of common stock, raising gross proceeds of approximately $630 million. These funds substantially strengthen the company's balance sheet and will support our plans to aggressively develop our pipeline. I'll provide further details on our operations and development activities after we review our financial results for the first quarter of 2024. After that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
Brian Lian: Finally during the quarter Viking completed a public offering of common stock raising gross proceeds of approximately $630 million.
Brian Lian: These funds substantially strengthened the company's balance sheet and will support our plans to aggressively develop our pipeline.
Brian Lian: I'll provide further details on our operations and development activities. After we review our financial results for the first quarter of 2024.
Brian Lian: With that I'll turn the call over to Greg Zante, Viking's, Chief Financial Officer.
Gregory S. Zante: Brian, in conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 key filing with the Securities and Exchange Commission, which we expect to file later today. I'll now go over the results for the first quarter ended March 31st, 2024. Research and development expenses were $24.1 million for the three months ended March 31, 2024, compared to $11 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates and preclinical studies.
Gregory S. Zante: Thanks, Brian and.
Gregory S. Zante: In conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later today.
Gregory S. Zante: I'll now go over there our results for the first quarter ended March 31 2024.
Gregory S. Zante: Research and development expenses were $24 1 million for the three months ended March 31, 2024 spread to 11 million for the same period in 2023.
The increase was primarily due to increased expenses related to manufacturing for our drug candidates preclinical studies clinical studies stock based compensation salaries and benefits and services provided by third party consultants.
Gregory S. Zante: Clinical Studies, Stock-Based Compensation, Salaries and Benefits, and services provided by third-party consultants. General and administrative expenses were $10 million for the three months ended March 31, 2024, greater than $9.5 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries, and benefits, and services provided by third-party consultants, partially offset by decreased expenses related to legal and patent services. For the three months ended March 31st, 2024, Viking reported a net loss of $27.4 million, or $0.26 per share, compared to a net loss of $19.5 million, or $0.25 per share, in the corresponding period in 2023
Gregory S. Zante: General and administrative expenses were $10 million for the three months ended March 31, 2024 compared to.
$9 5 million for the same period in 2023.
Gregory S. Zante: The increase was primarily due to increased expenses related to stock based compensation salaries and benefits and services provided by third party consultants, partially offset by decreased expenses related to legal and patent services.
Gregory S. Zante: For the three months ended March 31, 2020 for Viking reported a net loss of $27 4 million or <unk> 26 per share compared to a net loss of $19 5 million or 25 per share in the corresponding period in 2023.
Gregory S. Zante: The increase in net loss for the three months ended March 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. Turning to the balance sheet, at March 31, 2024, Viking held cash, cash equivalents, and short-term investments of $963 million compared to $362 million as of December 31, 2023. The first quarter balance reflects the receipt of gross proceeds of $630 million from the company's public offering, which closed on March 4th, 2024. This concludes my financial review, and I'll now turn the call back over to Brian.
Gregory S. Zante: The increase in net loss for the three months ended March 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.
Gregory S. Zante: Turning to the balance sheet at March 31, 2020 for Viking held cash cash equivalents and short term investments of $963 million compared to 362 million as of December 31 2023.
Gregory S. Zante: First quarter balance reflects receipt of gross proceeds of $630 million from the company's public offering which closed on March four 2024.
Gregory S. Zante: This concludes my financial review and I'll now.
Gregory S. Zante: I'll turn the call back over to Brian.
Brian Lian: The first quarter of 2024 was an eventful quarter as we received and reported the results from two key clinical trials, our Phase 2 Venture Trial evaluating subcutaneous VK2735 in patients with obesity and our Phase 1 Clinical Trial evaluating an oral tablet formulation of VK2735 in healthy volunteers. Both studies were successful, demonstrating promising weight loss and favorable safety and tolerability, and we look forward to advancing both of these programs into further development later this year.
Brian: Thanks, Greg.
Brian: The first quarter of 2024 was an eventful quarter as we received and reported the results from two key clinical trials are phase III venture trial evaluating subcutaneous VK two 735 in patients with obesity and our phase one clinical trial evaluating an oral tablet formulation of VK two 735 in healthy volunteers.
Brian: Both studies were successful demonstrating promising weight loss and favorable safety and Tolerability and we look forward to advancing both of these programs into further development later this year.
Brian: As we have recently reviewed the results from each of these studies on separate conference calls I'll briefly review key takeaways in my prepared comments and refer you to our February 27, and March 26th press releases for more details.
Brian Lian: As we have recently reviewed the results of each of these studies on separate conference calls, I'll briefly review key takeaways in my prepared comments and refer you to our February 27th and March 26th press releases for more details. In addition, I'm happy to provide further detail in the Q&A portion of the call.
Brian: In addition, I'm happy to provide further detail in the Q&A portion of the call.
Brian: I will first provide an update on our subcutaneous formulation of VK two 705 for obesity.
Brian: VK two 735 is a dual agonist of the glucagon like peptide one or <unk>, one receptor and the glucose dependent insulin the tropic polypeptide or <unk> receptor.
Brian Lian: I will first provide an update on our subcutaneous formulation of VK2735 for obesity. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor, and the glucose-dependent insulinotropic polypeptide, or GIP receptor. In the first quarter of 2023, we announced positive results from a phase 1 single ascending dose and multiple ascending dose study of VK2735. This study demonstrated the promising safety, tolerability, and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection for four weeks. In addition, subjects in the study demonstrated up to 7.8% weight loss from baseline after 28 days with no signs of plateau.
Brian: In the first quarter of 2023, we announced positive results from a phase one single ascending dose and multiple ascending dose study of VK 2735. This study.
Brian: <unk> demonstrated the promising safety Tolerability and pharmacokinetics of VK two 735, when administered as a weekly subcutaneous injection for four weeks.
Brian: In addition subjects in the study demonstrated up to seven 8% weight weight loss from baseline after 28 days with no signs of plateau.
Brian: Based on these positive results Viking initiated a phase II trial called debenture trial to evaluate decay to 735 in patients with obesity.
Brian: The venture 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: Based on these positive results, Viking initiated a Phase 2 trial called the Venture Trial to evaluate VK2735 in patients with obesity. The Venture 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, Viking announced positive top-line results from the venture study. This trial successfully achieved its primary end point and all secondary end points, with patients receiving VK2735 demonstrating reductions in body weight at all doses compared with placebo.
Brian: In the first quarter Viking announced positive topline results from the venture study.
This trial successfully achieved its primary endpoint and all secondary endpoints with patients receiving VK two 735, demonstrating reductions in body weight at all doses compared with placebo.
Brian: For the primary endpoint patients receiving VK, two 735 demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14, 7% as well as statistically significant reductions in mean body weight relative to placebo ranging up to 13, 1%.
Brian: Statistically significant differences compared to placebo were observed for all VK two 735 doses starting at week, one and were maintained throughout the course of the study.
Brian Lian: For the primary endpoint, patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7%, as well as statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%. Statistically significant differences compared to placebo were observed for all VK2735 doses starting at week one and were maintained throughout the course of the study. Weight loss in all treated cohorts was progressive through 13 weeks and did not show evidence of plateauing.
Brian: Weight loss in all treated cohorts was progressive through 13 weeks and did not show evidence of plateauing.
Brian: We believe this suggests that further weighed loss could be achieved through extended dosing beyond the 13 week treatment period of this study.
Brian: Additionally, the venture study showed VK 2735 treatment to be safe and well tolerated over 13 week trial with the majority of treatment emergent adverse events being characterized as mild or moderate.
Brian: Based on the phase two venture results as well as prior phase one results.
Brian: Viking plans to meet with the FDA later this quarter to discuss next steps in the development of VK two 735.
Brian: In addition to the subcutaneous formulation. The company is also developing a novel oral tablet formulation of VK two 785.
Brian: We believe a tablet formulation could represent an attractive treatment option for patients with obesity and we see this as an important potential expansion of the overall opportunity for the program.
Brian Lian: We believe this suggests that further weight loss could be achieved through extended dosing beyond the 13-week treatment period of this study. Additionally, the Venture study showed VK2735 treatment 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. Based on the Phase 2 venture results, as well as prior Phase 1 results, plans to meet with the FDA later this quarter to discuss next steps in the development of VK2735.
Brian: Last year, we initiated an extension of the previously reported subcutaneous phase one study to incorporate an evaluation of our tablet formulation.
Brian: The oral portion of this study is a randomized double blind placebo controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter square.
The primary objective is to evaluate the safety and Tolerability of VK 2735 administered as a tablet once daily for 28 days.
Brian Lian: In addition to the subcutaneous formulation, the company is also developing a novel oral tablet formulation of VK2735. We believe a tablet formulation could represent an attractive treatment option for patients with obesity, and we see this as an important potential expansion of the overall opportunity for the program.
Brian: Secondary and exploratory objectives include an evaluation of the pharmacokinetics of orally administered VK, two 735, as well as various pharmacodynamic measures, including changes in body weight and other metrics.
Brian: During the first quarter, we reported the initial data from this study.
With respect to safety and Tolerability oral VK, two 735 was shown to be safe and well tolerated. Following once daily dosing for up to 28 days at doses that were titrated up to 40 milligrams.
Brian Lian: Last year, we initiated an extension of the previously reported subcutaneous phase one study to incorporate an evaluation of our tablet formulation. The oral portion of this study is 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 is to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days. Secondary and exploratory objectives include an evaluation of the pharmacokinetics of orally administered VK2735, as well as various pharmacodynamic measures, including changes in body weight and other metrics.
Brian: Among subjects, receiving these say two 735, all treatment emergent adverse events were reported as mild or moderate in severity with the majority 76% reported as mild.
Brian: Overall, no clinically meaningful differences were reported for gastrointestinal adverse events among subjects treated with VK, two 735 compared with placebo.
Brian: Importantly to date no serious adverse events have been reported in this study.
Brian: In addition to safety and Tolerability and exploratory assessment of change in body weight was conducted.
Brian: Subjects, receiving oral decay to 735 demonstrated dose dependent reductions in body weight, ranging up to five 3% from baseline.
Brian Lian: During the first quarter, we reported the initial data from this study. With respect to safety and tolerability, oral VK2735 was shown to be safe and well-tolerated following once-daily dosing for up to 28 days at doses that were titrated up to 40 mg. Among subjects receiving BCAE 2735, all treatment-emergent adverse events were reported as mild or moderate in severity, with the majority, 76%, reported as mild. Overall, no clinically meaningful differences were reported for gastrointestinal adverse events among subjects treated with VK2735 compared with placebo. Importantly, to date, no serious adverse events have been reported in this study. In addition to safety and tolerability, an exploratory assessment of change in body weight was conducted.
Brian: Placebo adjusted reduction in body weight reached up to three 3% from baseline.
Brian: Body weight reductions compared with baseline and placebo were statistically significant at the highest dose evaluated.
Brian: In addition weight loss during the 28 day window of this study was progressive at the 20 milligram and 40 milligram dose levels with no plateau observed.
Brian: Given the promising weight loss signal observed in this study along with the excellent tolerability profile thus far.
Speaker Change: <unk> is pursuing further dose escalation.
Speaker Change: In addition, based on the encouraging trajectory of weight loss and the lack of a plateau at 28 days for the higher dose cohorts, we believe that further benefits might be anticipated from longer dosing periods.
Speaker Change: To this end we are proceeding with plans for a phase II trial in patients with obesity and we expect to initiate this study later this year.
Speaker Change: Details on study design will be provided as we get closer to study initiation.
Brian Lian: Subjects receiving oral VK2735 demonstrated dose-dependent reductions in body weight, ranging up to 5.3% from baseline. Placebo-adjusted reductions in body weight reached up to 3.3% from baseline. Body weight reductions compared with baseline and placebo were statistically significant at the highest dose evaluated. In addition, weight loss during the 28-day window of this study was progressive at the 20-mg and 40-mg dose levels, with no plateau observed. Given the promising weight loss signal observed in this study, along with the excellent tolerability profile thus far, Viking is pursuing further dose escalation.
Speaker Change: I will now turn to our most advanced clinical program VK, two eight or nine for the treatment of Nash and fibrosis.
Speaker Change: <unk> 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.
Speaker Change: Last may we announced positive topline results from the phase <unk> voyage study of VK, two eight or nine.
Speaker Change: The voyage study is a randomized double blind placebo controlled multicenter international trial designed to assess the efficacy safety and Tolerability of VK two eight in patients with biopsy confirmed Nash and fibrosis.
Speaker Change: Enrollments included patients with at least 8% liver fat as measured by magnetic resonance imaging proton density fat fraction as well as F <unk> and F. Three fibrosis.
Speaker Change: Last may we reported that this study has successfully achieved its primary endpoint with patients receiving VK Twitter nine demonstrating statistically significant reductions in liver fat content from baseline to week 12, as compared with placebo.
Brian Lian: In addition, based on the encouraging trajectory of weight loss and the lack of a plateau at 28 days for the higher dose cohorts, we believe that further benefits might be anticipated from longer dosing periods. To this end, we are proceeding with plans for a Phase II trial in patients with obesity, and we expect to initiate this study later this year. Details on study design will be provided as we get closer to study initiation.
Speaker Change: The median relative change from baseline in liver fat among patients treated with VK Twitter nine ranged from 38% to 55% after 12 weeks.
Speaker Change: In addition up to 85% of patients receiving VK Twitter nine experienced at least a 30% reduction in liver fat.
Brian Lian: I will now turn to our most advanced clinical program, VK2809, for the treatment of NASH and fibrosis. VK2809 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. Last May, we announced positive topline results from the Phase 2b voyage study of VK2809.
Speaker Change: This level of efficacy is associated with a greater likelihood of histologic benefit in Nash.
Speaker Change: As in prior studies VK, two eight or nine treated patients also achieved statistically significant reductions in LDL cholesterol triglycerides and atherogenic lipoproteins.
Speaker Change: We believe these results indicate that VK, two eight or nine has the potential to provide longer term cardio protective benefits.
Brian Lian: The VOYAGE study is a randomized, double-blind, placebo-controlled, multi-center international trial designed to assess the efficacy, safety, and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. Enrollment included patients with at least 8% liver fat as measured by magnetic resonance imaging proton density fat fraction as well as F2 and F3 fibrosis. Last May, we reported that this study had successfully achieved its primary end point, with patients receiving VK2809 demonstrating statistically significant reductions in liver fat content from baseline to week 12, as compared with placebo.
Speaker Change: The initial voyage data also served to further establish VK 2000, nine's promising safety and Tolerability profile.
Speaker Change: 94% of treatment related adverse events among patients receiving VK two INO nine were reported as mild or moderate.
Speaker Change: Discontinuation due to adverse events were low and balanced among placebo and treatment arms in.
Speaker Change: In particular, VK, two eight or nine demonstrated an excellent gastrointestinal tolerability with similar rates of nausea, diarrhea, stool frequency and vomiting observed among VK toward a nine treated patients compared to placebo.
Speaker Change: Last November Viking presented additional data from this study at the annual meeting of the American Association for the study of liver diseases. These.
Speaker Change: These new data demonstrated robust liver fat reductions among patients with or without type two diabetes as well as those having either F two or F. Three fibrosis.
Brian Lian: The median relative change from baseline in liver fat among patients treated with VK-2809 ranged from 38% to 55% after 12 weeks. In addition, up to 85% of patients receiving VK-2809 experienced at least a 30% reduction in liver fat. This level of efficacy is associated with a greater likelihood of histologic benefit.
Speaker Change: Among patients with type two diabetes at week 12 reductions from baseline in liver fat ranged from 36% to 54%, which was comparable to the reductions observed among patients without type two diabetes.
Speaker Change: Treatment with VK Twitter nine also demonstrated potent reductions in liver fat among patients with either F. Two or F. Three fibrosis with liver fat reductions ranging up to approximately 58% from baseline.
Brian Lian: As in prior studies, VK2809-treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides, and atherogenic lipoproteins. We believe these results indicate that VK2809 has the potential to provide longer-term cardioprotective benefits. The initial voyage data also served to further establish VK-2809's promising safety and tolerability profile. For example, 94% of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate. Discontinuations due to adverse events were low and balanced between placebo and treatment offers.
Thus these results indicate that neither of the President's of type two diabetes, nor the presence of F. Two or F. Three fibrosis meaningfully impact VK, Twitter nine's efficacy in reducing liver fat.
Speaker Change: During the first quarter, we completed the final biopsies in the voyage study and remain on track to report the histology data from this study later this quarter.
Speaker Change: I'll now provide a brief update on our second thyroid hormone receptor beta agonist VK 0214, which is currently being evaluated in a phase one b trial in patients with X linked Adrenoleukodystrophy or X L D.
VK two Illinois VK 214 is also an orally available small molecule that is selective for the beta isoform of the thyroid hormone receptor.
Brian Lian: In particular, VK-2809 demonstrated excellent gastrointestinal tolerability with similar rates of nausea, diarrhea, stool frequency, and vomiting observed among VK-2809-treated patients compared to placebo. Last November, Viking presented additional data from this study at the annual meeting of the American Association for the Study of Liberty.
Speaker Change: 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.
Speaker Change: As a result patients are unable to efficiently metabolized very long chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X L. D.
In a prior phase one study in healthy volunteers VK 0214 demonstrated dose dependent exposures no evidence of accumulation and the half life consistent with anticipated once daily dosing.
Brian Lian: These new data demonstrated robust liver fat reductions among patients with or without type 2 diabetes, as well as those having either F2 or F3 fibrosis. Among patients with type 2 diabetes, at week 12, reductions from baseline in liver fat ranged from 36% to 54%, which was comparable to the reductions observed among patients without type 2 diabetes. Treatment with VK-2809 also demonstrated potent reductions in liver fat among patients with either F2 or F3 fibrosis, with liver fat reductions ranging up to approximately 58% from baseline.
Speaker Change: Subjects, who received <unk> 214 experienced reductions in LDL cholesterol triglycerides April LIFO protein B and lipoproteins.
Speaker Change: <unk> also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose related signals observed for Gi side effects vital signs or cardiovascular measures.
Speaker Change: The ongoing phase <unk> study of <unk> to one four is being conducted in patients with the adrenal Mylan neuropathy or a M N form of X L D, which is the most common form of the disorder.
Speaker Change: This trial is a randomized double blind placebo controlled multicenter study in adult male patients with AML.
Brian Lian: Thus, these results indicate that neither the presence of type 2 diabetes nor the presence of F2 or F3 fibrosis meaningfully impact VK-209's efficacy in reducing liver risk. During the first quarter, we completed the final biopsies in the VOYAGE study and remain on track to report the histology data from this study later this quarter. I'll now provide a brief update on our second thyroid hormone receptor beta agonist, VKO214, which is currently being evaluated in a Phase 1B trial in patients with X-linked adrenoleukodystrophy, or XALD.
Speaker Change: The primary objectives of this study are to evaluate the safety Tolerability and pharmacokinetics of VK 214 administered orally once daily for 28 days.
Speaker Change: The study also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids.
Speaker Change: The company expects to report the topline results from this trial in mid 2024.
Speaker Change: Finally during the first quarter the company successfully completed an underwritten public offering of common stock.
Speaker Change: The gross proceeds to Viking from this offering were approximately $630 million.
Speaker Change: As Greg indicated a few moments ago. These bonds have strengthened our balance sheet, which as of the end of the quarter held approximately $963 million in cash significantly extending our runway.
Brian Lian: Like VK2809, VKO214 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 peroxisomal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolize very long-chain fatty acids, and the accumulation of these compounds is believed to contribute to the onset and progression of XALD.
Speaker Change: This provides the company with the resources to aggressively develop our programs through important clinical milestones.
Speaker Change: In conclusion during the first quarter Viking reported positive data from two key clinical trials of our lead obesity program VK two 735 the.
Speaker Change: The phase II venture study demonstrated up to an approximately 15% reduction in body weight from baseline. Following 13 weeks of dosing by weekly subcutaneous injection as well as promising safety and Tolerability.
Brian Lian: In a prior Phase I study in healthy volunteers, VKO-214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily doses. Subjects who received DKO214 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B, and lipoprotein A. VKO-214 also demonstrated an encouraging safety and tolerability profile, with no serious adverse events The ongoing Phase 1b study of DKO214 is being conducted in patients with the adrenomyeloneuropathy, or AMN, form of XALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled, multi-center study in adult male patients with AMS.
Speaker Change: The phase one study of the oral tablet formulation of VK two to 705 demonstrated excellent safety and Tolerability and positive signs of clinical activity with subjects reporting mean weight loss of up to five 3% from baseline following 28 days of oral dosing.
Speaker Change: We plan to meet with regulators to discuss the path forward for each of these programs and we expect to initiate further clinical trials with each later this year.
Speaker Change: We also plan to report data from the phase two B voyage study of our thyroid hormone beta receptor agonist VK, two eight or nine in biopsy confirmed Nash and fibrosis later this quarter.
Speaker Change: The initial data from this study successfully achieved the primary endpoint and affirmed the VK Twitter nine's potent efficacy in reducing liver fat along with its favorable tolerability and safety profile we.
Speaker Change: We recently completed the final biopsies in the voyage study and look forward to reporting data on histologic changes assessed after 52 weeks of treatment later this quarter.
Speaker Change: Finally, we expect to announce data from our phase <unk> study of detailed to one four for the treatment of Drina Mylan neuropathy mid year.
Speaker Change: To support our maturing pipeline the company ended the quarter with a strong balance sheet of $963 million.
Speaker Change: This concludes our prepared comments for today, thanks, very much for joining us and we'll now open the call for questions operator.
Brian Lian: The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of VKO214 administered orally, once daily, for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very long-chain fatty acids. The company expects to report the top-line results from this trial in mid-2023. Finally, during the first quarter, the company successfully completed an underwritten public offering of common stock. The gross proceeds to Viking from this offering were approximately $630 million.
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 you are using a speaker phone please pick up your handset before pressing the keys if at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: The first question comes from Joon Lee with <unk>. Please go ahead.
Joon Lee: Hey, congrats on the quarter and thanks for taking our questions.
Cyclopean, Yeah, it's getting a lot of attention. These days and some companies are talking about adding SRM to GOP.
Joon Lee: You certainly have your share of experiences with farm and several opinion in general any thoughts on bringing back.
Brian Lian: As Greg indicated a few moments ago, these funds have strengthened our balance sheet, which as of the end of the quarter held approximately $963 million in cash, significantly extending our runway. This provides the company with the resources to aggressively develop our programs through important clinical milestones. In conclusion, during the first quarter, Viking reported positive data from two key clinical trials of our lead obesity program, VK2735. The Phase II Venture Study demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing by weekly subcutaneous injection, as well as promising safety and tolerability.
Speaker Change: One one of them that on strategy and I have a follow up.
Speaker Change: Hey June yes, thanks for the question, yes. It is.
I think getting to be more.
Speaker Change: Popular in the conversation what we.
Speaker Change: Have kind of always said Hasnt really changed is it's hard to understand the the.
June: The clinical significance of the loss in muscle and whether that actually has an impact on function or feeling or survival, which are what are typically used for approval.
June: Got.
June: It's a good point that 501, one compound is the most potent sorry that we're aware of and.
June: To the extent muscle losses considered to be <unk>.
Brian Lian: The Phase I study of the oral tablet formulation of VK2735 demonstrated excellent safety and tolerability and positive signs of clinical activity, with subjects reporting mean weight loss of up to 5.3% from baseline following 28 days of oral dosing. We plan to meet with regulators to discuss the path forward for each of these programs, and we expect to initiate further clinical trials with each later this year. We also plan to report data from the Phase 2b VOID study of our thyroid hormone beta receptor agonist VK2809 in biopsy confirmed NASH and fibrosis later this quarter.
June: Clinically relevant more so than the pharmacologic setting versus the regular diet and exercise setting it could be something that's that's really useful.
June: Okay.
Speaker Change: Looking forward to your update on that can you update us on where you are with the oral VK, two 725 dosing and what their.
Speaker Change: Stopping criteria or the maximum dose.
Speaker Change: Tend to test of the world.
Speaker Change: Yeah. Thanks, John Yes, it's ongoing is still in <unk>.
Speaker Change: We are.
Speaker Change: Planning to continue dose escalation until we either get too.
Speaker Change: Some sort of a some.
Speaker Change: Some reason for stopping and there may be a plateau on the exposures or.
John: So on the on the weight change or some tolerability issue and so we'll probably have more to say about that around the middle of the year. When we have data from the additional cohorts.
Brian Lian: The initial data from this study successfully achieved the primary endpoint and affirmed VK2809's potent efficacy in reducing liver fat, along with its favorable tolerability and safety profile. We recently completed the final biopsies in the VOYAGE study and look forward to reporting data on histologic changes assessed after 52 weeks of treatment later this quarter. Finally, we expect to announce data from our Phase 1b study of VKO214 for the treatment of adrenomyeloneuropathy mid-year. To support our maturing pipeline, the company ended the quarter with a strong balance sheet of $963 million.
Speaker Change: Right and one final question.
Speaker Change: Steady state.
Speaker Change: And around half year, Mark is that your expectation that VK 2735 would drive percent weight loss greater than towards the tight or would it be similar to tourists peptide and what is the basis for your thank you. Thank you.
Speaker Change: Sorry on the on the you're talking about the <unk>.
Speaker Change: The world.
Speaker Change: Yes, our injectable, let's say subcutaneous.
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. We will now begin the question.
Speaker Change: Oh for the subcutaneous.
Speaker Change: Well it seems that that at any given dose the exposures are significantly higher.
Speaker Change: And so.
Speaker Change: Whether it would be better or or comparable hard to say, but I think at any given dose we should have.
Operator: We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Joon Lee with Truist. Please go ahead.
Speaker Change: Greater load onboard without.
Speaker Change: In our view without without a meaningful change in the Tolerability profile. So how that translates I think we would have to see a longer study before making a call on that.
Speaker Change: Great well, thanks for all the answers and looking forward to our progress. Thank you.
Speaker Change: Thanks, a lot Jim.
Joon Lee: Hey, congrats on the quarter, and thanks for taking our questions. Cyclopenia is getting a lot of attention these days, and some companies are talking about adding a SARM to GLP. You certainly have your share of experiences with SARMs and cyclopenia in general. Any thoughts on bringing back, you know, 5211 as an add-on strategy? And I have a follow-up.
Speaker Change: The next question comes from Roger song with Jefferies. Please go ahead.
Roger Song: Hi team. This is commented on for Roger.
Roger Song: Maybe on VK 2809, what's the general translate ability of kind of a 12 week MRI PDF has resolved.
Roger Song: Later histology endpoints and.
Brian Lian: Hey Joon. Yeah, thanks for the question. Yeah, it is, I think, getting to be more popular in the conversation. What we have kind of always said and hasn't really changed is that it's hard to understand the clinical significance of the loss in muscle and whether that actually has an impact on function or feeling or survival, which are what are typically used for approval. It's a good point that 5-2-1-1 compound is the most potent SARM that we're aware of, and to the extent muscle loss is considered to be clinically relevant, more so in the pharmacologic setting versus the regular diet and exercise setting, it could be something that's really useful.
Roger Song: Are you planning to move the program into the match program into phase III yourself or do you intend to partner.
Roger Song: And then maybe as a third and final question. How do you think that thyroid beta agonist market will develop there's kind of been some recent evidence that G. L. P. One both dual G. L. P. One mg IP and dual G. L. P. One glucagon agonist shown potentially fibrosis improvement. So just your thoughts on how that market will develop.
Roger Song: Okay.
Speaker Change: Helpful. Thank you.
Yeah. Thanks, Thomas so with the translate ability for liver fat to histologic improvement.
Joon Lee: Okay, I'm looking forward to your updates on that. Can you update us on where you are with the oral VK2735 doses and what the... The stopping criteria or the maximum dose that you tend to test for oral.
Speaker Change: Generally it has been shown that reducing liver fat, particularly above that 30% relative reduction threshold has led to improved odds of histologic benefit there are some exceptions to that but generally there are more examples of that proving out then than not and I think it's more of a compound by campau.
Brian Lian: Yeah, thanks Joon. Yeah, it's ongoing still, and we are planning to continue dose escalation until we either get to some sort of a reason for stopping, either maybe a plateau on the exposures or a plateau on the weight change or some tolerability issue. And so we'll probably have more to say about that around the middle of the year when we have data from the additional cohorts.
Speaker Change: <unk>.
Speaker Change: The situation when you when you try to.
Translate precise liver fat reduction to histologic improvement I think the best comparator for us would be the other thyroid agonist that was recently approved it showed in the somewhere in the teens range for Nash resolution and it did show some improvement in fibrosis.
Joon Lee: Ray, and one final question, you know, at a steady state around half your mark. Is it your expectation that VK2735 would drive a percent weight loss greater than tercipatide or would it be similar to tercipatide, and what is the basis for your thinking? Thank you.
Speaker Change: <unk>.
Speaker Change: To the extent, we have a similar or better liver fat reduction I think that would be sort of the range. We would be looking at for Nash resolution and fibrosis improvement.
Brian Lian: Sorry on the on the oral. Were you talking about the oral or what?
Joon Lee: Yeah, for injectables, let's say subcutaneous. Oh, for the subcategories.
Brian Lian: The subcutaneous. Well, it seems that at any given dose, the exposures are significantly higher. And so, whether it would be better or comparable is hard to say. But I think at any given dose, we should have a greater load on board without, in our view, without a meaningful change in the tolerability profile. So how that translates, I think we would have to see a longer study before making a call on that. Wright
Speaker Change: With respect to the overall market, yes. It does seem like there is a rapid expansion of the <unk> one utilization.
Speaker Change: Utilization.
Speaker Change: And so.
Speaker Change: That probably does create some some some headwind on the uptick of new Nash drugs, but we've not had an approved drug for Nash. So now that we do I think it's going to be really important to see how the first few quarters.
Joon Lee: Great. Well, thanks for all the answers. I'm looking forward to your progress. Thank you.
Operator: The next question comes from Roger Song with Jeffries. Please go ahead.
Speaker Change: Mature there and.
Kambizan: Hi team, this is Kambizan for Roger. Maybe on VK2809, what's the general translatability of the 12-week MRI PDFF result into later histology endpoints and... Are you planning to move the program into the MASH program into Phase 3 yourself, or do you intend to partner? And then maybe as a third and final question, how do you think the thyroid beta agonist market will develop? There's kind of been some recent evidence that GLP-1s, both dual GLP-1 and GIP, and dual GLP-1 glucagon agonists have shown potential fibrosis improvement. So just your thoughts on how that market will develop and grow will be really helpful. Thank you.
Speaker Change: Maybe there is a backlog of people waiting to try it in the backlog of clinicians waiting to two.
Speaker Change: Prescribed it so unknown right now it's hard to hard to project, but it is true that the.
G L P ones are getting more and more utilization.
And there was a middle question in there I think I skipped.
Speaker Change: Yeah, just the plans on that.
Speaker Change: Phase III for your mash program kind of intend to do it for all of our per Penny search pickup partner.
Speaker Change: Yeah, Yeah, great, yes, so we.
Speaker Change: We plan to do is received the data from the voyage study and then we will schedule an end of phase II meeting with the FDA for later this year.
Speaker Change: And yet the current view of registration endpoints and.
Brian Lian: So with the translation of liver fat to histologic improvement, generally, it has been shown that reducing liver fat, particularly above that 30% relative reduction threshold, has led to improved odds of histologic benefit. There are some exceptions to that, but generally, there are more examples of that proving out than not.
Speaker Change: Any any trial design suggestions might the agency might have and.
Speaker Change: I think we'll have to see what the data look like but.
Speaker Change: We'll be probably looking for a partner with the program but.
Speaker Change: Hard to say without having a look at the data first.
Brian Lian: [inaudible] translate precise liver fat reduction to histologic improvement. I think the best comparator for us would be the other thyroid agonist that was recently approved. It showed somewhere in the teens range for NASH resolution, and it did show some improvement in fibrosis. So to the extent that we have a similar or better liver fat reduction, I think that would be sort of the range we would be looking at for NASH resolution and fibrosis improvement.
Speaker Change: Excellent. Thank you really appreciate Kansas.
Speaker Change: Thanks, Kevin.
Speaker Change: The next question comes from Annabel <unk> with Stifel. Please go ahead.
Annabel: Hi, Thanks for taking my questions I have two.
Annabel: On the oral so when you think about.
Annabel: The additional doses for the oral.
Annabel: <unk> already has shown some pretty respectable weight loss metrics.
Annabel: Are you balancing how how you push the dose for assistant manufacturing capacity issues have been getting a lot of questions around that given the supply problems at current manufacturers have them with your own therapies right now so I.
Brian Lian: With respect to the overall market, yeah, it does seem like there is a rapid expansion of GLP-1 utilization, and so that probably does create some headwinds on the uptick of new NASH drugs, but we've not had an approved drug for NASH. So now that we have it, I think it's going to be really important to see how the first few quarters mature there. And maybe there is a backlog of people waiting to try it and a backlog of clinicians waiting to prescribe it. So, so unknown right now, it's hard to project. But it is true that GLP-1s are getting more and more utilization.
Annabel: I just wanted to know if you're going into this with that thought in mind.
Annabel: And the second is.
Annabel: Is I guess, given some of the additional benefits that weight loss drugs are having whether its on CV risk or hypertension or kidney disease now sleep apnea.
Annabel: Are there any additional trials are subpopulations that you can be baking in to your later stage development programs to sort of positioning yourself.
Brian Lian: There's a middle question in there I think I skipped.
Kambizan: Yeah, just some plans for Phase 3 for your MASH program. I kind of intend to do it solo or maybe seek a partner.
Competitively.
Annabel: You know even at a minimum from a payer perspective.
Brian Lian: Yeah, yeah, great, yeah. So, what we plan to do is receive the data from the VOYAGE study, and then we'll schedule an end-of-phase 2 meeting with the FDA for later this year and get the current view of registration endpoints and any trial design suggestions the agency might have. I think we'll have to see what the data looks like, but we'll probably be looking for a partner with the program, but hard to say without having a look at the data first.
Annabel: Baseball.
Without having to do phase four trials, but at least have some kind of.
Annabel: D R. A metric in our late stage trials that youre already designing so those are my questions for now thanks Annabel for the second question.
Annabel: We'll probably focus mostly on obesity is the primary early indication, but all of the the subsets that you just mentioned and the successes.
Kambizan: Excellent. Thank you. I really appreciate the answers.
Operator: The next question comes from Annabel Samimy with Stiefel. Please go ahead.
Annabel Eva Samimy: Hi, thanks for taking my questions. I have two on the oral.
Annabel: In those populations are really important so too.
Annabel Eva Samimy: So when you think about the additional doses for the oral, which, you know, has already shown some pretty respectable weight loss metrics, how are you balancing how high you push the dose versus the manufacturing capacity issues? We're getting a lot of questions around that given the supply problems that current manufacturers have with their own therapies right now. So I just want to know if you're going into this with that thought in mind.
Annabel: To the extent, we could add a cohort.
Annabel: With the <unk>.
Annabel: Dyslipidemia or something like that to look at.
Annabel: Effects on plasma lipids that might have a read through to cardiovascular benefit that maybe were primarily though looking at the the weight loss indication for the phase III program with respect to.
Annabel: Manufacturing and scenario that we're acutely aware of it and.
Annabel: I think a couple of things we're right now in this very acute.
Annabel Eva Samimy: And the second is, I guess, given some of the additional benefits that weight loss drugs are having, whether it's CV risk or hypertension or kidney disease and now sleep apnea. Are there any additional trials or subpopulations that you can be baking into your later stage development programs to sort of position yourself competitively, you know, even from a payer perspective as this space evolves without having to, you know, do phase four trials but at least have some kind of idea or metric in the late stage trials that you're already designing? So those are my questions. Thanks, Jennifer.
Annabel: Stage, where these compounds have just been recently approved for weight loss and there is just overwhelming demand and the supply isn't quite there we don't consider that to be.
Annabel: Terminal state.
Annabel: We do see.
Annabel: From the existing comp.
Annabel: Companies in the space ramp up in manufacturing capacity, we know on the contractor side there is a.
Annabel: Massive attention being paid paid to this.
Annabel: This issue and so I think the supply dynamics will probably evolve over the next few years still going to be a difficult challenge, but I think.
Brian Lian: Thanks, Annabel. Yeah, for the second question, we'll probably focus mostly on obesity as the primary or early indication, but all of the subsets that you just mentioned and the successes in those populations are really important. So, to the extent, you know, we could add a cohort with the... Dyslipidemia, or something like that, to look at effects on plasma lipids that might have a read-through to cardiovascular benefit. We're primarily, though, looking at the weight loss indication for the Phase III program.
Annabel: We're not in a permanent shortage state we don't think.
Speaker Change: Okay, great. Thank you.
Speaker Change: The next question comes from Jay Olson with Oppenheimer. Please go ahead.
Jay Olson: Oh, Hey, congrats on all the progress and thank you for providing this update.
Jay Olson: For Q VK 2735, what kind of data should we expect into Q and do you think you'll have enough data to support less frequent dosing and then what are your latest thoughts on the phase <unk> study and then I had a follow up question if I could.
Brian Lian: With respect to manufacturing, it's an area that, yeah, we're acutely aware of. And, you know, I think a couple things. We're right now in this very acute stage where these compounds have just been recently approved for weight loss, and there is just overwhelming demand, and the supply isn't quite there. But we don't consider that to be a terminal state.
Speaker Change: Yeah. Thanks, Jay So will we.
Speaker Change: We haven't received the final data from the study yet so.
We would be looking for the lipid data some of the PK data the exposure data after.
Brian Lian: We do see, you know, from the existing companies in the space, a ramp-up in manufacturing capacity. We know on the contractor side, there is massive attention being paid to this, this issue, and so I think the supply dynamics will probably evolve over the next few years. Still going to be a difficult challenge, but I think we're not in a permanent shortage state. Okay, great.
Speaker Change: Four to six weeks after the last dose that that sort of thing I think would be important for us to understand and whats the proper forum for presentation.
Maybe some of it would trickle into earnings updates.
Speaker Change: Our corporate presentations, but probably later in the year, we would have a.
Speaker Change: A presentation at a medical conference.
Speaker Change: And.
Speaker Change: With respect to less frequent dosing I mean, thats part of the PK data that we will receive.
Speaker Change: You know if it looks like we're in a therapeutic range.
Annabel Eva Samimy: Okay, great. Thank you.
Operator: The next question comes from Jay Olson with Oppenheimer. Please go ahead.
Speaker Change: At some period after the last dose.
Jay Olson: Oh hey, congratulations on all the progress and thank you for providing this update. For sub-Q VK2735, what kind of data should we expect in 2Q? And do you think you'll have enough data to support less frequent dosing? And then what are your latest thoughts on a phase 2B study? And then I had a follow-up question.
Speaker Change: Maybe that will be a feasible.
Speaker Change: Our strategy and we would look to incorporate that into a subsequent trial, so really important data coming out of the <unk>.
Speaker Change: PK data.
Speaker Change: Dataset.
Speaker Change: Okay, great. Thanks, and latest thoughts on a phase III study.
Speaker Change: The phase <unk> study, yeah, we're going to have a type C meeting with the FDA later this quarter and so we would hope to be able to start.
Brian Lian: Yeah, thanks, Jay. So we'll, you know, we haven't received the final data from the study yet. So we would be looking for, you know, the lipid data, some of the PK data, the exposure data after, you know, four and six weeks after the last dose. That sort of thing, I think, would be important for us to understand and what the proper form for presentation would be. You know, maybe some of it would trickle into earnings updates or corporate presentations, but probably later in the year, we would have a presentation at a medical conference.
Speaker Change: The next study a phase <unk> study seems seems likely.
Speaker Change: We would look to start to that later in the year probably.
Speaker Change: Fourth quarter would be the timing for that study.
Speaker Change: Okay, great. Thanks, and if I could ask one more question given the positive data that you've already presented her both injectable and oral VK two 735, what additional cards would you like to turnover before seeking a partner or a potential strategic transaction.
Speaker Change: Well I think more data is always helpful to potential partners, but we don't view it as a.
Brian Lian: And with respect to less frequent dosing, I mean, that's part of the PK data that we will receive. You know, if it looks like we're in a therapeutic range, you know, at some period after the last dose, maybe that will be a feasible strategy, and we would look to incorporate that into a subsequent trial. So, really important data coming out of the PK dataset.
Speaker Change: Gating for us to have meaningful conversations.
Speaker Change: I'm not sure it's necessarily gating for others to have meaningful conversations with us but.
Speaker Change: Generally the larger partners like to see more data as programs evolved but again not a.
Jay Olson: Okay, great. Thanks. And what are your latest thoughts on a Phase 2B study?
Speaker Change: I don't think Thats, a mandatory requirement right now.
Speaker Change: Great. Thanks for taking all the questions.
Speaker Change: Thanks, a lot Jay.
Brian Lian: The Phase 2B study, yeah, we're going to have a type C meeting with the FDA later this quarter, and so we would hope to be able to start the next study. A Phase 2B study seems likely, but we would look to start that later in the year, probably the fourth quarter would be the timing for that study.
Speaker Change: The next question comes from Andrew <unk> with William Blair. Please go ahead.
Andrew: Okay, great guys. Thanks for taking our question.
Andrew: So the first of all I have is really.
Andrew: On the potential framework for duration for the phase II subcutaneous study.
Jay Olson: Okay, great. Thanks. And if I could ask one more question, given the positive data you've already presented for both injectable and oral VK2735, what additional cards would you like to turn over before seeking a partner or potential strategic transition?
Andrew: Maybe from two directions, one is really on maybe.
Andrew: Maybe the GOP talks.
Speaker Change: Maybe you could provide us with an update regarding how long you can base of this upcoming study based on all the <unk> done.
Speaker Change: To date, and then secondarily.
Brian Lian: Well, I think more data is always helpful to potential partners, but we don't view it as, you know, gating for us to have meaningful conversations, and I'm not sure it's necessarily gating for others to have meaningful conversations with us, but generally, the larger partners like to see more data as programs evolve, but again, I don't think that's a mandatory requirement right now.
Speaker Change: We'll see what the full question on how you view the importance of scene.
Speaker Change: Pretty consistent plateauing, just to get the maximum weight loss data.
Speaker Change: Just in terms of de risking program.
Speaker Change: Just to see the possibility.
Speaker Change: Yes, Thanks, Andy.
Jay Olson: Great. Thanks for taking all the questions. Thanks a lot, Jay.
Speaker Change: The plateau.
Operator: The next question comes from Andrew Shea with William Blair. Please go ahead.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: From what we've seen right now the phase two B studies that were performed with the <unk>.
Andrew Shea: Great. Thanks for taking our questions. So the first one I have is really on the potential framework for duration for the Phase II subcutaneous study, maybe from two directions. One is really on the GLP talks.
Speaker Change: <unk> had not plateaued prior to the registration studies being initiated so.
Andrew Shea: Maybe you can provide us with an update regarding how long you can boast of this upcoming study based on all the GLP talks that you've done to date. And then, secondarily, it's mostly like a philosophical question on how you view the importance of seeing a pretty consistent plateau just to get the maximum weight loss data. You know, just in terms of de-risking the program, is it important just to see the plateau?
Speaker Change: It's hard to.
Speaker Change: Hard to really know how the FDA will do.
Speaker Change: Judge the assessment of a plateau when the currently approved drugs did not reach that in there in their phase <unk> studies.
Speaker Change: So that's.
Speaker Change: That's one of the things, we hope to learn a little bit about in the upcoming type C meeting with the.
Speaker Change: Tox coverage, we were finished with the chronic tox. So we don't have a limitation.
Speaker Change: Toxicity wise or GOP Tox study limitation on duration, so we could.
Brian Lian: Yeah, thanks, Andy, for the plateau. You know, from what we've seen right now, the phase 2B studies that were performed with semaglutide and trizepatide had not plateaued prior to the registration studies being initiated. So it's hard to really know how the FDA will judge the assessment of a plateau when the currently approved drugs did not reach that in their phase 2B studies. So that's one of the things we hope to learn a little bit about at the upcoming type C meeting.
Speaker Change: Doses lines, we'd like and I think probably six months or nine months would be the two most likely candidates for duration of the phase II.
Speaker Change: Got it that's helpful. Since we're talking about.
Speaker Change: A discussion with the FDA I'm just curious if you have any.
Speaker Change: Lingering question Youre actually items I'd like to discuss with the agency.
Brian Lian: With the tox coverage, we're finished with the chronic tox, so we don't have a limitation toxicity-wise or GLP tox study limitation on duration, so we could dose for as long as we'd like. And I think probably six months or nine months would be the two most likely candidates for duration of phase 2B.
Speaker Change: Around midyear.
Speaker Change: Oh well.
Speaker Change: We're not going to disclose the nature of the conversations but we're interested in study design and duration.
Speaker Change: Well.
Speaker Change: Going back to your question about.
Speaker Change: Understanding that the ideal duration prior to phase III.
Andrew Shea: Got it. That's helpful. Since we're talking about the upcoming discussion with the FDA, I'm just curious if you have any, you know, lingering questions or action items you'd like to discuss with the agency around mid-year.
Speaker Change: Those are those are all key questions.
Speaker Change: Okay.
Speaker Change: Got it Okay, and then lastly, the can.
Speaker Change: Panics.
Speaker Change: Obviously a.
Speaker Change: Expecting Nash data coming up.
Speaker Change: So curious if there is any sort of procedural things that we should anticipate.
Brian Lian: Oh, well, uh... We're not going to disclose the nature of the conversations, but we're interested in study design and duration, and going back to your question about understanding the ideal duration prior to phase three. So those are all key questions.
Speaker Change: I know what the IP dispute there.
Speaker Change: Yeah. So we would expect a ruling on the dispute sometime.
Speaker Change: This quarter.
Andrew Shea: Got it. Okay. And then lastly, the GANIX dispute, obviously, we're expecting NASH data coming up. So, I'm curious if there are any sort of procedural things that we should anticipate with the IP dispute there.
Speaker Change: But.
Speaker Change: Hard to speculate since it's <unk>.
Speaker Change: Ongoing litigation.
Speaker Change: Got it.
Speaker Change: Great. Thanks for taking all of our questions.
Speaker Change: Thanks, a lot Andy.
Speaker Change: The next question comes from Steve seed Health with Raymond James. Please go ahead.
Brian Lian: Yeah, so we would expect a ruling on that dispute sometime this quarter, but it's hard to speculate since it's ongoing litigation.
Speaker Change: Hi. Thank you this is Nick on for Steve.
Nick: We have a question related to animals on manufacturing are you able to specify what materials are factors are most scaling to ramp up commercial supply of two 735 and what this only be a potential issue for the higher doses of the oral formulation. Thank you.
Andrew Shea: Great. Thanks for taking all of our questions. Thanks a lot, Andy. The next question comes from Steve Seedhouse with Raymond James. Please go ahead. All right, thank you.
Nick: Okay.
Speaker Change: Yeah. Thanks, I think it's an issue for for all doses when we look at the.
Operator: The next question comes from Steve Seedhouse with Raymond James. Please go ahead. Hi, thank you. This is Nick on behalf of Steve.
Speaker Change: Currently approved drugs they are difficult to start because of shortages. So I think all doses it's relevant to.
Operator: We have a question related to animals.
Nick: Yeah, thanks. I think it's an issue for all doses. When we look at the currently approved drugs, they're difficult to start because of shortages. So I think all doses it's relevant to today.
Speaker Change: Today.
Speaker Change: With respect to overall, what is the where the greatest shortage I mean, they're throughout the supply chain solvents.
Brian Lian: With respect to overall, you know, where is the greatest shortage? I mean, they're throughout the supply chain, solvents, Smith. You know, whatever's needed for solid phase syntheses, fill, and finish materials. So it's pretty neat. Shortfall right now, but again, we don't think that's going to be a terminal state for this class of compounds. When you look at the market opportunity, the incentive is pretty high to figure out these problems.
Speaker Change: Whatever's needed for solid phase syntheses Phil.
Speaker Change: Fill and finish materials, so it's a pretty.
Speaker Change: Thorough.
Speaker Change: The shortfall right now, but again, we don't think Thats a.
Speaker Change: Going to be a terminal state.
Speaker Change: For this class of compounds.
Speaker Change: When you look at the market opportunity that incentive is pretty high to figure out these problems.
Operator: Again, if you have a question, please press star, then 1. The next question comes from Thomas Smith with Lee Rink Partners. Please go ahead.
Speaker Change: Again, if you have a question. Please press Star then one.
Speaker Change: The next question comes from Thomas Smith with Leerink Partners. Please go ahead.
Thomas Jonathan Smith: Hey guys, good afternoon.
Thomas Jonathan Smith: Hey, guys. Good afternoon, thanks for taking the questions.
Thomas Jonathan Smith: Thanks for taking the questions. Just ahead of the VOYAGE study readout, can you remind us what your expectations are for the two histology endpoints, fibrosis improvement and NASH resolution? Can you comment on what data you expect to have available at the top line versus data sets that you expect to receive later or perhaps for presentation at a medical meeting?
Thomas Jonathan Smith: Just ahead of the voyage study readout can you.
Thomas Jonathan Smith: Remind us what your expectations are on the tumor histology endpoints fibrosis improvement and Nash resolution and.
Thomas Jonathan Smith: Can you comment on what data you expect to have available at the top line versus datasets that you expect to receive later or perhaps sitting for presentation at a medical meeting.
Brian Lian: Yeah, yeah, thanks, Tom. So on the hurdles, what we've always thought is if we can show a NASH resolution delta, you know, in that low to mid teens rate for treated versus placebo, and for the proportion of patients with a one-point improvement without worsening of NASH, similarly sort of low double digits, although with fibrosis, I would not be expecting statistical significance just because the numbers are smaller.
Speaker Change: Yeah, Yeah. Thanks, Tom so on the on the hurdles.
Speaker Change: We've always thought is if we can show a Nash resolution Delta.
Speaker Change: And that in that low to mid teens rate the FERC treated versus.
Speaker Change: Placebo and four the proportion of patients with a one point improvement without worsening of Nash.
Speaker Change: Similarly, sort of low double digits, although with fibrosis I would be.
Speaker Change: I would not be expecting statistical significance, just because the the.
Speaker Change: The numbers are smaller.
Speaker Change: But those would be the key.
Brian Lian: But those would be the key. [inaudible] Paired biopsy reads, you know, what is someone's NASH better, unchanged, or worse, you know, at the end of the treatment period, that kind of thing, since those take a little bit longer to evaluate.
Hurdles that were looking for with the dataset.
Speaker Change: With respect to what would be available and when will those are the primary components of the.
Data that we'll receive.
Speaker Change: We'll be receiving probably little later.
Speaker Change: Data on.
Speaker Change: Paired biopsy reads.
Speaker Change: As someone's Nash.
Speaker Change: Better.
Speaker Change: Unchanged or worse.
Speaker Change: At the end of the treatment period that kind of thing since those take a little bit longer to to evaluate.
Thomas Jonathan Smith: Understand that's helpful, and then just for Oral 2735, can you just clarify, do you expect to report data from the ongoing higher dose cohort once that's available, or is it possible that you could add some additional higher dose cohorts before we see any incremental data from this study?
Speaker Change: Understood. That's helpful and then just.
Speaker Change: For oral 20 735.
Speaker Change: Can you just clarify do you expect to report data from the ongoing higher dose cohort once that's available or is it possible that you could add some additional higher dose cohorts before we see any incremental data from from the study.
Brian Lian: Probably more of the latter, so we don't just kind of drip data out. We would probably want to report what we have when the study is completed, rather than cohort by cohort.
Speaker Change: But probably more of the latter so we don't just kind of dripped data out we would probably want to.
Speaker Change: Report, what we have when the study is completed.
Other than cohort by cohort.
Thomas Jonathan Smith: Got it, understood. All right, guys, thanks for taking the questions.
Speaker Change: Got it understood alright, guys. Thanks for taking the questions.
Speaker Change: Thanks, Tom.
Operator: The next question comes from Yale Jen with Laidlaw & Co. Please go ahead.
Speaker Change: The next question comes from Yale Jen with Laidlaw and co. Please go ahead.
Yale Jen: Good afternoon, and thanks for taking the question. Brian, you're talking about that 2735 will be presented at a medical conference later on. Just curious, anything in mind at this point that you are thinking?
Yale Jen: Good afternoon, and thanks for taking the question.
Yale Jen: Brian you were talking about that two.
Yale Jen: <unk> thousand 735 liter all will be presented at medical conferences.
Yale Jen: Curious anything in mind at this point that you are thinking.
Brian Lian: Yeah, thanks, Yale. Last year, we presented the phase one data at Obesity Week. And so that would seem like a good candidate. We haven't submitted anything, but it would seem like a good candidate for data presentation.
Yale Jen: Yeah. Thanks Neal.
Brian: Last year, we presented the phase one data at obesity week, and so that would seem like a good candidate we haven't submitted anything that that that would seem like a good candidate for data presentation.
Brian: Okay.
Brian: And.
Yale Jen: Okay, that's helpful. And a follow-up question here is that for the subcube version, there are two things. One is the autoinjector, are you guys already working on that? And secondly, is that do you anticipate any kind of bridging PK study in between before you go? Heading to a more pivotal question.
Speaker Change: A follow up question here is that.
Speaker Change: For the sub Q version.
Speaker Change: Do think that one is the auto injector.
Speaker Change: You guys are already working on that and then secondly is that.
Speaker Change: Do you anticipate any kind of bridging PK study.
Speaker Change: In between before you're.
Speaker Change: Heading to Mull pivotal studies.
Brian Lian: Yeah, great question, Yale; we will be using the pen-type device. And we would hope that it's available prior to the initiation of the next clinical study. But we're not going to let that be a gating factor. So if the device is not ready, we would plan to start the study with a violin syringe and then transition on to the auto injector.
Speaker Change: Yes, great question, Yale, we will be using the pen type device.
Speaker Change: We would hope that's available prior to initiation of the next clinical study, but we're not going to let that be a gating factor. So if the.
Yale Jen: The device is not ready we would plan to start the study with violence range in that transition.
Onto the <unk>.
Yale Jen: <unk> injector.
Yale Jen: But do you anticipate at one point whether you thought earlier, before that, or later that you need a bridging study for that, or do you think that PK data could be supported?
Speaker Change: But do you anticipate at one point what are your thoughts earlier before that or later.
Speaker Change: You need a bridge.
Speaker Change: <unk> study for that or using that PK data could be supported.
Brian Lian: Well, no, I don't think we would need a bridging study at this point. That's not what we're contemplating. I mean, if we have to do one, we would, but I don't think that's going to be a requirement. We would transition people.
Speaker Change: Well no I don't think we would need a bridging study at this point that's not that's not what we're contemplating I mean, if we have to do when we would but I don't think thats going to be a requirement we would transition people.
Yale Jen: Okay, great. Thanks, and congrats to all the participants this quarter.
Speaker Change: Okay, great. Thanks, and congrats on all the <unk>.
Speaker Change: This quarter, thanks, a lot yeah.
Operator: The next question comes from Justin Zelin with BTIG. Please go ahead.
Speaker Change: The next question comes from Justin <unk> with BTG. Please go ahead.
Justin Reid Zelin: Thanks for taking the questions and congratulations on the progress. Brian, you mentioned for the Voyage study for fibrosis that there might be a few patients here. Can you just remind us if the study is powered to show a difference in fibrosis in the study and have a follow-up?
Justin: Thanks for taking the questions and congrats on the progress Brian you just mentioned for the voyage study for fibrosis, you mentioned that there might be a few patients here can you just remind us if the study is powered to show.
Justin: A difference in fibrosis in the study.
Speaker Change: Follow up.
Brian Lian: Yeah, thanks, Justin. It wasn't powered on fibrosis. It was powered on Nash resolution rates, and I'm not sure we ever disclosed the power. It's in the 80% range to show approximately a 20% delta on Nash resolution, but it was not designed around fibrosis since that generally requires quite a bit larger end than we have in this study.
Brian: Yeah. Thanks, Justin it wasn't powered on fibrosis. It was powered on Nash resolution rates.
Speaker Change: <unk>.
Brian: I am not sure we ever disclosed to power its in the 80% range to show approximately a 20% Delta on Nash resolution.
Brian: But it was.
Brian: Not designed around fibrosis since that generally requires quite a bit larger and then we have in this study.
Justin Reid Zelin: And maybe I'll ask you, I don't think any others have asked yet, just expectations for 0214 for XALD, what would be a success here in your view for Phase 1b?
Justin: Understood that's helpful and maybe I'll ask you about I don't think any others have asked yet just expectations on a zero to one four for X a L. D. What would be a success here in your view for the phase IV.
Brian Lian: Yeah, yeah, so we have previously shown with that compound somewhere in the 20% range on, you know, LDL reduction and in the 20% range for ApoB and LbA, so we know it's effective at lipid reduction. And we also looked at very long-chain fatty acids in the healthy volunteers. It's kind of tough to look at because they're healthy volunteers.
Speaker Change: Yes, yes. So we have previously shown with that compound somewhere in the in the 20% range on.
Justin: LDL reduction.
In the 20% range for applebee and there'll be the law. So we know it's effective.
Justin: At lipid reduction and we also looked at very long chain fatty acids in the healthy volunteers, it's kind of tough to look because they are there.
Justin Reid Zelin: They don't really have abnormalities in very long-chain fatty acids, but we did see some reductions in very long-chain fatty acids in the prior phase one experience. So if we can see somewhere in the, you know, mid to high teens on the very long chain fatty acid reduction, that would be pretty interesting, hopefully more than that. But that would probably be the gating factor to consider further development in X-linked adrenolith dystrophy.
Justin: Healthy volunteers, they don't really have abnormalities in very long chain fatty acids, but we did see some reductions in very long chain fatty acids in the prior phase one experience so.
Justin: If we can see somewhere in the mid to high teens on the very long chain fatty acid reduction that would be a pretty interesting hopefully more than that but that would be probably the.
Justin: The gating factor to consider further development and excellent to drill it's dystrophy.
Brian Lian: Excellent. Thanks for taking my question.
Speaker Change: Excellent thanks for taking my questions.
Operator: This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.
Speaker Change: Thanks, Jonathan.
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.
Stephanie Diaz: Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a good afternoon.
Stephanie Diaz: Thank you again for your participation and continued support of Viking Therapeutics, we look forward to updating you again in the coming months have a good afternoon.
Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Sure.
Yes.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Yes.