Q4 2023 Viking Therapeutics Inc Earnings Call
Welcome to the Viking Therapeutics fourth quarter and full year 2023 financial results conference call.
Operator: Welcome to the Viking Therapeutics fourth quarter and full year 2023 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 session. To ask a question at that time, please press the star key followed by one on your touchtone phone.
At this time all participants are in a listen only mode.
Following managements prepared remarks, we will hold a question and answer session.
To ask a question at that time. Please press the star key followed by one on your Touchtone phone.
Operator: If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference call is being recorded today, February 7th, 2024. I would now like to turn the conference over to the Vikings Manager of Investor Relations, Stephanie Diaz. Please go ahead.
If anyone has difficulty hearing the conference. Please press star zero for operator assistance.
As a reminder, this conference call is being recorded today February seven 2024.
I would now like to turn the conference over to Viking's manager of Investor Relations. Stephanie Diaz. Please go ahead.
Stephanie Diaz: Hello, and thank you all for participating in today's call. Joining me today is Brian Lien, 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 7, 2024, will contain forward-looking statements under the safe harbor provisions of the U.S. 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 adversely, and reported results should not be considered as an indication of future performance.
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 seven 2024 will contain forward looking statements under the safe Harbor provisions of the U S. Private Securities Litigation Reform Act of 1995, including statements about <unk> expectations regarding its development activities timelines.
Millstone.
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 Lein for his initial comments.
These forward looking statements speak only as of today's date and the company undertakes no obligation to revise or update any statements made today I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters I'll now turn the call over to Brian Lian for his initial comments.
Brian Lien: Thanks, Stephanie, and good afternoon to everyone dialed in by phone or listening on the webcast. Today, we'll review our financial results for the fourth quarter and full year ended December 31, 2023 and provide an update on recent progress with our clinical programs and operations. 2023 was an exciting year for Viking, highlighted by important data releases from two of our four clinical programs. With respect to our obesity program, during the year, we announced positive results from a first-in-human phase I clinical trial of VK2735, a dual agonist of the GLP-1 and GIP receptors. In this study, subjects dosed with VK2735 demonstrated statistically significant weight loss with favorable safety and tolerability. Following these results, we initiated a Phase 2 trial, called Venture, to further evaluate VK2735 in patients with obesity. We expect to report top-line results from this study later this quarter. Additionally, during the year, we initiated a Phase I clinical trial evaluating an oral formulation of VK2735. We expect to report results from this study later this quarter. Viking made good progress with other pipeline programs during the year as well.
Thanks, Stephanie and good afternoon to everyone dialed in by phone or listening on the webcast.
Today, We'll review our financial results for the fourth quarter and full year ended December 31 2023.
Provide an update on recent progress with our clinical programs and operations.
2023 was an exciting year for Viking highlighted by important data releases from two of our four clinical programs.
With respect to our obesity program during the year, we announced positive results from our first in human Phase one clinical trial of VK. Two 735, a dual agonist of the G. L. P. One N G IP receptors.
In this study subjects dosed with VK, two 735 demonstrated statistically significant weight loss with favorable safety and Tolerability.
Following these results we initiated a phase II trial called venture to further evaluate VK 2735 in patients with obesity.
We expect to report top line results from this study later this quarter.
During the year, we also initiated a phase one clinical trial evaluating evaluating an oral formulation of VK two 735.
We expect to report results from this study later this quarter.
<unk> made good progress with other pipeline pipeline programs during the year as well.
Brian Lien: In May, we announced positive top-line results from the Phase IIb voyage study of our thyroid hormone-receptive beta-agonist, VK2809, in patients with biopsy-confirmed non-alcoholic steatohepatitis and fibrosis. This trial met its primary endpoint, with patients receiving BK2809 demonstrating statistically significant reductions in liver fat, as well as other important measures compared with patients treated with placebo. We look forward to reporting the 52-week biopsy data from this study in the first half of 2024. On the financial side, we completed 2023 with a strong balance sheet, thanks to our continued diligence and managing expenses, along with a successful public offering of common stock, which resulted in gross proceeds of approximately $288 million.
In May we announced positive topline results from the phase <unk> voyage study of our thyroid hormone receptor beta agonist VK, two eight or nine in patients with biopsy confirmed nonalcoholic, Seattle hepatitis and fibrosis.
This trial met its primary endpoint with patients receiving VK, two eight or nine demonstrating statistically significant reductions in liver fat as well as other important measures compared with patients treated with placebo.
We look forward to reporting the 52 week biopsy data from this study in the first half of 2024.
On the financial side, we completed 2023 with a strong balance sheet. Thanks to our continued diligence in managing expenses along with the successful public offering of common stock, which resulted in gross proceeds of approximately $288 million.
Brian Lien: These funds will be used to support the continued advancement of our pipeline programs through multiple clinical milestones. I'll provide further details on our operations and development activities after we review our financial results for the fourth quarter and full year 2023. After that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer. Thanks, Brian.
These funds will be used to support the continued advancement of our pipeline programs through multiple clinical milestones.
I'll provide further details on our operations and development activities. After we review our financial results for the fourth quarter and full year 2023.
For that I'll turn the call over to Greg Zante, Viking's, Chief Financial Officer.
Yes.
Thanks, Brian.
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 today. I'll now go over our results for the fourth quarter and full year ended December 31st, 2023, beginning with the results for the quarter. Our research and development expenses for the three months ended December 31st, 2023 were $20.5 million, compared to $16.2 million for the same period in 2022.
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 today.
I'll now go over our results for the fourth quarter and full year ended December 31, 2023, beginning with the results for the quarter.
Our research and development expenses for the three months ended December 31, 2023 were $25 million compared to $16 2 million for the same period in 2022.
Greg Zante: The increase was primarily due to increased expenses related to clinical studies and preclinical studies. Manufacturing for our drug candidate. Stock Base Compensation, Salaries, and Benefits, and third-party consultants. Our general and administrative expenses for the three months ended December 31, 2023, were $8.8 million compared to $4.1 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and third-party consultants, partially offset by decreased expenses related to salaries and benefits.
The increase was primarily due to increased expenses related to clinical studies.
Preclinical studies.
Manufacturing for our drug candidates stock based compensation salaries and benefits and third party consultants.
Our general and administrative expenses for the three months ended December 31, 2023 were $8 8 million compared to $4 1 million for the same period of 2022.
The increase was primarily due to increased expenses related to legal and patent services.
<unk> based compensation and third party consultants harsher.
Partially offset by decreased expenses related to salaries and benefits.
Greg Zante: For the three months ended December 31st, 2023, Viking reported a net loss of $24.6 million, or $0.25 per share, compared to a net loss of $19.6 million, or $0.26 per share, in the corresponding period in 2022. The increase in net loss for the three months ended December 31st, 2023, 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 2022. I'll now go over the results for the 12 months ended December 31st, 2023. Our research and development expenses for the year ended December 31st, 2023 were $63.8 million compared to $54.2 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, stock-based compensation, manufacturing for our drug candidates, Salaries and Benefits, and services provided by third-party consultants, partially offset by decreased expenses related to clinical studies. Our general and administrative expenses for the year ended December 31st, 2023, were $37 million, compared to $16.1 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, third-party consultants, and salaries and benefits.
For the three months ended December 31, 2023, Viking reported a net loss of $24 6 million or 25 cents per share compared to a net loss of $19 6 million or 20, <unk> 26 per share in the corresponding period in 2022.
The increase in net loss for the three months ended December 31, 2023 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously <unk>.
Partially offset by increased interest income compared to the same period in 2022.
I will now go over the results for the 12 months ended December 31 2023.
Our research and development expenses for the year ended December 31, 2023 were $63 8 million compared to $54 2 million for the same period in 2022.
The increase was primarily due to increased expenses related to preclinical studies stock based compensation manufacturing for our drug candidates salaries and benefits and services provided by third party consultants.
Partially offset by decreased expenses related to clinical studies.
Our general and administrative expenses for the year ended December 31, 2023 were $37 million compared to $16 1 million for the same period in 2022.
The increase was primarily due to increased expenses related to legal and patent services stock based compensation third party consultants and salaries and benefits.
For the year ended December 31, 2023, Viking reported a net loss of $85 9 million or <unk> 91 per share compared to a net loss of $68 9 million or <unk> 90 per share in the corresponding period in 2022.
Greg Zante: For the year ended December 31, 2023, Viking reported a net loss of $85.9 million, or $0.91 per share, compared to a net loss of $68.9 million, or $0.90 per share, for the corresponding period in 2022. The increase in net loss for the year ended December 31, 2023 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 2022. Turning to the balance sheet, at December 31st, 2023, Viking held cash, cash equivalents, and short-term investments of $362 million compared to $155 million as of December 31st, 2022. This concludes my financial review, and I'll now turn the call back over to Brian.
The increase in net loss for the year ended December 31, 2023 was primarily due to the increase 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 2022.
Turning to the balance sheet at December 31, 2023, Viking held cash cash equivalents and short term investments of $362 million compared to $155 million as of December 31, 2022.
This concludes my financial review and I'll now turn the call back over to Brian.
Thanks, Greg.
As I mentioned in my opening comments in 2023, Viking made significant progress with each of our four clinical programs positioning the company for an exciting year ahead.
I'll now briefly review, our 2023 accomplishments and preview key objectives for 2024.
I'll begin with an update on our VK two 730 <unk> program for obesity VK. Two 735 is viking's newest clinical stage compound and is a dual agonist of the glucagon like peptide one or G. L. P. One receptor and the glucose dependent insulin are trophic polypeptide or G IP receptor and.
Greg Zante: Thanks, Greg. As I mentioned in my opening comments, in 2023, Viking made significant progress with each of our four clinical programs, positioning the company for an exciting year ahead. I'll now briefly review our 2023 accomplishments and preview key objectives for 2024. I'll begin with an update on our BK2735 program for obesity. VK2735 is Viking's newest clinical stage compound and is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor, and the Glucose Dependent Insulinotropic Polypeptide or GIP response. In the first quarter of 2023, we announced positive results from a phase one single ascending dose and multiple ascending dose study of VK2734. This study was designed to evaluate the compound's initial safety, tolerability, and pharmacokinetic profile, as well as its potential impact on exploratory metabolic measures, including body weight and liver function. The single ascending dose portion of the study enrolled healthy men and women and demonstrated that single subcutaneous doses of VK2735 were safe and well-tolerated and displayed favorable pharmacokinetics. VK2735 demonstrated a half-life of approximately 170 hours to 250 hours and excellent therapeutic exposure.
In the first quarter of 2023, we announced positive results from a phase one single ascending dose and multiple ascending dose study of VK two 735.
This study was designed to evaluate the compounds initial safety tolerability and pharmacokinetic profile as well as its potential impact on exploratory metabolic measures, including body weight and liver fat.
The single ascending dose portion of the study enrolled healthy men and women and demonstrated that single subcutaneous doses of VK, two 735 were safe and well tolerated and displayed favorable pharmacokinetics.
VK two to 705 demonstrated the half life of approximately 178 hours to 250 hours and excellent therapeutic exposures.
The multiple ascending dose portion of this study enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter squared.
These subjects received subcutaneous doses of VK two 735 once weekly for 28 days.
As in the single ascending dose study the multiple ascending dose study demonstrated an encouraging safety and tolerability and positive signs of clinical activity.
All cohorts, receiving VK 2735 demonstrated reductions in mean body weight from baseline ranging up to seven 8%.
Cohorts, receiving VK two to 705 also demonstrated reductions in body weight relative to placebo ranging up to 6%.
Statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow up time point 21 days after the last dose of VK two 735 was administered.
With respect to safety and Tolerability, 98% of observed adverse events in the multiple ascending dose portion of the study were reported as mild or moderate and 99% of gastrointestinal related adverse events were reported as mild or moderate.
Brian Lien: The multiple ascending dose portion of this study enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter squared. These subjects received subcutaneous doses of VK2735 once weekly for 28 days. As in the single ascending dose study, the multiple ascending dose study demonstrated encouraging safety and tolerability and positive signs of clinical activity. All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in body weight relative to placebo, ranging up to 6%. Moreover, statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow-up time point, 21 days after the last dose of VK2735 was administered. With respect to safety and tolerability, 98% of observed adverse events in the multiple ascending dose portion of the study were reported as mild or moderate, and 99% of gastrointestinal-related adverse events were reported as mild or moderate.
This study also demonstrated VK 273, fives encouraging impact on liver fat and plasma lipids, specifically after four weekly subcutaneous doses of VK two 785 subjects in the phase one trial reported liver fat reductions of up to 47% from baseline.
Among subjects with nonalcoholic fatty liver disease placebo adjusted reductions in liver fat reached approximately 59%.
These results indicate VK 273, fives potential benefit in patients with various forms of fatty liver disease.
With respect to plasma lipids treatment with VK, two 735 produced encouraging reductions from baseline in total cholesterol of up to 21% and reductions in LDL cholesterol of up to 23% plan.
Plasma levels of April LIFO protein D were also reduced by up to 21%.
These data are particularly interesting in light of the fact that these healthy volunteers began the study with normal baseline plasma lipid levels.
These study results were featured in an oral presentation last October at obesity week and served as the basis for our decision to continue to advance this program further clinical development.
To this end in the third quarter of last year Viking initiated the phase two venture trial to evaluate decay to 705 in patients with obesity.
The venture trial is a randomized double blind placebo controlled multicenter study that is evaluating the safety tolerability pharmacokinetics and weight loss efficacy of VK. Two 735 administered subcutaneously once weekly for 13 weeks.
Brian Lien: This study also demonstrated DK2735's encouraging impact on liver fat and plasma lipids. Specifically, after four weekly subcutaneous doses of VK2735, subjects in the Phase I trial reported liver fat reductions of up to 47% from baseline. Among subjects with non-alcoholic fatty liver disease, placebo-adjusted reductions in liver fat reached approximately 59%.
This trial was designed to enroll approximately 125 adults with obesity or adults, who are overweight with at least one weight related comorbidity condition.
Due to higher than expected clinician and patient interest. This trial's enrollment was increased to 176 patients and completed ahead of schedule.
The venture trial is evaluating weekly subcutaneous doses of VK, two 735 of up to 15 milligrams compared to the 10 milligram top dose evaluated in the prior phase one multiple ascending dose study.
Brian Lien: These results indicate VK2735's potential benefit in patients with various forms of fatty liver disease. With respect to plasma lipids, treatment with VK2735 produced encouraging reductions from baseline in total cholesterol of up to 21% and reductions in LDL cholesterol of up to 23%. Plasma levels of apolipoprotein B were also reduced by up to 21%.
The primary endpoint of the study will assess the percent change in body weight from baseline to week 13, among patients treated with VK, two 735 as compared with placebo.
Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.
We expect to report the topline results from this study in the first quarter of this year.
In addition to the subcutaneous formulation of VK 2735 in the first quarter of last year Viking announced the initiation of a phase one clinical study evaluating a novel tablet formulation of this molecule.
Brian Lien: These data are particularly interesting in light of the fact that these healthy volunteers began the study with normal baseline plasma lipids. These study results were featured in an oral presentation last October at Obesity Week and served as the basis for our decision to continue to advance this program further in clinical development. To this end, in the third quarter of last year, Viking initiated the Phase II Venture Trial to evaluate VK2735 in patients with obesity. The Venture Trial is a randomized, double-blind, placebo-controlled, multi-center study that is evaluating the safety, tolerability, pharmacokinetics, and weight loss efficacy of BK2735 administered subcutaneously once weekly for 13 weeks. This trial was designed to enroll approximately 125 adults with obesity or adults who are overweight with at least one weight-related comorbid condition.
This study is an extension of the phase one single ascending dose and multiple ascending dose study discussed a moment ago.
The oil portion of the study is a randomized double blind placebo controlled study in healthy volunteers, who have a minimum body mass index of 30 kilograms per meter square.
Subjects in this portion of the study will receive once daily oral doses of VK two 735 for 28 days the primary.
Objective of the studies to evaluate the safety Tolerability and pharmacokinetics of VK. Two 735, following 28 28 days of oral dosing.
Exploratory endpoints include changes in body weight and other pharmacodynamic markers.
We expect to report the results from this study in the first quarter of this year.
I'll now provide an update on our VK two eight or nine program for the treatment of Nash and fibrosis.
VK two eight or 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 Lien: Due to higher than expected clinician and patient interest, this trial's enrollment was increased to 176 patients and completed ahead of schedule. The Venture trial is evaluating weekly subcutaneous doses of VK2735 of up to 15 mg compared to the 10 mg top dose evaluated in the prior Phase I multiple ascending dose study. The primary endpoint of the study will assess the percent change in body weight from baseline to week 13 among patients treated with VK2735 as compared with placebo. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.
Last may we announced positive topline results from the ongoing phase <unk> voyage study of VK, two eight or nine.
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 or nine in patients with biopsy confirmed Nash and fibrosis enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction as.
Well as F <unk> and F three fibrosis.
Brian Lien: We expect to report the top-line results from this study in the first quarter of this year. In addition to the subcutaneous formulation of VK2735, in the first quarter of last year, Viking announced the initiation of a phase one clinical study evaluating a novel tablet formulation of this molecule. This study is an extension of the Phase I Single Ascending Dose and Multiple Ascending Dose studies discussed a moment ago. The oral portion of the study is a randomized, double-blind, placebo-controlled study in healthy volunteers who have a minimum body mass index of 30 kilograms per meter squared.
As we reported in May This study successfully achieved its primary endpoint with patients receiving VK two INO nine demonstrating statistically significant reductions in liver fat content from baseline to week 12, as compared with placebo.
The median relative change from baseline in liver fat ranged from 38% to 55% among patients receiving VK two eight or nine.
Importantly, up to 85% of patients receiving VK Twitter nine experienced at least a 30% relative reduction in liver fat.
This level of efficacy is associated with a greater likelihood of histologic benefit in Nash.
Brian Lien: Subjects in this portion of the study will receive once-daily oral doses of VK2735 for 28 days. The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics of VK2735 following 28 days of oral dosing. Exploratory endpoints include changes in body weight and other pharmacodynamic markers.
As in prior studies VK Twitter nine treated patients also achieved statistically significant reductions in LDL cholesterol triglycerides and atherogenic proteins.
We believe these results indicate that VK, two eight or nine has the potential to provide long term cardiovascular benefits.
The initial voyage data also served to further establish VK Twitter nine's promising safety and Tolerability profile.
Brian Lien: We expect to report the results from this study in the first quarter of this year. I'll now provide an update on our VK2809 program 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.
94% of treatment related adverse events among patients receiving VK, two eight or nine were reported as mild or moderate.
Discontinuation due to adverse events were low and balanced among placebo and treatment arms in particular Dk Twitter nine demonstrated excellent gastrointestinal tolerability.
In the voyage study the rates of nausea, diarrhea, stool frequency and vomiting were similar among VK, two eight or nine treated patients compared to placebo.
Brian Lien: Last May, we announced positive top-line results from the ongoing Phase 2b Voyage Study of VK2809. 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 content as measured by magnetic resonance imaging proton density fat fraction, as well as F2 and F3 fibrosis.
In November Viking presented new data from this study at the annual meeting of the American Association for the study of liver diseases. These new data demonstrated robust liver fat reductions among patients with or without type two diabetes as well as those having F two or F. Three fibrosis.
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 reported among patients without type two diabetes.
These data suggest that activation of the thyroid hormone beta receptor remains effective at reducing liver fat and the presence of an important metabolic comorbidity, commonly observed in patients with Nash.
Brian Lien: As we reported in May, this study 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. The median relative change from baseline to liver fat ranged from 38% to 55% among patients receiving BK2809. Importantly, up to 85% of patients receiving VK-2809 experienced at least a 30% relative reduction in liver fat. This level of efficacy is associated with a greater likelihood of histologic benefit in that
Treatment with VK Twitter nine also demonstrated potent reductions in liver fat among patients with F two or F. Three fibrosis.
Thus neither the presence of type two diabetes, nor the presence of F. Two or three fibrosis meaningfully impacted VK two airlines efficacy in reducing liver fat.
As Steatosis and LIFO toxicity are believed to be underlying drivers in Nash. These results suggest important long term benefits across key subgroups.
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 in the first half of 2024.
Brian Lien: As in prior studies, VK2809-treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides, and atherogenic proteins. We believe these results indicate that VK2809 has the potential to provide long-term cardiovascular benefits. The initial voyage data also served to further establish VK2809's promising safety and tolerability.
Moving to our orphan disease program, our second thyroid hormone receptor beta agonist VK 0214 is currently being evaluated in a phase one b trial in patients with X linked Adrenoleukodystrophy or X L D.
Like VK, two eight or nine VK owed to one four is also an orally available small molecule that is selective for the beta isoform of the thyroid hormone receptor.
<unk> is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of the peroxisome will transporter of very long chain fatty acids.
Brian Lien: 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. In particular, VK-2809 demonstrated excellent gastrointestinal tolerability. In the VOYAGE study, the rates of nausea, diarrhea, stool frequency, and vomiting were similar among VK2809-treated patients compared to placebo. In November, Viking presented new data from this study at the annual meeting of the American Association for the Study of Liver Disease. These new data demonstrated robust liver fat reductions among patients with or without type 2 diabetes, as well as those having 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 reported among patients without type 2 diabetes.
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 that sale.
In a prior phase one study VK owed to one four demonstrated dose dependent exposures no evidence of accumulation and the half life consistent with anticipated once daily dosing.
Subject to receiving VK 0214 experienced reductions in LDL cholesterol triglycerides April LIFO protein B and LIBOR protein a.
VK 0214 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.
The ongoing phase <unk> study of VK owed to one four is being conducted in patients with the adrenal Mylan neuropathy or a M and form of X L. D, which is the most common form of the disorder.
This trial is a randomized double blind placebo controlled multicenter study in adult male patients with Amgen.
Brian Lien: These data suggest that activation of the thyroid hormone beta receptor remains effective at reducing liver fat in the presence of an important metabolic comorbidity commonly observed in patients with NAS. Treatment with VK-2809 also demonstrated potent reductions in liver fat among patients with F2 or F3 fibrosis. Thus, neither the presence of type 2 diabetes nor the presence of F2 or F3 fibrosis meaningfully impacted BK2809's efficacy in reducing the risk. As steatosis and lipotoxicity are believed to be underlying drivers in NASH, these results suggest important long-term benefits across key subgroups. 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 in the first half of 2020. Moving to our Orphan Disease Program, our second thyroid hormone receptor beta agonist, VKO214, is currently being evaluated in a Phase 1B trial in patients with 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.
The primary objectives of the study are to evaluate the safety Tolerability and pharmacokinetics of VK owed to one four 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.
We expect to report the topline results from this study in the first half of 2024.
In conclusion, 2023 was an exciting and productive year for Viking with the company achieving significant progress with each of our clinical programs.
During the year, we reported the results from the first phase one trial of VK, two 735, which demonstrated early signals of efficacy as well as promising safety and Tolerability.
We also initiated the phase one clinical evaluation of a novel oral formulation of VK two 735.
Which we believe may expand the market opportunity for this compound.
In the fall of 2023, we initiated and completed the Upsized enrolment of the venture phase II trial to evaluate VK, two 730 fives longer term clinical benefit in patients with obesity.
We look forward to reporting the results from the venture Phase II study later this quarter along with the phase one data from the oral formulation study.
We also look forward to reporting data from the voyage phase <unk> study of our thyroid beta receptor agonist V. K O two to 809 in biopsy confirmed Nash and fibrosis.
The initial data from this study successfully achieved the primary endpoint and affirmed VK two <unk> best in class effect on liver fat along with its favorable tolerability and safety profile.
We expect to report the 52 week biopsy data from this study in the first half of 2024.
The phase <unk> study of VK 0214 for the treatment of adrenal Myeloneuropathy also continues and we look forward to announcing the results from this trial later in the first half.
Brian Lien: 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. In a prior Phase I study, VKO214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily doses. Subjects to received VKO214 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 reported, and no treatment or dose-related signals observed for GI side effects, vital signs, or cardiovascular malformations. The ongoing Phase 1b study of VKO214 is being conducted in patients with the This trial is a randomized, double-blind, placebo-controlled, multi-center study in adult male patients with AMS.
Finally, we completed 2023 with a strong balance sheet and our cash position that will support our objectives for 2024 and beyond.
All of US at Viking are optimistic about the year ahead, and we'd like to extend our thanks to our shareholders partners investigators and importantly, the patients participating in our clinical trials for their continued support.
This concludes our prepared comments for today. Thanks.
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 telephone keypad.
If you are using a speakerphone please pick up your handset before pressing the keys.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble the roster.
And our first question comes from Joon Lee of Truest. Please go ahead.
Brian Lien: 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. In conclusion, 2023 was an exciting and productive year for Viking, with the company achieving significant progress with each of its clinical programs. During the year, we reported the results from the first Phase I trial of VK2735, which demonstrated early signals of efficacy, as well as promising safety and tolerability.
Thanks for the update thanks for taking our questions.
Regarding the subcutaneous CK 275, you reminded us that.
Phase one you stopped 6% placebo adjusted weight loss in just four weeks, so with longer dosing of up to 13 weeks using up to 50% higher dose.
Seasonable expectation of weight loss in the upcoming to enter trial.
Yeah, Hey, John Thanks for the questions.
So.
We are really using around an 8% hurdle for the for the venture study.
I think if we showed that.
That would be sufficient for us to move forward.
I think it could be competitive at 13 weeks.
And just a quick follow up what are their safety and efficacy measures are you tracking.
We should be looking out for in debenture trial.
I'm, sorry, what other safety and what efficacy at guessing measures of efficacy.
Brian Lien: We also initiated the Phase I clinical evaluation of a novel oral formulation of VK2735, which we believe may expand the market opportunity for this compound. In the fall of 2023, we initiated and completed the upsized enrollment of the Venture Phase 2 trial to evaluate VK2735's longer-term clinical benefit in patients with obesity. We look forward to reporting the results from the Venture Phase 2 study later this quarter, along with the Phase 1 data from the oral formulation. We also look forward to reporting data from the Voyage Phase 2B study of our thyroid beta-receptor agonist, VK2809, in biopsy-confirmed NASH and fibrosis. The initial data from this study successfully achieved the primary endpoint and affirmed VK2809's best-in-class effect on liver fat, along with its favorable tolerability and safety profile.
Yeah, we're looking at obviously, a plasma lipids and we're looking at plasma glucose insulin standard battery of.
Of lab assessments and clinical chemistry.
Cardiovascular safety as well.
It's pretty pretty stand nothing unusual or exotic in the in.
In the safety analysis.
Great and then one last quick one.
The oral VK. Two 735 are you able to disclose whether you have those higher than 20 milligrams and that in this segment.
No, we're not going to get into the details of the.
The cohorts, we'll disclose all of those details when we disclose the data.
Alright, looking fortunate data thank you.
Thanks, a lot Jim.
The next question comes from Steven <unk> of Raymond James. Please go ahead.
Steven Your line is open.
Open are you made it.
Sorry about that guys can you hear me now.
Yes, we can't yet.
Brian Lien: We expect to report the 52-week biopsy data from this study in the first half of 2020. The Phase 1B study of VK0214 for the treatment of adrenal myoneuropathy also continues, and we look forward to announcing the results from this trial later in the first half. Finally, we completed 2023 with a strong balance sheet and a cash position that will support our objectives for 2024 and beyond.
Sorry, My apologies I appreciate you taking the question I wanted to first ask about venture for.
So the higher dose arms, particularly the 15 milligram co.
Cohort.
If you were just following that turns appetite titration schema like two five milligrams titrated.
In this case every three weeks you still wouldn't get to the high dose. So I'm curious if you can just clarify like what are the dose increments.
Sort of schema for the titration.
In that study.
Brian Lien: All of us at Viking are optimistic about the year ahead and would like to extend our thanks to our shareholders, partners, investigators, and importantly, the patients participating in our clinical trials for their continued support. 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 and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the key.
Yeah, we use a three week blocks.
The lowest dose is two and a half migs for 13 weeks. The second dose is two and a half migs for three weeks and then five migs for 10 weeks.
The.
10 milligram dose is two and a half for three weeks five for three weeks.
And then.
10 four.
Seven weeks.
And then the 15 milligram dose starts at five so it's.
Five milligrams for three weeks seven five milligrams for three weeks 10 milligrams for three weeks and then 15 milligrams for four weeks.
Joon Lee: To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble the roster. And our first question comes from Joon Lee of Truist. Please go ahead. Thanks for the update and for taking our questions. Regarding subcutaneous VK2735, you reminded us that in phase 1, you stopped 6% placebo-adjusted weight loss in just 4 weeks. So with longer dosing of up to 13 weeks using up to 50% higher doses, what's a reasonable expectation of weight loss in the coming weeks? Yeah, hey, Joon.
Perfect.
I appreciate that detail and then.
Just wanted to ask also is that there's a four week follow up period in this study off drug and I'm curious if that's a waiting for that four week off drug follow up to conclude before.
Analyzing the topline data or would the release just include the 13 weeks on drug.
Well, yes, it's a good question. It's a six week follow up period I might evolve earlier said four weeks mistakenly but you had a six week follow up window and.
I believe we will be through that when we report the top line data.
Okay.
Brian Lien: Thanks for the questions. So we're really using around an 8% hurdle for the venture study. I think if we showed that, that would be sufficient for us to move forward. I think it could be competitive at 13 weeks. And just a quick follow-up, what other safety and escape measures are you tracking that we should be looking out for in the venture?
I mean, I might as well be the first ask that is what is the sequencing of the sub Q and the oral data, which comes first or would they be announced together.
Oh, yes, thanks, Steve no not not going to be announced together and.
They'll both be this quarter I think that's about all the granularity we're going to give the quarters not very long.
Thanks, so much.
Brian Lien: Efficacy, efficacy measures. Oh, efficacy. Yeah, we're looking at, obviously, plasma lipids. We're looking at plasma glucose, insulin, a standard battery of lab assessments and clinical chemistry, cardiovascular safety as well. But it's pretty standard, nothing unusual or exotic in the safety analysis.
Thanks, Steve.
The next question comes from Jay Olson of Oppenheimer. Please go ahead.
Oh, Hey, congrats on the progress and thanks for that.
Hum.
Can you just talk about for the oral phase one data.
Since you have the option to add cohorts.
Brian Lien: And then one last quick one for the oral VK2735, are you able to disclose whether you've dosed higher than 20 milligrams? No, we're not going to get into the details of the cohorts. We'll disclose all of those details when we disclose the data. Looking forward to Zeta. Thanks a lot, Joon. The next question comes from Steven Seedhouse of Raymond James. Please go ahead. Steven, your line is open. Are you muted on your end?
How many cohorts of data should we expect.
Hi, Jay Thanks for the question yet.
<unk> to June we're not going to get into the details of the numbers of cohorts until we actually released the data.
The trial was originally designed to enroll four cohorts, but we maintain flexibility to add cohorts, but we'll have all the details on that when we release the data.
Okay, great. Thank you.
Steven Seedhouse: Sorry about that, guys. Can you hear me now? Yes, we can. Oh, sorry; my apologies. I appreciate you taking the question. With Venture, for the higher dose arms, particularly the 15 milligram cohort, if you were just following the terzapatide titration schema, like two and a half milligrams titrated, in this case, every three weeks, you still wouldn't get to the high dose. So I'm curious if you can just clarify, like, what are the dose increments and sort of scheme for the titration in that study. Yeah, we use three-week blocks. The lowest dose is two and a half migs for 13 weeks. The second dose is 2.5 mg for 3 weeks and then 5 mg for 10 weeks. The 10 milligram dose is two and a half for three weeks, five for three weeks, and then Henn for seven weeks.
And then I guess.
<unk>.
Novo is planning to acquire catalysts can you just talk about your manufacturing plans and any impact you might expect this type of acquisition goes through.
Yeah. Thanks, good question.
Shouldn't impact us at all at least but definitely not in the near term and I don't believe in Cogs.
As far as future plans as well.
I think we're all set to supply.
All of the clinical studies that will be required to receive approval.
Okay, great. Thanks, and can you just talk big picture about the current landscape for oral weight loss drugs and.
Where do you think horrible.
<unk> will fit in the Grand scheme of the obesity landscape.
Yes, that's a big question, but.
Brian Lien: And then the 15 milligram dose starts at five. So it's 5 mg for 3 weeks, 7.5 mg for 3 weeks, 10 mg for 3 weeks, and then 15 mg for 4 weeks.
We're 20 years into the G. L P. One era and Theres one approved oral agent.
That's a very very difficult challenge that the industry faces.
Brian Lien: And then I just want to ask also, there's a four-week follow-up period in this study off-drug, and I'm curious if that's, are we waiting for that four-week off-drug follow-up to conclude before analyzing the top-line data, or would the release just include the 13 weeks on-drug? Well, yeah, it's a good question.
So.
We're working on a program we're excited about but it's very very difficult.
I think oral to have multiple different.
Commercial positions, one would be as a lead into.
Brian Lien: It's a six-week follow-up period. I might have earlier said four weeks mistakenly, but you have a six-week follow-up window, and I believe we'll be through that when we report the top-line data. Okay, and I might as well be the first to ask that, what is the sequencing of the sub-q and the oral data? Which comes first, or would they be announced together? Thanks. Oh, yeah, thanks, Steve. No, they're not going to be announced together. And they'll both be in this quarter.
To a sub Q therapeutic for someone who doesn't want to maybe start with an injection.
The second one would be in the maintenance setting and we think that's a really important setting because if you've come off a large amount of weight loss and you don't want to continue to take the sub Q transitioning to an oral would be potentially.
Potentially really attractive option.
And in that sense, you maybe wouldn't require the same level of efficacy as a sub Q to maintain.
Brian Lien: I think that's about all the granularity we're going to give you. The quarter's not very long. Thanks so much. Thanks, Steve. The next question comes from Jay Olson of Oppenheimer. Please go ahead.
Certain target body weight.
The other.
Potential opportunity would be in the temporary use you know you have an event coming up in six months or whatever and you want to lose some weight ahead of that and so you wouldn't necessarily need the magnitude of weight loss that could be provided by a sub Q.
Jay Olson: Oh, hey, congrats on the progress and thanks for the update. Can you just talk about the oral phase one data, since you have the option to add cohorts? How many cohorts of data should we expect?
Brian Lien: Hi Jay, thanks for the question. I mentioned to Joon we're not going to get into the details of the numbers of cohorts until we actually release the data. The trial was originally designed to enroll four cohorts, but we maintain the flexibility to add cohorts. But we'll have all the details on that when we release the data. Okay, great. Thank you. And then, I guess, since Novo is planning to acquire Catalan, can you just talk about your manufacturing plans and any impact you might expect if that acquisition goes through? Yeah, thanks. Good question. It shouldn't impact us at all, at least not in the near term, and I don't believe it as far as future plans are concerned as well.
Dosage form in or would be suitable there. So a lot of different opportunities. We see the sub Q is the meat of the market, but we see the oral opportunity as a really important incremental opportunity.
Great. Thank you so much for taking my question.
Thanks Jay.
Yeah.
The next question comes from Robyn of Maxim Group. Please go ahead.
Hi, everyone. Congrats on the progress in just a couple of questions for me. So you obviously have a very very busy first half with the phase to be voyage and the venture results.
If both studies were to succeed and you see what you want to see could you provide some color or context around how much it would cost or what it would take to advance these programs into the next clinical trial.
Brian Lien: I think we're all set to supply all of the clinical studies that would be required to receive approval. Okay, great. Thanks. And can you just talk big picture about the current landscape for oral weight loss drugs and where you think oral... drugs will fit in the grand scheme of the obesity landscape? Yeah, that's a big question, Jay. But, you know, we're 20 years into the GLP-1 era, and there's only one approved oral agent. That's a very, very difficult challenge that the industry faces. So, you know, we're working on a program we're excited about, but it's very, very difficult. I think orals have multiple different commercial positions; one would be as a lead-in to a sub-Q therapeutic for someone who doesn't want to maybe start with an injection.
Yes, they are obviously very large and expensive studies.
More than.
Easily more than 100 million per study, probably not going to give detailed guidance on that precise expenses of those studies, but.
Suffice to say I think everybody is aware. These are these are very expensive phase III programs.
Gotcha and now on your.
Injectable could you talk a little bit about the current I guess delivery mechanism is it just on patients.
Use of vial and syringe do you have like an auto injector or plans for like an auto injector device for your.
Your injectable is any of that in works.
Yes. It is the phase two venture study is using a violent syringe, but we will be using a different device in future studies.
Brian Lien: The second one would be in the maintenance setting, and we think that's a really important setting because if you come off a large amount of weight loss and you don't want to continue to take the sub-Q, transitioning to an oral would be a potentially really attractive option. In that sense, you maybe wouldn't require the same level of efficacy as a sub-Q to maintain a certain target body weight. I think the other potential opportunity would be for temporary use. You know, you have an event coming up in six months or whatever, and you want to lose some weight ahead of that, and so you wouldn't necessarily need the magnitude of weight loss that could be provided by a sub-Q program.
Is that something we might get an update on this year or was that something you might get an update on more than like 25.
We'll probably provide an update on that when we start the next study.
The timing of that is TBD.
Got it. Thank you thanks for taking my questions. Thanks, guys.
Sure.
The next question comes from Andy Shay of William Blair. Please go ahead.
Oh, great. Thanks for taking the question.
Congratulations on all the progress in 2023 and look forward to a very productive 2024.
A question about the oral administration.
Brian Lien: Q&A: Great, thank you so much for taking all the questions. Thanks Jay. The next question comes from Naz Rahman of Maxim Group. Please go ahead. Hi everyone.
If you look at the rebel says label there are some restrictions about tightening of the fill volumes of water I'm just curious about the.
Naz Rahman: Congratulations on the progress. And I have just a couple of questions for you. So obviously, you have a very, very busy first half with the Phase 2B voyage and the venture results. If both studies were to succeed and you see what you want to see, could you provide some color or context around how much it would cost or what it would take to advance these programs into the next clinical trial? Yeah, they're obviously very large and expensive studies, you know, more than, easily more than $100 million per study.
The the gastric absorption technology baked into the oral formulation.
Do you think that there is a potential that you could engineer wave east restriction.
Yeah, Thanks, Andy we havent disclosed the technology or anything regarding.
Patient behavior in their subject behavior in there in.
In the study we will discuss that when we when we disclose the data.
But.
I'll just say now per per many phase one trials. These people are fast it as they when they take their doses in the morning, but we haven't disclosed any additional requirements or suggestions.
Got it okay.
And then staying in the same <unk> feel obviously, there is an increase in interest and perhaps evaluation of clinical assets that could boost lean body mass.
Brian Lien: I'm probably not going to give detailed guidance on the precise expenses of those studies, but suffice to say, I think everybody's aware these are very expensive phase 3 programs. Gotcha. And now on your injectable, could you talk a little bit about the current delivery mechanism? Is it just patients use a vial and syringe?
Looking at the various honest deal recently so in your pipeline 50, 211, and obviously that has demonstrated potential for that so.
Curious about potentially any change in prioritization or perhaps increased external inbounds on that asset.
Brian Lien: Do you have an auto injector or plans for an auto injector device for your injectable? Is any of that in the works? Yes, it is. The Phase II Venture Study is using a violin syringe, but we will be using a different device in future studies. Is that something we might get an update on this year, or was that something we might get an update on more in the like 25s? We'll probably provide an update on that when we start the next study, and the timing of that is TBD. Got it. Thank you. Thanks for taking my questions. Thanks, Ned.
You can share with us.
Yeah. Thanks, Andy It's a it's an interesting question and you're right BK 500 to one one.
The most potent oral agent I believe that we've ever seen I mean, certainly to our knowledge. There is nothing more potent on the oral side.
And the hip fracture study, we saw very significant increases in lean body mass at all doses and a beautiful dose response, we report those data in 2017 and 18.
And.
Brian Lien: The next question comes from Andy Hsieh of William Blair. Please go ahead. Well, great. Thanks for taking the question and congratulations on all the progress in 2023, and I look forward to a very productive 2024. A question about oral administration. If you look at the Rebels' label, there are some restrictions about timing of the food and volume of the water. I'm just curious about the gastric absorption technology baked into the oral formulation.
To the extent our loss of muscle from these agents is clinically relevant.
<unk> maybe <unk>.
Adding muscle building agents could be.
Reasonable approach.
It's not clear that.
It is clinically relevant.
The change in lean body mass I know it sounds great and it's an easy clean story to tell but we do have some experience in muscle drugs and we have experience with what the FDA considers important.
Andy Hsieh: Do you think that there is a potential that you can engineer away these restrictions? Yeah, thanks, Andy. We haven't disclosed the technology or anything regarding patient behavior in their subject behavior in the study. We will discuss that when we disclose the data. But I'll just say now, in many phase one trials, these people are fasted when they take their doses in the morning, but we haven't disclosed any additional requirements or suggestions.
And it's not just increase in muscle mass.
So.
It is an interesting area we've got a.
Very potent compound, but the medical necessity as a little bit murky to us.
That's fair. Thank you very much and maybe last quick one in terms of R&D, a little uptick this quarter.
Thinking about.
How do you foresee that trend going forward. Thank you.
Hi, Andy I think R&D will go up a bit this year versus last year.
Brian Lien: Got it. Okay. And then, you know, staying in the same OVC field, obviously, there's an increase in interest and perhaps evaluation of clinical assets that could boost lean body mass, you know, looking at the Bursana deal recently. So in your pipeline, 5211, obviously, that has demonstrated potential for that. So I'm curious about, you know, potentially any change in prioritization or perhaps increased external inbounds on that asset that you can share with us. Yeah, thanks, Andy. It's an interesting question, and you're right. VK5211 is the most potent oral agent that we've ever seen. I mean, certainly to our knowledge, there's nothing more potent on the oral side.
Not radically but it will be up a bit focused on advancing all of our programs and assuming success. So.
I think you could think about it increasing a bit but not not way way up for sure.
Yeah.
Great I appreciate it thank you.
Thanks, Andy.
The next question comes from Thomas Smith of Leerink Partners. Please go ahead.
Hey, guys. Good afternoon, thanks for taking the questions.
One just.
Big picture, we've seen a obviously a very active environment and it seems like Theres a lot of strategic interest in the <unk> space can you just comment on.
What youre seeing on the business development front in terms of partnership interest on your programs, both obesity and Nash and just remind us how youre thinking about next steps.
Brian Lien: In the hip fracture study, we saw very significant increases in lean body mass at all doses and a beautiful dose response. We reported those data in 2017 and 2018. And, you know, to the extent that loss of muscle from these agents is clinically relevant, then maybe adding a muscle-building agent could be a reasonable approach.
Development across both programs.
Thanks, Tom.
We can't comment too much.
On that I would just say.
You are correct in saying that.
It's an active area and an area of high awareness I would say across the industry based on the.
Brian Lien: It's not clear that it is clinically relevant, the change in lean body mass. I know it sounds great, and it's an easy, clean story to tell, but we do have some experience with muscle drugs, and we have experience with what the FDA considers important, and it's not just an increase in muscle mass. It is an interesting area. We've got a very potent compound, but the medical necessity is a little bit murky to us. That's fair.
The magnitude of the success, we're seeing in the clinical benefit that these therapies provide so makes sense that there would be.
Interest from from potential partners.
We would.
Be happy too.
Engage in those discussions.
Got it that's helpful. Thanks, and then.
Maybe just one on voyage you mentioned, having just completed the last patient biopsies recently, maybe you could just remind us.
How youre thinking about evaluating those biopsies and voyage, whether using single pathologist or multi path review.
Brian Lien: Thank you very much. And maybe last quick one in terms of R&D, a little uptake this quarter. Just thinking about how do you foresee that trend going forward?
And.
Brian Lien: Thank you. Hi Andy, I think our R&D will go up a bit this year versus last year, not radically, but it will be up a bit, focused on advancing all of our programs and assuming success. Yeah, I think you could think about it increasing a bit, but not way, way up.
Just kind of walk us through the gating factors there to reporting the top line dataset.
Yeah. Thanks, so the biopsies or the slower element there.
It is a single reader that we're using and.
The single reader.
It goes to a second reader when there is a patient whose biopsy is right on the cusp of something like F two or three fibrosis or.
Brian Lien: Great. I appreciate it. Thank you. Thanks, Andy!
Thomas Smith: The next question comes from Thomas Smith of Lerank Partners. Please go ahead. Hey guys, good afternoon.
And Apple the activity score for the things like that go to a second reader and then the first and second reader must reach a consensus.
Brian Lien: Thanks for taking the questions. Maybe one just on the big picture, you know; we've seen an obviously very active environment, and it seems like there's a lot of strategic interest in the obesity space. Can you just comment on what you're seeing on the business development front in terms of partnership interest in your programs, both obesity and NASH, and just remind us how you're thinking about next steps in development across both programs. Thanks, Tom. We can't comment too much on that.
Before the final assessment of the slide is made.
I think we started the study really before the three reader approach had become.
More widely used and so that's why we have the single reader.
Got it that's helpful. Thanks for taking the questions.
Thanks, Tom.
The next question comes from Yale Jen of Laidlaw <unk> Company. Please go ahead.
Brian Lien: I would just say you're correct in saying that it's an active area and an area of high awareness, I'd say, across the industry, based on the magnitude of the success that we're seeing and the clinical benefit that these therapies provide. So it makes sense that there would be..., interests from potential partners, and we would be happy to engage in those discussions.
Good afternoon, and thanks for the questions.
Just two quick ones here the first is.
Given the reason Lilly reporting about the synergy Nash.
And you guys actually mentioned earlier in terms of our 2735 had a impact on the liver fat.
Brian Lien: Got it. That's helpful. Thanks. And then maybe just one on Voyage.
Brian Lien: You mentioned having just completed the last patient biopsies recently. Maybe you could just remind us how you're thinking about evaluating those biopsies in Voyage, whether you're using single pathologist or multi-path review, and just kind of walk us through the gating factors there for reporting the top-line data set. Yeah, thanks. So the biopsies are the slower element there. It is a single reader that we're using, and the single reader goes to a second reader when there's a patient whose biopsy is right on the cusp of something like F2 or F3 fibrosis or an AFLD activity score of F4, things like that go to a second reader. And then the first and second readers must reach a consensus before the final assessment of the slide is made. So, I think we started the study really before the three-reader approach had become more widely used, and so that's why we have the single-reader.
I Wonder what does.
I should know thought or any other things you guys were thinking off.
Sure.
Overall strategic.
Neal thinking.
Hey, yes. Thanks.
Not really.
We have our Nash program already and.
Not.
Interested at this point and really pursuing Nash with the.
VK $2 735 program I do think it's encouraging to see that the dual agonist mechanism appears to be effective.
Nash resolution I think that's exciting.
But.
We're going to stick with obesity for the time being with that program.
Okay, maybe one more follow up here, which is that.
And just recently published there and.
Brian Lien: Got it. That's helpful. Thanks for taking the questions. Thanks, Tom. The next question comes from Yale Jen of Leydon Company. Please go ahead. Good afternoon, and thanks for taking the questions. There are just about two quick ones here.
In Q1, 33 phase one eight.
Was there any is there any comment and thought that that will.
Fourth for the your programs as well.
Yeah. Good question.
Havent had a chance to to really get into the evaluation of those data is pretty fresh.
Yale Jen: The first is that given the recent Lilly reporting about the Synergy NASH data and you guys actually mentioned earlier that 2735 had an impact on liver fat, I wonder whether there are additional thoughts or any other things you guys were thinking of in your overall strategic planning or thinking? Hey Yale, thanks. Not really.
But.
Yes, I guess, we will.
We evaluate those data moving forward, but good.
Good question for Amgen.
Well, thanks, a lot and congrats on the progress and look for all the data is it.
Half of the year.
Thanks, a lot yeah.
The next question comes from Joe <unk> of H C. Wainwright. Please go ahead.
Brian Lien: We have a NASH program already and are not interested at this point in really pursuing NASH with the VK2735 program. I do think it's encouraging to see that the dual agonist mechanism appears to be effective at treating NASH. I think that's exciting.
Hey, guys. Good afternoon, thanks for taking the question.
So Brian first I just wanted to start at the back end of your question and answer commentary.
Maybe pushed the envelope a little bit on business development.
You said you'd be happy to engage in discussions and I was just curious if I may are you able to discuss the levels of maturities of any potential discussions that may be ongoing.
Brian Lien: But we're going to stick with obesity for the time being with that program. Okay, maybe one more follow-up here, which is that Amgen recently published their MG-133 phase one data. Are there any comments and thoughts that will, you know, engage your program as well? Yeah, no, good question. We haven't had a chance to really get into the evaluation of that data yet. It's pretty fresh.
Yes, John I wouldn't want to mischaracterize that statement or mislead or anything we've always been open to partnering discussions.
Since since day, one so we're always.
Opportunistically evaluating opportunity.
Yeah.
As presented to us so.
Brian Lien: But yeah, I guess we'll... evaluate those data moving forward, but good question for Amgen. Well, thanks a lot and congratulations on the progress and look for all the, Thanks a lot, Yale. The next question comes from Joe Pagentis of H.C. Wainwright. Please go ahead. Hey guys, good afternoon.
I can't really characterize that any discussions got it got it and then to the earlier question very earlier question was asked about venture.
I'll ask the same regarding the oral study and that is what do you consider the benchmark to success.
For the oral study, yes, we've always considered.
Joe Pagentis: Thanks for taking the question. So Brian, first, I just wanted to start at the back end of your question and answer commentary, maybe pushing the envelope a little bit on business development.
If it could look.
Well, obviously, it's a safety and PK and Tolerability study. So we will look for safety Tolerability and clean predictable PK profile.
Brian Lien: You said you'd be happy to engage in discussions. And I was just curious, if I may, are you able to discuss the levels of maturity of any potential discussions that may be ongoing? Yeah, Joe, and I wouldn't want to mischaracterize that statement or mislead or anything. You know, we've always been open to partnering discussions since day one. So we're always, you know, opportunistically evaluating opportunities, you know, whatever is presented to us, so we can't really characterize any discussions. Got it, got it.
On body weight if.
If we could look like a <unk>.
Injectable <unk> one after a month that would be I think encouraging and.
So what's the magnitude there, it's a little bit variable, but we look at 1% to 2% as being a.
Brian Lien: And then to the earlier question, a very earlier question was asked about venture. I'll ask the same question regarding the oral study, and that is, what do you consider the benchmark for the oral study? Yeah, we've always considered, you know, if it could look. On body weight, if it looked like an injectable GLP-1 after a month, that would be, I think, encouraging. So what's the magnitude there?
It's something that would probably warrants further development.
Okay very fair and then my last question. Obviously this goes into later 2024 and beyond are you willing to take any first passes now with regard to pivotal study plans or even designs.
Brian Lien: It's a little bit variable, but we look at 1% to 2% as being something that would probably warrant further development. Okay, very fair. And then my last question, obviously this goes into later 2024 and beyond. Are you willing to take any first passes now with regard? Pivotal. For obesity? For obesity, for NASH, in general. Yeah, yeah, yeah.
For for obesity for obesity for Nash.
General for the company.
Yeah, Yeah yeah.
With both of these programs, we plan to speak with the FDA following the data analysis.
Brian Lien: Yeah, with both of these programs, we plan to speak with the FDA following the data analysis. So we'd like to have a type C meeting with the FDA on the BK2735 program and outline potential next steps there. And then, with the NASH program, have an end of phase two meeting. And We know what the guidance is for both indications, but it would be nice to talk with the FDA to learn any recommendations or new comments that they have regarding trial design. But we do have a pretty good idea of what those trials will look like for the color.
We'd like to have a type C meeting with the FDA on the VK two 730, <unk> program and outlined potential next steps there and then with the.
The Nash program.
Have an end of phase II meeting and.
We know what the guidance is for both indications, but it would be nice to talk with the FDA to learn any any recommendations or.
New comments that they have regarding trial design, but we do have a pretty good idea on what those trials will look like.
Great. Thanks for the color Brian.
Brian Lien: The next question comes from Jack Padovano of Stiefel. Please go ahead. Hi, this is Jack Padovano calling in on behalf of Annabel Samimy.
The next question comes from Jack Padovano of Stifel. Please go ahead.
Hi, This is jackpot ivano, calling in for Annabel <unk>. Thanks for taking our question.
Jack Padovano: Thanks for taking our question. So again, I just wanted to touch briefly on the NASH resolution data from the Terzepatide Synergy NASH trial. Just curious if those results change where you view THR beta receptor agonists kind of fitting into the treatment paradigm given the more similar upstream liver fat impacts that both mechanisms have. Yeah, thanks, Jack. It doesn't really change our view of the role of a targeted agent. We do think, you know, there are going to be a lot of different therapies used in this population. The population is very heterogeneous to begin with, and different patients will be better suited to different treatments. So we do see the targeted agents as remaining relevant for sure. That said, I think it would be naive to think that GLP-1, type.
So again just wanted to touch briefly on the Nash resolution data from Deputised synergy Nash trial, just curious if those results change.
Or do you view THR beta receptor agonist.
Heading into the treatment paradigm.
Given the more.
Upstream liver fat impacts that both mechanism.
Yeah. Thanks, Jack It doesn't really change our view of the the role of a targeted agent. We do think there's going to be a lot of different therapies used in this population. The population is very heterogeneous.
To begin with in different patients will be better suited for different therapies. So we do see the targeted agents is remaining relevant for sure.
That said I think.
It would be naive to think that <unk> won.
Brian Lien: Therapeutics won't be important in the treatment paradigm, potentially as a sort of a backbone for the overweight or the diabetic patient, but we still see there's a nice opportunity for a targeted agent. Great. Thanks for the call, Eric. Thanks, Jack. The next question comes from Justin Zelen of BTIG. Please go ahead.
Type.
Therapeutics won't be important.
In the treatment paradigm potentially as a sort of a backbone in the in the overweight or the diabetic patient.
But we still see there is a.
Nice opportunity for targeted agent.
Great. Thanks for the color.
Thanks Jay.
The next question comes from Justin Zelman of B T. I G. Please go ahead.
Justin Zelen: Thanks for taking the question and congrats on the progress. Brian, I wanted to ask you about the earlier guidance for sub-q formulation of 2735 here being released. I had guidance into the level of interest or demand on behalf of patients for a sub-q rather than oral or just how we should be thinking about that. No, it was just a, thanks Justin, it was just a... The trial was enrolled more quickly than expected, and there were no hiccups during the course of the study, so we think we should have the data this quarter. Going back to demand, the demand was reflected in the speed and size of the trial. It was really pretty easy to enroll.
Thanks for taking the question and congrats on the progress Brian I wanted to ask.
To the earlier guidance for Q formulation of two 735 here.
Being released.
Guidance into level of interest or demand on behalf of patients for sub Q, rather than oral or just how should we should be thinking about that.
No. It was just it was just.
The trial was enrolled more quickly than expected and.
We're no hiccups during the course of the study and so we think we should have the data this quarter.
Going to the demand I mean that just it was just the demand was reflected in the speed and size of the trial.
Pretty pretty easy to enroll.
Brian Lien: That makes sense to me. And is it possible we could get the oral and the substitute data at the same time, on the same date? No, probably not.
That makes sense to me and is it possible, we could get the the oral and the substitute data at the same time on the same day.
No probably not and we haven't disclosed the sequence just other than to say both both will be this quarter.
Brian Lien: And we haven't disclosed the order, just other than to say, you know, both will be this quarter. Great. Thanks for taking my question. Thanks, Josh. This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks. Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a great afternoon. The conference is now concluded. Thank you for attending today's presentation, and you may now disconnect.
Great. Thanks for taking my questions.
Thanks, Justin.
This concludes our question and answer session I would like to turn the conference back over to Stephanie Diaz for any closing remarks.
Thank you again for your participation and continued support of Viking Therapeutics, we look forward to updating you again in the coming months have a great afternoon.
The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.
Okay.
Okay.
Yeah.
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