Q4 2019 Earnings Call
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Good day and welcome to the Viking Therapeutics fourth quarter 2019 and year-end conference call all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
After today's presentation, there will be an opportunity to ask questions to ask the question. You may press * then 1 on your touchtone and to withdraw your question, please press * then two, please note this event is being recorded. I would like to turn the conference over the phone, please. Go ahead.
Hello, and thank you all.
For participating in today's call joining me. Today is Brian Lantz Vikings president CEO senior vice president Finance before we begin I'd like to caution that I made during this conference call today February 26th, 2020 will contain forward-looking statements within the meaning of the Securities Act of 1933 concerning the current beliefs of the company which involve a number of assumptions risks and uncertainties actual results could differ from these statements and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian land for his initial comments Brian Stephanie and thanks to everyone listening on the webcast or bath today will provide an overview of our fourth quarter and year-end 2019 Financial results as well as an update on recent progress and developments related to our pipeline programs and operations.
2019 was the year of tremendous progress biking building on the momentum that followed the successful outcomes of our completed clinical studies with respect to our lead program DK 2809 South Navajo fabric receptor beta-agonist. We completed the important work required Ford a face-to-face study in patients with biopsy confirmed Nash and we are pleased to announce in November of the initiation of this important study.
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Able to 1 for our second thyroid receptor beta our efforts during 2019 focused on continuing the ind-enabling work required documents clinical studies of this molecule, and we expect to file an eye on this program first half of this year.
I would provide additional detail on our development activities in a few minutes, but first we'd like to review our fourth quarter and year-end Financial results for that. I'll turn the call over to Greg's and Vikings senior Vice President of Finance Craig. Thanks Brian in conjunction with my comment. I'd like to recommend that participants refer to biking form 10-K filing with the Securities and Exchange Commission, which were filed after the market closed for additional details.
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First go over our financial results for the fourth quarter ended December 31st, 2019.
A research and development expenses for the 3 months ended December 31st 2019 for 6.5 compared to 5.1 million to the same. In 2018. The increase was primarily due to increased expenditures related to clinical studies with the initiation of these Voyage study during the quarter and Manufacturing for our drug candidate partially offset by decreased expenses related for a preclinical studies Home Services provided by third party consultant.
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Administrative expenses the 3 months ended December 31st 2019 were 2.4 million heard of 1.9 billion for the same period in 2018.
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Increase was primarily due to increased expenses related to stock-based compensation of professional fees.
For the three months ended December 31st, 2019 biking reported net loss of seven point five million or ten cents per share compared to a net loss of 5.2 million or 7 cents per share in the corresponding with the 2018.
Increase in net loss and that loss per share for the three months ended December 31st, 2018 was primarily due to increased research and development and general administrative expenses as you previously as well a decreased interest income due to the decline in interest rates throughout 2019 as compared to prevailing interest rates during the fourth quarter of 2018.
Not provide our financial results for the 12 months ended December 31st, 2019.
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A research and development expenses for the 12 months ended December 31st, 2019 were twenty three point six million compared to nineteen million for the same. In 2018. The increase was primarily due to increased expenses related to manufacturing for a drug candidates clinical studies Services provided by third-party consultants and salaries and benefits partially offset by decreased expenses related to preclinical studies.
Good day and welcome to the Viking Therapeutics fourth quarter 2019 and year-end conference call. All participants will be in life. Only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
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Expenses for the 12 months ended December 31st, 2019. We're 9.1 million to 7.1 million for the same period in 2018.
After today's presentation, there will be an opportunity to ask questions to ask a question. You may press * then 1 on your touchtone and to withdraw your question, please press * then two, please note this event is being recorded. I would now like to turn the conference over to Stephanie Diaz of investor relations office, please go ahead.
Increase was primarily due to increased expenses related to stock-based compensation Services provided by third-party Consultants corporate Insurance legal and patent expenses and professional fees.
For the 12 months ended December 31st, 2019 biking reported a net loss of 25.8 million or $36.36 per share are doing that loss of 22.1 million or 30,000 for sure the corresponding period in 2018 the increase in net loss for the 12 months ended December 31st, 2019 was primarily due to increased research-and-development and general administrative expenses that known as noted previously partially offset by increased interest income as well as the elimination of expenses related to the change in fair value of the debt conversion feature liability due to the repayment of the ligand moja a 2018.
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If you all for participating in today's call joining me. Today is Brian Lantz Vikings president and CEO and Greg's and Senior Vice President of Finance before we begin I'd like to caution that comments made during this conference call today, February 26th, 2020 will contain forward-looking statements within the meaning of the Securities Act of 1933 concerning the current beliefs of the country which involve a number of assumptions risks and uncertainties actual results could differ from these statements and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now to the call over to Brian Leon for his initial comments Brian. Thanks Stephanie and thanks to everyone listening on the web page by phone today will provide an overview of our fourth quarter and year-end 2019 Financial results as well as an update on recent progress and developments related to our pipeline programs operations.
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4share for the 12 months ended December 31st 2019 was primarily driven by the additional weighted average shares outstanding December 31st, 2019 versus those outstanding at December 31st, 2018 given the public Equity financing that occurred during 2018.
Bring you the balance sheet December 31st, 2019 biking help Cash Cash equivalents and short-term Investments, totaling 275.6 million and had 72413602 shares of common stock outstanding. This concludes my financial review and I'll now turn the call back over to Brian.
2019 was the year of tremendous progress at biking building on the momentum that followed the successful outcomes of our completed clinical studies with respect to our lead program. Vk2809 wage both. I work receptor beta-agonist. We completed the important work required to support a phase to be study in patients with biopsy confirmed Nash and we are pleased to announce in November of the initiation of this important study month.
Thanks, Greg. I'll now provide an update on recent progress in activity with our lead program. Vk2809 as a reminder Toyo nine is an orally available small-molecule Agonist of the thyroid hormone receptor that possesses selectivity for liver tissue as well as the beta receptor subtype suggesting promising therapeutic potential and a range of metabolic disorders including match in September 2018. We announced positive results from a 12 weekdays to trial of the case with Hyundai in patients with hypercholesterolemia, non-alcoholic fatty liver as we've previously discussed this trial successfully cheat primary secondary in demonstrating potent reductions in liver fat content as well as improvements plasma.
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The vehicle to 1 for our second thyroid receptor beta-agonist our efforts during 2019 focused on continuing the ind-enabling work required to commence clinical studies of this molecule, and we expect to file and Monday for this program in the first half of this year.
I will provide additional detail on our development activities a few minutes, but first we'd like to review our fourth quarter and year-end Financial results for that. I'll turn the call over to Greg's Auntie Vikings Vice senior Vice President of Finance Greg. Thanks Brian in conjunction with my comments. I'd like to recommend that participants refer to Vikings form 10-K filing with the Securities and Exchange Commission, which were filed after the market closed for additional details.
as a brief reminder
Patients receiving vo9 experience median relative reductions in liver fat ranging from 54% to approximately 60% compared with approximately 9% or Placebo the proportion of patients experiencing at least a 30% relative reduction in liver fat range from 77% to 100% with the overall average of 88% compared with 17% off locations in addition 70% of patients receiving vk2809 experienced at least a 50% relative reduction in liver fat content compared to Baseline.
First go over our financial results for the fourth quarter ended December 31st, 2019.
A research and development expenses for the three months ended December 31st, 2019 6.5 million compared to 5.1 million for the same period of 2018. The increase was primarily due to increased expenditures related to clinical studies with the initiation of the phase to be Voyage study during the quarter and Manufacturing for our drug candidates partially offset by decreased expenses related to our preclinical studies wage Services provided by third-party consultant.
DK Twitter nine also produced significant reductions in plasma lipids including including LDL cholesterol triglyceride and after genic proteins such as protein be like, oh this lipid-lowering profile is a novel feature of thyroid receptor beta activation and is a particular interest in the setting of Nash as it may suggest long-term cardiovascular benefit.
General and administrative expenses for the three months ended December 31st, 2019. We're 2.4 million compared to 1.9 million for the same period in 2018.
Increase was primarily due to increased expenses related to stock-based compensation of professional fees.
In addition to the impressive. Advocacy observe vk2809 has also demonstrated in encouraging safety and tolerability profile in the phase two study. No serious Adverse Events were reported among patients receiving vk2809 for Placebo and the overall numbers of Adverse Events were relatively evenly distributed across treatment arms.
For the three months ended December 31st, 2019 biking reported that lost 7.5% for Scherer compared to a net loss of 5.3 million or 7 cents per share in the corresponding wage 2018.
Increase in net loss and that loss per share for the three months ended December 31st, 2019 was primarily due to increased research-and-development and general administrative expenses as a previously as well a decreased interest income due to the decline in interest rates for up 2019 as compared the prevailing interest rates during the fourth quarter of 2018.
We Believe It or Not in Stoughton liver specific effect combined with the safety of our ability and potential cardiovascular benefits set it apart from competitive programs targeting Nash and we are very pleased to advance this compound to a phase to be study in patients with biopsy confirmed Nash
I'm not provide our financial results for the 12 months ended December 31st, 2019.
In preparation for this study in 2019. We completed several additional clinical and preclinical evaluation to enable us to file a new is the fda's division of gas and inborn errors product as a reminder a new ID is required because the prior int was directed toward hyperlipidemia and was active in the division of metabolic and endocrine product. However GI division is where most Nash IND applications are reviewed.
A research and development expenses for the 12 months ended December 31st, 2019 were twenty three point six million compared to nineteen million for the same. In 2018. The increase was primarily due to increased expenses related to manufacturing for a drug candidate clinical studies Services provided by third-party consultants and salaries and benefits partially offset by decreased expenses related to preclinical studies.
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The Strait of expenses for the 12 months ended December 31st 2019 were 9.1 million for the 7.1 million for the same period in 2018.
For the national n d during 2019. We completed several new studies in addition to the 12 weekdays to study. I described a moment ago these included a phase one study to evaluate the safety tolerable and pharmacokinetics of eight or nine when co-administered with the core of Staten the results of this study confirmed previously reported data demonstrating no meaningful interaction between 8 or 9:00 and its authors.
Increase was primarily due to increased expenses related to stock-based compensation Services provided by third-party Consultants corporate Insurance legal and patent expenses and professional fees.
For the 12 months ended December 31st, 2019 biking reported a net loss of 25.8 million or 36 36 cents per share compared to a net loss of 22.1 million or 38,000 for sharing the corresponding period in 2018 the increase in net loss for the 12 months ended December 31st, 2019 was primarily due to increased research-and-development and general administrative expenses had known previously partially offset by increased as well as the expenses related to the change in Fair Value that conversion feature liability due to the repayment of the like end of June 2018.
We also conducted the phase one study to evaluate the safety tolerability and pharmacokinetics of vk2809 those in every other day regimen these data confirmed previously reported results demin that VK to eight or nine possesses a predictable and consistent speak a profile.
We also conducted a phase one study to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of under various dosing regimens. These data demonstrate that alternative dosing regimens may also produce Improvement in measures of plasma lipid.
It's a net loss per share for the 12 months ended December 31st. 2019 was primarily driven by the additional weighted average shares outstanding December 31st, 2019 versus those outstanding it off 30% 2018 given the public Equity financing to the current during 2018.
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We completed toxicity studies of twenty-six and fifty-two weeks in duration to support chronic dosing in humans.
The results of this and prior work formed the basis of the new ID that was filed with the CI division following the IND filing in November. We announced the initiation of a phase to be study in in of eight or nine in patients with Nash. We've named this study of the voyage study and we're excited to have it under way. The voyage study is a randomized double-blind placebo-controlled multicenter turbo designed to assess the efficacy safety and tolerability of Decay 2 8 or 9 in patients with biopsy confirmed and fibrosis the study will Target enrollment of approximately 340 patients about five treatment arms, including one milligram daily, 2.5 milligrams daily five milligrams every other day 10 milligrams every other day and placebo.
Bring you the balance sheet at December 31st, 2019 biking cash equivalent and short-term Investments, totaling 275.6 million and had 72413602 shares of common stock outstanding. This concludes my financial review and I'll now turn the call back over to Brian.
Thanks, Greg. I'll now provide an update on recent progress in activity with our lead program DK to 8:09. As a reminder VK. Toyo. Nine is an orally available small-molecule Agonist of the thyroid hormone receptor that possessed selectivity for liver tissue as well as the beta receptor subtype suggesting promising therapeutic potential in a range of metabolic disorders, including Nash in September 2018. We announced positive results from a 12-week phase two trial of the case. We don't live in patients with hypercholesterolemia, non-alcoholic fatty liver disease as we've previously discussed this trial successfully Jeep primary and secondary endpoints demonstrating introductions and liver fat content as well as improvements in plasma with advisors.
The target population includes patience with step 2 and 1/2 3 fiber as well as up 25% with F1 fibrosis.
1 patients must also possess additional risk factors to be eligible for enrollment.
The primary endpoint of the study will evaluate the relative change and liver fat content as asked by a magnetic resonance. Imaging proton density fat fraction from Baseline to week 12 in subjects treated with v-club online as compared to Placebo secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after two weeks of dosing.
as a brief reminder
Patients receiving experience median relative reductions and liver fat ranging from 54% to approximately 60% compared with approximately 9% or Placebo the proportion of patients experiencing at least a 30% relative reduction in liver fat range from 77% to 100% with the overall average of 88% compared with 17% for precipitation.
We are currently dosing patient's medical sites in the US and expect to open additional site outside the US later this year.
In addition to commencing the voyage study in the fourth quarter. We submitted an abstract driving additional data from the prior 12 weekdays to study of decayed to 8:09 for presentation at the annual meeting a European Association for the study of liver or easel. We were recently informed that this abstract has been selected for an oil presentation on April 17th.
In addition 70% of patients receiving vk2809 experienced at least a 50% relative reduction in liver fat content compared to Baseline.
DK Twitter nine also produced significant reductions in plasma lipids including including LDL cholesterol triglyceride and after genic proteins such as protein be and liposuction day. This lipid-lowering profile is a novel feature of thyroid receptor beta activation and is a particular interest in the setting of that as it may suggest long-term cardiovascular benefit.
We look forward to sharing these additional data at that time.
Given the positive results from the previous phase two trial and the supplemental data generated in multiple studies during 2019. We continue to believe that Toyota and demonstrates building and safety package with the potential to provide benefits to the millions of patients worldwide suffering from match. We look forward to sharing additional updates on it online and the voyage study as the trial progressed.
In addition to the impressive actually observe vk2809 also demonstrated an emerging safety and tolerability profile in the phase two study. No serious Adverse Events were reported on page eight or nine four plus and the overall numbers of Adverse Events were relatively evenly distributed across the street bar.
Provide an update on our program dikhao to 1/4 is being evaluated as a potential treatment for x-linked adrenoleukodystrophy or XLT XLT is a dead stating disease for which there is no approved treatment. The disease is caused by a defect and a proximal transporter called abcd1. This defect can result in an accumulation of very long plasma and tissue and it is these elevated very long chain fatty acid levels that are believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of disease.
We believe it on liver specific effect combined with the safety tolerability potential cardiovascular benefits set it apart from competitive programs targeting Nash and we are very pleased to advance this compound to a phase to be study in patients with biopsy confirmed Nash.
In preparation for this study in 2019. We completed several additional clinical and preclinical evaluations of DK to 8:09 to enable us to file a new IND with the fda's division of gas ology and inborn errors product as a reminder a new ID is required because the prior IND was directed for hyperlipidemia and was active in the division of metabolic and endocrine product. However, the GI division is where most Nash IND applications are reviewed.
Thyroid beta receptor is an important potential targets for therapeutic intervention an XLT because it's believed to play a role very long chain fatty acids tablets.
Like Victory or 92144 Lee available small molecule by receptor that possesses selectivity for the beta receptor subtype today results from in vitro and off-premise traded that administration of results in a significant increase in the expression of a compensatory transporter, which is believed to result in a reduction of very long chain fatty acids in both Flash and tissue.
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For the national n d during 2019. We completed several new studies in addition to the twelve weeks days to study. I described a moment ago these included a phase one study to evaluate the safety tolerability and pharmacokinetics of eight or nine when co-administered with atorvastatin the results of this study confirmed previously reported data demonstrating no meaningful interaction between a 2009 and its orbit.
Given these promising results. We believe they provide benefits and we are eager to move this program into the clinic.
We are currently conducting ind-enabling work for video to 1 for and we expect to file the IND in the first half of this year followed by initiation of a proof-of-concept study employment.
We also conducted a phase one study to evaluate the safety tolerability and pharmacokinetics of eke 82809 those and every other day read these data confirmed previously reported results. Demin that decayed to eight or nine. So that's just too predictable and assistant EK profile.
With our to lead programs advancing and clinical development. We continue to carefully manage your balance sheet as Greg reported earlier. We ended 2019 with approximately $275 million in cash and equivalents.
We also conducted a phase one study to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of under various dosing red.
we believe these resources provide ample Runway to reach multiple clinical inflection points with both DK to 8:09 and one for
In closing I'd like to reiterate that the important work completed in 2019 was critical to pave the way for realizing the potential of both DK to 8:09 and 4 or Thursday the compelling data generated in both 2018 and 2019 validate our believe that it is one of the most promising candidates in development today for the treatment of Nash and we are excited to see Advanced it through the clinic. We look forward to continued enrollment in our face to be Voyage studies with respect to dikhao to 1/4. We continue working toward completion of the IND enabling studies that seem to initiate a proof-of-concept study in humans. It is our goal to file this IND during the first half of the year.
These data demonstrated that alternative dosing regimen may also produce Improvement in measures of plasma lipid.
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We completed toxicity studies of twenty-six and fifty-two weeks in duration to support chronic dosing in humans.
We look forward to sharing these additional data at that time.
Given the positive results from the previous phase two trial and the supplemental data generated in multiple studies during 2019. We continue to believe that d k through eight or nine demonstrate only fifteen safety package with the potential to provide benefits to the millions of patients worldwide suffering from Nash. We look forward to sharing additional updates on VK Toyota and the voyage study. That's the trial progressed.
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Our balance sheet remains strong providing the resources to execute through multiple value-creating events.
I'll now provide an update on our program dikhao to 1/4 is being evaluated as a potential treatment for x-linked adrenal leukodystrophy or XLT package is a devastating disease for which there is no approved treatment. The disease is caused by a defect in a peroxisomal transporter called abcd1. This defect can result in an accumulation a very long chain fatty acids in plasma and tissue and it is these elevated very long chain fatty acid levels that are believed to contribute to the severe cerebral and motor neurons toxicities that are characteristic of these.
This concludes our prepared comments for today. Thanks again for joining us, and I'd now like to open the call for questions operator.
Thank you. We will now begin the question-and-answer session to ask a question. You may press * then 1 on your touchtone phone. If you are using a speaker phone, please pick up your handset before pressing the keys to withdraw your question, please press * then two and at this time we will pause for a moment to assemble our roster off. Our first question today will come from Jim Lee of Sentra, please go ahead.
Thyroid beta receptor is an important potential targets, but therapeutic intervention in XLT because it's believed to play a role in very long chain fatty acids tablets.
Hi, thanks for taking my questions and congrats and getting the podium presentation four to eight or nine easel in addition to the original data from the base to novel study. I also be sharing additional preclinical tox data as well. And can you tell tell us where you are in submitting the the full tox data to cover the entire twelve months. Is that eminent org has has it already been submitted and I have one more follow-up. Thank you. Hey Junior. Thanks for the questions know as part of the presentation at eazel. We won't be disclosing any of the the toxicity studies that were completed in animals the the mission of the full 12 months data set is imminent birth. And you know, it's very near-term. It's a public reports are completed. They're just going to going final proofing.
Like Victor 80914 poorly available small-molecule fire receptor that possess the selectivity for the beta receptor subtype today's results from in vitro and in Vivo South demonstrated that the administration of results in a significant increase in the expression of a compensatory transporter, which is believed to result in a reduction of very long chain fatty acids in both Flash and tissue.
Given these promising results We Believe dikhao to 1/4 May provide benefits to patients with and we are eager to move this program into the clinic.
We are currently conducting ind-enabling work for video to 1 for and we expect to file the IND in the first half of this year followed by initiation of a proof-of-concept study in humans.
With our to lead programs advancing and clinical development. We continue to carefully manage our balance sheet as Greg reported earlier. We ended 2019 with approximately 275 million months.
great, and can you tell us a little bit about the design of the
We believe these resources provide ample Runway to reach multiple clinical inflection points with both DK to 8:09 and dikhao.
The XLT proof-of-concept study what that would look like and what you would hope to learn from that initial study. Thank you. Yeah, no great question. So the it's sort of a two-month tiered clinical study. The first portion will Target a healthy Volunteers in guess it's called the stack design where you age you begin single ascending dose study in healthy volunteers and during that you begin dosing multiple things. So strong and healthy volunteers and during that that you begin enrolling patients with LD. We would Target a a 28-day treatment window and took a look at very long chain fatty acid changes after Twenty Eight Days and with those data then if they're encouraging we would then speak with the FDA about what the next steps off.
In closing I'd like to reiterate that the important work completed in 2019 was critical to save the way of realizing the potential of bhosdi ke to 8:09 and or V6 selling data generated 2018 and 2019 validate our believe that it is one of the most promising candidates in development today for the treatment of math and we are excited to be Advanced get through the we look forward to continue the Roman in our face to be voice study with respect to one for we continue working toward completion of the ID enabling studies that would allow us to initiate a proof-of-concept study in humans. It is our goal to file this IND during the first half of the year.
Finally our balance sheet remains strong providing the resources to execute through multiple value-creating events.
You look like but that would be the proof-of-concept.
This concludes our prepared comments for today. Thanks again for joining us, and I'd now like to open the call for questions operator.
And when once we hope to get the top line, if I don't I mean from the initial study. Yeah, I would say the same most likely window for that. Probably going to be first half of Twenty-One. I mean, it's not impossible that it would be available later this year, but I would say first happened twenty one is Thursday a safe bet great. Thank you very much. Okay. Thanks.
Thank you. We will now begin the question-and-answer session to ask a question. You may press * then 1 on your touchtone phone. If you are using a speaker phone, please pick up your handset before pressing the keys to withdraw your question, please press * then two and at this time we will pause for a moment to assemble our roster off. Our first question today will come from ginley of SunTrust, please go ahead.
Our next question will come from Steve Feed House of Raymond James, please go ahead.
Hi, good afternoon. My question is on one theme that's come up in the field in a couple recent days to studies and also some of the recent meetings and that is I was hoping you could clarify it's generally what the biopsy reading protocol is for the face you be study. For example, how are biopsies blinded or scrambled to the reading pathologist? How many Pathologists are there? And are you going to be rereading Baseline biopsies at the end of the study or does the screening biopsy kind of serve as the time Zero comparator? Thanks God. Yeah. Thanks Steve. It's it's a great and and sounds like question. I don't have the answer for all of the parts of it. We are using one pathologist with that person will be reviewing the the Baseline and treatment biopsy. We will not be dead.
Hi, thanks for taking my questions and congrats on getting the podium presentation for tomorrow night at evil in addition to the original data from the base.
To study. Well, you also be sharing additional preclinical tox data as well. And can you tell tell us where you are in submitting the the full talks data to cover the entire twelve months. Is that imminent or has has it already been submitted and I have one more follow-up. Thank you. Hey Junior. Thanks for the questions know as part of the presentation easel. We won't be disclosing any of the the toxicity studies that were completed in animals the admission of the full 12-month is imminent. And you know, it's very near-term. I'd say all those reports completed. There's still undergoing final QC office opening.
Great, and can you tell us a little bit about the design of the the XLT proof-of-concept study what that would look like and what you would hope to learn from that initial study. Thank God. Yeah, no great question. So the it's sort of a two-tiered clinical study. The first portion will Target a healthy Volunteers in guess it's called the Stacked design where you you begin single ascending dose study in healthy volunteers and during that you begin dosing multiple saying don't study also in healthy volunteers and during that then you begin enrolling patients with exhale deep thought we would Target a a 28-day treatment window and look at very long chain fatty acid changes after Twenty Eight Days and with those data then if they're dead.
Reshuffling and and reassessing the bay.
I'm at a later date. And I think that's about all I know on the logistics of the the biopsy months later, but we're not going to send it out multiple people or or reshuffle and and do that sort of thing. Okay, that's those details are already helpful given a variance. There is between study still. Thank you for that. The other thing I just wanted to ask in terms of the enrollment the phase to be study long. Are you willing to stay kind of what inning you're in there or roughly how long you think it'll take you to fully enrolled the study? Yeah. I think it's it's early to say the early Innings be a lot more money, but we're still in the in the in the ramp up process opening sites, and we're I think moving along the according to schedule.
encouraging we would then speak with the FDA about
What the next steps might look like but that would be the proof-of-concept and when when can we hope to get the top line? If I don't I mean from the initial study. Yeah, I would say the the most likely window for that is probably going to be first half of Twenty-One. I mean, it's not impossible Thursday would be available later this year, but I would say first half of 21 is uh a safe. Great. Thank you very much. Okay. Thanks.
There we will be adding well to Fifteen sites outside the US and those are expecting some online or in the second quarter and it's a little early to give guidance on completion of romance. I certainly expected to be in 2020 but tightening from there. I don't know it's hard to do right now.
Okay, appreciate it. Thanks for taking the questions. Look forward to seeing you additional data a diesel.
Thanks to you.
Our next question will come from Derek arcilla of Cecil, please go ahead. Hi Bill on for Derek congrats on the progress in 2019. So first from us, can you just speak to sort of what other biomarkers you you're evaluating in the study? And then that's what we'll what which of those biomarkers you'll read out at the same time. Um as the MRI PDF f
Our next question will come from Steve details of Raymond James, please go ahead.
Hi, good afternoon. My question is on one theme that come up in the field in a couple of recent studies and also some of the recent meetings and that is I was hoping you could clarify exactly what the biopsy reading protocol is for the face to be study. For example, how are biopsies blinded or scrambled to the reading Pathologists? How many Pathologists wage are there? And are you going to be rereading Baseline biopsies at the end of the study or does the screening biopsy kind of serve as the time Zero comparator? Thanks God. Yeah. Thanks Steve. It's it's a great and and complex question. I don't have the answer for all of the parts of it. We are using one pathologist with that person will be reviewing the the Baseline and end of treatment biopsy. We will not be.
Yeah, so we're looking at the the elf panel. We're looking at the proceed 3. We're looking at temp one and and several others. I don't have that full lives in front of me and I'm not sure yet. If we'll read out all of that with the 12-week data. Sometimes those take a little longer to is a different Labs off those evaluations that might take a little bit longer to to receive but will play it by ear there but is a whole panel of other biomarkers. We looking at
Great.
And then can you brief just really briefly describe the differences between $2 and $4.28.
Reshuffling and and reassessing the base.
Mine at a later date and I think that's about all I know on the logistics of the the biopsy read procedure, but we're not going to send it out to multiple people or or reshuffle and conduce that sort of thing. Okay. Those details are already helping lead to given a variance there is between study still thank you for that. The other thing I just wanted to ask in terms of the enrollment the phase to be study wage. Are you willing to say kind of what inning you're in there or for roughly how long you think it'll take you to a fully enrolled to study? Yeah. I think it's it's early to say see the early Innings the wage, but we're still in the in the ramp up process opening sites, and we're I think moving along the according to schedule.
Yeah, yeah different structures. So oh two one four has slightly different substitution pattern on one of the aromatic Rings wage. And as a result, it has the slightly better beta selectivity and the p d profile is just a little bit different. We always look at those guys in parallel in in all of our animal studies and you know on some metrics, it's Superior on other metrics to 8:09 is computers. So I think they're both tremendously effective in the in Vivo models for Nash. But when you look at the profile be cable to one for seems to be effective in l a l d and 289 is is not very effective there. So that was a key difference than the the actual and Depot data. Does that have to do with the liver sensitivity of 2809 South?
There we will be adding twelve to Fifteen sites outside the US and those are expecting some online in the second quarter off and it's a little early to give guidance on completion of romance. I certainly expected to be in 2020 but tightening from there. I don't I it's hard to do right now.
Maybe
I don't know. It was a surprise to us to see that the Delta there since they're similar in virtually every other a say, but it could it could have that. I mean that could play a role their wage great. Thanks a lot for the question.
Okay, appreciate it. Thanks for taking the questions. Look forward to seeing you additional data a diesel.
Our next question will come from Scott Henry Roth Capital, please go ahead. Thank you. Good afternoon. Just a couple of questions first off on the modeling for 2020. How should we think about are indeed been throughout the year should we ramp it steadily and then as far as magnitude perhaps relatively 29th, you know, are we thinking you know double 2019 spending just trying to get a sense on R&D for the year. Yeah. It's a good question. Thank Scott. It's going to be certainly life and in in 2019 and I would say overall the Senate will be about 50% higher skewed a little bit. Well, it's going to be a gradual, right. So for you is going to be higher than one q and one Q is going to be higher than four Q nineteen, but when you think about overall R&D and overall topic about the Dead
Thanks to you.
Our next question will come from Derek artilla, please go ahead. Hi Bill on for Derek congrats on the progress in 2019. So first from us, can you just speak to sort of what other biomarkers you you're evaluating in the study? And then we'll which of those biomarkers you'll read out at the same time. Um as the MRI dff.
Yeah, so we're looking at the the elf panel. We're looking at the proceed 3. We're looking at temp one and and several others. I don't have that full lives in front of me and I'm not sure yet if will read out all of that with the with the 12-week data, sometimes those take a little longer to is a different Labs all those to evaluations that might take a little bit longer to to receive but will play it by ear there but is a whole panel of of other biomarkers. We looking at
that but right now we think it's gonna be able to
2% higher Greg. Do you have any other day? Yeah, no that that's right on target. I think yep.
Okay, great. Thank you for that color. It just one question on the trial. I realize it's not new. But but we haven't had a chance to talk about it. When you look at the five doses. I was a little surprised not to see a five milligram daily since it was you know, relatively robust dose in the earlier trial any thoughts on on deciding which ones to go with and white one with 5,000 is every other day versus daily. Yeah, we we definitely it's a great question. So we definitely wanted to have some overlap with the the face to a study for comparative purposes. We thought that going with the higher sort of a pulsatile Dost might be advantageous. I mean, I think you could argue same five makes steady would be advantageous based on the data. But anyway, we chose to go with 10 Megs just to have that the overlap Dost and then step down from there. We went to five minutes every other day because we know that when we look at the last three doses in the face wage.
Great.
And then can you brief just really briefly describe the differences between 2 and 4 and 28. 9.
Yeah, yeah different structures. So oh two one four has slightly different substitution pattern on one of the aromatic rings off and as a result. It has the slightly better beta selectivity and the p d profile is just a little bit different. We always look at those guys in parallel in in all of our animal studies and you know on some metrics, it's Superior on other metrics to 8:09 is superior. So I think they're both tremendously effective in the in Vivo models for Nash. But when you look at the profile dikhao to 1/4 seems to be effective in l l d and vk2809 is is not very effective there. So that was a key different than the the actual and Depot data. Does that have to do with the liver sensitivity of 29 month?
all pretty much stacked on top of each other as
As far as ethics we so we were we felt right on the far right-hand side of the boat response or so. We think that coming down as we are we should still see Thursday and we have that overlap with the very effective and like every other day from the base to a study. Okay, great. Thank you for that additional color and thank you for taking the question. Thanks, Our next question will come from Andy of William Blair, please go ahead.
Maybe
I don't know. It was a surprise to us to see that the Delta there since they're similar in virtually every other a say, but it could it could have sat. I mean that could play a role. They're dead. Great. Thanks a lot. Thanks for the question.
Great. Thanks for taking my question. So I think in your new slide back, you mentioned about potential weight loss. I know that from clinical trials based. So obviously getting about $28 here the phase one and phase two, unfortunately dosing mathematician was about twelve weeks probably did see that but just maybe from non-human primates. You see something like that, uh from the compound just give it the the fact that it's it's an Agonist to the thyroid pathway.
Our next question will come from Scott Henry of Roth Capital, please go ahead. Thank you and good afternoon. Just a couple of questions first off on the modeling for 2020. How should we think about R&D spend throughout the year should we ramp it steadily and then as far as magnitude perhaps relatively 29th, are we thinking, you know double 2019 spending just trying to get a sense on R&D for the year? Yeah, it's good question. Thanks Scott. It's going to be certainly higher then in in 2019 and I would say overall the spend will be about 50% higher skewed a little bit. Well, it's going to be a gradual range. So for you is going to be higher than one q and one Q is going to be higher than four Q nineteen, but when you think about overall R&D and overall Optics about fifty years
Yeah.
I don't think we talked about that in the slide deck. We don't see any meaningful way. It changes. When you look at Vital sign across the four cohorts in the home study. The placebo cohort was a little bit skinnier and they gained about a pound and then the treated cohorts were a little heavier and they lost about a about a pound so but there was no didn't look like there was any dose-response there and we just we don't think there's any Techs on on weight from obvious in that study the thing too. I mean everybody wants to the therapies to lose weight because that's also plays a role in in the signal in Nash. But with this ma'am, it's a little bit more problematic because the weight loss might be taken as a proxy for thyroid Alpha activation. And so you really don't want to see it wage.
but right now we think it's going
A 50% higher Greg. Do you have any other? Yeah, no that that's right on target. I think yeah.
Okay, great. Thank you for that color. It just one question on the trial. I realize it's not new. But but we haven't had a chance to talk about it. When you look at the five doses. I was surprised not to see a five milligram daily since it was you know, relatively robust dose in the earlier trial any thoughts on on deciding which ones to go with and white one with 5,000. But every other day versus daily. Yeah, we we definitely it's a great question. So we definitely wanted to have some overlap with the the base the way study for comparative purposes. We thought that going with the higher sort of a pulsatile Dost might be advantageous. I mean if you could argue same five makes steady would be advantageous based on the data. But anyway, we chose to go back 10 minutes just to have that the the overlap those and then step down from there. We went to five minutes every other day because we know that when we looked the last three doses in the phased wage
thyroid the beta-agonist in the early studies once you can stab
Safety parameters and maybe in a longer study. Anyway going back to the question that we we didn't see any in the twelve-week study.
Got it. Okay. Thanks for that clarification. So in terms of the easel presentation obviously not compromising your your ability to present just maybe high level of what you should what should we expect and what did you know be what should we be looking for for the new data?
All pretty much stacked on top of each other as far as ethics be so we were we felt right on the far right-hand side of the Bill's response to her. So we think that coming down.
Yeah, it's it's really interesting. We had people come back at week 16 in the study. So the endpoint was at week 12 for everybody and everybody came back for for labs and M16. So we'll present those data as well as some deeper dives into some of the different subsets patient characteristics in the study.
As we are we should still see efficacy and we have that overlap with the very effective and make every other day from the base to agency. Okay, great. Thank you for that additional color and thank you for taking the question. Thanks, Scott. Our next question will come from and please go ahead.
Okay, that's that's helpful. And so in terms of a MN 40214 off, you know, I think one of the challenges for a lot of these rare diseases is diagnosis and I think one of the so that so she is was kind of an included in the screening for newborns in 2015. But obviously there's a lot of adults who potentially could be carriers, but do not know about that. So just wondering from a divorced woman or recruitment perspective. How do you identify these patients and and what are some strategies that you can employ to to food maximize recruitment of this rare disease?
Great. Thanks for taking my question. So I think in your new slide back, you mentioned about potential weight loss. I know that from clinical trials faced obviously need about twenty eight or nine to hear this phase one and phase two. Unfortunately dosing mathematician was about twelve weeks. Probably didn't really see that but just maybe from non-human primates. Did you see something like that? Ugh from the compound just giving the the fact that it's a it's an Agonist for the thyroid pathway.
Yeah, I think so. I don't think we talked about that in the slide deck. We don't see any meaningful way. It changes. When you look at Vital Signs across four cohorts in the twelve-week study. The placebo cohort was a little bit skinnier and they gained about a pound and then the treated cohorts were a little heavier off the lost about a about a pound so but there was no didn't look like there was any dose-response there and we just we don't think there's any effect on on weight from obvious in that study the thing too. I mean everybody wants the therapies to lose weight because that's also plays a role in in the signal in Nash with this mechanism. It's a little bit more problematic because the weight loss might be taken as a proxy for thyroid Alpha activation and so you suck.
Yeah, it's a it's a key challenge fortunately many of these families understand that they do carry the the defect and and there are only a few treatment centers in the US and most of these families are seen at one of four or five treatment centers. We will be engaging those treatment centers in the proof-of-concept portion of the study. And we we feel like, you know, it'll be a relatively small study will Target adult they're easier to shovel and the childhood form and we don't think there will be any significant challenges if it's in the first phase of study anyway given the size availability.
It's something I mean, it's a it's a fair question across the board in setting but most of these families are are staying at the same treatment centers and they're they they know that they. The the team.
Don't want to see it with a thyroid beta.
I guess the earliest. He's once we can establish all the safety parameters then maybe in a longer study. But anyway going back to the question that we we didn't see any in the twelve-week study.
right
Okay, that makes sense. Cool. That's all I have. Thanks for answering all my questions. Thank Sandy.
My next question will come from J. Olsen Oppenheimer, please go ahead. Hey, thank you. Appreciate you taking our questions. This is Matt on for Jay. We were wondering I guess your thoughts on the evolving competitive landscape. For example, NGM just top-line their data from face to the other day. So if you got to take a look at that and then you talk to you might have their escape mechanism compared to the others out there and also maybe is a coil a what potential other combinations with other movies you could imagine being potentially helpful with yours. Yeah. Thanks for the question. I think it's better to direct the the questions about another company's data sets do to that company. I I thought that data looked real exciting and I've always thought that that compound looked very promising. I think the way we think about the competitive advantages for eight or nine are dead.
Got it. Okay. Thanks for that clarification. So in terms of the easel presentation obviously not compromising your your ability to present just maybe high level of what I'm working we expect and what did you know be what do we be looking for for the new data?
Yeah, it's it's really interesting. We had people come back at week 16 in the study. So the end point was that we 1260 and everybody came back for for labs and off at week sixteen and so we'll present those data as well as some deeper dives into some of the difference subsets patient characteristics in the study lounge. Okay, that's that's helpful. And so in terms of 40214, I you know, I think one of the challenges for a lot of these rare diseases is diagnosis and I think one of the so that so she is was kind of included in the screening for new born 2015. But obviously there's a lot of adults who potentially could be carriers, but do not know about that. So just wondering from a trial and birth
Number one, it's oral. It's very effective on.
In in animals on fibrosis and humans on on liver fat and key differentiator for this mechanism is that you see a reduction across the board in plasma if it's not just LDL, but also also after Jenny protein and on top of that excellent tolerability was engaged to it on either. There's no sort of a challenge or anything like that song very well tolerated across the board. So I think we feel good about the competitive profile the more we see evolving in the space.
and for recruitment perspective
Is how do you identify these patients and what are some strategies you can employed it is to maximize recruitment of of the severe disease. Yeah. It's a it's a key challenge, but unfortunately many of these families understand that they do carry the the defect and and there are only a few treatment centers in the US and most of these families are seen at one of four or five treatment centers. We will be engaging those treatment centers wage in the proof-of-concept portion of the study and we we feel like, you know, it'll be a relatively small study will Target adult life easier to enroll than the childhood form and we don't think there will be any significant challenges at in the first phase of the study. Anyway given the size and the name.
Okay. Got you. Thank you, and we were also just wondering you saw this year if there's anything else that you're aware of that you're looking forward to.
Well, yeah, the oral session that we're in on Friday night will have I believe the NGM data and several other company presentations. So I will be a good session from think it's 4:30 to 6 or 4:30 to 6:30 on Friday night.
Okay, great. Looking forward to that. Appreciate taking your questions. Thanks. Our next question will come from David, please. Go ahead.
guilty of adults
Hey Brian, thanks for the update today. Now that you've got the safety be trial underway. I'm curious if that has affected your partnering discussions at all.
I mean it's a it's a fair question across the board in in the orphan setting but the most of these families are are seen at the same treatment centers that they they know that they. The the team.
It's a good question. No, not really. I think that everybody is kind of watching everybody else right now, but it hasn't had any impact on Thursday discussions.
Right. Okay, that makes sense. Cool. That's all I have. Thanks for answering my questions. Thank Sandy.
My next question will come from J. Olsen of Oppenheimer, please go ahead. Hey, thank you. Appreciate you taking our questions. This is Matt on for Jay. We were wondering I guess your thoughts on the evolving competitive landscape. For example, NGM just top-line their data from face to the other day. So if you got to take a look at that and any thoughts you might have their escape mechanism compared to the others out there and also maybe as a coil a what potential other combinations with other movies you could imagine being potentially helpful with yours. Yeah. Thanks for the question. I think it's better to direct the the questions about another company's data set to that company. I I thought that data looked real exciting and I've always thought that that compound looked very promising. I think the way we think about the competitive Advantage is 42809 our fax number.
Okay, and to I guess follow up on the previous question about the the data that came out this week. I guess I'm curious more general terms when you talk to kol. What is their view about saying injectable drug versus an oral drug treatment for Nash?
I think generally, you know, all things equal an oral is preferred and I think that having something that hits other lipid is is generally well well received in in our conversations with clinicians, but I think that after you have 19 and fgf21 mechanisms are are very a powerful and they've shown really exciting data. So I'm not going to take anything away from them. I I think that there is room for a lot of different mechanisms and a lot of different combinations of different mechanisms. And and we think that we will play a really significant role in in both single agent and combination settings.
Number one, it's oral. It's
The very effective on in in animals on fibrosis and humans on on liver fat and key differentiator for this mechanism is that month. You see a reduction across the board in plasma lip. It's not just LDL but also also after Jenny proteins and on top of that excellent tolerability with VK to it on I mean, there's no sort of a Jedi challenge or anything like that. That's very well-tolerated across the board. So I think we feel good about the competitive profile the more we see evolving off the space.
Okay.
Thanks for taking the question David.
Our next question will come from please go ahead and thanks for taking my question and congrats on the progress home. Maybe maybe backing on the previous comment for the 16-week follow-up a diesel. So I'm assuming is Addis PDF ever. Will there be other markers off? So you'd look at and and and the reason I ask is I think there is some data we're taking away the drug the liver fat drug actually brings back the fat off and and maybe other markers don't move as much so I'm just curious what mechanistically could be informative to using that. We're of drug wear off data off a diesel.
Okay. Got you. Thank you, and we were also just wondering you saw this year if there's anything else that's true except that you're aware of that. You're looking forward to.
Well, yeah, the oral session that we're in on Friday night will have I believe the NGM data and several other company presentations. So Thursday will be a good session from think it's 4:30 to 6 or 4:30 to 6:30 on Friday night.
Yeah, thanks, man. Well, we'll look at the PDF primarily and then look at some of the other subset at both weeks twelve and sixteen. I'm not sure what you're referring to in some of the other parts of Europe particularly or like yeah probably have that in there as well. I think yeah. Yeah probably have that in there as well. I was wondering if we reported that earlier but I don't think that was at the a sld presentation. That's right. Okay, and then on the on the design of face to be just curious like what like obviously you've borrowed it for the primary endpoint, but you said there's obviously a lot of other markers you looking at so could you maybe talk to like maybe your assumptions on Thursday?
Okay, great. Looking forward to that. I appreciate you taking your questions. Thanks our next question from David. Please. Go ahead.
Hey Brian, thanks for the update today. Now that you've got the safety be trial underway. I'm curious if that has affected your partnering discussions at all.
It's a good question. No, not really. I think that everybody is kind of watching everybody else right now, but it hasn't had any impact on Thursday discussions.
Okay, and to I guess follow up on the previous question about the the data that came out this week. I guess I'm curious more general terms when you talk to kol. What is their view about playing injectable drug versus an oral drug treatment for Nash?
How you thinking about the receiver there on?
They verified but also on the psychology and then like for the different devices, have you thought about powering the study? Yeah. Yeah, we well. We're we're extraordinary well powered on liver fat with the 75 seeing what we thought and Afghan in the prior study. We we are I think reasonably well powered on on the histology unless it's particularly resolution of Nash. I don't think we want to talk in more granularity about what those assumptions were, but we bought it from powering. I think we're assuming around 20% background rate of resolution and we're you know, we're powered to show a a Delta over that
I think generally, you know, all things equal and oral is preferred and I think that having something that hits other lipid is is generally well well received in in our conversations with clinicians, but I think that after you have 19 and fgf21 mechanisms are are very powerful and they've shown really exciting data, so I'm not going to take anything away from them. I I think that there is room for a lot of different mechanisms and a lot of different combinations of different mechanisms. And and we think that we will play a really significant role in a single agent and Company settings.
Okay.
Thanks for taking. Thanks David.
Okay, great. And and and just maybe one more on the is the background like what other medications are you allowing on the understudy as part of the protocol? Cuz I mean there are different studies as you know, she is going to be available starting June. You know, I mean, there's DLC ones already. So is this all allowing background therapies where you can maybe learn some combination data also? Yeah. This is a another important question right now. We're not allowing anything that we believe might play a role in the you know, efficacy an ethnicity signal for for Nash resolution or or fibrosis. So, you know any of the like pilot his own and and keep our costs are are excluded glp-1 Agonist are excluded anything that might Thursday.
Our next question will come from, please. Go ahead. I deem thanks for taking my question and congrats on the progress wage. Maybe piggybacking on the previous comments for the 16-week follow up at easel. So I'm assuming is this PDF ever? Will there be other markers off? So you'd look at and and in the reason I ask is I think there is some data we're taking away the drug the liver fat drug actually brings back the fat off and maybe other markers don't move as much so I'm just curious what mechanistically could be informative to using that. We're of drug. We're of data off a diesel.
Yeah, thanks, man. Well, we'll look at PDF primarily and then look at some of the other subset at both weeks that twelve and sixteen. I'm not sure what you're referring to in some of the other parts of Europe, but that's not really like yeah probably have that in there as well. I think yeah. Yeah probably have that in there as well. I was wondering if we reported that earlier but I I don't think that was at the a sld presentation. That's right. Okay, and then on on the design of face to be wired, just curious like what like obviously you've borrowed it for the primary endpoint. But you said there's obviously a lot of other markers you're looking at. So could you maybe talk to like maybe your assumptions on Thursday?
affect
Craig we've excluded may not we maybe do a lot of little bits of Triggs medication for trigger. But for the most part we're excluding anything that might modulate off my glycerides liver fat content and has shown efficacy in in other prior studies.
Okay, great and final question on the process for after you submit this 12-month data. Like how how does it work from here? Is it just a simple review and then Thursday and then they they respond within a 30 25-day time. Like what the process from here on yeah, there isn't an established process like when you file an agency or anything or NBA we will be submitting the report and then circling back after you know an appropriate time to check the status. But I am a little different here. There isn't a sort of a guideline for for hearing a response. We we do have a a pretty Wide Window between the submission and when anybody would cross the 6-month treatment threshold and we would certainly expect to understand, you know, fda's stance before anybody crosses that.
How you thinking about the deceiver there?
Verified but also on the psychology and then like for the different doses how you thought about powering the study. Yeah. Yeah, we well. We're we're extraordinary well powered on liver fat with the 70,000 seeing what we thought and Afghan in the prior study. We do we are I think reasonably well powered on on the histology points particularly resolution of Nash. I don't think we want to talk to in more granularity about what those assumptions were, but we bought on powering. I think we're assuming around 20% background rate of resolution and we're you know, we're powered to show a a Delta over that
at six month treatment threshold
Great. Well, actually one more for Greg. Is there a breakdown on preclinical span you could give 2018-2019 and maybe 20 20 like how you how to think about that long?
Yeah, I don't think we're we guidance Brian gave earlier I think is all worked up with we will see pickup and in the spend and both preclinical and clinical around numbers about 50% again over last year, but I think that's about all the granularity we have right now much more heavily planted to clinical.
Okay, great and and and just maybe one more on the just the background like what other medications are you allowing on the understudy as part of the protocol? Cuz I mean there are different studies as you know, she is going to be available starting June. You know, I mean, there's DLP ones already is Thursday to call a line background therapies where you can maybe learn some combination data also. Yeah, this is a another important question right now. We're not allowing anything that we believe might play a role in the you know, efficacy an advocacy signal for burnash resolution or or fibrosis. So, you know any of the like pilot his own and and keep our Agonist or are excluded glp-1 Agonist are excluded anything that might suck.
Excellent. Thanks guys. I'm glad on the progress again. Thanks, ma'am.
Our next question will come from Thomas Smith, please. Go ahead.
Hi guys. Thanks for taking my questions Brian. Can you just remind us I know the we just filed started member. But when was the first patient in the study then, I guess just following up on the the last uh question around FDA timelines, you know recognizing that there's no I guess established process established timeline that you're looking for. But when you do hear back from the agency, I guess if you could just let us know how you plan to communicate this, that'd be really helpful. Thanks. Yeah. I know we will probably give those updates on poorly calls or at the conference presentations as far as you know, meaningful Communications we received from the dead but it wouldn't be a separate Standalone announcement with respect to those seeing patients. We haven't provided that sort of dead.
affect
We've excluded maybe not we maybe do a lot of little bits of Triggs medication for Trig's but for the most part we're excluding anything that might modulate off my glycerides liver fat content and has shown efficacy in in other prior studies.
Okay, great and final question on the process for after you submit this 12-month data. Like how how does it work from here? Is it just a simple review and then off and then they they respond within a 30 35 day time. Like what's the process from here on yeah, there isn't an established process like when you file and Thursday or anything or NBA we will be submitting the report and then circling back after you know appropriate time to to check the status. But I am a little different here. There isn't a sort of a guideline for for hearing a response. We we do have a a pretty Wide Window between the submission and when anybody would cross the 6-month treatment threshold and we would certainly expect to understand, you know, fda's stance before anybody cross.
patient by patient details
We are actively enrolling and you know, that's that's about all the information that we're going to provide at this point. Okay, and then you mentioned Brian bringing the US trial sites online. What's your expected enrollment mix looking like patience?
Well, we would expect the vast majority to be in the US and you know, it's probably a four-to-one mix right now the way we have a thousand and four US versus X Us site but maybe the excuse nights might outperform the us if there's less competition, but right now we would we would assume the vast majority need to be uh from the USA.
Okay, great. Thanks for taking my questions. Thanks for question.
at six months of treatment threshold
Great. Well, actually one more for Greg. Is there a breakdown on preclinical span you could give 2018-2019 and maybe 20 20 like how you how to think about that?
Our next question will come from Julian Harrison of TIG, please go ahead.
Hi there. Thanks for taking my question and congrats and all the recent progress. Just curious if a cardiovascular risk reduction label is in the back of your mind at all or 8:28. 9. Would that be practical and may be helpful in the long run? Definitely understand see that they're not all undertakings, but it's hard to ignore that you're likely seeing more triglyceride-lowering than Recife ldl-c lower-income. That would have been great tolerability in virtually. No Alpha engagement on top of specific activity. Thanks.
Yeah, I don't think we're the guidance Brian gave earlier. I think all over with we will pick up in the spend and both preclinical and clinical around numbers about 50% again over last year, but I think that's the granularity you have right now much more heavily planted to clinical.
Excellent. Thanks guys. I'm glad on the progress again. Thanks, ma'am.
Our next question will come from Tom Smith, please. Go ahead.
Yeah, thanks. So we're not going to do a a dedicated cardiovascular outcome study unless unless we're at and there's no reason to think that we would but I think the the overall outcomes portion of of all of these studies includes the cardiovascular component all-cause mortality, but we took we at this point won't be seeking something like this whoever sit today.
Hi guys. Thanks for taking my questions Brian. Can you just remind us I know the voyage trial started in November. But when was the first patient in the study and then, I guess just following up on the the last uh question around FDA timelines, you know recognizing that there's no I guess established process often established timeline that you're looking for. But when you do hear back from the agency, I guess if you could just let us know how you plan to communicate this, that'd be really helpful. Thanks. Yeah. We will probably give those updates on poorly calls or at the conference presentations as far as you know, meaningful Communications, we received from the app, but it wouldn't be a separate Standalone announcement with respect to dosing patients. We haven't provided that sort of dead.
Great.
Thank you. Thanks again to ask the question, please. Press * then 1 or next question will come from Jason McCarthy of Maxim group, please.
patient by patient
Detail we are actively enrolling and you know, that's that's about all the information that we're going to provide at this point. Okay, and then, you mentioned Brian bringing the US trial site online. What's your expected enrollment mix looking like between us patience?
Well, we would expect the vast majority to be in the and you know, it's probably a four-to-one mixed right now the way we have a thousand and four US versus x u s type but maybe the XTS sites might outperform the us if there's less competition, but right now we would we would assume the vast majority need to be uh from the sides.
Okay, great. Thanks for taking my questions. Thanks for questions. Our next question will come from Julian Harrison of TIG, please go ahead.
Hi there. Thanks for taking my question and congrats and all the recent progress. Just curious if a cardiovascular risk reduction label is in the back of your mind at all or a $28. Would that be practical and may be helpful in the long run? Definitely understand see that they're not small undertakings, but it's hard to ignore that you're likely seeing more triglyceride-lowering than Recife ldl-c lowering phone bill Cassidy great tolerability in virtually. No Alpha engagement on top of specific activity. Thanks.
Yeah, thanks. So we're not going to do a a dedicated cardiovascular outcome study unless unless we're at and there's no reason to think that we would but I I think the the overall outcomes portion of of all of these studies includes the cardiovascular components all-cause mortality, but we at this point won't be seeking something like this whoever today.
Great.
Thank you. Thanks again to ask a question, please. Press * then 1 our next question will come from Jason McCarthy took everyone they on the line for Jason. Thanks for taking my question. I just wanted to quickly a circle back to you guys name starting potential interest in our defenses just for additional Clarity you guys mentioned that you believe it'll be about higher now. Is that for your 2020 compared to your life or is that more of a quarter-by-quarter basis?
It's it's for the for the full year and it the first quarter is going to be higher than the fourth quarter. Every every quarter will be a touch higher than the prior quarter. Okay, but the general applications at Apex and RD will be about 50% higher for for your 2020 versus full year and nineteen. Yeah, that's what our current estimates are. Ya. Okay. Great. Thanks for the additional Clarity. Appreciate it. Okay. Thanks a lot.
Will conclude our question-and-answer session at this time. I'd 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. You can disconnect all wheel now. Thank you.
The conference is now concluded and we thank you for attending today's presentation. You may now disconnect your line.