Viking Therapeutics Inc. Q1 2023 Earnings Call
Speaker 2: results conference call. At this time all participants are in a listen-only mode.
Speaker 2: Following management's prepared remarks, we will hold a Q&A session.
Speaker 2: To ask a question at that time, please press the star key followed by one on your touch tone phone.
Speaker 2: If anyone has difficulty hearing the conference, please press star zero for operator assistance.
Speaker 2: As a reminder, this conference call is being recorded today, April 26, 2023.
Speaker 2: I would now like to turn the conference over to Vikings Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.
Speaker 3: Hello and thank you all for participating in today's call. Joining me today is Brian Lein, Vikings President and CEO and Greg Zanti, Vikings CFO .
Speaker 3: Before we begin, I'd like to caution that comments made during this conference call, today April 26, 2023, will contain forward-looking statements under the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Vikings' expectations regarding its development activities, timelines, and milestones.
Speaker 3: 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.
Speaker 3: 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 Ryan Land for his initial comments.
Speaker 4: Thanks, Stephanie, and good afternoon to everyone dialed in by phone or listening on the webcast.
Speaker 4: Today, we'll review our financial results for the first quarter of 2023 and provide an update on recent progress with our clinical programs and operations.
Speaker 4: The first quarter of 2023 was an exciting time at Viking with important progress announced across multiple clinical programs.
Speaker 4: With respect to VK2809, our lead thyroid hormone receptor beta agonist for the treatment of NASH and fibrosis, early in the quarter we announced completion of enrollment in our Phase IIb voyage trial, and we expect to announce top-line data from the primary endpoint in this study in the second quarter of 2023.
Speaker 4: With respect to our newest clinical program, the dual GLT-1 and GIP receptor agonists, VK2735, for the potential treatment of metabolic disorders, last month we announced data from our first clinical study of this compound, a Phase I single ascending dose and multiple ascending dose study in healthy volunteers.
Speaker 4: As we'll discuss in a few minutes, the results were encouraging with mean weight loss of up to 18 pounds observed following 28 days of treatment.
Speaker 4: We plan to initiate a phase two study of DK2735 in patients with obesity in mid-2023.
Speaker 4: In addition, we announced the initiation of a new clinical study to evaluate a novel oral formulation of this compound.
Speaker 4: With respect to our third ongoing clinical program, the novel thyroid hormone beta receptor agonist VK0214, our Phase 1B trial evaluating this compound for the treatment of X-linked adrenoleukodystrophy continues to enroll, and we expect to report the results from this study in the second half of the year.
Speaker 4: Late in the quarter, we also completed the successful public offering of common stock, raising gross proceeds of approximately $288 million that we plan to use for the continued advancement of each of our programs through key clinical milestones.
Speaker 4: I'll provide further details on our operations and development activities after we review our first quarter 2023 financial results. For that, I'll turn the call over to Greg Zanti, Vikings Chief Financial Officer.
Speaker 4: Thanks, Brian . In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file today.
Speaker 4: I'll now go over our financial results for the first quarter ended March 31, 2023.
Speaker 4: Our research and development expenses for the three months ended March 31, 2023 were $11 million compared to $12.6 million for the same period in 2022.
Speaker 4: The decrease was primarily due to decreased expenses related to clinical studies, preclinical studies and third party consultants.
Speaker 4: Partially, I've said by increased expenses related to salaries and benefits, stock-based compensation and regulatory services.
Speaker 4: Our general and administrative expenses for the three months ended March 31, 2023 were 9.5 million compared to 3.7 million for the same period in 2022.
Speaker 4: The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and salaries and benefits.
Speaker 4: For the three-month-end in March 31, 2023, Viking reported a net loss of 19.5 million or 25 cents per share compared to a net loss of 16.1 million or 21 cents per share in the corresponding period of 2022.
Speaker 4: The increase in net loss and net loss per share for the three-month-set in March 31, 2023, was primarily due to the increase, general and administrative expenses noted previously, partially offset by increased interest income compared to the same period of 2022.
Speaker 4: cash, cash equivalents, and short-term investments totaling 135.7 million compared to 155.5 million as of December 31st, 2022.
Speaker 4: The company's Q1 2023 cash balance does not account for the completion of a public offering of common stock, resulting in gross proceeds of approximately $288 million that was completed at the end of the first quarter and closed on April 3, 2023.
Speaker 4: Pro forma, including this offering, our end-of-quarter cash, cash equivalents, and short-term investments were approximately 406 million.
Speaker 4: This concludes my financial review and I'll now turn the call back over to Brian . Thanks Greg.
Speaker 4: As mentioned in my opening comments, the first quarter of 2023 was an exciting time advising.
Speaker 4: In recent weeks, we announced positive data from a Phase 1 study in healthy volunteers with our newest clinical program, the dual-incretin receptor agonist, VK2735.
Speaker 4: These results, which I will discuss in more detail shortly, have served to broaden our presence in metabolic diseases and diversify our pipeline further increasing the value of the company.
Speaker 4: We are very pleased to begin the second quarter from a position of clinical momentum, financial strength and optimism for upcoming data.
Speaker 4: I'll now provide an overview of progress with our clinical programs, beginning with our lead compound, VK2809, for Nash and fibrosis.
Speaker 4: 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.
Speaker 4: A prior 12-week Phase II A trial evaluating BK-2809 in patients with hypercholestralemia and non-alcoholic fatty liver disease successfully achieved both its primary and secondary endpoints, demonstrating significant reductions in liver fat and plasma lipids.
Speaker 4: to 60% mean relative reductions in liver fat content and 88% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content. Importantly, the reductions in liver fat were durable with the majority of patients remaining responders four weeks after completion of dosing.
Speaker 4: This study also demonstrated the promising safety and tolerability of VK2809.
Speaker 4: No serious adverse events were reported and the rate of GI disturbances such as nausea and diarrhea was lower among VK 28090 treated patients when compared to patients treated with placebo.
Speaker 4: We believe DK2809's activation of the thyroid hormone beta receptor provides unique therapeutic benefits for patients with NASH.
Speaker 4: Perhaps one of the most important additional benefits of this compound is its ability to reduce plasma lipids, including LDL cholesterol, triglycerides, and aftergenic proteins, all of which have been correlated with increased cardiovascular risk. It is important to note that a number of studies evaluating other national development programs have demonstrated elevations in these lipids following treatment.
Speaker 4: In contrast, patients in Vikings 12-week Phase 2A study experienced robust reductions in these lipids, suggesting that VK-2809 may offer a cardio protective benefit. We believe VK-2809's broad lipid lowering properties combine with its safety, excellent tolerability.
Speaker 4: significant liver fat reduction and oral route of administration establishes as a best in class therapeutic for the treatment of Nash.
Speaker 4: Based on the promising results from our Phase 2A trial, the company initiated the voyage Phase 2B study.
Speaker 4: This trial 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. The target population includes 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.
Speaker 4: Up to 25% of patients may have F1 fibrosis provided that they also possess at least one additional risk factor.
Speaker 4: The primary endpoint of the voyage study was evaluate changes in liver fat from baseline to week 12 in patients treated with VK2809 as compared to patients receiving placebo.
Speaker 4: Secondary and exploratory objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.
Speaker 4: During the first quarter, we announced completion of enrollment in the voyage study and we look forward to sharing top line results, including the trial's primary endpoint, during the second quarter of this year.
Speaker 4: I'll now turn to our newest clinical program, highlighted by a compound called DK2735, which we believe has the potential for the treatment of various metabolic disorders such as obesity, NASH, and certain rare diseases. DK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor.
Speaker 4: the glucose-dependent insulinotropic polypeptide or GIP receptor.
Speaker 4: Initial in vivo data from our dual-agonist program demonstrated improvements in weight loss, glucose control, and insulin sensitivity among diet and duosobes mites following treatment with Vikings compounds as compared to a GLT1 monoagonist when administered at the same dose for the same period of time. In addition, the observed reductions in liver fat content were generally larger among animals treated with R
Speaker 4: The single ascending nose portion of the study enrolled healthy men and women.
Speaker 4: and evaluated escalating single doses of VK2735.
Speaker 4: The multiple ascending dose portion enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter squared. In the multiple ascending dose portion of the study, subject received VK2735 once weekly for 28 days.
Speaker 4: During the first quarter, we were pleased to announce the results from this study with VK2735 demonstrating promising safety, tolerability, a predictable PK profile, and positive signs of clinical benefit.
Speaker 4: P takeaways from the single ascending dose portion of the study were that single doses of VK2735 were safe and well-calerated and that the compounds PK profile demonstrated favorable characteristics in humans.
Speaker 4: Following single subcutaneous doses, VK2735 demonstrated the half-life of approximately 170 to 250 hours, a T-Max ranging from 75 to 90 hours, and excellent therapeutic exposures.
Speaker 4: In the 28-day multiple ascending dose portion of the study, DK2735 demonstrated encouraging safety and tolerability and positive signs of clinical activity.
Speaker 4: All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline ranging up to 7.8%.
Speaker 4: So, we're receiving BK2735 also demonstrated reductions in mean bodyweight relative to placebo, ranging up to 6%.
Speaker 4: Statistically significant differences compared to placebo were maintained or improved at the day 43 follow-up time point 21 days after the last dose of DK2735 was administered.
Speaker 4: Importantly, VK2735 demonstrated encouraging safety and tolerability following repeated those things.
Speaker 4: 98% of observed adverse events were reported as mild or moderate, and 99% of gastrointestinal related adverse events were also reported as mild or moderate.
Speaker 4: In addition, all cohorts treated with VK2735 demonstrated improvements in plasma glucose levels relative to placebo, though not all cohorts achieved statistical significance.
Speaker 4: We believe the tolerability data from this study indicates that higher doses may be achieved with longer titration windows, and we plan to evaluate further dose escalation in subsequent studies.
Speaker 4: Turning to our future plans for VK2735, based on the positive results generated in the Phase I study, we plan to initiate a Phase II trial in patients with obesity in mid-2023.
Speaker 4: Concord with the announcement of the Phase I data just described. We also announced the initiation of a Phase I clinical study to evaluate an oral tablet formulation of VK2735.
Speaker 4: We believe the tablet formulation represents a significant potential expansion of the program's overall value and utility.
Speaker 4: In vivo data to date, they suggest that therapeutic plasma levels of VK2735 may be achieved via oral dosing, and we expect both sub-contaneous formulation and the oral formulation to provide unique benefits to patients.
Speaker 4: The ability to select either subcutaneous or oral dosage forms of VK2735 creates attractive potential treatment options and further extends the reach of this important program.
Speaker 4: The oral study is an extension of the Phase I study discussed a moment ago.
Speaker 4: This 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.
Speaker 4: Subjects will receive daily oral doses 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.
Speaker 4: Exploratory endpoints include changes in body weight and plasma glucose.
Speaker 4: We believe the results from this study could potentially be available in the second half of 2022.
Speaker 4: I will now provide an update on our third clinical candidate, VKO214.
Speaker 4: This is Viking 2nd orally available small molecule thyroid homeowner's septal beta agonist.
Speaker 4: And it is currently being evaluated in a Phase 1B clinical trial in patients with X-linked adrenalin-digit dystrophy or XLD.
Speaker 4: XLD is a rare and often fatal metabolic disorder. Patients with XLD have genetic mutations that impact the function of a paroxysomal transporter of very long chain fatty acids.
Speaker 4: When transporter function is impaired, patients are unable to efficiently metabolize very long chain fatty acids.
Speaker 4: And the resulting accumulation of these compounds is believed to contribute to the onset and progression of XLD.
Speaker 4: In a prior phase one study in more than 100 healthy volunteers, VKO214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once daily dose-dependent.
Speaker 4: Subject to receive VK0214, experience reductions in LDL cholesterol, triglycerides, apolipolibroting B and life of protein A.
Speaker 4: VKO214 also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose-related signals observed for GI side effects, vital signs, or cardiovascular measures.
Speaker 4: Following these favorable results, Viking initiated the Phase I B study of VKO214 in patients with the Adreno-Mile in Aeropathy or AMN form of XLD.
Speaker 4: AMN is the most common form of XLD affecting approximately 50% of patients.
Speaker 4: The Phase I B trial is a randomized, double blind placebo controlled multi-center study in adult male patients with AMF.
Speaker 4: The primary objectives of the study are to evaluate safety, tolerability, and pharmacokinetics of VKO214, administered once daily orally for 28 days.
Speaker 4: The study also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids. This study continues to enroll, and we expect to report the initial results later this year.
Speaker 4: Moving to other corporate updates, laid in the first quarter, we completed a successful public offering of common stock, raising gross proceeds of approximately 288 million.
Speaker 4: We were happy to see the receptivity and enthusiasm from investors and are grateful for their support as we continue advancing our pipeline programs.
Speaker 4: As Greg mentioned earlier, pro-former for the offering our end-of-quarter cash balance was approximately 400 million.
Speaker 4: This enables the company to further invest in pipeline programs, both existing and new, and places Viking in a position of strength in discussions with potential corporate partners.
Speaker 4: In conclusion, the first quarter of 2023 proved to be an exceptional quarter for Viking.
Speaker 4: We now ask completion of enrollment in the FOIAD study of VK-2809 in patients with National????
Speaker 4: And we expect to report data for the primary endpoint of this study later this quarter.
Speaker 4: We also announced the first human data from our dual GLP1 GIP receptor agonist VK2735, demonstrated promising safety and tolerability and exciting reductions in body weight.
Speaker 4: We look forward to initiating a US Phase II study in obesity in mid-2023.
Speaker 4: We also further expanded the reach of this program by announcing the initiation of a study using an oral tablet formulation, from which we expect to report results toward the end of the year. With our VK0214 program, we continued enrolling our Phase 1B study in patients with adrenomyoneuropathy.
Speaker 4: and we anticipate reporting data from this study later in the year. Finally, we significantly strengthened our balance sheet in the quarter through a successful offering of common stock, which resulted in proceeds of over $280 million.
Speaker 4: Our current runway extends well beyond each of the clinical catalysts outlined here.
Speaker 4: We feel fortunate and grateful to be in the position we're in and look forward to providing additional updates as they're available. This concludes our prepared comments for today. Thanks again for joining us, and we'll now open the call for questions. Operator? Thank you. We will now begin the question and answer session.
Speaker 2: To ask a question you may press start at the one on your touch time phone.
Speaker 2: If you're using a speakerphone, we ask that you please pick up your handset before pressing the key. To withdraw your question, please press start when you're ready.
Speaker 2: Today's first question comes from Steve Seedhouse with Raymond James. Please go ahead.
Speaker 5: Great, thanks so much for taking the questions. I had a few on the oral formulation of the GLP1-GIP.
Speaker 5: First, you haven't shared any preclinical data, so I wanted to ask in general if the expectation would be you could get the sort of exposure and ultimately efficacy levels that would be equivalent to the injectable or what specifically would be the expectations in terms of potency of what you could.
Speaker 5: achieve at peak in humans. And then also with that compound, is this something that would lend itself to like a titration scheme as well, or are you essentially looking at flat doses in the phase one? Hey, Steve. Thanks for the questions.
Speaker 4: with the exposures. Yeah, I don't think we expect the exposures to achieve the same level that are observed with the sub-Q formulation. Maybe I'll be proven wrong, but I don't think we'll get there. It's almost a different product. I would consider the oral formulation.
Speaker 4: maybe for someone who first doesn't want to start with an injectable or for someone who maybe has a BMI 32 to 34 or something that...
for someone who first doesn't want to start with an injectable, or for someone who maybe has a BMI 32 to 34 or something that might be...
adequately addressed with an oral formulation or potentially in a maintenance setting where you start with the sub-q and then transition on. So there are a lot of different ways that it could be used, but my own guess is that we probably won't see the same exposures with the oral.
population or potentially in a maintenance setting where you start with the sub-q and then transition on. So there are a lot of different ways that it could be used, but my own guess is that we probably won't see the same exposures with the oral. What's the same question?
Oh, titration, yeah. So yeah, we will titrate in the upcoming study. So the first cohorts, flat dosing and subsequent cohorts will titrate up.
Okay, so it's just one dose of one tablet dose that you just give multiple pills, I guess.
In that case, right? Yeah. Yeah. Yep. The first the first cohort is
two and a half megs and that's flat and then from there they dose up. I mean first week will be two and a half and then the remaining three weeks would be a higher dose and then as you go on in through the cohorts you kind of tight trade up per week.
flat and then from there they dose up. First week will be two and a half and then the remaining three weeks would be a higher dose and then as you go on through the cohorts you kind of tight trade up per week.
Okay, a couple more, because it's a really interesting program. Obviously, you mentioned maintenance, noticing as one talk, and that's just given how many people in the next.
you know decade are likely to be gravitating towards using cretins I imagine there'd be some enormous
group of patients comment on or
You know, having been on injectables, I'm curious if you're going to gather that type of maintenance data in the Phase 1. Can you take patients that you already treated with the injectable and start them on oral and see how they do?
And then I just have one more in the program after if I put it. Thanks. Yeah. Now thanks. In this study, we're really just trying to see if the formulation will provide exposures and, you know, enough. Three possibly. We're doing that today. As they say on the low, you are indeed so sweet.
what levels compare to the subcue. So I think in the future, you know, those transition type studies would be really important and really interesting, but this is just the first one and we're just going to see how the exposures turn out.
Okay, and then the phase one, I think you guys were pretty injectable, at least you were collecting MRI, PDFF data, and there were maybe some other biomarkers in there that weren't ready for the initial top line. So can you just comment on, you know, you have the guidance in place for the oral data, is there any other data either from the clinical injectable study?
You know, beyond the top line that you've already announced that would be coming here in your term that we should keep an eye out for. Thanks. Yeah, thanks, Steve. We'll probably be reporting more data a little bit later in the year potentially at obesity week, but we don't have any near term.
you know, nothing imminent there. But you're right, we did have a number of biomarkers of liver fat in the study.
All right, thanks, Frank. Thanks, Steve. Thank you. And our next question today comes from June Lee. What's your securities? Please go ahead.
Hey, thanks for taking our questions and congrats on the progress. What really stood out from the Healthy Volunteer Study of DK2735 was how clean the probability profile was. So is that just a function of the study being a small phase one study or is there some mechanistic hypotheses as to why?
2735 may be better tolerated and with possibly better weight loss and have a follow-up. Thank you.
Hey, June , thanks. Yeah, so I don't really know. It was a small study, so you could argue that maybe we're just looking at small numbers. What was interesting with the tolerability was that there wasn't really a dose-related change in tolerability as you went up. I think the highest dose cohort actually had really, really good tolerability better than
arrest and recruitment, you could see maybe an increase in efficacy without necessarily issues with nausea, but I don't know. Otherwise, I don't know the mechanistically, there's anything obvious that would explain it.
Fair enough. And you know, both the Lee and the O'Hat historically had to have had to have trials of their GLPs at least for diabetes. Do you have any plans to do a head to have trial of BK2735 against other obesity drugs? Okay.
Yeah, great question. I think it's a really good idea as we move further through the program, but this upcoming Phase 2 will not have an active comparator in it. It's just placebo. I do think that's something important for the future just to see how they compare.
Thanks, June . Thank you. And our next question today comes from Annabel Samui with Steve Hall. Please go ahead.
Hi, thanks for taking my question. So I want to ask about the titration period that you're considering for Phase 2. I mean already it looked like you had some good tolerability. It looks like you have some very good weight loss already within 28 weeks. So I guess I'm wondering why you would want to push that further.
and what kind of titration schedule might we be looking at? So I guess that's the first question. And is this the same exact molecule as 2735? Are you changing the balance between GLP-1 or GIP in any way as you go into the oral if you don't have the same, I guess, target exposure?
And then I have one more follow up. Yeah, it's the same molecule, Annabelle, in the oral and the sub-Q. And we're titrating in the 28-day study.
really because we've not dosed with this compound before so we don't know if there are any differences in taller ability and we're doing fewer cohorts so in the sub queue we did have the first two cohorts were flat dosing and then we titrated and here the first cohorts can be flattened and we titrate but nothing obvious that suggests we have to titrate and to your point
I think the tolerability was really, really promising in the subcue, but it's just, you know, its first study. We know that GFU1 agonism is tied to nausea and GI side effects, so we just want to try to control for that as best as possible. I guess, you know, to be more specific, why do you feel like you need to go higher on the dosing? If you sort of attain some of some pretty competitive results as it is with good...
and we were considering adding that 15 milligram cohort to the 28 day study, but we decided to just stop the study here and put that into the phase two, and we'll tighten it up to it. But I don't think there's anything, I don't think we're necessarily pushing anything with increase in the dose to 15.
And then if I can ask on VK2809, I mean, you have some pretty good validation from a competing program, but I guess some of the KOLs we spoke to, one of the things that they brought up was that they were a little bit surprised that there was not just NASH reduction, but they also were able to show fibrotic improvement as early as year one. So how do you...
reflection.
Well, I don't know. I think the, yes and no, I guess. I mean, the fibrosis improvement endpoint is traditionally a more difficult.
end point to show improvement on. But we know that the mechanism demonstrates in animal models reduction in college and load and improvement in fibrosis. And whether or not that secondary to fat reduction, I don't think we know and haven't seen that published anywhere.
We weren't totally surprised. I guess you could argue that...
It's too short of window and this is more metabolic targeting mechanism, but everything we've seen in animals suggests that it should actually do both. It should help with natural resolution and improve fibrosis.
Okay, great. In fact, I can squeeze in one more. Any thoughts about how long this 406 million will take you out to? Yeah, hi, Annabelle. You know, certainly we're covered as Brian mentioned earlier, you know, well beyond all the catalysts in our three development programs. think. Welcome to. Great.
We wouldn't point to the exact year, but certainly well beyond two years out and well beyond.
Okay, great, thank you. Thanks, Edel. Thank you. And our next question today comes from J. Olson at Oppenheimer. Please go ahead.
Oh, hey, congrats on all the progress and thank you for the update. Maybe just to follow up on VK-2809. Can you just talk about what we should expect to see in the top line results besides MRI, PDFF will receive?
for your molecule and then I had to follow up if I could please.
And a lipid panel, so likely LDL, Triggs, and if we get the afterogenic proteins, L-P-L-A and APOB, we'd report those as well, as well as safety and tolerability. The GI profile to date has been excellent. We haven't really seen anything different from placebo.
And there's no reason to think that we would see differences in the voyage population, but we don't have the data, so can't say for sure yet. But there's nothing that would lead us to believe that there would be any sort of a GI signal with the compound. It's exceptionally well tolerated. Okay, great. Thank you. That's super helpful. And then if you could maybe help.
is the most important differentiating points from ResMeduron. Yeah, thanks, Jay. Well, I think the internal hurdle that we're using is a 30% mean reduction in liver fat. If we can see, you know, treatment groups showing a 30% mean reduction.
That would be our success hurdle. Obviously, higher is better. We saw really nice reductions in the Phase II A study. I'm not sure I would expect that level of efficacy in this study just because it's a larger study. And you often see a penalty when you're in larger populations. But if we see 30%, I think there's a lot of precedent that suggests that translates to a higher probability of histologic benefit.
I think there's plenty of room for multiple of the same mechanism to coexist in NASH. I think there will be differentiation among products and they're probably switching. I think our tolerability profile is outstanding and our efficacy has been exceptionally strong so far. So, I think we're comfortable with where we would be competitively.
Excellent, thank you so much for taking the questions and we'll look forward to seeing the results.
Excellent. Thank you so much for taking the questions and we'll look forward to seeing the results. Thanks very much, Jay.
Thank you. And our next question today comes from Andy Sey with William Blair. Please go ahead. Great. Thanks for taking my question and congratulations on all the achievements this quarter. So Brian , you mentioned a couple of times about the activities in Lipper Fat, at least in the preclinical model from these dual agonists.
It's thanks, Eddie. I think the liver fat change from this mechanism, because there are no receptors in the liver is probably most tied to...
weight loss and insulin sensitivity, improving insulin sensitivity. So I don't think there's necessarily a direct effect on liver fat. It's more tied to...
to weight loss. But in animals, we did see really interesting data. Typically, generally, always better than a GLP1 monoagannist and comparable to better than another dual agonist. So we're really excited about the potential there.
I think that the models we looked at were generally the diet and do so beast mouse. So if you're skinnier or your body weight lower, liver fat is lower, you probably wouldn't see as large an effect since the effect is driven by weight loss. But...
Pretty interesting, characteristic. Got it. We've got some questions from investors about relative contribution of weight loss from either fat or lean body mass. Do you have a good handle from the Phase I study?
about the proportion that's the observed weight loss is coming from. We don't. We didn't do any dexas cans in this study, so we don't have the relative change in weight. We do from the animals we saw predominantly a reduction in fat. We don't have the relative change in weight loss.
and not muscle. But I think it's been shown in other studies that when you lose a certain amount of weight you do start to cut into muscle. But we didn't see that in any of the animal studies that we conducted. And we unfortunately just didn't look at it in this study. Great. Is that something you'll look at? You'll look at it. You'll look at it.
relation versus sub-Q. Could you kind of help us think about the amount in terms of dosing from these two formulations on a relative sense? Yeah, the oral will push up a little bit higher. We're going, I think the plan is to go to 20 milligrams with the oral, so not a huge amount higher than the...
to turn it on with land dose for the phase two in the sub-cute. Got it. Okay. Awesome. Well, thanks for answering all our questions.
I'm currently planning those for the Phase 2 and the sub-Q. Got it. OK. Awesome. Well, thanks for answering all our questions. Thanks a lot, Andy.
And ladies and gentlemen as a reminder if you would like to ask a question please press star then one. Our next question comes from Yale Gen with Lay-Bong Company. Please go ahead. Good afternoon and thanks for taking the questions and congrats on the profits of Bob. Just a quick few quick questions.
First one probably is in the past speaking in terms of SG&A in first quarter that seems to significantly higher than prior quarters. Should we anticipate that to be a normal this is generally a one time situation.
Yeah, thanks, Joe. That's primarily due to... It is not something you should expect to see moving forward. That's really due to the timing of some legal expenses, and those should be reduced moving forward, and you wouldn't expect that to be the runway moving forward.
Okay, great. And a follow-up question here, again, about the 2735 Phase II study. Could you give us sort of overall for a review about what you anticipate to do for that study and anything you can review in terms of this?
study design? Yeah, the study design is a 13-week study with flat dosing in the lowest dose cohorts and then titrated dosing in the higher dose cohorts. The top dose right now is
targeting 15 milligrams. And we'll do step-wide titration up there. It's 13 weeks in duration, so you'd be at the top dose for, I think, three to four weeks at the end there. The primary endpoint will be change in body weight. And how big the study might be in terms of size.
Yeah, we haven't disclosed that, but I would say, you know, 150 or so or, you know, one to 100 to 150 would be the target there. And great, that's their help. Maybe the last question here is that you mentioned that about with a cash in hand.
You might also contemplate some additional pipeline expansions. I know you want to be focused, but nevertheless, was there anything in your mind that could be exploited and going forward? Yes, we have a lot of things that we're working on, but we're
is a good example of that and as things mature appropriately we'll have more to say about them.
Okay, great. That's all I have to get in Congress. Thanks a lot, Jim. Thank you. And our next question today comes from Justin Zell and not with BTIG. Please go.
Hi, thanks for taking the question and congrats on all the progress. Maybe just to follow up on the Phase 2 for the dual lagnus here, you mentioned 13 weeks of effective dosing. Will you continue to follow up the patient's past 13 weeks and further?
longer term data would we have to look towards another study here and I have some follow-ups. Yeah, I think longer data would come from a subsequent study of 26 weeks or longer. Not that that's the next study, but we plan to get through this study first. The follow-up period in this study I believe is four weeks, so you come back.
profile that suggests that it might be different from what we've seen with the Teresapita compound. I'm just curious if there was anything that appeared in that data set yet or is it too early to tell.
Yes, it's really hard to make those comparisons because the, obviously they weren't head-to-head in the population that we've seen published for us.
The TREZEPTITEC compound is just a different population than we looked at We do see I think a later team acts a longer half-life and I think our exposures are Improved but again very difficult to make those sorts comparisons in the absence of a head-to-head data set I'll ask one last question
Further down the road, do you see any potential to run a combination with 2809 and the dual-lagonist potentially in a NASH study? Yes, it's not something we've talked much about, but if we were to do something like that, I think we'd talk about it if and when we had data on it.
Do you see any potential to run a combination with 28.9 and the dual-lagnest potentially in a Nash study? Yeah, it's not something we've talked much about, but if we were to do something like that, I think we talk about it if and when we have data on it. Great, thanks for taking my questions.
Thanks, Jeff. Thank you. And our next question today comes from Nas Rahman with Maxim Group. Please go ahead.
Hi guys, thanks for taking my question. Just really quickly on the oral, what gives you confidence on the timing of the initial data for second half of 23? Like are you guys seeing any potential competition or any issues with creating patients with all the, I guess, various GLP-1 studies ongoing?
But I don't know, we haven't had many competitive issues at this point.
Great. How many sites are there and for this study are all the sites also in Australia? Yes, it's actually an extension of the...
Earlier study, the single ascending dose and multiple ascending dose study, it's the same site that's the single site in Australia. The Phase II study will be here in the United States.
Are you seeing like I guess like faster rates enrollment or I guess like higher rates of interest versus when you initially started your injectable studies?
Oh, I think it's maybe too early to say there. I don't know the answer to that question. Oh, come on. Got it. Thank you for taking my questions.
I think it's maybe too early to say there. I don't know the answer to that question. Got it. Thank you for taking my questions.