Q1 2023 Altimmune Inc Earnings Call
Yes.
[music].
Okay.
Good day, ladies and gentlemen, welcome to the Ulta Beauty, Inc. First quarter 2023 financial results Conference call.
At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time to ask a question. During the session you will need to press star one one on your telephone.
As a reminder, this call is being recorded I would now like to introduce your host for today's conference call Rich Eisenstadt, Chief Financial Officer of Ultra Man Rich you may begin.
Thank you J J and good morning, everyone. Thank you for participating in <unk> first quarter 2023 financial results and business update conference call.
Members of the all three team and joining me on the call today are different guard, our Chief Executive Officer, Scott Roberts, Our Chief Scientific Officer, Scott Harris, our Chief Medical Officer.
Following the prepared remarks, where order question and answer session.
A press release with our first quarter 2000, 2030 financial results was issued this morning can be found on the Investor Relations section of the company's website.
Before we begin I would like to remind everyone that remarks about future expectations plans and prospects.
Forward looking statements for purposes of Safe Harbor provisions.
Private Securities Litigation Reform Act of 1995.
<unk> cautions that these forward looking statements are subject to risks and uncertainties that could.
Could cause actual results to differ materially from those indicated for discussion of some of the risks and factors that could affect the company's future results of operations. Please.
You see the risk factors and other cautionary statements contained in the company's filings with the SEC.
I would also direct you to read the forward looking statement disclaimer in our press release issued this morning, and now available on our website.
Any statements made on this conference call speak only as of today's date Thursday May 11, 2023, and the company does not undertake any obligation to update any of these forward looking statements.
<unk> events or circumstances that occur on or after today's date.
As a reminder, this conference call is being recorded and will be available for audio replay on <unk> website.
I will now turn the call over to Dr. Guyer, Chief Executive officer of Alchemy.
Thank you Rick and good morning, everyone.
We appreciate you joining us today for a discussion of our first quarter 2023 financial results and business updates.
We continue to advance our lead product candidate <unk> type a.
<unk>, one glucagon dual receptor agonist in development for both obesity and Nash.
Last year via <unk>.
<unk> compelling 24 week data from our trial in subjects with Max LTV.
We plan to initiate the impact phase two B Nash trial midyear 2023.
Yes.
We believe that the effects of Perm did do tight on liver fat a class leading.
We also believe yes.
<unk> is the only Nash candidate in development that combines robust reductions in both liver fat and body weight.
This is extremely important because nash patient sub products not only from the complications of liver disease, but also from the underlying profit muscle obesity, a principal driver of Nash.
Harriss will provide more details on the impact of trials shortly.
With regard to obesity.
We look forward to reporting topline 48 week data loss data from our phase III momentum obesity trial in the fourth quarter of this year.
The momentum interim results of 100 160 subjects reported earlier this year.
Weight loss of 10, 7% at the two four milligram dose and 94% SD one eight milligram dose compared to 1% weight loss in subjects, receiving placebo after only 24 weeks.
These robust reductions in body weight.
Together with the effects of bandwidth tied on serum lipids and blood pressure.
Yes <unk>.
<unk> has the potential to be an important treatment options for patients with obesity, especially individuals with naphtha.
And Dyslipidemia.
Finally.
Enrollment in the phase II clinical trial of <unk> T cell in chronic hepatitis B is now complete.
And we expect to have a data readout in the first quarter of 2024.
Recall that this trial is designed to show evidence of antiviral effect.
<unk> HBV and established its role in combination therapy for the treatment of this important disease.
We're excited about the progress of <unk>.
And the upcoming Readouts of these ongoing trials with that I will now.
Ill turn the call over to our Chief Medical Officer, Dr. Scott Harris will discuss our clinical glass stock.
Thank you vipin and good morning, everyone.
First let me start by reviewing the clinical path plans for impact Phase III Nash trial.
This biopsy driven Nash trial will be conducted at approximately 60 sites in the U S with Dr. Stephen Harrison Medical director of clinical research and adjunct Professor of Medicine, Oxford University.
Serving as principal investigator.
To be eligible for study participation subjects will be required to have a BMI of at least 27 kilograms per meter squared.
Our liver fat content of at least 8% as measured by MRI PD FF and therefore, the activity score of at least four on a pre treatment biopsy and either <unk> two or three fibrosis.
At least 50% of the subjects will be required to have F. Three fibrosis.
Subjects, both with and without diabetes will be enrolled.
And our two earlier natural D trials. The two four milligram dose did not materially improve liver fat reduction or CET. One response over the one eight milligram dose and the two four milligram dose will not be evaluated in this trial.
Subjects will constantly consequently be treated with Panther II tied one two milligrams Panther do tied one eight milligrams or placebo.
We are planning for approximately 190 subjects to be enrolled in the impact trial in a one to two to two randomization scheme with subjects stratified for fibrosis stage and the presence or absence of diabetes. Therefore approximately 36.
Subjects are expected to receive <unk>, one two milligrams 76 subjects Panther do Todd one eight milligrams and 76 subjects placebo.
The primary endpoints of the impact trial will be dual endpoints of achieving either.
Cash resolution with no worsening of fibrosis.
Or fibrosis improvement with no worsening of Nash with the primary treatment comparison being in the one eight milligram dose versus placebo.
Secondary endpoints will include weight loss liver fat reduction by MRI PD FF CET, one response rate serum lipids and noninvasive biomarkers of disease.
All endpoints will be assessed at week 24 of treatment and subjects will continue to be dosed and followed for an additional 24 weeks to a total of 48 weeks for safety and additional biomarker responses.
Our algorithm for biopsy reading and adjudicate communications Leverages the experience of other recently completed Nash trials, which we anticipate may optimize the likelihood of <unk> achieving robust endpoint responses.
Plan has been developed to correlate noninvasive tests with Nash resolution and fibrosis improvement biopsy endpoints and have commenced discussions with FDA about the use of these biomarkers as primary endpoints in phase three we remain on target for the trial to commence mid year.
And to report top line results in the first quarter of 2025.
This reduction will be made available to subjects, who experience Gi intolerance. The Panther <unk> was well tolerated in our two previous trials in subjects with natural D.
Now, let me talk about the phase III momentum trial of <unk> in obesity.
The trial was designed to enroll approximately 320 subjects without diabetes, but with obesity or overweight with at least one comorbidity.
Dr. Lu of Roni, the Weill from Wild Cornell Medical School, a leading authority.
Obesity and obesity clinical trials is serving us as the principal investigator.
Subjects were randomized one to one to one to one to one two milligrams one eight milligrams two four milligrams of <unk> or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
A prespecified interim analysis was performed one 160 subjects completed 24 weeks of treatment.
Weight loss of 10, 7% at the two four milligram dose at nine 4% at the one point of element eight milligram dose was achieved compared to 1% weight loss in subjects receiving placebo.
Approximately 50% of subjects achieved at least 10% weight loss and approximately 20% of subjects achieved at least 15% weight loss by week 24 at the $2 four and one eight milligram doses.
The adverse event discontinuation rate at the two four milligram dose was higher than observed in our four prior trials with Perm to do Todd, but similar to the adverse event discontinue rates and similar phase II trials of other anchor 10 based agents.
We believe that the Gi adverse discontinuation rate can be mitigated to low levels in future trials of <unk> through the use of dose reduction.
We look forward to our top line results from the momentum trial in the fourth quarter of this year.
We expect to see continued weight loss beyond the double digit levels noted at our 24 week interim analysis.
Other topline readout parameters will include adverse events vital signs serum lipids glucose control and study discontinuation.
Also as we previously announced we have completed the enrollment in our phase II multicenter clinical trial of Hep T. So in patients with chronic hepatitis b.
Chronic hepatitis B continues to represent a serious unmet need in the U S and worldwide and represents a significant commercial opportunity.
The F. T cell trial was designed to enroll approximately 80 subjects with an active chronic hepatitis b and low hepatitis b surface antigen or hbsag.
And to evaluate the efficacy of <unk> monotherapy as measured by a reduction in Hbsag and other virological markers of infection. We.
We expect to announce the results of this trial in the first quarter of 2024 once all subjects completed the six month treatment period.
It is generally believed that an effective therapy for chronic hepatitis b, we will require both direct acting antivirals in immunotherapy and we believe that Hep T cell could be combined with novel direct acting antivirals in this treatment strategy.
I'll now hand, the call over to Ritch Allison start to give an update on our third quarter financial results rich.
Thank you Scott and good morning, again for today's call I'll be providing a brief update on <unk> first quarter 2023 financial and operating results more comprehensive information will be available on our Form 10-Q to be filed with the SEC later today.
<unk> ended the first quarter of 2023 with approximately $165 $8 million of cash cash equivalents and short term investments compared to $184 $9 million at the end of 2022.
Research and development expenses were $17 2 million in the first quarter of 2023 compared to $15 1 million in the same period in 2022.
Approximately $10 $8 million of this total for the first quarter of 2023 or direct expenses for the conduct of our clinical programs, including $8 $7 million in direct costs related to development activities for <unk> and $2 $1 million in direct cost related to development activities per FTE.
T cell <unk>.
General and administrative expenses were consistent period over period at $4 5 million at $4 $4 million, but of the three months ended March 31, 2023 at March 31 2022, respectively.
Interest income was $1 $7 million for the three months ended March 31, 2023 and was negligible in the three months ended March 31 2022.
Net loss for the three months ended March 31, 2023 was $21 million or <unk> 40, <unk> net loss per share compared to net loss of $19 $4 million or <unk> 44 net loss per share.
First quarter of 2020.
We estimate that our existing cash funds us through the 24 week biopsy results from our impact phase <unk> trial expected in the first quarter of 2025.
Our financing also funds completion of the 48 week momentum trial.
T cell trial, our current cash projection includes no funding for the initiation of the PCB.
PCB campaign, which would only commence with a partner.
I will now turn it back over to <unk> for his closing remarks.
Operator that concludes our formal remarks, and we would like to open the lines to take questions could you. Please instruct the audience on the Q&A procedure.
Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again.
Our first question comes from the line of Seamus Fernandez from Guggenheim Securities.
Great. Thanks for the question so.
Richard in your remarks, you commented that.
Paul and advancement into phase III obesity.
Would.
Require a partner can you just help us understand.
How.
And rich if you can both help us understand how you're thinking about.
A potential partner here, given sort of overlapping dynamics of Nash and obesity.
And then separately.
Just maybe remind us what you are hoping to see in the <unk>.
Broader.
Clinical dataset.
From the momentum study when we receive that at 48 weeks and the importance of those data to a potential partner. What you believe partners are looking for in that data set or potential partners might be looking for in that data set to.
To move forward. Thanks.
Yes. Good morning, Thank you for the question.
So as you know both for Nash and obesity, both large market and we believe will benefit from having a partner for both of these indications. So our goal is to have a partner product for the phase III initiation up by the time, we are ready to start phase III.
Obesity and in parallel we will also discuss with partner joining forces with regards to Nash as well.
Ultimately our goal is to have a partner that has the resources and can bring value to both of these indications because ultimately in order to market.
For both of these indications will need a partner so we will explore a partnership across both of these asset if it turns out that initially the partnership is only centered around obesity.
Downstream prospect.
After including masks.
<unk> will explore all of those options that in multiple ways of doing these partnerships.
Obviously, we have embarked on a case to be planned for Nash and that data will become available in due course, so all of those items.
It will sort of play a role in terms of ultimately designing the optimal structure for their partnership and on both of these indications.
Yes.
With regards to the data.
As you know we announced.
We announced the 24 week data and again, our board has been engaged in partnership discussions on the back of that data.
Nearly partners will also be looking for the 48 week data as we are at least some partners would want to see the 48 week data. We expect to continue to show additional weight loss and I think that would be very important as we go into partnership discussions.
For this year.
Great and then.
Yes.
I wanted to reconfirm.
The timing of the Nash 24 week.
Results I think previously David that you anticipate having those results.
On time in the first half of 2025.
Just wanted to.
C.
You are getting closer to the initiation of the phase two.
How those timelines are continuing to shake out.
I will jump back in the queue. Thanks.
Yes.
Timeline is looking good we think we can get back those results in the first quarter of 2025 and Thats. What we are guiding to at this point, so we feel very comfortable saying that.
The trial showed stocks yet.
Few weeks or a couple of months and basically based on our analysis of the time it will take to enroll subjects and keep them first quarter of 2025 would be a reasonable timeline.
Great. Thank you.
Thank you one moment for our next question.
Our next question comes from the line of Yasmin Rahimi from Piper Sandler.
Hi, good morning team and thank you so much for all of these have also been really outstanding Nash trial design.
So you I think the first one is along with let Sheamus was asking Mike in regards to discussions that.
In regards to the profile of <unk> do you have a feeling for.
What type of weight loss do they want to or see a competitive at week 48. That's question one.
And then question two is.
Could you maybe speak a little bit about the nature of the biopsy handling and the study will you have to either.
Well DB in pairs, so heavy sort of logistical details around the reading and then the third question is if you could just comment on.
What niet's are being utilized at baseline for screening the patients and creating a homogeneous population and I'll jump back into the queue and thank you again for taking my question.
Yes, good morning des.
Yes, yes. Thank you and thank you for the question I'll take the first part of your question and then I'll turn it over to Scott to talk about the that the Nash patient population.
So in terms of weight loss, we've always maintained that.
That is weight loss in mid teens would be competitive in our discussions we are finding it up that's basically where.
The University is in terms of at 48 weeks of Fiat in that mid teen range that would be a competitive weight loss, but once again I would like to emphasize that it's not just about weight loss. There are multiple parameters here that are going to play a role.
We believe that having this combination of GOP, London, and glucagon brings a unique aspect of unique attribute to the product, but the product will be much routes suited for obese patients.
<unk> tightened the fat content, and Dyslipidemia and Thats, a distinct patient population from <unk>.
Having diabetes and obesity, so I think as the steel develops there would be multiple segments in fact.
A number of patients with Dyslipidemia and obesity is higher than patients with diabetes and obesity. So we think there's significant opportunity there with mid teen net loss, but having the benefit of liver direct impact on liver.
And liver fat reduction.
Scott Harris do you want to address the second part of the question.
Sure.
Hey, guys, so regarding the biopsy procedure.
<unk> benefited greatly from the experience of other companies.
Really comparing across the readout methodologies. So we think we have a really robust plan in place based on that experience. We have not made those results public but.
<unk> not made that procedure public at this time, so I can't guide you any further on that but I would say that.
The plan will be quite robust and will.
Really decrease.
<unk> and variability that has occurred in the past and biopsy readouts.
Regarding the NIH is we've also benefited from the past experience as well.
And the screen failure rates can be brought down with the appropriate use of noninvasive tests and also other factors and we will screen patients on those noninvasive tests, such as fiber scan Asti and other co morbidities.
Being present in order to get the screen failure rate down to the lowest level possible.
Okay.
Thank you and I'll jump back into the queue.
Thank you one moment for our next question.
Okay.
Our next question comes from the line of Korean Jenkins from Goldman Sachs.
Yes, good morning, everyone.
Two questions from US first I noticed in the press release, you highlighted some portion of patients having higher levels of weight loss I am curious if there are any defining future features that correspond to these better responses at the high end of the range.
Scott do you want to close up.
Corinne.
I am not aware that within the press release, we highlighted specific patient types that we're in.
You said there was like 15%.
Something like 20% of patients achieve better than 15% of patients I am curious if there was anything in common across patients at the higher end.
Not.
Not that I can communicate at this point, we're continuing to look at that data.
As you know the marketplace is going to be very differentiated in the future.
They're going to be specific drugs that target specific patient subtypes and we're eagerly.
Pursuing that right now, but I can't give you any further information about the better responders in this trough.
Okay, and then just as you.
<unk> designed the Nash study I'm curious if you can share anything regarding powering assumptions that underpin.
On the design and what you expect to see in terms of either Nash resolution or fibrosis improvement.
These are what we call dual endpoints I want to emphasize our co primary endpoints.
The trial will be successful if either Nash resolution or fibrosis improvement is met.
And we.
At the sample size I provided which compares the one eight milligram dose to the placebo with 76 patients in each group.
Adequate power to achieve statistical significance on both of those endpoints.
Okay.
Thank you one moment for our next question.
Okay.
Our next question comes from the line of Roger song from Jefferies.
Great.
Or.
For the update and taking my question a couple of far less so the first one is regarding the dosing regimen.
<unk> not testing 2.4.
The Nash trial, so just curious why not yet.
$22 nine moving forward, particularly with that maybe longer penetration.
Competitors.
And second one is I think youll recall, the 20 core topline data 24 week top line data for Nash and <unk> 25 is that possible you will have our entire look like youre momentum trial have a portion of the patients reaching 2012 week for your <unk>.
The data readout maybe.
Maybe just that coincide with the.
With your partner discussion together with the LPT lockup.
I'll ask the question, maybe just follow up on that.
Question do you have any expectation for.
Our phase <unk> Nash resolution and fibrosis improvement.
In this marketplace compared to your.
Competitors. Thank you.
Well thanks for the question.
Yes sure.
Thanks for the questions Roger let me address them and if I don't address them completely because there were three questions in there get back to me and I will respond.
Regarding the two four milligram dose not being moved forward in Nash that's based on the fact that we achieved the efficacy needed at the one eight milligram dose and there does not appear Nash.
Pacifically the defining of the liver to move past the one eight milligram dose in this greatly simplifies the way the trial is.
As designed.
Regarding the use of the two four milligram dose in obesity.
We believe that.
Dose reduction itself, which has been employed in all of the other trials in obesity, but not employed and momentum will be adequate to address the issue of the higher discontinuation rates that we're seeing that the two four milligram dose.
The adverse event discontinuation rate in that trial was very similar to the adverse event discontinuation rates and the semi glu tied into his appetite trials at the same sort of phase of development.
And we believe that that employing that dose reduction for obesity will be very very good and we don't anticipate the need to titrate for a longer period of time, but this at this juncture.
Regarding the.
Your second question on the Nash trial at this point in time, we are not anticipating an interim look at the data it's something that we could consider but it's not in the current plan. The current plan is to read up the full trial in the first quarter of 2025, if that changes, we'll certainly make make that public.
Finally <unk>.
Regarding the expectations on the two endpoints.
I would point out that.
It's been clear that the greater reduction in liver fat that's achieved.
And as importantly, the rapidity of which it has achieved and we get rapid reductions in liver fat.
Translates to improvement of both of those endpoints. So we're very optimistic.
That we can achieve the same if not better results on both of those endpoints.
As other drugs in Nash development, and then on top of that.
Actually get effective weight loss, the highest weight loss thats been seen.
In the recent announced trials was two 6% and we believe that we can achieve much greater than that in the Nash trial. What that means is not only will patients have the benefit of the liver fat reduction and the improvement of Nash activity in the liver, though at the same time get a meaning.
Reduction in body weight that will make us.
Will differentiate us from the other drugs.
In development.
Excellent. Thank you Scott.
I appreciate it.
Yes.
Thank you one moment for our next question.
Our next question comes from the line of <unk> <unk> from Evercore ISI.
Hi, there how are you guys doing.
Can you hear me, yes, yes, sorry.
Okay.
Okay great.
I was just curious.
If you could maybe qualify or kind of.
The kind of.
Discussions you are having along the lines of partnering the obesity program.
What's the feedback from potential partners on the data you have so far if you could just kind of give us a sense of.
Is it is the view a little different than maybe the street's reaction are actually disqualify that some loyalty Christine.
Yes, Lisa. Thank you for the question all I can say that we have discussions ongoing.
Our goal is to have a partnership in place.
Our phase III development of this program.
Really cannot provide any more granularity than that and that at this point, but we'll we'll provide more information.
Tangible information becomes available.
Okay, and then just for the hepatitis D program, it's not one we've paid a lot of attention to.
So much focus has been on.
They obesity Nash program could you maybe talk about.
A little bit more about exactly what you're looking for in the study I know, obviously demonstration of anti viral effect, but if you could get into a little more detail like what.
Are you looking for change in <unk>.
<unk> HBV DNA RNA, how are you looking at it what kind of level of change would warrant further investment.
Yes, absolutely Scott Harris, and Scott Roberts, you guys want to handle that together.
Yes, so thanks for the question Lisa so.
That is a trial of Hep T cell monotherapy.
In patients with chronic with inactive chronic hepatitis b, which actually comprises the majority of patients worldwide and in the U S who have hepatitis b.
And Thats all.
<unk> is designed to show a meaningful change in the hepatitis b surface antigen and the primary endpoint of that study is either a one log reduction or clearance.
We are specifically in that trial chosen patients with low levels of the surface antigen. Because studies have shown that these are individuals who are starting to regain their immunologic response.
Against the hepatitis B virus.
So.
<unk>.
This would be a population that might respond to monotherapy. In addition to the hepatitis B surface antigen response, we'll look at other markers such as hepatitis B.
And also a pre genomic RNA and Theres some other markers in there as well so we'll have a global assessment of the response.
Now the ultimate vision is to combine <unk> T. So with the direct acting agents that are now in development that can take patients with active not inactive but active hepatitis b.
Many of whom have been treated with nucleoside and bring them down to that low level range, where there could be responsiveness to an immuno therapeutic like hepatitis b.
Those compounds in some cases are bringing the hepatitis b antigen down to on detectable levels, but it's not very common and what's very clear is when you stop the therapy the virus rebalance and clearance of the hepatitis B surface antigen, which is the ultimate goal is not achieved.
So it is envisioned by combining <unk> T. So with an antiviral that brings the hepatitis b surface antigen down to the range that I mentioned before in these active patients and then combined in combination with <unk> T. So could lead to permanent elimination of the virus, which would be what we call.
Where the surface antigen, which is what we call functional cure. So we envision a modest the potential for monotherapy and that inactive population, but also combination therapy with direct antivirals in patients who are active covering both aspects both population.
Since hepatitis B, both the large inactive population as well as the active population currently treated with nucleoside. So the commercial opportunity here is huge.
And the unmet need is just as large and we're really excited to see the top line results.
Okay and can you just remind us of the.
Mechanism of action.
Phil.
Yes, Lisa <unk>.
It's a combination of nine.
Long peptides and those peptides.
Represent highly conserved.
T cell epitopes, and so actually what we're doing is stimulating T cells to recognize.
The hepatitis B virus.
<unk> that are represented represent about 20% of the protium of the HBV.
So it's used with an adjuvant, it's IC 31, and by stimulating these T cells, which are want to respond to the HBV infection, but having a difficult time doing it we kind of give them a boost to be able to do that.
Some of the differentiating factors.
That the.
T cell epitopes that we are out representing an hefty cell are within regions that do not appear to undergo much drift or change.
In response to the virus.
Evolution and so these are because they are structurally and hydrophobic areas the virus needs to maintain visa can't really change them and so what we have is that as <unk>.
And approach that.
Was able to work against all of the genotype that we've looked at so far and.
So not directed against any particular genotype or subgroup of them, but we seem to have a very broad activity. So.
It's really a way to kind of energize. These T cells that get them over this activation barrier that they're experiencing in chronically infected state and.
Be able to respond to the infection that way.
Okay. Thanks.
Thank you one moment for our next question.
Okay.
Our next question comes from the line of my Yang Mom Tommy from B Riley.
Good morning team, thanks for taking our questions.
The target then videos of one eight Meg in the phase two b momentum steady.
Discontinuation was that I think 10% in the first 160 patients I was curious is there any reason for that rate to be different at the 48 week readout when you'll have the <unk>.
<unk> cohort of 320 subjects.
And maybe at a higher level. If you if you are able to comment on.
Some of the learnings you've had this week, we've had two glucagon DLP one.
Agents report on non type two diabetes obesity data.
Sweet.
I don't know.
Early to reflect on that from.
From you on a prudential partner, but I'd be very interested to add.
Perception of.
<unk> positioning in the broader landscape and then I just have a quick follow up.
As Scott Harris.
Sure.
<unk>.
So.
As you know the discontinuation rate that you spoke to was reported in the first 160 subjects.
So.
The results at the 48 weeks will includes all 320.
And also the.
The rate was based on a smaller number of subjects were.
One subject.
Would translate to approximately a 3% adverse event discontinuation rates. So that number is going to change and I wouldn't anticipate that it's going to.
No be no worse than perhaps even drop but again, we're going to have to look at the data.
It was a higher rate than we saw international D trials.
Again.
Pointing out the fact that it's a low discontinuation rate and in the future in future trials applying dose reduction would bring that down even further.
Regarding your second question about the Readouts this week.
<unk> readout I believe should approximately 14, 9% weight loss at 48 weeks.
The company did not report on a number of other things that would be of interest.
Didn't report the placebo response rates for example, so we couldnt look at the placebo adjusted rate.
They didn't talk about adverse events, specifically adverse event discontinuation they.
They didn't talk about heart rate increases that they had actually spoke to at a previous meeting. So we're going to have to wait until the full data is.
Reported.
At the Ada meeting in June .
Okay.
Great.
Just a quick follow up.
Given your comments on partnership.
Is it fair to say that.
Regulatory interactions from here on out end of phase II meeting.
Are you going to be done now by our future partner in.
In the Meanwhile, I was just curious if you intend to pursue any.
Other mechanisms Makefast side right to based on the quality of data you've generated specifically in Nash.
If you could comment on that that'd be great. Thanks for taking my question.
Yes in terms of the regulatory interactions, let me take that first and then Scott can talk about.
<unk>.
Nash data and how to use that going forward.
Our goal is to be phase III ready in the first half of 2024, so as the 48 week data becomes available at the end of the year. We are preparing for it out end of phase II meeting. So nothing really has changed on that on that plan that has always been our plan.
Even have additional interactions with the FDA might be might have a type C meeting did not.
Waiting for that but at the very least will have an end of phase II meeting once we have the 48 week data on obesity, but also have regulatory interactions with the FDA with regards to Nash as the <unk>.
<unk> phase III program here, we want to engage with them.
In order to discuss that.
The plans for using Biomarkers for Phase III studies, and what would be dead expectations and trying to align our program to that so there's a lot of regulatory interactions that will take place between now and the middle of next year.
Nothing really changes.
That because we think that's very important to have kept that in place to partner Mike haven't.
Some influence at the end.
During these meetings with the partner that is already on board. After the meeting so we'll certainly take that into account but.
Our plan is not to slow down that process.
Scott do you want to talk about just the second part of the question.
Yes sure.
So as Vipin mentioned.
We are planning.
Two with regards to Nash to speak to the.
Division of Herpetology.
Sometime in the near future I think it would be good to touch base with them about our plans for phase III and as Phil mentioned get advice regarding the development program fast track status is certainly a possibility.
We're looking into right now and something that we could definitely consider but I think the important thing is on Nash to engage them.
To get their feedback were extremely interested in the potential of using noninvasive marker in phase III and getting their feedback specifically on that and the trial design.
We've provided.
And.
In addition, as Vipin mentioned, we are planning.
End of Phase II meeting with the FDA.
Current plan is also to meet with them.
In advance in a type C meeting.
But that could be subject to change we will have to see.
But I think it's really important to have engagement with the agency and to get the agreement going forward in our development plans for both obesity and Nash.
And Scott.
We also we also plan to engage in.
Because again moving into phase III programs for obesity, that's going to be important so even even interactions with the EMA will also becomes.
We will also be occurring between now and the middle of next year.
And this is thanks for taking my questions.
Thank you one moment for our next question.
Our next question comes from the line of Jonathan <unk> from JMP.
Hey, good morning, Thanks for taking the question a couple for me.
Scott I believe you mentioned that youre going to be certifying impact for diabetes status and I know, we've seen weight loss differential between diabetic and non diabetic, but can you remind us the difference between liver fat IOP response rates in the phase one be between diabetic and non diabetic.
Yes. Thanks for the question Jonathan there were very similar.
So we don't anticipate that.
The amount or ratio of diabetics to non diabetics that it will be enrolled will materially impact.
Impact those results.
And I guess, then why are there infrastructure occasion.
Well, because mainly on the safety side.
Diabetics and non diabetics glucose control for example.
There is differences in adverse event rates. So it mainly on the safety side, rather than the efficacy side.
Got it that's helpful.
And the ZIP and you mentioned.
That potential partners are going to want to see the 48 week momentum data, which makes sense, but.
Can you talk a lot about the.
Utility of <unk> in Nash. So do you think that partners will also want to see the 24 week biopsy data from impact before settling into a partnership orange obesity driving the shift can you give us a little bit of sense about how <unk> plays into the partnering discussions.
Yes, I would say that.
It's really.
So much data already in mass in terms of.
Liver fat reduction and other inflammatory.
Biomarkers.
This story kind of makes sense.
We have a very compelling Stoney Nash combined with obesity. So we think we have enough we'll have enough information by the time, we have 48 week data and even there. Some partners may want to wait for 48 week data from maybe willing to to enter into a partnership ahead of that so we just have to see.
What kind of value, we have able to gap before the 48 week data will have to evaluate that at that time, but so.
So as you can imagine that various scenarios here that are that are placed on partners potentially more than that in obesity indications followed by mass in some cases, they may be more interested in Nash and obesity. The upside. So we have to play both sides of the uptake equation hidden and figure out what makes.
<unk>.
Yes.
Got it alright, thanks again for taking the questions.
Thank you one moment for our next question.
Okay.
Our next question comes from the line of Patrick <unk> from H C Wainwright and company.
Okay.
Good morning, just I am wondering if you can talk about the level.
<unk>.
The momentum interim data specifically among the key opinion leaders and trial investigators.
And how you envision would impact enrollment and the impact program potentially your future phase III program in obesity, and then separately just to follow up on Nash given that Theres. These multiple modes of action and broader impact on lipids and additional weight loss, how should we think about positioning on <unk> side relative to these other nash compounds and <unk>.
Approval of a new compound Nash our compounds potentially impact enrollment of your program.
Scott do you want to take that.
Yes, Patrick I apologize, but you broke up in the initial question and Im not sure I captured again captured accurately could you just repeat the first question about <unk> and the obesity trial sure.
Yeah, just just wondering about the level of enthusiasm.
<unk> following the announcement of the momentum interim data and really specifically among the key opinion leaders and trial investigators and how this may impact enrollment of the impact program or the future phase III program in obesity.
Well the enthusiasm has been very very high.
I mean <unk> is the principal investigator.
We've spoken a call on it has been speaking.
Publicly has been quite bullish and enthusiastic about the results.
And we think that the.
Hi.
Adverse event discontinuation rates at the two four milligram dose were readily explained.
And again, it's not a safety issue it is a.
Our ability issue.
And it's the same tolerability issue that other programs have had.
So it's something we feel confident that we can address.
The address head on both not only in terms of the study results, but also with investigators and I think they are partners in that and they've been happy with the impact.
On the trial.
And in the future program and regards to Nash.
We're seeing very very good lipid effects, we're seeing in LDL reduction.
The momentum program of approximately 12% and cholesterol, 15% or higher and consequently, these are definitely differentiating.
Other trials enrolling obviously has an impact but we have a.
Great group of investigators led by.
I considered the premier investigator in Nash that's Dr. Stephen Harrison.
Has a very strong network of investigators. He himself is extremely enthusiastic about this compound I think he would say.
This is one of the most promising drugs if not the most promising drugs in Nash development, not only because of its weight loss, which differentiates it from other compounds, but the level of liver fat reduction is class leading.
And consequently, there is a lot of enthusiasm among the investigators to enroll in this trial I think we have a really solid plan for bringing patients into the trial and the timeline that we discussed earlier in the call.
Yes.
And then Victor.
Yes.
Yes go ahead sorry.
Sorry, I was just going to say one follow up on T cell if I may.
Just.
I appreciate the insight there I am wondering if there is a preferred antiviral mechanism that.
That you would prefer to combined with tuck T cell based on the mechanism or if there are.
Antivirals out there that you've seen that are reducing S. Antigen by such an amount that you think you could sequence have T cell following treatment with that particular antiviral.
Yes, Patrick I will answer that question so.
Of the mechanisms that are out there the small inhibitory Rnas in the oligonucleotides have had the greatest benefit to reduce the surface antigen in clinical trials to date less so with the camps.
Capsid Assembly modulators, so although we're not excluding the cash at this time I think that probably the preferred mechanism would be there would be the small inhibitory Rnas or the oligonucleotides, but you know companies have data.
They may not have announced and consequently, we are entertaining all.
Approaches at this point in time.
I think the monoclonal antibodies that are directed against surface antigen seem to be working extremely well in that regard also and I think that those would certainly be viable candidates for combination. So as Scott says, it's an evolving field I think those are the types.
Type of agents that are easily identifiable now make a lot of sense that we're looking at but as the field evolves, obviously, we'll be keeping a close eye on and talking to partners about about.
Combination studies.
Yes.
That's helpful. Thank you so much.
Thank you at this time I would now like to turn the conference back over to Vipin Garg for closing remark.
Okay.
Okay.
Yes.
Thank you everyone for participating today and we appreciate this opportunity to share our results and outlook with you.
Thank you for your continued interests have a nice day.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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Okay.
Okay.
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