Altimmune, Inc. (ALT) Q1 2023 Earnings Call Transcript
Good day, ladies and gentlemen, and welcome to the Altimmune, 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. [Operator Instructions] 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 Altimmune. Rich, you may begin.
Thank you, J.J., and good morning, everyone. Thank you for participating in Altimmune’s first quarter 2023 financial and business update conference call. Members of the Altimmune team joining me on the call today are Vipin Garg, our Chief Executive Officer; Scot Roberts, our Chief Scientific Officer; and Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question-and-answer session. A press release with our first quarter 2023 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 constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.
For a discussion of some of the risks and factors that could affect the company’s future results from operations, please 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 to reflect 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 Altimmune’s website.
With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune.
Thank you, Rich, 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, pemvidutide, a GLP-1/glucagon dual receptor agonist in development for both obesity and NASH.
Late last year, we announced compelling 24-week data from our trial in subjects with NAFLD, and we plan to initiate the IMPACT Phase IIb NASH trial midyear 2023. We believe that the effects of pemvidutide on liver fat are class leading. We also believe that pemvidutide is the only NASH candidate in development that combines robust reductions in both liver fats and body weight. This is extremely important because NASH patients suffer not only from the complications of liver disease, but also from the underlying problem of obesity, a principal driver of NASH. Scott Harris will provide more details on the impact of trials shortly.
With regards to obesity, we look forward to reporting top line 48-week weight loss data from our \Phase 2 MOMENTUM obesity trial in the fourth quarter of this year. The MOMENTUM interim results of 160 subjects reported earlier this year showed weight loss of 10.7% at the 2.4 milligram dose and 9.4% at the 1.8-milligram dose compared to 1% base loss in subjects receiving placebo after only 24 weeks. The robust reduction in body based together with the effect of pemvidutide on serum lipids and blood pressure suggests that pemvidutide has the potential to be an important treatment option for patients with obesity, especially individuals with NAFLD and dyslipidemia.
Finally, enrollment in the Phase 2 clinical trial of HepTcell in chronic hepatitis disease 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 of against HBV and established its role in combination therapy for the treatment of this important disease. We are excited about the progress pemvidutide and the upcoming results of these ongoing trials.
With that, I’ll now turn the call over to our Chief Medical Officer, Dr. Scott Harris to discuss our clinical plans. Scott?
Thank you, Vipin, and good morning, everyone. First, let me start by reviewing the clinical plans for our IMPACT Phase 2b NASH trial. This biopsy-driven NASH trial will be conducted at approximately 60 sites in the US with Dr. Stephen Harrison, Medical Director of Pinnacle Research; and Adcock 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, a liver fat content of at least 8% as measured by MRI-PDFF, and NAFLD activity score of at least four on a pretreatment biopsy and either F2 or F3 fibrosis. At least 50% of the subjects will be required to have F3 fibrosis.
Subjects both with and without diabetes will be enrolled. In our two earlier NAFLD trials, the 2.4 milligram dose did not materially improve liver fat reduction or CT1 response over the 1.8-milligram dose and the 2.4 milligram dose will not be evaluated in this trial. Subjects will consequently be treated with pemvidutide 1.2 milligrams, pemvidutide 1.8 milligrams or placebo. We are planning for approximately 190 subjects to be enrolled in the IMPACT trial in a 1 to 2 to 2 randomization scheme with subjects stratified for fibrosis stage in the presence or absence of diabetes. Therefore, approximately 36 subjects are expected to receive pemvidutide 1.2 milligrams. 76 subjects pemvidutide, 1.8 milligrams and 76 subjects, placebo. The primary endpoints of the NASH IMPACT trial will be dual endpoints of achieving either NASH resolution with no worsening of fibrosis or fibrosis improvement with no worsening of NASH, with the primary treatment comparison being the 1.8-milligram dose versus placebo.
Secondary endpoints will include weight loss, liver fat reduction by MRI-PDFF, cT1 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 adjudication leverages the experience of other recently completed NASH trials, which we anticipate may optimize the likelihood of pemvidutide achieving robust endpoint responses. A plan has been developed to correlate noninvasive tests with NASH resolution and fibrosis improvement biopsy endpoints and the commenced discussions with FDA about the use of these biomarkers as primary endpoints in Phase 3.
We remain on target for the trial to commence midyear and to report top line results in the first quarter of 2025. Dose reduction will be made available to subjects who experienced GI intolerance, though pemvidutide was well tolerated in our two previous trials in subjects with NAFLD.
Now let me talk about the Phase 2 MOMENTUM trial of pemvidutide in obesity. The trial was designed to enroll approximately 320 subjects without diabetes but with obesity or overweight with at least one comorbidity.
Dr. Louis Aronne from Wild Cornell Medical School, a leading authority in obesity and obesity clinical trials is serving as the principal investigator. Subjects were randomized 1:1:1:1 to 1.2 milligrams, 1.8 milligrams, 2.4 milligrams pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. A prespecified interim analysis was performed when 160 subjects completed 24 weeks of treatment.
Weight loss of 10.7% at the 2.4 milligram dose and 9.4% at the 1.8-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 2.4 and 1.8 milligram doses.
The adverse event discontinuation rate at the 2.4 milligram dose was higher than observed in our 4 prior trials with pemvidutide, but similar to the adverse event discontinue rates in similar Phase 2 trials of other incretin-based agents. We believe that the GI adverse discontinuation rate can be mitigated to low levels in future trials to pemvidutide through the use of dose reduction.
We look forward to our top line results from our 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 top line readout parameters will include adverse events, vital signs, serum lipids, glucose control and study discontinuations
Also, as we previously announced, we have completed the enrollment in our Phase 2 multicenter clinical trial of HepTcell in patients with chronic hepatitis B. Chronic hepatitis B continues to represent a serious unmet need in the US and worldwide and represents a significant commercial opportunity. The HepTcell 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 HepTcell monotherapy as measured by a reduction in HBsAg and other virological markers of infection.
We expect to announce the results of this trial in the first quarter of 2024 once all subjects complete the six-month treatment period. It is generally believed that in an effective therapy for chronic hepatitis B, we require both direct-acting antivirals and immunotherapy, and we believe that HepTcell could be combined with novel direct-acting antivirals in this treatment strategy.
I’ll now hand the call over to Rich Eisenstadt to give an update on our third quarter financial results. Rich?
Thank you, Scott, and good morning, again. For today’s call, I will be providing a brief update on Altimmune’s first quarter 2023 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today.
Altimmune 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 and compared to $15.1 million in the same period in 2022.
Approximately, $10.8 million of this total for the first quarter of 2023, where direct expenses for the conduct of our clinical programs, including $8.7 million in direct cost related to development activities for pemvidutide and $2.1 million in direct cost related to development activities for HepTcell.
General and administrative expenses were consistent period-over-period at $4.5 million and $4.4 million for 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 $20.1 million or $0.40 net loss per share compared to a net loss of $19.4 million or $0.44 net loss per share for the first quarter of 2022. We estimate that our existing cash funds us through the 24-week biopsy results from our IMPACT Phase 2b NASH trial expected in the first quarter of 2025.
Our financing also funds completion of the 48-week MOMENTUM trial and the HepTcell trial. Our current cash projection includes no funding for the initiation of a Phase 3 obesity campaign, which would only commence with a partner.
I will now turn it back over to Vipin for his closing remarks. Vipin?
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. [Operator Instructions] Our first question comes from the line of Seamus Fernandez from Guggenheim Securities.
Great. Thanks for the question. So Rich, in your remarks, you commented that full advancement into Phase 3 obesity would require a partner, can you just help us understand, how Vipin 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’re hoping to see in the broader clinical data set 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 move forward? Thanks.
Yes. Good morning, Seamus, thank you for the question. So as you know, both the NASH and obesity, they’re both large markets, and we believe will benefit from having a partner for both of these indications. So our goal is to have a partner for the Phase 3 initiation by the time we are ready to start Phase 3 for obesity. And in parallel, we’ll also discuss with partners 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 exert serve for both of these indications, we’ll need a partner. So we will explore a partnership across both of these assets.
If it turns out that initially the partnership is only centered around obesity with a downstream prospect of including mass as well. We will explore all of those options that multiple ways of doing these partnerships. Obviously, we have embarked on our Phase IIb plan for NASH, and that data will become available in due course. So all of those items will sort of play a role in terms of ultimately designing the optimal structure for a partnership around both of these indications.
With regards to the data, as you know, we’ve announced the 24-week data. And again, our board has been to engage in partnership discussions on the back of that data, clearly, partners will also be looking for the 48-week data or at least some partners would want to see the 48-week data. We expect to continue to show additional rate loss — and I think that would be very important as we go into partnership discussions later this year.
Great. And then just wanted to reconfirm the timing of the NASH 24-week results. I think previously, you had stated that you anticipate having those results sometime in the first half of 2025. Just wanted to see, as you’re getting closer to the initiation of the Phase 2, how those time lines are continuing to shake out? And then I’ll jump back in the queue. Thanks.
Yes. No, the time line is looking good. We think we can get that — those results in the first quarter of 2025, and that’s what we are guiding to at this point. So we feel very comfortable saying that that the trial should start here in the next few weeks or a few couple of months. And basically, based on our analysis of the time it will take to enroll these subjects and keep the first quarter of 2025 would be in a reasonable time line.
Thank you. One moment for our next question. Our next question comes from the line of Yasmeen Rahimi from Piper Sandler.
Good morning, team and thank you so much for all the details and also the really outstanding NASH trial design. Few questions for you. I think the first one is along with what Seamus was asking, Mike. In regards to discussions with partners in regards to the profile of pemvidutide, do you feeling for what type of weight loss do they want to or see as 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 in the study? Will you have two readers where will they be red in pairs. So have you sort of logistical details around the reading? And then the third question is, if you could just comment on what NITs are being utilized at baseline for screening the patients and creating a home would you use population? And I’ll jump back right into the queue. And thank you again for taking my questions.
Yes. Yes, yes. And thank you for the question. I’ll take the first part of your question, and then I’ll turn it over to Scott Harris to talk about the NASH patient population. So in terms of weight loss, we’ve always maintained that a weight loss in mid-teens would be competitive. And in our discussions, we’re finding that’s basically where the universe is in terms of at 48 weeks, if we are 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.
I mean, we believe that having this combination of GLP-1 and glucagon brings a unique aspect or a unique attribute to the product where the product will be much well suited, but these patients with the high liver fat content and dyslipidemia. And that’s a distinct patient population from people having diabetes and obesity. So I think as the steel develops, there will be multiple segments. In fact, the number of patients with dyslipidemia and obesity is higher than patients with the diabetes ops. So we think there’s significant opportunity there with mid-teen weight loss, but having the benefit of direct impact on liver and liver fat reduction Scott Harris, do you want to address the second part of the question.
Sure. Good morning, Yasmeen. So regarding the biopsy readout procedure, we benefited greatly from the experience of other companies and really comparing across the readout methodologies. So we think we have a really robust plan in place based on that experience. We’ve not made those results public, but 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 the invariability that has occurred in the past in biopsy readouts.
Regarding the NITs, we’ve also benefited from the past experience as well, and the screen fail rates can be brought down with the appropriate use of noninvasive tests and also other factors, and we’ll screen patients on those noninvasive tests such as fiber scan, AST and other comorbidities being present in order to get the screen failure rate down to the lowest level possible
Thank you. I now jump back into the queue.
Thank you. One moment for our next question. Our next question comes from the line of Corinne Jenkins from Goldman Sachs.
Yes. Good morning everyone. A couple of questions from us. First, I noticed in the press release, you highlighted some portion of patients having higher levels of weight loss I’m curious if there are any defining features that correspond to these better responses at the high end of the range?
Scott Harris, you want to take that.
Corinne, I’m not aware that within the press release, we highlighted specific patient types that were in the…
You said there was like 15% of something like 20% of patients achieve better than 15% of patients. I’m curious if there was anything in common across patients at a higher end sort of response.
Not that I could 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 and that there are 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 as you designed the NASH study, I’m curious if you can share anything regarding powering assumptions that underpin the design and what you expect to see in terms of either national solution or fibrosis improvement?
Right. These are what we call dual endpoints. I want to emphasize there or co-primary endpoints so the trial will be successful with either NASH resolution or fibrosis improvement is met. And we — at the sample size I provided, which compares the 1.8-milligram dose to the placebo with 76 patients in each group gives adequate power to achieve statistical significance on both of those endpoints.
Thank you. One moment for our next question. Our next question comes from the line of Roger Song from Jefferies.
Great. Thanks for the update and taking the question. A couple from us. So the first one is regarding the dosing regimen since you’re not testing in the NASH trial. So just curious when or if you will test 2.5 moving forward, particularly with maybe longer titration like your competitors? And second one is, since you will report the 24 top line date 24-week top line data for NASH in 1Q 2025. Is that possible you will have for interim look like your MOMENTUM trial have a portion of the patient reaching 24 weeks before your 1Q 2025 data readout maybe just coincide with your time discussion together with the BCT.
Last question, maybe to follow up on the previous question, do you have any expectation for your Phase 2b NASH resolution and fibrosis improvement in this marketplace compared to your competitors? Thank you.
Yeah. Thanks for the question.
I am asking to both? Yeah. Go ahead.
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 I get back to main. And I’ll respond.
Regarding the 2.4 milligram dose, not being moved forward in NASH, that’s based on the fact that we achieved the efficacy needed at the 1.8 milligram dose and it does not appear in NASH, specifically the defining of the liver to move fast the 1.8 milligram dose, and this greatly simplifies the way the trial is designed.
Regarding the use of the 2.4 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 in momentum will be adequate to address the issue of the higher discontinuation rates that we’re seeing at the 2.4 milligram dose.
The adverse event discontinuation rate in that trial was very similar to the adverse event discontinuation rates in the Semaglutide and Tirzepatide trials at the same phase of development. So — and we believe 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 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 that data. It’s something that we could consider, but it’s not in the current plan. The current plan is to read out the full trial in the first quarter of 2025 of that, changes will certainly make that public.
Finally, regarding the expectations on the two end-points, 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 is 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 that’s been seen in the recent announced trials was 2.6%, 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 meaningful reduction in body weight that will make us — will differentiate us from the other drugs in development.
Excellent. Thank you, Scott. You answered all the questions. I appreciate it.
Thank you. One moment for our next question. Our next question comes from the line of Liisa Bayko from Evercore ISI.
HI there. How are you guys doing? Can you hear me?
Yeah. Yeah. We are doing fine.
Doing well, Liisa.
Okay, great. I was just curious, if you could maybe qualify or kind of the kind of discussions you’re 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 the view a little different than maybe the Street’s reaction, or if you could clarify that some may that be interesting.
Yes, Liisa, thank you for the question. All I can say is that we have discussions ongoing and our goal is to have a partnership in place for Phase 3 development of this program. I really cannot provide any more granularity than that at this point, but we’ll provide more information as tangible information becomes available.
Okay. And then just for the hepatitis B program, it’s not one we’ve paid a lot of attention to, so much focus has been on the obesity NASH program. Could you maybe talk about a little bit more about exactly what you’re looking for in this study? I know obviously, demonstration of antiviral effect. But if you could get into a little bit more detail, like what — are you looking for change in 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, Vipin. So, thanks for the question, Liisa. 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 US who have hepatitis B.
And that trial 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 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 the immunologic response against the hepatitis B virus. So, 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 DNA and also pre-genomic RNA and there are some other markers in there as well. So, we’ll have a global assessment of the response.
Now, the ultimate vision is to combine hep T cell 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 immunotherapeutic like hepatitis B.
Those compounds, in some cases, are bringing the hepatitis B antigen down undetectable levels, but it’s not very common. And what’s very clear is when you stop the therapy, the virus rebounds and clearance of the hepatitis B surface antigen, which is the ultimate goal is not achieved.
So, it’s envisioned by combining hep T cell 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 hep T cell could lead to permanent elimination of the virus, which would be what we call — or the surface antigen, which is what we call functional cure.
So we envision the potential for monotherapy in that inactive population, but also combination therapy with direct antivirals in patients who are active, covering both aspects of — both populations in hepatitis B, both the large inactive population as well as the active population currently treated with nucleosides. 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 behind T-cell?
Yes, Liisa. So HepTcell is a combination of nine long peptides. And those peptides represent a highly conserved T-cell epitopes. And so actually, what we’re doing is stimulating T-cells to recognize the hepatitis B virus, the antigens that are represented, represent about 20% the prodium of the HBV. So it’s used with an adjuvant that’s IC31 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 are that the T-cell epitopes that we are representing in HepTcell 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 in the hydrophobic areas, the virus needs to maintain these. They can’t really change them.
And so, what we have is an approach that was able to work against all of the genotypes 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 and get them over this activation barrier that they’re experiencing in promically infected state and be able to respond to the infection on that way.
Thank you. One moment for our next question. Our next question comes from the line of Mayank Mamtani from B. Riley.
Good morning, team. Thanks for taking our question. So for the target the dose of 1.8 mg in the Phase 2b MOMENTUM study, where discontinuation was at, I think, 10% in the first 160 patients. I was curious, is there a reason for that rate to be different at the 48-week readout, when you’ll have the entire cohort of 320 subjects?
And maybe at a higher level, if you are able to comment on some of the learnings you’ve had this week, we’ve had two glucagon GLP-1 agents report on non-Type 2 diabetes obesity data this week. So I don’t know, if it’s too early to reflect on that from you or a potential partner, but I’d be very interested to hear your perception of BMV’s positioning in the broader landscape? And then I just have a quick follow-up.
Yes, Scott Harris?
Sure, Mayank. 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 include all 320. And also, the rate was based on a smaller number of subjects where one subject would translate to approximately a 3% adverse event discontinuation rate. So that number is going to change. And I would anticipate that it’s going to — they’ll be no worse and perhaps even drop. But again, we’re going to have to look at the data. It was a higher rate than we saw in our NAFLD trials — but again, pointing out the fact that it’s a low discontinuation rate and in the future in future trials, supplying dose reduction would bring that down even further.
Regarding your second question about the readouts this week, the Boingo [ph] readout, I believe, showed approximately 14.9% weight loss at 48 weeks. The company did not report on a number of other things that would be of interest. They didn’t report the placebo response rates, for example, so we couldn’t look at the placebo-adjusted rate — they didn’t talk about adverse events, specifically adverse event discontinuations. 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.
Great. And maybe just a quick follow-up. Given your comments on partnership, is it fair to say that you’re able going into actions from here on out, like the end of Phase 3 meeting is all seemed to be done now by a future partner. And in the meanwhile, I was just curious if you intend to pursue any other mechanisms like fast track at breakthrough based on the quality of data you’ve generated specifically in NASH. If you could comment on that, that would be great. Thanks for taking my question.
Yes, Mayank, in terms of the regulatory interactions, let me take that first, and then Scot can talk about just the mass data and how to use that going forward. Our goal is to be Phase 3 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 our end of Phase 2 meeting.
So nothing really has changed on that plan. That has always been our plan. We might even have additional interactions with the FDA, but we might have a Type C meeting. We are preparing for that. But at the very least, we’ll have an end of Phase II meeting once we have the 48-week paydown obesity, we’ll also have regulatory interactions with the FDA with regards to NASH as we start our Phase II program here, we want to engage with them in order to discuss the plans for using biomarkers for Phase 3 studies? And what would be their 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 and nothing really changes not that, because we think that’s very important to have that in place a partner might have some influence at the end, but either during these meetings, if the partner is already on board or after the meeting. So we’ll certainly take that into account. But our plan is not to slow down that process. Scot, do you want to talk about just the second part of the question.
Yeah. Sure, Mayank. So as Vipin mentioned, Mayank, we are planning to — with regards to NASH to speak to the Division of Hepatology sometime in the near future. I think it would be good to touch base with them about our plans for Phase 3. And as Vipin mentioned, get advice regarding the development program. Fast Track status is certainly a possibility that 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. We’re extremely interested in the potential of using noninvasive marker in Phase 3 and getting their feedback specifically on that. And the trial design that we’ve provided. And in addition, as Vipin mentioned, we are planning an end of Phase II meeting with the FDA. The current plan is also to meet with them in advance in a Type C meeting, but that could be subject to change. We’ll have to see. But I think it’s really important to have engagement with the agency and to get their agreement going forward in our development plans for both obesity and NASH.
A – Vipin Garg
Got it. And that we also — we also plan to engage in Europe because, again, moving into Phase III program for obesity that’s going to be important. So even interactions with EMA will also become will also be occurring between now and the middle of next year.
Q – Mayank Mamtani
Understood. Thanks for taking my questions.
Thank you. One moment for our next question. Our next question comes from the line of Jonathan Wolleben from JMP.
Hi, good morning. Thanks for taking my questions. A couple for me. Scott, I believe you mentioned that you’re going to be stratifying impact for diabetes status. And I know we’ve seen weight loss differential between diabetics and non-diabetics. But can you remind us the difference between liver fat ALT response rates in the Phase 1b between diabetics and non-diabetics.
A – Scott Harris
Yes. Thanks for the question, Jonathan. They were very similar. So we don’t anticipate that the amount or ratio of diabetics to non-diabetics that will be enrolled will materially impact those results.
And I guess, then why the recertification [ph]
A – Scott Harris
Well, because of mainly on the safety side, diabetics and non-diabetics. Glucose control, for example, there’s differences in adverse event rates. So mainly on the safety side rather than the efficacy side.
Got it. That’s helpful. And Vipin, you mentioned that potential partners are going to want to MOMENTUM data, which makes sense. But you talk a lot about the utility of PEMV and NASH. So do you think that partners will also want to see the 24-week biopsy data from IMPACT before selling into a partnership — or is obesity driving the shift? Can you give us a little bit of sense about how NASH plays in the partnering discussions?
A – Vipin Garg
Yes. I would say that it’s really — we have so much data already in NASH in terms of liver fat reduction and other inflammatory biomarkers that the story kind of makes sense that we have a very compelling story in NASH combined with obesity. So we think we have — 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, some may be willing to enter into a partnership ahead of that. So we just have to see what kind of value we are able to get before the 48-week data, we’ll have to evaluate that at that time. But — so as you can imagine, there are various scenarios here that are that are at-play. Some partners are potentially more interested in obesity indications followed by NASH. In some cases, they may be more in NASH, and then obesity upside. So we have to play both sides of the equation here and figure out what makes more sense.
Got it. All right. Thanks again for taking the questions.
Thank you. One moment for our next question. Our next question is from the line of Patrick Trucchio with H.C. Wainwright & Company.
Good morning. Just I’m wondering if you can talk about the level of the — pemvidutide — MOMENTUM interim data, specifically among the key opinion leaders and trial investigators, and how you envision this would impact enrollment — in the impact program potentially your future Phase 3 program in obesity.
And then separately, just a follow-up on NASH, given that there is these multiple modes of action, a broader impact on lipids and additional weight loss, how should we think about positioning in pemvidutide relative to these other NASH compounds? And how could approval of a new compound NASH or compound potentially impact enrollment of your program?
Scott, do you want to take that?
Yeah, Patrick, I apologize, but you broke up in the initial question, and I’m not sure I captured it again — captured it accurately. Could you just repeat the first question about pemvidutide and the obesity trial?
Sure. Yeah. Just wondering about the level of enthusiasm in pemvidutide 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 3 program in obesity?
Well, the enthusiasm has been very, very high. I mean Louis Aronne, who is a principal investigator, who spoke in our call and has been speaking publicly has been quite bullish and enthusiastic about the results, and we think that the high adverse event discontinuation rates at the 2.4 milligram dose were readily explained. And again, it’s not a safety issue. It’s a tolerability issue, and it’s the same tolerability issue that other programs have had.
So it’s something we feel confident that we can address head on, both not only in terms of the study results, but also with investigators, and I think they’re partners in that, and they’ve been happy with the impact on the trial in the future program.
And regards to NASH, we’re seeing very, very good lipid effects. We’re seeing an LDL reduction in 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 the — I consider the premier investigator in NASH, that’s Dr. Stephen Harrison. He has a very strong network of investigators. He himself is extremely enthusiastic about this compound. I think he would say that 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’s 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 meaning the time line that we discussed earlier in the call.
Yes, that’s helpful. And then just…
Yes. Go ahead, sorry.
Sorry, I was just going to say one follow-up on HepTcell, if I may. Just I appreciate the insights there. I’m wondering if there is a preferred antiviral mechanism that you would prefer to combine with HepTcell 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 HepTcell following treatment with that particular antiviral?
Yes, Patrick, I’ll answer that question. So of the mechanisms that are out there, the small inhibitory RNAs and the oligonucleotides have had the greatest benefit to reduce the surface antigen and clinical trials to date, less so with the CAMs, the Capsid Assembly Modulators. So although, we’re not excluding the CAMs at this time, I think that probably the preferred mechanism would either be the small inhibitory RNAs or the oligonucleotides. But companies have data that they may not have announced. And consequently, we’re 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 combinations. So as Scot says, it’s an evolving field. I think those are the types of agents that are easily identifiable now make a lot of sense that we’re looking at. But as a field evolves, obviously, we’ll be keeping a close eye on and talking to partners about combination studies.
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 remarks.
Thank you, everyone, for participating today. We appreciate this opportunity to share our results and outlook with you. Thank you for your continued interest. Have a nice day.
This concludes today’s conference call. Thank you for participating. You may now disconnect.