Altimmune, Inc. Q1 FY2023 Earnings Call

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. 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 and 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 weight 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 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 against HBV and establish its role in combination therapy for the treatment of this important disease. We are excited about the progress of 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 at 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 a 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 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 1:2:2 randomization scheme with subjects stratified for fibrosis stage and the presence or absence of diabetes. Therefore, approximately 36 subjects are expected to receive pemvidutide 1.2 milligrams, 76 subjects will receive pemvidutide 1.8 milligrams, and 76 subjects will receive 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, for 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 discussions have commenced with the FDA regarding 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 available to subjects who experience gastrointestinal 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 Weill 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 four prior trials with pemvidutide but similar to the adverse event discontinuation rates in similar Phase 2 trials of other incretin-based agents. We believe that the gastrointestinal adverse discontinuation rate can be mitigated to low levels in future trials of 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 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 an effective therapy for chronic hepatitis B requires 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, compared to $15.1 million in the same period in 2022. Approximately $10.8 million of this total for the first quarter of 2023 were direct expenses for the conduct of our clinical programs, including $8.7 million in direct costs related to development activities for pemvidutide and $2.1 million in direct costs 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, and 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. 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 are large markets, and we believe will benefit from having a partner for both of these indications. Our goal is to have a partner for the Phase 3 initiation by the time we are ready to start Phase 3 for obesity. In parallel, we'll also discuss with partners joining forces regarding 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 effectively 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 NASH as well, we will explore all of those options and 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 goal 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 weight 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 timelines are continuing to shake out? And then I'll jump back in the queue. Thanks.

Yes. No, the timeline is looking good. We think we can get the 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 the trial should start here in the next few weeks or the next couple of months. Based on our analysis of the time it will take to enroll these subjects, we believe keeping the first quarter of 2025 would be reasonable.

Thank you.

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 outstanding NASH trial design. A few questions for you. I think the first one is along with what Seamus was asking, Mike. In regards to discussions with partners regarding the profile of pemvidutide, do you feel 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 they will be read in pairs? 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. 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 the mid-teens would be competitive. In our discussions, we're finding that's basically where the consensus is in terms of at 48 weeks; if we are in that mid-teen range, that would be a competitive weight loss. However, 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 GLP-1 and glucagon brings a unique aspect or attribute to the product where it will be much better suited for these patients with high liver fat content and dyslipidemia. 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 those with diabetes and obesity. So we think there's significant opportunity there with mid-teen weight loss, along with the benefit of direct impact on 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 have greatly benefited from the experience of other companies, particularly in comparing across readout methodologies. We believe we have a robust plan in place based on that experience. We have not made those results public, so I can't guide you any further on that. However, I would say that the plan will be quite robust and will really decrease the variability that has occurred in the past in biopsy readouts. Regarding the non-invasive tests, we have also learned from past experience, and we can bring the screen fail rates down with the appropriate use of non-invasive tests and other factors. We will screen patients using non-invasive tests such as FibroScan, AST, and other comorbidities 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, do you want to take that?

Corinne, I'm not aware that within the press release, we highlighted specific patient types that were in the high response rate category. However, we are continuing to analyze that data. As you know, the marketplace is going to be very differentiated in the future, and 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 study.

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 NASH resolution or fibrosis improvement?

Right. These are what we call dual endpoints. I want to emphasize there are co-primary endpoints, so the trial will be successful if either NASH resolution or fibrosis improvement is met. At the sample size I provided, which compares the 1.8-milligram dose to the placebo with 76 patients in each group, we have 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 2.4 moving forward, particularly with maybe longer titration like your competitors? And second one is, since you will report the 24 top line data for NASH in Q1 2025, is it possible you will have an interim look like your MOMENTUM trial have a portion of the patients reaching 24 weeks before your Q1 2025 data readout maybe just coincide with your timeline 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. Let me address them, and if I don't address them completely because there were three questions there, feel free to follow up after. 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. It does not appear that the 2.4 milligram dose will define liver fat in this context, 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 in MOMENTUM, will be adequate to address the issue of 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. We believe that applying dose reduction for obesity will be very effective. We don't anticipate the need to titrate for a longer period of time at this juncture. Regarding your second question about the NASH trial, at this point, we are not anticipating an interim look at that data. It's something we could consider, but it's not part of the current plan. The plan is to read out the full trial in the first quarter of 2025. If there are changes, we will certainly make that public. Finally, regarding expectations on the two endpoints, I would point out that it's clear that a greater reduction in liver fat achieved, along with the rapidity of that reduction, translates to improvement in both of those endpoints. We're very optimistic that we can achieve the same, if not better, results on both of those endpoints compared to other drugs in NASH development. Moreover, we believe we can achieve effective weight loss. The highest weight loss seen in recently announced trials was around 2.6%, and we believe that we can achieve much greater than that in the NASH trial. This translates to a significant benefit with liver fat reduction and improved NASH activity, along with a meaningful reduction in body weight, which will differentiate us from 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?

Yes. Yes. We are doing fine.

Hi Liisa.

Doing well, Liisa.

Okay, great. I was just curious if you could maybe qualify 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 whether the view is 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 ongoing discussions 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 details become 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. This trial involves HepTcell monotherapy in patients with chronic hepatitis B, which comprises the majority of patients worldwide and in the US who have hepatitis B. That trial is designed to show a meaningful change in the hepatitis B surface antigen, with the primary endpoint being either a one log reduction or clearance. We specifically in that trial chose patients with low levels of the surface antigen because studies have shown that these individuals are starting to regain the immunologic response against the hepatitis B virus. This population may 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 some other markers as well. We'll have a global assessment of the response. The ultimate vision is to combine HepTcell with direct-acting agents that are now in development that can take patients with active hepatitis B to a low-level range where there could be responsiveness to an immunotherapeutic like hepatitis B. Those compounds have been shown to bring hepatitis B antigen down to undetectable levels, but it's not very common. What's clear is that when therapy stops, the virus rebounds, and achieving a clearance of the hepatitis B surface antigen is the ultimate goal. The envisioned potential for monotherapy in that inactive population, but also combination therapy with direct antivirals in patients who are active, covering both populations in hepatitis B, represents a huge commercial opportunity and addresses a significant unmet need. 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 consists of nine long peptides. These peptides represent highly conserved T-cell epitopes. We stimulate T-cells to recognize hepatitis B virus. The antigens represented account for about 20% of the genome of HBV. Using an adjuvant that's IC31, we provide a boost to the T-cells that need to respond to the HBV infection. Some differentiating factors are that the T-cell epitopes represented in HepTcell are in regions that do not appear to undergo much drift or change in response to virus evolution. They are structurally in hydrophobic areas allowing the virus to maintain these. Thus, we have an approach that can work against all genotypes we've looked at so far, and it's not directed against any particular genotype or subgroup of them, showing a very broad activity. This is a way to energize these T-cells and help them overcome the activation barrier they experience in chronic infection, enabling a response.

Okay. Thanks.

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 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? 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. The discontinuation rate that you spoke to was reported in the first 160 subjects. Therefore, the results at 48 weeks will include all 320. 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 will change. I anticipate there will be no worse and perhaps even drop, but we will need to look at the data. It was a higher rate than we saw in our NAFLD trials; however, I want to point out that it's a low discontinuation rate. In future trials, supplying dose reduction would bring that down even further. Regarding your second question about the readouts this week, the Boingo readout reported approximately 14.9% weight loss at 48 weeks. However, they did not report several important metrics, such as placebo response rates, so we couldn't analyze the placebo-adjusted rate. They also didn't mention specific adverse events, particularly adverse event discontinuations, or heart rate increases noted in a previous meeting. We will 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 to go into actions from here on out, like the end of Phase 3 meeting, all seemed to be done now by a future partner. 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 NASH 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. Nothing has really changed on that plan. That has always been our plan. We might even have additional interactions with the FDA; however, we could 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 data from obesity, and we will also have regulatory interactions with the FDA concerning NASH as we start our Phase II program here. We want to engage with them to discuss the plans for using biomarkers for Phase 3 studies and what their expectations would be in that regard. 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. We are indeed planning to speak to the Division of Hepatology regarding NASH sometime in the near future. We aim to establish communication with them about our plans for Phase 3 and, as Vipin mentioned, gain their advice regarding the development program. Fast Track status is certainly a possibility that we're currently looking into and something we could consider. However, it's essential to have engagement with the agency to receive their feedback. We are extremely interested in the potential of using non-invasive markers in Phase 3 and will seek their feedback specifically on that issue. As Vipin mentioned, we are also planning an end of Phase II meeting with the FDA. We also plan to meet with them in advance in a Type C meeting, subject to change. However, engaging with the agency is crucial to align our development plans for both obesity and NASH going forward.

Got it. We also plan to engage in Europe because, again, moving into a Phase III program for obesity will be important. Interactions with the EMA will occur between now and the middle of next year.

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. I know we've seen weight loss differential between diabetics and non-diabetics. But can you remind us of the difference between liver fat ALT response rates in the Phase 1b between diabetics and non-diabetics?

Yes. Thanks for the question, Jonathan. The response rates were very similar. Therefore, we don't anticipate that the ratio of diabetics to non-diabetics enrolled will materially impact those results.

And I guess, then why the recertification?

Well, mainly for the safety side, diabetics and non-diabetics exhibit differences in adverse event rates, particularly regarding glucose control, which is why we are stratifying on that basis.

Got it. That's helpful. And Vipin, you mentioned that potential partners are going to want to see MOMENTUM data, which makes sense. But you talk a lot about the utility of pemvidutide in NASH. Do you think that partners will also want to see the 24-week biopsy data from IMPACT before solidifying a partnership, or is obesity driving the shift? Can you give us a little bit of a sense about how NASH plays into the partnering discussions?

Yes. I'd say that we have a compelling narrative in NASH based on the existing data we possess concerning liver fat reduction and other inflammatory biomarkers. We believe we will have enough information by the time we achieve the 48-week data. However, some partners may prefer to wait for 48-week data, while others might be willing to enter into a partnership ahead of that. We will evaluate the value we can obtain before the 48-week data is shared. As you can imagine, there are various scenarios at play here. Some partners may be more interested in obesity indications followed by NASH, while others could prioritize NASH followed by obesity upside. So we must navigate both sides of this equation to determine the optimal approach.

Got it. 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 enthusiasm for pemvidutide following the announcement of the 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 are these multiple modes of action and broader impact on lipids and additional weight loss, how should we think about positioning pemvidutide relative to these other NASH compounds? And how could approval of a new compound in NASH potentially impact enrollment in your program?

Scott, do you want to take that?

Well, the enthusiasm has been extremely high. For instance, Louis Aronne, our principal investigator, has been publicly enthusiastic about the results of our findings. We believe that the high adverse event discontinuation rates at the 2.4 milligram dose were readily explained. It's not a safety issue but rather a tolerability issue. It's similar to tolerability issues experienced by other programs. We feel confident in addressing this issue in both our study results and with our investigators. There's a strong network of investigators involved, especially with Dr. Stephen Harrison, a premier investigator in NASH, who has been extremely enthusiastic regarding this compound. We are confident in having a solid plan for enrolling patients and adhering to the timelines we've discussed.

Yes, that's helpful. And then just one follow-up on HepTcell, if I may. 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. Of the mechanisms currently in development, small inhibitory RNAs and oligonucleotides have shown the most significant benefit in reducing the surface antigen clinically compared to CAMs, the Capsid Assembly Modulators. Although we are not excluding CAMs at this time, we believe the preferred mechanism would be small inhibitory RNAs or oligonucleotides. However, companies may have data they have not yet reported, which we are considering for all approaches.

I think the monoclonal antibodies directed against surface antigen also seem to show excellent efficacy, which we regard as plausible candidates for combinations. As Scot mentioned, it's an evolving field, and we will keep a close eye on it, discussing potential combination studies with partners.

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.