Good morning, ladies and gentlemen, and welcome to the Altimmune Second Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. A reminder, this call is being recorded. I'll now introduce your host for today's conference call, Lee Roth, President of Burns McClellan, Investor Relations Adviser to Altimmune. Lee, you may begin.

Thanks, Olivia. Good morning, everyone. Once again, thank you for joining us for the Altimmune second quarter 2025 financial results and business update conference call. On today's call, you'll hear from Doctor Vipin Garg, our Chief Executive Officer, Doctor Scott Harris, our Chief Medical Officer, and Greg Weaver, our Chief Financial Officer. Doctor Scott Roberts, our Chief Scientific Officer, and Ray Jordt, our Chief Business Officer, will join us for the Q&A. Our second quarter 2025 financial results and corporate update press release was issued earlier this morning and it can be found on the Investor Relations section of the Altimmune website. Before we begin, I'd like to remind everyone that remarks made about future expectations, plans, and prospects constitute forward-looking statements for purposes of the 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, and these could cause our actual results to differ materially from those indicated. For a full review of the risk factors that could affect the company's future results and operations, we refer you to the company's filings with the SEC. I also direct you to read the forward-looking statement disclaimer in our press release issued this morning, which is available on our website. Any statements made on this call speak only as of today's date, 08/12/2025, and the company does not undertake any obligation to update any forward-looking statements to reflect events or circumstances that occur on or after today's date. As a reminder, this call is being recorded and will be available for audio replay on the Altimmune website. With that, it's my pleasure to turn the call over to Doctor Vipin Garg, President and Chief Executive Officer of Altimmune. Vipin?

Thank you, Lee. Good morning, everyone, and thank you for joining us today for our second quarter financial results and corporate update. As many of you know, we presented the twenty-four-week top-line data from the IMPACT trial in June. As we shared, pembiguate achieved statistical significance in the primary endpoint of NASH resolution and across multiple objective measures of efficacy at twenty-four weeks of treatment. These included all noninvasive markers of inflammation and fibrosis, liver fat reduction, and weight loss, along with best-in-class safety and tolerability without the need for dose titration. These data will serve as the foundation of the package that we take to the FDA for our end-of-phase-two meeting in the fourth quarter and will inform the design of our Phase III program. In addition to the advancement of our NASH program, our Phase II trials in AUD and ALD, RECLAIM and RESTORE, are now underway. Alcohol use disorder and alcohol-associated liver diseases are two indications with significant unmet needs and few to no treatment options, for which we believe famidutide may be particularly well suited. As we announced yesterday, our board has appointed Jerry Durso as Chairman of the Board, succeeding Doctor Mitch Sayer, who has served in this role for the past seven years and will remain with us as a nonexecutive director. This change reflects our planned advancement to Phase III development of pembidutide in NASH. Jerry has a wealth of commercial and corporate development experience, including the building of a successful liver franchise as CEO of Intercept prior to its acquisition. We are excited to continue moving forward under Jerry's leadership and look forward to Mitch's ongoing contribution. With $183.1 million in cash and cash equivalent, we have considerably strengthened our balance sheet as we work to continue to advance the development of pembidutide and look forward to reaching additional milestones, including the full forty-eight-week impact data as the year progresses. With that, I'll now turn the call over to Doctor Scott Harris, our Chief Medical Officer, to provide a clinical development update. Scott?

Thank you, Vipin. Those of you on the call with us are likely familiar with the INPCT top-line data that we reported about six weeks ago. I'd like to expand upon a few of the key highlights of this positive and important dataset. First, we achieved MATCH resolution up to 59.1% of subjects, a highly statistically significant result after twenty-four weeks of treatment. On the other measure of fibrosis improvement, we did not reach statistical significance, but clear evidence of antifibrotic activity was observed that was supported by additional objective measures of fibrosis improvement. As Vipin noted, multiple measures of efficacy that were assessed at the twenty-four-week time point achieved statistical significance. We demonstrated impressive results in all of the noninvasive tests of liver fibrosis, including enhanced liver fibrosis and vibration control transient elastography. In addition, the pathway-based analysis of the biopsies showed a statistically significant improvement in liver fibrosis in a supplemental analysis. We recently completed our analysis of another important noninvasive test of fibro inflammation, corrected T1 imaging or CT1, where a class-leading effect for pemvedutide was observed at the twenty-four-week time point. CT1 is a reproducible MRI-based liver imaging method that has been correlated with changes in liver inflammation and fibrosis in clinical studies. Decreases in CT1 relaxation time of eighty milliseconds or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies. At twenty-four weeks, mean decreases from baseline and CT1 relaxation time were 145.0 and 147.9 milliseconds in the 1.2 and 1.8 milligram pemvigutide treatment arms, respectively, compared with a decrease of 27.5 milliseconds in placebo, representing a p-value of less than 0.001 for both doses. These new data add additional depth to the data demonstrating that strong anti-inflammatory and antifibrotic activity of pemvedutide treatment. In addition to these impressive effects…

Thanks, Scott. Beginning with the balance sheet. We finished the second quarter with total cash of $183.1 million. That's an increase of approximately 40% over our cash position at the start of this year. We've raised $88 million in gross equity capital this year, while adding the flexibility of a $100 million Hercules debt facility, which we announced in the second quarter, and drew down $15 million from that facility at signing. These strategic financial moves are part of our ongoing efforts to ensure that our balance sheet is able to support the continuing clinical development of PEMV. We are committed to staying focused on driving value as we work to position PEMV to benefit Match patients. Now to briefly comment on the Q2 financial results. First, R&D expenses, which were $17.2 million for the three months ended June 30, as compared to $21 million in the same period of 2024. And this amount includes $11.2 million of direct costs related to pembidutide development. Breaking that down further, approximately $5.5 million for the IMPACT Phase 2B trial, $2.6 million for AUD and ALD startup Phase two costs, and $1 million for our pempadutide oral formulation preclinical development. G&A expenses were consistent period over period at $5.7 million and $5.6 million for the quarters ended 06/30/25 and 24. Really nothing noteworthy to call out in our G&A. Net loss for 2025 was $22.1 million or $0.27 a share compared to a net loss of $24.6 million or $0.35 a share in the second quarter of the prior year. With that, I'll turn the call back to Vipin for closing remarks.

Thank you, Greg. 2025 will be an exciting period for Altimmune as we report the forty-eight-week impact data and prepare for our end-of-Phase II meeting, while continuing to enroll the Phase II trials in AUD and ARD. This concludes our formal remarks, and we would now like to open the line to take questions. Operator?

Thank you. Our first question coming from the line of Annabel Samimy with Stifel. Your line is now open.

Hi. This is Jayed on for Annabel. Thanks for taking our question. I have two. The first one related to the mass development plan. You've had some time to digest the data. And we did see VIBERSA improvement not reached that SIG, but to what extent could you still leverage the other improvements in this and the path AI analysis at week 24? How does the FDA view these new measures? And could you potentially get it into the label by including those endpoints in a phase three?

Hi, Jayed. This is Scott and thank you for the question. There's more and more emphasis being placed on noninvasive tests. And the overall feeling among experts in the areas that we will be moving to a noninvasive test or nit-based improvement at some point in the future. I think the FDA is warm to that. We actually haven't seen that happen at this point. I want to remind you that we achieved highly statistically significant effects on e. F. And VCTE, sometimes called FibroScan, which are considered the best noninvasive tests for assessing fibrosis. And also the PathAI I should remind you that PathAI analyses have been accepted in Europe as the basis of approval and that FDA is now reviewing that proposal and we should have some news on that in the near future. So we think that based on these highly recognized and validated measures of fibrosis improvement, that we not only have excellent evidence that fibrosis improvement is occurring, we're actually meeting what could be FDA and EMA expectations for approval in both of these areas. So as we've said before, there is a great deal of evidence that we have very potent antifibrotic effects. We're very confident about our ability to be able to hit these effects in Phase III.

Yeah, I just wanted to add that, just to remind everybody that this readout was at twenty-four weeks. At forty-eight weeks or beyond, which is where really the phase three program will be designed for, we believe that we will hit the statistical significance in the fibrosis endpoint. With longer trials and larger trials, that would reduce the placebo noise, that's really the reason we didn't hit the endpoint in this twenty-four-week study. So we feel very good about going into a Phase III program, in spite of whether the nits are allowed or not, even without that, we should hit the fibrosis endpoint in a longer Phase III trial.

Thank you. I had one more question. It's related to the AUALD trial. I could be wrong about this, but I do recall you guys mentioning that you would test different doses like 1.2, 1.8, 2.4 with titration. It looks like you're only testing the 2.4 milligrams in these trials. Is there a particular reason for that?

Yes. I mean, we think that for Phase two trial, it's appropriate to only test one dose. We were testing the most efficacious dose and then we'll have that conversation with FDA and other regulatory agencies going forward. And there's always the opportunity to expand that and to analyze different doses in a Phase three program. But we think that we're going in with what will be our most efficacious dose and then we can re-examine other doses as the program unfolds.

Great, thank you.

Thank you. And our next question coming from the line of Ellie Moore with UBS. Your line is now open.

Hey, this is Jasmine on for Ellie. Thank you for taking our question. So, on your end of Phase II meeting, can you talk about what you're hoping to discuss with the FDA and align with them on? Are you planning to discuss the possibility of an NIP-based Phase III design with them? And will we get an update after this meeting? Thank you.

Hey, Jasmine, thanks for the question. I think that we really can't provide a lot of details about the meeting and our proposals until we actually have the meeting and there'll be a lot of topics to discuss. Opinions of the FDA on this are shifting right now and we're keeping our ears very close to the ground on this. So we expect to be able to have a very rich conversation with the FDA along multiple lines of approaching this and have an update for you after the end of the Phase II meeting.

Okay, awesome. Thank you.

Thank you. And our next question coming from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.

Hi, this is Dominic on for Yasmeen Rahimi. Congrats on a great quarter and thank you for taking our question. So we just had a few questions. The first one, was there any measures on alcohol alcoholic consumption in the impact study that could derisk reclaim and restore? And then kind of going with that, what is the timing for those readouts? And what do you need to see to advance in the Phase three?

Right. So, are continuing to analyze the data sets from the IMPACT trial, and we'll have an update on any alcohol measures as we continue to provide data. As you know, we're continuing to analyze the results of the trial and we'll provide on that information as we further analyze the data. We think we have a great deal of evidence for the effects of pempadutide on AUD and ALD. As you're aware, we have a very impressive animal study showing that an 80% drop in alcohol consumption in animals who were given free choice, as well there's a huge literature on the effects of GLP-one agents in alcohol consumption, both observational trials and at least one randomized trial. And as you know, with ALD, the pathophysiologic basis of that is fat-induced liver inflammation very similar to NASH. So we feel very confident of our ability to hit the endpoints in both the AUD and ALD trial. And in terms of the Phase III development program in those indications, we'll meet with the FDA after the Phase II results and get agreement on what that program looks like.

Thank you.

Thank you. And our next question coming from the line of Roger Song with Jefferies. Your line is now open.

Great. Congrats on the progress and thank you for taking our question. Maybe just also on the end of phase meeting, how much more work you need to do before you cannot request the meeting? My understanding you have not requested the meeting. How much data from this forty-eight-week readout is needed to finalize the Phase III design proposal? And then I have a follow-up question. Thank you.

Yeah, Roger, we feel very good about having that meeting by the end of the year. And we'll have the results of that meeting and share it with The Street. Other companies have met with twenty-four weeks of data. And I want to remind you that we have a lot of information on forty-eight weeks of data and dosing from our obesity momentum study. So consequently, we feel confident that we'll have the data to go in and we'll have that meeting. We should have it sometime in the fourth quarter and we'll inform the Street on what the results of that

Got it, thank you. And then my follow-up question is, with the new chairman appointment, so how will the corporate strategy evolve regarding the partnership for phase three and commercialization? It seems you're more focused on the commercialization now. Thank you.

Yes, that's, as you can imagine, that's part of the natural evolution. The board is continuously evaluating the skill set at the Board level. Given that we're now moving into Phase III, the Board felt that addition of bringing Jerry as Chairman would be an added advantage for the, for the management team to, to move forward. So his experience in domain area in, in liver, building a liver disease company, and ultimately being part of that M and A transaction would be important as we move forward.

Thank you. Our next question coming from the line of Catherine O'Klakone with Citizens. Your line is now open.

Hi. This is Catherine on for John. I just have a quick question about the T1 responses and how the results from impact compared to other programs. I know that you said kind of best in class, but if you could kind of give us some kind of ranges from the other competitor programs. Thanks.

Yeah, Kathryn, so as you're aware, the results that we have were in the range of a reduction of about 145 to 140. That was seen in this trial, but it was also seen in a prior trial or Phase 1b trial in patients with fatty liver. And based on the public data, we're seeing readouts of approximately 50 to 60 for Resmitteram and up to about 107 for Tirzepatide. So you can see that these results that we're getting, 147 versus a range of 50 to 107, are clearly superior to other compounds, at least those that are reported in the public domain. And that given the association of CT1 with reduction of both, mesh activity and fibrosis that this is one other measure among many measures showing the potent anti-inflammatory and antifibrotic activity of the compound.

Great, thank you.

Thank you. Our next question coming from the line of Patrick Tuchio with H. C. Wainwright. Your line is now open.

Hi, good morning, and congrats on all the progress. I just have a couple of follow-up questions on expectations around the Phase III program then as well just maybe looking further ahead to potential commercialization and the product profile that's emerging. I guess the first part of the question is just around kind of updated thoughts on dosing strategy, 1.2 milligram, 1.8 milligram and then the higher dose and how you're thinking about the dose selection for the Phase three. And then as well, you know, primary endpoints, how are you thinking about primary endpoint, co-primary endpoint? You know, would mass resolution as primary with fibrosis improvement? Or would there be a co-primary design? And I guess, how would you power for both? And then just as it relates to just the commercial potential, just based on, I mean, there's a lot of data and I think there's a lot of points of differentiation here. So, if the Phase three were to reproduce the impact efficacy and tolerability, I guess, how do you see the positioning in NASH if there's an eventual approval?

Patrick, I'll take the first part of the question for the commercial potential. I'll turn it over to Vipin. So, as you are aware, we studied the 1.2 and the 1.8 milligram doses and impact. And even at the 1.8 milligram dose, which is not our most potent dose for weight loss, we still achieve 6.2% weight loss at only twenty-four weeks. And the trajectory of the weight loss indicated there was a lot more weight loss to be had. So we think it's going to be very attractive to put the 2.4 milligram dose into Phase three. Would not only give more weight loss to the extent that it could problem us even more provide even more efficacy, we find that very attractive. Regarding the other two doses, that's currently being looked at very critically and we'll discuss that with the agency and have an update for the Street after we have our end of Phase II meeting. As you're aware, there are two endpoints in NASH, NASH resolution and fibrosis improvement. In the IMPACT study, we had a dual endpoint, meaning that we either had a hit, MAH resolution or fibrosis improvement for the trial to be successful and consequently, IMPACT was a successful trial. We could go into Phase III with a similar strategy of dual endpoints. There's also the possibility of co-endpoints when you have to hit both, etcetera. And then in the background, you have endpoints based on noninvasive tests, which we feel are very exciting. And by the way, EMA has approved the use of a PathAI methodology for actually reading out mesh resolution and fibrosis improvement using computerized algorithms assisted by the pathologist but driven predominantly by the computer, which we think is going to reduce greatly the noise that we're seeing in the trial and probably help us control the placebo response and really express the antifibrotic potential of the compound. So we think there's a lot of things that play here in terms of the discussion with the FDA. It's going to be a very exciting and important end of Phase II meeting. And as soon as we have further information, we'll update the street. So with that, I'm going to turn the commercial discussion over to Vipin. Vipin?

Yeah, I just want to emphasize one other thing with regards to the FDA discussion. You know, one thing I want to remind everybody is that we have a very large safety database that we have already accumulated on pembidutide. So part of our discussion would be how do we leverage that? Do we think there is an opportunity to reduce the number of exposures in terms of the safety database. So we'll certainly be having that dialogue with the FDA, as Scott said, among many other things that we'll be discussing with the FDA. So looking forward to that. Patrick, in terms of commercial potential of pemigutide, as we have said all along and as you pointed out, there are multiple points of differentiation. First and foremost, we are combining two mechanisms: direct action in the liver, a direct acting agent in the liver with a metabolic agent with weight loss. So really think of it, we're treating NASH with obesity. And when you look at the NASH landscape, everybody's talking about the benefit of adding weight loss on top of liver-directed effect. We're bringing that in single molecule, we're combining these two mechanisms. So we're treating NASH, but on top of that people are losing weight. Sixty to eighty percent of patients with NASH are obese or overweight, so they would benefit from losing weight. So that's number one, which we believe is a very big advantage or differentiating factor for pembidutide. You know, in our, in our work, our market research, it's clear that physicians are looking for a drug where people will not only improve their liver health, but will also lose weight. Secondly, safety and tolerability is going to be very, very important. And as you can see from our data, we are seeing class-leading tolerability profile. We think that can be leveraged. Patients like that, doctors like that, lack of dose titration is going to be a major plus when we go, when we commercialize pembituride. So it's really the benefit of combining the two mechanisms, and on top of that, having a very clean safety and tolerability profile that we think is going to speak well in terms of the commercial success of the product.

Great. Thanks so much.

Thank you. Our next question coming from the line of Mayank Mamtani with B. Riley Securities. Your line is now open.

Hi. Thanks for taking our questions. This is William on for Mayank today. Two from us. Maybe I'll start with the first. So now that we know that Lilly has gotten positive FDA buy-in on pursuing high-risk MAZZOID trial for their Reta and Tirzepatide. They're using NITs for patient screening and then foregoing biopsies completely for primary efficacy endpoint. And it looks like even in the trial, looking more of an outcomes type trial. How do you see this as an opportunity for Pembina to execute on a capital-efficient Phase III trial? And is your understanding that this still only biopsies are a way to secure Subpart H accelerated approval?

And then I have a follow-up.

Well, thanks, William. Yeah, think it's really exciting. I think it creates a real opportunity for us in noninvasive tests and we're taking a very careful look at that. We think that there's real opportunity for us here and we'll certainly have that discussion with the FDA.

As we said, will look at every potential opportunity to come up with an innovative trial design and incorporate all of these things that are now becoming clear that the FDA is reviewing. So we'll certainly have all of those discussions. We can't get into the specifics right now, but we'll definitely talk about it once we've had the end of phase two meeting.

Yeah, let add to that, William, that there are a lot of exciting things happening here, the development of NITS, the movement toward AI-based reading in Europe and we think there's a good chance that FDA will pick that up and you saw that we had very positive results from the AI-based analyses that really reduce the noise from the manual pathologist readout. So there are other developments here that are going to increase our probabilities of success in Phase three. We're very interested in those and share your excitement and plan to have that discussion with the FDA this fourth quarter.

Got it. And then also, again, also sort of thinking of crosstown peer. Merck has their Afinopegutide readout coming out shortly, and they're looking at biopsy results at forty-eight weeks. Slightly different glucagon ratio here, but what could their data mean in terms of your forty-eight-week data potentially in Phase three or obviously your just your net data coming up at the end of the year? And what may you be specifically looking for to bring confidence phase three going forward and what will help guide you in the development of that phase three?

Right, well, as you noted, William, the reading added forty-eight weeks. And another glucagon compound is read out at forty-eight weeks, and these have lesser ratios of glucagon. As Vipin mentioned, we read out at only twenty-four weeks. So we think that our readouts at forty-eight weeks, had we done the biopsy week forty-eight weeks, would have been as good if not better than the other compounds. That's certainly supported by the very potent noninvasive test results we're seeing at week twenty-four. I want to remind you that there hasn't been an incretin, let alone a glucagon containing incretin that is read out at week twenty-four. And at week twenty-four, our MATCH resolution was comparable to or superior to other compounds at week twenty-four and better than compounds reading out at later time points in forty-eight to seventy-two weeks. So we think that afinipegatide readout will be further confirmation of the efficacy of the compound. Now, as you know, we don't have a biopsy at week forty-eight, but we have the noninvasive tests. And we expect to be able to use the noninvasive test to model and to predict what we would have seen a week of 48 had we done the week biopsy, forty-eight-week biopsy. So we think that data will be very supportive of our mechanism and our efficacy.

Got it. Thanks for that color. I'll hop back in the queue.

Thank you. Our next question coming from the line of Corinne Johnson with Goldman Sachs. Your line is now open.

Good morning. Maybe just one from us. How should we think about the cadence of research and development spend from here as these AUD and ALD studies kind of get up and further running and enrollment increases? Thanks.

Thanks, I appreciate the call. This is Greg and in terms of the R&D spend investment in AUD and ALD, these are phase two trials. They're baked into our budget for this year, they're incorporated in our cash runway. These are relatively modest in size, and we're on it. Don't anticipate anything unusual in our burn rate going forward in the near term as related to AUD ALD.

Okay, thanks.

Thank you. Our next question coming from the line of Andy Hsieh with William Blair. Your line is now open.

Thanks for taking the question. Just a quick one. Very interested in the oral program that you are advancing. So I'm curious, maybe from a technological perspective, we think about it as a gastric absorption enhancer. And also just curious if you can tell us a little bit more about how you would position this formulation in the grand scheme of things.

Thank you.

Yes. Thanks for the question.

We've been at this for a little while here and I'm excited to share that we've had a big breakthrough in the activity. From the very beginning, we focused on two elements that really differentiate an oral formulation of the peptide from others that are out there, Rybelsus for example. The first is to get away from the food restriction. You mentioned gastric absorption. That's exactly what we're trying to get away from.

And we've done that from the beginning and focused on that because when it's absorbed in the gut or in the stomach, then it's really about very tight food restrictions that you're aware of for the Rybelsus indication. So that's one of the things we wanted to do. And the secondary feature was to make sure that it really made sense from a cost of goods standpoint. As you know, the oral absorption is always inefficient compared to subcutaneous injection, but to make it work, we had a fairly high threshold for what we would be interested in. So I think that things are looking very good in that respect. I think this breakthrough that we had was mechanism-based that it went just the way we expect and we're looking forward to translating that into a preclinical development and nomination there. So as far as the impact on the commercial situation, I'll let Vipin speak to that.

Yes. I mean, our strategy with the oral program is very similar to what you would expect with what's being done with other products. Really a life cycle management question. As this field grows, there would be attractiveness to the oral program. As Scott mentioned, oral delivery is never going to be as efficient as subcutaneous injections. So we believe that both of these formulations would be important in terms of developing commercially the value proposition around pemidutide.

Wonderful, thank you.

Thank you. And there are no further questions in the queue at this time. I will now turn the call back over to Doctor Vipin Garg for any closing remarks.

Thank you all for joining our call today. As always, we appreciate your continued support and look forward to keeping you updated in the months ahead. Have a wonderful rest of the day.

This concludes today's conference call. Thank you for your participation, and you may now disconnect.