Altimmune - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 results were in line-to-better on EPS but missed on revenue versus Street: EPS of ($0.21) beat consensus ($0.26) while revenue of $0.005M missed consensus $0.56M; Altimmune reaffirmed major near-term catalysts including the 48-week IMPACT readout and End-of-Phase-2 (EOP2) FDA meeting in Q4 2025. Values retrieved from S&P Global.*
• Operating execution strengthened: cash, cash equivalents and short-term investments rose to $210.8M, up ~60% YoY; R&D declined to $15.0M (timing of CRO costs), and net loss improved to ($19.0M) YoY.
• Regulatory and clinical narrative advanced: EOP2 meeting granted based on 24-week data; 48-week IMPACT readout will add longer-term NITs and weight loss; RECLAIM (AUD) completed enrollment early; RESTORE (ALD) enrollment ongoing.
• Balance sheet and financing flexibility increased via a Hercules debt amendment to $125M with a $20M draw and extended interest-only period, plus planned shelf and ATM facilities referenced on the call—key funding optionality ahead of Phase 3.

What Went Well and What Went Wrong

What Went Well

• “We are approaching a major inflection point for the pemvidutide MASH program… the 48-week data from the IMPACT trial is expected before year end” (CEO).
• EOP2 meeting granted on strength of 24-week biopsy and NIT results; flexibility to adapt Phase 3 endpoints to potential regulatory acceptance of NITs and AI reads (CMO/CEO).
• AUD program momentum: RECLAIM Phase 2 enrollment completed months ahead of schedule; Fast Track designation in AUD; topline expected 2026.

What Went Wrong

• Revenue miss: actual $0.005M vs consensus $0.56M (typical for pre-revenue biotech, but a formal miss). Values retrieved from S&P Global.*
• Fibrosis improvement at 24 weeks did not reach statistical significance in top-line (per earlier context), though robust NITs and AI fibrosis reductions support anti-fibrotic activity—necessitating longer duration/Phase 3 scale for a registrational endpoint.
• Continued net losses typical of clinical-stage development: Q3 net loss ($19.0M), though improved YoY; G&A rose due to fees and stock-based comp.

Transcript

Christophe Berthiaume (President and Chief Medical Officer)

In the ongoing regulatory conversation, the statistical significance achieved across a panel of NITs we are assessing in the IMPACT trial provides strong support for pemvidutide anti-fibrotic effects, which we will look to continue to assess in the upcoming 48-week readout. Speaking of the 48-week readout, we look forward to assessing the data and the potential of a longer treatment duration on NIT measurements, as well as further weight loss. Recall, we had early and significant MASH resolution in our 24-week biopsy data, and strong evidence of anti-fibrotic activity supported by the NIT analysis, along with the continuing weight loss and excellent tolerability. The emerging recognition that improvements in certain NITs are likely to translate to clinical improvement has led regulatory agencies to consider allowing the use of NIT data as a measure of efficacy in MASH clinical trials.

In clinical practice, MASH patients are often diagnosed and courses of treatment determined based on these non-invasive tests, and the possibility of the regulatory agencies more closely aligning with clinical practice bodes particularly well for pemvidutide given the strength of our NIT data. Dr. Mazen Noureddin, lead investigator on the IMPACT trial, will deliver a late-breaking oral presentation on the 24-week IMPACT results at the upcoming annual ASLD Liver Meeting. The acceptance of this abstract reinforces the significance of the data from the IMPACT trial and pemvidutide's opportunity in the broader MASH landscape. Our confidence in pemvidutide is underscored by the collective data surrounding the molecule from the seven trials completed to date. We are now preparing for a scheduled face-to-face end-of-phase two meeting with the FDA before year-end to review our proposed phase three MASH program.

The phase three trial will include the flexibility of using NITs and AI reads as an approvable endpoint in our registrational program if regulatory process moves in that direction. Beyond MASH, we believe that the balanced glucagon and GLP-1 agonism that is the hallmark of pemvidutide makes it a promising therapeutic candidate in both alcohol use disorder and alcohol-associated liver disease. In AUD, we have completed recruitment and randomization in the RECLAIM trial. That we were able to fully enroll this trial ahead of schedule is a strong indicator of the significant interest and major unmet need in this indication. We look forward to reporting results next year. Our ALD trial, RESTOR, was initiated in the third quarter, and enrollment is ongoing. Importantly, patients with ALD currently lack any approved therapies, and we believe pemvidutide's dual mechanism of action may make a difference for these patients.

We look forward to these results of these trials and further understanding the potential of Pemvidutide in the additional large patient population of unmet need. I am excited to be at Altimmune and to lead these programs forward. With that, I will turn the call to our Chief Commercial Officer, Linda Richardson, to discuss how we are preparing for phase three success in MASH. Linda.

Linda Richardson (Chief Commercial Officer)

Thanks, Christophe, and good morning, everyone. It's great to be here at Altimmune at this exciting time, and I echo Christophe's enthusiasm for joining this team and helping to shape the future of this significant therapeutic candidate. A quick background on me: I've been involved in all facets of commercialization for over 30 years at organizations of all sizes. I have experience in MASH, rare hepatic diseases, cardiometabolic diseases, including diabetes and dyslipidemia, and addiction medicine. We have a great opportunity in front of us with pemvidutide in MASH, as well as AUD and ALD, and I look forward to helping prepare for potential commercialization in each of these areas of high unmet need. My decision to join Altimmune was driven by the opportunity to bring real therapeutic advances to patients and the providers that care for them. Pemvidutide has this potential. Why do I believe this?

With Pemvidutide, we have one therapy that provides two important mechanisms of action, delivering improvements on three critical elements of MASH management. The single therapy is clear. The two mechanisms of action, glucagon and GLP-1 agonism, in a balanced one-to-one ratio, provide both direct liver effects and metabolic improvements, resulting in three important benefits for patients: one, rapid MASH resolution in as soon as 24 weeks; two, anti-inflammatory and anti-fibrotic effects in the liver, as demonstrated in multiple NIT assessments; and three, quality weight loss, including lean muscle sparing effects. Additionally, Pemvidutide has demonstrated a potential best-in-class tolerability profile with low discontinuation rates in the IMPACT trial. This could be another differentiating feature compared with other MASH therapies. My enthusiasm aside, I would like to highlight some feedback from recent market research we did in Europe.

Healthcare professionals and a small group of payers were provided with a projected blinded product profile of Pemvidutide, along with other blinded profiles of current and future potential MASH therapies. First, 70%-80% of the physicians surveyed indicated a high or very high likelihood to prescribe Pemvidutide based on the blinded product profile in both F2 and F3 patients. Here are some representative qualitative comments from hepatologists on Pemvidutide's differentiating features. "It's quite impressive. The fibrosis and the weight loss seems to be a class leader, and the side effect profile is good." Another quote, "For overweight and obese patients, it would be my go-to substance, my first-line approach. More powerful than other dual agonists with strong fibrosis data. Lean mass preservation would be a meaningful differentiator, very important in MASH and chronic liver disease." This is very encouraging early feedback.

In particular, the significance of demonstrating lean muscle mass preservation is potentially very differentiating. There is a growing interest in the prevalence and effects of sarcopenia in patients with MASLD. A 2024 meta-analysis found that sarcopenia was associated not only with progression but also correlated with MASLD-associated mortality. Other publications project that the prevalence of sarcopenia may be as high as one in four patients. Initial payer feedback was also encouraging. Payers provided us with a positive reimbursement outlook across the EU, with broad coverage expected given payers' positive perception of the Pemvidutide value proposition. We will continue to identify aspects of Pemvidutide therapy that may be important to payers, particularly as more therapies enter the MASH field. Patient and prescriber receptivity is critical, but reimbursement and access are equally important elements of a successful product launch.

I've had the opportunity to work closely with our clinical team to incorporate specific endpoints that we believe will be important drivers of market uptake and support a successful launch following potential regulatory approval. It's an optimal time to ensure that commercial considerations are designed into the phase three MASH program to accentuate the differentiators of Pemvidutide from current approved therapies and those to come. Alongside MASH, the AUD and ALD programs are very exciting and could expand substantially the addressable market for Pemvidutide. The rapid recruitment of our AUD trial that we discussed earlier is evidence of interest in this space and the patient need for new therapeutic options as well. In closing, I'm very excited to be here at Altimmune at such a crucial time. I look forward to continuing to update all of you on our commercial vision, plans, and expectations for Pemvidutide.

I'll now turn it over to Greg to review our financial results for the third quarter.

Thank you, Linda. And hello. Beginning with our balance sheet of September 30, total cash was $211 million, representing an increase of 60% over our cash position at the start of the year. We've made measurable strides as we sourced capital through a combination of available options, having raised $127 million. Through the first nine months of the year, building the cash position required to support our key development milestones. Another step we've taken to add to our financial flexibility was to amend our Hercules debt agreement, where we increased the overall facility size to $125 million and funded $20 million on executing that amendment today. The amendment improves several of the key terms, extending the interest-only period, for example. You'll see that we're filing a $400 million shelf registration today, along with a new $200 million ATM facility.

Consider these filings as part of our ongoing effort to assure the financial tools are in place to meet our needs going forward. Our cash position continued to strengthen through Q3 and into Q4. I'm happy with the trajectory and confident in the ability to build the balance sheet required to meet our development needs and position Pemvidutide for success. Now to comment on the Q3 and year-to-date financial results. R&D expenses were $15 million for the three months ended September 30, 2025, compared to $19.8 million in the same period of 2024. The three-month variance in R&D spend was related to the timing of CRO development costs year-over-year. The Q3 2025 spend included $9.2 million of direct costs related to Pemvidutide development, including roughly $3.7 million for the IMPACT phase 2b trial, $3.4 million for AUD and ALD startup costs, and $1.3 million for CMC.

G&A expenses were $5.9 million and $5 million for the quarter ended September 30, 2025, and 2024, respectively. This increase was driven by professional fees and non-cash stock-based compensation. To note, the total non-cash stock-based comp was $3.6 million in Q3 and $11.1 million year-to-date. No surprises there. Net loss for the third quarter of 2025 was $19 million or $0.21 a share compared to $22.8 million or $0.32 per share in the third quarter of last year. In summary, we are well-positioned in terms of our financial footing. With that, I'll turn the call back to Vipin for some closing remarks.

Dr. Vipin Garg (CEO)

Thank you, Greg. As highlighted today, we look forward to sharing the 48-week IMPACT data in Q4 and to discussing our progression into phase three clinical development at our end-of-phase two meeting with the FDA. As always, we thank you for your continued support and look forward to sharing further details of our progress. This concludes our formal remarks, and we would now like to take questions. Operator.

Operator (participant)

Thank you. We will now begin the question-and-answer session. To ask a question, please press star and one on your touchstone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two. At this time, we will momentarily wait to assemble our roster. We have the first question on the line of Roger Song from Jefferies. Please go ahead.

Roger S. (Senior Equity Research Analyst)

Hey, morning. Thank you for taking the question and congrats for all the progress. Maybe a couple of questions. First is on the upcoming 48-week data from the phase two, the IMPACT, MASH. How much of the data will inform your conversation with the FDA and then also the phase three design? What's the current thinking about the phase three in terms of the 24 versus the 48-week endpoint time point and the MIT and AI biopsy-driven, AI-based biopsy endpoint? Thank you.

Dr. Vipin Garg (CEO)

Yeah. Good morning, Roger. Thank you for the question. As far as the end-of-phase two meeting with the FDA is concerned, as you know, the end-of-phase two meeting was requested on the basis of the 24-week data. There would not be any 48-week data that would be part of that discussion at this point. Obviously, we will submit 48-week data when that's available. We believe, and apparently the FDA agrees with us, that we have sufficient data at 24-week to request. Now FDA has granted a meeting to us on the basis of that data. I think we're in good shape. Christophe, did you want to add anything to that?

Christophe Berthiaume (President and Chief Medical Officer)

No, I think that's correct. The 24-week data were strong enough to grant the submissions and grant the meeting. We are in good shape with those discussions by the end of the year.

Dr. Vipin Garg (CEO)

About the 48-week data, I think Roger, did you want to repeat your question, please?

Roger S. (Senior Equity Research Analyst)

Yeah, sure. Just the 48-week data, what's the current thinking about the phase three design based on the 48-week data?

Greg Weaver (CFO)

The 48-week data, we expect to continue confirming what we've seen in the 24-week data and the strength of this with the added weight loss. Hopefully as well on the NITs. We are in discussions. We will be discussing with the FDA this current regulatory environment with the potential change from those biopsy readings to the NITs. We will have more clarity when we meet at the end of phase two meeting.

Dr. Vipin Garg (CEO)

Yeah. Now, our goal, Roger, is to design a very flexible trial phase three program so we can take advantage of any of the changes that take place whenever they take place. We will go in with a very comprehensive, flexible design in terms of the phase three program. Should changes take place over the course of next months and year, we can certainly incorporate them and pivot to those and appropriately change our endpoints when that happens.

Roger S. (Senior Equity Research Analyst)

Excellent. Thank you.

Operator (participant)

Thank you. We have the next question from the line of Yasmin Rahimi from Piper Sandler. Please go ahead.

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

Hi, good morning, team. Thank you so much for all the great updates and congrats on the RECLAIM enrollment completion. I guess the first question is, based on sort of discussion with the key opinion leaders in this space. Do you have any idea in, I guess, the probability of the different scenarios of potentially using NITs or AI-based histological reading? If you could just maybe help us understand, based on the three scenarios, which one they think has a high probability of being able to get a sign-off. That's question one. Question two is, help us understand, I guess, the advantages of using AI-based biopsy reading versus traditional histology reading, especially when it comes to phase three studies and if any other sponsors have implemented that. The third question is, on RECLAIM, maybe help us conceptualize what would be considered a clinically meaningful endpoint in.

The primary endpoint there. I'll jump back in the queue.

Greg Weaver (CFO)

All right. I will start with the needs. The needs, there are a lot of different discussions ongoing at this point in time. We're aware that some of these discussions will occur with the ASLD Liver Meeting coming up at the end of this week, and we will learn more around that. We know the FDA is looking through this very closely. From our understanding, there is an increasing interest to look at those needs. As Vipin shared, we're designing our phase three in order to really have the flexibility to adapt to any changes on the regulatory landscape. On the AI, there are differences. The histopathologists, in general, look at the narrow part of the slides and estimate the level of fibrosis based on the number of criteria. That introduces quite a large amount of variability. The AI, on the other.

Aspect looks at the total area of fibrosis and does not quantify the stages only, but allows just a gradual and more comprehensive evaluation of the slides. This is something that allows for rapid evaluations with less variability. We know that this has been already approved by the EMA as an approach to look at the biopsies. The last, the third point was, I am not sure I fully heard the questions on the primary endpoint. Did you? I will have a second.

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

Yeah. You could.

Dr. Vipin Garg (CEO)

The RECLAIM trial.

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

That's right.

Greg Weaver (CFO)

Yeah. The RECLAIM trial, so the primary endpoint of the RECLAIM trial is the number of heavy drinking days that we are going to be looking at. And those change from baseline.

Dr. Vipin Garg (CEO)

Yeah. It's the number of heavy drinking days per week. That's the.

Greg Weaver (CFO)

Per week. Correct.

Dr. Vipin Garg (CEO)

Endpoint that we'll be looking at. Yasmin, we're really excited about the fact that this trial enrolled almost five months earlier than we were expecting. It really shows the critical unmet need out there and the fact that physicians and patients really like the drug. We're really excited about that.

Operator (participant)

Do you have any follow-up questions?

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

Thank you. I'm good.

Operator (participant)

Thank you. We have the next question on the line of Patrick Trocio from HC Wainwright & Co. Please go ahead.

Patrick R. Trucchio (Senior Research Analyst)

Thanks. Good morning. At 24 weeks, you reported statistically significant anti-fibrotic activity across multiple NITs. I am wondering what magnitude of change at 48 weeks would reinforce this confidence in fibrosis improvement as a key phase three endpoint. Separately, I think you have referenced expectation of continued weight loss through 48 weeks. What level of incremental loss or lean mass preservation would confirm Pemvidutide quality weight loss advantage and support differentiation?

Greg Weaver (CFO)

Yes, at 24 weeks, we saw very strong data on our fibrosis. We continued to see the weight loss that was not plateauing. As you know, some of the NITs can evolve at different times of the improvement for each of those patients. We continue to believe, based on this, that we will see added improvements in the patients on the study at 48 weeks after our 24 weeks. We will see which one we expect, for example, maybe liver stiffness to be something that should be improved. We will have those data very soon. We are really excited about this. Again, with what we have seen on the 24-week, that bodes well for what hopefully we should see on the 48-week.

Dr. Vipin Garg (CEO)

Yeah. The weight loss, as you said, Patrick, we expect to continue to have additional weight loss, just like we saw with our MOMENTUM trial. Just to remind everybody, this was not even our best dose in terms of weight loss. It was 1.2 and 1.8. The 2.4 milligram, we get even higher weight loss. Clearly, there is plenty of runway there in terms of achieving additional weight loss as well. Just to clarify, as far as the NITs are concerned, they do not all move in tandem. Some of them move early, some move later. What we need to show at 48-week is continued maintenance of many of these NITs because we have already achieved such high levels and then additional improvement in some of them.

Scot Roberts (Executive VP, Pharmaceutical Development)

Yeah. Just to bring the weight—hi, this is Scott Roberts—just to bring the weight loss back home, recall that of the direct-acting MASH agents that work directly in the liver, for example, the FGF21s, the thyroid beta agonists, there is no weight loss associated with that. We are already ahead of the game with respect to direct-acting agents. Any additional weight loss and the shape of the curve with it not plateauing certainly bodes well for realizing more weight loss is really just icing on the cake.

Linda Richardson (Chief Commercial Officer)

Yeah. I think I'll touch on—this is Linda. Thanks for the question. I'll touch on a little bit this concept of lean muscle mass sparing. When you look at various agents and you look at the studies, most of this has been seen in weight loss studies. You look at pemvidutide and the MOMENTUM trial. We had really a study duration of 48 weeks where our lean loss ratio was about 22% compared to other agents that were in the 39%, 26%, 37% range across the board. This matches more closely what natural weight loss would look like if you were doing traditional diet and exercise. You're always going to see some impact on lean muscle, but this matches what you would see kind of in the routine weight loss field. When we look at that and we see our weight loss, building this.

Promise into studying in phase three further, what happens in a longer trial when we have our 52-week study data from a phase three? If we see continuing loss of weight but muscle mass preservation, this would be extremely interesting to the field. When we are looking at a forward-testing product profile, this is one of the advantages that we very well may have. When I talked about working closely with the team, putting in these markers and preparing to evaluate them fully in a phase three trial is exactly the kind of thing that I need to have that can resonate with payers and physicians and patients down the line. That is kind of bringing all of what we know about our product together and ensuring we have the best shot on goal in phase three.

Patrick R. Trucchio (Senior Research Analyst)

Great. Thank you so much.

Operator (participant)

Thank you. We have the next question from the line of John Wolleben from Citizens. Please go ahead.

Jon Wolleben (Managing Director)

Hey. Thanks for taking the question. I was hoping you could talk a little bit about alcohol use disorder and alcoholic liver disease as distinct opportunities. It just seems like there's going to be significant overlap in the advantages or disadvantages of running one program versus both.

Dr. Vipin Garg (CEO)

Yeah. That's a great question, Jonathan. I mean, that's the reason we decided to expand the program into AUD and ALD because we believe there is significant opportunity in both of those, and we could be sort of the front runner in terms of driving additional value proposition for Pemvidutide. It's not just MASH, AUD, and ALD. These are very similar product profiles that we are looking for in terms of having this dual mechanism of action working directly in the liver, as well as in the case of AUD, having reduction of cravings. Bringing these multiple features together is really important. AUD typically leads to ALD, so AUD and ALD go hand in hand. The idea here is that if we can show success in AUD, chances are we'll also be successful in ALD.

We've actually already shown the endpoint that we used in MASH, one of the NITs, is what would be the endpoint for ALD. We already have some idea that the drug is working on these endpoints. We are very excited about these additional, these that can be developed independent of MASH, beyond MASH.

Jon Wolleben (Managing Director)

Okay. Thank you, Vipin.

Operator (participant)

Thank you. We have the next question from the line of Annabel Samimi from Stifel. Please go ahead.

Annabel Samimy (Managing Director and Senior Analyst)

Hi. Thanks for taking my question. Just going back to the product profile and pricing and payer discussions, maybe for Linda. I mean, I understand the potential differentiation and how exciting that could be for MASH. I guess the landscape is shifting a little bit now. Obviously, with semaglutide possibly having MASH, some combinations that are in development or seeking development with FGF21s. I guess maybe you can talk about how you think about MASH pricing when we have some of these other alternatives that could potentially help on the liver side, but indirectly and longer term. I just want to think about that because some physicians are really starting to think about payer pushback and cost. How should we think about that?

Linda Richardson (Chief Commercial Officer)

Absolutely. Perfect question related to the payer landscape. Reimbursement is largely you're looking at what is the value proposition of the drug for. I would say, physicians, patients, and the payers. You want to have something that's actually doing what it says it's going to do. The value proposition is based on the data. When you test a product that has the activity that we do, we have in one drug two mechanisms of action that provide a host of benefits and excellent tolerability to date. You look at some of the carving off, what kind of quality weight loss, what are the lipid impacts, what are other things downstream that you're seeing. The total package of the value proposition leads into assessing what it's worth. Instead of someone having to take two drugs.

You have two sets of side effects, two copays, or wait for a development program to bring that together, or face tolerability issues that do not allow them to stay on. We see that with some of the GLP-1s currently. We see other good products downstream coming together with their combinations, but let's see what their tolerability profiles look like. Let's see not having this one-to-one ratio what they look like. The package of what you can get in a product and the early onset of action, I believe as this is going to become a very crowded marketplace, payers are not going to want to necessarily pay for something that takes 72 weeks to see if it is working. How long do they have to be on this? Is the tolerability there?

When you show the MASH resolution that we saw at 24 weeks, which was outstanding, and then you look at the evidence that we provided in anti-fibrotic activity via NITs at 24 weeks, we are pretty much pushing up on what everyone else can do. In one molecule with all these benefits. My plan will be to focus on what we bring to the table, communicating the value of early activity that you can monitor. You do not have to wait 72 weeks to see some sort of improvement. Look at that. Look at the total benefits, and then see where you fit in the spectrum of what the pricing brackets will be. You are bringing more than a generic. Even paying for a generic and another product that you might want to use together is still a different activity than having it all in one.

That is where the value proposition will come as we build additional data, as we have other data coming out in the phase three program that we currently do not even have access to in our 24-week data. My plan is to be positioned for the future and drive the very best deliverable assets that we can from this molecule.

Annabel Samimy (Managing Director and Senior Analyst)

Great. Thanks. That's great context. Just a couple more from me. Just going into ASLD, I know that raising awareness of Pemvi is very important. Can you just give us some color around how you're going to be doing that at the upcoming meeting and how you're going to raise awareness among KOLs? Just one other quick question. RECLAIM obviously enrolled very quickly. How is the ALD enrollment going?

Greg Weaver (CFO)

All right. On our presence at ASLD, we have a number of activities that we have planned, a lot of engagements with KOL, one-on-one discussions with all of them, with patients' advocacy group as well. We are going to be continuing. I want to remind you that we have also two presentations, one oral, one poster, that were accepted as late breaker and that will be there at this time. We also have a reception where we have a lot of our clinical investigators, principal investigators from our studies, and a lot of interest there where we are going to meet as well. We are going to have a large presence at ASLD with some very exciting data that will be presented through those late-breaking presentations.

Linda Richardson (Chief Commercial Officer)

I would just add that having been in the MASH space previously, I do know a lot of the folks who are working with us at Intercept and in hepatology and gastroenterology. I look forward to rekindling through some of the meetings that we've had set up, relationships with them, as well as seeing old friends in the patient advocacy group. We are well. The company may not have had as many contacts before, and Christophe and I being new to the organization, but we will leverage the ones and the investigators that we've been working with. I think really having the podium presentation close at late breaker is a great way to end that meeting for us.

Dr. Vipin Garg (CEO)

Yeah. We'll have a very large presence. We are really looking forward to it. It'll be very exciting to bring Pemvidutide out in the open.

Greg Weaver (CFO)

Regarding the ALD enrollment, we are moving forward as planned. We're happy where we are right now with this enrollment. Obviously, the AUD was even more exciting by getting this study enrolled much earlier, which does not happen too often, but is a testament to what the team can do and the interest in this area from patients and physicians. We are excited, and we continue to move forward as we anticipated.

Annabel Samimy (Managing Director and Senior Analyst)

Okay. Great. Thank you.

Greg Weaver (CFO)

Thanks, Annabel.

Operator (participant)

Thank you. We have the next question from the line of Matt Montini from B. Riley Securities. Please go ahead.

Matt Montini (Equity Research Analyst)

Hi. Thanks for taking our questions. This is William from Mayank. Congratulations on a very nice quarter. Looking forward to seeing the upcoming Hazel presentation. Two for us. In terms of your phase two 24-week biopsy results, I was curious if you could talk to any new or incremental analysis that you may have performed that we may yet. Specifically, do you know if there's, by any chance, any F2 or F3 analysis that you did on the study? In regards to F4 patients, by chance, upon sort of re-evaluation of the biopsies, were any included in the study? How the data from your F3 patients might inform how PEMVI may perform in the F4 population? I have a follow-up.

Greg Weaver (CFO)

Yep. No, we continue to analyze our data. There's a large amount of information we can gather that will help us drive some of the phase three. With regard to those different stages, I want to remind you the design included only phase two and, sorry, only F2 and F3 patients. There were no F4 patients. We did some postdoc exploratory analysis. The sample size is small because the study was designed with a small number of patients. I'm cautious there, but we are very encouraged by what we're seeing. In particular, with these F2, F3 patients. We continue to have supportive data to move into the phase three in this population and look forward to the design of this and discussing this with the FDA.

Got it. In terms of Reclaim, as it's been said, it's obviously enrolled pretty far ahead of plan. I was curious if there's been any type of baseline analysis that's been compiled. If so, could you touch on how those baseline characteristics may compare to the original plan? Also, how does that inform your interest in your RESTOR ALD trial, where you're also looking at these liver-specific endpoints such as VCT and ELF? Maybe, what's the broader data package that you're looking for to collect that would help qualify as phase three enabling?

With regard to the RECLAIM data, we just finished the enrollment. We haven't done the baseline analysis at this point in time of all this information. Obviously, AUD and ALD are kind of a continuum with the patients in AUD being less severe than the patients in ALD. There is a clear unmet need in this population. We are looking at the evolution in both the most severe and the less severe populations. We're going to be looking at different parameters. Clearly, we just mentioned the days of heavy drinking, but as well liver parameters. We know that those populations have fatty livers and increased liver stiffness. We're going to be looking at this as our primary endpoint for ALD. That's where we are at this point in time. Again, we hear a lot of enthusiasm around this area.

Linda Richardson (Chief Commercial Officer)

I think the timing of this, just with the interest in no alcohol drinks, mocktails, dry January, every week there's something coming out on alcohol use. Here again, we have a product that is designed to help on two fronts. You can look at the glucagon direct-acting liver effects. I'm thinking if somebody's drinking that much that they want to cut back, they probably have done a little damage, just may not know it, but they're thinking about their drinking. Then you look at what you would get with the GLP-1 side, which may be helping with cravings. Again, it is one product bringing together two activities that do more benefit for patients with a tolerability profile. This is really the way we're looking at how can this drug best infiltrate indications that make the most sense, whether it's MASH, whether it's AUD, ALD.

You look for where are your strengths and play to your strengths.

Greg Weaver (CFO)

Got it. Very helpful. Appreciate the answers. I'll hop back into Q. Thanks.

Matt Montini (Equity Research Analyst)

Thank you.

Operator (participant)

Thank you. We have the next question from the line of Michael DeFor from Evercore ISI. Please go ahead.

Michael DiFiore (Director and Equity Research Analyst)

Hi, guys. Thanks so much for taking my questions. I have three. The first one, since you said that Europe has approved AI biopsy reads and that you intend to propose the PATH AI platform to the FDA later this quarter, what are the practical next steps once the clearance comes? For example, are your imaging and workflow systems already validated for PATH AI, or would there be a ramp-up period before you could implement the AI reads in phase three? I have two follow-ups. Thank you.

Greg Weaver (CFO)

Yeah. The way that the AI works is they digitize the slides. As long as they have good slides, and we've learned how to do that. That was part of our phase 2b study. We have excellent specimens and how to handle those. As long as they have good specimens to work with, they have their own proprietary digitalization technique. It would be a seamless introduction of that technology into the readout.

Michael DiFiore (Director and Equity Research Analyst)

Okay. Thank you. Relatedly, how will NIT tracking actually be implemented operationally in phase three in terms of frequency, imaging cadence, data interpretation? Any color you could offer on that?

Greg Weaver (CFO)

We're going to, I mean, there's different visits over the 52 weeks, with clearly imaging happening on quarters and six months, week 24 and week 48. There will be continuing examinations towards clinical outcome for the patients. The NITs, it's much more, much easier to do this more frequently. We have different schedules that can be even on the monthly basis, especially early on, where we can look at some of the blood-based NITs and get this information very early. We'll get some very nice reads on how those NITs are moving rapidly in the treatment algorithm here.

Michael DiFiore (Director and Equity Research Analyst)

Got it. And my final question is in regards to Lilly's Retatrutide. I know it's very early, and a lot needs to happen between now and then. But any thoughts on PEMVI's competitive positioning? Should PEMVI and Retatrutide compete against each other in the MASH space? Thank you.

Dr. Vipin Garg (CEO)

Yeah. As you know, Mike, Retatrutide is a triple agonist. Really, the benefit here is the same as with dual agonist. We believe the one-to-one ratio is more important here because we're balancing both GLP-1 and glucagon activity in the same molecule. We're getting full benefit. Glucagon is working directly in the liver, whereas GLP-1 is working indirectly through metabolic effects through weight loss. Really, adding GIP on top of that is not relevant for the MASH space. It may be more relevant for the obesity field. We think we are very well positioned versus the Retatrutide in the MASH as well as AUD and ALD space.

Michael DiFiore (Director and Equity Research Analyst)

That's very helpful.

Greg Weaver (CFO)

We know and we'll have some new data at ASLD Liver Meeting around the anti-inflammatory aspects on the liver level, which is also really important. We're excited to have really that. One-to-one ratio is really important for the direct activity on the liver.

Michael DiFiore (Director and Equity Research Analyst)

Excellent. Thanks again.

Operator (participant)

Thank you. We have the next question from the line of Kelsey Luzerne from William Blair. Please go ahead.

Kelsey Elizabeth Lucerne (Equity Research Analyst)

Hi. This is Kelsey Luzerne on for Andy. We had a question around the preclinical development program for the oral formulation of Pemvidutide. Just curious if you could share next steps and timelines for advancing this candidate. Any sort of thoughts around positioning relative to the injectable? Will it also be progressing in MASH as an alternative to the injectable form? And who you might see as your competitors for this program? Thanks.

Greg Weaver (CFO)

Sure. Happy to take that question. Recall that our last earnings call, I expressed a lot of excitement and enthusiasm for what was characterized appropriately as a breakthrough in our oral formulation program. We are continuing to push that forward. Obviously, next steps have to do with an IND and a clinical trial. The timing of that will be more clear as time progresses here. As far as how it fits into the landscape, I think there are two important features here that should be appreciated. The first is, unlike an oral pill, a small molecule, this is still Pemvidutide. It is unaltered. Once it enters the bloodstream following the oral administration, it acts just like Pemvi. We get the long half-life. We get the excellent tolerability profile that we have seen so far. We have the best of both worlds.

We have the specificity and potency of the peptide that is Pemvidutide as opposed to a small molecule. Yet we have the oral formulation. We are really excited about that potential. We think that as it stacks up against the others, which the vast majority, as you know, are small molecules, we have a real advantage there. We are excited about the program. We have made, as I mentioned last time, real headway. We are continuing to progress that. We will share more data as appropriate.

Kelsey Elizabeth Lucerne (Equity Research Analyst)

Thanks so much.

Operator (participant)

Thank you. Ladies and gentlemen, this concludes our question-and-answer session. I will now hand over the conference to Dr. Garg for closing comments.

Dr. Vipin Garg (CEO)

Thank you, everyone, again, for joining us. The coming weeks will be incredibly exciting. We look forward to sharing updates on the 48-week data and the end of phase two meeting with the FDA and hope to see some of you at ASLD. Thank you.

Operator (participant)

Thank you. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.