Altimmune (ALT) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 12, 2026

CALL PARTICIPANTS

• Chairman and Chief Executive Officer - Jerome Benedict Durso
• Chief Medical Officer - Christophe Arbet-Engels
• Chief Commercial Officer - Linda Richardson
• Chief Financial Officer - Gregory L. Weaver
• Vice President of Investor Relations - Luis Sanay

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TAKEAWAYS

• Cash and Investments -- $480 million as of Sept. 30, 2026, which management expects will provide an operating runway through the anticipated PERFORMA 52-week data readout in 2029.
• Net Loss -- $31.6 million, representing an increase from a net loss of $19.0 million in the prior-year period.
• Net Loss Per Share -- $0.15, compared to $0.21 in the third quarter of 2025, reflecting a significant increase in the weighted-average shares outstanding to 205.3 million.
• Research and Development Expenses -- $27.0 million, rising from $15.0 million year over year due to the initiation of the Phase 3 trial in MASH and the ongoing Phase 2 trial in ALD.
• Pemvidutide Direct Costs -- $20.3 million, consisting of $10.7 million for MASH, $4.3 million for AUD and ALD trials, and $5.4 million for manufacturing related expenses.
• General and Administrative Expenses -- $8.7 million, up from $5.9 million in the third quarter of 2025, driven by higher compensation and professional fees.
• Interest Income -- $4.8 million for the third quarter.
• U.S. Site Activation -- over 70 active clinical sites in the U.S. as part of a global program targeting approximately 300 total sites for the Phase 3 PERFORMA trial.
• Total Planned Sites -- 300 global clinical sites are scheduled for the PERFORMA program to support the anticipated 52-week data readout.
• Phase 2 ALD Enrollment -- 121 patients enrolled in the RESTORE trial, with top-line efficacy and safety results expected in the second half of 2027.
• AUD Market Opportunity -- 27 million Americans meet the criteria for AUD, with 12 million suffering from moderate to severe forms of the disorder.
• Pharmacotherapy Rate -- 2.2% to 2.5%, representing the percentage of patients meeting AUD criteria who currently receive medical drug therapy.
• Patient Exposure -- more than 750 patients have been exposed to pemvidutide across the company's clinical development programs to date.
• RECLAIM Clinical Efficacy -- achieved statistical significance in the primary endpoint of heavy drinking days and key secondary measures in the Phase 2 AUD study.
• Proposed Phase 3 Dosing -- 1.8 milligram and 2.4 milligram doses with a one to two step titration are planned for the registrational AUD program.
• FibroScan Measurement -- showed improvements of 3 to 4 kilopascals in the IMPACT study, illustrating the potential for direct liver benefit.

SUMMARY

Altimmune, Inc. (NASDAQ:ALT) reported a net loss for the third quarter as it increased research and development spending to support its late-stage clinical pipeline for pemvidutide. Management stated that the company is executing a strategy to build a comprehensive liver disease franchise targeting metabolic dysfunction-associated steatohepatitis and alcohol-related conditions. The company reported that its current cash and investment balance of $480 million is expected to provide funding through the anticipated 52-week data readout for its global Phase 3 MASH trial in 2029. Management indicated that it is evaluating nondilutive funding options and potential strategic partnerships to support the advancement of its alcohol use disorder program following upcoming regulatory discussions.

• Management indicated that the global PERFORMA trial is currently focusing on site activation, with the majority of planned U.S. sites now active and recruiting patients.
• CEO Durso stated, "Our conviction in pemvidutide is stronger than ever, coming out of ASLD's The Liver Meeting, where the data presented further validates the potential of pemvidutide and our overall development strategy."
• The company plans to evaluate pemvidutide doses of 1.8 milligrams and 2.4 milligrams in its Phase 3 programs, following Phase 2 results that showed concurrent improvements in liver fat and fibrosis measures.
• In the AUD program, the company will focus on moderate to severe patients, including a subpopulation with advanced liver impairment, which management believes aligns with current FDA guidance.
• CFO Weaver indicated that the company's preference for funding the AUD Phase 3 program includes potential royalty debt or strategic partnership opportunities to preserve capital.
• The company relocated its corporate headquarters to Morristown, New Jersey, in Nov. 2026 and added two new members to its Board of Directors to support its strategic evolution.

INDUSTRY GLOSSARY

• MASH: Metabolic dysfunction-associated steatohepatitis, a more severe form of fatty liver disease.
• AUD: Alcohol use disorder, a medical condition characterized by an impaired ability to stop or control alcohol use.
• ALD: Alcohol-associated liver disease, liver damage caused by excessive alcohol consumption.
• GLP-1/glucagon: A dual receptor agonist that targets both appetite suppression and direct liver metabolic activity.
• CMC: Chemistry, manufacturing, and controls, the processes used to ensure consistent drug quality and production.
• NIT: Non-invasive test, a diagnostic tool used to assess liver health without a biopsy.
• PEth: Phosphatidylethanol, an objective serum-based measure used to verify alcohol consumption levels.
• WHO RDL: World Health Organization Risk Drinking Level, a standardized measure for categorizing alcohol consumption risks.
• VCTE: Vibration-controlled transient elastography, a technology used in FibroScan to measure liver stiffness.
• ASLD: American Association for the Study of Liver Diseases.

Full Conference Call Transcript

Operator: Good morning. Ladies and gentlemen, and welcome to the Altimmune's Quarter 26 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. To ask a question during the session, you would need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. As a reminder, this call is being recorded. I will now introduce your host for today's conference call, Luis Sanay, Vice President of Investor Relations. Luis, you may begin.

Luis Sanay: Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's third quarter 26 financial results and business update call. On today's call, you will hear from Jerry Durso, our Chairman and Chief Executive Officer. Doctor Christophe Arbet-Engels, chief medical officer, Linda Richardson, chief commercial officer, and Gregory L. Weaver, Chief Financial Officer. Following management's prepared remarks, we will open the line for questions. Our third quarter 26 earnings release was issued this morning and can be found on the Investor Relations section of our website.

Before we begin, I would like to remind everyone that remarks made 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 review of the risk factors that could affect the company's future results and operations, we refer you to our SEC filings. I also direct you to read the forward looking statements disclaimer in our press release issued this morning. Any statements made on this call speak only as of today's date.

11/12/2026, 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 call is being recorded and will be available for audio replay on our website. With that, I will now turn the call over to Jerry.

Jerome Benedict Durso: Good morning, everyone, and thank you for joining us today. We enter the final months of the year with strong confidence in pemvidutide, and the strategy we are laser-focused on executing. Over the course of this year, we significantly advanced our programs across the board in NASH, AUD, and ALD, further strengthening our belief that pemvidutide's differentiated clinical profile can support a broad liver franchise with multiple indications in serious liver diseases. We are now focused on carrying that momentum forward through disciplined execution. We continue to see a growing understanding and scientific support for the potential therapeutic role of PEMVY and its ability to provide meaningful benefit to people affected by serious liver diseases.

Our conviction in pemvidutide is stronger than ever, coming out of ASLD's The Liver Meeting, where the data presented further validates the potential of pemvidutide and our overall development strategy. MASH data presented at several podium talks at the meeting reinforced the potential of the dual glucagon GLP-1 mechanism in MASH. And underscored the differentiation of pemvidutide. We presented new NIT data from our 48-week impact study that highlighted the strong antifibrotic activity of PEMV that continues to compare favorably to data across other trials. We believe pemvidutide's balanced 1-to-1 glucagon to GLP-1 ratio when coupled with our proprietary UPORT domain matters. And results in a molecule that balances metabolic and liver directed activity generally favorable tolerability.

Despite new products entering the NASH field, and others in various stages of development, there remains a significant unmet need for patients. And we believe that pemvidutide could represent a well differentiated MASH therapy. We see a major commercial opportunity across the indications we are targeting as we build our liver franchise. In addition to the unmet need in NASH, we view AUD and ALD as part of a patient continuum as AUD patients often progress to liver impairment. In fact, data referenced at the liver meeting estimates that 55% to 94% of ALD patients also meet the criteria for AUD.

The RECLAIM data highlighted that PEMI has the potential to help address both alcohol consumption and the liver damage that can result from it. Finally, 1 of the recurring themes at the liver meeting was about the overlap of NASH and alcohol use. We believe pemvidutide's differentiated profile positions it well across a multitude patients. Moving now on to execution, which is a critical focus for Altimmune. First, our global PERFORMA Phase III trial is ramping up, and we are very encouraged by the progress to date. Clinical trial sites continue to come online according to our plan, and we are actively enrolling patients. The engagement we see from the PERFORMA investigators and the broader NASH community is strong.

Excitement was quite evident at the liver meeting. Christophe will touch on the positive feedback and engagement from KOLs on Performa and pemvidutide overall. We are also pleased that the IMPACT Phase 2b 48-week efficacy and safety data was published in The Lancet this week. In AUD, the positive RECLAIM Phase II data were highlighted in a late breaking oral presentation. We believe this is the most robust AUD data presented to date. The strong results we saw significantly derisk this program. Importantly, our end of phase 2 meeting with the FDA is scheduled for next month. Representing a key step towards advancing pemvidutide in AUD.

We look forward to engaging with the agency and continuing our progress of PEMVY in the indication. We As part of our continued evolution as a late stage biotech company, we are also thrilled to recently have added Peter Greenleaf, and Alex Horvath to our Board of Directors. Peter and Alex are accomplished industry leaders that bring a breadth of experience across drug development, commercialization, and corporate development. Their experience and strategic perspectives will be valuable to Altimmune as we continue to advance. So in summary, we are committed to executing our strategy with speed and efficiency reflected in the significant progress we have made across the pemvidutide franchise this year.

We are laser focused on delivering on our goals of bringing differentiated therapy in PEMVY to patients and creating value for our shareholders. Our conviction in pemvidutide is stronger than ever and we look forward to sharing our continued progress. I will now turn the call over to Christophe for a clinical update.

Christophe Arbet-Engels: Thank you, Jerry. I would like to start by just stating that I am very pleased with the significant progress we are making as we advance our clinical programs across NASH, AUD and ALD. Beginning with MASH, the global PERFORMA phase 3 trial is underway and progressing as planned. We are screening and dosing patients and clinical site activation continues across the program as we build towards broader global enrollment. We have the majority of planned US sites now active, and recruiting patients, and we expect to activate the ex US sites over the coming months. We will continue to work closely with our CRO partner to support efficient trial execution and enrollment.

Overall, we remain encouraged by the enthusiasm and engagement we are seeing from investigators and clinical sites for PERFORMA based on the product profile and the efficient trial design. As a reminder, we anticipate the PERFORMA 52-week data readout in 2029. Altimmune had a strong presence at the recent Liver Meeting in Denver, where we had the opportunity to highlight the potential of pemvidutide in serious liver diseases. We saw a growing interest and excitement for pemvidutide from the scientific community and the role it may play in treating the liver damage that characterizes the overlapping metabolic and alcohol associated diseases of NASH, AUD, and ALD.

During the liver meeting, we presented 2 analyses from the IMPACT Phase IIb trial including compelling data showing concurrent improvement across multiple non invasive measures of liver fat inflammation and fibrosis compared to patients receiving placebo. The new data further illustrates the strong and consistent antifibrotic activity and a generally favorable tolerability profile in the absence of dose titration. Our data along with emerging data from other glucagon GLP-1 programs reinforce the importance of glucagon in treating NASH. The totality of our learning during the liver meeting further support our Phase 3 study design. We also hosted well attended disease state product theater where Dr. Mazen Noureddin, Dr. Rohit Loomba and Dr. Jessica Mellinger discuss the advanced liver disease continuum.

They noted the prognostic components of fibrosis on outcomes and how various factors, including alcohol consumption or metabolic dysfunction, impact the progression of serious liver disease. The product theater further underscored the overlap between excessive alcohol consumption and metabolic causes of serious liver disease, and the high unmet need for therapy that can chronically address both causes and their liver damage consequences. We believe that the data presented on PEMVY during the liver meetings strongly support the potential of pemvidutide to address that unmet need with a generally well tolerated approach that is particularly suitable for chronic diseases such as MASH, AUD, and ALD in addition, Dr.

Henry Kranzler, the lead investigator for our RECLAIM Phase 2 trial presented a very robust and positive study results in the late breaking oral presentation at the liver meeting. To our knowledge, the reclaim data is the strongest data in AUD to date. The trial showed statistically significant improvements with pemvidutide across the primary endpoint of heavy drinking days, as well as key secondary measures including WHO risk drinking level achievements of 0 heavy drinking days both of which are FDA registrational endpoints. Importantly, we also demonstrated that PEST an objective serum based measure of alcohol consumption, corroborated the self reported reduction in alcohol intake in pemvidutide-treated patients. Pemvidutide also increased abstinence in patients with AUD.

And while RECLAIM was focused on drinking behaviors, the trial demonstrated in an exploratory analysis that PEMVY decreased the proportion of patients with elevated risk for developing advanced liver fibrosis as measured by FIB-4. These data point towards potential liver improvement in this patient population. Given PEMV's direct glucagon effect on the liver, the observed data is very encouraging. And we expect to further evaluate the potential liver benefits in the registrational Phase III study in AUD with inclusion of a subpopulation of AUD patients with advanced liver impairment.

Importantly, RECLAIM was conducted in patients with moderate to severe AUD the population we believe may have the greatest need for more effective and safe treatment options and who are at risk of alcohol related liver disease. The overall strong positive results including the generally favorable safety profile observed in the trial positions us well to engaging with regulatory agencies to align on the next steps for the program. To that end, our end of phase 2 meeting with the FDA is scheduled for December. Where we expect to discuss the study design and regulatory path for a Phase 3 AUD program. Typically, meeting minutes follow within 30 days.

In our registrational program, we will focus on moderate to severe patients, including a subpopulation of patients with advanced liver impairments such as ALD. This approach not only aligns with FDA guidance, where patients with hepatic impairment should be enrolled in AUD registration program, but also may address the current unmet need as therapies for AUD are not specifically indicated in the hepatically impaired subpopulation. In terms of trial design, we expect the primary endpoint to be the WHO RDL with no heavy drinking days as a key secondary endpoint both of which reached statistical significance in the RECLAIM Phase 2 trial. We expect other secondary exploratory endpoints to include additional self reported drinking endpoints.

PET, body weight, and liver endpoints, liver fat content, liver stiffness, measurements, and health. We would look to include both 1.8 milligram and 4 mg doses with a simple 1 to 2 step titration. The PROCURE trial will have a primary efficacy read at 26 weeks, and continue up to 1 year for additional safety and efficacy data. The final program design will of course be subject to our dialogue with regulators. Moving now to ALD. The RESTORE trial enrolled 121 patients with ALD and a history of chronic and heavy drinking at baseline. The 48-week trial is designed to demonstrate the liver benefit over a period of 48 weeks, and includes additional evaluations at 24 weeks.

Given the significant overlap between the ALD and AUD patient population, demonstrating liver benefits in the RESTORE trial could further support a unique role for pemvidutide in decreasing both chronic alcohol consumption and the liver damage it causes. We also believe that the ALD trial will further strengthen our filing package and discussion with regulators when seeking an AUD indication. We expect the top line data for RESTORE in the second half of 27. In summary, the significant progress achieved during 2026 across all our clinical program positions, Altimmune well heading into 2027. I echo Jerry's sentiment that our conviction in pemiglitide is stronger than ever.

We look forward to executing against the key clinical and regulatory milestones ahead moving us closer to bringing pemvidutide to patients. And with that, I will turn the call over to Linda.

Linda Richardson: Thanks, Christophe. Good morning, everyone, and thank you for joining us today. Following the conclusion of the 26 liver meeting, I would like to reflect on why we believe pemvidutide remains well positioned in the NASH and AUD markets as a differentiated potential future therapy. First, new data presented at the liver meeting clearly supports the validity of the dual glucagon GLP-1 mechanism of action in the treatment of NASH. That said, the molecule matters as we see different profiles emerging within the glucagon GLP-1 class. Pemvy's balanced 1-to-1 glucagon GLP-1 ratio has already shown significant early improvements in NASH resolution in our Phase 2b IMPACT study. And strong data on fibrosis improvements based on 24 and 48-week NIT analyses.

In addition to the strong profile of the 1.8 milligram dose we saw in phase 2, the 2.4 milligram dose now being studied in our 52-week PERFORMA Phase 3 MASH trial may offer additional upside in terms of weight loss and efficacy. Our generally favorable tolerability profile seen now across multiple pemvidutide trials, and lack of significant drug interactions, are important product features that should help patients remain on PEMVY therapy as well as continue medications they may be taking for comorbid conditions.

These 2 specific features, in addition to our dual mechanism of action, suggest that PEMVY may play an important future role as a potential combination therapy for NASH patients who do not reach therapeutic goals or cannot tolerate their current therapy. Second, despite the availability of approved therapies in MASH, 1 thing remains clear. A significant unmet need remains. While encouraged by the growth seen to date in the MASH market, diagnosis and treatment rates remain low. But we expect this dynamic to evolve. We also believe that evaluating MASH treatment options for patients will move beyond focusing primarily on diabetes and obesity comorbidities to also address additional needs.

For example, patients diagnosed with NASH who also drink, those who are at risk for sarcopenia and need to preserve lean muscle mass, and postmenopausal women facing decreases in bone mineral density may be important patient segments for pemvidutide in the future. Third, with Pemvy, we have a significant opportunity to potentially redefine what to expect from drug therapy and alcohol use disorder. Based on our specific profile of reducing alcohol consumption, and perhaps demonstrating direct improvements on the liver given our glucagon activity. This could subsequently help activate 1 of the largest underserved markets in The US. As a reminder, approximately 27 million Americans meet the criteria for AUD.

And 12 million of these patients are believed to have moderate to severe AUD. This more advanced segment has the highest risk of progressing to severe liver damage and is where pemvidutide's dual mechanism of action may be most compelling. Christophe highlighted our AUD data from RECLAIM earlier in the call. But I would like to also note that our early mover status in AUD is a competitive advantage for PEMVY as we are generating important new data in this field.

Pemvy's balanced 1-to-1 glucagon GLP-1 ratio providing both metabolic and direct liver benefits generally favorable tolerability profile, lack of significant drug interactions, and simple patient friendly dosing drives significant differentiation versus other therapies in development across NASH, AUD, and ALD. We are excited about PEMVY's potential, confident in our existing data and look forward to sharing additional insights on future calls. Gregory, you will now share our financials for the third quarter.

Gregory L. Weaver: Thank you, Linda, and good morning. Beginning with our financial results for the quarter, R&D expense in Q3 26 totaled 27 million compared to $15 million for the same period prior year. The year over year increase in R&D spend was primarily driven by the initiation of the Phase III trial in NASH and the ongoing phase 2 trial in ALD. Q3 26 R&D spend included $20.3 million of direct costs related to pemvidutide development, of which $10.7 million was for NASH, $4.3 million for the phase 2 ALD and AUD trials, and 5.4 million in CMC related expenses. Q3 26 R&D also included $100,000 in noncash stock compensation.

G&A expenses in Q3 26 were 8.7 million compared to $5.9 million for the same period prior year, as we added additional talent to the company. The increase in G&A was driven by the increase in compensation expenses. and professional fees. Q3 26 G&A included 1.8 million in noncash stock comp. The net loss for the third quarter of 26 was $31.6 million or $0.15 a share compared to a net loss of $19 million or $0.21 a share in the third quarter of 25. Now moving to the balance sheet.

We ended the quarter with $480 million in cash equivalents and investments, Our year to date cash burn tracks in line with plan, and is expected to provide operating runway through the PERFORMA Phase 3 MASH 52-week data readout expected in 2029. In addition, following upcoming regulatory feedback in AUD, we expect to have greater clarity on the scope and investment required for a phase 3 program. In AUD, our preference remains to pursue nondilutive funding for the program, including potential royalty debt or strategic partnership opportunities. Thank you very much. That concludes prepared remarks. I will now turn the call back to the operator for the Q&A session. Operator?

Operator: Thank you, sir. You would need to press 11 on your telephone. To withdraw your question, please press 11 again. Please stand by while we compile the Q&A roster. And I show our first question comes from the line of Thomas Smith from Leerink Partners. Please go ahead.

Thomas Smith: Hey, guys. Good morning. Congrats on all the progress, and for taking our questions. On PERFORMA, I know you have talked about enrollment timelines in sort of the 18 to 24 month ballpark. Just wondering if you could provide an update on how you are tracking here in the early days relative to that time line. And what aspects of the trial design you think will drive preferential enrollment over some of the competing phase 2 or phase 3 programs?

Jerome Benedict Durso: Okay. Thanks for the question, Tom. Good to speak to you. I will start and then Christophe can add in. So as a reminder, our current guidance calls for a readout of PERFORMA in 2029. And as you mentioned, we have been discussing this 18 to 24 month range in terms of the time we think enrollment will take. We are really encouraged on what we are seeing. In the early ramp up as we really focus on site activation. At this point in the study, it is the lead indicator. While we also begin to enroll and dose patients Christophe mentioned in the prepared remarks, that the initial focus, as is typical, has been on The U. S. Sites.

We already have over 70 US sites activated, and we now anticipate in the next period that will also commence on the ex US sites, which take a little bit of time for some of the work that has to happen country by country. So we will we will look to communicate you know, on-site activations periodically as we progress and then we will provide other appropriate updates as the study matures. The second part of your question, Thomas, was around some of the elements happening to make enrollment happen in a in a strong way. And I think we already have some good insight from the U.S. sites, maybe, Christophe, that you can talk about. A little?

Christophe Arbet-Engels: Yeah. Absolutely. So we are early into the study, but we are very, encouraged by what we are seeing, the enthusiasm from the sites, the study design, how it is set up, how we plan the interactions with sites, with. it is making it very attractive for those PI to enroll their patients. So as Jerry said, activation of sites is with our more than 70 site in The U.S. is happening, and we are really happy it is on plan, tracking on plan. And then in the next few weeks or months, we are going to start getting the ex US.

As you know, these are taking time a little more, But the, the enthusiasm we have seen whether in investigator meetings or at ASLD was substantial and really encouraging.

Thomas Smith: that is great. Super helpful. And just, a follow-up if I could. I know it is a liver meeting, Merck also presented some, Phase 2b MASH data for their GLP-1/glucagon agonists that included some histology data at 52 weeks, and also included semaglutide active comparator arm. Just wondering if you could comment on that dataset and what you saw in the profile there relative to PEMVY and any potential learnings or read throughs from that study as it relates to Performa? Thanks so much.

Jerome Benedict Durso: Yeah. So I think, look. We were, interested in the data, of course. We think that dataset further validates the mechanism. Probably, and Christophe can talk a little deeper. Probably gives us a good indicator that 12 months is a good time to read the biopsy, which is what we deployed in Performa. And I also think that, again, the totality of the picture we have seen, we believe that PEMVY compares favorably in all some advantages to patients that will be a big part of what we continue to speak about and to focus on because differentiation from the other options is gonna be key.

Christophe Arbet-Engels: Yep. No. And. Exactly. So this is what we show. What we observed with the efinopegdutide data. And, again, it is 2 separate studies, not a head to head comparison, but the fact that they demonstrated with that open label GLP-1 arm added value of the glucagon components from the GLP-1. there is for us really important. it is now the 3rd or 4th, dual agonist also that validates the, the mechanism, that class. And we like what we see with pemvidutide that tolerability, the strong efficacy are at our 1.8 milligram dose. We will test also the 2.4 milligram dose in our phase 3 performance trial.

So this actually confirmed us, in our assumptions the phase 3 trials and the probability of success for it.

Thomas Smith: Got it. that is helpful. Thank you, guys. Thanks a lot. You.

Operator: Thank you. And I show our next question comes from the line of Michael DiFiore from Evercore. Please go ahead.

Michael DiFiore: Hi, guys. Thanks so much for taking my question. 2 for me. 1 on PERFORMA. Not sure if you disclosed in the past, but what placebo rate and treatment effect did you assume for PERFORMA's fibrosis endpoint? And how does that compare with impact? And then separately, for AUD, you know, now that the phase 2 RECLAIM data had been out for a while, was wondering if the drug related discontinuations cluster around the step up to 2.4 milligrams And does that change how you are thinking about titration? In PERFORMA? Thank you.

Christophe Arbet-Engels: All right. So first, on the PERFORMA, the placebo rate we have taken as we have shared, we have not disclosed the whole statistical details. But as we have shared in we have taken a very conservative approach that is based on what other trials have achieved so far. For approved drugs. Now having said this, as you remember, and as the recent article manuscript that has been published on our 48-week data, our NITs were as much stronger than this. But given the size of the study, and the way to develop such a study, we have to take those assumptions into consideration. Regarding the placebo, again, a couple of things.

We have probably the most robust approach with regard to the bioseries. We have reconfirmed this through AASLD. The part that is important is this AIM-MASH assist as well, the selection of the pathologies. The AIM-MASH assist is something that clearly increase precision accuracy and decrease variability on the biopsy reads. So these are important factors, and that will be playing in our favor if this pan out to be really the case here. On the AUD side, I am. Could you repeat the questions? I think-- Sure. I was saying now that the full phase 2 reclaim data are out, did the drug related discontinuation cluster around the step up to 2.4 milligrams?

And if so, does that change how you are thinking about titration in the Phase 3 PERFORMA MASH trial? Thank you. No. So that does not change anything on the on the phase 3 Performa MAASH trial. Actually it confirms us. These are 2 different populations. We have to be very careful. A couple of learnings here 1, the profile of those AEs is not unexpected, and there is nothing new there. The second, is, in different population, you may see some variability in those AE profiles.

But clearly, in our AUD, the titration for by month of 1 step or 2 step because in our phase 3, we will go also with the 1.8 milligram dose that was extremely well tolerated in the Phase 2 MASH trials. So putting this together were comfortable moving forward and confidence that we can manage and keep the very good tolerability profile that we have seen with pemvidutide throughout different populations. Great. Thanks so much.

Michael DiFiore: Thank you.

Jerome Benedict Durso: Thanks, Michael.

Operator: And I show our next question comes from the line of Eliana Merle from Barclays.

Eliana Merle: This is Joe on for Eliana. Thanks for taking our question. Congrats on the progress. For AUD, could you remind us of the percentage of AUD patients who have obesity, diabetes, and NASH? And if there is any real world evidence from, like, off label GLP 1 you see. AUV.

Christophe Arbet-Engels: So the percentage of patients with AUD in MASH is actually looked at under the umbrella of the MASLD patients. We know that there is more than 10% of this population. Keep in mind that this is not always screened appropriately, that the test, evaluation test is not always done. So it is probably, very much underestimated and actually at AASLD or, again, at the, liver forum, there was a clear overlap between the patients that do have MASLD and the patients that do have and these disease are very much related.

So this is the other things that I wanted to mention is what we know is that on the ALD side, there are more than, they are close to 55% to 94%. So almost all of them that do have AUD. So there is clearly 2 aspect to consider. There is the liver damage in itself, which is at the center of these 2 different pathologies, and there is the different causes. And these seem to have more and more overlap as we as we learn more about these different patients populations.

Linda Richardson: I think the role of obesity also is you clearly see that as a comorbidity in NASH, but you also have calories from drinking, etcetera. So these patients may also be obese and drinking and have NASH. And then ALD, sometimes this dynamic changes, because you can be. You know, have the lean drinking. They are they are drinking. They are not consuming calories. So there is a spectrum with the weight across both MASH AUD and ALD. Different concerns. So clearly, the lean muscle mass sparing elements potentially of our drug will be important in all the populations.

Eliana Merle: And 1 quick follow-up if I can. When can we expect an update on AUD from your learnings from the end of phase 2 meeting with FDA?

Jerome Benedict Durso: So as we announced, we are gonna have that meeting in December. You typically anticipate the minutes coming within 30 days after that, and we would communicate appropriately at that point. As you would expect, we also anticipate dialogue as Thank you. as Christophe mentioned with EMA happening in the first quarter.

Operator: And I show our next question in the queue comes from the line of Kripa Devarakonda from Truist. Please go ahead.

Srikripa Devarakonda: Hi. This is Alex on for Kripa. Question from us. Can you provide an update on how you are thinking about potential partnering or the lack thereof in order to optimize the development of Pemvi in across all 3 indications. If you could provide more detail on how, when or if you would pursue a partnership and what would ultimately be looking for in a partner if they did choose to go that route. Thanks.

Jerome Benedict Durso: So as you can imagine, as our program matures, we are active on this front and fully open to approaching that will help move Pemvy forward and create value As Greg said, in the context of the nondilutive options that we would prefer to fund AUD, that is 1 of them. So, you know, I cannot go into any more detail, than that, but that is how we think about it strategically. While we ensure that we are driving execution on our program as strongly as possible.

Srikripa Devarakonda: All right. Thanks a lot. Congrats on the progress.

Operator: Thank you. Thank you. And I show our next question comes from the line of Catherine Okukone from Citizens. Please go ahead.

Catherine Okoukoni: Hi. This is Catherine on for Jonathan Wolleben. I have a quick question on developmental timelines. So how do you think about kind of prioritizing? You--the meeting's kind of cleared up a lot of the phase 3 design for AUD. But as far as prioritizing, the start of the phase 3, what variables are kind of just gonna determine that? Just any more commentary on how you are sort of thinking about developmental timing. Thank you.

Jerome Benedict Durso: Yeah. I think as we as we, you know, have been have been indicating, the next step in this process is that feedback that we will solicit and discuss with the agency in December. That will allow us to take that important input, around sizing and scoping the trial We will be getting feedback from Europe alongside of that. And, of course, as we said, then the opportunity of ensuring that we are building towards the right kind of value creating funding will be happening. So we are not at a point where we are going to guide specifically on timing, but we think about this in a stepwise approach.

And getting really prepared for that next important step, which is which is that discussion with FDA, next month.

Catherine Okoukoni: Perfect. Thank you.

Operator: Thank you. And I show our next question comes from the line of Roger Song from Jefferies. Please go ahead.

Roger Song: Congrats on the progress, and thanks for taking our questions. This is Peter Chen calling in for Roger Song. Hi, Peter. For AUD from us. Are you still thinking of including lean patients in the AuD phase 3? And if so, have you guys observed a relationship between weight loss and, heavy drinking day reduction in RECLAIM? And did patients with limited weight loss still show an alcohol benefit?

Christophe Arbet-Engels: Yes. So we. All our data, the totality of our data, allows us and we comforted this. Confirmed this with our KOLs that if in our phase 2, we had limited the BMI of the patients to patients above 25. Now we can. We will explore this in the phase 3. So we will have a cohort of patients that are below 25 or normal into our cohorts, and, we will be looking at this With regard to our data, we are still looking at all these different aspects, but it is.

Clearly, there is a good response throughout the different, BMI and, and that is what allows us to include these patients below 25 or makes us comfortable and confident we can include them into the phase 3, program.

Roger Song: Great. Really appreciate the additional color. Thanks, guys. Thank you. Appreciate it.

Operator: Thank you. And I show our next question comes from the line of William Wood from B. Riley Securities.

William Wood: Taking our questions and congrats on the continued progress here. Just to sort of double click on performer execution, Could you comment on how many patients have actually been randomized? And in terms of sort of the mix between U. S. and ex-U.S. I believe you have said that total sites activation will be around 300. So should we expect. You know, is that 70 sort of maxing out in terms of the U.S., and then the rest should be ex US. And then I have a follow-up.

Jerome Benedict Durso: Yeah. So as I said earlier, we are focused on-site activation in this phase while we enroll and start to dose patients. We are not yet at a point where we are gonna comment on specific patient numbers We have talked about that 1 third roughly 1 third of the ultimate study sites will be in The US. So with 70 in. there is some more to happen in the U.S., and, again, that progresses really on a weekly basis. In terms of adding those sites and then the ex US would come next.

Christophe Arbet-Engels: Christophe, maybe any Yeah. No. I mean, this is this is exact. So we are we are. As you understand, then the phasing of those, of these different sites will vary between countries. We have the vast majority of our sites already activated in The US, and this is really, encouraging. And we are moving step by step into the activations of the other countries. Europe, Asia, etcetera will come next So that will bring all these patients Again, to just repeat myself, but we are very encouraged in the, when we see the screening, the number of patients that are coming through the sites right now. By the PI's engagement for the study.

How they respond, and how they were present, and the receptions as well as the number of PIs and sites that have come to our booth at the Liver Meeting was also telling on that interest for the PERFORMA study. So this is working. We are in the early stages, but this is working exactly as planned, and, and we see a great engagement, to work with us.

Jerome Benedict Durso: And, of course, we understand why this is such an important question, and we are thinking about it carefully as we move ahead. And as I said, we will provide the appropriate updates as the study matures And I am sure this will be a source of conversation on each quarterly call.

William Wood: Got it. And then also, for the. For your AUD trial, obviously, we will we will need to wait post end of phase 2. And then, you know, the obviously appropriate time line after that. But just in of when we what is your expectations on when we could actually expect the Phase III to initiate? Is that something that could happen in the first half of next year? And then also based on your development already in MASH, should we expect a safety database should we expect the FDA to require a safety database for AUD or ALD And maybe are you already screening for. With PEth in your MASH trial? Thank you.

Jerome Benedict Durso: So maybe Christophe take that question, then I will come back on how to think about timing.

Christophe Arbet-Engels: So we are definitely using test in our PERFORMA MASH trials. This will be an important evaluation to be done. As we mentioned, pemvidutide has really the potential to treat both the appetites and the metabolic causes of the liver. Serious liver disease as well as alcohol So we are looking at this into our into our phase 3 trial. And, for the AUD, there is a number of steps that we are taking to move forward and we will include patients with also liver impairment or ALD. In that population that do have AUD So this is where we are going right now and working with KOLs, with regulatory agencies to put all these, aspect together.

Jerome Benedict Durso: So, this is a stepwise approach. We talked at the initial top line readout that the next step was to compile the data, submit the data, get the meeting on the books with the FDA. that is the next step now in December. That will allow us, I think, to have a lot of the right inputs to finalize the design of the trial. And then, of course, the funding question's gonna be getting the right the right funding mechanism that we think is in ultimately the best interest of moving the program ahead and in the best interest of the shareholders. So as I said earlier, we are not yet gonna guide to timing, around this.

We will update as we go through these steps. And, you know, underneath that, is that kinda dual objective of trying to move as quickly as we can while also ensuring that each step of the right pros. Of the process is the right thing for the program long term. there is So stay tuned on that.

Christophe Arbet-Engels: Yeah. Just 1. Once you answer the question on the safety database. Obviously, with the number of patients we already have exposed more than 750 patients, we expect to have those discussions with the with the, the regulators and trying to, limit, that safety database to its strict minimum on the specific AUD population and being able to use, the other trials like the MAGE PERFORMA trials or the previous phase 2 trials for, total exposure to the drug.

William Wood: Very helpful. Appreciate it. Thank you very much. Thanks.

Operator: Thank you. And I show our next question comes from the line of Patrick Trucchio from H. C. Wainwright and Co. Please go ahead.

Patrick Trucchio: Thanks. Good morning. A couple of questions. The first is I was wondering how consistent was RECLAIM's drinking across baseline BMI and weight loss subgroups, particularly among patients who maybe lost relatively little weight. And then I am wondering which AUV patient population offered the current initial commercial opportunity for pemvidutide based on the product profile that is emerging and you know, how the drug would be positioned among you know, others in the space, particularly in

Christophe Arbet-Engels: So the data in the reclaim study were remarkably, consistent between the different groups. With a response not only across different measures, as we have we have seen with the PROs and the more objective test measures, but also across subpopulations, gender, BMI, etcetera. So the consistency is what makes that. Those data extremely robust. And I will let Linda answer the questions on the commercial side.

Linda Richardson: Certainly. Thanks, Christophe. Thanks for the question. I think we have mentioned that of the 27 million people who meet the criteria in The US, alcohol use disorder There are roughly 12 million that suffer from or would meet the criteria for moderate to severe And that is where we believe the chronicity of use the binge drinking potential, etcetera, that leads to liver damage, they are the most likely to progress or, in fact, have subclinical underlying damage already that we believe having a direct acting impact on the liver due to the glucagon is very important.

Not only do you have to reduce the drinking behavior, the drinking consumption, the amount of drinking, you also wanna be protected that liver and helping to heal that liver, and that is where the dual mechanism comes and gives us an advantage that we believe will potentially play out in our clinical trials.

Patrick Trucchio: K. Thanks so much. Thanks, Patrick. Thank you, Patrick.

Operator: And I show our next question comes from the line of Annabel Samimy from Stifel.

Annabel Samimy: This is Kyle on for Annabel. You for taking our questions. 2 from us. On the AUD primary, you guys selected WHO RDL and then the 0 h t d as secondary. Just curious why you chose 1 or the other and then how receptive that is from FDA. And then separately on AUD, given that are now 50% cash-pay and, you know, semigenetic in their early 2030s. How do you see your ability to price effectively, and do you envision cash pay and telehealth as strong component of the commercial infrastructure Thank you.

Christophe Arbet-Engels: Alright. So just as a reminder, both of those key secondary endpoints in our phase II study were highly statistically significant. The WHO RDL and the no heavy drinking days. We believe that the WHO. So we had the opportunity to choose any of them. Based on this. And we chose, for right now, we are going to propose the WHO RDL for a couple of reasons. 1, the level of drinking and the risk of drinking is very relevant from an addictive, aspect and we believe that no heavy drinking days is a little less relevant from a clinical point of view. At least this is what we are hearing from our experts, academic experts, or clinician.

So this is a very relevant measures that risk is really important. It allows us also to look at the partial and full remission for these patients in the phase 3. And move in this direction. So this is an important 1. And, again, the results that we are seeing were very robust and very strong.

Linda Richardson: So I will take the second part of that question. Recall that only about. Of all the AUD patients in meeting that criteria, only about 2.2, 2.5% are receiving any kind of pharmacotherapy presently. Our data as far as we are aware, is the strongest data in reduction of drinking and impact on AUD of any company that is presented to date. And the uniqueness of, again, going directly to that liver issue and the tolerability of our product. This is something that patients may need to stay on for a while. We do not know. And the tolerability is going to play in.

So all the features that we see coming from the inherent molecule matters in our in our whole presentation of 1-to-1, we believe will play into the value proposition for pemvidutide and AUD. And we are in conversations. We have had some early work talking to talking to payers and some ad boards and what would it take. How would that look, what would we need to show, what we need to demonstrate, And I think we are well aware of how to approach that and the things that will be But clinically speaking, our data is very strong, and that is the kind of dual help that people will need potentially moving forward.

Annabel Samimy: Okay. Thanks.

Operator: Thank you. And I show our last question in the queue comes from the line of Andy Hsieh from William Blair. Please go ahead.

Andy Hsieh: Thanks for taking our question. You talked about material overlap between AUD, ALD and NASH. So regarding the effect size that we can expect to see from RESTORE reading out the second half of next year, is that 3 to 4 kilopascal demonstrated from the impact study a good metric to look at? Thanks for the question.

Christophe Arbet-Engels: The I cannot guide on the number here for what is happening in the population that we have not yet studied directly. We were really happy with the data we have seen in our MASH with the 3, almost 4 kilopascal in the population. That distinction was extremely strong and, a reminder, this is only at our middle dose, the 1.8 milligram dose. So for the MATCH trial, clearly, this is very encouraging. For the ALD trial, again, if the effect. there is a number of consideration, you would have to assume that the effect is similar in both population. That the timing of this effect is similar as well, all those kind of things.

But this is why we think that having that study will be really important when we look at the AUD indication because it will reinforce our filing package with a really good understanding around that ALD population. We already know that the is a population that is heavily drinking. So we will have the AUD population that is more the regular population, if you wish, but we will also be able to really focus on that, liver impairment, or ALD population. So I think, clearly, we are looking at the FibroScan, the VCTE, the change in, kilopascal, as you are rightly saying.

But so far, it sounds like the direct impact of glucagon on the liver in addition to the impact of GLP 1 on the drinking levels is really a big differentiation from the GLP 1 alone. Especially in those severe and moderate, patients.

Andy Hsieh: Alright. that is very helpful. Thank you. Thank you.

Operator: Thank you. That concludes our Q and A session. At this time, I would like to turn the call back over to management for closing remarks.

Jerome Benedict Durso: Thanks a lot, operator, and thanks, everybody, for joining us today. As you heard on the call today, we remain confident in the opportunity ahead for PEMVY And the franchise that we are building around it. We have several important milestones ahead, so we remain focused on executing with speed and efficiency in advancing this differentiated therapy for patients with serious liver diseases. And creating value for our shareholders. I will end the call with 1 overarching sentiment that should be key takeaway, which is that our conviction in pemvidutide and its potential is stronger than ever. As we look ahead. So thanks again for joining us, and we look forward to updating you on our continued progress.

Have a great day.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

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