Altimmune Q3 2026 Earnings Call Transcript

Altimmune (NASDAQ:ALT) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Altimmune reported a net loss of $31.6 million for the third quarter of 2026, with increased R&D expenses primarily due to the initiation of Phase 3 trials in MASH and ongoing Phase 2 trials in ALD.

The company has $480 million in cash and plans to leverage non-dilutive funding options for future program developments.

Altimmune is advancing pemvidutide, focusing on its potential across multiple liver diseases, including MASH, AUD, and ALD, with significant data presented supporting its efficacy and tolerability.

The global PERFORMA Phase 3 trial is underway, with strong site activation and patient enrollment progress, aiming for a 2029 readout.

The RECLAIM Phase 2 trial for AUD showed robust results, leading to an upcoming end-of-Phase 2 meeting with the FDA to discuss further development plans.

Strategic additions to the Board of Directors aim to enhance drug development and commercialization efforts.

Altimmune remains committed to executing its strategy efficiently and creating shareholder value through its differentiated therapy approach.

Full Transcript

OPERATOR

Good morning, ladies and gentlemen, and welcome to the afternoon third quarter 2026 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again.

As a reminder, this call is being recorded. I’ll now introduce your host for today’s conference call, Luis Sanay, Vice President of Investor Relations. Luis, you may begin.

Luis Sanay (Vice President of Investor Relations)

Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune’s third quarter 2026 financial results and business update call. On today’s call you will hear from Jerry Durso, our Chairman and Chief Executive Officer, Dr. Christoph Arvid Engels, Chief Medical Officer, Linda Richardson, Chief Commercial Officer, and Greg Weaver, Chief Financial Officer. Following management’s prepared remarks, we’ll open the line for questions.

Our third quarter 2026 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, November 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’ll now turn the call over to Jerry.

Jerome Durso (Chief Executive Officer)

Good morning, everyone, and thank you for joining us today. We entered the final months of the year with strong confidence in pemvidutide and the strategy we’re laser focused on executing. Over the course of this year, we significantly advanced our programs across the board in MASH, 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’re 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 pemvidutide 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 AASLD’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 pemvidutide that continues to compare favorably to data across other trials. We believe pemvidutide’s balanced one‑to‑one glucagon to GLP‑1 ratio, when coupled with our proprietary EuPort domain, matters and results in a molecule that balances metabolic and liver‑directed activity with generally favorable tolerability. Despite new products entering the MASH 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’re targeting as we build our liver franchise.

In addition to the unmet need in MASH, 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 pemvidutide has the potential to help address both alcohol consumption and the liver damage that can result from it. Finally, one of the recurring themes at The Liver Meeting was about the overlap of MASH and alcohol use.

We believe pemvidutide’s differentiated profile positions it well across a multitude of patients. Moving now on to execution, which is a critical focus for Altimmune. First, our global PERFORMA Phase 3 trial is ramping up, and we’re very encouraged by the progress to date. Clinical trial sites continue to come online according to our plan, and we’re actively enrolling patients. The engagement we see from the PERFORMA investigators and the broader MASH community is strong. This excitement was quite evident at The Liver Meeting, and Christoph will touch on the positive feedback and engagement from KOLs on PERFORMA and pemvidutide.

Overall, we’re also pleased that the IMPACT Phase IIb 48‑week efficacy and safety data was published in The Lancet this week. In AUD, the positive RECLAIM Phase 2 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 de‑risk 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 pemvidutide in this indication as part of our continued evolution as a late‑stage biotech company.

We’re also thrilled to recently have added Peter Greenleaf and Alex Haworth 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’re committed to executing our strategy with speed and efficiency, reflected in the significant progress we’ve made across the pemvidutide franchise this year. We’re laser focused on delivering on our goals of bringing differentiated therapy in pemvidutide 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’ll now turn the call over to Christoph for a clinical update.

Christophe ArbetEngels (Chief Medical Officer)

Thank you, Gerry. I’d like to start by stating that I am very pleased with the significant progress we are making as we advance our clinical programs across MASH, 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 U.S. sites now active and recruiting patients, and we expect to activate the ex-U.S. 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 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 MASH, AUD, and ALD during the Liver Meeting. We presented two analyses from the IMPACT Phase 2b trial, including compelling data showing concurrent improvement across multiple noninvasive measures of liver fat, inflammation, and fibrosis compared to patients receiving placebo. The new data further illustrate 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 MASH.

The totality of our learnings during the Liver Meeting further supports our Phase 3 study design. We also hosted the well-attended product theater, where Dr. Mason Noureddin, Dr. Rohit Loomba, and Dr. Jessica Mellinger discussed the advanced liver disease continuum. They noted the prognostic importance 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 a therapy that can chronically address both causes and their liver damage consequences.

We believe that the data presented on pemvidutide during the Liver Meeting 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 Krentzler, the lead investigator for our RECLAIM Phase 2 trial, presented the 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 and achievement of zero heavy drinking days, both of which are FDA registrational endpoints.

Importantly, we also demonstrated that PEth, 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 pemvidutide 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 pemvidutide’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 3 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 engage 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 programs, 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, PEth, body weight, and liver endpoints, including liver fat content and liver stiffness measurements. We would look to include both 1.8 mg and 2.4 mg doses with a simple one- to two-step titration.

The Proclus trial will have a primary efficacy read at 26 weeks and continue up to one 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 populations, 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 RESTORE 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 2027. In summary, the significant progress achieved during 2026 across all our clinical programs positions Altimmune well heading into 2027. I echo Gerry’s sentiment that our conviction in pemvidutide 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 (Chief Commercial Officer)

Thanks, Christophe. Good morning, everyone, and thank you for joining us today. Following the conclusion of the 2026 Liver Meeting, I’d like to reflect on why we believe pemvidutide remains well positioned in the MASH 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 MASH. That said, the molecule matters, as we see different profiles emerging within the glucagon GLP-1 class. Pemvidutide’s balanced one-to-one glucagon:GLP-1 ratio has already shown significant early improvements in MASH 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 mg dose we saw in Phase 2, the 2.4 mg 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-drug interactions are important product features that should help patients remain on pemvidutide therapy as well as continue medications they may be taking for comorbid conditions.

These two specific features, in addition to our dual mechanism of action, suggest that pemvidutide may play an important future role as a potential combination therapy for MASH patients who do not reach therapeutic goals or cannot tolerate their current therapy. Second, despite the availability of approved therapies in MASH, one 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 MASH 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 pemvidutide we have a significant opportunity to potentially redefine what to expect from drug therapy in 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 one of the largest underserved markets in the U.S. 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 pemvidutide as we are generating important new data in this field. Pemvidutide’s balanced one-to-one glucagon:GLP-1 ratio providing both metabolic and direct liver benefits, generally favorable tolerability profile, lack of significant drug-drug interactions, and simple patient-friendly dosing drive significant differentiation versus other therapies in development across MASH, AUD, and ALD. We are excited about pemvidutide’s potential, confident in our existing data, and look forward to sharing additional insights on future calls.

Greg, you’ll now share our financials for the third quarter.

Gregory Weaver (Chief Financial Officer)

Thank you, Linda, and good morning. Beginning with our financial results for the quarter, R&D expense in Q3 2026 totaled $27 million, compared to $15 million for the same period prior year. The year-over-year increase in R&D spend is primarily driven by the initiation of the Phase 3 trial in MASH and the ongoing Phase 2 trial in ALD. Q3 2026 R&D spend included $20.3 million of direct costs related to pemvedutide development, of which $10.7 million was for MASH, $4.3 million for the Phase 2 ALD and AUD trials, and $5.4 million in CMC-related expenses.

Q3 2026 R&D also included $1.1 million in non-cash stock compensation. G&A expenses in Q3 2026 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 2026 G&A included $1.8 million in non-cash stock compensation. The net loss for the third quarter of 2026 was $31.6 million, or $0.15 a share, compared to a net loss of $19 million, or $0.21 a share, in Q3 2025.

Now moving to the balance sheet, we ended the quarter with $480 million in cash, cash equivalents and investments. Our year-to-date cash burn tracks in line with plan and is expected to provide operating runway through the 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 non-dilutive funding for the program, including potential royalty, debt or strategic partnership opportunities.

Thank you very much. That concludes prepared remarks. I now turn the call back to the operator for the Q&A session.

OPERATOR

Thank you, sir. As a reminder, to ask a question, you need to press star-1-1 on your telephone. To remove your question, please press star-1-1 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 Learning Partners. Please go ahead.

Thomas Smith (Analyst)

Hey guys, good morning. Congrats on all the progress and thanks for taking our questions on Performa. I know you’ve talked about enrollment timelines in sort of the 18 to 24 month ballpark. Just wondering if you could provide an update on how you’re tracking here in the early days relative to that timeline 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 Durso (Chief Executive Officer)

Okay, thanks for the question, Tom. Good to speak to you. I’ll 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’ve been discussing this 18 to 24 month range in terms of the time we think enrollment will take. We are really encouraged by what we’re 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 US sites. We already have over 70 US sites activated and we now anticipate in the next period that we’ll 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’ll look to communicate on site activations periodically as we progress and then we’ll 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 strong way, and I think we already have some good insight from the sites. Maybe, Christophe, you can talk about that a little bit.

Christophe ArbetEngels (Chief Medical Officer)

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

As you know, these take a little more time. But the enthusiasm that we’ve seen, whether in investigator meetings or at AASLD, was substantial and really encouraging.

Thomas Smith (Analyst)

That’s great. Super helpful. And just a follow-up if I could. I know at the AASLD meeting Merck also presented some Phase 2 MASH data for their GLP-1/glucagon agonist that included some histology data at 52 weeks and also included a semaglutide active comparator arm. Just wondering if you could comment on that dataset and what you saw in the profile there relative to PEMVI and any potential learnings or read-throughs from that study as it relates to Performa.

Thanks so much.

Jerome Durso (Chief Executive Officer)

Yeah, so I think, look, we were interested in the data. Of course we think that that dataset further validates the mechanism probably—and Christophe could 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’ve seen, we believe that PEMBI compares favorably and offers some advantages to patients.

That’ll be a big part of what we continue to speak about and to focus on, because the differentiation from the other options is going to be key.

Christophe ArbetEngels (Chief Medical Officer)

Yeah, no, and exactly. So this is what we observed with the FENO data, and again it’s two 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 component from the GLP-1 is for us really important. It’s now the third or fourth dual agonist also that validates the mechanism, that class, and we like what we see with pemvedutide—the tolerability, the strong efficacy at our 1.8 mg dose.

We will test also the 2.4 mg dose in our Phase 3 Performa trial. So this actually comforts us in our assumptions for the Phase 3 trials and the probability of success for it.

Thomas Smith (Analyst)

Got it. That’s helpful. Thank you guys.

OPERATOR

Thank you. And actually our next question comes from the line of Michael Defury from Evercore. Please go ahead.

Michael Defury (Analyst)

Hi guys, thanks so much for taking my question. Two for me. One, on Performa, not sure if you disclosed in the past, but what placebo rate and treatment effect did you assume for Performa’s fibrosis and MASH resolution, and how does that compare with IMPACT? And separately for AUD, now that the Phase 2 RECLAIM data have been out for a while, was wondering if the drug-related discontinuations clustered around the step up to 2.4 mg, and does that change how you’re thinking about titration in Performa?

Thank you.

Christophe ArbetEngels (Chief Medical Officer)

All right, so first on the Performa, the placebo rate we’ve taken—as we’ve shared, we haven’t disclosed the whole statistical details—but as we’ve shared, 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 needs were 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 biopsy reads. We’ve reconfirmed this through ACLD. The part that is important is this MASH ASSIST as well as the selection of the pathologist. The MASH ASSIST is something that clearly increases precision and accuracy and decreases variability on the biopsy read. So these are important factors and that will be playing in our favor if this pans out to be really the case here.

On the AUD side, could you repeat the question?

Michael Defury (Analyst)

Sure—now that the full Phase 2 RECLAIM data are out, did the drug-related discontinuations cluster around the step up to 2.4 mg and, if so, does that change how you’re thinking about titration in the Phase 3 Performa

Christophe ArbetEngels (Chief Medical Officer)

MASH trial. Thank you. No. So that doesn’t change anything on the Phase 3 Performa trial. Actually it comforts us. These are two different populations, so we have to be very careful. A couple of learnings here. One, the profile of those AEs is not unexpected and there’s nothing new there. The second is in different populations you may see some variability in those AE profiles, but clearly in our AUD the titration for bimonthly of one step or two step—because in our Phase 3 we will go also with the 1.8 mg dose that was extremely well tolerated in the Phase 2 MASH trials.

So putting this together, we’re comfortable moving forward and confident that we can manage and keep the very good tolerability profile that we’ve seen with pemvedutide throughout different populations.

Michael Defury (Analyst)

Great, thanks so much.

Jerome Durso (Chief Executive Officer)

Thank you. Thanks, Michael.

OPERATOR

Thank you. And I’m sure our next question comes from the line of Ellie Murrell from Barclays. Please go ahead.

Joseph (Analyst)

Hi, this is Joseph on for Ellie. 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 MASH? And if there’s any real-world evidence from off-label GLP-1 use in ALD.

Christophe ArbetEngels (Chief Medical Officer)

So the percentage of patients with AUD in MASH is actually looked at under the umbrella of the MetALD patients. We know that there is more than 10% of this population. Keep in mind that this is not always screened appropriately, that the path evaluation test is not always done, so it’s probably very much underestimated. And actually at the AASLD again at the Liver Forum there was a clear overlap between the patients that do have MASH and the patients that do have alcohol, and these diseases are very much related.

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

Jerome Durso (Chief Executive Officer)

I think the role of obesity also is you clearly see that as a comorbidity in MASH, but you also have calories from drinking, etc. These patients may also be obese and drinking and have MASH. And in ALD sometimes this dynamic changes because you can be, you know, have the lean drinking—they’re drinking, they’re 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.

Joseph (Analyst)

And one quick follow-up if I can. When can we expect an update on AUD from your learnings from the end of Phase II meeting with FDA?

Jerome Durso (Chief Executive Officer)

So as we announced, we’re going to 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 Christophe mentioned, with EMA happening in the first quarter.

OPERATOR

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

Alex (Analyst at Truist)

Hi, this is Alex on for Kripa. Question from us: Can you provide an update on how you’re thinking about potential partnering or the lack thereof in order to optimize the development of PEMBI across all three indications? And if you could provide more detail on how, when or if you would pursue a partnership, and what would Altimmune be looking for in a partner if they did choose to go that route? Thanks.

Jerome Durso (Chief Executive Officer)

So as you can imagine, as our program matures we’re active on this front and fully open to approaches that help move PEMBI forward and create value. As Greg said, in the context of the non-dilutive options that we would prefer to fund AUD, that’s one of them. So can’t go into any more detail than that, but that’s how we think about it strategically while we ensure that we’re driving execution on our program as strongly as possible. All right, thanks a lot.

OPERATOR

Thank you. Our next question comes from the line of Catherine Okukone from Citizens. Please go ahead.

Kathryn (Analyst at Citizens)

Hi, this is Kathryn on for John Waldman. I have a quick question on developmental timelines. So how are you thinking about kind of prioritizing the meetings? Kind of clear up a lot of the phase 3 design AUD. But as far as prioritizing the start of the Phase three, what variables are going to determine that? Just any more commentary on how you are thinking about developmental timing? Thank you.

Jerome Durso (Chief Executive Officer)

Yeah, I think as we have been indicating, the next step in this process is that feedback that we’ll 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’re building towards the right kind of value, creating funding will be happening. So we’re not at a point where we’re 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 that discussion with FDA next month.

Kathryn (Analyst at Citizens)

Perfect. Thank you.

OPERATOR

Thank you. Our next question comes from the line of Roger Song from Jefferies. Please go ahead.

Peter Chen (Analyst at Jefferies)

Hey, good morning. Congrats on the progress and thanks for taking our questions. This is Peter Chen calling in for Roger. Just a quick one 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 ArbetEngels (Chief Medical Officer)

Yes. So we, all our data, the totality of our data allows us, and we 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’ll be looking at this with regard to our data. We’re still looking at all these different aspects, but clearly there’s a good response throughout the different BMI, and that’s what allows us to include these patients below 25 or makes us comfortable and confident we can include them into the phase 3 program.

Peter Chen (Analyst at Jefferies)

Great. Really appreciate the additional color. Thanks guys.

Jerome Durso (Chief Executive Officer)

Thank you. Appreciate it.

OPERATOR

Thank you. Our next question comes from the line of William Wood from B. Riley Securities. Please go ahead.

William Wood (Analyst)

Thanks so much for taking our questions and congrats on the continued progress here. Just to sort of double click on Performa execution, could you comment on how many patients have actually been randomized? And in terms of sort of the mix between US and ex-US, I believe you’ve said that total sites activation will be around 300. So should we expect, is that 70 sort of maxing out in terms of the US and then the rest should be ex-US? And then I have a follow up.

Jerome Durso (Chief Executive Officer)

Yeah. So as I said earlier, we’re focused on site activation in this phase while we enroll and start to dose patients. We’re not yet at a point where we’re going to comment on specific patient numbers. We have talked about that roughly one third of the ultimate study sites will be in the U.S., so with 70 in, there’s 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-U.S. would come next. Christoph, maybe any—

Christophe ArbetEngels (Chief Medical Officer)

Yeah, no, I mean, this is exact. So we are, as you understand, the phasing of those different sites will vary between countries. We have the vast majority of our sites already activated in the U.S., and this is really encouraging. And we are moving step by step into the activations of the other countries. Europe, Asia, et cetera, will come next. So that will bring all these patients. Again, to just repeat myself, we are very encouraged when we see the screening, the number of patients that are coming through the sites right now, by the PIs’ engagement for the study, how they respond and how they represent, and the reception, 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 we see a great engagement to work with us.

Jerome Durso (Chief Executive Officer)

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

William Wood (Analyst)

Got it. And then also for your AUD trial, obviously we’ll need to wait post end of phase two and then the obviously appropriate timeline after that. But just in terms of when we, you know, what’s your expectations on when we could actually expect the phase three 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, or 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 Durso (Chief Executive Officer)

So maybe Christoph, take that question. Then I’ll come back on how to think about timing.

Christophe ArbetEngels (Chief Medical Officer)

So we are definitely using PEth in our Performa MASH trials. This will be an important evaluation structure to be done. As we mentioned, Pemvidutide has really the potential to treat both the appetite and the metabolic causes of the serious liver disease, as well as alcohol. So we’re looking at this in our phase 3 trial. And for the AUD, there’s a number of steps that we’re taking to move forward, and we’re enrolling patients with also liver impairments, 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 aspects together.

Jerome Durso (Chief Executive Officer)

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’s 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 is going to be getting 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’re not yet going to guide to timing around this. We’ll update as we go through these steps. And underneath that is that kind of dual objective of trying to move as quickly as we can while also ensuring that each step of the process is the right thing for the program long term. So stay tuned on that.

Christophe ArbetEngels (Chief Medical Officer)

Just want to 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 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 MASH Performa trials or the previous phase 2 trials for total exposure to the drug.

William Wood (Analyst)

Very helpful. Appreciate it. Thank you very much.

OPERATOR

Thank you. And our next question comes from the line of Patrick Truchil from HC Wainwright & Co. Please go ahead.

Patrick Truchil (Analyst)

Thanks. Good morning. Just a couple of questions. The first is I was wondering, how consistent was ReCLAIM’s drinking benefit across baseline BMI/weight loss subgroups, particularly among patients who maybe lost relatively little weight? And then I’m wondering which AUD patient population offers the clearest initial commercial opportunity for pemvidutide based on the product profile that’s emerging and how the drug would be positioned among others in the space, particularly in generics.

Christophe ArbetEngels (Chief Medical Officer)

The data in the ReCLAIM study were remarkably consistent between the different groups, with a response not only across different measures, as we’ve seen with the PROs and the more objective PEth measures, but also across subpopulations, gender, BMI, et cetera. So the consistency is what makes those data extremely robust. And I will let Linda answer the questions on the commercial side.

Linda Richardson (Chief Commercial Officer)

Certainly. Thanks, Christophe. Thanks for the question. I think we’ve mentioned that of the 27 million people who meet the criteria in the U.S. for 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, et cetera, 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 want to be protecting that liver and helping to heal that liver. And that’s where the dual mechanism comes in and gives us an advantage that we believe will potentially play out in our clinical trials.

Patrick Truchil (Analyst)

Thanks so much.

Linda Richardson (Chief Commercial Officer)

Thanks Patrick. Thank you Patrick.

OPERATOR

Thank you. And our next question comes from the line of Annabel Simimi from Stifel. Please go ahead.

Kyle (Analyst at Stifel)

Hi, this is Kyle on Annabelle. Thank you for taking our questions. Two from us, the AUD primary you guys selected WHO RDL and then the 0 HDD secondary. It’s curious why you chose one or the other and then how receptive that is from FDA. And then separately on AUD, given that incretins are now 50% cash pay and semi generic in 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 ArbetEngels (Chief Medical Officer)

All right, so just as a reminder, both of those key secondary endpoints in our phase 2 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’re going to propose the WHO RDL for a couple of reasons. One, 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 practice point of view, at least this is what we are hearing from our experts, academic experts or clinicians.

So this is a very relevant measure. That risk is really important. It allows us also to look at the partial and full remission potentially for these patients in the phase 3 and move in these directions. So this is an important one. And again, the results that were seen were very robust and very strong.

Linda Richardson (Chief Commercial Officer)

So I’ll take the second part of that question. Now recall that only about 2.25% of all the AUD patients meeting that criteria 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’s 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 don’t know — and the tolerability is going to play in. So all the features that we see coming from the inherent molecule matters and our whole presentation of one-to-one, we believe, will play into the value proposition for pemvidutide in AUD. And we are in conversations — we’ve had some early work 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’re well aware of how to approach that and the things that will be important.

But clinically speaking, our data is very strong and that’s the kind of dual action help that people will need potentially moving forward.

OPERATOR

Thank you. And I’m sure our last question in the queue comes from the line of Andy Shea from William Blair. Please go ahead.

Andy Shea (Analyst)

Thanks for taking our question. You talked about material overlap between AUD, ALD and MASH. So regarding the effect size that we can expect to see from RESTORE reading out in the second half of next year, is that three to four kilopascals demonstrated from the IMPACT study a good metric to look at?

Christophe ArbetEngels (Chief Medical Officer)

Thanks for the question. I can’t guide on the number here for what’s happening in a population that we have not yet studied directly. We were really happy with the data we’ve seen in our MASH, with almost 4 kPa in the population. That distinction was extremely strong. And as a reminder, this is only at our middle dose, the 1.8 milligram dose. So for the MASH trial, clearly this is very encouraging. For the ALD trial, again, if the effect is a number of considerations, you would have to assume that the effect is similar in both populations, that the timing of this effect is similar as well, all those kinds of things. But this is why we think that having that study will be really important when we look at the AUD indications, because it will reinforce our filing package with a really good understanding around that ALD population.

We already know that this is a population that is heavily drinking, so we’ll 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’re looking at the FibroScan, the VCTE, the change in kilopascals, as you’re 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 Shea (Analyst)

All right, that’s very helpful. Thank you.

Christophe ArbetEngels (Chief Medical Officer)

Thank you.

OPERATOR

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

Jerome Durso (Chief Executive Officer)

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 PEMBI and the franchise that we’re building around it. We have several important milestones ahead, so we remain focused on executing with speed, with efficiency, and advancing this differentiated therapy for patients with serious liver diseases and creating value for our shareholders. I’ll end the call with one overarching sentiment that should be the 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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