ALT Q3 2026 earnings call transcript, November 12, 2026

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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. As a reminder, this call is being recorded. I'll now introduce your host for today's conference call. Luis Tenet, Vice President of Investor Relations. Luis, you may begin.

Pemvidutide could represent a well-differentiated MASH therapy. We see 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 reclaimed 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 Ultimune. First, our global PERFORMA phase 3 trial is ran 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 2B 48-week efficacy and safety data was published in The Lancet this week. In AUD, the positive reclaimed 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-risked this program. Importantly, our end of Phase 2 meeting with the FDA is scheduled for next month, representing a key step towards advancing Pemvidutide

and AUD. We look forward to engaging with the agency and continuing our progress of Pembi 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 Harworth 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 Pembidutide franchise this year. We're laser-focused on delivering on our goals of bringing a differentiated therapy in Pembid to patients and creating value for our shareholders. Our conviction in Pembidutide is stronger than ever, and we look forward to sharing our continued progress. I'll now turn the call over to Christophe for a clinical update.

I'd 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 MASH, AUD, and ALD. Beginning with MASH, the global performance free 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 engagements we are seeing from investigators and clinical sites for PERFORMA based on the product profile and the efficient trial design. As a reminder, we anticipated the PERFORMA 52-week data readout in 2029. ALT Immune had a strong presence at the recent liver meeting in Denver where we had the opportunity to highlight the potential of penvidutide in serious liver diseases. We saw a growing interest and excitement for penvidutide 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 illustrates the strong and consistent antifibrotic activity and a generally favorable tolerability profile in the absence of those titrations. Our data, along with emerging data from other glucagon GLT-1 programs, reinforced the importance of glucagon in treating MASH. The totality of our learning during the liver meeting further support our phase three study design. We also hosted a well-attended disease state product theater where Dr. Mazen Noureddin, Dr. Rohit Lumba, 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-end 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 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 Krenzler, the leading

investigator for our RECLAIM Phase II 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 achievements of zero 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 pemvid-treated patients. Pemvidutide also increased abstinence in patients in the U.S. Department of Health and Human Services. with AUD. And while Reclaim was focused on drinking behaviors, the trial demonstrated in an exploratory analysis that Pemvid decreased the proportion of patients with elevated risk for developing advanced liver fibrosis as measured by FIT-4. These data point towards potential liver improvement in this patient population. Given Pemvid'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 two meeting with the FDA is scheduled for December, where we expect to discuss the study design, Bye-bye. and regulatory paths for a phase three AUD program. Typically, meeting minutes follow within 30 days. In our registration 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 impairments should be enrolled in AUD registration programs, but also may address a 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 reach statistical significance in the Reclaim Phase II trial.

Thank you very much.

We expect other secondary exploratory endpoints to include additional self-reported drinking endpoints, PET, body weight, and liver endpoints, including liver fat content, liver stiffness, measurements, and health. 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 would 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 benefits over a period of 48 weeks and includes additional evaluations at 24 weeks. Given the significant overlap between the ALD and the UD patient population, demonstrating liver benefits in the RESTORE trial could further support a unique role for Pembidotide 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 UD 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 program positions ultimune while heading into 2027. I echo Jerry's sentiment that our conviction in Pembidotide

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

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 Pembidotide 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. Pembidotide's balanced 1 to 1 glucagon GLP-1 ratio has already shown significant early improvements in MASH resolution in our Phase IIb 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 II, the 2.4 milligram dose now being studied in our 52-week Performa Phase III MASH trial may offer additional upside in terms of weight loss and efficacy. Our generally favorable tolerability profile, seen now across multiple PEMB2 type trials and lack of significant drug-drug interactions, are important product features that should help patients remain on PEMB 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 PEMB may play an important future role as a potential

company. There is no 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 Pembidutide in the future. Third, with Pembidutide, 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 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. Christoph 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.

We are generating important new data in this field. PEMVid'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 drives significant differentiation versus other therapies in development across MASH, AUD, and ALD. We are excited. about PEMB'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.

Thank you, sir.

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From Lear Rink Partners. Please go ahead.

Thank you for participating.

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