Altimmune, Inc. Common Stock 2026 Q2 Earnings Call

Luis, you may begin. Thank you, operator, and good morning, everyone.

Thank you for joining us for Altimmune's second quarter 2026 financial results and business update call. On today's call, you will hear from Jerome Durso, our Chairman and Chief Executive Officer, Dr. Christophe Arbet-Engels, Chief Medical Officer, Linda Richardson, Chief Commercial Officer, and Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we will open the line for questions. Our second quarter 2026 earnings release was issued this morning and can be found in 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 the purpose 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, August 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.

Good morning, everyone. Thank you for joining us today for our second quarter 2026 financial results and business update call. 2026 is proving to be a year of significant progress as Altimmune evolves into a late-stage company dedicated to serious liver diseases. We have been laser focused on execution since the beginning of the year and believe we are well positioned to advance our strategy and deliver on our mission. Pemvidutide is our foundation, and our confidence and conviction in its potential continues to strengthen with the growing body of clinical evidence. We are building momentum across our pemvidutide franchise and are excited for the future. Let me take a minute to highlight our recent progress. Starting with MASH. Last week, we announced the initiation of the PERFORMA phase III trial as we began enrolling patients in the global program.

We worked with urgency to get the trial started quickly, just 3 months after securing the financial resources to fund the study through the 52-week readout. We're very encouraged by the start of the trial. Sites are being activated quickly, and we're seeing great engagement by the medical community about what PERFORMA may mean for the MASH treatment landscape. There remains a significant unmet need in MASH. We believe pemvidutide, with its balanced one-to-one glucagon and GLP agonism in a single molecule, has the potential to offer a differentiated profile for MASH patients. Moving now to alcohol use disorder, or AUD. We were pleased to report positive top-line data from the RECLAIM phase II trial last month. Pemvidutide delivered a very strong, statistically significant, and clinically meaningful reduction in heavy drinking days, which was the trial's primary endpoint.

The study also met important secondary endpoints, including a two-level reduction in WHO risk drinking levels and zero heavy drinking days. It's important to note that either of these two measures are currently accepted as FDA registrational endpoints. The totality of the top-line data from RECLAIM strengthens our conviction in pemvidutide's potential in AUD. We're moving quickly to gather the full data from the trial, then prepare the data package to request an end of phase II meeting with the FDA to discuss next steps. These compelling data, which to our knowledge are the most robust presented in AUD, further strengthens the potential of pemvidutide as a differentiated therapy across serious liver diseases.

The results from this trial are also meaningful for the AUD patient community, where pemvidutide could represent an important advancement in an area that has lacked innovation for the past two decades, and again, where a significant unmet need remains. There are approximately 12 million adults in the U.S. with moderate to severe AUD. It's well accepted that this AUD population is more likely to develop liver disease. We believe pemvidutide is uniquely positioned to benefit these higher risk patients, as its dual mechanism can address the totality of disease by reducing alcohol cravings while also providing a direct effect on the liver. This population could serve as a key commercial opportunity with substantial future sales potential. Pemvidutide has the potential to help address the continuum of liver diseases we're targeting, MASH, AUD, and ALD.

We've now delivered strong phase II data in yet another indication, and we're well on our way towards building our pemvidutide liver franchise. We're committed to executing our strategy with speed and efficiency, and the significant progress we've made this year reflects that commitment. We remain laser-focused on executing on our goal of bringing pemvidutide to patients who may benefit from its promising and differentiated therapeutic profile and creating value for our shareholders. With that, I'll turn the call over to Christophe for a clinical update.

Thank you, Jerry. I am very excited to share that we continue to advance our clinical programs across MASH, AUD, and ALD. Beginning with our program in MASH. Last week, we announced the initiation of the global PERFORMA phase III trial of pemvidutide in MASH and began enrolling patients. Over the last few months, we moved very rapidly to set up a strong and experienced global infrastructure to initiate the trial. The trial will be conducted across approximately 300 sites, with one-third in the U.S. and two-thirds ex-U.S. We are working closely with our CRO on site activation in multiple countries and ensuring a smooth start to the trial for an efficient enrollment. The initiation of PERFORMA is an important milestone for Altimmune and for the advancement of MASH treatment. We also see a growing interest and excitement for pemvidutide in MASH from the scientific community.

Our increased presence and engagements with the scientific community at the EASL and SOLAR medical conferences this year is driving awareness and has helped build momentum as we begin enrolling patients. Based on the strong phase II data we reported last year and the design of the PERFORMA trial, we are looking forward to studying pemvidutide in a registrational setting. Moving to AUD. In July, we were very happy to report the strongly positive top-line data from the RECLAIM phase II trial in AUD. The data readout was based on an ITT analysis as it would be for a pivotal study. The trial met its primary endpoint, where pemvidutide 2.4 milligram showed a highly statistically significant reduction in the average number of heavy drinking days versus placebo at week 24, with a treatment difference of 1.45 heavy drinking days per week.

Pemvidutide also met two critical secondary endpoints, both of which are registrational endpoints recognized by the FDA. On the first endpoint, we saw a highly statistically significant response in the two-level reduction in WHO-RDL versus placebo. Roughly two-thirds of pemvidutide patients achieved a two-level reduction in WHO-RDL versus only one-third on placebo. On the other FDA registrational endpoint of zero heavy drinking days, one that has historically been challenging to achieve, pemvidutide again showed a highly statistically significant improvement in percentage of patients with zero heavy drinking days. In this data, more than twice the number of the pemvidutide patients achieved zero heavy drinking days versus placebo patients. The trial also saw a highly statistically significant change in the percentage of days with drinking abstinence and PEth levels, which is an objective blood-based measure of recent alcohol intake over the last two to four weeks.

Pemvidutide also showed a meaningful and statistically significant reduction in body weight from baseline, with a 9.1% reduction with pemvidutide versus placebo. The totality of the data, including patients' reported measures such as the decrease in heavy drinking days, WHO-RDL reduction, and the increase in zero heavy drinking days, as well as the PEth objective measure of alcohol intake, shows strong and consistent evidence in pemvidutide's potential to address the excessive alcohol usage in AUD patients. Considering the landscape of clinical studies in AUD, including looking at other available GLP-1-AUD trials, the totality of the RECLAIM data is, to our knowledge, the most robust to date. While RECLAIM was focused on drinking behavior, we evaluated in an exploratory manner whether patients with elevated FIB-4 above the threshold of 1.3 at baseline were seeing any improvement. FIB-4 is an established biomarker correlated with risk for developing liver fibrosis.

Given pemvi's direct glucagon effect on the liver, the observed data with 50% of pemvidutide patients with a FIB-4 index above 1.3 at baseline achieving less than 1.3 after only 24 weeks, versus only 17% in placebo, is very encouraging, especially at such an early time point. We expect to further evaluate the potential liver benefit in a phase III study in AUD. In terms of safety and tolerability, pemvidutide continued to demonstrate a generally consistent safety and tolerability profile. Let me share a few thoughts as we look ahead to a potential phase III study in AUD, which of course will be subject to our dialogue with U.S. and European regulators. We would plan a phase III study in the moderate to severe AUD population. It is important to note that approximately 50% of AUD patients also have ALD.