Altimmune, Inc.

Good morning, ladies and gentlemen, and welcome to the Altamune Year-End 2025 Financial Results Conference Call. 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. As a reminder, this call is being recorded. I'll now introduce your host for today's conference call, Lee Roth, President of Burns McLellan, Investor Relations Advisor to Altimmune. Lee, you may begin.

Thanks, Gigi, and good morning, everyone. Thank you for joining us for Altimmune's fourth quarter 2025 financial results and business update conference call. On today's call, you'll hear from Jerry Durso, our Chief Executive Officer, Dr. Christoph Arbett-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 the Q&A session. Our fourth quarter and full year 2025 earnings release was issued this morning and can be found on the investor relations section of the Altamunion website. Before we begin, I'd like to remind everyone that remarks made about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Altamune cautions that these forward-looking statements are subject to risks and uncertainties that could cause our 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 filings with the SEC. I also direct you to read the forward-looking statements disclaimer in our press release issued this morning, which is now available on our website. Any statements made on this call speak only as of today's date, March 5th, 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 the Altamune website. With that, it's now my pleasure to turn the call over to Mr. Jerry Durso, President and CEO of Altamune. Jerry?

Good morning, everyone, and thank you for joining us today for our fourth quarter financial results and corporate update. This is my first earnings call since joining Altimmune as CEO in January. I'd like to start with some comments to reinforce why I'm excited about the opportunities ahead of us with Pemba Dutai. Altimmune is exclusively focused on liver disease, an area where I've spent a good part of my career. Despite a number of therapeutic breakthroughs in the past several years, there remains significant unmet need and treatment gaps among patients living with serious liver diseases like MASH. We believe that Pembidutide has the potential to bring meaningful benefit to people affected by a variety of hepatic diseases. The balanced one-to-one agonism of glucagon and GLP-1 in a single molecule achieved with Pembi makes it potentially well-suited for the conditions we're targeting. Glucagon's direct effect on the liver can drive reductions in liver fat, inflammation, and fibrotic activity, while GLP-1 can mediate weight loss and appetite suppression and may contribute to anti-inflammatory effects. Additionally, PEMBI incorporates our proprietary U-port structure, which slows absorption and is believed to drive improved tolerability, potentially reducing GI and other side effects, which can lead to greater treatment adherence. Importantly, keeping patients on therapy at the right dose is crucial to the management of chronic diseases such as MASH. The data we've generated to date across multiple preclinical and clinical trials, including our Phase IIb MASH study, reinforce our belief in the strong therapeutic potential of Pembidutide, as well as its ability to stand out among competing therapeutic options if approved in MASH. As we evolve the PEMBI plan, we're focused not only on advancing into Phase III, but also ensuring that the potentially unique benefits of PEMBI for patients, payers, and physicians are addressed in our program with a keen eye to competitive advantages in Pembidutide's targeted product profile. Based on our ongoing discussions with hepatology KOLs and other practitioners, it's clear that clinical practice in MASH is evolving and will continue to evolve as new therapies become available. The prevailing sentiment is that no single therapy will be able to effectively address the needs of all patients. This is already being acknowledged by the industry as a number of companies are pursuing combination strategies to meet the needs of broader segments of the patient population. With PEMBIE's dual mechanism, We have a combination therapy in a single molecule with the potential to address both the hepatic and metabolic drivers of disease at once, which could differentiate Pembidutide from these multi-drug approaches that aim to achieve the same benefits we're providing with a single compound. In our Phase II MASH study, Pembi showed strong and early MASH resolution at just 24 weeks and clear antifibrotic activity at 48 weeks. The key measures were consistently moving in the right direction with important non-invasive markers of fibrosis and inflammation improving as therapy progressed in the trial. In addition to efficacy, patients need a therapeutic regimen that they can adhere to in order to realize the full benefit of treatment. As we've shared, the favorable tolerability leading to low discontinuations due to adverse events that we saw in our Phase II MASH trial can be a key differentiator that PEMB may deliver. Likewise, for patients and physicians, the simple dosing aspect of Pembidutide could play an important role. The one- or two-step titration scheme we'll be incorporating into the Pembidutide Phase III trial could prove to be key when compared to the much more complex dosing of other injectable compounds. The potential of PEMVI was recently recognized with FDA breakthrough therapy designation in MASH. Breakthrough is granted to medicines that are intended to treat a serious or life-threatening condition and have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies on a clinically significant endpoint. We look forward to proving this out in our upcoming phase three trial. I hope this gives you some additional perspective into why we're so encouraged about the future of Pembidutide and excited for what's to come. Now, as to how we're preparing to deliver on this potential, One of my top priorities since becoming CEO is strengthening Altimmune's foundation to equip us for the continued successful advancement of Pembe and support our strength as a late stage development company. I'm pleased to report that over the last several months, we've enhanced our team with the addition of new leaders who bring expertise in liver disease, late stage clinical development, commercial strategy, and other key areas. We'll continue to build onto the strong Altimmune team strategically to make sure we're able to deliver. We've also remained focused on strengthening our financial position. The $75 million capital raise completed in January was an important step in our ongoing efforts to prepare for the planned initiation of our phase three this year. We remain committed to securing access to the capital required to successfully drive our clinical programs and create long-term value. At the end of Phase II meeting with the FDA, which was held in the fourth quarter based on 24-week data from our Phase II MASH study, we received valuable guidance on the Phase III trial, and we made excellent progress on the in-depth planning of a major global MASH trial like this. We are clear on the overall design elements and the endpoints, and we're now in the process of making the final detailed decisions on the protocol and the full operational plan. Christoph will share more on the trial with you this morning. While we have significant focus on our MASH program, we're also executing well on our other Phase II trials. As a reminder, last fall, we completed enrollment of the Phase II AUD trial ahead of schedule, and we're now on track to report top-line data from this study in the third quarter of this year. We're also expecting the complete enrollment of our Phase II trial assessing PEMBA and ALD in 2026. PEMBA DUTYD represents a unique and compelling opportunity to improve the lives of people with MASH and other liver conditions. It has the potential to become an important tool for physicians as they look to improve upon the current treatment paradigm. This is a very exciting time for the team at Altamute. We're moving quickly with intent and focus on bringing Pemvidutide to patients and creating long-term value for our shareholders. With that, I'll now turn the call over to Christoph for a clinical update.