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Altimmune, Inc.
5/13/2026
Good morning, ladies and gentlemen, and welcome to the Altamune First 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'll 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, Luis Sine, Vice President of Investor Relations. Luis, you may begin.
Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's first quarter 2026 financial results and business update call. On today's call, you'll hear from Jerry Durso, our President and Chief Executive Officer, Dr. Christoph Arbid 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 first 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. Altamune 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, May 13th, 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 Durso. Good morning, everyone, and thank you for joining us today for our first quarter 2026 financial results and business update call. During our last earnings call, I discussed that one of my first priorities as CEO was to strengthen Altimmune's foundation to equip us for the continued successful advancement of Pemidutide and support our evolution into a late-stage development company. Since the start of the year, we've made significant progress across multiple fronts and are excited about the opportunities ahead of us. Let me take a moment to highlight our recent progress. First, we have continued to enhance and build our team strategically to ensure we are best positioned to deliver on our vision as we enter a new phase for Altamute. We've also remained focused on strengthening our financial foundation. Importantly, in April we completed An oversubscribed public offering resulting in $225 million in gross proceeds. The proceeds from the April offering, along with our existing funds, results in a cash balance of approximately $535 million as of April 30th. We now have the financial resources to fully fund the company through our Phase 3 MASH 52-week data readout, which is expected in 2029. This financing highlights the confidence and the conviction of participating top-tier biotech investors in the potential of Pembidutide and represents another key step towards bringing Pembi to patients. We're entering a new phase for the company with the right team in place and a very strong balance sheet, and we're now focused on execution and believe we're well-positioned to successfully execute our strategies. 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 PEMVI makes it potentially well-suited for the liver conditions we're targeting. Additionally, PEMVI incorporates our proprietary U-port structure, which slows absorption and is believed to drive improved tolerability, potentially reducing GI and other side effects. This 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. Recent market research we've conducted points to attributes that would drive prescribing in MASH, including a highly favorable tolerability profile that does not sacrifice efficacy and quality weight loss. These are two of the potentially differentiating characteristics of Pembidutide based on our clinical trials to date. As the MASH market continues to evolve, There remains a significant unmet need, and we believe PEMV has the potential to offer a differentiated profile for patients. Furthermore, the potential of PEMV has been recognized with breakthrough therapy designation in MASH by the FDA. We're continuing to advance our efforts and expect to initiate our global phase three study in MASH in the second half of this year. The MASH phase three trial will be called the PERFORMA trial. We've now finalized the study protocol and submitted that to the FDA as part of the standard process. We've also completed the scientific advice process in Europe, and the final study protocol is aligned with the feedback we've received from EMA. So Altimmune is fully focused on the startup phase for a large global phase three trial. We're moving quickly, partnering with the CRO who brings deep know-how in the MASH phase three space. The Altimmune team is working closely with them and we're progressing to activate the most experienced trial sites, and then we'll look forward to initiating patient screening. While we have significant focus on our lead MASH program and initiating the performance study, we're also progressing on two additional indications. First, in AUD, an area of high unmet need, we remain on track to report top line data from our phase two trial next quarter. We remain encouraged by the strong scientific interest in this indication, and look forward to the data readout. In ALD, we now expect a complete enrollment of the RESTORE trial in the third quarter of this year. Pemba Dutide 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 and meet the needs of their patients. With a stronger team in place and cash run way through the top line readout of our PERFORMA phase three MASH trial, we're now laser focused on execution. We're moving with urgency on bringing PEMV to patients who may benefit from its promising therapeutic profile and creating long term value for our shareholders. With that, I'll turn the call over to Christoph for a clinical update.
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