Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altamune fourth quarter and full year 2024 financial results conference call. As a reminder, this call is being recorded. 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. I would now like to introduce your host for today's conference call, Lee Roth, President of Burns McClellan, Investor Relations Advisor to Altamune. Lee, you may begin.

Thanks, Gigi. Good morning, everyone, and once again, thank you all for joining us for Altamune's fourth quarter and full year 2024 financial results and business update conference call. On today's call, you'll hear from Dr. Vipin Garg, our chief executive officer, Dr. Scott Harris, our chief medical officer, and Greg Weaver, our chief financial officer. Dr. Scott Roberts, our chief scientific officer, and Ray George, our chief business officer, will join us for the Q&A session. Press release covering our fourth quarter and full year 2024 financial results and corporate update was issued earlier this morning and can be found on the investor relations section of the Altimmune 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. Altimmune cautions you that these forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those expressed today. For a review of the risk factors that could affect our future results and operations, we refer you to the company's filings with the SEC. I direct you to read the forward-looking statements disclaimer in our press release issued this morning, which is also available on our website. Any statements made on this conference call speak only as of today's date, February 27th, 2025, and the company takes no obligation to update any of these forward-looking statements to reflect events or circumstances that may occur on or after today's date. As a reminder, this call is being recorded and will be available for replay on the Altimmune website. With that, it's now my pleasure to turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune.

Vipin. Thank you, Lee. Good morning, everyone, and thank you for joining us for our fourth quarter and full year corporate update. 2024 was a year of significant progress for Altimmune. The milestones we have achieved over the past 12 months have positioned us for transformative catalysts in 2025 and beyond. Following the third quarter 2024 completion of enrollment in IMPACT, our Phase IIb biopsy-based trial of pembidutide in MASH, our top-line data readout remains on track for the second quarter of this year. The dual primary endpoints of the study will be MASH resolution and fibrosis improvement at 24 weeks. Pending these results, we will request an end of phase two meeting with the FDA to align on a registration of phase three program. While the timing of that meeting will be determined by the agency, we expect that it will take place before the end of this year, which would position us to initiate a phase three program in MASH in early 2026. With a positive impact readout, Pembidutide would be the first incretin-based agent to achieve fibrosis improvement at 24 weeks, and the first therapeutic candidate in any class to achieve both significant fibrosis improvement and meaningful weight loss in a 24-week treatment period. We believe that this unique combination of Pembidutide's direct action on the liver together with clinically meaningful weight loss, will position pambidutide to become the treatment of choice in MASH. The ability to reduce fibrosis in only 24 weeks is important because it signals both the potency of pambidutide and the promise of even greater response rates over the longer treatment durations used by other encretin-based agents. In addition to our progress in MASH, I am thrilled to share that we submitted INDs for pembidutide in two additional indications in the fourth quarter of 2024. Both of these INDs have been cleared by the FDA, and this positions us to start Phase II efficacy trials in mid-2025. We believe that each of these indications represents an attractive and compelling commercial opportunity for which pembidutide will be ideally suited. As we announced this morning in our earnings press release, we will be holding a virtual R&D day on March 13th, at which time we will disclose the additional indications and provide detailed overview of these new opportunities. The R&D event will feature presentations by key opinion leaders specializing in MASH, obesity, and the additional indications. We are extremely excited about this event and look forward to sharing our plans on the future of Pembidutide. From an organizational perspective, we are excited by the recent addition of Terry Lauer and Jerry Durso to our board of directors. Notably, they have decades of experience across the pharmaceutical industry, including late-stage clinical development and commercialization of therapeutics in the MASH and metabolic disease space. These areas are highly relevant to Altimmune, and I believe that their expertise and guidance will be invaluable as we embark on our next phase of family duty development. I'm excited to work with them and look forward to their respective contributions. Lastly, I wanted to share with you that Scott Harris, who has served alongside me as our chief medical officer for the last six years, recently informed me that he plans to retire a year from now at the end of February, 2026. Scott has been a valued and trusted colleague whose leadership has been instrumental in advancing pembidutide to the cusp of an important data readout. If successful, this readout could position pembidutide as the foundational therapy in the treatment of MASH and other metabolic diseases. I am grateful that he will remain with us through the impact data readout and the end of Phase II FDA meeting for MASH, and that he has given us ample time to find his successor and to ensure a smooth transition. We plan to initiate a search for his successor in the near future. With that, I'll now turn the call over to Scott Harris. Scott?