8/12/2025

speaker
Olivia
Operator

Good morning, ladies and gentlemen, and welcome to the Altimmune Second Quarter 2025 Financial Results Conference Call. At this time, all participants are on 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 will need to press star 11 on your telephone. You will then hear an automated message, but your hand is raised. As a reminder, this call is being recorded. I'll now introduce your host for today's conference call, Lee Roth. President of Burns MacLennan, Investor Relations Advisor to Altimmune. Lee, you may begin.

speaker
Lee Roth
President of Burns MacLennan, Investor Relations Advisor to Altimmune

Thanks, Olivia. Good morning, everyone. Once again, thank you for joining us for the Altimmune Second Quarter 2025 Financial Result 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 Jort, our chief business officer, will join us for the Q&A. Our second quarter 2025 financial results and corporate update press release was issued earlier this morning, and it can be found on the investor relations section of the Altamune 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 Security Mitigation Reform Act of 1995. All too many cautions that these forward-looking statements are subject to risks and uncertainties, and these could cause our actual results to differ materially from those indicated. For a full review of the risk factors that could affect the company's future results and operations, we refer you to the company's filings with the SEC. I also direct you to read the forward-looking statement disclaimer in our press release issued this morning, which is available on our website. Any statements made on this call speak only as of today's date, August 12th, 2025, and the company does not undertake any obligation to update any 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 my pleasure to turn the call over to Dr. Vipin Garg, President and Chief Executive Officer of Altamune. Vipin.

speaker
Dr. Vipin Garg
President and Chief Executive Officer of Altimmune

Thank you, Lee. Good morning, everyone, and thank you for joining us today for our second quarter financial results and corporate update. As many of you know, we presented the 24-week top-line data from the IMPACT trial at the end of June. As we shared, PEMBD-Utide achieved statistical significance in the primary endpoint of MASH resolution and across multiple objective measures of efficacy at 24 weeks of treatment. These included all non-invasive markers of inflammation and fibrosis, liver fat reduction, and weight loss, along with best-in-class safety and tolerability without the need for dose titration. These data will serve as the foundation of the package that we take to the FDA for our end of phase two meeting in the fourth quarter, and will inform the design of our phase three program. In addition to the advancement of our MASH program Our Phase II trials in AUD and ALD, Reclaim and Restore, are now underway. Alcohol use disorder and alcohol-associated liver diseases are two indications with significant unmet needs and few to no treatment options, for which we believe pembidutide may be particularly well-suited. As we announced yesterday, our board has appointed Jerry Durso as chairman of the board. succeeding Dr. Mitch Sayre, who has served in this role for the past seven years and will remain with us as a non-executive director. This change reflects our planned advancement to Phase III development of Pembidutide in MASH. Jerry has a wealth of commercial and corporate development experience, including the building of a successful liver franchise as CEO of Intercept prior to its acquisition. We are excited to continue moving forward under Jerry's leadership and look forward to Mitch's ongoing contribution. With the $183.1 million in cash and cash equivalent, we have considerably strengthened our balance sheet as we work to continue to advance the development of Pembidutide and look forward to reaching additional milestones, including the full 48-week impact data as the year progresses. With that, I'll now turn the call over to Dr. Scott Harris, our Chief Medical Officer, to provide a clinical development update. Scott?

Disclaimer

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