Altimmune, Inc.

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

Thanks, Operator. Good morning, everyone. And once again, thank you for participating in Altamune's third quarter 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 Andrew Shutterly, our acting chief financial officer. Dr. Scott Roberts, our chief scientific officer, and Greg Weaver, our newly appointed chief financial officer, are on the line as well and will join us for the Q&A session. A press release covering our third quarter of 2024 financial results and corporate update was issued earlier this morning and can be found on the investor relations section of the company's website. Before we begin, I'd like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigational Reform Act of 1995. All to me in caution is 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 full 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'll 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, November 12th, 2024, 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. 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, Chief Executive Officer of Altamune. Vipin?

Thank you, Lee. Good morning, everyone, and thank you for joining us for our third quarter corporate update. In the three months since our last conference call, we have achieved several important milestones. These recent accomplishments, coupled with other upcoming catalysts, give us a high degree of confidence that we are in position for 2025 to be a transformational year for Altimmune. First, our Phase 2b IMPACT trial of pembidutide in MASH is now fully enrolled, and top-line efficacy data is expected in Q2 2025. With a successful readout from IMPACT, pembidutide would be the first MASH therapy to achieve both fibrosis improvement and significant weight loss at 24 weeks of treatment. Following this readout, we expect to hold an end-of-Phase II meeting for MASH with FDA in Q4 2025. For our obesity program, as announced last week, we achieved alignment with the FDA at our recent end-of-Phase II meeting on a comprehensive Phase III registration program designed to leverage the key attributes of Pembidutide. The important strategic takeaway here is that we now have a differentiated phase three ready asset that we believe has the potential to benefit obese and overweight patients and fill gaps in the treatment of the comorbidities of obesity left by existing treatments currently on the market. To realize the full potential of Pembidutide, we have made the strategic decision to expand our R&D investments into development of up to three additional indications that leverage the enhanced glucagon activity and other attributes of pemidutide. We plan to submit an IND for the first of these indications by the end of 2024. And preparations are underway for the initiation of that Phase II clinical trial in H1 2025, in the first half of 2025. We believe each of these indications represents a substantial commercial opportunity that will create value for our shareholders. Importantly, these indications were chosen as we believe we can develop these indications ourselves, and we expect to provide more details in the coming months. To summarize, our overarching development strategy continues to focus on securing a partnership centered around obesity, while moving full speed ahead to advance Pembidutide in MASH and launch development efforts in these additional indications. Upon a positive data readout from Phase IIb impact trial in the second quarter of 2025, we expect to be ready to start a Phase III program in MASH by the end of next year. We continue to believe that Pembidutide is a highly differentiated agent from others and in strategically important ways relative to the current metabolic disease landscape. With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our clinical plans in more details. Scott?