Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altamune Inc. Second Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. To ask a question during the session, you will need to press star 1-1 on your telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Rich Eisenstadt, Chief Financial Officer of Altamune. Rich, you may begin.

Thank you, Gigi, and good morning, everyone. Thank you for participating in Altamune's second quarter 2023 financial results and business update conference call. Members of the Altamune team joining me on the call today are Vip and Garg, our Chief Executive Officer, Scott Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question and answer session. A press release with our second quarter 2023 financial results was issued 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 are constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Autoimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. For discussion of some of the risks and factors that could affect the company's future results and operations, please see the risk factors and other questionnaire statements contained in the company's filings with the SEC. I would also direct you to read the forward-looking statement disclosure in our press release issued this morning and now available on our website. Any statements made on this conference call speak only as of today's date, Thursday, August 10, 2023, 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 conference call is being recorded and will be available for audio replay on Altamine's website. With that, I will now turn the call over to Dr. Vipin Garg, our Chief Executive Officer.

Thank you, Rich, and good morning, everyone. We appreciate you joining us today for the discussion of our second quarter 2020 Financial Results and Business Update. We are excited about the progress of our lead product candidate, Pembidutide, a GLP-1 glucagon dual receptor agonist in development for both obesity and NASH. We recently announced the initiation of our Phase IIb IMPACT biopsy-driven trial to evaluate the efficacy and safety of Pembidutide in NASH. Given the compelling 12- and 24-week data, from our Phase 1b trials in subjects with NAFLD. We expect to achieve significant rates of NASH resolution and fibrosis improvement at data readout from the IMPACT trial, which is anticipated in Q1 to 2025. The data from our NAFLD trial demonstrated a greater than 75% relative reduction in liver fat at 24 weeks. with over 50% of subjects achieving the high bar of normalization of liver fat in the 1.8 milligram dose group. Subjects also had a mean weight loss of up to 7.2% at 24 weeks in the 1.8 milligram dose group, with weight loss continuing at the end of treatment. We also achieved significant reduction in serum ALT and MRI-based corrected T1 imaging, both important markers of NASH improvement. We believe that a robust reduction in NASH activity combined with fibrosis improvement and meaningful weight loss will be essential for a competitive product in the NASH marketplace. With regards to obesity, we look forward to reporting top-line 48-week data from our phase two momentum trial in the fourth quarter of this year. The momentum interim results of 160 subjects reported earlier this year showed weight loss of 10.7% at the 2.4 milligram dose and 9.4% at the 1.8 milligram dose compared to a 1% weight loss in subjects receiving placebo after only 24 weeks of treatment. These robust reductions in body weight together with the effects of pembidutide on serum lipids and blood pressure without cardiovascular safety signals suggest that if approved, pembidutide can be an important treatment option for patients with obesity, especially those with NAFLD or dyslipidemia. It's important to point out that these two comorbidities are prevalent in 60% to 75% of the obesity population. Finally, we have to have a data readout from our Phase II clinical trial of hep T cell in chronic hepatitis B in the first quarter of 2024. Recall that this trial is designed to show evidence of antiviral effects against hepatitis B virus and establish the role of hep T cell in combination therapy for the treatment of this unmet need. They're excited about the progress of pambidutide in hep T cell and the upcoming results of these ongoing trials. With that, I now turn the call over to our chief medical officer, Dr. Scott Harris, to discuss our clinical plans. Scott?