Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altamune Inc. Full Year and Fourth Quarter 2022 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 Altimmune. Rich, you may begin.

Thank you, Gigi, and good morning, everyone. Thank you for participating in Altimmune's full year and fourth quarter 2022 financial results and business update conference call. Members of the Altimmune team joining me on the call today are Vipin 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 full year and fourth quarter 2022 financial results was issued this morning and can be found on the investor relations section of the company's website. Before we begin, I would like to remind everyone that remarks 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. Altramine 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 cautionary statements contained in the company's filings with the SEC. I would also direct you to read the forward-looking statement disclaimer 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, Tuesday, February 28, 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 Altimmune's website. With that, I will now turn the call over to Dr. Vipengar, Chief Executive Officer of Altimmune.

Thank you, Rich, and good morning, everyone. We appreciate you joining us today for a discussion of our year-end and fourth quarter 2022 financial results and business update. We are excited about the 2022 achievements with Pembidutide, our GLP-1 glucagon dual receptor agonist. Pembidutide is in development for the treatment of obesity and NASH, two important clinical indications. Altimmune achieved key milestones in the development of pembidutide last year, including completion of our 24-week Phase 1B NAFLD trial with compelling positive data, and the initiation of our 48-week Phase 2 Momentum Obesity Trial. The 24-week data from the NAFLD trial produced a greater than 75% relative liver fat reduction at 24 weeks, with over 50% of subjects achieving normalization of liver fat and significant reductions in serum ALT levels and correlated T1 relaxation times in the 1.8 milligram dose group. Serum ALT levels and CT1 imaging are both established markers of liver inflammation. subjects receiving pambidutide also had a mean weight loss of 7.2%, a placebo-adjusted weight loss of 6% in subjects without diabetes at this dose. This is important because excess body weight is believed to be a major driver of NASH and its comorbidities, and weight loss represents an important therapeutic goal in the treatment of these patients. We believe the robust reduction in liver fat content and markers of liver inflammation together with meaningful weight loss will be important determinants of success in NASH. And because the great majority of people with NASH also have overweight or obesity, we believe pembidutide is uniquely positioned to address these populations effectively. Given these results, we plan to continue development of pembidutide for NASH and expect to initiate a phase 2B NASH trial in mid-2023. Scott Harris will provide more details on this trial shortly. Turning to our phase 2 momentum obesity trial, we are looking forward to announcing the top-line 24-week interim results of approximately 160 subjects in the second half of March. We believe that a level of weight loss consistent with the class-leading obesity drug may be achieved at the end of 48 weeks of treatment, and that potential will be reflected in the interim data readout. We also believe that tolerability profile of pembidutide, together with the absence of dose titration, could translate into improved adherence to therapy and ease of administration, and that a reduction in serum and hepatic lipids and blood pressure may afford benefits to patients at risk of cardiovascular events. In contrast to several other agents in development, reductions in blood pressure are being achieved with pembidutide with minimal increase in heart rate. We believe these attributes could differentiate pembidutide from other drugs in the obesity space and make an important contribution in the treatment of obesity. Finally, enrollment in the Phase II clinical trial of hep T cell in chronic hepatitis B is over 90% complete, and we expect to have a data readout in the first half of 2024. Recall that this trial is designed to show evidence of antiviral effects against hepatitis B virus and establish its potential role in combination therapy for the treatment of this important disease. We're excited about the progress of pembidutide and 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 data and clinical plans. Scott?