Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altimmune Inc. Q1 Earnings 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. If anyone should require operator assistance, please press star zero on your touchtone phone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Rich Eisenstadt. the Financial Officer of Altimmune. Rick, you may begin.

Thank you, Katie, and good morning, everyone. Thank you for participating in Altimmune's first quarter 2022 earnings 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 first 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. Altamine cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including those related to the ongoing conflict in Ukraine, COVID-19, and the impact on our business operations, clinical trials, and results of operations. For discussion of some of the risks and factors that could affect the company's future results, 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 disclosure in our earnings 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, May 12, 2022, 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 Optamine's website. With that, I will now turn the call over to Dr. Vipengar, Chief Executive Officer of Optamine.

Thank you, Rich, and good morning, everyone. We appreciate you joining us today for a discussion of our first quarter 2022 financial results and business update. We continue to advance multiple clinical trials for our lead product candidate, Pembidutide, a GLP-1 glucagon dual receptor agonist, and are excited about reporting important data from these trials in the second half of 2022. Last month, we announced the initiation of the 48-week Phase II Momentum Trial of Pembidutide in subjects with obesity or who were overweight. That trial is ongoing at multiple sites in the United States with Dr. Lou Aroni and professor of clinical medicine at Weill Cornell Medical College and a leading authority in obesity and obesity clinical trials, serving as the principal investigator. Dosing has commenced and a planned interim analysis to assess changes in body weight after 24 weeks of treatment is expected to read out in the fourth quarter of 2022. Enrollment in the phase 1b non-alcoholic fatty liver disease or NAFLD trial has been completed and data readouts for weight loss and liver fat reduction at 12 weeks of treatment are expected in the third quarter of 2022. In addition, a double-blind placebo-controlled 12-week extension of the NAFLD trial has been initiated with an expected data readout on weight loss at 24 weeks in the fourth quarter of 2022. We believe that the 24-week weight loss readout from the NAFLD Extension Trial will provide a valuable read-through to the Phase II Momentum Obesity Trial. A 12-week trial to characterize effects of pembidutide on glucose control in diabetic subjects with overweight and obesity is also ongoing. This trial will further expand on the findings from our phase one trial in which decreased insulin resistance and maintenance of glucose control were observed in an obese and overweight patient population that included subjects with prediabetes. Given the increasing competitive obesity space, it is important to highlight the potential differentiating features of pembidutide. First, we believe we'll be able to achieve weight loss comparable to the results of pediatric surgery, confirming the benefit of adding glucagon agonism to GLP-1 monotherapy. Based on more than 10% weight loss after only 12 weeks, we expect the level of weight loss to be greater and more rapid than other agents in development, increasing patient satisfaction with treatment. In addition, we believe that the absence of dose titration will represent a major advantage in the minds of prescribers, simplifying patient management in the first months of therapy. And finally, we believe that the robust reduction of serum lipids observed in our phase one study could translate into cardiovascular benefit with long-term use, further increasing the value proposition of pembidutide treatment. I want to emphasize that our focus continues to be on obesity as the lead indication for pembidutide. While we believe that our ongoing NAFLD trial will deliver the best liver fat reduction data in clinical trials to date and add significant value to pembidutide, We are not planning to initiate a 52-week biopsy-driven NASH trial at the current time. We believe this decision will create additional flexibility in the development of obesity indication without forfeiting the value of pembidutide in the NASH indication and puts us in a good position to evaluate various strategic options for the continued development of pembidutide. The findings of our preclinical studies in the Gubra mouse model were published last month, and we are excited about the clinical data that we have generated, which we plan to present at international meetings throughout this year. We are pleased to announce that Pembidutide abstracts have been accepted as oral presentations at the 5th Global NASH Congress, the 82nd Annual Meeting of American Diabetes Association and the 2022 meeting of European Association for the Study of the Liver. We hope to announce the publication of these study results in peer-reviewed journals in the near future. Turning to hep T cell, enrollment in our Phase II clinical trial in chronic hepatitis B subjects is ongoing with an expected study readout in the first half of 2023. We are excited about the progress of Pembidutide and Hepticel and the results of ongoing trials. We expect 2022 to be an important year for Altimmune, with three major readouts representing potential significant value drivers for the company. With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plans. Scott?