Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altamune Inc. full year-end Q4 earnings conference call. At this time, all participants are in 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 then zero on your touchtone telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Rich Eisenstadt, Chief Financial Officer at Altamune. Rich, you may begin.

Thank you, Jonathan, and good morning, everyone. Thank you for participating in Altamune's full year and fourth quarter 2021 earnings conference call. Members of the Altamune team joining me on the call today are Vivian Garrett, 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 2021 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. Alderman 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 COVID-19 and its 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, and 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, Tuesday, March 15, 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 Altamine's website. With that, I will now turn the call over to Dr. Vipengar, Chief Executive Officer of Altamine.

Thank you, Rich, and good morning, everyone. We appreciate you joining us today for a discussion of our year-end and fourth quarter 2021 financial results and business update. 2021 was a very productive year for the company as we achieved a key phase one data set in the development of our lead product candidate, Pembidutide. We announced positive data from a 12-week phase one placebo-controlled single and multiple ascending dose trial in volunteers with obesity and overweight that showed a mean weight loss of 10.3% was achieved with a 1.8 milligram once weekly subcutaneous dose. with no serious or severe treatment emergent adverse events or discontinuations for adverse events. Moreover, this favorable tolerability profile was achieved without the need for dose titration. We also demonstrated a greater than 90% reduction in liver fat content in subjects with hepatic steatosis, with liver fat decreasing below the limit of detection after only six weeks of treatment. In the fourth quarter of 2021, we announced that we initiated a 12-week phase 1B trial of pembidutide in subjects with non-alcoholic fatty liver disease, or NAFLD. That trial is ongoing at multiple sites in the United States with Dr. Steven Harrison, a renowned expert in the field of NASH and liver diseases, serving as the principal investigator. Enrollment in this trial is over 90% complete, and a data readout is expected in the third quarter of 2022. In addition, we initiated a 12-week extension to this trial, which when combined with the first trial, will allow subjects to receive treatment for up to 24 weeks. This will enable comparison to the weight loss achieved with semaglutide and trizepatide at the six-month time point. We expect to report this important readout in the fourth quarter of 2022. Early this year, we received IMD clearance from the FDA to evaluate pambidutide for obesity, and we are preparing to commence enrollment in the 48-week Phase II Momentum Trial of Pembidutide in Obesity later this month. The name reflects the rapidity of weight loss and Altimmune's firm commitment to the treatment of obesity. An interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with data expected in the fourth quarter of 2022. This means that we expect to have 24-week readouts on weight loss from two separate clinical trials of pembidutide in 2022. Looking to other studies in 2022, we recently initiated a 12-week trial to characterize effects of pembidutide on glucose control in subjects with type 2 diabetes as a follow-on to our recently completed first in human phase one trial where we demonstrated excellent maintenance of glucose control in subjects with prediabetes with concomitant decrease in insulin resistance. We are also completing a phase one drug-drug interaction trial to evaluate any potential interactions of pembidutide with commonly used drugs. The results of both of these trials are expected in the middle of 2022. Finally, we anticipate the launch of a 52-week biopsy-driven Phase II NASH trial in the fourth quarter of 2022. Based on the remarkable effects of pembidutide on liver fat reduction in our first in-human clinical trial, we expect robust effects on NASH, histology, and other clinical endpoints. Turning to hep T cell, enrollment in our Phase II clinical trial in chronic hepatitis B subjects is ongoing, with study readout expected in the first half of 2023. We are excited about the progress of Pembidutide in hep T cell and the data we have generated so far. We expect 2022 to be an important year for Altimmune with three major readouts representing significant potential value drivers for the company. With that, I will now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plan.