Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altimmune Inc. Q2 Financial Results Conference Call. At this time, all participants are in the 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 Eisenstad, Chief Financial Officer of Altimmune. Rich, you may begin.

Thank you, Carlo, and good morning, everyone. Thank you for participating in Altamune's second quarter 2022 financial results conference call. Members of the Altamune 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 second 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'd 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. Altamene 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 a 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 foreign looking statements 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, Thursday, August 11, 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 Altamune's website. With that, I will now turn the call over to Dr. Wippengard, Chief Executive Officer of Altamune.

Thank you, Rich, and good morning, everyone. We appreciate you joining us today for a discussion of our second quarter 2022 financial results and business update. We continue to advance multiple clinical trials for our lead obesity product candidate, Pembidutide, a GLP-1 glucagon dual receptor agonist, and are excited about reporting important data from these trials in the coming months. One thing that has become abundantly clear over the last 12 months is that we now have two truly effective drugs to combat the obesity epidemic, and with promising additional drugs on the horizon. Given the increasingly competitive obesity space, it's important to highlight the potential differentiating features of PEMVDU diet. First, we believe that we have the potential to achieve weight loss equal to or exceeding 20% after only 48 weeks of treatment, confirming the benefit of adding glucagon agonism to GLP-1 monotherapy. We also believe the robust reduction of serum lipids observed in our Phase I trial could translate into important cardiovascular benefits with long-term use, further increasing the value proposition of our drug candidate. Finally, we believe that the absence of dose titration will be viewed as a major advantage in the minds of prescribers and patients, simplifying management by avoiding the cumbersome use of dose titration over the first four to five months of therapy. We are planning to announce the top-line data readout on our Phase 1b multi-center trial in subjects with obesity or overweight and non-alcoholic fatty liver disease, or FLD, in mid-September. The key readouts will include assessment of liver fat, weight loss, serum lipids, and safety at 12 weeks of treatment. Scott Harris will join us shortly to discuss our expectations for that readout. In addition, we are currently executing a 12-week double-blind, placebo-controlled extension to this trial and expect data readout after 24 weeks of treatment in Q4 2022. We believe that the 24-week readout will provide valuable information about the weight loss that could be achieved with Pembidutide at one year of treatment. Our 48-week Phase II Momentum Trial of Pembidutide in subject with obesity and overweight is enrolling rapidly. Approximately 25 obesity study centers are now enrolling in the trial across the United States. As of yesterday, August 10, we had randomized 167 subjects, and we expect to fully enroll the 320 subject trial population by the end of this third quarter. A 24-week interim analysis, which was initially planned at year-end 2022, is now planned for Q1 2023, when we expect that approximately 50% of the subjects have been treated for 24 weeks. We believe the interim readout on 50% of the subjects in our trial would provide a more meaningful and robust data set in our evaluation of pembidutide. Scott Harris will talk more about the MOMENTUM trial shortly. A 12-week phase 1b multicenter trial in type 2 diabetics is also ongoing, and we expect this trial to provide important information on parameters of glucose control such as hemoglobin A1C in subjects with obesity and overweight who have type 2 diabetes. Finally, we are continuing to enroll in our phase 2 multicenter trial of hep T cell in subjects with inactive chronic hepatitis B and expect to have a data readout in the second half of 2023. We are excited about the progress of PAMV DUTYTE and hep T cell and the upcoming results of these ongoing trials. 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?