Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altamune, Inc. Q3 Earnings Conference Call. At this time, our 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 then zero on your touchtone telephone. As a reminder, this call may be recorded. I would now like to introduce your host for today's conference call, Will Brown, Chief Financial Officer of Altamune, Will, you may begin.

Thank you, operator, and good morning, everyone. Thank you for participating in Altimmune's third quarter 2021 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 third quarter 2021 financial results was issued last night and can be found on the IR 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. Altamune cautions that these forward-looking statements are subject to risk and uncertainties that could cause actual results to differ materially from those indicated and including those related to COVID-19 and its 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 forward-looking statement disclaimer in our earnings press release issued yesterday and now available on our website. Any statements made on this conference call speak only as of today's date, Wednesday, November 10, 2021, 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. Vipengard, Chief Executive Officer of Altamune.

Thank you, Bill, and good morning, everyone. We appreciate you joining us today for a discussion of our third quarter 2021 financial results and business update. The third quarter has been a very productive time for the company as we reached several key milestones in the development of Pembe Dutide. First, we delivered on the 12-week phase one study results in our trial in overweight and obese subjects. The data we generated exceeded our expectations. as we demonstrated double-digit weight loss in the 1.8 milligram arm, with favorable effects observed on blood pressure, serum lipids, and other measures. We believe we achieved a high watermark in weight loss, given that dose titration was not used and there were no modifications to diet or physical activity. Most other programs in this class of drugs must use dose titrations. that is, gradually increase dose to maintain tolerability. Dose titration presents considerable challenges for patient satisfaction and compliance, and logistical challenges for time-constrained primary care physicians charged with prescribing these therapies. So it's highly encouraging that with straight dosing, we saw primarily mild GI side effects with no study discontinuations due to adverse events. The next key milestone we met was the acceptance of our U.S. NASH IND for pembidutide and the initiation of a 12-week Phase 1b NAFLD clinical trial to explore pembidutide's effect on liver fat in the NAFLD population. We are highly encouraged at the prospects of this trial as we announced this morning the results from exploratory analysis that all of the patients with hepatic steatosis or fatty liver in the phase one trial that received 1.8 milligram or 2.4 milligram of pembidutide experienced reduction in liver fat to undetectable levels after only six weeks of treatment. These findings speak to the potency of pembidutide both to induce weight loss and quickly move fat out of the liver. We look forward with great anticipation to the results of the 12-week Phase 1b NAFLD data, which are expected in the first half of next year. Looking to the future, we are diligently working to submit an IND for pembidutide in obesity to enable a 48-week Phase 2 trial to study weight loss in obese subjects. This is an important program for the company as patients with obesity are grossly underserved. There is a tremendous market opportunity for effective therapies that safely induce meaningful weight loss. And should future data continue to reflect our recent experience, we believe that pembidutide could be a highly effective tool to address the obesity endemic. Finally, we continue to execute on our Phase II trial of hep T cell in chronic hepatitis B, with clinical trial sites enrolling patients across North America and Europe. We expect top-line data from this study in the second half of next year and look forward to potentially exploring combination therapies of hep T-cell with direct acting antivirals. I am pleased that we have developed a pipeline that seeks to address such high-value and significantly underserved indications as obesity, NASH, and chronic hepatitis B. Our company's value has tremendous upside with these assets, and we look forward to advancing our programs through the clinic. With that, I will now turn the call over to Scott Harris to discuss our data and clinical plans. Scott?