Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to the Altamune Incorporated Q2 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, key on your touch-tone telephone. As a reminder, this call may be recorded. I would now like to introduce your host for today's conference, Will Brown, Chief Financial Officer of Altamune. Well, you may begin.

Thank you, operator, and good morning, everyone. Thank you for participating in Altamune's second quarter 2021 earnings conference call. Leading the call today will be Vipin Garg, our chief executive officer. I will also be presenting during the call, as well as 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 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 risks and uncertainty 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 a discussion of some of these 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, August the 11th, 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 Altamine's website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altamine.

Dr. Thank you, Will, and good morning, everyone. We appreciate you joining us today for a discussion of our second quarter 2021 financial results and business update. I want to begin today's call by thanking our employees, our collaborators, and our investors for the tremendous dedication and support they have shown to Altimmune over the last 18 months. In January 2020, upon studying emerging reports of the devastating COVID-19 virus, our R&D team sprang into action in our labs and began creating a COVID-19 vaccine based on our intranasal platform technology. Our encouraging data with our Phase II clinical trials with NasoVax gave us confidence that an intranasal vaccine could be effective in protecting individuals against this new respiratory virus. Through the most uncertain days of the pandemic and quarantine, our employees and collaborators answered the call to this global crisis through extreme dedication to the task at hand that came with tremendous personal sacrifice of time with family and loved ones. I was proud and inspired by their resiliency and resolve. Through this work, our confidence was bolstered that ADCOVID could have great potential as a mucosal vaccine as we gathered positive animal data, including a potent induction of local mucosal and systemic immune responses and demonstrated efficacy against the SARS-CoV-2 virus. However, far too many times in our business, we see product candidates that work extremely well in animals, but do not translate to humans. And unfortunately, that was our experience. We were extremely disappointed at the phase one at COVID data, and we had to take an honest look at the viability of performing continued experiments and clinical tests at a time when the mRNA and other vaccine approaches were working so very well. And during an efficient vaccine rollout and update rate by the general public, that will surely stand as a remarkable achievement in the history of vaccine development. We applaud the efforts of the global pharmaceutical community in swiftly developing these new vaccines. With this backdrop of success and always seeking to be good stewards of the resources entrusted to us, we made the swift decision to terminate the AdCOVID program. As you have heard us say many times, one of the central tenets of our philosophy is to maintain and develop a diversified portfolio of assets to ensure that we are positioned for success no matter what transpires with any one of our product candidates. That philosophy has served us well in 2021 with the clinical development of Alt-801, our GLP-1 glucagon dual agonist for the treatment of obesity and NASH. As Scott Harris will more fully describe, we saw significant weight loss in just six weeks in our phase one study with no serious GI side effects. This fuels our enthusiasm and excitement for Alt-801, especially in light of the recent successful commercial launch of semaglutide for the treatment of obesity. It's further encouraging to compare our six-week interim results against other Phase I clinical trials with similar agents. noting that we are at the top of the class in terms of weight loss and tolerability at six weeks, and without the need for dose titration. With this data, we gained the confidence to launch an additional program with Alt-801 in obesity, and we expect to file an IND in the fourth quarter to enable a phase two trial in obesity, which will follow our previously announced IND for NASH in the third quarter. For the remainder of 2021, we look ahead to our phase one Alt-801 12-week data from Australia, which we anticipate reporting in September. Following this trial are several studies to further explore the effects of our drug in NAFLD and diabetic subjects, along with a study to test the interaction of Alt-801 with drugs commonly administered to obese and diabetic subjects. These studies will enable meaningful Phase II trials in both NASH and obesity, with large studies planned to begin in early 2022. Our other asset within the liver space is Hepticel, an immunotherapeutic for chronic hepatitis B that is in Phase II development. We have in Hepticel one of the most clinically advanced immunotherapeutic candidates, and we are in the midst of executing on this international trial. We currently have sites in Canada, US, Germany, and Spain to follow patients in a six-month dosing regimen. Considering the time to enroll HPV patients in this COVID environment and the duration of dosing, we expect to have data in the second half of next year. So in Q3 2021, We now turn the page to the next chapter of Altruism, with our focus firmly on obesity, NASH, and chronic hepatitis B, with exciting drug candidates and an enviable cash position with which we can quickly advance through several near-term data catalysts. With that, I'll now turn the call over to Scott Harris to discuss our six-week data, the upcoming 12-week data readout, and subsequent advanced trials. Scott.