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Altimmune, Inc.
11/10/2020
Thank you. so so Good morning and welcome to the Altimmune Inc. Third Quarter 2020 Earnings Conference Call. All participants will be in listening mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. I would now like to turn the conference over to Stacey Jurchison. Please go ahead.
Thank you, Operator, and thank you, everyone, for participating in Altamuse Third Quarter 2020 Earnings Conference Call. Leading the call today will be Vipin Garg, Chief Executive Officer of Altamune. Other members of the Altamune Executive Team participating on the call today are Will Brown, Chief Financial Officer, Scott Roberts, Chief Scientific Officer, and Scott Harris, Chief Medical Officer. After the prepared remarks, we will hold a question and answer session. A press release with our third quarter 2020 financial results was issued last night and can be found on the IR section of our 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. Altenew 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 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 Securities and Exchange Commission. I would also direct you to read the forward-looking statements disclaimer in our earnings release issued last night and now available on our website. Any statements made on this conference call speak only as of today's date, Tuesday, November 10th, 2020, 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 rebroadcast on Altimmune's website at www.altimmune.com. With that, I will now turn the call over to Dr. Zipan Garg, Chief Executive Officer of Altimmune. Zipan, please go ahead.
Thank you, Stacey. and good morning. We appreciate you joining us today for a review of our third quarter 2020 financial results and business update. As Stacey mentioned, joining me on the call today are Bill Brown, our Chief Financial Officer, Scott Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer. After our prepared remarks, we will hold a Q&A session. 2020 continues to be a transformational year for Altimmune and our shareholders. In particular, the third quarter has been an exceptionally busy time as we progress five novel investigational candidates in clinical development. Never in our history have we had so much opportunity to build value and so many promising shots on goal that are advancing towards clear inflection points over the next six to 12 months. I'm especially proud of our accomplishments as they relate to our COVID-19 candidates. As we have achieved so much in a compressed timeframe. At the outset of the year, as the pandemic swept around the globe, we rapidly mobilized our expertise to develop a new and promising intranasal vaccine candidate at COVID. that we believe has the potential to combat this global crisis. We also initiated the development of a promising therapeutic, intranasal therapeutic T-COVID. These product candidates are uniquely differentiated and offer significant advantages compared to other therapeutic and vaccine approaches, positioning Altimmune solidly as a significant player in the COVID-19 arena. During the third quarter, we made important strides advancing each of these candidates. We continued preparations to initiate a phase one study of ASCOVID, which is on track to commence this quarter with a data readout expected in Q1 2021. And we initiated the phase one slash two EPIC clinical study of TCOVID. With the support of our collaborators, at the University of Alabama at Birmingham, we presented new and compelling preclinical data for ADCOVID, showing that ADCOVID can provide potent stimulation of antigen-specific CD4 and CD8 T-cells that reside in the lungs, as well as a 29-fold mucosal IgA antibody response against the virus in the respiratory tract. Importantly, these unique respiratory tract focused immune responses are in addition to the strong serum neutralizing antibody response we measure. Finally, we advance plans to scale up our clinical and commercial manufacturing capacity for ADCOVID through the execution of agreements with multiple commercial manufacturing partners to help ensure our commercial readiness. This morning, we announced an agreement with Lonza to further strengthen our commercial readiness. In conjunction with these activities, we have maintained an active dialogue with policymakers in Washington, D.C., working diligently to raise awareness of the advantages of our intranasal vaccine approach. The announcement yesterday of preliminary data from the Pfizer vaccine trial is exciting. and offers promise for an effective vaccine for COVID-19. As our CSO, Dr. Scott Roberts, will describe shortly, we believe that ADCOVID offers some very unique attributes that are not being fulfilled by the first generation of vaccine candidates. We believe that if the phase one data confirm the promising preclinical results we have observed, ADCOVID could play an important role in the world's COVID-19 vaccine armamentarium. Aside from our COVID-19 programs, we have a broad and deep pipeline of promising intranasal vaccines and peptide therapeutics, including NasoShield, Alt-801, and Hep T-cell, each of which also made important progress in the third quarter. Specifically during the quarter, we completed enrollment in a Phase 1B clinical trial of NasoShield anthrax vaccine, and we anticipate a readout from that trial towards the end of this year. Alt-801 also continues to advance towards the clinic, and we are on track to begin a Phase 1 study of Alt-801 for the treatment of NASH later this quarter. Similarly, We completed preparations to commence a phase two study of hep T cell, also scheduled to begin before the year end. As you can see, we have significant momentum developing as each of these clinical trials get underway, and a catalyst-rich period lies ahead of Altimmune and our shareholders. We expect multiple data readout over the coming months. Importantly, we are well-capitalized to advance each of our programs towards these meaningful inflection points. Looking ahead, I'm very excited about the future potential for our company and pipeline candidates. I look forward to keeping you updated on our progress. I would now like to turn the call over to Scott Roberts to provide an update on our progress related to AdCOVID. And then Scott Harris, our Chief Medical Officer, who will provide a clinical update across our portfolio.
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