8/12/2020

speaker
Melissa
Conference Operator

Greetings and welcome to the Altamune, Inc. second quarter 2020 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ms. Monique Cossie, and best relations for Altamune. You may begin.

speaker
Monique Cossie
Investor Relations

Thank you, Melissa, and thank you, everyone, for participating in today's Q2 2020 Earnings Conference Call. Leading the call today will be Dr. Beth Engard, Chief Executive Officer of Altenew. Also participating on the call today is Will Brown, Chief Financial Officer, Scott Roberts, Chief Scientific Officer, and Scott Harris, Chief Medical Officer. After the prepared remarks, we will open up the call for a question and answer session. A press release with the Q2 2020 financial results was issued last night and can be found on the investor's page 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 the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All to mean cautions that these forward-looking statements are subject to risk 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 violence with the Securities and Exchange Commission. I would also direct you to read the forward-looking statement 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, Wednesday, August 12, 2020. And the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after or on today's date. As a reminder, this conference call is being recorded and will be available for audio rebroadcast on Altamune's website on www.altamune.com. With that, I will now turn the call over to Vipin Garg, Chief Executive Officer of Altamune. Vipin, please go ahead.

speaker
Vipin Garg
Chief Executive Officer

Thank you, Monique. Good morning, everyone, and thank you for joining us as we discuss our Q2 2020 Financial Results and Corporate Update. Joining me on the call today is Bill Brown, our Chief Financial Officer, who will review our Q2 financial results, as well as Scott Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer. After our discussion, we will open the call for Q&A. The first half of 2020 has been transformational for Altamune. and I'm very pleased with our progress to date. We have made significant strides towards developing two product candidates to address the COVID-19 pandemic. A highly differentiated intranasal vaccine and a novel immunomodulatory therapeutic candidate. We secured additional government funding and capitalized the company sufficiently to fully lean into the challenges that lie ahead of us. Outside of COVID-19, we continue to push forward aggressively on our other product candidates. We have recently completed enrollment in our NasoShield anthrax vaccine trial, and we are on track to begin an ALT801 first in human NASH trial in Q4. We also had a successful IND submission for our chronic hepatitis B therapeutic hep T cell, that is slated for a phase two trial to begin later this year. With these advancements, we are well poised to deliver shareholder value throughout 2020 and beyond. With that backdrop, I would like to spend a few minutes on our areas of focus for the remainder of this year. First, we are focused on expeditiously moving at COVID towards an IND and a phase one clinical trial in Q4. We look forward to building on ADCOVID's outstanding preclinical data by moving it into the clinic as quickly and safely as possible. We are pleased with robust mucosal and systemic immunity observed in preclinical studies conducted by our collaborators at the University of Alabama at Birmingham. We have simultaneously forged alliances with several manufacturing partners to secure clinical trial material and began that process in July. As Scott Roberts, our CSO, will discuss momentarily, these activities are going well and we remain on track to begin our phase one clinical trial later this year. Second, We continue to pursue non-dilutive funding for AdCOVID. As previously announced, we entered into a teaming agreement with Dynaport Vaccine Company, or DVC, to pursue federal and nonprofit funding. DVC, a general dynamics information technology company, has extensive experience in vaccine development and has been the prime contractor and systems integrators for many government projects. The partnership with DVC significantly expands Altimmune's capabilities to execute on government funding opportunities and accelerate the development of AddCOVID. Third, we remain focused on executing the TCOVID trial and maintaining DoD support. During the second quarter, we announced not only that we had created a new program based on RespireVac, our replication-deficient adenovirus 5 platform, but that the Department of Defense awarded Altimmune $4.7 million to fund the EPIC trial, our Phase 1-2 clinical trial of T-COVID. in the prevention of clinical worsening in COVID-19. We are especially excited about this program as it represents a novel mechanism with tremendous promise. And we are one of the few therapeutics intended to stop the progression of early COVID-19 to severe disease and hospitalization. We are working very closely with our colleagues at the U.S. Army Medical Research and Development Command on this program. and then Scott Harris, our CMO, will more fully discuss. We look forward to enrolling our first patient imminently and delivering top-line data readout from this trial in Q4 of this year. I would now like to turn the call over to Scott Roberts, our CSO, who will fully update you on the progress we have made with AdCOVID. And then Scott Harris, who will discuss our clinical plans across our portfolio. Scot Roberts.

Disclaimer

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