Altimmune, Inc.

Greetings and welcome to the Altamune Inc. First Quarter 2021 Earnings Conference 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. Stacey Jurchison, Senior Director, Investor Relations and Corporate Communications for Altamune. Thank you, you may begin.

Thank you, Melissa, and good morning, everyone. Thank you for participating in Altamune's first quarter 2021 earnings conference call. Leading the call today will be Vipin Garg, our chief executive officer. Additional members of the Altamune team participating on the call today are Will Brown, our chief financial 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 first quarter 2021 financial results was issued this morning 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 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 SEC. I would also direct you to read the forward-looking statement disclaimer in our earnings 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, Monday, May 17th, 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 Altamian.

Thank you, Stacey, and good morning, everyone. We appreciate you joining us today for the discussion of our first quarter 2021 financial results and business update. We're trying a new format for our call this quarter and have a slight presentation accompanying our remarks. As Scott Roberts will review momentarily, we have impressive new preclinical data for our ad COVID vaccine candidate that we want to take you through. And the slides will be helpful visual aids. Our development efforts over the past year have set the stage for 2021 to be a data rich period for our company. And we now have multiple investigational candidates advancing in the clinic. For today's call, we want to focus on two of our most promising product candidates AdCOVID, and Alt-801. We anticipate reporting top-line data from each of these programs next month, with data from the Phase I AdCOVID program likely to read out first. As pioneers in intranasal vaccine development, we are especially proud of our achievements as they relate to our AdCOVID program. As an intranasal vaccine candidate, ADCOVID features unique attributes that are not available with currently authorized intramuscular vaccines. And therefore, we strongly believe that if authorized or approved, ADCOVID could become an important tool for the global COVID-19 vaccination effort. With the global pandemic continuing, there is widespread and growing awareness and interest in alternative vaccine approaches. for good reason. Although currently authorized vaccines have demonstrated excellent efficacy, there continues to be a considerable worldwide disparity in vaccine availability and increasing hesitancy around first-generation options. One of the key attributes I want to emphasize for ADCOVID is the potential for excellent tolerability, which is critical for maintaining a high degree of vaccine uptake. Based on experience with our influenza vaccine candidate, Nasovax, we believe that COVID will be extremely well tolerated and easier to administer, potentially even self-administered. In fact, clinical and preclinical studies with our platform vaccine technology have shown a tolerability profile virtually indistinguishable from placebo. So we are very encouraged about this attribute of our vaccine candidate. As a single-dose needle-free vaccine that is expected to be well-tolerated and thermostable, we believe that COVID has the potential to address many of the current shortcomings of the COVID-19 vaccination effort and offer an important option for use in special populations such as pediatrics and maternal immunization campaigns. Pending authorization, we anticipate ADCOVID finding wide acceptance as a booster for revaccination, including for coverage against variants of concerns and as a primary vaccine in the pediatric population and in developing countries based on its ease of intranasal administration and its expected stability profile. Accordingly, we are excited and cautiously optimistic about our upcoming phase one data readout, which we expect to announce in June. If the results of this trial are positive, we plan to quickly transition into a global phase two clinical development program, which Scott Harris will review in more detail momentarily. We are planning for success and in parallel with the development of our phase two program, we have taken steps to ensure our manufacturing readiness. During the quarter, we announced the expansion of our agreement with Lonza to include the construction of a dedicated manufacturing suite for AdCOVID, which will be capable of supplying product for late stage clinical trials and potential future commercial supply. Manufacturing constraints have been a significant hindrance in global COVID-19 vaccine production efforts, and we want to help ensure our ability to supply ad-COVID on a commercial scale if authorized for use. We are operating in an exceptionally dynamic environment as each new victory or setback in the COVID-19 vaccine space recasts the landscape. Consequently, we have had to be adaptable and prepare to alter our course as events and developments dictate. In this context, we anticipated growing challenges in recruiting subjects to a placebo-controlled study as the authorized vaccines have become more widely available. Therefore, we amended our ADCOVID phase one clinical trial protocol to reduce the number of subjects in this study to approximately 80 adults. I am pleased to report that we have now met the target enrollment in our amended phase one at COVID clinical trial and are on track to announce top line data in June. It's important to note that the size of our amended study is comparable to the numbers of participants in phase one studies of the U.S. authorized vaccine and is more than sufficient to demonstrate the anticipated robust tolerability, and immunogenicity of the vaccine. Should the data support moving forward, we anticipate commencing our proposed phase two development program quickly thereafter. Despite the availability of currently authorized vaccines, there is still significant need and opportunity for a differentiated vaccine candidate like AdCOVID that may offer unique attributes. From a public health perspective, the potential to block transmission is important. And for the individual, the nasal route of administration and anticipated tolerability of ad-COVID may also be very meaningful. Feedback from our key opinion leaders and the public suggests that the appeal of an intranasal vaccine remains strong. And we are optimistic about the future potential of our ad-COVID vaccine candidates to make a difference in the global vaccination effort. Before Scott Harris provides an update on the clinical program, I would like to turn the presentation over to our chief scientific officer, Scott Roberts, to take you through some of the exciting new preclinical data that we have recently generated in collaboration with our partners at UAB. The SARS-CoV-2 challenge model that we will be discussing is considered one of the best animal models for COVID-19 research, and we are particularly encouraged by the new data in this robust model. Scott, please go ahead.