Vaxart, Inc. (NASDAQ:VXRT) Q4 2023 Earnings Call Transcript
Vaxart, Inc. (NASDAQ:VXRT) Q4 2023 Earnings Call Transcript March 14, 2024
Vaxart, Inc. isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Greetings, and welcome to the Vaxart Business Update and Full Year 2023 Financial Results Conference Call. A question-and-answer session will follow management's opening remarks. Individual investors may submit written questions to ir@vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel.
Edward Berg: Good afternoon, and welcome to today's call. Joining us from Vaxart are Dr. Michael Finney, Interim Chief Executive Officer; Dr. Sean Tucker, SVP and Chief Scientific Officer; Dr. James Cummings, Chief Medical Officer; and Phil Lee, Chief Financial Officer. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations and its product development and regulatory progress, including statements about its ongoing or planned clinical trials. Actual results could differ materially from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process, and other risks described in the Risk Factors section of Vaxart's most recently filed Annual Report on Form 10-K and also on other periodic reports filed with the SEC.
Vaxart undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Dr. Michael Finney. Mike?
Michael Finney: Thanks, Ed, and thanks to all of you for joining us today. It's a pleasure to be speaking with you at this exciting time in the company's development. As this is my first quarterly call with you, I will begin with a brief introduction of myself and my observations of our company, and then I'll transition the call to the rest of the team to move through our recent accomplishments, clinical programs, upcoming planned milestones, and full year performance. First, this is my second installment as Vaxart's CEO, having served in a similar capacity from 2009 to 2011. I've been a Vaxart Board member since 2007 and Board Chair since March 2023. Throughout my time with Vaxart, I've seen the company go through many periods of clinical and corporate growth and take on a variety of new challenges.
Never have I been more confident in our team and in our trajectory than I am right now. I firmly believe 2023 was a transformational year for this company and our mucosal technology. We made solid progress on our oral vaccine platform, completing two Phase 2 clinical studies for our norovirus oral vaccine candidates, and we have now established proof of concept in two challenge studies for both respiratory and GI viruses. Based on the totality of the data we have produced through these and our other reported clinical trials, I think it's clear that what we have our hands on. Our oral pill vaccines hold a very real promise of offering several advantages compared with injectables, including the ability to vaccinate people faster, easier, and painlessly without the need for cold chain storage or trained medical professionals to administer the vaccine, as well as the promise of mucosal immune response.
We've already determined in preclinical and clinical trials that our candidates have a favorable immune profile, induce serum antibody and serum neutralizing antibody responses, induce potent T cell responses, create mucosal immune responses, and can inhibit virus shedding, which may have an impact on virus transmission. Looking at the current landscape, and particularly given our recent BARDA contract award, we are now poised to make a major stride forward with our COVID-19 program. James will go over the details of the preparation and the study design, but it's clear that the federal government believes we need better vaccines that harness the power of mucosal immunity to more strongly combat the current STD and future variants of the virus.
The first generation of vaccines was a start, but the viruses continue to evolve. We can do much better, and Vaxart is prepared to accept that challenge and demonstrate our technology's promise. At the same time, we're making steady progress on our norovirus program. We've completed our analyses of the recent challenge study data and have identified a potential correlate of protection, which will inform our upcoming meeting with the FDA to discuss the optimal path forward for this program. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development, and it's both formulated for oral administration and designed for delivery to the gastrointestinal. Norovirus carries a tremendous economic burden in this country and globally, and we look forward to creating an oral vaccine that eases this burden for millions of society's most vulnerable.
Finally, I can say with great pleasure that last week we announced the appointment of a permanent President and Chief Executive Officer, Steve Lo. Steve brings a wealth of biopharma experience to Vaxart, with more than 25 years in healthcare, biotech, and pharmaceuticals, including more than 12 of those years in the C-suite. He's had a particular focus on development and commercialization, having helped two companies bring their first product to market. Vaxart is in a tremendous position to advance its mission. We are excited to add a high-caliber experienced CEO to elevate this company to greater heights and create value for our shareholders. And currently, I will be stepping down as CEO and retaining my position as Chair of the Board. Steve joins Vaxart's effective March 18, and we are thrilled to welcome him.
I'll now turn over the call to James to review the recent progress for our coronavirus program.
James Cummings: Thanks, Mike. First, I want to thank our clinical, regulatory, CMC, and research teams who've worked tirelessly for nearly four years on our COVID-19 program. Their perseverance and dedication to our cutting-edge research have been crucial in laying the groundwork for this program's recent progress. All of us here at Vaxart were encouraged in January to receive a $9.27 million contract from BARDA to prepare for a 10,000-subject Phase 2b clinical trial evaluating our company's oral pill XBB COVID-19 vaccine candidate against an approved mRNA vaccine comparator. This award is part of the federal government's Project NextGen effort to boost our nation's pandemic preparedness and improve upon our collective ability to combat COVID-19.
Vaxart is one of only a handful of companies to receive funding from BARDA to date to prepare for a Phase 2b clinical trial under this very important initiative. We're heartened by the government's support, which we think is indicative of the potential of our differentiated approach to the continuing challenge that is COVID-19. This support will empower Vaxart to move forward with our oral COVID-19 program. Currently, we're engaged in preparations to initiate this Phase 2b trial. This trial, which may start as early as Q2 in 2024, is a Phase 2b, double-blinded, multi-center, randomized, comparator-controlled clinical trial to determine the relative efficacy, safety, and immunogenicity of Vaxart's investigational oral SARS-CoV-2 XBB vaccine tablet against a currently approved mRNA COVID-19 needle-injected booster vaccine in adults previously immunized against COVID-19 infection.
As we continue our clinical trial preparations, we're working to secure additional funding, which would support the initiation and conduct of the Phase 2b study. We will provide the timing and amount of any additional funding as events warrant. Commensurate with additional funding, we hope to be among the first of the Project NextGen recipients to initiate our Phase 2b head-to-head clinical trial. Last month, we continued to demonstrate the cross-protective potential of our COVID-19 vaccine candidates with the publication of previously announced data in the journal, Vaccines. This preclinical non-human primate data showed that our vaccine candidates could protect against multiple SARS-CoV-2 variants of concern as they elicited strong antigen-specific serum IGG and IGA responses with neutralizing activity.
Vaccination also reduced SARS-CoV-2 shedding following infectious challenge in both the upper and lower airway of non-human primates. Publications in highly respected journals such as Vaccines are really important because they continue to show that our groundbreaking research is being recognized by the scientific community. These data also serve as the foundation for our current COVID-19 vaccine candidates, which will be evaluated during the upcoming Phase 2b clinical trial. Vaxart's vast platform and technology has great potential. We believe this platform could transform the landscape not only for COVID-19 vaccines, but also for other infectious diseases that present significant threats to global public health, such as norovirus and influenza.
We're very proud of our entire team as we continue to lead the way in mucosal vaccine science. I'll now hand the call over to Dr. Sean Tucker, our Chief Science Officer and Founder, for an update on our norovirus vaccine program. Sean?
Sean Tucker: Thanks, James. We made significant progress in our norovirus program in 2023, delivering top-line data from two Phase 2 studies, including a challenge study of our G11 monovalent candidate. We have evaluated most of the data, and we believe we are on track for identifying potential correlates of protection that will aid in the advancement of our bivalent norovirus candidate. We believe the data we have shared to date is promising for this vaccine candidate and for our vaccine platform overall. Late in the fourth quarter, we completed enrollment in our Phase 1 clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in lactating mothers' breast milk and transfer those antibodies to young infants.
Recall that this study is being supported partially by the Bill and Melinda Gates Foundation. This Phase 1 multicenter, randomized, double-blind, placebo-controlled, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of our oral-administered bivalent G11, G24 vaccine in healthy lactating females of at least 18 years of age. The study enrolled 76 subjects at five sites in South Africa. These subjects were randomized into high- or low-dose vaccine or placebo. The primary endpoints to the study is frequency, duration, and severity of solicited symptoms for one week following the study drug dose, the frequency, duration, and severity of unsolicited treatment adverse events, serious adverse events, adverse events of special interest, and new onset of clinical illness through the active period.
In particular, and what's most exciting, is that this study will look for VP1-specific IgG1 and IgG4 IgA in the serum and in the breast milk. We are currently expecting to announce top-line results from this Phase 1 trial in mid-2024. Going forward, we plan to meet with the FDA during the second quarter of 2024 to discuss our data on potential correlates, a Phase 2b dose confirmation study, and potentially a G24 challenge study. We currently believe a Phase 2b study would generate sufficient safety data to have an end-of-Phase 2 meeting with the FDA. An end-of-Phase 2 meeting would allow us to gain concurrence with the FDA on the scope and design of a Phase 3 pivotal efficacy study in adults over 18 years of age. That said, the type and timing of our next clinical study will be determined following our meeting with the FDA in Q2.
We plan to provide an update on the next steps for this program as soon as we are able to after that meeting. I'll now hand the call over to Phil Lee, our CFO, for a brief discussion of our financials. Phil?
Phil Lee: Thank you, Sean. The details of our financial results for the full year 2023 are summarized in today's press release. Revenue for 2023 was $7.4 million, compared to $0.1 million in 2022. Revenue in 2023 was primarily from revenue recognized for work performed under Vaxart's grant from the Bill & Melinda Gates Foundation, and non-cash royalty revenue from increased sales of Inavir in Japan. Vaxart ended 2023 with cash, cash equivalents, and investment of $39.7 million. This cash balance does not include approximately $15 million in net proceeds raised in early 2024. Vaxart anticipates current cash runway into the fourth quarter of 2024. Thank you all for your time today. We will now open the call for your questions.
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