Vaxart, Inc. (NASDAQ:VXRT) Q3 2023 Earnings Call Transcript November 2, 2023
Vaxart, Inc. beats earnings expectations. Reported EPS is $-0.11, expectations were $-0.18.
Operator: Greetings, and welcome to the Vaxart Business Update and Third Quarter 2023 Financial Results Conference Call. A question-and-answer session will follow management's opening remarks. Individual investors may submit written questions to email@example.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. Please go ahead, Ed.
Edward Berg: Good afternoon, and welcome to today's call. Joining us from Vaxart are Andrei Floroiu, Chief Executive Officer; Dr. James Cummings, Chief Medical Officer; Philip Lee, Chief Financial Officer; and Brant Biehn, Senior Vice-President for Business Operations. 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 materially differ 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 Andrei Floroiu. Andrei?
Andrei Floroiu: Thank you, Ed, and thank you to all of you for joining us today. On today's call, we will highlight the recent clinical progress we have made on our norovirus oral pill vaccine program. We'll also provide a look at our planned milestones and briefly discuss our COVID program before opening the call to your questions. During the third quarter, we took important steps to validate our mucosal vaccine platform. We released encouraging top-line data from two phase 2 trials of our norovirus program. First, from our phase 2 dose ranging study for our bivalent norovirus oral vaccine candidate. And then from our Phase 2 norovirus challenge study. The data we generated from both of these trials will drive the next steps for this program, which we believe has the potential to transform both how we think of norovirus and the vaccination paradigm as we know.
James will go over the scientific findings from these trials in more detail. But beforehand there are a few key points I'd like to share in terms of what we have learned at this stage of our norovirus program. First, our oral pill vaccine candidate has the potential to reduce the rates of norovirus infection, acute gastroenteritis, and virus shedding. These were key results from our recent challenge study. We believe that when we substantially reduce shedding, we dramatically slow down the rate of transmission. That is an incredible potential benefit of the vaccines. Second, we believe this data validate the potential of our oral tablet norovirus vaccine program We now have completed eight clinical trials for norovirus, all of which told that our vaccines induce strong immune responses and are safe and well-tolerated, with no vaccine-related serious adverse events.
We are confident in Vaxart’s platform and our norovirus program specifically as we aim towards a registrational Phase 3 study. And third, we believe we have established clinical proof-of-concepts for our oral pill platform via now two human challenge studies. One for norovirus and the other for influenza. In each case, we demonstrated that our oral pill vaccine technology has a clear and consistent impact on a number of important metrics such as reducing the rate of infection, illness and shedding. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system. A pill vaccine could truly change how we vaccinate globally, how we make vaccines, how we distribute them and how we administer them.
Not to mention the also that many more people who take vaccines that are not middle-based, while the more remote regions of the world could have access on oral pill that doesn't have the core change and infrastructure requirements of injectables. I want to emphasize the impact of the disease we are fighting against. Norovirus recently was named the leading cause of foodborne iron illness during the Joint Food and Agriculture Organization, and the World Health Organization Expert Meeting on, Microbiological Risk Assessment in Rome, Italy. And norovirus is the leading cause of gastroenteritis. This is a disease with an economic burden in excess of $10 billion annually in the US alone and of over $60 billion globally. Norovirus infections affect young children and the elderly disproportionately.
Recently, we dosed the first subjects in our previously announced clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in breast milk and transfer of antibiotics to young infants. We are excited about the potential for this study as Vaxart’s oral norovirus vaccine pills may make it possible for mothers to protect their infants against this highly contagious disease that has serious health consequences. And now for a brief update on our COVID-19 program. We continue to make progress on a potential COVID vaccine and we believe the cross-reactivity of our current construct suggests a pathway for developing a pan-coronavirus vaccine. Several recent forecasts project new COVID variance to continue to appear exacerbated the persistence of the serious threat to public health.
Given our prioritization of the norovirus program we are assessing next steps for the COVID program, which could include a number of options. We look forward to providing information once we determine the path forward for this important program. I’ll now turn the corner over to James to review the recent progress for our norovirus program.
James Cummings: Thanks. Andrei. We made great clinical strides in our norovirus program during the third quarter announcing top-line data from two separate Phase 2 trials. We believe the data that we've shared today is promising for this vaccine candidate and for our vaccine platform overall. I’d now like to provide you with a high level summary of both studies. First, I'll start with the data from our Phase 2 dose ranging study of our bivalent norovirus vaccine candidate. Recall that this candidate contains two genotypes, G11 and G24, both of which have caused the majority of norovirus disease in humans over the past 20 or so years. The primary endpoints are safety and immunogenicity in order to determine a dose level for our Phase 3 development.
The preliminary results of the trial showed robust serum immune responses across all doses at day 29 relative to day one. Both vaccine doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms. At day 29, increases in serum IGA, serum IGG, and BT50 for both the G24 and G11 strains in the vaccine arms were similar to those seen in previous norovirus studies conducted by Vaxart. These results also demonstrate that the bivalent norovirus vaccine candidate was well tolerated with a favorable safety profile that included no vaccine-related serious adverse events or SAEs and no dose limiting toxicity. Adverse event rates for both doses were similar to placebo. Turning to the Phase2 G11 norovirus challenge study, which measure the safety and immuonogenicity and efficacy of our monovalent norovirus vaccine candidate.
The primary objectives were to determine the clinical efficacy of our monovalent vaccine candidates, compared to placebo. To protect against norovirus acute, gastroenteritis or AGE caused by the Norwalk strain challenge inoculums. And to evaluate the VP1 specific IGA antibody secreting cells, or ASCs, the HVGA blocking antibody and the VP1 specific serum IGA and serum IGG responses to the vaccine. This was a double blinded, randomized, placebo controlled study, in which healthy volunteers received a single oral dose of our norovirus vaccine candidate that targets the G11 strain of norovirus or they received placebo on day one. On days 29, and 30, participants were challenged with the G11 strain of norovirus and then assessed for infection norovirus AGE and the immune responses through day 57.
This study met five of its six primary endpoints. The results show a statistically significant 29% relative reduction in infection. A 21% relative reduction in norovirus AGE that was not statistically significant and an 85% relative reduction in viral shedding, which was a pre-specified study endpoint in the vaccinated cohort, compared with placebo. As we noted in the data announcement, we believe these results support the potential for our norovirus vaccine program to provide significant public health benefits. We also believe these are important findings that support the potential use of our oral pill vaccine technology and enabling a vaccine for norovirus. As Andrei mentioned, we dosed the first subject in our Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovrirus vaccine candidate, focused on safety and immunogenicity in lactating mothers.
This is an important step towards Vaxart’s goals of developing a vaccine that may reduce the significant global health threat norovirus poses, especially to children under five years of age. Norovirus sickens approximately 21 million people in the United States each year and 15% of children under age five contract norovirus annually. We believe an oral pill norovirus vaccine may make it possible for mothers to protect their infants against this highly contagious virus. In terms of next steps for the norovirus program, additional analyses of the data from our previous norovirus trials are ongoing and these will help us in determining how we go forward. Next steps for registration would include a Phase 2b dose confirmation study of our bivalent candidate in order to obtain sufficient safety data to inform an end of phase 2 meeting with the FDA in the United States.
We remain on track for the FDA meeting by the end of 2024. I'll now hang the call over to Phil Lee, our Chief Financial Officer for a brief discussion of our financials. Over to you, Phil.
Phil Lee: Thank you, James. The details of our financial results for the third quarter of 2023 are summarized in today's press release. Revenue for the third quarter of 2023 was $2.1 million, compared to no revenue in the third quarter of 2022. Revenue in the third quarter of 2023 was primarily from revenue recognized for works performed under Vaxart’s grant from the Bill and Melinda Gates Foundation. Vaxart ended the third quarter of 2023 with cash, cash equivalents restricted cash and marketable securities of $53 million, compared to $67.9 million as of June 30th 2023. The decrease was primarily due to cash used in operations as we advanced our programs. The company continues to anticipate current cash runway into the third quarter of 2024. Thank you all for your time today. We will now open the call for your questions.
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