Earnings Call Transcript - VXRT Q2 2022

Operator, Operator

Greetings, and welcome to Vaxart's Second Quarter 2022 Business Update and Financial Results Conference Call. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Brant Biehn, Senior Vice President, Business Operations.

Brant Biehn, Senior Vice President, Business Operations

Good afternoon, and welcome to today's call. Joining us from Vaxart are Andrei Floroiu, our Chief Executive Officer; Dr. Sean Tucker, our Founder and Chief Scientific Officer; and Dr. James Cummings, our Chief Medical Officer. Before we get started, 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, the extent and duration of the impact of the COVID-19 pandemic, and other risks described in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after this call, except as required by law. I'll now turn the call over to Andrei Floroiu. Andrei?

Andrei Floroiu, CEO

Thank you, Brant, and thank you, everyone, for joining us today. As discussed during our call on June 22, Vaxart is committed to providing our investors with more frequent communication, and we are pleased to have this opportunity to review our recent progress and outline our upcoming milestones. This is, in fact, Vaxart's first quarterly call in many years, and it couldn't have happened at a better time. Our mission here at Vaxart is to realize the full potential of our oral pill vaccine class, which we believe has the potential to revolutionize vaccines as well as how we vaccinate around the world. Vaxart's vision is that of a world where oral tablet vaccines are a reality, allowing more people to be vaccinated easily and painlessly with just a glass of water, a world where oral tablet vaccines provide superior protection by harnessing the power of mucosal immunity. While oral tablet vaccines could offer tremendous benefits across the full spectrum of targeted applications, they could have a particularly significant improvement over injected vaccines during pandemics. Indeed, we believe that our oral tablet vaccines could revolutionize how we fight the current COVID-19 pandemic as well as future ones. It is this immense potential that drives us here at Vaxart. Equally important, this vision has been generating impressive enthusiasm among our shareholders, and we would like to thank them for making Vaxart special and validating our purpose. We are very excited to be talking to you today. As I mentioned in our June 2022 investor webcast, I believe that Vaxart today is in the best position it has been in its entire 15-year existence after undergoing a significant transformation over the past two years that has allowed us to internalize key capabilities and strengthen our human capital, from the labs to the GMP suites to the management team. What this means is that Vaxart is now in the best position it has ever been to leverage the potential of our oral vaccine platform by progressing multiple programs in parallel. This is happening at a time when the need for better next-generation vaccines could not be clearer. The COVID-19 pandemic in general and the Omicron variants in particular have exposed significant shortcomings in traditional vaccines. Now, Monkeypox is reminding us that COVID-19 is unlikely to be the last pandemic we see in our lifetime. The potential advantages of oral pill vaccines are significant, particularly in pandemics. More people will get vaccinated by oral pill vaccines, and mass vaccination with an oral pill could potentially be done much faster than with a needle. Furthermore, as my colleagues Dr. Tucker and Dr. Cummings will cover in more detail, the potential advantages of our vaccines go well beyond the oral pill format. By triggering mucosal immunity, our vaccines have the potential to offer broader protection against a wider array of variants and pathogens, to provide longer-term protection, and to reduce transmission. Now let me discuss two key clinical programs, COVID-19 and norovirus. One challenge of developing a COVID-19 vaccine is doing so against a virus that continues to evolve, basically a moving target. We started developing our COVID-19 vaccine in a world that was dealing with just one strain. As more strains started to appear, we became more confident that our oral tablet vaccine candidate would offer superior protection due to the cross-reactivity of mucosal immunity and the powerful T-cell responses. We now believe that the best way to leverage this distinctive cross-reactivity is to aim for solutions with future-proof potential by expanding our portfolio to include constructs that target the new Omicron variants of concern, BA.4 and BA.5, and to study these as both monovalent and bivalent constructs. Doing so could provide multiple clinical and strategic advantages. It positions us better for our human Omicron challenge study in the U.K., which is the first such study announced worldwide. It positions us better relative to our needle-based competitors as everyone has only recently started to work on the BA.4/5 variants. It fits the recommendations and expectations of regulators such as the FDA, which recently approved boosters for the targeted BA.4/5 variant. Therefore, we are very excited about the prospects of our enhanced portfolio, which my colleagues will cover in more detail regarding its future-proof potential. Now let me turn to our other lead clinical program. During this quarter, we made progress with our norovirus program by adding clinical evidence that continues to excite us about the prospects of this program. The recent data from our trial in elderly adults is very encouraging as it suggests similar activity as in younger adults. This is not often the case with injected vaccines, providing another potential source of differentiation for our oral fill vaccine candidate and increasing our confidence as we continue our development. Now I'll hand the call over to Dr. Sean Tucker to review the multiple advantages that our oral vaccine technology offers. Sean?

Sean Tucker, Chief Scientific Officer

Thanks, Andrei. First, I'd like to remind the listeners that we have already reported on multiple data sets demonstrating clearly that we can generate a robust mucosal IgA response. These responses could have the potential to provide superior protection at anatomical sites where infections actually enter the body, such as the respiratory and intestinal systems. This benefit is not observed with injected vaccines, which primarily create a blood-based serum response. There's a growing body of data supporting our belief that mucosal vaccines can provide robust protection against a variety of infectious diseases. The COVID pandemic has revealed challenges associated with mass vaccination campaigns using injected vaccines, which require managing cold and ultra-cold chains. These challenges have limited the development of potentially life-saving vaccines in low-income countries and rural areas, even within middle- and high-income countries. Injected vaccines also necessitate that people travel to vaccination sites, further complicating vaccine access. In contrast, our vaccines are room temperature stable and offered in an oral format. This simplifies mass vaccination campaigns by enabling potential self-administration at home without special equipment or trained personnel, removing the need to schedule and travel for appointments. Furthermore, our technology significantly reduces medical waste, which has been an environmental and economic challenge throughout the COVID-19 pandemic. Finally, vaccines only work when patients actually get the vaccine, and our oral vaccine may overcome some vaccine hesitancy among individuals who dislike injections, potentially increasing the number of people protected. Over the past several months, we've reported multiple data sets supporting the significant potential of our COVID-19 vaccine candidate to address the challenges posed by an evolving virus. Recently, we published data in a preclinical hamster study conducted by researchers at Duke University, demonstrating that our S-only COVID-19 vaccine candidate could reduce disease and airborne transmission. We've also shown preclinical data indicating that two of our vaccine candidates targeted at the SARS-CoV-2 S protein for Wuhan and the S protein for Omicron could protect hamsters when challenged with the Omicron-BA.1 variant. Additionally, we have preclinical data suggesting that administering the S-only or the S+N COVID-19 vaccine candidate to the mucosa of non-human primates resulted in significant increases in serum IgG and IgA, with up to a 1,000-fold increase in nasal IgA responses against SARS-CoV-2. Importantly, all vaccinated animals challenged with SARS-CoV-2 Beta strain, a more recent variant, exhibited significant reductions in viral titers in the nasal passages compared to unvaccinated controls. This case holds even if the vaccines were developed against other viral strains such as Wuhan. Beyond the growing body of robust data demonstrating the efficacy and safety of our vaccine candidates, we are taking important steps to accelerate clinical development. Clearly, we and others believe that mucosal vaccine technology holds great promise, and we are committed to turning that promise into solutions addressing important public health challenges and creating value for our investors. I'll now turn the call over to James Cummings, who will review recent enhancements, next steps, and upcoming milestones for our COVID and norovirus vaccine candidates.

James Cummings, Chief Medical Officer

Thanks, Sean. I'll begin with our COVID-19 clinical vaccine program. Updated data from the Phase I trial of our S+N candidate showed that this candidate stimulates SARS-CoV-2-specific IgA antibodies in saliva and in nasal samples from human subjects, and it was cross-reactive to many different coronaviruses, including the circulating variants of SARS-CoV-2. We believe that this broad cross-reactivity is an important differentiator for Vaxart given the continuous evolution of novel virus strains that escape immunity from currently approved needle-based vaccines. Last month, we announced an agreement with hVIVO Services, a subsidiary of Open Orphan. Under this agreement, hVIVO will conduct a characterization study and successfully develop a human challenge model based on the Omicron variant of SARS-CoV-2, with the intention of conducting a subsequent Phase II human challenge trial for our COVID-19 vaccine pill candidate. In terms of next steps, we have several important near-term milestones in our COVID-19 vaccine development program. First, we're on track to report preliminary data from the Phase II COVID-19 clinical study Part 1 in the third quarter of this year. Second, we intend to decide on advancing either our S-only or S+N candidate to a Phase II/III trial in H1 of 2023. As a science-based and data-driven company, we're committed to following the emerging science as novel viral variants continue to evolve. In selecting a candidate to advance to the next clinical stage of development, we'll consider results from the ongoing Phase II trial of our S-only candidate and the longevity data from the S+N candidate. Also, as Andrei mentioned, based on recent FDA guidance, we're evaluating both Wuhan and Omicron-based vaccine candidates to determine the best approach to provide maximum protection against currently circulating strains as well as strains likely to evolve in the future. Everyone at Vaxart is determined to have a candidate with a high likelihood of success once we enter Phase III and the potential to provide benefits to people around the globe and to our investors. We also continue to work with the Indian government to initiate a Phase Ib trial in India. As we discussed last month during our call, we've approached regulatory authorities in India regarding our COVID-19 study as both a booster for individuals previously immunized and as primary vaccination in vaccine-naive populations if possible, and it's been very well received. However, the Indian regulatory pathway does take time. Additionally, our vaccine and platform are novel compared to the injected needle-based vaccines available, so testing of our product by Indian regulatory authorities requires enhanced capabilities on their part to evaluate our vaccine candidate, and we've been very responsive to their questions. We're looking forward to embarking on our study in India once regulatory review is completed. We intend to refine that study based on data from Part 1 of our Phase II COVID-19 study conducted here in the United States. Now let me pivot to our recent progress and next steps in our norovirus program. In June, we reported positive preliminary data from a Phase Ib trial of our norovirus vaccine candidate in subjects aged 55 to 80 years, which showed stimulation of robust immune responses across all doses with a dose-dependent production of IgA antibody-secreting cells. Notably, these results were consistent with previous studies conducted in younger populations, which is usually not the case as the immune system generally weakens with age, leading older individuals to have a less robust response to vaccination compared to younger people. We're very excited about these findings because they demonstrate the power of our vaccine technology platform. Adults over the age of 55 years are generally more vulnerable to norovirus infection, with 7.5% of this population infected annually. Data generated to date suggests that our norovirus vaccine has the potential to offer protection against norovirus across a wide age group. Building on the promise of data generated in our norovirus program, we expect to initiate a Phase II trial of a bivalent norovirus vaccine later this year. This vaccine would include two norovirus proteins, G1.1 and G2.4, which are responsible for most of the norovirus outbreaks globally, potentially stimulating even more robust immune responses than we observed in our monovalent candidate. We expect to report preliminary data from the ongoing Phase II norovirus challenge study towards the end of the first quarter of 2023 or the beginning of Q2. Before I turn the call back to Andrei, I'd like to express my pride in the work our team has accomplished, especially in light of the challenges many have faced while operating in an ongoing global pandemic and global supply chain challenges. I'd like to thank everyone at Vaxart, our academic and clinical collaborators, and our volunteers participating in our clinical studies for their contributions to helping us realize our vision of transforming the vaccine landscape. I would also like to thank our investors; you've put your trust in us, and we will get the job done. Back to you, Andrei.

Andrei Floroiu, CEO

Thank you, James. Before we move on to the Q&A session, let me say a few words about our cash position and upcoming milestones. We have a strong financial position with $131 million in cash and cash equivalents as of June 30, 2022. This provides us with runway until the second half of next year, 2023. Let me share highlights of the important milestones we expect over the next 12 months or so. Top-line data from the Phase IIa COVID-19 clinical study is expected in the third quarter of this year, 2022. Selection of the COVID-19 vaccine construct is expected in Q4 of this year, with clinical trials to start in the first half of next year. We will update plans for our India trials after determining which COVID-19 vaccine candidate to advance. Then the start of the Phase II trial of Vaxart's bivalent norovirus vaccine candidate is expected in Q4 of this year. After that, top-line data from our ongoing Phase II norovirus study is expected at the end of the first quarter or early in the second quarter of 2023. Finally, the Omicron human challenge trial in the U.K. is expected to start in the second half of 2023, using the selected COVID-19 vaccine construct. Many important developments are expected over the next year to 1.5 years, including important value inflection points. We are thus very excited to continue to work hard toward unlocking the full potential and value of our unique oral pill vaccine platform. I want to thank everyone who has joined us for our call today and especially our investors who continue to support our mission. We'll now begin the Q&A portion of the call.

Operator, Operator

Our first question comes from Charles Duncan with Cantor Fitzgerald.

Pete Stavropoulos, Analyst

This is Pete Stavropoulos for Charles. Andrei and team, congratulations on all the forward movement. I have a couple of questions. In terms of getting a vaccine approved as a booster for COVID, what do you think the regulatory authorities such as the FDA and EMA would require in the case of a vaccine that is not approved or has generated efficacy data from a larger study as a primary vaccine? Have the agencies provided guidance? And sort of with that, have you spoken to the regulators about data generated from the challenge study supporting the potential filing as a booster, especially if you can make clear correlations between IgA responses and protection?

James Cummings, Chief Medical Officer

Thank you. This is James. So two things to address. One, we've been in close contact with both the regulatory authorities and have continued dialogue here in the United States with our own U.S. FDA as well as outside the U.S. with the EMA, MHRA, and other countries globally. In terms of a pathway forward, it will rely on having data in hand. That's why our challenge study is so critical. We need to look at that challenge study to obtain key data regarding protection against infection. This, combined with a marker of immunogenicity, will help establish a correlative protection and will be very important. We will also need to consider a decrease in nasal shedding of the virus to address transmission. Overall, decreases in symptomatic disease will significantly help structure what a Phase III follow-on study would look like and inform regulators for clearer pathways forward. It heavily depends on the pandemic situation at that time, particularly if SARS-CoV-2, the virus causing COVID-19, continues to develop new strains. Given that, if we see more disease, more fatalities, and more quarantine issues, then I believe regulators will be more inclined to seek next-generation solutions more urgently.

Pete Stavropoulos, Analyst

Good. One question on the norovirus program: I know that you're planning to initiate a Phase II trial of the bivalent vaccine candidate in Q4. Can you speculate on the size and duration of the study? Will you be looking at immunogenicity or immunogenicity and efficacy, and how will this study differ from those conducted on norovirus previously? Do you think that this data combined with the challenge study may enable a registrational study?

James Cummings, Chief Medical Officer

That's a great question. The upcoming study will be a Phase II, and while it won't be a Phase III, we will certainly look at both immune correlates through this study. We'll leverage data from our challenge study as well as preliminary efficacy. All this will inform the next steps towards a wider, more robust study. We plan to examine dose confirmation and consider results from the challenge study, which we anticipate in late Q1 or early Q2, to discuss our future steps with regulatory bodies.

Pete Stavropoulos, Analyst

If I could fit in one last question. When you think about the norovirus vaccine, where do you see this fitting in the vaccine schedule in the U.S.? Who is expected to benefit the most from a norovirus vaccine?

James Cummings, Chief Medical Officer

Norovirus affects everyone, but it impacts us most dramatically in our early years and later in life. Children up to the age of five are frequently ill with this disease, while after age 55 or 62, we again see another spike in symptomatic disease. When discussing costs, just so you know, there's a 10 billion dollar impact from norovirus infections annually in the United States, with one billion attributed to direct healthcare costs. Therefore, the older and younger populations are most affected, along with healthcare providers, restaurant workers, military personnel, and others. A very wide distribution in vaccination strategies should be anticipated.

Operator, Operator

Our next question comes from the line of Kumar Raja with Brookline Capital.

Kumar Raja, Analyst

Congratulations on all the progress. Regarding the Phase II data, literature suggests previous Omicron infection provides some protection. What are your thoughts on the likelihood of Wuhan S-only to provide protection against the BA.4 and BA.5 variants?

Sean Tucker, Chief Scientific Officer

Yes, that's a great point. As you noted, there is some evidence that previous infection with Omicron can provide protection against subsequent infections. However, we currently do not know how long that protection lasts. People have noticed titers wane from both natural immunity and injected vaccines. As we proceed, we want to ascertain whether our booster, whether it's the Wuhan strain, offers protection against emerging variants. There has been considerable cross-reactivity observed, especially in T cells and nasal mucosa. We are optimistic that our approach has cross-reactive potential, and we intend to assess that clinically to clarify our best path forward.

James Cummings, Chief Medical Officer

To this end, we'll gather the data we mentioned earlier this quarter in Part 1 of Phase II and analyze the influence of other strains. The recommendations from the FDA include addressing BA.4 and BA.5. We'd like to collect data on the Omicron strain and utilize a data-driven approach as we determine our next steps in both the challenge model and larger studies.

Kumar Raja, Analyst

How much of the Wuhan vaccine do you have, and how quickly can you ramp up the manufacturing of the new constructs?

Sean Tucker, Chief Scientific Officer

From the standpoint of supply, we're in great shape to proceed with the next Phase II study. We now control our manufacturing internally, with two facilities located within Vaxart in Northern California, enabling us to move rapidly to produce new constructs.

James Cummings, Chief Medical Officer

I agree with Sean. We’re positioned well in terms of production capacity and have product on hand from the previous S-only construct, allowing us to proceed with future studies.

Kumar Raja, Analyst

For the norovirus bivalent, do you have enough materials to move forward with the planned Phase II trial?

James Cummings, Chief Medical Officer

With our current plans, yes, we're making those products as we speak. We're adopting a bivalent approach, focusing on both G1.1 and G2.4, which we have previously tested in people. This larger study will be a dose confirmation study concerning that outcome.

Operator, Operator

Thank you. I'm showing no further questions in the queue. I would like to turn the call back over to Brant Biehn.

Brant Biehn, Senior Vice President, Business Operations

Thank you, Alex. We've received a few written questions that have come in during the call. Regarding the India study, James covered that in his opening statements, so we’ll skip that one for now. The next question relates to the clinical plan for the norovirus product. Could you provide a brief overview of what that will look like?

James Cummings, Chief Medical Officer

Sure. We're developing our norovirus program currently undergoing a Phase II challenge study. We anticipate releasing that data towards the end of Q1 or beginning of Q2 next year. We will also begin a Phase II dose confirmation study of the bivalent norovirus vaccine candidate. It requires data generation from both studies to navigate discussions with the FDA about a potential Phase III study, which could either focus on efficacy or immunogenicity depending on the data collected. Once we have good data in hand following the Phase III study, we will aim for commercialization.

Brant Biehn, Senior Vice President, Business Operations

From a commercial standpoint, it's crucial to conduct health economic evaluations, which aid in discussions with governments regarding vaccine acceptance and payment. Our health economics study has shown that norovirus disease presents a significant impact annually in the U.S., making it essential to focus on both the under age 5 group and the over 65 population, similar to influenza vaccines.

James Cummings, Chief Medical Officer

Thank you.

Brant Biehn, Senior Vice President, Business Operations

We have some other questions regarding last month's White House COVID Summit. James, would you like to share key takeaways from that meeting?

James Cummings, Chief Medical Officer

Certainly. There was a general acknowledgment that we need next-generation vaccines to navigate this pandemic effectively, especially concerning virus mutations and variants. The initial vaccination campaign has made advances, but more must be done. The importance of mucosal immunity was recognized, with our vaccine seen as a promising solution. Dr. Akiko Iwasaki noted that the mucosal immunity elicited by an oral vaccine is vital for preventing transmission, as viruses are emitted from the oral cavity and nasal cavity. We require various approaches — the more we can assess, the better, but we need resources to achieve this.

Brant Biehn, Senior Vice President, Business Operations

Thank you, James. The next question pertains to Vaxart's oral tablet vaccine and how it differentiates from intranasal candidates. Sean, can you elaborate?

Sean Tucker, Chief Scientific Officer

That's an excellent point. While both intranasal and oral could be effective in preclinical studies, we believe oral tablets are much simpler for consumers to use. There have been significant challenges in developing intranasal vaccines; for instance, FluMist is the only approved intranasal vaccine, which tends to have better results in younger children who lack immunity to the flu. Furthermore, there have been issues causing severe side effects with certain intranasal vaccines, such as the Berna Biotech nasal flu vaccine that led to Bell's palsy and was withdrawn. Going forward, we contend that oral vaccines are simpler for users and could elicit similar responses compared to intranasal delivery.

Brant Biehn, Senior Vice President, Business Operations

Thank you, Sean. One last question is about the human papillomavirus vaccine and its market opportunity. James, would you like to start?

James Cummings, Chief Medical Officer

Certainly, we often discuss the potential for both preventive and therapeutic HPV vaccines. While there's a prevention vaccine available in the U.S. for adolescents, unfortunately, less than 60% of eligible individuals are fully vaccinated, and numbers are even lower in many countries. HPV is associated with over 30,000 cancers yearly in the U.S. alone, as treatment for these cancers can be expensive and challenging. We believe many individuals would prefer an oral vaccine over current treatment options for cancer or pre-cancerous lesions.

Andrei Floroiu, CEO

As James noted, there remains a significant market for an HPV vaccine both in the U.S. and internationally. Our HPV program is particularly intriguing, as it will mark our first therapeutic vaccine, opening new avenues for us. Given the importance of T cells in cancer, our findings from COVID-19 have implications for this area. We're optimistic about the therapeutic vaccine potential.

Sean Tucker, Chief Scientific Officer

Years ago, we developed HPV16 and 18 vaccines and tested them preclinically. They showed potential in preventing tumor growth or reducing tumors in mice. Notably, they were capable of generating strong T cell responses to vaccine candidates. Previous research has indicated that a CD8 T cell response with mucosal markers is crucial in eliminating lesions and cervical dysplasia. Given our platform's demonstrated efficacy, we are optimistic about leveraging it for a good therapeutic vaccine for HPV.

Brant Biehn, Senior Vice President, Business Operations

Finally, a question about potential partnerships for the COVID-19 or norovirus programs. Andrei, could you provide insight into your approach and whether partnerships could accelerate the programs?

Andrei Floroiu, CEO

We remain open to discussions regarding partnerships, as we aim to maximize shareholder value and expedite our platform's potential realization. While we have multiple programs, we are being strategic about when and with whom we enter partnerships in the U.S. and abroad for both COVID-19 and norovirus. We believe that forming the right type of partnership can indeed expedite our programs.

Brant Biehn, Senior Vice President, Business Operations

Thank you, Andrei. Unfortunately, that concludes our Q&A session for today. Thank you for joining us.

Andrei Floroiu, CEO

Thank you.

Operator, Operator

Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.