Vaxart Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 13, 2025

There are 9 speakers on the call.

Operator

Greetings. Welcome to Vaxart Business Update and First Quarter twenty twenty five Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to vaxart.com. As a reminder, this conference is being recorded.

Operator

I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel.

Speaker 1

Good afternoon, and welcome to today's call. Joining us from Vaxart are Stephen Lowe, Chief Executive Officer Doctor. Sean Tucker, Founder and Chief Scientific Officer Doctor. James Cummings, Chief Medical Officer and Philip Lee, Chief Financial Officer. Before we begin, I would like to remind everyone that during this conference call, FactSart 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.

Speaker 1

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 Acthar's most recently filed annual report on Form 10 ks 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 Stephen Lowe. Steve?

Speaker 2

Thanks, Ed, and thanks to all of you for joining us this afternoon. I'd like to begin today's call by acknowledging our partners at BARDA and the Department of Health and Human Services and thanking them for engaging with us in the productive dialogue that has led to the listing of the stop work order on the 10,000 participant portion of our Project NextGen Phase 2b COVID-nineteen vaccine trial. We believe that the additional review and scrutiny of the trial design and the data supporting the safety and efficacy of our COVID-nineteen oral pill vaccine program will ultimately instill greater confidence in these studies results. We acknowledge that some of you have been frustrated that we haven't been providing real time updates regarding our ongoing discussions with BARDA and HHS and we have received many inquiries throughout this period as to our lack of communication with our shareholders. We certainly recognize the importance of timely and transparent communication with you, but we are limited to what information we can share due to our contractual obligations with BARDA and HHS and the confidential nature discussions.

Speaker 2

Adhering to those obligations is essential to the productive relationships we have established with both of these agencies and as I hope you will appreciate has been critical to the continued advancement of our COVID-nineteen program. In balancing the constraints of our Project NextGen contractor obligations with our SEC reporting requirements, we will continue to disclose material information in a timely fashion through our filings on Form eight ks and in those instances where we receive the necessary and timely approvals, we will also issue press releases. James will shortly provide an update on the status of the Phase 2b COVID-nineteen study and the actions we are taking to initiate patient dosing. But the bottom line is that we are delighted to be actively screening patients and are hopeful that we will begin dosing in the 10,000 participant portion of the study in the second quarter of twenty twenty five. Let me also add that we are operating under our current contract with BARDA, which has not changed and still provides up to 460,700,000 for the Phase IIb study.

Speaker 2

James will also provide an update on our norovirus vaccine clinical program, but I want to note that we are pleased to have quickly completed enrollment in our Phase one trial comparing our second generation constructs with our first generation constructs. While this is an open label trial, we are still blinded to all study results at this time. We expect to report top line data from this trial in mid-twenty twenty five in line with our previously stated guidance. We continue to hold meaningful conversations with potential strategic partners who are closely monitoring this upcoming data readout. If the data prove our research thesis of an improved norovirus second generation construct, we believe it could lead to a partnership that would further advance the program and could provide further non dilutive funding to the company.

Speaker 2

Taking a step back, we believe vaccines are essential for the infrastructure of public health. They are by many accounts one of the top public health achievements in the twentieth century. There are also major economic benefits such as lower cost to our healthcare system and increases in overall workplace productivity. Compared to pharmaceutical products, a vaccine can achieve a steady state of revenue at its peak whereas a pharmaceutical can taper off earlier in its product lifecycle. Bringing a new vaccine to market is a lengthy capital intensive process.

Speaker 2

And as we continue to navigate the headwinds in the biotech environment, we had to make some difficult choices in order to achieve our upcoming milestones within our existing cash position. That includes rationalizing our costs through another round of workforce reductions in the past few weeks. It's not something we want to do, but it's unfortunately necessary for us to streamline our costs in order to maximize our future opportunities. Finally, as announced in a press release issued earlier today, Phil Lee submitted his resignation as CFO for personal reasons. I would like to thank Phil for the valuable contributions he has made during his tenure at Backstart.

Speaker 2

We do appreciate his willingness to stay on as a nonexecutive employee for a few weeks to ensure a smooth transition for our incoming CFO, Jerome Grossman. We are very excited that Jerome has joined Backstart. A seasoned executive in healthcare and Drone brings more than twenty years of experience in biotech with his four most recent years at Altru Bio, a clinical stage private biotech company. There he was instrumental in leading finance and operations and helped scale the company for global clinical studies. Jerome also had successful stints at PACT Pharma, Intarsia Therapeutics and Genentech.

Speaker 2

We look forward to working with Jerome and welcome him to our team. I'll now turn the call over to James for a review of our COVID-nineteen and norovirus clinical programs. James?

Speaker 3

Thanks, Steve. I'll start by reiterating Steve's recognition of the collaborative effort and support from our government partners that led to the lifting of the stop work order on the 10,000 participant portion of the COVID-nineteen Phase 2b clinical trial. Following receipt of the notification lifting the hold on April 24, we have restarted the activities needed to initiate dosing in this portion of the study, including reactivating clinical trial sites, screening study participants and coordinating shipment of clinical trial materials. As a reminder, the 10,000 participant portion of this trial will compare the efficacy, immunogenicity and safety of the company's KP2 oral vaccine candidate against an mRNA competitor directed against KP2. Participants in the trial are being followed for twelve months to assess safety, efficacy and immunogenicity of our oral pill COVID-nineteen vaccine candidate.

Speaker 3

Efficacy will be assessed in subjects with and without COVID-nineteen symptoms. Regarding the 400 participant sentinel cohort of the study, we have been continuing our per protocol follow-up activities. In this cohort, we compare our oral pill XBB candidate against an mRNA XBB comparator rather than KP2. While the Sentinel cohort was designed primarily to provide safety information regarding our new vaccine construct, we eagerly anticipate the important initial data on safety, immunogenicity and efficacy that this cohort will provide. COVID-nineteen continues to pose a threat to human health.

Speaker 3

And we believe that our oral pill vaccine candidate has the potential to provide enhanced efficacy compared with injected vaccines because our vaccine candidate stimulates mucosal immunity at sites within the body that are the points of viral entry. We also believe that an orally administered vaccine is an important alternative to individuals who are averse to needle injections. I'll now turn to our norovirus vaccine clinical program. As announced last month, we quickly completed enrollment of all 60 participants in a Phase one open label dose ranging clinical trial designed to enable a head to head comparison of our second generation oral pill norovirus vaccine candidate against our first generation candidate. This study is designed to assess safety and measure immune markers that have correlated with protection and are already completed challenge study conducted with our first generation norovirus vaccine candidate.

Speaker 3

We remain on track to report top line data in mid-twenty twenty five. I know some of you have questions about our rationale for going back to a Phase one development with the second generation norovirus vaccine candidate rather than just continuing to advance our first generation norovirus vaccine construct. The simple answer is that we're a data driven vaccine development company committed to developing oral pill vaccines that are not only first in class, but also provide the most effective and durable protection against infection and disease symptoms and have the highest likelihood of success in the marketplace. This means that we carefully evaluate the results from each of our preclinical and clinical studies and use these data to optimize our vaccine candidates. Based on data generated from our first generation norovirus vaccine candidate in both the completed challenge study and the clinical trial conducted in elderly participants.

Speaker 3

And from the preclinical data obtained from our second generation norovirus vaccine candidate, we anticipate that our second generation vaccine candidate could well provide greater protection against norovirus infection and illness. After conversations with our advisors and regulatory groups, this path forward enables us to advance our norovirus vaccine clinical program with the strongest vaccine candidate. If the results of the Phase one clinical trial are positive, the next step would be to conduct a Phase 2b safety and immunogenicity study that could begin as early as the second half of twenty twenty five, followed by an end of Phase 2b meeting with the FDA and a potential Phase three clinical trial initiating as early as 2026. As we shared with you in the past, these additional trials will require a partnership or other funding. We continue to actively pursue partnerships and we'll provide an update when available.

Speaker 3

I'll now hand the call over to Doctor. Sean Tucker, our Founder and Chief Science Officer for the latest developments from our avian flu preclinical program. Sean?

Speaker 4

Thank you, James. As many of you are aware, the currently circulating H5 bird flu is causing significant outbreaks in wild birds as well as poultry and dairy cows across The United States. To date, the Centers for Disease Control and Prevention has reported seventy cases of avian flu in humans, all of which are believed to have resulted from contact with infected poultry or cows. There is no known person to person spread at this time. Public health concerns regarding the spread of avian flu in people are focused on those individuals at risk of infection due to contact with infected animals.

Speaker 4

However, there is also a concern that continued spread of the virus among animals may enable development of mutations that could make it easier for the virus to infect humans or result in human to human transmission. As the current avian flu outbreak is the largest and longest in U. S. History, there is a growing interest in the need for a safe and effective vaccine that could protect those at risk of infection. Results from recent preclinical studies show that our new avian flu influenza vaccine was 100% protective against death in a robust ferret clay two point three point four point four B challenge model compared with zero percent survival in placebo treated animals.

Speaker 4

We expect to report data from these studies in a peer reviewed forum, which includes presenting the complete results at a scientific or medical conference and eventually publishing the data in a peer reviewed journal. We believe that our avian influenza program has potential as a partnership and business development opportunity and look forward to sharing more data from the program later this year. We believe the relatively short timeline for advancing this new avian flu vaccine candidate to preclinical studies reinforces the power of our vast platform to enable rapid development of novel vaccines that can address the dynamic in evolving infectious disease landscape. Our modular, scalable and standardized approach to vaccine development supports rapid development various vaccines against established targets as well as against new and emerging pathogens. As such, we believe we have an important role to play in innovating vaccines that are easier to develop and to deliver than traditional injected vaccines and mRNA vaccines.

Speaker 4

I'll now hand the call over to Phil Lee, our CFO for a brief discussion of our financials. Phil?

Speaker 5

Thank you, Sean. The details of our first quarter twenty twenty five financial results are summarized in today's press release. Revenue for the first quarter of twenty twenty five was $20,900,000 compared to $2,200,000 for first quarter of twenty twenty four. Revenue in the first quarter of twenty twenty five was primarily from the BARDA contract awarded in June 2024. Revenue in the first quarter of twenty twenty four was primarily from the BARDA contract awarded in January 2024.

Speaker 5

Vaxar ended the first quarter with cash, cash equivalents and investments of $41,900,000 As Steve mentioned earlier, the company implemented additional measures to reduce operating costs and better align its workforce with the needs of its business in the past few weeks. Based on our current plan, Vaxart now expects cash runway into the first quarter of twenty twenty six. To further extend our cash runway, Vaxar will remain aggressive in seeking strategic partnerships and pursuing other non dilutive funding options. As announced in the press release today, I had delivered my notice to resign from Vaxar as Chief Financial Officer. My decision to depart the company at this important juncture was not one that I took lightly, but it was a decision that I made for personal reasons.

Speaker 5

I would like to thank Steve, the Board and the entire organization for giving me the opportunity to work at the leading oral vaccine biotechnology company. I will now turn the call back to Steve for closing remarks.

Speaker 2

Thanks, Phil. And on behalf of the company the Board, we appreciate all the work that you've done for Vaxard and wish you the very best of luck on your future endeavors. Before we open the call to take your questions, I would like to use this time to discuss our upcoming Annual Shareholder Meeting that is taking place virtually on Wednesday, May 21 at 11:30 a. M. Eastern Time, eight thirty a.

Speaker 2

M. Pacific Time. Specifically, I would like to address the reverse stock split in proposal number two and explain our rationale. Like many of our shareholders today, we do not believe our current stock price reflects anywhere close to what we believe is the full value of our company. In fact, members of the management and the Board, like our shareholders, have also suffered losses related to the company's share price decline.

Speaker 2

Nevertheless, we are at risk of being delisted from NASDAQ. And despite our best efforts, including many of the accomplishments our team highlighted earlier, we have not yet been able to regain compliance with NASDAQ's one dollar minimum bid price requirement. We consider the reverse stock split a measure of last resort before the late June deadline. I'd like to use this opportunity to describe why we believe that voting for proposal number two is in the best interest of Vaxart and for you, our shareholders. While a reverse stock split is not something our Board or management desires, we do believe it is necessary for the following reasons.

Speaker 2

First, the primary driver behind the proposed reverse stock split is to ensure our continued listing on NASDAQ. To reiterate, we would prefer to avoid a reverse stock split. However, this is currently our best path forward to regain compliance and maintain our NASDAQ listing. A NASDAQ delisting would likely have a material adverse effect on the value of our company and the value of your stock since liquidity is significantly lower on the OTC markets, which could negatively affect the stock price. As I wrote in my letter to stockholders last week, if we do regain NASDAQ compliance in the required timeframe, the Board does not intend to affect a reverse stock split.

Speaker 2

And second, maintaining our listing on NASDAQ may broaden our investor appeal. Many brokerage firms and investment funds avoid lower priced stocks, discouraging investors from companies not listed on a major exchange. The limitations associated with trading on a less recognized exchange would deter most institutional investors. Furthermore, we anticipate that a delisting could lead to a termination of research coverage by financial analysts. This lack of research coverage would reduce market visibility and potentially negatively impact investor sentiment and understanding of our value proposition.

Speaker 2

I want to be clear that a reverse stock split only causes a change for all issued shares of Vaxcharts common stock uniformly and does not result in dilution. As we stated earlier on this call, we remain aggressive in exploring business development partnerships and non dilutive funding options with the goal of achieving our upcoming clinical and regulatory milestones. In the event that we receive shareholder approval before proceeding to effect a reverse stock split, we will first evaluate our situation to determine the likelihood of regaining compliance with NASDAQ. Several factors continue to change, including, but not limited to, the status of our programs and our stock price. If compliance is not achieved by the June 30 deadline, NASDAQ is expected to issue a written notice indicating that Vaxart's securities will be subject to delisting.

Speaker 2

At that point, Vaxart may appeal the delisting to a NASDAQ hearings panel and present its case for continued listing. However, there is no assurance that NASDAQ will concur with the appeal. We continue to evaluate and exhaust all of our options to avoid a reverse split and maintain our NASDAQ listing. We are proud on the significant breakthroughs that we have accomplished, but there is still much work ahead that will require continued investment. Vaxart has come a long way in developing a novel oral pill vaccine that can reimagine how people are vaccinated globally.

Speaker 2

The recent lifting of the HHS stop work order for our COVID trial is very encouraging, amplified by HHS's stated belief in the need for developing novel vaccine technologies that extend beyond conventional needle based approaches. Your support is essential to positioning Vaxart for continued success. We have received numerous messages from our loyal base of shareholders, and I can attest to having read them. I share your passion and frustration in our share price, but we need your support to get to the finish line and continue our important work in advancing our research. Thanks everyone for your time today.

Speaker 2

We will now open the call for your questions.

Operator

Thank Our first question is from Chang Lee with Oppenheimer and Company. Please proceed.

Speaker 6

Hi, good afternoon. Thanks for taking the questions and congrats on the progress. And Phil, best of luck to you and your future endeavors. Maybe I'd like two questions from me, one on COVID-nineteen and the other on norovirus. For COVID-nineteen program, just curious any color you can share on the gating factor to start patient dosing?

Speaker 6

I think you mentioned you are expecting dosing to start in the second quarter. And also how fast you think you can complete enrollment of the 10,000 participants in the Phase 2b study? And on the norovirus program, just can you help us to set the expectations for the Phase one results? How would you define a positive study? You.

Speaker 2

Great. Hi, Chung, it's Steve. Thank you very much for the questions. On your COVID-nineteen question, I'll make a few comments and then I'll turn over to James as well. On norovirus, I think both Sean and James can take that.

Speaker 2

So as it relates to the gating factors, first of all, we're obviously very pleased with the fact that the stop work order was lifted. And once that was lifted, we frankly, the next day had a conference call, Zoom meeting with BARDA. And in that process of restarting, there were just some things that we needed to start moving forward with, including the screening of patients, etcetera. So those are the natural next steps in the study. And once we get to check off some of those steps, our hope is that we'll be given the green light to start dosing.

Speaker 2

I'll turn it over to James if he wants to add just some additional details behind that.

Speaker 3

Sure. Thanks, Steve. So in terms of the duration of enrollment for the study, I'd say approximately five to six months. I say approximately because we'll take a look at what enrollment after screening looks like over the first several weeks and adjust our expectations there. Hopefully that answers that question.

Speaker 3

Over.

Speaker 2

Great. And then, Chung, what we can do is you had a question on norovirus and specifically what does a Phase one success look like? Sean, at a high level, you want to address that and then James, if you want to add?

Speaker 4

Yes. I think from our standpoint, I think success would be that the new constructs are trending better than the old constructs. We did not the size of the study is not enough to look for statistical significance, but we do expect that the new constructs will do a little bit better on key immunogenicity endpoints.

Speaker 3

And I'll concur. I think that we're basing moving forward with that study based on some of the preclinical data that's compelling. So look forward to having that data, top line data sometime midyear.

Speaker 2

Yes. We're certainly very Thanks, Sheng. Yes, we're certainly pleased that we were able to complete the enrollment as fast as we could to really get to that milestone.

Speaker 6

Yes. Thanks for all the color.

Operator

Our next question is from Mayank Mamtani with B. Riley Securities. Please proceed.

Speaker 7

Yes. Good afternoon, team. Thanks for taking my questions. Best wishes to Phil and look forward to working with Jeron. Yes, just maybe following up on the COVID program.

Speaker 7

The specific BARDA correspondence that you're having prior to initiating dosing in the ten ks subject trial, have there been any learnings from the Sentinel cohort that is informative to these discussions? And maybe also if you could comment on how you may want to handle the results from the Sentinel cohort in later part of this year? And then I have a follow-up on your advice.

Speaker 2

Great. Yes, I'll let James add some more details here. Like I was saying earlier, the conversations have been really productive. I think we do incorporate all that we learn from enrollment, etcetera, and as well as how we ship comparator as well as our product to the different sites. So that's certainly been something that we continue to build upon.

Speaker 2

Let me turn over to James in terms of specifics with the study.

Speaker 3

Thanks, Steve. So after now that we are off the pause and we are currently activating or reactivating study sites and screening individuals, that's really your first step prior to enrollment and dosing. And we've activated 20 sites and we've screened approximately 199 folks are in screening right now. And that process, there's an up curve to that, that will continue to climb as we activate more sites and, maintain a very, I think strong posture in terms of screening and enrollment. Over.

Speaker 7

My question was around the Sentinel cohort, that 400 subject, because we know that data could be helpful to in many ways, including to your point enrollment. James, if you could maybe comment on that.

Speaker 3

Sure. So I'd say that we intend to engage with our partners on BARDA to determine if some sort of interim analysis with that group would be mutually advantageous to both parties. The study is set to conclude in terms of the twelve months of safety follow-up by December of this year. We are blinded as well. This is a double blinded study.

Speaker 3

So currently, can't give you any color further than that.

Speaker 7

And then, about the recent DSMB review for your neurovirus trial, could you touch on maybe what items were looked at? And also, if you could comment on, what we saw in your recent Phase 1b publication and kind of the entire package that's coming together. If you want to have end of Phase two meeting, I assume some of the prior generation construct data would also be relevant to be engaging the regulators. Could you maybe put all that together, how you're planning to do that end of this year? Thanks for taking my questions.

Speaker 2

Sure. James can provide some detail there, but just in terms of from a interaction with the FDA, I think we've said in the past, right, they look totality of the data. So all of that's incorporated. But James, feel free to add some more color.

Speaker 3

Thanks, Steve. So in terms of our SMC or Safety Monitoring Committee for that Phase one, what we were looking at serially, it's safety to ensure that we see a clean safety profile with no areas of concern to move forward with the protocol as designed and written. And the safety data was reviewed upon completion of the low dose cohort and then after some central members of the higher dose cohort. Again, along with our ENPART platform, we see consistently safety profile that is very similar to placebo. For details in terms of the Phase one, Sean, do you want to comment on your thoughts in terms of the immunologic outcomes there?

Speaker 3

Over.

Speaker 4

Sure. After completion of the challenge study, we were able to identify a couple of key immune parameters that we thought were important. The first of which is looking at essentially functional antibodies in sera as well as fecal IgA responses. We will measure both of these parameters in the new study. And our hope based on our preclinical work is that the new constructs will trend better than the old construct.

Speaker 4

Over.

Speaker 7

Thank you.

Operator

Our final question is from Roger Song with Jefferies. Please proceed.

Speaker 8

Hey, this is Liang Chun on for Roger. Thanks for taking our questions and congrats on the progress. So I guess a couple of questions from us. First part is the COVID program. So wonder what's the stop order?

Speaker 8

What's the impact on your expected timeline to complete a study regarding maybe quickly remind us where are you conducting a study? And how do you think about the seasonality there? And then on the novel virus program, so understanding that Phase two will probably be pending on potential partnership. So any active conversations that is ongoing at right now? Thank you.

Speaker 2

Hi, Leon. Thanks for the question. I'll go ahead and chat briefly about the stock work order and then James could add his perspective and then we'll go into the partnership question. So number one, I think we were very pleased that when we received the stop work order on February 21, it was for ninety days. And the fact that it was lifted within sixty, sixty two days afterwards, certainly exceeded our expectations because we thought we would go the full ninety days.

Speaker 2

I think as well to your question, right, there was sixty days where we couldn't do anything and that had some minor impact. And James can talk about the fact that we as he mentioned earlier, right, we were trying to reactivate the sites as soon as possible. But James, if you want to just cover anything from an enrollment standpoint and projections?

Speaker 3

Sure. So as part of the study, the stop work order or the pause did impact the 10,000 person cohort of this study, but we continued with the 400 person sentinel study. They had already been dosed. We were already observing them for safety, and that continues. That 400 person sentinel group, as I mentioned, should conclude the clinical follow-up in December of this year and then project out after unblinding analysis of samples, cleaning of data, a three to six month time frame in terms of some data there.

Speaker 3

In terms of the 10,000 person cohort, once we begin dosing, I would project and this is a projection about a six month enrollment period. We'll learn more as we continue screening and then begin enrolling and dosing individuals about the period of time that that will take. From the time the last person is enrolled, there's a twelve month follow-up period where we're looking at safety and immunogenicity, but also efficacy both from a symptomatic standpoint of someone who has symptoms and comes in to be, screened to see if they actually have the SARS CoV-two virus and COVID-nineteen infection, as well as asymptomatic surveillance that will occur, for twelve months after they've received either our investigational, vaccine construct or the, the approved vaccine.

Speaker 2

And I

Speaker 3

think that's very interesting from the way that, COVID nineteen, the SARS CoV two virus, operates because it mutates over time. And so we'll take a look at not just the protective efficacy, but also take a look at, what types of viruses may have mutated, that may not be as good for a direct IgG response, but we feel our mucosal response should potentially have an advantage.

Speaker 6

Over. Great.

Speaker 2

Leong, this is Steve. I'll go ahead and address your question on norovirus partnership discussions, right? So number one, we see norovirus as a very important opportunity, right? There's an unmet need here. We're aware of many companies who are pursuing norovirus as well.

Speaker 2

So I think that's a promising market, as well as the fact that there are many companies out there that don't have a norovirus vaccine in their portfolio. And certainly, you're a large global multinational company, that is something that could be desirable. We are having discussions with a broad and diverse range of companies. And like I said, they include some of the large multinational companies, some medium sized companies as well. These companies are both global as well as some regional players that are in The United States, but also outside The United States.

Speaker 2

And I think everyone is waiting like we are for the top line results, which we've guided everyone to midyear of this year. So I think upon those results, it's our expectation that those discussions will accelerate. But from our standpoint, we're pleased that there is interest in norovirus. It certainly supports our thesis that this is a great market opportunity. And frankly, we're the only ones that I'm aware of that have an oral vaccine that's in development.

Speaker 8

Very helpful. Thanks for the additional color.

Operator

With no further phone questions, I would like to turn the conference back over to Ed Berg for our written question portion of the call.

Speaker 1

Thank you, operator. I want to thank our shareholders. They have submitted quite a number of written questions and the questions were around both our programs, our science, financial matters and our proposed reverse stock split. And so we'll handle the questions in that order. The first question is for Steve around our COVID program.

Speaker 1

Since you're currently the only company to get a stop work order lifted for Project NextGen, can you elaborate on your conversations with BARDA and HHS?

Speaker 2

Yes. Thanks, Ed. So first of all, as I stated earlier, we are grateful and thankful that we have the stop work order lifted. And I think that's the result of some productive conversations that we had with BARDA and HHS throughout that process. They certainly evaluated our program on the merits as well as on the science.

Speaker 2

From our standpoint, these are productive conversations, and I'm sure everyone will respect that they also need to be confidential. We've been asked that these conversations are, I think, at a point where we're not able to share because of the fact that we want to respect our contract with them. But certainly, we believe that they were productive and it could be one of the reasons why the soft work order was lifted.

Speaker 1

Thanks. I do want to add that we only know about our program and what's been publicly announced. We don't have any information about other programs beyond that, just for everyone's clarity. A question on the neurovirus front from a shareholder. In the neurovirus trial, you're testing a low dose and high dose and have mentioned dose specific responses in prior trial results.

Speaker 1

If this is the case, why was the decision made to use a lower dose for the Phase one clinical trial? James, if you could cover that.

Speaker 3

Sure. Thanks, Ed. So the dose we used in our previous Phase II trial was a 1e11 per strain dose. Don't forget this is a bivalent vaccine, so there's two strains. And it was based on safety and immunogenicity data from the previous trials.

Speaker 3

We intend in this study to compare the 1e11 dosage of a legacy vaccine with both a low 1e10 and a high 1e11 dosage per strain of our second generation norovirus candidate. This is going to allow us to choose the correct dosage moving forward. Dose ranging studies are really best practice for any new vaccine construct. So we're conducting this study to determine the best dose to provide us with the best chance of enhancing efficacy and similar safety. Over.

Speaker 1

Thanks, James. We have a question for Sean on avian flu. The avian flu preliminary results appear very promising. How quickly can the candidate enter the clinic?

Speaker 4

Right now, we're still in preclinical investigations. We have some other things coming up. Obviously, we do think that our candidates can be manufactured very quickly. And right now, we're getting ready to prepare some drug products for clinical use. Obviously, we're ready with the done with the results, we'll publish them when they're available.

Speaker 1

Thanks. And a science question for Sean. HHS recently directed $500,000,000 to progress universal influenza vaccines that could protect against any strain of the virus. What are your thoughts on the results of that vaccine versus Vaxart's? And do you see the cross reactivity of Vaxart's vaccine as on par with theirs?

Speaker 4

Well, we certainly appreciate that HHS is investing money in innovative approaches to vaccine and technology, including ours. We do believe our unique mechanism of action as well as convenience has the potential to set us apart from any other vaccine technology out there. Another thing is we believe our ability to generate cross reactive IgA may be beneficial for flu as well as for other indications.

Speaker 1

Thank you. We'll move on from our programs to financial questions. For Steve, sorry, for Phil. You've received funding from the government and you could be receiving more under this award. Can't use that money to fund the operations of the company?

Speaker 5

So, I think the best way to address this is really by starting by stating a few of the key financial terms of the award. The first one is that it does provide funding for up to $460,700,000 as of today. Importantly, of that 460,700,000 really $240,100,000 is currently available for payment. And then as disclosed in today's press release, the company has actually already received $85,600,000 of cash payments through 03/31/2025. So what does that mean for Vaxart?

Speaker 5

Well, a vast majority of these payments that Vaxart receives are actually used to pay the vendors to run the COVID-nineteen Phase 2b trial. There is a portion of this award that covers a portion of our overhead as well as a fee paid to Vaxart for conducting this trial. So we do actually use that portion to help cover, operations of the company and that is actually considered in our current cash runway guidance of cash into the first quarter of twenty twenty six. I think I'd also like to reiterate that like any other government contract, the full operations of the company are not funded by this award.

Speaker 1

Thanks, Phil. One other financial question for you. Did you raise money off the ATM that you put in place in March?

Speaker 5

So for those that are on the call and just aren't actually aware, we did file for an at the market. So that's otherwise known as an ATM offering in March of this year. So by filing for the ATM, it allows Vaxart to have the option, but not the obligation to actually raise and in our case up to $50,000,000 by selling shares in the open market. As mentioned earlier, like many of you, we do really believe we are undervalued. And in fact, we don't want to raise money at the current stock price.

Speaker 5

So since we've put the ATM in place in March, we have not sold any shares through the date of this call. If I could just summarize there, really just no equity financings or dilution related to financings have really occurred since the last earnings report.

Speaker 1

Thanks Phil. We'll move on to questions around the reverse stock split And these are for Steve. So first, what went into the decision to keep the authorized share count unchanged? Can that be amended prior to the annual meeting?

Speaker 2

Well, first of all, what I want to do is acknowledge and thank all the folks with questions, all of our shareholders and also specifically our retail shareholders who are very passionate about this subject. We receive a lot of questions there and really want to acknowledge that and that we understand your concerns there. Given where we are in the process, we did look into how we could amend the proposal, just given unfortunately the shareholder meeting is next week, so it's a little late in the process to amend the proposal. With that said, we are taking into consideration your concerns. We're looking into and evaluating how best to address this in time for the annual meeting.

Speaker 2

We know it's important to you, and from our standpoint as well, it's not our intent to, as Phil mentioned, do a lot of have a lot of dilution in our stock. We will look into this and certainly have an update whenever we can.

Speaker 1

Thanks, Steve. I'm going to shift to a related question. Are you planning to revise the reverse stock split to a more reasonable level? What goes into determining the ratio of the split if approved?

Speaker 2

Yes. So when we first started working on this, and I also want to just update folks that in our filing with NASDAQ to stay in compliance, we're in the second six months of that. And part of that requirement to regain compliance in our discussions with NASDAQ is the fact that we do have to show a plan on getting above $1 and that actually includes the fact that we have to look at a reverse stock split. So that was the first step. The next step was let's look at a range that could make sense.

Speaker 2

And we had a the Board had a wide range to maximize flexibility. With that said, we, at present, don't have the intention of trying to affect a reverse split in the one to 50 ratio. As I mentioned in one of the recent stockholder letters, the Board really intends to select a ratio for the reverse stock split if approved, that's high enough to have us cure the NASDAQ deficiency. Obviously, we prefer not to have to do that through the achievement of our important milestones and continued execution on our plans. But if we are in that situation, then our intent is to only select the ratio that's small enough to get us into compliance with NASDAQ.

Speaker 1

Thanks, Steve. And another question, if compliance isn't regained in time, are you preparing to appeal to NASDAQ for an extension, especially considering the recent program pause?

Speaker 2

Sure. So as I was saying earlier, when we received the second six month extension from NASDAQ, it was contingent upon our company having a plan to effect a reverse stock split. So it is part of the process, which is why we are putting the vote forward to our shareholders. We have been informed by NASDAQ that they do not engage in the dialogue about extension until after the June 30 deadline. And this is why we want to have the optionality.

Speaker 2

Obviously, we are requesting and asking our shareholders to vote for the proposal number two with our intent of only using it if we have to.

Speaker 1

Thanks. And I think we'll end on this question, which I know some of our shareholders have really wondered about, which is why don't you just delist from NASDAQ and trade on the OTC market?

Speaker 2

Thanks. And yes, that's a frequent comment. And we've investigated this. We looked into it as well. And from what we can see, a delisting from NASDAQ would have a significantly detrimental impact on the value of our shares.

Speaker 2

When a company is traded on an OTC market, liquidity is quite much lower, which could also negatively impact the stock price. As you may know, many brokerage firms and investment funds really steer clear of the lower priced stocks and companies that are not on a major exchange, which could also discourage other potential investors. The restrictions that come with trading on a less prominent exchange could also deter the institutional investors. And so we aren't we don't really desire being on that type of an exchange because it could also result in dropping research coverage by our covering analysts who have been very supportive and we have a good relationship with them. So long and short of it is, we certainly believe that staying on NASDAQ is in the best interest of the company and its shareholders.

Speaker 1

Thank you, Steve. That's all the questions we have at this time. Operator, can you close us out?

Operator

Yes. Thank you. This concludes today's conference. You may disconnect your lines at this time and thank you for your participation.

Powered by Quartr
Earnings Conference Call
Vaxart Q1 2025
00:00 / 00:00