Q1 2025 Vaxart Inc Earnings Call
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Speaker Change: As a reminder, this conference is being recorded I would now like to turn the webcast over to your host Ed Burke Senior Vice President and General Counsel.
Good afternoon, and welcome to today's call.
Speaker Change: Joining us from <unk> are Stephen Lowe, Chief Executive Officer, Dr. Sean Tucker founder and Chief Scientific Officer Dr.
Steven Lo: I will now turn the call back to Steve for closing remarks. Thanks, Phil. And on behalf of the company and the board, we appreciate all the work that you've done for Vaxart and wish you the very best of luck on your future endeavors.
Speaker Change: Dr. James Cummings, Chief Medical Officer.
Philip Lee: And Philip Lee Chief Financial Officer.
Speaker Change: Before we begin.
Speaker Change: I would like to remind everyone that during this conference call.
Edward Berg: 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 21st at 1130 a.m. Eastern Time, 830 a.m. Pacific Time.
Speaker Change: <unk> may make forward looking statements.
Speaker Change: Including statements about the company's financial results financial guidance, its future business strategies and operations and.
Speaker Change: And its product development and regulatory progress, including statements about its ongoing or planned clinical trials.
Steven Lo: 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. Nevertheless, we are at risk of being delisted from NASDAQ. And despite our best accomplishments our team highlighted earlier, we have not yet been able to regain compliance with NASDAQ's $1 minimum bid price requirement.
Speaker Change: 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.
Speaker Change: And other risks described in the risk factors section of <unk>. Most recently filed annual report on Form 10-K.
And also on other periodic reports filed with the SEC.
Speaker Change: <unk> undertakes no obligation to update any forward looking statements.
Speaker Change: After the date of this call.
Stephen: I'll now turn the call over to Stephen well Steve.
Steven Lo: 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. 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.
Stephen: 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 and the productive dialogue that has led to the lifting of the stop work order on the 10000.
Stephen: Participant portion of our project Nextgen phase to be COVID-19 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-19, oral pill vaccine program will ultimately instill greater.
Stephen: <unk> in the study 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.
Steven Lo: 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 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.
Stephen: <unk> with you.
Stephen: But we are limited to what information, we can share due to our contractual obligations with BARDA and HHS and the confidential nature of these discussions adhering to those obligations is essential to the productive relationships. We have established with both of these agencies and.
Stephen: As I Hope you will appreciate has been critical to the continued advancement of our COVID-19 program.
Stephen: In balancing the constraints of our project Nextgen contractual obligations with our SEC reporting requirements. We will continue to disclose material information in a timely fashion through our filings on form 8-K, and in those instances, where we received the necessary and timely <unk>.
Steven Lo: 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. I want to be clear that a reverse stock split only causes a change for all issued shares of Vaxart's 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 milestone.
Stephen: <unk>, we will also issue press releases.
Speaker Change: James will shortly provide an update on the status of the phase <unk> COVID-19 study and the actions we are taken 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 10000 participants portion of the study.
Speaker Change: In the second quarter of 2025, let me also add that we are operating under our current contract with BARDA, which has not changed and still provides up to $467 million for the phase <unk> study.
Steven Lo: In the event that we receive shareholder approval before proceeding to affect 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 30th deadline, NASDAQ is expected to issue a written notice indicating that Vaxart's securities will be subject to delisting. 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.
Speaker Change: 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 <unk> trial, comparing our second generation contracts with our first generation construct while this is an open label trial, we are still blinded to all study results.
Speaker Change: This time, we expect to report topline data from this trial in mid 2025 in line with our previously stated guidance.
Speaker Change: We continue to hold meaningful conversations with potential strategic partners, who are closely monitoring this upcoming data readouts.
Speaker Change: The data prove our research thesis of an improved norovirus second generation construct we believed it could lead to a partnership that would further advance the program and could provide further non dilutive funding to the company.
Steven Lo: We continue to evaluate and exhaust all of our options to avoid a reverse split and maintain our NASDAQ listing.
Steven Lo: 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. 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.
Speaker Change: Taking a step back we believe vaccines are essential for the infrastructure of public health.
Speaker Change: They are by many accounts one of the top public health achievements and the 20th century.
Speaker Change: There are also major economic benefits, such as lower cost to our health care system and increases in overall workplace productivity comparative 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.
Steven Lo: 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.
Speaker Change: Bringing a new vaccine to market is a lengthy capital intensive process and as we continue to navigate the headwinds and 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.
Edward Berg: Thanks, everyone, for your time today. We will now open the call for your questions. Thank you.
Speaker Change: Through another round of workforce reductions and the past few weeks. It is not something we want to do but it's unfortunately necessary for us to streamline our costs in order to maximize our future opportunities.
Operator: If you would like to ask a question, please press star one on your telephone. The confirmation tone will indicate your line is in the question.
Operator: press star 2 to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star 2.
Speaker Change: Finally, as announced 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 <unk>. We do appreciate his willingness to stay on as a nonexecutive employee for one.
Cheng Li: moment while we pull for Our first question is from Cheng Li with Oppenheimer Oh, hi, good afternoon. Thanks for taking the questions and congrats on the progress. And Phil, best luck to you and your future endeavors.
Speaker Change: <unk> weeks to ensure a smooth transition for our incoming CFO Jerome <unk>.
Speaker Change: We are very excited that drone has joined back start.
Cheng Li: Maybe I'd like two questions from me, one on COVID-19 and the other on norovirus. For COVID-19 program, I'm just curious any color you can share on the gating factor to start patient dosing. 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.
Speaker Change: Seasoned executive in health care, and finance drone brings more than 20 years of experience in biotech with his for most recent years at our true bio a clinical stage private biotech company, where he was instrumental in leading finance and operations and help scale the company for global clinic.
Speaker Change: <unk> studies.
Speaker Change: <unk> also had successful stints at pact pharma and Tarsia Therapeutics and Genentech, we look forward to working with drone and welcome him to our team.
Cheng Li: And on the norovirus program. Can you help us to set the expectations for the phase-out results and how would you define a positive study? Thank you.
Speaker Change: I'll now turn the call over to James for a review of our COVID-19, and norovirus clinical programs James.
Steven Lo: Great. Hi, Cheng and Steve. Thank you very much for the questions. On your COVID-19 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. So, you know, 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, you know, in that process of restarting, there were just some things that we needed to start moving forward with, including the screening of patients, etc.
Speaker Change: Thanks, Steve.
James Cummings: I'll start by reiterating steves recognition of the collaborative effort and support from our government partners that led to the lifting of the stop work order on the 10000 participant portion of the COVID-19 phase two b clinical trial.
James Cummings: Following receipt of the notification lifting the hold on April 24th 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.
James Cummings: As a reminder, the 10000 participant portion of this trial will compare the efficacy immunogenicity and safety of the company's K T. Two oral vaccine candidate against an mrna competitor directed against <unk>.
James Cummings: So, you know, 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.
Participants in the trial are being followed for 12 months to assess safety efficacy and immunogenicity of our oral pill COVID-19 vaccine candidate.
James Cummings: I'll turn over to James if he wants to add just some additional details behind that. 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. Over. Great.
James Cummings: Efficacy will be assessed in subjects with and without COVID-19 incentives.
James Cummings: Regarding the 400 participants Sentinel cohort of this study we have been continuing our per protocol follow up activities.
In this cohort, we compare our oral till SPD candidate against an mrna SPD comparator rather than <unk>.
Sean Tucker: And then Cheng, what we can do is you had a question on norovirus and specifically, you know, 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? Yeah, I think from our standpoint, I think success would be that the new constructs are trending better than the old constructs. We did not, you know, 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 a key immunogenicity endpoint.
James Cummings: While our Sentinel cohort was designed primarily to provide safety information regarding our new vaccine construct we eagerly anticipate the important initial data on safety and Immunogenicity and efficacy that this cohort will provide.
James Cummings: COVID-19 continues to pose a threat to human health.
James Cummings: And we believe that our oral pill vaccine candidate has the potential to provide enhanced efficacy compared with injected vaccines because.
Sean Tucker: And I'll concur. I think that, you know, we're basing moving forward with that study based on some of the preclinical data that's compelling.
James Cummings: Our vaccine candidates stimulates mucosal immunity at sites within the body that are the points of viral entry.
James Cummings: We also believe that an orally administered vaccine is an important alternative to individuals who are averse to needle injections.
James Cummings: So look forward to having that data, top line data sometime this year. And yeah, we're certainly very much about. Thanks, Sean.
James Cummings: I will now turn to our norovirus vaccine clinical program.
James Cummings: Yeah, we're certainly pleased that we were able to complete the enrollment as fast as we could to really get to that milestone. Yep.
As announced last month.
James Cummings: We quickly completed enrollment of all 60 participants in our phase one open label dose ranging clinical trial designed to enable a head to head comparison of our second generation oral pill norovirus vaccine candidates against our first generation candidate.
Mayank Mamtani: Our next question is from Mayank Mamtani with B. Reilly. Yes, good afternoon, Dean. Thanks for taking our questions. Best wishes to Phil and look forward to working with Jerron.
James Cummings: 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.
James Cummings: Yeah, just maybe following up on the COVID program, you know, the specific VADA correspondence that you're having prior to initiating dosing in the 10K subject trial, have there been any learning 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 will follow up on your question. Great.
James Cummings: We remain on track to report topline data in mid 2025.
I know some of you have questions about our rationale for going back to a phase one development with the second generation norovirus vaccine candidates rather than just continuing to advance our first generation norovirus vaccine construct.
James Cummings: The simple answer is that we are 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.
James Cummings: Yeah, I'll let James add some more details here. And like I was saying earlier, the conversations have been really productive. I think we do incorporate all that we learned from enrollment, etc. And as well as, you know, how we ship Comparator as well as our product to the different sites. So that's certainly been, you know, something that we continue to build upon.
James Cummings: <unk> in the marketplace.
James Cummings: 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.
James Cummings: Let me turn it over to James in terms of specifics with the study. Thanks, Steve. So, you know, 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 we've activated 20 sites and we've screened approximately 199 folks are in screening right now. And that process, you know, there's a 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.
James Cummings: Based on data generated from our first generation Norovirus vaccine candidate and both the completed challenge study and the clinical trial conducted in elderly participants.
James Cummings: 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.
James Cummings: After conversations with our advisers and regulatory groups. This path forward enables us to advance our norovirus vaccine clinical program with the strongest vaccine candidate.
James Cummings: If the results of the phase one clinical trial are positive. The next step would be to conduct a phase <unk> safety and Immunogenicity study that could begin as early as the second half of 2025.
James Cummings: Over.
James Cummings: I'm sorry, my question was around the Sentinel cohort, that 400 subject, because, you know, that data could be helpful to, you know, in many ways, including to your point enrollment, James, if you could maybe comment on that. Sure, so I'd say that we intend to engage with our partners at 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 12 months of safety follow up by December of this year. We are blinded as well. This is a double blinded study.
James Cummings: Followed by an end of phase II meeting with the FDA and a potential phase III clinical trial initiating as early as 2026.
James Cummings: As we shared with you in the past these additional trials will require a partnership or other funding.
James Cummings: We continue to actively pursue partnerships and we will provide an update when available.
James Cummings: I'll now hand, the call over to Dr. Shawn Tucker, our founder and Chief Science Officer for the latest developments from our avian flu preclinical program.
James Cummings: <unk>.
Thank you James as many of you are aware the currently circulating H five 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 70 cases of avian flu in humans all of which are believed to have resulted from <unk>.
James Cummings: So currently, I can't give you any color further than that. Thank you.
James Cummings: 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. You know, if you want to have an end of Phase 2 meeting, I assume some of the prior generation construct data would also be relevant to be engaging the regulators.
James Cummings: Contact with infected poultry or cows.
James Cummings: There is no known person to person spread at this time public.
Public health concerns regarding the spread of avian flu and people are focused on those individuals at risk of infection due to contact with infected animals.
However, there is also a concern that continued spread of the virus among animals may enable the development of mutations that could make it easier for the virus to infect humans or result in human to human transmission.
James Cummings: Could you maybe put all that together, how you're planning to do that end of this year? Thanks for taking the question. Sure, James can provide some detail there. But just in terms of from a interaction with the FDA, you know, I think we've said in the past, right, they look at the totality of the data. So, you know, all of that's incorporated. But James, feel free to add some more color. Thanks, Steve. So, you know, in terms of our SMC or Safety Monitoring Committee for the, 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.
James Cummings: As the current avian flu outbreak is the largest and longest in U S. History. There is a growing interest and the need for a safe and effective vaccine that could protect those at risk of infection.
James Cummings: Results from our recent pre cooked from recent preclinical studies show that our new avian flu influenza vaccine with 100% protective against death in a robust Barrett Clay 2344, B challenge model compared with zero percent survival in placebo treated animals, we expect to report day.
James Cummings: 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.
Sean Tucker: And, you know, the safety data was reviewed upon completion of the low dose cohort. And then, after some central members of the higher dose cohort, again, you know, along with our entire platform, we see consistently a safety profile that is very similar to.
James Cummings: We believe that our avian influenza program has the potential as a partnership and business operate development opportunity and look forward to sharing more data from the program later this year.
James Cummings: 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 and evolving infectious disease landscape are modular scalable and standardized.
Sean Tucker: For details in terms of the phase one, Sean, do you want to comment on your thoughts in terms of the immunologic outcomes there? 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. While we will measure both of these parameters, the new study and our hope based on our preclinical work is that the new constructs will trend better than the old construct. Over. Thank you.
James Cummings: Approach to vaccine development sports rapid development, various vaccine against established targets as well as against new and emerging pathogens.
James Cummings: As such we believe we have an important role to play in innovating vaccines that are easier to develop and deliver than traditional injected vaccines in mrna vaccines.
Phil Lee: 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 first quarter of 2025 financial results are summarized in today's press release.
Phil Lee: Revenue for the first quarter of 2025 of $20 9 million.
Liang Cheng: Our final question is from Roger Song with Jeff.
Phil Lee: Compared to $2 2 million or first quarter of 2024.
Liang Cheng: Hey, this is Liang Cheng for Roger. Thanks for taking our questions and congrats on the progress. So I guess a couple of questions from us.
Phil Lee: Revenue in the first quarter of 2025 was primarily from the BARDA contract awarded in June 2024.
Phil Lee: Revenue in the first quarter of 2024 was primarily from the BARDA contract awarded in January 2024.
Steven Lo: First about the COVID program. So, you know, wonder what's the stop order, what's the impact on your expected timeline to complete a study regarding, you know, maybe quickly remind us where are you conducting a study and how do you think about the scenality there? And then on the novel virus program, so understanding that phase two will probably be depending on potential partnership. So any active conversation that is ongoing right now?
Phil Lee: <unk> ended the first quarter with cash cash equivalents and investments of $41 9 million.
Phil Lee: 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.
Phil Lee: On our current plan <unk> now expect cash runway into the first quarter of 2026 to.
Phil Lee: To further extend our cash runway.
Phil Lee: We will remain aggressive in seeking strategic partnerships and pursuing other non dilutive funding options.
Steven Lo: Thank you. Hi, Liang. Thanks for the question. I'll go ahead and chat briefly about the stop 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, you know, when we received the stop work order on February 21, it was for 90 days. And the fact that it was lifted within 60-62 days afterwards certainly exceeded our expectations because we thought we would go the full 90 days. You know, I think as well to your question, right, that there was 60 days where we couldn't do anything and, you know, that had some minor impact.
Phil Lee: As announced in our press release today I had delivered by notice to resign from Baxter as Chief Financial Officer, Mike.
Phil Lee: My decision to depart the company at this important juncture was not one that I took lightly.
Phil Lee: It was a decision that I made for personal reasons.
Phil Lee: 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.
Phil Lee: Now I'll turn the call back to Steve for closing remarks.
Steve: Thanks, Phil and on behalf of the company and the board. We appreciate all the work that you've done for <unk> and wish you. The very best of luck on your future endeavors.
James Cummings: And James can talk about the fact that, you know, 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. Very helpful. Thanks for the additional cover.
Speaker Change: 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, <unk> am Pacific time, specifically I would like to address the reverse stock.
Speaker Change: And proposal number two and explain our rationale.
Speaker Change: Like many of our shareholders today, we do not believe our current stock price reflects Andy we're closer 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. Nevertheless.
Speaker Change: 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 been yet been able to regain compliance with nasdaq's $1 minimum bid price requirement, we consider the reverse stock split.
Speaker Change: <unk> of last resort before the late June deadline.
Speaker Change: I'd like to use this opportunity to describe why we believe that voting for proposal number two is in the best interest of <unk> and for you our shareholders.
Speaker Change: While a reverse stock split is not something our board or management desires. We do believe it is necessary for the following reasons.
Speaker Change: First the primary driver behind the proposed reverse stock split is to ensure our continued listing on NASDAQ <unk>.
Speaker Change: 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.
Speaker Change: <unk> 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.
Speaker Change: As I wrote in my letter to stockholders last week, if we do regained NASDAQ compliance in the required timeframe. The board does not intend to effect a reverse stock split.
Speaker Change: And second maintaining our listing on NASDAQ may broaden our investor appeal, many brokerage firms and investment funds avoid lower price stocks discouraging investors from companies not listed on a major exchange the limitations associated with trading on a less recognized exchange.
Speaker Change: <unk> wood detour, 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.
Speaker Change: Understanding of our value proposition.
I wanted to be clear that a reverse stock split only causes a change for all issued shares of <unk> common stock uniformly and does not result in dilution as we stated earlier on this call we remain aggressive fixed.
Speaker Change: Exploring business development partnerships and non dilutive funding options with the goal of achieving our upcoming clinical and regulatory milestones.
Speaker Change: 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.
Speaker Change: Several factors continue to change, including but not limited to the status of our programs and our stock price is compliance is not achieved by the June 30 deadline. NASDAQ is expected to issue a written notice, indicating that <unk> securities will be subject to delisting.
Edward Berg: No further phone questions, I would like Back over to Ed Berg for our Thank you, operator.
Speaker Change: At that point, the Vac start 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.
Edward Berg: I want to thank our shareholders, they have submitted quite a number of written questions and a 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.
Speaker Change: And maintain our NASDAQ listing.
Speaker Change: We are proud on the significant breakthroughs that we have accomplished but there is still much work ahead that will require continued investment <unk> has come a long way in developing a novel oral pill vaccine that can re imagine how people are vaccinated globally. The recent lifting of the HHS stop work order for.
Steven Lo: The first question is for Steve around our COVID program. Since you're currently the only company. to get a Stop Work Order Lifted for Project Next Gen. Can you elaborate on your conversations with BARDA and HHS? Yeah, thanks. So first of all, as I stated earlier, we are grateful and thankful that we have the stop work order lifted. You know, and I think that's the result of some productive conversations that we had with BARDA and HHS throughout that process. You know, they certainly evaluated our program on the merits as well as on the science. You know, from our standpoint, these are productive conversations, and I'm sure everyone will respect that they also need to be confidential.
Speaker Change: Our Covid trial is very encouraging amplified by Hhs's stay the belief in the need for developing novel vaccine technologies that extend beyond conventional needle based approaches.
Speaker Change: Your support is essential to positioning <unk> for continued success.
Speaker Change: We have received numerous messages from our loyal base of shareholders and I can attest to having read them <unk>.
Speaker Change: 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.
Speaker Change: Thanks, everyone for your time today, we will now open the call for your questions.
Steven Lo: We've been asked that, you know, these, these conversations are, are, you know, I think at a point where You know, we're not able to share because of the fact that we want to respect our contract with BARDA as well as our relationship with them. But, you know, certainly we believe that they were productive and it could be one of the reasons why the soft work order was lifted. Thanks. I do want to add that we. We only know about our program and what's been publicly announced. We don't have any information about other programs beyond that.
Speaker Change: Thank you if you would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: <unk> Chan will indicate your line is in the question queue.
Speaker Change: You May press Star, Canada to remove your question from the queue and for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star.
Speaker Change: One moment, while we poll for questions.
Chang Lee: Our first question is from Chang Lee with Oppenheimer and company. Please proceed.
Speaker Change: Oh, hi, good afternoon, thanks for taking the questions and congrats on the progress and best of luck to you in your future endeavors.
Unknown Executive: just for everyone's clarity.
Unknown Executive: A question on the neurovirus.
Speaker Change: Maybe like two questions from me one on COVID-19, and Diablo norovirus.
James Cummings: 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. If this is the case, Why was the decision made to use a lower dose? for the phase one clinical trial.
Speaker Change: For COVID-19 program I'm, just curious any color you can share on.
Speaker Change: The gating factor to start patient dosing I think you mentioned in your <unk>.
Speaker Change: We expect dosing to start in the second quarter.
Speaker Change: And also how fast things can complete enrollment of the 10000 participants in the phase II B study.
James Cummings: James, if you could cover that. Sure. Thanks, Ed. So the dose we used in our previous Phase 2 trial was a 1E11 per strain dose. Don't forget this is a bivalent vaccine, so there's... And it was based on safety and immunogenicity data from the previous. We intend in this study to compare the 1E11 dosage of a legacy vaccine with both a low, a 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.
Speaker Change: On the Norovirus program.
Speaker Change: Can you help us set the.
Speaker Change: Expectations for the Fayetteville Rethought, how would how would you define a positive study. Thank you.
Speaker Change: Great Hi, Chuck Steve. Thank you very much for the questions.
James Cummings: On your COVID-19 question I'll make a few comments and then I'll turn it over to James as well on Norovirus I think both Sean and James can take.
Speaker Change: Take that so.
James Cummings: As it relates to the gating factors.
James Cummings: First of all we are 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.
James Cummings: So we're conducting this study to determine the best dose to provide us with the best chance of enhancing efficacy and similar safety.
Sean Tucker: Over. Thanks, James.
James Cummings: With including the screening of patients et cetera. So.
Sean Tucker: 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? 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, when we're done with the results, we'll publish them when they're available.
James Cummings: Those are the natural next steps in the study and once we get to.
James Cummings: To check off some of those steps our hope is that we'll be given the green light to start dosing I'll turn it over to James if he wants to add some additional details behind that.
Speaker Change: Sure. Thanks, Steve So in terms of the duration of enrollment for this study.
Speaker Change: I'd say approximately five to six months I say approximately because we will 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 over.
Sean Tucker: and a science question for Sean. HHS recently directed $500 million 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? 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 Change: Great and then chunk, but 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.
Speaker Change: Yes that and then James do you want to add yes, I think from our standpoint, I think success would be that the new constructs are trending better than the old contracts, we did not.
Speaker Change: The study is not enough to slip for statistical significance, but we do expect that the new contracts will do a little bit better on key immunogenicity endpoints.
Speaker Change: And I would concur I think and we're basing.
Speaker Change: Moving forward with that study based on some of the preclinical data that's compelling.
Speaker Change: Look forward to having that data top line data sometime mid year.
Phillip Lee: We'll move on from our programs to financial questions. for Steve.
Speaker Change: We're certainly very interesting.
Sean: Thanks, Sean Yes, we're certainly pleased that we were able to complete the enrollment.
Phillip Lee: 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 Change: As fast as we could to really get to that milestone.
Sean: Yes, thanks for all the color.
Speaker Change: <unk>.
Our next question is from Matt <unk> with B Riley Securities. Please proceed.
Phillip Lee: 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 $460.7 million as of today. Importantly, of that $460.7 million, really $240.1 million is currently available for payment. And then as disclosed in today's press release, the company has actually already received $85.6 million of cash payments through March 31, 2025.
Matt: Hi, Yes, good afternoon, and thanks for taking my questions.
Patients to fill and look forward to working with John.
Speaker Change: Yes, just maybe following up on the Covid program.
Speaker Change: The specific buyback correspondence that youre, having baidu.
Speaker Change: Adding those in.
Speaker Change: The <unk> case of the trial.
Speaker Change: There has been any learning from the Sentinel cohort.
Speaker Change: That is informative to these discussions and maybe also if you could comment on how you may want to handle the.
Phillip Lee: So what does that mean for Vaxart? Well, a vast majority of these payments that Vaxart receives are actually used to pay the vendors to run the COVID-19 phase two B 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 cashing to the first quarter of 2026. 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 Change: The results from the central and cohort.
Speaker Change: And later part of this year and then I'll follow up on your life.
Speaker Change: Okay, Great Yeah, I'll, let James.
Add some more details here.
Speaker Change: He was saying earlier the.
Speaker Change: Conversations have been really productive.
Speaker Change: I think we do incorporate.
Speaker Change: All of that we learned from enrollment.
Speaker Change: <unk> et cetera, and as well as how we ship.
Speaker Change: <unk> as well as our product to the different sites. So that's certainly been.
James Cummings: Something that we continue to build upon let me turn it over to James in terms of specifics with the study.
Phillip Lee: Thanks, Phil.
James Cummings: Thanks, Steve.
Phillip Lee: One other financial question for you. Did you raise money off the ATM that you put in place in March? 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 million by selling shares in the open market.
Speaker Change: After now that we are off the pause and we are currently activating or reactivating study sites and screening individuals'.
Speaker Change: That's really your first steps prior to enrollment and dosing and we've we've activated 20 sites and we screen to approximately 199 folks are in screening right now.
Speaker Change: That process and.
And 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.
Phillip Lee: 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. So since we've put the ATM in place in March, we have not sold any shares through the date of this call.
Speaker Change: Sorry, My question was around the.
Speaker Change: Sentinel cohort that 400 subject because that data could be helpful.
Phillip Lee: If I could just summarize there, really just no equity financings or dilution related to financing have really occurred since the last earnings report.
Speaker Change: And in many ways, including the alpine enrollment teams if you could maybe comment on that.
Speaker Change: Sure. So I would say that we intend to engage with our partners at BARDA to determine if.
Steven Lo: We'll move on to questions around the reverse stock split. And these are for Steve.
Speaker Change: Some sort of interim analysis with that group would be mutually advantageous to both parties.
Steven Lo: So first, what went into the decision to keep the authorized share count unchanged? Can that be amended prior to the annual meeting?
Speaker Change: The study is set to conclude in terms of the 12 months of safety follow up.
Steven Lo: 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 received a lot of questions there and really want to acknowledge that and that we understand your concerns there. Given where we are in the we did look into how we could amend the proposal. 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 Change: By December of this year, we are blinded as well. This is a double blinded study. So currently I can't give you any color further than that.
Speaker Change: Thank you and then above the recent DSM data review for Neuro latest trial could you touch on maybe what items with no debt and also if you could comment on.
What we saw in your recent phase on the publication and then dive back is that is coming together.
Speaker Change: If you want a highway end of phase II meeting.
Speaker Change: And some of the prior generation.
<unk> data will also be relevant to be engaging the regulators could you maybe put put all that together how youre planning to do that end of this year.
Steven Lo: We know it's important to you. From our standpoint as well, it's not our intent to, as Phil mentioned, have a lot of dilution in our stock. We will look into this and certainly have an update whenever we can.
Speaker Change: Thanks for taking our questions.
James Cummings: Sure James.
James Cummings: Provide some detail there, but just in terms of from a.
James Cummings: Interaction with the FDA I think we've said in the past right. If you look at the totality of the data. So all of that's incorporated but James feel free to add some more color.
Steven Lo: Thanks, see you. Um...
James Cummings: Thanks, Steve So in terms of.
Steven Lo: 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?
James Cummings: Our SM senior safety monitoring committee for the board.
James Cummings: For that phase one what we were looking at serially at safety to ensure that we see a clean safety profile with no areas of concern to move forward with the protocol as designed in Britain and safety.
Steven Lo: 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 a dollar. 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. And the board had a wide range to maximize flexibility.
James Cummings: Safety data was reviewed.
Following completion of.
James Cummings: The low dose cohort and then after some central members of that higher dose cohort again.
James Cummings: No.
Along with our entire platform, we see consistently.
James Cummings: Safety profile that is very similar to placebo.
James Cummings: For details in terms of the phase one Sean do you want to comment on your thoughts in terms of the immunologic.
James Cummings: Outcomes there over.
James Cummings: Sure.
James Cummings: After completion of the challenge study, we were able to identify a couple of key immune parameters that we thought were important the.
Steven Lo: With that said, we at present don't have the attention 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.
James Cummings: The first of which is looking at essentially.
James Cummings: Functional antibodies in Sierra as well as vehicle Iga responses, we will measure both of these parameters the new study at our at our hope based on our preclinical work is.
James Cummings: That the new contracts will trend better than the old construct.
James Cummings: <unk>.
James Cummings: Thank you.
Speaker Change: Our final question is from Roger song with Jefferies. Please proceed.
Speaker Change: Hi, This is ray on for Roger.
Speaker Change: Thanks for taking our questions.
Speaker Change: Congrats on the progress so I guess a couple questions from US first of all does the Covid program. So.
Speaker Change: No wonder what's what's the.
Steven Lo: 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? 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 a dialogue about extension until after the June 30th deadline. And this is why we want to have the optionality.
Speaker Change: Desktop alter what what's the impact on your.
I expect that the timeline to complete a study regarding maybe quickly remind us where you.
Speaker Change: Are you conducting the study.
Speaker Change: No.
Speaker Change: And how do you think about the seasonality there and then non coal.
Speaker Change: The norovirus program so.
Speaker Change: Understanding that the phase two will probably pending potential partnership so any active conversation that is ongoing.
Speaker Change: Right now thank you.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Thanks for the question.
Speaker Change: I'll go ahead and chat briefly about the stop work order and then James can add his perspective and then we'll go into the partnership question. So number one I think we were very pleased that.
Steven Lo: 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 Change: When we receive a stop work order on February 21st It was for 90 days and the fact that it was lifted within 60 to 62 days afterwards.
Steven Lo: Thanks. And I think we'll end on this question, which I know some of our shareholders have. have really wondered about, which is why don't you just delist from NASDAQ and trade on the OTC market? Thanks. And yes, that's a frequent comment. And you know, we've investigated this, we've looked into it as well. And from what we can see, a delisting, delisting from NASDAQ would have a significantly detrimental impact on the value of our shares. When a company is traded on an OTC market, liquidity is quite much lower, which could also negatively impact the stock price.
Speaker Change: Certainly.
Speaker Change: <unk> exceeded our expectations because we thought we would go the full 90 days.
I think as well to your question right. There there was 60 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 that James if you want to just cover anything from an enrollment standpoint and projections.
Speaker Change: Sure so.
Speaker Change: As part of as part of the study the staff work.
Order or the pause did impact that 10000 person cohorts of this study, but we continued with the 400 person Sentinel study they had already been dosed.
Steven Lo: 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 are, 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, you know, we have a good relationship with them. So, you know, 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 Change: And observing them for safety and that continues that 400 person Sentinel group as I mentioned should conclude the clinical follow up and December of this year and then project out after on blinding analysis of samples cleaning of data or.
Speaker Change: Three to six month timeframe in terms of some data there in terms of the 10000 person cohort. Once we began dosing I would project and this is a prediction about a six month enrollment period.
Speaker Change: 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 Theres. A 12 month follow up period, where we're looking at safety and Immunogenicity, but also efficacy both from a symptomatic standpoint.
Edward Berg: Thank you, Steve. That's all the questions we have at this time. Operator, can you close the cell? Thank you. This concludes today's conference. You may disconnect your lines at this time and thank you for your
Speaker Change: Someone who has symptoms and comes in to be screened to see if they actually have the Sars cov, two virus and COVID-19 infection as well as asymptomatic surveillance that will occur.
Speaker Change: For 12 months after they've received either our investigational.
Speaker Change: Vaccine construct or the improved vaccine and I think that's very interesting from the way that COVID-19, the Sars Cov two virus operates because it mutates overtime and so we will take a look at not just the protective efficacy, but also take a look at.
Speaker Change: What types of viruses may have mutated.
Speaker Change: <unk>.
Speaker Change: May not be as good for direct ITG response, but we feel our mucosal response should potentially have an advantage.
Speaker Change: Sure.
Speaker Change: Great.
Speaker Change: Leon.
Speaker Change: This is Steve I'll go ahead and address your question on Norovirus partnership discussions right. So number one we see norovirus is a very important opportunity right. There is an unmet need here, we're very well aware of many companies who are pursuing.
Speaker Change: Norovirus as well, so I think thats a promising market.
Speaker Change: As well as the fact that there are many companies out there that don't have a norovirus vaccine in their portfolio and certainly if you're.
Speaker Change: A large global multinational company that is something that could be desirable.
Speaker Change: We are having discussions with a.
Speaker Change: A broad and diverse range of companies.
Speaker Change: And like I said they include some of the large multinational companies some medium sized companies as well.
Speaker Change: These companies are both global as well as.
Speaker Change: Some regional players that are in the United States, but also outside the United States.
Speaker Change: I think everyone is.
Speaker Change: Waiting like we are for the top line results, which we've guided everyone to mid year of this year. So I think upon those results.
Speaker Change: Our expectation that those discussions will accelerate.
Speaker Change: 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 Change: Very helpful. Thanks for the additional color.
With no further phone questions I would like to turn the conference back over to Ed Berg for a written question portion of the cloud.
Speaker Change: Thank you operator.
Speaker Change: I want to thank our shareholders, who have submitted quite a number of.
Speaker Change: Written questions and.
Speaker Change: They.
Speaker Change: The questions were around both our programs.
Speaker Change: Our science financial matters.
Speaker Change: And our proposed reverse stock split.
Speaker Change: So we will handle the questions in that order.
Steve: The first question is for Steve.
Speaker Change: Around our Covid program.
Speaker Change: Since you are currently the only company.
Speaker Change: To get a <unk>.
Speaker Change: Stop work order lifted for project Nextgen.
Speaker Change: Can you elaborate on your conversations with BARDA and HHS.
Speaker Change: Yes. Thanks.
Speaker Change: So first of all as I stated earlier, we are grateful and thankful that we have the stop work order.
Speaker Change: Lifted.
Speaker Change: And I think that's the result of some productive conversations that we had with BARDA.
Speaker Change: BARDA and HHS to her that.
Speaker Change: Throughout that process, they certainly evaluated our program.
Speaker Change: The merits as well as on the science.
Speaker Change: From our standpoint. These are productive conversations that I'm sure everyone will respect that they also need to be confidential we've been asked that.
Speaker Change: These conversations R R.
Speaker Change: At a point where.
Speaker Change: We're not able to share because of the fact that we want to respect our contract with BARDA as well as our relationship with them, but certainly.
Speaker Change: We believe that they were productive and it could be one of the reasons why the soft work order was lifted.
Speaker Change: I do want to add that.
Speaker Change: We only know about our program and what's been publicly announced we don't have any information about other programs beyond that.
Speaker Change: Just for everyone's clarity.
Speaker Change: A question on the neuro virus.
Front from the.
Speaker Change: Shareholder.
Speaker Change:
In the norovirus trial, Youre testing, a low dose and high dose and have mentioned dose specific responses in prior trial results. If this is the case why.
Speaker Change: Why was the decision made to use a lower dose for the phase one clinical trial and James if you could cover that.
James Cummings: Sure. Thanks, Ed.
Speaker Change: The dose we use in our previous phase II trial.
James Cummings: 111 per Stratos don't forget this is.
James Cummings: Our bivalent vaccine so theres two strengths and it was based on safety and Immunogenicity data from the previous trials.
James Cummings: We intend and in this study to compare the 111 dosage of the legacy vaccine with both a low of $1 10, and a high 111 dosage strength of our second generation Norovirus candidate. This is going to allow us to choose the correct dosage moving forward and dose ranging studies are really best practice.
James Cummings: As 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.
James Cummings: Over.
James Cummings: Thanks James.
James Cummings: We have.
James Cummings: Question for Sean.
James Cummings: On avian flu.
James Cummings: The avian flu preliminary results appear very promising how quickly can the candidate enter the clinic.
James Cummings: Right now we're still in preclinical.
James Cummings: Our investigations, we have some other things coming up.
James Cummings: Obviously, we do think that our candidates can be manufactured very quickly and right now where we are getting ready to prepare.
James Cummings: Drug product for many for clinical use obviously, when we're ready with the denim with the results we will publish them when they are available.
James Cummings: Thanks.
James Cummings: And then in the science question for Sean.
James Cummings: HHS recently, directed 500 million 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 Vacs Arts.
James Cummings: And do you see the cross reactivity of <unk> vaccine as on par with theirs.
Speaker Change: But we are certainly appreciate that HHS is investing money and 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.
Speaker Change: Another thing is we believe our ability to generate cross reactive Iga may be beneficial for flu as well as for other indications.
Thank you.
Speaker Change: We'll move on from our programs two financial questions.
Speaker Change: For Steve.
Speaker Change: Sorry for Phil.
Speaker Change: You have received funding from the government.
Speaker Change: And you could be receiving more under this award.
Speaker Change: And use that money to fund the operations of the company.
Speaker Change: So I think the best way to address this is really by starting with stadium a few of the key financial terms of the award.
Speaker Change: The first one is that it does provide funding for up to $467 million as of today.
Speaker Change: Importantly of that $467 million really $240 $1 million is currently available for payment.
Speaker Change: And then as disclosed in today's press release, the company has actually already received $85 $6 million of cash payments through March 31 2025.
Speaker Change: So what does that mean for vacs are well a vast majority of these payments <unk> received are actually used to pay the vendors to run the COVID-19 phase two b trial.
Speaker Change: There is a portion of this award that covers a portion of our overhead as well as a fee paid to backstop for conducting this trial. So we do actually use that portion to help cover.
Speaker Change: Operations of the company and that is actually considered in our current cash runway guidance of cash into the first quarter of 2026.
Speaker Change: I think I'd also like to.
Speaker Change: To reiterate that like any other government contract the full operations of the company are not funded by this award.
Thanks, Phil.
Speaker Change: One other financial question for you.
Speaker Change: Did you raise money off the ATM that you put in place in March.
So for those are on the call just arent actually aware, we did file or an at the market. So that's otherwise known as an ATM offering in March of this year.
Speaker Change: So by following for the ATM allows that start to have the option, but not the obligation to actually raise and in our case up to $50 million by selling shares in the open market.
Speaker Change: 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 Change: So since we've put the ATM in place in March we have not sold any shares through the date of this call.
Speaker Change: If I could just summarize there really just no equity financings or dilution related to financings have really occurred since the last earnings.
Speaker Change: Report.
Phil Lee: Thanks, Phil.
Speaker Change: We will move on to questions around the reverse stock split.
Speaker Change: 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 Change: So first of all what I want to do is acknowledge and thank.
Speaker Change: All of 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.
Speaker Change: Acknowledged that and that we understand your concerns there.
Speaker Change: 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.
Speaker Change: Concerns, we're looking into and evaluating how best to address this.
Phil Lee: In time for the annual meeting we know it's important to you and from our standpoint as well, it's not our intent to as Phil mentioned.
Speaker Change: Yeah.
Speaker Change: Do a lot of them have a lot of dilution in our stock so.
Speaker Change: We will look into this and certainly have an update whenever we can.
Speaker Change: Thanks, Steve.
Speaker Change: I'm going to shift to a related question.
Speaker Change: Are you planning to revise the reverse stock split to a more reasonable level.
What goes into determining the ratio the split if approved.
Speaker Change: Yes, so when we first started working on this end.
Speaker Change: So wanted to just.
Speaker Change: Update folks that in our.
Speaker Change: Filing with NASDAQ to stay in compliance were in the second six months of that and part of that requirement to.
Speaker Change: Regain compliance in our discussions with NASDAQ is the fact that we do have to show a plan on.
Speaker Change: Above a dollar and that actually includes the.
The fact that we have to look at a reverse stock split so that was the first step the next step was.
Speaker Change: Let's look at a range that.
Speaker Change: Could make sense and we had the board had a wide range to maximize flexibility with that said we are present don't have the intent attention of trying to affect a reverse split in the 1% to 50 ratio as I mentioned in one of the recent stockholder.
Speaker Change: The 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.
Speaker Change: Obviously, we prefer not to have to do that.
Speaker Change: Through the achievement of our important milestones and continued execution.
Speaker Change: 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 Change: Thanks, Steve.
Speaker Change: And another question its compliance isn't regained in time are you preparing to appeal to Nasdaq.
Speaker Change: For an extension.
Speaker Change: Especially considering the recent program pause.
Speaker Change: Sure. So as I was saying earlier when we receive the second six month extension from NASDAQ.
Speaker Change: It was contingent upon our company, having a plan to affect a reverse stock split. So it is part of the process, which is why we are putting the vote forward to our shareholders.
Speaker Change: We have been informed by NASDAQ that they do not engage in a dialogue about extension until after the June 30 deadline and this is why we want to have the optionality.
Speaker Change: 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 Change: Thanks.
Speaker Change: And then I think we'll end on this question, which I know some of our shareholders have.
Speaker Change: Yes.
Really wondered about which is why don't you just delist from NASDAQ and trade on the OTC market.
Yes.
Speaker Change: Frequent comment and we've investigated as we looked into it as well and from what we can see a delisting delisting from NASDAQ would have a significantly detrimental impact on the value of our shares when.
Speaker Change: Our company has traded on an OTC market liquidity is quite.
Speaker Change: Much lower which could also negatively impact the stock price.
Speaker Change: As you May know, many brokerage firms and investment funds really steer clear of the lower price stocks in companies that are not on a major exchange, which could also discourage other potential investors.
Speaker Change: The restrictions that come with trading on a less prominent exchange could also deter the institutional investors and so we.
Speaker Change: Art.
Speaker Change: We don't really desire being on that type of an exchange because it could also result in <unk>.
Speaker Change: Dropping our research coverage by our covering analysts who have been very supportive and.
Speaker Change: We have a good relationship with them so.
Speaker Change: 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 Change: Thank you Sir that's all the questions. We have at this time, operator can you close the sale.
Speaker Change: Yes. Thank you. This concludes today's conference you may disconnect. Your lines at this time and thank you for your participation.