Q4 2023 Vaxart Inc Earnings Call
Participants
Ed Burke; SVP and General Counsel; Vaxart, Inc.
Michael Finney; Interim CEO; Vaxart, Inc.
James Cummings; CMO; Vaxart, Inc.
Sean Tucker; SVP and Chief Scientific Officer; Vaxart, Inc.
Phillip Lee; CFO; Vaxart, Inc.
Charles Duncan; Analyst; Cantor Fitzgerland LP
Roger Song; Analyst; Jefferies Financial Group, Inc.
Mayank Mamtani; Analyst; B. Riley Securities
Presentation
Operator
Yes, greetings, and welcome to the Vaxart business update and full year 2023 financial results conference call. Question-and-answer session will follow management's opening remarks. Individual investors may submit written questions to ir.vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, [Ed Burke], Senior Vice President and General Counsel.
Ed Burke
Yes, good afternoon, and welcome to today's call. Joining us from Vaxart are Dr. Michael Finney, Interim Chief Executive Officer; Dr. Sean Tucker, Chief Scientific Officer; Dr. James Cummings, Chief Medical Officer; and Phil Lee, Chief Financial Officer. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the Company's financial results, financial guidance, its future business strategies and operations, and its product development and regulatory progress, including statements about its ongoing or planned clinical trials.
Actual results could differ materially from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the Risk Factors section of XR, its most recently filed annual report on Form 10 K and also on other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Dr. Michael Finney. Mike?
Michael Finney
Thanks, Ed. And thanks to all of you for joining us today. It's a pleasure to be speaking with you at this exciting time in the company's development. As this is my first quarterly call with you. I will begin with a brief introduction of myself and my observations of our company, then I'll transition the call to the rest of the team to move to our recent accomplishments, clinical programs, upcoming planned milestones and full year first, this is my second installment is XRCEO., having served in a similar capacity from 29 to 2011 has been Ivax, our Board member since 27 and Board Chair since March 2023.
Throughout my time effects are seen the company go through many periods of clinical and corporate growth and take on a variety of new challenges. Never have. I been more confident in our team and in our trajectory than I am right now. I firmly believe 2023 was a transformational year for this company and our Mako cell technology. We made solid progress on our oral vaccine platform, completing two Phase two clinical studies for our norovirus oral vaccine candidate. And we have now established proof of concept to challenge studies for both respiratory and GI viruses.
Based on the totality of the data we've produced through these and our other reported clinical trials, I think it's clear that what we have our hands on our oral pill vaccines hold a very real promise of offering several advantages compared with injectables, including the ability to vaccinate people faster, easier and painlessly without the need for cold chain storage or trained medical professionals to administer the vaccine as well as the promise of mucosal immune response. We've already determined in preclinical and clinical trials. Better candidates have a favorable immune profile, reduced serum antibody and serum neutralizing antibody responses induced potent T cell responses, create mucosal immune responses and can inhibit viral shedding, which may have an impact on virus transmission.
Looking at the current landscape and particularly given our recent ARDA contract award, we are now poised to make some major strides forward with our COVID-19 program. James will go over the details of the preparations and the study design. It is clear that the federal government believes need better vaccines that harness the power of mucosal immunity, more strongly combat the current XPV and future variants of the virus, the first generation of vaccines.
Let's start with the virus is continuing to evolve. We can do much better, in fact, starting to prepare to accept that challenge and demonstrate our technologies pump. At the same time, we're making steady progress on our norovirus program. We've completed our analyses, the recent challenge study data and have identified a potential correlate of protection, which will inform our upcoming meeting with the FDA to discuss the optimal path forward for this program. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development principle formulated for oral administration and designed for delivery to that, yes, norovirus carries a tremendous economic burden in this country and globally, and we look forward to creating an oral vaccine that uses this burden for millions of society's most vulnerable.
Finally, I can say with great pleasure that last week we announced the appointment of a permanent President and Chief Executive Officer, Steve Lo. Steve brings a wealth of biopharm experienced of XR with more than 25 years in health care, biotech and pharmaceuticals, including more than 12 of those years in the C-suite, had a particular focus on development and commercialization having helped two companies bring their first product. Maxar is in a tremendous position to advance its mission. We are excited to add a high caliber experienced CEO. elevate this company to greater heights and create value for our shareholders. And currently, I will be stepping down as CEO and retaining my position as Chair of the Board. He joins Vaxart effective March 18th, and we are thrilled to welcome you. And I'll now turn over the call to James to review the recent progress for our coronavirus progress.
James Cummings
Thanks, Mike. First, I wanted to thank our clinical, regulatory, CMC and research teams who've worked tirelessly for nearly four years on our COVID-19 program. Their perseverance and dedication to our cutting edge research have been crucial and laying the groundwork for this program's recent progress. All of us here at Praxair were encouraged in January to receive a $9.27 million contract from Barda to prepare for a 10,000 subject Phase IIb clinical trial evaluating our company's oral pill, XB., the COVID-19 vaccine candidate against an approved mRNA vaccine comparator. This award is part of the federal government's project next gen effort to boost our nation's pandemic preparedness and improve upon our collective ability to combat COVID-19.
Vaxart is one of only a handful of companies to receive funding from Barda to date to prepare for a Phase IIb clinical trial under this very important initiatives. We are heartened by the government support, which we think is indicative of the potential of our differentiated approach to the continuing challenge that is COVID-19. This support will empower back start to move forward with our oral COVID-19 program. Currently, we are engaged in preparations to initiate this Phase IIb trial. This trial, which may start as early as Q2 in 2024, is a Phase IIb double-blinded, multi-center, randomized comparator, controlled clinical trial to determine the relative efficacy, safety and immunogenicity of Acthar's investigational oral SRCOB.
Two SBB. vaccine tablet against the currently approved mRNA COVID-19 needle injected booster vaccine in adults previously immunized against COVID 19 infection. As we continue our clinical trial preparations, we're working to secure additional funding, which would support the initiation and conduct of the Phase 2b study, we will provide the timing and amount of any additional funding as events warrant commensurate with additional funding. We hope to be among the first of the project next-gen recipients to initiate our Phase IIb head-to-head clinical trial.
Last month, we continued to demonstrate the cross protected potential of our COVID-19 vaccine candidates with the publication of previously announced data in the Journal vaccines. This preclinical non-human primate data showed that our vaccine candidates could protect against multiple source COV. two variants of concern assay elicited strong antigen-specific serum IgG and IGA responses with neutralizing activity. Vaccination also reduced stars Coby two shedding following infectious challenge in both the upper and lower airway of non-human primates publications and highly respected journals such as vaccines are really important because they continue to show that our groundbreaking research is being recognized by the scientific community.
These data also serve as the foundation for our current COVID-19 vaccine candidate, which will be evaluated during the upcoming Phase IIb clinical trial. Banksource, vast platform and technology has great potential. We believe this platform could transform the landscape not only for COVID-19 vaccines, but also for other infectious diseases that present significant threats to global public health, such as norovirus and influenza. We're very proud of our entire team as we continue to lead the way and mucosal vaccine clients. I'll now hand the call over to Dr. Sean Tucker, our Chief Science Officer and Founder, for an update on our norovirus vaccine program. Sean?
Sean Tucker
Thanks, James. We made significant progress in our norovirus program in 2023, delivering top line data from two Phase two studies, including a challenge study of RG. one one monovalent candidate. We have evaluated most of the data and we built and we believe we are on track for identified potential correlates of protection that will aid in the advancement of our Biovail norovirus candidate. We believe the data we have shared to date is promising for this vaccine candidate and for our vaccine platform. Overall, late in the fourth quarter, we completed enrollment of our Phase one clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in lactating mothers, breast milk and transfer those antibodies to young infants.
Recall that this study is being supported partially by the Bill & Melinda Gates Foundation. This Phase one, multicenter, randomized double blind, placebo-controlled dose-ranging study is designed to evaluate the safety, tolerability and immunogenicity of our oral administered five L & G one one G to four vaccine in healthy lactating females of at least 18 years of age to study enrolled 76 subjects at five sites in South Africa. These subjects were randomized into higher low-dose vaccine or placebo. Primary endpoints for the study is frequency duration and severity of solicited symptoms. One week following the study drug dose, the frequency, duration and severity of unsolicited treatment, adverse events, serious adverse events, adverse events of special interest and new onset of clinical illness through the active period in particular and what's most exciting is that this This study will look for DP. one specific IgG1 and IgG for IGA in the serum and in the breast as well.
We are currently expecting to announce top line results from this Phase one trial in mid 2024. Going forward, we plan to meet with the FDA during the second quarter of 2024 to discuss our data on potential correlates a Phase IIb dose confirmation study and potentially a G. two for challenge study. We currently believe that G. Phase IIb study will generate sufficient safety data to have an end-of-Phase two meeting with the FDA. An end-of-Phase two meeting will allow us to gain concurrence with the FDA on the scope and design of a Phase three pivotal efficacy study in adults over 18 years of age. That said, the type and timing of our next clinical study will be determined following our meeting with the FDA in Q2. We plan to provide an update on the next steps for this program as soon as we are able to after that meeting. I'll now hand the call over to Phil Lee, our CFO, for a brief discussion of our financials. Phil?
Phillip Lee
Thank you, Sean. The details of our financial results for the full year 2023 are summarized in today's press release, revenue for 2023 was $7.4 million compared to $0.1 million in 2022. Revenue in 2023 was primarily from revenue recognized. Our work performed under Vaxart strength from the Bill & Melinda Gates Foundation and non-cash royalty revenue from increased sales of Indivior Japan back to our ended 2023 with cash, cash equivalents and investments of $39.7 million.
This cash balance does not include approximately $15 million net proceeds raised in early 2024. That's our anticipated current cash runway into fourth quarter of 2024. Thank you all for your time today. We will now open the call for your questions.
Question and Answer Session
Operator
(Operator Instructions) Charles Duncan, Cantor Fitzgerald.
Charles Duncan
This is Assia on for Charles. We have a question regarding the lactating mothers study. Can you talk about possibly what you would like to see from this Phase one study that could further differentiate. So oral norovirus, still target product profile and possibly supporting approval in the future. Thank you.
Ed Burke
Sean, do you want to handle that one?
Sean Tucker
Yes, I'll start and then let James jump in. Yes. I mean, the key thing about this experiment or I should say this clinical study is by giving the vaccine to lactating mothers. We hope to see the antibodies in the breast milk and those vast milk antibodies will be transferred to young infants. As you might understand, I know that you know what are the main, I should say, young children are probably the most susceptible to norovirus infection and by getting the antibodies into kids.
But there will be a vast breast milk. We think that's going to have a big impact. We hope that this not only by protecting the mother and the kids, we can also protect, you know, essentially by if these antibodies are going to be very good and great efficacy. We could also have a lot of ability to block transmission to other people in the community. James, do you want to add anything.
James Cummings
Thanks, Sean. There's a rich history of maternal immunization to assist with covering children. But I think the the interesting thing about our vast platform is it does such a compelling job on mucosal immunity and on IGA production. So taking a look at those levels in the breast milk in a more formalized way and then taking a look at and potentially how the children do with Crestmark laden with maternal antibodies should go a long way to bettering our understanding of how this platform could work to potentially impact to that pediatric population
Operator
Roger Song, Jefferies.
Roger Song
Where I think you are this is a downturn on Roger Song. So we have a couple of questions. So I guess maybe the first one, could you remind us of the economics of the data next gen funding? And how would that impact your runway down to the year? And then I have some follow-up questions. Thank you.
Ed Burke
Well, Varda contract we announced in January provides funding to prepare for a Phase IIb COVID-19 trial. We can't speculate about Bard as award process or timing of other of other companies have announced that their group, they were subject to an option agreement with Barta where bardo might provide something in the neighborhood of $400 million to come to execute on the contract. And we believe that as we execute against the milestones in this contract, we'll be in a position to receive additional funds. And the details are not things that we can do. We have any ability to talk about right now. We'll provide an update as we gain additional visibility Sure.
Roger Song
Thank you on. So my next question, it's part of the protection correlates. So I'm wondering, you know, how how would that protection correlate impact your Phase three U.S., but the plan?
Ed Burke
Sean, I think you're the expert on that.
Sean Tucker
Yes, I'm going to I'll start and again, I'll let James follow it all along. I think the key thing about understanding what immune parameters are important for is good for a variety of reasons, but one of the things is that if you have an established correlative protection of your vaccine, so you know, that this measure in this immune parameter leads to protection, it could lead to a reduction in the amount of subjects that you need to test in a Phase three efficacy study because that correlate can be used essentially to understand what's protective and you can use it to bridge between different age groups. James, would you like to add to that?
Roger Song
Thanks, Sean. So here, we're very excited about the work that Sean and his team is doing there and know, as Sean had mentioned, no defining a correlate. It's an impressive piece of work with further discussion, there's a potential to consider that as a surrogate for protection. And as Sean mentioned, it would impact both to the numbers required for a clinical field study in Phase three as well as potentially the duration of time what that study would would go on looking at those immune correlate parameters and not just field efficacy. So some more to follow as we have that discussion in the near future.
Sean Tucker
Thank you, David.
Roger Song
I think you are maybe my last question is about the potential of the two GPORT. two for challenge study. So what would be some key considerations or discussions regarding the necessity of this?
Ed Burke
It And James, can you answer that?
James Cummings
Certainly So thanks, Roger. So I think that we'll gain a lot of information in our conversation with the agency. If they require additional information from an additional challenge, G to four would be a challenge study that could be performed. You know, it's something that we've looked into and adjusting case scenario if it is required and And if it's not, you know, it's off, right? I think we'll have a lot more clarity on if we are required to do an additional challenge study after we have that meeting with the agency.
Roger Song
Thank you, James. Got it. Got it. Thank you. I think that's it from us.
Operator
Mayank Mamtani, B. Riley Securities.
Mayank Mamtani
Hey, guys, on Madison. All Farmer Mac, congrats on the progress. And if I can ask a follow-up to a previous question in the event that you do have a G. two four challenge study. I'm just wondering how fast do you think you'll be able to get that study up and running? And then secondly, and unrelated, some do and maybe you mentioned I'm not sure for the border Phase two, will you be using a commercial grade material on your back there?
Roger Song
Yes, Mike, would you like me to go forward?
Michael Finney
I'm not sure yet of yes, WJ's, I sure will. So in terms of your second question first, I guess, and this said, this Phase IIb study it would be executed is just that it's a clinical trial under the auspices of the good clinical practice guidelines and rules and regulations from the FDA. So it requires a GMP manufactured material, which is what we use in all of our clinical trials. And so that I think that should square that away. The comparator vaccine will be an approved mRNA needle injected vaccine, and we'll be comparing the efficacy of both of those vaccines or Kent infections against one another.
We'll also be looking at safety. We we in our platform, have a very fortunately very clean safety profile, and we'll be comparing that to the solicited and unsolicited adverse events, both from our product, but but also from that needle based injection of an mRNA booster. And we'll be looking at that data as well, what was your second question?
Mayank Mamtani
And secondly, as a follow-up to the prior question, in the event after your meeting with the FDA in the event that you were to run a challenge study? Just curious how fast and you guys could initiate.
Michael Finney
Yes. Well, I think there's it just depends on what the guidance of the FDA really tells us, right. So I don't want to speak for the agency or make any assumptions until after we have that meeting. And that said, the good news is that there are groups that have been refining, what is that challenge model in the United States, so I think we could, in relatively short order move forward with, say, a challenge study. I can't be more specific than that until we have the dialogue with the agency.
Mayank Mamtani
Understood. Thanks.
Operator
Thank you. I would now like to turn the call back over to Ed Burke for further questions.
Ed Burke
Thank you, operator. We'll now turn to questions submitted by our shareholders.
So the first question is for Mike. Any incoming CEO, Steve low has had success in first product commercialization. Was that the five primary factor in your search for what other attributes would you consider and how would you make the selection?
Michael Finney
Well, regulatory and commercialization experience are, of course, important, but the Board was looking for an all round performer, and I think we found that risky.
Ed Burke
Thanks, Mike. Our next question, what is the timing for next steps for norovirus on timings following your FDA meeting in Q2. And James, I think you've answered some portion of this, but I'll turn to you.
James Cummings
Sure. So on timing and next steps will, as I mentioned, be dependent on the dialogue with the FDA, right. We'll assess at that time and look forward to providing an update to anyone really interested after we have that meeting. And there's the nice thing is there's a couple of ways we see looking at the impact of power. Our next step would be whether it's with the Phase IIb dose confirmation study from our safety data whether it's for us a challenge study that may be required or may not be required to give more information and quotes to protection. And then with the whole idea of looking down range two to a potential Phase three study. That's that's the goal.
Ed Burke
Thanks, James. Another question on norovirus. Will you be disclosing the results of your norovirus data analysis and the correlate of protection. Sean, I think this is yours.
Sean Tucker
I guess I'm obviously very excited about the work we've done. And of course, we will share our findings at the A. after we gather input and then will next assess the next steps for the program. And once all that's done, we also plan to submit a peer reviewed manuscript. And again, the timing of that will be determined at a future date.
Ed Burke
And John, next question, please elaborate on the preparations for your phase the Phase IIb COVID trial. When do you expect to complete preparations, James, I believe this is yours.
James Cummings
So yes, we've been coordinating with our colleagues at Barta, and we've done, I think, a great job in terms of moving forward at progressing with preparation for what is a really significant endeavor, a Phase IIb study of 10,000 enrollees. Once we have that completed, we will update you.
Ed Burke
Okay. Thanks. And that is all the questions we have at this time. So I want to thank everyone today for joining us.
Operator
And this concludes today's call.
Roger Song
Thank you.
Operator
Thank you, Ed, you may disconnect your lines at this time and have a wonderful day. We thank you for your participation.
