This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk08: and welcome everyone to the geovacs third quarter 2021 corporate update call i am rocco with chorus call and will facilitate today's call with me are david dodd chairman and ceo mark reynolds chief financial officer mark newman phd chief scientific officer john sharkey phd head business development and don diamond phd professor department of hematology and hematopoietic cell transplantation, City of Hope. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Jules Abraham of CORE-IR, who will provide a forward-looking statement regarding this call and information herein.
spk07: Jules Abraham Thank you, Rocco, and good afternoon, everyone. Please note the following. Certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether Geovax can develop and manufacture its vaccines with the desired characteristics in a timely manner, whether Geovax's vaccines will be safe for human use, whether Geovax's vaccines will effectively prevent targeted infections in humans, whether Geovax's vaccines will receive regulatory approvals necessary to be licensed and marketed, whether Geovax raises required amounts of capital to complete vaccine development, and there is development of competitive products that may be more effective or easier to use than Geovax's products, whether Geovax will be able to enter into favorable manufacturing and distribution agreements, and other factors over which Geovax has no control. Geovax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission, including those set forth at risk factors in GeoVax's Form 10-K. It's now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. David.
spk04: Thank you. Good afternoon. Thank you, everyone, for participating in the 2021 Third Quarter Update Call. We're pleased to have this opportunity to review and discuss our continued progress in accelerating our priority development programs towards clinical development and continuing to secure significant resources in support of GFX growth and development. We remain focused on delivering meaningful results and value milestones over the next 12 to 18 months, focused on our priority programs related to COVID-19 and immuno-oncology, developing increased value for shareholders, stakeholders, and public health worldwide. Over the past year, we strengthened our cash position while advancing towards important data milestones related to several of our programs. We remain pleased with the progress and outlook for Geovax. Over the past few weeks, we've announced the successful entry of clinical development within both immuno-oncology and COVID-19 vaccine developments. These successful milestones are consistent with our goal of accelerating clinical stage status within each of these strategic areas while providing a strong foundation for further developments of novel differentiated products within these critical medical areas. Since our recent Godeptan announcement, we've confirmed two additional clinical sites that initiated the IND transfer to our responsibility. Further expansion and acceleration of the Godeptin trial is underway. We're most excited about the outlook and promise of Godeptin within head and neck cancer, where it has received orphan drug designation from the FDA. In addition, there's promising opportunities relative to expanded use of the GDEP technology in conjunction with other therapies and in conjunction with our MVA-VLP tumor-associated antigen approach. Regarding the licensing of the Phase 2 COH04S1 vaccine program relative to COVID-19 and the expanded opportunities we expect in conjunction with our CMO2 program, we'll discuss those opportunities later in the call. In addition to the significant milestones achieved relative to gadeptin and O4S1, our programs related to hemorrhagic fever virus vaccines continue to successfully progress via non-diluted funding and support from the federal government. This is well addressed in our press release, noting the continued progress of these programs, especially through the suite of preclinical services from NIAID, for which Geovax's Sudan and Marburg vaccine candidates are being tested for immunogenicity and efficacy in the benchmark non-human primate model. Our vaccine against Lassa fever virus is in preclinical studies with funding support from the U.S. Department of Defense. We believe that our portfolio of hemorrhagic fever virus vaccines potentially offer a valuable addition to preventing these highly dangerous and threatening viral challenges. We look forward to continued reporting on the progress of these programs. Tuesday afternoon of this week, we announced the completion of an exclusive license pertaining to the COH04S1 vaccine, a phase two COVID-19 vaccine from City of Hope. a world-recognized research institution and NCI-designated comprehensive cancer center. The phase two clinical trial currently enrolling patients is the only one of its kind to prospectively study the safety and effectiveness of an investigational COVID-19 vaccine in blood cancer patients who have received a bone marrow transplant or CAR T therapy. O4-S1 utilizes modified vaccinia-ancra, or MVA technology, similar to our programs underway at Geovax. We anticipate significant synergy with and complement to our program, but this transaction propels us into a critical stage of clinical development. Created from a synthetic MVA, O4-S1 works by inducing immunity to SARS-CoV-2 by stimulating the immune system to produce antibodies against the virus that can block the virus from entering healthy cells. With O4S1, the immune system can also grow new disease-fighting T cells that can recognize and destroy infected cells. This product has already been tested for safety and potency in healthy volunteers and induces strong T cell responses. O4S1 is Also, the only COVID-19 vaccine to advance the phase two trials in cancer patients that includes both SARS-CoV-2 spike and nucleocapsid or the N protein. By inserting these proteins into the MBA delivery vehicle, the MBA is able to drive the expression of both proteins within the body of the vaccine recipient, spurring immunity against the virus. Giving O4-S1 after CAR T therapy may work better in reducing the chances of contracting COVID-19 or developing a severe form of COVID-19 in patients with blood cancer compared to the current vaccine options. This trial is also the first comparative study of an investigational COVID-19 vaccine with the FDA-approved Pfizer BioNTech vaccine in people receiving immunosuppressive therapy. For patients who are likely to have difficulty mounting an antibody response due to extended B-cell aplasia post-therapy, the T-cell response to vaccine will be critical. But now in order to delve deeper into O4S1 and this transaction, it's my pleasure to introduce Dr. John Sharkey, head of business development at Geovax. John?
spk01: Thank you, David. The transaction that was announced relative to COH04S1 provides a strong basis for propelling GeoVax's presence in the SARS-CoV-2 prevention market. A Phase II trial designed to evaluate the immunogenicity and safety of the multi-antigenic 0-4-S1 vaccine to the currently approved Pfizer-BioNTech mRNA vaccine in patients. Having recently undergone a hematopoietic cell transplant or CAR-T therapy, It's currently enrolling and strongly positions us in a market segment with significant unmet medical need. In addition, a planned Phase I-II trial to evaluate the immunogenetic response, pardon me, as a booster in healthy volunteers previously vaccinated with mRNA-based vaccines has the potential to expand the use of O4S1 into a significantly larger market segment. We believe the transaction we announced, which grants us exclusive worldwide rights to O4S1 vaccine, as well as the underlying SMBA technology for use in the field of COVID-19, significantly accelerates our development activities in the COVID-19 prevention market. Now, I'd like to pass the discussion to Dr. Don Diamond, Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, who led the development of this exciting product. Don?
spk03: Thank you. First of all, I'm delighted to be involved in this exciting new collaboration. My laboratory has been developing vaccines since the late 90s, but we consider COH04S1 our finest achievement. Let's discuss some data I brought along that illustrates some of the favorable properties of the vaccine. The key scientific breakthrough was the development of the synthetic platform shown on the slide. It is a virtual copy of the wild-type vaccine virus, MVA. As we published, the whole MVA genome was split into three pieces. And through sophisticated virologic science, all three pieces recombine into a circular viral DNA, as shown on the right, that is triggered to form an actual virus by another clever virologic method detailed in our published report and patent filings. To make COH04S1, the spike in nucleocapsid genes from the original Wuhan strain of SARS-CoV-2 were inserted into individual plasmid components, as shown in the slide. And once again, the three components recombined, and with the aid of a helper virus called FPV, to form COH04S1, our clinical vaccine. To investigate the properties of the vaccine, various preclinical models were evaluated as detailed on the slide. We illustrate pivotal protection studies in hamsters and investigations into non-human primates. All the work pointed in one very positive direction. We applied to the FDA for permission to conduct a phase one trial in healthy volunteers and were granted that permission. In this slide, we summarize the main objectives and outcomes of the clinical trial. We achieved the goal of developing a vaccine that elicited both humoral and cellular immunity, as shown on the slide. The immunity that we found was potent and had the right characteristics to be protective against SARS-CoV-2 infection and symptoms arising from that infection. Here we show some exciting data illustrating that at all dose levels, there is a strong response to the vaccine generating the main components of a successful immune response. Antibodies, neutralizing antibodies, and Th1 biased T cells observe the durability out to 100 days, 180 days for all of the illustrated parameters. These observations bode well for a solid protective response that will last beyond the 180 days we show here. The full observation period for each subject is one year. Here we show that all important neutralizing antibody responses against the variants of concern. This is synonymous with protective humoral immunity. Of note, the titers are more durable and of higher magnitude at dose level 2 and dose level 3 for the nasty beta variant. All of the data will be publicly available once we submit this study for peer review and the manuscript is accepted. Here are the results of ELISPOT that detect the good T cells, left panels, and the ones that are associated with disease enhancements. right panels. Note that the good T cells are durable out to 180 days, and the levels are still comparable or better to what other vaccines are eliciting. And the bad T cells never rise even after 180 days. What we are seeing at 180 days are memory T cells that fall from the apex but stabilize at levels that are reasonable for any chronic immune response. They don't disappear. Our recently FDA-permitted trial in our stem cell and CAR T cell recipients recently got underway. We think this will differentiate our vaccine from the other products by sustaining a T cell response in these very hard-to-treat patients who are still at high risk of severe COVID-19. We are excited to begin our first booster trial. We believe that delivering a different platform after multiple mRNA vaccines may cause more durable immunity that is long-lasting. We hope to open the trial shortly and expect rapid accrual. Now I'd like to turn the discussion over to Dr. Mark Newman, GEOVAX Chief Scientific Officer. Mark?
spk06: Thank you, Don. Obviously, my team and I are delighted to have the opportunity to work with Dr. Diamond and the City of Hope and to have the City of Hope O4S1 vaccine as what is now the lead candidate and lead clinical stage candidate for our SARS-CoV-2 vaccine portfolio. Not only will this vaccine move the GeoVax effort forward in the clinic, but there are also multiple other valuable synergistic aspects to this partnership, which I'm going to point out here. First, as noted by both Dr. Diamond and David Dodd, the City of Hope O4 S1 vaccine is based on the use of MVA. As you know from previous presentations, this is the viral vector modality of which is a foundational base of the GeoVax programs. Very comfortable with this and excited to work with a new variant. Second, the vaccine design is multi-antigen with both the SARS-CoV-2 S, or spike protein, and nucleocapsid proteins being expressed in the body as the vaccine immunogens. Again, you'll recall multi-antigen is our firm bias. The vaccine induces in both neutralizing antibodies and T-cell responses specific for the spike protein and induces antibodies and T-cell responses for the nucleocapsid proteins. This design concept was implemented specifically to induce the potency and to expand the immune response, specifically to better combat and clear infections, regardless of the circulating SARS-CoV-2 variants, as Dr. Diamond's data showed you. As we previously presented, the GEOVAX approach is also focused on the induction of immune responses. specifically immune responses specific to proteins beyond the S protein. As such, the city of Hope for S1 clinical stage vaccine represents an ideal initial step as the basis of next generation vaccines, specifically designed to augment and boost T cell responses. Finally, the ongoing Geovax effort to develop a manufacturing process that is based on a continuously growing avian cell line specifically to increase production consistency and capacity, will mesh very nicely with the clinical development plans and clinical development schedule associated with the City of Hope O4S1 vaccine. I think clearly the benefits of this transaction to the GeoVax program are highly significant and timely. Now I'm going to turn the presentation over to Mark Reynolds, the Chief Financial Officer.
spk05: Thank you, Mark. I'm going to go through much of this pretty rapidly. I know this is the original purpose of this conference call, but I think our focus clearly is on the development programs versus the financials. But anyway, starting with our balance sheet review, cash balances at September 30 were $18 million compared with just under $10 million at December 31st of last year. Working capital was $17.8 million compared to $9.4 million. And the increase, we've talked about this before, but the increase in cash balances was due primarily to our February offering, stock offering, with net proceeds to us of $9.4 million. Year to date, we've also received $3.4 million from the exercise of our publicly traded warrants. Those are traded under the symbol GOVXW. Turning to the income statement. I'm going to focus on the comparative figures for the nine-month periods of 21 versus 20. Grant and collaborations revenues were 220,000 during the 21 period versus 1.6 million in 2020. The 21 period revenues relate entirely to our grant from the NIH supporting our COVID-19 vaccine, while the 2020 amount includes revenues from our grant from the U.S. Army supporting the loss of fever vaccine program. That grant is continuing. We just have this timing of external expenditures on that. That grant will continue into next year. Research and development expenses were $2.7 million in 2021 versus $1.7 million in 2020, with the increase associated with license fees and warrant expense related to the in-license of the adeptum. expenses related to our COVID-19 vaccine program, manufacturing process development, and a generally higher level of activity. G&A expenses were $2.6 million versus $1.4 million. A large portion of the increase there relates to our annual Delaware state franchise tax, which is based on capitalization, but that amount was minimal in 2020. Other increases were in insurance premiums, patent costs, legal fees, consulting fees and personnel costs generally associated with preparing our organization for a much higher level of activity following our capital raises. Other income and expense for 21 includes a $172,000 gain on extinguishment of debt associated with the forgiveness of our PPP loan. And overall, the net loss for the nine-month period of 2021 4.8 million, or 80 cents a share, compared to 1.6 million of the prior year, or $2.85 per share, with the variance in the per share amounts primarily due to the dilutive effect of the offerings in September of last year and in February of this year. And a few notes on our capital structure. There are 6.4 million common shares outstanding. $1.8 million of the GOVXW publicly traded warrants outstanding. Those are exercisable at $5 a share. And if they are exercised in full, they could bring in another $9.1 million into the company's coffers. Our net cash flow from operating activities during 21 was nearly the same as our net loss, $4.5 million, with the addition of the Gidepton clinical program in September, and now the City of Hope COVID-19 clinical program our cash needs are obviously going to increase substantially, not only for the license fees and the direct costs associated with the clinical programs, but also for facilities, personnel, and other costs to support those programs. While we aren't providing any specific forward-looking estimates of costs to complete these research programs, what we can say at this time is that our existing cash reserves are sufficient to rapidly move these programs forward through mid-2022. And we believe strongly that the nature of these programs and our overall product pipeline do create a very attractive investment opportunity for new fundraising activities. And I'll be happy to answer any further questions during the Q&A. And now, I'm going to turn the call back over to David.
spk04: Thank you, Mark. Before opening the Q&A session, I'd like to highlight some key changes and progress we've achieved over the past year. It was about a year ago, November the 6th, last year, that we hosted our first quarterly conference call as a recapitalized, newly financed, NASDAQ-listed Geovax. At that time, we discussed our focus on achieving clinical stage status within the priority areas of SARS-CoV-2 and immuno-oncology, while also enhancing our resources and capabilities to rapidly manufacture and distribute products. As the following two slides illustrate, we've remained focused on these priorities, and we now have clinical stage programs within both of the areas of immuno-oncology and SARS-CoV-2. Furthermore, we have additional programs in each of these areas progressing successfully. And we have underway the expansion of MVA manufacturing processes and capabilities intended to support much higher manufacturing capacity within time periods to address epidemics and even pandemics. Now, my colleagues and I will now answer your questions. Unfortunately, Dr. Dimon has had to leave our call, but Dr. Newman is prepared to address any questions you may have related to the O4S1 vaccine program. I'm therefore turning the call over to the operator for instructions on the question and answer period.
spk08: Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Today's first question comes from Jason McCarthy at Maxim Group. Please go ahead.
spk02: Hi, guys. Hope you're well. Thanks for taking the questions. I'd like to start with the O4S1 vaccine, clearly. Is there data out there that shows that the mRNA vaccines are insufficient in bone marrow transplant patients or people of immune compromise? We've seen some publications starting to pop up in solid organ transplant patients that have been boosted like two, three, four, five times, and they get nothing. Is that what the basis of targeting this population is?
spk06: Yes, this is Mark Newman. Let me answer that two ways. Certainly there is data out there that the existing S-only vaccines, the mRNA vaccines, function suboptimally in immune compromised patients. And I think that that would be anticipated, right? Now, one of the main reasons for focusing on this with City of Hope is they are a world-leading institution in dealing with this population, right? It's a transplant and cancer therapy center. So this is the type of patients that they work with. And, you know, Dr. Diamond has actually talked to, you know, during the period of reviewing these data, you know, how motivated he was to make something for that patient population. So, yeah, this is definitely, you know, that's the initial focus. And, you know, the reason that we think it's got some real promise here is is just like we've talked about previously with the Geovax vaccine. So MVA is a good vector. It's self-adjuvanting. It gives its own little booster response, plus the multi-antigen inducing both helper T lymphocytes, toxic T lymphocytes, and antibodies, that more complex and broad response we think will have a better chance of functioning in these immune-compromised patients. And I just will mention, of course, that The patient population we're focused on is one where City of Hope is clearly the world's leader, but immune-compromised patients represent a much larger population group than what this initial study will be focusing on. So we anticipate opportunities to expand studies.
spk02: Great. And when you look towards doing a booster study that phase 1-2, that's planned in healthy subjects. What type of patient do you, or subject rather, do you think you would enroll in terms of age? You know, there's different criteria for how long the, like an mRNA vaccine right now is supposed to last. I don't even know if it's quite clear in the literature. So what would you be looking for specifically in that study? Would you be doing an mRNA comp as a booster versus the O4S1, or how would that work?
spk06: Yeah, so you have to look at the combination of what is doable in the real world, especially in a timely manner and what you would really like to do. What is doable and the approach for this is actually to work with healthcare workers, for example, doctors and nurses at City of Hope, who've all received the Pfizer vaccine as part of the campaign to immunize healthcare workers. And then these people will be literally healthy volunteers and participate in the study. So we're not looking at, we're not anticipating looking at groups that would be in any way limited or immune compromised. These will be people that are relatively healthy, healthy volunteers, but the focus on the recruiting is going to be healthcare workers.
spk02: And would a large component of that data or immunogenicity data be geared towards what the T cell responses are?
spk06: Oh, absolutely. I mean, that's our thing, right? But it's, you know, it's boosting preexisting. So, you know, we understand that the world of COVID vaccines is neutralizing antibodies, which are specific to the S protein. And Dr. Diamond showed you, you know, a snapshot of data that they've generated measuring responses to the receptor binding domain, including, you know, the RBD of multiple variants. So you're looking at boosting that response. What is it when the patient, you know, came in and gave their first sample prior to immunizing? What happens two weeks later? What happens four weeks later? And so on. But obviously T cell responses is where we think is where we're taking the programs. We think this is going to be the difference. It's not designed simply to differentiate us from everybody else. It's done because T cell responses are critically important to control to the induction and to the maintenance of efficacious viral immune responses. So the goal is to broaden the response and the nuclear protein, nuclear capsid protein is one of the more highly dominant, um, targets for T-cell immunity in the natural infection. So it's a perfect fit, an antibody target and a nucleoprotein as the T-cell target.
spk02: Great. And if we could just briefly jump over to the Gideptin program in head and neck. That Phase 1-2 trial is enrolling. Do you have any idea of time-wise of when we could see a data readout from that program?
spk06: I'm going to ask somebody else if they've got a better answer for that. John or David?
spk04: This is David, Jason. Right now, you know, we've just recently assumed that we've just expanded the sites So, we have the five patients thus far in the Stanford, but the others are just starting to go forward. So, at this time, it'd be difficult to discuss, you know, to be able to project a data readout. I would say probably we can address that much more meaningful at the next conference call. But for right now, you know, we're in the process transferring the IND, getting the two new sites fully up and running and basically doing the final selection of the CRO to oversee the entire program.
spk06: And initiating manufacturing, so.
spk04: Exactly, exactly.
spk02: Got it. And then so since it's in second line, head and neck, we've seen some activity in the space. It's got a relatively low bar in terms of response rates, and we've seen some other programs, you know, you take that, what you get in second line, it kind of catapults right up to first line, possibly with checkpoints of different varieties at this point. Is that a long-term goal that Geovax is considering for the Gidepton program?
spk04: Yeah, it's being evaluated. Studies are going on right now to look at just that concept. So, yes. Got it.
spk02: Okay. Thank you, fellas. Thank you.
spk08: And ladies and gentlemen, as a reminder, if you'd like to ask a question, please press stars and one. Our next question comes from Kumar Raja with Brooklyn Capital Markets. Please go ahead.
spk00: Hi, I'm Shubendu calling in for Kumar. Thanks for the update. With respect to the clinical development of the O4S1 vaccine on immunocompromised patients, Do you plan to expand it to other immunocompromised patient groups as well, you know, like HIV or immunodeficiency diseases, or just limited to cancer patients on immunotherapy?
spk06: Yes, so obviously all of that is under discussion and evaluation, kind of like going back and discussing to get depth, and we're now in the process of making, you know, the handoff from City of Hope to the Geovax management, all of those things first. The active phase two is where the focus will be. We don't want to get diluted out, but it'll be data-driven, right? If we're seeing some good results, you can bet we'll be interested in expanding.
spk04: And Kumar, excuse me, Kumar is a colleague, I'll say. This is David Dodd. I'll just say that what you outlined, I mean, the initial program will be focused on this initial group, but certainly the Other immune-compromised cohorts are of high interest to us, but as Mark Newman has pointed out, we'll be guided by what we learn in this first program and what we're seeing in the data, but our anticipation and hope is that we'll be able to move this into additional trials in various immunocompromised populations for the simple reason that that is a is a group represents multiple groups who are not being appropriately served well by the current vaccines that are out there. And so what we're hoping is to fill that void, make it much broader, but targeted for immunocompromised populations. And we've always felt that that was a very strong opportunity, an area that could be filled by MVA type of vaccines.
spk00: Right.
spk04: That's useful.
spk00: Now, with respect to the clinical results of the CMO2 program, the anti-spike immunoglobulin persisted for at least 56 days in hamsters. Have you looked beyond it? And if you could comment on the persistence of the T cell response as well. And also, what kind of longevity of the IgG and T cell responses do you expect in moving into the human trials?
spk06: Well, so to your first question about the animal models, so yeah, the animal model testing is ongoing and we'll be making presentations in scientific, well, one is next week. We have a scientific presentation. We'll be introducing our new data. So we're not only evaluating the pathogenesis in the hamster model, but also protection of single and multiple doses, you know, protection levels in the transgenic ACE2 mouse model. So those data will be released next week for the first time at our next conference. We have a series of scientific presentations coming through between now and the end of the year. And then as far as durability of the responses, I think the data that we have been associated with is from our HIV program. which indicates that the MVA and the VLP process, which is what the CMO2 is based on, induces a very durable response. We think that's the nature of the adjuvant effect that you're getting from the FDA or MVA. So I would expect to see something very similar with the City of Hope. But as Dr. Diamond mentioned, he's showing you data out six months Looks very nice at six months, but he's got a year follow-up plan, and so we'll be continually presenting it. But if you look at, as I said, data that we generated previously in our HIV program and now the data that Dr. Diamond showed, I think there's every indication that the responses are going to be as durable, if not more durable, than what we're seeing with the mRNA.
spk00: Okay, we're good. Finally, I was just wondering if you could provide some color to the ongoing preclinical studies with NIH for the Marburg and Sudan viruses. And for the IND application, do you think that the ongoing tests are going to be enough, or do you expect more studies moving forward?
spk06: So, again, at the end of the year, we're making a summary presentation at the World Vaccine Conference in San Diego, and one of our presentations will be on the hemorrhagic fever vaccines and where we are. So we are testing in non-human primates. Whether these move into a clinical trial is actually more driven probably by market forces. We fully anticipate based on guinea pigs and rodent models that the primate data will suggest or indicate that these are good vaccines in that they will induce responses that you would predict would be, that are protective in a primate. And then in the clinical trial, of course, you don't, these are not efficacy trials, these are just safety and immunogenicity trials. But those are actually driven, and the selection process will be made based on need. So, you know, we have a Marburg outbreak sort of boiling along in a couple places in the world. If that expands, that will drive attention, and then our Marburg vaccines are more likely to float to the top and be pushed up in the queue as far as clinical testing. But as we've always pointed out, these processes are moved along with federal funding, either with the Department of Defense or USAID, BARDA. And so we rely on what they determine is the priority, and it will actually be tested through their network relationships. So I can't tell you that we're going to actually have an IND ready to go at the end of the year if the monkey data looks good. We could, but that will be someone else's decision to push us down that pathway.
spk00: Okay, sounds good. Great. Thanks for taking my questions.
spk08: Ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to David Dodd for closing remarks.
spk04: Okay, thank you. And thank you, everyone, for participating in this conference call, sharing in our milestone achievements resulting in clinical stage status within these two critical areas of immuno-oncology and SARS-CoV-2. But for us, this is just a start as we accelerate our pace of development and progress. We look forward to updating you over the next several weeks and months regarding upcoming milestones for gadeptin, O4S1, CMO2, and other development programs as well as expansion of our capabilities and resources. Finally, I want to acknowledge and thank the GFX Board of Directors, our GFX staff, and the many other parties that continue to support, assist, and advise us towards achieving success. For all of us, it is a great pleasure serving our shareholders and being part of this team. Again, thank you. Have a safe and enjoyable evening.
spk08: Thank you. This concludes today's conference call. We thank you all for attending today's presentation You may now disconnect your lines and have a wonderful evening.
Disclaimer