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spk30: Good afternoon and welcome everyone to the Geovax fourth quarter 2023 corporate update call. My name is Desiree and I will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Dr. Mark Newman, Chief Scientific Officer, Dr. Kelly McKee, Chief Medical Officer, and Dr. John Sharkey, Vice President, Business Development. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gattica of Stern IR.
spk24: Thank you. 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 product candidates with the desired characteristics in a timely manner, and such products will be safe for human use. Geovax's vaccines will effectively prevent targeted infections in humans Geovax's product candidates will receive regulatory approvals necessary to be licensed and marketed. Geovax raises required capital to complete development of its products. There is development of competitive products that may be more effective or easier to use than Geovax's products. 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 is now my pleasure to introduce the Chairman and CEO of Geovax, David Dodd.
spk21: Good afternoon, and thank you.
spk14: for participating in the Giavax corporate update call. Last year, and more specifically during the fourth quarter, we successfully advanced our developments, focused on the two Phase II clinical stage products while also advancing other critically important initiatives. Today, we'll discuss the progress, status, and plans related to Gideptin, currently in development as a therapy against advanced head and neck cancer, and GEOCM04S1, our next generation COVID-19 vaccine. Our goal is to develop innovative cancer therapies and infectious disease vaccines, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate worldwide development, commercialization, distribution via business partnerships and collaborations. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then your questions will be addressed. At year-end, we announced the closure of enrollment for the Phase 1-2 trial of Gideptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care, the 15,000 in the U.S. and 400,000 worldwide. These patients represent a critical unmet medical need. Many are unable to swallow food and have difficulty speaking. Typically, they have exhausted existing therapies and standard of care and are receiving palliative care. Our goal has been to provide an improved end-stage quality of life in these patients by shrinking and or eliminating various targeted tumors and to provide clinical evidence supporting advancement of this therapy in earlier stage disease. As you may recall, this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program. Last July, initial clinical data results were presented at the AACR AHNS conference in Montreal. That presentation noted that administration of gadeptin was shown to be safe and feasible, reflecting stabilization and or reduction in size of treated tumors. We expect to report the final results of this trial during first half 2024, followed by discussing our plans for further evaluation of gadeptin in patients with advanced head and neck cancer. Our strategy also considers gadeptin therapy for earlier stage HNSTC with less tumor burden, including a role similar to neoadjuvant or cytoreductive radiotherapy in combination with checkpoint blockade inhibition. We also anticipate discussions with the FDA during 2024 related to an expedited path to registration. The vast array of unmet medical needs within oncology represents significant opportunities for Geovax to advance novel approaches addressing various cancer patient needs worldwide. We refer to Godeptin as tumor agnostic, meaning that its mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology, and we're participating in various oncology and partnering conferences. and some of which we will present conducting clinical data and with others to conduct partnering discussions. GEOCMO4S1, our next-generation COVID-19 vaccine, aims to provide a more practical, public-health-friendly COVID-19 vaccine solution than that offered with currently approved vaccines by stimulating a robust and durable immune response across multiple virus variants as a result of targeting both the antibody and cellular arms of the immune system. and through the use of a proven safe and efficient replication-deficient vaccine delivery catalog. This is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccines and monoclonal antibody therapies are inadequate. The immune profile generated following receipt of CMO4S1 also positions it well for more general use as a heterologous booster for to current mRNA vaccines, providing a more robust, durable, functional response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccines. Three Phase II clinical trials are underway with CMO4S1, two of which address the high-risk populations of immunocompromised patients. The other Phase II trial is evaluating our vaccine as a booster following prior receipt of an mRNA vaccine. We hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the millions of immunocompromised patients while also demonstrating the vaccine as a more robust, durable, universal booster for the current authorized vaccines. Last September, we completed enrollment in our Phase II trial assessing CMO4S1 as a booster for the mRNA vaccines. This trial involves 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine. The immunological responses measured throughout the study include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Earlier this month, we reported positive interim data from this trial, indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and the highly virulent Omicron XBB1.5, as well as demonstrating robust cellular immune responses. Additional testing against the current variant of concern, the JN1 variant, is currently underway. Final results from this trial are anticipated during the fourth quarter of this year, reflecting the 12-month monitoring of these patients. Previously, we've discussed in the U.S. there are approximately 15 million immunocompromised individuals. Worldwide, there are an estimated over 240 million. Such populations include those with various blood cancers, renal disease, autoimmune diseases such as lupus. They include transplant patients and others with disease or therapy-induced immunosuppression. Many of these patients are limited in their ability to respond adequately to the approved mRNA vaccines, placing them at significantly increased risk of severe COVID-9 infection, hospitalization, and potential death. Recently, it was reported in JAMA on February the 15th that the number of immunocompromised adults in the U.S. has been updated, indicating a population of 23 million versus the previous estimate of 15 million. There is a major critical need for next-generation COVID-19 vaccines to support such individuals, And we believe that CMO4S1 is the leading next-generation vaccine in clinical development in support of the needs of immunocompromised patients. During 2023, initial data from stem cell transplant trial was presented at several international conferences, including the World Vaccine Congress in Washington, D.C. In addition, results were published this past September in the peer-reviewed journal Vaccines. These findings demonstrated robust immunogenicity illustrating the vaccine's ability to strongly induce both antibody and T-cell responses essential for conferring protection, particularly in immunocompromised individuals. The vaccine's article also highlighted the unique feature of CMO4S1 providing protective immune levels from the ancestral Wuhan strain all the way through what I mentioned earlier, the highly virulent Omicron XBB1.5 variant. Initial patient enrollments into this trial occurred at the City of Hope Medical Center in California. More recently, however, additional sites have been added as we seek to accelerate the pace of trial enrollment. In addition to the patients initially enrolled from City of Hope, there are now four additional sites actively recruiting patients into this critically important Phase 2 trial. The four expansion sites include the Fred Hutchinson Cancer Center in Seattle, University of Massachusetts Medical Center in Worcester, Mass., Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, and Eastern Carolina Medical Center in Benson, North Carolina. While we are currently focused on optimizing patient enrollment from these sites, we've seen considerable interest, both domestically and internationally, in participating in this clinical study. Following the initiation of patient enrollment in the immunocompromised CLL trial last August, This investigator-initiated trial has continued to recruit and enroll patients, more recently expanding to additional City of Hope locations. The trial is designed to evaluate CMO4 S1 among approximately 80 CLL patients, directly comparing with the Pfizer-BioNTech mRNA vaccine. Typically, these patients are unable to generate adequate levels of protective antibodies following mRNA vaccinations. due to their underlying hematologic malignancy placing them at extreme risk of developing clinically severe COVID-19. As a consequence, many of these patients remain homebound more than three years since the pandemic began. We are optimistic that CMO4S1 can offer these individuals the protection from these virus that they so desperately need. Results from an interim analysis of the ongoing trial are anticipated during the first half of 2024. Relative developing CMO4S1 among immunocompromised patients, we believe that an opportunity exists for an expedited regulatory path due to our focus on such high-risk, unserved populations. Now I'd like to comment regarding Project NextGen. Last April, the White House announced this $5 billion initiative to follow from Operation Warp Speed, seeking COVID-19 vaccines with enhanced breadth of protection against variants, and improved durability, particularly interested in novel vaccine candidates already in clinical trials. We believe that CMO4S1 is a prime example of the desired next-generation COVID-19 vaccine. Regarding Project NextGen, we continue with active discussions related to formal participation in this program. Of the $5 billion set aside for funding, there remains over $3 billion still to be awarded. Beyond noting that we remain in active discussions and negotiations regarding participation, we can't comment further at this time. Finally, related to CMO4S1, we anticipate partnering and collaborations in additional clinical and research efforts and in support of worldwide commercialization and distribution. Active initiatives are underway in this area. Overall, we're addressing opportunities that provide us a basis for achieving leadership within those targeted patient areas and commercial markets. Our current clinical stage products, Gedefin and CMO4S1, are focused on patient populations currently unserved by existing vaccines and or therapies. We believe that the potential of achieving product leadership in addressing the therapeutic and vaccine needs of these respective populations exists, and we're focused in that area. Also, GEO-MVA, our vaccine against mpox and smallpox, is intended to disrupt an existing global monopoly in that important area, providing us a leadership position as the first U.S.-based supplier of such a vaccine. We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. During this year, we'll report further progress and results from our CMO4S1 Phase II programs, and for Godeptin, we expect to report the final results from the current trial and our plans for the expanded Phase II trial. We also expect to report further plans regarding next steps related to evaluating Godeptin as combination therapy used in conjunction with immune checkpoint inhibitors. Relative to our MVA vaccine against MPOX and smallpox, we anticipate reporting our regulatory path and plans related to advancing that product towards registration. Finally, we anticipate further updates related to our advanced MVA manufacturing process targeted to enable Geovac to effectively produce and distribute MVA-based vaccines in response to real-time market needs worldwide. To summarize, our various clinical stage products, Gadefin, CMO4S1, and MVA represent clinically important areas of medical needs, largely unserved by current products and standard of care. We are pleased with the consistent encouraging results we're seeing from our clinical trials. Moreover, we believe that expedited paths to registration are feasible for these products. From a potential commercial perspective, These product opportunities represent an estimated annual U.S. revenue potential of almost $30 billion. Now, that's not a sales forecast, but rather a reflection of the significance of the need to address these critically important areas. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence that we have relative to the outlook for GF access shareholders and stakeholders. Now I'd like to turn the presentation over to Mark Reynolds, GFAC's Chief Financial Officer, for a review of our recent results and financial status. Mark? Thank you, David. I'll start the financial review with our income statement. We had no active grants during 2023, so we reported no grant revenues this year as compared to a small amount in 2022. However, as David has noted, we are having ongoing discussions with BARDA relative to Project NextGen. If an award is Were to be made, this would become a very important component of our financing mix going forward, as well as a catalyst for other financing efforts. But there is no award to date, so these are definitely forward-looking statements. Research and development expenses were $20.7 million in 2023 versus $9.1 million in 2022, an increase of $11.6 million. This increase is primarily associated with accelerated clinical trial activity,
spk17: for our CMO4S1 and gadeptin programs, including manufacturing costs for clinical trial materials.
spk14: The increase also includes costs associated with the AGE1 cell line manufacturing technology licensed from Probiogen, which will be important to the future commercialization and partnering activities for all of our MVA-based vaccines. General administrative expenses were $6 million in 2023 versus $5 million in 2022, with the increase mostly associated with higher legal and patent costs, investor relations expenses, consulting fees, and personnel costs. Interest income was $776,000 in 23 versus just $7,000 in 22, reflecting increasing interest rates available through our money market accounts. So overall net loss for 23 was $26.5 million, or $14.29 per share, versus $14 million in 2022, or $12.36 per share, again with the increase being driven by the clinical trial burdens. Now to the balance sheet, our cash balances at December 31st of 23 were approximately $6.5 million as compared to $27.6 million at the end of 2022. The change in our cash balances is reflective of $25 million used in operating activities, partially offset by $4.1 million in net proceeds from the exercise of warrants in this past December.
spk17: Outstanding common shares currently stand at $2.2 million following the reverse split we executed in January this year, which brought us back into full NASDAQ compliance. Funding our ongoing Phase II clinical programs for CMO4S1 and GADEPTIN will continue to be the most significant use of our cash for 2024.
spk14: We don't expect this prioritization of our spending to change if we receive a Project Next Gen award from BARDA as any incremental spending for that program will be funded by the award.
spk17: We do expect to raise additional capital to fund programs in 2024, and we intend to do that in conjunction with Positive News Flow. I'll be happy to answer questions during the Q&A, and I'll turn the call back to David now.
spk14: Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Drs. Mark Newman, Kelly McKee, and John Sharkey. our Chief Scientific Officer, Chief Medical Officer, and Vice President of Business Development, respectively.
spk21: I'll now turn the call over to the operator for instructions on the question and answer period.
spk19: We will now begin the question and answer session.
spk30: To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2.
spk19: At this time, we will pause momentarily to assemble our roster.
spk30: The first question comes from the line of James Molloy with Alliance Global Partners. Your line is open.
spk29: Hello, this is Laura Suriel on for Jim Malloy. Thank you for taking the questions. So with the positive interim results that you already gathered for the phase two trial of your COVID booster vaccine in Healthy Volunteers, do you anticipate similar efficacy against the newer JN1 COVID variant? And what other findings might you be expecting from this trial once full top line results are gathered?
spk14: Sure. Thank you. This is David Dodd. Thank you for your question. And I'll make some comments, and then I'll ask Kelly McKay, our chief medical officer, if he'd like to add in. But we're very pleased with the initial results that we've seen. The trial is fully enrolled. It will be tracking these patients through September of this year, and then we'll see the final results. Right now, we have no reason to believe that our vaccine would not continue to address the variants, including JN1. as it has all the others. But until our testing is completed, we have no data to support that statement. But we are very pleased that whereas the mRNA vaccines have had to be reconfigured as new variants of concern have emerged, such as the Delta, the various Omicron, the XBB, 1.5, et cetera, remember the bivalence, et cetera, that our vaccine without any reconfiguration has continued to to demonstrate strong protective immunity. We believe that's because of the dual approach of targeting both the antibody as well as the cellular immunity. But I'll ask Kelly if he'd like to add anything to that.
spk31: Thanks, David. I think you pretty much covered the waterfront on that one. Yeah, we don't have any reason to expect that neutralization of JN1 will be significantly different from anything that we've seen with the other Omicron variants we've tested. But, you know, the proof is going to be in the testing, and we'll have to wait until those test results come back.
spk29: Got it. And then also for your gadeptin candidate, What additional indications might you consider for a combination therapy alongside immune checkpoint inhibitors? And do you currently have any clinical development plans for this program?
spk31: Kelly, would you like to address that? Sure. So as was sort of noted earlier, you know, this technology should be tumor agnostic. The mechanism of action is such that any solid tumor should be responsive to the treatment. And so we are right now sort of exploring what other tumor types would be most amenable to this approach sort of as a next step beyond head and neck cancer. The head and neck cancer was initially chosen for a number of reasons, not the least of which was the accessibility of head and neck tumors to needle injections, which is sort of the requisite first step in these treatment regimens. And so, you know, as we sort of look at other tumor types that might be amenable to a needle injection approach, some of the advanced breast tumors sort of come up as prime candidates. And we're in active discussions with a group at Emory about a trial looking at GADEP in certain breast tumor, advanced breast tumor, metastatic breast tumor types. The design of that is still sort of under discussion and any timing for us The start of such a trial is out in the future at some point, but we are talking to people about that.
spk19: Got it. Thank you for taking the questions.
spk21: Thank you.
spk30: Our next question comes from the line of Jeffrey Cross with Crystal Research. Your line is open.
spk15: Thank you very much. The Bartha agreement for other companies has been extremely valuable in terms of market cap appreciation. When we looked at some of those other companies, the additions to the market capitalization period about just the increase in the stock price has been very powerful for them. How are the discussions going on that front, and do things continue to proceed in the direction that you would like them to be?
spk14: Thus far, we're very pleased with the discussions. We'd love to have received an award letter yesterday or even today that hasn't occurred, but they are very positive, they're encouraging, and we try not to try to model or give out, and certainly we don't think the impact of receiving an award, it'll be very positive, it certainly won't be negative, but we're not speculating what the what the range of that might be. But like everyone else, we're aware of the value of participating and being selected to award in that program. And I'll just say that we have had continued, ongoing, involved discussions that, by and large, are most encouraging.
spk15: Okay, thank you very much. With regard to GADEPTIN, we have not seen any other trials significantly advance in that area ahead of providing results that we've seen from your product. Is there any new technology that you see on the horizon that you felt has additional threats, or do you still feel as confident with your technology as you have been given the results you've been able to achieve so far?
spk14: I would say, and then I'll ask if either Kelly or Mark Newman wish to add in, but I'm not aware of any other. There's a lot of work that's going on for head and neck cancer because that's an important There's over 70,000 new cases every year now, and we're seeing now 16,000 deaths. That latter is what we're addressing, at least as our initial indication. I would say the advanced technology may well be the combination therapy of the gadeptin technology in conjunction with the immune checkpoint inhibitors. That may be what would be the next stage advanced technology. Our goal right now is to complete the evaluation of what we hope to be able to announce until yet this half, and then to lay out our plans for going forward and keep everybody updated. But we're not aware of any other technology that's directly coming after what we're focused on right now. We see a lot of good ideas and approaches for earlier stage solid tumors. And in the end, they may very well be highly complimentary, the maybe synergy of those technologies with Gidepton.
spk21: Okay, if no others, I can go to the next question.
spk30: Next question comes from the line of Robert Lemoyer with Nobel Capital Markets. Your line is open.
spk09: I had a question on Gudeptin and the clinical trials. I was hoping you could just clarify a little bit of the plans you had mentioned, expansion of the phase two, a neoadjuvant, and combinations with checkpoint inhibitors. Are these going to be separate trials that begin in sequence or arms of one trial or just any any clarification on how you're looking at all of these potential combinations of gadeptin? Sure.
spk31: I'll ask Kelly to pick up on this one. Yeah. You're sort of focusing on exactly the dilemma that we face and It's a topic that's under active discussion as we speak. We're very encouraged by what we've seen with our Phase I and Phase I-II trials up to this point, particularly in terms of the sort of mechanism of action and translating that into a response that we anticipated seeing in these patients. And so the question then becomes where do we go from here? We put together an advisory committee consisting of a number of head and neck cancer oncologists and head and neck cancer surgeons with whom we're scheduled to meet towards the end of April to discuss exactly the the question that you asked I mean what what's what's the most logical next step you know this is a very although there's as David indicated there's not there's not a lot of competition with regard to our specific technology you
spk14: I think Kelly's having some phone difficulties, but I think we were saying that, you know, specifically with our technology, we don't see a lot of competition, but there is a lot going on that's addressing solid tumors, and I'd say they're very novel, all good ideas.
spk31: Eric, with checkpoint inhibitors, should this be an add-on? Should this be a, you know, a monotherapy to which we then overlay a checkpoint inhibitor? Should we progress into earlier stage disease? All of these questions, I think they're sort of interrelated and we're going to be heavily reliant on the advice of our advisory committee to sort of guide us into where we go next. But the short answer to your question is we don't really know at this point in time.
spk09: Okay, yeah, that's totally fair and relying on the head and neck surgeons who advise you, you know, is a good, a good course of action. So I won't ask you to speculate and I'll just wait for the update after you have that meeting with them. Uh, the, uh, you know, they all make sense to me, but it's their opinion that counts more. So, uh, Just in terms of the MPOCs and the NVA manufacturing process, since that's not something where you have a clinical trial or a presentation at a conference, are there any milestones or announcements that we should be looking for that would signal progress in the manufacturing process or the market in that program?
spk21: Let me ask, John Sharkey, would you pick up on that, please?
spk20: Sure. Hey, Robert, nice talking with you again.
spk21: Yeah.
spk04: Remember, MBA in our manufacturing environment is like a lot of our other vaccines. So as we move forward to implement our MBA production for our different vaccine candidates, such as O4S1 and others at ABL, that platform will be useful also for MBA. Regarding specific MBA milestones, we remain highly confident and optimistic that there is an expedited pathway forward to bring a MBA vaccine for monkeypox and smallpox to the marketplace. We are advancing our discussions with regulators to map that out. and I would expect that we would be updating the market once we have agreement on the plan towards registration. As always, you never get yes, do this, and you'll get it, but you get agreement on how to move something forward. I would expect we would be bringing that forward and sharing with the market this year.
spk21: Earlier would probably have been later. Okay, great. Thank you very much for that.
spk19: Next question comes from the line of Jason Colbert with Dawson James.
spk30: Your line is open.
spk08: Hi, guys. Good seeing you recently. I'd like to ask you a little bit about financing. We're in a very tough environment for micro-caps. They've been under a lot of pressure. How do you anticipate raising capital over the coming year?
spk14: Mark Reynolds, I'll toss that easy answer question to him.
spk17: The simple answer, Jason, is we'll raise funds opportunistically.
spk14: You know, every biotech CEO will tell you we'll raise as much money when and wherever we can.
spk17: You know, we have said in our public filings that we've got cash runway through into Q2 of this year. So you could expect to see some fundraising activity within that time frame.
spk08: And can you narrow in with me on that time frame, what you think might be catalysts that could help drive the stock?
spk14: It's going to be some continued data flow from the trials. It's going to be the most significant item, which is the elephant in the room, is the Project NextGen award from BARDA. You know, we can't count on that because, you know, that's definitely a forward-looking statement to say that we even are contemplating that award.
spk17: But we're very confident in that regard. So I think that would be a significant catalyst for us to look at fundraising upon.
spk08: And remind me how big that award could be and whether that award goes beyond just like a time and materials or is it supply? Just can you go into that a little bit? David, do you want to take that question?
spk18: No, you can go ahead with it.
spk14: The type of award that we expect may come would be, I'll call it a modest amount directly to the company. But the value of the award would be immensely more than what we would receive directly. You call it the bio-bucks.
spk17: The benefit to the company could be in the hundreds of millions of dollars. But again, that's a forward-looking statement. We'll have to defer to see when an award comes, how it's structured. Okay.
spk08: Thank you very much. It looks like a pretty important catalyst.
spk14: Yes, it is, Jason. Let me just add on. The way that these awards have been coming is that there's a direct award to the company. and that's for the planning of Phase II. And then it may, then there'll be a direct payment to the CRO that's going to be supporting the clinical program, and that can be $300-plus million in value. So when you see these awards announced, you'll see some of them will announce that they've received this initial award of $10 million directly, but the value that they're receiving is 350 million. So that's how it's been reflected in various press releases. Yeah, that's really helpful.
spk21: Thank you, David. You're welcome.
spk30: Our next question comes from the line of Vernon Bernardino with HC Wainwright. Your line is open.
spk05: Hi, David and team. Thanks for taking my question. You probably saw that ACIP recommended persons over 65 years of age should receive an additional dose of COVID vaccine. Does the recommendation or any of the language from the meeting change your thinking as far as strategy, market opportunity, or priorities?
spk14: Not at all. If anything, it underscores where we differentiate. because what has been going on, as we've all noticed, and we're seeing, you know, reports from the CDC and others that the famous efficacy of 95%, et cetera, seems to be more like about 50%, depending how you measure efficacy. And we're seeing that durability, which is why we're having to see so many boosters continuously being added, is that the durability of the existing vaccines appears to be somewhere between two to four or two to six months. I mean, it just is not the durability versus what was originally communicated, which was that they would be good for a year. And yet we're seeing right now with the data that we're getting out of our trials, durability in excess of eight months. So we right now are seeing data that demonstrate that our durability is about a 2X of what is being noted in the clinical data the clinical use of the current vaccines. There is increasingly more and more publications and statements in addressing the needs of the elderly, depending on how you define the elderly, but also those with the compromised immune systems. It's well accepted that that latter group of people have depleted immune systems because of various medical conditions, that they are at the highest risk of severe disease, hospitalization, and and the risk of death. And this is again where we see with our construct of coming in and having a strong focus on not only on the antibody side, but also on the cellular side, giving what we're seeing right now gives us a broader, almost very agnostic immune response, but also greater durability. We think that as our product is progressing through its clinical trials, there's increasingly more and more evidence of why Project NextGen is such a critical program that the White House announced last year, because it's the recognition that what is out there is inadequate in many different ways.
spk05: Now, as a follow-up, I didn't attend or view the proceedings. I didn't see any mention as far as immunocompromised individuals. Did you gain any insight from the ACA? ACIP meeting about immunocompromised individuals and booster shots?
spk14: Not in the recent meeting, but it's been so well underscored by the CDC, by the WHO, and others that the highest risk groups are those with compromised immune systems.
spk05: Okay, yes. I'm definitely excited for that clinical trial as well. Thanks for taking my question and my follow-up.
spk21: Looking forward to the progress this year. Thank you so much.
spk19: Again, if you have a question, please press star, then one. There are no further questions at this time.
spk30: This concludes our question and answer session. I would like to turn the conference back over to David Dodd for any closing remarks.
spk14: Thank you, and thank you, everyone. We really appreciate your participation in this corporate update call and in joining us and sharing the achievements, progress, and our outlook. And indeed, your interest is greatly appreciated. I want to especially acknowledge and thank our board of directors and advisors, our GEOVAC staff, and the many other parties that continue to support and advise us towards achieving success. In achieving our success, we're committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapies, infectious disease vaccines, and redefining how success is defined in addressing various patient populations. For all of us, it's been a great pleasure serving our shareholders, our stakeholders, and being part of this team. I wish everyone a safe evening and a wonderful rest of the week. Thank you.
spk30: Now concluded. you for attending today's presentation. You may now disconnect. Hello. Bye. Thank you. Good afternoon and welcome everyone to the Geovax fourth quarter 2023 corporate update call. My name is Desiree and I will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Dr. Mark Newman, Chief Scientific Officer, Dr. Kelly McKee, Chief Medical Officer, and Dr. John Sharkey, Vice President, Business Development. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gattica of Stern IR.
spk24: Thank you. 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 product candidates with the desired characteristics in a timely manner, and such products will be safe for human use. Geovax's vaccines will effectively prevent targeted infections in humans Geovax's product candidates will receive regulatory approvals necessary to be licensed and marketed. Geovax raises required capital to complete development of its products. There is development of competitive products that may be more effective or easier to use than Geovax's products. 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 is now my pleasure to introduce the Chairman and CEO of Geovax, David Dodd.
spk21: Good afternoon, and thank you.
spk14: for participating in the Giavax corporate update call. Last year, and more specifically during the fourth quarter, we successfully advanced our developments, focused on the two phase two clinical stage products while also advancing other critically important initiatives. Today, we'll discuss the progress, status, and plans related to Gideptin, currently in development as a therapy against advanced head and neck cancer, and GEOCM04S1, our next generation COVID-19 vaccine. Our goal is to develop innovative cancer therapies and infectious disease vaccines, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate worldwide development, commercialization, distribution via business partnerships and collaborations. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then your questions will be addressed. At year-end, we announced the closure of enrollment for the Phase 1-2 trial of Gideptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care, the 15,000 in the U.S. and 400,000 worldwide. These patients represent a critical unmet medical need. Many are unable to swallow food and have difficulty speaking. Typically, they have exhausted existing therapies and standard of care and are receiving palliative care. Our goal has been to provide an improved end-stage quality of life in these patients by shrinking and or eliminating various targeted tumors and to provide clinical evidence supporting advancement of this therapy in earlier stage disease. As you may recall, this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program. Last July, initial clinical data results were presented at the AACR AHNS conference in Montreal. That presentation noted that administration of gadeptin was shown to be safe and feasible, reflecting stabilization and or reduction in size of treated tumors. We expect to report the final results of this trial during first half 2024, followed by discussing our plans for further evaluation of gadeptin in patients with advanced head and neck cancer. Our strategy also considers gadeptin therapy for earlier stage HNSTC with less tumor burden, including a role similar to neoadjuvant or cytoreductive radiotherapy in combination with checkpoint blockade inhibition. We also anticipate discussions with the FDA during 2024 related to an expedited path to registration. The vast array of unmet medical needs within oncology represents significant opportunities for Geovax to advance novel approaches addressing various cancer patient needs worldwide. We refer to Godeptin as tumor agnostic, meaning that its mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology, and we're participating in various oncology and partnering conferences. and some of which we will present conducting clinical data and with others to conduct partnering discussions. GEOCMO4S1, our next-generation COVID-19 vaccine, aims to provide a more practical, public-health-friendly COVID-19 vaccine solution than that offered with currently approved vaccines by stimulating a robust and durable immune response across multiple virus variants as a result of targeting both the antibody and cellular arms of the immune system, and through the use of a proven safe and efficient replication-deficient vaccine delivery catalog. This is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccines and monoclonal antibody therapies are inadequate. The immune profile generated following receipt of CMO4S1 also positions it well for more general use as a heterologous booster to current mRNA vaccines, providing a more robust, durable, functional response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccines. Three Phase II clinical trials are underway with CMO4S1, two of which address the high-risk populations of immunocompromised patients. The other Phase II trial is evaluating our vaccine as a booster following prior receipt of an mRNA vaccine. We hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the millions of immunocompromised patients while also demonstrating the vaccine as a more robust, durable, universal booster for the current authorized vaccines. Last September, we completed enrollment in our Phase II trial assessing CMO4S1 as a booster for the This trial involves 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine. The immunological responses measured throughout the study include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Earlier this month, we reported positive interim data from this trial, indicating no serious adverse events, and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and the highly virulent Omicron XBB1.5, as well as demonstrating robust cellular immune responses. Additional testing against the current variant of concern, the JN1 variant, is currently underway. Final results from this trial are anticipated during the fourth quarter of this year, reflecting the 12-month monitoring of these patients. Previously, we've discussed in the U.S. there are approximately 15 million immunocompromised individuals. Worldwide, there are an estimated over 240 million. Such populations include those with various blood cancers, renal disease, autoimmune diseases such as lupus. They include transplant patients and others with disease or therapy-induced immunosuppression. Many of these patients are limited in their ability to respond adequately to the approved mRNA vaccines, placing them at significantly increased risk of severe COVID-9 infection, hospitalization, and potential death. Recently, it was reported in JAMA on February the 15th that the number of immunocompromised adults in the U.S. has been updated, indicating a population of 23 million versus the previous estimate of 15 million. There is a major critical need for next-generation COVID-19 vaccines to support such individuals And we believe that CMO4S1 is the leading next-generation vaccine in clinical development in support of the needs of immunocompromised patients. During 2023, initial data from stem cell transplant trial was presented at several international conferences, including the World Vaccine Congress in Washington, D.C. In addition, results were published this past September in the peer-reviewed journal Vaccines. These findings demonstrated robust immunogenicity illustrating the vaccine's ability to strongly induce both antibody and T-cell responses, essential for conferring protection, particularly in immunocompromised individuals. The vaccine's article also highlighted the unique feature of CMO4S1, providing protective immune levels from the ancestral Wuhan strain all the way through what I mentioned earlier, the highly virulent Omicron XBB1.5 variant. Initial patient enrollments into this trial occurred at the City of Hope Medical Center in California. More recently, however, additional sites have been added as we seek to accelerate the pace of trial enrollment. In addition to the patients initially enrolled from City of Hope, there are now four additional sites actively recruiting patients into this critically important phase two trial. The four expansion sites include the Fred Hutchinson Cancer Center in Seattle, University of Massachusetts Medical Center in Worcester, Mass., Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, and Eastern Carolina Medical Center in Benson, North Carolina. While we are currently focused on optimizing patient enrollment from these sites, we've seen considerable interest, both domestically and internationally, in participating in this clinical study. Following the initiation of patient enrollment in the immunocompromised CLL trial last August, this investigator-initiated trial has continued to recruit and enroll patients, more recently expanding to additional City of Hope locations. The trial is designed to evaluate CMO4S1 among approximately 80 CLL patients, directly comparing with the Pfizer-BioNTech mRNA vaccine. Typically, these patients are unable to generate adequate levels of protective antibodies following mRNA vaccinations. due to their underlying hematologic malignancy placing them at extreme risk of developing clinically severe COVID-19. As a consequence, many of these patients remain homebound more than three years since the pandemic began. We are optimistic that CMO4S1 can offer these individuals the protection from these virus that they so desperately need. Results from interim analysis of the ongoing trial are anticipated during the first half of 2024. Relative developing CMO4S1 among immunocompromised patients, we believe that an opportunity exists for an expedited regulatory path due to our focus on such high-risk, unserved populations. Now I'd like to comment regarding Project NextGen. Last April, the White House announced this $5 billion initiative to follow from Operation Warp Speed, seeking COVID-19 vaccines with enhanced breadth of protection against variants, and improved durability, particularly interested in novel vaccine candidates already in clinical trials. We believe that CMO4S1 is a prime example of the desired next-generation COVID-19 vaccine. Regarding Project NextGen, we continue with active discussions related to formal participation in this program. Of the $5 billion set aside for funding, there remains over $3 billion still to be awarded. Beyond noting that we remain in active discussions and negotiations regarding participation, we can't comment further at this time. Finally, related to CMO4S1, we anticipate partnering and collaborations in additional clinical and research efforts and in support of worldwide commercialization and distribution. Active initiatives are underway in this area. Overall, we're addressing opportunities that provide us a basis for achieving leadership within those targeted patient areas and commercial markets. Our current clinical stage products, Gedefin and CMO4S1, are focused on patient populations currently unserved by existing vaccines and or therapies. We believe that the potential of achieving product leadership in addressing the therapeutic and vaccine needs of these respective populations exists, and we're focused in that area. Also, GEO-MVA, our vaccine against MFOX and smallpox, is intended to disrupt an existing global monopoly in that important area, providing us a leadership position as the first U.S.-based supplier of such a vaccine. We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. During this year, we'll report further progress and results from our CMO4S1 Phase II programs, and for Godeptin, we expect to report the final results from the current trial and our plans for the expanded Phase II trial. We also expect to report further plans regarding next steps related to evaluating Godeptin as combination therapy used in conjunction with immune checkpoint inhibitors. Relative to our MVA vaccine against MPOX and smallpox, we anticipate reporting our regulatory path and plans related to advancing that product towards registration. Finally, we anticipate further updates related to our advanced MVA manufacturing process targeted to enable GEOVAC to effectively produce and distribute MVA-based vaccines in response to real-time market needs worldwide. To summarize, our various clinical stage products, Gadefin, CMO4S1, and MVA, represent clinically important areas of medical needs, largely unserved by current products and standard of care. We are pleased with the consistent encouraging results we're seeing from our clinical trials. Moreover, we believe that expedited paths to registration are feasible for these products. From a potential commercial perspective, These product opportunities represent an estimated annual U.S. revenue potential of almost $30 billion. Now, that's not a sales forecast, but rather a reflection of the significance of the need to address these critically important areas. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence that we have relative to the outlook for GFX, our shareholders and stakeholders. Now I'd like to turn the presentation over to Mark Reynolds, GVAC's Chief Financial Officer, for a review of our recent results and financial status. Mark? Thank you, David. I'll start the financial review with our income statement. We had no active grants during 2023, so we reported no grant revenues this year as compared to a small amount in 2022. However, as David has noted, we are having ongoing discussions with BARDA relative to Project NextGen. If an award Were to be made, this would become a very important component of our financing mix going forward, as well as a catalyst for other financing efforts. But there is no award to date, so these are definitely forward-looking statements. Research and development expenses were $20.7 million in 2023 versus $9.1 million in 2022, an increase of $11.6 million. This increase is primarily associated with accelerated clinical trial activity, for our CMO4S1 and gadeptin programs, including manufacturing costs for clinical trial materials. The increase also includes costs associated with the AGE1 cell line manufacturing technology licensed from Probiogen, which will be important to the future commercialization and partnering activities for all of our MVA-based vaccines. General administrative expenses were $6 million in 2023 versus $5 million in 2022, with the increase mostly associated with higher legal and patent costs, investor relations expenses, consulting fees, and personnel costs. Interest income was $776,000 in 2023 versus just $7,000 in 2022, reflecting increasing interest rates available through our money market accounts. So overall net loss for 23 was $26 million, or $14.29 per share, versus $14 million in 2022, or $12.36 per share, again with the increase being driven by the clinical trial programs. Now to the balance sheet, our cash balances at December 31st of 23 were approximately $6.5 million as compared to $27.6 million at the end of 2022. The change in our cash balances is reflective of $25 million used in operating activities, partially offset by $4.1 million in net proceeds from the exercise of warrants in this past December.
spk17: Outstanding common shares currently stand at $2.2 million following the reverse split we executed in January this year, which brought us back into full NASDAQ compliance.
spk14: Funding our ongoing Phase II clinical programs for CMO4S1 and GADEPTIN will continue to be the most significant use of our cash for 2024. We don't expect this prioritization of our spending to change if we receive a Project NextGen award from BARDA as any incremental spending for that program will be funded by the award.
spk17: We do expect to raise additional capital to fund programs in 2024, and we intend to do that in conjunction with Positive News Flow. I'll be happy to answer questions during the Q&A, and I'll turn the call back to David now.
spk14: Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Drs. Mark Newman, Kelly McKee, and John Sharkey. our Chief Scientific Officer, Chief Medical Officer, and Vice President of Business Development, respectively.
spk21: I'll now turn the call over to the operator for instructions on the question and answer period.
spk19: We will now begin the question and answer session.
spk30: To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2.
spk19: At this time, we will pause momentarily to assemble our roster.
spk30: The first question comes from the line of James Molloy with Alliance Global Partners. Your line is open.
spk29: Hello, this is Laura Suriel on for Jim Malloy. Thank you for taking the questions. So with the positive interim results that you already gathered for the phase two trial of your COVID booster vaccine in Healthy Volunteers, do you anticipate similar efficacy against the newer JN1 COVID variant? And what other findings might you be expecting from this trial once full top line results are gathered?
spk14: Sure. Thank you. This is David Dodd. Thank you for your question. And I'll make some comments, and then I'll ask Kelly McKay, our chief medical officer, if he'd like to add in. But we're very pleased with the initial results that we've seen. The trial is fully enrolled. It will be tracking these patients through September of this year, and then we'll see the final results. Right now, we have no reason to believe that our vaccine would not continue to address the variants, including JN1. as it has all the others. But until our testing is completed, we have no data to support that statement. But we are very pleased that whereas the mRNA vaccines have had to be reconfigured as new variants of concern have emerged, such as the Delta, the various Omicron, the XBB, 1.5, et cetera, remember the bivalence, et cetera, that our vaccine without any reconfiguration has continued to to demonstrate strong protective immunity. We believe that's because of the dual approach of targeting both the antibody as well as the cellular immunity. But I'll ask Kelly if he'd like to add anything to that.
spk31: Thanks, David. I think you pretty much covered the waterfront on that one. Yeah, we don't have any reason to expect that neutralization of JN1 will be significantly different from anything that we've seen with the other Omicron variants we've tested. But, you know, the proof is going to be in the testing, and we'll have to wait until those test results come back.
spk29: Got it. And then also for your gadeptin candidate, What additional indications might you consider for a combination therapy alongside immune checkpoint inhibitors? And do you currently have any clinical development plans for this program?
spk31: Kelly, would you like to address that? Sure. So as was sort of noted earlier, you know, this technology should be tumor agnostic. The mechanism of action is such that any solid tumor should be responsive to the treatment. And so we are right now sort of exploring what other tumor types would be most amenable to this approach sort of as a next step beyond head and neck cancer. Head and neck cancer was initially chosen for a number of reasons, not the least of which was the accessibility of head and neck tumors to needle injections, which is sort of the requisite first step in these treatment regimens. And so, you know, as we sort of look at other tumor types that might be amenable to a needle injection approach, Some of the advanced breast tumors sort of come up as prime candidates, and we're in active discussions with a group at Emory about a trial looking at gadeptin in certain breast tumor, advanced breast tumor, metastatic breast tumor types. The design of that is still sort of under discussion, and any timing for it The start of such a trial is out in the future at some point, but we are talking to people about this.
spk19: Got it. Thank you for taking the questions.
spk21: Thank you.
spk30: Our next question comes from the line of Jeffrey Cross with Crystal Research. Your line is open.
spk15: Thank you very much. The Bartha agreement for other companies has been extremely valuable in terms of market cap appreciation. When we looked at some of those other companies, the additions to the market capitalization, forget about just the increase in the stock price, has been very powerful for them. How are the discussions going on that front, and do things continue to proceed in the direction that you would like them to be?
spk14: Thus far, we're very pleased with the discussions. We'd love to have received an award letter yesterday or even today that hasn't occurred, but they are very positive, they're encouraging, and we try not to try to model or give out, and certainly we don't think the impact of receiving an award, it'll be very positive, it certainly won't be negative, but we're not speculating what the what the range of that might be. But like everyone else, we're aware of the value of participating and being selected to award in that program. And I'll just say that we have had continued, ongoing, involved discussions that, by and large, are most encouraging.
spk15: Okay. Thank you very much. And with regard to GADEPTIN, we have not seen any other trials significantly advance in that area ahead of providing results that we've seen from your product. Is there any new technology that you see on the horizon that you felt has additional threats, or do you still feel as confident with your technology as you have been given the results you've been able to achieve so far?
spk14: I would say, and then I'll ask if either Kelly or Mark Newman wish to add in, but I'm not aware of any other. There's a lot of work that's going on for head and neck cancer because that's an important There's over 70,000 new cases every year now, and we're seeing now 16,000 deaths. That latter is what we're addressing, at least as our initial indication. I would say the advanced technology may well be the combination therapy of the gadeptin technology in conjunction with the immune checkpoint inhibitors. That may be what would be the next stage advanced technology. Our goal right now is to complete the evaluation of what we hope to be able to announce until yet this half, and then to lay out our plans for going forward and keep everybody updated. But we're not aware of any other technology that's directly coming after what we're focused on right now. We see a lot of good ideas and approaches for earlier stage solid tumors. And in the end, they may very well be highly complimentary, the maybe synergy of those technologies with Gidepton.
spk21: Okay, if no others, I can go to the next question.
spk30: Next question comes from the line of Robert LeMoyer with Nobel Capital Markets. Your line is open.
spk09: I had a question on gadeptin and the clinical trials. I was hoping you could just clarify a little bit of the plans you had mentioned, expansion of the phase two, neoadjuvant, and combinations with checkpoint inhibitors. Are these going to be separate trials that begin in sequence or arms of one trial or just any combination any clarification on how you're looking at all of these potential combinations of gadeptin?
spk31: Sure, I'll ask Kelly to pick up on this one. Yeah, you're sort of focusing on exactly the dilemma that we face and It's a topic that's under active discussion as we speak. We're very encouraged by what we've seen with our Phase I and Phase I-II trials up to this point, particularly in terms of the sort of mechanism of action and translating that into a response that we anticipated seeing in these patients. And so the question then becomes where do we go from here? We put together an advisory committee consisting of a number of head and neck cancer oncologists and head and neck cancer surgeons with whom we're scheduled to meet towards the end of April to discuss exactly the question that you asked. I mean, what's the most logical next step? You know, this is a very, although there's, as David indicated, there's not a lot of competition with regard to our specific technology.
spk14: I think Kelly's having some phone difficulties, but I think we were saying that specifically with our technology, we don't see a lot of competition, but there is a lot going on that's addressing solid tumors, and I'd say they're very novel, all good ideas.
spk31: Eric, with checkpoint inhibitors, should this be an add-on? Should this be a monotherapy to which we then overlay a checkpoint inhibitor? Should we progress into earlier stage disease? All of these questions, I think they're sort of interrelated and we're going to be heavily reliant on the advice of our advisory committee to sort of guide us into where we go next. But the short answer to your question is we don't really know at this point in time.
spk09: Okay, yeah, that's totally fair and relying on the head and neck surgeons who advise you, you know, is a good, a good course of action. So I won't ask you to speculate and I'll just wait for the update after you have that meeting with them. Uh, the, uh, you know, they, they all make sense to me, but it's their opinion that counts more. So, uh, uh, Just in terms of the MPOCs and the NVA manufacturing process, since that's not something where you have a clinical trial or a presentation at a conference, are there any milestones or announcements that we should be looking for that would signal progress in the manufacturing process or the market in that program?
spk21: Let me ask, John Sharkey, would you pick up on that, please?
spk20: Sure. Hey, Robert, nice talking with you again.
spk04: Yeah. Remember, MBA in our manufacturing environment is like a lot of our other vaccines. So as we move forward to implement our MBA production for our different vaccine candidates, such as O4S1 and others at ABL, that platform will be useful also for MBA. Regarding specific MBA milestones, we remain highly confident and optimistic that there is an expedited pathway forward to bring a MBA vaccine for monkeypox and smallpox to the marketplace. We are advancing our discussions with regulators to map that out. and I would expect that we would be updating the market once we have agreement on the plan towards registration. As always, you never get yes, do this, and you'll get it, but you get agreement on how to move something forward. I would expect we would be bringing that forward and sharing with the market this year.
spk21: Earlier, probably even later. Okay, great. Thank you very much for that.
spk19: Next question comes from the line of Jason Colbert with Dawson James.
spk30: Your line is open.
spk08: Hi, guys. Good seeing you recently. I'd like to ask you a little bit about financing. We're in a very tough environment for micro-caps. They've been under a lot of pressure. How do you anticipate raising capital over the coming year? As
spk14: Mark Reynolds, I'll toss that easy answer question to him.
spk17: The simple answer, Jason, is we'll raise funds opportunistically.
spk08: You know, every biotech CEO will tell you we'll raise as much money when and wherever we can.
spk17: You know, we have said in our public filings that we've got cash runway through into Q2 of this year. So you could expect to see some fundraising activity within that time frame.
spk08: And can you narrow in with me on that time frame, what you think might be catalysts that could help drive the stock?
spk14: It's going to be some continued data flow from the trials. It's going to be the most significant item, which is the elephant in the room, is the Project NextGen award from BARDA. You know, we can't count on that because, you know, that's definitely a forward-looking statement to say that we even are contemplating that award.
spk17: But we're very confident in that regard. So I think that would be a significant catalyst for us to look at fundraising upon.
spk08: And remind me how big that award could be and whether that award goes beyond just like a time and materials or is it supply? Just can you go into that a little bit? David, do you want to take that question?
spk18: No, you can go ahead with it.
spk14: The type of award that we expect may come would be, I'll call it a modest amount directly to the company. But the value of the award would be immensely more than what we would receive directly. You call it the biobucks.
spk17: The benefit to the company could be in the hundreds of millions of dollars. But again, that's a forward-looking statement. We'll have to defer to see when an award comes, how it's structured.
spk08: Okay. Thank you very much. It looks like a pretty important catalyst.
spk14: Yes, it is, Jason. Let me just add on. The way that these awards have been coming is that there's a direct award to the company. and that's for the planning of Phase II. Then there will be a direct payment to the CRO that's going to be supporting the clinical program, and that can be $300-plus million in value. So when you see these awards announced, you'll see some of them will announce that they've received this initial award of $10 million directly, but the value that they're receiving is 350 million. So that's how it's been reflected in various press releases.
spk21: Yeah, that's really helpful. Thank you, David. You're welcome.
spk30: Our next question comes from the line of Vernon Bernardino with HC Wainwright. Your line is open.
spk05: Hi, David and team. Thanks for taking my question. You probably saw that ACIP recommended persons over 65 years of age should receive an additional dose of a COVID vaccine. Does the recommendation or any of the language from the meeting change your thinking as far as strategy, market opportunity, or priorities?
spk14: Not at all. If anything, it underscores where we differentiate. because what has been going on, as we've all noticed, and we're seeing, you know, reports from the CDC and others that the famous efficacy of 95%, et cetera, seems to be more like about 50%, depending how you measure efficacy. And we're seeing that durability, which is why we're having to see so many boosters continuously being added, is that the durability of existing vaccines appears to be somewhere between two to four or two to six months. I mean, it just is not the durability versus what was originally communicated, which was that they would be good for a year. And yet we're seeing right now with the data that we're getting out of our trials, durability in excess of eight months. So we right now are seeing data that demonstrate that our durability is about a 2X of what is being noted in the clinical data the clinical use of the current vaccines. There is increasingly more and more publications and statements in addressing the needs of the elderly, depending on how you define the elderly, but also those with the compromised immune systems. It's well accepted that that latter group of people have depleted immune systems because of various medical conditions, that they are at the highest risk of severe disease, hospitalization, and and the risk of death. And this is again where we see with our construct of coming in and having a strong focus on not only on the antibody side, but also on the cellular side, giving what we're seeing right now gives us a broader, almost very agnostic immune response, but also greater durability. We think that as our product is progressing through its clinical trials, there's increasingly more and more evidence of why Project NextGen is such a critical program that the White House announced last year, because it's the recognition that what is out there is inadequate in many different ways.
spk05: Now, as a follow-up, I didn't attend or view the proceedings. I didn't see any mention as far as immunocompromised individuals. Did you gain any insight from the ACA? ACIP meeting about immunocompromised individuals and booster shots?
spk14: Not in the recent meeting, but it's been so well underscored by the CDC, by the WHO, and others that the highest risk groups are those with compromised immune systems.
spk05: Okay, yes. I'm definitely excited for that kind of trial as well. Thanks for taking my question and my follow-up.
spk21: Looking forward to the progress this year. Thank you so much.
spk19: Again, if you have a question, please press star, then one. There are no further questions at this time.
spk30: This concludes our question and answer session. I would like to turn the conference back over to David Dodd for any closing remarks.
spk14: Thank you, and thank you, everyone. We really appreciate your participation in this corporate update call and in joining us and sharing the achievements, progress, and our outlook. And indeed, your interest is greatly appreciated. I want to especially acknowledge and thank our board of directors and advisors, our GEOVAC staff, and the many other parties that continue to support and advise us towards achieving success. In achieving our success, we're committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapies, infectious disease vaccines, and redefining how success is defined in addressing various patient populations. For all of us, it's been a great pleasure serving our shareholders, our stakeholders, and being part of this team. I wish everyone a safe evening and a wonderful rest of the week. Thank you.
spk30: Now concluded. you for attending today's presentation. You may now disconnect.
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