GeoVax Labs Inc. (NASDAQ:GOVX) provided updates on its clinical progress and financial status during their Fourth Quarter 2023 Corporate Update Call. CEO David Dodd outlined the company's advancements in their Phase 2 clinical stage products, including Gedeptin for advanced head and neck cancer and GEO-CM04S1, a next-generation COVID-19 vaccine.
Despite reporting a net loss of $265 million for the year, GeoVax remains optimistic about its technology, potential market opportunities, and ongoing discussions with the Biomedical Advanced Research and Development Authority (BARDA) for Project NextGen funding.
Key Takeaways
- GeoVax is advancing Gedeptin for the treatment of advanced head and neck cancer, with final results expected in the first half of 2024.
- GEO-CM04S1, GeoVax's next-generation COVID-19 vaccine, shows promising interim data and is involved in three Phase 2 clinical trials.
- The company is actively participating in discussions for Project NextGen, a $5 billion initiative for next-generation COVID-19 vaccines.
- GeoVax reported no grant revenues in 2023, with a net loss of $265 million and a cash balance of approximately $6.5 million at year-end.
- Plans to raise additional capital to fund clinical programs are underway, with optimism surrounding potential BARDA funding.
Company Outlook
- GeoVax aims to achieve leadership in addressing unmet medical needs in cancer and infectious diseases.
- The company is targeting patient populations currently unserved by existing vaccine therapies, with an annual U.S. revenue potential of nearly $30 billion.
- GeoVax is confident in exploring additional indications and combination therapies for Gedeptin, including with immune checkpoint inhibitors.
Bearish Highlights
- The company reported a significant net loss of $265 million for 2023.
- Research and development expenses have increased due to accelerated clinical trial activity.
- General and administrative expenses have also increased due to higher costs in various areas.
Bullish Highlights
- GeoVax's Gedeptin technology and next-generation COVID-19 vaccine are showing progress in clinical trials.
- The company is in discussions for a potentially substantial award from BARDA for Project NextGen.
- GeoVax's MVA vaccine manufacturing process is advancing, with plans to disrupt the global monopoly in the smallpox and Mpox vaccine market.
Misses
- GeoVax did not receive any grant revenues in 2023.
- The company's cash runway is expected to last only until Q2 of the current year, necessitating additional capital raising efforts.
Q&A Highlights
- CEO David Dodd emphasized the potential of Gedeptin technology in combination with immune checkpoint inhibitors for treating head and neck cancer.
- Dodd noted the lack of competition for their specific technology and the advisory committee's role in determining Gedeptin's next steps.
- The company discussed the efficacy and durability of their GEO-CM04S1 vaccine, highlighting its performance over existing vaccines.
- GeoVax expressed gratitude for the support and interest in their efforts to redefine success in addressing various patient populations.
Full transcript - Geovax Labs Inc (GOVX) Q4 2023:
Operator: 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. [Operator Instructions] As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gadicke of SternIR.
Max Gadicke: 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 weather. 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 and necessaries 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.
David Dodd: Good afternoon, and thank you for participating in the GeoVax corporate update call. Last year, and more specifically, during the fourth quarter, we successfully advanced our developments, focused on the two Phase 2 clinical stage products while also advancing other critically important initiatives. Today, we'll discuss the progress status and plans related to Gedeptin currently in development as a therapy against advanced head and neck cancer and GEO-CM04S1, 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 and distribution via business partnerships and collaborations. Following my comments, Mark Reynolds, our CFO, will provide an update on 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 Gedeptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care, the 15,000 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 Gedeptin 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 Gedeptin in patients with advanced head and neck cancer. Our strategy also considers Gedeptin therapy for earlier-stage HNSCC 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 Gedeptin as tumor-agnostic, meaning that this 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 are participating in various oncology and partnering conferences and some of which we will present conducting clinical data and with others to conduct partnering discussions. GEO-CM04S1, 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 pathway. This is critically important in addressing the high-risk populations of immune compromised individuals for whom the current vaccines in monoclonal antibody therapies are inadequate. The immune profile generated following receipt of GEO-CM04S1 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 2 clinical trials are underway with CM04S1, two of which address the high-risk populations of immunocompromised patients. The other Phase 2 trial is a evaluating our vaccine as a booster following prior receipt of an mRNA vaccine. We hope to demonstrate that our COVID-19 vaccine substantially 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 2 trial assessing CM04S1 as the booster for the mRNA vaccines. This trial involves 63 healthy adults who had previously received the Pfizer (NYSE:PFE) or Moderna (NASDAQ:MRNA) 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 in the highly virulent Omicron SBB 1.5, as well as demonstrating robust cellular immune responses. Additional testing against the current variant of concern, the JN 1 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, they are 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 vaccine, placing them as significantly increased risk of severe COVID-19 infection hospitalization and potential death. Recently, it was reported in JAMA in February 15 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 individual, and we believe that CM04S1 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 ability to strongly induce both antibody and T-cell responses essential for confirming protection, particularly in immunocompromised individuals. The vaccines article also highlighted the unique feature of CM04S1, providing protective immune levels from the ancestral Wuhan strain all the way through what I mentioned earlier, the highly virulence 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 in 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 of 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 and participating in this clinical study. Following the initiation of patient enrollment in the immunocompromised CLL trial last August, this investigator-initiated trials continue to recruit and enroll patients more recently expanding to additional City of Hope locations. The trial is designed to evaluate CM04S1 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 vaccination 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 CM04S1 can offer these individuals the protection from these buyers that they so desperately need. Results from an interim analysis of the ongoing trial are anticipated during the first half 2024. Relative developing CM04S1 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 on from operation Warp Speed. Seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, particularly insisted in novel vaccine candidates already in clinical trials. We believe that CM04S1 is a prime example of the desired next-generation COVID-19 vaccine. Regarding Project NextGen, we continue with active discussions related to the 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 CM04S1, we anticipate partnering and collaborations and 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, Gedeptin and CM04S1, are focused on patient populations currently unserved by existing vaccine vendor therapies. We believe that the potential of achieving product leadership in addressing the therapeutic and vaccine needs of these respective populations exist 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 the course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. During this year, we will report further progress and results from our CM04S1 Phase 2 programs. And for Gedeptin, we expect to report the final results from the current trial and our plans with the expanded Phase 2 trial. We also expect to report further plans regarding next steps related to evaluating Gedeptin 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 GeoVax to effectively produce and distribute MVA-based vaccine in response to real-time market needs worldwide. To summarize, our various clinical stage products, Gedeptin, CM04S1 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. More we believe the expedited path 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 GeoVax our shareholders and stakeholders. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax's Chief Financial Officer, for a review of our recent results and financial status. Mark?
Mark Reynolds: 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 the accelerated clinical trial activity for our CM04S1 and Gedeptin 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 and administrative expenses were $6 million in '23 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 [$265] million or $14.29 per share versus $14 million in 2022 or $12.36 per share, again, with the increase being driven by clinical trial programs. Now to the balance sheet. Our cash balances at December 31 of '23 were approximately $6.5 million as compared to $27.6 million at the end of 2022. The change in the cash loss 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. Outstanding common shares currently stand at $2.2 million following the reverse split we executed in January this year, which falls us back into full NASDAQ compliance. Funding our ongoing Phase 2 clinical programs for CM04S1 and Gedeptin will continue to be the most significant use of our cash for 2024. We don't expect this prioritization of our spending change if we receive a project NextGen award from BARDA as any incremental spending for that program will be funded by the award. 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.
David Dodd: Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Dr. Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively. I'll now turn the call over to the operator for instructions on the question-and-answer period.
Operator: [Operator Instructions] The first question comes from the line of James Molloy with Alliance Global Partners (NYSE:GLP). Your line is open.
Laura Suriel: Hello. This Laura Suriel on for Jim Molloy. Thank you for taking the question. So with the positive interim results that you already gathered for the Phase 2 trial of your COVID booster vaccine in healthy volunteers, do you anticipate similar efficacy against the newer JN.1 COVID variant? And what other findings might you be expecting from this trial once full top line results are gathered?
David Dodd: Sure. Thank you. This is David Dodd. Thank you for your question, and I'll make some comments, and then I'll ask Kelly McKee, 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 result. Right now, we have no reason to believe that our vaccine would not continue to address the variants, including JN.1, 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 reconfigurations, continued 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.
Kelly McKee: Thanks, David. I think you pretty much covered the waterfront on that one. Yes, we don't have any reason to expect that neutralization of JN.1 will be significantly different from anything that we've seen with the other Omicron variants we've tested. But the proof is going to be in the testing, and we'll have to wait until those test results come back.
Laura Suriel: Got it. And then also for your Gedeptin 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?
David Dodd: Kelly, would you like to address that?
Kelly McKee: Sure. So as was sort of noted earlier, this technology is -- 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 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 a Gedeptin 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 the start of such a trial is sort of way out in the future at some point, but we are talking to people about that.
Laura Suriel: Got it. Thank you for taking the questions.
Operator: Thank you. Our next question comes from the line of Jeffrey Kraws with Crystal Research. Your line is open.
Jeffrey Kraws: Thank you very much. The BARDA 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. All of the discussions going on that front, and do things continue to proceed in the direction you would like them to be?
David Dodd: 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 will be very positive. It certainly won't be negative, but we're not speculating 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 a bit, by and large, are most encouraging.
Jeffrey Kraws: Okay. Thank you very much. And with regard to Gedeptin, 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 feel -- still feel as confident with your technology, as you have been, given the results you've been able to achieve so far?
David Dodd: 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 area. 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 Gedeptin technology in conjunction with the immune checkpoint inhibitors that, that may be what would be the next-stage advanced technology. But 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 complementary. There may be synergy of those technologies with Gedeptin. If no others, we can go to the next question.
Operator: Next question comes from the line of Robert LeBoyer with NOBLE Capital Markets. Your line is open.
Robert LeBoyer: I had a question on Gedeptin and the clinical trials. I was hoping you could just clarify a little bit of the plans. You had mentioned expansion of the Phase 2 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 clarification on how you're looking at all of these potential combinations of Gedeptin.
David Dodd: Sure. I'll ask Kelly to pick up on this one.
Kelly McKee: Yes. That's -- that -- 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 we're very encouraged by what we've seen with our Phase 1 and Phase 1/2 trials up to this point, at least, 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 next -- the question then becomes, where do we go from here? We are -- we put together an advisory committee consisting of a number of head and neck cancer oncologists in 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? This is a very -- although there's -- as David indicated, there's not a lot of competition with regard to our specific technology.
David Dodd: I think Kelly is 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.
Kelly McKee: 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.
Robert LeBoyer: Okay. Yes, that's totally fair. And relying on the head and neck surgeons who advise you is 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.
Kelly McKee: Okay. Thanks.
Robert LeBoyer: The -- they all make sense to me, but it's their opinion that counts more.
Kelly McKee: Yes.
Robert LeBoyer: So just in terms of the Mpox and the MVA manufacturing process, since that's not something where you have a clinical trial or presentation at the conference, are there any milestones or announcements that we should be looking for that would signal progress in the manufacturing process or toward the market in that program?
David Dodd: Yes. John Sharkey, would you pick up on that, please?
John Sharkey: Sure. Robert, nice talking with you again. Yes, remember, MVA in our manufacturing environment is like a lot of our other vaccines. So as we move forward to implement our MVA production for our different vaccine candidates, such as 04S1 and others at ABL, that platform will be useful also for MVA. Regarding specific MVA milestones. We remain highly confident and optimistic that there is an expedited pathway forward to bring an MVA vaccine for 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, earlier, probably even later.
Robert LeBoyer: Okay, great. Thank you very much for that.
Operator: Next question comes from the line of Jason Kolbert with Dawson James. Your line is open.
Jason Kolbert: 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?
David Dodd: I'll ask Mark Reynolds. I'll toss that easy-answer question to him.
Mark Reynolds: The simple answer, Jason, is we'll raise funds opportunistically. Every biotech CEO will tell you we'll raise as much money when and wherever we can. 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.
Jason Kolbert: And if you -- can you narrow in with me on that time frame what you think might be catalysts that could help drive the stock?
Mark Reynolds: 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 We can't count on that because that's definitely a forward-looking statement to say that we are contemplating that award, but we're very confident in that regard. So I think that would be a significant catalyst for us to look at fundraising upon.
Jason Kolbert: 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?
Mark Reynolds: Based on -- David, do you want to take that question?
David Dodd: No, you can go ahead with it. Thanks.
Mark Reynolds: Yes. So it's -- the type of award that we expect may come would be a -- 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. 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 and if the award comes, how it's structured.
Jason Kolbert: Okay. Thank you very much. It looks like a pretty important catalyst.
Mark Reynolds: Yes, very much.
David Dodd: 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 a Phase 2. And then it may -- then if 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 what 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.
Jason Kolbert: Yes, that's really helpful. Thank you, David.
David Dodd: You're welcome.
Operator: Our next question comes from the line of Vernon Bernardino with H.C. Wainwright. Your line is open.
Vernon Bernardino: 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?
David Dodd: Not at all. If anything, it underscores where we differentiate. Because what has been going on is we've all noticed, and we're seeing reports from the CDC and others, that the famous efficacy of 95%, et cetera, seem to be more like about 50%, depending how you measure efficacy. And we're seeing the 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 2x of what is being noted in 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 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, given 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 is 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.
Vernon Bernardino: 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 get any insight from the ACIP meeting about immunocompromised individuals and booster shots?
David Dodd: 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.
Vernon Bernardino: Okay. Yes. I'm definitely excited for that kind of clinical trial as well. Thanks for taking my question and my follow-up. Looking forward to the progress in this year.
David Dodd: Thank you so much.
Operator: [Operator Instructions] There are no further questions at this time. This concludes our question-and-answer session. I would like to turn the conference back over to David Dodd for any closing remarks.
David Dodd: Thank you, and thank you, everyone. We really appreciate your participation in this corporate update call and in joining us in 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 advisers and our GeoVax staff and 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 with cancer therapies, infectious disease vaccine 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.
Operator: It's now concluded. Thank you for attending today's presentation. You may now disconnect.
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