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spk06: Good day. My name is Jordan, and I'll be your conference operator today. At this time, I would like to welcome everyone to the GeoVax second quarter earnings conference call. I'll turn the call over to Gabrielle.
spk01: 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 that force 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?
spk02: Good afternoon, and thank you for participating in the GFX corporate update call. This year, we've expanded patient enrollment in support of the GADEPTIN Phase 2 clinical trial and the two Phase 2 trials for GEO-CMO4-S1, as well as announcing the initiation of the third Phase 2 clinical program, evaluating this next-generation COVID-19 vaccine as a booster among patients with chronic lymphocytic leukemia. We also recently expanded our rights related to CMO4S1 to include Omicron variants, monkeypox, and smallpox, further differentiating our COVID-19 vaccine. While the clinical development progress of GADEPT and CMO4S1 remain our priority, we are also focused on GEO-MVA, our vaccine against monkeypox and smallpox, as well as the implementation of the transformative MVA continuous cell line manufacturing process. During the second quarter, we progressed each of these priority initiatives. Currently, we are funded into 2024, and we anticipate further strengthening our balance sheet as a result of supportive stock activities, business development initiatives, and non-dilutive opportunities related to government and NGO funding. As recently announced, interim data from the current Gidepton Clinical Program was presented in July at the American Association for Cancer Research and the American Head and Neck Society joint conference on head and neck cancers. We are pleased and encouraged by the results, noting no dose-limiting toxicities or serious adverse events definitely attributable to treatment, with impaired growth in targeted lesions observed in the majority of the patients. We anticipate completion of the current clinical program shortly, and we are already planning the next stage of clinical development relative to this promising therapy. There are approximately 67,000 new cases of head and neck cancers annually in the U.S. and approximately 13,000 deaths. This represents our initial targeted patient population. Worldwide, there are approximately 900,000 new cases of head and neck cancers annually and approximately 400,000 deaths. Patients suffering from advanced head and neck cancer represent a critical unmet medical need. We are excited about the outlook and promise of gadeptin therapy against numerous tumors and cancers. We foresee significant opportunity addressing various tumors as monotherapy, as well as the potential combo therapy, administering gadeptin in conjunction with other therapies, such as immune checkpoint inhibitors. We anticipate publication of compelling preclinical evaluation of gadeptin use in combination with ICIs later this year. Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use for which business development activities have been initiated. We hold worldwide rights for the use of Godeptin and all indications. The vast array of unmet medical needs within oncology represents significant opportunities for GFX to advance novel approaches addressing various cancer patient needs worldwide. Increasingly, we are participating in various oncology conferences some of which we expect GADEPTIN presentations, and with others, GADEPTIN partnering discussions. GEOCMO4S1, our next-generation COVID-19 vaccine, differentiates from the currently authorized COVID-19 vaccines in targeting both the antibody and cellular arms of the immune system, focused on providing a more robust and durable protection than the current vaccines. 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. Such populations include those with various blood cancers, renal disease, sickle cell anemia, HIV-positive, autoimmune diseases such as lupus, and those on immune-suppressive therapy. In general, patient groups with ablated immune systems unable to respond adequately to approved mRNA Vaccines are at such high risk. In the U.S., there are approximately 12 to 15 million immune compromised individuals. Worldwide, there are an estimated 200 plus million. This 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. During second quarter, the White House announced Project NextGen, a $5 billion initiative, the follow-on from Operation Warp Speed, seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, being particularly interested in novel vaccine candidates already in clinical trials. We believe the CMO4S1 is a leading example of the desired next-generation COVID-19 vaccines. We have considerable interest both domestically and internationally in participating in our clinical development program. We believe that an opportunity for an expedited regulatory path likely exists due to our focus on high-risk populations unserved by the current COVID-19 vaccines and monoclonal antibody therapies. Also, we anticipate partnering and collaborations in support of worldwide commercialization and distribution. Regarding Project NextGen, all we can say at this time is that we're deeply involved in the process and discussions. We hope to provide further updates soon. For the remainder of 2023, we are focused on accelerating efforts in support of the Depton and CMO4 S1 Phase II clinical programs, advancing our MVA vaccine specific for mpox and smallpox into development, and further advancement of our program focused on improved MVA manufacturing processes. We also anticipate opportunities to add additional capital in support of these programs, accelerating the pace of progress and reporting a milestone in capital. 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?
spk10: Thank you, David. Starting with our income statement, I'll focus on the comparative figures for the six-month periods of 2023 versus 2022. We had no active grants during 2023 so far, so we reported no grant revenues as compared to a small amount in 22. I'll note, however, that as David suggested, we are actively seeking additional non-dilutive funding for both our preclinical and clinical development programs, and we expect this may potentially be a very important component of our financing fix in the future. Research and development expenses were $7.5 million in 2023 versus $2.6 million in 22. with the increase primarily associated with clinical trial activity for the CMO4S1 and Gdeptin programs, including main traction costs for clinical trial materials. The increase is also reflective of higher personnel costs as we brought on two additional executive-level employees this year, which added depth to our regulatory and quality control functions. General and administrative expenses were $2.9 million in 2023 versus $2.1 million in 22, with the increase mostly associated with higher personnel, consulting, and patent costs. So, overall net loss for the first six months of 2023 was approximately $10 million, or $0.38 per share, versus $4.7 million in 2022, or $0.47 per share, again, with the increase being driven by the CMO4S1 and GADEPT and clinical trial activity. Turning now to the balance sheet, Our cash balances at June 30 were approximately $18 million as compared to $27.6 million at the end of 2022. The change in the cash balances is reflective of $9.8 million used in operating activities. There were no significant financing or investing activities so far during 2023. Our outstanding common shares stand at $26.4 million. Funding our four ongoing Phase II clinical programs is the most significant use of our cash and our top financial priority. But I'll note that the recently initiated fourth trial, that being for CLL, is being fully funded, primarily through non-dilutive sources, with GEOVAX providing some relatively minor support for analytical costs. Our cash runway is sufficient to fund these programs through the milestones expected to occur through the end of this year and into early 2024. So I'll be happy to answer any questions during the Q&A, and I'll turn the call back now to David.
spk02: 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. I'll now turn the call over to the operator for the instructions on the question and answer period.
spk06: At this time, I would like to remind everyone in order to ask a question, press star then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster.
spk00: Your first question.
spk06: comes from the line of Robert Laboya from Noble Capital Markets.
spk08: Hi, and congratulations on all the progress that you've made in the past quarter. My question has to do with your mention of a combination trial with the checkpoint inhibitors. And I was wondering if there was any data that was going to be presented or any plans for the rest of the year You had mentioned expansion of the current trials and completing enrollment, but I was wondering if there was any intention to start another arm or what the potential for combination therapy is right now.
spk02: Sure, Robert. This is David. I'll answer, and then Kelly, if you want to add anything else. What I would say is right now it's in preclinical work. We're supporting that work. of the evaluation of gadeptin in conjunction with ICIs. There is a manuscript that's in development. Again, this is preclinical work that we anticipate that manuscript will be published yet. Our guidance and understanding is yet this year. And we'll continue to evaluate it. But at this time, we're not working in the clinic in any combo therapy. We're focused right now on the current clinical program. Kelly, do you want to add anything to that?
spk05: Sure. I mean, you know, one of the really exciting things about cadeptin is that its mechanism of action is essentially, you know, tumor agnostic with respect to solid cancers, solid tumor cancers. And so, you know, I think we have an opportunity to sort of survey the cancer landscape, if you will, and target, you know, a number of different tumor types. And in that regard, you know, we're exploring sort of next steps in the head and neck cancer space, but we're also in discussions with some academic investigators who have expressed an interest in looking at gadeptin in breast cancer patients. And if we proceed in that direction, I think the likely opportunity will be for us to go in with a combination gadeptin checkpoint inhibitor trial. the design of which is, again, sort of in the early phases of discussion, so really can't go into details on that. But that's probably going to be our next non-agent head and neck cancer target.
spk00: Thank you. Okay, thank you very much. Thank you, Ron.
spk06: Your next question comes from the line of Kumar Raja from Roth Capital.
spk04: Thanks for taking my questions. So I had a question about the booster trials. In terms of data, when can we expect data from this trial? Will we have any interim data from this trial?
spk02: Kumar, are you asking about the Healthy Volunteer Booster or the booster for the CLL patients?
spk04: I'm asking about the CLL trial.
spk02: Okay.
spk04: Kelly, you want to address that, please?
spk05: Yeah. So the CLL trial just began enrolling a couple of weeks ago. And so it's still in the early phases of study. The expectation, based on our discussions with the principal investigator at the City of Hope Medical Center and their team, is that we'll have that trial fully enrolled within about a six-month period. Now, the primary readout is a month or so after the second vaccination, which is three months after the first vaccination. So you sort of do the math, and I think you're likely to see at least an initial view of outcomes, of immunologic outcomes and safety outcomes, you know, sometime toward the end of 2024, early 2025. You know, the study itself is a follow-up period of a year, so it won't be completed for, you know, 12 months after it's fully enrolled, so whenever that time point hits. Does that answer your question?
spk04: Yeah, what I'm trying to get into is, like, you know, will you be waiting for all these AT patients to be enrolled, or will you be releasing some data jobs? Let us say data from like 40 patients or something like that will you be, you know, providing the same update in the interim.
spk05: Well, you know, again, remember this is an investigator-initiated study, and so the sort of operational control of this trial is under the investigator himself. And, you know, we are fully informed of progress as the trial proceeds, but as to when specific data will be forthcoming, you know, I can't answer that at this time.
spk04: Okay. And with regard to this manuscript you are preparing with the checkpoint inhibitor, what kind of preclinical models are being used there? And also, is there expectation like how gadaptin will be sequenced with the checkpoint? First you'll use gadaptin and then followed by the checkpoint inhibitor?
spk00: Well,
spk05: So the manuscript is being prepared by our academic collaborators. And this is based on their work in a mouse model, mouse tumor model. And, you know, the specific details of that, you know, I'm not at liberty to disclose. But it will guide the design of our clinical trial. I think you can, we can say that with some confidence.
spk04: Okay, and mostly this data will be in head and neck cancer models as well as breast cancer models. That's my understanding.
spk05: Is that accurate? I'm not sure. I haven't seen the draft manuscript, so I'm not sure exactly what is being put in there, but I do know that they have data from at least breast cancer, a breast cancer tumor model, and additional tumors but I'm not sure what additional tumors those are. John Sharkey, do you have that information?
spk03: Yeah, hey, Kumar, my understanding is they've looked at a couple of different tumor types. They've looked at a glioblastoma. As Kelly said, they've looked at a breast cancer. Which ones they're going to include in this publication, we're just not aware, privy to until we see the first draft of this. They're in preparation and internal circulation within their institution at the current time.
spk04: Okay, okay. And with regard to the head and neck, has all the 10 patients been enrolled in the trials? What can you share with regard to that?
spk05: No, we're still a couple of patients short of our target, enrollment target. And we... I know what you really want to know is when we're going to finish complete enrollment. We're hoping that that's going to take place before the end of the year. We found this to be a very, very difficult patient population to enroll for a whole variety of reasons, but we're confident that we'll be able to close out this study by the end of the year.
spk04: Great. Thanks so much for taking my questions.
spk02: Good. Kumar, let me just add, on the CLL study, I did want to point out that the vaccinations have already begun. It was just recent. A couple weeks ago, we announced initiation of it. But there appears to be a strong building, I'll call it cube, of CLL patients interested in this. So the vaccinations have already started, and there's quite a nice screening buildup. They're in the background. And so the concept of this being fully enrolled within six months does not mean it'll be six months. I mean, we'll have to monitor the pace of it because it is an investigator-initiated trial. And our anticipation is that we will be learning of data as we go through it, not simply waiting until the full ADR completed.
spk00: Okay, great.
spk06: Again, if you'd like to ask a question, press star, then the number one on your telephone keypad. Your next question comes from Jeffrey Krause, Crystal Research Associate.
spk09: Thank you very much. Two of my questions were already answered, leaving just one. With regard to the CMO4S1 and the Omicron variants, this is actually, you know, I would think a technology well COVID has died down, given smallpox and some of the issues they're having in other countries. Are you seeing good response following that data that you presented, showing both the T cell response as well as an immune response?
spk02: Yes. I'll ask if Mark Newman would like to weigh in on this, because we've seen very promising and encouraging response with our vaccine against the Omicron and Delta, basically all the way through XB1.5. But Mark?
spk07: Yeah, sure. Thank you, David. You know, we have samples in the freezer from, you know, the phase one, and then we have what will be called the safety lead-in or the sentinels in the blood cancer studies that are evaluated in real time. And so one of the things you always do is go back and look at your samples and ask, well, okay, how did it work against the Wuhan where we started? How does it work against Delta? How does it work against Omicron? And in fact, what we're finding, and this has been presented at a couple of vaccine meetings, is that we're getting great booster responses even in the cancer treatment patients. In fact, I would say surpassing initial expectations. This includes an increase in antibody responses that neutralize the variants from the original Wuhan through the Delta and into some of the Omicrons, including Omicron vaccines about BA 1.2 and 1.5. So we're always a little bit, I would say, behind, maybe three to four weeks behind. It takes that long to make the new constructs up. But it's very promising data in that we're seeing neutralization across to these other variants. And, of course, we're seeing T cell recognition to both the S and the N maintained at a high level. That was actually predictable because the virus is not varying the T cell epitopes as much as it's varying the portion that the antibodies is recognizing. So, yeah, it's all pointing in the right direction.
spk09: Now, on the, you know, looking at the populations with the various blood cancers, et cetera, as well as sickle cell, it's not widely recognized. While the sickle cell population in the United States is less than 200,000, the sickle cell population in India is estimated to be 28 million. So that is an area I think you would have a lot of interest for, not only partnering, but a lot of interest for patient population treating because it's such a large market for them.
spk02: That's true. Numerous groups within, I'll call it the immune-compromised population, people are still being sequestered in the United States who are CLL patients. people being sequestered to other parts of the world, whereas the rest of us, we barely remember wearing a mask, it seems like. We're going about our lives. But there are these populations who have these medical conditions for whom the current vaccines and monoclonal antibodies are inadequate. And they're not leaving. They're not back to normal lives. They're still sequestered, being kept indoors. And that's why we saw a strong response and interest with the Announcement of the initiation of the CLL booster trial.
spk00: Perfect. Thank you very much for the updates. Thank you.
spk06: There are no further questions at this time. I would like to turn the call back over to the presenters.
spk02: Thank you. Thank you, everyone, for participating in this corporate update and sharing in our achievements, progress, and outlook. We're quite excited about what we're learning with these products. Bdeptin is continuing to show promise and encouragement, not just in head and neck cancers, but in the application of other areas. We think there's broad-based opportunity there. We'll keep you updated as more data comes in and as we learn more about that. CMO4S1, as Mark Newman mentioned it, It's exceeding probably expectations in terms of the promise and what we're looking forward to. We're highly encouraged with the interest we've received from various parties about that product and the opportunity, the broad-based use of it. Again, we'll keep you updated as more data comes in. And at the same thing, as we progress with our MDA vaccine to become the first U.S.-based supplier of such a vaccine and help the world supply, et cetera, And then, of course, our manufacturing process improvements. So we'll keep you updated. Our focus is only accelerating to these milestone catalysts. Our goal is to deliver critically needed vaccines and immunotherapies to build shareholder and stakeholder value while providing highly motivating career development opportunities for our team. We take that very seriously. We want to acknowledge and thank our board of directors, our staff, and the many other parties who continue to support advise, counsel, and assist us as we move forward. So thank you for your interest. Please circle back if you have further questions. We appreciate your time, attention, and interest. Thank you. Have a good day.
spk06: This concludes today's conference call. You may now disconnect.
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