GeoVax Labs, Inc. Q4 FY2022 Earnings Call

Good afternoon and welcome everyone to the GeoVax Fourth Quarter and Full Year 2022 Corporate Update Call. My name is Diego and I will facilitate today's call. With me today are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; 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. Please note, this event is being recorded. I’ll now turn the conference over to our host, Gabbie DeGravina of CG Capital. Thank you. You may begin.

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 vaccines with the desired characteristics in a timely manner. GeoVax's vaccines will be safe for human use. GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's vaccines will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete vaccine development. 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.

Good afternoon, and thank you for participating in the GeoVax corporate update call. Fourth quarter 2022 represented continued progress for GeoVax as we advanced the Phase 2 clinical programs in support of Gedeptin and our promising cancer therapy for patients with advanced head and neck cancers and GEO CMO4S1, our next generation COVID-19 vaccine focused on the unmet needs of immunocompromised patients. We also continue to progress our overall development stage programs. This includes our GeoVax MUC1 immunotherapy currently in IND supportive studies. Also, the preclinical studies evaluating Gedeptin in conjunction with immune checkpoint inhibitors continue to be encouraging, with relevant data expected this year. Throughout 2022, we strengthened our balance sheet during a very difficult investment environment, especially for the biotech industry. As a result of our successful financings last year, we've expanded our current clinical programs to include additional sites while also adding near term opportunities related to our manufacturing processes and additional oncology programs. Recently, we announced the expansion of our Gedeptin Phase 2 clinical program with the activation of patient enrollment in two additional sites at Emory University and Thomas Jefferson University. For our COVID-19 vaccine program, we implemented a novel, mobile clinical research facility in Claremont, California to support our Phase 2 COVID-19 vaccine booster trial. Additionally, multiple sites are in the process of joining our Phase 2 COVID-19 trial among immunocompromised patients, including some potential sites outside the U.S. There is significant interest in participating in the evaluation of our novel COVID-19 vaccine targeting the high-risk immunocompromised patient populations. During the fourth quarter, we also announced the acquisition of the rights from the NIH, allowing GeoVax to develop and commercialize their MVA as a vaccine against monkeypox or MPox and Smallpox. Our intent is to be the first and primary U.S.-based supplier of a GeoVax NDA vaccine against MPox and Smallpox, resulting in expanded supply and access worldwide, especially related to low and middle-income countries, which have consistently experienced significant difficulty in the supply of many critical vaccines and therapies. Finally, we recently announced our successful progress towards becoming the first vaccine supplier using an avian cell line-based manufacturing process, significantly expanding the yield and capacity of MVA-based vaccines. This will allow us to reduce supply chain risk associated with the use of chicken eggs and to provide the means to greatly expand production cost-scale to address potential global needs again, especially related to lower cost alternatives for supply to low and middle-income countries. Our mission is to provide immunotherapies and vaccines that improve lives worldwide, preventing or treating some of the world's most challenging cancers and infectious diseases. Our business strategy of partnering and collaborations is anticipated to allow us to provide worldwide access to our products while providing optimal value to our stakeholders. We believe that Gedeptin CMO4S1 and our other initiatives provide significant value expansion opportunities for the company, our shareholders, and stakeholders while providing compelling career development opportunities for the members of our team. As a reminder, Gedeptin is a cancer therapy currently in an expanded multisite evaluation among patients suffering from advanced head and neck cancers. The product has received orphan drug designation from the FDA, and funding for the current clinical trial is from the FDA orphan drug's clinical trials program. Our focus is on completing the initial 10 patient study funded by the FDA. We will review those results with the FDA along with our recommendations for an expanded program while also discussing with the FDA the potential for an expedited biologics license application filing. We're excited about the outlook and promise of Gedeptin within advanced head and neck cancers as well as other opportunities and indications relative to the expanded use of Gedeptin. This includes the potential application of the underlying technology in conjunction with other therapies such as immune checkpoint inhibitors and potential synergy with our internally developed GeoVax MUC1 tumor-associated antigen approach. Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use for which business development activities have been initiated. The vast array of unmet medical needs within oncology represents significant opportunities for GeoVax to advance novel approaches such as that of Gedeptin therapy against multiple tumors, Gedeptin in conjunction with immune checkpoint inhibitors, and the GeoVax MUC1 cancer immunotherapy approved, addressing various cancer patient needs worldwide. As previously mentioned, we hold worldwide rights for the use of Gedeptin and the GeoVax tumor-associated antigen technologies in all indications. Our plans include the successful development of commercialization globally in conjunction with collaborators and partners. GEO, CMO4S1, which we refer to as CMO4S1, is in Phase 2 clinical development as COVID-19 vaccine targeting both the antibody and cellular arms of the immune system. The goal is to provide a more robust and durable protection than the currently authorized vaccines, especially for immunocompromised individuals. This vaccine holds promise over the current authorized vaccines from several critical areas of differentiation and value to various patients. CMO4S1 is being developed to address those patient populations of immunocompromised individuals currently inadequately served by the authorized vaccines and the various monoclonal antibody therapies. A recent article in The New England Journal of Medicine addressed the critical need to address both antibody and T-cells relative to protection against SARS-CoV-2 infection and COVID-19. CMO4S1 is specifically constructed to include a broader focus on the SARS-CoV-2 virus, including both the spike protein and the nucleocapsid protein, resulting in strong humeral and cellular immune responses. As a result, it induces strong antibody and T-cell responses. Such immune responses were validated and reported last year in the Lancet Microbe publication of the Phase 1 data. Addressing the cellular immune responses via the inclusion of the nucleocapsid protein is especially critical among those patient populations who have immune systems unable to mount an adequate response to antibody stimulation. This includes patient populations with various blood cancers, HIV, sickle cell anemia, kidney disease, autoimmune diseases, and others with various comorbidities. We estimate at least 15 million such individuals in the U.S. alone and over 200 million patients worldwide. We believe that CMO4S1 has the potential to address a critical worldwide medical need and commercial opportunity. We also believe that an opportunity for an expedited regulatory path may exist for such a development program. With CMO4S1, we also anticipate partnerships and collaborations to occur for worldwide distribution, providing a novel vaccine to support patients with such compromised immune systems. Regarding 2023 milestones, our focus this year includes accelerating efforts in support of the Gedeptin and CMO4S1 Phase 2 clinical programs, moving the GeoVax MVA vaccine related to MPox and Smallpox development, and advancing our MVA manufacturing process into operational validation. During the first half, we anticipate reporting initial clinical results of the safety lead in for the CMO4S1 immunocompromised trial. Presentations are scheduled for the World Vaccine Congress in early April, the Vaccine Summit 2023 in late May, as well as the ISAC Flow Cytometry International meeting in late May. In addition to the recently reported side expansion of the Gedeptin study, we anticipate reviewing initial data later this year. Also this year, we anticipate reporting further preclinical information related to the use of the Gedeptin technology in conjunction with immune checkpoint inhibitors. Furthermore, we intend to provide updates related to IND supportive studies of our advancing GeoVax MUC1 tumor-associated antigen therapy. In early June, our team will be actively participating in ASCO 2023. During 2022, we strengthened our balance sheet, adding $37 million during a time when many biotech firms were furloughing programs and/or people. We feel that our capital development success reflects investor support and belief in the value and growth opportunities underway at GeoVax. We continue to receive strong interest related to capital investment development, which we'll evaluate, but we're focused on execution towards our 2023 goals, strengthening shareholder value and achieving critical reporting milestones for our current development programs. 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.

Thank you, David. Starting with our income statement, the first thing to note is the lower grant revenues reported during 2022 as compared to 2021, which is reflective of the wind-down of our grants from U.S. Army and NIH for our loss of fever and COVID-19 preclinical programs, as we focused attention on our clinical programs. We do, however, intend to seek additional non-dilutive government funding for our preclinical development programs in the future. Research and development expenses were $9.1 million for 2022 versus $15.6 million for 2021, representing a decrease of $6.4 million. It should be noted, however, that the 2021 expense included $12.3 million of license fees and other upfront costs related to our licenses of CMO4S1 and Gedeptin. Excluding these costs, our R&D expense actually increased by $5.9 million. These increases were planned and expected as they were associated with new clinical trial activity for CMO4S1 and Gedeptin, including manufacturing costs for clinical trial materials. The increase is also reflective of higher personnel and consulting costs as we stacked up earlier in the year. General administrative expenses were $5 million for 2022, as compared to $3.6 million in 2021, with the increases associated with higher personnel, consulting, and patent costs. So overall, the net loss for 2022 was $14 million or $0.83 per share versus $18.6 million in 2021 or $3.04 per share. Again, the increases during 2022 are primarily associated with the ramp-up of organizational infrastructure and other costs associated with CMO4S1 and Gedeptin clinical trials. Turning now to the balance sheet, our cash balances at December 31 were approximately $27.6 million, compared to $11.4 million at the end of 2021. The change in our cash balances for 2022 is reflective of $19 million used in operating activities, offset by proceeds from stock offerings in January and May with combined net proceeds to us of nearly $28 million and an additional $7.6 million proceeds from exercised warrants during the third quarter of last year. Our outstanding common shares now stand at $26.3 million. In summary, we are well positioned to accelerate and advance our clinical programs with a cash runway sufficient to fund our operations and priority programs to the end of 2023. Funding our three ongoing Phase 2 clinical programs and preparing for the next stages of development are the most significant use of our cash and our top financial priority. I'll be happy to answer any questions during the Q&A. And I'll now turn the call back over to David.

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.

Thank you. And before we take questions, I'm going to hand the floor to Mark Reynolds for some comments. Thank you.

To take a minute to tell all the listeners that what you just heard was prerecorded by David and me. Unfortunately, David had an unexpected family emergency today and he is going to be unavailable to participate in the last Q&A session. But I still have with me today, Mark Newman, John Sharkey, and Kelly McKee, and we'll all do our best to answer any questions that may arise. So I'll turn it back to the operator now.

Thank you. We will now start our question-and-answer session. Our first question comes from Jason Kolbert with Dawson James. Please go ahead with your question.

Hi, guys. Congratulations on all the progress. A couple of questions across a couple of areas. First on Gedeptin, at what point do you think you'll hit proof-of-concept? That's what I'm trying to understand. In the Phase 1/2 trial, at what point do you walk away and say, yeah, this thing works?

Mark or Kelly, which one of you will take that question, please.

Well, this is Kelly. Let me sort of start off. That's really kind of a hard question to answer. We have proof-of-concept in a general sense from the Phase 1 study that's already been completed in that we demonstrated that injection of tumors with Gedeptin and followed by fludarabine infusions shrink the tumors. Now, this is palliative therapy, so we have no expectation that we're going to improve overall survival or even necessarily lengthen survival, but we do have proof-of-concept already that this technology will shrink tumors. The current study is designed to follow up that initial trial by giving repeat administrations of Gedeptin and repeat with fludarabine. Patients are following to activate the protein inside the tumor, and we will assess not only the safety profile with repeat administration, but to see whether we're seeing an accelerated or expanded benefit in shrinking tumors. It's a small number of patients. We've now enrolled eight of our target 10 and once that study is completed, as we start looking at all the data qualitatively as well as quantitatively, I think we will have a better sense for that and that information should start to become available towards the end of the summer, given the timelines of the trial itself. Does that help answer your question?

Yeah. No, that does. I mean, it establishes the timeline. We get it. We're going to get to 10 and see what the data looks like. What's the best case scenario that you'd like to see?

Best case is we take our data package to the FDA and they look at it and tell us, well, if you can give us similar data in a reasonable number of patients. We don't know what that number would be. We were initially hoping it would be somewhere in the neighborhood of 20 to 40, but it's probably going to be more than that. But then we could achieve an accelerated approval for this as an unmet medical need. But again, it sort of depends on what the data looks like when we finish the trial and what the environment at the FDA is in terms of accelerated approvals for these kinds of therapies at the time that we present to them.

Okay. Fair enough. Understood. A similar question on the COVID-19 vaccine program. Two Phase 2 trials; what's the next focal point that we should be looking at in terms of that data set?

Well, so the two trials that we have ongoing, one of them is in healthy volunteers as a heterologous booster and we're about between a third and halfway through enrollment. With the addition of our new clinical site, we anticipate accelerating enrollment dramatically and hope to have that study fully enrolled within the next couple of months at worst. Given the follow-up, the primary immune marker endpoint is a month or so after the booster. So we should start seeing some of that data hopefully by the third quarter of this year. The study we have ongoing in patients with hematologic malignancies is a much slower-paced study. We've not been able to enroll that study as quickly as we had anticipated at the City of Hope National Medical Center where it was begun. For that reason, we've begun enlisting support from multiple other academic medical centers. By summertime, we should have a handful of those lined up to enroll patients. So I wouldn't anticipate any significant readouts for my best guess for about a year or so, just because it's difficult to find patients that meet the eligibility criteria for this trial.

Okay. Fair enough. And my last question is really understanding the importance of the MVA manufacturing process. What I'm thinking here is that in the event that there is another pandemic, the ability to quickly scale capacity and high yield becomes critical, obviously. You're differentiated from an mRNA process, which is a pretty rapid process too, but you're making the point that you're moving away from egg-based vaccine technology, which is something in the past, and you've now kind of got this critical piece in place. Is that understanding correct?

Yeah, it's Mark Newman. Let me comment on that one. Sure. Yeah, that is the goal here. The mRNA is a platform, as you mentioned, where it really enables you to do a rapid response. So there's a difference between a response and building a vaccine capability. The cell line production gives us large scale, but it's also the idea of getting back to the kind of normal world of vaccines where childhood vaccines are given at a young age and you hope never to get sick the rest of your life. That's what we're looking at for our products. So larger scale manufacturing would be needed to meet that type of distribution. So we're focused on COVID, so you're always being compared to the mRNA vaccine groups, but we're targeting that field totally differently. So it’s we can be small scale and certainly address with the current technology smaller niche types of patient populations, but really expand it, which is what's in our plans that will fit into the cell production-based systems.

Yeah. Thank you. That really clears it up for me a lot. Congratulations on all the progress. I hope David as well. Thank you.

Our next question comes from Vernon Bernardino with H. C. Wainwright. Please state your question.

Hi. Thanks for taking my question. Most of them have already been asked and answered. But I just wanted to follow up on Jason's question regarding Gedeptin. Now, regarding the kind of efficacy that we might expect from the Phase 1/2, you mentioned that eight patients have been enrolled and perhaps expect some data at the end of summer. But what kind of data would that be? Would that be just data in which you confirm that Gedeptin shrinks tumors, or is there some kind of efficacy data you expect to announce?

We are measuring our endpoint measures and have graded these tumors under RECIST 1.1, and we will be taking tumor measurements. We will examine not only the quantitative impact on injected tumors but also the potential effect on distant tumors that were not injected. This will help us gain confidence that what we are doing is genuinely benefiting patients in a meaningful way, particularly in improving their quality of life. Additionally, it will inform our direction for follow-on studies. We will definitely need to include more patients beyond the ten we will have at the end of this trial. However, whether this will allow us to increase the amount of fludarabine provided to patients to facilitate more activation of Gedeptin within the injected tumor masses, or whether we can adjust the volume of injected adenovirus that delivers the activated protein to the tumors, remains to be seen. These questions will guide us as we proceed with additional patients. Does that clarify things for you?

Yes. And as a follow-up, do you have any expectations on how many repeat cycles may be possible, especially when you're also giving fludarabine?

Each cycle currently includes the injection of Gedeptin through three injections over two days, followed by three days of fludarabine. Patients can undergo up to five cycles. We are uncertain whether additional cycles could be added or would be beneficial. This is something we plan to investigate as we move forward in the development program, but we do not have sufficient information at this time to make that determination.

Perfect. And do you expect to discuss data from the 10 patients with the FDA? Do you think that will be this year?

Yeah. I mean, we are obviously constrained by how quickly we can enroll these final two patients, and if these final two patients follow the entire lifecycle program, we're looking at basically six months from the time that the last patient is enrolled. So give us a month or so to analyze the data and pull it together, schedule a meeting with the FDA. We’re hoping we'll be able to get in front of them by the end of the year, but there are some factors that are sort of beyond our control in that regard.

Perfect. That's very helpful and thanks for taking my questions.

Our next question comes from Jason McCarthy with Maxim Group. Please state your question.

Hi, this is Joanne Lee on the call for Jason McCarthy. Thanks for taking the question. Just two from me, as most of my questions have already been answered. But firstly, I guess from a broader perspective, do you guys have any numbers on, I guess, the proportion of patients who are getting regular boosts and revaccination? Would you expect this to be sort of the addressable population for your vaccine? Curious to hear your thoughts.

When you mean patients, you mean our hematologic malignancy population or who are you talking about specifically?

For the COVID, related to the COVID vaccine, I guess how many people are up to date and actively getting boosters and I guess, if your COVID vaccine that you're currently developing would be addressable to this population of patients?

Well, I mean, I would anticipate that, given the impact that this disease can have on an immunocompromised population of patients, virtually all of them will be getting regular boosters with mRNA vaccines according to the schedule prescribed by the CDC and the cancer societies, but we don't have any specific numbers on that. What we do know is that the response that these patients generate to mRNA vaccines is suboptimal compared to that seen in normal healthy individuals and that they remain vulnerable to contracting severe illness when they get infected with this virus.

Great. Appreciate the color. And moving on, I guess, to the head and neck cancer trial, how large do you think the trial will be in terms of enrollment and what kind of response rate do you think would be clinically meaningful to advance the program? Thanks.

Well, yeah, you've just asked the two questions that we're going to be curious to hear from the FDA about. We don't really know right now what they're going to require in order for us to be granted an accelerated approval. We have some estimates from some of our consultants that range anywhere from 80 to 120 patients. But whether that's really what they're thinking right now, we don't know. In terms of what sort of endpoints or what sort of readouts. Again, we don't know what they're going to require. Our meeting with the FDA will solicit input from several regulatory specialists that have been working in this area to give us thoughts and recommendations about what to present and what to propose.

Got it. Appreciate you taking the time to provide updates. Congrats again on the quarter.

Our next question comes from Robert LeBoyer with Noble Capital Markets. Please state your question.

Good afternoon. I was hoping that you could discuss some of the things in the Gedeptin trial and specifically the use of the checkpoint inhibitors that was mentioned earlier. It was a mention of the dosing regimen, but I was curious as to whether you were going to have separate arms for the checkpoint inhibitors for all patients or how you are going to go about testing Gedeptin either alone or in combination?

Yeah. So, I mean, fundamentally, we don't have a study design specifically in mind at this time. However, we recognize the potential that adding a checkpoint inhibitor offers to a therapy like Gedeptin. I mean, there's a plausible biological rationale for doing this. There are other therapeutic agents in trials in head and neck cancer that are capitalizing on this concept at the present time. We have some ideas about how to go about doing this, but we don't have any specific design in mind at this time. The preclinical work that's ongoing is with our collaborators at Emory University. They have demonstrated in animal models some very encouraging results, which I think support moving forward and how to proceed. Our thinking at this time, and I stress this is not a commitment, but it's that offering Gedeptin plus a checkpoint in the context of new adjuvant therapy is a very appealing approach and we intend to explore that extensively as we discuss moving the program down the road in multiple different directions.

Okay. Thank you very much.

Thank you. Our next question comes from Kumar Raja with ROTH Capital. Please state your question.

Thanks for taking my questions. The first one regarding the MUC1 IND filing, what needs to be done there before and also the timing? And with regard to the Gedeptin trial, what are you seeing in terms of screen failure rate? What should we expect in terms of data at ASCO?

Well, I'll take the Gedeptin question and then Mark will address the MUC1 question. So we're not presenting anything at ASCO. I am going to that meeting to avail myself of the opportunity to interact with many of the key opinion leaders in the head and neck cancer field to seek insight into the state of the art with using therapeutic interventions alone or in conjunction with checkpoint inhibitors and other immunologic stimulants. So there will be no data presented at ASCO because we don't really have a complete data set to present. What was your other question about Gedeptin before I give it back to Mark?

Yeah. I was wondering what you're seeing in terms of a screen failure rate there?

Screen failure is a complex issue. The patients referred to us by our site investigators are typically at the end of their other treatment options. They are usually pre-identified well in advance of being ready to participate in our trial. Some may respond to their current treatment, while others might not qualify due to serious complications like abnormal blood chemistries or cardiac issues. This situation varies widely, so we don't see patients screened until the investigator believes there's a reasonable chance they can enroll. Once they reach that stage, I would estimate our screen failure rate to be around 25% to 50%.

Okay. That's great.

Thank you. Our next question comes from Jeffrey Kraws with Crystal Research. Please state your question.

Thank you very much. Many of my questions were already asked. But the questions remain, you just addressed ASCO, but do you expect to present any scientific papers or scientific presentations or data set presentations at any of the three scientific conferences that you're attending?

For Gedeptin or for...

For anything.

Yes. We're just not at ASCO. We got there too, yes. There's going to be data presented at the World Vaccine Congress in early April. There's going to be data on CMO4S1. Data will be presented at the Vaccine Summit in Boston in late May on CMO4S1, and then there's a Flow Cytometry Conference in May where some data from the lab, which is more technical lab stuff associated with our trial, is going to be presented as well.

Fantastic. I know you've been working very hard to move that along. So that's great news. The second question is, with regard to the manufacturing and having that as one of your goals, if one was to look at your manufacturing validation and just say you hope to have it by a certain date, what would you say the percentage of working towards that is complete now? I'm not asking you for what the specific guide is; just roughly.

Mark, John, that's yours.

We have various viral vector vaccines in development. In the Ebola field, we have O4S1, which represents our initial step towards a universal COVID vaccine. We are evaluating each of these with different cell lines for their expression systems, which is a step-by-step process. The initial requirement is to confirm that a specific virus can grow in a specific cell line, which doesn’t always happen. Sometimes the result may lead to toxicity. These cell lines can be derived from ducks or chickens, and they consist of tumor cell types, albeit with slight genetic differences depending on their avian source. We systematically determine which cell lines are compatible with which viruses. For O4S1, we have reached a point where we are comfortable with our choices and could proceed with production based on various manufacturing technologies available to us. Currently, we are discussing business arrangements, and while I can't share detailed information at this stage, we are prepared to move forward. Additionally, we have another candidate still in the mouse model that has potential for a secondary universal COVID approach, but our primary focus remains on O4S1. Each of these products is likely intended for specific paired systems, and while it would be ideal to find a single manufacturer and cell line that can cover all our needs, we recognize that variations exist. We are taking all necessary steps for each product, and for these leading candidates, we are ready to make decisions.

Perfect. That would be a better approach and compared to what you said. One final question is, you're seeing a lot of interest and a lot of movement out there amongst pharma companies, at least in our coverage of pharma. We're seeing still strong interest in partnering with novel companies with unique and differentiated technologies that are game-changers. You're still seeing a lot of interest for potential partners?

Yes, I'll take that. Hey, Jeff. Thanks for your question. I was recently at the Bio Spring European Partnering meeting in Basel. We began discussions with companies last year about the Bio initiative. I'm noticing increasing interest in our efforts. Many people understand the mission we're pursuing, but there is some fatigue within the population regarding COVID. I often get asked if we need another COVID vaccine. However, when we look at patients who are immune compromised, the current vaccines fall short in providing adequate protection for them. I can't definitively say that someone will jump on this, but I do see that people are engaging with us and following up. We are successfully demonstrating the real need in this area, and there are numerous appealing opportunities. These patients are often under active treatment and managed by specialists, making them more accessible for identification and engagement. There are many advantages from a commercial standpoint in focusing on this space.

I appreciate your insights. Thanks for taking the questions. Keep up the good work. Thank you.

Thank you. There are no further questions at this time. I'll hand the floor back to Mark Reynolds for closing remarks.

Yes, thank you. I just want to conclude the call by thanking everybody for participating. Your interest really is greatly appreciated by all of us. Our focus for this year, for 2023, is on execution, on reporting updates and progress for our Gedeptin and CMO4S1 clinical programs, as well as the other development programs we have underway. For all of us, it is a great pleasure serving the shareholders, and I say that truthfully in being part of this team. So with that, I'll conclude and I'll just tell everybody to have a good day. Thank you.

Thank you. This concludes today's conference. All parties may disconnect. Have a great evening.