Full transcript - Life Sciences Virtual Investor Forum Conference:
Moderator: Hello, and welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you have joined us. The next presentation of the day is from CytoDyn. Please note you may submit questions for the presenter at any time. You can also view a company’s availability for one-on-one meetings by clicking "Book a Meeting." At this point, I am very pleased to welcome Robert Hoffman, Chief Financial Officer of CytoDyn, which trades on the OTCQB Venture Market under the symbol CYDY. Welcome, Robert.
Robert Hoffman, Chief Financial Officer, CytoDyn: Thank you, Lily. I’m excited to present at the Life Science Virtual Investor Forum. Before I begin, I’d like to point out that I’ll be making numerous forward-looking statements during this presentation. Actual results may differ. Please refer to our risk factors on file with the SEC. As background, CytoDyn is a clinical stage oncology company. We’re advancing our molecule, leronlimab. It is a first-in-class humanized monoclonal antibody. We do target the CCR5 receptor with therapeutic potential across multiple indications. Our lead program is in metastatic colorectal cancer. We also have a program in breast cancer, and we’re looking at other solid tumor indications. Just taking a step back, we really try to keep integrity, responsibility, and service in everything that we do at CytoDyn. I like to say that we keep the activities we do with the patient as the center of everything we do.
Just thinking about designing clinical trials, start my timer. Designing clinical trials, we try to design the best study for patients to get the best outcome. I believe that also creates shareholder value, because we’re doing it in the best way possible. It helps the FDA, and it also helps potential partners to get the best data that we can out of any study that we do. In terms of our leadership, we have Dr. Jacob Lalezari, who’s been CEO since November of 2023. Lots of clinical experience with leronlimab, which comes in incredible helpfulness when we’re looking at clinical trials and other indication. Myself, I’ve been CFO for a little over a year now. Prior experience includes about 17 years at Arena Pharmaceuticals, which ultimately got acquired by Pfizer, and I sit on a couple outside boards, including FibroBiologics, as well as Tahoe Therapeutics.
Just a quick look at an executive summary. As I mentioned, leronlimab is a novel drug candidate. We have multiple demonstrated mechanisms of actions. We’re looking at some very large market opportunities for us across colorectal cancer. You’ll see a slide on that in a little bit. Triple-negative breast cancer, as well as other solid tumor indications would include pancreatic cancer, for example. One of the hallmarks of leronlimab is it’s a very well-tolerated drug candidate. We have extensive database of safety, including approximately now we updated this to 1,700 patients, enrolled across 20 plus different clinical sites. So that’s really something I think differentiates our drug candidate from a lot of other drug candidates in terms of the safety profile that we have, especially in cancer patients who are ill to begin with. Being able to check off that safety component is really, really helpful.
We do have very strong retrospective clinical data in triple-negative breast cancer. I will talk about that in a little bit. Then we have our early readouts from our CLOVER study in metastatic colorectal cancer. Then some multiple near-term milestones, including confirming the safety and durability efficacy readouts from our phase II CLOVER study. A presentation at ESMO. I will talk about that in a little bit, as well as a presentation at ASCO GI in January of 2027. Now let us turn to our colorectal cancer and CLOVER study, in particular. We are looking to confirm the-- before I get into that, actually to the next slide. The study really enrolled extremely quickly. You can see the first patient was dosed in June of 2025. We completed enrollment in April of 2026, less than one year.
We heard from our CRO that this was a really fast-moving enrollment that they have seen, in particular. I attribute that to, we heard back from a lot of the physicians treating these patients that after just a couple weeks, that it is more anecdotal, but they felt better. These patients felt better, and then the physicians also told us that they were prescribing a lot less pain medications. That really goes to show that word got around, and these clinics actually started enrolling patients much quicker than we had anticipated for sure. The Data Safety Monitoring Board has met three times now. First meeting there was to open up the 700 milligram arm, which happened, and there were no safety concerns in any of those three meetings. I think we have a fourth one coming up in November of this year.
Just looking at the endpoint, the primary endpoint is really looking at the efficacy as well as the safety of leronlimab in combination with the current standard of care, which is LONSURF and Avastin, we also call the backbone, for third-line patients with colorectal cancer. We are looking at a number of secondary and exploratory endpoints. Again, we will look at safety and tolerability of leronlimab in combination with the current standard of care, backbone, again, as I call it. We are looking at changes in circulating tumor DNA. I think this is really important because we really took an adaptive approach around designing this study such that we can add things as necessary that become more prominent. And ctDNA is one of those things that we added.
We are going to really, I think, reap the benefits from that on a go-forward basis, and I will talk about that in a little bit. We are looking at ORR as well as, you can see, partial responses, stable disease, progression-free survival. So really, really important to look at those secondary endpoints and prove the efficacy of leronlimab in this patient population. So what is ctDNA? It really refers to DNA fragments from cancer cells that are released into the bloodstream. It is called a liquid biopsy. It is certainly much less invasive, it is faster, and it is more precise. We have heard it is really a game changer in cancer treatments. It replaces the painful biopsies in some cases. You can catch cancer earlier. It helps in really personalized medicine and choosing the best medicine. Checking to see if the treatment is working. You can see if the ctDNA is declining, if it is increasing.
In general, physicians have that ability to change medicines if necessary and spotting cancer relapses. Just in general, ctDNA is really, really important for oncology treatment on a go-forward basis. Then working with Natera, we are so pleased to be working with them in collaboration. We signed the collaboration late May of 2026, and they have just been a real pleasure to work with. They are really the recognized leader in ctDNA treatments. Just an overview of the collaboration that we have with Natera. As I mentioned, they are the global leader. One of the things that is really going to pay benefits, we believe, is kind of that last bullet on the bottom. In partnership with Natera, they have a very large database of 144,000 colorectal cancer patients, and within that, there is a subset of patients who they have ctDNA data around just the backbone bevacizumab and LONSURF.
We are going to be able to exploit that data to see what the real-world data is around the backbone of bevacizumab and LONSURF or Avastin and LONSURF to understand what the contribution of component is for leronlimab on top of that. We will be talking about that in the coming months about what that looks like relative to adding on leronlimab on top of it. You will see some data, what we are seeing out of our clinical study right now that is really quite impressive in terms of ctDNA declines, really after just 2 weeks. Actually, there it is. What we are seeing after just 2 weeks within our study, this is an N of 28 patients, so this is the most current data we have in our database through the Signatera exome, a median decrease of 86% after just as little as 2 weeks.
We view that as quite impressive. We look forward to correlating to clinical outcomes, both doses performing at maybe a dose response, and we will be interested in seeing how much decline in ctDNA equates to the clinical outcomes. Really, really interesting. Then the next slide actually shows on a 350 milligram versus 700 milligram, we are seeing decreases of 90% at the higher dose versus 80% at the 350 milligram dose. Both doses are performing extremely well, and it will be really interesting to see the, again, kind of the therapeutic window for this where it is helpful to patients. Just looking at a case study, Dr. Khasi is with City of Hope. He is the primary principal investigator in CLOVER. Well-credentialed individual.
I was actually at AACR and sat next to him at a poster presentation, and lots of folks came up to him because he really was on the forefront of instituting ctDNA as a standard of care, actually, for his patients. With that, we have a case study. This is patient 103001. You can see the significant decline in ctDNA over this patient, as much as 97% after as little as 8 weeks in testing. That really corresponds to what we saw liver scans for this individual. You can see the before and after with your own eye that the tumors are shrinking. You can see actually tumor volume on the box at the bottom left there is down 21%. That is important because at 30%, you do get a partial response, which is important for data in terms of the drug performing.
That’s certainly well on its way. Just looking at a lung scan at 8 weeks as well, you can see the before and after there, that again, all moving in the right directions in terms of tumor shrinkage. Just looking at the current backbone of bevacizumab and LONSURF, Avastin. Avastin was approved in August of 2023, by adding the two together, which again, is the current standard of care. Looking at the SUNLIGHT study, which is what bevacizumab and LONSURF were studied in, the overall response rate was 6.1%. No complete responders, and you can see other data there. We believe that this is certainly a beatable number, given the poor. This is an unmet medical need in particular, is what I’ll say. There was subsequent meta-analysis done with real world data, and the overall response rate was closer to 2.7%.
It’s really important to look at both of these. We believe early readouts that we’re seeing were very optimistic that we can beat this data. In fact, one of our primary endpoints is an overall response rate of 10% greater than the 6.1%. Again, given the early readouts we’re seeing, we’re very optimistic that we can beat that. I think that’ll be very helpful in discussions we have with the FDA, as well as potential partners about the benefits of leronlimab as a third line treatment of colorectal cancer patients. We put together this slide, and it’s really the baseline characteristics of CLOVER relative to the SUNLIGHT study. In the similar patient population age profile, comparable prevalence of liver metastasis in CLOVER, greater representation of rectal cancer in CLOVER. I don’t think anything to worry about there.
The really interesting thing that came out of this is the patient population that we’re studying, it’s more heavily pretreated population in our CLOVER study. We highlighted there, put around the red box there, 52% of our patients had greater than 3 lines of therapy, versus 13% for the SUNLIGHT study. In fact, what’s not on this slide is 26 patients in the SUNLIGHT study were actually only had one prior line of therapy. A much healthier patient population that SUNLIGHT studied versus our study. I think where that’s important, we talked about overall response rate of 6.1% in a healthier population. We’re studying a much sicker population, I’ll call it, and we believe that we can beat that 6.1% by greater than that 16.1% that I highlighted.
I think that’s going to go a long way to understand the benefits of this drug, again, in a much sicker population. Really excited about the benefits there. I mentioned the upcoming conferences. We’re very much looking forward to being at ESMO, and that is in October. We’ll look at additional clinical as well as ctDNA findings. Then we have in January of 2027 in San Francisco, further updates on clinical and biomarker outcomes, and then additional perspective on durability and consistency. We’re very much looking forward to additional real-world comparison data. I mentioned the Natera, and that really continued analysis around that. I think that’s going to be really powerful data that, again, will help us with the FDA as well as potential partners on a go-forward basis. Just looking at the clinical plan we have with CLOVER.
We did file an amendment which is currently being rolled out across the clinical sites. That is an extension for stable patients, as well as a rollover arm for salvage therapy for patients with documented progression. That will be a combination of leronlimab with pembrolizumab, a checkpoint inhibitor. We expect to have 2 patients dosed on that salvage arm component probably within the next couple of weeks. We are really excited to understand that component of adding a checkpoint inhibitor in that regard. Stay tuned in that regard. We are looking forward to the CHAMP study being started. That will be a phase I study. I think the take-home message there is it is for colorectal cancer patients in earlier lines of treatment. We are very much looking forward to seeing what that data looks like.
We are looking at other components of colorectal cancer, be it different lines, and so we will talk about that a little bit later as well. Let us just take a quick browse through what we have in triple-negative breast cancer. This is all retrospective data, and so what we have seen, very strong preclinical data. We saw a significant reduction in CTCs as well as upregulation of PD-L1. The clinical outcome is really the take-home message. 5 out of 5 patients who upregulated their PD-L1 and received a checkpoint inhibitor are alive after 5+ years. In fact, I believe in November, that will be 6 years that these patients are alive. Given the current outcome for triple-negative breast cancer, it is typically around 1 year. This is really, really compelling data. Then 3 out of 5 report no evidence of disease at this point in time. It is really interesting.
The flip side of that is 23 out of 23 patients who did not upregulate or not take a checkpoint inhibitor have passed away at this one time. Just looking at the baseline, you can see, again, the take-home message here is that the prior therapies, that these patients were very sick patients that we went into. Again, that speaks to, A, the safety data of leronlimab, but as well as helping out these patients who have really no other where to turn to. To get 5 out of 5 patients who upregulated their PD-L1 after taking leronlimab and then took a checkpoint inhibitor, we really view that prime and pair component as something very, very valuable that we are going to look to interrogate in future clinical trials in triple-negative breast cancer.
This is just a snapshot of what I just mentioned, looking at the upregulation of PD-L1, and that second rectangle there shows the 5 out of 5 patients who are alive today after, again, nearly almost 6 years. Just looking at the clinical plan for TNBC, we are interested in working with the PRE-I-SPY, which is the son or daughter of I-SPY, and we are looking at a dose escalation study as well as a contribution of component study. Then we are also looking at a neoadjuvant study in patients with HER2-negative breast cancer. Just looking at clinical priorities and upcoming milestones. We are going to look. I will try to get through these quickly so I have a little bit of time for Q&A. We are looking at confirming the standalone benefit of leronlimab plus the backbone. That is exactly what the colorectal cancer study is doing currently.
We heard that loud and clear from potential partners, giving us that feedback. Prospectively demonstrate induction of PD-L1. We’re looking at it as well. The benefit of adding ICI to leronlimab, I just mentioned that, in PD-L1 in these patients. Looking at the optimal dose as well. Just a quick look at the recent upcoming milestones. We have closed on a couple financings. I believe that’ll be very helpful in potential partnering, where we have enough money to sit across the table and not worry about running out of money. I think that’s really extremely important when you get to negotiations. We’re looking at the initiation of the City of Hope CHAMP study that it looks like third quarter calendar 2026. It could bleed in a little bit into the fourth quarter, but it’s very close to starting that study.
We’re really excited about that. I mentioned ESMO, initiation of dose study in triple-negative breast cancer in the fourth quarter. I mentioned ASCO as well, additional studies in colorectal cancer. We’re very much looking forward to discussing the data with the FDA. Be it that whether we ask for a breakthrough therapy, fast track designation, or some accelerated pathway, we’re very interested in putting that data package together in the second half of 2026. We think that’ll be very helpful for potential partnering as well. We’re very much looking at ASCO GI as really a comprehensive look at our data at that point. We’re being very active at talking to strategic partners. I will be at BIO-Europe in November. That’s a great partnering conference that we’re already setting up meetings in that regard.
Very much looking forward to talking to potential partners about the really interesting data we’re seeing thus far. Just a quick talk about this. I sat in on an AACR presentation, and there was about 10 pharmaceutical companies that presented. Here’s the kind of things that they communicated very particularly. Obvious target modulation, simple assessment, and targeting early stage of disease, first-in-class approach. We believe we check the boxes on that. In particular, safety is important, the age of the target market. We’re hitting as well, in particular for colorectal cancer, because colorectal cancer is now the leading cause of death in cancer patients under the age of 50. It’s a growing market, sadly. We are looking at a target market in that way as well. ctDNA in the news, it’s beginning more and more well accepted.
You can see the first FDA approval in ctDNA guided therapy occurred in May of 2025. Natera was mentioned in the first paragraph in that press release, more recently, there was another guided therapy as well, approved. Again, I’ll move through these quickly. Colorectal cancer is a very large market opportunity. It has a potential to grow to $25 billion in 2030. In particular, LONSURF, which its only indication approval is, sales were recognized to be $700 million in 2025, and it’s growing at a clip of 6.2% in 2026 already. Just some key takeaways. We have a novel approach to immuno-oncology. We have a very well-tolerated safety profile. I mentioned over 1,700 or approximately 1,700 patients. We have a very nice strategic collaboration in place with Natera.
The ctDNA data that we get from them is just really going to pay huge dividends for us, not only from the FDA, but from the potential partnering that we’re moving forward with. We have some very large market opportunities that I just mentioned. Then we have the potential to move into other solid tumor indications. We’re in discussions with institutions, world recognized institutions about other potential indications, including pancreatic cancer. With that, I think I left a few minutes for questions. Looking at It says, "What is the best way to learn more about the company and its clinical trials?" We have a lot of information on our website, including some very nice videos, that you can learn about the company. We’ve done a good job in keeping those updated. There are ways to look at presentations on there as well.
clinicaltrials.gov has all of our clinical trials on it. I’m just trying to read these. Sorry, they’re flipping by quick here. Let’s see here. Why doesn’t some patients need What do you think the current market perception is as it relates to CytoDyn, and what are the I think the perception of CytoDyn currently is that we have a very valuable drug candidate that works independently, or we’re getting a great growing body of evidence that leronlimab works independently to help cancer patients, in particular colorectal cancer patients. Then we have a very nice story about our prime and pair that allows the upregulation of PD-L1 such that it unlocks a number of patients that are otherwise ineligible to take a checkpoint inhibitor such as KEYTRUDA. So that’s a very attractive proposition for potential partners.
The combination of a drug candidate that works alone as well as in combination with their existing therapy. I think as we continue to grow this story, then we layer in ctDNA, which is a great predictor of how the drug is going to work and the corresponding scans that we see in the future, I think, it’s really going to help, again, grow the story not only with the FDA but with potential partners. I believe I’m out of time. Feel free to reach out to me. You can see my email address. If not, it’s rhoffman@cytodyn.com. I’m happy to answer any questions. I very much appreciate everyone’s support, and I’m very much looking forward to helping these underserved patients, in colorectal cancer in particular, which is our lead program. Very happy to be pleased at this conference, and I’m looking forward to presenting at more conferences.
Thank you very much.
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Moderator: Hello, and welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you have joined us. The next presentation of the day is from CytoDyn. Please note you may submit questions for the presenter at any time. You can also view a company’s availability for one-on-one meetings by clicking "Book a Meeting." At this point, I am very pleased to welcome Robert Hoffman, Chief Financial Officer of CytoDyn, which trades on the OTCQB Venture Market under the symbol CYDY. Welcome, Robert.
Robert Hoffman, Chief Financial Officer, CytoDyn: Thank you, Lily. I’m excited to present at the Life Science Virtual Investor Forum. Before I begin, I’d like to point out that I’ll be making numerous forward-looking statements during this presentation. Actual results may differ. Please refer to our risk factors on file with the SEC. As background, CytoDyn is a clinical stage oncology company. We’re advancing our molecule, leronlimab. It is a first-in-class humanized monoclonal antibody. We do target the CCR5 receptor with therapeutic potential across multiple indications. Our lead program is in metastatic colorectal cancer. We also have a program in breast cancer, and we’re looking at other solid tumor indications. Just taking a step back, we really try to keep integrity, responsibility, and service in everything that we do at CytoDyn. I like to say that we keep the activities we do with the patient as the center of everything we do.
Just thinking about designing clinical trials, start my timer. Designing clinical trials, we try to design the best study for patients to get the best outcome. I believe that also creates shareholder value, because we’re doing it in the best way possible. It helps the FDA, and it also helps potential partners to get the best data that we can out of any study that we do. In terms of our leadership, we have Dr. Jacob Lalezari, who’s been CEO since November of 2023. Lots of clinical experience with leronlimab, which comes in incredible helpfulness when we’re looking at clinical trials and other indication. Myself, I’ve been CFO for a little over a year now. Prior experience includes about 17 years at Arena Pharmaceuticals, which ultimately got acquired by Pfizer, and I sit on a couple outside boards, including FibroBiologics, as well as Tahoe Therapeutics.
Just a quick look at an executive summary. As I mentioned, leronlimab is a novel drug candidate. We have multiple demonstrated mechanisms of actions. We’re looking at some very large market opportunities for us across colorectal cancer. You’ll see a slide on that in a little bit. Triple-negative breast cancer, as well as other solid tumor indications would include pancreatic cancer, for example. One of the hallmarks of leronlimab is it’s a very well-tolerated drug candidate. We have extensive database of safety, including approximately now we updated this to 1,700 patients, enrolled across 20 plus different clinical sites. So that’s really something I think differentiates our drug candidate from a lot of other drug candidates in terms of the safety profile that we have, especially in cancer patients who are ill to begin with. Being able to check off that safety component is really, really helpful.
We do have very strong retrospective clinical data in triple-negative breast cancer. I will talk about that in a little bit. Then we have our early readouts from our CLOVER study in metastatic colorectal cancer. Then some multiple near-term milestones, including confirming the safety and durability efficacy readouts from our phase II CLOVER study. A presentation at ESMO. I will talk about that in a little bit, as well as a presentation at ASCO GI in January of 2027. Now let us turn to our colorectal cancer and CLOVER study, in particular. We are looking to confirm the-- before I get into that, actually to the next slide. The study really enrolled extremely quickly. You can see the first patient was dosed in June of 2025. We completed enrollment in April of 2026, less than one year.
We heard from our CRO that this was a really fast-moving enrollment that they have seen, in particular. I attribute that to, we heard back from a lot of the physicians treating these patients that after just a couple weeks, that it is more anecdotal, but they felt better. These patients felt better, and then the physicians also told us that they were prescribing a lot less pain medications. That really goes to show that word got around, and these clinics actually started enrolling patients much quicker than we had anticipated for sure. The Data Safety Monitoring Board has met three times now. First meeting there was to open up the 700 milligram arm, which happened, and there were no safety concerns in any of those three meetings. I think we have a fourth one coming up in November of this year.
Just looking at the endpoint, the primary endpoint is really looking at the efficacy as well as the safety of leronlimab in combination with the current standard of care, which is LONSURF and Avastin, we also call the backbone, for third-line patients with colorectal cancer. We are looking at a number of secondary and exploratory endpoints. Again, we will look at safety and tolerability of leronlimab in combination with the current standard of care, backbone, again, as I call it. We are looking at changes in circulating tumor DNA. I think this is really important because we really took an adaptive approach around designing this study such that we can add things as necessary that become more prominent. And ctDNA is one of those things that we added.
We are going to really, I think, reap the benefits from that on a go-forward basis, and I will talk about that in a little bit. We are looking at ORR as well as, you can see, partial responses, stable disease, progression-free survival. So really, really important to look at those secondary endpoints and prove the efficacy of leronlimab in this patient population. So what is ctDNA? It really refers to DNA fragments from cancer cells that are released into the bloodstream. It is called a liquid biopsy. It is certainly much less invasive, it is faster, and it is more precise. We have heard it is really a game changer in cancer treatments. It replaces the painful biopsies in some cases. You can catch cancer earlier. It helps in really personalized medicine and choosing the best medicine. Checking to see if the treatment is working. You can see if the ctDNA is declining, if it is increasing.
In general, physicians have that ability to change medicines if necessary and spotting cancer relapses. Just in general, ctDNA is really, really important for oncology treatment on a go-forward basis. Then working with Natera, we are so pleased to be working with them in collaboration. We signed the collaboration late May of 2026, and they have just been a real pleasure to work with. They are really the recognized leader in ctDNA treatments. Just an overview of the collaboration that we have with Natera. As I mentioned, they are the global leader. One of the things that is really going to pay benefits, we believe, is kind of that last bullet on the bottom. In partnership with Natera, they have a very large database of 144,000 colorectal cancer patients, and within that, there is a subset of patients who they have ctDNA data around just the backbone bevacizumab and LONSURF.
We are going to be able to exploit that data to see what the real-world data is around the backbone of bevacizumab and LONSURF or Avastin and LONSURF to understand what the contribution of component is for leronlimab on top of that. We will be talking about that in the coming months about what that looks like relative to adding on leronlimab on top of it. You will see some data, what we are seeing out of our clinical study right now that is really quite impressive in terms of ctDNA declines, really after just 2 weeks. Actually, there it is. What we are seeing after just 2 weeks within our study, this is an N of 28 patients, so this is the most current data we have in our database through the Signatera exome, a median decrease of 86% after just as little as 2 weeks.
We view that as quite impressive. We look forward to correlating to clinical outcomes, both doses performing at maybe a dose response, and we will be interested in seeing how much decline in ctDNA equates to the clinical outcomes. Really, really interesting. Then the next slide actually shows on a 350 milligram versus 700 milligram, we are seeing decreases of 90% at the higher dose versus 80% at the 350 milligram dose. Both doses are performing extremely well, and it will be really interesting to see the, again, kind of the therapeutic window for this where it is helpful to patients. Just looking at a case study, Dr. Khasi is with City of Hope. He is the primary principal investigator in CLOVER. Well-credentialed individual.
I was actually at AACR and sat next to him at a poster presentation, and lots of folks came up to him because he really was on the forefront of instituting ctDNA as a standard of care, actually, for his patients. With that, we have a case study. This is patient 103001. You can see the significant decline in ctDNA over this patient, as much as 97% after as little as 8 weeks in testing. That really corresponds to what we saw liver scans for this individual. You can see the before and after with your own eye that the tumors are shrinking. You can see actually tumor volume on the box at the bottom left there is down 21%. That is important because at 30%, you do get a partial response, which is important for data in terms of the drug performing.
That’s certainly well on its way. Just looking at a lung scan at 8 weeks as well, you can see the before and after there, that again, all moving in the right directions in terms of tumor shrinkage. Just looking at the current backbone of bevacizumab and LONSURF, Avastin. Avastin was approved in August of 2023, by adding the two together, which again, is the current standard of care. Looking at the SUNLIGHT study, which is what bevacizumab and LONSURF were studied in, the overall response rate was 6.1%. No complete responders, and you can see other data there. We believe that this is certainly a beatable number, given the poor. This is an unmet medical need in particular, is what I’ll say. There was subsequent meta-analysis done with real world data, and the overall response rate was closer to 2.7%.
It’s really important to look at both of these. We believe early readouts that we’re seeing were very optimistic that we can beat this data. In fact, one of our primary endpoints is an overall response rate of 10% greater than the 6.1%. Again, given the early readouts we’re seeing, we’re very optimistic that we can beat that. I think that’ll be very helpful in discussions we have with the FDA, as well as potential partners about the benefits of leronlimab as a third line treatment of colorectal cancer patients. We put together this slide, and it’s really the baseline characteristics of CLOVER relative to the SUNLIGHT study. In the similar patient population age profile, comparable prevalence of liver metastasis in CLOVER, greater representation of rectal cancer in CLOVER. I don’t think anything to worry about there.
The really interesting thing that came out of this is the patient population that we’re studying, it’s more heavily pretreated population in our CLOVER study. We highlighted there, put around the red box there, 52% of our patients had greater than 3 lines of therapy, versus 13% for the SUNLIGHT study. In fact, what’s not on this slide is 26 patients in the SUNLIGHT study were actually only had one prior line of therapy. A much healthier patient population that SUNLIGHT studied versus our study. I think where that’s important, we talked about overall response rate of 6.1% in a healthier population. We’re studying a much sicker population, I’ll call it, and we believe that we can beat that 6.1% by greater than that 16.1% that I highlighted.
I think that’s going to go a long way to understand the benefits of this drug, again, in a much sicker population. Really excited about the benefits there. I mentioned the upcoming conferences. We’re very much looking forward to being at ESMO, and that is in October. We’ll look at additional clinical as well as ctDNA findings. Then we have in January of 2027 in San Francisco, further updates on clinical and biomarker outcomes, and then additional perspective on durability and consistency. We’re very much looking forward to additional real-world comparison data. I mentioned the Natera, and that really continued analysis around that. I think that’s going to be really powerful data that, again, will help us with the FDA as well as potential partners on a go-forward basis. Just looking at the clinical plan we have with CLOVER.
We did file an amendment which is currently being rolled out across the clinical sites. That is an extension for stable patients, as well as a rollover arm for salvage therapy for patients with documented progression. That will be a combination of leronlimab with pembrolizumab, a checkpoint inhibitor. We expect to have 2 patients dosed on that salvage arm component probably within the next couple of weeks. We are really excited to understand that component of adding a checkpoint inhibitor in that regard. Stay tuned in that regard. We are looking forward to the CHAMP study being started. That will be a phase I study. I think the take-home message there is it is for colorectal cancer patients in earlier lines of treatment. We are very much looking forward to seeing what that data looks like.
We are looking at other components of colorectal cancer, be it different lines, and so we will talk about that a little bit later as well. Let us just take a quick browse through what we have in triple-negative breast cancer. This is all retrospective data, and so what we have seen, very strong preclinical data. We saw a significant reduction in CTCs as well as upregulation of PD-L1. The clinical outcome is really the take-home message. 5 out of 5 patients who upregulated their PD-L1 and received a checkpoint inhibitor are alive after 5+ years. In fact, I believe in November, that will be 6 years that these patients are alive. Given the current outcome for triple-negative breast cancer, it is typically around 1 year. This is really, really compelling data. Then 3 out of 5 report no evidence of disease at this point in time. It is really interesting.
The flip side of that is 23 out of 23 patients who did not upregulate or not take a checkpoint inhibitor have passed away at this one time. Just looking at the baseline, you can see, again, the take-home message here is that the prior therapies, that these patients were very sick patients that we went into. Again, that speaks to, A, the safety data of leronlimab, but as well as helping out these patients who have really no other where to turn to. To get 5 out of 5 patients who upregulated their PD-L1 after taking leronlimab and then took a checkpoint inhibitor, we really view that prime and pair component as something very, very valuable that we are going to look to interrogate in future clinical trials in triple-negative breast cancer.
This is just a snapshot of what I just mentioned, looking at the upregulation of PD-L1, and that second rectangle there shows the 5 out of 5 patients who are alive today after, again, nearly almost 6 years. Just looking at the clinical plan for TNBC, we are interested in working with the PRE-I-SPY, which is the son or daughter of I-SPY, and we are looking at a dose escalation study as well as a contribution of component study. Then we are also looking at a neoadjuvant study in patients with HER2-negative breast cancer. Just looking at clinical priorities and upcoming milestones. We are going to look. I will try to get through these quickly so I have a little bit of time for Q&A. We are looking at confirming the standalone benefit of leronlimab plus the backbone. That is exactly what the colorectal cancer study is doing currently.
We heard that loud and clear from potential partners, giving us that feedback. Prospectively demonstrate induction of PD-L1. We’re looking at it as well. The benefit of adding ICI to leronlimab, I just mentioned that, in PD-L1 in these patients. Looking at the optimal dose as well. Just a quick look at the recent upcoming milestones. We have closed on a couple financings. I believe that’ll be very helpful in potential partnering, where we have enough money to sit across the table and not worry about running out of money. I think that’s really extremely important when you get to negotiations. We’re looking at the initiation of the City of Hope CHAMP study that it looks like third quarter calendar 2026. It could bleed in a little bit into the fourth quarter, but it’s very close to starting that study.
We’re really excited about that. I mentioned ESMO, initiation of dose study in triple-negative breast cancer in the fourth quarter. I mentioned ASCO as well, additional studies in colorectal cancer. We’re very much looking forward to discussing the data with the FDA. Be it that whether we ask for a breakthrough therapy, fast track designation, or some accelerated pathway, we’re very interested in putting that data package together in the second half of 2026. We think that’ll be very helpful for potential partnering as well. We’re very much looking at ASCO GI as really a comprehensive look at our data at that point. We’re being very active at talking to strategic partners. I will be at BIO-Europe in November. That’s a great partnering conference that we’re already setting up meetings in that regard.
Very much looking forward to talking to potential partners about the really interesting data we’re seeing thus far. Just a quick talk about this. I sat in on an AACR presentation, and there was about 10 pharmaceutical companies that presented. Here’s the kind of things that they communicated very particularly. Obvious target modulation, simple assessment, and targeting early stage of disease, first-in-class approach. We believe we check the boxes on that. In particular, safety is important, the age of the target market. We’re hitting as well, in particular for colorectal cancer, because colorectal cancer is now the leading cause of death in cancer patients under the age of 50. It’s a growing market, sadly. We are looking at a target market in that way as well. ctDNA in the news, it’s beginning more and more well accepted.
You can see the first FDA approval in ctDNA guided therapy occurred in May of 2025. Natera was mentioned in the first paragraph in that press release, more recently, there was another guided therapy as well, approved. Again, I’ll move through these quickly. Colorectal cancer is a very large market opportunity. It has a potential to grow to $25 billion in 2030. In particular, LONSURF, which its only indication approval is, sales were recognized to be $700 million in 2025, and it’s growing at a clip of 6.2% in 2026 already. Just some key takeaways. We have a novel approach to immuno-oncology. We have a very well-tolerated safety profile. I mentioned over 1,700 or approximately 1,700 patients. We have a very nice strategic collaboration in place with Natera.
The ctDNA data that we get from them is just really going to pay huge dividends for us, not only from the FDA, but from the potential partnering that we’re moving forward with. We have some very large market opportunities that I just mentioned. Then we have the potential to move into other solid tumor indications. We’re in discussions with institutions, world recognized institutions about other potential indications, including pancreatic cancer. With that, I think I left a few minutes for questions. Looking at It says, "What is the best way to learn more about the company and its clinical trials?" We have a lot of information on our website, including some very nice videos, that you can learn about the company. We’ve done a good job in keeping those updated. There are ways to look at presentations on there as well.
clinicaltrials.gov has all of our clinical trials on it. I’m just trying to read these. Sorry, they’re flipping by quick here. Let’s see here. Why doesn’t some patients need What do you think the current market perception is as it relates to CytoDyn, and what are the I think the perception of CytoDyn currently is that we have a very valuable drug candidate that works independently, or we’re getting a great growing body of evidence that leronlimab works independently to help cancer patients, in particular colorectal cancer patients. Then we have a very nice story about our prime and pair that allows the upregulation of PD-L1 such that it unlocks a number of patients that are otherwise ineligible to take a checkpoint inhibitor such as KEYTRUDA. So that’s a very attractive proposition for potential partners.
The combination of a drug candidate that works alone as well as in combination with their existing therapy. I think as we continue to grow this story, then we layer in ctDNA, which is a great predictor of how the drug is going to work and the corresponding scans that we see in the future, I think, it’s really going to help, again, grow the story not only with the FDA but with potential partners. I believe I’m out of time. Feel free to reach out to me. You can see my email address. If not, it’s rhoffman@cytodyn.com. I’m happy to answer any questions. I very much appreciate everyone’s support, and I’m very much looking forward to helping these underserved patients, in colorectal cancer in particular, which is our lead program. Very happy to be pleased at this conference, and I’m looking forward to presenting at more conferences.
Thank you very much.
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My comments are just my opinions and should NOT be taken as investment advice.
