Thank you so much for being with us here today. I am excited to introduce to you Robert Hoffman, the CFO of CytoDyn.
Thank you. Thank you. Really excited to be here today to tell you what we have going on at CytoDyn. We have a really jam-packed year of upcoming milestones. Before I do, I'd like to point out that I will be making numerous forward-looking statements during this presentation. Actual results may differ. Please review our risk factors on file with the SEC. CytoDyn, if you know anything about us, we're a clinical- stage oncology company. We're currently in phase II in colorectal cancer. We're advancing leronlimab, which is our monoclonal antibody, first-in-class humanized, targeting the CCR5 receptor, which is an important receptor in the body, with therapeutical potential across multiple indications. I mentioned colorectal cancer.
We have really interesting retrospective data in triple- negative breast cancer that we hope later in the year to start studies to prove that prospectively. Again, I'll go over colorectal cancer, which is currently in phase II, that we're seeing really interesting data out of as well. Just to take a step back, CytoDyn, we focus on the patient. We really are focused on doing the best clinical trial we can do to make sure that the outcome is helpful to patients, it's approval by the FDA. We put a lot of effort into designing the study. We believe if we focus on patients and doing the best study possible, that ultimately every stakeholder will benefit, including shareholders and other stakeholders. In that, there's integrity, responsibility, and service in that.
Just a quick snapshot on our leadership. Jacob Lalezari has been CEO since November of 2023. He's an MD by training and has lots of experience with leronlimab and previous clinical trials. Myself, I've been with the company about a year now. I joined the company, actually kinda came out of retirement. I saw the retrospective data, and I also saw the data around the safety profile, which for a cancer drug is just very safe and very tolerable. My prior experience includes 17 years at Arena Pharmaceuticals. I took the company public in 2000, raised $1.2 billion during my time period there. We had collaboration with Merck, J&J, and others.
Again, really excited about this and kinda came out of retirement to do my one last rodeo in order to really help patients, which I believe this is an excellent opportunity to do so. I also sit on a couple public company boards, including Esperion Therapeutics, which has just announced they're getting acquired, TuHURA Biosciences, which is a company that I was CEO most recently, and I merged that company with TuHURA, as well as FibroBiologics out of Houston, Texas. Just a quick executive summary. I mentioned leronlimab. It's a novel drug candidate, and there's multiple mechanisms of action that we have going on. We're really focused on large market opportunities. Colorectal cancer, you're seeing a little bit, is unfortunately a much growing cancer indication.
We're looking at triple- negative breast cancer and then other solid tumors, including potentially pancreatic, as well as glioblastoma and other potential indications. Solid tumors. I mentioned the safety profile. Again, this is what really brought me to the company. If you can get kinda safety out of the way, and it's never out of the way, just to be fair, but we have a really well-tolerated drug candidate that it's been tested in over 1,600 patients across 20+ clinical trials. Again, prospectively prove what we saw retrospectively. Really, I worry much less about the safety profile, which is kind of unusual and a nice circumstance to be in for a cancer indication. I mentioned the strong retrospective clinical data. It significantly increases overall survival rates.
I'll talk about that in a little bit in triple- negative breast cancer. We're looking to, you know, support that with readouts in calendar year 2026. As I mentioned, we have multiple near- term milestones this year. We wanna confirm the durability and safety and efficacy of the readouts in our phase II colorectal cancer study. That should be in the second quarter as well as the third quarter over the summer of this year. We're presenting at ESMO, the phase II updates in Madrid, Spain, in the fourth quarter. We're very much looking forward to a presentation at ASCO GI in San Francisco in the first quarter of 2027. Just taking a step back and looking at a very important receptor in the body, CCR5.
It has an established role in cancer and related therapeutics. It plays a role in migration invasion of cells in the bloodstream. Again, really important and if you can block that or be an antagonist to that receptor, and especially on the T cells, it turns on these anti-tumor activities that really restore the immune function. What we saw too, and you'll see that in a little bit, is we increased PD-L1 levels and it unlocks a lot of patients to take a PD-1 drug, such as KEYTRUDA, for example. Again, a really important receptor within the body that we're targeting. Just the obligatory snapshot of our pipeline. You can see I mentioned colorectal cancer.
We just finished enrollment of that 60-patient study last month. We enrolled it much quicker than what we had anticipated, which I think is a strong indication that physicians, and you'll see in a little bit, physicians are seeing that it's third line or later that patients are feeling better early on, and so they thought it was an opportunity for these patients who really have little or no alternatives to enroll in this study. I mentioned triple-negative breast cancer, which we're looking later in the year to start another study there, and then some earlier stuff in glioblastoma and prostate cancer. Just the key takeaways. Yeah, again, CCR5 is an important receptor within the body.
We're looking at colorectal cancer, triple-negative breast cancer, as well as prostate cancer, and those have high CCR5 expressions. This is a study that we did or a study we had done. We looked at other indications with high CCR5 expression and low PD-L1 expression. I mentioned leronlimab can What we've seen is it can increase PD-L1 expression. What came out of that is colorectal cancer, again, which we're studying, pancreatic cancer, as well as prostate cancer. I mentioned colorectal cancer, and this is sad. This came out in January. What we're seeing now, it's now the leading cause of a cancer death in the U.S. in people under the age of 50. You know, there's been some theories or thoughts about whether it's diet or other things, environment or whatnot.
It's just a sad statement, and it continues to increase year-over-year at a rate of about 1.1%. You can see, even younger ages that, it's increasing at a higher rate, so really troubling statistics related to colorectal cancer. As a result, it's a large market opportunity. It has the potential to exceed $25 billion by 2030 globally. So you can see the incidence rates as well as the, you know, potential revenue gain growing beyond $25 billion in 2030. Triple-negative breast cancer has a large market opportunity for us as well, exceeding $7 billion in 2030.
There's really no good standard of care in triple-negative breast cancer, so we can find something that works, and we believe that we have an excellent opportunity to do that. Prove prospectively what we saw retrospectively, and I'll go over that data in a little bit. That market is over $7 billion into 2030 projected. Large market opportunities for us. I mentioned the profile, which gives me a lot of confidence that we now just have to prove efficacy. I mentioned that strong retrospective data, which you'll see in a little bit, and the market opportunities. We're looking at other indications, including glioblastoma. We have a institution that's looking to run an investigator-initiated study in glioblastoma as well as pancreatic cancer.
We have a very well-known prominent institution looking at pancreatic cancer for us, that we hope to announce later this year and some other solid tumor indications. Let's take a deeper dive into our colorectal cancer study program. We currently have the ongoing study, which is CLOVER. That is a phase II study, 60-patient study. It's open label. We randomized patients into the 350 dose group initially as well as the 700 dose group, dosage group. We're looking at third line or later, MSS, colorectal cancer patients. The lead investigator, who's really important in this, and you'll see his data in a little bit, is Dr. Pashtoon Kasi, MD out of City of Hope.
Really, really interesting data that he's seen, and he's been the highest enroller of our study because he really believes in circulating tumor DNA results, and you'll see that in a little bit as well. We completed the target enrollment. We had two data safety monitoring board meetings in late last year as well as March of 2026. There were no safety concerns. We, at the December 2025 one, opened up the study for the higher dose, which we're really excited about to get patients into the higher dose group. A lot of the data you see is around the 350.
We believe that data is quite good from what we're seeing now, so we're even more excited to get patients further along who started later in the study on the higher dose group to get to their readouts at later in the study, which will be later this summer. Really interesting. 100% of the patients screened were actually tested as CCR5 positive. Very well-tolerated, which we were hopeful, and then we did see it. There were no Grade 3 or 4 adverse events, no serious adverse events related to leronlimab. Again, that's nice to check that box. We'll continue to check that box because we'll continue to monitor the safety as we go through the study. Really interesting there and this is a poster that Dr. Kasi presented at City of Hope.
We saw really early ctDNA declines in the first 19 patients enrolled at City of Hope. 100% of patients showed declines in ctDNA, the median decrease after just two weeks was 70% at week two. That, you know, ctDNA is a really good biomarker, which prognosticates the, you know, additional metastasis in cancer as well as a predictor of how your drug is performing within the body. You just gotta, you know Again, we're really pleased with this, now we gotta see that that correlates to overall survival as well as progression-free survival. You can see the early scans, you'll see two scans in my presentation. The early scans do correlate with what we're seeing in the ctDNA decreases.
We're also seeing a numeric increase in the PD-L1 levels observed in a majority of patients. Again, that's important because if you look at a drug like KEYTRUDA, for example, one of the things on the label is you have to have a certain PD-L1 level. If you're below that, it's not indicated for that. What we saw retrospectively was that we raised PD-L1 levels, and you can imagine if you raise it enough that you get within the range of taking KEYTRUDA, it unlocks a whole bunch of patients for the PD-1 drug, KEYTRUDA. There's about 10 or 11 approved PD-1 companies out there that it could just unlock a whole number of patients, depending on the indication.
As I mentioned, and I think this is why City of Hope really got a lot of patients into the study, is the principal investigator who I mentioned, Dr. Kasi, these are very sick patients. They were responding clinically, and they were actually telling him that they had less pain. These are folks that if they really don't go into our trial, they're probably headed to hospice. That's, it's really great to hear that at least characteristically, anecdotally, that they're feeling better. This, as I mentioned, Dr. Pashtoon Kasi, City of Hope, he did a presentation at AACR, which is in San Diego in April, and I'll show you what he saw. This is patient 103001, and you can see, this is a log scale.
At the highest, it's the second last, third last line, the circulating tumor DNA was about 130,000 parts per million of circulating tumor DNA. If you look, it got as low as almost 1,500 circulating tumor parts per DNA. That's a really good indicator, as I mentioned, for a prognostic as well as a predictive for the drug leronlimab, the drug candidate. Again, this is a 350 dose group. We're very much looking forward to additional data from 350 as well as the 700 dose group. These are the, again, early scans. This is a liver scan, patient 103001 again, and you can see the before and after.
This is after eight weeks of treatment or post-treatment. We're really excited about this, that the ctDNA is a good predictor for what's happening within the body, liver is one of the most difficult organs within the body to fight metastatic cancer in that regard. Again, another scan here of the lung, you can see the before and after and the related tumors that are shrinking, again, just as little as 8 weeks of treatment. Looking at the current standard of care, it's, you know, an underserved area. The current standard of care is LONSURF and bevacizumab or Avastin, as the brand name is called. The overall response rate is 6.1%.
They saw no complete responders in the SUNLIGHT trial, excuse me. 246 patients, you know, good-sized trial. You can see the PFS as well as the overall survival is pretty dismal. If you look at a meta-analysis done around real- world data, you can see the overall response rate is actually even less than that. We are talking to a group that will supply us with real- world data, and it'll be really interesting to get that real- world data such that we can have data in our trials to compare additional real- world data relative to our study. We think that'll be really powerful.
Kind of stay tuned on that as we work through getting that, I'll call it a collaborator, in alignment, and we'll move forward from there. As I mentioned, you know, just the clinical plan, it is a third line or later patients, so again, very sick patients. We are looking at, I'll call it an extension of the study. If a patient is on for a full year, we're looking at opening up an arm that they would go on a KEYTRUDA or other drug checkpoint inhibitor to test that in combination. Right now, we're very much focused on leronlimab as a monotherapy.
I will tell you, I'm jumping ahead a little bit, but we have been meeting with potential collaborators along the way, and really a lot of it's just education. I joined, like I said, in May of last year. I was at BIO-Europe in November, met with a couple potential collaborators. We're at BIO later this next month, actually. We're at ASCO later this year. One thing that really resonated, and you'll see another slide of the other things that came through as well, Tyler and I, who's in the crowd here, went to AACR in April, where we presented the poster, and there was a partnering discussion, and they're really focused on monotherapy.
They like combination, but they also wanna see that your drug works independently, as well as in combination with their checkpoint inhibitor, for example. That really resonated, and that's very much what we're aiming to do. Again, I go back to the patient focus that we run the best study, and that's showing leronlimab works as a monotherapy, and then have this extension to show in combination with a checkpoint inhibitor, there's a patient derives benefit. Then we're also looking at a investigator-initiated study, with again, Dr. Kasi. This would be with CRC patients. It would actually be moving up the line in terms of treatment for patients, so less sick, hopefully.
It is jointly funded between us and City of Hope, and we're looking at tumor effects in liver . Again, very important, and again, one of the worst metastasis to treat. We're really excited to move that forward. Let's focus on the data that we saw. The time is going quicker than I thought. I gotta move through this a little quicker. Just the data that we saw in triple- negative breast cancer, what we saw was a 98% reduction metastasis regression in mice. We saw this retrospective data, I'll skip ahead a little bit. Five out of five patients who upregulated PD-L1 and received an immune checkpoint inhibitor are alive today after 5+ years.
Even more importantly, three of those five have currently no evidence of disease. Three of those five actually had metastasis in the lung and the brain. This is really, really important. Again, it's retrospective data. We're very much looking forward to proving this on a prospective basis. Unfortunately, 23 out of 23 patients out of the 28 patients who did not upregulate or take a PD-L1 or a checkpoint inhibitor are deceased today. This is just a study design of where the patients came from, the three different studies. This tells you that they were very sick patients that were in the study. You can see the number of different drugs that they were on or prior therapies. I don't know why that keeps doing that.
Just real quick, you can see, this reiterates what I just said that the five out of five in the, in the box, the second box or rectangle who took leronlimab for a 42-day treatment, are alive today after 5+ years who then took a checkpoint inhibitor. Just in summary, we're looking, let's go forward, actually. We're looking at a current standard of care, second-line or later in HER2 patients with breast cancer. Part 1 would be a dose escalation. I will, I guess, announce that we do have a commitment from a checkpoint inhibitor company to provide us with their drug. We view that as really positive. More on that, as we move forward, later in the year.
We did open up an Expanded Access Program for triple-negative breast cancer patients. That was internally funded by a high net worth individual who, as we characterize it, as an initial investment in that regard. We're looking at neoadjuvant in breast cancer patients. I'll skip over this. It's kind of what we said already. Just recent and upcoming milestones. We did close on the Expanded Access funding, as I mentioned. We did close earlier this year on an oversubscribed, I'll call it, $17.5 million financing for continued development of leronlimab. We did present initial ctDNA readouts in our colorectal cancer study at AACR. That was the poster that Dr. Kasi did. We did enroll our first patient in triple-negative breast cancer .
We do have a submission, we completed our submission to the FDA regarding the timing of the ICI for patients who are on the study for a year. We're looking at the City of Hope starting, that was the, in, I mentioned that on the previous slide. We're looking at a dose escalation study in triple- negative breast cancer. We're looking at presenting at ESMO, which I will be at in Madrid. We're looking at a presentation at ASCO GI. One thing that's not on here is, we have Weill Cornell Medicine, who is very interested in Alzheimer's disease in leronlimab. We've been talking about it for a while, so kinda stay tuned for the first patient dose in that regard.
Then this is just upcoming FDA and potential partnerships. We're looking at updated biomarkers at ESMO. We're looking at data to support a Fast Track designation as well as a Breakthrough Therapy designation. We will do everything we can to talk to the FDA about, depending on how good the data is with colorectal cancer, if there's a Fast Track designation to get the drug approved quicker. Then I continue to travel around the world with folks to look at potential partner opportunities. I mentioned last year, BIO-Europe . I mentioned this year we'll be at ASCO as well as BIO, later in the year, I'll be at other ones. I think that's what we got. I'm happy to open it up for 50 seconds to any questions you may have.
Okay, we're around all day today, so feel free to grab me. If not, I think my email address is on here as well. This will be on the website at some point, so feel free to reach out. Thank you so much.