Good morning. So happy to have you here with us. It is my pleasure to introduce to you Robert Hoffman, the CFO of CytoDyn .
Thank you. Very happy to be here at the Hotel del Coronado and presenting at the LD Micro Cap Conference. 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, so please review our risk factors on file with the FDA. We are a clinical stage oncology company advancing lorazumab, a first-in-class humanized monoclonal antibody, which is targeting a very important receptor, the CCR5 receptor, with therapeutic potential across multiple indications. We're right now focused on solid tumor indications, which include colorectal cancer, which we're in a phase two ongoing clinical trial currently, as well as triple-negative breast cancer, which I'll go through that data, which is really exciting data that we have on a retrospective data analysis, and we're looking forward to proving that prospectively.
I forgot I don't have a microphone hooked to my body here, so I'll keep close to the podium. We really focus on our mission, vision, and core values, which are integrity, responsibility, and service. Throughout everything we do, we integrate and weave this in to make sure that we're focused on patients, we're focused on oncology in this case, and treating patients which ultimately will create shareholder value in the long term. The next slide here is a picture of our leadership team. Dr. Lilazeri, who's an MD, has lots of experience in the clinic with lorazumab. He's an expert. Myself, Robert Hoffman, I joined earlier this year in May of 2025. Prior experience includes 17 years at Arena Pharmaceuticals. I took the company public, raised in excess of $1.2 billion while I was there.
They, after I left, got acquired by Pfizer, but I also sit on multiple boards currently, including Esperion Therapeutics, which is a commercial stage company, TuHURA Biosciences, which was a result of a merger where I was CEO at Kantara. I still sit on the board there in the fibrobiologic side of Texas. We also have a really great leadership team surrounding Jay and I, including Dr. Pastel, who is a world thought leader in CCR5 oncology. We're really pleased to have a great surrounding cast around both myself and Jay. Just an executive summary. As I mentioned, lorazumab is a novel drug candidate with a unique cold-to-hot mechanism of action. Really excited about that, and we'll talk a lot more about that during the presentation. We're looking at large market opportunities. I mentioned colorectal cancer as well as triple-negative breast cancer.
We have some additional market data that suggests other potential indications to go after. I think a hallmark of, I know a hallmark of lorazumab is the safety profile. It's been tested in over 1,600 patients, and it's very well tolerated. Excellent safety profile, which gives us a lot of confidence. We just have to focus on prospectively confirming the data we saw in our retrospective data. We're very comfortable with the safety profile. Again, near-term readouts supporting the MOA expected in early 2026 through our colorectal cancer study. I'll talk a little bit more about that in the future here. CCR5 is just in a really important key area. CytoDyn has turned its attention to oncology indications and solid tumor indications in particular at this time. CCR5 and the interplay with CCL5 ligand play an important role in the multiple processes that promote tumor progression.
Blocking CCR5 receptor on Tregs turns the anti-tumor fighting properties and restores immune function. Interestingly, chemotherapy actually has been linked to increased CCR5 expression. This would be an important area for lorazumab to reduce that CCR5 expression and therefore reduce the levels of metastasis during chemotherapy. Really, really important and interesting information. There we go. Let's try this. There we go. The take-home message here with this very busy slide is lorazumab blocks CCR5, disrupting tumor migration. Lorazumab blocks immunosuppressive cells, triggering PD-L1 upregulation. This primes the tumor, expanding access to ICI treatments, which otherwise the patients would not qualify for an ICI therapy. Really, really important. You think about Keytruda, for example. Triple-negative breast cancer, it's between 30%- 40%, I believe the latest information of triple-negative breast cancer patients are eligible for an ICI based upon their CPS scores.
If we can upregulate those other patients that are not otherwise eligible, all of a sudden it opens up a much larger market for patients to take an immunotherapy, which have been proved to be really effective in solid tumor oncology and other types of cancer as well. This is just a summary, and the number five is highlighted there in red. We induce PD-L1 expression, turning those cold tumors to hot, and again, make them more amenable to ICI therapies that are out there and currently on the market. This is a very busy slide, but this is more information that we have on the different types of solid tumors. You can see to the right there the different types of tumors.
This is the take-home message right here that the most prevalent CCR5 expression across indication are triple-negative breast cancer, which you know we're studying, metastatic colorectal cancer, which we're studying, and then prostate cancer shows up there as well. Indication with high CCR5 expression and low PD-L1 expression are metastatic colorectal cancer because there's a distinction between colorectal and metastatic, and we are testing metastatic colorectal cancer. Pancreatic cancer shows up there as well, as well as prostate cancer. This gives us, assuming we're successful in our other indications, additional indications to go after. We have a maturing pipeline. I mentioned colorectal cancer currently in a phase two. I'll go over that study in a minute. Triple-negative breast cancer, we are looking to get FDA approval on the phase two study design. We're looking at combination studies. We're also looking at glioblastoma.
We're looking at a potential investigator-initiated study, as well as prostate cancer, which is in the early stages. Just looking at the basics, again, it's a humanized monoclonal antibody, very well tolerated. We're looking at induction of PD-L1. We think that's really significant. Again, our studies are and will be designed to look at induction of PD-L1 data as the study goes along. We're looking at large market opportunities. I have a couple new slides on that as well that show the increase in the market globally for both colorectal as well as triple-negative breast cancer. We have potential expansion in other markets, as I mentioned. Let's go over the triple-negative breast cancer study. We do have retrospective data that we pulled together.
What we're seeing is survival rates in excess of 48 months after treatment with lorazumab that suggest a paradigm shift after they also got treatment with a checkpoint inhibitor. You can see the four-year survival rate is just under 18%. By the time we get to the San Antonio Breast Cancer meeting in December in San Antonio, we should have five-year data. Again, really, really outstanding data on a retrospective data. The take-home messages here: five out of five patients, or 100% of patients who upregulated PD-L1 and received lorazumab with any checkpoint inhibitor, are alive after four years. Three out of five are currently no evidence of disease. You can see down in the bottom right of the slide here that, on average, they failed a median of two prior lines of treatment. They're very sick patients, and we're really, really pleased with this data.
In fact, we had a Zoom call. It was right after I started, and to see a woman in particular who was very sick—she's one of the five here—be very vivacious and active, smiling, just, you know, it's why we're here to do the things that we do. It really, really profoundly affected me. You can see the significant upregulation of PD-L1 on circulating tumor cells. The upregulation there, really, really profound data. This is the new slide that we have on the TNBC market. Currently, what is it, 105,000 patients in 2024 alone, growing to about 108,000 in 2030. That equates to annual revenue on a global basis of $4.3 billion, growing to just around $7.5 billion in 2030. Very large market opportunities for us. I think I went over the advantages that we have. It's due to the unique mechanism.
You can see all of these actually enhance the anti-tumor immune response and drive PD-L1 increases. The same thing here, with inhibiting the CCR5 signaling and blocking the mediated recruitment of CCR5 in combination with the CCL5 ligand that produces upregulation of PD-L1. We've seen, again, everything here on the slides that I mentioned before elevates the PD-L1 expression, which again makes it amenable to taking an ICI for these patients in combination with lorazumab. Looking at the data, which gives us a lot of confidence to move forward, is preclinical data. We saw a 98% reduction in metastases and a regression in metastases of five of eight mice. You'll see a slide in a minute which shows pictorially that information. We also saw a reduction in the circulating tumor cells of 57% of patients, significant upregulation, as we just mentioned, and clinical outcomes. I mentioned this information as well.
Really, really promising data that gives us the ability to move forward on this program. This is the reason why I took this job, is I think that this has the potential to change the paradigm for treating triple-negative breast cancer patients and potentially other solid tumor indications. If we can replicate this on a go-forward basis, the sky's the limit in terms of what we can do for other solid tumors with upregulation of PD-L1, making those checkpoint inhibitors available to other patients who otherwise are not eligible to receive those drugs currently. This is the data that shows the reduction in tumor metastases by 98%. You can see pictorially the control, and at week seven, the masses that they have versus lorazumab, where it's basically 98% reduction in tumor metastases. Really, really powerful data, which gives us the preclinical data that helps us to move forward as well.
This one is where the animals were injected, and then without treatment for seven weeks. What you see in five of the eight animals, there was a reduction by those purple arrows. You can see, again, significant reduction in metastasis. This is just how we got to the 28 patients for triple-negative breast cancer. There are three different clinical trials that had a total of 28 patients that we used to, on a retrospective analysis, gather this information. I give Dr. Lilazeri all the credit for this, going back and contacting the different clinics and patients to pull this really valuable information together that allows us to move forward with our current studies. This is a baseline of the information of those different 28 patients.
You can see the median age as well as the number of prior metastatic therapies that were on, pretty significant as far as that goes, including visceral metastases and brain metastases. One of those patients that I mentioned of the five had brain metastases, and they currently have no evidence of disease. Really, really powerful information that we just need to prove on a prospective basis. These are the different baseline PD-L1 expression levels for the 28 patients that I mentioned. You can see the vast majority of them are in the low, which is less than 400. You want to get to the medium or high to be generally eligible for an ICI drug. If you fast forward, you look at the PD-L1 expression after being on lorazumab for somewhere between 30- 60 days, those are the orangish-red lines. You can see the vast majority induce PD-L1 expression.
There were some, again, this happened during COVID, so there were some patients it was hard to get the follow-up information on. Again, the vast majority we do have, and they did express PD-L1, which is really important. If you fast forward, and this is the information I mentioned earlier, you can see in the second box here, the folks who are on the high dose, the medium or high dose, who took lorazumab and then followed it up with a checkpoint inhibitor are all alive today, and they all actually induce PD-L1. Again, really, really important data. You can see other folks that induced, actually, women who induced but did not follow it up with a PD-L1, unfortunately, are deceased. The other 23 are deceased. This is interesting too. If you look at the bottom, let's see if I can get my pointer to work.
Right here, these are the CPS scores that the women had at baseline. For triple-negative breast cancer, the threshold is greater than 10 on a CPS score. Four out of five of these women would not have been eligible for a checkpoint inhibitor. You fast forward, you can see that they did take the ICI afterwards, and they again are all alive today. Really, really important data. Just looking at progression-free survival as well as overall survival, you can see the significant difference in the curve, so to speak here. Again, great data, again, that gives us the confidence to move forward in triple-negative breast cancers. Let's turn to colorectal cancer. We currently have a phase two study in colorectal cancer. It's currently enrolling. We are currently up to six clinics that are enrolling. We have one very high-volume clinic that just came online.
We are expecting to have between 15- 20 patients enrolled in the study by year-end. That's important because we're looking at that PD-L1 increase, and we'll have that hopefully in the first quarter of 2026 to be able to report that out. We're currently at six clinics, and we should be around nine by the end of the year. You can see what gives us the ability to move into colorectal cancer is we did test five patients previously, and three of those five showed a response with two patients demonstrating a partial response and one patient with a complete response. That gave us the confidence to move into this as well as the other slide that I showed with the CCR5 levels and the PD-L1 levels at baseline. You can see it's a, I think, a fairly low bar.
Lonsurf is currently approved, and you can see those data that shows the overall survival is, again, a low bar for a very important disease. We're currently enrolling. We're expecting those readouts that I just mentioned on the PD-L1 levels in the first quarter of calendar year 2026. You can see the randomization. We're looking at enrolling 60 patients. It's a two-hour multisector study. The lead investigator is Dr. Kazi. His clinic is a clinic that's very active and has lots of patients in prescreening and screening currently. This is the marketing data that we have on colorectal cancer. It's currently a $21 billion market that is expected to grow to $28 billion in 2030. Sadly, a large market opportunity for us. Let's just take a step back and look at our clinical priorities. These are important to us.
These are almost as important as the ethics and goals because this is where we're uniquely focused right now. We're prospectively demonstrating induction of PD-L1. You heard that throughout this presentation in one or more CCR5 solid tumor types. Prospectively demonstrate clinical benefit with ICIs with PD-L1 induced patients. We think that could grow the market significantly for all those ICIs out there. We're looking forward to hopefully at some point collaborating with them in the future. We're trying to be active. We presented at HCW. We're here today. I'll be at BioEurope in November. Looking forward to getting meetings on the books there. We'll be at San Antonio Breast Cancer in December, which is the world's largest breast cancer symposium. We have some data to present there as well. Really working hard to get the right deal for the company that moves our programs forward.
Then demonstrate PD-L1 levels on circulating tumor cells that correlate with PD-L1 levels in the microtumor environment. Here are our upcoming milestones. We hit the first one. We did present at ESMO in Europe and showed the presentation of cold-to-hot mechanisms of action. We're looking for, we do have a very, very, very, very high net worth individual who has agreed in principle to fund our expanded access program. We're looking forward to closing that in the very near future. That'll be a nice outcome. Those will be in triple-negative breast cancer patients who are otherwise ineligible or unable to be in our planned phase two clinical trial. We're looking forward to the FDA clearance of our phase two trial in triple-negative breast cancer as well as the expanded access.
We're looking forward to the submission to the FDA, the inclusion and timing of adding the ICI into the colorectal cancer study in the fourth quarter of calendar year 2025. Initiation of TNBC expanded access, which I mentioned there, readouts from the colorectal trial in the calendar year 2026 for the PD-L1, and initial readouts from the colorectal as well as starting the clinical trial in 2026. We're very much focused on these goals. I just want to thank the shareholders for their continued support, for patients who are doing everything we can to help out triple-negative breast cancer, colorectal, and hopefully we'll be able to expand that market to other solid tumor, at this time, solid tumor indications. With that, we have two minutes. I'm happy to answer any questions that you may have. Hi, yeah.
Talk about Eric Ashburn right now. He needs to go to market in the near future. You know, he hasn't been cloud some.
Yeah, so the question was around financing. As of the end of August, we had just over $9 million. We haven't given cash burn guidance, but we will need to go to the market at some point. We're looking at different opportunities. I'm very sensitive to doing the right deal, similar to the BD type information. We do have about $3 million- $4 million available in warrants that can be exercised. I mentioned that high net worth individual, that's an initial investment to support the expanded access program. I'm looking at different opportunities in that regard. There could be, you know, we're looking to do the right deal on the business development side. There could be a potential influx there as well. Again, it's early days on that, but we're hitting the ground hard to look for the right financing. Good question. Any other questions that anyone has? Yeah, please.
Will you be presenting the task force?
At where? Sorry.
Task force.
We are looking to put in an application to present there, correct, yeah. We'll be there for sure because it's the biggest oncology world event. Yeah.
Are there any plans in the past of FDA Fast Track or anything like that?
Interestingly enough, we do have Fast Track designation for triple-negative breast cancer. I would like to look at other different FDA designations that we could get. It would be eligible for, based on the number of patients, for orphan drug designation. We're actively looking at the potential for that. Yeah, good question. Any other question? I guess I'm out of time. Thank you so much for your attendance and really appreciate it. We do have a, sorry, one last thing. We do have a full schedule for the rest of the day, but my email is rhoffman@cytodyn.com. We also have ir@cytodyn.com. I'm happy to have any follow-up meetings that you may have. Thanks so much.