Good morning, everyone, and thanks so much for joining us. I'm Anthony, an associate here at Oppenheimer, and it is my pleasure to introduce Marker Therapeutics. Marker is an immuno-oncology company focused on developing T-cell therapies using its multi-antigen recognizing or MAR-T platform. The lead program is MT-601, and it's being studied in relapse lymphoma, where we've seen encouraging early response data along with favorable safety. The company is also advancing an off-the-shelf AML program and is expanding into solid tumors. We're pleased to welcome Dr. Juan Vera and the Marker team to walk us through the story. Juan, I'll turn it over to you.
Thank you, Anthony. Thank you for the invitation. It's really a pleasure being here. Marker Therapeutics is a public company, and I believe that it's advancing a technology that is quite unique, right? Let me start by outlining this in this slide. Without a doubt, multiple drugs have approved the market, multiple cellular products, and have been quite transformative. I think here we have an example for CAR T cells, alpha, beta TCRs, and TILs. However, one of the things that I want to highlight is Marker platform and technology is unique and is first in class. Although there are certain similarities with some of these compounds that have reached the marker, there are substantial differences, and they are outlined here.
The main differences with the Marker technology, MAR-T cells, it's a technology that is natural, does not require genetic modification, is capable of targeting multiple target antigens. We have seen an excellent safety profile in our current clinical studies. We're really excited of advancing this with the objective of taking our lead product, MT-601, into the market, particularly in lymphoma, with our lead asset, MT-601. Let me walk you through our current clinical data and plans. Marker Therapeutics is a company that is advancing a first-in-class compound, MAR-T cells, developed at Baylor College of Medicine. The company has the worldwide intellectual property for this technology licensed from Baylor. Our lead asset, MT-601, is a product that recognize multiple different antigens present within the tumor.
I believe that these multi-targeted strategies, perhaps one of the things that make it different and will help in the ability to recognize the tumor and modulate the mechanisms used by the tumor to evade immunological recognition. The clinical efficacy speak for itself. Today, we have seen in patients that are heavily pretreated and refractory to multiple lines of treatment, we have seen in non-Hodgkin lymphoma an overall response rate of 66%, and in Hodgkin lymphoma, an overall response rate of 78%. This is quite remarkable, seeing this level of response rate in group of patients that have failed multiple lines of treatment. Again, it highlights another important element of the technology, and is the ability to move outside of the CD19 targeted area, right? Again, you can target things like Hodgkin that is CD19 negative, right?
Very important for us and patients is the safety profile, right? Of the use that we see today in the clinic, we have seen no ICANS. We have seen an excellent safety profile with no HLH and low-level CRS that have been only fever, right? Really an excellent safety profile, which will make this very attractive for patients in the future. I think that we have received significant support from the government, from NIH, FDA, and CPRIT, from the state of Texas, and I think that this is not only a huge, but we have also received more than $30 million, which I believe is a huge addition to our capital runway that is non-diluted. It's also a huge voucher of endorsement to our science clinical plan, right? I think that this is something that we are also very proud of.
As I mentioned before, let's go into subject matter. As I mentioned before, Marker Therapeutics is advancing MAR-T cells, which is a first-in-class technology. This technology is a natural product which we isolate from the patients themselves. They get stimulated with overlapping peptides. These peptides really represent the target antigens in a synthetic manner, and in that way, we're able to amplify tumor-reactive cells, T cells that are capable of recognizing multiple targets present within the tumor. In that manner, you have a final product that has the ability to recognize multiple elements present within the tumor. Again, we do that in a natural manner without the need for genetic engineering. Our current vein to vein time is about 22 days. We anticipate this year to bring this down to about 17 days.
The manufacturing process itself is pretty straightforward, and many of you have seen this similar cartoon in other cell therapy programs. I think that that's where the similarities start and end really. You have a patient material. This is then isolated from the clinical site, sent to a centralized manufacturing facility, which is located in Texas. There, we isolate PBMCs. These PBMCs that then is simulated with these overlapping peptides in a simulated ex vivo for about nine days. At this point, the cells are then collected, cryopreserved, characterized, and then sent to the patient, sent to the clinical site in a cryo manner. As I mentioned before, our vein-to-vein time is about 22 days, but we're working currently to make that shorter, and hope to implement this later this year.
If we look into our lead assets, you see here MT-601. One thing that I want to point out and clarify is you see MT-601 as a Phase 1. This is a Phase 1, Phase 2 clinical trial. It's an adaptive trial design. Our anticipation is to advance this Phase 1 into a single-arm Phase 2b that will be pivotal. We'll talk about that in just a moment. One thing that is also important here to note is that you see our same asset, MT-601, on the bottom of the slide, right? We're advancing the same product, MT-601, in pancreatic cancer. Again, another element that is quite unique, and it's being able to advance the same compound beyond hematologic malignancies, right? You cannot do that with CD19 CAR T cells or CD22, right?
Finally, an off-the-shelf program, which I will mention towards the end of the presentation, right? Now, without a doubt, I believe that the success, the near-term success of the company will be binary and will be anchored in our lead asset, which is MT-601 in lymphoma, right? Now, why are we excited about this asset, and why we have selected to go in lymphoma? This actually is derived out of pre-existing clinical data from Baylor, where the technology was developed. Here we actually have published already exciting results using this technology from the Baylor study, where we have seen durable responses for 5 years, which is quite remarkable, again, with an excellent safety profile in patients with lymphoma. Our objective here is to recapitulate, is not to improve upon those responses.
The way they're planning to do that is by going from 5 antigens to 6 antigens, increasing the cell dose from 10 million to 400 million cells, and also, we have a simplified manufacturing process that increase the potency while decreasing the vein-to-vein time. This is the layout for our current clinical study. This is a standard dose escalation, a 3+3 designs, followed by a dose expansion. In the dose escalation, we're exploring dose ranging from 100 to 400 million cells across multiple different histopathologies. In the dose expansion, which we started in June of 2025, we have started in a particular cohort, which is DLBCL, patients that have been exposed and failed prior CAR T-cell treatment. Let's look into the results, and I think that the data speak for itself.
Without a doubt, we're seeing excellent clinical responses in patients with non-Hodgkin lymphoma. This is an overall response rate of 66%, with a complete response rate of 50%. These patients are heavily pretreated, have failed multiple lines of treatment, including CAR T cells and bispecifics. I think that this clearly speaks to the ability of this drug as a single agent to be able to have meaningful clinical responses that are also durable. If we look into more detail, the durability of these responses, we see here that 3 patients have surpassed a 1-year follow-up, and 5 patients have surpassed the 6-months follow-up, right? Again, our objective here is to recapitulate the Baylor clinical data, where patients that had a complete response sustained this response for up to 5 years.
If we look into these demographics and in more detail, I want to point out here, this is the same data just represented in a table format, is that this is quite remarkable, being able to achieve these responses even at the lower dose level explored within the study. This study explored 100 to 400 million cells, and these patients were enrolled in the initial phase of the dose escalation. Here, even with 100 to 200 million cells, we're seeing complete responses and partial responses that are meaningful. Now, the study has been approved and open enrollment into the 400 million dose cohort, but this dose has also shown to be well tolerated.
My anticipation is to be able to recapitulate, if not to improve in these responses, as we now then open the dose expansion of 400 million cells. One important point here to highlight is that when now we test this also outside of non-Hodgkin lymphoma, in Hodgkin lymphoma, which is a CD19 negative tumor, we're also seeing objective responses that are very important, right? We're seeing an overall response rate of 78%, and this is clinically very meaningful, right? You're talking about patients that have no other treatment options. This is a patient from Kansas that had received our drug. This patient had, in fact, a partial response. You can observe that even though it was categorized as a partial response, it's clinically meaningful, right?
Really proud of the responses that we're seeing with this technology, not only in non-Hodgkin, but also in Hodgkin lymphoma. Again, from the purpose of a patient perspective, as well as the company, I think that an element that is very important in our mind is the safety profile, and one of the things that we have seen really set us apart with other technologies. We have not seen a dose-limiting toxicity. There's no ICANS, there's obviously not LARM, there's no long-term toxicities, as this product is not genetically manipulated. The only effect that has been seen has been a grade 1 CRS that has been reported, that it is fever that has not required any treatment. I think that this also create a big market opportunity.
Here we see that the global market opportunity in this particular niche indication, which is LBCL after CAR T-cell treatment, could represent a more than a $3 billion market by 2030. All right, let's stop here for a moment and calibrate, right? We are aware of the current reality in term of our position and ability to take multiple products into the market. As a consequence, our priority today is to advance one product into the market, one product that I believe has the potential to address a unmet medical need in a patient population that really need it, right? With that, our objective is to advance this as a single-arm pivotal study in patients with LBCL that have failed CAR T-cells, right. Our objective here is to take this into the market in a relatively short period of time.
If we fast forward into the future, I think that you will see that beyond what we're doing today, which is MT-601 in lymphoma, there is a huge opportunity here, right? I think this is very different than other propositions and is here the ability to go to solid tumors as well as the ability to go into an off-the-shelf platform. One thing that I want to clarify is that these programs are advanced via the government, right? We have revenue from NIH, FDA, and the State of Texas, right? This will allow us to de-risk these programs as we collect meaningful clinical data. We anticipate to enroll our first patient in pancreatic cancer with our drug, MT-601, in the first part of this year. Again, we're not operating in a blind fashion here.
We have clinical data from a Baylor clinical study, where we have seen that these types of treatments have yield objective, meaningful responses in patients with pancreatic cancer. In fact, this work was recently published at Nature Medicine. I think that that speaks into the likelihood that we're going to be able to see some interesting clinical activity also in pancreatic cancer. Takeaways, MAR-T cells is a first-in-class technology, right? Please don't think about us as CAR T cells or alpha TCRs or TILs. Think about us as a complete different technology altogether. Our lead asset, MT-601, have shown excellent responses, not just from objective responses perspective, but also from a safety perspective, making this a very different proposition.
This is our current cash presence since our last public disclosure, and we have cash into the third quarter of 2026, assuming no additional grants are received. As I mentioned before, the company has received more than $30 million from the government, and if we calculate revenue from those grants, we have cash into the first quarter of next year. If we look into upcoming milestones, we anticipate to complete our tech transfer to our new CDMO in the second quarter of this year. We also anticipate to have additional patient readout in the APOLLO clinical study, and also, to have our first patient treated into their pancreatic clinical study in the first half of this year. With that, thank you very much for the attention.
I don't know, Anthony, if there's any questions, I know we have about 15 minutes.
Yeah, I'm not seeing any questions from the audience, but, you know, I was wondering, as you were laying out the story, what do you think investors most underappreciate about MAR-T versus traditional CAR Ts?
Yeah, that's a very reasonable question. I think that overall, it is a very cold sentiment on cell therapy and CAR T cells. I think that that is basically the overall impression that I've seen. Even though that sentiment might change, right? I mean, we saw a very interesting transaction just yesterday being announced for CAR T cells, right? I think that definitely we have not seen many meaningful deals or acquisitions for cellular therapies. Overall, I think that there is a damp enthusiasm for cellular products and CAR T cells. I think that sentiment is well placed, right? There is multiple barriers that have been observed with CAR T cell technologies, right?
You have complex manufacture, you have a lot of toxicities, you have limited clinical durability, and you have also a market penetration that I would say is quite limited, right? I mean, I think that this therapy can only be used in highly sophisticated centers due to some of those elements, right? The technical complexity, the toxicities, require patients to go to centers that can manage all those different logistical constraints. Yes, these technologies have been approved, yes, they have changed patients' life, but there are multiple different hurdles that have not been overcome. Our objective is to overcome those hurdles, right? I think that our proposition is, yes, we are aware of the limitations, but our approach is different, right?
It's a very simple manufacturing process, does not require genetic modifications, our safety profile is excellent, it's not restricted to CD19, and as a consequence, our strategy is to just get approved in lymphoma initially, but then use the same compound to go across multiple different oncological conditions. It's a fair question, right? I think that overall, there is a very low sentiments or excitement in cellular therapy for a lot of the challenges, as I mentioned earlier on. I do believe that our strategies seek to address all those different challenges with the objective of developing a therapy that it is quite different. When it comes down to what are the challenges, I think that being able to make a separation in term of our technology.
We're not CAR T cells, we are not TILs, we are not alpha TCR, we are a different class technology, and precisely to address all those limitations. Our objective here is, one, and is to develop and give patients a transformative medicine that will be able to change their lives.
Thanks so much. I'm not seeing any further questions from the audience today.
All right.
All righty. Well, thank you, Juan, for making the time.
Thank you, Anthony, for the invitation. Really appreciate it.