Welcome back to the NWR Virtual Healthcare Conference. Joining us next is Dr. Rebecca McQualter from Chimeric Therapeutics. Chimeric is a cell therapy company which is developing next generation treatments for cancer, including CAR T and NK cell therapies and has multiple clinical stage assets. Rebecca will outline how the company is advancing this pipeline to bring these innovative treatments to patients. Rebecca, over to you.
Thank you so much, Matt, and thank you NWR for having me today. I also want to say thank you to Matthew for his continued support, doing all of our IR for us at Chimeric Therapeutics. Here's my disclaimer. I will be making forward-looking statements today. If you're unaware about Chimeric Therapeutics, my name is Dr. Rebecca McQualter. I've got a Ph.D. in cell therapy from Monash University here in Melbourne. We have now two cell therapy assets across three FDA INDs, all running in trials across the U.S. Really the investment opportunity is at a great entry point right now, and we have multiple clinical updates coming across the next six months. I think one thing that's unique to Chimeric Therapeutics is our expansive experience in cell therapy across our leadership team.
All of us have worked on the commercial cell therapy products, and we know exactly how to get this to market, particularly my head of manufacturing, and I'll share some great news about her efforts shortly. We are currently sitting at AUD 0.002. Our ticker is ASX CHM, and like I mentioned, we're a great entry point. We've recently completed a little bit of pipeline consolidation, and I think this is really kind of focused on, you know, how we're getting our capital and really where we want to put that. And so we focused our pipeline now onto two core assets. The first one is CHM CDH17, which I'll be able to give you an update on today, and also our off-the-shelf product, CHM CORE-NK, and that's a relatively inexpensive program.
With that, we really focused our capital on executing these studies well past phase I and into phase II. We've recently had a new board appointment, our Chair, Dr. Bradley Glover, who also has significant cell therapy experience, formerly working for Kite in the U.S., and he's based in San Francisco, to really help us on the ground with all of our BD discussions that will be upcoming. All right, let's move on to CHM CDH17. Just a quick background for those of you who aren't familiar. CDH17 is actually a marker that's expressed on different types of cancers, basically from the mid-gut all the way down, and they sit on top of the cancer kinda like that. That makes it a really good target for the cell therapy to be able to find them and kill them.
In the animal models that were published on the cover of Nature Cancer, which we're very proud of, each animal model that was tried, so neuroendocrine tumors, which are kind of in the mid-gut, gastric cancer, pancreatic cancer, and also colorectal cancer or bowel cancer, as it's more commonly known, the tumors were completely obliterated using the third- generation CAR. This CAR is what we've taken into the clinic, and we're moving quite rapidly through phase I right now. As I mentioned, our phase I, we're almost at the end of phase I, which is very exciting. We've made a lot of really good progress.
We have four active sites in the U.S., Sarah Cannon, which is in Nashville, Tennessee, UPenn, which is in Philadelphia, which is the home of CAR T cell therapy, UChicago in Chicago, and then Emory in Georgia, Atlanta, which is a fantastic site. You know, just a little bit of history about this particular asset. We were given our FDA IND in November 2023. We dosed our first patient just under a year later in August 2024. We received a Fast Track Designation in 2025, and then at the end of 2025, we received an Orphan Drug Designation. These are two things from the FDA which are very important.
Fast Track Designation means that we have a group at the FDA, of cell therapy experts that can help us move through all of the regulatory hurdles that we need to get onto the market in the U.S. This is really important in this particular time, in the U.S. kind of, climate that's happening right now. With the orphan designation, it means that we're eligible for, tax cuts and different things like that in the U.S. once we head to market. These are two really important milestones for this particular program that all of our potential partners are looking for us to tick those boxes. As I mentioned, my head of manufacturing's been doing a very, amazing job, and we've had 12 out of 12 successful runs.
We've maintained our GMP compliance with the FDA, and we've also recently passed all of the different FDA checks that we needed to undergo. She's done a lot of heavy lifting there with our manufacturing facility in Philadelphia, but I'm very proud of her work with a 100% success rate, which is pretty rare in cell therapy. We've had a few tricky patients where she's really had to get hands-on, and fly over to Philadelphia and get in there, but very happy that we've maintained our 100% success rate.
I think I've mentioned a few times that manufacturing is the backbone of cell therapy because we're manufacturing at a one-on-one basis, and so this remains very important that we maintain this high GMP standard with our 100% success rate. I wanted to share with you today the clinical trial design and sort of go through that in a little bit more detail. We currently have Dose Level 3 open, which is part of the dose escalation exploration phase. I don't know if you can see my mouse there, Matt. But we've also maintained Dose Level 2 open. We still have one patient that needs to be treated in that dose confirmation piece, of Dose Level 2 . We've sort of finished Dose Level 2 . We just have one more patient, to finish, but we're progressing with Dose Level 3 .
Dose Level 3 is 450 million cells, and that's one single dose for every patient at each dose level. Once we, you know, sort of start treating more patients at Dose Level 3 , we'll determine if that's the right dose to move forward into the dose confirmation section of the trial. As we start thinking about the end of phase I, as we've reached 12 patients enrolled now and we're heading for 15, we're pretty close to the end. We're sort of thinking about, okay, how do we get ready for phase II, and who's waiting in the wings for that? Do we need a dose-specific, indication-specific kind of program? That's kind of where we're thinking right now. This is all in flux once we move through the doses.
I'm not gonna go through each patient, and that's gonna take me a very long time in my 20- minutes that I have today. Again, I wanted to share with you the continued success of our patient that's at dose level one. She's now 15 months with no new tumors. Her tumors have remained small in size, and her hair's grown back so beautifully. We're really delighted with her chemotherapy-free, progression-free survival status, which is really important. We have another two patients behind her, one at nine months and one at six months from the Dose Level 2 cohort, who have also maintained this chemotherapy-free, progression-free survival state, which is fantastic. It's worth noting that all the patients at Dose Level 2 to date have achieved stable disease by their first scan at day 28.
We treated our first patient with Dose Level 3 . We're still awaiting for his complete package to come through for his results. We've got one patient that's been manufactured for that's ready to be treated. We also have four patients that have been wait-listed for that Dose Level 3 slot. Because colon cancer's on the rise in the U.S., and particularly that younger demographic of between the ages of 25 to 45, we actually have a lot of younger patients. This is probably more suitable to the cell therapy indication because their cells perform beautifully through manufacturing. A lot of our patients, we have a median age of about 45, so they're on the younger side.
We're really delighted about what we're seeing, and I hope to be able to share some information soon about how Dose Level 3 is tracking. I think you would have seen that our Chairman put out a letter not that long ago, two weeks ago, and we're sort of gonna change the way that we communicate. I wanna be really clear. We wanna make sure that we protect our patients' identities because, you know, we're dosing one patient and waiting 28 days and dosing the next patient. We're gonna kind of batch the results as we can. Don't be nervous if you don't hear from me for four weeks. That's totally normal, and I think I'm very happy with that cadence of results being released.
Just quickly on the global market size of the four potential indications that we have with this particular product. It's about a $27 billion market, but I think what's worth noting is that the current standard of care is chemotherapy or surgery. You know, our patient that was at Dose Level 1 that's now 15 months progression-free, you know, she had five years of chemotherapy beforehand. We really wanna find a space where that's no longer the case, and this is why we're testing this particular product in second line, so they only have to fail one round of chemotherapy before they're eligible, and this is the way that my CMO designed this trial. We think that's really important.
The market's growing year on year, and we're kind of in a really good spot to address the gap in the market. Just in summary, we've had 11 patients treated. We've got 12 enrolled. We've had 12 out of 12 successful manufacturing runs. We've seen a fair bit of anti-tumor activity, with no safety issues and no off-target issues to date. For FY 2026, you know, it's pretty simple. We've got to finish this phase I trial, and complete Dose Level 2, finally get that last patient treated in Dose Level 2, and finish Dose Level 3. We'll conclude the phase I and really start to think about what we need for phase II. We need a partnership. We've got plenty of patients waiting in the wings.
That's not gonna be a problem, but really working towards that, which will be great. I'm gonna move on and give you a quick CHM CORE-NK update. We've had a lot of questions about this particular program, and so I just wanted to provide a top-level update. This particular program is an off-the-shelf product, and these are natural killer cells that haven't been engineered, but our manufacturing process is what we own the IP for, and that really revs up the NK cells to get in there and start fighting. I think you've heard me say that, the natural killer cells are like the Batman cells of the immune system. They really provide that one-two punch for cancer, and so we've really seen that in some of our results. Now, there's no new information here, and there's a few reasons for that.
We have two phase I-B trials that are running at the moment. The first one's at MD Anderson Cancer Center, and these two trials are investigator-initiated trials. What that means is that MD Anderson approached us to use our technology. They run the trial. They pay for the trial. Any updates that we receive from MD Anderson, you know, we're really relying on our relationship there. We're not in control of the database, and we can't see the database, so we can't provide regular announcements. We're really relying on MD Anderson to communicate to us what's going on. There's, you know, sort of no formal obligation there for them to do so.
We're really lucky to have a great relationship. Our phase I trial happening at Case Western has been suspended, and that's nothing to do with our technology. It's because of a worldwide IL-2 shortage, which is included in the protocol. Once that issue resolves, the suspension will be lifted, and the trial will continue to recruit. You won't hear any updates on that particular trial until they solve the IL-2 problem. As I mentioned, the bigger trial happening at MD Anderson Cancer Center is including standard of care, and this is in blood cancer patients with AML. We're actually dosing patients front line. They get our NK cells first. As I'm aware, that's the only study that cell therapy is being used front line in the first line of therapy.
These are in patients that aren't eligible for a stem cell transplant, so they're quite unwell patients. To date, this is an announcement we made late last year, but we've had one complete response in the dose confirmation kind of phase and another three in the first line dosing. I'm hoping to get another update from MD Anderson shortly and to see how the recruitment's going and where they're at with the complete responses. Like I said, this data is owned by MD Anderson, so we're really relying on them to provide us that update. Quickly for CORE-NK and our priorities around CORE-NK, we really want the dose escalation to be completed.
We want this first kind of phase I-B study to be finished and completely enrolled by the middle of the year. It will be a discussion with MD Anderson how we move this into phase II, if they're keen to move it into phase II and if they have the funding to do so. Our main deliverable is to dose 20 patients with MD Anderson in FY 2026. Just to summarize my quick update today, we're really moving forward and progressing the trials and just delivering on what we need to deliver, and I'm very happy with our nimble team that we have now. We're able to continue the trials in a very cost-efficient way. We're really looking at how do we continue to reduce the COG.
We're working with our manufacturing partner in Philadelphia and looking at automation and how we can include automation in our process, and our head of manufacturing is working very diligently on that. As I mentioned, we've had a 100% successful manufacturing rate. We've had 11 patients treated in the CHM CDH17 phase I trial, and we're barrelling towards the end of phase I, which is really great. For CORE-NK, that's ticking along with MD Anderson in charge there. We're really moving forward. With that, I'd like to conclude my presentation today, and if there's any questions, please let me know.
Thanks, Rebecca. Again, as a reminder to the audience, if you have a question, please type it in using the Q&A function within Zoom, and we'll jump through a few of those now. I know you've touched on it there, Rebecca, but a couple of questions around the updates on Dose Level 2 and obviously three. I mean, what's your expectation there around when the additional information will become available to be announced?
Yeah. As soon as we have a decent data pack, it'll be in the coming weeks, then we'll be able to announce that as soon as we've got the complete data set.
Mindful of sort of not saying too much, but has there been any commercial interest shown in the current treatment platforms?
We've had a fair bit of commercial interest, and we really need to deliver results at the end of phase I to continue that commercial interest. There was a fair bit of activity earlier this year. We've been given a hurdle to jump, and we're currently trying to jump that hurdle. Once we jump that hurdle, we'll be in a really good place. Looking forward to the Dose Level 3 results.
Can you just provide a bit of context around what's been happening in the CAR T and cell therapy space more broadly?
We did receive a question about this last night, which I was grateful for. There's actually a lot of action been happening in the CAR T space recently. I'm not gonna say that CAR T is back, but we're sort of heading out of the no man's land curve. This morning, Gilead paid $2.2 billion to Galapagos to continue one of their cell therapy programs, which is a really great sign. We had Cellares, who did a huge fundraising of $275 million a few weeks ago for their automated cell therapy manufacturing business that they have. We've seen a few bigger transactions out of China, which have been really interesting.
Not only in the in vivo CAR space, which is using the body as the manufacturer, but also in the ex vivo space where we play, there's been quite a few deals. I think what's really important to note for CHM shareholders is that our technology can be used across the ex vivo platform, which is using a manufacturing facility, but also in the in vivo platform, which is using the body as the manufacturing facility. If I had all the money in the world, we'd definitely be adding that to our pipeline, but that might be something for us to consider later down the track.
Thank you. From a risk and execution perspective, how do you see that over the next 12 to 24 months? What keeps you up at night, I guess?
I'm really happy about how our clinical operations are running, and I think we're in a really good spot in the business. We've trimmed all the fat out. We've trimmed all the excessive consultants out. We've really streamlined the spending, and I'm really happy about how the clinical operations are running. I think that things that keep me up at night are obviously you know what happens if the borders close between Australia and the U.S.? We can maintain our trial over there. You know what's gonna happen with the global kind of climate? I think the other thing is you know we keep getting a lot of questions on governance, and we spend a lot of time and money on governance. I just don't know how to improve that anymore.
We're doing the absolute best we can with all of our advisors, and so we've really whipped the business into shape in the last 18 months, and so I'm really happy how that is at the moment. They're probably the two things that keep me awake. I think obviously our share price needs to change, but that will come when we deliver the results.
Very good. And you mentioned having a new chairman on board. I don't want you to have to speak for Bradley, but what do you see as the priorities for you and he over the rest of the year?
Yeah. I think for Brad, the number one priority that he stated very clearly is governance around the business and maintaining that kind of high standard that we have already. I think he's also really keen to help us to use his network across the U.S. in all of our BD discussions. Because he's based in the Bay Area in San Francisco, it's really easy and more cost-effective for him to duck into a meeting than for me to fly over. We're really excited about that. I think his network is really fantastic, and he's been a great addition to the CHM board.
Very good. Well, that's all the questions for today. Rebecca, thanks for your time, and we look forward to hearing more from you very soon.
Thank you so much.
Next up with the NWR Healthcare Conference, we have one of our private companies, [audio inaudible], in at 10:30AM Eastern Time. Hope you can join us for that one. Thank you.