All right. Good afternoon, everyone, and welcome to the H.C. Wainwright 28th Annual Global Investment Conference. I'm Dr. Katherine Degen, an associate at the firm, and I'll be your moderator for this session. We're pleased to welcome Brian Gastman of Iovance Biotherapeutics. Mr. Gastman, thank you for joining us and take it away.
Yes. My name is Brian Gastman. As mentioned, I am the EVP of Translational Medicine and Research at Iovance Biotherapeutics. On behalf of myself and the company, we'd like to thank H.C. Wainwright and their teams for allowing us to speak today. As you can see, there's a lot of detail here related to forward-looking statements, which as you can read in the slide. The key message here is that Iovance has taken TIL therapy from science and academia into commercial reality. We're using this as a platform to bring these type of treatments across multiple solid tumors. As a brief overview, we are the global leader in innovating, developing, and delivering TIL therapy for cancer patients. As you can see, we have two therapies that are approved. One is Amtagvi, which is our flagship TIL therapy.
The other is Proleukin, which is also called interleukin-2, mostly supports Amtagvi but has other uses too. Both are commercialized for our company. As you can see, we've treated over 2,000 patients, both clinically and commercially, which is by far the largest ever. At the middle, there's some information about market access. I'm going to get more into that as we proceed into this talk. I want to focus a little bit on the right side, which is our recent company financial disclosure. We had a record quarter in Q2 with nearly $100 million in revenue. Our margin is now 56%, which is the best ever, and we have cash runway over $300 million, which is enough to take us into mid-2028. Moreover, allowed us to now announce that we have a clear line of sight to profitability.
This slide describes how TIL therapy is made for patients. Before I mention that, though, you should know that I spent 18 years as a surgeon, physician, scientist, and trialist with a heavy focus on TIL physiology and how to overcome tumor immune evasion. Joining Iovance was an opportunity to see that realized in a form to actually treat the same patients that I was struggling with in the clinic. What you should know is that TIL is a one-time therapy made from the patients for that patient. We take the tumor from the patient through a small surgery. The immune cells that are in that tumor are very specific in that patient and used to be revitalized and expanded into the billions and given back with a preparatory method right to the same patient that we took it from.
These are the same therapies that have been around for a number of years, which Iovance then came along and scaled, and now are able to develop this, as I mentioned, as a true platform to help patients across solid tumors. We do this in our central manufacturing hub in Philadelphia called iCTC or Iovance Cell Therapy Center.
As you can see, this allows us to bring in specimens, tumor specimens, as mentioned, from around the world and allow us to send the same base material in a cryopreserved form as far as the Far East, all through Europe, Asia, and certainly throughout North America and beyond. This facility supports both clinical and commercial supply. Currently, it is modular with a capacity of over 5,000 patients. The main point is that this manufacturing is not just for operational capabilities. It is a strategic asset that supports supply control, margin expansion, and operating leverage as our volume continues to grow.
Again, with the theme of being a platform, the same way we make melanoma TIL therapy, we can bring that to other tumors as well, especially large indications like non-small cell lung cancer, which I will discuss a little bit later, as well as sarcoma, soft- tissue in particular, as well as endometrial cancer. In some ways, this is a de-risked platform because the cell therapists that we work with are the same across all cancer types. Many times it is the same surgeons that we are working with and in occasion, the same medical oncologist. This helps us to relaunch this drug, right now in clinical trials, but eventually commercially for all these other indications. Focusing on melanoma, there are over 8,000 melanoma deaths a year in the United States.
That is a very large unmet need. Really those patients heretofore, until we were approved, had nothing in the label in terms of refractory disease to frontline therapy, where so much success has been seen. Worldwide, you could see that number balloons to 22,000, but we are now working on a way to bring this even earlier to frontline disease, and you could see the number exponentially gets even bigger. This is a very large market opportunity alone just within melanoma, an area that we are getting better and better at as we speak. These data that I am showing you here is the basis of the trial that led to our FDA approval as well as our approvals in Canada and in Australia. As you can see, the overall response rate as well as the five-year overall survival is unprecedented in this highly refractory population.
What is really key here is in that upper right-hand corner. You can see the tail of durability. You only usually see this in immune checkpoint inhibitors in the front line. This is literally as Kate Keating used the word unprecedented, but it really is unprecedented. There is no other drug that I know of in this area, in this level of disease that has this type of durability. As you can see, we measured it finally at five years in terms of its median of over three years. When you run a trial like that, many say, "Well, maybe that is only in a controlled setting." We then went to four major centers that were mature in their ability to give TIL therapy, and we looked at their results up to that point a few months ago.
We found pleasantly surprisingly the response rates were even higher at 44%. This was driven mainly by the second-line population, which is a true on-label population with over 50% response rates. This is key because we believe as we take the same patient but get them into the true second line, we will see these kind of results throughout the U.S. and beyond. There are other measures we can do to get these numbers even higher. Without having to do any modification, any additional scientific evaluation, just working on operational excellence from the patients themselves to the doctors to our manufacturing, we believe that this is not even the ceiling of where we can go. Our Authorized Treatment Center or ATC footprint is quite large. As you can see, we are highly concentrated where the patients are.
This is key because we want to maximize patient access. Patients don't want to necessarily travel far. Their doctors don't want to send their patients far from their home bases either. Thus, you can see the strategy here. We have over 95 centers already, mostly all the well-known centers you can think of. In addition, around 1/3 of these are in the community, and that is growing as well. We expect by the end of the year to hit 110, and we will go beyond in the following years. From a market access point, on the right you can see that already what I just showed you in a footprint is that over 95% of patients are within a 200 mi driving distance in continental U.S., and over 80% a 100 mi. That is also getting better as we strategically add more centers.
In addition, from a payer coverage, which is a big deal if you don't have this in terms of having a blockade to accessing our therapy, we've over 250 million lives covered in payer policies, including Medicare and commercial payers. That covers over 75% of the U.S., and these numbers continue to get better and better, really hindering any reasons why patients should not be able to get this life-preserving therapy. I mentioned earlier about the potential of going into the front line. So we actually performed our IOV-COM-202 Cohort 1A trial. This trial was looking at TIL therapy plus pembrolizumab in the ICI-naïve population of advanced melanoma. What's key here is that not only when you added TIL to pembrolizumab, an X plus PD-1 setup, we saw incredibly high response rates in the mid-60s. But that CR rate, I hate to use the word again, but it's unprecedented.
That is a very high CR rate of 30% at the time that this was analyzed. Dr. Rosenberg and the NCI show that if you get a CR with TIL therapy in the front line, at 10 years, 96% of those patients were alive, and that included from car accidents or what have you. It's a tremendous goal to hit those kind of numbers. From an X plus PD-1 perspective, I would argue this is some of the best results you'll ever see. On the right, you can see patient-level data. These data are even more mature than what I'm showing you here. In ESMO, there'll be an oral presentation on these data, which you can also see on iovance.com. This is also the experimental arm essentially of our phase III international confirmatory trial, also called TILVANCE-301. That trial is running as we speak.
It's well underway. It's international. It's at many dozens of centers as we speak. The goal of that trial is multifold. One is to confirm our second-line accelerated approval. Secondly is to also get accelerated and ultimately full approval in the front line as well. Here I'm showing you our strong and arguably the largest and most robust pipeline in all of TIL therapy oncology. We have both our platform of our standard TIL going into various indications, as well as our genetically modified and other next-generation programs. You should know this is just a snapshot of some of what we are doing. Part of what I do is run early phase development in the company, and we are developing next-generation therapies that aren't listed here that I'm very excited to eventually be able to bring to you. But for now, let's focus on what I have on the slide.
Let me start with bringing the same TIL therapy I mentioned earlier to non-small cell lung cancer, specifically non-squamous type, wild type for EGFR, ROS, and ALK, which is actually the most common form of lung cancer. You could see the unmet need is huge. It's much larger than melanoma, at least 7x larger in terms of deaths in the U.S. alone. We have shown multiple times through public pathways a stable nearly 26% response rate as recently as last year. What's key was when we presented that data with over two years of follow-up, the median duration of response was still not reached. This is very akin to what we saw with melanoma. We are imminently finishing this trial very soon. I mean, really very soon.
We expect to have a much larger dataset presented by the end of this year, all leading to an sBLA in 2027. We are not just moving silently alone, but we do have regular interaction with the FDA, and that led to our Fast Track designation. As we know, the unmet need is so large and the goal of getting this to patients as soon as possible is something that we and the FDA share together. Moving to soft tissue sarcoma. We worked with, actually right here in New York City, with Memorial Sloan Kettering, one of the largest and best sarcoma centers in the U.S. and around the world, and initiated a sponsored trial in soft tissue sarcoma types, undifferentiated pleomorphic sarcoma, or UPS, and dedifferentiated liposarcoma, or DDLPS. These are really morbid tumors which have terrible second-line options, which is what we focused in on.
To give a point, the approved drugs have response rates less than 5%, and these are the ones in the NCCN guidelines. You could see with our first cut of available patients, we had a 50% response rate in those patients, all of which are ongoing and in some cases deepening. What's key here is that we are going to give more data on this at ESMO through another oral presentation by an investigator here in New York. This has now turned into a registrational trial, also called SARATOGA. This is now on ClinicalTrials.gov, which you can go to to get more information. But this is a disease which really also exemplifies our ability to platform the same therapies and to move essentially to the same doctors. These are the same surgeons, the same cell therapists, and there is this idea of a mel- sarc oncologist even, melanoma sarcoma.
We are very excited because of the concentration of these patients and the fact that we are already working with the same doctors who take care of them. Moving on to endometrial cancer. This is really where we are starting to use precision medicine biomarkers to evaluate subtypes of the populations we are studying. In this case, we were studying signal in all forms of advanced endometrial cancer. Again, pleasantly surprisingly, we found a specific signal in serous endometrial carcinoma. Anybody who deals with this cancer knows they make up 40% of all the deaths of that disease and is likely the most refractory form of that disease.
The fact that TIL therapy had a 40% response rate in the population that we studied with 100% disease control rate is obviously something we cannot unsee and is why we are moving forward with our engagement with the FDA, and looking for other ways of getting expedited pathway review. It is important to note that these are another form of cancers that are treated in the front line with a PD-1-based therapy, and there really is not anything of significance when those are failing. Finally, moving into our next- generation pipeline. What you can see is that we have both pipelines for TIL therapy as well as our Proleukin platform as well. In TIL therapy, we have the first ever genetically modified TIL therapy called IOV-4001. This is PD-1- inactivated TIL therapy. This is important because we are bringing the inactivation where it counts into the tumor microenvironment.
This has been tested now in melanoma. We have moved into non-small cell lung cancer, and we are really just finding where to optimize this therapy so we can really take this technology and move it to really where it counts. Next is our IOV-5001 program. This came straight out of the lab that I, again, manage and very excited for the team that did all this hard work. This is actually based on a human clinical trial. There they used what they already knew, which is that IL-12, when given intravenously, is very effective at treating cancer, but it is extremely toxic. They tried to do better than that by giving a TIL therapy which secreted IL-12. Actually, the TIL therapy was incredibly powerful, at least twice the response rates versus the standard TIL therapy, for example, that we give.
The problem was the secreted version of that is the way that the cells let the IL-12 be released and unfortunately went into the entire body, and they started seeing those same side effects. How to get around that? Imagine genetically engineering a TIL therapy that expresses this IL-12 but gets stuck at the cell surface and only does so when it is in the tumor microenvironment. That is what we generated, a TIL therapy that will have IL-12 associated with it without it getting throughout the body and causing side effects. Because of the power of these cells, we want to see whether we can go where heretofore TIL could never go before.
Colder tumors, big indications, colorectal cancer, think triple negative breast cancer, head and neck, et cetera. That is where we are taking this. It may go well beyond that, but expect this to imminently also start accruing patients.
Finally, in the middle is our IOV-3001 program. We know IL-2 is an excellent T cell growth factor, but it's got positives and it's got negatives. How to exemplify the positives and minimize the negatives through genetic engineering, that's what IOV-3001's about. It is in a dose- escalation trial as we speak, and there'll be more information very soon. As always, all this information that I'm telling you is available on iovance.com. To reiterate and to recap, Iovance continues to be the global leader in innovating, developing, delivering TIL therapy for all types of cancer. We have two major assets, as I've described, that treating over 2,000 patients clinically as well as commercially has developed a tremendous amount of information that really gives us experience to be able to go further than we have that is quite unique.
It's also allowed us to build relationships that no one else has because of the hard work to get here. You saw our market access approach and how much we are getting to the patients, which has always been the issue. TIL always has worked. The problem was always getting it to the patients, and I think one of the things that Iovance is doing right now is solving that major problem. Finally its our best quarter ever. You saw our quarter financials, almost $100 million in revenue, 56% margin. That margin is getting there because of operational excellence, reducing unnecessary costs, and just in general, getting the kind of patients that we always knew we should have, which is the same patients just slightly earlier in their journey.
This has all led to our cash runway, which will take us into mid-2028 and allowing us to have that future-looking assessment into profitability. With that, I'd like to thank you for your time and attention, and I'm happy to take any questions.