Good afternoon, everybody. I'm Stefanie Nacar, Chief Communications Officer at Agenus. Welcome to the October Agenus Stakeholder Webcast, where we'll be discussing efforts to bring treatment options to cancer patients around the world. Before we dive in, a quick reminder that today's discussion includes forward-looking statements. These are subject to risks and uncertainties that could make actual results differ. Please check our SEC filings for the details. Joining Dr. Armen today are two internationally known leaders in the field of oncology and immunology research, bringing deep expertise and insights from both the U.S. and Europe.
Dr. Michael Gordon, Chief Medical Officer at HonorHealth Research Institute in Arizona, will be sharing highlights of the pan-tumor data evaluating Agenus' immunotherapy combination, botensilimab plus balstilimab, also known as BOT/BAL, in refractory solid tumors that he presented just this past weekend at the annual European Society for Medical Oncology Congress in Berlin. We will also hear from Professor Alexander Eggermont, Professor of Clinical and Translational Immunotherapy, who is also a treating oncologist in France, about his perspectives on what the inclusion of BOT/BAL in the French AAC program means for patients in France that are impacted by colorectal cancer.
After the discussion, Agenus leadership, including Dr. Steven O'Day, our Chief Medical Officer, Dr. Richard Goldberg, Chief Treatment Officer, and Robin Taylor, our Chief Commercial Officer, will join Garo for a live Q&A. For the listeners that have joined us today, please submit your questions to the email ask@agenusbio.com. We will be sure to share that again at the end of the discussion to make sure that you engage and submit your questions. With that, I would like to introduce Agenus Founder, Chairman, and CEO, Dr. Garo Armen.
That's OK. Some people call me Garo Armen, Stefanie. Hello to everyone once again. At today's briefing, we will discuss two of our most exciting global developments in cancer that may give some hope to an earlier growing number of cancer patients. When I say earlier, I'm talking about younger patients that are increasingly coming down with things like colorectal cancer, which is quite alarming. As you know, bot either alone or in combination with bal, which is our PD-1, has been studied in more than 1,200 patients across more than nine different types of tumors, across late line settings as well as in earlier settings. When we say earlier, of course, we're not talking about very early stage disease, but in the neoadjuvant setting, where patients have a significant burden of disease before surgery.
We have seen some absolutely remarkable results in those patients in both colorectal cancer, in rectal cancer, as well as in our all-comers trials. What's truly exciting is the consistent efficacy data that we see across various tumor types, including those traditionally considered as cold, meaning resistant to immune response. Those constitute the great majority of cancer patients. The exciting news is that the data presented to date demonstrates the responses improve when you go to earlier stages of disease. As I mentioned, for example, as we go from the very late line stage IV patients that have exhausted all treatments to the neoadjuvant setting, where patients still have significant disease burden, we see remarkably improved rates of responses.
Last week at the ESMO Congress in Berlin, updated data was presented from our phase one study, which, by the way, when you say phase one, this is one of the largest phase 1 studies ever, because we have nearly 1,000 patients in just the phase one cohort of our studies. Dr. Michael Gordon of HonorHealth Research Institute in Scottsdale, Arizona, presented the data. This was in front of a substantial audience. I was able to connect with Dr. Gordon before his presentation at ESMO for a brief discussion about the data. Let's now turn to that discussion that was taped with Dr. Gordon.
Thank you very much for joining us, Mike, here. Dr. Gordon is an extraordinarily experienced and talented investigator, treating physician. He has done a significant number of trials over the years, even though he's young by age. These include a whole gamut of solid tumors. I've had the pleasure of knowing him for a number of years now, probably over 20 years, Mike, when immuno-oncology was a field. All of a sudden, the field has sprung up and become a very, very key component of treating cancer patients with a very different quality of life profile than the typical agents that we know.
I'd like to first recognize the decades of work that has advanced the IO revolution and reshaped cancer care. Today, about 60% of patients have access to approved IO therapies sometime during their cancer journey. Responses remain concentrated in immunogenic, or the so-called hot tumors. Only about 11% of patients have an objective and often a durable response to approved IO therapies. Therefore, the need for novel treatments to extend the benefits of IO to more patients is urgent.
Thank you for that. You mentioned some very important points here. The first-generation IO compounds have been sort of impacting the low-hanging fruit, which you term as immunologically active tumors. This is the next wave, presumably. It's a significant proportion of cancer patients that suffer from immunologically hidden tumors.
I think the most important thing is that we hit an inflection point and took a sharp turn north in terms of what's perceived as access to IO therapy for a greater number of patients. We've become very accustomed to those tumors that traditionally respond to immunotherapy, notably the hot tumors, which seem to get larger and larger numbers of options within the immuno-oncology field. Those cold tumors that have historically not responded to the commercially available drugs and therefore somewhat suffer from the lack of durability of responses, we're now seeing that evolve and change with the data that we've presented here. I think an impact that has been carried forward.
Perhaps the biggest element has been the absence of investigational therapies, drugs that can break through that glass ceiling that has been established and has limited perhaps our vision of what we need to do to transform care in the diseases that have not previously adopted the standardized use of immuno-oncology drugs. When we look at things like microsatellite stable colorectal cancer, we see the fact that we are now across the spectrum from advanced disease to early disease, identifying robust activity, which I believe will ultimately chart a course for immuno-oncology drugs to potentially overcome those barriers that have been established by what I think we're going to show are misperceptions of the response of these types of cancers to immunotherapy. The same is true for classical ovarian cancer, as opposed to subgroups that tend to respond to immunotherapy.
Of course, sarcomas, while a broad range of diseases, have subgroups for which IO therapy is approved or endorsed. We're beginning to see a more robust activity in diseases that had not been contemplated in that area. I think that the data that we're presenting with bot and bal is going to be intriguing and will open doors. The hard question and the challenge, as you well know in drug development, is are there people, are there companies courageous enough to step through those doors and push through with those unique opportunities to transform our understanding, in this case, of perhaps IO refractory or cold tumors? The critical takeaways from our messaging, traditionally, cold tumors respond to bot bal with the robustness and durability seen historically with hot tumors getting classical immuno-oncology drugs. Response rates, durations of response, and durability of response mirror those seen in prior studies.
The adverse events are limited predominantly to GI issues, such as colitis. We believe that the aggressive management with short-course steroids and early use of TNF-alpha agents will be able to overcome that toxicity and allow patients to, as best as possible, stay on schedule. We believe that patients with or without liver metastases both respond, though the patients without unquestionably have higher response rates. Critically, those patients who have progressed on prior IO therapy similarly have reproducible responses to BOT/BAL, demonstrating that this combination regimen may be able to overcome the failure of classical or historical IO therapies. We're excited about turning a new page in IO treatment and having BOT/BAL be the leader or a leading opportunity to transform the care that we deliver. Thank you very much.
Thank you for all of that. This exciting data presented by Dr. Gordon, of course, we thank him for this and the rest of the investigators, as well as the patient volunteers that contributed to this study, a very large study, I might add. As enthusiasm grows about BOT/BAL, the enthusiasm, particularly at this ESMO meeting, was palpable. That's because both the data, as well as the fact that the French authorities, and I'll talk about that in just a little bit, approved reimbursement and the use of BOT/BAL in France for colorectal patients, advanced colorectal patients. This is the first validation that we've gotten. The data generated and shared at leading international conferences so far have excited people. We're also encouraged by the global recognition, as I mentioned, affirming international confidence for the potential of BOT/BAL.
We had nearly 80 meetings in Paris, as well as at ESMO in Berlin. There was unanimous excitement about the prospects for treating patients with BOT/BAL. Last month, the French National Agency of Medicines and Health Product Safety granted compassionate access, known as AAC, to BOT/BAL for patients with refractory metastatic microsatellite stable colorectal cancer, which is about 90% plus of the colorectal cancer patients. It's the biggest chunk of colorectal cancer that is scaring people these days. The French authorization came in for patients that have exhausted all available options. The inclusion of two investigational agents, including bot and bal, is an extremely uncommon phenomenon and is a tremendous endorsement from, in this particular case, the French ANSM. This agency is one of the most sophisticated, not just in oncology, but particularly immuno-oncology, on the available data and the unmet need, which was the driver of this decision.
Agenus has already supported patient access programs for BOT/BAL through various investigational access programs in France, the United States, and other geographies around the world. Some of the stories from those patients are remarkable stories. We will be sharing them, when we can, with you, as we have in the past. This recent announcement from the French National Agency of Medicines is very meaningful because France will fully reimburse treatment with BOT/BAL for their citizens. This is a very, very important pivotal point. It is a very important inflection point for us that these patients have refractory MSS in colorectal cancer and have no other options left. This is the right thing to do because with patients that have no other viable options left, the data presented on BOT/BAL is quite compelling.
French patients pay nothing for this program, and the hospitals pay nothing because the government fully reimburses for the cost of BOT/BAL. Agenus is committed to making access to our investigational medicines available to patients with cancers at appropriate times and in the correct manner, as we have done in the past. If you are a patient outside of France, please visit our website for programs that may be able to help you. Our website has a growing wealth of information on how patients may be helped. Last week, we were, as I said, in Europe, meeting with more than 80 oncologists from France and across the globe. Over the course of these meetings, it became clear that physicians on both sides of the Atlantic want more choices for their patients. It is very important.
Having choices for patients that have exhausted all other treatments or patients that have actually been confronted with horrible toxicity, mutilating surgeries, having them be presented with options is important for physicians as well as for patients. For example, one of the doctors we met last week in France, Dr. Claire Gallois, has treated six patients through appropriate access programs with BOT/BAL and is now initiating a treatment for her seventh patient. The stories we are hearing about these patients, her patients, and others, align with those that are palpable to us through publications that we have seen on BOT/BAL, as well as in conferences that we've attended. We look forward to sharing more about these experiences as appropriate in the future.
The French AAC program will not only allow Agenus to help more patients, it will also provide access to more real-world evidence, which will support the next steps towards gaining full approval for BOT/BAL. This is part of the program that is required in France, and we have made arrangements with the appropriate outside agencies to collect this data. France has been at the forefront of cancer research, as I've said before, and this goes on for many decades. In many ways, French science and medicine is the gold standard for the rest of Europe. As countries see more of their citizens turning to France for treatment, the questions will become unavoidable. Why aren't we doing the same thing in other countries? Patients in the U.S. will ask, why is this available to French patients and not to me?
Of course, physicians and researchers in America will also ask, why is France leading the way and not America? This is a very testy question. We will work with the appropriate agencies in the U.S. to try to answer this in an appropriate way. Last week, I also had the pleasure of speaking to one of the legends in the field, Professor Alexander Eggermont, who was a pioneer in the field of immuno-oncology. Andy, if we can go to that segment of the video now. Now we're joined by Professor Alexander Eggermont, Professor of Clinical and Translational Immunotherapy in France. Professor Eggermont serves as Scientific Director of the Princess Máxima Center for Pediatric Oncology and holds the Joseph Mason Honorary Chair of Oncological Surgery at Lausanne. Importantly, he previously served as Director General of the prestigious Gustave Roussy Cancer Institute and taught oncology at the University of Paris-Saclay.
Recently, the French system under Access Compassionnel, AAC, a national framework administered by ANSM, which is the French National Agency for Regulatory Affairs, under AAC hospital use is now covering 100% of the cost associated with the use of BOT/BAL. To start with, it's in refractory colorectal cancer. France is the first country to validate the use of BOT/BAL in this context, ahead of the U.S., where the product was discovered and developed for the most part. What is the significance of this? How do you see this affecting the future of access to effective oncology drugs?
The importance of this step cannot be underestimated because it is a program that identifies drugs that are still not approved by FDA or EMA, but that show very clear signals of exceptional efficacy. It's really a pleasure to see that there is a government-supported early access program for those drugs and make them already available, therefore also speed up all sorts of study possibilities and create an environment where we can move fast and faster in patients who may have seen second, third, fourth lines of treatment and with very difficult tumors, like MSS garden variety colorectal cancer, after three, four lines of treatment.
I applaud this initiative greatly. I think it's actually a very good decision to recognize that with botensilimab, you have an exceptional anti-CTLA4, exceptional in terms of capability to prime T cells, to activate antigen-presenting cells, to deplete T regulatory cells at the tumor site. Because of this point mutation, you don't have activation of the complement system, which greatly reduces the autoimmune side effects that we know so well of your regular anti-CTLA4. Therefore, it's an exceptional next-generation anti-CTLA4. Now it emerges as an agent that, with far less side effects, has much more efficacy, even in the metastatic setting.
This is a clear case where not only the regulatory agency in France has reviewed the data, but they're basically putting their own money, the government's money, where their mouth is in terms of endorsing the use of the product in patients. What does this mean for the French patients?
What you will see, obviously, is that the French patients will benefit from this greatly because they have access to a unique combo with efficacy across multiple tumor types, of which colorectal cancer is a very important one and a very frequent one. Therefore, it will start ringing bells elsewhere because I would predict that many European countries will follow this example because we have many discussions about equal access in Europe. Now that France has taken the lead with this program, it puts a lot of pressure on all those countries. The French government got very good advice from a very vibrant immuno-oncology culture in France. For once, they were not defensive, but they were exploratory, and they were willing to give, through their regulation now, these types of drugs an early chance.
How does the French approval under the AAC program impact the credibility of the enormous work that has been done, having treated 1,200 patients with BOT/BAL? What does it mean that the French government, the French regulatory system, made this provision as an endorsement of the efficacy? Of course, the French government, Alex, cannot make a decision for the approval of any agent because of the EMA. This is as close to an approval as we can get with the endorsement of a credible, thoughtful regulatory body. From your perspective, what does this mean for the typical oncologist to have this endorsement?
The oncologists, more and more, will realize their opportunity to offer a treatment which otherwise would still take a while to be approved in indication A, B, C. They will recognize and experience the extraordinary effect of your anti-CTLA4 bot as a driver, as a changer, as an immunosuppressive mechanism suppressor, and as a further structurizing agent, and discover that in the tumors that we thought nothing would help anymore, in third, fourth line, et cetera, et cetera, there is still significant activity to be explored and observed in patient percentages that matter, with a durability effect that matters.
I cannot suppress my enthusiasm. I have to give testimony of my enthusiasm, how game-changing this program can be, not just for France, but for many other countries. It will greatly lead to further advances and acceleration of not just discovering, but also leading to sufficient numbers of success rates that will lead to approvals on both sides of the ocean, of course, by FDA, by EMA. I applaud, really, Agenus, and I applaud the French oncology community for this early access program. I think it's fantastic.
Professor Alexander Eggermont was one of the very early visionaries whose idea for immuno-oncology was testing it in the earlier stages of patients, namely neoadjuvant patients before they went into surgery. I've learned a great deal from his vision because he was a first-comer to this idea. He continues to lead the way. Now, as we accumulate more data and find appropriate ways to enable access for more patients globally, we're clearly building the momentum to bring BOT/BAL to patients who are waiting for alternatives to chemo, radiation, and surgery. We just heard some fantastically positive news from one of our centers with an investigator who was doing a trial with BOT/BAL in patients who are candidates for chemo and surgery.
Because of the efficacy, or I should say, responses that this clinician is seeing, she is submitting a change in the protocol to exclude potentially chemo in patients who are showing profound responses. When you see developments like that, it excites you because our many years of effort in advancing immuno-oncology is now starting to bear fruit for the purposes of improving quality of care and outcomes for patients. With that, my team and I would be happy to take questions. This will happen through Stefanie Nacar, who has done a fantastic job of moderating questions in our last session. Stefanie?
Great. Thank you so much, Garo. Thank you for all that attended the call today. Please be sure to submit any questions or comments directly at ask@agenusbio.com. As questions are coming in, we did receive some questions. The first question, I will pitch this over to Dr. Goldberg, as there's a question about the phase two study. When can we anticipate additional efficacy data, particularly some of the secondary endpoints and overall survival being presented and being available?
We have more mature data in the phase one study than we do in the phase two. We are expecting to get follow-up data for two-year overall survival from the last few patients that were enrolled in the phase two study in the next few months. Once we've had an opportunity to reflect on that data and put it in perspective, we'll be communicating that to the academic world, to the treatment world, and to the investment world.
Great. Thank you so much for that, Dr. Goldberg. Garo, here's a question for you, because certainly the company was very excited about an announcement back in June that we made about a collaboration and a partnership with Zydus Lifesciences. There's a couple of steps to that process in closing that, both related to the manufacturing center out in California, as well as other elements that really enable BOT/BAL to be studied and brought to market in India and Sri Lanka. Can you give an update related to where does that stand and where are we within the process of actually closing out that particular deal?
It is a delight to answer that question in the following way. As Stefanie mentioned, this deal was signed several months ago. The milestones that we've achieved is essentially every step other than what is called a CFIUS review, which is a review that ensures that a transaction with a foreign company does not jeopardize any national security issues. Of course, we don't think that what we're doing in our efforts to cure cancer patients does jeopardize. It is a process that we need to go through. The other step was what's known as Hart-Scott-Rodino, which I'm delighted to tell you again that has been cleared. The only step that we're waiting for is CFIUS. To make matters a little bit more complicated, we had the government shut down because of the disagreement about the budget several weeks ago. That got in the way.
I'm hopeful that in the next few weeks, that will be resolved. In the meantime, certain elements of the government are still functioning. We have submitted the data that they required. They need to formally accept that. Post the formal acceptance, the decision will be made about CFIUS. I'm hopeful that this will get done in the next weeks to a few months. It will be over with. In the meantime, Zydus Lifesciences was very, very gracious to extend us a loan to take some of the pressure off the expenditures from the facility that they will be purchasing. That has been transacted. Some of the pressure associated with those payments from our West Coast efforts is now borne by that loan. We are making progress.
Great. Thank you so much, Garo, for that further clarification. I know it's kind of a unique situation, the CFIUS review, that is a little bit newer, given where the partnership is and those organizations. I think it's very helpful. While we have you up, there was another question. You had made a comment a little bit earlier within the discussion about one of the protocols changing and then potentially eliminating chemotherapy as an option. There was a question if you could just clarify a little bit more what cancer and as well as what setting that was in, just for further clarification.
I don't want to lead too much because we don't want to take the wind off the investigator, who is very excited about this outcome. It'd be inappropriate for me to provide more details because I know that our audience is very smart. Particularly with AI in operation these days, they can type in a few lines and identify the study and the investigator and would like to make sure that we don't violate the confidence of the investigator.
Great. Okay. More to come very soon and very quickly, I anticipate.
Correct.
Wonderful. There's a question that was posted as well in our last webcast that we had back at the end of August. We had Dr. DeVito on the line to talk a little bit about his study, the BB-APCO. The question is, when do we expect to hear more about progress on that study? That study was actually in frontline colorectal cancer, not in the neoadjuvant setting. Perhaps, I don't know if Dr. Goldberg, you, or Dr. O'Day, just from conversations that you've had with Dr. DeVito, if you know when he expects or anticipates to present some of that data at any upcoming conferences.
Stephanie, maybe I can jump in there. Yes, that study continues to accrue and has a lot of excitement around it from patient advocates, patients, and other clinicians. We expect those results to be presented sometime in 2026. The exact timing will depend on the maturity of the data.
Great. I know that we're all looking forward to seeing that. We'll be sure to notify everybody when we hear about when he plans on presenting that data, for sure. This next question actually is going to be for you, Robin. Given all the excitement and the availability of BOT/BAL through the French AAC program, there was a question here about what are we charging, as this is a reimbursed situation within France. Can you explain a little bit about what that looks like and how it potentially could or will not impact future commercialization in Europe?
Sure. Thanks, Stefanie. We've not disclosed the explicit pricing publicly. What I can say is that we have a price in France that is consistent with basically our ability to both price and ensure market access in the future in Europe, not only in France, but across other countries in Europe as well.
Great. OK. Thank you for that. Another question that we have here, which I know that people were very excited about on our last webcast, we had Chris O'Callaghan from the CCTG Group. That is really our collaborating partner of our phase three Batman study in Canada. We are doing a lot of work, and the team is working diligently to initiate that study and open that study as quickly as possible. Dr. Goldberg, can you provide some updates on when do we anticipate that starting or when do we anticipate potentially patients being able to consent or begin enrollment within the study?
I have some exciting news about that. Working with the Canadian Cancer Trials Group has been a real pleasure because they are incredibly responsive and have put our need to get this going first. The study has now been approved by the Canadian authorities. It has actually been approved by IRBs in three of the larger provinces in Canada. The drug availability has been worked out. You have all these details that you have to manage, like labeling and shipping the drug. That has all been taken care of. We had our first investigator meeting at ESMO with attendees from the three continents where the study will be done: Canada, France, Australia, and New Zealand. We fully expect the first patient to be enrolled in November, latest December of this year.
Great. More to come. We'll be sure to make that announcement when we reach that milestone as well. We're very excited about patients globally being able to participate and volunteer in the study and get access to BOT/BAL as well. The next question here, Dr. O'Day, there's been a lot of focus, particularly on colorectal cancer, as we understand, is the most advanced tumor type for our program. With the data that was just presented at ESMO in the pan-tumor setting, we're also getting some questions related to any updates on pancreatic cancer data, as well as anything else related in RCC.
So pancreas and RCC , there were patients in the large phase one study, a small number of patients on those. We have not reported any phase two data yet in pancreas or renal cell carcinoma. Those studies are ongoing. What I will say is really bringing back to heart what Dr. Michael Gordon, the presenter at the European Society for Medical Oncology, for the 400-patient pan-tumor phase one, what's really remarkable about this study is it really points to the mechanism of action of bot and how it's been designed to prime better, to deplete T cells, T regulatory cells, and to reactivate and repolarize the microenvironment. This very important foundation of botensilimab has made it an agnostic target in the sense that it's immune T cells and other immune cells that affect the microenvironment. What we saw with over 400 patients was compelling and consistent data.
Mike spoke to this, as well as Alex Eggermont, with response rates that are deep and durable and survival rates at two years of essentially 40%, with emerging plateaus beyond that. This has not been produced before in cold or poorly immunogenic or even immuno-oncology refractory tumors and even liver metastases. These themes are what are propelling doctors across the continents that there is a differentiated CTLA-4 that, paired with an effective PD-1, is really expanding the reach. That's the excitement that's been generated.
Great. Thank you so much, Stephen. I have another question here as they keep coming in. Please continue to submit your questions to ask@agenusbio.com. Dr. Goldberg, we just spoke a little bit about the excitement around the Batman initiation. Certainly, with data that was presented at ESMO, there is a question that has come in related to data in MSS colorectal cancer from the STELLAR 303 study versus the non-liver met dataset. I know it's been really just moments, and the team necessarily probably hasn't had a chance to completely debrief. Would love to have your perspectives on that and do you see it informing any probability of success for our Batman study? That was the first part of the question that was submitted.
It is not really our place to comment on the efficacy of another company's trial. There are plenty of talking heads out there that are busy commenting. You can find those on the internet, as well as you can listen to the commentary by the person that reviewed the abstract and presentation at ESMO. What this does for us is to feed our enthusiasm about having a phase three trial compared to best supportive care in the fourth-line setting in colorectal cancer with two IO drugs, a primer and an effector. We believe that that synergistic combination is uniquely effective and that bot is uniquely effective compared to competitor drugs. Stay tuned. Batman will be accruing shortly, and we hope to have data to support our enthusiasm within the next several years.
Thank you, Dr. Goldberg. I actually have another follow-up question to you. I know that as questions come in, we are kind of bouncing around a little bit between disease settings and different lines of treatment, given the broadness of our clinical studies that are ongoing either through the company itself or through investigator-sponsored trials. This question here is, what are our thoughts on any late-stage development in the neoadjuvant setting? Certainly, there's a lot of data that's been presented from the UNICORN study and the NEST study at ASCO GI last January, as well as NEOASIS study in pan-tumor neoadjuvant setting. Can you share a little bit more about the guidance or the development path for neoadjuvant in rectal or colorectal cancer?
We believe that BOT/BAL will be used to best advantage in early-stage disease. The notion that we could avoid chemotherapy, radiation, and extensive surgeries in patients is very attractive to patients and to their physicians. We are seeing dramatic improvements in tumors that are treated with just three doses, one botensilimab and two balstilimab. Patients have been taken to surgery, and many of them have had complete responses. Some of this data has been presented at AACR and at the ASCO GI symposium. The data is still being collected, and patients are still being enrolled. We are expanding our enrollment to include MSS rectal cancer patients. We are in the process of putting together a clinical trial in the neoadjuvant setting in colon cancer, which we will be requesting FDA commentary on once the government is open and they're back in business.
Great. Thank you so much. I think we have maybe a moment for one last question. Robin, this question will be for you. Given the French AAC program was just announced a short while ago, is there anything that you could share today? I know that there's a lot of administrative processes and things to put into place before patients can be receiving BOT/BAL in France through the AAC program. If there's anything to share about any uptake or any current interest or what we anticipate, that would be fantastic.
Sure. One of the things I can share is that we have already received an order for BOT/BAL through the paid AAC program. One comment is that remember, this is compassionate access. The physicians who are requesting access for their patients in France request access. It has to be approved by ANSM, and the patients have to be also approved in terms of their medical eligibility by Agenus, by our clinical team. This is a program that is open to all of the patients who are under the French health care system. It is, I think, very encouraging that it is reimbursed by the government of France. I think this is a very unique program. It's great to see how progressive France is in ensuring access for patients early on when they see that there is a positive clinical benefit for patients based on their assessment of the data. Those are the only programs from which they will grant compassionate access.
Great. All right. Stay tuned. More to come. We're actually a little bit over our dedicated time, and there are still some questions that we were not able to answer. We will be sure to collate those and make sure that we address them during our next webcast or our next engagement with you all. With that, I want to thank all of the viewers for attending today and for all of your questions and for Dr. Garo H. Armen, as well as Dr. Michael Gordon and Dr. Richard Goldberg for their participation. I know that they wanted to be here live, but due to ESMO engagements and responsibilities and the time difference, they were unable to do that in person. We thank them for taking the time to share with us their thoughts in advance, and we look forward to sharing more with you all on our next webcast.
Thanks for joining.
Thank you.