Agenus Inc. (AGEN) Earnings Call Transcript & Summary

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. But 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 2 internationally known leaders in the field of oncology and immuno-oncology 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's 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 Development Officer; and Robin Taylor, our Chief Commercial Officer, will join Garo for a live Q&A. For the listeners that have joined for us today, please submit your questions to the e-mail [email protected]. And we'll be sure to share that again at the end of the discussion to make sure that you guys engage and submit your questions. With that, I would like to introduce Agenus Founder, Chairman and CEO, Dr. Garo Armen.

That's okay. Some people call me Garmin, Stefanie. Hello to everyone once again. At today's briefing, we will discuss 2 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 9 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 significant burden of disease before surgery, and 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, and those constitute the great majority of cancer patients. And 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 I study which, by the way, when you say Phase I, this is one of the largest Phase I studies ever because we have nearly 1,000 patients in just the Phase I cohort of our studies. Dr. Michael Gordon of HonorHealth Research in Scottsdale, Arizona, presented the data. And of course, this was in front of a substantial audience. And I was able to connect with Dr. Gordon before his presentation at ESMO for a brief discussion about the data. And let's now turn Andy to that discussion that was taped with Dr. Gordon. [Presentation]

Thank you very much for joining us, Mike, here. Dr. Gordon is an extraordinarily experienced and talented investigator treating physician. And 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. And 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. And all of a sudden, of course, 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 and 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. Now you mentioned some very important points here. The first-generation IO compounds have been sort of impacting the low-hanging fruit, which we would term as immunologically active tumors. And now this is the next wave presumably, and 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. But 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. And 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. So 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. And of course, sarcomas, while a broad range of diseases have subgroups for which IO therapy is approved or endorsed, but we're beginning to see a more robust activity in diseases that had not been contemplated in that area. So I think that the data that we're presenting with BAT 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, and 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. And 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. So 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 and the enthusiasm, particularly at this ESMO meeting was palpable. And 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. And this is the first validation that we've gotten. So 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, and there was unanimous excitement about the prospects for treating patients with BOT/BAL. Now last month, the French National Agency of Medicines and Health Products 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. So it's the biggest chunk of colorectal cancer that is scaring people these days. Now the French authorization came in for patients that have exhausted all available options. The inclusion of 2 investigational agents, including BOT and BAL is an extremely uncommon phenomenon and is a tremendous endorsement from, in this particular case, the French ANSM. And this, by the way, agency is one of the most sophisticated, not just in oncology, but in 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 and we will be sharing them when we can with you as we have in the past. But this recent announcement from French National Agency of Medicines is very meaningful because France will fully reimburse treatment with BOT/BAL for their citizens. And of course, this is a very, very important pivotal point, and it's a very important inflection point for us that have -- these patients have refractory MSS in CRC and have no other options left. And of course, 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. And 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 6 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. And of course, 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 medicines 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 United States 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 French leading the way and not America? Of course, this is a very testy question, and 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, Dr. Alexander Eggermont, who was a pioneer in the field of immuno-oncology. And Andy, if we can go to that segment of the video now. [Presentation]

And now we're joined by Professor Alexander Eggermont, Professor of Immunology, University of Medical Center in Utrecht. Professor Eggermont serves as Scientific Director of the Princess Máxima Center for Pediatric Oncology and holds the Joseph Maisin Honorary Chair of Oncological Surgery at Leuven. And importantly, he previously served as Director General of the prestigious Francis Gustave Roussy Cancer Institute and [indiscernible] Oncology at the University of Paris-Saclay. Recently, the French system under Accès Compassionnel AAC, a national framework administered by NS or 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 colon 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? And 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. And so it's really a pleasure to see that there is a government-supported early access program for those drugs and make them already available and 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 3, 4 lines of treatment. So I applaud this initiative greatly. And I think it's actually a very good decision to recognize that with botensilimab, you have an exceptional anti-CTLA-4, exceptional in terms of capability to prime T cells to activate antigen-presenting cells to deplete T regulatory cells at the tumor side. And 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-CTLA-4 and therefore, it's an exceptional next-generation anti-CTLA-4. And therefore, 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?

So 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. And 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. And 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. And for once, they were not defensive, but they were exploratory and they were willing to give through their regulation now these type 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 French government -- French regulatory system made this provision as an endorsement of the efficacy. Of course, the French government elects cannot make a decision for the approval of any agent because of the EMA. But this is as close to an approval as we can get with the endorsement of a credible thoughtful regulatory body. So from your perspective, what does this mean for the typical oncologists to have this endorsement?

The oncologists more and more will realize their opportunity to offer a treatment, which otherwise would still take a while, right, to be approved in indication A, B, C. They will recognize and experience the extraordinary effect of your anti-CTLA-4 BOT as a driver, as a changer, as an immunosuppressive mechanism suppressor and as a further structurizing agent and discovered that in the tumors that we thought nothing would help anymore, right, 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. Yes, I cannot suppress my enthusiasm. I have to test -- I have to give testimony of my enthusiasm how game-changing this program can be, not just for France, but for many other countries. And 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. So I applaud really ANCA and I applaud the French oncology community for this early access program. I think it's fantastic.

So Professor 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. And I've learned a great deal from his vision because he was a first comer to this idea, and 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. And 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. And 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. And with that, my team and I would be happy to take questions, and 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, and thank you for all that attended the call today. Please be sure to submit any questions or comments directly at [email protected]. So with that, 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 II study. And when can we anticipate additional efficacy data, particularly some of the secondary endpoints and like overall survival being presented and being available.

So we have more mature data in the Phase I study than we do in the Phase II. But we are expecting to get follow-up data for 2-year overall survival from the last few patients that were enrolled in the Phase II 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. And 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?

Well, it's a -- you'd like to answer that question in the following way. As Stefanie mentioned, this deal was signed several months ago. And the milestones that we have 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. And of course, we don't think that what we're doing in our efforts to cure cancer patients does jeopardize, but it's a process that we need to go through. And the other step was what's known as Hart-Scott-Rodino, which I'm delighted to tell you again that has been cleared. So the only step that we're waiting for is CFIUS. Now to make matters a little bit more complicated, we had the government shutdown because of the disagreement about the budget several weeks ago and that got in the way. But I'm hopeful that in the next few weeks, that will be resolved. But 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. And post the formal acceptance, the decision will be made about CFIUS. So I'm hopeful that this will get done in the next weeks to a few months, and it will be over with. But in the meantime, Zydus was very, very gracious to extend us a long to take some of the pressure off the expenditures from the facility that they will be purchasing. And that has been transacted. And so some of the pressure associated with those payments from our West Coast efforts is now borne by that loan. And so we're making progress.

Thank you so much, Garo, for that further clarification. I know it's kind of a unique situation on the CFIUS review that is a little bit newer given where the partnership is and those organizations. So I think it's very helpful. While we have you up there, 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.

So I don't want to lead too much because we don't want to take the wind of the investigator who is very excited about this outcome. And it'd be inappropriate for me to provide more details because I know that our audience is very smart and 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.

Okay. So more to come very soon and very quickly, I anticipate. Wonderful. So 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-OPCO. The question is, when do we expect to hear more about progress on that study? And that study was actually in frontline colorectal cancer, not in the neoadjuvant setting. But 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.

So Stefanie, 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. And 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. So 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, Rob. Given all the excitement and the availability of BOT/BAL through the French AAC program, there was a question here about what is -- what are we charging as this is a reimbursed situation within French -- 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. But 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. Okay. 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 III BATTMAN 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?

So I have some exciting news about that. Working with the Canadian Clinical Trials Group has been a real pleasure because they are incredibly responsive and have put our need to get this going first. So the study has now been approved by the Canadian authorities. It has actually been approved by IRBs in 3 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. So that has all been taken care of. We had our first investigator meeting at ESMO with attendees from the 3 continents where the study will be done, Canada, France and Australia, New Zealand. And we fully expect the first patient to be enrolled in November, latest December of this year.

Great. So more to come. We'll be sure to make that announcement when we reach that milestone as well. So we're very excited about patients globally being able to participate in volunteer in the study and get access to BOT/BAL as well. So 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. But 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 I trial, a small number of patients on those. We have not reported any Phase II data yet in pancreas or RCC, but those studies are ongoing. But what I will say is really bringing back to heart what Mike Gordon, the presenter at ESMO for the 400-patient pan-tumor Phase I. 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-cell -- 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. And really, what we saw with over 400 patients was compelling and consistent data. Mike spoke to this as well as [ zalifrelimab ] with response rates that are deep and durable and survival rates at 2 years of essentially 40% with emerging plateaus beyond that. This has been not produced before in cold or poorly immunogenic or even IO refractory tumors and even liver metastasis. So 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, and that's the excitement that's been generated.

Great. Thank you so much, Steven. I have another question here as they keep coming in. So please continue to submit your questions to [email protected]. And Dr. Goldberg, we just spoke a little bit about the excitement around the BATTMAN initiation. Certainly, with data that was presented at ESMO, there is a question that has come in related to data in MSS CRC from the STELLAR-303 study versus the non-liver met data set. I know it's been really just moments and the team necessarily probably hasn't had a chance to completely debrief, but would love to have your perspectives on that? And do you see it informing any probability of success for our BATTMAN study? So that was the first part of the question that was submitted.

So it's 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 and 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 III trial compared to best supportive care in the fourth-line setting in colorectal cancer with 2 IO drugs, a primer and an effector. And we believe that, that synergistic combination is uniquely effective and that BOT is uniquely effective compared to competitor drugs. Stay tuned. BATTMAN 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. But 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 the 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?

So we believe that BOT/BAL will be used to best advantage in early-stage disease. And 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 3 doses, 1 BOT and 2 BAL and then patients have been taken to surgery and many of them have had complete responses. Some of this data has been presented at AACR at the ASCO GI Symposium. The data is still being collected. Patients are still being enrolled, but we are expanding our enrollment to include MSS rectal cancer patients. And 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. And I think we have maybe a moment for one last question. And Robin, this question will be for you. Given the French AAC program was just announced just a short while ago. But is there anything that you could share to date? I know that there's a lot of administrative processes right and things to put into place before patients can be receiving BOT/BAL in France through the AAC program. But if there's anything to share about any uptake or any current interest or what we anticipate, that would be fantastic.

Sure. Well, one of the things I can share is that we have already received 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 has to be approved by ANSM. And then the patients have to be also approved in terms of their medical eligibility by Agenus by our clinical team. So 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. And 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. And that's -- those are the only programs from which they will grant Compassionate Access.

All right. Stay tuned, more to come. So we are actually a little bit over our dedicated time, and there's 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. So with that, I want to thank all the viewers for attending today and for all of your questions and for Dr. Armen as well as Dr. Gordon and Dr. Eggermont 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. So 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. So thanks for joining.

Thank you.