Garo Armen

Chairman & Chief Executive Officer (also interim CFO/Principal Financial Officer as of early 2026), Agenus Inc.

Agenus December 2025 Stakeholder Engagement Webcast

🎥 Dec 04, 2025 📺 Agenus Bio ⏱ 78m 👁 493 views

Join us for Agenus’ End-of-Year 2025 Webcast featuring leading GI oncologists and a powerful caregiver-physician story that brings the BOT/BAL journey to life. Hear how immunotherapy expectations in MSS colorectal cancer are shifting, get an inside look at the global Phase 3 BATTMAN trial, and learn how innovative approaches may change the path forward for patients. Featuring: • Dr. Christopher Lieu — evolving role of IO in CRC • Dr. Jonathan Loree — Phase 3 global trial momentum • Dr. Benny Johnson — a personal early-onset CRC journey and clinical-trial decision-making Moderated by Garo Arm...

Watch on YouTube

About Garo Armen

Garo Armen, chairman and chief executive officer of Agenus, participated in a company conference call on July 13, 2026, regarding financing and the ROBBIN trial strategy. During the call, he introduced two guest investigators, Professor Miriam Chilapi and Dr. Christi, who discussed neo-adjuvant immunotherapy approaches for colon cancer. Armen also addressed questions about the French AAC program, stating that the company is collecting real-world outcome data under the program's guidance.

Source: AI-verified profile updated from Garo Armen's recent appearances. Browse all interviews →

Transcript (89 segments)

Stephanie0:00

Welcome to the May 25 stakeholder webcast where we bring together scientific leaders, clinicians, and patient voices to discuss the progress and global momentum surrounding the botbal immunotherapy program. Before we begin, a quick reminder that today's discussion will include forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ. Please refer to our SEC filings for more detail.

Today's session brings together three distinguished guests offering scientific depth, clinical insight, and lived experiences in colorectal cancer. First, we'll hear from Dr. Christopher Lou, professor of medicine at the University of Colorado Cancer Center, where he'll discuss the evolving role of immuno-oncology in colorectal cancer, particularly in MSS disease, and he'll also share a remarkable case from his practice that demonstrates the potential of deep and durable responses.

Then we'll have Dr. Jonathan Laurie, medical oncologist, associate professor at the University of British Columbia, and a senior investigator with the Canadian Cancer Trials Group. He will provide an operational update on the global phase 3 BATMAN trial, including rapid site engagement, broad international enthusiasm, and key drivers and trial momentum heading into 2026.

And finally, Dr. Benny Johnson, senior medical director at Agenus and former GI oncologist at MD Anderson Cancer Center, will share his family's personal experience navigating early onset colorectal cancer—a journey that shapes his dual perspective as both a clinician and a caregiver.

Following these discussions, Agenus leadership including Dr. Steven O'Day, our chief medical officer, and Dr. Richard Goldberg, chief development officer, along with Benny Johnson, senior medical director, will join Gar for a live Q&A. As there were some presubmitted questions related to biomarker development, Dan Chan, our VP of research, will also join for the Q&A as well. Questions may be submitted at any time to the email [email protected]. So, thank you again for joining us today. And with that, I'm pleased to introduce our founder, chairman, and CEO, Dr. Garo Armen.

Garo Armen2:30

Thank you very much, Stephanie, and thank you all of you for joining us today. Based on our previous experience, we have patients, caregivers, advocates, clinicians, regulators, policy leaders, as well as investors, and everyone else who is committed to advancing the future of cancer care.

Now, we've decided to have these sessions with some frequency for two very clear purposes. Number one, we want to make sure that we keep you abreast of the latest developments concerning botbal particularly, but also concerning the company. And secondly, we would like you to hear the points of views of a broad range of experts in the field. And that's what we've done in the last three sessions and that's what we will continue to do with frequency in the future. And so these are not quarterly meetings but these are meetings that will be presented to you with a higher level of frequency.

In 2025, the botbal program reached a number of important inflection points. Clinical data now span more than 1,200 patients treated across nine tumor types from the most refractory settings to earlier localized disease. These findings continue to reinforce the fact that a clear trend is emerging in a significant number of patients.

Immunotherapy may hold far more potential, including particularly cold tumors, than previously believed, and this has surprised a number of experts, but the data is clear. MSS colorectal cancer is among the clearest examples of this. For years, this disease was considered largely unresponsive to immunotherapy. By the way, when we talk about MSS colorectal cancer, this accounts for well over 90% of colorectal cancer patients in the US and across the world. So this is the substantial chunk of colorectal cancer patients.

But this past year has brought forward new signals with our experience certainly in both refractory and earlier stage settings. As I mentioned before, we're seeing meaningful responses and these are durable responses, and we're seeing them consistently across multiple centers around the world. And of course, one of the concerns is that if your data is only from one or two centers, perhaps there's the risk of cherry-picking. But we are now talking about dozens of centers in three different continents.

These findings clearly challenge the long-held assumption, and that opens the door to new possibilities for patients with chemorefractory treatment options. For all of us at Agenus, this work is deeply personal. As you'll hear from the interview with Benny Johnson, who is also here live today, every patient and family navigating this disease reminds us that why progress must continue with a high sense of urgency.

Today you'll hear from three leaders, as Stephanie talked about, who reflect the scientific, operational, and human dimensions of this work.

Dr. Lou will share how expectations for immunotherapy in CRC are evolving. Now these expectations were non-existent other than for MSI high tumors, which account for about 5% of all CRC patients. He's going to share a case from his practice with a hepatocellular carcinoma patient, and I'll let him of course describe his experience with this, which is a remarkable outcome.

Dr. Laurie will describe the extraordinary global mobilization behind the phase three BATMAN trial. This is our phase three potentially approvable trial—a level of alignment driven by strength of early stage clinical signals and the urgency felt by investigators worldwide. And of course, Dr. Johnson, our very own Dr. Benny, will offer a deeply personal perspective as both a physician and a caregiver, reminding us that behind every data point is a family, a patient whose life is shaped by the options available to them. And we're very proud of the fact that we're expanding those options, particularly chemorefractory options for them.

As we move into 2026, our priorities are clear. We will expand patient access to botbal, including through France's reimbursed ATU pathway and Agenus's paid named patient program, available in approximately 30 countries that allow self-pay or pay with special insurance that has a patient's ability to access a not yet approved treatment. Number two, we will advance the BATMAN global phase three program with speed and rigor. And number three, expand our neoadjuvant studies that are now beyond CRC where the potential for cure is the greatest.

These efforts are essential if we are to bring meaningful innovation to patients in years, and I hope in some cases it will be in days and months, but not decades. I want to thank you Dr. Lou, Dr. Laurie, and Dr. Johnson for joining us today and for your commitment to patients. So, let's begin our program.

I've been in the oncology space for 31 years, formerly through, but we did not get to know you until botbal. And so you are a very accomplished physician with varied interests. You've been at MD Anderson for your fellowship, I believe, and now you're at the University of Colorado. When I look at your institution's background, it lists everything under the sun for the treatment of cancer—and I'm not talking about your research interest, of course, but the institution—but it doesn't talk about immunotherapy, partly because immunotherapy is relatively new. Why do you think that is? And what is it going to take for us to get around the historical barriers to embrace new treatments? What do you think is the issue with MSS colorectal cancer, which constitutes about 90–95% of the patients today?

Christopher Lou10:12

That's right. You know, MSI high colorectal cancers have gotten a ton of press, which is phenomenal, right? I mean, for that 4 or 5% of patients that are MSI high, to be able to offer them single-agent immunotherapy, or in some cases double immunotherapy, and to have, I think, outstanding outcomes—that is exciting. We see that in the metastatic setting, we see that in the neoadjuvant setting, in the curative setting, particularly with locally advanced rectal cancers. But just like you said, 95 to 96% of our patients with metastatic colorectal cancer will be microsatellite stable, and the issue there is that when we've done studies with pembrolizumab, or nivolumab, or even nivolumab and ipilimumab, in this subset of patients—the 96% of patients that are microsatellite stable—we know that the responses have been virtually zero, for lack of a better term. It's just really not been effective. And the reason why is because when you look at MSI high cancers, the T cells are there—you can even look inside the tumor and there are lymphocytes infiltrating into the tumor. But when you look at microsatellite stable colorectal cancer, it is the perfect definition of an immune desert. There are no T cells. It seems like there's very little upfront immune activation. And so the way I describe it is that for microsatellite stable colorectal cancer, it's like having a dance floor, but nobody's on the dance floor, right? You're just turning up the music louder and louder, but there's nobody dancing because there's nobody there. To use the same analogy, in MSI high colorectal cancer, it's like you have the dance floor and there are a ton of people already there, you just got to start the music. And it really just shows you there's a very, very distinct difference in the tumor microenvironment between the majority of our patients—microsatellite stable—and our patients that have MSI high colorectal cancer.

Garo Armen12:03

What you're seeing in this small group of patients who have MSI high colorectal cancer is nothing short of a miracle, right? So then how do we repeat that miracle?

Christopher Lou12:18

Yeah, I think we were very fortunate at the University of Colorado to be able to be involved early in drug development for botbal. When we initially started the phase one, I think there was some healthy skepticism in terms of what we may or may not see, just based off of the mechanism of action. We just kind of wanted to see, what are some of the responses we're seeing with this combination? And one of the things that really impressed not only me, but our entire team, our entire phase one unit, were some of the responses that we're seeing. And what we are talking about are really kind of two things. Whenever patients have really refractory cancers, you really want to focus on response rates because that's a very, very early endpoint. But our patients just feel better when they have less tumor burden. And so when we are seeing dramatic responses, that's always exciting. Patients are excited, they're feeling better, CT scans are looking better, and you can show them the difference before and after. And we are seeing that with botbal. And then the second thing is the durability of response. It's no fun at all for any patient or any provider to have a response that lasts for 2 months, because 8 weeks after you start a treatment, you're super excited, and then literally 16 weeks after you started treatment, everybody's super, super upset and sad. And so it's response and it's the durability of that response, because if you see that great response to a treatment and it goes on for a really long time, that's the win.

And so when we started seeing that early—early right in the drug development of botbal—it was unbelievably exciting. I had a patient with severely refractory hepatocellular carcinoma, liver cancer. Immunotherapy is actually used up front for the treatment of metastatic liver cancer, HCC. And so this patient was started on atezolizumab and bevacizumab—she didn't respond at all. She started on a second-generation tyrosine kinase inhibitor that targets VEGF, we tried lenvatinib, that didn't work. And by that time she had this mass that was in her abdomen that literally you could feel, and with each subsequent therapy—the immunotherapy, the targeted therapy, even the other phase one clinical trial—we saw continued growth of this tumor. It was causing a ton of pain. She reported continuous 7 out of 10 pain. That's really unacceptable. And we also knew that if this thing is going to continue to grow, eventually it's going to block the bowel, or even potentially protrude out of the skin. And so usually in that case, as oncologists, we're going to recommend hospice, because we expect in the next couple of months that maybe there would be a really, really unfortunate or bad outcome. And I think my patient kind of understood that as well. But she was eligible for botbal. We put her on the phase one, and really, this is the last Hail Mary attempt. We knew if this didn't work, we are absolutely going to send this patient to hospice, where the life expectancy really would be measured in months.

And just after a couple of doses, you could actually feel this thing in her abdomen. Her pain went from a 7 out of 10—after literally 4 weeks, it went to a 0 out of 10. It was unbelievable. Her AFP, alpha-fetoprotein, which is a tumor marker that we measure in the blood—it was literally 200,000. Right? Normal—you don't want that thing to be above single digits. And that had completely normalized after 2 months. One of the most dramatic responses I've ever seen in my entire life. And the thing that was so gratifying about it is the patient—just her pain was gone. When you look at the imaging, all that was left was like this shell, kind of what I assume is just fibrotic or scar tissue. The amazing thing about this patient is that she was going to hospice. Two years later, after being on the botbal study, she came off study because that's protocol, and she hasn't required treatment for her cancer now in over two years. And this really shows you, number one, exactly what we're talking about—response. Patients feel better. Number two, the durability of response. And for all intents and purposes, with a normal AFP, a normal scan, no treatment in a year and a half to two years, we're effectively talking about cure of a disease that would have probably given her only a couple more months to live. Really just one of those things that you'll never forget as a physician. Just an honor to be part of it—a life saved and literally a life cured. And there are stories like this across all investigators that have had experience with botbal.

Garo Armen17:04

Wow. Now, that is a wow. It is nothing short of a miracle to see something like that. And yet when you talk to individual patient case studies with regulators and regulatory experts, the typical response is that it's an anecdotal case. With traditional treatments like chemotherapy, not only often do you require continuous therapy for the patient in order for the response to persist, but you also have to deal with the toxicities associated with traditional treatments. More is sometimes resulting in more responses, but more is also resulting in a lot more toxicity. You know, when you think about chemotherapy side effects, especially if you say, okay, well, chemotherapy is going to decrease white blood cells—you imagine when you stop chemotherapy, that there'll be at least somewhat of a recovery of those counts, because you're taking that kind of poisonous toxicity off the table. One of the things with immunotherapy is that when you activate somebody's immune system, you obviously hope it attacks the tumor—and by golly, it really did in this patient. But you also have immune activation in other areas as well that can cause side effects. For this patient, she actually developed adrenal insufficiency, and that is a known side effect of immunotherapy. So that requires her to take a daily small amount of steroid. And she'll tell you, time over time, that she would trade that a million times over for the cure that she received. But the toxicity—balancing that toxicity and the efficacy of the drug is something that we all do, as investigators, as physicians. And here I would say the trade-off is pretty clear. You're cured. You do have to take this medicine, but it's kind of one of those things where, is it worth it for her? She would tell you that she's just living her best life. And so I don't think that she really has too many long-lasting toxicities besides the fact that she does have to take the medicine.

So, how does a physician like you—who has also served on ODAC, FDA's Oncology Advisory Committee—reconcile all of these anecdotal cases that are miracles for patients?

Christopher Lou19:35

Well, you know, from a regulatory standpoint, it's difficult, right? I mean, the paradigm of how we traditionally look at progression-free survival curves and overall survival curves is really changing in the setting of immunotherapy. And I think the FDA is really trying to maneuver this change from what we typically see with chemotherapy and even targeted therapies, with some of the long-lasting impacts that we see with immunotherapy. And it's not an easy job, because whenever you look at these curves, we know that there are some patients that are just not going to respond at all to these drugs. And then on the flip side, there can be patients like my patient, where that curve is just going to keep going, kind of forever—what we call the tail of the curve. And really, what that means for people who aren't familiar with looking at some of these survival curves—we have to keep in mind that whenever a survival curve drops, those are patients that are passing away from their cancer, and that should be a sobering thing whenever we look at it. But at the same time, when you look at these curves and the drop-off stops, and then there becomes this tail of the curve where people are just continuing to live and live and live—which again suggests either two things: that the disease is under incredible control, or that there's a cure. We, as physicians, as investigators, as patients, even as regulators, are going to have to really determine where that tail of the curve is and what that means for our patients. So, do approvals start to happen because we see that—like, what if 20% of the patients that enroll onto a study are essentially either have durable responses or are cured? Well, that's something that needs to be considered. And there have been treatments that have been approved based off of this long, continuous, either cure rate or durability of response curve.

Garo Armen21:30

How do patients react or even embrace when you explain the prospects of being treated with immunotherapy versus the traditional treatment?

Christopher Lou21:40

Yeah, I think that there's always a lot of excitement from our patients whenever they're offered anything other than chemotherapy. And I think that there is a knowledge that immunotherapy isn't going to work for everybody, but it's the idea that there's a chance of a durable response that I think really gets everybody excited. Again, it's up to us to make sure that we provide access. Number two, make sure that we provide the right clinical setting. But number three, one of the most important things is to really just find out who those amazing responders are and offer those patients the drug, to make sure that if they do experience any side effects, it's well worth it because your response rates are going to be so much higher. We have to identify the patients that are going to have that durable response. And I think that's a lot of the work that's coming up for all of us.

Garo Armen22:27

Well, thank you very much. You probably always do that for your patients, but for your extra time that you've devoted to us this morning, and we will see you soon.

Christopher Lou22:37

Absolutely. Thank you for this opportunity.

Garo Armen22:42

So, we thank Dr. Lou for his very insightful discussion. You experienced with Dr. Lou having served on the FDA Advisory Committee—he has a substantial amount of regulatory experience and the ability to decipher data in ways that other investigators may not have. And Dr. Lou is new to you. We haven't featured him, and we expect that many others in the next months will be here talking about their experience with botbal. His remarks underscore a meaningful shift underway in oncology, as clinicians observe responses in diseases like MSS colorectal cancer—typically unresponsive to not just immunotherapy but poorly responsive to other treatments, particularly in the metastatic setting—and the fact that we have to move very quickly with a high level of urgency. This sentiment is growing. It's increasingly clear that immunotherapy will play a role in this and other disease settings. The question now is how quickly can we bring these advances to patients.

So few people have had a closer view of this momentum than Dr. Jonathan Laurie. Dr. Jonathan Laurie is one of the lead investigators for our CCTG trial that has gotten underway, actually working with the Canadian Cancer Trials Group—that is the full name for CCTG—and partners across Canada, France, Australia, and New Zealand, where the trial is going to be conducted and the patient recruitment is going to take place.

He has helped drive one of the fastest-moving global trial efforts we've seen. His perspective reveals not only the scientific promise but also the operational readiness and enthusiasm from investigators around the world. And let's turn now to that discussion.

Hello John, Dr. Laurie. Thank you very much for being with us today. The first time we met, I believe, was almost 3 years ago at ASCO. You and Chris had come to meet with us, with our team, and you made a very, very strong case as to why CCTG, along with the interest of your colleagues in Canada and elsewhere, would be the best candidates to enroll patients in this trial.

Jonathan Laurie25:38

Yeah, the Canadian Cancer Trials Group had recently finished, at the time, a clinical trial evaluating different immunotherapy compounds—durvalumab and tremelimumab—in a trial called CO26. This was a phase two trial and it was weakly positive, but it wasn't something that moved to a phase three trial. And we thought that this is a population where there is an opportunity for there to be benefit from immunotherapy. But then when we saw the data with botensilimab and balstilimab, it really stood out as something that was exceptional and different. And when we thought about the phase three trial, and something that should move forward in the same population, they really stood out as the agents that would be ideal. We had a strong track record in Canada for that trial, the CO26 trial, and we work very closely with collaborators in Australia, New Zealand, and France in a number of trials across our cooperative groups. And so we've got a strong track record and shared history. We knew that this was something that we were excited about—the science, excited about the possibility of progress for our patients. We had the capacity across our networks and a shared history that we could really do this trial efficiently and do it at a level that was going to be important to move this as something that would evaluate it properly for moving into the clinic.

Garo Armen26:55

Typically in colon cancer, you don't really look at immunotherapy as an option. John, what is the sentiment from the field, your close circle of hospitals and investigators? What are they thinking and what's the level of early receptivity?

Jonathan Laurie27:17

There's been a sense of awe, really, at seeing what immunotherapy can do in microsatellite instability-high colorectal cancer. We've seen just how dramatic that effect can be. But when we see patients in clinic who don't have microsatellite instability-high, we've felt a little bit like we're failing them. People are excited about the possibility of doing that in the 95% of colorectal cancers that are not microsatellite instability-high, and so that's led to a lot of hope and enthusiasm for this to be something that is a new option for patients, and not just an option that's an incremental step, but something that can really make a big impact for our patients.

Garo Armen27:58

John, patients are looking for an option that is different than the traditional toxic options.

Jonathan Laurie28:08

The field is excited about this, and the preliminary data looks really good. I'm excited about the BATMAN trial being something that we're doing in a way that is going to give us the data showing that this combination improves overall survival. And one of the key priorities when working with the Canadian Cancer Trials Group is we're designing this trial also to make sure that not just is it positive from a regulatory perspective, but that when it gets to a health technology assessment, that payers across every country are going to have the data that they need to make their decisions on reimbursement. And I think that's really important. We need to plan for not just the trial now, but also planning to make sure that we have all the data elements that are there and required to make it so it's something that can move into the clinic.

You mentioned the cytotoxic component, and that's really important. Patients, when they're at the point that they would enroll on BATMAN, they've been on cytotoxic chemotherapy for a couple of years and they're getting tired. They've had a lot of the cytotoxic side effects—they build up over time. And having something different, it's a world of difference for what their quality of life means. And it gives them a chance to spend quality time with their loved ones and doing the things that they want to do. And so I think that's also really important—having that different mechanism so that way they can recover from what they've been through.

Garo Armen29:25

And not only do you have to address their needs to have a longer life, but you said a better quality of life.

Jonathan Laurie29:36

Yeah, that's a major, major thing that patients tell me in clinic is that, you know, they want to live longer with their cancer, and they want to live well, and they want to be able to do the things that they used to do before their cancer diagnosis. And having that long curve—that's amazing and super exciting. But also being able to see patients in clinic and have it be a good visit, a visit that's about kind of the successes that have happened, and less about the toxicity. I think that's a really impactful opportunity with something that has not those cytotoxic side effects, as you mentioned.

Garo Armen30:14

Now what about the prospects of having patients be treated with botbal, for example, for a reasonably short period of time, and having results without necessarily the need for chronic, continuous treatment? Because as we know, with traditional cytotoxics, if you stop treatment, often the disease comes back very quickly. So you have to continue on treatment, and of course there's the cumulative toxicity of that treatment.

Jonathan Laurie31:00

Yeah, that's what really excites me in clinic—to have that as a possibility for the patient sitting in front of me, and it excites them as well. And that time off therapy is a really important metric, because that's time that people can travel, they're not tied to coming in to see me continuously. It lets them prioritize the things that they want to do. So I think you highlighted a really impactful benefit of something that, if patients have a durable response, they can enjoy those other aspects of their life and not be tied to the chemo center. I love those appointments when somebody comes back and tells me about the trip that they just had, and this amazing thing that they did, and the grandchild that they got to hold, because they were able to travel to someone because they didn't have to be here for everything continuously.

Another thing that my patients tell me that they want is they want quality of life. And many of our surgeries and our treatments lead to impaired quality of life—for bowel function, sexual function, overall health. Thinking about the surgeries that are required, sometimes requiring a lifelong stoma. And so the opportunity for organ preservation and for cancers to either disappear to a point where it's a different surgery that might provide a better quality of life, or maybe non-operative management is a possibility. And I think as people gain experience and understand kind of the effect of something that works on a typically cold tumor, they're going to be really excited about that—both patients and providers.

Garo Armen32:34

And are you seeing early signs of this amongst the exploration of your expansion to, beyond your center, in Canada, France, Australia, New Zealand?

Jonathan Laurie32:49

Yeah, I hear from investigators all over the world, you know, where are things at? We're excited about this. Can we be part of this? And so I think the momentum is incredible, and that's quite an exciting thing to be a part of, and I'm very grateful also of all the things that have helped make that momentum possible. There's great collaboration both with the clinical development team at Agenus, but with our clinical colleagues across these cooperative groups. We have this shared history that's really rich over the past 20, 30 years where we've done lots of trials together.

Garo Armen33:24

That's wonderful to hear, actually. So when we started the trial efforts, John, we said, well, how quickly can we gear up to get this thing started? And if you can give us a sense of what has really driven the speed with which we have arrived to where we are, and the level of excitement that has driven the speed, and how quickly your organization has geared up to put all the elements in so that the first patient in can be accomplished as quickly as possible.

Jonathan Laurie34:04

You highlighted a really key word, and that's enthusiasm. I think there's a lot of enthusiasm amongst sites and the central offices and our patients, because of the data that they've seen to date, and because this is a group that really needs something new. We see so many patients who are still well and they've run out of treatment options and they need more things in our toolbox and they need different things. We've talked a little bit about potential side effects that can happen from chemotherapy. This is a different drug that affects patients differently. It's durable. That's really exciting to providers. They've seen how good immunotherapy works in microsatellite instability-high colorectal cancer, and the opportunity for that in the 95% of patients that don't have microsatellite instability-high—that's huge. That gets people really excited.

And when you combine that with the Canadian Cancer Trials Group's experience running large trials, working together with our collaborators at the Australasian Gastrointestinal Trials Group, AGITG, and Unicancer in France, there's this shared history where we work together. We know each other's policies. We know the things that are important for each site. We know the protocol, kind of the key important pieces that need to happen to put a trial together that's successful. And we know each other. And those relationships are really important. It's not just receiving an email from someone that you don't know. It's someone that you've known for years, you've worked together, you have a shared history. And that's really important.

So you say, I've got this really exciting opportunity for us, and people get excited about it. And it's really infectious, and that's been exciting. We've done a lot of groundwork, and so that groundwork has been important for getting our sites excited. You know, there's one thing of all the operationalization that happens at a central office and between institutions in different countries, but getting sites excited about this and telling them we've got a trial, it's going to be for your patients, these are the compounds, this is the exciting part—that's really important for kind of getting the system ready and priming the pump, so that way things are ready to go. And when you combine all that together—the groundwork, the excitement, that shared history—it's really led to something remarkable as far as how fast things have gone. You know, we've gone over a period of about four months from contract signing to protocol development, regulatory approvals in multiple regions, to now us having sites asking, let's go, we're ready to activate—and that's really exciting. So we are moving very quickly.

Garo Armen36:33

That's powerful. That's very powerful. Thank you very much for that. And all of this obviously catalyzes a process by which we can achieve enrollment quickly and collect the data on the important endpoints. And we appreciate your being a major driver of the BATMAN trial, and we are very excited about working side by side with you to make sure that we complete enrollment quickly and that we also get the readout from the trial as quickly as possible for the benefit of our patients. Thank you.

Jonathan Laurie37:20

Thank you.

Garo Armen37:25

So we thank Dr. Laurie. His remarks highlight a critical reality, and as he said and others have said, patients around the world are looking for treatments that extend life, but also importantly allow them to live without the burden of traditional treatments like chemotherapy, which could have lifelong impact on the quality of life. The momentum behind the phase three program reflects the need and the possibility of investigators around the world, and their belief in such an outcome, and that is now within reach.

Garo Armen38:08

It's important to remember why we do all this work. Every data point represents a person, a family whose life is shaped by the options available to them. What stands out most in our work with CCTG and our global partners is the level of enthusiasm that is building — the kind that accelerates timelines, removes barriers, and aligns teams across many continents behind a shared purpose: improving the lives of patients with colorectal cancer and many other types of cancers, which were the subject of our ESMO presentation in Berlin about a month ago. This brings us to our next segment. Our next session is with Benny Johnson. Benny joined us a little over two years ago from one of the world's most renowned cancer centers, MD Anderson Cancer Center in Houston, Texas. Shortly after he joined the company, his wife was diagnosed with stage three colorectal cancer. Here is Benny to tell us about his experience joining Agenus as well as going through that process with his wife. It's been a delight to have you at Agenus as a colleague. Before Agenus, if you could give us a synopsis of what you did — more importantly, how did your daily life look taking care of patients?

Benny Johnson40:05

Before joining Agenus, Garo, I was an assistant professor in GI medical oncology at MD Anderson Cancer Center in Houston. My focus was primarily colorectal cancer patients and anal cancer patients. As my career evolved at MD Anderson, I took on a particular interest in young onset patients and worked towards developing that program. So my clinic really became a clinic full of peers, if you will — about two days of clinic, two or three days with research, trying to work towards clinical trial design and investigator-initiated studies.

Garo Armen40:43

Your decision to join Agenus — and how did your knowledge of botbal materialize even before you joined Agenus, and what was the critical driver for you?

Benny Johnson40:56

A good amount of my time was spent on investigator-initiated studies and finding the right collaborators and sponsors, because when you see exciting data, you want to partner with those companies early to help run meaningful trials and move the needle forward for metastatic colorectal cancer. The way Agenus came to me was interesting. One of my mentors, Dr. Michael Overman, sent me an email saying there was a Phase 2 trial being proposed in colorectal cancer and he wanted me to lead it and increase our interaction with this company. The excitement was around the Phase 1 data showing, in refractory MSS colorectal cancer patients — which is 95% of our patients — response rates with the botbal immunotherapy combination that we had never seen before in MSS colon, never over 20%, with durable responses and a percentage of patients potentially even being cured. I had the opportunity to be the Phase 2 PI, and through interactions with the clinical development team, there was an opportunity at Agenus that felt like continuing the same mission — moving the needle for the majority of metastatic colorectal cancer patients. I jumped on it. It was an amazing opportunity to be part of this team.

Garo Armen42:39

So it wasn't just a job at another company — there was a greater purpose in all of this?

Benny Johnson42:48

100%. We all want to find meaning in what we do, and the experiences I had at MD Anderson were really formative for me. Having the opportunity to take a really powerful combination and think critically, working with a talented team here at Agenus to push the boundaries and bring it to more patients sooner — that was an opportunity I wanted to dive into, to help many patients with colon cancer, not just the few I see in my clinic, but a global need, and being a part of that.

Garo Armen43:27

So you join Agenus and then you get hit with a personal challenge. And of course you come from a medically sophisticated family including your wife. How does that factor into your decision-making to deal with that challenge?

Benny Johnson43:46

About four months after joining the company, we found out that my wife was diagnosed with a sigmoid colon cancer. Leading up to that point, when we actually received the diagnosis, we both knew something wasn't right. She had new GI symptoms, change in bowel habits, periodic bleeding. And we both knew, without saying it to each other, there was urgency in getting to the bottom of this. For many weeks, the two of us never said what we were thinking aloud to each other. I think that's because, as you mentioned, having my background, but even my wife who has a tremendous amount of background in primary care — she understands these red flag symptoms. And one of the things about young onset colon cancer is that primary care physicians are still learning that a young patient, less than 50 years old — a 30-year-old, 40-year-old — can actually have colon cancer. That's really not on the top of their mind or their differential. We saw that even as two healthcare providers — this delay in diagnosis. When she was found to have anemia, we were told to just take iron pills for a couple of months and come back. When we told an OB/GYN she was having unusual pelvic discomfort, she was told, 'Well, now you're over 40, you just have different symptoms now.' It was really sad and surprising to me that that still happens. We advocated for ourselves because we understand something's not right. But for the lay person, I think they would just believe their doctor and say, 'Okay, I'll do what you say and come back six months from now.' And unfortunately, for some patients that may result in advanced disease. So we were able to move forward, and she was diagnosed with sigmoid colon cancer, and our lives changed immediately.

Garo Armen45:57

And you have children of course, and that makes it challenging. So what factored into your decision for your wife to be treated with botbal?

Benny Johnson46:10

I knew what was on the table for a patient with clinical stage three disease. Standard of care is upfront resection followed by three to six months of adjuvant FOLFOX or CAPOX — two chemotherapies with side effects. But in the back of my mind, I've treated many patients like that, and unfortunately even with our best treatments, 22 to 30% of patients will still recur within two to three years. That statistic was in the back of my mind, and I wanted something more. The timing was remarkable — having experience with botbal as a Phase 2 PI in the CRC program for advanced disease, seeing those responses, and then joining the company to see early published data from the NEST clinical trial, a neoadjuvant trial of botbal for patients with resectable colon cancer. So how do you take that mindset — 'Hey, there's this trial that's an option for you' — and also know the standard of care, and then present it to my wife? My wife comes from a very educated family. I had to convince them too, explain the novelty. The fact that we have one chance to do our very best — at that moment, we felt it was the right decision. Ultimately, she decided she was willing to do whatever it takes.

Garo Armen47:56

What happened? She gets treated. How many treatments did she have?

Benny Johnson48:02

She received one dose of botbal, two doses of botbal peroperatively, and then went for endoscopic evaluation. Within seven weeks, we saw that a very large sigmoid tumor had complete resolution endoscopically — what we call a clinical complete response. Her surgeon, and we, still decided as part of the protocol and standard of care to move on with surgery, where we confirmed a complete 100% pathologic response. This was amazing news for us. She often says I really wasn't breathing when she started the clinical trial, and up until that endoscopy was when I was able to exhale — I was holding my breath for months. That was a really powerful moment for her and for me. Most patients would go on to get three to six months of adjuvant chemotherapy, and for young patients there's this idea we need to give them everything. So she may have received six months, at the very least three months, and it would have been two drugs. But because she had this amazing 100% pathologic response, we were able to deescalate her adjuvant chemotherapy to a single agent. We look at it as an unbelievable win for our family — she was part of a really novel immunotherapy combination that I think will eventually change the entire landscape for localized colon and rectal cancers. And to deescalate her adjuvant chemotherapy is huge. These treatments come with long-term side effects, and for someone like her — a runner with an eight-year-old and a three-year-old at home — peripheral neuropathy would have been crippling.

Garo Armen50:02

Here you are, a colorectal cancer specialist. You join a company with a remarkable treatment. Your wife comes down with cancer shortly thereafter, gets treated, and you witness the outcome firsthand. How does all of this factor into your thoughts as a professional as you're building a career?

Benny Johnson50:32

The lesson here is this is not just an old person's disease. Colorectal cancer can impact any of us, and the rising incidence in young people brings it to the forefront — seeing how close to home it hit. It really was one of the most challenging times of our lives. Even though I was taking care of these patients and had this huge admiration for what patients and families, especially young patients, were going through — now I had a front row seat. And I got to admit, I didn't really want that viewpoint, but I did. God decided for us to have it. Where it leaves me now is I'm just so thankful. I've been able to see botbal on all sides of development — as an investigator, and now here at the company developing it further. But her story is one of many other stories. As we see the mature NEST data that will be published soon, this is a powerful regimen impacting many other patients with very similar results. It drives me to move it forward as an available therapy for all of our patients, to change where localized colon cancer is going. Currently we're still using the same therapies we've been using for over 20 years, and I think it's time to move that needle. Having this front row seat has provided a real passion to do whatever it takes to innovate therapies for our patients. If you have stage three disease and you're doing everything at the best centers with the best oncologists and surgeons, and we're still seeing a 22 to 30% recurrence rate — it's just not enough, because that percentage impacts one family.

Garo Armen52:48

So as you said, it's not just one patient. It's now scores of patients that have experienced remarkable responses. If you were to explain to a patient, knowing what you've gone through, this optionality — how would you paraphrase the advantages of having botbal?

Benny Johnson53:13

Say we want to do everything we can to train your immune system to fight your cancer. And if we have drugs now that are able to do that, that is the change. It's not just a matter of giving therapies early. There's data now showing that if you give standard chemotherapies like FOLFOX or CAPOX before surgery, the response rates are still very low — it's not what we're seeing when you give novel immunotherapies like botbal before surgery. It's a significant difference. It's about giving patients their best shot and using their immune system to their advantage to fight the cancer in a way that results in lasting change and cure.

Garo Armen53:59

If your wife looks back at her experience, how does she tell her own story in terms of her own experience versus what she would have expected when she was first diagnosed?

Benny Johnson54:15

Looking at it now — an abbreviated course of therapy, having her surgery, and then being able to deescalate chemotherapy to a single agent drug for about three months — the benefits have been so impactful for her. She's not having to deal with chronic chemotherapy toxicities or the risk of developing peripheral neuropathy from oxaliplatin, because she was able to avoid the drug altogether. That's been huge. She's kind of back to what she was doing before — looking for a new job, getting back to running, being fully available at the kids' school, and taking care of both of our children. Being able to avoid some of these therapies played a role in that for sure. She's very thankful. Last year was a year where we just needed to survive. This year has been one where we're unpacking it. One of the things she said is, 'I'm just so thankful that I was able to receive this therapy and now be done with therapy a lot sooner on the back end.' She has no long-term side effect profile, which is really unique, and something we were so happy for her to have that opportunity.

Garo Armen55:47

Based on your experience as an important member of our clinical team — we've treated over 1,200 patients across nine different types of cancers, in the last-line setting as well as in the earlier stage like your wife's case, and it's a chemo-free option. Young patients want something more innovative, and luckily for your wife that innovation was available in time. What are the chances of all of this happening? You joining the company, four months later your wife comes down with it, and by then we have data that convinced not just you and your wife but your family to participate in this trial. Beautiful outcome.

Benny Johnson56:31

We are doing tremendous work with amazing investigators all across the globe. The excitement from oncologists here in the United States and globally speaks to the data, the novelty, and the potential to really transform solid tumor cancers. It's a miracle. I think about the fact that I'm here — it's not a coincidence — and I get to be part of this wild ride, working with an amazing team that is focused and dedicated, even though we're a small team. Each of us has these stories and has the patient or family member in the back of their mind who's been impacted, and we realize the current standard of care is just not enough. Agenus has this amazing pipeline, this amazing drug in botbal that we will bring to the finish line — that's our goal. Patients benefit, and that's why we're here. I'm truly excited to be part of the team.

Garo Armen58:10

Thank you very much for that, Benny. We're delighted to see your wife had such a phenomenal outcome. Benny's with us today along with members of our technical, medical, and commercial team to field questions. We appreciate your transparency, Benny, and sharing such a deeply personal journey with us. Your family's experience reminds us of the urgency, as you stated, of patient access to a treatment option like botbal. Taken together, today's discussion reaffirms the importance of our mission: number one, patients need better options; two, the path forward is becoming increasingly clear. With that, we'll turn to your questions and continue the conversation with our leadership team. Stephanie, take it away.

Stephanie59:17

Great. Thank you so much, Garo. Welcome to our Chief Medical Officer, Dr. Steven Oday, Chief Development Officer Dr. Richard Goldberg, and welcoming back Dr. Benny Johnson. We also have other team members based on the questions we were receiving — Dr. Dan Chan, our VP of Research, and I believe our Chief Commercial Officer Robin Taylor is joining back through travel. Thank you all for joining us. I'm going to jump right in because of time. We had some questions submitted from our October call that we didn't get to, and I'll give these to Dan. Some are related to our partnership and collaboration with Noetic, which we announced a couple of months ago. Is there anything that has come out of that, or can you share the status of the work being done with Noetic and their AI platform?

Dan Chan1:00:24

Yes, thank you, Stephanie. This is Dan Chan, Head of Research at Agenus. Our collaboration with Noetic is focused on identifying biomarkers that can predict response to botbal. While these studies are still ongoing, I'm very excited by the early results — we're starting to distinguish at the molecular level responders from non-responders. As this data matures, it will empower us to select patients most likely to benefit from botbal. We expect to share these findings with the broader scientific community as the data matures — stay tuned, we're hoping to share as early as next year.

Stephanie1:01:05

Great, thank you Dan. While you're on the line, there was another question I think would be appropriate for you. Is there any plan to look at other specific biomarkers? Particularly, there was a question about c-MET inhibitors or potentially EGFR. Can you comment on any specific biomarkers or work related to that?

Dan Chan1:01:28

Great question. We're definitely exploring a range of biomarkers to identify patients most likely to benefit from botbal. What's been really interesting is that we're seeing clinical activity independent of traditional biomarkers, which fits botbal's unique mechanism of action. Regarding c-MET and EGFR specifically — these are well-established biomarkers in lung cancer, but less well known for their role in immunotherapy response in colorectal cancer. While our focus right now is on colorectal cancer and prioritizing biomarkers for that population, we'll absolutely continue to explore other biomarkers as our development of botbal and other indications mature.

Stephanie1:02:14

Great, thank you Dan. Let's switch gears. There was a question submitted related to the Priority Voucher Program, and Dr. Goldberg, perhaps you could answer. We can't comment on where colorectal cancer sits in the priority list for the FDA — we don't have those specific insights. We know colorectal cancer has been top of mind in communications from the administration and FDA, but can you share what our plans are for submitting a voucher, the status, and whether we've tried to take part in that program?

Richard Goldberg1:02:59

Sure. When we heard about the Director's Voucher Program, we were very excited. The director came out with statements that he hoped to shorten the time to getting drugs that satisfy unmet need into the hands of oncologists and patients as quickly as possible. We immediately submitted an application for botbal. Unfortunately, we weren't one of the ten drugs chosen. But we were heartened when an announcement came for a second group of drugs and applications to be examined, so we immediately submitted again. The voucher process is actually a very brief two-page application. I also sent an email to Dr. Marty Makary, the FDA director, adding a few details about what we've been explaining today. We haven't heard back — I don't think anyone has heard back about the second tier of applications — but we're waiting with bated breath.

Stephanie1:04:33

Great, thank you Richard. I have a question here that's just been submitted for Garo. Let's see if we can get Garo back on camera. The question is related to Zidus and CFIUS review — could you comment on how operationally the ownership transition of the manufacturing facility is progressing? And there's also a question about the botbal supply and whether we have that secured for the Phase 3 trial.

Garo Armen1:05:07

Sure. With regard to CFIUS and the Zidus transaction, as you know we had some unforeseen events, including the government shutdown that put key workers in hibernation. But we've come out of that, and we're hopeful a CFIUS decision will be made very soon. With regard to the Zidus team, we've been working very collaboratively all along. They extended a $10 million loan to us to make their commitment clear, and it continues. We will continue working collaboratively post-closure. Once CFIUS clears, we expect to close the transaction within a week. We had a meeting with the team yesterday to make sure everything is lined up for an expeditious closure. After the transaction, we'll benefit from the collective resources of both the Agenus team and the Zidus team coming into place. With regard to supply, we have a substantial amount of botbal drug substance that could be converted to drug product very quickly — enough to treat tens of thousands of patients, and you can extrapolate from that the potential revenue upon approval. Separate from that, we have ample supply to conduct the BATMAN trial in the form of drug product undergoing labeling and packaging. That portion is secure. We've shipped the first batch of product to Canadian pharmacies, where we expect the first enrollment to take place prior to France, Australia, and New Zealand.

Stephanie1:08:10

Great, thank you for that thorough answer, Garo. There's actually been a lot of questions coming in, so thank you all — please continue to send them to [email protected]. If we don't get to them today, we'll address them at future webcasts. The next question I'll share with Dr. Oday. We have a number of important investigator-sponsored trials running. Which ones should we be watching most closely in terms of new incremental data — those with high unmet need, particularly beyond colorectal cancer? We have neoadjuvant studies as well as other data from our Phase 1b study. Can you share your perspective on which ISTs we should watch closely? Stephen, I think you're still on mute perhaps — can you double check? [After confirmation.] We can hear you. Thank you so much.

Steven Oday1:09:32

Okay. So we have four major ISTs at major centers around the world: the NEST and the UNICORN ISTs that are colorectal-based, a pan-tumor IST with Dr. Myriam Chalabi at the Netherlands Cancer Institute, and a new rectal-dedicated IST at Memorial Sloan Kettering. These are compelling — maybe, Dr. Goldberg, you can continue on this.

Richard Goldberg1:10:08

Right, I can pick up where Steven left off. These four studies are looking at botbal in the neoadjuvant setting, similar to the setting Benny's wife received the drug for. What we're seeing in initial studies is broad activity across colon and rectal cancers, as well as other cancers where adjuvant and neoadjuvant treatment is commonly given. We're excited about data coming from the Netherlands in triple-negative breast cancer. As a consequence, we're putting together future Phase 3 indication-granting studies, particularly in colon cancer. We also had a meeting with the FDA in August for rectal cancer. The real power of these immune-activating agents is going to be in patients with lymph nodes intact, because the source of immune cells is the lymph nodes and lower tumor burden. We're really bullish on the potential to make a real difference, following the pathway Dr. Cercek blazed with her initial trial in MSI-high rectal cancers, where 100% of patients had complete responses. Of course, we're treating mostly MSS patients here, although some MSI-high patients have shown similar dramatic activity. Stay tuned — we're very hopeful this will change the paradigm in the management of colon cancer and potentially other cancers.

Stephanie1:12:23

Thank you so much for following up on that, Richard. It looks like we have Stephen back. There's a follow-up question: is there any indication of when we might anticipate having neoadjuvant or early-line data shared in publications or at upcoming congresses in 2026?

Richard Goldberg1:12:52

At this point that data is maturing. We did have an update last spring that is in the public domain. The trial at Sloan Kettering is accruing very quickly, but the data has to mature and patients have to complete treatment before we have more knowledge. The data at the Netherlands Cancer Institute is expanding as they accrue more patients across various indications. It probably will not be until ASCO next year that we would have an update on these data. So stay tuned.

Stephanie1:13:43

Great. We'll be sure to keep everybody posted when we have a better idea of those abstracts or data being available, either through manuscripts or congress presentations. Given the time, I want to be respectful of everybody's time. I'm going to turn it back over to Garo to close out the call. We do have submitted questions we didn't get to, but just like this time, we'll keep them and address them at our next webcast or earnings call. With that, I'm turning it back to Garo to close out our call, and thank you all for joining us today.

Garo Armen1:14:21

Thank you very much, Stephanie. I also want to especially thank our participating clinicians, our team, and all of you who have joined us today. What we've heard from Dr. Lou, Dr. Laurie, Dr. Johnson, and members of our team points to a profound shift underway in not just colorectal cancer but in all cold, warm, or hot cancers. The scientific insight that immunotherapy can work in those cancers has very important global implications for how we manage patients. We've discussed personal stories — patients who have experienced this, their family members — all reinforcing that patients urgently need better options and we are closer than ever to delivering them. Who would not want a chemotherapy-free, debilitating-treatment-free, mutilating-surgery-free option? This year we've seen encouraging signs across multiple fronts: consistent clinical activity across refractory and earlier-stage settings, our global Phase 3 trial launched with unprecedented collaboration with CCTG including principles like Dr. Laurie, and stories of real patients whose lives have been changed by access to this innovative therapy. These are not abstract accomplishments — they are reminders of what is at stake and what is possible. As we enter 2026, we're committed as a company to advancing the botbal program with the highest sense of urgency. Our highest priority is making sure every single patient who can benefit from botbal has the opportunity to be treated — through government-paid programs like the French ATU, self-pay, or private insurance. We will engage closely with regulators, with a near-term emphasis on ex-US regulators in pursuance of approval. To all of you — patients, clinicians, advocates, partners, and shareholders — we thank you. Your engagement strengthens our ability to succeed and to ensure patients and their families have access to less toxic, more effective treatments. We look forward to future sessions updating you on our progress in the months ahead. Thank you very much, and we wish you and your families a healthy, happy, and joyful holiday season.