The call in brief

In Q1 2025 Agenus centered its call on new, more mature Buckball (botensilimab + balstilimab) immuno-oncology data—AACR neoadjuvant pathological complete responses across multiple cancers and durable HCC disease control—and a renewed regulatory push, having requested a May 5 FDA Type B meeting on a dossier of >1,200 patients with two-year follow-up while touting more receptive FDA/HHS leadership. The company hired GI-oncology expert Dr. Richard Goldberg as Chief Development Officer and narrowed focus to colorectal cancer (refractory late-line and neoadjuvant) as its fastest approval path. Financially, cash fell to $18.5M from $40.4M at year-end, but operating burn improved (cash used in operations $25.6M vs $38.2M; net loss $26.4M vs $63.5M) with a target of sub-$50M annualized burn in H2 2025. To shore up the balance sheet, Agenus disclosed four formal proposals—an Emeryville facility monetization, a premium equity investment, and two Buckball licensing deals—expecting to announce at least one within days to weeks. Management also revealed productive prior EU CHMP interactions and intends to pursue a conditional approval pathway in parallel.

What went well
  • New, more mature Buckball (botensilimab + balstilimab) data at AACR 2025: Dr. Miriam Chalabi's NeoASIS neoadjuvant study showed pathological complete responses across multiple cancers, no dose-limiting toxicities, and all patients proceeded to surgery on schedule
  • Phase 1 HCC cohort data (Dr. Anthony El-Khouri) showed deep, durable disease control in patients heavily pre-treated with standard-of-care PD-L1 blockade plus Avastin
  • Strategic hire of Dr. Richard Goldberg, a renowned GI oncology expert, as Chief Development Officer to steer regulatory filings in metastatic CRC and other tumors
  • On track to cut annualized operational cash burn below $50M in H2 2025; Q1 cash used in operations fell to $25.6M from $38.2M a year earlier and net loss narrowed to $26.4M from $63.5M
  • Received four formal written transaction proposals (Emeryville facility monetization, equity investment at a premium, and two Buckball licensing deals) expected to materially strengthen the balance sheet, with at least one anticipated in coming days/weeks
  • Maturing dossier of >1,200 patients with two-year follow-up; phase 1 now 123 patients at 18-month median follow-up, phase 2 at >12-month median follow-up, some patients beyond 4 years with no progression
What went wrong
  • Consolidated cash fell to $18.5M from $40.4M at year-end 2024, underscoring a tight runway and reliance on near-term transactions to stay funded
  • Q1 revenue declined to $24.1M from $28M a year earlier (primarily non-cash royalty revenue)
  • FDA's July 2024 meeting delivered an unfavorable judgment, advising that the phase 2 study even with longer follow-up may not be adequate for approval, citing modest overall response rates
  • Company has had no interactions yet with the new FDA leadership; only requested the Type B meeting on May 5 and much of the prior oncology-division senior staff has departed
  • Management attributed the prior FDA stance to a New England Journal of Medicine article (Pazdur/Beaver) they view as flawed for excluding key cases and conflating IO-combination with IO-only data

Management Commentary

Zack Armen
Head of Investor Relations, Agenus

Thank you, Operator. Welcome to Agenus' First Quarter 2025 financial results and corporate update call. Earlier today, we issued a press release detailing our financial results and key corporate developments. A copy of the press release is available on our website at www.investors.agenusbio.com. Before we begin, I'd like to remind everyone that today's discussion will include forward-looking statements. These statements are subject to risks and uncertainties, which may cause actual results to differ materially from expectations. Please refer to our SEC filings for further detail. Joining me today are Garo Armen, PhD, Chairman and CEO; Dr. Steven O'Day, M.D., Chief Medical Officer; Robin Taylor, PhD, Chief Commercial Officer; Richard Goldberg, M.D., Chief Development Officer; and Christine Klaskin, V.P., Finance and Principal Financial and Accounting Officer. Now, I'll turn the call over to Dr. Garo Armen.

Garo Armen
CEO, Agenus

Thank you, everybody. Thank you for joining us today. Before we start on today's call, I will cover six priorities, or I should say we will collectively cover six priorities. First, we are going to present to you the newest Buckball data validating durable responses in historically untreatable cold tumors. I might stress that we're talking about new data and more mature data. We are going to talk about the strategic hire of Dr. Richard Goldberg and his mandate to steer our regulatory path. Next, we will talk about operational efficiencies that are on track to cut our operational cash burn to below $50 million annualized in the second half of this year.

Fourth, four formal near-term transaction proposals that we have received, including an Emeryville facility sale, a significant equity investment at a big premium, and two Buckball licensing deals, each individually or in combination, are designed to materially strengthen our balance sheet. Lastly, the changes in the new FDA policies that could favor rapid approval of transformative therapies and our recent request for a type B meeting, and we will provide you with some details as to the rationale of this. Before I get into the business update, I'd like to acknowledge a critical and growing public health crisis. This underpins everything we do at Agenus. Colorectal cancer is on the rise, particularly among younger people under the age of 50. Colorectal cancer incidences have doubled in the U.S. adults under 55 from 1995 to 2019, less than 25 years.

By 2030, colorectal cancer is projected to become the leading cause of cancer-related death in men under 50 in the United States. These younger patients especially need treatments other than chemotherapy, radiation, and life-altering surgeries, particularly in the young. This is important for the young and the old, but particularly in the young, these life-altering treatments can have a lasting, devastating effect. They deserve an alternative without life-changing side effects. That is what we think we offer to patients. These younger patients, the new leadership is particularly aware of this. The new leadership at HHS and the FDA recognize this grim reality of today's treatment. One of the president's first actions with Secretary Kennedy was to set up the Make America Healthy Again Commission, which is set to ensure and issue its report any day now. Secretary Kennedy has pledged to root out conflicts of interest.

FDA Commissioner Dr. Marty Makary has repeatedly stressed the need to accelerate approval of meaningful treatments. I underline meaningful treatments. This shift in regulatory environment is deeply encouraging to us and for the entire research community discovering and developing novel and effective therapies. It is an exciting time for us and some of our peers. We have new data, new leadership, new efficiencies, and a new environment at the FDA and the government. We will talk about these one by one. For botensilimab and balstilimab, which we call Buckball, as you know, we are generating consistent and compelling data across different lines of treatment, both in the neoadjuvant setting and in later line, and across multiple cold tumors that have historically defined standard immuno-oncology therapies. These include MSS colorectal cancer, a huge problem, certain breast cancers, sarcomas, hepatocellular carcinoma, and many more.

At AACR 2025, two weeks ago, there was a groundbreaking presentation by Dr. Miriam Chalabi of the Netherlands Cancer Institute. She presented results from the investigator-sponsored study of NeoASIS, 10 cancer studies. Remember, this is many different types of cancers in the neoadjuvant setting. If you remember, so far prior to this, we had generated data in the neoadjuvant setting of colon cancer. This takes that concept and broadens it to many other cancers. The study showed pathological complete responses across multiple cancers, no dose-limiting toxicities, and all patients proceeded to surgery unscheduled. Very important. As Dr. Chalabi stated, these findings substantiate the importance of this immunotherapy in early treatment settings, or I should say earlier treatment settings, because these patients are not really early cancer patients. They're stage three, and highlight the broad potential utility of this combination. She was speaking of Buckball. In liver cancer, Dr.

Anthony El-Khouri, Chief of Section of Developmental Therapeutics at the USC Norris Comprehensive Cancer Center, presented phase 1 data in HCC cohort data of Buckball in patients heavily pre-treated with available therapies, including PD-L1 blockade plus Avastin, which are the standard of care in last line, and still demonstrated deep and durable disease control. Very important for patients. Let me talk about our new leadership. Of course, we have fantastic leadership, but this is new leadership to be added on. To support this next phase of development, we welcome Dr. Richard Goldberg, a world-renowned GI oncology expert, as our Chief Development Officer. His leadership will be pivotal as we advance towards regulatory filings in metastatic CRC and other tumor types. Dr.

Goldberg recently authored a guest editorial in The Cancer Letter, arguing that IO approvals should be customized to spare patients unnecessary life-changing toxicities, the same theme that we talked about. Rather than speak on his behalf, I'd like to invite him to share his perspectives directly with us today. Dr. Goldberg.

Richard Goldberg
Chief Development Officer, Agenus

Thank you, Garo, for that kind introduction. Five years ago, I stepped away from formal leadership roles in academic oncology and from active clinical practice. That time has allowed me to support companies working on new treatments for GI cancer and to deepen my involvement in patient advocacy. Throughout that time, I keep hearing the same message from patients, from their families, and from colleagues. We need better treatments, especially for colorectal cancer. People want more time, better time, and ultimately, they want hope for a cure. This need is especially acute for patients with MSS colorectal cancer, where existing immunotherapies have offered little benefit. As an advisor, I've had the opportunity to evaluate many programs. What stood out about Agenus and what ultimately brought me back into a full-time leadership role was the potential for Buckball.

This combination represents one of the most promising advances I've seen in my career. It has the potential to shift outcomes, not just in colorectal cancer, but across a range of difficult-to-treat solid tumors, which represent the biggest challenges in achieving cancer cure. The opportunity to help move these agents forward, to gain FDA approval, and make them accessible to oncologists and patients across the world is what's compelled me to re-enter the field. I'm excited to be here, and I look forward to working with the exceptional team at Agenus to bring forward new hope and meaningful treatments for our patients. These patients especially need treatments other than chemotherapy and radiation and life-altering surgeries. They deserve an alternative without life-changing side effects. The new leadership at HHS and FDA recognize this. Thank you, Garo.

Garo Armen
CEO, Agenus

Thank you very much, Richard. It's a real privilege to have you on board, given your career and given the fact that you know this disease inside out, and you've been gracious enough to invest the time to really understand our data inside out. With that kind of endorsement, we're very grateful for your leadership in our next chapter. As we indicated in our March call, we are on track to cut our annualized operational cash burn below $50 million in the second half of 2025. This is going to free resources to unlock Buckball and its full potential, not just in colorectal cancer, but beyond. As we mentioned, Buckball is a very powerful IO agent that shows activity, and this is corroborated by some of the leading experts across different cancers that are familiar with IO.

Before we move on to the financial review by Christine, let me address capital strategy head-on. Over the past several weeks, Agenus has received four formal written proposals that would inject or should have the potential to inject substantial new capital. The proposals would allow us to monetize on our state-of-the-art Emeryville Biologics facility. Each of these proposals also has the potential to expand into broader strategic collaborations. A third proposal offers a significant equity investment at a meaningful premium to our current share price. A fourth contemplates a Buckball licensing agreement with upfront cash, milestones, and double-digit royalties. Our board and our advisors are evaluating these proposals with a high sense of urgency, I might add. We anticipate announcing at least one of these transactions in the coming days or maybe a few weeks.

Any of them would materially strengthen our balance sheet while preserving long-term upside for shareholders and, most importantly, accelerating our mission to bring lifesaving therapies to patients. With strong scientific momentum, we remain equally focused on operational discipline. With that, I will turn it over to Christine to briefly review the financials. Christine?

Christine Klaskin
VP of Finance and Principal Financial and Accounting Officer, Agenus

Thank you, Garo. We ended the first quarter 2025 with a consolidated cash balance of $18.5 million compared to $40.4 million at year-end 2024. Cash used in operations for the first quarter ended March 31, 2025, was $25.6 million, which is reduced from $38.2 million for the same period in 2024. For the first quarter ended March 31, 2025, we recognized revenue of $24.1 million and incurred a net loss of $26.4 million or $1.03 per share. For the first quarter of 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million or $3.04 per share. Our revenue primarily includes non-cash royalty revenue. I'll turn the call back now to Garo to close out the call.

Garo Armen
CEO, Agenus

Thank you very much, Christine. In closing, for all the reasons we've discussed today, which include new data, new leadership, new efficiencies, and a new regulatory environment, in addition to anticipated near-term corporate transactions, we believe Agenus offers a great deal for patients and all stakeholders. It is for these reasons that on May 5, Agenus formally requested a Type B meeting with the FDA for Buckball. Our dossier is built on rigorous data from more than 1,200 patients, and now that is with a two-year follow-up, showing deep and durable responses. These deep and durable responses, by the way, are the hallmarks of effective IO treatments, as our Chief Medical Officer has always said. We believe our dossier meets every statutory criterion for potential accelerated approval. We're hopeful that the agency will engage promptly and judge our submission on its merits.

Our conviction in Buckball's curative potential has never been stronger, and our team is absolutely resolved in delivering this breakthrough to patients who have waited far too long, far too long. Thank you very much for your continued support and attention. Operator, we are ready for questions now.

Analyst Q&A

Emily Bodnar — Analyst, HC Wainwright
Hi, good morning. Thanks for taking the question. I guess to start with your commentary about regulatory interactions, how much longer-term follow-up do you have from the phase two study, and have you hit on the overall survival endpoint yet? Assuming that you speak to them, if they come back and say that you still need the phase three study, can you comment on your ability to run a phase three study and what that might look like? Thank you.
Garo Armen — CEO, Agenus
Sure. I will ask Dr. Steven O'Day to comment on the longer-term efficacy data. Perhaps I can ask Dr. Buell, who has graced us with her presence today, in addition to her responsibilities at MiNK. As you know, she is the Chairman of the Executive Board of Agenus and overseeing all of our regulatory efforts on the phase two question. Dr. O'Day.
Steven O'Day — Chief Medical Officer, Agenus
Thank you, Emily. Last year, when we presented to the FDA our data set, both our phase one and our phase two was in July based on a March data cut. We will have approximately one more year of data both in our phase one and our phase two. The median follow-up for the phase one, which now includes 123 patients, is 18 months, a substantial increase in duration from last year. The phase two trial has approximately just over 12 months of median follow-up, also significantly more than it did last year. The combination of both our phase one and phase two data with the longer follow-up will obviously be a significant factor in the next review with the FDA.
Garo Armen — CEO, Agenus
Thank you, Steven. Also remember, what's remarkable about these three seemingly separate studies, that is, phase one, cohort one, phase one, cohort two, and phase two, is the consistency of data across the board, which obviously makes the results much more credible. In terms of our next steps, as you know, last year, when we had the meeting with the FDA, they made, in our opinion, an erroneous judgment based on a paper that was published, which excluded some critical references and some critical data. Of course, this is not their fault, because they have a lot on their plate, but this erroneous decision resulted in them telling us that perhaps this study, even with longer-term follow-up, may not be adequate for approval. What is very clear and strikingly clear to us is that the longer-term follow-up is very indicative of survival benefit.
I mean, these patients, you can follow up for two years, five years. At some point, you need to give in and say, "This is indicative of survival." This is what we're basically making a point of. Dr. Goldberg, of course, looked at all of this data and concurred with this conclusion. That is one of the reasons he is here. Otherwise, this very, very accomplished man would have been very difficult to bring in from his so-called retirement at a young age. I am going to pass it on to Dr. Buell now to make comments about phase three because, of course, we are making plans for phase three. The question becomes, what indication and what types of phase three trials we are pursuing. Dr. Buell.
Jennifer Buell — Chairman of Executive Council, Agenus
Thanks very much, Garo. I'm just going to reiterate a couple of points here. Emily, you're quite aware of the work that we've done, and I think it's an important time. We're grateful for the agency's partnership as we concluded our July meeting last year. As they've requested, we're coming back with additional data. Steven just mentioned, we have more than 40% additional patients, more patients on the phase one with very mature follow-up. Of course, an additional year of follow-up on the randomized phase two, which did include a standard of care arm. We expect to present data on these data sets at a major upcoming conference that will be near term. You will have a sense of the depth and durability of the responses.
As Garo mentioned previously, the FDA had mentioned to us, again, this was a year ago, that they advised submission of the results, and this is specifically an outcome of the meeting, due to the modest overall response rates and the fact of the ability of the response rates to reasonably predict a meaningful benefit for patients. The reason that this response was really quite surprising to us was that given the clinical outcomes that we submitted at the time, we demonstrated more than fourfold, four to fivefold improvement in tumor shrinkage or response rates and a more than doubling of overall survival in this very hard-to-treat cancer. Since then, now nearly a year later, our data have further matured, reinforcing and extending the clinical impact in which, in fact, we've got some patients out beyond four years with no progression.
We are really quite excited to bring the data back to the agency. I think with this new evolving administration, we share the urgency to bring new medicines to patients, particularly in this growing prevalent disease right now that is impacting the young as well. As far as next steps, we will also talk with the agency about our randomized design. We are presenting two different approaches to the agency because we have, quite frankly, as Garo mentioned, parties who are really interested in helping us accelerate the development of these for patients with the highest unmet need for which there are currently no available therapies and for patients building on what you observed from the ASCO GI data and Miriam Chalabi's data in patients in the earliest disease, neoadjuvant disease.
Garo Armen — CEO, Agenus
Thank you, Jen. As we all know, besides the important box-checking regulations, rules, and regulations, drugs have to be demonstrated to be efficacious. In other words, they're active and they're safe. I mean, safety is, of course, relative to the patient population that we're going after. One of the most striking features of Buckball is that in the neoadjuvant setting, the efficacy is black and white because we're not aware of very many agents out there, let alone IO agents, that within a span of four to eight weeks result in complete resolution of the tumor. This is what we've seen visually and in terms of pathologic complete responses in the neoadjuvant setting. As to, as Jen talked about, in the late-line setting, I think she was being modest by calling the response rate modest.
Of course, she also mentioned that it is three, four times better than anything out there because, as you know, in late-line setting, response rates of approved products out there range from 1% to a maximum of 7%. Depending on the patient population, we're at least twice that, in most cases, three times that, with a longevity of the durable responses, which should translate to survival benefit. That is the specific nuance here. Thank you.
Emily Bodnar — Analyst, HC Wainwright
Thank you.
Mayank Mamtani — Senior Managing Director and Group Head of Healthcare, B Riley Securities
Yes, good morning, team. Thanks for taking our questions. Pleased to see Dr. Goldberg join the team here. Are you able to discuss any development plan changes or update in light of the recent AACR update? Thinking your NeoASIS trial did have some non-CRC patients like TNBC, and also, obviously, you had the late-line SCC cohort update. We are just curious how, as you go into a type B meeting, some of these non-CRC chemotypes kind of play a role in your longer-term development strategy, or are you just very focused on CRC to get this meeting very focused on CRC? If you could clarify that. I have a follow-up.
Garo Armen — CEO, Agenus
We believe that the shortest distance between presentation and approval is in the colorectal cancer setting. There are two settings where we believe that this is important. One is in refractory disease, either third or fourth-line therapy. One of the interesting observations from the emerging data is that the response rate looks the same in third line and in fourth line. That, I think, makes it clear that the mechanism of action of these drugs is divergent from the other drugs that patients have been exposed to. The other area that we're excited about is in the neoadjuvant setting. As you may be aware, there was a recent presentation from the team at Memorial Sloan Kettering on their MSI-high patients showing activity in both MSI-high colon cancer and MSI-high non-colorectal cancers.
We believe that our approach is going to expand that indication to the much larger subset of patients who are microsatellite stable, who are not MSI high. The path that they have blazed in the MSI high group is a path that we hope to follow in the neoadjuvant setting, both in rectal cancer and potentially in colon cancer, where the potential to avoid all of the toxicities of surgery, radiation, and chemotherapy would be welcomed by patients.
Does that address your question, Mayank?
Mayank Mamtani — Senior Managing Director and Group Head of Healthcare, B Riley Securities
Yes, I guess the type B meeting focus, I heard that it's going to be primarily CRC focused. Is that fair? Having those two indications, late-line and neoadjuvant. Yeah, that's clear. I guess, are you able to comment on when do you expect the type B meeting to occur? Garo, the strategic discussions that you alluded to, I believe, would need to have those minutes in hand before you're able to move forward in a meaningful way. Is that fair?
Garo Armen — CEO, Agenus
Okay, I'll let Jen answer this very important question.
Jennifer Buell — Chairman of Executive Council, Agenus
Hi, Mayank. We actually have quite a bit of data and information from the FDA, which has satisfied the discussions that you're referring to, the strategic discussion. The path forward from our perspective is really quite clear. The opportunity is what we want to speak with the agency, which is the fastest path to get these products available to patients. That's independent of the strategic discussions.
Garo Armen — CEO, Agenus
Yeah, I think that's a very important consideration. Yeah.
Mayank Mamtani — Senior Managing Director and Group Head of Healthcare, B Riley Securities
Lastly, if you're able to comment on the European counterparts also, as that obviously has been a separate engagement. Any update there?
Garo Armen — CEO, Agenus
Sure. Jen will tell you what our history has been with Europe because right after the unsatisfactory meeting with the FDA last June, we engaged with CHMP and the European authorities. The outcome of those meetings, I'll let Jen comment on.
Jennifer Buell — Chairman of Executive Council, Agenus
Thanks, Garo. Mayank, we have not previously disclosed this. This is really the first that we're disclosing. The interactions with CHMP and the scientific advisory group last year was incredibly productive. The team was very prepared, impressively so. They agreed with us on our selected dose. They agreed that we had achieved contribution of components, and they agreed with a two-arm randomized trial for registration. Now, the conditional approval pathway is a possibility for us that we're going to go ahead and pursue. We're talking with the U.S. FDA, and we plan to talk with the EMA. Essentially, in parallel, the initial interactions with the FDA will occur first, though.
Mayank Mamtani — Analyst, B Riley Securities
Thank you. Understood. Thank you for taking our questions.
Matthew Phipps — Group Head of Biotechnology Equity Research, William Blair
Good morning. Thanks for all the detail here on the updates. Garo, I think before you've provided some valuation framework for the Emeryville facility, and I'm wondering if that value has increased given the focus on kind of onshoring pharmaceutical manufacturing over the past few months.
Garo Armen — CEO, Agenus
I think this is a very, very good question. When I say good, I'm not dodging the question, Matt. I believe that the totality of the value we will derive out of the Emeryville facility will reflect that premium. Of course, if we had the luxury to wait another 6-12 months, I think that we could get a lot more for it. Right now, it is a relatively inexpensive access to capital. Hence, we are pursuing that route, even though we believe the value will continue to go up.
Matthew Phipps — Group Head of Biotechnology Equity Research, William Blair
Yeah, that's fair. I'm sure you can't give us too much more details on some of the agreements beyond what you already gave. The licensing agreement, can you just say if that is geography-specific or if it is broader worldwide?
Garo Armen — CEO, Agenus
The two agreements which have been submitted to us in writing, proposals, are global. Two additional agreements that we are potentially looking at as an important option for us are geography-specific. Depending on our cost of capital considerations and immediate needs, of course, the global licensing agreements would contemplate third parties underwriting the entire cost of additional trials and registration for Buckball. It has that appeal because it will further drive our operating burn rate down. Let us sort through these because the sequence with which we consummate some of these agreements and bring in cash and create value will be critical in determining our next steps.
Matthew Phipps — Group Head of Biotechnology Equity Research, William Blair
Okay. Great. Thanks. Thanks, Garo.
Colleen Kusy — Analyst, Baird
Great. Good morning. Thanks for taking our questions. Have you had any interactions yet with the new FDA at this point ahead of the Part B meeting? Can you provide a little more color on the publication that you mentioned that led the FDA to its conclusion last summer and why you think that might be a different situation this summer?
Garo Armen — CEO, Agenus
Okay. I will answer the second question first. The publication we're talking about, I believe, Dr. Buell, correct me if I'm wrong, was a New England Journal of Medicine article by doctors Richard Pazdur and Julia Beaver. This article made a point that IO, in combination with other agents, where the response rates are at a certain threshold, do not necessarily result in long-term survival. However, there's a big however. Number one, these protocols discussed by and large were not IO-only protocols. There was IO, mainly PD-1, plus something else. That does not really reflect the power of the lasting durable responses generated by CTLA-4 agents. This is a very important point. Very, very important point. Secondly, this article excluded a number of cases.
We can think about four or five cases where low response rates, and when I say low response rates, I'm talking about single digits. I'm talking about 15%-20% response rates, did indeed translate to longer-term survival. It was somewhat partial in depicting the facts. Of course, that's one issue. Now, the second question that you asked, have we engaged with the new FDA? The answer is no. We have not because the new FDA is comprised of leadership like Dr. Marty Makary and a lot of the senior people at the FDA. I'm not talking about the cancer division, but a lot of the senior people, even in the cancer division, a lot of the senior people have left. We're looking at our type B meeting as an opportunity to reengage the agency.
However, the first step for us is to present the totality of the data. When I talk about totality of the data, remember, Dr. Goldberg made the point that our sharpshooting strategy will be colorectal cancer. However, the totality of data comprising our trials across nine different cancers, and of those nine different cancers, about five of them, both in numbers and in terms of durability of responses, have matured to a point where we can proudly demonstrate the consistency of data from one cancer to another to another to another. That is what we will be presenting as well.
Colleen Kusy — Analyst, Baird
Great. That's helpful. Thank you. Dr. Goldberg, congrats on the new role. I wanted to ask, how much of your time do you anticipate being focused on metastatic CRC versus neoadjuvant CRC versus all the other tumor types that Buckball shared activity in?
Richard Goldberg — Chief Development Officer, Agenus
I think Buckball has demonstrated activity really in virtually every setting it's been tried in. The main reason to focus on colorectal cancer is that there's such a strong need expressed by patients and physicians to have an IO intervention that realizes some of the benefits that have been enjoyed by MSI-high patients in the much larger subset of colorectal cancer patients that are MSS. The data for activity of the pre-approved drugs in late-line metastatic colorectal cancer is quite modest. While the oncology community has embraced those drugs, the patient community is disappointed by what they bring and is looking for something better. We believe that the comparators in the setting of advanced disease, third and fourth-line disease, are favorable comparator arms to the activity that Agenus has observed in the early trials.
Now, from my perspective, the most potential is probably in the neoadjuvant setting. The groundbreaking study by Andrea Cercek and her colleagues at Sloan Kettering in MSI-high tumors, where patients avoided chemotherapy, radiation, and surgery, is really startling and benefits patients in ways that we couldn't have imagined even five years ago. We believe that that's translatable to rectal cancer patients with MSS tumors using this intervention and to colon cancer patients, tumors above the rectum, where potentially we could come up with a surgery-free world for managing stage III colon cancer.
Garo Armen — CEO, Agenus
Thank you, Richard.
Colleen Kusy — Analyst, Baird
That's great. Thank you. One last one, if I may. Could you talk about your strategy of sharing the phase II data with the street, whether that would be in conjunction with the FDA meeting or after?
Garo Armen — CEO, Agenus
Sure. I think that's doable. I just want to draw your attention to the neoadjuvant protocol that was presented at AACR, whereby Myriam Chalabi presented data on patients with a fantastically acceptable safety profile. In fact, there were no real showstoppers in the safety of the drug. Of course, this is in the earlier disease setting with lower doses, 25 and 50. Nonetheless, there were no real safety signals of any sort, including colitis, to really worry about. We believe that depending on the disease setting, as Richard said, neoadjuvant offers the largest potential and earlier the better intervention philosophy, of course, particularly with immunotherapy. In that setting, we think we're going to be, based on all of the studies that have taken place, dealing with a safety profile that will be very, very acceptable to patients.
Colleen Kusy — Analyst, Baird
Great. Thanks for taking our questions.
Garo Armen — CEO, Agenus
Thank you very much, everyone. We are very grateful for your attention and for your persistence with what we're doing for the benefit of patients and elite stakeholders, as I mentioned. We are also very grateful to our expanded team. Dr. Richard Goldberg adds a deeper level of expertise in a disease that is the focus of our attention right now. This particular disease is becoming a major problem in the young and the kinds of morbidities generated by existing treatments, chemotherapy, radiation, and surgery could be eliminated, potentially eliminated. This is a very important issue because, as I said before, both with the young and the old, of course, these are important. With somebody having to live with these morbidities for the rest of their lives, we are getting patients as young as eight years old with metastatic colon cancer, which is something remarkable.
For a young person to live with these difficulties for the rest of their lives is a big issue. We are very grateful for all of your attention. We have been on a path to do what is in the best interest of these patients and, as I said, with our stakeholders. We very much appreciate your support. Thank you.
Source: AGENUS INC earnings call transcript (2025-05-12). Management commentary and analyst Q&A are reproduced as delivered; speaker roles as stated on the call.

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