Agenus Inc (AGEN) October 20, 2026 Conference Transcript

Fantastic. Okay, so we're going to deal with some shot clock issues here. That last session with Dr. Schlechter was supposed to be 25 minutes, 30 minutes. We cut that pretty short. But since Dr. Schlechter is very familiar with Bob Paul, we're going to have him on here with the team from Agenus, or Zach from Agenus, the team. So I'm delighted to have Zach Armin of Agenius with us, as I mentioned, Dr. Chuck has just walked us through the MSS colon cancer setting here. Agenius is one of the companies betting it can change that whole proposition of resistance to immunotherapy. It's been an eventful 2026, a strategic pivot into the neoadjuvant colon cancer setting up to 340 million financing that roughly double the stock in a single session and just last week the first marketing authorization anywhere about all um we have now 25 minutes or so so let's get right into it uh thanks for being here as well thank you and doctors like to chime in wherever you see fit absolutely um so you know picking up from that last session um in july you made a a decisive call stopped funding batman and late-line metastatic mss colon cancer and put the company behind robin and 850 million patient neoadjuvant phase three high-risk stage two and

three mss colon cancer uh why is the earlier setting the better bet scientifically regulatory and commercially and i know that was one of the points that you may want to address too so zach go ahead and then sure thank you thanks andreas and thank you dr shawker for for being here as well so we made the decision during the July financing sessions to move to the phase three Robin trial as our sole registration enabling trial focus as Dr. Flechter pointed out there is a significant need in the late-line minestatic center and the company continues to believe wholeheartedly in that and we've done we've pursued multiple regulatory pathways and other pre-marketing authorization pathways to ensure that patients have access to the drug. We have a compassionate access program where patients have access to the drug in 30-odd different countries. We have our program in France, which is through the AAC program, where the therapy is being reimbursed by the French government for patients in late-line refractory MSF colon, rectal cancer, sarcoma, and ovarian cancers. And as I just mentioned, we just got our first marketing authorization in our media for the advanced metastatic MSS colorectal cancer set. So we're doing everything we can from a patient access perspective to ensure that patients who want access to the therapy have ways that they can access it in multiple different countries. We did enroll over 1,000 patients now across the waiting line metastatic setting.

Dr. Schlechter and his team at Data Fargo were a big part of many of those trials. And so, you know, we have a plethora of data that supports the value proposition of this therapy across major length-line tumor settings, and we hope that that will become part of future-sponsored work.

It may become part of the way that oncologists decide to prescribe the drug, even if we don't have yet a label there. That's a completely separate commercial topic, which we'll get into. But as far as the company's focus and our strategic decisioning around moving to the Robin trial There were many factors. One, it was a bandwidth and resource consideration. It's really hard to go stand up a global face-through trial for any small and mid-sized companies. So the idea of doing two of them at the same time was, you know, concern around bandwidth and resources. And, of course, capital resources being something that are an important consideration in our industry and needing to focus those capital resources on the stage 2, 3 colon cancer setting was a decision that we came to. As Dr. Sleper pointed out very clearly and elegantly, this is the area where we can make the most profound impact on patients. When you talk about the ability to de-escalate the use of chemotherapy, in the case of rectal cancer, to de-escalate the use of radiation along with mutilating surgeries and preserving the organ, in the case of patients who have to receive an ostomy procedure, And then just the ability to drive higher event-free survival, these patients who have been treated with BOT-BAL in both nest and unicorn, those patients had a very short treatment course of BOT-BAL, and they all are remaining treatment free now for multiple years in the case of nest, and we plan to have updates in unicorn as well in the coming weeks and months. so that this is an exciting setting for us and for many oncologists around the world and we're really focusing all of our time and energy and getting the trial ready to be to begin at all.

Yeah maybe for Dr. Zuckerberg that question please.

Yeah I mean this is the challenge for the best of anything you will actually say again the capacity for factory disease setting but I think that it is a large population it is a population with need it's not that operating the idea that we can move on so yeah look you're talking about people in oscopy they get it says oh look there's a big thing in here they receive six minutes of therapy and then nearly half that is a room you can't ignore that response we don't know if that is what has that yeah the retell positive reduce

the recurrent activity so this short course of a therapy that has no delays

In term, you've been free survival in the second half of 29 and a final analysis in the second half of 30. What role does the 2027 path response in term play? Is it a potential accelerated approval readout or an internal go-no readout? Well, I won't comment on accelerated approval because that's been a subject of this company for a long time.

We've made it clear in many different instances that we believe the therapy should be made available to patrons in the United States immediately. So I won't go to any regulatory strategy beyond. When it comes to this trial, the timelines actually, I think, are very well designed to give the public investor out there a very clear understanding of where there are value inflection points along the pathway from today to a perpetual approval in this setting. We designed the financing to actually align very closely with those milestones. So the first you mentioned, Andre, is we expect to have first patient enrolled in Q1 of next year. We do believe that the study will enroll quite rapidly. There's a ton of enthusiasm among oncologists around the world, like they're being at the front of that line. And so if we see the enrollment that we expect, then the first catalyst that's related to the transaction is the 60th patient enrolled, which we anticipate to be a Q2 2027 event. That will trigger the first tranche of warrants that were part of the financing, which would generate 85 million of additional co-seeds if all warrants were exercised. The second major catalyst is the pathologic response rate in term readout that you mentioned. This is anticipated to occur in Q4 of next year, and that's on the first 100 patients treated in the study, 50 on the microbiome line, 50 on the control line, and that will simply be the pathologic response rate, which is 50% of greater tumor shrinkage, the percent of patients who had a PR, the percent of patients who had a major path response rate, is 90 to 99 percent tumor shrinkage and the percent of agents that have a pathological response rate. This is not a gating or go-no-go milestone related to the trial. It is not a primary endpoint. It is simply meant to deliver a read-through on a near-term endpoint for the company and for the market to see what that response rate data looks like. It's a confidence generator from the perspective of the investors and the financing that we they see that as a very strong correlation in terms of PCR to EFS hazard ratio. We actually showcased that in our webcast and in our latest corporate materials that we did a review of all of these prior neoadjuvant studies and saw that there is a very strong correlation between pathologically complete response rate and EFS hazard ratio. So it's simply meant to be something that's a catalyst for people to see how the trial is going.

And then ultimately, as you mentioned, the EFS endpoints are an interim read at 75% information fraction anticipated in the second half of 2029, and then a final read anticipated in the second half of 2023. Yeah, that's fantastic.

Yeah, that's hard. So it will be important to, you know, I said to anyone in this room, you have cancer right You could do a trial maybe now.

So I think that, um, the, the sales proposition and long-term survival data and agent T797 combination work at SITC in early November, plus NEST and Unicorn manuscripts in the second half. It's a great question for both. So maybe that's the second we can go to. What, what should investors take away from this flow?

I would say the data from NEST that is now published. If we have two, two trials.

So just to NEST, which typically 5% of those patients will have to occur. So among those 40, so those are 10 lives that would have liked because of a very short course of therapy that's administered through an IV and has a less than 5% chance of having any material adverse events. So from a patient perspective, we hope that this data generates confidence. And obviously from an oncologist's perspective, we believe that it will and we've seen that already. And as Unicorn, when Unicorn is updated, then we'll see whether that data is consistent and we feel strongly that it will be. The MSI higher DMMR is of course a setting where IA has proven to be beneficial. We will see the Neo-Acephalic full that the abstract came out of yesterday. And long story short, it was clear that there was a benefit as expected. But these were in highly advanced diseases where the tumor was protruding other parts of the biology and organs. So that seems to be an area where oncologists are looking for an optimal IA regimen to potentially benefit beyond what first gen does so i mean overall andres it's about this data continuing to support the rationale in the setting and continuing to generate a very strong risk benefit proposition which hopefully drives excitement and enrolling from the raw trial we just talked about i'm not actually sure enough data from so i think dmr i feel like is kind of

DMR is rare.

It's an important part of the whole story, it's not these current revenue drivers. And in the case of France, there's a willingness and a recognition from the regulatory agencies in that country that this therapy should be afforded to their patients and they should be reversible. That in our minds is a powerful message that we think investors should really pay attention to and acknowledge the fact that this therapy, while it's still experimental, has a strong degree of demand from patients across multiple different stage tumors and in multiple different jurisdictions around the world at the same time as far as we want to get everyone has at least a chance of knowing the information and being able to make informed the student about hopefully one day that's part of this group's job you guys for a great discussion here and following us right you know, it's an attitude.

Thank you.