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Fantastic. Okay, so we're going to be dealing 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. Shlechter is very familiar with Bob Hall, we're gonna have him on here with the team from Agenis, or Zach from Agenes, the team. So I'm delighted to have Zach Harmon of Agenus with us. As I mentioned, Dr. Slechter just walked us through the MSS colon cancer. setting here the genius is one of the companies betting it can change that you know whole proposition of you know resistance to immunotherapy it's been an eventful 2026 a strategic pivot into the new adjuvant colon cancer setting and up to 340 million financing that roughly doubled the stock in a single session and just last week the first marketing authorization anywhere without all um we have now around 25 minutes or so so let's get right into it uh thanks for being here as well thank you 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 decisive call stopped funding batman and late line metastatic mss colon cancer and put the company behind robin 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 andre so thank you dr for for being here as well um so we made the decision during the july financing discussions to move to the phase three robin trial as our sole registration and enabling trial focus. As Dr. Flechter pointed out, there is a significant need in the late-line anesthetic center. And the company continues to believe wholeheartedly in that need. And 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 to the drugs 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 MSS colon and rectal cancer, sarcoma, and ovarian cancers. And as Andreas just mentioned, we just got our first marketing authorization in Armenia for the advanced metastatic MSS colorectal cancer setting. 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 a over a thousand patients now across mid-line metastatic settings. Dr. Schweitzer and his team at Data Harbor 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 late-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 won't get into, but as far as the company's focus and our strategic decisioning around moving to the Robin trial in the United States, there were many factors. One, it was a bandwidth and resource consideration, it's really hard to go stand up a global phase three trial for any small and mid-sized outtake companies, so the idea of doing two 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 cold cancer setting was a decision that we came to. As Dr. Slutkin pointed out, you now, 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 deescalate the use of chemotherapy, in the case of rectal cancer, to de-escalation 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 were treated with BOT-VAL in both NAS and Unicorn, those patients had a very short treatment course of BOTVAL, and they all are remaining treated free now for multiple years in the case of MEST and we plan to have updates in the course as well in the coming weeks and months so 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 begin at all. Yeah maybe for Dr. Shocker so the question is earlier a better bet? Yeah I mean this is the challenge for the oncologist right like I have priorities. The best benefit you will ever see from bot is going to be in the neoadjuvant setting and I want to have it all. I want give it in the neoadjunct setting and the refractory disease setting. But I think that it is a large population. It is a population with need. It's not that operative because you don't have need. It's a population need. The idea that we can move away from chemotherapy that's at, you know, when you're nearly 50 years old would be nice. So I think that biologically the best place for a bot is in a lelagic setting, but it addresses only one of the very important needs. And maybe for both, and maybe Dr. Schillinger, you can start, but what about nest and unicorn gives you conviction that really, really was the right thing? Yeah, I mean, look, you're talking about people who have their diagnostic colonoscopy, they get the uh-oh, you have cancer conversation, They have a CAT scan that says, oh, look, there's a big thing in your abdomen. We can see it on the CAT scan. They received six weeks of therapy, and then nearly half of them had cancer. That is a remarkable response, and you can't ignore that response. We don't know if that means they're cured. Okay, that's an important caveat, and it takes a lot to convince oncologists that you cured people. We have very high standards for that work. But I would say that is really impressive data that we could have a major response, and it makes perfect biological sense. Perfectly said. Okay, let me ask you the opportunity question here. There are about 30,000 newly diagnosed U.S. patients a year. Could translate to roughly 7 billion in annual U. S. sales. What has to happen to get there? Yeah, the trial that we're about to embark on needs to read out positively. We have a strong degree of confidence that it will. And if it reads out positively, it means that we have reduced the recurrence rate by a significant margin. We have a hazard ratio of 0.65, so that would mean at least a 35% improvement in the recurrance rate. We believe we'll exceed that hazard ratio, but that adds up to the outcomes of the trial. We very likely will also see a considerable de-escalation of chemotherapy as part of the study's secondary exploratory points. and the maintenance of ctDNA negativity, which as Dr. Schlechter alluded to, is the best predictor we have of long-term survival and EFS outcomes that exist today. So if all of those things happen, we believe there's a very strong risk-benefit equation for any patient or oncologist to say, why would I not give this short course of immunotherapy that has no delays to surgery, that has less than 5% grade 3A, which are manageable will have it managed very strongly in the clinic. I still get to go and have the standard of care surgery and if I needed chemotherapy, but this IO regimen over a four to six week time course could cure me and avoid me having to deal with any more treatments for my cancer that no longer exists. Yeah, great. So think about the upcoming catalysts, quite a few. So walk us through the Robin timeline. First patient, Q127, interim pathologic response look into second half of 27. Interim event free survival in the second half of 29 and final analysis in the second half for 30. What role does the 2027 path response interim play? Is it a potential accelerated approval readout or an internal go no go? Well I won't comment on accelerated approval because that's been a subject of this past company for a long time. We've made it clear in many different instances that we believe that therapy should be made available to patients 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 potential approval in this setting. We designed the financing to actually align very closely with those last ones. 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, with Dr. Schlechter 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 transaction is the 60th patient enrolled which we anticipate to be a q2 2027 event that would trigger the first tranche of warrants that were part of the financing which would generate 85 million of additional proceeds if all warrants were exercised the second major catalyst is the pathologic response rate interpret that you mentioned this is anticipated to occur in q4 next year and that's on the first 100 patients treated in the study 50 on the bottom line 50 on the control arm and that will simply be the pathologic response rate which is 50 percent of the greater tumor shrinkage the percentage of patients who had a pr the percent of patients who had major path response rates which is 90 to 99 tumor shrinkages and the percent of patients that have a pathologic complete response rate this is not a gating or go no go milestone related to the trial it is it is not on primary endpoint it is simply meant to um to deliver a read-through on a near-term end point for the company and for the market to see what that what that response rate data looks like it's a confidence generator from the perspective of the investors and the financing that we did they see that as a very strong correlation in terms of pcr to efs hazard ratio and we actually showcased that in our webcast and our latest corporate materials that we did a review of all of these prior neoadjuvant uh studies and saw that there is a very strong correlation between pathological response rate and efs hazard ratio so it's simply meant to be something that's 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 in anticipated in the second half of 2029 and then a final read anticipated in the same amount of food maybe yeah that's fantastic um maybe you can just like you can comment on the importance of the interim 2027 yeah that is hard because it's not biologically important so it is it will be important to know that in multi-center studies that the path cr rate holds and if that i think will rapidly amplify interest in the study patients will know about I'm sure there will be an abstract in the presentation somewhere, and there'll probably be a paper on PASCR and some biological correlates. I hope so. That would be my advice. I'm going to be off. That would rapidly expand interest in enrollment. You know, one of the biggest barriers to enrollment in this study, and I hope that this timeline isn't too ambitious. I actually think it's going to be like a little slow start and then sort of like massively ramp up when the data comes out is that if I said to anyone in this room, you have cancer right now, you could do a trial, maybe it comes out later, or you could get it out right now. So I think that the sales proposition of this will be hard in the beginning, and if you can get a 40%, 50% pathocytology, I think this trial will just rapidly enroll once that first data comes up. that's my prediction of what would happen but patients wanted doctors wanted so i think um near return the three investigators sponsored posters at esmo madrid next week including neosis and dmmr neoadjuvant colon cancer then long-term survival data and agent t797 combination work at city in early november plus nest and uniform manuscripts in the second I would say the data from Nesta is now published, very compelling, you know, there's the link link nod nod that the group said the unicorns look pretty similar, if we have two publications with similar paths you already said that incredible, I think that's very, very, compelling. And that might be enough to generate massive early involvement in the trial. So two trials coming out with similar results, one in Italy, one on New York, that'd be great. Currently, MMRD, I mean, the regulation, M-R-D's already a subtle issue, there's something else you talked about. What else do we have? Long-term survival data and the Agent T-797 combination? Which is 797, that's right. Agent T. Oh, cool. Yeah, I don't know if that one's a very, very cool concept. I don't know if that's a very, very cool concept, but I don' know the data well enough. Yeah, so just to go back to the NEST and Unicorn data, I think I'll say it in lay terms, because that's how I think about this, I'm not a scientist or a doctor. In NEST, which we did publish the updated data with maturity out beyond two or three years, we have had no disease recurrences. typically patients who get standard of care surgery and chemo in this setting, around 25% of those patients will have recurred. So among those 40-odd patients between nest and unicorn, you have very likely 10 of those patient would have had a disease recurrence, and I believe it's typical that those are metastatic patients when they recur. So those are 10 lives that would have likely been negatively impacted that are not 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 won't. The MSI-higher DMMR is, of course, a setting where IDEM has proven to be beneficial. We will see the neoasthetic fold 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 auto-regimen to potentially benefit beyond what first-gen does. So, I mean, overall, Andres, it's about this data continuing to support the rationale of the setting and continuing to generate a very strong risk-benefit proposition, which hopefully drives excitement and enrollment in the raw trial. We've got about five minutes. We have one more technical question for you, and then we can talk about some more conversation and stuff, but we just talked about the more DNU adjuvant, where there's already a strong setting for PD-1 alone. Why is CTLA-4 combination at value there, and why should that be through the MSS? I'm not actually sure. If we think about where to focus our scientific and financial resources on our patients, if CTLA4 is needed with MMRD in the neologism setting. A few years ago, I would have said you absolutely need a CTLA 4. Now, I'm less certain, but there's enough data from Miriam Chalabi's niche that I think I think Neelajit and Ipiniva, which was a three-year, 100% disease-free survival, and a 90-something percent PASI-R, that there's a great data already, and I'm sure Pottenbaum would do just as well, maybe marginally better, but the numbers are so good that I'm not personally convinced that that's where resources need to be committed when there's other needs. But, so I think DMMR, I feel like, is kind of close to settled in the Neelijit setting. In the refractory setting, for those patients who don't respond, which is about a third, then there might be a place for the next generation of CTLA-4s or other approaches. That's personally where I would see an escape for DMMR. DMMR is rare. DMMR's really biologically important and interesting. It's not as important as NSS. Okay, fantastic. Zach, for you, so let's address the regulatory history directly. You alluded to that earlier. Today you have a marketing organization in Armenia and revenue from authorized access programs. How should U.S. investors weigh ex-U.S approvals and access revenue? It's an important part of the whole story. It's not the main driver of what we believe to be the outside value in our story, which we believe is going to be driven by the Robin trial and hopefully further sponsored work management setting where there is a game-changing opportunity with multiple environments, multiple billions of dollars worth of reference on the other side of that, these current paid access and compassionate programs will never get anywhere near that as far as a revenue driver, but they are important validators of a few things. Number one, there's a demand for this therapy today from patients, there is a willingness from oncologists to prescribe therapy to patients, and in the case of France, there was a willingness and a recognition from the marketing agencies or the regulatory agencies rather in that country that this therapy should be afforded to their patients and they should be impersonal that reminds the 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 late stage tumors and in multiple different jurisdictions around the world Okay, great. I think we've got two minutes here. Countdown starts. Back when you just started enrolling in April, when you pulled the program or the funding, how did investigators react? Does that affect any recruitment for Robby? going forward i mean i can speak for myself honestly we were pissed okay um you know it was like it was like an unexpected breakup with your high school girlfriend or boyfriend um it was very disappointing it's not that it's not understandable we can all deal with constraints but it was very disappointing because again people in the exam room who like who it's just gut-wrenching is refractory disease and so I understand that the drug is best suited in the neoadjuvant and I understand there are financial market forces just like I have to make decisions as the colon cancer and rectal cancer director for Dana-Farber about how we locate our resources for examiners and procedures things like that but it was pretty rough at the same time we all believe in immune therapy, who doesn't, right? So I don't think that will hamper Robin, but I think people were pissed. And that's a very reasonable reaction, and we knew that this was going to be a tough outcome, it was a tough decision for us to make internally, and a big part of that was because of the impact we knew we would have on patients, and especially on those sites that were already involved with patients. So our team has done a really great job of managing that as best as we can in a tough situation. As far as Robin enrollment goes, we're managing those interactions with potential sites very rigorously and in a very detailed fashion. And we're ensuring primarily that these oncologists and the collective team, including surgeons and including the gastroenterologists, are on board with the idea of giving something that is very novel in this setting and understand that there's ultimately a huge benefit that we're going to be able to unlock the patients with their support and their recognition and rigor in executing the trial. So we've not experienced, what I would say, significant resistance because of the Batman outcome, and we're being really thoughtful and rigorous in how we're selecting the sites for Robin to make sure the trial is conducted in an efficient and scientifically rigorous fashion. Yeah, we want to give people the drug, right? And the same thing, like, compassionate use of programs makes scientists mad because we just want to do the damn trial. But like, we do it at the end of the day. We just want to get people this drug. Yeah, and we want get the drug to patients. And we've really tried. We have a very strong medical affairs effort around education so that everyone has at least a chance of knowing the information and being able to make an informed decision about .. Hopefully, you know, capital constraints are... One day we open the world. That's part of this group's job. Yeah. All right, well, great. Zach, Dr. Sutton, thank you guys for a great discussion here. And following us right now is Abigee. Thank you.