Candel Therapeutics, Inc. ($CADL)

Good afternoon, and welcome to the Candel Therapeutics conference call, where the company will be discussing extended follow-up data from the Phase III clinical trial in patients with localized prostate cancer following an oral plenary presentation at the 2026 American Urological Association Annual Meeting with subsequent Q&A from Candel management and their guests, thought leader physicians. [Operator Instructions] Please be advised that this call is being recorded. You can find information on a replay of the call and further information related to today's announcement on the Candel Therapeutics website at candeltx.com. At this time, I would like to turn the call over to Ted Jenkins, Vice President, Investor Relations and Business Development at Candel Therapeutics. Mr. Jenkins, please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us on today's call. Earlier today, the company presented extended follow-up data from the Phase III clinical trial in patients with intermediate to high-risk localized prostate cancer during an oral plenary presentation at the 2026 American Urological Association Annual Meeting in Washington, D.C. We are pleased to conduct a public follow-up call sharing insights and provide an opportunity for Q&A from management and our expert prostate cancer specialists. Before we begin, I'd like to remind everyone that we may be making forward-looking statements during this call with disclaimers to such statements published within this presentation and also on our website, including, without limitation, statements regarding Candel's future business and development plans, expectations regarding potential efficacy and commercial potential of Candel's product candidates, expectations regarding the submission of the BLA for aglatimagene and expectations regarding the therapeutic benefit of the company's platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties I've described here and those described from time to time in our SEC filings. Our results may differ materially from those discussed on today's call, and we undertake no obligation to update statements regarding the future or to confirm these statements in relation to actual results unless required by law. Joining us on the call today from the company to discuss these results are Dr. Paul-Peter Tak, our President and Chief Executive Officer; Dr. Garrett Nichols, our Chief Medical Officer; Dr. Francesca Barone, our Chief Scientific Officer; Sue Stewart, our Chief Regulatory Officer; and Seshu Tyagarajan, our Chief Technical and Development Officer; and Charles Schoch, our Chief Financial Officer. We're also pleased to introduce the following prostate cancer thought leaders: Dr. Steven Finkelstein, National Director of Radiation Oncology at USUP, Director of Radiation Oncology Research at AMP; Dr. Daniel George, Professor of Medicine, Surgery and Urology at Duke University School of Medicine, Director of Genitourinary Oncology, Duke Cancer Institute; and Dr. Neal Shore, Medical Director of Carolina Urological Research Center. Following the prepared remarks, we will open the line for questions for Candel management and our guest speakers. With that, I'd like to now turn the call over to Candel's CEO, Dr. Paul-Peter Tak. Paul-Peter?

Thank you, Ted, and thank you all for joining us this afternoon. We are pleased to reflect on the extended follow-up results from our Phase III clinical trial of aglatimagene besadenovec or aglatimagene in intermediate to high-risk localized prostate cancer. And we are honored that this updated analysis was selected for oral plenary presentation at this year's AUA Annual Meeting in Washington, D.C. The treatment goal for [ man bit ] intermediate or high-risk localized prostate cancer who elect to undergo vertical treatment is the elimination of the tumor and the prevention of cancer recurrence. In these patients, local control is crucial because of the known increased risk of local regional disease progression, metastatic disease,and prostate cancer-related mortality after prolonged follow-up in patients with positive prostate biopsies at least 2 years after medical therapy. In addition, after tumor recurrence, [ salvage ] anticancer therapies, including long-term ADT, are associated with side effects and impact quality of lives. There's still a significant unmet need, as around 30% of the patients will develop recurrent disease despite medical prostatectomy or radiotherapy. Therefore, we aim to assess whether our investigational immunotherapy, aglatimagene, first valacyclovir, which is a prodrug, then added to standard of care radiotherapy could reduce the risk of prostate cancer recurrence compared with placebo without adding significant toxicity. If successful, aglatimagene could potentially improve disease outcomes and reduce the need for [ salvage ] anti-cancer therapies. In December 2024, we reported that our Phase III clinical trial in patients with intermediate to high-risk localized prostate cancer demonstrated statistically significant improvement in the primary endpoint of disease free survival in patients who received aglatimagene plus [indiscernible] combined with standard of care valuation therapy compared to those who received placebo plus standard of care radiation therapy. This finding was supported by secondary endpoint results. Of importance, aglatimagene significantly improved the rate of pathological complete response in 2-year biopsies compared with placebo, suggesting the cancer had been eradicated at a microscopic level. Although [ 2G biopsy ] is not part of standard clinical practice as it is an invasive procedure, it has previously been used as a gold standard research tool in clinical trials of radiation therapy with curative intent. Histologic detection of cancer represents an early and objective measure of disease recurrence and precedes clinical evidence of recurrence after extended follow up. The results presented today at the AUA Annual Meeting are consistent with this premise and show emerging trends suggesting delayed biochemical failure, metastatic disease, and need for salvage anticancer therapy in the aglatimagene arm versus placebo in patients treated with standard of care radiotherapy with curative intent. Dr. Nichols will present this data in a minute. It's important to note that the Phase III study was conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration, the FDA. We've also received Fast Track Designation, and subsequently, Regenerative Advanced Medicine Therapy designation, RMAT designation in May of last year, post the Phase III data. We are planning to file our biological license application, BLA, in Q4 of this year. If approved, aglatimagene immunotherapy could represent the first new therapy for men with localized prostate cancer in over 20 years. Garrett, over to you to discuss the data presented earlier today.

Thank you, Paul-Peter. I'll now walk through the AUA presentation made earlier today in Washington, D.C. of our extended follow-up data from our Phase III clinical trial of aglatimagene in patients with newly diagnosed intermediate to high-risk localized prostate cancer. There's a large and growing population of men who are diagnosed with localized prostate cancer every year in the United States. Over 40% of these men with intermediate to high-risk disease choose radiotherapy with curative intent. The ultimate goal of these patients is to treat their cancer and to keep it from coming back, while minimizing treatment-related side effects and maintaining their quality of life. Because despite standard-of-care radiotherapy, 30% or more will recur and will require salvage therapy. Aglatimagene plus this prodrug valacyclovir is a novel investigational multimodal immunotherapy that enhances the effects of radiotherapy with curative intent. Aglatimagene is a replication-defective adenovirus construct that encodes the thymidine kinase gene derived from HSV. After intraprostatic injection, aglatimagene delivers that gene to tumor cells, which, in turn, express HSV-tk, thymidine kinase. Aglatimagene is administered in combination with an oral prodrug that is converted by the enzyme into a toxic nucleotide analog at the site of the tumor. Meanwhile, radiotherapy delivered to the prostate damages DNA, activating DNA repair mechanisms. The nucleotide analog produced after aglatimagene plus prodrug treatment blocks DNA synthesis in dividing tumor cells or those undergoing repair, leading to immunogenic tumor cell death and release of tumor antigens. Adenoviral capsid proteins attract and activate immune cells in the tumor microenvironment. And together, we believe this results in a specific antitumor immune response. Aglatimagene is injected into the prostate in a simple outpatient procedure. Ultrasound guidance is used to inject 2 [ mils ] transrectally or [ transparent nearly ] using a small 20 to 22 gauge spinal needle into the 4 quadrants of the prostate. This results in broad distribution throughout the gland. The 3 injection schedule is synchronized with radiation therapy and allows 14 days of valacyclovir dosing after each injection. The first injection, approximately 14 days prior to the start of radiation, may be performed the same visit as fiducial markers and potentially space replacement. The second injection is administered at the time of radiotherapy initiation. And the third injection is administered approximately 14 days later, again, to facilitate 14 days of valacyclovir dosing. The Phase III clinical trial of aglatimagene enrolled 745 patients with localized intermediate to high risk with 1 high-risk feature prostate cancer and randomized them 2:1 to 3 injections of aglatimagene plus prodrug versus 3 injections of placebo plus prodrug, both in combination with standard-of-care radiotherapy with or without short course ADT, androgen deprivation therapy. Randomization was stratified by NCCN Guideline Risk Group and the planned use of ADT. The primary endpoint was disease-free survival with key secondary endpoints, including freedom from biochemical failure and prostate cancer specific outcomes. The disease-free survival endpoint was designed to capture a treatment effect in early localized prostate cancer. It captures the patient's goal of living free of cancer. Disease-free survival is the date of randomization to the date of prostate cancer recurrence proven by biopsy, clinical or radiographic evidence of local or regional failure, distant metastases or death from any cause. DFS as a primary endpoint was a key element of the SPA agreed with the FDA. Prostate cancer specific DFS is a key secondary endpoint and is defined as time from randomization to prostate cancer recurrence, metastasis or prostate cancer-specific death. The randomized population in the Phase III trial was well balanced in terms of baseline characteristics. The median age of the population was 69 years with a good representation of Black and African-American patients. Approximately 85% had intermediate risk prostate cancer and had baseline [ lesion ] score of 7. Nearly half planned to use short-term ADT. The updated trial results as of March 15, 2026, presented today after a median follow-up of 58 months showed that aglatimagene significantly improved prostate-specific disease-free survival by 39%. Only 2 deaths due to prostate cancer were recorded over this follow-up period, as expected for this population and duration of follow-up. In the ITT population, there was a longer time to salvage anticancer therapy, which is the Kaplan-Meier shown on the left, and the time to biochemical failure, the Kaplan-Meier shown on the right observed in the aglatimagene arm. Both hazard ratios were 0.72. Again, in the ITT population, there was also a lower incidence of an increased time to metastasis that was observed in the aglatimagene arm. Next, we examined these endpoints in the subset of the intermediate risk population, which again represented 85% of the patients enrolled in the trial. In that subset, aglatimagene improved prostate cancer-specific disease-free survival after extended follow-up by 41%, which was highly statistically significant. In the intermediate risk subset, aglatimagene also reduced the time to salvage anticancer therapy, the Kaplan-Meier on the left, by 49% and the time to biochemical failure, the Kaplan-Meier on the right, by 52%. And finally, in the intermediate risk subset, metastatic disease developed at a low rate of 0.24% in the aglatimagene arm versus 2.35% in the placebo arm. The time to metastasis had a hazard ratio of 0.1, which suggests 90% improvement and was statistically significant. Aglatimagene in combination with standard of care radiation with or without ADT was generally well tolerated. SAEs and treatment discontinuations were numerically lower in the aglatimagene arm than in the placebo arm. The most common treatment-related adverse events were chills, fever and flu-like symptoms experienced in about 1/3 of the patients. These were all low-grade and self-limited. So in conclusion, we showed evidence of accumulating clinical benefit in patients treated with aglatimagene in combination with EBRT after extended follow-up. Our previously presented primary endpoint demonstrated statistically significant improvement in DFS as well as increased pathological complete response in 2-year biopsies, which are known to be predictive of subsequent biochemical failure and metastasis after 10 years or more of follow-up. Consistent with these earlier findings, our extended follow-up presented today demonstrates delayed biochemical failure metastatic disease and the need for salvage anticancer therapy in the aglatimagene arm versus the placebo arm. These clinical benefits were not observed to be associated with additional significant toxicities. And if approved, aglatimagene could offer a new treatment option that may help men live longer, free from prostate cancer recurrence and the need for cancer -- salvage anti cancer therapy. Thank you very much for your attention, and I'll hand it back to Paul-Peter.

Thank you, Garrett, for reviewing the data. Before we move on, I want to take this opportunity to thank the patients, their families and caregivers, our clinical collaborators and advisers who participated in our clinical trials, as our team and shareholders. We recognize the immense effort it takes for patients to participate in such studies with the hope of improving not only their own outcomes, but also the outcomes of future patients. None of the progress we make as drug developers would be possible without their participation and support. And we are truly inspired by our partnership with patients. I also want to thank our dedicated employees at Candel and acknowledge their relentless pursuit of excellence. To our loyal shareholders, we thank you for your trust and support and look forward to our continued partnership when we advance our programs. With that, I would like to introduce you to Dr. Steven Finkelstein, Daniel George and Neal Shore, who will briefly share their background and discuss what these findings mean for patients. And next, we will open it up for questions. So Dr. Finkelstein, maybe you can introduce yourself, your background and share your thoughts about these findings?

Thank you so much. My name is Steven Finkelstein. I'm the National Director of [ Radiation Oncology ] for U.S. Urology Partners and the Director of [ Radiation Oncology ] Research for Associated Medical Professionals. It's been an interesting journey for me. I cut my teeth as a immunotherapist and a surgeon under Dr. Steven Rosenberg at the National Cancer Institute. For that work, I won the Presidential Award at [ SITC ]. I have worked with and been involved with immunotherapies for cancer and have always wanted to see data that showed radiation therapy working with an immunotherapy, a novel immunotherapy that could help patients in prostate cancer. So putting a personal reference, my father, Howard Finkelstein, was diagnosed with high-risk prostate cancer. After reviewing all his options, which included surgery and radiation therapy with androgen deprivation therapy, he chose radiation therapy with ADT, was treated, and he was one of the fortunate ones who were cured and lived 12 years before he ultimately passed away. And I miss him very much. Not everyone is so lucky. About 1 in every 3 patients with that problem will have [ gage ] cancer come back. It is desperately needed to have therapy that could help patients with cancer. Indeed, at the beginning of this AUA meeting, the AUA Secretary opened the AUA meeting with a call to challenge the norm. I will quote, "Many of the lectures in the panel -- many of the lectures and panels on the plenary session will question and explore current standards of care and push attendees to reconsider long-standing practices." I believe that's what we have seen today out of this set of data. We are seeing a novel immunotherapy approach in a plus 1 regimen that adds to the standard regimen of radiation therapy being able to help patients across almost every outcome, including the primary endpoints. This is remarkable. I believe this to be transformative for the practice of radiation therapy as a card-carrying radiation oncologists and immunotherapist. This is what we have been waiting for 20 years. I think that the data presented today at the AUA will be something that we talked about in the same way as KEYTRUDA was when I was on the podium as discussing 3 days after its approval. I had told the field of radiation oncology at [ ASTRO ] that KEYTRUDA would be transformative in the field. And now we, years later, probably don't imagine a world that immunotherapy is not pervasive. This changes the playing field. With that, I'll stop, and I will defer to my colleague.

Yes. I'll just say this, Dr. Finkelstein. I want to thank you for sharing not only your scientific and medical insights, but also a very personal story here. So over to you, Dr. George. Please share your background and your thoughts about the data that we've shared today.

Yes. Can you all hear me okay?

Yes.

Yes, great. This is Dan George from Duke. I apologize for calling in remotely here. But thank you so much for the opportunity to speak. I'm a medical oncologist. I've been in practice for 27 years. I lead the GU Oncology Group here at Duke and Professor of Medicine, et cetera, et cetera. From my perspective, for our patients -- and I'm in clinic today seeing them -- the #1 thing for patients that they want to avoid is hormonal therapy. Patients will choose surgery over radiation and hormonal therapy simply for the fact to avoid hormonal therapy and the life-altering effects. Now I understand this data is with without hormonotherapy, but the real benefit here will be for patients that have intermediate risk disease that we're concerned will have a risk of residual local disease. And as you can see in our control arm, that exists. The fact that we see that change right off the bat, and that correlates with these longer-term clinical outcomes of relapse-free survival and even metastasis-free survival is really important. That really, I think, in many ways, validates that this local residual disease is the driver of this disease progression in the future. And getting better local control now is really critical. And there are other studies that are out there examining hormonal therapies and more intensified hormonal therapies. But that's not what patients want. What patients want is just like what you heard, they want to have their anatomy intact and they want to be able to treat this cancer without treating their whole systemic body with therapy. That's what this does. This is a local, [ focal ] therapy that then has a systemic effect associated with it. In many ways, it's the best of both worlds. And the injections, although they sound kind of complicated and everything, that is a routine practice in urology and radiation oncology. And it's something these patients are routinely undergoing with fiducial marker placements and other things. So this is not a burden, an outsized burden on the treatment plan. This is something our patients are going to very much appreciate and gravitate to. And it's going to get more patients off the fence between surgery or radiation.

Thank you so much, Dr. George. We may come back to that last point later on. So let's move on to Dr. Shore. Maybe you can introduce yourself, your background and share your views on what was presented today at the AUA?

I'm Neal Shore, I'm a uro-oncologist, been doing clinical trial work for several decades now. We were part of the clinical trial. We had a very favorable experience from a local standpoint. My current radiation oncology partner, I think, put more patients on the trial than anyone else in the country. We plan to do some follow-up work on patient-reported outcomes and follow those patients as well, and I'm excited about that. I'll echo the comments of Drs. Finkelstein and George in that -- and as somebody who actually administered product, it's very simple. The 20 to 22 gauge needle is on the relatively small side of the types of transperineal and transrectal devices we use. So patient tolerability is particularly good. The 4 quadrant approach is very, very simple. It's not particularly complicated. Taking the oral valacyclovir is extremely well tolerated by and large. And I think the mechanism of action is elegant, it's complicated, it's immunobiologic. And really, I think the bottom line there, where radiation technology lends itself so well as to radio sensitizers. And as Dr. Finkelstein knows and the whole field knows for many, many years, they've really been very wedded to testosterone suppression. And so if there's an ability to avoid that, certainly, we reduce the testosterone suppression side effect profile. That's -- those are sort of practical and patient-centric issues. The fact that we now have this very nice long-term data, this is a very long prospective trial that you have pathologic CRs that best the placebo arm, that you have diminishment and BCR as well as metastases, that just sets off a whole cascade of other therapeutics, either oral or parenteral, which do cause side effects, do impact patient quality of life. So I'm just sort of recapitulating the data that you heard, the comments from Drs. Finkelstein and George. And I do think that this is certainly going to add to, if approved, the rigor of conversation that we have with patients regarding the very important aspect of shared decision-making. We keep growing our number of options for patients, and this is clearly a very unique and novel approach.

Thank you very much, Dr. Shore. So before we open it up for questions from analysts, I would like to ask the key external experts on this call a few more questions. So maybe first to Dr. Finkelstein. Could you elaborate on how this would fit in the radiation oncology workflow, a patient is diagnosed with intermediate or high-risk localized prostate cancer. So what does that look like in clinical practice?

Yes. So I think how it integrates into radiation oncology will be pretty seamless. We are very used to using fiducial markers, as my colleague, Dr. Shore said, in spacing device. This will be very usual for a radiation oncologist who does it. And it will also be usual for working with urologists because I see that if we add 1 more injection into the mix, that this is something that will be picked up upon not by just my specialty in radiation oncology, but working closely with partners in my group at U.S. urology, partners at AMP to have urologists be able to do this for those radiation oncologists who don't want to do the procedure themselves. When that happens, I think that patients will be enticed by the idea in significant prostate cancers about doing something to help them improve their outcomes more so than what we have currently done. It's hard in the clinic as a radiation oncologist to say to a patient that the therapy that we're going to give only works 2/3 of the time. The same is true for surgery in this situation. But for the first time, we have data, Phase III data that shows an innovative immunotherapy approach, a multimodality approach can actually improve across a large number of outcomes. From my own father, this is something that I would have brought in front of him, and he would have most likely said yes, sign me up. So I think this is something, again, very exciting. I believe 5 years from now, we'll be talking about how this is just the normal way we treat patients with radiation therapy.

Thank you very much. I want to turn to Dr. George. Maybe you can share your thoughts about shared decision making, the choice to undergo radical prostatectomy versus radiation therapy? So how do you look at this also from a more medical oncology perspective?

Yes, thanks. I think the real issue when we talk with patients with localized disease, whether they're intermediate, unfavorable intermediate or favorable high risk, these are patients that have a life expectancy from prostate cancer that hasn't reached the median. What do I mean by that? Half of those patients are not going to die of prostate cancer. More than half are not going to die of prostate cancer. Most of these patients are going to die from other causes. There's a small percentage, and it's probably somewhere in the sort of 20% to 30% range, that at 15 years, these patients will die of prostate cancer. So we're treating patients to prevent death from prostate cancer 15 years or more down the road. That's not a given at all. This is not pancreatic cancer or brain tumors, right? So the perspective here is focused on a quality of life goal. And that's really important. That's why we do the shared decision-making because we really need to understand for the patients, just how aggressive they want to be, how definitive they need to be, how comfortable they are with the different approaches and side effect profiles. And because a lot of men are diagnosed in the 60s and 70s and even 80s, we are looking for ways of nonsurgical approaches. So the use of radiation has increased in this country over the last few decades. And I think, as I mentioned earlier, the biggest thing holding it back is the hormonal therapy. And to be honest with you, my biggest concern isn't the surgery or the radiation, it's the effects of hormonal therapy on these men because that is essentially what ages them. Within 4 months, we can see men lose muscle mass that's equivalent of 10 years of aging. I mean, that's remarkable, and it's something we don't measure well, but people feel it and they complain about it qualitatively. So -- and people talk. Someone gets prostate cancer, they start talking to their friends who have prostate cancer and people start telling the woes of hormonal therapy. So it's why patients come to us concerned about this. And frankly, as a medical doctor, I'm concerned about it. So to me, this is really -- I mean, I think, as I mentioned, I think a great breakthrough for the patients that we don't necessarily need to use hormonal therapy and we can improve the outcomes, as Dr. Finkelstein mentioned. But it's also going to be applicable for the patients who we do need to do hormonal therapy in. Because in my mind, the biggest use of hormonal therapy in these patients is really to get more of a complete response in the primary tumor. Many of these patients have bulky disease, and decreasing that with hormonal therapy helps us get a more complete response to radiation. The smaller the tumor, the better the radiation. This medicine allows us to do that, but it also allows us to get an immune response, which is really now, a very validated approach and something that patients are very comfortable understanding. 10, 15 years ago, it might have been a hard sell to explain to patients what immunotherapy is. Now it's all over the news. People know that is the latest breakthroughs, and it's something we don't use routinely in prostate cancer. So it's a great opportunity to offer a new modality of therapy and to give patients an approach that doesn't add to the side effect toxicity or to that systemic deterioration, muscle loss, et cetera, that patients experience with even short-term hormonal therapy. But if we can take 2 years of hormonal therapy down to 6 months by using something like this, those are the kind of things that are going to really change practice. And I think this would -- as we mentioned, I think it has every reason to catch on pretty quickly for patients based on this data.

That's very helpful. Thank you very much. Dr. Shore, maybe you can elaborate a little bit on the procedure, right? So what does that look like? How complex is it actually to inject it into the prostate? How does it compare to the standard of care diagnostic biopsy [ but is ] the urology workflow in this basis? So maybe you can help us understand how this works in clinical practice.

Sure. There's option to go via through the rectal wall transrectally, which is sort of a long-standing approach by many urologists and many radiation oncologists. More recently, there's been a move towards a transperineal approach. Historically, we used to do a lot of our transactional approaches, the biopsies, and would give literally no topical anesthetic. Seems barbaric, but that was the state of the art. Today, virtually everybody should be getting some sort of perirectal transperineal periprostatic local injection of an anesthetic. So why is that important? Well, it's important because you can do these in really every clinic in the world. You don't need to have an elaborate outpatient surgery center facility. If you have one and you wanted to do it there, that's fine, too. It doesn't [ obligate ] one versus the other. The practical aspect is that for urologists, they're very, very comfortable in doing transperineal and transrectal ultrasound-guided procedures. It is really on the order similar to doing a needle biopsy, which is pretty much the bread and butter of most general community-based urologists. So I think the long -- the short answer is that the technical expertise to do this, there really is no additional technical expertise. It's rather quite simple. And as I said earlier, the needle gauge is very small, which makes it that much more comfortable regardless if you're doing it through the rectum or through the perineum.

Thank you very much. So I have many more questions that I could ask you, but I want to make sure that we give the analysts first, the chance actually to ask their question. So operator, over to you.

[Operator Instructions] Our first question comes from the line of Yigal Nochomovitz of Citigroup.

I guess this is a bit of a follow-up to Paul Peter's question. I mean obviously, the Candel study wasn't done against surgery. But for the physicians on the panel, I'm wondering to the extent possible, if you could put this data in perspective relative to DFS, DCR and risk of metastases relative to what you'd expect with a surgical approach in a similar patient population, especially when you're engaged in the shared decision-making with patients who may have for whatever reason, a stronger preference for the surgical option?

Thanks for the question, Yigal. So maybe Dr. George, maybe you want to start?

Yes, happy to. Yes, great question. And it's not -- that's not this study, but it's a very relevant question when we're in front of patients talking about these results. And when you look at the relapse-free survival rate, it's a little bit complicated because it includes this biopsy, which we typically don't do in practice. But even if you take those biopsy defined populations and include them, we're still looking at a relapse-free survival rate that's pretty comparable to what we'd expect with surgery. What I think is really fascinating is the metastasis-free survival rates that we're seeing. And I think, obviously, we want to see longer data. But this is ultimately the goal, is to prevent this disease from metastasizing because that's when we really need to use hormonal therapy. For many of these small biochemical relapses and stuff, we'll follow those patients. We might find a lymph node that we can radiate further and whatnot. So the real goal is to prevent that metastatic disease. Now with PET scan, we're picking up these microscopic sites or previously microscopic sites of disease earlier. So there's lots of ways to intervene. But being able to prevent that relapse-free survival or maintain that relapse-free survival at these rates, I think, is very comparable to what we'd see. It's just hard to quote any specific population because every trial is a little bit different in the patient population that's accrued, how many were high-risk, favorable high risk, intermediate or unfavorable intermediate and whatnot. And that's why we do randomized trials. So I think those may be future questions. But right now, just on looking side-by-side, study to study, these results are very comparable.

Yigal did that answer your question? Yes, go ahead.

Yes. No. Could I ask a follow-up? Or if the others wanted to comment as well.

Let's hear the additional comment.

I was going to add, as a radiation oncologist, for these problems in prostate cancer, patients see both the radiation oncologists and the surgeon and are told that both of these approaches as they have existed are equal, equal, equal in outcomes. There has never been a prospective, randomized, reproducible data that has shown one is better than the other. So now we have data from this trial, a Phase III trial that shows adding an agent, a plus 1 agent to what we do in radiation therapy improves upon what we do in radiation. That's very provocative. So again, as a radiation oncologist, we're going to view this as something that goes beyond what we have currently told patients with respect to radiation by itself with ADT. What that means in the future, we'll have to see. But this is extremely exciting when thinking it from a radiation oncology perspective.

Thank you. To make sure that we hear the whole perspective from everybody, Dr. Shore, do you want to add anything?

Yes, I'll be very brief. You really can't make comparisons that, that was not the study design here. So let's be very clear about that. Results that are obtained from different radiation oncology centers as well as different prostatectomy, surgical extra patient centers, they vary based upon site and the specific physician. There's a range. And that's sort of the beauty that patients have to -- the ability to make their choices. If I had to just sort of generalize, at least in the arc of my career, over the last 5 to 10 years, the amount of prostatectomy being done in intermediate-risk disease has decreased, being more relegated to the high-risk patients. Not to say that radiation hasn't decreased in that group at all. We've actually gotten more involved with combination of systemic therapies, androgen receptor pathway inhibitors or biosynthesis inhibitors, as well as testosterone suppression. So I think what's particularly exciting about the data is the potential for future studies and how to think about optimizing this combination therapy, this immunobiologic with either a very short-term dose of testosterone suppression. Certainly not as long as what we're used to doing, but that's data that remains to be seen.

Thank you very much. Back to you, Yigal. You have additional questions or follow-up question?

Well, my other one was more of a, I guess, a forward-looking question in terms of -- you mentioned some of the panelists mentioned the shift towards radiation away from surgical options in the United States. And I guess, I know it's hard to predict too specifically, but just -- could you comment a little bit as to how this novel technology from Candel, would you expect it to further enhance that shift away from surgery toward radiation? And if you could comment, currently in your respective institutions, what is the current split in the localized prostate cancer between the 2 options [ today ]?

Who wants to start?

I can start. This is Dan George. So look, I mean, I think that as Dr. Shore mentioned, there's going to be wide variation in practice patterns out there in patient populations. But I would say if we're going to generalize, our younger patients are still going to be attracted to doing surgery. And the reasons are surgery is and will be the gold standard. If you think about all of our solid tumors that are localized, we start with surgery. It doesn't matter if it's breast or colon, lung, surgery is the mainstay of how we control that local side of disease and it gets us more information about the tissue, but most importantly, gets that primary out, essentially removes the root of the disease. And that's going to always be the case. But the truth of the matter is, is because this is such an indolent disease, that can -- people can live with for many, many years, much more so than many of those other cancers I mentioned, that there becomes a point in life where alternatives to maintaining your anatomy become even more important than all the information and peace of mind to having it out. So those are the kinds of shared decision-making discussions we have. We have some men that are older that still want it out, and that's always going to be the case. It's fine. But I think there's also going to be some men who really want to preserve their anatomy. And the more data we have to show that we can do that in a way that doesn't expose them to the systemic effects of hormonal therapy and allows us to get this complete response. And that's essentially what you're seeing with these biopsies at a higher rate with this approach. It's going to tip it. It's not going to -- we're not going to see a seismic shift, but I think it will tip the radiation trends even more in that favor. And we're getting better and better at our technology with radiation and things like that. It's not that surgery has gotten worse. It's just that we're getting more and more effective in our forms of radiation delivery and whatnot. So I think that's why you see some of those trends over time. But there's always going to be both in the field.

Dr. Shore?

Well, it's interesting comments from Dr. George. I don't totally agree with the comment about younger men always leaning towards prostatectomy. I can't believe I'm a surgeon contradicting the medical oncologist who is trying to push for more surgeries. The radiation technology has gotten so good. That's incontrovertible. Some of the folks question -- and I think the long-term safety, but the risk of long-term [ sequela ] on the bladder and on the rectum, we have characterized that very well. And that has -- from radiation, but it also has to be balanced against removing the prostate and the impact on sexual function and urinary function over the course of time and for younger men. It's a hot topic of debate. We're going to have next year, a really good conference, I'll promote it, the Localized Prostate Cancer Consensus Conference. It's an offshoot of the Advanced Prostate Cancer Consensus Conference. That will be in Lugano. And so we will have these very healthy debates about this. And I think it's really good for the field. I think where the Candel trial and their platform is going to be particularly provocative is for all the reasons that you just heard. So whether is it less than 50, over 50, over 60, over 70, 80, we still have this very healthy debate even amongst our surgical [ prostatectomists ]. So -- as well as our radiation oncologists. I think it's healthy. I think it's very good. I look forward to the company figuring the next set of trial design that they want. I know there will be a lot of interest now from many of the sites who were not part of this really pioneering work.

Well, thank you very much. I propose that we go back to the operator to take the questions on the next analyst.

Our next question comes from the line of Imogen Mansfield of Cantor Fitzgerald.

Congratulations on the update, and thanks for bringing such a great selection of KOLs on to the call. It would be very helpful to hear the doctors on the call talk about the degree of benefit that we're seeing and putting that into perspective for your patients of how important this 0.61 hazard ratio for prostate cancer-specific DFSs for them. And then I have a follow up.

Thank you very much for the question. Who wants to start? Dr. Finkelstein?

Sure. So I will say this is my 29th year in doing surgery and then radiation oncology. For 20 years, we have not brought a single thing in this group of patients as a new therapy. The fact that we have Phase III data across intermediate risk and high-risk patients is, I believe, again, transformative. I believe the data to be significant. If we don't believe Phase III trials, why do we do them? And so you have data in the intermediate risk and the high-risk space. That means the endpoints that were set forth by the study in looking at it with experts, when looking at it with the FDA about what -- how to build a study. If we don't believe Phase III trials, why do we do them? And I think that this has been an approach that has gone for the data when it goes back now almost a decade, shows that this kind of approach goes from preclinical to clinical, it takes so long. And we get to this point and we look and somebody stands up at the AUA and says, look, there's a positive Phase III trial. I think we need to embrace that strongly.

Did that answer your question, Imogen?

Yes. I guess just specifically around the sort of degree of benefit, is that something that patients would find appealing as they kind of seeking sort of intensive therapy as possible? Or I guess, as patients discuss ADT as an option with you in clinic, and this being similar in the degree of benefit, how do you see them viewing something like [ CAN-2409 ]? Well, viewing aglatimagene?

Yes. This is Dan George. I can follow up on that, too. So look, I think patients are going to be extremely excited about that result. I mean, if you can decrease the relapse rate by 40%, I think patients would be excited about a 20% decrease in relapse rate. A 40% decrease in relapse rate is really important. Look, we're not going to be seeing overall survival, right? This is too far along an endpoint in everything. What patients care about most is the cancer going to come back. That's the immediate endpoint. And that's what we're showing here. And that's a pretty dramatic effect. And patients say, look, I'm not on treatment for years with this. It's something that's built into my regular workflow, as you heard. I take this extra pill just while we're going through it. And that's it. I mean, this is a low lift for the patient. And what I would see is a much greater overall relative benefit even maybe what we see with hormonal therapy. So yes, I think patients are going to be very excited about that.

Thank you very much, Imogen. Any other questions?

Yes. I was wondering if you could share the total number of events that happened in each arm at the new data cut?

Maybe, Garrett, that's a question for you?

Yes. I don't have the total number of events in each. I think it's 127 total events for the prostate cancer specific outcomes. We can get back to you as far as that number is concerned.

Thank you very much. So I propose that we go to the next analyst. Operator?

Our next question comes from the line of Oliver McCammon of LifeSci Capital.

Congratulations on today's update. For the external experts on the call, we heard some discussion on potentially sparing patients hormone therapy. Assuming 2409 is approved, do you think ADTs could shift among the intermediate and high-risk patients electing to receive radiotherapy? How would this potentially fit into NCCN guidelines? And then can you remind us what's attractive about avoiding ADT? Sorry for all the questions.

Thank you very much, Oliver. Dr. George?

Yes. Dan George. So I'll answer the second one first, and maybe Dr. Finkelstein can talk a little bit about the context in radiation therapy. But from a patient standpoint, hormonal therapy is -- it's a life-changing effect. Look, I mean, in a word, this is sort of like male menopause. And it's something that hits quickly. We drop testosterones within days. It's something that affects people from head to toe in terms of everything from mood swings and irritability to hot flashes to loss of libido and motivations to [ my outages ] and muscle aches and joint aches. But more importantly, we're having metabolic changes that are happening in these patients over a 1- to 3-month period of time that can be permanent in many of our patients. I mentioned the muscle loss and there's bone loss, increased osteoporosis, but there's a metabolic syndrome where patients gain this sort of body fat that actually almost functions like an endocrine organ. I mean, this is causing increased lipidemia, increased glucose intolerance and diabetes. We see hypertension, we see increased risk of stroke and heart attack. I mean, we're accelerating for what is already happening in many of our patients, their comorbidities. And this is a really critical thing here, is that we end up not just dealing with prostate cancer, but dealing with all these other medical issues that now have intensified because of the hormonal therapy. And when we stop it, it doesn't reverse. We've shrunk the testes down. We stopped the medicines, the testes is still shrunk. It takes months for those things to recover, and usually only about halfway of the testosterone. And by the way, with all the loss of motivation and everything else, these patients don't gain their muscle mass back. It doesn't happen passively. They have to get out there and work hard and do it and diet and exercise. And most of America isn't doing that. So that's the struggle that we have. And that's why this is so important. I can't really overestimate just how important the avoidance of hormonal therapy is. We give that medicine very reluctantly in this setting, but it's because the only thing we've had to enhance the radiation therapy effects. Now we have something else.

Dr. Finkelstein?

I think as -- Steve Finkelstein. I think Dan summed it up very well. The elephant in the room is that every single cancer patient that I see in clinic does not want to be on androgen deprivation therapy. Nobody does that recreationally. Hope you guys laughed at that joke. My mentor used to say, what profits wisdom, if nothing can be done? We didn't have any other alternative, and this worked, then that was the choice. Today, data presented at AUA and ultimately presented in paper form shows that there will be another agent in this space, the first one in probably 20 years. And that will be the elephant in the room. And I think for radiation patients, of which we see every one or should see every single patient in the intermediate risk and high-risk space, as surgery and radiation are felt to be equal in outcomes, this provides an opportunity to be able to use an innovative approach, either with ADT for the right patients. And then ultimately, you'll see what happens later with respect to maybe without ADT as further data continues to develop. But I think that for the first time in 20 years, the ability to offer patients not what they -- patients come to radiation oncologists and are not worried about the radiation. They do radiation therapy now with technology that didn't exist. When I think about the computers you guys had 20 years ago, right? Now we have all these fancy things that allows us to do radiation planning and treatment. People are not worried about the radiation. People worry about the ADT, just like Dan said. And like I said, incredible day, I believe, for patients now with an innovative immunotherapy approach, that changes the playing field.

Dr. Shore, anything you want to add?

No, I think that was well said by Drs. Finkelstein and George.

Oliver, do you have any other questions?

Yes. One for the Candel team. You have a sizable presence at AUA this year. Can you walk us through how you're engaging with the potential trading community for 2409, how today's plenary presentation factors into the profile and then additional activities you have planned going forward in 2026 out of the BLA filing in Q4?

Yes, go ahead.

Yes, I'd be happy to address that. This is Garrett Nichols, Chief Medical Officer of the company. We're engaging with both the radiation oncology and the urology community here in a variety of different ways. Obviously, the presentation is key, but we're also meeting with folks one-on-one. We have a booth here at the conference so that folks can come up and meet and talk to us. We have also just several one-on-one meetings and opportunities to get people's feedback post the presentation that was made today. So we have a couple of more days here at AUA. We do plan to be active very much throughout the space and really look forward to hearing people's perspectives like those that were shared with the doctors on the line today.

Well, I have you on the line and our CSO as well. It's 5 minutes ago that Imogen asked about the number of events. Do you have them already?

Yes. Yes, we did we pull this up, Paul-Peter. And Imogen, the total number of events on the study as of the March 15, 2026 data cut was 147, 84 events on the aglatimagene arm and 63 on the placebo arm. Obviously, that's 2:1 randomization. So that's the reason for the delta.

Thank you very much, Garrett. And Imogen, I wanted to show how this team operates at a fast pace. So operator, back to you for the next question.

Our next question comes from the line of [indiscernible] [Operator Instructions]

Sorry about that. Congratulations on the presentation, and thank you for taking the time to host this call. So two for me. Maybe I wanted to follow up on -- from a guidelines perspective from the KOL panel. I guess, could you talk about a little bit more about where you see the initial positioning of 2409? Broad use in intermediate to high risk or a narrow recommendation for best intermediate patients or potentially just select higher-risk patients at first? And can you maybe translate that to how many patients you currently see? And then a second follow-up question would be, obviously, you guys are in the academic setting. Most of these patients are treated in the community setting. How should we be thinking about the delta in logistics between all the variables between office-based injection followed by radiation oncology? How -- where do you see the biggest delta in terms of streamlining this therapy between the academic setting versus the community setting?

Thank you. Maybe Dr. Shore, you want to start?

Well, I think that this will be, if approved, and certainly everyone is optimistic that it will, this will be very appealing to multidisciplinary care, whether you're just the radiation oncologist administering and conducting the radiation, or you're multidisciplinary, such as what I have in my clinic, as does Dr. Finkelstein, the urologist would probably administer the product, and the radiation oncologist, obviously, the radiation therapy. It's an obvious clear outpatient procedure. There's no new capital cost to get do the injection in terms of that technology. So yes, I think that, to your point, 85% of cancer care happens in community centers, not at academic centers. But they certainly do see as they do with Duke and other places, and they have radiation departments. And for all the reasons that we talked about avoidance of testosterone suppression with all the attendant [ sequeli ] that really most patients, if given their druthers, would opt out of that. I think it will be well received by the academic and the community radiation oncologists as well as the community and academic urologists.

Dr. Finkelstein?

Yes. And it's Steve Finkelstein. I wanted to -- I actually work in the community setting. So my background was, I was at National Cancer Institute. I was at an NCI-designated cancer center, and then I was stolen away to be the national lead for radiation. We are the largest freestanding urology group currently in the U.S. or U.S. urology partners. My personal practice is in Syracuse. I can tell you that I think the model that will take off will be bimodal. I think there will be a huge amount of urologists who want to do this and should do this in the way that they currently do spacing and fiducial markers. So everyone who knows how and facilitates this regularly to help radiation oncologists who don't do these kind of procedures is going to rock and roll with this in my mind. I agree with Dr. Shore completely. But I also think that it's interesting, as one who was a surgeon who became a radiation oncologist, while I'm happy to give this kind of stuff to my colleagues, I think this is going to create a new set of radiation oncologists who get more interest in it. A bunch of my friends within the field have been talking about this and how people who have -- who do brachytherapy or other things get interested in things they can add to their practices. So I think there'll be some markets that the urologists very much wants to be and will totally go head over heels with. I think there are other markets where the radiation oncologists -- for our friends at Candel, I don't think it matters that much. I think no matter where you are, someone is going to be excited about doing this within that market and those things will take care of itself. I do want to add one last thing that -- I don't want to speak for Neal, but being here at AUA, where this is a very busy meeting where everyone wants our attention, multiple drug companies. I'll have probably somewhere between 30 meetings in my time here. This is a group that actually, you want to meet with. And the team that they've put together is really incredible. And that team -- to the previous analysts who ask about what they plan to do, not everything they've done has been nothing but top shelf in engaging, I think, the key players within this. And like I said, we don't take our time -- I don't want to speak for Neal, but we don't take our time lightly to be in front of you today in a busy AUA meaning to do this. It has to be something of importance, and that's why we're here today.

Thank you very much, and I want to say that I really appreciate that. So time for one quick additional question, if you have one.

Sure. So it's exciting to hear about how homogenous kind of the uptake could be across the community in the academic setting. But just one point of clarification there. So would you expect that the identification for 25 -- for the best patients for 2409 would happen -- you spent some commentary when it would be identified, after biopsy, after MRI or after genomic testing. Do you find a bottleneck between academic and community settings where there -- the patient funnel between maybe intermediate and advanced will be identified using the same technique at the same stage? Any high-level thoughts on there would be also helpful.

I want to ask one of the external experts to speak to that. Who wants to take it?

I would say -- Okay. Yes, obviously just speak very briefly to the community setting. I believe there will be no issue. Essentially, we have a very, very robust flow in our community centers going from biopsy to genomic testing to [ PSMA pets ] in the correct settings, to seeing patients for both surgery and radiation. Our group is set up to see both surgery and radiation patients. At that point, seeing radiation oncology, we're going to talk about what the standard of care is. And a Phase III trial came today that says there's an additional thing for the standard of care. That means adding 1 more step, which is adding the ability to give this novel agent with it, we will most likely set that up with the urologists when they're doing spacing. And fiducials will just incorporate this. When this -- if this hits an FDA approval, we'll be ready to excel in it. I hope that's helpful to you.

Maybe I should add that in the clinical trial on the Phase III trial, actually, we had more patients who were involved in the community centers than in the academic centers. So I think it supports the view that this can be really easily implemented. So I want to go back to the operator to take the next question. I'm conscious of time. This is a great discussion, but I want to make sure that everybody can ask their questions.

Our next question comes from the line of Kemp Dolliver of Brookline Capital Markets.

At the risk of being repetitive, it seems the message I'm taking away with regard to the patient profile is that any intermediate or high-risk patient that presents to you is going to hear about this option alongside the other options.

Dr. George?

Is that a fair takeaway?

It is. It is. I mean, I think obviously, we're going to have to do some marketing and everything to get the word out there. But this is going to -- I mean, this is a high profile just at AUA, huge exposure there. And I think you're going to see a lot of the larger urology groups rapidly pick this up in practice, along with the radiation oncology groups. Let me clarify 1 other point that was asked a couple of questions ago about the -- about this particular indication. So this intermediate risk to favorable high-risk population probably represents about 30% of prostate cancers diagnosed today. If we're getting 300,000 cases of new cases of prostate cancer, that's a sizable population. And even if not all of those patients are getting radiation therapy, these are not patients that are doing active surveillance. So it's either surgery or radiation. So I think you're going to -- they have a large patient population to infiltrate right from the beginning. And it's the same set of doctors, the radiation oncologist, urologists that are going to be seeing those patients. And so I think this allows them to really integrate into that field and that practice very rapidly.

Kemp, any other questions?

No, that's it.

Back to the operator.

Our next question comes from the line of Sudan Loganathan of Stephens.

Hi, everyone. Thank you for this very excitable format. Great to hear from all the expert physicians as well on this topic. My first question for the experts is considering the assets' potential mode of administration, could you provide some color on how this potential could be viewed as invasive, defers from the prostatectomy procedure? And then like would this level be qualitatively identified between the two procedures?

Dr. Finkelstein?

Yes. So I'm going to put it in context as one who did surgery then did radiation oncology. So at NCI, I did some of the biggest surgeries in the world. I did whipples, I did retrograde lung perfusions. I did things that put patients in the ICU for multiple days after each procedure, and then they would go home after their cancer was managed in some degree. In prostatectomy, patients have the surgery that they have. I won't speak to that as a radiation oncologist. I think surgeons should speak to those things. But I will tell you that as radiation oncologists, we quote, that the rate of side effects of radiation therapy, any of [ our 2 ] is less than the risk of going to sleep for the anesthesia. So as a person who converted as an award-winning surgeon to become a radiation oncologist, our perspective is that our stuff is really not that exciting. I'm an outpatient specialty. I don't put patients in the hospital very -- because that's not what we do for prostate cancer and radiation. So now all you're really adding to this is an injection in this way that's really non-exciting. The patients, the biopsy is not fun because you're actually pulling stuff out of people. It's completely different than what we're talking about. I think patients will totally resonate with it because every single patient that I see gets fiducial markers. They have 0 problems with it. They want to have that ability for the machine to line up better. We put 3 or 4 little markers in. What's the difference between 3 and 4 little markers are actually putting in an agent that might have therapeutic benefit for you? The markers, right, they by themselves have no benefit. They help the machine in radiation therapy. So for me, I think the conversations that radiation oncologists have every single day will be this is just 1 other little part to a process that is radiation therapy. For the analysts, I want to make sure you understand that we don't see a lot of the active surveillance patients that people talk about in the prostate world. This is all a group of patients with real prostate cancers who get real therapy with radiation therapy. And with that, some of them need the appropriate therapies to intensify this. And that, like we spoke about before, there may be an opportunity to de-intensify and get away from the elephant in the room, the ADT. But I think what I would describe for workflow and process for radiation that should integrate extremely well by people who already know how to do most of accessing the prostate, either putting markers in our fiducial markers or spacing, this should just be seamless. The group that has brought this to market should not have a problem in the community setting. I'll let Dan speak to the academic setting about how that might be.

Dr. George, anything you want to add?

No. I think you're going to see rapid uptake in the academic multi [indiscernible] clinics as well. And it's even easier for the radoncs and urologists to collaborate there and their tumor boards and whatnot. So I think as Dr. Finkelstein said, I don't see any impediments in either setting.

Thank you very much. For those online, I don't want to exclude Dr. Shore as a surgeon. He had to leave. So that's the reason. Sudan, any other questions?

Yes. Again, I appreciate the details on the answer to the previous one. My next question for the Candel team specifically. Does the team intend to pursue a label solely within the intermediate risk category? And could you also provide color if the intermediate category carries different sales approach versus the high-risk category? And glad to hear the physicians' take on these as well if they have any commentary.

Who wants to take that on?

I'm happy to take it. I'm happy to take it, Paul-Peter. So yes, we intend to file for an indication that would basically encompass the patient population that we treated in the Phase III trial. So that would be intermediate, favorable patients, intermediate unfavorable patients and high-risk patients, those that have 1 high-risk [ beta ].

Thank you very much. Back to the operator.

Our next question comes from the line of [ Stephen Willey ] of Stifel.

Maybe just a follow-up to the last question. And again, I appreciate the additional granularity you guys are providing around the intermediate risk outcomes just relative to the intent-to-treat population. But curious if this changes at all, your perspective on the opportunity in high-risk patients? And also just wondering if you've done any additional analyses of the intermediate risk outcomes as a function of favorable or unfavorable risk stratification? And then I just have a follow-up.

Yes. Garrett, do you want to speak to that?

Yes. We certainly see comparable outcomes in terms of hazard ratios. We previously presented that data at ASCO last year in addition to the [ ASTRO ] presentation that was given at last year's conference as well. We'll continue to provide those updates as we continue to collect data. These patients all continue to be followed up. So we will continue to update and plan to do further analyses in the run-up to the BLA. But the bottom line is patients with both favorable disease, unfavorable disease and high-risk disease are accomplishing similar benefits in terms of decreased hazard ratios. And we're also very happy to be very close to publication of our pivotal trial manuscript, which will be coming out in [ Prestex ] month.

In the [ Lancet ] oncology. Yes. Thank you very much, Garrett. Steve, any other questions?

Yes. Just a quick follow-up, and this is just really just kind of a basic trial protocol question. But Were patients blinded to the 2-year biopsy results?

Yes.

The patients were blinded to the 2-year biopsy results because we are keeping these patients in follow-up, and it was important for us not to influence the decision of the physician on the base of the biopsies. Yes, they're blinded.

Yes. Via central reading, right? So all these biopsies in the central read were done, then we had completed the whole clinical trial. I hope that answered your question, Steve?

They did. I appreciate it.

Okay. Back to the operator.

Our next question comes from the line of Alec Stranahan of Bank of America.

I appreciate you hosting this event around AUA. I've got a follow-up just on the actually, median duration of follow-up. I think it's 58 months, if I'm reading the slides right. I appreciate this is already a long time in the context of the clinical trial. But I guess, given that the majority of the curve separation seems to occur sort of around the 78 month time point, how might you expect the data presented today to change over time? And assuming this doesn't -- this wouldn't be part of the consideration around approval, just given the [ file ] that you have.

Dr. George, do you want to start?

Yes, Dan George. It's a good question. It's hard to predict these things. But in general, once the curve start to separate, it's not uncommon to see them separate further. We do expect the outcomes here are delayed. So we're not surprised by the limited number of outcomes. But the hope would be that we would continue to see that separation, and if anything, get wider over time. We do expect to see more events in both arms. But we're already seeing this very early separation, which is -- it's remarkable, the degree in which we're seeing in 1 arm and not the other, I think that bodes well for the future.

Dr. Finkelstein?

I think Dan summed it up well.

Alec, any other questions?

Yes. I guess just 1 to follow up, Paul-Peter, maybe around the manufacturing piece. I guess, could you maybe just remind us sort of the advancements that have been made over the past 6 to 12 months as you move towards the commercial scale process and what's sort of left before you get the rolling BLA over the finish line later this year?

Yes. Thank you for asking the question. If you had not done it, I would have asked it actually to our Chief Technology Officer. So Seshu, maybe you can give a quick update in just a few minutes?

Sure. Thank you, Paul-Peter, and thanks for the question. So I'm Seshu Tyagarajan, CTDO for Candel. We have continued to make progress on the time lines that we had shared with the group earlier. So basically, we are already in the large scale in the commercial scale process for the last 2 years, so to speak. Currently, we are doing process validation with -- and everything being on track for the BLA filing in December. Does that answer your question?

Did that answer your question, Alec?

Yes, that's helpful.

I want to give you the opportunity to ask 1 more question if you have one.

That's good on my end for now.

Okay. Great. Thank you so much. This concludes our question-and-answer session. So I want to make a few closing comments. Thank you to our panelists for an outstanding discussion. Thanks to the analysts for their questions. Before we close, I also want to leave you with these thoughts. Our vision is to offer patients better disease control. Freedom from disease recurrence, freedom from local and metastatic disease progression and freedom from the need to use salvage anticancer therapies, as you heard, associated with toxicity and loss of quality of life. The data presented today suggested that aglatimagene may help patients with intermediate or high-risk localized prostate cancer who elect to undergo radical treatment to achieve the goal of elimination of the tumor and the prevention of cancer recurrence. And consistent with this objective, extended follow-up showed favorable trends in time to biochemical failure, time to metastasis and time to salvage anticancer therapy. So thank you, operator. Also, many thanks to everyone who's listening for joining our call today, and I wish you all a great day. Over to the operator.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.