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 guest thought leader physicians. At this time, all participants are in a listen-only mode. Following the company's formal remarks, we will open the call for questions. 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 announcements 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, 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 providing 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 the 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. W. Garrett Nichols, our Chief Medical Officer, Dr. Francesca Barone, our Chief Scientific Officer, Susan Stewart, our Chief Regulatory Officer, and Seshu Thyagarajan, 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, Steven Finkelstein, National Director of Radiation Oncology, USUP, Director of Radiation Oncology Research at AMP, Daniel George, Professor of Medicine, Surgery, and Urology at Duke University School of Medicine, Director of Genitourinary Oncology, Duke Cancer Institute, and Neal Shore, Medical Director at Carolina Urologic 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 CEO, Paul Peter Tak. Paul Peter Tak.
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. 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 men with intermediate or high-risk localized prostate cancer who elect to undergo radical 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 two years after radical therapy.
In addition, after tumor recurrence, salvage anti-cancer therapies, including long-term ADT, are associated with side effects and impaired quality of life. There's still a significant unmet need, as around 30% of the patients will develop recurrent disease despite radical prostatectomy or radiotherapy. Therefore, we aim to assess whether our investigational immunotherapy, aglatimagene plus valacyclovir, which is a pro-drug, then added to standard of care radiotherapy, could reduce the risk of prostate cancer recurrence compared to 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 prodrug combined with standard of care radiation 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 a 2-year 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 anti-cancer therapy in the aglatimagene arm versus placebo in patients treated with standard of care radiotherapy with curative intent. Dr. Garrett Nichols will present this data in a minute. It's important to note that the phase III study was conducted under special protocol assessment agreed with the U.S. Food and Drug Administration, the FDA. We have also received Fast Track designation and subsequently Regenerative Medicine Advanced 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 the 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. 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 transperineally using some small 20-22 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 at the same visit as fiducial markers and potentially spacer placement. 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 to 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 it's 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 or an African American patients. Approximately 85% had intermediate risk prostate cancer and had baseline Gleason score of 7. Nearly half planned to use short-term ADT.
The updated trial results as of March 15th, 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 anti-cancer 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 anti-cancer therapy, the Kaplan-Meier on the left, by 49% and the time to biochemical failure, the Kaplan-Meier on the right, by 52%. 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 a third of the patients. These were all low-grade and self-limited. 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 two-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 anti-cancer therapy in the aglatimagene arm versus the placebo arm. These clinical benefits were not observed to be associated with additional significant toxicities.
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 advisors who participated in our clinical trials, 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. 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. Sorry, to our loyal shareholders, we thank you for your trust and support and look forward to our continued partnership while we advance our progress.
With that, I would like to introduce you to Doctors Steven Finkelstein, Daniel George, and Neal Shore, who will briefly share their background and discuss what these findings mean for patients. Next, we will open it up for questions. 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 am the National Director of Radiation Oncology for U.S. Urology Partners and the Director of Radiation Oncology Research for Associated Medical Professionals. It has been an interesting journey for me. I cut my teeth as an 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. Putting a personal reference, my father, Howard Finkelstein, was diagnosed with high-risk prostate cancer.
After reviewing all his options, which was 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 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 challenge, 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 one 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 oncologist and an immunotherapist. This is what we have been waiting for for 20 years.
I think that the data presented today at the AUA will be something that we talk about in the same way as KEYTRUDA was when I was on the podium as discussant three days after its approval. I had told the field of radiation oncology at ASTRO that KEYTRUDA would be transformative in the field, 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, I will defer to my colleague.
Yeah. 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. Over to you, Dr. George. Please share your background and your thoughts about the data that we've shared today.
Thank you. Yes. Can you all hear me okay?
Yes.
Yes. Great. Hi, this is Daniel George from Duke University. I apologize for calling in remotely here. 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 University and professor of medicine, et cetera. From my perspective, for our patients, and I'm in clinic today seeing them, the number 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.
I understand this data is with and without hormonal therapy, but the real benefit here will be for patients that have intermediate-risk disease that we're concerned, you know, will have a risk of residual local disease. 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, getting better local control now is really critical. 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, you know, they want to have their anatomy intact. 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. The injections, although, you know, they sound, you know, kind of complicated and everything, that is a routine practice in urology and radiation oncology. It's something these patients are routinely undergoing with fiducial marker placements and other things. This is not a burden, an outsized burden on the treatment plan.
This is something our patients are gonna very much appreciate and gravitate to, and it's gonna get more patients off the fence between surgery or radiation.
Well, thank you so much, Dr. George. We may come back to that last point, later on. Let's move on to Dr. Shore.
Yeah.
Maybe you can introduce yourself, your background and share your views on what's presented today at the AUA.
Yeah. Hi, 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, patient-reported outcomes, and follow those patients as well, and I'm excited about that. I'll echo, you know, the comments of Doctors Finkelstein and George in that, and as somebody who actually administered product, it's very simple. A 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 four-quadrant approach is very, very simple. It's not particularly complicated.
Taking the oral valacyclovir is extremely well-tolerated by and large. 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 is to radiosensitizers. As Dr. Steven Finkelstein knows and the whole field knows, for many years, they've really been very wedded to testosterone suppression. If there's an ability to avoid that, certainly you 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 really long prospective trial, that you have, pathologic CRs that beats the placebo arm, that you have diminishment in BCR as well as metastases, that just sets off a whole cascade of other, therapeutics, either oral or parenteral, which, you know, do cause side effects, do impact patient quality of life. I'm just sort of recapitulating the data that you heard, the comments from Doctors Finkelstein and George, and, I do think that this is certainly gonna 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. 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. 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. What does that look like in clinical practice?
I think how it integrates into radiation oncology is, will be pretty seamless. We are very used to using fiducial markers, as my colleague Dr. Shore said, and 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 a one 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 like 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 two-thirds of the time. The same is true for surgery in this situation. 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.
For 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." I think this is something, again, very exciting, which I believe five 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. Daniel George, and maybe you can share your thoughts about shared decision-making, the choice to undergo radical prostatectomy versus radiation therapy. How do you look at this also from a more medical oncology perspective?
Yeah, thanks. You know, I think the real issue when we talk with patients with localized disease, whether they're intermediate, you know, unfavorable intermediate or favorable high risk, these are patients that have a life expectancy from prostate cancer that, you know, hasn't reached the median. Well, what do I mean by that? Half those patients are not gonna die of prostate cancer. More than half are not gonna die of prostate cancer. Most of these patients are gonna die from other causes. There's a small percentage, you know, and it's probably somewhere in the sort of 20 to 30% range, that at 15 years, these patients will die of prostate cancer. 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?
The perspective here is focused on a quality-of-life goal. That's really important. That's why we do the shared decision-making because we really need to understand from the patients just how aggressive they wanna be, how definitive they need to be, how comfortable they are with the different approaches and side effect profiles. Because a lot of men are diagnosed in sixties and seventies and even eighties, you know, we are looking for ways of non-surgical approaches. The use of radiation has increased in this country over the last few decades. I think as I've mentioned earlier, the biggest thing holding it back is the hormonal therapy.
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 four months, we can see men lose muscle mass that's equivalent of ten 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. People talk. You know, someone gets prostate cancer, they start talking to their friends who have prostate cancer and people start telling the woes of hormonal therapy. It's why patients come to us concerned about this. Frankly, as a medical doctor, I'm concerned about it.
To me, this is really I mean, I think, you know, as I mentioned, I think a great breakthrough for the patients that, you know, we don't necessarily need to use hormonal therapy and we can improve the outcomes, as Dr. Finkelstein mentioned. It's also gonna 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, you know, now a very validated approach and something that patients are very comfortable understanding. You know, 10, 15 years ago, it might've 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. 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.
if we can take two years of hormonal therapy down to six months by using something like this, you know, those are the kind of things that are gonna really change practice. I think this would, you know, 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. Thank you very much. Dr. Shore, maybe you can elaborate a little bit on the procedure. Right. What does that look like? How complex is it actually to inject this into the prostate? How does it compare to the standard of care diagnostic biopsy? What is the urology workflow in these spaces? 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 longstanding 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 transrectal 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, peri-prostatic local injection of an anesthetic. 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 a elaborate outpatient surgery center facility. If you have one and you wanted to do it there, that's fine too. It doesn't obviate 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. I think long the short answer is that the technical expertise to do this, there really is no additional technical expertise. It's rather quite simple. 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. Thank you very much. I have many more questions that I could ask you, but I want to make sure that we give the analyst first the chance actually to ask their questions. Operator, over to you.
Our first question comes from the line of Yigal Nochomovitz of Citigroup. Yigal Nochomovitz, your line is open.
Hi. Great. Thank you very much for doing the seminar and for taking my questions. 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.
Now, thanks for the question, Yigal. Maybe Dr. George, maybe you want to start.
Yeah, happy to. Yeah, great question. You know, it's not, you know, that's not this study, but it's a very relevant question when we're in front of patients talking about these results. You know, when you look at the relapse-free survival rate, you know, it's a little bit complicated because it includes this biopsy, which we typically don't do in practice. 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. I think obviously we wanna see longer data, but, you know, 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. You know, the real goal is to prevent that metastatic disease. Now, with PET scan, we're picking up, you know, these microscopic sites or previously microscopic sites of disease earlier. There's lots of ways to intervene. 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, you know, every trial, you know, 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. That's why we do randomized trials.
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?
Yeah, go ahead.
Yeah, no. Could I ask a follow-up or if the others wanted to comment as well?
Yeah. Let's hear the additional comment.
I was gonna add, as a radiation oncologist, for these problems in prostate cancer, patients see both the radiation oncologist and the surgeon and are told that both of these approaches, as they have existed, are equal in outcomes. There has never been prospective, randomized, reproducible data that has shown one is better than the other. Now we have data from this trial, a phase III trial, that shows adding an agent, a plus one agent, to what we do in radiation therapy improves upon what we do in radiation. That's very provocative. 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 very much. To make sure that we hear the whole perspective from everybody. Dr. Neal Shore, do you want to add anything?
Yeah, I'll be very brief. You really can't make comparisons. That was not the study design here. Let's be very clear about that. You know, results that are obtained from different radiation oncology centers as well as different prostatectomy surgical extirpation centers, they vary based upon site and the specific physician. There's a range, and that's sort of the beauty that patients have 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, you know, 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, that we've actually gotten more involved with combination of systemic therapies, androgen receptor pathway inhibitors or biosynthesis inhibitors as well as testosterone suppression. 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. That's data that remains to be seen.
Thank you very much. Back to you, Yigal. You have an additional question or follow-up question?
Oh, well, my other one was more of a, I guess, a forward-looking question in terms of, you know, you mentioned some of the panelists mentioned the shift towards radiation away from surgical options in the United States. 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? If you could comment, you know, currently in your respective institutions, what is the current split in the localized prostate cancer between the two options today?
Who wants to start?
I can start. This is Dr. Daniel George. I mean, I think that as Dr. Neil Shore mentioned, there's gonna be wide variation in practice patterns out there and patient populations. I would say if we're gonna generalize, our younger patients are still gonna be attracted to doing surgery. 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 or lung. Surgery is the mainstay of how we control that local site of disease, and it gets us, you know, more information about the tissue, but most importantly, it gets that primary out. It essentially removes the root of the disease.
That, you know, that's gonna always be the case. The truth of the matter is because this is such an indolent disease that 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, you know, alternatives to maintaining your anatomy become even more important than all the information and peace of mind of having it out. 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 gonna be the case. It's fine. You know, I think there's also going to be, you know, some men who really wanna preserve their anatomy.
The more data we have to show that we can do that in a way that, you know, doesn't expose them to these 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 gonna tip it. You're not gonna see a seismic shift, but I think it'll tip the radiation trends even more in that favor. You know, we're getting better and better at our technology with radiation and things like that. It's not that surgery's gotten worse. It's just that we're getting more and more effective in our forms of radiation delivery and whatnot. I think that's why you see some of those trends over time.
there's always gonna be both in the field.
Yeah. Thank you. 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's trying to push for more surgery. 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 sequelae on the bladder and on the rectum, we've characterized that very well. That has to be 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. You know, we're gonna 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'll be in Lugano. 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 gonna be particularly provocative is for all the reasons that you just heard. Whether it, you know, Is it, you know, 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 oncologist. 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 of the next analyst.
Our next question comes from the line of Imogen Mansfield of Cantor Fitzgerald. Imogen, your line is open.
Great. Thanks very much. Congratulations on the update and thanks for bringing such a great selection of KOLs onto 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 DFS for them. I'm gonna have one more question.
Thank you very much for the question. Who wants to start? Dr. Finkelstein?
Sure. 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? You have data in the intermediate risk and the high-risk space that meets 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?
I think that this has been an approach that has gone for the data when it goes back now almost a decade, shows that, you know, this kind of approach goes from pre-clinical 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?
Yeah.
Sure.
I guess just specifically around the sort of degree of benefit, is that something that patients would find appealing? Are they kind of seeking as sort of intensive therapy as possible? 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?
Yeah, this is Dan George. I can follow up on that too.
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 and 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. You know, 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. What I would say is it's a much greater, you know, overall relative benefit, you know, even to what maybe what we see with hormonal therapy. Yeah, I think patients can be very excited about that.
Thank you very much. Imogen Mansfield, any other questions?
Yeah. 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.
Yeah. I don't have the total number of events in each arm. I think it's 127 total events for the prostate cancer, you know, specific outcomes. We can get back to you as far as that number is concerned.
Thank you very much. I propose that we go to the next analyst. Operator.
Yes, sir. Our next question comes from the line of Oliver McCammon of LifeSci Capital. Your line is open, Oliver.
Congratulations on today's update, and thanks for taking my questions. For the external experts on the call, we heard some discussion on potentially sparing patients hormone therapy. Assuming 2409 is approved, do you think ADT use could shift among the intermediate and high-risk patients electing to receive radiotherapy? How would this potentially, you know, fit into NCCN guidelines? Can you remind us what's attractive about avoiding ADT? Sorry for all the questions. Thanks.
Thank you very much, Oliver. Dr. George?
Hi, Dr. Daniel George. I'll answer the second one first and maybe Dr. Steven Finkelstein can talk a little bit about the context in radiation therapy. From a patient standpoint, hormonal therapy is a life-changing effect. Look, I mean, in a word, this is sort of like male menopause. It is something that hits quickly. We drop testosterone within days. It is something that affects people from head to toe in terms of everything from, you know, mood swings and irritability to hot flashes, to, you know, loss of libido and motivations to myalgias and muscle aches and joint aches.
More importantly, we're having metabolic changes that are happening to these patients over a, you know, 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, you know, lipidemia, increased glucose intolerance and diabetes. We see hypertension. We see increased risk of stroke and heart attack.
I mean, we're, you know, we're accelerating for what is already happening in many of our patients, their comorbidities. This is the really critical thing here, is that, you know, we end up, you know, not just dealing with prostate cancer, but dealing with all these other medical issues that now have intensified because of the hormonal therapy. When we stop it doesn't reverse. We've shrunk the testes down. We stop the medicines, the testes are still shrunk. It takes months for those things to recover, and usually only about halfway of the testosterone. 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.
that's the struggle that we have, and it's why this is, you know, so important. You know, I can't really overestimate just how important, you know, the avoidance of hormonal therapy is. We give that medicine very reluctantly in this setting. It's because the only thing we've had to enhance the radiation therapy effects. Now we have something else.
Dr. Finkelstein?
Yeah, I think, as Steven 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 wanna 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. 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.
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 we'll see what happens at later with respect to maybe without ADT as further data continues to develop. I think that for the first time in 20 years, the ability to offer patients not what patients come to radiation oncologists and are not worried about the radiation. Or we do radiation therapy now with technology that didn't exist. We, I mean, 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. Like I said, an 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.
Thank you very much. Oliver, do you have any other questions?
Yeah, one for the Candel team. You know, you have a sizable presence at AUA this year. Can you walk us through how you're engaging with the potential treating 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. Thanks again.
Sure. Who will take, Yeah, go ahead.
Yeah, I'd be happy to address that. This is W. Garrett Nichols.
Yeah.
I'm 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. You know, 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. We have a couple 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 five minutes ago that Imogen asked about the number of events. Do you have them already?
Yes, we did pull those 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 two-to-one randomization, so that's the reason for the, you know, for the delta.
Thank you very much, Garrett. Imogen, I wanted to show how this team operates at fast pace. Operator, back to you for the next question.
Thank you. Our next question comes from the line.
Hi, sorry about that. Congratulations on the presentation, and thank you for taking the time to, you know, host this call. Two from me. Maybe 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 just intermediate patients, or potentially just select higher risk patients at first? Can you maybe translate that to how many patients you currently see? 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, you know, injection followed by radiation oncology? Where do you see the biggest delta in terms of streamlining this therapy between the academic setting versus the community setting? Thank you very much.
Thank you. Maybe, Dr. Shore, you want to start?
Well, I think that this will be, if approved, and certainly everyone's 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 and do the injection in terms of that technology. 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 at Duke and other places, and they have radiation departments.
for all the reasons that we talked about, avoidance of testosterone suppression with all the attendant sequelae, that really most patients, if given their druthers, would opt out of that. I think it'll be well-received by the academic and the community radiation oncologists as well as the community and academic urologists.
Dr. Finkelstein?
Steven 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. We're U.S. Urology Partners. My personal practice is in Syracuse. I could 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. Everyone who knows how and facilitates this regularly to help radiation oncologists who don't do these kind of procedures is gonna rock and roll with this, in my mind.
I agree with Dr. Shore completely. I also think that is, it you know, it's interesting, you know, 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 gonna create a new set of radiation oncologists who get more interested in it. A bunch of my friends within the field have been talking about this and how, you know, people who do brachytherapy or other things, get interested in things they can add to their practices. I think there'll be some markets that a urologist very much wants to be and will totally go head over heels with. I think there are other markets with radiation oncologists for it.
For our friends at Candel, I don't think it matters that much. I think no matter where you are, someone is gonna be excited about doing this within that market, and those things will take care of itself. I do wanna add one last thing that, you know, I don't wanna speak for Neil, 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 wanna meet with, and the team that they've put together is really incredible.
that team, to the previous analysts who asked about what they plan to do, everything they've done has been nothing but top shelf and engaging, I think the key players within this. Like I said, we don't take our time lightly. I don't wanna speak for Neil, but we don't take our time lightly to be in front of you today in a busy AUA meeting to do this. It has to be something of importance. That's why we're here today.
Well, thank you very much. I want to say that I really appreciate that. Andres, time for one quick additional question if you have one.
It's exciting to hear about, you know, how homogenous kind of the uptake could be across the community in the academic setting. Just one point of clarification there. Would you expect that the identification for 25 for the best patients for 2409 would happen. You know, you spent some commentary, you know, about when it would be identified after biopsy, after MRI or after genomic testing. Do you find a bottleneck between academic and community settings where, you know, 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?
Yeah. I can take it.
Okay. Go ahead.
Yeah. Let me 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 gonna talk about what the standard of care is. A phase III trial came today that says there's an additional thing for the standard of care. If that means adding one more step, which is adding the ability to give this novel agent with it, we will most likely set that up with the urologist when they're doing spacing and fiducials. We'll just incorporate this.
If this hits an FDA approval, we'll be ready to excel in it. Hope that's helpful to you.
Thank you very much. Maybe I should add that in the clinical trial, in the phase III trial, actually, we had more patients who were involved in the community centers than in the academic centers. I think it supports the view that this can be relatively easily implemented. 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.
Thank you. Our next question comes from the line of Kemp Dolliver of Brookline Capital Markets. Kemp, your line is open.
Thank you. At the risk of your 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. I mean, I think, you know, obviously, they're gonna have to do some marketing and everything to get the word out there. This is gonna, I mean, this is high profile just at AUA, huge exposure there. I think you're gonna see a lot of the larger urology groups rapidly pick this up in practice, along with the radiation oncology groups. Let me clarify one other point that was asked a couple questions ago about the volume. About this particular indication. 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, you know, that's a sizable population.
even if not all those patients are getting radiation therapy, these are not patients that are doing active surveillance. It's either surgery or radiation. I think you're gonna you know, 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 gonna be seeing those patients. I, you know, I think this allows them to, you know, to really integrate into that field and that practice very rapidly.
Thank you very much. Kemp, any other questions?
No, that's it. Thank you so much.
Thank you very much. Back to the operator.
Thank you. Our next question comes from the line of Sudan Loganathan of Stephens. Sudan, your line is open.
Hi, everyone. Thank you for this very insightful format. Great to hear from all the expert physicians as well on this topic. My first question for the experts is, considering the asset's potential mode of administration, could you provide some color on how this potential could be viewed as invasive, differs from the prostatectomy procedure? Like, would this level be qualitatively identified between the two procedures? Thanks.
Dr. Finkelstein?
Yeah. I'm gonna put it in context as one who did surgery then did radiation oncology. 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. I will tell you that as radiation oncologists, we quote that the rate of side effects of radiation therapy, any of our stuff, is less than the risk of going to sleep for the anesthesia.
As a person who converted as a award-winning surgeon to become a radiation oncologist, our perspective is that our stuff is really not that exciting. I don't 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. Now all you're really adding to this is an injection in this way that's really not exciting. The patients, the biopsy is not fun because you're actually pulling stuff out of the, 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 zero 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 three and four little markers or actually putting in an agent that might have therapeutic benefit for you? The markers, right? They're, they by themselves have no benefit. They help the machine in radiation therapy. You know, for me, I think the conversations that radiation oncologists have every single day will be, this is just one other little part to a process that is radiation therapy. I. For the analysts, I wanna 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 cancer who get real therapy with radiation therapy. With that. Some of them need the appropriate therapies to intensify this.
like we spoke about before, there may be an opportunity to de-intensify and get away from the elephant in the room, the ADT. I think what I would describe for a workflow and process for radiation, this should integrate extremely well by people who already know how to do most of accessing the prostate, either putting markers in or produce a mark or spacing. This should just be seamless. The group that has brought this to market should not have a problem in the community setting. Well, 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 gonna see rapid uptake in the academic multidisciplinary clinics as well, and you know, that it's even easier for the rad oncs and urologists to collaborate there and their tumor boards and whatnot. I think, you know, I think as Dr. Finkelstein said, there. 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, appreciate the details on the answer on the previous one. My next question for the Candel team specifically. You know, does the team intend to pursue a label solely within the intermediate risk category? Could you also provide color if the intermediate category carries different sales approach versus the high-risk category? I'm glad to hear the physician's take on these as well, if they have any commentary. Thank you.
Right. Who wants to take that one?
I'm happy to take it.
Yeah.
I'm happy to take it, Paul.
Please go ahead.
yes, we intend to file for an indication that would basically encompass the patient population that we treated in the phase III trial. That would be intermediate favorable patients, intermediate unfavorable patients and high-risk patients, those that have one high-risk feature.
Thank you very much. Back to the operator.
Thank you. Our next question comes from the line of Stephen Willey of Stifel. Your line is open, Stephen.
Yeah, good afternoon. Thanks for taking the questions and for hosting this. Maybe just a follow-up to the last question. Again, I appreciate the additional granularity you guys are providing around the intermediate risk outcomes just relative to the intent to treat population. Curious if this changes at all your perspective on the opportunity in high-risk patients. Also just wondering if you've done any additional analyses of the intermediate risk outcomes as a function of favorable or unfavorable risk stratification. Just have a follow-up.
Yeah. Garrett, do you want to speak to that?
Yeah.
Go ahead, please.
You know, 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 do continue to be followed up. We will continue to update and plan to do further analyses in the run-up to the BLA. The bottom line is that patients with both favorable disease, unfavorable disease and high-risk disease are accomplishing similar benefits in terms of decreased hazard ratios.
We're also very happy to be, you know, very close to publication of our pivotal trial manuscript, which will be coming out in press next month.
In The Lancet Oncology. Yeah. Thank you very much, Garrett. Stephen, any other questions?
Yeah, just a quick follow-up, and this is just really just kind of a basic trial protocol question, but were patients blinded to the two-year biopsy results?
Yes.
Yes.
Yeah.
The patient were blinded to the two-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 biopsy. Yes, they're blinded.
Yeah.
Got it. Fair enough.
We had the central reading, right. All these biopsies in the central read were done when we had completed the whole clinical trial.
Very good.
I hope that answered your question, Stephen.
It did. I appreciate it.
Okay, back to the operator.
Thank you. Our next question comes from the line of Alec Stranahan of Bank of America. Please go ahead, Alex.
Hey, guys. Thanks for taking my questions and 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. 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, is how might you expect the data presented today to change over time? Assuming this doesn't, this wouldn't be part of the consideration around approval, just given the spot that you have.
Dr. George, do you want to start?
Yeah. Dan George. you know, it's a good question. It's hard to predict these things, but, in general, once the curves start to separate, it's not uncommon to see them separate further.
We do expect, you know, the outcomes here are delayed, so we're not surprised by the limited number of outcomes. You know, the hope would be that we would continue to see that separation and if anything, you know, get wider over time. We do expect to see, you know, more events in both arms. We're already seeing this very early separation, which, you know, is, you know, it's remarkable, you know, the degree in which we're seeing in one arm and not the other. I think that bodes well for the future.
Dr. Finkelstein?
I think Daniel sums it up well.
Alec, any other questions?
Yeah, I guess just wanna 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? Thank you.
Yeah, thank you. Thank you for asking the question. If you had not done it, I would have asked it actually to our chief technology officer. Seshu, maybe you can give a quick update in just a few minutes.
Sure. Thank you, Paul Peter, and thanks for the question. I'm Seshu Thyagarajan, CTDO for Candel Therapeutics. We have continued to make progress on the timelines that we had shared with the group earlier. Basically, we are already in the large scale, in the commercial scale process for the last two 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?
Does that answer your question, Alec?
Yes. That's helpful. Thank you, guys.
Okay. Thank you.
I want to give you the opportunity to ask one more question if you have one.
That's good on my end for now. Thank you.
Okay, great. Well, thank you so much. This concludes our question and answer session. I want to make a few closing comments. Thanks 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 anti-cancer therapies, as you heard, associated with toxicity and loss of quality of life. The data presented today suggested that our aglatimagene may help patients with intermediate or high risk localized prostate cancer who elect to undergo radical treatment to achieve their goal of elimination of the tumor and the prevention of cancer recurrence.
Consistent with this objective, extended follow-up showed favorable trends in time to biochemical failure, time to metastasis, and time to salvage anti-cancer therapy. 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.