Candel Therapeutics, Inc. (CADL)
NASDAQ: CADL · Real-Time Price · USD
7.63
-0.04 (-0.52%)
At close: May 6, 2026, 4:00 PM EDT
7.65
+0.02 (0.26%)
After-hours: May 6, 2026, 7:53 PM EDT
← View all transcripts

Citi's Biopharma Back to School Conference

Sep 3, 2025

Jelena Hromavec
Biotech analyst, Citi Group

Good morning.

Paul Peter Tak
CEO, Candel Therapeutics

Okay.

Jelena Hromavec
Biotech analyst, Citi Group

Okay. All right, we can go. All right, is it working? I see a red color here. It's on? Okay.

Paul Peter Tak
CEO, Candel Therapeutics

It's on here as well.

Jelena Hromavec
Biotech analyst, Citi Group

Yeah, good. Great.

Paul Peter Tak
CEO, Candel Therapeutics

It's good.

Jelena Hromavec
Biotech analyst, Citi Group

All right. Welcome everyone to day two of Citi's Back to School Summit. We're all in study mode, back to school. I'm Jelena Hromavec, a biotech analyst here at Citi. For those of you attending in person, it's meant to be interactive, so if you have questions, just chime in. Also, welcome to those listening on the webcast. It's my pleasure to have the Candel Management Team here. We have the CEO, Paul Peter Tak, welcome, and the CFO, Charles Schoch. Welcome. Thank you both so much for joining. Paul Peter, maybe you could just start with a bit of an overview of the platform and the company and the key programs, and we can spend time over the course of the next 40 minutes going into each one, but just set the stage.

Paul Peter Tak
CEO, Candel Therapeutics

Yeah, sounds good. Thanks for having us, and hi Jelena and everybody. Candel Therapeutics develops viral immunotherapies for very difficult to treat solid tumors. We have three platforms. The first is CAN-2409, which is an investigational medicine that's in late-stage development. We have delivered on positive data based on the pivotal phase 3 clinical trial in an area of huge unmet need, which is newly diagnosed localized prostate cancer, where we achieved the primary endpoint supported by secondary endpoint, and we are preparing BLA submission. Second, we had also positive phase 2a data in borderline resectable pancreatic cancer based on a small randomized clinical trial where we focus on overall survival. You see a beautiful separation of the overall survival curves. Also, positive phase 2a data in patients with non-small cell lung cancer, unresectable, stage 3 or stage 4. Actually, 90% had stage 4 disease.

Most of them had progressive disease despite optimal standard of care, including immune checkpoint inhibitor treatment. Most of these patients had also failed platinum-based chemotherapy and had many unfavorable baseline prognostic factors. Very encouraging overall survival data there as well. We call it a platform because this is a pan solid tumor therapy that we've shown consistently positive data, also in other indications that we currently do not pursue because we went through a rigorous prioritization. The second platform is called CAN-3110. Again, that's an investigational medicine. It has a different mechanism of action. It's also a viral immunotherapy, but it's a unique replication-competent herpes simplex virus that will replicate specifically in the tumor while sparing the healthy tissue. We test it in the most difficult to treat form of cancer, probably, which is recurrent glioblastoma, brain cancer. These patients have failed neurosurgical resection and chemotherapy and radiotherapy.

They run out of options. They have a life expectancy of typically less than six to nine months. We have very encouraging data that we published in Nature. We're building on this at this time. This is a big opportunity where others have failed. We also see it as an enabling indication for other tumors outside the brain. Think of, for example, triple negative breast cancer or melanoma and others. Therefore, we also call this a platform. Third, we have created a discovery platform that we call the enLIGHTEN Discovery Platform. enLIGHTEN refers to the name Candel, to light. We light up the tumors, basically, right? We illuminate the tumors from an immunological perspective. This has been very successful. We have three early, three clinical candidates in the discovery pipeline. Together, that's Candel Therapeutics at this moment.

Jelena Hromavec
Biotech analyst, Citi Group

Let's start with the latest stage then with the prostate cancer. You're going into a very interesting slice of the prostate cancer market, but you know it's a big slice and it could be a bigger slice depending on where you go. Explain what this is, this locally advanced market and how it's, what the options are for patients, you know, the radiotherapy and the prostatectomy and how you've done the study to support this admittedly novel but very interesting thesis, which is gaining adoption.

Paul Peter Tak
CEO, Candel Therapeutics

Yeah, we have focused on newly diagnosed localized prostate cancer unlike everybody else who are focused on more advanced stages of the disease. Why is nobody else focused on early localized prostate cancer? Because it takes a very long time to do the clinical trial. It took us 12 years, actually, because you need to show that patients who want to be cured are free of cancer, that they achieve disease-free survival, which is a higher hurdle than living longer with cancer. The good news is we've done it and we have achieved the primary endpoint supported by secondary endpoints. If patients are diagnosed with localized prostate cancer and they have intermediate to high-risk prostate cancer and they want to get rid of their tumor, they want to eradicate the tumor, there are two possibilities. They can choose either radical prostatectomy, which is major surgery, or they can choose radiotherapy.

It's about 50-50, right? This is based on shared decision-making between the physician and the patient. About half of the patients will choose radiotherapy as part of a radical treatment. The goal is to eradicate the tumor. That goal is achieved in many patients, but unfortunately, in about 30% of the patients, there will be a recurrence of the disease. This is true for radical prostatectomy as well as for radiotherapy. We focus on the patients who choose radiotherapy, and our goal is to increase the proportion of patients that will stay free of cancer. Why is that important?

Although there has been quite a lot of progress in the treatment of prostate cancer and patients can live longer, and in many cases, it's a slowly growing tumor, it still has a big impact on the quality of life of these patients because it's not great to know that the tumor has come back, right? It leads to fear of recurrence. It leads to cancer-related anxiety. It leads to signs and symptoms due to local progression of the disease and local regional progression and ultimately development of metastases. After 10- 15 years, to prostate cancer-related mortality. Also these patients, if they have recurrence, will need so-called salvage therapies. In the first place, salvage long-term ADT, androgen deprivation therapy, is basically chemical castration, which has a very negative impact on quality of life in about two-thirds of the patients. Many patients hate this treatment.

We try to avoid the recurrence of the disease, and that's what we've shown in the clinical trial.

Jelena Hromavec
Biotech analyst, Citi Group

Okay. Can you just maybe walk through, just so everyone's clear on the data and what you showed in terms of the benefit? You showed it on DFS for everything, and then you showed prostate specific as well. Can we go through that? I want to understand.

Paul Peter Tak
CEO, Candel Therapeutics

Yeah, absolutely. The clinical trial was conducted under a SPA, special protocol assessment, agreed with the FDA. Why? Because this is a completely novel approach. If you focus on patients with advanced disease, you will focus as a primary endpoint on endpoints like metastases-free survival and overall survival. If you try to have curative intent, as we have, then you need to focus on disease-free survival. We wanted to be absolutely clear that there was alignment with the FDA about the trial design and the primary endpoint. This has been reinforced over time, and also we got, based on the data, with the data in hand, the RMAT designation from the new FDA, as I call it, which is the Regenerative Medicine Advanced Therapy designation, which is like a breakthrough designation for gene therapy. What have we done? What is disease-free survival? It's an event-based endpoint. What is an event?

This could be a recurrence of the disease, as shown in two-year biopsies, as requested by the FDA, because that's the most sensitive way to detect tumor cells. You take a biopsy after two years in the patients, and if there are any tumor cells, it's an event. It's positive. If there are local signs and symptoms of prostate cancer and confirmed by histology, by taking biopsies and/or imaging, that's an event. If there would be development of metastases, which takes a longer time typically, that would be an event. If a patient would die because of prostate cancer, that would be an event, but you don't expect that because we had a follow-up period of a little bit more than 50 months, so let's say close to five years.

It's very well known that you would need to have a study with a median follow-up of at least 10 years to show the benefit in terms of prostate cancer-specific mortality. Therefore, the FDA requested that we would actually include death due to any cause. If a patient died because of a heart attack or a stroke or an accident, that would all count as an event. That means that we had to dilute the signal with events that are completely unrelated to prostate cancer. Despite that, we convincingly showed that we could see an improvement by 30% in terms of disease-free survival. From what I just said, it follows that the key secondary endpoint is prostate cancer-specific disease-free survival where you exclude death not related to prostate cancer.

If a patient had an accident, we had a patient who fell from a ladder, there was a patient who was murdered, clearly that has nothing to do with prostate cancer, then it looks even better. We see a 38% improvement in prostate cancer-specific disease-free survival, also supported by a statistically significant improvement in the proportion of patients that had low levels of PSA and also shown by a pathological complete response as shown in the two-year biopsies.

Jelena Hromavec
Biotech analyst, Citi Group

Very good summary. You mentioned that about 50% of the patients do the prostatectomy and then the others do the radiotherapy. I think you may have made the point in the past, but we'd love to hear it again. With your data, there's the potential that that could shift or you could see more of a shift to the radiotherapy given your data. Is that a fair statement? How does that market dynamic work?

Paul Peter Tak
CEO, Candel Therapeutics

Yeah, we've not done a head-to-head comparison to surgery and we're not going to do it either. We learned something really interesting based on the market research that we've done with the data in hand. If CAN-2409 is approved after BLA submission, as we hope, there will be three options for patients. First, radical prostatectomy. Second, radiotherapy as it is right now. The new and third option will be radiotherapy plus CAN-2409. As I mentioned, we know that there's a chance of recurrence for both radical prostatectomy and current radiotherapy of about 30%. We've shown that the third option should lead to better outcomes over time. You could imagine that more patients will choose the third option and that there will be a shift from radical prostatectomy towards more patients choosing radiotherapy combined with CAN-2409.

Even if that would not change at all, at this time, 65,000 patients per year are treated with radiotherapy as part of radical treatment, which is a huge number. This is a very, very big market. Even without any change, the expectation, as we heard both in the U.S., in market research, and in Europe, would be that more patients would choose this third option.

Jelena Hromavec
Biotech analyst, Citi Group

Okay, you mentioned the market and the BLA. Can you talk about just the timelines and the strategy for filing the applications? I understand there's some more work to do before you can file. What's the strategy here in the U.S.? Europe's also a very important market. What's the strategy over there?

Paul Peter Tak
CEO, Candel Therapeutics

Yeah, so what we've said in December last year, immediately after the data readout, is that we are aiming for BLA submission in Q4 2026, right? That is because of scaling up on a commercial scale manufacturing and putting the product on stability. Actually, it's a lot of work that needs to be done. It's now September, so next month we will be in Q4 2025, and we are halfway, and we are completely on track. It's a lot of work that's going on. I'll give you some examples of the work that we've done. This is new, that we have not disclosed this before. We've successfully completed three commercial runs. That's one. The second is we've done a lot of work, and we are doing a lot of work in terms of assay development, right?

Qualification and validation of the analytical assays that you need also to get through the BLA submission. Third, we are in close contact with the FDA, and of course, we have the benefit of not only having the SPA, but also the FastTrack designation, and now also the RMET, so we can organize RMET meetings, et cetera. We are also working very closely with the FDA on a comparability study, which is expected to start in Q4 of this year. This is going to start in the very near future because we have a new process and a new product, but it's similar, but not identical to the previous product. You want to show that there is comparability. These are some of the things that we are doing. We are also preparing the so-called PPQ run. Again, we are talking to the FDA. That's the product performance qualification, right?

This is a very big thing. We are preparing this, and we are in close contact with the FDA to make sure that we are absolutely aligned about what they want to see.

Jelena Hromavec
Biotech analyst, Citi Group

Okay, you mentioned the three commercial runs. That's with the old process?

Paul Peter Tak
CEO, Candel Therapeutics

Old new process.

Charles Schoch
CFO, Candel Therapeutics

We've made enormous progress actually since we started all of this. Three commercial runs, a lot of work going on in terms of analytical assay, qualification and validation, design of the biodistribution and shedding study that is expected to start shortly, and preparation of the PPQ in alignment with the FDA.

Jelena Hromavec
Biotech analyst, Citi Group

Are there differences in the two? You mentioned the comparability study. What was done in the phase 3 trials was presumably the older version, and now you're going to, you just finished the runs for the new version. What do you need to show with comparability? Obviously, you're not going to do another efficacy trial with, let's say, a 10-year. I mean, that's not happening. What exactly does the FDA need to see to?

Charles Schoch
CFO, Candel Therapeutics

That's a relatively straightforward study where you look at short-term effects. This is a relatively small study. We've not disclosed exactly what it's going to look like because we're still in discussion with the FDA about this, but there's not another clinical trial where you need to look at disease-free survival.

Jelena Hromavec
Biotech analyst, Citi Group

Okay.

Paul Peter Tak
CEO, Candel Therapeutics

It's a short-term study.

Jelena Hromavec
Biotech analyst, Citi Group

What are the benefits of this improved process? Are there specific benefits, or is this just a more modern manufacturing with a different?

Charles Schoch
CFO, Candel Therapeutics

Yeah, the previous product was produced at the site from Lonside. The site even doesn't exist anymore. We had to create a new process, but of course, there's been a lot of development in the last 10 years, right? The production of replication defective adenoviruses has really been scaled up. Just think about what has been done by companies like Janssen and AstraZeneca in terms of replication defective adenoviral vaccines. There's been a lot of progress, and the process will be more efficient is the expectation.

Jelena Hromavec
Biotech analyst, Citi Group

Is this the one at Merck-Millipore, is that right, or is that a different one?

Paul Peter Tak
CEO, Candel Therapeutics

Our partner is SAFC, which is Merck-Millipore, in Carlsbad, California.

Jelena Hromavec
Biotech analyst, Citi Group

Okay.

Charles Schoch
CFO, Candel Therapeutics

This is produced in the U.S.

Jelena Hromavec
Biotech analyst, Citi Group

Okay. As far as preparation for launch and so forth, what are you doing in terms of early commercial prep? I know you're not filing the BLA till the end of next year, but it's still a lot to do to prepare.

Charles Schoch
CFO, Candel Therapeutics

Yeah, I think the timelines work very well on multiple levels, and we've tried to be really strategic about all of this. First, we wanted to make sure that we would start scaling up manufacturing, which costs a lot of money actually. After data readouts, we've seen examples of companies that made different decisions like Oncorus, which unfortunately does not exist anymore, and we will never know whether their product worked. We've been very measured in our approach. Now we know that CAN-2409 works in prostate cancer and also very promising data in the other indications. A lot of work is going on in terms of CMC, all on track. I just summarized some of the work that we have delivered in the recent past.

We will also use that time to create more scientific data, which will be important from a regulatory perspective, from a strategic perspective when you engage with pharmaceutical companies, and also from a commercial perspective. We will use, for example, a biodistribution and shedding study, which will also be very important for the BLA submission, which is also a short-term study, to generate more data from an immunological perspective. It's really very important to have a very deep understanding of how the product works. If a patient does not respond, why is that right? Can we further optimize this in the future post-approval, et cetera? That's part of the work that's going on in the same biodistribution.

We will collect a lot of data where we will learn about the immunological mechanism, similar to what we've done in non-small cell lung cancer, where we have generated very deep data that we will disclose in the very near future. We've started multiple commercial work streams. All of this is going on in parallel, working with three parties. One is Idea Pharma. They're not just a consultancy firm. We've created a functional team consisting of leaders from Candel Therapeutics, including myself. I've been at the interface of R&D and commercial at a large pharma at GSK in the past, and my team is intimately involved, but there's also the people from Idea Pharma. Then there's Globe Life Sciences. They're an outstanding partner in terms of market research and payer research.

There's a third undisclosed partner doing a lot of work, pressure testing assumptions about pricing, for example, medical affairs activities. All that work is going on. I think a timeline of two years before approval is actually ideal because not everybody realizes that it's not sufficient to get ready for the regulators. You also need to be ready for the payers, and you also need to be ready for the healthcare professionals and for the patients. All these activities move on in parallel. Our strategy has been to create a pipeline in a product, and therefore, we are quite keen on advancing our programs in non-small cell lung cancer and also in pancreatic cancer so that you have in the future advanced programs at the moment that the clock starts ticking of your first approval.

Jelena Hromavec
Biotech analyst, Citi Group

Let's talk about some of the other indications before we run out of time. The lung cancer, you're about to embark or you're planning to embark on a phase 3. I think you've talked about that. Can you just discuss what that would look like and what the timelines would be and where you are from a funding perspective in terms of potentially kicking off that trial?

Paul Peter Tak
CEO, Candel Therapeutics

Yeah, we had a very constructive meeting recently, end-of-phase 2 meeting with the FDA, and we are aligned in our thinking about what that trial would look like. This will be a pivotal phase 3 clinical trial where we will select patients with metastatic disease. We're going to focus on stage 4 disease, progressive disease at baseline, despite pembrolizumab. We will choose one immune checkpoint inhibitor, the one that's most commonly used. We will focus on patients with progressive disease, and we will randomize them to either stop pembrolizumab and switch to second-line chemotherapy, which is docetaxel. This is standard of care at this time. Or they stay on pembrolizumab, although they had an inadequate response and actually have progressive disease, but we will give them two administrations of CAN-2409 because we've shown that we can convert non-responders to immune checkpoint inhibitors into responders.

The primary endpoint is going to be overall survival. The other point that we agreed with the FDA is that we will do a small phase two mechanistic study in parallel. It will be a short-term study, relatively small. We have not finalized the details, but I will share how we think about it. That's probably a study in about 55 patients. We will look at the contribution of effect. You may know that other companies had some difficult conversations with the FDA because they had not demonstrated convincingly, according to the FDA, the contribution of effect if you use your investigational medicine on top of, for example, an immune checkpoint inhibitor treatment. We have alignment with the FDA about what that study could look like. I'll share some ideas about what we're going to look at.

We've shown, based on nine patients in the phase 2A of a clinical trial that we have completed, where there were serial CT scans available over time, even before the start of our study, as part of normal standard of care, the tumor growth trajectory. We could show in these nine patients that these tumors were growing until we gave the first administration of CAN-2409, and then they stopped growing, and there was a gradual decrease associated with improved survival. We're going to look at tumor growth trajectories using serial CT scans in these patients. We're going to look at CT DNA as a measure of tumor burden. We're going to look at soluble granzymes as a sign of activation of CD8 positive tumor infiltrating lymphocytes, a key effector cell for the mechanism of action of CAN-2409, etc . This will be a deep mechanistic study.

We will randomize patients to either stay on pembrolizumab or they will get pembrolizumab plus two administrations of CAN-2409. This study will run in parallel with the phase three study and will inform at the time of Biologics License Application (BLA) submission in lung cancer the overall package where we have data supporting the contribution of effect. We will make sure that we are aligned with the FDA about what they are looking for.

Jelena Hromavec
Biotech analyst, Citi Group

If I get it right, that's all very interesting. The idea is that you don't want to run a phase three with pembrolizumab control because, you know, they won't respond. We've seen this many times where it's not a good second therapy to try to retreat. You want to do docetaxel, but you still want to have this contribution of components. There's this smaller study where, yes, you will treat a much smaller segment of people with pembrolizumab again, but not in a phase three. It's enough data to satisfy the FDA's curiosity on this question. Is that right?

Paul Peter Tak
CEO, Candel Therapeutics

Exactly right. We cannot do the phase three study like that because it would be unethical.

Jelena Hromavec
Biotech analyst, Citi Group

Yeah.

Paul Peter Tak
CEO, Candel Therapeutics

Here again, we won't actually wait for survival data. This will be mechanistic data. You want to see a complete separation for everything I just described, the tumor growth trajectory, the ctDNA levels, soluble granzyme levels. The patients who stayed initially on pembrolizumab will also get two administrations of CAN-2409, like an open label extension.

You have something to offer to all the patients.

Jelena Hromavec
Biotech analyst, Citi Group

Okay. That sounds like a very good meeting of the minds or compromise or whatever the word is. What about the, and then as far as the timeline, you've locked that down, but you're not quite ready to push go yet on that study. What needs to happen?

Paul Peter Tak
CEO, Candel Therapeutics

I've always said that we will not start this clinical trial in terms of patient enrollment before we have secured at least part of the financing through non-dilutive funding. That's still the strategy. We still plan to include the first patient, if everything goes well, in Q2 next year.

Jelena Hromavec
Biotech analyst, Citi Group

When you say non-dilutive, you've talked about different types of partnerships, regional partnerships, other types of partnerships. Is that what you mean when you say non-dilutive? Would that be something that, you know, intersects with the prostate market too, or would it be a lung cancer partnership or both, or how is it working?

Paul Peter Tak
CEO, Candel Therapeutics

It is very difficult to do a partnership for one indication. There are really no examples where this has worked. There are different forms of non-dilutive funding, and we are exploring multiple options, but it would probably not be appropriate to speak about this at this time.

Jelena Hromavec
Biotech analyst, Citi Group

Okay. No worries. You mentioned pancreatic. Can we talk about that one too? That's the other indication for CAN-2409. Where does that stand?

Paul Peter Tak
CEO, Candel Therapeutics

Yeah, absolutely. The priorities are, these are all high priority programs. Top priority is getting to BLA submission and approval for prostate. Second is lung cancer. After that is pancreatic cancer. We are preparing a scientific advisory board, which will take place this month, it's already September, where we work with the key experts. You may have noticed that we have created a phenomenal research advisory board.

Charles Schoch
CFO, Candel Therapeutics

We just announced yesterday that Carl June joined. Before we announced that, Liz Jaffe, who is one of the key experts in pancreatic cancer, has joined the research advisory board. We work closely with her and other key experts to design the clinical trial, which is going to be a slightly different approach than in lung cancer because there are more scientific questions that need to be answered. It's a little bit less straightforward.

Therefore, we are designing a phase 2B/phase three adaptive trial design, which could be a pivotal trial, potentially a registrational clinical trial. We will probably focus on the borderline resectable pancreatic cancer, as we did in the successful but small phase 2A randomized clinical trial that we have shared in the public domain. There may be small variations here. There has been some development in terms of chemoradiation as standard of care. We need to have absolute alignment about the best background standard of care. Of course, there are other interesting developments in the field of pancreatic cancer. Think of the advent of, for example, KRAS inhibitors. We are doing work with the key experts. We will have our internal governance process, which is called the Science and Investment Board. Then we'll talk to the FDA.

We'll have an end-of-phase two meeting with the FDA to get also alignment about the design of this potentially registrational trial.

Jelena Hromavec
Biotech analyst, Citi Group

In the phase two, you had a very, very strong OS. I know it wasn't randomized, right? It was randomized.

Paul Peter Tak
CEO, Candel Therapeutics

This was randomized, yes.

Jelena Hromavec
Biotech analyst, Citi Group

Oh, this was randomized. Okay. You had a, what was it, about a 20-month difference or something like that?

Paul Peter Tak
CEO, Candel Therapeutics

It was like the control group, optimal standard of care, 12.5 months in the active treatment group. Optimal standard of care, the same standard of care, plus two to three administrations of CAN-2409 was like 32 months. A very spectacular separation of the overall survival curve. If you are able to reproduce that, that would be spectacular.

Jelena Hromavec
Biotech analyst, Citi Group

That's a lot going on with those three solid tumors. Where would you go beyond that? I mean, in prostate cancer, you could go in different directions, right? You could go north or south, meaning like to the adjuvant, or you could go to the metastatic. What would come, would that be sort of the next thing to do, or would you look into other solid tumors outside of the three you've already studied?

Paul Peter Tak
CEO, Candel Therapeutics

In prostate cancer, we will seek approval in early localized, newly diagnosed prostate cancer. Post-approval, and this will probably be done in some form of strategic partnership, there's a real opportunity to expand also into oligometastatic and metastatic prostate cancer. Why? We actually have data from an old phase 2A clinical trial suggesting the efficacy of CAN-2409, also in patients with more advanced disease who had failed radiotherapy. We've seen that CAN-2409 works in metastatic progressive lung cancer. There's a strong rationale, but that would be post-approval. In lung cancer, we will do exactly the opposite. We are at the end of the spectrum, right? In patients who failed everything, progressive metastatic disease. If it works there, it's quite likely that it works even better in a neoadjuvant setting.

We have published a phase 1B trial showing the effects of CAN-2409 from a mechanistic perspective in newly diagnosed non-small cell lung cancer. Post-approval in lung cancer, we would also go to the earlier stages and expand to market. In pancreatic cancer, we will probably focus initially on borderline resectable pancreatic cancer. I think there's a real opportunity to also start to think about neoadjuvant therapy in patients who are ready to undergo major surgery, typically a Whipple procedure. I'm not sure about metastatic pancreatic cancer because you need some time to mount an effective anti-tumor immune response. This is an unknown. I think it would make more sense to go to earlier stages in pancreatic cancer rather than to the latest stages of the disease.

Jelena Hromavec
Biotech analyst, Citi Group

Okay. At the beginning, you mentioned the other program or the second of the three platforms. For high-grade glioma, this is the one you said that was replication competent. First of all, just explain to those that are less familiar why for this particular situation the replication competent is the one you want. What has the data shown in this setting? I think you also are planning to have an update later in the year.

Paul Peter Tak
CEO, Candel Therapeutics

Yeah. The activity of CAN-3110 is unique because it contains a gene that everybody else has deleted, which is called the ICP34.5 gene. It plays a critical role in the replication of the virus and the aggressive action against human cells. Now it's completely confined to the tumor cells that express a molecule called Nestin. Nestin is abundantly expressed in every glioblastoma, but completely absent from the healthy adult brain. That's why we went to recurrent glioblastoma. Basically, glioblastoma will always end up being a recurrent glioblastoma, unfortunately. It has a very poor prognosis. We have shown very encouraging data where we see after just a single injection, doubling of the expected median OS . We replicated this in an independent cohort of patients. We believe we have a medicine here potentially, even after just a single injection. We are now exploring, is there a benefit of giving multiple injections?

We do very deep molecular and immunological analyses, and we are very interested in the question, is there a discrepancy between what you see on CT scans or MRI on the one hand and what you see by the gold standard, which is histology? We took up to six serial biopsies from the brain from these patients after injection of CAN-3110. We are learning a lot about the tissue response to CAN-3110. That's what we're going to present in Q4. We'll have data like transcriptomics, peptidomics, proteomics, what have you, and we'll have data about the discrepancy potentially between imaging and histology as the gold standard. In other words, you'll have data about pseudoprogression, and that will be related to the clinical activity. That will inform the decision, are we going to develop CAN-3110 in recurrent glioblastoma just as a single injection or maybe two injections or more?

We'll have data about this in the near future. At the same time, we are doing enabling, this is an enabling study for other indications outside the brain. We know that there's Nestin overexpression in triple negative breast cancer, in melanoma, in sarcoma, in other tumors. We've started the enabling work also for other indications outside the brain. Next steps, we are preparing a potentially registrational phase two clinical trial for CAN-3110 in glioblastoma. We believe that because of the high unmet need, it would be sufficient potentially to get to approval in a relatively short period of time while we explore the second indication.

Jelena Hromavec
Biotech analyst, Citi Group

I should bring Charles into the conversation before we run out of time. Charles, we've talked a little bit about financing, but if you could summarize the financial situation of the company currently, what you've said as far as your cash outlook and opportunities where you could extend it.

Charles Schoch
CFO, Candel Therapeutics

At the end of the second quarter, we recently in August announced that we had over $100 million of cash on our balance sheet, which effectively funded the company's operations into the first quarter of 2027. We're funded through BLA submission for the prostate cancer program. In the current budget, we are able to do all the enabling work for the non-small cell lung and pancreatic cancer trials as well as CAN-3110. As Paul Peter mentioned, we'll be exploring different ways to bring in non-dilutive financing opportunities, which could be through structured financings or BD opportunities, as well as exploring other equity financings to bring in additional capital to do additional clinical trials in these studies.

Jelena Hromavec
Biotech analyst, Citi Group

In terms of different priorities, when you do have, when you get additional capital, would it go first to the CAN-2409 to some of these studies we've talked about, or where does CAN-3110 fit into the hierarchy in terms of prioritization of the resources?

Charles Schoch
CFO, Candel Therapeutics

Yeah. Based on the data that we have, which are quite unique, we want to do all. We've deprioritized all the programs that are still positive, actually, based on the commercial opportunity, feasibility, regulatory pathway, et cetera. You always need to have a kind of ranking on your mind. That's your question. First, prostate; second, lung; three, pancreatic cancer; four, high-grade glioma. We may be able to find creative solutions for funding, right? The glioblastoma program pays for itself at this time. We'll explore multiple options to make sure that we can also advance CAN-3110. There has been interest also from potential strategic partners, not only to talk about CAN-2409. We always have confidential conversations with mid-size pharma, with large pharma, and we'll choose the right option at the right time. We have also started to have these conversations about CAN-3110.

Jelena Hromavec
Biotech analyst, Citi Group

You mentioned briefly the enLIGHTEN Discovery Platform, and I think you said you had three or maybe more preclinical programs. Are those opportunities for partnering, or you'd want to take those into your IND studies yourself?

Charles Schoch
CFO, Candel Therapeutics

Yeah, it's a great question because we have so much clinical data that we don't speak enough about the enLIGHTEN Discovery Platform, which is a very cost-effective machine, the engine for drug discovery. We have created three preclinical assets at this time. One interferes with the CD47 pathway without the toxicity issues with systemic administration. The second is actually able to induce tertiary lymphoid structures, like immunological organs within tumors. This is like a holy grail in immuno-oncology. The third is a very interesting one because it expresses both IL-12 and IL-15, which is very interesting anti-tumor activity. We are very open to partner programs based on the enLIGHTEN Discovery Platform.

It's actually built for future partnerships because in a relatively short period of time, we can create assets that can be used in combination with medicines in the pipeline of the pharmaceutical industry to convert, for example, non-responders to immune checkpoint inhibitors into responders to help to get CAR T cells into solid tumors, etc . We are very open to discovery partnerships there.

Jelena Hromavec
Biotech analyst, Citi Group

Great. Thank you both so much. Paul Peter, Charles, thank you so much for the time. We look forward to further updates.

Paul Peter Tak
CEO, Candel Therapeutics

Thanks for having us.

Charles Schoch
CFO, Candel Therapeutics

Thank you all.

Powered by