Candel Therapeutics, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Welcome, gentlemen. Thank you very much.

Thanks. Great. A perfect primer to start is for investors less familiar with Candel Therapeutics' story.

Could you briefly walk us through the pipeline and company priorities over the next 12 to 18 months?

Yeah, absolutely. Candel Therapeutics develops viral immunotherapies for difficult-to-treat solid tumors, and we have two investigational medicines in the clinic. The first is called aglatimagene, and we have positive phase III data pivotal trial in newly diagnosed localized prostate cancer. Area of huge unmet need. These patients that we focus on are treated with curative intent, and we try to increase the proportion of patients that will actually live free from evidence of recurrence of cancer. We have achieved that. We have achieved the primary endpoint supported by secondary and exploratory endpoints, and we are now preparing BLA submission. We're aiming for BLA submission at the end of this year, so that's the major catalyst. The interesting thing about aglatimagene is it's a bone solid tumor immunotherapy.

We also have positive data in other indications that are difficult to treat, like therapy-resistant metastatic progressive non-small cell lung cancer. We have done a very interesting phase II-A study where we could show doubling of expected median overall survival in patients who had failed immune checkpoint inhibitors. We expect that the data will be published shortly in a scientific journal. We've started a global phase III clinical trial, pivotal trial in non-small cell lung cancer. We also have positive data in pancreatic cancer based on a small randomized controlled clinical trial in borderline resectable pancreatic cancer. You see a complete separation of the overall survival curves. We got Fast Track designation there, Orphan Drug designation. We've paused the program, however, because we have just too much, and we need to have a laser focus on value creation, but the program is still there.

Then we will have new data for the aglatimagene in prostate cancer program in the near future. We've said we expect immunological biomarker data in Q3, and we may come back to this. The second investigational medicine is called linoserpaturev. Unlike aglatimagene, this is a true oncolytic virus, but it's a next generation replication-competent herpes simplex virus that is designed to replicate only in the tumor cells while sparing the healthy tissue. We test it in probably the most difficult to treat form of cancer, which is recurrent glioblastoma. We have very encouraging data there as well. We published this in Nature and more recently in Science Translational Medicine, and we are preparing a randomized control trial. We also expect in Q4 to come back to the catalyst. The question, are there any patients who live much longer than you would expect?

Keep in mind that all these patients typically die within 6 to 9 months. We're looking at the long tail of survival. I should mention that this is also an enabling indication for other tumors outside the brain. Think of sarcoma, gastrointestinal tumors, triple-negative breast cancer. We are creating another pipeline in a product at the right time, similar to what we've done for aglatimagene.

Yeah, it's a great question. Let me first say the following. 3 years ago, we had a market cap of less than $50 million, and 1 week ago, we had a market cap of $1 billion. Institutional ownership has gone up to about 70%, if you include some of the key insiders like PBM Capital, but probably getting close to 80%. We are in a much better position than we are. At the same time, I also agree with you. I think this is still hugely undervalued, and the reasons include this is a completely new modality. It's even not an oncolytic virus, so people sometimes found it difficult to get their head around it. People have not seen any study that was focused on patients with localized prostate cancer treated with curative intent, so it's a completely new indication.

People have not seen the use of disease-free survival as a primary endpoint for regulatory approval in prostate cancer. It has been used in other indications like breast cancer, other diseases, because there's been no successful treatment in the past for localized disease in patients who want to live free from cancer, free from local progression of the disease, free from metastases, free from long-term toxic treatments like long-term ADT, like this chemical castration. I think people did not get that immediately. But that also means that this is a vertical investment opportunity. I've estimated, and I've said this in public before, the probability of success ultimately for approval to be in the order of 90%, 90.

Everybody can use their own favorite AI system to ask the question, if there's a pivotal phase III study, placebo-controlled trial that achieved the primary endpoint supported by secondary and exploratory endpoints, conducted under a Special Protocol Assessment agreed with the FDA that's intact, that got an RMAT designation after data read-out. But it's more or less the probability of success. In the end, it's always 0% or 100%, right? You get it or not, but this is how we think about it. We do believe that this is an asymmetrical investment opportunity, but we are happy with where we are. A very clear trajectory upwards.

Yeah. If a patient has intermediate or high-risk prostate cancer, and the decision is to undergo radical treatment because these patients want to eradicate that tumor, just think about it through the patient perspective, right? If you're diagnosed with cancer, you want to get rid of your cancer. You're not necessarily thinking about with a slowly growing tumor, will I be alive in 20 years? Also important, because if you don't have cancer anymore, you won't die because of prostate cancer 15 or 20 years later. But you want to have the immediate elimination. This is a patient population that has made that decision to accept the complications and side effects of either radical prostatectomy surgery or radiotherapy. Think of urinary incontinence, erectile dysfunction, loss of quality of life, what have you.