Candel Therapeutics, Inc. Common Stock Canaccord Genuity's 46th Annual Growth Conference

Thank you, John, and for having us here today. Candel Therapeutics is a biopharmaceutical company, developing off-the-shelf viral immunotherapies. These drugs are aimed at local delivery to achieve systemic immunization.

We have two clinical assets. One is aglatimagene besadenovec, or aglatimagene I would refer to that, and it was also called CAN-2409, so some- of the literature still refer it as that.

That is an off-the-shelf replication-defective adenovirus. It delivers a gene, thymidine kinase. It's given together with a prodrug, and the aim is basically to induce immunization, in situ immunization of the patients against the tumor or antigens. The main indication is localized prostate cancer. We had unveiled in 2024 a positive phase III randomized trial results, where aglatimagene demonstrated superiority around 30% to reduce disease-free survival risk for patients treated with aglatimagene as compared to patient treated with standard of care radiation. This asset is also in development for non-small cell lung cancer. We've completed a phase II study in this indication. We just very recently started recruitment for a new registrational, a potentially registrational phase III study called AURORA in non-small cell lung cancer patients with non-squamous disease that are non-responsive to first-line checkpoint inhibitors.

This is stage 4 disease.

This is the first clinical asset. We have another clinical asset, is a classical oncolytic virus. This is called linoserpaturev, previously known as CAN-3110. This is a classical oncolytic that is the first in class for its modification. It has been modified to selectively replicate within a tumor cell that express the nestin promoter.

This asset has been developed in brain cancer. Both for aglatimagene and for linoserpaturev, we had lots of interactions with the FDA. The phase III trial that I mentioned before for aglatimagene has been developed in prostate cancer under a SPA, Special Protocol Assessment. It received a Fast Track designation, as well as the RMAT designation, and the RMAT designation has been received by the FDA after study readout. With the phase III study readout data, we went to the FDA, and we got RMAT designation. That enables us a very strict communication with the FDA that is extremely useful since we are gearing up to file a BLA for aglatimagene by the end of the year.

linoserpaturev also had Fast Track designation for the development in the brain cancer indication and Orphan Drug Designation as well.

Sure. First of all, as I mentioned before, we've achieved positive, the primary endpoint of the study under the SPA in 2024, where we demonstrated this ability of aglatimagene to delay recurrence of prostate cancer. As a part of the original primary endpoint of this trial, we had the possibility of obtaining biopsies from the patients, and the biopsies were pair biopsies, obviously baseline, and biopsies at 2 years post the end of radiation. This material is extremely interesting because it will enable us to investigate changes that have happened to the tumor microenvironment at the site of injection. What we've done, as part of our presentation at ASTRO, is an AI-enabled digital pathology analysis on the slides of the 2-year post-treatment biopsies that will enable us to really see what changes aglatimagene makes on the top of radiation.

We're going to report the series of histological parameters. We had already disclosed at the time of data readout the ability of aglatimagene to induce an increased number of pathological complete response.

Meaning absence of the tumor at the 2-year biopsy. We had 80% as compared to 63%. That was the data in the control arm. Now we're going to look at this a little bit more in details and using the digital pathology quantification of immune cell aggregates, differential distribution, a series of parameters like, for example, the closeness of the immune cell to the cancer cell. That is a very good readout of some of the mechanistic aspect that then underpin the clinical effect. It is important to say that obviously we had already proof of the mechanism of action of aglatimagene in other indication. We also had it in prostate cancer. We had a very early study in pre-prostatectomy, but this is going to be the first evidence of biological engagement of the immune system at the site of biopsies from the phase III trial.

The process is progressing very well. It's busy. We've been extremely busy, and particularly, I think these past two years have been extremely focused on execution of the elements that we needed to put in place in order to have a successful filing. This has been mainly focused on manufacturing. We had already, just before the study readout, to scale up the manufacturing for the product, for the production of the commercial product to the scale that we're going to use for the commercial product, that is the 200 liters. But there was still quite a bit to do. What was left for us to do was the PPQ campaign, and we can say that we've been extremely successful so far. We are around three quarters down to the PPQ campaign.