We are a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies. Our engineered viruses are designed to induce immunogenic death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection. Our approach combines an in-depth knowledge of viral immunotherapy with extensive clinical experience across a wide range of indications. Based on the broad range of data that we have generated from our preclinical models and clinical trials using our approach, we have observed what we believe to be systemic immune response against locally injected tumors and their distant metastases. We have established two oncolytic viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) constructs. In our clinical results to date from CAN-2409, our lead product candidate from our adenovirus platform, and CAN-3110, our lead product candidate from our HSV platform, we have observed that these candidates may have the potential to address significant unmet patient need and improve clinical outcomes in novel indications across broader patient populations.

Our most advanced product candidate, CAN-2409, is an off-the-shelf adenovirus product candidate combined with the prodrug valacyclovir that has generated promising clinical activity across a range of solid tumor indications, including our lead indication of prostate cancer. We are currently conducting, as part of our most advanced CAN-2409 program, a Phase 3 clinical trial in the United States under a Special Protocol Assessment, or SPA, with the FDA for CAN-2409 in combination with the prodrug valacyclovir in patients with newly diagnosed localized prostate cancer who have an intermediate or high-risk for progression. We expect to complete enrollment for this trial in the third quarter of 2021 with a final data readout in 2024. We are also evaluating CAN-2409 in newly diagnosed high-grade glioma. The FDA has granted CAN-2409 Fast Track designation for use in this setting in combination with standard of care surgery and chemoradiation. We intend to initiate a potential registrational Phase 3 trial in this indication in the first half of 2022.

In addition, we are advancing development of our HSV platform product candidates for different solid tumor indications. Our lead HSV product candidate, CAN-3110, is currently in an ongoing investigator-initiated Phase 1 clinical trial in our initial target indication of recurrent high-grade glioma, and we expect to report additional biomarker results in the fourth quarter of 2021. We are also designing novel candidates based on our HSV platform for the treatment of solid tumors.

(Note: Candel Therapeutics priced its downsized IPO on July 26, 2021, in line with its recently reduced terms: 9 million shares at $8 each to raise $72 million. The company cut its IPO on July 26, 2021, by slashing the price to $8 – down from its initial range of $13 to $15 – and raising the number of shares to 9.0 million – up from 6.07 million shares initially – in an S-1/A filing. The Candel deal’s estimated IPO proceeds are $72 million – down 15.27 percent from its initial estimated IPO proceeds of $84.98 million.)