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|Item 7.01|| |
Regulation FD Disclosure.
On February 22, 2023, Candel Therapeutics, Inc. (the “Company”) has changed the primary endpoint of its randomized, placebo-controlled (active:placebo is 2:1), phase 2 clinical trial of CAN-2409 in patients with low-to-intermediate-risk, localized, non-metastatic prostate cancer undergoing active surveillance to biopsy-proven progression-free survival, where progression is defined as increase in Gleason grade or increase in tumor volume to > 33%. Because of the event-driven nature of this endpoint and the number of events required, additional follow-up time will be required to accumulate a sufficient number of events to detect a reduction in the hazard for progression or death prior to the unblinding of the clinical trial. This change will affect the timing of top line results that were previously guided to be in the fourth quarter of 2023. Based on the current rate of events, the Company currently anticipates top-line results to be available in the fourth quarter of 2024.
The randomized, double-blind, placebo-controlled phase 2 clinical trial (NCT02768363) is evaluating CAN-2409 in patients with localized prostate cancer undergoing active surveillance. The trial is fully enrolled with 187 patients.
The information in Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|Candel Therapeutics, Inc.|
|Date: February 22, 2023||By:|| |
/s/ Paul Peter Tak
|Paul Peter Tak, M.D., Ph.D., FMedSci|
|President and Chief Executive Officer|