Candel Therapeutics Files 8-K

TL;DR

Candel Therapeutics filed a standard 8-K, no major news.

AI Summary

Candel Therapeutics, Inc. filed an 8-K on May 23, 2024, to report on other events and financial statements. The filing does not contain specific details about new material events or financial performance in this particular report, but serves as a standard disclosure.

Why It Matters

This filing indicates Candel Therapeutics is making a required disclosure to the SEC, which is standard practice for publicly traded companies.

Risk Assessment

Risk Level: low — This filing is a routine disclosure and does not contain information that inherently increases or decreases risk.

Key Players & Entities

• Candel Therapeutics, Inc. (company) — Registrant
• May 23, 2024 (date) — Date of earliest event reported
• Needham, MA (location) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.01 — nge on which registered Common Stock, $0.01 par value per share CADL The Nasdaq

Filing Documents

• cadl-20240523.htm (8-K) — 51KB
• cadl-ex99_1.htm (EX-99.1) — 49KB
• img160460863_0.jpg (GRAPHIC) — 32KB
• img160460863_1.jpg (GRAPHIC) — 39KB
• 0000950170-24-064022.txt ( ) — 328KB
• cadl-20240523.xsd (EX-101.SCH) — 28KB
• cadl-20240523_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On May 23, 2024, Candel Therapeutics, Inc. (the "Company") issued a press release reporting data that showed a prolonged overall survival in the Company's phase 2 clinical trial of CAN-2409 for advanced non-small cell lung cancer ("NSCLC") patients non-responsive to immune checkpoint inhibitor ("ICI") treatment. As previously announced, the Company will present the data at the 2024 American Society of Clinical Oncology ("ASCO") Annual Meeting on June 3, 2024. A copy of the full press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K are furnished and shall not be deemed to be "filed" for the 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. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in any such filing.

01 Other Events

Item 8.01 Other Events. On May 23, 2024, the Company announced topline data that showed a prolonged overall survival in the Company's phase 2 clinical trial of CAN-2409 plus valacyclovir, together with ICI therapy in patients with Stage III/IV NSCLC inadequately responding to ICI (anti-PD-L1) therapy (as of an April 1, 2024 data cut-off): Median overall survival ("mOS") of 20.6 months was observed following two administrations of CAN-2409 plus valacyclovir in NSCLC patients with progressive disease despite ICI therapy, compared to published results of median overall survival of 11.6 months observed with standard of care docetaxel-based chemotherapy in a similar patient population. Improved mOS was observed in both PD-L1 negative and PD-L1 positive tumors in patients with progressive disease (N=37 patients in cohort 2 for which PD-L1 status at baseline was available). mOS of 22.0 months was observed across all patients (n=46) who had an inadequate response to ICI. CAN-2409 treatment resulted in activation of the systemic immune response after two administrations of CAN-2409, including increased numbers of circulating cytotoxic and memory T cells, which significantly correlated with subsequent prolonged survival and a beneficial effect on both injected and uninjected tumors (abscopal response). As of the data cut-off date, CAN-2409 treatment in NSCLC continued to exhibit a favorable safety and tolerability profile. 71.4% of patients with metastatic disease and at least one uninjected tumor (n=35) experienced a beneficial effect from CAN-2409 treatment on both injected and uninjected tumors, indicating a systemic anti-tumor immune response. When using a threshold of >5% decrease, more than 60% of patients showed an abscopal response. Increased numbers of circulating CD8+ cytotoxic and CD4+ effector and central memory T cells as well as elevated levels of soluble granzymes B and H after the second CAN-2409 injection were associated with subsequent prolonged

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description 99.1 Press Release dated May 23, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES 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 hereunto duly authorized. Candel Therapeutics, Inc. Date: May 23, 2024 By: /s/ Paul Peter Tak Paul Peter Tak, M.D., Ph.D., FMedSci President and Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR