UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On December 12, 2023, Candel Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration granted Fast Track Designation for its lead adenovirus asset, CAN-2409, an investigational viral immunotherapy, plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma to improve overall survival.
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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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Candel Therapeutics, Inc. |
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Date: December 12, 2023 |
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By: |
/s/ Paul Peter Tak |
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Paul Peter Tak, M.D., Ph.D., FMedSci |
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President and Chief Executive Officer |