UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 8.01 Other Events.
On December 6, 2022, Candel Therapeutics, Inc. (the "Company"), hosted a virtual Research and Development (R&D) Day. The event provided an extensive overview of the Company’s viral immunotherapy approach and oncology-focused pipeline, with new data presented from its phase 2 clinical trial of CAN-2409 in combination with anti-PD-1 agents in patients with stage III/IV non-small cell lung cancer, as well as an update on its phase 3 clinical trial of CAN-2409 in high-grade glioma.
A copy of the full press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
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 thereunto duly authorized.
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Candel Therapeutics, Inc. |
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Date: December 6, 2022 |
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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 |
Exhibit 99.1
Candel Therapeutics R&D Day Presentations Spotlight its Advanced Pipeline and Capabilities to Develop Novel Viral Immunotherapies for Patients with Cancer
NEEDHAM, Mass., December 6, 2022 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (“Candel” or “the Company”) (Nasdaq: CADL), a clinical stage biopharmaceutical company developing novel viral immunotherapies, today held its Research and Development Day to provide an extensive overview of the Company’s unique viral immunotherapy platforms and to review updated clinical data from its oncology-focused pipeline.
“We are proud to present data and a growing body of evidence from our clinical stage pipeline,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “The totality of clinical data demonstrates that CAN-2409 and CAN-3110 are active investigational viral immunotherapies with robust biomarker evidence of local and systemic immune responses. We look forward to advancing our product candidates through the next phase of clinical development towards registration and beyond to bring important treatment options to patients in need.”
Candel provided updates on a broad range of its programs. Highlights included:
Phase 2 clinical trial of CAN-2409 in non-small cell lung cancer
Phase 1 clinical trial of CAN-3110 in recurrent HGG
Phase 1 clinical trial of CAN-2409 in combination with nivolumab in HGG
Reaffirmed guidance of phase 2 and 3 clinical trials of CAN-2409 in prostate cancer
enLIGHTEN Discovery Platform launched
Corporate highlights
The recorded webcast is accessible under “Events and Presentations” on the Investors page of the Company’s website at https://ir.candeltx.com/news-and-events/events-and-presentations or by clicking here. A replay of the event will be available for up to a year.
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on helping patients fight cancer with viral immunotherapies. Candel’s engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens while creating a pro-inflammatory microenvironment at the site of injection. Candel has established two viral immunotherapy platforms based on novel, genetically modified adenovirus and HSV constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. Candel’s enLIGHTEN™ Discovery Platform is the first systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
For more information about Candel, visit: www.candeltx.com
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s Quarterly Report on Form 10-Q filed on November 10, 2022, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Media Contact
Cassidy McClain
Account Director
Evoke Canale
Cassidy.McClain@evokegroup.com
(619) 694-6291
Investor Contact
Sylvia Wheeler
Principal
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com