8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 29, 2022

CANDEL THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware	001-40629	52-2214851
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
117 Kendrick St., Suite 450 Needham, MA		02494
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 916-5445

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.01 par value per share	CADL	The Nasdaq Global Market

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 7.01 Regulation FD Disclosure.

On November 29, 2022, Candel Therapeutics, Inc. (the "Company"), announced it will host a virtual Research and Development (R&D) Day from 11:00 am – 1:30 pm ET on December 6, 2022. The event will provide an extensive overview of the Company’s viral immunotherapy approach and oncology-focused pipeline, with new data being 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.

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.

The information in this Current Report on Form 8-K (including the exhibit) is furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information in the Report that is required to be disclosed solely by Regulation FD.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Press Release dated November 29, 2022
104	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.

	Candel Therapeutics, Inc.
Date: November 29, 2022	By:	/s/ Paul Peter Tak
		Paul Peter Tak, M.D., Ph.D., FMedSci
		President and Chief Executive Officer

EX-99.1

Exhibit 99.1

 

Candel Therapeutics to Host Virtual R&D Day on December 6, 2022

•New clinical data to be presented from the Company’s phase 2 clinical trial of CAN-2409 in combination with anti-PD-1 agents in patients with late-stage non-small cell lung cancer.

•Recent clinical data for CAN-3110 and CAN-2409 in high-grade glioma to be presented.

•Scientific rationale for the recently announced collaboration with the University of Pennsylvania using Candel’s enLIGHTEN™ discovery platform to be discussed.

•Premier experts and thought leaders in immunology and oncology to share perspectives on broad, potential, therapeutic combination synergies and growing opportunity for Candel’s novel viral immunotherapies.

NEEDHAM, Mass., November 29, 2022 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (“Candel” or “the Company”) (Nasdaq: CADL), a clinical stage biopharmaceutical company developing novel viral immunotherapies, today announced it will host a virtual Research and Development (R&D) Day from 11:00 am – 1:30 pm ET on Tuesday, December 6, 2022.

Candel’s first R&D Day will include presentations from its executive leadership, clinical investigators, scientific advisors, and key collaborators. The event will provide an extensive overview of the Company’s viral immunotherapy approach and oncology-focused pipeline, with new data being 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 (NSCLC). The event will conclude with an interactive Q&A session. Click here to register for the event.

The event will include the following presenters:

•Introduction to Candel Therapeutics

oPaul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer, Candel Therapeutics

•Intratumor viral immunotherapy: a new approach to induce systemic anti-tumor immunity

oJames P. Allison, PhD, Regental Professor and Chair of the Department of Immunology, MD Anderson Cancer Center and Director, Parker Institute for Cancer Research

•Clinical perspective on viral immunotherapy

oPadmanee Sharma, MD, PhD, Professor of Genitourinary Medical Oncology and Immunology, MD Anderson Cancer Center

•Phase 2 clinical trial of CAN-2409 treatment in NSCLC

oCharu Aggarwal, MD, MPH, Associate Professor for Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania

oDaniel H. Sterman, MD, Professor and Director, Pulmonary, Critical Care and Sleep Medicine, NYU Langone Health

oRoy Herbst, MD, PhD, Ensign Professor of Medicine, Professor of Pharmacology and Chief of Medical Oncology, Yale Cancer Center

•Phase 1 clinical trial of CAN-2409 combined with nivolumab and standard of care in first-line treatment with high-grade glioma

oPatrick Y. Wen, MD, Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Professor, Neurology, Harvard Medical School

•Phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma

oE. Antonio Chiocca, MD, PhD, Chair, Department of Neurosurgery, Brigham and Women’s Hospital and Professor, Harvard Medical School

•The enLIGHTEN™ Discovery Platform

oFrancesca Barone, MD, PhD, Chief Scientific Officer, Candel Therapeutics

•UPenn – Candel discovery partnership: Combination therapy to overcome CAR-T resistance in solid tumors

oCarl H. June, MD, Richard W. Vague Professor in Immunotherapy and Director, Center for Cellular Immunotherapies and Parker Institute for Cancer Therapy, Perelman School of Medicine, University of Pennsylvania

oNeil C. Sheppard, DPhil, Adjunct Associate Professor of Pathology and Laboratory Medicine, Head of the T Cell Engineering Lab, and Director for Research Technologies and Innovation, Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania

•Interactive Q&A

Registration for this virtual event and access to the live webcast and subsequent replay will be 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.

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 herpes simplex virus (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

Registration Statement on Form S-1, 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

XML

Document and Entity Information	Nov. 29, 2022
Cover [Abstract]
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Entity Central Index Key	0001841387
Document Type	8-K
Document Period End Date	Nov. 29, 2022
Entity Registrant Name	CANDEL THERAPEUTICS, INC.
Entity Incorporation State Country Code	DE
Entity File Number	001-40629
Entity Tax Identification Number	52-2214851
Entity Address, Address Line One	117 Kendrick St
Entity Address, Address Line Two	Suite 450
Entity Address, City or Town	Needham
Entity Address, Postal Zip Code	02494
City Area Code	617
Local Phone Number	916-5445
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Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.01 par value per share
Trading Symbol	CADL
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false