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
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Item 2.02 Results of Operations and Financial Condition.
On May 11, 2023, Candel Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2023. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is furnished herewith and 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 a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description |
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: May 11, 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 |
Exhibit 99.1
Candel Therapeutics Reports First Quarter 2023 Financial Results and Recent Corporate Highlights
NEEDHAM, Mass., May 11, 2023 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing and commercializing viral immunotherapies to help patients fight cancer, today reported financial results for the first quarter ended March 31, 2023, and provided a corporate update.
“In the first quarter, we continued to advance our off-the-shelf investigational viral immunotherapies designed to produce an individualized cancer response, both of which have shown early clinical promise,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “We are well positioned to announce important catalysts throughout the year. In the near-term, we will present new data from our CAN-3110 glioma clinical trial at ASGCT and we will provide an overview of our non-small cell lung cancer clinical trial design, study protocol, and dosing regimen at ASCO. In addition, we remain on track to announce data from our phase 2 non-small cell lung and pancreatic cancer clinical trials in the second half of the year. We remain steadfast in our mission to improve survival while maintaining quality of life for patients living with cancer.”
First Quarter 2023 & Recent Highlights
Anticipated 2023 Milestones
Financial Results for the Quarter Ended March 31, 2023
Research and Development Service Revenue, related party: Research and development service revenue, related party, was $0 for the first quarter of 2023 compared to $31,000 for the first quarter of 2022.
Research and Development Expenses: Research and development expenses were $5.5 million for the first quarter of 2023 compared to $5.4 million for the first quarter of 2022. The increase was primarily due to manufacturing and regulatory activities in support of the Company’s CAN-2409 programs, offset by lower pre-clinical costs and personnel-related expenses. Research and development expenses included non-cash stock compensation expense of $0.3 million for the first quarter of 2023 compared to $0.1 million for the first quarter of 2022.
General and Administrative Expenses: General and administrative expenses were $4.2 million for the first quarter of 2023 compared to $3.6 million for the first quarter of 2022. The increase was primarily due to increased personnel-related costs, including severance costs. General and administrative expenses included non-cash stock compensation expense of $0.4 million for the first quarter of 2023 compared to $0.3 million for the first quarter of 2022.
Net Loss: Net loss for the first quarter of 2023 was $8.8 million compared to a net loss of $0.9 million for the first quarter of 2022, and included net other income of $0.8 million and $8.1 million, respectively, primarily related to the change in the fair value of the Company’s warrant liability.
Cash Position: Cash and cash equivalents as of March 31, 2023 were $59.3 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the second quarter of 2024.
Candel Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Candel Therapeutics, Inc.
Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on developing and commercializing viral immunotherapies that elicit a systemic anti-tumor immune response to help patients fight cancer. 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 clinical stage viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409, Candel’s lead product candidate from the adenovirus platform, is an off-the-shelf investigational therapy designed to produce an individualized cancer response. CAN-3110 is Candel’s lead product candidate from the HSV platform. Candel’s enLIGHTEN™ Discovery Platform is a 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, including key data readout milestones and presentations; 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; the Company’s ability to raise additional capital; 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 most recent Annual Report on Form 10-K filed with the SEC, 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
Aljanae Reynolds
Director
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
Investor Contact
Sylvia Wheeler
Principal
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com