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 2.02 Results of Operations and Financial Condition.
On March 30, 2023, Candel Therapeutics, Inc. announced its financial results for the quarter and year ended December 31, 2022. 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
Exhibit Number |
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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: March 30, 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 Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Highlights
in the second half of 2023
NEEDHAM, Mass., March 30, 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 fourth quarter and full year ended December 31, 2022 and provided a corporate update.
“Our 2022 achievements reaffirm our belief that using our viral immunotherapies to mobilize the patient’s immune system to fight cancer represents a promising approach for the treatment of solid tumors,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “Throughout the year, we presented encouraging data, expanded our leadership team, and announced a partnership with the University of Pennsylvania, leveraging Candel’s enLIGHTEN™ Discovery Platform to create novel viral immunotherapies to enhance CAR-T cell therapies in solid tumors. Over the next few quarters of 2023, we anticipate multiple additional clinical data readouts as well as topline data in the fourth quarter of 2024 from our phase 3 clinical trial in early localized prostate cancer. We remain confident in our belief that our investigational medicines have the potential to improve the lives of patients living with cancer.”
“Our investigational viral immunotherapies have shown early clinical promise, including a persistent immune response and have been generally well tolerated,” said W. Garrett Nichols, MD, MS, Chief Medical Officer of Candel. “More specifically, data from our CAN-2409 clinical trial demonstrated robust evidence of local and systemic anti-tumor activity in patients with non-small cell lung cancer who had an inadequate response to immune checkpoint inhibitors. In addition, a single injection of CAN-3110 in patients with recurrent high-grade glioma resulted in a median overall survival of 11.6 months. We are encouraged by these data, which we believe underscore our mission to save, extend and improve the lives of patients through viral immunotherapies.”
Jason A. Amello, Chief Financial Officer of Candel, added, “I am pleased that the prudent and disciplined management of our expenditures and programs has enabled us
to extend our cash runway into the second quarter of 2024, bringing us another quarter closer to our anticipated phase 3 topline data readout for prostate cancer in 2024.”
Fourth Quarter 2022 & Recent Highlights
Anticipated 2023 Milestones
Financial Results for the Fourth Quarter and Full-Year Ended December 31, 2022
Research and Development Service Revenue, related party: Research and development service revenue, related party, for each of the fourth quarters and full-years ended December 31, 2022 and 2021 was $31,000 and $125,000, respectively.
Research and Development Expenses: Research and development expenses were $5.0 million for the fourth quarter of 2022 compared to $3.9 million for the fourth quarter of 2021, and $20.8 million for the full-year 2022 compared to $15.2 million for the full-year 2021. The increase was primarily due to personnel-related costs for additional headcount, as well as operating expenses related to the conduct of four ongoing clinical studies. Research and development expenses included non-cash stock compensation expense of $0.2 million and $0.8 million for the fourth quarter and full-year of 2022, respectively, as compared to a non-cash stock compensation credit of $0.8 million and non-cash stock compensation expense of $1.2 million for the comparable periods in 2021.
General and Administrative Expenses: General and administrative expenses were $3.2 million for the fourth quarter of 2022 compared to $3.9 million for the fourth quarter of 2021, and $14.1 million for the full-year 2022 compared to $10.7 million for the full-year 2021. The increase was primarily due to an increase in insurance expense, recruiting and personnel-related costs, as well as professional and consulting fees associated with operating as a public company. General and administrative expenses included non-cash stock compensation expense of $0.4 million and $1.5 million for the fourth quarter and full-year of 2022, respectively, as compared to $0.4 million and $1.7 million for the comparable periods in 2021.
Net Loss: Net loss for the fourth quarter of 2022 was $5.1 million compared to net income of $1.6 million for the fourth quarter of 2021, and included net other income of $3.0 million and $9.3 million, respectively, related primarily to the change in the fair value of the Company’s warrant liability. Net loss for the full-year 2022 was $18.8 million compared to a net loss of $36.1 million for the full-year 2021, and included net
other income of $15.9 million and net other expense of $10.4 million, respectively, related primarily to the change in the fair value of the Company’s warrant liability.
Cash Position: Cash and cash equivalents as of December 31, 2022 were $70.1 million, as compared to $82.6 million as of December 31, 2021, and reflected the receipt of $20.0 million from the term loan with Silicon Valley Bank in February 2022. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the second quarter of 2024.
Candel Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
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THREE MONTHS ENDED DECEMBER 31, |
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TWELVE MONTHS ENDED DECEMBER 31, |
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2022 |
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2021 |
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2022 |
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2021 |
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Research and development service revenue, related party |
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$ |
31 |
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$ |
31 |
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$ |
125 |
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$ |
125 |
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Operating expenses: |
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Research and development |
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4,972 |
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3,854 |
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20,787 |
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15,178 |
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General and administrative |
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3,160 |
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3,917 |
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14,060 |
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10,673 |
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Total operating expenses |
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8,132 |
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7,771 |
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34,847 |
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25,851 |
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Loss from operations |
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(8,101 |
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(7,740 |
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(34,722 |
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(25,726 |
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Other income (expense): |
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Grant income |
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48 |
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149 |
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48 |
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1,076 |
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Interest and dividend income (expense), net |
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226 |
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(11 |
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(490 |
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(53 |
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Change in fair value of warrant liability |
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2,744 |
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9,198 |
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16,370 |
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(11,421 |
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Total other income (expense), net |
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3,018 |
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9,336 |
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15,928 |
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(10,398 |
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Net income (loss) |
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$ |
(5,083 |
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$ |
1,596 |
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$ |
(18,794 |
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$ |
(36,124 |
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Net income (loss) per share, basic |
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$ |
(0.18 |
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$ |
0.06 |
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$ |
(0.65 |
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$ |
(1.91 |
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Net income (loss) per share, diluted |
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$ |
(0.18 |
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$ |
0.05 |
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$ |
(0.65 |
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$ |
(1.91 |
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Weighted-average common shares outstanding, basic |
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28,899,426 |
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28,689,842 |
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28,823,480 |
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18,873,048 |
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Weighted-average common shares outstanding, diluted |
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28,899,426 |
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34,642,325 |
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28,823,480 |
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18,873,048 |
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Candel Therapeutics, Inc.
Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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DECEMBER 31, |
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DECEMBER 31, |
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Cash and cash equivalents |
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$ |
70,058 |
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$ |
82,642 |
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Working capital (1) |
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66,330 |
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79,583 |
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Total assets |
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77,691 |
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89,205 |
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Warrant liability |
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1,882 |
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18,252 |
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Total other liabilities |
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28,095 |
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6,816 |
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Accumulated deficit |
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(99,089 |
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(80,295 |
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Total stockholders equity |
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$ |
47,714 |
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$ |
64,137 |
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(1) Working capital is calculated as current assets less current liabilities |
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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 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 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.
About CAN-2409
CAN-2409, Candel’s most advanced viral immunotherapy candidate, is a replication-defective adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 950 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in non-small cell lung cancer, pancreatic cancer, and localized, non-metastatic prostate cancer in ongoing clinical trials.
About CAN-3110
CAN-3110 is a herpes simplex virus (HSV) replication-competent viral immunotherapy candidate engineered to enhance selective killing of malignant cells while sparing healthy normal neighboring cells. CAN-3110 has been shown to selectively express ICP34.5, a key gene in HSV replication, in tumor cells that overexpress Nestin, a cytoskeletal protein. Nestin is highly expressed in glioma cells and other tumor tissue,
but is absent in the healthy adult brain. The effects of multiple doses of CAN-3110 in recurrent glioblastoma are currently being evaluated in an ongoing phase 1 clinical trial.
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 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