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.
The information contained in Item 8.01 of this Current Report on Form 8-K, to the extent required, is incorporated into this Item 2.02 by reference.
Item 7.01 Regulation FD Disclosure.
On January 13, 2025, Candel Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update, which highlighted the strong pipeline momentum from 2024 and upcoming key value drivers for 2025 and announced its unaudited cash position at December 31, 2024 of $102.9 million.
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 8.01 Other Events.
On January 13, 2025, the Company announced that its unaudited cash position at December 31, 2024 was $102.9 million. This amount is unaudited and preliminary and is subject to the completion of financial closing procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s financial statements as of and for the year ended December 31, 2024.
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: January 13, 2025 |
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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 Provides Corporate Update and Highlights Strong Pipeline Momentum and Key Value Drivers for 2025
NEEDHAM, Mass., January 13, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today highlighted recent successes across the Company's viral immunotherapy portfolio and provided an update on the Company’s cash position and upcoming 2025 milestones.
“I am incredibly proud of the Candel team for their successful execution of our 2024 priorities,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “We demonstrated substantial clinical activity for our investigational medicines and delivered strong results across our pipeline, including positive and pivotal topline phase 3 data for CAN-2409 in intermediate-to-high risk localized prostate cancer, positive topline overall survival data from the phase 2a randomized controlled clinical trial of CAN-2409 in borderline resectable PDAC, as well as topline overall survival data from the open label phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC. We have also reported initial clinical and biomarker activity after repeated injection of CAN-3110 in the ongoing phase 1b clinical trial in rHGG and encouraging data demonstrating
CAN-3110’s potential in a second indication, in a model of melanoma. In 2024, we also presented data on two novel experimental assets generated using Candel’s enLIGHTEN™ Discovery Platform. During the 2024 American Association of Cancer Research (AACR) Annual Meeting, we reported preclinical data for the first-in-class, tertiary lymphoid structure (TLS) inducer viral immunotherapy, and during the 2024 International Oncolytic Virotherapy Conference (IOVC), we presented data on a multimodal immunotherapy that delivers interleukin-12 (IL-12) and interleukin-15 (IL-15) to the tumor microenvironment.”
Dr. Tak continued, “We are entering 2025 with clear momentum. Our primary focus will be achieving BLA readiness for CAN-2409 in prostate cancer. If approved, we believe that CAN-2409 has the potential to become a first-line treatment, as an addition to radiation therapy to reduce the risk of recurrence of prostate cancer, and to redefine the current standard-of-care for prostate cancer patients. In the upcoming months we look forward to collaborating closely with the FDA to ensure alignment in preparation for our BLA submission which, if approved, would enable us to deliver this much-needed therapy to patients.”
2024 Accomplishments
2025 Anticipated Milestones and Key Catalysts
Cash Position
Cash and cash equivalents, as of December 31, 2024, were $102.9 million (unaudited), as compared to $35.4 million (audited) as of December 31, 2023. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will support the preparation and submission of a BLA for CAN-2409 in prostate cancer, as well as fund its current operating plan into Q1 2027.
About CAN-2409
CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging 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. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies.
Currently, Candel is evaluating CAN-2409 in NSCLC, and borderline resectable PDAC, in ongoing clinical trials, and has recently completed phase 2b and phase 3 clinical trials in localized, non-metastatic prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in
prostate cancer was conducted under a Special Protocol Assessment agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC.
About CAN-3110
CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in rHGG, supported by the Break Through Cancer foundation. CAN-3110 has previously received FDA Fast Track Designation and Orphan Drug Designation for the treatment of rHGG.
About the enLIGHTEN™ Discovery Platform
The enLIGHTEN™ Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN™ Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the SITC 2023 Annual Meeting and the 2023 IOVC meeting, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1α pathway, in mouse models of breast cancer and lung cancer. During the AACR Annual Meeting 2024, Candel presented preclinical data, unveiling the second candidate from the enLIGHTEN™ Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce TLS, being developed as a novel therapeutic for solid tumors. Candel presented data at the 2024 IOVC meeting. The presentation focused on a multimodal viral therapeutic candidate encoding IL-12 and IL-15, the latest asset from the platform.
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage
multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and HSV gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in NSCLC (phase 2) and borderline resectable PDAC (phase 2) and recently completed phase 2b and phase 3 clinical trials in localized, non-metastatic prostate cancer. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in rHGG. Finally, 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 current and future development programs, including key data readout milestones and presentations; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s programs, including the ability of CAN-2409 to improve overall survival of patients with intermediate-to-high-risk localized prostate cancer, NSCLC, and pancreatic cancer and the ability of CAN-3110 to treat rHGG and melanoma; the ability of our enLIGHTENTM Discovery Platform to identify new candidates with the potential to alter the lives of patients living with difficult to treat, solid tumors; expectations regarding the potential benefits conferred by orphan drug designation and fast track designation; 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; the Company’s ability to continue as a going concern; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; 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, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC) including the Company’s most recent Quarterly Report on Form 10-Q 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.
Investor Contact
Theodore Jenkins
Vice President, Investor Relations, and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com
Media Contact
Ben Shannon
Vice President
ICR Healthcare
CandelPR@icrhealthcare.com
1 Ling AL, et al. Nature. 2023;623(7985):157-166.