Candel Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. The company's engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection. This is intended to lead to in-situ vaccination against the injected tumor and uninjected distant metastases.

Business Overview

Candel Therapeutics has established two off-the-shelf viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) constructs. The company's most advanced product candidate, CAN-2409, is an off-the-shelf adenovirus product candidate which is administered in conjunction with the prodrug, valacyclovir. CAN-2409 is currently being studied in ongoing clinical trials for prostate cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer.

The company's lead HSV-based product candidate, CAN-3110, is currently in an ongoing investigator-sponsored phase 1b clinical trial in the initial target indication of recurrent high-grade glioma (HGG). Additionally, Candel Therapeutics is designing other novel viral immunotherapy candidates using its proprietary enLIGHTEN™ Discovery Platform, a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics.

Financials

For the fiscal year ended December 31, 2023, Candel Therapeutics reported an annual net loss of $37.9 million, with no revenue generated. The company's annual operating cash flow was -$34.2 million, and its annual free cash flow was -$34.7 million.

In the first quarter of 2024, Candel Therapeutics reported a net loss of $8.2 million. The company's research and development expenses decreased by $1.4 million to $4.1 million, while general and administrative expenses decreased by $0.4 million to $3.8 million. Candel Therapeutics ended the first quarter of 2024 with $25.7 million in cash and cash equivalents.

Liquidity

The company's cash and cash equivalents as of March 31, 2024 were $25.7 million. Candel Therapeutics has determined that there is substantial doubt regarding its ability to continue as a going concern for the one-year period following the date the condensed consolidated financial statements are issued. The company expects to finance its cash needs through a combination of public or private equity or debt financings, government grants, and other sources, which may include collaborations, strategic alliances and licensing arrangements with third parties.

Recent Developments

In November 2023, Candel Therapeutics undertook an organizational restructuring that significantly reduced its workforce by approximately 45%. The company incurred $0.7 million in costs related to severance benefits for the affected employees, including severance payments and limited reimbursement of medical insurance premiums.

Clinical Trials

Candel Therapeutics' most advanced product candidate, CAN-2409, is currently being evaluated in the following ongoing clinical trials:

Prostate Cancer:

- A pivotal phase 3 randomized, triple-blinded and placebo-controlled clinical trial in the United States under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) evaluating 711 evaluable patients with newly diagnosed, localized prostate cancer who have an intermediate or high-risk for progression. The company completed enrollment of this trial in September 2021 and expects to report topline data in the fourth quarter of 2024. - A phase 2 randomized, double blind, placebo-controlled clinical trial in the United States evaluating 187 patients with low-to-intermediate risk, localized prostate cancer undergoing active surveillance. The company completed enrollment of this trial in May 2019 and expects to report topline data in the fourth quarter of 2024.

Non-Small Cell Lung Cancer (NSCLC):

- An open-label phase 2 clinical trial in the United States evaluating CAN-2409 plus valacyclovir in combination with continued PD-(L)1 checkpoint inhibitors in approximately 80 patients with stage III/IV NSCLC who have inadequate response to front line PD-(L)1 checkpoint inhibitor treatments. In April 2023, the FDA granted fast track designation for CAN-2409 plus valacyclovir in combination with pembrolizumab in this patient population.

Pancreatic Cancer:

- A randomized phase 2 clinical trial in the United States evaluating CAN-2409 in borderline resectable and locally advanced pancreatic adenocarcinoma. In March 2023, the company elected to pause new enrollment in this trial, subject to additional funding. However, the company presented initial positive interim overall survival and immunological biomarker clinical data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in the fourth quarter of 2023. In December 2023, the FDA granted fast track designation for CAN-2409 plus valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.

Candel Therapeutics' lead HSV-based product candidate, CAN-3110, is currently in an ongoing investigator-sponsored phase 1b clinical trial in the initial target indication of recurrent HGG. In February 2024, the FDA granted fast track designation for CAN-3110 for the treatment of patients with recurrent HGG to improve overall survival.

The company is also designing other novel viral immunotherapy candidates using its proprietary enLIGHTEN™ Discovery Platform. In October 2022, Candel Therapeutics entered into a collaboration with the University of Pennsylvania (UPenn) Center for Cellular Immunotherapies to study the impact of these novel viral immunotherapy candidates to strengthen the activity of UPenn's investigational CAR-T cell therapies in difficult to treat solid tumors.

Candel Therapeutics currently owns development and commercialization rights for its programs in major markets, including the United States, Europe and Asia, allowing the company to control development and seek approval in those areas as it prepares its commercialization efforts.

Risks and Challenges

The company faces several risks, including the need to obtain regulatory approvals for its product candidates, the potential for clinical trial failures, competition from other therapies, and the need to secure additional funding to continue its operations. Candel Therapeutics will require substantial additional financing to fund its operations and continue to execute its strategy, and it will pursue a range of options to secure additional capital.

Conclusion

Overall, Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative viral immunotherapies to treat various types of cancer. The company's lead product candidates, CAN-2409 and CAN-3110, have shown promising results in ongoing clinical trials, and the company's proprietary enLIGHTEN™ Discovery Platform continues to generate new viral immunotherapy candidates. However, the company faces significant challenges, including the need to obtain regulatory approvals, secure additional funding, and navigate a competitive landscape. Investors should carefully consider the risks and potential rewards associated with Candel Therapeutics as the company continues to advance its pipeline and pursue its strategic objectives.