Candel Therapeutics Q2 2024 Financial Results and Corporate Highlights

Candel Therapeutics, Inc., a clinical-stage biopharmaceutical company, has recently announced its financial results for the second quarter ending June 30, 2024, alongside notable corporate updates. Specializing in multimodal biological immunotherapies, Candel aims to harness the body's immune system to combat cancer.

Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, emphasized the significance of the second quarter of 2024 for the company, stating that it marked a critical period of substantial clinical developments and important regulatory achievements. He highlighted the promising phase 2 data for CAN-2409, which pointed to the potential benefits for patients with non-small cell lung cancer (NSCLC) and borderline resectable pancreatic cancer. Furthermore, the FDA's orphan drug designation for CAN-3110 in recurrent high-grade glioma showcases the potential of Candel's innovative therapies for challenging cancer types.

Critical advancements include the announcement of positive survival data from the phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic ductal adenocarcinoma (PDAC). The data revealed a significant improvement in estimated median overall survival (mOS) of 28.8 months for patients receiving CAN-2409, compared to just 12.5 months for the control group. Additionally, the 24-month survival rate was 71.4% for the CAN-2409 group versus 16.7% for the control group, with no new safety issues reported. These results underscore the therapeutic potential of CAN-2409 and its ability to activate a robust antitumoral immune response.

In another significant development, Candel presented positive topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Patients with stage III/IV NSCLC who were unresponsive to immune checkpoint inhibitors (ICIs) showed a median overall survival of 20.6 months after receiving CAN-2409, compared to less than 12 months with standard docetaxel-based chemotherapy in similar populations. CAN-2409's treatment induced a systemic immune response, enhancing the number of circulating cytotoxic and memory T-cells.

Moreover, the FDA granted orphan drug designation to CAN-3110 for the treatment of recurrent high-grade glioma (rHGG). Candel also presented a poster at the 2024 ASCO Annual Meeting outlining ongoing clinical trials with CAN-3110, which explores multiple dosing regimens in rHGG patients.

Candel's enLIGHTEN™ Discovery Platform also made strides by revealing preclinical data at the American Association for Cancer Research (AACR) Annual Meeting. This platform, designed to develop novel immunotherapies, introduced a new candidate aimed at inducing tertiary lymphoid structures (TLS) in solid tumors.

Corporate milestones include Candel's inclusion in the Russell 3000 Index, effective July 1, 2024, enhancing its visibility within the investment community. Additionally, the company successfully hosted an NSCLC research and development panel during the ASCO Annual Meeting.

Looking ahead, Candel anticipates several key data readouts in the latter part of 2024. These include updated phase 1b data for CAN-3110 in rHGG, phase 2b topline data for CAN-2409 in localized prostate cancer, and phase 3 disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer.

From a financial perspective, Candel reported that research and development expenses for the second quarter of 2024 were $5.0 million, down from $5.9 million in the same period in 2023, mainly due to reduced clinical development and payroll-related costs. General and administrative expenses remained steady at $3.6 million. However, the net loss for the second quarter of 2024 was $22.2 million, an increase from $9.6 million in the second quarter of 2023, primarily driven by changes in the fair value of the company’s warrant liability.

As of June 30, 2024, Candel had $21.5 million in cash and cash equivalents, a decrease from $35.4 million as of December 31, 2023. The company expects its current cash reserves to fund its operations into the first quarter of 2025.

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