On November 14, 2024 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, reported financial results for the third quarter ended September 30, 2024, and provided a corporate update (Press release, Candel Therapeutics, NOV 14, 2024, View Source [SID1234648392]).
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"We remain on track for phase 2b and phase 3 topline data in non-metastatic, localized prostate cancer for CAN-2409 in the fourth quarter of 2024, and hope we will deliver the data and regulatory approvals to enable a paradigm shift in how these patients will be treated in the future. We continue to advance our clinical and pre-clinical candidates, while leveraging our robust enLIGHTENTM Discovery Platform to identify new and innovative assets that may be impactful in cancer immunotherapy," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "We are encouraged by the first clinical and biomarker activity data after repeated injection of CAN-3110 from our ongoing phase 1b clinical trial of CAN-3110 in recurrent high-grade glioma, which suggests a long tail of survival. We are also excited about the data that supports potential expansion of CAN-3110 from recurrent high-grade glioma into melanoma, where we observed antitumor activity in pre-clinical models."
Dr. Tak continued, "As to the future, we are also looking forward to reporting updated overall survival data from both our ongoing CAN-2409 phase 2 NSCLC and pancreatic cancer clinical trials in Q1 2025."
Third Quarter 2024 & Recent Highlights
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CAN-3110 – Recurrent High-Grade Glioma
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Received orphan drug designation from the U.S. Food and Drug Administration (FDA) for CAN-3110 for the treatment of recurrent high-grade glioma (rHGG).
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Presented a Trial-in-Progress poster at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on the ongoing phase 1b clinical trial exploring multiple doses of CAN-3110 in patients with rHGG.
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Presented clinical and biomarker activity data from the ongoing phase 1b clinical trial at the 16th Annual International Oncolytic Virotherapy Conference (IOVC).
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In the oral presentation, the investigators reported ongoing improved survival compared to historical controls, with 3 out of 6 patients still alive after more than one year (12.2, 13.0, and 18.7 months, respectively) after initiation of experimental treatment with repeated CAN-3110 injections.
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The data also show discrepancies between imaging and histologic findings, suggesting radiologic pseudo-progression: there was a near absence of tumor cells alongside dense lymphocyte infiltrates in biopsies obtained after CAN-3110 administration, especially in patients with enhancement on post-treatment magnetic resonance imaging (MRI) scans.
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CAN-3110 – Melanoma
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Presented preclinical results on the therapeutic potential of CAN-3110 in the Ras-Raf pathway altered melanoma model at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 39th Annual Meeting.
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CAN-3110 exhibited potent, tumor-specific cytotoxicity in human and murine melanoma cell lines with varied CDKN2A pathway alterations and Nestin expression. In vivo mouse studies showed dose-dependent inhibition of tumor growth, with regression observed in a subset (3 of 8) of tumors treated with a high dose of CAN-3110.
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Cytotoxic activity in melanoma-bearing mice was associated with systemic immune activation, including increased activation and proliferation of circulating T cells.
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Findings mirror those from rHGG patients treated with CAN-3110 reported last year in Nature. The therapy was well-tolerated in preclinical models based on body weight and histopathological analysis following intratumoral administration.
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enLIGHTEN Discovery Platform
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Presented poster titled "A first-in-class multimodal immunotherapy for enhanced immune activation in the tumor microenvironment as a novel therapeutic strategy for solid tumors" at IOVC.
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The presentation focused on the latest asset from the enLIGHTEN Discovery Platform, a multimodal viral therapeutic candidate encoding IL-12 and IL-15. Data showed the ability of the asset to induce expansion and activation of natural killer and CD8+ T cell populations, resulting in significant tumor growth inhibition and regression in two different models.
Anticipated Milestones
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Phase 2b topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024.
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Phase 3 topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024.
Financial Results for Third Quarter Ended September 30, 2024
Research and Development Expenses: Research and development expenses were $5.4 million for the third quarter of 2024 compared to $5.8 million for the third quarter of 2023. The decrease was primarily due to lower payroll-related expenses following the corporate restructuring in the fourth quarter of 2023 and a decrease in depreciation, impairment, and loss on the sale of fixed assets. These decreases were partially offset by clinical development costs driven by increased manufacturing costs for CAN-2409 programs. Research and development expenses included non-cash stock compensation expense of $0.6 million for the third quarter of 2024 compared to $0.3 million for the third quarter of 2023.
General and Administrative Expenses: General and administrative expenses were $3.3 million for the third quarter of 2024 compared to $3.0 million for the third quarter of 2023. The increase was primarily due to increased professional and consulting fees. The increase was partially offset by lower insurance costs. General and administrative expenses included non-cash stock compensation expense of $0.5 million for the third quarter of 2024 compared to $0.4 million for the third quarter of 2023.
Net Loss: Net loss for the third quarter of 2024 was $10.6 million, compared to a net loss of $8.4 million for the third quarter of 2023, and included other expense, net of $1.9 million for the third quarter of 2024 and other income, net of $0.4 million for the third quarter of 2023, primarily due to the change in the fair value of the Company’s warrant liability.
Cash Position: Cash and cash equivalents, as of September 30, 2024, were $16.6 million, as compared to $35.4 million as of December 31, 2023. 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 to the end of the first quarter of 2025.