On May 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 first quarter ended March 31, 2024, and provided a corporate update (Press release, Candel Therapeutics, MAY 14, 2024, View Source [SID1234643211]).
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"It was a catalyst-rich first quarter for Candel, marked by significant advances across both our clinical and preclinical programs," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Notably, as our clinical data mature with long-term follow up, we are beginning to observe highly differentiated results in long-term survival of patients treated with our viral immunotherapies. An example of these clinical results was recently shared in an update of the phase 2 randomized clinical trial of CAN-2409 in patients with borderline resectable pancreatic cancer, where a notable improvement in overall survival, in patients treated with CAN-2409 plus standard of care chemoradiation, was demonstrated compared to chemoradiation alone. The FDA granted CAN-2409 both Fast Track Designation and Orphan Drug Designation for treatment of patients with pancreatic ductal adenocarcinoma to improve median overall survival and treatment of pancreatic cancer, respectively, providing steady momentum to advance this promising investigational treatment for patients with significant unmet medical need."
Dr. Tak continued, "We are also excited to announce that topline overall survival data from our phase 2 clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer and an inadequate response to immune checkpoint inhibitors will be presented at the upcoming ASCO (Free ASCO Whitepaper) meeting in Chicago on Monday, June 3, 2024."
"In addition to our advances in the clinic, we have made great progress with our enLIGHTENTM Discovery Platform. In April 2024, we presented our second drug candidate from this platform, a first-in-class multimodal immunotherapy candidate for induction of tertiary lymphoid structures, in a late-breaking presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We believe this preclinical candidate offers groundbreaking potential in the treatment of cancer," continued Dr. Tak. "We expect to release additional preclinical and clinical data in the coming year, consistent with our commitment to innovation and patient care."
First Quarter 2024 & Recent Highlights
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Program Updates
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CAN-2409 – Pancreatic Cancer
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In early April, announced positive updated survival data, from the ongoing randomized phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable pancreatic ductal adenocarcinoma (PDAC).
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Data showed notable improvements in estimated median overall survival (mOS) of 28.8 months after experimental treatment with CAN-2409 versus 12.5 months in control group.
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At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus 16.7% in the control group after chemoradiation. At 36 months, estimated survival was 47.6% in the CAN-2409 group versus 16.7% in the control group.
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No new safety signals were observed, providing further support that multiple injections of CAN-2409 have been generally well tolerated to date, with no dose-limiting toxicities and no cases of pancreatitis reported.
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Previous analysis of resected tumors showed dense aggregates of immune cells, including CD8+, cytotoxic tumor infiltrating lymphocytes and dendritic cells, in PDAC tissue after CAN-2409 administration, confirming activation of a robust antitumoral immune response.
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Received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAN-2409 for the treatment of pancreatic cancer.
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CAN-2409 – Non-small cell lung cancer (NSCLC)
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Announced a poster titled "Overall survival after treatment with CAN- 2409 plus valacyclovir in combination with continued ICI in patients with stage III/IV NSCLC with inadequate response to ICI" was accepted for the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and will be presented by Charu Aggarwal, MD, MPH, Associate Professor for Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania, on June 3, 2024 in Chicago, IL.
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CAN-3110 – Recurrent High-Grade Glioma (rHGG)
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Received Fast Track Designation from the FDA for CAN-3110 for the treatment of patients with rHGG to improve OS.
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Announced during the 5th Glioblastoma Drug Development Summit in Boston that six patients have been treated with multiple injections (up to six injections) of CAN-3110 in cohort C of the ongoing phase 1b clinical trial, reporting a favorable safety and tolerability profile.
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Announced a Trial-in-Progress poster, titled "Longitudinal stereotactic injections of oncolytic immunoactivating rQNestin34.5v.2 (CAN-3110) with concomitant biopsies for "-omic" analyses in recurrent glioblastoma (GBM)" was accepted for the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and will be presented by David A. Reardon, MD, Professor of Medicine at Harvard Medical School and Clinical Director, Center for Neuro-Oncology at Dana Farber Cancer Institute, on June 1, 2024, in Chicago, IL.
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enLIGHTEN Discovery Platform
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Presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting unveiling the second candidate from the enLIGHTEN Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeutic for solid tumors.
Anticipated Milestones
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Phase 2 topline OS data for CAN-2409 in NSCLC to be presented at ASCO (Free ASCO Whitepaper) on June 3, 2024
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Updated Phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024
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Phase 2 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 First Quarter Ended March 31, 2024
Research and Development Expenses: Research and development expenses were $4.1 million for the first quarter of 2024 compared to $5.5 million for the first quarter of 2023. The decrease was primarily due to lower employee-related expenses following the corporate restructuring in the fourth quarter of 2023 and lower clinical development costs driven by a reduction in regulatory costs for CAN-2409 programs. Research and development expenses included non-cash stock compensation expense of $0.6 million for the first quarter of 2024 compared to $0.3 million for the first quarter of 2023.
General and Administrative Expenses: General and administrative expenses were $3.8 million for the first quarter of 2024 compared to $4.2 million for the first quarter of 2023. The decrease was primarily due to lower employee-related expenses following the corporate restructuring in the fourth quarter of 2023 and lower insurance costs. These decreases were partially offset by increased professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.5 million for the first quarter of 2024 compared to $0.4 million for the first quarter of 2023.
Net Loss: Net loss for the first quarter of 2024 was $8.2 million, compared to a net loss of $8.8 million for the first quarter of 2023, and included other expense, net of $0.3 million and other income, net $0.8 million, respectively. The change from other income, net in the first quarter of 2023 to other expense, net in the first quarter of 2024 was primarily due to the change in the fair value of the Company’s warrant liability and lower interest income.
Cash Position: Cash and cash equivalents, as of March 31, 2024, were $25.7 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 into the fourth quarter of 2024.