Candel Therapeutics(CADL) - 2025 Q3 - Quarterly Report

Financial Performance - The net loss for the three months ended September 30, 2025, was $11,269,000, compared to a net loss of $10,646,000 for the same period in 2024, indicating an increase in loss of about 5.9%[25] - The company reported a net loss of $8.7 million for the nine months ended September 30, 2025, compared to a net loss of $41.1 million for the same period in 2024, representing a 78.8% improvement[36] - For the three months ended September 30, 2025, the net loss was $11.27 million, resulting in a net loss per share of $0.21, compared to a net loss of $10.65 million and a net loss per share of $0.33 for the same period in 2024[99] - The net loss for Q3 2025 was $11.3 million, compared to a net loss of $10.6 million in Q3 2024, reflecting an increase in operational losses[166] Assets and Liabilities - Total current assets decreased from $103,804,000 as of December 31, 2024, to $90,134,000 as of September 30, 2025, a decline of approximately 13.2%[22] - Total liabilities decreased significantly from $40,539,000 as of December 31, 2024, to $13,474,000 as of September 30, 2025, representing a reduction of about 66.8%[22] - Cash and cash equivalents decreased from $102,654,000 as of December 31, 2024, to $86,963,000 as of September 30, 2025, a decline of about 15.3%[22] - As of September 30, 2025, the company had cash and cash equivalents of $87.0 million and $5.2 million of debt[180] Equity and Stock - The total stockholders' equity increased from $66,327,000 as of December 31, 2024, to $80,124,000 as of September 30, 2025, reflecting a growth of approximately 20.8%[22] - The weighted-average common shares outstanding increased from 32,013,569 for the three months ended September 30, 2024, to 54,894,347 for the same period in 2025, an increase of approximately 71.5%[25] - The Company has reserved 15,657,328 shares of common stock for future issuance as of September 30, 2025, down from 17,666,380 shares as of December 31, 2024, representing a reduction of approximately 11.4%[71] - The Company has 8,558,685 shares reserved under the 2021 Equity Incentive Plan, with 1,939,396 shares remaining available for future grants as of September 30, 2025[83] Research and Development - Research and development expenses increased to $8,461,000 for the three months ended September 30, 2025, compared to $5,416,000 for the same period in 2024, marking a rise of approximately 56.5%[25] - The Company recorded a total stock-based compensation expense for the nine months ended September 30, 2025, was $2.5 million, compared to $4.1 million for the same period in 2024[88] - Research and development expenses increased by $5.0 million from $14.5 million in the nine months ended September 30, 2024, to $19.5 million in the nine months ended September 30, 2025, primarily due to a $4.2 million increase in clinical development costs[173] - Research and development expenses increased by $3.0 million from $5.4 million in Q3 2024 to $8.5 million in Q3 2025, primarily due to increased manufacturing and regulatory costs for CAN-2409 programs[167] Financing Activities - The company raised approximately $14.3 million from the issuance of common stock in a registered direct offering on June 25, 2025[39] - The company completed a public offering on December 16, 2024, raising approximately $92.0 million before deducting underwriting discounts and commissions[38] - The company raised approximately $291.6 million in gross proceeds from various financing activities, including $207.6 million from the sale of common stock[179] - The company entered into a Loan and Security Agreement on October 14, 2025, with an aggregate principal amount of up to $130.0 million, with the first tranche of $50.0 million drawn down at closing[189] Future Outlook - The company expects to continue generating operating losses and negative cash flows for the foreseeable future[36] - The company believes existing resources will fund planned operations for at least 12 months from the issuance date of the financial statements[41] - The company anticipates significant future funding requirements to support ongoing research, development, and commercialization efforts[207] - The company expects operating expenses to increase substantially as it advances clinical development and prepares for potential commercialization of product candidates[204][206] Clinical Trials and Product Development - The company has established two off-the-shelf viral immunotherapy platforms, with product candidates CAN-2409 and CAN-3110 currently in clinical trials[34] - CAN-2409 demonstrated a statistically significant improvement in disease-free survival (DFS) with a median DFS not reached for the treatment arm compared to 86.1 months in the placebo arm (p=0.0155; HR 0.70; 95% CI: 0.52 to 0.94) in a phase 3 trial involving 745 patients[117] - The phase 3 trial showed a 67.1% rate of patients achieving a prostate-specific antigen (PSA) nadir (<0.2 ng/ml) in the CAN-2409 arm compared to 58.6% in the placebo arm (p=0.0164) and an 80.4% pathological complete response rate in post-treatment biopsies versus 63.6% in the control arm (p=0.0015)[118] - The ongoing phase 1b trial of CAN-3110 for recurrent high-grade glioma (HGG) received Fast Track Designation from the FDA in February 2024, aiming to improve overall survival[120] Internal Controls and Compliance - Management is responsible for establishing and maintaining adequate internal control over financial reporting[220] - Disclosure controls and procedures are designed to ensure timely recording and reporting of required information[220] - Controls provide reasonable assurance of achieving their objectives, acknowledging that no system can guarantee complete effectiveness[220] - Management applies judgment in evaluating the cost-benefit relationship of possible controls and procedures[220]