Candel Therapeutics(CADL) - 2025 Q2 - Quarterly Results

Corporate Update & Highlights Candel Therapeutics achieved multiple key advancements in Q2 2025, including positive clinical data and regulatory milestones for CAN-2409 across multiple cancer indications Second Quarter 2025 & Recent Highlights Candel Therapeutics achieved multiple key advancements in Q2 2025, including positive clinical data and regulatory milestones for CAN-2409 in prostate, NSCLC, and pancreatic cancer CAN-2409 – Prostate Cancer CAN-2409 showed statistically significant improvement in progression-free survival and received RMAT designation for prostate cancer - In a Phase III clinical trial for localized prostate cancer, CAN-2409 statistically significantly improved progression-free survival by 30% (HR 0.70, p=0.0155) compared to placebo[6] - The FDA granted CAN-2409 Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of newly diagnosed, localized intermediate to high-risk prostate cancer[3][4][6] - The company is on track to prepare the Biologics License Application (BLA) for CAN-2409 in prostate cancer, with submission anticipated in Q4 2026[3][4][6] CAN-2409 – Non-Small Cell Lung Cancer (NSCLC) CAN-2409 demonstrated promising median overall survival in NSCLC patients with inadequate ICI response and induced systemic anti-tumor immunity - In Phase III/IV NSCLC patients (n=46) with inadequate response to ICI therapy, the median overall survival (mOS) was 24.5 months[7] - For patients (n=41) who progressed despite ICI treatment, mOS was 21.5 months, significantly longer than the 9.8–11.8 months reported in literature for standard docetaxel chemotherapy[7] - 69% of patients with multiple lesions observed shrinkage of uninjected tumors, indicating local injection can induce a systemic anti-tumor immune response[7] CAN-2409 - Pancreatic Cancer CAN-2409 demonstrated extended median overall survival in resectable pancreatic cancer and received EMA Orphan Drug Designation - In a Phase IIa clinical trial for resectable borderline pancreatic ductal adenocarcinoma (PDAC), patients receiving CAN-2409 combined with chemoradiation had an mOS of 31.4 months, compared to 12.5 months in the control group[7] - Three patients in the CAN-2409 group (66.0, 63.6, and 35.8 months) were long-term survivors, while only one was in the control group[7] - The European Medicines Agency (EMA) granted Orphan Drug Designation for CAN-2409 for the treatment of pancreatic cancer in July 2025[4][10] Anticipated Milestones & Recent Corporate Events Candel Therapeutics recently completed a private placement, appointed key executives and board members, and announced upcoming clinical data and corporate events - The company completed a private placement in June 2025, issuing approximately 3.2 million shares of common stock and raising approximately $15 million in gross proceeds[10] - Charles Schoch was appointed Chief Financial Officer (CFO), and Dr Maha Radhakrishnan was appointed to the Board of Directors[3][10] - Additional clinical and biomarker activity data from the Phase Ib clinical trial of CAN-3110 in recurrent high-grade glioma (rHGG) patients is expected in Q4 2025[10] - The company plans to host a virtual R&D event in Q4 2025[10] Financial Performance This section details Candel Therapeutics' financial results, including operating expenses, net loss, and cash position for Q2 2025 Second Quarter 2025 Financial Results Candel Therapeutics experienced increased R&D and G&A expenses in Q2 2025, but net loss significantly narrowed due to changes in warrant liabilities' fair value | Metric (thousand dollars) | Q2 2025 | Q2 2024 | Year-over-Year Change | | :--------------------- | :------------- | :------------- | :------- | | Research and Development Expenses | $6,991 | $4,979 | +$2,012 | | General and Administrative Expenses | $4,186 | $3,592 | +$594 | | Total Operating Expenses | $11,177 | $8,571 | +$2,606 | | Operating Loss | $(11,177) | $(8,571) | -$2,606 | | Net Loss | $(4,796) | $(22,237) | +$17,441 | | Basic Net Loss Per Share | $(0.09) | $(0.74) | +$0.65 | - The increase in research and development expenses was primarily due to higher manufacturing costs supporting the CAN-2409 program[8] - The increase in general and administrative expenses was primarily due to commercialization readiness costs and increased professional and consulting fees[9] - The decrease in net loss was primarily related to changes in the fair value of the company's warrant liabilities[11] Cash Position As of June 30, 2025, Candel Therapeutics held $100.7 million in cash and cash equivalents, projected to fund operations through Q1 2027 | Metric (thousand dollars) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------- | :------------- | | Cash and Cash Equivalents | $100,687 | $102,654 | - The company anticipates that its existing cash and cash equivalents will be sufficient to fund operations through Q1 2027, including the BLA submission for CAN-2409 in prostate cancer[4][12] Product Pipeline This section provides an overview of Candel Therapeutics' lead product candidates, CAN-2409 and CAN-3110, detailing their mechanisms of action and clinical progress About CAN-2409 CAN-2409 is Candel's most advanced multimodal biologic immunotherapy, a replication-deficient adenovirus inducing immunogenic cell death and systemic anti-tumor immune responses - CAN-2409 is an investigational, off-the-shelf, replication-deficient adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient's tumor[13] - Its mechanism of action involves the HSV-tk enzyme activity converting a prodrug (valacyclovir) into a DNA-integrating nucleoside analog, leading to immunogenic cell death and inducing individualized, specific CD8+ T-cell mediated responses against both injected and uninjected distant metastases[13] - Over 1,000 patients have been treated with CAN-2409 to date, demonstrating a favorable tolerability profile[13] About CAN-3110 CAN-3110 is a first-in-class, replication-competent HSV-1 next-generation oncolytic viral immunotherapy designed for dual activity through oncolysis and immune activation - CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate[14] - It is designed for dual activity through oncolysis and immune activation[14] - In a Phase Ib clinical trial for rHGG patients, a single injection of CAN-3110 showed improved median overall survival compared to historical controls and was well-tolerated[14] Company Overview & Disclosures This section provides an overview of Candel Therapeutics, its therapeutic platforms, regulatory designations, and important forward-looking statements About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biologic immunotherapies to elicit individualized, systemic anti-tumor immune responses - Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biologic immunotherapies[16] - The company has established two clinical-stage multimodal biologic immunotherapy platforms based on novel genetically modified adenovirus and herpes simplex virus (HSV) gene constructs[16] - CAN-2409 has received RMAT, Fast Track, and Orphan Drug designations, while CAN-3110 has received Fast Track and Orphan Drug designations[17][18] Forward-Looking Statements This press release contains forward-looking statements regarding future development plans, regulatory approvals, therapeutic benefits, and cash flow expectations, subject to risks and uncertainties - Forward-looking statements include, but are not limited to, expectations regarding the timing and progress of current and future development plans, anticipated BLA submission, early biological readouts as predictive indicators of clinical response, anticipated therapeutic benefits of platforms, and expectations regarding cash flow and expenditures[19] - These statements are based on management's current expectations and beliefs and are subject to risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied in the forward-looking statements[20] Investor & Media Contact This section provides Candel Therapeutics' investor relations and media contact information - Investor Contact: Theodore Jenkins, Vice President of Investor Relations and Business Development[21] - Media Contact: Ben Shannon, Vice President, ICR Healthcare[21] Consolidated Financial Statements This section presents Candel Therapeutics' unaudited consolidated financial statements, including statements of operations and balance sheet data Consolidated Statements of Operations This section presents Candel Therapeutics' unaudited consolidated statements of operations for Q2 and six months of 2025 and 2024, detailing key financial metrics | Metric (thousand dollars) | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :---------------------------------- | :------------- | :------------- | :------------- | :------------- | | Research and Development Expenses | $6,991 | $4,979 | $11,007 | $9,081 | | General and Administrative Expenses | $4,186 | $3,592 | $8,300 | $7,392 | | Total Operating Expenses | $11,177 | $8,571 | $19,307 | $16,473 |\ | Operating Loss | $(11,177) | $(8,571) | $(19,307) | $(16,473) |\ | Net Other Income (Expense) | $6,381 | $(13,666) | $21,890 | $(13,985) |\ | Net Income (Loss) | $(4,796) | $(22,237) | $2,583 | $(30,458) |\ | Basic Net Income (Loss) Per Share | $(0.09) | $(0.74) | $0.05 | $(1.03) |\ | Weighted Average Common Shares Outstanding (Basic) | 51,489,929 | 29,878,210 | 50,988,887 | 29,537,874 | Consolidated Balance Sheet Data This section provides Candel Therapeutics' unaudited key consolidated balance sheet data as of June 30, 2025, and December 31, 2024 | Metric (thousand dollars) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------- | :------------- | | Cash and Cash Equivalents | $100,687 | $102,654 |\ | Working Capital | $88,893 | $66,275 |\ | Total Assets | $105,968 | $106,866 |\ | Warrant Liabilities | $1,146 | $21,718 |\ | Total Stockholders' Equity | $90,210 | $66,327 | - Working capital increased from $66,275 thousand as of December 31, 2024, to $88,893 thousand as of June 30, 2025[25] - Warrant liabilities significantly decreased from $21,718 thousand to $1,146 thousand[25] - Total stockholders' equity increased from $66,327 thousand to $90,210 thousand[25]