Summary of Candel Therapeutics Conference Call Company Overview - **Company**: Candel Therapeutics (NasdaqGM:CADL) - **Focus**: Development of viral immunotherapies for difficult-to-treat cancers, specifically targeting solid tumors [2][3] Key Products CAN-2409 - **Type**: First-in-class in situ vaccination for solid tumors - **Administration**: Requires only 2-3 administrations in a patient's lifetime to achieve durable anti-tumor immunity [3][10] - **Clinical Trials**: - **Phase III Trial**: Conducted in newly diagnosed localized prostate cancer, meeting primary endpoint with a 30% improvement in disease-free survival [17][18] - **Secondary Endpoint**: Achieved a 38% improvement in prostate cancer-specific disease-free survival [18] - **Pathological Complete Response**: 80.4% in CAN-2409 group vs. 63.6% in control group [18] - **FDA Designations**: Fast-track and orphan drug designations for prostate and pancreatic cancers [3][4] CAN-3110 - **Type**: Next-generation oncolytic virus targeting recurrent high-grade glioma - **Mechanism**: Replication-competent herpes simplex virus that selectively replicates in tumor cells [4][26] - **Clinical Data**: Early results show long-term survival in patients with recurrent glioblastoma, with some surviving over 59 months post-treatment [28][29] Financial Position - **Funding**: Recently secured a deal with Trinity Capital for up to $130 million to support clinical trials [22] - **Equity Deals**: Raised funds in December and the first half of the current year [5] Clinical Strategy - **Target Population**: Focus on patients with intermediate or high-risk prostate cancer who prefer curative options over radical surgery or radiotherapy [11][12] - **Trial Design**: Randomized controlled trials with a focus on disease-free survival as the primary endpoint [14][20] - **Patient Experience**: Administration of CAN-2409 is less traumatic than standard biopsies, with most patients reporting it as better tolerated [16][19] Future Plans - **BLA Submission**: Planned for Q4 next year, with ongoing preparations for commercial manufacturing and pre-commercialization activities [20][21] - **Upcoming Trials**: Phase III trial for CAN-2409 in non-small cell lung cancer to start in Q2 next year [24][30] - **Data Generation**: Continued follow-up on prostate cancer trial patients and new data on CAN-3110 expected [30] Important Insights - **Market Position**: Candel Therapeutics is positioned uniquely in the market with no direct competition in the newly diagnosed localized prostate cancer space [11] - **Long-term Survival**: Promising data on long-term survival rates in patients treated with CAN-3110, indicating potential for significant advancements in treatment options for glioblastoma [28][29] - **Scientific Rigor**: Emphasis on independent peer review and collaboration with leading experts in oncology to ensure high-quality research and development [6][30]

Core Insights - Candel Therapeutics, Inc. will host a virtual Research and Development (R&D) Event on December 5, 2025, focusing on its viral immunotherapy approach and oncology pipeline [1][2] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [11][12] - The company has two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 as the lead candidate from the adenovirus platform [12][13] R&D Event Details - The R&D Day will feature presentations from executive leadership, clinical investigators, and scientific advisors, providing an overview of the company's pipeline [2] - Key presentations will include an introduction by Paul Peter Tak, CEO, and discussions on immuno-oncology innovations [2][3] Product Candidates - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene to tumors, showing potential for treating a broad range of solid tumors [9] - More than 1,000 patients have been dosed with CAN-2409 in clinical trials, demonstrating a favorable tolerability profile [9][12] - CAN-3110 is a first-in-class, replication-competent HSV-1 oncolytic viral immunotherapy candidate, currently in a phase 1b clinical trial for recurrent high-grade glioma [10][13] Clinical Trials and Regulatory Designations - Candel has completed successful phase 2a trials for CAN-2409 in non-small cell lung cancer and pancreatic ductal adenocarcinoma, and a pivotal phase 3 trial in localized prostate cancer [12] - The FDA has granted Fast Track and Regenerative Medicine Advanced Therapy Designations to CAN-2409 for various cancer treatments [12]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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]

Core Insights - Candel Therapeutics reported strong progress in its clinical pipeline and plans to submit a Biologics License Application (BLA) for CAN-2409 in Q4 2026 [2][4][10] Financial Results - For Q3 2025, research and development expenses were $8.5 million, up from $5.4 million in Q3 2024, primarily due to increased manufacturing and regulatory costs [11] - General and administrative expenses rose to $4.7 million in Q3 2025 from $3.3 million in Q3 2024, driven by higher commercial readiness costs [12] - The net loss for Q3 2025 was $11.3 million, compared to a net loss of $10.6 million in Q3 2024 [13] - Cash and cash equivalents as of September 30, 2025, were $87.0 million, down from $102.7 million at the end of 2024, but expected to fund operations into Q1 2027 [14][26] Clinical Developments - Candel presented positive data from the phase 3 trial of CAN-2409 in localized prostate cancer, showing improved disease-free survival (DFS) [4][6] - The company plans to initiate a pivotal phase 3 trial of CAN-2409 in non-small cell lung cancer (NSCLC) in Q2 2026 [4][10] - Encouraging survival data from the phase 1b trial of CAN-3110 in recurrent high-grade glioma (rHGG) was reported, with updated median overall survival of 11.8 months [4][10][20] Strategic Initiatives - Candel secured a $130 million term loan facility with Trinity Capital, with $50 million drawn at closing, to support its clinical trials and operations [2][4][10] - The company strengthened its Research Advisory Board with the appointments of Dr. Carl H. June and Dr. Bali Pulendran, enhancing its commitment to scientific excellence [2][4][10] Upcoming Milestones - The company anticipates updated data on long-term survivors from its phase 2 study in NSCLC in Q1 2026 and plans to submit the BLA for CAN-2409 in prostate cancer in Q4 2026 [8][10]

Core Insights - Candel Therapeutics is set to present three key studies at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, highlighting its advancements in cancer immunotherapy [1][2][3] Company Developments - Candel's presentations will showcase its leadership in developing novel therapeutics that utilize multi-omics insights and artificial intelligence to enhance understanding of tumor microenvironments and biomarkers [2][3] - The company plans to submit a Biologics License Application (BLA) for its lead product candidate, CAN-2409, for the treatment of newly diagnosed localized prostate cancer in Q4 2026 [4][8] Clinical Trial Results - Positive phase 3 clinical trial data for CAN-2409 in localized prostate cancer will be presented, achieving its primary endpoint and supported by secondary endpoints [4][8] - A phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer (NSCLC) will also be discussed, integrating over 3,000 data points to understand clinical and biological responses [6][9] Key Findings - In the NSCLC trial, patients with non-squamous histology showed greater immune response and improved survival compared to those with squamous histology, supporting further investigation in this subgroup [7][14] - The enLIGHTEN™ Discovery Platform demonstrated a 60% tumor growth suppression in preclinical models, indicating its potential for precision immunotherapy design [10][15] Product Information - CAN-2409 is an investigational, off-the-shelf biological immunotherapy designed to induce a systemic anti-tumor immune response, with over 1,000 patients dosed in clinical trials showing a favorable tolerability profile [12][16] - The enLIGHTEN™ Discovery Platform aims to create new multimodal biological immunotherapies by leveraging human biology and advanced analytics [18]

Core Insights - Candel Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies for cancer treatment [3][4] - The company will present at the Jefferies Global Healthcare Conference on November 18, 2025 [1][2] Company Overview - Candel specializes in off-the-shelf, multimodal viral immunotherapies that aim to elicit individualized, systemic anti-tumor immune responses [3] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [3] Clinical Trials and Designations - Candel has completed successful phase 2a clinical trials for its lead product candidate CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [4] - CAN-2409 has received Fast Track Designation from the FDA for treating PDAC and stage III/IV NSCLC in specific patient populations [4] - The FDA has also granted Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation to CAN-2409 for localized prostate cancer and PDAC, respectively [4] Additional Product Candidates - CAN-3110, the lead candidate from the HSV platform, is currently in a phase 1b clinical trial for recurrent high-grade glioma and has received Fast Track and Orphan Drug Designations from the FDA [5] - Candel's enLIGHTEN™ Discovery Platform is designed to create new viral immunotherapies for solid tumors using advanced analytics [5]

Core Insights - Candel Therapeutics has secured a $130 million term loan facility with Trinity Capital, which is a significant development for the company [1][2] - The non-dilutive funding will primarily support the BLA submission for CAN-2409, the company's lead asset in prostate cancer, and aid in commercialization efforts [2][3] Financial Developments - The loan facility is structured to allow an immediate drawdown of $50 million upon closing, with access to remaining funds contingent on meeting specific milestones [5] - This financing strategy is designed to avoid unnecessary dilution for shareholders while providing the necessary capital for ongoing projects [3][5] Strategic Focus - Candel is prioritizing its lead asset CAN-2409 for prostate cancer, followed by therapy-resistant non-small cell lung cancer, and has decided to pause the launch of a large clinical program in pancreatic cancer to manage resources effectively [6][7] - The company has completed enabling work for its programs and received orphan drug designation from both the EMA and FDA, indicating readiness to advance once additional funding is secured [8] Partnership Opportunities - Candel is actively exploring strategic partnerships to secure further non-dilutive funding, with ongoing discussions with potential partners showing significant interest [9][10] - The company emphasizes the importance of entering into agreements that align strategically with its goals, ensuring that any partnership is beneficial for its long-term objectives [10]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Candel Therapeutics has appointed Dr. Bali Pulendran to its Research Advisory Board, enhancing its expertise in systems immunology and vaccinology as it advances its viral immunotherapy candidates [1][2][3] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal viral immunotherapies to elicit systemic anti-tumor immune responses [4] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4] Product Development - Candel's lead product candidate, CAN-2409, has completed successful phase 2a clinical trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5] - A pivotal phase 3 clinical trial of CAN-2409 in localized prostate cancer is underway, conducted under a Special Protocol Assessment (SPA) with the FDA [5] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including PDAC and stage III/IV NSCLC [5] - CAN-3110, the lead candidate from the HSV platform, is currently in a phase 1b clinical trial for recurrent high-grade glioma and has also received Fast Track and Orphan Drug Designations from the FDA [6] Research and Development - Dr. Pulendran's expertise is expected to provide valuable insights into the immune system's response to therapies, aiding in the advancement of CAN-2409 and CAN-3110 [2][3] - Candel's enLIGHTEN™ Discovery Platform leverages human biology and advanced analytics to create new viral immunotherapies for solid tumors [6]