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About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR Delaware 52-2214851 (State or other jurisdiction of incorporation or organization) 117 Kendrick St, Suite 450 Needham, MA 02494 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: (617) 916-54 ...

Exhibit 99.1 Research and Development Expenses: Research and development expenses were $7.0 million for the second quarter of 2025 compared to $5.0 million for the second quarter of 2024. The increase was primarily due to an increase in manufacturing costs in support of the Company's CAN- 2409 programs, partially offset by a decrease in employee-related expenses, which was driven primarily from a reduction in stock-based compensation expense. Research and development expenses included a non-cash stock compe ...

Core Insights - Candel Therapeutics, Inc. reported significant advancements in its clinical programs, particularly for CAN-2409, which received FDA RMAT Designation for prostate cancer treatment and was presented at ASCO [2][4][17] - The company is preparing for a Biologics License Application (BLA) submission for CAN-2409, expected in Q4 2026, and has strengthened its leadership team with new appointments [2][4][12] - Financial results indicate a net loss reduction, with cash reserves sufficient to fund operations into Q1 2027, supporting ongoing clinical development [11][12] Clinical Developments - Positive results from a phase 3 trial of CAN-2409 in localized prostate cancer showed a 30% improvement in disease-free survival compared to placebo [5][17] - CAN-2409 also demonstrated promising outcomes in phase 2a trials for non-small cell lung cancer (NSCLC) and pancreatic cancer, with median overall survival of 24.5 months and 31.4 months, respectively [8][9][17] - The FDA has granted multiple designations to CAN-2409, including Fast Track and Orphan Drug Designation for various cancer indications [4][17] Financial Performance - Research and development expenses increased to $7.0 million in Q2 2025 from $5.0 million in Q2 2024, primarily due to higher manufacturing costs [9] - General and administrative expenses rose to $4.2 million in Q2 2025, up from $3.6 million in Q2 2024, driven by increased commercial readiness costs [10] - The net loss for Q2 2025 was $4.8 million, a significant decrease from $22.2 million in Q2 2024, attributed to changes in the fair value of the company's warrant liability [11] Cash Position - As of June 30, 2025, cash and cash equivalents stood at $100.7 million, slightly down from $102.7 million at the end of 2024, expected to fund operations into Q1 2027 [12][24] - The company completed a direct offering in June 2025, raising approximately $15 million to support pre-commercialization activities [8][17] Corporate Updates - The appointment of Charles Schoch as CFO and Dr. Maha Radhakrishnan to the Board of Directors is expected to enhance the company's strategic direction and operational capabilities [2][8] - Candel plans to host a virtual R&D event in Q4 2025 to discuss ongoing clinical trials and future developments [8]

Summary of Candel Therapeutics (CADL) FY Conference Call - August 13, 2025 Company Overview - **Company**: Candel Therapeutics (CADL) - **Industry**: Biotechnology, specifically focused on cancer immunotherapy Key Points and Arguments Vaccine Approach - Candel's approach involves a novel vaccine strategy that immunizes patients against their own tumors without needing to identify specific antigens [3][4] - Utilizes a replication-defective adenovirus to deliver the HSV thymidine kinase gene, leading to localized enzyme expression and subsequent tumor cell death [4][5] - The process induces a strong pro-inflammatory response, creating optimal conditions for T cell activation against tumors [5][6] Pipeline Focus - Current focus on three main indications: - Early localized nonmetastatic prostate cancer - Borderline resectable pancreatic cancer - Therapy-resistant non-small cell lung cancer (NSCLC) [7][8] Prostate Cancer Data - Positive Phase 3 trial results with a primary endpoint of disease-free survival, showing a 30% improvement in disease-free survival rates [10][12] - Secondary endpoint showed a 38% improvement in prostate cancer-specific disease-free survival [13] - Plans to submit a Biologics License Application (BLA) by 2026 [9][10] Commercial Launch Preparation - Scaling up commercial manufacturing with partner SAFC in California [16][17] - Positive feedback from urologists and radiation oncologists regarding the adoption of CAN 2409 in combination with standard care [18][20] - Initial payer feedback has been favorable, indicating potential cost savings for healthcare systems [21] Non-Small Cell Lung Cancer (NSCLC) Data - Focus on patients with unresectable stage 3 or stage 4 NSCLC who have failed standard treatments [23] - Median overall survival of over 24 months in treated patients, doubling the expected survival [24] - Fast track designation received from the FDA based on these results [26][27] Pancreatic Cancer Data - Conducted a small randomized trial showing a median overall survival of over 32 months compared to 12.5 months in the control group [34] - Fast track and orphan drug designations received from the FDA and EMA [35] Manufacturing and Capacity - Manufacturing process involves replication-defective adenoviruses, similar to COVID-19 vaccines, with established industry capacity [38][39] - Product stability confirmed for over ten years under refrigeration [40] Future Directions - Candel is preparing for a potential registrational Phase 3 trial in therapy-resistant NSCLC and pancreatic cancer [27][35] - Ongoing exploration of CAN 3110, a next-generation oncolytic virus for glioblastoma, showing promising early results [42][45] Financial Position - Current cash runway extends into Q1 2027, with upcoming data announcements expected [53] Additional Important Information - Candel emphasizes the importance of a strong scientific rationale and unmet clinical needs in prioritizing its pipeline [36] - The company aims to advance multiple programs in parallel to maximize commercial value [37]

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 Canaccord Genuity 45th Annual Growth Conference from August 12-14, 2025 [1][2] Company Overview - Candel Therapeutics specializes in off-the-shelf multimodal biological 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] Product Development - CAN-2409 is the lead product candidate from the adenovirus platform, which has completed successful phase 2a trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [4] - A pivotal phase 3 trial of CAN-2409 in localized prostate cancer has been conducted under a Special Protocol Assessment (SPA) with the FDA, and it received Regenerative Medicine Advanced Therapy (RMAT) Designation in May 2025 [4] - CAN-3110 is the lead candidate from the HSV platform, currently in a phase 1b trial for recurrent high-grade glioma (rHGG), and has received Fast Track and Orphan Drug Designations from the FDA [5] Discovery Platform - Candel's enLIGHTEN™ Discovery Platform utilizes human biology and advanced analytics to develop new viral immunotherapies for solid tumors [5]

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 has bureaus and studios in key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2][3] Group 2 - The company is focused on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4] - Automation and software tools, including generative AI, are used, but all content is edited and authored by humans [5]

Core Viewpoint - Candel Therapeutics has received Orphan Designation from the European Medicines Agency (EMA) for its investigational drug CAN-2409 for the treatment of pancreatic cancer, complementing its existing FDA designations, highlighting the significant unmet medical need in this area [1][5]. Group 1: Regulatory Designations - CAN-2409 has received Orphan Drug Designation and Fast Track Designation from the FDA for pancreatic ductal adenocarcinoma (PDAC) [1][5]. - The EMA's Orphan Designation provides benefits such as reduced regulatory fees, clinical protocol assistance, and up to 10 years of market exclusivity in the EU if approved [4]. Group 2: Clinical Trial Results - In a phase 2a clinical trial, CAN-2409 plus valacyclovir showed a median overall survival (OS) of 31.4 months compared to 12.5 months in the control arm, indicating significant survival benefits [3]. - Three out of seven patients treated with CAN-2409 were alive at the data cut-off, with survival times of 66.0, 63.6, and 35.8 months, suggesting a long tail of survival [3]. Group 3: Mechanism of Action - CAN-2409 is a replication-defective adenovirus designed to deliver the HSV-tk gene to tumor cells, leading to immunogenic cell death and the release of tumor antigens [2][6]. - The treatment aims to induce a systemic immune response against multiple therapy-resistant solid tumors, including prostate cancer and non-small cell lung cancer (NSCLC) [2][7]. Group 4: Company Overview - Candel Therapeutics focuses on developing off-the-shelf multimodal biological immunotherapies to elicit individualized anti-tumor immune responses [8]. - The company has established two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 being the lead candidate from the adenovirus platform [8].

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 focuses on sectors such as biotech and pharma, mining and 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]