NEEDHAM, Mass., Feb. 02, 2026 (GLOBE NEWSWIRE) -- 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, today announced that on January 31, 2026, the Compensation Committee of Candel’s Board of Directors (the Board) granted to one new employee, stock options to purchase an aggregate of 6,600 shares of the Company’s common stock, with a per share exercise price of ...

Group 1 - U.S. stocks showed mixed performance, with the Dow Jones increasing by over 600 points on Thursday [1] - Diamond Hill Investment Group Inc's shares surged 45.3% to $170.74 after First Eagle announced an acquisition for $175 per share in a $473 million all-cash deal [1] Group 2 - Planet Labs PBC's stock rose 29.7% to $16.79 following better-than-expected third-quarter sales results and an optimistic fourth-quarter sales guidance [2] - Nextdoor Holdings Inc experienced a gain of 22.9% to $3.11 [2] - Gemini Space Station Inc's shares jumped 19.2% to $13.54 after regulatory approval for its subsidiary to offer prediction markets to U.S. customers [2] - Rhythm Pharmaceuticals Inc's stock increased by 13.5% to $119.00 after announcing preliminary results from a Phase 2 trial for setmelanotide in Prader-Willi syndrome patients [2] - Candel Therapeutics Inc gained 12.4% to $6.52 [2] - VersaBank's shares rose 12.34% to $14.52 [2] - Perpetua Resources Corp's stock increased by 10.4% to $28.37 [2] - iHeartMedia Inc jumped 10.1% to $5.19 [2] - NovaBay Pharmaceuticals Inc gained 9.5% to $2.65 [2] - Idaho Strategic Resources Inc's shares rose 9.3% to $43.62 [2] - Immunovant Inc's stock increased by 8.5% to $25.57 after pricing a $550 million common stock offering [2] - Vail Resorts Inc gained 8.3% to $153.30 following first-quarter results [2] - Mosaic Co's shares surged 7.2% to $25.47 amid higher fertilizer stock prices after reports of Ukraine attacking Russian fertilizer plants [2] - Wayfair Inc's stock rose 6.9% to $99.76 [2] - Centene Corp gained 5.3% to $40.72 [2]

Summary of Candel Therapeutics R&D Day Conference Call Company Overview - **Company**: Candel Therapeutics (NasdaqGM:CADL) - **Focus**: Development of viral immunotherapies for difficult-to-treat solid tumors, specifically CAN-2409 and CAN-3110 [2][5] Key Programs and Clinical Trials CAN-2409 - **Description**: Off-the-shelf immunotherapy targeting pan-solid tumors, particularly localized prostate cancer. - **Clinical Trial**: Phase 3 trial with 745 patients, met primary endpoint of disease-free survival, showing a 30% risk reduction in disease recurrence [2][63]. - **FDA Designations**: Received Fast Track and RMAT designations, indicating significant potential for breakthrough therapy [3]. - **Results**: - 38% reduction in prostate cancer recurrence risk [65]. - 80.4% of patients free of prostate cancer at two years post-radiotherapy [67]. - **Administration**: Involves three courses of intraprostatic injections combined with standard care radiotherapy [62]. CAN-3110 - **Description**: A replication-competent herpes simplex virus designed for oncolytic therapy, targeting recurrent high-grade glioma. - **Results**: Promising data published in high-impact journals, indicating potential for other tumors expressing Nestin [6]. Financial Position - **Cash Reserves**: $87 million as of September 2025, with a runway into Q1 2027 [6]. - **Loan Facility**: Entered a term loan facility with Trinity Capital for up to $130 million [7]. Industry Insights and Future Directions - **Immunotherapy Trends**: Discussion on the importance of understanding immune responses and the need for longitudinal studies to improve patient selection for therapies [19][20]. - **Combination Therapies**: Emphasis on the potential of combining immunotherapies with standard treatments and the need for innovative trial designs to test combinations effectively [40][41]. - **Emerging Technologies**: Interest in RNA vaccines and epigenetic pathways as future avenues for enhancing immunotherapy efficacy [34][36]. Challenges and Considerations - **Clinical Trial Design**: Need for smaller, more adaptive trials to better understand the mechanisms of action and patient responses [44][50]. - **Data Integration**: Importance of integrating computational biology and big data analytics to uncover hidden signals in tumor responses [51][54]. Conclusion - Candel Therapeutics is positioned to address significant unmet needs in cancer treatment, particularly with its lead asset CAN-2409, which has shown promising clinical results. The company is focused on innovative trial designs and combination therapies to enhance treatment outcomes for patients with solid tumors [58][60].

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]

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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]