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 ...

NEEDHAM, Mass., May 28, 2025 (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 the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company’s biological immunotherapy lead candidate, for the treatment of newly diagno ...

Core Insights - Candel Therapeutics announced positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, showing a statistically significant 30% reduction in disease recurrence compared to placebo when combined with standard-of-care radiation therapy [1][10] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to combat cancer [11] - 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 [11] Clinical Development - CAN-2409 (aglatimagene besadenovec) is designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumors, inducing a systemic immune response against cancer [8] - The investigational therapy has shown encouraging results in monotherapy and combination settings with standard treatments, with over 1,000 patients dosed and a favorable tolerability profile [9][10] - Candel is also evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) [10] Regulatory Status - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including PDAC and stage III/IV NSCLC, and has been granted Orphan Drug Designation for PDAC [10] Upcoming Events - Candel will host a webcast and conference call on June 3, 2025, to discuss the phase 3 clinical results and insights from leading prostate cancer specialists [1][5]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

NEEDHAM, Mass., May 22, 2025 (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 results from the Company’s positive phase 3 clinical trial of aglatimagene besadenovec (CAN-2409) in patients with intermediate-to-high-risk localized prostate cancer will be presented at the 2025 American Society of Clinical Oncology (ASCO) ...

Here are three stocks with buy rank and strong momentum characteristics for investors to consider today, May 19th:Candel Therapeutics, Inc. (CADL) : This clinical stage biopharmaceutical company has a Zacks Rank #1 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 17.9% over the last 60 days.Candel’s shares gained 34.4% over the last six months compared with the S&P 500’s advance of 0.7%. The company possesses a Momentum Score  of B.Horace Mann Educators Corporation (HMN) : ...

Group 1 - Candel Therapeutics, Inc. (CADL) closed at $5.11, with an 11.8% gain over the past four weeks, and a mean price target of $21 suggests a 311% upside potential [1] - The average price targets range from a low of $15 to a high of $25, with a standard deviation of $4.90, indicating a variability in estimates; the lowest estimate suggests a 193.5% increase, while the highest indicates a 389.2% upside [2] - Analysts show strong agreement on CADL's ability to report better earnings than previously predicted, which supports the view of potential upside [4][11] Group 2 - Over the last 30 days, the Zacks Consensus Estimate for CADL's current year earnings has increased by 17.5%, with one estimate moving higher and no negative revisions [12] - CADL holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential for upside in the near term [13]

Summary of Candel Therapeutics Conference Call Company Overview - Candel Therapeutics (CADL) is a clinical-stage biotech company focused on developing viral immunotherapy for difficult-to-treat cancers, utilizing two main platforms: HSV and adenoviral [1] Key Assets and Development Pipeline - The most advanced asset is CAN2409, an adenoviral platform targeting prostate cancer, with positive Phase 3 data recently unveiled and a BLA submission expected by the end of 2026 [2] - CAN2409 is also in development for non-small cell lung cancer (NSCLC) and pancreatic cancer, with fast track designation for all indications [3] - Another asset, CAN310, is a classical oncolytic virus in development for recurrent high-grade glioma [3] Clinical Data and Efficacy - CAN2409 has been administered to over 1,000 patients and shows synergy with radiation therapy, particularly in prostate cancer [4][5] - In NSCLC, a significant reduction of nearly 50% in tumor volume was observed in treated patients [6] - In recurrent high-grade glioma, median overall survival of at least 12 months was achieved with a single injection, compared to a median survival of 6-9 months in untreated patients [7] Discovery Platform - The Enlighten platform utilizes AI for data mining to design viral immunotherapies, aiming to combine with checkpoint inhibitors or cellular therapies for challenging cancers [7] Prostate Cancer Opportunity - Prostate cancer represents a multi-billion dollar opportunity due to the high prevalence and unmet medical need, especially in localized cases [11] - The trial included 745 patients, showing a 30% reduction in disease recurrence or death compared to placebo [14] - Significant effects on PSA levels, a key biomarker for recurrence, were noted, with a higher percentage of patients achieving pathological complete response [15] Safety and Tolerability - CAN2409 demonstrated a favorable safety profile, comparable to a prostate biopsy, with good tolerability among patients [15] Future Plans and Financials - Candel is ramping up CMC activities in preparation for commercial launch and is engaging with KOLs and medical affairs [16] - The company reported cash and cash equivalents of $92 million as of December, sufficient to support BLA submission in 2026 [22] Additional Insights - The pancreatic cancer trial indicated a significant improvement in median overall survival, with ongoing plans for a larger Phase 2 trial [17] - In lung cancer, adding CAN2409 to treatment for patients not responding to checkpoint inhibitors resulted in a median overall survival of 21 months, doubling expectations [20] Leadership and Achievements - The leadership team has extensive experience in drug development, and the company has exceeded its previous clinical milestones [21] Regulatory Engagement - Continuous discussions with the FDA regarding the BLA submission process are ongoing, focusing on CMC manufacturing and clinical package preparation [23][24]

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 March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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. E ...

Exhibit 99.1 Candel Therapeutics Reports First Quarter 2025 Financial Results and Recent Corporate Highlights Dr. Tak continued, "CAN-2409, Candel's most advanced multimodal biological immunotherapy candidate, continues to demonstrate meaningful overall survival benefits in patients with advanced NSCLC, non-responsive to immune checkpoint inhibitors, as well as in patients with borderline resectable PDAC. The totality of data showing notable extension of survival based on both phase 2a clinical trials in NS ...