Core Insights - Candel Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational adenovirus immunotherapy candidate, CAN-2409, aimed at treating newly diagnosed localized prostate cancer in patients with intermediate-to-high risk [1][3] - The RMAT designation was based on positive results from a phase III study that demonstrated the safety and efficacy of CAN-2409 in combination with a prodrug and standard of care radiation therapy [2][6] - Following the announcement, Candel's shares increased by 6.1%, although the stock has seen a year-to-date decline of 31.6%, contrasting with the industry's decline of 4.9% [3][4] Company Developments - The phase III study met its primary endpoint, showing statistically significant improvement in disease-free survival for patients receiving the combination therapy compared to standard of care alone [6] - Treatment with CAN-2409 was well tolerated, with no new safety signals identified, leading the company to plan a Biologics License Application (BLA) submission by the end of 2026 [7] - Candel is also exploring CAN-2409 in mid-stage studies for pancreatic and non-small cell lung cancer indications, in addition to its focus on prostate cancer [8] Market Position - Candel currently holds a Zacks Rank of 2 (Buy), indicating a favorable outlook within the biotech sector [9] - Other biotech stocks with a similar ranking include Lexicon Pharmaceuticals, Chemomab Therapeutics, and Amarin, each also carrying a Zacks Rank of 2 [9]

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 ...

Core Viewpoint - Candel Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its lead candidate CAN-2409, aimed at treating newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease, highlighting the potential of this therapy to address significant unmet medical needs [1][5][9] Group 1: FDA Designation and Implications - The RMAT designation is designed to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases, providing opportunities for intensive FDA guidance and support [2] - This designation allows for mechanisms that can speed up the Biologics License Application (BLA) review and approval process, including rolling review and priority review [2] Group 2: Clinical Trial Results - Positive data from a phase 3 randomized, placebo-controlled trial showed that CAN-2409 plus valacyclovir, combined with standard of care external beam radiation therapy, met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival (DFS) [3][4] - The trial indicated a 30% reduction in the risk of prostate cancer recurrence or death (HR 0.70; p=0.0155) for patients receiving CAN-2409 compared to placebo, with a 38% risk reduction in prostate-specific DFS (HR 0.62; p=0.0046) [4] - The treatment also resulted in a significant increase in patients achieving a prostate-specific antigen (PSA) nadir of <0.2 ng/ml (67.1% vs. 58.6%; p=0.0164) and an 80.4% pathological complete response in post-treatment biopsies [4] Group 3: Future Plans and Expectations - The company anticipates submitting the BLA for CAN-2409 by the end of 2026, aiming to introduce a new treatment option for early-stage prostate cancer, a field that has seen minimal innovation in the past two decades [6] - The RMAT designation is expected to facilitate the BLA filing process, bringing the company closer to achieving its objective of providing a new treatment option [6] Group 4: About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumors, inducing a CD8+ T cell-mediated immune response against cancer cells [7][8] - The therapy has shown encouraging activity in combination with standard treatments and has been dosed in over 1,000 patients with a favorable tolerability profile [8][9]

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, ...

Core Insights - Candel Therapeutics announced positive results from its phase 3 clinical trial of CAN-2409 for localized prostate cancer, which will be presented at the 2025 ASCO Annual Meeting [1][2][4] Clinical Trial Results - The phase 3 trial met its primary endpoint, showing a statistically significant improvement in disease-free survival (DFS) with a p-value of 0.0155 and a 30% reduction in the risk of recurrence or death (HR 0.7) for patients receiving CAN-2409 compared to placebo [2][4] - The trial included 496 patients receiving CAN-2409 and 249 patients receiving placebo, marking the first multicenter, randomized phase 3 trial in over 20 years to meet both primary and secondary endpoints in localized prostate cancer [2][3] Clinical Significance - The improvement in DFS is considered clinically meaningful, with tissue analysis indicating a higher rate of pathological clinical response in patients treated with CAN-2409 [3] - Approximately 30% of patients with intermediate-to-high-risk localized prostate cancer experience disease recurrence after standard treatments, highlighting the unmet need for effective therapies [3][10] Safety and Tolerability - CAN-2409 was generally well tolerated, with a low incidence of treatment-related serious adverse events (1.7% for CAN-2409 plus standard care vs. 2.2% for placebo plus standard care) [10] - Common adverse events included flu-like symptoms, fever, and chills, which were mostly mild to moderate [10] Future Developments - Candel plans to submit a Biologics License Application (BLA) for CAN-2409 in the fourth quarter of 2026, aiming to provide better treatment options for patients [3][10] - The company is also evaluating CAN-2409 in other cancers, including non-small cell lung cancer and pancreatic adenocarcinoma, and has received Fast Track Designation from the FDA for its use in pancreatic cancer [10][11]

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]

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