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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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 ...

Core Insights - Candel Therapeutics, Inc. reported strong clinical evidence supporting its pipeline of pan solid tumor immunotherapies, with a primary focus on CAN-2409 for prostate cancer, which is expected to address significant unmet medical needs [2][4] Financial Results - Research and development expenses for Q1 2025 were $4.0 million, a slight decrease from $4.1 million in Q1 2024, primarily due to reduced employee-related expenses [8] - General and administrative expenses increased to $4.1 million in Q1 2025 from $3.8 million in Q1 2024, attributed to higher professional and consulting fees [9] - The company reported a net income of $7.4 million for Q1 2025, compared to a net loss of $8.2 million in Q1 2024, largely due to changes in the fair value of the company's warrant liability [10] - Cash and cash equivalents as of March 31, 2025, were $92.2 million, down from $102.7 million at the end of 2024, with expectations to fund operations into Q1 2027 [11] Clinical Developments - CAN-2409's phase 3 trial results for localized prostate cancer will be presented at the 2025 ASCO Annual Meeting, with a BLA submission anticipated in Q4 2026 [4][5] - In advanced non-small cell lung cancer (NSCLC), CAN-2409 demonstrated a median overall survival (mOS) of 24.5 months in patients inadequately responding to immune checkpoint inhibitors, significantly exceeding standard care outcomes [7] - For borderline resectable pancreatic adenocarcinoma (PDAC), CAN-2409 showed an mOS of 31.4 months compared to 12.5 months in the control group, indicating substantial survival benefits [7] Strategic Collaborations and Appointments - Candel entered a strategic collaboration with IDEA Pharma to enhance commercialization strategies for CAN-2409 [7] - Elizabeth M. Jaffee, M.D., an expert in cancer immunology, was appointed to the Research Advisory Board, strengthening the company's focus on pancreatic cancer [7] Product Overview - CAN-2409 is a multimodal biological immunotherapy designed to induce a systemic immune response against tumors, with potential applications across various solid tumors [12][18] - The FDA has granted Fast Track Designation for CAN-2409 in multiple indications, including localized prostate cancer and advanced NSCLC [13][18]