Core Viewpoint - Candel Therapeutics, Inc. has agreed to sell approximately 3.2 million shares of common stock at a price of $4.67 per share, aiming to raise about $15.0 million to support its cancer treatment initiatives and corporate purposes [1][3]. Group 1: Offering Details - The offering is expected to close on June 25, 2025, subject to customary closing conditions [1]. - The investors include existing healthcare-focused institutional investors, executive officers, and members of the Company's Board of Directors [2]. - The shares are being offered under a shelf registration statement previously filed with the SEC [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for pre-commercialization and launch readiness activities for CAN-2409 in prostate cancer, as well as for general corporate purposes [3]. - The Company is preparing for the submission of a Biologics License Application for CAN-2409, expected in the fourth quarter of 2026 [3]. Group 3: Company Overview - Candel Therapeutics is focused on developing multimodal biological immunotherapies to combat cancer, with two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus [6]. - CAN-2409 is the lead product candidate from the adenovirus platform, which has shown promising results in clinical trials for various cancers [7]. - The Company has received multiple designations from the FDA for CAN-2409, including Fast Track and Orphan Drug Designations [7].

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Core Viewpoint - Candel Therapeutics has appointed Charles Schoch as the permanent Chief Financial Officer after his successful tenure as interim CFO, demonstrating strong financial leadership and guiding the company through significant operational and financial milestones [1][2]. Company Leadership - Charles Schoch has been with Candel since November 2021, serving in various financial roles, including VP of Finance and Corporate Controller, before becoming interim CFO in January 2024 [2][3]. - Under Schoch's leadership, the company raised approximately $86 million following positive phase 3 clinical trial results for CAN-2409 in localized prostate cancer [2]. Financial Management - Schoch has established strong investment banking relationships and has effectively managed capital during a complex market environment, supporting Candel's strategic priorities [2][4]. - The finance function under Schoch oversees financial close processes, internal controls, SEC reporting, financial planning, procurement, payroll, and treasury operations [2]. Clinical Development - Candel is focused on developing multimodal biological immunotherapies, with CAN-2409 as the lead product candidate from its adenovirus platform [5]. - The company has completed successful phase 2a clinical trials for CAN-2409 in non-small cell lung cancer and pancreatic ductal adenocarcinoma, and a pivotal phase 3 trial in localized prostate cancer [6][7]. Regulatory Designations - CAN-2409 has received Fast Track Designation from the FDA for multiple cancer treatments and has also been granted Regenerative Medicine Advanced Therapy Designation for localized prostate cancer [6][7]. - The company is preparing for a Biologics License Application submission for CAN-2409 in localized prostate cancer [2]. Future Outlook - Schoch expressed optimism about Candel's financial foundation and disciplined capital allocation, focusing on sustainable growth and advancing the clinical pipeline [4].

Company Overview - Proactive is a publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team operates from key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - The company specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive delivers news and insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for being a forward-looking and enthusiastic adopter of technology, utilizing decades of expertise and experience among its content creators [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - Candel Therapeutics has appointed Dr. Maha Radhakrishnan to its Board of Directors, effective June 4, 2025, to enhance its strategic capabilities as it moves towards Biologics License Application (BLA) submission and commercial development [1][2][4] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies aimed at treating cancer [5] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [5] Product Development - Candel's lead product candidate, CAN-2409, is being developed for intermediate-to-high-risk prostate cancer, with BLA submission anticipated in Q4 2026 [2][4] - Recent successful phase 2a clinical trials of CAN-2409 were completed in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [6] - CAN-2409 has received Fast Track Designation from the FDA for treating PDAC and stage III/IV NSCLC in specific patient populations [6] Leadership Experience - Dr. Radhakrishnan brings over 20 years of experience in product development and commercialization from major biotechnology and pharmaceutical companies [3] - Her previous roles include Senior Vice President and Chief Medical Officer at Biogen and Global Head of Medical at Sanofi [3] Future Outlook - The company aims to leverage Dr. Radhakrishnan's expertise as it prepares for the BLA submission and advances its innovative immunotherapy candidates [2][4]

Summary of Candel Therapeutics Conference Call Company Overview - Candel Therapeutics is focused on developing viral immunotherapies for difficult-to-treat cancers, with a lead compound named CAN2409, which is an adenovirus engineered to deliver a gene encoding thymidine kinase into tumor cells [2][6] Core Points and Arguments Lead Product: CAN2409 - CAN2409 is designed to induce immunogenic cell death, allowing the immune system to recognize tumor-specific antigens [6][7] - The compound has been administered to over 1,000 patients, demonstrating safety and tolerability [8] - Fast track designations have been received for prostate cancer, pancreatic cancer, and non-small cell lung cancer, along with orphan drug designation for pancreatic cancer [8] Clinical Trial Results - A pivotal phase three trial showed that CAN2409 plus valacyclovir improved disease-free survival by 30% compared to placebo [16][42] - The trial involved 745 patients, focusing on early localized non-metastatic prostate cancer, a significant area of unmet need [17][12] - The treatment demonstrated a 38% improvement in prostate cancer-specific disease-free survival [30][42] - A high percentage (over 80%) of patients achieved a pathological complete response in a two-year biopsy [39][42] Safety and Tolerability - The treatment was well tolerated, with mild flu-like symptoms reported, comparable to COVID-19 vaccination [25][26] - There were trends towards lower serious adverse events in the treatment group compared to placebo [26] Future Plans and Market Strategy - Candel Therapeutics is preparing for a Biologics License Application (BLA) submission expected in Q4 of the following year [42] - The company is working with external partners for manufacturing and market research to ensure a successful launch [45][46] - Pricing strategy is being developed to ensure broad patient access, with benchmarks for advanced disease treatments ranging from $130,000 to $260,000 [50] Other Important Content Additional Indications - Encouraging data were presented for CAN2409 in borderline resectable pancreatic cancer, showing a median overall survival of 31.4 months compared to 12.5 months in the control group [54] - Data for therapy-resistant non-small cell lung cancer indicated a median overall survival of 25.4 months, which is better than existing treatments [59] Research and Development Pipeline - Candel Therapeutics is also developing CAM310, a next-generation HSV oncolytic virus for recurrent glioblastoma, with promising results expected [61] Team and Governance - The company has a senior team with extensive experience in drug discovery and development, supported by a research advisory board of notable experts in oncology [62] This summary encapsulates the key points from the conference call, highlighting the company's focus on innovative cancer therapies, promising clinical results, and strategic plans for market entry.

Shares of Candel Therapeutics, Inc. (CADL) have gained 3.2% over the past four weeks to close the last trading session at $5.45, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $21 indicates a potential upside of 285.3%.The average comprises four short-term price targets ranging from a low of $15 to a high of $25, with a standard deviation of $4.90. While the lowest estimate ind ...

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]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]

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]