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Candel Therapeutics Announces $15 million Registered Direct Offering of Common Stock
Globenewswire· 2025-06-24 13:05
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].
Candel Therapeutics Appoints Charles Schoch as Chief Financial Officer
Globenewswire· 2025-06-23 12:05
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].
Candel Therapeutics Reports Both Prolonged Median Overall Survival and Long Tail of Survival in Phase 2a Clinical Trial of CAN-2409 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Non-Responsive to Immune Checkpoint Inhibitor (ICI) Treatment
Globenewswire· 2025-03-26 20:05
Core Insights - Candel Therapeutics announced final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer (NSCLC) who inadequately responded to immune checkpoint inhibitor (ICI) treatment, showing a median overall survival (mOS) of 24.5 months in evaluable patients [1][5] - The study demonstrated a significant survival benefit compared to standard treatments, with 37% of patients with progressive disease alive two years after CAN-2409 administration [1][5] - The treatment showed improved mOS in non-squamous NSCLC patients, with a mOS of 25.4 months observed in this subgroup [2][5] Clinical Trial Results - The final analysis included 46 evaluable patients, with a median follow-up time of 32.4 months, revealing a long tail of survival [1][4] - Patients with progressive disease at baseline had a mOS of 21.5 months, significantly exceeding the 9.8-11.8 months reported for standard docetaxel chemotherapy [5][8] - A systemic immune response was observed in approximately two-thirds of patients, indicating an abscopal effect [5][8] Safety and Tolerability - CAN-2409 maintained a favorable safety and tolerability profile throughout the extended follow-up period, with no new safety signals identified [5][8] - Dropout rates during the trial were comparable to other clinical trials in similar populations, indicating the treatment's feasibility [4][6] Future Development - Based on positive findings, Candel plans to advance the development program for CAN-2409, including preparations for a potentially registrational clinical trial in NSCLC patients with non-squamous histology [7][10] - The FDA has granted Fast Track Designation for CAN-2409 in combination with ICI treatment for stage III/IV NSCLC patients resistant to first-line therapy [7][10] About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to induce a systemic immune response against tumors [8][9] - The treatment has shown encouraging activity in various solid tumors and has been well tolerated in over 1,000 patients [9][11]