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Candel Therapeutics(CADL) - 2025 Q1 - Quarterly Results
2025-05-13 12:15
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 ...
Candel Therapeutics Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
Globenewswire· 2025-05-13 12:05
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]
Candel Therapeutics to Present at Upcoming Investor Conferences
Globenewswire· 2025-05-06 12:05
Core Insights - Candel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies for cancer treatment [3] - The company will present at two upcoming investor conferences, highlighting its commitment to engaging with investors [1][2] Company Overview - Candel Therapeutics specializes in off-the-shelf multimodal biological immunotherapies that aim to elicit individualized, systemic anti-tumor immune responses [3] - The company has two clinical stage platforms: one based on genetically modified adenovirus and the other on herpes simplex virus (HSV) gene constructs [3] - The lead product candidate from the adenovirus platform, CAN-2409, has completed successful phase 2a clinical trials in non-small cell lung cancer and borderline resectable pancreatic ductal adenocarcinoma, as well as a pivotal phase 3 trial in localized prostate cancer [3] - The lead product candidate from the HSV platform, CAN-3110, is currently in a phase 1b clinical trial for recurrent high-grade glioma [3] - Candel's enLIGHTEN™ Discovery Platform utilizes human biology and advanced analytics to develop new viral immunotherapies for solid tumors [3]
Candel Therapeutics Announces Oral Presentation of Positive Phase 3 CAN-2409 Results in Localized Prostate Cancer at ASCO 2025
Globenewswire· 2025-04-23 20:05
Core Viewpoint - Candel Therapeutics, Inc. announced that an abstract for an oral presentation regarding its phase 3 clinical trial of CAN-2409 in localized prostate cancer has been accepted for the 2025 ASCO Annual Meeting, highlighting the company's focus on developing immunotherapies for cancer treatment [1]. Group 1: Clinical Trial and Presentation Details - The oral presentation will feature data from the phase 3 clinical trial of CAN-2409, targeting patients with intermediate-to-high risk localized prostate cancer [1]. - The session is scheduled for June 3, 2025, at the ASCO Annual Meeting in Chicago, IL, with Dr. Theodore DeWeese as the presenter [8]. Group 2: Product Information - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene to tumors, inducing a systemic immune response against cancer cells [5]. - The therapy has shown promising results in previous trials, including a significant improvement in disease-free survival when combined with standard radiation therapy in localized prostate cancer [6]. Group 3: Clinical Development and Regulatory Designations - Candel's clinical development program for CAN-2409 includes positive phase 2a trials in non-small cell lung cancer and pancreatic ductal adenocarcinoma, as well as a successful phase 3 trial in localized prostate cancer [6][9]. - The FDA has granted Fast Track Designation for CAN-2409 for multiple cancer types, including localized prostate cancer and PDAC, indicating its potential therapeutic significance [9].
Candel Therapeutics reveals new data showing better outcomes for glioma patients using CAN-2409
Proactiveinvestors NA· 2025-04-01 13:46
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. She earned a Bachelo ...
Candel Therapeutics Announces Publication of Phase 1b Clinical Trial Data on the Combination of CAN-2409 and Nivolumab plus Standard of Care in Newly Diagnosed High-Grade Glioma Patients
Newsfilter· 2025-04-01 12:01
NEEDHAM, Mass., April 01, 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 the publication of a manuscript reporting the results of a phase 1b clinical trial exploring safety and tolerability of the combination of CAN- 2409 plus prodrug (valacyclovir) and nivolumab, in addition to standard of care (neurosurgery, radioth ...
Candel Therapeutics reports breakthrough data for late-stage lung cancer – ICYMI
Proactiveinvestors NA· 2025-03-29 13:19
Core Insights - Candel Therapeutics Inc has presented promising clinical data from a Phase 2a study of its immunotherapy candidate CAN-2409 for advanced non-small cell lung cancer, particularly in patients who have exhausted standard treatment options [1][2] - The study indicates that CAN-2409 may double the expected median overall survival for patients who have failed multiple lines of chemotherapy and immune checkpoint inhibitors [2][6] Patient Population - The study enrolled patients with advanced non-small cell lung cancer, primarily those with stage four metastatic disease and poor prognostic indicators, including low PD-L1 expression and a history of smoking [1][4][5] - 90% of participants had stage four metastatic disease and had previously failed all available treatments, indicating a very poor prognosis [4][5] Clinical Outcomes - The results showed that 37% of patients were still alive two years after treatment with CAN-2409, which is significantly longer than expected for this patient population [3][6] - Some patients have survived beyond three or four years, which is notable given their progressive metastatic lung cancer [3] Treatment Comparison - The standard of care for this patient population is docetaxel chemotherapy, which has a median overall survival of no more than 10.8 months [5] - CAN-2409 has shown potential to extend overall survival significantly beyond this benchmark, providing hope for patients with limited options [6][9] Future Steps - The company plans to conduct a larger, registration-enabling clinical trial to further validate these findings, aligning with key academic experts and the FDA [6][7] - The timeline for this next phase has not yet been announced, but the company is actively engaging with experts to expedite the process [7] Broader Implications - The application of CAN-2409 may extend beyond lung cancer, with indications of similar efficacy in pancreatic cancer, another challenging disease [8] - The treatment is generally well tolerated, with mild flu-like symptoms lasting less than 24 hours, and requires only two administrations to educate the patient's immune system to control the tumor [9]
Candel Therapeutics reports positive survival data for CAN-2409 in advanced lung cancer trial
Proactiveinvestors NA· 2025-03-26 20:21
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
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]
Bears are Losing Control Over Candel Therapeutics (CADL), Here's Why It's a 'Buy' Now
ZACKS· 2025-03-25 14:55
Core Viewpoint - Candel Therapeutics, Inc. (CADL) has experienced a 21% decline in stock price over the past four weeks, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, suggesting that selling pressure may be exhausting [2][4]. - This pattern forms when there is a small candle body with a long lower wick, indicating that the stock opened lower, made a new low, but closed near its opening price, reflecting buying interest [3][4]. - Hammer candles can appear on various timeframes and are utilized by both short-term and long-term investors [4]. Fundamental Analysis - Recent upward revisions in earnings estimates for CADL serve as a bullish indicator, correlating strongly with near-term stock price movements [6]. - The consensus EPS estimate for the current year has increased by 3.5% over the last 30 days, indicating analysts' optimism about the company's earnings potential [7]. - CADL holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [8].