Financial Position - Candel Therapeutics reported a cash position of approximately $103 million as of December 31, 2024, expected to fund operations into Q1 2027[4]. - Management emphasizes the importance of cash runway and expenditures in future planning[19]. Clinical Trials and Results - Positive topline data from the phase 3 trial of CAN-2409 in prostate cancer showed a 30% reduction in the risk of recurrence or death compared to the control group, with a p-value of 0.0155[6]. - In the phase 2a trial for borderline resectable pancreatic cancer, CAN-2409 demonstrated a median overall survival of 28.8 months, compared to 12.5 months in the control group[7]. - The survival rate at 24 months for CAN-2409-treated patients in pancreatic cancer was 71.4%, versus 16.7% in the control group[7]. - CAN-2409 in non-small cell lung cancer (NSCLC) showed a median overall survival of 20.6 months, significantly higher than the published results of less than 12 months with standard chemotherapy[7]. - CAN-3110 is currently in a phase 1b trial for recurrent high-grade glioma, with overall survival data expected in Q4 2025[13]. - The company anticipates reporting updated overall survival data for CAN-2409 in pancreatic cancer and NSCLC in Q1 2025[9]. Development Programs - Candel is preparing for a Biologics License Application (BLA) submission for CAN-2409 in prostate cancer, expected in Q4 2026[4]. - Candel Therapeutics is advancing development programs for CAN-2409 and CAN-3110, targeting improved overall survival in patients with various cancers[19]. - The enLIGHTEN™ Discovery Platform aims to identify new candidates for difficult-to-treat solid tumors[19]. - Candel's enLIGHTEN™ Discovery Platform has generated two novel experimental assets, focusing on multimodal immunotherapies for solid tumors[5]. Regulatory Designations - The FDA has granted Fast Track Designation for both CAN-2409 and CAN-3110 in their respective indications, facilitating expedited development[7]. - The company is focused on obtaining orphan drug designation and fast track designation to enhance therapeutic benefits[19]. Risks and Challenges - The company acknowledges risks related to the timing and advancement of development programs and regulatory approvals[20].

Core Insights - Candel Therapeutics, Inc. reported a transformational year in 2024, achieving significant clinical milestones and preparing for regulatory submissions in 2025 [2][4] - The company is focused on advancing its lead product candidate, CAN-2409, for prostate cancer and exploring its efficacy in other indications such as pancreatic cancer and non-small cell lung cancer [2][4][14] Clinical Developments - Positive topline phase 3 data for CAN-2409 in localized prostate cancer demonstrated a 30% reduction in the risk of recurrence or death compared to the control group [6][8] - CAN-2409 showed a median overall survival of 31.4 months in patients with borderline resectable pancreatic cancer, significantly higher than the 12.5 months in the control group [5][14] - The company is preparing to submit a Biologics License Application (BLA) for CAN-2409 in prostate cancer by Q4 2026 [4][11] Financial Performance - Research and development expenses decreased to $4.8 million in Q4 2024 from $7.3 million in Q4 2023, and for the full year, expenses were $19.3 million compared to $24.5 million in 2023 [9] - General and administrative expenses slightly increased to $3.3 million in Q4 2024 from $3.1 million in Q4 2023, with full-year expenses at $14.1 million compared to $13.9 million in 2023 [10] - The net loss for Q4 2024 was $14.1 million, up from $11.1 million in Q4 2023, with a full-year net loss of $55.2 million compared to $37.9 million in 2023 [11] Cash Position - As of December 31, 2024, cash and cash equivalents were $102.7 million, a significant increase from $35.4 million at the end of 2023, providing a runway into Q1 2027 [12][26] Corporate Updates - Candel completed a public offering in December 2024, raising approximately $85.9 million through the sale of 12 million shares at $6.00 each [4][10] - The company is also advancing its enLIGHTEN Discovery Platform, which aims to develop new multimodal biological immunotherapies for solid tumors [17][18]

Core Insights - Candel Therapeutics Inc's investigational medicine CAN-2409 shows promising results in a phase 2 trial for borderline resectable pancreatic cancer, with a median overall survival of 31.4 months compared to 12.5 months in the control group [2][7] - The treatment has demonstrated a significant breakthrough potential for patients with typically poor prognoses, as standard survival rates for this cancer type range from 6 to 12 months [3][9] - The company aims to confirm these results in a larger randomized controlled clinical trial, with hopes for FDA approval and potential testing in other stages of pancreatic cancer [10][11] Treatment Details - The phase 2 trial involved patients with borderline resectable pancreatic cancer, where tumors invade blood vessels, making surgery unfeasible initially [5] - All patients received standard chemotherapy followed by chemoradiation, with the active treatment group receiving 2 to 3 doses of CAN-2409 [6][10] - Notably, three out of seven patients in the treatment group remained alive after prolonged follow-up, with two patients exceeding five years of survival [2][8] Future Prospects - The company has received fast track designation and orphan drug designation from the FDA, which will facilitate the development process [11] - There is a strong motivation within the company to improve patient outcomes and create value for shareholders through advancements in oncology [12][13]

Core Insights - Candel Therapeutics, Inc. (NASDAQ: CADL) has experienced significant volatility since December, with a maintained "Buy" sentiment due to positive developments in the company [1] Company Overview - Candel Therapeutics is focused on the biotech sector, particularly in the analysis of clinical trials and the science behind its business operations [1] Investment Sentiment - The article emphasizes the importance of due diligence in biotech investments, highlighting the potential pitfalls that investors may encounter [1]

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Core Insights - Candel Therapeutics announced final overall survival data from a phase 2 clinical trial of CAN-2409 combined with standard of care for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) [1][2] Group 1: Clinical Trial Results - The trial showed a significant improvement in estimated median overall survival of 31.4 months for the CAN-2409 group compared to 12.5 months for the control group [5][6] - Three out of seven patients treated with CAN-2409 were alive at 66.0, 63.6, and 35.8 months post-enrollment, with survival from diagnosis at 73.5, 68.8, and 41.3 months respectively [6][5] - The safety profile of CAN-2409 was generally favorable, with no dose-limiting toxicities reported [5][10] Group 2: Mechanism and Designation - CAN-2409 is a first-in-class multimodal immunotherapy designed for in situ vaccination against tumors, potentially improving outcomes in difficult-to-treat cancers like PDAC [3][8] - The therapy has received Fast Track Designation and Orphan Drug Designation from the FDA for the treatment of PDAC [5][7] Group 3: Future Directions - Based on the promising findings, the company plans to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in PDAC [7][9] - Candel is also evaluating CAN-2409 in other cancers, including non-small cell lung cancer and localized prostate cancer, where it has shown statistically significant improvement in disease-free survival [9][10]

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Core Message - Candel Therapeutics highlights recent successes in its viral immunotherapy portfolio, particularly with CAN-2409 and CAN-3110, and provides updates on its cash position and upcoming 2025 milestones [1][2] CAN-2409 - Prostate Cancer - Positive topline phase 3 data for CAN-2409 in intermediate-to-high risk localized prostate cancer showed a 30% reduction in the risk of recurrence or death compared to placebo (p=0.0155) [3] - 80.4% pathological complete responses in 2-year post-treatment biopsies after CAN-2409 administration compared to 63.6% in the control arm (p=0.0015) [3] - The study was conducted under a Special Protocol Assessment (SPA) with FDA agreement, indicating potential for regulatory approval [3] CAN-2409 - Pancreatic Cancer - Updated survival data from phase 2a trial showed median overall survival (mOS) of 28.8 months with CAN-2409 versus 12.5 months in the control group [5] - At 24 months, survival rate was 71.4% in CAN-2409-treated patients versus 16.7% in the control group [5] - At 36 months, estimated survival was 47.6% in the CAN-2409 group versus 16.7% in the control group [5] CAN-2409 - Non-Small Cell Lung Cancer - Phase 2a trial data showed mOS of 20.6 months in patients with progressive disease despite immune checkpoint inhibitor (ICI) treatment, compared to less than 12 months with standard of care (SoC) docetaxel-based chemotherapy [5] - CAN-2409 exhibited a favorable safety and tolerability profile in NSCLC [5] CAN-3110 - Recurrent High-Grade Glioma - Phase 1b trial data showed improved survival compared to historical controls, with 3 out of 6 patients still alive after more than one year (12.2, 13.0, and 18.7 months) [5] - CAN-3110 received Orphan Drug Designation and Fast Track Designation from the FDA [5] CAN-3110 - Melanoma - Preclinical results showed dose-dependent inhibition of tumor growth, with regression observed in 3 out of 8 tumors treated with a high dose of CAN-3110 [5] - CAN-3110 exhibited potent, tumor-specific cytotoxicity in melanoma cell lines [5] enLIGHTEN™ Discovery Platform - Presented data on a new multimodal viral therapeutic candidate encoding IL-12 and IL-15, showing significant tumor growth inhibition and regression in preclinical models [5] - Developed a first-in-class multimodal immunotherapy candidate for the induction of tertiary lymphoid structures (TLS) [5] Cash Position - Cash and cash equivalents as of December 31, 2024, were $102.9 million, compared to $35.4 million as of December 31, 2023 [6] - The company expects its cash to support operations into Q1 2027, including BLA submission for CAN-2409 in prostate cancer [6] 2025 Anticipated Milestones - Updated overall survival data from phase 2a clinical trials in pancreatic cancer and NSCLC expected in Q1 2025 [5][10] - BLA submission for CAN-2409 in prostate cancer on track for Q4 2026 [10] - Overall survival data from phase 1b trial of CAN-3110 in rHGG expected in Q4 2025 [10] About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene to induce a systemic immune response against tumors [7] - More than 1,000 patients have been dosed with CAN-2409, showing a favorable tolerability profile [7] About CAN-3110 - CAN-3110 is a first-in-class, replication-competent HSV-1 oncolytic viral immunotherapy candidate with dual activity for oncolysis and immune activation [9] - It has received FDA Fast Track and Orphan Drug Designations for the treatment of rHGG [9] About enLIGHTEN™ Discovery Platform - The platform leverages human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors [11] - It has been used to develop candidates like Alpha 201-macro-1 and a TLS inducer for solid tumors [11] About Candel Therapeutics - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies for cancer [12] - The company has two clinical-stage platforms: adenovirus-based (CAN-2409) and HSV-based (CAN-3110) [12]

Clinical Trials and Pipeline Advancements - CAN-2409 combined with valacyclovir extended median survival to 20.6 months in NSCLC patients with disease progression despite ICI therapy, showing good safety and immune system activation [1] - The company is advancing its pipeline with ongoing trials for obesity treatments and other metabolic disorders [2] - QUILT 3.032 study showed a 71% complete response rate in BCG-unresponsive NMIBC, supporting submissions to the European Medicines Agency in Q4 2024 [3] - Certepetide, designed to enhance anti-cancer agent delivery, completed patient enrollment with results anticipated in 2025 [4] - The company plans to conduct an interim data analysis in Q1 2025 and submit findings to the FDA to discuss next steps in the clinical development program [5] - MAVERIC-2 trial will explore CardiolRx's effects in patients who stopped using IL-1 blockers, with an expected readout before the Phase 3 MAVERIC-3 trial begins [8] - The company is advancing clinical trials for VLS-01 and EMP-01 programs, with data readouts expected in the new year [6] - The Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis was expanded to prestigious US Medical Centers [12] - VLS-01, a buccal film formulation of DMT for treatment-resistant depression, is set to progress through its Phase 2 study with topline results expected around the end of the year [13] - ANKTIVA's clinical trials are expanding in NMIBC, prostate cancer, and NSCLC, with a broader market launch targeted for 2025 [14][15] - NV-387 is advancing into Phase 2 clinical trials for MPox, RSV, and influenza [16][31][32] - The ASCEND trial targeting metastatic pancreatic ductal adenocarcinoma is expected to deliver interim data in January [18] - A pediatric clinical trial for Anaphylm commenced in December 2024, following positive FDA feedback [19] - The Phase 2 trial of OK-101 for dry eye disease showed promising reductions in ocular pain and inflammation [21] - CAN-2409's Phase 3 trial in intermediate-to-high-risk localized prostate cancer met its primary endpoint, showing a statistically significant improvement in disease-free survival [25] - The SKNJCT-003 clinical study is evaluating Doxorubicin-containing microneedle array in treating BCC, with over 25% of the 60 patients already randomized [26] - VK2809 demonstrated significant reductions in liver fat, NASH resolution, and fibrosis improvement in the Phase 2b VOYAGE study [27] - EMP-01, an oral formulation of R-MDMA, is set to initiate a Phase 2 trial for social anxiety disorder, with results anticipated by the end of 2025 [30] - The Phase 2 CALLIPER trial for progressive multiple sclerosis is expected to deliver top-line data in April 2025 [45] - The Phase 2 ARCHER trial in acute myocarditis completed enrollment in September 2024, with results expected in early 2025 [39] Strategic Collaborations and Regulatory Submissions - The company entered a collaboration agreement with Swanielle to explore expanding the Phase 2 study into the Asia-Pacific region [11] - ANKTIVA's J-code will be effective in January 2025, facilitating wider patient access [15] - The company plans to submit ANKTIVA for approval in the United Kingdom and the European Union [15] - A New Drug Application for Anaphylm sublingual film will be submitted to the FDA, aiming to advance the first orally delivered epinephrine treatment for severe allergic reactions [35] - The company will expand the availability of Libervant buccal film, which has received FDA Orphan Drug Exclusivity for treating seizure clusters in pediatric patients [36] Key Therapeutic Areas and Innovations - Key trials include cancer immunotherapies, treatments for neurological conditions like multiple sclerosis and Alzheimer's, and novel approaches to metabolic diseases and chronic pain [9] - The company is advancing groundbreaking research into Alzheimer's disease, following the dosing of the first patient with moderate Alzheimer's [12] - NV-387's Phase 2 trial in MPox aims to address the high fatality rate of MPox Clade 1/1b, for which no effective treatments are currently available [31] - Vidofludimus calcium is being investigated for its neuroprotective and anti-inflammatory properties in progressive multiple sclerosis [33] - The CENDIFOX trial is evaluating the combination of certepetide with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers [34] - CardiolRx is advancing into pivotal late-stage trials for recurrent pericarditis, with key milestones anticipated in 2025 [37] - The Phase 2 trial of OK-101 for neuropathic corneal pain aims to address a condition with no FDA-approved treatments [44]

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 ...