Candel Therapeutics, Inc. Stock Price, News & Analysis

Candel Therapeutics (Nasdaq: CADL) has received European Medicines Agency (EMA) Orphan Designation for its CAN-2409 treatment for pancreatic cancer. This adds to existing FDA Orphan Drug and Fast Track Designations received in 2024 and 2023.

The company's phase 2a clinical trial demonstrated remarkable results, with median overall survival of 31.4 months in the CAN-2409 plus standard of care arm versus 12.5 months in the control arm. Notably, three of seven treated patients were still alive at data cut-off with survival of 66.0, 63.6, and 35.8 months.

CAN-2409 is an investigational immunotherapy that delivers the HSV-tk gene to tumor cells, potentially inducing systemic immune responses against multiple therapy-resistant solid tumors. The EMA designation provides benefits including reduced fees, protocol assistance, and up to 10 years of market exclusivity if approved.

Candel Therapeutics (Nasdaq: CADL), a clinical-stage biopharmaceutical company, has expanded its presence in Russell indexes following the 2025 Russell US Indexes reconstitution. The company was added to multiple value-oriented indexes including the Russell 2500 Value®, Russell Small Cap Value®, Russell 2000 Value®, Russell Microcap Value®, and Russell 3000E® Value Index, while maintaining its position in the Russell 3000® Index.

This expansion comes at a crucial time as Candel prepares for a potential Biologics License Application for CAN-2409 in intermediate-to-high-risk localized prostate cancer. The company continues to advance its multimodal immunotherapy platform across various solid tumors, focusing on developing biological immunotherapies for cancer treatment.

Candel Therapeutics (Nasdaq: CADL) has announced a $15 million registered direct offering of common stock, selling approximately 3.2 million shares at $4.67 per share to select accredited investors, including healthcare-focused institutional investors and company insiders. The offering is expected to close on June 25, 2025.

The proceeds will support pre-commercialization and launch readiness activities for CAN-2409 in prostate cancer, with a planned Biologics License Application submission in Q4 2026. The participation of existing investors, executives, and board members demonstrates confidence in Candel's approach to treating intractable tumors.

Candel Therapeutics (NASDAQ: CADL) has appointed Charles Schoch as permanent Chief Financial Officer, following his successful tenure as interim CFO since January 2024. Schoch, who joined Candel in 2021, previously served as VP of Finance and Corporate Controller before being promoted to Senior VP in January 2025. During his interim CFO role, he successfully led an $86 million capital raise following positive Phase 3 trial results for CAN-2409 in prostate cancer. His experience includes roles at Corbus Pharmaceuticals, PwC's Health Industry practice, and Third Rock Venture portfolio companies. The appointment comes as Candel prepares for its Biologics License Application submission for CAN-2409 in localized prostate cancer.

Candel Therapeutics (NASDAQ: CADL) has appointed Dr. Maha Radhakrishnan to its Board of Directors effective June 4, 2025. Dr. Radhakrishnan brings over 20 years of experience in product development and commercialization within major biotechnology and pharmaceutical companies. Currently serving as Executive Partner at Sofinnova Investments, she previously held key positions at Biogen, Sanofi, Bioverativ, Bristol-Myers Squibb, UnitedHealth Group, and Cephalon. Her appointment comes at a crucial time as Candel prepares for its Biologics License Application (BLA) submission for CAN-2409 in intermediate-to-high-risk prostate cancer, expected in Q4 2026. The company aims to strengthen its leadership as it advances its late-stage oncology programs toward potential approval and commercial development.

Candel Therapeutics (NASDAQ: CADL) has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for CAN-2409, its biological immunotherapy candidate for treating newly diagnosed localized prostate cancer. The designation, based on positive phase 3 trial results, could expedite development and review processes. The trial met its primary endpoint with significant improvements: - 30% reduction in prostate cancer recurrence or death risk - 38% improvement in prostate-specific disease-free survival - 80.4% pathological complete response vs 63.6% in control - 67.1% of patients achieved PSA nadir <0.2 ng/ml vs 58.6% in placebo The company plans to submit its Biologics License Application (BLA) by the end of 2026. CAN-2409 demonstrated a consistent safety profile with no new safety signals identified.

Candel Therapeutics (NASDAQ: CADL) has announced a webcast and conference call scheduled for June 3, 2025, at 1:00PM ET to discuss positive Phase 3 clinical results for their CAN-2409 treatment in localized, intermediate-to-high risk prostate cancer. The results showed a statistically significant 30% reduction in disease recurrence compared to placebo when combined with standard-of-care radiation therapy.

The call will feature insights from principal investigators Dr. John E. Sylvester and Dr. Ronald F. Tutrone, Jr., following Dr. Theodore DeWeese's oral presentation at the 2025 ASCO Annual Meeting. Both featured specialists bring extensive experience in prostate cancer treatment and research, with over two decades of expertise in their respective fields.

Candel Therapeutics (NASDAQ: CADL) announced positive Phase 3 results for CAN-2409 in localized prostate cancer treatment, to be presented at ASCO 2025. The trial met its primary and secondary endpoints, showing a 30% reduction in cancer recurrence or death risk. CAN-2409, combined with valacyclovir and standard radiation therapy, demonstrated statistically significant improvement in disease-free survival (p=0.0155) compared to placebo. Key findings include: 80.4% pathological complete responses vs 63.6% in control, significant increase in PSA nadir achievement (67.1% vs 58.6%), and a favorable safety profile with low treatment-related adverse events (1.7%). This marks the first successful Phase 3 trial in localized prostate cancer in over 20 years, with Candel planning to submit a Biologics License Application in Q4 2026.

Candel Therapeutics (NASDAQ: CADL) reported Q1 2025 financial results and significant clinical progress. The company's lead candidate CAN-2409 showed positive Phase 3 results in prostate cancer, with BLA submission planned for Q4 2026. Notable achievements include: • Promising survival data in pancreatic cancer (PDAC), with median overall survival of 31.4 months vs 12.5 months in control group • Strong results in non-small cell lung cancer (NSCLC), with 24.5-month median overall survival in ICI-inadequate responders • Favorable Phase 1b results in high-grade glioma Financial highlights: Q1 2025 showed net income of $7.4 million compared to $8.2 million loss in Q1 2024. Cash position of $92.2 million expected to fund operations into Q1 2027. R&D expenses were $4.0 million, while G&A expenses reached $4.1 million.