Candel Therapeutics, Inc. Stock Price, News & Analysis

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.

Candel Therapeutics (NASDAQ: CADL), a clinical stage biopharmaceutical company developing biological immunotherapies for cancer treatment, has announced its participation in two major upcoming investor conferences:

1. Bank of America Securities 2025 Health Care Conference in Las Vegas: - Chief Scientific Officer Francesca Barone will present on May 14, 2025, at 4:20 PM PT - Location: Las Vegas, NV

2. Jefferies Global Healthcare Conference in New York: - President and CEO Paul Peter Tak will present on June 5, 2025, at 8:40 AM PT - Location: New York, NY

Live webcasts will be available on Candel's website under the Investors section, with replays archived for up to 90 days after the presentations.

Candel Therapeutics (Nasdaq: CADL) has announced that data from their phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer will be presented at the 2025 ASCO Annual Meeting. The presentation will feature results from a randomized, placebo-controlled study examining CAN-2409+prodrug combined with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer.

The oral presentation will be delivered by Dr. Theodore DeWeese, Dean of Medical Faculty and CEO of Johns Hopkins Medicine, on June 3, 2025, during the Genitourinary Cancer session at McCormick Place Convention Center, Chicago. Full abstracts will be released on May 22, 2025.