Candel Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights

   -- Recently announced positive data from pivotal randomized, 
      placebo-controlled phase 3 clinical trial of CAN-2409 in 
      intermediate-to-high risk, localized prostate cancer 
 
   -- Recently announced positive final data from randomized controlled phase 
      2a clinical trial of CAN-2409 in borderline resectable pancreatic ductal 
      adenocarcinoma 
 
   -- On track to report biomarker and final overall survival data from open 
      label phase 2a clinical trial per protocol analysis in non-small cell 
      lung cancer (NSCLC) patients who received two administrations of 
      CAN-2409, expected in Q1 2025 
 
   -- On track to report biomarker and initial survival data from ongoing phase 
      1b trial evaluating multiple doses of CAN-3110 in patients with recurrent 
      high-grade glioma (rHGG), expected in Q4 2025 
 
   -- Preparations for Biologics License Application $(BLA.AU)$ for CAN-2409 in 
      prostate cancer underway, with submission expected in Q4 2026 

NEEDHAM, Mass., March 13, 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, announced today financial results for the fourth quarter and year ended December 31, 2024, and provided a corporate update.

"Last year was transformational for Candel, driven by our team's incredible focus and execution of the Company's key priorities," said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. "We delivered positive data across our platforms, including pivotal topline phase 3 data for CAN-2409 in intermediate-to-high-risk localized prostate cancer in December, which we believe shows the potential of CAN-2409, if approved, to redefine the current standard of care for patients with prostate cancer."

Dr. Tak continued, "We enter 2025 well-resourced with a clear direction and mandate. Our primary focus for the year is working toward readiness to submit CAN-2409's BLA for prostate cancer, a key opportunity to address a very significant unmet need and opportunity for value creation. In addition, we continue to explore the efficacy of CAN-2409 in other indications, as evidenced by our recently disclosed positive final overall survival data for CAN-2409 in a randomized controlled phase 2a trial in borderline resectable pancreatic cancer. This result has triggered enabling work, which will include scientific advisory boards and engagement with the FDA, to get ready for a larger, late-stage, randomized clinical trial in this indication in the future. In addition, we anticipate final overall survival and biomarker data from our open label phase 2a clinical trial of CAN-2409 in therapy-resistant non-small cell lung cancer patients in the very near future. This study may also trigger similar enabling work. In Q4 2025, we will also provide a clinical and biomarker update from our ongoing phase 1b clinical trial evaluating multiple doses of CAN-3110 in patients with recurrent high-grade glioma. Finally, we have also made significant progress with our preclinical programs, leveraging the enLIGHTEN$(TM)$ Discovery Platform."

Fourth Quarter 2024 & Recent Highlights

   -- CAN-2409 - Pancreatic Cancer 
 
          -- Positive final survival data from the randomized controlled phase 
             2a clinical trial of CAN-2409 in borderline resectable pancreatic 
             ductal adenocarcinoma (PDAC), demonstrating notable improvement in 
             overall survival. Patients who had received experimental treatment 
             with CAN-2409 and standard of care achieved a median overall 
             survival of 31.4 months versus only 12.5 months observed in the 
             control arm treated with standard of care. 
 
          -- Notably, long-term survivors in the CAN-2409 arm remained alive at 
             66.0, 63.6, and 35.8-months post-enrollment, whereas only one 
             patient from the control arm was still alive at the time of data 
             cut-off (February 20, 2025). Patients in the experimental arm were 
             stable at the time of last follow up with minimal maintenance 
             therapy and, despite previous recurrence, experienced extended and 
             ongoing post-progression survival, further highlighting the 
             sustained benefit of CAN-2409, even in metastatic disease. 
 
          -- The U.S. Food and Drug Administration (FDA) previously granted 
             orphan drug designation and fast track designation for CAN-2409 in 
             borderline resectable PDAC. 
 
   -- CAN-2409 -- Prostate Cancer 
 
          -- In December 2024, the Company reported positive topline data from 
             its multicenter, randomized, placebo-controlled phase 3 clinical 
             trial evaluating CAN-2409 in intermediate-to-high-risk localized 
             prostate cancer patients. The study met its primary endpoint by 
             demonstrating statistically significant improvement in 
             disease-free survival $(DFS)$ in patients who received CAN-2409 plus 
             valacyclovir (prodrug) combined with standard of care external 
             beam radiation therapy (n=496) compared to standard of care alone 
             (n=249) within the intent to treat population. 
 
          -- The data showed a 30% reduction in the risk for prostate cancer 
             recurrence or death due to any cause for the CAN-2409 treatment 
             arm compared to placebo control arm (p=0.0155), and 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). The safety profile of CAN-2409 was generally 
             consistent with previous studies, with no new safety signals 
             identified. 
 
          -- This study was conducted under a Special Protocol Assessment $(SPA.UK)$ 
             agreed with the FDA, meaning that safety and efficacy data 
             generated from this study could be sufficient for the Company to 
             seek regulatory approval for CAN-2409 in this indication. 
 
          -- The FDA previously granted fast track designation for CAN-2409 for 
             the treatment of localized primary prostate cancer. 
 
   -- CAN-3110 -- Recurrent High-Grade Glioma 
 
          -- Presented updated clinical and biomarker activity data from cohort 
             C of a phase 1b clinical trial during the 6th Annual International 
             Oncolytic Virotherapy Conference (IOVC) in October 2024. The 
             Principal Investigator reported ongoing 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, respectively) 
             after initiation of experimental treatment with repeated 
             administrations of CAN-3110. 
 
          -- The FDA granted fast track designation and orphan drug designation 
             to CAN-3110 for the treatment of rHGG in February and May 2024, 
             respectively. 
 
   -- CAN-3110 -- Melanoma 
 
          -- Presented preclinical results on the therapeutic potential of 
             CAN-3110 in the Ras-Raf pathway altered melanoma model at the 
             Society for Immunotherapy of Cancer $(SITC)$ 2024 Annual Meeting. 
             CAN-3110 exhibited potent, tumor-specific cytotoxicity in human 
             and murine melanoma cell lines with varied CDKN2A pathway 
             alterations and Nestin expression. In vivo mouse studies showed 
             dose-dependent inhibition of tumor growth, with regression 
             observed in a subset (3 of 8) of tumor bearing animals treated 
             with a high dose of CAN-3110. CAN-3110 treatment was 
             well-tolerated in melanoma preclinical mouse models based on body 
             weight and histopathological analysis following intra-tumoral 
             administration. 
 
   -- enLIGHTEN(TM) Discovery Platform 
 
          -- Presented data on a new multimodal viral therapeutic candidate 
             encoding IL-12 and IL-15 during IOVC 2024. Data showed the ability 
             of the asset to induce expansion and activation of natural killer 
             and CD8+ T cell populations, resulting in significant tumor growth 
             inhibition and tumor regression in two different models. 
 
   -- Recent Corporate Events 
 
          -- In December 2024, the Company completed an underwritten public 
             offering of 12,000,001 shares of its common stock (inclusive of 
             the exercise of the underwriters' option to purchase additional 
             shares in full) at a price to the public of $6.00 per share, and 
             pre-funded warrants to purchase up to 3,333,333 shares of its 
             common stock at a price to the public of $5.99 per warrant with an 
             exercise price of $0.01 per pre-funded warrant, resulting in net 
             proceeds of approximately $85.9 million. The offering closed on 
             December 16, 2024. 

Anticipated Milestones

   -- Final overall survival data from phase 2a clinical trial evaluating 
      CAN-2409 in patients with NSCLC and an inadequate response to immune 
      checkpoint inhibitors, expected in Q1 2025. 
 
   -- Biomarker and initial overall survival data from ongoing phase 1b 
      clinical trial evaluating multiple doses of CAN-3110 in patients with 
      rHGG, expected in Q4 2025. 

Financial Results for the Year and Fourth Quarter Ended December 31, 2024

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March 13, 2025 16:15 ET (20:15 GMT)