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Century Therapeutics Reports Full Year 2025 Financial Results and Business Updates

Century Therapeutics Reports Full Year 2025 Financial Results and Business Updates

Table of Contents

Century Therapeutics, Inc.
  • CNTY-813, lead beta islet cell therapy program as a potential functional cure for type 1 diabetes, in Investigational New Drug (IND)-enabling studies; IND submission expected in 4Q 2026 to support anticipated initial clinical data in 2H 2027

  • CNTY-308, a CD19-targeted CAR-iT cell therapy engineered with Allo-Evasion™ 5.0, on track to enter the clinic in 2026

  • Strengthened balance sheet and cash runway extended into 1Q 2029 from oversubscribed $135 million private placement in January 2026

PHILADELPHIA, March 12, 2026 (GLOBE NEWSWIRE) — Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases, including type 1 diabetes, and cancer, today reported financial results for the full year ended December 31, 2025, and recent business highlights.

“Century entered 2026 with strong momentum, fueled by the successful completion of our $135 million private placement and continued focus on advancing our prioritized programs closer to patients living with significant unmet medical need,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “We are moving fast and executing with precision on CNTY-813, our top priority and a program we believe has the potential to functionally cure type 1 diabetes. Recent achievements, including compelling preclinical results combined with constructive interactions with the FDA, strengthen our confidence in the clinical path ahead. We plan to submit an IND as early as the fourth quarter of this year and anticipate initial clinical data in the second half of 2027. We are energized by the progress across our pipeline, confident in the road ahead, and focused on advancing our most promising programs into the clinic.”

Fourth Quarter 2025 and Recent Highlights

Pipeline

  • CNTY-813, priority program for type 1 diabetes, advancing through IND-enabling activities and tracking toward planned IND submission in 2026: Century continues to advance IND-enabling studies for its lead pipeline program, CNTY-813, a beta islet replacement therapy with Allo-Evasion™ 5.0 as a potential functional cure for type 1 diabetes. To date, Century has generated compelling preclinical data for CNTY-813, demonstrating high potency and long duration for functional glucose control and protection against immune rejection via Allo-Evasion™ 5.0 engineering to potentially minimize or eliminate the need for chronic immunosuppression. This data package, which includes the maintenance of normoglycemia in animal models for more than 6 months, completion of the manufacturing of a GMP Master Cell Bank for CNTY-813, along with recent engagement with the U.S. Food and Drug Administration (FDA), has reinforced the company’s belief in an efficient pathway to IND submission for CNTY-813. Century expects to submit an IND for the program in the fourth quarter of 2026 and anticipates initial clinical data in the second half of 2027.

  • CNTY-308 advancing in IND-enabling studies for projected clinical entry in 2026: Century continues to make progress in IND-enabling studies with CNTY-308, a CD19-targeted CD4+/CD8+ ab CAR-iT cell therapy with Allo-Evasion™ 5.0 as a potential treatment for B-cell-mediated diseases. In previously presented preclinical studies, CNTY-308 demonstrated functional comparability to primary CAR-T cells, including target-mediated proliferation, cytokine secretion, and long-term persistence. These data, coupled with the growing academic and industry experience with CAR-T treatment supporting its potential to deliver deep and durable responses in patients, reinforce Century’s belief in CNTY-308 to deliver autologous, CAR-T-like clinical benefits in an allogeneic, patient-centric format for enhanced treatment accessibility. Subject to completion of IND-enabling studies and regulatory clearance, Century expects CNTY-308 to enter the clinic in 2026.

  • Additional insights from ongoing CARAMEL IST expected in 2026: The company anticipates updated preliminary clinical data this year from the ongoing CARAMEL study, a Phase 1/2 investigator-sponsored trial (IST) led by Professors Georg Schett and Andreas Mackensen and sponsored by the Friedrich-Alexander University Erlangen-Nürnberg. Previously disclosed clinical data from the trial have demonstrated that CNTY-101 was generally well tolerated and exhibits a predictable biologic profile with early signs of clinical response in autoimmune diseases.

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