PHILADELPHIA, PA — Century Therapeutics, Inc. (Nasdaq: IPSC) said it remains on track to seek regulatory clearance next year for its experimental type 1 diabetes cell therapy as the company expands development of stem cell-based treatments for autoimmune disease and cancer.
Century expects to submit an investigational new drug application for CNTY-813 in the fourth quarter of 2026, with initial clinical data anticipated in the second half of 2027.
The therapy is designed as an induced pluripotent stem cell-derived islet replacement treatment intended to restore insulin production in patients with type 1 diabetes.
Chief Executive Officer Brent Pfeiffenberger said the company believes the program is advancing on a competitive timeline relative to other diabetes cell therapy efforts.
“With an IND submission expected in the fourth quarter of 2026 and initial clinical data anticipated in the second half of 2027, our focus is clear: to deliver a differentiated, patient-centric, potentially curative approach for people with type 1 diabetes,” Pfeiffenberger stated.
Century said recent progress included completion of manufacturing for its GMP master cell bank, advancement of IND-enabling studies, and additional FDA engagement supporting regulatory preparation.
The company also announced plans to present preclinical data related to CNTY-813 at the American Diabetes Association Scientific Sessions on June 8. According to Century, the presentation will highlight scalable production of engineered islet cells designed to evade immune system rejection.
Separately, Century stated that CNTY-308, its CD19-targeted CAR-iT cell therapy program for B-cell-mediated diseases, remains on track to enter clinical testing this year pending regulatory clearance.
Cash, cash equivalents, and marketable securities totaled $217.0 million as of March 31, compared with $117.1 million at the end of 2025 following a previously disclosed $135 million private placement completed in January.
The company projected its current cash position will fund operations into the first quarter of 2029.
Research and development expenses declined to $17.1 million during the quarter from $26.6 million a year earlier, driven primarily by lower personnel and clinical trial costs.
Century reported a net loss of $21.6 million for the quarter ended March 31, compared with net income of $76.6 million during the same period in 2025.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.