PHILADELPHIA, PA — Century Therapeutics Inc. (Nasdaq: IPSC) reported its financial results for 2025 and outlined progress across its pipeline of stem cell-derived therapies, including plans to submit a regulatory application in 2026 for a potential treatment targeting type 1 diabetes.
The biotechnology company said its lead program, CNTY-813, is advancing through investigational new drug-enabling studies, with plans to submit an application to the U.S. Food and Drug Administration in the fourth quarter of 2026.
Century said it expects initial clinical data from the program in the second half of 2027.
CNTY-813 is designed as a beta islet replacement therapy intended to restore insulin-producing cells in patients with type 1 diabetes.
Chief Executive Officer Brent Pfeiffenberger said the company is prioritizing the program as it advances toward human studies.
“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,” Pfeiffenberger said.
The company said preclinical studies have shown the therapy can maintain normal glucose levels in animal models for more than six months.
Century is also advancing CNTY-308, a CD19-targeted CAR-iT cell therapy designed to treat B-cell–mediated diseases.
The company said the therapy remains in investigational new drug-enabling studies and is expected to enter clinical trials in 2026, pending regulatory clearance.
Century also expects additional data in 2026 from the CARAMEL study, a Phase 1/2 investigator-sponsored clinical trial evaluating CNTY-101 in autoimmune diseases.
Previously reported data from the study indicated the therapy was generally well tolerated and showed early signs of clinical activity, according to the company.
Separately, Century said it completed an oversubscribed $135 million private placement in January 2026.
The financing was led by TCGX and included participation from investors such as RA Capital Management, Commodore Capital, Deep Track Capital, RTW Investments, Venrock Healthcare Capital Partners, and the T1D Fund.
Century said the funding strengthened its balance sheet and is expected to extend its cash runway into the first quarter of 2029.
The company reported cash, cash equivalents, and marketable securities of $117.1 million as of December 31, 2025, compared with $220.1 million a year earlier.
Collaboration revenue totaled $109.2 million for the year, largely related to the company’s partnership with Bristol Myers Squibb, compared with $6.6 million in 2024.
Research and development expenses were $95.7 million in 2025, down from $107.2 million the prior year.
General and administrative expenses totaled $24.0 million, compared with $33.2 million in 2024.
Century reported a net loss of $9.6 million for 2025, compared with a net loss of $126.6 million the previous year.
The company also said it appointed Han Lee and Martin Murphy to its board of directors in December 2025.
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