PHILADELPHIA, PA — Century Therapeutics, Inc. (NASDAQ: IPSC) is targeting a fourth-quarter 2026 regulatory filing for its experimental type 1 diabetes cell therapy after reaching general alignment with the U.S. Food and Drug Administration on its preclinical package, manufacturing strategy and proposed Phase 1/2 trial design, putting the biotechnology company on a path toward initial human data in the second half of 2027.
The Philadelphia-based company reported the regulatory progress for CNTY-813 alongside second-quarter results, including $197.2 million in cash, cash equivalents and investments as of June 30. Century expects that capital to fund operations into the first quarter of 2029.
CNTY-813 is an induced pluripotent stem cell-derived islet replacement therapy engineered to evade immune responses. Century is developing the treatment as a potential functional cure for type 1 diabetes without requiring immunosuppression.
A recent pre-IND meeting with the FDA produced general agreement on the nonclinical data package, Phase 1 manufacturing process and proposed clinical design, according to Century. An ongoing GLP toxicology study remains on schedule to support the planned investigational new drug application.
The proposed Phase 1/2 trial parameters discussed with regulators include dosing and patient eligibility criteria. Century also established a manufacturing and testing plan covering its cell bank, intermediate products and final drug product.
Chief Executive Officer Brent Pfeiffenberger characterized the FDA discussions as supporting the company’s fourth-quarter filing timeline, noting that Century has established its Phase 1 manufacturing process and demonstrated consistent product quality across independent batches.
The regulatory push follows preclinical findings presented at the American Diabetes Association Scientific Sessions in June. Century reported that CNTY-813 maintained glucose control for more than eight months in vivo and demonstrated immune evasion under allogeneic immune pressure without immunosuppression.
Those findings are preclinical and do not establish that the therapy will produce comparable outcomes in people. Century expects initial clinical data in the second half of 2027 if development proceeds as planned.
The company also reported that it has established the Phase 1 bioreactor manufacturing process at the scale intended for clinical testing, with independent batches demonstrating consistent process performance, endocrine purity and islet-cell content.
Additional CNTY-813 preclinical findings are scheduled for presentation at the European Association for the Study of Diabetes meeting in Milan on Oct. 2 and the Breakthrough T1D Clinical & Research Congress in Philadelphia on Oct. 9.
Century is simultaneously advancing CNTY-308, a CD19-targeted CAR-iT cell therapy designed for B-cell-mediated diseases. The company expects to complete IND-enabling work and move the program into clinical development in 2026 after discussions with health authorities covering nonclinical, manufacturing and Phase 1 parameters.
Preclinical testing of CNTY-308 showed functional comparability to primary CAR-T cells in measures including target-driven proliferation, cytokine secretion and persistence, according to the company. Century is seeking to develop the therapy as an allogeneic alternative to patient-specific autologous CAR-T treatments.
The company’s cash position increased to $197.2 million at June 30 from $117.1 million at the end of 2025.
Research and development expenses fell 27% to $19.6 million in the second quarter from $26.9 million a year earlier, primarily because of personnel reductions and lower facility costs following an earlier portfolio prioritization.
General and administrative expenses declined to $5.8 million from $7.8 million.
Century’s quarterly net loss nevertheless widened to $34.6 million from $32.5 million in the same period of 2025 as the company continues funding development of its cell-therapy pipeline.
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