Century Therapeutics reports Q2 2026 results, FDA pre-IND meeting for T1D program
Century says CNTY-813's IND submission is on track for the fourth quarter of 2026 after aligning with FDA on trial design, while cash on hand grew to $197.2 million.
Century Therapeutics reported financial results and pipeline updates for the second quarter ended June 30, 2026, in an August 12, 2026 release. The company said it held a pre-IND meeting with the FDA and remains on track to submit an IND for CNTY-813 in the fourth quarter of 2026.1
At that meeting, Century and the FDA reached general alignment on the nonclinical data package, the proposed Phase 1 manufacturing process, and the Phase 1/2 clinical trial design1, covering an ongoing GLP toxicology study, the manufacturing and testing plan, and dosing and patient eligibility criteria for the Phase 1/2 trial.
Century also presented preclinical data for CNTY-813 at the 2026 American Diabetes Association Scientific Sessions in June. The company said the data showed glucose control sustained for more than eight months in vivo, along with immune evasion under allogeneic immune pressure without the use of immunosuppression1. Separately, the company said it had finalized its Phase 1 manufacturing bioreactor process for CNTY-813, with consistent performance, product quality, endocrine purity, and islet cell content shown across independent batches produced at the scale planned for the Phase 1 trial.1 The company said the IND submission remains on track for the fourth quarter of 2026, with initial clinical data expected in the second half of 2027.1
On the CAR-iT side, Century said it remains on track, after aligning with health authorities on nonclinical, manufacturing and Phase 1 parameters, to complete IND-enabling work for CNTY-308, and expects it to enter the clinic in 2026.1
Financially, cash, cash equivalents and investments totaled $197.2 million as of June 30, 2026, up from $117.1 million at the end of 2025, which the company estimates will fund operations into the first quarter of 2029.1 R&D expenses were $19.6 million for the quarter, down from $26.9 million a year earlier1, and net loss was $34.6 million, compared with a $32.5 million loss in the same period last year.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.