Century Therapeutics Locks In CNTY-813 IND Path After FDA Meeting
Cash, cash equivalents, and investments were $197.2 million as of June 30, 2026, with runway still estimated into the first quarter of 2029.
Century Therapeutics, Inc. (IPSC), a biotechnology company developing induced pluripotent stem cell–derived cell therapies for autoimmune diseases including type 1 diabetes, completed a pre-IND meeting with the FDA for CNTY-813 and said the investigational new drug application remains on track for the fourth quarter of 2026, with initial clinical data still expected in the second half of 2027.
The meeting was the quarter’s defining development. Century and the FDA reached general alignment on the nonclinical data package, the proposed Phase 1 manufacturing process, and a Phase 1/2 clinical trial design that includes dosing and patient eligibility criteria. A GLP toxicology study is ongoing and on track to support the planned submission.
That IND timing had already been stated in the first-quarter and full-year 2025 updates, so the pre-IND meeting did not move the calendar. It converted a stated plan into regulatory alignment on the data package, manufacturing, and trial design.
Preclinical data presented at the 2026 American Diabetes Association Scientific Sessions in June extended the duration previously disclosed. The company reported durable in vivo glucose control for more than eight months and immune evasion under allogeneic immune pressure without immunosuppression, versus the more-than-six-month normoglycemia duration it had described after full-year 2025 results. Century also said it had established a Phase 1 clinical manufacturing bioreactor process for CNTY-813, with consistent product quality, endocrine purity, and islet cell content across independent batches at the scale intended for the Phase 1 trial. Oral presentations on CNTY-813 are scheduled at EASD 2026 in Milan and the Breakthrough T1D Clinical & Research Congress in Philadelphia in October.
CNTY-308, a CD19-targeted CAR-iT cell therapy engineered with Allo-Evasion 5.0 for B-cell-mediated diseases, remained on track to enter the clinic in 2026 after aligning on nonclinical, manufacturing, and Phase 1 trial parameters with health authorities. That 2026 clinical-entry plan was unchanged from the prior two quarters.
Cash, cash equivalents, and investments were $197.2 million as of June 30, 2026, down from $217.0 million as of March 31, 2026. The company still estimates that balance will support operations into the first quarter of 2029. Cash and cash equivalents were $49.6 million and short-term investments were $70.1 million at June 30, with long-term investments of $77.5 million.
Research and development expenses were $19.6 million for the three months ended June 30, 2026, compared with $26.9 million a year earlier. Century attributed the decrease primarily to reductions in personnel and facility costs from previously announced portfolio prioritization. General and administrative expenses were $5.8 million. Collaboration revenue was zero, matching the year-ago quarter.
Net loss was $34.6 million for the quarter, or $0.17 a share, versus a $32.5 million loss, or $0.38 a share, a year earlier. Weighted-average common shares outstanding were 205.8 million. The quarter included an $11.1 million loss on lease component termination that did not appear in the year-ago period.
Chief Executive Officer Brent Pfeiffenberger said the company is executing against key development milestones and that CNTY-813 preclinical data at ADA 2026 continue to support its potential as a functional T1D cure.
The near-term path is unchanged in timing and sharpened in substance: a fourth-quarter 2026 IND for CNTY-813, Phase 1 manufacturing already established at trial scale, and CNTY-308 still slated for the clinic in 2026. Initial CNTY-813 clinical data remain expected in the second half of 2027.