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Century Therapeutics Presents Nonclinical Data for CNTY-813
Century Therapeutics announced the presentation of nonclinical data for CNTY-813, Century's iPSC-derived islet replacement therapy engineered with Allo-Evasion 5.0. Data were presented in an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes, EASD, in Milan, Italy. In a study lasting over eleven months, updated data demonstrated CNTY-813 maintained glycemic control in a diabetic mouse model until CNTY-813's graft removal. New data further highlighted CNTY-813's anticipated readiness for clinical testing via demonstration of drug product consistency across five clinical-scale runs, glycemic control in a diabetic mouse model after extended drug product cold storage, and successful engraftment of CNTY-813 via the intended clinical route of administration.
Century Therapeutics Presents Nonclinical Data for CNTY-813
Century Therapeutics announced the presentation of nonclinical data for CNTY-813, Century's iPSC-derived islet replacement therapy engineered with Allo-Evasion 5.0. Data were presented in an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes, EASD, in Milan, Italy. In a study lasting over eleven months, updated data demonstrated CNTY-813 maintained glycemic control in a diabetic mouse model until CNTY-813's graft removal. New data further highlighted CNTY-813's anticipated readiness for clinical testing via demonstration of drug product consistency across five clinical-scale runs, glycemic control in a diabetic mouse model after extended drug product cold storage, and successful engraftment of CNTY-813 via the intended clinical route of administration.
Century Therapeutics Advances CNTY-813 Development Progress
"We are executing with speed against key development milestones, reinforcing our confidence in delivering on our ambition to transform diseases like T1D by creating functional cures at scale," said Brent Pfeiffenberger, Chief Executive Officer of Century Therapeutics. "With CNTY-813, our preclinical data at ADA 2026 continue to support its potential as a functional T1D cure, and we have established our Phase 1 manufacturing process, demonstrating consistent product quality across independent batches. Our recent pre-IND meeting with the FDA builds on that progress yielding alignment with the FDA on our nonclinical data package, manufacturing strategy, and proposed Phase 1/2 trial design, keeping CNTY-813's IND submission on track for the fourth quarter of 2026. In addition, CNTY-308 remains on track to enter the clinic in 2026."
Century Therapeutics Advances CNTY-813 Development Progress
"We are executing our pipeline with discipline to deliver an iPSC-derived islet replacement therapy to patients. The progress of CNTY-813 highlights what Century can achieve pairing our Allo-Evasion engineering with a scalable iPSC platform," said Brent Pfeiffenberger, Chief Executive Officer of Century Therapeutics. "In a relatively short time since initiating this program, we have advanced CNTY-813 into IND-enabling studies on a timeline we believe is highly competitive with leading efforts in the field. 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 while continuing to expand our autoimmune disease portfolio with CNTY-308."
Century Therapeutics Reports FY25 Revenue of $109.164M
Reports FY25 revenue $109.164M, consensus $109.17M. "Century entered 2026 with strong momentum, fueled by the successful completion of our $135 million private placement and continued focus on advancing our prioritized programs closer to patients living with significant unmet medical need," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. "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. Recent achievements, including compelling preclinical results combined with constructive interactions with the FDA, strengthen our confidence in the clinical path ahead. We plan to submit an IND as early as the fourth quarter of this year and anticipate initial clinical data in the second half of 2027. We are energized by the progress across our pipeline, confident in the road ahead, and focused on advancing our most promising programs into the clinic."
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