PHILADELPHIA, November 13, 2025 — Leads & Copy — Century Therapeutics, Inc. (NASDAQ: IPSC) reported its third-quarter financial results for 2025 and provided a business update, including its iPSC derived beta islet program for Type 1 diabetes (T1D).
Century Therapeutics anticipates initiating Investigational New Drug (IND)-enabling studies by the end of 2025 and plans to submit an IND in 2026 for its iPSC derived beta islet program for T1D.
According to Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics, the company has generated a compelling preclinical data package, underscoring the potential to deliver a functional cure for T1D. The company is moving with urgency and anticipates initiating IND-enabling studies by the end of 2025, with a projected IND submission as early as 2026. Century Therapeutics also plans to enter the clinic next year with CNTY-308, supported by a growing body of evidence from autologous CD19 CAR-T experience in autoimmune diseases.
Century Therapeutics is focusing its resources and expertise on the beta islet program and CNTY-308. Pfeiffenberger believes Century is uniquely positioned to deliver potentially curative cell therapies with its iPSC Cell Foundry, Allo-Evasion™ 5.0 technology, and manufacturing know-how.
Highlights from the third quarter of 2025 and recent developments include:
- Century announced its lead iPSC derived beta islet program, CNTY-813, for T1D, engineered with Allo-Evasion™ 5.0. The company has generated in vitro and in vivo data sets that validate a profile of rapid and sustained glucose control without the need for chronic immune suppression, along with a scalable platform. Century expects to move CNTY-813 into IND-enabling studies by the end of 2025 and anticipates submitting an IND as early as 2026.
- Century is making progress in IND-enabling studies with CNTY-308, a CD19-targeted CD4+/CD8+ ab CAR-iT cell therapy engineered with Allo-Evasion™ 5.0, as a potential treatment for B-cell-mediated diseases. Following successful completion of these studies and regulatory approval, Century expects to initiate clinical studies in 2026.
- CNTY-101 clinical development activities will continue in CARAMEL, a Phase 1/2 investigator-sponsored trial (IST). As of November 12, 2025, three B-cell-mediated autoimmune disease patients were treated in this IST. Initial clinical data from CARAMEL is expected to be presented by the trial investigators at the 14th Annual BMT & Cell Therapy Workshop on December 5, 2025. Century will discontinue its company-sponsored CALiPSO-1 trial as part of its clinical development re-prioritization efforts.
As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $132.7 million, compared to $220.1 million as of December 31, 2024. The company estimates its cash, cash equivalents, and investments will support operations into the fourth quarter of 2027.
- Research and Development (R&D) Expenses: R&D expenses were $22.5 million for the three months ended September 30, 2025, compared to $27.2 million for the same period in 2024.
- General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the three months ended September 30, 2025, compared to $8.4 million for the same period in 2024.
- Net Income (Loss): Net loss was $34.4 million for the three months ended September 30, 2025, compared to net loss of $31.2 million for the same period in 2024.
Century Therapeutics (NASDAQ: IPSC) is advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to address autoimmune diseases and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its Allo-Evasion™ technology.
Douglas Carr
Senior Vice President, Finance
investor.relations@centurytx.com
Sarah McCabe
JPA Health
smccabe@jpa.com
Source: Century Therapeutics, Inc
