On August 12, 2026 Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases, including T1D, and cancer, reported financial results for the second quarter ended June 30, 2026, and recent business highlights.
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"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, Pharm.D., 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."
Second Quarter 2026 and Recent Highlights
Pre-IND meeting with the FDA supports regulatory and initial clinical path for CNTY-813
· Following a recent pre-IND meeting with the FDA, Century remains on track to submit an IND for CNTY-813 in the fourth quarter of 2026.
· 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 design which includes alignment on:
o GLP toxicology study, which is ongoing and on track to support the planned submission.
o Phase 1 manufacturing process and testing plan that includes cell bank, intermediate, and final drug product release tests.
o Proposed Phase 1/2 clinical trial including dosing and patient eligibility criteria.
· New preclinical data further support CNTY-813 as a potential functional cure for T1D; data were presented at the 2026 American Diabetes Association (ADA) Scientific Sessions in June (link to press release HERE).
Data demonstrated key advancements for CNTY-813 including:
o Durable in vivo glucose control maintained for more than eight months and immune evasion under allogeneic immune pressure without immunosuppression.
o Consistent and scalable product quality and performance at Phase 1 clinical trial scale.
· IND submission remains on track for 4Q 2026, with initial clinical data expected in 2H 2027.
CNTY-813 Phase 1 manufacturing process established
· Century has established its Phase 1 clinical manufacturing bioreactor process for CNTY-813, demonstrating consistent process performance and product quality, endocrine purity, and optimal islet cell content across independent batches run at the same scale intended for the Phase 1 clinical trial.
CNTY-813 preclinical data selected for oral presentations at congresses this fall
· 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2026; Milan, Italy; Presentation #225, Paris Hall, October 2nd, 2026, 10-11 AM CEST)
· Breakthrough T1D Clinical & Research Congress 2026 (CRC 2026; Philadelphia, Pennsylvania; Presentation #341, Hall 1, October 9th, 2026, 3:50- 4:50 PM EST)
· Both presentations will highlight CNTY-813, Century’s iPSC-derived islet replacement therapy program engineered with Allo-Evasion 5.0 for patients with T1D.
CNTY-308 clinical trial planned to initiate in 2026
· Century remains on track, after aligning on nonclinical, manufacturing and Phase 1 clinical trial parameters with health authorities, to complete IND-enabling activities for CNTY-308, a CD19-targeted CD4⁺/CD8⁺ αβ CAR-iT cell therapy engineered with Allo-Evasion 5.0 for B-cell-mediated diseases. CNTY-308 is anticipated to enter the clinic in 2026.
· Preclinical data showed functional comparability to primary CAR-T cells, including target-driven proliferation, cytokine secretion, and durable persistence. Collectively, these results and the expanding clinical validation of CAR-T therapy support Century’s confidence that CNTY-308 could deliver autologous-like benefits in an allogeneic, patient-centric format designed to broaden access.
Second Quarter 2026 Financial Results
· Cash Position: Cash, cash equivalents, and investments were $197.2 million as of June 30, 2026, as compared to $117.1 million as of December 31, 2025. The company estimates its cash, cash equivalents, and investments as of June 30, 2026 will support operations into 1Q 2029.
· Research and Development (R&D) Expenses: R&D expenses were $19.6 million for the quarter ended June 30, 2026, compared to $26.9 million for the same period in 2025. The decrease was primarily the result of a reduction in personnel and a reduction in facility costs as a result of our previously announced portfolio prioritization.
· General and Administrative (G&A) Expenses: G&A expenses were $5.8 million for the quarter ended June 30, 2026, compared to $7.8 million for the same period in 2025.
· Net Income (Loss): Net (loss) was $34.6 million for the quarter ended June 30, 2026, compared to net (loss) of $32.5 million for the same period in 2025.
(Press release, Century Therapeutics, AUG 12, 2026, View Source [SID1234670004])