Monitor for the CNTY-813 IND submission expected in Q4 2026, which is the next major catalyst. The preclinical data package appears supportive, but the stock remains binary on clinical execution and regulatory clearance.
Price Chart
Executive Summary
Century Therapeutics presented nonclinical data for CNTY-813, its iPSC-derived islet replacement therapy for type 1 diabetes, at the EASD 2026 meeting. The data demonstrated scalable manufacturing, durable glycemic control in diabetic mouse models, and immune-evasion capabilities via the Allo-Evasion 5.0 platform. The company reiterated its timeline for an IND submission in Q4 2026 and initial clinical data in the second half of 2027.
Key Facts
- Nonclinical data for CNTY-813 presented at EASD 2026 in Milan, Italy on October 2, 2026.
- CNTY-813 is an iPSC-derived islet replacement therapy engineered with Allo-Evasion 5.0 for type 1 diabetes.
- Five clinical-scale batches from GMP Master Cell Bank produced consistent final product profiles.
- CNTY-813 maintained glycemic control in diabetic mice for over 11 months until graft removal.
- No tumorigenesis observed in >140 mice with >3-month follow-up (>1B cells infused).
- IND submission remains on track for Q4 2026; initial clinical data anticipated in 2H 2027.
- Company reached general alignment with FDA on nonclinical package, Phase 1 manufacturing process, and proposed Phase 1/2 trial design.
Financial Impact
No financial figures reported in the filing.
Risk Factors
- Preclinical data may not predict clinical outcomes.
- IND submission and clinical trial timelines are subject to regulatory and operational risks.
- No revenue or financial data provided; company is pre-commercial with no approved products.
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-113055 |
| Document: tm2626840d1_ex99-2.htm | 0001104659-26-113055 |
| Document: tm2626840d1_ex99-1.htm | 0001104659-26-113055 |
| Document: 0001104659-26-113055-index-headers.html | 0001104659-26-113055 |
| Document: 0001104659-26-113055-index.html | 0001104659-26-113055 |
| Document: 0001104659-26-113055.txt | 0001104659-26-113055 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 2, 2026 24d ago | 8-K | $1.53 $1.48 | ▼ −3.27% | ▼ −3.94% | $1.42 (−7.19%) |
Oct 2, 2026 24d ago | Press Release | $1.53 $1.48 | ▼ −3.27% | ▼ −3.94% | $1.42 (−7.19%) |
Sep 22, 2026 4w ago | Institutional Cluster | $1.89 $1.76 | ▼ −6.88% | ▼ −6.16% | $1.42 (−24.87%) |
Sep 10, 2026 6w ago | 3 | $1.94 $2.00 | ▲ +3.09% | ▲ +3.54% | $1.42 (−26.80%) |
Aug 12, 2026 10w ago | 8-K | $1.96 $1.93 | ▼ −1.53% | ▼ −2.23% | $1.42 (−27.55%) |
Aug 12, 2026 10w ago | Press Release | $1.96 $1.93 | ▲ +1.53% | ▲ +2.23% | $1.42 (+27.55%) |
Jun 16, 2026 18w ago | 8-K | $2.25 $2.29 | ▲ +1.78% | ▲ +1.00% | $1.42 (−36.89%) |
Jun 15, 2026 19w ago | Insider Cluster | $2.18 $2.25 | ▲ +3.21% | ▲ +4.46% | $1.42 (−34.86%) |
Jun 9, 2026 19w ago | Insider Cluster | $2.12 $2.24 | ▲ +5.66% | ▲ +3.96% | $1.42 (−33.02%) |
Jun 9, 2026 19w ago | Insider Cluster | $2.12 $2.24 | ▲ +5.66% | ▲ +3.96% | $1.42 (−33.02%) |
US Market Status
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