- CNTY-813, an iPSC-derived islet replacement therapy for T1D, presented new nonclinical data at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) and remains on track for IND submission in 4Q 2026; initial clinical data anticipated in 2H 2027
- CNTY-308, a CD19-targeted CAR-iT cell therapy with Allo-Evasion™ 5.0, remains on track to enter the clinic this year
- Cash runway into 1Q 2029 with cash, cash equivalents, and investments of $174.1 million as of September 30, 2026
PHILADELPHIA, Nov. 12, 2026 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune disease, including type 1 diabetes, and other severe diseases where engineered iPSCs have the unique potential to transform patients’ lives, today reported financial results for the third quarter ended September 30, 2026, and recent business highlights.
“We remain focused on disciplined execution as we rapidly advance our two potentially transformational programs, including CNTY-813, which has the potential to be a functional cure for type 1 diabetes, toward the clinic over the coming months,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “This progress reflects the rigor of our science, the uniqueness of our expertise, and integrated capabilities to translate promising technologies into meaningful new treatment options for patients. With general alignment reached with the FDA for both programs, we remain on track this year for clinical entry of CNTY-308 and IND submission of CNTY-813, positioning us for an important transition to clinical execution in 2027.”
Third Quarter 2026 and Recent Highlights
Oral presentation at EASD 2026: CNTY-813 data further support advancement to the clinic (link to press release HERE)
- Allo-Evasion™ 5.0-edited CNTY-813 islets rapidly restored normoglycemia in streptozotocin-induced diabetic mice and maintained glycemic control until graft removal in a study lasting more than eleven months.
- All streptozotocin-induced diabetic mice administered CNTY-813 achieved normoglycemia, and CNTY-813 islets showed glucose-stimulated insulin secretion potency similar to that of primary islets.
- Five clinical-scale batches from Century’s GMP Master Cell Bank produced consistent final product profiles, with the final product exceeding purity criteria.
- In rats, CNTY-813 islets delivered via the liver portal vein were found to have engrafted in the liver at one month post-transplant and stained positive for insulin and chromogranin A, markers of β cells and endocrine cells, respectively.
- Mice transplanted with clinical-scale islets after 96 hours of cold storage normalized blood glucose within 30 days and maintained normoglycemia through three months of follow-up, thereby supporting the planned clinical supply chain strategy.
CNTY-813 IND submission remains on track for 4Q 2026
- Century expects to submit an IND for CNTY-813 in the fourth quarter of 2026.
- Following the pre-IND meeting, Century and the FDA reached general alignment on the nonclinical data package, the Phase 1 manufacturing process, and the proposed Phase 1/2 clinical trial design.
- Initial safety and early efficacy data from the first-in-human CNTY-813 study are anticipated in 2H 2027.
CNTY-308 clinical trial planned to initiate in 2026
- Century aligned with health authorities on nonclinical, manufacturing, and Phase 1 parameters. CNTY-308 is anticipated to enter the clinic in 2026.
- In nonclinical studies, CNTY-308 demonstrated functional comparability to autologous primary CAR-T cells, including in target-driven proliferation, cytokine secretion, and persistence. Autologous CAR-T cells have shown clinical proof of concept across several autoimmune diseases.
Joseph Truitt appointed to Board of Directors
Century announced the appointment of Joseph Truitt to its Board of Directors. Mr. Truitt is Chief Executive Officer of iECURE, Inc. and Chairman of the Board of Larimar Therapeutics, and previously served as Chief Executive Officer of BioSpecifics Technologies Corp. and Achillion Pharmaceuticals.
Third Quarter 2026 Financial Results
- Cash Position: Cash, cash equivalents, and investments were $174.1 million as of September 30, 2026, as compared to $117.1 million as of December 31, 2025. The company estimates its cash, cash equivalents, and investments as of September 30, 2026 will support operations into 1Q 2029.
- Research and Development (R&D) Expenses: R&D expenses were $18.1 million for the quarter ended September 30, 2026, compared to $22.5 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 $7.1 million for the quarter ended September 30, 2026, compared to $6.8 million for the same period in 2025.
- Net Loss: Net loss was $23.5 million for the quarter ended September 30, 2026, compared to a net loss of $34.4 million for the same period in 2025.
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune disease, including type 1 diabetes, and other severe diseases where engineered iPSCs have the unique potential to transform patients’ lives. Century’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care. For more information on Century Therapeutics, please visit www.centurytx.com and connect with us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements about our timing and expectations regarding our nonclinical and clinical development programs, including their planned development, therapeutic potential and market opportunity, ongoing and planned regulatory submissions and interactions, the achievement of developmental milestones, corporate strategies, anticipated data readouts, and our financial resources and expected cash runway are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, nonclinical studies, and clinical trials; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; our ability to obtain clearance of our future IND or CTA submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, trade disputes and tariffs, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to obtain additional funding when needed and the accuracy of our estimates regarding our cash runway; the non-binding nature of feedback from the FDA and other regulatory authorities; the risk that results in animal models may not be predictive of results in humans; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
For More Information:
Century Therapeutics
Douglas Carr
Senior Vice President, Finance
investor.relations@centurytx.com
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
cdavis@lifesciadvisors.com
| Century Therapeutics, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Unaudited, in thousands, except share amounts) | ||||||||
| September 30, 2026 | December 31, 2025 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 45,016 | $ | 61,853 | ||||
| Short-term investments | 72,185 | 55,261 | ||||||
| Prepaid expenses and other current assets | 5,512 | 3,655 | ||||||
| Total current assets | 122,713 | 120,769 | ||||||
| Property and equipment, net | 32,832 | 50,026 | ||||||
| Operating lease right-of-use assets | 13,394 | 16,139 | ||||||
| Long-term investments | 56,924 | — | ||||||
| Intangible assets | 34,200 | 34,200 | ||||||
| Other long-term assets | 2,563 | 2,570 | ||||||
| Total assets | $ | 262,626 | $ | 223,704 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,983 | $ | 4,773 | ||||
| Accrued expenses and other liabilities | 11,062 | 11,696 | ||||||
| Contingent consideration liability, short-term | — | 3,757 | ||||||
| Total current liabilities | 14,045 | 20,226 | ||||||
| Operating lease liability, long term | 33,647 | 40,241 | ||||||
| Other long-term liabilities | 666 | — | ||||||
| Deferred tax liability | 4,301 | 4,301 | ||||||
| Total liabilities | 52,659 | 64,768 | ||||||
| Common stock | 18 | 9 | ||||||
| Additional paid-in capital | 1,082,652 | 950,814 | ||||||
| Accumulated deficit | (871,565 | ) | (791,917 | ) | ||||
| Accumulated other comprehensive income | (1,138 | ) | 30 | |||||
| Total stockholders’ equity | 209,967 | 158,936 | ||||||
| Total liabilities and stockholders’ equity | $ | 262,626 | $ | 223,704 | ||||
| Century Therapeutics, Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | ||||||||||||||||
| (unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | |||||||||||||
| September 30, 2026 | September 30, 2025 | September 30, 2026 | September 30, 2025 | |||||||||||||
| Collaboration revenue | $ | — | $ | — | $ | — | $ | 109,164 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 18,060 | 22,526 | 54,760 | 75,972 | ||||||||||||
| General and administrative | 7,146 | 6,835 | 19,512 | 23,047 | ||||||||||||
| Loss on lease component termination | — | — | 11,145 | — | ||||||||||||
| Impairment of long-lived assets | — | 6,763 | — | 6,763 | ||||||||||||
| Total operating expenses | 25,206 | 36,124 | 85,417 | 105,782 | ||||||||||||
| Income (loss) from operations | (25,206 | ) | (36,124 | ) | (85,417 | ) | 3,382 | |||||||||
| Interest income | 1,753 | 1,605 | 5,754 | 6,037 | ||||||||||||
| Other income (expense), net | — | 97 | 15 | 172 | ||||||||||||
| Total other income | 1,753 | 1,702 | 5,769 | 6,209 | ||||||||||||
| Net income (loss) | $ | (23,453 | ) | $ | (34,422 | ) | $ | (79,648 | ) | $ | 9,591 | |||||
| Unrealized loss on investments | (444 | ) | (19 | ) | (1,168 | ) | (260 | ) | ||||||||
| Comprehensive income (loss) | $ | (23,897 | ) | $ | (34,441 | ) | $ | (80,816 | ) | $ | 9,331 | |||||
| Net income (loss) per common share, basic and diluted | (0.11 | ) | (0.40 | ) | (0.39 | ) | 0.11 | |||||||||
| Weighted average common shares outstanding, basic | 206,438,860 | 86,464,066 | 201,944,356 | 86,312,863 | ||||||||||||
| Weighted average common shares outstanding, diluted | 206,438,860 | 86,464,066 | 201,944,356 | 86,390,294 | ||||||||||||
