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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 12, 2026
Century Therapeutics, Inc.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
001-40498 |
|
84-2040295 |
(State or other jurisdiction of
incorporation or organization) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
|
25
North 38th Street, 12th Floor
Philadelphia, Pennsylvania |
|
19104 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (267) 817-5790
25 North 38th Street, 11th Floor
Philadelphia, Pennsylvania
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class |
|
Trading Symbol |
|
Name
of Exchange on Which Registered |
| Common Stock, par value $0.0001 per share |
|
IPSC |
|
Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
| Item 2.02 |
Results of Operations and Financial Condition |
On November 12, 2026, Century Therapeutics, Inc. (the “Company”)
issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02 (including Exhibit 99.1)
is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by
reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific
reference in such filing.
| Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits
Exhibit
No. |
|
Document |
| |
|
|
| 99.1 |
|
Press Release of Century Therapeutics, Inc., dated November 12, 2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CENTURY THERAPEUTICS, INC. |
|
| |
|
|
| By: |
/s/ Brent Pfeiffenberger, Pharm.D., M.B.A. |
|
| Name: |
Brent Pfeiffenberger, Pharm.D., M.B.A. |
|
| Title: |
President, Chief Executive Officer and Chairman of the Board of Directors |
|
Date: November 12, 2026
Exhibit 99.1
Century Therapeutics Reports Third Quarter 2026 Financial Results
and Business Updates
| • | 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, November 12, 2026 –– 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 | |
