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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):
May 13, 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, 11th Floor
Philadelphia, Pennsylvania |
|
19104 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (267) 817-5790
Not Applicable
(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 May 13, 2026, Century Therapeutics, Inc. (the “Company”)
issued a press release announcing its financial results for the quarter ended March 31, 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 May 13, 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. |
| |
Name: |
Brent Pfeiffenberger, Pharm.D. |
| |
Title: |
President and Chief Executive Officer |
Date: May 13, 2026
Exhibit 99.1
Century Therapeutics Reports First Quarter Financial Results
and Business Updates
| · | CNTY-813, Century’s type 1 diabetes iPSC-derived islet therapy
with functional-cure potential, remains on track for IND in 4Q 2026; initial
clinical data expected in 2H 2027 |
| · | Upcoming oral presentation at the American Diabetes Association (ADA) annual Scientific Sessions highlighting CNTY-813
preclinical data on June 8, 2026 |
| · | On track to advance CNTY-308, Century’s CD19-targeted
CAR-iT cell therapy, into the clinic this year |
| · | Cash runway into 1Q 2029 with cash, cash equivalents, and marketable securities of $217.0 million as of March 31, 2026 |
PHILADELPHIA, May 13,
2026 -- Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced
pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases, including type 1 diabetes, and cancer, today reported financial
results for the first quarter ended March 31, 2026, and recent business highlights.
“We
are executing our pipeline with discipline to deliver an iPSC-derived islet replacement therapy to patients. The progress of CNTY-813
highlights what Century can achieve pairing our Allo-Evasion™ engineering
with a scalable iPSC platform,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “In
a relatively short time since initiating this program, we have advanced CNTY-813
into IND-enabling studies on a timeline we believe is highly competitive
with leading efforts in the field. With an IND submission expected in the fourth quarter of 2026 and initial clinical data anticipated
in the second half of 2027, our focus is clear: to deliver a differentiated, patient-centric,
potentially curative approach for people with type 1 diabetes while continuing to expand our autoimmune disease portfolio with CNTY-308.”
First Quarter 2026 and Recent Highlights
Pipeline
| · | CNTY-813, Century’s priority program in type 1 diabetes,
reflects strong execution: During Q1 2026, the company made meaningful progress across key IND-enabling
activities, including non-clinical development, manufacturing, and regulatory
readiness, supporting a clear line of sight to the clinic. Progress to date includes compelling preclinical data showing durable glucose
control and immune protection, completion of GMP Master Cell Bank manufacturing, and recent FDA engagement, further de-risking
the program. Building on this momentum, Century expects to submit an IND in 4Q 2026,
subject to completion of remaining studies, and anticipates initial clinical data in the second half of 2027. |
| · | Upcoming ADA presentation highlights Century’s islet cell replacement therapy engineered with Allo-Evasion™ 5.0: Century
will deliver an oral presentation at the ADA 86th Scientific Sessions titled “CNTY-813:
Scalable Production of Allo-Evasion™ 5.0-Engineered
iPSC Beta Islets for Off-the-Shelf
Cell Therapies” (Oral Presentation 1318-OR; Monday, June 8, 2026),
highlighting scalable production of iPSC-derived islets with robust endocrine function and the demonstrated ability to evade the host
immune system. |
| · | CNTY-308 to progress through IND-enabling studies with clinical
trial planned to initiate in 2026: Century remains on track to complete IND-enabling
activities for CNTY-308 and initiate clinical testing in 2026, pending
regulatory clearance. CNTY-308 is a CD19-targeted
CD4⁺/CD8⁺
αβ CAR-iT cell therapy engineered with Allo-Evasion™
5.0 for B-cell-mediated
diseases. Previously presented 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. |
Corporate
| · | As previously disclosed,
completed oversubscribed $135 million private placement financing in January 2026
(HERE for more details). |
First Quarter 2026 Financial Results
| · | Cash Position: Cash, cash equivalents, and marketable securities were $217.0 million as of March 31, 2026, as
compared to $117.1 million as of December 31, 2025. Net cash used in operations was $25.3 million for the quarter ended March 31,
2026, compared to net cash used in operations of $34.6 million for the quarter ended March 31, 2025. The company estimates its cash,
cash equivalents, and investments as of March 31, 2026 will support operations into the first quarter of 2029. |
| · | Research and Development (R&D) Expenses: R&D expenses were $17.1 million for the quarter ended March 31,
2026, compared to $26.6 million for the same period in 2025. The decrease was primarily the result of a reduction in personnel and lower
clinical trial spending. |
| · | General and Administrative (G&A) Expenses: G&A expenses were $6.6 million for quarter ended March 31,
2026, compared to $8.4 million for the same period in 2025. |
| · | Net Income (Loss): Net (loss) was $21.6 million for the quarter ended March 31, 2026, compared to net income of $76.6 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 diseases, including type 1 diabetes, and cancer. The company’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 our timing and expectations regarding our preclinical 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, preclinical 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 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 most recent filings 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 Balance Sheets
(unaudited, in thousands)
| | |
March 31, | | |
December 31, | |
| Assets | |
2026 | | |
2025 | |
| Current Assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 51,048 | | |
$ | 61,853 | |
| Short-term investments | |
| 83,755 | | |
| 55,261 | |
| Prepaid expenses and other current assets | |
| 4,236 | | |
| 3,655 | |
| Total current assets | |
| 139,039 | | |
| 120,769 | |
| Property and equipment, net | |
| 47,606 | | |
| 50,026 | |
| Operating lease right-of-use assets | |
| 20,972 | | |
| 16,139 | |
| Long-term investments | |
| 82,169 | | |
| - | |
| Intangible assets | |
| 34,200 | | |
| 34,200 | |
| Other long-term assets | |
| 2,567 | | |
| 2,570 | |
| Total assets | |
$ | 326,553 | | |
$ | 223,704 | |
| | |
| | | |
| | |
| Liabilities, convertible preferred stock, and stockholders' equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 3,150 | | |
$ | 4,773 | |
| Accrued expenses and other liabilities | |
| 8,477 | | |
| 11,696 | |
| Contingent consideration liability, short term | |
| 1,939 | | |
| 3,757 | |
| Total current liabilities | |
| 13,566 | | |
| 20,226 | |
| Operating lease liability, long-term | |
| 43,942 | | |
| 40,241 | |
| Deferred tax liability | |
| 4,301 | | |
| 4,301 | |
| Total liabilities | |
| 61,809 | | |
| 64,768 | |
| Stockholders' equity | |
| | | |
| | |
| Common stock | |
| 18 | | |
| 9 | |
| Additional paid-in capital | |
| 1,078,873 | | |
| 950,814 | |
| Accumulated deficit | |
| (813,562 | ) | |
| (791,917 | ) |
| Accumulated other comprehensive income | |
| (585 | ) | |
| 30 | |
| Total stockholders' equity | |
| 264,744 | | |
| 158,936 | |
| Total liabilities and stockholders' equity | |
$ | 326,553 | | |
$ | 223,704 | |
Century Therapeutics, Inc
Condensed consolidated statements of operations
(unaudited, in thousands, except share and per share amounts)
| | |
Three Months Ended | | |
Three Months Ended | |
| | |
March 31, 2026 | | |
March 31, 2025 | |
| Collaboration Revenue | |
$ | - | | |
$ | 109,164 | |
| | |
| | | |
| | |
| Operating Expenses | |
| | | |
| | |
| Research and development | |
| 17,105 | | |
| 26,580 | |
| General and administrative | |
| 6,579 | | |
| 8,408 | |
| Total operating expenses | |
| 23,684 | | |
| 34,988 | |
| | |
| | | |
| | |
| Income (loss) from operations | |
| (23,684 | ) | |
| 74,176 | |
| | |
| | | |
| | |
| Interest income | |
| 2,019 | | |
| 2,422 | |
| Other income (loss) | |
| 20 | | |
| (38 | ) |
| Total other income | |
| 2,039 | | |
| 2,384 | |
| | |
| | | |
| | |
| Net income (loss) | |
$ | (21,645 | ) | |
$ | 76,560 | |
| | |
| | | |
| | |
| Unrealized loss on investments | |
| (615 | ) | |
| (19 | ) |
| Comprehensive income (loss) | |
$ | (22,260 | ) | |
$ | 76,541 | |
| | |
| | | |
| | |
Net income (loss) per common share
Basic and Diluted | |
| (0.11 | ) | |
| 0.89 | |
| | |
| | | |
| | |
Weighted average common shares outstanding
Basic | |
| 193,474,913 | | |
| 86,021,188 | |
Weighted average common shares outstanding
Diluted | |
| 193,474,913 | | |
| 86,098,619 | |
