Century Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
May 15 2025 - 4:01PM
Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), an innovative
biotechnology company developing induced pluripotent stem cell
(iPSC)-derived cell therapies in autoimmune disease and cancer,
today reported financial results and business highlights for the
first quarter ended March 31, 2025.
“We have made important progress focusing on pipeline programs
with transformational potential in high-value commercial markets.
In a recently held company webinar and at ASGCT, we showcased
developmental progress with our preclinical pipeline, iPSC
platform, and manufacturing capabilities, highlighting the
potential for a pathway to developing iPSC-derived cell therapies
at antibody-like scale. We are on track to initiate IND-enabling
studies for our lead preclinical program, CNTY-308, in mid-2025,”
said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of
Century Therapeutics. “For our clinical-stage pipeline, patient
dosing is now underway in the U.S. for the CALiPSO-1 trial and,
with expansion into Europe, we remain on track to deliver clinical
data for CNTY-101 by the end of 2025. We look forward to building
on this momentum and pursuing a disciplined approach across our
pipeline to bring investigational cell therapies closer to patients
and generate value for all our stakeholders.”
First Quarter 2025 and Recent Highlights
CNTY-101 in Autoimmune Disease
- Patient dosing underway in CALiPSO-1 trial in the
U.S.: In March 2025, the first patient was dosed in the
Phase 1 CALiPSO-1 trial which is currently evaluating CNTY-101 as a
potential treatment for patients with B-cell-mediated autoimmune
diseases.
- Focus on CALiPSO-1 clinical trial expansion and patient
recruitment: Five clinical trial sites in the U.S. are
active with additional U.S. clinical trial sites expected to open
in 2025. Site activation activities are underway in select European
countries, with enrollment at these sites expected to initiate in
the second half of 2025. The company’s Clinical Trial Application
(CTA) has been authorized in Germany, France, and Italy, providing
important external validation of Century’s approach to clinical
studies with allogeneic iPSC-derived therapies.
- CARAMEL IIT CTA authorized and study on track to
commence in mid-2025: The CARAMEL investigator-initiated
trial (IIT), a Phase 1/2 trial of CNTY-101 in patients with
B-cell-mediated autoimmune diseases led by Professors Georg Schett
and Andreas Mackensen and sponsored by the Friedrich-Alexander
University Erlangen-Nürnberg, is expected to commence in mid-2025.
The CTA has been authorized in Germany
- Clinical data by end of 2025: The company
remains on track to report clinical data for CNTY-101 by the end of
2025.
CNTY-308 and Other Preclinical Programs
- ASGCT presentations highlighting preclinical
pipeline: At the ongoing American Society of Gene and Cell
Therapy (ASGCT) 28th Annual Meeting, the company is presenting data
on the company’s emerging preclinical cell therapy pipeline for
autoimmune diseases and cancer. The data from the poster
presentation suggest certain engineering modifications to CAR-iT
and CAR-iNK cells can improve the anti-tumor activity of
iPSC-derived immunotherapies to withstand the immunosuppressive
nature of the solid tumor microenvironment. The data from the oral
presentation characterize the generation of allogeneic iPSC-derived
targeted CD4+/CD8+ ab CAR-T cells with comparable function, in vivo
proliferation, and tumor control to primary T cells, supporting
their use for the development of scalable, accessible CAR-T cell
therapies.
- CNTY-308 on track to enter into IND-enabling studies in
mid-2025: The company continues to expect to initiate
Investigational New Drug (IND)-enabling studies with CNTY-308, a
CD19-targeted CD4+/CD8+ ab CAR-iT cell therapy engineered with
Allo-Evasion™ 5.0 as a potential treatment for B-cell-mediated
autoimmune diseases and malignancies, in mid-2025.
- Progressing early-stage development activities for
iPSC-derived ab CAR-T cells in
oncology and opportunities with non-immune effector cells in
high-impact diseases: The company is advancing CNTY-341, a
CD19/CD22 dual-targeted CAR-iT investigational cell therapy
intended for B-cell malignancies, and the company’s first solid
tumor CAR-iT investigational program exploiting nectin-4 CAR and
other validated targets. Each of these programs is anchored by
advanced iPSC-derived ’tunable’ CD4+/CD8+ ab T cells and is
engineered with the company’s proprietary immune evasion
technology, Allo-Evasion™ 5.0, which is designed to enable holistic
evasion of T cell, NK cell, and humoral immunity. In addition, the
company is leveraging its deep expertise in selective iPSC
differentiation to non-immune effector cells with opportunities to
potentially accelerate in high-impact therapeutic areas where the
company believes its technology and capabilities provide meaningful
differentiation.
First Quarter 2025 Financial Results
- Cash Position: Cash, cash equivalents, and
marketable securities were $185.8 million as of March 31, 2025, as
compared to $220.1 million as of December 31, 2024. The company
estimates its cash, cash equivalents, and investments will support
operations into the fourth quarter of 2026.
- Collaboration Revenue: Collaboration revenue
generated through the company’s collaboration, option, and license
agreement with Bristol-Myers Squibb (the Collaboration Agreement)
was $109.2 million for the three months ended March 31, 2025,
compared to $0.9 million for the same period in 2024. The
Collaboration Agreement was terminated effective March 12, 2025. As
such, the company recognized $109.2 million of collaboration
revenue for the quarter ended March 31, 2025. There will be no
future collaboration revenues recognized under the Collaboration
Agreement.
- Research and Development (R&D) Expenses:
R&D expenses were $26.6 million for the three months ended
March 31, 2025, compared to $23.4 million for the same period in
2024. The increase in R&D expenses is most notably due to
increased clinical trial costs and advancing of preclinical
programs.
- General and Administrative (G&A) Expenses:
G&A expenses were $8.4 million for the three months ended March
31, 2025, compared to $8.7 million for the same period in 2024. The
decrease was primarily due to a decrease in salary and benefit
expense.
- Net Income (Loss): Net income was $76.6
million for the three months ended March 31, 2025, compared to net
(loss) of $28.1 million for the same period in 2024.
About Century TherapeuticsCentury Therapeutics
(NASDAQ: IPSC) is a clinical-stage biotechnology company leveraging
its expertise in cellular reprogramming, genetic engineering, and
manufacturing to develop cell therapies with the potential to
provide meaningful advantages over existing cell therapies.
Century’s genetically engineered, iPSC-derived cell therapy
pipeline includes programs designed to address autoimmune diseases
and cancers. Century believes its commitment to developing
off-the-shelf cell therapies will expand patient access and provide
an opportunity to advance the course of autoimmune disease and
cancer care. For more information on Century Therapeutics, please
visit www.centurytx.com and connect with us on
LinkedIn.
Forward-Looking StatementsThis 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 regarding our clinical
development plans and timelines 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 dependence on the success of our lead product
candidate, CNTY-101; our ability to progress CNTY-101 through
clinical development; 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 TherapeuticsMorgan Conn, Ph.D.Chief Financial Officer
investor.relations@centurytx.com
JPA HealthSarah McCabesmccabe@jpa.com
Century Therapeutics, Inc |
Condensed Balance Sheets |
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
Assets |
|
2025 |
|
2024 |
Current Assets: |
|
$ |
|
|
$ |
|
Cash and cash equivalents |
|
|
51,865 |
|
|
|
58,441 |
|
Short-term investments |
|
|
113,256 |
|
|
|
130,851 |
|
Prepaid expenses and other current assets |
|
|
4,510 |
|
|
|
4,759 |
|
Total current assets |
|
|
169,631 |
|
|
|
194,051 |
|
Property and equipment, net |
|
|
59,532 |
|
|
|
62,141 |
|
Operating lease right-of-use assets, net |
|
|
28,232 |
|
|
|
28,706 |
|
Long-term investments |
|
|
20,713 |
|
|
|
30,818 |
|
Intangible assets |
|
|
34,200 |
|
|
|
34,200 |
|
Other long-term assets |
|
|
3,301 |
|
|
|
3,300 |
|
Total assets |
|
$ |
315,609 |
|
|
$ |
353,216 |
|
|
|
|
|
|
|
|
Liabilities, convertible preferred stock, and stockholders'
equity |
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,573 |
|
|
$ |
3,075 |
|
Accrued expenses and other liabilities |
|
|
10,930 |
|
|
|
17,543 |
|
Deferred revenue, current |
|
|
- |
|
|
|
109,164 |
|
Total current liabilities |
|
|
14,503 |
|
|
|
129,782 |
|
Operating lease liability, noncurrent |
|
|
47,793 |
|
|
|
48,960 |
|
Contingent consideration liability |
|
|
8,500 |
|
|
|
8,738 |
|
Deferred tax liability |
|
|
4,374 |
|
|
|
4,374 |
|
Total liabilities |
|
|
75,170 |
|
|
|
191,854 |
|
Stockholders' equity |
|
|
|
|
|
|
Common stock |
|
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
|
945,902 |
|
|
|
943,366 |
|
Accumulated deficit |
|
|
(705,777 |
) |
|
|
(782,337 |
) |
Accumulated other comprehensive loss |
|
|
305 |
|
|
|
324 |
|
Total stockholders' equity |
|
|
240,439 |
|
|
|
161,362 |
|
Total liabilities and stockholders' equity |
|
$ |
315,609 |
|
|
$ |
353,216 |
|
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, 2025 |
|
March 31, 2024 |
Collaboration Revenue |
$ |
109,164 |
|
|
$ |
855 |
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Research and development |
|
26,580 |
|
|
|
23,421 |
|
General and administrative |
|
8,408 |
|
|
|
8,743 |
|
Total operating expenses |
|
34,988 |
|
|
|
32,164 |
|
|
|
|
|
|
|
Income (loss) from operations |
|
74,176 |
|
|
|
(31,309 |
) |
|
|
|
|
|
|
Interest income |
|
2,422 |
|
|
|
3,237 |
|
Other income (expense), net |
|
(38 |
) |
|
|
11 |
|
Income (loss) before provision for income taxes |
|
76,560 |
|
|
|
(28,061 |
) |
Provision for income taxes |
|
- |
|
|
|
(1 |
) |
Net Income (loss) |
$ |
76,560 |
|
|
$ |
(28,062 |
) |
|
|
|
|
|
|
Unrealized loss on investments |
|
(19 |
) |
|
|
(351 |
) |
Foreign currency translation gain |
|
- |
|
|
|
2 |
|
Comprehensive income (loss) |
$ |
76,541 |
|
|
$ |
(28,411 |
) |
|
|
|
|
|
|
Net
income (loss) per common share: Basic |
|
0.89 |
|
|
|
(0.45 |
) |
Net
income (loss) per common share: Diluted |
|
0.89 |
|
|
|
(0.45 |
) |
|
|
|
|
|
|
Weighted average common shares outstanding: Basic |
|
86,021,188 |
|
|
|
62,296,637 |
|
Weighted average common shares outstanding: Diluted |
|
86,098,619 |
|
|
|
62,296,637 |
|
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