Century Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates
November 09 2023 - 7:01AM
Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative
biotechnology company developing induced pluripotent stem cell
(iPSC)-derived cell therapies in immuno-oncology, today reported
financial results and business highlights for the third quarter
ended September 30, 2023.
“The last several months have been marked by
immense progress for Century, and we are thrilled to welcome Brent
to the team as our new leader at this exciting period in the
Company’s history,” said Joe Jimenez, Chairman of the Board of
Directors of Century. Greg Russotti, Interim Chief Executive
Officer, Century Therapeutics added, “We continued to advance our
Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or
refractory CD19 positive B-cell lymphomas. Building on the exciting
case study featured in our ASH abstract earlier this month, we look
forward to sharing additional data in December which we believe
continue to support the potential for a multi-dosing strategy for
CAR iNK enabled by Allo-Evasion™.”
Dr. Russotti added, “Furthermore, we were
extremely excited to announce this morning that we have expanded
our license agreements with our partners at FCDI. These expanded
agreements provide us new and continued access to technology that
we believe will aid in our mission to bring curative cell therapy
products to patients in need, including patients with autoimmune
and inflammatory diseases.”
Business Highlights and Upcoming
Milestones
- This morning,
Century announced the appointment of Brent Pfeiffenberger,
Pharm.D., MBA, as Chief Executive Officer and member of the Board
of Directors, effective December 4, 2023. He brings to Century over
20 years of broad-ranging global leadership experience across the
healthcare industry, most recently serving as Chief Operating
Officer at Neogene Therapeutics. Also effective December 4, 2023,
Greg Russotti, Ph.D., who has served as Century’s Interim Chief
Executive Officer since April 2023, will assume the role of Chief
Technology and Manufacturing Officer, an expanded role from his
previous position as Chief Technology Officer.
- During a poster
session at the upcoming ASH Annual Meeting being held December 9-12
in San Diego, the Company will present initial data from the
ongoing first-in-human Phase 1 ELiPSE-1 trial of CNTY-101 in
relapsed/refractory CD19 positive B-cell lymphomas. As previously
announced, preliminary clinical data from a case study featured in
the recently published ASH abstract shows a complete response
maintained in a Dose Cohort 1 (100 million cell dose level) patient
with high risk relapsed/refractory follicular lymphoma following
completion of four 28-day cycles of CNTY-101, the two most recent
of which did not include lymphodepletion. Updated data to be
announced in December will include additional results from patients
treated in Dose Cohort 1 as of a more recent cutoff date, as well
as preliminary data from patients in Dose Cohort 2 (300 million
cell dose level).
- This morning,
Century and FUJI Cellular Dynamics (FCDI) announced that they have
entered into a worldwide license agreement whereby FCDI will grant
the Company non-exclusive licenses for certain patent rights and
know-how related to cell differentiation and reprogramming for the
development and commercialization of iPSC-derived therapies for the
treatment of autoimmune and inflammatory diseases. The Company also
shared that it expanded its existing 2018 license agreement with
FCDI related to the development and commercialization of
iPSC-derived cancer immunotherapeutics to also include inflammatory
and autoimmune diseases.
Third Quarter 2023 Financial
Results
- Cash
Position: Cash, cash equivalents, and investments
were $284.3 million as of September 30, 2023, as compared to $367.4
million as of December 31, 2022. Net cash used in operations was
$61.8 million for the nine months ended September 30, 2022 compared
to net cash provided by operations of $37.0 million for the nine
months ended September 30, 2022 (which includes deferred revenue
from the Bristol Myers Squibb (BMS) collaboration of $118.5
million).
-
Collaboration Revenue: Collaboration revenue
generated through the Company’s collaboration, option, and license
agreement with BMS was $0.1 million for the three months ended
September 30, 2023 compared to $2.2 million for the same period in
2022. Revenue recognized under the collaboration agreement
fluctuates based on the amount and timing of expenses incurred
under the agreement.
- Research
and Development (R&D) expenses: R&D expenses were
$22.8 million for the three months ended September 30, 2023
compared to $25.9 million for the same period in 2022. The decrease
in R&D expenses was primarily due to the Company’s 2023
reorganization and reprioritization of early-stage programs and
discovery platforms as well as a decline in sponsored research
activities.
- General
and Administrative (G&A) expenses: G&A expenses
were $9.0 million for the three months ended September 30, 2023,
compared to $8.1 million for the same period in 2022. The increase
was primarily due increases in stock-based compensation and
recruiting fees.
- Net
loss: Net loss was $32.7 million for the three months
ended September 30, 2023, compared to $30.7 million for the same
period in 2022.
Financial Guidance
- The Company
expects full year GAAP Operating Expenses to be between $135
million and $145 million including non-cash stock-based
compensation expense of $12 million to $17 million.
- The Company
expects its cash, cash equivalents, and investments will support
operations into 2026.
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is
harnessing the power of adult stem cells to develop curative cell
therapy products for cancer and autoimmune and inflammatory
diseases that we believe will allow us to overcome the limitations
of first-generation cell therapies. Our genetically engineered,
iPSC-derived iNK and iT cell product candidates are designed to
specifically target hematologic and solid tumor cancers with a
broadening application to inflammatory and autoimmune diseases. We
are leveraging our expertise in cellular reprogramming, genetic
engineering, and manufacturing to develop therapies with the
potential to overcome many of the challenges inherent to cell
therapy and provide a significant advantage over existing cell
therapy technologies. We believe our commitment to developing
off-the-shelf cell therapies will expand patient access and provide
an unparalleled opportunity to advance the course of care for
cancer and autoimmune and inflammatory diseases. For more
information on Century Therapeutics please visit
www.centurytx.com.
Century Therapeutics Forward-Looking
Statement
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 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 obtain FDA acceptance for our
future IND submissions and commence 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 the
effects of the COVID-19 pandemic, geopolitical issues, 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:
Investors and Media: Argot Partners –
century@argotpartners.com
Century
Therapeutics, Inc |
|
Condensed
Balance Sheets |
|
(unaudited,
in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December
31, |
|
Assets |
|
|
2023 |
|
|
2022 |
|
|
Current
Assets: |
|
$ |
|
|
$ |
|
|
|
Cash and cash equivalents |
|
|
55,307 |
|
|
84,265 |
|
|
Short-term investments |
|
|
114,198 |
|
|
231,233 |
|
|
Prepaid expenses and other current assets |
|
4,198 |
|
|
4,223 |
|
|
Total
current assets |
|
|
173,703 |
|
|
319,721 |
|
|
Property and
equipment, net |
|
|
81,993 |
|
|
82,785 |
|
|
Operating
lease right-of-use assets, net |
|
|
24,551 |
|
|
28,945 |
|
|
Long-term
investments |
|
|
114,762 |
|
|
51,854 |
|
|
Other
long-term assets |
|
|
2,542 |
|
|
3,239 |
|
|
Total assets |
|
$ |
397,551 |
|
$ |
486,544 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities, convertible preferred stock, and stockholders'
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
5,927 |
|
$ |
5,454 |
|
|
Accrued expenses and other liabilities |
|
|
10,637 |
|
|
10,707 |
|
|
Long-term debt, current |
|
|
- |
|
|
6,502 |
|
|
Deferred revenue, current |
|
|
3,871 |
|
|
7,154 |
|
|
Total
current liabilities |
|
|
20,435 |
|
|
29,817 |
|
|
Operating
lease liability, noncurrent |
|
|
45,535 |
|
|
38,698 |
|
|
Long-term
debt, net |
|
|
- |
|
|
3,739 |
|
|
Other
long-term liabilities |
|
|
201 |
|
|
718 |
|
|
Deferred
revenue |
|
|
112,150 |
|
|
110,834 |
|
|
Total
liabilities |
|
|
178,321 |
|
|
183,806 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Common
stock |
|
|
6 |
|
|
6 |
|
|
Additional
paid-in capital |
|
|
836,901 |
|
|
824,292 |
|
|
Accumulated
deficit |
|
|
(616,373) |
|
|
(519,098) |
|
|
Accumulated
other comprehensive loss |
|
|
(1,304) |
|
|
(2,462) |
|
|
Total
stockholders' equity |
|
|
219,230 |
|
|
302,738 |
|
|
Total liabilities and stockholders' equity |
|
$ |
397,551 |
|
$ |
486,544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Century
Therapeutics, Inc |
Condensed
consolidated statements of operations |
(unaudited,
in thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months Ended |
|
Nine months Ended |
|
|
|
September
30, |
|
|
September
30, |
|
|
September
30, |
|
|
September
30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Collaboration Revenue |
$ |
148 |
|
|
$ |
2,224 |
|
|
$ |
1,967 |
|
|
$ |
4,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
22,788 |
|
|
$ |
25,898 |
|
|
$ |
70,414 |
|
|
$ |
71,588 |
|
|
General and administrative |
|
8,986 |
|
|
|
8,064 |
|
|
|
26,117 |
|
|
|
23,615 |
|
|
In-process research and development |
|
4,000 |
|
|
|
- |
|
|
|
4,000 |
|
|
|
10,000 |
|
|
Impairment on long-lived assets |
|
- |
|
|
|
- |
|
|
|
4,220 |
|
|
|
- |
|
|
Total operating expenses |
$ |
35,774 |
|
|
$ |
33,962 |
|
|
$ |
104,751 |
|
|
$ |
105,203 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
(35,626 |
) |
|
|
(31,738 |
) |
|
|
(102,784 |
) |
|
|
(100,525 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
- |
|
|
|
(373 |
) |
|
|
(540 |
) |
|
|
(1,017 |
) |
|
Interest
income |
|
3,486 |
|
|
|
1,411 |
|
|
|
9,167 |
|
|
|
2,370 |
|
|
Other
income, net |
|
12 |
|
|
|
(24 |
) |
|
|
(368 |
) |
|
|
(19 |
) |
|
Loss before
provision for income taxes |
$ |
(32,128 |
) |
|
$ |
(30,724 |
) |
|
$ |
(94,525 |
) |
|
$ |
(99,191 |
) |
|
Provision for income taxes |
|
(592 |
) |
|
|
(25 |
) |
|
|
(2,750 |
) |
|
|
(59 |
) |
|
Net
Loss |
$ |
(32,720 |
) |
|
$ |
(30,749 |
) |
|
$ |
(97,275 |
) |
|
$ |
(99,250 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investments |
|
(95 |
) |
|
|
(165 |
) |
|
|
1,157 |
|
|
|
(2,931 |
) |
|
Foreign currency translation adjustment |
|
(2 |
) |
|
|
(5 |
) |
|
|
(1 |
) |
|
|
(23 |
) |
|
Comprehensive loss |
|
(32,817 |
) |
|
|
(30,919 |
) |
|
|
(96,119 |
) |
|
|
(102,204 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share - Basic and Diluted |
|
(0.55 |
) |
|
|
(0.53 |
) |
|
|
(1.65 |
) |
|
|
(1.72 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding |
|
59,448,229 |
|
|
|
57,973,541 |
|
|
|
59,087,374 |
|
|
|
57,573,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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