Century Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates
August 08 2024 - 7:30AM
Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative
biotechnology company developing induced pluripotent stem cell
(iPSC)-derived cell therapies in immuno-oncology and autoimmune
disease, today reported financial results and business highlights
for the second quarter ended June 30, 2024.
“Our strategic autoimmune expansion, as highlighted by the
recent initiation of the CALiPSO-1 trial in Systemic Lupus
Erythematosus and addition of a Lupus Nephritis-specific cohort,
positions Century as a potential leader in allogeneic cell
therapies for autoimmune diseases. 2024 remains a time of focused
execution as we work to advance our next-generation allogeneic
iPSC-derived cell therapy platform and pipeline, equipped with our
proprietary Allo-Evasion™ technology, capturing a diversified
opportunity to address a broad range of indications with high unmet
need. I am proud of the significant progress we have achieved in
such a short period of time, particularly underscored by the
evolution of our platform and capabilities, which we anticipate
will enable our iPSC candidates to have a more controlled, durable,
and tolerable profile,” said Brent Pfeiffenberger, Pharm.D., Chief
Executive Officer of Century Therapeutics. “We remain focused on
progressing CNTY-101 in both of our clinical-stage programs,
including advancement into dose expansion in the ELiPSE-1 trial in
patients with r/r B-cell lymphomas and acceleration of patient
enrollment following the recent initiation of the CALiPSO-1 trial.
We’ve made strides in our initial execution of autoimmune expansion
as evidenced by our CALiPSO-1 trial updates, while simultaneously
pursuing additional regulatory filings for CNTY-101 in other
autoimmune disease indications in the second half of the year. We
look forward to continued execution and the opportunity to deliver
on our next set of potential catalysts, including the expectation
of initial clinical data from CALiPSO-1 by
year-end.”
Research & Development Highlights
- Consistent with Century’s
autoimmune disease expansion efforts announced in April 2024, the
Company recently initiated the Phase 1 CALiPSO-1 trial of CNTY-101
(NCT06255028) in Systemic Lupus Erythematosus (SLE). The first
clinical trial site has been activated, with additional sites
continuing to open across the United States. The Company expects
initial clinical data from CALiPSO-1 by year-end 2024. Furthermore,
Century recently amended the protocol to include a new
indication-specific cohort of Lupus Nephritis (LN) patients.
CALiPSO-1 is an open-label multi-center clinical trial to evaluate
the safety, tolerability, pharmacokinetics, and clinical response
of CNTY-101 in patients with moderate to severe SLE and LN who have
failed at least two standard immunosuppressive therapies. The
inclusion of LN patients highlights Century’s execution in pursuing
additional regulatory filings as a way of accelerating and
broadening its research and development initiatives in autoimmune
diseases. The Company intends to submit additional regulatory
filings for CNTY-101 in autoimmune disease indications with limited
current treatment options and high unmet need in the second half of
2024.
- In May 2024,
Century presented two posters at the American Society of Gene and
Cell Therapy (ASGCT) Annual Meeting showcasing the potential
ability of its lead program, CNTY-101, a CD19 targeting allogeneic
iNK cell therapy with 6 precision gene edits powered by Century’s
Allo-Evasion™ technology, to treat B-Cell driven autoimmune
diseases including SLE, and new preclinical data demonstrating the
potential utility of using a novel synthetic ligand targeting
CD300a as a universal strategy for preventing natural killer (NK)
cell mediated rejection in allogeneic cell therapies. The Company
believes that these capabilities demonstrate the potential
protection of allogeneic cell therapies with the possibility for
improved outcomes, while delivering a broadly beneficial treatment
option across a range of indications.
- In June 2024, the Company presented
encouraging interim efficacy and safety data from the ongoing Phase
1 ELiPSE-1, multicenter, open-label clinical trial of CNTY-101
(NCT05336409) in heavily pre-treated patients with R/R
CD19-positive B-cell lymphomas at the American Society of Clinical
Oncology (ASCO) Annual Meeting. Evaluable preliminary safety (n=12)
and efficacy (n=10) as of the data cutoff date of March 27, 2024,
from the ongoing dose escalation portion of the trial, demonstrated
a manageable tolerability profile with no observed dose limiting
toxicities (DLT) or graft-versus-host disease (GvHD). After rapidly
trafficking out of circulation, pharmacokinetics (PK), evaluated by
a novel cell-free DNA method, showed that CNTY-101 persistence
outside the bloodstream trended with increases in dose. Data also
showed additional responses across escalating doses and different
types of B-cell malignancies in heavily pretreated patients with
predominantly aggressive or high-risk histologies.
- The Company recently completed dose
escalation of schedule A (single dose per cycle) and schedule B (3
doses per cycle) in the ELiPSE-1 trial and is currently enrolling
patients in the dose confirmation portion. Progression into dose
expansion is expected in the second half of 2024.
Corporate Highlights
- In April 2024, the Company completed
a private placement of common stock with gross proceeds of $60
million with new and existing investors. Also in April 2024, the
Company closed the acquisition of Clade Therapeutics, bringing
enhancement of its Allo-Evasion™ platform and adding three
preclinical stage αβ iT programs spanning across cancer and
autoimmune diseases to its pipeline.
Second Quarter 2024 Financial Results
- Cash
Position: Cash, cash equivalents, and marketable
securities were $269.6 million as of June 30, 2024, as compared to
$261.8 million as of December 31, 2023. Net cash used in operations
was $57.6 million for the six months ended June 30, 2024, compared
to net cash used in operations of $48.5 million for the six months
ended June 30, 2023.
- Collaboration
Revenue: Collaboration revenue generated through the
Company’s collaboration, option, and license agreement with
Bristol-Myers Squibb was $0.8 million for the three months ended
June 30, 2024, compared to $0.1 million for the same period in
2023.
- Research and Development
(R&D) expenses: R&D expenses were $27.2 million
for the three months ended June 30, 2024, compared to $22.7 million
for the same period in 2023. The increase in R&D expenses was
primarily due to increased manufacturing activity for CNTY-101 and
the acquisition of Clade Therapeutics.
- General and Administrative
(G&A) expenses: G&A expenses were $8.3 million for
the three months ended June 30, 2024, compared to $8.2 million for
the same period in 2023.
- Net loss: Net loss
was $31.2 million for the three months ended June 30, 2024,
compared to $33.3 million for the three months ended June 30,
2023.
Financial Guidance
- The Company expects full year
generally accepted accounting principles (GAAP) operating expenses
to be between $150 million and $160 million.
- The Company estimates 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 diseases that we believe will allow us to
overcome the limitations of first-generation cell therapies. Our
genetically engineered, iPSC-derived cell product candidates are
designed to specifically target hematologic and solid tumor
cancers, with a broadening application to 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 cancer and
autoimmune disease care. 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 and the
initial safety and efficacy profiles of CNTY-101 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; the ability of CNTY-101 to be administered as
part of a multi-dose strategy and to enable responses without
lymphodepletion; 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; the timing of and our ability to
successfully enroll the Phase 1 SLE and LN trial; the timing of and
our ability to enter dose expansion of the Phase 1 R/R
CD19-positive B-cell lymphomas trial; our ability to obtain FDA
clearance of our future IND 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, 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:
Investor Relations & Media Contacts
Century Therapeutics
Katja Buhrer
SVP, Head of Corporate Affairs and Strategy
katja.buhrer@centurytx.com
917-969-3438
Argot Partners
Julie Seidel/Noor Pahlavi
century@argotpartners.com
212-600-1902
Century Therapeutics, Inc |
Condensed Balance Sheets |
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
Assets |
|
|
2024 |
|
|
2023 |
Current Assets: |
|
$ |
|
|
$ |
|
Cash and cash equivalents |
|
|
41,457 |
|
|
|
47,324 |
|
Short-term investments |
|
|
154,945 |
|
|
|
125,414 |
|
Prepaid expenses and other current assets |
|
|
7,076 |
|
|
|
4,256 |
|
Total current assets |
|
|
203,478 |
|
|
|
176,994 |
|
Property and equipment, net |
|
|
69,405 |
|
|
|
71,705 |
|
Operating lease right-of-use assets, net |
|
|
28,570 |
|
|
|
20,376 |
|
Long-term investments |
|
|
73,226 |
|
|
|
89,096 |
|
Goodwill |
|
|
5,091 |
|
|
|
- |
|
Intangible assets |
|
|
33,300 |
|
|
|
- |
|
Other long-term assets |
|
|
3,376 |
|
|
|
2,520 |
|
Total assets |
|
$ |
416,446 |
|
|
$ |
360,691 |
|
|
|
|
|
|
|
|
Liabilities, convertible preferred stock, and stockholders'
equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,358 |
|
|
$ |
2,741 |
|
Accrued expenses and other liabilities |
|
|
11,445 |
|
|
|
10,733 |
|
Long-term debt, current |
|
|
- |
|
|
|
- |
|
Deferred revenue, current |
|
|
4,360 |
|
|
|
4,372 |
|
Total current liabilities |
|
|
19,163 |
|
|
|
17,846 |
|
Operating lease liability, noncurrent |
|
|
52,713 |
|
|
|
46,658 |
|
Other long-term liabilities |
|
|
3,386 |
|
|
|
56 |
|
Deferred revenue |
|
|
109,768 |
|
|
|
111,381 |
|
Contingent consideration liability |
|
|
9,312 |
|
|
|
- |
|
Total liabilities |
|
|
194,342 |
|
|
|
175,941 |
|
Stockholders' equity |
|
|
|
|
|
|
Common stock |
|
|
8 |
|
|
|
6 |
|
Additional paid-in capital |
|
|
937,445 |
|
|
|
840,407 |
|
Accumulated deficit |
|
|
(715,040 |
) |
|
|
(655,771 |
) |
Accumulated other comprehensive loss |
|
|
(309 |
) |
|
|
108 |
|
Total stockholders' equity |
|
|
222,104 |
|
|
|
184,750 |
|
Total liabilities and stockholders' equity |
|
$ |
416,446 |
|
|
$ |
360,691 |
|
Century Therapeutics, Inc |
Condensed consolidated statements of
operations |
(unaudited, in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Three Months Ended |
|
Six Months Ended |
|
Six Months Ended |
|
June 30, 2024 |
|
June 30, 2023 |
|
June 30, 2024 |
|
June 30, 2023 |
Collaboration Revenue |
$ |
771 |
|
|
$ |
99 |
|
|
$ |
1,625 |
|
|
$ |
1,819 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
27,220 |
|
|
|
22,727 |
|
|
|
50,641 |
|
|
|
47,626 |
|
General and administrative |
|
8,306 |
|
|
|
8,229 |
|
|
|
17,052 |
|
|
|
17,131 |
|
Impairment on long-lived assets |
|
- |
|
|
|
4,220 |
|
|
|
- |
|
|
|
4,220 |
|
Total operating expenses |
|
35,526 |
|
|
|
35,176 |
|
|
|
67,693 |
|
|
|
68,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(34,755 |
) |
|
|
(35,077 |
) |
|
|
(66,068 |
) |
|
|
(67,158 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
- |
|
|
|
(136 |
) |
|
|
- |
|
|
|
(540 |
) |
Interest income |
|
3,582 |
|
|
|
3,058 |
|
|
|
6,820 |
|
|
|
5,681 |
|
Other income, net |
|
(12 |
) |
|
|
(186 |
) |
|
|
1 |
|
|
|
(380 |
) |
Loss before provision for income taxes |
|
(31,185 |
) |
|
|
(32,341 |
) |
|
|
(59,247 |
) |
|
|
(62,397 |
) |
Provision for income taxes |
|
(22 |
) |
|
|
(950 |
) |
|
|
(22 |
) |
|
|
(2,158 |
) |
Net Loss |
$ |
(31,207 |
) |
|
$ |
(33,291 |
) |
|
$ |
(59,269 |
) |
|
$ |
(64,555 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on investments |
|
(102 |
) |
|
|
59 |
|
|
|
(453 |
) |
|
|
1,255 |
|
Foreign currency translation adjustment gain (loss) |
|
35 |
|
|
|
9 |
|
|
|
36 |
|
|
|
- |
|
Comprehensive loss |
$ |
(31,274 |
) |
|
$ |
(33,223 |
) |
|
$ |
(59,686 |
) |
|
$ |
(63,300 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - Basic and Diluted |
|
(0.38 |
) |
|
|
(0.56 |
) |
|
|
0.82 |
|
|
|
(1.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
82,092,167 |
|
|
|
59,251,363 |
|
|
|
72,194,402 |
|
|
|
58,904,726 |
|
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