Century Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Updates
August 11 2022 - 7:30AM
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 second quarter
ended June 30, 2022.
“We are excited about our recent IND submission for our lead
candidate, CNTY-101, and pending FDA clearance, are looking forward
to initiating the Phase 1 ELiPSE-1 trial in relapsed/refractory
lymphoma,” said Lalo Flores, Chief Executive Officer, Century
Therapeutics. “We continue to make steady progress in building a
best-in-class allogeneic cell therapy platform and achieved a key
milestone this quarter in establishing the iNK 3.0 Common
Progenitor, which we believe will accelerate new candidate
selection. Additionally, we look forward to providing updates on
our gamma delta iT platform and other program advancements in the
coming months.”
Business Highlights
- The Company
presented preclinical data on MAD7, a novel CRISPR nuclease
used to enable the genetic engineering of iPSC-derived NK and T
cell product candidates, during a poster presentation at the
American Society of Gene and Cell Therapy (ASGCT) 25th Annual
Meeting held on May 16-19, 2022 in Washington, D.C. A copy of the
presentation is available in the Posters section of Century’s
website.
- During a Research and Development
Event in June, Century’s management team discussed CNTY-103, the
Company’s first solid tumor candidate for glioblastoma, the
establishment of the Common Progenitor iNK 3.0, and progress on the
Company’s next-generation iPSC-based cell therapy platform. Century
expects to submit an Investigational New Drug (IND) application for
CNTY-103 in 2024.
- The Company’s current Good
Manufacturing Practice (cGMP) manufacturing facility in Branchburg,
New Jersey is operational and undergoing qualification.
- Century was added to the Russell
Microcap Index in June 2022.
Subsequent Events and Upcoming Milestones
- Following the recent submission of
the IND application for CNTY-101, the Company remains on track to
initiate its Phase 1 ELiPSE-1 clinical trial in the second half of
2022, subject to U.S. Food and Drug Administration (FDA) clearance
of the application. ELiPSE-1 will assess CNTY-101 in patients with
relapsed/refractory CD19 positive aggressive lymphoma or indolent
lymphoma after at least two prior lines of therapy, including
patients who have received prior CAR-T cell therapy.
Second Quarter 2022 Financial Results
- Cash
Position: Cash, cash equivalents, and investments
were $429.4 million as of June 30, 2022, as compared to $358.8
million as of December 31, 2021. Net cash provided by operations
was $61.2 million for the six months ended June 30, 2022 (which
includes deferred revenue from the Bristol-Myers Squibb (BMS)
collaboration of $120.7M) compared to net cash used in operations
of $40.7 million for the six months ended June 30, 2021.
- Collaboration
Revenue: Collaboration revenue was $1.4 million for the
three months ended June 30, 2022, generated through the Company’s
collaboration, option and license agreement with BMS.
- Research and Development
(R&D) expenses: R&D expenses were $24.5 million
for the three months ended June 30, 2022, compared to $18.9 million
for the same period in 2021. The increase in R&D expenses was
primarily due to an increase in personnel expenses related to
increased headcount to expand the Company’s R&D capabilities,
costs for pre-clinical studies, costs for laboratory supplies and
facility costs, offset by a decrease in collaboration expenses with
FUJIFILM Cellular Dynamics, Inc. (FCDI) as the scope of work with
FCDI has narrowed down to primarily manufacturing CNTY-101 clinical
supply.
- General and Administrative
(G&A) expenses: G&A expenses were $8.3 million for
the three months ended June 30, 2022, compared to $4.1 million for
the same period in 2021. The increase was primarily due to an
increase in employee headcount, an increase in directors’ and
officers’ insurance expense and an increase in the Company’s
professional fees as a result of expanded operations to support the
Company’s infrastructure as well as additional costs to operate as
a public company, and increased information technology and facility
costs.
- Net loss: Net loss
was $31.0 million for the three months ended June 30, 2022,
compared to $23.3 million for the same period in 2021.
Financial Guidance
- The Company expects full year GAAP
Operating Expenses to be between $155 million and $165 million
including non-cash stock-based compensation expense of $10 million
to $15 million.
- The Company expects its cash, cash
equivalents, and investments will support operations into
2025.
About Century Therapeutics
Century Therapeutics, Inc. (NASDAQ: IPSC) is harnessing the
power of adult stem cells to develop curative cell therapy products
for cancer 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. 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 care. For more information on Century Therapeutics please
visit https://www.centurytx.com/.
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
regarding our cash, financial resources, and estimated expenses,
our clinical development plans and timelines, and the development
of our U.S. manufacturing facility 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 presentation 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 obtain FDA acceptance for our 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 COVID-19
pandemic, geopolitical issues 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 future 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; 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:
Company: Elizabeth Krutoholow –
investor.relations@centurytx.com
Investors: Melissa Forst/Maghan Meyers –
century@argotpartners.com
Media: Joshua R. Mansbach – century@argotpartners.com
|
Century Therapeutics, Inc |
Condensed Balance Sheets |
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
Assets |
|
|
2022 |
|
|
2021 |
Current Assets: |
|
$ |
|
|
$ |
|
Cash and cash equivalents |
|
|
112,787 |
|
|
|
56,445 |
|
Short-term investments |
|
|
265,971 |
|
|
|
166,434 |
|
Prepaid expenses and other current assets |
|
5,035 |
|
|
|
5,275 |
|
Total current assets |
|
|
383,793 |
|
|
|
228,154 |
|
Property and equipment, net |
|
|
69,971 |
|
|
|
57,967 |
|
Operating lease right-of-use assets, net |
|
|
24,728 |
|
|
|
11,854 |
|
Long-term investments |
|
|
50,607 |
|
|
|
135,914 |
|
Other long-term assets |
|
|
3,485 |
|
|
|
3,486 |
|
Total assets |
|
$ |
532,584 |
|
|
$ |
437,375 |
|
|
|
|
|
|
|
|
Liabilities, convertible preferred stock, and stockholders'
equity |
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,048 |
|
|
$ |
7,596 |
|
Accrued expenses and other liabilities |
|
|
9,697 |
|
|
|
8,059 |
|
Deferred revenue, current |
|
|
7,824 |
|
|
|
- |
|
Total current liabilities |
|
|
21,569 |
|
|
|
15,655 |
|
Operating lease liability, noncurrent |
|
|
30,433 |
|
|
|
14,559 |
|
Long-term debt, net |
|
|
8,501 |
|
|
|
8,903 |
|
Other long-term liabilities |
|
|
1,220 |
|
|
|
2,020 |
|
Deferred revenue |
|
|
112,909 |
|
|
|
- |
|
Total liabilities |
|
|
174,632 |
|
|
|
41,137 |
|
Stockholders' equity |
|
|
|
|
|
|
Common stock |
|
|
6 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
818,047 |
|
|
|
785,049 |
|
Accumulated deficit |
|
|
(456,667 |
) |
|
|
(388,166 |
) |
Accumulated other comprehensive loss |
|
|
(3,434 |
) |
|
|
(650 |
) |
Total stockholders' equity |
|
|
357,952 |
|
|
|
396,238 |
|
Total liabilities and stockholders' equity |
|
$ |
532,584 |
|
|
$ |
437,375 |
|
|
|
|
|
|
|
|
Century Therapeutics, Inc |
Condensed consolidated statements of
operations |
(unaudited, in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration Revenue |
$ |
1,396 |
|
|
$ |
- |
|
|
$ |
2,454 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
24,494 |
|
|
$ |
18,933 |
|
|
$ |
45,690 |
|
|
$ |
34,307 |
|
General and administrative |
|
8,253 |
|
|
|
4,088 |
|
|
|
15,551 |
|
|
|
6,776 |
|
In-process research and development |
|
- |
|
|
|
- |
|
|
|
10,000 |
|
|
|
- |
|
Total operating expenses |
$ |
32,747 |
|
|
$ |
23,021 |
|
|
$ |
71,241 |
|
|
$ |
41,083 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(31,351 |
) |
|
|
(23,021 |
) |
|
|
(68,787 |
) |
|
|
(41,083 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(330 |
) |
|
|
(318 |
) |
|
|
(644 |
) |
|
|
(632 |
) |
Other income, net |
|
711 |
|
|
|
66 |
|
|
|
964 |
|
|
|
94 |
|
Loss before provision for income taxes |
$ |
(30,970 |
) |
|
$ |
(23,273 |
) |
|
$ |
(68,467 |
) |
|
$ |
(41,621 |
) |
Provision for income taxes |
|
(18 |
) |
|
|
- |
|
|
|
(34 |
) |
|
|
- |
|
Net Loss |
$ |
(30,988 |
) |
|
$ |
(23,273 |
) |
|
$ |
(68,501 |
) |
|
$ |
(41,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on investments |
|
(780 |
) |
|
|
32 |
|
|
|
(2,766 |
) |
|
|
5 |
|
Foreign currency translation adjustment |
|
(12 |
) |
|
|
(9 |
) |
|
|
(18 |
) |
|
|
(5 |
) |
Comprehensive loss |
|
(31,780 |
) |
|
|
(23,250 |
) |
|
|
(71,285 |
) |
|
|
(41,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - Basic and Diluted |
|
(0.54 |
) |
|
|
(1.93 |
) |
|
|
(1.19 |
) |
|
|
(4.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
57,685,006 |
|
|
|
12,044,610 |
|
|
|
57,370,022 |
|
|
|
9,775,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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