Century Therapeutics Reports Full Year 2022 Financial Results and Provides Business Updates
March 16 2023 - 7:30AM
Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative
clinical-stage biotechnology company developing induced pluripotent
stem cell (iPSC)-derived cell therapies in immuno-oncology, today
reported financial results and business highlights for the
full-year ended December 31, 2022.
“We are excited about the significant progress of our next
generation platforms for iNK and gamma delta iT product candidates,
including the commencement of our Phase 1 ELiPSE-1 trial for
CNTY-101. We are well-positioned for a productive 2023 as we
continue building on the foundational investments we’ve made in
iPSC technology, genetic editing, and manufacturing,” said Lalo
Flores, Chief Executive Officer, Century Therapeutics. “We have a
strong balance sheet and are realizing platform and operational
efficiencies which we believe extend our cash runway into 2026 and
allow us to deliver on our key platform and program
milestones.”
Business Highlights
- In February 2023, the Company
announced that the first patient has been dosed in the
first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in
relapsed or refractory CD19 positive B-cell lymphomas. As a leading
next-generation allogeneic cell therapy candidate, CNTY-101 is the
first to test the potential of a finite, repeat dosing regimen and
the ability to deliver more durable responses enabled by
Allo-Evasion™ gene edits designed to prevent rejection. Initial
data from Schedule A of the trial is planned to be available by
year-end 2023.
- In January 2023, the Company announced
an internal portfolio prioritization which allows for the
acceleration of key programs including CNTY-107 in Nectin-4+
tumors, and extended the Company’s expected cash runway into
2026.
- The Company has selected targets for
CNTY-102, a CAR-iT product candidate, against CD19 and CD22 for
relapsed/refractory B-cell lymphoma and other B-cell malignancies.
The Company expects to share pre-clinical data later this
year.
- In November 2022, the Company
presented preclinical data in two posters at the Society for
Immunotherapy of Cancer 37th Annual Meeting. The data presented
supported the Company’s next generation platform for iPSC-derived
NK cells and demonstrated that iPSC-derived CAR gamma delta T cells
effectively control solid tumors as monotherapy and in combination
with a therapeutic antibody. The Company also hosted a virtual
Research and Development Day, where the Company announced the
nomination of the next pipeline program, CNTY-107.
Full Year 2022 Financial Results
- Cash
Position: Cash, cash equivalents, and marketable
securities were $367.4 million as of December 31, 2022, as compared
to $358.8 million as of December 31, 2021. Net cash provided by
operations was $14.1 million for the twelve months ended December
31, 2022 (which includes deferred revenues from the Bristol-Myers
Squibb (BMS) collaboration of $118.0 million), compared to net cash
used in operations of $89.0 million for the twelve months ended
December 31, 2021.
- Collaboration
Revenue: Collaboration revenue was $5.2 million for the
twelve months ended December 31, 2022, generated through the
Company’s collaboration, option and license agreement with
BMS.
- Research and Development
(R&D) expenses: R&D expenses were $97.2 million
for the year ended December 31, 2022, compared to $75.6 million for
the year ended December 31, 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 preclinical studies and clinical expenses for advancing
CNTY-101, costs for laboratory supplies, and facility costs.
- General and Administrative
(G&A) expenses: G&A expenses were $31.9 million
for the year ended December 31, 2022, compared to $19.2 million for
the year ended December 31, 2021. The increase in G&A expenses
was primarily due to an increase in employee headcount and
additional costs to operate as a public company.
- Net loss: Net loss
was $130.9 million for the year ended December 31, 2022, compared
to $95.8 million for the year ended December 31, 2021.
Financial Guidance
- The Company expects full year
generally accepted accounting principles (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 estimates its cash, cash
equivalents, and investments will support operations into
2026.
About Century Therapeutics
Century Therapeutics, Inc. (NASDAQ: IPSC) is a clinical-stage
biotechnology company 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 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 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 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/Media: Melissa Forst/Maghan Meyers –
century@argotpartners.com
Century Therapeutics, Inc |
|
Condensed Balance Sheets |
|
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
Assets |
|
|
2022 |
|
|
2021 |
Current Assets: |
|
$ |
|
|
$ |
|
Cash and cash equivalents |
|
|
84,265 |
|
|
56,445 |
Short-term investments |
|
|
231,233 |
|
|
166,434 |
Prepaid expenses and other current assets |
|
4,223 |
|
|
5,275 |
Total current assets |
|
|
319,721 |
|
|
228,154 |
Property and equipment, net |
|
|
82,785 |
|
|
57,967 |
Operating lease right-of-use assets, net |
|
|
28,945 |
|
|
11,854 |
Long-term investments |
|
|
51,854 |
|
|
135,914 |
Other long-term assets |
|
|
3,239 |
|
|
3,486 |
Total assets |
|
$ |
486,544 |
|
$ |
437,375 |
|
|
|
|
|
|
|
Liabilities, convertible preferred stock, and stockholders'
equity |
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,454 |
|
$ |
7,596 |
Accrued expenses and other liabilities |
|
|
10,707 |
|
|
7,020 |
Long-term debt, current |
|
|
6,502 |
|
|
1,039 |
Deferred revenue, current |
|
|
7,154 |
|
|
- |
Total current liabilities |
|
|
29,817 |
|
|
15,655 |
Operating lease liability, noncurrent |
|
|
38,698 |
|
|
14,559 |
Long-term debt, net |
|
|
3,739 |
|
|
8,903 |
Other long-term liabilities |
|
|
718 |
|
|
2,020 |
Deferred revenue |
|
|
110,834 |
|
|
- |
Total liabilities |
|
|
183,806 |
|
|
41,137 |
Stockholders' equity |
|
|
|
|
|
|
Common stock |
|
|
6 |
|
|
5 |
Additional paid-in capital |
|
|
824,292 |
|
|
785,049 |
Accumulated deficit |
|
|
(519,098) |
|
|
(388,166) |
Accumulated other comprehensive loss |
|
|
(2,462) |
|
|
(650) |
Total stockholders' equity |
|
|
302,738 |
|
|
396,238 |
Total liabilities and stockholders' equity |
|
$ |
486,544 |
|
$ |
437,375 |
Century Therapeutics, Inc |
Condensed consolidated statements of
operations |
(unaudited, in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
December 31, |
|
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Collaboration Revenue |
$ |
5,199 |
|
|
$ |
- |
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Research and development |
$ |
97,173 |
|
|
$ |
75,648 |
|
General and administrative |
|
31,857 |
|
|
|
19,235 |
|
In-process research and development |
|
10,000 |
|
|
|
- |
|
Total operating expenses |
$ |
139,030 |
|
|
$ |
94,883 |
|
|
|
|
|
|
|
Loss from operations |
|
(133,831 |
) |
|
|
(94,883 |
) |
|
|
|
|
|
|
Interest expense |
|
(1,430 |
) |
|
|
(1,275 |
) |
Other income, net |
|
4,420 |
|
|
|
377 |
|
Loss before provision for income taxes |
$ |
(130,841 |
) |
|
$ |
(95,781 |
) |
Provision for income taxes |
|
(91 |
) |
|
|
(43 |
) |
Net Loss |
$ |
(130,932 |
) |
|
$ |
(95,824 |
) |
|
|
|
|
|
|
Unrealized loss on investments |
|
(1,786 |
) |
|
|
(615 |
) |
Foreign currency translation adjustment |
|
(26 |
) |
|
|
(32 |
) |
Comprehensive loss |
|
(132,744 |
) |
|
|
(96,471 |
) |
|
|
|
|
|
|
Net loss per common share - Basic and Diluted |
|
(2.27 |
) |
|
|
(2.96 |
) |
|
|
|
|
|
|
Weighted average common shares outstanding |
|
57,755,842 |
|
|
|
32,392,554 |
|
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