Century Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Updates
November 10 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 third quarter
ended September 30, 2022.
“We made steady progress this quarter with our next generation
platform and robust portfolio of cell therapy product candidates,
including FDA clearance of our first IND for CNTY-101 in
relapsed/refractory B-cell malignancies,” said Lalo Flores, Chief
Executive Officer, Century Therapeutics. “We are focused on
initiating the Phase 1 ELiPSE-1 trial to assess the potential of
our Allo-EvasionTM edits, designed to prevent immunological
rejection and enhance persistence of multiple dosing regimens of
CNTY-101 with the aim to increase the proportion of patients that
achieve durable responses. We look forward to sharing meaningful
preclinical data updates at the SITC meeting this week on both our
iNK and gamma delta iT cell platforms, and to discussing our
pipeline progress and our solid tumor strategy at our virtual
Research and Development Day tomorrow.”
“As we continue to realize efficiencies in our platform and
synergies across our pipeline, we are updating our financial
guidance for the year by reducing our expected GAAP Operating
Expenses to $140 million and $145 for the full year ended 2022,”
said Michael Diem, Chief Business Officer, Century Therapeutics.
“We will remain fiscally responsible as we continue to execute and
deliver on our platforms, programs and key milestones, leaving us
well positioned with cash runway into 2025.”
Business Highlights
- Following notification from the U.S.
Food and Drug Administration (FDA) that the Phase 1 ELiPSE-1 study
of the Company’s first clinical product candidate, CNTY-101, may
proceed, Century expects to initiate the trial imminently. The
Phase 1 study is designed to assess the safety, tolerability,
pharmacokinetics and preliminary efficacy of CNTY-101 in patients
with relapsed or refractory CD19 positive B-cell malignancies. All
patients will receive an initial standard dose of conditioning
chemotherapy consisting of cyclophosphamide (300 mg/m2) and
fludarabine (30mg/m2) for three days. Schedule A of the trial
includes a single-dose escalation of CNTY-101 and subcutaneous
IL-2. Schedule B will evaluate a three-dose schedule per cycle of
CNTY-101. Patients who demonstrate a clinical benefit are eligible
for additional cycles of treatment with or without additional
lymphodepletion pending FDA consent.
- In October 2022, the Company announced the appointment of
Daphne Quimi and Timothy Walbert to its Board of Directors. Ms.
Quimi is currently Chief Financial Officer of Amicus Therapeutics
and brings operational experience in public accounting and
financial reporting to Century. Mr. Walbert is currently Chairman,
President, and Chief Executive Officer of Horizon Therapeutics, and
brings expertise in product portfolio building and
commercialization.
Subsequent Events and Upcoming Milestones
- Century plans to present preclinical data from its iPSC-based
cell therapy platform in two posters at the Society for
Immunotherapy of Cancer (SITC) 37th Annual Meeting today, November
10, 2022, and tomorrow, Friday, November 11, 2022. A copy of the
presentations will be made available in the Posters section of
Century’s website.
- The Company will host a virtual Research and Development
(R&D) Day on Friday, November 11, 2022, from 8:00 AM to 9:30 AM
ET. The R&D Day will feature presentations from the Company’s
management team and Jonathan Rosenberg, M.D., Chief of the
Genitourinary Oncology Service at the Memorial Sloan Kettering
Cancer Center (MSKCC), Physician at Memorial Hospital at MSKCC, and
Professor of Medicine at Weill Cornell Medical College. The event
will focus on the Company’s gamma delta iT cell platform and solid
tumor strategy and include a discussion of preclinical data to be
presented at the SITC Annual Meeting. For additional information on
how to access the event, please visit the Events &
Presentations section of Century’s website.
Third Quarter 2022 Financial Results
- Cash
Position: Cash, cash equivalents, and investments
were $395.3 million as of September 30, 2022, as compared to $358.8
million as of December 31, 2021. Net cash provided by operations
was $36.9 million for the nine months ended September 30, 2022
(which includes deferred revenue from the Bristol-Myers Squibb
(BMS) collaboration of $118.5 million) compared to net cash used in
operations of $64.7 million for the nine months ended September 30,
2021.
- Collaboration
Revenue: Collaboration revenue was $2.2 million for the
three months ended September 30, 2022, generated through the
Company’s collaboration, option and license agreement with
BMS.
- Research and Development
(R&D) expenses: R&D expenses were $25.9 million
for the three months ended September 30, 2022, compared to $19.5
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 $8.1 million for
the three months ended September 30, 2022, compared to $6.3 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 $30.7 million for the three months ended September 30, 2022,
compared to $26.0 million for the same period in 2021.
Financial Guidance
- The Company expects full
year generally accepted accounting principles (GAAP) operating
expenses to be between $140 million and $145 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 (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
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 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: Melissa Forst/Maghan Meyers –
century@argotpartners.com
Media: Joshua R. Mansbach – century@argotpartners.com
Century Therapeutics, Inc |
Condensed Balance Sheets |
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
Assets |
|
|
2022 |
|
|
2021 |
Current Assets: |
|
$ |
|
|
$ |
|
Cash and cash equivalents |
|
|
111,350 |
|
|
|
56,445 |
|
Short-term investments |
|
|
244,509 |
|
|
|
166,434 |
|
Prepaid expenses and other current assets |
|
5,782 |
|
|
|
5,275 |
|
Total current assets |
|
|
361,641 |
|
|
|
228,154 |
|
Property and equipment, net |
|
|
77,938 |
|
|
|
57,967 |
|
Operating lease right-of-use assets, net |
|
|
29,488 |
|
|
|
11,854 |
|
Long-term investments |
|
|
39,427 |
|
|
|
135,914 |
|
Other long-term assets |
|
|
3,257 |
|
|
|
3,486 |
|
Total assets |
|
$ |
511,751 |
|
|
$ |
437,375 |
|
|
|
|
|
|
|
|
Liabilities, convertible preferred stock, and stockholders'
equity |
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,685 |
|
|
$ |
7,596 |
|
Accrued expenses and other liabilities |
|
|
9,615 |
|
|
|
7,020 |
|
Long-term debt, current |
|
|
4,036 |
|
|
|
1,039 |
|
Deferred revenue, current |
|
|
7,571 |
|
|
|
- |
|
Total current liabilities |
|
|
26,907 |
|
|
|
15,655 |
|
Operating lease liability, noncurrent |
|
|
36,594 |
|
|
|
14,559 |
|
Long-term debt, net |
|
|
6,136 |
|
|
|
8,903 |
|
Other long-term liabilities |
|
|
971 |
|
|
|
2,020 |
|
Deferred revenue |
|
|
110,938 |
|
|
|
- |
|
Total liabilities |
|
|
181,546 |
|
|
|
41,137 |
|
Stockholders' equity |
|
|
|
|
|
|
Common stock |
|
|
6 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
821,219 |
|
|
|
785,049 |
|
Accumulated deficit |
|
|
(487,416 |
) |
|
|
(388,166 |
) |
Accumulated other comprehensive loss |
|
|
(3,604 |
) |
|
|
(650 |
) |
Total stockholders' equity |
|
|
330,205 |
|
|
|
396,238 |
|
Total liabilities and stockholders' equity |
|
$ |
511,751 |
|
|
$ |
437,375 |
|
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, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Collaboration Revenue |
$ |
2,224 |
|
|
$ |
- |
|
|
$ |
4,678 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
25,898 |
|
|
$ |
19,545 |
|
|
$ |
71,588 |
|
|
$ |
53,852 |
|
|
General and administrative |
|
8,064 |
|
|
|
6,282 |
|
|
|
23,615 |
|
|
|
13,058 |
|
|
In-process research and development |
|
- |
|
|
|
- |
|
|
|
10,000 |
|
|
|
- |
|
|
Total operating expenses |
$ |
33,962 |
|
|
$ |
25,827 |
|
|
$ |
105,203 |
|
|
$ |
66,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(31,738 |
) |
|
|
(25,827 |
) |
|
|
(100,525 |
) |
|
|
(66,910 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(373 |
) |
|
|
(322 |
) |
|
|
(1,017 |
) |
|
|
(954 |
) |
|
Other income, net |
|
1,387 |
|
|
|
140 |
|
|
|
2,351 |
|
|
|
234 |
|
|
Loss before provision for income taxes |
$ |
(30,724 |
) |
|
$ |
(26,009 |
) |
|
$ |
(99,191 |
) |
|
$ |
(67,630 |
) |
|
Provision for income taxes |
|
(25 |
) |
|
|
- |
|
|
|
(59 |
) |
|
|
|
|
Net Loss |
$ |
(30,749 |
) |
|
$ |
(26,009 |
) |
|
$ |
(99,250 |
) |
|
$ |
(67,630 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investments |
|
(165 |
) |
|
|
(33 |
) |
|
|
(2,931 |
) |
|
|
(28 |
) |
|
Foreign currency translation adjustment |
|
(5 |
) |
|
|
(27 |
) |
|
|
(23 |
) |
|
|
(32 |
) |
|
Comprehensive loss |
|
(30,919 |
) |
|
|
(26,069 |
) |
|
|
(102,204 |
) |
|
|
(67,690 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - Basic and Diluted |
|
(0.53 |
) |
|
|
(0.48 |
) |
|
|
(1.72 |
) |
|
|
(2.72 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
57,973,541 |
|
|
|
54,472,650 |
|
|
|
57,573,406 |
|
|
|
24,838,250 |
|
|
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