Full Press Release Details
Century Therapeutics
Reports Third Quarter 2022 Financial Results and Provides Business Updates
Phase 1 ELiPSE-1 trial of CNTY-101 in relapsed/refractory CD19 positive B-cell malignancies expected to begin imminently -
Ended third quarter 2022 with cash, cash equivalents, and investments of $395.3 million; Cash runway into 2025 -
virtual Research and Development Day on Friday, November 11 at 8:00 AM ET -
PHILADELPHIA, November 10, 2022 -- 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,
"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."
Subsequent Events and Upcoming Milestones
Third Quarter 2022 Financial Results
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
Media: Joshua R. Mansbach - century@argotpartners.com
Century Therapeutics, Inc
Condensed Balance Sheets
(unaudited, in thousands)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| 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,
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 |