Full Press Release Details
Century Therapeutics Reports Full Year 2023
Financial Results and Provides Business Updates
- Presented initial data from Phase 1 ELiPSE-1
Trial of CNTY-101 in relapsed/refractory B-cell lymphomas demonstrating a favorable tolerability profile, early clinical activity and
indication that Allo-Evasion may support a multi-dosing regimen without the need for continued lymphodepletion -
- Received investigational new drug (IND) clearance
for CNTY-101 for the treatment of systemic lupus erythematosus (SLE); On track to initiate Phase 1 CALiPSO-1 clinical trial in the first
- Six posters to be presented at upcoming AACR
Annual Meeting 2024 highlighting Century's end-to-end cell therapy capabilities including expertise across iPSC reprogramming,
gene editing, protein engineering, Allo-Evasion technology and computational biology -
cash, cash equivalents, and investments of $261.8 million; Cash runway into 2026 -
PHILADELPHIA, March 14, 2024 -- Century
Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived
cell therapies in immuno-oncology and autoimmune and inflammatory disease, today reported financial results and business highlights for
the full year ended December 31, 2023.
"We enter 2024 following a series
of significant milestones, highlighted by our presentation at ASH showcasing promising initial data from our ELiPSE-1 trial of CNTY-101.
These findings not only revealed encouraging tolerability and early response signals in treating r/r B-cell lymphomas, but also unveiled
the potential for a multi-dosing strategy while avoiding the need for continued lymphodepletion," said Brent Pfeiffenberger, Pharm.D.,
Chief Executive Officer of Century Therapeutics. "The early success of our Allo-EvasionTM technology, demonstrated by
the recent ELiPSE-1 data, bolsters our confidence in the potential of this approach for prolonged and tighter control over drug exposure
as we anticipate expansion into autoimmune indications, marked by the recent IND clearance of CNTY-101 in SLE. We believe Century remains
at the forefront of pioneering allogeneic cell therapy technology, exemplified by the early clinical activity of CNTY-101 in the ELiPSE-1
trial, the first clinical cell therapy candidate to be engineered with six precision gene edits for enhanced selectivity and persistence,
and continued progress across our discovery and pipeline programs leveraging our integrated capabilities."
Research and Development Highlights and Upcoming Milestones
CNTY-101 is an investigational off-the-shelf immunotherapy product
candidate that utilizes iPSC-derived natural killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and includes Century's
core Allo-Evasion edits designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells
and NK cells. In addition, the product candidate is engineered to express IL-15 to provide homeostatic cytokine support, which has been
in Century's preclinical studies to improve functionality and persistence. Further, to potentially improve safety, the iNK cells
were engineered with an EGFR safety switch, and proof-of-concept studies have demonstrated that the cells can be quickly eliminated by
the administration of cetuximab, an antibody against EGFR approved by the U.S. Food and Drug Administration (FDA) for certain cancers.
Full Year 2023 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 and autoimmune and inflammatory 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 and inflammatory 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 and inflammatory disease care. For more information on Century Therapeutics please visit
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 and financial guidance, 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 initiate and successfully enroll the Phase 1 SLE 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:
Investors and media: Julie Seidel/ Noor Pahlavi - century@argotpartners.com
Century Therapeutics, Inc
Condensed Balance Sheets
(unaudited, in thousands)
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 47,324 | $ | 84,265 | ||||
| Short-term investments | 125,414 | 231,233 | ||||||
| Prepaid expenses and other current assets | 4,256 | 4,223 | ||||||
| Total current assets | 176,994 | 319,721 | ||||||
| Property and equipment, net | 71,705 | 82,785 | ||||||
| Operating lease right-of-use assets, net | 20,376 | 28,945 | ||||||
| Long-term investments | 89,096 | 51,854 | ||||||
| Other long-term assets | 2,520 | 3,239 | ||||||
| Total assets | $ | 360,691 | $ | 486,544 | ||||
| Liabilities, convertible preferred stock, and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,741 | $ | 5,454 | ||||
| Accrued expenses and other liabilities | 10,733 | 10,707 | ||||||
| Long-term debt, current | - | 6,502 | ||||||
| Deferred revenue, current | 4,372 | 7,154 | ||||||
| Total current liabilities | 17,846 | 29,817 | ||||||
| Operating lease liability, noncurrent | 46,658 | 38,698 | ||||||
| Long-term debt, net | - | 3,739 | ||||||
| Other long-term liabilities | 56 | 718 | ||||||
| Deferred revenue | 111,381 | 110,834 | ||||||
| Total liabilities | 175,941 | 183,806 | ||||||
| Stockholders' equity | ||||||||
| Common stock | 6 | 6 | ||||||
| Additional paid-in capital | 840,407 | 824,292 | ||||||
| Accumulated deficit | (655,771 | ) | (519,098 | ) | ||||
| Accumulated other comprehensive loss | 108 | (2,462 | ) | |||||
| Total stockholders' equity | 184,750 | 302,738 | ||||||
| Total liabilities and stockholders' equity | $ | 360,691 | $ | 486,544 |
Condensed consolidated
statements of operations
(unaudited, in thousand,
except share and per share amounts)
| Nine months Ended | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Collaboration Revenue | $ | 2,235 | $ | 5,199 | ||||
| Operating Expenses | ||||||||
| Research and development | $ | 92,710 | $ | 97,173 | ||||
| General and administrative | 34,706 | 31,857 | ||||||
| In-process research and development | 5,000 | 10,000 | ||||||
| Impairment on long-lived assets | 16,365 | - | ||||||
| Total operating expenses | $ | 148,781 | $ | 139,030 | ||||
| Loss from operations | (146,546 | ) | (133,831 | ) | ||||
| Interest expense | (540 | ) | (1,430 | ) | ||||
| Interest income | 12,677 | 4,420 | ||||||
| Other income, net | (383 | ) | - | |||||
| Loss before provision for income taxes | $ | (134,792 | ) | $ | (130,841 | ) | ||
| Provision for income taxes | (1,881 | ) | (91 | ) | ||||
| Net Loss | $ | (136,673 | ) | $ | (130,932 | ) | ||
| Unrealized gain (loss) on investments | 2,602 | (1,786 | ) | |||||
| Foreign currency translation adjustment (loss) | (32 | ) | (26 | ) | ||||
| Comprehensive loss | (134,103 | ) | (132,744 | ) | ||||
| Net loss per common share - Basic and Diluted | (2.30 | ) | (2.27 | ) | ||||
| Weighted average common shares outstanding | 59,314,389 | 57,755,842 |