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Century Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates - Expansion of Phase 1 CALiPSO-1 trial of CNTY-101 in autoimmune disease to include diffuse cutaneous systemic sclerosis and

Key Takeaway: Century Therapeutics reported its third quarter financial results and highlighted significant advancements in its clinical trials. The company is expanding its Phase 1 CALiPSO-1 trial of CNTY-101 to include additional autoimmune diseases, which is expected to provide insights into its therapeutic potential. In its Phase 1 ELiPSE-1 trial, CNTY-101 demonstrated a high overall response rate and favorable safety profile for patients with r/r B-cell lymphomas. Century aims to advance its pipeline and has secured a robust cash runway, extending into the second half of 2026.

Market Sentiment Analysis

POSITIVE FACTORS

  • Expansion of Phase 1 CALiPSO-1 trial to include new indications.
  • High overall response rate of 83% observed in Phase 1 ELiPSE-1 trial.
  • Strong financial position with $244.7 million in cash and equivalents.
  • Ongoing development of promising iPSC-derived therapies.

Full Press Release Details

Century Therapeutics Reports Third Quarter 2024
Financial Results and Provides Business Updates
- Expansion of Phase 1 CALiPSO-1
trial of CNTY-101 in autoimmune disease to include diffuse cutaneous systemic sclerosis and idiopathic inflammatory myopathy -
- Overall response rate (ORR)
of 83% observed at CNTY-101 Dose Level 3B alongside a favorable safety profile in patients with r/r B-cell lymphomas in Phase 1 ELiPSE-1
CNTY-101 shows persistence upon repeated cell dosing at Dose Level 3B, consistent with the anticipated protective activity of Century's
proprietary Allo-Evasion technology -
- Ended third quarter 2024 with cash, cash equivalents, and investments
of $244.7 million; organizational efficiencies extend expected cash runway into second half of 2026 -
PHILADELPHIA, November 5, 2024 -- Century Therapeutics, Inc.
("Century", NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent
stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune disease, today reported financial results and business
highlights for the third quarter ended September 30, 2024.
our strategic focus in autoimmune indications to include idiopathic inflammatory myopathy and diffuse cutaneous systemic sclerosis will
give us greater insight into the potential of CNTY-101 in an underserved therapeutic category that we believe is uniquely suited to allogeneic
iNK cell therapies. Our confidence in the application of CNTY-101 in autoimmune diseases continues to be reinforced by the Phase 1 ELiPSE-1
trial in patients with r/r B-cell lymphomas where updated interim data shows increased overall response rates at higher doses and observations
of deepening responses with additional cycles, alongside a continued favorable safety profile," said Brent Pfeiffenberger, Pharm.D.,
Chief Executive Officer of Century Therapeutics. "The advancement of our pre-clinical pipeline across multiple cell types is similarly
promising, as highlighted by what we believe to be the industry-first presentation of iPSC-derived CD4+ and CD8+ CAR T cells that
demonstrate -like T cell function at the upcoming American Society of Hematology Annual Meeting. Building on this progress,
we are conducting a strategic review of Century's pre-clinical pipeline and expect to announce the outcome in the first quarter
of 2025. We have recently refined our organizational structure to enhance ongoing efficiencies and program alignment. On behalf of everyone
here at Century, I'd like to thank departing colleagues for their important contributions to building the company's programs
and technology. Supported by extended cash runway from these changes, we remain focused on execution in the period ahead and look forward
to delivering our next set of potential catalysts."
Research & Development Highlights
A dose-dependent increase in CNTY-101 exposure was observed
as evaluated by a novel pharmacokinetics cell-free DNA (cfDNA) method for detecting total body presence of CNTY-101. Preliminary cfDNA
data from Schedule B (three weekly CNTY-101 infusions per cycle) showed that in cycles starting with lymphodepletion, a similar level
of exposure was observed between the first and third infusion when the patients' endogenous T and NK cells had recovered. This supports
persistence upon repeated cell dosing, consistent with the anticipated protective activity of Century's proprietary Allo-Evasion
Efficient B-cell depletion was observed in all participants
treated with CNTY-101 who had measurable circulating B cells at baseline. Evaluable re-emergent B cells (N=4 participants) were enriched
for naive subtypes with minimal class-switched memory subsets detected. This profile in re-emergent B cells has been associated with SLE
responses after CD19 cell therapy treatment, which we believe further supports application of CNTY-101 in the CALiPSO-1 study. Based on
favorable safety and encouraging early efficacy data at DL3B, Century is proceeding with DL4B (3 billion cells in each of three weekly
doses per cycle), and recently treated the first participant at this dose. The company expects to provide updated clinical data by mid-2025.
Further details pertaining to the ELiPSE-1 data update can
be found in Century's corporate presentation housed on the investor relations section of the website.
Third Quarter 2024 Financial Results
About Century Therapeutics
Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune
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
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 disease care. For more information on Century Therapeutics, please visit www.centurytx.com.
About Idiopathic Inflammatory Myopathy
Idiopathic inflammatory myopathies (IIM) include a heterogenous group
of rare disorders including dermatomyositis and polymyositis in which the immune system attacks muscle and frequently the lungs, skin,
joints, and gastrointestinal tract. IIM can cause weakness, pain, and lung failure which can lead to chronic disability and potentially
mortality. With a prevalence of at least 60,000 people in the US, significant unmet need in IIM stems from the limited efficacy of current
therapies, as corticosteroids and immunosuppressants often fail to halt disease progression. Additionally, these treatments carry significant
side effects, including increased infection risk and long-term complications. A lack of targeted therapies and reliable biomarkers for
early diagnosis complicates disease management and underscores the urgent need for better treatment options and personalized care approaches.
Systemic sclerosis (SSc), a type of scleroderma, is a chronic autoimmune
disease characterized by inflammation and hardening with tightening of the skin and internal organs such as the lungs, heart, and gut,
leading to life-threatening complications. Over half of people with SSc develop lung fibrosis, a leading cause of death. SSc, which affects
at least 80,000 people in the US, typically appears between the ages of 30 and 50. A third of this patient population has diffuse cutaneous
systemic sclerosis, the most severe and rapidly progressing disease subtype. There is no cure for SSc, and current therapies focus
on managing symptoms and slowing disease progression. Medications like immunosuppressants, vasodilators, and antifibrotic agents may help,
but often come with significant side effects. Furthermore, treatment response varies between people, and organ damage may be irreversible
by the time of diagnosis, making early detection and intervention crucial.
Century Therapeutics Forward-Looking Statement
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 the initial safety and efficacy profiles of CNTY-101 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 and our ability
to progress CNTY-101 through our CALiPSO and ELiPSE Phase 1 clinical trials; our ability to meet development milestones on anticipated
timelines; 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; 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

Frequently Asked Questions

What is CNTY-101's response rate in ongoing trials?

CNTY-101 has shown an overall response rate of 83% at Dose Level 3B.

What diseases are included in the CALiPSO-1 trial?

The CALiPSO-1 trial includes idiopathic inflammatory myopathy and systemic sclerosis.

What financial position did Century Therapeutics report?

As of Q3 2024, Century Therapeutics reported $244.7 million in cash and investments.

When will updated clinical data for CNTY-101 be available?

Updated clinical data for CNTY-101 is expected by mid-2025.

What therapeutic areas is Century focusing on?

Century is focusing on immuno-oncology and autoimmune diseases with its therapies.

Last updated: Nov 5, 2024