Century Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update

   -- Preclinical pipeline re-prioritization to focus on four potentially 
      transformative programs to advance toward clinic, led by CNTY-308 in 
      B-cell mediated autoimmune diseases and malignancies 
   -- New concentrated clinical focus for CNTY-101 based on unique profile with 
      transformational potential in autoimmune disease; data anticipated in 
      2025 
   -- Cash runway estimate extended into fourth quarter of 2026 

PHILADELPHIA, March 19, 2025 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. ('Century', NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in autoimmune disease and cancer, today reported financial results and business highlights for the full year 2024.

"Today we announced a pipeline re-prioritization to streamline resources on advancing candidates that are potentially transformational or best-in-class in diseases with high unmet need. We ended the year with a strong cash position, which we will leverage to achieve meaningful milestones and drive value for all stakeholders as we take the company forward in a new direction," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. "We have made the strategic decision to discontinue the Phase 1 ELiPSE-1 trial early, and we thank the patients, providers and caregivers for their support and participation. We believe CNTY-101 is well-positioned to potentially impact the standard of care meaningfully in B-cell-mediated autoimmune diseases. We are implementing key initiatives to drive toward delivering data in 2025 from the CALiPSO-1 Phase 1 trial, including new site activations and enhanced patient enrollment efforts in both the U.S. and EU, and with further insights from the CARAMEL Phase 1 investigator-initiated clinical trial which is expected to initiate in mid-2025."

Fourth Quarter 2024 and Recent Highlights

Clinical Pipeline for CNTY-101

   -- Phase 1 CALiPSO-1 trial site expansion in United States and Europe: The 
      first patient in our CALiPSO-1 Phase 1 trial in autoimmune diseases is 
      enrolled and scheduled for dosing in March 2025. Five sites in the U.S. 
      are actively screening patients and Century has increased resourcing for 
      trial site activation and proficient recruitment. The company is also 
      expanding the CALiPSO-1 clinical trial to include additional sites in 
      select European countries and expects enrollment at those sites will 
      initiate in the second half of 2025. 
   -- CARAMEL IIT on track to commence in mid-2025 following CTA approval: In 
      January 2025, the company announced it had entered into an agreement for 
      an investigator-initiated (IIT) Phase 1/2 trial by Professors Georg 
      Schett and Andreas Mackensen of its CD19 CAR-iNK investigational cell 
      therapy candidate CNTY-101 in patients with B-cell mediated autoimmune 
      diseases. The IIT, which is sponsored by the Friedrich-Alexander 
      University Erlangen-Nürnberg, represents the first evaluation by the 
      internationally recognized Schett/Mackensen group of an allogeneic 
      iPSC-derived CD19-directed NK cell therapy for the treatment of 
      autoimmune diseases. The CARAMEL trial is expected to commence in 
      mid-2025 following Clinical Trial Authorization $(CTA.UK)$ approval. 
   -- Early discontinuation of ELiPSE-1 program in late-stage R/R NHL: While 
      the company remains encouraged by the clinical activity and tolerability 
      profile of CNTY-101 in late-stage relapsed-refractory non-Hodgkin's 
      lymphoma (R/R NHL), the emerging clinical data do not meet the company's 
      threshold to be considered transformational in this patient population 
      and the program is being discontinued. The company is committed to 
      providing continued treatment access in the ELiPSE-1 trial for patients 
      showing benefit. We believe the ELiPSE-1 data continues to reinforce the 
      potential of CNTY-101 in autoimmune diseases: in addition to encouraging 
      clinical activity in a difficult to treat R/R NHL population and a 
      favorable tolerability profile, translational data also showed evidence 
      of CNTY-101 trafficking to lymph nodes and deep B cell depletion 
      following treatment. The ELiPSE-1 data continues to support 
      proof-of-concept for Allo-Evasion$(TM)$ and the ability to enable repeat 
      dosing of the company's cell therapies. Further data is expected to be 
      presented in 2025. 

Preclinical Pipeline

"We look forward to our planned webinar next month where we will dive deeper into the programs we are taking forward. We believe these exciting programs unlock an opportunity to replace current therapies and expand application of cell therapy to areas with serious medical need, starting with what we believe to be our unique ab CD4+/CD8+ CAR-T cells combined with our most advanced Allo-Evasion(TM) 5.0 technology," said Chad Cowan, Ph.D., Chief Scientific Officer of Century Therapeutics. "In the case of CNTY-308 and CNTY-341 in B-cell-mediated diseases, we are aiming for comparable or better performance to approved autologous CAR-T therapies. With our combined expertise in protein engineering, cell differentiation, and manufacturing, we aim to launch allogeneic cell therapies at antibody-like scale and cost. For our solid tumor and non-immune cell programs, this brings the potential to expand access to cell therapies much more broadly."

   -- Announced pipeline re-prioritization and live webcast on April 22nd: 
      Today the company announced four new prioritized programs anchored by 
      advanced iPSC-derived 'tunable' CD4+/CD8+ ab T cells with target profiles 
      comparable to autologous CART cells. All four programs are engineered 
      with the company's proprietary immune evasion technology, 
      Allo-Evasion(TM) 5.0, designed to enable holistic evasion of T cell, NK 
      cell, and humoral immunity. Management will host a live webcast on 
      Tuesday, April 22nd to discuss each of the prioritized programs in more 
      detail. 
   -- Advancing CNTY-308 toward product candidate selection: CNTY-308 is a 
      CD19-targeted CAR-iT cell therapy engineered with Allo-Evasion(TM) 5.0 
      which has demonstrated preclinical characteristics comparable to 
      autologous CD19 CAR-T cells, including proliferation on target engagement, 
      cytokine secretion, cytotoxic elimination of tumor cells, persistence and 
      proliferation on rechallenge. CNTY-308 is being developed for B-cell 
      mediated autoimmune diseases and malignancies. The company expects to 
      initiate IND-enabling studies with CNTY-308 in mid-2025. 
   -- Three additional preclinical programs being taken forward based on their 
      profiles: CNTY-341 is a CD19/CD22 dual-targeted CAR-iT cell therapy 
      engineered with Allo-Evasion(TM) 5.0 which pairs dual targeting and 
      primary T-cell-like functionality in an allogeneic cell with the goal of 
      providing a differentiated therapy for B cell malignancies. The next 
      program is the company's first solid tumor CAR iT program exploiting 
      Nectin-4 CAR and other validated targets, engineered 
      with Allo-Evasion(TM) 5.0 and additional engineering aimed at overcoming 
      the key barriers to success in treating solid tumors. In addition, the 
      company is leveraging its expertise in selective iPSC differentiation to 
      non-immune effector cells with opportunities to potentially accelerate in 
      high-impact therapeutic areas where the company believes its technology 
      and capabilities provide meaningful differentiation. 

Full Year 2024 Financial Results

   -- Cash Position: Cash, cash equivalents, and marketable securities were 
      $220.1 million as of December 31, 2024, as compared to $261.8 million as 
      of December 31, 2023. Net cash used in operations was $110.1 million for 
      the year ended December 31, 2024, compared to net cash used in operations 
      of $88.3 million for the year ended December 31, 2023. The company 
      estimates its cash, cash equivalents, and investments will support 
      operations into the fourth quarter of 2026. 
   -- Collaboration Revenue: Collaboration revenue generated through the 
      company's collaboration, option, and license agreement with Bristol-Myers 
      Squibb was $6.6 million. 
   -- Research and Development (R&D) Expenses: R&D expenses were $107.2 million 
      for the year ended December 31, 2024, compared to $92.7 million for the 
      same period in 2023. The increase in R&D expenses is most notably due to 
      increase in research and laboratory costs due to progression of the 
      ELiPSE-1 clinical trial, start-up costs relating to the CALiPSO-1 trial, 
      and manufacturing costs related to the company's collaboration with 
      FujiFilm Cellular Dynamics, Inc. 
   -- General and Administrative (G&A) Expenses: G&A expenses were $33.2 
      million for the year ended December 31, 2024, compared to $34.7 million 
      for the same period in 2023. The decrease was primarily due to a decrease 
      in employee headcount during the 2024 fiscal year. 
   -- Net Loss: Net loss was $126.6 million for the year ended December 31, 
      2024, compared to net loss of $136.7 million for the same period in 2023. 

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 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.

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 dependence on the success of our lead product candidate, CNTY-101; our ability to progress CNTY-101 through clinical development; 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 events, changed circumstances or otherwise.

For More Information:

Century Therapeutics

Morgan Conn, PhD

Chief Financial Officer

investor.relations@centurytx.com

JPA Health

Sarah McCabe

smccabe@jpa.com

 
                     Century Therapeutics, Inc 
                      Condensed Balance Sheets 
                     (unaudited, in thousands) 
 
                                       December 31,    December 31, 
Assets                                     2024            2023 
                                       ------------   -------------- 
Current Assets:                       $              $ 
   Cash and cash equivalents                58,441         47,324 
   Short-term investments                  130,851        125,414 
   Prepaid expenses and other 
    current assets                           4,759          4,256 
                                       -----------    ----------- 
Total current assets                       194,051        176,994 
Property and equipment, net                 62,141         71,705 
Operating lease right-of-use assets, 
 net                                        28,706         20,376 
Long-term investments                       30,818         89,096 
Goodwill                                         -              - 
Intangible assets                           34,200              - 
Other long-term assets                       3,300          2,520 
                                       -----------    ----------- 
Total assets                          $    353,216   $    360,691 
                                       ===========    =========== 
 
Liabilities, convertible preferred 
stock, and stockholders' equity 
Current liabilities: 
   Accounts payable                   $      3,075   $      2,741 
   Accrued expenses and other 
    liabilities                             17,543         10,733 
   Long-term debt, current                       -              - 
   Deferred revenue, current               109,164          4,372 
                                       -----------    ----------- 
Total current liabilities                  129,782         17,846 
Operating lease liability, 
 noncurrent                                 48,960         46,658 
Long-term debt, net                              -              - 
Other long-term liabilities                      -             56 
Deferred revenue                                 -        111,381 
Contingent consideration liability           8,738              - 
Deferred tax liability                       4,374              - 
                                       -----------    ----------- 
Total liabilities                          191,854        175,941 
                                       -----------    ----------- 
Stockholders' equity 
Common stock                                     9              6 
Additional paid-in capital                 943,366        840,407 
Accumulated deficit                       (782,337)      (655,771) 
Accumulated other comprehensive loss           324            108 
                                       -----------    ----------- 
Total stockholders' equity                 161,362        184,750 
                                       -----------    ----------- 
Total liabilities and stockholders' 
 equity                               $    353,216   $    360,691 
                                       ===========    =========== 
 
 
 
                      Century Therapeutics, Inc 
           Condensed consolidated statements of operations 
         (unaudited, in thousands, except share and per share 
                               amounts) 
 
                                  Year Ended           Year Ended 
                               December 31, 2024    December 31, 2023 
                               -----------------   ------------------- 
Collaboration Revenue         $           6,589   $           2,235 
 
Operating Expenses 
   Research and development             107,244              92,710 
   General and 
    administrative                       33,155              34,706 
   In-process research and 
    development                               -               5,000 
   Impairment on long-lived 
    assets                                    -              16,365 
   Impairment of goodwill                 4,327                   - 
                               ----------------    ---------------- 
      Total operating 
       expenses                         144,726             148,781 
                               ----------------    ---------------- 
 
Loss from operations                   (138,137)           (146,546) 
 
Interest expense                              -                $(540.SI)$ 
Interest income                          13,007              12,677 
Other income, net                           354                (383) 

                               ----------------    ---------------- 
Loss before provision for 
 income taxes                          (124,776)           (134,792) 
   Provision for income 
    taxes                                (1,790)             (1,881) 
                               ----------------    ---------------- 
 
Net Loss                      $        (126,566)  $        (136,673) 
                               ================    ================ 
 
   Unrealized gain (loss) on 
    investments                             153               2,602 
   Foreign currency 
    translation adjustment 
    gain (loss)                              63                 (32) 
                               ----------------    ---------------- 
 
Comprehensive loss            $        (126,350)  $        (134,103) 
                               ================    ================ 
 
Net loss per common share - 
 Basic and Diluted                        (1.61)              (2.30) 
                               ================    ================ 
 
Weighted average common 
 shares outstanding                  78,648,958          59,314,389 
                               ================    ================ 
 
 

(END) Dow Jones Newswires

March 19, 2025 16:01 ET (20:01 GMT)