On March 19, 2025 Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in autoimmune disease and cancer, reported financial results and business highlights for the full year 2024 (Press release, Century Therapeutics, MAR 19, 2025, View Source [SID1234651253]).
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"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) 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 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 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 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 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 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 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.