Century Therapeutics(IPSC) - 2025 Q1 - Quarterly Results

Company Overview and Strategy Century Therapeutics focuses on iPSC-derived cell therapies, prioritizing CNTY-101 for autoimmune disorders and advancing its preclinical pipeline with a cash runway into late 2026 Strategic Focus and Financial Position Century Therapeutics is concentrating its clinical efforts on CNTY-101 for autoimmune disorders, leveraging its unique iPSC-derived cell therapy platform. The company is advancing an enhanced preclinical pipeline featuring Allo-Evasion™ 5.0 technology and has secured a cash runway into the fourth quarter of 2026 to support key development milestones, including expected clinical data for CNTY-101 in 2025 - The company is concentrating its clinical focus on CNTY-101 for autoimmune disorders, highlighting its potential as a unique CD19-targeting iNK cell product[3] - Century is enhancing its preclinical pipeline with programs engineered with Allo-Evasion™ 5.0, focusing on iPSC-derived 'tunable' CD4+/CD8+ aß T cells[3] Financial Position and Key Milestones | Metric | Value / Milestone | | :--- | :--- | | Cash Position (End Q1 2025) | $185.8M (cash, cash equivalents, and investments) | | Estimated Cash Runway | Into 4Q 2026 | | CNTY-101 Autoimmune Data | Expected in 2025 | | CNTY-308 Program | Expected to enter IND-enabling stage in mid-2025 | Technology Platform Century's technology platform leverages an iPSC foundation for scalable, reproducible cell therapy production, featuring proprietary Allo-Evasion™ engineering to enable immune evasion and potential repeat dosing iPSC Platform and Allo-Evasion™ Engineering Century's core technology is built on an induced pluripotent stem cell (iPSC) platform, which allows for the creation of multiple, genetically engineered cell types from a single-cell clone master cell bank. This enables scalability, reproducibility, and consistency. A key feature is the proprietary Allo-Evasion™ engineering, which is designed to protect the allogeneic cell therapies from the patient's immune system (T-cells, NK-cells, and antibodies), potentially allowing for repeat dosing without the need for continuous lymphodepletion and driving durable responses - The iPSC platform enables the creation of multiple cell types from a fully characterized single-cell clone, ensuring reproducibility and large batch sizes for scalability[4] - Allo-Evasion™ engineering is designed to protect therapy cells from the host's native T-cells, NK-cells, and antibody immunity, enabling potential re-dosing[4][5] - The technology has evolved, with CNTY-101 using Allo-Evasion™ 1.0 and newer programs like CNTY-308 incorporating Allo-Evasion™ 5.0, which adds protection from humoral immunity via an IgG degrading enzyme (IDP)[9][13][14] - Preclinical studies show the CD300a TASR ligand provides broad protection from host NK cells, and the IDP enzyme protects cells from complement-dependent (CDC) and antibody-dependent cellular cytotoxicity (ADCC)[11][15][16] Clinical Pipeline Century's clinical pipeline focuses on iPSC-derived cell therapies for autoimmune diseases and cancer, led by CNTY-101 in Phase 1 and advanced preclinical αβ iT cell programs Pipeline Overview Century Therapeutics is advancing a focused pipeline of iPSC-derived cell therapies targeting autoimmune diseases and cancer. The lead clinical candidate, CNTY-101, is in a Phase 1 trial for B-cell-mediated autoimmune diseases. The preclinical pipeline includes next-generation αβ iT cell programs like CNTY-308 and CNTY-341, which utilize enhanced Allo-Evasion™ 5.0 technology for autoimmune and malignancy indications, alongside programs for solid tumors Century Therapeutics Product Pipeline | Product | Targets | Indications | Research | IND-enabling | Phase 1 | | :--- | :--- | :--- | :--- | :--- | :--- | | CNTY-101 (iNK) | CD19 | B-cell-mediated autoimmune diseases | | | CALiPSO-1 | | CNTY-308 (αβ iT) | CD19 | B-cell-mediated autoimmune diseases, B-cell malignancies | ✓ | | | | CNTY-341 (αβ iT) | CD19 + CD22 | B-cell malignancies | ✓ | | | | Solid Tumors (iT) | Nectin-4/other | Solid tumors | ✓ | | | CNTY-101 Program CNTY-101 is an off-the-shelf, CD19-targeted CAR-iNK cell therapy candidate featuring Allo-Evasion™ 1.0. It is currently in the CALiPSO-1 Phase 1 trial for moderate to severe autoimmune diseases (SLE, LN, IIM, dcSSc). Supporting data from the ELiPSE-1 study in B-cell lymphoma demonstrated a favorable safety profile, deep B-cell depletion, and sustained exposure, reinforcing its potential for autoimmune applications - CNTY-101 is an allogeneic CAR-iNK cell therapy with six gene edits, including a CD19 CAR, Allo-Evasion™ technology, secreted IL-15 for persistence, and a safety switch[22][24] - The CALiPSO-1 Phase 1 study is enrolling up to 48 patients with moderate to severe SLE, LN, IIM, or dcSSc, with a dosing schedule of 1e9 cells per infusion[34][35] - In vitro studies show CNTY-101 eliminates B-cells from SLE patients with greater potency than primary CAR-T cells[31][32][33] Key Findings from ELiPSE-1 Study (R/R B-cell Lymphoma) | Finding | Detail | | :--- | :--- | | Safety Profile (n=23) | Favorable; no DLTs, no GvHD. Majority of infusions in outpatient setting | | Efficacy (DL 3B & 4B, n=9) | 77% ORR, 22% CR | | B-cell Depletion | Demonstrated deep and rapid B-cell depletion | | Pharmacokinetics (PK) | Sustained exposure at dose levels intended for autoimmune study; similar PK with or without endogenous lymphocytes | Next-Generation iT Cell Platform (CNTY-308, CNTY-341) Century is developing a next-generation platform of iPSC-derived αβ T cells (iT) to address the ~$4.5B CAR-T market. The lead candidate, CNTY-308, is a CD19-targeted CAR-iT with Allo-Evasion™ 5.0, designed for B-cell mediated diseases. Preclinical data show it has functional characteristics similar to primary CAR-T cells, including high proliferation, cytokine secretion, and long-term persistence. CNTY-341 is a dual-targeting (CD19/CD22) candidate for B-cell malignancies, and the platform is also being applied to solid tumors - The platform aims to replace and expand the current ~$4.5B autologous CAR-T market with an off-the-shelf product, addressing challenges like manufacturing time and patient access[59][60][61] - CNTY-308 is a CD19-targeted CD4+/CD8+ αβ iT-cell product with Allo-Evasion™ 5.0, which includes edits to evade T cell, NK cell, and humoral responses[62][63][64] - Preclinical studies demonstrate that Century's iPSC-derived CAR-αβT cells (CNTY-308) show comparable characteristics to primary CAR-T cells, including IL-2 secretion, repeat killing ability, and in vivo tumor control after rechallenge[68][70][75] - CNTY-341 is a dual-targeting (CD19/CD22) CAR-iT designed to reduce potential antigen escape in B-cell malignancies. The platform is also being developed for solid tumors with targets like Nectin-4, GPC3, and CD70[76][79][80] Platform and Manufacturing Century's integrated platform enables the generation of diverse iPSC-derived immune effector cells through precise gene editing, supported by robust in-house cGMP manufacturing for scalability and consistency iPSC Cell Foundry and Engineering Century's platform leverages the ability to generate multiple iPSC-derived immune effector cells (iNK, γδ iT, αβ iT) to match the optimal cell type to a specific disease. The company uses a precise, sequential CRISPR MAD7-mediated gene editing process on iPSCs. This creates a uniform, well-characterized engineered Master Cell Bank (MCB), which serves as the starting point for manufacturing, ensuring product consistency and avoiding issues from genetic aberrations - The platform can generate various cell types (CAR iNK, CAR γδ iT, CAR αβ iT), allowing the selection of the right cell for the right indication based on functional attributes like cytolytic capacity and proliferative potential[86][87] - Century utilizes precise CRISPR MAD7-mediated sequential gene editing to create engineered iPSC Master Cell Banks (MCBs), ensuring a uniform and quality-controlled starting material for all products[89][90][91] In-House Manufacturing and Scalability Century has established significant in-house manufacturing capabilities with a 53,000 sq. ft. cGMP facility, led by an experienced team. This vertical integration is designed to ensure product quality, consistency, and speed. The company is developing scalable production systems with the goal of achieving antibody-like scale and cost of goods, which would be disruptive for the cell therapy field - The company operates a 53,000 ft² purpose-built cGMP facility with an experienced in-house team, providing control over priorities, learning, and proprietary know-how[92] - The manufacturing process, starting from a single-cell clonal master bank, is designed for consistency, batch-to-batch reproducibility, and high cell fitness[92] - Development shows progress in scalable, dynamic cell production systems, aiming for antibody-like cost and scale[94][95] Conclusion and Outlook Century Therapeutics maintains a clear strategic focus on advancing iPSC-derived cell therapies, prioritizing CNTY-101 clinical development and supported by a strong preclinical pipeline and financial runway Summary of Strategy and Milestones Century Therapeutics reiterates its clear strategic focus on advancing its unique iPSC-derived cell therapies. The company is prioritizing the clinical development of CNTY-101 in autoimmune diseases, with initial data expected in 2025. Supported by a strong preclinical pipeline featuring Allo-Evasion™ 5.0 and a cash runway into late 2026, Century is positioned to achieve key value-driving milestones - The company's core strategy is to concentrate clinical development on CNTY-101 for autoimmune disorders while advancing an enhanced preclinical pipeline with next-generation technologies[97] Forward-Looking Milestones and Financials | Item | Detail | | :--- | :--- | | Clinical Focus | CNTY-101 in autoimmune disorders (Phase 1 CALiPSO-1) | | Key Data Readout | CNTY-101 autoimmune clinical data expected in 2025 | | Pipeline Advancement | CNTY-308 (αβ T cell) program to enter IND-enabling stage in mid-2025 | | Financial Runway | Estimated into 4Q 2026, with $185.8M in cash at end of Q1 2025 |