On 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, reported financial results and business highlights for the full year ended December 31, 2023 (Press release, Century Therapeutics, MAR 14, 2024, View Source [SID1234641157]).

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"We enter 2024 following a series of significant milestones, highlighted by our presentation at ASH (Free ASH Whitepaper) 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.

· In December 2023, Century presented initial clinical data from the Phase 1 ELiPSE-1 Trial of CNTY-101 in relapsed/refractory (r/r) B-cell lymphomas. Findings supporting the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion edits were shared at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data showed that CNTY-101 was well-tolerated at Dose Level 1 (100 million cells) in high-risk, heavily pretreated R/R B-cell lymphoma patients. The Company also shared a case study of one patient demonstrating a six-month durable complete response (CR) following multiple cycles of CNTY-101 without lymphodepletion.

· In December 2023, Century also shared results from additional patients in the ELiPSE-1 clinical trial of CNTY-101 treated at Dose Level 1, as well as preliminary data from patients treated at Dose Level 2 (300 million cells) demonstrating encouraging early response signals, including 2 CRs and 1 partial response (PR) out of 7 heavily pre-treated patients at these dose levels. CNTY-101 also demonstrated a favorable tolerability profile and no initial evidence of allo-rejection. The Company believes these results support advancement to higher doses and a more dose intense regimen. The ability to prolong drug exposure by repeat dosing may provide significant treatment advantages in lymphoma, including enhanced objective response rates and duration of response.

· In December 2023, the Company received FDA clearance for the Investigational New Drug (IND) application of CNTY-101 in patients with moderate to SLE who have failed at least two standard immunosuppressive therapies. This represents the second IND clearance for CNTY-101 and the first in an autoimmune and inflammatory disease indication. Century plans to initiate a Phase 1 clinical trial, CALiPSO-1, in the first half of 2024, with initial data expected by year-end 2024.

· Century plans to share six poster presentations at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held on April 5-10, 2024, in San Diego, California, showcasing Century’s recent research in enhancing the safety and efficacy of its iPSC-derived treatment candidates for oncology and immunology indications. The upcoming abstracts highlight the Company’s end-to-end capabilities in iPSC reprogramming and differentiation, gene editing, protein engineering and computational biology. Additionally, the Company will share new preclinical data on additional Allo-Evasion edits that could further support Century’s multi-dosing strategy. The following abstracts are currently available through the AACR (Free AACR Whitepaper) conference website, and the posters will be made available on the Century website following the presentations:

o Engineered Expression Of HLA-E And HLA-G Protects iPSC-Derived Cells from Killing by Primary NK Cells

o CXCR4 Transgene Improves In Vivo Migration and Efficacy of Engineered iPSC-Derived Natural Killer Cells

o Screening iPSC Lines for Optimal Characteristics of Differentiation into Immune Effector Cells for Clinical Programs

o Discovery of a Novel Nectin-4 iPSC-derived Cell Therapy for the Treatment of Solid Tumors

o The Discovery of a Novel CD19xCD22 Dual-Targeting CAR For the Development of an iPSC-Derived Cell Therapy

o Discovery Of Inhibitory CAR Target DSG1 For Damping Nectin-4 On-Target Off-Tumor Toxicity in iPSC-Derived CAR-T Cell Therapy

Business Highlights

· In November 2023, the Company announced the appointment of Brent Pfeiffenberger, Pharm.D., MBA, as Chief Executive Officer.

· In November 2023, Century and FUJI Cellular Dynamics (FCDI) announced a worldwide license agreement where FCDI granted Century non-exclusive licenses for the development and commercialization of cell therapies derived from iPSCs for the treatment of autoimmune and inflammatory diseases. Additionally, they announced the expansion of their existing 2018 license agreements for iPSC-derived cancer immunotherapeutics.

Full Year 2023 Financial Results

· Cash Position: Cash, cash equivalents, and marketable securities were $261.8 million as of December 31, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $88.3 million for the twelve months ended December 31, 2023, compared to net cash provided by operations of $14.1 million for the twelve months ended December 31, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $118.0 million).

· Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option, and license agreement with Bristol-Myers Squibb (BMS) was $2.2 million for the year ended December 31, 2023, compared to $5.2 million for the same period in 2022.

· Research and Development (R&D) expenses: R&D expenses were $92.7 million for the year ended December 31, 2023, compared to $97.2 million for the year ended December 31, 2022. The decrease in R&D expenses was primarily due to the Company’s 2023 reorganization and reprioritization of early-stage programs and discovery platforms as well as a decline in sponsored research activities.

· General and Administrative (G&A) expenses: G&A expenses were $34.7 million for the year ended December 31, 2023, compared to $31.9 million for the year ended December 31, 2022. The increase in G&A expenses was primarily due to increases in stock-based compensation and recruiting fees.

· Impairment of Long-lived Assets: A one-time impairment charge of $16.4 million was recorded in connection with the strategic decision to consolidate three of the Company’s existing leased facilities in Philadelphia as well as one in Seattle.

· In-Process Research and Development: In-process research and development expenses were $5.0 million for the year ended December 31, 2023, compared to $10.0 million for the year ended December 31, 2022. In 2023, $4.0 million was a result of entering into a worldwide license agreement with FCDI for the development and commercialization of iPSC-derived therapies for treatment of inflammatory and autoimmune diseases, and $1.0 million related to a milestone fee paid pursuant to the license for filing of the IND for CNTY-101 in SLE.

· Net Loss: Net loss was $136.7 million for the year ended December 31, 2023, compared to $131.0 million for the year ended December 31, 2022.

Financial Guidance

· The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $135 million and $145 million.

· The Company estimates its cash, cash equivalents, and investments will support operations into 2026.