On March 16, 2023 Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the full-year ended December 31, 2022 (Press release, Century Therapeutics, MAR 16, 2023, View Source [SID1234628891]).
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"We are excited about the significant progress of our next generation platforms for iNK and gamma delta iT product candidates, including the commencement of our Phase 1 ELiPSE-1 trial for CNTY-101. We are well-positioned for a productive 2023 as we continue building on the foundational investments we’ve made in iPSC technology, genetic editing, and manufacturing," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We have a strong balance sheet and are realizing platform and operational efficiencies which we believe extend our cash runway into 2026 and allow us to deliver on our key platform and program milestones."
Business Highlights
· In February 2023, the Company announced that the first patient has been dosed in the first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas. As a leading next-generation allogeneic cell therapy candidate, CNTY-101 is the first to test the potential of a finite, repeat dosing regimen and the ability to deliver more durable responses enabled by Allo-Evasion gene edits designed to prevent rejection. Initial data from Schedule A of the trial is planned to be available by year-end 2023.
· In January 2023, the Company announced an internal portfolio prioritization which allows for the acceleration of key programs including CNTY-107 in Nectin-4+ tumors, and extended the Company’s expected cash runway into 2026.
· The Company has selected targets for CNTY-102, a CAR-iT product candidate, against CD19 and CD22 for relapsed/refractory B-cell lymphoma and other B-cell malignancies. The Company expects to share pre-clinical data later this year.
· In November 2022, the Company presented preclinical data in two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting. The data presented supported the Company’s next generation platform for iPSC-derived NK cells and demonstrated that iPSC-derived CAR gamma delta T cells effectively control solid tumors as monotherapy and in combination with a therapeutic antibody. The Company also hosted a virtual Research and Development Day, where the Company announced the nomination of the next pipeline program, CNTY-107
Full Year 2022 Financial Results
· Cash Position: Cash, cash equivalents, and marketable securities were $367.4 million as of December 31, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $14.1 million for the twelve months ended December 31, 2022 (which includes deferred revenues from the Bristol-Myers Squibb (BMS) collaboration of $118.0 million), compared to net cash used in operations of $89.0 million for the twelve months ended December 31, 2021.
· Collaboration Revenue: Collaboration revenue was $5.2 million for the twelve months ended December 31, 2022, generated through the Company’s collaboration, option and license agreement with BMS.
· Research and Development (R&D) expenses: R&D expenses were $97.2 million for the year ended December 31, 2022, compared to $75.6 million for the year ended December 31, 2021. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s R&D capabilities, costs for preclinical studies and clinical expenses for advancing CNTY-101, costs for laboratory supplies, and facility costs.
· General and Administrative (G&A) expenses: G&A expenses were $31.9 million for the year ended December 31, 2022, compared to $19.2 million for the year ended December 31, 2021. The increase in G&A expenses was primarily due to an increase in employee headcount and additional costs to operate as a public company.
· Net loss: Net loss was $130.9 million for the year ended December 31, 2022, compared to $95.8 million for the year ended December 31, 2021.
Financial Guidance
· The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $135 million and $145 million, including non-cash stock-based compensation expense of $12 million to $17 million.
· The Company estimates its cash, cash equivalents, and investments will support operations into 2026.