PHILADELPHIA, PA — Century Therapeutics, Inc. (NASDAQ: IPSC), a clinical-stage biotechnology company, reported financial results and business highlights for the first quarter ended March 31, 2023.
“We are keenly focused on advancing our next generation iNK and gamma delta iT platforms to deliver transformative allogeneic cell therapies to patients with unmet need,” said Greg Russotti, Ph.D., interim Chief Executive Officer, Century Therapeutics. “For our lead candidate, CNTY-101, we remain on track to report initial data from Schedule A of the ongoing Phase 1 ELiPSE-1 trial in patients with relapsed or refractory CD19 positive B-cell lymphomas by year end. With a strong balance sheet expected to support operations into 2026 and a highly talented team, we believe we are well positioned to successfully execute on our mission.”
Business Highlights & Upcoming Milestones
- At the American Association for Cancer Research (AACR) Annual Meeting in April 2023, the Company presented preclinical data from its iPSC-based cell therapy platform supporting the selection of CNTY-101 as its lead product candidate. Additional preclinical data characterizing epigenetic and transcriptomic donor-specific differences iNK cells were also shared. A copy of each poster is available in the “Science” section of the Company’s website at https://www.centurytx.com/science/.
- In March 2023, the Company announced the appointment of Greg Russotti, Ph.D., as interim Chief Executive Officer. Dr. Russotti, who served as the Company’s Chief Technology Officer since January 2020, succeeds Lalo Flores, Ph.D., who stepped down as Chief Executive Officer and as a member of the Company’s Board of Directors. In addition, Michael C. Diem, M.D., was promoted to the role of Chief Financial Officer and Hy Levitsky, M.D., assumed his prior role as President of Research and Development.
- The first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas is ongoing. The Company remains on track to report preliminary data from Schedule A of the trial, including pharmacokinetics, pharmacodynamics, and safety, by year end.
- At the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting, the Company will present a Trials in Progress poster related to its Phase 1 ELiPSE-1 trial. A copy of the poster, titled, “The ELiPSE-1 Study: A Phase 1 Multicenter Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B Cell Malignancies”, will be made available on the Posters section of Century’s website following the presentation.
First Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents, and marketable securities were $334.8 million as of March 31, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $29.2 million for the three months ended March 31, 2023, compared to net cash provided by operations of $86.8 million for the three months ended March 31, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $122.1 million).
- Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option and license agreement with Bristol-Myers Squibb was $1.7 million for the three months ended March 31, 2023, compared to $1.1 million for the same period in 2022.
- Research and Development (R&D) expenses: R&D expenses were $24.9 million for the three months ended March 31, 2023, compared to $21.2 million for the same period in 2022. The increase in R&D expenses was primarily due to an increase in personnel expenses related to the reduction in force in January of 2023, costs for preclinical studies and clinical expenses for advancing CNTY-101, and facility costs.
- General and Administrative (G&A) expenses: G&A expenses were $8.9 million for the three months ended March 31, 2023, compared to $7.3 million for the same period in 2022. The increase in G&A expenses was primarily due to an increase in personnel-related expenses to build our infrastructure, as well as increased information technology and facility costs.
- Net loss: Net loss was $31.3 million for the three months ended March 31, 2023, compared to $37.5 million for the three months ended March 31, 2022.
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.
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