On May 16, 2022 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the first quarter ended March 31, 2022 (Press release, Celcuity, MAY 16, 2022, View Source [SID1234614647]).
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"We are off to a strong start in 2022, which we expect will be a transformational year for Century as we transition into a clinical-stage organization," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "Looking ahead, we remain on track to submit our first IND application for our lead program, CNTY-101, mid-year, with the Phase 1 ELiPSE-1 trial for CNTY-101 in relapsed/refractory lymphoma expected to commence in the second half of 2022. We are continuing to invest in our comprehensive, next-generation iPSC-based cell therapy platform, and believe we are well positioned to advance multiple product candidates into the clinic over the next several years. We look forward to providing updates at scientific congresses this year and our upcoming virtual R&D Day next month"
Business Highlights & Upcoming Milestones
Earlier this month, the Company presented preclinical data at the 18th Annual PEGS Boston Conference & Exposition, on the discovery and optimization of CD22 VHH antibodies for CAR T cell therapy.
The Company plans to present preclinical data on MAD7, a novel CRISPR nuclease used to enable the genetic engineering of iPSC-derived NK and T cell product candidates, during a poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting being held May 16-19, 2022 in Washington, D.C. Full abstracts are currently available through the ASGCT (Free ASGCT Whitepaper) conference website.
Virtual research and development update to be held June 13, 2022, at 4:30 PM ET. Century’s management team will discuss CNTY-103 and progress on the next-generation platform. Dr Sheila Singh, Professor of Surgery and Biochemistry, Chief Pediatric Neurosurgeon at McMaster Children’s Hospital, the Division Head of Neurosurgery at Hamilton Health Sciences, and the inaugural Director of McMaster’s new Cancer Research Centre will discuss the current treatment paradigm in GBM.
The Company remains on track to initiate ELiPSE-1, its Phase 1 clinical trial to assess CNTY-101 in patients with relapsed/refractory CD19 positive aggressive lymphoma or indolent lymphoma after at least two prior lines of therapy, including patients who have received prior CAR-T cell therapy, in the second half of 2022 subject to U.S. Food and Drug Administration acceptance of its Investigational New Drug (IND) application, which is expected to be submitted in mid-2022.
The Company’s current Good Manufacturing Practice (cGMP) manufacturing facility in Branchburg, New Jersey is expected to be operational in 2022.
Century expects to submit an IND application for CNTY-103 in 2023. CNTY-103 is the Company’s first solid tumor candidate for glioblastoma.
First Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents, and investments were $466.4 million as of March 31, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $86.8 million for the three months ended March 31, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $122.1M) compared to net cash used in operations of $22.2 million for the three months ended March 31, 2021.
Collaboration Revenue: Collaboration revenue was $1.1 million for the three months ended March 31, 2022, generated through the Company’s collaboration, option and license agreement with BMS.
Research and Development (R&D) expenses: R&D expenses were $21.2 million for the three months ended March 31, 2022, compared to $15.4 million for the same period in 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 pre-clinical studies, costs for laboratory supplies and facility costs.
General and Administrative (G&A) expenses: G&A expenses were $7.3 million for the three months ended March 31, 2022, compared to $2.7 million for the same period in 2021. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount, an increase in directors’ and officers’ insurance expense, and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company.
In-process research and development (IPR&D) expenses: One-time IPR&D expenses were $10.0 million for the three months ended March 31, 2022, in order to amend the FCDI agreement to gain access to the territory rights of Japan as a result of the Collaboration Agreement with BMS.
Net loss: Net loss was $37.5 million for the three months ended March 31, 2022, compared to $18.3 million for the same period in 2021.
Financial Guidance
The Company expects full year GAAP Operating Expenses to be between $155 million and $165 million including non-cash stock-based compensation expense of $10 million to $15 million.
The Company expects its cash, cash equivalents, and marketable securities will support operations into 2025.