On August 11, 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 second quarter ended June 30, 2022 (Press release, Century Therapeutics, AUG 11, 2022, View Source [SID1234618154]).
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"We are excited about our recent IND submission for our lead candidate, CNTY-101, and pending FDA clearance, are looking forward to initiating the Phase 1 ELiPSE-1 trial in relapsed/refractory lymphoma," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We continue to make steady progress in building a best-in-class allogeneic cell therapy platform and achieved a key milestone this quarter in establishing the iNK 3.0 Common Progenitor, which we believe will accelerate new candidate selection. Additionally, we look forward to providing updates on our gamma delta iT platform and other program advancements in the coming months."
Business Highlights
The Company presented 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 held on May 16-19, 2022 in Washington, D.C. A copy of the presentation is available in the Posters section of Century’s website.
During a Research and Development Event in June, Century’s management team discussed CNTY-103, the Company’s first solid tumor candidate for glioblastoma, the establishment of the Common Progenitor iNK 3.0, and progress on the Company’s next-generation iPSC-based cell therapy platform. Century expects to submit an Investigational New Drug (IND) application for CNTY-103 in 2024.
The Company’s current Good Manufacturing Practice (cGMP) manufacturing facility in Branchburg, New Jersey is operational and undergoing qualification.
Century was added to the Russell Microcap Index in June 2022.
Subsequent Events and Upcoming Milestones
Following the recent submission of the IND application for CNTY-101, the Company remains on track to initiate its Phase 1 ELiPSE-1 clinical trial in the second half of 2022, subject to U.S. Food and Drug Administration (FDA) clearance of the application. ELiPSE-1 will 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.
Second Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents, and investments were $429.4 million as of June 30, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $61.2 million for the six months ended June 30, 2022 (which includes deferred revenue from the Bristol-Myers Squibb (BMS) collaboration of $120.7M) compared to net cash used in operations of $40.7 million for the six months ended June 30, 2021.
Collaboration Revenue: Collaboration revenue was $1.4 million for the three months ended June 30, 2022, generated through the Company’s collaboration, option and license agreement with BMS.
Research and Development (R&D) expenses: R&D expenses were $24.5 million for the three months ended June 30, 2022, compared to $18.9 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, offset by a decrease in collaboration expenses with FUJIFILM Cellular Dynamics, Inc. (FCDI) as the scope of work with FCDI has narrowed down to primarily manufacturing CNTY-101 clinical supply.
General and Administrative (G&A) expenses: G&A expenses were $8.3 million for the three months ended June 30, 2022, compared to $4.1 million for the same period in 2021. The increase was primarily 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, and increased information technology and facility costs.
Net loss: Net loss was $31.0 million for the three months ended June 30, 2022, compared to $23.3 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 investments will support operations into 2025.