On November 10, 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 third quarter ended September 30, 2022 (Press release, Century Therapeutics, NOV 10, 2022, View Source [SID1234623831]).

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"We made steady progress this quarter with our next generation platform and robust portfolio of cell therapy product candidates, including FDA clearance of our first IND for CNTY-101 in relapsed/refractory B-cell malignancies," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We are focused on initiating the Phase 1 ELiPSE-1 trial to assess the potential of our Allo-EvasionTM edits, designed to prevent immunological rejection and enhance persistence of multiple dosing regimens of CNTY-101 with the aim to increase the proportion of patients that achieve durable responses. We look forward to sharing meaningful preclinical data updates at the SITC (Free SITC Whitepaper) meeting this week on both our iNK and gamma delta iT cell platforms, and to discussing our pipeline progress and our solid tumor strategy at our virtual Research and Development Day tomorrow."

"As we continue to realize efficiencies in our platform and synergies across our pipeline, we are updating our financial guidance for the year by reducing our expected GAAP Operating Expenses to $140 million and $145 for the full year ended 2022," said Michael Diem, Chief Business Officer, Century Therapeutics. "We will remain fiscally responsible as we continue to execute and deliver on our platforms, programs and key milestones, leaving us well positioned with cash runway into 2025."

Business Highlights

●Following notification from the U.S. Food and Drug Administration (FDA) that the Phase 1 ELiPSE-1 study of the Company’s first clinical product candidate, CNTY-101, may proceed, Century expects to initiate the trial imminently. The Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. All patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for three days. Schedule A of the trial includes a single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule B will evaluate a three-dose schedule per cycle of CNTY-101. Patients who demonstrate a clinical benefit are eligible for additional cycles of treatment with or without additional lymphodepletion pending FDA consent.

●In October 2022, the Company announced the appointment of Daphne Quimi and Timothy Walbert to its Board of Directors. Ms. Quimi is currently Chief Financial Officer of Amicus Therapeutics and brings operational experience in public accounting and financial reporting to Century. Mr. Walbert is currently Chairman, President, and Chief Executive Officer of Horizon Therapeutics, and brings expertise in product portfolio building and commercialization.

Subsequent Events and Upcoming Milestones

●Century plans to present preclinical data from its iPSC-based cell therapy platform in two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting today, November 10, 2022, and tomorrow, Friday, November 11, 2022. A copy of the presentations will be made available in the Posters section of Century’s website.

●The Company will host a virtual Research and Development (R&D) Day on Friday, November 11, 2022, from 8:00 AM to 9:30 AM ET. The R&D Day will feature presentations from the Company’s management team and Jonathan Rosenberg, M.D., Chief of the Genitourinary Oncology Service at the Memorial Sloan Kettering Cancer Center (MSKCC), Physician at Memorial Hospital at MSKCC, and Professor of Medicine at Weill Cornell Medical College. The event will focus on the Company’s gamma delta iT cell platform and solid tumor strategy and include a discussion of preclinical data to be presented at the SITC (Free SITC Whitepaper) Annual Meeting. For additional information on how to access the event, please visit the Events & Presentations section of Century’s website.

Third Quarter 2022 Financial Results

●Cash Position: Cash, cash equivalents, and investments were $395.3 million as of September 30, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $36.9 million for the nine months ended September 30, 2022 (which includes deferred revenue from the Bristol-Myers Squibb (BMS) collaboration of $118.5 million) compared to net cash used in operations of $64.7 million for the nine months ended September 30, 2021.

●Collaboration Revenue: Collaboration revenue was $2.2 million for the three months ended September 30, 2022, generated through the Company’s collaboration, option and license agreement with BMS.

●Research and Development (R&D) expenses: R&D expenses were $25.9 million for the three months ended September 30, 2022, compared to $19.5 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 $8.1 million for the three months ended September 30, 2022, compared to $6.3 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 $30.7 million for the three months ended September 30, 2022, compared to $26.0 million for the same period in 2021.

Financial Guidance

●The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $140 million and $145 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.