Century Therapeutics, Inc. — 2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. The filing describes a preclinical-stage biotechnology company developing off-the-shelf, iPSC-derived natural killer (iNK) and T-cell (iT) therapies for cancer. It reports annual results, not standalone fourth-quarter results.
Financial performance and position
| Metric | 2021 | 2020 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $75.6 million | $39.7 million |
| General and administrative expense | $19.2 million | $9.5 million |
| Operating loss | $94.9 million | $53.9 million |
| Net loss | $95.8 million | $53.6 million |
| Net loss per share, basic and diluted | $2.96 | $7.16 |
| Cash used in operating activities | $89.0 million | $41.3 million |
| Cash, cash equivalents and investments at year-end | $358.8 million | $76.8 million |
Margins are not meaningful because the company had no revenue. Net loss increased by $42.2 million; R&D expense rose $36.0 million, mainly from higher personnel, research, facility and collaboration costs. G&A increased $9.7 million, reflecting personnel, public-company, insurance and professional costs. The 2020 comparison included a $4.7 million write-off of acquired in-process research and development; 2021 had no such charge.
At December 31, 2021, total assets were $437.4 million and total liabilities were $41.1 million. Current assets were $228.2 million versus current liabilities of $15.7 million. The company reported $10.0 million principal outstanding under its Hercules loan (approximately $9.9 million carrying value); scheduled debt payments, including the end-of-term fee, totaled $10.4 million. Operating lease liabilities were $15.2 million on the balance sheet, with additional future lease commitments, including a lease not yet commenced at year-end.
Cash provided by financing activities was $417.8 million, primarily from the IPO and Series C financing. Investing cash outflow was $298.3 million, chiefly reflecting purchases of investments and property and equipment. The IPO generated $221.4 million in net proceeds. The financial statements received an unqualified audit opinion; the auditor did not opine on internal control effectiveness.
Material changes and business developments
- The company completed its IPO in June 2021 and converted preferred shares into common stock.
- R&D spending and operating cash use increased substantially as the company expanded its research, workforce, facilities and preclinical work.
- In January 2022, after year-end, Bristol Myers Squibb (BMS) agreed to pay $100 million upfront for a collaboration and purchased $50 million of common stock. The $150 million was received in the first quarter of 2022 and is not included in 2021 year-end cash and investments.
- Management said year-end resources, including the BMS proceeds, were expected to fund operating expenses and capital expenditures into 2025, based on assumptions that may prove incorrect. The filing also states resources should cover at least 12 months from issuance of the financial statements.
- The Branchburg, New Jersey manufacturing facility completed construction in early 2022; fit-out and qualification remained underway. FCDI was expected to manufacture clinical supply for the lead candidate.
Outlook, commentary and key risks
All candidates remained in preclinical development at year-end, and the company had never generated product revenue. Management expected losses and expenses to rise as it advanced development, initiated clinical trials, built manufacturing capabilities and expanded operations. Planned IND timing was mid-2022 for CNTY-101, 2023 for CNTY-103, and 2024 for CNTY-102, CNTY-104 and CNTY-106. These are expectations, not assured milestones.
The lead program, CNTY-101, is a CD19-targeted iNK candidate for relapsed or refractory B-cell lymphoma. Other programs target glioblastoma, B-cell malignancies, acute myeloid leukemia and multiple myeloma. The proposed BMS collaboration covers AML and multiple myeloma initially, with options for up to two additional programs; future milestone and royalty income depends on program progress, option exercise, approvals and sales.
Principal risks include clinical and regulatory uncertainty for novel gene-edited cell therapies; reliance on CNTY-101 and shared platform technology; manufacturing scale-up, cryopreservation and product consistency; dependence on FCDI and other third parties; competition; limited patent protection (the company reported no issued patents covering its candidates); and the possibility that additional financing will be needed. COVID-19 had caused modest discovery and development delays, and further disruption remained possible. The company had no material legal proceedings.
Important facts for investors to verify
- Whether CNTY-101’s IND was filed and accepted, and whether clinical trial initiation and enrollment match the stated timetable.
- Actual cash use, investment liquidity and runway against management’s projection into 2025; confirm how the BMS proceeds are reflected in subsequent-period financials.
- Progress on Branchburg facility qualification, clinical manufacturing capacity, cryopreservation and supply dependence on FCDI.
- Terms and progress of BMS program options, milestones, royalties and any co-promotion rights; these potential payments are contingent, not guaranteed revenue.
- Patent prosecution and licensing status, including protection for core platform technology and candidates, and any restrictions under the Bayer option agreement.