Cellectis S.A. — 2022 Form 20-F Summary
Reporting period: Fiscal year ended December 31, 2022; this is an annual report, not a standalone fourth-quarter filing. Financial statements are prepared under IFRS and presented in U.S. dollars. Calyxt’s Plants segment is classified as a discontinued operation for the periods presented.
Business context
Cellectis is a clinical-stage gene-editing biotechnology company developing allogeneic CAR T-cell candidates for cancer and gene-edited hematopoietic stem and progenitor cell programs for genetic diseases. It has no approved therapeutic products and no product-sales revenue. Its business depends on research and development, licensing and collaboration payments, government research credits, and financing. At December 31, 2022, Cellectis owned 49.1% of Calyxt, whose plant-based synthetic biology business was reported as discontinued operations and held for sale.
Financial performance and liquidity
| Metric | 2022 | 2021 |
|---|---|---|
| Revenue | $19.2 million | $30.3 million |
| Other income, mainly French research tax credit | $6.6 million | $8.3 million |
| Research and development expense | $97.5 million | $117.8 million |
| Selling, general and administrative expense | $17.5 million | $22.9 million |
| Operating loss | $(89.7) million | $(103.5) million |
| Loss from continuing operations | $(98.7) million | $(96.7) million |
| Loss from discontinued operations | $(15.3) million | $(28.4) million |
| Consolidated net loss | $(114.0) million | $(125.1) million |
| Net loss attributable to Cellectis shareholders; loss per share | $(106.1) million; $(2.33) | $(114.2) million; $(2.55) |
| Operating cash flow, consolidated | $(87.4) million | $(104.6) million |
Revenue fell 36.8% year over year, primarily because of lower collaboration-agreement revenue. The 2022 total included a $15.8 million Servier milestone tied to the first patient dosed in Allogene’s ALPHA2 study, $1.5 million of Cytovia milestones and $1.0 million related to a licensee change-of-control provision. R&D expense declined 17.3%, mainly with lower external and manufacturing-related spending and lower personnel and stock-based compensation expense. SG&A declined 23.5%. The narrower consolidated net loss reflected lower expenses and a smaller discontinued-operations loss, partly offset by reduced revenue and a $12.1 million fair-value loss on the Cytovia convertible note. Adjusted net loss attributable to shareholders, a non-IFRS measure excluding non-cash stock compensation, was $98.1 million versus $101.7 million in 2021.
At year-end, Cellectis excluding Calyxt had $89.8 million of cash and cash equivalents and a $7.9 million current financial asset representing the Cytovia note. Calyxt separately had $3.4 million of cash and $0.1 million of restricted cash. Consolidated assets were $261.2 million and shareholders’ equity was $125.9 million. Cellectis reported $57.2 million of lease debt and $25.6 million of other financial liabilities, including its state-guaranteed loan. Consolidated investing cash outflow was $2.8 million and financing cash inflow was $1.1 million.
Management estimated that Cellectis’s cash and cash equivalents, current financial assets, expected operating cash flows, research funding and borrowing of €35 million under the EIB facility would fund Therapeutics operations into the third quarter of 2024. The EIB facility provides up to €40 million, but was undrawn at year-end and each tranche is conditional. Cellectis reported $106.8 million in contractual obligations, principally leases and financing, including $18.5 million for the state-guaranteed loan.
Material changes, outlook and risks
- Pipeline and safety: Cellectis sponsored four clinical studies at year-end. Preliminary December 2022 UCART22 results showed anti-tumor activity in three of five patients at one dose level, with no dose-limiting toxicities reported in that small group. Preliminary UCART123 data included two Grade 5 dose-limiting toxicities associated with CRS in the FCA lymphodepletion arm. Patient recruitment in AMELI-01 had previously paused following a Grade 5 CRS event; the protocol was modified and recruitment restarted in an FCA two-dose arm with prophylactic tocilizumab. The results are preliminary and do not establish efficacy or safety.
- Licensing and counterparties: Servier notified Cellectis in September 2022 that it was discontinuing involvement in CD19 product development and purported to allow Allogene to seek rights outside the United States. Cellectis disputes Servier’s interpretation and alleges potential breaches; it was evaluating contractual remedies. Milestones and royalties depend on licensee development, regulatory progress and commercialization.
- Cytovia note: The note’s reported fair value was $7.9 million after a $12.1 million 2022 fair-value loss. Under amended terms it bears 10% interest, provides for 50% repayment on April 30, 2023 and has a June 30, 2023 final maturity, subject to conversion provisions. Collection and conversion remain uncertain.
- Financing and dilution: In February 2023, Cellectis completed a follow-on offering yielding approximately $22.8 million net. An ATM program permits up to $60 million of additional ADS sales. EIB funding requires warrants and satisfaction of tranche conditions; borrowing also carries covenants and interest that accrues in kind.
- Calyxt: The proposed all-stock merger with Cibus, signed in January 2023, was expected to close in the second quarter of 2023 and would reduce Cellectis’s expected ownership to about 2.4%. Calyxt had $3.5 million of cash, cash equivalents and restricted cash at year-end and management disclosed substantial doubt about its ability to continue as a going concern for 12 months or more. Cellectis’s guarantee of Calyxt’s headquarters lease was estimated at $24.4 million over the remaining lease period; termination depended on future conditions.
- Other key risks: Clinical trial delays or failure, serious adverse events, manufacturing scale-up and supply constraints, regulatory uncertainty, reliance on third parties, competition, foreign-exchange exposure, and potential need for additional capital. Cellectis stated it did not believe it was a PFIC for 2022, but that determination was uncertain and must be reassessed annually.
Management said it expected expenses and operating losses to continue as it advances trials, manufacturing and research programs. It does not expect material therapeutic product revenue unless and until a candidate is approved and commercialized, an outcome that may take years or never occur. The company reported effective disclosure controls and internal control over financial reporting; the auditor gave unqualified opinions on the financial statements and internal controls.
Important facts for investors to verify
- Whether EIB tranche conditions are met, how much is drawn, and the final warrant terms and potential dilution.
- Whether Cellectis’s projected runway into Q3 2024 remains supported by actual cash use, license payments and research funding.
- Final and updated clinical data, particularly UCART123 safety and the durability of early UCART22 responses.
- Resolution and financial consequences of the Servier CD19 dispute, and continued development by licensees.
- Repayment, conversion or recovery of the Cytovia note by its stated maturity, and any further fair-value changes.
- Completion and terms of the Calyxt-Cibus merger, the status of Calyxt’s going concern position, and any release of Cellectis’s lease guarantee.