Nanobiotix S.A. — FY2022 Form 20-F
Reporting period: Fiscal year ended December 31, 2022; this is an annual report, not a standalone fourth-quarter filing. Financial statements are audited and prepared under IFRS, in euros.
Business context
Nanobiotix is a clinical-stage biotechnology company developing NBTXR3, an injectable hafnium-oxide nanoparticle intended to enhance radiotherapy. The company reported no product sales and no revenue in 2022. Its lead program includes a global Phase 3 trial in locally advanced head and neck cancer; Hensify has EU CE marking for soft-tissue sarcoma, but the company said it did not plan to commercialize it before approval in a second indication.
Key financial metrics
| Metric (€ millions unless stated) | FY2022 | FY2021 |
|---|---|---|
| Revenue | 0.0 | 0.01 |
| Other income, mainly research tax credits | 4.8 | 2.6 |
| Operating loss | (46.7) | (52.6) |
| Net loss | (57.0) | (47.0) |
| Operating cash used | (37.1) | (29.9) |
| Cash and cash equivalents at year-end | 41.4 | 83.9 |
| Total financial liabilities | 53.2 | 46.0 |
| Shareholders’ equity | (27.0) | 26.8 |
- R&D expense was €32.6 million, up 7.4%; SG&A was €17.9 million, down 8.1%. There is no meaningful product gross margin because product sales have not begun.
- Other income rose mainly because the French research tax credit increased to €4.1 million from €2.5 million. It is not product revenue.
- Cash fell by €42.5 million. Investing activities provided €0.1 million; financing activities used €5.7 million, chiefly for debt and lease repayments.
- Reported current assets were €52.4 million and current liabilities €37.9 million. However, the going-concern note also states negative working capital of €22.7 million; these disclosures do not reconcile clearly in the supplied filing text.
Changes, debt and liquidity
- Operating loss narrowed by €5.9 million, reflecting higher other income and lower operating expenses, including PharmaEngine termination payments of €1.0 million versus €5.4 million in 2021.
- Net loss widened by €10.0 million, largely because net financial results shifted from €5.6 million income to €10.3 million expense. This included a €6.9 million one-off EIB loan restructuring loss and higher EIB interest expense.
- The October 2022 EIB amendment deferred repayment of €25.3 million principal, generally to commercialization-linked dates or June 30, 2029. It also provides for a €20 million milestone payment and sales-based royalties. The reported EIB liability carrying value was €35.8 million; it includes accounting valuation effects and is not the same as principal outstanding.
- The EIB covenant requires cash at least equal to outstanding principal (€25.3 million at year-end). A €15 million temporary waiver ran through July 31, 2023. An extension to January 31, 2024 was conditional on a qualifying partnership becoming effective by July 31 and documentation being signed within 15 days after the filing. The filing said cash alone was expected to fund operations only into Q3 2023 and warned of substantial doubt about the company’s ability to continue as a going concern.
- The company had a Kepler Cheuvreux equity line for up to 5.2 million shares over 24 months, at a discount of up to 5%; no warrants had been exercised by year-end. Use could dilute shareholders.
Outlook, commentary and risks
- Management expected cash operating expenses to be slightly higher than in 2022 as clinical trials continued, and said additional funding would be needed. No specific revenue or earnings guidance was provided.
- NANORAY-312 was designed to enroll about 500 patients. Sites were active across major regions, with first patients randomized in Europe in January 2022, Asia in August, and the U.S. in December. LianBio was expected to enroll about 100 patients in its territories.
- Management reported preliminary Phase 1 expansion results in head and neck cancer, including median overall survival of 23 months in 44 evaluable patients at a February 2022 cutoff. These are non-randomized, preliminary data and are not confirmatory Phase 3 results.
- The completed STS Phase 2/3 trial reported pathological complete response of 16.1% with NBTXR3 plus radiotherapy versus 7.9% with radiotherapy alone, and R0 margins of 77% versus 64%. Hensify’s CE marking does not itself establish commercial sales or approval in other indications.
- Key risks include clinical efficacy and safety uncertainty, patient recruitment and trial delays, manufacturing scale-up, regulatory classification and approval, dependence on partners and suppliers, and access to financing. Russia’s invasion of Ukraine caused unrecoverable trial start-up costs and could have delayed NANORAY-312.
- The auditor issued an unmodified opinion on the financial statements but included a going-concern explanatory paragraph. Management also reported ineffective internal control over financial reporting due to a material weakness involving technical accounting supervision and processes for complex judgments, including going concern and debt valuation.
Most important facts for investors to verify
- Whether the EIB cash-covenant waiver was extended or the company secured funding or a partnership, and the resulting runway and covenant status.
- Current cash, quarterly cash burn, debt obligations and the accounting-to-cash reconciliation for EIB debt, royalties and the €20 million milestone.
- The working-capital disclosure discrepancy between the balance-sheet totals and the stated €22.7 million deficit.
- Recruitment progress, interim and final outcomes, safety, and regulatory plans for NANORAY-312 and the immuno-oncology studies.
- Whether the reported material weakness has been remediated, and the extent of potential dilution if the equity line or other financing is used.