Nanobiotix S.A. — 2021 Form 20-F Summary
Reporting period: Fiscal year ended December 31, 2021. 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, hafnium-oxide nanoparticles injected into tumors and activated by radiotherapy. The company has CE marking to commercialize Hensify (NBTXR3) for locally advanced soft-tissue sarcoma in the EU, but had not begun commercialization and had generated no product sales or royalties. Development priorities were head and neck cancer and combinations with immuno-oncology treatments.
Key financial results
| Metric | 2021 | 2020 |
|---|---|---|
| Revenue | €0.01 million | €0.05 million |
| Other income, mainly research tax credits and grants | €2.64 million | €2.46 million |
| Research and development expenses | €30.38 million | €24.33 million |
| Selling, general and administrative expenses | €19.43 million | €14.61 million |
| Operating loss | €52.58 million | €36.43 million |
| Net financial income | €5.58 million | €2.85 million |
| Net loss | €47.00 million | €33.59 million |
| Basic and diluted loss per share | €1.35 | €1.38 |
| Cash and cash equivalents at year-end | €83.92 million | €119.15 million |
| Operating cash flow | €(29.87) million | €(27.54) million |
| Total financial liabilities | €46.02 million | €48.98 million |
| Total shareholders’ equity | €26.79 million | €70.47 million |
The company remained loss-making, with no meaningful operating margin given negligible revenue. The filing reports no product-sales revenue. Cash used in investing activities was €0.24 million; financing cash flow was €(5.18) million, compared with €111.77 million provided in 2020, mainly reflecting the prior-year equity offerings. Cash declined by €35.23 million during 2021.
Material changes versus 2020
- Operating loss widened by approximately €16.15 million. R&D expense rose 25%, chiefly as clinical activity increased, including preparation of NANORAY-312; SG&A rose 33%, including public-company, legal, partnership and recruitment costs.
- Net loss increased by €13.41 million despite higher net financial income. The 2021 result included €6.35 million of foreign-exchange gains, principally associated with U.S.-dollar funds.
- Cash fell by €35.23 million. The LianBio upfront payment was collected, but the company also paid PharmaEngine €6.5 million under the termination agreement, repaid debt and funded operations.
- Current liabilities increased to €36.85 million from €19.04 million, including €16.52 million of deferred revenue/contract liabilities related to LianBio. Under the company’s IFRS 15 accounting, the upfront payment is an advance against future product supply, not recognized as 2021 revenue.
- Financial liabilities declined overall to €46.02 million from €48.98 million. The EIB’s third €10 million loan tranche was not drawn because conditions were not met by the July 2021 deadline.
Outlook, commentary and risks
- Management estimated year-end cash would fund current operations through the second quarter of 2023, while stating that additional capital would be needed to advance development, pursue regulatory requirements and commercialize candidates. The estimate depends on assumptions and could prove incorrect.
- NANORAY-312, a global Phase III trial in elderly head and neck cancer patients ineligible for platinum-based chemotherapy, opened European sites in Q4 2021; its first patient was randomized in January 2022. The company expected U.S. and Asian site activation and enrollment to begin in 2022.
- Study 102 expansion results were preliminary: the September 2021 analysis reported median overall survival of 18.1 months and median progression-free survival of 10.6 months in 41 evaluable patients. The filing also reports a February 2022 analysis of 23 months median overall survival in 44 evaluable patients. The study was not a registration trial; results require confirmation.
- Management disclosed a potentially NBTXR3-, radiotherapy- and cancer-related sepsis death in Study 102. The filing also describes serious adverse events in clinical studies; efficacy and safety remain subject to further testing.
- COVID-19 had delayed enrollment, monitoring and data collection in some trials. Russia’s invasion of Ukraine could require replacement of planned NANORAY-312 sites; the filing said no significant delay had been identified as of its publication, but delay could not be excluded.
- Other material risks include dependence on NBTXR3, clinical and regulatory uncertainty, manufacturing and supplier constraints, reimbursement and market adoption, competition, and the need for additional funding. EIB loan covenants restrict certain financing, acquisitions, asset disposals and other actions.
- The PharmaEngine collaboration ended by mutual agreement in March 2021. Nanobiotix paid €5.4 million in 2021 and may owe further payments, including $1 million on receipt of certain study reports, $5 million upon a second regulatory approval, and low-single-digit regional royalties if sales occur.
- A material weakness in controls over clinical-contract expense timing was identified in interim 2021 reporting and remediated during the year. Management concluded internal control over financial reporting was effective at December 31, 2021; the auditor did not provide an opinion on internal-control effectiveness.
Most important facts for investors to verify
- Cash runway assumptions and timing and terms of any additional financing.
- NANORAY-312 enrollment progress, trial milestones and any effects from site replacement or recruitment delays.
- Whether Study 102 and Study 1100 preliminary efficacy and safety findings are confirmed in larger or controlled studies.
- Commercial plans for EU-approved Hensify, including whether the company will invest in commercialization or prioritize other indications.
- Debt repayment schedule, EIB royalty obligations and restrictive covenants; also the conditions for PharmaEngine contingent payments.
- Recognition and release timing of the €16.52 million LianBio contract liability, and the conditions attached to potential milestone and royalty income.