InflaRx N.V. — FY2023 Form 20-F
Reporting period: Fiscal year ended December 31, 2023; filed March 21, 2024. This is an annual report, not a standalone Q4 report. Financial statements are prepared under IFRS as issued by the IASB and presented in euros.
Business context and financial performance
InflaRx is a clinical-stage biopharmaceutical company developing complement inhibitors. Its lead antibody, vilobelimab, received U.S. FDA Emergency Use Authorization (EUA) in April 2023 as GOHIBIC for certain critically ill COVID-19 patients. The company began U.S. commercialization in June 2023. INF904, an oral C5aR inhibitor, and IFX002, a follow-on antibody, remain in development.
| Metric | FY2023 | FY2022 |
|---|---|---|
| Revenue | €0.063 million | None |
| Cost of sales / gross profit (loss) | €0.532 million / (€0.469 million) | None / — |
| Research and development expense | €41.0 million | €37.5 million |
| Sales and marketing expense | €4.0 million | None |
| General and administrative expense | €12.6 million | €14.9 million |
| Operating loss | €44.9 million | €32.2 million |
| Net loss | €42.7 million | €29.5 million |
| Basic and diluted loss per share | €0.78 | €0.67 |
| Net cash used in operating activities | €37.8 million | €33.7 million |
Revenue was the company’s first product revenue, recognized on sales to U.S. hospitals; shipments to distributors are not recognized as revenue until hospital sales occur. Cost of sales included approximately €0.5 million of inventory write-downs, mainly for product expected to expire before sale. The reported gross margin was negative.
Net loss widened by €13.2 million. R&D spending increased, while new commercialization added €4.0 million of sales and marketing expense. Other income, primarily German government grant income, declined to €13.2 million from €20.2 million as eligible spending fell and the grant period ended. Net financial result was €2.2 million, including €3.8 million interest income and a €1.8 million foreign-exchange loss.
Financial position, cash flow and funding
- At year-end, cash and cash equivalents were €12.8 million and marketable securities were approximately €85.6 million; the financial statements show €85.7 million of current and non-current securities. The company reported total available funds of €99.4 million including other financial assets.
- Operating cash use was €37.8 million. Investing activities used €17.7 million, mainly reflecting net purchases of marketable securities; financing activities provided €53.0 million, principally from equity offerings and the at-the-market program.
- Total assets were €120.2 million, equity €102.6 million and total liabilities €17.6 million. The company reported no borrowings; liabilities included €1.12 million of lease liabilities. Trade and other payables were €12.0 million on the balance sheet.
- April 2023’s underwritten offering generated €38.7 million net proceeds. The ATM program generated €14.4 million net proceeds in 2023 and expired in July. Year-end ordinary shares outstanding were 58,883,272, up from 44,703,763 a year earlier.
- Management said available cash, cash equivalents and financial assets should fund the current business plan for at least 24 months from year-end 2023. It also expects to need substantial additional funding; no committed external funding source was disclosed.
Material changes and outlook
- Commercial launch: GOHIBIC sales began in the United States under the EUA, but FY2023 recognized revenue was only €63,089. The NIH guidelines stated evidence was insufficient to recommend for or against vilobelimab, which the company said negatively affected hospital adoption.
- COVID-19 evidence and regulation: The PANAMO Phase III trial reported a 23.9% relative reduction in 28-day mortality, but the primary site-stratified analysis was not statistically significant (p=0.094). A prespecified Western European subgroup showed a 43% relative reduction (p=0.014). The FDA granted the EUA; the European MAA was validated in August 2023 and remained under review. The company said a broader FDA BLA pathway would require an additional adequately powered study and that it was evaluating funding and collaboration options.
- Pipeline priorities: The first patient entered the vilobelimab Phase III ulcerative pyoderma gangrenosum (PG) study in November 2023; management projected enrollment would take at least two years. Development in cutaneous squamous cell carcinoma (cSCC) was wound down in November 2023, with no new enrollment, to prioritize INF904. Vilobelimab development in hidradenitis suppurativa and ANCA-associated vasculitis was on hold while the company evaluated next steps, including partnerships.
- INF904 outlook: The filing reports positive Phase I single- and multiple-ascending-dose results announced through January 2024, after the fiscal year-end. The company planned a short-term Phase II study toward year-end 2024 and a longer-term Phase II study in 2025, subject to completing further nonclinical work and formulation development.
- Risks and unusual items: The €33.3 million German grant was reimbursement for specified development and manufacturing costs; authorities may audit compliance and seek repayment in certain circumstances. Grant-funded IP can also carry government-use and licensing conditions. Inventory valuation depends on uncertain demand, shelf life and regulatory outcomes; €10.6 million of unfinished GOHIBIC inventory was a critical audit matter. The auditor also identified estimation of clinical and manufacturing vendor costs as a critical audit matter. EY issued unqualified opinions on the financial statements and internal controls.
Investor verification priorities
- Confirm hospital-level GOHIBIC orders, recognized sales, returns/rebates and inventory expiry exposure; revenue remains minimal relative to commercialization costs.
- Track EUA conditions and duration, the EU MAA decision, and the design, funding and timing of the additional study needed for a broader BLA pathway.
- Assess the clinical and regulatory evidence for the PG Phase III trial and INF904 Phase II plans, including whether timelines and enrollment assumptions remain achievable.
- Reconcile cash burn and the stated 24-month runway against current spending plans, grant expiration, and any financing or collaboration announcements; consider dilution risk.
- Review inventory valuation assumptions, potential grant repayment or IP obligations, and foreign-exchange exposure; the company reported no currency hedging.