InflaRx N.V. — FY2021 Form 20-F
Reporting period: Fiscal year ended December 31, 2021. This is an annual report, not a standalone Q4 filing. InflaRx is a clinical-stage biopharmaceutical company developing complement-targeting therapies. Financial statements are prepared under IFRS in euros.
Financial and operating summary
| Metric | FY2021 | FY2020 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | €35.7 million | €25.7 million |
| General and administrative expense | €12.0 million | €8.5 million |
| Operating loss | €47.6 million | €33.9 million |
| Net loss | €45.6 million | €34.0 million |
| Basic and diluted loss per share | €1.10 | €1.26 |
| Net cash used in operating activities | €39.9 million | €36.5 million |
| Cash and cash equivalents at year-end | €26.2 million | €26.0 million |
| Marketable securities at year-end | €83.7 million | €54.3 million, as stated in management discussion |
Margins are not meaningful because the company had no product revenue. The net loss widened by €11.6 million year over year, primarily as R&D spending rose, especially third-party clinical and manufacturing costs. The 2021 loss was partly offset by a positive €2.0 million net financial result, mainly reflecting foreign-exchange gains; these gains may not be realized. Total comprehensive loss was €38.9 million, including a €6.8 million favorable currency translation adjustment.
Investing activities used €26.0 million, largely reflecting purchases of financial assets net of maturities. Financing activities provided €61.6 million, principally from the March 2021 share offering and at-the-market issuance. Total assets were €125.1 million and equity was €105.3 million at year-end. The company reported no financial borrowings; lease liabilities totaled €1.4 million. Current liabilities were €18.8 million, including €8.3 million of grant funds received but deferred pending eligible costs and grant-condition certainty.
Material changes and business developments
- R&D expense increased €10.0 million and G&A expense increased €3.5 million versus 2020. Share-based compensation contributed to higher personnel costs in both categories.
- InflaRx raised $75.0 million gross in a public offering of 15.0 million shares in March 2021, with one warrant per share at a $5.80 exercise price. No warrants were exercised before their March 1, 2022 expiry. Year-end common shares outstanding were 44,203,763.
- The company received €8.3 million under a German government grant of up to €43.7 million for COVID-19 development and manufacturing. Reimbursement is conditional, generally covers 80% of specified eligible expenses, and later tranches depend on milestones. The received amount was recorded as a liability, not income, at year-end because eligibility and conditions remained uncertain.
- Management said cash, cash equivalents and financial assets were expected to fund the current business plan for at least 24 months from December 31, 2021. This is an estimate, not a guarantee; management also said additional funding will be needed to continue development and potentially commercialize products.
Outlook, commentary, risks and unusual items
- Pipeline: Vilobelimab is the lead intravenous anti-C5a antibody, being developed for severe COVID-19, hidradenitis suppurativa (HS), ANCA-associated vasculitis (AAV), pyoderma gangrenosum (PG) and cutaneous squamous cell carcinoma (cSCC). INF904, an oral C5a-receptor inhibitor, was planned to enter Phase I in the second half of 2022; IFX002 remained preclinical.
- COVID-19: The Phase III trial in 369 mechanically ventilated patients was fully enrolled. Its primary endpoint was 28-day all-cause mortality; topline results were expected in Q1 2022. The interim monitoring committee recommended continuing the study. Phase II mortality results were exploratory and not powered to establish statistical efficacy.
- HS: The prior Phase IIb study did not meet its primary endpoint. A Phase III study initiated in January 2022 was paused in February after conflicting FDA advice on the primary endpoint. A corrected FDA letter in March 2022 gave recommendations on implementing modified HiSCR; the company was evaluating next steps. These events occurred after the fiscal year-end.
- AAV and PG: The company reported Phase II data indicating comparable clinical response with reduced glucocorticoid use in the EU AAV study, and preliminary remission in six of seven patients in the highest-dose PG cohort. These findings require further evaluation and are not evidence of regulatory approval or definitive efficacy.
- Funding and operating risks: InflaRx has a history of significant losses, no commercial product or product revenue, and expects continued losses. Clinical success, regulatory approval, reimbursement, manufacturing scale-up and additional financing are uncertain. The company depends on third-party manufacturers, including a principal vilobelimab supplier in China, and on CROs; COVID-related enrollment and supply disruptions were identified as risks.
- Currency exposure: The company held substantial U.S.-dollar assets and had no hedging arrangements. It reported a sensitivity of approximately €1 million higher or €2 million lower loss for a 10% weakening or strengthening of the euro against the dollar, respectively.
- Other notable disclosures: No cash dividends are anticipated in the foreseeable future. Management concluded disclosure controls and internal control over financial reporting were effective as of year-end; the filing did not include an auditor attestation of internal controls. The company disclosed no material litigation during the period.
Most important facts for investors to verify
- Confirm the COVID-19 Phase III topline results and any subsequent regulatory filings or decisions; the filing only provided an expected Q1 2022 readout.
- Check the current HS Phase III plan, FDA alignment on modified HiSCR, and implications of the earlier Phase IIb primary-endpoint miss.
- Reconcile year-end liquidity across cash, marketable securities and other financial assets, and assess actual cash burn against management’s 24-month runway estimate.
- Track whether grant expenses qualify for reimbursement, whether further grant milestones are achieved, and whether any funds must be repaid.
- Review the latest clinical and safety data for AAV, PG and cSCC, as well as financing needs, share dilution and manufacturing-transfer progress.