Tuesday, November 3
InflaRx N.V.
The business
InflaRx goes into its Capital Markets Day as a company with no product revenue and a new lead plan. Over the last four quarters it stopped selling GOHIBIC (vilobelimab) in the United States, restructured in January 2026 to put its resources mainly into the oral drug izicopan, moved izicopan's development toward ANCA-associated vasculitis (AAV) and selected kidney diseases, and raised money in May. Management now expects that cash to fund operations and clinical development through 2029, against mid-2027 in March, and it is aiming for first data from kidney-disease proof-of-concept studies in 2027.
As described in its 20-F, InflaRx is a biopharmaceutical company based in Jena, Germany. It discovers and develops inhibitors of C5a, a factor that switches on the complement system, and of C5a's receptor, C5aR. Its lead candidate, izicopan (formerly INF904), is a small molecule taken by mouth that blocks C5aR1. In November 2025 the company reported positive Phase 2a data for izicopan in hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU). Vilobelimab is an antibody given by infusion that binds free C5a. In April 2023 the FDA granted it an Emergency Use Authorization for critically ill, mechanically ventilated COVID-19 patients, and in January 2025 it received a European Commission marketing authorization under exceptional circumstances. In the U.S. it was sold to hospitals under the GOHIBIC name. Vilobelimab is also being tested in a BARDA-funded Phase 2 platform study in broader ARDS (acute respiratory distress syndrome). IFX002, a second anti-C5a antibody, is in preclinical development as a successor to vilobelimab. The company had 65 employees at December 31, 2025, and 51 as of the filing date.
The last four quarters
| As reported | Q3 2025 | Q4 2025 | Q1 2026 | Q2 2026 | LTM |
|---|---|---|---|---|---|
| Source | Statements | Release | Statements | Release | |
| Revenue (€m) | 0.0 | — | — | — | — |
| IFRS operating income (€m) | (9.5) | — | (7.2) | (7.1) | — |
| IFRS net income (€m) | (12.3) | — | (5.6) | (10.6) | — |
| IFRS diluted EPS (€) | (0.18) | — | (0.08) | (0.09) | — |
| IFRS Research and development expenses (€m) | (6.2) | — | (4.2) | (4.7) | — |
| IFRS General and administrative expenses (€m) | (2.6) | — | (3.2) | (2.5) | — |
From the company's quarterly earnings releases, and its interim financial statements where the column says so. Non-GAAP rows are from the earnings releases.
Guidance on record
On August 6, 2026 the company said:
- It expects its cash, cash equivalents and marketable securities, including the net proceeds of the May offering, to fund ongoing operations and clinical development through 2029, extended from mid-2027 in March.
- It expects to start a pharmacokinetic bridging study of izicopan in China late this year, to speed up proof-of-concept studies in additional inflammation and immunology indications in China and elsewhere.
- It plans to develop izicopan in AAV; Phase 2 planning is continuing as planned.
- It plans open-label proof-of-concept studies of izicopan in atypical hemolytic uremic syndrome (aHUS), IgA nephropathy (IgAN) and C3 glomerulopathy (C3G), with the goal of producing initial data in 2027.
- It intends to engage with the European Medicines Agency on vilobelimab and izicopan to evaluate a path to approval in AAV in Europe, and it is evaluating several development approaches in AAV, including a possible expedited path to market in the United States and Europe.
- It intends to use the offering proceeds to advance its pipeline, including development in AAV and selected renal diseases, and for working capital and general corporate purposes.
On March 19, 2026 the company said:
- It targets release of the complete izicopan Phase 2a results at major scientific meetings this year.
- It expects to close out communications with the FDA on a Phase 2b trial of izicopan in HS in the upcoming months.
- It anticipates meeting the FDA to determine a possible development path for vilobelimab in pyoderma gangrenosum, and expects any future development in that disease to be conducted only with a partner.
Recent developments
On October 22, 2026 the company said:
- New preclinical data on izicopan were presented at the American Society of Nephrology's Kidney Week 2026 in Denver.
- In two hamster models of kidney injury, renal ischemia-reperfusion injury and unilateral ureteral obstruction, oral izicopan significantly reduced renal injury compared with vehicle-treated controls.
- Structural modeling compared izicopan with avacopan and gave a molecular explanation for izicopan's low potential for time-dependent inhibition of CYP3A4/5.
On August 6, 2026 the company said:
- In May it priced an underwritten registered direct offering of 75,000,000 ordinary shares at $2.00 each, for net proceeds of €119.3 million ($140.4 million).
- In May it announced that it intends to develop izicopan in AAV and that it is targeting renal diseases including aHUS, IgAN and C3G.
- It began assessing the feasibility of a broader strategy for AAV in Europe. This followed the June recommendation by the European Medicines Agency's CHMP committee to revoke the EU marketing authorization of Tavneos (avacopan).
- New in vitro data released in April and May showed that izicopan does not cause time-dependent inhibition of CYP3A4 and forms fewer reactive metabolites in human liver microsomes than avacopan.
- It announced a virtual Capital Markets Day for October 8, 2026, to cover its AAV development strategy and izicopan's profile.