InflaRx has reported its Q2 2025 results and provided updates across its pipeline targeting inflammatory diseases.

Data from the Phase 2a basket trial of INF904, an oral C5aR inhibitor, in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) are expected between late September and early November. The study is assessing safety, pharmacokinetics, and signs of clinical benefit across multiple dosing cohorts in 75 patients. Results will inform Phase 2b planning by year-end.

The trial includes three HS dosing groups and two CSU groups, with a third CSU cohort in patients with a Type Iib phenotype still enrolling. InflaRx sees both CSU and HS as potential billion-euro markets and continues to assess other inflammatory disease applications via collaborations.

In respiratory disease, enrollment has begun in the BARDA-funded JUST BREATHE Phase 2 trial investigating vilobelimab and other novel candidates in acute respiratory distress syndrome (ARDS). Vilobelimab already holds EU approval, under exceptional circumstances, for COVID-19-induced ARDS in ventilated patients.

The company will unblind its halted Phase 3 trial of vilobelimab in pyoderma gangrenosum (PG) later this year after a futility recommendation from the independent monitoring committee.

In July, Chinese partner Staidson BioPharmaceuticals reported positive Phase 1/2 data for BDB-001, an anti-C5a antibody, in ANCA-associated vasculitis (AAV). The study met its primary and key secondary endpoints, and Staidson plans to advance into Phase 3. InflaRx will receive royalties on future AAV sales under their co-development deal.

Financial performance

For the six months to 30 June 2025, InflaRx posted revenues of €39,000, all from US vilobelimab sales, versus €42,000 in 2024. Net loss was €23.0 million, slightly improved from €23.5 million.

R&D expenses fell to €14.2 million from €17.3 million, sales and marketing costs decreased to €2.5 million, and G&A costs rose to €8.3 million. Cash, cash equivalents, and marketable securities totalled €53.7 million at quarter end, expected to fund operations into 2027. The company is reviewing allocation of further resources to the INF904 programme.