InflaRx Q2 2024 Financial Results and Business Update

InflaRx N.V., a biopharmaceutical company at the forefront of anti-inflammatory therapeutics, has announced its financial results for the first half of 2024 and provided significant updates on its operational progress. The company is pioneering treatments in immunology and inflammation, focusing on diseases with substantial unmet medical needs.

InflaRx is preparing to initiate a Phase 2a study of INF904 in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) by the end of 2024. This study aims to evaluate the safety and pharmacokinetics of multiple dosing regimens over four weeks in patients with moderate-to-severe CSU and HS. The study will involve 75 patients across various centers. The first data readout from this Phase 2a trial is anticipated in the summer of 2025, with a Phase 2b trial expected to commence later that same year. The company believes that INF904 could potentially address markets with annual revenue of over $1 billion per indication.

InflaRx is also advancing its late-stage clinical development of vilobelimab for pyoderma gangrenosum (PG), a severe inflammatory skin condition with no approved treatments in the U.S. or Europe. The Phase 3 trial for vilobelimab, which began in November 2023, involves a randomized, double-blind, placebo-controlled study. The study will compare vilobelimab combined with corticosteroids against a placebo combination. The primary endpoint is the complete closure of the target ulcer within 26 weeks of treatment initiation. An interim analysis of this trial is expected in 2025, which will help determine the final trial size or whether to halt the study due to lack of efficacy.

Vilobelimab has been granted orphan drug designation by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of PG. Moreover, it has received fast track designation from the FDA, underscoring its potential in addressing significant medical needs.

The company has also announced that vilobelimab, marketed as GOHIBIC, has been selected by the Biomedical Advanced Research and Development Authority (BARDA) for inclusion in a Phase 2 clinical trial aimed at evaluating host-directed therapeutics for acute respiratory distress syndrome (ARDS). This trial will involve approximately 600 hospitalized adults across 60 U.S. sites, with the primary endpoint being all-cause mortality at Day 28. The data from this study will inform the design of subsequent Phase 3 trials.

In financial terms, InflaRx reported revenues from product sales of GOHIBIC amounting to €42,000 for the first half of 2024. The company’s cash, cash equivalents, and marketable securities totaled €74.6 million as of June 30, 2024, which is expected to fund operations through 2026. Despite a net loss of €23.5 million for the first six months of 2024, the company maintains a strong financial position to support its ongoing and future clinical programs.

Sales and marketing expenses increased by €3.0 million compared to the same period in 2023, primarily due to heightened activities following the emergency use authorization (EUA) for GOHIBIC in Q2 2023. Research and development (R&D) expenses saw a decrease of €8.3 million, reflecting lower third-party costs related to commercial manufacturing processes and EUA efforts from the previous year. However, personnel expenses increased by €1.2 million, primarily due to higher stock-based compensation.

General and administrative expenses slightly decreased to €6.8 million for the first half of 2024, while other income dropped significantly to €53,000 due to the end of a government grant period. The net financial result improved by €3.2 million, driven mainly by a higher foreign exchange gain.

Overall, InflaRx continues to make significant strides in its R&D efforts, with promising upcoming milestones for both INF904 and vilobelimab. The company remains well-capitalized to advance its clinical programs and address substantial unmet needs in the field of inflammation and immunology.