InflaRx Announces Q3 2024 Financial Results and Business Update

InflaRx N.V., a biopharmaceutical company listed on Nasdaq under the ticker IFRX, recently published its financial results for the third quarter of 2024, highlighting substantial advancements and providing an operational update. The company’s CEO and Founder, Prof. Niels C. Riedemann, emphasized the significant progress achieved, particularly in complement inhibition, stating that the company is well-positioned for upcoming milestones.

In terms of clinical trials, InflaRx marked a notable milestone by recruiting 30 patients for their Phase 3 vilobelimab trial targeting pyoderma gangrenosum (PG). This recruitment is crucial as it paves the way for an interim analysis expected by the end of the second quarter of 2025. Additionally, the company is set to commence a Phase 2a trial for INF904 by the end of 2024, with the first data readout anticipated in the summer of 2025. The European Committee for Medicinal Products for Human Use (CHMP) is also reviewing vilobelimab, with a decision expected around mid-November 2024.

Financially, InflaRx reported revenues of €166,000 from GOHIBIC (vilobelimab) sales for the nine months ending September 30, 2024. This revenue was exclusively generated from sales in the United States. However, the company also incurred a net loss of €41.0 million during the same period, primarily due to a decline in other income following the conclusion of the German government grant in mid-2023. The company's expenses included increased sales and marketing expenses by €3.2 million, attributed largely to GOHIBIC, and a reduction in R&D expenses by €4.5 million compared to the previous year. Nevertheless, the decrease in R&D costs was balanced by a rise in personnel expenses due to heightened stock-based compensation.

InflaRx maintains a strong liquidity position with €62.0 million in cash, cash equivalents, and marketable securities, projected to support operations into 2026. This financial stability is vital as the company progresses with its clinical trials and potential product launches. The company has also actively participated in multiple medical congresses, presenting new findings on INF904, which exhibited advantageous anti-inflammatory and pharmacokinetic properties.

INF904, an oral C5aR inhibitor, has shown promising results in preclinical studies, targeting chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The forthcoming Phase 2a trial will involve 75 patients across multiple centers, assessing various dosing regimens over a four-week treatment period. This study aims to generate additional safety and pharmacokinetic data and provide insights into the clinical benefits, potentially informing a subsequent Phase 2b trial scheduled for late 2025. InflaRx estimates that both CSU and HS represent significant market opportunities, potentially exceeding $1 billion in addressable markets.

Vilobelimab's Phase 3 trial for PG, initiated in November 2023, is designed as a multi-national, randomized, double-blind, placebo-controlled study. The primary endpoint is the complete closure of the target ulcer within 26 weeks of treatment. The interim analysis will decide whether to adapt the trial size or cease it due to futility based on predefined criteria.

Additionally, InflaRx continues to engage in medical education programs for GOHIBIC in COVID-19, with presentations at several notable congresses in the U.S. and Asia. The company's commitment to advancing its pipeline, including the development of INF904 and the late-stage trial of vilobelimab, remains strong.

In conclusion, InflaRx’s recent accomplishments and financial health underscore its potential in developing treatments for severe inflammatory conditions. The company’s strategic focus on advancing its clinical programs while maintaining financial prudence positions it well for future growth and value creation.