InflaRx GmbH was founded in December 2007 in Jena, Germany, an internationally recognized acute care clinical trial hub. InflaRx developed close collaborative ties with the Jena University Medical Center, where CEO, Niels Riedemann held the position as Vice Director of Intensive Care Therapy. InflaRx was therefore able to build an in-house team with vast expertise in the acute care and inflammatory disease field.

Simultaneously, CSO, Renfeng Guo expanded the company’s collaborations with the Beijing Institute of Sciences and other renowned Chinese immunologists, allowing InflaRx to conduct top-tier immunological research abroad. These collaborations led to ground-breaking work on the role of C5a in different types of lung injury in non-human primates, and other discoveries.

In 2008, InflaRx made a breakthrough discovery allowing the generation of monoclonal anti-C5a antibodies which are both highly selective (not blocking the terminal membrane attack complex) and have an extremely potent immunologic blocking activity. InflaRx's discoveries were the subject of patent applications globally; since, numerous patents have been issued in various countries.

In 2011, InflaRx started a Phase I clinical trial with an anti-C5a antibody, demonstrating that vilobelimab was safe and well tolerated.

In 2014, InflaRx successfully discovered IFX002, a follow-on molecule of vilobelimab, which has planned development for additional chronic inflammatory diseases.

In 2015, InflaRx completed a Phase IIa trial with vilobelimab in patients suffering from life-threatening infections and early organ dysfunction. This trial validated InflaRx’s vilobelimab technology, demonstrating that C5a can be effectively controlled and blocked by vilobelimab in this setting.

In 2017, InflaRx completed a first clinical Phase IIa open-label single-center study in Hidradenitis Suppurativa (HS) patients, demonstrating a clinical response rate of 83% using the Hidradenitis Clinical Response Score (HISCR) at the end of the trial observation period in 12 patients with Hurley Stage III.

In November 2017, InflaRx completed a successful US IPO with total gross proceeds of USD 106 million on the US Nasdaq global select market after closing a crossover financing round with a total proceeds of USD 55 million.

In April 2018, InflaRx conducted a USD 117 million total gross proceeds follow-on transaction on the US Nasdaq global select market.

InflaRx completed the Phase IIb SHINE Study in HS.  The study did not achieve its primary endpoint (dose dependent effect on the HiSCR at week 16) but the results suggest a robust anti-inflammatory activity in the high dose vilobelimab treatment group across numerous efficacy measures. Additionally, results from open label extension part of trial showed that responders maintain response to a large extent over long term treatment and roughly 42% of non-responders become responders.

InflaRx initiated a Phase IIb/III trial with vilobelimab in patients with severe COVID-19 induced pneumonia.

InflaRx announced the underwritten public offering of 15,000,000 common shares at $5.00 per share. The gross proceeds were approximately $75 million.

InflaRx Awarded up to EUR 43.7 million (~USD 50.7 million) grant by German government to advance the development of vilobelimab for treatment of severe COVID-19.

Six of seven patients achieved clinical remission with a PGA score of ≤1. The entire study enrolled a total of 19 patients across three different dosing cohorts.

In the EU study, vilobelimab reduced the use of corticosteroids in AAV patients and demonstrated comparable efficacy to standard of care. Also, the use of vilobelimab instead of glucocorticoids led to a substantially lower observed glucocorticoid toxicity.  In the US study, the results indicated that vilobelimab, when given in addition to best standard of care, was well tolerated.

Regulatory discussions on Phase I program initiated and the US Patent and Trademark Office granted InflaRx a composition of matter patent.

Phase III portion of the Phase II/III PANAMO study in mechanically ventilated COVID-19 patients showed a relative reduction in 28-day all-cause mortality of 23.9%.

GOHIBIC® (vilobelimab) granted Emergency Use Authorization by the U.S. Food and Drug Administration for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Closing of the full exercise of the greenshoe option, increasing proceeds from the public offering of ordinary shares to US$46 million.

SAD data confirmed best-in-class potential for INF904 as an orally administered C5aR inhibitor. INF904 showed positive safety and tolerability with no signals of concern over entire dose range. There was favorable dose-proportional systemic exposure with an overall PK profile confirming pre-clinical data.

MAD pharmacokinetic and pharmacodynamic data supported best-in-class potential of INF904 over tested dose range of 30 mg once per day to 90 mg twice per day for 14 days. INF904 achieved ≥90% blockade of C5a-induced neutrophil activation over 14-day dosing period and was well tolerated with no safety signals of concern over entire dose range.

INF904 development initially targeted at chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), with initiation of a Phase IIa PK dose-ranging study expected by the end of 2024, and data availability anticipated in 2025.

First patient dosed in the Phase IIa basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company’s oral C5aR inhibitor with best-in-class potential, INF904.

GOHIBIC® (vilobelimab) selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as one of three investigational therapies to be assessed in a Phase II clinical platform study exploring potential new options for the treatment of ARDS.

The European Commission (EC) granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO). At the time, GOHIBIC was the first and only treatment approved in the European Union for the treatment of SARS-CoV-2-induced ARDS.

Closing of the US$30 million public offering of ordinary shares and pre-funded warrants.