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InflaRx N.V. Company History

History

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 initiates Phase IIb/III trial with vilobelimab in patients with severe COVID-19 induced pneumonia.  Based on promising results from the Phase IIb part of the trial, the Company initiates the Phase III part, which is currently ongoing.

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.

In the Third Cohort, 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.

InflaRx initiated a Phase III program with vilobelimab in hidradenitis suppurativa (HS) patients with active draining tunnels. The new primary endpoint, called modified HiSCR, as suggested by the FDA, will include measuring the reduction of all three types of lesions.

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