Annuncio • Jun 30

InflaRx Assesses Feasibility Of Broadened Strategy For ANCA-Associated Vasculitis In Europe Following EMA Recommendation On Tavneos

InflaRx N.V. announced it is assessing the feasibility of broadening its development and registrational strategy for ANCA-associated vasculitis (AAV) in Europe. The company has initiated this assessment given the recommendation of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to revoke the marketing authorization for Tavneos in the European Union, announced on June 26, 2026. The Company announced it intends to engage with EMA regarding both its anti-C5a antibody vilobelimab, which is approved under exceptional circumstances as GOHIBIC in Europe for SARS-CoV-2-induced acute respiratory distress syndrome, in addition to its next-generation oral C5aR inhibitor izicopan. This will be part of the Company’s overall development goal to determine the most efficient development pathway to bring the C5a/C5aR inhibition mechanism to patients. The previously announced Phase 2 planning with izicopan in AAV continues as planned and uninterrupted across multiple geographies. InflaRx considers vilobelimab to be a Phase 3-ready asset in AAV, where it has completed two Phase 2 studies in the U.S. and Europe. In addition, BDB-001, a vilobelimab cell line-produced antibody, has completed Phase 2 development and is being evaluated by InflaRx’s collaborator, Staidson BioPharmaceuticals Co. Ltd. (Staidson), in a Phase 3 trial in AAV in China. Together, vilobelimab and izicopan provide InflaRx with a complementary biologic and oral pipeline that is well positioned to address the evolving treatment landscape and significant unmet medical need in AAV. A growing body of clinical data supporting the utility and safety of anti-C5a therapy in AAV has emerged in recent years. Vilobelimab has been evaluated in two controlled Phase 2 AAV studies, the European IXCHANGE trial (NCT03895801) and the U.S. IXPLORE trial (NCT03712345). In IXCHANGE, which tested vilobelimab as a replacement for glucocorticoids on a background of standard-of-care rituximab or cyclophosphamide, clinical response and remission rates with vilobelimab were comparable to those achieved with standard-dose glucocorticoids, while cumulative glucocorticoid exposure and glucocorticoid-related toxicity were substantially lower in vilobelimab-treated patients. In IXPLORE, vilobelimab added to standard of care was well tolerated without signals of safety concerns. Across both IXCHANGE and IXPLORE, vilobelimab demonstrated a favorable safety and tolerability profile, with IXCHANGE supporting its potential to induce remission while markedly reducing the glucocorticoid burden. In addition, under a license agreement where it holds development and commercialization rights in China, our collaborator Staidson has generated promising AAV data with BDB-001, an anti-C5a antibody produced using the vilobelimab cell line. The multicenter, randomized, open-label, parallel-controlled Phase 1/2 clinical trial by Staidson demonstrated that BDB-001 injection combined with reduced-dose glucocorticoids or without glucocorticoids achieved comparable partial response rates and numerically higher complete response rates at 12 weeks of treatment compared with standard of care using the Birmingham vasculitis score (BVAS). After successful completion of this Phase 1/2 study, Staidson initiated a Phase 3 trial in China in 2025, which is ongoing. AAV is a rare, life-threatening autoimmune disease characterized by inflammation and damage to small blood vessels, with patients often experiencing serious organ involvement, including renal impairment. InflaRx believes the recent regulatory developments underscore the continued need for well-characterized, mechanistically targeted therapies that may help address the significant unmet medical need in this disease. Izicopan is an orally administered, small molecule inhibitor of the C5a receptor (C5aR) that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan does not exhibit time-dependent inhibition of cytochrome P450 3A4 (CYP3A4), which plays an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Izicopan has also demonstrated a favorable reactive metabolite profile in human liver microsomes. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic /pharmacodynamic data support the best-in-class potential of izicopan, with a =90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules and draining tunnels, robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7). In addition, InflaRx is planning for development of izicopan in AAV and additional renal indications. Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances 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)). The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units.

Percentuale dello stipendio del CEO	n/a
Mandato del CEO	19.5yrs
Proprietà del CEO	0.7%
Durata media del management	4yrs
Durata media del Consiglio di amministrazione	7.2yrs

Nome	Posizione	Mandato	Compensazione	Proprietà
Niels Riedemann	Co-Founder	19.5yrs	Nessun dato	0.73% € 2.0m
Renfeng Guo	Co-Founder	19.5yrs	Nessun dato	1.2% € 3.3m
Thomas Taapken	Chief Financial Officer	5.8yrs	Nessun dato	0.0024% € 6.5k
Derval O'Carroll	Senior VP and Global Head of Regulatory Affairs & Compliance	3.3yrs	Nessun dato	Nessun dato
Jan Medina	Head of Investor Relations & VP	2.4yrs	Nessun dato	Nessun dato
Christian Schmid	VP and Head of Legal Affairs & General Counsel	no data	Nessun dato	Nessun dato
Maria Habel	VP, Head of Preclinical R&D and QC	13.5yrs	Nessun dato	Nessun dato
Kofi Boaten	VP and Head of Supply Quality & Clinical Trial Supplies	no data	Nessun dato	Nessun dato
Peter Hurt	Senior Director and Head of Drug Safety & Pharmacovigiliance	no data	Nessun dato	Nessun dato
Daniel Vetter	Senior Director & Head of IT	4yrs	Nessun dato	Nessun dato
Igor Orshanskiy	Senior Director & Head of Business Development	2.7yrs	Nessun dato	Nessun dato
Kirsten Cremering	Senior Director & Head of Quality Assurance	2.3yrs	Nessun dato	Nessun dato

Nome	Posizione	Mandato	Compensazione	Proprietà
Niels Riedemann	Co-Founder	no data	Nessun dato	0.73% € 2.0m
Renfeng Guo	Co-Founder	no data	Nessun dato	1.2% € 3.3m
Nicolas Fulpius	Independent Chairman of the Board	19.5yrs	Nessun dato	0.33% € 909.3k
K. Reinhart	Member of Scientific Advisory Board	no data	Nessun dato	Nessun dato
P. Ward	Member of Scientific Advisory Board	no data	Nessun dato	Nessun dato
Richard Brudnick	Independent Non-Executive Director	7.2yrs	Nessun dato	0.034% € 92.8k
Hege Hellstrom	Non-Executive Director	3.3yrs	Nessun dato	Nessun dato
Mark Kubler	Independent Non-Executive Director	11.5yrs	Nessun dato	0.65% € 1.8m
Anthony Gibney	Independent Non-Executive Director	5.2yrs	Nessun dato	0.0068% € 18.6k

Dati	Ultimo aggiornamento (ora UTC)
Analisi dell'azienda	2026/07/08 10:23
Prezzo dell'azione a fine giornata	2026/07/08 00:00
Utili	2026/03/31
Utili annuali	2025/12/31

Pacchetto	Dati	Tempistica	Esempio Fonte USA ^*
Dati finanziari della società	10 anni	Conto economico Rendiconto finanziario Bilancio	Modulo SEC 10-K Modulo SEC 10-Q
Stime di consenso degli analisti	+3 anni	Previsioni finanziarie Obiettivi di prezzo degli analisti	Rapporti di ricerca degli analisti Blue Matrix
Prezzi di mercato	30 anni	Prezzi delle azioni Dividendi, scissioni e azioni	Dati di mercato ICE Modulo SEC S-1
Proprietà	10 anni	Top azionisti Insider trading	Modulo 4 SEC Modulo 13D SEC
Gestione	10 anni	Team di leadership Consiglio di amministrazione	Modulo SEC 10-K Modulo SEC DEF 14A
Sviluppi principali	10 anni	Annunci aziendali	Modulo 8-K SEC

Analista	Istituzione
Madhu Kumar	Baird
Mayur Somaiya	BMO Capital Markets Equity Research
Madhu Kumar	B. Riley Securities, Inc.

InflaRx Gestione

Criteri Gestione verificati 2/4

Informazioni chiave

Aggiornamenti recenti sulla gestione

Insufficient new directors

InflaRx N.V., Annual General Meeting, Apr 23, 2026

InflaRx N.V., Annual General Meeting, Apr 24, 2025

InflaRx N.V., Annual General Meeting, Apr 25, 2024

InflaRx N.V. Appoints Jan Medina as Head of Investor Relations

Inflarx N.V. Appoints Camilla Chong as Chief Medical Officer, Effective July 1, 2023

Recent updates

InflaRx Assesses Feasibility Of Broadened Strategy For ANCA-Associated Vasculitis In Europe Following EMA Recommendation On Tavneos

Insufficient new directors

InflaRx N.V. Advances Izicopan in ANCA-Associated Vasculitis and Select Renal Diseases

InflaRx N.V. has completed a Follow-on Equity Offering in the amount of $150 million.

InflaRx N.V. Reports Favorable Reactive Metabolite Profile for Izicopan in Human Liver Microsomes

InflaRx N.V. to Report Q1, 2026 Results on May 07, 2026

InflaRx N.V. Reports New Mechanistic Data For Izicopan Supporting Its Potential As A Best-In-Class C5aR Inhibitor

InflaRx N.V., Annual General Meeting, Apr 23, 2026

Inflarx N.V. Highlights Clinical Activity of Vilobelimab in Pyoderma Gangrenosum

InflaRx N.V. to Report Q4, 2025 Results on Mar 19, 2026

InflaRx N.V. Announces It Is Undertaking Measures to Reduce Spending, Extend the Company’S Cash Runway, and Align Resources to Enable Further Development of Izicopan in HS and Other I&I Indications as a Potential Best-In-Class C5aR Inhibitor and Pipeline-in-a-Product

InflaRx N.V. Provides Update on Phase 3 Data Analyses for Vilobelimab in Pyoderma Gangrenosum

InflaRx N.V. Reports Positive Phase 2a Data for INF904 in Hidradenitis Suppurative (HS) and Chronic Spontaneous Urticaria (CSU)

InflaRx N.V. to Report Q3, 2025 Results on Nov 10, 2025

InflaRx Regains Compliance with Nasdaq Minimum Bid Price Requirement

InflaRx N.V. to Report Q2, 2025 Results on Aug 07, 2025

Inflarx N.V. Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum

InflaRx N.V. to Report Q1, 2025 Results on May 07, 2025

InflaRx N.V., Annual General Meeting, Apr 24, 2025

InflaRx N.V. to Report Q4, 2024 Results on Mar 20, 2025

InflaRx N.V. has completed a Follow-on Equity Offering in the amount of $30 million.

InflaRx N.V. has filed a Follow-on Equity Offering.

InflaRx N.V. Receives European Commission Approval for GOHIBIC®? (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome

Forecast to breakeven in 2027

Inflarx N.V. Announces First Patient Dosed in Phase 2A Study for Oral C5aR Inhibitor INF904

InflaRx N.V. Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome

InflaRx N.V. to Report Q3, 2024 Results on Nov 08, 2024

New major risk - Revenue and earnings growth

InflaRx N.V. to Report Q2, 2024 Results on Aug 08, 2024

Inflarx’S Gohibic (Vilobelimab) Selected for First Barda-Sponsored Clinical Trial to Evaluate Novel Host-Directed Therapeutics for Acute Respiratory Distress Syndrome (Ards)

InflaRx N.V. Hosts R&D Event Highlighting the Promise of INF904

InflaRx N.V. to Report Q1, 2024 Results on May 08, 2024

InflaRx N.V., Annual General Meeting, Apr 25, 2024

No longer forecast to breakeven

InflaRx N.V. to Report Q4, 2023 Results on Mar 21, 2024

InflaRx N.V. Appoints Jan Medina as Head of Investor Relations

InflaRx N.V. Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum

New major risk - Financial position

New minor risk - Market cap size

InflaRx N.V. Announces Positive Topline Results from the Single Ascending Dose (SAD) Phase I Study with C5aR Inhibitor INF904

Inflarx N.V.'S Marketing Authorization Application (Maa) for Vilobelimab for Treatment of Critically Ill Covid-19 Patients Under Review by European Medicines Agency (Ema)

Forecast breakeven date moved forward to 2024

New major risk - Share price stability

Forecast breakeven date moved forward to 2024

Inflarx N.V. Appoints Camilla Chong as Chief Medical Officer, Effective July 1, 2023

Forecast to breakeven in 2025

InflaRx N.V. Announces Details Related to the Design of its Planned Phase III Study with Vilobelimab in Ulcerative PG

InflaRx N.V. Provides Update on Planned Phase Iii Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of Its Eua Application in Critically Ill Covid-19 Patients

No longer forecast to breakeven

Forecast to breakeven in 2024

Forecast to breakeven in 2024

Independent Non-Executive Director Lina Ma has left the company

New 90-day high: €5.29

New 90-day high: €4.60

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