INF904 / InflaRx - LARVOL DELTA

InflaRx to Announce Topline Data from Phase 2a Clinical Trial of INF904 in Hidradenitis Suppurativa and Chronic Spontaneous Urticaria (GlobeNewswire) - "InflaRx expects to host a webcast/conference call accompanied by a slide presentation on Monday, November 10, 2025, at 8:00 AM EST / 2:00 PM CET to discuss the topline clinical data, and to also feature key opinion leader insight."

P2a data • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa

INF904 Phase 2a trial – Data expected to provide significant clarity on clinical utility in CSU and HS (GlobeNewswire) - "Given anticipated summer enrollment trends, we expect to report topline results from the ongoing Phase 2a basket study in HS and CSU by the end of September to early November...Enrollment in a third CSU dosing cohort (120 mg) targeting Type Iib phenotype patients very stringently selected as highly refractory to anti-IgE therapy is ongoing...Data from this last cohort in CSU will be announced in due course and, given sufficient demonstrated potential in the all-comer arms, is not expected to impact the timing of CSU Phase 2b trial initiation...Phase 2b trial go/no go decisions and study planning by year-end 2025."

New P2b trial • P2a data • Trial status • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa

InflaRx Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Interim analysis for vilobelimab Phase 3 trial in pyoderma gangrenosum (PG), to determine trial size adaptation or futility, remains on schedule with a recommendation expected to be announced at the end of May to early June; Topline data for INF904 Phase 2a trial in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected in summer 2025."

P2a data • P3 data • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa • Pyoderma Gangrenosum

InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones (GlobeNewswire) - "INF904 in CSU and HS : Topline data from this study are expected in the summer of 2025, with a goal of informing the planning and design of a larger, longer-term Phase 2b study by year-end 2025....Vilobelimab in PG : Pivotal Phase 3 trial interim analysis expected by the end of May 2025....GOHIBIC (vilobelimab): In January 2025, the European Commission (EC) granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced ARDS..."

EMA approval • P2b data • P3 data • Acute Respiratory Distress Syndrome • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa • Pyoderma Gangrenosum

InflaRx Announces Closing of $30 Million Public Offering of Ordinary Shares and Pre-Funded Warrants (GlobeNewswire) - "InflaRx...announced today that it has completed its underwritten public offering of 8,250,000 ordinary shares of the Company at a public offering price of $2.00 per ordinary share and in lieu of ordinary shares to certain investors, pre-funded warrants to purchase up to 6,750,000 of the Company’s ordinary shares....The aggregate gross proceeds from the offering were approximately $30 million, before deducting the underwriting discount and offering expenses....The Company intends to use the net proceeds from the offering primarily to fund clinical development of its pipeline candidates, including vilobelimab and INF904, and for general corporate purposes."

Commercial • Immunology • Inflammation

InflaRx Announces Pricing of $30 Million Public Offering of Ordinary Shares and Pre-Funded Warrants (GlobeNewswire) - "InflaRx N.V...announced today the pricing of its underwritten public offering of 8,250,000 ordinary shares of the Company at an offering price of $2.00 per ordinary share and in lieu of ordinary shares to certain investors, pre-funded warrants to purchase up to 6,750,000 of the Company’s ordinary shares. The purchase price of each pre-funded warrant is equal to the price per share at which ordinary shares are being sold to the public in this offering, minus $0.001, which is the exercise price of each pre-funded warrant...The offering is expected to close on February 18, 2025, subject to the satisfaction of customary closing conditions...The Company intends to use the net proceeds from the offering primarily to fund clinical development of its pipeline candidates, including vilobelimab and INF904, and for general corporate purposes."

Financing • Immunology • Inflammation

Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: InflaRx GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Hidradenitis Suppurativa • Immunology • Urticaria

InflaRx Announces First Patient Dosed in Phase 2a Study for Oral C5aR Inhibitor INF904 (GlobeNewswire) - "InflaRx...announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company’s oral C5aR inhibitor, INF904....The Phase 2a trial is a multi-center, open-label study expected to include a total of 75 patients with moderate-to-severe CSU and moderate-to-severe HS. The trial will evaluate multiple INF904 dosing regimens over 4 weeks of treatment to generate additional safety and pharmacokinetic (PK) data and to provide signs of clinical benefit....Data from this study are expected in the summer of 2025, with a goal of informing the design of a larger, longer-term Phase 2b study by year-end 2025."

New P2b trial • P2a data • Trial status • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa

Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: InflaRx GmbH

New P2 trial • Pan tumor • Chronic Spontaneous Urticaria • Dermatology • Hidradenitis Suppurativa • Immunology • Urticaria

InflaRx Hosts R&D Event Highlighting the Promise of INF904 (GlobeNewswire) - "Additional details provided on INF904 Phase 2a trial design in moderate-to-severe CSU and HS, with study initiation expected by the calendar year-end of 2024 and a goal of generating additional safety and pharmacokinetic (PK) data, and showing meaningful clinical benefit. INF904 Phase 2a data expected in summer 2025, with Phase 2b trial initiation expected in 2025. InflaRx’s strong financial position is expected to fund company operations into 2026, allowing for advancement of clinical programs towards next milestones."

Financing • New P2a trial • New P2b trial • P2a data • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa

InflaRx Reports First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "InflaRx announced it had chosen two initial immuno-dermatology indications it intends to pursue with INF904 and that it plans to initiate a Phase IIa 'basket study'. This open-label, 4-week, multi-dose trial enrolling CSU and HS patients is expected to begin by the end of 2024 and to assess safety, as well as PK and PD parameters. InflaRx anticipates releasing data from this Phase IIa study in 2025. Similarly, the company expects to initiate a Phase IIb study in 2025 as well."

New P2a trial • New P2b trial • P2a data • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa

InflaRx Announces Positive Topline Results from the Single Ascending Dose (SAD) Phase I Study with C5aR Inhibitor INF904 (GlobeNewswire) - P1 | N=62 | "InflaRx N.V....announced today its topline results from the single ascending dose (SAD) part of its randomized, double-blind, placebo-controlled Phase I trial of the orally administered, low molecular weight C5aR inhibitor INF904. In the SAD part of the study, INF904 demonstrated an excellent safety and tolerability profile as well as a very favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile, confirming INF904´s best-in-class potential....Single doses of 30 mg or higher of INF904 achieved ≥90% blocking of C5a induced up-regulation of the activation marker CD11b on neutrophils in plasma samples from subjects ex vivo at 24 hours post dosing. This inhibition was achieved when 12.6 nM recombinant C5a was added as stimulus in this assay, a C5a concentration which can be observed in patients with severe inflammatory conditions such as the immuno-dermatological disease, hidradenitis suppurativa..."

P1 data • Hidradenitis Suppurativa • Immunology

InflaRx Reports Second Quarter 2023 Financial Results & Operating Update (GlobeNewswire) - "InflaRx N.V...announced today financial results for the three and six months ended June 30, 2023 and provided an operating update...InflaRx presented details related to the design of its planned pivotal Phase III study with vilobelimab...InflaRx submitted a Phase III clinical trial protocol to the FDA, initiated the preparatory activities and expects the first patient to be enrolled in Q3 2023...The Company plans to show the effect of INF904 on C5a-induced downstream activity and to generate data in a format comparable with other published data on C5aR inhibitory molecules like avacopan....Results from the SAD part of the study are expected for Q3 2023 and results from the MAD part of the study are expected in Q4 2023."

P1 data • Trial status • Dermatology • Immunology • Inflammation • Pyoderma Gangrenosum