IFRX News & Events

InflaRx announced that data from the Phase 3 study of vilobelimab in pyoderma gangrenosum were featured in an oral presentation during the late-breaking research abstract session at the 2026 American Academy of Dermatology annual meeting being held March 27-31, 2026, in Denver. The data presented included signals of clinical activity across multiple measures, with higher rates of complete remission, target ulcer closure, and reductions in ulcer volume, as well as a positive safety profile. The primary endpoint, complete target ulcer closure, was achieved by 20.8% of vilobelimab patients versus 16.7% on placebo. Complete disease remission occurred more frequently with vilobelimab than placebo. In addition, over one-third of vilobelimab-treated patients achieved more than a 50% reduction in ulcer volume compared with 16.7% of patients receiving placebo. Physician Global Assessment scores and Dermatology Life Quality Index also showed trends favoring vilobelimab. Vilobelimab treatment also was shown to substantially reduce C5a levels, with mean change from baseline of 76.6% compared to 13.5% with placebo. The treatment was generally well tolerated, with most adverse events reported as mild to moderate and similar rates of serious adverse events between groups.

Reports revenue EUR 29.3M vs. EUR 165.8M last year. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: "With the strong Phase 2a results reported in hidradenitis suppurativa and chronic spontaneous urticaria, and its best-in-class potential, we made the strategic decision to focus our resources on izicopan. We are in active discussions with the FDA for the design of our Phase 2b trial in HS and look forward to establishing a clear path forward soon. By tightly focusing the Company on izicopan in select inflammation and immunology indications, we believe we are well positioned to advance to the next stage of development and effectively execute our plans."

InflaRx 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. As part of its strategic focusing, InflaRx is streamlining its organizational structure and largely discontinuing non-essential activities outside the development of izicopan. These actions are designed to sharpen the Company's strategic execution, concentrate resources on its highest-value asset, and materially improve capital efficiency. InflaRx has initiated a workforce reduction of approximately 30% and substantial spending reductions, including significant reductions in Gohibic commercial spending and related functions. The Company estimates these activities will result in a one-time charge of approximately $7M. The majority of this charge will be a non-cash charge related to the write-off of vilobelimab inventory, with a smaller portion associated with the restructuring, including personnel-related costs and the termination or modification of certain third-party contracts. Upon completion, InflaRx expects a significantly leaner cost structure, enabling substantial and sustained reductions in operating expenses and a meaningful extension of its cash runway to mid-2027. InflaRx will maintain the operational capability needed to support the ongoing BARDA "Just Breathe" Phase 2 clinical platform study in ARDS and does not expect these actions to negatively impact the trial. InflaRx will keep Gohibic available for ordering inside the US under its emergency use authorization and maintain the ability to satisfy Gohibic demand in the US on a reactive basis. InflaRx will continue to review partnering opportunities for Gohibic in the US and Europe. In addition, as previously disclosed, the Company anticipates meeting with the FDA to determine a potential development path forward for vilobelimab in pyoderma gangrenosum, which it anticipates would only be conducted in collaboration with a partner. Given data demonstrating its advantageous PK/PD profile, meaningful differentiation as an inhibitor of the C5a/C5aR axis, and potential to address HS, chronic spontaneous urticaria and other I&I indications, the Company will prioritize resource allocation and clinical development toward izicopan while continuing active dialog with potential partners across all geographies to expedite and maximize value. In HS InflaRx continues to make progress toward Phase 2b readiness. InflaRx is in active dialogue with the FDA related to the Phase 2b study design and potential endpoints. The aim is to align on a development path and endpoints expected to meaningfully differentiate izicopan from existing therapies, while also addressing variability inherent in some HS trial outcomes. InflaRx is moving as quickly as is feasible in this effort and intends to provide an update on its HS Phase 2b planning and readiness in due course. InflaRx sees significant potential for izicopan to address unmet needs in multiple I&I indications beyond HS, including CSU, where InflaRx continues data analysis and active dialog with thought leaders to determine next steps. Given the supportive nature of the Phase 2a data collected to-date from the two main CSU dosing cohorts, and low enrollment trends in the third dosing cohort, InflaRx has decided to close the third treatment cohort. InflaRx will utilize the existing data set to determine next steps for izicopan in CSU, which the Company expects to communicate later this year. InflaRx intends to submit the izicopan Phase 2a datasets in HS and CSU for presentation at medical conferences later this year.