IFRX News & Events

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.

InflaRx outlined multiple data analyses of the Phase 3 study for vilobelimab in pyoderma gangrenosum, which was terminated earlier this year after an Independent Data Monitoring Committee recommended the trial be stopped early due to futility. The analyses disclosed today include the primary intent-to-treat analysis and several post-hoc analyses on the 54 patients enrolled in the trial at the time of study termination. The Phase 3 study had recruited a total of 54 patients at the time the interim analysis was conducted, including 30 patients who had completed 6 months of treatment. The primary clinical endpoint of complete target ulcer closure on two consecutive visits showed a difference in favor of vilobelimab over placebo of 20.8% versus 16.7%. Key secondary endpoints such as complete disease remission showed improvement in favor of vilobelimab over placebo and those with greater than50% reduction of target ulcer volume at week 26. In addition, patients reported feeling better as measured by the Dermatology Life Quality Index mean percentage change at the end of treatment visit. Overall, vilobelimab was well tolerated. Observed treatment-emergent adverse events were mostly mild to moderate, and patients with serious related on-treatment TEAEs were similarly distributed. In addition, further post-hoc analyses showed that there is an overall treatment effect with vilobelimab when compared to placebo. These include an MMRM for percent change in target ulcer volume, which showed an average effect over all visits in favor of vilobelimab over placebo when imputing patients with treatment-related discontinuation reasons, including patient level stopping criteria with a last observation carried forward approach. This analysis yielded a significant treatment difference for every week from Week 14 to Week 26 for vilobelimab over placebo. In addition, ANCOVAs for mean of percentage changes from baseline in volume and area from Week 12 until Week 26 were also in favor of vilobelimab, including mean of percentage change from baseline in volume and area. These analyses suggest that treatment longer than 26 weeks with vilobelimab may provide improved treatment outcomes in this difficult-to-treat ulcerative PG population. As next steps, InflaRx anticipates meeting with the FDA to discuss a potential path forward for vilobelimab in PG, including the use of alternative endpoints that could be utilized for potential future clinical studies. At this time, in an effort to prioritize izicopan development, InflaRx does not expect to deploy significant resources towards future vilobelimab development in PG on its own and will instead consider doing so in collaboration with a partner.

InflaRx announced that the World Health Organization has granted the international nonproprietary, or generic, name of "izicopan" to the company for its orally available C5aR inhibitor, formerly known as INF904, in accordance with the WHO's Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances. In the next step of this process, the name "izicopan" will be published in the recommended list of INNs.