InflaRx N.V.

We are excited that JAMA Dermatology has published a case report titled, “Treatment of Pyoderma Gangrenosum With Vilobelimab” from our completed Phase 2 trial in pyoderma gangrenosum (PG). PG is a rare neutrophilic dermatosis that often results in significant morbidity due to rapidly progressing cutaneous ulcerations. There are no FDA-approved medications for PG and patients are often treated with different immunomodulators including corticosteroids and biologics. Vilobelimab’s mode of action is highly relevant to PG, as it targets C5a, a strong activator of neutrophils. The case report discusses the treatment of a patient suffering from this debilitating inflammatory condition with #vilobelimab, InflaRx’s anti-complement factor #C5a monoclonal antibody. A PG ulcer that had been present for 6 months prior to inclusion in the study showed complete closure by Day 71 during vilobelimab treatment and did not relapse during the observation time after discontinuation of vilobelimab. Concurrent treatment with other immunomodulation was well tolerated by this patient. This further underscores vilobelimab’s potential for treating neutrophil-driven disorders such as PG and other conditions. You can find the full article in JAMA here: https://lnkd.in/dvfgnXvY InflaRx is currently conducting a Phase 3 trial investigating the efficacy and safety of vilobelimab in patients with ulcerative PG, with an interim analysis expected in 2025.

We are excited to announce that #GOHIBIC (vilobelimab) has been selected by Biomedical Advanced Research and Development Authority (BARDA) as an investigational therapy to be assessed in a Phase 2 clinical platform study that explores potential new options for the treatment of #ARDS. The Phase 2 multicenter, randomized, double-blind, placebo-controlled trial, will evaluate the safety and efficacy of three selected novel host-directed therapeutics, including GOHIBIC, at approximately 60 U.S. sites, with a total target enrollment of 600 hospitalized adults with ARDS. Given vilobelimab’s potent inhibition of #C5a and a host-directed mechanism of action, we believe it has the potential for broader applicability as a potent anti-inflammatory agent in ARDS. Read the full press release here: https://lnkd.in/dSihN_yt

Today, we hosted an R&D event to highlight the promise of our oral small molecule INF904 as a potential treatment for chronic spontaneous urticaria (CSU), hidradenitis suppurativa (HS), and its broader therapeutic potential.   Prof. Dr. Marcus Maurer, Prof. Dr. Jörg Köhl and Christopher Sayed, MD, thought leaders in complement inhibition, CSU and HS, provided compelling new insights into the strong development rationales, potential differentiation and medical role of INF904 in initially targeted indications and inflammation & immunology (I&I) more broadly. InflaRx also presented additional details on INF904 Phase 2a trial design in moderate-to-severe CSU and HS, with study initiation expected by the calendar year-end of 2024. Supplemental information related to today’s event, including presentations conducted by the KOLs and InflaRx management can be found in the accompanying slide deck: https://lnkd.in/eHz-MqMN.   Read the full press release here: https://lnkd.in/dvkaE4Kt

Day 1 was already great, looking forward to next three days!

At the American Thoracic Society International Conference 2024, InflaRx is presenting a post-hoc subgroup analysis of PANAMO, our Phase III trial in severe COVID-19. The new data shows a potential synergy of the combination of #vilobelimab with other immunomodulators and is being presented during the “#ARDS and Acute Respiratory Failure: Mechanism, Risk, and Outcomes” poster session.   The analysis presented at #ATS 2024 is comprised of a subgroup of 71 patients who received the immunomodulators tocilizumab or baricitinib as part of the standard-of-care treatment, in combination with either vilobelimab or placebo. The point estimate for 28-day all-cause mortality was 6.3% in the vilobelimab plus tocilizumab or baricitinib arm, and 40.9% in the placebo plus tocilizumab or baricitinib arm: this is a significant relative reduction of 84.6% (HR 0.13; 95% CI:0.03-0.56, p=0.006) between the two arms.   To find out more, read our PR: https://lnkd.in/dN55kGXa

Today, we announced our Q1 financial results and the significant progress we have made during the first months of this year. We have strategically prioritized our efforts, focusing development activities on vilobelimab in pyoderma gangrenosum and #INF904 in chronic spontaneous urticaria and hidradenitis suppurativa. Sharpening our profile in this way has helped put us in a strong financial position, allowing us to advance our clinical programs towards their next milestones and to fund operations at least into 2026. Read more in our press release: https://lnkd.in/dNBxv3Jg

Today we announced two upcoming events. On May 8th, we will publish our Q1 financial results. We are pleased to also announce that InflaRx will host a virtual R&D event on June 5th. The R&D event will focus on the planned development of our new oral small molecule C5aR inhibitor, #INF904, and the role of #C5aR in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). InflaRx speakers will be joined by internationally renowned thought leaders to discuss underlying development rationales and expected Phase IIa trial design for INF904 and to provide insights into the commercial opportunity. In addition, we will discuss INF904's broader therapeutic potential in the immuno-inflammation field and recent advances in our understanding of the role of C5a/C5aR signaling as it relates to human inflammatory diseases. Register here for the event: https://lnkd.in/dPbGbYvh Read the full PR here: https://lnkd.in/dnf-swNR

We are happy to announce our participation in the Capital One Securities 1st Annual Biotech/Biopharma Disrupters Event.   We will join the panel, New Potential Dermatology Treatments for Psoriasis, Urticaria, and Alopecia, scheduled on May 14, 2024, at 2:30 PM EDT / 8:30 PM CEST as part of the in-person event in New York City.   For more information on InflaRx and our pipeline, please visit: https://www.inflarx.de/

We are excited to provide a comprehensive strategic update on our future development and operational plans, along with our financial and operating results for the year ended December 31, 2023. With our immuno-dermatology focus, we will center development activities and resources initially on selected indications with our registrational-phase monoclonal antibody vilobelimab and our potentially best-in-class oral C5aR inhibitor INF904. For INF904, we have chosen two initial indications that we intend to pursue in a Phase IIa “basket study” starting before the end of 2024. These indications are chronic spontaneous urticaria (CSU) and hidradenitis suppurative (HS), two chronic inflammatory skin conditions in which C5a has been suggested to play a significant role, and where a high unmet need exists. We also are considering partnership options in additional areas of interest with the goal of unlocking INF904’s “pipeline-in-a-product" potential more broadly. Our strategy and planning for our C5a antibody vilobelimab in pyoderma gangrenosum (PG) remain unchanged and its development is on track. Our ongoing Phase III trial with vilobelimab in PG is expected to have an interim analysis in 2025. We are providing a pipeline update including details on the chosen indications for INF904 today, March 21, 2024, at 8:00 am ET. Tune in live or to the replay to learn more: https://lnkd.in/gSsDh_fa

We are delighted to welcome Jan Medina, CFA, as Vice President and Head of Investor Relations of InflaRx. Mr. Medina brings over 25 years of extensive experience across the life sciences sector and capital markets, including in the areas of investor relations, communications and equity research. His experience, proven track record and deep network with investors and capital markets will be invaluable as we continue to advance our clinical programs and strengthen our relationships with the investor community. Read the full press release here: https://lnkd.in/dEXKTatV