InflaRx N.V. develops anti-inflammatory therapeutics that target the complement system through proprietary anti-C5a and anti-C5aR technologies. Its lead program, izicopan, is an orally administered small-molecule inhibitor of C5a-induced signaling via the C5a receptor, and vilobelimab is an intravenously delivered anti-C5a monoclonal antibody that selectively binds free C5a.
Company news commonly covers izicopan clinical-development strategy, preclinical pharmacology data, complement-mediated inflammatory disease programs, financial results, ordinary-share financings, Nasdaq listing compliance, annual meeting matters and investor communications. Updates also address the company’s operating group, which includes wholly owned subsidiaries in Germany and the United States.
InflaRx N.V. (Nasdaq: IFRX) announced the appointment of Tony Gibney as a Non-Executive Director to its Board, approved by shareholders at the 2021 annual meeting. Gibney, a seasoned biotech executive and former investment banker, brings extensive experience in financing and M&A transactions. He aims to support InflaRx's strategy in complement C5a inhibition, a critical area for autoimmune diseases. Mark Kübler and Lina Ma were re-elected as board members, who have significantly contributed to the company since its IPO in 2017.
InflaRx reported progress in several clinical trials, including reaching 178 patients in its severe COVID-19 trial, with an interim analysis expected in Q3 2021. The company is preparing to discuss the primary endpoint for its Phase III trial of vilobelimab in Hidradenitis Suppurativa with the FDA. Financially, as of March 31, 2021, InflaRx held approximately €137.8 million in cash and equivalents. In Q1 2021, net loss decreased to €6.1 million from €8.2 million year-over-year. Overall, the company is focused on advancing its clinical programs and has observed a decline in R&D expenses.
InflaRx has announced positive topline results from its U.S. Phase II IXPLORE trial for vilobelimab, demonstrating safety and tolerability in patients with ANCA-associated vasculitis (AAV). The study, involving 19 patients, showed no safety concerns and highlighted favorable clinical responses. Vilobelimab was well received alongside standard care, with 85.7% of patients on 400 mg and 75% on 800 mg achieving remission by week 16. The ongoing EU IXCHANGE trial is fully enrolled, with results anticipated by the end of 2021, potentially paving the way for further development of vilobelimab in AAV.
InflaRx N.V. (Nasdaq: IFRX) announced that it has successfully enrolled 18 patients in its Phase IIa study of vilobelimab for treating Pyoderma Gangraenosum (PG). This open-label study is designed to evaluate the safety and efficacy of vilobelimab, with interim results expected by the end of 2021 and final results anticipated in 2022. Initial data from five patients showcased promising healing results. PG is a debilitating autoimmune disease with no FDA-approved treatments, highlighting the potential significance of vilobelimab in patient care.
InflaRx (Nasdaq: IFRX) reported its financial results for 2020, highlighting a net loss of €34 million, an improvement from €53 million in 2019. The company has approximately €81.4 million in cash and financial assets and completed a $75 million public offering to strengthen its financial position. Key developments include the submission of a Special Protocol Assessment to the FDA for vilobelimab in Hidradenitis Suppurativa and ongoing Phase III trials for severe COVID-19 and ANCA-associated vasculitis. Topline data from these trials are expected in 2021.
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company, announced management will present at two virtual investor conferences in March 2021. The H.C. Wainwright Global Life Sciences Conference will feature an on-demand presentation by CEO Prof. Niels C. Riedemann on March 9, 2021, starting at 7:00 am EST. Meanwhile, the Oppenheimer 31st Annual Healthcare Conference will host a live presentation on March 16, 2021, at 8:00 am EST. InflaRx focuses on developing innovative anti-inflammatory therapies targeting the complement system.
InflaRx N.V. (Nasdaq: IFRX) announced the completion of an underwritten public offering of 15 million common shares at $5.00 each, raising approximately $75 million in gross proceeds. Each share came with a warrant for an additional share at $5.80. The company plans to utilize the net proceeds primarily for research and development expenses and general corporate needs. The offering was managed by Guggenheim Securities and Raymond James & Associates. InflaRx specializes in developing anti-inflammatory therapeutics targeting the complement system.
InflaRx N.V. (Nasdaq: IFRX) has announced the pricing of its underwritten public offering of 15,000,000 common shares at $5.00 each, along with warrants priced at $5.80. The gross proceeds are expected to total approximately $75 million, earmarked primarily for research and development, and general corporate purposes. The warrants are immediately exercisable for one year. Guggenheim Securities and Raymond James are joint managers for the offering. The registration statement effective since July 2020 supports this initiative.
InflaRx N.V. (Nasdaq: IFRX) has announced an underwritten public offering of common shares, paired with warrants for additional shares. The company aims to utilize the net proceeds for research and development expenses and general corporate purposes. The offering's completion will depend on market conditions. Guggenheim Securities and Raymond James are the joint book-running managers for this offering. A registration statement with the SEC was previously filed and is effective since July 17, 2020. This announcement is not an offer to sell or buy securities.
InflaRx (Nasdaq: IFRX) announced new findings on vilobelimab at the EHSF Conference, highlighting significant increases in baseline C5a levels in patients with moderate to severe hidradenitis suppurativa (HS). Data show that vilobelimab dose-dependently reduces these C5a levels, correlating with decreased inflammatory lesions. The results support the further development of vilobelimab in treating HS, with promising data presented by Prof. Giamarellos-Bourboulis. This highlights the potential of targeting C5a in managing HS symptoms.