Welcome to our dedicated page for InflaRx N.V. news (Ticker: IFRX), a resource for investors and traders seeking the latest updates and insights on InflaRx N.V. stock.
InflaRx N.V. (NASDAQ: IFRX) is a clinical-stage biopharmaceutical company dedicated to discovering and developing inhibitors using C5a technology, primarily in Germany and the United States. The company focuses on targeting the complement activation factor known as C5a, an inflammatory mediator linked to various autoimmune and inflammatory diseases.
InflaRx's lead product candidate is vilobelimab (formerly known as IFX-1), a first-in-class, intravenously delivered anti-C5a monoclonal antibody. Vilobelimab has completed Phase IIb clinical trials for treating hidradenitis suppurativa, a rare and chronic inflammatory skin disease, as well as for ANCA-associated vasculitis, a life-threatening autoimmune condition, and pyoderma gangrenosum, a chronic inflammatory skin disorder. Additionally, the company is exploring vilobelimab’s potential in treating oncological diseases.
InflaRx is also developing IFX-2, another anti-inflammatory and autoimmune disease treatment currently in pre-clinical development. The company’s proprietary C5a/C5aR technology enables the creation of potent and specific inhibitors, positioning InflaRx as a pioneer in this niche therapeutic area.
The company has established a co-development agreement with Beijing Defe, enhancing its research and development capacity. InflaRx's innovative therapies aim to significantly improve patient outcomes in diseases with substantial unmet medical needs.
InflaRx announced significant progress in its clinical trials and a financial update for Q2 2021. The severe COVID-19 trial has enrolled 299 patients, with an independent data monitoring committee recommending continuation. A Type A meeting has been requested with the FDA regarding the Phase III study for Hidradenitis Suppurativa. The first patients have been dosed in a Phase II trial for Cutaneous Squamous Cell Carcinoma. As of June 30, 2021, financial assets total approximately €127.5 million, though the company reported a net loss of €20.9 million for the first half of 2021.
InflaRx N.V. (Nasdaq: IFRX) will virtually present at the Raymond James Human Health Innovation Conference from June 21-23, 2021. Prof. Niels C. Riedemann, CEO and Founder, will engage in a fireside chat on June 23 at 10:00 am EDT, discussing the company's pipeline and forthcoming catalysts. A live webcast will be available on InflaRx's website, with a replay accessible post-event. The company specializes in developing anti-inflammatory therapeutics targeting the complement system, specifically using its proprietary anti-C5a technology.
InflaRx N.V. (Nasdaq: IFRX) has initiated a Phase II clinical trial evaluating vilobelimab, both as a standalone treatment and in combination with pembrolizumab, for patients with PD-1 or PD-L1 inhibitor-resistant locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). The trial aims to enroll around 70 patients and assess the safety and anti-tumor efficacy of vilobelimab. Given the poor prognosis of advanced cSCC, the development of vilobelimab, a monoclonal antibody targeting C5a, could provide vital treatment options for patients.
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.
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