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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 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.
InflaRx (Nasdaq: IFRX) announced significant developments regarding its anti-C5a antibody, vilobelimab (IFX-1). A Phase II trial for cutaneous squamous cell carcinoma is set to start in H1 2021. The company also plans to submit a Special Protocol Assessment for a Phase III trial in Hidradenitis Suppurativa this quarter. Additionally, inclusion in a global Phase II/III trial for severe COVID-19 is ongoing, with 360 patients expected to enroll. Topline results for various studies, including ANCA-associated vasculitis, are anticipated in 2021.
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company, is set to present virtually at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 7:30 am EST. CEO Prof. Niels C. Riedemann will deliver a corporate presentation. A live audio webcast will be available on the InflaRx website, with replays archived for 30 days. Additionally, a presentation from the H.C. Wainwright Virtual BioConnect Conference will be accessible starting January 11, 2021, at 6:00 am EST.
InflaRx specializes in developing anti-inflammatory therapeutics targeting the complement system.
InflaRx (Nasdaq: IFRX) announced the completion of patient enrollment for its European phase II IXCHANGE study of vilobelimab (IFX-1) in ANCA-associated vasculitis (AAV). The study enrolled 57 patients across Europe to assess vilobelimab's safety and efficacy in treating AAV, a rare autoimmune disease affecting approximately 40,000-75,000 patients in the US and Europe. The trial consists of two parts, with final results expected by the end of 2021. Vilobelimab is a first-in-class anti-C5a antibody, promising for AAV treatment and currently undergoing multiple clinical trials.
InflaRx (Nasdaq: IFRX) announced the initiation of a Phase III trial for IFX-1 in severe COVID-19 pneumonia, backed by positive Phase II data published in The Lancet Rheumatology. As of September 30, 2020, the company reported cash reserves of approximately €95.7 million, and a net loss of €25.1 million for the nine months ended, improving from €39.6 million the previous year. Leadership changes included the appointment of a new CFO and the promotion of a Chief Strategy Officer. The company also continues development for IFX-1 in other inflammatory conditions, emphasizing ongoing clinical trials.
InflaRx (Nasdaq: IFRX) announced key management appointments: Thomas Taapken, Ph.D., joins as Chief Financial Officer starting October 1, 2020, and Jordan Zwick is promoted to Chief Strategy Officer. Prof. Niels C. Riedemann emphasized Taapken's extensive biopharmaceutical experience, which will aid the company's late-stage clinical programs, while Zwick's new role aims to enhance U.S. operations. Taapken expressed enthusiasm about leading InflaRx during its first Phase III trial for anti-C5a therapeutics, crucial for addressing chronic inflammatory diseases, including COVID-19 pneumonia.
InflaRx (Nasdaq: IFRX) has initiated the global Phase III trial of IFX-1 for severe COVID-19 pneumonia, with the first site now active in the Netherlands and approval in Germany. The trial aims to enroll approximately 360 critically ill patients and will assess 28-day all-cause mortality as the primary endpoint. Encouraging Phase II results, showing lower mortality and organ dysfunction rates, have been accepted for publication in The Lancet Rheumatology. IFX-1, targeting complement factor C5a, is also being explored for other indications.
InflaRx announced positive results from the Phase II portion of its Phase II/III trial for IFX-1 in COVID-19 pneumonia, showing a 28-day all-cause mortality rate of 13% for treated patients versus 27% in controls. They completed a meeting with the FDA regarding IFX-1 for hidradenitis suppurativa, receiving support for a Phase III program. The company reported cash and equivalents of €98.9 million as of June 30, 2020, and a net loss of €18.3 million, an improvement from €25.1 million in the same period of 2019. Financial metrics indicate reduced research and development expenses.
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