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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) announced the completion of its public offering of 9,411,765 ordinary shares, raising approximately $46 million after the underwriters exercised their option to purchase an additional 1,411,764 shares at a price of $4.25 each. The proceeds will fund the development of vilobelimab, research and development expenses, and investments in commercial infrastructure. Raymond James & Associates served as the sole book-running manager for this offering, and a shelf registration statement was declared effective by the SEC on July 17, 2020. The offering's details, including the prospectus, are available through the SEC's website or directly via Raymond James.
InflaRx N.V. (Nasdaq: IFRX) has completed an underwritten public offering of 9,411,765 ordinary shares at a price of $4.25 per share, raising approximately $40 million in gross proceeds. The underwriters were granted a 30-day option to purchase an additional 1,411,764 shares. The funds will be allocated towards the ongoing development of vilobelimab, general research and development, and strengthening the company’s commercial infrastructure. The offering was facilitated through a shelf registration statement effective since July 17, 2020, with all necessary filing made with the SEC. InflaRx is focused on developing innovative therapies targeting the complement system, particularly in addressing autoimmune and inflammatory diseases.
InflaRx N.V. (Nasdaq: IFRX) announced a public offering of 9,411,765 ordinary shares at a price of $4.25 per share, expected to close on April 14, 2023. An additional 1,411,764 shares are available for purchase by underwriters. The net proceeds will support the development of vilobelimab, general R&D expenses, and corporate needs. The offering is made under a shelf registration statement declared effective by the SEC on July 17, 2020. Raymond James & Associates is the sole book-running manager, with LifeSci Capital as co-manager. This press release serves as a notice and does not constitute an offer or solicitation to sell securities.
InflaRx N.V. (Nasdaq: IFRX) has announced an underwritten public offering of ordinary shares, subject to market conditions. The company expects to grant underwriters a 30-day option for additional shares at the offering price. The proceeds will fund the continued development of vilobelimab, support research and development expenses, and reinforce the company’s commercial infrastructure. Raymond James & Associates is the sole book-running manager, with LifeSci Capital serving as a co-manager. This offering is facilitated under a shelf registration effective since July 17, 2020, with details available in a prospectus filed with the SEC. The company emphasizes that this press release does not constitute an offer to sell or solicitation to buy securities.
InflaRx (Nasdaq: IFRX) announced that the FDA has granted Emergency Use Authorization (EUA) for its drug Gohibic (vilobelimab), a monoclonal antibody targeting complement factor C5a, to treat critically ill COVID-19 patients. This decision follows promising results from a Phase III trial, showing a 23.9% reduction in 28-day all-cause mortality compared to placebo. The company is pursuing a Biologics License Application (BLA) for full approval and is also engaging with the European Medicines Agency (EMA) for similar authorization. A conference call is scheduled for April 5, 2023, to discuss these developments.
InflaRx N.V. (Nasdaq: IFRX) has made significant strides in its development of vilobelimab, particularly for pyoderma gangrenosum (PG), receiving FDA recommendations and Fast Track and Orphan Drug designations. A Phase III trial protocol has been submitted, with patient enrollment expected mid-2023. The company also submitted an Emergency Use Authorization (EUA) application for vilobelimab to treat critically ill COVID-19 patients, following promising Phase III results published in The Lancet. Additionally, the company initiated a Phase I trial for its oral C5aR inhibitor, INF904. Financially, InflaRx reported €83.7 million in available funds as of Dec 31, 2022, supporting operations through H2 2025.
InflaRx N.V. (Nasdaq: IFRX) announced a Phase III trial design for vilobelimab targeting ulcerative pyoderma gangrenosum (PG). The adaptive trial will enroll approximately 50-100 patients across multiple regions, including the US and Europe. An interim analysis will take place after 30 patients to potentially adjust the trial size. The FDA is currently reviewing an EUA application for vilobelimab in critically ill COVID-19 patients. Additionally, the management team will engage with investors during JPM Week from January 9-12, 2023.