Inflarx - IFRX STOCK NEWS

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.

InflaRx has amended its existing co-development agreement with Staidson (Beijing) BioPharmaceuticals Co., Ltd. (STS) to support regulatory approval for BDB-001, an anti-C5a antibody for COVID-19, in China. InflaRx will receive 10% royalties on net sales from BDB-001, and STS plans to invest USD 2.5 million in InflaRx at USD 5.00 per share. There's an option for a further USD 7.5 million investment contingent on STS obtaining regulatory approval. This partnership enhances InflaRx's financial position amid rising COVID-19 cases in China.

InflaRx N.V. (Nasdaq: IFRX) has initiated a randomized, double-blind, placebo-controlled Phase I trial for its orally administered C5aR inhibitor, INF904. The study aims to evaluate the drug's safety, tolerability, and pharmacokinetics in approximately 62 healthy volunteers. Previously, preclinical studies indicated INF904's potential to inhibit C5a signaling without significant toxicity. This trial marks a significant step in addressing complement-mediated chronic diseases.

InflaRx N.V. (Nasdaq: IFRX) recently earned both Orphan Drug and Fast Track designations for vilobelimab as a treatment for critically ill COVID-19 patients, alongside an Emergency Use Authorization (EUA) submission to the FDA. Positive results from the PANAMO Phase III study were published in The Lancet Respiratory Medicine. The company reported €93.2 million in cash and securities, projected to fund operations until year-end 2024. Financial results showed reduced net loss of €21.5 million for the nine months ending September 30, 2022, an improvement from €33 million in the same period last year.

InflaRx (Nasdaq: IFRX) has submitted a request for Emergency Use Authorization (EUA) for vilobelimab, aimed at treating critically ill COVID-19 patients. The EUA request is based on the results of the PANAMO Phase III trial, published in The Lancet Respiratory Medicine. The FDA has also granted Fast Track designation for vilobelimab, which allows for expedited development and review. The proprietary name ‘Gohibic’ has been conditionally accepted by the FDA, marking significant progress in making this therapy available to patients.