Inflarx Stock Price, News & Analysis

InflaRx N.V. (IFRX) has announced the commencement of an underwritten public offering of ordinary shares and pre-funded warrants. The pre-funded warrants will be priced at the public offering price minus $0.001, which will be their exercise price. Guggenheim Securities, is serving as the book-running manager for the offering.

The company plans to grant underwriters a 30-day option to purchase additional ordinary shares at the public offering price, less underwriting discount. The net proceeds will be used to fund clinical development of pipeline candidates, including vilobelimab and INF904, and for general corporate purposes.

The offering is being made under a shelf registration statement declared effective by the SEC on July 11, 2023. The final terms will be disclosed in a final prospectus supplement to be filed with the SEC.

InflaRx N.V. (IFRX) has announced its participation in the upcoming Guggenheim SMID Cap Biotech Conference, scheduled for February 5-6, 2025, in New York. The company specializes in developing anti-inflammatory therapeutics targeting the complement system.

InflaRx's primary focus is on their proprietary anti-C5a and anti-C5aR technologies, which are used to develop inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenous first-in-class anti-C5a monoclonal antibody that has shown promising clinical activity across multiple indications. The company is also developing INF904, an oral small molecule C5a receptor inhibitor.

InflaRx (NASDAQ: IFRX) has received European Commission marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab), the first approved treatment in the European Union for SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). The approval applies to adult patients receiving systemic corticosteroids and invasive mechanical ventilation, with or without ECMO.

The authorization is supported by Phase 3 PANAMO trial results, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. The approval covers all 27 EU member states plus Iceland, Liechtenstein, and Norway. InflaRx is exploring commercial partnering options in the EU.

In the US, GOHIBIC has received Emergency Use Authorization from the FDA for COVID-19 treatment in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO.

InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focused on anti-inflammatory therapeutics, has announced its participation in multiple events during the week of January 13, 2025, in San Francisco. The company will attend the LifeSci Partners Corporate Access Event for one-on-one meetings on January 14-15, and participate in a workshop at Biotech Showcase 2025 on January 15 titled 'The Need for Novel Responses to Disease Threat(s) in a Fast-Changing World.'

InflaRx specializes in developing inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenous anti-C5a monoclonal antibody. The company is also developing INF904, an oral C5a receptor inhibitor. Founded in 2007, InflaRx maintains offices in Jena and Munich, Germany, and Ann Arbor, MI, USA.

InflaRx has initiated dosing in its Phase 2a basket study for INF904, an oral C5aR inhibitor, targeting chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The study will enroll 75 patients, with 45 CSU patients receiving doses of 60mg or 120mg BID, and 30 HS patients randomized across 60mg, 90mg, or 120mg BID doses over 4 weeks. The trial aims to evaluate safety, pharmacokinetics, and clinical benefits, with data expected in summer 2025. Each indication represents potential addressable markets of $1 billion or more. The company plans to use study results to design a larger Phase 2b trial by year-end 2025.

InflaRx received a positive CHMP opinion recommending marketing authorization for GOHIBIC® (vilobelimab) under exceptional circumstances for treating SARS-CoV-2-induced ARDS in adult patients. The treatment is specifically for patients receiving systemic corticosteroids and invasive mechanical ventilation. The European Commission is expected to issue marketing authorization within 67 days.

The recommendation is supported by Phase 3 PANAMO trial results, showing vilobelimab improved survival with a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. InflaRx plans to commercialize GOHIBIC® in Europe and is considering commercial distribution options with potential partners, noting this approach won't significantly impact cash burn rate.

InflaRx reported Q3 2024 financial results and business updates. Key developments include reaching a 30-patient recruitment milestone in Phase 3 vilobelimab trial for pyoderma gangrenosum, with interim analysis expected by end of Q2 2025. The company plans to initiate a Phase 2a trial for INF904 by year-end 2024, with first data readout expected in summer 2025. Cash position stands at €62.0 million, expected to fund operations into 2026. Revenue from GOHIBIC sales was €166 thousand, with net loss increasing to €41.0 million for the first nine months of 2024 compared to €26.7 million in the same period of 2023.

InflaRx (Nasdaq: IFRX), a biopharmaceutical company focused on anti-inflammatory therapeutics, announced it will release its Q3 2024 financial results on November 8, 2024, before market open. The company will also participate in the Guggenheim Securities Inaugural Healthcare Innovation Conference from November 11-13, 2024, in Boston, featuring a fireside chat on November 11th at 11:00 am ET. InflaRx specializes in developing inhibitors of complement activation factor C5a and its receptor C5aR, with their lead candidate vilobelimab and oral small molecule inhibitor INF904.

InflaRx presented a post hoc analysis of the SHINE Phase 2b study of vilobelimab in hidradenitis suppurativa (HS) at the 2024 EADV Congress. The analysis focused on the 1200 mg dose, which showed significant improvements compared to placebo at 16 weeks:

- 45.2% reduction in draining tunnels
- 25.1% reduction in total lesion count
- 31.6% reduction in International Hidradenitis Suppurativa Score 4

These results suggest meaningful clinical benefits for vilobelimab in HS and support using a modified version of the HiSCR that measures drug activity against all three lesion types, emphasizing the reduction of draining tunnels. The company believes this analysis provides insights into vilobelimab's potential to address underlying inflammation in HS.