InflaRx N.V. - IFRX STOCK NEWS

InflaRx N.V. (Nasdaq: IFRX) reported Q1 2022 results highlighting significant progress in clinical studies for vilobelimab, particularly in severe COVID-19 and pyoderma gangrenosum. Phase III results showed a 23.9% reduction in 28-day all-cause mortality for COVID-19 patients, while a Phase IIa study in pyoderma gangrenosum indicated a strong response. The company has halted development in hidradenitis suppurativa and ANCA-associated vasculitis. Financially, net loss rose to €14 million, with available funds of €99.3 million expected to support operations into H2 2024.

InflaRx (Nasdaq: IFRX) announced promising results from its Phase III PANAMO study of vilobelimab for mechanically ventilated COVID-19 patients. The treatment showed a 23.9% relative reduction in 28-day all-cause mortality compared to placebo (p=0.094), with a 43% reduction noted in a subgroup analysis of Western European patients (p=0.014). Although the primary endpoint wasn't statistically significant, further subgroup analyses indicated potential benefits, especially in patients with higher disease severity. The company plans to discuss results with regulatory authorities and will host a conference call to elaborate on the findings.

InflaRx N.V. announced a corrected FDA advice letter for its vilobelimab Phase III trial in hidradenitis suppurativa, clarifying primary endpoint measures. Positive results in Phase IIa studies for pyoderma gangrenosum and ANCA-associated vasculitis were reported, with topline data from the COVID-19 trial expected by the end of March. The company has €26.2 million in cash and €84.4 million in financial assets. Despite significant net losses, financial backing of €43.7 million from the German government supports ongoing trials.

InflaRx N.V. (Nasdaq: IFRX) announced a corrected advice letter from the FDA regarding its Phase III clinical trial of vilobelimab for hidradenitis suppurativa. The FDA now recommends using the modified HiSCR (m-HiSCR) as the primary endpoint instead of the previously suggested HiSCR. This change raises hopes for further development in HS. InflaRx is assessing strategic options for vilobelimab, especially after positive results in related conditions like pyoderma gangrenosum. The company plans to provide a pipeline development update in Q2 2022.

InflaRx N.V. (Nasdaq: IFRX) will present final data from its Phase IIa study on vilobelimab for pyoderma gangrenosum at the 2022 AAD Annual Meeting from March 25-29 in Boston. Dr. Afsaneh Alavi will deliver a late-breaker presentation on March 26, focusing on updated outcomes from the trial. Vilobelimab, a monoclonal anti-C5a antibody, has shown positive results in previous trials and is being developed for various conditions, including COVID-19 and cutaneous squamous cell carcinoma.

InflaRx N.V. (Nasdaq: IFRX) announced a pause in its Phase III trial for vilobelimab in treating hidradenitis suppurativa (HS) after receiving unexpected feedback from the FDA. The FDA recommended using the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint, differing from prior guidance where InflaRx proposed a modified HiSCR. This new feedback emerged almost three months post-protocol submission. The FDA did not issue a clinical hold, and InflaRx plans to clarify the FDA's advice moving forward.

InflaRx (Nasdaq: IFRX) announced the continuation of a Phase II clinical trial for vilobelimab, an anti-inflammatory drug, in combination with pembrolizumab for cutaneous squamous cell carcinoma (cSCC). Three patients have safely completed 36 days of the first dosing cohort, prompting the Steering Committee to open enrollment for the second dosing cohort. Ongoing enrollment in vilobelimab monotherapy also shows no safety concerns. The trial aims to evaluate the drug's safety and effectiveness, with interim results expected in Q1 2023.

InflaRx N.V. (Nasdaq: IFRX) will present at the 11th Annual SVB Leerink Healthcare Conference, scheduled for February 14-18, 2022. CFO Thomas Taapken and Chief Strategy Officer Jordan Zwick will engage in a fireside chat on February 17 at 10:40 am EST. The event will be accessible via a live audio webcast on the InflaRx website. InflaRx focuses on targeting the complement system to develop anti-inflammatory therapeutics, specializing in C5a and C5aR inhibitors for various autoimmune diseases.

InflaRx N.V. (Nasdaq: IFRX) announced the initiation of regulatory discussions for its Phase I program concerning INF904, a novel oral small molecule inhibitor targeting C5aR. The company plans to commence the first-in-human study in the latter half of 2022. Recently granted a composition of matter patent for INF904, the drug has demonstrated strong anti-inflammatory effects in preclinical studies, showcasing a favorable safety profile and improved drug interactions compared to existing inhibitors. INF904 aims to treat chronic autoimmune and inflammatory diseases with ease of oral administration.