JENA, Germany, Oct. 21, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced its participation in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference. Details are as follows: Guggenheim Securities 2nd Annual Healthcare Innovation ConferenceNovember 10 - 12, 2025 in Boston, MAFireside chat on November 11 at 2:30 PM ET InflaRx will also conduct one-on-one investor meetin ...

Core Points - InflaRx N.V. has regained compliance with Nasdaq's minimum bid price requirement as of September 11, 2025, after its ordinary shares closed at $1.00 or greater for 10 consecutive business days from August 27, 2025, to September 10, 2025 [1][2] Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system, specifically through its proprietary anti-C5a and anti-C5a receptor technologies [3] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody that has shown disease-modifying clinical activity and tolerability in multiple studies [3] - InflaRx is also working on INF904, an orally administered small molecule inhibitor targeting C5a-induced signaling via the C5a receptor [3] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [4]

Summary of InflaRx Conference Call Company Overview - **Company**: InflaRx - **Key Participants**: CEO Niels Reidemann, CFO Thomas Tapkin, Head of IR John Medina - **Event**: Cantor Global Healthcare Conference Industry and Product Focus - **Industry**: Biotechnology, specifically focusing on drug development for inflammatory diseases - **Key Products**: - Small oral RavA receptor antagonist with promising Phase I data - Antibody drug targeting C5a with emergency use authorization in the U.S. and approval in Europe for ARDS Core Points and Arguments 1. **Upcoming Data Releases**: InflaRx is expecting significant data releases in October for two indications: Hidradenitis Suppurativa (HS) and Chronic Spontaneous Urticaria (CSU) [3][4] 2. **Differentiated Mechanism**: The small molecule is designed to achieve 90%-100% pathway blockage, which is a significant improvement over previous generations [8][9] 3. **Phase I Data**: Phase I data showed a 10x increase in area under the curve and a 3x peak concentration, indicating rapid therapeutic exposure [8][9] 4. **Trial Objectives**: The company aims to demonstrate that their drug is active and differentiated from placebo within four weeks of treatment [11][12] 5. **Focus on Lesion Reduction**: In HS, the focus will be on lesion reduction, particularly in draining tunnels, which traditionally show little to no placebo response [15][19] 6. **Potential for Phase II Trials**: The outcome of the current trials will determine the design and funding for potential Phase II trials, with interest from both investors and large pharma companies [22][23] 7. **Partnership Opportunities**: InflaRx is open to partnerships to address cash needs for future studies, especially if data is promising [23][25] 8. **COVID-19 Treatment**: The company is working with the FDA for broader labeling of their ARDS drug, which could be significant for pandemic preparedness [39][40] 9. **China Partnership**: InflaRx has a partnership in China for ANCA vasculitis, with rapid study progress and a single-digit royalty structure [46][47] 10. **PG Study Update**: The company is analyzing data from a recent study that did not meet interim criteria, with plans to discuss findings with the FDA [49][50] Additional Important Insights - **Safety Profile**: The drug has shown no known safety issues in long-term studies, which could provide a competitive advantage [33][34] - **Market Need**: There is a significant unmet medical need in HS and CSU, with patients often becoming refractory to existing treatments [35][36] - **Regulatory Environment**: The company is actively engaging with regulatory bodies to facilitate drug approvals, particularly in rare diseases [57][58] This summary encapsulates the key points discussed during the conference call, highlighting InflaRx's strategic focus, product pipeline, and market opportunities.

Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [3] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, which has shown disease-modifying clinical activity and tolerability in multiple studies [3] - InflaRx is also working on INF904, an orally administered small molecule inhibitor of C5a-induced signaling [3] Upcoming Events - InflaRx will participate in the Cantor Global Healthcare Conference from September 3 to 5, 2025, with a fireside chat scheduled for September 4 at 9:10 AM ET [1] - The company will also conduct one-on-one investor meetings on September 4 during the Cantor conference [1] - Additionally, InflaRx will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025, with a presentation on September 9 at 3:30 PM ET [2] - One-on-one investor meetings will also take place on September 9 at the H.C. Wainwright conference [2]

Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [2] - The company utilizes proprietary anti-C5a and anti-C5a receptor technologies to create specific inhibitors of the complement activation factor C5a [2] - InflaRx has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, which has shown disease-modifying clinical activity in multiple studies [2] Upcoming Financial Results - InflaRx will report its second quarter 2025 financial and operating results on August 7, 2025, before the market opens [1] - No conference call is planned for this earnings report [1] Product Development - InflaRx is also developing INF904, an orally administered small molecule inhibitor targeting C5a-induced signaling [2] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [2][3]

Core Points - InflaRx N.V. has received a notice from Nasdaq indicating that its common shares have closed below the minimum bid price of $1.00 for the last 30 consecutive business days [1] - The company has until January 7, 2026, to regain compliance with the Minimum Bid Price Rule, with the possibility of transferring to the Nasdaq Capital Market for an additional compliance period [2] - The notice does not have an immediate effect on the listing or trading of the company's shares, and InflaRx plans to monitor its share price and explore options for compliance [3] Company Overview - InflaRx is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system, specifically through its proprietary anti-C5a and anti-C5a receptor technologies [4] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, and is also working on INF904, an orally administered small molecule inhibitor [4] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [5]

Financial Data and Key Metrics Changes - The company has a strong balance sheet and is funded into 2027, indicating financial stability to reach upcoming milestones [5] - The company is focusing on a new small molecule, INF904, which is expected to address significant market needs in immunodermatology [4] Business Line Data and Key Metrics Changes - INF904 is currently undergoing phase 2a studies for chronic spontaneous urticaria and hidradenitis suppurativa, targeting large unmet medical needs in these areas [9][22] - The company has a commercial angle with Cohibic, a C5a antibody, which has received emergency use authorization for critically ill COVID patients in the US and has recently been approved in Europe [10][11] Market Data and Key Metrics Changes - The immunodermatology market is identified as a billion-dollar market with significant unmet medical needs that INF904 could address [11][29] - The company is exploring potential collaborations to expand its market reach beyond dermatology [5][11] Company Strategy and Development Direction - The company is targeting the C5aR pathway with INF904, which is believed to have best-in-class potential due to its differentiated pharmacokinetic and pharmacodynamic profiles compared to existing treatments [14][20] - The strategic focus includes establishing a network of experts and strong intellectual property coverage in the immunodermatology space [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of INF904 to provide a new mode of action in treating chronic spontaneous urticaria and hidradenitis suppurativa, which are currently underserved by existing therapies [12][29] - The management highlighted the importance of addressing both IgE-mediated and autoimmune pathways in their treatment approach, which could significantly enhance the drug's market potential [42][50] Other Important Information - The company has established a differentiated profile for INF904, including a higher maximum concentration and broader therapeutic index compared to the marketed comparator, Avacopan [16][20] - The ongoing phase 2 studies are designed to assess safety, pharmacokinetics, and efficacy in targeted patient populations [22][24] Q&A Session Summary Question: What is the expected market potential for INF904? - The market potential for chronic spontaneous urticaria could exceed $1 billion per year, addressing significant unmet needs in the patient population [29] Question: How does INF904 differentiate from existing treatments? - INF904 has a three-fold higher Cmax and a ten-fold higher area under the curve compared to Avacopan, indicating a potentially more effective treatment profile [16][20] Question: What are the primary endpoints for the ongoing studies? - The primary endpoints include the urticaria activity score seven, focusing on safety and efficacy in the targeted patient populations [24][38]

Core Viewpoint - InflaRx N.V. announced the termination of the Phase 3 trial for vilobelimab in pyoderma gangrenosum due to futility as recommended by the Independent Data Monitoring Committee (IDMC) [1][2] Group 1: Trial and Development Updates - The IDMC's recommendation was based on an analysis of the first 30 patients, with no unexpected adverse events reported [2] - InflaRx will discontinue further development of vilobelimab for pyoderma gangrenosum and will focus on INF904, with Phase 2a data readouts expected in chronic spontaneous urticaria and hidradenitis suppurativa this summer [2] - The company is considering additional cost savings and resource redirection to extend its cash runway [3] Group 2: Regulatory and Market Status - GOHIBIC (vilobelimab) is still available in the U.S. under Emergency Use Authorization for COVID-19 in hospitalized adults [3] - In the EU, GOHIBIC has received marketing authorization under exceptional circumstances for treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome [4] - InflaRx is exploring commercial partnerships and distribution options in the EU without expecting a negative impact on its cash burn rate [4] Group 3: Financial Position - In February, InflaRx completed a public offering of 8.25 million shares at $2.00 per share, raising approximately $30 million in gross proceeds [4] - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling €65.7 million, indicating sufficient funds for planned operations into 2027 [7] Group 4: Stock Performance - Following the announcement, IFRX stock experienced a significant decline of 52.8%, trading at $0.86 during the premarket session [5]

Core Viewpoint - InflaRx N.V. announced the discontinuation of the Phase 3 trial for vilobelimab in pyoderma gangrenosum due to futility, based on an interim analysis of the first 30 patients, with no unexpected adverse events reported [1][2] Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics targeting the complement system, specifically through its proprietary anti-C5a and anti-C5aR technologies [5] - The lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody that has shown clinical activity in various studies [5][17] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [5] Product Development - Following the trial's discontinuation, InflaRx will prioritize resources on INF904, an oral inhibitor of C5aR, with Phase 2a data readouts expected in chronic spontaneous urticaria and hidradenitis suppurativa this summer [2] - The company is also considering cost-saving measures to extend its cash runway [2] Regulatory Status of Vilobelimab - Vilobelimab (GOHIBIC) has received Emergency Use Authorization from the FDA for treating COVID-19 in hospitalized adults when initiated within 48 hours of invasive mechanical ventilation or ECMO [3][7] - In the EU, vilobelimab has been granted marketing authorization under exceptional circumstances for treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome who are receiving systemic corticosteroids and invasive mechanical ventilation [4][9] Clinical Trial Results - The EU approval of vilobelimab is supported by results from the Phase 3 PANAMO trial, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo in invasively mechanically ventilated COVID-19 patients [9][10]

Core Insights - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics targeting the complement system [1][5] - The company will participate in several investor conferences in June and July 2025, including presentations and one-on-one meetings [1][2][3][4] Company Overview - InflaRx specializes in anti-C5a and anti-C5aR technologies to create inhibitors for the complement activation factor C5a, which is linked to various inflammatory diseases [5] - The lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody that has shown clinical activity and tolerability in multiple studies [5] - InflaRx is also developing INF904, an orally administered small molecule inhibitor of the C5a receptor [5] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [5][6] Upcoming Events - InflaRx will present at the Jefferies Global Healthcare Conference from June 3-5, 2025, with a presentation scheduled for June 4 at 7:35 AM ET [2] - The company will participate in the Oppenheimer Innovators in I&I Summit on June 25, 2025, focusing on advances in dermatology [3] - InflaRx will also attend the Leerink Partners Therapeutics Forum on July 8-9, 2025, with one-on-one investor meetings on June 8 [4]