Core Insights - InflaRx N.V. announced positive topline data from a Phase 2a basket study of INF904 for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), indicating strong efficacy and safety profiles [1][2][19] - The company plans to advance INF904 into Phase 2b trials in HS and expand its clinical program in CSU, highlighting the drug's potential as a "pipeline-in-a-product" [2][11][20] Phase 2a Data in HS - The Phase 2a trial involved 31 HS patients, with efficacy data reported from 29 patients across three dosing cohorts: 60 mg BID, 90 mg BID, and 120 mg BID [3][12] - Key clinical endpoints included reductions in abscesses and nodules (AN), draining tunnels (dT), and improvements in pain and quality of life measures [4][5][10] - INF904 demonstrated rapid and consistent reductions in ANs and dTs, with the highest dosing cohort showing the strongest clinical activity [5][6][10] - Safety data indicated no serious adverse events, with only mild adverse events reported [9][10] Phase 2a Data in CSU - The Phase 2a trial for CSU included 31 patients, with efficacy data reported from 30 patients across 60 mg BID and 120 mg BID dosing cohorts [15][22] - Clinical endpoints included changes in the Urticaria Activity Score (UAS7) and Urticaria Control Test (UCT7), with significant reductions observed, particularly in patients with severe CSU [17][19][22] - Safety data showed no serious adverse events, reinforcing the drug's safety profile [19][22] Market Potential - InflaRx estimates the addressable market for INF904 could exceed $1 billion, emphasizing the need for novel therapies in HS and CSU [11][20] - The company is actively engaging with potential collaborators to expedite development goals for INF904 [6][20] Future Plans - InflaRx aims to complete the 4-week post-treatment observation period and present final results at major scientific meetings [1][22] - A Capital Markets Event is planned to showcase the potential of INF904 [1][2]

Core Insights - Several biotechnology and pharmaceutical stocks experienced significant price increases during after-hours trading, driven by upcoming data releases, recent earnings reports, and prior corporate updates [1] Company Summaries - InflaRx N.V. (IFRX) saw a surge of 63.41% to $2.01 after hours, following a 2.50% gain at the close, due to plans to release topline data from its Phase 2a trial of oral C5aR inhibitor INF904, expected on Monday morning alongside its third-quarter financial results [2] - Rallybio Corp. (RLYB) rose 12.84% to $0.71 after reporting a third-quarter net income of $16.0 million, or $0.36 per share, reversing a prior-year loss of $11.5 million, although revenue for the quarter was $0.2 million, slightly below the $0.3 million reported in the same period last year [3] - FibroBiologics Inc. (FBLG) climbed 13.51% to $0.40 after hours, building on a 5.13% gain during regular trading, following the release of its third-quarter financial results and a corporate update on October 31 [4] - AbCellera Biologics Inc. (ABCL) advanced 6.51% to $4.16 after hours, recovering from a 13.69% decline earlier in the day, reporting a third-quarter net loss of $57.1 million, or $(0.19) per share, compared to a loss of $51.1 million in the same quarter last year, while revenue increased to $9.0 million from $6.5 million year-over-year [5] - BioRestorative Therapies Inc. (BRTX) gained 11.68% to $1.53 in after-hours trading, following a Notice of Allowance from the Japanese Patent Office for its ThermoStem platform announced on October 27, with third-quarter results scheduled for release on November 12 [6] - Cellectis S.A. (CLLS) rose 6.58% to $3.40 after hours, reporting a third-quarter net income of $589 thousand, or $0.01 per share, compared to a $23.1 million loss in the prior year, with total revenues and other income more than doubling to $37.2 million from $18.1 million [7]

Core Insights - InflaRx N.V. is set to report topline data from its Phase 2a clinical trial of oral C5aR inhibitor INF904 for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) on November 10, 2025 [1] - The company will host a webcast/conference call on the same day to discuss the clinical data and feature insights from key opinion leaders [2] - InflaRx will also publish its third quarter 2025 financial and operating results via Form 6-K on the same day [3] Company Overview - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary anti-C5a and anti-C5aR technologies to develop specific inhibitors targeting the complement activation factor C5a and its receptor C5aR [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]

Core Insights - InflaRx N.V. is participating in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference scheduled for November 10 - 12, 2025, in Boston, MA, with a fireside chat on November 11 at 2:30 PM ET and one-on-one investor meetings on the same day [1] Company Overview - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary anti-C5a and anti-C5a receptor technologies to develop specific inhibitors targeting the complement activation factor C5a [2] - 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 [2] - InflaRx is also working on INF904, an orally administered small molecule inhibitor that targets C5a-induced signaling via the C5a receptor [2] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [3]

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]