Summary of ABIVAX Conference Call - October 06, 2025 Company Overview - **Company**: ABIVAX (NasdaqGM:ABVX) - **Event**: Conference call discussing late-breaking abstracts presented at the UEG conference in Berlin Key Points Industry and Product Focus - **Product**: Oripazimod, a first-in-class molecule for treating ulcerative colitis (UC) [5][6] - **Target Population**: Patients with severe refractory ulcerative colitis, including those who have failed multiple therapies, including JAK inhibitors [9][10] Clinical Data Highlights - **Phase III Trials**: Two induction trials leading to a maintenance trial, with a focus on the most refractory patient population [7][8] - **Patient Severity**: Approximately 60% of patients had the highest endoscopic severity score (3) [10] - **Treatment History**: About 50% of patients had previously failed at least one advanced therapy, with a notable number being JAK refractory [10][11] - **Efficacy Metrics**: - Delta of 16% in clinical response for the 50 mg dose compared to placebo, and 13% for the 25 mg dose [11] - Significant endoscopic improvement observed, particularly in patients with high baseline severity [14][15] Safety and Tolerability - **Adverse Events**: Headaches were the most common side effect, with no significant difference in serious treatment-emergent adverse events between the treatment and placebo groups [20][21] - **Lipase Levels**: Elevations in lipase were noted but were below typical thresholds for clinical concern, with no associated abdominal pain or pancreatitis [78][79] Future Expectations and Positioning - **Maintenance Data**: Anticipated to be released next year, with expectations that it may show improved outcomes over Phase II data [77][78] - **Positioning in Treatment Spectrum**: The drug is expected to be positioned as a first-line treatment for naive patients and as an option for those with multiple therapy failures [36][40] - **Market Awareness**: Increased recognition and enthusiasm for oripazimod among clinicians, with a focus on its oral administration and potential to improve patient quality of life [90][91] Additional Insights - **Dosing Flexibility**: Emphasis on the ability to adjust dosing based on patient response and severity, with a preference for higher doses in refractory cases [66][67] - **Long-term Efficacy**: Historical data suggests that patients may continue to improve over time, indicating the need for longer observation periods in refractory populations [46][48] Conclusion - **Overall Sentiment**: Positive outlook on oripazimod's potential to become a leading treatment option for ulcerative colitis, with ongoing data collection and analysis to support its efficacy and safety profile [98][99]

Summary of ABIVAX (ABVX) Update / Briefing July 22, 2025 Company Overview - **Company**: ABIVAX (ABVX) - **Focus**: Development of therapies for ulcerative colitis, specifically through the Phase III Abtech induction trials Key Industry Insights - **Industry**: Biopharmaceuticals, specifically focusing on treatments for inflammatory bowel diseases (IBD) such as ulcerative colitis - **Market Context**: The results presented are significant as they come from one of the largest Phase III trials for ulcerative colitis, involving 1,275 patients across 36 countries Core Findings and Results - **Trial Overview**: The ATTeX trials were global studies enrolling 1,275 patients over 30 months, with participation from over 600 clinical sites [6] - **Efficacy**: The 50 mg dose of efasimod demonstrated a statistically significant and clinically meaningful efficacy with a 16.4% placebo-corrected remission rate [7][14] - **Safety Profile**: No new safety signals were observed, with a favorable safety profile and low discontinuation rates due to treatment-emergent adverse events [16] - **Statistical Significance**: The primary endpoint for clinical remission was met for the 50 mg dose with a statistically significant difference of 13.4% relative to placebo [13][14] - **Patient Population**: Nearly 50% of participants had prior inadequate responses to advanced therapy, with a significant portion being JAK inhibitor failures, marking it as the largest population of JAK failure patients in Phase III trials to date [12] Additional Insights - **Mechanism of Action**: The therapy is a first-in-class small molecule that resets the immune system balance rather than targeting specific inflammation, which is a unique approach in treating ulcerative colitis [21][22] - **Oral Administration**: The small molecule nature allows for oral administration, which is advantageous compared to monoclonal antibodies that may face absorption challenges in active colitis [22] - **Future Expectations**: The company anticipates that the positive induction results will translate into favorable maintenance outcomes, with the next significant milestone being the completion of the 44-week maintenance trial expected in Q2 2026 [18][78] Financial Considerations - **Funding Needs**: The company is looking to raise approximately $200 million to fund operations through the maintenance trial and beyond [83] - **Market Positioning**: The therapy is expected to be positioned earlier in treatment algorithms, potentially before injectable therapies, due to its favorable safety and efficacy profile [50][70] Conclusion - **Overall Sentiment**: The results from the Phase III trials are seen as a significant advancement for patients with ulcerative colitis, with strong efficacy and safety data supporting the potential for regulatory approval and market entry [103]