Core Points - The management call is focused on discussing the late-breaking ABTECT results presented at the UEG Conference in Berlin [2][3] - Key executives from the company, including the CEO, CMO, CFO, and Head of Medical Affairs, are participating in the call [2] - Dr. Marla Dubinsky, a notable expert in the field, is providing an overview of the data presented at the conference [3]

Core Viewpoint - Aston Martin has warned of a significant annual loss exceeding 110 million pounds ($147.81 million) due to weaker demand in North America and Asia Pacific, compounded by the impact of US tariffs, leading to a 10% drop in shares [1][2][5]. Group 1: Financial Performance - The annual loss is a sharp deterioration from earlier forecasts, where the company expected to break even in adjusted operating profit [2][5]. - Aston Martin's shares have decreased nearly 30% in value over the past 12 months, with current trading at 73.1 pence [4]. - The company now anticipates a mid-to-high single-digit percentage decline in 2025 volumes and has revised its capital spending plans, indicating no positive free cash flow generation in the second half of this year [4][5]. Group 2: Market Challenges - The company is facing a challenging environment due to the US tariff quota system, changes in ultra-luxury car taxes in China, and potential supply pressures following a cyber incident at Jaguar Land Rover [3][8]. - Aston Martin delivered approximately 1,430 wholesale units in the third quarter, which is below the guidance of being similar to the previous year's 1,641 units [8]. Group 3: Product Development - Deliveries of the Valhalla hypercar are expected to start in the fourth quarter with around 150 units, delayed due to vehicle engineering and regulatory approval processes, but a smooth delivery profile is anticipated in 2026 [9].

Core Insights - Abivax SA presented additional clinical data for obefazimod at the United European Gastroenterology Meeting, focusing on its efficacy for moderate-to-severely active ulcerative colitis [1][5] - The Phase 3 ABTECT trials demonstrated significant clinical response rates and safety profiles for obefazimod, indicating potential for market approval [2][4] Group 1: Efficacy Data - In the pooled ABTECT 1 & 2 trials, obefazimod 50mg achieved a placebo-adjusted clinical response improvement of 28% in patients without prior advanced therapy inadequate response (AT-IR) and 29% in those with up to four prior AT-IR [2] - The treatment also showed a 34% placebo-adjusted clinical response in participants who previously failed JAK inhibitor therapy, along with significant improvements in endoscopic and histologic endpoints [3] - The 50mg once-daily dose met the FDA primary endpoint of clinical remission at Week 8, with ABTECT-1 showing a 19.3% and ABTECT-2 showing a 13.4% placebo-adjusted clinical remission rate [5][6] Group 2: Safety Profile - Obefazimod was well-tolerated, with no new safety signals identified, and no serious, severe, or opportunistic infections or malignancies reported [4][5] - Both 25mg and 50mg doses demonstrated similar efficacy across clinical, endoscopic, and histological endpoints in participants without prior AT-IR [4] Group 3: Market Reaction - Following the positive data release, Abivax's stock price increased by 5.71%, reaching $88.72 [6]

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]

Efficacy of Obefazimod in Ulcerative Colitis - In pooled ABTECT 1 & 2 trials, Obefazimod 50mg demonstrated a statistically significant clinical remission rate, with a 16.4% difference compared to placebo (p<0.0001)[19] - Obefazimod 25mg also showed a statistically significant clinical remission rate, with a 13.2% difference compared to placebo (p<0.0001)[19] - The 50mg dose achieved clinically meaningful improvements in all clinical endpoints, regardless of prior advanced therapy inadequate response (AT-IR)[23] - In patients *with* prior AT-IR, Obefazimod 50mg showed a 31% improvement in clinical remission compared to placebo (p<0.0001)[24] - In patients *without* prior AT-IR, Obefazimod 50mg showed a 26% improvement in clinical remission compared to placebo (p<0.0001)[24] - The 50mg dose also achieved clinically meaningful improvements in endoscopic and histologic endpoints regardless of prior AT-IR[27] - Clinical response with the 50mg dose was consistent across subgroups, including those with no prior AT-IR through 4+ AT-IR or JAK-IR[31] Safety Profile of Obefazimod - In the pooled ABTECT 1 & 2 full dataset, the most common treatment-emergent adverse event (TEAE) was headache, with an incidence of 24.1% in the Obefazimod 50mg group[36] - The rate of TEAEs leading to study drug discontinuation was 5.0% in the Obefazimod 50mg group[35] - Serious TEAEs occurred in 3.1% of patients in the Obefazimod 50mg group[35]

Core Insights - Abivax announced additional clinical data for obefazimod at the UEG Meeting, highlighting its efficacy in treating moderate-to-severely active ulcerative colitis [2][3] - The Phase 3 ABTECT trials demonstrated that obefazimod achieved clinically meaningful improvements across various patient subgroups, including those with prior inadequate responses to advanced therapies [4][7] Study Population - A total of 1272 patients were enrolled in the ABTECT trials, with approximately 60% having an endoscopic subscore of 3 [3] - About 47% of the total population had a prior inadequate response to advanced therapy, with 21% having failed to respond to a JAK inhibitor [3] Efficacy Results - The 50 mg dose of obefazimod showed clinically meaningful improvements in clinical remission, with a placebo-adjusted difference of 10% for patients with prior inadequate response (p=0.0009) and 22% for those without (p<0.0001) [4][7] - In participants without prior inadequate response, the 50 mg dose achieved a placebo-adjusted difference in clinical response of 28% (p<0.0001), while those with four or more prior inadequate responses showed a 29% difference (p=0.0242) [4][7] - The treatment also demonstrated a 34% improvement in clinical response for participants who previously failed JAK inhibitor therapy (p=0.0017) [4][7] Safety Profile - Obefazimod was well tolerated, with no new safety signals identified for both the 25 mg and 50 mg doses [4][7] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [9]

Core Insights - Abivax announced results from the Phase 3 ABTECT 8-Week Induction Trials for obefazimod, aimed at treating moderate-to-severely active ulcerative colitis, during the UEG Meeting in Berlin [2][3] - The trials demonstrated significant clinical remission rates and safety data, highlighting the need for new therapies in this area [3][5] Group 1: Trial Results - A total of 1,272 patients were enrolled in the ABTECT 1 & 2 trials, with a pooled clinical remission rate of 16.4% (p<0.0001) at the 50 mg once-daily dose at Week 8 [3][5] - ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001), while ABTECT-2 demonstrated a rate of 13.4% (p=0.0001) at the same dosage [3][5] - All key secondary efficacy endpoints were met in both trials, indicating robust performance of obefazimod [5] Group 2: Safety Profile - No signals for serious, severe, or opportunistic infections or malignancies were observed in the trials [3][5] - The most commonly reported treatment-emergent adverse events (TEAEs) included headache (16% at 25 mg, 24.1% at 50 mg) and nausea (5% at 25 mg, 7.2% at 50 mg), with low discontinuation rates due to headaches [3][5] Group 3: Future Developments - Abivax plans to present a second late-breaking abstract on October 6, 2025, and will host a conference call to discuss the topline results [4][5] - The company is focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [2][6]

Core Insights - ABIVAX Société Anonyme is recognized as one of the 12 best performing healthcare stocks currently available for investment [1] - The company is focused on developing therapies for chronic inflammatory diseases, with its lead candidate, obefazimod, in advanced clinical trials [1] Group 1: Clinical Development - ABIVAX is a clinical-stage biotechnology company developing obefazimod, an oral miR-124 enhancer, which is currently in Phase 3 trials for ulcerative colitis (UC) and Phase 2b trials for Crohn's disease [1] - In July 2025, ABIVAX reported positive topline data from two Phase 3 induction trials in moderate to severe UC, showing a pooled clinical remission rate 16.4% higher than placebo, with the 50 mg dose achieving a 19.3% placebo-adjusted remission rate [3] - The company plans to submit U.S. and European regulatory applications in the second half of 2026 based on ongoing maintenance studies [3] Group 2: Upcoming Events - ABIVAX announced it will present late-breaking data from the ABTECT Phase 3 induction trials at the United European Gastroenterology (UEG) Congress in Berlin on October 6, 2025 [2] - The presentation will focus on eight-week efficacy results of obefazimod, including outcomes in patients who previously did not respond to advanced therapies [2] - An investor call and symposium on new treatment mechanisms for UC will be hosted alongside the congress [2] Group 3: Financial Position - To support its late-stage programs, ABIVAX strengthened its financial position with a $650 million (€554 million) public offering in July 2025 [4] - This funding extends the company's cash runway into the fourth quarter of 2027, enhancing investor confidence as it advances obefazimod toward potential approval and commercialization [4]

Core Insights - Abivax announced the acceptance of an additional late-breaking abstract for its lead drug candidate, obefazimod, to be presented at the 2025 United European Gastroenterology Congress, highlighting its significance in treating moderately to severely active ulcerative colitis [1][2] Group 1: Presentation Details - The late-breaking abstract titled "EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS" will be presented on October 5, 2025, at 5 PM CEST [1] - The presentation will include results from two Phase 3 randomized, double-blind, placebo-controlled, 8-week induction trials (ABTECT-1 & 2) [1][3] Group 2: Clinical Significance - The results from the ABTECT Phase 3 induction trials demonstrate statistically significant and clinically meaningful activity, along with an impressive safety and tolerability profile for obefazimod [2] - These findings are seen as crucial steps towards providing a novel, first-in-class oral treatment option for patients with ulcerative colitis [2] Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapies that stabilize the immune response in patients with chronic inflammatory diseases [5] - The company is based in France and the United States, with obefazimod currently in Phase 3 clinical trials for ulcerative colitis [5]

Core Insights - Abivax announced the presentation of a late-breaking abstract for its lead drug candidate, obefazimod, at the United European Gastroenterology Congress, highlighting its potential as a new treatment for moderately to severely active ulcerative colitis [2][3] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing innovative therapies for chronic inflammatory diseases, with obefazimod (ABX464) currently in Phase 3 clinical trials for ulcerative colitis [10] Upcoming Events - The late-breaking abstract titled "EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES" will be presented on October 6, 2025, at 10 AM CET [7] - Abivax management will hold an analyst and investor call on October 6 at 3 PM CET to discuss the data [8] - A symposium titled "From Evolution to Revolution: New Mechanisms in Ulcerative Colitis" will take place on October 6 from 5:30 PM to 6:30 PM CET [8]