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]

ABTECT Phase 3 Program Overview - The ABTECT Phase 3 program included 2 induction trials (ABX464-105, ABX464-106) and 1 maintenance trial (ABX464-107) [25] - The trials enrolled 1,275 patients across 36 countries [20, 60] - The trials included both advanced therapy naïve (52.7%) and refractory patients (47.3%) [60] Efficacy Results - In ABTECT 1 (Study 105), the 50mg dose of obefazimod achieved a clinical remission rate of 21.7%, a 19.3% difference compared to placebo (2.5%) (p<0.0001) [33, 60] - In ABTECT 2 (Study 106), the 50mg dose of obefazimod achieved a clinical remission rate of 19.8%, a 13.4% difference compared to placebo (6.3%) (p=0.0001) [40, 60] - Pooled analysis of ABTECT 1 & 2 showed a clinical remission rate of 20.8% with 50mg obefazimod, a 16.4% difference compared to placebo (4.4%) (p<0.0001) [47, 60] - In ABTECT 1, the 25mg dose of obefazimod achieved statistically significant results on all key secondary endpoints [36] - In ABTECT 2, the 50mg dose of obefazimod achieved statistical significance on all key secondary endpoints [43] Safety and Tolerability - Obefazimod was generally well tolerated with no new safety signals observed in Phase 3 induction trials [20, 60] - In ABTECT 1, Any TEAE was 46.9% for Obe 25 mg, 59.4% for Obe 50 mg, and 53.2% for Placebo [52] - In ABTECT 2, Any TEAE was 50.9% for Obe 25 mg, 61.0% for Obe 50 mg, and 48.4% for Placebo [52] Next Steps - 44-week maintenance data is expected in Q2 2026 [25, 60]

Core Insights - Abivax announced positive topline results from its Phase 3 ABTECT-1 and ABTECT-2 trials for obefazimod, a first-in-class oral miR-124 enhancer, in patients with moderately to severely active ulcerative colitis [2][3][4] Study Details - The ABTECT-1 and ABTECT-2 trials were global, multicenter, randomized, double-blind, placebo-controlled studies assessing once-daily oral administration of obefazimod at 25 mg or 50 mg doses [4][5] - A total of 1,275 patients were enrolled from over 600 clinical trial sites across 36 countries, making it one of the largest Phase 3 ulcerative colitis trials conducted [4][5][6] Efficacy Results - The 50 mg once-daily dose of obefazimod achieved a pooled placebo-adjusted clinical remission rate of 16.4% (p<0.0001) at Week 8 [5][7] - Individually, the 50 mg dose showed a remission rate of 19.3% (p<0.0001) in ABTECT-1 and 13.4% (p=0.0001) in ABTECT-2 [5][7] - The 25 mg dose achieved a placebo-adjusted remission rate of 21.4% in ABTECT-1, while in ABTECT-2 it did not reach statistical significance but indicated a strong clinical response [8] Safety Profile - Obefazimod demonstrated a favorable safety profile with no new safety signals observed, and the treatment was generally well tolerated across both dose groups [9][10] - Treatment Emergent Adverse Events (TEAEs) were reported in 59.4% of patients receiving the 50 mg dose in ABTECT-1 and 61.0% in ABTECT-2 [10][11] Future Plans - The ongoing ABTECT Maintenance Trial is expected to report topline results in Q2 2026, which will support regulatory filings globally [12][16] - Pending successful results from the maintenance trial, Abivax plans to submit a New Drug Application to the FDA and a Marketing Authorization Application to the EMA in the second half of 2026 [3][16]

Core Viewpoint - The article emphasizes the focus on non-consensus long-short investment ideas within the biotechnology sector, particularly targeting small to mid-cap companies in the US and EU markets [1]. Group 1: Investment Focus - The company specializes in identifying clinical catalysts and capitalizing on earnings from new drug launches [1]. - The investment strategy is centered around biotechnology firms that are publicly traded, indicating a preference for companies with potential growth opportunities [1]. Group 2: Analyst's Position - The analyst holds a beneficial long position in the shares of ABVX, indicating a personal investment interest in this specific company [2]. - The article is authored by the analyst without external compensation, suggesting an independent viewpoint [2]. Group 3: Disclaimer and Limitations - The content is strictly for informational and educational purposes, and should not be interpreted as financial or investment advice [3][4]. - There are no guarantees regarding the accuracy or reliability of the information provided, and readers are encouraged to conduct their own due diligence [3][4].

Group 1 - The core focus of Abivax is on developing therapeutics that modulate the inflammatory response in patients with chronic inflammatory diseases [1][3] - The annual general meeting of shareholders was held on June 6, 2025, chaired by Sylvie Grégoire [1][2] - All resolutions proposed by the Board were adopted, including the financial statements for the 2024 financial year and the compensation policy for key executives [2] Group 2 - Sylvie Grégoire was ratified as Chairman, and Dominik Höchli, MD, was appointed as a Board member [2] - Abivax's lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for treating moderately to severely active ulcerative colitis [3]

Core Viewpoint - Abivax SA reported its financial results for the first quarter of 2025, highlighting a decrease in total operating income and an increase in operating loss, primarily driven by rising research and development expenses [2][3][7]. Financial Highlights - Total operating income for Q1 2025 was €1.0 million, down from €1.2 million in Q1 2024, reflecting a decrease of €0.2 million [3][7]. - Total operating expenses increased, with research and development costs rising to €39.3 million from €35.7 million, an increase of €3.6 million [3][7]. - The operating loss for the quarter was €47.2 million, compared to €44.7 million in the same period last year, marking an increase of €2.5 million [3][7]. - The net loss for the period was €52.4 million, up from €42.9 million in Q1 2024, indicating a rise of €9.5 million [3][7]. Balance Sheet Overview - As of March 31, 2025, the net financial position was €18.5 million, a decrease of €34.9 million from €53.4 million at the end of 2024 [3][5]. - Cash and cash equivalents stood at €103.6 million, down from €144.2 million at the end of 2024, reflecting a decrease of €40.6 million [5][7]. - Total assets decreased to €166.9 million from €205.2 million, a reduction of €38.3 million [5]. Research and Development Focus - R&D expenses increased significantly, with a €3.0 million (736%) rise related to the Crohn's Disease clinical program, driven by the progression of Phase 2b clinical trials for obefazimod [7]. - A €2.7 million (78%) increase in transversal activities was noted, attributed to the expansion of the R&D headcount and new equity awards [7]. - There was a decrease of €1.3 million (-4%) in expenses related to the Ulcerative Colitis clinical program as Phase 3 trials reached full enrollment [7]. Operational Updates - Abivax is focused on developing therapeutics for chronic inflammatory diseases, with its lead drug candidate, obefazimod, currently in Phase 3 clinical trials for ulcerative colitis [2][8]. - The company anticipates being able to finance its operating cash flow requirements into the fourth quarter of 2025 based on current funds and operating assumptions [6].

Core Viewpoint - Abivax has completed enrollment for the Phase 3 ABTECT trials in patients with moderately to severely active ulcerative colitis, marking a significant milestone for the company and the patient community [2][3]. Group 1: Trial Enrollment and Characteristics - A total of 1,275 participants were successfully enrolled in the Phase 3 ABTECT trials, exceeding the target enrollment of 1,224 by 4% [6]. - The blinded baseline characteristics of participants in the Phase 3 ABTECT trials closely align with those observed in the Phase 2b trial, reinforcing confidence in the drug's potential efficacy and safety [3][9]. - Key baseline characteristics include: - 65% of participants had a baseline MMS score of 7-9 in Phase 3 compared to 71% in Phase 2b - 48% had prior advanced therapy in both trials - 42% of Phase 3 participants had previously failed corticosteroid treatment, compared to 52% in Phase 2b [3][6]. Group 2: Upcoming Milestones - Top-line results from the 8-week induction trials are anticipated in Q3 2025, with 44-week maintenance data expected in Q2 2026 [6][9]. - If the results confirm the safety and efficacy of obefazimod, a New Drug Application (NDA) submission to the FDA is planned for the second half of 2026 [3][9]. Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [7]. - The lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis [7].

Core Points - Abivax is advancing towards key operational milestones in 2025, including the ongoing Phase 3 ABTECT clinical program [3][7] - The Annual General Meeting is scheduled for June 6, 2025, in Paris, France [1][7] - The company aims to complete enrollment for induction trials in Q2 2025, with top-line data expected in Q3 2025 [3][7] - The CEO of Abivax, Marc de Garidel, expressed confidence in the company's long-term value, highlighting a personal investment of approximately 120,000 shares in Q1 2025 [4] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics for chronic inflammatory diseases [5] - The lead drug candidate, obefazimod (ABX464), is currently in Phase 3 trials for moderately to severely active ulcerative colitis [5]

Core Insights - Abivax has appointed Dr. Dominik Höchli to its Board of Directors, bringing extensive experience in immunology and biopharma, particularly from his 20-year tenure at AbbVie/Abbott [1][2][4] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [5] - The company's lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis [5] Leadership Experience - Dr. Höchli has over two decades of leadership experience in global biopharma, including roles as Vice President of Global Marketing for Immunology and Head of Global Medical Affairs at AbbVie [2][3] - He also served as Interim CEO of Catapult Therapeutics and is the founder of Abinode, a pharmaceutical strategy consulting firm [3] Strategic Importance - The appointment of Dr. Höchli is seen as pivotal for Abivax as it approaches key clinical and regulatory milestones for obefazimod, with a Phase 3 data readout for ulcerative colitis expected in Q3 2025 [2][4]

Financial Performance - The company reported net losses of €176.2 million, €147.7 million, and €60.7 million for the years ended December 31, 2024, 2023, and 2022, respectively[40]. - As of December 31, 2024, the company had accumulated tax losses of €609.4 million[40]. - The company has no approved products and has not generated any revenue from product sales to date[37]. - The company anticipates that research and development expenditures will substantially increase in 2025 due to ongoing clinical trials[48]. - The company faces substantial doubt about its ability to continue as a going concern without additional funding[46]. Funding and Financial Strategy - The company has existing cash and cash equivalents of €144.2 million as of December 31, 2024, and anticipates funding its cash flow requirements into the fourth quarter of 2025[47]. - The company plans to seek additional financing through public or private equity, debt financings, or collaborations, as it may never generate sufficient product revenue[49]. - The company entered into a framework subscription agreement allowing for up to €75 million in structured debt financing, all drawn as of the report date[65]. - The company has significant debt commitments that require compliance with operating covenants, with potential consequences for non-compliance[65]. Clinical Development and Regulatory Challenges - The company is focused on the timely and successful completion of clinical development for obefazimod, its lead drug candidate[39]. - The success of the drug candidates, particularly obefazimod, is uncertain and dependent on regulatory approval, which has not yet been obtained[83]. - The authorization process for drug candidates is lengthy, expensive, and uncertain, with no guarantee of success[85]. - Clinical trials may face delays due to difficulties in patient recruitment and regulatory requirements, impacting financial resources[78]. - Regulatory authorities may impose additional studies or requirements, potentially delaying or discontinuing product development[80]. Market and Competitive Landscape - The company faces intense downward pressure on healthcare costs, leading to high barriers for new product entry and potential changes in accepted pricing and reimbursement rates[103]. - The company faces competition from established pharmaceutical companies, which may impact the adoption and sales of its drug candidates[136]. - New market entrants and increased competition could adversely affect the company's financial position and growth outlook[166]. Intellectual Property Risks - The company faces risks related to potential misconduct by employees and third parties, which could lead to regulatory penalties[161]. - The company faces risks related to intellectual property rights, including potential challenges in maintaining patent protection and the possibility of competitors circumventing these rights[203]. - The patents protecting obefazimod's composition of matter are set to expire in 2030, and the patents for its methods of use will expire in 2035, posing a risk to its successful commercialization[224]. Operational and Compliance Challenges - The company has material weaknesses in its internal controls over financial reporting, which could adversely affect its financial reporting accuracy[55]. - The company may face challenges in maintaining adequate internal controls over financial reporting due to growth pressures and regulatory compliance requirements[62]. - Compliance with stringent regulatory standards (GLP, GCP) is critical; failure could lead to unreliable data and additional trials[151]. External Factors and Economic Conditions - Global economic conditions, including geopolitical developments and public health crises, could materially adversely impact demand for the company's drug candidates[137]. - The ongoing war between Ukraine and Russia has caused significant implications for the global economy, particularly affecting energy, raw materials, and food supply, leading to stock market volatility[201]. - The company has decided not to include Russia and Belarus in its global Phase 3 program for obefazimod due to the conflict, which may impact access to raw materials and logistics[201]. Cybersecurity and Data Risks - Cybersecurity threats pose risks to the company's sensitive data and information technology systems, potentially leading to operational disruptions and reputational harm[186]. - The reliance on third-party service providers introduces additional cybersecurity risks, as their security measures may not be adequate[190]. Human Resources and Organizational Challenges - The company’s growth strategy may be hindered by difficulties in managing expansion and recruiting qualified personnel, potentially affecting operational efficiency[129]. - Competition for hiring qualified personnel is intense, which may hinder the company's ability to achieve its objectives[159]. - The company faces challenges in recruiting, training, and retaining effective sales and marketing personnel, which may hinder product distribution and physician engagement[168].