{"success":true,"data":{"pressRelease":{"id":"148906","rtpr_id":"nGNX8GSJwt-20260921","ticker":"ABVX","exchange":"Euronext Paris","all_tickers":["ABVX"],"title":"Abivax Presents Business Updates and First Half 2026 Financial Results ","author":"Globe Newswire","published_at":"2026-09-21T20:05:00.424Z","article_body":"Abivax Presents Business Updates and First Half 2026 Financial Results \n* Chris Rabbat to succeed Fabio Cataldi as Chief Medical Officer; Tim Kelly\nappointed Chief Technical Officer to advance commercial supply readiness and\nlead Abivax’s Chemistry, Manufacturing and Controls (“CMC”), Quality and\nInformation Technology (“IT”) functions\n\n\n* Cash, cash equivalents and short-term investments of €402.4 million as of\nJune 30, 2026, combined with €767.1 million in net proceeds from the early\nJuly underwritten public offering, provides cash runway into Q4 2029\n\n\n* Royalty certificates buy-back completed in Q2 2026 materially reduces\nroyalty overhang, further strengthening Abivax’s debt-free financial\nposition and flexibility to support future commercialization efforts\nPARIS, France – September 21, 2026 – 10:05 PM CEST – Abivax SA\n(https://www.globenewswire.com/Tracker?data=x6zZ2FmIADrE21vAzvJxjHEAZlZ2n5S22c_hexKznbTF3KZIbCB2cjOELkTHfoXOPDmOPSfxBfM4innV1fPC5w==)\n(Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the\n“Company”), a clinical-stage biotechnology company focused on developing\ntherapeutics that harness the body’s natural regulatory mechanisms to\nstabilize the immune response in patients with chronic inflammatory diseases,\nreported today business updates and financial results for the six months ended\nJune 30, 2026. The half-year financial statements, approved by the Company’s\nBoard of Directors on September 18, 2026, have been reviewed by the\nCompany’s statutory auditors, and the financial reports will be filed with\nthe French and U.S. securities regulatory authorities on September 21, 2026. A\nbrief presentation summarizing these business and financial updates is\navailable on the Investor Relations section of Abivax’s website.\n\nStrengthening Leadership Team Ahead of Potential Commercialization\n\nFabio Cataldi, M.D., Chief Medical Officer, will be leaving Abivax in the\nfourth quarter of 2026. Chris Rabbat, Ph.D., who has led Global Medical\nAffairs since 2023, will succeed Dr. Cataldi as Chief Medical Officer, leading\nthe medical organization as Abivax advances toward potential\ncommercialization. Dr. Rabbat brings extensive biopharmaceutical industry\nexperience, including deep expertise in Inflammatory Bowel Disease (“IBD”)\nand experience supporting therapies through commercialization and launch. His\ncombination of industry experience, therapeutic area expertise and\ncommercial-stage medical leadership will be particularly valuable as Abivax\nprepares for the potential commercialization of obefazimod. Abivax thanks Dr.\nCataldi for his important contributions to the Company, including his\nleadership through the late-stage development of obefazimod and advancement of\nthe program toward its planned NDA submission.\n\nAbivax has also appointed Tim Kelly as Chief Technical Officer. Mr. Kelly will\nlead the Company’s commercial CMC, Quality and Information Technology\nfunctions, further strengthening the infrastructure supporting Abivax’s\ncontinued growth and potential transition to a commercial-stage organization.\nMost recently, he served as Chief Technology Officer of Caribou Biosciences\nand previously was the CEO of Oxford Biomedica Solutions. He also held senior\nleadership roles at Homology Medicines, Shire, UCB Pharma and Biogen.\n\nBoth executive appointments are effective immediately.\n\n“As we prepare Abivax for its next phase of growth and the potential\ncommercialization of obefazimod, we are continuing to strengthen the\nleadership and capabilities needed to support that evolution,” said Marc de\nGaridel, MBA, Chief Executive Officer of Abivax. “We are deeply grateful to\nFabio for his important contributions to Abivax and his leadership as we\nadvanced obefazimod through late-stage development toward regulatory filing.\nChris brings extensive experience in IBD and deep relationships with key\nopinion leaders, which will be critical as he leads our medical organization\nthrough the pre-commercial phase and toward potential commercialization. Tim\nbrings extensive commercial supply, technical and operational experience that\nwill further strengthen our CMC, Quality and IT capabilities as we prepare for\npotential commercialization.”\n\nAbivax provided the following key updates on its business and operational\ngoals in press releases published:\n* On May 22, 2026, a press release titled “Abivax Presents First Quarter\n2026 Financial Results and Reports Three-Year Interim Data from Study 108, a\nPhase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose\nDe-Escalation in Patients with Ulcerative Colitis”\n\n\n* On June 1, 2026, a press release titled “Abivax Announces Landmark Phase 3\nABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to\nSeverely Active Ulcerative Colitis”\n\n\n* On June 29, 2026, a press release titled “Abivax Reports Positive ABTECT\nMaintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical\nBenefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase\n3 Maintenance Safety Database”\n\n\n* On July 6, 2026, Abivax completed its underwritten public offering of\n7,360,000 American Depositary Shares, each representing one ordinary share,\nEUR 0.01 nominal value per share, of the Company, in the United States. The\naggregate gross proceeds amounted to approximately $920 million, equivalent to\napproximately €807.4 million, before deduction of underwriting commissions\nand offering expenses, and the net proceeds, after deducting underwriting\ncommissions and offering expenses, were approximately $874.1 million,\nequivalent to approximately €767.1 million.\n\n\n* On July 23, 2026, a press release titled “Abivax Strengthens Commercial\nCapabilities With Strategic Leadership Appointments”\n* On July 30, 2026, a press release titled “Abivax Announces Positive\nPre-NDA Interaction with the FDA for Obefazimod”\nFirst Half 2026 Financial Highlights\n* Royalty Certificate Repurchase: On May 7, 2026, the Company completed the\nrepurchase and cancellation of all outstanding royalty certificates for total\nconsideration of $90 million (approximately €76.5 million), comprising $45\nmillion in cash and $45 million in equity through the issuance of 403,347\nordinary shares represented by ADSs. The transaction resulted in an expense of\napproximately €43.2 million in the second quarter of 2026 and the\nderecognition of a €5.8 million deferred tax liability, with a corresponding\ntax benefit recognized for the six months ended June 30, 2026.\n\n\n* Cash Position and Runway: The Company had cash, cash equivalents and\nshort-term investments of €402.4 million as of June 30, 2026, which,\ntogether with €767.1 million in net proceeds from the early July 2026 public\noffering, provides a projected cash runway into Q4 2029 based on current\noperating assumptions.\n\n\n* R&D Expenses: Research and development (“R&D”) expenses increased by\n€29.9 million to €107.9 million (75.5% of operating expenses) in the first\nhalf of 2026 compared to €77.9 million (81.3% of operating expenses) in the\nfirst half of 2025. This increase was predominantly driven by:\n\n * A €6.8 million increase related to new indications (including combination\ntherapy) for obefazimod;\n* A €4.6 million increase in transversal activities related to increased\nchemistry, manufacturing and controls and supply chain costs related to the\nprogression of clinical trials and anticipation of potential future commercial\nlaunch;\n* A €6.3 million increase related to the Company’s Crohn’s disease\n(“CD”) clinical program, driven by the progression of Phase 2b clinical\ntrials for obefazimod in CD; and\n* A €8.5 million increase related to the Company’s ulcerative colitis\n(“UC”) clinical program, driven by allocation of share-based compensation\nfor grants awarded in 2025, partially offset by a decline in ABTECT clinical\nprogram costs as a result of 2025 milestone payments that did not occur in\n2026.\n\n\n \n* G&A Expenses: General and administrative expenses increased by €14.1\nmillion to €30.4 million (21.3% of operating expenses) in the first half of\n2026 compared to €16.3 million (17.0% of operating expenses) in the first\nhalf of 2025. This increase is primarily due to an increase of €8.6 million\nin personnel costs, primarily attributable to an increase in share-based\ncompensation expense related to the impact of share-based awards granted in\n2025 and their associated tax and social contributions of €6.1 million. The\nincrease was also due to a €4.5 million increase in consulting and\nprofessional fees, driven by costs associated with building the Company’s\ninfrastructure to support future growth in its operations. \n\n\n* Sales and Marketing Expenses: Sales and marketing expenses increased by\n€3.1 million to €4.6 million (3.2% of operating expenses) in the first\nhalf of 2026 compared to €1.5 million (1.6% of operating expenses) in the\nfirst half of 2025. The increase was driven by costs related to the\nCompany’s continued preparation for potential future sales and\ncommercialization efforts for obefazimod in the U.S. which are expected to\ncontinue to accelerate in preparation for commercial launch.\nAnticipated Upcoming Key Dates\n* October 2026 – Participation at United European Gastroenterology Week\n(UEGW)\n* End of 2026 – Planned NDA submission for obefazimod in UC\n* Mid-2027 – Topline results from the Phase 2b ENHANCE-CD induction trial\nevaluating obefazimod in CD\nFirst Half 2026 Financial Results (IFRS figures)\n\n Statement of Cash Flows                                   For the six months ended June 30,           \n in millions of euros                                      2025                        2026            \n Cash flows provided by (used in) operating activities     (66.6)                      (102.5)         \n Cash flows provided by (used in) investing activities     1.3                         1.5             \n Cash flows provided by (used in) financing activities     (16.6)                      (39.3)          \n                                                                                                       \n Effect of movements in exchange rates on cash held        (1.8)                       6.2             \n Revaluation of cash equivalents measured at fair value    0.5                         5.4             \n                                                                                                       \n Increase (decrease) in cash and cash equivalents          (83.3)                      (128.7)         \n\n\n\n Statement of Income (Loss)                   For the six months ended June 30,           \n in millions of euros                         2025                        2026            \n Total operating income                       2.1                         2.5             \n Total operating expenses                                                                 \n of which Research and Development costs      (77.9)                      (107.9)         \n of which Sales and Marketing costs           (1.5)                       (4.6)           \n of which General and Administrative costs    (16.3)                      (30.4)          \n Operating loss                               (93.7)                      (140.3)         \n                                                                                          \n Financial gain (loss)                        (7.1)                       (31.4)          \n                                                                                          \n Net loss before tax                          (100.8)                     (171.7)         \n                                                                                          \n Income tax                                   —                           5.8             \n                                                                                          \n Net loss for the period                      (100.8)                     (165.9)         \n\n\n\n Statement of Financial Position                     As of                                   \n in millions of euros                                December 31, 2025      June 30, 2026    \n                                                                                             \n Non-current assets                                  33.1                   34.6             \n                                                                                             \n Cash and cash equivalents                           516.7                  388.0            \n Other current assets (1)                            34.6                   39.6             \n Total Assets                                        584.3                  462.2            \n                                                                                             \n Borrowings, notes and derivative instruments (2)    1.9                    1.2              \n Royalty Certificates                                30.2                   —                \n Other non-current liabilities                       35.3                   24.1             \n Other current liabilities                           61.7                   70.6             \n Total Liabilities                                   129.1                  95.9             \n                                                                                             \n Total Shareholders’ Equity                          455.2                  366.3            \n                                                                                             \n Total Liabilities and Shareholders’ Equity          584.3                  462.2            \n\n(1) Includes certain short-term investments (terms of less than 12 months) of\n€14.4M, making total cash, cash equivalents and short-term investments of\n€402.4 million\n(2 )Includes both current and non-current portions of borrowings, convertible\nloan notes, derivative instruments, and lease liabilities\n\n*****\n\nAbout Abivax \nAbivax is a clinical-stage biotechnology company focused on developing\ntherapeutics that harness the body’s natural regulatory mechanisms to\nstabilize the immune response in patients with chronic inflammatory diseases.\nBased in France and the United States, Abivax’s lead drug candidate,\nobefazimod (ABX464), is in Phase 3 clinical trials for the treatment of\nmoderately to severely active ulcerative colitis.\n\nContacts:\nPatrick Malloy\nSVP, Investor Relations\nAbivax SA\npatrick.malloy@abivax.com    \n+1 847 987 4878\n\nMedia Contacts:\nLifeSci Communications\nKarissa Cross, PhD\nAssociate Director\nLSC_ABIVAX@lifescicomms.com\n\nFORWARD-LOOKING STATEMENTS\n\nThis press release contains forward-looking statements, forecasts and\nestimates, including those relating to the Company’s business. Words such as\n“anticipate,” “expect,” “future,” “potential,” “will” and\nvariations of such words and similar expressions are intended to identify\nforward-looking statements. These forward-looking statements include\nstatements concerning the potential therapeutic benefit of obefazimod, the\nexpected timing for completion of the Phase 2b ENHANCE-CD induction trial of\nobefazimod and the availability and timing of results therefrom, the timing of\nregulatory filings including an NDA submission for obefazimod in UC,\nAbivax’s expectations for regulatory approval and commercialization of\nobefazimod for UC, the expected increase in costs associated with preparing\nfor commercial launch of obefazimod, including the anticipated PDUFA date,\nAbivax’s cash runway, and other statements that are not historical fact.\nAlthough Abivax’s management believes that the expectations reflected in\nsuch forward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks,\ncontingencies and uncertainties, many of which are difficult to predict and\ngenerally beyond the control of Abivax, that could cause actual results and\ndevelopments to differ materially from those expressed in, or implied or\nprojected by, the forward-looking information and statements. A description of\nthese risks, contingencies and uncertainties can be found in the documents\nfiled by the Company with the French Autorité des Marchés Financiers\npursuant to its legal obligations including its universal registration\ndocument (Document d’Enregistrement Universel) and in its Annual Report on\nForm 20-F for the fiscal year ended December 31, 2025 filed with the U.S.\nSecurities and Exchange Commission on March 23, 2026, under the caption\n“Risk Factors.” These risks, contingencies and uncertainties include,\namong other things, the uncertainties inherent in research and development,\nfuture clinical data and analysis, decisions by regulatory authorities, such\nas the FDA or the EMA, regarding whether and when to approve any drug\ncandidate, as well as their decisions regarding labelling and other matters\nthat could affect the availability or commercial potential of such product\ncandidates, and the availability of funding sufficient for the Company’s\nforeseeable and unforeseeable operating expenses and capital expenditure\nrequirements. Special consideration should be given to the potential hurdles\nof clinical and pharmaceutical development, including further assessment by\nthe Company and regulatory agencies and IRBs/ethics committees following the\nassessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and\nclinical data. Furthermore, these forward-looking statements, forecasts and\nestimates are made only as of the date of this press release. Readers are\ncautioned not to place undue reliance on these forward-looking statements.\nAbivax disclaims any obligation to update these forward-looking statements,\nforecasts or estimates to reflect any subsequent changes that the Company\nbecomes aware of, except as required by law. Information about pharmaceutical\nproducts (including products currently in development) that is included in\nthis press release is not intended to constitute an advertisement. This press\nrelease is for information purposes only, and the information contained herein\ndoes not constitute either an offer to sell or the solicitation of an offer to\npurchase or subscribe for securities of the Company in any jurisdiction.\nSimilarly, it does not give and should not be treated as giving investment\nadvice. It has no connection with the investment objectives, financial\nsituation or specific needs of any recipient. It should not be regarded by\nrecipients as a substitute for exercise of their own judgment. All opinions\nexpressed herein are subject to change without notice. The distribution of\nthis document may be restricted by law in certain jurisdictions. Persons into\nwhose possession this document comes are required to inform themselves about\nand to observe any such restrictions.\n\nAttachment\n*     20260921_Abivax_PR_First Half 2026 Financial Results\n(https://ml-eu.globenewswire.com/Resource/Download/74394047-9e03-4606-94bf-bbed5fa29226)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5470cd7e-c1fe-402f-8673-925c82bbd2fb)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8GSJwt-20260921","title":"Abivax Presents Business Updates and First Half 2026 Financial Results ","author":"Globe Newswire","ticker":"ABVX","created":"2026-09-21T20:05:00.424Z","tickers":["ABVX"],"exchange":"Euronext Paris","article_body":"Abivax Presents Business Updates and First Half 2026 Financial Results \n* Chris Rabbat to succeed Fabio Cataldi as Chief Medical Officer; Tim Kelly\nappointed Chief Technical Officer to advance commercial supply readiness and\nlead Abivax’s Chemistry, Manufacturing and Controls (“CMC”), Quality and\nInformation Technology (“IT”) functions\n\n\n* Cash, cash equivalents and short-term investments of €402.4 million as of\nJune 30, 2026, combined with €767.1 million in net proceeds from the early\nJuly underwritten public offering, provides cash runway into Q4 2029\n\n\n* Royalty certificates buy-back completed in Q2 2026 materially reduces\nroyalty overhang, further strengthening Abivax’s debt-free financial\nposition and flexibility to support future commercialization efforts\nPARIS, France – September 21, 2026 – 10:05 PM CEST – Abivax SA\n(https://www.globenewswire.com/Tracker?data=x6zZ2FmIADrE21vAzvJxjHEAZlZ2n5S22c_hexKznbTF3KZIbCB2cjOELkTHfoXOPDmOPSfxBfM4innV1fPC5w==)\n(Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the\n“Company”), a clinical-stage biotechnology company focused on developing\ntherapeutics that harness the body’s natural regulatory mechanisms to\nstabilize the immune response in patients with chronic inflammatory diseases,\nreported today business updates and financial results for the six months ended\nJune 30, 2026. The half-year financial statements, approved by the Company’s\nBoard of Directors on September 18, 2026, have been reviewed by the\nCompany’s statutory auditors, and the financial reports will be filed with\nthe French and U.S. securities regulatory authorities on September 21, 2026. A\nbrief presentation summarizing these business and financial updates is\navailable on the Investor Relations section of Abivax’s website.\n\nStrengthening Leadership Team Ahead of Potential Commercialization\n\nFabio Cataldi, M.D., Chief Medical Officer, will be leaving Abivax in the\nfourth quarter of 2026. Chris Rabbat, Ph.D., who has led Global Medical\nAffairs since 2023, will succeed Dr. Cataldi as Chief Medical Officer, leading\nthe medical organization as Abivax advances toward potential\ncommercialization. Dr. Rabbat brings extensive biopharmaceutical industry\nexperience, including deep expertise in Inflammatory Bowel Disease (“IBD”)\nand experience supporting therapies through commercialization and launch. His\ncombination of industry experience, therapeutic area expertise and\ncommercial-stage medical leadership will be particularly valuable as Abivax\nprepares for the potential commercialization of obefazimod. Abivax thanks Dr.\nCataldi for his important contributions to the Company, including his\nleadership through the late-stage development of obefazimod and advancement of\nthe program toward its planned NDA submission.\n\nAbivax has also appointed Tim Kelly as Chief Technical Officer. Mr. Kelly will\nlead the Company’s commercial CMC, Quality and Information Technology\nfunctions, further strengthening the infrastructure supporting Abivax’s\ncontinued growth and potential transition to a commercial-stage organization.\nMost recently, he served as Chief Technology Officer of Caribou Biosciences\nand previously was the CEO of Oxford Biomedica Solutions. He also held senior\nleadership roles at Homology Medicines, Shire, UCB Pharma and Biogen.\n\nBoth executive appointments are effective immediately.\n\n“As we prepare Abivax for its next phase of growth and the potential\ncommercialization of obefazimod, we are continuing to strengthen the\nleadership and capabilities needed to support that evolution,” said Marc de\nGaridel, MBA, Chief Executive Officer of Abivax. “We are deeply grateful to\nFabio for his important contributions to Abivax and his leadership as we\nadvanced obefazimod through late-stage development toward regulatory filing.\nChris brings extensive experience in IBD and deep relationships with key\nopinion leaders, which will be critical as he leads our medical organization\nthrough the pre-commercial phase and toward potential commercialization. Tim\nbrings extensive commercial supply, technical and operational experience that\nwill further strengthen our CMC, Quality and IT capabilities as we prepare for\npotential commercialization.”\n\nAbivax provided the following key updates on its business and operational\ngoals in press releases published:\n* On May 22, 2026, a press release titled “Abivax Presents First Quarter\n2026 Financial Results and Reports Three-Year Interim Data from Study 108, a\nPhase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose\nDe-Escalation in Patients with Ulcerative Colitis”\n\n\n* On June 1, 2026, a press release titled “Abivax Announces Landmark Phase 3\nABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to\nSeverely Active Ulcerative Colitis”\n\n\n* On June 29, 2026, a press release titled “Abivax Reports Positive ABTECT\nMaintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical\nBenefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase\n3 Maintenance Safety Database”\n\n\n* On July 6, 2026, Abivax completed its underwritten public offering of\n7,360,000 American Depositary Shares, each representing one ordinary share,\nEUR 0.01 nominal value per share, of the Company, in the United States. The\naggregate gross proceeds amounted to approximately $920 million, equivalent to\napproximately €807.4 million, before deduction of underwriting commissions\nand offering expenses, and the net proceeds, after deducting underwriting\ncommissions and offering expenses, were approximately $874.1 million,\nequivalent to approximately €767.1 million.\n\n\n* On July 23, 2026, a press release titled “Abivax Strengthens Commercial\nCapabilities With Strategic Leadership Appointments”\n* On July 30, 2026, a press release titled “Abivax Announces Positive\nPre-NDA Interaction with the FDA for Obefazimod”\nFirst Half 2026 Financial Highlights\n* Royalty Certificate Repurchase: On May 7, 2026, the Company completed the\nrepurchase and cancellation of all outstanding royalty certificates for total\nconsideration of $90 million (approximately €76.5 million), comprising $45\nmillion in cash and $45 million in equity through the issuance of 403,347\nordinary shares represented by ADSs. The transaction resulted in an expense of\napproximately €43.2 million in the second quarter of 2026 and the\nderecognition of a €5.8 million deferred tax liability, with a corresponding\ntax benefit recognized for the six months ended June 30, 2026.\n\n\n* Cash Position and Runway: The Company had cash, cash equivalents and\nshort-term investments of €402.4 million as of June 30, 2026, which,\ntogether with €767.1 million in net proceeds from the early July 2026 public\noffering, provides a projected cash runway into Q4 2029 based on current\noperating assumptions.\n\n\n* R&D Expenses: Research and development (“R&D”) expenses increased by\n€29.9 million to €107.9 million (75.5% of operating expenses) in the first\nhalf of 2026 compared to €77.9 million (81.3% of operating expenses) in the\nfirst half of 2025. This increase was predominantly driven by:\n\n * A €6.8 million increase related to new indications (including combination\ntherapy) for obefazimod;\n* A €4.6 million increase in transversal activities related to increased\nchemistry, manufacturing and controls and supply chain costs related to the\nprogression of clinical trials and anticipation of potential future commercial\nlaunch;\n* A €6.3 million increase related to the Company’s Crohn’s disease\n(“CD”) clinical program, driven by the progression of Phase 2b clinical\ntrials for obefazimod in CD; and\n* A €8.5 million increase related to the Company’s ulcerative colitis\n(“UC”) clinical program, driven by allocation of share-based compensation\nfor grants awarded in 2025, partially offset by a decline in ABTECT clinical\nprogram costs as a result of 2025 milestone payments that did not occur in\n2026.\n\n\n \n* G&A Expenses: General and administrative expenses increased by €14.1\nmillion to €30.4 million (21.3% of operating expenses) in the first half of\n2026 compared to €16.3 million (17.0% of operating expenses) in the first\nhalf of 2025. This increase is primarily due to an increase of €8.6 million\nin personnel costs, primarily attributable to an increase in share-based\ncompensation expense related to the impact of share-based awards granted in\n2025 and their associated tax and social contributions of €6.1 million. The\nincrease was also due to a €4.5 million increase in consulting and\nprofessional fees, driven by costs associated with building the Company’s\ninfrastructure to support future growth in its operations. \n\n\n* Sales and Marketing Expenses: Sales and marketing expenses increased by\n€3.1 million to €4.6 million (3.2% of operating expenses) in the first\nhalf of 2026 compared to €1.5 million (1.6% of operating expenses) in the\nfirst half of 2025. The increase was driven by costs related to the\nCompany’s continued preparation for potential future sales and\ncommercialization efforts for obefazimod in the U.S. which are expected to\ncontinue to accelerate in preparation for commercial launch.\nAnticipated Upcoming Key Dates\n* October 2026 – Participation at United European Gastroenterology Week\n(UEGW)\n* End of 2026 – Planned NDA submission for obefazimod in UC\n* Mid-2027 – Topline results from the Phase 2b ENHANCE-CD induction trial\nevaluating obefazimod in CD\nFirst Half 2026 Financial Results (IFRS figures)\n\n Statement of Cash Flows                                   For the six months ended June 30,           \n in millions of euros                                      2025                        2026            \n Cash flows provided by (used in) operating activities     (66.6)                      (102.5)         \n Cash flows provided by (used in) investing activities     1.3                         1.5             \n Cash flows provided by (used in) financing activities     (16.6)                      (39.3)          \n                                                                                                       \n Effect of movements in exchange rates on cash held        (1.8)                       6.2             \n Revaluation of cash equivalents measured at fair value    0.5                         5.4             \n                                                                                                       \n Increase (decrease) in cash and cash equivalents          (83.3)                      (128.7)         \n\n\n\n Statement of Income (Loss)                   For the six months ended June 30,           \n in millions of euros                         2025                        2026            \n Total operating income                       2.1                         2.5             \n Total operating expenses                                                                 \n of which Research and Development costs      (77.9)                      (107.9)         \n of which Sales and Marketing costs           (1.5)                       (4.6)           \n of which General and Administrative costs    (16.3)                      (30.4)          \n Operating loss                               (93.7)                      (140.3)         \n                                                                                          \n Financial gain (loss)                        (7.1)                       (31.4)          \n                                                                                          \n Net loss before tax                          (100.8)                     (171.7)         \n                                                                                          \n Income tax                                   —                           5.8             \n                                                                                          \n Net loss for the period                      (100.8)                     (165.9)         \n\n\n\n Statement of Financial Position                     As of                                   \n in millions of euros                                December 31, 2025      June 30, 2026    \n                                                                                             \n Non-current assets                                  33.1                   34.6             \n                                                                                             \n Cash and cash equivalents                           516.7                  388.0            \n Other current assets (1)                            34.6                   39.6             \n Total Assets                                        584.3                  462.2            \n                                                                                             \n Borrowings, notes and derivative instruments (2)    1.9                    1.2              \n Royalty Certificates                                30.2                   —                \n Other non-current liabilities                       35.3                   24.1             \n Other current liabilities                           61.7                   70.6             \n Total Liabilities                                   129.1                  95.9             \n                                                                                             \n Total Shareholders’ Equity                          455.2                  366.3            \n                                                                                             \n Total Liabilities and Shareholders’ Equity          584.3                  462.2            \n\n(1) Includes certain short-term investments (terms of less than 12 months) of\n€14.4M, making total cash, cash equivalents and short-term investments of\n€402.4 million\n(2 )Includes both current and non-current portions of borrowings, convertible\nloan notes, derivative instruments, and lease liabilities\n\n*****\n\nAbout Abivax \nAbivax is a clinical-stage biotechnology company focused on developing\ntherapeutics that harness the body’s natural regulatory mechanisms to\nstabilize the immune response in patients with chronic inflammatory diseases.\nBased in France and the United States, Abivax’s lead drug candidate,\nobefazimod (ABX464), is in Phase 3 clinical trials for the treatment of\nmoderately to severely active ulcerative colitis.\n\nContacts:\nPatrick Malloy\nSVP, Investor Relations\nAbivax SA\npatrick.malloy@abivax.com    \n+1 847 987 4878\n\nMedia Contacts:\nLifeSci Communications\nKarissa Cross, PhD\nAssociate Director\nLSC_ABIVAX@lifescicomms.com\n\nFORWARD-LOOKING STATEMENTS\n\nThis press release contains forward-looking statements, forecasts and\nestimates, including those relating to the Company’s business. Words such as\n“anticipate,” “expect,” “future,” “potential,” “will” and\nvariations of such words and similar expressions are intended to identify\nforward-looking statements. These forward-looking statements include\nstatements concerning the potential therapeutic benefit of obefazimod, the\nexpected timing for completion of the Phase 2b ENHANCE-CD induction trial of\nobefazimod and the availability and timing of results therefrom, the timing of\nregulatory filings including an NDA submission for obefazimod in UC,\nAbivax’s expectations for regulatory approval and commercialization of\nobefazimod for UC, the expected increase in costs associated with preparing\nfor commercial launch of obefazimod, including the anticipated PDUFA date,\nAbivax’s cash runway, and other statements that are not historical fact.\nAlthough Abivax’s management believes that the expectations reflected in\nsuch forward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks,\ncontingencies and uncertainties, many of which are difficult to predict and\ngenerally beyond the control of Abivax, that could cause actual results and\ndevelopments to differ materially from those expressed in, or implied or\nprojected by, the forward-looking information and statements. A description of\nthese risks, contingencies and uncertainties can be found in the documents\nfiled by the Company with the French Autorité des Marchés Financiers\npursuant to its legal obligations including its universal registration\ndocument (Document d’Enregistrement Universel) and in its Annual Report on\nForm 20-F for the fiscal year ended December 31, 2025 filed with the U.S.\nSecurities and Exchange Commission on March 23, 2026, under the caption\n“Risk Factors.” These risks, contingencies and uncertainties include,\namong other things, the uncertainties inherent in research and development,\nfuture clinical data and analysis, decisions by regulatory authorities, such\nas the FDA or the EMA, regarding whether and when to approve any drug\ncandidate, as well as their decisions regarding labelling and other matters\nthat could affect the availability or commercial potential of such product\ncandidates, and the availability of funding sufficient for the Company’s\nforeseeable and unforeseeable operating expenses and capital expenditure\nrequirements. Special consideration should be given to the potential hurdles\nof clinical and pharmaceutical development, including further assessment by\nthe Company and regulatory agencies and IRBs/ethics committees following the\nassessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and\nclinical data. Furthermore, these forward-looking statements, forecasts and\nestimates are made only as of the date of this press release. Readers are\ncautioned not to place undue reliance on these forward-looking statements.\nAbivax disclaims any obligation to update these forward-looking statements,\nforecasts or estimates to reflect any subsequent changes that the Company\nbecomes aware of, except as required by law. Information about pharmaceutical\nproducts (including products currently in development) that is included in\nthis press release is not intended to constitute an advertisement. This press\nrelease is for information purposes only, and the information contained herein\ndoes not constitute either an offer to sell or the solicitation of an offer to\npurchase or subscribe for securities of the Company in any jurisdiction.\nSimilarly, it does not give and should not be treated as giving investment\nadvice. It has no connection with the investment objectives, financial\nsituation or specific needs of any recipient. It should not be regarded by\nrecipients as a substitute for exercise of their own judgment. All opinions\nexpressed herein are subject to change without notice. The distribution of\nthis document may be restricted by law in certain jurisdictions. Persons into\nwhose possession this document comes are required to inform themselves about\nand to observe any such restrictions.\n\nAttachment\n*     20260921_Abivax_PR_First Half 2026 Financial Results\n(https://ml-eu.globenewswire.com/Resource/Download/74394047-9e03-4606-94bf-bbed5fa29226)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5470cd7e-c1fe-402f-8673-925c82bbd2fb)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-21T20:05:00.471341295Z","server_sent_at_ms":1790021100471},"received_at":"2026-09-21T20:05:00.528Z","source_url":"https://www.globenewswire.com/news-release/2026/09/21/3365853/0/en/abivax-presents-business-updates-and-first-half-2026-financial-results.html"},"analysis":{"id":"137475","press_release_id":"148906","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["CMO Fabio Cataldi departing in Q4 2026, shortly before the planned end-of-2026 NDA submission for obefazimod (internal successor Chris Rabbat named, which mitigates)","Net loss widened to €165.9M from €100.8M and operating cash outflow grew to €102.5M from €66.6M, implying an accelerating burn rate","Financial loss of €31.4M (vs €7.1M prior year) deepened the pre-tax loss","Heavy recent dilution: July 2026 offering of 7.36M ADSs raised ~$920M gross, and the royalty buyback settled a further $45M in equity (403,347 ADSs)"],"eventType":"earnings","narrative":"Abivax reported first half 2026 results with €402.4 million in cash, cash equivalents and short-term investments at June 30, 2026, which combined with €767.1 million in net proceeds from the early-July underwritten offering provides a cash runway into Q4 2029.\n\nChris Rabbat will succeed Fabio Cataldi as Chief Medical Officer when Cataldi departs in Q4 2026, and Tim Kelly joins as Chief Technical Officer to lead commercial CMC, Quality and IT ahead of potential obefazimod commercialization.\n\nThe half-year net loss widened to €165.9 million from €100.8 million as R&D spending rose €29.9 million to €107.9 million, ahead of a planned NDA submission for obefazimod in ulcerative colitis by end of 2026.\n\nAbivax completed a $90 million repurchase of all outstanding royalty certificates in Q2 2026 ($45 million cash, $45 million equity), removing the royalty overhang while keeping the balance sheet debt-free.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Runway into Q4 2029 plus a leadership build-out signal Abivax is staffing for launch ahead of a year-end NDA submission for obefazimod."},"keyFigures":{"drugName":"obefazimod (ABX464)","phaseOfTrial":"Phase 3 (ulcerative colitis ABTECT); Phase 2b ENHANCE-CD (Crohn's disease)","sharesOffered":7360000,"customDimensions":{"cash_runway":"into Q4 2029","cash_position_eur_m":402.4,"nda_submission_timing":"end of 2026 (obefazimod in UC)","enhance_cd_topline_timing":"mid-2027","ga_expenses_h1_2026_eur_m":30.4,"rd_expenses_h1_2026_eur_m":107.9,"offering_net_proceeds_eur_m":767.1,"offering_net_proceeds_usd_m":874.1,"total_operating_income_eur_m":2.5,"offering_gross_proceeds_usd_m":920,"rd_expense_yoy_increase_eur_m":29.9,"royalty_repurchase_shares_issued":403347,"royalty_repurchase_cash_portion_usd_m":45,"sales_marketing_expenses_h1_2026_eur_m":4.6,"royalty_repurchase_equity_portion_usd_m":45,"royalty_certificate_repurchase_total_usd_m":90}},"quotedText":"As we prepare Abivax for its next phase of growth and the potential\ncommercialization of obefazimod, we are continuing to strengthen the\nleadership and capabilities needed to support that evolution","namedEntities":{"people":[{"name":"Fabio Cataldi, M.D.","role":"Chief Medical Officer, departing in Q4 2026"},{"name":"Chris Rabbat, Ph.D.","role":"incoming Chief Medical Officer (has led Global Medical Affairs since 2023)"},{"name":"Tim Kelly","role":"appointed Chief Technical Officer"},{"name":"Marc de Garidel, MBA","role":"Chief Executive Officer"},{"name":"Patrick Malloy","role":"SVP, Investor Relations"}],"products":["obefazimod (ABX464)"],"companies":[{"name":"Abivax SA","ticker":"ABVX","relationship":"filer / issuer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator (positive pre-NDA interaction; NDA submission planned end of 2026)"},{"name":"Caribou Biosciences","relationship":"Tim Kelly's most recent employer (Chief Technology Officer)"},{"name":"Oxford Biomedica Solutions","relationship":"Tim Kelly's prior employer (CEO)"},{"name":"Homology Medicines","relationship":"Tim Kelly's prior employer"},{"name":"Shire","relationship":"Tim Kelly's prior employer"},{"name":"UCB Pharma","relationship":"Tim Kelly's prior employer"},{"name":"Biogen","relationship":"Tim Kelly's prior employer"}],"dollarAmounts":[{"amount":"$920 million","context":"approximate gross proceeds of July 2026 underwritten public offering (7,360,000 ADSs)"},{"amount":"$874.1 million","context":"approximate net proceeds of July 2026 public offering"},{"amount":"€807.4 million","context":"EUR equivalent of gross proceeds of July 2026 offering"},{"amount":"€767.1 million","context":"EUR equivalent of net proceeds of July 2026 offering"},{"amount":"€402.4 million","context":"cash, cash equivalents and short-term investments as of June 30, 2026"},{"amount":"$90 million","context":"total consideration for repurchase and cancellation of all outstanding royalty certificates (approximately €76.5 million)"},{"amount":"$45 million","context":"cash portion of royalty certificate repurchase"},{"amount":"$45 million","context":"equity portion of royalty certificate repurchase (403,347 ordinary shares represented by ADSs)"}]},"materialImpact":{"score":3,"reasoning":"Scheduled half-year report, but substantive: confirms pro forma cash of ~€1.17B (€402.4M plus €767.1M July offering net proceeds) extending runway into Q4 2029, announces CMO succession and a new CTO ahead of a year-end NDA submission, and closes out a $90M royalty certificate repurchase. No surprise, binary event, or new clinical data, so below the 4-5 threshold."},"tickerRelevance":{"others":[],"primary":"ABVX"},"globalImportance":32,"audienceRelevance":35,"eventTypeSecondary":["executive_change"],"importanceComponents":{"tickerTier":"mid-cap clinical-stage biotech (Nasdaq/Euronext dual-listed)","eventGravity":"scheduled half-year results + C-suite changes + runway confirmation","sectorWeight":"biotech - cash runway is the key metric pre-NDA","issuerAuthored":true,"newClinicalData":false,"retailFavoriteBoost":"moderate - high-profile Phase 3 program and $920M raise drive retail following"}},"event_type":"earnings","event_type_secondary":["executive_change"],"sentiment":"bullish","material_impact_score":3,"narrative":"Abivax reported first half 2026 results with €402.4 million in cash, cash equivalents and short-term investments at June 30, 2026, which combined with €767.1 million in net proceeds from the early-July underwritten offering provides a cash runway into Q4 2029.\n\nChris Rabbat will succeed Fabio Cataldi as Chief Medical Officer when Cataldi departs in Q4 2026, and Tim Kelly joins as Chief Technical Officer to lead commercial CMC, Quality and IT ahead of potential obefazimod commercialization.\n\nThe half-year net loss widened to €165.9 million from €100.8 million as R&D spending rose €29.9 million to €107.9 million, ahead of a planned NDA submission for obefazimod in ulcerative colitis by end of 2026.\n\nAbivax completed a $90 million repurchase of all outstanding royalty certificates in Q2 2026 ($45 million cash, $45 million equity), removing the royalty overhang while keeping the balance sheet debt-free.","key_figures":{"drugName":"obefazimod (ABX464)","phaseOfTrial":"Phase 3 (ulcerative colitis ABTECT); Phase 2b ENHANCE-CD (Crohn's disease)","sharesOffered":7360000,"customDimensions":{"cash_runway":"into Q4 2029","cash_position_eur_m":402.4,"nda_submission_timing":"end of 2026 (obefazimod in UC)","enhance_cd_topline_timing":"mid-2027","ga_expenses_h1_2026_eur_m":30.4,"rd_expenses_h1_2026_eur_m":107.9,"offering_net_proceeds_eur_m":767.1,"offering_net_proceeds_usd_m":874.1,"total_operating_income_eur_m":2.5,"offering_gross_proceeds_usd_m":920,"rd_expense_yoy_increase_eur_m":29.9,"royalty_repurchase_shares_issued":403347,"royalty_repurchase_cash_portion_usd_m":45,"sales_marketing_expenses_h1_2026_eur_m":4.6,"royalty_repurchase_equity_portion_usd_m":45,"royalty_certificate_repurchase_total_usd_m":90}},"named_entities":{"people":[{"name":"Fabio Cataldi, M.D.","role":"Chief Medical Officer, departing in Q4 2026"},{"name":"Chris Rabbat, Ph.D.","role":"incoming Chief Medical Officer (has led Global Medical Affairs since 2023)"},{"name":"Tim Kelly","role":"appointed Chief Technical Officer"},{"name":"Marc de Garidel, MBA","role":"Chief Executive Officer"},{"name":"Patrick Malloy","role":"SVP, Investor Relations"}],"products":["obefazimod (ABX464)"],"companies":[{"name":"Abivax SA","ticker":"ABVX","relationship":"filer / issuer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator (positive pre-NDA interaction; NDA submission planned end of 2026)"},{"name":"Caribou Biosciences","relationship":"Tim Kelly's most recent employer (Chief Technology Officer)"},{"name":"Oxford Biomedica Solutions","relationship":"Tim Kelly's prior employer (CEO)"},{"name":"Homology Medicines","relationship":"Tim Kelly's prior employer"},{"name":"Shire","relationship":"Tim Kelly's prior employer"},{"name":"UCB Pharma","relationship":"Tim Kelly's prior employer"},{"name":"Biogen","relationship":"Tim Kelly's prior employer"}],"dollarAmounts":[{"amount":"$920 million","context":"approximate gross proceeds of July 2026 underwritten public offering (7,360,000 ADSs)"},{"amount":"$874.1 million","context":"approximate net proceeds of July 2026 public offering"},{"amount":"€807.4 million","context":"EUR equivalent of gross proceeds of July 2026 offering"},{"amount":"€767.1 million","context":"EUR equivalent of net proceeds of July 2026 offering"},{"amount":"€402.4 million","context":"cash, cash equivalents and short-term investments as of June 30, 2026"},{"amount":"$90 million","context":"total consideration for repurchase and cancellation of all outstanding royalty certificates (approximately €76.5 million)"},{"amount":"$45 million","context":"cash portion of royalty certificate repurchase"},{"amount":"$45 million","context":"equity portion of royalty certificate repurchase (403,347 ordinary shares represented by ADSs)"}]},"model_name":"glm-5.3-flash","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-21T20:12:51.856Z","global_importance":32,"audience_relevance":35,"importance_components":{"tickerTier":"mid-cap clinical-stage biotech (Nasdaq/Euronext dual-listed)","eventGravity":"scheduled half-year results + C-suite changes + runway confirmation","sectorWeight":"biotech - cash runway is the key metric pre-NDA","issuerAuthored":true,"newClinicalData":false,"retailFavoriteBoost":"moderate - high-profile Phase 3 program and $920M raise drive retail following"}},"durationMs":471320,"modelName":"glm-5.3-flash"}}