{"success":true,"data":{"pressRelease":{"id":"155778","rtpr_id":"nBw4DdRs7a-20260929","ticker":"MAAT","exchange":"Euronext Paris","all_tickers":["MAAT"],"title":"MaaT Pharma Publishes its Half-Year 2026 Results and Provides a Business Update","author":"Business Wire","published_at":"2026-09-29T16:00:00.226Z","article_body":"MaaT Pharma Publishes its Half-Year 2026 Results and Provides a Business\nUpdate\n\n\n * MaaT013 (Xervyteg(®)):\n\n\n* In September 2026, following the re-examination procedure, the CHMP\nmaintained\nits negative opinion on the Conditional Marketing Authorization Application\n(MAA) for MaaT013 (Xervyteg(®)).\n\n * Feedback received through a Type C interaction with the U.S. Food and Drug\nAdministration (FDA) contributes to the preparation of PHOENIX as a proposed\nregistrational Phase 3 trial and provides a framework for finalizing the\nprotocol and progressing U.S. development activities.\n\n\n\n\n * MaaT034: CMC-focused pre-Investigational New Drug (IND) meeting with the U.S.\nFDA, focused on CMC (Chemistry, Manufacturing and Controls) activities,\nscheduled for October 2026.\n\n * Revenue of €1.1 million in H1 2026, compared with €2.4 million in H1 2025,\nmostly driven by the impact of the Clinigen Licensing Agreement as of January\n1, 2026, while patient demand in the Early Access Program (EAP) remained\nglobally stable.\n\n * Cash and cash equivalents of €17.1 million as of June 30, 2026.\n\n * Cash runway now estimated to extend to December 2026 based on the Company’s\ncurrent operating plan.\n\n * The Company is exploring financing opportunities from investors and strategic\npartnerships\n\nRegulatory News:\n\nMaaT Pharma\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=MaaT+Pharma&index=1&md5=0db279468343f883fb4a4711f9caf511)\n(EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company\nand a leader in the development of Microbiome Ecosystem Therapies(TM )(MET)\ndedicated to enhancing survival for patients with cancer through immune\nmodulation, today announced its half-year financial results for the six-month\nperiod ended June 30, 2026, and provided a business update.\n\n“In the first half of 2026, the Company continued to advance its development\npipeline.\n\nFollowing the negative CHMP opinion on MaaT013 (Xervyteg(®)), we initiated a\ncomprehensive review of our portfolio and operating priorities. The measures\nimplemented extend, based on our current estimates, our cash runway to\nDecember 2026, while we continue to actively explore financing and strategic\npartnership opportunities to support the Company’s priority programs”\nstated Eric Soyer, CFO of MaaT Pharma.\n\nPipeline highlights\n\nIn Hemato-Oncology\n\nAcute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg(®))\n\n\n * In January 2026, MaaT Pharma transitioned the Early Access Program in Europe\nto Clinigen. As of June 30, 2026 and since 2019, more than 550 authorizations\nhave been given under the Early Access Program in 14 different countries.\n\n * In \nMarch 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fmarch-9-2026-maat-pharma-to-present-four-abstracts-at-the-52nd-european-bone-marrow-transplantation-annual-meeting-and-to-highlight-clinigen-hosted-industry-symposium-on-acute-gvhd-management%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=March+2026&index=2&md5=ed5223e1a080e1b819fd68fafdd5618f)\n\n, at the European Society for Blood and Marrow Transplantation (EBMT) 2026\nAnnual Meeting, MaaT Pharma presented final results from the ARES trial\nevaluating MaaT013 (Xervyteg(®)) in aGvHD. The Company also presented CHRONOS\nreal-world data, reporting 29% 12-month overall survival and 37% Day-28 GI-ORR\nin third-line patients treated with therapies other than microbiome-based\ntreatments. Clinigen hosted a dedicated symposium on steroid-refractory\nGI-aGvHD.\n\n * In \nApril 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fapril-1st-2026-maat-pharma-announces-publication-of-retrospective-data-in-third-line-acute-gvhd-from-the-chronos-study-in-bone-marrow-transplantation-journal-2%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=April+2026&index=3&md5=bb963b063fa48fcdfb695163cdf61bd3)\n\n, the CHRONOS study was published in Bone Marrow Transplantation, a\npeer-reviewed journal.\n\n * MaaT013 (Xervyteg(®)) Regulatory Evaluation:\n\nIn Europe:\n\n\n * In \nJune 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fjune-26-2026-maat-pharma-announces-plan-to-request-re-examination-following-negative-chmp-opinion-for-maat013-for-the-treatment-of-acute-graft-versus-host-disease%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=June+2026&index=4&md5=e70da9a2805aaa3ca8682d63c322cb8a)\n\n, MaaT Pharma announced that the CHMP of the European Medicine Agency (EMA)\nadopted a negative opinion on the conditional MAA for MaaT013(Xervyteg®) for\nthe treatment of aGvHD in adult patients with gastrointestinal involvement\nrefractory to prior lines of therapy, confirming the previously announced\nnegative trend opinion \ndisclosed on May 20, 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fmay-20-2026-maat-pharma-provides-an-update-on-the-application-for-marketing-authorization-of-maat013-xervyteg-in-the-treatment-of-acute-graft-versus-host-disease%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=disclosed+on+May+20%2C+2026&index=5&md5=1b78f8cc51d9da956703db3655b8cb0b)\n\n. At that time, the Company confirmed its plan to seek re-examination of the\nopinion.\n\n * As a post-period event, in \nSeptember 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fseptember-18-2026-maat-pharma-provides-update-on-maat013-xervyteg-potential-development-plan-following-chmp-negative-opinion-after-re-examination%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=September+2026&index=6&md5=f04d106d9b5e137fd384888c6ffaa88d)\n\n, the Company announced that the CHMP of the EMA had maintained its negative\nopinion on the CMA application for MaaT013 following re-examination. During\nthe application process, MaaT Pharma proposed conducting a randomized\ncontrolled Phase 3 trial versus Best Available Therapy (BAT), named PHOENIX,\nwhich is intended to support potential future regulatory submissions in the\nU.S., Europe and other selected territories, subject to further regulatory\nfeedback, successful execution and positive results.\n\nIn the US and globally:\n\n\n * As a post-period event, in \nSeptember 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fseptember-18-2026-maat-pharma-provides-update-on-maat013-xervyteg-potential-development-plan-following-chmp-negative-opinion-after-re-examination%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=September+2026&index=7&md5=b722ad8e158c730fb597a6c3ea92b580)\n\n, MaaT Pharma announced progress in U.S. clinical readiness for PHOENIX,\nsupported by feedback from a Type C interaction with the FDA and the\ncompletion of a feasibility assessment across major clinical trial sites.\n\n * Subject to appropriate funding and regulatory clearance, PHOENIX is intended\nto be conducted across the U.S., Europe and other regions as a proposed\nregistrational Phase 3 trial, potentially supporting future registration\nsubmissions subject to successful execution and positive results.\n\nAllogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033\n\n\n * PHOEBUS is a randomized clinical trial vs placebo evaluating MaaT033 in\npatients receiving allo-HSCT. Under the current development plan, the last\npatient is expected to be enrolled in the fourth quarter of 2027, with topline\nresults for one-year overall survival anticipated in the fourth quarter of\n2028.\n\n * In \nMarch 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fmarch-9-2026-maat-pharma-to-present-four-abstracts-at-the-52nd-european-bone-marrow-transplantation-annual-meeting-and-to-highlight-clinigen-hosted-industry-symposium-on-acute-gvhd-management%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=March+2026&index=8&md5=2b875e953ea0da95962915616b3bfa9b)\n\n, the Company presented a poster at the EBMT 2026 Annual Meeting.\n\nIn Immuno-Oncology\n\nMaaT034 - Next-generation drug candidates with co-cultured technology\n\n\n * MaaT034, a microbiome ecosystem therapy, is designed to be a universal\nMicrobiome combination partner for immunotherapies, improving outcomes in\npatients with ICI-refractory solid tumors, including NSCLC and melanoma.\n\n * As a post-period event, in \nSeptember 2026,\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fseptember-21-2026-maat-pharma-announces-upcoming-pre-ind-meeting-with-the-fda-and-advances-maat034-toward-clinical-development-in-solid-tumors%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=September+2026%2C&index=9&md5=3498c3cc9959e91ad590b4dc7fe915d6)\n\nMaaT Pharma announced that a CMC-focused Pre-IND meeting with the FDA was\nscheduled for October 2026, representing the next key regulatory milestone for\nMaaT034. A First-in-Human study in solid tumors, including second-line\nadvanced NSCLC and refractory advanced melanoma, has been designed to\ndetermine the optimal dosing and pre-treatment regimen and generate initial\nclinical proof-of-concept data. The study could be initiated in late 2027,\nsubject to appropriate funding and regulatory clearance.\n\nInvestigator-sponsored immuno-oncology studies\n\n\n * In \nJanuary 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fjanuary-20-2026-maat-pharma-announces-first-patient-randomized-in-immunolife-phase-2-study-sponsored-by-gustave-roussy-to-explore-the-role-of-the-gut-microbiome-to-overcome-ici-resistance-in-advanc%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=January+2026&index=10&md5=1b9c41d1d254318e38324c675df482e3)\n\n, MaaT Pharma announced its participation in IMMUNOLIFE, an\ninvestigator-sponsored Phase 2 study led by Gustave Roussy and designed to\nfurther explore the role of the gut microbiome and antibiotics in responses to\nimmune checkpoint inhibitors in advanced NSCLC.\n\n\n * The Company has also been informed that topline results from the\nacademic-sponsored PICASSO study may be available in 2026, subject to the\nsponsor’s timelines. The expected PICASSO data are intended to provide\ncomplementary insights and are not expected to directly impact MaaT034’s\ndevelopment strategy.\n\nIn the context of the CHMP outcome, the Company is conducting a strategic\nreview of its assets, which may result in adjustments to the associated\ndevelopment plans and timelines.\n\nKey Financial Results\n\nKey audited financial results for the first half of 2026 are as follows:\n\nIncome Statement\n In thousands of euros             2026.06        2025.06      \n                                   \n              \n            \n                                   \n(6 months)    \n(6 months)  \n                                                               \n Revenue                           1 079          2 427        \n Cost of Goods Sold                (105)          (790)        \n                                                               \n Gross Margin                      974            1 637        \n                                                               \n Other Income                      2 044          2 494        \n Sales and distribution costs      -              (491)        \n General and administrative costs  (2 822)        (3 611)      \n Research and development costs    (19 200)       (14 778)     \n                                                               \n Operating Income (loss)           (19 004)       (14 749)     \n                                                               \n Financial Income                  1 472          87           \n Financial Expense                 (800)          (422)        \n Net financial income (expense)    672            (336)        \n                                                               \n Income (loss) before income tax   (18 331)       (15 085)     \n                                                               \n Income tax expense                -              -            \n                                                               \n Net Income (loss) for the period  (18 331)       (15 085)     \n\n\nPrepared in accordance with international accounting standards IFRS\n\nRevenues totaled €1.1 million as of June 30, 2026, compared with €2.4\nmillion on June 30, 2025. The 55% decrease was mostly driven by the evolution\nof the EAP revenue model, following the implementation as of January 2026 of\nthe Clinigen Licensing Agreement. Revenues now consist of transfer price and\nroyalties, while the number of EAP patient treatments remained globally stable\n(-4%). Under the licensing agreement, Sales and Distribution costs were also\ntransferred to Clinigen.\n\nOperating loss was €18.3 million in the first half of 2026 compared with\n€15.1 million in the first half of 2025. The €3.2 million loss increase\nwas mostly attributable to research and development costs, which progressed\nfrom €14.8 million in the first half of 2025 to €19.2 million in the first\nhalf of 2026, consistent with the advancement of the Company’s late-stage\nclinical programs, in particular with the data analysis and regulatory\nactivities for MaaT013 (Xervyteg(®)) and with the ongoing patient recruitment\nin the PHOEBUS Phase 2b trial in allogeneic-HSCT with MaaT033.\n\nIncome statement for the first half of 2026 also reflects accounting\ndepreciation of certain assets, with the impairment review following the\nnegative European regulatory outcome for the MaaT013 (Xervyteg(®))\nconditional MAA.\n\nCash Position\n\nAs of June 30, 2026, total cash and cash equivalents were €17.1 million,\ncompared with €24.9 million as of December 31, 2025. In the current context,\nthe Company is conducting a strategic review of its assets while taking cash\npreservation measures with cash horizon now extended to December 2026 (vs\nNovember 2026), based on current operational assumptions.\n\nOver the first half of 2026, net cash utilization was €7.8 million. Net cash\nused in Operating and Investment activities was €15.0 million, while cash\ngenerated in Net Financing activities was €7.2 million and included the\n€6.0 million drawdown of the second tranche of the European Investment Bank\nloan and €2.4 million of project loan from Bpifrance.\n\nThe Company has updated its corporate presentation available on its website:\nwww.maatpharma.com/investors\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Finvestors%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=www.maatpharma.com%2Finvestors&index=11&md5=f153a8dc83e1b0e059f5766162d8de6e)\nand has filed its half-year Financial Report to the AMF (Autorité des\nMarchés Financiers).\n\nFinancial calendar*\n\n\n * November 16, 2026: Publication of revenues & cash for Q3 2026\n\n*Indicative calendar that may be subject to change.\n\n---\n\nAbout MaaT Pharma\n\nMaaT Pharma is a leading, late-stage clinical company focused on developing\ninnovative gut microbiome-driven therapies to modulate the immune system and\nenhance cancer patient survival. Supported by a talented team committed to\nmaking a difference for patients worldwide, the Company was founded in 2014\nand is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in\nbringing the first microbiome-driven immunomodulator in oncology. Using its\nproprietary pooling and co-cultivation technologies, MaaT Pharma develops high\ndiversity, standardized drug candidates, aiming at extending life of cancer\npatients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since\n2021.\n\nForward-looking Statements\n\nAll statements other than statements of historical fact included in this press\nrelease about future events are subject to (i) change without notice and (ii)\nfactors beyond the Company’s control. These statements may include, without\nlimitation, any statements preceded by, followed by, or including words such\nas “target,” “believe,” “expect,” “aim”, “intend,”\n“may,” “anticipate,” “estimate,” “plan,” “project,”\n“will,” “can have,” “likely,” “should,” “would,”\n“could” and other words and terms of similar meaning or the negative\nthereof. Forward-looking statements are subject to inherent risks and\nuncertainties beyond the Company’s control that could cause the Company’s\nactual results or performance to be materially different from the expected\nresults or performance expressed or implied by such forward-looking\nstatements.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260929202254/en/\n(https://www.businesswire.com/news/home/20260929202254/en/)\n\nMaaT Pharma – Investor Relations\n\nEric Soyer\n\nChief Financial Officer\n\n+33 4 28 29 14 00\n\ninvest@maat-pharma.com (mailto:invest@maat-pharma.com)\n\nMaaT Pharma – Media Relations\n\nPauline Richaud\n\nHead of Communication\n\n+33 6 14 06 45 92\n\nmedia@maat-pharma.com (mailto:media@maat-pharma.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw4DdRs7a-20260929","title":"MaaT Pharma Publishes its Half-Year 2026 Results and Provides a Business Update","author":"Business Wire","ticker":"MAAT","created":"2026-09-29T16:00:00.226Z","tickers":["MAAT"],"exchange":"Euronext Paris","article_body":"MaaT Pharma Publishes its Half-Year 2026 Results and Provides a Business\nUpdate\n\n\n * MaaT013 (Xervyteg(®)):\n\n\n* In September 2026, following the re-examination procedure, the CHMP\nmaintained\nits negative opinion on the Conditional Marketing Authorization Application\n(MAA) for MaaT013 (Xervyteg(®)).\n\n * Feedback received through a Type C interaction with the U.S. Food and Drug\nAdministration (FDA) contributes to the preparation of PHOENIX as a proposed\nregistrational Phase 3 trial and provides a framework for finalizing the\nprotocol and progressing U.S. development activities.\n\n\n\n\n * MaaT034: CMC-focused pre-Investigational New Drug (IND) meeting with the U.S.\nFDA, focused on CMC (Chemistry, Manufacturing and Controls) activities,\nscheduled for October 2026.\n\n * Revenue of €1.1 million in H1 2026, compared with €2.4 million in H1 2025,\nmostly driven by the impact of the Clinigen Licensing Agreement as of January\n1, 2026, while patient demand in the Early Access Program (EAP) remained\nglobally stable.\n\n * Cash and cash equivalents of €17.1 million as of June 30, 2026.\n\n * Cash runway now estimated to extend to December 2026 based on the Company’s\ncurrent operating plan.\n\n * The Company is exploring financing opportunities from investors and strategic\npartnerships\n\nRegulatory News:\n\nMaaT Pharma\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=MaaT+Pharma&index=1&md5=0db279468343f883fb4a4711f9caf511)\n(EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company\nand a leader in the development of Microbiome Ecosystem Therapies(TM )(MET)\ndedicated to enhancing survival for patients with cancer through immune\nmodulation, today announced its half-year financial results for the six-month\nperiod ended June 30, 2026, and provided a business update.\n\n“In the first half of 2026, the Company continued to advance its development\npipeline.\n\nFollowing the negative CHMP opinion on MaaT013 (Xervyteg(®)), we initiated a\ncomprehensive review of our portfolio and operating priorities. The measures\nimplemented extend, based on our current estimates, our cash runway to\nDecember 2026, while we continue to actively explore financing and strategic\npartnership opportunities to support the Company’s priority programs”\nstated Eric Soyer, CFO of MaaT Pharma.\n\nPipeline highlights\n\nIn Hemato-Oncology\n\nAcute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg(®))\n\n\n * In January 2026, MaaT Pharma transitioned the Early Access Program in Europe\nto Clinigen. As of June 30, 2026 and since 2019, more than 550 authorizations\nhave been given under the Early Access Program in 14 different countries.\n\n * In \nMarch 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fmarch-9-2026-maat-pharma-to-present-four-abstracts-at-the-52nd-european-bone-marrow-transplantation-annual-meeting-and-to-highlight-clinigen-hosted-industry-symposium-on-acute-gvhd-management%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=March+2026&index=2&md5=ed5223e1a080e1b819fd68fafdd5618f)\n\n, at the European Society for Blood and Marrow Transplantation (EBMT) 2026\nAnnual Meeting, MaaT Pharma presented final results from the ARES trial\nevaluating MaaT013 (Xervyteg(®)) in aGvHD. The Company also presented CHRONOS\nreal-world data, reporting 29% 12-month overall survival and 37% Day-28 GI-ORR\nin third-line patients treated with therapies other than microbiome-based\ntreatments. Clinigen hosted a dedicated symposium on steroid-refractory\nGI-aGvHD.\n\n * In \nApril 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fapril-1st-2026-maat-pharma-announces-publication-of-retrospective-data-in-third-line-acute-gvhd-from-the-chronos-study-in-bone-marrow-transplantation-journal-2%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=April+2026&index=3&md5=bb963b063fa48fcdfb695163cdf61bd3)\n\n, the CHRONOS study was published in Bone Marrow Transplantation, a\npeer-reviewed journal.\n\n * MaaT013 (Xervyteg(®)) Regulatory Evaluation:\n\nIn Europe:\n\n\n * In \nJune 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fjune-26-2026-maat-pharma-announces-plan-to-request-re-examination-following-negative-chmp-opinion-for-maat013-for-the-treatment-of-acute-graft-versus-host-disease%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=June+2026&index=4&md5=e70da9a2805aaa3ca8682d63c322cb8a)\n\n, MaaT Pharma announced that the CHMP of the European Medicine Agency (EMA)\nadopted a negative opinion on the conditional MAA for MaaT013(Xervyteg®) for\nthe treatment of aGvHD in adult patients with gastrointestinal involvement\nrefractory to prior lines of therapy, confirming the previously announced\nnegative trend opinion \ndisclosed on May 20, 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fmay-20-2026-maat-pharma-provides-an-update-on-the-application-for-marketing-authorization-of-maat013-xervyteg-in-the-treatment-of-acute-graft-versus-host-disease%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=disclosed+on+May+20%2C+2026&index=5&md5=1b78f8cc51d9da956703db3655b8cb0b)\n\n. At that time, the Company confirmed its plan to seek re-examination of the\nopinion.\n\n * As a post-period event, in \nSeptember 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fseptember-18-2026-maat-pharma-provides-update-on-maat013-xervyteg-potential-development-plan-following-chmp-negative-opinion-after-re-examination%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=September+2026&index=6&md5=f04d106d9b5e137fd384888c6ffaa88d)\n\n, the Company announced that the CHMP of the EMA had maintained its negative\nopinion on the CMA application for MaaT013 following re-examination. During\nthe application process, MaaT Pharma proposed conducting a randomized\ncontrolled Phase 3 trial versus Best Available Therapy (BAT), named PHOENIX,\nwhich is intended to support potential future regulatory submissions in the\nU.S., Europe and other selected territories, subject to further regulatory\nfeedback, successful execution and positive results.\n\nIn the US and globally:\n\n\n * As a post-period event, in \nSeptember 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fseptember-18-2026-maat-pharma-provides-update-on-maat013-xervyteg-potential-development-plan-following-chmp-negative-opinion-after-re-examination%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=September+2026&index=7&md5=b722ad8e158c730fb597a6c3ea92b580)\n\n, MaaT Pharma announced progress in U.S. clinical readiness for PHOENIX,\nsupported by feedback from a Type C interaction with the FDA and the\ncompletion of a feasibility assessment across major clinical trial sites.\n\n * Subject to appropriate funding and regulatory clearance, PHOENIX is intended\nto be conducted across the U.S., Europe and other regions as a proposed\nregistrational Phase 3 trial, potentially supporting future registration\nsubmissions subject to successful execution and positive results.\n\nAllogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033\n\n\n * PHOEBUS is a randomized clinical trial vs placebo evaluating MaaT033 in\npatients receiving allo-HSCT. Under the current development plan, the last\npatient is expected to be enrolled in the fourth quarter of 2027, with topline\nresults for one-year overall survival anticipated in the fourth quarter of\n2028.\n\n * In \nMarch 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fmarch-9-2026-maat-pharma-to-present-four-abstracts-at-the-52nd-european-bone-marrow-transplantation-annual-meeting-and-to-highlight-clinigen-hosted-industry-symposium-on-acute-gvhd-management%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=March+2026&index=8&md5=2b875e953ea0da95962915616b3bfa9b)\n\n, the Company presented a poster at the EBMT 2026 Annual Meeting.\n\nIn Immuno-Oncology\n\nMaaT034 - Next-generation drug candidates with co-cultured technology\n\n\n * MaaT034, a microbiome ecosystem therapy, is designed to be a universal\nMicrobiome combination partner for immunotherapies, improving outcomes in\npatients with ICI-refractory solid tumors, including NSCLC and melanoma.\n\n * As a post-period event, in \nSeptember 2026,\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fseptember-21-2026-maat-pharma-announces-upcoming-pre-ind-meeting-with-the-fda-and-advances-maat034-toward-clinical-development-in-solid-tumors%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=September+2026%2C&index=9&md5=3498c3cc9959e91ad590b4dc7fe915d6)\n\nMaaT Pharma announced that a CMC-focused Pre-IND meeting with the FDA was\nscheduled for October 2026, representing the next key regulatory milestone for\nMaaT034. A First-in-Human study in solid tumors, including second-line\nadvanced NSCLC and refractory advanced melanoma, has been designed to\ndetermine the optimal dosing and pre-treatment regimen and generate initial\nclinical proof-of-concept data. The study could be initiated in late 2027,\nsubject to appropriate funding and regulatory clearance.\n\nInvestigator-sponsored immuno-oncology studies\n\n\n * In \nJanuary 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Fjanuary-20-2026-maat-pharma-announces-first-patient-randomized-in-immunolife-phase-2-study-sponsored-by-gustave-roussy-to-explore-the-role-of-the-gut-microbiome-to-overcome-ici-resistance-in-advanc%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=January+2026&index=10&md5=1b9c41d1d254318e38324c675df482e3)\n\n, MaaT Pharma announced its participation in IMMUNOLIFE, an\ninvestigator-sponsored Phase 2 study led by Gustave Roussy and designed to\nfurther explore the role of the gut microbiome and antibiotics in responses to\nimmune checkpoint inhibitors in advanced NSCLC.\n\n\n * The Company has also been informed that topline results from the\nacademic-sponsored PICASSO study may be available in 2026, subject to the\nsponsor’s timelines. The expected PICASSO data are intended to provide\ncomplementary insights and are not expected to directly impact MaaT034’s\ndevelopment strategy.\n\nIn the context of the CHMP outcome, the Company is conducting a strategic\nreview of its assets, which may result in adjustments to the associated\ndevelopment plans and timelines.\n\nKey Financial Results\n\nKey audited financial results for the first half of 2026 are as follows:\n\nIncome Statement\n In thousands of euros             2026.06        2025.06      \n                                   \n              \n            \n                                   \n(6 months)    \n(6 months)  \n                                                               \n Revenue                           1 079          2 427        \n Cost of Goods Sold                (105)          (790)        \n                                                               \n Gross Margin                      974            1 637        \n                                                               \n Other Income                      2 044          2 494        \n Sales and distribution costs      -              (491)        \n General and administrative costs  (2 822)        (3 611)      \n Research and development costs    (19 200)       (14 778)     \n                                                               \n Operating Income (loss)           (19 004)       (14 749)     \n                                                               \n Financial Income                  1 472          87           \n Financial Expense                 (800)          (422)        \n Net financial income (expense)    672            (336)        \n                                                               \n Income (loss) before income tax   (18 331)       (15 085)     \n                                                               \n Income tax expense                -              -            \n                                                               \n Net Income (loss) for the period  (18 331)       (15 085)     \n\n\nPrepared in accordance with international accounting standards IFRS\n\nRevenues totaled €1.1 million as of June 30, 2026, compared with €2.4\nmillion on June 30, 2025. The 55% decrease was mostly driven by the evolution\nof the EAP revenue model, following the implementation as of January 2026 of\nthe Clinigen Licensing Agreement. Revenues now consist of transfer price and\nroyalties, while the number of EAP patient treatments remained globally stable\n(-4%). Under the licensing agreement, Sales and Distribution costs were also\ntransferred to Clinigen.\n\nOperating loss was €18.3 million in the first half of 2026 compared with\n€15.1 million in the first half of 2025. The €3.2 million loss increase\nwas mostly attributable to research and development costs, which progressed\nfrom €14.8 million in the first half of 2025 to €19.2 million in the first\nhalf of 2026, consistent with the advancement of the Company’s late-stage\nclinical programs, in particular with the data analysis and regulatory\nactivities for MaaT013 (Xervyteg(®)) and with the ongoing patient recruitment\nin the PHOEBUS Phase 2b trial in allogeneic-HSCT with MaaT033.\n\nIncome statement for the first half of 2026 also reflects accounting\ndepreciation of certain assets, with the impairment review following the\nnegative European regulatory outcome for the MaaT013 (Xervyteg(®))\nconditional MAA.\n\nCash Position\n\nAs of June 30, 2026, total cash and cash equivalents were €17.1 million,\ncompared with €24.9 million as of December 31, 2025. In the current context,\nthe Company is conducting a strategic review of its assets while taking cash\npreservation measures with cash horizon now extended to December 2026 (vs\nNovember 2026), based on current operational assumptions.\n\nOver the first half of 2026, net cash utilization was €7.8 million. Net cash\nused in Operating and Investment activities was €15.0 million, while cash\ngenerated in Net Financing activities was €7.2 million and included the\n€6.0 million drawdown of the second tranche of the European Investment Bank\nloan and €2.4 million of project loan from Bpifrance.\n\nThe Company has updated its corporate presentation available on its website:\nwww.maatpharma.com/investors\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.maatpharma.com%2Finvestors%2F&esheet=54612600&newsitemid=20260929202254&lan=en-US&anchor=www.maatpharma.com%2Finvestors&index=11&md5=f153a8dc83e1b0e059f5766162d8de6e)\nand has filed its half-year Financial Report to the AMF (Autorité des\nMarchés Financiers).\n\nFinancial calendar*\n\n\n * November 16, 2026: Publication of revenues & cash for Q3 2026\n\n*Indicative calendar that may be subject to change.\n\n---\n\nAbout MaaT Pharma\n\nMaaT Pharma is a leading, late-stage clinical company focused on developing\ninnovative gut microbiome-driven therapies to modulate the immune system and\nenhance cancer patient survival. Supported by a talented team committed to\nmaking a difference for patients worldwide, the Company was founded in 2014\nand is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in\nbringing the first microbiome-driven immunomodulator in oncology. Using its\nproprietary pooling and co-cultivation technologies, MaaT Pharma develops high\ndiversity, standardized drug candidates, aiming at extending life of cancer\npatients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since\n2021.\n\nForward-looking Statements\n\nAll statements other than statements of historical fact included in this press\nrelease about future events are subject to (i) change without notice and (ii)\nfactors beyond the Company’s control. These statements may include, without\nlimitation, any statements preceded by, followed by, or including words such\nas “target,” “believe,” “expect,” “aim”, “intend,”\n“may,” “anticipate,” “estimate,” “plan,” “project,”\n“will,” “can have,” “likely,” “should,” “would,”\n“could” and other words and terms of similar meaning or the negative\nthereof. Forward-looking statements are subject to inherent risks and\nuncertainties beyond the Company’s control that could cause the Company’s\nactual results or performance to be materially different from the expected\nresults or performance expressed or implied by such forward-looking\nstatements.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260929202254/en/\n(https://www.businesswire.com/news/home/20260929202254/en/)\n\nMaaT Pharma – Investor Relations\n\nEric Soyer\n\nChief Financial Officer\n\n+33 4 28 29 14 00\n\ninvest@maat-pharma.com (mailto:invest@maat-pharma.com)\n\nMaaT Pharma – Media Relations\n\nPauline Richaud\n\nHead of Communication\n\n+33 6 14 06 45 92\n\nmedia@maat-pharma.com (mailto:media@maat-pharma.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-09-29T16:00:00.341173129Z","server_sent_at_ms":1790697600341},"received_at":"2026-09-29T16:00:00.400Z","source_url":"https://www.businesswire.com/news/home/20260929202254/en/"},"analysis":{"id":"144503","press_release_id":"155778","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["CHMP maintained negative opinion on lead asset MaaT013 after re-examination","cash runway only extends to December 2026; financing not yet secured","revenue down 55% YoY following EAP transition to Clinigen","strategic review of assets may alter development plans; impairment recorded"],"eventType":"earnings","narrative":"MaaT Pharma reported H1 2026 revenue of €1.1 million, down 55% year-over-year, with a net loss of €18.3 million versus €15.1 million a year earlier.\n\nThe CHMP maintained its negative opinion on the MaaT013 (Xervyteg) conditional marketing application after re-examination, prompting a strategic review of assets and an impairment of related assets.\n\nCash stood at €17.1 million as of June 30, 2026, with runway extended to December 2026 via cost measures; the company is actively exploring financing and strategic partnerships.\n\nU.S. development continues: FDA Type C feedback supports the proposed registrational Phase 3 PHOENIX trial for MaaT013, and a pre-IND meeting for MaaT034 is scheduled for October 2026.","sentiment":"bearish","agentHooks":{"shouldPost":true,"suggestedAngle":"Lead asset rejected in Europe and runway to December 2026 -- MaaT Pharma is a financing-event watch."},"keyFigures":{"revenue":"€1.1 million","guidance":"","revenueYoy":"-55%","customDimensions":{"rd_costs":"€19.2 million","cash_runway":"December 2026","operating_loss":"€-18.3 million","net_income_loss":"€-18.3 million","cash_and_equivalents":"€17.1 million","net_cash_utilization_h1":"€7.8 million"}},"quotedText":"The measures implemented extend, based on our current estimates, our cash runway to December 2026, while we continue to actively explore financing and strategic partnership opportunities to support the Company's priority programs","namedEntities":{"people":[{"name":"Eric Soyer","role":"CFO"},{"name":"Pauline Richaud","role":"Head of Communication"}],"products":["MaaT013 (Xervyteg)","MaaT033","MaaT034","PHOENIX","PHOEBUS","ARES","CHRONOS","IMMUNOLIFE","PICASSO"],"companies":[{"name":"MaaT Pharma","ticker":"MAAT","relationship":"filer"},{"name":"Clinigen","relationship":"partner"},{"name":"European Medicines Agency (EMA/CHMP)","relationship":"regulator"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"European Investment Bank","relationship":"lender"},{"name":"Bpifrance","relationship":"lender"},{"name":"Gustave Roussy","relationship":"academic partner"},{"name":"AMF (Autorité des Marchés Financiers)","relationship":"regulator"}],"dollarAmounts":[{"amount":"€1.1 million","context":"H1 2026 revenue"},{"amount":"€2.4 million","context":"H1 2025 revenue"},{"amount":"€17.1 million","context":"cash and cash equivalents as of June 30, 2026"},{"amount":"€18.3 million","context":"H1 2026 net loss"},{"amount":"€19.2 million","context":"H1 2026 R&D costs"},{"amount":"€7.8 million","context":"net cash utilization in H1 2026"},{"amount":"€6.0 million","context":"EIB loan second tranche drawdown"},{"amount":"€2.4 million","context":"Bpifrance project loan"}]},"materialImpact":{"score":4,"reasoning":"CHMP maintained its negative opinion on MaaT013 after re-examination, killing near-term EU approval for the lead asset, revenue fell 55%, and the cash runway only extends to December 2026 with financing still uncertain."},"tickerRelevance":{"others":[],"primary":"MAAT"},"globalImportance":25,"audienceRelevance":15,"eventTypeSecondary":["fda_rejection","operations_update"],"importanceComponents":{"tickerTier":"small-cap European biotech","eventGravity":"regulatory rejection of lead asset + going-concern-adjacent cash runway","issuerAuthored":true}},"event_type":"earnings","event_type_secondary":["fda_rejection","operations_update"],"sentiment":"bearish","material_impact_score":4,"narrative":"MaaT Pharma reported H1 2026 revenue of €1.1 million, down 55% year-over-year, with a net loss of €18.3 million versus €15.1 million a year earlier.\n\nThe CHMP maintained its negative opinion on the MaaT013 (Xervyteg) conditional marketing application after re-examination, prompting a strategic review of assets and an impairment of related assets.\n\nCash stood at €17.1 million as of June 30, 2026, with runway extended to December 2026 via cost measures; the company is actively exploring financing and strategic partnerships.\n\nU.S. development continues: FDA Type C feedback supports the proposed registrational Phase 3 PHOENIX trial for MaaT013, and a pre-IND meeting for MaaT034 is scheduled for October 2026.","key_figures":{"revenue":"€1.1 million","guidance":"","revenueYoy":"-55%","customDimensions":{"rd_costs":"€19.2 million","cash_runway":"December 2026","operating_loss":"€-18.3 million","net_income_loss":"€-18.3 million","cash_and_equivalents":"€17.1 million","net_cash_utilization_h1":"€7.8 million"}},"named_entities":{"people":[{"name":"Eric Soyer","role":"CFO"},{"name":"Pauline Richaud","role":"Head of Communication"}],"products":["MaaT013 (Xervyteg)","MaaT033","MaaT034","PHOENIX","PHOEBUS","ARES","CHRONOS","IMMUNOLIFE","PICASSO"],"companies":[{"name":"MaaT Pharma","ticker":"MAAT","relationship":"filer"},{"name":"Clinigen","relationship":"partner"},{"name":"European Medicines Agency (EMA/CHMP)","relationship":"regulator"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"European Investment Bank","relationship":"lender"},{"name":"Bpifrance","relationship":"lender"},{"name":"Gustave Roussy","relationship":"academic partner"},{"name":"AMF (Autorité des Marchés Financiers)","relationship":"regulator"}],"dollarAmounts":[{"amount":"€1.1 million","context":"H1 2026 revenue"},{"amount":"€2.4 million","context":"H1 2025 revenue"},{"amount":"€17.1 million","context":"cash and cash equivalents as of June 30, 2026"},{"amount":"€18.3 million","context":"H1 2026 net loss"},{"amount":"€19.2 million","context":"H1 2026 R&D costs"},{"amount":"€7.8 million","context":"net cash utilization in H1 2026"},{"amount":"€6.0 million","context":"EIB loan second tranche drawdown"},{"amount":"€2.4 million","context":"Bpifrance project loan"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-29T16:00:08.477Z","global_importance":25,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap European biotech","eventGravity":"regulatory rejection of lead asset + going-concern-adjacent cash runway","issuerAuthored":true}},"durationMs":8037,"modelName":"glm-5.3-flashx"}}