Business
MaaT Pharma Announces 2025 Annual Results and Provides Business Updates
LYON, France, March 31, 2026--MaaT Pharma Announces 2025 Annual Results and Provides Business Updates
About this update from Maat Pharma
LYON, France, March 31, 2026 --( BUSINESS WIRE )--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies™ (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today reports the 2025 full-year annual results and provides business updates. "2025 was a year of strong clinical momentum for MaaT Pharma, marked by major advances across our hemato-oncology portfolio and progress in immuno-oncology. In 2026, we are approaching a potentially transformative milestone with the EMA review of MaaT013 (Xervyteg ® ), while continuing to expand our oncology platform. We believe MaaT Pharma is well-positioned as a leader in microbiome-driven therapies and we remain focused on advancing our pipeline with the ambition to bring new therapeutic options to patients with high unmet needs, " stated Hervé Affagard, CEO and co-founder of MaaT Pharma. Pipeline highlights In Hemato-Oncology 2025 was an important year for MaaT Pharma, marked by continued progress for MaaT013 (Xervyteg ® ) and steps that reinforced the Company’s position in microbiome-based therapies in hemato-oncology. Looking ahead, 2026 is expected to be a pivotal year, as MaaT013 (Xervyteg ® ) advances through the EMA review process toward a potential first-in-class approval in oncology. The MAA submitted to the EMA is supported by results from the open-label, single-arm pivotal ARES trial, together with a dataset generated through the EAP. As a "first-in-class" potentially setting the foundations for future standards, MaaT013 (Xervyteg ® ) is being developed in the field of rare diseases and currently represents the Company’s most advanced drug candidate. Its development takes place in an environment characterized by specific pharmaceutical, clinical and regulatory questions, notably related to the innovative nature of its therapeutic approach. MaaT013 (Xervyteg ® ) is the most advanced step toward validating the Company’s oncology platform, which holds scalability potential, notably with MaaT033, an oral form, as the next expansion driver. Acute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg ® ) Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033 In Immuno-Oncology Leveraging the learnings of the MET-N platform in hemato-oncology, the MET-C platform represents a major mid-term inflection point for the Company. The Company has strengthened its platform with an enhanced co-cultivation manufacturing process and AI-enabled candidate design capabilities. Consistent with the Company’s stage-gate strategy, MaaT034 is being developed as the first drug candidate in the immuno-oncology portfolio. MaaT034 - Next-generation drug candidates with co-cultured technology Since 2022, the Company has implemented an exploratory strategy through two investigator-sponsored trials (IMMUNOLIFE sponsored by Gustave Roussy, and PICASSO, sponsored by AP-HP) using its donor-derived MET-N platform to better understand how the gut microbiome may overcome Immune-Checkpoint Inhibitors (ICI) resistance. Insights from these studies will inform on further development such as positioning across indications, treatment lines, and target populations. As a post period event, in January 2026 , MaaT Pharma announced that the first patient was randomized in the IMMUNOLIFE trial evaluating the potential of MaaT033 in combination with Regeneron’s Cemiplimab in enhancing disease control rate versus best investigator’s choice in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 blockade following antibiotic (ATB) exposure and who present ATB-induced gut dysbiosis. The Company has also been informed by PICASSO’s academic sponsor that topline results would not be available in Q4 2025 (as previously announced) and could now be expected in H1 2026. Company Updates Financial highlights The key financial audited results for the full year of 2025 are as follows. Condensed Income Statement Revenues totaled €4.5 million for the year ended December 31, 2025, mostly comprised of compensation invoiced from the Early Access Program in France: €4.4 million EAP revenues in 2025, vs €3.2 million in 2024, a €1.2 million/38% increase year-over-year reflecting a growing adoption in the hemato-oncology medical community. Other income of €4.4 million included R&D tax credits of €3.8 million in 2025, from €3.5 million in the prior year, and grants of €0.4 million in 2025, from €0.1 million in the prior year. Research and Development expenses were €29.1 million in 2025, an increase of €1.8 million from 2024, consistent with the advancement of clinical and operational activities as detailed in the pipeline highlights section above. Sales, General and Administrative expenses amounted to €8.2 million in 2025, compared with €6.9 million in 2024. The €1.3 million increase reflected higher sales & distribution expenses, in line with the increase in EAP revenues, increased expenses related to financing activities, and the strengthening of the team, including expert medical and regulatory consultants, to support the ongoing MAA process. As a result, operating expenses amounted to €29.7 million in 2025 compared with €28.4 million for 2024, an increase of €1.3 million. Net loss was €31.1 million for the year ended December 31, 2025, compared with €28.9 million for the year ended December 31, 2024. Cash Position and Financing As of December 31, 2025, total cash and cash equivalents were €24.9 million, as compared to €20.2 million as of December 31, 2024. The net increase in cash position of €4.7 million over the 12-month period between December 31, 2024, and December 31, 2025, was related to a net cash utilization in Operating and Investing activities of €16.0 million, while cash generated in financial activities was €20.7 million, including €20.8 million in net equity capital raises and €3.2 million from new loans, while loan repayments and interests amounted to €3.3 million. The Company estimates that its current cash position will enable it to finance its operations until June 2026, and until August 2026, taking into account the ongoing drawdown of Tranche B of the EIB loan, as previously announced. To strengthen its cash position, the Company could benefit from additional financing pursuant to the agreements signed in 2025, all of them subject to obtaining a Marketing Authorization for its drug candidate Xervyteg ® (MaaT013): a milestone payment of €12 million from Clinigen upon obtaining the Marketing Authorization, and the drawdown of Tranche C of the EIB loan for €8 million, subject in particular to the granting of the Marketing Authorization and contractual financing conditions. The Company also continues to seek additional financing to support the development of its development portfolio. Financial calendar* *Indicative calendar that may be subject to change. Upcoming conferences participation About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. Forward-looking Statements All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "aim", "intend," "may," "anticipate," "estimate," "plan," "project," "will," "can have," "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. View source version on businesswire.com: https://www.businesswire.com/news/home/20260330043869/en/ Contacts MaaT Pharma – Investor Relations Eric Soyer Chief Financial Officer +33 4 28 29 14 00 [email protected] MaaT Pharma – Media Relations Pauline Richaud Head of Communications +33 6 14 06 45 92 [email protected] Catalytic Agency – U.S. Media Relations Heather Shea Media relations for MaaT Pharma +1 617-286-2013 [email protected]