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October 19, 2026: 91��ɫ��Ƶ Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

91��ɫ��Ƶ — Mon, 19 Oct 2026 15:39:39 +0000

91��ɫ��Ƶ Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

Positive pre-Investigational New Drug (pre-IND) interaction with the Food Drug Administration (FDA) on Chemistry, Manufacturing and Controls (CMC) and nonclinical topics supports MaaT034’s continued advancement
FDA alignment on the IND-enabling strategy indicates that no additional non-clinical studies are anticipated to be required to support the safety of MaaT034 administration

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Lyon, France, October 19, 2026 – 6:30pm CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced productive and constructive feedback from the U.S. FDA following its pre-IND interaction for MaaT034 in potential solid tumor indications including Non-Small Cell Lung Cancer, Melanoma and Renal Cell Carcinoma, focused on CMC and nonclinical development.

Based on the information provided, and pending the receipt and confirmation of the FDA’s final meeting summary, the FDA indicated that 91��ɫ��Ƶ’s proposed science- and risk-based development approach appears appropriate, subject to review of the complete IND submission. The FDA also indicated that no additional nonclinical studies are required to support the safety of MaaT034 administration. The FDA requested additional information from completed studies for inclusion in the IND submission.

“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in 91��ɫ��Ƶ’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across cancer care,” said Hervé Affagard, CEO and co-founder of 91��ɫ��Ƶ.

91��ɫ��Ƶ plans to continue its IND-enabling activities and further engage with the FDA through a Type C meeting focused on the proposed clinical development plan and first-in-human study design.

Subject to obtaining the necessary regulatory clearances and the availability of appropriate funding and taking into account the Company’s estimated cash runway to December 2026, 91��ɫ��Ƶ could initiate a First-in-Human study evaluating MaaT034 in late 2027. To support the clinical development of MaaT034, the Company is exploring financing opportunities from investors and strategic partnerships.

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About 91��ɫ��Ƶ
91��ɫ��Ƶ 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, 91��ɫ��Ƶ is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91��ɫ��Ƶ develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91��ɫ��Ƶ has been listed on Euronext Paris (ticker: MAAT) since 2021.

About MaaT034
MaaT034, currently in preclinical development, is a next-generation donor-independent functionally selected, co-cultured microbial ecosystem, designed to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). Developed using 91��ɫ��Ƶ’s proprietary MET-C co-culturing platform, MaaT034 is optimized for large-scale manufacturing and designed to deliver key microbial functions associated with anti-tumor immune responses.
Preclinical data presented at the AACR and at SITC annual meetings demonstrated that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the potential of MaaT034 to promote gut barrier restoration, enhance T-cell activation, and increase anti-tumor activity when combined with anti-PD-1 or anti-PD-L1 therapies.
By restoring microbiome-mediated functions and modulating immune responses, MaaT034 is designed to complement the mechanism of action of immune checkpoint inhibitors and has the potential to improve treatment outcomes in patients with advanced solid tumors.

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.

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September 29, 2026: 91��ɫ��Ƶ Publishes its Half-Year 2026 Results and Provides a Business Update

91��ɫ��Ƶ — Tue, 29 Sep 2026 15:43:26 +0000

91��ɫ��Ƶ Publishes its Half-Year 2026 Results and Provides a Business Update

MaaT013 (Xervyteg®):
- In September 2026, following the re-examination procedure, the CHMP maintained its negative opinion on the Conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®).
- Feedback received through a Type C interaction with the U.S. Food and Drug Administration (FDA) contributes to the preparation of PHOENIX as a proposed registrational Phase 3 trial and provides a framework for finalizing the protocol and progressing U.S. development activities.
MaaT034: CMC-focused pre-Investigational New Drug (IND) meeting with the U.S. FDA, focused on CMC (Chemistry, Manufacturing and Controls) activities, scheduled for October 2026.
Revenue of €1.1 million in H1 2026, compared with €2.4 million in H1 2025, mostly driven by the impact of the Clinigen Licensing Agreement as of January 1, 2026, while patient demand in the Early Access Program (EAP) remained globally stable.
Cash and cash equivalents of €17.1 million as of June 30, 2026.
Cash runway now estimated to extend to December 2026 based on the Company’s current operating plan.
The Company is exploring financing opportunities from investors and strategic partnerships

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Lyon, France, September 29, 2026 – 6:00pm CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced its half-year financial results for the six-month period ended June 30, 2026, and provided a business update.

“In the first half of 2026, the Company continued to advance its development pipeline. Following the negative CHMP opinion on MaaT013 (Xervyteg^®), we initiated a comprehensive review of our portfolio and operating priorities. 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” stated Eric Soyer, CFO of 91��ɫ��Ƶ.

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Pipeline highlights

In Hemato-Oncology

Acute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg^®)

In January 2026, 91��ɫ��Ƶ transitioned the Early Access Program in Europe to Clinigen. As of June 30, 2026 and since 2019, more than 550 authorizations have been given under the Early Access Program in 14 different countries.
In March 2026, at the European Society for Blood and Marrow Transplantation (EBMT) 2026 Annual Meeting, 91��ɫ��Ƶ presented final results from the ARES trial evaluating MaaT013 (Xervyteg^®) in aGvHD. The Company also presented CHRONOS real-world data, reporting 29% 12-month overall survival and 37% Day-28 GI-ORR in third-line patients treated with therapies other than microbiome-based treatments. Clinigen hosted a dedicated symposium on steroid-refractory GI-aGvHD.
In April 2026, the CHRONOS study was published in Bone Marrow Transplantation, a peer-reviewed journal.
MaaT013 (Xervyteg^®) Regulatory Evaluation:

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In Europe:

- In June 2026, 91��ɫ��Ƶ announced that the CHMP of the European Medicine Agency (EMA) adopted a negative opinion on the conditional MAA for MaaT013 (Xervyteg^®) for the treatment of aGvHD in adult patients with gastrointestinal involvement refractory to prior lines of therapy, confirming the previously announced negative trend opinion disclosed on May 20, 2026. At that time, the Company confirmed its plan to seek re-examination of the opinion.
- As a post-period event, in September 2026, the Company announced that the CHMP of the EMA had maintained its negative opinion on the CMA application for MaaT013 following re-examination. During the application process, 91��ɫ��Ƶ proposed conducting a randomized controlled Phase 3 trial versus Best Available Therapy (BAT), named PHOENIX, which is intended to support potential future regulatory submissions in the U.S., Europe and other selected territories, subject to further regulatory feedback, successful execution and positive results.

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In the US and globally:

As a post-period event, in September 2026, 91��ɫ��Ƶ announced progress in U.S. clinical readiness for PHOENIX, supported by feedback from a Type C interaction with the FDA and the completion of a feasibility assessment across major clinical trial sites.
Subject to appropriate funding and regulatory clearance, PHOENIX is intended to be conducted across the U.S., Europe and other regions as a proposed registrational Phase 3 trial, potentially supporting future registration submissions subject to successful execution and positive results.

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Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) – MaaT033

PHOEBUS is a randomized clinical trial vs placebo evaluating MaaT033 in patients receiving allo-HSCT. Under the current development plan, the last patient is expected to be enrolled in the fourth quarter of 2027, with topline results for one-year overall survival anticipated in the fourth quarter of 2028.
In March 2026, the Company presented a poster at the EBMT 2026 Annual Meeting.

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In Immuno-Oncology

MaaT034 – Next-generation drug candidates with co-cultured technology

MaaT034, a microbiome ecosystem therapy, is designed to be a universal Microbiome combination partner for immunotherapies, improving outcomes in patients with ICI-refractory solid tumors, including NSCLC and melanoma.
As a post-period event, in September 2026, 91��ɫ��Ƶ announced that a CMC-focused Pre-IND meeting with the FDA was scheduled for October 2026, representing the next key regulatory milestone for MaaT034. A First-in-Human study in solid tumors, including second-line advanced NSCLC and refractory advanced melanoma, has been designed to determine the optimal dosing and pre-treatment regimen and generate initial clinical proof-of-concept data. The study could be initiated in late 2027, subject to appropriate funding and regulatory clearance.

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Investigator-sponsored immuno-oncology studies

In January 2026, 91��ɫ��Ƶ announced its participation in IMMUNOLIFE, an investigator-sponsored Phase 2 study led by Gustave Roussy and designed to further explore the role of the gut microbiome and antibiotics in responses to immune checkpoint inhibitors in advanced NSCLC.
The Company has also been informed that topline results from the academic-sponsored PICASSO study may be available in 2026, subject to the sponsor’s timelines. The expected PICASSO data are intended to provide complementary insights and are not expected to directly impact MaaT034’s development strategy.

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In the context of the CHMP outcome, the Company is conducting a strategic review of its assets, which may result in adjustments to the associated development plans and timelines.

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Key Financial Results

Key audited financial results for the first half of 2026 are as follows:

Income Statement

In thousands of euros	2026.06 (6 months)	2025.06 (6 months)
Revenue	1 079	2 427
Cost of Goods Sold	(105)	(790)
��Gross Margin	974	1 637
Other Income	2 044	2 494
Sales and distribution costs	–	(491)
General and administrative costs	(2 822)	(3 611)
Research and development costs	(19 200)	(14 778)
��Operating Income (loss)	(19 004)	(14 749)
Financial Income	1 472	87
Financial Expense	(800)	(422)
��Net financial income (expense)	672	(336)
��Income (loss) before income tax	(18 331)	(15 085)
Income tax expense	��–	��–
Net Income (loss) for the period	(18 331)	(15 085)

Prepared in accordance with international accounting standards IFRS

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Revenues totaled €1.1 million as of June 30, 2026, compared with €2.4 million on June 30, 2025. The 55% decrease was mostly driven by the evolution of the EAP revenue model, following the implementation as of January 2026 of the Clinigen Licensing Agreement. Revenues now consist of transfer price and royalties, while the number of EAP patient treatments remained globally stable (-4%). Under the licensing agreement, Sales and Distribution costs were also transferred to Clinigen.

Operating loss was €18.3 million in the first half of 2026 compared with €15.1 million in the first half of 2025. The €3.2 million loss increase was mostly attributable to research and development costs, which progressed from €14.8 million in the first half of 2025 to €19.2 million in the first half of 2026, consistent with the advancement of the Company’s late-stage clinical programs, in particular with the data analysis and regulatory activities for MaaT013 (Xervyteg^®) and with the ongoing patient recruitment in the PHOEBUS Phase 2b trial in allogeneic-HSCT with MaaT033.

Income statement for the first half of 2026 also reflects accounting depreciation of certain assets, with the impairment review following the negative European regulatory outcome for the MaaT013 (Xervyteg^®) conditional MAA.

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Cash Position

As of June 30, 2026, total cash and cash equivalents were €17.1 million, compared with
€24.9 million as of December 31, 2025. In the current context, the Company is conducting a strategic review of its assets while taking cash preservation measures with cash horizon now extended to December 2026 (vs November 2026), based on current operational assumptions.

Over the first half of 2026, net cash utilization was €7.8 million. Net cash used in Operating and Investment activities was €15.0 million, while cash generated in Net Financing activities was €7.2 million and included the €6.0 million drawdown of the second tranche of the European Investment Bank loan and €2.4 million of project loan from Bpifrance.

The Company has updated its corporate presentation available on its website: www.maatpharma.com/investors and has filed its half-year Financial Report to the AMF (Autorité des Marchés Financiers).

Financial calendar*

November 16, 2026: Publication of revenues & cash for Q3 2026

*Indicative calendar that may be subject to change.

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September 21, 2026: 91��ɫ��Ƶ Announces Upcoming Pre-IND Meeting with the FDA and Advances MaaT034 Toward Clinical Development in Solid Tumors

91��ɫ��Ƶ — Mon, 21 Sep 2026 16:05:22 +0000

91��ɫ��Ƶ Announces Upcoming Pre-IND Meeting with the FDA and Advances MaaT034 Toward Clinical Development in Solid Tumors

Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA), focused on CMC (Chemistry, Manufacturing, and Controls), is scheduled for October 2026, representing the next key regulatory milestone for MaaT034
A First-in-Human study has been designed to determine the optimal dosing and pre-treatment regimen and generate initial clinical proof-of-concept data
Initial clinical development planned in combination with PD-(L)1 inhibitors in solid tumors with high unmet medical needs and limited treatment options, including second-line advanced non-small cell lung cancer (NSCLC), refractory advanced melanoma and other solid tumors
The First-in-Human study could be initiated in late 2027, subject to obtaining the appropriate funding and necessary regulatory clearance

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Lyon, France, September 21, 2026 – 7:00pm CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the next clinical development steps for MaaT034, the first functionally-selected, co-cultured microbial ecosystem from the Company’s innovative donor-independent MET-C platform, to be evaluated in combination with PD-(L)1 inhibitors in advanced solid tumors.

The MET-C platform combines rational candidate design, artificial intelligence-enabled computational tools for functional feature selection and unique co-culture technology to produce functionally selected microbial ecosystems at an industrial scale. MaaT034 is the first candidate to emerge from this platform and is specifically designed with the objective of optimizing intestinal microbiome functions and to support antitumor immune responses in combination with immune checkpoint inhibitors.

91��ɫ��Ƶ has scheduled a Pre-IND CMC-focused meeting with the FDA in October 2026, the next regulatory milestone toward clinical development of MaaT034. The program’s progression toward clinical development is based on a series of preclinical findings presented at the AACR and SITC Annual Meetings¹.

MaaT034 is expected to be developed in combination with PD-(L)1 inhibitors in selected advanced solid tumors, including second-line NSCLC and refractory advanced melanoma, as well as in other solid tumors characterized by significant unmet medical needs and limited treatment options. By modulating the gut microbiome, MaaT034 is designed to help restore anti-tumor immunity and sensitivity to PD-(L)1 inhibitors, with the aim of overcoming acquired resistance and improving outcomes beyond current standard of care benchmarks.

Subject to obtaining the necessary regulatory clearances and the availability of appropriate funding, 91��ɫ��Ƶ could initiate a First-in-Human study evaluating MaaT034 in late 2027. To support the clinical development of MaaT034, the Company is exploring financing opportunities from investors and strategic partnerships with pharmaceutical companies.

[1] Preclinical data for MaaT034 have been presented at AACR and SITC annual meetings since 2023. Posters are available in the dedicated section of the Company’s website.

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September 14, 2026: MaaT013 fecal microbiotherapy modulates key gastro-intestinal and immunological processes involved in GvHD pathogenesis in vitro and in vivo – Frontiers

91��ɫ��Ƶ — Fri, 18 Sep 2026 10:12:50 +0000

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September 18, 2026: 91��ɫ��Ƶ Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination

91��ɫ��Ƶ — Fri, 18 Sep 2026 04:34:32 +0000

91��ɫ��Ƶ Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the Company’s application for a Conditional Marketing Authorization (CMA) for MaaT013 (Xervyteg®), confirming the trend communicated on September 15, 2026, following the Oral Explanation
During the application process, 91��ɫ��Ƶ proposed conducting a randomized controlled Phase 3 trial versus Best Available Therapy (BAT), named PHOENIX, which would serve the purpose of regulatory submission in the U.S., Europe and other territories
Food and Drug Administration (FDA) Type C feedback supports advancement of the pivotal PHOENIX Phase 3 trial which could enable study initiation leading to a potential first patient enrollment in H1 2027, subject to appropriate funding and regulatory clearance

Lyon, France, September 18, 2026 – 7:30am CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that the CHMP of the EMA has maintained its negative opinion on the CMA application for MaaT013, under the brand name Xervyteg®, for the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy following re-examination. The European Commission is expected to issue its final decision following the CHMP opinion in accordance with the applicable regulatory process¹. The Company also indicates that future developments of MaaT013 (Xervyteg®) will focus on advancing the PHOENIX randomized clinical trial, subject to appropriate financing and regulatory clearance. The Company is actively exploring options to start U.S. focused development plan for MaaT013 (Xervyteg®) with a view to enabling potential global registration.

The CHMP maintained its view in its formal opinion adopted on September 18, 2026 that the available clinical data package based on single arm trial does not allow sufficient characterization of the benefit-risk profile of MaaT013 (Xervyteg®). As part of the re-examination process, 91��ɫ��Ƶ presented plans for PHOENIX, a global randomized controlled Phase 3 trial intended to generate the additional evidence requested by regulators to further characterize the benefit-risk profile of MaaT013.

91��ɫ��Ƶ is advancing the U.S. clinical readiness for PHOENIX, including completion of a feasibility assessment across major clinical trial sites in US and other planned countries. In addition, feedback received following a Type C interaction with the FDA supports advancement of PHOENIX as a registrational Phase 3 trial and provides a framework for finalizing the study protocol and progressing U.S. development activities, including clinical site activation.

Subject to appropriate funding and regulatory clearance, PHOENIX is planned to be conducted across the U.S., Europe and sites in other regions and could also support potential future registration submissions, subject to successful execution and positive results.

PHOENIX is a randomized, controlled, open-label Phase 3 trial evaluating MaaT013 (Xervyteg®) versus pre-specified BAT in patients with corticosteroid- and ruxolitinib-refractory aGvHD. The study is expected to enroll approximately 138 patients randomized 1:1 and will evaluate Day 28 all-organ Overall Response Rate as its primary endpoint, alongside key secondary efficacy and safety endpoints.

In this context, the Company is conducting a strategic review of its assets while taking additional cash preservation measures, to further extend its cash horizon to December 2026 (vs November 2026), based on current operational assumptions.

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About acute Graft-versus-Host Disease
Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient’s organs, causing inflammation of the skin, liver and/or gastrointestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first-line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered steroid resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) on March 25, 2022.

About MaaT013 (Xervyteg®)
91��ɫ��Ƶ’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013��is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. ��MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem Therapy^TM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of Butycore^TM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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September 15, 2026: 91��ɫ��Ƶ Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

91��ɫ��Ƶ — Tue, 15 Sep 2026 05:04:35 +0000

91��ɫ��Ƶ Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

91��ɫ��Ƶ was informed of a negative trend during the Committee for Medicinal Products for Human Use (CHMP)’s Oral Explanation meeting which took place on September 14, 2026
Formal CHMP opinion is expected on September 18, 2026
Based on the feedback received following the Oral Explanation, the remaining concerns relate primarily to the attribution of clinical benefit and safety in the absence of a Randomized Control Trial
The Company will provide further updates following the formal CHMP opinion

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Lyon, France, September 15, 2026 – 7:30am CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that it has been informed by the CHMP of the European Medicines Agency (EMA) of a “negative trend” opinion following the Oral Explanation, as part of the re-examination procedure of its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®) for the treatment of aGvHD, following yesterday’s CHMP oral explanation.

“We are deeply disappointed by this outcome. Patients suffering from gastrointestinal-aGvHD continue to face a life-threatening condition with significant unmet medical need and limited treatment options,” said Hervé Affagard, Chief Executive Officer and co-founder of 91��ɫ��Ƶ. “Together with the hematology community, we remain committed to these patients and will evaluate all available options to make this potentially important treatment accessible to patients worldwide.”

Based on the feedback received post Oral Explanation, the CHMP maintained its view that the available clinical data package, primarily in the absence of a randomized control trial, does not allow sufficient characterization of the benefit/risk of MaaT013 (Xervyteg^®).

The Company will provide additional details following the formal CHMP opinion, which is expected to be communicated on September 18, 2026. The Company will assess the implications of the decision and evaluate all available options and will provide an update to the market as appropriate.

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July 6, 2026: 91��ɫ��Ƶ Presents the Results of its Annual General Meeting and Provides a Statement on its Half-Year Liquidity Contract

91��ɫ��Ƶ — Mon, 06 Jul 2026 14:57:57 +0000

91��ɫ��Ƶ Presents the Results of its Annual General Meeting and Provides a Statement on its Half-Year Liquidity Contract

Lyon, France, July 6, 2026 – 6:00 pm CET&�Բ��;– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, presents the results of its Annual and Extraordinary General Meeting held on Tuesday, June 16, 2026 at 9:30 am CET at the Company’s office and broadcasted live (replay available here). The Company also provides an update on the liquidity contract managed by Kepler Cheuvreux as of June 30^th, 2026.

Annual and Extraordinary General Meeting

The quorum reached by the shareholders present, representing, or voting remotely, was above 69.61% of voting shares.

Shareholders overwhelmingly approved most of the resolutions put forward by the Board of Directors by a majority of over 90%. The following resolutions were approved:

Approval of the financial statements for fiscal year 2025;
The renewal of the terms of office for current directors Mr. Jean-Marie Lefèvre, Mrs. Nadia Kamal, Mr. Claude Bertrand, Mr. Hervé Affagard, Mr. Jean Volatier, Seventure Partners and Bpifrance Investissement;
The compensation policy for corporate officers (Chairman, Chief Executive Officer and Directors) and the compensation paid or awarded during 2025 fiscal year – details of the votes on the said resolution is available on the Company’s website here;
Financial resolutions, notably delegations of authority to the Board of Directors to carry out capital increases in various situations.

Only one resolution was rejected:

Delegation of authority to the Board of Directors to decide on any merger, demerger or partial contribution of assets (29th resolution).

In accordance with the approval of resolutions 19 and 20, the Company also announced that the Board of Directors has decided to maintain the liquidity contract signed with Kepler Cheuvreux for the liquidity of the Company’s shares listed on Euronext Paris. Information on this contract is available in the Company’s Universal Registration Document (French only).

The full minutes of the Annual General Meeting and the results of the votes, resolution by resolution are available on the Company’s website in the Investors/ Shareholder Meetings’ section.

Half-year liquidity contract statement

Under the liquidity contract entered into between 91��ɫ��Ƶ and Kepler Cheuvreux, the following resources appeared on the liquidity account on June 30^th, 2026:

– 45,618 shares
– € 66,564.56

– Number of executions on buy side on semester: 2,998

– Number of executions on sell side on semester: 2,808

– Traded volume on buy side on semester: 222,290 shares for € 1,297,309.11

– Traded volume on sell side on semester: 203,219 shares for € 1,268,496.55

As a reminder :

the following resources appeared on the last half-year statement on 31 December 2025 on the liquidity account:
- 26,547 shares
- € 94,695.27
- Number of executions on buy side on semester: 2,120
- Number of executions on sell side on semester: 2,342
- Traded volume on buy side on semester: 74,642 shares for € 332,072.16
- Traded volume on sell side on semester: 83,855 shares for € 394,938.88

the following resources appeared on the liquidity account when the activity started:
- 0 shares
- € 200,000.00

The implementation of this report is carried out in accordance with AMF Decision N°2021-01 of June 22^nd, 2021, renewing the implementation of liquidity contracts for shares as an accepted market practice.

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About 91��ɫ��Ƶ
91��ɫ��Ƶ 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, 91��ɫ��Ƶ is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91��ɫ��Ƶ develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91��ɫ��Ƶ has been listed on Euronext Paris (ticker: MAAT) since 2021.

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July 2nd, 2026: Monthly Information Regarding the Total Number of Voting Rights and Shares Comprising the Share Capital

91��ɫ��Ƶ — Thu, 02 Jul 2026 16:07:29 +0000

Monthly Information Regarding the Total Number of Voting Rights and Shares Comprising the Share Capital

Article 223-16 of the General Regulations of the Financial Markets Authority
(AMF – Autorité des Marchés Financiers)

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Lyon, France, July 2, 2026 – 6:30 pm CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation,��today published the number of shares comprising the share capital and the total number of voting rights (Article L. 233-8 of the French Commercial Code (Code de commerce) and Article 223-16 of the General Regulations of French Autorité des Marchés Financiers (AMF)) on June 30, 2026.

Listing place: Euronext Paris

ISIN code: FR0012634822

Website:

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Date	Total number of shares comprising the share capital	Total number of theoretical voting rights ⁽¹⁾	Total number of effective voting rights ⁽²⁾
06/30/26	18,863,543	18,863,543	18,817,925

��(1) In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended.
(2) Effective voting rights correspond to the total number of voting rights that may be used at a General Meeting. The total number of effective voting rights is calculated without taking into account the shares with suspended voting rights.

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About 91��ɫ��Ƶ
91��ɫ��Ƶ 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, 91��ɫ��Ƶ is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91��ɫ��Ƶ develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91��ɫ��Ƶ has been listed on Euronext Paris (ticker: MAAT) since 2021.

The post July 2nd, 2026: Monthly Information Regarding the Total Number of Voting Rights and Shares Comprising the Share Capital appeared first on 91��ɫ��Ƶ.

June 26, 2026: 91��ɫ��Ƶ Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease

91��ɫ��Ƶ — Fri, 26 Jun 2026 05:15:26 +0000

91��ɫ��Ƶ Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®), confirming the trend communicated in May 2026 after the Oral Explanation
91��ɫ��Ƶ plans to seek re-examination of the opinion and request that a Scientific Advisory Group (SAG) be convened
Second opinion upon re-examination expected during CHMP session in September 2026

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Lyon, France, June 26, 2026 – 7:30 am CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation,��today announced that the CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013, under the brand name Xervyteg®, for the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy. This confirms the previously announced negative trend opinion disclosed on May 20, 2026. The Company has reviewed grounds cited by the CHMP and confirms its plan to seek re-examination of the opinion as previously announced.

Under EMA procedures, the re-examination includes the appointment of a new rapporteur and co-rapporteur who will conduct a new and independent evaluation of the dossier. 91��ɫ��Ƶ will also request a Scientific Advisory Group (SAG) hearing with hematology experts on aGvHD to provide input and insights to the CHMP into, among other things, the clinical reality of managing aGvHD with complex concomitant therapies and patients in high need of solutions due to the severity of the disease and the lack of any other efficient third-line therapy so far.

In its opinion of June 25, 2026, the CHMP maintained the position that, given the use of concomitant therapies to manage aGvHD, the data package, primarily based on the ARES single-arm study, does not allow sufficient attribution of the observed clinical effect and safety to the study treatment alone.

Based on current EMA procedural timelines, a new CHMP opinion is expected within 60 days following validation of the re-examination request, with a second decision anticipated in the CHMP September Session (September 14-17, 2026).

91��ɫ��Ƶ remains confident in the clinical profile of MaaT013 (Xervyteg®), to treat a population with very limited treatment options and poor prognosis. This is supported by data from the ARES study, as well as data from the CHRONOS study () and real-world evidence from its Early Access Program, active in 13 countries, with more than 300 patients treated since 2019. The Company also confirms that the re-examination process has no impact on the ongoing Early Access Program, as of today, and that MaaT013 (Xervyteg®) remains available to eligible patients.

91��ɫ��Ƶ’s strategy also extends beyond MaaT013 (Xervyteg®), supported by the development of MaaT033, an oral microbiome therapy, currently evaluated in a randomized controlled Phase 2 trial for broader prophylactic and outpatient use in hemato-oncology, and by the expansion of its platform into immuno-oncology with the next generation product MaaT034.

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About 91��ɫ��Ƶ
91��ɫ��Ƶ 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, 91��ɫ��Ƶ is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91��ɫ��Ƶ develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91��ɫ��Ƶ has been listed on Euronext Paris (ticker: MAAT) since 2021.

About acute Graft-versus-Host Disease
Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient’s organs, causing inflammation of the skin, liver and/or gastrointestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first-line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered steroid resistant (SR) and other agents can be administered. Currently, ruxolitinib is the standard second-line treatment for steroid-refractory acute graft-versus-host disease. More recently, remestemcel L (rknd) was approved in December 2024 in the United States, specifically for use in the pediatric population as a second-line treatment.

About MaaT013 (Xervyteg®)
91��ɫ��Ƶ’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013 (Xervyteg®) is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (a group of bacterial species known to produce anti-inflammatory metabolites). Xervyteg® (MaaT013) aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce the symptoms of steroid-resistant, gastrointestinal (GI)-aGvHD. Xervyteg® (MaaT013) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The post June 26, 2026: 91��ɫ��Ƶ Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease appeared first on 91��ɫ��Ƶ.

May 26, 2026: 91��ɫ��Ƶ Provides Business Update and Reports Financial Results for the First Quarter 2026

91��ɫ��Ƶ — Tue, 26 May 2026 16:42:35 +0000

91��ɫ��Ƶ Provides Business Update and Reports Financial Results for the First Quarter 2026

MaaT013 (Xervyteg®):
- In May 2026, the Company was informed of a “negative trend” opinion on its Marketing Authorization Application from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), ahead of the expected CHMP formal vote in June; the Company plans to request a re-examination procedure upon the formal opinion
- EBMT 2026 annual congress: 91��ɫ��Ƶ presented data from the pivotal ARES trial of MaaT013 (Xervyteg®) featured in the Presidential Session oral presentation and 3 posters (PHOEBUS, CHRONOS and THRASSA)
Revenues of €0.8 million in the first quarter of 2026 derived from the Early Access Program
As of March 31, 2026, cash and cash equivalents were €18.1 million
Cash runway extension to November 2026

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Lyon, France, May 26, 2026 – 7:00 pm CET��– 91��ɫ��Ƶ (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation,��today provided a business update and reported its cash position as of March 31, 2026.

“During the first quarter of 2026, we continued to execute with financial discipline while supporting the advancement of our clinical and regulatory priorities. The drawdown of EIB Tranche B, combined with ongoing operational optimization, has extended our cash runway into November 2026 supporting the upcoming regulatory steps, including the planned re-examination of the Marketing Authorization Application for MaaT013 (Xervyteg®),” stated Eric Soyer, CFO of 91��ɫ��Ƶ.

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Pipeline highlights

In Hemato-Oncology

Acute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg^®)

In January 2026, 91��ɫ��Ƶ transitioned the Early Access Program in Europe to Clinigen, allowing 91��ɫ��Ƶ to leverage the infrastructure of Clinigen and start expanding patient access. The Company has treated approximately 230+ patients under the Early Access Program in 13 different countries to date, and data from the EAP has been presented at major medical congresses.
In March 2026, during the EBMT 2026 annual congress:
- The final results of the ARES pivotal trial evaluating MaaT013 (Xervyteg^®) in aGvHD were presented during an oral presentation during the presidential symposium at EBMT 2026 Annual Congress on March 23, 2026.
- 91��ɫ��Ƶ‘s strategic partner Clinigen hosted a dedicated Industry Symposium on advancing care for steroid-refractory gastrointestinal aGvHD, in the context of the transition in January 2026 of the EAP program to Clinigen, and the ongoing commercial readiness activities, subject to the marketing approval of MaaT013 (Xervyteg^®).
- The Company also presented results from the CHRONOS study, one of the largest real-world studies including refractory GI-aGvHD patients (n=59) treated with third-line best available treatments other than microbiome-based therapy, and announced publication in April 2026 of those retrospective data in Bone Marrow Transplantation Journal. Results from CHRONOS included 29% 12-month overall survival and 37% Day-28 GI-overall response rate, thus supporting the urgent need for new therapeutic options in this indication.

MaaT013 (Xervyteg^®) Regulatory Plan:
- As a post period event, 91��ɫ��Ƶ announced in May 2026 that during the Oral Explanation with EMA’s CHMP, the Company was informed of a “negative trend” in relation with the upcoming June 2026 CHMP vote. Subject to the formal vote at the June 2026 CHMP meeting, the Company intends to request a re-examination of the application.
- As previously announced, the U.S. development plan remains underway, with no material cash impact, to ensure a potential launch in a timely manner of the future clinical study in the U.S, subject to appropriate funding and regulatory, clinical, and operational readiness.
- Additionally, the Company continues to expand its U.S. footprint through its EAP, with recurring patient requests from leading hospitals such as City of Hope (Duarte- Los Angeles, CA), Massachusetts General Hospital (Boston, MA), the University of Alabama Hospital (Birmingham, AL), Miami Cancer Institute (Miami, FL), Chicago Medical Center (Chicago, IL) and Advocate Lutheran Hospital (Park Ridge, IL).

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Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) – MaaT033

In January 2026, as a post period event, a third routine evaluation was conducted and reconfirmed the favorable safety profile of MaaT033 in this trial. The Phase 2 PHOEBUS trial is ongoing and is potentially pivotal in Europe. Topline results (1-year overall survival) are expected in Q4 2028.
In March 2026, the Company presented a poster of the PHOEBUS Phase 2 trial during the EBMT 2026 annual congress, detailing the design and the favorable safety profile confirmed by the 5 DSMBs assessments since 2025.

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In Immuno-Oncology

MaaT034 – Next-generation drug candidates with co-cultured technology

In 2026, the Company is focusing on GMP batch production and regulatory readiness and targets to initiate a First-in- Human trial in 2027, subject to appropriate funding, with a development strategy that will place a particular focus on the U.S. market.
In January 2026, 91��ɫ��Ƶ 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 was also informed by PICASSO’s academic sponsor that topline results could be expected in H1 2026. However, the timing remains subject to the sponsor’s discretion and the Company has no control over the study results communication timelines. The PICASSO expected data are intended to provide complementary insights only and do not directly impact MaaT034’s development strategy.

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Cash position^[1]��

As of March 31, 2026, total cash and cash equivalents were EUR 18.1 million (as compared to EUR 24.9 million as of December 31, 2025), not including the drawdown in April 2026 of Tranche B (EUR 6 million) of the European Investment Bank (EIB) loan financing.
The Company has taken cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.

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Revenues in Q1 2026¹

91��ɫ��Ƶ reported revenues of EUR 0.8 million for the first quarter of 2026 (reported EAP revenues were EUR 1.1 million for the same period of 2025).
Since January 2026 and the transition to the EAP program to Clinigen, 91��ɫ��Ƶ is now selling the product to Clinigen, which then supplies hospitals in Europe. As a result, revenues generated by the Company are now based on the financial terms of the licensing agreement. Consequently, the net income reported by 91��ɫ��Ƶ in Q1 2026, based on transfer price and royalties, was EUR 0.8 million, and would have been EUR 1.3 million pre-transition.
The slight decrease in reported revenues was therefore mostly attributable to the change in revenue accounting. On a same like-for-like basis, revenues generated by MaaT013 (Xervyteg^®) in Q1 2026 reflected a 19% increase year-over-year, underlining the sustained demand for the product.

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Financial calendar*

June 16, 2026: Annual General Meeting
September 29, 2026: Publication of H1 2026 results
November 16, 2026: Publication of revenues & cash for Q3 2026

*Indicative calendar that may be subject to change. ��

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Availability of the Documents Preparatory to the Annual General Meeting

The Company’s shareholders are invited to attend the Combined General Meeting to be held on Tuesday, June 16, 2026, at 9:30 a.m. at the Company’s offices, 70 avenue Tony Garnier – 69007 Lyon, France.
The preliminary notice of meeting, including the agenda and draft resolutions, was published in the Bulletin des Annonces Légales et Obligatoires (BALO) No. 56 dated May 11, 2026, and the notice of meeting will be published in the legal gazette “Le Tout Lyon” on May 27, 2026.
As of today, all information and documents referred to in Articles R. 22-10-23, R. 225-81 and R. 225-83 of the French Commercial Code are available on the Company’s website: maatpharma.com
In accordance with Articles L. 225-115 and R. 225-83 of the French Commercial Code, the full text of the documents to be presented at the General Meeting will also be made available at the Company’s registered office.
The General Meeting will be broadcast live in full by video, and the connection details will be available on the Company’s website. A replay will be made available no later than seven business days after the General Meeting has been held.

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Upcoming conferences participation*

June 24-25, 2026 – Portzamparc Conference Mid & Small Caps 2026, Paris

*Indicative calendar that may be subject to change.

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[1] unaudited financial results

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