Press Releases Archives - 91桃色视频 /category/press-releases/ microbiota gut Thu, 30 Jul 2026 14:22:41 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 /wp-content/uploads/2018/10/cropped-logo-maat-pharma-author-32x32.png Press Releases Archives - 91桃色视频 /category/press-releases/ 32 32 July 6, 2026: 91桃色视频 Presents the Results of its Annual General Meeting and Provides a Statement on its Half-Year Liquidity Contract /july-6-2026-maat-pharma-presents-the-results-of-its-annual-general-meeting-and-provides-a-statement-on-its-half-year-liquidity-contract/ Mon, 06 Jul 2026 14:57:57 +0000 /?p=26429 91桃色视频 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 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (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 30th, 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 Lef猫vre, Mrs. Nadia Kamal, Mr. Claude Bertrand, Mr. Herv茅 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鈥檚 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鈥檚 website www.maatpharma.com in the Investors/ Shareholder Meetings鈥 section. Half-year liquidity contract statement Under the liquidity contract entered into between 91桃色视频 and Kepler Cheuvreux, the following resources appeared on the liquidity account on June 30th, 2026: –    45,618 shares–    鈧 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 鈧 1,297,309.11 –   Traded volume on sell side on semester: 203,219 shares for 鈧 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 鈧 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 鈧 332,072.16 Traded volume on sell side on semester: 83,855 shares for 鈧 394,938.88 the following resources appeared on the liquidity account when the activity started: 0 shares 鈧 200,000.00 The implementation of this report is carried out in accordance with AMF Decision N掳2021-01 of June 22nd, 2021, renewing the implementation of liquidity contracts for shares as an accepted market practice. — About 91桃色视频91桃色视频 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桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021. Download the press release

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91桃色视频 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&苍产蝉辫;鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (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 30th, 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 Lef猫vre, Mrs. Nadia Kamal, Mr. Claude Bertrand, Mr. Herv茅 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鈥檚 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鈥檚 website in the Investors/ Shareholder Meetings鈥 section.


Half-year liquidity contract statement

Under the liquidity contract entered into between 91桃色视频 and Kepler Cheuvreux, the following resources appeared on the liquidity account on June 30th, 2026:

–    45,618 shares
–    鈧 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 鈧 1,297,309.11

–   Traded volume on sell side on semester: 203,219 shares for 鈧 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
    • 鈧 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 鈧 332,072.16
    • Traded volume on sell side on semester: 83,855 shares for 鈧 394,938.88
  • the following resources appeared on the liquidity account when the activity started:
    • 0 shares
    • 鈧 200,000.00

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

About 91桃色视频
91桃色视频 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桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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 /july-2nd-2026-monthly-information-regarding-the-total-number-of-voting-rights-and-shares-comprising-the-share-capital/ Thu, 02 Jul 2026 16:07:29 +0000 /?p=26395 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 – Autorit茅 des March茅s Financiers) 听 Lyon, France, July 2, 2026 – 6:30 pm CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听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 Autorit茅 des March茅s Financiers (AMF)) on June 30, 2026. Listing place: Euronext Paris ISIN code: FR0012634822 Website: www.maatpharma.com 听 Date Total number of shares comprising the share capital Total number oftheoretical voting rights (1) Total number of effective voting rights (2) 06/30/26 18,863,543 18,863,543 18,817,925 听(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. — About 91桃色视频91桃色视频 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桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021. Download the press release

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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 – Autorit茅 des March茅s Financiers)

Lyon, France, July 2, 2026 – 6:30 pm CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听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 Autorit茅 des March茅s Financiers (AMF)) on June 30, 2026.

Listing place: Euronext Paris

ISIN code: FR0012634822

Website:

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.

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

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June 26, 2026: 91桃色视频 Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease /june-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/ Fri, 26 Jun 2026 05:15:26 +0000 /?p=26321 91桃色视频 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庐), confirming the trend communicated in May 2026 after the Oral Explanation 91桃色视频 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 Lyon, France, June 26, 2026 – 7:30 am CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听today announced that the CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013, under the brand name Xervyteg庐, 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桃色视频 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桃色视频 remains confident in the clinical profile of MaaT013 (Xervyteg庐), 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 (Clausen et al., 2026) 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庐) remains available to eligible patients. 91桃色视频鈥檚 strategy also extends beyond MaaT013 (Xervyteg庐), 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. — About 91桃色视频 91桃色视频 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桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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鈥檚 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庐) 91桃色视频鈥檚 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庐) 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庐 (MaaT013) aims to restore the symbiotic relationship between the patient鈥檚 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庐 (MaaT013) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 and other words

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91桃色视频 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庐), confirming the trend communicated in May 2026 after the Oral Explanation
  • 91桃色视频 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

Lyon, France, June 26, 2026 – 7:30 am CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听today announced that the CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013, under the brand name Xervyteg庐, 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桃色视频 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桃色视频 remains confident in the clinical profile of MaaT013 (Xervyteg庐), 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庐) remains available to eligible patients.

91桃色视频鈥檚 strategy also extends beyond MaaT013 (Xervyteg庐), 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.

About 91桃色视频
91桃色视频 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桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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鈥檚 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庐)
91桃色视频鈥檚 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庐) 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庐 (MaaT013) aims to restore the symbiotic relationship between the patient鈥檚 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庐 (MaaT013) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

The post June 26, 2026: 91桃色视频 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桃色视频.

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May 26, 2026: 91桃色视频 Provides Business Update and Reports Financial Results for the First Quarter 2026 /may-26-2026-maat-pharma-provides-business-update-and-reports-financial-results-for-the-first-quarter-2026/ Tue, 26 May 2026 16:42:35 +0000 /?p=26178 91桃色视频 Provides Business Update and Reports Financial Results for the First Quarter 2026 MaaT013 (Xervyteg庐): In May 2026, the Company was informed of a 鈥渘egative trend鈥 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桃色视频 presented data from the pivotal ARES trial of MaaT013 (Xervyteg庐) featured in the Presidential Session oral presentation and 3 posters (PHOEBUS, CHRONOS and THRASSA) Revenues of 鈧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 鈧18.1 million Cash runway extension to November 2026 Lyon, France, May 26, 2026 – 7:00 pm CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听today provided a business update and reported its cash position as of March 31, 2026. 鈥淒uring 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庐),鈥 stated Eric Soyer, CFO of 91桃色视频. Pipeline highlights In Hemato-Oncology Acute Graft-versus-Host Disease (aGvHD) 鈥 MaaT013 (Xervyteg庐) In January 2026, 91桃色视频 transitioned the Early Access Program in Europe to Clinigen, allowing 91桃色视频 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庐) in aGvHD were presented during an oral presentation during the presidential symposium at EBMT 2026 Annual Congress on March 23, 2026. 91桃色视频鈥榮 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庐). 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庐) Regulatory Plan: As a post period event, 91桃色视频 announced in May 2026 that during the Oral Explanation with EMA鈥檚 CHMP, the Company was informed of a 鈥渘egative trend鈥 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). 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. 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桃色视频 announced that the first patient was randomized in the IMMUNOLIFE trial evaluating the potential of MaaT033 in combination with Regeneron鈥檚 Cemiplimab in enhancing disease control rate versus best investigator鈥檚 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鈥檚 academic sponsor that topline results could be expected in H1 2026. However, the timing remains subject to the sponsor鈥檚 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鈥檚 development strategy. Cash position[1]听 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. Revenues in Q1 20261 91桃色视频 reported revenues of EUR 0.8 million for the

The post May 26, 2026: 91桃色视频 Provides Business Update and Reports Financial Results for the First Quarter 2026 appeared first on 91桃色视频.

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91桃色视频 Provides Business Update and Reports Financial Results for the First Quarter 2026

  • MaaT013 (Xervyteg庐):
    • In May 2026, the Company was informed of a 鈥渘egative trend鈥 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桃色视频 presented data from the pivotal ARES trial of MaaT013 (Xervyteg庐) featured in the Presidential Session oral presentation and 3 posters (PHOEBUS, CHRONOS and THRASSA)
  • Revenues of 鈧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 鈧18.1 million
  • Cash runway extension to November 2026

Lyon, France, May 26, 2026 – 7:00 pm CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听today provided a business update and reported its cash position as of March 31, 2026.

鈥淒uring 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庐),鈥 stated Eric Soyer, CFO of 91桃色视频.

Pipeline highlights

In Hemato-Oncology

Acute Graft-versus-Host Disease (aGvHD) 鈥 MaaT013 (Xervyteg)

  • In January 2026, 91桃色视频 transitioned the Early Access Program in Europe to Clinigen, allowing 91桃色视频 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桃色视频鈥榮 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桃色视频 announced in May 2026 that during the Oral Explanation with EMA鈥檚 CHMP, the Company was informed of a 鈥渘egative trend鈥 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).

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.

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桃色视频 announced that the first patient was randomized in the IMMUNOLIFE trial evaluating the potential of MaaT033 in combination with Regeneron鈥檚 Cemiplimab in enhancing disease control rate versus best investigator鈥檚 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鈥檚 academic sponsor that topline results could be expected in H1 2026. However, the timing remains subject to the sponsor鈥檚 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鈥檚 development strategy.

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.

Revenues in Q1 20261

  • 91桃色视频 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桃色视频 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桃色视频 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.

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. 听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听

Availability of the Documents Preparatory to the Annual General Meeting

  • The Company鈥檚 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鈥檚 offices, 70 avenue Tony Garnier 鈥 69007 Lyon, France.
  • The preliminary notice of meeting, including the agenda and draft resolutions, was published in the Bulletin des Annonces L茅gales et Obligatoires (BALO) No. 56 dated May 11, 2026, and the notice of meeting will be published in the legal gazette 鈥淟e Tout Lyon鈥 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鈥檚 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鈥檚 registered office.
  • The General Meeting will be broadcast live in full by video, and the connection details will be available on the Company鈥檚 website. A replay will be made available no later than seven business days after the General Meeting has been held.

Upcoming conferences participation*

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

*Indicative calendar that may be subject to change.

[1] unaudited financial results

About 91桃色视频
91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

The post May 26, 2026: 91桃色视频 Provides Business Update and Reports Financial Results for the First Quarter 2026 appeared first on 91桃色视频.

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May 20, 2026: 91桃色视频 Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg庐) in the treatment of acute Graft-versus-Host Disease /may-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/ Wed, 20 May 2026 18:42:29 +0000 /?p=26017 91桃色视频 Announces Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg庐) in the treatment of acute Graft-versus-Host Disease During the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) Oral Explanation, the Company received a 鈥渘egative trend鈥 opinion for the upcoming June CHMP vote Subject to the formal CHMP vote expected in the June Meeting, the Company plans to request a re-examination procedure for the application Lyon, France, May 20, 2026 – 8:45pm CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today it has been informed by the CHMP of the EMA of a 鈥渘egative trend鈥 opinion on its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg庐) for the treatment of acute Graft-versus-Host Disease (aGvHD), following its recent CHMP oral explanation. The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA鈥檚 procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company鈥檚 official request for re-examination. 鈥淲e continue to strongly believe in the potential for registration of MaaT013 (Xervyteg庐). We remain committed to working closely with the EMA to progress this application, encouraged by the therapy鈥檚 potential to address the significant unmet medical need in patients with aGvHD and by the continued support from the hematology community,鈥 said Herv茅 Affagard, CEO and co-founder of 91桃色视频.听鈥淥ur application remains under review, and we are fully committed to engaging constructively in the re-examination process.鈥 For context, the CHMP feedback shared during the Oral Explanation reflects challenges, in the Company鈥檚 view, expected for first-in-class therapies based on a novel therapeutic approach, particularly those based on a single-arm pivotal trial. The application for MaaT013 (Xervyteg庐) is assessed under the Conditional Marketing Authorization (CMA) pathway, which is designed to facilitate earlier access to medicines addressing unmet medical needs while confirmatory data is generated post-approval. The Company is taking 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. MaaT013 (Xervyteg庐) is supported by clinical data from the pivotal ARES study, and real-world data with the ongoing Early Access Program active in 13 countries and with 300+ patients globally treated to date since 2019. Data supporting MaaT013 (Xervyteg庐) has previously been presented at major international congresses and in peer-reviewed publications. The Company remains committed to advancing MaaT013 (Xervyteg庐) through the European regulatory process, expanding patient access and progressing its broader pipeline in microbiome-based in oncology. — About 91桃色视频 91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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鈥檚 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鈥檚 Committee for Human Medicinal Products (CHMP) on March 25, 2022. About Xervyteg庐 (MaaT013) 91桃色视频鈥檚 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听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 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). MaaT013 aims to restore the symbiotic relationship between the patient鈥檚 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). 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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially

The post May 20, 2026: 91桃色视频 Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg庐) in the treatment of acute Graft-versus-Host Disease appeared first on 91桃色视频.

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91桃色视频 Announces Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg庐) in the treatment of acute Graft-versus-Host Disease

  • During the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) Oral Explanation, the Company received a 鈥渘egative trend鈥 opinion for the upcoming June CHMP vote
  • Subject to the formal CHMP vote expected in the June Meeting, the Company plans to request a re-examination procedure for the application

Lyon, France, May 20, 2026 – 8:45pm CET听鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today it has been informed by the CHMP of the EMA of a 鈥渘egative trend鈥 opinion on its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg庐) for the treatment of acute Graft-versus-Host Disease (aGvHD), following its recent CHMP oral explanation.

The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA鈥檚 procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company鈥檚 official request for re-examination.

鈥淲e continue to strongly believe in the potential for registration of MaaT013 (Xervyteg庐). We remain committed to working closely with the EMA to progress this application, encouraged by the therapy鈥檚 potential to address the significant unmet medical need in patients with aGvHD and by the continued support from the hematology community,鈥 said Herv茅 Affagard, CEO and co-founder of 91桃色视频.听Our application remains under review, and we are fully committed to engaging constructively in the re-examination process.鈥

For context, the CHMP feedback shared during the Oral Explanation reflects challenges, in the Company鈥檚 view, expected for first-in-class therapies based on a novel therapeutic approach, particularly those based on a single-arm pivotal trial. The application for MaaT013 (Xervyteg庐) is assessed under the Conditional Marketing Authorization (CMA) pathway, which is designed to facilitate earlier access to medicines addressing unmet medical needs while confirmatory data is generated post-approval.

The Company is taking 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.

MaaT013 (Xervyteg庐) is supported by clinical data from the pivotal ARES study, and real-world data with the ongoing Early Access Program active in 13 countries and with 300+ patients globally treated to date since 2019. Data supporting MaaT013 (Xervyteg庐) has previously been presented at major international congresses and in peer-reviewed publications. The Company remains committed to advancing MaaT013 (Xervyteg庐) through the European regulatory process, expanding patient access and progressing its broader pipeline in microbiome-based in oncology.

About 91桃色视频
91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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鈥檚 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鈥檚 Committee for Human Medicinal Products (CHMP) on March 25, 2022.

About Xervyteg庐 (MaaT013)
91桃色视频鈥檚 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听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 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). MaaT013 aims to restore the symbiotic relationship between the patient鈥檚 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).

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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 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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May 11, 2026: 91桃色视频 to Hold Annual General Meeting on June 16, 2026 /may-11-2026-maat-pharma-to-hold-annual-general-meeting-on-june-16-2026/ Mon, 11 May 2026 15:55:39 +0000 /?p=25931 91桃色视频 to Hold Annual General Meeting on June 16, 2026 Lyon, France, May 11, 2026 – 6:00pm CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, informs its shareholders that the Annual General Meeting (ordinary and extraordinary) will be held on June 16, 2026, at 9:30am CET at the Company鈥檚 headquarter in France located at 70 avenue Tony Garnier, 69007 Lyon and will also be broadcasted live. The notice of meeting, serving as convening notice is published in the Bulletin des annonces l茅gales obligatoires on Monday, 11 May 2026 (www.journal-officiel.gouv.fr/pages/balo), in bulletin no. 56 (reference 2601636). It contains the detailed agenda, the draft resolutions and the main terms and conditions of participation and voting at this meeting. The convening notice will be published in the Journal des annonces l茅gales “Le Tout Lyon” on 27 May 2026. It will also be sent to registered shareholders and made available to institutions holding bearer shares. The documents and information relating to this General Meeting have been and will be, in accordance with the applicable laws and regulations: posted on 91桃色视频’s website (www.maatpharma.com/investors) under the section “Investors/General Meetings/2026”; made available to shareholders at the Company’s registered office at 70 avenue Tony Garnier, 69007 Lyon, France; and sent to shareholders by Uptevia – Service Assembl茅es G茅n茅rales, 90 – 110 Esplanade du G茅n茅ral de Gaulle – 92931 Paris La D茅fense Cedex, on receipt of their request. 听 Further information on this General Meeting, and on how shareholders can vote, is available on 91桃色视频鈥檚 website under the Investors section (“Participating in the General Meeting”).The General Meeting will be broadcast live via a dedicated platform and can be accessed through the link here. A recording of the General Meeting will be made available on the Company鈥檚 website within the timeframe required by applicable regulations. Financial Calendar* 鈥 May 26, 2026: Publication of Q1 2026 revenue and cash position鈥 June 16, 2026: Annual General Meeting鈥 September 15, 2026: Publication of H1 2026 results鈥 November 16, 2026: Publication of Q3 2026 revenue and cash position(*Indicative calendar that may be subject to change.) — About 91桃色视频91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021. Forward-looking StatementsAll 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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. Download the press release

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91桃色视频 to Hold Annual General Meeting on June 16, 2026

Lyon, France, May 11, 2026 – 6:00pm CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, informs its shareholders that the Annual General Meeting (ordinary and extraordinary) will be held on June 16, 2026, at 9:30am CET at the Company鈥檚 headquarter in France located at 70 avenue Tony Garnier, 69007 Lyon and will also be broadcasted live.

The notice of meeting, serving as convening notice is published in the Bulletin des annonces l茅gales obligatoires on Monday, 11 May 2026 (), in bulletin no. 56 (reference 2601636). It contains the detailed agenda, the draft resolutions and the main terms and conditions of participation and voting at this meeting.

The convening notice will be published in the Journal des annonces l茅gales “Le Tout Lyon” on 27 May 2026. It will also be sent to registered shareholders and made available to institutions holding bearer shares.

The documents and information relating to this General Meeting have been and will be, in accordance with the applicable laws and regulations:

  • posted on 91桃色视频’s website (www.maatpharma.com/investors) under the section “Investors/General Meetings/2026”;
  • made available to shareholders at the Company’s registered office at 70 avenue Tony Garnier, 69007 Lyon, France;
  • and sent to shareholders by Uptevia – Service Assembl茅es G茅n茅rales, 90 – 110 Esplanade du G茅n茅ral de Gaulle – 92931 Paris La D茅fense Cedex, on receipt of their request.

Further information on this General Meeting, and on how shareholders can vote, is available on 91桃色视频鈥檚 website under the Investors section (“Participating in the General Meeting”).
The General Meeting will be broadcast live via a dedicated platform and can be accessed through the link . A recording of the General Meeting will be made available on the Company鈥檚 website within the timeframe required by applicable regulations.

Financial Calendar*

鈥 May 26, 2026: Publication of Q1 2026 revenue and cash position
鈥 June 16, 2026: Annual General Meeting
鈥 September 15, 2026: Publication of H1 2026 results
鈥 November 16, 2026: Publication of Q3 2026 revenue and cash position
(*Indicative calendar that may be subject to change.)

About 91桃色视频
91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 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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April 1st, 2026: 91桃色视频 Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal /april-1st-2026-maat-pharma-announces-publication-of-retrospective-data-in-third-line-acute-gvhd-from-the-chronos-study-in-bone-marrow-transplantation-journal-2/ Wed, 01 Apr 2026 05:24:14 +0000 /?p=25353 91桃色视频 Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal CHRONOS is one of the largest real-world听studies听including refractory GI-aGvHD patients听(n=59) treated with third-line best available treatments other than microbiome-based听therapy Results from CHRONOS have been presented at the upcoming EBMT 2026 Annual Congress and included 29% 12-month overall survival (OS) and 37% Day-28 GI-overall response rate (GI-ORR), supporting the urgent need for new therapeutic options CHRONOS results have been included in the MaaT013 (Xervyteg庐) Marketing Authorization Application filed with the European Medicines Agency (EMA) to contextualize the third-line setting for patients suffering from GI-aGvHD and being resistant to prior lines of treatment MaaT013 (Xervyteg庐) Marketing Authorization application is currently under regulatory review by the EMA, with feedback anticipated mid-2026, based on EMA鈥檚 standard timelines Lyon, France, April 1st, 2026 – 7:30am CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the publication of CHRONOS, a large multicenter retrospective cohort study evaluating real-world鈥 outcomes of third-line systemic therapies (excluding microbiotherapy) in 59 patients with steroid- and ruxolitinib-refractory aGvHD with gastrointestinal involvement in the peer鈥憆eviewed journal Bone Marrow Transplantation, the official journal of the European Society for Blood and Marrow Transplantation (EBMT). The article is available here: Clinical outcomes of third-line therapy for aGvHD with gastrointestinal involvement after steroids and ruxolitinib failure. The CHRONOS data have also been presented during a poster session by Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria and primary author of the publication at the 2026 EBMT Annual Congress. CHRONOS is a multicenter real鈥憌orld study offering, to the Company鈥檚 best knowledge, one of the largest and most current real鈥憌orld recent benchmarks of third鈥憀ine systemic treatments (excluding microbiotherapy) in patients with steroid鈥 and ruxolitinib鈥憆efractory aGvHD. The study reports limited durability of response and limited survival benefit with currently available off-label therapeutic options in this high-risk patient population. 91桃色视频 sponsored the CHRONOS study to contextualize the final results of the pivotal ARES trial evaluating MaaT013 (Xervyteg庐), announced in December 2025 and support its Marketing Authorization Application. This multi-center retrospective study provides real-world evidence on patients with steroid- and ruxolitinib-refractory or -intolerant aGvHD for context on how MaaT013 (Xervyteg庐) could potentially support evolving treatment standards in the third-line setting. 鈥淐HRONOS provides a contemporary reference point for third-line GI-aGvHD, underscoring both the gravity of this condition and the persistent lack of standardized, effective therapies. The study highlights the stark limitations of current options and sets a meaningful new benchmark for this challenging clinical setting鈥, said Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria. The CHRONOS study retrospectively evaluated 59 adult patients, treated across 16 European transplant centers in Austria, Belgium, France and Spain, in whom treatment with corticosteroids (first-line) and ruxolitinib (second-line) failed. Most patients presented with a severe form of aGvHD (46% of grade III and 48% of grade IV) and were steroid-resistant (97%) and resistant to ruxolitinib (95%). Twelve different third-line therapies were used, the most frequent being anti-TNF鈥懳 (n=20), extracorporeal photopheresis (n=17) and vedolizumab (n=10). Key findings from CHRONOS study include: GI-overall response rate (ORR) at Day 28 was 37% with 22% GI-complete response (n=13), 10% GI-very good partial response (n=6), and 5% GI-partial response (n=3), and all-organ ORR at Day 28 was 36% Response rates declined by Day 56 with a GI-ORR of 22% and all-organ ORR of 20%, suggesting rapid loss of response 12鈥憁onth overall survival: 29% Median overall survival: 86 days These findings highlight the poor prognosis of patients progressing beyond ruxolitinib, emphasizing the need for novel treatments and the absence of treatment standardization, the heterogeneity and limited benefits of current third-line interventions. Until then, the only multicenter benchmark for patients with steroid-refractory aGvHD following ruxolitinib failure or intolerance included a retrospective analysis conducted across nine U.S. centers between 2016 and 2019, reporting modest outcomes in this high-risk population, with an overall response rate of 36% and a 12-month survival of 15% (Abedin et al. (2021)[1]. CHRONOS (Clausen J. et al., Bone Marrow Transplantation 2026), a more recent multicenter retrospective study reflecting contemporary standards of care, demonstrated incremental improvement in OS, with an overall response rate of 37% and a 12-month survival of 29%. This progression in OS but not in ORR highlights the evolution of clinical practice in this setting and establishes a critical contemporaneous benchmark for regulatory evaluation of the most innovative therapeutic approaches such as MaaT013 (Xervyteg庐), assessed in the ARES registration study. For contextual information, the results from the single-arm pivotal ARES trial were presented at the ASH 2025 Annual Congress and at the EBMT 2026 Annual Congress, and included for reference: GI-ORR at Day 28 occurred in 41/66 patients (62%) and mostly consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients), substantially higher than the 37% GI-ORR reported in CHRONOS All-organ ORR at Day 28 occurred in 42/66 patients (64%) patients and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients) Response maintained at Day 56 with a GI-ORR of 47% and an all-organ ORR of 45% 12 months overall survival: 54% vs 29% reported in CHRONOS Median overall survival not reached, indicating that a majority of patients remained alive beyond the longest follow鈥憉p period, while CHRONOS reported 86 days Full dataset available here. 鈥淎cute GvHD remains a devastating disease with a profound unmet medical need. There is a clear necessity for evidence-based, standardized strategies in the third-line setting. By providing an updated and credible benchmark, CHRONOS offers critical context to interpret the results of the pivotal ARES trial and the potential clinical benefit observed with MaaT013 (Xervyteg庐) in this vulnerable patient population鈥, stated Prof. Florent Malard, MD, PhD, Professor of Hematology at Saint-Antoine Hospital and Sorbonne University, and lead investigator of the ARES trial. Building on these

The post April 1st, 2026: 91桃色视频 Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal appeared first on 91桃色视频.

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91桃色视频 Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal

  • CHRONOS is one of the largest real-world听studies听including refractory GI-aGvHD patients听(n=59) treated with third-line best available treatments other than microbiome-based听therapy
  • Results from CHRONOS have been presented at the upcoming EBMT 2026 Annual Congress and included 29% 12-month overall survival (OS) and 37% Day-28 GI-overall response rate (GI-ORR), supporting the urgent need for new therapeutic options
  • CHRONOS results have been included in the MaaT013 (Xervyteg) Marketing Authorization Application filed with the European Medicines Agency (EMA) to contextualize the third-line setting for patients suffering from GI-aGvHD and being resistant to prior lines of treatment
  • MaaT013 (Xervyteg) Marketing Authorization application is currently under regulatory review by the EMA, with feedback anticipated mid-2026, based on EMA鈥檚 standard timelines

听 听 听 听 听 听

Lyon, France, April 1st, 2026 – 7:30am CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the publication of CHRONOS, a large multicenter retrospective cohort study evaluating real-world鈥 outcomes of third-line systemic therapies (excluding microbiotherapy) in 59 patients with steroid- and ruxolitinib-refractory aGvHD with gastrointestinal involvement in the peer鈥憆eviewed journal Bone Marrow Transplantation, the official journal of the European Society for Blood and Marrow Transplantation (EBMT). The article is available here: . The CHRONOS data have also been presented during a poster session by Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria and primary author of the publication at the 2026 EBMT Annual Congress.

CHRONOS is a multicenter real鈥憌orld study offering, to the Company鈥檚 best knowledge, one of the largest and most current real鈥憌orld recent benchmarks of third鈥憀ine systemic treatments (excluding microbiotherapy) in patients with steroid鈥 and ruxolitinib鈥憆efractory aGvHD. The study reports limited durability of response and limited survival benefit with currently available off-label therapeutic options in this high-risk patient population. 91桃色视频 sponsored the CHRONOS study to contextualize the final results of the pivotal ARES trial evaluating MaaT013 (Xervyteg), announced in December 2025 and support its Marketing Authorization Application. This multi-center retrospective study provides real-world evidence on patients with steroid- and ruxolitinib-refractory or -intolerant aGvHD for context on how MaaT013 (Xervyteg) could potentially support evolving treatment standards in the third-line setting.

鈥淐HRONOS provides a contemporary reference point for third-line GI-aGvHD, underscoring both the gravity of this condition and the persistent lack of standardized, effective therapies. The study highlights the stark limitations of current options and sets a meaningful new benchmark for this challenging clinical setting鈥, said Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria.

The CHRONOS study retrospectively evaluated 59 adult patients, treated across 16 European transplant centers in Austria, Belgium, France and Spain, in whom treatment with corticosteroids (first-line) and ruxolitinib (second-line) failed.

Most patients presented with a severe form of aGvHD (46% of grade III and 48% of grade IV) and were steroid-resistant (97%) and resistant to ruxolitinib (95%). Twelve different third-line therapies were used, the most frequent being anti-TNF鈥懳 (n=20), extracorporeal photopheresis (n=17) and vedolizumab (n=10).

Key findings from CHRONOS study include:

  • GI-overall response rate (ORR) at Day 28 was 37% with 22% GI-complete response (n=13), 10% GI-very good partial response (n=6), and 5% GI-partial response (n=3), and all-organ ORR at Day 28 was 36%
  • Response rates declined by Day 56 with a GI-ORR of 22% and all-organ ORR of 20%, suggesting rapid loss of response
  • 12鈥憁onth overall survival: 29%
  • Median overall survival: 86 days

These findings highlight the poor prognosis of patients progressing beyond ruxolitinib, emphasizing the need for novel treatments and the absence of treatment standardization, the heterogeneity and limited benefits of current third-line interventions.

Until then, the only multicenter benchmark for patients with steroid-refractory aGvHD following ruxolitinib failure or intolerance included a retrospective analysis conducted across nine U.S. centers between 2016 and 2019, reporting modest outcomes in this high-risk population, with an overall response rate of 36% and a 12-month survival of 15% (Abedin et al. (2021)[1]. CHRONOS (Clausen J. et al., Bone Marrow Transplantation 2026), a more recent multicenter retrospective study reflecting contemporary standards of care, demonstrated incremental improvement in OS, with an overall response rate of 37% and a 12-month survival of 29%. This progression in OS but not in ORR highlights the evolution of clinical practice in this setting and establishes a critical contemporaneous benchmark for regulatory evaluation of the most innovative therapeutic approaches such as MaaT013 (Xervyteg), assessed in the ARES registration study.

For contextual information, the results from the single-arm pivotal ARES trial were presented at the ASH 2025 Annual Congress and at the EBMT 2026 Annual Congress, and included for reference:

  • GI-ORR at Day 28 occurred in 41/66 patients (62%) and mostly consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients), substantially higher than the 37% GI-ORR reported in CHRONOS
  • All-organ ORR at Day 28 occurred in 42/66 patients (64%) patients and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients)
  • Response maintained at Day 56 with a GI-ORR of 47% and an all-organ ORR of 45%
  • 12 months overall survival: 54% vs 29% reported in CHRONOS
  • Median overall survival not reached, indicating that a majority of patients remained alive beyond the longest follow鈥憉p period, while CHRONOS reported 86 days

Full dataset available .

鈥淎cute GvHD remains a devastating disease with a profound unmet medical need. There is a clear necessity for evidence-based, standardized strategies in the third-line setting. By providing an updated and credible benchmark, CHRONOS offers critical context to interpret the results of the pivotal ARES trial and the potential clinical benefit observed with MaaT013 (Xervyteg) in this vulnerable patient population鈥, stated Prof. Florent Malard, MD, PhD, Professor of Hematology at Saint-Antoine Hospital and Sorbonne University, and lead investigator of the ARES trial.

Building on these historical benchmarks, the ARES trial demonstrates the potential for MaaT013 (Xervyteg) contingent to EMA鈥檚 approval, to offer improvement in patient outcomes and contribute to the evolving treatment landscape in this high-risk population.

[1] Abedin S, Rashid N, Schroeder M, Romee R, Nauffal M, Alhaj Moustafa M, Kharfan-Dabaja MA, Palmer J, Hogan W, Hefazi M, Larson S, Holtan S, DeFilipp Z, Jayani R, Dholaria B, Pidala J, Khimani F, Grunwald MR, Butler C, Hamadani M. Ruxolitinib resistance or intolerance in steroid-refractory acute graft-versus-host disease – a real-world outcomes analysis. Br J Haematol. 2021 Nov;195(3):429-432. doi: 10.1111/bjh.17700. Epub 2021 Jul 12. PMID: 34254289; PMCID: PMC9293486.

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

About the CHRONOS Study
CHRONOS is a multicenter, retrospective, non鈥慽nterventional cohort study based on real鈥憌orld data collected from medical charts by participating European transplant centers. The study included adult patients (鈮18 years) who underwent allogeneic hematopoietic stem cell transplantation (allo鈥慔SCT) and received third鈥憀ine systemic therapy for acute graft鈥憊ersus鈥慼ost disease (aGvHD) with gastrointestinal involvement between May 30, 2019 and September 30, 2024. Eligible patients presented with MAGIC Grade II鈥揑V GI鈥慳GvHD at treatment initiation and were resistant or dependent on high鈥慸ose corticosteroids and resistant or intolerant to ruxolitinib used as first鈥 and second鈥憀ine therapies. Any third鈥憀ine systemic treatment was permitted, with the exception of fecal microbiotherapy.

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鈥檚 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鈥檚 Committee for Human Medicinal Products (CHMP) on March 25, 2022.

About Xervyteg庐 (MaaT013)
91桃色视频鈥檚 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听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 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). MaaT013 aims to restore the symbiotic relationship between the patient鈥檚 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).

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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 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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March 31, 2026: 91桃色视频 Announces 2025 Annual Results and Provides Business Updates /march-31-2026-maat-pharma-announces-2025-annual-results-and-provides-business-updates/ Tue, 31 Mar 2026 05:30:12 +0000 /?p=25111 91桃色视频 Announces 2025 Annual Results and Provides Business Updates Potential Pivotal Year for MaaT013 (Xervyteg庐): Marketing Authorization Application (MAA) in Europe for MaaT013 (Xervyteg庐) submitted to the European Medicines Agency (EMA) in June 2025 EMA feedback expected mid-2026 per current EMA timelines Commercial readiness continues, with the Clinigen agreement in place and the Early Access Program (EAP) successfully transferred Active discussions ongoing with the Food and Drug Administration (FDA) to assess potential clinical activities with the European regulatory pathway advancing as the primary focus for now EAP Revenues in 2025 of 鈧4.4 million in 2025, a 38% increase over 2024, and the highest revenues generated from the EAP to date Pipeline progress continues: MaaT033, currently in Phase 2b potentially pivotal trial (PHOEBUS), is ongoing and continued to demonstrate a favorable safety profile, with six DSMB reviews completed in 2025. Topline results for PHOEBUS study are now expected in Q4 2028 (instead of Q4 2027) MaaT034 promising preclinical data presented at major scientific conferences 鈧37.5 million financing agreement signed with the European Investment Bank (EIB), structured in four tranches; Tranches A (鈧3.5 million) drawn in October 2025, and Tranche B (鈧6 million) in process As of December 31, 2025, cash and cash equivalents were 鈧24.9 million Cash runway to August 2026, including the upcoming EIB Tranche B funding of 鈧6.0 million Lyon, France, March 31, 2026 鈥 7:30 a.m. CET 鈥 91桃色视频(EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM听(MET) dedicated to enhancing survival for patients with cancer through immune modulation,today reports the 2025 full-year annual results and provides business updates. 鈥2025 was a year of strong clinical momentum for 91桃色视频, marked by major advances across our hemato鈥憃ncology portfolio and progress in immuno鈥憃ncology. In 2026, we are approaching a potentially transformative milestone with the EMA review of MaaT013 (Xervyteg庐), while continuing to expand our oncology platform. We believe 91桃色视频 is well鈥憄ositioned as a leader in microbiome鈥慸riven therapies and we remain focused on advancing our pipeline with the ambition to bring new therapeutic options to patients with high unmet needs, 鈥 stated Herv茅 Affagard, CEO and co-founder of 91桃色视频. Pipeline highlights In Hemato-Oncology 2025 was an important year for 91桃色视频, marked by continued progress for MaaT013 (Xervyteg庐) and steps that reinforced the Company鈥檚 position in microbiome鈥慴ased therapies in hemato鈥憃ncology. Looking ahead, 2026 is expected to be a pivotal year, as MaaT013 (Xervyteg庐) advances through the EMA review process toward a potential first鈥慽n鈥慶lass approval in oncology. The MAA submitted to the EMA is supported by results from the open鈥憀abel, single鈥慳rm pivotal ARES trial, together with a dataset generated through the EAP. As a 鈥渇irst-in-class鈥 potentially setting the foundations for future standards, MaaT013 (Xervyteg庐) is being developed in the field of rare diseases and currently represents the Company鈥檚 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庐) is the most advanced step toward validating the Company鈥檚 oncology platform, which holds scalability potential, notably with MaaT033, an oral form, as the next expansion driver. Acute Graft-versus-Host Disease (aGvHD) 鈥 MaaT013 (Xervyteg庐) In January 2025, the Company announced positive topline results from the pivotal ARES Study evaluating MaaT013 (Xervyteg庐) in aGvHD, meeting its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrating the unprecedented efficacy of MaaT013 (Xervyteg庐) as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD) consistent with communicated EAP results. In March 2025, the Company announced a positive outcome from the final DSMB meeting on ARES trial, confirming the remarkable efficacy results and positive risk/benefit profile of MaaT013 (Xervyteg庐) in third-line GI-aGvHD. In June 2025, the Company announced the submission of a MAA to the EMA for MaaT013, under the registered brand name of MaaT013 (Xervyteg庐). The EMA submission followed the positive opinion from EMA Pediatric Committee received in March 2025 on the Pediatric Investigation Plan for MaaT013 (Xervyteg庐), a key milestone achieved towards the MAA submission to the EMA. In July 2025, the Company signed a license and distribution agreement and commercial supply agreement for MaaT013 (Xervyteg庐) with Clinigen. The Company received an upfront payment of 鈧10.5 million and could receive additional payments of up to 鈧18 million depending on the achievement of pre-specified regulatory and sales milestones, including 鈧12 million upon the Marketing Authorization for MaaT013 (Xervyteg庐) in Europe.听 The Company will also be eligible to receive royalty payments on net sales of a percentage in the mid-thirties and regular cash flow as per the supply agreement. In December 2025, the Company presented the topline results of the ARES pivotal trial evaluating MaaT013 (Xervyteg庐) in aGvHD during the ASH 2025 annual congress and also announced the final results from the pivotal ARES study with a confirmed 1-year overall survival of 54%, confirming durable survival benefit in this high-risk patient population known for extremely poor prognosis. Results have been submitted in a peer-reviewed journal. As a post period event, 91桃色视频 has transitioned the EAP to Clinigen in January 2026. Given Clinigen鈥檚 strength and expertise, this allows the Company to leverage the European infrastructure of Clinigen, in Europe and expand patient access. The Transfer of the EAP to Clinigen also allows to test and validate the supply chain, contributing to the commercial readiness in view of the potential MAA approval of MaaT013 (Xervyteg庐). As a post period event, the final results of the ARES pivotal trial evaluating MaaT013 (Xervyteg庐) in aGvHD were presented during an oral presentation during the presidential symposium at EBMT 2026 Annual Congress on March 23, 2026 and during an oral presentation at the national Congress of the French Hematology Society (SFH) on March 27, 2026. MaaT013 (Xervyteg庐) is currently under review by the EMA. To date, the MAA has progressed in line with the predefined timeline established by the EMA. Based on the status of the procedure, the indicative guidance on review timing

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91桃色视频 Announces 2025 Annual Results and Provides Business Updates

  • Potential Pivotal Year for MaaT013 (Xervyteg):
    • Marketing Authorization Application (MAA) in Europe for MaaT013 (Xervyteg) submitted to the European Medicines Agency (EMA) in June 2025
    • EMA feedback expected mid-2026 per current EMA timelines
    • Commercial readiness continues, with the Clinigen agreement in place and the Early Access Program (EAP) successfully transferred
    • Active discussions ongoing with the Food and Drug Administration (FDA) to assess potential clinical activities with the European regulatory pathway advancing as the primary focus for now
    • EAP Revenues in 2025 of 鈧4.4 million in 2025, a 38% increase over 2024, and the highest revenues generated from the EAP to date
  • Pipeline progress continues:
    • MaaT033, currently in Phase 2b potentially pivotal trial (PHOEBUS), is ongoing and continued to demonstrate a favorable safety profile, with six DSMB reviews completed in 2025. Topline results for PHOEBUS study are now expected in Q4 2028 (instead of Q4 2027)
    • MaaT034 promising preclinical data presented at major scientific conferences
  • 鈧37.5 million financing agreement signed with the European Investment Bank (EIB), structured in four tranches; Tranches A (鈧3.5 million) drawn in October 2025, and Tranche B (鈧6 million) in process
  • As of December 31, 2025, cash and cash equivalents were 鈧24.9 million
  • Cash runway to August 2026, including the upcoming EIB Tranche B funding of 鈧6.0 million

Lyon, France, March 31, 2026 鈥 7:30 a.m. CET 鈥 91桃色视频(EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM听(MET) dedicated to enhancing survival for patients with cancer through immune modulation,today reports the 2025 full-year annual results and provides business updates.

鈥2025 was a year of strong clinical momentum for 91桃色视频, marked by major advances across our hemato鈥憃ncology portfolio and progress in immuno鈥憃ncology. 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 91桃色视频 is well鈥憄ositioned as a leader in microbiome鈥慸riven therapies and we remain focused on advancing our pipeline with the ambition to bring new therapeutic options to patients with high unmet needs, 鈥 stated Herv茅 Affagard, CEO and co-founder of 91桃色视频.

Pipeline highlights

In Hemato-Oncology

2025 was an important year for 91桃色视频, marked by continued progress for MaaT013 (Xervyteg) and steps that reinforced the Company鈥檚 position in microbiome鈥慴ased therapies in hemato鈥憃ncology. Looking ahead, 2026 is expected to be a pivotal year, as MaaT013 (Xervyteg) advances through the EMA review process toward a potential first鈥慽n鈥慶lass approval in oncology. The MAA submitted to the EMA is supported by results from the open鈥憀abel, single鈥慳rm pivotal ARES trial, together with a dataset generated through the EAP. As a 鈥渇irst-in-class鈥 potentially setting the foundations for future standards, MaaT013 (Xervyteg) is being developed in the field of rare diseases and currently represents the Company鈥檚 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鈥檚 oncology platform, which holds scalability potential, notably with MaaT033, an oral form, as the next expansion driver.

Acute Graft-versus-Host Disease (aGvHD) 鈥 MaaT013 (Xervyteg)

  • In January 2025, the Company announced positive topline results from the pivotal ARES Study evaluating MaaT013 (Xervyteg) in aGvHD, meeting its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrating the unprecedented efficacy of MaaT013 (Xervyteg) as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD) consistent with communicated EAP results.
  • In March 2025, the Company announced a positive outcome from the final DSMB meeting on ARES trial, confirming the remarkable efficacy results and positive risk/benefit profile of MaaT013 (Xervyteg) in third-line GI-aGvHD.
  • In June 2025, the Company announced the submission of a MAA to the EMA for MaaT013, under the registered brand name of MaaT013 (Xervyteg). The EMA submission followed the positive opinion from EMA Pediatric Committee received in March 2025 on the Pediatric Investigation Plan for MaaT013 (Xervyteg), a key milestone achieved towards the MAA submission to the EMA.
  • In July 2025, the Company signed a license and distribution agreement and commercial supply agreement for MaaT013 (Xervyteg) with . The Company received an upfront payment of 鈧10.5 million and could receive additional payments of up to 鈧18 million depending on the achievement of pre-specified regulatory and sales milestones, including 鈧12 million upon the Marketing Authorization for MaaT013 (Xervyteg) in Europe.听 The Company will also be eligible to receive royalty payments on net sales of a percentage in the mid-thirties and regular cash flow as per the supply agreement.
  • In December 2025, the Company presented the topline results of the ARES pivotal trial evaluating MaaT013 (Xervyteg) in aGvHD during the ASH 2025 annual congress and also announced the final results from the pivotal ARES study with a confirmed 1-year overall survival of 54%, confirming durable survival benefit in this high-risk patient population known for extremely poor prognosis. Results have been submitted in a peer-reviewed journal.
  • As a post period event, 91桃色视频 has transitioned the EAP to Clinigen in January 2026. Given Clinigen鈥檚 strength and expertise, this allows the Company to leverage the European infrastructure of Clinigen, in Europe and expand patient access. The Transfer of the EAP to Clinigen also allows to test and validate the supply chain, contributing to the commercial readiness in view of the potential MAA approval of MaaT013 (Xervyteg).
  • As a post period event, 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 and during an oral presentation at the national Congress of the French Hematology Society (SFH) on March 27, 2026.
  • MaaT013 (Xervyteg) is currently under review by the EMA. To date, the MAA has progressed in line with the predefined timeline established by the EMA. Based on the status of the procedure, the indicative guidance on review timing remains current. As the review process progresses toward the next phase, the Company will continue to assess ongoing regulatory feedback that may influence the timing and remains proactively engaged in all potential regulatory interactions to ensure appropriate preparation for the next steps of the EMA review.
  • As part of its U.S. market access strategy, the Company continues to evaluate regulatory pathways that could support a future FDA submission, in line with FDA expectations for innovative therapies in aGvHD. Interactions with the FDA remain active as the Company refines the most appropriate clinical study design and timelines for the U.S. With European regulatory progress underway, and with the Company currently prioritizing efforts in Europe, the U.S. market remains the next major step in its global development strategy. As a result, the initiation of a U.S. study, previously anticipated for 2026, could now be expected after the outcome of the Company鈥檚 ongoing MAA review with the EMA. Readiness activities are underway, with no significant cash impact, to ensure a potential launch in a timely manner of the future clinical study in the U.S, pending appropriate funding.
  • Additionally, the Company continues to expand its U.S. footprint through its EAP, with recurring patient requests now coming from six leading hospitals: 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).

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

  • MaaT033, as an oral microbiotherapy based on the same drug substance as MaaT013(Xervyteg庐), holds the potential for value鈥慶reation by enabling broad ambulatory use and expanding the addressable patient population through a prophylactic approach. As the first oral asset of the platform, MaaT033 indicates the Company鈥檚 industrial scalability and further supports its long鈥憈erm growth potential. MaaT033 builds on the pharmaceutical, clinical, and regulatory groundwork conducted with MaaT013 (Xervyteg庐), on which the Company intends to rely for its development.
  • In 2025, four DSMB safety assessments were conducted for MaaT033 in the Phase 2b PHOEBUS randomized trial designed to be pivotal: two routine evaluations and two interim analyses focused on excess mortality. All confirmed a favorable safety profile and recommended continuation of the trial without modifications. 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 Company has strategically prioritized resources on the development of MaaT013 (Xervyteg) in Europe in aGvHD. This focus impacts the timeline of the Phase 2 PHOEBUS trial with the last patient enrollment now anticipated in Q4 2027 (compared to mid-2026 as previously announced). Consequently, topline results (1-year overall survival) are now expected in Q4 2028 (compared to Q4 2027).

In Immuno-Oncology

Leveraging the learnings of the MET鈥慛 platform in hemato-oncology, the MET鈥慍 platform represents a major mid鈥憈erm inflection point for the Company. The Company has strengthened its platform with an enhanced co鈥慶ultivation manufacturing process and AI鈥慹nabled candidate design capabilities. Consistent with the Company鈥檚 stage鈥慻ate strategy, MaaT034 is being developed as the first drug candidate in the immuno鈥憃ncology portfolio.

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

  • In 2025, the Company presented new preclinical data for MaaT034, its next-generation product, at the American Association for Cancer Research (AACR) Annual Meeting and at the Society for Immunotherapies of Cancer (SITC) Annual Meeting, showing compelling anti-tumor efficacy results in germ-free mice.

Key results indicated that:

  • Metagenomic analysis shows that MaaT034 reproduces the microbial functions of MaaT013 (Xervyteg), improves DC-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade听in vitro.
  • MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphila bacteria).

Since 2022, the Company has implemented an exploratory strategy through two investigator鈥憇ponsored trials (IMMUNOLIFE sponsored by Gustave Roussy, and PICASSO, sponsored by AP-HP) using its donor鈥慸erived MET鈥慛 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, 91桃色视频 announced that the first patient was randomized in the IMMUNOLIFE trial evaluating the potential of MaaT033 in combination with Regeneron鈥檚 Cemiplimab in enhancing disease control rate versus best investigator鈥檚 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鈥檚 academic sponsor that topline results would not be available in Q4 2025 (as previously announced) and could now be expected in H1 2026.

  • As the Company prioritized resources on its most late-stage assets, the Company is now focusing for MaaT034 in 2026 on GMP batches production and regulatory readiness and targets a First-in- Human trial start in 2027 (previously 2026), subject to appropriate funding, with a development strategy that will place a particular focus on the U.S. market.

Company Updates

  • In 2025, 91桃色视频 strengthened its manufacturing position by advancing from clinical stage production toward commercial grade readiness. The Company advanced its supply chain for future commercial phase and in the context of the EAP transition to Clinigen. This positions the Company to support potential market entry for MaaT013 (Xervyteg), contingent to EMA approval, and to sustainably support the growth of its broader oncology platform, including MaaT033 and MaaT034.
  • In 2025, the Company announced that Jean-Marie Lef猫vre, Chairman of the Board of Directors of Biocodex, resumes his role as Chairman of the Board of 91桃色视频, following Karim Dabbagh鈥檚 two-year tenure. Additionally, Doroth茅e Burkel, who served as an independent director since 2021, resigned from her position effective December 31, 2025, citing personal reasons.听 The Board of Directors of the Company would like to thank Mrs. Burkel for her contribution to the Board throughout her time in office.
  • In 2025, 91桃色视频 strengthened its scientific leadership with the appointment of Dr. Sheri Simmons as Acting Chief Scientific Officer. Based in the U.S., she brings deep biotechnology and microbiome expertise from senior roles at Seres Therapeutics, Johnson & Johnson, and Seed Health. Sheri now oversees preclinical research and AI/data initiatives and supports the Company鈥檚 efforts toward the Marketing Authorization of MaaT013 (Xervyteg) in aGvHD. This appointment further reinforces a balanced organization combining long鈥憇tanding expertise with newly added downstream capabilities.
  • In 2025, the Company鈥檚 shareholding structure evolved, with both liquidity and free float significantly increasing from the second half of 2025, also driven by the inclusion of 91桃色视频 in the CAC Small, CAC Mid & Small, and CAC All-Tradable indices. The free float now represents 29.8% of the share capital, reflecting a broader and more diversified investor base.

Financial highlights
The key financial audited results for the full year of 2025 are as follows.

Condensed Income Statement

In thousands of euros

31 December 2025

(12 months)

31 December 2024

(12 months)

Revenue4 5243 216
Other Income4 4213 831
Sales, General and Administrative costs(8 220)(6 923)
Research and Development costs(29 054)(27 302)
Operating income (expense)(29 729)(28 428)
Financial Income227401
Financial Expense(1 560)(878)
Net financial income (expense)(1 332)(477)
Net Income (loss) for the period(31 061)(28 904)
In accordance with IFRS international standards. Detailed financial information available here (French only) – The audit procedures for the 2025 financial statements were carried out by the Company’s statutory auditors and the 2025 statutory accounts were closed by the Company’s Board of Directors on March 25, 2026. The financial statements are available on the Company’s website. The full financial reports will be included in the Company’s Universal Registration Report (equivalent to the annual financial report), which will be filed with the Autorit茅 des March茅s Financiers on 31 March 2026.

Revenues totaled 鈧4.5 million for the year ended December 31, 2025, mostly comprised of compensation invoiced from the Early Access Program in France: 鈧4.4 million EAP revenues in 2025, vs 鈧3.2 million in 2024, a 鈧1.2 million/38% increase year-over-year reflecting a growing adoption in the hemato-oncology medical community.

Other income of 鈧4.4 million included R&D tax credits of 鈧3.8 million in 2025, from 鈧3.5 million in the prior year, and grants of 鈧0.4 million in 2025, from 鈧0.1 million in the prior year.

Research and Development expenses were 鈧29.1 million in 2025, an increase of 鈧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 鈧8.2 million in 2025, compared with 鈧6.9 million in 2024. The 鈧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 鈧29.7 million in 2025 compared with 鈧28.4 million for 2024, an increase of 鈧1.3 million.

Net loss was 鈧31.1 million for the year ended December 31, 2025, compared with 鈧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 鈧24.9 million, as compared to 鈧20.2 million as of December 31, 2024.

The net increase in cash position of 鈧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 鈧16.0 million, while cash generated in financial activities was 鈧20.7 million, including 鈧20.8 million in net equity capital raises and 鈧3.2 million from new loans, while loan repayments and interests amounted to 鈧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庐 (MaaT013): a milestone payment of 鈧12 million from Clinigen upon obtaining the Marketing Authorization, and the drawdown of Tranche C of the EIB loan for 鈧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*

  • May 15, 2026: Publication of revenues & cash for Q1 2026
  • June 16, 2026: Annual General Meeting
  • September 15, 2026: Publication of H1 results
  • November 16, 2026: Publication of revenues & cash for Q3 2026

*Indicative calendar that may be subject to change.

Upcoming conferences participation

  • April 8-9, 2026 鈥 Investor Access Event, Paris
  • April 15-16, 2026 鈥 Kempen Life Sciences Conference, Amsterdam
  • June 22-25, 2026 – Bio International Convention, San Diego, CA
  • June 24-25, 2026 鈥 Portzamparc Conference Mid & Small Caps 2026, Paris

About 91桃色视频
91桃色视频 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桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

The post March 31, 2026: 91桃色视频 Announces 2025 Annual Results and Provides Business Updates appeared first on 91桃色视频.

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March 23, 2026: 91桃色视频 Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation /march-23-2026-maat-pharma-presents-the-ares-phase-3-pivotal-trial-final-data-during-the-presidential-plenary-session-at-the-52nd-annual-meeting-of-the-european-society-for-bone-and-marrow-transplant/ Mon, 23 Mar 2026 13:56:37 +0000 /?p=25019 91桃色视频 Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation Lyon, France, March 23rd, 2026 – 6:00pm CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Florent Malard, MD, PhD, hematology professor at Saint鈥慉ntoine Hospital and Sorbonne University, presented the final results from the Phase 3 ARES single鈥慳rm pivotal trial evaluating MaaT013 in acute Graft鈥憊ersus鈥慔ost Disease (aGvHD). The presentation took place during the Presidential Plenary Session at the 2026 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Madrid, Spain. MaaT013 is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025, with a decision expected mid-2026, as previously disclosed. Professor Malard emphasized that 鈥済astrointestinal acute GvHD remains a profoundly devastating condition, associated with dismal outcomes. The response rates observed in the ARES trial鈥62% GI-ORR at Day 28, sustained at 47% at Day 56 and 44% at Month 3鈥攖ogether with a 54% one-year overall survival, strongly suggest that this therapeutic approach may provide a clinically meaningful benefit for these patients.鈥 The final efficacy results from the ARES study, previously disclosed in December 2025, are summarized below. The ARES trial is a single-arm, open-label trial evaluating MaaT013 as third-line treatment in 66 adult patients with severe GI-aGvHD refractory to corticosteroids and ruxolitinib across 50 sites in six European countries: Patient profile: 91% (n=60) presented with Grade III鈥揑V aGvHD with GI involvement 86% (n=57) were steroid-resistant and 14% (n=9) steroid-dependent; all were refractory to ruxolitinib Male: 53%, Female: 47% Final Efficacy Outcomes: GI-ORR at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients). All-organ ORR at Day 28 occurred in 42/66 patients (64%) and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients). GI-ORR at Day 56 was maintained at 47% (31/ 66 patients) and prevalently consisted of CR (35%, 23/66 patients). All-organ ORR at Day 56 was 45% (30/66 patients) and prevalently consisted of CR (35%, 23/66 patients). GI-ORR and all-organ ORR at 3 months were both 44% (29/ 66 patients), with a prevalence of CR (36%, 24/66 patients). A durable response was observed, with an estimated cumulative incidence of loss of response at 12 months of 20% (95% CI: 9 to 33) for GI. For all-organs, the estimated cumulative incidence of loss of response at 6 months was 26% (95% CI: 14 to 40). Overall survival (OS) at 12 months was 54%. Median overall survival was not reached, indicating that more than half of the patients were still alive at the end of the study. This suggests a durable survival benefit and reinforces the strong efficacy signal observed in the pivotal ARES study. The median OS of Day 28 responders was not reached, while it was only 54 days for Day 28 non-responders. The OS was significantly higher in patients who had a GI response at Day 28 than those who did not respond: 68% vs 28% respectively (p <0.0001) at 1 year, suggesting a strong association between early GI response and improved survival in refractory GI-aGvHD. A Data and Safety Monitoring Board (DSMB) provided ongoing safety oversight throughout the study. The final DSMB review conducted in March 2025 reported that 鈥渢he study results show an acceptable safety profile and a favorable benefit /risk ratio鈥. The ARES trial results have been submitted to a peer-review leading medical journal for potential publication and will also be presented during an oral presentation by Professor Malard on March 27, 2026, during the annual congress of the French Society of Hematology in Paris. In addition to the oral presentation, 91桃色视频 presents three poster communications, during the EBMT Congress: PHOEBUS Title: MaaT033 for Gut Microbiota Optimization To Improve Survival after Allogeneic HCT: the Phoebus Trial Abstract number: A093 Session: Transplant and Cellular Therapies – Clinical Session Date/Time: Monday, March 23, 2026 – 18:00 鈥 19:00 CET Location: VELAZQUEZ Presenter: Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and PHOEBUS Trial lead investigator CHRONOS Title: Key results from CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD Abstract number: B005 Session: Graft-versus-Host Disease – Clinical Session Date/Time: Tuesday, March 24, 2026 – 18:00 鈥 19:00 Location: VELAZQUEZ Presenter: Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria THRASSA Title: THRASSA, a Multicenter Open-label Study Evaluating the Safety, Tolerability and Efficacy of MaaT013 in Ruxolitinib-Refractory or Intolerant Paediatric/Adolescent Participants with Gastrointestinal Acute Graft-versus-Host Disease Abstract number: P222 Session: Paediatrics – Clinical Session Date/Time: Sunday, March 22, 08:30 鈥 18:00 CET Location: e-Poster area Presenter: Marion Bruelle, Clinical Scientist at 91桃色视频 — About 91桃色视频 91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021. About MaaT013 (Xervyteg庐) 91桃色视频鈥檚 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听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem TherapyTM for acute,

The post March 23, 2026: 91桃色视频 Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation appeared first on 91桃色视频.

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91桃色视频 Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation

Lyon, France, March 23rd, 2026 – 6:00pm CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Florent Malard, MD, PhD, hematology professor at Saint鈥慉ntoine Hospital and Sorbonne University, presented the final results from the Phase 3 ARES single鈥慳rm pivotal trial evaluating MaaT013 in acute Graft鈥憊ersus鈥慔ost Disease (aGvHD). The presentation took place during the Presidential Plenary Session at the 2026 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Madrid, Spain. MaaT013 is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025, with a decision expected mid-2026, as previously disclosed.

Professor Malard emphasized that 鈥済astrointestinal acute GvHD remains a profoundly devastating condition, associated with dismal outcomes. The response rates observed in the ARES trial鈥62% GI-ORR at Day 28, sustained at 47% at Day 56 and 44% at Month 3鈥攖ogether with a 54% one-year overall survival, strongly suggest that this therapeutic approach may provide a clinically meaningful benefit for these patients.鈥

The final efficacy results from the ARES study, previously disclosed in December 2025, are summarized below.

The ARES trial is a single-arm, open-label trial evaluating MaaT013 as third-line treatment in 66 adult patients with severe GI-aGvHD refractory to corticosteroids and ruxolitinib across 50 sites in six European countries:

Patient profile:

  • 91% (n=60) presented with Grade III鈥揑V aGvHD with GI involvement
  • 86% (n=57) were steroid-resistant and 14% (n=9) steroid-dependent; all were refractory to ruxolitinib
  • Male: 53%, Female: 47%

Final Efficacy Outcomes:

  • GI-ORR at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients).
  • All-organ ORR at Day 28 occurred in 42/66 patients (64%) and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients).
  • GI-ORR at Day 56 was maintained at 47% (31/ 66 patients) and prevalently consisted of CR (35%, 23/66 patients).
  • All-organ ORR at Day 56 was 45% (30/66 patients) and prevalently consisted of CR (35%, 23/66 patients).
  • GI-ORR and all-organ ORR at 3 months were both 44% (29/ 66 patients), with a prevalence of CR (36%, 24/66 patients).
  • A durable response was observed, with an estimated cumulative incidence of loss of response at 12 months of 20% (95% CI: 9 to 33) for GI. For all-organs, the estimated cumulative incidence of loss of response at 6 months was 26% (95% CI: 14 to 40).听听
  • Overall survival (OS) at 12 months was 54%.
  • Median overall survival was not reached, indicating that more than half of the patients were still alive at the end of the study. This suggests a durable survival benefit and reinforces the strong efficacy signal observed in the pivotal ARES study. The median OS of Day 28 responders was not reached, while it was only 54 days for Day 28 non-responders.
  • The OS was significantly higher in patients who had a GI response at Day 28 than those who did not respond: 68% vs 28% respectively (p <0.0001) at 1 year, suggesting a strong association between early GI response and improved survival in refractory GI-aGvHD.
  • A Data and Safety Monitoring Board (DSMB) provided ongoing safety oversight throughout the study. The final DSMB review conducted in March 2025 reported that 鈥渢he study results show an acceptable safety profile and a favorable benefit /risk ratio鈥.

The ARES trial results have been submitted to a peer-review leading medical journal for potential publication and will also be presented during an oral presentation by Professor Malard on March 27, 2026, during the annual congress of the French Society of Hematology in Paris. 听

In addition to the oral presentation, 91桃色视频 presents three poster communications, during the EBMT Congress:

PHOEBUS

CHRONOS

THRASSA

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

About MaaT013 (Xervyteg庐)
91桃色视频鈥檚 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听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 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). MaaT013 aims to restore the symbiotic relationship between the patient鈥檚 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).

About MaaT033
MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy seeking to improve overall survival in patients receiving HSCT and other cellular therapies. Its aim is to seek to optimize microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

The post March 23, 2026: 91桃色视频 Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation appeared first on 91桃色视频.

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March 9, 2026: 91桃色视频 to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management /march-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/ Mon, 09 Mar 2026 17:00:48 +0000 /?p=24683 91桃色视频 to Present Four Abstracts at the52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management Oral presentation during Presidential Plenary Session to feature the final results of the ARES pivotal Phase 3 trial evaluating MaaT013 in acute Graft鈥憊ersus鈥慔ost Disease (aGvHD) with gastrointestinal involvement Poster presentations for: CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD not treated with microbiotherapy PHOEBUS, a Phase 2b trial, potentially pivotal, evaluating MaaT033 seeking to improve survival after allogeneic hematopoietic transplantation (HCT), THRASSA, a multicenter, open鈥憀abel paediatric/adolescent study evaluating MaaT013 in patients with ruxolitinib鈥憆efractory or ruxolitinib鈥慽ntolerant gastrointestinal aGvHD Clinigen, 91桃色视频鈥檚 strategic commercial partner for MaaT013鈥檚 Early Access Program and commercialization in Europe听pending European Medicines Agency (EMA) approval, will host an Industry Symposium on advancing care for steroid-refractory gastrointestinal aGvHD Lyon, France, March 9, 2026 – 6:00pm CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听today announced that clinical data and updates from key programs within its hemato鈥憃ncology pipeline will be presented at the 2026 EBMT Annual Meeting, taking place March 22鈥25, 2026 in Madrid, Spain. An oral presentation, scheduled during the Presidential Plenary Session, will detail the final results, including overall survival data, from the Company鈥檚 lead asset MaaT013, which is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025. In addition, 91桃色视频 will present three poster communications, featuring: Key results from CHRONOS, a multicenter retrospective cohort study describing real鈥憌orld outcomes in third鈥憀ine acute gastrointestinal GvHD, and The study designs of two clinical trials (PHOEBUS and THRASSA – pediatric study announced in March 2025) advancing the Company鈥檚 therapeutic pipeline. With this broad clinical data presentation at the 2026 EBMT Annual Meeting, 91桃色视频 reaffirms its position in hemato鈥憃ncology across the full care continuum of HCT and its commitment to improving outcomes for patients undergoing allogeneic transplantation. During this year鈥檚 Congress, Clinigen, 91桃色视频鈥檚 strategic commercial partner for MaaT013鈥檚 Early Access Program and commercialization in Europe pending EMA approval, will host a dedicated symposium on Advancing Management of Steroid Refractory aGvHD with GI Involvement: From Unmet Need to a Potential Third Line Option. MaaT013 is currently under regulatory review and not yet approved. The symposium will be chaired by Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and Fabio Ciceri, MD, PhD, Associate Professor of Hematology, University Vita-Salute San Raffaele. It will also feature renowned hematology experts such as Zinaida Peric, MD, hematologist University of Rijeka (Croatia); Chair, GvHD Subcommittee, Transplant Complications Working Party, EBMT, Ernst Holler, Professor at University Medical Center Regensburg (Germany) and Jaime Sanz, MD, hematologist and coordinator of the Bone Marrow Transplant Unit at the University Hospital La Fe in Valencia (Spain). The details of the Symposium are below: Title: Advancing Management of Steroid Refractory aGvHD with GI Involvement: From Unmet Need to a Potential Third Line Option Date: Sunday, March 22, 2026 Time: 12:30 鈥 14:00 CET Room: N101鈥102 Professor Malard will also speak at a workshop session dedicated to the Current state of microbiota transplantation in allogeneic HCT, independently from any activities related to the Company, on Monday, March 23, 2026, from 11:00am 鈥 11:20am CET in Velazquez location (W02 Workshop | GVHD beyond immunosuppression – Regulation, repair, and innovation). EBMT abstracts are now available at www.ebmt.org. Details of the 91桃色视频 presentations are as follow: Oral presentation: Title: MaaT013 for Ruxolitinib-Refractory Acute Graft-versus-Host Disease with Gastrointestinal Involvement: Final Results from the ARES Phase III Trial Abstract number: GS2-8 Session: GS2 Presidential Symposium Session Date/Time: Monday, March 23, 2026 – 17:33 鈥 17:42 CET Location: VELAZQUEZ Presenter: Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and ARES Trial lead investigator Poster Presentations: PHOEBUS Title: MaaT033 for Gut Microbiota Optimization To Improve Survival after Allogeneic HCT: the Phoebus Trial Abstract number: A093 Session: Transplant and Cellular Therapies – Clinical Session Date/Time: Monday, March 23, 2026 – 18:00 鈥 19:00 CET Location: VELAZQUEZ Presenter:听 Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and PHOEBUS Trial lead investigator CHRONOS Title: Key results from CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD Abstract number: B005 Session: Graft-versus-Host Disease – Clinical Session Date/Time: Tuesday, March 24, 2026 – 18:00 鈥 19:00 Location: VELAZQUEZ Presenter: Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria THRASSA Title: THRASSA, a Multicenter Open-label Study Evaluating the Safety, Tolerability and Efficacy of MaaT013 in Ruxolitinib-Refractory or Intolerant Paediatric/Adolescent Participants with Gastrointestinal Acute Graft-versus-Host Disease Abstract number: P222 Session: Paediatrics – Clinical Session Date/Time: Sunday, March 22, 08:30 鈥 18:00 CET Location: e-Poster area Presenter: Marion Bruelle, Clinical Scientist at 91桃色视频 — About 91桃色视频91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021. About ClinigenClinigen is a global pharmaceutical services company trusted by over 1,000 pharma and biotech partners. With more than 35 years of experience, we accelerate access to critical medicines at every stage of the product lifecycle. As pathfinders, our team of over 1,100 specialists expertly navigate the complexities of clinical trial supply, early access programs, regulatory services, and long-term commercialisation through both licensed and unlicensed pathways. Operating across five continents, we deliver innovative solutions to over 130 countries each

The post March 9, 2026: 91桃色视频 to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management appeared first on 91桃色视频.

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91桃色视频 to Present Four Abstracts at the
52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management

  • Oral presentation during Presidential Plenary Session to feature the final results of the ARES pivotal Phase 3 trial evaluating MaaT013 in acute Graft鈥憊ersus鈥慔ost Disease (aGvHD) with gastrointestinal involvement
  • Poster presentations for:
    • CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD not treated with microbiotherapy
    • PHOEBUS, a Phase 2b trial, potentially pivotal, evaluating MaaT033 seeking to improve survival after allogeneic hematopoietic transplantation (HCT),
    • THRASSA, a multicenter, open鈥憀abel paediatric/adolescent study evaluating MaaT013 in patients with ruxolitinib鈥憆efractory or ruxolitinib鈥慽ntolerant gastrointestinal aGvHD
  • Clinigen, 91桃色视频鈥檚 strategic commercial partner for MaaT013鈥檚 Early Access Program and commercialization in Europe听pending European Medicines Agency (EMA) approval, will host an Industry Symposium on advancing care for steroid-refractory gastrointestinal aGvHD

Lyon, France, March 9, 2026 – 6:00pm CET 鈥 91桃色视频 (EURONEXT: MAAT 鈥 the 鈥淐ompany鈥), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,听today announced that clinical data and updates from key programs within its hemato鈥憃ncology pipeline will be presented at the 2026 EBMT Annual Meeting, taking place March 22鈥25, 2026 in Madrid, Spain.

An oral presentation, scheduled during the Presidential Plenary Session, will detail the final results, including overall survival data, from the Company鈥檚 lead asset MaaT013, which is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025.

In addition, 91桃色视频 will present three poster communications, featuring:

  • Key results from CHRONOS, a multicenter retrospective cohort study describing real鈥憌orld outcomes in third鈥憀ine acute gastrointestinal GvHD, and
  • The study designs of two clinical trials (PHOEBUS and THRASSA – pediatric study announced in March 2025) advancing the Company鈥檚 therapeutic pipeline.

With this broad clinical data presentation at the 2026 EBMT Annual Meeting, 91桃色视频 reaffirms its position in hemato鈥憃ncology across the full care continuum of HCT and its commitment to improving outcomes for patients undergoing allogeneic transplantation.

During this year鈥檚 Congress, Clinigen, 91桃色视频鈥檚 strategic commercial partner for MaaT013鈥檚 Early Access Program and commercialization in Europe pending EMA approval, will host a dedicated symposium on . MaaT013 is currently under regulatory review and not yet approved.

The symposium will be chaired by Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and Fabio Ciceri, MD, PhD, Associate Professor of Hematology, University Vita-Salute San Raffaele. It will also feature renowned hematology experts such as Zinaida Peric, MD, hematologist University of Rijeka (Croatia); Chair, GvHD Subcommittee, Transplant Complications Working Party, EBMT, Ernst Holler, Professor at University Medical Center Regensburg (Germany) and Jaime Sanz, MD, hematologist and coordinator of the Bone Marrow Transplant Unit at the University Hospital La Fe in Valencia (Spain). The details of the Symposium are below:

  • Title:
  • Date: Sunday, March 22, 2026
  • Time: 12:30 鈥 14:00 CET
  • Room: N101鈥102

Professor Malard will also speak at a workshop session dedicated to the Current state of microbiota transplantation in allogeneic HCT, independently from any activities related to the Company, on Monday, March 23, 2026, from 11:00am 鈥 11:20am CET in Velazquez location (W02 Workshop | GVHD beyond immunosuppression – Regulation, repair, and innovation).

EBMT abstracts are now available at . Details of the 91桃色视频 presentations are as follow:

Oral presentation:

  • Title:
  • Abstract number: GS2-8
  • Session: GS2 Presidential Symposium
  • Session Date/Time: Monday, March 23, 2026 – 17:33 鈥 17:42 CET
  • Location: VELAZQUEZ
  • Presenter: Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and ARES Trial lead investigator

Poster Presentations:

PHOEBUS

  • Title:
  • Abstract number: A093
  • Session: Transplant and Cellular Therapies – Clinical
  • Session Date/Time: Monday, March 23, 2026 – 18:00 鈥 19:00 CET
  • Location: VELAZQUEZ
  • Presenter:听 Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and PHOEBUS Trial lead investigator

CHRONOS

  • Title:
  • Abstract number: B005
  • Session: Graft-versus-Host Disease – Clinical
  • Session Date/Time: Tuesday, March 24, 2026 – 18:00 鈥 19:00
  • Location: VELAZQUEZ
  • Presenter: Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria

THRASSA

  • Title:
  • Abstract number: P222
  • Session: Paediatrics – Clinical
  • Session Date/Time: Sunday, March 22, 08:30 鈥 18:00 CET
  • Location: e-Poster area
  • Presenter: Marion Bruelle, Clinical Scientist at 91桃色视频

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

About Clinigen
Clinigen is a global pharmaceutical services company trusted by over 1,000 pharma and biotech partners. With more than 35 years of experience, we accelerate access to critical medicines at every stage of the product lifecycle. As pathfinders, our team of over 1,100 specialists expertly navigate the complexities of clinical trial supply, early access programs, regulatory services, and long-term commercialisation through both licensed and unlicensed pathways. Operating across five continents, we deliver innovative solutions to over 130 countries each year. Whatever the challenge, we find a way. Explore our services at听

About MaaT013
91桃色视频鈥檚 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听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 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). MaaT013 aims to restore the symbiotic relationship between the patient鈥檚 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).

About MaaT033
MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy seeking to improve overall survival in patients receiving HSCT and other cellular therapies. Its aim is to seek to optimize microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥 鈥渂elieve,鈥 鈥渆xpect,鈥 鈥渁im鈥, 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渁nticipate,鈥 鈥渆stimate,鈥 鈥減lan,鈥 鈥減roject,鈥 鈥渨ill,鈥 鈥渃an have,鈥 鈥渓ikely,鈥 鈥渟hould,鈥 鈥渨ould,鈥 鈥渃ould鈥 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

The post March 9, 2026: 91桃色视频 to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management appeared first on 91桃色视频.

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