Press Release: MaaT Pharma Provides Business Update and Reports Financial Results for the First Quarter 2026

Dow Jones
May 27
   --  MaaT013 (Xervyteg(R)): 
 
          --  In May 2026, the Company was informed of a "negative trend" 
             opinion on its Marketing Authorization Application from the 
             Committee for Medicinal Products for Human Use $(CHMP)$ of the 
             European Medicines Agency $(EMA)$, ahead of the expected CHMP formal 
             vote in June; the Company plans to request a re-examination 
             procedure upon the formal opinion 
 
          --  EBMT 2026 annual congress: MaaT Pharma presented data from the 
             pivotal ARES trial of MaaT013 (Xervyteg(R)) featured in the 
             Presidential Session oral presentation and 3 posters (PHOEBUS, 
             CHRONOS and THRASSA) 
 
 
 
   --  Revenues of EUR0.8 million in the first quarter of 2026 derived from 
      the Early Access Program 
 
   --  As of March 31, 2026, cash and cash equivalents were EUR18.1 million 
 
   --  Cash runway extension to November 2026 
LYON, France--(BUSINESS WIRE)--May 26, 2026-- 

Regulatory News:

MaaT Pharma (EURONEXT: MAAT -- the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies$(TM)$ $(MET)$ dedicated to enhancing survival for patients with cancer through immune modulation, today provided a business update and reported its cash position as of March 31, 2026.

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

Pipeline highlights

In Hemato-Oncology

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

   --  In January 2026, MaaT Pharma transitioned the Early Access Program in 
      Europe to Clinigen, allowing MaaT Pharma 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(R)) in aGvHD were presented during an oral presentation 
             during the presidential symposium at EBMT 2026 Annual Congress on 
             March 23, 2026. 
 
          --  MaaT Pharma's strategic partner Clinigen hosted a dedicated 
             Industry Symposium on advancing care for steroid-refractory 
             gastrointestinal aGvHD, in the context of the transition in 
             January 2026 of the EAP program to Clinigen, and the ongoing 
             commercial readiness activities, subject to the marketing approval 
             of MaaT013 (Xervyteg(R)). 
 
          --  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(R)) Regulatory Plan: 
 
          --  As a post period event, MaaT Pharma announced in May 2026 that 
             during the Oral Explanation with EMA's CHMP, the Company was 
             informed of a "negative trend" in relation with the upcoming June 
             2026 CHMP vote. Subject to the formal vote at the June 2026 CHMP 
             meeting, the Company intends to request a re-examination of the 
             application. 
 
          --  As previously announced, the U.S. development plan remains 
             underway, with no material cash impact, to ensure a potential 
             launch in a timely manner of the future clinical study in the U.S, 
             subject to appropriate funding and regulatory, clinical, and 
             operational readiness. 
 
          --  Additionally, the Company continues to expand its U.S. footprint 
             through its EAP, with recurring patient requests from leading 
             hospitals such as City of Hope (Duarte- Los Angeles, CA), 
             Massachusetts General Hospital (Boston, MA), the University of 
             Alabama Hospital (Birmingham, AL), Miami Cancer Institute (Miami, 
             FL), Chicago Medical Center (Chicago, IL) and Advocate Lutheran 
             Hospital (Park Ridge, IL). 
 
 

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, MaaT Pharma announced that the first patient was 
      randomized in the IMMUNOLIFE trial evaluating the potential of MaaT033 in 
      combination with Regeneron's Cemiplimab in enhancing disease control rate 
      versus best investigator's choice in patients with advanced non-small 
      cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 
      blockade following antibiotic (ATB) exposure and who present ATB-induced 
      gut dysbiosis. The Company was also informed by PICASSO's academic 
      sponsor that topline results could be expected in H1 2026. However, the 
      timing remains subject to the sponsor's discretion and the Company has no 
      control over the study results communication timelines. The PICASSO 
      expected data are intended to provide complementary insights only and do 
      not directly impact MaaT034's development strategy. 

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 2026(1)

   --  MaaT Pharma 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, 
      MaaT Pharma 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 MaaT Pharma 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(R)) 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.

Availability of the Documents Preparatory to the Annual General Meeting

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

Upcoming conferences participation*

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

*Indicative calendar that may be subject to change.

About MaaT Pharma

MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.

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

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "aim", "intend, " "may," "anticipate," "estimate," "plan," "project," "will," "can have, " "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

(_______________________________) (1) unaudited financial results

View source version on businesswire.com: https://www.businesswire.com/news/home/20260526455118/en/

 
    CONTACT:    MaaT Pharma -- Investor Relations 

Eric Soyer

Chief Financial Officer

+33 4 28 29 14 00

invest@maat-pharma.com

MaaT Pharma -- Media Relations

Pauline Richaud

Head of Communications

+33 6 14 06 45 92

media@maat-pharma.com

 
 

(END) Dow Jones Newswires

May 26, 2026 13:00 ET (17:00 GMT)

At the request of the copyright holder, you need to log in to view this content

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10