-- MaaT013 (Xervyteg(R)):
-- In September 2026, following the re-examination procedure, the
CHMP maintained its negative opinion on the Conditional Marketing
Authorization Application $(MAA)$ for MaaT013 (Xervyteg(R)).
-- Feedback received through a Type C interaction with the U.S.
Food and Drug Administration (FDA) contributes to the preparation
of PHOENIX as a proposed registrational Phase 3 trial and provides
a framework for finalizing the protocol and progressing U.S.
development activities.
-- MaaT034: CMC-focused pre-Investigational New Drug (IND) meeting with
the U.S. FDA, focused on CMC (Chemistry, Manufacturing and Controls)
activities, scheduled for October 2026.
-- Revenue of EUR1.1 million in H1 2026, compared with EUR2.4 million in
H1 2025, mostly driven by the impact of the Clinigen Licensing Agreement
as of January 1, 2026, while patient demand in the Early Access Program
(EAP) remained globally stable.
-- Cash and cash equivalents of EUR17.1 million as of June 30, 2026.
-- Cash runway now estimated to extend to December 2026 based on the
Company's current operating plan.
-- The Company is exploring financing opportunities from investors and
strategic partnerships
LYON, France--(BUSINESS WIRE)--September 29, 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 announced its half-year financial results for the six-month period ended June 30, 2026, and provided a business update.
"In the first half of 2026, the Company continued to advance its development pipeline.
Following the negative CHMP opinion on MaaT013 (Xervyteg(R) ), we initiated a comprehensive review of our portfolio and operating priorities. The measures implemented extend, based on our current estimates, our cash runway to December 2026, while we continue to actively explore financing and strategic partnership opportunities to support the Company's priority programs" stated Eric Soyer, CFO of 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. As of June 30, 2026 and since 2019, more than 550
authorizations have been given under the Early Access Program in 14
different countries.
-- In March 2026, at the European Society for Blood and Marrow
Transplantation $(EBMT)$ 2026 Annual Meeting, MaaT Pharma presented final
results from the ARES trial evaluating MaaT013 (Xervyteg(R)) in aGvHD.
The Company also presented CHRONOS real-world data, reporting 29%
12-month overall survival and 37% Day-28 GI-ORR in third-line patients
treated with therapies other than microbiome-based treatments. Clinigen
hosted a dedicated symposium on steroid-refractory GI-aGvHD.
-- In April 2026, the CHRONOS study was published in Bone Marrow
Transplantation, a peer-reviewed journal.
-- MaaT013 (Xervyteg(R)) Regulatory Evaluation:
In Europe:
-- In June 2026, MaaT Pharma announced that the CHMP of the European
Medicine Agency (EMA) adopted a negative opinion on the conditional MAA
for MaaT013(Xervyteg(R)) for the treatment of aGvHD in adult patients
with gastrointestinal involvement refractory to prior lines of therapy,
confirming the previously announced negative trend opinion disclosed on
May 20, 2026. At that time, the Company confirmed its plan to seek
re-examination of the opinion.
-- As a post-period event, in September 2026, the Company announced that
the CHMP of the EMA had maintained its negative opinion on the CMA
application for MaaT013 following re-examination. During the application
process, MaaT Pharma proposed conducting a randomized controlled Phase 3
trial versus Best Available Therapy (BAT), named PHOENIX, which is
intended to support potential future regulatory submissions in the U.S.,
Europe and other selected territories, subject to further regulatory
feedback, successful execution and positive results.
In the US and globally:
-- As a post-period event, in September 2026, MaaT Pharma announced
progress in U.S. clinical readiness for PHOENIX, supported by feedback
from a Type C interaction with the FDA and the completion of a
feasibility assessment across major clinical trial sites.
-- Subject to appropriate funding and regulatory clearance, PHOENIX is
intended to be conducted across the U.S., Europe and other regions as a
proposed registrational Phase 3 trial, potentially supporting future
registration submissions subject to successful execution and positive
results.
Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033
-- PHOEBUS is a randomized clinical trial vs placebo evaluating MaaT033 in
patients receiving allo-HSCT. Under the current development plan, the
last patient is expected to be enrolled in the fourth quarter of 2027,
with topline results for one-year overall survival anticipated in the
fourth quarter of 2028.
-- In March 2026, the Company presented a poster at the EBMT 2026 Annual
Meeting.
In Immuno-Oncology
MaaT034 - Next-generation drug candidates with co-cultured technology
-- MaaT034, a microbiome ecosystem therapy, is designed to be a universal
Microbiome combination partner for immunotherapies, improving outcomes in
patients with ICI-refractory solid tumors, including NSCLC and melanoma.
-- As a post-period event, in September 2026, MaaT Pharma announced that a
CMC-focused Pre-IND meeting with the FDA was scheduled for October 2026,
representing the next key regulatory milestone for MaaT034. A
First-in-Human study in solid tumors, including second-line advanced
NSCLC and refractory advanced melanoma, has been designed to determine
the optimal dosing and pre-treatment regimen and generate initial
clinical proof-of-concept data. The study could be initiated in late
2027, subject to appropriate funding and regulatory clearance.
Investigator-sponsored immuno-oncology studies
-- In January 2026, MaaT Pharma announced its participation in IMMUNOLIFE,
an investigator-sponsored Phase 2 study led by Gustave Roussy and
designed to further explore the role of the gut microbiome and
antibiotics in responses to immune checkpoint inhibitors in advanced
NSCLC.
-- The Company has also been informed that topline results from the
academic-sponsored PICASSO study may be available in 2026, subject to the
sponsor's timelines. The expected PICASSO data are intended to provide
complementary insights and are not expected to directly impact MaaT034's
development strategy.
In the context of the CHMP outcome, the Company is conducting a strategic review of its assets, which may result in adjustments to the associated development plans and timelines.
Key Financial Results
Key audited financial results for the first half of 2026 are as follows:
Income Statement
2026.06 2025.06
In thousands of euros (6 months) (6 months)
------------ ------------
Revenue 1 079 2 427
Cost of Goods Sold (105) (790)
Gross Margin 974 1 637
Other Income 2 044 2 494
Sales and distribution costs - (491)
General and administrative costs (2 822) (3 611)
Research and development costs (19 200) (14 778)
Operating Income (loss) (19 004) (14 749)
Financial Income 1 472 87
Financial Expense (800) (422)
---------------------------------- ------------ ------------
Net financial income (expense) 672 (336)
Income (loss) before income tax (18 331) (15 085)
---------------------------------- ------------ ------------
Income tax expense - -
Net Income (loss) for the period (18 331) (15 085)
---------------------------------- ------------ ------------
Prepared in accordance with international accounting standards IFRS
Revenues totaled EUR1.1 million as of June 30, 2026, compared with EUR2.4 million on June 30, 2025. The 55% decrease was mostly driven by the evolution of the EAP revenue model, following the implementation as of January 2026 of the Clinigen Licensing Agreement. Revenues now consist of transfer price and royalties, while the number of EAP patient treatments remained globally stable (-4%). Under the licensing agreement, Sales and Distribution costs were also transferred to Clinigen.
Operating loss was EUR18.3 million in the first half of 2026 compared with EUR15.1 million in the first half of 2025. The EUR3.2 million loss increase was mostly attributable to research and development costs, which progressed from EUR14.8 million in the first half of 2025 to EUR19.2 million in the first half of 2026, consistent with the advancement of the Company's late-stage clinical programs, in particular with the data analysis and regulatory activities for MaaT013 (Xervyteg(R) ) and with the ongoing patient recruitment in the PHOEBUS Phase 2b trial in allogeneic-HSCT with MaaT033.
Income statement for the first half of 2026 also reflects accounting depreciation of certain assets, with the impairment review following the negative European regulatory outcome for the MaaT013 (Xervyteg(R) ) conditional MAA.
Cash Position
As of June 30, 2026, total cash and cash equivalents were EUR17.1 million, compared with EUR24.9 million as of December 31, 2025. In the current context, the Company is conducting a strategic review of its assets while taking cash preservation measures with cash horizon now extended to December 2026 (vs November 2026), based on current operational assumptions.
Over the first half of 2026, net cash utilization was EUR7.8 million. Net cash used in Operating and Investment activities was EUR15.0 million, while cash generated in Net Financing activities was EUR7.2 million and included the EUR6.0 million drawdown of the second tranche of the European Investment Bank loan and EUR2.4 million of project loan from Bpifrance.
The Company has updated its corporate presentation available on its website: www.maatpharma.com/investors and has filed its half-year Financial Report to the AMF (Autorité des Marchés Financiers).
Financial calendar*
-- November 16, 2026: Publication of revenues & cash for Q3 2026
*Indicative calendar that may be subject to change.
---
About MaaT Pharma
MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.
Forward-looking Statements
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "aim", "intend, " "may," "anticipate," "estimate," "plan," "project," "will," "can have, " "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260929202254/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 Communication
+33 6 14 06 45 92
media@maat-pharma.com