MaaT Pharma and Skyepharma Have Entered a Partnership to Establish the First Exclusive Microbiome Ecosystem Therapies cGMP Manufacturing Facility in France

LYON, France & SAINT-QUENTIN-FALLAVIER, France--(BUSINESS WIRE)-- Regulatory News:

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MaaT Pharma (EURONEXT: MAAT - the “Company”), a French clinical-stage biotech (Phase 3) and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer and Skyepharma, a Contract Development and Manufacturing Organization (CDMO) specialized in formulating and manufacturing complex and controlled release drugs, today announced they have entered a partnership agreement to build, to date, France’s largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics. The facility, located near Lyon (Saint-Quentin-Fallavier) will boast an initial area of 1,500 square meters, that could be increased to 3,000 square meters depending on MaaT Pharma’s manufacturing needs. The plant will allow MaaT Pharma to increase its manufacturing capacities ten-fold in order to support clinical and commercial development by 2030. The facility will aim to annually produce several thousand enemas of the Company’s lead candidate (MaaT013) dedicated to Graft-versus-Host disease and several hundreds of thousands capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation.

A designated area will be dedicated to R&D and clinical manufacturing of the MaaT03X range by 2030, using MaaT Pharma’s innovative ecosystem co-fermentation technology to increase response rate in immunotherapy treatments.

“As we enter Phase 3 with our lead product MaaT013, the agreement with Skyepharma will allow us to scale up manufacturing to meet product demands, including commercial launch. We can look forward to expanding our product portfolio for cancer patients with serenity,” commented Hervé Affagard, Co-founder and CEO of MaaT Pharma. “This partnership is fully in line with France’s ambition, as stated in the 2030 innovation plan for health, to become a nation at the forefront of biotherapies and ensure health independence in biomanufacturing. The emerging microbiome industry could open up an opportunity to position France as a leader.”

David Lescuyer, Managing Director of Skyepharma added, “SkyeHub will increase cGMP production capacity for microbiome-based drugs in France. Our partnership acts as a value booster as each company brings its know-how and expertise.”

Under the terms of the agreement, which follows a bilateral letter of intent signed in September 2021 and whose financial conditions remain confidential, MaaT Pharma will have a dedicated facility within SkyeHub Bioproduction and construction will be financed by Skyepharma. It is planned that the production site, expected to be operational in 2023, will host MaaT Pharma’s team and proprietary equipment. In this context, the Lyon-based biotech will retain controlling oversight of the R&D as well as clinical and commercial production of its diverse portfolio of enema and capsule drug candidates. In addition to providing the cGMP building, Skyepharma will also provide its extensive expertise in product quality standards, regulatory affairs, certification, and large-scale production.

This new plant will also allow MaaT Pharma to accelerate the development of MaaT03X, its new generation of drug candidates, using its unique proprietary microbiome ecosystem co-fermentation technology, for which the Company was recently awarded two public grants (Plan France Relance and the 4^th Programme d’Investissements d’Avenir (PIA4)). This new oral class of MET products includes hundreds of species and is tailor-made based on clinical data.

About MaaT Pharma

MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved proof of concept in a Phase II clinical trial in acute GvHD. Our powerful discovery and analysis platform, gutPrint®, supports the development and expansion of our pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.

The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice.

MaaT Pharma is listed on Euronext Paris (ticker: MAAT).

About Skyepharma

Skyepharma is an independent French pharmaceutical CDMO, 100% owned by its management team and Bpifrance. Skyepharma is an expert CDMO specialized in the formulation, development and manufacturing of complex oral solid forms (OSD), with a specific expertise and proprietary technologies on modified release products.

Skyepharma is based in Saint-Quentin-Fallavier, France. The current factory, dedicated to its OSD activity, occupies 22,000m², on a 60,000m² piece of land. Skyepharma has decided to allocate a portion of the available land (more than 20,000m²) to establish its SkyeHub Bioproduction, an innovative model designed to offer clinical and commercial production capacities to biotech companies. This SkyeHub model includes the construction of dedicated buildings, with specifically designed surfaces and premises, together with transverse support services such as quality, maintenance, batch release, etc.

Forward-looking Statements

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

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