LYON, France--(BUSINESS WIRE)--Regulatory News:

法国里昂-（商业信息）-监管新闻：

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, and Skyepharma, a French independent CDMO, expert in providing innovative solutions for bioproduction as well as complex drugs development and manufacturing, today announced that a significant development milestone has been reached with the completion of the facility and the transfer of MaaT Pharma’s Production and Development teams to the new site.

MaaT Pharma（EURONEXT:MaaT-“公司”）是一家临床阶段生物技术公司，也是致力于改善癌症患者生存结果的微生物组生态系统疗法（MET）开发领导者，法国独立CDMO Skyepharma专家为生物生产以及复杂药物开发和制造提供创新解决方案，今天宣布，随着设施的完成以及MaaT Pharma的生产和开发团队转移到新站点，已经达到了一个重要的开发里程碑。

The companies had entered a partnership in February 2022 to build the largest cGMP1 facility, to date, for full ecosystem microbiome therapies in Europe..

这些公司于2022年2月建立了合作伙伴关系，以建立迄今为止最大的cGMP1设施，用于欧洲的全生态系统微生物组治疗。。

“With MaaT013, our lead asset currently in Phase 3, and MaaT033, our second drug candidate, nearing launch in a Phase 2b clinical study, we have reached a major milestone that will be fundamental to securing our market access strategy. This new GMP manufacturing facility is a testament to the continued growth of MaaT Pharma,” stated Hervé Affagard, CEO and co-founder of MaaT Pharma.

MaaT Pharma首席执行官兼联合创始人HervéAffagard说：“我们目前处于第三阶段的主要资产MaaT013和我们的第二个候选药物MaaT033即将在2b期临床研究中推出，我们已经达到了一个重要的里程碑，这对于确保我们的市场准入战略至关重要。设施证明了MaaT Pharma的持续增长。

“Thanks to our strategic partnership with Skyepharma, we have successfully completed the new infrastructure within a year. I also want to take the opportunity to thank the ABL Europe team who have hosted our GMP production since 2016.”.

“感谢我们与Skyepharma的战略合作，我们在一年内成功完成了新的基础设施。我还要借此机会感谢自2016年以来主持GMP生产的ABL欧洲团队。”。

MaaT Pharma, the leading microbiome company in oncology, is one of the few end-to-end microbiome companies that oversees the entire process, including innovative bioprocesses for both donor-derived and co-cultured drug candidates in a GMP environment.

MaaT Pharma是肿瘤学领域领先的微生物组公司，是为数不多的监督整个过程的端到端微生物组公司之一，包括GMP环境中供体来源和共培养候选药物的创新生物过程。

“The on-time completion of our first Skyehub facility is a major achievement for Skyepharma and our partner MaaT Pharma. The whole team is proud to have demonstrated the appropriate agility and expertise to deliver this state-of-the-art building and BioCDMO offering in the challenging 12-month timeframe,” added David Lescuyer, CEO and President of Skyepharma.

“我们第一个Skyehub设施的按时完成是Skyepharma和我们的合作伙伴MaaT Pharma的主要成就。整个团队自豪地展示了适当的敏捷性和专业知识，以提供这种最先进的建筑和BioCDMO在具有挑战性的12个月时间内提供，”Skyepharma首席执行官兼总裁David Lescuyer补充说。

“This reliability is an uncompromising service we want to offer to the biotech partners that are joining us. This is an integral part of the outstanding value accelerator that the Skyehub is providing them.”.

“这种可靠性是我们希望向加入我们的生物技术合作伙伴提供的不妥协的服务，这是Skyehub提供的杰出价值加速器的组成部分。”。

Skyepharma is a recognized expert CDMO, offering solutions and technologies to develop hard-to-make oral solids and addresses the complex challenges faced by its worldwide partners to improve patients’ lives. Backed by its strong and continuous double-digit growth over the past 7 years, Skyepharma has continuously invested to keep its offering ever more innovative and focused on customer experience, and ultimately the patients.

Skyepharma是公认的专家CDMO，提供开发难以制造的口服固体的解决方案和技术，并解决其全球合作伙伴面临的改善患者生活的复杂挑战。在过去7年中强劲而持续的两位数增长的支持下，Skyepharma不断投资，以保持其产品更具创新性，专注于客户体验，最终成为患者。

With the Skyehub Bioproduction® model, Skyepharma can also propose a unique capacity and service offering in the demanding bioproduction area..

通过SkyeHubBioProduction®型号，Skyepharma还可以在苛刻的生物生产领域提供独特的产能和服务。。

The completion of this new infrastructure brings with it positive impacts for the regional and national economy. Overall, the partnership between MaaT Pharma and Skyepharma could lead to the creation of a dozen jobs for specialized workers in the industry over the coming years. These therapies demand advanced manufacturing techniques and procedures and will contribute to the growth of the microbiome sector in France.

这一新基础设施的完成对区域和国民经济产生了积极影响。总体而言，MaaT Pharma与Skyepharma之间的合作关系可能会导致未来几年为该行业的专业工人创造十几个工作岗位。这些疗法需要先进的制造技术和程序，并将有助于法国微生物组部门的发展。

MaaT Pharma and Skyepharma are currently performing quality qualification according to GMP guidelines, with the first production campaign targeted to start in the new plant by the end of Q3 2023..

MaaT Pharma和Skyepharma目前正在根据GMP指南执行质量认证，第一次生产活动的目标是在2023季度末之前在新工厂开始。。

About MaaT Pharma

关于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 launched, in March 2022, an open-label, single arm Phase 3 clinical trial in patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial.

MaaT Pharma是一家临床阶段的生物技术公司，已经建立了恢复肿瘤患者-微生物共生的完整方法。MaaT Pharma致力于治疗癌症和移植物抗宿主病（GvHD），这是异基因干细胞移植的严重并发症，于2022年3月启动了一项针对急性患者的开放标签单臂3期临床试验GvHD，在第二阶段试验中实现其概念验证之后。

Its powerful discovery and analysis platform, gutPrint®, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company’s Microbiome Ecosystem Therapies are produced through a standardized GMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations.

其强大的发现和分析平台gutPrint®能够识别新的疾病目标，评估候选药物，并确定微生物相关病症的生物标志物。该公司的微生物组生态系统疗法是通过标准化的GMP制造和质量控制流程生产的，以安全地提供液体和口服制剂中微生物组的全部多样性。

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)..

MaaT Pharma受益于世界领先科学家的承诺，并与监管机构建立了关系，以支持微生物组疗法在临床实践中的整合。MaaT Pharma在Euronext Paris上市（勾选：MaaT）。。

Forward-looking Statements

前瞻性声明

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.

本新闻稿中包含的关于未来事件的历史事实陈述以外的所有陈述均受（i）未经通知的变更和（ii）超出公司控制范围的因素的约束。这些陈述可以包括但不限于前面的任何陈述，其后或包括诸如「目标」、「相信」、「期望」、「目标」、「意图」、「预期」、「估计」、「计划」、「项目」、「将会」、「可能」、「应该」、「可以」及其他具有相似含义或否定含义的词语及条款。

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..

前瞻性陈述受公司控制之外的固有风险和不确定性的约束，可能导致公司的实际结果或业绩与此类前瞻性陈述所表达或暗示的预期结果或业绩大不相同。。

About Skyepharma

关于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, with a specific expertise and proprietary technologies on modified release products.

SKYEPHARMA是一家独立的法国制药CDMO，100%由其管理团队和Bpifrance拥有。Skyepharma是一家专业的CDMO，专门从事复杂口服固体形式的配制，开发和制造，拥有改性释放产品的专业知识和专有技术。

Skyepharma is based in Saint-Quentin-Fallavier, France. The current factory, dedicated to its activity, occupies 22,000m², on a 60,000m² piece of land. Skyepharma has decided to allocate a portion of the available land to establish its SkyeHub Bioproduction, an innovative model designed to offer clinical and commercial production capacities to biotech companies.

Skyepharma总部设在法国圣昆丁法拉维。目前的工厂致力于其活动，占地60万平方米，占地22000平方米。Skyepharma决定分配一部分可用土地来建立其SkyeHub生物生产，这是一种旨在为生物技术公司提供临床和商业生产能力的创新模式。

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, and other services..

这种SkyeHub模型包括建造专用建筑物，具有专门设计的表面和场所，以及质量，维护，批量发布和其他服务等横向支持服务。。

www.skyepharma.com

www.skyepharma.com

1 GMP: Good Manufacturing Practices is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

1 GMP：良好生产规范是质量保证的一个方面，可确保药品的生产和控制符合其预期用途的质量标准，并符合产品规范的要求。