Nexbiome Therapeutics

European Microbiome Innovation for Health and Microbiome Therapeutics Innovation Group Announce New Collaboration Agreement Paris, France, September 23, 2024, 2:00 pm CET - The European Microbiome Innovation for Health (EMIH) association today announced an agreement between the Microbiome Therapeutics Innovation Group (MTIG) and EMIH for a collaboration to advance microbiome drug development, explore synergies between international regulators, and convene cross-continental meetings to incorporate the perspectives of a wide-range of drug developers. This new collaboration will incorporate diverse perspectives with the goal of further accelerating microbiome therapeutic product development to expand availability of life-changing and life-saving regulatory approved microbiome therapies to patients. A main priority of the agreement is to harmonize regulatory frameworks from multiple regions to create a more cohesive approach in seeking the necessary policy and regulatory solutions for the issues faced by MT drug developers. “MTIG’s founding principal is to accelerate patients’ access to innovative microbiome therapeutics through our communal efforts,” said Dr. Nikole Kimes, Chairman of MTIG and CEO of Siolta Therapeutics. “The EMIH represents innovative microbiome companies aligned with this core mission, and we look forward to sharing insights with one another to amplify our collective voice and transform the lives of patients on both sides of the Atlantic.” Hervé Affagard, President of EMIH and CEO and co-founder of MaaT Pharma, stated "As leading associations in the microbiome field, we understand that our strength lies in collaboration. By joining forces with MTIG, we will accelerate the development and delivery of microbiome therapies, ensuring that groundbreaking treatments reach those who need them most, swiftly and safely. This partnership embodies our shared commitment to harmonizing regulatory frameworks, and we look forward to working closely with MTIG." EMIH and its members are dedicated to advancing knowledge and fostering the development of bioproductions, diagnostics, and medical devices based on the microbiome for human health. The organization is committed to ensuring equitable access to these innovations by adhering to regulatory frameworks that uphold the highest quality standards, while maintaining an economic balance to support ongoing therapeutic innovation. All pharmaceutical and biotechnology companies seeking regulatory approvals in Europe for microbiome bioproductions, diagnostics, and medical devices are eligible for membership consideration in EMIH. If you are interested in learning more, please contact EMIH here. About The Microbiome Therapeutics Innovation Group The Microbiome Therapeutics Innovation Group (MTIG) is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. MTIG is committed to working with stakeholders who share in our mission and seek tangible policy and regulatory solutions in the emerging microbiome arena. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and enable the field to reach its potential to benefit patients. Today, MTIG is comprised of eleven microbiome therapeutics companies: BiomeSense, Biose Industrie, Freya Biosciences, MaaT Pharma, Microba Life Sciences, Rebiotix Inc., a Ferring Company, Seres Therapeutics, Siolta Therapeutics, and Vedanta Biosciences. For more information, visit www.microbiometig.org About European Microbiome Innovation for Health The European Microbiome Innovation for Health (EMIH) is an independent coalition within the European Union, the United Kingdom, and Switzerland, currently comprising 20+ major players from the public and private sectors. From the laboratory to the patient’s bedside, EMIH covers the entire value chain of the microbiome industry. Its goal is to position Europe as a global leader in the development, production, and commercialization of microbiome-based therapeutic innovations. EMIH members include Bioaster, Biocodex, BioGaia, Biofortis, Biose Industrie, Eligo Bioscience, GMT Science, INRAe, Lallemand Health Solutions, Life Avocats, Enosis Santé, EnteroBiotix, Pelican Health, MaaT Pharma, mbiomics, Microbiotica, Microbiome Foundation, MRM Health, Nexbiome, Novobiome, Seventure Partners and SwipeBiome. For more information, please visit www.europeanmicrobiome.org Contact for European Microbiome Innovation for Health Email: p.richaud@europeanmicrobiome.org Attachment EMIH MTIG PR Final_240923

The Alliance Promotion Microbiote is becoming the European Microbiome Innovation for Health: a major step towards structuring the European microbiome excellence sector Paris - France - May 14, 2024 - The Alliance Promotion Microbiome (APM), a key player dedicated to the development, production, and commercialization of therapeutic innovations based on the microbiome, announces today its expansion across Europe and its rebranding as the European Microbiome Innovation for Health (EMIH) association. This transition marks a pivotal moment in solidifying and advancing Europe's industrial microbiome sector, with the goal of fostering medical innovation and securing a prominent global position for European stakeholders to enhance patients' health by addressing unmet medical needs. Beyond a simple change of name, the aim is to formalize the decision to operate at the European level, recognizing its paramount significance due to its critical capacity to drive positive outcomes in research and development, consequently enhancing public health. This choice is underscored by the escalating global competition and underscores the imperative to address the burgeoning realities within the maturing European landscape. This comes at a pivotal moment when the European Union is structuring and displaying major ambitions in terms of health with structuring texts such as SoHO - to be implemented - and the pharmaceutical package - to be brought to a successful conclusion - not forgetting strategic programs such as EU4Health. Each initiative carries profound implications, shaping the trajectory of leveraging the vast potential of microbiome for the health of patients and the European economy. EMIH is an independent European coalition, a public and private initiative and a non-profit organization aiming to ensure that microbiome-based medical innovations become a public health priority in the European Union. Its members are committed to advancing knowledge and the emergence of therapeutic bioproductions, diagnostics, and medical devices based on the microbiome in the field of human health, ensuring equal access through regulatory frameworks meeting the highest quality standards, while also maintaining economic balance to sustain therapeutic innovation. The EMIH believes that only major action at this level will make it possible to structure a leading microbiome sector in Europe, providing the European ecosystem with a key global position to accelerate the emergence of innovative microbiome-based therapies. Such advancements represent a profound and significant paradigm shift in the approach to healthcare for all. "European microbiome actors distinguish themselves with innovative R&D and their significant roles within the global sector. They are recognized for their pursuit of excellence and hold leadership positions in their respective fields. By uniting our efforts within EMIH, our goal is to bring microbiome medical innovation to one of the most promising sectors and to prioritize it within the European Union's public health agenda. Our ambition is to make these advancements accessible to all patients. Thus, we invite all European entities engaged in microbiome research to submit their applications to join EMIH. Together, let's make microbiome the flagship of European health innovation," states Hervé Affagard, President-elect of EMIH. About European Microbiome Innovation for Health (formerly known as Alliance Promotion Microbiome-APM) EMIH is an independent coalition within the European Union, the United Kingdom, and Switzerland, currently comprising 20 major players from the public and private sectors. From the laboratory to the patient's bedside, EMIH covers the entire value chain of the microbiome industry. Its goal is to position Europe as a global leader in the development, production, and commercialization of microbiome-based therapeutic innovations. EMIH members include Bioaster, Biocodex, Biofortis, Biose Industrie, Cynbiome, Eligo Bioscience, Ferring Pharmaceuticals, GMT Science, INRAE, Lallemand Health Solutions, Lyonbiopôle, Pelican Health, MaaT Pharma, Microbiome Foundation, Polepharma, Medicen Paris Région, Nexbiome, Novobiome, Seventure Partners, and Skyepharma. Contacts for European Microbiome Innovation for Health Media - E-mail: pri@frenchmicrobiome.orgMemberships & Applications - E-mail: contact@frenchmicrobiome.org

Lyon – France, November 9th, 2023 – Alliance Promotion Microbiote (APM), a leading player dedicated to the development, the production, and the commercialization of therapeutic innovations based on the microbiome, is proud to announce three new members. With more than 20 current members, APM today welcomes Ferring Pharmaceuticals, Pelican Health and Polepharma, three major contributors to the development, the production, and the commercialization of microbiome-based therapeutic and diagnostic innovations for patients. Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries. www.ferring.com Pelican Health specializes in precision medicine and offers solutions for studying the intestinal microbiome for diagnostic purposes. However, accessing this microbial information currently relies on complex, invasive, expensive, or unrepresentative methods. This is where Pelican Health comes in with a non-invasive, user-friendly, accurate, cost-effective, and scalable solution. This solution comes in the form of a Class IIa device the size of an ingestible pharmaceutical capsule and capable of multiple sample collections. www.pelican-health.com Polepharma represents the French (bio)pharmaceutical industrial sector. Today, it's Europe's leading industrial cooperation in the field of pharmaceuticals, between areas of excellence and industry stakeholders. Polepharma structures the sector and has been supporting its transformation for 20 years. It currently has more than 445 members in France, representing 26 billion euros in exports and 80,000 jobs in France. France has set the priority of ensuring its health sovereignty. To achieve this, it must regain its European leadership and accelerate the transition of its (bio)pharmaceutical industry. Only collective action will meet these challenges. www.polepharma.com Hervé Affagard, President of Alliance Promotion Microbiote states "We are thrilled to extend a warm welcome to Ferring Pharmaceuticals, Pelican Health, and Polepharma as they join our microbiome-focused association. The diverse profiles of our members reflect our common vision of unlocking the potential of microbiome-based innovations that will play a pivotal role in enhancing global patient health. APM celebrates its continuing growth with pride, welcoming private and public entities that, from our perspective, represent the key to a dynamic and rapidly expanding industry." Dr Philippe Niez, Medical Director of Ferring France/Belgium says "Ferring, alongside its scientific partners, is committed to understanding the human microbiome while harnessing its capability for rehabilitation to help people live better. Furthermore, we are exploring the potential of the gut microbiota to develop innovative approaches for diagnosing, treating, and preventing diseases. So, it was important for Ferring to join APM, engaging in discussions with its members on numerous topics within this field." Thomas Soranzo, CEO and co-founder of Pelican Health adds "We are delighted to join APM, a pioneering association central to the ongoing microbiota revolution, resulting from French scientific research and the emergence of innovative companies. We look forward to collaborating with members and proactively participating in discussions and decisions surrounding the political, regulatory, and economic aspects of the microbiome industry. " Fabien Riolet, CEO of Polepharma adds “For the past 5 years, we’ve organized an annual event focused on translating research and applying the science of microbiome. The microbiome shows great potential in advancing diagnostic and therapeutic products. Unleashing this potential requires collaboration between public and private experts in microbiome research and those involved in pharmaceutical development and manufacturing. Joining APM is a crucial and additional step allowing us to actively contribute to fostering synergy within this dynamic ecosystem". Collectively, APM members are shaping the European ecosystem, accelerating the transition from fundamental research to the market launch of microbiome-based therapeutic innovations (microbiota and bacterial consortia). Their goal is to address significant medical needs and enhance the quality of life for millions of patients. To learn more about APM or our membership opportunities, please visit our website: frenchmicrobiome.org About Alliance Promotion Microbiote Created in 2022, Alliance Promotion Microbiote is an independent, non-profit organization bringing together over 20 major players from the public and private sectors. From bench to bedside, APM covers the entire value chain of the microbiome industry. It aims to position France as a European leader in the development, the production and the commercialization of microbiome-based therapeutic innovations. The members of the Alliance Promotion Microbiote are Bioaster, Biocodex, Biofortis, Biose Industrie, Cynbiome, Eligo Bioscience, EverImmune, Ferring Pharmaceuticals, GMT Science, INRAE, INSERM, Lallemand Health Solutions, Lyonbiopôle Auvergne-Rhône-Alpes, Luxia Scientific, Pelican Health, MaaT Pharma, Polepharma, Medicen Paris Région, Nexbiome, Novobiome, Seventure Partners, Skyepharma and TargEDys. Contact Alliance Promotion MicrobioteE-mail: contact@frenchmicrobiome.orgTel: +33 (0)6 14 06 45 92