PRESS RELEASES 2016

Jai Patel appointed as Chief Medical Officer and Roger J. Garceau elected to the Board

New York and Paris, December 9, 2016

Enterome SA a pioneer in the development of pharmaceuticals and diagnostics based on the gut microbiome, is pleased to announce the appointments of Jai Patel, Ph.D. as Chief Medical Officer (CMO), and Roger J. Garceau, MD as Non-executive Director. Drs Patel and Garceau bring significant experience in clinical pharmaceutical development and reinforce Enterome’s leadership team as the Company progresses its lead therapeutic and diagnostic projects, including EB8018 for Crohn’s disease, into and through clinical development.

Dr. Patel joins Enterome with over 25 years’ industry experience and a strong background in international clinical development and regulatory affairs. He was most recently Chief Medical & Scientific Officer at NephroGenex, Inc. and, before that, spent over 20 years at GlaxoSmithKline where he held positions of increasing responsibility, serving as Vice President across R&D disciplines including clinical research, medical affairs and global regulatory affairs. He received his medical training at the University of London and is a member of the UK Royal College of Physicians.

Dr. Garceau brings over 30 years’ of pharmaceutical development experience to Enterome. He previously served as CMO and Executive Vice President of Research & Development at NPS Pharmaceuticals, Inc. Prior to this, he held executive clinical and development roles at Sanofi-Aventis, Aventis and Pharmacia-Upjohn (Pfizer), where he contributed to a number of successful new pharmaceutical marketing applications. Dr. Garceau received his Doctorate of Medicine from the University of Massachusetts Medical School.

Commenting on his appointment, Jai Patel said: “I am pleased to join Enterome at such an important time for the Company. Enterome’s unique metagenomics platform has enabled a new way of understanding the gut microbiome and its importance in human health. This platform is identifying novel targets and biomarkers to improve the diagnosis and management of serious diseases. Enterome’s lead therapeutic candidate, EB8018, a novel small molecule candidate with a unique mode of action, in particular, is at an exciting stage of development as it approaches clinical trials as a potential new treatment for Crohn disease. The company is also building a pipeline of products with significant potential and I’m very excited to be working with the exceptional team to discover, develop and advance these in the coming years.”

“Enterome has been expanding rapidly in recent months and continues to make steady progress advancing our pipeline. The appointments of Drs Patel and Garceau, in conjunction with the recent addition of Christophe Bonny as Chief Scientific Officer, significantly enhance the discovery and development, and international corporate development capabilities of the team, and give us great confidence for the further development of the company,” added Pierre Belichard, CEO of Enterome.

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Paris, France and Cambridge, MA, USA – September 19, 2016

Enterome Bioscience SA (“Enterome”), a pioneer in the development of pharmaceuticals and diagnostics based on the gut microbiome, is pleased to announce that it has appointed Christophe Bonny, Ph.D. as Chief Scientific Officer (CSO). Dr. Bonny, will be responsible for developing and advancing Enterome’s R&D strategy focused on the identification of novel targets derived from the microbiome, and the development of molecules secreted by the gut microbiome that mediate interactions with the host – and not mixtures of bacterial strains – as potential new therapeutics.

Dr. Bonny joins Enterome with 20 years’ of medical research and industry experience with a strong background in drug discovery and pre-clinical development in the areas of inflammatory diseases and oncology. He was previously CSO at Bicycle Therapeutics in the UK and before that he worked at Switzerland-based Xigen where he served as CSO and President. Prior to Xigen, Dr. Bonny was Head of Research of the Medical Genetics Unit at the University Hospital of Lausanne, Switzerland. He obtained a Ph.D. in molecular biology from the University of Neuchâtel, Switzerland, and completed a business and entrepreneurship program at Babson College, US. Dr. Bonny is an author on over 100 scientific publications and is an inventor on multiple patents.

“Enterome has an exceptional opportunity to become a leading company developing innovative drugs and diagnostics based on its unrivalled understanding of the microbiome. In just a short time, Enterome has shown the power of its technology and is advancing its lead product, EB8018, which acts on a novel target in Crohn’s Disease. I am excited to join the Company at a time of significant momentum and I look forward to working to further develop and advance Enterome’s pipeline based on its world-class technologies and capabilities,” said Christophe Bonny, Ph.D.

“At Enterome, we are taking a radically different approach from other microbiome companies to pin down well-defined novel targets and develop small molecules and diagnostic products based on our technology platform. We are very pleased to welcome Dr. Bonny to Enterome and l am sure he will make an important contribution as we look to build a pipeline of novel therapeutic products based on our ‘drugs from bugs’ approach,” said Pierre Belichard, CEO of Enterome. “Enterome is at an important inflexion point as we look to leverage our technology, knowledge and industry partnerships to become one of the leading microbiome companies globally.”

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New York and Paris, November 16, 2016

Bristol-Myers Squibb (NYSE: BMY) and Enterome SA (Enterome), a pioneer in the development of pharmaceuticals and diagnostics based on the gut microbiome, announced that they have entered into an Immuno-Oncology focused collaboration agreement for the discovery and development of microbiome-derived biomarkers, drug targets and bioactive molecules to be developed as potential companion diagnostics and therapeutics for cancer. Additionally, the collaboration will seek to identify novel microbiome-derived biomarkers in an effort to improve clinical outcomes for patients treated with Bristol-Myers Squibb’s Immuno-Oncology portfolio.

The collaboration will combine Bristol-Myers Squibb’s expertise in the discovery and development of novel immunotherapies with Enterome’s proprietary metagenomic technology platform and leadership in the rapidly advancing science of the gut microbiome to support the discovery of novel immunotherapy agents and biomarkers. There is a growing body of scientific evidence to suggest that the gut microbiome plays an important role in modulating mechanisms of response and resistance to cancer immunotherapies. Changes in a host’s immune system driven by the gut microbiome can be exploited to identify specific targets and bioactive compounds with the potential to augment anti-cancer immune responses.

“We continue to pursue the full potential of Immuno-Oncology by applying rapidly evolving science, technology and research to our strong foundation in harnessing the immune system to fight cancer,” said Carl Decicco, Ph. D., head of discovery at Bristol-Myers Squibb. “Business development has been integral in partnering external innovation with our internal R&D expertise and capabilities. Enterome’s focus on target identification and validation along with their significant experience in microbiome research can help to advance our goal to improve outcomes for patients treated with immunotherapies.”

“We are delighted to collaborate with Bristol-Myers Squibb to help advance the field of Immuno-Oncology,” said Pierre Belichard, chief executive officer at Enterome. “The exciting combination of Bristol-Myers Squibb’s extensive capabilities in Immuno-Oncology with our expertise in identifying novel targets and molecules derived from the gut microbiome is highly complementary, and offers a unique opportunity to develop a new generation of cancer drugs and diagnostics.”

Under the terms of the agreement, Bristol-Myers Squibb will be granted exclusive rights to intellectual property and therapies generated during the collaboration. Enterome will receive an upfront payment of $15 million for access to its technology plus R&D funding. Enterome is also eligible to receive preclinical and clinical milestone payments for each licensed therapeutic candidate plus royalties on net sales. Enterome is eligible for additional milestone payments in relation to new diagnostic products discovered and developed during the collaboration.

Further details of the agreement were not disclosed.

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Paris, France and Cambridge, MA, USA – May 19, 2016

Enterome Bioscience SA (“Enterome”), a pioneer in the development of pharmaceuticals and diagnostics based on the gut microbiome, is pleased to announce that it has opened a new office in Cambridge, MA to support its operations and corporate development activities in the US.

The office is located at Kendall Square, the heart of Boston’s booming biotechnology industry, well-known as the global hub for transforming scientific insights into new drugs. The new office brings Enterome closer to its existing partners in the US and provides opportunities to reinforce and extend its scientific expertise and network to develop its business further.

Rodolphe Clerval, Enterome’s Chief Business Officer, will head up the US office, and expects to expand the operation over the coming years.

Mr Clerval said: “Enterome has made great progress leveraging its expertise to unlock the microbiome and identify exciting opportunities to improve the treatment of serious diseases. We have established several partnerships and strong relationships in the US with companies and clinicians at leading research institutions. By starting operations in one of the most vibrant life sciences hubs in the world, we can leverage on these relationships and advance the development of Enterome.”

Enterome currently has partnerships with leading pharmaceutical companies and academic research institutes, including Johnson & Johnson Innovation/Janssen Biotech, Takeda and Abbvie in inflammatory bowel diseases; and the Mayo Clinic and Geisinger hospitals in metabolic disorders.

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Paris, France and Boston, MA – April 20 2016

ENTEROME Bioscience SA, a pioneer in the development of pharmaceuticals and diagnosticsbased on the gut microbiome, announces that it has raised €14.5 million in a Series C financing round. The round was led by existing investors, such as Seventure (including from its new Health for Life Capital fund) and Lundbeckfond Ventures, and included new investors. Nestlé Health Science also participated in the round as a new strategic investor. Financial terms of the investment were not disclosed.

Enterome will use the funds raised to advance the development of its lead drug candidate EB8018 into first clinical studies during 2016 as a potential treatment for inflammatory bowel diseases (IBD). EB 8018 is a novel small molecule FimH antagonist licensed from Vertex that specifically targets Adherent Invasive Escherichia coli (AIEC) proliferation in the gut, one of the main causes of inflammatory colitis in IBD sufferers. AIEC is an opportunistic pathogen able to thrive in the dysbiotic gut microbiome that results as IBD develops, prolonging and exacerbating the symptoms. EB 8018 acts to restore the dysbiotic microbiome to a normal state via a novel mechanism of action whereby the adhesion of AIEC to the gut wall and its proliferation is prevented.

In the diagnostics space, Enterome will pursue its development efforts in IBD and other microbiome-related diseases, where its unique technologies and insights can be leveraged on its own or under partnerships with diagnostic and pharmaceutical companies. Enterome will also use the funds to advance therapeutic programs in Immuno-Oncology.

Pierre Belichard, CEO, said: “We are pleased that our existing investors have taken the decision to make a further financial commitment to Enterome. We are also delighted that Nestlé Health Science has become a new strategic investor in the company to support our development programs. We anticipate that access to their expertise and broader capabilities will be valuable in helping us achieve our ambitions. With these new funds we anticipate making further significant progress towards our goal of creating new treatments for patients suffering from conditions where the gut microbiome plays a key role.”

Greg Behar, CEO of Nestlé Health Science, said: “The microbiome is a fast developing and new health frontier. Enterome has recognized expertise in identifying novel microbiome diagnostics. Our strategic investment in Enterome enables us to expand our microbiome portfolio ranging from diagnosis (Dx), to therapeutics (Rx) and nutritional therapies (Nx). We are excited to working with them.”

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Paris, France and Boston, MA – April 18 2016

ENTEROME Bioscience SA, a pioneer in the development of pharmaceuticals and diagnostics based on the gut microbiome, has signed an exclusive worldwide license agreement with Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) to research, develop and commercialize novel small molecule FimH antagonists for use in the treatment of inflammatory bowel diseases (IBD).

Enterome plans to take the lead compound in this program, known as EB 8018, into first human clinical trials during 2016 as well as a companion diagnostic to identify patients with inflammatory bowel diseases (IBD) who will benefit from their use.

Through application of its metagenomics platform, Enterome has identified a key bacterial species – adherent-invasive Escherichia coli (AIEC) – which is responsible for triggering inflammation in IBD. AIEC adheres to gut epithelial cells by virtue of FimH adhesion proteins on its cell surface, which bind to the CEACAM6 receptor on gut epithelial cells and allow the bacterial cells to invade the gut wall and proliferate. Research has shown that blocking FimH prevents the adherence and proliferation of AIEC, thereby reducing inflammation and providing new opportunities for the prevention and treatment of IBD.

“The rapid growth of evidence supporting the involvement of the microbiome in serious diseases is providing myriad new opportunities and targets for therapeutic intervention with small molecule drugs,” commented Pierre Belichard, CEO of Enterome. “The unique insights we have gained on the roles of specific constituents of the gut microbiome brought through our metagenomics platform strongly supports the central role of AIEC in inflammatory bowel diseases. Through this in-licensing agreement we are delighted to gain access to these novel FimH antagonists including EB8018, which we intend to advance into clinical trials during 2016, and which we believe could be transformative for the management and treatment of IBD.”

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Paris, France and Boston, MA – April 13, 2016

ENTEROME Bioscience SA, a pioneer in the development of pharmaceuticals and diagnostics based on the gut microbiome, announces that Pierre Bélichard, its Chief Executive Officer, will participate at the following conferences:

• FBR Healthcare Series: New Prescriptions: Innovation in the Treatment of Diseases and Infections, April 20^th, New York

Dr Belichard will participate in a panel entitled The Human Microbiome and Applications in Novel Therapeutics at 8:30 am EST.

• Guggenheim Securities Microbiome Day, April 21^th, New York

The conference will include members of the senior management team from leading microbiome companies, key opinion leaders and investors to discuss how the microbiome is being harnessed to develop novel therapies for a broad spectrum of medical conditions.

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Paris, France and Boston, MA, USA – January 7, 2016

Enterome Bioscience SA announces that it has entered into a collaborative research agreement with Janssen Biotech, Inc. (Janssen Biotech), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and the French National Institute for Agriculture Research (INRA).

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Osaka, Japan, Paris, France and Boston, MA, USA — January 6, 2016

Takeda Pharmaceutical Company Ltd. and Enterome Bioscience SA today announced they have entered into a strategic drug discovery collaboration to research and develop potential new therapeutics directed at microbiome targets thought to play crucial roles in gastrointestinal disorders, including inflammatory bowel diseases.

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