List of Microbiome Companies with Phase 2 Active Clinical Trial - 36

Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies addressing multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been “fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time. APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale. APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.

Aurealis Therapeutics is a Swiss-Finnish Cell and Gene Therapy Platform Company. Our multi-target cell and gene therapy platform, based on genetically modified safe lactic acid bacteria, addresses unmet medical needs: Chronic Wounds - Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers - deadly Cancers - Ovarian Cancer, Peritoneal Carcinomatosis - Inflammation. After successfully completing our Phase 1 clinical study in Diabetic Foot Ulcer (DFU) patients with our lead clinical product AUP-16, our DFU Phase 2 study is ongoing in Italy, Germany and Poland. Venous Ulcers and other ulcers will follow. In Oncology, we are building on impressive pre-clinical data with Oncolytic Bacteria lead candidate AUP-55, which shows increased survival in Ovarian Cancer and peritoneal carcinomatosis. Our pipeline also includes Inflammation, at discovery stage.

Azitra, Inc. is a preclinical stage biotechnology company harnessing the power of the microbiome to treat skin disease. The Company was founded in 2014 by scientists from Yale University and works with world-leading scientists in dermatology, microbiology, and genetic engineering to advance its programs in atopic dermatitis and targeted orphan indications. For more information visit www.azitrainc.com.

BGI was founded in 1999 as a research organization to support the Human Genome Project. Over the years, BGI’s in-house research has contributed to the development of the field of Genomics in significant ways, as evidenced by a wealth of peer-reviewed publications in prestigious scientific journals. Today, BGI is actively participating in the fields of Cancer Research, Bio-sustainability and Personalized Medicine through a global network of collaborators. BGI Genomics is the world’s leading provider of genomic and proteomic services, now serving customers in more than 66 countries. We provide academic institutions, pharmaceutical companies, health care providers and other organizations with integrated genomic and proteomic services and solutions across a broad range of applications spanning basic and translational research, drug discovery, agriculture and health care. To provide these services, we operate a large network of service Laboratories in China, Hong Kong, the US and Europe. Our customers benefit from the highest level of sequencing experience in the world to support their research and drug discovery projects. Our service laboratories operate under strict internationally recognized quality systems, such as those from CAP and ISO. More recently, BGI developed and launched its own DNBseq™ sequencing technology, based on DNA Nanoball sequencing technology that was invented in our Complete Genomics research facility in Silicon Valley, California. Scientists around the world now rely on DNBseq NGS services for the highest quality data at the lowest cost.

BioGaia is a Swedish probiotic company that has been at the forefront of microbiome research for more than 30 years. BioGaia develops, markets and sells probiotic products within the areas of gut, oral, immune and bone health. Our probiotic products with bacterial strains from the L. reuteri species are among the most scientifically well-documented probiotics. The class B share of BioGaia is quoted on the Mid Cap list of the Nordic Exchange Stockholm.

BIOHM optimizes digestive health by combining good bacteria, good fungi and enzymes to break down digestive plaque, allowing for total gut balance. This allows BIOHM's 30 billion live active cultures to maintain, support, and promote the balance of the total microbiome in the digestive system.

OUR COMPANY BioMed Valley Discoveries, Inc., is a clinical stage biotechnology company with a mission to address unmet patient needs across a wide spectrum of diseases. Operating since 2007, BioMed Valley Discoveries advances its mission with commercial capabilities and resources typically unavailable to academic institutions. As a member of the Stowers Group of Companies, our stable long-term funding allows us to advance programs that may not fit within the model of more traditional clinical development groups. OUR APPROACH BioMed Valley Discoveries leverage several hundred experts at leading academic and clinical institutions to move projects forward in the early stages of clinical development. Our partners have a proven track record of scientific rigor and experience in efficient study execution. Our selection of development partners is based on our desire to address unmet patient needs and achieve critical development milestones as swiftly as possible. Through this approach, we endeavor to quickly answer scientific questions and determine next steps in the development process. OUR TEAM BioMed Valley Discoveries calls on the talents of a core leadership team of scientists who are focused, passionate, and committed to advancing new medical innovations to improve the lives of patients with difficult-to-treat diseases. Our team brings extensive experience from pharma, biotech, and academia. By utilizing unique advantages from each of these settings, BioMed Valley Discoveries creates a highly creative and functional drug development environment. We take a nimble and thoughtful approach to advancing programs with a focused sense of urgency, allowing for the most efficient path forward.

BiomX (NYSE America: PHGE) is developing both natural and engineered phage cocktails and personalized treatments designed to target and destroy harmful bacteria in chronic diseases, including cystic fibrosis and diabetic foot osteomyelitis. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.

BioTherapeutics Inc (BTI) synergistically combines the power of advanced computational modeling, data analytics and artificial intelligence with translational experimentations to accelerate the development of innovative products for precision medicine and health. Our computational platform assembles biomedical and healthcare data from the molecular, cellular, tissue and population levels and leverages the latest innovations in technology to turn those data into answers to complex biological questions and solutions to healthcare's problems.

Carbiotix is an award-winning biotechnology company pioneering the onsite upcycling of plant-based side-streams. Carbiotix mission is to improve the health of people by increasing the consumption of prebiotics and other active ingredients from upcycled side-streams. Carbiotix offers one core service today called NutraCycle, an on-site upcycling and fortification service allowing food & beverage, ingredient, and feed producers to turn plant-based products into healthier, more profitable, and sustainable products.

We are a clinical stage biopharmaceutical company developing developing breakthrough immunomodulatory drugs for the treatment of cancer and inflammatory diseases. We have developed two highly promising pipelines of clinical and pre-clinical candidates with a focus on cancer and auto-immune diseases: - OncoMimics™: highly effective, off-the-shelf therapeutic vaccines against cancers (EO2401, EO2463). EO2401 is in Phase 1/2 clinical trials in patients with glioblastoma and adrenal tumors. EO2463 is in a Phase 1/2 clinical trial for indolent non-Hodgkin B-cell lymphomas. - EndoMimics™: a pipeline of next generation bioactives acting like human hormones or cytokines for the treatment of immune diseases. EB1010, the lead candidate, is a potent local inducer of IL-10 designed to provide improved therapeutic outcomes for patients with IBD. In addition, Enterome’s clinical candidate sibofimloc (also referred to as TAK-018) is advancing through a Phase 2 clinical trial in post-operative Crohn’s disease. Sibofimloc has been partnered with Takeda globally, with Enterome retaining a significant profit share in the US.

Official LinkedIn page for Esperion. At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc. Community guidelines: https://bit.ly/3vLCGdO Certified Great Place To Work®

Evelo Biosciences, Inc., a biotechnology company, discovers and develops oral biologics for the treatment of inflammatory diseases and cancer. It is developing EDP1815, a whole-microbe candidate for the treatment of inflammatory diseases; and is in clinical development trial for the treatment of psoriasis and atopic dermatitis, as well as for the hyperinflammatory response associated with COVID-19. The company also engages in developing EDP1867, an inactivated investigational oral biologic for the treatment of inflammatory diseases; EDP2939, an extracellular vesicle investigational oral biologic for the treatment of inflammatory diseases; and EDP1908, a product candidate for oncology. Evelo Biosciences, Inc. was incorporated in 2014 and is headquartered in Cambridge, Massachusetts.

ExeGi Pharma is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. Our team leverages the field of microbiome science to deliver novel, clinically supported, live biotherapeutic and probiotic treatments for a variety of unmet medical needs for both humans and veterinary applications. Makers of Visbiome and Visbiome Vet high potency probiotics.

At Exeliom Biosciences, we develop single bacterial strain drug candidates to deliver first-in-class microbiome-based therapeutics (also known as Live Biotherapeutics) for the treatment of immune-mediated diseases, with specific focus on inflammatory bowel diseases (IBD), and Crohn’s Disease as a first indication

Forte Biosciences is a clinical-stage biopharmaceutical company whose lead product candidate is FB102. FB102 is a proprietary molecule with potentially broad autoimmune and autoimmune-related applications. The Company’s FB102 program aims to address key pathways implicated in these indications with a CD122 antagonist. CD122 is a subunit of IL-2/IL-15 receptors which are key regulators of NK cells and certain T cell subsets. Significant reductions in NK cell pharmacodynamic marker of FB102 mechanism was observed supporting the in vitro as well as the NHP data and mechanism of action of FB102. A phase 1 healthy volunteer SAD/MAD study was successfully completed and demonstrated a good safety profile. We initiated patient-based studies in celiac disease in the third quarter of 2024.

Freya™ is a clinical-stage company taking an innovative approach to women’s health, with microbial immunotherapies aimed at relieving the chronic inflammation underlying a range of reproductive system diseases uniquely afflicting women.

Genome & Company is a global pharmaceutical bio company that focuses on research and development of microbiome medicines and new drug targets ('targets')-based immunotherapy agents based on abundant clinical data and multi-omics technology (Multi-Omics). Since its establishment in 2015, Genome & Company has been a global leader in the field of microbiome immuno-oncology drugs and new target immuno-oncology drugs, implementing the 'Bed-to-Bench' strategy (clinical data-based research) of GNOCLE™, an independent drug candidate discovery platform. Development Strategy), we have collaborated with major domestic and foreign pharmaceutical and bio companies and research-oriented hospitals. In the future, Genome & Company will not only accelerate the development of innovative treatments for high unmet medical needs by utilizing the microbiome and new drug targets, but will also strengthen its production and commercialization capabilities to become a fully integrated pharmaceutical bio company.

Intralytix, Inc. is a biotechnology company focused on the discovery, production and marketing of bacteriophage-based products to control bacterial pathogens in environmental, food processing, and medical settings. The company makes phage that target E. coli, Salmonella, and Listeria in pet and human food.Intralytix has developed and is continuing to develop phage preparations for preventing and treating bacterial diseases of pets and other animals, including agriculturally-important animals. Other products include phage mixtures as probiotics.Intralytix’s is also developing phage preparations for treating infected wounds.

Jarrow Formulas is a California-based formulator and supplier of nutritional supplement products including vitamins, minerals, probiotics, concentrates, and enzymes.

At Kallyope, we focus on big health challenges that matter to patients and families. We aim to discover and develop effective, easy to use, and well-tolerated oral agents addressing metabolic, neurological, and gastrointestinal diseases. Inside every human body is a complex, unexplored network of metabolic, neurological, and gastrointestinal interconnections. Our scientists are unlocking the mysteries of this network to develop oral therapies for obesity and diabetes; neurological disorders, including migraine; and gastrointestinal disease, including celiac disease. Based in New York City, we are home to some of the world’s most intrepid scientific minds from the world’s top institutions, working alongside a seasoned team with a proven track record of success in drug discovery and development. Together, we are leveraging multiple sophisticated technologies and internally-developed capabilities to bring fundamentally new solutions to some of the most pressing unmet needs in human health.

KoBioLabs is recognized for its international level of microbiome therapeutic technologies. In particular, our researchers have a distinctive position in the microbiology field globally with their presence in the ongoing International Human Microbiome Consortium [IHMC].

Next generation CRISPR technology for programmed cell death. Focused on developing therapies for infectious disease and the microbiome. Locus Biosciences’ novel approach to precision antimicrobials works by taking advantage of a part of an immune system present in many bacteria called the CRISPR-Cas system. The CRISPR-Cas system protects bacteria from invaders such as viruses by creating small strands of RNA called CRISPR RNAs, which match DNA sequences specific to a given invader. When the CRISPR RNAs find a match, they activate Cas proteins that cut the DNA.

Mikrobiomik is a bio-pharmaceutical company founded to conduct research into and develop medicines based on the human microbiome. Our vision We aspire to be the first company in the world to market a medicine based on faecal microbiota in the EU. To that end, we are holding talks with both the EMA (European Medicines Agency) and the AEMPS (Spanish Agency for Medicines and Health Products) with a view to establishing protocols on the regulatory requirements for securing an MAA (Marketing Authorization Application) via centralised procedure. Our values Mikrobiomik seeks to lead the paradigm shift entailed by designing therapeutic solutions based on the human microbiome through excellence in its processes, empathising with chronic patients for whom no curative treatments are available, always from the perspective of networking with all stakeholders in the sector.

Founded in 1895, Nexira is a family owned company who built its reputation as the world leader in acacia gum. Today Nexira is a global leader in natural ingredients and botanical extracts for food, nutrition, and dietary supplements. Our ingredients are perfectly suitable for the formulation of clean label products. Nexira manufactures in France a wide range of natural ingredients with recognized health benefits, such as Fibregum™ an all-natural, organic and GMO-free source of soluble dietary fiber. Nexira's portfolio for food industry includes a large range of branded natural acacia gum ingredients with exceptional functional properties (Emulsifiers & stabilizers, coating agents, texturizers, encapsulating agents…). Nexira's portfolio for supplement industry includes premium nutraceuticals, strongly supported with scientific & marketing supports, for digestive health, weight management, sports nutrition, joint health and men & women’s health.

Persephone is pioneering the use of synthetic biology for microbial products that impact patient and infant health. We are building an end-to-end platform to industrialize the development of engineered cells that restore health to damaged human ecosystems. The company was founded in the summer of 2017 by synthetic and metabolic engineering pioneers, Stephanie Culler PhD, and Steve Van Dien PhD.

Probi® is a global company focused exclusively on researching, manufacturing, and delivering probiotics for supplements and functional food. We are experts at managing stable, live bacteria from R&D through every stage of the manufacturing process, and are dedicated to making the health-enhancing benefits of probiotics available to people everywhere. Our health concepts, formulations, and formats are supported by robust clinical documentation. Since our founding in 1991 at Sweden's Lund University, Probi has expanded its operations to more than 40 markets. We hold more than 400 patents globally.

Probiotical is an Italian family-owned company specialized since 1985 in probiotics manufacture, from the raw material to the finished products, with very high quality, guaranteed stability and scientifically backed strains. We are driving innovation in a variety of functionalities and technologies. We offer our customers wide opportunities of customization and range extensions for probiotic blends and finished products ready-to-market, either under Probiotical's brand or in private label.

science backed probiotics, prebiotics & bioactive botanicals for targeted restoration res makes physician developed & physician recommended supplements creator of the world's first respiratory probiotic resB!

Siolta Therapeutics is a clinical-stage biotech company developing live biotherapeutics to improve outcomes in conditions with unmet medical needs. Our offices and laboratory are located in San Carlos, CA.

SNIPR Biome is the leading CRISPR Microbiome company. Our mission is to develop CRISPR-based medicines that give hope for effective and safe treatment of difficult-to-treat diseases in the future. Precision killing of bacteria has the impact to revolutionise the management of untreatable and difficult-to-treat infections as well as complex diseases directly impacted by the human microbiota.

Solarea Bio is a clinical-stage biotechnology company in Cambridge, MA developing plant-based microbial solutions to some of the world's largest health problems. Solarea was founded in 2017 by a group of scientists and entrepreneurs eager to radically alter our understanding of the human microbiome and utilize its power to improve human health. The Solarea breakthrough came from the combined efforts of the company's co-founders who established a link between the discovery of an untapped source of microorganisms with probiotic potential in healthy foods, and their applications in inflammatory processes including the gut-musculoskeletal axis. Using powerful genomic and bioinformatic tools, Solarea is mining its novel microbial strain collection to identify synergistic combinations of microbes and prebiotic plant fibers to develop solutions for patients suffering from inflammatory processes.

From discovery to scale, Verb Biotics applies science, technology, and intentional development to deliver microbiome health solutions. Verb Biotics is a business-to-business ingredient supplier of pro, post, and synbiotics for food, beverage, and dietary supplement brands.

Viomeanalyzes your microbiome and uses artificial intelligence to process the results and provide dietary advice.

Winclove Probiotics, quality of life with probiotics Since 1987, Winclove Probiotics has specialized in the development and production of probiotics. We work with passionate business partners, leading universities, various research institutes and university hospitals around the world to develop effective indication-specific probiotics. Aiming for long-lasting, sustainable and strategic partnerships, we not only offer innovative, high-quality and competitive probiotic solutions but also share our scientific knowledge as much as possible. At Winclove Probiotics, commitment, drive and optimism are important. Our Great Place to Work certification also shows that we have a company culture of humanity, diversity and trust. Since 2020, we have been part of the B Corp community, joining forces with like-minded companies to protect our planet and contribute to a sustainable economy. Together, we are using ‘business as a force for good'. -- Winclove Probiotics, kwaliteit van leven met probiotica Sinds 1987 is Winclove Probiotics gespecialiseerd in de ontwikkeling en productie van probiotica. Wij werken met gedreven businesspartners, vooraanstaande universiteiten, uiteenlopende onderzoeksinstituten en (universitaire) ziekenhuizen wereldwijd om effectieve indicatiespecifieke probiotica te ontwikkelen. We streven naar langdurige, duurzame en strategische partnerships waarbij wij niet uitsluitend innovatieve, hoogwaardige en concurrerende probiotica-oplossingen bieden, maar ook zoveel mogelijk onze wetenschappelijke kennis delen. Bij Winclove Probiotics zijn betrokkenheid, gedrevenheid en optimisme belangrijk. Ons Great Place to Work-certificaat toont tevens aan dat we een bedrijfscultuur van menselijkheid, diversiteit en vertrouwen hebben. Sinds 2020 zijn we onderdeel van de B Corp-community en bundelen we met gelijkgestemde bedrijven de krachten om onze planeet te beschermen en bij te dragen aan een duurzame economie. Samen gebruiken we ‘business as a force for good.'

Yakult is the world's leading probiotic beverage created in Japan in 1935. It is produced by Yakult Honsha Co., Ltd - the world's pioneer in probiotics. Today, Yakult is sold in more than 30 countries and regions around the world. Our company's portfolio includes a range of consumer, cosmetic and pharmaceutical products. For additional company information, please visit www.yakult.co.jp/english/. Science and research are the basis of our business. We have institutes in both Japan and Europe that are committed to discovering the endless applications for probiotics as well as the use of intestinal bacteria in human health globally. For more information about our science institutes, please visit www.yakult.co.jp/institute. Bringing Yakult to America is just one more step towards fulfilling Yakult's mission: to contribute to the health and happiness of every person around the world through the pursuit of excellence in life sciences and the study of microorganisms. We hope to achieve this goal while providing education to people about healthier living, developing community programs where we do business, and collaborating with medical doctors, dietitians and researchers. Yakult U.S.A. Inc. is a subsidiary of Yakult Honsha Co., Ltd. and is headquartered in Fountain Valley, CA. It supports Yakult's business in the United States and Canada. To contact our offices please email yakult@yakultusa.com.