Seres Therapeutics, Inc.

– Developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions – – Lead clinical program, KAI-9531, an injectable GLP-1/GIP receptor dual agonist, demonstrated compelling results in Phase 2 trials in obesity and type 2 diabetes – – Ron Renaud, Chief Executive Officer, will lead seasoned executive team with deep industry expertise; Industry veteran John F. Milligan named Chair of the Board – – Financing co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital – BOSTON, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (“Kailera” or “the Company”), today announced its launch as a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity and related conditions. Kailera launches with a $400 million Series A financing co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital. The Company is developing several clinical-stage injectable and oral therapies that have demonstrated potential as best-in-class treatments for chronic weight management. Kailera acquired exclusive rights for global development and commercialization of a portfolio of four metabolic disease assets outside of greater China from Jiangsu Hengrui Pharmaceuticals Co., Ltd (Hengrui), a leading global pharmaceutical company, in May 2024. Kailera’s most advanced program, KAI-9531 (in development as HRS9531 in China) is an injectable GLP-1/GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide) receptor dual agonist that demonstrated compelling results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including KAI-7535, a clinical-stage oral small molecule GLP-1 receptor agonist, KAI-9531 formulated as a once-daily oral tablet, and KAI-4729, an injectable GLP-1/GIP/glucagon receptor tri-agonist. “In this period of rapid innovation in the metabolic space, I believe that Kailera is poised to make an impact beyond the current market leaders. We have an incredible opportunity to develop next-generation treatments for chronic weight management, helping people reclaim their health and live their lives to the fullest,” said Ron Renaud, Chief Executive Officer, Kailera Therapeutics. "With a clinically-advanced, differentiated pipeline, a talented and experienced team with a track record for building companies with lasting impact, and the support of a world-class investor syndicate, we are uniquely positioned to advance innovative therapies that have the potential to meaningfully impact both quality of life and overall health for many people.” Mr. Renaud brings more than 25 years of biotech leadership to Kailera, with deep expertise in executive leadership, finance, and operations. As CEO of Cerevel Therapeutics, he guided the company through significant milestones, culminating in its acquisition by AbbVie in 2024. Previously, Mr. Renaud spearheaded Translate Bio’s growth from an early-stage startup to a publicly traded company, establishing it as a leader in mRNA technology. As CEO of Idenix Pharmaceuticals, he streamlined operations and built a robust promising portfolio of potential treatments for hepatitis C. In conjunction with the launch, the Company also announced several key leadership appointments. Kailera’s seasoned management team brings deep industry experience and will be responsible for establishing operational infrastructure and driving critical milestones. The initial Kailera executive leadership team appointments include: Doug Bakan, Ph.D., Chief Technology Officer, formerly of Ventyx Biosciences, Arena Pharmaceuticals, and Medicis PharmaceuticalPaul Burgess, Chief Operating Officer and Chief Business Officer, formerly of Cerevel Therapeutics, Translate Bio, and CivitasPaula Cloghessy, Chief People Officer, formerly of Seres Therapeutics, Translate Bio, and Joule Unlimited TechnologiesScott Wasserman, M.D., Chief Medical Officer, formerly of Frazier Life Sciences, Latigo Biotherapeutics, and Amgen Additionally, John F. Milligan, Ph.D., has joined the Board of Directors as Chair. Dr. Milligan previously served as the President and Chief Executive Officer of Gilead Sciences, where he was instrumental in transforming the company from an early-stage private company into a global, multi-billion-dollar leader in biopharmaceuticals. Over the course of his three-decade tenure, he helped establish Gilead’s global presence and played a key role in the development and commercialization of over 25 innovative therapies, including the development of groundbreaking treatments for HIV and HCV. “I’m thrilled to join Kailera in their commitment to deliver next-generation therapies for obesity and related conditions,” said Dr. Milligan. “I look forward to working with the Kailera team to advance therapies with the potential to more comprehensively meet patients’ needs in short and long-term weight management and metabolic diseases, with a focus on improved efficacy and tolerability.” About Kailera TherapeuticsKailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that demonstrated positive results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com and follow us on LinkedIn and X. Contact Information Maura GavaghanVice President, Corporate Communications and Investor Relationsmaura.gavaghan@kailera.com

To avoid the pitfalls of microbiome drug development, Florey is aiming to get FLR-101 into the world as a medical food instead. Antibiotics are one of the most common medicines in the world, with about 236 million prescriptions in the U.S. in 2022 alone, according to the Centers for Disease Control and Prevention. These drugs are great for clearing out bacterial infections but also have an unintended side effect: They wreak havoc on the healthy microbes that call our guts home.“There's a lot of research and clinical data that shows that the disruption of the beneficial microbes in your gut actually is a high risk factor for many diseases,” Andrés Cubillos-Ruiz, Ph.D., a microbiologist and synthetic biologist at the Wyss Institute for Biologically Inspired Engineering at Harvard University, told Fierce Biotech in an interview. “This is a huge problem that is still a highly unmet need.”Florey Biosciences, a company spun out of Cubillos-Ruiz’s work in the MIT and Wyss Institute lab of James Collins, Ph.D., seeks to fill this unmet need with genetically modified microbes and a unique regulatory approach. The company launched Oct. 1 with pre-seed funding from Seerave Ventures, the investment arm of the microbiome-focused Seerave Foundation, according to a release. The team hopes to close out a seed funding round by mid-2025, Cubillos-Ruiz said. In addition to Cubillos-Ruiz, who is CEO, and Collins, Raphaël Gayet, Ph.D., is also a co-founder. Collins is a synthetic biologist known for his entrepreneurial spirit; he’s a co-founder of the Flagship Pioneering-launched Cellarity as well as the publicly traded Synlogic Therapeutics and Senti Biosciences, among others.Florey’s lead program is a genetically modified yeast called FLR-101. This yeast produces an enzyme that breaks down beta-lactam antibiotics, which make up about 50% of all antibiotics used, Cubillos-Ruiz said. Because the yeast is localized to the gut, its anti-antibiotic activity shields the microbiome there while the antibiotic is still able to clear an infection elsewhere in the body. The team first tested this approach using modified bacteria in a 2022 paper, and has now improved upon the method.“We have technologies that prevent these genes from jumping into bacteria,” Cubillos-Ruiz said, so that the yeast’s antibiotic-destroying power can’t be picked up by other microbes.When it came to forming a strategy for Florey, Cubillos-Ruiz learned from predecessors like Seres Therapeutics and Rebiotix (acquired by Ferring Pharma) about the perils of developing drugs for the microbiome. “You were going to incur huge development costs, and then you're going to create a product that doesn't have the market access and the market opportunity,” he said. To avoid those pitfalls, Florey is aiming to get FLR-101 into the world as a medical food instead of as a drug.Medical foods are products that are meant to be taken orally for the management of a disease or condition under the supervision of a physician but that don’t require a prescription. While drugs require studies of safety and efficacy, reporting of side effects and a thorough label review before hitting the market, medical foods do not.There is no formal stamp of approval that the FDA gives to medical foods, but the agency does provide guidelines for the products. Once FLR-101 is recognized as safe to consume, it could be put on the market right away along with the countless other probiotics that claim to support gut health.However, in order to market the modified yeast as being able to manage the microbiome dysfunction that comes from antibiotic use, Florey plans to run human trials to test whether FLR-101 paired with antibiotics leads to less microbiome damage than antibiotics alone. If successful, Florey would be able to add that information to FLR-101’s label and distinguish it from the other probiotics alongside it on the shelf. To bolster FLR-101’s chances of successfully navigating the medical foods regulatory pathway, Florey is adding Peter Hutt, former chief counsel of the FDA, to its board of directors, the company said in the release. At the FDA, Hutt helped craft the medical food regulatory framework, and he also played a pivotal role in the creation of nutrition labels, according to the release.“We have all the pieces of the puzzle to have a biotech product that, in its core, its technology is highly advanced, but we can put it in the market using different ways,” Cubillos-Ruiz said.Putting out products as consumer goods rather than prescription drugs presents a marketing challenge: How do you make sure patients, physicians and pharmacists know about your product? Cubillos-Ruiz sees an opportunity in FLR-101’s partner, antibiotics.“There is a big push from government agencies and within medical societies to be better antibiotic stewards,” he said. Hospitals don’t want readmissions of patients who develop health problems due to antibiotic-weakened gut microbiomes, and antibiotics tend to have slim profit margins. Pairing the drugs with a proven probiotic could be a way to boost revenues, Cubillos-Ruiz suggested.The company is currently preparing in vivo safety studies in preparation for human trials, Florey said in the release. If all goes well, Florey hopes to launch its flagship product in three years, Cubillos-Ruiz said.First-time biotech CEO Cubillos-Ruiz thinks that in 10 years, we’ll all look back and wonder how we could let antibiotics run roughshod over our gut microbes for so long. It will be like “going to a beach day and not using sunscreen to protect yourself from the sun,” he said.

Transaction supports further development of SER-155, following recent promising clinical data, and other cultivated live biotherapeutics, for multiple medically vulnerable patient populations at high risk of life-threatening bacterial infections Cash received at completion, along with anticipated future deal payments, extends runway into Q4 2025 CAMBRIDGE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), (“Seres” or the “Company”), a leading live biotherapeutics company, today announced that it has completed the previously announced sale of its VOWST business to Société des Produits Nestlé S.A (“SPN”, and with certain of its affiliates, collectively, “Nestlé Health Science”). “We are pleased to complete the sale of VOWST to Nestlé Health Science, which strengthens our financial position and sharpens our focus on developing our novel platform in multiple medically vulnerable patient populations at high risk of life-threatening bacterial infections and associated negative clinical outcomes,” said Eric Shaff, President and CEO of Seres Therapeutics. “The recently announced highly encouraging clinical results from our Phase 1b Cohort 2 study, demonstrating that SER-155 was associated with a significant reduction in both bloodstream infections and systemic antibiotic exposure, as well as a lower incidence of febrile neutropenia, as compared to placebo, in patients undergoing allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT), reinforces our conviction in the potential of our cultivated live biotherapeutics platform to provide significant patient benefits and meaningful commercial opportunity. The resources provided by the VOWST transaction will support our plans to progress SER-155, including applying for Breakthrough Therapy designation, and additional biotherapeutic pipeline programs.” Mr. Shaff continued, “We are emerging from this transaction a more streamlined organization, with our debt fully retired and an investment plan focused on advancing our promising pipeline programs. The Company’s headcount will decrease from approximately 200 to 100, principally due to the transition of manufacturing and quality team members from Seres to Nestlé Health Science, positioning the organization to efficiently progress our strategy. We want to thank all our colleagues for their contributions to Seres and to developing VOWST for patients. We look forward to working with Nestlé Health Science to ensure a smooth transition and wish them all the best as the stewards of VOWST moving forward.” In addition to Seres’ plans to further develop SER-155 in allo-HSCT, the Company intends to evaluate the program in additional medically vulnerable patient populations at high risk for bacterial bloodstream infections, such as cancer neutropenia (including autologous HSCT and CAR-T patients), and solid organ transplants where there is significant unmet need, severe consequences of infection and a high cost burden on the healthcare system, and thus potential for meaningful commercial opportunity. Seres is also developing another proprietary live biotherapeutic composition, SER-147, designed to improve clinical outcomes in compromised chronic liver disease patients at high risk of bacterial infections. Seres continues to evaluate opportunities to maximize value creation. The Company believes there is potential to pursue both internal clinical development and externally supported efforts, including partnerships, to evaluate its biotherapeutics in multiple target populations that could benefit patients and create significant commercial value. Economics and Cash RunwayUpon the closing of the transaction, Seres received gross proceeds of approximately $175M, including payment of an up-front, prepaid milestone and equity investment, less approximately $20M in settlement of net obligations payable to Nestlé Health Science. Seres is due to receive installment payments of $50M in January 2025, and $25M (less up to approximately $1.5M in employment-related payments to Nestlé Health Science), in July 2025, subject to Seres’ material compliance with its transition obligations. The Company is also eligible to receive future milestone payments of up to $275M, based on VOWST worldwide net sales. Considering Seres' current cash reserves, future operating plans, and anticipated capital from the sale, as well as ongoing transaction obligations, the Company expects its cash runway to extend into Q4 2025. Advisors to SeresLazard acted as sole investment banker to Seres in connection with the VOWST sale, and Latham & Watkins LLP serves as the Company’s legal counsel. About Seres TherapeuticsSeres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics. Seres led the successful development and approval of VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024. The Company is developing SER-155, which has demonstrated a significant reduction in bloodstream infections and related complications (as compared to placebo) in a clinical study in patients undergoing allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). SER-155 and our other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via single-strain cultivation, rather than from the donor-sourced production process used for VOWST. The Company is also advancing additional cultivated oral live biotherapeutics for medically vulnerable populations, including those with chronic liver disease, cancer neutropenia, and solid organ transplants. For more information, please visit www.serestherapeutics.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about the financial terms and use of proceeds of the transaction; the results of our clinical studies; future product candidates, development plans and commercial opportunities; operating plans and our future cash runway; our planned strategic focus and other statements which are not historical fact. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: (1) we have incurred significant losses, are not currently profitable and may never become profitable; (2) our need for additional funding; (3) our history of operating losses; (4) our novel approach to therapeutic intervention; (5) our reliance on third parties to conduct our clinical trials and manufacture our product candidates; (6) the competition we will face; (7) our ability to protect our intellectual property; (8) our ability to retain key personnel and to manage our growth; (9) the effect of the transaction on our ability to retain and hire key personnel and maintain relationships with our customers, suppliers, advertisers, partners and others with whom we do business, or on our operating results and businesses generally; (10) the risks associated with the disruption of management’s attention from ongoing business operations due to the obligation to provide transition services; (11) our failure to receive the installment payments or the milestone payments in the future; (12) the uncertainty of impact of the 50/50 profit and loss sharing arrangement on our reported results and liquidity; and (13) we may not be able to realize the anticipated benefits of the transaction. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), on August 13, 2024, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor and Media Contacts:IR@serestherapeutics.com Carlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com This press release was published by a CLEAR® Verified individual.