Université Toulouse III - Paul Sabatier

Newly appointed advisors are world-renowned experts in obesity, diabetes, and cardiometabolic diseases, spanning basic biology to late-stage development RICHMOND, Calif.--(BUSINESS WIRE)-- BioAge Labs, Inc. ("BioAge"), a clinical-stage biotechnology company developing therapeutic candidates for metabolic diseases, such as obesity, by targeting the biology of aging, today announced the formation of its Scientific Advisory Board (SAB). The SAB is composed of world-renowned leaders with expertise spanning metabolic disease biology, obesity medicine, and clinical development of blockbuster therapeutics. The SAB will work closely with BioAge's leadership team to advance the company's pipeline of novel treatments for age-related chronic metabolic diseases into mid- and late-stage clinical development. "We are thrilled to be working with this esteemed group of expert scientists and drug developers as we pioneer new approaches to treating age-related metabolic diseases," said Kristen Fortney, Ph.D., co-founder and Chief Executive Officer of BioAge. "Our advisors' wealth of experience across all phases of drug development, from scientific discovery through approval and commercialization, will be instrumental as we advance our lead product candidate into Phase 2 clinical trials for obesity." BioAge's lead product candidate azelaprag is an orally administered agonist of the apelin receptor APJ that has the potential to mimic the effects of exercise. In preclinical studies, azelaprag has demonstrated the ability to significantly increase weight loss while improving body composition and metabolic parameters when administered in combination with GLP-1 receptor agonists. The company plans to initiate a Phase 2 trial in mid-2024 evaluating azelaprag in combination with tirzepatide (Zepbound®) for the treatment of obesity in older adults (link). The members of the BioAge SAB are: Caroline M. Apovian, MD, FACP, FTOS, DABOM, Professor of Medicine at Harvard Medical School and Co-Director of the Center for Weight Management and Wellness (CWMW) at Brigham and Women’s Hospital. A leading expert in clinical management of obesity, Dr. Apovian has co-authored multiple U.S. and international obesity treatment guidelines. She co-founded the American Board of Obesity Medicine and served as President of the Obesity Society from 2017–2018. Cedric Dray, Ph.D., Associate Professor at INSERM and faculty member at the RESTORE Geroscience Center at Université de Toulouse III-Paul Sabatier. Prof. Dray has published multiple papers describing his pioneering work on apelin and is a world expert on the biology of the apelin pathway in aging, muscle physiology, and metabolic disease. The apelin pathway is the target of BioAge’s lead product candidate, azelaprag, expected to enter a Phase 2 trial for obesity starting in mid-2024. William Evans, Ph.D., Adjunct Professor of Human Nutrition at UC Berkeley and Adjunct Professor of Medicine (Geriatrics) at Duke University. As a former VP at GSK, he led the company's Muscle Metabolism Discovery Performance Unit, and has served as an investigator in multiple clinical trials of muscle aging. Dr. Evans was the first to describe sarcopenia, the age-related loss of muscle mass and strength. His research on muscle metabolism, aging, and functional capacity has resulted in more than 350 publications with more than 80,000 citations. Alexander Fleming, M.D., Founder and Executive Chairman of Kinexum, which provides strategic and operational guidance throughout the process of clinical development and drug commercialization. As a supervisory physician at the US FDA from 1986-98, Dr. Fleming led landmark regulatory reviews for first-in-class drugs for diabetes and other metabolic diseases including metformin, statins and insulin analogs. He also heads the not-for-profit Kitalys Institute, founded to catalyze progress in developing drugs and other ways to increase healthy longevity. Narimon Honarpour, M.D., Ph.D., Senior VP and Head of Global Development at Amgen, where he leads a team responsible for shaping program clinical development strategies through deep disease state knowledge and generating clinical trial evidence to enable pipeline progression. Since joining Amgen in 2011, Dr. Honarpour has held diverse roles across both cardiovascular and inflammation therapeutic areas. In 2019, he became head of Translational Medicine, and in his most recent prior role served as VP-Global Development for the General Medicine Therapeutic Area Head and JAPAC Development Head. Tim Rolph, D.Phil., Chief Scientific Officer and Co-Founder of Akero Therapeutics, a company devoted to developing novel therapies for patients with serious metabolic diseases, including efruxifermin, an FGF21 analog, for metabolic dysfunction–associated steatohepatitis (MASH). Previously, as Chief Scientific Officer of Pfizer's Cardiovascular & Metabolic Disease unit, Dr. Rolph oversaw the development of Steglatro (ertugliflozin) for type 2 diabetes and discovery of oral small-molecule GLP1R agonists and inhibitors of PCSK9 and DGAT2. "We are looking forward to working closely with the renowned experts on our SAB to harness the biology of apelin, an exercise mimetic, to improve the lives of patients living with obesity and other metabolic conditions,” said Eric Morgen, MD, co-founder and Chief Operating Officer of BioAge. “We will also leverage their broad expertise in drug development for metabolic diseases to guide the continued advancement of the other programs in our metabolic disease pipeline.” About BioAge Labs, Inc. BioAge is a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. The company’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that promoted metabolism and prevented muscle atrophy on bed rest in a Phase 1b trial. In mid-2024, BioAge plans to initiate a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has the potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing BGE-100, a structurally novel NLRP3 inhibitor, with plans to IND by the end of 2024. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, also address key pathways in metabolic aging.

Brown fat cells convert energy into heat -- a key to eliminating unwanted fat deposits. In addition, they also protect against cardiovascular diseases. Researchers have now identified the protein EPAC1 as a new pharmacological target to increase brown fat mass and activity. The long-term aim is to find medicines that support weight loss. Brown fat cells convert energy into heat -- a key to eliminating unwanted fat deposits. In addition, they also protect against cardiovascular diseases. Researchers from the University Hospital Bonn (UKB) and the Transdisciplinary Research Area "Life & Health" at the University of Bonn have now identified the protein EPAC1 as a new pharmacological target to increase brown fat mass and activity. The long-term aim is to find medicines that support weight loss. The results of the study have now been published in the journal Nature Cell Biology. Obesity is defined as a pathological increase in white fat, and has become a major problem worldwide, with a greatly increased risk of cardiovascular diseases such as heart attack and stroke. "Exercise and dieting are not enough to effectively and permanently shed the pounds," says corresponding author Prof. Alexander Pfeifer, Director of the Institute of Pharmacology and Toxicology at the University Hospital Bonn and member of the Transdisciplinary Research Areas (TRA) "Life & Health" and "Sustainable Futures" at the University of Bonn. "Our energy-dense foods lead to energy being stored in white fat. But losing weight isn´t that easy, as the body saves energy in response to a low-calorie diet. So our goal is to achieve additional energy release." Aim are therapies that keep the energy balance in equilibrium Brown fat cells, on the other hand, act as a biological oven and ensure, for example, that newborn babies can cope with cold exposure after birth. However, adults hardly have any brown fat, and it can be found mainly in young and slim people. "We therefore asked how brown fat mass can be increased while simultaneously reducing bad white fat," says Bonn postdoctoral researcher and first author Dr. Laia Reverte-Salisa. Together with researchers from the University Medical Center Hamburg-Eppendorf, Helmholtz Munich and the University of Toulouse-Paul Sabatier, the Bonn team investigated the cAMP signaling pathway in fat metabolism that plays a central role in fat cells. Using a mouse model, they discovered that the relatively unknown protein "exchange proteins directly activated by cAMP" (EPAC1), is responsible for the growth of brown fat. In addition, EPAC1 even increases the formation of brown fat cells in white fat, which are also known as "beige" cells. Prof. Pfeifer's team also showed that the signaling pathway is also active in human fat cells. In addition, they confirmed the function of EPAC1 in human organoids -- organ-like microstructures that serve as a human brown fat model. The Bonn researchers further found that a non-functional human EPAC1 gene variant is associated with an increased body mass index (BMI). "Our study shows that EPAC1 is an attractive target to increase brown fat mass and thus also energy expenditure," says Prof. Pfeifer. In view of the worldwide increase in obesity, he hopes to develop novel therapies that help those affected to combat metabolic diseases. This study was conducted in the context of the DFG Collaborative Research Center Transregio-SFB 333 "Brown and Beige Fat -- Organ Interactions, Signaling Pathways and Energy Balance (BATenergy)," which is pursuing a better understanding of the different types of adipose tissue and their role in metabolic diseases.

Liege, Belgium, 25 MAY 2023 – 5:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that at its Annual General Meeting, held today all agenda items put to vote were approved, including the appointment of Directors for a two-year mandate. The Board of Directors is now made up of 7 members with varied backgrounds spanning both the financial and pharmaceutical sectors, bringing extensive expertise to Mithra covering all aspects of pharmaceutical development. The Board will include four new Directors, including: Ribono SRL, Mr. Sidney Bens (Independent Director) Sidney is a seasoned financial executive, with over 35 years’ experience. He spent most of his career at Atenor, an international real estate development company listed on Euronext, where he served as Chief Financial Officer. Prior to this he worked in banking, as Senior Corporate Banker at Paribas Bank Belgium (now Belfius) and in Retail and SMC banking at BBL (now ING). Sidney holds a Masters degree in Finance, Accounting and Trade from Lucien Cooremans Institute, Belgium and a Postgraduate in Finance from KU Leuven, Belgium, (see resume). Mrs. Igne Beernaert (Independent Director) Igne is an experienced financial services professional, specializing in audit, corporate finance, internal controls, tax, management and M&A. She is the founder of Bedrijfsrevisor Beernaert, a financial advisory firm that provides audit, M&A and strategic financial consulting for growing companies, where she served as company auditor for the last 27 years. Prior to this, she founded bb3 Revisoren, another financial advisory firm. Igne holds a Masters degree in Applied Economics from KU Leuven, Belgium and a postgraduate degree in liability and insurance law from the University of Antwerp, (see resume). Life Science Strategy Consulting SRL, Mr. Christian Homsy (Independent Director) Christian is a leading life sciences executive with over 30 years’ industry experience. Most recently he founded and served as interim Chief Executive Officer and Board Member of biotechnology company Capstan Therapeutics. He was also founder, Chief Executive Officer and Board Member of Celyad SA for 15 years. He spent a large part of his career at Guidant Corporation (part of Boston Scientific and Abbott Labs) in a number of senior roles. Christian gained his Medical Doctorate at the University of Louvain, Belgium and his MBA at IMD Business School, Lausanne, Switzerland, (see resume). Gaudeto SRL, Mr. Jacques Galloy (Independent Director) Jacques has over 25 years of business leadership experience including private and public equity capital markets, focusing on digital imaging, medical technology, digital media and digital transition. He is currently the founder and managing partner of Guadeto SPRL, an investment consultancy firm advising small to mid-size media, health technology and digital transition companies. He is a current investor in 7 companies, entrepreneur in 5 businesses and charities, and has over 10 board mandates. He also has 12 years’ experience as Board member and CFO of EVS Broadcast Equipment SA, a worldwide leader in TV Technology niches and a top 30 Belgian listed company. Jacques holds a Masters in Commercial Engineering from Ulg-HEC Liège, Belgium, (see resume). Christian Moretti, Chairman of the Board, commented: « It is fantastic to welcome such established and experienced professionals to the Mithra Board of Directors. Their collective knowledge spanning both the financial and life sciences sectors will be invaluable to the Company as we continue the commercialization of our lead product, Estelle and develop our exciting and innovative pipeline of products to address key unmet need. » The General Meeting also renewed the mandates of: Selva Luxembourg SA, Mr. Christian Moretti (Chairman and Non-Executive Director) Christian is a seasoned financial executive who spent over 10 years in banking before founding the industrial holding Dynaction listed on the Paris stock exchange. He then focused on the development of one of the holding's subsidiaries, PCAS Biosolution, which he managed as CEO for 13 years and enabled it to become the European leader in the chemistry of complex molecules, employing more than 1,000 people worldwide. Christian holds a Masters in Marketing and Finance from HEC School of Management, Paris and a Masters of Business Administration from Columbia Business School, (see resume). Alius Modi SRL, Ms. Valérie Gordenne (Non-Executive Director) Valérie has over 20 years of experience in pharmaceutical Research & Development with extensive leadership experience in full drug development across a range of therapeutic areas in particular in women's health (CSO Mithra, CEO Novalon, General Manager Odyssea). Through the management of various functions and activities, she has developed a deep operational and strategic knowledge in drug development. She is currently Chief Scientific Officer at Auxin Surgery, CEO of the start-up Odix and an advisor in regulatory affairs. She has a Masters in Pharmaceutical Science, University Of Liege, Belgium and a Masters in Industrial Pharmacy from Inter-University, Belgium, (see resume). Eva Consulting SRL, Prof. Jean-Michel Foidart (Executive Director) Co-founder of Mithra, Jean-Michel is a trained doctor specializing in Obstetrics and Gynecology and is the author of more than 1300 publications on women’s health and experimental oncology. He is a member of many national and international scientific committees and is currently a Board member of the International Society of Gynecological Endocrinology. Jean-Michiel holds the Francqui Chair, Doctor Honoris Causa of the Pierre and Marie Curie University of Paris and the Paul Sabatier University of Toulouse. Professor Extraordinary, Honorary of the ULg and Perpetual Secretary of the Royal Academy of Medicine of Belgium. Professor Foidart graduated in Gynecology from the University of Liège and also obtained a PhD in cell biology and biochemistry, before directing its Department of Gynecology-Obstetrics, (see resume). ******** For more information, please contact: Investor relations : https://www.mithra.com/ About Estelle® Developed by Mithra, Estelle® is a novel patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source. In two phase 3 clinical studies conducted in 3,725 women, Estelle® was shown to be both safe and effective and met its primary efficacy endpoint of pregnancy prevention. It also delivered excellent results on a variety of secondary endpoints that demonstrated outstanding cycle control, bleeding control, safety, and tolerability. Mithra has signed 15 licensing deals for Estelle® with a number of leading women’s health companies covering more than 100 countries in the world. The product is marketed in Belgium by Gedeon Richter under the brand name DROVELIS® and by Ceres Pharma under the brand name -LYDISILKA®. About Mithra Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill Estelle®, Mithra is now focusing on its second product Donesta®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 230 staff members and is headquartered in Liège, Belgium. www.mithra.com ESTELLE®, DONESTA®, LYDISILKA are registered trademarks of Mithra Pharmaceuticals or one of its affiliate Important information The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Attachment 2023-05-XX_Mithra_Press-release_Board-Updates_FR- Final