University of Chile

New Beyfortus data featured at IDWeek reinforce real-world effectiveness against RSV disease and hospitalization in infants Paris, October 9, 2024. Sanofi advances its ambition to protect all infants from respiratory syncytial virus (RSV) disease with new Beyfortus (nirsevimab) data to be presented at the Infectious Disease Society of America’s IDWeek 2024 annual meeting in Los Angeles, California, from October 16-19, 2024. Thomas TriompheExecutive Vice President, Vaccines, Sanofi “The data featured at IDWeek from several national immunization programs will reinforce the proven efficacy and favorable safety profile of Beyfortus against RSV disease and hospitalization in infants. In just the first year of implementation, Beyfortus has demonstrated high real-world effectiveness consistently exceeding 80%. In addition, Beyfortus delivers this protection in the right dose for the right baby. We're proud to set a new standard with Beyfortus as the only approved and proven RSV protection for infants regardless of whether they are born before or during the RSV season, at term or preterm, healthy or with underlying conditions.” Beyfortus doses continue to be shipped to meet global commitments ahead of the 2024-2025 RSV season. A second manufacturing filling line has been approved by regulatory authorities in the US, Canada, and Europe and represents the majority of our supply for the 2024-2025 season. A third filling line, expected to provide additional doses for the 2024-2025 season, is approved by the European Medicines Agency and under review by the US Food and Drug Administration. Beyfortus and RSV data at IDWeek 2024 Thursday, October 17, 12:15-1:30 pm PT: RSV Prophylaxis with Nirsevimab in Infants: Systematic Review of Early Real-World Evidence on Effectiveness and Impact​ (Sanofi, presented by Oliver Martyn, MPH, Poster# P-631)Thursday, October 17, 12:15-1:30 pm PT: Implementation and Uptake of Nirsevimab within Nemours Children’s Health Delaware Healthcare System (independent study by Nemours Children's Health Delaware, presented by Sara Mann, Poster# P-633)Thursday, October 17, 1:15-2:00 pm PT Preventing RSV Lower Respiratory Tract Disease in Infants: The First Year in Review (Sanofi, Learning Lounge event)Thursday, October 17, 1:45-3:00 pm PT: Universal Immunization Strategy Against Respiratory Syncytial Virus (RSV) Prevention in Chile with Nirsevimab during the 2024 Winter Season: First Southern Hemisphere Nationwide Effectiveness Data (independent study by University of Chile, presented by Juan Pablo Torres-Torretti, MD, PhD, during the Late Breaker Abstract Session: Respiratory Viruses Across All Ages, #169).Friday, October 18, 12:15-1:30 pm PT: Significant Reduction in Disease Burden and a Shift in Clinical Diagnoses in Children Hospitalized with Respiratory Syncytial Virus (RSV) after Nirsevimab Implementation in Catalonia (Spain) (independent study presented by Anna Creus-Costa, MD, Poster# P-1186)Friday, October 18, 12:15-1:30 pm PT: The burden of respiratory syncytial virus among Brazilian infants (BONSAI study): preliminary results (Sanofi, presented by Manoel Ribeiro, MD, PhD, Poster# P-1199)Saturday, October 19, 12:15-1:30 pm PT: Nirsevimab in Patient Samples Does Not Interfere with Respiratory Syncytial Virus (RSV) Detection by Commercially Available Rapid Antigen Tests (AstraZeneca, presented by Sarah R. Sincero, BSc, Poster# P-2179) About RSVRSV is a highly contagious virus that can lead to serious respiratory illness for infants.1 Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday.1,2 RSV is the most common cause of lower respiratory tract disease, including bronchiolitis and pneumonia, in infants.3 It is also a leading cause of hospitalization in infants worldwide, with most hospitalizations for RSV occurring in healthy infants born at term.4-7 Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than 3 million hospitalizations in children younger than 5 years.8 RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017.9 About BeyfortusBeyfortus (nirsevimab) is the first immunization designed for all infants for protection against RSV disease through their first RSV season, including for those born healthy at term or preterm, or with specific health conditions. Beyfortus is also designed to protect children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. As a long-acting antibody provided directly to newborns and infants as a single dose, Beyfortus offers rapid protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system. Beyfortus administration can be timed to coincide with the RSV season. Beyfortus has been approved for use in the European Union, the US, China, Japan, and many other countries around the world. Special designations to facilitate expedited development of Beyfortus were granted by several regulatory agencies, including Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation and Fast Track Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and Beyfortus has been named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. References: U.S. Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www-cdc-gov.libproxy1.nus.edu.sg/rsv/high-risk/infants-young-children.html. Accessed August 2023.Walsh EE. Respiratory Syncytial Virus Infection: An Illness for All Ages. Clinics in Chest Medicine. 2017;38(1):29-36. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.ccm.2016.11.010.R K. Respiratory Syncytial Virus Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds Plotkin’s Vaccines 7th ed Philadelphia. 2018;7th ed. Philadelphia:943-9.Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32.McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of Perinatology: official journal of the California Perinatal Association. 2016;36(11):990-6.Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020;146:e20193611.Arriola CS, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9:587-595.Li Y, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022;399:92047–64.Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687. Attachment Press Release

SAN DIEGO, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the appointment of Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick G. Hayden, M.D., FACP to its Scientific Advisory Board (SAB). “We are honored that these four esteemed physicians and scientists have agreed to join our Scientific Advisory Board,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “They have already provided important guidance on the development of CD388 as we embark on our Phase 2b trial to test a single dose of CD388 to provide season-long protection against influenza A & B. We look forward to their continued guidance on pandemic preparedness, clinical and regulatory strategy, and infectious disease research.” Rick Bright, Ph.D. is an international expert on pandemic preparedness and response. In his most recent role as the Chief Executive Officer of the Pandemic Prevention Institute (PPI) at The Rockefeller Foundation, Dr. Bright led the development of the Foundation’s pandemic data-to-action platform that integrates modern technology, data analytics and global partners to help the world detect, prevent, and mitigate pandemic threats to achieve containment as quickly as possible. Dr. Bright serves as an international subject matter expert in biodefense, emergency preparedness and response, pharmaceutical innovation, vaccine, drug and diagnostic development and served as an advisor to the Biden Administration, the Coalition for Epidemic Preparedness Innovations (CEPI) and the National Academies of Sciences, Engineering & Medicine Forum on Microbial Threats. Dr. Bright received a Ph.D. in Immunology and Molecular Pathogenesis from Emory University and a B.S. magna cum laude in Biology and Physical Sciences from Auburn University at Montgomery. Philip Krause, M.D. has over 30 years of experience at the Food and Drug Administration, and a unique combination of scientific, regulatory, clinical, and public health experience. He is a long-time supporter of CASSS and WCBP, and co-chaired the meeting several times. He is trained as a physician with board certification in internal medicine and infectious diseases and a researcher with over 100 publications on topics spanning clinical evaluation of vaccines, viral pathogenesis and immunology, and biological product development. Dr. Krause is currently an independent consultant, providing strategic and regulatory advice related to biological product development. He recently served as deputy director of FDA’s Office of Vaccines Research and Review, where he led assessments of biological products for evaluation and licensure and helped to oversee the development and evaluation of all vaccines authorized and licensed in the US over the past 10 years. Mario Barro, Ph.D. is a Venture Partner and Head of the Infectious Disease Team at RA Capital Management, where he spearheads early-stage investment, company creation, and leads the Infectious Diseases team in advancing the company's evidence-based investment strategy. In this capacity, he collaborates closely with several portfolio companies, serving as a Board Member or Technical Advisor. With over three decades of experience in vaccinology, virology, and immunology across large pharma, government, academia, and biotech sectors, he brings a wealth of expertise to his roles. In addition to his work at RA Capital, Dr. Barro is the CEO and co-founder of GIVAX, a vaccine development startup focused on eradicating preventable Gastrointestinal infections in children and adults. As CEO, he drives the development of a novel groundbreaking vaccine solution aimed at addressing a critical unmet medical need. Dr. Barro completed his postdoctoral training at the NIH/NIAD and Mount Sinai School of Medicine and holds a PhD in microbiology from the University of Chile. Frederick Hayden, M.D., FACP is a Stuart S. Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine at the University of Virginia School of Medicine in Charlottesville, Virginia, USA. His principal research interests have been on respiratory viral infections with a particular focus on the development and application of antiviral agents for influenza, rhinovirus, and coronavirus infections. He has contributed to the development of seven influenza antivirals and two vaccines approved for clinical use in one or more countries. During the COVID-19 pandemic he collaborated with colleagues in China to conduct the first controlled trials of candidate antivirals in hospitalized patients and has served as a consultant to platform studies (UK CTAP, ACTIV, AGILE), academic groups, and industry regarding the selection of therapeutics for clinical trials. Dr. Hayden received his medical degree from Stanford University School of Medicine in 1973 and completed his clinical training in internal medicine and infectious diseases at Strong Memorial Hospital, University of Rochester, New York. About Cidara Therapeutics Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company plans to advance CD388 into a Phase 2b trial in the 2024 Northern Hemisphere influenza season. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which will be developed to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “believe,” “plan,” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to plans and timing for initiating a Phase 2b clinical trial for CD388. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, unanticipated impacts of the workforce reduction, difficulties in obtaining potential partners or other obstacles to clinical development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT:Brian RitchieLifeSci Advisors(212) 915-2578britchie@lifesciadvisors.com MEDIA CONTACT:Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com

The ketogenic diet has its fanatics and detractors among dieters, but either way, the diet has a scientifically documented impact on memory in mice. While uncovering how the high fat, low carbohydrate diet boosts memory in older mice, scientists identified a new molecular signaling pathway that improves synapse function and helps explain the diet's benefit on brain health and aging. The ketogenic diet has its fanatics and detractors among dieters, but either way, the diet has a scientifically documented impact on memory in mice. Whlie uncovering how the high fat, low carbohydrate diet boosts memory in older mice, Buck scientists and a team from the University of Chile identified a new molecular signaling pathway that improves synapse function and helps explain the diet's benefit on brain health and aging. Published in the June 5, 2024 issue of Cell Reports Medicine, the findings provide new directions for targeting the memory effects on a molecular level, without requiring a ketogenic diet or even the byproducts of it. "Our work indicates that the effects of the ketogenic diet benefit brain function broadly, and we provide a mechanism of action that offers a strategy for the maintenance and improvement of this function during aging," said the study's senior author, Christian González-Billault, PhD, who is a professor at the Universidad de Chile and director of their Geroscience Center for Brain Health and Metabolism, and adjunct professor at the Buck Institute. "Building off our previous work showing that a ketogenic diet improves healthspan and memory in aging mice, this new work indicates that we can start with older animals and still improve the health of the aging brain, and that the changes begin to happen relatively quickly," said John Newman, MD, PhD, whose laboratory at Buck collaborated with Dr. González-Billault on the study. Newman is both an assistant professor at the Buck Institute, and a geriatrician at University of California, San Francisco. "It is the most detailed study to date of the ketogenic diet and aging brain in mice." More than a century ago, researchers observed that rats that consumed less food lived longer. "We now know that being able to manipulate lifespan is not about specifically eating less," said Newman, but actually is related to signals inside cells that turn on and off specific pathways in response to available nutrients. Many of those pathways are related to aging, such as controlling protein turnover and metabolism. Some of those signals are the ketone bodies, which consist of acetoacetate (AcAc), β-hydroxybutyrate (BHB) and to a much lesser extent, acetone. These molecules are routinely produced in the liver. They ramp up when glucose is in short supply, whether due to caloric restriction, intense exercise or low carbohydrate intake, such as with a ketogenic diet. Seven years ago, Newman led a team that published the first proof of the concept that if a ketogenic diet exposes mice to increased levels of ketone bodies over much of their adult life, it helps them to live longer and age in a more healthy way. "The most striking effect on their health as they aged was that their memory was preserved; it was possibly even better than when they were younger," he said. The current study, designed to answer what part of the ketogenic diet was having the effect and how it was affecting the brain on a molecular level to improve memory, was led by González-Billault in a collaboration with scientists at the Buck. Mice on a ketogenic diet are fed a ratio of 90 percent calories from fat and 10 percent from protein, while mice on a control diet received the same amount of protein but only 13 percent fat. The test mice, of "advanced age" of more than two years old, received one week of the ketogenic diet, cycled with one week of the control diet, to keep the mice from overeating and becoming obese. The benefits of the ketogenic diet, said, González-Billault, were demonstrated through neurophysiological and behavioral experiments with the mice that test how well the mechanisms involved in memory generation, storage, and retrieval function in aged animals. When these showed that the ketogenic diet appeared to benefit how well the synapses responsible for memory worked, they took a deep dive into the protein composition at these synapses in the hippocampus, in a collaboration with Buck professor Birgit Schilling, PhD, who directs the Proteomics and Mass Spectrometry Center. "Surprisingly, we saw that the ketogenic diet caused dramatic changes in the proteins of the synapse," said Schilling. Even more surprising, she said, was that the changes started after a relatively brief exposure to the diet (tested after only one week on the diet) and only became more pronounced over time (tested again after six weeks and a year). Further testing indicated that in synapses, a particular signaling pathway (protein kinase A, which is critical to synapse activity) was activated by the ketogenic diet. In isolated cells, the team then showed that it appears that BHB, the main ketone body produced in a ketogenic diet, is activating this pathway. This leads to the idea, said González-Billault, that ketone bodies (specifically BHB) play a crucial role not only as an energy source, but also as a signaling molecule. "BHB is almost certainly not the only molecule in play, but we think this is an important part of understanding how the ketogenic diet and ketone bodies work," said Newman "This is the first study to really connect deep molecular mechanisms of ketone bodies all the way through to improving the aging brain." Looking forward, he said, the next step would be to see if the same memory protection could be achieved by using BHB alone, or possibly going even more targeted than that by manipulating the protein kinase A signaling pathway directly. "If we could recreate some of the big-picture effects on synapse function and memory just by manipulating that signaling pathway in the right cells," he said, "we wouldn't even need to eat a ketogenic diet in the end."