University of Udine

ZUG, Switzerland, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, in collaboration with EURETINA, today announced the winner of the Inaugural Ramin Tadayoni Award. The Ramin Tadayoni Award was established in memory of Oculis’ Chief Scientific Officer and a world-renowned retina specialist in order to pay a lasting tribute to Professor Tadayoni’s legacy, who passed away unexpectedly earlier this year. The first recipient of the award is Andrea Govetto, M.D., Ph.D. who is developing a computational model of fluid flow and retinal tissue deformation in macular edema. Anat Loewenstein, M.D., President of EURETINA, added: “I would like to extend my thanks to all the applicants. We received over 50 robust and highly competitive submissions and on behalf of EURETINA, I would like to congratulate Dr. Govetto as the first recipient of this prestigious award. Dr. Govetto’s innovative research is focused on fluid flow and retinal tissue deformation in macular edema and is therefore a perfect tribute to Prof. Tadayoni’s achievement and contributions.” Riad Sherif, M.D., Chief Executive Officer of Oculis, commented: “We are honored to be part of the Ramin Tadayoni Award in partnership with EURETINA and wish to congratulate the winner, Dr. Govetto, a rising ophthalmologist dedicated to further advancing research for retinal diseases and improving patient care. We believe that by supporting this award and funding high-quality retina research, we will be able to honor our friend and colleague Prof. Ramin Tadayoni’s legacy.” Dr. Govetto is a vitreoretinal surgeon at the Oftalmico-Fatebenefratelli Hospital, ASST-Fatebenefratelli-Sacco in Milan, Italy. His research is focused on the pathology of the vitreoretinal interface and retinal detachment, contributing to the understanding of the pathophysiology of lamellar macular hole, epiretinal membrane, and tractional abnormalities of the central fovea, for which he was recognized with numerous awards. Dr. Govetto specialized in ophthalmology in Spain, completed his clinical and research fellowship in vitreoretinal diseases and surgery at the Stein Eye Institute of the University of California Los Angeles, and a surgical fellowship at the Bristol Eye Hospital in Bristol, U.K. He received his M.D. from the University of Udine, Italy and completed his Ph.D. at the University of Alcalà, Madrid, Spain. The annual award of €30,000 for research support, with an additional €5,000 for the awardee, recognizes the future generation of talented ophthalmologists who have demonstrated outstanding potential in the field of retina research. The award was presented to Dr. Govetto by Anat Loewenstein, M.D., President of EURETINA, at the opening ceremony of the EURETINA congress taking place September 19-22, 2024 in Barcelona, Spain. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; OCS-02 (licaminlimab), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a neuroprotective candidate for acute optic neuritis (AON). Headquartered in Switzerland and with operations in the U.S. and Iceland, Oculis’ goal is to improve the health and quality of life of patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis ContactsMs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor & Media Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com1-212-915-2577

Results from the clinical development programme developed with Protalix BioTherapeutics evaluating pegunigalsidase alfa (PRX-102) an investigational enzyme replacement therapy (ERT), support its potential as a treatment option for adult patients with Fabry disease. SPARKLE registry, Europe's first registry dedicated to collecting real-world evidence in patients with Alpha Mannosidosis, has enrolled more than 50 patients across Europe. Chiesi is sponsoring a satellite symposium, "What matters most? Improving care in LSDs," led by Maurizio Scarpa, M.D., Ph.D., Director of the Regional Reference Centre for Rare Diseases at Udine University Hospital, Italy. FREIBURG, Germany, Sept. 2, 2022 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research focused healthcare Group (Chiesi Group), today announced multiple presentations focused on the research and treatment of lysosomal storage diseases (LSDs) at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium being held in Freiburg, Germany 30 August – 2 September, 2022. The company's presentations include five abstracts with data from a robust clinical development programme evaluating pegunigalsidase alfa (PRX-102), an investigational enzyme replacement therapy (ERT) for the treatment of Fabry disease. The company is also presenting two abstracts dedicated to Alpha Mannosidosis, including updates from Europe's first patient registry for this ultra-rare disease. Finally, the company is sponsoring a satellite symposium, " What matters most? Improving care in LSDs," that is being led by Maurizio Scarpa, M.D., Ph.D., Director of the Regional Reference Centre for Rare Diseases at Udine University Hospital, Italy. "The multidisciplinary approach and the doctor-patient dialogue play a crucial role in providing the most appropriate and personalised therapeutic solutions in LSDs," said Prof. Scarpa. "Patients with lysosomal storage diseases, even within the same diagnosis, are very heterogeneous and can live with completely different conditions from each other. This is why fostering constant communication between patient and doctor is one of the best ways to understand which symptoms are most impactful and burdensome for patients, or to implement a more holistic approach that includes the management of associated conditions, such as psychological well-being and impaired mobility. Only in this way we will be able to work with ever greater specificity in order to achieve more incisive results in terms of improving the quality of life and well-being of people with lysosomal storage diseases." Today, some 350 million people are living with a rare disease. There are more than 7,000 known rare diseases 1, but only five percent currently have an approved treatment or an experimental therapy in development. Chiesi Global Rare Diseases was established in 2020 to bring innovative solutions to these patients and support to their caregivers. Drawing maximum synergy from the resources and capabilities of the Chiesi Group and its global network, the business unit develops innovative drugs with the patients' needs first. The company's symposium at SSIEM 2022 is dedicated to the key role of the patient as a driving force for a personalised and multidisciplinary diagnostic, therapeutic and social approach in the treatment of lysosomal storage diseases. During this symposium, leading international opinion leaders including Dr. Uma Ramaswami, a paediatrician specialised in hereditary metabolic diseases at the Royal Free Hospital in London (UK), Dr. Nathalie Guffon, Head of Reference Centre for Inherited Metabolic Diseases at the Femme Mère Enfant Hospital in Lyon (France), and Dr. Patricio Ricardo da Terra Aguiar, a specialist in hereditary metabolic diseases at Lisbon North Hospital Center (Portugal), will review the importance of patient centricity and listening, how to choose the most appropriate therapy according to specific needs, and how to assess the effects of treatment and adherence to therapy. The event is focused on Fabry disease and Alpha Mannosidosis, the latter being an ultra-rare disease with still limited knowledge available in the scientific literature so far. Chiesi Global Rare Diseases is working together with the scientific community to increase awareness and knowledge of this ultra-rare condition. "We are constantly working to promote research and development of new products for rare and ultra-rare diseases because we firmly believe that by helping patients and their families, we can play our part in generating a positive impact on society as a whole," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. "Being able to promote discussion within the scientific community on the importance of the patient centricity first and foremost as a person, makes us proud to be here today. In our DNA we feel a strong desire to be able to bring answers to those needs that are still unmet, as in the case of Fabry disease, and at the same time to cooperate with physician and patient advocacy groups in building together the story of ultra-rare diseases, such as Alpha Mannosidosis, which is still largely unknown." "Moreover, as a B-Corp certified company, Chiesi is strongly committed to making a tangible contribution to the United Nations Sustainable Development Goals (SDGs), and more specifically in the field of rare diseases, to the goal of achieving health for all at all ages," added Giacomo Chiesi. "Chiesi Global Rare Diseases wants to play its part in achieving this goal by committing on a daily basis to providing patients with safe and effective solutions that improve their quality of life and by making these treatments accessible to those in difficult circumstances or who cannot easily access treatment." Data presented at SSIEM 2022: Fabry Disease Chiesi is presenting results from the Phase III clinical development programme sponsored by Protalix Ltd., Chiesi's collaboration partner, evaluating PRX-102, including data from the BRIGHT and BALANCE studies. The results of the Phase III BRIGHT2 study indicate that treatment with 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks for 52 weeks was well tolerated and that Fabry disease remained stable throughout the duration of the study. The pivotal Phase III BALANCE3 study, which is an active-control, randomised, double-blind, 24-month study in adult Fabry disease patients with renal function impairment, evaluated the safety and efficacy of 1 mg/kg of PRX-102 administered every two weeks versus agalsidase beta at the same dosing schedule. The study enrolled 78 patients previously treated with agalsidase beta for at least one year and met the predefined criteria of non-inferiority for the primary endpoint of renal function. Alpha-Mannosidosis Velmanase Alfa, a drug authorised by the EMA in 2018, is the first drug therapy for the treatment of Alpha Mannosidosis, an ultra-rare and severely disabling genetic disease. It is an ERT that aims to replace or supplement natural alpha-mannosidase. Chiesi and the scientific community are working together to build a diagnostic and therapeutic pathway that meets the needs of patients: The company is presenting for the first time at SSIEM 2022 preliminary data from the SPARKLE registry, the first European registry dedicated to collecting real-world evidence in patients with Alpha Mannosidosis. The registry was developed to gather insights into the natural history of the disease regardless of treatment. The registry has been active since December 2019 and has so far enrolled more than 50 patients in different European countries. The goal is to reach 100 patients in order to be able to build more knowledge on the natural history of the disease, as well as on the impact of long-term enzyme replacement therapy with velmanase alfa. Furthermore, the company is presenting long-term efficacy data of velmanase alfa for the treatment of alpha-mannosidosis, from the French Etoile Alpha registry. This is the longest clinical experience to date, with data from patients who received velmanase alfa treatment up to a maximum of 9.5 years. The study shows not only significant improvements in biochemical parameters and lung function but also improvements in motor function. About Fabry Disease Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α‑Galactosidase‑A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α‑Galactosidase‑A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system. About Alpha-Mannosidosis Alpha-mannosidosis is a lysosomal storage disease that belongs more specifically to the subgroup of oligosaccharidoses. It is a hereditary disease, with autosomal recessive transmission, due to a mutation in the gene MAN2B1. This specific genetic defect causes deficiency of the lysosomal alpha-mannosidase enzyme, resulting in harmful and progressive build-up of oligosaccharides (sugars) in cells throughout the body. The manifestations of alpha-mannosidosis vary from patient to patient, but the disease is essentially characterised by immunodeficiency, skeletal abnormalities, facial dysmorphisms, sensorineural deafness and gradual deficits in mental and speech functions. Related motor disorders include muscle weakness, osteo-articular abnormalities and ataxia. Additional symptoms include hydrocephalus, hepatosplenomegaly and eye, kidney and heart problems. Alpha-Mannosidosis affects about one in every 500,000 live births. About Pegunigalsidase Alfa (PRX-102) Pegunigalsidase alfa (PRX-102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant alpha-galactosidase A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX-102 has been observed to have a circulatory half-life of approximately 80 hours. Protalix Ltd., Chiesi's collaboration partner, designed PRX-102 to potentially address the continued unmet clinical need in Fabry patients. About Velmanase Alfa The active ingredient velmanase alfa is part of a group of drugs called enzyme replacement therapies and is the first drug therapy for the treatment of alpha-mannosidosis, an ultra-rare and severely disabling genetic disease caused by the absence or malfunction of alpha-mannosidase, an enzyme involved in the cellular breakdown of glycoproteins. Velmanase alfa is a recombinant form of the human alpha-mannosidase enzyme. Velmanase alfa is an investigational drug candidate in the United States. The effectiveness and safety of Velmanase Alfa have not been reviewed or approved by the FDA. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit . About Chiesi Group Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company's mission is to improve people's quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi's commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. Since 2019, Chiesi is the world's largest biopharmaceutical group to be certified B Corp, meaning that its sustainability efforts are measured and assessed by the most ambitious global standards. The company aims at becoming net-zero by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 30 countries, and counts more than 6,000 employees. The Group's research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit 1 Osservatoriomalattierare.it 2 3 Chiesi Global Rare Diseases Media Contact Jenna Urban Berry & Company Public Relations +1-212-253-8881 [email protected] SOURCE Chiesi Global Rare Diseases

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced the formation of a Global Steering Committee (GSC) to guide the pivotal Phase 3 global clinical development program of Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C (NPC). As the Global Principal Investigator for the TransportNPC™ study, Caroline Hastings, MD serves as the senior scientific and clinical expert for the trial and will also chair the GSC. “Dr. Caroline Hastings, global principal investigator for TransportNPC™ and chair of the GSC, has been instrumental in assembling this high caliber Global Steering Committee with representation of renowned Key Opinion Leaders and clinical experts in NPC. It is another testimony of our commitment to serve the NPC community and deliver on the unmet medical needs. I feel humbled and privileged to be working with this outstanding group of professionals who are committed to advance science and clinical trials that can bring hope and treatment benefits to so many patients and their families,” commented Lise Kjems, MD, PhD, Chief Medical Officer of Cyclo Therapeutics. The Company’s ongoing pivotal Phase 3 study, TransportNPC™, is a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the safety, tolerability, and efficacy of 2,000 mg/kg doses of Trappsol® Cyclo™ administered intravenously and standard of care (SOC), compared to placebo administered intravenously and SOC alone, in patients with NPC1. The Phase 3 study intends to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1 in at least 23 study centers in 9 countries. Eligible patients will be randomized 2:1 to receive either Trappsol® Cyclo™ or a placebo. Randomization will not be constrained based on patient age, nor will patient enrollment be gated by patient age. The study duration is 96 weeks and includes an interim analysis at 48 weeks. Dr. Hastings, Global Principal Investigator for the TransportNPC™ trial and member of Cyclo Therapeutics’ Scientific Advisory Board added, “I am very grateful by the overwhelmingly positive responses as I reached out to fellow scientists and physicians to invite them to join the Global Steering Committee. I am honored to be working alongside these wonderful colleagues with outstanding knowledge and expertise and who represent the excellent investigators taking part in the TransportNPC™ trial. Together, we have a very unique opportunity to further refine the scientific strategy for Trappsol® Cyclo™ and help drive this important program toward potential approval.” “NPC is a devastating neurodegenerative disease that needs more effective therapies. Given the clinical course and progressive nature of this disease, novel therapeutic strategies with the potential for disease modifying effects are necessary. The TransportNPC™ trial is unique as it is designed to demonstrate the long-term clinical benefits and potential for disease modification,” commented Professor Roberto Giugliani, MD, PhD. “I have been caring for patients with NPC for more than 25 years. These patients urgently need better treatment options that will better halt the cruel, neurodegenerative course that this disease takes. In this study with cyclodextrin intravenously, I see an opportunity to improve the therapeutic offer,” added Dr. Eugen Mengel. The members of the TransportNPC™ Global Steering Committee are: Professor Caroline Hastings, MD is the Chair of the Phase 3 Trappsol® Cyclo™ Program Steering Committee, and the Global Principal Investigator for the Company’s ongoing TransportNPC™ study evaluating Trappsol® Cyclo™ for the treatment of NPC. Dr. Hastings currently serves as the Pediatric hematologist oncologist, Director of Neuro-oncology, and Professor of Pediatrics at UCSF Benioff Children’s Hospital Oakland and is an advisor to U.S. and Australian NPC Advocacy organizations and to physicians globally on NPC. She has been practicing in the field of Pediatric Hematology Oncology since 1992 and has served as the director of the fellowship program at the Children’s Hospital & Research Center Oakland since 1996. She has devoted herself to her patients and to fostering education in this specialty. Her academic interests include tumors of the brain and spinal cord, relapsed acute lymphoblastic leukemia, and lysosomal storage diseases including Niemann Pick Type C disease. Professor Mark Walterfang MBBS Hons, PhD, FRANZCP is a consultant psychiatrist at the Adult Mental Health Rehabilitation Unit at Sunshine Hospital and a consultant neuropsychiatrist at the Royal Melbourne Hospital Neuropsychiatry Unit. Dr. Walterfang has been involved in the development in a number of clinical tools for use in psychiatric patients in the areas of cognition and behavioral observation, and their validation in a variety of medical, neurological and psychiatric settings since 2000. His continuing research involves the neuroimaging and neuropsychiatric investigation of neurometabolic disorders including phenylketonuria and NPC, and in shape analysis of cortical and subcortical regions in neurodegenerative disorders. He has published over 170 Medline-indexed scientific papers, and recently contributed a new chapter on the Neuropsychiatry of Neurometabolic and Neuroendocrine Disorders to the world's most respected reference text in psychiatry, Kaplan and Sadock's "Comprehensive Textbook of Psychiatry". Professor Maurizio Scarpa, MD, PhD, Paediatrician is the Founder and President of the Brains for Brain Foundation, a Pan-European task force on brain and neurodegenerative diseases. He is Professor of Paediatrics at the Department of Women’s and Children’s Health, University of Padova, Italy and the Director, Coordinating Center for Rare Diseases, Udine University Hospital, Udine, Italy. Professor Scarpa has extensive expertise as a basic scientist in genetics and biotechnology, and as a clinician in the diagnosis and treatment of paediatric rare disorders, neurometabolic diseases in particular. He is especially interested in developing innovative health approaches for the diagnosis and the treatment of metabolic inherited diseases. Professor Scarpa has published about 140 international peer reviewed clinical and scientific papers, book chapters and reviews. Professor Scarpa is the Coordinator of the European Reference Network for Inherited Metabolic Diseases (MetabERN). Dr. Eugen Mengel is the principal investigator, and the founder and CEO of the SphinCS GmbH & SphinCS Lyso non-profit UG. Dr. Mengel has dedicated himself to research in the field of lysosomal diseases and has already significantly contributed to the advancement of this field of study. He is the co-author of 129 peer-reviewed publications with focuses on Gaucher disease, NPC and Pompe disease and is an active member of the Society for the Study of Inborn Errors of Metabolism (SSIEM), European Study Group on Lysosomal Diseases (ESGLD) and European Working Group on Gaucher Disease (EWGGD). Orna Staretz-Chacham, MD is a neonatologist, metabolic specialist and senior lecturer at the Faculty of Health Sciences, Ben-Gurion University of the Negev, Israel. For years Dr. Staretz-Chacham has worked in the field of inherited metabolic disorders with a focus on neonate and leads the Center for Rare Disease in Soroka Medical Center in since 2021. Among the many critical contributions stemming from her research is characterization of the pulmonary pathologies in Niemann-Pick C1 and most recently in lysosomal patients with COVID-19. Dr. Staretz-Chacham is regarded as one of most prominent clinical experts in the clinical pulmonary presentations in patients with NPC. Dr. Staretz-Chacham has been involved in clinical trials with Trappsol® Cyclo™ from early on and has significant experience in treating patients with NPC. Her commitment to clinical research is evidenced by the more than 40 published articles in peer-reviewed journals in the field of inherited metabolic diseases. Loren DM Pena, MD, PhD is a Clinical Geneticist, Division of Human Genetics, and Associate Professor, Department of Pediatrics at Cincinnati Children’s Hospital Medical Center. As a clinical geneticist, Dr. Pena works with children who have rare and orphan diseases, lysosomal storage disorders and metabolic disorders, and also works in neurogenetics and gene discovery. Dr. Pena has made noteworthy contributions to the field through her research as a lead faculty member for clinical trials in genetics and leading several clinical trials for rare conditions. Professor Roberto Giugliani, MD, PhD is a medical geneticist with specialization in inherited metabolic diseases. He is Full Professor at Department of Genetics of the Federal University of Rio Grande do Sul and active member of the Medical Genetics Service of HCPA (University hospital), Brazil. He is also Coordinator of the Brazilian Institute of Population Medical Genetics, Editor-in-Chief of the Journal of Inborn Errors of Metabolism and Screening, Chairman of the Latin American School of Human and Medical Genetics, Member of Brazilian Academy of Sciences, Head of Rare Diseases of DASA/GeneOne, and co-founder of House of Rares. He is the past President of the Latin American Society of Inborn Errors of Metabolism and Newborn Screening, the Latin American Network of Human Genetics (RELAGH), and the Brazilian Society of Medical Genetics. Professor Giugliani’s main interests are concentrated in screening, diagnosis, and treatment of IEM, having supervised the training of over 100 MSc/PhDs, and authoring of over 500 scientific papers. Professor Dr. Fatih Ezgü is a Professor of Pediatrics and Head of the Department of Pediatric Genetics at Gazi University, Faculty of Medicine, Department of Pediatrics in Ankara, Turkey. He is also on faculty at the Department of Pediatric Metabolic Disorders at the same institution. Professor Ezgü has worked in the field of inborn metabolic and genetic diseases for 21 years and has published over 100 articles in peer-reviewed journals. His primary interests are lysosomal disorders, mitochondrial disorders, clinical dysmorphology and genetic and metabolic bone disease and novel treatments for genetic disorders. Dr. Ezgü is the vice chairman of the Phase 1 Clinical Trials Center for Genetic Diseases at Gazi University. Cyclo Therapeutics received Orphan Drug Designation for Trappsol® Cyclo™ to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S. The Rare Pediatric Disease Designation is one of the chief requirements for sponsors to receive a Priority Review Voucher in the U.S. upon marketing authorization. About Cyclo Therapeutics Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease. The Company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is the subject of four formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, ( NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is planning an early phase clinical trial using Trappsol® Cyclo™ intravenously in Alzheimer’s Disease based on encouraging data from an Expanded Access program for late-onset Alzheimer’s Disease (NCT03624842). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. Safe Harbor Statement This press release contains “forward-looking statements” about the company’s current expectations about future results, performance, prospects and opportunities, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company’s future performance include the company’s ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company’s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company’s filings with the Securities and Exchange Commission, including, but not limited to, the company’s reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.