Gazi University

ACI SANT'ANTONIO, Italy, July 22, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company headquartered in Italy, is pleased to announce that the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA) has issued a positive opinion concerning Orphan Drug Designation (ODD) for polihexanide in the treatment of fungal keratitis. This designation follows the positive opinion of Committee for Human Medicinal Products (CHMP) adopted in May and the COMP positive opinion dated March 30 of this year for the medicinal product AKANTIOR® (polihexanide 0.08%) in the treatment of acanthamoeba keratitis. SIFI expects to receive the decision of the European Commission (EC) for marketing authorization in August. Polihexanide received an ODD in fungal keratitis from the US Food and Drug Administration (FDA) in February 2022. Fungal keratitis, a severe infection of the cornea caused by fungi such as Fusarium, Aspergillus, and Candida species, is a significant cause of ocular morbidity and unilateral blindness worldwide1. Although rare, this condition can lead to substantial vision loss if not treated promptly. Currently, no approved treatments exist for fungal keratitis in Europe, Japan, Asia, and most other regions globally. COMP's positive opinion concerning ODD for fungal keratitis is based on SIFI's in vitro, ex vivo and in vivo studies on standardized strains, demonstrating the efficacy of polihexanide against the most recurring species in fungal keratitis, such as Fusarium, Candida and Aspergillus. In vivo study were performed in collaboration with Gazi University (Ankara, Turkey). Additional studies on human ocular isolates are ongoing to potentially confirm the efficacy of polihexanide in fungal keratitis. SIFI plans to initiate clinical trials in patients affected by fungal keratitis in 2025. The company will seek Contract Research Organization (CRO) pitches for a Phase II clinical trial in Q4 2024. SIFI will focus its clinical development program on two major geographies, such as the USA and Europe. A potential CRO partner should demonstrate extensive experience in ophthalmology and rare diseases, and a global presence. "As we are preparing to launch AKANTIOR® (polihexanide 0.08%) in acanthamoeba keratitis across Europe, this COMP positive opinion concerning ODD for fungal keratitis reinforces our commitment to further invest on polihexanide and develop it in such rare disease where there is a high unmet medical need," said Fabrizio Chines, Chairman and CEO of SIFI. "We are eager to advance into the clinical development after encouraging preclinical data and double down on our efforts to develop therapeutic solutions for ophthalmic rare diseases." ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information is available at . ABOUT AKANTIOR®: AKANTIOR® (polihexanide 0.08%) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. The EC and the FDA granted SIFI Orphan Drug Designation in the treatment of acanthamoeba keratitis. CHMP opinion was received in May, EC decision is expected in August 2024. In addition, COMP confirmed the designated orphan medicinal product status at the time of marketing authorisation of Akantior (polihexanide). ABOUT FUNGAL KERATITIS: Fungal keratitis is a severe corneal infection that often results in blindness and eye loss. The disease is most prevalent in tropical and subtropical climates. According to The Lancet, annual global incidence of fungal keratitis is estimated at 1,051,787 cases, with the highest rates in Asia and Latin America. There are no approved treatments for fungal keratitis in Europe, Japan, Asia and almost anywhere else around the World. In addition to lack of approved medical alternatives, the incidence of fungal keratitis may be on the uptick due the global trend in general resistance to anti-fungal therapeutics. 1. AAO Fungal Keratitis – Europe EPIDEMIOLOGY Contact: Sabrina Zappia +39 3336999669 [email protected]

Acclaimed academic researcher has led 40+ multicenter phase 2 and phase 3 clinical studies CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the appointment of Professor Saadettin Kilickap, M.D. to its Scientific Advisory Board (SAB). This press release features multimedia. View the full release here: Professor Saadettin Kilickap, M.D., Scientific Advisor to MAIA Biotechnology (Photo: Business Wire) Dr. Kilickap is a professor at the Istinye University Faculty of Medicine, Department of Medical Oncology, Liv Hospital in Turkey. His research focuses on medical oncology and cancer epidemiology, including solid tumors such as lung cancer, breast cancer, melanoma, and gastrointestinal system cancers, as well as targeted therapies and immunotherapy. “Saadettin has served as principal or sub-investigator in more than 40 national and international multi-center phase 2 and phase 3 studies, many of which were related to lung cancer,” said Chief Executive Officer Vlad Vitoc, M.D. “He is a prominent voice on medical oncology and cancer epidemiology, with a special interest in quality of life for cancer patients. We are delighted to welcome him as Scientific Advisor as we begin to clear major clinical inflection points this year and progress with our groundbreaking cancer research.” Prior to his current appointment, Dr. Kilickap was a professor at the Preventive Oncology Department of Hacettepe University Cancer Institute of Turkey. Earlier he worked in the Department of Hematology-Oncology at Regensburg University in Germany and was a faculty member at the Sivas Cumhuriyet University Faculty of Medicine, Department of Internal Medicine, in Turkey. Dr. Kilickap graduated with honors from Gazi University Faculty of Medicine and went on to complete his internal medicine residency training at Hacettepe University Faculty of Medicine, both located in Ankara, Turkey. He completed his fellowship training at Hacettepe and became a medical oncology specialist in 2009. In the same year, he graduated from the Cancer Epidemiology Master's Program at the Hacettepe University Oncology Institute, Department of Preventive Oncology. Dr. Kilickap has authored more than 240 scientific articles published in international peer-reviewed journals, and delivered more than 50 poster presentations at international congresses. About MAIA Biotechnology, Inc. MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit . Forward Looking Statements MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

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.