Univentricular Heart

FORT LEE, N.J., March 1, 2024 /PRNewswire/ -- Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial. The company is pleased to announce Dr. Rahul Rathod, a pediatric cardiology specialist and leader with over 20 years of experience at Boston Children's Hospital, as the Global Principal Investigator of FUEL-2. Continue Reading FUEL-2 Dr. Rathod currently serves as the Associate Chair of Cardiology, Director of the Single Ventricle Program, and Director of the Fontan Clinic at Boston Children's Hospital as well as Associate Professor of Pediatrics at Harvard Medical School. He is an internationally recognized medical expert, researcher, and key opinion leader in the single ventricle heart disease space and Fontan circulation—with more than 80 peer-reviewed publications. Dr. Rathod is the Founder and Executive Director of the Fontan Outcomes Registry Using CMR Examinations (FORCE). The FORCE Registry is a tech-enabled research platform dedicated to improving the quality and longevity of life for single ventricle patients by aggregating global Fontan data, advancing cardiac imaging through big data and analytics, and utilizing machine learning to improve workflows and patient outcomes. FORCE is the largest Fontan dataset in the world. As the Global Principal Investigator for FUEL-2, Dr. Rathod will lead the clinical trial, overseeing clinical protocol, conduct, and operations at all study sites. He will also lead the study analysis and contribute to reporting the results to the Food and Drug Administration (FDA). "FUEL-2 represents a pivotal moment in Fontan research pioneering advancements for our patients. This landmark study delves into the potential of udenafil to empower individuals to reclaim vitality in their daily lives," said Dr. Rathod about the trial. "The Fontan population is one with significant medical complexities and unmet needs; this trial offers the promise of tangible solutions and a powerful tool that can redefine the treatment landscape for Fontan patients." "Dr. Rathod is a preeminent expert in Fontan physiology and the ideal clinical leader to serve as the Global Principal Investigator of FUEL-2. Mezzion is very proud and encouraged to have him as our partner as this pivotal clinical trial progresses," said Dr. John Hariadi, Chief Medical Officer and Senior Vice President of Global Regulatory Affairs at Mezzion. Dr. Hariadi recently joined Mezzion from Johnson & Johnson, where he was senior director for global regulatory affairs. He previously served in several senior medical leadership roles at the FDA and the United States Department of Homeland Security. He will serve as Mezzion's primary liaison to the FUEL-2 clinical research organization, study sites, and investigators. FUEL-2 is a Mezzion Pharmaceuticals-sponsored clinical trial investigating the clinical efficacy and safety of udenafil in teenagers 12-18 years of age who have undergone the Fontan procedure. It is poised to be the world's largest Fontan clinical trial and is set to enroll 438 patients globally. Currently, 22 sites in the U.S. are enrolling or will begin enrolling in the coming weeks. The latest site information for FUEL-2 can be found here. Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor and was previously studied in some adolescents with Fontan physiology. PDE5 inhibitors relax the blood vessels and may increase the blood flow to the lungs. This may mean higher blood oxygen levels; if so, individuals may be less tired when exercising or during everyday activities. For more information about the study, please visit FUEL2study.com. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., has an administrative office in Fort Lee, New Jersey. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media Contacts: PR Contact – Philicia Thompson, [email protected], 7047749643 Medical Contact – John Hariadi, [email protected], (443) 699-6746 Mezzion Pharma Co. Ltd. Contact – S.I. Noh, [email protected], +82 2 560 8000 SOURCE Mezzion Pharmaceuticals, Inc

New Study Exposes Bovine Fortification Protocol Is Hurdle to Advancing the Standard of Care, Questions Feasibility of Randomized Controlled Trials in Vulnerable Premature Infant Population DUARTE, Calif., Feb. 6, 2024 /PRNewswire/ -- Optimizing nutrition for premature infants remains an important focus in neonatal care. More than 20 peer-reviewed studies of 5,000+ preterm infants demonstrated that, compared to bovine milk-based fortifiers (BMBF), Prolacta Bioscience's human milk-based fortifiers (HMBF) improve growth and development1-7 and provide clinically significant reductions in comorbidities.1,2,8-20 The health benefits from the use of HMBF have also shown significant annual cost savings for hospitals.8 More than 100,000 critically ill and preterm infants have received Prolacta's human milk-based nutritional products.21 Prolacta's Exclusive Human Milk Diet (EHMD) Protocol, introduced in 2022, is based on data showing that hospitals with the best outcomes start fortification as early as day one and advance feeds quickly.1,7,22 Yet, in contrast to this protocol and more than a decade of extensive clinical evidence, two small randomized controlled trials (RCTs) — Jensen with 228 infants and O'Connor with 127 infants — found no statistically significant difference in mortality and morbidity when comparing HMBF to BMBF. While the RCTs were intended to provide a head-to-head comparison between fortifier products, the feeding protocols fundamentally differed. HMBF recommendations for best outcomes regarding the day fortification should begin and the speed at which feeds are advanced were not followed in either study. Both RCTs were designed more than six years ago with fortification protocols intended to mitigate the risks of BMBF, which is known to cause feeding intolerance and severe complications in preterm infants, including sepsis and necrotizing enterocolitis (NEC), a leading cause of preemie death.23 Ethical Boundaries Limit RCT Feasibility The ability to fortify early and advance feeds quickly with HMBF raises an important ethical issue for RCT design. The known risks of BMBF established the decades-old standard of care in the neonatal intensive care unit (NICU) to delay fortification until preterm infants can tolerate the risks of the foreign protein. Given these known risks, randomizing extremely premature infants to day-one fortification with BMBF would unjustly endanger this vulnerable patient population. In seeking to mitigate BMBF's risk, the protocols used in the RCTs demonstrated severely delayed EHMD implementation, thus reducing the observable EHMD benefits. Yet, despite feeding protocols that were incongruent with established EHMD guidelines, both the RCTs showed lower morbidity and mortality rates for infants in the HMBF arms, which are clinically significant findings: While significantly underpowered, the Jensen study showed the HMBF death rate was 47% lower than BMBF.24 After adjusting for gestational age, the HMBF group in the Jensen study had decreased odds of bronchopulmonary dysplasia (BPD) at 36 weeks (p = 0.049).24 The O'Connor study demonstrated a 50% reduction in late-onset sepsis and a statistically significant reduction in retinopathy of prematurity (ROP) in infants receiving HMBF.13 "As clinicians, we must review studies with a critical lens and truly consider the body of evidence on topics critical to the well-being of our patients," said Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer for Prolacta. "I am convinced about the advantages of HMBF for critically ill and premature babies because I witnessed the impact with my own patients in Baltimore. What began as an initiative to decrease the incidence of NEC in our unit quickly became a unit-wide initiative to provide a clearly superior standard of care." Real-World Evidence Demonstrates Improved Outcomes and Reduced Costs Extensive real-world data affirm EHMD adoption enables critical health improvements for premature infants and major cost reductions for hospitals. Analysis of 2019-2022 data from 3,000+ patients at 60+ U.S. hospitals found EHMD implementation improved health outcomes and reduced costs, generating a 2.6X dollar-for-dollar return on investment.25 Similarly, a 2023 peer-reviewed report found EHMD implementation resulted in annual cost savings of $500,000 to $3.4 million per hospital from a reduction in comorbidities and shorter lengths of stay among very low birth weight infants.8 The body of real-world evidence in support of HMBF is substantial. It has been clinically proven in more than 20 peer-reviewed clinical studies that compared to BMBF, HMBF when used as part of an Exclusive Human Milk Diet demonstrated: Lower mortality and morbidity14,16,19 Reduced incidence of feeding intolerance15 Achieved adequate growth1,2,7 Reduced incidence of BPD1,12,14,15 Reduced incidence of ROP12,14,15 Reduced late-onset sepsis incidence and evaluations12-14 Reduced risk of NEC14,15,20 Improved long-term outcomes such as neurodevelopment4,5 Shortened stays in the NICU15 Reduced hospital costs8,15,25,26 Achieved better growth in term infants recovering from surgery for single ventricle physiology (SVP)27 and congenital gastrointestinal disorders (CGIDs)28 About Prolacta Bioscience Prolacta Bioscience® is a global life sciences company dedicated to Advancing the Science of Human Milk® to improve health outcomes for critically ill and premature infants. More than 100,00021 extremely premature infants worldwide have benefited from Prolacta's human milk-based products, which have been evaluated in more than 20 peer-reviewed clinical studies. Hospitals adopting Prolacta's Exclusive Human Milk Diet realize a 2.6X return on investment.25 Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta maintains the industry's strictest quality and safety standards, with over 20 validated tests for screening and testing human milk. Prolacta's manufacturing process uses vat pasteurization to ensure pathogen inactivation while protecting nutritional composition and bioactivity. Learn more at , on X, Instagram, Facebook, and LinkedIn. Media Contact: Loren Kosmont [email protected] 310-721-9444 References Huston R, Lee M, Rider E, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk-based fortifier. J Neonatal Perinatal Med. 2020;13(2):215-221. doi:10.3233/NPM-190300 Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054 Gates A, Thompson AB, Marin T, Waller JL, Patel J, Stansfield BK. Novel multinutrient human milk-based human milk fortifier promotes growth and tolerance in premature infants. J Parenter Enteral Nutr. 2022;46(4):817-827. doi:10.1002/jpen.2249 Bergner EM, Shypailo R, Visuthranukul C, et al. Growth, body composition, and neurodevelopmental outcomes at 2 years among preterm infants fed an exclusive human milk diet in the neonatal intensive care unit: a pilot study. Breastfeed Med. 2020. 15(5):304-311. doi:10.1089/bfm.2019.0210 Rahman A, Kase J, Murray Y, et al. Neurodevelopmental outcome of extremely low birth weight infants fed an exclusive human milk diet is not affected by growth velocity. Breastfeed Med. 2020;15(6):362-369. doi:10.1089/bfm.2019.0214 Sandhu A, Fast S, Bonnar K, Baier RJ, Narvey M. Human-based human milk fortifier as rescue therapy in very low birth weight infants demonstrating intolerance to bovine-based human milk fortifier. Breastfeed Med. 2017;12(9):570-573. doi:10.1089/bfm.2017.0017 Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants ≤ 1250 grams birth weight. BMC Res Notes. 2013;6:459. Published 2013 Nov 13. doi:10.1186/1756-0500-6-459 Swanson JR, Becker A, Fox J, et al. Implementing an exclusive human milk diet for preterm infants: real-world experience in diverse NICUs. BMC Pediatr. 2023;23(1). doi.org/10.1186/s12887-023-04047-5 Osmanova M, Müller MJ, Habisch B, Hippe A, Seeliger S. Nutrition of infants with very low birth weight using human and bovine based milk fortifier: benefits and costs. Neonat Pediatr Med. 2021;S10:003. Hanford J, Mannebach K, Ohler A, Patten M, Pardalos J. Rates of comorbidities in very low birth weight infants fed an exclusive human milk diet versus a bovine supplemented diet. Breastfeed Med. 2021;16(10):814-820. doi:10.1089/bfm.2020.0345 Carome K, Rahman A, Parvez B. Exclusive human milk diet reduces incidence of severe intraventricular hemorrhage in extremely low birth weight infants. J Perinatol. 2021;41(3):535-543. doi:10.1038/s41372-020-00834-5 Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet. Adv Neonatal Care. 2019;19(6):460-467. doi:10.1097/ANC.0000000000000676 O'Connor DL, Kiss A, Tomlinson C, et al. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial [published correction appears in Am J Clin Nutr. 2019 Aug 1;110(2):529] [published correction appears in Am J Clin Nutr. 2020 May 1;111(5):1112]. Am J Clin Nutr. 2018;108(1):108-116. doi:10.1093/ajcn/nqy067 Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet [published correction appears in Breastfeed Med. 2017 Dec;12 (10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134 Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168 Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024 Herrmann K, Carroll K. An exclusively human milk diet reduces necrotizing enterocolitis. Breastfeed Med. 2014;9(4):184-190. doi:10.1089/bfm.2013.0121 Huston RK, Markell AM, McCulley EA, et al. Decreasing necrotizing enterocolitis and gastrointestinal bleeding in the neonatal intensive care unit: the role of donor human milk and exclusive human milk diets in infants ≤1500 g birth weight. Infant Child Adolesc Nutr. 2014;6(2):86-93. doi:10.1177/1941406413519267 Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592-1595.e1. doi:10.1016/j.jpeds.2013.07.011 Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-7.e1. doi:10.1016/j.jpeds.2009.10.040 Data on file; estimated number of infants fed Prolacta's products from January 2007 to August 2023. Salas AA, Gunawan E, Nguyen K, et al. Early human milk fortification in infants born extremely preterm: a randomized trial. Pediatrics. 2023;152(3):e2023061603. doi:10.1542/peds.2023-061603 Ginglen JG, Butki N. Necrotizing Enterocolitis. StatPearls Publishing [Internet]. 2023. Available from: Jensen GB, Domellöf M, Ahlsson F, Elfvin A, Navér L, Abrahamsson T. Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk: a randomised controlled trial. eClinicalMedicine. 2023. . 1016/j.eclinm.2023. 102375 Data on file; hospital-provided outcomes analysis from 2019 to 2022. Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012;7(1):29-37. doi:10.1089/bfm.2011.0002 Blanco CL, Hair A, Justice LB, Roddy D, Bonagurio K, Williams PK, Machado D, Marino BS, Chi A, Takao C, Gordon EE, Ashrafi A, Cacho N, Pruetz JD, Costello JM, Cooper DS, & Cardiac Neonate Nutrition Study Group. A randomized trial of an exclusive human milk diet in neonates with single ventricle physiology. J Pediatr. 2022;256: 105–112. doi.org/10.1016/j.jpeds.2022.11.043 Karpen, H. Impact of an exclusive human milk diet in neonates with congenital gastrointestinal disorders: initial clinical results. Oral presentation at ISHMSI, Vienna, 2022 available at: SOURCE Prolacta Bioscience

SEOUL, South Korea, Feb. 21, 2023 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA). In the Type B meeting between the FDA and Mezzion, the FDA provided Mezzion with a clear path forward to FDA approval for the treatment of Fontan subjects with udenafil. In the Type B meeting, an agreement was reached with the FDA regarding its requirement for a confirmatory Phase 3 clinical trial. Mezzion reports that it has submitted a new protocol for the FUEL-2 Trial to the Division of Cardiology and Nephrology consistent with the agreement reached with the FDA in Type B meeting. The cardiovascular efficiency of the Fontan subjects deteriorates through adolescence and into adulthood. This deterioration correlates with a decline in exercise capacity and an increase in the prevalence of heart failure symptoms, hospitalization and mortality. Mezzion believes that the FUEL-2 confirmatory trial in Fontan subjects will show that chronic udenafil therapy will improve their exercise capacity and thus potentially prolong the time to the onset of serious morbidity. The protocol for the FUEL-2 Trial is based on what was learned from the original Phase 3 trial FUEL Trial and the agreement reached with the FDA. The study population will be single ventricle heart disease subjects with Fontan palliation and Fontan physiology who will most likely improve their exercise capacity based on their baseline cardiopulmonary exercise testing performance. Under the revised inclusion/exclusion criteria, FUEL-2 will exclude those target subjects who are defined as "Super Fontans." The Ad Hoc analysis of a similar population of about 300 subjects excluding the Super Fontans in the original FUEL trial, comparing the mean peak VO2 of the udenafil treated group of about 150 subjects versus the placebo group of also about 150 subjects was statistically significant at a p-value of 0.023. The important secondary endpoints of exercise capacity at the Ventilatory Anaerobic Threshold ("VAT"), Work Rate, Oxygen Consumption at VAT and Ventilatory Efficiency will also be evaluated. These secondary endpoints were all statistically significant for the entire treatment arm, about 200 subjects, in the FUEL Trial. FUEL-2 is designed as a double-blind, placebo-controlled trial with a sample size of approximately 400 subjects. The primary efficacy endpoint is the change in peak oxygen consumption (VO2 mL/kg/min) from Baseline to Week 26, as measured by maximal cardiopulmonary exercise testing. As agreed with the FDA, the statistical criteria for success will be at a 2-sided level of significance of 10% (p<0.1). An interim analysis will be conducted when approximately 50% of the subjects complete the trial to determine what final sample size is needed to meet the statistical criteria of a 2-sided alpha of 0.1 at 90% power. Because the principal objective of FUEL-2 is to obtain statistical significance of the primary end point, FUEL-2 will have fewer procedures compared to the FUEL Trial. Mezzion therefore believes that the FUEL-2 protocol is simpler and more straightforward than the FUEL Trial protocol. Mezzion also believes that the FUEL-2 protocol will be more convenient for the subjects, it will facilitate and expedite the clinical operation at the site level, and it will streamline the enrollment and recruitment process. Approximately 30 sites throughout the world will participate in the new FUEL-2 confirmatory trial. Study enrollment is expected to be initiated within the next few weeks. About the Fontan Procedure and Subsequent Expectations The Fontan procedure is a surgical intervention that allows for the survival of children born with congenital heart disease characterized by only a single functional pumping chamber. This procedure consists of re-configuring the circulation to allow the single ventricle to pump blood to the body while connecting the great veins directly to the arteries that bring blood to the lungs. In this "Fontan circulation" the blood returning from the body bypasses the heart and travels to the lungs without the assistance of a dedicated right ventricle pumping chamber. The goal of the Fontan procedure is to separate the systemic and pulmonary circulations and to improve oxygen levels by redirecting venous blood directly to the lungs. While the Fontan procedure creates a stable circulation, the risk of hospitalization and cardiac death rises significantly in the second and third decades after Fontan completion, a risk that is associated with a decline in exercise capacity. The Fontan circulation is also associated with non-cardiac complications such as protein-losing enteropathy, plastic bronchitis, and liver failure, all of which can be attributed to a chronic elevation in central venous pressure and a chronically reduced cardiac output. For all of these reasons, a 35-year-old patient who has gone through Fontan palliation has the approximate life expectancy of a 75-year-old with normal, but serious age-advanced, cardiac physiology. Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., have administrative offices in Deerfield, Illinois and Boca Raton, Florida. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly-listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contact: Dr. James Yeager, Deerfield, Illinois, USA, Tel: +1-847-2122679 Email: [email protected] Mr. S.I. Noh, Seoul, Korea, Tel: +82 2 560 8000 Email: [email protected] SOURCE Mezzion Pharma Co. Ltd.