Corneal Edema

SEATTLE & CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that CEO Greg Kunst has won one of the Healthcare Leadership awards from the Puget Sound Business Journal (PSBJ). Each year, PSBJ celebrates outstanding leaders in health care around the Puget Sound area. The Healthcare Leadership awards highlight innovative and influential thinkers whose leadership has had a lasting impact. “This prestigious recognition from Puget Sound Business Journal really belongs to my incredibly talented team here at Aurion Biotech,” said Greg Kunst, CEO. “We are honored to receive this award, as it increases awareness of our transformational work, and our collaborative efforts to bring our cell therapy to millions of patients around the world who suffer from corneal endothelial diseases.” Aurion Biotech is a clinical stage company developing a novel cell therapy to treat patients with corneal endothelial disease, which affects more than 16 million people throughout the world. This off-the-shelf, ready-to-use cell therapy does not require immune matching. Aurion Biotech has acquired the intellectual property rights covering the pioneering inventions of Professor Shigeru Kinoshita, MD, Ph.D. of Kyoto Prefecture University of Medicine: cell therapy for treating corneal endothelial disease. Earlier this year, the company received regulatory approval in Japan. To date, 130 subjects have been treated in multiple completed studies involving multiple surgeons and diverse patient populations. Subjects have experienced consistent, clinically meaningful and sustained improvements in key measures of corneal health. The company launched its multi-center U.S. Phase 1/2 trial (NCT06041256) this year. About Aurion Biotech With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company’s first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and is the first off-the-shelf, clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. in 2023. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit View source version on businesswire.com: Contacts Judith McGarry (corporate communications) 415-971-2900 judith.mcgarry@aurionbiotech.com Michele Gray (ophthalmology media) 917-449-9250 michele@mgraycommunications.com Beth Keshishian (biotech & business media) 917-912-7195 beth@bethkeshishian.com Source: Aurion Biotech View this news release online at:

Annual Awards Program Recognizes Innovation in the Global Life Sciences and Biotechnology Industry SEATTLE & CAMBRIDGE & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced it has been selected as “Regenerative Therapeutics Company of the Year” in the third annual BioTech Breakthrough Awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe. Aurion Biotech is a clinical stage company that is developing a novel cell therapy to treat patients with corneal endothelial disease, which affects more than 16 million people throughout the world. Its cell therapy procedure is accessible for ophthalmologists, involving a single administration into the anterior chamber of the patient’s eye. The company’s proprietary manufacturing process enables it to reproduce fully differentiated corneal endothelial cells in vitro. Healthy cells from a single donor can be used to manufacture cells for more than 100 treatments. Additionally, this off-the-shelf, ready-to-use cell therapy does not require immune matching. Leveraging the pioneering inventions of Professor Shigeru Kinoshita, MD, of Kyoto Prefecture University of Medicine, Aurion Biotech has acquired the technology for further development. Earlier this year, the company received regulatory approval in Japan. In completed trials to date, 130 subjects have been treated in multiple studies involving multiple surgeons and diverse patient populations. Subjects have experienced consistent, clinically meaningful and sustained improvements in key measures of corneal health. The company launched its U.S. Phase 1/2 trial (NCT06041256) this year. “We are honored to be named BioTech Breakthrough’s ‘Regenerative Therapeutics Company of the Year,’” said Greg Kunst, Aurion Biotech’s CEO. “Receiving this recognition is another step in our effort to help millions of patients in need around the world.” The mission of the annual BioTech Breakthrough Awards program is to conduct the industry’s most comprehensive analysis and evaluation of the top companies, solutions and products in the life sciences and biotechnology industry today. This year’s program attracted more than 1,500 nominations from over 12 different countries throughout the world. “Aurion Biotech’s cell therapy has the potential to help restore vision to millions of underserved patients around the world suffering from corneal endothelial disease, a serious, sight-threatening and debilitating condition,” said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards. “The current standard of care, corneal transplantation, is a complex surgical procedure which is difficult to perform and, currently, there's a severe worldwide shortage of donor corneas. Aurion Biotech is advancing a game-changing single-dose cell therapy for this condition.” About Aurion Biotech With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company’s first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and is the first off-the-shelf, clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. in 2023. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit About BioTech Breakthrough Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Food Science and BioAgriculture, and more. For more information visit BioTechBreakthroughawards.com Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose. View source version on businesswire.com: Contacts Judith McGarry (corporate communications) 415-971-2900 judith.mcgarry@aurionbiotech.com Michele Gray (ophthalmology media) 917-449-9250 michele@mgraycommunications.com Beth Keshishian (biotech & business media) 917-912-7195 beth@bethkeshishian.com Source: Aurion Biotech View this news release online at:

Allogeneic Cell Therapy for the Treatment of Corneal Edema Secondary to Corneal Endothelial Dysfunction SEATTLE & CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that it has dosed the first subject in its Phase 1 / 2 U.S. clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction. “On the heels of our recent approval in Japan, we are very pleased to have begun dosing subjects in this trial in the United States,” said Michael Goldstein, MD, MBA, President and Chief Medical Officer of Aurion Biotech. “The start of this trial is another important milestone in our goal of bringing this corneal endothelial cell therapy to millions of patients in need throughout the world. We believe that cell therapy has the potential to revolutionize the treatment of corneal patients around the world.” AURN001 is a combination cell therapy product (biologic/drug) comprised of neltependocel (allogeneic human corneal endothelial cells (CECs]) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase [ROCK]). AURN001 is intended to be administered to the eye as a one-time, intracameral injection. The Phase 1 / 2 clinical trial (ABA-1, CLARA) is a prospective, multi-center, randomized, double masked, parallel-arm cell dose-ranging clinical trial in subjects with corneal edema secondary to corneal endothelial dysfunction. The study will evaluate three different doses of neltependocel used in combination with Y-27632. Approximately 100 subjects will be randomized at US sites. This trial is designed to assess the safety, tolerability, and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. The primary endpoint is percentage of subjects who gain 3 lines of vision at 6 months. About Corneal Endothelial Dysfunction Corneal edema secondary to endothelial dysfunction is a sight-threatening and debilitating condition affecting millions of people throughout the world. When corneal endothelial cells die or degrade, they do not regenerate. If left untreated, corneal endothelial cell loss can cause corneal edema (swelling) and loss of vision. Although corneal transplants are effective, there are disadvantages with these procedures – PKP/DMEK/DSAEK – including limited donor organ supply. Transplants require a supply of donor corneas in a 1:1 ratio (one healthy donor cornea to treat each diseased one), yet it’s estimated that there is only one donor cornea available for every 70 diseased eyes.1 In addition, post-operative recovery for corneal transplant patients requires that they like flat on their backs for up to three days, in order for the transplant to adhere to the corneal stroma. About Aurion Biotech With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company’s first candidate is for the treatment of corneal edema secondary to corneal endothelial dysfunction, and is the first off-the-shelf, clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, please visit . _____________________________ 1