Ann: Regeneus and Kyocera sign Progenza OA deal, page-2

WOW..... HUGE !!

Regeneus and Kyocera sign Progenza OA licence and collaborationagreement
Highlights:•Regeneusand Kyocera havesigned alicence and collaborationagreement for Kyocera to exclusively develop and commercialise Regeneus’ lead stem cell platform technology Progenza for the treatment of Knee Osteoarthritis (Knee OA) in Japan•Regeneus to receiveUS$19m(A$27m)in upfront, development and regulatory milestone payments•Additional single to high double-digit royalties on Progenza OA product sales in Japan based on future reimbursement prices•Kyocera will fund manufacturing, development, and commercialisation costs for Progenza OA in Japan under the agreement •Upfront payment provides cash runway for Regeneus through to thecommercial launch of ProgenzaOA in Japan•The global market for osteoarthritis is expected to grow to US$3.5 billion by 2026 with the Japanese market worthUS$350 million1. The potential osteoarthritis patient population is 25.6 million in Japan with 1.25 million people receiving treatment, and is expected to rise each year2.Regeneus Ltd (ASX: RGS)(Regeneusor the Company), a clinical-stage regenerative medicine company,today announced that KyoceraCorporation (Kyocera, TYO:6971) has signed a licence agreement to develop and commercialise Progenza for Knee Osteoarthritis (Progenza OA) in Japan. ProgenzaOAhas already completedaPhase I study which met all safety and efficacy endpoints. The study demonstrated that a single injectionof ProgenzaOAinto the knee was safe, tolerable and showed significant, rapid and sustained reductions in knee pain for osteoarthritis patients,andshowed positive signs of disease modification showing no deterioration in the joint following the injection. The licence and collaborationagreement follows the two companies signing a Memorandum of Understanding (MOU) in March 2020, and Kyocera completing detailed due diligence on ProgenzaOA.