Revive Therapeutics Ltd. to provide an update on the Company’s clinical development plan for Autoimmune liver diseases, which includes Cannabidiol in the treatment of Autoimmune Hepatitis. Revive aims to build a portfolio of cannabinoid-based drugs for the treatment of rare inflammatory diseases with its initial focus on Autoimmune liver diseases (AILD). AILD are relatively rare diseases that are comprised of namely four indications including Autoimmune hepatitis (AIH), primary biliary cirrhosis, primary sclerosing cholangitis, and immunoglobulin G4 related cholangitis. These are chronic diseases that result in significant morbidity and mortality. Revive will focus on the clinical development of Cannabidiol (CBD) in the treatment of AIH with plans to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in 1H 2020 for a proposed Phase 1/2a clinical study to determine the recommended dose of CBD for future clinical studies, to assess its safety, efficacy and clinical benefit, as well as to support a New Drug Application (“NDA”). The Company aims to have a pre-IND meeting with the FDA to obtain feedback of Revive’s intended clinical development plan, including a proposed Phase 1/2a study design. Revive’s program is to meet a clear unmet medical need in patients with AIH. AIH is a rare inflammatory condition of the liver that can affect all ages and gender across the world. If not treated properly, may cause liver fibrosis or cirrhosis, liver failure requiring a liver transplant, and even death. The prevalence of AIH is estimated at 75,000 patients in the U.S. The current standard of care for AIH is the use of steroids alone or steroids combined with azathioprine. It has been noted in medical literature that the current standard of care when used in a certain period of time has caused severe treatment-related side effects in 13%, treatment failure in 9%, incomplete response in 13%, and relapse after drug withdrawal up to 86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb. 28; 16(8): 934–947). Therefore, given the unwanted outcomes associated with a steroid-based therapy, an alternative steroid-free treatment option such as CBD, with its known safety profile, may provide a potential solution for an improved treatment strategy for those patients unresponsive to, intolerant of, or non-adherent with a steroid-based therapy for AIH. Revive has an exclusive license from South Carolina Research Foundation for its intellectual property for the use of CBD, either in synthetic or natural form, in the treatment of autoimmune hepatitis (U.S. patent No. 8242178). Also, the FDA has granted to Revive orphan drug designation for CBD in the treatment of AIH, which provides valuable incentives that could accelerate the approval process, including seven-year market exclusivity, tax credits on U.S. clinical trials, fast-tracking of regulatory proceedings, and exemption from certain fees, such as waiver of filing fees under the Prescription Drug User Fee Act (PDUFA), and orphan drug grants. Additionally, the Company will now not be proceeding with the subscription receipt private placement offering announced on November 12, 2019.