Mr. Fabio Chianelli reports

PHARMATHER'S SAIRIYO THERAPEUTICS COMPLETES CLINICAL AND REGULATORY PACKAGE FOR PHASE 1 STUDY OF PATENTED REFORMULATED CEPHARANTHINE

Sairiyo Therapeutics Inc., a company that is 49 per cent owned by Pharmather Holdings Ltd. and 51 per cent owned by Pharmadrug Inc., has completed its clinical and regulatory package to evaluate Sairiyo's patented reformulated enteric coated version of orally bioavailable cepharanthine (PD-001) as a potential treatment for infectious diseases and oncology in a phase 1 clinical study in Australia.

Sairiyo's wholly owned subsidiary in Australia, Sairiyo Therapeutics Australia Pty. Ltd., will work with an Australian clinical research unit to submit the clinical and regulatory package to the Australian human research ethics committee for approval to conduct the human clinical study.

In pursuit of its clinical strategy for PD-001, Sairiyo aims to conduct its first-in-human clinical study of PD-001 in Australia to capitalize on drug development incentives in Australia, which could earn a 43.5-per-cent rebate from the Australian federal government's research and development tax incentive program. Upon completion of the clinical study, Sairiyo intends to submit an investigational new drug application for PD-001 to the U.S. Food and Drug Administration (FDA) to commence clinical trials in the United States.

About PD-001 (enteric-coated oral cepharanthine)

Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, cepharanthine has been shown to exhibit multiple pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects. However, historically cepharanthine's low oral bioavailability has represented a major obstacle to realizing its full clinical potential.

Compared with generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly improved oral bioavailability (more easily absorbed). These findings support the development of an orally administered formulation and, in so doing, remove the undesirable requirement for frequent intravenous dosing to maintain therapeutic levels of drug in circulation. Sairiyo endeavours to develop an efficacious oral therapeutic to potentially improve outcomes for infectious disease and oncology applications.

PD-001 is protected by U.S. patent US10576077, with a patent expiration date of March 23, 2036.

About Sairiyo Therapeutics Inc.

Sairiyo Therapeutics, which is owned by Pharmadrug (51 per cent) and Pharmather (49 per cent), is focused on advancing the clinical development of an improved and patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) to treat responsive cancers and infectious disease, including COVID-19.

About Pharmather Holdings Ltd.

Pharmather Holdings is focused on the development and commercialization of Ketarx (ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health and neurological indications. Pharmather owns 49 per cent of Sairiyo Therapeutics, which focuses on advancing the clinical development of an improved and patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) to treat responsive cancers and infectious diseases, including COVID-19.

We seek Safe Harbor.