Mr. Christopher Moreau reports

ALGERNON PHARMACEUTICALS RECEIVES JAPANESE PATENT NOTICE OF ALLOWANCE FOR TREATMENT OF NASH WITH REPIRINAST

Algernon Pharmaceuticals Inc. has received a notice of allowance from the Japanese Patent Office for patent application No. 2021-512244 entitled "Compositions and Methods for Treating Non-Alcoholic Steatohepatitis" with NP-251 (Repirinast).

The invention claims treating non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast. The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection. The company was recently issued a patent from the U.S. patent office for Repirinast in NASH and has also filed corresponding patent applications in Canada, Europe and China.

The company previously disclosed that Repirinast, in a widely used Stam mouse model of NASH from SMC Laboratories (Japan): reduced hepatic fibrosis by 57 per cent compared with vehicle (p less than 0.0001); reduced the NAFLD score, a composite histopathological measure of inflammation, steatosis and ballooning, by 31 per cent compared with vehicle (3.125 vs 4.5 points, p equals 0.059); in the same model, telmisartan, a positive control and the standard of care for NASH, reduced fibrosis by 27 per cent (p equals 0.014).

Repirinast is also the company's lead candidate for the treatment of CKD based on data showing it reduced fibrosis by 51 per cent with statistical significance and showed an additive benefit to telmisartan in a unilateral ureteral obstruction (UUO) mouse model. Because patients with NAFLD have a two-fold increased risk of CKD, even when controlling for other comorbidities such as obesity, Type 2 diabetes mellitus and insulin resistance, Repirinast is a strong candidate for both indications.

Algernon's intellectual property strategy for its repurposed drug program includes protecting its compounds by filing patent applications including method of use, dosing and formulations, and for new composition of matter patents based on novel salt forms.

"This is another major milestone for Algernon's innovative drug repurposing program and is further validation of our intellectual property strategy," said Christopher J. Moreau, chief executive officer of Algernon Pharmaceuticals.

About Algernon Pharmaceuticals Inc.

Algernon Pharmaceuticals is a Canadian clinical stage drug development and repurposing company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals has active research programs for IPF with chronic cough, and chronic kidney disease, and is the parent company of a newly created private subsidiary called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of psychedelic DMT for stroke and traumatic brain injury.

We seek Safe Harbor.