Mr. Christopher Moreau reports

ALGERNON PHARMACEUTICALS ANNOUNCES GRANT OF U.S. PATENT FOR REPIRINAST IN NAFLD AND NASH

Algernon Pharmaceuticals Inc. has been issued a patent from the United States Patent and Trademark Office (USPTO), No. 11744808, for its lead chronic kidney disease (CKD) program drug NP-251 (repirinast), entitled "Compositions and Methods for Treating Non-Alcoholic Steatohepatitis."

The invention claims treating non-alcohol 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 2039, excluding any patent term adjustments or extensions, which may provide additional protection. The company has also filed corresponding patent applications in Canada, Europe, China and Japan.

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 versus 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 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 the first patent received from the USPTO by Algernon for one of its drugs being investigated under its innovative drug repurposing program and is further validation of our intellectual property strategy," said Christopher J. Moreau, chief executive officer of Algernon Pharmaceuticals. "The company's global intellectual property suite now includes three granted patents in additional to 21 patents pending."

About NP-251 (repirinast)

Repirinast was originally developed by Mitsubishi Tanabe Pharma, and was sold and marketed in Japan under the brand name Romet for the treatment of asthma. Romet was marketed for over 25 years in Japan. Mitsubishi discontinued manufacturing and sales of the drug in 2013. Accordingly, Algernon has retained Zhejiang Ausun Pharmaceutical in Zhejiang, China, to manufacture a cGMP (current good manufacturing practice) repirinast supply.

Mast cells are recruited to sites of cellular damage, and degranulation of mast cells leads to release of a myriad of pro-inflammatory chemical mediators, which lead to tissue damage in a self-propagating cascade. NP-251 binds to receptors on mast cells and prevents their degranulation, which the company believes could help prevent fibrosis in multiple organ classes, including the kidneys.

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 chronic cough and chronic kidney disease and is the parent company of a private subsidiary called Algernon NeuroScience that is advancing a psychedelic program investigating a proprietary form of psychedelic DMT (N,N-dimethyltryptamine) for stroke and traumatic brain injury.

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