Small Pharma Inc. (TSXV: DMT | OTCQB: DMTTF), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, today announces that it has received Issue Notification from the United States Patent and Trademark Office that its patent application no. 17/459,284 will be granted on August 9, 2022 in the United States under patent no. 11,406,619 for novel injectable formulations of N,N-dimethyltryptamine based compounds. The patent, which will represent the Company’s ninth issued patent, will be the first U.S. patent grant within the Company’s psychedelic portfolio, and includes formulations of DMT, the active ingredient in SPL026, and of deuterium-substituted DMT, including the active ingredient in SPL028. The patent will also protect novel injectable formulations of other known psychedelic compounds, including 5-methoxy-DMT and psilocybin.

Peter Rands, Chief Innovation and Intellectual Property Officer of Small Pharma, said: “Our focus is on developing novel and scalable mental health treatments for patients who are under-served by current medicines. This means diligent assessment of both clinical and commercial potential, and requires a strong patent approach to protect our formulations. We believe that this patent, covering our two most advanced DMT programs, SPL026 and SPL028, will provide protection of those assets until August 2041. We have focused on protecting our pipeline assets through novel chemistry and, in this case, optimized finished dosage forms.”

“This U.S. patent represents a major milestone in our development strategy. It is also timely, as we anticipate dosing completion in our SPL026 Phase IIa trial in patients with Major Depressive Disorder, and prepare for a Phase I study of SPL028 in healthy volunteers in the second half of this year. For Small Pharma’s longer-term vision, the U.S. will be an important market for DMT-assisted therapies as we look to shape the future of mental health treatments.”

George Tziras, Chief Executive Officer, Small Pharma

This patent will represent the ninth patent granted in Small Pharma’s psychedelic and non-psychedelic portfolio, which includes over 70 pending applications.

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a pipeline of proprietary preclinical assets.

About DMT

DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.