Small Pharma Inc. (TSXV: DMT | OTCQB: DMTTF), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today announces an update to its intellectual property (“IP”) portfolio.

The Company has received a Notice of Allowance from the United States Patent and Trademark Office (the “USPTO”) for United States (“U.S.”) patent application no. 17/680,411. Once issued, the patent will provide composition of matter protection for a group of deuterated compounds of N,N-Dimethyltryptamine (“DMT”), as well as protection for therapeutic compositions and uses of the specified compounds.

Small Pharma has also received an Issue Notification from the USPTO that patent no. 11 578 039 will be issued on February 14, 2023. Once issued, the patent which will sit alongside the existing granted European patent no. 3 844 147, will provide Composition of Matter protection for certain deuterated homologues of certain tryptamine compounds, including the active ingredients currently being investigated in the SPL029 oral tryptamine series. The patent will also provide protection for therapeutic compositions of the deuterated tryptamines, including orally active formulations.

Following their issuance, the two new U.S. patents will bring the Company’s total number of granted patents in its psychedelic and non-psychedelic portfolio to 16, with over 90 pending applications. Small Pharma has developed a multi-layered patent strategy targeting key areas of protection across its research and development pipeline. The protection surrounding SPL026 includes an optimized injectable formulation for extended shelf life, and an efficient synthetic route that manufactures a Good Manufacturing Practice (GMP) compatible formula, which is scalable for commercial purposes. Further protection surrounding the Company’s pipeline candidate SPL028 and the SPL029 series includes Composition of Matter protection of its deuterated compounds, as well as medical use and therapeutic composition protection.

“Innovating on known compounds has always been the foundation of Small Pharma’s vision, and we continue to explore ways to innovate on our assets to optimize their clinical and commercial potential. Building a robust IP position is central to protecting these innovations and allows our pipeline programs to develop towards a proprietary position in key markets, including the U.S. and Europe. Combined with the recent positive data from our Phase IIa trial for SPL026 in Major Depressive Disorder, our portfolio continues to strengthen in support of our mission to bring novel, scalable and reimbursable short-duration treatments to mental health patients.”

George Tziras, Chief Executive Officer of Small Pharma.

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-duration psychedelic-assisted therapies for the treatment of mental health conditions. The Company’s current focus is on exploring new therapeutic approaches for depression. Small Pharma’s lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing clinical programs of SPL026 and SPL028 with supportive therapy for the treatment of mental health conditions, and was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) for intravenous SPL026 with supportive therapy for Major Depressive Disorder. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.