New United States patents will provide further support for the Company’s proprietary position in a key jurisdiction

United States grants will bring the Company’s total to 16 granted patents and over 90 applications pending C15H18O5

LONDON, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), 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.

George Tziras, Chief Executive Officer of Small Pharma, said: “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.”

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.

Small Pharma Inc. George Tziras, Chief Executive Officer Email: ir@smallpharma.co.uk Tel: +1 (646) 751-4363

Investor Relations Contacts: Eric Ribner LifeSci Advisors Email: eric@lifesciadvisors.com Tel: +1 (646) 889-1200

Media Relations Contacts: Jaber Mohamed MHP Communications Email: smallpharma@mhpc.com Tel: +44 (0)7720 326 847

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the granting of, and protections afforded by, patent application nos. 17/680,411 and 11 578 039 in the U.S.; the Company’s ability to develop a proprietary IP position in key markets, including the U.S. and Europe; and the Company’s ability to progress short-duration psychedelic assisted therapies for the treatment of mental health conditions.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The MHRA or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations.

The TSX Venture Exchange (“TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

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