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Canadian Patent Grant Strengthens Small Pharma's International Position

Further Composition of Matter protection for SPL028, the Company’s next candidate expected to enter the clinic

LONDON, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, today announces that as of July 19, 2022 it has been granted patent no. 3104072 by the Canadian Intellectual Property Office.

This Canadian patent protects Composition of Matter of certain deuterated analogues of N, N-dimethyltryptamine (“DMT”), including the active ingredient in the Company’s deuterated DMT candidate, SPL028. It sits alongside the Company’s existing U.K. and European granted patents for SPL028, strengthening its protection in key international markets.

This new patent represents the ninth patent granted in Small Pharma’s psychedelic and non-psychedelic portfolio, which also includes over 70 pending applications. As recently announced, the Company expects its portfolio to further mature to ten granted patents following its Issue Notification from the United States Patent and Trademark Office that U.S. patent application no. 17/459,284 will be granted on August 9, 2022. This U.S. patent is expected to protect novel injectable formulations of DMT-based compounds, including the active ingredients in SPL026 and SPL028.

George Tziras, Chief Executive Officer of Small Pharma, said: “As we prepare to enter the clinic with SPL028, this additional protection bolsters our development strategy around one of our core pipeline compounds. We are pleased that the Canadian patent office recognizes our efforts to develop novel and differentiated medicines, which validates Small Pharma’s ability to mature our portfolio across multiple jurisdictions.”

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 a short psychedelic experience (<30 mins) and the potential for rapid-acting and long-lasting antidepressant effects. Deuterated DMT is potentially differentiated by its pharmacokinetic profile that aims to target a >30-minute short psychedelic experience, with the goal of optimizing patient convenience and expanding therapeutic potential in depressive disorders and additional indications.

For further information contact:

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

Kristi Papanikolaw
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
Tel: +1 (347) 487-6181

Media Relations Contacts:
USA - McKenna Miller
KCSA Strategic Communications
Email: smallpharmapr@kcsa.com
Tel: +1 (949) 949-6585

Rest of World - 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, and protection afforded by, patent application no. 17/459,284 on August 9, 2022 in the United States; and the Company’s ability to develop solutions and/or therapies to effectively address depression and/or other mental health conditions through DMT-based therapies.

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 U.K. Medicines and Healthcare products Regulatory Agency (“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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