Small Pharma Announces Significant Developments In Intellectual Property Portfolio

May 25, 2023 at 07:50 AM EDT

LONDON, May 25, 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, demonstrating significant progress already made by the Company in 2023.

Small Pharma aims to protect its pipeline programs through a multi-layered IP strategy with four core areas of protection. These areas of protection include: Composition of Matter, covering novel drug substances; Medical Use, covering therapeutic compositions and medical uses thereof; Drug Product, covering pharmaceutical formulations; and Synthetic Route, covering the novel and efficient synthesis of high purity drug substance at scale.

Since the previous IP portfolio update on February 1, 2023, the Company has secured five new granted patents, with three more expected to be granted by May 31, 2023. Additionally, it has received five patent Notices of Allowance. The additional IP covers the four focused areas of protection and multiple markets, strengthening the Company’s international IP position.

The new patent grants and Notices of Allowance are summarized below.

Patent Protection	Description	Market	Patent No.	Status
Composition of Matter	For certain deuterated homologues of certain tryptamine compounds	USA	11,578,039	Granted
	For certain deuterated homologues of certain tryptamine compounds	New Zealand	788543	Granted
	For certain deuterated analogues of N,N, dimethyltryptamine (“DMT”)	GB	2 592 822	Grant expected after May 22, 2023
	For a group of deuterated homologues of DMT	USA	11,660,289	Grant expected on May 30, 2023
	For a group of deuterated homologues of DMT	Europe	4 031 529	Notice of Allowance
*Medical Use*	Of certain deuterated analogues of DMT	GB	2 586 940	Grant expected after May 25, 2023
	Medical use and therapeutic compositions of a group of deuterated homologues of DMT	Australia	2021204158	Notice of Allowance
	Medical use and therapeutic compositions of a group of deuterated homologues of DMT	New Zealand	794833	Notice of Allowance
	Therapeutic compositions of a group of deuterated homologues of DMT	Japan	2022-574099	Notice of Allowance
*Drug Product*	Novel optimized injectable formulation of DMT based compounds	Australia	2021334933	Granted
*Drug Product*	Therapeutic solid dosage forms of deuterated DMT analogues	GB	2 595 776	Granted
*Synthetic Route*	Novel efficient synthesis of high purity DMT and deuterated DMT analogues at scale	USA	11,643,390	Granted
*Synthetic Route*	Novel efficient synthesis of high purity DMT and deuterated DMT analogues at scale	Canada	3160337	Notice of Allowance

As of May 24, 2023, Small Pharma’s IP portfolio consists of 19 granted patents, with 97 allowed or pending. The protection covering each of the Company’s pipeline programs is outlined below.

Candidate / Project	Relevant Patents in Portfolio (No. active patents / pending patent applications)
*SPL026¹, SPL028², SPL029*³	4 granted patents and 31 allowed and pending applications
*SPL028*	6 granted patents, 37 allowed and pending applications
*SPL028, SPL029*	8 allowed and pending applications
*SPL029*	4 granted patents, 11 allowed and pending applications
*Non-psychedelic / other*	5 granted patents, 10 allowed and pending applications

¹Intravenous or intramuscular DMT
²Injectable deuterated DMT series
³Oral tryptamine series

George Tziras, Chief Executive Officer of Small Pharma said: “Our team has made great progress this year to further strengthen our proprietary IP position in key international markets. We continue to build multi-layered IP protection around each of our pipeline programs, helping to optimize their commercial potential. We are pleased that our efforts to invest in developing novel treatment innovations for patients continues to be recognized in multiple jurisdictions.”

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 N, N-dimethyltryptamine. 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 IV SPL026 with supportive therapy for Major Depressive Disorder. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.

Contact Information:

Small Pharma Inc. & Investor Relations:
George Tziras, Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)7720 326 847

Media Relations:
Jenny Maguire, Head of External Affairs
Email: jenny.maguire@smallpharma.co.uk

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, three patents expected to be granted by May 31, 2023 and five patent Notices of Allowance across various jurisdictions, including Great Britain, the United States, Europe, Australia, New Zealand, Japan, and Canada; the Company’s ability to develop a proprietary IP position in key international markets; 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.