U.S. Patent Grant to Strengthen Small Pharma’s DMT Patent Strategy With Injectable Formulation

Rhea-AI Summary

Small Pharma Inc. has received a patent issuance notification from the U.S. Patent and Trademark Office for its injectable DMT formulations under patent no. 11,406,619. This patent, effective August 9, 2022, will protect their two lead products, SPL026 and SPL028, until August 2041. The company’s CEO highlighted this as a pivotal moment in their strategy, coinciding with ongoing clinical trials for these therapies aimed at treating Major Depressive Disorder. Small Pharma’s portfolio now includes nine granted patents and over 70 pending applications.

Positive

• U.S. patent granted for injectable DMT formulations, protecting SPL026 and SPL028 until August 2041.
• The patent represents a significant milestone in the company's development strategy.
• Small Pharma's intellectual property portfolio now includes nine patents and over 70 pending applications.

Negative

• None.

Key U.S. patent protection on injectable delivery of DMT in lead programs SPL026 and SPL028

LONDON, July 26, 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 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 (“DMT”) 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.”

George Tziras, Chief Executive Officer, added: “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.”

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.

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 of patent application no. 17/459,284 on August 9, 2022 in the United States; the anticipated timeline for dosing completion in the SPL026 Phase IIa; the timeline for the anticipated launch of additional clinical trials; and the Company’s ability to develop solutions to effectively address depression 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.

FAQ

What is the significance of the U.S. patent for DMT formulations by Small Pharma?

The U.S. patent protects Small Pharma's injectable DMT formulations, SPL026 and SPL028, until 2041, establishing a crucial barrier for competitors.

When will the patent for DMT formulations be effective?

The patent will take effect on August 9, 2022.

What are SPL026 and SPL028?

SPL026 and SPL028 are Small Pharma's lead products based on DMT, aimed at treating Major Depressive Disorder and other conditions.

How many patents has Small Pharma been granted?

The company has been granted nine patents, including the recent one for DMT formulations.

What is the market potential for DMT-assisted therapies?

DMT-assisted therapies are anticipated to play a significant role in the future of mental health treatments, especially in the U.S.