Apex Labs Files for US Patent Protecting Psychedelic Drug Delivery System

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Mar 07, 2024, 10:07 ET

-Patent pending uniquely formulated capsule improves stability and bioavailability for psilocybin and other psychedelics
-Supports both APEX-52 take home microdose and APEX-90 in-clinic macrodose psilocybin drug assets

VANCOUVER, BC, March 7, 2024 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin is pleased to announce the filing of a provisional patent application with the United States Patent and Trademark Office (USPTO). The patent application applies to APEX's uniquely formulated capsule which will be used for PATHFINDER-52 and SUMMIT-90 phase 2b clinical trials and in APEX's Early Access Program (EAP). The data shows that APEX's innovative approach improves bioavailability, oxidative stability and thermal stability for psilocybin and other psychedelics at both low and high doses.

"I am incredibly proud of the APEX research and development team for their years of hard work to develop our innovative drug delivery system," says Tyler Powell, CEO and co-Founder. "This patent application is a core pillar of our intellectual property strategy, paving the way for strong and sustainable commercial sales."

In Q1 2024 APEX received its Controlled Drugs and Substances Dealer's Licence (DL) which authorizes the organization to sell APEX drug through Health Canada's Special Access Program (SAP) providing access to treatment for Canadians outside of clinical trials.

"The team has worked diligently to hit this milestone in our drug development program with the unique capsule empowering dosing of APEX drugs in-clinic and at home," says Dr. Orion Lekos, Chief Science Officer and co-Founder. "We are confident the increased bioavailability and effectiveness of our drug assets will position APEX as a leader in the sector."

About Apex Labs Ltd.

APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care with psilocybin. By bringing data supported, clinically evaluated drugs to market for depression in PTSD, APEX's strategy is focused on developing pharmaceutical products by evaluating safety and efficacy across multiple indications alongside a robust Early Access Program.

APEX sees Veterans as a patient base with the most severe unmet need, supporting Veteran patients first and expanding to broader global patient communities.

Visit apexlabs.com for more information and follow APEX on LinkedIn, Twitter and Instagram.

Forward-Looking Statements

This release contains certain "forward-looking statements" and certain "forward-looking information" as defined under applicable Canadian securities laws. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "continue", "plans" or similar terminology. Forward-looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability to control or predict, that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: receiving of Health Canada Dealers Licence; filing US provisional patent, the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 (psilocybin) in treating depression in Veterans and patients with Post-Traumatic Stress Disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statements made by the Company's executives with respect to Health Canada's Dealer's Licence and capsule patent filing; the Company's efforts around the Early Access Program; statements made relating to Canadian Veteran patients; the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward-looking information except as required by applicable law. Such forward-looking information represents managements' best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information.

SOURCE Apex Labs Ltd.