Apex Labs Granted Israel MoH Approval to Expand Phase 2b Macrodose Psilocybin PTSD Clinical Trial

• Israel’s Ministry of Health (MoH) approval to add additional sites to APEX SUMMIT-90 160 patient phase 2b macrodose clinical trial:
  
  
  • Tel Aviv University (TAU)’s Institute for Psychedelic Research located at the Sagol Brain Institute (SGI) in Tel-Aviv Sourasky Medical Center.
  • Be'er Yaakov Mental Hospital (Merhavim) Center for Psychedelic Studies.
    
    
• For more information or to register visit clinicaltrials.gov (Canada) and mytrials.gov (Israel).

VANCOUVER, British Columbia, June 12, 2025 (GLOBE NEWSWIRE) -- Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin is pleased to announce the approval by the Israeli MoH and IRBs to open two additional clinical trial sites for SUMMIT-90. The trial is a double-blind, placebo controlled phase 2b study evaluating multiple doses of APEX-90, a psilocybin macrodose utilizing APEX’s US patent pending capsule. APEX-90 is administered in-clinic with study-assisted psychotherapy for severe depression within diagnosed PTSD. Israel is facing a severe mental health crisis: 44% of adults report depression and 42% PTSD, far above the 8–13% depression and 6–10% PTSD rates seen in the US and Canada.

/EIN News/ -- This MoH approval leverages the expertise of TAU’s renowned SGI and Merhavim Hospital, which both have a rich history of pioneering research in neurological sciences. Their cutting-edge facilities and teams profound understanding of PTSD dynamics are poised to add patient recruitment expertise.

“I am honoured to have been able to facilitate this new partnership; another example of building important bridges between Canada and Israel in innovative clinical research, which will result in advancing patient access to emerging treatments,” says Sharon J. Fraenkel, TAU Canada’s CEO for Ottawa, Quebec, and Atlantic Canada, on behalf of the organization.

“As someone deeply connected to Israel, witnessing the toll of PTSD among my loved ones, I'm driven to lead research that brings hope and healing,” says Alysa Langburt, APEX’s VP of Global Clinical Development. “This marks more than a clinical milestone, it represents a fundamental step towards transforming the mental health landscape in Canada and Israel, where the need has never been greater. Through our incredible partnerships, we aim to catalyze a shift in access, care and outcomes for those suffering with PTSD.”

"SUMMIT-90 offers a beacon of hope for the significant numbers suffering from PTSD in Canada and Israel,” says Tyler Powell, co-Founder and CEO of APEX. “It underscores our commitment to global mental health innovation and our belief in the opportunity for clinically proven psilocybin therapies to transform mental health care.”

About Apex Labs Ltd.
APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care with psilocybin. APEX's strategy is two-pronged, clinical evaluation of drug assets alongside a robust Early Access Program. APEX recognizes and prioritizes Veterans as a patient base with the most severe unmet medical need.

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 authorization 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; approvals by the Israeli Ministry of Health and ethics; 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.

For further information: info@apexlabs.com