Optimi Health to supply MDMA for MAPS Israel PTSD trial

Mr. Dane Stevens reports OPTIMI HEALTH TO SUPPLY MDMA TO MAPS ISRAEL'S CLINICAL TRIAL FOR TRAUMA-RELATED PTSD Optimi Health Corp. has been selected to supply the MDMA capsules for MAPS Israel's Healing October 7 project, which includes a clinical trial for posttraumatic stress disorder (PTSD) that has received formal approval from the Israeli Ministry of Health. The open-label, multicentre, non-inferiority study will evaluate the safety and effectiveness of individual versus group MDMA-assisted therapy for PTSD in patients diagnosed in the context of recent collective trauma. The trial is being conducted as part of MAPS Israel's Healing October 7 initiative, which supports survivors, veterans and community-based care. The study will enroll 168 participants, with initial approval already granted by the Israeli Ministry of Health for the first 20 patients. Each participant will receive three MDMA-assisted therapy sessions supported by Optimi's GMP 40-milligram and 60 mg MDMA capsules, in accordance with the clinical protocol. Optimi has completed the first export of its GMP 40 mg and 60 mg MDMA capsules to Israel in support of this clinical program, which is sponsored by Sheba Medical Center and conducted across two clinical sites: Lev Hasharon Mental Health Centre and Be'er Sheva Mental Health Centre. Dr. Revital Amiaz, a key sponsor and head of psychiatry at Sheba Medical Center, stated: "MDMA-assisted therapy offers a meaningful clinical advantage in treating PTSD. Unlike traditional approaches that focus on exposure or symptom management, MDMA reduces fear and emotional reactivity, allowing patients to process traumatic memories more effectively and achieve more durable improvement. "In light of the rise in PTSD cases in Israel since Oct. 7, this study aims to evaluate a group-based MDMA-assisted therapy model that may enable clinicians to treat more patients simultaneously and expand access to care. The study will also increase the sample size, helping us better understand the effectiveness of this treatment approach. These developments mark an exciting step forward for trauma care and for Israeli psychiatry." "Two years ago, we embarked on a journey to bring a scalable solution for this massive PTSD wave, and since then have built this group therapy protocol, developed the needed clinical partnerships, and trained the necessary teams," added Eyal Gura, volunteering engineer-in-residence at MAPS Israel and co-founder of the Healing October 7 initiative. "We are happy to share this vision and collaborate with the Optimi team to bring this important group treatment protocol to the next proofing stage." "This collaboration is a meaningful step forward for Optimi's MMDA drug product," said Dane Stevens, chief executive officer of Optimi Health. "To be selected as the supplier for a trial of this importance is an honour. We remain focused on supporting partners like MAPS Israel with high-quality GMP medicines that meet the standards of modern clinical research." About the Healing October 7th clinical trial initiative Established immediately after Oct. 7 to prepare for substantial PTSD treatment needs, the initiative brings together leading medical centres and internationally recognized experts in PTSD and psychedelic-assisted therapies. Its purpose is to rigorously validate a cost-effective, scalable treatment model that, once proven, can reach large populations in need. About Optimi Health Corp. Optimi is a Canadian good manufacturing practices (GMP) compliant pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. From two 10,000-square-foot facilities in British Columbia and operating under a drug establishment licence from Health Canada, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program. We seek Safe Harbor.