November 30, 2020 Vancouver, British Columbia – Lobe Sciences Ltd. (“Lobe” or the “Company”) (CSE: LOBE) (OTC Pink: GTSIF) is pleased to announce the launch of preclinical research studies using psilocybin and N-Acetylcysteine (“NAC”) for the treatment of mild traumatic brain injury/concussion (“mTBI”) with
post-traumatic stress disorder (“PTSD”). The study is in collaboration with a multidisciplinary team of scientists and physicians at the University of Miami Miller School of Medicine under the lead of Michael E. Hoffer, M.D., professor of otolaryngology and neurological surgery.
The assets being sold to Ionic may include, but are not limited to, the assignment of all property leases relating exclusively to Cowlitz’s business, the assignment of Lobe’s option agreement to acquire all of the outstanding shares of Cowlitz, and the assignment of other contracts and rights related exclusively to Cowlitz including service contracts and equipment leases (the “Assets”).
The Miller School of Medicine is an internationally recognized leader in medical research, ranked No. 39 among the top medical schools in the nation by Blue Ridge Institute for Medical Research. In 2019, the medical school submitted 1,968 research proposals and was awarded $149 million in research funding from the National Institutes of Health (NIH).
The sale price for the Assets shall be a minimum of CAD$23 million, payable through the issuance of Ionic post-consolidation common shares (being approximately 49% of Ionic’s estimated $47 million capitalization post-restructuring (after giving effect to the Ionic Consolidation and Debt Conversion)), prior to giving effect to the Ionic Concurrent Financing. Following the closing of the Transaction, it is expected that the Lobe will own approximately 49% of Ionic’s common shares, on a post-consolidation and pre-Ionic Concurrent Financing basis. Ionic is expected to have a minimum total capitalization valuation of CAD$47 million, preIonic Concurrent Financing.
As previously announced, Lobe has been pursuing strategic alternatives for Cowlitz, aimed at maximizing its value to the Company. Cowlitz reported over US$14.6 million in gross sales revenues for the nine month period ended September 30, 2020, according to data provided on reports to the Washington State Department of Revenues(1). Lobe generates revenues through licensing and leasing agreements in place with Cowlitz.
Maghsoud Dariani, Chief Science Officer of Lobe said, “We are very excited to begin the preclinical studies in collaboration with Dr. Hoffer and his team at the University of Miami. They have made significant in-roads studying psychedelic medicine specifically as it relates to mTBI and PTSD. NAC has been shown as the only compound that has adequate pre-clinical studies to validate use and, to date, remains the only compound that has successfully completed a phase 1 equivalent trial in a population of individuals who had acute mTBI.
Given there are currently no proven effective medical treatments for the treatment of mTBI and PTSD, we feel this is an important study that can lead to human clinical trials and eventually therapeutics to make a positive impact in the physical and mental wellbeing of millions of people.”
About Lobe Sciences Ltd.
Lobe is a growth-oriented research, technology & services company that provides financial, management, IP and branding support to businesses. The Company operates a portfolio of companies focused on developing transformational medicines and applies refined strategies to help partner companies reach their full potential.
Based in Vancouver, BC, Lobe Sciences creates value through acquisitions and development of assets, products and technologies by leveraging its scientific, engineering, branding and operational expertise supported by strong capital markets acumen.NAC has been shown to be safe and efficacious in a phase I human clinical study in
treating military personnel who had suffered mTBI. The initial research focus is to demonstrate the safety and efficacy of the combination of psilocybin and NAC using broadly accepted rodent models. Final results are expected in 2021. Once this is established, more specific work can examine dose response, medicine uptake, and medicine levels. The research team at the Miller School of Medicine has conducted prior studies involving NAC with mTBI and has a license from the United States Drug Enforcement Administration to conduct research using Schedule I controlled substances, which includes psilocybin.Advances in neuro-diagnostic assessment have revealed mild traumatic brain injury (concussion) is more common than previously thought and potentially associated with a host of negative health outcomes. The Centers for Disease Control (“CDC”) estimates that there are 3 million emergency room visits and over 230,000 hospitalizations due to TBI in any given year in the United States alone. Also, at the same time there are 5.3 million Americans living with the effects of mTBI (a 53% increase over ten years ago). The World Health Organization calls traumatic brain injury a “silent epidemic” that affects over 70 million individuals across the world. The United States Department of Defense estimates that over 345,000 individuals are affected by mTBI and that 20% of all service members who deploy suffer mTBI. mTBI and PTSD are significant health care issues that often co-occur and impact each other.Dr. Hoffer, the principal investigator on the study, said, “This a very important extension of our work with NAC and other medicines to identify new treatments for mTBI and PTSD. We are hopeful that this new combination of psilocybin with NAC will lead us to better solutions for those suffering from mTBI and/or PTSD.”
11/30/2020 2:00:00 PM