Entheon Biomedical Announces DMT Drug Supply Agreement with Psygen Labs Inc. Completion of Initial DMT Research Drug Batch and Exercise of Warrants
Newsfile Corp.
December 9, 2020, 6:30 am
Vancouver, British Columbia--(Newsfile Corp. - December 9, 2020) - Entheon Biomedical Corp. (CSE: ENBI) (FSE: 1XU1) ("Entheon" or the "Company"), a biotechnology company focused on developing psychedelic medicines to treat addiction, announced it has entered into a drug-supply agreement (the "Agreement") with Psygen Labs Inc. ("Psygen"). Under the terms of the Agreement, Psygen will supply Entheon with non-GMP and GMP (good manufacturing practice) quality N,N-dimethyltryptamine drug substances ("DMT") for upcoming formulation, preclinical, clinical, and post-approval commercialization phases under the European Medicines Agency (EMA) regulatory framework.
On November 27, 2020, Psygen successfully completed the production of a non-GMP DMT research batch for delivery to the Company's Contract Research Organization, CHDR's partner pharmacy. The non-GMP DMT research batch will be shipped to CHDR upon receipt of Psygen's export permit from the Health Canada Office of Controlled Substances. This export permit will be applied for following the successful receipt of CHDR's import permit, which has been applied for, and the granting of which is anticipated by the end of December.
The Agreement entered into on August 21, 2020 provides Entheon with access to a consistent DMT drug material for preliminary formulation, stability and testing required prior to its forthcoming human clinical trial, scheduled to begin in Q4 2021 at The Centre for Human Drug Research (CHDR) in the Netherlands.
"We are excited that Psygen has completed its initial research batch of non-GMP DMT. The completion of this batch represents the crucial chemical validation and formulation steps that are a regulatory requirement prior to human administration," said Chief Executive Officer of Entheon, Timothy Ko. "Partnering with Canada's first licensed manufacturer of restricted psychedelic drug products fosters an ecosystem of collaboration and innovation within the Canadian psychedelic space, and we are thrilled by the progress being made."
"We are excited to partner with Entheon Biomedical to supply DMT drug substance for its clinical research. We believe these studies will significantly improve outcomes for people who are suffering from substance use disorders," said Danny Motyka, CEO of Psygen.
Exercise of Warrants
Further, the Company is pleased to announce its shareholders have exercised an aggregate 533,359 warrants at a price of $0.75 per share and 13,334 warrants at $0.45 per share adding net proceeds of $406,019.55 to the Company's treasury. The warrants were issued by way of private placement with an expiry date of December 4, 2020. As of the expiry date, 82% of the warrants had been exercised. The use of proceeds will be employed to accelerate the Company's clinical and regulatory pathway. As of the date hereof, the Company has a total of 10,777,290 warrants that remain outstanding.
