Mind Medicine (MindMed) Inc. (NEO: MMED) (OTCQB: MMEDF) entered into an agreement with Canaccord Genuity Corp. to purchase, on a bought deal basis an aggregate of 11,364,000 units of the company at a price of C$4.40 per unit for gross proceeds of C$50 million. the company said the net proceeds will be used for investment in Project Lucy, Albert (the company’s digital medicine division), additional microdosing research and development, Project Layla (18-MC) as well as general working capital.
MindMed also announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of lysergic acid diethylamide (LSD) assisted therapy for anxiety disorder. This FDA meeting is an important milestone for the company and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the U.S. The psychedelic drug company also said it plans to open the IND with the FDA in August 2021, with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder.
MindMed Co-Founder & Co-CEO J.R. Rahn said “The FDA is one of the most impactful organizations for regulated drug development globally. We look forward to working through the FDA pathway on psychedelic-assisted therapies in strict compliance with their proven drug development guidelines and commencing our Phase 2b trial for Project Lucy in 2021.”
While Project Lucy focuses on LSD, Project Layla has been tagged as an addiction treatment program evaluating the ibogaine derivative 18-MC. The preliminary data from the Phase 1 Multiple Ascending Dose (MAD) and Single Ascending Dose (SAD) study has shown that the drug is safe and well-tolerated at the doses tested to date and that no serious side effects have been reported.
MindMed’s clinical team and 18-MC’s Medical Director, Dr. Judy Ashworth, have decided to continue dose escalation in the study to gather higher dosing data. The company has said that once that additional data has been reviewed, MindMed will directly thereafter initiate the Phase 2a proof of concept study. A meeting with the FDA has been confirmed to continue discussions regarding the 18-MC clinical development plan.
In addition to raising C$50 million, each unit shall consist of one subordinate voting share and one-half of one Subordinate Voting Share purchase warrant of the company. The statement said that each Warrant shall be exercisable to acquire one Subordinate Voting Share at an exercise price of C$5.75 per Subordinate Voting Share for a period of 3 years from the closing of the Offering, subject to a Warrant acceleration right exercisable by the company if the daily volume-weighted average trading price of the Company’s Subordinate Voting Shares on the NEO Exchange is greater than C$9.00 per Subordinate Voting Share for the preceding 5 consecutive trading days.