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Restore Mind Medicine

Dr. Freeman Halts MM-110 Trial 2015 At IND meeting with FDA a safety directive was issued stating that MM-110 can only be administered at low doses (<20 mg) without additional pre-clinical (animal) safety data. June 15, 2020 (9:17 AM) Dr. Freeman halted the Phase I study at 8mg due to safety concerns-humans were more sensitive to MM-110 than indicated by previous pre-clinical studies. June 2020 Mr. Barrow was hired as a clinical development consultant and was appointed Chief Development Officer in January 2021. July 2020 MM-110 patient dosing continues at 12mg dose. 2015-2019 Savant lacks funding to perform pre-clinical or clinical studies. January - March 2021 The MM-110 protocol is amended to dose healthy volunteers at 1200 mg per day. Source: MindMed Press Releases, Company's SEC Filing, Clinicaltrials.gov. 2019 June 15, 2020 (12:00 PM) Dr. Freeman is suspended from his duties as CMO (he subsequently left the Company in August 2020): • Ms. Brigid Makes, a current board member, served as the Head of HR at the time. The current board should be aware of this as they performed an "independent" investigation, following FCM bringing this to the Board's attention - Dr. Freeman was never interviewed or asked for his account. • A contract research organization (who was performing the clinical trial) subsequently received a $300,000 cancellation fee for the halting of the dosing group. December 2021 MindMed is formed from Savant: • Dr. Freeman becomes CMO and initiates MM-110 healthy volunteer Phase I study. • Chief Scientific Officer, Dr. Don Gehlert, had responsibility for pre-clinical safety studies, NOT Dr. Freeman. MindMed completes Phase I MM-110 study with a dosing regimen of 650 mg per day (> 35x the dose the FDA believed was safe). May 2022 MindMed issues a press release touting the safety and tolerability of MM-110 in the Phase I study. August 2022 MindMed announces that it met with FDA to discuss moving to Phase II trial, but FDA reiterated the need for additional pre-clinical safety studies. MindMed shutters MM-110 program. 14
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