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Canadian biotech (formerly Nova Mentis Life Science, renamed November 2024) developing psilocybin therapy for Fragile X Syndrome and autism spectrum disorder. Lead candidate NM-1001 received Health Canada authorisation for a Phase IIA clinical trial, making it one of the few psilocybin programmes targeting neurodevelopmental conditions.

Development Programmes

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NM-1001 (Psilocybin Microdose)

Psilocybin
Phase IIPaused

Fragile X Syndrome / Autism Spectrum Disorder — enrollment stalled

Programme Tracker

Autism Spectrum Disorder (ASD)

Primary: Canada (HC)
Phase IIpaused

Trial stalled — enrollment has failed to meet targets since screening began April 2023. 10-patient open-label study at KGK Science, London, Ontario. Company pivoted to wellness food business (BrainBalls, Holy Crap Foods). Renamed from Nova Mentis to Restart Life Sciences November 2024.

Milestones

Phase II started

Completed

Actual: Apr 1, 2023

Participant screening began at KGK Science facility in London, Ontario

Why it matters: Screening initiation confirmed the trial was operational, but subsequent enrollment proved extremely difficult — Fragile X is a rare disorder (1 in 4,000-7,000) and psilocybin studies face recruitment barriers with neurodevelopmental populations.

Watch next: No enrollment completion or data readout has been announced. Trial appears stalled.

Regulatory review accepted

Completed

Actual: Dec 1, 2022

Health Canada No Objection Letter for NM-1001 Phase 2a — first psilocybin clinical trial approved for Fragile X Syndrome

Why it matters: Health Canada approval for psilocybin in Fragile X was a first-of-its-kind regulatory milestone. NM-1001 targets the mGluR5 pathway via psilocybin's effects on serotonin receptors — Fragile X involves overactivated mGluR5 signalling. Orphan drug designation in both US and EU.

Company milestone

Completed

Actual: Nov 1, 2024

Company renamed from Nova Mentis Life Science Corp. to Restart Life Sciences Corp. (CSE: HEAL)

Why it matters: Rebrand coincided with strategic pivot away from psilocybin clinical development toward wellness food brands. Suggests diminished commitment to the NM-1001 programme.

Company milestone

Completed

Actual: Feb 27, 2026

Closed acquisition of Holy Crap Foods ($1M, adds >$1M annualised revenue) — completing pivot to health food/wellness brands

Why it matters: The Holy Crap Foods acquisition, alongside BrainBalls and BrainQ cereal launches, confirms Restart has effectively pivoted from drug development to consumer wellness. The NM-1001 Fragile X trial remains technically active but appears abandoned in practice.

Recorded Events

Feb 27, 2026: Company milestone

Nov 1, 2024: Company milestone

Apr 1, 2023: Phase II started

Dec 1, 2022: Regulatory review accepted

Quick Facts

Type
Public Biotech
Ticker
CSE: HEAL
Lead Stage
Phase II
Website
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