Empyrean Neuroscience
Empyrean Neuroscience is a New York-based biotech pioneering the use of genetic engineering of fungi and plants to develop novel neuroactive therapeutics for CNS disorders. Founded in 2019, the company launched with a $22M Series A from Spore Partners and uses CRISPR/Cas9 technology licensed from ERS Genomics to genetically modify Psilocybe cubensis, Tabernanthe iboga, and Cannabis sativa. Lead programmes include an encapsulated psilocybin mushroom drug product (IND-enabling studies) and DMT-based therapeutics for MDD, PTSD, and substance use disorders.
Development Programmes
2PsiM+ / PsiB+ (Genetically Engineered Psilocybin Mushroom)
Genetically engineered encapsulated whole Psilocybe cubensis mushroom for major depressive disorder. Uses proprietary CRISPR/Cas9 platform (licensed from ERS Genomics) to modify psilocybin biosynthesis pathway genes (PsiD, PsiH, PsiK, PsiM). Aims to capture "entourage effect" from multiple co-occurring alkaloids — differentiated from synthetic/isolated psilocybin (COMPASS, Usona). FDA pre-IND meeting (late 2022) secured agreement to skip Phase 1 and proceed directly to pivotal-eligible Phase 2. HOWEVER: CEO and CMO both departed by Feb 2023; no IND ever filed; no clinical trial registered; pipeline page returns 404. Company appears dormant.
Programme Tracker
Major Depressive Disorder (MDD)
STALLED. FDA agreed to pivotal-eligible Phase 2 design (skip Phase 1) at pre-IND meeting late 2022. Phase 2 initiation was planned for 2023 but never materialized. CEO Usman Azam and CMO Fred Grossman both departed by Feb 2023 (~4 months after launch). No successor leadership announced. No IND filed. No clinical trial registered. No public activity since early 2023.
Milestones
Funding milestone
CompletedActual: Nov 18, 2022
$22M Series A closed, led by Spore Partners. Company publicly launches with CRISPR-engineered psilocybin mushroom platform. SAB announced: William Potter (NIMH), Husseini Manji (J&J, oversaw Spravato development), Francis Lee (Weill Cornell Chair of Psychiatry).
Why it matters: $22M is significant seed/Series A for a psychedelic company. SAB includes three of the most prominent names in CNS drug development. The genetic engineering approach (whole engineered mushroom) was genuinely novel in the psychedelic space.
regulatory-milestone
CompletedActual: Dec 1, 2022
FDA pre-IND meeting completed. FDA agreed to let Empyrean bypass Phase 1 in healthy volunteers and proceed directly to controlled, multi-arm Phase 2 study that could serve as pivotal trial for Phase 3. IND-enabling studies reportedly underway.
Why it matters: Extremely favourable FDA pathway — skipping Phase 1 saves 1-2 years and significant cost. Suggests FDA viewed the whole-mushroom formulation as sufficiently characterized from existing psilocybin safety data. However, this regulatory win was never acted upon after leadership departed.
Company milestone
CompletedActual: Feb 1, 2023
CEO Usman Azam (ex-Novartis, Tmunity) and CMO Fred Grossman (ex-Mesoblast, Eli Lilly) both depart Empyrean, approximately 4 months after launch. No successor leadership announced. Azam later becomes CEO of Inspirna (May 2023); Grossman joins Reunion Neuroscience board (Apr 2023) then Coya Therapeutics as President/CMO (Jul 2023).
Why it matters: Loss of both C-suite executives within months of a $22M launch is a critical red flag. No public explanation given. No replacement leadership announced. All development activity appears to have ceased. Psychedelic Alpha noted "Trouble at Empyrean?" in Bulletin #135.
Recorded Events
Feb 1, 2023: Company milestone
Dec 1, 2022: regulatory-milestone
Nov 18, 2022: Funding milestone
Evidence Links
company-website - Empyrean Neuroscience - Verified
PsiH+ (Engineered Psilocybin — Substance Use Disorders)
Genetically engineered psilocybin variant targeting substance use disorders. Part of broader 8-programme pipeline across 3 species (Psilocybe, iboga, cannabis). Additional named candidates: PsiD+ (treatment-resistant depression), PsiK+ (OCD), PsiX+ (panic disorder), DMT (engineered, MDD/PTSD/SUD). All preclinical. All effectively stalled since Feb 2023 leadership departures.
Quick Facts
- Type
- Private Biotech
- Founded
- 2019
- Lead Stage
- Pre-clinical
- Website
- Visit