Psilera

Actual: Jan 15, 2024

Psilera announces bvFTD as lead indication for PSIL-006 — first psychedelic-derived compound specifically targeting frontotemporal dementia.

Why it matters: bvFTD is a rapidly fatal neurodegenerative disease with no approved treatments. Selecting bvFTD as lead indication signals confidence in the tau-model data and differentiates Psilera from the crowded depression/PTSD space.

Actual: Aug 15, 2024

Positive in vivo results in humanized tau mouse model of FTD: PSIL-006 improved sleep patterns, learning, and memory. Positive MTD/safety readouts confirmed. Non-hallucinogenic profile maintained.

Why it matters: First preclinical efficacy signal for a non-hallucinogenic psilocybin derivative in neurodegeneration. Multi-domain improvement (sleep + cognition) suggests broad neuroprotective mechanism beyond isolated endpoints.

Actual: Sep 5, 2024

USF Research Foundation invests $200K and publicly endorses PSIL-006 FTD research. Co-founders are USF alumni.

Why it matters: University endorsement and investment validates the science from Psilera's academic origin institution. Provides non-dilutive capital for IND-enabling work.

Actual: Jan 15, 2025

Psilera hosts first FTD Research Summit in Tampa — convening researchers, academics, and patient advocacy groups (including AFTD) to advance FTD treatment strategies.

Why it matters: KOL engagement and AFTD participation builds the clinical and advocacy network needed for a rare disease program. FTD-specific summit positions Psilera as a thought leader in this therapeutic space.

Actual: Feb 20, 2025

Psilera licenses entire DMT patent portfolio to atai Life Sciences (now AtaiBeckley) — upfront payment plus milestones and royalties. Provides Psilera with royalty stream from atai's DMT depression programs (likely VLS-01 for TRD).

Why it matters: Strategic refocus: monetizes legacy DMT IP to fund PSIL-006 FTD development. Creates passive revenue stream from atai's Phase 2 DMT programs without diluting Psilera equity.

Actual: Jun 9, 2025

Strategic collaboration with Hesperos Inc. to evaluate PSIL-006 on their Human-on-a-Chip platform — using patient-derived iPSCs in multi-organ microfluidic systems to model PSIL-006 efficacy and safety in neurodegeneration-relevant neural tissues.

Why it matters: Organ-on-a-chip technology provides human-relevant preclinical data beyond rodent models. For a rare disease like bvFTD where patient recruitment is inherently limited, advanced in vitro modeling strengthens the IND package and supports FDA engagement.

Actual: Jan 8, 2026

Dr. Magali Haas (MD/PhD) appointed CMO. Former Founder/CEO of Cohen Veterans Bioscience; 10+ years at J&J. Company states "poised to advance key assets into the clinic within the next 12 months."

Why it matters: CMO appointment signals imminent IND filing and Phase 1 planning. Haas's experience at Cohen Veterans Bioscience (a leading military mental health research org) and J&J provides the clinical development leadership needed for the transition from preclinical to clinical stage.

Actual: May 28, 2026

Psilera closed an oversubscribed $8.8M seed round to fund PSIL-006 IND-enabling work and clinical entry.

Why it matters: Extends runway and clarifies that PSIL-006 first-in-human timing has moved toward 2027 rather than a 2026 clinical start.

Watch next: IND filing/clearance and first Phase 1 study registration.

Actual: May 17, 2024

External drug-development references list PSIL-025 as a Psilera preclinical candidate for anxiety disorders.

Why it matters: Confirms PSIL-025 belongs in the active preclinical pipeline, but also highlights that it trails PSIL-006 in public development maturity.

Watch next: Mechanism disclosure, IND-enabling update, or deprioritization relative to PSIL-006.

Actual: Oct 3, 2025

Psilera secures $2M NIH/NIAAA SBIR grant (3-year term) to advance novel non-hallucinogenic psilocybin derivative toward IND for alcohol use disorder.

Why it matters: NIH peer-reviewed grant validates the scientific approach and provides 3 years of non-dilutive IND-enabling funding. Expands Psilera's therapeutic scope beyond neurodegeneration into addiction.