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Research, Drug Development & Manufacturing
Research, Drug Development & ManufacturingCompany-Led Drug Development & CommercializationEarly-Stage Translational Research (Pre-Clinical)
Research, Drug Development & ManufacturingCompany-Led Drug Development & Commercialization
Lead program: Pre-clinical

Xylo Bio

Also known as: Psylo

1 Drug Candidate

Xylo Bio (formerly Psylo) is an Australian-US biotech developing next-generation neuroplasticity-promoting therapeutics for mental health. Founded in 2021 by Josh Ismin and Sam Banister in Sydney, the company has labs at the University of Colorado Boulder and the University of New South Wales. Its lead candidate PSYLO-100X is a non-hallucinogenic compound designed for home administration without clinical supervision, advancing through IND-enabling studies toward first-in-human trials. Xylo has raised $14.2M including an $8M seed round in June 2024 from Tenmile, Focalpoint Partners, and Palo Santo.

Development Programmes

1

XYL-1001 (formerly PSYLO-100X)

Pre-clinical
Major Depressive Disorder (MDD)Anxiety Disorders

Depression, anxiety, ruminative disorders — non-hallucinogenic 5-HT2A-selective neuroplastogen

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Pre-clinicalActive

IND-enabling studies funded by $8M Series Seed. Manufacturing scale-up underway. Labs at University of Colorado Boulder and UNSW Sydney. First-in-human trials planned mid-2026. Rebranded from Psylo to Xylo Bio (January 2025).

Milestones

Pre-clinical completed

In progress

Manufacturing scale-up initiated; preclinical efficacy data (antidepressant-like effects, neuroplasticity, pro-cognitive) reported

Why it matters: Positive preclinical data and manufacturing progress support the mid-2026 FIH timeline. The non-hallucinogenic, 5-HT2A-selective, 5-HT2B-sparing profile is the key differentiator in a crowded neuroplastogen field.

Watch next: IND-enabling tox completion and FDA IND filing

Funding milestone

Completed

Actual: Jun 3, 2024

First close on $8M Series Seed financing announced at BIO Conference San Diego

Why it matters: The $8M seed funds IND-enabling studies and manufacturing scale-up for XYL-1001 (then PSYLO-100X). Xylo Bio's computationally enhanced drug discovery platform identified XYL-1001 as a non-hallucinogenic 5-HT2A-selective neuroplastogen that avoids 5-HT2B activation (reducing cardiac risk) while preserving antidepressant-like efficacy and pro-cognitive effects in preclinical models.

Watch next: IND filing and FIH study initiation mid-2026

Company milestone

Completed

Actual: Jan 1, 2025

Rebranded from Psylo to Xylo Bio; key board appointments; restructured as US Delaware C-corp

Why it matters: US reincorporation and rebrand position the company for US IND filing and institutional fundraising. Board appointments signal expansion from academic origins toward clinical-stage drug development.

Recorded Events

Jan 1, 2025: Company milestone

Jun 3, 2024: Funding milestone

Quick Facts

Type
Private Biotech
Founded
2021
Lead Stage
Pre-clinical
Website
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