Confidential Institutional Briefing

Repair the Brain.
Not the Trip.

Xycota is a preclinical CNS company advancing sub-perceptual (microdose) psilocybin designed to raise BDNF and drive durable neuroplastic repair over time, without the hallucinogenic experience. Our lead program targets mild PTSD, with a first-in-human study planned in Canada.

We are not chasing the trip. We are engineering the repair.

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Preclinical stage Peer-reviewed mechanism First-in-human planned, Canada
01The Problem

The Macrodose Bottleneck

To date, psychedelic medicine has been tested almost entirely as high-dose, hallucinogenic "macrodoses." That model carries structural problems that have slowed the entire field.

Functional unblinding

Because a macrodose produces an unmistakable altered state, patients and clinicians can tell who received the drug. That expectation bias confounds endpoints and has been cited among the reasons for recent regulatory pushback.

Unscalable delivery

Macrodose therapy can require up to eight hours of supervised sessions with two trained facilitators, in specialized clinics. That limits throughput, access, and cost-effectiveness.

Acute risk profile

The intense subjective experience carries risks of acute anxiety and psychological distress, requiring heavy screening and monitoring that most health systems cannot deploy at scale.

Benefit entangled with the trip

Conventional programs rely on the subjective "mystical" experience plus intensive psychotherapy. That makes it hard to know whether the biology alone can heal, or whether the trip is doing the work.

02The Thesis

Separate the Healing From the High

A growing body of preclinical science suggests psilocybin's therapeutic and hallucinogenic effects travel on different pathways. Xycota's thesis is that a repeated, sub-perceptual dose can engage the repair pathway, through a hormetic effect that builds over time, while leaving the trip behind. This is the hypothesis our programs are designed to test.

The Trip

5-HT2A activation

The acute hallucinogenic experience is associated with strong serotonin 5-HT2A receptor activation. It is the part of the dose that demands supervision, drives risk, and breaks the blind.

The Repair

BDNF / TrkB signaling

The structural, neuroplastic benefit is associated with the BDNF/TrkB pathway: more brain-derived neurotrophic factor, restored synaptic connectivity, and dendritic growth. Xycota is engineering for this, at doses designed to stay below the perceptual threshold.

Xycota's delivery and dosing claims are testable hypotheses to be validated experimentally, not an established advantage over conventional dosing.

03The Evidence

Peer-Reviewed Foundations

The mechanism at the center of our thesis is supported by recent, independent, peer-reviewed research. The work below studies animal models; it establishes biological plausibility for our approach, not clinical proof in humans.

Mechanism paper
Neuropsychopharmacology, 2026

Psilocybin microdosing rescued cognitive deficits in a validated neurodevelopmental rat model through modulation of the BDNF/TrkB signaling pathway.

Oral psilocybin microdosing rescued cognitive deficits in the model. Blocking the TrkB receptor abolished the effect, implicating BDNF/TrkB rather than serotonergic mechanisms. The authors frame microdosing as a way to dissociate structural benefit from the hallucinogenic effect.

Trezza, V., Hausman, M. S., et al. (2026)

Independent corroboration
Communications Biology, 2026

Psilocybin as a treatment for repetitive mild head injury: evidence from neuroradiology and molecular biology.

In a rat model of repetitive mild traumatic brain injury, psilocybin reduced phosphorylated tau and brain swelling, restored functional connectivity, and increased BDNF and TrkB. An independent group, not affiliated with Xycota, which strengthens the external validity of the mechanism.

Brengel, E. K., et al. (2026)

These studies were conducted in animal models. They support the biological rationale for Xycota's programs; they do not demonstrate safety or efficacy in humans.

04Lead Program

XYCO-02
Microdose Psilocybin for Mild PTSD

Status

Phase 1/2a Clinical Trial Preparation (Canada)

No completed human study has yet tested microdosing for PTSD. We intend to run a rigorous, double-blind, placebo-controlled study in mild PTSD. Here is why that endpoint would matter.

01

Solves functional unblinding

A sub-perceptual dose is intended to preserve a true double-blind, because participants should not be able to tell the drug from placebo. That is the gold-standard design regulators are asking for.

02

Isolates the biology

By removing the trip, the study is designed to test whether BDNF-driven neuroplasticity, on its own, is enough to move trauma symptoms, before the disorder becomes chronic and entrenched.

03

Safety and scalability

A sub-perceptual dose is intended to lower the acute risk profile and, if the data support it, to point toward a scalable, take-home model rather than eight-hour supervised clinic visits.

04

Built on Canadian precedent

Health Canada has recently supported rigorous sub-hallucinogenic research by other groups, including an at-home psilocybin microdose trial for generalized anxiety and low-dose psilocybin trials. We intend to advance mild PTSD through that same standard pharmaceutical pathway.

Other companies are advancing microdose and low-dose psilocybin in anxiety and depression. Xycota's aim is to be first to target mild PTSD with a sub-perceptual dose. The Canadian study is planned and subject to regulatory and ethics approvals that have not yet been granted.

05The Platform

One Mechanism, Many Doors

BDNF is central to neurogenesis, synaptic plasticity, and repair. If the PTSD endpoint reads out, the same mechanism opens a broad set of CNS indications. We are leading with the nearest, largest-market opportunity and sequencing the rest behind the data.

XYCO-02 Mild PTSD, lead clinical asset

Phase 1/2a Clinical Trial Preparation (Canada)

XYCO-02 is our lead clinical asset targeting mild PTSD via a sub-perceptual oral dosing protocol. Rather than utilizing standard, resource-intensive psychedelic supervision, XYCO-02 utilizes a decentralized, at-home trial design. This capital-efficient Phase 1/2a protocol is built directly upon proven regulatory and clinical frameworks previously successfully navigated with Health Canada and clinical IRBs by our executive leadership team.

XYCO-01 Frontotemporal Dementia (FTD)

Orphan Drug Designation (ODD) Filed / Pre-Clinical

Xycota has officially filed an Orphan Drug Designation application with the FDA for XYCO-01 in the treatment of Frontotemporal Dementia (FTD). In alignment with recent FDA feedback, Xycota is advancing into a targeted pre-clinical efficacy study utilizing validated FTD animal models. To optimize capital efficiency, this pre-clinical phase is scheduled to follow the clinical initiation of our lead program, XYCO-02.

Expansion

Traumatic Brain Injury

Neuroplastic repair after head trauma

Preclinical, mechanism-aligned

Expansion

Cognitive aging and other CNS

Age-related synaptic decline; depression and anxiety adjacencies

Exploratory

Parallel Delivery Strategy

Exosome-Engineered Delivery

Alongside the sub-perceptual free-psilocin protocol, Xycota is developing an exosome-engineered delivery approach: psilocin loaded into exosomes, naturally cell-derived delivery vesicles, designed to modulate how and where the compound acts inside the brain. This is the delivery approach behind our XYCO-01 (FTD) program and FDA Orphan Drug Designation filing.

Exosome delivery is a testable formulation strategy we plan to validate experimentally, not an established advantage over free compound. Both tracks converge on the same BDNF/TrkB repair biology.

06Execution

A Standard Pharmaceutical Path, in Canada

We are designing XYCO-02 for early human safety and signal generation under Canadian regulatory oversight and quality systems, through the conventional clinical-trial pathway rather than a specialty clinic model.

Design

Double-blind, placebo-controlled protocol built around the functional-unblinding advantage.

Oversight

Health Canada and research-ethics review, with GMP-grade material and quality systems.

Signal

Early human safety plus BDNF-linked biomarker and symptom endpoints in mild PTSD.

07Leadership and Science Board

Built for Diligence

Pharmaceutical execution and scientific authority, assembled to meet investor and acquirer standards.

Brad Listermann

Brad Listermann

President and CEO, Co-Founder

He leads corporate strategy, capital formation, and partnerships. A deep-technology builder, he has filed patents and led teams across cybersecurity, edge AI, cryptographic proof, and post-quantum resistant protection, and brings that engineering and IP discipline to Xycota. Business and partnership inquiries: brad@xycota.com.

Dr. Marvin S. Hausman, MD

Dr. Marvin S. Hausman, MD

Founder and Chief Scientific Officer

Five decades in CNS drug development, architect of six FDA-approved NDAs, and a prior orphan-drug designation holder. Scientific inquiries: marvin@xycota.com.

Dr. Viviana Trezza, PhD

Dr. Viviana Trezza, PhD

Lead Scientist, Co-Inventor

Associate Professor of Pharmacology at Roma Tre University and co-inventor. Lead author of the 2026 Neuropsychopharmacology study establishing Xycota's BDNF/TrkB mechanism.

Dr. Louise Hecker, PhD

Dr. Louise Hecker, PhD

Scientific Advisor

Neuroplasticity and aging-biology researcher at Baylor College of Medicine. Co-author of the 2025 npj Aging study on psilocin and cellular lifespan; advises the cognitive-aging direction.

Andrew Charrette, MSc

Andrew Charrette, MSc

CRO / Regulatory (KGK Science)

Clinical and regulatory lead via KGK Science, a Canadian CRO, guiding the North American program and the Health Canada pathway.

08Common Questions

Frequently Asked Questions

What is Xycota Biosciences?
Xycota is a preclinical CNS company developing sub-perceptual (microdose) psilocybin designed to raise BDNF and drive neuroplastic repair over time, without the hallucinogenic experience. Our guiding principle: we are not chasing the trip, we are engineering the repair.
How is a microdose different from standard psychedelic therapy?
Conventional programs use a high, hallucinogenic "macrodose" that requires long supervised sessions and makes trials hard to blind. Xycota's approach uses a repeated sub-perceptual dose intended to engage the BDNF/TrkB repair pathway while staying below the threshold of a noticeable psychedelic effect. Whether this works in humans is exactly what our programs are designed to test.
What is the scientific basis?
A 2026 Neuropsychopharmacology paper (Trezza, Hausman, et al.) showed psilocybin microdosing rescued cognitive deficits in a validated neurodevelopmental rat model through BDNF/TrkB signaling, not serotonergic mechanisms. An independent 2026 Communications Biology paper (Brengel et al.) found psilocybin raised BDNF and TrkB, lowered phosphorylated tau, and restored connectivity in a rat model of repetitive mild head injury. These are animal studies that support the rationale; they are not human proof.
What is the lead program, and why PTSD in Canada?
XYCO-02 is a microdose psilocybin candidate for mild PTSD, with a Phase 1/2a study in preparation in Canada. A sub-perceptual dose is intended to preserve a true double-blind (solving the functional-unblinding problem), isolate the BDNF mechanism, and lower risk. Health Canada has recently supported rigorous sub-hallucinogenic microdose research by other groups, which is the pathway we intend to use. The study is planned and not yet approved.
What happened to the FTD program?
Frontotemporal dementia is our XYCO-01 program, delivered via exosome-engineered psilocin. Xycota has filed an Orphan Drug Designation application with the FDA for XYCO-01 in FTD. In alignment with recent FDA feedback, the targeted pre-clinical efficacy study in validated FTD animal models is scheduled to follow the clinical initiation of our lead program, XYCO-02 (mild PTSD), to optimize capital efficiency.
Is Xycota a psychedelic company?
No. Xycota is a precision CNS drug company. The goal is durable neuroplastic repair through controlled, sub-perceptual pharmacology, not an acute psychedelic experience.
How can I learn more or discuss partnership?
Detailed materials are shared with qualified investors and partners under NDA. Use the Request Data Room Access button, or contact the leadership team below.

This page is for general informational purposes only and is not medical advice. Psilocybin is an investigational, controlled substance; nothing here should be used to guide self-treatment. Consult a qualified professional for medical advice or diagnosis.

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