Leading the Industry in Therapeutic Development Programs and Innovative Drug Delivery Systems

Our 3 Pillar Strategy

1
 

Novel Drug Discovery Platform

API Modification

Develop new API’s via selective modifications of tryptamine and phenethylamine-based scaffolds specifically to alter their pharma cokinetics without modifying their therapeutic potential.

Modifications involve replacing selective hydrogens with deuterium atoms.

Optimizing unique physicochemical attributes e.g. salts, crystal forms, co-crystals, etc.

2
 

Proprietary Drug Delivery Systems

Research and Development

Efficient delivery system that attempts to bypass the liver metabolism with a direct path to the brain providing a faster onset.

Modified-release formulations with the potential to reduce side effects and to control exposure.

Dose control through proprietary device platform.

Delivery systems may be applied to many psychedelic compounds.

3
 

Innovative Treatment Regimen

Science Meets Technology

Software-based platform to gather clinical research data from psychedelic treatment.

EMBARK six domain best-practices psychotherapy program designed to provide consistent therapist training and consistent psychotherapy delivery in clinical trials.

Patents

15 patent filings cover a wide range of novel psychedelic compounds from different classes, including targeted structural modifications to improve the drug pharmacokinetic characteristics and safety profiles without altering their receptor binding. Novel drug delivery platform claims are expected to enable administration of the psychedelic drugs with faster onset of action, higher bioavailability by way of bypassing the liver metabolism and expected to offer more control for better patient experience and optimized therapeutic outcomes.

Advancing Mental Healthcare Through Evidence Based Therapeutics

CYB001

PHASE IIA & PHASE IIB CLINICAL TRIAL

SUBLINGUAL PSILOCYBIN IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER (MDD)
PHASE IIA
Randomized Parallel Group Open Label BE Study
PSILOCYBIN (PY)
SUBLINGUAL FILM
1MG
3MG
5MG
7MG
8
8
8
8
CAPS
25MG
8
TOTAL PATIENTS
40
PHASE IIB
Randomized Double Blind Placebo Controlled Safety & Efficacy Study
SELECTED DOSE PY SUBLINGUAL FILM
80
PLACEBO
40
TOTAL PATIENTS
120

MDD patients with moderate depression (MADRS score 18-34)

Primary efficacy in 30 days

Patients will be followed for 4 months for safety and efficacy

Duration: approx 12 months

Clinical trial will adhere to ICH and GCP guidelines, with the aim to utilize clinical data in jurisdictions such as USA, Canada and Europe.

Research and Development Pipeline

PROGRAM1
COVID-19 Distress2

EMBARK – Psilocybin for mental distress in frontline healthcare workers

PHASE 2
Psychedelic Effects On Brain3

Kernel Flow - Neuroimaging Technology

PHASE 1
Major Depressive Disorder

CYB003 - Deuterated Psilocybin Analog

PRECLINICAL
Alcohol Use Disorder

CYB003 - Deuterated Psilocybin Analog

PRECLINICAL
Anxiety Disorders

CYB004-Deuterated Dimethyltryptamine (DMT)

PRECLINICAL
Neuroinflammation

CYB005-Phenethylamine Derivative

PRECLINICAL

Clinical Alliances

PROGRAM1
University of Washington2

Psychedelic-assisted psychotherapy with psilocybin for COVID-19 distress in frontline healthcare workers

EXECUTING
Kernel Technology3

Measuring ketamine’s psychedelic effect on cerebral cortex hemodynamics

EXECUTING
Northwell Health, Lenox Hill Hospital

Psychedelic treatment for underserved communities and COVID-19 distress in frontline workers; EMBARK training for clinicians

EXECUTING
NOTES:
  1. Subject to receipt of all necessary regulatory approvals from all applicable governmental authorities, including, as applicable, the academic and scientific organizations with which Cybin is working. There are multiple risk factors regarding the ability to successfully commercially scale a chemically synthesized process to obtain psilocybin and other analogues.
  2. Phase 2 investigator-initiated study being conducted by Dr. Anthony Back, professor of medicine (oncology) at the UW School of Medicine and co-funded by Cybin.
  3. Cybin-sponsored Phase 1 feasibility study evaluating Kernel’s Flow Technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.