Leading the Industry in Developing Proprietary Psychedelic-Based Therapeutics

Research and Development Progress

PROGRAM(1) (2)
CYB003-Deuterated Psilocybin Analog

Major Depressive Disorder

Phase 1/2a trial underway
CYB004-Deuterated Dimethyltryptamine (dDMT)

Generalized Anxiety Disorder

CYB004-E Phase 1 trial underway
CYB003-Deuterated Psilocybin Analog

Alcohol Use Disorder

PHASE 1
CYB005-Phenethylamine Derivative

Neuroinflammation

PRECLINICAL
CYB002 – Amorphous Psilocybin ODT

Undisclosed

PRECLINICAL
Other

Undisclosed

PRECLINICAL
Mental Distress in Healthcare Workers 3

EMBARK – Psilocybin for mental distress in frontline healthcare workers

Phase 2 IIT study underway
Psychedelic Effects On Brain4

Kernel Flow - Neuroimaging Technology

Feasibility study completed

Q3 2022

CYB003 Phase 1/2a MDD patient study

Initiated CYB003 Phase 1/2a MDD patient study

.

Q4 2022

Preclinical data expected for CYB005

Potential CYB003 interim safety and PK data readout

Expect data from Phase 1 Kernel Flow® feasibility study

Plan to nominate CYB005 partnering candidate

               NOTES:

  1. Forward-looking statements are subject to risks and assumptions. 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.
  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.

Q3 2022

Initiate CYB003 Phase 1/2a MDD patient study

Continue to progress CYB004-E Phase 1 clinical trial

.

Q4 2022

Preclinical data expected for CYB005

Potential CYB003 interim safety and PK data readout

Expect data from Phase 1 Kernel Flow® feasibility study

Plan to nominate CYB005 partnering candidate

Value-Driving Milestones

Q1 2023

Completed CYB003 Phase 1 to assess safety, PK and psychedelic effects

Initiated CYB003 dosing in MDD Phase 2a cohorts

First-in-human dosing of CYB004 approved

Initiated DMT (Part B) dosing in CYB004-E study

Q2 2023

Completed Part B (DMT) dosing in CYB004-E study

Completed GMP manufacturing for CYB004

Initiated CYB004 first-in-human dosing

Initiate bioequivalence cohort for CYB003 for capsules

Q3 2023

Complete CYB003 dosing in MDD cohorts

Topline data readout from CYB004-E trial, including DMT and CYB004 cohorts

Topline data readout from CYB003 Phase 1/2a clinical trial (late Q3)

.

Q4 2023

FDA submission of CYB003 Phase 1/2a for pivotal studies

2022 HIGHLIGHTS

ANTICIPATED MILESTONES(1)

Initiated Phase 1/2a first-in-human clinical trial evaluating CYB003 for treatment of MDD

Interim safety & PK readout expected in early CY2023

Accelerated development of CYB004 through acquisition of Phase 1 clinical trial evaluating IV DMT

Update expected in early CY2023

Supported investigator-initiated Phase 2 study evaluating EMBARK psychedelic facilitator training program in combination with psilocybin to treat frontline healthcare workers

Expand EMBARK training to support psychedelic-based therapies

Initiated co-sponsored feasibility study evaluating Kernel Flow quantitative neuroimaging technology to measure psychedelic effects on brain

Data expected first quarter CY2023 to inform next steps

2022 HIGHLIGHTS

ANTICIPATED MILESTONES(1)

Initiated Phase 1/2a first-in-human clinical trial evaluating CYB003 for treatment of MDD

Interim safety & PK readout expected in early CY2023

Accelerated development of CYB004 through acquisition of Phase 1 clinical trial evaluating IV DMT

Update expected in early CY2023

Supported investigator-initiated Phase 2 study evaluating EMBARK psychedelic facilitator training program in combination with psilocybin to treat frontline healthcare workers

Expand EMBARK training to support psychedelic-based therapies

Initiated co-sponsored feasibility study evaluating Kernel Flow quantitative neuroimaging technology to measure psychedelic effects on brain

Data expected first quarter CY2023 to inform next steps

Lead Clinical Development Programs

CYB003: Deuterated Psilocybin Analog

CYB003 is a proprietary molecule derived from psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters like serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocybin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog being developed to achieve low variability in plasma levels, and fast onset and short duration of effect, at low doses to potentially provide a safer and more effective outcome for patients and providers.

CYB003 is being evaluated as a potential treatment for Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD) and is the first ever deuterated psilocybin analog to enter clinical development.

Current Status: Positive interim data for Phase 1/2a trial released; Topline efficacy data expected in Q4 2023

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CYB004: Deuterated N,N Dimethyltryptamine (dDMT)

CYB004 is a deuterated dimethyltryptamine (dDMT), which has been shown to exert its psychedelic effects by activating the 5-HT2A receptor. In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT.  Based on preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic profile in comparison to DMT when administered via intravenous and inhaled routes. These studies also demonstrated that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer less invasive and more convenient dosing methods.

CYB004 is being evaluated as a potential treatment for anxiety disorders, specifically Generalized Anxiety Disorder.  CYB004 is secured by a U.S. composition of matter patent with protection through 2041.  The patent covers a range of deuteration forms of DMT and protects CYB004 as a putative new chemical entity.

Current status: Phase 1 CYB004-E clinical trial underway evaluating IV DMT and CYB004 in healthy volunteers; Topline data expected in Q3 2023

CYB004: Deuterated Dimethyltryptamine (DMT)

CYB004 is a deuterated dimethyltryptamine (DMT), which has been shown to exert its psychedelic effects by activating the 5-HT2A receptor. In its natural form, DMT is rapidly metabolized in the body, unstable and not orally bioavailable. Based on preclinical studies, deuterated DMT has the potential to overcome these limitations and provide increased oral and pulmonary bioavailability, faster onset with lower doses, less patient variability, and better dose titration for fewer side effects and longer acting desensitization of the serotonergic receptors. CYB004 has the potential to effectively treat Generalized Anxiety Disorder with or without major depressive disorder.

Current status: Conducting Phase 1 in-human study evaluating 50 healthy volunteers 

CYB004: Deuterated N,N Dimethyltryptamine (dDMT)

CYB004 is a deuterated dimethyltryptamine (dDMT), which has been shown to exert its psychedelic effects by activating the 5-HT2A receptor. In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT.  Based on preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic profile in comparison to DMT when administered via intravenous and inhaled routes. These studies also demonstrated that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer less invasive and more convenient dosing methods.

CYB004 is being evaluated as a potential treatment for anxiety disorders, specifically Generalized Anxiety Disorder.  CYB004 is secured by a U.S. composition of matter patent with protection through 2041.  The patent covers a range of deuteration forms of DMT and protects CYB004 as a putative new chemical entity.

Current status: Phase 1 CYB004-E clinical trial underway evaluating IV DMT and CYB004 in health volunteers; Topline data expected in Q3 2023

Our Work

Patents

Cybin has multiple patent filings covering 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.

These 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. 

Cybin was granted a patent by the USPTO for CYB004, its proprietary deuterated DMT molecule, in February 2022.  The allowed claims include a range of deuterated forms of DMT and 5-MeO-DMT, and protects CYB004 drug substance as a putative new chemical entity.

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 pharmacokinetics 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 of action.

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.

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.