Development Pipeline
Leader in Developing Differentiated,
Next-Generation Therapeutics
Innovative Neuropsychiatry Pipeline of 5-HT Receptor Agonists with Clinical Validation and Value-Driving Milestones
- Program
- INDICATION
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- NEXT MILESTONES1,2
CYB003
Deuterated
Psilocin
(Oral)
Adjunctive treatment of Major Depressive Disorder (MDD)
Mid-2025: Initiate second pivotal study, EMBRACE
CYB004
Deuterated
Dimethyltryptamine
(Intramuscular)
Generalized Anxiety Disorder
(GAD)
Mid-2025: Phase 2 GAD topline data
CYB005
Phenethylamines
(Non-hallucinogenic
doses)
CNS Disorders
DMT/d-DMT
Program
CYB004-Deuterated Dimethyltryptamine (IM)
Generalized Anxiety Disorder
SPL028- Deuterated DMT
(IM and IV)
SPL026 – DMT
(IM and IV)
Major Depressive Disorder
NOTES:
1) Forward-looking statements are subject to risks and assumptions.
2) 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 psilocin and other analogues.
Near-term Value-Driving Milestones
Q2 2024
Initiated Phase 2 trial of CYB004 (IM) in GAD
Q3 2024
Initiate Phase 3 multisite, multinational study of CYB003 in MDD summer 2024
Q4 2024
Topline efficacy data readout from CYB004 (IM) Phase 2 clinical trial in GAD
We Are an Advanced Clinical-Stage Neuropsychiatry Company Approaching Key Near-Term Milestones
1) Two proprietary clinical programs targeting depression and anxiety disorders with positive Phase 2 safety and efficacy results
2) Lead program CYB003, which has been granted FDA Breakthrough Therapy Designation, is in Phase 3 development for the adjunctive treatment of MDD1
3) Robust pipeline of differentiated assets with potential for expansion into additional neuropsychiatry indications with high unmet need affecting >200M people in the U.S.2
4) Strong Intellectual Property Portfolio with over 80 granted patents and over 230 patent applications pending
5) Well-capitalized to move programs forward with cash position of C$136.3 million as of December 31, 2024
NOTES:
1) Forward-looking statements are subject to risks and assumptions.
2) Based on estimated addressable markets for indications including depression, anxiety disorders/PTSD, bipolar disorder, substance use/addiction, eating disorders, cluster headaches/migraine, and chronic pain management
Lead Clinical Development Programs
CYB003: Deuterated Psilocybin Analog Program designated as a Breakthrough Therapy by the FDA.
CYB003 is a proprietary molecule derived from psilocin, which is part of a family of molecules called indolamines that includes more common neurotransmitters like serotonin. Psilocin produces pharmacological effects by activating the serotonin 5-HT2A receptor. CYB003 is being developed to potentially provide a safer and more effective outcome for patients and providers.
CYB003 has received the first known FDA Breakthrough Therapy Designation for an adjunctive tryptamine-based therapy for MDD, expediting the clinical development timeline and the regulatory pathway towards potential approval.
Development status: Initiated Phase 3 PARADIGM program evaluating CYB003 in participants with moderate to severe MDD
Upcoming milestones: Initiate second pivotal study, EMBRACE around mid-2025
For more details on the Company’s CYB003 program, please visit the CYB003 Page.
CYB004: Deuterated DMT Program:
CYB004, Cybin’s proprietary deuterated N, N -dimethyltryptamine (“dDMT”) progam, is in development for the potential treatment for Generalized Anxiety Disorder (“GAD”). CYB004 is protected by a U.S. composition of matter patent expected to provide coverage until at least 2041.
Cybin has leveraged clinical data from its completed DMT and dDMT trials, which collectively form the most advanced and extensive DMT/dDMT data portfolio in the neuropsychiatry drug development sector, to optimize the development of the CYB004 program. To date, Cybin has completed five clinical trials across several molecules: CYB004 (IV dDMT), SPL028 (IV/IM dDMT), SPL026 (IV/IM DMT), and DMT, demonstrating proof-of-concept in treating depression, supporting the development of dDMT for the treatment of anxiety disorders, and providing important dosing insights.
Key findings from these completed studies are as follows:
Completed Study
Key Findings
Completed Study
(1) Phase 1/2a DMT study in
moderate to severe MDD (no SSRIs)
(2) Phase 1 IV/IM DMT study
(3) Phase 1 SSRI DDI study
(4) Phase 1 Study of IV CYB004 (dDMT) and IV DMT
(5) Phase 1 IM/IV dDMT study
Key Findings
(1) Phase 1/2a DMT study in moderate to severe MDD (no SSRIs)
(2) Phase 1 IV/IM DMT study
(3) Phase 1 SSRI DDI study
(4) Phase 1 Study of IV CYB004 (dDMT) and IV DMT
(5) Phase 1 IM/IV dDMT study
DMT demonstrated rapid and durable antidepressant and anxiolytic effect
✓46% of MDD patients in remission at 3 months
✓40% of MDD patients in remission at 6 months
✓Rapid improvement in anxiety and wellbeing scores
✓IV DMT safe and well-tolerated
Characterized safe and well-tolerated IM route and dose selection for DMT and dDMT
DMT safe and well-tolerated when co-administered with SSRIs
Potential enhanced effect when given as adjunctive to SSRIs:
✓92% remission rate in SSRI cohort vs. 20% remission (non-SSRI cohort)
DMT demonstrated rapid and durable antidepressant and anxiolytic effect
✓46% of MDD patients in remission at 3 months
✓40% of MDD patients in remission at 6 months
✓Rapid improvement in anxiety and wellbeing scores
✓IV DMT safe and well-tolerated
Characterized safe and well-tolerated IM route and dose selection for DMT and dDMT
DMT safe and well-tolerated when co-administered with SSRIs
Potential enhanced effect when given as adjunctive to SSRIs:
✓92% remission rate in SSRI cohort vs. 20% remission (non-SSRI cohort)
Development status: Dosing underway in Phase 2 proof-of-concept study of CYB004 in Generalized Anxiety Disorder (“GAD”) in the United States
Upcoming milestones: Phase 2 CYB004 safety and efficacy data in GAD expected in mid-2025.
For more details on the Company’s DMT/dDMT program, please visit the CYB004 page
