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)

Phase 3 PARADIGM program initiated Granted FDA BTD

Mid-2025: Initiate second pivotal study, EMBRACE

CYB004
Deuterated
Dimethyltryptamine
(Intramuscular)

Generalized Anxiety Disorder
(GAD)

Phase 2 study dosing underway

Mid-2025: Phase 2 GAD topline data

CYB005 Phenethylamines
(Non-hallucinogenic
doses)

CNS Disorders

Preclinical
DMT/d-DMT
Program
CYB004-Deuterated Dimethyltryptamine (IM)

Generalized Anxiety Disorder

Phase 2 GAD study initiated
SPL028- Deuterated DMT
(IM and IV)
Phase 1 IM & IV complete
SPL026 – DMT
(IM and IV)

Major Depressive Disorder

Completed: Phase 1 (IM), Phase 1b SSRI-DDI (IV), Phase 1/2a in MDD (IV)​

 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, and 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: over 80 granted patents, 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

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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

 (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)

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