Development Pipeline
Leaders in Developing Differentiated,
Next-Generation Therapeutics
PROGRAM(1) (2) (3)
- DISCOVERY
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- REGISTRATION
Deuterated
Psilocybin
Program
CYB003-Deuterated Psilocybin Analog
Major Depressive Disorder
CYB003-Deuterated Psilocybin Analog
Alcohol Use Disorder
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. See “Cautionary Statement” on page 2 of this presentation.
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 psilocybin and other analogues.
3)Cybin is prioritizing the progression of its CYB003 program. The advancement of Cybin’s CYB004 and technology programs are all contingent on Cybin’s ability to continue raising capital under its current and future financing arrangements. No assurances can be given that Cybin will be able to raise the additional capital that it may require for its anticipated future development.
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
Lead Clinical Development Programs
CYB003: Deuterated Psilocybin Analog Program designated as a Breakthrough Therapy by the FDA.
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 its active metabolite, psilocin, which is responsible for its pharmacological effects by activating the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog 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 psychedelic-based therapy for MDD, expediting the clinical development timeline and the regulatory pathway towards potential approval.
Development status: Positive Phase 2 topline data in MDD released
Upcoming milestones:
Initiate Phase 3 trial of CYB003 in MDD summer 2024
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”) molecule, 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 psychedelic drug development sector, to optimize the development of the CYB004 program. To date, Cybin has completed five clinical trials across four 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:
Phase 2a safety and efficacy for IV SPL026 (DMT) in MDD
Rapid, robust antidepressant effect with -7.4 point difference between SPL026 (21.5mg) and placebo at 2 weeks after dosing as measured by MADRS change from baseline (p=0.02)
Durable effect with 46% of MDD patients in remission at 3 months and 40% of MDD patients in remission at 6 months
Favorable safety and tolerability in MDD patients
Rapid improvement in anxiety and wellbeing scores
Phase 1 study evaluating intramuscular (“IM”) SPL026 supporting patient-friendly dosing
IM DMT is well-tolerated and generates a breakthrough psychedelic experience (~45 min)
Phase 1 study evaluating IM SPL028 supporting patient-friendly dosing
IM dDMT dose is well-tolerated and generates breakthrough psychedelic experience (average ~90 min)
Phase 1b study evaluating the safety and efficacy of SPL026 in MDD in conjunction with SSRIs
Potential enhanced effect when given as adjunctive to SSRIs: 92% remission rate in SSRI cohort vs. 20% remission (non-SSRI cohort)
DMT safe and well-tolerated when co-administered with SSRIs
Improvement in symptoms of anxiety: at two weeks, participants on SPL026+SSRIs showed a mean 23-point improvement from baseline on the State Trait Anxiety Inventory – Trait version (STAI-T).
Phase 1 study evaluating IV DMT and IV CYB004
90 min DMT infusion was well tolerated with strong psychedelic effects at the highest dose
DMT bolus + infusion provided sustained psychedelic effects over an extended period of time
IV CYB004 (dDMT) is well-tolerated and generates breakthrough psychedelic experience (~40 min)
Development status: Initiated 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 year end 2024
For more details on the Company’s DMT/dDMT program, please visit the CYB004 page.
