Leaders in Developing Differentiated,
Next-Generation Psychedelic Therapeutics

PROGRAM(1) (2) (3)
Psilocybin Program
CYB003-Deuterated Psilocybin Analog

Major Depressive Disorder

Phase 1/2a complete
CYB003-Deuterated Psilocybin Analog

Alcohol Use Disorder

DMT/d-DMT Program
CYB004-Deuterated Dimethyltryptamine

Generalized Anxiety Disorder

Phase 2 Cleared to proceed by FDA
SPL028- Injectable deuterated DMT
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)​
CYB005-Phenethylamine Derivative



  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 psilocybin and other analogues.

Near-term Value-Driving Milestones

Q1 2024 – Completed

Topline data readout from Phase 1 CYB004-E study (IV DMT and CYB004)

Topline data readout from SPL028 Phase 1 IM/IV study

Q1 2024

Phase 2 CYB003 long-term 3-month efficacy data in MDD ​

FDA end of Phase 2 meeting for CYB003

Initiate Phase 2 trial of​ CYB004 in GAD

Q2 2024

Initiate Phase 3 multisite, multinational study of CYB003 in MDD


Q4 2024

Topline efficacy data readout from CYB004 Phase 2a clinical trial in GAD​​

Lead Clinical Development Programs

Deuterated Psilocybin Analog Program

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 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).

Current status: Positive Phase 2 topline data in MDD released

Upcoming milestones:

Additional Phase 2 data assessing long-term efficacy for CYB003 at 3 months expected in Q1 2024

FDA end of Phase 2 meeting in early 2024

Initiate Phase 3 trial of CYB003 in MDD in Q2 2024

N,N-Dimethyltryptamine (DMT) Program (CYB004, SPL028, SPL026)

Cybin’s portfolio includes the most advanced and extensive DMT dataset in the psychedelic drug development sector. The Company’s DMT portfolio is comprised of deuterated DMT (“dDMT”) molecules CYB004 and SPL028, which have the potential for less invasive, more convenient and patient-friendly dosing methods, in addition to SPL026, intravenous (“IV”) DMT.

CYB004, Cybin’s proprietary dDMT molecule, is being evaluated as a potential treatment for Generalized Anxiety Disorder. CYB004 is protected by a U.S. composition of matter patent expected to provide coverage until at least 2041.

The Company has completed multiple clinical trials providing proof-of-concept for its DMT/dDMT assets, including:

Phase 2a safety and efficacy for SPL026 (IV DMT) in 34 participants with MDD, demonstrating a clinically relevant and statistically significant reduction in depression symptoms at two weeks after dosing (-7.4 point difference in MADRS between SPL026 and placebo). Durable antidepressant response and remission rates were observed at 6 months. Among participants who had achieved remission within three months with SPL026, 64% sustained remission to 6 months.
Phase 1 studies evaluating intramuscular (“IM”) SPL026 and SPL028 supporting IM administration for patient-friendly dosing. The completed Phase 1 study of IV/IM SPL028 in healthy volunteers showed that SPL028 is safe and well-tolerated, and demonstrated that IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects
Phase 1b study evaluating the safety and efficacy of SPL026 in conjunction with SSRIs in 17 participants with MDD, demonstrating no relevant drug-drug interactions, a favorable safety profile and enhanced efficacy when SPL026 was administered with SSRIs, and a 92% remission rate at 4 weeks in the DMT + SSRI combination cohort (n=12). Phase 1 topline data for IV CYB004 demonstrated robust and rapid-onset psychedelic effects at lower doses compared to native DMT, suggesting potential as a short-acting, scalable treatment

Exploratory analysis of data from these studies also shows significant improvements in symptoms of anxiety, as measured using the State Trait Anxiety Inventory – Trait version (STAI-T), with a 22 point improvement from baseline at the 2 week endpoint, in the DMT+SSRI combination group.

Current status: Phase 1 CYB004 and Phase 1 IM/IV SPL028 studies complete with a Phase 2 study in Generalized Anxiety Disorder (“GAD”) in the United States expected to begin in Q1 2024.