Cybin Inc. outlined its recent positive Phase 2 CYB003 topline results in MDD and near-term milestones across its clinical-stage deuterated psilocybin and dDMT programs in development for the treatment of multiple mental health conditions. The Company completed a Phase 1/2a study evaluating CYB003, a proprietary deuterated psilocybin analog, as an adjunctive therapy in participants with moderate to severe MDD. The Phase 2 results, which showed robust improvements in depression symptoms after single doses of CYB003, and a 79% remission rate from depression symptoms at six weeks after two doses of CYB003 (12mg), support progression to a multinational, multisite Phase 3 trial in early 2024.

The CYB003 program is supported by two composition of matter patents expected to provide coverage until at least 2041. Summary of CYB003 Phase 2 topline efficacy data: 79% of patients remained in remission from their depression 6 weeks after receiving two doses of CYB003 (12mg). Rapid and large improvements in symptoms of depression observed after single doses of CYB003: A mean -13.75 point difference in Montgomery?Asberg Depression Rating Scale score (?MADRS?) between CYB003 (12mg and 16mg cohorts pooled) and placebo which is statistically significant at 3 weeks (p<0.0001).

Clear incremental benefit of a second dose: Incremental and sustained benefit seen as a further 5.8 point improvement on the MADRS total score with a second dose of CYB003 (12mg) at 6 weeks. Magnitude of improvement far superior compared to approved antidepressants and recently reported data with other psychedelics: Effects translate into unprecedented effect size (Cohen?s d > 2) (SSRIs = 0.243). These results compare favorably to pooled data from 232 industry studies of current standard of care antidepressants, selective serotonin reuptake inhibitors (?SSRIs?), submitted to U.S. Food and Drug Administration (?FDA?) which show an average improvement of 1.82 points on the MADRS total score vs.

placebo. Demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self?limiting. Upcoming Milestones for CYB003 Program: Additional Phase 2 data assessing durability of efficacy for CYB003 at 12 weeks expected in first quarter of 2024.

FDA end of Phase 2 meeting in early 2024. Initiate Phase 3 trial of CYB003 in MDD in early 2024, with recruiting expected to begin around the end of first quarter of 2024. 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 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 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).

A 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, with Phase 1 IM/IV SPL028 data expected early first quarter of 2024.

Phase 1b study evaluating the safety and efficacy of SPL026 in conjunction with SSRIs in 17 participants with MDD, demonstrating a favorable safety profile and enhanced efficacy when SPL026 was administered with SSRIs, and a 92% remission rate at 4 weeks in the SSRI cohort (n=12). Phase 1 study evaluating safety, dosing, and pharmacokinetics (?PK?) and pharmacodynamics (?PD?) of IV DMT and CYB004, with upcoming data expected to inform next steps for Phase 2. Upcoming Milestones for dDMT Program: Phase 1 topline data for CYB004 expected early first quarter of 2024. Phase 1 data for IM/IV SPL028 expected early first quarter of 2024.

Initiate Phase 2 GAD study in first quarter of 2024.