Cybin Inc. announced that the FDA has granted BTD to CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of MDD. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD. The Company also announced that its Phase 2 trial of CYB003 in MDD demonstrated robust and sustained improvement in depression symptoms at four months with 75% of participants receiving two 16mg doses achieving remission and no longer showing signs of depression.

These significant milestones reflect the Company's commitment to advancing cutting-edge treatment options for MDD, marking a transformational moment in the pursuit of regulatory approval. BTD provides an expedited review pathway, as well as increased access to FDA guidance on trial design, with the potential to reduce drug development timelines. It is reserved for drug candidates that target serious conditions and demonstrate substantial improvement on a clinically significant endpoint over available therapies.

The designation includes all "fast track" program features, as well as more intensive FDA guidance and discussion of the CYB003 development program, including planned clinical trials and plans for expediting the manufacturing development strategy. The designation of CYB003 as a breakthrough therapy acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003's potential for significant improvements over existing therapies. BTD serves as validation of the Company's progress to date and is expected to accelerate Cybin's mission to advance its proprietary next- generation treatment towards new drug approval on an expedited basis.

This designation is supported by the positive topline results from the Company's Phase 2 study of CYB003 in MDD, which demonstrated an improvement in depression symptoms superior to approved antidepressants and recently reported data with other psychedelics. Positive Four-Month Efficacy Data for CYB003: Robust and sustained improvements in symptoms of depression with two doses of 12 mg or 16 mg of CYB003: Mean reduction from baseline in the MADRS total score was approximately 22 points from baseline in both dosing cohorts. Approximately 75% of the patients were responders (>/= 50% improvement in MADRS scores) following two doses of 16mg.

60% of patients on 12 mg and 75% on 16 mg were in remission from depression following 2 doses (MADRS score

No incidents of suicidal ideation or behavior. No discontinuations due to adverse events. The MADRS is a 10-item, clinician-administered scale designed to measure overall severity of depressive symptoms in subjects with MDD.

It is widely used in clinical trials and accepted by regulatory authorities worldwide as a measure of symptoms of depression. The MADRS includes items ranging from sadness of mood, reduction in sleep and appetite, to difficulties in concentration, anhedonia, and negative and suicidal thoughts that are scored from 0 to 6, giving a total score ranging from 0 to 60. Typical score ranges for severity are: 0-6 normal; 7-19 mild; 20- 34 moderate; and >34 severe depression.

In the CYB003 study, mean baseline total scores on the MADRS were 31.4 to 33.7 in the active group and 30.8 in the placebo group.