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Research from Water Tower Research

Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

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<ul><li>CYB003’s Phase 2 data demonstrate impressive long-term safety and efficacy data.</li><li>Cybin’s release of its highly anticipated 12-month safety and efficacy data for CYB003, its proprietary deuterated psilocin program for the potential adjunctive treatment of major depressive disorder, did not disappoint.</li><li>The outcomes demonstrated durable and robust efficacy from its Phase 2 study of CYB003. </li></ul>

CYB003’s Phase 2 data demonstrate impressive long-term safety and efficacy data.Cybin’s release of its highly anticipated 12-month safety and efficacy data for CYB003, its proprietary deuterated psilocin program for the potential adjunctive treatment of major depressive disorder, did not disappoint.The outcomes demonstrated durable and robust efficacy from its Phase 2 study of CYB003. 

Cybin, Inc. - CYB003 Demonstrates Exceptional Durable Treatment Benefits for Depression

<ul><li>CYB003’s Phase 3 trial begins. In just three years since filing its Investigational New Drug Application (IND) for its adjunctive CYB003 program, now labeled PARADIGMTM (an allusion to CYB003’s potential for a paradigm shift in treating depression), Cybin has initiated the first of three Phase 3 pivotal efficacy studies.</li><li>Pivotal first study is underway, with top-line results expected in 2026.</li><li>The first study (named APPROACH) is a two-arm study involving a targeted 220 participants with moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately.</li></ul>

CYB003’s Phase 3 trial begins. In just three years since filing its Investigational New Drug Application (IND) for its adjunctive CYB003 program, now labeled PARADIGMTM (an allusion to CYB003’s potential for a paradigm shift in treating depression), Cybin has initiated the first of three Phase 3 pivotal efficacy studies.Pivotal first study is underway, with top-line results expected in 2026.The first study (named APPROACH) is a two-arm study involving a targeted 220 participants with moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately.

Cybin, Inc - CYB003 Phase 3 Trial Initiated

<ul><li>Compass pushes back timeline for COMP360 Phase 3 readouts and cuts staff by 30%.</li><li>Compass Pathways’ (NASDAQ: CMPS) 3Q24 earnings announcement last week was dominated by the news that, not for the first time, the company has pushed back the timeline for the readout of its first single-dose study (COMP005) of the Phase 3 trial for its lead psilocybin-based drug candidate for treatment-resistant depression (TRD), COMP360, by a couple of quarters to 2Q25 from 4Q24.</li><li>The readout for the second two-dose study (COMP006) has been delayed by at least one year from mid-2025 to 2H26. </li></ul>

Compass pushes back timeline for COMP360 Phase 3 readouts and cuts staff by 30%.Compass Pathways’ (NASDAQ: CMPS) 3Q24 earnings announcement last week was dominated by the news that, not for the first time, the company has pushed back the timeline for the readout of its first single-dose study (COMP005) of the Phase 3 trial for its lead psilocybin-based drug candidate for treatment-resistant depression (TRD), COMP360, by a couple of quarters to 2Q25 from 4Q24.The readout for the second two-dose study (COMP006) has been delayed by at least one year from mid-2025 to 2H26. 

Cybin, Inc. - Why Compass Pathways Is No Compass for Cybin's Progression Prospects

<ul><li>Impressive CYB003. Drysdale believes that what has been seen in its Phase 2 work on the development of this modified version of psilocin, the active agent in psilocybin, may have yielded the most impressive data in depression yet from a clinical study.</li><li>Thus, Cybin is approaching with excitement the more rigorous Phase 3 trial, which will involve a total pool of 550 patients with moderate to severe major depression disorder.</li><li>The trial is expected to start in the next few weeks.</li></ul>

Impressive CYB003. Drysdale believes that what has been seen in its Phase 2 work on the development of this modified version of psilocin, the active agent in psilocybin, may have yielded the most impressive data in depression yet from a clinical study.Thus, Cybin is approaching with excitement the more rigorous Phase 3 trial, which will involve a total pool of 550 patients with moderate to severe major depression disorder.The trial is expected to start in the next few weeks.

Cybin, Inc. - Potential of a Significant Paradigm Shift

Thematic (Sector/Industry)

<ul><li>For psychedelics, 2024 could be defined by the disappointing outcome of the FDA’s August review decision on Lykos Therapeutics’ (formerly MAPS) NDA for its MDMA-AT candidate for PTSD.</li><li>The FDA’s decision flew in the face of the anticipatory excitement following the NDA submission and award of breakthrough therapy designation earlier in the year following impressive results from Lykos’ two- part Phase 3 trial.</li><li>However, as disappointing as it is, particularly for the many millions of PTSD sufferers and Lykos, which subsequently reduced its workforce by 75%, in the grand scheme of things, this is only a temporary setback.</li></ul>

For psychedelics, 2024 could be defined by the disappointing outcome of the FDA’s August review decision on Lykos Therapeutics’ (formerly MAPS) NDA for its MDMA-AT candidate for PTSD.The FDA’s decision flew in the face of the anticipatory excitement following the NDA submission and award of breakthrough therapy designation earlier in the year following impressive results from Lykos’ two- part Phase 3 trial.However, as disappointing as it is, particularly for the many millions of PTSD sufferers and Lykos, which subsequently reduced its workforce by 75%, in the grand scheme of things, this is only a temporary setback.

Shroom Shmooz Psychedelics: Trends to Watch Going into 2025

Canada

Cybin Inc. is a life sciences company. The Company focuses on psychedelic drug development, unique delivery mechanisms, improved novel compounds, and protocols. Cybin serves customers worldwide.

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Cybin (CYBN CN)

Cybin, Inc. - CYB003 Demonstrates Exceptional Durable Treatment Benefits for Depression

CYB003 also demonstrated an excellent safety profile, with no new adverse events reported in the 12- month follow-up, including no reports of...

Water Tower Research

Cybin, Inc - CYB003 Phase 3 Trial Initiated

Pivotal first study is underway, with top-line results expected in 2026. The first study (named APPROACH) is a two-arm study involving a targeted...

Water Tower Research

Cybin, Inc. - Why Compass Pathways Is No Compass for Cybin's Progression Prospects

To conserve cash to fund its COMP360 program, Compass also announced a corporate restructuring involving the downsizing of staff by ~30% as well as...

Water Tower Research

Cybin, Inc. - Potential of a Significant Paradigm Shift

Such an outcome could be a paradigm shift for the 68 million people in the US suffering from anxiety disorders (of which GAD is the most prevalent)

Water Tower Research

Shroom Shmooz Psychedelics: Trends to Watch Going into 2025

For psychedelics, 2024 could be defined by the disappointing outcome of the FDA’s August review decision on Lykos Therapeutics’ (formerly MAPS) NDA...

Water Tower Research

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