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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>3QFY25 earnings release. The most important pieces of information from the earnings release of a late clinical-stage biotech company like Cybin (NYSE: CYBN) are principally updates on upcoming clinical milestones and the state of its balance sheet.</li><li>On this basis, we highlight the key takeaways from Cybin’s 3QFY25 earnings report that was released this week.</li><li>Milestones update. The release hinted at slight timeline slippages in upcoming milestones, which can be considered the normal course of business in the clinical research world.</li></ul>

3QFY25 earnings release. The most important pieces of information from the earnings release of a late clinical-stage biotech company like Cybin (NYSE: CYBN) are principally updates on upcoming clinical milestones and the state of its balance sheet.On this basis, we highlight the key takeaways from Cybin’s 3QFY25 earnings report that was released this week.Milestones update. The release hinted at slight timeline slippages in upcoming milestones, which can be considered the normal course of business in the clinical research world.

<ul><li>GH Research’s (NASDAQ: GHRS) release earlier this week of the top-line read of the Phase 2b trial of its lead fast onset and short-acting 5-MeO-DMT monotherapy candidate GH-001 in treating treatment-resistant depression (TRD) elicited an unequivocally positive reaction from investors.</li><li>GHRS’ share price surged 70% on the day of the release and opportunistically opened up a pathway to the commencement of a public offering at $15/share (41.5% above the GHRS level immediately prior to the GH-001 Phase 2b results release).</li><li>GH-001 met its end points in its short eight-day double-blind placebo-controlled study with an eight-day 15.2 placebo-adjusted reduction in MADRS from the baseline and a remission rate of 57.5%. </li></ul>

GH Research’s (NASDAQ: GHRS) release earlier this week of the top-line read of the Phase 2b trial of its lead fast onset and short-acting 5-MeO-DMT monotherapy candidate GH-001 in treating treatment-resistant depression (TRD) elicited an unequivocally positive reaction from investors.GHRS’ share price surged 70% on the day of the release and opportunistically opened up a pathway to the commencement of a public offering at $15/share (41.5% above the GHRS level immediately prior to the GH-001 Phase 2b results release).GH-001 met its end points in its short eight-day double-blind placebo-controlled study with an eight-day 15.2 placebo-adjusted reduction in MADRS from the baseline and a remission rate of 57.5%. 

Cybin, Inc. - Why CYB003 Deserves More Attention

<ul><li>Addressing skeptics of CYB003’s durability data. As impressive as CYB003’s Phase 2 12-month data are, not everyone fully embraces them because of the small population size (n=7) from which they were generated.</li><li>While this may logically be a fair question, Inamdar addressed this question by stating that not all data are created equal, with some data more impactful than others.</li><li>Even with small numbers, you can have highly impactful data, and CYB003’s data were highly impactful clinically with a 100% response rate, a 70%-plus remission rate, and a mean 23-point MADRS change from baseline versus the two to three-point change that is typically considered by experts to be clinically significant outcomes for depression.</li></ul>

Addressing skeptics of CYB003’s durability data. As impressive as CYB003’s Phase 2 12-month data are, not everyone fully embraces them because of the small population size (n=7) from which they were generated.While this may logically be a fair question, Inamdar addressed this question by stating that not all data are created equal, with some data more impactful than others.Even with small numbers, you can have highly impactful data, and CYB003’s data were highly impactful clinically with a 100% response rate, a 70%-plus remission rate, and a mean 23-point MADRS change from baseline versus the two to three-point change that is typically considered by experts to be clinically significant outcomes for depression.

Cybin, Inc. - First Dosing of Meticulously Planned CYB003 Phase 3 Program Imminent

<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

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.: A Cash Flow Analysis

Milestones update. The release hinted at slight timeline slippages in upcoming milestones, which can be considered the normal course of business in...

Water Tower Research

Cybin, Inc. - Why CYB003 Deserves More Attention

GHRS’ share price surged 70% on the day of the release and opportunistically opened up a pathway to the commencement of a public offering at $15/share

Water Tower Research

Cybin, Inc. - First Dosing of Meticulously Planned CYB003 Phase 3 Program Imminent

As impressive as CYB003’s Phase 2 12-month data are, not everyone fully embraces them because of the small population size (n=7) from which they...

Water Tower Research

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

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