Cybin completes enrollment in phase 2 DMT anxiety study

TORONTO - Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage biotech company with a market capitalization of $152.45 million and currently trading at $6.42, has completed enrollment of 36 participants in its Phase 2 study of CYB004, a deuterated dimethyltryptamine (DMT) program for Generalized Anxiety Disorder (GAD), according to a company press release. Topline data from this study is expected in the first quarter of 2026. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics.

The clinical-stage neuropsychiatry company is simultaneously advancing CYB003, its proprietary deuterated psilocin analog, in Phase 3 studies for major depressive disorder (MDD). The first pivotal study, called APPROACH, is currently dosing patients and aims to enroll 220 participants across 45 U.S. clinical sites. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 9.87, though it’s currently experiencing rapid cash burn - one of several key insights available to Pro subscribers.

A second Phase 3 study called EMBRACE is expected to begin in the fourth quarter of 2025, targeting 330 participants with moderate to severe MDD. This study has received approval to initiate in Australia, Ireland, Poland, Greece, and the United Kingdom.

The company reports that its CYB003 program has shown promising durability in Phase 2, with 100% response rates and 71% remission rates maintained at 12 months following two 16mg doses. The program has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.

Cybin has partnered with Thermo Fisher Scientific for U.S.-based commercial-scale manufacturing capabilities for the CYB003 program, establishing two dedicated facilities for Phase 3 clinical supply and potential future commercialization.

The company has built what it describes as a sector-leading intellectual property portfolio with over 100 granted patents and 250+ pending applications, which it claims provides exclusivity until 2041.

"We have established a leading position in the psychedelic therapeutics space through Cybin’s proprietary drug discovery platforms that combine novel deuterated molecules with innovative drug delivery systems," said Eric So, Interim Chief Executive Officer of Cybin, in the press release. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates analysts have recently revised their earnings expectations downward for the upcoming period. Discover more detailed financial insights and 8 additional ProTips by subscribing to InvestingPro.

In other recent news, Cybin Inc. has completed enrollment for its Phase 2 clinical trial of CYB004, aimed at treating Generalized Anxiety Disorder. The trial involves 36 participants and assesses the safety and efficacy of CYB004 over 12 weeks. Additionally, Cybin has received European approval to initiate the EMBRACE study, a Phase 3 trial for its drug CYB003 targeting Major Depressive Disorder, following UK regulatory approval. This study will take place across multiple countries, including Ireland, Poland, and Greece, and aims to enroll 330 participants.

In terms of analyst activity, H.C. Wainwright reiterated its Buy rating for Cybin, maintaining a $150 price target, citing the completion of the CYB004 Phase 2 trial enrollment as a key catalyst. Meanwhile, Canaccord Genuity adjusted its price target for Cybin to $70 from $73 but maintained a Buy rating, reflecting updates in its financial model. The firm projects a 40% probability of approval for CYB003 with potential sales reaching C$4.0 billion by fiscal 2036. These developments reflect ongoing progress and interest in Cybin’s clinical programs.

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