Cybin Inc. - CYBN STOCK NEWS

Cybin has received FDA clearance to proceed with its Phase 1/2a clinical trial for CYB003, a novel psilocybin analog aimed at treating major depressive disorder. This milestone marks the first clinical development of a psilocybin analog. Patient recruitment will start immediately, with interim pharmacokinetic and safety data expected in Q4 2022. The trial will evaluate the impact of CYB003 on patients currently using antidepressants, assessing outcomes at two intervals post-administration. The compound demonstrated promising preclinical results indicating reduced dosing variability and improved effectiveness.

Cybin Inc. has reported its audited financial results for the fiscal year ended March 31, 2022, along with strategic milestones for 2022. The company has received IRB approval for its Phase 1/2a trial of CYB003 in major depressive disorder, expected to start mid-2022. Cybin plans to accelerate clinical development of CYB004 for anxiety disorders and has strengthened its IP portfolio with new patents. Financially, cash and cash equivalents stand at C$53.6 million, with a net loss of C$67.6 million for the fiscal year.

Cybin Inc. has received Institutional Review Board approval to start a first-in-human Phase 1/2a clinical trial evaluating its deuterated psilocybin analog, CYB003, for treating major depressive disorder (MDD). This milestone supports the company's goal to provide effective treatment options. The trial design includes double-blind, placebo-controlled methods, with assessments at Week 3 and Week 6 for efficacy. CYB003 aims to achieve faster onset and better tolerability compared to traditional psilocybin treatments.

Cybin has announced the acquisition of the largest Phase 1 DMT study in history from Entheon Biomedical Corp. This study aims to expedite the development of CYB004, Cybin's proprietary DMT molecule for anxiety treatment, by approximately nine months. Conducted in the Netherlands with 50 volunteers, this study will provide critical data on safety and dosing. The acquisition is valued at $1,000,000 CAD, with a potential additional $480,000 CAD for consulting services. The deal is expected to close within 30 days pending approval.

Cybin Inc. has announced that its subsidiary, Adelia Therapeutics, achieved significant milestones as outlined in a December 2020 agreement. This includes a payment of $2,033,309.79 to Adelia shareholders, tied to milestone achievements. Class B shares will be issued, exchangeable for Cybin common shares at a rate of 10 to 1. The process for exchange is scheduled over the next two years. Cybin continues its mission to develop safe therapeutics to address mental health issues, leveraging innovative drug discovery and delivery systems.

Cybin has launched the EMBARK Psychedelic Facilitator Training Program, led by a team of 28 experts, aiming to enhance the training of psychedelic-assisted psychotherapy facilitators. This comprehensive program emphasizes ethical education and prepares facilitators to handle diverse participant experiences through six clinical domains and four care cornerstones. The initiative reflects Cybin's commitment to advancing therapeutic practices in the psychedelic field and supporting mental health treatment. The company continues to focus on psychedelic health innovations.

Cybin Inc. has published a peer-reviewed article detailing EMBARK, a model of psychedelic-assisted psychotherapy aimed at improving treatment effectiveness for mental health issues. Published on June 2, 2022, in Frontiers in Psychology, the article outlines EMBARK's six clinical domains: Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, and Keeping Momentum. The model responds to existing gaps in psychedelic therapy, integrating evidence-based practices and ethical considerations. Upcoming clinical trials will utilize EMBARK to support study participants using proprietary psychedelic molecules CYB003 and CYB004.

Cybin Inc. will host a Key Opinion Leader webinar on June 9, 2022, from 11:00 a.m. ET to 12:00 p.m. ET. Featured speakers include renowned experts Dr. John Krystal from Yale School of Medicine and Dr. David Nutt from Imperial College London, who will discuss the evolving psychedelics landscape and emerging therapeutic options. The event, moderated by Doug Drysdale, Cybin's CEO, aims to shed light on the potential of psychedelic-based treatments for mental health disorders. Registration is available on Cybin's website.

Cybin has submitted an Investigational New Drug (IND) application to the FDA for its CYB003, a deuterated psilocybin analog, aiming to treat major depressive disorder (MDD). This milestone follows successful IND-enabling work, with expectations to initiate Phase 1/2a clinical trials in mid-2022. The trial is a randomized, double-blind, placebo-controlled study that will assess the rapid onset of antidepressant effects and safety. Preliminary pharmacokinetic and safety data are expected by year-end 2022.