Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.
Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.
Major Depressive Disorder (MDD) is a pervasive mental health disorder that continues to cast a shadow over the lives of millions worldwide. This debilitating condition, characterized by persistent feelings of sadness, hopelessness, and a loss of interest in daily activities, poses a complex web of challenges for both patients and clinicians. Treating MDD has proven to be extremely difficult due to its multifaceted nature: a combination of genetic predisopsition and traumatic life circumstances. The condition's heterogeneity, marked by varying symptom profiles among individuals, necessitates a nuanced approach to treatment. Moreover, the intricate interplay of genetic, environmental, and neurobiological factors contributing to MDD underscores the need for a diverse arsenal of therapeutic options.
In this bleak landscape, a ray of hope emerges in the form of CYB003, Cybin's innovative deuterated psilocybin analog. Recent Phase 2 trial results for CYB003 have brought promising results to the forefront, demonstrating a significant -14 point difference (p=0.0005) in Montgomery-Asberg Depression Rating Scale ("MADRS") scores between CYB003 (12mg) and placebo at 3 weeks, and an impressive jump in remission rates to 79% after two doses at 6 weeks. These findings signify a potential breakthrough in MDD treatment, offering new possibilities for individuals burdened by the weight of depression.
Furthermore, CYB003 demonstrates a favorable safety and tolerability profile with no treatment-related serious adverse events at 12mg and 16mg doses. The stage is now set for Cybin to submit topline data to the FDA and request an end of Phase 2 meeting, with this FDA meeting expected to be held in Q1 2024.
Additional 12-week durability data from the Phase 2 CYB003 study is anticipated in Q1 2024. In addition, recruiting for a CYB003 Phase 3 study is anticipated to begin by the end of Q1 2024.
CYBN shares have been in a correction since the first release of phase 2 topline data for CYB003 at the end of October. A fresh US$30 million financing at $.45 has also helped to pin the CYBN share price in an oscillation around the $.45 level:
The company has a strong cash position with more than C$40 million expected to be in the company treasury at YE 2023.
Additional clinical trial readouts from CYBN’s phase 1 trials for CYB004 and SPL028 are expected by year end. In addition, the FDA greenlighting CYB003 to phase 3 in major depressive disorder has the potential to deliver a substantial rerating for CYBN shares in the eyes of investors.
At MedicalGold, we believe the investment opportunity in the medical psychedelics space has never been greater than it is today; valuations have rarely been lower, we have never had more compelling clinical data than we do today, and we are entering catalyst rich 2024. We used yesterday's sell-off on positive news to add to our CYBN position at $.45 per share.
Author owns shares of Cybin Inc. at the time of publishing and may choose to buy or sell at any time without notice.
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