This article looks at what neurological diseases Cybin Inc. (CYBN) is focused on, its clinical trial progress to date, its latest quarterly financials, the history of its stock price performance, and the price forecasts for the stock over the next 12 months.
An original article by Lorimer Wilson, Managing Editor of munKNEE.com
About Cybin Inc.
Cybin Inc. (CYBN) is focused on progressing “Psychedelics to Therapeutics” by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches, and treatment regimens for mental health disorders.
Treatments prescribed for mental health conditions have not changed in 30+ years and, for its part, Cybin is on a mission to leverage the decades of research to develop transformative psychedelic-based therapeutics to improve patients’ mental health conditions and clinical outcomes.
Research and Development Pipeline
Cybin (see here) has 2 programs in Phase 1 development:
- CYB003: Deuterated Psilocybin
- CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD).
- Interim findings from the completed Phase 1 portion of the trial demonstrated positive observations, including a rapid and short-acting psychedelic response in participants and all doses were well-tolerated with no serious adverse events reported.
- The Phase 2a portion of the trial has commenced and expects to report top-line results from the completed Phase 1/2a clinical trial in Q3, 2023. Doug Drysdale, Chief Executive Officer of Cybin said in a news release that:
- “It is incredibly gratifying that our findings from the interim readout of the CYB003 Phase 1/2a clinical trial align with the results observed in preclinical studies. Robust psychedelic effects were observed at low doses, absorption was rapid with low variability, and effects were short lasting – all desired outcomes. These findings give us confidence in the potential efficacy of the underlying active agent, which may ultimately reduce symptoms of depression after just one or two doses. This would be a remarkable improvement over chronic treatments that are available today. We are encouraged by the progress made in advancing our CYB003 molecule and look forward to continuing the momentum to advance this program through clinical development to bring this important treatment option to people who suffer from depression as quickly as possible.”
- CYB004: Deuterated Dimethyltryptamine (DMT)
- CYB004 has the potential to effectively treat Generalized Anxiety Disorder with or without major depressive disorder and the potential for more convenient and less invasive delivery methods via inhaled, subcutaneous, or intra-muscular routes of administration.
- The Phase 1 CYB004-E trial, evaluating 50 healthy volunteers, is the largest ever Phase 1 DMT trial conducted to-date and marks the first time a deuterated DMT molecule will be evaluated in humans. Doug Drysdale, Cybin’s Chief Executive Officer said in a news release that:
- “The ability to evaluate our novel CYB004 molecule in humans at this early stage is a significant achievement in clinical development and will provide important insight into the pharmacokinetic and pharmacodynamic properties of CYB004 in addition to what we have already learned through our study of DMT. We expect to apply these findings to optimize dosing and delivery of CYB004 in future clinical trials, which supports our mission to bring this new investigational therapy to patients as quickly as possible.
- With strong intellectual property in place and promising preclinical data, we believe we have a solid clinical development path forward for CYB004. We will continue to focus our research on identifying the most convenient routes of administration while also maintaining an optimal therapeutic profile for this important molecule.
- …We see the potential for short duration treatments, which could truly transform the treatment paradigm and outcomes for patients. As well, we believe that deuteration may support less invasive and more convenient dosing methods for providers and patients.”
- In addition, CYB005, a discovery-phase phenethylamine derivative is in pre-clinical development with the potential to effectively treat neuroinflammation and psychiatric conditions.
Q3 Financial Highlights
- All numbers for the period ending December 31st, 2022, are reported in Canadian dollars and are compared to the previous quarter. Go here to convert into other currencies. Go here for more in-depth and historical financial numbers.
- Revenue: NIL
- SG&A: -2.4% to $12.0M
- R&D: +23.5% to $6.3M
- Net Income (Loss): +7% to $(10.7)M
- Cash on Hand: -25.5% to $22.5M
- As per its previously announced at-the-market equity program, Cybin is allowed to issue and sell up to an additional US$26 (C$35) million of common shares which will provide Cybin with access to additional cash for growth opportunities and working capital.
Stock Price Performance
Cybin’s stock price declined 70% in 2022 in line with the 70% decline experienced by the other 5 major clinical-stage psychedelic stocks in the munKNEE Psychedelic Drug Stocks Index but it is already up 59% YTD.
- The 6 firms following Cybin (EF Hutton, Cantor Fitzgerald; H.C. Wainwright & Co., Canaccord Genuity, Stifel, and Oppenheimer) forecast that the stock will jump by 1392%, on average, to $5.82 in the next 12 months which represents a 14-fold return and is included in munKNEE’s “Rags-to-Riches” Portfolio.