Cybin Inc. (NEO: CYBN) (NYSE American: CYBN)

Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) is a clinical-stage biopharmaceutical company focused on progressing psychedelics to therapeutics, offering a new standard of care for mental health disorders and improving patient outcomes. The company is led by a team of leading scientific and industry experts with deep roots in biotech, psychedelics, and mental health, to translate top-tier science into potential best-in-class therapeutics.

Cybin takes a holistic approach to psychedelic therapeutics that encompasses three pillars: drug discovery, drug delivery, and innovative treatment. This 'bench to bedside' approach enables Cybin to translate novel research into potential treatments for multiple mental health conditions, including depression, anxiety, and psychiatric disorders.

Key Facts

• Led by CEO Doug Drysdale
  • 30 years of experience in the healthcare sector
  • Chaired the board of directors of a NASDAQ-listed company and, as a CEO for the past 13 years, has built and turned-around four pharmaceutical companies
  • Completed 15 corporate acquisitions across three continents and has raised $4 billion of both public and private capital
  • Former Head of M&A at Actavis Group (Actavis was sold to Watson Pharmaceuticals in 2012 for €4.25 billion)

• Experienced scientific team
  • The only scientific team in the industry that has successfully developed a commercial psychedelic drug
  • Facilitated billions in pharmaceutical sales
  • Successfully helped develop widely used drugs such as Allegra, Sabril, Anzemet & Vaniqa
  • 300+ combined peer-reviewed publications by scientific leadership include work in addiction and psychedelics
  • Collectively involved in 37 exits across the biotech sector and various other verticals
  • Overseen 60+ IND programs with FDA
  • Team pedigree: Merck, Pfizer, Roche, Elan, GSK, Sanofi, and Lilly

Cybin has a strong competitive advantage in the industry with 50 different proprietary psychedelic molecules and growing. The company's IP portfolio, technology rights, and provisional patents include:

1. A USPTO-granted patent covering deuterated forms of DMT and 5-MeO-DMT and protecting the CYB004 substance as a putative new chemical entity
2. A provisional patent application filed for an oral film delivery mechanism
3. A provisional patent application filed for nebulization technology
4. A patent for deuterated DMT and multiple patent applications filed for other deuterated psychedelic molecules and analogs
5. A discovery pipeline of tryptamines and phenylethylamines alongside certain metabolites

Cybin X Kernel

On January 11, 2021, Cybin announced its entry into an agreement with neurotech pioneer HI LLC (dba Kernel) to leverage Kernel's innovative Flow® technology for Cybin-sponsored clinical development.

Kernel Flow is a full-head coverage, time-domain functional near-infrared spectroscopy system designed to detect hemodynamic changes in the brain. The platform pulses light through the skull and into the bloodstream in order to measure how much oxygen the blood is carrying at any given time. Kernel Flow is expected to facilitate further and more detailed research into psychedelic therapeutic offerings for those suffering from mental health disorders.

By partnering with Kernel, Cybin may have the potential to:

• Quantify brain activity in real-time during psychedelic experiences. The absence of this data has been a limitation in the progression of new molecules targeting neurological disorders.
• Open a new frontier in psychedelic therapeutics by acquiring longitudinal brain activity before, during, and after a psychedelic experience, enabling quantification of what was previously subjective self-reporting.
• Leverage time-domain functional near-infrared spectroscopy, a gold standard optical method for detecting hemodynamics (blood flow) in the cerebral cortex.

Product Offering and Pipeline

Cybin currently has three drug development programs: CYB003, CYB004 & CYB005.

CYB003: Deuterated Psilocybin Analog

• Cybin's lead investigational molecule, CYB003, is derived from psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain barrier. Given its structural similarity to serotonin, psilocybin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect, and potentially better tolerability for an overall better outcome for patients. CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD).
• Current status: Initiated enrollment in Phase 1/2a clinical trial evaluating CYB003 for the potential treatment of major depressive disorder

CYB004: Deuterated Dimethyltryptamine (DMT)

• CYB004 is a deuterated dimethyltryptamine (DMT), which has been shown to exert its psychedelic effects by activating the 5-HT2A receptor. In its natural form, DMT is rapidly metabolized in the body, unstable, and not orally bioavailable. Based on preclinical studies, deuterated DMT has the potential to overcome these limitations and provide increased oral and pulmonary bioavailability, faster onset with lower doses, less patient variability, and better dose titration for fewer side effects and longer-acting desensitization of the serotonergic receptors. CYB004 has the potential to effectively treat anxiety disorders.
• Current status: Conducting Phase 1 DMT clinical trial in 50 healthy volunteers who smoke tobacco

CYB005: Discovery-Phase Phenethylamine Derivative

• CYB005 is a discovery-phase phenethylamine derivative with the potential to effectively treat neuroinflammation and psychiatric conditions.
• Current status: In preclinical development

Market Outlook for Psychedelic Therapies

Cybin's rich IP portfolio could help position the company in a prominent role in the expanding psychedelic therapies market.

More than 900 million people globally suffer from some sort of mental illness, according to the World Health Organization.

Cybin is initially targeting three indications with its active drug programs – major depressive disorder, alcohol use disorder and anxiety.

• The global treatment market for mental health conditions is estimated at $2.5 trillion, including $800 billion in direct economic costs, according to the National Centre for Biotechnology Information.
• In the U.S., the direct and indirect economic costs of mental health conditions are estimated at $467 billion by the National Institute of Mental Health.
• An estimated 17.3 million adults in the United States have had at least one major depressive episode. This number represented 7.1% of all U.S. adults.
• Approximately 5.8 percent or 14.4 million adults in the United States ages 18 and older had AUD in 2018. This includes 9.2 million men and 5.3 million women.
• The U.S. psychedelic drugs market was valued at $2.1 billion in 2019 and is expected to reach nearly $6.9 billion by 2027, accelerating at a CAGR of 16.3 percent, per Data Bridge Market Research.

Management Team

Doug Drysdale is the Chief Executive Officer of Cybin Inc. He is an experienced corporate director and CEO, having chaired the board of directors of a Nasdaq-listed company and led turnarounds at three pharmaceutical companies as CEO. With over 30 years of experience in the health care sector, Mr. Drysdale has formed cohesive management teams, recruited board members, completed 15 acquisitions across three continents, and raised $4 billion in private and public capital. He holds a bachelor's degree in microbial and molecular biology from the University of East Anglia in the United Kingdom and was recognized as the 'Entrepreneur of the Year' by Ernst and Young in 2012.

Eric So is Co-Founder, Executive Chairman, and President of Cybin. He is the Co-Founder and current Managing Director of Trinity Venture Partners Inc., a boutique merchant bank. He is a veteran founder, investor, operator, and advisor to disruptive companies. He began his career practicing in the areas of corporate commercial securities, finance, and mergers & acquisitions at a leading international legal firm. Mr. So has a Bachelor of Science with a major in anatomy and cell biology and a minor in psychology from McGill University. He has a Bachelor of Laws from the University of Windsor.

Paul Glavine is the Co-Founder and Chief Operating Officer of Cybin. He is also the Co-Founder of Global Canna Brands, which was granted the first-ever tier 3 cultivation license in Jamaica. His first cannabis start-up, Truverra, was sold to The Supreme Cannabis Company (TSX: FIRE). He has advised on M&A and other financial transactions totaling over $50 million. He is a serial entrepreneur and investor with vast experience in the biotech and cannabis industries.

Amir Inamdar is the Chief Medical Officer of Cybin. Mr. Inamdar is a qualified psychiatrist and pharmaceutical physician with over 20 years of clinical and drug development experience. He has successfully progressed numerous candidate drugs through preclinical development and early phase clinical trials to proof-of-concept studies. He also has experience in leading global teams overseeing development of novel medications across a range of psychiatric indications, including treatment resistant depression, narcolepsy, anxiety, schizophrenia, bipolar disorder, and substance use disorders.

Aaron Bartlone is the Chief Operating Officer of Cybin. He is the former Chief Quality, Patient Safety, HSE & Risk Officer at UCB Inc., leading a team of 1,500+ colleagues in 54 countries, as well as the former President at UCB Inc., leading U.S. commercial operations through the restructuring into CNS and Immunology business units with annualized 27% P&L growth ($2.2B in revenue). Mr. Bartlone held various director level research, regulatory and managerial roles at Eli Lilly from 1997 to 2006.

Alex Nivorozhkin, Ph.D., is Cybin's Chief Scientific Officer. He is a lead NCE inventor of multiple successfully partnered drug discovery and development programs and a technology developer of proprietary formulations for CNS drugs. Dr. Nivorozhkin is a seasoned medicinal chemist, drug delivery expert, and founder of multiple biotech companies.

Michael Palfreyman, Ph.D., is the company's Chief R&D Officer. He brings three decades of preclinical/clinical development experience to the Cybin team, including time with Scriptgen, EnVivo Pharma, Sanofi, GSK, Amorsa Therapeutics, and others. Dr. Palfreyman has successfully led multiple IND filings and clinical programs, and he boasts a significant portfolio of CNS therapeutics patents and commercial products.

Alex Belser is the company's, Chief Clinical Officer. Mr. Belser is a licensed psychologist, clinical supervisor, and psychedelic researcher at Yale. He has been active in the psychedelic research community for 20 years and has conducted clinical research with psilocybin and MDMA for a variety of indications. Mr. Belser's research has been featured in The New York Times, The Atlantic, The New Yorker, The Guardian, and VICE, as well as in Michael Pollan's book, How to Change Your Mind.