NeonMind Biosciences

Overview

Psychedelics have taken center stage as an emerging treatment for mental health and behavioral disorders. Major research institutes such as John Hopkins and biotechnology companies have generated promising clinical data on the efficacy and safety of treatments using psychedelics, with the focus towards receiving regulatory approval and commercialization as medical treatments. These transformational treatments are both significant and welcome medical innovations given the growing mental health epidemic and addiction crisis which current treatments are inadequately addressing.

Of the many psychedelic compounds, psilocybin and MDMA are at the forefront of receiving approval with anticipation that these drugs could be used as treatments in specialized medical clinics in the coming years. Recent human clinical studies using psilocybin have shown efficacy in both traditional psychiatric conditions such as depression and anxiety disorders.

Studies also suggest improvement in behavioral and addictive conditions such as eating disorders, smoking cessation, and drug use disorders. Research has enabled clinicians to hone in on how best to administer these treatments. The widespread efficacy in multiple disorders is a sign of a potential transformational medical treatment.

Currently, patients can only access newer psychedelic treatments, such as psilocybin, through clinical studies and special access programs until these treatments receive regulatory approval. Mental health treatment options with approved drugs classified as psychedelics, such as ketamine and esketamine, can already be accessed in specialized medical clinics because they are approved by regulators and have been included in medical guidelines.

A promising development is the development of a new treatment using the existing drug ketamine, has been developed for mood and anxiety disorders, showing strong efficacy and safety, and receiving recommendation in the Canadian guidelines.

NeonMind Biosciences (CSE:NEON,OTCQB:NMDBF,FRA:6UF) is a drug development and healthcare company pioneering innovative ways to bring transformational mental health treatments to market with a focus on psychedelics. The company aims to improve access to psychedelic treatments with two strategies:

1. Establishing specialized mental health clinics that provide currently available treatments such as ketamine and esketamine and to provide other psychedelic treatments when approved.
2. Focusing on drug development of novel psychedelic treatments focusing on their proprietary drug candidates to treat behavioral deficits in patients with weight management issues and obesity.

Regarding its specialty mental health clinics, NeonMind will begin rolling out mental health treatments to select cities in the first half of 2022 and expand to more locations in 2023. Its first treatment, which was recently announced, will be to provide ketamine for the medical treatment of mood and anxiety disorders as recommended by the Canadian guidelines.

NeonMind has partnered up with two leading specialty medical treatment companies, SRx Health and BioScript Solutions, which together operate over 100 clinic locations throughout Canada. NeonMind’s inaugural location has already been announced in Mississauga, Ontario.

NeonMind’s clinics will address a major gap in the Canadian market, namely access to innovative and validated mental health treatments with its first treatment focusing on ketamine. This strategy not only provides immediate cash flow but it also establishes a business that can be leveraged to provide new psychedelic treatments as they receive approval.

The company's other division, focused on development of psychedelic drug candidates, is preparing to initiate a first-in-class clinical study to treat weight management and obesity. The company has developed two drug programs, one of which utilizes a high dose of psilocybin, while the other uses a lower dose. The company has already engaged regulators for its planned clinical trials and has received positive feedback from the US Food and Drug Administration (FDA) after its pre-Investigational New Drug (pre-IND) consultation.

During our interview, CEO Robert Tessarolo said, “Preclinical work led us down the path of the obesity indication. We have a clear plan for commercialization to move our asset through to a new drug application with the FDA because we visited them in the fourth quarter of last year, and we conducted a pre-IND consultation meeting. We shared with the FDA our research plans, our designs, and we received their feedback which was positive. With their feedback, it established a clear pathway to advancing our program, performing clinical studies, and then submitting our drug candidate for regulatory review.”

Company Highlights

• NeonMind has a strategy in the psychedelic sector with a dual focus on creating specialty mental health clinics and pioneering psychedelic drug development to advance psilocybin for chronic weight management disorders.
• It’s the first and only company developing novel psilocybin-based treatments to address the US$326 billion by 2028 global weight management market, representing a vast, untapped therapeutic area for psychedelics.
• Working with strategic partners, the NeonMind is building out a nationwide network of NeonMind-branded specialty mental health clinics in Canada, incorporating evidence-based interventional treatments to address a variety of mental health needs.
• NeonMind partnered with two leading specialty medical companies, SRx Health and BioScript Solutions, which together operate over 100 clinic locations throughout Canada, allowing NeonMind to announce its inaugural location in Mississauga, Ontario.
• The company is led by an experienced management team with experience in biotech and healthcare and leading scientific and medical advisors in the field of psychedelics and psychiatry.

Key Projects

Specialty Treatment Clinics

NeonMind will create a network of specialty clinic treatment centers that can legally administer treatments with approved drugs classified as psychedelics including ketamine and esketamine. It has established partnerships with leading specialty medical treatment companies SRx Health and BioScript Solutions to roll out these revolutionary treatments. This initiative represents the company’s short-term strategy to start generating revenue.

Project Highlights:

• Targeting High-Impact Treatment Offerings: NeonMind has selected treatments and locations with strong demand but with a supply gap due to lack of availability to treatment locations. NeonMind will enter these markets and have an immediate impact on treatment availability for these patients.
• Scalable and Efficient Model: NeonMind has built its operating model to be scalable and efficiently deployed with its partners which have access to over 100 clinics throughout Canada.
• Rapid Rollout In Anticipation of New Treatments: Following the inaugural clinic, three additional clinics will be announced in 2023, with an additional six clinics in 2024. Growing market adoption, driven by treatment availability and clinical evidence, is expected. Additionally, new psychedelic treatments will be offered at these clinics, once approved.

Drug Development (NEO-001 and NEO-002)

Two drug candidates are currently being developed that utilize psilocybin in different doses. NEO-001 uses a high dose of psilocybin to complement psychotherapy sessions, with a view to induce lasting lifestyle changes. NEO-002 has a low dose of psilocybin and will be prescribed for continued appetite suppression.

Project Highlights:

• Multiple Drug Programs: The high-dose treatment intentionally induces a hallucinogenic effect to catalyze lasting changes, while the low-dose treatment will induce satiety without the hallucinogenic effect.
• NEO-001 Has a Clear Clinical Pathway: FDA guidance has already been provided for the high dose drug candidate and NeonMind is preparing to initiate a first-in-class clinical study to treat weight management and obesity
• A Growing Body of Evidence: NeonMind and other researchers continue to discover the positive effects of psilocybin as it relates to weight management. Recent animal studies show a 30 percent reduction in weight gain versus placebo with positive effects seen as early as three days of administration.

Management Team

Robert Tessarolo - President & Chief Executive Officer

Robert Tessarolo has over 25 years of experience in the pharmaceutical industry. Former president, CEO and director of Mind Medicine (NEO:MMED). Mind Medicine was the first psychedelics company to list on a stock exchange. Former president and CEO of Cipher Pharmaceuticals (TSX:CPH), Tessarolo expanded the product pipeline with seven business development transactions that restored the company to positive earnings before interest, taxes, depreciation and amortization (EBITDA). He served as president of Watson Pharmaceuticals Canada and led the integration of major mergers and acquisitions. These included Warner Chilcott, an approximately US$5 billion global acquisition, Forest Laboratories an approximately US$28 billion global acquisition and Allergan an approximately US$66 billion global acquisition.

Rick Huang - Chief Financial Officer

Rick Huang is the former CFO of Better Plant Sciences (CSE:PLNT) and has served as chair of the audit committee for Datable Technology (TSXV:TTM) since 2015. Huang is the former CFO of Hanwei Energy Services (TSX:HE) and previously served as chair of governance and member of audit committees at Poydras Gaming Finance (TSXV:PYD). He is a Certified General Accountant and a designated Chartered Professional Accountant in Canada.

Ernie Ho, PhD - Vice President of Corporate Development

Ernie Ho earned his doctoral degree from Western University and brings over 15 years of development and commercialization experience in leading Canadian biopharmaceutical and diagnostic companies from preclinical development to product management. He developed and successfully launched innovative medical services at Canada’s largest diagnostic provider, LifeLabs, focused on client needs and improved patient outcomes. Ernie has significant career success in corporate development, including pivotal roles in licensing, mergers and acquisitions, and capital raises at Therapure Biopharma, now Resilience Biotechnologies, and Cipher Pharmaceuticals (TSX:CPH).

Dr. Sagar Parikh, MD - Member of the Specialty Clinics Advisory Board

Dr. Sagar Parikh is a Professor of Depression and Clinical Neuroscience and Professor of Psychiatry at the University of Michigan. Dr. Parikh is the medical director at the National Network of Depression Centers. He is the author and editor of three books and over 200 peer reviewed articles and book chapters. Dr. Parikh co-authored the Canadian Network for Mood and Anxiety Treatments (CANMAT) treatment guidelines for depression and for bipolar disorder, the world's most cited mood disorder guidelines.

Dr. Roumen Milev, MD, PhD - Member of the Specialty Clinics Advisory Board

Dr. Roumen Milev is the clinical lead of Providence Care Hospital Interventional Psychiatry. He oversaw more than 1,000 patients successfully treated with ketamine and neurostimulation modalities. Dr. Milev is the executive chair elect of the CANMAT and an executive committee member of the Canadian Biomarker Integration Network for Depression (CAN-BIND). He authored and edited over 140 peer-reviewed articles and book chapters. Dr. Milev also co-authored the CANMAT treatment guides.

Dr. Gustavo Vazquez, MD, PhD - Member of the Specialty Clinics Advisory Board

Dr. Gustavo Vazquez is a Professor of Psychiatry at Queen’s University and the clinical lead of Providence Care’s ketamine clinic, treating more than 100 patients with ketamine. Dr. Vazquez is an active research member of the International Consortium for Psychotic and Bipolar Disorders Research, McLean Hospital and Harvard Medical School. He is also a fellow and active member of the Royal College of Physicians of Canada. Dr. Vazquez authored and edited over 130 peer-reviewed articles and book chapters, in addition to two books, including, “Ketamine for Treatment-Resistant Depression: Neurobiology and Applications”.

Dr. Daniel Bainbridge, MD - Member of the Specialty Clinics Advisory Board

Dr. Daniel Bainbridge is the former president of the Canadian Anesthesiologists Society and a member of the Royal College of Physicians of Canada. He worked as a professor in the Department of Anesthesia and Perioperative Medicine at the University of Western Ontario. Dr. Bainbridge was an anesthesia consultant at London Health Sciences Centre, serving on its Specialty Clinics Advisory Board. Dr. Bainbridge has 20 years of experience in practice and leadership in the field of anesthesiology.

Philippe Martin - Chair of the Research & Development Advisory Board

Philipe Martin has 20 years of biotechnology and pharmaceutical industry experience developing and commercializing innovative therapies in the fields of immunology, oncology and neurology. Chief of clinical development and operations at BioAtla, Martin oversaw the development of pre-clinical and clinical assets. Previously, at Celgene, he led the Otezla® team, before which he led the remicade versus simponi iodine lifecycle strategy at Schering-Plough.

Dr. Albert Garcia-Romeu, PhD - Member of the Research & Development Advisory Board

Dr. Albert Garcia-Romeau is an Assistant Professor of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. He has conducted more than 90 high-dose psilocybin sessions in the laboratory since 2012. Dr. Garcia-Romeu is a founding member of the Johns Hopkins Center for Psychedelic and Consciousness Research.