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.