Overview

Psychedelics have taken heart stage as an rising therapy for psychological well being and behavioral problems. Main analysis institutes corresponding to John Hopkins and biotechnology firms have generated promising medical knowledge on the efficacy and security of therapies utilizing psychedelics, with the main focus in direction of receiving regulatory approval and commercialization as medical therapies. These transformational therapies are each important and welcome medical improvements given the rising psychological well being epidemic and dependancy disaster which present therapies are inadequately addressing.

Of the numerous psychedelic compounds, psilocybin and MDMA are on the forefront of receiving approval with anticipation that these medicine could possibly be used as therapies in specialised medical clinics within the coming years. Latest human medical research utilizing psilocybin have proven efficacy in each conventional psychiatric situations corresponding to melancholy and anxiousness problems.

Research additionally recommend enchancment in behavioral and addictive situations corresponding to consuming problems, smoking cessation, and drug use problems. Analysis has enabled clinicians to hone in on how greatest to manage these therapies. The widespread efficacy in a number of problems is an indication of a possible transformational medical therapy.

Additional supporting the potential transformative nature of psychedelic therapies, new research have recognized that psychedelics might have the power to make impactful adjustments to behavioral problems that result in power situations corresponding to weight problems. For instance, analysis has proven that psychedelic compounds might assist assist wholesome weight administration by concentrating on the underlying psychological problems that end in unhealthy consuming habits. Particularly, psilocybin-based therapies might assist sufferers really feel extra satiated and supply an total sense of well-being.

At the moment, sufferers can solely entry newer psychedelic therapies, corresponding to psilocybin, via medical research and particular entry applications till these therapies obtain regulatory approval. Psychological well being therapy choices with authorised medicine categorised as psychedelics, corresponding to ketamine and esketamine, can already be accessed in specialised medical clinics as a result of they’re authorised by regulators and have been included in medical tips.

A promising improvement is the event of a brand new therapy utilizing the prevailing drug ketamine, has been developed for temper and anxiousness problems, displaying sturdy efficacy and security, and receiving advice within the Canadian tips.

NeonMind Biosciences (CSE:NEON,OTCQB:NMDBF,FRA:6UF) is a drug improvement and healthcare firm pioneering progressive methods to carry transformational psychological well being therapies to market with a deal with psychedelics. The corporate goals to enhance entry to psychedelic therapies with two methods:

1. Establishing specialised psychological well being clinics that present presently out there therapies corresponding to ketamine and esketamine and to offer different psychedelic therapies when authorised.
2. Specializing in drug improvement of novel psychedelic therapies specializing in their proprietary drug candidates to deal with behavioral deficits in sufferers with weight administration points and weight problems.

Concerning its specialty psychological well being clinics, NeonMind will start rolling out psychological well being therapies to pick cities within the first half of 2022 and develop to extra areas in 2023. Its first therapy, which was not too long ago introduced, will likely be to offer ketamine for the medical therapy of temper and anxiousness problems as really useful by the Canadian tips.

NeonMind has partnered up with two main specialty medical therapy firms, SRx Well being and BioScript Options, which collectively function over 100 clinic areas all through Canada. NeonMind’s inaugural location has already been introduced in Mississauga, Ontario.

NeonMind’s clinics will deal with a significant hole within the Canadian market, specifically entry to progressive and validated psychological well being therapies with its first therapy specializing in ketamine. This technique not solely gives fast money circulate nevertheless it additionally establishes a enterprise that may be leveraged to offer new psychedelic therapies as they obtain approval.

The corporate’s different division, centered on improvement of psychedelic drug candidates, is getting ready to provoke a first-in-class medical examine to deal with weight administration and weight problems. The corporate has developed two drug applications, one in all which makes use of a excessive dose of psilocybin, whereas the opposite makes use of a decrease dose. The corporate has already engaged regulators for its deliberate medical trials and has obtained constructive suggestions from the US Meals and Drug Administration (FDA) after its pre-Investigational New Drug (pre-IND) session.

Throughout our interview, CEO Robert Tessarolo stated, “Preclinical work led us down the trail of the weight problems indication. We have now a transparent plan for commercialization to maneuver our asset via to a brand new drug software with the FDA as a result of we visited them within the fourth quarter of final 12 months, and we carried out a pre-IND session assembly. We shared with the FDA our analysis plans, our designs, and we obtained their suggestions which was constructive. With their suggestions, it established a transparent pathway to advancing our program, performing medical research, after which submitting our drug candidate for regulatory evaluation.”

Based mostly on the novelty of their analysis, patents for NeonMind’s revolutionary drug candidates are already pending with the US Patent and Trademark Workplace (USPTO) and different worldwide patent workplaces. NeonMind’s long run technique will make the most of the profitable weight administration market, which has a rising market dimension that’s estimated to surpass US$326 billion by 2028, registering a compound annual development fee (CAGR) of 8.4 %.

Firm Highlights

• NeonMind has a method within the psychedelic sector with a twin deal with creating specialty psychological well being clinics and pioneering psychedelic drug improvement to advance psilocybin for power weight administration problems.
• It’s the primary and solely firm growing novel psilocybin-based therapies to deal with the US$326 billion by 2028 international weight administration market, representing an unlimited, untapped therapeutic space for psychedelics.
• Working with strategic companions, the NeonMind is constructing out a nationwide community of NeonMind-branded specialty psychological well being clinics in Canada, incorporating evidence-based interventional therapies to deal with a wide range of psychological well being wants.
• NeonMind partnered with two main specialty medical firms, SRx Well being and BioScript Options, which collectively function over 100 clinic areas all through Canada, permitting NeonMind to announce its inaugural location in Mississauga, Ontario.
• The corporate is led by an skilled administration staff with expertise in biotech and healthcare and main scientific and medical advisors within the area of psychedelics and psychiatry.

NeonMind will create a community of specialty clinic therapy facilities that may legally administer therapies with authorised medicine categorised as psychedelics together with ketamine and esketamine. It has established partnerships with main specialty medical therapy firms SRx Well being and BioScript Options to roll out these revolutionary therapies. This initiative represents the corporate’s short-term technique to start out producing income.

Venture Highlights:

• Concentrating on Excessive-Influence Remedy Choices: NeonMind has chosen therapies and areas with sturdy demand however with a provide hole attributable to lack of availability to therapy areas. NeonMind will enter these markets and have an instantaneous impression on therapy availability for these sufferers.
• Scalable and Environment friendly Mannequin: NeonMind has constructed its working mannequin to be scalable and effectively deployed with its companions which have entry to over 100 clinics all through Canada.
• Speedy Rollout In Anticipation of New Therapies: Following the inaugural clinic, three further clinics will likely be introduced in 2023, with a further six clinics in 2024. Rising market adoption, pushed by therapy availability and medical proof, is predicted. Moreover, new psychedelic therapies will likely be supplied at these clinics, as soon as authorised.

Two drug candidates are presently being developed that make the most of psilocybin in numerous doses. NEO-001 makes use of a excessive dose of psilocybin to enhance psychotherapy classes, with a view to induce lasting life-style adjustments. NEO-002 has a low dose of psilocybin and will likely be prescribed for continued urge for food suppression.

Venture Highlights:

• A number of Drug Packages: The high-dose therapy deliberately induces a hallucinogenic impact to catalyze lasting adjustments, whereas the low-dose therapy will induce satiety with out the hallucinogenic impact.
• NEO-001 Has a Clear Medical Pathway: FDA steering has already been supplied for the excessive dose drug candidate and NeonMind is getting ready to provoke a first-in-class medical examine to deal with weight administration and weight problems
• A Rising Physique of Proof: NeonMind and different researchers proceed to find the constructive results of psilocybin because it pertains to weight administration. Latest animal research present a 30 % discount in weight achieve versus placebo with constructive results seen as early as three days of administration.

Administration Group

Robert Tessarolo – President & Chief Government Officer

Robert Tessarolo has over 25 years of expertise within the pharmaceutical trade. Former president, CEO and director of Thoughts Drugs (NEO:MMED). Thoughts Drugs was the primary psychedelics firm to record on a inventory alternate. Former president and CEO of Cipher Prescription drugs (TSX:CPH), Tessarolo expanded the product pipeline with seven enterprise improvement transactions that restored the corporate to constructive earnings earlier than curiosity, taxes, depreciation and amortization (EBITDA). He served as president of Watson Prescription drugs Canada and led the combination of main mergers and acquisitions. These included Warner Chilcott, an roughly US$5 billion international acquisition, Forest Laboratories an roughly US$28 billion international acquisition and Allergan an roughly US$66 billion international acquisition.

Rick Huang – Chief Monetary Officer

Rick Huang is the previous CFO of Higher Plant Sciences (CSE:PLNT) and has served as chair of the audit committee for Datable Expertise (TSXV:TTM) since 2015. Huang is the previous CFO of Hanwei Power Providers (TSX:HE) and beforehand served as chair of governance and member of audit committees at Poydras Gaming Finance (TSXV:PYD). He’s a Licensed Basic Accountant and a delegated Chartered Skilled Accountant in Canada.

Ernie Ho, PhD – Vice President of Company Improvement

Ernie Ho earned his doctoral diploma from Western College and brings over 15 years of improvement and commercialization expertise in main Canadian biopharmaceutical and diagnostic firms from preclinical improvement to product administration. He developed and efficiently launched progressive medical providers at Canada’s largest diagnostic supplier, LifeLabs, centered on consumer wants and improved affected person outcomes. Ernie has important profession success in company improvement, together with pivotal roles in licensing, mergers and acquisitions, and capital raises at Therapure Biopharma, now Resilience Biotechnologies, and Cipher Prescription drugs (TSX:CPH).

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

Dr. Sagar Parikh is a Professor of Despair and Medical Neuroscience and Professor of Psychiatry on the College of Michigan. Dr. Parikh is the medical director on the Nationwide Community of Despair Facilities. He’s the creator and editor of three books and over 200 peer reviewed articles and e book chapters. Dr. Parikh co-authored the Canadian Community for Temper and Nervousness Therapies (CANMAT) therapy tips for melancholy and for bipolar dysfunction, the world’s most cited temper dysfunction tips.

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

Dr. Roumen Milev is the medical lead of Windfall Care Hospital Interventional Psychiatry. He oversaw greater than 1,000 sufferers efficiently handled with ketamine and neurostimulation modalities. Dr. Milev is the chief chair elect of the CANMAT and an government committee member of the Canadian Biomarker Integration Community for Despair (CAN-BIND). He authored and edited over 140 peer-reviewed articles and e book chapters. Dr. Milev additionally co-authored the CANMAT therapy guides.

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

Dr. Gustavo Vazquez is a Professor of Psychiatry at Queen’s College and the medical lead of Windfall Care’s ketamine clinic, treating greater than 100 sufferers with ketamine. Dr. Vazquez is an energetic analysis member of the Worldwide Consortium for Psychotic and Bipolar Issues Analysis, McLean Hospital and Harvard Medical Faculty. He’s additionally a fellow and energetic member of the Royal School of Physicians of Canada. Dr. Vazquez authored and edited over 130 peer-reviewed articles and e book chapters, along with two books, together with, “Ketamine for Remedy-Resistant Despair: Neurobiology and Functions”.

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

Dr. Daniel Bainbridge is the previous president of the Canadian Anesthesiologists Society and a member of the Royal School of Physicians of Canada. He labored as a professor within the Division of Anesthesia and Perioperative Drugs on the College of Western Ontario. Dr. Bainbridge was an anesthesia marketing consultant at London Well being Sciences Centre, serving on its Specialty Clinics Advisory Board. Dr. Bainbridge has 20 years of expertise in apply and management within the area of anesthesiology.

Philippe Martin – Chair of the Analysis & Improvement Advisory Board

Philipe Martin has 20 years of biotechnology and pharmaceutical trade expertise growing and commercializing progressive therapies within the fields of immunology, oncology and neurology. Chief of medical improvement and operations at BioAtla, Martin oversaw the event of pre-clinical and medical belongings. Beforehand, at Celgene, he led the Otezla® staff, earlier than which he led the remicade versus simponi iodine lifecycle technique at Schering-Plough.

Dr. Albert Garcia-Romeu, PhD – Member of the Analysis & Improvement Advisory Board

Dr. Albert Garcia-Romeau is an Assistant Professor of Psychiatry and Behavioral Sciences on the Johns Hopkins College Faculty of Drugs. He has carried out greater than 90 high-dose psilocybin classes within the laboratory since 2012. Dr. Garcia-Romeu is a founding member of the Johns Hopkins Heart for Psychedelic and Consciousness Analysis.