NeonMind Biosciences (CSE:NEON) Investor Overview

Overview

Psychedelics have taken heart stage as an rising remedy for psychological well being and behavioral problems. Main analysis institutes resembling John Hopkins and biotechnology firms have generated promising medical information on the efficacy and security of therapies utilizing psychedelics, with the main target 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 habit 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 may very well 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 resembling despair and nervousness problems.

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

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

At present, sufferers can solely entry newer psychedelic therapies, resembling psilocybin, by medical research and particular entry packages till these therapies obtain regulatory approval. Psychological well being remedy choices with accredited medicine labeled as psychedelics, resembling ketamine and esketamine, can already be accessed in specialised medical clinics as a result of they’re accredited by regulators and have been included in medical tips.

A promising growth is the event of a brand new remedy utilizing the prevailing drug ketamine, has been developed for temper and nervousness problems, displaying robust efficacy and security, and receiving advice within the Canadian tips.

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

1. Establishing specialised psychological well being clinics that present at the moment accessible therapies resembling ketamine and esketamine and to supply different psychedelic therapies when accredited.
2. Specializing in drug growth of novel psychedelic therapies specializing in their proprietary drug candidates to deal with behavioral deficits in sufferers with weight administration points and weight problems.

Relating to its specialty psychological well being clinics, NeonMind will start rolling out psychological well being therapies to pick out cities within the first half of 2022 and broaden to extra areas in 2023. Its first remedy, which was lately introduced, shall be to supply ketamine for the medical remedy of temper and nervousness problems as really useful by the Canadian tips.

NeonMind has partnered up with two main specialty medical remedy 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 tackle a serious hole within the Canadian market, particularly entry to revolutionary and validated psychological well being therapies with its first remedy specializing in ketamine. This technique not solely supplies rapid money move but it surely additionally establishes a enterprise that may be leveraged to supply new psychedelic therapies as they obtain approval.

The corporate’s different division, targeted on growth of psychedelic drug candidates, is making ready to provoke a first-in-class medical examine to deal with weight administration and weight problems. The corporate has developed two drug packages, one in every of 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 acquired optimistic 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 by to a brand new drug utility with the FDA as a result of we visited them within the fourth quarter of final yr, and we performed a pre-IND session assembly. We shared with the FDA our analysis plans, our designs, and we acquired their suggestions which was optimistic. With their suggestions, it established a transparent pathway to advancing our program, performing medical research, after which submitting our drug candidate for regulatory evaluation.”

Primarily based on the novelty of their analysis, patents for NeonMind’s revolutionary drug candidates are already pending with america Patent and Trademark Workplace (USPTO) and different worldwide patent places of work. NeonMind’s long run technique will benefit from 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 charge (CAGR) of 8.4 %.

Firm Highlights

• NeonMind has a method within the psychedelic sector with a twin give attention to creating specialty psychological well being clinics and pioneering psychedelic drug growth to advance psilocybin for persistent weight administration problems.
• It’s the primary and solely firm growing novel psilocybin-based therapies to deal with the US$326 billion by 2028 world 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 crew 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 remedy facilities that may legally administer therapies with accredited medicine labeled as psychedelics together with ketamine and esketamine. It has established partnerships with main specialty medical remedy firms SRx Well being and BioScript Options to roll out these revolutionary therapies. This initiative represents the corporate’s short-term technique to begin producing income.

Venture Highlights:

• Focusing on Excessive-Influence Remedy Choices: NeonMind has chosen therapies and areas with robust demand however with a provide hole as a consequence of lack of availability to remedy areas. NeonMind will enter these markets and have a direct impression on remedy 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 extra clinics shall be introduced in 2023, with an extra six clinics in 2024. Rising market adoption, pushed by remedy availability and medical proof, is anticipated. Moreover, new psychedelic therapies shall be provided at these clinics, as soon as accredited.

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

Venture Highlights:

• A number of Drug Applications: The high-dose remedy deliberately induces a hallucinogenic impact to catalyze lasting modifications, whereas the low-dose remedy will induce satiety with out the hallucinogenic impact.
• NEO-001 Has a Clear Medical Pathway: FDA steerage has already been offered for the excessive dose drug candidate and NeonMind is making 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 optimistic results of psilocybin because it pertains to weight administration. Latest animal research present a 30 % discount in weight achieve versus placebo with optimistic results seen as early as three days of administration.

Administration Staff

Robert Tessarolo – President & Chief Govt Officer

Robert Tessarolo has over 25 years of expertise within the pharmaceutical trade. Former president, CEO and director of Thoughts Medication (NEO:MMED). Thoughts Medication was the primary psychedelics firm to checklist on a inventory trade. Former president and CEO of Cipher Prescription drugs (TSX:CPH), Tessarolo expanded the product pipeline with seven enterprise growth transactions that restored the corporate to optimistic 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 world acquisition, Forest Laboratories an roughly US$28 billion world acquisition and Allergan an roughly US$66 billion world 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 Know-how (TSXV:TTM) since 2015. Huang is the previous CFO of Hanwei Power Companies (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 growth and commercialization expertise in main Canadian biopharmaceutical and diagnostic firms from preclinical growth to product administration. He developed and efficiently launched revolutionary medical providers at Canada’s largest diagnostic supplier, LifeLabs, targeted on shopper wants and improved affected person outcomes. Ernie has important profession success in company growth, 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 writer 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) remedy tips for despair 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 remedy 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 lively analysis member of the Worldwide Consortium for Psychotic and Bipolar Problems Analysis, McLean Hospital and Harvard Medical Faculty. He’s additionally a fellow and lively member of the Royal Faculty 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 Purposes”.

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 Faculty of Physicians of Canada. He labored as a professor within the Division of Anesthesia and Perioperative Medication on the College of Western Ontario. Dr. Bainbridge was an anesthesia advisor at London Well being Sciences Centre, serving on its Specialty Clinics Advisory Board. Dr. Bainbridge has 20 years of expertise in follow 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 revolutionary therapies within the fields of immunology, oncology and neurology. Chief of medical growth and operations at BioAtla, Martin oversaw the event of pre-clinical and medical belongings. Beforehand, at Celgene, he led the Otezla® crew, 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 Medication. He has performed 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.