NeonMind Biosciences (CSE:NEON) Investor Overview

Overview

Psychedelics have taken middle stage as an rising remedy for psychological well being and behavioral issues. Main analysis institutes reminiscent of John Hopkins and biotechnology corporations have generated promising scientific knowledge on the efficacy and security of remedies utilizing psychedelics, with the main target in the direction of receiving regulatory approval and commercialization as medical remedies. These transformational remedies are each important and welcome medical improvements given the rising psychological well being epidemic and dependancy disaster which present remedies are inadequately addressing.

Of the various psychedelic compounds, psilocybin and MDMA are on the forefront of receiving approval with anticipation that these medication may very well be used as remedies in specialised medical clinics within the coming years. Latest human scientific research utilizing psilocybin have proven efficacy in each conventional psychiatric situations reminiscent of melancholy and anxiousness issues.

Research additionally counsel enchancment in behavioral and addictive situations reminiscent of consuming issues, smoking cessation, and drug use issues. Analysis has enabled clinicians to hone in on how greatest to manage these remedies. The widespread efficacy in a number of issues is an indication of a possible transformational medical remedy.

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

At the moment, sufferers can solely entry newer psychedelic remedies, reminiscent of psilocybin, by scientific research and particular entry applications till these remedies obtain regulatory approval. Psychological well being remedy choices with authorised medication categorised as psychedelics, reminiscent of 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 pointers.

A promising growth is the event of a brand new remedy utilizing the prevailing drug ketamine, has been developed for temper and anxiousness issues, exhibiting sturdy efficacy and security, and receiving suggestion within the Canadian pointers.

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

1. Establishing specialised psychological well being clinics that present presently out there remedies reminiscent of ketamine and esketamine and to supply different psychedelic remedies when authorised.
2. Specializing in drug growth of novel psychedelic remedies 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 remedies to pick out cities within the first half of 2022 and develop to extra places in 2023. Its first remedy, which was just lately introduced, can be to supply ketamine for the medical remedy of temper and anxiousness issues as really useful by the Canadian pointers.

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

NeonMind’s clinics will handle a serious hole within the Canadian market, specifically entry to progressive and validated psychological well being remedies with its first remedy specializing in ketamine. This technique not solely gives fast money movement but it surely additionally establishes a enterprise that may be leveraged to supply new psychedelic remedies 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 scientific research to deal with weight administration and weight problems. The corporate has developed two drug applications, certainly one 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 scientific trials and has obtained 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’ve a transparent plan for commercialization to maneuver our asset by to a brand new drug software 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 obtained their suggestions which was optimistic. With their suggestions, it established a transparent pathway to advancing our program, performing scientific research, after which submitting our drug candidate for regulatory evaluate.”

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 places of work. NeonMind’s long run technique will make the most of the profitable weight administration market, which has a rising market measurement that’s estimated to surpass US$326 billion by 2028, registering a compound annual development price (CAGR) of 8.4 %.

Firm Highlights

• NeonMind has a technique 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 continual weight administration issues.
• It’s the primary and solely firm growing novel psilocybin-based remedies to handle the US$326 billion by 2028 international weight administration market, representing an enormous, 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 remedies to handle quite a lot of psychological well being wants.
• NeonMind partnered with two main specialty medical corporations, SRx Well being and BioScript Options, which collectively function over 100 clinic places all through Canada, permitting NeonMind to announce its inaugural location in Mississauga, Ontario.
• The corporate is led by an skilled administration group with expertise in biotech and healthcare and main scientific and medical advisors within the subject of psychedelics and psychiatry.

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

Undertaking Highlights:

• Focusing on Excessive-Influence Remedy Choices: NeonMind has chosen remedies and places with sturdy demand however with a provide hole attributable to lack of availability to remedy places. NeonMind will enter these markets and have a right away 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 further clinics can be introduced in 2023, with an extra six clinics in 2024. Rising market adoption, pushed by remedy availability and scientific proof, is predicted. Moreover, new psychedelic remedies can be supplied at these clinics, as soon as authorised.

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

Undertaking Highlights:

• A number of Drug Packages: 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 Scientific Pathway: FDA steerage has already been offered for the excessive dose drug candidate and NeonMind is making ready to provoke a first-in-class scientific research 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 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 checklist on a inventory alternate. Former president and CEO of Cipher Prescribed 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 Prescribed drugs Canada and led the mixing 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 Vitality 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 Normal Accountant and a chosen Chartered Skilled Accountant in Canada.

Ernie Ho, PhD – Vice President of Company Growth

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 corporations from preclinical growth to product administration. He developed and efficiently launched progressive medical companies at Canada’s largest diagnostic supplier, LifeLabs, targeted on consumer 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 Prescribed drugs (TSX:CPH).

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

Dr. Sagar Parikh is a Professor of Despair and Scientific 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 guide chapters. Dr. Parikh co-authored the Canadian Community for Temper and Nervousness Therapies (CANMAT) remedy pointers for melancholy and for bipolar dysfunction, the world’s most cited temper dysfunction pointers.

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

Dr. Roumen Milev is the scientific 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 guide 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 scientific 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 Problems Analysis, McLean Hospital and Harvard Medical College. 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 guide 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 follow and management within the subject of anesthesiology.

Philippe Martin – Chair of the Analysis & Growth 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 scientific growth and operations at BioAtla, Martin oversaw the event of pre-clinical and scientific belongings. Beforehand, at Celgene, he led the Otezla® group, earlier than which he led the remicade versus simponi iodine lifecycle technique at Schering-Plough.

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

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