Corporate Presentation - Nova Mentis

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Corporate Presentation June 2022

Transcript of Corporate Presentation - Nova Mentis

Page 1: Corporate Presentation - Nova Mentis

Corporate Presentation

June 2022

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Forward-Looking Statements

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Nova Mentis Life Science Corp.

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A Canadian-based biotechnology company and global leader in psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders.

Our approach is to combine psychedelic drug development with hard biological endpoints that confirm subjective behavioural changes.

Company focuses on serious illnesses with unmet medical needs, such as autism spectrum disorder (ASD) and fragile X syndrome (FXS).

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CSE: NOVA | OTCQB: NMLSF | FSE: HN3Q

The first biotech company to receive psilocybin orphan drug designation in the U.S. and European Union, which will greatly assist us on the pathway to drug approval.

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Novel psychedelic portfolio focuses on the physiologic therapeutic response of serotonin receptors in the brain and the human peripheral organs.

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The Nova Mission

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Drug portfolio includes patentable manufacturing technology to produce psychedelic compounds such as psilocybin, baeocystin and aeruginascin. We have established a unique PDMO partnership with a company that has expertise in API development and cGMP manufacturing.

Chemical CompoundsSerotoninNeuroinflammation

The objective is to treat neuroinflammatory disorders, including but not limited to autism spectrum disorder, neurodegenerative diseases, obesity and diabetes.

We are utilizing state-of-the-art diagnostic and therapeutic technology-mRNA inflammatory genetic markers, microbiome examination of the oral-gut-brain axis, cytokine biomarkers and deep learning artificial intelligence.

The Nova Answer

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Nova’s Drug Portfolio PipelineManufactured under our unique PDMO (partnership development and manufacturing organization)

Focusing on chronicneuroinflammatory conditions, Nova is developing a robust, diversified pipeline in multiple indications with high unmet medical needs.

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PROJECT COMPOUND TARGET PRECLINICALCLINICAL PHASE I (HUMAN)

CLINICAL PHASE II (HUMAN)

NM-1001Psilocybin

Genetic and non-genetic ASD & FXS

NM-1014Psilocin

Genetic and non-genetic ASD

NM-1019Baeocystin

Genetic and non-genetic ASD

NM-1020aeruginascin

Genetic and non-genetic ASD

NM-1021Entourage Formulation:

psilocybin, baeocystin

and aeruginascin

Genetic and non-genetic ASD

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Phase 2 Clinical TrialApplication(Q3 2022)

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The Nova Drug Portfolio

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Nova's proprietary drug portfolio containing greater than 95 percent pure synthetic psilocybin, psilocin, baeocystin and aeruginascin will allow the creation

of unique formulations with potential therapeutic applications.

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We are taking a unique approach and will be utilizing statistically objective diagnostic tools to measure psychedelic drug response, instead of relying on

behavioural methods alone.

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We will be testing the potential “entourage effect” of using psilocybin, psilocin, baeocystin and aeruginascin in concert.

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“Why is the world just focusing on the behavioural aspects of psilocybin? The mushroom is a natural food and we need to research it's full therapeutic potential. Nature is perfect.”- Dr. Marvin S. Hausman,

Chairman of Nova’s Scientific Advisory Board

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Transdermal and injectable formulations are being developed for planned human studies.

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A New Approach to Neuroinflammatory Disorders

Stressed Status

Healthy Status

• Normal gut microbiota• Normal digestive function• Normal mood and behaviour• Normal immune response

• Altered gut microbiota• Altered digestive function• Alterations in mood

and behaviour• Altered immune response

“By measuring levels of genetic mRNA, inflammatory molecules, and serotonin, Nova is establishing itself as a leader in thedevelopment of objective biologic endpoints to validate subjective behavioral changes in people receiving psychedelic therapy.”

- Dr. Kyle H. Ambert, Director of Data Science at Nike, Inc.

and member of Nova’s Scientific Advisory Board

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Nova’s Unique Integrated Systems Clinical Approach to Drug DevelopmentStudying three systems – the immune system, neuroinflammatory biomarkers and behaviour – can lead to new therapeutic applications

Clinical Applications:

• Autism Spectrum Disorder• Fragile X Syndrome• PTSD• Depression• Parkinson’s disease• Alzheimer's disease• Diabesity

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Disease

NeuroinflammatoryBiomarkers

BehaviouralAnalysis

Immune System

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World Class Expert Collaboration

NIS Labs (United States)Tested psilocybin and psilocin for cellular bioavailability and anti-inflammatory capabilities in a preclinical red blood cellbioassay.

Thermo Fisher (Austria)Testing ASD serum samples for inflammatory and immune system markers.

API Proprietary Manufacturing Agreement(United States)Producing psilocybin, psilocin and associated tryptamine derivatives for an ‘Entourage Effect.’

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Comac Medical Ltd (Bulgaria)Designing and performing pharmacokinetic and Phase 1 clinical studies, as well as assisting in European regulatory filings for drug approval.

Roma Tre University (Italy)Dr. Viviana Trezza from the Department of Science is providing three preclinical unique ASD models.

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Transdermal Delivery Technology (San Diego, CA)Research partnership under discussion.

Genetic mRNA TechnologyResearch partnerships under discussion.

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Enables penetration of the genetic language underlying the development of neurodegenerative diseases, assesses therapeutic responses and opens the door for the development of breakthrough products in psychedelic medicine.

The clinical biomarker data generated with this genetic paradigm can be used to support the potential benefits of a psychedelic drug product IND application with the U.S. FDA.

Messenger RNA Technology (mRNA)Application of a unique paradigm to assist in our psychedelic drug development program

Novel mRNA technology can monitor pre- and post-neuroinflammatory drug treatment response.

Nova is acquiring FDA Real World Evidence (RWE) to prove drug efficacy.

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Proprietary manufacturing process owned exclusively by Nova.

Patent Portfolio

United States Provisional Manufacturing Patent (July 2021)

Worldwide Diagnostic Neuroinflammatory PCT Application (Nov. 2021)

Provides protection for diagnosing, monitoring and treating neuroinflammatory disorders with psilocybin and psilocybin-based tryptamine derivatives; Describes unique mRNA neuroinflammatory diagnostic technology.

Manufacturing of psilocybin, psilocin and other tryptamine derivatives, such as baeocystin and aeruginascin.

This technology can be used by the pharmaceutical industry to evaluate efficacy of many drugs in the treatment of chronic neuroinflammatory disorders.

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Financial Benefits

Exclusivity Research Assistance

Grant Access

Tax credits and reduced fees; Waiver of the U.S. Prescription Drug User Fee Act fees: a value of approximately $2.9 million.

Seven years of U.S. market exclusivity and 10 years of European exclusivity: The same drug cannot be approved for the same indication.

Eligibility to receive scientific advice, regulatory assistance and guidance in the design of an overall drug development plan.

Ability to qualify to compete for research grants to support clinical studies.

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Orphan Drug Designation for Fragile X SyndromeThe first biotech company to receive psilocybin orphan drug designation in the U.S. and European Union

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Currently enrolling 300+ participants: 200+ with diagnosed autism (ASD) and/or fragile X (FXS); 100+ neurotypical controls.

Institutional Review Board (IRB) approved study in the U.S. and Canada.

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Studying the neuroinflammatory mRNA genetic profile and serotonin levels to help further understand the development and progression of behavioural symptoms observed in ASD and FXS.

The data will be analyzed with the help of advanced machine learning computational methods incorporated in the design of upcoming clinical trials that will test efficacy of psilocybin in ASD and FXS.

North American Autism Observational StudyEstablish specific treatable subsets of ASD and confirms drug response

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Nova aims to uncover more precise ways to diagnose and treat autism spectrum disorder (ASD) and fragile X syndrome (FXS) – unmet medical needs.

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Accomplishments to Date: Psilocybin Drug Development Breakthroughs

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Psilocybin Proof of Efficacy and Safety

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Worldwide ASD Observational Study

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Orphan Drug Status FDA and EMA

Large Clinical Psilocybin Supply for Human Studies

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“Nova has launched the necessary research and development steps needed for successful drug regulatory approval and future commercialization.”

- Dr. Marvin S. Hausman, Chairman of Nova’s Scientific Advisory Board

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Strategic PartnershipsInnovation and Expertise to Advance Nova’s Research and Drug Development Program

Psilocybin Microdose Capsules

Contract with TIPT to formulate and manufacture psilocybin microdosecapsules for Nova’s upcoming Canadian Phase 2A fragile X syndrome clinical study.

Canadian Psilocybin Drug Portfolio

KGK will help develop Nova’s psilocybin drug portfolio in Canada and jointly submit a clinical trial application to Health Canada for a Phase 2A clinical study evaluating psilocybin microdose therapy for FXS.

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Saliva Serotonin Assay

Research agreement with UCF to develop a potential groundbreaking serotonin assay to help us predict autism development and establish treatable subsets.

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The Nova StoryProgress and Achievements over the Past 12 Months

Psilocybin export application approved by the U.S. DEA; Successful shipment of non-GMP >98% purity psilocybin to research investigator, Dr. Viviana Trezza, Roma Tre University, Rome, Italy.

Psilocybin treatment achieves successful modulation of anxiety symptoms displayed in VPA-exposed rats and cognitive improvement in the fragile X syndrome (FXS) animals.

Nova proprietary synthetic non-GMP psilocybin proof of efficacy and safety established in 4 preclinical ASD models.

Launched North American Institutional Review Board (IRB) approved clinical autism spectrum disorder (ASD) Observational Study.

Approval granted of Orphan Drug Status from U.S. FDA and European Medicines Agency (EMA) for psilocybin treatment of FXS.

Research:

Products:

Proprietary psilocybin manufacturing agreement (PDMO); Ownership of Drug Master File (DMF).

Manufactured psilocybin, non-GMP >98% purity. Completed manufacture of two other derivatives: baeocystin and aeruginascin.

Successful manufacture of large clinical supply of cGMP psilocybin for human clinical studies.

Patents:

Successful patent filing: U.S. provisional drug manufacturing patent for Nova's unique manufacturing process and Drug Master File (DMF).

Developed and filed worldwide patent on diagnostic/therapeutic system to determine pre-and post-treatment psychedelic response in patients with neuroinflammatory disorders.

Oral microdose study showed that repeat low doses of our psilocybin drug significantly modulated behavioural and cognitive defects in FXS.

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The Nova StoryCurrent Research and Development

Manufactured psilocybin, baeocystin and aeruginascin for design of entourage formulations; preclinical studies scheduled with Dr. Trezza, Rome, Italy.

Develop clinical biologic marker program to confirm behavioural changes in treated patients in response to psychedelic drug treatment.

Joint venture with Mycrodose Therapeutics to develop transdermal psilocybin patch; Schedule 1 license completed and drug shipped to R&D facility in San Diego, CA.

Human Observational ASD study; Institutional Review Board (IRB) approved in U.S. and Canada.

Establish biomarker data bank to be used in Phase 2 regulatory drug study to show response to therapy; U.S. and Europe.

Negotiate strategic relationship with a major university regarding serotonin research. Cooperative clinical setting for enrolling ASD patients in Observational study and future FDA study.

Design Phase 2A psilocybin fragile X syndrome IND to be submitted to U.S. FDA, Health Canada and EMA.

Designing AllHealth Portal ™ app for ASD. Clinical and behavioural data.

Strategic partnerships to promote psychedelic drug development and commercialization.

Preparation of psilocybin manufacturing process file in support of Phase 2 IND filing with U.S. FDA, Health Canada and EMA.

Submission of Phase 2A IND Application to U.S. FDA and subsequently to EMA.

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Autism Spectrum Disorder: Market Reports

$4.6 billionThe therapeutics markets for ASD in the US forecasted by 2026.1

1 in 54 childrenThe number of people the CDC (Centers for Disease Control and Prevention) stateshas been identified with ASD.

up to $4.7 millionThe estimated lifetime cost of supporting an individual with ASD.2

$461 billionThe economic cost of ASD in the US forecasted by 2025.1

1. J Autism Dev Disord—Brief Report: Forecasting the Economic Burden of Autism in 2015 and 2025 in the US.

2. Ontario Autism Coalition.

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Scientific Leadership

Dr. Hausman is an Immunologist and Board-Certified Urological Surgeon with more than 30 years of drug research and development experience with various pharmaceutical companies, including Bristol-Myers International, Mead-Johnson Pharmaceutical Co., E.R. Squibb, Medco Research, and Axonyx.

Marvin S. Hausman, MDChairman of the Scientific Advisory Board, Nova Mentis Life ScienceChief Medical Officer, Pilz Bioscience

He was a co-founder of Medco Research Inc., a NYSE-listed clinical research organization and biotechnology company specializing in adenosine products that was subsequently acquired by King Pharmaceuticals. He was also a co-founder of Axonyx, and served in various capacities as President, CEO and Chairman until the company merged into NASDAQ-listed Torrey Pines Therapeutics Inc. in 2006.

Dr. Hausman is currently a Director of NuGenerex ImmunoOncology Biotechnology Corporation and is Chairman of the Board of Directors and Chief Science and Technology Officer of Entia Biosciences Inc.

He has done residencies in General Surgery at Mt. Sinai Hospital in New York, and in Urological Surgery at UCLA Medical Center. He received his medical degree from New York University School of Medicine. He is on the Alumni Board of Governors of NYU Grossman School of Medicine.

“The mushroom isone of the most valuable foods. It’s a fascinating kingdom -created by nature, unlocked by science.”

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Scientific Leadership

Specializing in scientific discovery and corporate strategy, Dr. Perederiy holds expertise along the full spectrum of biological innovation, from single-cell analytics to systems-level therapeutics. She is an author of multiple peer-reviewed publications, including highly regarded studies on the neurogenetics of autism and brain plasticity in neurodegeneration.

She holds Bachelor’s degrees in Neurobiology and Psychology from the University of California, Berkeley, a Master’s in Technology Entrepreneurship from University of Portland and a PhD in Neuroscience from Oregon Health & Science University.

Dr. Julia PerederiyLead Scientist, Strategic Advisor

Faculty at Roma Tre University in Rome, Italy, Dr. Trezza investigates the brain mechanisms underlying functional and dysfunctional socio-emotional behaviour, with the long term of goal of identifying novel pharmacological targets for neuropsychiatric and neurodevelopmental disorders characterized by aberrant socio-emotional processing. A special emphasis in her studies is also placed on the role of the endocannabinoid system in the regulation of emotions and cognition through development.

Dr. Viviana TrezzaPreclinical ASD Study Liaison

Mr. Molinaro is a Board Certified Behaviour Analyst (BCBA) with a Master's degree in Applied Behaviour Analysis, as well as a Bachelor's degree in Psychology. For more than 13 years, Mr. Molinaro has dedicated his life to supporting children, youth and adults challenged with physical and cognitive disabilities. Since 2015, Mr. Molinaro shifted his efforts primarily towards the autism community and started the Colours of the Spectrum ABA autism clinic in 2018.

Dr. Kyle AmbertPreclinical ASD Study Liaison

John Molinaro

Dr. Ambert is currently Director of Data Science at Nike, Inc. and has extensive experience in data analytics, machine learning, artificial intelligence and applied analytics. His previous experience includes postings with the National Library of Medicine and Intel Corp. Dr. Ambert holds a PhD in Biomedical Informatics from Oregon Health & Science University.

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Board of Directors

William RascanPresident & CEO

Mr. Rascan brings +30 years’ experience in the investment brokerage/capital markets industry, currently as President & CEO of Nova Mentis Life Science Corp (formerly Liberty Leaf Holdings) and previous to that, as CEO of Weststar Resources.

Jacqueline McConnellCOO & Director

Jacqueline McConnell has over twenty years of experience working for Apotex Inc., one of Canada’s largest pharmaceutical companies. She provides critical business strategy input at a senior leadership level to support an organization’s ability to achieve local and global growth and corporate sustainability.

Rebecca Hudson, CPA, CACFO

Ms. Hudson has over 23 years of experience in accounting and financial reporting, corporate finance, risk management, financial audit and corporate governance, serving a wide range of industries. She holds a Bachelor’s Degree and Masters of Accounting from the University of Waterloo.

Steven FeldmanDirector

Mr. Feldman has more than 25 years' experience in the capital markets. Notably, Mr. Feldman was part of the original management team of SouthGobi Resources that evolved from a $20 million market cap explorer to a $2 billion+ market cap coal producer.

Kelly PladsonCorporate Administrator

Kelly Pladson has provided corporate governance and regulatory compliance services to many TSX Venture and CSE listed companies since 2009.

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Dr. Stephen GlazerChief Science Officer & Director

Dr. Glazer brings 30 years of medical experience to the Board. He’s worked in areas such as pre-operative risk assessment, cardiology and diabetes, and is a national leader and specialist in bariatrics, the branch of medicine that deals with people living with obesity. He’s currently the Medical Director for Bariatrics at Humber River Hospital in Toronto.

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Pharma Experience and Expertise

Team members possess experience in various facets of drug discovery, drug development, regulatory approval and operations within leading biotech and pharmaceutical enterprises.

Capital MarketsEXPERIENCE

Big PharmaEXPERIENCE

Drug ApprovalsACHIEVED

Fortune 100 and Non ProfitsEXPERIENCE

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Connect with Nova

Phone: 778-819-0244

[email protected] | www.novamentis.ca

700-838 W Hastings Street Vancouver, BC V6C 0A6Canada

CSE: NOVA | OTCQB: NMLSF | FSE: HN3Q

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