Post on 17-Apr-2022
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Leading psychedelic innovation forglobal healing and wellness
August 8, 2021 TSX.V: NUMI | OTC: LKYSF
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Forward Looking StatementsThis presentation contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation,statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and any inability to obtain all necessary governmental approvals licenses and permits to operate and expand the Company’s facilities; engaging in activities which currently are illegal under Canadian federal law and the uncertainty of existing protection from Canadian federal or other prosecution; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry as well as the use of psychedelic therapies, delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability, including closing of the financings contemplated herein; competition, including from more established or better financed competitors; the Company’s ability to withstand the economic impact of the COVID-19 pandemic; and the need to secure and maintain corporate alliances and partnerships, including with customers and suppliers. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
Industry firsts in natural psilocybin and MDMA research, backed by partnerships with sector leaders.
Deep proprietary moat with multiple product and therapeutic protocol advances.
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Welcome to Numinus.
Proven team with deep medical, scientific, market expansion and capital-raising experience.
Comprehensive model advancing scientific innovation and best-in-class clinical delivery.
Secured assets with lab and federal licence to pursue research, partnerships and revenue-generating contracts.
Steady clinic expansion led by medical leaders with psychedelic training and regulatory expertise.
Sustainable revenue and operations across lab and clinics to advance on global scaling strategy.
Developing proprietary, psychedelic-centred, therapeutic products and services through our own laboratory and R&D process, to be delivered through a global network of physical locations, digital solutions and partnerships.
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Payton NyquvestChief Executive Officer & Co-founderFormer capital markets executive who has raised $150M+ for public and private companies across North America. Formerly led one of Canada’s largest brokerages.
Stacey WallinChief Strategy Officer & Co-founderFormer founder of biotech wearables startup which scaled to serve Fortune 100 clients. Tech experience spans Canada and US, and includes growth, scaling and policy change. Founder of the Canadian Accelerator/ Incubator Network.
Dr. Evan Wood, MD, PhDChief Medical OfficerRenowned medical research and policy leader specialized in substance use, with deep experience collaborating with federal regulators and leading institutions to inform development of clinical guidelines and policies. Established Canada’s first supervised injection site and national guidelines for substance use disorders. Former Tier 1 Canada Research Chair, UBC professor, founding Executive Director of BC Centre on Substance Use. Has published 500+ scientific articles.
Michael Tan, MBA Chief Operations OfficerCareer leader in business transformation at the executive level for multinational companies, including Indigo and Hudson’s Bay. Launched BC’s provincial cannabis operations as first Executive Director of the BCLDB Cannabis Division.
John Fong, CPA, CGAChief Financial Officer15+ years establishing global financial operations for private and public companies across mining, resources and technology. Previously led a precious metals company from exploration to commercial production in 3 years, with net income of $100M and operating cash flow of $98M.
Dennis McKenna, PhDGeneral AdvisorRenowned ethnopharmacologist, psychedelic medicine pioneer, lecturer and author. Co-founder and director of ethnopharmacology at the non-profit Heffter Research Institute.
Dr. Gabor Maté, MD, CMClinical AdvisorRetired physician and renowned thought leader sought after for expertise on trauma, addiction, stress and childhood development. International speaker, bestselling author and Order of Canada holder.
Julie SaundersChief Marketing OfficerExperienced marketing, communications and creative executive specialized in luxury retail and hospitality industries, with 15+ years’ experience spanning major US and global markets. Led national and international brand launches and development of global integrated, omnichannel strategies. Past companies include Ace Hotels, Graduate Hotels, Saks Fifth Avenue, Sotheby’s, Christie’s.
Management & key advisors
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Sharan SidhuScience Officer & General ManagerExtensive experience developing strategy for research roadmaps, IP and product development. Experienced in regulatory affairs across Cannabis, Natural Health Products, Foods in North America and globally.
Dr. Devon Christie, MD, CCFP, IFMCP, RTCVP, Clinical & Psychedelic ServicesFamily physician and Registered Therapeutic Counsellor trained by MAPS to deliver and instruct on MDMA-assisted psychotherapy for PTSD. Certified across multiple therapy modalities including ketamine-assisted psychotherapy.
Dr. Joe Flanders, PhDVP, PsychologyLicensed clinical psychologist and assistant professor of psychology at McGill University. Founded Mindspace in 2011 as original owner-operator before 2021 acquisition by Numinus. Specialized in mindfulness-based therapy, with advanced certification from the University of Toronto and The Centre for Mindfulness Studies.
Dr. Evan LewisVP, Psychedelic Neurology ServicesPediatric neurologist and clinical neurophysiologist specialized in epilepsy. Founder & Director of the Neurology Centre of Toronto (NCT). Assistant Professor with the Department of Pediatrics at the Hospital for Sick Children and the University of Toronto.
Dr. Kristina Grotzinger, PhDSenior Research Scientist20 years’ phytochemistry experience in regulated lab environments. Health Canada-certified Qualified Person in Charge (QPIC). Undertaken SR&ED projects in analytical methods for cannabis testing. Avid researcher and lecturer in health/herbal medicines and author of peer-reviewed research papers.
Dr. Lindsay Mackay, MD, CCFPPrincipal InvestigatorClinician-scientist and addictions specialist physician with research training through NIDA-funded Clinical Research Fellowship, with extensive experience in the exploration of psychedelics and novel therapies as treatments for mental health and addictions. Principal Investigator of Numinus Phase 2 trial of psilocybin for substance use disorders.
Dr. Elena Argento, PhD, MPHCo-Principal Investigator, Research ScientistExperienced in psychedelic research, including studies of naturalistic and clinical use. Collaborating with BC Centre on Substance Use on interventions for the overdose crisis. Postdoctoral Researcher at UBC. Co-Principal Investigator of Numinus Phase 2 trial of psilocybin for substance use disorders.
Dr. Bernd O. Keller, PhDSenior Research Scientist20+ years’ experience in advanced analytical technologies and methods. Authored 30 peer reviewed publications. Former research scientist for BC Children's Hospital and director of mass spectrometry facility at Queen's University.
Research & clinical leadership
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Mental health care is in need of change
1.”Substance use and addiction”, Canadian Mental Health Association, https://ontario.cmha.ca/addiction-and-substance-use-and-addiction/.2. “Traumatic Stress Section: Facts About Traumatic Stress and PTSD”, Canadian Psychological Association, https://cpa.ca/sections/traumaticstress/simplefacts/. 3.The Lancet, Volume 396, Issue 10259, P1316-1318, October 24, 2020.4. Emergency department visits by adults for psychiatric medication adverse events. JAMA Psychiatry. 2014 Sep;71(9):1006-14. doi: 10.1001/jamapsychiatry.2014.436.5. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858.6. “COVID-19 disrupting mental health services in most countries, WHO survey”, World Health Organization, https://www.who.int/news/item/05-10-2020-covid-19-disrupting-mental-health-services-in-most-countries-who-survey.
Current systems are not equipped to handle skyrocketing global rates of mental illness, addiction and trauma.
72,000 overdose deaths in USreported in 2019 alone, with two-thirds involving opioids3
Approximately 1 in 11 peoplewill have PTSD in their lifetime1
1 in 5 people will suffer from substance use disorder2
COVID-19’s devastating impactalready underfunded mental health services have been disrupted in most countries, according to the World Health Organization6
971 million worldwidehave a mental or substance use disorder (pre-COVID-19 numbers)5
80,000+ psychiatric drug adverse events in USreported in emergency departments per year4
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Psychedelic medicine is transforming health care
1. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder. JAMA Psychiatry. 4 Nov 2020.doi:10.1001/jamapsychiatry.2020.3285.2. The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD. PLOS ONE. 14 Oct 2020. https://doi.org/10.1371/journal.pone.0239997.3. Efficacy of Ketamine in the Treatment of Substance Use Disorders: A Systematic Review. Frontiers in Psychiatry. 24 Jul 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094990/
● Psilocybin may relieve major depression with 4x the efficacy of traditional antidepressants¹
● MDMA for PTSD shows substantial clinical impact and potential annual savings of millions of dollars²
● Ketamine effective for depression as well as for alcohol and heroin-dependent individuals3
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Regulations are catching up
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February 2021
Missouri congressperson proposes Right to Try bill to allow prescribed access for seriously ill patients to various psychedelics, including LSD, MDMA and psilocybin
March 2021Washington, DC Initiative 81 allows DC residents to use plant and fungi medicines without fear of being investigated, arrested or jailed
June 2021California senate advances legislation to decriminalize psychedelic drugs
June 2021Texas bill passes requiring the state to study psilocybin therapy for veterans with PTSD
2018
FDA begins to recognize ‘breakthrough therapy’ status
August 2020Health Canada approves psilocybin therapy for select patients with terminal illness
November 2020Oregon legalizes psilocybin mushrooms for use in therapy
December 2020Health Canada proposes allowing controlled psychedelic access outside clinical trials
-MDMA for PTSD-Synthetic psilocybin for Treatment-Resistant Disorder
-Synthetic psilocybin for Major Depressive Disorder
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The market is waiting
1. Lancet Commission on Global Mental Health and Sustainable Development, 20182. “Mental Health”, World Bank, https://www.worldbank.org/en/topic/mental-health, May 20153. Canaccord Genuity, ‘Around the Corner’, May 2020
$100B+Total addressable market for mental health, global annual
$16TCost of inaction on mental health crisis
by 2030
$2.5T-$8.5T
Global annual economic output lost to mental, neurological
and substance use disorders
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Numinus leads the way
Powered by implementation science and business intelligence
Network of clinics delivering treatments for addiction, mental illness, neurological disorders and related conditions.
Health Canada-licensed lab developing IP, advancing research and generating revenue through services.
An integrated health care innovation & delivery model to advance healing at scale
Numinus Bioscience OverviewGlobal leader in Psychedelics R&D and Analytics that is foundational in building the industry by facilitating and supporting internal and external development goals.
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LocationBritish Columbia, Canada
Assets● Health Canada Controlled Drugs & Substances licence
○ Activities: Possession, Production, Assembly, Sale, Export, Delivery, Analytical Testing, R&D
○ Substances: DMT, Ketamine, LSD, Mescaline, MDMA, Psilocybe fruiting bodies/extracts, Psilocin, Psilocybin
● 7,500 sq. ft. state of the art facility equipped with next generation analytical tools & an additional 7,500 sq. ft. expansion in progress.
● Industry leading team with expertise in analytical chemistry, molecular biology, botanical extraction, mycology and formulation sciences.
Key activities● Cultivation, production and extraction of natural Psilocybe and
other psychoactive fungi species
● Development of proprietary processes and products
● Standardized methods for controlled psychedelics
● Pipeline for product development, protocol development and
safety and efficacy studies.
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Drug discovery and efficacy of natural compounds
● Discovery and characterization of compounds of therapeutic benefit beyond indole alkaloids.
● Discovery and characterization of new compounds with potential bioactivity and therapeutic benefit.
● Development pathway for novel compounds for in vitro & in vivo safety and efficacy.
STEP 1Discovery & Development
STEP 2Preclinical Research
STEP 3Clinical Research
Using next generation analytical tools Numinus Bioscience is on the path to discovery.
13Numinus’s Targeted Patent TypesInnovations in psychedelic extracts through proprietary advancements in technology
Patent Family 1
Process drivenProvisional Patent Submitted to US Patent Office for process to derive extracts from psychoactive mushrooms
Goal● Increase efficiency by 75%● Increase scalability, reproducibility and
reduce variability.● Reduce cost and increase regulatory
confidence
Next Steps● Scale up proof of concept● Validate methods● Produce variant extracts
Formulation & delivery drivenApply delivery technologies to extracts derived from patent pending technology (Family 1) to generate innovative dosage delivery systems.
Goal● Develop products with proven bioavailability.● Develop products that are stable for longer
periods, driving cost reduction.● Develop products accepted in multiple
regulatory jurisdictions with proven scientific data sets for quality, safety and efficacy.
Next steps ● Formulation studies using first
proprietary extract Psybina™● Submission of patents for unique
formulary with scientific data sets
Indication drivenEvidence based specific indication in vitro and in vivo studies for patents related to specific extract-formulation-indication.
Goal● Develop portfolio of evidence-based
products.
● Specifically target indications by assessing
bioactivity
● Leverage synergistic compounds within
natural extracts.
Next steps ● In vitro assays for bioactivity● Close assessment of interplay between
exogenous compounds and delivered myco-compounds
Patent Family 2 Patent Family 3
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Product Innovation Pipeline14
SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP
Innovative dosage delivery systems for efficient LSD delivery system.
Innovative dosage delivery systems for efficient MESCALINE delivery system.
Innovative dosage delivery systems for stabilized indole alkaloid complex matrices(Natural Psychoactive Mushroom Extracts)
Innovative dosage delivery systems for efficient KETAMINE delivery system.
2020 2021
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Advancing psychedelic science
Psilocybin-assisted psychotherapy for substance use disorders
MDMA-assisted therapy for PTSD with MAPS
Trial typePhase 2, compassionate access (Canada)
Status: Pre-implementation● Protocol peer-reviewed and finalized● Investigators and key staff appointed● Physical infrastructure established
Next Steps● Health Canada and ethical approvals
prior to study commencement in fall 2021
● A range of subsequent milestones will provide steady newsflow through 2022-2023
Trial typePhase 3, compassionate access (Canada)
Status: Pre-implementation● Received Health Canada approval● Principal investigators and key staff
appointed● Therapists trained through MAPS● Protocol developed and key staff
appointed
Next steps ● Ethical approval prior to study
commencement in fall 2021● A range of subsequent milestones
will provide steady newsflow through 2022-2023
Safety and efficacy of proprietary natural psilocybin extractionTrial typePhase 1, clinical assessment of natural Psilocybe extract derived from patent pending technology.
Status: IP Validation and study preparation● Protocol and Investigator's Brochure
developed by Numinus R&D team (Complete Fall 2021)
● Master File Submission to Health Canada (Complete Fall 2021)
● Technology scale up and development of efficient dose delivery technologies (Complete Fall 2021 with additional patentable technology)
● Anticipated - Approval Winter 2021, Implementation Jan/Feb 2022
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1st Global Psychedelics-Centered Contract Research OrganizationExperience in product development and R&D and clinical research enables fee-based and royalty-entitled value creation by serving external clients from discovery to market.
● Regulatory Support
● Product Development & R&D
(Numinus Bioscience)
● Medical Writing
● Pharmacovigilance
● Project Management
● Data Management
● Statistical Analysis
● Quality Assurance & Control
● Bioanalysis
● Strategic Consulting
● Market Access
● Drug Distribution
Numinus Health OverviewClinic network providing a wide range of psychedelic and non-psychedelic services for comprehensive, holistic mental health treatment.
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Locations● Vancouver — The Drive● Toronto — Neurology Centre of Toronto (NCT)● Montreal — Mindspace Wellness (2)
Current services● Ketamine-assisted psychotherapy (KAP) for depression● Neurologic care● Psychotherapy and counselling
Active developments● Clinic acquisitions and ground up clinic establishment● KAP protocols for various clinical indications● Psychedelic neurology programming● Therapeutic protocols for other psychedelic substances● Clinic sites to serve as locations for clinical research
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Progress in the clinicsSteady expansionAcquired sector-leading mindfulness and neurology clinics in Montreal and Toronto for 2021 expansion. Vancouver clinic designated as clinical trial site alongside patient services.
Superior patient experienceClinics renovated to industry-leading standards for psychedelic programs.
Dedicated leadership driving experience design and innovation, including integration of telemedicine and other technologies.
Innovative psychedelic programmingKetamine-Assisted Psychotherapy (KAP) for depression launched in Montreal and Vancouver, with ongoing development for other indications.
Psychedelic neurology and therapeutic protocols for MDMA and psilocybin in development.
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The strategy for acquisition Our target
Clinics that are profitable, growing and located in major metropolitan areas across Canada and the US.
Our offerA robust scaling platform, deep medical and scientific expertise, and proprietary strategies to integrate psychedelics into existing treatments like psychotherapy and neurology.
Our differentiatorWidely recognized by peers for our commitment to accessibility, collaboration and innovation — strengthening our position with potential targets.
May 2020Listed on TSX-V with $6M financing
Jun 2020Licence amended to grow & extract Psilocybe mushrooms
Sep 2020$4.6M financing
Jan 2020Acquired Bioscience lab
Jan 2021Upgraded lab with industry-leading analytical equipment
Dec 2020Announced MDMA- assisted therapy trial
Dec 2020Submitted formal briefing note to Health Canada for major psychedelic regulation change
Dec 2020Acquired Montreal clinic
Jan 2021Signed lab services contract with Optimi
Dec 2020$17M financing
Dec 2020Completed Canada’s first Psilocybe extraction by a pubco
Oct 2020Completed Canada’s first Psilocybe harvest by a pubco
Nov 2020Announced psilocybin-assisted psychotherapy trial
Feb 2021Announced major milestones in MDMA trial
Mar 2021Significantly amended lab licence to expand R&D capabilities
Mar 2021Announced lab expansion plans and $1.2M investment in state-of-the-art equipment
Mar 2021$40M financing
Apr 2021 Announced Phase 1 trial for natural psilocybin extraction
May 2021 Hired key leaders in business development, M&A, market research and marketing
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Milestones to date
June 2021 Uplisted to TSXV Tier 1
June 2021 Filed patent application for psilocybin rapid production process
July 2021 Announced Toronto clinic acquisition
July 2021 Received Health Canada approval for MDMA trial
June 2019Acquired Vancouver clinic
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Stock ticker symbols TSX.V: NUMI (Canada)OTC: LKYSF (United States)
Market capitalization Approximately $197M
Total shares outstanding 202,986,513
Warrants outstanding 40,642,856
Options outstanding 11,617,722
Fully diluted shares outstanding 255,247,091
Average daily volume traded TSX.V: 1,050,000OTC: 454,000
Cash position $63.2M
FIGURES AS OF JULY 29, 2021. All figures noted are in Canadian dollars.
Capitalization table
The path forward22
Developing products, protocols and processes to advance accessible research, treatment and systemic change.
Thoughtful growth strategy to bring Numinus to communities in Canada, US and beyond.
Continuous clinical innovation to deliver best-in-class treatments.
Engaging regulators, researchers, peers and the public to drive education and reform.
Scientific and medical innovation
Expansion of clinic network
Transformative patient experience
Thought leadership and awareness building
#801 - 33 Water Street,Vancouver, B.C. V6B 1R4numinuswellness.com
Jamie Kokoska VP of Investor Relationsjamie.kokoska@numinus.ca
KCSA Strategic CommunicationsAllison Soss / Annie GrafNuminus@KCSA.com
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