FIVE pharmaceuticals.
25
august 2020 presentation FIVE pharmaceuticals.
Transcript of FIVE pharmaceuticals.
august 2020 presentation
FIVE pharmaceuticals.
fivepharma
fivedisclaimer
page02
This document contains proprietary and confidential information. All data submitted to partners, associates or persons operating on behalf of, or with FIVE Pharmaceuticals Labs Ltd., is provided in
reliance upon its consent not to use or disclose any information contained herein, except in the context of promotional and/or licensing activities officially sanctioned by FIVE Pharmaceuticals Labs
Ltd. The recipient of this document agrees to inform its present and future employees and associates who view or have access to this document of its confidential nature.
The recipient agrees to instruct each employee or relevant persons that they must not disclose any information concerning this document to other except to the extent of such matters that are
generally known to, and available for use by the general public. The recipient also agrees to not directly or indirectly duplicate or distribute any material contained herein without the expressed
permission and written consent of FIVE Pharmaceuticals Labs Ltd.FIVE Pharmaceuticals Labs Ltd. retains all title, ownership and intellectual property to the materials
and contained herein, including all supporting documentation, files, and marketing material. All information in this document was provided for and approved by FIVE Pharmaceuticals Labs Ltd.
BY ACCEPTANCE OF THIS DOCUMENT THE RECIPIENT AGREES TO BE LEGALLY BOUND BY THE AFOREMENTIONED STATEMENT
fivepharma
presentationagenda
page03
our productshowcase
who we are
our businessoffer
fivepharma
fivepharmaceuticals
page04
FIVE’s mission is to be the first to market publicly traded Canadian pharmaceutical Psilocybin Company specializing in R&D and Clinical Trials to help patients with PTSD, depression, drug addictions and mental health disorders in first responders and Veterans through Health Canada licensing with Good Manufacturing Practices (GMP) and ISO 9001 standards.
The brand FIVE Pharmaceuticals represents our focus to the FIVE key controlled substances Psilocybin, DMT, Ayahuasca, Ketamine and MDMA under our FIVE corporate branches Sciences, Pharmaceuticals, Labs, Research and Clinical Trials.
who we are
fivepharma
corporatestatements
page05
our licensed missionFIVE pharmaceuticals will be Health Canada authorized under section 56(1) of the controlled substances exemptions for R&D and Clinical Trials for Psilocybin and section 9 dealer license to handle, package and re-sale of commercial controlled substances across Canada.
our verified strategyFIVE will be operating under ISO 9001 and GMP compliance in order to serve our pharmaceutical partners to full Health Canada standards producing a commercially viable product ready for re-sale and distribution. By building out FIVE’s relationship with Health Canada’s licensing office, we will be positioned to aid andfacilitate our dealers license process.
our organic visionThrough R&D and Clinical Trial programs, FIVE aims to showcase benefits of extracted organic compounds over single molecule synthetic products. We will be conducting side by side Clinical Trials demonstrating the benefits of organic compounds derived from organic substances and formulated with superior delivery systems are typically more effective with multiple narcotic market comparables.
fivepharma
canada’s healthlandscape
page06
Number of Canadians who will be affected by mental health
issues by the age of 40
50%
Estimated annual economic burden of mental illness in
Canada
$51b
Of PTSD patients are not receptive to current traditional
treatments
9%
Of Canadians have reported experiencing a traumatic event reshaping their mental health
76%
4thOf Canadians suffer from
PTSD at least once in their lifespan
Canada’s worldwide rank per capita in anti-depressant drug
usage
8%
Number of Canadians who suffer from addiction in any
given year
20% 9thLeading cause of deaths
nationwide are attributed to suicide with an average of 11
per day
https://www150.statcan.gc.ca/n1/daily-quotidien/200527/dq200527b-eng.htmhttps://www.camh.ca/en/driving-change/the-crisis-is-real/mental-health-statisticshttps://www.canada.ca/en/health-canada.html
fivepharma
global problems& solutions
page07
FIVE IS THE SOLUTION FIVE Pharmaceuticals' goal is to be a leader on a global scale assisting the masses with PTSD, Depression, Drug Addiction and Mental Health Disorders. Novel psychedelic related compounds will be the next wave of drug discovery.
Post-Traumatic Stress Disorder (PTSD)An estimated 351 million people have PTSD in the world today
DEPRESSIONAn estimated 254 million people are battling depression globally today
MENTAL HEALTH DISORDERS450 million people suffer from Mental Health Disorders on a global scale
OPIOID DRUG ADDICTIONOver 27 million people have opioid addiction problems on planet earth
01
02
03
04
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394282/https://www.who.int/news-room/fact-sheets/detail/depressionhttps://www.who.int/substance_abuse/information-sheet/en/https://www.who.int/whr/2001/media_centre/press_release/en/
GLOBAL MARKETOver 1 billion people in the world suffer from PTSD, Depression, Opioid Addiction and Mental Health Disorders and Psilocybin can help tackle these global health issues.
OPIOID27 millionPTSD
351 million
DEPRESSION254 million
MHD450 million
fivepharma
meet ourmanagement
page09
tyler powellCEO15 years of entrepreneur and finance experience with over 10 Companies taken public on Canadian, US and German exchanges raising tens of millions in corporate financings through different channels along the way. CEO and founder of go public merging vehicle Murdo Acquisitions Corp.
dr. orion lekosCSOOrion Lekos, PhDChief Science Officercompleted clinical trials on a global scale including PTSD, Depression, Opioids, Cannabis and pain management for chemotherapy cancer treatments. Helped develop, design and build Tilray’s extraction and formulations.
arron victoryCSOArron will provide strategic guidance on establishing FIVE Pharmaceuticals as the gold standard in evidence based psychedelic treatment therapies for the Canadian veteran and first responder communities, in accordance with all Health Canada regulations. Currently Arron holds a seat on the Chronic Pain Center of Excellence advisory board and is an ambassador for Wounded Warriors Canada.
dr. peter tomlinsonCMODr. Tomlinson MBA is a world-wide consultant that specializes in supporting North American pharmaceutical and biotechnology companies in transitioning new products into early clinical trials. Worked with industry leading companies such as Taro, Tilray, Supratek and Sandoz.
fivepharma
meet ouradvisors
page010
dr. phillipe henrygeneticsOne of Canada's foremost cannabis geneticists, Dr. Henry is a former professor of evolutionary genetics and has led numerous scientific initiatives in the cannabis industry.
denis silvalegal councilPartner at DLA Piper Vancouver’s office with expertise in corporate corporate finance and mergers and acquisitions. Prior to Piper, Mr. Silva was senior legal council with the BCSC.
john karrollhealth CanadaOf Trichome Consulting Services a global licensing expert that has completed one third of all Canadian Cannabinoid licenses with a long successful track record with Health Canada.
dylan rekertmarketingFounder and lead VP of creative of the Very Polite marketing Company. Creative visionary behind Canada’s most innovative brands such as Hootsuite, Kit and Ace and the Fairmont Hotels.
arthur kwanfund managerInvestment banking, capital markets, and private equity experience. Has held senior investment banking positions with Scotia Capital, Peters & Co., and PI Financial, as Managing Director of Investment Banking.
dr. emmanouil rampakakisCROExtensive knowledge of clinical trial research and strong acumen for client service and relationship management to successfully lead and foster BioPharma’s Global Business Development unit
fivepharma
licensingbreakdown
page011
01 Pre-CTA meetingFIVE has acquired the services of InnomarStrategies working hand in hand with Dr.Lekos and Dr. Tomlinson to book pre-clinical trial meeting with Health Canada
04 Dealers licenseUpcoming application to become a section 9 dealer’s license holder to produce and market the product of the R&D and clinical stages
02 R&D licensePending application for a section 56(1)exemption to use controlled substances for scientific purposes (Psilocybin)
05 Future licensingFuture R&D and clinical trials applications for 56(1) exemption for additional therapeutic compounds including Ketamine, MDMA, DMT and Ayahuasca
03 Clinical Trials licensePending application for a section 56(1)exemption to use controlled substances for clinical trials (Psilocybin)
06 Health Canada securityConstruction build out of secured lab to Health Canada’s security level 9 including surveillance systems and vault
fivepharma
3 phasecompartments
page012
Dr. Lekos manages this compartment by applying for and achieving a section 56(1) exemption R&D license with Health Canada and heads the research, genetics and will extract alkaloids including Psilocin from Psilocybin to conduct Clinical Trials. Dr. Tomlinson will engage as the secondary authority for the review of this application approval process.
Dr. Tomlinson manages this compartment by by obtaining section 56(1) exemption Clinical Trials license with Health Canada and being team leader handling all business related with Clinical Trials with help from our third-party partnership Clinical Research Organization (CRO) JSS Medical Research with SGS Canada assistance.
Our in-house pharmacist and his assistant manages this compartment applying for and achieving a section 9 commercial re-sale license to sell IP formulations and genetic products to other licensed Companies across Canada. Dr. Lekos will assist our pharmacist with the Health Canada licensing and support all submitted paperwork.
RESEARCH &DEVELOPMENT
CLINICAL TRIALS
COMMERCIAL RE-SALE
fivepharma
path torevenue
page013
01 licensingapplications for Section 56(1) exemptions and section 9 for R&D, clinical trials and commercial re-sale with Health Canada
03 extraction & formulationorganic and synthetic production of Psilocybin products and IP formulations for re-sale and internal use
02 clinical trailscollection of data and medical analyses of Veterans and first responders suffering from PTSD and depression
04 medical psilocybin FIVE working with MD’s and wellness clinics to supply Canadians with medical grade IP formulated products approved by Health Canada and GMP standards
fivepharma
veteran research &clinical trials
page014
Veteran Focused ResearchPartner with established public and government research organizations in the Canadian Veteran stakeholder community to further identify how Veterans and first responders can benefit from psychedelic compound treatment from an evidence-based perspective. There are currently roughly 172,000 Veterans in Canada suffering from PTSD illnesses seeking relief with comprehensive Blue Cross coverage.
The Team at FIVE Pharmaceuticals has created a use of proceeds fund for donations to the top tier non-profit Veteran focused organizations in Canada.
Dr. Lekos and Dr. Tomlinson along with SGS and our Clinical Research Organizations (CROs) will administer the micro-dosing human clinical trials using Dr. Lekos’ proprietary delivery system across multiple locations in Canada. FIVE’s phase II ceiling is to administer 8 human clinical trials across Canada with Veterans and First Responders in year 1 using the following scheduling:
20 patients per trial2 hour sessions3 sessions a week5 week duration
FIVE Pharma has engaged Innomar Strategies to execute a pre-CTA meeting with Health Canada.
Clinical Trials
fivepharma
licensingtimelines
page015*Above minimum timelines are verified by Health Canada’s Licensing office
70days from date of submittal to
approval
Health Canada approval for Research & Development with
Psilocybin products under Section 56 exemption
45days from date of submittal to
approval
Health Canada approval for Clinical Trials in the Psilocybin
Sector under Section 56(1) exemption
90Days until
production of organic cultures
FIVE will be producing product in house for trials, research and
re-sale to other licensed purchasers. Commercial re-
sale needs an approved Section 9 license
All below times will be run in parallel
fivepharma
security& GMP
page016
Health Canada securityUnder Health Canada Controlled Substance act, the dollar amount of controlled substances that can be held under our licensed premise depends on our security clearance level. Currently, Health Canada has illicit Psilocybin priced at $25,000 per kilogram and the current North American GMP market for a gram of pure synthetic psilocybin is $10,000. For FIVE to comfortably navigate these exuberant product costs safely, a security level of 8-9 would allow the Company to house between $3,000,000 and $31,000,000 worth of controlled substances covering a multitude of compounds covered under section 56(1) and section 9 for future business ventures.
The FIVE pharmaceutical team currently has working arrangements with SGS Canada to build its R&D lab facility to GMP standards for food grade, C-GMP, ISO 9001 and future pharmaceutical EU-GMP grade for cultivation, packaging and resale. SGS will supervise all license filings and audits on a yearly schedule moving forward.
Our founder Dr. Tomlinson has successfully achieved pharmaceutical EU-GMP certification with Tilray Pharmaceuticals and will be lead engineer of this compartment.
GMP and ISO 9001 standards
fivepharma
construction &GMP timeline
page017
30 Days60 Days
90 Days
2 Months12 Months
14 Months
Phase 3Health Canada security surveillance systems including integrated vault
GMP TIMELINE
C-GMPDr. Tomlinson manages audit with SGS Canada to achieve pharmaceutical Canadian GMP
EU-GMPAchieve EU-GMP compliance in order to facilitate trade with EU member states
Phase 2GMP standard interior, supporting lab spaces and equipment install
Phase 1Epoxy floor, wall upgrades and GMP standard exterior skeleton build
CONSTRUCTION TIMELINE
Food Grade GMPFood grade audit and application to be submitted post construction completion by SGS Canada
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/international/mutual-recognition-agreements/updates/mutual-recognition-agreement-canada-european-community.html
fivepharma
intellectualproperty
page018
GENETIC REGISTRATION & RIGHTS
FIVE Pharmaceuticals intellectual property development plan revolves around a quantified composition, new use, and invention claims approach. We combine these aspects together in order to bolster our claims to best suit strong and robust patent protection, specifically in organic molecular formulations.
There is an incredible opportunity for developing and securing intellectual property in the Psilocybin and Psychedelic space. FIVE Pharmaceuticals is working hand in hand with our IP/patent counsel at Cooley LLP and BLG identifying the targets hosting the most opportunity to protect and to affectively capitalize on.
five pharma.
fivepharma
project timeline 2020-2021
page019
phase 1 – planning
phase 2 – lab construction
phase 3 – clinical trials
aug sept oct nov dec jan feb mar apr may jun jul
06/20 08/20
08/20
10/20
Planning and construction of 6,000 square foot GMP standard
lab facility in Burnaby, BC.
planning90 day build out of exterior,
interior and supporting lab space with equipment order and install.
constructionBegin of synthetic baseline and
organic formulation Phase II human clinical trials with our
CRO in Toronto, On.
clinical trials
05/21
10/20
fivepharma
partners &associates
page020
SGS CanadaThe world’s leading inspection,
verification, testing and certification company
Innomar StrategiesPre-CTA Health Canada
specialist handling FIVE’s literature dive for clinical trials
Aspen MedicalCanadian Wellness Centers working directly with FIVE’s
formulations and product delivery
TriChomeHealth Canada licensing specialist consulting firm
DLA PiperWorld largest and leading legal firm managing the go public route for FIVE
AlthoTechEU-GMP certification expert consulting outfit
fivepharma
marketcomparisons
page021
MINDMED
18-MC therapy for treatment of opioid use disorder,18-MC is derived from Ibogaine with offices in Vancouver, BC
01
MYDECINE
a publicly traded life sciences parent company dedicated to the development and production of adaptive pathway medicine solutions.
02
CHAMPIGNON
A clinic and drug development company based out of Kelowna, BC with several acquisitions to date
03
COMPASS
Psilocybin therapy for treatment-resistant depression, In-clinic supervision required, based in London, UK
04
$110mm $76mm $50mm $450mm* market valuations as of August 1st, 2020 prices in CAD
fivepharma
privateproject cost
page022
expense cost
lab build $650,000
security $100,000
GMP licensing $250,000
lease & working cap $500,000clinical trials $1,000,000
total* $2,500,000
* not including pubco audit, legal, marketing costs
fivepharma
financingopportunity
page023
5,000,000 shares available with half warrant at $0.20
Secures lab location to begin lab construction, GMP build out and integrated licensing for R&D and Clinical Trials
Proceeds: $500,000
I $0.101st tranche
5,000,000 shares available with full warrant at $1.00
Phase 2 Clinical Trials using IP formulation, new controlled substance licensing applications and pubco marketing and working capital funded and secured
Proceeds: $2,500,000
I $0.503rd tranche
8,000,000 shares available with full warrant at $0.50
Completes lab build out with Health Canada security level 9 to begin Psilocybin cultivation, extraction and IP formulation
Proceeds: $2,000,000
I $0.25IPO - 2nd tranche
Murdo Acquisitions has 1,896,500 shares I/O including distribution
Three rounds of financing 18,000,000 shares
5,000,000 founder shares @0.10
I/O: 24,896,500 + warrants Proceeds: $5,000,000 + warrants
I share structureIssued and outstanding (I/O)
fivepharma
ourcontacts
page024
address
suite 400, 110 cambie street
Vancouver, BC V6B 2M8
currently acquiring:
13351 Commerce Parkway
Richmond, BC V6V 3A1
phone
ceo 1-778-994-8050
online
fivepharmaceuticals.com
facebook/fivepharmaceuticals
twitter/fivepharmaceuticals
Instagram/fivepharmaceuticals
Linkedin/fivepharmaceuticals
email/[email protected]
thank you.
the five pharmaceuticals team
