Presentation 2021 1 - Apex Labs
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Title
Presentation
20211Disclaimer
This document contains proprietary and confidential information. All data submitted to partners, associates or
persons operating on behalf of, or with APEX 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 APEX 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 APEX Labs Ltd.
APEX 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 APEX Labs Ltd.
BY ACCEPTANCE OF THIS DOCUMENT THE RECIPIENT AGREES TO BE LEGALLY BOUND BY THE AFOREMENTIONED STATEMENT
2Who
Title We Are
Over 1 billion people suffer
fromsome form of compromised
mental health.
APEX’s objective is to be the first Canadian publicly traded listed neuro-
pharmaceutical company working with psychedelic molecules that show
promise to develop solutions for patients with PTSD, depression, drug addiction
and other related mental health disorders. APEX Labs’ Canadian clinical
development program is focused on the veteran community and first responders,
groups who are most affected by these disorders. The Company’s lead clinical
candidate is a synthetic psilocin for the treatment of PTSD. Our activities are
compliant with Health Canada requirements for the handling of controlled drugs and
international pharmaceutical standards for the development and commercialization of
our products.
3Corporate Statements
Mission Vision Strategy
Under the controlled drug and substances act Through R&D and Clinical Trial programs, APEX will be operating under GMP
to execute R&D and clinical development of APEX aims to showcase the benefits of compliance in order to serve our
controlled drugs such as psilocin and psilocybin extracted organic compounds and single pharmaceutical partners to full Health
through Section 56(1) exemption. In addition, molecule synthetic products. Canada standards producing a
a section 9 dealer’s license will allow APEX to We will be conducting side by side commercially viable product ready for
possess, produce, package and sell controlled Clinical Trials demonstrating the re-sale and distribution. By building
drug pharmaceutical products across Canada. high level of efficacy of our organic out APEX’s relationship with Health
compounds which are formulated to Canada’s licensing office, we will be
APEX expects to be the first company to have superior delivery systems that make positioned to aid and facilitate our
execute a Canadian Phase II clinical trial using them more successful than multiple dealers license process.
psilocin (the active metabolite of psilocybin) narcotic market contenders.
directly.
4Canada’s Health Landscape
Leading cause of deaths nationwide
Estimated annual
economic burden of
9 th are attributed to suicide with an
$51B mental illness in Canada
average of 11 per day
20%
Number of Canadians
Number of Canadians who suffer who will be affected by
from addiction in any given year 50% mental health issues by
4 th the age of 40
76%
Canada’s worldwide
rank per capita in 9%
anti-depressant Of Canadians suffer
drug usage Of Canadians have reported Of PTSD patients 8% from PTSD at least
experiencing a traumatic event once in their lifespan
are not receptive to
reshaping their mental health current traditional
treatments 5Global Problems & Solutions
APEX is The Answer
Our organic compound formulations,
which are derived from organic
substances, have a higher efficacy in
treating mental health disorders than
MHD 450 million PTSD 351 million
any single molecule synthetic product.
APEX’s goal is to be the global leader in assisting
a wide spectrum of patients dealing with PTSD,
Depression, Drug Addiction and Mental Health
Disorders. We know that novel psychedelic related
compounds will be the next wave of drug discovery
and we will lead the way in R&D and Clinical Trials
involving these compounds.
Opioid 27 million Depression 254 million
6Global Problems
1 MHD 450 million 2 PTSD 351 million
Over 450 million people suffer from Mental Health Disorders An estimated 351 million people are living with PTSD in the
on a global scale, with an estimated $51b of annual economic world today. 8% of Canadians will suffer from PTSD at least
impact within Canada alone. 50% of Canadians will be affected once in their lives.
by mental health issues by the age of 40, while 76% of all
Canadians having reported experiencing a traumatic event 9% of PTSD patients are not receptive to current traditional
reshaping their mental health. treatments.
3 Opioid 27 million 4 Depression 254 million
Today it’s estimated over 27 million people have opioid An estimated 254 million people are battling depression globally
addiction problems globally. 20% of Canadians suffer today. Canada is ranked 4th in anti-depressant drug usage per
from addiction in any given year. capital with suicide as a result of depression being the leading
cause of deaths nationwide.
7Management
Tyler Powell CEO Dr. Orion Lekos CSO
Mr. Powell is an entrepreneur with 15 years Our Chief Science Officer, Dr. Lekos, has
of experience in the financial sector. He participated and led global clinical trials
has led the IPO for multiple companies on on PTSD, Depression, Opioids, Cannabis
the Canadian, US and German exchanges, and pain management for chemotherapy
raising tens of millions in corporate cancer treatments. Dr. Lekos has
financings through several channels facilitated the development, design
along the way. He is the CEO and founder and build of numerous extractions and
of the go-public vehicle called Murdo formulations for Tilray - a large Canadian
Acquisitions Corp. pharmaceutical company with operations
in Australia, New Zealand, Germany,
Portugal and Latin America.
8Management Cont.
Dr. Peter Tomlinson CMO Alex Winstead CCO Mirza Rahimani CPA, CA CFO
Dr. Tomlinson is a highly sought out Alex Winstead is a top North American Over twelve years of experience working
consultant and a prominent industry mycologist and mushroom cultivator with with early and development stage
leader, who specializes in supporting over 16 years experience in the gourmet companies, primarily in the context of
pharmaceutical and biotechnology and medicinal mushroom industry. His going or being public. Mr. Rahimani has
companies in the process of transitioning company, Cascadia Mushrooms LLC of served as a director and officer of TSX-V
new products into early clinical trials and Bellingham, Washington, is where Alex listed public companies and been involved
commercialization. He has partnered with and his team grow thousands of pounds in RTO, IPO, and other public company
leading companies across the globe, such of Certified Organic mushrooms every related transactions. He is a Chartered
as such as Tilray, Aegera Therapeutics, week. Their efforts supply a variety of Professional Accountant, and has earned
Purgenesis, Ultragenyx, Sharp, Taro and markets with raw products for medicinal a Bachelor of Commerce from the
Supratek. extraction and supplement formulation University of British Columbia.
across the U.S. as well as fresh gourmet
mushrooms to local and wholesale outlets
throughout the region.
9Advisors
Dr. David Wood IP & Regulatory Law Denis Silva Legal Council
Dr. Wood is a trail blazing leader with patents, IP, regulatory Mr. Silva is Partner at DLA Piper Vancouver’s office with expertise in
and licensing consultation in the psychedelic space as partner corporate finance, mergers and acquisitions. Prior to Piper, Mr. Silva
of BLG Law Calgary with a PhD in BioChemistry. was a senior legal council with the BCSC.
John Karroll Health Canada Arthur Kwan Fund Manager
Mr. Karroll, currently leading Trichome Consulting Services, Mr. Kwan has an extensive investment banking, capital markets, and
is a global licensing expert who has completed one third of private equity experience. He has held senior investment banking
all Canadian Cannabinoid licenses. He has a long and very positions with Scotia Capital, Peters & Co., and PI Financial as
successful track record with Health Canada. Managing Director of Investment Banking.
Dr. Emmanouil Rampakakis CRO Arron Victory Veteran Affairs
Dr. Rampakakis has an extensive knowledge of clinical Mr. Victory will provide strategic guidance on establishing
trial research with a strong acumen for client service and APEX Labs Ltd. as the gold standard in evidence based psychedelic
relationship management. He currently leads BioPharma’s treatment therapies for the Canadian veteran and first responder
Global Business Development unit. communities, in accordance with all Health Canada regulations.
10Protocols
1 Pre-CTA Meeting APEX has acquired the services of Innomar Strategies working hand in hand with
Dr. Lekos and Dr. Tomlinson to book pre-clinical trial meeting with Health Canada.
Pending application for a section 56(1) exemption to use controlled substances
2 R&D License for scientific purposes.
Pending application for a section 56(1) exemption to use controlled substances
3 Clinical Trials License for clinical development purposes (Psilocybin/Psilocin).
Upcoming application to become a Dealer’s License holder to produce and market
4 Dealers License the product used for the R&D and Clinical stages.
Construction build out of secured lab to Health Canada’s security level 9
5 Health Canada Security including surveillance systems and vault.
113 Phase Approach
Research 2 Clinical Commercial
1 & Development Trials
3 Re-Sale
Dr. Lekos manages this compartment Dr. Tomlinson manages this APEX’s SPIC, QA, assistant QA,
by applying for and achieving a section compartment by obtaining section pharmacist and pharmacist assistant
56(1) exemption R&D license with Health 56(1) exemption Clinical Trials license manages this compartment after
Canada and heads the research, genetics with Health Canada and being team achieving a section 9 dealer’s license
and will extract alkaloids including Psilocin leader handling all business related to and GMP certification for commercial re-
from Psilocybin to conduct Clinical Clinical Trials with help from our third- sale to sell IP formulations and genetic
Trials. Dr. Tomlinson will engage as the party partnership Clinical Research products to other licensed Companies
secondary authority for the review of this Organization (CRO) JSS Medical across Canada. APEX has a joint venture
application approval process. Research with SGS Canada assistance. with Aspen Island Therapeutics to supply
any controlled substances needed for
their new psychedelic wellness initiative
including APEX’s IP formulations.
12Path to Revenue
1 2 3 4
Licensing Extraction & Clinical Medical
Clinical trails applications Formulation Trials Psychedelics
for Section 56(1) Organic and synthetic production Collection of data and medical APEX’s working with MD’s
exemptions and section 9 of Psilocybin and Psilocin analyses of Veterans and first and wellness clinics to supply
for R&D, clinical trials and and patent protected responders suffering from PTSD, Canadians with Health
commercial re-sale with Formulations for re-sale and traumatic brain injuries and Canada approved
Health Canada. internal use. chronic pain. pharmaceutical drug
products based on patent
protected delivery systems.
13Veteran Focused Research
APEX will partner 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 tens of thousands of Canadian veterans suffering from chronic
conditions, who seek relief with comprehensive Blue Cross coverage.
We are committed to making a difference.
APEX Labs Ltd. veteran focused research team will be focusing on
PTSD, traumatic brain injuries and chronic pain in the Canadian veteran
community. We believe in a whole person approach to recovery for
veterans and first responders who suffer from chronic service related
conditions.
14Clinical Trials
APEX Labs Ltd. is currently in pre-CTA discussions with Health Canada.
The New Gold Standard.
The APEX team has developed a protocol for a veteran focused Phase
II clinical trials emphasized on PTSD and chronic pain in Fall 2020 with
a schedule date pending Health Canada’s comments under a pre-CTA
review. APEX has sourced GMP API and drug product manufacturing to
facilitate our first trials and R&D in 2021. Under the review of Dr. Lekos, Dr.
Tomlinson and Dr. Rampakakis APEX is set to be the new gold standard
in Canadian psychedelic clinical trials.
15Licensing Timelines
All phases described below will run in parallel
Health Canada approval for Clinical Trials in the Psilocybin
Clinical Trials Day 60
Sector under Section 56(1) exemption.
Health Canada approval for Research & Development
Research & Development Day 70 with Psilocybin products under Section 56 exemption.
APEX will be producing API GMP psilocin product through
Production Day 90 Dalton Pharma for trials, research and re-sale to other
licensed purchasers with the goal of creating organic
compounds in-house once licensed.
16Security & GMP
Health Canada Security GMP & ISO 9001 Standards
Under Health Canada Controlled Substance act, the dollar The APEX Labs Ltd. team currently has working
amount of controlled substances that can be held under arrangements with SGS Canada to build its R&D lab
our licensed premise depends on our security clearance facility to GMP standards and pharmaceutical EU-GMP
level. Currently, Health Canada has illicit Psilocybin priced grade for cultivation, packaging and resale. SGS will
at $25,000 per kilogram and the current North American supervise all license filings and audits on a yearly schedule
GMP market for a gram of pure synthetic psilocybin moving forward.
is $10,000. For APEX to comfortably navigate these
exuberant product costs safely, a security level of 8-9 Our founder Dr. Tomlinson has successfully achieved
would allow the Company to house up to $31,000,000 pharmaceutical GMP certification with Tilray
worth of controlled substances covering a multitude of Pharmaceuticals and will be lead engineer of
compounds covered under section 56(1) and section 9 for this compartment.
future business ventures.
*all numbers in CAD
17Intellectual Property
Genetic Registration & Rights
APEX Labs Ltd. 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. APEX Labs Ltd. 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.
18Project Timeline 2021
Planning and construction of
1 Planning 2,200 square foot GMP standard 01/21 - 04/21
lab facility in Richmond, BC.
120 day build out of exterior,
2
Lab interior and supporting lab space 03/21 - 06/21
Construction with equipment order and install.
Begin of synthetic baseline
and organic formulation Phase II
3 Clinical Trials human clinical trials with our
Starting
05/21
CRO in Montreal, QC.
19Partners & Associates
Innomar Strategies Aspen Island
Pre-CTA Health Canada Canadian Wellness Centers working
specialist handling APEX’s directly with APEX’s formulations and
literature dive for clinical trials. product delivery.
Mykology
Extraction,
formulation and
DLA Piper genetics specialist
World largest and leading legal
firm managing the go public
route for APEX. BLG Law
Canada’s largest law
AlthoTech firm handling APEX’s
TriChome Canadian IP.
GMP certification Health Canada licensing
expert consulting JSS Medicao
specialist consulting firm. Research
outfit. SGS Canada
The world’s Clinical Research
Cascadia Mushrooms Dalton Pharma leading inspection, Organization
Pacific North-West leading Pharmaceutical cGMP verification, testing (CRO) handling
organic cultivation. Manufacturing Lab. and certification clinical trials and
company. protocols.
20Market Comparisons
1 MINDMED $1.65b 4 COMPASS $2.22b
18-MC therapy for treatment of opioid use disorder, 18-M is Psilocybin therapy for treatment resistant depression, In-clinic
derived from Ibogaine with offices in Vancouver, BC. supervision required, based in London, UK.
2 FIELD TRIP $339mm 5 NUMI $298mm
Field Trip blends legal psychedelic-enhanced therapy, Numinus is a mental health company creating an ecosystem of
mindfulness, and self-care with a series of sessions with trained health solutions to research, develop, and deliver safe, evidence
psychotherapists in a spa-like environment. based, accessible psychedelic-assisted psychotherapy.
3 MYDECINE $92mm 6 CYBIN $275mm
A publicly traded life sciences parent company dedicated to Cybin is a leading biotechnology company focused on
the development and production of adaptive pathway medicine progressing psychedelic therapeutics by utilizing proprietary
solutions. drug discovery platforms.
* MARKET VALUATIONS AS OF FEBRUARY 14TH, 2021. PRICES IN CAD. 21Private Project Cost - 18 Month Runway
Expense Cost
Lab Build $1,500,000
Security $100,000
Product Sourcing $300,000
Lease & Working Cap $500,000
Clinical Trials $1,500,000
Total $3,900,000
22Financing Opportunity
Proceeds
5,000,000 shares available Secures lab location to begin lab construction, GMP build
1 $0.10 1 tranche
st
$500,000
* Near complete with full warrant at $0.20 out and integrated licensing for R&D and Clinical Trials
12,000,000 shares available Completes lab build out with Health Canada security level 9
2 $0.25 IPO $3,000,000
2nd tranche with full warrant at $0.50 to begin Psilocybin cultivation, extraction and IP formulation
Phase 2 Clinical Trials using IP formulation, new controlled
6,000,000 shares available
3 $0.50 3rd tranche substance licensing applications and pubco marketing and $3,000,000
with full warrant at $1.00
working capital funded and secured
Murdo Acquisitions has I/O: 30,896,500
Share Structure 1,896,500 shares I/O
Three rounds of financing 6,000,000 founder
Issued & Outstanding (I/O) 18,000,000 shares shares $6,500,000
including distribution
+ warrants
* Numbers are not final and may be subject to change.
23Contact
Name Apex Labs Ltd.
Address Suite 400 - 110 Cambie Street, Vancouver, BC V6B 2M8
Aquired 13351 Commerce Parkway, Richmond, BC V6V 3A1
Phone (778) 994-8050
Email tyler@apexlabsltd.com
24Thank You
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