Presentation 2021 1 - Apex Labs
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Title Presentation 20211
Disclaimer 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 2
Who 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. 3
Corporate 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. 4
Canada’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 5
Global 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 6
Global 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. 7
Management Tyler Powell CEO Dr. Peter Tomlinson CMO Mr. Powell is an entrepreneur with 15 years of experience in Dr. Tomlinson is a highly sought out consultant and a prominent the financial sector. He has led the IPO for multiple companies industry leader, who specializes in supporting pharmaceutical and on the Canadian, US and German exchanges, raising tens biotechnology companies in the process of transitioning new products of millions in corporate financings through several channels into early clinical trials and commercialization. He has partnered with along the way. He is the CEO and founder of the go-public leading companies across the globe, such as such as Tilray, Aegera vehicle called Murdo Acquisitions Corp. Therapeutics, Purgenesis, Ultragenyx, Sharp, Taro and Supratek. Dr. Orion Lekos CSO Alex Winstead CCO Our Chief Science Officer, Dr. Lekos, has participated and led Alex Winstead is a top North American mycologist and mushroom global clinical trials on PTSD, Depression, Opioids, Cannabis cultivator with over 16 years experience in the gourmet and medicinal and pain management for chemotherapy cancer treatments. mushroom industry. His company, Cascadia Mushrooms LLC of Dr. Lekos has facilitated the development, design and build Bellingham, Washington, is where Alex and his team grow thousands of numerous extractions and formulations for Tilray - a of pounds of Certified Organic mushrooms every week. Their efforts large Canadian pharmaceutical company with operations in supply a variety of markets with raw products for medicinal extraction Australia, New Zealand, Germany, Portugal and Latin America. and supplement formulation across the U.S. as well as fresh gourmet mushrooms to local and wholesale outlets throughout the region. 8
Advisors 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. 9
Protocols 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. 10
3 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. 11
Path 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. 12
Veteran 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. 13
Clinical 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. 14
Licensing 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. 15
Security & 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 16
Intellectual 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. 17
Project 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. 18
Partners & 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. 19
Market 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. 20
Private 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 21
Financing 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. 22
Contact 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 23
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