CORPORATE PRESENTATION - Home | InMed ... LOOKING STATEMENTS This presentation contains...
Transcript of CORPORATE PRESENTATION - Home | InMed ... LOOKING STATEMENTS This presentation contains...
FORWARD LOOKING STATEMENTS
This presentation contains forward-looking statements, including statements concerning anticipated clinical development activities, the potential benefits of product candidates and anticipated market opportunities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements.
These risks and uncertainties include, among others, the possibility that clinical trials will not be successful, or be completed, or confirm earlier clinical trial results, risks associated with obtaining funding from third parties, risks related to the timing and costs of clinical trials and the receipt of regulatory approvals. Readers are cautioned that the foregoing list is not exhaustive. For additional information with respect to risks and uncertainties, prospective investors should carefully review and consider the risk factors described under the section “Risk Factors” in the Company’s annual information form dated November 15, 2017, a copy of which is available on SEDAR at www.sedar.com and under the section “Risk Factors” in the short form prospectus. The company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof.
CSE:IN OTCQB:IMLFF2
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OVERVIEW
InMed is a publicly listed, Vancouver-based biopharmaceutical company focused on identifying, developing and commercializing prescription cannabinoid drugs.
Core AssetsBioinformatics PlatformProprietary computer-based drug/disease targeting process
BiosynthesisProprietary manufacturing process for all 90+ cannabinoids
Drug Development PipelineCreating novel, non-THC, topically applied cannabinoid pharmaceuticals to treat diseases with high unmet medical needs, including:
➢ INM-750 for Epidermolysis Bullosa – An orphan disease characterized by extremely fragile skin. Potential global market revenues of ~US$1B per year.
➢ INM-085 for Glaucoma – A serious eye disease with a global market of >US$5B.
➢ INM-405 for Pain – Targeting topical administration. Total market >US$36B in 2017.
e
The endocannabinoid receptor system isa group of endogenous cannabinoidreceptors located in the mammalianbrain, throughout the central andperipheral nervous systems, and intissues and organs.
This system is predisposed tointeract with members ofthe cannabinoid drug family.
HEALING POWER OFCANNABINOIDS
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90+ IndividualCannabinoid Compounds
THC
CBD
+8
80+ Cannabinoids
EACH HAS A POTENTIAL THERAPEUTIC ROLE INTHE HUMAN BODY
EndocannabinoidReceptor System
BIOINFORMATICS:Drug/Disease Targeting Platform
InMed’s bioinformatics platform assesses the various active sites on cannabinoids and screens them against approved drug structures, disease site receptors, geneticprofiles of diseases, and the involvement of proteins and chemical metabolites in disease pathways.
This process leads to the selection of specific cannabinoids (or combinations thereof) that might play a role in regulating various diseases.
Advantages of InMed’s Bioinformatics Platform
➢ Generates new therapeutic targets both quickly and effectively - significant cost and time savings in the drug discovery process.
➢ Allows InMed to research pharmacological responses of ALL 90+ cannabinoids.➢ Has already identified multiple therapies including INM-750, INM-085 & INM-405.
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DRUG DEVELOPMENT:
Lead Therapeutic Programs
(estimated timelines)
* Timelines dependant on, among other things, availability of capital. ** Potential partnership / spin-out opportunities.
Therapeutic Area DiscoveryTarget
SelectionPre-Clinical, Formulation
Clinical Trials
Ph1 Ph2 Ph3
Dermatology INM-750 (Epidermolysis bullosa)
2017*
2018* *
**
Ocular INM-085 (Glaucoma)
* ***
***
***
Pain ProgramINM-405(TMD)
* * **
**
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EPIDERMOLYSIS BULLOSA
INM-750
No approved treatments for EB
InMed’s lead product, INM-750 has many mechanisms-of-action in the skin to deliver symptomatic relief:
➢ accelerated wound healing ➢ pain reduction ➢ itch reduction➢ reduce inflammation➢ antimicrobial activity
INM-750 may re-establish the epidermal / dermal junction by upregulation of specific keratins in the skin, essentially reversing the disease.
~50K patients in N. America,Europe and Japan
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Potential Disease Reversal with INM-750
Other Key Data for INM-750: • Promotes the expression of K17 in HaCaT cells; • Promotes the expression of K6, K17 during differentiation whereas upregulating K15
expression at proliferation; • Up-regulates both basal K15 mRNA and protein expression by human keratinocytes.
Control INM-750
Ke
ratin
15
Exp
ressio
n ind
ex
Control INM-750 + IFNγ/TNFα
*
Keratin 15 (K15) is a type-1 keratin that may dimerize with K5 to re-establish the dermal-epidermal junction in K14 deficient EB patients.
INM-750 doesn’t change K15 expression in normal HaCaT cells but when the cells are challenged with IFNγ/TNFα - mimicking the inflammatory condition in EB patients – INM-750 upregulates K15 expression.
EPIDERMOLYSIS BULLOSA
Market Potential
Strategic Investments/Acquisition
➢ Scioderm was acquired by Amicus in 2015 for US$847M (US$229M upfront, remainder on milestones). Acquisition was based on results from 42 patients in a Ph2b study. Scioderm’s sole product targeted relief in 2 symptoms, with no impact on underlying disease.
➢ Lotus Tissue Repair acquired by Shire for US$174M (US$49M upfront; contingent of US$125M) for a pre-clinical program developing recombinant human collagen Type VII as a gene therapy protein replacement therapy for Dystrophic EB, ~30% of all EB patients. 9
Attractive Market Opportunity
➢ No approved therapies for EB➢ JP Morgan and Cowen research reports
estimate peak sales for symptom reduction in EB of US$900M - US$1.2B per year
>US$5B worldwide market~80M patients by 2020
GLAUCOMA:
INM-085
Serious Eye Disease Leading to Blindness
Dual Mechanism of Action➢ Reduces the intraocular pressure
(IOP) in the affected eyes; and
➢ Provide neuroprotection for the retinal ganglion cells (RGCs) and other optic nerve tissues in the affected eyes.
Proprietary Delivery System➢ INM-085 utilizes a 1x per day hydrogel
formulation to address the major issues of non-compliance (dosing frequency, side effects and adherence).
➢ Preclinical animal data showed enhanced penetration of cannabinoid molecules through the cornea and lens compared to control.
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Nanoparticle - Hydrogel Penetration Studies
• Composite hydrogel formulation achieved 3x higher drug penetration as compared to the control formulation.
• This study is the first to report direct drug uptake by the cornea and lens from a composite cannabinoid nanoparticle-hydrogel vehicle.
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INM-085 increases blood vessel diameter in pre-clinical mouse model
➢ Optical Coherence Tomography scan of a mouse retina (left untreated & right treated) showed an increase of blood vessel diameter after 30 min of application.
➢ Application of treatment in right eye didn’t effect the left, thus indicating local effect of INM-085 and not systemic.
➢ Increase blood vessel diameter is associated with lowering of IOP.
>US$36B worldwide marketfor all pain management drugs
PAIN MANAGEMENT:
INM-405
Local administration forPeripheral Pain Management
Temporomandibular Disorders (TMD)➢ Musculoskeletal and Neuromuscular (3)➢ TMJ, muscles and tissues➢ Mild to severe; 2x more women than men➢ 5-12% of total population➢ Treated with NSAIDS, anti-depressants
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Trigeminal Neuralgia (TN)➢ “The Suicide Pain”➢ Severe, electric shock pain at root ➢ ~18,000 in USA (up to possibly 20K)➢ Treated with surgical intervention,
opioids, anti-convulsants, BOTOXTM
Pain of the Trigeminal Nerve
Potential role of Cannabinoids in Pain
➢ CB1 / CB2 receptors are expressed by trigeminal ganglion neurons and in nerve endings in the masseter muscle.
➢ Peripheral application of certain cannabinoids reduce nerve impulses in the masseter muscle via CB1 receptors.
➢ Peripheral application of cannabinoids showed no central nervous system side effects.
➢ A specific combination of cannabinoids showed in vivo efficacy for treating peripheral pain.
CB1
CB2
InMed Research has demonstrated:
Above: CB1 and CB2 expression in masseter muscle nerves.Right: Increased pain (mechanical) threshold in mice treated with THC.
Ref: Wong, H. et al. Euro. J. Pain. June 2017.
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Robust Growth Potential
Therapeutic Area
Discovery / Disease Target
Selection
Target Validation (in vitro/vivo)
Formulation / Advanced Preclinical
ClinicalPh 1
Dermatology (Orphan)
- Epidermolysis Bullosa- Derm Disease 2- Derm Disease 3
**
2018*
Pain - Muscle Pain (TMD)
- Neuropathic Pain (TN)**
**
Ocular- Glaucoma * [Partner]
Fibrosis- COPD
TBD [Partner]
Neurodegenerative- Huntington’s
TBD [Partner]
Cancer- Breast Cancer
TBD [Partner]
INM-700 Series
INM-085
INM-400 Series
INM-300 Series
INM-100 Series
INM-200 Series
*Estimated timing dependent on, among other things, availability of capital.
BIOSYNTHESIS:
PROPRIETARY CANNABINOID MANUFACTURING
Cannabinoid Genomic DNA
Escherichia coli bacterium
Benefits of Biosynthesis
Enhanced Production, Purification and QC vs.
naturally-sourcedproducts
Significant cost savings vs. existing growing /
harvesting / extraction / purification methods
Access to minor cannabinoids that
are currently economically unfeasible to
develop into drugs
Increased structural integrity vs. chemical
manufacturing methods
Millions of diabetics worldwide use insulin produced via
E.coli biosynthesis.
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Industry-Disruptive Technology
Cannabinoid Manufacturing:
Current Methods
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Extraction from Plants ➢ Plant / Grow / Harvest / Extract / Purify process
is massively resource intensive, large carbon footprint, QA/QC issues
➢ Variations in cannabinoid content by strain➢ Expensive, takes months for a single production
batch➢ Pesticide removal is challenging, may result in
import/export restrictions➢ Access to minor cannabinoids prohibitively
expensive
Chemical Synthesis➢ Expensive, time consuming (weeks)➢ Excessive (toxic) waste➢ Problem of stereoisomers (structural integrity)
may affect efficacy/safety
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Biosynthesis – A Smart Approach
Insert biosynthetic
cluster into vector
Genome engineering
of host
Sugar
Product
Simple process, easy scale-up
Air
Straightforward purification
Microbe
Plant
CONFIDENTIAL
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BIOSYNTHESIS
Advantages & Opportunities
ADVANTAGES➢ Cost /time savings vs. existing cannabis plant-grow-harvest-
extract-purify ➢ Enhanced production, purification, quality control vs. agricultural
approaches, including avoidance of any impurities (e.g. pesticides)in the final product
➢ Increased structural integrity vs. other chemical (synthetic) manufacturing methods; bio-identical to the plant compounds and no risk of random/inactive isomer production
➢ Access to minor cannabinoids that are currently economicallyunfeasible to extract via plant sources or synthesize chemically
OPPORTUNITITESCannabinoid / Cannabis Opportunities➢ Medical Marijuana market estimated to be $12B in 2016; will surpass $55B by 2025 ➢ US Market for medical CBD alone estimated at >$2B in 2020 ➢ Pharmaceuticals, Nutraceuticals, MMJ, Recreational applications
Flavors and Fragrances➢ Terpenoids / Terpenes found in cannabis, such as limonene, pinene, myrcene,
caryophylene can be made using biosynthesis➢ F&F industry is expected to surpass $37B by 2021
KEY TEAMFOR BIOSYNTHESISPROGRAM
Dr. Sazzad Hossain Chief Scientific Officer, PhD, M.Sc. Extensive experience in pharmaceutical development of natural compounds with Canada’s National Research Council. Also involved in the biosynthesis program there.
Ben Paterson, P.E. Mr. Paterson was previously a Senior Engineering Advisor with Eli Lilly and Company, where he spent 37 years, including 24 years in their biosynthesis division. His expertise includes processes definition, scale-up (pilot and commercial).
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Dr. Vikram Yadav, Associate Professor, Department of Chemical & Biological Engineering at University of British Columbia (UBC). His research group specialize in metabolic & bioprocess engineering.
Dr. Protiva Roy, Research Scientist. PhD in Analytical Chemistry from Tokyo Institute of Technology, Japan and M.Scin Biochemistry from University of Dhaka, Bangladesh.
Dr. Sandip Pawar, Research Scientist. PhD in Bioprocess Technology from Institute of Chemical Technology, Mumbai and MSc on Pharmaceutical Technology from National Institute of Pharmaceutical Education & Research, India.
EXPERIENCED MANAGEMENT TEAM
Eric A. Adams CEO + President 25+ years’ experience in global biopharmaceutical leadership: business development, Sales, Marketing, M&A with enGene, QLT, Abbott Laboratories, Fresenius AG
Dr. Sazzad Hossain Chief Scientific Officer, PhD, M.Sc. 20+ years of academic/industry experience in drug discovery and product development at Xenon Pharmaceuticals, targeting pain, inflammation and cardiovascular diseases; and Canada’s National Research Council
Dr. Ado Muhammad Chief Medical Officer, MD, DPM, MFPM Former Associate Medical Director at GW Pharmaceuticals specializing in the development of cannabinoid-based prescription medicines
Alexandra Mancini Sr. Vice President, Clinical and Regulatory Affairs, M.Sc. 30 years’ global biopharmaceutical R&D experience with Sirius Genomics, Inex Pharmaceuticals, and QLT Inc.
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Jeff Charpentier Chief Financial Officer + Corporate Secretary25+ years’ experience in biotech and technology companies including Lifebank Corp., Inex Pharmaceuticals, and Chromos Molecular Systems Inc.
Andrew Hull, VP of Global Alliances at Takeda Pharmaceuticals30+ years’ pharma/biotech commercial leadership experience. Previously in various roles with Immunex and Abbott Labs. Two-term Chairman of Illinois Biotech Industry Organization.
Adam Cutler, CFO at Molecular Templates, Inc.20+ years of experience in Equity Research, Corporate Affairs and Strategy, Investor Relations and Consulting. Previously The Trout Group LLC, Credit Suisse, Canaccord Genuity, JMP Securities, BoA Securities, and The Frankel Group and E&Y Healthcare Consulting.
Martin Bott, VP Finance and Investment Banking at Eli Lilly & Company34+ experience in Finance, Investment Banking and Operations in the global pharmaceutical industry. Previous roles include CFO of Diabetes and Global Manufacturing Units; stints in CH, D, UK.
Eric A. Adams, President + CEO
BOARD OF DIRECTORS
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William Garner, MD Chairman Founder of EGB Advisors PR LLC Chairman/Founder of Race Oncology(ASX:RAC); Formerly Director +/-Executive at IGXBio; Invion Limited (ASX:IVX); Del Mar Pharma (NASDAQ: DMPI); Hoffmann LaRoche and healthcare merchant banking in NYC.
CAPITAL STRUCTURE
SymbolCSE: IN
OTCQB: IMLFF
Share I/O 1
Warrants 1
Options 1
Fully-Diluted 1
Market Capitalization 2
131.7 Million
7.1 Million
17.8 Million
156.6 Million 4
C$89.7 Million
1 As of November 10, 2017 2 As of November 10, 2017 on the CSE3 As of September 30, 2017 (Unaudited)4 Management, Founders & Insiders ~13% ownership
CSE:IN OTCQB:IMLFF
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Cash 3 C$6.0 Million
INVESTMENT HIGHLIGHTSBroad portfolio of assets in
dermatology, ocular diseases, pain, additional indications and cannabinoid
biosynthesis
Positioned to achieve value-driving, near-term milestones with limited investment:
➢ Lead drug candidate in a disease with high unmet medical need; final formulation development, toxicology and Ph1-2 clinical trials targeted for
completion within 24 months➢ Biosynthesis of cannabinoids in advanced commercial
scale-up in next 24 months
Experienced team capable of building value in biopharmaceuticals
CSE:IN OTCQB:IMLFF
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