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U N L O C K I N G T H E P O T E N T I A L O F C A N N A B I N O I D M E D I C I N E S
Investor PresentationMay 2020
www.inmedpharma.com :IN :IMLFF
This presentation does not constitute an offering to sell or a solicitation of an offer to buy securities and the information contained herein is subject to the information contained in the Company’s continuous disclosure documents on SEDAR at www.sedar.com.
Information concerning the assets and operations of the Company included in this presentation has been prepared in accordance with Canadian standards and is not comparable in all respects to similar information for United States companies. In addition, any financial information included in this presentation has been prepared in Canadian dollars, except as otherwise indicated, and is subject to applicable Canadian generally accepted accounting principles and Canadian auditing and auditor independence standards, which differ from United States generally accepted accounting principles and United States auditing and auditor independence standards in certain material respects.
The information provided in this presentation is not intended to provide financial, tax, legal or accounting advice.
The Company exists under the laws of the Province of British Columbia, Canada. A substantial portion of the Company’s assets are located outside the United States. As well, some of the Company’s officers and directors are residents ofCanada. As a result, it may be difficult for investors to enforce civil liabilities under United States federal or state securities laws.
Investor Presentation Ma 2020y2
Disclaimers
This presentation contains forward-looking statements and forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) including, among others, statements concerning: unlocking the full potential of cannabinoid pharmaceuticals; anticipated clinical development activities, timelines, catalysts, and milestones; the potential benefits of product candidates; anticipated revenue and market opportunities; and the continued availability of key personnel. All statements other than statements of historical fact are statements that could be deemed forward-looking statements.
With respect to the forward-looking information contained in this presentation, the Company has made numerous assumptions regarding, among other things: continued and timely positive preclinical and clinical efficacy data; the speed of regulatory approvals; demand for the Company’s products; continued availability of key personnel; continued access to sufficient capital to fund operations; and continued economic and market stability.
These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and other factors 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; key personnel may become unable to serve the Company; the need for receipt of regulatory approvals; and economic and market conditions may worsen. Readers are cautioned that the foregoing list is not exhaustive. A more complete discussion of the risks and uncertainties facing the Company appears in the Company’s annual information form dated September 26, 2019, a copy of which is available on SEDAR at www.sedar.com.
The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events orcircumstances occurring after the date hereof, except as required by law.
Investor Presentation Ma 2020y3
Forward Looking Statements
A Differentiated Cannabinoid Pharmaceutical Company
Focused on the Therapeutic Application of Cannabinoids for the Treatment of Diseases with High Unmet Medical Need
Researching the therapeutic potential of rare cannabinoids, beyond THC & CBD, beginning with cannabinol (CBN)
Selecting innovative, topically applied cannabinoid therapies where we can establish a proprietary foothold in treating diseases with high unmet medical needs
Developing a biosynthetic manufacturing approach that targets low cost production of bio-identical cannabinoids for internal and potential external commercial needs
4
Investor Presentation Ma 2020y
5Note: lists are not exhaustive
The Opportunity & Challenge of Rare Cannabinoids
100+ Rare Cannabinoids<1% 2–20%
Major Cannabinoids
THC CBD
• Epilepsy
• Anxiety
• Stress Disorder
• Pain
• Inflammation
• Nausea
• Stress Disorder
• Sleep Apnea
CBN, CBG, CBGA, CBGV, CBGVA, THCV, THCVA,CBC, CBCV, CBCVA, CBDV, CBC, CBCA, CBNA…
• 100+ rare cannabinoids occur in extremely low amounts in the cannabis plant
• Cost of extracting sufficient quantities ofthese cannabinoids can be prohibitive
• Challenge is how to manufacture sufficient quantity & purity to test and commercialize, rare cannabinoid-based therapies
Investor Presentation Ma 2020y
Cannabinoid Manufacturing Alternatives
Extraction from Plants Chemical SynthesisBiosynthesis• Plant – Grow – Harvest – Extract
– Purify process is resource intensive, large carbon footprint, QA/QC issues
• Expensive, takes months for a single production batch
• Pesticide removal is challenging, may result in import/export restrictions
• Access to rare cannabinoidsprohibitively expensive
• Expensive for some, timeconsuming (weeks) for all
• Excessive chemical waste
• Problem of isomers (structural integrity) for some CBs that may affect efficacy/safety; risk that synthesized product may not be identical to the natural compounds
Bio-identical to Extracts
Cost Savings for Rare CBs
Enhanced Purity and QC
Pharma-grade CMCStructural Integrity
Advantage for some CBsFor Therapeutic & other
Commercial useInvestor Presentation Ma 2020y
6
Biosynthesis: Completed R&D
2015–2017 2018 2019
Determined host system bacteria vs yeast
Identified genetic elementsneeded to upregulate substrateconcentration for cannabinoid
production in E. coli
Finalized plasmid design forcannabinoid production in E. coli
Demonstrated target cannabinoid(s) production at
laboratory scale
Upstream Tech Transfer
(Fermentation)
Downstream Process Development (Purification)
Alternative ProcessDevelopment with Almac Group
FILING OF KEY PATENTS
Investor Presentation May 20207
8
USP – Up-stream Process (Fermentation); DSP – Down-stream Process (Purification); GMP – Good Manufacturing Practices; NRC – National Research Council of Canada; CDMO – Contract Development and Manufacturing Organization
Biosynthesis: High-level Time & Event Schedule
1H 2019
HPLC assay tech transfer to NRC
Up-stream fermentation tech transfer to NRC
Small scale bioreactor fermentation condition optimization (on-going)
Filing of additional patent applications
2H 2019 1H 2020 2H 2020
Finalize USP development at NRC
DSP development at CDMO #1/Almac
Conduct alternative process studiesAlmac
Decision on future manufacturing pathway
PCT application filing
Scale-up of alternative process with Almac
Conduct analytical assays development and process development to support batch production
Initiate GMP batch production at Almac (if needed)
Investor Presentation May 2020
Completed In Progress
Note: lists are not exhaustive
Biosynthesis: Competitive Landscape
Yeast
• Complicated IP landscape• Technically easier but less cost
effective for pharma-grade API
Bacteria
• Technically challenging but more cost effective for pharma-grade active pharmaceutical ingredient (API)
• InMed proprietary, flexible manufacturing pathways
Algae/Other
• Unproven scale-up process forpharma-grade API
K E Y PA RT N E RS H IP S
R&D Commercial
9Investor Presentation May 2020
InMed is the Leader in Cannabinol (CBN) Therapeutic Development
Investor Presentation Ma 2020y10
API in Lead Product Candidates: INM-755 (dermatology) & INM-088 (ocular)• A rare cannabinoid with unique physiological and safety properties• Found in trace amounts in the plant; impractical to extract• InMed conducted 30+ preclinical pharmacology and toxicology studies• Generally considered non-psychoactive
• No adverse events on central nervous system (CNS) function from assessment of 108 aspects of behavior posture, gait, and movement Cannabinol (CBN)
INM-755 cream for EBCBN is the only cannabinoid to upregulate
keratin 15, including CBD
INM-088 eye drops for glaucomaCBN demonstrated superior
neuroprotection compared to several cannabinoids, including THC and CBD
* Based on internal preclinical in vitro & in vivo studies
Epidermolysis Bullosa
11
• Epidermolysis bullosa (EB) is a group of genetic conditions that cause the skin to be very fragile and to blister/rupture easily in response to minor injury or friction, such as rubbing orscratching
• The most common form is EB Simplex (EBS),approximately 55% of all EB patients
• No approved treatments specific to EB; treatment involves many products
• INM-755 being investigated for both symptomatic relief and re-establishing skin integrityPhotograph of Dystrophic EB
Investor Presentation May 2020
INM-755 for Epidermolysis Bullosa
Targeting Disease Hallmarks in All EB Patients
Further Evaluate Ability to Strengthen Skin in a Subset of EBS Patients
Being Investigated to Deliver PotentialSymptomatic Relief:
• Reduce Inflammation
• Healing of chronic wounds
• Pain reduction
Other potential effects of cannabinoids:
• Itch reduction
• Antimicrobial Activity
Dermal/ Epidermal Junction
Dermis
Epidermis
Blister
EB Simplex: K14 malformations
12Investor Presentation May 2020
INM-755: 30+ Pharmacology, Toxicology & Safety Studies
● CBN-mediated reduction of key inflammatory markers (IL-8 & MMP-9)suggests INM-755 may:o Reduce incidence and/or severity of blistering if applied to intact skino Improve healing when applied directly to chronic wound
● INM-755 upregulation of Keratin 15 may offset Keratin 14 dysfunction in EBS, leading to increased skin integrity/strength and fewer blisters
13
● INM-755 API (CBN) demonstrated safety:o 20+ toxicology and safety studies: no safety concerns
● INM-755 highly unlikely to produce psychoactivity or other CNS toxicity:o no adverse effects on CNS, even at 10,000 times expected systemic exposure after topical dosing
● Cream formulation without CBN:o well tolerated on intact skin and small open wounds in humans
Investor Presentation May 2020
14
INM-755: Summary of Contemplated Clinical Trials
Initiate / Treat 4Q19–3Q20In Netherlands
File 4Q20 / 1Q21 Global
TBDGlobal
Phase I755-101-HV
Phase I755-102-HV
Phase I/II755-201-EB
Phase II755-202-EB
Enrollment 22 healthy volunteers 8 healthyvolunteers
12-15 EB patients (all subtypes)
TBD, EB patients(all subtypes)
Masking Double blind, vehicle controlled
Double blind, vehicle controlled
Double blind, vehicle controlled
Double blind, vehicle controlled
Primary Purpose Systemic and local safety/PK Local safety Systemic and local
safety, efficacy Efficacy and safety
Treatment and Duration 14 days on intact skin; two strengths
14 days on small wounds; two strengths
1 month on intact skin and maybe wounds;
two strengths
3 months on intact skin and maybe wounds; maybe two strengths
Efficacy Endpoints None None All efficacy parameters All efficacy parameters
Notes Adults only Adults onlyAdults (~3), then
adolescents (~3), then children 2+yrs
Adults, adolescents, children
Investor Presentation May 2020
15
INM-755: High-Level Time/Event Schedule
1H 2019
Selected single cannabinoid for INM-755Contracted 12 additional preclinical safety studiesSelected EU clinical site for Phase 1 healthy volunteer studiesChose site in the Netherlands for expedited CTA reviewSelected cream manufacturer in EU
2H 2019 1H 2020 2H 2020
Completed CTA-enabling toxicology program
Completed product manufacturing for Ph 1
Wrote Investigator’s Brochure and CMC summary for CTA
Filed CTA in the Netherlands; CTA approved
Initiated Phase 1 Trial 755-101-HV
Corporate sponsor at EB World Congress
Complete enrollment in755-101-HV
File CTA in the Netherlands for 755-102-HV
Complete patient treatment in755-101-HV
Initiate Phase 1 Trial 755-102-HV
Compete enrollment in755-102-HV
Report Results from 755-101-HV
Complete patient treatment in 755-102-HV
Report Results from 755-102-HV
Prepare & file global regulatory submissions for 755-201-EB trial (4Q20 – 1Q21)
Investor Presentation May 2020
Completed In Progress
INM-088: Potential for CBN in Glaucoma
Target Effects of CBN
• Provide direct neuroprotection for the retinal ganglion cells (RGCs) and other optic nerve tissues
• Reduce the IOP in the affected eyes
• Build up of fluid causes intra-ocular pressure (IOP) to increase
16
• Millions of nerve fibers that run from retina to the optic nerve are damaged due to increased IOP
Investor Presentation May 2020
17
INM-088: High-Level Time/Event Schedule
1H 2019
File provisional patent for neuroprotection in the eye
Complete selection of API
Select appropriate pharmacodynamic model to evaluate neuroprotection in Glaucoma / other disease models
2H 2019 1H 2020 2H 2020
Initiate / complete preliminary preclinical neuroprotection studies
Convert provisional patent to PCT; file for other indications (TBD)
Conduct additional PoC preclinical studies (if needed)
Complete formulation data analysis & select preferred delivery technology
Initiate IND/CTA enabling toxicology studies
Investor Presentation May 2020
Completed In Progress
18
Intellectual Property Portfolio and Commercial Exclusivity
INM-755(EB)
INM-088(Glaucoma) Biosynthesis
• A method of treating EBS with cannabinoid or mixture of cannabinoids topically to upregulate keratin expression (PCT 2017)
• Topical formulations of CBs and their use in treatment of pain (PCT 2018)
• Cannabinoid-based therapy for Glaucoma - Neuroprotection (PCT 2019)
• Hydrogel formulation (PCT 2018)
• Bi-Functional enzyme to upregulate precursor / substrate for CB (PCT 2018)
• Enhancing Transport of Aromatic Substrates (PCT 2020)
• Precursor upregulation and expression of CB in E. coli (PCT 2020)
• Potential additional commercial protection through orphan disease designation (e.g. EB, +7-10 yrs.), pediatric indication (+6-24 mo.) and new chemical entity (+5 yrs.)
• Potential additional opportunities to accelerate clinical development & regulatory review (e.g. FDA “Breakthrough”, “Fast-Track” and/or “Priority Review” status, pediatric voucher)
Investor Presentation May 2020
Key Upcoming Milestones*
Biosynthesis INM-755 for EB INM-088 for Glaucoma
• Initiate Phase 1 Trial 755-102-HV
• Report Results from 755-101-HV
• Complete patient treatment in 755-102-HV
• Report Results from 755-102-HV
• Prepare & file global regulatorysubmissions for 755-201-EB trial (4Q20 – 1Q21)
• Scale-up of alternative process at Almac
• Conduct analytical assays development and process development to support batch production
• Initiate GMP batch production at CDMO (if needed)
• Complete formulation data analysis & select preferred delivery technology
• Conduct additional PoCpreclinical studies (if needed)
• Initiate IND/CTA enabling toxicology studies
• Additional guidance to be provided in 2H20
Investor Presentation May 202019
* Latest best estimates. InMed is in frequent communication with our vendors and collaborators to monitor the COVID-19 situation and ‘return-to-work’ guidelines. Updates will be provided on a regular basis.
Eric A. Adams, MIBSChief Executive Officer
Bruce S. Colwill, CPA, CAChief Financial Officer
Alexandra Mancini, MScSVP, Clinical and Regulatory Affairs
30+ years of experience in global biopharma leadership: business development, sales, marketing, and M&A with enGene, QLT, Abbott, Fresenius
25+ years of financial leadership with private and public companies; executing IPO, equity and debt financings General Fusion, Entrée Resources, Neuromed Pharma
30+ years of global biopharma R&D experience, overseeing drug development with Sirius Genomics, Inex Pharmaceuticals, and QLT
Experienced Executive Team
Michael Woudenberg, PEngVice President, CMC
Eric Hsu, PhDSVP, Preclinical R&D
20+ years of engineering, scale-up and GMP manufacturing experience with Phyton Biotech, Arbutus Biopharma, 3M and Cardiome Pharma
20+ years of scientific leadership experience with enGene in gene transfer technologies, formulation and process development
Investor Presentation May 2020 20
Board of Directors
William Garner, MDFounder of EGB
Ventures LLC (Chairman)
Andrew HullFormer VP of GlobalAlliances at TakedaPharmaceuticals
Eric A. AdamsPresident and CEO of
InMed Pharmaceuticals
• 25+ years’ experience as biotech entrepreneur
• Chairman/Founder of Race Oncology (ASX:RAC). Formerly Director+/- Executive atIGXBio; Invion Limited; Del Mar; Hoffmann LaRoche and healthcare merchant banking
• 30+ years’ pharma/biotech commercial leadership experience
• Previously in various leadership roles with Immunex and Abbott Laboratories. Former two-term Chairman of Illinois Biotech Industry Organization
• 30+ years’ experience in global biopharma leadership
• Business development, sales, marketing, and M&A with InMed, enGene, QLT, Abbott, Fresenius
Adam CutlerCFO at Molecular
Templates, Inc.
• 20+ years’ experience in Equity Research, Corporate Affairs and Strategy, IR
• Formerly with Trout Group, Credit Suisse, Canaccord Genuity, JMP Securities, BoA Securities, E&Y Healthcare Consulting
Catherine SazdanoffJD, Healthcare Industry
Board Member and Consultant
• 35+ years’ experience including global leadership in corporate development, BD, legal and other areas
• Roles with Abbott Labs, Takeda Pharma, and Strata Oncology. Director, Meridian Biosciences, Inc.
21Investor Presentation May 2020
Scientific Advisory Board
Mauro Maccarrone, PhD Steven Dinh, ScD Vikramaditya G. Yadav, PhD
• Prof. and Chair, Biochemistry & Molecular Biology at Campus Bio-Medico, University of Rome
• Former President, International Cannabinoid Research Society and recipient of their 2016 Mechoulam Award
• Founding member of the European Cannabinoid Research Alliance
• Authored 460 published papersholds eight issued patents
• Dr. Dinh has 30+ years of industry experience, which has resulted in 60+ patent publications, 6 NDA approvals and the successful commercialization of 9 products
• Fellow of the American Association of Pharmaceutical Scientists and of the American Institute for Medical and Biological Engineering
• Doctoral degree from MIT
• Asst. Prof., Department of Chemical & Biological Engineering and School of Biomedical Engineering, UBC
• Serves as the Chair of the Biotechnology Division, Chemical Institute of Canada
• Recognized by Medicine Maker as one of the 100 most influential people in drug development / manufacturing
• PhD in Chemical Engineering fromthe MIT
22Investor Presentation May 2020
Financial Snapshot
:IMLFF :IN
Previous Close (2020-05-11) US$0.179 C$0.25
52-week High US$0.380 C$0.470
52-week Low US$0.108 C$0.170
Avg. Volume (Daily; Trailing 3 Month) 310,833 173,038
Market Cap, I/O (2020-05-11) US$29.6M C$43.1M
*Warrants expire June 2020; weighted average price of $1.2423
Shares I/O 172.3M
Options/Warrants* 19.36M/17.7M
Fully Diluted Shares (2019-12-31) 209.36M
Cash Equivalents and Short-term Investments C$12 (US$9) million at December 31, 2019
Investor Presentation May 2020
InMed at a Glance
Diverse pipeline across a
spectrum of diseases with high unmet
medical needs
Robust, innovative and
disruptive biosynthesis
manufacturing technology
World class leadership with successful track record in drug development
Multiple significant
catalysts and milestones
Building a Technologically Advanced Cannabinoid Pharmaceutical Company Unlike Any Other…
24Investor Presentation May 2020
Thank You!
Eric A. AdamsChief Executive Officer
[email protected]+1-604-669-7207
Bruce S. ColwillChief Financial Officer
[email protected]+1-604-669-7207
:IN :IMLFFwww.inmedpharma.com