P111889 - InMed · 2020. 2. 11. · 7 The Opportunity for Biosynthesis • InMed initiated the biosynthesis program over five years ago to ensure access to a supply of rare cannabinoids

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 PresentationFebruary 2020

www.inmedpharma.com :IN :IMLFF

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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 of Canada. As a result, it may be difficult for investors to enforce civil liabilities under United States federal or state securities laws.

Disclaimers

Investor Presentation Feb 2020

http://www.sedar.com/

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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 or circumstances occurring after the date hereof, except as required by law.

Forward Looking Statements


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A Differentiated Cannabinoid Pharmaceutical Company

Focused on the Therapeutic Application of Cannabinoids for the Treatment of Diseases with High Unmet Medical Needs

Researching the therapeutic potential of rare cannabinoids, beyond THC & CBD, beginning with cannabinol (CBN)

Developing a biosynthetic manufacturing approach that targets low cost production of bio-identical cannabinoids for internal and external commercial needs

Selecting innovative, topically applied cannabinoid therapies where we can establish a proprietary foothold in treating diseases with high unmet medical needs


5Note: lists are not exhaustive

The Opportunity & Challenge of Rare Cannabinoids

100+ Rare Cannabinoids2–20%<1%

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…

• The 100+ rare cannabinoids occur in extremely low amounts in the cannabis plant

• The cost of extracting sufficient quantities of these cannabinoids can be prohibitive

• The challenge is how to manufacture sufficient quantity & purity to investigate, and potentially commercialize, rare cannabinoid-based therapies


Proprietary Biosynthesis Process


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The Opportunity for Biosynthesis

• InMed initiated the biosynthesis program over five years ago to ensure access to a supply of rare cannabinoids that is reasonably priced and ultra-high quality (pharmaceutical-grade).

• Valuable technology, not only to our own therapeutic development programs, but possibly as a licensor and supplier of rare and/or major cannabinoids for other pharmaceutical development programs and retail commercial opportunities.

Enabling internal access to rare cannabinoids…

… and expanding the commercial opportunities for the others


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Cannabinoid Manufacturing Alternatives

Extraction from Plants Chemical Synthesis

Biosynthesis• 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 cannabinoids prohibitively expensive

• Expensive for some, time consuming (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 CMC

Structural Integrity Advantage for some CBs


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Biosynthesis: Completed R&D

2015–2017 2018 2019

Determined hostsystem bacteria vs yeast

Identified genetic elements needed to upregulate substrate concentration for cannabinoid

production in E. coli

Finalized plasmid design for cannabinoid production in E. coli

Demonstrated target cannabinoid(s) production at

laboratory scale

Upstream Tech Transfer

Downstream Process Development

Alternative Process Development

FILING OF KEY PATENTS


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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/CDMO #2

Conduct alternative process studiesCDMO #2

Decision on future manufacturing pathway

Scale-up of alternative process CDMO #2

PCT application filing

Conduct GMP analytical assays development and process development to support batch production

Initiate GMP batch production at CDMO (if needed)

Completed In Progress


11Note: lists are not exhaustive

Biosynthesis: Competitive Landscape

Bacteria Yeast Algae/Other

• InMed proprietary, flexible manufacturing pathways

• Technically challenging butmore cost effective for pharma-grade active pharmaceutical ingredient (API)

• Complicated IP landscape

• Technically easier but less cost effective for pharma-grade API

• Unproven scale-up process for pharma-grade API

K E Y PA R T N E RS H I P S

R&D Commercial


InMed’s Therapeutic Pipeline


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API in Lead Product Candidates: INM-755 (dermatology) & INM-088 (ocular)

Cannabinol (CBN) – InMed’s First Rare Cannabinoid API

• A rare cannabinoid with unique physiological and safety properties

• A natural compound, but qualifies as a new chemical entity (NCE) for pharmaceutical development

• Considered non-psychoactive

• Found in trace amounts in the plant; impractical to extract

• InMed preclinical studies show therapeutic potential for dermatology and ocular diseases

Cannabinol (CBN)


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InMed is the Leader in CBN Therapeutic Development

• InMed is first to advance CBN into a clinical trial as a therapeutic agent

• Conducted 30+ preclinical pharmacology and toxicology studies

• No observed psychoactivity*:

• No adverse events on central nervous system (CNS) function from assessment of 108 aspects of behavior posture, gait, and movement

* Based on internal preclinical in vitro & in vivo studies

INM-755 cream for EB

CBN only cannabinoid to upregulate keratin 15 compared to other cannabinoids, including CBD

INM-088 eye drops for glaucoma

CBN demonstrated best neuroprotection compared to several cannabinoids, including THC and CBD


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Epidermolysis Bullosa

• 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 or scratching

• 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 integrity

Photograph of Dystrophic EB


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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 Potential Symptomatic 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


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INM-755: Pharmacology (based on CBN preclinical studies)

● CBN-mediated reduction of key inflammatory markers (IL-8 & MMP-9) suggests INM-755 may:

o reduce blistering if applied to intact skin

o reduce chronic wound occurrence and improve healing when applied directly

● INM-755 upregulation of Keratin 15 may offset Keratin 14 dysfunction, leading to increased skin integrity/strength and fewer blisters

● INM-755 may have potential pain-relief* effects

* Wong et. al, 2019 “Cannabidiol, cannabinol and their combinations act as peripheral analgesics”Investor Presentation Feb 2020

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INM-755: Toxicology & Safety

● INM-755 API (CBN) demonstrated safety:

o 20+ toxicology and safety studies: no safety concerns

o Topical and systemic safety established at several orders of magnitude above expected exposure

• 383-fold margin of safety for topical treatment

• 10,000-fold margin of safety for expected systemic exposure after topical dosing

● INM-755 highly unlikely to produce psychoactivity or other CNS toxicity:

o 108 aspects of behavior and movement were assessed, with no adverse effects on CNS, even at 10,000 times the expected systemic exposure after topical dosing

o CBN showed no meaningful psychoactivity in independent research studies at exceptionally large IV doses*

● Cream formulation without CBN:

o well tolerated on intact skin and small open wounds in humans

o no interference/delay in wound healing*Perez-Reyes M. et. al. A comparison of the pharmacological activity in man of IV administered THC, CBN and CBD. Experientia 29/11; p 1368-69. 1973. Investor Presentation Feb 2020

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INM-755: Summary of Contemplated Clinical Trials

Initiate / Treat 4Q19–3Q20In Netherlands

File 4Q20 Global

TBDGlobal

Phase I755-101-HV

Phase I755-102-HV Phase I/II Phase II

Enrollment ~22 healthy volunteers ~8 healthyvolunteers

12-15 EB patients (all subtypes)

TBD, EB patients(all subtypes)

MaskingDouble blind,

vehicle controlledDouble blind,



vehicle controlled

Primary PurposeSystemic and local

safety/PKLocal safety

Systemic and local safety, efficacy

Efficacy and safety

Treatment and Duration14 days on intact skin;

two strengths

7+ 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


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INM-755: High-Level Time/Event Schedule

1H 2019

Selected single cannabinoid for INM-755

Contracted 12 additional preclinical safety studies

Selected EU clinical site for Phase 1 healthy volunteer studies

Chose site in the Netherlands for expedited CTA review

Selected 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

Enrollment in755-101-HV

Complete patient treatment in755-101-HV

File CTA in the Netherlands for 755-102-HV

Initiate Phase 1 Trial 755-102-HV

Enrollment in755-102-HV

Report Results from 755-101-HV

Complete patient treatment in 755-102-HV (July)

Report Results from 755-102-HV

Prepare & file global regulatory submissions for 755-202-EB trial (4Q)

Additional guidance on second indication to be provided



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PH 1 755-101-

HV

EB

New Skin Indications

Preclinical Toxicology

PH 1 755-102-

HV

Ph 1-2 755-201-EB

Ph 2

InMed Therapeutics Pipeline – Dermatological Diseases

1H211H20 2H204Q19 2H21

RegulatoryPreparation

INM-755

PoC Preclinical Trials


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Target Effects of CBN

INM-088: Potential for CBN in Glaucoma

• Provide direct neuroprotection for the retinal ganglion cells (RGCs) and other optic nerve tissues in the affected eyes

• Reduce the IOP in the affected eyes

• Build up of fluid causes intra-ocular pressure (IOP) to increase

• Millions of nerve fibers that run from retina to the optic nerve are damaged due to increased IOP


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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

Complete formulation development and PoCanimal studies

Convert provisional patent to PCT; file for other indications (TBD)

Initiate IND/CTA enabling tox studies

Additional guidanceto be provided in 1H20



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1H211H20 2H204Q19 2H21

InMed Therapeutics Pipeline – Ocular Diseases

Ph 1IND-enabling

Toxicology Studies

Additional Ocular

IndicationsAdditional Preclinical Proof-of-Concept for Neuroprotection

Testing Delivery Technology

Advanced Proof-of-Concept Studies

AdvancedIn VivoStudies

Pre-IND Mtg.

(if needed)

Glaucoma

INM-088


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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)

• Cannabinoid-based therapy for Glaucoma (Prov 2019)

• Hydrogel formulation (PCT 2018)

• Bi-Functional enzyme to upregulate precursor / substrate for CB (PCT 2018)

• Expression of CB synthases in E. coli (Prov 2019)

• Precursor upregulation of CB in E. coli (Prov 2019)

• Alternative enzyme to mediate CB synthesis (Prov 2019)

• 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; also, pediatric voucher)


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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, Pre-clinical R&D

20+ years of engineering, scale-up and GMP manufacturing experience with Phyton Biotech, Arbutus Biopharma, 3M and Cardiome Pharma

19+ years of scientific leadership experience with enGene in gene transfer technologies, formulation and process development


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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 papers holds 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 from the MIT


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Board of Directors

William Garner, MDFounder of EGB

Ventures LLC (Chairman)

Andrew HullFormer VP of Global Alliances at Takeda

Pharmaceuticals

Eric A. AdamsPresident and CEO of

InMed Pharmaceuticals

• 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

• 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 of 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.


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Financial Snapshot

:IMLFF :IN

Previous Close (2020-02-03) US$0.268 C$0.34

52-week High US$0.627 C$0.80

52-week Low US$0.165 C$0.215

Avg. Volume (Daily; Trailing 3 Month) 277,600 191,116

Market Cap, I/O (2020-02-03) US$43.4M C$58.6M

Shares I/O 172.3M

Options/Warrants* 19.36M/17.7M

Fully Diluted Shares (2019-12-31) 209.36M

Cash Equivalents and Short-term InvestmentsC$14.8 (US$11.2) millionat September 30, 2019

*Warrants expire June 2020; weighted average price of $1.24Investor Presentation Feb 2020

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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 Others…


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

mailto:[email protected]

mailto:[email protected]

Documents

P111889 - InMed · 2020. 2. 11. · 7 The Opportunity for Biosynthesis • InMed initiated the biosynthesis program over five years ago to ensure access to a supply of rare cannabinoids