UNLOCKINGTHEPOTENTIALOFCANNABINOIDMEDICINESfilecache.investorroom.com/mr5ircnw_inmedpharma/314...novel...

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

Company PresentationJuly 2020

www.inmedpharma.com :IN :IMLFF

http://www.inmedpharma.com/

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.

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Disclaimers

Company Presentation July 2020

http://www.sedar.com/

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.

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Forward Looking Statements


http://www.sedar.com/

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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, 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


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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 IntegraSynä - a flexible, integrated cannabinoid manufacturing system using novel enzyme(s) to efficiently produce bio-identical, economical, pharmaceutical-grade cannabinoids.

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


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Note: 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


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Limitations of Traditional Cannabinoid Production Approaches

• Bioburden/stress on microbe may limit final yields

• Separation and purification challenges to isolate cannabinoid from mixture

• Process costs / complexity increase with each new cannabinoid

• May not produce bio-identical cannabinoid depending on cannabinoid complexity

• Potential for significant yield loss due to purification / removal of the non-bio-identical cannabinoids

• Complicated and costly scale-up due to purification techniques

BIOSYNTHESISCHEMICAL SYNTHESIS

• Access to rare cannabinoidsprohibitively expensive

• Limited quantity in the plant• Plant > Grow > Harvest > Extract >

Purify process is resource intensive, large carbon footprint

• Much longer cycle time• Quality/consistency issues,

pesticide removal challenges may result in import/export restrictions

EXTRACTION


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IntegraSyn™ is InMed’s integrated cannabinoid manufacturing approach

IntegraSyn™: Biosynthesis Evolved

Minimizes bioburden on fermentation

microbe

Flexibility to shift from

production of one cannabinoid to a

range of cannabinoids

Optimized steps to produce high-yield,

pharma-grade cannabinoids

at commercial scale

Transferable technology

to facilitate scale-up, manufacturing

and supply

Commonly available and cost-efficient starting materials


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Cost-Efficient Cannabinoid Production with IntegraSynTM

E. coli Fermentation

Enzymatic Reaction

Upstream Processing Downstream Purification

Separation of Cannabinoid from Reaction Mixture

Enzyme

BIOSYNTHESIS

Crude Cannabinoid

MixtureDrying

BIOTRANSFORMATION

Further Cannabinoid Production

CHEMICAL SYNTHESIS

API Grade Cannabinoid

Path 1

Path 2

PURIFICATION

ORPath 1 or

Path 2

● Flexible

● Modular

● Cost-Efficient● Scalable


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Note: lists are not exhaustive

Cannabinoid Manufacturing: Competitive Landscape

IntegraSynTMYeast Biosynthesis Algae/Other

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

R&D Commercial

A flexible, integrated cannabinoid synthesis approach using a novel enzyme(s) and various standard

pharma manufacturing processes to efficiently produce bio-identical,

economical, GMP-grade cannabinoids.

Chemical Synthesis


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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

From Biosynthesis to IntegraSynTM: High-level Time & Event Schedule

2019

HPLC assay tech transfer to NRC

Up-stream fermentation tech transfer to NRC

Bioreactor fermentation condition optimization

Processing of patent applications

Finalize USP development at NRC

DSP development at Almac

Conduct alternative process studies at Almac

Decision on future manufacturing pathway

1H 2020 2H 2020

PCT application filed

Continue scale-up of IntegraSynTM process with Almac

Conduct analytical assay development to support batch production

Scale-up process to be GMP ready

Optimize pathways for production of other cannabinoids

Identify potential partnership opportunities

Completed Pending


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InMed is the Leader in Cannabinol (CBN) TherapeuticDevelopment

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• 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)

* Based on internal preclinical in vitro & in vivo studies

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


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Epidermolysis Bullosa

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• Epidermolysis bullosa (EB) is a group of rare genetic skin diseases characterized by fragile skin that blisters easily from minimal friction that causes shearing of the skin layers.

• The most common form is EB Simplex (EBS), ~55% of all EB patients.

• The affected population in the United States is estimated to be between 12,500 and 25,000 in the United States.

• No therapies approved specifically for the treatment of EB. Current treatment involves many products focused on symptoms and wound healing.

• INM-755 being investigated for both symptomatic relief and by enhancing skin integrity in subset of EBS patients.

Photograph of Dystrophic EB


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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

INM-755 for Epidermolysis Bullosa


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INM-755: 30+ Safety Pharmacology and Toxicology 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

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● INM-755 API (CBN) demonstrated preclinical safety:o 20+ toxicology and safety pharmacology studies: no safety concerns identified in

these studies for the intended application

● 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


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INM-755: Summary of Completed and Planned Clinical Studies, 2020-2021

Initiate / Treat 4Q19–3Q20In Netherlands

File CTAs in 4Q20/1Q21

Global

Phase I755-101-HV

Phase I755-102-HV

Phase I/II755-201-EB

Enrollment 22 healthy volunteers

8 healthyvolunteers

12-15 EB patients (all subtypes)

Masking 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

Treatment and Duration14 days on intact skin;

two strengths

14 days on small wounds; two strengths

1 month on intact skin and maybe wounds; two strengths

Efficacy Endpoints None None All efficacy parameters

Notes Adults only Adults onlyAdults (~3),

then adolescents (~3), then children 2+yrs


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INM-755: High-Level Time/Event Schedule

2019

Selected single cannabinoid for INM-755Contracted additional preclinical safety studiesAnalyzed potential EU clinical sites for Phase 1 healthy volunteer studies

Completed requisite tasks for clinical trial initiation:

- CTA-enabling toxicology program

- Product manufacturing for Ph 1

- Investigator’s Brochure and CMC summary for CTA

- Filed CTA in the Netherlands; CTA approved

Initiated Phase 1 Trial 755-101-HV

1H 2020 2H 2020

Exhibited key preclinical data at EB World Congress

Completed enrollment in 755-101-HV

Filed CTA in the Netherlands for 755-102-HV

Completed patient treatment in755-101-HV

Initiation of Phase 1 Trial 755-102-HV

Report results from 755-101-HV

Compete enrollment in755-102-HV

Complete patient treatment in 755-102-HV

Report results from 755-102-HV

Prepare and file global regulatory submissions for 755-201-EB trial (4Q20 – 1Q21)Completed Pending


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Glaucoma Epidemiology & Market Opportunity

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● In 2010, 44.7 million people worldwide were affected by OAGo Open Angle Glaucoma (OAG), the most common form

o More than 2.8 million Americans are living with glaucoma; projected to surpass3.4 million in 2020

o Second leading cause of blindness worldwide as well as in the USA

● There is no current cure for glaucomao Early diagnosis and treatment can control the disease before vision loss or blindness

o High intraocular pressure does not cause glaucoma; it is only a risk factor

● Global glaucoma market anticipated to be US$10 billion by 2026o Valued at US$6 billion in 2018

o CAGR of 6.1%


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Potential Roles for CBN in Glaucoma

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• Direct neuroprotection for the retina and optical nerve.

• Reduce the intraocular pressure (IOP) in the affected eyes via increased fluid drainage

Target Effects of CBN

Build Up of Aqueous

Humor Fluid

Optic Nerve

Pressure

Retina


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INM-088: CBN Ocular Preclinical Studies

CBN Preclinical Study Neuroprotection IOP Reduction

RGC Survival under pressure (in vitro)

Effect on RGC apoptosis (in vitro)

Impact on IOP associated biomarkers under pressure conditions (in vitro)

Neuronal function after CBN Exposure in Glaucoma model (measured by pERG, in vivo)

IOP reduction after CBN Exposure in Glaucoma model (in vivo)


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INM-088: High-Level Time/Event Schedule

2019 2020 2021

Complete selection of API

Initiate / complete preliminary preclinical neuroprotection studies

Filed PCT patent for neuroprotection

Complete formulation data analysis & select preferred delivery technology

Conduct additional PoCpreclinical studies (if needed)

Initiate IND/CTA enabling toxicology studies

Complete IND/CTA enabling toxicology studies

File IND/CTA

Initiate Clinical Trial Program

Completed Pending


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Intellectual Property Portfolio and Commercial Exclusivity

INM-755(EB)

INM-088(Glaucoma)

Biosynthesis / IntegraSynTM

• 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 2020)• Hydrogel formulation

(PCT 2018)

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


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Key Upcoming Milestones*

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IntegraSynTM 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

• Prepare and file global regulatorysubmissions for 755-201-EB trial (4Q20 – 1Q21)

• Initiate Phase I/II EB trial (2021)

• 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 and select preferred delivery technology

• Conduct additional preclinical studies (if needed)

• Initiate and complete IND/CTA enabling toxicology studies

• Prepare and file IND/CTA (2021)

• Initiate first clinical trial (2021)

* Latest best estimates. InMed is in frequent communication with our vendors and collaborators to monitor the COVID-19 situation and ‘return-to-work’ guidelines.


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Board of Directors

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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.


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Scientific Advisory Board

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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 applications, 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 fromMIT


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Financial Snapshot

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:IMLFF :IN

Previous Close (2020-07-03) US$6.75 C$9.1952-week High US$11.08 C$14.8552-week Low US$3.63 C$5.61Avg. Volume (Daily; Trailing 3 Month) 8,611 5,249Market Cap, I/O (2020-07-03) US$35.2M C$47.8M

Shares I/O 5.22 M

Options 0.59 M

Fully Diluted Shares (2020-07-03) 5.81 M

Cash Equivalents and Short-term Investments US$7.0 million at March 31, 2020

Note: All share numbers, price and trading data above give effect to a share consolidation (33:1) effective July 3, 2020 (US$1 = C$1.36).


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InMed at a Glance

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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…


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]

http://www.inmedpharma.com/

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