Cautionary Note Regarding Forward-Looking Statements TO THE EXTENT - - PowerPoint PPT Presentation

Cautionary Note Regarding Forward-Looking Statements

TO THE EXTENT STATEMENTS CONTAINED IN THE FOLLOWING PRESENTATION ARE NOT DESCRIPTIONS OF HISTORICAL FACTS REGARDING THE COMPANY, THEY SHOULD BE CONSIDERED “FORWARD-LOOKING STATEMENTS,” AS DESCRIBED IN THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995, THAT REFLECT MANAGEMENT’S CURRENT BELIEFS AND EXPECTATIONS. YOU CAN IDENTIFY FORWARD-LOOKING STATEMENTS BY WORDS SUCH AS “ANTICIPATE,” “BELIEVE,” “COULD,” “ESTIMATE,” “EXPECT,” “FORECAST,” “GOAL,” “HOPE,” “HYPOTHESIS,” “INTEND,” “MAY,” “PLAN,” “POTENTIAL,” “PREDICT,” “PROJECT,” “SHOULD,” “STRATEGY,” “WILL,” “WOULD,” OR THE NEGATIVE OF THOSE TERMS, AND SIMILAR EXPRESSIONS THAT CONVEY UNCERTAINTY OF FUTURE EVENTS OR OUTCOMES. FORWARD-LOOKING STATEMENTS CONTAINED IN THESE PRESENTATIONS INCLUDE, BUT ARE NOT LIMITED TO, STATEMENTS REGARDING: (I) THE SUCCESS AND TIMING OF OUR PRODUCT DEVELOPMENT ACTIVITIES AND CLINICAL TRIALS; (II) OUR ABILITY TO DEVELOP OUR PRODUCT CANDIDATES; (III) OUR PLANS TO RESEARCH, DISCOVER, EVALUATE AND DEVELOP ADDITIONAL POTENTIAL PRODUCT, TECHNOLOGY AND BUSINESS CANDIDATES AND OPPORTUNITIES; (IV) OUR ABILITY TO DEVELOP AND MANUFACTURE OUR PRODUCT CANDIDATES AND TO IMPROVE THE MANUFACTURING PROCESS; (V) OUR ABILITY TO ATTRACT AND RETAIN KEY SCIENTIFIC OR MANAGEMENT PERSONNEL; (VI) THE ANTICIPATED TIMING OF CLINICAL DATA AVAILABILITY; (VII) OUR ABILITY TO MEET OUR MILESTONES; (VIII) OUR EXPECTATIONS REGARDING OUR ABILITY TO OBTAIN AND MAINTAIN INTELLECTUAL PROPERTY PROTECTION; AND (IX) THE IMPACT OF CAPITAL MARKET CONDITIONS ON US. FORWARD-LOOKING STATEMENTS ARE SUBJECT TO KNOWN AND UNKNOWN FACTORS, RISKS AND UNCERTAINTIES THAT MAY CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED BY SUCH FORWARD LOOKING STATEMENTS. UNDUE RELIANCE SHOULD NOT BE PLACED ON FORWARD-LOOKING

• STATEMENTS. WE UNDERTAKE NO OBLIGATION TO PUBLICLY UPDATE ANY FORWARD-LOOKING STATEMENTS.

THE COMPANY’S INVESTIGATIONAL DRUG PRODUCTS HAVE NOT BEEN APPROVED OR CLEARED BY THE FDA.

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Emerald Health Pharmaceuticals

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A clinical-stage clinical-stage pharmaceutical company developing first-in-class first-in-class drug candidates to treat critical diseases with unmet medical need unmet medical need Our technology has a unique multi-pronged mechanism of action unique multi-pronged mechanism of action not seen with other molecules, not seen with other molecules, addressing validated targets validated targets for neurodegenerative, autoimmune, fibrotic & inflammatory diseases Preclinical studies demonstrate disease modification disease modification with the potential to reverse the progression of diseases which currently have no cure and cause significant mortality

Emerald Health Pharmaceuticals: Key Highlights

Strong IP & Significant Market Unique 
 Mechanism of Action Strong Team Broad patent Broad patent protection with a protection with a US$39B market US$39B market

• pportunity in the
• pportunity in the

first 4 targeted first 4 targeted diseases diseases New Chemical New Chemical Entities (NCEs) Entities (NCEs) with the potential with the potential for disease for disease modification in modification in diseases with no diseases with no current cure current cure Experienced Experienced biotech/pharma biotech/pharma executives and executives and globally- globally- recognized clinical recognized clinical and scientific and scientific advisors advisors

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Clinical Stage Development Lead product Lead product candidate to enter candidate to enter Phase 2 human Phase 2 human trials in Q4 2019 trials in Q4 2019 for multiple for multiple sclerosis & sclerosis & scleroderma scleroderma

Development Roadmap

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NOTE: In the scientific literature: EHP-101 = VCE-004.8 EHP-102 = VCE-003.2

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Status: Private Headquarters: San Diego, CA, USA R&D: Córdoba, Spain & Collingwood, VIC Australia

Focus

• cused

ed on

• n dev

devel elopi

• ping

ng pat patent ented ed synt nthet hetic c cannabi cannabinoi noid-der derived ed dr drug ug candi candidat dates es to tre treat d t diseases w with th unm unmet et medi edical cal need need

E m e r a l d P h a r m a . L I F E

Emerald Health Pharmaceuticals Emerald Health Pharmaceuticals

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Status: Private Headquarters: San Diego, CA, USA R&D: Córdoba, Spain

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The Technology: Patented NCEs Derived from CBD & CBG

• CBD & CBG have multiple

positive physiologic effects through interaction with the

the endocannabinoid system (ECS) endocannabinoid system (ECS)

• Research indicates they are:
• Anti-inflammatory
• Antioxidative
• Neuroprotective
• Analgesic
• Anti-infective
• Non-psychoactive

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CB1

Psychotropic 
 Health benefits?

Receptors

CB2

TRPV1 GPR55 FAAH PPARs MALG TRPA1

Non-psychotropic Health benefits

Distribution of CB1 Receptors

The ECS Exists Throughout the Body

• AUGMENT CBD & CBG receptor targeting
• FOCUS on receptors that can treat diseases with

unmet medical need

• DEVELOP composition of matter patented cannabinoid

new chemical entities (NCEs)

• CREATE a strong IP portfolio

To Im To Improve on prove on the the positive positive health effects of CBD and CBG health effects of CBD and CBG by modifying them to create enhanced molecules by modifying them to create enhanced molecules

Our Scientific Approach

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14 patented CBD derivatives 11 patented CBG derivatives

Molecules in our NCE Library

• Composition of matter patents
• Protection to 2037
• Potential for multiple

products and indications

• 14 granted, 18 pending, covering 25 molecules

Patents

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VCE-004.8

CB2 PPARγ

VCE-004.8 a CBD derivative

CB2 TRPV1 GPR55 FAAH PPARs MALG TRPA1

DRUG DISCOVERY SCREENING PLATFORM FOR ECS TARGETS

EHP’s 
 Cannnabinoid Library

PPARγ

VCE-003.2 A CBG derivative

Rational Drug Design: New Chemical Entity (NCE)

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NCE: A Non-Controlled Substance Cannabinoid

The U.S. Drug Enforcement The U.S. Drug Enforcement Administration (DEA) Administration (DEA)

• Unlike CBD

Unlike CBD (a controlled substance): (a controlled substance):

• VCE-004.8 (the active

ingredient in EHP-101) is not a controlled substance

• Indicative of complete

difference between our molecule and CBD

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Provides Many Therapeutic Opportunities

Parkinson’s disease Huntington’s disease

Neurodegenerative Fibrotic

Ulcerative Colitis / Crohn’s

Inflammatory Metabolic Auto-Immune Cancer

Diabetes

Development Roadmap

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NOTE: In the scientific literature: EHP-101 = VCE-004.8 EHP-102 = VCE-003.2

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Cannabidiol Cannabidiol (CBD) (CBD) derivative derivative

• CBD

BD: :

• Does not bind to CB1 (non-psychotropic)
• Safe, anti-inflammatory, neuroprotective,

analgesic, anti-proliferative

• Helps improve MS symptoms
• CBD

EHP-101

Lead Product Candidate: EHP-101

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GOAL: maintain these attributes and improve

• n the ability to treat diseases instead of just

address symptoms

Chronic inflammatory, degenerative, demyelinating CNS disorder


• Our molecule targets receptors associated with MS
• Current medications are most effective only during the

inflammatory phase; less potent as the disease transitions to a neurodegenerative process

• No effective disease-modifying drugs for progressive forms
• No therapies appear to re-myelinate damaged neurons

Main symptoms of

Multiple Sclerosis

EHP-101: Why Multiple Sclerosis?

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Multiple Sclerosis Normal

EHP-101 Can Potentially Re-Myelinate Nerves Damaged by MS

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Our strategy:

• To improve on CBD’s known

positive effects by affecting validated targets in MS:

• PPARγ
• CB2
• HIF

HIF 1 HIF 2

EHP 101

PPARγ CB2 PPARγ: Peroxisome proliferator-activated receptor gamma CB2: Cannabinoid receptor Type 2 HIF: Hypoxia inducible factor

CBD

EHP-101: Designed for Mechanism of Action

• validated targets in MS:

Reduces
 




 neuroinflammation Increases Neuroprotection Improves neuron survival 
 and repair Potential for Remyelination

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Dose response with efficacy at 5 mg/kg

Control (untreated): Treated:

Demonstrated efficacy in Demonstrated efficacy in MS MS models models

• Significant improvement in

clinical signs

• Stops neuroinflammation and

demyelination

• Remyelinates neurons

EHP-101: Efficacy Demonstrated in Multiple Sclerosis

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Untreated Control EHP-101: Efficacy Demonstrated in MS

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Video 1

Treated (20mg/kg) EHP-101: Efficacy Demonstrated in MS

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Video 2

EHP-101: Efficacy Demonstrated in MS - REMYELINATION

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EHP-101: Other Demyelinating Diseases

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Chronic, systemic autoimmune disease causing fibrosis of skin and internal organs Chronic, systemic autoimmune disease causing fibrosis of skin and internal organs

• Rare, life-threatening disease
• No SSc-specific approved drugs
• Current therapies not effective and

have significant toxicities

• Lung fibrosis is a common cause
• f death (~60% mortality in 10 years)
• EHP-101: Second Indication - Scleroderma

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• Scleroderma is a deadly disease with no

current treatment

• PPARγ and CB2: extensively studied

molecular targets for the treatment of scleroderma*

• Combined effect on PPARγ, CB2

and HIF not described for other types

• f marketed drugs
• Pre-clinical proof-of-concept established

in relevant animal models

*Minghua et al, Tavarares et al, Akhmetshina et al, Del Rio et al

EHP 101

PPARγ agonist CB2 agonist

Inhibition of collagen synthesis Inhibition of ERK activation Fibroblast migration decrease myofibroblast differentiation Anti-inflammatory activity in vivo Antifibrotic activity in vivo Vascular protection

HIF

EHP-101 targets MoA in scleroderma EHP-101: Why Scleroderma?

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Demonstrated efficacy in Demonstrated efficacy in SSc SSc models models

• Exerts potent antifibrotic effects

and prevents dermal thickening in the scleroderma BLM model

• Prevents collagen accumulation

around blood vessels

• Reduces macrophage infiltration

into the skin

EHP-101: Efficacy Demonstrated in Scleroderma

NATURE

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2017

H1 Formulation (oral), i Formulation (oral), initiated GLP tox studies and manufacturing for Phase nitiated GLP tox studies and manufacturing for Phase I I ✔ H2 US FDA grant of Orphan Drug Designation (ODD) for systemic scleroderma (SSc) US FDA grant of Orphan Drug Designation (ODD) for systemic scleroderma (SSc) and Huntington’s disease and Huntington’s disease ✔ EU EMA grant of ODD for SSc EU EMA grant of ODD for SSc ✔

2018

H1 Final clinical-enabling studies completed Final clinical-enabling studies completed ✔ Pre-IND meeting with US FDA (for Pre-IND meeting with US FDA (for MS MS Phase Phase II II preparation) preparation) ✔ H2 Phase Phase I human study human study initiated initiated ✔ (single Phase (single Phase I study expected to study expected to support Phase support Phase II II in both MS & scleroderma) in both MS & scleroderma)

• 2019

H1 Pre-IND meeting with US FDA (for Pre-IND meeting with US FDA (for SSc SSc Phase Phase II II preparation) preparation) ✔ H2 Complete Phase I study in Q3 Complete Phase I study in Q3 ✔ Phase Phase II II to start in Q4 to start in Q4

• EHP-101: Path to the Clinic

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Development Roadmap

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NOTE: In the scientific literature: EHP-101 = VCE-004.8 EHP-102 = VCE-003.2

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Cannabigerol Cannabigerol (CBG) (CBG) derivative derivative CBG: CBG:

• Does not bind to CB1 (non-psychotropic)
• Provides neuroprotection in models of Huntington’s

disease, partially through antioxidant and anti-inflammatory activity, and PPARγ modulation

• Suppresses norepinephrine, providing muscle

relaxation and analgesic properties through effects on the CNS

CBG EHP-102

EHP-102: Second Product Candidate

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Chronic, progressive neurodegenerative disorder with no current cure Chronic, progressive neurodegenerative disorder with no current cure

• More than 10 million people

worldwide have Parkinson's disease

• A disease where damaged neurons

do not produce sufficient dopamine (dopamine helps transmit impulses from the brain to the muscles)

• EHP-102 provides neuroprotection,

partially through PPARγ activity and reduction in proinflammatory mediators

• EHP-102: Why Parkinson’s Disease?

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Oral VCE-003.2 (20 mg/kg) in sesame oil

Pole test

10 20 30 40

SHAM 6-OHDA + vehicle 6-OHDA + VCE-003.2

*

##

Latency (s)

Cylinder rearing test

• 0.5

0.0 0.5 1.0

SHAM 6-OHDA + vehicle 6-OHDA + VCE-003.2

**

#

Score (preference for ipsilateral paw)

TH immunostaining

50 100 150

*** ***

##

SHAM 6-OHDA + vehicle 6-OHDA + VCE-003.2 Immunostaining density (%versus non lesioned side)

Lesioned side Non-lesioned side control + 6-OHDA + VCE-003.2

Demonstrated efficacy in Demonstrated efficacy in PD PD models models

• Improves clinical symptoms and

recovers movement parameters (motor coordination and activity) in the 6-OHDA model

• Reduces inflammatory marker

expression and prevents dopaminergic neuronal loss in the 6-OHDA model

• Efficacy also shown in the LPS model
• f Parkinson’s disease

EHP-102: Efficacy Demonstrated in PD

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Causes progressive breakdown of nerve cells Causes progressive breakdown of nerve cells

• An orphan disease
• EHP-102 targets PPARγ

with improved activity

• Also targets other pathways

involved in neuronal survival (ERK 1+2)

EHP-102: Why Huntington’s Disease?

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EHP-102: Efficacy Demonstrated in Huntington’s Disease

Clinical symptoms ameliorated Clinical symptoms ameliorated in models of HD: in models of HD:

• Improved motor function &

clinical scores with EHP-102

• EHP-102 positively affects

neuroprotection and neurogenesis

• EHP-102 also showed

efficacy in QA and 3NP models of HD

mtHtt

0.0 0.5 1.0 1.5 2.0

#

**

Latency Fold Increase VCE-003.2 Veh VCE-003.2 wtHtt mtHtt Veh

Figure 3 Click here to access/download;Figure;Figure 3.pptx

Clinical

NeuN+ cell/mm2

50 100 150 200

##

**

Veh VCE-003.2 Veh VCE-003.2 wtHtt mtHtt

Figure 4 Click here to access/download;Figure;Figure 4.pptx

DARRP32+ Cells/mm2

50 100 150 200 250

** **

##

Veh VCE-003.2 Veh VCE-003.2 wtHtt mtHtt

Figure 4 Click here to access/download;Figure;Figure 4.pptx

Neuroprotection

a b

mtHtt Veh VCE-003.2

5 10 15 20 25

** ###

Striatal DCX+ cells/mm2

**

##

Veh EHP-102 Veh EHP-102 wtHtt mtHtt NeuN+ BrdU+ /BrdU+ cells

20 40 60 80

***

###

**

##

Veh EHP-102 Veh EHP-102 wtHtt mtHtt

Neurogenesis

• ***
• γ
• γ

γ

• γ
• in vivo

+

• r

a

• OPEN

NATURE

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Jim DeMesa, MD, MBA MD, MBA

Chief Executive Officer 


30 years in pharma product development and management, including preclinical and clinical trial management, and partnering with pharma companies. 15 years as CEO of public biotech companies.

Nancy Coulson

SVP, Regulatory Affairs

30+ years in global pharma and biotech regulatory mgmt with J&J, BMS, and others.

Eduardo Muñoz, MD, PhD MD, PhD

Chief Scientific Officer, SAB Chairman

30+ years in biomedical research, Professor of Immunology, author 


• f 200 articles, patents and book chapters

with nearly 5,000 citations

Giovanni Appendino, PhD PhD

Scientific Advisor, SAB 


One of the worlds thought leaders in cannabinoid research; Professor of Pharmaceutical Chemistry at the University of Eastern Piedmont; Author 


• f 250 articles and 10 book chapters.

Alain Rolland, PharmD, PhD PharmD, PhD


Chief Chief Development Development Officer Officer

30+ years of leadership experience in R&D, strategic and business development

Avtar Dhillon, MD MD

Chairman 
 Chairman of 5 public life science companies, led turnaround of NASDAQ:INO from $10m to $550m Clinical Advisory Boards:

MS: Emmanuelle Waubant, MD, PhD 
 Juan Antonio Garcia-Merino, MD, PhD SSc: John Varga, MD
 Janet Pope, MD 
 Patricia Carreira, MD

Joachim Schupp, MD, Dr. med MD, Dr. med

Chief Medical Officer

30+ years in clinical drug development, medical monitoring and clinical trial mgmt with Ciba-Geigy, Novartis, & others

Lisa Sanford, CPA

CPA

Chief Financial Officer 


30+ years of diversified finance and accounting experience in life sciences, pharmaceuticals and biotechnology.

Rao Movva, PhD PhD

Scientific Advisor, SAB

30 years in drug discovery and development; Novartis Distinguished Scientist; pioneered chemical biology efforts that led to the discovery and the understanding of TOR pathways

Experienced Pharma & Biotech Management

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Foundation:
 Therapeutic effect 


• f CBD and CBG on

ECS Library of patented NCEs derived from 
 CBD and CBG with improved biologic activities targeting specific diseases 2 lead molecules, EHP-101 and 
 EHP-102, being developed for 
 4 initial indications Multiple additional molecules for new future indications

Emerald Health Pharmaceuticals Summary

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Combined MoA
 for EHP molecules 
 not described with 


• ther drugs

EHP-101 
 human clinical development advancing to 
 Phase II Orphan status granted for scleroderma and 
 Huntington’s disease Management team experienced in developing drugs and building companies

Emerald Health Pharmaceuticals Summary

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TO LEARN MORE PLEASE CONTACT :

Jim DeMesa, MD


CHIEF EXECUTIVE OFFICER
 EMERALD HEALTH PHARMACEUTICALS

• Bernie Hertel


VP FINANCE & COMMUNICATIONS EMERALD HEALTH SCIENCES

• T. 1 604 727 0106
• E. BH@EMERALD.LIFE
• T. 1 858 352 0622
• E. JIMDEMESA@EMERALDPHARMA.LIFE

Thank You

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Developing medicines based on cannabinoid science