Corporate Presentationgroupedevonian.com/wp-content/uploads/2020/08/devonian...Corporate...
Transcript of Corporate Presentationgroupedevonian.com/wp-content/uploads/2020/08/devonian...Corporate...
FarmtoPharm™ 1
Corporate Presentation
TSXv: GSD
August 2020
FarmtoPharm™2
Certain statements contained in this document constitute forward-looking information and forward-looking statements (collectively, “forward-lookingstatements”) pursuant to the Applicable Securities Regulations. All statements, other than statements of historical fact, contained in this document are forward-looking statements, including, without limitation, statements regarding the future financial position, business strategy, budgets, projected costs and plans andobjectives of Devonian. The use of any of the words “anticipate”, “intend”, “continue”, “estimate”, “expect”, “may”, “will”, “plan”, “project”, “should”, “believe” andsimilar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties andother factors that may cause actual results or events to differ materially from those anticipated in such forward-looking statements. Devonian believes theexpectations reflected in those forward-looking statements are reasonable, but no assurance can be given that these expectations will prove to be correct and suchforwarding-looking statements speak only as of the date of this document and the Prospectus.
Some of the risks which could affect future results and could cause results to differ materially from those expected in the forward-looking statements containedherein include, but are not limited to: the development and the revenues generated, the regulatory approvals, the capacity for Devonian to develop alternativeproduct candidates, the commercialization process, the success of third-party strategic collaborators, the breakthrough designation by the FDA and marketapproval, the fast track designation by the FDA, the intense competition from other companies, the competition from product for which no prescription isrequired, the ongoing obligations and continued regulatory review, the compliance with recently enacted and future legislation, the third-party coverage andreimbursement and health care cost, the termination or suspension of, or delays in the commencement or completion of, any necessary future studies, thedevelopment process of clinical drug, the reliance on third parties to conduct its clinical trials, the availability and supply of raw material, the protection ofintellectual property right, the potential infringement on others’ intellectual property rights, the possibility to never become profitable, the need and ability toaccess sufficient capital, the management of growth, the ability to retain highly qualified personnel, the impact of a liability lawsuit brought, the potential futureacquisition, the achievement of publicly announced milestones, the price of the securities that may fluctuate, the intention not to pay any dividend, there can be noassurance that an active market for the Subordinate Voting Shares of Devonian and opportunities or transactions that may adversely affect its business andfinancial condition.
With respect to forward-looking statements contained in this document, Devonian has made assumptions regarding, among other things the ability to attract andretain qualified individuals and equipment in a timely manner, the level of future capital expenditure required to exploit and develop botanical pharmaceuticaland derma-cosmeceuticals products, the ability to obtain future financing on acceptable terms, and the state of the debt and equity markets in the currenteconomic environment.
Cautionary Statements
FarmtoPharm™3
▪ Incorporated in 2015 and is headquartered in Québec,
Canada.
▪ A late stage Plant-Based Pharmaceutical company.
▪ Core strategy is to develop prescription plant-based drugs
for the treatment of inflammatory-autoimmune diseases (e.g.
ulcerative colitis and atopic dermatitis).
▪ Pharmaceutical approach respecting all Health Canada and
FDA Regulations.
▪ A foundation of over 15 years of research.
▪ Management with solid track record of execution.
Overview Experienced Team
• Pharmaceutical-grade production facility
meeting Cleanroom Standards (ISO 14644-1).
• With full traceability ‘from the seed to the pill’.
LICENSED State-of-the-art extraction facility
• Over 44 patents issued and pending.
Solid Intellectual Property
Devonian Health Group (TSXv-GSD)Farm to PharmTM
FarmtoPharm™4
Prescription Plant-Based Drug Field and its Benefits
▪ Specific FDA regulations ; Botanical Drug Regulation
▪ The FDA has already approved a number of plant-based drugs;
▪ More than 800 New Drug Research (IND) and Pre-IND (PIND) meeting requests in the past year (1).
Benefits over Synthetic/Highly Purified Drug
▪ Faster preclinical development;
▪ Less costly;
▪ Up to 5 years market exclusivity (US) with or
without patent;
▪ Difficult to make a copy/generic
Next Wave in Pharmaceuticals
1) Investigational New Drug (IND)
FarmtoPharm™5
Botanical Drug Regulation : Approved Prescriptions
PRODUCT INDICATION OWNER OF MARKETING AUTHORIZATION
Veregen® 1 • Rx external genital and perianal warts Fougera Pharmaceuticals, a subsidiary of SANDOZ/NOVARTIS(US$200Bn market cap)
Curasite™ 2 • Rx of Diabetic Foot Ulcers, Leg Ulcers etc. IZUN PHARMACEUTICALS(5)
Privately-owned company
Fulyzaq® 3,4 • Symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
Salix Pharmaceuticals, a division of BAUSCH HEALTH(US$7Bn market cap)
1:Veregen® Product Monograph, Paladin Labs, March 22, 2016.
2: Izun Pharmaceuticals , Press release, March 06, 2017.
3. American Botanical Council, FDA Approves Crofelemer as First-Ever Oral Botanical Drug, January 2, 2013
4. Napo Pharmaceuticals, Mytesi Prescribing Information (www.mytesi.com), 2019
5. Izun Pharmaceuticals is a US based clinical stage pharmaceutical company with a wholly owned R&D center in Israel. Izun’s technology platform allows it to develop botanical drugs by optimizing and purifying the extracted
botanical compounds to yield polymolecular drug candidates
FarmtoPharm™6
Management Board of Directors
André P. Boulet, PhD
President & Chief Executive Officer
Nathalie Boucher, PhD
Director Research & Intellectual Property
Sybil Dahan
President of Altius Healthcare
Colette Laurin
Interim CFO
André P. Boulet, Ph.D.
Jacques Bernier, B.Pharm, MBA
Guy P. Dancosse, Q.C., Icd.D., Circ
Sybil Dahan
Louis Flamand, PhD, MBA
Terry L. Fretz
Tarique Saiyed
Advisory Boards
Pharmaceutical Cannabinoids R&D Program
• Dr Louis Flamand, PhD, MBA (Laval University)
• Dr Suha Jabaji, Ph.D (McGill University)
• Prof François Malouin, PhD (Sherbrooke University)
• Dr John Trant, PhD (Windsor University)
• Dr George Zhanel, PhD (University of Manitoba)
Development of Cannabinoids Pharmaceutical Products
• Dr Sam Hanna, MD, FAAD, DABD
• Dr Ian D.R. Landells, MD, FRCPC
• Dr Jaggi RAO, MD, FRCPC
• Dr Jerry Tan, MD, FRCPC Dermatology
Strong Leadership and Advisory Groups
FarmtoPharm™7
Devonian’s 4-Pillar Strategy
Proprietary
Technology and Licensed
Production Plant
Approach Respecting FDA
and Health Canada
Regulations
Focused Large
Commercial Unmet Medical Needs
Building Consortium of Experts
FarmtoPharm™8
SOURCING EXTRACTION DEVELOPMENT COMMERCIALIZATION
Botanical Drug Active Complexes(‘‘Entourage’’ effect of extracts)
Traditional Pharmaceutical Chemical Entities
Natural Health ProductsFunctional Foods, etc.
Non-synthesis
Chemical synthesis
This process ensure traceability: genuine pharmaceutical approach
TECHNOLOGY: Innovative and Patented Platform: SUPREX™
FarmtoPharm™9
Pharmaceutical Grade
• Full scale facility with custom designed equipment
• Pharmaceutical-grade production facility meeting
Cleanroom Standards (ISO 14644-1)
• Expect to seek good manufacturing practice (cGMP)
validation prior to Ph. III clinical trials
• Health Canada Research licence pursuant to the
Cannabis Act and Cannabis Regulations
Processing Facility• 1,625 square meters
• Located in Montmagny (Québec)
• Water system upgradable to produce injectables / sterile
eye solutions
• Cost $10 million
Intellectual Property
✓ Over 44 patents issued or pending
✓ 7 Trademarks
LICENSED Pharmaceutical-grade (cGMP) production facility
FarmtoPharm™10
Sourcing Prescription Plant-Based Drugs
Pharmaceutical Drug
Company
Sources
Organic Plants
ThykamineTMC R-Spinasome®
Inflammation Cosmeceuticals
Cannabis
Cannabinoids :
CBDs and Terpenes
Anti Infective Dermatology
FarmtoPharm™
Atopic Dermatitis (Eczema)
Dermatological botanical drug market
15-30% of children -
2-10% in adults
Ulcerative Colitis(Inflammatory Bowel Disease)
Gastrointestinal botanical drug market≲0.2% of population2
Choosing Lower Risk - Reward Initial Therapeutic Indications
Devonian’s Target Therapeutic Areas and Indications
1. Reports and Data, Feb 2020
2. Fact. MR, March 2020
3. The Insight Partners - 2019
Initial indications chosen for their favorable development and
commercial profile
• Medical need that is not currently being met.
• Studies can be carried out at low cost.
• Speed of execution of preclinical studies compared (central nervous system, psychiatric pathologies).
• Quick access to clinical staff and a large number of patients.
• Clinical trials with short timelines.
• Value markets.
Antibacterials / Antivirals(Human health and veterinary)
World Market
Forecasted by 2027
US$10Bn
US$19Bn
US$139Bn
11
FarmtoPharm™12
12
Strong drug candidate profile with potential to be “Best-In-Class”
Non-chemical therapy
Lower costs
(Mabs, Antisense, etc.)
Acceptance in
pediatric population
Fewer adverse effects
As a Botanical Drug, difficult
to copy (“Copycat-proof”1)
Potential 1st line therapy
in Ulcerative Colitis
(1) Dr Ray Jupp, VP Fibrosis and wound repair therapeutic strategic unit; Sanofi.
Primary Focus: Thykamine™ : Potential First Line Therapy
FarmtoPharm™13
Focus #1: Thykamine™: a Novel Anti-Inflammatory Drug
(1) A 2-Week Exploratory Randomized, Double-Blind, Parallel- Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of Pur 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis, Integrated Report prepared
by Focus Clinical Drug development GMBH for PurGenesis Technologies Inc. dated July 17, 2013; Supplementary Clinical Study Report for Additional Statistical Analysis Plan Pre-specified and Post Hoc Analyses – Supplement to the 2-Week Integrated Clinical
Study Report – Prepared by Biopharmatech Consulting, Inc. for Devonian Health Group, Inc., dated December 9, 2015.
Clinical Results (1) Clinical Symptoms (1)
Rectal Bleeding – Modified Mayo Sub-Score
13
Randomization
Placebo
1000 mg
250 mg
500 mg
Day 7
Day 7
Day 7
Day 7
Day 14
Day 14
Day 14
Day 14
Day 21
Day 21
Day 21
Day 21
Patients with left-
sided Mid-to-
Moderate
Ulcerative Colitis
(Flare)
-1.6
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
Placebo 250 mg 500 mg 1000 mg
Me
an
Ch
an
ge
fr
om
Ba
se
lin
e
in R
ec
tal
Ble
ed
ing
Su
b-S
co
re
* p,0.05 compared to corresponding placebo
Day 7 Day 14 Day 21
*
FarmtoPharm™14
Focus #1: Thykamine™, Day 21 - Outstanding Anti-Inflammatory effect
(1) A 2-Week Exploratory Randomized, Double-Blind, Parallel- Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of Pur 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis,
Integrated Report prepared by Focus Clinical Drug development GMBH for PurGenesis Technologies Inc. dated July 17, 2013; Supplementary Clinical Study Report for Additional Statistical Analysis Plan Pre-specified and Post Hoc Analyses –
Supplement to the 2-Week Integrated Clinical Study Report – Prepared by Biopharmatech Consulting, Inc. for Devonian Health Group, Inc., dated December 9, 2015.
14
-100
-80
-60
-40
-20
0
20
40
60
Placebo
Thykamine™ 250 mg/day
%
Biomarkers
FarmtoPharm™15
• Fast onset of action
• Impact on symptoms
• Decreased inflammatory and disease’s
biomarkers
• Feasibility of conducting a larger sample-
sized Phase 2b study
Focus #1: Thykamine™, a Novel Anti-Inflammatory Drug
• Phase 2 clinical trial completed (June 2020)
• Top-line results to be reported in November 2020
Demonstrated Benefits
after 14 days of therapy in UC
Benefits in Atopic Dermatitis (Eczema)
• Non-chemical therapy
• Rx : expected 4 weeks / Once-a-day
• Fast onset of action
• Potential 1st
line therapy in Ulcerative Colitis
• Therapeutic agent for Atopic Dermatitis (Eczema)
• Fewer Adverse Effects
• Botanical drugs are difficult to copy “Copycat”
• Other potential targets:
• Asthma• Cardiovascular Diseases• Diabetes
A Novel approach
FarmtoPharm™16
Focus #1: Thykamine™ - Atopic Dermatitis - Timeline
September 2021November 2020
Atopic Dermatitis
(Eczema)
• Adult – Phase 2
topline results to be
reported
Atopic Dermatitis
(Eczema)
• Pediatric – Phase 2
to be completed
June 2022
Agreement with large pharmaceutical
• Fall 2020; initiate the search for a pharmaceutical
partner
• Target reaching agreement: first half of 2022
• Value creation:
• Last 3 yrs >500 strategic alliances with
biotechnology companies for >US$34Bn(1)
• Phase 2 products average:
• upfront payments of US$125m
• agreement potential value of US$600m(1)
FarmtoPharm™17
Focus #1: Thykamine™ - Ulcerative Colitis - Timeline
June 2022March 2021
Ulcerative Colitis
• Phase 2b to be
initiated
Ulcerative Colitis
• Phase 2b clinical
trial
June 2022
Agreement with large pharmaceutical
• Fall 2020; initiate the search for a pharmaceutical
partner
• Target reaching agreement: first half of 2022
• Value creation:
• Last 3 yrs >500 strategic alliances with
biotechnology companies for >US$34Bn(1)
• Phase 2 products average:
• upfront payments of US$125m
• agreement potential value of US$600m(1)
FarmtoPharm™18
Recreational Medical Pharmaceutical
Gross Margins Low Low Hight >70%
CommercializationLimited by countries and regulated by
government
Limited by countries and regulated by
governmentGlobal
Target Market Consumer Consumer Physicians
Reimbursement None Some
Reimbursement (provincial
formularies, private payers,
HMOs, etc.)
Number of companies >100 >100 >10
Market potential US$47Bn1 US$21,5Bn1,2 US$220Bn1,3
Barriers to entry None Possible??? Manufacturing and patents
1) By 2027
2) Based on therapeutic targets : Cancer, arthritis and neurological disorders 3) Based on Devonian Targeted Therapeutics : anti-infectives, Dermatological and Ocular Disorders
Focus #2: Pharmaceutical Cannabinoids Program
FarmtoPharm™19
Renewed Interest for Cannabinoids from Large Pharmaceuticals is Emerging
Large Pharmaceutical companies
involved in clinical development Large Pharmaceutical Companies
Patents Ownership
59
3935 34
2825
17
40
38
8
7
5
4
2
1
1
GW Pharmaceuticals
Sanofi
GW Research Ltd
Solvay Pharmaceuticals
INSYS Therapeutics
Pfizer
Astra Zeneca
Par Pharmaceuticals
GlaxoSmithKline
The pharmaceutical industry is under intense pressure to become more efficient and develop better, faster and cheaper drugs.
FarmtoPharm™20
US FDA’s Approaches to Ensure the Therapeutic
Consistency of Botanical Drug Products 1
1. Adapted from : Scientific and Regulatory Approach to Botanical Drug Development : A U.S. FDA Perspective,. Wu C. et al., J. Nat. Prod. 38, 952-962, 2020
Cannabinoids: Perfecting the Manufacturing Like no other
Devonian’s Approaches to Cannabinoids-Based
Botanical Drugs
Totality of
the
Evidence
Multiple Dose and
Batches
Clinical Data
Well Controlled
Botanical Raw
Materials
Clinically-Relevant
Bioassay
Robust Chemistry,
Manufacturing and
Controls
Well Controlled Botanical Raw Materials
➢ cGMP Cultivation Systems: Strategic alliance with CannTx Life
Sciences Inc.
Robust Chemistry Manufacturing and Controls
➢ cGMP CO2 Extraction: MediPharm Inc./Gayonica/Other
Clinically-Relevant Bioassay and Multidose and Batches Clinical
Data
➢ Devonian’s Pre-clinical and Clinical Network
FarmtoPharm™21
Devonian is building a Consortium of Experts in the Field of Cannabinoids-Based Pharmaceuticals
Cannabinoids-Based
Pharmaceutical
Program
CannTx(Cultivars)
Extraction
• Positioning Devonian as the Canadian
/ World leader in the cannabinoid-
based pharmaceutical drug
development.
• As per FDA’s Botanical Drug
Regulations.
• Initiatives targeting the development of
new antimicrobials.
FarmtoPharm™22
Cannabinoids have demonstrated beneficial effects across a number of indications, attracting interest in many diseases while leaving others underserved.
Emblem, Tilray, GW Pharma, etc.. are focused other areas driven in part
from the large body of evidence and historical
use of cannabis
Unmet medical needs
Strong scientific rationale
Attractive market size US$220 Bn by 2027
Pain
Neuro-logical
Sleep Disorders
Anti-microbials
Dermato-logical
Ocular Disorders
Gastro-intestinal /
Other
Validated Disease
Areas for Cannabis
Significant Competition
Underserved
Our Proposed Focus
Large Commercial OpportunityTherapeutic Potential of Cannabis-based RX
FarmtoPharm™23
Focus #2: Antimicrobial DrugsBased on Cannabinoids - Timeline
January 2022April 2021
Genetic Screening of
Cannabis Plants
• Genetic screening of plants
• Tissue culture and selection of
plants for culture
• Flower collection and
extraction/franctionation
Identification of flagship product(s) in the
Humans, Veterinary and Food Industry
• Human and Veterinary:
• Bacteria resistant to antibiotics
• Acne
• Certain viruses including Covid-19, Herpes etc
• Food Industry:
• Antimicrobial compound(s) against fungal diseases
and bacterial contaminants present in the production
chains of the agro-food sector.
• Symbiotic bacteria that can be used as a biological
control agent.
December 2022
Agreement with large
pharmaceutical
Agreement with upfront
payment, co-development
strategy, and high single
digit royalty revenues
FarmtoPharm™24
R-Spinasome®
• Active structure extracted from
organic green leaves.
• Unprecedented durable anti-
oxidant activity.
Rationale - Research targeting cosmeceuticals (cosmetics with pharma-like clinical data) is intended to
maximize the value of findings from its prescription drug research.
• Global market for these products
is expected to reach
US$183Bn by 2025
• Worldwide sales and
marketing agreement with
SkinSciPac, a US based
company, behind the science-
based skincare company and
brand, PRIORI.
• Revenue expected Q4-2020
Innovative Skin Care Backed
by ScienceMarket Opportunity Exclusive Strategic Alliance
Focus #3: Development of Active Ingredients - Cosmeceutical market
FarmtoPharm™25
Focus #3: Development of Active Ingredients - Cosmeceutical market
June 2021
Blue Light Protective Cream
• Clinical study results
Marketing by our American
Distributor
(SkinSciPac)
Total Photoprotection Cream
(SPF / Infra-red A / Blue Light)
• Clinical study results
FarmtoPharm™26
Altius Healthcare - An Enabler to Devonian Strategy
• In 2018, Devonian acquired Altius Healthcare Inc.
• Altius’s business model is based on the acquisition or licensing of traditional pharmaceutical
drugs developed by others.
• Revenues from distribution of two pharmaceutical products, Cléo-35 and Pantoprazole
Magnesium.
• Projected overall revenues in 2021 and EBITDA from these two products are ~ C$12M and
C$2.4M
FarmtoPharm™27
Stock and Financial Information1
27
1) As of August 1st , 2020
Capital Structure1
Shares Outstanding:
Subordinate voting shares 62,556,017
Multiple voting shares (confers the right to 6 votes per share) 19,966,523
Total outstanding shares 82,522,540
Warrants 12,689,699
Stock Options 6,228,355
Fully diluted share capital 101,440,594
Long Term Debt
Secured Loan - TD Bank’s variable rate plus 6% repayable at maturity
January 2024
3,500,000
Convertible Debentures - Convertible into units at a price of $0.75/unit
plus 1 subordinated voting warrant at price of $0.95 for a period of 48
months. Interest at a rate of 10% calculated semi-annually (Ends 2022)
1,481,788
Total Long-Term Debt 4,981,788
Held by insiders
36%
Over 90% of shares are held by
Management’s network
investors.
FarmtoPharm™28
Investment Highlights and Value Accretive Milestones
28
Pharmaceutical Cannabinoid Consortium Announcement
Adult Phase 2 Eczema topline results and patent submission
Thykamine™ - Atopic Dermatitis
Pediatric – Phase 2
Thykamine™ - Ulcerative Colitis
Phase2b clinical trial with 225 patients
Cannabinoids-Based Pharmaceutical Program
Identification of flagship product (s) targeting bacteria resistant to
antibiotics, certain viruses, antimicrobial compound (s), and
symbiotic bacteria that can be used as a biological control agent
June 2022
October 2022
• Under Cannabinoids-based pharmaceutical
Consortium:
• July 2020 - Strategic alliance with Gayonica
• July 2021 - Formalizing JV with CannTx
• Agreement for Thykamine™ with large
pharmaceutical company (discussions have
begun):
• June 2022
• Agreement for flagship product under
Cannabinoids-based pharmaceutical program
• December 2022
Research and Development Potential Commercial Agreements
July 2021
September 2020
November 2020
FarmtoPharm™2929
Pharmaceutical Cannabinoid Consortium Announcement
Adult Phase 2 Eczema topline results and patent submission
Thykamine™ - Atopic Dermatitis
Pediatric – Phase 2
Thykamine™ - Ulcerative Colitis
Phase2b clinical trial with 225 patients
Cannabinoids-Based Pharmaceutical Program
Identification of flagship product (s) targeting bacteria resistant to
antibiotics, certain viruses, antimicrobial compound (s), and
symbiotic bacteria that can be used as a biological control agent
June 2022
October 2022
• Under Cannabinoids-based pharmaceutical
Consortium:
• July 2020 - Strategic alliance with Gayonica
• July 2021 - Formalizing JV with CannTx
• Agreement for Thykamine™ with large
pharmaceutical company (discussions have
begun):
• June 2022
• Agreement for flagship product under
Cannabinoids-based pharmaceutical program
• December 2022
Research and Development Potential Commercial Agreements
July 2021
September 2020
November 2020
THANK YOU