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FarmtoPharm™ 1 Corporate Presentation TSXv: GSD August 2020

Transcript of Corporate Presentationgroupedevonian.com/wp-content/uploads/2020/08/devonian...Corporate...

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FarmtoPharm™ 1

Corporate Presentation

TSXv: GSD

August 2020

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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

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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

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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)

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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

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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

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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

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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™

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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

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Sourcing Prescription Plant-Based Drugs

Pharmaceutical Drug

Company

Sources

Organic Plants

ThykamineTMC R-Spinasome®

Inflammation Cosmeceuticals

Cannabis

Cannabinoids :

CBDs and Terpenes

Anti Infective Dermatology

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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

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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

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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

*

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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

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• 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

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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)

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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)

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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

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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.

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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

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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.

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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

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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

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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

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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

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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

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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.

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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

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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