tetra bio-pharma · tetra bio-pharma global leaders in cannabinoid-based drug discovery and...

TETRA BIO-PHARMAGlobal Leaders in Cannabinoid-Based Drug Discovery and Development

DECEMBER 2019

Corporate Presentation I 2

Forward Looking StatementsSome statements in this presentation may contain forward-looking information. All statements, other than of historical fact, that address activities,

events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements

regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the

words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or

other variations on these words or comparable terminology.

Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict,

that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could

cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the

Company, to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and

delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and

uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and

other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities.

Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in

forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should

not place undue reliance on forward-looking statements. The forward-looking statements included in this presentation are made as of the date of this

presentation and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information,

subsequent events or otherwise unless required by applicable securities legislation.

Corporate Presentation I

Leader in cannabinoid-derived drug discovery

and development

Second asset entering Phase 2 in 2020 for painful dry

eye and uveitis pain

Pursuing large addressable markets in

Chronic Pain and Ophthalmology

Broad global intellectual property portfolio with patents

extending out to 2034

Lead asset CAUMZTM entering pivotal trials for

advanced cancer pain; anticipated approval in

U.S. and Canada by late 2020

Experienced leadership with expertise in running

clinical trials that meet both Health Canada and FDA

requirements

Investment Highlights

3


Guy Chamberland

CEO & CRO

Holds M.Sc. and Ph.D.

degrees

Victhom Laboratory

Angiogene Inc.

CATO Research Ltd

MDS Pharma Services

Sabino Di Paola

CFO

Holds CPA, CA designation

Pricewaterhouse Coopers

BDO Canada

Previous CFO at several

publicly traded companies on

the CSE and TSX Venture

Exchange

Aurélia De Pauw

VP Clinical Operations

Holds M.Sc. and Ph.D.

degrees

Over 10 years of scientific

research in academia and

research institutes

Previous Director of

Clinical Programs at Tetra

Bio-Pharma

Steeve Néron

Chief Operating Officer

Over 30 years of sales and

marketing experience in the

pharmaceutical industry

Pfizer

Schering

Sanofi Aventis

Bausch Health Canada

Melanie Kelly

Chief Scientific Officer

Holds Ph.D. degree

CSO Panag Pharma Inc.

Dalhousie University

Executive Director

International Cannabinoid

Research Society

4

Experienced Management Team


DRUG DEVELOPMENT PROGRAM PRE-CLINICAL PHASE 1 PHASE 2 PIVOTAL

Chronic Pain

Ophthalmology (PPP003)

Oncology

Drug Development Pipeline

Advanced Cancer Pain (CAUMZTM)

Breakthrough Pain (CAUMZTM)

5

Painful Dry Eye

Uveitis Pain

SERENITY ©

PLENITUDE © Advanced Cancer Pain (QIXLEEFTM)

Hepatocellular Carcinoma

REBORN ©


Target Markets

(1) Medtracks 2018; (2) Painful dry eye, uveitis;

(3) Advanced cancer pain, breakthrough pain, fibromyalgia

Worldwide Addressable Market in Billions ($CA)(1)

Ophthalmology (2) Chronic pain (3)

11.1

9.5

Chronic Pain:

• Approximately one in five, or ~1.5B people, are affected by chronic pain

worldwide, with another one in ten adults diagnosed each year

• Current treatment options such as opioids are associated with a

significant number of side effects, complications and addiction

• Lack of scientific evidence for long-term effectiveness and serious

safety concerns of opioids demonstrate the need for alternative options

when physicians prescribe medicine to treat symptoms of chronic pain


CAUMZTM

a cannabinoid-derived therapeutic composed of pure synthetic THC

and CBD for use in treatment of chronic pain

CAUMZ7

01 A non-opioid alternative to treat pain

02Entering pivotal trials for advanced cancer pain; in Phase 2 for

breakthrough pain in cancer patients; plans to pursue fibromyalgia

03Aimed at improving patient quality of life while reducing malignant cancer

pain and other uncontrolled pain as an adjacent to standard palliative care

04Speed of onset – Rapid absorption due to inhaled delivery providing pain

relief within minutes versus up to one hour with opioids

05 Pursuing partnerships / licensing deals prior to commercialization


QIXLEEFTM – CAUMZTM First Generation

• Rx Dry Pellet

• Blend of strains of cannabis to create a drug

substance with 9.5% THC/ 2.5% cannabidiol

• Ground and mixed to obtain uniform blend

• Pharmaceutical cGMP production BLEND OF 3

STRAINS

Blend processing

to make pellet

aims to maximize

dose uniformity

Active

Pharmaceutical

Ingredients

DRUG PRODUCT

Fixed Dose

Cannabis dry pellet


QIXLEEFTM Safety Data

STUDY DRUG• Dry pellet of 9.5 % THC; 2.5% CBD

• Administered by SMOKING or VAPING

DOSAGE• SAD: 1 to 3 doses, 1 day

• MAD: 1 to 3 dose per day, up to 7-day treatment

AE

• All subjects experienced at least 1 drug-related TEAE (euphoria); A dose-related trend was observed in the number of TEAEs reported

with increasing doses

• The majority of AE were of mild intensity; Severity level was reduced to moderate to mild intensity with safety titration strategy

• The majority of AE were resolved at the end of the studies

• 0% SAE

SAFETY

BIOMARKERS

• Biochemistry, hematology and urinalysis values generally within reference range

• Mean VS values within normal range

• No clinically significant abnormalities in ECG assessments; The study drug caused a shortening of the PR interval, consistent with an

increased heart rate in the first 60 minutes following inhalation and had no meaningful impact on the QRS interval

9


QIXLEEFTM Phase 1B data

• No AEs of fainting

• No moderate-severe AEs (severity reduced to minimal)

2 inhalations 3 inhalations 4 inhalations 5 inhalations Full dose inhalations

Day 1 Day 2 Day 3 Day 4 Day 5 and beyond

Adverse Event

Number of Symptoms in Phase 1ANumber of Symptoms in

Phase 1B (once a day)

Number of Symptoms in

Phase 1B (twice a day)Placebo PPP001

Dizziness 2/12 (~17%) 8/32 (25%) 2/24 (~8%) 0/24

Headache 2/12 (~17%) 7/32 (~22%) 2/24 (~8%) 1/24 (~4%)

Fainting 0/12 2/32 (~6%) 0/24 0/24

Pallor 2/12 (~17%) 7/32 (~22%) 0/24 0/24

15 min dosing period

Effectively used in 7-Day Repeat

Dose Safety Study (Phase 1B)

10


CAUMZTM : Bridging the First to the Second Generation

1. Analysis of vapor content in QIXLEEF™

2. Bridging vapor content between QIXLEEF™ and CAUMZ™

through analysis of absolute recovery in the vapor versus

loading doses in the capsules

+ =

Drip padDosing capsule

Drip dosing capsule

Current Investigational Drug (PPP011) Previous Investigational Drug (PPP001)

Topview

Sideview

A B

C D

E GF

QIXLEEF™ CAUMZ™


CAUMZTM: Controlling Quality – Release Testing

12

Patient loads “capsule + pad

combo” into vaporizer

Drug substance or API (Active Pharmaceutical Ingredient):

• Synthetic THC and CBD

• Stability program

• No impurities

Drug product• Combination of THC/CBD (9.5 %; 2.5%)

• Quantitative – validated assay

• Dose uniformity – less than 4% capsule-to-capsule variability


• Combination with Mighty Medic vaporizer, a Class 2 Health Canada approved device

Lyophilize

capsule + pad

Blister pack and vacuum seal

“dosing capsule + pad combo”


Per FDA Guidance for Industry - Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products; 1998. "The added rigor

and size of contemporary clinical trials have made it possible to rely, in certain circumstances, on a single adequate and well-controlled study,

without independent substantiation from another controlled trial, as a sufficient scientific and legal basis for approval."

PK/PD & Safety

Clinical studies in healthy volunteers

(botanical source of THC and CBD)

Validated surrogate endpoint

(PK/PD)

Phase 1

Substantiation

Phase IA and 1B

Substantiation

One single pivotal trialAdequate and well-controlled

CAUMZTM

NDA

13

Accelerated Development Path


Serenity Pivotal Trial

Trial Design

• Double-blind, placebo-controlled 4-Week Trial

• N = 334 adult patients (≥ 18 years of age) with advanced cancer

• Experiencing uncontrolled symptoms related to advanced cancer ( ≥ 2 symptoms on ESAS-R, including pain symptom)

• Multicentric study (25 sites Canada, US, Mexico)

• Followed by an open-label phase

Primary Endpoint

• To evaluate the efficacy of CAUMZTM to improve health related quality of life (HRQoL) of patients with uncontrolled symptoms related to

advanced cancer and incurable malignancy

Secondary Endpoints

• To assess the effect of CAUMZTM to improve on cancer pain and pain management; symptom burden; functional and nutritional status

• To evaluate the effect of CAUMZTM on: safety and tolerability; patient confusion and illness understanding; modification in amount and type of

concomitant medications; treatment satisfaction for caregivers; pharmacoeconomic impact

CAUMZ™ for pain management and health-related quality of life


SCREENING

ICF

Eligibility

Inhalation training

15

Serenity Pivotal Trial


EVERY 6 WKS LONG-

TERM FOLLOW-UP

Phone call

assessment

Until death, DO or

end of study

BASELINE VISIT

Personal

assessment by

research team

At the clinic

DAY 0 TO DAY 5

STS

Every day call

assessment by

research team

1-WK FOLLOW-UP

Personal assessment

by research team

At the clinic

4-WKS FOLLOW-UP

Personal assessment

by research team

At the clinic


Trial Design

• Pilot study to compare CAUMZ™ versus Immediate-Release Oral Opioids (Morphine Sulfate Immediate Release (MSIR))

- Sub-study 1: Proof of Concept: 5-week open label randomized crossover comparison study

- Sub-study 2: 4-week randomized double-blind, placebo-controlled

• N=60 adult patients (≥ 18 years of age) with breakthrough cancer pain and a stable opioid treatment for background pain

• 1 trial site in the U.S.

Primary Endpoint

• To compare CAUMZ™ to MSIR or placebo on onset of pain relief in breakthrough cancer pain (BTcP) patients

Secondary Endpoints

• To compare CAUMZ™ versus MSIR for their effects on patients’:

- Pain intensity, General impression of drug efficacy, Safety and tolerability, Cognition and mood, Health-related quality of life

• Amount and type of concurrent medications used for background cancer pain and breakthrough cancer pain


16

Reborn Phase 2 Trial


Trial Design

• Double-blind, placebo-controlled 4-Week Trial

• N = 78 adult patients (≥ 18 years of age) with advanced cancer and incurable malignancy

• Experiencing uncontrolled pain related to advanced cancer (pain ≥ 4 on ESAS-r-Cs)

• 1 to 2 trial sites in the US

• Followed by an open-label phase

Primary Endpoint

• To evaluate the effect of inhaled QIXLEEF™ on uncontrolled cancer pain in patients with advanced cancer and incurable malignancy

Secondary Endpoints

• To assess the effect of QIXLEEF™ on overall HRQoL; symptom burden; functional and nutritional status

• To evaluate the effect of QIXLEEF™ on: safety and tolerability; patient distress and illness understanding; treatment satisfaction for caregivers

and pharmacoeconomic impact

• To evaluate the effect of QIXLEEF™ on the modification in amount and type of concomitant medications, including opioids

QIXLEEF™ for pain management

17

Plenitude Phase 2 Trial


PPP003

a non-controlled cannabinoid-derived topical medicine for the treatment of

various ocular conditions

18

Entering phase 2 for uveitis and painful dry eye in 2020

Synthetic derivative of cannabidiol (HU308) that acts at CB2

receptors

Offers an alternative to steroids

Pursuing potential commercialization partners Ophthalmology

(PPP003)


PPP003: Controlling Quality – Release Testing

19

Drug substance or API (Active Pharmaceutical Ingredient;):

• PPP003. A1 – selective CB2 receptor agonist


• No impurities

Drug product

• Combination of PPP003.A1 in unique preservative-free nanoemulsion delivery vehicle

• Quantitative – validated assay

• Dose uniformity


• Individually dosed in blow sealed packaging/multidose container system


Intellectual Property Portfolio

PROPRIETARY

Compositions of matter and methods of use for treatment of ocular inflammation and/or pain

Ophthalmic formulation in dry eye and uveitis/corneal neuropathic pain

Composition of matter and method of delivery of cannabis derived drugs for inhalation

LICENSED THROUGH JOINT VENTURE WITH ALTUS FORMULATION

Routes of administration covering oral, topical (including eye), intranasal, intravenous, inhalation

Flexitab : breakable controlled release tablets

Smartcelle : insoluble drug delivery

Intellitab : abuse deterrent formulations

LICENSED THROUGH JOINT VENTURE WITH CRESCITA THERAPEUTICS

Topical formulation patents


Key Upcoming Milestones

Q4 2019 1H 2020 2H 2020

Regulatory Dec. 2019

FDA decision on proceeding with one pivotal

trial for CAUMZ™ and granting of

Accelerated/Fast Track approval

Clinical Q1 2020

Initiate treatment phase of Serenity pivotal

trial for CAUMZ™ in advanced cancer pain

Regulatory Late 2020

Anticipated approval in the U.S. and Canada

for CAUMZ™ in advanced cancer pain

Regulatory Dec. 2019

Initiate regulatory process for Conditional

Notice of Compliance from Health Canada

for CAUMZ™ in advanced cancer pain

Clinical Q1 2020

Resume Phase 2 Reborn trial for

CAUMZ™ in breakthrough pain

Clinical 2020

Initiate Phase 2 trials for painful dry eye and

uveitis

Clinical Q4 2019

Obtain scientific & ethics approval from 20

clinical sites Canada & USA for Serenity trial

(CAUMZ™) (including DEA for Schedule 1)

Clinical 1H 2020

Resume Phase 2 Plenitude trial for

QIXLEEF™ in advanced cancer pain

21

Corporate Presentation I 22(1) Aphria Inc. owns 26.9M shares (16.1% of shares outstanding)

TSX-V (TBP) CAD $0.51

OTCQB (TBPMF) USD $0.38

Market Capitalization CAD $123M

Shares Issued 212.8M

Shares Fully Diluted 270.6M

Insider Ownership 16%

Cash/Equivalent CAD $5.6M (a/o 8/31/19)

Financial

Highlights (as of 10/31/19)


Leader in cannabinoid-derived drug discovery

and development

Second asset entering Phase 2 in 2020 for painful dry

eye and uveitis pain

Pursuing large addressable markets in

Chronic Pain and Ophthalmology

Broad global intellectual property portfolio with patents

extending out to 2034.

Lead asset CAUMZTM entering pivotal trials for

advanced cancer pain; anticipated approval in

U.S. and Canada by late 2020

Experienced leadership with expertise in running

clinical trials that meet both Health Canada and FDA

requirements

Investment Highlights

23

TETRA BIO-PHARMAGlobal Leaders in Cannabinoid-Based Drug Discovery and Development

tetra bio-pharma · tetra bio-pharma global leaders in cannabinoid-based drug discovery and...

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