tetra bio-pharma · tetra bio-pharma global leaders in cannabinoid-based drug discovery and...
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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
Corporate Presentation I
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
Corporate Presentation I
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)
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Painful Dry Eye
Uveitis Pain
SERENITY ©
PLENITUDE © Advanced Cancer Pain (QIXLEEFTM)
Hepatocellular Carcinoma
REBORN ©
Corporate Presentation I 6
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
Corporate Presentation I
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
Corporate Presentation I 8
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
Corporate Presentation I
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
Corporate Presentation I
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
Corporate Presentation I 11
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™
Corporate Presentation I
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
• Stability program
• Combination with Mighty Medic vaporizer, a Class 2 Health Canada approved device
Lyophilize
capsule + pad
Blister pack and vacuum seal
“dosing capsule + pad combo”
Corporate Presentation I
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
Corporate Presentation I 14
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
Corporate Presentation I
SCREENING
ICF
Eligibility
Inhalation training
15
Serenity Pivotal Trial
CAUMZ™ for pain management and health-related quality of life
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
Corporate Presentation I
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
CAUMZ™ for pain management and health-related quality of life
16
Reborn Phase 2 Trial
Corporate Presentation I
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
Corporate Presentation I
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)
Corporate Presentation I
PPP003: Controlling Quality – Release Testing
19
Drug substance or API (Active Pharmaceutical Ingredient;):
• PPP003. A1 – selective CB2 receptor agonist
• Stability program
• No impurities
Drug product
• Combination of PPP003.A1 in unique preservative-free nanoemulsion delivery vehicle
• Quantitative – validated assay
• Dose uniformity
• Stability program
• Individually dosed in blow sealed packaging/multidose container system
Corporate Presentation I 20
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
Corporate Presentation I
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)
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
23