TETRA BIO-PHARMAGlobal Leaders in Cannabinoid-Based Drug Discovery and Development
March 9-10, 2021
H.C. Wainwright Global Life Sciences Conference
Stock Exchange TSX OTCQB
Ticker Symbol TBP TBPMF
Corporate Presentation I
Forward Looking StatementsSome statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that theCompany 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 actualresults 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 fromcurrent 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 intellectualproperty 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-lookingstatements, 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-lookingstatements. 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 topublicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
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Corporate Presentation I
CORPORATE PROFILE
Clinical stage biopharmaceutical company
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• Biopharmaceutical company with a pipeline of cannabinoid derived
medicines.
• Partnership with a medicinal chemistry USA-based biotech to ensure
new proprietary molecules for long term success.
• Executive & operational teams experienced in drug development.
Focuses:
• Immunomodulation
• Dissociative (e.g., increased threshold to sensation of pain)
Target markets:
• Sepsis/ ARDS, cytokine release syndromes (ARDS003)
• Acute and chronic pain (QIXLEEF, CAUMZ),
• CINV (Dronabinol soft gel DIN, PPP002),
• Antiviral inflammation,
• Inflammation CNS,
• Uveitis, diabetic retinopathy & other inflammatory conditions of the eye (PPP003).
Discovery
Identify New Molecule Entities (NME), establish Proof of
Mechanism and Proof of Concept, develop IP
Toxicology and R&D
Safety testing and Formulation development and
refinement
Clinical
Clinical testing from FIH to Phase IV
Manufacturing Clinical Trial Material / sterile,
GMP, Drug Establishment License (DEL)
(pharmaceutical finished product GMP),
Cannabis Drug License (CDL)
Take R&D formulation and develop it until
commercialization
Compliance
GLP, GMP & GCP audits
Regulatory and Licensing
Submissions for regulatory and licenses
A biopharmaceutical pioneer in immunomodulator
drug discovery and development with a FDA and a
Health Canada authorized/cleared clinical programs
aimed at bringing novel prescription drugs and
treatments to patients and their healthcare providers.
Corporate Presentation I
Intellectual Property Portfolio
PROPRIETARY - INHALATION
• Compositions of matter and methods of use for treatment of cancer cachexia and pain relief.
• Composition of matter and method of delivery of cannabis derived drugs for inhalation.
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Cytokine Storms, COVID-19 & Sepsis
2 PCT patent applications filed 2020:
• Manufacturing and purification API
• Composition and use of nano-emulsion
PPP-003: Ocular formulations
• 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.
Corporate Presentation I
Intellectual Property Portfolio - Licensed
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LICENSED - Manufacturing
(High-capacity manufacturing of cannabinoid products for inhalation or oral use)
• 2-D Drug printing patents using VitiPrint proprietary printing technology.
• Commerical scale-up for global sales potential.
PPP002 : Sustained delivery through buccal mucose membrane
• Intellectual Property (Sublicensed patents):
• US 8,735,374
• US 7,592,328
• CA 2,476,834
LICENSED – Formulation
• Flexitab – breakable controlled release tablets (US8795723; US8414919).
• Smartcelle – insoluble drug delivery (US6338859; US6939564)
• Intellitab – abuse deterrent formulations (US8691270; US8920833; US8920834)
Corporate Presentation I
MARKET OPPORTUNITY
ARDS / sepsis / Cytokine
The global immunomodulators market accounted for USD 131.7 billion in 2015 and is expected to grow at a CAGR of over 5.8% during the forecast period.
Inflammatory conditions
CNS
The market was valued at US$ 25.3 billion
in 2018 and is projected to reach US$
40.7 billion by 2026 with a CAGR of 6.1%.
Ophthalmic conditions
The global ophthalmic drugs market size
was valued at USD 31.0 billion in 2019
and is expected to expand at a CAGR of
5.0% from 2019 to 2027.
The global CNS drugs market is expected to
grow from $123.4 billion in 2019 to $136.7
billion in 2020 at a CAGR of 10.8%.
Pain indications
The pain management
market accounted for $58.6 billion in
2016, and is estimated to reach $77.1
billion by 2023, registering a CAGR of 4%.
IMMUNOMODULATOR
HU-308
Active Pharmaceutical Ingredient
ARDS-003
Cytokine storm & ARDSProprietary drug for intravenous injection
Current Priority
PPP-003
Ophthalmic inflammatory
conditionsProprietary eye drops
No binding to CB1 and very selective CB2.
CB1 receptor binding (agonist) – 6.8%
CB2 receptor binding (agonist) – 98.3%
Expansion to other indications post PoC in humans:
- Cancer – cytokine storm & sepsis
- encephalitis
- Antiviral market
Expansion to other indications post PoC in Uveitis
or Diabetic retinopathy:
- PVR
- Dry eye disease
- Keratoconjunctivitis
- Corneal neuropathic pain
Research Collaboration with
George Mason University
National Center for Biodefense
and Infectious Diseases (NCBID).
R&D partnership with Targeted
Pharmaceutical (Tetra acquired
20% of shares).
ARDS-003 being evaluated in
Sars-CoV-2 infected animals at
NCBID & study antiviral
properties.
Corporate Presentation I
12 years of Preclinical Evidence Supporting Use in these UnMet Medical Needs
Sepsis & septic shock
Cytokine release syndrome (CRS) & cytokine storm syndrome (CSS)
Systemic inflammatory response syndrome (SIRS)
Multi-Organ Dysfunction Syndrome (MODS))
Acute Respiratory Distress Syndrome (ARDS)
Research in Sepsis & hyperinflammatory reactions
Lehmann C, Kianian M. et al., Crit. Care. 2012
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√
√
√
√ First indication
LPS + NME
LPS + NME
LPS + NME
ARDS-003 has added benefits:
Post-survival management of lung fibrosis.
Expands prescription to out of hospital use thereby increasing revenues.
Clinical Trials for Marketing Approval
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Phase 1 –healthy
volunteers – Q1 2021
Phase 1/2a –compassionate
trial – ARDS patients – Q1
2021
Phase 2/3 –ARDS pivotal trial H2 - 2021
FDA Regulations (Life-Threatening condition): Single Phase 2/3 trial required for marketing approval
OCULAR HEALTH
The Burden of Ocular Disease
VISION IS RESPONSIBLE
FOR APROXIMATELY 38%
OF NEURONAL INPUT TO
THE BRAIN
THE EYE IS CONSIDERED
THE “WINDOW TO THE
BRAIN” WITH OPTIC
NERVE AND RETINA
REPRESENTING AN
EXTENSION OF THE
CENTRAL NERVOUS
SYSTEM.
GLOBAL COSTS OF VISION
LOSS > 3 TRILLION WITH
MORE THAN 2.2. MILLION
PEOPLE LIVING WITH
VISION IMPAIRMENT OR
BLINDNESS
1.Access Economics, prepared for AMD Alliance International, The Global Economic Cost of Visual Impairment, March 2010. www.amdalliance.org/en/
2. https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment
LPS
LPS + 1.5% HU308
Preclinical Evidence: CB2 Receptor in Ocular Inflammation
Anti-inflammatory effects of cannabinoid CB2 receptor
activation in endotoxin-induced uveitis
J T Toguri1, C Lehmann1,2,3, R B Laprairie1, A M Szczesniak1, J Zhou2,3,
E M Denovan-Wright1 and M E M Kelly1,4
Preclinical Evidence: CB2 Receptor Activation Compared to the Clinical Standard of Care
Anti-inflammatory effects of cannabinoid CB2 receptor activation in endotoxin-induced uveitisJ T Toguri1, C Lehmann1,2,3, R B Laprairie1, A M Szczesniak1, J Zhou2,3, E M Denovan-Wright1 and M E M Kelly1,4
DISSOCIATIVE – OPIOID REDUCTION
Corporate Presentation I 19
Development of inhaled QIXLEEFTM & CAUMZTM
2016
• FDA issues binding jurisdiction allowing smokable botanical cannabis drug; includes drug-device combination.
• First Type B meeting granted by FDA.
• 3 strain concept as API for PPP001.
2017
• Jan 2017 1st PIND/Type B meeting with FDA.
• Conduct of 1st Phase 1a & 1b trial in healthy volunteers: single and multiple dose escalation. Safety, PK, PD, cardiac.
• Launched smoke composition R&D using artificial lung model.
• Conduct of Phase 1 trial with oral capsules – safety & PK.
• Conduct of Phase 2 trial with oral capsules – 3 THC-CBD potencies – cancer and noncancer pain.
• Conduct of Phase 2/3 trial with PPP001.
• Conduct of Phase 1 trial with vaporized PPP001; expanded composition program to include vaporization.
2019
• Mycotoxin incident – Nov 2019 FDA agrees to Tetra quality program & clears Plenitude trial.
• Bridge between PPP001 & CAUMZ – drug is inhaled blend.
• CAUMZ – Synthetic APIs.
• VOC/Impurity composition program advances.
• Developed non-strain API strategy for QIXLEEF.
• VOC/Impurity safety strategy.
• FDA recognizes VOC/Impurity strategy for both CAUMZ & QIXLEEF.
• 3 key regulatory filings to FDA – FDA clears Reborn trial for QIXLEEF Jan 2021.
2018
2020
Inhaled Cannabinoid-based Drug
1. Safer profile than oral administration - No expected liver-induced
toxicity
▪ Better relative BioAvailability and lower 7-COOH-CBD than oral
CBD
2. Significantly Higher systemic absorption
3. Rapid onset of action
4. Relative low impact on cognitive functions
5. Drug characteristics favorable for pain indication and HRQoL
6. FDA favorable for second- or third-line therapy for adult patients with
uncontrolled pain
REBORN© Trial -QIXLEEF™ for Breakthrough Cancer Pain
10-week open-label randomized study to evaluate the effect of inhaled QIXLEEFTM compared to morphine sulfate immediate release (MSIR) to improve fast onset of pain relief of breakthrough cancer pain (BTcP).
Primary endpoint: time weighted Sum of Pain Intensity Differences (SPID) from pre-dose to 30 minutes (SPID30) after the first inhalation or after taking MSIR.
Secondary endpoints: difference in pain intensity and onset of pain relief at 5, 10, 15, 30 and 60 minutes, which will give insight to the timing of the onset of symptom relief for both treatments.
Study design: a screening and titration period of up to 2 weeks followed by an open-label crossover comparison study where each patient will receive the investigational drug and active comparator for a 7-week treatment period, during which the groups will switch treatments at week 3.
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BTcP is a rapid onset, high intensity, and short duration pain episode, which takes place within stable background pain control. The time to peak intensity of an episode ranges from 3 to 15 minutes with a duration of 30 to 60 minutes. They occur with a frequency of 1.5 to 6 times per day and the majority are moderate to severe in intensity. It significantly affects the quality of life of patients with cancer and their ability to function normally.
PLENITUDE©, FDA-approved Phase 2 trialQIXLEEF™ for pain management and HRQoL
• Trial Design
• Double-blind, placebo-controlled 4-Week Trial
• N = 78 adult patients (≥ 18 years of age) with advanced cancer
• Experiencing uncontrolled pain related to advanced cancer
• Multicentric study (6 sites US)
• Followed by an open-label phase
• Primary Endpoint
• To evaluate the effect of inhaled QIXLEEFTM on uncontrolled cancer pain in patients with advanced cancer.
• Secondary Endpoints
• To assess the effect of QIXLEEFTM to improve overall HRQoL, symptom burden, functional and nutritional status
• To evaluate the effect of QIXLEEFTM on safety and tolerability; patient confusion and illness understanding; modification in amount and type of concomitant medications (opioids); treatment satisfaction for caregivers; pharmacoeconomic impact
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Capital Structure
Stock Exchange TSX / OTCQB
Ticker Symbol TBP / TBPMF
Market capitalization * $ 80 million
Debt $ 2 million
Stock Price $ 0.27
Common Shares Outstanding 295 million
Warrants Outstanding 137.4 million ($0.21 to $1.30)
Stock Options Outstanding 5.4 million ($0.20 to $0.71)
Insider ownership 12%
Cash position Nov 30, 2020 $2.5 million
* Based on TSX closing stock price on February 17th 2021
Corporate Presentation I
Contact Information
Dr. Guy Chamberland – Chief Executive OfficerPhone: +1 (438) 899-7575
Steve Néron – Chief Commercial Officer Phone: +1 (514) 232-2851
Pascal Nigen – Managing PartnerAlpha Bronze, LLC (Investor Relations)Phone: + 1 (646) 255-0433 [email protected]
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