biOasis Technologies, Inc., (BTI.TSXV & BIOAF.OTCQX) Presentation July 14
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Transcript of biOasis Technologies, Inc., (BTI.TSXV & BIOAF.OTCQX) Presentation July 14
OTCQX BIOAF !TSX.V BTI July 2014
OTCQX BIOAF TSX.V BTI
Forward Looking Statements Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments express or implied by such forward-looking statements or information.
Such factors include, among others, our stage of development, lack of any product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: products that we develop may not succeed in preclinical or clinical trials, or future products in our targeted corporate objectives; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and the costs of launching our products may be greater than anticipated; we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at www.sedar.com.
Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward- looking statements and information to reflect subsequent events or circumstances, except as required by law.
2"
OTCQX BIOAF TSX.V BTI
Market Profile OTCQX: BIOAF; TSX.V: BTI
3"
Data source: S&P Capital IQ Trailing twelve months as of Feb 28, 2014 Shares – June 23, 2014
52 Week Low-High ! $0.67 - $1.35 !(Jun. 23, 2014)
Shares Issued & Outstanding ! 41,963,130 "!Fully Diluted ! 48,485,405!Options !
"!6,272,275!($0.52 - $1.42) Directors, officers & employees
Warrants ! 250,000"!($0.575) Exp. 5/08/2016
Market Cap "! ~$52.9m !@ $1.26 Share Price (Jun. 23, 2014)
Cash Position $1,860,135 !(Feb. 28, 2014)
Ownership! Insiders & Affiliates ~35% !Institutional ~10%!
OTCQX BIOAF TSX.V BTI
Who we are… Board of Directors Rob Hutchison, Chair & CEO!Former: CEO & Chief Scientist at eCharge Corporation (World’s First Internet Payment System) Chris Fibiger, PhD !Former: Head of Neuroscience, Amgen; VP Neuroscience, Eli Lily & CSO, Biovail Laboratories !Greg Gubitz, LLB !Former: VP, Biovail Corporation (merged Valeant Pharmaceuticals) COO, MDS Capital (Life Science VC firm $1bn under management) Terry Pearson, PhD!Professor: Biochemistry & Microbiology, UVIC Bench-mates: Nobel Laureate, Dr. George Kohler (monoclonal antibody) Discovered & commercialized highly- successful SISCAPA Assay Technology !!Ron Erickson !Over 30 years experience: attorney & senior level executive Current: Chair & CEO, Visulant Technologies (nano-photonics company) Michael Hutchison, QC, LLB!Partner, Smith Hutchison Law Corporation
Team!
!Judi Dalling, LLB, CFO !Over 35 years accountancy experience Seasoned public company CFO and corporate lawyer !Wilfred Jefferies, PhD, Founding Scientist !Oxford University, Molecular Immunology Discovered p97’s ability to cross the BBB & Ox26 (foundational antibody for BBB research) Professor: Microbiology & Immunology, UBC !Reinhard Gabathuler, PhD, Chief Scientist !University of Lausanne, Switzerland, Plant Biochemistry Over 25 years experience, academic research & early-stage biotech companies Former: VP Brain Research, Biomarin & CSO, Angiochem Inc. !Mei Mei Tian, PhD, Scientist !UBC, Microbiology and Immunology Expertise in BBB transport, cell biology, molecular biology !Laura Ho, MSc, Scientist !UBC, Microbiology and Immunology !Tiffany Tolmie, Corporate Communications !Honours, Wilfrid Laurier University
OTCQX BIOAF TSX.V BTI
What we do… Brain Delivery Platform Patented “Transcend Family” of technologies allows drug therapies to penetrate the Blood-Brain Barrier (“BBB”) to treat diseases of the Central Nervous System (“CNS”) Potential treatments for:
Market Leading Technology
Transcend & Transcendpep ! 5"
Oncology Metabolic Diseases
Neurodegenerative Diseases
OTCQX BIOAF TSX.V BTI
The Blood-Brain Barrier Challenge
Blood Brain Barrier Protective barrier of the CNS preventing toxic compounds from entering the brain from the circulatory system
Problem BBB prevents therapeutics from entering the brain
• ~98% of small molecule drugs • ~100% of large molecule drugs1
Solution Discovering a ‘carrier’ to deliver therapeutic treatments across the BBB
i. Opportunity to extend patent life of existing drug therapies ii. Contribute to the growth in CNS drug market and revitalize
dormant candidates iii. Assist development of new therapies for currently untreatable
diseases
6"
1) Royal Society of Chemistry
Tightly"woven"capillary"network"of"endothelial"cells"lining"the"blood"vessels"in"the"brain,"which"is"responsible"for"maintaining"homeostasis"
OTCQX BIOAF TSX.V BTI
Breakthrough Solution
First Generation: Transcend • Known as Melanotransferrin (MTf or p97) • Native human protein found at low
concentrations in the blood • Technology patented at University of British
Columbia; later purchased by biOasis
7"
The Transcend Family …is a naturally occurring physiological transport mechanism … acts as a ‘Trojan-Horse’ to transport therapeutics across the BBB and into the brain tissue
Second Generation: Transcendpep
• A newly discovered peptide found within Transcend, which offers improved brain penetration over Transcend
OTCQX BIOAF TSX.V BTI
Advantage of Transcendpep
� Greater efficiency of BBB delivery � Lower cost of production � Improved quality control � Simpler to link to therapeutics � Transports a variety of compounds
with no apparent size limitation � Extends biOasis patent portfolio � Pharmaceutical collaborators
currently licensing Transcendpep
8"
BBB"
Transcendpep Therapeutic
Transcendpep in Action
OTCQX BIOAF TSX.V BTI
Market Opportunities Major Unmet Medical Needs Drug market limited by the BBB
9"
A carrier to cross the
BBB would establish a foothold
within these major
markets
Central Nervous System
~$81.2bn
Neuro-degenerative
Diseases
~$20bn
!
Stroke & Traumatic
Brain Injury
~$7.5bn
Pain & Migraine
~$33.7bn
2014 Estimates in $USD
Clinical need met but improved BBB penetration could increase efficacy
Psychiatry
~$32.3bn
Infection (Bacterial, Viral, Fungal)
~$138bn
Lysosomal Storage Disease !
>$1.9bn
OTCQX BIOAF TSX.V BTI
Brain Cancer Market Sales for Current Cancer Therapeutics Treatments for cancers, which frequently metastasize in the brain, Do Not cross the BBB in efficacious levels
10"
1) GlobalData “Brain Tumor – Pipeline Assessment and Market Forecasts to 2017” released Jan. 17, 2011. 2) Company Reported Data 3) BT2111 Program Results slides 19 & 20
$0.9B
$2.1B
2009 2010 2011 2012 2013F 2014F 2015F 2016F 2017F
($ Billions)
Global Brain Tumor Therapies Market1
Herceptin® (trastuzumab)
HER2+ Breast Cancer
Rituxan® (Rituximab) lymphomas, leukemias
Taxol® (Paclitaxel) lung, ovarian,
etc.
Erbitux® (Cetuximab)
Metastatic colon cancer,
etc.
$92 million in sales 20132
$7.5 billion in sales 20132
$1.9 billion in sales 20132
$6.6 billion in sales 20132
Results Trancend + Trastuzumab (Herceptin®) conjugate not only crossed the BBB but increased cancer killing activities throughout the body3
Opportunity Potential to increase effectiveness of cancer therapeutics and treat tumours that metastasize in the brain
$1.4 billion Market in 2013
OTCQX BIOAF TSX.V BTI
Multiple Development Opportunities Conjugated with Transcend: • Antibodies • Enzymes • Biologics agents • Small molecules drugs
Targeting:
11"
Patent Cliff Estimated ~$250 billion in lost revenue from patent expiration between 2012-20151
Transcend family linked with existing drugs offers the potential for patent term extensions through New Chemical Entity (“NCE”) "
Specific brain cells (e.g., neurons, astrocytes and glia)
Intracellular compartments (e.g., lysosomes, endosomes, mitochondria)
Delivery into the brain of existing therapeutic drugs currently not approved for CNS indications
Delivery into the brain of promising new agents in development
"""
1)"DeRuiter,"J.,"&"Holston,"P."L."(2012,"June"20)."Drug"Patent"ExpiraOons"and"the"“Patent"Cliff”."U.S."Pharm."2012;37(6)(Generic"suppl):12Y20.""
OTCQX BIOAF TSX.V BTI
Transcend: Rapid Uptake in Brain
12"
Compound Brain Kin (mL-1/s-1/g-1)
Reference
Glucose 9.5 x 10-3 Smith (2003)
Transcend 6.4 x 10-4 Demeule et al. (2002) Morphine 2.0 x 10-4 Cisternino et al. (2001) Aprotinin ! 1.6 x 10-4 Demeule et al. (2008)
Insulin Rec Antibody ! 1.0 x 10-4 Pardridge (1997) Leu-Enkephalin 6.0 x 10-5 Zlokovic (1987) Morphine-6-Glucuronide 2.4 x 10-5 Temsamani et al. (2005) RAP ! 1.0 x 10-5 Pan (2004) Beta Amyloid 6.5 x 10-6 Banks (1991) DADLE 6.5 x 10-6 Chen (2002) TNF-α 4.3 x 10-6 Pan (2002)
Transport Efficiency
More
Less
In situ brain uptake – measurement of rate of transport
Com
petit
ors""
OTCQX BIOAF TSX.V BTI
Independent 3rd party validation
Expand and protect
Intellectual Property portfolio
Advance internal
development programs
Collaborate with reputable pharmaceutical
companies
Corporate Strategy
13"
• Low-cost projects • Potential to achieve
major milestones: Short-Mid-Large Market Potential
• Many “shots on goal” leading to commercial transactions with numerous strong partners or licensees
• Over 30 patents granted relating to Transcend & Trancendpep for BBB delivery and neurodegenerative diseases
• National Research Council
• BC Cancer Research Centre
• Texas Tech University Health Sciences Center
OTCQX BIOAF TSX.V BTI
Development Programs
Completed 4 strategic collaborations on First Generation Transcend: • Shire HGT • AbbVie • MedImmune • UCB Pharmaceuticals
Second Generation Transcendpep: • MedImmune executed License Agreement • On-going discussion with AbbVie & UCB
Pharmaceuticals for licensing • Further discussions with large
pharmaceutical companies on licensing and research opportunities
14"
OTCQX BIOAF TSX.V BTI
Development Programs: Transcend + Anti-Amyloid Beta (“Aβ”) Antibody
Results !Transcend + anti-Aβ antibody conjugate increases transport into brain tissue by ~5-fold
0.000#
0.001#
0.002#
0.003#
0.004#
0.005#
0.006#
0.007#
Transcend3an43AB#mAb# an43Ab#mab#
Volume'Frac,o
n''' Parenchyma#
Quantitative Image Analysis by Laser Scanning Confocal Microscopy
15"
Alzheimer’s Disease Anti-Aβ antibodies have undergone clinical trials for treatment of Alzheimer’s disease Opportunity Using antibodies directed at Aβ are potential therapeutics for reducing amyloid plaques in the brain
National Research Council of Canada (NRC)
Anti-Aβ Transcend + Anti-Aβ
OTCQX BIOAF TSX.V BTI
Development Program:Transcend + α-L-iduronidase (“IDU”)
Lysosomal Storage Diseases Rare inherited metabolic diseases caused by an enzyme deficiency primarily affecting children
Hurler Syndrome (MPS I) Problem • MPS I is caused by an IDU deficiency • Currently CNS effects untreatable Results • Transcend + IDU (lysosomal enzyme)
conjugate increased IDU brain enzyme activity ~ 4-fold
Opportunity • Offers promise of an enzyme replacement
therapy 16"
0"
0.2"
0.4"
0.6"
0.8"
1"
1.2"
IDU Transcend-IDU
Total"IDU
"acOvity" Capillaries
Parenchyma
OTCQX BIOAF TSX.V BTI
Development Program:Transcend + iduronate-2-sulfatase (“IDS”)
Lysosomal Storage Diseases Rare inherited metabolic diseases caused by an enzyme deficiency primarily affecting children
Hunters Syndrome (MPS II) Problem • MPS II is caused by an IDS deficiency • Currently CNS effects untreatable Results • Transcend + IDS (lysosomal enzyme)
conjugate increased IDS brain enzyme activity ~ 20-fold
Opportunity • Offers promise of an enzyme replacement
therapy 17"
Native Enzyme
Transcend + IDS Enzyme
OTCQX BIOAF TSX.V BTI
Development Program: Transcend + Doxorubicin
• Doxorubicin is currently used as a cancer treatment (e.g. non-Hodgkin's lymphoma, multiple myeloma, acute leukemias, etc.)
Problem • Currently does not penetrate the BBB
Results • Significant INCREASE in brain uptake with
the Transcend + Doxorubicin conjugate VS Doxorubicin alone
Opportunity • Would be highly effective in treating
brain tumors if it could be delivered into the brain
18"
0.00"
1.00"
2.00"
3.00"
Transcend-Doxo Doxo
% INJECTED DOSE (G TISSUE/G BODY MASS)*100%
Transcend Significantly Enhances Doxorubicin Transport into the Brain
Conjugate retains full activity once released in the brain
OTCQX BIOAF TSX.V BTI
Transcend Significantly Reduces Doxorubicin Uptake into the Heart
Problem • Doxorubicin’s most serious
adverse effect is life-threatening heart damage
Results • Transcend + Doxorubicin VS
Doxorubicin on its own showed a significant DECREASE in uptake in the heart
Solution • Could be used to treat brain
cancers and decrease heart-uptake side effect, offering increased usage
19"
0.0"
5.0"
10.0"
15.0"
20.0"
Transcend-Doxo Doxo
% IN
JEC
TED
DO
SE
(gra
m b
rain
tiss
ue/g
ram
bod
y m
ass)
*100
OTCQX BIOAF TSX.V BTI
Development Program: Transcend + Trastuzumab (Herceptin®)
• Trastuzumab (Herceptin®)1 is a humanized monoclonal antibody used to treat HER2+ breast cancer
• Annual global sales ~$6.6 bn2
• Increases survival rate but ~40% patients eventually develop breast cancer metastasis in the brain3
• Trastuzumab (Herceptin®) does not cross the BBB
20"
1) Herceptin® is a registered trademark of Roche/Genentech 2) Company Reported Data – 2013 3) Britta Weigelt, Johannes L. Peterse & Laura J. van't Veer. (2005, August). Breast
cancer metastasis: markers and models. Nature Reviews Cancer 5 , 591-602.
Brain Capillaries
Cell Nuclei
BT2111: Transcend – Trastuzumab (Herceptin®)
Confocal Image Performed by iCapture at St. Paul’s Hospital Vancouver Canada
BT2111 Program: Transcend + Trastuzumab (Herceptin®) conjugate Confocal Images Two Hours Post IV Administration
OTCQX BIOAF TSX.V BTI
Reduced the number of HER2+ breast cancer tumors in the brain by 68%
The tumors that remained after treatment were 57% smaller
BT2111: Transcend + Trastuzumab (Herceptin®) In Vivo Efficacy in Breast Cancer Model
21"
…compared to those treated with Trastuzumab (Herceptin®) alone.
0"10"20"30"40"50"60"70"80"90"
Number of Tumors
0.0"
0.5"
1.0"
1.5"
2.0"
2.5"
Mean Tumor Volume
Transcend""(MTF"or"p97)"
mm
3!
OTCQX BIOAF TSX.V BTI
Development Program: Transcendpep + siRNA
Small Interfering RNA (siRNA) • Silences target genes • Nox4 is a gene associated with human diseases (i.e. cancers, neurodegenerative diseases, metabolic diseases, etc.)
Problem • siRNA does not cross the BBB • Gene targeting within the brain is currently unachievable Results • Transcendpep + siRNA conjugate delivered into the brain tissue • Demonstrated ~2 fold decrease in Nox4 signal VS siRNA
alone Opportunity • A potential cornerstone technology for the development of
new therapeutics suppressing disease-linked genes in the brain
22"
National Research Council
NO siRNA detected in Brain
Transcendpep + siRNA detected in Brain
OTCQX BIOAF TSX.V BTI
Highlights
23"
Transcend Family
“…would be the first carrier to efficaciously shuttle compounds across the BBB”
Discovery of Transcendpep
• Enhanced technology • Greater commercialization
potential
Company Profile
• Good cash position • Clean share structure • High internal ownership • Strong IR Program • Exit strategy in place
Management
Major success in: • Drug commercialization • Academia (BBB &
monoclonal antibodies) • Biotechnology & venture
capital startups
IP & Collaborations
• Full patent protection • Large pharmaceutical
collaborations • Positive results;
demonstrated efficacy
Large Market Opportunities
• Ability to extend patent life • Commercialize new
therapeutics and/or revitalize dormant candidates
• Contribute to the growth in CNS drug market
Treatment Potential
• Oncology • Metabolic diseases • Neurodegenerative diseases
…among others
OTCQX BIOAF TSX.V BTI
Timeline 2014-2015 Milestones Achieved ! Proof of principle
demonstrated ! Discovery of
Transcendpep -extended patent protection
! Strong pharmaceutical collaborations
! Completion of necessary financings
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Leader in providing shareholder value
Awarded TSX.V Top 50® "
Financing: TBD
Licensing: Transcendpep
Collaborations: New research and/or licensing agreements
External R&D: Development of New R&D Programs
Internal R&D BT2211 & LSD Programs Animal efficacy studies
Internal R&D Pre IND Toxicity Studies Proposed IND Filing
Evaluation: Exit strategies: Licensing / M&A
2014! 2015!
OTCQX BIOAF !TSX.V BTI July 2014