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biOasis Technologies, Inc. Investor Presentation, October 2014
Citation preview
A natural solution to!deliver medicines to!the brain!
OCTOBER !
2014!biOasis.ca!
OTCQX: BIOAF!TSX.V: BTI!
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.
2"
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.
OTCQX: BIOAF TSX.V: BTI
Central Nervous System Diseases
3"
1) (2012). Brain Facts; A Primer on the Brain and Nervous System . Publication, Society for Neuroscience. 2) (2007). Neurological disorders: Public health challenges . Study, UN World Health Organization . 3) bcc Research . (2010, September ). Therapeutic Drugs for Central Nervous System (CNS) Disorders: Technologies and Global Markets,
PHM068A.
AFFECTS 1 IN 6 PEOPLE !
ALL TREATMENTS HINDERED BY THE BLOOD BRAIN BARRIER !
12% of Global Deaths1
12% Increase by 20301
>1000 Different Diseases2
>$500 Billion US Market2
>$81.2 Billion Drug Market3
OTCQX: BIOAF TSX.V: BTI
"Challenge " The Blood Brain Barrier (“BBB”) Protective barrier of the central nervous system (“CNS”) preventing toxic compounds from entering the brain from the circulatory system
Problem BBB prevents therapeutics from entering the brain in efficacious levels
• ~98% of small molecule drugs • ~100% of large molecule drugs1
Solution • biOasis has discovered a natural occurring
physiological process that can transport therapeutics across the BBB
4"
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
What we do… Drug Delivery Platform Patented family of carriers, which delivers medicines across the BBB for the treatment of CNS diseases
Potential treatments for:
Market Leading Technology The Transcend Program
5"
Brain Cancers Metabolic Diseases
Neurodegenerative Diseases
OTCQX: BIOAF TSX.V: BTI
Breakthrough Solution
MTf • Known as Melanotransferrin (MTf or p97) • Human protein found at low concentrations in the
blood • Naturally delivers iron to the brain • Technology patented by the University of British
Columbia; later acquired by biOasis
6"
The Transcend Program A naturally occurring biological process that can be exploited to deliver therapeutics across the BBB and into the brain tissue to treat many neurological diseases and brain disorders
MTfp
• A newly discovered peptide found within the full length protein (MTf), which offers improved brain penetration and greater commercial potential
OTCQX: BIOAF TSX.V: BTI
Advantage of MTfp
! 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 MTfp
7"
BBB"
MTfp in Action
MTfp
Therapeutic
OTCQX: BIOAF TSX.V: BTI
Market Opportunities Major Unmet Medical Need 2014 Drug Market Estimates
8"
A carrier to cross the BBB would establish a foothold within these major markets
Central Nervous
System Disorders
!
Stroke & Traumatic Brain Injury Infection
Lysosomal !Storage Disease !
~$20 Billion �USD
~$81.2 Billion �USD
~$7.5 Billion �USD
>$1.9 Billion �USD
~$33.7 Billion �USD
~$138 Billion �USD
~$32.3 Psychiatry Billion �
USD Neurodegenerative
Disease" Clinical need met but
improved BBB
penetration could
increase efficacy
Pain & Migraine "
OTCQX: BIOAF TSX.V: BTI
Brain Cancer Market 2013 Drug Sales for Cancers, which frequently metastasize in the brain2
9"
1) GlobalData “Brain Tumor – Pipeline Assessment and Market Forecasts to 2017” released Jan. 17, 2011. 2) Company Reported Data
Herceptin® (trastuzumab) HER2+ Breast Cancer ~40% Metastasize
Taxol® (Paclitaxel) Lung, ovarian, etc. ~35% Metastasize
Rituxan® (Rituximab) Blood cancers: lymphoma, leukemia, etc. ~24% Metastasize
Erbitux® (Cetuximab) Lung cancer, colon cancer, etc.
~35% Metastasize
$6.6 Billion �USD
$7.5 Billion �USD
$1.9 Billion �USD
$92 Million �USD
Mai
n! Global Brain Tumour Therapies1
~$1.4 Billion �USD
OTCQX: BIOAF TSX.V: BTI
Business Opportunity
10"
Patent Cliff Estimated ~$250 billion in lost
revenue from patent expirations from 2012-20151
"
1) DeRuiter,"J.,"&"Holston,"P."L."(2012,"June"20)."Drug"Patent"ExpiraEons"and"the"“Patent"Cliff”."U.S."Pharm."2012;37(6)(Generic"suppl):12S20."
2) "(2007)."Neurological"disorders:"Public"health"challenges"."Study,"UN"World"Health"OrganizaEon"."
hZp://www.un.org/apps/news/story.asp?newsid=21689&cr=neurological#.U7iNnBa4klI"
3) (2012)."Brain"Facts;"A"Primer"on"the"Brain"and"Nervous"System"."PublicaEon,"Society"for"Neuroscience."
Market Growth CNS Drug Market worth over
$81.2 billion USD and growing at 12% CAGR (2012-2030)3
"
Unmet Medical Need Over 1000 unique CNS diseases with treatments hindered by drug
delivery across the BBB2
"
Offers the potential for patent term extensions through New Chemical Entity (“NCE”) on
many preexisting drugs
Aid in the development of new therapies and revitalize dormant
candidates that are proven efficacious but do not cross
Contribute CNS drug market by opening up an industry that has been stagnated by ineffective
brain drug delivery
OTCQX: BIOAF TSX.V: BTI
Who we are…
Board of Directors Rob Hutchison, Chair & CEO Former: CEO & Chief Scientist at eCharge Corporation Chris Fibiger, PhD Former: Head of Neuroscience, Amgen; VP Neuroscience, Eli Lily & CSO, Biovail Laboratories Greg Gubitz, LLB Former: VP, Biovail Corporation & COO, MDS Capital Terry Pearson, PhD Professor: Biochemistry & Microbiology, UVIC Ron Erickson Current: Chair & CEO, Visulant Technologies Michael Hutchison, QC, LLB Partner, Smith Hutchison Law Corporation
Team
Judi Dalling, LLB, CFO Seasoned public company CFO and corporate lawyer Wilfred Jefferies, PhD, Founding Scientist Oxford University, Molecular Immunology Discovered p97’s ability to cross the BBB Professor: Microbiology & Immunology, UBC Reinhard Gabathuler, PhD, Chief Scientist Former: VP Brain Research, Biomarin & CSO, Angiochem Inc. Mei Mei Tian, PhD, Scientist UBC, Microbiology and Immunology (p97 expertise) Laura Ho, MSc, Scientist UBC, Microbiology and Immunology Tiffany Tolmie, Communications Honours, Wilfrid Laurier University
OTCQX: BIOAF TSX.V: BTI
Independent 3rd party validation
Expand & protect
Intellectual Property
Advance internal
development programs
Collaborate with reputable pharmaceutical
companies
Corporate Strategy
12"
• Low-cost projects • Potential to achieve
major milestones: " Short-Mid-Large
Market Potential
• Many “shots on goal” leading to commercial transactions with numerous partners/licensees
• Over 30 patents granted for BBB delivery and neurodegenerative diseases
• National Research Council
• BC Cancer Research Centre
• Texas Tech University Health Sciences Center
• Southern Research Institute
• University of Alabama
OTCQX: BIOAF TSX.V: BTI
Collaborations
Strategic Collaborations
• AbbVie • MedImmune • UCB Pharmaceuticals
MTfp • MedImmune executed License Agreement • On-going discussions with collaborators for
licensing agreements • Further discussions with large pharmaceutical
companies on licensing and research opportunities
13"
OTCQX: BIOAF TSX.V: BTI
MTf: Rapid Uptake in Brain
14"
Compound Brain Kin (mL-1/s-1/
g-1)
Reference
Glucose 9.5 x 10-3 Smith (2003) Melanotransferrin (MTf) ! 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
Development Programs: "MTf + Anti-Aβ antibody
Results MTf + anti-Aβ antibody conjugate increases transport into brain tissue by ~5-fold
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 MTf + Anti-Aβ
OTCQX: BIOAF TSX.V: BTI
Development Program:"MTf + 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 • MTf + 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 MTf - IDU
Total"IDU"acEvity" Capillaries
Parenchyma
OTCQX: BIOAF TSX.V: BTI
Development Program:"MTf + 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 • MTf + IDS (lysosomal enzyme) conjugate
increased IDS brain enzyme activity ~20-fold Opportunity • Offers promise of an enzyme replacement
therapy
17"
MTf+ IDS Enzyme enters the brain tissue
Native Enzyme does not enter the brain tissue efficaciously
OTCQX: BIOAF TSX.V: BTI
Development Program: "MTf + Doxorubicin
• Doxorubicin is currently used as a cancer treatment (e.g. breast, bladder, lung, ovaries, stomach, thyroid, multiple myeloma, leukemias and Hodgkin's lymphoma)
Problem • Currently does not penetrate the BBB
Results • Significant INCREASE in brain uptake with
the MTf + 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"
MTf + DOXO DOXO
% INJECTED DOSE (G TISSUE/G BODY MASS)*100%
MTf Significantly Enhances Doxorubicin Transport into the Brain
Conjugate retains full activity once released in the brain
OTCQX: BIOAF TSX.V: BTI
MTf Significantly Reduces Doxorubicin Uptake into the Heart Problem • Doxorubicin’s most serious adverse
effect is life-threatening heart damage
Results • MTf + 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"
% IN
JEC
TED
DO
SE
(gra
m b
rain
tiss
ue/g
ram
bod
y m
ass)
*100
MTf + DOXO DOXO
OTCQX: BIOAF TSX.V: BTI
Development Program: "MTf + Trastuzumab (Herceptin®)
• Trastuzumab (Herceptin®)1 is a humanized monoclonal antibody used to treat HER2+ breast cancer
• Annual global sales ~$6.6 bn2
• Herceptin® 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
MTf + Trastuzumab (Herceptin®)
Confocal Image Performed by iCapture at St. Paul’s Hospital Vancouver Canada
MTf + Trastuzumab (Herceptin®) 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%
MTf + Trastuzumab (Herceptin®) "In Vivo Efficacy in Breast Cancer Model
21"
0"10"20"30"40"50"60"70"80"90"
MTf " " TZM " MTf-TZM " Saline "" " " " " " Control !
Number of Tumors
Additional Highlights: • The tumors that remained after
treatment had 57% smaller tumour volume
• Penetrated the Blood Tumour Barrier 10 times better than Herceptin® alone
• Increased cancer killing effect of Herceptin® when linked with MTf
OTCQX: BIOAF TSX.V: BTI
Development Program: "MTfp + siRNA
Small Interfering RNA (siRNA) • Silences target gene expression • Targeted 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 • MTf+ siRNA conjugate delivered into the brain tissue • Demonstrated 40% to 50% decrease in target gene 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
MTf + siRNA detected in Brain
OTCQX: BIOAF TSX.V: BTI
Market Profile "
23"
Data source: S&P Capital IQ Trailing twelve months as of May 2014 Shares – September 3, 2014
TSX.V:BTI; OTCQX:BIOAF Shares Issued & Outstanding 43,805,507 Fully Diluted 51,605,609 Options 5,855,625
Directors, officers & employees
Warrants 1,944,477 IP Warrants
Market Cap ~$52.7m @ $1.20 Share Price (Sept. 3, 2014)
Cash Position ~$3m (May 2014 Financials + August 2014 Financing)
Ownership Insiders & Affiliates ~35% Institutional ~10%
OTCQX: BIOAF TSX.V: BTI
24"
Pipeline Brain
Transport Brain
Quantification Cellular
Localization PD Models
Efficacy
Onc
olog
y Doxorubicin
[Gliomas] Paclitaxel [Tumours] Herceptin [Breast Cancer] Cetuximab [Lung Cancer]
LSD Hurlers Syndrome
MPS l Model Hunters Syndrome MPS II Model Sandhoff and Tay- Sacs Disease Hexosaminidase B Model
siRNA
Stroke Model
ALS Model
OTCQX: BIOAF TSX.V: BTI
Summary
25"
!Intellectual Property
& Collaborations
Strong patent protection Patent portfolio of >30 patents
Large pharmaceutical collaborations
Positive results; successful demonstration
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
Metabolic diseases Neurodegenerative
diseases Oncology
"
Awarded TSX.V Top 50® in 2013
Leader in providing shareholder value
Market Profile
Good cash position Clean share structure Exit strategy in place
High internal ownership
Management
Major success in: Drug commercialization Biotechnology & venture
capital startups Academia
"
Transcend Program
“The first natural carrier to effectively
transport therapeutic drugs into the brain.”
Discovery of MTfp
Enhanced technology Greater commercial
potential "