This document discusses biOasis Technologies Inc., a company developing a drug delivery platform to transport therapeutics across the blood-brain barrier (BBB) for treating central nervous system diseases. The platform utilizes melanotransferrin (MTf), a human protein that naturally transports iron into the brain. BiOasis has discovered a peptide within MTf, called MTfp, that offers improved brain penetration. Studies show MTf and MTfp conjugated to various compounds, including antibodies, enzymes and chemotherapy drugs, significantly increase transport into the brain compared to the compounds alone. BiOasis is working to validate and expand this technology with the goal of developing treatments for diseases like Alzheimer's, lysosomal storage disorders and brain cancer.
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biOasis Technologies, Inc. Presentation - October 2014
1. A natural solution to!
deliver medicines to!
the brain!
OCTOBER!
OTCQX: BIOAF!
TSX.V: BTI!
biOasis.ca!2014!
2. 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 âbelieveâ, âmayâ, âplanâ, âwillâ, âestimateâ, âcontinueâ,
âanticipateâ, âintendâ, âexpectâ 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.
3. ALL TREATMENTS HINDERED BY THE BLOOD BRAIN BARRIER 12% of Global
>$81.2 Billion Drug
OTCQX: BIOAF
TSX.V: BTI
Central Nervous System Diseases
3"
AFFECTS 1 IN 6 PEOPLE !
Deaths1
12% Increase by
20301
>1000 Different
Diseases2
>$500 Billion US
Market2
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.
Market3
4. OTCQX: BIOAF
TSX.V: BTI
"
Challenge "
The Blood Brain Barrier (âBBBâ)
Protective barrier of the central nervous system
(âCNSâ) 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
5. OTCQX: BIOAF
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What we doâŚ
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
6. OTCQX: BIOAF
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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
7. OTCQX: BIOAF
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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"
MTfp in Action
BBB"
MTfp
Therapeutic
8. OTCQX: BIOAF
TSX.V: BTI
Market Opportunities
Major Unmet Medical Need
2014 Drug Market Estimates
8"
Central Nervous
System
Disorders
!
Stroke &
Traumatic
Brain Injury
Psychiatry
A carrier to cross the BBB would establish a
foothold within these major markets
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
Billion #
USD
Neurodegenerative
Disease" Clinical
need met but
improved
BBB
penetration
could
increase
efficacy
Pain &
Migraine
"
9. OTCQX: BIOAF
TSX.V: BTI
Brain Cancer Market
2013 Drug Sales for Cancers, which frequently
metastasize in the brain2
9"
HerceptinÂŽ (trastuzumab)
HER2+ Breast Cancer
~40% Metastasize
RituxanÂŽ (Rituximab)
Blood cancers: lymphoma, leukemia, etc.
~24% Metastasize
ErbituxÂŽ (Cetuximab)
Lung cancer, colon cancer, etc.
~35% Metastasize
TaxolÂŽ (Paclitaxel)
Lung, ovarian, etc.
~35% Metastasize
1) GlobalData âBrain Tumor â Pipeline Assessment and Market Forecasts to 2017â released Jan. 17, 2011.
2) Company Reported Data
$6.6
Billion #
USD
$7.5
Billion #
USD
$1.9
Billion #
USD
$92
Million #
USD
Main!
Global Brain Tumour
Therapies1
~$1
.4
Billion #
USD
10. OTCQX: BIOAF
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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"âPatent"Cliffâ."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 (âNCEâ) 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
11. OTCQX: BIOAF
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Who we areâŚ
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 p97âs 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
12. OTCQX: BIOAF
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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 âshots on goalâ
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
13. OTCQX: BIOAF
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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"
14. OTCQX: BIOAF
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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-Îą
4.3 x 10-6
Pan (2002)
More
Transport
Efficiency
Less
In Situ Brain Uptake â Measurement of Rate of Transport
Competitors""
15. OTCQX: BIOAF
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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"
Alzheimerâs Disease
Anti-Aβ antibodies have
undergone clinical trials for
treatment of Alzheimerâs
disease
Opportunity
Using antibodies directed at
Aβ are potential therapeutics
for reducing amyloid plaques
in the brain
MTf + Anti-AβAnti-Aβ
National Research Council of Canada
(NRC)
16. OTCQX: BIOAF
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Development Program:"
MTf + Îą-L-iduronidase (âIDUâ)
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"
1.2"
1"
0.8"
0.6"
0.4"
0.2"
0"
Parenchyma
IDU
MTf - IDU
Total"IDU"acEvity"
Capillaries
17. Native Enzyme does not enter the brain tissue efficaciously
OTCQX: BIOAF
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Development Program:"
MTf + iduronate-2-sulfatase (âIDSâ)
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
18. MTf Significantly Enhances
Doxorubicin Transport into the Brain
(G TISSUE/G BODY MASS)*100%
Conjugate retains full
activity once released
in the brain
OTCQX: BIOAF
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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"
3.00"
2.00"
1.00"
0.00"
% INJECTED DOSE
MTf + DOXO DOXO
19. OTCQX: BIOAF
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MTf Significantly Reduces Doxorubicin
Uptake into the Heart
Problem
⢠Doxorubicinâs 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"
20.0"
15.0"
10.0"
5.0"
0.0"
(gram brain tissue/gram body
% INJECTED DOSE
mass)*100
MTf + DOXO DOXO
20. MTf + Trastuzumab (HerceptinÂŽ)
Confocal Images Two Hours Post IV Administration
OTCQX: BIOAF
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Development Program: "
MTf + Trastuzumab (HerceptinÂŽ)
⢠Trastuzumab (HerceptinŽ)1 is a
humanized monoclonal antibody
used to treat HER2+ breast cancer
⢠Annual global sales ~$6.6 bn2
⢠HerceptinŽ increases survival rate
but ~40% patients eventually
develop breast cancer metastasis in
the brain3
⢠Trastuzumab (HerceptinŽ) does not
cross the BBB
20"
1) HerceptinÂŽ is a registered trademark of Roche/Genentech
2) Company Reported Data â 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 (HerceptinÂŽ)
Confocal Image Performed by iCapture at
St. Paulâs Hospital Vancouver Canada
21. OTCQX: BIOAF
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MTf + Trastuzumab (HerceptinÂŽ) "
In Vivo Efficacy in Breast Cancer Model
Reduced the number of HER2+ breast
cancer tumors in the brain by 68%
21"
90"
80"
70"
60"
50"
40"
30"
20"
10"
0"
Number of Tumors
MTf " " TZM " MTf-TZM " Saline "
" " " " " " Control !
Additional Highlights:
⢠The tumors that remained after
treatment had 57% smaller
tumour volume
⢠Penetrated the Blood Tumour
Barrier 10 times better than
HerceptinÂŽ alone
⢠Increased cancer killing effect of
HerceptinÂŽ when linked with
MTf
22. NO siRNA detected in Brain
MTf + siRNA detected in Brain
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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
23. OTCQX: BIOAF
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Market Profile "
23"
TSX.V:BTI; OTCQX:BIOAF
Shares Issued & Outstanding
Data source: S&P Capital IQ
Trailing twelve months as of May 2014
Shares â September 3, 2014
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%
24. OTCQX: BIOAF
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24"
Pipeline
Brain
Transport
Brain
Quantification
Cellular
Localization
PD Models
Efficacy
Oncology
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
25. Intell e!ctual
Property
& Collaborations
Strong patent protection
Patent portfolio of >30 patents
OTCQX: BIOAF
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Summary
25"
Large pharmaceutical
collaborations
Positive results;
successful demonstration
Market Profile
Good cash position
Clean share structure
Exit strategy in place
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
"
Management
Major success in:
Drug commercialization
Biotechnology & venture
capital startups
Academia
Awarded TSX.V Top
50ÂŽ in 2013
High internal
ownership
Leader in providing shareholder value
"
Transcend
Program
âThe first natural
carrier to effectively
transport therapeutic
drugs into the brain.â
Discovery
of MTfp
Enhanced technology
Greater commercial
potential
"