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OTCQX BIOAF TSX.V BTI July 2014

biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

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Page 1: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQ

X BIOAF !

TSX.V BTI July 2014

Page 2: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Forward Looking Statem

ents Certain statem

ents in this press release contain forward-looking statem

ents within the m

eaning of the Private Securities Litigation Reform

Act of 1995 or forward-looking inform

ation under applicable Canadian securities legislation that may not

be based on historical fact, including without lim

itation statements containing the w

ords “believe”, “may”, “plan”, “w

ill”, “estim

ate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Such forw

ard-looking statements or

information involve know

n and unknown risks, uncertainties and other factors that m

ay cause our actual results, events or developm

ents, or industry results, to be materially different from

any future results, events or developments express or

implied by such forw

ard-looking statements or inform

ation.

Such factors include, among others, our stage of developm

ent, lack of any product revenues, additional capital requirem

ents, risk associated with the com

pletion 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 arrangem

ents and their timing. Specifically, certain risks and

uncertainties that could cause such actual events or results expressed or implied by such forw

ard-looking statements and

information to differ m

aterially from any future events or results expressed or im

plied by such statements and inform

ation include, but are not lim

ited to, the risks and uncertainties that: products that we develop m

ay 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; w

e may not be able to raise additional capital; w

e may not be successful in establishing additional corporate

collaborations or licensing arrangements; w

e may not be able to establish m

arketing and the costs of launching our products m

ay be greater than anticipated; we have no experience in com

mercial m

anufacturing; we m

ay face unknown

risks related to intellectual property matters; w

e face increased competition from

pharmaceutical and biotechnology

companies; and other factors as described in detail in our filings w

ith the Canadian securities regulatory authorities at w

ww.sedar.com

.

Given these risks and uncertainties, you are cautioned not to place undue reliance on such forw

ard-looking statements

and information, w

hich are qualified in their entirety by this cautionary statement. All forw

ard-looking statements and

information m

ade herein are based on our current expectations and we undertake no obligation to revise or update such

forward- looking statem

ents and information to reflect subsequent events or circum

stances, except as required by law.

2"

Page 3: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Market Profile

OTCQ

X: BIOAF; TSX.V: BTI

3"

Data source: S&P Capital IQ Trailing tw

elve 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 & em

ployees

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)

Ow

nership!Insiders & Affiliates ~35%

!Institutional ~10%

!

Page 4: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Who w

e are…

Board of Directors Rob Hutchison, Chair & CEO!Form

er: CEO & Chief Scientist at eCharge Corporation

(World’s First Internet Paym

ent System)

Chris Fibiger, PhD !Form

er: Head of Neuroscience, Amgen; VP Neuroscience, Eli Lily &

CSO, Biovail Laboratories !G

reg Gubitz, LLB!

Former: VP, Biovail Corporation (m

erged Valeant Pharmaceuticals)

COO, M

DS Capital (Life Science VC firm $1bn under m

anagement)

Terry Pearson, PhD!Professor: Biochem

istry & Microbiology, UVIC

Bench-mates: Nobel Laureate, Dr. G

eorge Kohler (monoclonal antibody)

Discovered & comm

ercialized highly- successful SISCAPA Assay Technology !!Ron Erickson !O

ver 30 years experience: attorney & senior level executive Current: Chair & CEO, Visulant Technologies (nano-photonics com

pany) M

ichael 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 !W

ilfred Jefferies, PhD, Founding Scientist !O

xford University, Molecular Im

munology

Discovered p97’s ability to cross the BBB & Ox26 (foundational

antibody for BBB research) Professor: M

icrobiology & Imm

unology, UBC !Reinhard G

abathuler, PhD, Chief Scientist!University of Lausanne, Switzerland, Plant Biochem

istry O

ver 25 years experience, academic research & early-stage biotech

companies

Former: VP Brain Research, Biom

arin & CSO, Angiochem Inc.

!Mei M

ei Tian, PhD, Scientist !UBC, M

icrobiology and Imm

unology Expertise in BBB transport, cell biology, m

olecular biology !Laura Ho, M

Sc, Scientist !UBC, M

icrobiology and Imm

unology !Tiffany Tolm

ie, Corporate Comm

unications !Honours, W

ilfrid Laurier University

Page 5: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

What w

e do…

Brain Delivery Platform Patented “Transcend Fam

ily” of technologies allow

s drug therapies to penetrate the Blood-Brain Barrier (“BBB”) to treat diseases of the Central Nervous System

(“CNS”) Potential treatm

ents for:

Market Lead

ing Techno

logy

Transcend & Transcendpep !

5"

Oncology

Metabolic

Diseases Neurodegenerative

Diseases

Page 6: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

The Blood-Brain Barrier Challenge

Blood Brain Barrier Protective barrier of the CNS preventing toxic com

pounds from entering the brain from

the circulatory system

Problem BBB prevents therapeutics from

entering the brain • 

~98% of sm

all molecule drugs

• ~100%

of large molecule drugs 1

Solution Discovering a ‘carrier’ to deliver therapeutic treatm

ents across the BBB

i. O

pportunity to extend patent life of existing drug therapies ii. 

Contribute to the growth in CNS drug m

arket and revitalize dorm

ant candidates iii. 

Assist development of new

therapies for currently untreatable diseases

6"

1) Royal Society of Chemistry

Tightly"woven"capillary"netw

ork"of"endothelial"cells"lining"the"blood"vessels"in"the"brain,"w

hich"is"responsible"for"maintaining"hom

eostasis"

Page 7: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Breakthrough Solution

First Generation: Transcend • Know

n as Melanotransferrin (M

Tf or p97) • Native hum

an protein found at low

concentrations in the blood • Technology patented at University of British

Columbia; later purchased by biO

asis

7"

The Transcend Family

…is a naturally occurring physiological transport m

echanism

… acts as a ‘Trojan-Horse’ to transport therapeutics across the BBB and into the brain tissue

Second Generation: Transcendpep

• A newly discovered peptide found w

ithin Transcend, w

hich offers improved brain

penetration over Transcend

Page 8: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Advantage of Transcendpep

� G

reater efficiency of BBB delivery

� Low

er cost of production � Im

proved quality control � Sim

pler to link to therapeutics � Transports a variety of com

pounds w

ith no apparent size limitation

� Extends biO

asis patent portfolio � Pharm

aceutical collaborators currently licensing Transcend

pep

8"

BBB"

Transcendpep

Therapeutic

Transcendpep in Action

Page 9: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Market O

pportunities M

ajor Unmet M

edical Needs Drug m

arket limited by the BBB

9"

A carrier to

cro

ss the B

BB

would

estab

lish a fo

otho

ld

within these

majo

r m

arkets

Central Nervous System

~$81.2bn

Neuro-degenerative

Diseases

~$20bn

!

Stroke & Traum

atic Brain Injury

~$7.5bn

Pain & M

igraine ~$33.7bn

2014 Estimates in $U

SD

Clinical need m

et but im

proved BBB penetration could increase effi

cacy

Psychiatry

~$32.3bn

Infection (B

acte

rial, V

iral, F

ungal)

~$138bn

Lysosomal

Storage Disease !

>$1.9bn

Page 10: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Brain Cancer Market

Sales for Current Cancer Therapeutics Treatm

ents for cancers, which frequently m

etastasize in the brain, Do Not cross the BBB in efficacious levels

10"

1) GlobalData “Brain Tum

or – Pipeline Assessment and M

arket Forecasts to 2017” released Jan. 17, 2011. 2) Com

pany 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 Tum

or Therapies Market 1

Herceptin®

(trastuzumab)

HER2+ Breast Cancer

Rituxan®

(Rituximab)

lymphom

as, leukem

ias

Taxol®

(Paclitaxel) lung, ovarian,

etc.

Erbitux®

(Cetuximab)

Metastatic

colon cancer, etc.

$9

2 m

illion in

sales 20

13

2

$7

.5 b

illion in

sales 20

13

2

$1

.9 b

illion in

sales 20

13

2

$6.6

billio

n in sales 2013

2

Results Trancend + Trastuzum

ab (Herceptin®

) conjugate not only crossed the BBB but increased cancer killing activities throughout the body

3

Opportunity Potential to increase effectiveness of cancer therapeutics and treat tum

ours that metastasize

in the brain

$1.4 billion Market in 2013

Page 11: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Multiple Developm

ent Opportunities

Conjugated with Transcend:

• Antibodies • Enzym

es • Biologics agents • Sm

all molecules drugs

Targeting:

11"

Patent Cliff Estim

ated ~$250 billion in lost revenue from

patent expiration betw

een 2012-20151

Transcend family linked w

ith existing drugs offers the potential for patent term

extensions through New

Chemical Entity (“NCE”)

"

Specific brain cells (e.g., neurons, astrocytes and glia)

Intracellular compartm

ents (e.g., lysosom

es, endosomes,

mitochondria)

Delivery into the brain of existing therapeutic drugs currently not approved for CNS indications

Delivery into the brain of prom

ising new agents in developm

ent

"""

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.""

Page 12: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

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-G

lucuronide 2.4 x 10

-5 Tem

samani 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 Effi

ciency

More

Less

In situ brain uptake – measurem

ent of rate of transport

Competitors""

Page 13: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Independent 3rd party validation

Expand and protect

Inte

llectu

al

Pro

perty

portfolio

Advance internal

development

programs

Collaborate w

ith reputable pharm

aceutical com

panies

Corporate Strategy

13"

• Low

-cost projects • 

Potential to achieve m

ajor milestones:

Short-Mid-Large

Market Potential

• M

any “sho

ts on

go

al” leading to

comm

ercial transactions w

ith num

erous strong partners or licensees

• O

ver 30 patents granted relating to Transcend & Trancend

pep for BBB delivery and neurodegenerative diseases

• National Research Council

• BC Cancer Research Centre

• Texas Tech University Health Sciences Center

Page 14: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Development Program

s

Completed 4 strategic collaborations on

First Generation Transcend: • Shire HG

T • AbbVie • M

edImm

une • UCB Pharm

aceuticals

Second Generation Transcendpep:

• MedIm

mune executed License Agreem

ent • O

n-going discussion with AbbVie & UCB

Pharmaceuticals for licensing

• Further discussions with large

pharmaceutical com

panies on licensing and research opportunities

14"

Page 15: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Development Program

s: Transcend + Anti-Am

yloid 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,on'''

Parenchyma#

Quantitative Im

age Analysis by Laser Scanning C

onfocal Microscopy

15"

Alzheimer’s Disease

Anti-Aβ antibodies have undergone clinical trials for treatm

ent of Alzheimer’s

disease Opportunity Using antibodies directed at Aβ are potential therapeutics for reducing am

yloid plaques in the brain

National Research Council of Canada (NRC)

Anti-Aβ Transcend + Anti-Aβ

Page 16: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Development Program

:Transcend + α

-L-iduronidase (“IDU”)

Lysosomal Storage Diseases

Rare inherited metabolic diseases caused by an

enzyme deficiency prim

arily affecting children

Hurler Syndrome (M

PS I) Problem • M

PS I is caused by an IDU deficiency • Currently CNS effects untreatable Results • Transcend + IDU (lysosom

al enzyme)

conjugate increased IDU brain enzyme

activity ~ 4

-fold Opportunity • Offers prom

ise of an enzyme replacem

ent therapy

16"

0"

0.2"

0.4"

0.6"

0.8"

1"

1.2"

IDU Transcend-IDU

Total"IDU"acOvity"

Capillaries Parenchym

a

Page 17: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Development Program

:Transcend + iduronate-2-sulfatase (“IDS”)

Lysosomal Storage Diseases

Rare inherited metabolic diseases caused by an

enzyme deficiency prim

arily affecting children

Hunters Syndrome (M

PS II) Problem • M

PS II is caused by an IDS deficiency • Currently CNS effects untreatable Results • Transcend + IDS (lysosom

al enzyme)

conjugate increased IDS brain enzyme

activity ~ 2

0-fold

Opportunity • Offers prom

ise of an enzyme replacem

ent therapy

17"

Native Enzym

e

Transcend + IDS Enzym

e

Page 18: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Development Program

: Transcend + Doxorubicin

• Doxorubicin is currently used as a cancer treatm

ent (e.g. non-Hodgkin's

lymphom

a, multiple m

yeloma, acute leukem

ias, etc.)

Problem

• Currently does not penetrate the BBB

Results • Significant INCREASE in brain uptake w

ith the Transcend + Doxorubicin conjugate VS Doxorubicin alone

Opportunity • W

ould be highly effective in treating brain tum

ors if it could be delivered into the brain

18"

0.00"

1.00"

2.00"

3.00"

Transcend-Doxo

Doxo

% IN

JECTED

DO

SE (G

TISSUE/G

BOD

Y MASS)*100%

Transcend Significantly Enhances D

oxorubicin Transport into the Brain

Conjugate

retains full activity once released in the brain

Page 19: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Transcend Significantly Reduces Doxorubicin Uptake into the Heart

Problem

• Doxorubicin’s most serious

adverse effect is life-threatening heart dam

age

Results • Transcend + Doxorubicin V

S Doxorubicin on its ow

n 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

% INJECTED DOSE (gram brain tissue/gram body mass)*100

Page 20: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Development Program

: Transcend + Trastuzum

ab (Herceptin®)

• Trastuzumab (Herceptin®

) 1 is a hum

anized monoclonal antibody

used to treat HER2+ breast cancer • Annual global sales ~$6.6 bn

2

• Increases survival rate but ~40%

patients eventually develop breast cancer m

etastasis in the brain3

• Trastuzumab (Herceptin®

) does not cross the BBB

20"

1) Herceptin® is a registered tradem

ark of Roche/Genentech

2) Company Reported Data – 2013

3) Britta Weigelt, Johannes L. Peterse & Laura J. van't Veer. (2005, August). Breast

cancer metastasis: m

arkers and models. Nature Review

s Cancer 5 , 591-602.

Brain Capillaries

Cell N

uclei

BT2111: Transcend – Trastuzum

ab (Herceptin®

)

Confocal Image Perform

ed by iCapture at St. Paul’s Hospital Vancouver C

anada

BT2111 Program: Transcend +

Trastuzumab (H

erceptin®) conjugate

Confocal Im

ages Two H

ours Post IV Administration

Page 21: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Reduced the number of HER2+ breast

cancer tumors in the brain by 6

8%

The tumors that rem

ained after treatm

ent were 5

7%

smaller

BT2111: Transcend + Trastuzumab (Herceptin®

) In Vivo Effi

cacy in Breast Cancer Model

21"

…com

pared to those treated with Trastuzum

ab (Herceptin®

) alone.

0"10"20"30"40"50"60"70"80"90"

Num

ber of Tumors

0.0"

0.5"

1.0"

1.5"

2.0"

2.5"

Mean Tum

or Volume

Transcend""(MTF"or"p97)"

mm3!

Page 22: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Development Program

: Transcend

pep + siRNA

Small Interfering RNA (siRNA)

• Silences target genes • Nox4 is a gene associated w

ith human diseases

(i.e. cancers, neurodegenerative diseases, metabolic diseases, etc.)

Problem • siRNA does not cross the BBB • G

ene targeting within the brain is currently unachievable

Results • Transcend

pep + siRNA conjugate delivered into the brain tissue • Dem

onstrated ~2 fold decrease in Nox4 signal VS siRNA

alone Opportunity • A potential cornerstone technology for the developm

ent of new

therapeutics suppressing disease-linked genes in the brain

22"

National Research Council

NO

siRNA detected in Brain

Transcendpep + siRN

A detected in Brain

Page 23: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Highlights

23"

Transcend Family

“…w

ould

be the first carrier to

efficacio

usly shuttle co

mpound

s across the B

BB

” Discovery of Transcend

pep

• Enhanced technology

• G

reater comm

ercialization potential

Company Profile

• G

ood cash position • 

Clean share structure • 

High internal ownership

• Strong IR Program

• 

Exit strategy in place

Managem

ent M

ajo

r success in:

• Drug com

mercialization

• Academ

ia (BBB & m

onoclonal antibodies) • 

Biotechnology & venture capital startups

IP & Collaborations • 

Full patent protection • 

Large pharmaceutical

collaborations • 

Positive results; dem

onstrated efficacy

Large Market Opportunities

• Ability to extend patent life

• Com

mercialize new

therapeutics and/or revitalize dorm

ant candidates • 

Contribute to the growth in

CNS drug market

Treatment Potential

• O

ncology • 

Metabolic diseases

• Neurodegenerative diseases …

among others

Page 24: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQX BIOAF TSX.V BTI

Timeline 2014-2015

Milestones Achieved

! Proof of principle dem

onstrated ! Discovery of Transcend

pep -extended patent protection

! Strong pharm

aceutical collaborations

! Com

pletion of necessary financings

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Leader in providing shareholder value

Aw

arded

TS

X.V

To

p 5

"

Financing: TBD

Licensing: Transcendpep

Collaborations: New

research and/or licensing agreements

External R&D: Developm

ent of New

R&D

Programs

Internal R&D B

T2211 & LSD Program

s Anim

al efficacy studies

Internal R&D Pre IN

D Toxicity Studies

Proposed IND

Filing

Evaluation: Exit strategies:

Licensing / M&A

2014!2015!

Page 25: biOasis Technologies, Inc. (BTI.TSXV & BIOAF.OTCQX) Presentation - July 2014

OTCQ

X BIOAF !

TSX.V BTI July 2014