25
A natural solution to deliver medicines to the brain OCTOBE 2014 biOasis.ca OTCQX: BIOAF TSX.V: BTI

biOasis Technologies, Inc. Presentation - October 2014

Embed Size (px)

DESCRIPTION

biOasis Technologies, Inc. Investor Presentation, October 2014

Citation preview

Page 1: biOasis Technologies, Inc. Presentation - October 2014

A natural solution to!deliver medicines to!the brain!

OCTOBER !

2014!biOasis.ca!

OTCQX: BIOAF!TSX.V: BTI!

Page 2: biOasis Technologies, Inc. Presentation - October 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.

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.

Page 3: biOasis Technologies, Inc. Presentation - October 2014

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

Page 4: biOasis Technologies, Inc. Presentation - October 2014

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

Page 5: biOasis Technologies, Inc. Presentation - October 2014

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

Page 6: biOasis Technologies, Inc. Presentation - October 2014

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

Page 7: biOasis Technologies, Inc. Presentation - October 2014

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

Page 8: biOasis Technologies, Inc. Presentation - October 2014

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 "

Page 9: biOasis Technologies, Inc. Presentation - October 2014

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

Page 10: biOasis Technologies, Inc. Presentation - October 2014

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

Page 11: biOasis Technologies, Inc. Presentation - October 2014

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

Page 12: biOasis Technologies, Inc. Presentation - October 2014

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

Page 13: biOasis Technologies, Inc. Presentation - October 2014

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"

Page 14: biOasis Technologies, Inc. Presentation - October 2014

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""

Page 15: biOasis Technologies, Inc. Presentation - October 2014

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

Page 16: biOasis Technologies, Inc. Presentation - October 2014

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

Page 17: biOasis Technologies, Inc. Presentation - October 2014

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

Page 18: biOasis Technologies, Inc. Presentation - October 2014

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

Page 19: biOasis Technologies, Inc. Presentation - October 2014

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

Page 20: biOasis Technologies, Inc. Presentation - October 2014

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

Page 21: biOasis Technologies, Inc. Presentation - October 2014

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

Page 22: biOasis Technologies, Inc. Presentation - October 2014

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

Page 23: biOasis Technologies, Inc. Presentation - October 2014

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%

Page 24: biOasis Technologies, Inc. Presentation - October 2014

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

Page 25: biOasis Technologies, Inc. Presentation - October 2014

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 "