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www.fortisoncology.com

INVESTOR PRESENTATION

10/31/2013
FORTIS ONCOLOGY:
NANOTHERMAL MEDICAL DEVICE PRODUCTS TO
ERADICATE CANCER
CANCER TODAY
THE COST OF CANCER IS
HIGH.
EACH OF US HAS
BEEN
TOUCHED
WITH
CANCER IN OUR LIVES; A
MOTHER, FATHER, SIBLING,
FRIEND. IT IS A LARGE AND
GROWING
MARKET
AND
HUGE
HEALTHCARE
ECONOMIC BURDEN

Worldwide, there are more than
12.5M new cancer diagnoses each
year, and that figure continues to
climb.

The total cost of cancer have been
estimated to be as high as $895
billion (US) worldwide. http://www.cancer.org/

10/31/2013

3
OUR MISSION
To bring advanced,
nanothermal products to
market approval that not
only destroy cancer, but
spare healthy tissue,
without the side effects
seen in conventional
therapies and in doing so,
build a sustainable,
profitable business.
Confidential

10/31/2013

4
HISTORY OF NANOFORTIS
ONCOLOGY
• Founded in 2013 in Winston-Salem, NC
• Technology developed by leading
materials science and clinical researchers
at Wake Forest University. Fortis holds
exclusive licenses to key patent estate
• Product development company utilizing
advanced light-absorbing nanoparticles
to thermally ablate solid tumors
• More than 5 years of preclinical work
completed, including in vitro and in vivo
proof-of-concept demonstration

Frank M. Torti, M.D., M.P.H Executive Vice President for
Health Affairs for the University of Connecticut Health
Center and the eighth Dean of the UConn School of
Medicine.
Torti joined the Health Center from Wake Forest University
School of Medicine where he served as Vice President for
Strategic Programs, Director of the Comprehensive
Cancer Center, and Chair of the Department of Cancer
Biology. In addition, he previously served as the former
Principal Deputy Commissioner, Chief Scientist, and then
Acting Commissioner of the U.S. Food and Drug
Administration.

10/31/2013

5
“CANCER NANOTECHNOLOGY:
SMALL, BUT HEADING
FOR THE BIG TIME”

NATURE REVIEWS DRUG DISCOVERY

NATURE REVIEWS DRUG DISCOVERY 6, 174-175 (MARCH 2007) | DOI:10.1038/NRD2285

10/31/2013

6
TECHNOLOGY

Confidential

10/31/2013

7
HOW IT WORKS

10/31/2013

8
TECHNOLOGY DEVELOPMENT
MILESTONES

10/31/2013

9
HOW IS FORTIS ONCOLOGY
DIFFERENT?
•

Many options to achieve maximal thermal ablation and tumor
cell death:
•

MWCNT with or without metals;

•

a variety of geometries (MWCNT cylinders [straight,
bent, folded] or nanospheres;

•

doped with contrast agents;

•

functionalized with API and/or antibodies (for targeted
delivery to cancer cells)

•

functionalized for embolization of tumor.

•

Passive or active targeting

•

Novel nanomaterials which are soluble

•

Significant preclinical studies in large animals in vivo studies
demonstrate primary tumor and cancer stem cell ablation

•

Cytotoxic
Agent

Non-invasive, more efficacious; utilizes NIR or RF—no probes,
more thorough tumor margin ablation

•

Targeted
Delivery

No use of gold nanoparticles thus relieving regulatory burden
other groups who use these face

•

Contrast
Agent

Products for cancer therapy will follow medical device
approval path, not as a drug—reduced time to approval and
lower regulatory risk

Confidential

10/31/2013

10
THE BUSINESS

Confidential

10/31/2013

11
THE FORTIS ONCOLOGY
TEAM
Paul Rohricht, MS, MBA
Chief Executive Officer

•

Serial entrepreneur, cofounder of Revivicor, Inc.
(acquired by United
Therapeutics); co-founder of
Symphogen, Inc.

•

$500M+ in transactions.

•

Formerly CEO, Vedere LLC;
CEO, Keractive Beauty LLC;
COO Keraplast Technologies,
Inc.; Vice President
Corporate Development ICx
Technologies Inc.;
Symphogen A/S, Revivicor
Inc., and PPL Therapeutics.

•

1 issued US Patent, 4
pending

•

Wharton MBA

Confidential

John Stewart, MD
Chief Medical Officer

•

Associate Dean, Dean's
Office Associate Professor,
Surgery, Translational
Science Institute, Wake
Forest Baptist Medical.

•

Lead or co-author on key
academic papers which
underpin the Fortis
Oncology technology.

•

Assistant Professor, Plastic &
Reconstructive Surgery,
Wake Forest Medical School.

•

Expert in
cancer/oncogenesis,
drugs/therapeutic agents/
pharmaceuticals,
engineering/bioengineering,
device development,
preclinical development.

•

Lead or co-author on key
academic papers which
underpin the Fortis
Oncology technology.

•

Lead and/or Co-inventor on
key applications of Fortis
Oncology IP.

Expert in HIPEC Therapy,
surgery, oncology treatment.

•

Nicole Levi-Polyachenko, PhD
Chief Scientific Officer

•

Co-inventor on key
applications of Fortis
Oncology IP.

10/31/2013

12
BUSINESS MODEL
• Develop a suite of medical devices specific to a particular
disease area;

• License those devices to key players;
• Diagnostic imaging contrast agents
• Prospective licensees include: Potential Licensees: GE Healthcare, Philips
Healthcare, Siemens Healthcare, Toshiba Medical Systems Corporation,
Hologic, Inc., Hitachi Medical Corporation

• Cancer therapeutic medical devices
• Prospective licensees (in addition to Big Pharma/Biotech) include:
• Image-guided RFA: AngioDynamics, Boston Scientific and Covidien;
• Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical;
• Microwave Ablation: Evident Microwave Ablation (Covidien);
• High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with
General Electric (GE-) based MRI systems and therefore GE is a potential
licensee
10/31/2013

13
MARKET OPPORTUNITY

10/31/2013

14
MARKET OPPORTUNITY
MRI Diagnostic Contrast Agent Market Size
($'000M); 5% CAGR
http://www.bccresearch.com
$2,500,000
$2,000,000

Cancer Diagnostic
Imaging

$1,500,000
$1,000,000
$500,000
$2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

HIPEC
Skin Cancer
Breast Cancer
Kidney Cancer
Prostate Cancer
Soft Tissue Neoplasms
Bone Neoplasms
Breast Cancer
Brain Cancer

Market Size, Worldwide Cancer Therapy Market Size
($'000M), 18.5% CAGR
$350,000,000

$300,000,000
$250,000,000
$200,000,000
$150,000,000
$100,000,000
$50,000,000
$2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

http://www.cancer.org

10/31/2013

15
COMPETITION
• Thermal Abalation
•

Image-guided RFA: AngioDynamics, Boston Scientific and Covidien;

•

Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical;

•

Microwave Ablation: Evident Microwave Ablation (Covidien);

•

High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with General Electric
(GE-) based MRI systems and therefore GE is a potential licensee;

•

Laser Interstitial Thermal Ablation

•

Irreversible electroporation (IRE)

• Nanomaterials
•

BSD

•

Magforce AG

•

Nanospectra

• Pharma/Biotech
•

All the major players: Roche/Genentech, Pfizer, Merck, BMS, Lilly, GSK, Sanofi, Takeda.
•

Confidential

Top Cancer Drug Sales 2011: Rituxan - $3 billion; Avastin - $2.66 billion, Herceptin - $1.66
billion, Gleevec - $1.51 billion, Eloxatin - $1.2 billion, Alimta - $1.04 billion, Erbitux - $703.3
million, Velcade - $692.7 million, Xeloda - $647.6 million, Tarceva - $564.2 million
http://www.fiercepharma.com

10/31/2013

16
PRODUCT DEVELOPMENT PLAN
 Diagnostic Imaging
•

Device production for MRI cancer imaging

•

Clinical Trials

•

Regulatory Consulting (outsourced)

 Tumor Thermal Ablation
• HIPEC device production
• Clinical Trials
• Regulatory Consulting (outsourced)
 Product Development, Tumor Thermal Ablation
• Device production for interperitoneal solid
tissue cancer ablation
(gastrointestinal, kidney, pancreas
• Clinical Trials
• Regulatory Consulting (outsourced)

10/31/2013

17
REGULATORY STRATEGY
A regulatory framework is already in
place

Clinical trials are underway throughout
the world for a variety of indications
using nanomaterials in cancer

10/31/2013

18
Use of Proceeds
• Diagnostic Imaging
•
•

CAPITAL
RAISE
$5M

Device production for MRI cancer imaging
Clinical Trials

•

Regulatory Consulting (outsourced)

• Tumor Thermal Ablation
•

HIPEC device production

•

Clinical Trials

•

Regulatory Consulting (outsourced)

• Product Development, Tumor Thermal Ablation
•

Device production for interperitoneal solid tissue
cancer ablation (gastrointestinal, kidney, pancreas)

•

Clinical Trials

•

Regulatory Consulting (outsourced)

• Ongoing IP prosecution and license obligations
• Staff, General and Administrative (1 FTE, 2 part time
FTE)
10/31/2013

20
BUSINESS SUMMARY
Products

Technology

• Products to diagnose and treat:

• MWCNT with various geometries
(tube, bent, curved, folded)

•

Skin, kidney, prostate, soft tissue
neoplasms, bone neoplasms

• Advanced MRI contrast agents

• MWCNT + iron and/or other metals

• Thermal ablation of cancer devices

• Functionalized MWCNT + branched
structures for delivery of APIs

• Thermal ablation of cancer with
delivery of drugs

• Microparticle compositions

Team

IP

•

Paul Rohricht, MS MBA, CEO
•

•

John Stewart, MD, CMO
•

•

Serial entrepreneur, co-founder of Revivicor, Inc.
(acquired by United Therapeutics); co-founder of
Symphogen, Inc.; $500M+ in transactions.

Associate Professor, Surgery, Comprehensive
Cancer Center, Wake Forest Baptist Health

Nicole Levi-Polyachenko, PhD, CSO
•

Assistant Professor, Plastic & Reconstructive
Surgery, Wake Forest Medical School

• MWCNT + nitrogen and/or boron
• US 8,252,772 “Hyperthermic
Technologies and Uses Thereof”
• US 8,501,233 “Compositions and
Methods for Treating Cancer”
• Several other patents pending
including “Novel Embolizing Therapy
for the Ablation of Solid Tumors”
10/31/2013

21
CONTACT
Paul Rohricht MS MBA; CEO Fortis Oncology
+1 704.249.8342
paulrohricht@fortisoncology.com
www.fortisoncology.com
10/31/2013

22

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Fortis Oncology - Nanomedicine Solutions

  • 2. FORTIS ONCOLOGY: NANOTHERMAL MEDICAL DEVICE PRODUCTS TO ERADICATE CANCER
  • 3. CANCER TODAY THE COST OF CANCER IS HIGH. EACH OF US HAS BEEN TOUCHED WITH CANCER IN OUR LIVES; A MOTHER, FATHER, SIBLING, FRIEND. IT IS A LARGE AND GROWING MARKET AND HUGE HEALTHCARE ECONOMIC BURDEN Worldwide, there are more than 12.5M new cancer diagnoses each year, and that figure continues to climb. The total cost of cancer have been estimated to be as high as $895 billion (US) worldwide. http://www.cancer.org/ 10/31/2013 3
  • 4. OUR MISSION To bring advanced, nanothermal products to market approval that not only destroy cancer, but spare healthy tissue, without the side effects seen in conventional therapies and in doing so, build a sustainable, profitable business. Confidential 10/31/2013 4
  • 5. HISTORY OF NANOFORTIS ONCOLOGY • Founded in 2013 in Winston-Salem, NC • Technology developed by leading materials science and clinical researchers at Wake Forest University. Fortis holds exclusive licenses to key patent estate • Product development company utilizing advanced light-absorbing nanoparticles to thermally ablate solid tumors • More than 5 years of preclinical work completed, including in vitro and in vivo proof-of-concept demonstration Frank M. Torti, M.D., M.P.H Executive Vice President for Health Affairs for the University of Connecticut Health Center and the eighth Dean of the UConn School of Medicine. Torti joined the Health Center from Wake Forest University School of Medicine where he served as Vice President for Strategic Programs, Director of the Comprehensive Cancer Center, and Chair of the Department of Cancer Biology. In addition, he previously served as the former Principal Deputy Commissioner, Chief Scientist, and then Acting Commissioner of the U.S. Food and Drug Administration. 10/31/2013 5
  • 6. “CANCER NANOTECHNOLOGY: SMALL, BUT HEADING FOR THE BIG TIME” NATURE REVIEWS DRUG DISCOVERY NATURE REVIEWS DRUG DISCOVERY 6, 174-175 (MARCH 2007) | DOI:10.1038/NRD2285 10/31/2013 6
  • 10. HOW IS FORTIS ONCOLOGY DIFFERENT? • Many options to achieve maximal thermal ablation and tumor cell death: • MWCNT with or without metals; • a variety of geometries (MWCNT cylinders [straight, bent, folded] or nanospheres; • doped with contrast agents; • functionalized with API and/or antibodies (for targeted delivery to cancer cells) • functionalized for embolization of tumor. • Passive or active targeting • Novel nanomaterials which are soluble • Significant preclinical studies in large animals in vivo studies demonstrate primary tumor and cancer stem cell ablation • Cytotoxic Agent Non-invasive, more efficacious; utilizes NIR or RF—no probes, more thorough tumor margin ablation • Targeted Delivery No use of gold nanoparticles thus relieving regulatory burden other groups who use these face • Contrast Agent Products for cancer therapy will follow medical device approval path, not as a drug—reduced time to approval and lower regulatory risk Confidential 10/31/2013 10
  • 12. THE FORTIS ONCOLOGY TEAM Paul Rohricht, MS, MBA Chief Executive Officer • Serial entrepreneur, cofounder of Revivicor, Inc. (acquired by United Therapeutics); co-founder of Symphogen, Inc. • $500M+ in transactions. • Formerly CEO, Vedere LLC; CEO, Keractive Beauty LLC; COO Keraplast Technologies, Inc.; Vice President Corporate Development ICx Technologies Inc.; Symphogen A/S, Revivicor Inc., and PPL Therapeutics. • 1 issued US Patent, 4 pending • Wharton MBA Confidential John Stewart, MD Chief Medical Officer • Associate Dean, Dean's Office Associate Professor, Surgery, Translational Science Institute, Wake Forest Baptist Medical. • Lead or co-author on key academic papers which underpin the Fortis Oncology technology. • Assistant Professor, Plastic & Reconstructive Surgery, Wake Forest Medical School. • Expert in cancer/oncogenesis, drugs/therapeutic agents/ pharmaceuticals, engineering/bioengineering, device development, preclinical development. • Lead or co-author on key academic papers which underpin the Fortis Oncology technology. • Lead and/or Co-inventor on key applications of Fortis Oncology IP. Expert in HIPEC Therapy, surgery, oncology treatment. • Nicole Levi-Polyachenko, PhD Chief Scientific Officer • Co-inventor on key applications of Fortis Oncology IP. 10/31/2013 12
  • 13. BUSINESS MODEL • Develop a suite of medical devices specific to a particular disease area; • License those devices to key players; • Diagnostic imaging contrast agents • Prospective licensees include: Potential Licensees: GE Healthcare, Philips Healthcare, Siemens Healthcare, Toshiba Medical Systems Corporation, Hologic, Inc., Hitachi Medical Corporation • Cancer therapeutic medical devices • Prospective licensees (in addition to Big Pharma/Biotech) include: • Image-guided RFA: AngioDynamics, Boston Scientific and Covidien; • Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical; • Microwave Ablation: Evident Microwave Ablation (Covidien); • High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with General Electric (GE-) based MRI systems and therefore GE is a potential licensee 10/31/2013 13
  • 15. MARKET OPPORTUNITY MRI Diagnostic Contrast Agent Market Size ($'000M); 5% CAGR http://www.bccresearch.com $2,500,000 $2,000,000 Cancer Diagnostic Imaging $1,500,000 $1,000,000 $500,000 $2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 HIPEC Skin Cancer Breast Cancer Kidney Cancer Prostate Cancer Soft Tissue Neoplasms Bone Neoplasms Breast Cancer Brain Cancer Market Size, Worldwide Cancer Therapy Market Size ($'000M), 18.5% CAGR $350,000,000 $300,000,000 $250,000,000 $200,000,000 $150,000,000 $100,000,000 $50,000,000 $2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 http://www.cancer.org 10/31/2013 15
  • 16. COMPETITION • Thermal Abalation • Image-guided RFA: AngioDynamics, Boston Scientific and Covidien; • Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical; • Microwave Ablation: Evident Microwave Ablation (Covidien); • High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with General Electric (GE-) based MRI systems and therefore GE is a potential licensee; • Laser Interstitial Thermal Ablation • Irreversible electroporation (IRE) • Nanomaterials • BSD • Magforce AG • Nanospectra • Pharma/Biotech • All the major players: Roche/Genentech, Pfizer, Merck, BMS, Lilly, GSK, Sanofi, Takeda. • Confidential Top Cancer Drug Sales 2011: Rituxan - $3 billion; Avastin - $2.66 billion, Herceptin - $1.66 billion, Gleevec - $1.51 billion, Eloxatin - $1.2 billion, Alimta - $1.04 billion, Erbitux - $703.3 million, Velcade - $692.7 million, Xeloda - $647.6 million, Tarceva - $564.2 million http://www.fiercepharma.com 10/31/2013 16
  • 17. PRODUCT DEVELOPMENT PLAN  Diagnostic Imaging • Device production for MRI cancer imaging • Clinical Trials • Regulatory Consulting (outsourced)  Tumor Thermal Ablation • HIPEC device production • Clinical Trials • Regulatory Consulting (outsourced)  Product Development, Tumor Thermal Ablation • Device production for interperitoneal solid tissue cancer ablation (gastrointestinal, kidney, pancreas • Clinical Trials • Regulatory Consulting (outsourced) 10/31/2013 17
  • 18. REGULATORY STRATEGY A regulatory framework is already in place Clinical trials are underway throughout the world for a variety of indications using nanomaterials in cancer 10/31/2013 18
  • 19. Use of Proceeds • Diagnostic Imaging • • CAPITAL RAISE $5M Device production for MRI cancer imaging Clinical Trials • Regulatory Consulting (outsourced) • Tumor Thermal Ablation • HIPEC device production • Clinical Trials • Regulatory Consulting (outsourced) • Product Development, Tumor Thermal Ablation • Device production for interperitoneal solid tissue cancer ablation (gastrointestinal, kidney, pancreas) • Clinical Trials • Regulatory Consulting (outsourced) • Ongoing IP prosecution and license obligations • Staff, General and Administrative (1 FTE, 2 part time FTE) 10/31/2013 20
  • 20. BUSINESS SUMMARY Products Technology • Products to diagnose and treat: • MWCNT with various geometries (tube, bent, curved, folded) • Skin, kidney, prostate, soft tissue neoplasms, bone neoplasms • Advanced MRI contrast agents • MWCNT + iron and/or other metals • Thermal ablation of cancer devices • Functionalized MWCNT + branched structures for delivery of APIs • Thermal ablation of cancer with delivery of drugs • Microparticle compositions Team IP • Paul Rohricht, MS MBA, CEO • • John Stewart, MD, CMO • • Serial entrepreneur, co-founder of Revivicor, Inc. (acquired by United Therapeutics); co-founder of Symphogen, Inc.; $500M+ in transactions. Associate Professor, Surgery, Comprehensive Cancer Center, Wake Forest Baptist Health Nicole Levi-Polyachenko, PhD, CSO • Assistant Professor, Plastic & Reconstructive Surgery, Wake Forest Medical School • MWCNT + nitrogen and/or boron • US 8,252,772 “Hyperthermic Technologies and Uses Thereof” • US 8,501,233 “Compositions and Methods for Treating Cancer” • Several other patents pending including “Novel Embolizing Therapy for the Ablation of Solid Tumors” 10/31/2013 21
  • 21. CONTACT Paul Rohricht MS MBA; CEO Fortis Oncology +1 704.249.8342 paulrohricht@fortisoncology.com www.fortisoncology.com 10/31/2013 22