fortis oncology nanomedicine solutions

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INVESTOR PRESENTATION 10/31/2013 www.fortisoncology.com

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Targeted nanoparticle tumor ablation. Multi-walled Carbon Nanotubes (MWCNT) are designed with internal antennae tuned to a specific Near Infrared (NIR) laser frequency, which when activated, oscillate at high speeds, generating thermal energy (heat) sufficient to cause cell apoptosis. Using targeting probes, the MWCNT only seek out, attach to, and within, specific cancer cells. The NIR laser is non-invasive, and does not injure the skin. The MWCNT can also be conjugated with probes for very specific imaging for diagnostics purposes using existing MRI technology.

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Page 1: Fortis oncology   nanomedicine solutions

INVESTOR PRESENTATION 10/31/2013

www.fortisoncology.com

Page 2: Fortis oncology   nanomedicine solutions

FORTIS ONCOLOGY: NANOTHERMAL MEDICAL DEVICE PRODUCTS TO ERADICATE CANCER

Page 3: Fortis oncology   nanomedicine solutions

THE COST OF CANCER IS HIGH.EACH OF US HAS BEEN TOUCHEDWITH CANCER IN OUR LIVES; AMOTHER, FATHER, SIBLING, FRIEND.IT IS A LARGE AND GROWINGMARKET AND HUGE HEALTHCAREECONOMIC BURDEN

Worldwide, there are more than12.5M new cancer diagnoses eachyear, and that figure continues toclimb.

The total cost of cancer have beenestimated to be as high as $895billion (US) worldwide.

10/31/2013 3

CANCER TODAY

http://www.cancer.org/

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OUR MISSIONTo 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.

10/31/2013Confidential 4

Page 5: Fortis oncology   nanomedicine solutions

HISTORY OF NANOFORTISONCOLOGY• 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 vivoproof-of-concept demonstration

10/31/2013 5

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.

Page 6: Fortis oncology   nanomedicine solutions

“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

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TECHNOLOGY

10/31/2013Confidential 7

Page 8: Fortis oncology   nanomedicine solutions

HOW IT WORKS

10/31/2013 8

Page 9: Fortis oncology   nanomedicine solutions

TECHNOLOGY DEVELOPMENTMILESTONES

10/31/2013 9

Page 10: Fortis oncology   nanomedicine solutions

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

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

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

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

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

10/31/2013Confidential 10

ContrastAgent

TargetedDelivery

CytotoxicAgent

Page 11: Fortis oncology   nanomedicine solutions

THE BUSINESS

10/31/2013Confidential 11

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THE FORTIS ONCOLOGY TEAMPaul Rohricht, MS, MBA Chief Executive Officer

• Serial entrepreneur, co-founder 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

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

• Expert in HIPEC Therapy, surgery, oncology treatment.

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

• Co-inventor on key applications of Fortis Oncology IP.

• 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.

10/31/2013 12Confidential

John Stewart, MD Chief Medical Officer

Nicole Levi-Polyachenko, PhD Chief Scientific Officer

Page 13: Fortis oncology   nanomedicine solutions

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

Page 14: Fortis oncology   nanomedicine solutions

MARKET OPPORTUNITY

10/31/2013 14

Page 15: Fortis oncology   nanomedicine solutions

MARKET OPPORTUNITY

Cancer Diagnostic Imaging

10/31/2013 15

$-

$500,000

$1,000,000

$1,500,000

$2,000,000

$2,500,000

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

MRI Diagnostic Contrast Agent Market Size ($'000M); 5% CAGR http://www.bccresearch.com

http://www.cancer.org

$-

$50,000,000

$100,000,000

$150,000,000

$200,000,000

$250,000,000

$300,000,000

$350,000,000

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

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

Skin CancerBreast CancerKidney CancerProstate CancerSoft Tissue NeoplasmsBone NeoplasmsBreast CancerBrain Cancer

Page 16: Fortis oncology   nanomedicine solutions

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.

• 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

10/31/2013Confidential 16

http://www.fiercepharma.com

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PRODUCT DEVELOPMENT PLAN

Diagnostic Imaging

• Device production for MRI cancer imaging

• Clinical Trials

• Regulatory Consulting (outsourced)

10/31/2013 17

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)

Page 18: Fortis oncology   nanomedicine solutions

REGULATORY STRATEGYA 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

Page 19: Fortis oncology   nanomedicine solutions

CAPITAL RAISE

Use of Proceeds

• 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)

• Ongoing IP prosecution and license obligations

• Staff, General and Administrative (1 FTE, 2 part time FTE)

$5M

10/31/2013 20

Page 20: Fortis oncology   nanomedicine solutions

Products

• Products to diagnose and treat:

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

• Advanced MRI contrast agents

• Thermal ablation of cancer devices

• Thermal ablation of cancer with delivery of drugs

Team

• Paul Rohricht, MS MBA, CEO• Serial entrepreneur, co-founder of Revivicor, Inc.

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

• John Stewart, MD, CMO• Associate Professor, Surgery, Comprehensive

Cancer Center, Wake Forest Baptist Health

• Nicole Levi-Polyachenko, PhD, CSO• Assistant Professor, Plastic & Reconstructive

Surgery, Wake Forest Medical School

Technology

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

• MWCNT + iron and/or other metals

• Functionalized MWCNT + branched structures for delivery of APIs

• Microparticle compositions

• MWCNT + nitrogen and/or boron

IP

• US 8,252,772 “HyperthermicTechnologies 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

BUSINESS SUMMARY

Page 21: Fortis oncology   nanomedicine solutions

CONTACT

10/31/2013 22

Paul Rohricht MS MBA; CEO Fortis Oncology

+1 704.249.8342

[email protected]

www.fortisoncology.com