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.
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
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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