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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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FORTIS ONCOLOGY: NANOTHERMAL MEDICAL DEVICE PRODUCTS TO ERADICATE CANCER
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.
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CANCER TODAY
http://www.cancer.org/
Confidential
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. 04/13/2023 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
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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.
“CANCER NANOTECHNOLOGY: SMALL, BUT HEADINGFOR THE BIG TIME”
NATURE REVIEWS DRUG DISCOVERY
NATURE REVIEWS DRUG DISCOVERY 6, 174-175 (MARCH 2007) | DOI:10.1038/NRD2285
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Confidential
TECHNOLOGY
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HOW IT WORKS
04/13/2023 8
TECHNOLOGY DEVELOPMENTMILESTONES
04/13/2023 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
• 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
04/13/2023Confidential 10
ContrastAgent
TargetedDelivery
CytotoxicAgent
Confidential
THE BUSINESS
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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.
04/13/2023 12Confidential
John Stewart, MD Chief Medical Officer
Nicole Levi-Polyachenko, PhD Chief Scientific Officer
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
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MARKET OPPORTUNITY
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MARKET OPPORTUNITY
Cancer Diagnostic Imaging
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2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 $-
$500,000
$1,000,000
$1,500,000
$2,000,000
$2,500,000
MRI Diagnostic Contrast Agent Market Size ($'000M); 5% CAGR
http://www.bccresearch.com
http://www.cancer.org
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 $-
$50,000,000
$100,000,000
$150,000,000
$200,000,000
$250,000,000
$300,000,000
$350,000,000
Market Size, Worldwide Cancer Therapy Market Size ($'000M), 18.5% CAGRHIPEC
Skin CancerBreast CancerKidney CancerProstate CancerSoft Tissue NeoplasmsBone NeoplasmsBreast CancerBrain Cancer
Confidential
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
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http://www.fiercepharma.com
PRODUCT DEVELOPMENT PLAN
Diagnostic Imaging
• Device production for MRI cancer imaging
• Clinical Trials
• Regulatory Consulting (outsourced)
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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)
REGULATORY STRATEGYA regulatory framework is already in place
Clinical trials are underway throughout the world for a variety of indications using nanomaterials in cancer
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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
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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 “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”
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BUSINESS SUMMARY
CONTACT
04/13/2023 22
Paul Rohricht MS MBA; CEO Fortis Oncology
+1 704.249.8342
www.fortisoncology.com