Fortis oncology nanomedicine solutions

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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 nanomedicine solutions

  1. 1. www.fortisoncology.com INVESTOR PRESENTATION 10/31/2013
  2. 2. FORTIS ONCOLOGY: NANOTHERMAL MEDICAL DEVICE PRODUCTS TO ERADICATE CANCER
  3. 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. 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. 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. 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
  7. 7. TECHNOLOGY Confidential 10/31/2013 7
  8. 8. HOW IT WORKS 10/31/2013 8
  9. 9. TECHNOLOGY DEVELOPMENT MILESTONES 10/31/2013 9
  10. 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
  11. 11. THE BUSINESS Confidential 10/31/2013 11
  12. 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. 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
  14. 14. MARKET OPPORTUNITY 10/31/2013 14
  15. 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. 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. 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. 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. 19. Use of Proceeds • Diagnostic Imaging • • $5M Clinical Trials • CAPITAL RAISE Device production for MRI cancer imaging 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. 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. 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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