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Siva Therapeutics Inc Precision Tumor Targeting Len Pagliaro, PhD, - PowerPoint PPT Presentation

Siva Therapeutics Inc Precision Tumor Targeting Len Pagliaro, PhD, CEO Angel Capital Summit Presentation March 22, 2012 Why Siva? There are many limitations of current cancer therapies. Cancer patients face therapies that are:


  1. Siva Therapeutics Inc ‘Precision Tumor Targeting’ Len Pagliaro, PhD, CEO Angel Capital Summit Presentation March 22, 2012

  2. Why Siva?  There are many limitations of current cancer therapies. Cancer patients face therapies that are:  Invasive,  Risky,  Disfiguring,  Moderately effective at best, and  Extremely costly.  Siva’s approach addresses all of these issues. 2 Siva Therapeutics Inc

  3. Business Opportunity  Siva is developing a cancer treatment that will be:  Safer and less invasive than current therapies;  Effective and competitively priced ;  Not dreaded by patients;  And will be a compelling option for reimbursement. 3 Siva Therapeutics Inc

  4. Market Need and Business Model  Skin cancer will be our entry market.  We will sell a non- surgical skin cancer therapy, through channel partners to oncology clinics, that uses SivaRods™ to target and heat tumors. NCI 4 Siva Therapeutics Inc

  5. Initial Target Market: Skin Cancer  Goal: To capture 50% of Stage II and beyond melanoma, and 10% of Stage II and beyond non- melanoma patients 2 years after launch of the FDA-approved product. (does not include RoW) Melanoma Non-Melanoma Total 70,000 3,500,000 3,570,000 New Cases 8,400 70,000 78,400 Stage II + 11,200 4,200 7,000 Siva Target 5 Siva Therapeutics Inc

  6. Initial (Skin Cancer) Market Projection  Projected market 2 years post launch: $340M . Number of Patient Treatments per Year Price Per Treatment 8,000 10,000 12,000 14,000 $20,000 $160M $200M $240M $280M $25,000 $200M $250M $300M $350M $300M $360M $30,000 $240M $420M $35,000 $280M $350M $420M $490M $40,000 $320M $400M $480M $560M 6 Siva Therapeutics Inc

  7. Financial Projections Stage 2B and beyond melanomas (50%) and carcinomas (10%) (dollars in thousands) $80,000 $70,000 Siva Revenue $60,000 COGS $50,000 EBITDA $40,000 $30,000 $20,000 $10,000 $0 2012 2013 2014 2015 2016 2017 2018 2019 2020 -$10,000 7 Siva Therapeutics Inc

  8. The Product: SivaRods ™  A suspension of precision gold nanorods in sterile saline for injection.  Very safe – excreted in urine.  SivaRods ™ concentrate in solid tumors following injection.  After injection, SivaRods ™ are heated with infrared light to destroy the tumor tissue. 8 Siva Therapeutics Inc

  9. In Vivo Photothermal Tumor Therapy 1 of 2 InfraRed (IR) irradiation 72 hrs following injection of: Nanorods Saline Siva Therapeutics Inc 9

  10. In Vivo Photothermal Tumor Therapy 2 of 2 Siva Therapeutics Inc 10

  11. Milestones for Development Feb-2012 Jul-2013 Nov-2014 Mar-2016 Aug-2017 First Funding Round Preclinical Studies First FDA pre-IDE Meeting Draft Clinical Study Plan EXIT IDE Second FDA pre-IDE Meeting Pilot Clinical Study Pivotal Clinical Study PMA Submission and Approval Product Launch Launch of FDA Approved Product $2.2M ANGEL FINANCING Full pre-clinical package and entry to clinic Acquisition / Strategic $5.5M TOTAL to EXIT Partnership $23.8M (72% R&D) TOTAL to MARKET Costs in MUSD 11 Siva Therapeutics Inc

  12. Competition and Risks LOW Cost / Invasiveness SivaRod ™ Colloidal Gold Therapy Nanoshells / Nanospheres Directed Energy Radiation Surgery HIGH Chemotherapy LOW HIGH Efficacy / Safety 12 Siva Therapeutics Inc

  13. Competitive Advantages  Safe, Effective, and Minimally Invasive  Simple – Device , not Drug  Strong collaboration with Anschutz Medical Center  Strong and growing IP portfolio for:  Scale-up of manufacture of gold nanorods (exclusive),  Large-scale purification of gold nanorods (exclusive),  Surface modifications of gold nanorods (exclusive), &  Use of nanorods for human cancer therapy. 13 Siva Therapeutics Inc

  14. Funding Sought and Exit Strategy  $2.2 million will enable us to:  Complete full pre-clinical data set.  File and obtain Investigative Device Exemption (IDE), and  Develop protocols for first clinical studies.  Total to Exit: ~$5.5 million.  Exit via acquisition or strategic partnership during Phase 1 clinical trials.  Pharmaceutical, device, or healthcare company.  Partnership, milestone, and royalty payments 14 Siva Therapeutics Inc

  15. Management and Advisory Team  Len Pagliaro, PhD – CEO  Colin Shepherd, PhD, MBA - CFO  Bill Young – VP Business Development  Steve Kregstein, JD – Chief Legal Officer  Candidate Identified, PhD – VP of R&D Advisors  Jack Wheeler, MicroPhage (FDA clearance Q4 2011)  Sangeeta Bhatia, MD, PhD, MIT  Antonio Jimeno, MD, PhD, Anschutz Medical Center  Arlen Meyers, MD, MBA, Anschutz Medical Center 15 Siva Therapeutics Inc

  16. Thank You ACS and RVC Members ‘Precision Tumor Targeting’ Len Pagliaro, PhD, CEO len.pagliaro@sivatherapeutics.com www.sivatherapeutics.com +1 425 443 4344 16 Siva Therapeutics Inc

  17. SIVA – The Name SIVA (also Siva Nataraja or Shiva) is the Hindu deity representing destruction and recreation – the natural process enabled by SivaRods ™. Backup Slide 17 Siva Therapeutics Inc

  18. The Technology  Hyperthermic treatment of - gold cancer – known for many - 12 x 50 nm years, difficult to target - absorb at 810 nm tumors.  Enhanced permeability and retention (EPR) – ‘leakiness’ of tumor vasculature.  SivaRods ™ localize to tumors and are heated with infrared light. 18 Siva Therapeutics Inc

  19. Milestones for Development Feb-2012 Jul-2013 Nov-2014 Mar-2016 Aug-2017 First Funding Round Preclinical Studies First FDA pre-IDE Meeting Draft Clinical Study Plan EXIT IDE Second FDA pre-IDE Meeting Pilot Clinical Study Pivotal Clinical Study PMA Submission and Approval Product Launch Launch of FDA Approved Product R&D Costs $1.6 $2.5 $9.5 $3.5 G & A Costs $0.6 $0.8 $2.6 $2.7 Subtotals $2.2 $3.3 $12.1 $6.2 Acquisition or Strategic Partnership TOTAL to EXIT $5.5M TOTAL to MARKET $23.8M (72% R&D) Costs in MUSD 19 Siva Therapeutics Inc

  20. Competition and Risks  Chemotherapy, radiation, surgery.  Yervoy (ipilimumab), BMS, approved March 2011, metastatic melanoma. Treatment costs $120,000; median survival increased from 6.4 months to 10 months.  Zelboraf (PLX4032), Roche-Genentech, approved August 2011. Treatment costs $56,000 and targets ~45% of patient population (BRAF V600E positive).  Colloidal gold – No known risks; doesn’t heat adequately.  Directed energy - Radio frequency, ultrasound, and microwave lack selectivity.  Nanoshells, nanospheres - Large (140 nm) particles, clearance issues in clinical trials. 20 Siva Therapeutics Inc

  21. Does it Work?  Experimentally induced tumors in mice.  Mice injected with gold nanorods and control animals (saline-injected).  Areas exposed to infra-red laser irradiation, and control areas (non- irradiated).  Work published in: von Maltzahn et al. (2009) Computationally Guided Photothermal Tumor Therapy Using Long-Circulating Gold Nanorod Antennas. Cancer Research , 69:3892-3900. (Laboratory of Sangeeta Bhatia, MD, PhD) 21 Siva Therapeutics Inc

  22. Melanoma Staging NCI NCI website Backup Slide 22 Siva Therapeutics Inc

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