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

Siva Therapeutics Inc

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.

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Siva Therapeutics Inc

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.

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Siva Therapeutics Inc

Market Need and Business Model

 Skin cancer will be our entry market.

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NCI

 We will sell a non-

surgical skin cancer therapy, through channel partners to

• ncology clinics, that

uses SivaRods™ to target and heat tumors.

Siva Therapeutics Inc

 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 New Cases

70,000 3,500,000 3,570,000

Stage II +

8,400 70,000 78,400

Siva Target

4,200 7,000

11,200

Initial Target Market: Skin Cancer

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Siva Therapeutics Inc

Price Per Treatment Number of Patient Treatments per Year

8,000 10,000 12,000 14,000 $20,000 $160M $200M $240M $280M $25,000 $200M $250M $300M $350M $30,000 $240M

$300M $360M

$420M $35,000 $280M $350M $420M $490M $40,000 $320M $400M $480M $560M

 Projected market 2 years post launch: $340M.

Initial (Skin Cancer) Market Projection

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Siva Therapeutics Inc

Financial Projections

Stage 2B and beyond melanomas (50%) and carcinomas (10%)

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• $10,000

$0 $10,000 $20,000 $30,000 $40,000 $50,000 $60,000 $70,000 $80,000 2012 2013 2014 2015 2016 2017 2018 2019 2020

(dollars in thousands)

Siva Revenue COGS EBITDA

Siva Therapeutics Inc

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.

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 After injection,

SivaRods™ are heated with infrared light to destroy the tumor tissue.

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 10

In Vivo Photothermal Tumor Therapy

2 of 2

Siva Therapeutics Inc

Feb-2012 Jul-2013 Nov-2014 Mar-2016 Aug-2017 First Funding Round Preclinical Studies First FDA pre-IDE Meeting Draft Clinical Study Plan Second FDA pre-IDE Meeting Pilot Clinical Study Pivotal Clinical Study PMA Submission and Approval Launch of FDA Approved Product

Milestones for Development

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Costs in MUSD

IDE

EXIT

Product Launch ANGEL FINANCING

$2.2M

Full pre-clinical package and entry to clinic TOTAL to EXIT

$5.5M

Acquisition / Strategic Partnership TOTAL to MARKET

$23.8M (72% R&D)

Siva Therapeutics Inc

Competition and Risks

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Efficacy / Safety Cost / Invasiveness

HIGH LOW HIGH LOW

Chemotherapy Directed Energy Surgery Radiation Colloidal Gold SivaRod™ Therapy Nanoshells / Nanospheres

Siva Therapeutics Inc

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.

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Siva Therapeutics Inc

Funding Sought and Exit Strategy

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 $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

Siva Therapeutics Inc

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

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Siva Therapeutics Inc

Thank You ACS and RVC Members

‘Precision Tumor Targeting’

Len Pagliaro, PhD, CEO len.pagliaro@sivatherapeutics.com www.sivatherapeutics.com +1 425 443 4344

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Siva Therapeutics Inc

SIVA – The Name

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SIVA (also Siva Nataraja or Shiva) is the Hindu deity

representing destruction and recreation – the natural process enabled by SivaRods™.

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Siva Therapeutics Inc

The Technology

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 Hyperthermic treatment of

cancer – known for many years, difficult to target tumors.

 Enhanced permeability and

retention (EPR) – ‘leakiness’

• f tumor vasculature.

 SivaRods™ localize to

tumors and are heated with infrared light.

• gold
• 12 x 50 nm
• absorb at

810 nm

Siva Therapeutics Inc

Feb-2012 Jul-2013 Nov-2014 Mar-2016 Aug-2017 First Funding Round Preclinical Studies First FDA pre-IDE Meeting Draft Clinical Study Plan Second FDA pre-IDE Meeting Pilot Clinical Study Pivotal Clinical Study PMA Submission and Approval Launch of FDA Approved Product

Milestones for Development

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Costs in MUSD

IDE

EXIT

Product Launch

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

TOTAL to EXIT $5.5M

Acquisition or Strategic Partnership

TOTAL to MARKET $23.8M (72% R&D)

Siva Therapeutics Inc

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.

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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)

Siva Therapeutics Inc

Melanoma Staging

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NCI website NCI

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