siva therapeutics inc - angel capital summit...

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:

Invasive,

Risky,

Disfiguring,

Moderately effective at best, and

Extremely costly.

Siva’s approach addresses all of these issues.

2


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


Market Need and Business Model

Skin cancer will be our entry market.

4 NCI

We will sell a non-

surgical skin cancer

therapy, through

channel partners to

oncology clinics, that

uses SivaRods™ to

target and heat

tumors.


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

5


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

6


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

7

-$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


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.

8

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


In Vivo Photothermal Tumor Therapy 2 of 2


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

11 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)


Competition and Risks

12

Efficacy / Safety

Cost / In

vasiv

en

ess

HIGH LOW

HIG

H

LO

W

Chemotherapy

Directed Energy

Surgery

Radiation

Colloidal Gold SivaRod™

Therapy

Nanoshells /

Nanospheres


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


Funding Sought and Exit Strategy

14

$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


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


Thank You ACS and RVC Members

‘Precision Tumor Targeting’

Len Pagliaro, PhD, CEO

[email protected]

www.sivatherapeutics.com

+1 425 443 4344

16

mailto:[email protected]

http://www.sivatherapeutics.com/


SIVA – The Name

17

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

representing destruction and recreation – the natural

process enabled by SivaRods™. Backup Slide

http://dustysojourner.files.wordpress.com/2009/06/shiva_nataraja_musee_guimet_25971.jpg


The Technology

18

Hyperthermic treatment of

cancer – known for many

years, difficult to target

tumors.

Enhanced permeability and

retention (EPR) – ‘leakiness’

of tumor vasculature.

SivaRods™ localize to

tumors and are heated with

infrared light.

- gold

- 12 x 50 nm

- absorb at

810 nm


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

19 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)


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


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)


Melanoma Staging

22

NCI website NCI

Backup Slide

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