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Siva Therapeutics Inc
‘Precision Tumor Targeting’
Len Pagliaro, PhD, CEO
Angel Capital Summit Presentation
March 22, 2012
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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.
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.
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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%)
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
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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.
8
After injection,
SivaRods™ are
heated with infrared
light to destroy the
tumor tissue.
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Siva Therapeutics Inc 9
In Vivo Photothermal Tumor Therapy 1 of 2
InfraRed (IR) irradiation 72
hrs following injection of:
Nanorods
Saline
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Siva Therapeutics Inc 10
In Vivo Photothermal Tumor Therapy 2 of 2
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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
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)
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Siva Therapeutics Inc
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
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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
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
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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
www.sivatherapeutics.com
+1 425 443 4344
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Siva Therapeutics Inc
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
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Siva Therapeutics Inc
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
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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
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)
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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)
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Siva Therapeutics Inc
Melanoma Staging
22
NCI website NCI
Backup Slide