SCIE Investor Presentation January 2017

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1 Investor Presentation OTC/QB: SCIE January, 2017

Transcript of SCIE Investor Presentation January 2017

Page 1: SCIE Investor Presentation January 2017

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Investor PresentationOTC/QB: SCIE

January, 2017

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Safe Harbor Statement

This presentation contains statements of a forward-looking nature which represent our management's beliefs and assumptions concerning future events. When used in this presentation, the words “believe,” “expect,” and similar expressions are intended to identify forward-looking statements, including statements regarding revenue, distribution agreements and potential partnerships.  Forward-looking statements involve risks, uncertainties and assumptions, and are based on information currently available to us. Actual results may differ materially from those expressed in the forward-looking statements due to many factors, including, without limitation, those disclosed under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 and our quarterly reports on Form 10-Q. We undertake no obligation to update any forward-looking statements to reflect events or circumstances that may arise after the date of this presentation.

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Investment Highlights♦ Patented platform technologies using light to provide faster, more

accurate, less costly non-invasive detection and diagnosis of cancerous tissue– Replaces physical biopsies with optical biopsies when differentiating

between normal and cancerous tissue– Only “true” optical biopsy– Procedure can be performed by nurses – In vivo, in real time, approximately 1 second

♦ First indication ready for immediate sales in Europe and Middle East♦ Second indication ready for clinical evaluation♦ Product exceeds medical society’s accuracy criteria ♦ Technology & Development Risk behind us♦ Sales, Marketing and Manufacturing Execution♦ Management team with extensive turnaround and commercial

experience

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Key ManagementTeam BackgroundMichael OliverPresident & CEO

♦30 years of experience in the medical device field spanning management, sales and marketing

♦Expertise in commercial operations and product management♦Four previous successful turnaround / restarts at Prescription Health Services,

Diatek, Inc., New Image Industries, and “A” Company Orthodontics♦MBA, George Washington University; BS, United States Naval Academy

Lowell GiffhornChief Financial Officer

♦More than 25 years of senior management experience spanning finance, operations, strategic planning and turnaround situations

♦Former CFO of Patriot Scientific & Sym-Tek Systems, Inc.♦Raised more than $30MM in public equity ♦MBA, National University; BS in Accounting, University of Illinois

Hughes WielemansDirector,European Sales

♦More than 25 years experience in medical device sales and marketing♦Experience with direct sales and distributor models♦Previous companies: US Surgical, Tyco Healthcare, Covidien♦Fluent in English, French, Dutch and German♦Economic Sciences Degree from ICHEC, Brussels, and Vierick-Leuven Ghent

Business School

♦ Board with more than 150 years of medical device experience ♦ Internationally renowned Medical Advisors

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Platform Diagnostic Technologies

♦ Laser-Induced Fluorescence Spectroscopy (LIFS)– Colon– Bladder – Brain– Pancreas– Barrett’s Esophagus (BE)

♦ Scattering Spectroscopy– Barrett’s Esophagus (BE)– Inflammatory Bowel Disease (IBD)– Cervix– Skin– Prostate

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Strong Intellectual Property Position

♦The largest patent portfolio for “optical methods for identifying cancer and its precursors” provides a substantial barrier to entry

♦38 utility and 7 design patents in US and approximately 28 active European and Canadian counterparts

– Optical biopsy apparatus (forceps)– Scanning technologies (detection)– Analysis and analytics– Calibration, alignment, normalizing, etc.

♦Continue to broaden product offerings through licensing and acquisition

– Recent IP license from Duke University

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US Patent Portfolio

DIAGNOSTIC

OPTICAL FORCEPS

US6847490

US6394964

US6174291

US6129683

US6066102

US5843000

US5762613

SCANNING ARRAY

US6826422

US6411835

US6104945

US5713364

CONFOCAL OPTICS

US6760613

US6411838

SPECTRAL ANALYSIS

APPLICATIONS

US7260248

US7136518

US7127282

US7103401

US6933154

US6427082

US8005527

OBSTRUCTION

US7309867

US7282723

US6818903

NORMALIZATION

US7310547

US6839661

US6768918

US6421553

US6385484

CALIBRATION

US7459696

IMAGING

TEMPORAL ALIGNMENT

US7406215

US7187810

US6902935

FOCUS

US7469160

a/LCI

US5555277

US7903254

US8537366

US8860945

US9335154

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85% of Cancer Originates in Epithelial Tissue

Platform Technology Adaptable to a Wide Spectrum of Cancers

Annual Procedures US ($Cost*)

Esophagus1,600,000 ($4.0B)

Colon8,900,000 ($17B)

Bladder660,000 ($1.1B)

Oral Cavity884,000 ($0.9B)

Lung220,000 ($0.38B)

Stomach294,000 ($0.6B)

Cervix1,320,000 ($1.32B)

- Areas of Interest

• US, annual endoscopy monitoring cost• and Duke (under UCSF support)

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Diagnostic Opportunities

Lower GIColon

Upper GIBarrett’s

Lower GIIBD

UrologyBladder

US & EU Cases/year1 12.2 M 3.9 M 5.4 M 1.2M

Revenue/Case2 $162.00 $550.00 $ 650.00 $1,045.00

Total Addressable Market (per annum)

$ 2.0 Billion $ 2.15 Billion $3.5 Billion $1.25 Billion

First Revenue 2017 2018 2019 2018

1Statistics from National Cancer Institute data base2Company Estimates

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Initial Target: Colorectal Cancer Screening

♦ Reduce total cost of colorectal cancer screening♦ 80% of physical biopsies removed during screening are normal tissue♦ Pathology savings alone in US for those unnecessary “normal tissue”

biopsies is more than $1 Billion per year**♦ UK Savings approximately £ 60,000,000 annually♦ WavSTAT Optical Biopsy System is a valuable tool in realizing savings

Economic Considerations

WavSTAT Reduces False Negatives

* AMC, Netherlands, 2012** Kessler WR, Imperiale TF, Klein RW, Wielage RC, Rex DK. A

quantitative assessment of the risks and cost savings of forgoing histologic examination of diminutive polyps. Endoscopy. 2011 Aug;43(8):683-91.

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Future Colorectal Cancer Screening

♦ Growth in screening as population ages♦ New modalities (DNA, MRI) for preliminary screening

bring more people to colonoscopy♦ If benign: Diagnose and Ignore♦ If malignant: Resect and Discard

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WavSTAT Meets the Need (Colon)

♦ American Society for Gastrointestinal Endoscopy (ASGE)– Preservation and Incorporation of Valuable endoscopic Innovation

(PIVI)– Real-Time Endoscopic Assessment of Histology of Diminutive

Colorectal Polyps (2011)– “…reduce costs and improve patient safety compared to current

paradigm.”– “…therapeutic threshold that must be met for a technology or device to

become considered appropriate for incorporation into clinical practice.”– 90% or greater Negative Predictive Value (NPV)– “The ASGE encourages and supports the appropriate use of

technologies that meet its established PIVI thresholds.”

♦WavSTAT NPV is 96% overall, 98% in recto-sigmoid colon*

Dr. Noor Mohammed, presentation at UEGW, October 2016Dr. Noor Mohammed, presentation to BSG, June 2016

*Dr. Timo Rath, et. al., Endoscopy, April 2016*Dr. Timo Rath, presentation at UEGW, October 2015

*Pr. Helmut Neumann, presentation at DDW, May 2015

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MORDIS Evaluation (Colon)

♦ Multi-Center, Prospective Marketing Evaluation– 8 sites, 7 nations, 800+ patient specimens– Italy, Germany, France, Sweden, Denmark, Belgium, UK– Leading authorities in each country– Early results promising

♦ Replicate results of 96-98% NPV♦ Capture economic savings at each site♦ Submit to approval authorities in each country♦ Coverage determination♦ Accepted as “Standard of Care”♦ Completed data collection Q4 2016

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WavSTAT Optical Biopsy System®

♦ Nothing new for the clinician to learn– Designed as a tool to assist– Procedure does not change

♦ Compatible with existing endoscopes– Uses working channel of flexible endoscopes

♦ Business Model (Razor/Blade)– Recurring revenue stream from disposables– Mobile console leased at nominal charge– Hospital customers familiar with this model

Output = 1 second

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WavSTAT Optical Biopsy System®

♦ Definitive, instant diagnosis

♦ Non-subjective, no interpretation

♦ Significantly reduces costs of follow-on procedures

Results

Laser Induced Fluorescence (“LIF”) Technology

Optical fiber transmits laser light via endoscope to tissue

Auto-fluorescence collected by fiber and returned to optical detector within console for analysis

OUTPUT(one second)

}

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Competitive Landscape - ColonSpectraScience

WavSTATMauna Kea

TechnologiesOlympus Medical

Fujinon

Procedure Type Endoscope Based Probe Based Endoscope Based

Endoscope Based

Technology Laser Induced Fluorescence

Confocal Microscopy

Narrow BandImaging

Confocal Endomicroscopy

Costs $0 capital cost~$175 per procedure

$125K capital cost$400+ per procedure

$125-150K capitalcost

$125-150K capitalcost

Results Suspect/Not SuspectObjective

Interpretive Subjective

InterpretiveSubjective

InterpretiveSubjective

LengthensProcedure?

No Yes Yes Yes

Interval/Specimen

One Second Three to TenMinutes

Three to TenMinutes

Three to TenMinutes

NPV 96-98% 95% 82% 84%

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Second Target Barrett’s Esophagus (Esophageal Cancer)

• Increased by 600% since 1975!

• Fastest growing cancer type, with 96% mortality

• Barrett’s esophagus is a precursor to esophageal cancer:

• U.S. prevalence of 3M+• 0.3M-0.5M new cases annually• Predicated on GERD (~40M in U.S.)

• 1.6M+ endoscopy screenings annually US

• Early detection and treatment can result in 90% cure!

Relevant Statistics

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Oncoscope More Tissue = Improve Diagnostic Yields, Save Time and Money:

3M+ US Barrett’s patients are screenedevery 6 months to 2 years

Standard of Care: Random Biopsy Oncoscope: Guided Biopsy

$

$

$

$

$

$

$

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OncoscopeDetects Early Dysplasia in Basal Layer by Enlarged Nuclear Diameters

Kelloff, et al. Nature Vol 7, 508 – 518 (2007)

9 to 13 years

Delivers smarter, targeted biopsies,requiring fewer of them

Diagnostic Area of Existing Technologies

Narrow Band Imaging

Fluorescence

Ultrasound

Pill-Cam

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Competitive Landscape – Barrett’s Esophagus

Feature SpectraScience NinePoint Mauna KeaCompatible with current procedure – –Full tissue depth –Real-time – –Automated analysis – –Dysplasia detection High Limited Manual

Cost $ $$$ $$$

Which is easiest for clinician to interpret & act upon?

SpectraScience NinePoint Mauna Kea

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Commercialization Strategy

♦ Market first to EU, then to U.S. managed care– Germany, UK and France, Middle East– Distribution agreements in place– EU markets are single-payer– Economic savings already determined by NIHR in UK

– Approximately £ 60M annually– Germany private pay physicians incentivized to use WavSTAT

♦Europe-based Director of Business Dev.– Direct sales organization in Germany, UK, France– Distribution elsewhere– Discussions regarding China, Korea, Japan

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Highlights√ Distribution agreements across Europe and Middle East√ Products address large, growing and increasingly cost-

conscious markets√ Exceed the technology adoption hurdle 96-98% NPV√ No Technology or Development Risk√ Proven technology that is faster, more accurate and less

costly √ Faster for clinician; Answer in 1 second√ Safer for the patient; Fewer biopsies & polypectomies√ Less expensive for payers

√ Platform ensures multiple products to drive growth and diversify distribution

√ Robust portfolio of Intellectual Property√ Management team with extensive experience

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Contact Information

SpectraScience, Inc.Michael Oliver,President/CEO

11568 Sorrento Valley Rd, Suite 11San Diego, CA 92121

Phone: 858-847-0200 ext. 2001

Fax: [email protected]

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Platform Technologies

♦ Complementary to current endoscopic standard of care

♦ Can be used wherever endoscopes are used for diagnosis

♦ Targets biochemical properties of tissue

Laser Induced Fluorescence (“LIF”)Lower GI (Colon)

Scattering Spectroscopy (“SS”)Upper GI (Barrett’s Esophagus)

♦ Complementary to current endoscopic standard of care

♦ Can be used wherever endoscopes are used for diagnosis

♦ Targets physical properties of tissue

♦ Best technology or combination for optimal clinical result♦ Multiple potential partners♦ Multiple distinct channels♦ Multiple markets

Multi-modal Future