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History (brief)History (brief)
CytoCore, is a cervical and uterine cancer screening,
diagnostic and treatment company founded in 2000 $40mm in equity raised to date
Management changes caused delays needed to refocus
Technology and market opportunity made it worth theeffort to save
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Turnaround and Progress from 9/05Turnaround and Progress from 9/05
Re-launched projects for e2 Collector and AIPS Platform
Cleaned up balance sheet debt
Signed Unrestricted License on 2 new products from UHCand Dr. Gorodeski (Bio-marker & Drug Delivery System)
Opening basic research lab facility at UHC to be run byDr. Gorodeski
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Our principal Markets
Cervical and Uterine Cancer Tests for Women
Our principal Markets
Cervical and Uterine Cancer Tests for Women
Pap Test Facts
History, developer: George Papanicolaou, MD, in 1940s,
which resulted in dramatic reduction in cervical cancer deaths
Cervical Cancer Screening and Treatment is $7BB+ in US
180MM Pap tests done WW
75-80MM in US
Rest mostly in Europe/Japan/Canada/Australia
1.5-1.8 BB women should get PAP test
Principal reason they are not tested is lack of labs andcytologists
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Cervical Cancer Detection and TreatmentCervical Cancer Detection and Treatment
$3.6 Billion
$3.0 Billion
$1.0
Billion
Resolving ~ 10%Questionable Pap
Tests (ASCUS)
Resolving ~ 10%Questionable Pap
Tests (ASCUS)Pap TestScreening
Pap TestScreening
Follow-up Colposcopy& Surgical ProceduresFollow-up Colposcopy& Surgical Procedures
$7.6 Billion Annual Expenditures in US - 70-80mm Pap tests in US- 100mm in Rest of World
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Elements of PAP TestElements of PAP Test
Same basic technology for past 50 years
Cell Collection by Physician in office using spatula/brush
Cells sent to lab for preparation of slide (Cytecs Thin Prep) Cytopathologist views slide looking for abnormal differences in
cell shapes (accuracy ranges from 50-70%)
Apx. 10% of Pap Tests are deemed abnormal. Results sentback to Physician
Abnormal PAP requires additional exam of patient (if highgrade lesion, surgery is result, or go home and wait)
Only new addition is recent HPV test which tests woman forHPV virus, but does not change need for the PAP test
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InPath System for Pap TestInPath System for Pap Test
4 Part system (Collector/Markers/AIPS/DDS)
Identification(Laboratory)
e2 Collector(FDA-approved)
CVX/P2X7
Bio-Marker
AIPS
Platform
Drug Delivery
System
Collection(Physicians
office)
Treatment(Physicians
office)
Screening(Laboratory)
Nothing remotely like InPath System on the market;it addresses and upgrades each component of the Pap test
while offering a true end to end solution.
Nothing remotely like InPath System on the market;it addresses and upgrades each component of the Pap test
while offering a true end to end solution.
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1st Component ofInPath System:
e2 Collector
1st Component ofInPath System:
e2 Collector
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e2 Collector: Unique Advantages for Pap Teste2 Collector: Unique Advantages for Pap Test
Biggest single source of errors (variable) in Pap test is bad sampling
at 1
st
step of test: how good is the doctors collection techniquewith current brush/spatula?
e2-Collectors balloon expansion properties reaches total surface ofcervix. BY DESIGN e2 Collector is much less technique dependent
By reducing dependency on technique, e2 Collector deliversconsistently better collection of cells and therefore a more accuratePap test
FDA trial proved e2 Collector gets better cell sample for more
accurate Pap test (zero false positives, one third the false negatives)
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e2 Collector: Market, Competition & Opportunitye2 Collector: Market, Competition & Opportunity
Annual Pap tests
70-80MM tests in US
100MM Rest of World
Pap tests spatula & brush are given away. No competitor will bedefending market share.
New HPV test alerts high-risk women who test positive (35-50%+ ofthose tested); Collector could be pulled into market by this group
Much of todays new product adoption is based on reducing doctorsliability by using best standard of care available as benchmark
e2 Collector could become best standard of care available becauseof increased cell collection accuracy
Expect to partner with major distributor to laboratories in sector thatdistribute supplies for Pap tests to doctors
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e2 Collector: Manufacturing, Costs and Profite2 Collector: Manufacturing, Costs and Profit Ready for manufacturing tooling process: 16-20 weeks
to begin manufacturing
Estimate ready for first product sales late Q4
Cost of Pap test currently runs from $70 to $350
depending on Lab and Doctor OBGYN/Gynecologist investors say at $10, it will be a
good sale as it provides a more accurate Pap Test
Sale price of Balloon Disposable est. at $5-6/unitwholesale
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2nd Component:
Bio-Marker - P2X7
2nd Component:
Bio-Marker - P2X7
P2X7 is new apoptotic marker (apoptosis vs. proliferation), basedon down regulation of receptor behavior unique discovery
Marker has shown very accurate results for all forms of uterineand cervical cancers
Assay combo shows great accuracy by triangulating cancer cellsusing different markers; one up regulated (proliferation), onedown regulated (apoptosis). P2X7 Marker will be combined withCVX markers (EGFR/IGFR) as new InPath Assay
Marker shows early but consistent indications it may be generic toepithelial cells throughout the body. Early limited results are positive
as screen test for bladder, lung and breast cancers. More testing thissummer
P2X7 is being developed as Endometrial Cancer Screen. Currently,no screen available in market for Uterine Cancers.
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Statistical Analysis of Initial Lab StudyStatistical Analysis of Initial Lab Study
482325Total
2020 TN0 FNNegative
283 FP25 TPPositive
Total
NormalCancerProtein
511536Total
1715 TN2 FNNegative
340 FP34 TPPositive
TotalNormalCancerRNA
p
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Co-Culture: Human Normal Keratinocytes PLUS Skin Squamous
Carcinoma Cells
Co-Culture: Human Normal Keratinocytes PLUS Skin Squamous
Carcinoma Cells
EGFR P2X7
EGFR + P2X7
Trials beginning by end of this year, est. 12-18 months
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3rd Component:
AIPS Platform (2nd generation)Automated Image Proteomic System
3rd Component:
AIPS Platform (2nd generation)Automated Image Proteomic System
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AIPS CapabilitiesAIPS Capabilities
Fully automated slide scanning and screening capability (X,Y,Zaxis), with capacity for 120 slides and bar code reader
Supports both fluorescent and white light
Supports all major microscope brands (Olympus, Zeiss or Nikon)
User controls for examining single slide with zoom capability
Software supports slide scanning, image analysis and data review
Image Analysis module can be customized for other bio-markers
Software incorporates multiple user defined billing options
AIPS supports data review via tele-pathology package
Ready for first manufacturing, sales or partnering fall 06
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4th Component:
Drug Delivery System
4th Component:
Drug Delivery System
Device:
Uses 2nd generation of e2 Collector handle to deposit . . . .
Medical Patch (FDA approved) onto the cervix . . .
Delivering choice of (FDA approved) drug compounds
Chemotherapy drugs (range of compounds and strengths)
Anti-Viral (anti-HVP) drugs
Immuno-enhancement products
Patent pending - Licensed from Dr. Gorodeski and UHC
Market is abnormal Pap tests, apx 10% or 6-8mmtests/yr.
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Drug Delivery System - DiagramDrug Delivery System - Diagram
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Drug Delivery System EngineeringDrug Delivery System Engineering
A
B
C
D
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Drug Delivery System UniquenessDrug Delivery System Uniqueness
Apx. 10% of Pap tests are positive or abnormal: ~ 6-8mm/year
Physicians ONLY options: surgery (colposcopy) or wait and see
For first time, DDS will provide a therapeutic treatment option for mild,
moderate and some high grade cervical lesions 85-90% of cervical lesions can be treated therapeutically.
Patch will allow for choice of chemo, anti-viral or immuno drugs
Company expects interest from Pharma to help develop, test and fund
compound options and trials, in exchange for their filing a patent on newcompounds
CytoCore has substantial marketing leverage. OBGYNs will use CytoCoresother products: e2 Collector, Drug Delivery System and Uterine CancerScreen.
Treatment cost ~ $100/patient
Market potential is $800MM/year in US. with no direct therapeuticcompetition.
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P2X7 Bio-Marker Unique Uterine Cancer ScreenP2X7 Bio-Marker Unique Uterine Cancer Screen
P2X7 Bio-marker shows very high accuracy in identifying all three types ofEndometrial Cancers
When woman shows symptoms (abnormal bleeding), there is NO screen ortest for Uterine cancer only biopsy, pathologist exam and surgery (either
hysterectomy or D&C) Uterine cancers are more aggressive, and because there is no screen test,
harder to detect than cervical cancers, and therefore deadlier. 40,000uterine cancers/yr in US. vs. 6,000 cervical cancers. There is a real need!
Age Group most affected is from 35 65 years of age Women with one or more of following symptoms should be tested annually:
obese, diabetic, hypertensive, abnormal bleeding, history of hyperplasia orpolyps or hormonal diseases, taking hormonal supplements
These groups represent apx. 35-40% of all women in age range. Thatwould be 20-24mm women needing to be tested annually
Digenes $100 HPV virus test is good comparable not a cancer screen
Uterine Cancer Screen represents a $2.0 BB+ market opportunity forCytoCore.
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Uterine Cancer Scan Test planUterine Cancer Scan Test plan
Plans are for initial trial this summer completed in 4-5months. Company expects to start and complete firsttrial by year end
Expect to have several top sites as partners in the trial:university medical sites and teaching hospitals
Company is working on new device to expand the easeand accuracy of current uterine tissue collection method
Uterine cancer scan should be available late 07
Distribution channel and users are same doctors as e2Collector and drug delivery device, offering potential forrapid adoption
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Product Development PlansProduct Development Plans
E2 Collector - manufacturing and sales starting end of 06
AIPS Platform manufacturing and sales Q4 06 Endometrial Cancer Screen - Based on P2X7 bio-marker,
development and trials fast tracked to last 12-15 months.Endometrial Cancer Screen targeted for sales by end of 2007
Drug Delivery System - Handle development 6-12months, patch development and testing 12-18 months (inparallel with handle), Trials will take (12-18 months)
CVX/P2X7 Cervical Screen - Bio-Marker Cocktail trialsstarting by Q4, expected to last 12-18 months; early use willbe in labs as parallel test for existing PAP test
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CytoCore Is Assembling a Professional TeamCytoCore Is Assembling a Professional Team
Medical Advisory Board
George Gorodeski, MD/PhD, inventor of Collector, DDS, P2X7
Steven Waggoner, MD, Gynecologic Oncology, rated one of the topwomen's doctors in the country for last 6 years, reviewer forObstetrics and Gynecology, Gynecologic Oncology, Cancer, Lancet
Jorge Leon, PhD, biomolecular scientist, co-founded Quest genomedivision; consultant to CCI
Consultants:
Dick Dominic, PhD: biomolecular consultant Chicago, specialty incommercializing Bio-Markers
Roberta Speyer: CEO of OBGYN.net, largest GYN site on web.Marketing specialist to GYN Sector
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