INPATH E2 COLECTOR

7/30/2019 INPATH E2 COLECTOR

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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


3/25

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


4/25

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


5/25

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


6/25

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


7/25

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.


8/25

1st Component ofInPath System:

e2 Collector

1st Component ofInPath System:

e2 Collector


9/25

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)


10/25

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


11/25

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


12/25

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.


13/25

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


14/25

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


17/25

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.


18/25

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.


21/25

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.


22/25

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


23/25

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


24/25

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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Documents

INPATH E2 COLECTOR