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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED):
NOVEMBER 10, 2008
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XENOMICS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
FLORIDA
(STATE OR OTHER JURISDICTION OF INCORPORATION)
333-103083 04-3721895
(COMMISSION FILE NUMBER) (I.R.S. EMPLOYER IDENTIFICATION NO.)
ONE DEER PARK DRIVE, SUITE F
MONMOUTH JUNCTION, NJ 08852
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
(732) 438-8290
(REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (SEE General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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ITEM 7.01 REGULATION FD DISCLOSURE
Dr. Samuil Umansky, our chief science officer, will present at the Rodman
& Renshaw 10th Annual Healthcare Conference on November 11, 2008. Materials
expected to be used during the presentation are attached as Exhibit 99.1 to this
report.
The information in this report, including Exhibit 99.1, is being furnished
pursuant to Item 7.01 and shall not be deemed to be "filed" for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), or otherwise be subject to the liabilities of that section, nor shall it
be deemed to be incorporated by reference in any filing under the Securities Act
of 1933, as amended, or the Exchange Act.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS
(d) Exhibits.
99.1 Presentation dated November 11, 2008.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
XENOMICS, INC.
Date: November 10, 2008 By: /s/ Gary Anthony
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Gary Anthony
Vice President and Controller
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XENOMICS, INC.
SAMUIL R. UMANSKY, M.D., PH.D., CHIEF SCIENTIFIC OFFICER
RODMAN & RENSHAW 10TH ANNUAL HEALTHCARE CONFERENCE
NOVEMBER 2008
FORWARD-LOOKING STATEMENTS
Statements in this presentation about the Company's expectations, applications
of its technology, markets, launch of tests and other statements that are not
historical facts are "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934 and are based on management's current beliefs, assumptions, estimates
and projections. Actual results may differ materially from those projected in
the forward-looking statements for various reasons, including risks associated
with product and test development, test transfer to contracting labs, government
regulation, market acceptance, limited commercial experience, dependence on key
personnel, obtaining financing and other factors discussed in the Company's
periodic reports filed with the Securities and Exchange Commission.
[XENOMICS, INC. LOGO]
HIGHLIGHTS
o NOVEL APPROACH TO MOLECULAR DIAGNOSTICS
o URINE-BASED, PROPRIETARY, HIGHLY SENSITIVE TRANSRENAL DNA / RNA
(TR-DNA/RNA) TEST PLATFORM
o EXTENSIVE HUMAN DATA
o BROAD IP ESTATE
o LATE-STAGE PRODUCTS AND NEAR-TERM REVENUE
o HUMAN PAPILLOMAVIRUS (HPV) SCREENING TEST
o GENDER DETERMINATION TEST
o STRONG PIPELINE
o INFECTIOUS DISEASES
o TUMOR DETECTION AND MONITORING
o MICRORNAS (MIRNA): ALZHEIMER'S DISEASE (AD), BRAIN STROKE, KIDNEY
TRANSPLANTATION, DRUG DEVELOPMENT
o COLLABORATIONS AND PARTNERSHIPS
o RESULTS-FOCUSED MANAGEMENT TEAM WITH SCIENTIFIC AND COMMERCIAL EXPERTISE
[XENOMICS, INC. LOGO]
WHAT IS TRANSRENAL DNA?
100 BILLION CELLS DIE NATURALLY EACH DAY
NUCLEAR DNA IS BROKEN INTO PACKETS OF GENETIC MATERIAL
DNA PACKETS ARE CARRIED AWAY IN THE BLOOD STREAM
SOME OF THIS DNA IS FILTERED THROUGH KIDNEYS AND APPEARS
IN URINE AS TRANSRENAL DNA
TRANSRENAL DNA CAN BE USED FOR DIAGNOSTIC TESTING IN URINE
[XENOMICS, INC. LOGO]
ORIGINS OF "ALIEN" DNA IN URINE
FETUS HOST DNA
OR
TUMOR "ALIEN" DNA
TRANSPLANT BLOOD URINE
INFECTIONS
[XENOMICS, INC. LOGO]
"ALIEN" GENOMIC SEQUENCES DETECTED BY TR-DNA TESTS
o FETAL DNA MARKERS IN MATERNAL URINE
o TUMOR MARKERS:
o COLON AND PANCREATIC CANCERS, NASOPHARYNGEAL CARCINOMA, ACUTE
MYELOID LEUKEMIA, CERVICAL CANCER
o TRANSPLANTATION MARKERS (BLOOD TRANSFUSION)
o PATHOGENS:
o BACTERIA: MYCOBACTERIUM TUBERCULOSIS, HELICOBACTER PYLORI, BACILLUS
ANTHRACIS
o VIRUSES: HPV, HIV, EBV
o PARASITES: LEISHMANIA, PLASMODIUM
[XENOMICS, INC. LOGO]
MIRNA DETECTED IN URINE
o UBIQUITOUS MIRNA
o BRAIN-SPECIFIC MIRNA
o PLACENTA AND OTHER EMBRYO-SPECIFIC MIRNA
o LIVER-SPECIFIC MIRNA
o HEART/MUSCLE-SPECIFIC MIRNA
o VIRAL MIRNA
[XENOMICS, INC. LOGO]
PATENTS
o ISSUED
o PRENATAL DIAGNOSTICS
o TUMOR DETECTION AND MONITORING
o TRANSPLANTATION MONITORING
o INFECTIOUS DISEASES
o EUROPEAN PATENT COVERING PRENATAL DIAGNOSTICS
o PENDING
o CELL-FREE NUCLEIC ISOLATION FROM BODY FLUIDS
o METHODS FOR DETECTION OF "ULTRASHORT" DNA SEQUENCES AND THEIR
APPLICATION
o DIAGNOSTIC APPLICATIONS OF MIRNA FROM URINE AND OTHER BODY FLUIDS
o MUTANT NPM1 - MARKER FOR ACUTE MYELOID LEUKEMIA (AML)
o OTHER
[XENOMICS, INC. LOGO]
ADVANTAGES OF URINE SAMPLES
o ADVANTAGES IN EASE AND COST-EFFECTIVENESS OF SAMPLE COLLECTION AND
HANDLING INCLUDE:
o HOME-BASED COLLECTION
o COLLECTION REMOTE FROM MEDICAL INFRASTRUCTURE
o LESS TECHNICALLY DEMANDING TECHNIQUES
o NO REFRIGERATION NEEDED
o GREATLY REDUCED BIOHAZARD RISK
o EASIER PATIENT FOLLOW-UP AND RE-TESTING
o SAMPLE VOLUMES
o OPTIMALLY SUITED FOR SCREENING TESTS
o BROAD APPLICATION FOR EARLY DETECTION AND SUCCESSFUL TREATMENT
o POTENTIAL FOR WIDER MARKETS
[XENOMICS, INC. LOGO]
XENOMICS PIPELINE
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TEST PROOF-OF- TEST DESIGN CLINICAL HOMEBREW FDA APPLICATION
PRINCIPLE AND STUDY TEST
OPTIMIZATION MARKETING
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HPV
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GENDER
DETECTION
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TB
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AML/NPM1
Bone
Marrow/Blood
Tr-DNA test
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MIRNA TESTS
Brain Stroke
Alzheimer's
Kidney
Transplantation
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[XENOMICS, INC. LOGO]
COMMERCIAL ACTIVITY
o LAUNCH OF LAB-DEVELOPED TESTS IN 2009
o HPV (INDIA)
o GENDER DETERMINATION (US)
o OTHER
o PRENATAL APPLICATIONS LICENSED TO SEQUENOM
o BONE MARROW/BLOOD-BASED AML TEST LICENSED TO LABCORP
o CO-EXCLUSIVE LICENSE FOR AML KIT DEVELOPMENT
o ASURAGEN AND IPSOGEN
o DNA ISOLATION KIT
o ACTIVE ONGOING DISCUSSIONS WITH POTENTIAL PARTNERS
[XENOMICS, INC. LOGO]
HPV: MARKET
o AT PRESENT, ~65 MILLION PAP SMEAR AND ~10 MILLION HPV TESTS ARE PERFORMED
ANNUALLY IN THE US
o CURRENT STANDARD HPV TEST (DIGENE) IS USED IN CONJUNCTION WITH
CERVICAL SAMPLES AND PAP SMEAR TEST
o HPV TEST MARKET IN INDIA PRESENTS A MAJOR COMMERCIAL OPPORTUNITY
o CERVICAL CANCER IS THE MOST PREVALENT CANCER
o CULTURAL BARRIERS TO TESTING
o 400 MILLION ELIGIBLE WOMEN; ESTIMATED 8 MILLION INITIALLY ACCESSIBLE
o LARGELY UNDEVELOPED MARKET - COMPETITION (DIGENE, ROCHE, THIRD WAVE)
RELIES ON CERVICAL SAMPLES FACING CULTURAL BARRIERS TO TESTING
[XENOMICS, INC. LOGO]
XENOMICS HPV ASSAY:
CAPILLARY ELECTROPHORESIS
[HPV positive LINE GRAPH] [HPV negative LINE GRAPH]
[XENOMICS, INC. LOGO]
HPV: CLINICAL STUDY RESULTS
o 77.5% concordance with Digene test
o Sequencing data: fewer false-positive and false-negative results
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URINE HPV TEST RESULTS
NO. OF SAMPLES TOTAL
DIGENE -------------------------------
RESULTS POSITIVE NEGATIVE
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POSITIVE 103 39 142
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NEGATIVE 33 145 178
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CONCORDANCE 103 145 248 (77.5%)
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[XENOMICS, INC. LOGO]
HPV: INITIAL COMMERCIAL STRATEGY
o FORM ALLIANCE WITH METROPOLIS HEALTH SERVICES TO OFFER LAB-DEVELOPED TEST
IN INDIA
o SALES AND MARKETING
o ARRANGE FOR CONTRACT SALES AND MARKETING SERVICES
o EMPHASIS ON EDUCATION
o FOCUS ON PHYSICIAN AND INDEPENDENT LABORATORIES
o BRIDGE TO DEVELOPMENT OF A KIT FOR THE US AND OTHER MARKETS
o ADVANTAGES XENOMICS HPV SCREENING TEST
o HIGHER SENSITIVITY
o COST EFFECTIVENESS
o NO DOCTOR VISIT AND CERVICAL CELL COLLECTION NEEDED
o OVERCOMES CULTURAL BARRIERS
o POTENTIAL FOR MALE HPV CARRIER ASSAY
o VACCINATED POPULATION MONITORING
[XENOMICS, INC. LOGO]
XENOMICS GENDER DETERMINATION TEST
o SCIENTIFIC AND CLINICAL PROOF-OF-CONCEPT FOR TR-DNA TECHNOLOGY
o PROVIDES RESULTS AS EARLY AS AT THE 6TH WEEK OF PREGNANCY (VS. 12 WEEK FOR
ULTRASOUND)
o CLINICAL STUDY RESULTS
o EARLY DETECTION - THROUGH WEEK 12:
o SENSITIVITY: 21/22 (95.5%) MALE DETECTED
o SPECIFICITY: 18/19 (94.7%) FEMALE NOT DETECTED
o TOTAL:
o SENSITIVITY: 116/123 (94.3%) MALE DETECTED
o SPECIFICITY: 102/119 (85.7%) FEMALE NOT DETECTED
[XENOMICS, INC. LOGO]
GENDER DETERMINATION: COMMERCIAL STRATEGY
o OFFER LAB-DEVELOPED TEST THROUGH CONTRACTING LABS [SCREEN]
o SALES AND MARKETING
o DIRECT-TO-CONSUMER MARKET
o E-COMMERCE SALES PORTAL
o POTENTIAL RETAIL PORTAL
o TARGET PRICE PER TEST ~ $225 - 275
o 6.2 MILLION PREGNANCIES PER YEAR IN THE U.S.
o SURVEY CONDUCTED IN THE UK INDICATES ~ 20% OF PREGNANT WOMEN WOULD
TAKE A TEST WITH A PRICE OF $200-400
o NO NON-INVASIVE DNA-BASED TEST IS CURRENTLY AVAILABLE
[XENOMICS, INC. LOGO]
SELECTED PROJECTS IN DEVELOPMENT
o TUBERCULOSIS
o MIRNA APPLICATIONS
o ALZHEIMER'S DISEASE
o BRAIN STROKE MONITORING
o KIDNEY TRANSPLANTATION MONITORING
o TOXICOLOGY AND DRUG DEVELOPMENT
o ACUTE MYELOID LEUKEMIA: TR-DNA-BASED MONITORING TEST
o TECHNOLOGY DEVELOPMENT
o COMMERCIAL URINARY DNA AND RNA ISOLATION KITS
o SAMPLE COLLECTION, TRANSPORTATION, AND PARTIAL INTEGRATION WITH
NUCLEIC ACID ISOLATION
o NEW APPROACHES FOR DETECTION AND QUANTIFICATION OF SHORT NUCLEIC
ACID FRAGMENTS
[XENOMICS, INC. LOGO]
DETECTION OF TB
[GRAPH]
1. TBX01 (AFB-, Culture-)
2. TBX02 (AFB-, Culture-)
3. TBX03 (AFB-, Culture-)
4. TBX05 (AFB+, Culture+)
5. TBX07 (AFB+, Culture+)
6. TBX08 (AFB+, Culture+)
7. Local Donor
8. Buffer Control
9. 500 copies TB gDNA
10.50 copies TB
11.5 copies TB
12.NTC
[XENOMICS, INC. LOGO]
BRAIN-SPECIFIC TR-MIRNA AFTER STROKE
[GRAPH]
[XENOMICS, INC. LOGO]
COMPETITIVE LANDSCAPE
TEST COMPANIES COMMENTS
HPV QIAGEN/DIGENE DNA OR RNA
GEN-PROBE FROM CERVICAL CELLS
ROCHE MOL. DIAG.
THIRD WAVE
SENSIGEN/SEQUENOM
IKONISYS
TUBERCULOSIS ROCHE MOL. DIAG. SPUTUM DNA OR RNA
GEN-PROBE FOR AFB+ PATIENTS WITH
BECTON-DICKINSON PULMONARY TB ONLY
QIAGEN/ARTUS
TRANSPLANTATION NONE CURRENTLY BIOPSY IS THE ONLY
TECHNIQUE USED FOR DETECTION
OF REJECTION EPISODES
ALZHEIMER'S DISEASE NONE COGNITIVE FUNCTION AND
IMAGING ANALYSIS ARE
CURRENTLY USED, THERE IS NO
MOLECULAR TEST
[XENOMICS, INC. LOGO]
12 MONTHS MILESTONES
o ESTABLISH MARKETING PARTNERSHIP FOR GENDER DETERMINATION TEST; LAUNCH THE
TEST IN THE US
o INITIATE A DIALOGUE AND MEET WITH FDA TO DISCUSS DEVELOPMENTAL PATH FOR
HPV SCREENING TEST
o LAUNCH HPV TEST IN INDIA
o MOVE TB, AD, TRANSPLANTATION MONITORING TESTS INTO LATER STAGE OF
DEVELOPMENT
o REGAIN A REPORTING STATUS
o BRING ADDITIONAL FUNDS INTO THE COMPANY
[XENOMICS, INC. LOGO]
XENOMICS VALUE PROPOSITION
o XENOMICS HAS DEVELOPED BROAD PROPRIETARY PLATFORM TECHNOLOGY BASED OF
TRANSRENAL NUCLEIC ACID ANALYSIS
o BASIC TECHNIQUES FOR TR-DNA/RNA ISOLATION AND ANALYSIS HAVE BEEN DEVELOPED
o HPV AND GENDER DETECTION TESTS ARE IN IMPLEMENTATION STAGE
o SEVERAL TESTS ARE IN CLINICAL STUDIES OR UNDER DEVELOPMENT
[XENOMICS, INC. LOGO]
THANK YOU!
XENOMICS, INC.
RODMAN & RENSHAW 10TH ANNUAL HEALTHCARE CONFERENCE
NOVEMBER 2008