8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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):  September 8, 2016

OncoCyte Corporation

(Exact name of registrant as specified in its charter)

California	1-37648	27-1041563
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

1010 Atlantic Avenue, Suite 102

Alameda, California 94501

(Address of principal executive offices)

(510) 775-0515

(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:

☐ 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))

Forward-Looking Statements

Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements.  Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in OncoCyte Corporation’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and in other filings that OncoCyte may make with the SEC.  Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change.  Except as required by law, OncoCyte disclaims any intent or obligation to update these forward-looking statements.

This Report and the accompanying Exhibit 99.1 shall be deemed “furnished” and not “filed” under the Securities Exchange Act of 1934, as amended.

Section 7 - Regulation FD

Item 7.01 - Regulation FD Disclosure

On September 8, 2016, William Annett, our Chief Executive Officer, will present information on our development of diagnostic tests for lung cancer, bladder cancer, and breast cancer at the Annual Gateway Conference on Thursday, September 8, 2016 at 3:30 p.m. Eastern Standard Time/ 12:30 p.m. Pacific Time.  The conference will be held at the Four Seasons Hotel in San Francisco.  A live webcast and subsequent archived replay of Mr. Annett’s presentation may be accessed via the investor relations section of our website.  The presentation will include the information in the slides attached to this report as Exhibit 99.1.

Section 9 - Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits.

Exhibit Number	Description
99.1	Slide presentation

SIGNATURES

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.

	ONCOCYTE CORPORATION
Date:  September 8, 2016	By:	s/William Annett
		William Annett
		Chief Executive Officer

EX-99.1

Exhibit 99.1

 Liquid Biopsies Next Generation Cancer Molecular Diagnostics  William AnnettChief Executive OfficerSeptember 2016 

 Forward Looking Statements  Statements pertaining to future financial and/or operating results, future research, diagnostic tests and technology under development, clinical development of diagnostic tests, and potential opportunities for OncoCyte Corporation and the diagnostic tests it is developing, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “may,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development, testing, marketing and/or commercialization of potential diagnostic tests, including developing or obtaining the resources and capabilities required to do so, uncertainty in the results of clinical trials, need and ability to obtain future capital, and maintenance of intellectual property rights, need to obtain approvals from federal and state regulatory agencies, and uncertainty as to reimbursements or coverage from third party payers such as Medicare, health insurance companies, and health maintenance organizations. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of OncoCyte, particularly those mentioned in the Risk Factors and other cautionary statements found in OncoCyte’s latest Annual Report on Form 10-K and other Quarterly Reports and Current Reports filed by OncoCyte with the Securities and Exchange Commission. OncoCyte disclaims any intent or obligation to update these forward-looking statements and/or this presentation, including but not limited to any changes resulting from changes in fact or circumstances. This presentation is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities of OncoCyte Corporation.  2 

 Investment Highlights  Positioned to capitalize on standard of care moving to liquid biopsyAddresses large unmet needs for early, accurate diagnosis in multiple cancersInitial focus on lung, one of the largest markets and a national health priorityCurrent lung cancer standard of care is inaccurate, risky, and expensiveStrong clinical data potentially positions OncoCyte to become standard of careCompelling value proposition for payers, physicians, and patientsOn track for first product launchDeep product pipeline leveraging core R&D competenciesExperienced leadership team with background in commercialization  3 

 Molecular diagnostics are evolving towardnon-invasive liquid biopsies  IMAGING TISSUE BIOPSY  LIQUIDBIOPSY  MammogramLDCT  VeracyteGenomic Health  4 

 Some molecular diagnostics companies have substantial valuations  Source: Bloomberg as of 5/18/2016   In some cases based on incremental improvements and/or small markets   5  OncoCyte is focused on the largest segment and the biggest market opportunity   Market Capitalization  $100M  $200M  $300M  $400M  $500M  $600M  $700M  $800M  $900M  $3000M       

 Source of revenue: The 2015 Liquid Biopsy Report Piper Jaffrey September 2015  Recurrence  $6.9B   Companion Diagnostics  $6.7B  Diagnosis  $15B  Prognostic  OncoCyte is focused on early diagnosis – the largest market segment, but with low competition  6    Prognosis  Diagnosis $15B  Companion Diagnostics$6.7B  Recurrence$6.9B 

 Lung cancer is the largest market opportunity  Largest % of global diagnostics revenue  Most cancer deaths each year in the U.S.  Cancer Diagnostics Market: Global Industry Analysis, Size, Share, and Forecast 2014-2020, Transparency Market ResearchDiagnostics include both imaging and molecular diagnostics SEER Stat fact Sheet Estimated deaths 2015  7 

 Lung cancer is typically diagnosed at later stages, limiting survival rates57% of lung cancer diagnoses are made in stage IV  Sources: Cancer SEER Stat Fact SheetsNCCN Guidelines Lung Cancer Screening 2/2014USPSTF Screening for Lung Cancer  8   Colorectal  Breast  Lung  Prostate  FDA approval for prostate progression test  FDA approval for prostate screening test  Bladder  Five year survival rate  Lung opportunity driven by poor outcomes with little improvement over the last 40 years 

 Lung cancer diagnosis is the highest unmet need  9      The most lethal cancer with one of the worst survival rates, but one of the poorest standards of care  Bubbles represent number of U.S. deaths per year  Probability of false positive test under current standard of care(leading to unnecessary and expensive follow-up procedures) 

 Early detection of lung cancer is now a national health priority because it has the highest death rate Better diagnosis will increase the survival rate and save livesDecember 2013 USPSTF guidelines recommend annual LDCTs for patients with 30 pack-year history7-10M AmericansFebruary 2015CMS announces Medicare coverage of LDCTsHowever LDCT has a high rate of false positives25% of all LDCTs are indeterminate, requiring additional procedures But 96% of indeterminate LDCTs turn out to be benign – false alarmsSo 96% of follow up procedures are unnecessary   Lung cancer is now a major U.S. health priority  10 

 Current standard of care is risky and expensive  Follow up procedures are also expensiveBiopsies via bronchoscopies, surgery, needle biopsyFrequent follow up LDCTs (radiation exposure)Lung biopsies are much riskier than other types of biopsies, and deaths could be avoided:0.5 to 1% mortality (600 to 1,300 annual deaths averted)4-20% major complications (5,000 to 26,000 fewer events annually)2-15% collapsed lung (2,600 to 20,000 fewer events annually )For an average patient a lung biopsy has a higher likelihood of leading to a serious complication than of confirming lung cancer  Source: Evaluation of Individuals with Pulmonary Nodules: When Is it Lung Cancer? Chest 2013 May; 143(5 Suppl):e83s-e120sOncoCyte absolute number estimated using TAM 10M and 65% specificity  11 

 12  Pipeline diagnostics based on platform with commercial advantages  Diagnostic Strategy  *... potentially malignant, clinician to determine follow up procedure.  

 13  High-risk patients  LDCT screening  Clear  Biopsy  Malignant  Benign nodule  Follow-upLDCT scans  Nodules  Confirmatory  USPSTF Guidelines Recommend Screening – Covered by Medicare  OncoCyte’s initial focus is on confirmatory diagnostic solution  No nodules  7-10M Americans  96% False Positive 

 Prototype classifier presented at American Thoracic Society in 2015Sensitivity: 76%Specificity: 88%Proof of concept for confirmatory diagnostic and screening diagnostic  14  Bioinformatics lab of Dr. Louise C. Showe9+ years developing blood-based tests for lung cancerSignificant sample set (3,000 samples and ongoing collection)OncoCyte exclusive global licensing agreementFollow on pivotal trial (620 subjects) completed February 2016, replicated 2015 studyResults being presented at CHEST 2016, October  OncoCyte’s preliminary test shows strong performance  

 TAM numbers based on company estimates and secondary data   15  Large market opportunity for lung tests      USPSTF guidelines for 30 pack-year smokers    All indeterminate diagnoses (LDCT +)    Downstream procedures performed on indeterminate diagnoses  Confirmatory test extended use(1.8-2.5 million patients)  Overall screening market(7-10 million patients)  Confirmatory test first launch(~180k to 250k patients)  Initial Focus 

 High clinical utility – the potential for fewer risky procedures and significant cost savings  Current Standard of Care  OncoCyte’s Test as part of Standard of Care  OncoCyte’s test could result in $1.4B to $4.0B in annual U.S. cost savings  140,000 to 380,000 fewer procedures annually9,000 to 26,000 fewer hospitalizations annually  16  *Use 1 – Confirmatory test first launch, Lung RADs 3 and 4**Use 1 and 2 – Confirmatory test first launch and expanded use, Lung RADS 2,3 and 4Assumptions: 10M patients screened, 25% positive results, molecular diagnostic with 65% specificity (OncoCyte test may have higher or lower specificity); for Use 1 and 2 all positive screens referred to downstream procedures including repeat LDCTs, PET scans, bronchoscopies, surgical biopsies, with 15% complications and associated hospitalization costs  Complications34K  Avoided complications 9-26k 

 Compelling proposition for payers  Payers gave diagnostic high ratings for unmet needs Pricing and TPP discussion with payers very positive  Asked of 10 Commercial, Managed Medicaid and Managed Medicare payers representing 20M covered livesQ8: Now I would like to ask what is your perception of the overall unmet need for certain oncology screening diagnostics or procedures. On a scale of 1 to 10 where 1 is no unmet need and 10 is significant unmet need for an improved screening procedure/diagnostic   17  “Evidence in lung screening not as well developed.”   “Getting tissue in lung biopsy is much more invasive for lung than other cancers”  “Not just about the expense, there is also increase morbidity and mortality with biopsies”  “High need driven by lack of good screening procedures and a clinical concern to identify patients earlier”  “Am concerned with USPSTF guidelines and the high false positives (one in five) and invasiveness of biopsies” 

 Compelling proposition for prescribers  Interest in using the OncoCyte test is very high with a mean rating of 8.5 out of 10Pulmonologists expressed highest interest at 9.3, followed by interventional radiologists at 8.7Reasons provided for high ratings: Useful for smaller nodules with high risk factors Provides additional accuracy and benefit Avoid biopsies Non-invasive blood test Provides clinical utility  18 

   Commercialization strategy addresses allkey stakeholders  ProviderDeterminate diagnosisHigh sensitivity High specificityReduce unnecessary procedures  PatientEarlier detectionImproved outcomesReduce anxiety over indeterminate finding  PayerImproved health outcomesFewer unnecessary proceduresReduce overall costs  Marketing Strategy  Benefits  Specialty sales forceTPP refinement via market researchPractice guidelinesPeer review journalsKOL influence  Reimbursement support out of pocketIncrease awareness to increase LDCT uptake Patient friendly test report  Pricing vs comparatorRWE clinical utility studiesCMS 1st coverage focus5 Large health plans   19 

   Research    Assay Development    R&D Validation Study    CLIA Validation    Clinical Utility Studies  Breast screening  Lung confirmatory  May materialize as confirmatory, screening, recurrence or companion diagnostic* Dependent on partnering discussions    OncoCyte launch focus  Partner focus  20  OncoCyte’s deep product pipeline  Breast confirmatory  Next 12 months R&D focus  Lung screening  Bladder  Next 12 months R&D focus*  Tumor type 4  As of September 2016  Next 12 months R&D focus    Commercial Launch  Next 9 months R&D Focus 

   21  Screening Population  ScreeningMammogram  Clear  Suspicious  DiagnosticMammogram  Clear  Suspicious  Biopsy  BIRADS 3/4  BIRADS 1/2  CONFIRMATORY  SCREENING  Breast cancer confirmatory diagnostic under development 

 Breast cancer diagnostic overview  High false-positive rate of mammography and ultrasound leads to unnecessary biopsies and increased costsTarget population: women with dense breast tissue, genetic mutations (BRCA), a family history of breast cancer, or those who have suspicious diagnostic mammogram screening results (BIRADs 3 or 4) typically sent to biopsyA simple blood test will reduce false positives sent to biopsy, thus reducing invasive procedures, patient stress and health-care costsResults of first study (100 patients) selected for a poster presentation at the San Antonio Breast Cancer Conference in December 2016Data from the initial study merits validation in a larger study Study being designed and developed A significant number of samples have been collected   22 

 TAM numbers based on company estimates and secondary data   23  Large market opportunity for iterative breast cancer diagnostic tests    Guidelines suggest annual mammogram screen    Guidelines suggest MRI (dense tissue, BRCA, family history)    Indeterminate mammograms  Confirmatory test extended use (6 million patients)  Overall screening market(38 million patients in 2014)  Confirmatory test first launch (1.6-1.9 million BIRADs 3-4)  

 ROC AUC = 0.91Sensitivity = 90%Specificity = 83%  24  Bladder prototype data presented at AACR 2015  Potential to partner development and/or commercialization of bladder cancer test 

 25  Classifier performance is strong in areas of greatest health outcome impact  High grade bladder cancer is faster growing and more likely to spread than low gradeHigh sensitivity/specificity in high grade hematuria and high grade recurrenceStudy based on 261 patients  Data from follow on study presented at ASCO June 2016 

 TAM numbers based on company estimates and secondary data   26  Large market opportunity for bladder cancer diagnostic tests    Hematuria    Cancer in remission    Indeterminate cytology results  Recurrence test (500,000 patients x2)  Screening test(3 million patients)  Confirmatory test (500,000 patients)  Current preliminary data suggest multiple test uses 

 Management team with commercial experience   William Annett CEO CEO BioFx Labs; CEO Corra Life Sciences; Managing Director Accenture Life Science; Led Commercial Strategy, Project Finance Genentech; Harvard MBAKaren Chapman VP Research Advanced Cell Technology; Origen Therapeutics; Geron Corporation; Ph. D. Johns Hopkins University School of MedicineLyssa Friedman VP Clinical and Regulatory Affairs Veracyte VP Clinical Operations, Telomere Diagnostics, VP Clinical Development Carmenta Biosciences, McKesson Oncology Network, Oncology RNLyndal Hesterberg VP Development CEO BaroFold; Carmenta Biosciences; CTO Crescendo Biosciences; EVP Thermo BioStar; Senior Director SomaLogicKristine Mechem VP Marketing Business Analytics Abbott Labs, Market Planning Genentech, Managed Care Consulting, VP Marketing and Business Development Corra Life SciencesWilliam Seltzer VP Clinical Services Lab Director Veracyte, Illumina, Counsyl, Athena DiagnosticsRussell Skibsted CFO CFO BioTime; CFO Proove Biosciences; Managing Director and CFO RSL Ventures, CFO Aeolus Pharmaceuticals; CBO Hana Biosciences; Portfolio Management Partner Asset Management Company  27  Position  Experience 

 Investment Highlights  Positioned to capitalize on standard of care moving to liquid biopsyAddresses large unmet needs for early, accurate diagnosis in multiple cancersInitial focus on lung, one of the largest markets and a national health priorityCurrent lung cancer standard of care is inaccurate, risky, and expensiveStrong clinical data potentially positions OncoCyte to develop standard of careCompelling value proposition for payers, physicians, and patientsOn track for first product launchDeep product pipeline leveraging core R&D competenciesExperienced leadership team with background in commercialization  28 

 William AnnettChief Executive OfficerWAnnett@OncoCyte.com  Liquid Biopsies Next Generation Cancer Molecular Diagnostics