0001140361-16-059414.txt : 20160330 0001140361-16-059414.hdr.sgml : 20160330 20160330081015 ACCESSION NUMBER: 0001140361-16-059414 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20160330 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160330 DATE AS OF CHANGE: 20160330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OncoCyte Corp CENTRAL INDEX KEY: 0001642380 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 271041563 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37648 FILM NUMBER: 161537050 BUSINESS ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY STREET 2: SUITE 100 CITY: ALAMEDA STATE: CA ZIP: 94502 BUSINESS PHONE: 510-521-3390 MAIL ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY STREET 2: SUITE 100 CITY: ALAMEDA STATE: CA ZIP: 94502 8-K 1 form8k.htm ONCOCYTE CORPORATION 8-K 3-30-2016

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):  March 30, 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 Form 10 filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and 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 2 - Financial Information

Item 2.02 - Results of Operations and Financial Condition

On March 30, 2016, OncoCyte Corporation issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2015.  A copy of the press release is attached as Exhibit 99.1, which, in its entirety, is incorporated herein by reference.

Section 9 - Financial Statements and Exhibits

Item 9.01 - Financial Statements and Exhibits.

Exhibit Number
Description
99.1
Press release dated March 30, 2016

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:  March 30, 2016
By:
s/Russell Skibsted
 
   
Russell Skibsted
 
   
Chief Financial Officer
 

Exhibit Number
Description
Press release dated March 30, 2016
 
 

EX-99.1 2 ex99_1.htm EXHIBIT 99.1

Exhibit 99.1
 
OncoCyte Corporation Reports Full Year 2015 Financial Results

Alameda, CA – (March 30, 2016) – OncoCyte Corporation (NYSE MKT: OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, reported its financial results for the year ended December 31, 2015.

“We made significant progress in 2015 on the road to commercialization of our potential molecular diagnostics products.  We presented the initial data for our diagnostics for lung and bladder cancer, raised $11.65 million in capital, solidified our leadership team and board, and successfully listed on the NYSE MKT,” said William Annett, Chief Executive Officer.

“For the remainder of 2016 we are focused on achieving a number of key milestones.  These milestones include the completion of the validation study for our lung cancer diagnostic, and establishment and regulatory certification of a diagnostic testing laboratory, with the goal of launching a confirmatory diagnostic test for lung cancer during the first half of 2017. Concurrent with these activities is the assay development work on our breast cancer diagnostic and advancing our bladder cancer diagnostic, which reflects OncoCyte’s deep product pipeline,” concluded Mr. Annett.

Recent Accomplishments

· OncoCyte and the Wistar Institute entered into a definitive global licensing agreement for a simple, non-invasive, blood test to aid physicians in the early detection of lung cancer. The agreement provides OncoCyte the exclusive rights to commercialize this lung cancer diagnostic test.

· On December 31, 2015, BioTime, Inc. (NYSE MKT: BTX), distributed approximately 4.75 million shares of OncoCyte common stock to BioTime shareholders in the ratio of one share of OncoCyte common stock for every 20 BioTime common shares owned.  There are now approximately 25.4 million shares of OncoCyte outstanding.

· OncoCyte’s common stock began trading on the NYSE MKT under the symbol “OCX.”  The Company’s management rang the Opening Bell at the New York Stock Exchange on Wednesday, January 6, 2016 in celebration of it becoming a publicly traded company.

Full Year 2015 Financial Results
 
The net loss for the year ended December 31, 2015 was $8.7 million, or $0.42 per share, compared to $5.0 million, or $0.27 per share, in 2014.

Research and development expenses for the year ended December 31, 2015 increased to $4.5 million from $4.0 million for the same period in 2014. Overall the increase in research and development expenses was due to increased staffing and costs of clinical trials as part of the development of OncoCyte’s cancer diagnostic tests.
 

General and administrative expenses for the year ended December 31, 2015 increased to $4.2 million from $1.0 million for the same period in 2014. These increases are primarily as a result of increased staffing, including both management and consulting personnel, and costs related to OncoCyte’s common stock becoming publicly traded in December 2015.

At December 31, 2015, OncoCyte had $8.0 million of cash and cash equivalents and available-for-sale securities valued at $2.5 million.  The Company had 25.4 million shares outstanding on December 31, 2015.

About OncoCyte Corporation

OncoCyte is primarily focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients.

While current biopsy tests use invasive surgical procedures to provide tissue samples in order to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples. OncoCyte’s pipeline products are intended to be confirmatory diagnostics for detecting lung, bladder and breast cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer.

Forward Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for OncoCyte, 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,” “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 and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital,  maintenance of intellectual property rights, and obtaining third party reimbursement for patients ’use of any diagnostic tests we commercialize. 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 cautionary statements found in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements.
 
Investor Contact:

EVC Group, Inc.
Michael Polyviou/Chris Dailey
646-445-4800
mpolyviou@evcgroup.com /cdailey@evcgroup.com
 

ONCOCYTE CORPORATION
STATEMENTS OF OPERATIONS
(In thousands, except per share data)

   
Three Months Ended December 31,
(unaudited)
   
Year Ended December 31,
 
OPERATING EXPENSES
 
2015
   
2014
   
2015
   
2014
 
Research and development
 
$
1,429
   
$
1,124
   
$
4,527
   
$
3,962
 
General and administrative
   
2,110
     
372
     
4,191
     
1,011
 
Total operating expenses
   
3,539
     
1,496
     
8,718
     
4,973
 
                                 
Loss from operations
   
(3,539
)
   
(1,496
)
   
(8,718
)
   
(4,973
)
                                 
OTHER EXPENSES, NET
                               
Interest expense, net
   
(3
)
   
(1
)
   
(19
)
   
(2
)
Other expenses, net
   
3
     
(10
)
   
2
     
(11
)
Total other expenses, net
   
-
     
(11
)
   
(17
)
   
(13
)
                                 
NET LOSS
 
$
(3,539
)
 
$
(1,507
)
 
$
(8,735
)
 
$
(4,986
)
                                 
Basic and diluted net loss per share
 
$
(0.14
)
 
$
(0.08
)
 
$
(0.42
)
 
$
(0.27
)
                                 
Weighted average shares outstanding: basic and diluted
   
24,586
     
18,200
     
21,009
     
18,200
 
 

ONCOCYTE CORPORATION
BALANCE SHEETS
(In thousands)

 
ASSETS
 
December 31,
2015
   
December 31,
2014
 
CURRENT ASSETS
           
Cash and cash equivalents
 
$
7,996
   
$
257
 
BioTime shares held as available-for-sale securities, at fair value
   
2,541
     
3,280
 
Prepaid expenses and other current assets
   
388
     
114
 
Total current assets
   
10,925
     
3,651
 
                 
NONCURRENT ASSETS
               
Intangible assets, net
   
1,230
     
1,472
 
Equipment and furniture, net
   
576
     
118
 
TOTAL ASSETS
 
$
12,731
   
$
5,241
 
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
               
CURRENT LIABILITIES
               
Amount due to parent, BioTime
 
$
807
   
$
5,735
 
Amount due to affiliates
   
40
     
154
 
Accounts payable
   
285
     
144
 
Accrued expenses and other current liabilities
   
1,182
     
282
 
Total current liabilities
   
2,314
     
6,315
 
                 
TOTAL LIABILITIES
   
2,314
     
6,315
 
                 
Commitments and contingencies
               
                 
STOCKHOLDERS’ EQUITY (DEFICIT)
               
Preferred stock, no par value, 5,000 shares authorized; none issued and outstanding
   
-
     
-
 
Common stock, no par value, 50,000 shares authorized; 25,391 and 18,200 shares issued and outstanding at December 31, 2015 and 2014, respectively
   
34,901
     
15,147
 
Accumulated other comprehensive loss on available-for-sale securities
   
(350
)
   
(822
)
Accumulated deficit
   
(24,134
)
   
(15,399
)
Total stockholders’ equity (deficit)
   
10,417
     
(1,074
)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
 
$
12,731
   
$
5,241