0001140361-16-075898.txt : 20160811 0001140361-16-075898.hdr.sgml : 20160811 20160811161722 ACCESSION NUMBER: 0001140361-16-075898 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160811 DATE AS OF CHANGE: 20160811 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: 161824847 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 8-11-2016

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): August 11, 2016

OncoCyte Corporation
(Exact name of registrant as specified in its charter)

California
1-37648
27-1041563
(State or other jurisdiction
(Commission File Number)
(IRS Employer
of incorporation)
 
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-K 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 August 11, 2016 OncoCyte Corporation issued a press release announcing its financial results for the three and six months ended June 30, 2016 and announcing that it will host a conference call and webcast on Thursday, August 11, 2016, at 5:00 p.m. ET/2:00 p.m. PT to discuss financial and operating results and recent corporate developments. A copy of the press release, which explains how to access or participate in the conference call and webcast is attached as Exhibit 99.1 and is, in its entirety, 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 August 11, 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: August 11, 2016
By:
s/Russell Skibsted
 
   
Russell Skibsted
 
   
Chief Financial Officer
 

Exhibit Number Description
99.1 Press release dated August 11, 2016
 
 

EX-99.1 2 ex99_1.htm EXHIBIT 99.1

Exhibit 99.1



OncoCyte Reports Second Quarter 2016 Financial Results

 Conference Call to Discuss the Results at 5:00 p.m. ET

ALAMEDA, Calif., Aug. 11, 2016 (GLOBE NEWSWIRE) — OncoCyte Corporation (NYSE MKT: OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, today reported its financial results for the second quarter ended June 30, 2016 along with an update on recent corporate developments.

“During the second quarter we reported positive data for our lung and bladder cancer diagnostic tests, which demonstrates the depth of our product pipeline,” commented William Annett, Chief Executive Officer. “This reaffirms our view that our non-invasive diagnostic tests could improve the current medical standard of care by providing better patient outcomes and reducing costs to the healthcare system. In the third quarter we initiated the analytical verification study for our lung cancer diagnostic and are planning to complete this process later in the year. Assuming a successful conclusion, we will continue to progress towards the commercial launch of our lung cancer test in the first half of 2017.”

Recent Operating and Financial Highlights

· Presented positive bladder cancer diagnostic data at the 2016 American Society of Clinical Oncology (ASCO) annual meeting. The results were highly impressive: 100 percent accuracy in detecting high-grade lesions within the 241 patient group studied, and there was also high accuracy in the detection of low-grade lesions, with 77 percent for screening and 75 percent for recurrence.

· Announced that data from a recent study of the lung cancer diagnostic test being developed by OncoCyte and The Wistar Institute will be presented at the American College of Chest Physician’s CHEST 2016 annual meeting, which will be held in Los Angeles this October.

· Initiated the analytical verification study for its lung cancer diagnostic test, the next step in a process to independently validate the positive research results from The Wistar Institute’s study which was announced in April. OncoCyte expects to complete the process in the fourth quarter of 2016.

Second Quarter 2016 Financial Results

OncoCyte is still in the development stage and will not generate revenue unless it is able to monetize its cancer diagnostic tests. The net loss for the quarter ended June 30, 2016 was $2.5 million, or ($0.10) per share compared to a net loss of $1.4 million, or ($0.07) per share, in 2015.

Research and development expenses for the quarter ended June 30, 2016 increased to $1.2 million from $0.9 million for the same period in 2015. These increases were primarily the result of increased spending on outside research services, scientific consulting services, clinical trial related expenses, and laboratory expenses. General and administrative expenses increased to $1.3 million from $0.5 million for the same period in 2015. The increase is primarily due to salary and payroll related expenses and general consulting expenses. Operating expenses for the quarter ended June 30, 2016 included $340,000 of non-cash expenses such as stock-based compensation, depreciation of laboratory equipment, and amortization of intangible assets.
 


At June 30, 2016, OncoCyte had $4.0 million of cash and cash equivalents and $1.6 million worth of available-for-sale securities.

Six Month 2016 Financial Results

The net loss for the six months ended June 30, 2016 was $5.5 million, or ($0.22) per share, compared to $2.8 million, or ($0.13) per share, in the first six months of 2015. Research and development expenses for the six months ended June 30, 2016 increased to $2.9 million from $2.0 million for the same period in 2015. These increases were primarily the result of increased spending on outside research services, scientific consulting services, clinical trial related expenses, and laboratory expenses. For the six months ended June 30, 2016, general and administrative expenses increased to $2.6 million from $0.8 million for the same period in 2015, primarily as a result of increased salary and payroll related expenses, general consulting expenses, accounting and audit related expenses, transfer agent, stock listing and SEC filing expenses. Operating expenses for the six months ended June 30, 2016 included $536,000 of non-cash expenses such as stock-based compensation, depreciation of laboratory equipment, and amortization of intangible assets.

Conference Call

OncoCyte will host a conference call and webcast today, Thursday, August 11, 2016, at 5:00 p.m. ET/2:00 p.m. PT to discuss financial and operating results and recent corporate developments.

For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 877-524-8416. For international participants outside the U.S./Canada, the dial-in number is 412-902-1028. For all callers, refer to Conference ID 13642081. To access the live webcast, go to http://investors.oncocyte.com/events-and-presentations.

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 877-660-6853; international callers dial 201-612-7415. Use the Conference ID 13642081. Additionally, the archived webcast will be available at http://investors.oncocyte.com/events-and-presentations.

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

Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) are forward-looking statements. These statements include those pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for OncoCyte, including our ability to develop an assay and classifier for our confirmatory lung diagnostic, complete an internal validation study and implement commercialization plans and the timing of these plans. These statements are based on our current expectations, beliefs, goals, plans, or prospects and 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, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain 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 “Risk Factors” found in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements, except as may be required by law.

(Tables to Follow)
 


ONCOCYTE CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2016
   
2015
   
2016
   
2015
 
EXPENSES:
                       
Research and development
 
$
(1,195
)
 
$
(886
)
 
$
(2,884
)
 
$
(2,004
)
General and administrative
   
(1,337
)
   
(519
)
   
(2,580
)
   
(769
)
Total operating expenses
   
(2,532
)
   
(1,405
)
   
(5,464
)
   
(2,773
)
                                 
Loss from operations
   
(2,532
)
   
(1,405
)
   
(5,464
)
   
(2,773
)
                                 
OTHER INCOME (EXPENSES), NET
                               
Interest income (expense), net
   
(11
)
   
(6
)
   
(7
)
   
(7
)
Total other income (expenses), net
   
(11
)
   
(6
)
   
(7
)
   
(7
)
                                 
NET LOSS
 
$
(2,543
)
 
$
(1,411
)
 
$
(5,471
)
 
$
(2,780
)
                                 
Basic and diluted net loss per share
 
$
(0.10
)
 
$
(0.07
)
 
$
(0.22
)
 
$
(0.13
)
                                 
Weighted average common shares outstanding: basic and diluted
   
25,427
     
21,200
     
25,411
     
21,200
 
 


ONCOCYTE CORPORATION
CONDENSED BALANCE SHEETS
(IN THOUSANDS)

   
June 30,
2016
(Unaudited)
   
December 31,
2015
(Note 1)
 
ASSETS
           
CURRENT ASSETS
           
Cash and cash equivalents
 
$
4,000
   
$
7,996
 
BioTime shares held as available-for-sale securities, at fair value
   
1,617
     
2,541
 
Prepaid expenses and other current assets
   
131
     
388
 
Total current assets
   
5,748
     
10,925
 
                 
NONCURRENT ASSETS
               
Intangible assets, net
   
1,109
     
1,230
 
Equipment and furniture, net
   
514
     
576
 
Deposits
   
54
     
-
 
TOTAL ASSETS
 
$
7,425
   
$
12,731
 
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
CURRENT LIABILITIES
               
Amount due to parent, BioTime
 
$
1,688
   
$
807
 
Amount due to affiliates
   
161
     
40
 
Accounts payable
   
192
     
285
 
Accrued expenses and other current liabilities
   
500
     
1,182
 
Capital lease liability current portion
   
173
     
-
 
Total current liabilities
   
2,714
     
2,314
 
                 
Capital lease liability, net of current portion
   
244
     
-
 
TOTAL LIABILITIES
   
2,958
     
2,314
 
                 
Commitments and contingencies
               
                 
STOCKHOLDERS’ EQUITY
               
Preferred stock, no par value, 5,000 shares authorized; none issued and outstanding
   
-
     
-
 
Common stock, no par value, 50,000 shares authorized; 25,431 and 25,391 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
   
35,345
     
34,901
 
Accumulated other comprehensive loss on available-for-sale securities
   
(1,273
)
   
(350
)
Accumulated deficit
   
(29,605
)
   
(24,134
)
Total stockholders’ equity
   
4,467
     
10,417
 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
 
$
7,425
   
$
12,731
 
 


Investor Contact:
EVC Group, Inc.
Michael Polyviou/Amanda Prior
646-445-4800
mpolyviou@evcgroup.com/aprior@evcgroup.com
 
 

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