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News Article | February 21, 2017
Site: globenewswire.com

ALAMEDA, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive tests for the early detection of cancer, today announced the receipt of $2,031,250 through the early exercise of 625,000 common stock purchase warrants.  Each warrant was exercised to purchase one share of common stock for $3.25 per share. The warrants were issued during August 2016 through a private placement of 3,246,153 units, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock.  The exercise transactions were negotiated with certain warrant holders as a means of raising additional near term working capital. In consideration for the early exercise of the warrants, one warrant holder received one new warrant with an exercise price of $3.25 for every two warrants exercised, while the other warrant holders received one new warrant with an exercise price of $5.50 for each warrant exercised. Following the exercise of the warrants, there are 29,361,616 shares of common stock outstanding and an aggregate of 3,033,653 warrants outstanding, including both warrants issued during August 2016 and the new warrants, with exercise prices ranging from $3.25 to $5.50. The proceeds from the early warrant exercise will be used for general working capital purposes to strengthen OncoCyte’s balance sheet, which reflected cash on hand of approximately $10.2 million as of December 31, 2016. “The early exercise of warrants by some of our largest shareholders provides a strong vote of confidence in OncoCyte and our progress towards the development of our innovative, non-invasive tests for the early detection of cancer. The capital provided to us increases our resources as we prepare for CLIA certification of our laboratory and the hiring of our launch team,” said William Annett, President & CEO.  “The warrant exercise and commensurate purchase of shares results in BioTime, Inc.’s ownership of our company falling below 50%. This is an important step in OncoCyte’s evolution into an independent company.” OncoCyte has completed sample collection for the 300-patient study of its lung cancer diagnostic test and now has all of the benign and malignant samples necessary to complete the study. Processing of the samples has been completed and an analysis of the results is underway.  The Company expects to complete the study and announce the results in March. As the analysis of the samples is carried out, OncoCyte is continuing to work on completing the steps necessary to obtain CLIA certification of a diagnostic laboratory. OncoCyte plans to apply for CLIA certification of the lab subsequent to the completion of its current lung cancer test study. After CLIA certification of the laboratory, OncoCyte will conduct a clinical validation study of its lung cancer diagnostic test using the finalized processing algorithm and operational procedures on a new set of a minimum of 300 blinded patient blood samples. “Completion of sample collection, processing the samples and analyzing the results are three key elements in developing our lung cancer diagnostics test,” said Mr. Annett. “If the results of the 300 sample study are favorable, our next steps will be to begin the final clinical validation study and finalize our commercialization plans.” The development of the test builds on research that began a decade ago at the Wistar Institute and has proceeded at OncoCyte and in collaboration with several key opinion leaders in the field of lung cancer diagnosis. OncoCyte recently announced that its abstract on interim data from its current lung cancer diagnostic test study has been selected for presentation in a poster discussion session at the 2017 American Thoracic Society (ATS) International Conference in Washington, D.C.  The discussion will be led by Dr. Anil Vachani, an Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Veteran's Administration Medical Center.  The analysis “Multi-Gene Classifier for the Diagnosis of Benign Versus Malignant Pulmonary Nodules” will be discussed in the “Pulmonary Nodules and Thoracic Surgery: Working Across the Aisle” session to take place at 2:15 p.m. on Monday, May 22nd. OncoCyte is 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 lung, bladder and breast cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein biomarkers that are differentially expressed in specific types of cancer. For more information visit www.oncocyte.com. This press release contains 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, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. 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, 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 “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.


News Article | February 27, 2017
Site: globenewswire.com

Enters into New Credit Facility with Silicon Valley Bank Conference Call Scheduled for Monday, March 6, 2017 at 4:30 PM ET ALAMEDA, Calif., Feb. 27, 2017 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive, ”liquid biopsy” tests to aid in the early detection of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2016. OncoCyte also reported that it has entered into a secured loan agreement with Silicon Valley Bank providing access to $2.0 million of additional working capital. “The extension of credit by a well-established institution such as Silicon Valley Bank is the latest example of the progress we are making at OncoCyte,” said William Annett, President and Chief Executive Officer.  “We achieved several significant milestones during 2016 as we demonstrated the robustness of our product development pipeline through the presentation of positive test data for the lung, breast and bladder cancer diagnostics we are developing. The processing of blood samples from our 300-patient study for our lung cancer diagnostic has been completed, and we are waiting to receive the analysis, which we expect will occur during March. “Should our analysis support the clinical effectiveness of our lung cancer test, we will swiftly take the next steps necessary to complete the development process and launch the test during the second half of 2017, so that we can begin to address the significant market opportunity we believe exists for a non-invasive test for the early detection of lung cancer,” Mr. Annett continued.  “We know from clinician discussions and market research that there is a large U.S. opportunity for a product that can help clinicians manage suspicious lung nodules.  As more high risk patients are screened for lung cancer, the number of suspicious nodules being referred to follow-up procedures is expected to grow to 1.4 million patients, which will add significantly to the healthcare burden and put more patients at risk. OncoCyte incurred a net loss of $3.1 million, or $0.11 per share, during the quarter ended December 31, 2016, compared to a net loss of $3.5 million, or $0.14 per share, during the fourth quarter of 2015. For the full year, the net loss was $11.2 million, or $0.42 per share, compared to a net loss of $8.7 million, or $0.42 per share for 2015. Research and development expenses of $1.4 million for the quarter were unchanged from the same period of 2015.  For the year, research and development expenses increased to $5.7 million from $4.5 million the prior year. Overall the increase in research and development expenses is due to increased staffing and costs of clinical trials as part of the development of the Company’s lung cancer diagnostic test. General and administrative expenses for the quarter ended December 31, 2016 decreased to $1.7 million from $2.1 million for the same period in 2015. For the full year, general and administrative expenses were $5.5 million as compared to $4.2 million for 2015.  The quarter over quarter decrease was mainly attributable to lower stock-based compensation expense.  The year over year increase is attributable to increased staffing, including both management and consulting personnel. At December 31, 2016, OncoCyte had $10.2 million of cash and cash equivalents in addition to available-for-sale securities valued at $2.2 million.  Subsequent to the end of the year, OncoCyte received proceeds of $2.0 million for the early exercise of warrants.  As a result of the warrant exercise, OncoCyte had 29,361,616 shares of common stock outstanding on February 17, 2017. The dial-in number in the U.S./Canada is 888-427-9421, for international participants the number is 719-325-2450. For all callers, refer to Conference ID 9994065. To access the live webcast, go to the investor relations section on the company’s website, 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 888-203-1112-toll-free (from U.S./Canada); international callers dial +1 719-457-0820. Use the Conference ID 9994065. Additionally, the archived webcast will be available http://investors.oncocyte.com/events-and-presentations. The United States Preventative Services Taskforce (USPSTF) has recommended annual lung cancer screening for high risk lung cancer patients.  High risk is defined by a long term history of heavy smoking and is defined in pack years.   The USPSTF guidelines recommend low-dose CT (LDCT) screening for patients 55 to 85 with a 30-pack year history (smoking a pack of cigarettes a day for 30 years, or multiples thereof).  Health economists have estimated that between 8 to 10 million Americans will qualify for annual lung cancer screening.   The National Lung Screening Trial has estimated that 9% of these patients will be found to have suspicious nodules needing follow-up.  In addition to higher risk patients, health economists have estimated that approximately 5 million patients a year present with nodules through incidental imaging.  This includes x-rays, MRIs, CTs that are done for patients with other chest symptoms or injury diagnoses. This totals to 13 million to 15 million Americans who have or are at risk for lung nodules. Of these it is estimated that approximately 1.4 million per year may have lung nodules 5 mm or larger, the size range for intended use of OncoCyte’s lung cancer diagnostic test. OncoCyte is 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 lung, bladder and breast cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein biomarkers that are differentially expressed in specific types of cancer. For more information visit www.oncocyte.com. This press release contains 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, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. 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, 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 “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.


ALAMEDA, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, announced today that William Annett, Chief Executive Officer, is scheduled to present an overview of the company and its progress at the Cowen and Company 37th Annual Health Care Conference in Boston, MA. The presentation will begin at 9:20 a.m. ET on Wednesday, March 8th, 2017 at the Boston Marriott Copley Place. Please note the attendance at the conference is by invitation only.  Investors interested in scheduling a one-on-one meeting with OncoCyte’s management during the conference should contact their Cowen representative. A live audio and/or webcast and subsequent archived replay of OncoCyte’s presentations may be accessed via the Investors section of the Company’s website under “Events & Presentations” at http://investors.oncocyte.com/. The replay will be available for 90 days after the event. OncoCyte is 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 lung, bladder and breast cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein biomarkers that are differentially expressed in specific types of cancer. For more information visit www.oncocyte.com.


The invention provides methods, compositions and kits for the detection and treatment of bladder cancer.


Embodiments of the disclosure are directed to methods of diagnosis, prognosis and treatment of cancer. The methods are particularly suited for bladder cancer. The methods include targeting a marker that is expressed at abnormal levels in bladder cancer tissue in comparison to normal somatic tissue. Also disclosed are methods of treating cancer comprising administering a composition including a therapeutic that affects the expression or function of a target marker.


Patent
Oncocyte Corporation | Date: 2012-08-16

The invention provides for methods of diagnosis, prognosis and treatment of cancer including, but not limited to, breast cancer.


The invention provides methods, compositions and kits for the detection and treatment of pancreatic cancer.


Patent
Oncocyte Corporation | Date: 2013-05-06

The invention provides methods, compositions and kits relating to the diagnosis, prognosis and treatment of breast cancer.


The invention provides methods, compositions and kits for the detection and treatment of thyroid cancer.


Patent
Oncocyte Corporation | Date: 2012-06-23

Embodiments of the disclosure are directed to methods of diagnosis, prognosis and treatment of cancer. In some embodiments, the methods include targeting a marker that is expressed at abnormal levels in bladder cancer tissue in comparison to normal somatic tissue. Some embodiments are directed to methods of treating cancer comprising administering a composition including a therapeutic that affects the expression or function of a target marker. Some embodiments are directed to methods of detecting cancer comprising detecting a level of a target marker associated with the cancer,

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