Additional Proxy Soliciting Materials (definitive) (defa14a)
May 03 2017 - 6:06AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
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Definitive Additional
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Soliciting Material
Pursuant to §240.14a-12
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Corporation
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OncoCyte
Corporation
1010
Atlantic Ave, Suite 102
Alameda,
CA 94501
Phone:
(510) 775-0515
Email:info@OncoCyte.com
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May
2, 2017
Dear
Shareholders,
In
the past year OncoCyte has made steady progress towards its goal of creating innovative diagnostic tests for cancer. We are excited
by our success to date, and in particular by the prospective launch of our first commercial product in the second half of this
year.
We
believe that our novel, non-invasive liquid biopsy tests will aid in the early detection of cancer and reduce the healthcare costs
and patient risks associated with unnecessary biopsies and their complications. Today the vast majority of biopsies for lung cancer
and breast cancer have benign results. Our tests are designed to be administered after screening tests, such as low dose CT scans
for lung cancer and mammograms for breast cancer, thereby eliminating unnecessary biopsies of benign tumors.
We
are proud of our achievements over the past year, during which we:
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Entered
into a definitive global licensing agreement with The Wistar Institute of Anatomy and Biology, providing OncoCyte the exclusive
right to commercialize the lung cancer diagnostic test that OncoCyte and Wistar have been collaboratively developing on since
2013.
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Completed a market
research study of 180 physicians, and a health economic outcomes study, which lead OncoCyte to believe that a successful confirmatory
lung cancer test must have a sensitivity of at least 85% and a specificity of at least 30%.
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Announced successful
results of Wistar’s lung cancer test study of 610 subjects which was presented at the CHEST 2016 Annual Meeting in October
2016. The Area Under the Curve (AUC) in Wistar’s study was 0.82 with a sensitivity of 90% and specificity of 62%. These
results are significantly above the levels that we believe are necessary for a commercially viable lung cancer test.
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Set up a network
of over 40 clinical sites across the United States to collect samples for our lung cancer studies.
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Initiated a 300
patient internal R&D Validation study for the lung cancer diagnostic test to see whether we could confirm Wistar’s
results using our equipment to analyze samples that we collected.
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Presented positive
data on our other pipeline products at prestigious medical conferences – at the San Antonio Breast Cancer Symposium
for our breast cancer test and at the American Society of Clinical Oncology for our bladder cancer test.
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Built our R&D
and commercial teams by hiring accomplished professionals with extensive experience in diagnostics.
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We
have continued to build momentum during 2017:
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Reported
the successful results of our lung cancer R&D Validation study, which were consistent with results of Wistar’s earlier
study.
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Continued to build
our team by adding to the CLIA laboratory a board certified Clinical Laboratory Director, a clinical supervisor and a licensed
technologist.
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Ramped up the marketing
and market access functions required for launch of the lung cancer diagnostic test.
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Submitted our application
for Clinical Laboratory Improvement Amendments (CLIA) certification of our laboratory, which will be used for commercial operations.
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Announced that our
breast cancer test development is ahead of schedule and commercial launch is being targeted for late 2018
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With
the successful completion of these milestones we are taking the next steps required to launch our lung cancer diagnostic test.
We believe that we will receive CLIA certification late in the second quarter, and then will proceed with Clinical Validation
studies to be carried out in the CLIA lab. If these studies are successful we will launch the lung test in the second half of
2017.
We
are very excited about the commercial potential for our lung cancer test, and estimate that there are approximately 1.4 million
patients annually in the U.S. who could benefit from it. Assuming this number of patients and our currently planned pricing, the
total addressable market could potentially exceed $4 billion. Furthermore, we believe that OncoCyte is positioned to be the first
company to enter this market with a highly accurate test, and that it will be several years before competitors reach the market.
This first mover advantage should be significant, and we hope to use it to develop deep relationships with the key stakeholders
necessary for commercial success – patients, physicians and payors. Our test should have significant benefits for each group,
improving the diagnostic process for doctors, helping patients avoid risky and unnecessary biopsies, and providing payors with
significant cost savings by reducing unnecessary procedures and complications.
With
our lung cancer diagnostic currently on schedule and our breast cancer diagnostic test development moving forward we are pleased
with OncoCyte’s progress to date. Thank you for your continued support as we work to achieve these objectives.
Respectfully,
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William Annett
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Alfred D. Kingsley
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Chief Executive Officer
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Chairman of the Board of Directors
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