OncoCyte Announces Agreement to Acquire Molecular Diagnostics Company

OncoCyte  Corporation recently announced it has entered into an  agreement to acquire, through a subsidiary, all of the outstanding capital stock of privately-held Insight Genetics, Inc. (IG), which has a history of impactful discoveries in the areas of lung and breast cancer.

OncoCyte entered into the agreement to access IG’s technology and pharma service offerings. IG has a rich menu of relevant targeted therapeutic panels including two emerging therapeutic targets, RET and NTRK. IG’s lead test is the Immune Modulation (IM Score), a gene expression test that measures the state of the immune system in biopsies from cancer patients to identify patients more likely to respond to PD-1/PD-L1 immunotherapies. Data presented at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting showed a strong association of the IM score with response to PD-1/PD-L1 targeted immunotherapy in lung cancer. Importantly, the IM Score test was superior to two currently marketed predictive companion diagnostic tests for immunotherapy selection, PD-1/PD-L1 IHC staining and tumor mutational burden (TMB). IG’s lab has capacity to support clinical trials or assay design across a cadre of currently available commercial platforms to develop companion diagnostics and has successfully completed audits by major pharmaceutical and diagnostic companies. IG has performed assay development and clinical testing for leading pharmaceutical and biotechnology companies.

IG has achieved ISO 9001 certification, and it has a CLIA certified and College of American Pathology accredited lab that performs and develops proprietary cancer tests. IG’s initial work identified and patented an ALK PCR translocation assay licensed by Qiagen. Its second initiative focused on Triple Negative Breast Cancer (TNBC), where IG developed a unique classifier that identifies six subtypes of TNBC, many of which have been demonstrated to have potential companion diagnostic applications to help women manage this deadly form of cancer.

“The addition of the Insight Genetics IM Score Test expands the decision points that OncoCyte’s proprietary portfolio of tests addresses along the lung cancer continuum of care. To our knowledge this test is uniquely differentiated in that it characterizes immune response in cancer tissue in the context of characteristics of surrounding tissue. Combined with DetermaRx (previously the Razor treatment stratification test), we now have proprietary tests that help manage key decision points in both early and more advanced lung cancer, ” said Dr. Doug Ross, Consulting Chief Medical Officer of OncoCyte.

The principal investigator of IG’s study, Dr. Gregory Vidal MD, PhD, Lead of the Breast Cancer Research program at the West Cancer Center and Research Institute and Assistant Professor of Hematology/Oncology at the University of Tennessee Health Science Center, added “Identifying which patients will benefit most from immunotherapy remains an outstanding question for oncologists. The data presented by the Insight Geneticsteam at SITC is incredibly promising, and the oncology community is looking forward to seeing the impact the IM score test can have on a broader patient population. I believe it has the potential to improve patient outcomes and streamline the development of new therapies.”

Padma Sundar, SVP Marketing and Market Access, also added “According to a recent JAMA publication, close to 750,000 patients are eligible for immunotherapy treatment, representing a $2.2 billion total addressable market. The eligible patient population is anticipated to increase as immunotherapies are approved for the early stage adjuvant setting. In addition, there are close to 3,000 PD-1/PD-L1 ongoing clinical trials that are expected to recruit over 500,000 patients representing a large pharma services opportunity.”

Al Parker, Chief Operating Officer of OncoCyte, further commented ”We believe the combination of assets contemplated in this transaction will create enhanced value for our stakeholders and shareholders and advances our mission to provide actionable answers at critical and underserved decision points in lung cancer.”

Upon closing, OncoCyte will deliver closing consideration of approximately $12 million, consisting of $7 million in cash and $5 million of OncoCyte common shares, less deductions for transaction expenses and other liabilities.

The merger agreement provides for OncoCyte to pay a 10-year revenue share of not more than 10% of net collected revenues for current IG pharma service offerings and a tiered revenue share percentage of net collected revenues through the end of the lifecycle if certain new cancer tests are developed using IG technology. OncoCyte may pay contingent consideration of up to $6 million, in any combination of cash or OncoCyte common shares if certain milestones are achieved.

The closing of the merger with IG is subject to a number of conditions, including approval of the merger by IG’s stockholders.  OncoCyte will issue the shares in a private placement and has agreed to register the shares for resale. Additional information regarding the terms of the transaction will be provided in OncoCyte’s Current Report on Form 8-K expected to be filed with the Securities and Exchange Commission on January 10, 2020.

Insight Genetics is dedicated to improving the lives of cancer patients through advanced molecular diagnostics that enable precision cancer care. The company specializes in the discovery, development and commercialization of molecular diagnostics that detect specific cancer biomarkers in triple negative breast cancer and lung cancer to assist in guiding the effective diagnosis, treatment and monitoring of cancer. Insight Genetics partners with leading academic researchers, pharmaceutical and biotechnology companies, clinical reference laboratories, and IVD kit manufacturers to create new standards of care for cancer patients worldwide.

OncoCyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the lung cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The company is currently preparing to launch a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. DetermaDx, the company’s liquid biopsy test in development, utilizes a proprietary immune system interrogation approach to clarify if a patients’ lung nodules are benign, which may enable them to avoid potentially risky invasive diagnostic procedures.