Adjournment of Annual Meeting
On June 10, 2022, Biocept, Inc. convened and adjourned its 2022 Annual Meeting of Stockholders (the “Annual Meeting”), without any business being conducted, due to lack of the requisite quorum being present. The Annual Meeting has been adjourned until 1:30 p.m. Pacific Time on Friday, July 8, 2022. The reconvened Annual Meeting will be held at the same virtual meeting link at www.proxydocs.com/BIOC.
Business Update
As previously announced on May 23, 2022 and discussed on our business update call on June 7, 2022, we are pursuing a re-focused business strategy. Our objective is to lead the emerging category of neurological tumor diagnostics with our CNSide™ cerebrospinal fluid (“CSF”) assay and become the provider of choice for biopharmaceutical companies developing therapies to treat cancer that has metastasized to the central nervous system. We estimate the initial annual market opportunity for CNSide to be $1.2 billion in the United States and $2.0 billion globally. Over time, we plan to explore the uses of CNSide for additional indications that could further expand the market opportunity, including, eventually, potentially other diseases beyond cancer that affect the central nervous system. In order to focus our resources on opportunities involving CSF, we plan to exit our blood-based oncology diagnostics business. This initiative is about 60% complete, and we expect it to be fully completed by the end of the third quarter of this year. We also plan to support our community with RT-PCR COVID-19 testing for as long as there is need and we can do so profitably.
We intend to generate evidence of clinical utility that will support CNSide reimbursement and adoption into patient care guidelines through our own and investigator-initiated clinical trials, while forming collaborations with biopharmaceutical companies that are developing treatments for central nervous system tumors or looking to expand indications of use for existing targeted therapies.
Preparations are underway for our company-sponsored FORESEE clinical trial, with enrollment expected to begin in the third quarter of this year. The FORESEE trial is expected to be a two-part multicenter prospective clinical trial that enrolls patients with breast cancer or non-small cell lung cancer who have suspected or confirmed leptomeningeal metastases. The trial is designed to compare CNSide with CSF cytology and radiology. The goal of the FORESEE trial is to further evaluate the performance of CNSide in monitoring response to treatment in a prospective clinical trial setting and to assess the impact of CNSide on treatment decisions made by physicians. This trial design is focused on demonstrating clinical utility, which is based on how and to what extent physicians find value in the detection of disease and how CNSide influences them in their decision-making. As we initiate and progress our planned FORESEE trial, we anticipate that some of the CNSide tests that would otherwise have been purchased commercially will be ordered for patients participating in the FORESEE trial, which would reduce commercial volume.
We also intend to solicit and fund select investigator-initiated trials, with the first such trial expected to begin before the end of 2022. These studies would target specific indications for use of CNSide, some of which may lead to expanded market opportunities. We plan to utilize the clinical evidence from these trials to create peer-reviewed publications demonstrating the valuable role CNSide can play in the care of patients with metastatic central nervous system cancers. We expect to submit the first peer-reviewed paper this year, with publication expected in the first quarter of 2023.
We also intend to seek to identify additional technologies, products and services we can in-license or acquire that can augment our offerings to neuro-oncologists.
