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Oncocyte Corporation
4/3/2023
Today's call is being recorded. At this time, I'd like to turn the call over to Caroline Corner, Westwick Invest Relations. Please go ahead.
Thank you, everyone, for joining us for today's conference call to discuss OncaSight's fourth quarter and year-end 2022 financial results and recent operating highlights. If you've not seen today's financial results press releases, please visit the investors page on the company's website. Before turning the call over to Joshua Riggs, ONCA Sites President and Chief Executive Officer, I would like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. Any statements that are not historical facts are forward-looking statements. We encourage you to review the company's SEC filings, including, without limitations, the company's forms 10-K and 10-Qs, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. These factors may include, without limitation, risks inherent in the development and or commercialization of potential diagnostic tests, uncertainty in the results of clinical trials or regulatory approvals, the need to obtain third-party reimbursement for patient use of any diagnostic tests the company commercializes, our need and ability to obtain future capital and maintenance of IP rights, risks inherent in strategic transactions such as failure to realize anticipated benefits, legal, regulatory, or political changes in the applicable jurisdictions, accounting and quality controls, greater than estimated allocations of resources developed in commercialized technologies, or failure to maintain any laboratory accreditation or certification, and uncertainties associated with COVID-19 pandemic and its possible effects on our operations. Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. ONCA site expressly disclaims any intent or obligation to update these forward-looking statements, except as otherwise may be required under applicable law. I'll now turn the call over to Josh Riggs. Josh?
Hello. Thanks, Caroline, and welcome everyone to our conference call to discuss our fourth quarter 2022 and year-end financial results and operating highlights. Joining me today is Anish John, our Chief Financial Officer. Following our prepared remarks, as always, we'll be happy to take your questions. I would like to start the call by expressing my gratitude to the Oncocyte team, our investors, board, and those in the clinical community who continue to support us in our mission in serving patients and groundbreaking science. On March 2nd, we announced my appointment as President and CEO, as well as a Director of Oncocyte. I am honored to serve the team as we go into the next phase of development and commercialization. We are positioning the company for success in a challenging market environment by focusing on our core products and operational and commercial efficiency. On December 16th, we announced our entry into a stock purchase agreement to transfer 70% of our ownership of Razor Genomics and all of the assets and liabilities related to Determa Rx. This transaction, which closed in February 2023, eliminated an estimated $8 million of annual operating expense and $13 million of future milestone and development liabilities, while allowing Razor Genomics to maintain continuity of service for DETERMA-RX patients and clinicians. At the same time, we announced a significant reduction in headcount, further reducing our operating expenses. we announced the pricing of a stock offering of up to $13.86 million from our long-term investors. Led by Broadwood partners and with significant participation from our chairman and other of our top five holders, this vote of confidence comes at a critical time for OncoSight. In a challenging macro market environment, this deal was completed at market with no warrant coverage and allows us to retire a significant portion of our preferreds. DETERMA-IO, DETERMA-CNI, and Vitagraph represent the future of Oncocytes product offering. Each have multi-billion dollar market opportunities and differentiation from competitive products along with a growing body of literature and demand in the research market. DETERMA-IO and Vitagraph are being developed commercially through our early access program to drive market development and initial utilization. Development of these products will be continued throughout 2023 with the term of CNI development to follow in 2024. To be clear, all other development projects have been paused or canceled. Today, Oncocyte has been primarily focused on a service lab model to deliver clinical and shareholder value. Going forward, we are going to open up access to our breakthrough technology in distributed research use only, or RUO, product format. This provides a scalable, high-margin commercial channel for us, whether it be on our own, through commercial partners, or distribution relationships. Our service lab in Nashville will continue to engage the clinical community, pursue reimbursement, and support care decisions, while our RUO product will enable researchers around the world to innovate, publish, and explore new questions. The Terma IO continues to build its case as the best-in-class tool for assessing the tumor microenvironment as it relates to immune therapy use and optimization. As an update, data in colon cancer has been accepted for publication and will join previous data from non-small cell lung cancer and triple negative breast cancer, among others. Research in oncology is pushing us towards a real choice in first-line therapy, something beyond just anti-PD-L1 and or chemo. Researchers working in this space need a better tool to assess the state of the tumor microenvironment. that an RUO product version of the technology behind DERMA-IO can meet. Leveraging our continuous variable reporting, researchers can determine the appropriate cutoff value for their application. Key 2023 milestones will be coverage for our LDT, the completion of a SWOG study in triple negative breast cancer, and completed feasibility for our RUO product. Vitagraph, our transplant product, as best-in-class turnaround time and ease of use, leveraging the natural advantages of digital PCR over an NGS workflow. We continue to have active dialogue with Moldex to support a coverage decision for both kidney and liver. Engaging with the transplant community as a partner has shown us that there are many questions left unanswered by the service labs delivering DDCF DNA testing today, ours included. Developing and delivering an RUO version of our product opens the door to researchers at pharma, academic centers, and biotech to use donor-derived cell-free DNA to answer many unsolved problems like long-term patient management and the value of absolute quantification. We are pleased to announce today that we have completed feasibility and are in the pre-manufacturing optimization phase for our RUO product. Key 2023 milestones will be coverage for our LDT, strategic or distribution partner announced, and RUO product launch. We believe that this approach focusing on scalable, high margin products and rapid development reduces our time to market and revenue growth. We expect that our differentiated IP will drive commercial opportunities while reduced costs and a shorter path to revenue will benefit OncoSite shareholders. Vitagraph, DetermaIO, and DetermaCNI all have significant upside and our RUO strategy will allow us to scale quickly while maintaining high product margins that positively impact the company's bottom line and put us on a path to financial sustainability. We are grateful for your continued support, and I would like to now turn the call over to Anish John to review our financials. Anish?
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