PRISM Q&A CORNER
Josh Riggs, CEO, OncocyteOncocyte: Disrupting the Precision Diagnostics Marketplace with Innovative Approach to Growth
Precision diagnostics company, Oncocyte Corporation (Nasdaq: OCX) (“Oncocyte” or the “Company”) is working to disrupt the mature diagnostics marketplace with a nimble, capital-light approach to growth. The Company has adopted a partnering approach to take its products to market, a model that is designed to be scalable worldwide.
Oncocyte has designed, developed and is working to commercialize precision tests in the transplant and oncology markets. The Company’s transplant diagnostic tests, VitaGraft™ and GraftAssureTM, measure the health of a transplanted organ via a simple blood test, and its oncology tests, DetermaIO™ and DetermaCNI™, measure individual patients’ suitability for and response to immunotherapy.
This month, Oncocyte completed a successful $15.8 million private placement, which reinforced the strong support the Company has from its core investors and interest from new investors.
The Company achieved some critical milestones in 2023, including securing reimbursement for its VitaGraft Kidney product and establishing an important commercialization partnership with Bio-Rad, a global leader in the life science research and clinical diagnostic markets, which included a $3.5 million upfront investment.
PRISM MarketView spoke to Oncocyte’s CEO, Josh Riggs, about how the Company plans to continue building value for investors in 2024.
A:Oncocyte is expecting a number of significant catalysts during 2024. We are currently supporting the recent commercial launch of VitaGraft™ Kidney, following achieving reimbursement for VitaGraft™ Kidney in 2023. We are also very excited to begin working with Bio-Rad on the commercialization of our GraftAssure™ assay product for research use only (RUO), which is expected to launch in Q2 2024 to a select group of academic transplant centers in the US and the EU, and more broadly in the second half of the year. Having the support of the Bio-Rad team in the US and Germany will provide us with the scale we need to meet the market opportunity. We are also working with Bio-Rad on the development of our VitaGraft Kidney in vitro diagnostics (IVD) product. As part of our agreement, Bio-Rad has been granted an option to secure the commercial rights to VitaGraft IVD subject to certain conditions, which would come with a second equity investment into Oncocyte. If everything goes well, we expect FDA clearance for the IVD product in the fourth quarter of 2025.
We believe that Oncocyte is well-positioned to meet a number of critical commercial and regulatory milestones during the year and into 2025.
A:Building out commercial teams can be incredibly expensive, and it doesn’t always return shareholder value. Our strategy involves entering partnerships with leading providers that have established commercial channels, as we work to commercialize our distributable kitted product. It is a high-margin, low-complexity business model that we believe is scalable and that we expect to lead to substantially higher returns, since our products carry a high gross margin. We have employed this capital-light model, starting with our partnership with Bio-Rad, to enable us to deliver long term value for shareholders.
Q:A:Going into 2024, our operation is leaner and positioned to deliver the best value for investors. We are proud to have achieved a reduction in operating expenses of approximately 50%, and we have no debt. In 2023, we divested DetermaRx, allowing us to reduce and refine our product offering, and freeing up capital to pursue activity that will allow us to deliver on our growth strategy. Following our successful capital raise of $15.8 million in gross proceeds received from existing and new investors, Oncocyte has a cash runway sufficient to fund early commercialization and critical steps in the creation of regulated products.
A:We are addressing two key markets: transplant diagnostics and oncology diagnostics. We believe that our simplified, fast and precise tests have the potential to significantly disrupt these markets, providing benefits to patients, clinicians and insurers. The transplant diagnostics market is currently valued at $4 billion globally and $2 billion in the US, and our competitors are generating an estimated $500 million each year in revenue.
Immunotherapy holds promise as a treatment for cancer for some patients, but can come with significant risks. Our oncology tests help physicians assess whether a patient will benefit from immunotherapy (DetermaIO), and once treatment is established, whether a patient is responding (DetermaCNI). These diagnostics markets are valued at $2 billion and $4 billion respectively in the United States alone. The application of immunotherapy is a global problem, so we expect partnering opportunities for each of our products as they reach clinical maturity.
Q:A:Prior to dd-cfDNA monitoring, biopsy was used to monitor transplanted organs for signs of rejection. Biopsies are costly, invasive and painful, and increase a patient’s risk of being hospitalized due to complications. Oncocyte’s diagnostic test offers a comparable alternative via a simple blood draw with fast turnaround time. We believe that our technology has the potential to improve transplant management. Oncocyte is initially targeting the liver and kidney transplant markets, and we have established an active early-access program for our tests at our lab in Nashville TN.
A:We want to ensure that clinicians and researchers will return to Oncocytes products again and again, so our diagnostic products have been designed with economics and ease of use in mind. Our tests are built on a polymerase chain reaction (PCR) platform, which offers a streamlined workflow process that is uncomplicated, inexpensive and fast, with results typically generated within four to eight hours. The majority of diagnostic tests on the market today are based on a next generation sequencing (NGS) platform. NGS diagnostics have historically offered a number of benefits, but also present technical challenges, including higher complexity and challenging sample economics in lower volume settings.
About Oncocyte
Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a clinical blood-based solid organ transplantation monitoring test, GraftAssure™ is a research use only blood-based solid organ transplantation monitoring test, DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and the pipeline test DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information, visit https://oncocyte.com/
VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation.
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,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, expectations regarding the successful commercialization of GraftAssure RUO and development of VitaGraft Kidney IVD, the belief that the Company is well positioned to meet a number of critical commercial and regulatory milestones, the Company’s cash runway and 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 diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests. Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Precision diagnostics company, Oncocyte Corporation (Nasdaq: OCX) (“Oncocyte” or the “Company”) is working to disrupt the mature diagnostics marketplace with a nimble, capital-light approach to growth. The Company has adopted a partnering approach to take its products to market, a model that is designed to be scalable worldwide.
Oncocyte has designed, developed and is working to commercialize precision tests in the transplant and oncology markets. The Company’s transplant diagnostic tests, VitaGraft™ and GraftAssureTM, measure the health of a transplanted organ via a simple blood test, and its oncology tests, DetermaIO™ and DetermaCNI™, measure individual patients’ suitability for and response to immunotherapy.
This month, Oncocyte completed a successful $15.8 million private placement, which reinforced the strong support the Company has from its core investors and interest from new investors.
The Company achieved some critical milestones in 2023, including securing reimbursement for its VitaGraft Kidney product and establishing an important commercialization partnership with Bio-Rad, a global leader in the life science research and clinical diagnostic markets, which included a $3.5 million upfront investment.
PRISM MarketView spoke to Oncocyte’s CEO, Josh Riggs, about how the Company plans to continue building value for investors in 2024.
Oncocyte is expecting a number of significant catalysts during 2024. We are currently supporting the recent commercial launch of VitaGraft™ Kidney, following achieving reimbursement for VitaGraft™ Kidney in 2023. We are also very excited to begin working with Bio-Rad on the commercialization of our GraftAssure™ assay product for research use only (RUO), which is expected to launch in Q2 2024 to a select group of academic transplant centers in the US and the EU, and more broadly in the second half of the year. Having the support of the Bio-Rad team in the US and Germany will provide us with the scale we need to meet the market opportunity. We are also working with Bio-Rad on the development of our VitaGraft Kidney in vitro diagnostics (IVD) product. As part of our agreement, Bio-Rad has been granted an option to secure the commercial rights to VitaGraft IVD subject to certain conditions, which would come with a second equity investment into Oncocyte. If everything goes well, we expect FDA clearance for the IVD product in the fourth quarter of 2025.
We believe that Oncocyte is well-positioned to meet a number of critical commercial and regulatory milestones during the year and into 2025.
Building out commercial teams can be incredibly expensive, and it doesn’t always return shareholder value. Our strategy involves entering partnerships with leading providers that have established commercial channels, as we work to commercialize our distributable kitted product. It is a high-margin, low-complexity business model that we believe is scalable and that we expect to lead to substantially higher returns, since our products carry a high gross margin. We have employed this capital-light model, starting with our partnership with Bio-Rad, to enable us to deliver long term value for shareholders.
Going into 2024, our operation is leaner and positioned to deliver the best value for investors. We are proud to have achieved a reduction in operating expenses of approximately 50%, and we have no debt. In 2023, we divested DetermaRx, allowing us to reduce and refine our product offering, and freeing up capital to pursue activity that will allow us to deliver on our growth strategy. Following our successful capital raise of $15.8 million in gross proceeds received from existing and new investors, Oncocyte has a cash runway sufficient to fund early commercialization and critical steps in the creation of regulated products.
We are addressing two key markets: transplant diagnostics and oncology diagnostics. We believe that our simplified, fast and precise tests have the potential to significantly disrupt these markets, providing benefits to patients, clinicians and insurers. The transplant diagnostics market is currently valued at $4 billion globally and $2 billion in the US, and our competitors are generating an estimated $500 million each year in revenue.
Immunotherapy holds promise as a treatment for cancer for some patients, but can come with significant risks. Our oncology tests help physicians assess whether a patient will benefit from immunotherapy (DetermaIO), and once treatment is established, whether a patient is responding (DetermaCNI). These diagnostics markets are valued at $2 billion and $4 billion respectively in the United States alone. The application of immunotherapy is a global problem, so we expect partnering opportunities for each of our products as they reach clinical maturity.
Prior to dd-cfDNA monitoring, biopsy was used to monitor transplanted organs for signs of rejection. Biopsies are costly, invasive and painful, and increase a patient’s risk of being hospitalized due to complications. Oncocyte’s diagnostic test offers a comparable alternative via a simple blood draw with fast turnaround time. We believe that our technology has the potential to improve transplant management. Oncocyte is initially targeting the liver and kidney transplant markets, and we have established an active early-access program for our tests at our lab in Nashville TN.
We want to ensure that clinicians and researchers will return to Oncocytes products again and again, so our diagnostic products have been designed with economics and ease of use in mind. Our tests are built on a polymerase chain reaction (PCR) platform, which offers a streamlined workflow process that is uncomplicated, inexpensive and fast, with results typically generated within four to eight hours. The majority of diagnostic tests on the market today are based on a next generation sequencing (NGS) platform. NGS diagnostics have historically offered a number of benefits, but also present technical challenges, including higher complexity and challenging sample economics in lower volume settings.
About Oncocyte
Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a clinical blood-based solid organ transplantation monitoring test, GraftAssure™ is a research use only blood-based solid organ transplantation monitoring test, DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and the pipeline test DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information, visit https://oncocyte.com/
VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation.
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,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, expectations regarding the successful commercialization of GraftAssure RUO and development of VitaGraft Kidney IVD, the belief that the Company is well positioned to meet a number of critical commercial and regulatory milestones, the Company’s cash runway and 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 diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests. Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
