KEY CATALYST ALERT: Oncocyte’s Positive VitaGraft Kidney Study Results Published in New England Journal of Medicine

HIDDEN VALUE STOCK TO WATCH: NASDAQ: OCX

Oncocyte’s Major Advancements in Precision Diagnostics

Significant Findings Highlight Use-Case for Potential Global Adoption of Test

Oncocyte Corporation (Nasdaq: OCX), a leader in precision diagnostics, has announced that their lead product, VitaGraft™ Kidney, was featured in the prestigious “The New England Journal of Medicine.” The study shows highly promising results for VitaGraft Kidney in monitoring kidney transplant health.

The research focused on VitaGraft Kidney’s effectiveness in detecting problems in transplanted kidneys. It involved a new drug called felzartamab, which targets a major cause of kidney transplant failure known as antibody-mediated rejection (AMR), which occurs when the body’s immune system attacks the transplanted kidney, leading to failure.

The study’s positive results highlight the potential of VitaGraft Kidney to improve the monitoring and management of kidney transplants, offering hope for better patient outcomes.

Quote from CEO Josh Riggs:

“We congratulate the research teams on this groundbreaking study and its potential to lead to a treatment option for kidney transplant patients suffering from AMR around the world. Our recent partnership with Bio-Rad enhances our ability to support the global transplant research community with easy-to-use monitoring tools. This study underscores new opportunities for Oncocyte’s technology to serve the clinical market and improve patient outcomes and our capital-efficient business model supports Oncocyte’s ability to penetrate the market effectively, ensuring sustained growth and profitability.”

The publication of VitaGraft Kidney study results in “The New England Journal of Medicine” marks a crucial milestone for Oncocyte’s market expansion potential. Demonstrating the efficacy of VitaGraft Kidney in monitoring kidney transplant health in patients with antibody-mediated rejection positions Oncocyte to capture a significant share of the $2+ billion transplant diagnostics markets. This breakthrough further bolsters Oncocyte’s credibility and visibility within the medical community, fostering broader adoption of the company’s innovative diagnostic solutions.

Key Study Findings

VitaGraft Kidney measures donor-derived cell-free DNA in transplant patients’ blood, a crucial biomarker for assessing graft health. The study identified responders and non-responders to felzartamab therapy, which noted s significant decreases in donor-derived cell-free DNA fractions at weeks 12 and 24, indicating the test’s efficacy in monitoring therapeutic response and detecting disease recurrence.

“The New England Journal of Medicine (NEJM):” The Pinnacle of Medical Journals with Unmatched Credibility and Impact

“The New England Journal of Medicine (NEJM)” is often regarded as the pinnacle of medical journals. Published for over 200 years, it sets the gold standard in the medical field, offering peer-reviewed research and clinical content that is highly respected and widely cited globally. Known for its rigorous editorial and peer-review processes, only 5% of original research submissions achieve publication, ensuring the highest quality and scientific accuracy. NEJM boasts an outstanding 2022 Journal Impact Factor of 158.5, making it the top-ranking medical journal in the general medicine category. Publication in NEJM is a strong validation of a company’s medical research and innovations, reflecting the utmost credibility and significance in the scientific community.

Clinical Implications and Future Applications

The results suggest new clinical uses for VitaGraft Kidney beyond its current indication for cause testing. Potential applications include monitoring how well a treatment is working and detecting the recurrence of antibody-mediated rejection. These applications would require multiple tests during active management and long-term follow-up. The study highlighted the test’s potential to guide dosing intervals and the duration of anti-rejection therapy.

Addressing a Critical Unmet Need

Antibody-mediated rejection affects up to 20.2% of kidney transplant patients within 10 years, with a high progression rate to graft failure. The combination of felzartamab and VitaGraft Kidney testing may address this unmet need by enabling early detection and effective management of AMR. Oncocyte’s technology has demonstrated the capability to detect AMR up to 10 months earlier than current protocols, presenting a significant advancement in transplant care.

With the continuous development and commercialization of advanced diagnostic tests, Oncocyte is poised to seize substantial market opportunities and revolutionize patient care. These advancements in diagnostic precision and early disease detection will drive demand, positioning Oncocyte as a leader in precision diagnostics and significantly impacting the healthcare industry.

Blockbuster Partnership with Life Science Leader Accelerates Go-to-Market Strategy

Oncocyte’s partnership with Bio-Rad (NYSE:BIO), a global leader in the life science research and clinical diagnostic markets, established in April 2024, included a $3.5 million upfront investment with potential further investments following regulatory approvals. This collaboration underscores the strategic commercialization paths Oncocyte pursues, leveraging established channels to enhance market reach and product accessibility.

Addressable Target Market Size: Catalyzing Growth in High-Value Markets

Antibody-Mediated Rejection (AMR) Detection Market:
 Up to 25% of kidney transplant patients will develop de-novo DSA within the first five years post transplant.¹ Many of these patients will progress to AMR and lose their grafted organ. Oncocyte was the first company to show randomized interventional data picking up AMR 10+ months ahead of protocol. The study called for 6 tests in the first year from DSA+ creating a significant revenue opportunity should the claim be approved by MolDX, its CMS payor. Oncocyte’s entry into this market represents a significant opportunity to redefine precision diagnostics and transform patient care on a global scale.

Transplant Diagnostics:
 VitaGraft addresses a global market where competitors currently generate hundreds of millions in revenue annually. With the U.S. market valued at approximately $2 billion and a worldwide potential of $4 billion, VitaGraft is poised to capture significant market share. It offers a non-invasive, highly effective alternative to traditional biopsy methods, appealing to a growing demand for less invasive and more accurate diagnostic solutions.

Oncology Diagnostics:
 DetermaIO and DetermaCNI focus on the oncology sector, where precision diagnostics are increasingly vital. DetermaIO taps into a market where competing tests currently generate about $1.5 billion in revenue, with potential growth to $2 billion in the U.S. and $4 billion globally. DetermaCNI, designed to detect cancer progression at its earliest stages, enters a market with vast growth potential estimated at $4 billion in the U.S. and $8 billion worldwide.

ONCOCYTE (NASDAQ: OCX) IS A MEDTECH MOVER WITH A MISSION

Securing Regulatory and Reimbursement Success

Oncocyte is proactive in securing favorable regulatory outcomes and strong reimbursement setups to minimize commercial risks. With several products already having secured reimbursement and others in the pipeline awaiting approval, Oncocyte is well-positioned for successful market introductions and sustained growth.

Join Our Informative Event on VitaGraft Kidney Study Results

Oncocyte will host a conference call to discuss the exciting results of our VitaGraft Kidney study. Dr. Klemens Budde, Head of Transplantation at Charite, and Dr. Ekke Schuetz, Chief Science Officer at Oncocyte, will lead the discussion. Josh Riggs, CEO of Oncocyte, will provide an operational update. The call will also include a Q&A session about the upcoming launches of VitaGraft Kidney and GraftAssure.

The date and time will be announced soon. Don’t miss this opportunity to learn more about our groundbreaking work—sign up now to attend this informative event!

Sign up to attend the OCX Business Update and Q&A Event 

TOP 5 REASONS TO HAVE OCX ON YOUR WATCHLIST

Tapping into a $10 Billion Market: Oncocyte is carving out a niche in the high-value oncology and transplant diagnostics markets, which together represent over $10 billion in potential. With its innovative diagnostic solutions, such as DetermaIO, DetermaCNI, VitaGraft Kidney and VitaGraft Liver, Oncocyte is poised to transform patient care and capitalize on these substantial market opportunities.

Capital-Light Business Model: Oncocyte adopts a capital-light commercial strategy, aiming for a cost-effective path to market that enhances profitability and shareholder value. This approach allows Oncocyte to stay agile and responsive to market dynamics, providing a competitive edge in the rapidly evolving MedTech landscape.

Strategic Partnerships: Oncocyte’s collaboration with Bio-Rad, including a $3.5 million upfront investment and potential further investments, underscores the strength and potential of its diagnostic products. These partnerships not only validate Oncocyte’s market strategy but also bolster its commercial capabilities and reach.

Regulatory and Reimbursement Advantages: With several products already receiving reimbursement and others in the pipeline, Oncocyte has effectively navigated the regulatory environment to minimize commercial risk and secure a sustainable growth trajectory. This strategic foresight in regulatory affairs significantly de-risks its business model for investors.

Clinical Expansion: Oncocyte is scaling its operations and moving into clinical treatments, which broadens its impact from diagnostics into direct therapeutic applications. This expansion into clinical care solutions allows Oncocyte to offer comprehensive care packages, enhancing patient management and potentially improving long-term health outcomes, positioning the company as a holistic provider in the healthcare sector.

Innovative Product Suite

Oncocyte’s diagnostic products offer significant advantages in ease of use and speed over existing tests, such as:

• DetermaIO: A test that provides a detailed analysis of the Tumor Immune Microenvironment (TIME) to identify patients likely to benefit from immunotherapy.
• DetermaCNI: A diagnostic that detects early signs of cancer progression following the initiation of treatment.
• VitaGraft Kidney and VitaGraft Liver: These tests monitor the health of kidney and liver transplants by measuring the concentration of donor-derived cell-free DNA, offering a non-invasive alternative to painful and slow biopsies.
• GraftAssure: Utilized to assess organ health and rejection risk through donor-derived cell-free DNA, GraftAssure is being commercialized in partnership with Bio-Rad.

ANTICIPATED MILESTONES:

Preparing to ship GraftAssure™ RUO transplant monitoring test kits to Asia, the U.S. and the EU in the second quarter of 2024.

Developing VitaGraft™ Kidney IVD for FDA submission, setting the stage for broader clinical adoption and regulatory milestones throughout 2024 and into 2025.

Advancing the development of oncology diagnostics pipeline products, DetermaIO and DetermaCNI, with an eye on expanding market opportunities and enhancing patient outcomes.

Multiple publications coming out to support reimbursement decisions across all three product lines, particularly looking for the DSA+ final release in transplant, but also the 800+ triple negative breast cancer study for DetermaIO.

Site activation numbers showing uptake of the GraftAssure RUO builds a solid base to support rapid uptake at launch with high-margin and significant recurring revenue per site.

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, the anticipated launch of the Company’s GraftAssure RUO transplant rejection diagnostic test with shipments of test kits in global markets in the second quarter of 2024, the Company’s growth over the next 12 to 18 months, the expectation that the Company will successfully develop regulated products like VitaGraft Kidney IVD, the anticipation of enhanced clinical adoption and broader commercial expansion, the Company’s high-margin and low-complexity business model, expected progress toward regulatory milestones throughout 2024 and into 2025, 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.

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