Oncocyte Unveils Q1 2024 Achievements: Strategic Partnerships and Diagnostic Innovations Anticipated to Propel Growth Over Next 12 to 18 Months

Company Expanding Transplant Initiatives to Pave the Way for Global Market Penetration and Enhanced Patient Care

Oncocyte (NASDAQ:OCX), a leading precision diagnostics company, reported its financial results for the first quarter ended March 31, 2024, revealing significant strides in its commercialization efforts and strategic developments. The company announced a global commercialization partnership with Bio-Rad Laboratories and is on track to ship its GraftAssure™ transplant monitoring test kits to initial customers in key global markets. Poised for growth over the next 12 to 18 months, Oncocyte is driven by multiple milestones in its journey to expand and enhance its market presence.

Key Highlights:

  • Announced a global commercialization partnership with Bio-Rad Laboratories, enhancing market reach and product development.
  • Successfully raised $15.8 million in equity from a private placement; Bio-Rad purchased 8.99% of Oncocyte.
  • Reduced cash burn to $3.9 million, reflecting a capital-efficient business model and financial discipline.
  • Engaged in pivotal clinical trials, with the company’s technology selected to support multiple Phase 2 studies by pharmaceutical companies developing therapeutics for antibody mediated rejection, potentially unlocking new commercial applications.
  • Advancing transplant initiatives, including the development of regulated products like VitaGraft™ Kidney IVD, which has demonstrated ability to detect transplant rejection earlier than standard methods. Oncocyte anticipates this innovation will enhance clinical adoption and support broader commercial expansion.
  • Targeting the global transplant market, which sees over 157,000 transplants annually with a growth rate of 9.1%, presenting a substantial opportunity for growth and market penetration.

 

Josh-Riggs-Oncocyte

Quote from CEO Josh Riggs:

“In the first quarter of 2024, Oncocyte made significant progress toward commercializing its innovative blood-based diagnostic tests. That progress was bolstered by a $15.8 million equity private placement and a global strategic partnership with Bio-Rad Laboratories. We believe that the collaboration with Bio-Rad is pivotal for the upcoming launch of our GraftAssure RUO transplant rejection diagnostic test kit and central to our mission of developing and providing accessible point of care diagnostics and continuous innovation in transplant rejection monitoring.”

 

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.

 

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.

Company Mission:

Oncocyte (NASDAQ:OCX) is committed to democratizing diagnostic testing, ensuring that every patient, regardless of location or circumstances, has access to fast, reliable, and affordable diagnostic solutions. This mission drives the company’s focus on innovation and user-friendly technologies, aimed at leveling the playing field in healthcare and improving patient outcomes globally.

What to Watch For:

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. (1)

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

(1)Antibody-mediated rejection: prevention, monitoring and treatment dilemmas – PMC (nih.gov)

 

About Oncocyte (NASDAQ: OCX)

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 (RUO) blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information about Oncocyte, please visit https://oncocyte.com/.

 

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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Oncocyte Unveils Q1 2024 Achievements: Strategic Partnerships and Diagnostic Innovations Anticipated to Propel Growth Over Next 12 to 18 Months

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