• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI Executive AssistantNEW
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI Executive AssistantNEW
  • Settings
  • RSS Feeds
PublishGo to AppAI Helper
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI employees for your businessNEW
    Legal
    Terms of usePrivacy policyCookie policy

    Oncocyte Reports Successful 2024; Sets Stage for 2025 Catalysts

    3/24/25 4:05:00 PM ET
    $BIO
    $OCX
    Biotechnology: Laboratory Analytical Instruments
    Industrials
    Biotechnology: In Vitro & In Vivo Diagnostic Substances
    Health Care
    Get the next $BIO alert in real time by email
    • Q4 2024 revenue of $1.5 million in pharma services; full year revenue of $1.9 million
    • GraftAssure RUO assay launched July 2024
    • Signed strategic partner and investor, Bio-Rad Laboratories
    • Fully funded clinical kitted product development with $50+ million in equity raises
    • Advanced science in transplant; achieved Medicare claims expansion

    IRVINE, Calif., March 24, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp. (NASDAQ:OCX), a diagnostics technology company, today published the following letter to shareholders in conjunction with its fourth quarter results:

    Fellow Shareholders,

    Our dynamic team is making swift progress toward delivering a regulated organ transplant rejection monitoring test kit to the market next year. To be clear, this test kit is the assay that we expect can generate future material and self-sustaining revenue within a few years. In 2024, we began to drive commercial awareness of our tests and capture market share in the estimated $1 billion total addressable transplant rejection testing market.

    We are proud of our ability to stay nimble and move quickly relative to our industry. In 2025, we expect to announce a series of catalysts that build upon our momentum. We expect to announce progress with our multi-center clinical trial of the clinical test kit, commercial expansion of sales of our GraftAssureTM research-use-only (RUO) test kit, and favorable data that further solidify our global credibility in the transplant community. In addition, we expect to deepen our relationships with our existing strategic partners and announce new relationships with additional strategic partners. Meanwhile, our pipeline of commercial contracts continues to strengthen, with leading transplant centers progressing through the stages of assay validation.

    GraftAssure research-use-only (RUO) test kit

    Since our November 2024 update, our confidence in the transplant opportunity has grown in line with the enthusiasm we see among leading transplant centers to participate in our clinical trial as part of our FDA submission. With the clinical trial agreement process already underway, we are eager to name these globally recognized and well-respected institutions in the coming weeks.

    We expect that our clinical trial will be conducted at several leading U.S. transplant centers and a leading transplant research institution in Europe, reinforcing the global credibility of our approach. We are sincerely impressed by the demand that we see among transplant centers to become part of our clinical trial. Their strong interest has exceeded our expectations, underscoring the need for localized and reliable testing solutions.

    To recap the significance of this trial, in January 2023, when we first decided to commercialize our transplant intellectual property (IP) by designing a kitted test, we essentially planted a flag that said we would put our assay through the approval processes of the FDA and its EU equivalent. This decision was significant because in the U.S., we estimate that most complex molecular diagnostics tests are run without FDA authorization and are instead performed in siloed, centralized labs. Moreover, these North American lab tests are not easily accessible to hospitals in the rest of the world. Regulatory authorization is a key step toward achieving our mission to democratize access to these important tests. With regulatory authorization, we anticipate selling test kits to hospital labs, thereby empowering hospitals to run the tests themselves to expediently deliver actionable results.

    It is our belief that if we do the hard work of designing a lab test in kitted form, and achieving regulatory authorization, we will not only democratize access to these tests – thus bringing care closer to the patient and helping hospitals to operate more sustainably – but also create a rapidly growing, high-margin, recurring business model.

    On December 5, 2024, we had our first meeting with the FDA. We were pleased with the collaborative nature of the discussion and our reviewers' feedback. As we continue to develop our kitted product technology alongside our clinical trial, we are targeting submission to the FDA by the end of this year, followed by FDA authorization in 2026.

    Additionally, our research-use-only version of the transplant assay, which has been in the field since July, has generated invaluable feedback from leading transplant center labs, allowing us to refine the product for an enhanced user experience. These collaborations continue to build momentum, increasing awareness within the transplant community and reinforcing the potential for clinical use of digital PCR technology for transplant rejection testing.

    Executive summary

    Oncocyte is at a pivotal stage in commercializing what we expect to be an industry-transforming organ transplant rejection monitoring test. We aim to deliver proven, more affordable, faster tests that can be run at local labs.

    Specifically, we are developing a kitted test that quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). Our scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker1 of transplant rejection, and we are now commercializing that technology using a market disruptive approach.

    Our goal is to enable transplant centers to use our kits to capture the potential patient benefit of a rapid response time and the business benefit of generating laboratory revenue by running the test. In addition to designing a laboratory test in kitted form, our assay uses a digital-PCR workflow that we believe offers distinct advantages over assays run on Next-Generation Sequencing (NGS) technology.

    We expect meaningful revenue in transplant rejection testing after we have reached the clinical in-vitro diagnostic (IVD2) stage of our kitted product development. In the meantime, we believe that customers who are now adopting GraftAssure test kits for research use are motivated in part by the eventual opportunity to use our IVD kits to measure this biomarker in their own labs.

    We also can run our clinical-use assay, VitaGraftTM, at our clinical lab in Nashville, Tenn. We received Medicare reimbursement for the test run at our lab in August 2023.

    Looking back: 2024 Highlights

    Successfully launched the research version of our kitted transplant assay in July 2024: Bringing research centers online with our GraftAssure RUO assay was a key part of our land-and-expand strategy to drive commercial adoption of our tests. This also was an important step toward capturing market share in an estimated $1 billion global total addressable market for transplant rejection testing. In 2H 2024, we signed leading transplant centers in the U.S. and Germany, as well as the UK, Switzerland, Austria, and Southeast Asia. Within six months of launch, transplant centers representing about 9% of German transplant volumes and about 2% of U.S. transplant volumes had signed on to use GraftAssure RUO in its early launch phase.

    Achieved claims expansion for transplant rejection monitoring: In January 2025, we announced that Medicare coverage for our assay expanded following a study showing that monitoring with Oncocyte's assay significantly reduces time to rejection diagnosis in patients with newly developed donor-specific antibodies (DSA). The Molecular Diagnostics program (MolDX) confirmed the use of VitaGraft Kidney to monitor patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). This achievement followed the publication of a groundbreaking study demonstrating VitaGraft Kidney's ability to detect AMR in dnDSA+ patients up to 11 months earlier than the current standard of care. Early detection of transplant rejection is growing in significance as novel therapeutic treatments show promising early results in treating antibody mediated rejection. Indeed, leveraging our clinical assay in our laboratories to support data generation is a key lever in our strategy that increases the market potential for our kitted product.

    Attracted a key strategic partner and investor: In April 2024, we welcomed Bio-Rad Laboratories (NYSE:BIO) as a strategic investor and partner. Bio-Rad subsequently invested in Oncocyte two additional times. Bio-Rad now is a top shareholder, holding approximately 9.66% of Oncocyte's outstanding shares as of today. In addition to its equity investments, Bio-Rad has pledged to provide valuable financial support for the upcoming clinical trial and further commercialization assistance, underscoring the depth of its strategic partnership with Oncocyte.

    Advanced the science of transplant and oncology, with favorable data published in: 

    • The New England Journal of Medicine
    • Transplant International
    • Clinical Cancer Research
    • Nephrology Dialysis Transplantation
    • Acta Neuropathologica Communications

    Completed a productive first meeting with the FDA: As noted above, one of our most significant milestones was our pre-submission meeting with the FDA on December 5, 2024. At that meeting, we received valuable feedback regarding their expectations for marketing authorization of our kitted clinical tests. The FDA clarified that we may proceed using the de novo pathway rather than a 510(k) submission. We view this as a meaningful accomplishment — it establishes a new device category for our kitted test and reinforces the uniqueness and potentially large clinical value of our technology. We are in continuous dialogue with the FDA with the next meeting scheduled in the coming months.

    Fully funded our clinical assay development and streamlined our capital structure: From January 2023 until March 2025, we raised $57 million in equity from new and existing investors. This includes the $29 million from our February 2025 registered direct offering and concurring private placement, in which our five largest shareholders, including Bio-Rad, led the funding round. We expect the offering proceeds to fully fund the development of our transplant assay program through FDA authorization. Also in 2024, we redeemed all remaining shares of our Series A Redeemable Convertible Preferred Stock – positioning us favorably with a streamlined capital structure ahead of a growth inflection point.

    Strengthened our team: In June 2024, in preparation for the next several years of sustained, rapid growth, we welcomed Andrea James as Chief Financial Officer. She has a proven track record of guiding financial strategy through multiple phases of growth, raising and stewarding capital, and building relationships with high quality institutional investors. In January 2025, we appointed Dr. Paul Billings as Consulting Chief Medical Officer. Dr. Billings is a recognized pioneer in genomics and precision medicine with over 40 years of experience spanning academia, government, and the biotechnology industry, including as Chief Medical Officer at Natera, Inc., during the commercialization phase of its blood test for kidney transplant rejection as well as its cancer blood test that can identify minimal residual disease. He also has been an advisor or a physician leader with Laboratory Corporation of America Holdings, Quest Diagnostics, Life Technologies Corp, Johnson & Johnson, and Thermo Fisher Scientific, contributing to transformative advances in molecular medicine. Dr. Billings has substantial experience in commercializing novel assays in precision medicine. He will provide key regulatory and reimbursement support and assist with business development efforts and strategic partnerships.

    Looking Ahead

    We believe that our market opportunity is promising, and that we must continue to focus and execute. As the market shifts away from centralized testing, our easy-to-use technology positions us to potentially lead the transition to decentralized, in-lab diagnostics.

    Also, with favorable data expected later this year regarding our transplant assay, we anticipate further validation of our assay's performance, which we believe will be instrumental in driving adoption and securing payer support.

    Our three major goals this year:

    • Finalizing the clinical assay design: We are locking in ease-of-use improvements based on feedback from some of the most scientifically advanced labs in the world, which have been using GraftAssure kits for research since last year and will be among our expected initial clinical customers.



    • Kicking off, conducting, and concluding our clinical trial: We are finalizing the necessary protocols with the FDA, and ensuring that our clinical trial partners are positioned to deliver robust, high-quality data.
      • For further context, we are designing a prospective, observational, single-arm, multicenter clinical trial to validate our clinical kitted transplant assay, which we intend to name GraftAssureDx. Our study will analyze samples from healthy transplant recipients as well as from those with transplant organ rejection, ensuring statistically robust validation of dd-cfDNA thresholds. The study also will allow for repeat testing across multiple clinical sites. Our key objectives include confirming predefined dd-cfDNA thresholds for detecting transplant rejection, evaluating the test's sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) compared to existing methods, and conducting a repeatability study across a smaller number of sites to ensure test consistency. We expect to successfully determine non-inferiority to existing commercial rejection biomarkers, with expected results meeting or exceeding the sensitivity and specificity benchmarks observed in previous studies, and then submit this data to the FDA. We are planning a second FDA pre-submission meeting to confirm the endpoints with the agency.



    • Spring loading 2H 2026 revenue: We remain on track to meet the commitment that we made to investors in August 2024 to have at least 20 transplant centers signed up for our assay by the end of 2025. We estimate that transplant centers that become customers of our kitted clinical assay each represent a potential annual high-margin revenue stream of several hundred thousand dollars to $2 million of clinical-use tests, depending on the size of the center.

    Beyond the above immediate regulatory and product development objectives, we are preparing for a broader industry shift in transplant care. By 2028, we expect localized, real-time monitoring to become the standard of care, and we believe that we are well-positioned to capture an outsized share of this evolving and growing market.

    The enthusiasm we have seen from transplant centers, patient advocates, and industry partners reinforces our belief that we are building something transformative. We remain confident that the next few years will define the future of transplant diagnostics and solidify our leadership in this space.

    --The Oncocyte Management Team

    Q4 2024 Financial Overview

    • Relative to our strategic objective of commercializing our transplant tests, we consider ourselves to be "pre-revenue." Our reported revenues of $1.5 million in Q4 2024 and $1.9 million for the full year were largely derived from pharma services performed at our clinical laboratory in Nashville. We see this revenue as a testament to our team's ability to achieve the on-time delivery of clear, scientifically sound and accurate data sets to our clients.



    • A gross profit of $595,000 in Q4 2024, representing a 40% gross margin, reflected the cost of materials to perform services at our Nashville laboratory, and the relatively fixed costs of operating that lab, including labor, infrastructure expenses such as the depreciation of laboratory equipment, allocated rent costs, leasehold improvements, and allocated information technology costs. Full year gross profit of $740,000 reflected a 39% gross margin.



    • In Q4 2024, operating expenses of $34.2 million included $41.9 million in non-cash impairment losses offset by a $13.7 million non-cash gain due the change in fair value of our contingent consideration, as well as $499,000 in non-cash stock-based compensation expenses and $522,000 in non-cash depreciation and amortization expenses. Excluding these non-cash items in the current and prior periods, our Q4 2024 operating expenses decreased approximately 12% sequentially and increased 21% year over year.
      • Research and development expenses of $2.3 million declined both sequentially and year over year, reflecting a decrease of 20% and 11%, respectively, largely due to timing regarding laboratory expenses.
      • Sales and marketing expenses of $1.2 million reflected added costs as we commercialize our research-use-only transplant test kits.
      • General and administrative expenses of $2.6 million were flat sequentially, reflecting cost discipline as we focus on investing in research and development on IVD product development, and sales and marketing of GraftAssure.
      • The $41.9 million intangible asset impairment charge we recorded in Q4 2024 reflects our decision to maintain a low rate of investment in our oncology assets as we focus on commercializing transplant. Specifically, we recorded a charge of $35.1 million for DetermaCNI and $6.8 million for DetermaIO. Offsetting that charge in the quarter was a gain of $13.7 million recorded relative to the decline in our contingent consideration liabilities. This liability is tied to our expected future contingency payments to shareholders of companies we had acquired in the past. The liability decline was similarly related to DetermaIO and DetermaCNI, and was partially offset by our increased contingent consideration liability in transplant due to our increased revenue expectations for transplant in the nearer term. The net decrease in our contingent consideration liability was recorded as a gain to operating income, partially offsetting the intangible asset impairment relating to those same assets.



    • On a full-year basis, we believe that the underlying trend in operating expenses highlights our cost discipline. GAAP operating expenses grew from $25.5 million in 2023 to $61.8 million in 2024, with most of the change driven by a $37.8 million change in non-cash impairment losses and contingent consideration fair values. Excluding those non-cash items, GAAP R&D, Sales and Marketing and General and Administrative expenses grew just $716,000 year over year, or 3% -- even while accomplishing all the achievements listed above.
      • General and administrative expenses declined about $978,000 year over year, or 9%, mainly due to cost cutting as well as 2023 severance payments that did not repeat.
      • Research and development expenses grew from $9.3 million in 2023 to $9.8 million in 2024, a $545,000 increase, or 6%, as we continued progress on our assay. Incremental expenses included software development costs of $450,000 related to our clinical kitted product development.
      • Sales and marketing expenses reflect intentional investments in commercialization, growing from $2.8 million in 2023 to $3.9 million in 2024, an increase of about $1.1 million. This included growth in salaries and commission as we signed new top-transplant centers, travel expenses related to signing our European pilot sites, and equipment leasing expenses related to instruments installed at research-use-only assay pilot sites.



    • Our Q4 2024 loss from continuing operations was $33.5 million, or $1.93 per share.
    • Our Q4 2024 Non-GAAP loss from operations was $4.4 million and excludes certain non-cash items. Please refer to the table below, "Reconciliation of Non-GAAP Financial Measure," for additional information.
    • Our Q4 2024 per share results reflect 17.4 million weighted average shares outstanding.
      • Including the shares issued as part of our February 2025 offering and private placement, we currently have 28.6 million shares outstanding.



    • Oncocyte's cash, cash equivalents, and restricted cash balance at the end of the fourth quarter was approximately $10.3 million.
      • We are pleased that our fourth quarter outgoing cash flow from operations (net cash used in operating activities) of $5.4 million, combined with capital expenditures of $0.2 million, came in favorably to our targeted spend $6 million, which was partially a result of operational efficiency and partly a result of working capital management.
      • Please note that our ending year cash balance of $10.3 million excludes the $29.1 million in gross financing cash flow from our registered direct offering and private placement in February 2025.

    Footnotes

    (1)      MolDX, a program that identifies and establishes coverage and U.S. government reimbursement for molecular diagnostic tests, cited our publications twice when it established the LCD (Local Coverage Determination) for Medicare and Medicaid reimbursement coverage for cell free DNA testing. Source: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38671&ver=4

    (2)      The kitted version of our assay must be cleared by regulatory bodies in the U.S., Europe and elsewhere as an in-vitro diagnostic (IVD) to be used in clinical decision making.

    Webcast and Conference Call Information

    Live Zoom Call and Webcast on Monday, March 24, 2025, at 2:00 p.m. PT / 5:00 p.m. ET.

    Those interested may access the live Zoom call by registering here: Oncocyte Q4 2024 Earnings Webinar. Once registered, a confirmation email will be sent with instructions.

    A replay of the Zoom call will be available on the company's website shortly after the call.

    About Oncocyte

    Oncocyte is a diagnostics technology 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/. For more information about our products, please visit the following web pages:

    VitaGraft Kidney™ - https://oncocyte.com/vitagraft-kidney/

    VitaGraft Liver™ - https://oncocyte.com/vitagraft-liver/

    GraftAssure™ - https://oncocyte.com/graftassure/

    DetermaIO™ - https://oncocyte.com/determa-io/

    DetermaCNI™ - https://oncocyte.com/determa-cni/

    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, future expansion and growth, the Company's land-and-expand strategy to drive commercial adoption of its tests and capture market share, plans to have transplant centers running GraftAssure tests through the end of 2025, projected revenue path, IVD strategy, assumptions regarding regulatory approvals, authorizations and clearances, timing and planned regulatory submissions, the ongoing global launch of GraftAssure with the support of Bio-Rad Laboratories, our ability to continue to access capital, 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.

    CONTACT:

    Jeff Ramson

    PCG Advisory

    (646) 863-6893

    [email protected]





    ONCOCYTE CORPORATION


    CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

      December 31,
       2024   2023 
    ASSETS    
    CURRENT ASSETS    
    Cash and cash equivalents $8,636  $9,432 
    Accounts receivable, net of allowance for credit losses of $16 and $5, respectively  1,613   484 
    Inventories  410   — 
    Deferred financing costs  279   — 
    Prepaid expenses and other current assets  821   643 
    Assets held for sale  —   139 
    Total current assets  11,759   10,698 
    NONCURRENT ASSETS    
    Right-of-use and financing lease assets, net  2,757   1,637 
    Machinery and equipment, net, and construction in progress  3,567   3,799 
    Intangible assets, net  14,607   56,595 
    Restricted cash  1,700   1,700 
    Other noncurrent assets  691   463 
    TOTAL ASSETS $35,081  $74,892 
         
    LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY    
    CURRENT LIABILITIES    
    Accounts payable $2,279  $953 
    Accrued compensation  1,939   1,649 
    Accrued royalties  1,116   1,116 
    Accrued expenses and other current liabilities  418   452 
    Right-of-use and financing lease liabilities, current  1,295   665 
    Current liabilities of discontinued operations  —   45 
    Contingent consideration liabilities, current  228   2,314 
    Total current liabilities  7,275   7,194 
    NONCURRENT LIABILITIES    
    Right-of-use and financing lease liabilities, noncurrent  2,369   2,204 
    Contingent consideration liabilities, noncurrent  37,711   39,900 
    TOTAL LIABILITIES  47,355   49,298 
         
    Commitments and contingencies    
         
    Series A Redeemable Convertible Preferred Stock, no par value; stated value $1,000 per share; 5 shares issued and outstanding at December 31, 2023; aggregate liquidation preference of $5,296 as of December 31, 2023  —   5,126 
         
    SHAREHOLDERS' (DEFICIT) EQUITY    
    Preferred stock, no par value, 5,000 shares authorized; no shares issued and outstanding  —   — 
    Common stock, no par value, 230,000 shares authorized; 17,453 and 8,261 shares issued and outstanding at December 31, 2024 and 2023, respectively  338,244   310,295 
    Accumulated other comprehensive income  21   49 
    Accumulated deficit  (350,539)  (289,876)
    Total shareholders' (deficit) equity  (12,274)  20,468 
    TOTAL LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY $35,081  $74,892 





    ONCOCYTE CORPORATION


    UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)

      Three Months Ended

    December 31,
     Years Ended

    December 31,
       2024   2023   2024   2023 
    Net revenue $1,486  $314  $1,881  $1,503 
             
    Cost of revenues  869   409   1,053   1,002 
    Cost of revenues – amortization of acquired intangibles  22   22   88   88 
    Gross profit  595   (117)  740   413 
             
    Operating expenses:        
    Research and development  2,257   2,547   9,839   9,294 
    Sales and marketing  1,202   582   3,944   2,795 
    General and administrative  2,559   1,752   10,204   11,182 
    Change in fair value of contingent consideration  (13,696)  11,185   (4,275)  (5,762)
    Impairment losses  41,900   (4)  41,900   6,757 
    Impairment loss on held for sale assets  —   —   169   1,283 
    Total operating expenses  34,222   16,062   61,781   25,549 
             
    Loss from operations  (33,627)  (16,179)  (61,041)  (25,136)
             
    Other (expenses) income:        
    Interest expense  (30)  (13)  (84)  (52)
    Loss on marketable equity securities  —   (69)  —   (61)
    Other income, net  146   269   462   394 
    Total other income, net  116   187   378   281 
             
    Loss from continuing operations  (33,511)  (15,992)  (60,663)  (24,855)
             
    Loss from discontinued operations  —   —   —   (2,926)
             
    Net loss $(33,511) $(15,992) $(60,663) $(27,781)
             
    Net loss per share:        
    Net loss from continuing operations - basic and diluted $(33,511) $(16,190) $(60,926) $(25,797)
    Net loss from discontinued operations - basic and diluted $—  $—  $—  $(2,926)
    Net loss attributable to common stockholders - basic and diluted $(33,511) $(16,190) $(60,926) $(28,723)
             
    Net loss from continuing operations per share - basic and diluted $(1.93) $(1.96) $(4.66) $(3.37)
    Net loss from discontinued operations per share - basic and diluted $—  $—  $—  $(0.38)
    Net loss attributable to common stockholders per share - basic and diluted $(1.93) $(1.96) $(4.66) $(3.75)
             
    Weighted average shares outstanding - basic and diluted  17,382   8,261   13,071   7,651 





    ONCOCYTE CORPORATION


    UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

      Three Months Ended

    December 31,
     Years Ended

    December 31,
       2024   2023   2024   2023 
    CASH FLOWS FROM OPERATING ACTIVITIES:        
    Net loss $(33,511) $(15,992) $(60,663) $(27,781)
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Depreciation and amortization expense  541   303   1,476   1,592 
    Amortization of intangible assets  22   22   88   88 
    Stock-based compensation  499   484   1,753   2,760 
    Equity compensation for bonus awards and consulting services  50   19   160   127 
    Loss on marketable equity securities  —   69   —   61 
    Change in fair value of contingent consideration  (13,696)  11,185   (4,275)  (5,762)
    Impairment losses  41,900   (4)  41,900   6,757 
    Loss on disposal of discontinued operations  —   —   —   1,521 
    Impairment loss on held for sale assets  —   —   169   1,283 
    Changes in operating assets and liabilities:        
    Accounts receivable  (1,404)  (21)  (1,129)  109 
    Inventories  (178)  —   (410)  — 
    Prepaid expenses and other assets  (113)  139   (458)  784 
    Accounts payable and accrued liabilities  704   (564)  967   (4,757)
    Lease assets and liabilities  (168)  (64)  (291)  (107)
    Net cash used in operating activities  (5,354)  (4,424)  (20,713)  (23,325)
             
    CASH FLOWS FROM INVESTING ACTIVITIES:        
    Proceeds from sale of marketable equity securities  —   367   —   367 
    Proceeds from sale of equipment  4   —   4   354 
    Construction in progress and purchases of furniture and equipment  (214)  (264)  (516)  (281)
    Cash sold in discontinued operations  —   —   —   (1,372)
    Net cash used in investing activities  (210)  103   (512)  (932)
             
    CASH FLOWS FROM FINANCING ACTIVITIES:        
    Proceeds from sale of common shares  10,205   —   26,012   13,848 
    Financing costs to issue common shares  (836)  —   (1,374)  (427)
    Proceeds from sale of common shares under at-the-market transactions  1,784   —   1,802   — 
    Financing costs for at-the-market sales  (234)  —   (421)  — 
    Redemption of Series A redeemable convertible preferred shares  —   —   (5,389)  (1,118)
    Repayment of financing lease obligations  (82)  (30)  (201)  (117)
    Net provided by financing activities  10,837   (30)  20,429   12,186 
             
    NET CHANGE IN CASH, CASH EQUIVALENTS (INCLUDES DISCONTINUED OPERATIONS) AND RESTRICTED CASH  5,273   (4,351)  (796)  (12,071)
             
    CASH, CASH EQUIVALENTS (INCLUDES DISCONTINUED OPERATIONS) AND RESTRICTED CASH, BEGINNING  5,063   15,483   11,132   23,203 
    CASH, CASH EQUIVALENTS AND RESTRICTED CASH, ENDING $10,336  $11,132  $10,336  $11,132 





    Oncocyte Corporation


    Reconciliation of Non-GAAP Financial Measure

    Consolidated Adjusted Loss from Operations

    Note: In addition to financial results determined in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release also includes a non-GAAP financial measure (as defined under SEC Regulation G). We believe that disclosing the adjusted amounts is helpful in assessing our ongoing performance, providing insight into the Company's core operating performance by excluding certain non-cash, and / or intangible items that may obscure the underlying trends in the business. These non-GAAP financial measures, when viewed in a reconciliation to respective GAAP measures, provide an additional way of viewing the Company's results of operations and factors and trends affecting the Company's business. These non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the respective financial results presented in accordance with GAAP.

    The following is a reconciliation of the non-GAAP measure to the most directly comparable GAAP measure:

      Three Months Ended

    December 31,
     Years Ended

    December 31,
       2024   2023   2024   2023 
      (unaudited) (unaudited) (unaudited) (unaudited)
      (In thousands)
    Consolidated GAAP loss from operations $ (33,627) $ (16,179) $ (61,041) $ (25,136)
    Stock-based compensation  499   484   1,753   2,742 
    Depreciation and amortization expenses  563   325   1,564   1,680 
    Change in fair value of contingent consideration  (13,696)  11,185   (4,275)  (5,762)
    Impairment losses  41,900   (4)  41,900   6,757 
    Impairment loss on held for sale assets  —   —   169   1,283 
    Consolidated Non-GAAP loss from operations, as adjusted $ (4,361) $ (4,189) $ (19,930) $ (18,436)


    Primary Logo

    Get the next $BIO alert in real time by email

    Crush Q3 2025 with the Best AI Executive Assistant

    Stay ahead of the competition with Tailforce.ai - your AI-powered business intelligence partner.

    AI-Powered Inbox
    Context-aware email replies
    Strategic Decision Support
    Get Started with Tailforce.ai

    Recent Analyst Ratings for
    $BIO
    $OCX

    CompanyDatePrice TargetRatingAnalyst
    Oncocyte Corporation
    $OCX
    3/28/2025$5.00Buy
    Lake Street
    Bio-Rad Laboratories Inc.
    $BIO
    10/1/2024$350.00 → $400.00Neutral → Buy
    Citigroup
    Bio-Rad Laboratories Inc.
    $BIO
    8/28/2024$340.00Equal Weight
    Wells Fargo
    Bio-Rad Laboratories Inc.
    $BIO
    6/3/2024$315.00Hold
    Jefferies
    Bio-Rad Laboratories Inc.
    $BIO
    4/3/2024$400.00 → $365.00Buy → Neutral
    Citigroup
    Bio-Rad Laboratories Inc.
    $BIO
    12/7/2023$395.00Buy
    UBS
    Bio-Rad Laboratories Inc.
    $BIO
    6/16/2023$550.00Overweight
    Wells Fargo
    Bio-Rad Laboratories Inc.
    $BIO
    12/7/2022$565.00Outperform
    RBC Capital Mkts
    More analyst ratings

    $BIO
    $OCX
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Chief Financial Officer James Andrea S. bought $200,000 worth of shares (97,561 units at $2.05), increasing direct ownership by 182% to 151,231 units (SEC Form 4)

      4 - Oncocyte Corp (0001642380) (Issuer)

      2/11/25 7:00:32 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Large owner Smith Patrick W bought $2,209,080 worth of shares (1,077,600 units at $2.05) and acquired $790,919 worth of shares (385,814 units at $2.05) (SEC Form 4)

      4 - Oncocyte Corp (0001642380) (Issuer)

      2/11/25 5:00:15 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Large owner Broadwood Partners, L.P. bought $10,589,675 worth of shares (5,165,695 units at $2.05) (SEC Form 4)

      4 - Oncocyte Corp (0001642380) (Issuer)

      2/10/25 8:43:04 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care

    $BIO
    $OCX
    SEC Filings

    See more
    • Oncocyte Corporation filed SEC Form 8-K: Submission of Matters to a Vote of Security Holders

      8-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

      7/2/25 5:01:52 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Oncocyte Corporation filed SEC Form 8-K: Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Regulation FD Disclosure, Financial Statements and Exhibits

      8-K - Oncocyte Corp (0001642380) (Filer)

      6/17/25 7:33:46 AM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • SEC Form DEFA14A filed by Oncocyte Corporation

      DEFA14A - Oncocyte Corp (0001642380) (Filer)

      5/14/25 5:08:11 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care

    $BIO
    $OCX
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Oncocyte Changes Name to Insight Molecular Diagnostics Inc. (iMDx), Moves Headquarters to Nashville

      New name aligns with mission to deliver precision biomarker-based testing for both transplant and oncology careiMDx sponsoring GraftAssureIQ™ research-use-only kits at transplant labs globallyExhibiting at European Society of Organ Transplantation (ESOT) conference in London, June 29 – July 2, 2025 NASHVILLE, Tenn., June 17, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. ("iMDx" or the "Company"), (NASDAQ:IMDX), formerly known as Oncocyte Corporation (NASDAQ:OCX), has announced its renaming and the relocation of its principal executive office from Irvine, California, to Nashville, Tennessee. The Company's common stock, listed on the Nasdaq Capital Market, will begin trading

      6/17/25 7:00:00 AM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Bio-Rad's Management to Host Investor Meetings During Jefferies Global Healthcare Conference

      Bio-Rad Laboratories, Inc. (NYSE:BIO), a global leader in life science research and clinical diagnostics products, today announced that the company's Chief Operating Officer Jon DiVincenzo will host one-on-one meetings with investors during the Jefferies Global Healthcare Conference in New York City, on June 4, 2025. About Bio-Rad Bio-Rad Laboratories, Inc. (NYSE:BIO) is a leader in developing, manufacturing, and marketing a broad range of products for the life science research and clinical diagnostics markets. Based in Hercules, California, Bio-Rad operates a global network of research, development, manufacturing, and sales operations with over 7,500 employees, and $2.6 billion in reve

      5/29/25 4:30:00 PM ET
      $BIO
      Biotechnology: Laboratory Analytical Instruments
      Industrials
    • Medicare Boosts Reimbursement for Oncocyte's Flagship Technology

      New price of $2,753 for the GraftAssureCore™ assay increases total addressable market size and margin opportunityBrings pricing in line with existing competitive technologyExpands market appeal for prospective FDA-cleared kitted product at transplant centers IRVINE, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (NASDAQ:OCX), a diagnostics technology company, today provided a positive update on pricing for its next-generation lab-developed test (LDT), GraftAssureCore. The new reimbursement rate strengthens the company's position in the growing transplant rejection testing market and suggests potential upside to its estimated $1 billion total addressable market. The Centers for

      5/19/25 4:05:00 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care

    $BIO
    $OCX
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • Lake Street initiated coverage on OncoCyte with a new price target

      Lake Street initiated coverage of OncoCyte with a rating of Buy and set a new price target of $5.00

      3/28/25 8:35:58 AM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Bio-Rad Labs upgraded by Citigroup with a new price target

      Citigroup upgraded Bio-Rad Labs from Neutral to Buy and set a new price target of $400.00 from $350.00 previously

      10/1/24 7:11:23 AM ET
      $BIO
      Biotechnology: Laboratory Analytical Instruments
      Industrials
    • Wells Fargo initiated coverage on Bio-Rad Labs with a new price target

      Wells Fargo initiated coverage of Bio-Rad Labs with a rating of Equal Weight and set a new price target of $340.00

      8/28/24 7:34:48 AM ET
      $BIO
      Biotechnology: Laboratory Analytical Instruments
      Industrials

    $BIO
    $OCX
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Director Arno Andrew was granted 55,000 shares, increasing direct ownership by 67% to 136,554 units (SEC Form 4)

      4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

      7/3/25 4:05:25 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Director Silverman Lou was granted 35,000 shares, increasing direct ownership by 2,238% to 36,564 units (SEC Form 4)

      4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

      7/3/25 4:05:34 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Director Last Andrew J. was granted 35,000 shares, increasing direct ownership by 776% to 39,509 units (SEC Form 4)

      4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

      7/3/25 4:05:22 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care

    $BIO
    $OCX
    Financials

    Live finance-specific insights

    See more
    • Oncocyte to Release First Quarter 2025 Results on May 12, 2025

      IRVINE, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (NASDAQ:OCX), a leading diagnostics technology company, today announced that it will report first quarter 2025 financial results after the market closes on Monday, May 12, 2025. Oncocyte will host a live Zoom webinar to discuss the company's financial results at 2:00 p.m. PT that same day. The live webinar to discuss financial results, followed by Q&A, will be accessible via registration at the following link: Oncocyte Q1 2025 Earnings Webinar. An archived replay will be available after the call concludes on Oncocyte's investor relations website at https://investors.oncocyte.com. About Oncocyte Oncocyte is a pioneering di

      5/7/25 4:10:00 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Bio-Rad Reports First-Quarter 2025 Financial Results

      Bio-Rad Laboratories, Inc. (NYSE:BIO), a global leader in life science research and clinical diagnostics products, today announced financial results for the first quarter ended March 31, 2025. Norman Schwartz, Bio-Rad's Chairman and Chief Executive Officer, stated: "We navigated a highly dynamic first quarter that became progressively more challenging, yet we delivered solid margins through focused execution and careful expense management. Given the current levels of market uncertainty, we are moderating our full-year 2025 outlook to reflect the evolving macro environment. Going forward, we remain committed to advancing our growth and margin expansion initiatives." Financial Results Highl

      5/1/25 4:15:00 PM ET
      $BIO
      Biotechnology: Laboratory Analytical Instruments
      Industrials
    • Oncocyte Provides Positive Update on Clinical Trial Progress

      Central Institutional Review Board approved, final preparatory steps underway at first transplant centersThree of the top 10 U.S. transplant centers expected to participate in trialNearly 10% of annual U.S. transplant volume represented in trial site interestPreparing for final Q-sub FDA meeting ahead of clinical validation IRVINE, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (NASDAQ:OCX), a leading diagnostics technology company, today provided a positive update on its substantial progress toward initiating its clinical trial, which is a major step required to obtain regulatory authorization to deliver an organ transplant rejection monitoring test kit to the market. Oncoc

      4/30/25 8:30:00 AM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care

    $BIO
    $OCX
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • Amendment: SEC Form SC 13G/A filed by Oncocyte Corporation

      SC 13G/A - Oncocyte Corp (0001642380) (Subject)

      12/9/24 5:30:06 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • SEC Form SC 13G filed by Oncocyte Corporation

      SC 13G - Oncocyte Corp (0001642380) (Subject)

      11/14/24 1:26:16 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Amendment: SEC Form SC 13G/A filed by Oncocyte Corporation

      SC 13G/A - Oncocyte Corp (0001642380) (Subject)

      10/24/24 12:13:28 PM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care

    $BIO
    $OCX
    Leadership Updates

    Live Leadership Updates

    See more
    • Veradigm Announces Board Expansion and Changes

      Appoints Vinit Asar and Louis Silverman to its Board of Directors Agrees to Add Two Additional Directors Veradigm® (OTC:MDRX) ("Veradigm" or the "Company"), a leading provider of healthcare data and technology solutions, announced today it has entered into a Cooperation Agreement (the "Agreement") with Kent Lake PR LLC ("Kent Lake"). The Agreement aligns with the Board's request for input from shareholders regarding board composition on January 30, 2025, and a desire to conduct an orderly refreshment of the Board following the conclusion of the exploration of strategic alternatives. As part of the Agreement, the Board has appointed two new independent directors, Vinit Asar and Louis Silve

      2/20/25 4:02:00 PM ET
      $MDRX
      $OCX
      $ZIMV
      EDP Services
      Technology
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Oncocyte Appoints Dr. Paul Billings as Consulting Chief Medical Officer

      Dr. Billings is a renowned diagnostics specialist with a history of commercializing novel assays in precision medicineWill provide key regulatory and reimbursement supportWill assist business development efforts and strategic partnerships IRVINE, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp. (NASDAQ:OCX), a diagnostics technology company, announces the appointment of Dr. Paul Billings as the company's Consulting Chief Medical Officer. In this part-time role, he will support a range of strategic and clinical goals for Oncocyte. Dr. Billings is a recognized pioneer in genomics and precision medicine with over 40 years of experience spanning academia, government,

      1/8/25 8:30:00 AM ET
      $OCX
      Biotechnology: In Vitro & In Vivo Diagnostic Substances
      Health Care
    • Palantir Technologies, Dell Technologies, and Erie Indemnity Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600

      NEW YORK, Sept. 6, 2024 /PRNewswire/ -- S&P Dow Jones Indices ("S&P DJI") will make the following changes to the S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices effective prior to the open of trading on Monday, September 23, to coincide with the quarterly rebalance. The changes ensure each index is more representative of its market capitalization range. All companies being added to the S&P 500 are more representative of the large-cap market space, all companies being added to the S&P MidCap 400 are more representative of the mid-cap market space, and all companies being added to the S&P SmallCap 600 are more representative of the small-cap market space. The companies being removed from

      9/6/24 6:43:00 PM ET
      $AAL
      $ADMA
      $ADNT
      $AMCX
      Air Freight/Delivery Services
      Consumer Discretionary
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care