OncoCyte (OCX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Individual investors often ...

IRVINE, Calif., April 02, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp. (Nasdaq: OCX), a leading diagnostics technology company, today announced that Chief Executive Officer Josh Riggs and Chief Financial Officer Andrea James will attend the 24th Annual Needham Virtual Healthcare Conference, taking place from April 7-10, 2025. In addition, CEO Josh Riggs will participate in a fireside chat at the conference. During the event, Josh and Andrea will discuss Oncocyte’s innovative diagnostic technologies and will high ...

Financial Data and Key Metrics Changes - In Q4, the company reported pharma services revenue of $1.5 million with a gross margin of 40%, exceeding expectations [27][28] - The outgoing cash flow in Q4 was $5.6 million, favorable to the targeted spend of $6 million, finishing the year with $10 million in cash [33][34] - The company successfully raised an additional $29 million in February, with major shareholders leading the funding round [35][36] Business Line Data and Key Metrics Changes - The company launched GraftAssure, a kidney transplant test, which has been valuable for IVD product development [5][11] - The company expects to have 20 transplant centers signed up by the end of 2025, translating to approximately $20 million in future annual recurring revenue [21] Market Data and Key Metrics Changes - The company achieved Medicare claims expansion to monitor high-risk transplant patients, potentially expanding the total addressable market by up to 20% [10] - The rollout of iota this summer is expected to increase the use of more marginal organs, contributing to market expansion over the next five years [11] Company Strategy and Development Direction - The company is focused on finalizing assay design, launching clinical trials, and submitting data packages to the FDA, with a projected timeline for market approval by mid-2026 [18] - The company aims to deepen relationships with potential strategic partners through its pharma services business, which provides non-dilutive capital [28][30] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about 2025, emphasizing the importance of regulatory submissions and clinical trials [18] - The company is monitoring macro uncertainties around federal government funding that could affect timelines [15][17] Other Important Information - The company is committed to disciplined cash management, targeting about $6 million per quarter in cash burn for 2025 [39][38] - The company is focused on operational efficiency, which has allowed it to maintain a strong cash position [34] Q&A Session Questions and Answers Question: What is the regulatory pathway and timing for FDA approval? - The company is budgeting seven months for the de novo pathway, as there is no clear predicate device for donor-derived cell-free DNA [44] Question: How many centers are required for the FDA package? - A minimum of three sites is required for reproducibility work, with expectations to double that in the US and include centers in Europe [46][49] Question: Will there be material revenue before FDA clearance? - The company does not project any material revenue from the RUO product this year, with significant revenue expected post-FDA clearance [57] Question: What support will Bio-Rad provide for clinical trials? - Bio-Rad is expected to provide support for instruments and consumables, offsetting a significant portion of trial expenses [60] Question: How will the company drive broader utilization post-FDA approval? - The company plans to bridge reimbursement from its service lab to the kitted product, expecting faster adoption within the MolDX jurisdiction [68] Question: How easy is the offering to integrate into existing workflows? - The workflow is streamlined, requiring only two pipetting steps, making it easy for existing labs to adopt [75]

Gabby Woody Joining us today are Oncocyte President and CEO, Josh Riggs; Chief Science Officer, Ekke Schutz; and CFO, Andrea James. We also have our analysts with us as panelists. After our prepared remarks, our analysts may ask questions. Attendees may also type questions into the Q&A. Before turning the call over to Josh Riggs, I'd like to go over our safe harbor. The company will make projections and forward-looking statements regarding future events. Any statements that are not historical facts are forw ...

Investor Presentation NASDAQ: OCX March 2025 oncocyte.com Forward looking statements Safe-Harbor Statement This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on Oncocyte's management's beliefs and assumptions and on information currently available to management. 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 ...

Financial Performance - Total net revenue increased to $1.9 million for the year ended December 31, 2024, compared to $1.5 million in 2023, representing a 25% increase [266]. - Loss from continuing operations was $60.7 million for the year ended December 31, 2024, compared to $24.9 million in 2023, an increase of 144% [268]. - Consolidated net loss for the year ended December 31, 2024, was $60.7 million, significantly higher than the $27.8 million loss in 2023, indicating a 118.7% increase in losses [295][296]. - Cash used in operating activities for 2024 amounted to $20.7 million, slightly lower than the $23.3 million used in 2023, showing an 11.1% decrease [295][296]. - Net cash provided by financing activities in 2024 was $20.4 million, an increase from $12.2 million in 2023, representing a 67.7% growth [298][299]. Revenue and Expenses - Pharma Services revenue increased by $392,000, with a total of $1.9 million in 2024, reflecting a 27% increase from $1.5 million in 2023 [269]. - Sales and marketing expenses rose by $1.1 million, primarily due to increased activities related to the transplant business and oncology commercialization efforts [268]. - Research and development expenses totaled $9.839 million in 2024, a 6% increase from $9.294 million in 2023, with personnel-related expenses rising by 21% [272]. - Sales and marketing expenses increased by 41% to $3.944 million in 2024, compared to $2.795 million in 2023, driven by a 43% rise in personnel-related expenses [274]. - General and administrative expenses decreased by 9% to $10.204 million in 2024 from $11.182 million in 2023, with a notable reduction in stock-based compensation by 38% [275]. Impairment and Losses - Impairment losses surged to $41.9 million in 2024, a 520% increase from $6.8 million in 2023 [266]. - Impairment losses for in-process research and development intangible assets amounted to $41.9 million in 2024, compared to $5.0 million in the prior year [271]. - The company recorded a total impairment of $41.9 million for intangible assets as of December 31, 2024, following a $5.0 million impairment recorded in March 2023 [308]. Strategic Initiatives - The company expects to begin commercializing its oncology product line, including DetermaIO, over the next 15 months [260]. - The company entered into a global strategic partnership with Bio-Rad on April 5, 2024, to develop and commercialize transplant products [289]. - The company plans to explore various commercialization options to enter overseas markets and reduce capital needs, including potential joint ventures [288]. - The company is focusing on regulatory approvals for its kitted tests to support future distribution and higher sales for clinical use [258]. - The company plans to pursue clinical trials for DetermaIO in 2025, contingent on the diagnostic test's development progress [273]. Financing Activities - The company entered into a sales agreement for an at-the-market facility to offer up to $7.5 million in common stock, with net proceeds of approximately $1.7 million received by December 31, 2024 [264]. - A registered direct offering in February 2025 generated approximately $29.1 million in gross proceeds [265]. - The company raised approximately $29.1 million in gross proceeds from the February 2025 Offering, netting about $28.7 million after expenses [287]. Tax and Regulatory Matters - The company established a full valuation allowance for deferred tax assets due to uncertainty in realizing future tax benefits [279]. - The company accounts for income taxes using the asset and liability method, with potential changes in market conditions affecting deferred tax asset realizability [313]. - No amounts were accrued for the payment of interest and penalties related to unrecognized tax benefits as of the financial statement periods presented [314]. - The company is currently unaware of any tax issues under review by relevant taxing authorities [314]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk [315]. Other Financial Metrics - Total other income, net increased by $97,000 in 2024, primarily due to additional interest income compared to 2023 [271]. - Cash used in investing activities for 2024 was $512,000, a decrease from $932,000 in 2023, reflecting a 45.0% reduction [297]. - Total contingent consideration liabilities as of December 31, 2024, were $37.9 million, down from $42.2 million in 2023, indicating a 10.2% decrease [306]. - As of December 31, 2024, the allowance for credit losses related to Pharma Services was $16,000, an increase from $5,000 in 2023 [311]. - Total stock-based compensation recognized for the years ended December 31, 2024, and 2023 was $1.8 million and $2.8 million, respectively [312].

Financial Performance - Q4 2024 revenue reached $1.5 million in pharma services, with a full year revenue of $1.9 million[6] - Reported revenues of $1.5 million in Q4 2024 and $1.9 million for the full year, primarily from pharma services[5] - Net revenue for Q4 2024 was $1,486,000, compared to $314,000 in Q4 2023, representing a 373% increase[32] - Gross profit for Q4 2024 was $595,000, a significant improvement from a gross loss of $117,000 in Q4 2023[32] - Q4 2024 gross profit of $595,000, representing a 40% gross margin, with a full-year gross profit of $740,000 at a 39% gross margin[5] - The net loss for Q4 2024 was $33,511,000, compared to a net loss of $15,992,000 in Q4 2023, indicating a 109% increase in losses[32] - For the full year 2024, the consolidated GAAP loss from operations totaled $61.04 million, compared to $25.14 million in 2023[36] - The adjusted consolidated Non-GAAP loss from operations for the full year 2024 was $19.93 million, compared to $18.44 million in 2023[36] Operating Expenses - Operating expenses in Q4 2024 totaled $34.2 million, with a 12% sequential decrease and a 21% year-over-year increase when excluding non-cash items[5] - Full-year operating expenses grew from $25.5 million in 2023 to $61.8 million in 2024, primarily due to non-cash impairment losses[5] - Total operating expenses increased to $34,222,000 in Q4 2024 from $16,062,000 in Q4 2023, reflecting a 113% rise[32] - Research and development expenses decreased by 20% sequentially and 11% year-over-year to $2.3 million in Q4 2024[5] - Research and development expenses were $2,257,000 in Q4 2024, down from $2,547,000 in Q4 2023, a decrease of 11%[32] - Sales and marketing expenses increased to $1.2 million in Q4 2024 as the company commercializes research-use-only transplant test kits[5] - Sales and marketing expenses rose to $1,202,000 in Q4 2024, compared to $582,000 in Q4 2023, marking a 106% increase[32] Cash and Assets - Cash, cash equivalents, and restricted cash balance at the end of Q4 2024 was approximately $10.3 million[6] - The company reported a net cash increase of $5,273,000 in Q4 2024, contrasting with a decrease of $4,351,000 in Q4 2023[33] - Total assets decreased from $74.892 million in 2023 to $35.081 million in 2024, reflecting significant impairment charges[31] Strategic Developments - The GraftAssure research-use-only assay was launched in July 2024, capturing approximately 9% of German transplant volumes and 2% of U.S. transplant volumes within six months[15] - Medicare coverage for the VitaGraft Kidney assay expanded in January 2025, significantly reducing time to rejection diagnosis in patients with newly developed donor-specific antibodies[16] - The company expects to submit its kitted product technology to the FDA by the end of 2025, with authorization anticipated in 2026[8] - Oncocyte aims to have at least 20 transplant centers signed up for its kitted clinical assay by the end of 2025, with each center representing potential annual revenue of several hundred thousand dollars to $2 million[24] - The company signed a strategic partnership with Bio-Rad Laboratories, which now holds approximately 9.66% of Oncocyte's outstanding shares[17] - The clinical trial for the kitted test is expected to be conducted at several leading U.S. transplant centers and a prominent research institution in Europe[4] - The company plans to have transplant centers running GraftAssure tests through the end of 2025 as part of its growth strategy[29] Technology and Product Development - Oncocyte's kitted test leverages digital PCR technology to measure donor-derived cell-free DNA, aiming to democratize access to transplant rejection testing[11] - The company anticipates meaningful revenue growth in transplant rejection testing after reaching the clinical in-vitro diagnostic stage of its product development[13] Impairment and Losses - Impairment losses significantly increased to $41.90 million in Q4 2024, up from a minimal loss in Q4 2023[36] - Change in fair value of contingent consideration showed a loss of $13.70 million in Q4 2024, contrasting with a gain of $11.19 million in Q4 2023[36] - The total impairment loss on held for sale assets was recorded at $169,000 for the full year 2024[36]

Core Insights - Oncocyte Corp. is progressing towards launching a regulated organ transplant rejection monitoring test kit, expected to generate significant revenue in the coming years [1][10][22] - The company aims to capture a share of the estimated $1 billion market for transplant rejection testing, with a focus on commercializing its GraftAssure research-use-only test kit [1][15][22] Company Developments - In 2025, Oncocyte plans to announce advancements in its multi-center clinical trial for the clinical test kit and expand sales of the GraftAssure RUO test kit [2][3] - The company has signed a strategic partnership with Bio-Rad Laboratories, which has invested approximately 9.66% of Oncocyte's outstanding shares [5][17] - Oncocyte's clinical trial will take place at leading transplant centers in the U.S. and Europe, reflecting strong interest from these institutions [4][8] Financial Overview - Q4 2024 revenue was reported at $1.5 million, with a full-year revenue of $1.9 million, primarily from pharma services [5][26] - The company achieved a gross profit of $595,000 in Q4 2024, representing a 40% gross margin [26] - Operating expenses for Q4 2024 totaled $34.2 million, influenced by non-cash impairment losses [26][27] Regulatory and Market Position - Oncocyte is targeting FDA submission for its kitted product by the end of 2025, with authorization expected in 2026 [8][18] - The company aims to democratize access to transplant rejection tests, allowing hospitals to conduct tests in-house [6][7] - Medicare coverage for Oncocyte's assay has expanded, highlighting its clinical significance in early detection of transplant rejection [16] Future Outlook - The company anticipates that localized, real-time monitoring will become the standard of care by 2028, positioning itself to capture a significant market share [22][23] - Oncocyte is focused on enhancing its product based on feedback from leading transplant centers, which will aid in driving adoption [9][25]

Core Points - Oncocyte Corp. will report its fourth quarter 2024 financial results on March 24, 2025, after market close [1] - A live Zoom webinar will be held at 2:00 p.m. PT on the same day to discuss the financial results and include a Q&A session [2] Company Overview - Oncocyte is a leading diagnostics technology company focused on providing clarity and confidence to physicians and patients through its tests [3] - Key products include: - VitaGraft™, a clinical blood-based solid organ transplantation monitoring test - GraftAssure™, a research use only (RUO) blood-based solid organ transplantation monitoring test - DetermaIO™, a gene expression test predicting response to immunotherapies - DetermaCNI™, a blood-based monitoring tool for therapeutic efficacy in cancer patients [3]

Group 1 - Oncocyte Corp. will participate in BTIG's MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, Utah on February 11-12, 2025 [1][2] - The company will host one-on-one meetings with interested investors during the conference [1] - Oncocyte is recognized for its innovative diagnostics technology, including tests like VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ [2] Group 2 - VitaGraft™ is a clinical blood-based test for solid organ transplantation monitoring [2] - GraftAssure™ is a research use only (RUO) blood-based test for solid organ transplantation monitoring [2] - DetermaIO™ assesses the tumor microenvironment to predict response to immunotherapies, while DetermaCNI™ monitors therapeutic efficacy in cancer patients [2]