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]

Company Overview - Oncocyte Corp. is a pioneering diagnostics technology company focused on providing clarity and confidence to physicians and their patients [2] - The company offers several diagnostic tests, including VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™, which are designed for solid organ transplantation monitoring and cancer treatment efficacy [2] Conference Participation - Oncocyte's CEO Josh Riggs and CFO Andrea James will attend BTIG's MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, Utah on February 11-12, 2025 [1] - The company will host one-on-one meetings with interested investors during the conference [1] Product Information - 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™ is a gene expression test that evaluates the tumor microenvironment to predict responses to immunotherapies [2] - DetermaCNI™ is a blood-based tool for monitoring therapeutic efficacy in cancer patients [2]

Core Viewpoint - Oncocyte Corp. has announced a registered direct offering and concurrent private placement, aiming to raise $29.1 million to fund its FDA In-Vitro Diagnostic transplant assay program, which is crucial for driving self-sustaining revenue [1][2][4]. Funding Details - The funding round is led by Oncocyte's five largest shareholders, including Bio-Rad Laboratories, with shares priced at $2.05 each [2][7]. - The total gross proceeds from the offerings are expected to be $29.1 million, with 3,609,755 shares sold in the registered direct offering and 7,536,708 shares in the PIPE offering [7][8]. Strategic Partnership - Bio-Rad has committed not only to equity investment but also to providing financial support for upcoming clinical trials and commercialization efforts, highlighting the strength of their strategic partnership [3][10]. Use of Proceeds - The proceeds from the offerings will be utilized for working capital and general corporate purposes, specifically to fund the development of Oncocyte's transplant assay program through FDA clearance [4][5]. Market Potential - Oncocyte aims to capture a share of the $1 billion global transplant testing market, with a focus on improving patient outcomes through innovative diagnostic solutions [6][10]. Technology and Impact - Oncocyte's proprietary technology is designed for transplant centers, offering a simple workflow and rapid results, which can detect kidney transplant rejection signs over 11 months earlier than standard protocols [5][6]. Future Outlook - The company anticipates rapid adoption of its technology post-FDA clearance, with a commitment to financial discipline and capital stewardship as core values moving forward [6][10].

Core Insights - Oncocyte Corp. has appointed Dr. Paul Billings as Consulting Chief Medical Officer to support strategic and clinical goals [2][3] - Dr. Billings is a pioneer in genomics and precision medicine with over 40 years of experience in academia, government, and biotechnology [3][5] - The appointment is expected to enhance Oncocyte's capabilities in regulatory support, reimbursement, business development, and strategic partnerships [6] Company Overview - Oncocyte is a diagnostics technology company focused on providing clarity and confidence to physicians and patients through its tests [7] - Key products include VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™, which are designed for organ transplantation monitoring and cancer treatment efficacy [7][8] - The company aims to improve patient care by enabling testing closer to patients with quality and favorable economics [4]

Core Insights - Oncocyte Corp. has achieved a significant milestone in advancing patient care for kidney transplant patients through the expansion of its VitaGraft Kidney test, which is now confirmed for monitoring patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR) [2][3][11] Group 1: Product Development and Market Expansion - The Molecular Diagnostics program (MolDX) has confirmed the use of VitaGraft Kidney for monitoring dnDSA+ patients, demonstrating its ability to detect AMR up to 11 months earlier than current standards [3][11] - Oncocyte aims to commercialize its proprietary diagnostic technology, which quantifies donor-derived cell-free DNA (dd-cfDNA), allowing local laboratories to run tests more affordably and quickly [5][8] - The expansion of Medicare coverage for VitaGraft Kidney under Local Coverage Determination (LCD) L38568 enhances the total addressable market for the assay, particularly for high-risk patients [6][11] Group 2: Clinical Significance and Impact - Early detection of AMR is critical, as up to 20% of kidney transplant patients may develop detectable DSA within five years, with a significant risk of allograft loss [10] - The test's ability to monitor anti-CD38 therapy is highlighted as a key feature, emphasizing the importance of early detection in the context of emerging therapeutic options [4][10] - The positive coverage decision from Palmetto GBA in August 2023 marks a pivotal step in the commercialization of the assay, confirming its eligibility for Medicare reimbursement [6][10]

IRVINE, Calif., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Oncocyte Corp. (NASDAQ: OCX), a diagnostics technology company, today announced the publication of favorable data regarding its DetermaCNI™ assay. In a paper recently published in the journal Acta Neuropathologica Communications, DetermaCNI showed promise as a liquid biopsy method for diagnosing and profiling central nervous system tumors by measuring somatic copy number aberrations (SCNAs) in cerebrospinal fluid. For context, copy number instability (CNI) i ...

Oncocyte first to published randomized interventional data to rule-in for biopsy in high-risk patient population Study shows that monitoring with Oncocyte’s assay significantly reduces time to rejection diagnosis in patients with newly developed donor-specific antibodies Early detection of transplant rejection is growing in significance as novel therapeutic treatments show promising early results in antibody mediated rejection. Study published in Nephrology Dialysis Transplantation  IRVINE, Calif., Dec. 02, ...