Core Insights - Oncocyte Corp. is focused on launching its first clinical molecular diagnostic test kit for transplant rejection testing, targeting a $1 billion market opportunity [1][8][25] - The company reported $2.1 million in pharma services revenue for Q1 2025, with gross margins improving from 40% in Q4 2024 to 62% in Q1 2025 due to operational efficiencies [2][31] Clinical Trial Progress - Oncocyte has completed the clinical trial design for its diagnostic testing kit and received approval from a central institutional review board (IRB) [4] - The company expects participation from at least three of the top 10 transplant centers in the U.S., which represent nearly 10% of U.S. transplanted organ volume [5][7] - The upcoming clinical trial is anticipated to meet clinical evidence requirements for FDA submission, with clearance expected in 2026 [8] Business Update - Ten leading transplant centers are currently using Oncocyte's GraftAssure research-use-only kits, with plans to expand to at least 20 centers by the end of 2025 [11] - The GraftAssure test is expected to generate annual revenue of several hundred thousand dollars up to $2 million per center once FDA clearance is achieved [11] - The company is rebranding its product portfolio, with GraftAssure becoming the umbrella brand for its dd-cfDNA test portfolio [24][22] Financial Overview - Q1 2025 revenues were $2.14 million, with a gross profit of $1.33 million, reflecting a 62% gross margin [31][36] - Operating expenses for Q1 2025 totaled $8.1 million, leading to a net loss of $6.7 million, or ($0.26) per share [31][36] - The company ended Q1 2025 with $32.7 million in cash and equivalents, bolstered by a recent financing round [31][38]

Company Announcement - Oncocyte Corp. will report its first quarter 2025 financial results after the market closes on May 12, 2025 [1] - A live Zoom webinar will be held at 2:00 p.m. PT on the same day to discuss the financial results [1][2] Investor Information - The webinar will include a Q&A session and requires registration for access [2] - An archived replay of the webinar will be available on Oncocyte's investor relations website after the call concludes [2] Company Overview - Oncocyte is a diagnostics technology company focused on democratizing access to novel molecular diagnostic testing to enhance patient outcomes [3]

Core Viewpoint - Oncocyte Corp. is making significant progress towards initiating a clinical trial for an organ transplant rejection monitoring test kit, which is essential for obtaining regulatory authorization to market the product [1][6]. Company Progress - Oncocyte has completed the clinical trial design and received approval from a central institutional review board (IRB) [2]. - The company expects to include three of the top 10 transplant centers in the U.S. as participants in the clinical trial, representing nearly 10% of the U.S. transplanted organ volume [3]. - Oncocyte estimates that transplant rejection testing generates approximately $500 million in annual revenue in the U.S., with a global addressable market exceeding $1 billion [4]. Market Engagement - The transplant community is enthusiastic about the opportunity to conduct testing in-house, with major transplant centers supporting Oncocyte's efforts [5]. - Oncocyte plans to announce its National Principal Investigator (NPI) soon and will host a conference call to introduce this key opinion leader [5]. Regulatory Pathway - The upcoming clinical trial is the only requirement for FDA authorization of Oncocyte's test kit, which is being pursued through a Class II de novo pathway [6]. - Oncocyte is preparing for its second and final Q-Submission (Q-Sub) meeting with the FDA, following productive discussions in previous meetings [7][8].

Core Viewpoint - Oncocyte Corp. has published new data on its blood-based transplant rejection assay, indicating significant advancements in understanding organ rejection and potential market expansion opportunities for monitoring high-risk patients [1][4]. Scientific Significance - The study demonstrates a correlation between microvascular and vascular inflammation and elevated donor-derived cell-free DNA (dd-cfDNA) levels in blood plasma, enhancing the understanding of organ rejection biology [2]. - Two novel observations were made: T-cell mediated rejection (TCMR) is linked to high dd-cfDNA levels in the presence of vascular inflammation, while calcineurin inhibitor toxicity does not elevate dd-cfDNA levels [7][8]. Strategic Significance - The research supports the long-term management of high-risk transplant patients using Oncocyte's proprietary test, which is positioned to disrupt the market with more affordable and faster testing options [4][5]. - The study's findings validate the clinical utility of dd-cfDNA testing over a decade post-transplant, indicating its relevance in ongoing patient management [5]. - A significant portion of patients with organ rejection also exhibited de novo donor-specific antibodies, aligning with Oncocyte's previous clinical trial findings that led to expanded Medicare reimbursement [6]. Market Expansion - Oncocyte is developing a kitted version of its assay for local lab use, aiming to enhance accessibility and affordability of transplant monitoring tests [3]. - The collaboration with Charité University in Berlin has been instrumental in advancing scientific knowledge in transplantation, further solidifying Oncocyte's position in the market [4].

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 ...

Core Insights - Oncocyte Corp. will participate in the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025, with CEO Josh Riggs and CFO Andrea James attending [1][3] - The focus of the discussion will be on Oncocyte's innovative diagnostic technologies and the progress towards commercializing a regulated organ transplant rejection monitoring test kit [2][4] Company Overview - Oncocyte is a diagnostics technology company that provides tests aimed at enhancing clarity and confidence for physicians and patients [4] - 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 for predicting response to immunotherapies - DetermaCNI™: A blood-based monitoring tool for assessing therapeutic efficacy in cancer patients [4][5]

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]

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 significant participation from its largest shareholders, including Bio-Rad [35][36] Business Line Data and Key Metrics Changes - The company launched GraftAssure, a kidney transplant test, which has been utilized at leading transplant centers, providing valuable feedback for product development [5][8] - 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 finalizing the assay design and launching clinical trials [18] - The company is monitoring macro uncertainties around federal government funding that could affect timelines but remains optimistic about the FDA review process [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] - The company is focused on operational efficiency, which has allowed it to maintain a strong cash position while advancing its clinical assay development [34][38] Q&A Session Summary Question: Regulatory pathway and timing for FDA approval - The company is budgeting seven months for the de novo pathway, which is preferred due to the lack of a predicate device for donor-derived cell-free DNA [44] Question: Number of centers required for 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: Timing of FDA submission - The company is cautiously optimistic about enrolling 150 patients quickly, but is being conservative due to uncertainties in the regulatory environment [52] Question: Revenue from GraftAssure kits before FDA clearance - The company does not project material revenue from the RUO product this year, with significant revenue expected post-FDA clearance [57] Question: Bio-Rad's support for clinical trials - The company expects Bio-Rad to provide support for instruments and consumables, which will offset a significant portion of trial expenses [60] Question: Clinical evidence priorities post-FDA approval - The company plans to invest in heart, liver, and lung assays after establishing its kidney transplant assay [66] Question: Integration of the assay into existing workflows - The assay is designed to be easy to integrate into existing workflows, requiring minimal additional education for labs already performing HLA testing [75] Question: Competition response to market entry - The company anticipates competitors will highlight their experience and patient sample volume, but believes its FDA study will demonstrate the assay's clinical utility [81]

Investment Highlights - Oncocyte is taking a disruptive approach to molecular diagnostic testing by empowering local labs with kits, contrasting the central lab model[14] - The company has secured a go-to-market strategic partner and equity investment[14] - Oncocyte has a science-driven team experienced in molecular diagnostics and rapid growth[14] - The company possesses a full R&D pipeline to fuel growth and portfolio expansion over the next decade[14] - Oncocyte's IP portfolio is attractive to partners and enables value protection[14] Transplant Market - Kidney transplant patients face a 20.2% chance of developing Antibody-Mediated Rejection (AMR) within 10 years of transplant, and up to 70% of those patients will progress to graft failure[43] - The US market supports $500 million in annual revenue for Laboratory Developed Tests (LDTs), which is currently generated by competitors[79] - The global transplant testing market is currently a $1 billion Total Addressable Market (TAM) and can expand to approximately $2 billion with claims expansion[67, 79] - Global transplants are growing at approximately 9% per year[68] Oncology Market - The estimated Total Addressable Market (TAM) for oncology in the US alone is $2 billion[97, 98] - The estimated Total Addressable Market (TAM) for Copy Number Instability (CNI) in the US Market is $4 billion[101] - There are 26 million estimated annual global testing opportunities for oncology[97] - There are 78 million estimated annual global testing opportunities for Copy Number Instability (CNI)[101]

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].