Oncocyte(US:OCX)2025-03-24 22:53Financial 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]