Oncocyte(OCX) - 2025 Q3 - Quarterly Results

Financial Performance - iMDx reported revenues of $260,000 in Q3 2025, primarily from laboratory services, with no revenue from kitted product sales expected until regulatory clearance is achieved[29]. - Gross profit for Q3 2025 was $139,000, resulting in a gross margin of 53.5%[30]. - Operating expenses in Q3 2025 totaled $11.2 million, with a 6% sequential increase excluding non-cash charges[30]. - The net loss for Q3 2025 was $10.9 million, or ($0.34) per share, with a non-GAAP loss from operations of $6.6 million[30]. - For the three months ended September 30, 2025, the net loss was $10,854,000, compared to a net loss of $13,493,000 for the same period in 2024, representing a 19.4% improvement[41]. - The company reported a consolidated GAAP loss from operations of $11,048,000 for the three months ended September 30, 2025, compared to $13,515,000 for the same period in 2024, reflecting an 18.3% reduction in losses[43]. - The company reported a consolidated non-GAAP loss from operations of $6,565,000 for the three months ended September 30, 2025, compared to $5,585,000 for the same period in 2024, indicating a 17.5% increase in adjusted losses[43]. - Cash, cash equivalents, and restricted cash at the end of Q3 2025 amounted to $20.2 million, with net cash used in operating activities of $4.6 million[36]. - Total current assets increased to $21.4 million as of September 30, 2025, compared to $11.8 million at the end of 2024[39]. - Total liabilities increased to $53.1 million as of September 30, 2025, compared to $47.4 million at the end of 2024[39]. - The cash used in operating activities for the nine months ended September 30, 2025, was $16,639,000, compared to $15,338,000 for the same period in 2024, indicating an 8.5% increase in cash outflow[41]. - The net provided by financing activities for the nine months ended September 30, 2025, was $28,324,000, compared to $9,592,000 for the same period in 2024, reflecting a 195.5% increase[41]. - Stock-based compensation for the three months ended September 30, 2025, was $521,000, up from $450,000 in the same period of 2024, showing a 15.7% increase[43]. - The change in fair value of contingent consideration was $3,378,000 for the three months ended September 30, 2025, compared to $7,140,000 for the same period in 2024, indicating a 52.7% decrease[43]. - The net cash used in investing activities for the three months ended September 30, 2025, was $1,050,000, compared to $87,000 for the same period in 2024, indicating a substantial increase in investment spending[41]. - The depreciation and amortization expense for the three months ended September 30, 2025, was $584,000, compared to $340,000 for the same period in 2024, representing a 72% increase[43]. Product Development and Market Strategy - The company is on track to submit GraftAssureDx for FDA review by the end of 2025, aiming for a mid-2026 product launch[5][20]. - iMDx anticipates reaching $100 million in annual high-margin revenue, growing at a double-digit pace, once GraftAssureDx is marketed[3]. - The Centers for Medicare & Medicaid Services (CMS) improved reimbursement for the assay to $2,753 per result, enhancing the financial outlook for the product[8]. - iMDx aims to engage 20 transplant centers globally with GraftAssure technology by the end of 2025, with 11 centers currently participating in clinical trials[5][22]. - The company is expanding its product line to include heart transplant testing, leveraging early data that suggests GraftAssureDx may be a best-in-class diagnostic[25]. - A 5,000-participant registry program is expected to generate real-world data across approximately 50 transplant centers, collecting an estimated 50,000 samples over six years[23]. - iMDx has made significant progress in clinical trial site engagement, with 11 sites now collecting samples for the GraftAssureDx validation study[15][22]. - The company has successfully hosted a Key Opinion Leader event, enhancing clinician engagement and interest in the GraftAssure family of products[22]. - iMDx's strategic partnership with Bio-Rad Laboratories is critical for the development and supply of instrumentation and reagents necessary for GraftAssureDx[19].