Revenue Performance - Total net revenue increased to $260,000 for the three months ended September 30, 2025, representing a 126% increase from $115,000 in the prior period[230]. - Net revenue for the nine months ended September 30, 2025, reached $2.9 million, a significant increase of 638% compared to $395,000 in the same period of 2024[230]. - Laboratory Services revenue increased by $145,000 in Q3 2025, primarily from one existing customer, contributing approximately $260,000[232]. - Laboratory Services revenue increased by $2.5 million, reaching approximately $2.9 million in 2025, with a significant increase of 675% compared to the previous year[236]. - Total revenue for the nine months ended September 30, 2025, was $2.916 million, a 638% increase from $395,000 in 2024[237]. Net Loss - Net loss for the three months ended September 30, 2025, was $10.9 million, a decrease of $2.6 million from a net loss of $13.5 million in the prior year[232]. - Net loss for the nine months ended September 30, 2025, was $27.3 million, slightly higher than the net loss of $27.2 million in the comparable prior period[234]. - The net loss for the nine months ended September 30, 2025, was $27.3 million, slightly higher than the net loss of $27.2 million for the same period in 2024[261][263]. Expenses - Research and development expenses rose by $1.1 million in Q3 2025, driven by ongoing development of multiple diagnostic tests[232]. - Sales and marketing expenses increased by $343,000 in Q3 2025, reflecting ramped-up activities related to the transplant business and oncology commercialization efforts[232]. - Research and development expenses rose by $2.5 million, totaling $3.878 million for the three months ended September 30, 2025, reflecting a 38% increase year-over-year[241]. - Sales and marketing expenses increased by $1.3 million, totaling $1.386 million for the three months ended September 30, 2025, representing a 33% increase compared to the same period in 2024[243]. - General and administrative expenses increased by $662,000, mainly due to higher personnel-related expenses and board fees[236]. - General and administrative expenses for the three months ended September 30, 2025, were $2.5 million, a decrease of 1% compared to $2.6 million in the same period of 2024[245]. - Total research and development expenses for the nine months ended September 30, 2025, were $10.1 million, compared to $7.6 million for the same period in 2024, representing a 33% increase[261][263]. Cash Flow and Financing - Cash used in operating activities during the nine months ended September 30, 2025, amounted to $16.6 million, compared to $15.4 million in the same period of 2024[261][263]. - Cash provided by financing activities during the nine months ended September 30, 2025, was $28.3 million, primarily from net cash proceeds of $28.7 million from the February 2025 Offering[265]. - As of September 30, 2025, the company had $18.7 million in cash and cash equivalents, indicating a need for continued capital access to finance operations[252]. Contingent Consideration and Impairments - The change in fair value of contingent consideration was a loss of $3.4 million in Q3 2025, compared to a loss of $7.1 million in the same quarter of 2024[235]. - The change in fair value of contingent consideration resulted in a loss of $7.1 million in 2025, an improvement from a loss of $9.4 million in 2024[236]. - As of September 30, 2025, total contingent consideration liabilities were $45.0 million, an increase from $37.9 million as of December 31, 2024[273]. - During the nine months ended September 30, 2025 and 2024, the company recorded losses of $7.1 million and $9.4 million, respectively, related to the fair value of contingent consideration[273]. - The company recorded a total impairment of $41.9 million for certain oncology-related IPR&D intangible assets during the year ended December 31, 2024, with no impairments recorded in 2025[275]. - An impairment loss of $169,000 was recognized on held-for-sale assets during the nine months ended September 30, 2024, with no such impairments recorded in 2025[276]. Future Outlook and Strategic Initiatives - The company expects to continue incurring significant research and development expenses as it develops GraftAssureCore, GraftAssureIQ, GraftAssureDx, DetermaIO, and DetermaCNI[241]. - The company has initiated a clinical trial in support of its transplant products, with an IVD submission expected by the end of 2025[242]. - Future sales and marketing expenditures will depend on the revenue generated from the commercialization of diagnostic tests, particularly if they qualify for reimbursement by Medicare or private health insurance[244]. - The company is focusing on commercializing its transplant kitted tests and signing new laboratory customers, which may impact future Laboratory Services revenue[231]. - The company has expanded its Nashville and Germany facilities and acquired 14 new machines for operations as of September 30, 2025[257]. - The company is exploring marketing arrangements with distributors in other countries to commercialize diagnostic tests and reduce capital needs[255]. Allowance for Credit Losses - As of September 30, 2025, the allowance for credit losses related to Laboratory Services was $3,000, down from $16,000 as of December 31, 2024[278]. Stock-Based Compensation - Total stock-based compensation recognized during the nine months ended September 30, 2025 and 2024 was $1.5 million and $1.3 million, respectively[279].
Oncocyte(OCX) - 2025 Q3 - Quarterly Report