Oncocyte Reports Q1 2025 Results and Business Progress

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]