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Oncocyte(OCX) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Pharma services revenue for the quarter was $2.1 million, exceeding expectations due to a large order processed quickly, resulting in $1.4 million invoiced just days before the quarter ended [16][17] - The company ended the first quarter with nearly $33 million in cash, including restricted cash, and reported a free cash flow of negative $6.2 million, aligning with the target average quarterly cash burn of $6 million [19][20] Business Line Data and Key Metrics Changes - The majority of revenue in Q1 came from a single corporate customer, which has led to potential partnership opportunities for one of the oncology assays [17] - The company has 10 sites running its research use only (RUO) assay across various regions, including the US, Germany, UK, Switzerland, Austria, and Southeast Asia [9][10] Market Data and Key Metrics Changes - The company expects to have 20 sites trained on its graft assay workflow by the end of the year, which is part of a strategy to land hospitals with the RUO product and expand to selling the clinical kitted product post-FDA clearance [9][12] - Interest from several university hospitals in the clinical trial has been noted, with expectations to include at least three of the top 10 transplant centers in the US [6][9] Company Strategy and Development Direction - The company is focused on finalizing its clinical assay and trial design, preparing for an FDA submission by the end of the year, and expanding its customer base in the transplant sector [5][8] - A corporate name change is planned to better reflect the strategic direction, moving away from the name OncoCyte, which no longer aligns with the company's primary focus on transplant [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made towards building a sustainable business in the transplant market, with increasing interest from potential corporate partners [15] - The company anticipates that the strong interest in the clinical trial will translate into future demand for its IVD assay [7][8] Other Important Information - The company is investing in improving and simplifying digital PCR workflows, which are seen as a differentiator compared to NGS, particularly for transplant centers with lower sample volumes [10][11] - The company is preparing for a significant increase in cash burn due to clinical trial costs and FDA-compliant software development [20] Q&A Session Summary Question: Can you expand on the larger revenue-generating pharma customer interested in oncology? - Management confirmed that the interest is related to DetermaIO and a kitted version, with potential for collaboration on immunotherapy response [24] Question: What are the next milestones for DetermaIO? - The company is looking forward to data from the SWOG study involving 800 patients, which is expected to be reported towards the end of the year [26][28] Question: What feedback has been received from US transplant centers regarding the study? - Management described the relationship with transplant centers as enthusiastic, with a strong desire for access to the technology [30] Question: How does the company view the impact of the IOTA model on market growth? - Management acknowledged skepticism from partners but remains hopeful for increased demand for testing tools as more marginal organs are used [39] Question: What is the focus for the upcoming Q-sub meeting with the FDA? - The focus will be on finalizing the submission and addressing specific questions from the FDA to ensure acceptance of the final submission [48]