Release Date: May 12, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- OncoCyte Corp (OCX, Financial) has finalized its clinical trial design and received central IRB approval, marking a significant milestone in its strategic pivot towards transplant rejection testing.
- The company is on track to submit a data package to the FDA by the end of the year, with FDA approval targeted for the first half of 2026.
- There is strong interest from top transplant centers in the US and Germany to participate in the clinical trial, representing nearly 10% of US transplant volumes.
- OncoCyte Corp (OCX) has successfully expanded its RUO assay to 10 sites across the US, Germany, UK, Switzerland, Austria, and Southeast Asia, with researchers exploring new applications for the tests.
- The company reported Pharma Services revenue of $2.1 million, exceeding expectations and extending its cash runway, with gross margins of 62%.
Negative Points
- Pharma Services revenue is situation-driven and expected to vary, with Q2 revenue anticipated to be less than $500,000, highlighting potential revenue volatility.
- The company's oncology pipeline, while promising, is still in the early stages compared to its transplant focus, indicating a longer timeline for revenue generation in this area.
- OncoCyte Corp (OCX) is undergoing a corporate rename, which, although budget-conscious, may cause temporary brand recognition challenges.
- The company anticipates a couple of quarters with increased cash burn due to clinical trial costs and FDA-compliant software development, impacting financial stability.
- There is uncertainty regarding the speed at which transplant centers will adopt the new test post-FDA approval, as these centers are generally risk-averse and may require time to integrate new technologies.
Q & A Highlights
Q: Can you expand on the interest from a larger pharma customer regarding oncology kits?
A: Josh Riggs, CEO: The interest is primarily around Determa IO and its potential as a standalone PCR assay or in conjunction with a larger NGS panel. The data is seen as differentiating, especially in challenging cancers like colon cancer.
Q: What are the next milestones for Determa IO, and when might it represent a tangible revenue opportunity?
A: Josh Riggs, CEO: We submitted for reimbursement in December 2022 and are awaiting results. The SWAG study, involving 800 patients, is a significant milestone, with results expected towards the end of the year, potentially at the San Antonio Breast Cancer Symposium.
Q: What feedback have you received from large US transplant centers about participating in your study?
A: Josh Riggs, CEO: The centers are enthusiastic and eager to access the technology. They are interested in answering complex questions that are difficult with only send-out options. The partnership approach is fostering strong relationships.
Q: How do you anticipate the iota model impacting market growth?
A: Josh Riggs, CEO: The model is expected to increase demand for testing as more marginal organs are used, leading to more adverse events. This will drive the need for tools to manage patients, and we are hopeful that new drugs will mitigate some negative effects.
Q: What is the focus of the final Q-sub meeting with the FDA, and what has been de-risked?
A: Ecky Schutz, Chief Science Officer: We are submitting the CSA to the FDA and have had productive pre-meetings. The FDA has provided clear guidance on what they want to see, which we have incorporated into our QA. We are on track to submit by the end of the year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
