Release Date: March 24, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- OncoCyte Corp (OCX, Financial) launched Graft Assure, a kidney transplant test, with leading transplant centers, enhancing their IVD product development.
- The company achieved a breakthrough designation for a drug from the FDA, signaling potential market expansion.
- OncoCyte Corp (OCX) published data showing their assay can detect organ rejection 11 months ahead of standard protocols, leading to Medicare claims expansion.
- The company attracted a strategic partner, Bio-Rad Laboratories, which participated in all three equity funding rounds, strengthening their financial position.
- OncoCyte Corp (OCX) successfully raised $29 million in February, ensuring a financial runway of over a year and supporting their clinical assay development.
Negative Points
- There are macro uncertainties around federal government actions that could affect OncoCyte Corp (OCX)'s timeline for FDA submissions.
- The company is not projecting any material revenue from their RUO product this year, indicating potential delays in revenue generation.
- OncoCyte Corp (OCX) faces competition from established lab-based competitors with a significant market presence.
- The FDA submission timeline has been pushed back by two quarters, partly due to uncertainties in the regulatory environment.
- The company anticipates higher cash burn in Q2 and Q3 due to bonuses and incremental sales and marketing expenses.
Q & A Highlights
Q: Can you explain the regulatory pathway for your assay and the expected timeline for FDA approval?
A: (Josh Riggs, CEO) We are using the de novo pathway, which is expected to take about seven months. This pathway was chosen because there is no predicate device for donor-derived cell-free DNA. We anticipate submitting our data package to the FDA by the end of this year, with an approved product on the market by mid-2026.
Q: How many centers are required for the FDA package, and how many patients need to be enrolled?
A: (Josh Riggs, CEO) We need a minimum of three sites for reproducibility work, but we expect to double that in the US and have additional centers in Europe. (Ecky Schutz, CSO) We need about 150 biopsy-matched samples to provide statistically significant results.
Q: What are your expectations for revenue from the RUO product before FDA clearance?
A: (Josh Riggs, CEO) We do not project any material revenue from the RUO product this year. The significant revenue opportunity lies in the regulated product in the US and Europe. We are incorporating feedback from beta sites and expect potential revenue generation in the second half of this year.
Q: What clinical evidence will be prioritized post-FDA approval to drive broader utilization?
A: (Josh Riggs, CEO) We have strong data showing our assay's clinical utility, including publications in the New England Journal of Medicine. Post-approval, we will focus on kidney transplants initially, then expand to heart, liver, and lung transplants. We aim to demonstrate our assay's effectiveness compared to existing tests.
Q: How do you plan to drive early utilization of your assay, considering reimbursement risks?
A: (Josh Riggs, CEO) We plan to bridge reimbursement from our service lab to the kitted product within MLAs, which will aid adoption. Centers will likely start with cautious adoption, gradually increasing usage as they integrate the assay into their systems. We expect significant revenue growth starting in 2027.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
