Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- OncoCyte Corp (OCX, Financial) is making significant progress in democratizing transplant testing, with their technology now being run on three continents.
- The company has signed leading transplant centers in key markets and is on track to meet or exceed its site placement goal of having 20 sites signed by the end of next year.
- Demand for the Graf Ruo kit test is exceeding expectations in both Europe and the US, indicating strong market interest.
- OncoCyte Corp (OCX) has engaged with the FDA and is preparing for a meeting to discuss their validation plan, showing progress towards regulatory clearance.
- The company successfully raised $10.2 million in gross proceeds in a private placement, providing financial runway to continue executing on strategic goals.
Negative Points
- OncoCyte Corp (OCX) is still largely pre-revenue in the transplant sector, indicating a reliance on future developments for financial growth.
- The company faces challenges in convincing transplant centers to adopt new technology, as it requires buy-in from both transplant and lab managers.
- There is a lead-in period expected for new adopters of their IVD product, which could delay revenue generation post-FDA clearance.
- The company operates in a tough environment for raising capital, which could impact future funding efforts.
- OncoCyte Corp (OCX) is navigating a highly competitive market with existing NGS tests, requiring them to differentiate their digital PCR-based assay.
Q & A Highlights
Q: Can you discuss the role that Borra is playing over the next year before potential FDA approval? Are they assisting in opening dialogues with transplant centers or individual physicians?
A: (Josh Riggs, CEO) Borra has been very supportive, especially in Germany, where they have strong relationships with labs. This partnership gives us a larger presence and credibility, especially at conferences. In the U.S., they have opened doors where we don't have reach, providing significant support and credibility.
Q: How has the reception been for the Graf Assure workflow among physicians? Is the teaching process intuitive?
A: (Josh Riggs, CEO) Most molecular labs are familiar with PCR technology, so the workflow isn't foreign. Training on the Biore platform takes about one to two weeks, and we've had no significant challenges. The process is straightforward, and labs are generating their own data comfortably.
Q: Can you discuss the value of Videra, especially for high-risk transplant patients? Will it be used for a subset of patients needing expedited results?
A: (Josh Riggs, CEO) The Graf Assure assay is for research use only, but the IVD product, Biograph Plus, will be used clinically. Transplant centers will be incentivized to run tests in-house, and while the market hasn't experienced same-day turnaround, we expect it to be a significant driver for in-house testing.
Q: What are the decision-making processes at transplant centers for adopting the RUO product, and what are common pushbacks?
A: (Josh Riggs, CEO) Decision-making involves both transplant and lab managers. We target research-minded nephrologists or surgeons who want to bring technology in-house for studies. The main hurdle is adopting a new instrument with limited content, but demand for access to technology often wins.
Q: Why wouldn't people just use existing NGS tests?
A: (Ek Schutz, Chief Science Officer) Digital PCR is faster than NGS, which can take 24-30 hours for results. NGS requires batching samples, which isn't feasible for urgent cases. Our test allows for immediate results, making it more suitable for critical situations.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
