OncoCyte Corp ((OCX)) has held its Q4 earnings call. Read on for the main highlights of the call.
The recent earnings call for OncoCyte Corp reflected a generally positive sentiment, highlighting significant achievements and strategic advancements. The company celebrated the successful launch of GraftAssure, strategic partnerships, and clinical progress, while also acknowledging potential regulatory challenges. Despite these hurdles, the overall outlook remains optimistic, with expectations of continued growth and expansion.
Launch of GraftAssure and Market Expansion
OncoCyte Corp successfully launched GraftAssure, a research use-only kidney transplant test, in collaboration with leading transplant centers. This launch has expanded the total addressable market by up to 20%, positioning the company for meaningful market growth over the next five years.
Strategic Partnership with Bio-Rad Laboratories
The company secured a strategic partnership with Bio-Rad Laboratories, a key player that has participated in all three equity funding rounds over the past year. This partnership is expected to help mitigate expenses and support clinical trial and commercialization efforts.
Medicare Claims Expansion and Regulatory Progress
OncoCyte achieved Medicare claims expansion to monitor high-risk transplant patients and had a positive pre-submission meeting with the FDA. The company is preparing for a final submission later this year, marking significant regulatory progress.
Financial Performance and Fundraising Success
The company reported Q4 pharma services revenue of $1.5 million with a gross margin of 40%. OncoCyte ended the year with $10 million in cash and raised an additional $29 million in February through a clean transaction without incentive warrants or discounts.
Clinical and Scientific Advancements
A groundbreaking study published in the New England Journal of Medicine led to FDA breakthrough designation for felzartamab. The study demonstrated the assay’s ability to detect organ rejection 11 months ahead of standard protocols.
Strong Team and Operational Efficiency
OncoCyte strengthened its leadership team with the addition of new CFO Andrea James and Consulting Chief Medical Officer Dr. Paul Billings. The company continues to focus on operational efficiency, maintaining favorable outgoing cash flow relative to targeted spending.
Regulatory Timeline Uncertainties
The company faces potential delays in the FDA review process due to macro uncertainties and staffing changes at the FDA Center for Devices and Radiological Health. As a result, the submission timeline for FDA approval has been adjusted to the end of the year.
Variable Pharma Services Revenue
Pharma services revenue is expected to be lower in the first half of 2025 compared to Q4 2024, as the company shifts focus to supporting FDA submission and strategic priorities.
Forward-Looking Guidance
OncoCyte provided a comprehensive update on their future plans, emphasizing the successful launch of GraftAssure and its impact on assay design and user experience. The company discussed upcoming regulatory submissions in the US and Europe, with a projected FDA approval timeline by mid-2026. They aim to expand their total addressable market by up to 20%, supported by a breakthrough FDA designation. Financially, OncoCyte aims to sign 20 transplant centers by the end of 2025, targeting $20 million in future annual recurring revenue.
In conclusion, OncoCyte Corp’s earnings call showcased a positive outlook with strategic achievements and financial success. The company is poised for growth, despite facing potential regulatory delays. Key takeaways include the launch of GraftAssure, strategic partnerships, and clinical advancements, all contributing to a promising future for OncoCyte.