Loading...
•
Dec 31, 2022
ProKidney Q4 2022 Earnings Report
Reported financial results for the fourth quarter ended December 31, 2022.
Key Takeaways
ProKidney reported its Q4 2022 financial results, highlighting a cash position of $490.3 million, R&D expenses of $20.9 million, and G&A expenses of $9.3 million. The company's net loss before noncontrolling interest was $24.6 million.
Continued enrolling subjects in proact1, a Phase 3 randomized, blinded, sham-controlled study evaluating up to two doses of REACT given three months apart.
Received allowance of the proact1 study protocol from the UK Medicines and Healthcare Products Regulatory Agency, Health Canada and the Taiwan Food and Drug Administration.
Continued to progress toward the initiation of proact2, a Phase 3 randomized, blinded, sham-controlled study to assess the efficacy of up to two REACT injections.
Cash and cash equivalents as of December 31, 2022, were $490.3 million, compared to $20.6 million on December 31, 2021.
ProKidney
ProKidney
Forward Guidance
The company expects to report topline data from proact1 by the end of 2024 which, if positive, could help support a future BLA submission for potential U.S. regulatory approval.
Positive Outlook
- Initial interim data from proact1 expected at the end of 2024.
- Balance sheet, strengthened by the more than $500 million in net proceeds from PIPE financing in July 2022, will be sufficient to fund operations through 2024.
- Regular interactions with the physician community at key medical congresses, aimed at broadening awareness of REACT among physicians.
- REACT has received Regenerative Medicine Advanced Therapy (RMAT) designation.
- Received favorable scientific advice from the European Medicines Agency on the adequacy of Phase 3 development program.
Challenges Ahead
- The risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry.
- The inability of the Company to raise financing in the future.
- The inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product.
- The inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases.
- Uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities.