ProKidney Q2 2023 Earnings Report
Key Takeaways
ProKidney reported financial results for the second quarter ended June 30, 2023. The company had cash, cash equivalents and marketable securities totaling $446.1 million as of June 30, 2023. Research and development expenses were $26.4 million for the three months ended June 30, 2023, and general and administrative expenses were $13.5 million for the same period. Net loss before noncontrolling interest was $34.8 million for the three months ended June 30, 2023.
Closed on purchase of a 210,000 square foot facility in Greensboro, N.C. to support future potential commercial manufacturing needs for REACT.
Received an incentive package totaling up to approximately $33.7 million in tax credits, as well as up to $1.9 million in energy credits from Duke Energy.
Continued enrolling subjects in proact 1, a Phase 3 study evaluating REACT, with initial interim data expected by the end of 2024.
Continued preparation to initiate patient enrollment in proact 2, a Phase 3 study to assess the safety and efficacy of REACT, with initial interim data expected by the end of 2025.
ProKidney
ProKidney
Forward Guidance
The company expects to reach several important inflection points in the coming months, including updated interim data from its Phase 2 RMCL-002 study in the second half of 2023, potentially furthering an understanding of the durability of kidney function preservation found with REACT in patients with advanced stage CKD. Around the end of 2023, the company is also planning to report on the progress of participants in its open-label Phase 2 REGEN-007 study of REACT.
Positive Outlook
- Updated interim data from Phase 2 RMCL-002 study in the second half of 2023 may further understanding of kidney function preservation with REACT.
- Planning to report on progress of participants in open-label Phase 2 REGEN-007 study of REACT around the end of 2023.
- Potential for REACT to preserve kidney health and delay the need for dialysis in patients with advanced CKD.
- Purchase of Greensboro facility expected to expand future manufacturing capacity for potential commercial launch of REACT.
- Receipt of incentives based upon achievement of certain milestones, including job creation and project investment.
Challenges Ahead
- Inability to maintain the listing of the Company’s Class A ordinary shares on the Nasdaq.
- 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.
- 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.
- The impact of COVID-19 or geo-political conflict such as the war in Ukraine on the Company’s business.