ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular therapeutics company focused on preserving kidney function in patients suffering from chronic kidney disease (CKD), today announced its agreement to purchase a 210,000 square foot facility and approximately 22 acres of land in Greensboro, N.C., to support the Company’s future commercial manufacturing needs for REACT®, its proprietary REnal Autologous Cell Therapy, currently in Phase 3 development for the treatment of diabetic CKD. Under the purchase agreement, ProKidney will pay approximately $25.5 million in cash for the facility and property. The transaction is expected to close by the end of June 2023, subject to customary closing conditions. The Company plans to make investments in the facility through 2028 to prepare for potential commercial-scale manufacturing.
“This purchase represents an important component of our strategic manufacturing buildout,” said Dr. Tim Bertram, Chief Executive Officer of ProKidney. “With a staged investment strategy based on the clinical trial success of REACT, potential regulatory approval, and ultimately commercial demand, if approved, we intend, along with our current Winston-Salem facility, to supply enough REACT to match initial commercial demand. Subject to the outcome of the proact 1 and proact 2 clinical trials, we are targeting a Biological Licensing Agreement submission for Food and Drug Administration approval of REACT in 2026. Approval is projected to be followed by a possible commercial launch in the U.S. later that year. With these timelines in mind, we are developing our infrastructure in preparation for ProKidney’s potential shift to a commercial organization.”
In connection with the purchase agreement, the city of Greensboro, N.C., Guilford County, N.C., and the North Carolina State Economic Investment Committee have approved an incentive package under which ProKidney is eligible to receive up to $13.3 million in tax credits based upon the achievement of certain milestones, including the creation of at least 330 new jobs on or before December 31, 2028 and project investment of approximately $458 million made, or caused to be made, by the company in real and personal property by December 31, 2027.
ProKidney’s previous financial guidance remains unchanged, anticipating that cash as of March 31, 2023, will fund operations through the reporting of interim results from proact 1, expected in late 2024.
CKD is a serious diagnosis with significant morbidity and mortality. Notably, the 5-year mortality of newly diagnosed Stage 4 CKD is higher than that of newly diagnosed non-metastatic cancer. CKD most often presents as a progressive decline in kidney function, ultimately resulting in the failure of the kidneys and the need for renal replacement therapy, such as hemodialysis or kidney transplant. One in three Americans is at risk for CKD, which currently affects approximately 75 million people in the United States and Europe and over 400 million across Asia. CKD is among the largest single expense incurred by the U.S. health care system.