During manufacturing pause, ProKidney increases R&D spending to $106.7M

ProKidney site in Greensboro
A photo taken Nov. 1 captures the site where ProKidney plans a $458 million facility in Greensboro.
Lloyd Whittington
Lillian Johnson
By Lillian Johnson – Reporter, Triad Business Journal

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2023 was a big year for ProKidney, the Winston-Salem regenerative medicine company, as it announced a combined $479 million in local investments and 380 in new jobs. Here's how the company fare financially during the year.

With its pause on manufacturing still ongoing, ProKidney (NASDAQ: PROK) reported a $127.3 million decrease in its cash position at the end of 2023.

The regenerative medicine company had cash, cash equivalents and marketable securities of $363 million at year’s end, down from $490.3 million at the end of 2022. However, ProKidney said it expects that this cash will “fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025.”

The company said last week that it will continue its temporary manufacturing pause, which it announced in November, just months after announcing one of the largest manufacturing investments in Triad history. Affecting two of its studies, the pause is expected to end in mid-2024.

The company is set to build a $458 million commercial manufacturing plant in Greensboro, adding 330 employees, and invest $21 million in a headquarter expansion in Winston-Salem, adding 50 employees.


GO DEEPER: Why 2024 is a critical year for ProKidney


The Winston-Salem public company has developed a cell therapy platform, known as REACT or rilparencel, that aims to restore kidney function in patients with diabetic chronic kidney disease by using a patient’s own healthy renal cells.

“Our clinical data to date have shown that rilparencel may meet a current unmet medical need by preserving kidney function and delaying the onset of dialysis in high-risk patients with chronic kidney disease caused by Type 2 diabetes,” said Bruce Culleton, who was appointed CEO in November. “Rilparencel has the potential to be very meaningful to this high-risk patient population where there are limited options for care outside of preparing for transplantation or dialysis.”

Dr. Bruce Culleton, CEO
Dr. Bruce Culleton, CEO of ProKidney.
ProKidney

ProKidney also reported its research and development expenses for the 2023 at $106.7 million for the full year, up from $82.1 million in 2022. The company is in the process of gaining FDA approval for rilparencel.

It attributed the increase to a $17.2 million increase in cash and equity compensation as it hires personnel in clinical development, quality, manufacturing and biostatistics; a $16.6 million increase in clinical trial costs related to its Phase 3 study; and a $4.7 million increase in costs related to manufacturing improvements, materials and professional fees. These costs were offset by decreases in equity-based payments for a third-party service used in 2022, the company said.

ProKidney’s general and administrative expenses were down for the year at $44.8 million from $70.9 million. The company said the decrease was driven by recognitions of equity-based compensation costs in 2022.

The company’s net loss decreased from $148.1 million to $135.4 million year-over-year.

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