aibioProKidney sets up at-the-market program for up to $200,000,000 of stock with Jefferies
Tickers PROK
Jefferies earns up to 3.0% of gross proceeds on the new $200,000,000 program. The stock last sold at $4.54 on July 11, 2025, and the second dosing group in the Phase 2 REGEN-007 trial missed statistical significance.
Key facts
- Company
- ProKidney Corp. (NASDAQ: PROK)
- News type
- Financings
- Primary source
- ProKidney Corp. 424B5 (2025-07-14)
The new sales program
ProKidney Corp. signed an Open Market Sale Agreement with Jefferies LLC on July 14, 2025, under which it may sell up to $200,000,000 of Class A common stock through Jefferies as sales agent. Sales can be made on The Nasdaq Capital Market or other venues, in the over-the-counter market, in privately negotiated deals, or through a market maker. Jefferies is entitled to up to 3.0% of the gross proceeds of the shares it sells, and ProKidney reimburses certain expenses. The company has no obligation to sell and may suspend the offering at any time.
The 8-K filed the same day says the agreement replaces an earlier Open Market Sale Agreement with Jefferies dated January 19, 2024. The two companies mutually terminated the 2024 agreement effective July 14, 2025. The 8-K also says Jefferies has provided, and may provide, financial advisory and investment banking services for customary fees. Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. gave the opinion on the validity of the shares. Paul Hastings LLP of New York represents Jefferies in the offering, and Mintz of Boston passes on the validity of the shares.
The shares are sold under a shelf registration on Form S-3, first filed on November 22, 2023 and declared effective on November 30, 2023. A post-effective amendment filed on July 3, 2025 was declared effective on July 7, 2025, and this supplement is dated July 14, 2025.
The price and the use of proceeds
The supplement uses a last reported sale price of $4.54 per Class A share on the Nasdaq Capital Market on July 11, 2025. It says the number of shares issued will vary with the sales price. There is no minimum sale amount, and management will have broad discretion over the proceeds. It intends to use the money for clinical trial costs, other research and development, its drug development platform, pre-commercial and commercial activities including its commercial manufacturing facility, and general corporate purposes.
The supplement does not give a cash balance or a net loss for 2025. It lists 163,161,681 Class B shares to be outstanding after the offering, and says 26,761,945 shares were reserved for future issuance under the 2022 Incentive Equity Plan as of March 31, 2025.
The lead drug and its Phase 2 data
ProKidney describes itself as a clinical-stage biotechnology company with a cell therapy platform for chronic kidney disease. Its lead product candidate is rilparencel, also known as REACT, an autologous cell therapy in a Phase 3 trial called REGEN-006 (PROACT 1), which has received RMAT designation from the FDA. The company says the Phase 3 trial is ongoing and plans to enroll about 685 subjects. It has no approved products and has not generated product revenue.
The supplement presents topline results from REGEN-007, a Phase 2 open-label randomized study. It randomized 53 patients, of whom 49 received at least one injection. Both arms received rilparencel, so the study has no untreated comparison. Group 1 repeated the Phase 3 dosing schedule. In Group 1 (24 patients), the annual eGFR decline improved from minus 5.8 mL/min/1.73m2 before injection to minus 1.3 after the last injection. That difference of 4.6 was statistically significant.
Group 2 (25 patients) tested an exploratory schedule with a second injection triggered by disease progression. Its improvement, from minus 3.4 to minus 1.7, was 1.7 per year and not statistically significant, with a p value of 0.085. The company says the result suggests a dose response, but the difference did not reach statistical significance. Median follow-up after the last injection was about 18 months. The company reports no serious adverse events related to rilparencel in the 49 patients treated.
What comes next
ProKidney says full REGEN-007 results will be submitted as a late-breaking clinical trial at the 2025 American Society of Nephrology Kidney Week. The Phase 3 REGEN-006 trial is ongoing.
The Phase 2 study is open label and small. Only Group 1, the group that matched the Phase 3 schedule, showed a statistically significant change, while the Phase 3 trial compares rilparencel with a sham control.