PROKIDNEY CORP.
PROK evidence brief
What we can confirm
- BioSniper Score:
- 4.0 / 10
- Market Cap:
- $734.5M
- Lead Asset:
- react (Phase 3)
What it means
What to watch
Prepared research question
What matters most for PROK—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · PROK
PROKIDNEY CORP. (PROK) is a late-clinical-stage biotechnology company developing a first-in-class autologous cell therapy, rilparencel, intended to preserve kidney function in patients with advanced chronic kidney disease (CKD) and type 2 diabetes.
Key risk: Single-product dependency
BioSniper Score
Based on 4 of 6 signals
Market Cap
$734.5M
Cash Runway
—
Lead Asset
react (Phase 3)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 5 clinical trials for PROKIDNEY CORP..
PROKIDNEY CORP. (PROK) is a late-clinical-stage biotechnology company developing a first-in-class autologous cell therapy, rilparencel, intended to preserve kidney function in patients with advanced chronic kidney disease (CKD) and type 2 diabetes.
- Lead product rilparencel (REACT®) is an autologous cell therapy being evaluated in a Phase 3 study (REGEN-006) for advanced CKD and type 2 diabetes [sec_mda · as of 2026-08-10].
- Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA [sec_mda · as of 2026-08-10].
- Completed enrollment of patients contributing to the Phase 3 PROACT 1 accelerated approval efficacy analysis, with pivotal eGFR slope topline results anticipated in Q2 2027 [news · published 2026-08-10].
- Cash and equivalents $74.9M as of 2026-06-30 [sec]; the company expects existing cash to fund operations into mid-2027 [sec_mda · as of 2026-08-10].
- Net income was -$28.4M for the period ending 2026-06-30, and shareholders' equity was -$883.5M [sec].
What works
- Rilparencel has been generally well tolerated in Phase 1 and 2 testing, and has received FDA RMAT designation, which can accelerate development and review [sec_mda · as of 2026-08-10].
- The company has completed enrollment for the PROACT 1 accelerated approval efficacy analysis, positioning it for a potential BLA submission if topline results are positive [news · published 2026-08-10].
- ProKidney ended Q2 2026 with $181.6 million in cash, cash equivalents and marketable securities, providing a runway into mid-2027 [news · published 2026-08-10].
What to weigh
- The company has not yet generated significant revenue ($0.1M as of 2026-06-30) and reported a net loss of $28.4M for the period [sec].
- Shareholders' equity is deeply negative at -$883.5M as of 2026-06-30, indicating accumulated deficits [sec].
- The company's cash runway estimate is based on assumptions that may prove wrong, and expenses are expected to increase substantially as clinical and manufacturing activities ramp up [sec_mda · as of 2026-08-10].
- ProKidney relies on a single lead product candidate (rilparencel); failure in Phase 3 would leave it without a pipeline [sec_mda · as of 2026-08-10].
From the filings
Quoted directly from source documents.
Lead product is rilparencel, an autologous cell therapy for CKD
“ProKidney's lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cell therapy being evaluated in the ongoing Phase 3 REGEN-006”
SEC MD&A · March 18, 2026
Rilparencel has RMAT designation from FDA
“Rilparencel has received regenerative medicine advanced therapy ("RMAT") designation from the United States Food and Drug Administration”
SEC MD&A · August 10, 2026
Cash runway into mid-2027
“We expect that our existing cash, cash equivalents and marketable securities held at June 30, 2026, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.”
SEC MD&A · August 10, 2026
PROACT 1 topline results expected Q2 2027
“Completed enrollment of patients contributing to the Phase 3 PROACT 1 accelerated approval efficacy analysis, positioning the Company for anticipated pivotal eGFR slope topline results in Q2 2027”
News · August 10, 2026
Catalyst timeline
- 2016-09-01 · Phase 2 start (REACT in T2D and CKD) — Initiated a Phase 2 study of renal autologous cell therapy in subjects with type 2 diabetes and chronic kidney disease.
- 2021-07-27 · Phase 2 start (REGEN-007) — Began a Phase 2 study of REACT in subjects with type 1 or 2 diabetes and CKD.
- 2022-01-05 · Phase 3 start (REGEN-006) — Initiated the pivotal Phase 3 randomized controlled study of REACT in subjects with type 2 diabetes and CKD.
Risks & what to watch (4)›
Key risks
- Single-product dependency — ProKidney's entire pipeline rests on rilparencel; failure in Phase 3 would leave no other candidates [sec_mda · as of 2026-08-10].
- Negative equity and net losses — Shareholders' equity -$883.5M and net loss $28.4M as of 2026-06-30 indicate deep accumulated deficits [sec].
- Cash burn and expense escalation — Expenses expected to increase substantially with clinical and manufacturing scale-up; cash runway assumes no unforeseen setbacks [sec_mda · as of 2026-08-10].
- Regulatory uncertainty on surrogate endpoint — Company believes eGFR slope may support accelerated approval, but FDA acceptance is not guaranteed [sec · filed 2026-02-02].
What to watch
- Pivotal eGFR slope topline results from PROACT 1 expected in Q2 2027 [news · published 2026-08-10].
- Completion of full enrollment for PROACT 1 in the second half of 2026 [news · published 2026-08-10].
- Cash burn rate and any updates to the cash runway estimate beyond mid-2027 [sec_mda · as of 2026-08-10].
- Potential BLA submission and FDA feedback on accelerated approval pathway [sec · filed 2026-02-02].
Sources: Catalysts · News · SEC filings · SEC MD&A · Generated October 14, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$28M
Lead: Phase 3
2 candidates
No upcoming catalysts tracked
0 buys · 6 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
69
Total value held
$75.8M
| Holder | Shares | Value |
|---|---|---|
| suvretta capital management, llc | 12,341,266 | $22.1M |
| morgan stanley | 8,955,967 | $16.0M |
| millennium management llc | 2,271,577 | $4.1M |
| bleichroeder lp | 2,000,000 | $3.6M |
| artia global partners lp | 1,806,939 | $3.2M |
| hennion & walsh asset management, inc. | 1,611,693 | $2.9M |
| blackrock, inc. | 1,387,116 | $2.5M |
| renaissance technologies llc | 1,250,794 | $2.2M |
| geode capital management, llc | 1,230,409 | $2.2M |
| vanguard capital management llc | 1,146,937 | $2.1M |
Showing top 10 of 69 institutional holders of PROKIDNEY CORP.. Open the full 13F history after sign-in.
Short Interest
as of Apr 20, 2026- % of float
- 16.1%
- Days to cover
- 21.3
- Shares short
- 16,683,004
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
PROK short interestGovernance
Frequently asked questions
What is the AI investment thesis for PROKIDNEY CORP.?
PROKIDNEY CORP. (PROK) is a late-clinical-stage biotechnology company developing a first-in-class autologous cell therapy, rilparencel, intended to preserve kidney function in patients with advanced chronic kidney disease (CKD) and type 2 diabetes.
What is PROKIDNEY CORP.'s lead drug candidate?
PROKIDNEY CORP.'s most advanced tracked candidate is react (Phase 3) for CKD due to congenital anomalies of the kidney and urinary tract (CAKUT).
Who is the CEO of PROKIDNEY CORP.?
Dr. Bruce Culleton M.D. is the chief executive officer of PROKIDNEY CORP. (PROK).
Where is PROKIDNEY CORP. headquartered?
PROKIDNEY CORP. (PROK) is headquartered in Winston-Salem, NC, United States.
What therapeutic areas does PROKIDNEY CORP. focus on?
PROKIDNEY CORP. develops therapies across Gene Therapy, Metabolic, Nephrology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.