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PROKNasdaq

PROKIDNEY CORP.

Biopharma developer (SEC filing verified)·Phase 3·Winston-Salem, NC, United States·CEO: Dr. Bruce Culleton M.D.
Gene TherapyMetabolicNephrology

PROK evidence brief

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Prepared research question

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BioSniper AI · PROK

ProKidney Corp. is a clinical-stage biotechnology company developing rilparencel, a renal autologous cell therapy for chronic kidney disease, with a Phase 3 trial underway and cash runway into mid-2027.

Key risk: Clinical trial failure

3.1/10

BioSniper Score

Based on 6 of 6 signals

Market Cap

$730.5M

Cash Runway

8.1 mo

Lead Asset

react (Phase 3)

Financial data as of Jun 30, 2026.

Tracking 2 pipeline candidates · 4 clinical trials · 1 catalyst for PROKIDNEY CORP..

AI OverviewAI overview is shown in English only.

ProKidney Corp. is a clinical-stage biotechnology company developing rilparencel, a renal autologous cell therapy for chronic kidney disease, with a Phase 3 trial underway and cash runway into mid-2027.

  • ProKidney's lead product candidate is rilparencel, a renal autologous cell therapy (REACT) being evaluated in a Phase 3 randomized controlled trial for type 2 diabetes patients with chronic kidney disease [sec_mda · as of 2026-08-10].
  • As of June 30, 2026, the company reported cash and equivalents of $74.9 million, with an additional $175.0 million available under a sales agreement [sec_mda · as of 2026-08-10].
  • The company expects existing cash to fund operations into mid-2027, but notes this estimate could change and it may exhaust capital sooner [sec_mda · as of 2026-08-10].
  • ProKidney has an accumulated deficit of $1,011.2 million in shareholders' equity as of June 30, 2026, reflecting years of R&D spending without product revenue [sec].
  • The company has completed two Phase 2 trials of rilparencel (NCT02836574 and NCT05018416) and is now focused on the Phase 3 PROACT-1 trial [catalyst].

What works

  • ProKidney has a clear regulatory pathway: the FDA has indicated that the Phase 3 PROACT-1 trial alone could support a BLA submission and full approval, with eGFR slope as a surrogate endpoint for accelerated approval [sec · filed 2024-09-03].
  • The company has a substantial cash position ($74.9M as of June 30, 2026) plus a $175.0M at-the-market facility, providing financial flexibility to advance its pivotal trial [sec_mda · as of 2026-08-10].
  • Rilparencel targets a large unmet need in chronic kidney disease, with prior Phase 2 data showing improvement in renal function progression rate [catalyst].

What to weigh

  • ProKidney has no approved products and has never generated material revenue from product sales; it is entirely dependent on the success of rilparencel [sec_mda · as of 2026-08-10].
  • The company's accumulated deficit is $1,011.2 million as of June 30, 2026, and it expects expenses to increase substantially as clinical trials progress [sec].
  • Cash runway is only projected into mid-2027, and the company acknowledges it could exhaust capital sooner than expected if assumptions prove wrong [sec_mda · as of 2026-08-10].
  • The Phase 3 trial is still ongoing and there is no guarantee of positive topline results or eventual regulatory approval [sec_mda · as of 2026-08-10].

From the filings

Quoted directly from source documents.

  • ProKidney expects cash to fund operations 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

  • The FDA has indicated that the Phase 3 PROACT-1 trial could be sufficient for BLA submission.

    the Company's beliefs that its PROACT 1 trial could be sufficient to support a potential BLA submission and full regulatory approval, eGFR slope can be used as a surrogate endpoint on an accelerated approval pathway for rilparencel

    SEC filings · September 3, 2024

  • There is $175.0 million remaining available under the 2025 Sales Agreement.

    As of June 30, 2026, there was approximately $175.0 million remaining available to be sold under the 2025 Sales Agreement.

    SEC MD&A · August 10, 2026

Catalyst timeline

  • 2029-12-01 · Phase3_ToplineTopline results from the Phase 3 randomized controlled study of REACT in subjects with type 2 diabetes and chronic kidney disease.
Risks & what to watch (4)

Key risks

  • Clinical trial failureThe Phase 3 PROACT-1 trial may not meet its primary endpoint, delaying or preventing approval [sec_mda · as of 2026-08-10].
  • Cash runway uncertaintyCash runway is only into mid-2027; the company may need additional financing, which could be dilutive [sec_mda · as of 2026-08-10].
  • Regulatory dependencyApproval relies on FDA acceptance of eGFR slope as a surrogate endpoint; any change could derail the pathway [sec · filed 2024-09-03].
  • Single product focusProKidney has only one product candidate in development, increasing business risk if it fails [sec_mda · as of 2026-08-10].

What to watch

  • Topline data from the Phase 3 PROACT-1 trial, expected by Q3 2027 per prior guidance [sec · filed 2024-09-03].
  • Cash burn rate and any future capital raises or use of the $175.0M ATM facility [sec_mda · as of 2026-08-10].
  • Regulatory updates from the FDA regarding the accelerated approval pathway for rilparencel [sec · filed 2024-09-03].
  • Any partnership or licensing deals to expand the pipeline or reduce financial risk [sec_mda · as of 2026-08-10].

Sources: Catalysts · SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 6 of 6 signals · derived from public data

Cash Runway2.3

8.1 months

Financial Health0.5

OCF -$40M · Net income -$28M

Pipeline Maturity8.5

Lead: Phase 3

Pipeline Breadth4.6

2 candidates

Catalyst Momentum2.0

1 upcoming, next in ~1189d

Insider Signal0.8

0 buys · 6 sells (180d)

Runway

Catalysts

Pipeline

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

67

Total value held

$69.2M

HolderSharesValue
suvretta capital management, llc12,341,266$22.1M
morgan stanley8,955,967$16.0M
vanguard capital management llc2,293,874$4.1M
millennium management llc2,271,577$4.1M
blackrock, inc.1,387,116$2.5M
renaissance technologies llc1,250,794$2.2M
geode capital management, llc1,230,409$2.2M
marshall wace, llp1,011,744$1.8M
woodline partners lp1,000,000$1.8M
bank of america corp /de/753,412$1.3M

Showing top 10 of 67 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 interest

Governance

Frequently asked questions

What is the AI investment thesis for PROKIDNEY CORP.?

ProKidney Corp. is a clinical-stage biotechnology company developing rilparencel, a renal autologous cell therapy for chronic kidney disease, with a Phase 3 trial underway and cash runway into mid-2027.

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).

What is PROKIDNEY CORP.'s next catalyst?

PROKIDNEY CORP.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type" — expected December 1, 2029.

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.

925 companies232,681 SEC filings21,419 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.