PROKNasdaqBiological Products, (No Diagnostic Substances)US GAAP · USD

ProKidney Corp

ProKidney Corp. is a U.S.-based clinical-stage biotechnology company focused on developing cell therapies for chronic kidney disease. Its business centers on rilparencel, an autologous renal cell therapy designed to preserve kidney function, along with related manufacturing and clinical development activities in the United States.

Kysy yhtiöstä
Liikevaihto0,9milj. USD
+1 075,0 %v/v
Liikevoitto (EBIT)−165milj. USD
+10,2 %v/v
EBIT-marginaali−18 477,8%
+223 201,1 %-yks.v/v
Nettotulos−69,0milj. USD
−12,7 %v/v
Vapaa kassavirta−135milj. USD
+13,2 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−200−150−100−50050milj. USD2020: EBIT −27 milj. USD20202021: EBIT −55 milj. USD20212022: 0,00 milj. USD2022: EBIT −153 milj. USD20222023: 0,00 milj. USD2023: EBIT −152 milj. USD20232024: 0,08 milj. USD2024: EBIT −184 milj. USD20242025: 0,89 milj. USD2025: EBIT −165 milj. USD20250,89−165
LiikevaihtoLiikevoitto (EBIT)
Kysy Clarifolta: ProKidney Corp

Liiketoiminta

Osuus liikevaihdosta
Cell therapy product candidates0 %

Autologous cell-based therapies under clinical development for kidney disease.

Clinical development services0 %

Research, trial execution, regulatory work, and development activities for rilparencel.

Manufacturing and facility operations0 %

Manufacturing infrastructure and related operational activities supporting the therapy platform.

Lease income100 %

Revenue from leasing activities associated with buildings used in operations.

Asiakkaat

ProKidney does not yet sell a commercial product, so its direct end customers are not established in the traditional sense. Its future customer base is expected to include patients with type 2 diabetes and advanced chronic kidney disease, accessed through physicians, nephrology centers, and healthcare systems if rilparencel is approved. The company also may pursue collaboration or license partners that could pay for development or commercialization rights.

CKD patients

Patients with type 2 diabetes and advanced chronic kidney disease who would receive rilparencel if approved.

Nephrology providers

Physicians and specialty care centers that would identify, refer, and administer therapy pathways.

Strategic partners

Potential collaborators or licensees that could fund development or commercialization.

Property tenants

Counterparties to the company’s lease arrangements tied to its manufacturing-related buildings.

Strategia

ProKidney’s strategy is to advance rilparencel through late-stage clinical development and secure regulatory approval in the United States. It also seeks to maintain manufacturing readiness and preserve optionality through collaborations, licensing, or other strategic transactions while funding development through external capital sources.

Complete clinical development of rilparencelLyhyt aikaväli

Approval depends on demonstrating safety and efficacy in advanced CKD patients.

Secure regulatory approval in the U.S.Lyhyt aikaväli

Commercial value depends on FDA review and acceptance of the clinical package.

Build commercial and manufacturing readinessKeskipitkä aikaväli

A cell therapy requires controlled production, logistics, and quality systems before launch.

Preserve financing flexibilityLyhyt aikaväli

Development-stage biotech requires ongoing external funding before product revenue exists.

Maantiede

ProKidney is headquartered in the United States and conducts its manufacturing operations in Winston-Salem, North Carolina. Its development program is centered on the U.S. market, where it is pursuing regulatory approval for rilparencel. The company also has an international corporate history, but its operating footprint is now primarily U.S.-based.

Riskit

ProKidney faces the typical risks of a clinical-stage biotech company: trial failure, regulatory delay, and the possibility that its product candidate never reaches commercialization. It also depends on external financing and on maintaining manufacturing and quality systems that meet FDA expectations, while its lease-related revenue is limited and not representative of a commercial operating base.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →FDA and regulatory uncertainty2Government and trade policy disruption5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Clinical development failure for rilparencelVaikutus: Kriittinen

    The company’s value depends on positive trial data and eventual approval.

    Kohdistuu: PROACT 1 and REGEN-007

  2. FDA and regulatory uncertaintyVaikutus: KorkeaTodennäköisyys: Korkea

    Approval timing and requirements can change, affecting launch prospects.

    Kohdistuu: U.S. regulatory pathway

  3. Financing and dilution riskVaikutus: Korkea

    The company expects to fund operations through external capital sources.

    KohdistuuEquityDebtGrantsCollaborations
  4. Manufacturing and quality complianceVaikutus: Korkea

    Cell therapy production requires strict controls and regulatory compliance.

    Kohdistuu: Winston-Salem manufacturing operations

  5. Government and trade policy disruptionVaikutus: KeskitasoTodennäköisyys: Korkea

    Changes in tariffs or agency operations can affect supply chains and oversight.

    Kohdistuu: U.S. regulatory and import/export environment

Kysy Clarifolta: ProKidney Corp

Kirjanpito

Harkinnanvaraiset erät
Lease accounting

Revenue now includes lease-related income from acquired buildings, which is separate from product revenue.

Vaikutus: Affects reported revenue and asset utilization

R&D accruals and estimates

Clinical trial, CRO, and regulatory costs require judgment on timing and completeness of accruals.

Vaikutus: Affects operating expense timing

Stock-based compensation

Equity awards and forfeitures can materially affect G&A and R&D expenses.

Vaikutus: Affects non-cash operating expense

Future collaboration revenue

Any licensing or partnership payments would require careful revenue recognition analysis.

Vaikutus: Could change revenue profile materially

Samankaltaisia listattuja yhtiöitä

Julkisesti listattuja yhtiöitä, joilla on samankaltainen liiketoiminta.

Propanc Biopharma, Inc.

PPCB · Pharmaceutical Preparations

Genprex, Inc.

GNPX · Pharmaceutical Preparations

Provectus Biopharmaceuticals, Inc.

PVCT · Pharmaceutical Preparations

Protagenic Therapeutics, Inc.\new

PTIX · Pharmaceutical Preparations

ZyVersa Therapeutics, Inc.

ZVSA · Pharmaceutical Preparations

LeonaBio, Inc.

LONA · Biological Products, (No Diagnostic Substances)

Päivitetty: 24.9.2026