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ProKidney Corp
NASDAQ:PROK

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ProKidney Corp
NASDAQ:PROK
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Price: 2.11 USD 0.48% Market Closed
Market Cap: $634.8m

ProKidney Corp
Investor Relations

ProKidney Corp is a US-based company operating in Biotechnology industry. The company is headquartered in Winston-Salem, North Carolina and currently employs 0 full-time employees. The company went IPO on 2021-06-30. ProKidney Corp., formerly Social Capital Suvretta Holdings Corp. III, is a clinical-stage biotechnology company. The firm is focused on developing a cell therapy platform capable of treating multiple chronic kidney diseases (CKD) using a patient’s own cells isolated from the patient intended for treatment. Its lead product candidate, Renal Autologous Cell Therapy (REACT), is designed to stabilize or improve kidney function in a CKD patient's diseased kidneys. REACT is a product that includes selected renal cells (SRCs) prepared from a patient’s own, autologous, renal cells. The firm is focused on conducting a Phase III development program and multiple Phase II clinical trials for REACT in subjects with moderate to severe diabetic kidney disease.

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Last Earnings Call
Fiscal Period
Q3 2023
Call Date
Nov 14, 2023
AI Summary
Q3 2023

Phase II Data: ProKidney reported promising interim results from its RMCL-002 Phase II trial, showing REACT cell therapy may help preserve kidney function, especially in high-risk stage 4 CKD patients.

Phase III Protocol Change: The company is modifying its proact 1 Phase III trial to focus on sicker CKD patients (eGFR 20–35 ml/min), based on Phase II findings, and increasing enrollment by 600 patients.

Enrollment & Manufacturing Delays: Enrollment in proact 1 and manufacturing are paused to update protocols and address EU regulatory audit issues, with both expected to resume in the first half of 2024.

Safety Profile: REACT therapy continues to show a safety profile similar to kidney biopsy, with no significant treatment-related serious adverse events reported.

Upcoming Catalysts: Final Phase II (002) results and interim data from the 007 trial are expected in the first half and mid-2024, respectively, providing near-term data catalysts.

Financial Position: Management stated the company is well-capitalized into 2025, with several potential financing catalysts ahead.

Key Financials
Patients progressing to dialysis annually (US)
135,000
Average baseline eGFR (active arm, Phase II 002)
33.9 ml/min
Average baseline eGFR (deferred arm, Phase II 002)
31.8 ml/min
Average baseline UACR (active arm, Phase II 002)
740 mg/g
Average baseline UACR (deferred arm, Phase II 002)
598 mg/g
eGFR change (active group, Phase II 002, 30 months)
-3.2 ml
eGFR change (deferred group, standard care, 12 months)
-3.4 ml
eGFR change (deferred group post-REACT, 18 months)
-0.2 ml
Patients with no or minimal eGFR decline (Phase II 002)
27 of 73 (37%)
Average eGFR change (stage 4, high albuminuria, active, 12 months)
-1.6 ml
Average eGFR change (stage 4, high albuminuria, standard care, 12 months)
-6 ml
Proact 1 Phase III planned enrollment increase
600 patients
Proact 1 anticipated enrollment resumption
First half of 2024
Manufacturing resumption
First half of 2024
Proact 1 & 2 anticipated completion
2027
Cash runway
Well capitalized into 2025
Earnings Call Recording
Other Earnings Calls
2023

Management

Dr. Bruce Culleton M.D.
CEO & Director
No Bio Available
Dr. Timothy A. Bertram D.V.M., Ph.D.
Founder
No Bio Available
Mr. James Coulston CPA
Chief Financial Officer
No Bio Available
Mr. Todd C. Girolamo Esq., J.D., M.B.A.
Chief Legal Officer & Secretary
No Bio Available
Dr. Ulrich Ernst Ph.D.
EVP of Science and Technology
No Bio Available
Ms. Carla Poulson
Chief People Officer
No Bio Available
Dr. Joseph M. Stavas M.D., M.P.H.
SVP of Clinical Affairs
No Bio Available
Dr. Darin J. Weber Ph.D.
Chief Reg. Off, SVP and Head of Global Reg. Affairs, Quality Mgmt, Biometrics & Market Access
No Bio Available
Mr. Nikhil L. Pereira-Kamath
Chief Business Officer
No Bio Available
Mr. Richard Williams
Senior Vice President of Information Technology
No Bio Available

Contacts

Address
NORTH CAROLINA
Winston-Salem
3929 Westpoint Blvd., Suite G
Contacts
+13369997029