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ProKidney(PROK) - 2023 Q3 - Earnings Call Transcript
2023-11-16 21:40
ProKidney Corp. (NASDAQ:PROK) Q3 2023 Results Conference Call November 14, 2023 8:00 AM ET Company Participants Dr. Glenn Schulman - SVP of IR Pablo Legorreta - Chairman of Board Dr. Tim Bertram - Co-Founder and Member of Scientific Advisory Board Dr. Bruce Culleton - Chief Executive Officer Conference Call Participants Yigal Nochomovitz - Citi Justin Zelin - BTIG Jonathan Miller - Evercore Jason Gerberry - Bank of America Operator Good morning, ladies and gentlemen, and welcome to the ProKidney Corporate U ...
ProKidney(PROK) - 2023 Q3 - Quarterly Report
2023-11-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40560 ProKidney Corp. (Exact Name of Registrant as Specified in its Charter) | Cayman Islands | 98-1586514 | | --- | --- | | ...
ProKidney(PROK) - 2023 FY - Earnings Call Transcript
2023-09-11 17:15
Financial Data and Key Metrics Changes - The company anticipates having data by 2026 and is planning for commercialization in 2027, with positive interactions with regulators [43][46]. - The current cash balance is sufficient to fund all studies and manufacturing needs, extending the runway into the first half of 2025 [67]. Business Line Data and Key Metrics Changes - The REACT technology is a proprietary method of cell-based therapy targeting chronic kidney disease, with a focus on three key cell types that integrate and promote kidney function [5][11]. - The manufacturing process allows for the production of 5 to 10 doses from a single biopsy, significantly increasing the number of available treatments [16][19]. Market Data and Key Metrics Changes - The addressable market for the targeted patient population is approximately 2.5 million in the U.S., focusing on late-stage chronic kidney disease patients [53]. - The company is observing a renaissance in kidney healthcare, with new therapies being introduced that could impact the standard of care [37]. Company Strategy and Development Direction - The company is moving towards a frozen product formulation for pivotal studies, allowing for injections in both kidneys to maximize therapeutic effect [32][33]. - The strategy includes a focus on sicker patients, as this aligns with payer interests and the potential for extending dialysis-free living [60][55]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for conditional approval based on the regenerative medicine advanced therapy designation, despite the need for two well-controlled trials [44][46]. - The company is actively engaging with payers to understand their needs and is designing trials to demonstrate the value of delaying dialysis [50][55]. Other Important Information - The company is preparing for interim analysis data release by late 2024 or early 2025, depending on event accumulation [39][40]. - A phase one safety trial is underway for patients previously injected with REACT, aiming to explore redosing possibilities [56]. Q&A Session Summary Question: What is the timeline for full data set availability for market filing? - The company anticipates having data by 2026 and is planning for commercialization in 2027, with positive interactions with regulators [43][46]. Question: How is enrollment progressing in the studies? - Enrollment information has not been released, but the company expects interim analysis data around late 2024 or early 2025 [39][40]. Question: What are the differences between the O2 trial and the PROACT studies? - The PROACT studies will use a frozen product, inject both kidneys, and have a blinded control design, differing from the O2 trial [31][34]. Question: What is the addressable patient population for the PROACT studies? - The target population is approximately 2.5 million patients with late-stage chronic kidney disease, which is significant for payers [53]. Question: What are the considerations for pricing and reimbursement? - The company is exploring performance-based pricing models and is working with payers to establish the value proposition of extending dialysis-free living [55].
ProKidney(PROK) - 2023 Q2 - Quarterly Report
2023-08-09 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40560 ProKidney Corp. (Exact Name of Registrant as Specified in its Charter) | Cayman Islands | 98-1586514 | | --- | --- | | ( Sta ...
ProKidney(PROK) - 2023 Q1 - Quarterly Report
2023-05-10 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40560 ProKidney Corp. (Exact Name of Registrant as Specified in its Charter) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 | Cayman Islands | 98-1586514 | | --- | --- | | ( St ...
ProKidney(PROK) - 2022 Q4 - Annual Report
2023-03-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40560 ProKidney Corp. (Exact name of Registrant as specified in its Charter) Cayman Islands 98-1586514 (State or other jurisdiction o ...
ProKidney(PROK) - 2022 Q3 - Quarterly Report
2022-11-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40560 ProKidney Corp. (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1586514 ( State or other juris ...
ProKidney(PROK) - 2022 Q2 - Quarterly Report
2022-08-11 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-40560 PROKIDNEY CORP. (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1586514 (State or ...
ProKidney(PROK) - 2022 Q1 - Quarterly Report
2022-05-15 16:00
Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from to Commission file number: 001-40560 SOCIAL CAPITAL SUVRETTA HOLDINGS CORP. III (Exact Name of Registrant as Specified in Its Charter) Cayman I ...
ProKidney(PROK) - 2021 Q4 - Annual Report
2022-03-23 16:00
For the transition period from to Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (650) 521-9007 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Commission Fil ...