Machine learning predictions based on historical earnings data and price patterns
1-Day Prediction
+3.13%
$1.74
100% positive prob.
5-Day Prediction
+15.03%
$1.94
100% positive prob.
20-Day Prediction
+19.13%
$2.01
95% positive prob.
| Quarter | Signal | 1D Return | 5D Return | 20D Return | Confidence | Actual 5D |
|---|---|---|---|---|---|---|
| Q2 2026 | BUY | +3.13% | +15.03% | +19.13% | 100.0% | Pending |
| Q1 2026 | SELL | -1.36% | -12.99% | -18.03% | 100.0% | +4.18% |
| Q3 2025 | SELL | -1.42% | -12.10% | -21.92% | 100.0% | -16.67% |
SEC 8-K filings with transcript text
Aug 10, 2026 · 100% conf.
1D
+3.13%
$1.74
Act: -4.73%
5D
+15.03%
$1.94
20D
+19.13%
$2.01
2 prok-ex99_1.htm
Exhibit 99.1
ProKidney Reports Second Quarter 2026 Financial Results and Business Highlights
• 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
• On track for completion of full enrollment for PROACT 1 in the second half of 2026
• Appointed Kenneth Locke as Chief Technical Officer, adding more than 25 years of R&D, CMC and supply chain leadership experience
• Ended Q2 2026 with $181.6 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027
WINSTON-SALEM, N.C., August 10, 2026 – ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today reported financial results for the second quarter ended June 30, 2026, and provided business highlights.
“This update marks an important milestone for ProKidney as we have completed enrollment for the PROACT 1 accelerated approval analysis, positioning us for our pivotal eGFR slope topline readout anticipated in the second quarter of 2027,” said Bruce Culleton, M.D., CEO of ProKidney. “We also remain on track to complete full enrollment for PROACT 1 in the second half of this year and recently strengthened our leadership team with the appointment of Ken Locke as Chief Technical Officer, adding deep manufacturing and supply chain expertise as we prepare for future regulatory and commercial milestones. Our focus remains on advancing rilparencel as a potential new treatment option for patients with advanced CKD and type 2 diabetes who are at high risk of kidney failure, an area of significant unmet medical need.”
Business Highlights
Phase 3 REGEN-006 (PROACT 1) Study
• Completed enrollment of patients contributing to the accelerated approval efficacy analysis, which is expected to include approximately 320 patients and evaluate annualized eGFR slope as the surrogate endpoint; topline results are anticipated in Q2 2027
• On track to complete full enrollment of approximately 470 patients in the second half of 2026 for the confirmatory composite time-to-event analysis; topline results anticipated in the second half of 2029
Leadership Update
In June 2026, ProKidney appointed Kenneth Locke as Chief Technical Officer. Mr. Locke brings more than 25 years of experience across R&D, Chemistry, Manufacturing, and Controls (CMC) and Supply Chain. Most recently, he served as Senior Vice President of Technical Operations at Carisma Therapeutics, where he oversaw CMC, Quality, and Regulatory functions and led technical strategy for first-in-human CAR Myeloid programs. Prior to Carisma, he held leadership roles at Celgene (now Bristol Myers Squibb), where he led external manufacturing and strategic sourcing for cell therapy programs, and at Novartis,
where he helped advance early-stage cell therapy programs and established global capabilities across manufacturing and supply chain.
Second Quarter 2026 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of June 30, 2026, totaled $181.6 million, compared to $224.9 million as of March 31, 2026.
R&D Expenses: Research and development expenses were $36.1 million for the three months ended June 30, 2026, compared to $25.9 million for the same period in 2025. The increase of $10.2 million was driven by increases in clinical study and related manufacturing costs of $8.7 million, primarily related to our ongoing PROACT 1 study. Additionally, research costs related to our ongoing mechanism of action studies and other professional fees increased $0.6 million and $0.4 million, respectively.
G&A Expenses: General and administrative expenses were $12.4 million for the three months ended June 30, 2026, compared to $14.0 million for the same period in 2025. The decrease of $1.6 million was driven primarily by decreases in compensation costs of approximately $1.2 million due to vesting of awards issued prior to our business combination in 2022, coupled with forfeitures of equity-based awards and reductions in severance costs. Additionally, professional fees and other operating costs decreased $0.4 million driven by ongoing initiatives, including the domestication and restructuring transactions in 2025.
Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $46.4 million and $37.0 million for the three months ended June 30, 2026 and 2025, respectively.
Shares Outstanding: Class A and Class B common stock outstanding at June 30, 2026, totaled 302,312,504 shares.
About Chronic Kidney Disease
CKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD), requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undi
May 15, 2026 · 100% conf.
1D
-1.36%
$1.65
Act: -3.88%
5D
-12.99%
$1.46
Act: +4.18%
20D
-18.03%
$1.37
2 prok-ex99_1.htm
Exhibit 99.1
ProKidney Reports First Quarter 2026 Financial Results and Business Highlights
• On track to complete enrollment for the Phase 3 PROACT 1 accelerated approval analysis of rilparencel in mid-2026; anticipate pivotal topline results in Q2 2027
• Peer-reviewed results from the Phase 2 REGEN-007 study were published in the Clinical Journal of the American Society of Nephrology (CJASN) in January 2026
• Ended Q1 2026 with $224.9 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027
WINSTON-SALEM, N.C., May 15, 2026 – ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today reported financial results for the first quarter ended March 31, 2026, and provided business highlights.
“As we progress through 2026, we continue to build on the momentum established last year through positive Phase 2 REGEN-007 results, alignment with the FDA on the accelerated approval pathway, and meaningful progress on Phase 3 PROACT 1 study enrollment,” said Bruce Culleton, M.D., CEO of ProKidney. “We expect to complete enrollment in PROACT 1 this year, positioning us to deliver pivotal eGFR slope topline results in the second quarter of 2027. Our mission remains highly focused on advancing a potential new treatment option for patients with advanced CKD and diabetes at high risk of kidney failure, an area of significant unmet medical need.”
Business Highlights
Phase 3 REGEN-006 (PROACT 1) — Pivotal Study
• Enrollment: On track to complete enrollment for the surrogate (eGFR slope) endpoint in mid-2026
• Topline readout: Pivotal results expected in Q2 2027
• Study Power
• 90% power to detect an effect size of 1.75 mL/min/1.73m² in annualized eGFR slope
• 80% power to detect an effect size of 1.5 mL/min/1.73m² in annualized eGFR slope
• FDA Alignment: Under rilparencel’s regenerative medicine advanced therapy (RMAT) designation, the U.S. Food and Drug Administration (FDA) confirmed in a prior Type B meeting that a rilparencel effect size of 1.5 mL/min/1.73m² per year would be an acceptable demonstration of efficacy in patients receiving appropriate standard of care
• Phase 2 REGEN-007 Data: In Group 1, bilateral kidney injections with rilparencel were associated with a 4.6 mL/min/1.73m² improvement in the annual decline in eGFR slope in the pre-injection period versus the period after the last rilparencel injection
Regulatory Position
• July 2025 Type B meeting: FDA confirmed that eGFR slope in patients from the ongoing PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission under the accelerated approval pathway
• FDA also confirmed that PROACT 1 may be used to support both accelerated and confirmatory approval of rilparencel
• ProKidney continues to maintain its ongoing dialogue with the FDA under rilparencel’s RMAT designation
Publications & Presentations
• January 2026: Phase 2 REGEN-007 results published in the Clinical Journal of the American Society of Nephrology (CJASN)
• November 2025: Phase 2 REGEN-007 results presented as a late-breaking clinical trial at ASN Kidney Week
Key Clinical Takeaway
The Company has achieved FDA alignment on the accelerated and confirmatory approval pathways for rilparencel. Completion of PROACT 1 enrollment this year is a key 2026 milestone. The positive Phase 2 REGEN-007 results provide confidence heading into the expected pivotal topline results (eGFR slope) in the second quarter of 2027.
First Quarter 2026 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of March 31, 2026, totaled $224.9 million, compared to $270.0 million as of December 31, 2025. We expect that our existing cash, cash equivalents and marketable securities held at March 31, 2026, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.
R&D Expenses: Research and development expenses were $33.8 million for the three months ended March 31, 2026, compared to $27.3 million for the same period in 2025. The increase of $6.6 million was driven primarily by increases in clinical study and related manufacturing costs of $6.5 million related to our ongoing PROACT 1 study. Additionally, compensation costs increased $1.2 million related to the hiring of additional personnel to support our operations. These increases have been offset by decreases in costs of $1.6 million related to clinical study costs for trials that have been completed or terminated.
G&A Expenses: General and administrative expenses were $11.3 million for the three months ended March 31, 2026 compared to $14.4 million for the same period in 2025. The decrease of $3.1 million was driven primarily by decreases in compensation costs of approximately $1.7 million due to vesting of awards issued prior to the busin
Mar 18, 2026
2 prok-ex99_1.htm
Exhibit 99.1
ProKidney Reports Full Year 2025 Financial Results and Business Highlights
• On track to complete enrollment for the Phase 3 PROACT 1 accelerated approval analysis of rilparencel in mid-2026; anticipate pivotal topline results in Q2 2027
• In a July 2025 Type B meeting, aligned with FDA on the accelerated approval pathway for rilparencel using eGFR slope as the surrogate endpoint
• Presented positive results from the Phase 2 REGEN-007 study of rilparencel as a late-breaking clinical trial at ASN Kidney Week 2025 followed by a peer-reviewed publication in CJASN
• Ended 2025 with $270.0 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027
WINSTON-SALEM, N.C., March 18, 2026 – ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today reported financial results for the full year ended December 31, 2025, and provided business highlights.
“2025 was a pivotal year for ProKidney, highlighted by positive Phase 2 REGEN-007 study results, alignment with the FDA on the accelerated approval pathway for rilparencel, and significant enrollment momentum in the Phase 3 PROACT 1 study,” said Bruce Culleton, M.D., CEO of ProKidney. “Looking ahead, we are well positioned to deliver on key upcoming milestones, including completion of enrollment for the Phase 3 PROACT 1 study this year followed by pivotal eGFR slope data in the second quarter of 2027. Our mission remains highly focused on bringing a potential new treatment option to patients with advanced CKD and diabetes at high risk of kidney failure – an area of high unmet medical need.”
Key Accomplishments in 2025
• Generated significant enrollment momentum in the Phase 3 PROACT 1 study, positioning the Company for a pivotal topline readout in Q2 2027 using eGFR slope.
• Confirmed with the U.S. Food and Drug Administration (FDA) in a July 2025 Type B meeting that eGFR slope in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission of rilparencel under the accelerated approval pathway. FDA also confirmed that PROACT 1 may be used to support both accelerated and confirmatory approval of rilparencel. ProKidney continues to maintain its ongoing dialogue with the FDA under rilparencel’s regenerative medicine advanced therapy (RMAT) designation.
• Presented positive results from the Phase 2 REGEN-007 study of rilparencel in patients with advanced CKD and diabetes as a late-breaking clinical trial at the American Society of Nephrology (ASN) Kidney Week in November 2025, followed by a peer-reviewed publication in the Clinical Journal of the American Society of Nephrology (CJASN).
• Initiated expansion of in-house manufacturing footprint in two adjacent, company-owned facilities totaling 180,000 square feet in Winston-Salem, NC.
Anticipated Upcoming Milestones
• Mid-2026: Complete enrollment of patients to be included in the Phase 3 PROACT 1 accelerated approval efficacy analysis (n=~360)
• 2H 2026: Complete full enrollment for Phase 3 PROACT 1 confirmatory composite time-to-event analysis (n=~470)
• Throughout FY 2026: Present results from ongoing mechanism of action studies of rilparencel at medical and scientific conferences
• Q2 2027: Phase 3 PROACT 1 readout of surrogate endpoint (eGFR slope) for accelerated approval
• Q4 2027: BLA submission of rilparencel
• 2H 2028: BLA approval and commercial launch of rilparencel
• 2H 2029: Phase 3 PROACT 1 topline readout of confirmatory endpoint (composite time-to-event) for full approval
Full Year 2025 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of December 31, 2025, totaled $270.0 million, compared to $358.3 million as of December 31, 2024. We expect that our existing cash, cash equivalents and marketable securities held at December 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.
R&D Expenses: Research and development expenses were $114.1 million for the year ended December 31, 2025, compared to $127.7 million for the year ended December 31, 2024. The decrease of $13.5 million was driven primarily by decreases in clinical study costs of $18.1 million from our clinical trials that have been completed or terminated. Additionally, operating costs have decreased $3.3 million related to the recognition of costs related to the remediation of quality management systems and processes in the 2024 period. These decreases have been offset by increases in cash and equity based compensation costs of approximately $5.5 million as we continue to hire additional personnel in the areas of clinical development, quality, manufacturing, and biostatistics to support our ongoing clinical trials. Also, clinical trial costs have increased
This page provides ProKidney Corp. (PROK) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.
Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on PROK's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.