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ProKidney(PROK) - 2025 Q2 - Quarterly Results
2025-08-12 20:20
Exhibit 99.1 ProKidney Reports Second Quarter 2025 Financial Results and Provides Regulatory and Clinical Updates Phase 2 REGEN-007 Positive Topline Results On July 8, 2025, ProKidney announced statistically and clinically significant topline results from the Phase 2 REGEN-007 study. Of note, in Group 1 (n=24), which replicated the rilparencel dosing schedule of the ongoing Phase 3 PROACT 1 study, kidney function stabilized. The annual decline in eGFR slope improved by 78%, from -5.8 in the pre-injection pe ...
ProKidney(PROK) - 2025 Q2 - Quarterly Report
2025-08-12 20:18
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, 2025 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ☐ 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) ( State or other jurisdiction of incorporation or org ...
PROKIDNEY CP (PROK) Upgraded to Strong Buy: What Does It Mean for the Stock?
ZACKS· 2025-07-17 17:01
Core Viewpoint - ProKidney Corp. (PROK) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on an upward trend in earnings estimates [1][2]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with near-term stock price movements [3][5]. - Institutional investors often rely on earnings estimates to determine the fair value of stocks, leading to significant price movements based on their buying or selling actions [3]. Business Improvement Indicators - The upgrade in Zacks Rank for ProKidney Corp. suggests an improvement in the company's underlying business, which is expected to be reflected in higher stock prices [4][9]. - Over the past three months, the Zacks Consensus Estimate for ProKidney has increased by 9.3%, indicating a positive trend in earnings expectations [7]. Zacks Rank System Overview - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [6][8]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, positioning ProKidney in a favorable category for potential market-beating returns [8][9].
Best Momentum Stocks to Buy for July 17th
ZACKS· 2025-07-17 15:01
Group 1: ProKidney Corp. (PROK) - ProKidney is a clinical-stage biotechnology company with a Zacks Rank 1 [1] - The Zacks Consensus Estimate for its current year earnings increased by 5.8% over the last 60 days [1] - ProKidney's shares gained 371.7% over the last three months, significantly outperforming the S&P 500's advance of 18.2% [1] - The company has a Momentum Score of A [1] Group 2: Roku, Inc. (ROKU) - Roku operates a TV streaming platform and holds a Zacks Rank 1 [2] - The Zacks Consensus Estimate for its current year earnings increased by 5.3% over the last 60 days [2] - Roku's shares gained 55.4% over the last three months, also outperforming the S&P 500's advance of 18.2% [2] - The company has a Momentum Score of B [2] Group 3: Pharming Group N.V. (PHAR) - Pharming is a biopharmaceutical company with a Zacks Rank 1 [3] - The Zacks Consensus Estimate for its current year earnings increased nearly 7% over the last 60 days [3] - Pharming's shares gained 26.6% over the last three months, again outperforming the S&P 500's advance of 18.2% [3] - The company has a Momentum Score of B [3]
ProKidney Corp. (PROK) is a Great Momentum Stock: Should You Buy?
ZACKS· 2025-07-16 17:01
Company Overview - ProKidney Corp. (PROK) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook compared to the market [4] Price Performance - Over the past week, PROK shares have surged by 612.49%, significantly outperforming the Zacks Medical - Drugs industry, which increased by 1.75% [6] - In a longer timeframe, PROK's monthly price change is 292.82%, compared to the industry's 1.25% [6] - Over the past quarter, shares of PROK have increased by 349.87%, and they have gained 39.83% in the last year, while the S&P 500 has only moved 16.04% and 12.11%, respectively [7] Trading Volume - The average 20-day trading volume for PROK is 36,681,320 shares, which is a useful indicator of market interest and momentum [8] Earnings Outlook - In the past two months, one earnings estimate for PROK has moved higher, while none have moved lower, resulting in an increase in the consensus estimate from -$0.52 to -$0.49 [10] - For the next fiscal year, one estimate has also moved upwards with no downward revisions during the same period [10] Conclusion - Considering the strong price performance, trading volume, and positive earnings outlook, PROK is positioned as a promising momentum pick with a Momentum Score of A and a Zacks Rank of 2 (Buy) [12]
ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel
Globenewswire· 2025-07-15 11:30
Core Viewpoint - ProKidney Corp. has received confirmation from the FDA regarding the accelerated approval pathway for its autologous cellular therapy, rilparencel, aimed at treating chronic kidney disease (CKD) in patients with type 2 diabetes, marking a significant regulatory milestone for the company [1][3][6] Group 1: FDA Confirmation and Clinical Trials - The FDA confirmed that the estimated glomerular filtration rate (eGFR) slope can serve as a surrogate endpoint for the accelerated approval of rilparencel, with an effect size of at least 1.5 mL/min/1.73m²/year required to demonstrate efficacy [2][6] - ProKidney anticipates topline data readout supporting the accelerated approval application in Q2 2027, with nearly half of the required patients already enrolled in the ongoing Phase 3 PROACT 1 study [2][6] - The ongoing Phase 3 PROACT 1 study may also serve as a confirmatory study for full approval based on the primary time-to-event composite endpoint specified in the protocol [2][6] Group 2: Chronic Kidney Disease Context - Chronic kidney disease (CKD) affects an estimated 37 million adults in the U.S., with diabetes being the leading cause, significantly increasing the risk of cardiovascular events and mortality [4] - ProKidney is focusing on patients with Stage 3b/4 CKD and diabetes, a population estimated to include 1 to 2 million individuals in the U.S., highlighting the substantial unmet need for effective therapies [4] Group 3: ProKidney's Product and Strategy - Rilparencel is a first-in-class, patented autologous cellular therapy developed to preserve kidney function in diabetic patients at high risk of kidney failure [7] - The Phase 3 REGEN-006 (PROACT 1) trial is a randomized, blinded, sham-controlled study with a planned enrollment of approximately 685 subjects, focusing on patients with advanced CKD and type 2 diabetes [5][6]
ProKidney (PROK) FY Conference Transcript
2025-07-14 18:30
Summary of ProKidney (PROK) FY Conference Call - July 14, 2025 Company Overview - ProKidney is a precommercial autologous cell therapy company focused on treating advanced chronic kidney disease (CKD) and type 2 diabetes with a single asset, roperinsel [3][4] - The company went public in 2022 and has since grown to approximately 250 employees [4] Key Developments - Resolved quality audit findings after a manufacturing pause in late 2023 [5] - Restarted phase three clinical study after protocol amendments [5] - Released top-line efficacy and safety data from a phase two study (REGEN 007) [5] Current Therapeutic Landscape for CKD - CKD treatment options include ACE inhibitors, ARBs, SGLT2 inhibitors, nonsteroidal MRAs, and GLP-1 receptor agonists [8] - ProKidney's roperinsel targets patients with advanced CKD (stage 3b and stage 4), where existing therapies have less data [9][10] Mechanism of Action and Study Insights - Roperinsel is expected to preserve kidney function rather than improve it, with a focus on anti-fibrosis and anti-inflammation [15][31] - The REGEN 007 study showed a 78% improvement in the decline of kidney function post-treatment, with a significant reduction in annual decline from -5.8 mL/min to -1.3 mL/min [23][24] Ongoing Clinical Trials - The PROACT 1 trial is designed to enroll over 600 patients with type 2 diabetes and CKD, comparing roperinsel to a sham control [36][39] - The primary endpoint is a composite of significant reductions in eGFR or the need for dialysis or transplant [37] Regulatory and Financial Outlook - A successful FDA meeting is anticipated to confirm eGFR slope as a surrogate endpoint for accelerated approval [45] - ProKidney has a cash balance of $328 million, expected to fund operations into Q2 2027 [46] Manufacturing and Market Expansion - Manufacturing is based in Winston Salem, with current capacity to support phase three trials and initial commercial launch [47] - Future expansion into international markets is considered, but the primary focus remains on the U.S. market [48] Upcoming Catalysts - Updates on the type B FDA meeting and full results from the REGEN 007 study are expected soon, with significant presentations anticipated at the American Society of Nephrology meeting [50]
PROK Surges More Than 500% on Upbeat Data From Kidney Cell Therapy Study
ZACKS· 2025-07-09 17:31
Core Insights - ProKidney Corp. (PROK) shares surged 515% following positive phase II REGEN-007 study results for its drug rilparencel, aimed at treating diabetes and chronic kidney disease (CKD) [1][6] - The study demonstrated a statistically significant improvement in kidney function decline in one dosing group, with a 78% improvement in eGFR slope for Group 1 [3][6] Study Results - The REGEN-007 study randomized patients into two groups: Group 1 received two injections of rilparencel, while Group 2 received a single dose with a second only if kidney function declined [2] - The primary endpoint was the difference in annual estimated glomerular filtration rate (eGFR) slope, showing a 78% improvement in Group 1 and a 50% reduction in Group 2, although the latter did not reach statistical significance [3][6] Regulatory Outlook - ProKidney plans to seek FDA confirmation of eGFR slope as a surrogate endpoint in its ongoing Phase III trial, which could support accelerated approval based on the study results [7][8] - The company is scheduled to meet with the FDA to discuss the use of eGFR slope as the primary surrogate endpoint in the PROACT 1 study [8] Market Performance - Year-to-date, ProKidney's stock has increased by 121%, significantly outperforming the industry average growth of 4% [4] - The recent study results have raised the probability of success for rilparencel, contributing to the stock's dramatic increase [9] Company Ranking - ProKidney currently holds a Zacks Rank of 2 (Buy), indicating positive market sentiment [10]
ProKidney: What's Happening With PROK Stock?
Forbes· 2025-07-09 12:45
Core Viewpoint - ProKidney Corp. has experienced significant stock volatility following positive Phase 2 clinical trial results for its REGEN-007 study, which shows promise for treating chronic kidney disease (CKD) and diabetes [2][5]. Group 1: Clinical Trial Outcomes - The Phase 2 trial results indicated a 78% improvement in the annual decline of estimated glomerular filtration rate (eGFR) for Group 1 participants who received two rilparencel injections [6]. - Group 2 participants, who received a single injection with a conditional second injection, showed a 50% improvement in annual eGFR decline, although this result was not statistically significant [6]. - These findings represent a significant clinical milestone, as CKD affects millions globally and treatment options are limited [2]. Group 2: Market Response and Stock Performance - Following the positive trial results, ProKidney's stock surged over 500% on July 8, although it remains over 70% below its 2023 peak of approximately $13 [2]. - Current analyst consensus price targets are around $4.00, suggesting the stock may be fairly valued at its current levels [3]. Group 3: Financial Position - ProKidney holds a robust cash balance of $358 million, representing 81% of its total assets, and has a minimal debt load of $3.2 million, resulting in a debt-to-equity ratio below 1% [3]. - The company incurred operating expenditures totaling $185 million over the past year and has no commercial products generating revenue, necessitating continuous observation of its cash burn rate [4]. Group 4: Risks and Challenges - The uncertainty surrounding the Phase 3 trial poses a significant risk, as success in Phase 2 does not guarantee success in subsequent phases or regulatory approvals [5]. - ProKidney faces competitive risks from other companies developing therapies for CKD and has a limited pipeline reliant on rilparencel, which adds to its risk profile [5]. - The stock has shown substantial price fluctuations, with a notable decline of 91% from a high of $13.78 on March 13, 2023, to $1.21 on November 17, 2023 [5].
ProKidney to Participate in the H.C. Wainwright 4th Annual Kidney Virtual Conference
Globenewswire· 2025-07-09 11:30
Core Viewpoint - ProKidney Corp. is actively engaging with investors through participation in the H.C. Wainwright 4 Annual Kidney Virtual Conference, highlighting its focus on chronic kidney disease and its innovative cellular therapy approach [1]. Company Overview - ProKidney Corp. is a pioneer in chronic kidney disease treatment through cellular therapy innovations, founded in 2015 after a decade of research [2]. - The company's lead product candidate, rilparencel (REACT), is a first-in-class autologous cellular therapy currently in Phase 2 and Phase 3 studies aimed at preserving kidney function in diabetic patients at high risk of kidney failure [2]. - Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating its potential significance in the treatment landscape [2].