WINSTON-SALEM, N.C. - ProKidney Corp. (NASDAQ: PROK), a cellular therapeutics company, announced interim results from its Phase 2 REGEN-007 trial, which show stabilization of kidney function in patients with chronic kidney disease (CKD) caused by diabetes. The trial is testing the company's renal autologous cell therapy, rilparencel.
In the trial, patients with CKD and an estimated glomerular filtration rate (eGFR) of 20 - 50 mL/min/1.73m² were divided into two groups. Group 1 followed a dosing schedule similar to the ongoing Phase 3 studies, receiving two injections of rilparencel three months apart, one in each kidney.
Group 2 is exploring an alternative dosing regimen where a second dose is administered based on specific physiological triggers. Twenty-five patients received at least one rilparencel injection, and 12 received a second dose based on either eGFR or urine albumin to creatinine ratio (UACR) criteria. No serious adverse events related to rilparencel were observed among patients who received at least one injection.
ProKidney has resumed manufacturing for its clinical study sites and anticipates a potential Quality Person (QP) Declaration of Equivalence to European Union Good Manufacturing Practices (EU GMPs) by the end of June 2024. This would enable the shipment of rilparencel to European clinical study sites. The company has also resumed screening patients under an amended protocol for its PROACT 1 study and activated sites in Spain for its PROACT 2 study.
Bruce Culleton, CEO of ProKidney, expressed optimism about the interim results and the potential of rilparencel to preserve kidney function in a patient population with limited treatment options. The company is preparing for the next phase of its evolution as it aims to demonstrate the efficacy of rilparencel in a larger patient population through its Phase 3 studies.
The information reported is based on a press release statement from ProKidney.
In other recent news, ProKidney Corp. has been the subject of several significant developments. Earnings and revenue forecasts for the company's cell therapy drug, REACT, have been revised upwards by BofA Securities due to new data suggesting increased market potential. The firm now expects peak sales for REACT to reach $1.8 billion, up from the previous estimate of $1.5 billion.
In further news, ProKidney's REACT holds a Buy rating and a $6.00 price target from BTIG, which emphasizes the drug's potential in treating severe diabetic chronic kidney disease. The rating follows a call with key opinion leaders, discussing REACT's unique mechanism and its potential to preserve kidney function in patients inadequately managed by existing therapies.
Analyst firm BTIG also anticipates positive outcomes from the Phase 2 REGEN-007 study, which will support the success of the subsequent Phase 3 PROACT 1 & 2 studies.
In addition, ProKidney Corp. has expanded its executive team with two key appointments aimed at advancing its Phase 3 clinical program and preparing for future product commercialization. The new appointees bring extensive experience in the biopharmaceutical industry and clinical trial execution, which is expected to significantly contribute to the company's late-stage clinical program.
InvestingPro Insights
As ProKidney Corp. (NASDAQ: PROK) advances its clinical trials with promising results, investors are keeping a close eye on the company's financial health and market performance. According to InvestingPro data, ProKidney's market capitalization stands at a modest $203.92 million. Despite the challenges faced by the company, including a negative P/E ratio of -5.88 reflecting the company's current lack of profitability, there have been significant positive movements in the stock price. Over the last three months, the price total return reached an impressive 91.59%, coupled with a solid one-month price return of 13.52%.
Delving into the company's financial position, an InvestingPro Tip highlights that ProKidney holds more cash than debt on its balance sheet, which is a reassuring sign for investors concerned about the company's ability to fund its operations. Additionally, another InvestingPro Tip points out that management has been actively buying back shares, signaling confidence in the company's future prospects.
While ProKidney's journey towards profitability is ongoing, with analysts not expecting the company to be profitable this year, the company's strategic moves and the interim clinical results may offer a silver lining. For those interested in a deeper dive into ProKidney's potential and to access more expert analysis, InvestingPro offers more tips. In fact, there are 12 additional InvestingPro Tips available for ProKidney at https://www.investing.com/pro/PROK, which could provide valuable insights for investors considering this stock. Remember to use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, enriching your investment strategy with expert guidance.
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