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ProKidney Corp (Nasdaq: PROK) is a leading clinical-stage biotechnology company revolutionizing the treatment of chronic kidney disease (CKD) through its innovative cellular therapy platform. Founded in 2015 after a decade of comprehensive research, ProKidney remains at the forefront of medical advancements aimed at tackling CKD.
The company's flagship product, REACT™ (Renal Autologous Cell Therapy), is a groundbreaking, patented autologous cellular therapy designed to modify the progression of CKD. By utilizing a patient’s own renal cells, REACT™ not only aims to slow and stabilize the disease but also has the potential to significantly improve kidney function in cases reaching stages 3b to 4. This innovative approach has garnered significant attention, earning REACT™ the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and support from both the FDA and EMA for its ongoing Phase 3 clinical trials, which commenced in January 2022.
ProKidney's financial resilience is notable, with nearly $400 million in cash, cash equivalents, and marketable securities as of September 30, 2023. This solid financial foundation is expected to support the company's operations and clinical development initiatives through the fourth quarter of 2025.
Recent milestones include the successful initiation of Phase 3 clinical trials and promising interim data from the Phase 2 REGEN-007 trial, which highlighted REACT™’s potential to preserve kidney function in patients with diabetes-induced CKD. These advancements underscore ProKidney’s commitment to addressing the unmet needs of high-risk CKD patients who face limited treatment options beyond dialysis or transplantation.
The company’s robust pipeline also includes developmental programs targeting severe diabetic kidney disease, reinforcing its leadership position in the biotechnology sector. ProKidney’s strategic partnerships and collaborations, coupled with a dedicated team of experts, continue to drive its mission of bringing life-changing therapies to those affected by chronic kidney disease.
For more information, visit www.prokidney.com.
ProKidney (NASDAQ: PROK) has announced a proposed $125 million public offering of Class A ordinary shares, including an underwritten public offering and a concurrent registered direct offering.
The company is offering all the shares and may grant underwriters a 30-day option to purchase an additional 15% of the shares. Certain investment entities, including those affiliated with ProKidney's chairman, are interested in purchasing shares but have no binding commitments.
Proceeds will be used for clinical trial costs, R&D expenses, and commercial activities. Jefferies, J.P. Morgan, and Guggenheim Securities are joint book-running managers, while PJT Partners acts as co-manager and financial advisor.
ProKidney has announced positive interim results for its Phase 2 REGEN-007 trial focusing on chronic kidney disease (CKD) caused by diabetes. The trial showed stabilization of kidney function over 18 months, with a safety profile consistent with prior studies. The company has resumed manufacturing and restarted its Phase 3 trials PROACT 1 and PROACT 2. Operational updates include resumed patient screening and site activations in Spain. Management will discuss these developments in a live webcast today at 8:00 a.m. ET.
ProKidney, a late clinical-stage cellular therapeutics company specializing in chronic kidney disease (CKD), announced its participation in the Jefferies Global Healthcare Conference. The event is scheduled from June 4 to June 6, 2024, in New York, NY.
Senior management will host one-on-one meetings with investors during the conference. To arrange meetings, investors are advised to contact their Jefferies representative.
ProKidney Corp. (Nasdaq: PROK) is hosting a virtual KOL event on May 28, 2024, to discuss the treatment landscape for chronic kidney disease (CKD) caused by diabetes. The event will feature experts Steven G. Coca and Arnold L. Silva, who will address the unmet medical needs and the importance of preserving kidney function in patients with moderate to severe CKD. The event will also cover final data from the RMCL-002 Phase 2 trial of ProKidney's lead product candidate, rilparencel (REACT®), which will be presented at the European Renal Association (ERA) Congress on May 25, 2024. A live Q&A session will follow the presentations.
ProKidney Corp. reported business updates and financial results for Q1 2024, highlighting upcoming clinical trial data presentations, leadership team enhancements, and financial performance. The Company ended the quarter with $329 million in cash and securities to support operations into Q4 2025. Notably, ProKidney aims to advance its therapeutic options for CKD patients with upcoming Phase 3 trials and a strong focus on preserving kidney function in high-risk populations.