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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 Corp. (Nasdaq: PROK), a late clinical-stage biotech company focusing on developing a first-in-class cell therapy for chronic kidney disease (CKD), has announced its participation in the UBS Virtual Organ Restoration Day on October 15, 2024. Senior management team members will engage in a fireside chat at 9:00am ET.
The event will be accessible via a live webcast, with a link provided for public viewing. Additionally, the webcast will be available through ProKidney's website in the 'Events' section of the Investor Relations tab. A replay will remain accessible for 90 days following the event.
ProKidney's management team will also conduct one-on-one meetings with investors during the event. Interested parties are advised to contact their UBS representative to arrange these meetings.
ProKidney Corp. (Nasdaq: PROK) has announced strategic updates to its Phase 3 program for rilparencel, a potential treatment for chronic kidney disease (CKD) in patients with type 2 diabetes. The company has decided to discontinue the ex-U.S.-based PROACT 2 trial and focus resources on PROACT 1 to accelerate enrollment and data readout, now estimated for Q3 2027. This decision follows a comprehensive review and engagement with regulatory experts.
ProKidney believes rilparencel is eligible for initial FDA approval under an expedited pathway based on the PROACT 1 trial, leveraging its Regenerative Medicine Advanced Therapy (RMAT) designation. This strategic shift is expected to reduce expenses by $150-$175 million and extend the company's cash runway into Q1 2027. The company aims to prioritize the U.S. market, where there is high unmet clinical and economic need for advanced CKD treatments.
ProKidney Corp. (Nasdaq: PROK), a leading late clinical-stage biotech company focused on developing a first-in-class cell therapy for chronic kidney disease (CKD), has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will take place in New York, NY from September 4-6, 2024.
Key details:
- Date: Thursday, September 5, 2024
- Time: 7:00 a.m. ET
- Format: Fireside Chat
A live webcast will be available through the company's website, with a 90-day replay option after the event. ProKidney's management team will also host one-on-one meetings with interested investors during the conference.
ProKidney Corp. (PROK) reported Q2 2024 financial results and business updates. Key highlights include:
1. Presented interim REGEN-007 data showing kidney function stabilization in diabetes and advanced CKD patients.
2. Restarted manufacturing and resumed PROACT 1 and PROACT 2 Phase 3 trials.
3. Closed a $140 million upsized public offering, extending cash runway into mid-2026.
4. Ended Q2 with $431.5 million in cash and equivalents.
5. R&D expenses increased to $29.4 million, up from $26.4 million in Q2 2023.
6. G&A expenses slightly increased to $13.7 million from $13.5 million in Q2 2023.
7. Net loss before noncontrolling interest was $38.5 million, compared to $34.8 million in Q2 2023.
8. Appointed Carla Poulson as Chief People Officer.
ProKidney has successfully closed a $140 million public and direct offering of Class A shares. The company sold 46,886,452 shares in the public offering at $2.42 each, including an additional 4,142,232 shares via underwriters' options, and 11,030,574 shares in the direct offering at the same price. The funds will support clinical trials, research, development, commercial activities, and general corporate purposes. CEO Bruce Culleton highlighted that the proceeds extend their cash runway to mid-2026 and aid in the development of rilparencel for chronic kidney disease. Jefferies, J.P. Morgan, Guggenheim Securities, and PJT Partners facilitated the offering.
ProKidney, a late clinical-stage cellular therapeutics company focused on chronic kidney disease, announced the pricing of its upsized $130 million public offering of Class A ordinary shares. The offering consists of 53,719,009 shares at $2.42 per share, with an option for underwriters to purchase an additional 15% within 30 days. The public and registered direct offerings are expected to close around June 13, 2024, subject to customary conditions.
Proceeds will fund clinical trial costs, research and development, pre-commercial and commercial activities, and general corporate purposes. Jefferies, J.P. Morgan, and Guggenheim Securities are managing the underwritten public offering, with PJT Partners serving as co-manager and financial advisor.
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.
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