ProKidney Corp. - PROK STOCK NEWS

ProKidney (PROK) reported Q3 2024 financial results and regulatory updates. The FDA confirmed in a Type B meeting that the PROACT 1 Phase 3 study could support full U.S. regulatory approval of rilparencel, and that accelerated approval pathway is available using eGFR slope as a surrogate endpoint. The company ended Q3 with $406.8 million in cash and equivalents, supporting operations into 2027. R&D expenses decreased to $31.3 million from $32.2 million year-over-year, while G&A expenses increased to $17.7 million from $14.4 million. Net loss was $41.1 million, slightly improved from $42.0 million in Q3 2023.

ProKidney Corp (Nasdaq: PROK), a late clinical-stage biotech company developing cell therapy for chronic kidney disease (CKD), announced its participation in two major healthcare conferences this November. The company will present at the Guggenheim Inaugural Healthcare Innovation Conference in Boston on November 13, 2024, at 10:30am ET, and the Jefferies London Healthcare Conference on November 20, 2024, at 10:00am GMT.

Both presentations will be in a fireside chat format, with live webcasts available through ProKidney's website. Replays will be accessible for 90 days after the events. The management team will also conduct one-on-one meetings with investors during both conferences.

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.