ProKidney(PROK) - 2025 Q1 - Quarterly Results

ProKidney Q1 2025 Financial Results and Business Highlights ProKidney reports its Q1 2025 financial results, highlighting a strong cash position, key clinical milestones for rilparencel, and detailed financial statements Business and Financial Highlights ProKidney reported a strong financial position with a cash runway into mid-2027, anticipating key milestones including Phase 2 REGEN-007 data and an FDA regulatory update for rilparencel, while managing stable operating expenses - The company anticipates two major upcoming catalysts: the release of full data from the Phase 2 REGEN-007 study's Group 1 in Q2 2025 and an update on the accelerated approval pathway for rilparencel after a planned Type B FDA meeting in mid-2025[2][6] Q1 2025 Financial Position | Indicator | Value (as of March 31, 2025) | | :--- | :--- | | Cash, cash equivalents and marketable securities | $328.5 million | | Expected Cash Runway | Into mid-2027 | Quarterly Expense Comparison (in millions) | Expense Category | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | R&D Expenses | $27.3 | $27.2 | Increased compensation and facility costs offset by lower clinical trial and professional fees | | G&A Expenses | $14.4 | $12.8 | Increased cash compensation and professional fees, partially offset by lower equity-based compensation | Net Loss and Share Information | Indicator | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss Before Noncontrolling Interest | $38.0 million | $35.3 million | | Class A and Class B Shares Outstanding | 292,697,802 | N/A | Clinical Trial Updates ProKidney is advancing two key clinical trials for rilparencel, including the Phase 3 PROACT 1 study for advanced CKD and the Phase 2 REGEN-007 trial evaluating different dosing regimens - The Phase 3 REGEN-006 (PROACT 1) trial is a randomized, sham-controlled study enrolling approximately 685 subjects with stage 4 or late stage 3b CKD, with its primary composite endpoint measuring time to a 40% reduction in eGFR, kidney failure, or renal/cardiovascular death[10] - The Phase 2 REGEN-007 trial is an open-label study with two arms testing different dosing regimens, where Group 1 receives two injections three months apart mirroring the Phase 3 study, and Group 2 tests an exploratory regimen where the second dose is triggered by a sustained decline in kidney function[11][12] Financial Statements This section provides a detailed overview of ProKidney's consolidated financial position, operating performance, and cash flow activities for the first quarter of 2025 Consolidated Balance Sheets ProKidney's total assets decreased to $406.1 million as of March 31, 2025, primarily due to reduced cash and marketable securities, while total liabilities also slightly decreased Key Balance Sheet Items (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $97,805 | $99,120 | | Marketable securities | $230,693 | $259,172 | | Total Assets | $406,061 | $441,073 | | Total current liabilities | $32,808 | $36,217 | | Total Liabilities | $36,084 | $39,436 | | Total shareholders' deficit | ($998,553) | ($994,954) | Consolidated Statements of Operations ProKidney reported a minimal revenue of $230 thousand in Q1 2025, with operating loss widening to $41.4 million and net loss per Class A share improving to $(0.13) due to increased shares outstanding Q1 Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $230 | $– | | Research and development | $27,263 | $27,233 | | General and administrative | $14,355 | $12,843 | | Operating Loss | ($41,388) | ($40,076) | | Interest Income | $4,027 | $4,843 | | Net loss before noncontrolling interest | ($37,952) | ($35,333) | | Net Loss per Share (Basic & Diluted) | $(0.13) | $(0.16) | | Weighted average Class A shares | 128,976,366 | 60,951,721 | Consolidated Statements of Cash Flows Net cash used in operating activities improved to $29.6 million in Q1 2025, while net cash provided by investing activities was $28.3 million, resulting in a slight decrease in cash and cash equivalents to $97.8 million by quarter-end Q1 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($29,592) | ($34,646) | | Net cash provided by investing activities | $28,289 | $58,399 | | Net cash used in financing activities | ($12) | ($13) | | Net change in cash and cash equivalents | ($1,315) | $23,740 | | Cash, end of period | $97,805 | $84,389 | About ProKidney Corp. & Forward-Looking Statements ProKidney is a clinical-stage company focused on rilparencel, an autologous cellular therapy for CKD with RMAT designation, and the report includes forward-looking statements subject to inherent risks - ProKidney's lead product candidate is rilparencel, a first-in-class, autologous cellular therapy for diabetic patients at high risk of kidney failure, which has been granted RMAT designation by the FDA[13] - The report includes forward-looking statements regarding clinical trial timing, potential regulatory approvals, and financial runway, which are not guarantees of future performance and are subject to various risks and uncertainties detailed in the company's SEC filings[14][15]