Core Viewpoint - ProKidney's stock experienced a significant increase due to positive trial results for its lead candidate, rilparencel, aimed at treating late-stage chronic kidney disease (CKD) [2][4][5] Group 1: Stock Performance - ProKidney's stock rose from less than $1 per share at the end of June to $5.18 per share by July 10, marking a 775% gain in just 10 days [1] - As of July 18, ProKidney's market cap was $408 million, indicating a low valuation for a company potentially launching a treatment for over a million patients [15] Group 2: Clinical Trial Results - The phase 2 Regen-007 trial results showed that treatment with rilparencel stabilized kidney function, with a 78% slower decline in eGFR for patients receiving two injections compared to the placebo group [6][10] - A secondary group receiving a single injection showed a 50% lower annual rate of eGFR decline compared to the placebo, but the sample size of 25 patients was not statistically significant [11][10] - ProKidney is currently enrolling patients in a phase 3 trial, with results expected in 2026 [9][12] Group 3: Regulatory Insights - ProKidney's management reported positive feedback from the FDA regarding the approval path for rilparencel, with the agency accepting improved eGFR decline rates as a surrogate endpoint [13] - This could allow ProKidney to submit an application package to the FDA before the end of next year [13] Group 4: Financial Position - ProKidney ended March with $328.5 million in cash after a burn of $38 million in the first quarter, indicating sufficient resources for ongoing operations [16]

Core Viewpoint - ProKidney Corp. has experienced significant stock volatility following positive Phase 2 clinical trial results for its REGEN-007 study, which shows promise for treating chronic kidney disease (CKD) and diabetes [2][5]. Group 1: Clinical Trial Outcomes - The Phase 2 trial results indicated a 78% improvement in the annual decline of estimated glomerular filtration rate (eGFR) for Group 1 participants who received two rilparencel injections [6]. - Group 2 participants, who received a single injection with a conditional second injection, showed a 50% improvement in annual eGFR decline, although this result was not statistically significant [6]. - These findings represent a significant clinical milestone, as CKD affects millions globally and treatment options are limited [2]. Group 2: Market Response and Stock Performance - Following the positive trial results, ProKidney's stock surged over 500% on July 8, although it remains over 70% below its 2023 peak of approximately $13 [2]. - Current analyst consensus price targets are around $4.00, suggesting the stock may be fairly valued at its current levels [3]. Group 3: Financial Position - ProKidney holds a robust cash balance of $358 million, representing 81% of its total assets, and has a minimal debt load of $3.2 million, resulting in a debt-to-equity ratio below 1% [3]. - The company incurred operating expenditures totaling $185 million over the past year and has no commercial products generating revenue, necessitating continuous observation of its cash burn rate [4]. Group 4: Risks and Challenges - The uncertainty surrounding the Phase 3 trial poses a significant risk, as success in Phase 2 does not guarantee success in subsequent phases or regulatory approvals [5]. - ProKidney faces competitive risks from other companies developing therapies for CKD and has a limited pipeline reliant on rilparencel, which adds to its risk profile [5]. - The stock has shown substantial price fluctuations, with a notable decline of 91% from a high of $13.78 on March 13, 2023, to $1.21 on November 17, 2023 [5].

Powered by passion. Driven by patient care. Corporate Presentation Disclaimer This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our anticipated financial results of the fiscal quarter and full year ended December 31, 2024; our commerc ...