Core Viewpoint - ProKidney Corp. (PROK) has experienced significant selling pressure, resulting in a 38% decline in stock price over the past four weeks, but analysts anticipate better earnings than previously expected, indicating a potential rebound for the stock [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is utilized to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - PROK's current RSI reading is 28.01, suggesting that the heavy selling may be exhausting itself and a price reversal could occur soon [5]. Group 2: Fundamental Indicators - Analysts have raised earnings estimates for PROK by 1.5% over the last 30 days, indicating a positive trend that often leads to price appreciation [6]. - PROK holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7].

Financial Performance - The company reported net losses before noncontrolling interest of $163.3 million, $135.4 million, and $148.1 million for the years ended December 31, 2024, 2023, and 2022, respectively [222]. - As of December 31, 2024, the company had an accumulated deficit of $1,200.8 million [222]. - The company had approximately $358.3 million in cash, cash equivalents, and short-term investments as of December 31, 2024, which is expected to fund operations into mid-2027 [226]. - The company expects to incur substantial research and development expenses and may never achieve profitability [224]. Clinical Development and Regulatory Approval - The company is currently in Phase 3 clinical development for its lead product candidate, rilparencel, and has not generated any revenue to date [241]. - The company anticipates significant increases in expenses as it advances the development of rilparencel and other future product candidates through clinical trials [223]. - The company must complete clinical development and obtain regulatory approval before generating revenue from rilparencel [243]. - The regulatory approval process for rilparencel may be more expensive and take longer than for other, better-known products due to its complexity and novelty [247]. - The company has not previously conducted any later stage or pivotal clinical trials and has limited experience in preparing regulatory filings [243]. - The company may face delays or interruptions in clinical trials and regulatory approvals, which could adversely affect its operations [227]. - The company must demonstrate substantial evidence of safety and efficacy through well-controlled clinical trials to satisfy regulatory authorities [273]. - The company may face delays in clinical trials due to various factors, including regulatory compliance and patient recruitment challenges [265]. - The company may experience setbacks that could delay or prevent regulatory approval or commercialization of rilparencel [244]. - The design or execution of clinical trials may not support marketing approval, and variability in results could affect the commercialization of rilparencel [299]. Competition and Market Dynamics - The company faces significant competition in the biologics market, particularly in the treatment of kidney disease, from both established pharmaceutical companies and emerging therapies [237]. - Market acceptance of rilparencel and future product candidates is uncertain, with factors such as efficacy, pricing, and physician willingness to prescribe affecting potential revenues [351]. - The total addressable market for rilparencel may be smaller than projected, impacting revenue potential and market strategy [358]. - The company faces potential competition from biosimilar products, which could impact the commercial prospects of rilparencel [367]. Manufacturing and Supply Chain - Manufacturing of cell therapies, including rilparencel, is complex and has faced delays due to regulatory compliance issues, necessitating a pause in manufacturing to meet EU standards [315]. - The company aims to reduce manufacturing costs for rilparencel by optimizing bioprocess development and exploring reduced culture media usage [320]. - The company may need to expand its manufacturing vendors to meet rising demand, which could require significant capital investment and regulatory approvals [325]. - The complexity of managing an autologous ex vivo cell therapy supply chain poses significant operational challenges, including timely transportation and storage of cellular materials [335]. - The company relies on third-party suppliers for critical materials, and any disruption in supply could significantly impact its ability to meet customer demand and harm its business [340]. Regulatory Compliance and Risks - The company must navigate complex health care laws and regulations, which could expose it to significant legal and financial risks [401]. - Regulatory compliance is critical, as the company will be subject to extensive oversight and requirements upon commercialization of rilparencel, which could lead to significant additional expenses [406]. - The company may face penalties if it fails to comply with regulatory requirements or experiences unforeseen problems with rilparencel or future product candidates [406]. - The FDA's policies may change, potentially delaying or preventing marketing approval for rilparencel and future product candidates, adversely affecting the company's business and profitability [409]. Funding and Capital Requirements - The company has no committed external source of funds for its development efforts and may need to raise additional capital through various means, including public or private equity offerings [230]. - The company may need to raise additional capital to pursue further development or commercialization of product candidates if collaborations are not successful [399]. - The company faces significant uncertainty regarding the coverage and reimbursement status of any products that may receive regulatory approval, which is essential for patient access [374]. Clinical Trial Challenges - Patient enrollment in clinical trials has been challenging, with competition from other trials potentially delaying the development of rilparencel [292]. - The company may experience delays in clinical development or marketing schedules due to potential microbial contamination in the manufacturing process [344]. - The handling and administration of rilparencel require strict adherence to specific protocols, and any deviation could negatively impact product efficacy and safety [346]. Future Collaborations - Future collaborations for the development and commercialization of rilparencel and other product candidates are crucial, and failure to establish these collaborations could adversely affect the business [393]. - The negotiation process for collaborations is complex and time-consuming, with significant competition for suitable partners, which may hinder the company's ability to secure necessary agreements [397].

Financial Performance - The net loss before noncontrolling interest was $163.3 million for 2024, compared to $135.4 million in 2023[10]. - Revenue for 2024 was $76,000, compared to $0 in 2023 and 2022[21]. - Net loss attributable to Class A ordinary shareholders was $61,186, compared to a loss of $35,468 in 2023[21]. - Basic and diluted net loss per share attributable to Class A ordinary shares was $(0.62), compared to $(0.57) in 2023[21]. Funding and Cash Position - ProKidney secured $140 million in equity funding to extend its cash runway into mid-2027, ending Q4 2024 with $358 million in cash and cash equivalents[5][7]. - Cash and cash equivalents at the end of the period were $99,120, up from $60,649 in 2023[23]. - Proceeds from sales of Class A ordinary shares were $144,322, with no proceeds in 2023[23]. - Net cash flows used in operating activities were $126,351, an increase from $90,069 in 2023[23]. - Net cash flows provided by investing activities were $20,414, a recovery from a net cash outflow of $329,983 in 2023[23]. Expenses - Research and development expenses increased to $127.7 million in 2024, up from $106.7 million in 2023, primarily due to higher personnel costs and clinical trial expenses[8]. - General and administrative expenses rose to $56.1 million in 2024, compared to $44.8 million in 2023, driven by increased cash-based compensation and an impairment charge of $5.3 million[9]. - Total operating expenses increased to $183,752, up 21.3% from $151,522 in 2023[21]. Clinical Development - The FDA confirmed an accelerated approval pathway for rilparencel, contingent on an acceptable surrogate endpoint, with additional details expected in mid-2025[6]. - Full data from Group 1 of the Phase 2 REGEN-007 study is anticipated in Q2 2025, with interim results showing kidney function stabilization for 18 months in patients with advanced CKD and diabetes[5][6]. - The company discontinued the Phase 3 REGEN-016 study to focus on the REGEN-006 (PROACT 1) trial, which could support a potential Biologics License Application submission[6]. - The company plans to expedite rilparencel's path to market in the U.S. to provide a new therapeutic option for patients with advanced CKD and diabetes[3]. - ProKidney's lead product candidate, rilparencel, has received Regenerative Medicine Advanced Therapy designation from the FDA[14]. Assets - Total assets increased to $441.1 million as of December 31, 2024, compared to $420.6 million at the end of 2023[19].

Core Insights - ProKidney Corp. experienced significant advancements in 2024, focusing on chronic kidney disease (CKD) and preparing for the market introduction of its lead product, rilparencel [2][4][6] Financial Highlights - As of December 31, 2024, ProKidney had cash, cash equivalents, and marketable securities totaling $358.3 million, a slight decrease from $363.0 million in 2023, which is expected to fund operations into mid-2027 [4] - Research and development expenses rose to $127.7 million in 2024 from $106.7 million in 2023, primarily due to increased personnel costs and clinical trial expenses [5] - General and administrative expenses increased to $56.1 million in 2024 from $44.8 million in 2023, driven by higher cash-based compensation and an impairment charge [6][8] - The net loss before noncontrolling interest was $163.3 million in 2024, compared to $135.4 million in 2023 [8][17] Clinical and Regulatory Developments - The Phase 3 REGEN-006 (PROACT 1) trial was refined to target advanced CKD patients, with the FDA confirming an accelerated approval pathway for rilparencel if an acceptable surrogate endpoint is used [2][7] - Full data from Group 1 of the Phase 2 REGEN-007 study is expected in Q2 2025, with interim results showing kidney function stabilization for 18 months in patients with advanced CKD and diabetes [7][12] - The company discontinued the Phase 3 REGEN-016 (PROACT 2) study to focus on the more promising REGEN-006 trial [7] Funding and Equity - ProKidney secured $140 million in equity funding in 2024, which will extend its cash runway into mid-2027 [2][6] - The total number of shares outstanding as of December 31, 2024, was 291,748,124 [9]

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of ProKidney Corp. related to self-dealing, which may entitle shareholders to damages and corporate governance reforms [1]. Group 1 - The investigation by Kuehn Law focuses on whether certain officers and directors of ProKidney Corp. have engaged in self-dealing that could harm shareholder interests [1]. - Shareholders of ProKidney Corp. are encouraged to contact Kuehn Law for a free consultation regarding their rights and potential claims [2]. - The firm emphasizes the importance of shareholder participation in maintaining the integrity and fairness of financial markets [3].

ProKidney (NASDAQ: PROK ) is a biotech that works on autologous cellular therapy for organs. In easier terms, PROK tries to preserve organs with its technology, and currently, its leading candidate is Rilparencel (React) for chronic kidney disease [CKD]. In particular, Rilparencel uses patients’ kidney cells to stabilize or slow downMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree ...

Company Overview - ProKidney Corp. is a late clinical-stage biotech company focused on developing a first-in-class cell therapy candidate for chronic kidney disease (CKD) [1][3] - The company was founded in 2015 after a decade of research and is pioneering treatments for CKD through innovations in cellular therapy [3] Product Information - ProKidney's lead product candidate, rilparencel (also known as REACT), is an autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies [3] - Rilparencel aims to preserve kidney function in diabetic patients at high risk of kidney failure and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA [3] Upcoming Events - ProKidney's CEO, Bruce Culleton, M.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025, at 7:30 am PST [1][2] - The management team will also host one-on-one meetings throughout the event, and a live webcast of the presentation will be available on the company's website [2]

Company Overview - ProKidney Corp. is a late clinical-stage biotech company focused on developing a first-in-class cell therapy candidate for chronic kidney disease (CKD) [1][2] - The company was founded in 2015 and has a decade of research behind its innovations in cellular therapy [2] Product Information - ProKidney's lead product candidate, rilparencel (also known as REACT®), is an autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies [2] - Rilparencel aims to preserve kidney function in diabetic patients at high risk of kidney failure and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA [2] Upcoming Events - ProKidney's management team will participate in two healthcare conferences in December 2024: - Evercore HealthCONx Conference on December 3, 2024, at 8:45 am ET in a fireside chat format [1] - Citi Global Healthcare Conference on December 4, 2024, featuring one-on-one meetings [1] - The live webcast for the Evercore fireside chat will be available on ProKidney's website [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | |----------------------------------------------------------------------------------------------------------------------|------------------- ...

Exhibit 99.1 | --- | --- | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | | | | ProKidney Reports Third Quar ...