Latest news with #rilparencel
Yahoo
3 days ago
- Business
- Yahoo
This Biotech Stock Jumped Over 600% in Just Days After Releasing Promising Clinical Trial Data. And Its Market Cap Is Still Only $2 Billion. But Is It a Buy?
Key Points Shares of ProKidney surged last week after the company reported encouraging phase 2 trial data. Rilparencel is a cell therapy that could generate up to $900 million in revenue per year for the business. However, it could still be more than a year before phase 3 trial data comes out. 10 stocks we like better than ProKidney › Biotech stocks can be risky but exciting investments because they can soar quickly on positive news, such as a drug approval or simply the hope that they may soon have an approved treatment. They can drop just as quickly on negative news. One stock that has recently skyrocketed is ProKidney (NASDAQ: PROK). At the start of the month, it was firmly in penny stock territory, with a price of less than $0.60. But as of the end of last week, it was up over $4.50, having taken off in value on some encouraging developments. And yet, even despite soaring well over 600% in less than a week, its market cap remains at around $2 billion as I write this. What's behind the healthcare stock's impressive rally, and should you consider investing in ProKidney today? The catalyst behind ProKidney's surge On July 8, shares of ProKidney rose by 515%, and trading volumes also spiked, from 820,000 shares the previous day to more than 343 million. The reason for the bullishness is that the company released phase 2 trial results for rilparencel, a promising cell therapy it is developing as a treatment for chronic kidney disease (CKD) and diabetes. There were no serious adverse events noted in the trial, and the data showed that the treatment has potential in helping preserve kidney function for people with CKD and diabetes. At its peak, analysts believe that rilparencel could generate $900 million in annual revenue. That may put the company on a path toward profitability, but it's by no means a sure thing since it first needs to obtain approval. And phase 3 trial data, which often can determine a treatment's likelihood of approval, is still likely more than a year away. The stock has dropped a bit since the July 8 surge. ProKidney is in good position to handle its ongoing cash burn The name of the game for biotech companies that are in the midst of developing drugs and treatments is to keep their costs down as low as possible, and to minimize the need for cash infusions. With minimal revenue, ProKidney is a cash-burning machine right now, and its expenses may rise, especially as it progresses in later-stage trials, which are larger and more costly to run. Through the first three months of the year, the company used up just under $30 million in cash for its day-to-day operating activities. The good news is that with cash and marketable securities totaling $328 million, the business appears to be well funded and in good shape to continue investing in its research and development without needing to issue shares anytime soon. Given its current resources, it has some runway. Is ProKidney stock a buy? Shares are up big of late, but a few years ago ProKidney reached highs of over $13 per share. (It closed Tuesday at $3.37.) Biotech stocks can go on roller-coaster rides as they struggle with burning cash. And while encouraging clinical trial results can have positive effects, they may not be enough reason for a stock's value to remain high. In the case of ProKidney, until and unless rilparencel obtains approval from regulators, this is going to remain a risky and volatile stock. And given its recent surge, some investors may be tempted to cash out on the excitement, especially since there's still plenty of risk. At a near $2 billion valuation, I would hold off on buying the stock right now since there could still be a lot of room for it to fall back down. The phase 2 results may have been encouraging, but that doesn't guarantee that phase 3 will also be positive and that approval for rilparencel is inevitable. It could still be a long road ahead for ProKidney before it proves to be a good growth stock. Unless you have a high risk tolerance, you may be better off simply waiting on the sidelines. Should you invest $1,000 in ProKidney right now? Before you buy stock in ProKidney, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and ProKidney wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $679,653!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,046,308!* Now, it's worth noting Stock Advisor's total average return is 1,060% — a market-crushing outperformance compared to 179% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 15, 2025 David Jagielski has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This Biotech Stock Jumped Over 600% in Just Days After Releasing Promising Clinical Trial Data. And Its Market Cap Is Still Only $2 Billion. But Is It a Buy? was originally published by The Motley Fool
Yahoo
6 days ago
- Business
- Yahoo
ProKidney Just Set a New 52-Week High. Should You Buy, Sell, or Hold PROK Stock Here?
Chronic kidney disease (CKD) is a silent epidemic. In this high-stakes space, biotechnology companies focused on reversing or slowing CKD progression are racing for a breakthrough. Successful clinical trials are not only scientific wins, but the catalysts that can ignite sector-wide rallies. Especially when the weapon isn't another pill, but cell therapy — an approach that could redefine kidney care as we know it. One such player that just jolted the market is ProKidney (PROK), a biotech making noise with bold science and even bolder stock moves. Once backed by SPAC king Chamath Palihapitiya, this overlooked biotech stock just pulled off a 515% surge thanks to impressive top-line data from its Phase 2 REGEN-007 trial. Its autologous cell therapy, rilparencel (REACT), significantly slowed kidney function decline. Shopify Stock is a Bargain - How to Make a 3.2% One-Month Yield with SHOP Tariffs, Inflation and Other Key Things to Watch this Week Stocks Set to Open Lower as Trump Ratchets Up Tariff Threats, U.S. Inflation Data and Big Bank Earnings Awaited Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. While some on Wall Street are optimistic, raising price targets and seeing real potential for accelerated approval, others remain skeptical, pointing to trial design gaps and warning that PROK stock may have sprinted too far, too fast. So, should investors ride the wave of optimism and snag shares? Or is this rally already baked into the price? Founded in 2015, ProKidney is a clinical-stage biotech tackling CKD with regenerative cell therapy. In 2022, it went public through a $2.6 billion SPAC merger with Social Capital Suvretta Holdings, backed by Chamath Palihapitiya. Its lead candidate, rilparencel, is a first-in-class minimally invasive autologous cell therapy designed to preserve or even improve kidney function, potentially delaying or eliminating the need for dialysis. Now in a Phase 3 trial, ProKidney is drawing attention as it reimagines what's possible for CKD patients. ProKidney went public at around $10 per share, but the stock soon lost momentum, slipping into penny territory. For a while, it stayed quiet. That was until July 2025 flipped the narrative. Following strong Phase 2 trial results for its CKD therapy, PROK stock skyrocketed more than 600% in just five days, hitting a 52-week high of $7.13 on July 9 before cooling to $4.34 — still a massive leap from $0.61 just two days earlier. Despite the breather, PROK stock is up 169% on a year-to-date (YTD) basis. The rally pushed its market capitalization from $177 million to over $1 billion. Plus, on July 8 alone, over 343 million shares changed hands, signaling aggressive buying interest. On May 12, ProKidney dropped its fiscal first-quarter 2025 numbers, and Wall Street liked what it saw. The stock jumped 15.8% in the next trading session — not bad for a clinical-stage biotech still chasing its first product approval. While technically still pre-revenue, the company logged $230,000 at the top line, with a per-share loss of $0.13, beating the Street's expectations and improving by nearly 19% year-over-year (YOY). R&D spending held steady at $27.3 million, with hiring and facility costs nudging higher, offset by lower clinical trial expenses due to the winding down of earlier-phase programs. General and administrative costs rose to $14.4 million, mainly from increased salaries and professional fees, typical for a company scaling up for a pivotal Phase 3. Importantly, ProKidney ended the quarter with a solid $328.5 million in cash, giving it runway through mid-2027. That's enough to push its lead therapy through late-stage testing. But if trial costs balloon, talks of dilution or partnerships could heat up. Analysts tracking the company anticipate its per-share losses to shrink by 21% YOY to $0.49 in fiscal 2025, then narrow another 4% to $0.47 in fiscal 2026. ProKidney's recent rally was more than just market noise. It was a reaction to meaningful clinical signals. The company's Phase 2 REGEN-007 trial revealed that rilparencel significantly slowed kidney function decline in patients with CKD and diabetes, and that's a big deal. Importantly, the U.S. Food and Drug Administration had previously indicated that rilparencel could qualify for accelerated approval if a validated surrogate endpoint showed strong results. That bar was seemingly met in Group 1 of the trial as it saw an annual improvement of 78% in 'eGFR slope' (the rate of kidney function decline), strengthening the case for regulatory momentum. With a critical FDA meeting scheduled this summer, Wall Street caught wind of the momentum, and the stock blasted off on renewed optimism. However, enthusiasm must be tempered. The trial had a small sample size, and while Group 1 showed promise, the 50% improvement in eGFR slope in Group 2 was 'not statistically significant,' raising questions about consistency and durability. Regulators may demand harder endpoints in Phase 3 instead of relying only on eGFR improvements. Meanwhile, competition is also heating up, with contenders like Eli Lilly (LLY) and Novo Nordisk (NVO) racing forward in the same space. And as a small-cap biotech, with no product revenue yet, ProKidney remains highly volatile and vulnerable to both hype and setbacks. Wall Street is split on ProKidney's explosive run, with some eyeing a true biotech breakout while others question the substance behind the surge. Citi sees promise and took the bullish lane. The firm kept a 'Buy' rating and hiked PROK stock's price target from $6 to $9, calling the early Phase 2 data better than expected. Citi now sees a 60% probability of success for rilparencel. With statistically and clinically meaningful results, analysts believe the therapy could fast-track toward approval if Phase 3 holds up. But not everyone's buying the breakout. Bank of America stayed firmly in the skeptic camp, maintaining its 'Underperform' rating and $1 price target. The firm's concerns run deep — no sham comparator in the REGEN-007 trial, limited weight from open-label eGFR data, and uncertainty over which patients drove the results. Even more, the bank flagged ambiguity around the regulatory path and warned the Phase 3 timeline could stretch beyond ProKidney's cash runway. Analysts also questioned whether the market for rilparencel is large enough without exceptionally strong data. Evercore ISI struck a more measured tone. Analyst Jonathan Miller called the top-line results 'very intriguing,' but said they're still holding off on buying the stock. While the ongoing Phase 3 trial could be a major catalyst in kidney care, results are not expected any sooner. PROK stock has a consensus 'Moderate Buy' rating overall. Out of seven analysts covering the biotech stock, four recommend a 'Strong Buy,' two give a 'Hold,' and one analyst gives a 'Moderate Sell' rating. Amid the sharp climb this week, PROK stock has edged past its average price target. Meanwhile, Citi's Street-high target of $9 suggests shares could rally as much as 98%. ProKidney just lit up the biotech radar with a massive stock surge and promising trial data, but the hype comes with high-stakes risk. PROK stock's ride from penny status to a $1 billion valuation was fast, volatile, and fueled by future hopes, not current revenue. Analysts remain split, and FDA approval is still a ways off. If investors are in, they'll need to brace for turbulence as this is not a classic steady climber. The potential is real, but so are the risks. On the date of publication, Sristi Suman Jayaswal did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
09-07-2025
- Business
- Globe and Mail
ProKidney to Participate in the H.C. Wainwright 4th Annual Kidney Virtual Conference
WINSTON-SALEM, N.C., July 09, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ('ProKidney' or the 'Company'), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the upcoming H.C. Wainwright 4 th Annual Kidney Virtual Conference: H.C. Wainwright 4 th Annual Kidney Virtual Conference Date: Monday, July 14, 2025 Time: 1:30pm ET Format: Fireside Chat Webcast: Link The live webcast will be accessible through the 'Events' section of the Investor Relations tab within ProKidney's website at Investors interested in one-on-one meetings should contact their H.C. Wainwright representative. About ProKidney Corp. ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney's lead product candidate, rilparencel (also known as REACT ®), is a first-in-class, patented, proprietary autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies for its potential to preserve kidney function in diabetic patients at high risk of kidney failure. Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. For more information, please visit Investor Contacts:
Yahoo
08-07-2025
- Business
- Yahoo
ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes
Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial In Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was statistically significant (p<0.001) and clinically meaningful In Group 2 (n=25), patients were randomized to receive a single rilparencel injection followed by a second injection only if kidney function worsened and a re-dosing trigger was met. The annual decline in eGFR slope improved by 50% from -3.4 mL/min/1.73m2 in the pre-injection period to -1.7 mL/min/1.73m2 in the period following the last rilparencel injection. This 1.7 mL/min/1.73m2 per year difference was not statistically significant (p=0.085) but suggests evidence of a dose response No rilparencel-related serious adverse events were observed; the safety profile was consistent with previously reported study results and comparable to a kidney biopsy FDA Type B meeting set for this summer to confirm ProKidney's approach to using eGFR slope as the surrogate endpoint in the ongoing Phase 3 PROACT 1 study for accelerated approval WINSTON-SALEM, N.C., July 08, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ('ProKidney' or the 'Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (mITT) population of the Phase 2 REGEN-007 trial evaluating rilparencel in patients with CKD and diabetes. Rilparencel is an autologous cellular therapy that has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food & Drug Administration (FDA) and is currently being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate the therapy's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. 'We are very encouraged by the REGEN-007 topline results that demonstrated a robust improvement in eGFR slope following treatment with rilparencel in Group 1 as well as evidence of a dose response in Group 2. These data bolster our confidence in the design of our ongoing Phase 3 PROACT 1 study given the similarity between the dosing regimen in REGEN-007 Group 1 and PROACT 1. It is also worth noting that 15 of the 24 patients in Group 1 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. We plan to submit the full results from REGEN-007 to ASN's 2025 Kidney Week as a late-breaking clinical trial and are excited to share more details at that time with investors and the medical community,' said Bruce Culleton, M.D., CEO of ProKidney. 'We also look forward to our upcoming FDA Type B meeting in the coming weeks to confirm our approach to eGFR slope as a surrogate endpoint for accelerated approval. This meeting represents an important step toward our goal of expediting rilparencel's potential path to market in the U.S. where there remains a significant unmet clinical need in patients with advanced CKD and diabetes.' Phase 2 REGEN-007 Overview and Topline ResultsREGEN-007 is a multi-center Phase 2 open-label 1:1 randomized two-arm trial in patients with diabetes, CKD, and an estimated glomerular filtration rate (eGFR) of 20-50 mL/min/1.73m². At randomization, patients were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of the ongoing Phase 3 PROACT 1 study in which patients received two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients received a single rilparencel injection in one kidney and a second injection in the contralateral kidney only if triggered by a sustained eGFR decline from baseline of ≥ 20%, and/or an increase in the urine albumin to creatinine ratio (UACR) from baseline of ≥ 30% and ≥ 30 mg/g. The prespecified primary endpoint for REGEN-007 is the difference in annual eGFR slope (calculated using a linear mixed effects model) in the pre-injection period versus the period following the last rilparencel injection. The pre-injection period included all historical eGFR values collected up to 24 months before the screening visit as well as the on-study central laboratory eGFR results prior to first rilparencel injection. The period following the last injection included eGFR values from the last rilparencel injection to the end of study (EOS) visit. Median follow-up after the last injection was approximately 18 months in both Group 1 and Group 2. Fifty-three patients were randomized in the study, of whom 49 patients (mITT population) received at least one rilparencel injection. Four patients did not receive any rilparencel injections. The majority of patients were male (69%), and the mean age was 60 years. At baseline, 38 of 49 patients (78%) had type 2 diabetes mellitus and 11 (22%) had type 1 diabetes. Thirty-nine (80%) patients were receiving an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), and 18 (37%) were receiving a sodium-glucose cotransporter-2 inhibitor (SGLT2i). At baseline, the mean (SD) eGFR was 33±10 mL/min/1.73m2. Notably, the median UACR was higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g). Annual eGFR Slope (mL/min/1.73m2) Group N (mITT) Pre inj Post last inj Absolute benefit Relative benefit 1 24 -5.8 -1.3 4.6 78% 2 25 -3.4 -1.7 1.7 50% In Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference1 was statistically significant (p<0.001) and clinically meaningful. Of the 24 patients in Group 1, 15 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. As a reminder, the Phase 3 PROACT 1 protocol was amended in 1H 2024 after a similar eGFR efficacy signal was observed in the Phase 2 RMCL-002 study subgroup analysis (n=23) of high-UACR, Stage 4 CKD patients with type 2 diabetes. In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m2 in the pre-injection period versus -1.7 mL/min/1.73m2 in the period following the last rilparencel injection, resulting in an improvement of 50%, or 1.7 mL/min/1.73m2 per year. This difference was not statistically significant (p=0.085) but suggests evidence of a dose response. Out of the 25 patients in Group 2, 15 (60%) met the re-dosing trigger and received a second rilparencel injection. The median time between the first and second injections in these 15 patients was approximately 11 months. No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The safety profile was consistent with previously reported study results and comparable to a kidney biopsy. Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology (ASN) 2025 Kidney Week as a late-breaking clinical trial. Phase 3 PROACT 1 Regulatory ProgressAs previously communicated, the FDA confirmed during a Type B meeting in Q4 2024 that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, such as eGFR slope, is used. ProKidney has an upcoming FDA Type B meeting this summer to confirm the approach to using eGFR slope as the surrogate endpoint for accelerated approval. Additional details are expected in mid-2025. About Chronic Kidney DiseaseCKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undiagnosed in the early stages. Diabetes is the leading cause of CKD, and individuals with both conditions face significantly elevated risks of cardiovascular events, hospitalization, and mortality. ProKidney is developing rilparencel for patients with Stage 3b/4 CKD and diabetes, a population that includes 1 to 2 million people in the U.S. While current treatment options aim to slow disease progression, there remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD. About the Phase 3 REGEN-006 (PROACT 1) Clinical TrialREGEN-006 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with advanced CKD and type 2 diabetes. The study protocol was amended in 1H 2024 to focus on a subset of patients with Stage 4 CKD (eGFR 20-30 mL/min/1.73m²) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m²) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m² and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m²). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. The primary objective is to assess the efficacy of up to two rilparencel injections (one in each kidney) using a minimally invasive percutaneous approach. The primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m², and/or chronic dialysis, and/or renal transplant; or renal or cardiovascular death. About ProKidney a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney's lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cellular therapy being evaluated for its potential to preserve kidney function in diabetic patients at high risk of kidney failure. Rilparencel has received RMAT designation from the FDA. For more information, please visit Forward-Looking StatementsThis press release includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. ProKidney's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company's beliefs that the FDA agrees that the Company's Phase 3 REGEN-006 (PROACT 1) trial could be sufficient to support a potential BLA submission and full regulatory approval and that the Company could consider using eGFR slope as a surrogate endpoint on an accelerated approval pathway for rilparencel, expectations with respect to financial results and expected cash runway, including the Company's expectation that current cash will support operating plans into 2027, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company's products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company's products, if approved, the advancement of the Company's development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings or achieving other milestones related to the Company's product candidates, and the advancement and funding of the Company's developmental programs, generally. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: disruptions to our business or that may otherwise materially harm our results of operations or financial condition as a result of our recent domestication to the United States; the inability to maintain the listing of the Company's Class A common stock on Nasdaq; the inability of the Company's Class A common stock to remain included in various indices and the potential negative impact on the trading price of the Class A common stock if excluded from such indices; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company's clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company's drug candidates; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company's products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's financial performance; the Company's intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company's business; and other risks and uncertainties included under the heading 'Risk Factors' in the Company's most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. Investor Contacts: ProKidneyEthan Advisors, LLCDaniel Ferry Daniel@ 1 Difference in values is due to in to access your portfolio
