Aankondiging • Jun 02
Prokidney Corp. Announces Appointment of Kenneth Locke as Chief Technical Officer ProKidney Corp. announced the appointment of Kenneth Locke as Chief Technical Officer. Kenneth Locke joined as Chief Technical Officer, bringing more than 25 years of experience across Chemistry, Manufacturing and Controls (CMC) and Supply Chain as ProKidney progresses toward the potential commercialization of rilparencel. Mr. Locke joined ProKidney from Carisma Therapeutics, where he oversaw CMC, Quality and Regulatory functions and led technical strategy for first-in-human CAR Myeloid programs. He built and scaled teams to support clinical development and contributed to strategic asset transitions through licensing and technology transfer of cell and viral vector manufacturing processes. Previously, he held leadership roles at Celgene (now Bristol Myers Squibb), where he led external manufacturing and strategic sourcing for cell therapy programs, and at Novartis, where he helped advance early-stage cell therapy programs and established global capabilities across manufacturing and supply chain. Mr. Locke began his career in research and procurement roles of increasing responsibility at Bristol Myers Squibb and other biopharmaceutical organizations. He holds a Master of Science in Molecular Biology from Lehigh University and a Bachelor of Science in Biology Education from Millersville University of Pennsylvania. Reported Earnings • May 18
First quarter 2026 earnings released: US$0.14 loss per share (vs US$0.13 loss in 1Q 2025) First quarter 2026 results: US$0.14 loss per share (further deteriorated from US$0.13 loss in 1Q 2025). Net loss: US$20.0m (loss widened 20% from 1Q 2025). Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Global Biotechs industry. Aankondiging • Apr 21
ProKidney Corp., Annual General Meeting, May 28, 2026 ProKidney Corp., Annual General Meeting, May 28, 2026. Location: 399 boylston street, suite 350, massachusetts 02116, boston United States Aankondiging • Mar 26
Prokidney Corp. Appoints Greg Madison as Chief Commercial Officer ProKidney Corp. announced the appointment of Greg Madison as Chief Commercial Officer. In this role, Mr. Madison will drive ProKidney’s commercial strategy as the company advances towards the potential commercialization of rilparencel. Mr. Madison brings more than two decades of executive leadership experience across commercial strategy, general management, launch planning, business development, and company building in both clinical and commercial-stage biopharmaceutical companies. Most recently, he served as Chief Executive Officer of Shield Therapeutics plc, where he redesigned the commercial strategy, identified and led a transformative business development transaction, and raised capital to position the company on a path to profitability. Previously, he was Chief Executive Officer of Melt Pharmaceuticals, creating the company and advancing a novel sublingual combination drug from preclinical to Phase 2. Prior to that, he served as President and CEO of Keryx Biopharmaceuticals, leading its evolution from a clinical to commercial-stage organization, launching a novel iron-based phosphate binder for dialysis patients, and advancing a second indication for iron deficiency anemia. Earlier in his career, Mr. Madison was Executive Vice President and Chief Commercial Officer of AMAG Pharmaceuticals, and Vice President/General Manager of the Global Renal Business at Genzyme, where he helped drive Renagel/Renvela to blockbuster status with over $1 billion in annual revenue. Recent Insider Transactions • Nov 16
Independent Director recently sold Mex$34m worth of stock On the 13th of November, Brian Jude Pereira sold around 757k shares on-market at roughly Mex$45.47 per share. This transaction amounted to 100% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Aankondiging • Nov 06
Prokidney Corp. Presents Full Results from the Phase 2 Regen-007 Trial of Rilparencel At the American Society of Nephrology Kidney Week 2025 ProKidney Corp. presented full results from the Phase 2 REGEN-007 trial evaluating rilparencel in patients with advanced CKD and diabetes. The data, featured in a late-breaking clinical trials presentation at the American Society of Nephrology (ASN) Kidney Week 2025, further demonstrate the potential of rilparencel to preserve kidney function in patients with advanced CKD and diabetes who are at high risk of kidney failure and have limited therapeutic options. The full Phase 2 trial results presented at ASN Kidney Week 2025 add to the body of clinical data for rilparencel that support the ongoing registrational Phase 3 PROACT 1 study. A first-of-its-kind, proprietary, autologous cell therapy, rilparencel has the potential to be a novel treatment for advanced CKD and diabetes, offering patients an alternative therapeutic option to delay or prevent the need for dialysis. REGEN-007 was a multi-center Phase 2 open-label 1:1 randomized two-arm trial in patients with advanced CKD and diabetes. Eligible participants 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 receive 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 doses of rilparencel. Group 2 received one injection and a second only if a re-dosing trigger was met within 15 months after the first injection. Participants were followed up to 18 months after their last injection. Overall, 87 rilparencel injections in 49 participants were performed during the study. The primary efficacy endpoint was change in eGFR slope from the pre-injection period to the period after the last injection analyzed using a linear mixed model. The primary safety endpoint was the percentage of participants with procedure- and investigational product-related treatment-emergent adverse events (TEAEs). In Group 1 (n=24), bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 improvement in the annual decline in eGFR slope; this 78% improvement was statistically significant and clinically meaningful (p<0.001). Among Group 1 patients, 15 of 24 (63%) met key Phase 3 PROACT 1 inclusion criteria; in this subgroup, bilateral kidney injection resulted in a 5.5 mL/min/1.73m2 improvement in the annual decline in eGFR slope; this 85% improvement was statistically significant and clinically meaningful (p=0.005). Group 2 (n=25) tested an exploratory dosing regimen that resulted in 10 of 25 (40%) patients receiving only one rilparencel injection; following treatment with rilparencel, the annual decline in eGFR slope improved by 1.7 mL/min/1.73m2, or 50%; this improvement was not statistically significant (p=0.085) but suggests evidence of a dose response. Post-hoc analysis of patient subgroups on standard-of-care (SOC) medications, including sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), suggest rilparencel had a treatment effect incremental to that observed with SOC. Rilparencel was well tolerated and had an acceptable safety profile. In Group 1 (N = 24, mITT), the annual eGFR slope before injection was -5.84 mL/min/1.73m² (95% CI: -7.97 to -3.70), and after the last injection it was -1.27 mL/min/1.73m² (95% CI: -3.97 to 1.43). This represents an absolute improvement of 4.57 mL/min/1.73m² (95% CI: 1.95 to 7.18) and a relative improvement of 78%.
In Group 2 (N = 25, mITT), the annual eGFR slope before injection was -3.40 mL/min/1.73m² (95% CI: -5.03 to -1.77), and after the last injection it was -1.71 mL/min/1.73m² (95% CI: -3.78 to 0.36). This corresponds to an absolute improvement of 1.70 mL/min/1.73m² (95% CI: -0.24 to 3.63) and a relative improvement of 50%. Aankondiging • Oct 21
ProKidney Corp. Announces Two Abstracts Selected for Presentation at the American Society of Nephrology's Kidney Week 2025 ProKidney Corp. announced that the Company will present two posters, including a late-breaking poster on the Phase 2 REGEN-007 study results, at the upcoming American Society of Nephrology's (ASN) Kidney Week being held from November 6-9, 2025, in Houston, TX. Aankondiging • Jul 08
Prokidney Corp. Reports Statistically and Clinically Significant Topline Results for the Phase 2 Regen-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes ProKidney Corp. 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. Phase 2 REGEN-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. 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 (cal calculated using a linear mixed effects model) in the pre-injection period versus the period following the last rilparenceljection. The pre-injection period included all historical eGFR values collected up to 24 months before the screening visit as well as a dose response in Group 2. New Risk • May 19
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 26% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 8.4% per year for the foreseeable future. Revenue is less than US$1m (US$306k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$157m net loss in 3 years). Shareholders have been diluted in the past year (26% increase in shares outstanding). Aankondiging • Apr 29
ProKidney Corp., Annual General Meeting, May 29, 2025 ProKidney Corp., Annual General Meeting, May 29, 2025. Location: 399 boylston street, ste. 350, boston, ma 02116, United States New Risk • Apr 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 28% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m (US$76k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$175m net loss in 3 years). Shareholders have been diluted in the past year (28% increase in shares outstanding). New Risk • Apr 09
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: Mex$1.38b (US$66.2m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m (US$76k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$175m net loss in 3 years). Market cap is less than US$100m (Mex$1.38b market cap, or US$66.2m). New Risk • Jan 18
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$113m net loss in 3 years). Shareholders have been diluted in the past year (24% increase in shares outstanding). New Risk • Jan 08
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$113m net loss in 3 years). Shareholders have been diluted in the past year (24% increase in shares outstanding). New Risk • Dec 31
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$113m net loss in 3 years). Shareholders have been diluted in the past year (24% increase in shares outstanding). Board Change • Dec 26
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO & Director Bruce Culleton was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Dec 17
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$113m net loss in 3 years). Shareholders have been diluted in the past year (24% increase in shares outstanding). Board Change • Dec 11
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO & Director Bruce Culleton was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Dec 01
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$113m net loss in 3 years). Shareholders have been diluted in the past year (24% increase in shares outstanding). New Risk • Nov 27
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$113m net loss in 3 years). Shareholders have been diluted in the past year (24% increase in shares outstanding). New Risk • Nov 17
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 4.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$121m net loss in 3 years). Shareholders have been diluted in the past year (24% increase in shares outstanding). Aankondiging • Nov 12
Prokidney Corp. Reports Regulatory and Clinical Development Updates Following Successful FDA Type B Meeting ProKidney Corp. reported several regulatory and clinical development updates. In October, ProKidney had a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss updates to rilparencel’s registrational trial strategy. The FDA confirmed that REGEN-006 (PROACT 1), a single, large, multi-center, well-controlled Phase 3 trial designed to demonstrate substantial evidence of effectiveness and safety, could be sufficient to support a potential Biologics License Application (BLA) submission. Additionally, the FDA confirmed that the accelerated approval pathway is available to rilparencel and that the Company could consider estimated glomerular filtration rate (eGFR) slope as a surrogate endpoint for accelerated approval. ProKidney will continue to engage with the FDA, under its regenerative medicine advanced therapy (RMAT) designation, to further define the details supporting this accelerated pathway. · In late October, the Company presented five poster presentations at the American Society of Nephrology’s (ASN) Kidney Week. This included a poster presentation in the late-breaking clinical trial session on the Phase 2 REGEN-007 study, and four poster presentations focused on rilparencel’s mechanism of action (MOA) and product characteristics. REGEN-006 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with type 2 diabetes and advanced CKD. The study protocol was amended in 1H 2024 to focus on a subset of patients with stage 4 CKD (eGFR 20-30ml min/1.73m2) and late stage 3b CKD (eGFR 30-35ml min/1.73m2) with accompanying albuminuria (urine albumin-to-creatinine ratio, or UACR less than 5,000 mg/g for patients with eGFR 20-30ml min/1.73m2 and 300-5,000 mg/g for patients with eGFR 30-35ml 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. Subjects in the treatment group are to receive the first rilparencel injection within 18 weeks of kidney biopsy. After three months it is intended that a second rilparencel injection be given into the contralateral kidney. Subjects in the control group, who previously underwent the sham biopsy procedure, are to receive two sham injections at similar time points as the treatment group. The primary objective is to assess the efficacy of up to two rilparencel injections 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. New Risk • Sep 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 23% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$111m net loss in 3 years). Shareholders have been diluted in the past year (23% increase in shares outstanding). New Risk • Sep 09
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 23% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$57m net loss in 3 years). Shareholders have been diluted in the past year (23% increase in shares outstanding). Aankondiging • Sep 03
Prokidney Announces Strategic Updates to Its Phase 3 Program to Accelerate Rilparencel’s Registrational Path to Potential Approval in the U.S ProKidney Corp. announced strategic updates to its Phase 3 program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced CKD. ProKidney recently completed a comprehensive internal and external review, including engaging with ex-FDA officials and seasoned regulatory experts, to determine the optimal path to bring rilparencel to patients in the U.S. with type 2 diabetes and advanced CKD – a market where there is high unmet clinical and economic need. An important conclusion of this review is that under the provisions of the Regenerative Medicine Advanced Therapy (RMAT) designation, the Company believes rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon successful completion of the ongoing Phase 3 REGEN-006 (PROACT 1) trial. ProKidney believes that the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. registration. Thus, the Company will discontinue PROACT 2, which was focused on enrollment outside the U.S. With the discontinuation of PROACT 2, ProKidney now expects current cash to support operating plans into first quarter of 2027. The Company estimates the revised Phase 3 program will deliver topline results by third quarter 2027 and reduce expenses by approximately $150 to $175 million. Today’s update follows a transformational period for ProKidney over the past 10 months. In November 2023, Bruce Culleton, M.D., a nephrologist and seasoned leader of kidney care organizations, was appointed Chief Executive Officer. Under Dr. Culleton’s leadership, ProKidney has made significant progress, including the implementation of improved quality management systems to ensure compliance with global standards for commercial manufacturing and the Phase 3 program, the refinement and restart of the Phase 3 program with a renewed focus on patients with advanced CKD in the U.S., and the appointment of several key executive leaders across clinical operations, manufacturing, human resources, and business operations. The Company also released final data from the Phase 2 RMCL-002 trial and interim data from the Phase 2 REGEN-007 trial. Data from these trials suggest that rilparencel’s greatest potential therapeutic impact is in advanced CKD patients at high risk of kidney failure. This patient population aligns with feedback from payors and providers who have emphasized the need for treatment options in this population. Rilparencel was granted RMAT designation by the FDA in October 2021. RMAT designation can be granted to regenerative medicine therapies (including cell therapies) that are intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and have preliminary clinical evidence that indicate the drug candidate has the potential to address unmet medical needs for such disease or condition. This designation is intended to facilitate an accelerated development and review process similar to the breakthrough therapy designation. With an RMAT designation for rilparencel, ProKidney will continue to work with the FDA to receive guidance on its registrational program, including guidance on clinical trial design, manufacturing, and long-term patient follow-up, as appropriate. New Risk • Aug 05
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 22% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$56m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). New Risk • Jul 08
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 22% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$56m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). New Risk • Jul 01
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 22% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$56m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Aankondiging • Jun 18
ProKidney Corp. has completed a Follow-on Equity Offering in the amount of $26.693989 million. ProKidney Corp. has completed a Follow-on Equity Offering in the amount of $26.693989 million.
Security Name: Class A Ordinary Shares
Security Type: Common Stock
Securities Offered: 11,030,574
Price\Range: $2.42
Transaction Features: Registered Direct Offering New Risk • Jun 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 21% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$56m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Aankondiging • Jun 13
ProKidney Corp. Announces Positive Interim Regen-007 Phase 2 Trial Data and Provides Clinical and Operational Updates ProKidney Corp. announced positive interim results from the Phase 2 REGEN-007 trial evaluating the Company’s renal autologous cell therapy, rilparencel, in patients with CKD caused by diabetes and provided clinical and operational updates. Management will host a live webcast today at 8:00 a.m. ET to discuss the data. REGEN-007 Phase 2 Trial Interim Efficacy & Safety Data: REGEN-007 is an ongoing multi-center Phase 2 open-label 1:1 randomized two-armed trial in patients with diabetes and CKD who have an estimated glomerular filtration rate (eGFR) of 20 - 50 mL/min/1.73m². At randomization, patients are allocated to two treatment groups using different dosing regimens. Group 1 replicates the dosing schedule for our Phase 3 clinical study program in which patients receive two rilparencel injections – one in each kidney, three months apart. Group 2 tests an exploratory dosing regimen to investigate whether physiological triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients receive a single rilparencel dose in one kidney and a second dose in the contralateral kidney only if triggered by a sustained eGFR decline of = 20%, and/or an increase in the urine albumin to creatinine ratio (UACR) from baseline of = 30% and = 30 mg/g. In Group 1, as of May 7, 2024, patients with at least 12 months follow-up after the second injection of rilparencel (n=13) show stabilized kidney function for 18 months (average eGFR change from baseline to 18 months was -1.3 ml/min/1.73m2). Importantly, similar results were observed in a subset of these patients (n=10) who met key inclusion criteria currently used in our Phase 3 clinical study program (average eGFR change from baseline to 18 months was -0.6 ml/min/1.73m2). Additional analyses will be performed as Group 1 data matures. Twenty-five patients received at least one rilparencel injection in Group 2; 12 patients received a second rilparencel injection based on eGFR criteria (n=3) or UACR criteria (n=9). Patients in Group 2 who received two injections are scheduled to have up to 18 months of follow-up after their second injection. No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). Board Change • May 14
High number of new directors There are 6 new directors who have joined the board in the last 3 years. CEO & Director Bruce Culleton was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Apr 28
ProKidney Corp., Annual General Meeting, May 30, 2024 ProKidney Corp., Annual General Meeting, May 30, 2024, at 10:00 US Eastern Standard Time. Location: 399 Boylston Street, Ste. 350 Boston Massachusetts United States Agenda: To elect the following two director nominees named in this proxy statement to serve as class ii directors for three-year terms expiring at the annual general meeting in 2027 and until their successors are duly elected and qualified: jennifer fox and josé ignacio jiménez santos; to ratify the appointment of ernst & young llp as company's independent registered public accounting firm for the fiscal year ending december 31, 2024; and to transact such other business that is properly presented at the annual meeting and any adjournments or postponements thereof. Board Change • Apr 17
High number of new directors There are 6 new directors who have joined the board in the last 3 years. CEO & Director Bruce Culleton was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Mar 26
ProKidney Corp. Announces Key Leadership Appointments Strengthening Clinical and Technical Operations ProKidney Corp. announced two recent strategic appointments enhancing the leadership team’s expertise in clinical operations and technical operations, positioning the Company for completion of its Phase 3 program and future commercialization. Dr. Ulrich Ernst, PhD joins the Company as Executive Vice President of Technical Operations, and Mr. Lucio Tozzi was appointed Senior Vice President of Global Clinical Operations on January 22, 2024. Both Dr. Ernst and Mr. Tozzi and will be joining the ProKidney Executive Leadership Team. Dr. Ernst has over 30 years of experience in the biopharmaceutical industry with a focus on process development, manufacturing and facility oversight, and supply chain operations in the cell space. Prior to ProKidney, he led process development, and manufacturing of complex therapeutics, including autologous cell therapies and antibody-drug conjugates. Dr. Ernst was Senior Vice President of Technical Operations at Iovance Biotherapeutics, Chief Operating Officer at Amunix Operating Inc., and Senior Vice President of Manufacturing Operations at Cytovance Biologics. Dr. Ernst earned his PhD in chemical engineering at Lehigh University in Pennsylvania. Mr. Tozzi also brings over 30 years of experience in international drug development and execution of clinical trials across multiple therapeutic categories. He oversaw design and implementation of over 75 Phase 1-4 clinical studies in more than 65 countries in a variety of clinical indications, including kidney disease. Prior to ProKidney, Mr. Tozzi was Senior Vice President and Head of Clinical Operations at Summit Therapeutics and Rain Oncology, and, prior to that, Vice President of Clinical Operations at Protagonist Therapeutics. New Risk • Mar 24
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 25% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 25% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$41m net loss in 2 years). New Risk • Mar 17
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: Mex$1.58b (US$94.7m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$76m net loss in 2 years). Market cap is less than US$100m (Mex$1.58b market cap, or US$94.7m). Board Change • Mar 07
High number of new directors There are 6 new directors who have joined the board in the last 3 years. CEO & Director Bruce Culleton was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Jan 22
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: Mex$1.49b (US$87.3m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 39% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$76m net loss in 2 years). Market cap is less than US$100m (Mex$1.49b market cap, or US$87.3m). Board Change • Jan 18
High number of new directors There are 6 new directors who have joined the board in the last 3 years. CEO & Director Bruce Culleton was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Dec 26
High number of new directors There are 6 new directors who have joined the board in the last 3 years. CEO & Director Bruce Culleton was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Dec 01
ProKidney Corp. Announces Termination of Deepak Jain as Chief Operating Officer On November 28, 2023, ProKidney Corp. notified Deepak Jain, Ph.D., Chief Operating Officer of the Company, of the termination of his employment without cause, effective as of the same date, following which Dr. Jain is expected to continue to serve as a consultant to the Company. Aankondiging • Nov 30
Prokidney Appoints Nikhil Pereira-Kamath as Chief Business Officer ProKidney Corp. announced the appointment of Nikhil Pereira-Kamath, MBA, Vice President of Business Development & Innovative Solutions, to Chief Business Officer (CBO). As CBO, Nikhil will have global responsibility for commercial strategy, defining the Company’s growth and partnering activities, business development, and investor relations. Mr. Pereira-Kamath joined ProKidney earlier this year as Vice President of Business Development & Innovative Solutions, bringing with him over a decade of experience as a seasoned entrepreneur in addition to a strong foundation in finance. Prior to joining ProKidney, he was Chief Executive Officer and subsequently Executive Chairman, a role he continues to hold, of Africa Healthcare Network (AHN), the largest independent provider of dialysis and kidney care in sub-Saharan Africa. Mr. Pereira-Kamath co-founded AHN in 2015 where he built the organization to over 500 employees at 45 dialysis centers across four countries in sub-Saharan Africa. Mr. Pereira-Kamath started his career as an analyst at Morgan Stanley in its Healthcare Investment Banking division covering large pharma, biotech and pharma services. Following that, he worked at Berkshire Partners, a multi-sector specialist investor in private and public equity, where he focused on investing in and growing companies across communications & digital infrastructure, healthcare, consumer, services & industrials and technology. Mr. Pereira-Kamath received his B.A. in Economics with a Certificate in Finance from Princeton University and his MBA from Harvard Business School. He is a member of the International Society of Nephrology’s inaugural Emerging Leaders Program and is an Endeavor Entrepreneur. Aankondiging • Nov 21
ProKidney Corp. (NasdaqCM:PROK) announces an Equity Buyback for 7,256,367 shares, for $9.5 million. ProKidney Corp. (NasdaqCM:PROK) announces a share repurchase program. Under the program, the company will repurchase up to 7,256,367 Class A ordinary shares for a total of $9.5 million. The shares will be repurchased at a purchase price of $1.309 per share. The shares will be repurchased from SC PIPE Holdings LLC and SC Master Holdings, LLC (the “Selling Shareholders”). The share repurchase is expected to close on November 21, 2023. Board Change • Nov 17
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Jennifer Fox was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Nov 15
ProKidney Corp. Announces Executive Changes ProKidney Corp. announced Dr. Bruce Culleton, EVP Clinical Development and Commercialization, to be appointed the company CEO upon Dr. Tim Bertram’s transition to an advisory role. As the Company progresses into pivotal development and commercialization, the company announce the appointment of Dr. Bruce Culleton as the Company’s CEO, effective November 15, 2023. Dr. Culleton will also join the company board of directors. Dr. Tim Bertram will transition from his current role as director and CEO to a scientific advisory role. Dr. Culleton joined the company in July 2023 as Executive Vice President of Clinical Development and Commercialization. Dr. Culleton has dedicated his 25-year professional career to improving the health and quality of life of patients with kidney disease. Over this time his responsibilities have included direct patient care, clinical research, product development, and executive leadership positions at Baxter Healthcare and CVS Kidney Care, a wholly owned subsidiary of CVS Health. Dr. Culleton earned a Doctor of Medicine degree from Memorial University of Newfoundland, and a Master’s Degree in Business Administration from Northwestern University, Kellogg School of Management. He completed specialization in Internal Medicine and Nephrology through the Royal College of Physicians and Surgeons of Canada, as well as a fellowship in Clinical Epidemiology at Boston University, Framingham Heart Study. Board Change • Oct 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Jennifer Fox was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Valuation Update With 7 Day Price Move • Sep 24
Investor sentiment deteriorates as stock falls 40% After last week's 40% share price decline to Mex$83.50, the stock trades at a trailing P/E ratio of 5.3x. Average forward P/E is 24x in the Biotechs industry globally. Valuation Update With 7 Day Price Move • Sep 09
Investor sentiment deteriorates as stock falls 17% After last week's 17% share price decline to Mex$139, the stock trades at a trailing P/E ratio of 8.8x. Average forward P/E is 24x in the Biotechs industry globally. Simply Wall St's valuation model estimates the intrinsic value at Mex$234 per share. Board Change • Sep 07
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Jennifer Fox was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Aug 19
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 4.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 4.2% per year for the foreseeable future. High level of non-cash earnings (927% accrual ratio). Revenue is less than US$1m. Board Change • Aug 18
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Jennifer Fox was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Jul 18
ProKidney Corp. Announces the Appointment of Bruce Culleton, MD, as Executive Vice President, Clinical Development and Commercialization ProKidney Corp. announced the appointment of Bruce Culleton, MD, as Executive Vice President, Clinical Development and Commercialization. Dr. Culleton, who will report to Chief Executive Officer Tim Bertram, joins ProKidney after more than two decades in industry and academia with a primary focus on kidney health. Dr. Culleton joins ProKidney from CVS Kidney Care, a wholly owned subsidiary of CVS Health, where he was most recently Vice President and General Manager. Previously, he served as Vice President and Chief Medical Officer at CVS Kidney Care. Before joining CVS Health, he was Vice President, Global Clinical Development and World Wide Vice President, Medical Affairs, Medication and Procedural Solutions at Becton Dickinson; and previously Vice President, Renal Therapeutic Area at Baxter Healthcare. Prior to beginning his industry career in 2007, Dr. Culleton was a Clinical Associate Professor, Department of Medicine at the University of Calgary. Dr. Culleton holds a Bachelors degree in Medical Science and a Doctor of Medicine degree from Memorial University of Newfoundland; and a Masters degree in Business Administration from Northwestern University, Kellogg School of Management. He completed a specialization in Internal Medicine and Nephrology through the Royal College of Physicians and Surgeons of Canada, as well as a fellowship in Clinical Epidemiology at Boston University, Framingham Heart Study. Aankondiging • May 27
ProKidney Corp., Annual General Meeting, Jun 29, 2023 ProKidney Corp., Annual General Meeting, Jun 29, 2023, at 10:00 US Eastern Standard Time. Location: Unit 5-205, Governors Square Boardroom, 23 Lime Tree Bay Avenue, West Bay Grand Cayman Cayman Islands Agenda: To consider directorate elections; to ratify the appointment of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2023; and to transact such other business that is properly presented at the annual meeting and any adjournments or postponements thereof. Aankondiging • Feb 07
Libbie McKenzie Resigns from Prokidney as Chief Medical Officer Dr. Libbie McKenzie has resigned from ProKidney as Chief Medical Officer and will be pursuing other opportunities that align with her objectives.