Dr. Ulrich Ernst joins as Executive Vice President of Technical Operations with a deep background and expertise in process development and manufacturing of cell therapies

Ulrich Ernst博士担任技术运营执行副总裁，在细胞疗法的过程开发和制造方面具有深厚的背景和专业知识

Mr. Lucio Tozzi joined in January of 2024 as Senior Vice President of Global Clinical Operations having over 30 years of experience in clinical trial execution

卢西奥·托齐先生于2024年1月加入，担任全球临床运营高级副总裁，拥有30多年的临床试验执行经验

WINSTON-SALEM, N.C., March 25, 2024 (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 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.

WINSTON-SALEM，N.C.，2024年3月25日（环球通讯社）--ProKidney Corp.（纳斯达克：PROK）（“ProKidney”或“公司”），一家专注于慢性肾脏病（CKD）的领先临床晚期细胞治疗公司，今天宣布了最近的两项战略任命，以增强领导团队在临床操作和技术操作方面的专业知识，为公司完成第三阶段计划和未来商业化奠定基础。

Dr. Ulrich Ernst, PhD joins the Company today 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..

Ulrich Ernst博士今天加入公司，担任技术运营执行副总裁，Lucio Tozzi先生于2024年1月22日被任命为全球临床运营高级副总裁。Ernst博士和Tozzi先生都将加入Prorend执行领导团队。。

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.

Ernst博士在生物制药行业拥有30多年的经验，专注于过程开发，制造和设施监督以及细胞空间的供应链运营。在ProKidney之前，他领导了复杂疗法的工艺开发和制造，包括自体细胞疗法和抗体-药物偶联物。

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..

Ernst博士曾任Iovance Biotherapeutics技术运营高级副总裁、Amunix Operating Inc.首席运营官和Cytovance Biologics制造运营高级副总裁。Ernst博士在宾夕法尼亚州Lehigh大学获得化学工程博士学位。。

“Dr. Ernst’s expertise in bringing complex process operations through to commercialization and his track record of gaining manufacturing facility approvals and new market authorizations will be invaluable as we progress our Phase 3 program and prepare for BLA submission,” said Dr. Bruce Culleton, Chief Executive Officer of ProKidney..

ProKidney首席执行官布鲁斯·库尔顿（BruceCulleton）博士表示：“随着我们推进第三阶段计划并准备提交BLA，恩斯特博士在将复杂工艺操作商业化方面的专业知识以及他获得制造设施批准和新市场授权的记录将是非常宝贵的。”。。

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.

托齐先生在国际药物开发和多个治疗类别的临床试验执行方面也拥有30多年的经验。他在65多个国家监督了包括肾脏疾病在内的各种临床适应症的75多项1-4期临床研究的设计和实施。

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..

在ProKidney之前，Tozzi先生是Summit Therapeutics和Rain Oncology的高级副总裁兼临床运营主管，在此之前，他是Protagent Therapeutics的临床运营副总裁。。

Dr. Culleton continued, “Mr. Tozzi’s extensive background in clinical trial execution has been and will continue to be integral in the coming months for the enrollment of patients in PROACT 1 and PROACT 2. I am pleased to have these seasoned industry veterans join our Executive Leadership Team. They bring critically important experience that strengthens our ability to execute on our late-stage clinical program and prepare the organization for future commercialization of rilparencel.”.

Culleton博士继续说道：“托齐先生在临床试验执行方面的广泛背景已经并将继续成为未来几个月PROACT 1和PROACT 2患者注册的组成部分。我很高兴有这些经验丰富的行业老手加入我们的执行领导团队。他们带来了至关重要的经验，增强了我们执行晚期临床计划的能力，并为rilparencel的未来商业化做好了准备。”。

About ProKidney

关于原肾

ProKidney, a pioneer in the treatment of CKD 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-of-its-kind, patented, proprietary autologous cellular therapy being evaluated to potentially preserve kidney function in diabetic patients at high risk of kidney failure.

ProKidney是通过细胞疗法创新治疗CKD的先驱，经过十年的研究，于2015年成立。ProKidney的主要候选产品rilparencel（也称为REACT®）是首例获得专利的专有自体细胞疗法，正在评估其可能保护肾衰竭高危糖尿病患者的肾功能。

Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program that launched in January 2022. For more information, please visit www.prokidney.com..

Rilparencel已获得再生医学高级治疗（RMAT）的指定，以及FDA和EMA的指导，支持其正在进行的2022年1月启动的3期临床计划。有关更多信息，请访问www.prokidney.com。。

Forward-Looking Statements

前瞻性声明

This 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.

本新闻稿包括1995年《私人证券诉讼改革法案》中“安全港”条款所指的“前瞻性声明”。ProKidney的实际结果可能与其预期、估计和预测不同，因此，您不应将这些前瞻性陈述视为对未来事件的预测。

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.

诸如“预期”、“估计”、“项目”、“预算”、“预测”、“预期”、“打算”、“计划”、“可能”、“会”、“可能”、“应该”、“相信”、“预测”、“潜在”、“继续”等词语以及类似表达（或此类词语或表达的负面版本）旨在识别此类前瞻性陈述。

These forward-looking statements include, without limitation, the Company’s expectations with respect to financial results and expected cash runway, 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, updating clinical trial protocols, or achieving other milestones related to the Company’s product candidates, and the advancement and funding of the Company’s developmental programs generally.

这些前瞻性报表包括但不限于公司对财务业绩和预期现金流的预期、未来业绩、产品开发和商业化（如果获得批准）、公司产品的潜在利益和影响（如果获得批准）、潜在的监管批准、公司产品当前或未来市场的规模和潜在增长（如果获得批准）、公司开发计划进入诊所和通过诊所的进展以及报告数据的预期时间、监管文件的编制、临床试验方案的更新或实现与公司候选产品相关的其他里程碑，以及公司开发计划的推进和资金筹措。

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: the inability to maintain the listing of the Company’s Class A ordinary shares on the Nasdaq; the inability to implement business plans, forecasts, and other expectation.

这些因素大多超出了公司的控制范围，难以预测。可能导致此类差异的因素包括但不限于：无法维持公司A类普通股在纳斯达克的上市；无法实施商业计划、预测和其他期望。

Contacts

联系人

Investors:

投资者：

LifeSci Advisors, LLC

LifeSci Advisors有限责任公司

Daniel Ferry

丹尼尔·费里

Daniel@lifesciadvisors.com

Daniel@lifesciadvisors.com