<p>2025 年 11 月 05 日- 上午 09:15</p>
<p>佛罗里达州维罗海滩，2025 年 11 月 05 日（全球新闻稿）——Processa Pharmaceuticals, Inc.（纳斯达克：PCSA）是一家临床阶段的生物制药公司，专注于开发下一代癌症（NGC）疗法和创新的罕见疾病治疗方案，今天宣布其摘要《针对局灶性节段性肾小管硬化症（FSGS）患者的 PCS499（499）适应性 2/3 期研究》已被接受在 2025 年美国肾脏学会（ASN）肾脏周刊上进行展示，会议将于 2025 年 11 月 5 日至 9 日在德克萨斯州休斯顿举行。</p>
<p>该海报将作为 “肾小管临床试验：从数据到影响” 会议的一部分，于 2025 年 11 月 7 日（星期五）中部时间上午 10:00 至 12:00 进行展示。海报编号为 FR-PO0829。</p>
<p>PCS499 是五氟嘧啶（PTX）代谢物的类似物。临床研究表明，PTX 可以减少慢性肾病（CKD）患者的蛋白尿，但剂量限制性副作用限制了其使用。PCS499 在安全性方面表现出优于 PTX 的特征，允许更高的剂量，并可能在如 FSGS 等罕见肾病中带来更大的治疗益处，FSGS 是一种治疗选择有限的严重疾病。Processa 将在今年晚些时候与 FDA 讨论的适应性 2/3 期设计，旨在优化剂量并加速监管批准的进程。</p>
<p>“我们很荣幸能在 ASN 肾脏周刊上展示我们的 PCS499 项目，这是推动肾脏疾病研究和患者护理的首要论坛，” Processa Pharmaceuticals 研发总裁 David Young 博士表示。“这项适应性 2/3 期研究是解决 FSGS 患者迫切需要更安全、更有效疗法的关键一步。我们相信 PCS499 有潜力显著改善这一服务不足人群的患者结果。”</p>
<p><strong>关于 FSGS</strong></p>
<p>局灶性节段性肾小管硬化症是一种罕见的进行性肾脏疾病，其特征是肾脏过滤单元的瘢痕，常常导致终末期肾病。目前没有 FDA 批准的专门针对 FSGS 的疗法，突显了对新治疗选择的迫切需求。</p>
<p><strong>关于 Processa Pharmaceuticals, Inc.</strong></p>
<p>Processa 是一家临床阶段的制药公司，专注于开发具有改进安全性和疗效的下一代癌症（NGC）药物。Processa 的 NGC 药物是现有 FDA 批准的肿瘤治疗药物的改良版，旨在改变这些药物的代谢和/或分布，同时保持现有的杀伤癌细胞机制。通过将其新颖的肿瘤学管线与经过验证的抗癌活性分子及其监管科学方法相结合，Processa 的战略是通过高效的监管路径开发更有效的治疗选择，以提高癌症患者的耐受性。除了核心肿瘤学项目外，Processa 还积极寻求非肿瘤资产的战略合作伙伴关系，以释放额外价值。</p>
<p>欲了解更多信息，请访问我们的网站 www.processapharma.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本发布包含前瞻性声明。本新闻稿中非纯历史性的声明为前瞻性声明，涉及风险和不确定性。实际未来的表现结果可能与前瞻性声明中表达的结果有实质性差异。请参阅 Processa Pharmaceuticals 向 SEC 提交的文件，特别是最近的 10-K 和 10-Q 表格报告，其中识别了可能导致实际结果与前瞻性声明中包含的结果不同的重要风险因素。</p>
<p><strong>公司联系方式：</strong></p>
<p>Patrick Lin</p>
<p>(925) 683-3218</p>
<p>plin@processapharma.com</p>
<p><strong>投资者关系：</strong></p>
<p>Dave Gentry</p>
<p>RedChip Companies, Inc.</p>
<p>1-407-644-4256</p>
<p>PCSA@redchip.com</p>
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PCSA

<p>Processa Pharmaceuticals, Inc.（纳斯达克代码：PCSA）宣布，其关于 PCS499 在局灶性节段性肾小管硬化症（FSGS）患者中的适应性 2/3 期研究的摘要已被接受，在 2025 年 11 月 7 日于德克萨斯州休斯顿的 ASN Kidney Week 2025 上进行展示。PCS499 是一种类黄嘌呤的药物，旨在为 FSGS 提供一种更安全、更有效的治疗选择，这是一种没有 FDA 批准疗法的罕见肾病。该研究代表了向监管批准和改善患者结果的重要一步</p>

<p>11/05/2025 - 09:15 AM</p>
<div class="lb-trans"><p>2025 年 11 月 05 日- 上午 09:15</p>
</div><p>VERO BEACH, Fla., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies and innovative treatments for rare diseases, today announced that its abstract, <em>“Adaptive Phase 2/3 Study for PCS499 (499) in Patients with Focal Segmental Glomerulosclerosis (FSGS)”</em>, has been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2025, taking place November 5–9, 2025, in Houston, Texas.</p>
<div class="lb-trans"><p>佛罗里达州维罗海滩，2025 年 11 月 05 日（全球新闻稿）——Processa Pharmaceuticals, Inc.（纳斯达克：PCSA）是一家临床阶段的生物制药公司，专注于开发下一代癌症（NGC）疗法和创新的罕见疾病治疗方案，今天宣布其摘要《针对局灶性节段性肾小管硬化症（FSGS）患者的 PCS499（499）适应性 2/3 期研究》已被接受在 2025 年美国肾脏学会（ASN）肾脏周刊上进行展示，会议将于 2025 年 11 月 5 日至 9 日在德克萨斯州休斯顿举行。</p>
</div><p>The poster will be presented as part of the session <em>“Glomerular Clinical Trials: From Data to Impact”</em> on Friday, November 7, 2025, from 10:00 a.m. to 12:00 p.m. Central Time. The poster board number is FR-PO0829.</p>
<div class="lb-trans"><p>该海报将作为 “肾小管临床试验：从数据到影响” 会议的一部分，于 2025 年 11 月 7 日（星期五）中部时间上午 10:00 至 12:00 进行展示。海报编号为 FR-PO0829。</p>
</div><p>PCS499 is an analog of a metabolite of pentoxifylline (PTX). PTX has been shown to decrease proteinuria in clinical studies with CKD patients but the dose limiting side effects limits its use. PCS499 has demonstrated a favorable safety profile over PTX allowing for a higher dose and potentially greater therapeutic benefit in rare kidney diseases such as FSGS, a serious condition with limited treatment options. The adaptive Phase 2/3 design that Processa will be discussing with FDA later this year and presenting at ASN aims to optimize dosing and accelerate the path toward regulatory approval.</p>
<div class="lb-trans"><p>PCS499 是五氟嘧啶（PTX）代谢物的类似物。临床研究表明，PTX 可以减少慢性肾病（CKD）患者的蛋白尿，但剂量限制性副作用限制了其使用。PCS499 在安全性方面表现出优于 PTX 的特征，允许更高的剂量，并可能在如 FSGS 等罕见肾病中带来更大的治疗益处，FSGS 是一种治疗选择有限的严重疾病。Processa 将在今年晚些时候与 FDA 讨论的适应性 2/3 期设计，旨在优化剂量并加速监管批准的进程。</p>
</div><p>“We are honored to present our PCS499 program at ASN Kidney Week, the premier forum for advancing kidney disease research and patient care,” said David Young, Pharm.D., Ph.D., President of Research and Development at Processa Pharmaceuticals. “This adaptive Phase 2/3 study represents a critical step in addressing the urgent need for safer, more effective therapies for patients with FSGS. We believe PCS499 has the potential to significantly improve patient outcomes in this underserved population.”</p>
<div class="lb-trans"><p>“我们很荣幸能在 ASN 肾脏周刊上展示我们的 PCS499 项目，这是推动肾脏疾病研究和患者护理的首要论坛，” Processa Pharmaceuticals 研发总裁 David Young 博士表示。“这项适应性 2/3 期研究是解决 FSGS 患者迫切需要更安全、更有效疗法的关键一步。我们相信 PCS499 有潜力显著改善这一服务不足人群的患者结果。”</p>
</div><p><strong>About FSGS</strong></p>
<div class="lb-trans"><p><strong>关于 FSGS</strong></p>
</div><p>Focal Segmental Glomerulosclerosis is a rare, progressive kidney disease characterized by scarring in the kidney’s filtering units, often leading to end-stage renal disease. There are currently no FDA-approved therapies specifically indicated for FSGS, underscoring the urgent need for new treatment options.</p>
<div class="lb-trans"><p>局灶性节段性肾小管硬化症是一种罕见的进行性肾脏疾病，其特征是肾脏过滤单元的瘢痕，常常导致终末期肾病。目前没有 FDA 批准的专门针对 FSGS 的疗法，突显了对新治疗选择的迫切需求。</p>
</div><p><strong>About Processa Pharmaceuticals, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 Processa Pharmaceuticals, Inc.</strong></p>
</div><p>Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value</p>
<div class="lb-trans"><p>Processa 是一家临床阶段的制药公司，专注于开发具有改进安全性和疗效的下一代癌症（NGC）药物。Processa 的 NGC 药物是现有 FDA 批准的肿瘤治疗药物的改良版，旨在改变这些药物的代谢和/或分布，同时保持现有的杀伤癌细胞机制。通过将其新颖的肿瘤学管线与经过验证的抗癌活性分子及其监管科学方法相结合，Processa 的战略是通过高效的监管路径开发更有效的治疗选择，以提高癌症患者的耐受性。除了核心肿瘤学项目外，Processa 还积极寻求非肿瘤资产的战略合作伙伴关系，以释放额外价值。</p>
</div><p>For more information, visit our website at www.processapharma.com.</p>
<div class="lb-trans"><p>欲了解更多信息，请访问我们的网站 www.processapharma.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.</p>
<div class="lb-trans"><p>本发布包含前瞻性声明。本新闻稿中非纯历史性的声明为前瞻性声明，涉及风险和不确定性。实际未来的表现结果可能与前瞻性声明中表达的结果有实质性差异。请参阅 Processa Pharmaceuticals 向 SEC 提交的文件，特别是最近的 10-K 和 10-Q 表格报告，其中识别了可能导致实际结果与前瞻性声明中包含的结果不同的重要风险因素。</p>
</div><p><strong>CompanyContact:</strong></p>
<div class="lb-trans"><p><strong>公司联系方式：</strong></p>
</div><p>Patrick Lin</p>
<div class="lb-trans"><p>Patrick Lin</p>
</div><p>(925) 683-3218</p>
<div class="lb-trans"><p>(925) 683-3218</p>
</div><p>plin@processapharma.com</p>
<div class="lb-trans"><p>plin@processapharma.com</p>
</div><p><strong>Investor Relations:</strong></p>
<div class="lb-trans"><p><strong>投资者关系：</strong></p>
</div><p>Dave Gentry</p>
<div class="lb-trans"><p>Dave Gentry</p>
</div><p>RedChip Companies, Inc.</p>
<div class="lb-trans"><p>RedChip Companies, Inc.</p>
</div><p>1-407-644-4256</p>
<div class="lb-trans"><p>1-407-644-4256</p>
</div><p>PCSA@redchip.com</p>
<div class="lb-trans"><p>PCSA@redchip.com</p>
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Processa Pharmaceuticals 宣布将在 2025 年 ASN 肾脏周上展示关于 FSGS 的自适应 2/3 期 PCS499 研究的海报 | PCSA 股票新闻