U.S. FDA clears IND for Phase 2 study of VT-7208 in chronic spontaneous urticaria; additional Phase 2 studies planned in food allergy and relapsing multiple sclerosis

美国FDA批准VT-7208用于治疗慢性自发性荨麻疹的II期临床试验的IND申请；计划在食物过敏和复发型多发性硬化症中开展额外的II期研究

Company expands pipeline through research collaboration of a novel, oral macrocyclic peptide-based neonatal Fc receptor antagonist program from Generian Pharmaceuticals

公司通过与Generian Pharmaceuticals就一种新型口服大环肽类新生儿Fc受体拮抗剂项目开展研发合作，扩充其产品管线

Sheila Gujrathi, M.D., appointed Executive Chair of Processa’s Board of Directors

希拉·古杰拉蒂（Sheila Gujrathi）医学博士被任命为 Processa 董事会执行主席

Cash runway expected to fund operations into the second half of 2029

现金跑道预计可支持公司运营至2029年下半年

VERO BEACH, FL, Oct. 29, 2026 (GLOBE NEWSWIRE) --

佛罗里达州维罗海滩，2026年10月29日（环球新闻社）--

Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company developing VT-7208, a Bruton's tyrosine kinase (BTK) inhibitor therapy for immune-mediated diseases, today announced continued execution following its acquisition of Vidya Therapeutics (“Vidya”).

Processa Pharmaceuticals, Inc.（纳斯达克股票代码：PCSA）（“Processa”或“公司”）是一家临床阶段制药公司，正在开发VT-7208，一种用于治疗免疫介导疾病的布鲁顿酪氨酸激酶（BTK）抑制剂疗法。该公司今日宣布，在完成对Vidya Therapeutics（“Vidya”）的收购后，持续推动相关业务执行。

Progress includes U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) application for a Phase 2 study of VT-7208 in chronic spontaneous urticaria (CSU), expansion of the pipeline through a research collaboration with Generian Pharmaceuticals, and the appointment of Sheila Gujrathi, M.D., as Executive Chair of the Board of Directors..

进展包括：美国食品药品监督管理局（FDA）批准了VT-7208用于慢性自发性荨麻疹（CSU）的II期临床试验的新药研究（IND）申请；通过与Generian Pharmaceuticals的研究合作扩展产品管线；以及任命Sheila Gujrathi博士为董事会执行主席。

Processa is advancing VT-7208, a next-generation, CNS-penetrant, once-daily oral BTK inhibitor, across three Phase 2 proof-of-concept programs, including CSU, food allergy and relapsing multiple sclerosis. These programs provide multiple opportunities to evaluate VT-7208 across distinct immune-mediated diseases.

Processa 正在推进 VT-7208 的研发，这是一种下一代、可穿透中枢神经系统、每日一次口服的 BTK 抑制剂，目前正处于三项 II 期概念验证临床试验中，涵盖慢性自发性荨麻疹（CSU）、食物过敏和复发型多发性硬化症。这些项目为在不同免疫介导疾病中评估 VT-7208 提供了多重机会。

The acquisition was accompanied by an approximately $200 million private placement from leading institutional healthcare investors. The Company expects its current cash resources to support operations into the second half of 2029..

此次收购伴随来自领先机构医疗健康投资者的大约2亿美元的私募配售。公司预计其现有现金资源可支持运营至2029年下半年。

“Since the Vidya transaction, we have made great progress in executing our strategy,” said Dr. Gujrathi. “The FDA clearance of the CSU IND is an exciting step toward advancing VT-7208 across three planned Phase 2 programs. At the same time, the Generian collaboration expands our pipeline around another high-value, clinically validated immune target.

“自Vidya交易以来，我们在执行战略方面取得了重大进展，”Gujrathi博士表示。“CSU IND获得FDA批准是推进VT-7208在三个计划中的II期临床试验的重要一步。与此同时，与Generian的合作围绕另一个高价值、临床验证的免疫靶点扩展了我们的产品线。”

With funding in place to support these programs, our focus is on disciplined execution and generating the data needed to demonstrate the potential of the portfolio.”.

随着支持这些项目的资金到位，我们的重点是严格执行并生成所需数据，以展示产品组合的潜力。

“Sheila has been an invaluable partner to the Board since the Vidya transaction, and her experience building biotechnology companies, advancing clinical programs and creating long-term value makes her well suited to lead the Board through this next phase,” said Justin Yorke, former Chair of the Processa Board of Directors.

“自Vidya交易以来，希拉一直是董事会不可或缺的合作伙伴，她在建立生物技术公司、推进临床项目以及创造长期价值方面的经验，使她非常适合带领董事会进入下一个阶段。”前Processa董事会主席贾斯汀·约克表示。

“We are pleased to have her step into the Executive Chair role as Processa advances its clinical strategy and broader pipeline.”.

“我们很高兴她出任执行主席一职，助力 Processa 推进其临床战略及更广泛的产品管线。”

FDA Clears IND for Phase 2 Study of VT-7208 in CSU

FDA批准VT-7208用于慢性自发性荨麻疹（CSU）的II期临床试验的IND申请

The FDA has cleared the IND application for VT-7208 in CSU, enabling Processa to advance the program into a Phase 2 study in adults with moderate-to-severe disease.

美国食品药品监督管理局（FDA）已批准VT-7208用于慢性自发性荨麻疹（CSU）的临床试验申请（IND），使Processa公司能够推进该项目，在中重度疾病的成年患者中开展II期临床研究。

The planned multicenter, randomized, double-blind, placebo-controlled study is expected to enroll approximately 120 adults whose disease is not adequately controlled with H1 antihistamines. The study will evaluate VT-7208 versus placebo over 12 weeks and assess efficacy, safety, tolerability and pharmacologic activity..

这项计划中的多中心、随机、双盲、安慰剂对照研究预计将招募约120名使用H1抗组胺药病情控制不佳的成年患者。该研究将在12周内评估VT-7208与安慰剂的对比效果，并评价其疗效、安全性、耐受性和药理活性。

CSU is a chronic inflammatory disease characterized by recurrent hives, swelling or both without an identifiable external trigger and affects an estimated 1.6 to 2 million U.S. adults. Despite available therapies, a meaningful proportion of patients remain inadequately controlled, underscoring the need for additional treatment options..

慢性自发性荨麻疹（CSU）是一种慢性炎症性疾病，其特征为在无明确外部诱因的情况下反复发作的风团、血管性水肿或两者兼有，估计影响160万至200万美国成年人。尽管已有可用疗法，仍有相当比例的患者病情控制不佳，这凸显了对额外治疗选择的需求。

Pipeline Expansion Through Research Collaboration

通过研究合作拓展产品线

Processa also announced that it has entered into a research collaboration and exclusive option agreement with Generian Pharmaceuticals, a UPMC Enterprises portfolio company that emerged from the UPMC/University of Pittsburgh ecosystem for breakthrough science, to advance a novel oral macrocyclic peptide-based neonatal Fc receptor (FcRn) antagonist program, further expanding Processa’s immunology pipeline..

Processa还宣布，已与Generian Pharmaceuticals达成研究合作及独家选择权协议。Generian Pharmaceuticals是UPMC Enterprises旗下的一家投资组合公司，源自UPMC/匹兹堡大学突破性科学生态系统。双方将共同推进一种新型基于大环肽的口服新生儿Fc受体（FcRn）拮抗剂项目，进一步拓展Processa在免疫学领域的产品管线。

The collaboration targets a clinically validated mechanism for treating IgG-mediated autoimmune diseases and supports the companies’ shared strategy of developing differentiated oral therapeutic alternatives to currently available injectable FcRn therapies. The program complements VT-7208 and reflects Processa’s broader strategy to selectively expand its pipeline around clinically validated immune targets, using capital-efficient structures that provide access to novel programs while preserving flexibility as the science matures..

此次合作针对的是经临床验证的治疗IgG介导的自身免疫性疾病的机制，并支持两家公司共同开发差异化的口服治疗药物，以替代目前可用的注射型FcRn疗法的战略。该项目是对VT-7208的补充，也体现了Processa更广泛的战略，即围绕经临床验证的免疫靶点选择性扩展其产品管线，采用资本效率高的合作结构，在科学逐步成熟的过程中既能够获取创新项目，又保持灵活性。

Sheila Gujrathi Appointed Executive Chair

希拉·古杰拉蒂被任命为执行主席

Dr. Gujrathi has been appointed Executive Chair of the Processa Board of Directors. She has served on the Board since Processa’s acquisition of Vidya in June 2026, where she was founder and its executive chair. In this expanded role, she will support the management team on corporate strategy, capital allocation and organizational development..

古吉拉蒂博士已被任命为Processa董事会的执行主席。自2026年6月Processa收购Vidya以来，她一直在董事会任职，此前她是Vidya的创始人兼执行主席。在这一扩展的角色中，她将支持管理团队制定公司战略、资本配置和组织发展。

Dr. Gujrathi is a physician-scientist, biotechnology entrepreneur and drug developer with extensive experience building biotechnology companies and advancing therapies in immunology. Her prior leadership roles include Executive Chair of Ventyx Biosciences, Chair of Turning Point Therapeutics, Chair of ADARx Pharmaceuticals, co-founder and Chief Executive Officer of Gossamer Bio, and Chief Medical Officer of Receptos..

古杰拉蒂博士是一位医师科学家、生物技术企业家和药物研发专家，在创建生物技术公司和推进免疫学疗法方面拥有丰富经验。她此前担任的领导职务包括：Ventyx Biosciences 执行主席、Turning Point Therapeutics 主席、ADARx Pharmaceuticals 主席、Gossamer Bio 联合创始人兼首席执行官，以及 Receptos 首席医疗官。

ABOUT PROCESSA PHARMACEUTICALS

关于Processa Pharmaceuticals

Processa Pharmaceuticals is a clinical-stage pharmaceutical company advancing innovative drug candidates through a disciplined, science-driven development strategy. Following the acquisition of Vidya Therapeutics, Processa’s lead program is VT-7208, a Bruton's tyrosine kinase (BTK) inhibitor therapy for immune-mediated diseases.

Processa Pharmaceuticals 是一家处于临床阶段的制药公司，通过严谨的、以科学为驱动的开发策略推进创新药物候选项目。在收购 Vidya Therapeutics 之后，Processa 的核心项目是 VT-7208，一种用于免疫介导疾病的布鲁顿酪氨酸激酶（BTK）抑制剂疗法。

VT-7208 is a potentially best-in-class BTK inhibitor (BTKi) designed to improve on the efficacy and safety of early-generation programs. Processa is developing VT-7208 in three parallel programs: food allergy and chronic spontaneous urticaria (CSU) in immunology, and relapsing multiple sclerosis (RMS) in neurology, where its CNS-penetrant profile addresses an area of high unmet need.

VT-7208 是一款潜在的同类最佳 BTK 抑制剂（BTKi），旨在提升早期研发项目在疗效和安全性方面的表现。Processa 正在三个平行项目中开发 VT-7208：免疫学领域的食物过敏和慢性自发性荨麻疹（CSU），以及神经病学领域的复发型多发性硬化症（RMS），其中枢神经系统渗透特性可满足该领域高度未竟的医疗需求。

With Phase 1 complete, the company intends to advance all three programs toward Phase 2 proof-of-concept studies. .

随着第一阶段完成，公司计划推进所有三个项目进入第二阶段的概念验证研究。

FORWARD-LOOKING STATEMENTS

前瞻性陈述

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, concerning Processa, Vidya, the concurrent private placement financing and the acquisition of Vidya by Processa (the “Transactions”) and other matters.

本新闻稿中除纯粹的历史信息外，某些陈述可能构成联邦证券法律意义上的“前瞻性陈述”，包括根据1995年美国《私人证券诉讼改革法》的安全港条款所涵盖的关于Processa、Vidya、同步进行的私募融资以及Processa收购Vidya（统称“交易”）及其他事项的陈述。

These forward-looking statements include, but are not limited to, express or implied statements relating to the company’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the Transactions and the expected effects, perceived benefits or opportunities and related timing with respect to the Transactions; expectations regarding or plans for VT-7208, including its planned clinical trials, research and development programs and the expected timing for key milestones; the potential benefits of VT-7208 and other clinical and preclinical programs; the perceived benefits of the research collaboration and exclusive option agreement with Generian Pharmaceuticals; and expectations regarding the use of proceeds from the concurrent private placement financing and cash runway expectations therefrom, including such proceeds funding the company into the second half of 2029.

这些前瞻性陈述包括但不限于，与公司关于未来的预期、希望、信念、意图或战略相关的明示或暗示性陈述，包括但不限于以下方面的陈述：交易及其预期影响、感知到的益处或机会以及与交易相关的时间安排；对VT-7208的预期或计划，包括其计划的临床试验、研发项目以及关键里程碑的预期时间安排；VT-7208及其他临床和临床前项目的潜在益处；与Generian Pharmaceuticals达成的研究合作及独家选择权协议的感知益处；以及对同步进行的私募融资所得款项用途的预期，由此产生的现金跑道预期，包括该等所得款项为公司提供资金直至2029年下半年。

In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “aim,” “strategy,” “target,” “seek,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate.

此外，任何提及预测、预估或对未来事件或情况的其他描述（包括任何基本假设）的陈述均属于前瞻性陈述。这些词语包括“机会”、“潜力”、“里程碑”、“管线”、“能够”、“目标”、“旨在”、“战略”、“指标”、“寻求”、“预期”、“实现”、“相信”、“考虑”、“继续”、“可能”、“估计”。

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