HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that, as previously disclosed, Arun Swaminathan, Ph.D., has been promoted to Chief Executive Officer, effective today, November 1, 2024.

休斯顿——（商业新闻短讯）——Coya Therapeutics，Inc.（纳斯达克：Coya）（“Coya”或“公司”）是一家临床阶段的生物技术公司，开发旨在增强调节性T细胞（Treg）功能的生物制剂，宣布，如前所述，Arun Swaminathan博士已晋升为首席执行官，于2024年11月1日生效。

Dr. Swaminathan was instrumental in executing several significant commercial transactions in his career, including Coya’s licensing transaction with Dr. Reddy’s Laboratory in December 2023 that could be worth up to $700 million if all milestones are met. He brings a wealth of strategic, business development, operational, and deal-making experience to help guide Coya in its next phase of corporate growth..

斯瓦米纳坦博士在其职业生涯中参与了几笔重要的商业交易，包括2023年12月科亚与雷迪博士实验室的许可交易，如果所有里程碑都得到满足，这笔交易的价值可能高达7亿美元。他带来了丰富的战略、业务发展、运营和交易经验，有助于指导科亚公司下一阶段的企业发展。。

Dr. Swaminathan commented, “I would like to again thank our board of directors and Executive Chairman Howard Berman for the opportunity to lead Coya. Our pipeline targets severe neurodegenerative diseases facing millions of people across the globe, such as Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease, Frontotemporal Dementia, and Parkinson’s disease.

斯瓦米纳坦博士评论道：“我要再次感谢我们的董事会和执行主席霍华德·伯曼（Howard Berman）有机会领导Coya。我们的管道针对全球数百万人面临的严重神经退行性疾病，如肌萎缩侧索硬化症（ALS），阿尔茨海默氏病，额颞叶痴呆和帕金森氏病。

We believe our combination therapeutic approach targeting neuroinflammation can unlock a new paradigm in neurodegenerative treatment..

我们相信我们针对神经炎症的联合治疗方法可以开启神经退行性治疗的新范例。。

“We are encouraged by data from the Phase 2 investigator-initiated trial in patients with mild to moderate Alzheimer’s disease treated with low-dose interleukin-2 (LD IL-2), shared at CTAD, validating of our Treg platform. The study demonstrated stabilization of cognition with statistically significant CSF biomarker improvement in the lower dose IL-2 arm, confirming the known biology of the relationship between IL-2 dose and Treg enhancement.

“我们对CTAD共享的低剂量白细胞介素-2（LD IL-2）治疗的轻度至中度阿尔茨海默病患者的第二阶段研究者启动的试验数据感到鼓舞，验证了我们的Treg平台。该研究表明，低剂量IL-2组的认知稳定，CSF生物标志物改善具有统计学意义，证实了IL-2剂量与Treg增强之间关系的已知生物学。

Previous studies have shown that lower IL-2 doses selectively enhance and increase Treg function, while higher IL-2 doses reduce Treg function via several relevant mechanisms. This dynamic was observed in this study and helped us identify the lower dose of LD IL-2 as the right dose that enhances durable Tregs in patients with Alzheimer’s disease.

先前的研究表明，较低的IL-2剂量选择性地增强和增加Treg功能，而较高的IL-2剂量通过几种相关机制降低Treg功能。在这项研究中观察到了这种动态，并帮助我们确定较低剂量的LD IL-2是增强阿尔茨海默病患者持久性Tregs的正确剂量。

The data now opens the potential for a multitude of strategic opportunities involving biologic combinations that we intend to vigorously pursue,” concluded Dr. Swaminathan..

斯瓦米纳坦博士总结道：“这些数据现在为我们打算大力追求的涉及生物组合的众多战略机会开辟了潜力。”。。

About Alzheimer’s Disease

关于阿尔茨海默病

Alzheimer's disease is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer's disease accounts for up to 80% of dementia cases, affecting an estimated 5.7 million Americans. In more than 90% of people with Alzheimer’s, symptoms do not appear until after age 60.

阿尔茨海默病是痴呆症最常见的原因，痴呆症是记忆丧失和其他严重干扰日常生活的认知能力的统称。阿尔茨海默氏病占痴呆症病例的80%，估计影响了570万美国人。在90%以上的阿尔茨海默病患者中，症状直到60岁以后才出现。

The incidence of the disease increases with age and doubles every 5 years beyond age 65. Alzheimer's is a progressive disease, where dementia symptoms gradually worsen over a number of years. In its early stages, memory loss is mild, but with late-stage Alzheimer's, individuals lose the ability to carry on a conversation and respond to their environment.

该病的发病率随着年龄的增长而增加，65岁以后每5年增加一倍。。在早期阶段，记忆丧失是轻微的，但随着晚期阿尔茨海默病的发展，个体失去了进行对话和对环境做出反应的能力。

It is the sixth leading cause of death among all adults and the fifth leading cause for those aged 65 or older. On average, a person with Alzheimer's lives 4 to 8 years after diagnosis but can live as long as 20 years, depending on other factors. 1,2.

它是所有成年人中第六大死因，也是65岁或以上人群的第五大死因。阿尔茨海默病患者平均寿命为诊断后4至8年，但根据其他因素，其寿命可长达20年。1,2。

Alzheimer’s Association (www.alz.org)

阿尔茨海默氏症协会（www.alz.org）

Centers for Disease Control and Prevention (www.cdc.gov)

疾病控制和预防中心（www.cdc.gov）

About COYA 301

关于COYA 301

COYA 301 is the company’s proprietary investigational low-dose interleukin-2 (IL-2) intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and is designed for subcutaneous administration. COYA 301 is an investigational product not yet approved by the FDA or any other regulatory agency..

。COYA 301是一种尚未获得FDA或任何其他监管机构批准的研究产品。。

About COYA 302

关于COYA 302

COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin fusion protein (CTLA4-Ig) and is being developed for subcutaneous administration for the treatment of patients with ALS, FTD, and Parkinson’s Diseases (PD).

COYA 302是一种研究性和专有的生物联合疗法，具有双重免疫调节作用机制，旨在增强调节性T细胞（Tregs）的抗炎功能并抑制活化的单核细胞和巨噬细胞产生的炎症。COYA 302由专有的低剂量白细胞介素-2（LD IL-2）和细胞毒性T淋巴细胞相关抗原4免疫球蛋白融合蛋白（CTLA4-Ig）组成，正在开发用于皮下给药，用于治疗ALS，FTD和帕金森病（PD）患者。

These mechanisms may have additive or synergistic effects..

这些机制可能具有累加或协同效应。。

In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA4-Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D.

。

This study was the first-of-its-kind to evaluate this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) scale..

这项研究是首次评估这种用于治疗ALS的双重机制免疫疗法。该研究中的患者连续48周接受研究性治疗，并通过修订的肌萎缩侧索硬化功能评定量表（ALSFRS-R）量表评估其安全性和耐受性，Treg功能，氧化应激和炎症的血清生物标志物以及临床功能。。

During the 48-week treatment period, the therapy was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported.

在48周的治疗期间，治疗耐受性良好。最常见的不良事件是轻微的注射部位反应。没有患者停止研究，也没有死亡或其他严重不良事件的报告。

Patients' disease progression was measured using the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), suggesting significant amelioration in the progression of the disease over the 48-week treatment period..

使用ALSFRS-R量表测量患者的疾病进展，ALSFRS-R量表是一种经过验证的评估工具，用于监测ALS患者的残疾进展。治疗开始后第24周（33.75±3.3）和第48周（32±7.8）的平均（±SD）ALSFRS-R评分与基线时的ALSFRS-R评分（33.5±5.9）相比无统计学差异，表明48周治疗期间疾病进展显着改善。。

Treg suppressive function, expressed as a percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9 ±9.6) and 48 weeks (89.5 ±4.1) were significantly higher compared to baseline (62.1 ±8.1) (p<0.01), suggesting enhanced and durable Treg suppressive function over the course of treatment.

Treg抑制功能以抑制促炎性T细胞增殖的百分比表示，在治疗期间显示出统计学上显着的增加，并且在治疗后8周的清除期结束时显着降低。。

In contrast, Treg suppressive function (mean ±SD) was significantly decreased at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3 ±8.1 vs. 89.5 ±4.1, p <0.05)..

相比之下，与第48周治疗结束时相比，8周清除期结束时Treg抑制功能（平均值±SD）显着降低（70.3±8.1比89.5±4.1，p＜0.05）。。

The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease in these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing..

该研究还评估了炎症，氧化应激和脂质过氧化物的血清生物标志物。治疗开始后16周的可用数据表明这些生物标志物水平降低，这与观察到的Treg功能增强一致。正在对完整的生物标志物数据进行评估。。

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

COYA 302是一种尚未获得FDA或任何其他监管机构批准的研究产品。

About Coya Therapeutics, Inc.

关于Coya Therapeutics，Inc。

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in a lack of homeostasis of the immune system..

Coya Therapeutics，Inc.（纳斯达克股票代码：Coya）总部位于德克萨斯州休斯顿，是一家临床阶段生物技术公司，开发专有治疗方法，专注于调节性T细胞（“Tregs”）的生物学和潜在治疗优势，以靶向全身炎症和神经炎症。。。

Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

Coya的研究产品候选管道利用多种治疗方式，旨在恢复Tregs的抗炎和免疫调节功能。Coya的治疗平台包括Treg增强生物制剂，Treg衍生的外泌体和自体Treg细胞疗法。

COYA 302 – the Company’s lead biologic investigational product or “Pipeline in a Product”– is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease.

COYA 302是该公司领先的生物研究产品或“产品中的管道”，是COYA 301（COYA专有的LD IL-2）和CTLA4 Ig的专有组合，用于皮下给药，具有独特的双重作用机制，目前正在开发用于治疗肌萎缩侧索硬化症，额颞痴呆，帕金森病和阿尔茨海默病。

Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone..

其多靶点方法增强了Tregs的数量和抗炎功能，同时降低了活化小胶质细胞的表达和促炎介质的分泌。这种协同机制可能导致以持续和持久的方式重建免疫平衡和改善炎症，这可能是单独使用低剂量IL-2或CTLA4 Ig所无法实现的。。

For more information about Coya, please visit www.coyatherapeutics.com

有关Coya的更多信息，请访问www.coyatherapeutics.com

Forward-Looking Statements

前瞻性声明

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities.

本新闻稿包含基于管理层的信念和假设以及管理层目前可获得的信息的“前瞻性”声明。。

The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements..

“相信”、“可能”、“会”、“估计”、“继续”、“预期”、“打算”、“预期”等词语以及类似的表达旨在识别前瞻性陈述。。

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital .

前瞻性陈述受到已知和未知风险、不确定性、假设和其他因素的影响，包括但不限于与新型冠状病毒影响相关的风险；我们的产品候选开发活动以及正在进行和计划进行的临床试验的成功，成本和时间安排；我们计划开发和商业化靶向治疗药物；我们的临床前或临床试验中患者登记和给药的进展；我们的候选产品在临床试验中达到适用终点的能力；我们候选产品的安全概况；我们的临床试验数据支持营销应用的潜力，以及这些事件的时间安排；我们获得运营资金的能力；我们候选产品的开发和商业化；获得和维持监管批准的时间和能力；我们候选产品的市场接受率和程度以及临床实用性；我们候选产品的市场规模和增长潜力，以及我们服务这些市场的能力；我们的商业化、营销和制造能力和战略；；我们对获得和维持知识产权保护能力的期望；我们对第三方制造商的依赖；已经或可能获得的竞争疗法或产品的成功；我们吸引和留住关键科学或管理人员的能力；我们能够确定与我们的商业目标一致的具有重大商业潜力的其他候选产品；以及我们对费用、未来收入和资本的估计。

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs.

我们的这些前瞻性陈述主要基于我们目前对未来事件和趋势的预期和预测，我们认为这些事件和趋势可能会影响我们的财务状况、运营结果、业务战略、短期和长期业务运营和目标以及财务需求。

Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make.

此外，我们的经营环境竞争激烈，变化迅速，新的风险可能会不时出现。我们的管理层不可能预测所有风险，也不可能评估所有因素对我们业务的影响，也不可能评估任何因素或因素组合可能导致实际结果与我们可能做出的任何前瞻性陈述中所包含的结果存在重大差异的程度。

In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur.

鉴于这些风险、不确定性和假设，本文讨论的前瞻性事件和情况可能不会发生，实际结果可能与前瞻性声明中预期或暗示的结果存在重大不利差异。虽然我们的管理层认为我们的前瞻性声明中反映的期望是合理的，但我们不能保证前瞻性声明中描述的未来结果、活动水平、绩效或事件和情况能够实现或发生。

We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise..

我们没有义务公开更新任何前瞻性声明，无论是书面的还是口头的，无论是由于新信息、未来发展还是其他原因。。