This open-label Phase 1 study measures safety, peripheral and central inflammation, effects on Treg cell populations, and FTD progression;

这项开放标签的1期研究测量了安全性，外周和中枢炎症，对Treg细胞群的影响以及FTD进展；

Five of the 8 planned FTD subjects have been enrolled to date;

迄今为止，计划的8个FTD科目中有5个已被录取；

Results of study will inform Coya’s randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD

研究结果将为Coya对FTD患者进行Coya 302的随机双盲2期试验提供信息

HOUSTON--(BUSINESS WIRE)--

休斯顿--（商业新闻）--

Coya Therapeutics, Inc.

科亚治疗公司。

(NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that five of eight patients have been enrolled in the investigator-initiated academic study of LD IL-2 + CTLA4-Ig combination in patients with Frontotemporal Dementia (FTD).

（纳斯达克：COYA）（“COYA”或“公司”）是一家开发旨在增强调节性T细胞（Treg）功能的生物制剂的临床阶段生物技术公司，宣布八名患者中有五名已参加由研究者发起的额颞叶痴呆（FTD）患者LD IL-2+CTLA4-Ig组合的学术研究。

The study is being conducted by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital. Topline results of the study will be leveraged to inform and finalize the planned trial design of a Company-sponsored, randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD. Coya has been awarded $5 million by the Alzheimer’s Drug Discovery Foundation (ADDF) to support the development of COYA 302 in FTD..

这项研究由休斯顿卫理公会医院的斯坦利·阿佩尔（StanleyAppel）博士和阿里扎·法里达尔（AlirezaFaridar）博士进行。该研究的主要结果将被用于通知和最终确定公司赞助的COYA 302在FTD患者中的随机双盲2期试验的计划试验设计。Coya已被阿尔茨海默病药物发现基金会（ADDF）授予500万美元，以支持FTD中Coya 302的开发。。

The current investigator-initiated study is evaluating the effects of LD IL-2 + CTLA4-Ig on a variety of parameters in patients with FTD, including safety, tolerability, Treg cell populations, peripheral and central inflammation, and disease progression. COYA 302 is a proprietary formulation of this biologic combination therapy, comprised of low dose interleukin-2 (LD IL-2) and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin fusion protein (CTLA4-Ig)..

目前由研究者发起的研究正在评估LD IL-2+CTLA4 Ig对FTD患者多种参数的影响，包括安全性，耐受性，Treg细胞群，外周和中枢炎症以及疾病进展。COYA 302是这种生物联合疗法的专有制剂，由低剂量白细胞介素-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。。

Fred Grossman D.O., President and CMO of Coya, stated, “

Coya总裁兼首席营销官弗雷德·格罗斯曼（FredGrossman）表示

We plan to submit an IND for FTD, and the data from the investigator-initiated study will inform some design features of this planned trial. COYA 302 has potential therapeutic application in a variety of neurodegenerative diseases, starting with ALS and FTD.”

我们计划为FTD提交IND，研究者发起的研究的数据将为该计划试验的一些设计特征提供信息。COYA 302在各种神经退行性疾病中具有潜在的治疗应用，从ALS和FTD开始。”

Tregs are dysfunctional and compromised in patients with FTD, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. The combination of LD IL-2 + CTLA4-Ig is believed to have additive and/or synergistic effects on enhancing Treg cell populations and lowering peripheral/central inflammation..

。据信LD IL-2+CTLA4 Ig的组合对增强Treg细胞群和降低外周/中枢炎症具有累加和/或协同作用。。

Prior data presented by the investigators at the AD/PD 2024 Conference in March 2024 demonstrated that Treg suppressive function was significantly reduced in patients with FTD, compared to controls (p<0.01), demonstrating that Treg immunomodulatory function is negatively impacted in FTD and peripheral levels of inflammatory cytokines and chemokines are increased, supporting the critical role of the immune system in the pathophysiology of FTD.

研究人员在2024年3月AD/PD 2024会议上提供的先前数据表明，与对照组相比，FTD患者的Treg抑制功能显着降低（p＜0.01），表明Treg免疫调节功能在FTD中受到负面影响，外周炎性细胞因子和趋化因子水平升高，支持免疫系统在FTD病理生理学中的关键作用。

Treg dysfunction and increased levels of inflammatory cytokines and chemokines have been previously reported by Coya in other serious and progressive neurodegenerative diseases and support the multi-pathway combination approach of COYA 302 to target numerous components of the dysfunctional immune system..

Coya先前已在其他严重和进行性神经退行性疾病中报道了Treg功能障碍以及炎性细胞因子和趋化因子水平升高，并支持Coya 302的多途径组合方法，以靶向功能失调的免疫系统的许多成分。。

About Frontotemporal Dementia

关于额颞叶痴呆

Frontotemporal dementia (FTD) is the result of damage to neurons in the frontal and temporal lobes of the brain. Many possible symptoms can result, including unusual behaviors, emotional problems, trouble communicating, difficulty with work, or difficulty with walking.

。可能导致许多可能的症状，包括异常行为、情绪问题、沟通困难、工作困难或行走困难。

FTD is rare and tends to occur at a younger age than other forms of dementia. About 60% of people with FTD are 45 to 64 years old. FTD is progressive, meaning symptoms get worse over time. In the early stages, people may have just one symptom. As the disease progresses, other symptoms appear as more parts of the brain are affected.

FTD很少见，并且比其他形式的痴呆症更容易发生在年轻的年龄。大约60%的FTD患者年龄在45至64岁之间。FTD是进行性的，这意味着症状会随着时间的推移而恶化。在早期阶段，人们可能只有一种症状。随着疾病的进展，随着大脑更多部位受到影响，还会出现其他症状。

It is difficult to predict how long someone with FTD will live. Some people live more than 10 years after diagnosis, while others live less than two years after they are diagnosed. There is no cure for FTD, and no treatments slow or stop the progression of the disease.1.

很难预测患有FTD的人会活多久。一些人在确诊后活了10年以上，而另一些人在确诊后活不到两年。FTD无法治愈，也没有任何治疗方法可以减缓或阻止疾病的进展。

References

参考文献

Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725.

Atassi N等人。PRO-ACT数据库：设计，初步分析和预测特征。神经病学，2014；83:1719年至1725年。

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 CTLA-4 Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas). This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS.

2023年2月，Coya宣布了在休斯顿卫理公会研究所（德克萨斯州休斯顿）进行的一小群ALS患者中评估市售LD IL-2和CTLA-4 Ig的概念验证开放标签临床研究结果。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。

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 ALSFRS-R scale..

该研究中的患者连续48周接受研究性治疗，并通过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 ALSFRS-R scores at week 24 and week 48 after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline, suggesting that disease progression was ameliorated 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周和第48周的平均ALSFRS-R评分与基线时的ALSFRS-R评分相比无统计学差异，表明在48周的治疗期间疾病进展得到改善。

Treg suppressive function, expressed as 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。。

The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggested 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。。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 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。功能失调的Tregs是许多疾病的基础，包括神经退行性疾病，代谢性疾病和自身免疫性疾病，这种细胞功能障碍可能导致持续的炎症和氧化应激，导致免疫系统缺乏稳态。。

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 therapy consisting 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–该公司领先的生物研究产品或“产品中的管道”是一种专有的联合疗法，由COYA 301（COYA专有的LD IL-2）和CTLA4 Ig组成，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性侧索硬化症，额颞叶痴呆，帕金森病和阿尔茨海默病。

Its multi-targeted approach is designed to enhance the number and anti-inflammatory function of Tregs and simultaneously lower 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..

。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

有关Coya的更多信息，请访问

www.coyatherapeutics.com.

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.

本新闻稿包含基于我们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。前瞻性陈述包括除本演示文稿中包含的历史事实陈述之外的所有陈述，包括有关我们当前和未来财务业绩、业务计划和目标、当前和未来临床和临床前开发活动、我们正在进行和计划中的临床试验和相关数据的时机和成功、我们临床试验和相关数据的发布时间、更新和结果、我们获得和维持监管批准的能力、我们候选产品的潜在治疗效益和经济价值、竞争地位、行业环境和潜在市场机会的信息。

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 re.

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；与第三方就我们候选产品的商业化达成的未来协议；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、资本重组的估计。

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。。

Investor Contact

投资者联系人

David Snyder, CFO

首席财务官David Snyder

david@coyatherapeutics.com

david@coyatherapeutics.com

CORE IR

核心IR

Bret Shapiro

布雷特·夏皮罗

brets@coreir.com

brets@coreir.com

561-479-8566

561-479-8566

Media Contacts

媒体联系人

For Coya Therapeutics:

对于Coya Therapeutics：

Kati Waldenburg

卡蒂·瓦尔登堡

media@coyatherapeutics.com

media@coyatherapeutics.com

212-655-0924

212-655-0924

Source: Coya Therapeutics, Inc.

资料来源：Coya Therapeutics，Inc。