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 Treg function, releases the following letter to stockholders from Chief Executive Officer Dr. Arun Swaminathan.

（纳斯达克：COYA）（“COYA”或“公司”）是一家开发旨在增强Treg功能的生物制剂的临床阶段生物技术公司，向股东发布首席执行官Arun Swaminathan博士的以下信函。

Dear Fellow Stockholder,

尊敬的股东朋友：，

Given my recent transition to the role of CEO, I wanted to share my thoughts on Coya and our future and to express my gratitude to our founder and Executive Chair, Dr. Howard Berman, whose bold vision has instilled the “innovation and get-it-done” culture in Coya’s DNA. We have made tremendous strides in 2024, repeatedly executing on our promises.

考虑到我最近过渡到首席执行官的角色，我想分享我对科亚和我们未来的想法，并向我们的创始人兼执行主席霍华德·伯曼博士表示感谢，他的大胆愿景将“创新并完成”文化灌输到科亚的DNA中。2024年，我们取得了巨大进步，反复履行我们的承诺。

As I look to 2025, I am confident that our nimble and highly experienced team will continue to exceed expectations..

展望2025年，我相信我们灵活且经验丰富的团队将继续超越预期。。

I have spent my entire 25-year career in the biotech space, and I believe that Coya has the most promise of any company that I have represented. I truly believe our novel science, strong clinical proof of concept data, pharmaceutical partnership validation, cash runway, and clear path to a commercial drug differentiates us.

我在生物技术领域度过了25年的职业生涯，我相信Coya在我所代表的任何公司中都是最有前途的。我真的相信，我们的新颖科学，强大的临床概念验证数据，药物合作伙伴验证，现金跑道以及通往商业药物的清晰道路使我们与众不同。

Prior to serving at Coya, I helped spearhead and lead pharmaceutical transactions worth billions of dollars that led to significant value creation. I believe the opportunities ahead of us in 2025 and beyond are what investors, stockholders, and patients should be most excited about. Our science and approach of regulating Tregs is now validated in multiple trials across multiple neurodegenerative diseases, we have a track record of executing value-creating non-dilutive deals, and our strong cash position allows us to be prudent in our decisions..

在Coya任职之前，我帮助领导了价值数十亿美元的医药交易，从而创造了巨大的价值。我相信2025年及以后我们面临的机遇是投资者、股东和患者最应该感到兴奋的。我们调节Tregs的科学和方法现已在多种神经退行性疾病的多项试验中得到验证，我们有执行创造价值的非稀释性交易的记录，我们强大的现金状况使我们能够谨慎决策。。

Year Ahead

未来一年

We expect our activities in 2025 to be focused on the following indications:

我们预计2025年的活动将集中在以下方面：

ALS (Amyotrophic Lateral Sclerosis) Program:

ALS（肌萎缩侧索硬化症）计划：

We have alignment with the FDA on the data required to initiate our potentially pivotal COYA 302 Phase 2 double-blind randomized study in patients with ALS. We are targeting the submission of the requested data package by 2Q 2025 and initiation of the clinical trial upon FDA clearance.

我们与FDA就启动我们对ALS患者的潜在关键COYA 302 2期双盲随机研究所需的数据进行了一致。我们的目标是在2025年第二季度提交所需的数据包，并在FDA批准后开始临床试验。

The roadmap to topline results is now clear with reduced uncertainty. In late 2023, we partnered with Dr. Reddy’s Laboratories, a multi-billion-dollar drug developer, to license COYA 302 in ALS in a deal that is worth up to $700 million. We still retain the rights to COYA 302 in ALS in Japan and South/Central America and Mexico, thus providing us direct upside and optionality in this indication alone..

最终结果的路线图现已清晰，不确定性降低。2023年末，我们与雷迪博士实验室（Dr.Reddy's Laboratories）合作，这是一家价值数十亿美元的药物开发公司，以高达7亿美元的交易授权COYA 302治疗ALS。我们仍然保留在日本、南/中美洲和墨西哥的ALS中使用COYA 302的权利，因此仅在这种情况下就为我们提供了直接的优势和可选性。。

FTD (Frontotemporal Dementia) Program:

FTD（额颞叶痴呆）计划：

We expect to see topline results in 2H 2025 from the investigator-initiated, open-label study of Low Dose IL-2 (LD IL-2) + CTLA4-Ig in FTD. Study endpoints will measure safety, peripheral and central inflammation, FTD progression, and pharmacodynamic effects on Treg cell populations.

我们预计在2025年下半年将看到研究者发起的FTD中低剂量IL-2（LD IL-2）+CTLA4 Ig的开放标签研究的结果。研究终点将测量安全性，外周和中枢炎症，FTD进展以及对Treg细胞群的药效学影响。

The data are expected to guide our planned COYA 302 Phase 2 double-blind randomized study (which will be funded by the Alzheimer’s Drug Discovery Foundation) and further optimize the design for success. The guidance from the FDA on the ALS IND reduces uncertainty on the planned IND filing for FTD in 2H of 2025.

这些数据有望指导我们计划的COYA 302 2期双盲随机研究（将由阿尔茨海默病药物发现基金会资助），并进一步优化设计以取得成功。FDA关于ALS IND的指导减少了2025年下半年计划的FTD IND申请的不确定性。

We have retained full commercial rights on this program thus far, providing us optionality to develop the program to BLA approval ourselves and capture the full potential upside or partner at a later stage once we obtain additional clinical data..

到目前为止，我们保留了该计划的全部商业权利，为我们提供了自行开发该计划以获得BLA批准的选择权，并在获得其他临床数据后的后期阶段获得了全部潜在优势或合作伙伴。。

AD (Alzheimer’s disease) Program:

AD（阿尔茨海默病）计划：

Complementing the promising data that was presented at CTAD in Madrid for LD IL-2 in mild to moderate AD, the investigators will disclose additional data in 1H 2025 that summarizes the changes in inflammation in the peripheral system (blood) and central nervous system (CSF and brain) and other molecular measurements for the two IL-2 dosing arms vs.

作为对马德里CTAD上针对轻度至中度AD患者LD IL-2提供的有希望的数据的补充，研究人员将在2025年上半年披露更多数据，总结外周系统（血液）和中枢神经系统（脑脊液和大脑）炎症的变化，以及两个IL-2给药组与其他分子测量。

placebo. These important data will help to further address the basic science associated with the promising clinical response observed in the lower dose IL-2 arm and its association with better Treg enhancement. We retain full rights to the AD indication for COYA 302 and are already in the process of exploring non-dilutive and strategic partnering opportunities.

安慰剂。这些重要数据将有助于进一步解决与低剂量IL-2组中观察到的有希望的临床反应相关的基础科学及其与更好的Treg增强的关联。我们保留COYA 302广告的全部权利，并且已经在探索非稀释性和战略性合作机会。

While the CTAD data was based on LD IL-2 alone and proved highly promising in and of itself, COYA 302, which is a proprietary combination of LD IL-2 and CTLA4-Ig, targets multiple pathways and is developed to more significantly and durably enhance Treg function, which we believe will be highly attractive to potential partners..

虽然CTAD数据仅基于LD IL-2，并且本身被证明是非常有前途的，但COYA 302是LD IL-2和CTLA4 Ig的专有组合，靶向多种途径，并且被开发用于更显着和持久地增强Treg功能，我们相信这对潜在的合作伙伴将具有很高的吸引力。。

Strategic Partnerships

战略伙伴关系

Dr. Reddy’s Partnership:

Reddy博士的合作伙伴关系：

Our partnership with Dr. Reddy’s Laboratories is approaching its one-year anniversary, and our collaboration could not be stronger. We have a reliable partner for ALS, and leveraging its resources and expertise has created value beyond the milestone payments.

我们与Reddy博士实验室的合作关系即将迎来一周年纪念日，我们的合作再强不过了。。

In 2025, we anticipate receiving $8.4 million upon initiation of the Phase 2 ALS clinical trial and will continue to evaluate opportunities to further deepen the relationship..

2025年，我们预计在第二阶段ALS临床试验开始时将收到840万美元，并将继续评估进一步加深关系的机会。。

Other Strategic Possibilities:

其他战略可能性：

As I have described, my background is one of deal-making, and I intend to leverage my network and capabilities to maximize opportunities for Coya in 2025. We have only partnered COYA 302 in ALS, and the optionality to partner, co-develop, or license the asset in other indications exists.

正如我所描述的，我的背景是交易，我打算利用我的网络和能力，在2025年为科亚创造最大的机会。我们仅在ALS中与COYA 302合作，并且存在在其他适应症中合作，共同开发或许可资产的选择权。

Any potential transaction will be evaluated based on maximizing stockholder value. The positive data from the investigator-initiated trial of LD IL-2 in patients with Alzheimer’s disease increases our confidence in obtaining value-creating pharma partnerships that combine our proprietary LD IL-2, COYA 301, with other modalities.

任何潜在交易都将以股东价值最大化为基础进行评估。来自研究者发起的阿尔茨海默病患者LD IL-2试验的积极数据增加了我们获得创造价值的制药合作伙伴关系的信心，该合作伙伴关系将我们专有的LD IL-2 COYA 301与其他方式相结合。

I can envision multiple opportunities with LD IL-2 serving as a backbone adjuvant with standard of care agents and other novel pathways..

我可以设想LD IL-2作为具有标准护理剂和其他新途径的骨干佐剂的多种机会。。

Moreover, the opportunity for grant funding and financial support from foundations exists and will be vigorously pursued. We believe the data emerging on Tregs in autoimmune disease (such as lupus, rheumatoid arthritis, and scleroderma) and, in particular, treatment with LD IL-2 is compelling and may strengthen the role of COYA 302 and LD IL-2 combinations in this space.

此外，基金会提供赠款和财政支持的机会已经存在，并将大力寻求。我们认为Tregs在自身免疫性疾病（如狼疮，类风湿性关节炎和硬皮病）中出现的数据，特别是用LD IL-2治疗的数据是令人信服的，可能会加强COYA 302和LD IL-2组合在这一领域的作用。

I intend to actively pursue partnerships in this arena that would further place us in a strong position to pursue value-creating deals..

我打算在这个领域积极寻求合作伙伴关系，这将进一步使我们处于寻求创造价值交易的有利地位。。

Value-Creating Pipeline

创造价值的管道

Like many experts in the scientific community, we believe combination strategies are the future to address devastating neurodegenerative diseases. We believe targeting one mechanism or pathway is likely insufficient to achieve maximal effect - hence our approach with COYA 302. COYA 302 is a “Pipeline within a Product” and has strong potential in ALS, FTD, AD, Parkinson’s disease, and other indications..

。我们认为针对一种机制或途径可能不足以实现最大效果-因此我们使用COYA 302的方法。COYA 302是一种“产品中的管道”，在ALS，FTD，AD，帕金森氏病和其他适应症方面具有很强的潜力。。

We are continuously building our intellectual property to further enhance the value of Coya. One recent development is the combination of COYA 301 and GLP-1 agonists. Data suggests that the mechanism of action appears additive and/or synergistic in ameliorating inflammation. This is yet another opportunity for value-creating strategic partnerships.

我们正在不断建设我们的知识产权，以进一步提高Coya的价值。最近的一个发展是COYA 301和GLP-1激动剂的组合。数据表明，作用机制在改善炎症方面似乎是累加和/或协同的。这是创造价值的战略伙伴关系的又一次机会。

We intend to publish more detailed data in 1Q 2025..

我们打算在2025年第一季度发布更详细的数据。。

Conclusion

结论

As you can see from our past performance, our entire management team is committed to the success of Coya. We expect to recognize a number of clinical, regulatory, and/or commercial milestones in 2025 that will help us advance the treatment of neurodegenerative diseases.

从我们过去的表现可以看出，我们的整个管理团队都致力于科雅的成功。我们希望在2025年认识到一些临床，监管和/或商业里程碑，这将有助于我们推进神经退行性疾病的治疗。

On behalf of the entire Coya team, please accept our sincere gratitude for both your support and belief in our science, our story, and our team. We look forward to presenting additional clinical data and updating you on our additional corporate developments as they unfold. Onwards and upwards!

请代表整个科雅团队接受我们诚挚的感谢，感谢您对我们的科学、故事和团队的支持和信念。我们期待着提供更多的临床数据，并向您介绍我们其他公司发展的最新情况。向前和向上！

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 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

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；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；；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，我们也无法评估所有因素对我们业务的影响，或者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 will 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、绩效或事件和情况会实现或发生。

We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether because 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，无论是因为新信息、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 Contact

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。