KT-621 (STAT6) Phase 1 healthy volunteer trial ongoing, with data expected in 2Q25

KT-621（STAT6）第一阶段健康志愿者试验正在进行中，预计第二季度将有数据

Kymera plans to initiate a KT-621 Phase 1b trial in atopic dermatitis (AD) patients in 2Q25 with data in 4Q25 and plans to initiate parallel Phase 2b trials in AD and asthma in late 2025 and early 2026, respectively

Kymera计划在第二季度对特应性皮炎（AD）患者进行KT-621 1b期试验，第四季度有数据，并计划分别在2025年末和2026年初对AD和哮喘进行平行的2b期试验

KT-295 (TYK2) to advance into Phase 1 testing in 2Q25 with data expected in late 2025

KT-295（TYK2）将于2015年第二季度进入第一阶段测试，预计数据将于2025年末发布

KT-474/SAR444656 (IRAK4) Phase 2b dose-ranging studies in hidradenitis suppurativa (HS) and AD ongoing, with completion expected in 1H26 and mid-2026, respectively

KT-474/SAR444656（IRAK4）在化脓性汗腺炎（HS）和AD中的2b期剂量范围研究正在进行中，预计分别于2016年下半年和2026年年中完成

Novel oral immunology program with a first-in-class development candidate to be disclosed in 1H25

新的口腔免疫学计划，一流的发展候选人将在1H25中公开

Well-capitalized with $850

资本充足，850美元

1

1

million in cash and runway into mid-2027

百万现金和跑道到2027年年中

Kymera to present its 2025 outlook at J.P. Morgan Annual Healthcare Conference on

Kymera将在摩根大通（J.P.Morgan）年会上发布2025年展望

Tuesday, January 14, 2025, at 9:00 a.m. PT/12:00 p.m. ET

2025年1月14日星期二，美国东部时间上午9:00/下午12:00

WATERTOWN, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) --

马萨诸塞州沃特敦，2025年1月14日（环球通讯社）--

Kymera Therapeutics, Inc.

凯美拉治疗公司。

(NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines with biologics-like activity for immunological diseases, today announced its corporate goals for 2025, including anticipated progress on its clinical pipeline of immunology programs..

（纳斯达克：KYMR）是一家临床阶段的生物制药公司，致力于开发一类新型口服小分子降解药物，具有类似生物制剂的免疫疾病活性，今天宣布了2025年的公司目标，包括免疫学项目临床管道的预期进展。。

“We expect 2025 to be another year of significant progress and accomplishments, and likely our busiest year to date. After unveiling our broader immunology strategy and new pipeline last year, we are poised to demonstrate the clinical potential of our first-in-class, wholly owned STAT6 and TYK2 oral degrader programs,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics.

Kymera Therapeutics创始人、总裁兼首席执行官内洛·梅诺尔菲（Nello Mainolfi）博士表示：“我们预计2025年将是又一个取得重大进展和成就的年份，也是迄今为止最繁忙的一年。在去年公布了更广泛的免疫学策略和新管道之后，我们准备展示我们一流的全资拥有的STAT6和TYK2口腔降解剂项目的临床潜力。”。

“Our vision is to leverage the power of targeted protein degradation to deliver, for the first time in industry, oral drugs with biologics-like activity that have the potential to revolutionize the treatment of many inflammatory diseases with significant unmet needs. We are rapidly progressing the development of our first-in-industry oral STAT6 degrader, KT-621, and will have Phase 1 healthy volunteer data, Phase 1b atopic dermatitis data, as well as initiate the first Phase 2b study, all in 2025.”.

“我们的愿景是利用靶向蛋白质降解的力量，首次在工业上提供具有类似生物制剂活性的口服药物，这些药物有可能彻底改变许多炎症性疾病的治疗方法，这些疾病的需求尚未得到满足。我们正在迅速开发我们的第一种工业口服STAT6降解剂KT-621，并将在2025年获得第一阶段健康志愿者数据，1b期特应性皮炎数据，以及启动第一阶段2b研究。”。

Dr. Mainolfi continued, “In addition to the significant progress we expect with our disclosed immunology programs, we look forward to expanding our immunology pipeline with a new program disclosure in the first half of 2025, continuing to build what we believe is the best oral immunology portfolio in industry.”.

Mainolfi博士继续说道，“除了我们所披露的免疫学计划取得的重大进展外，我们还期待着在2025年上半年通过新的计划披露扩大我们的免疫学渠道，继续建立我们认为是业界最好的口腔免疫组合。”。

Additional details around Kymera's pipeline, including its development plans for KT-621, will be presented today at the J.P. Morgan Healthcare Conference.

关于Kymera管道的更多细节，包括其KT-621的开发计划，将于今天在摩根大通医疗保健会议上介绍。

Program updates on the company's disclosed programs and platform include:

公司披露的计划和平台的计划更新包括：

STAT6 Degrader Program

STAT6降解程序

KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Th2 inflammation. Currently in Phase 1 testing, KT-621 has demonstrated dupilumab-like activity and very good safety data in preclinical models.

KT-621是STAT6的研究性一流口服降解剂，STAT6是负责IL-4/IL-13信号传导的特异性转录因子，也是Th2炎症的主要驱动因素。目前在第一阶段测试中，KT-621在临床前模型中显示出dupilumab样活性和非常好的安全性数据。

Recruiting for the KT-621 Phase 1 heathy volunteer trial is ongoing, with multiple single ascending dose (SAD) and multiple ascending dose (MAD) cohorts completed. KT-621 has the potential to address numerous Th2 diseases including AD, asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU) and prurigo nodularis (PN), among others.

正在招募KT-621第一阶段健康志愿者试验，完成了多个单次递增剂量（SAD）和多个递增剂量（MAD）队列。KT-621有可能解决许多Th2疾病，包括AD，哮喘，慢性阻塞性肺病（COPD），慢性鼻-鼻窦炎伴鼻息肉（CRSwNP），嗜酸性粒细胞性食管炎（EoE），慢性自发性荨麻疹（CSU）和结节性痒疹（PN）等。

Kymera intends to develop KT-621, an oral drug with potential for biologics-like efficacy, with the goal of transforming the treatment paradigm for the more than 130 million patients (children and adults) in the world suffering from Th2 diseases..

Kymera打算开发KT-621，这是一种具有类似生物制剂功效潜力的口服药物，目标是为世界上1.3亿多患有Th2疾病的患者（儿童和成人）改变治疗模式。。

Key upcoming KT-621 milestones

:

:

Complete KT-621 Phase 1 healthy volunteer clinical trial and report data in the second quarter of 2025.

2025年第二季度完成KT-621第一阶段健康志愿者临床试验并报告数据。

Advance KT-621 into a Phase 1b clinical trial in AD patients in the second quarter of 2025 and report data in the fourth quarter of 2025.

在2025年第二季度将KT-621推进AD患者的1b期临床试验，并在2025年第四季度报告数据。

Initiate KT-621 Phase 2b clinical trial in AD in the fourth quarter of 2025, followed by a Phase 2b clinical trial in asthma in early 2026.

2025年第四季度在AD启动KT-621 2b期临床试验，然后在2026年初进行哮喘2b期临床试验。

TYK2 Degrader Program

TYK2 降级 程序

KT-295 is an investigational, first-in-class, once daily, oral degrader of TYK2, a member of the Janus kinase (JAK) family required for Type I IFN, IL-12 and IL-23 signaling. Given KT-295’s ability, observed in preclinical studies, to replicate the human genetic loss of function profile of TYK2, and to block the pathway to the level of upstream biologics (e.g., anti-IL-23), KT-295 has the potential to be the first oral therapy to deliver biologics-like activity in diseases such as IBD, psoriasis and others..

KT-295是TYK2的研究性一流口服降解剂，TYK2是I型IFN，IL-12和IL-23信号传导所需的Janus激酶（JAK）家族的成员。鉴于在临床前研究中观察到的KT-295能够复制TYK2的人类遗传功能丧失特征，并阻断上游生物制剂（例如抗IL-23）水平的途径，KT-295有可能成为第一种在IBD，牛皮癣等疾病中提供生物制剂样活性的口服疗法。。

Key upcoming KT-295 milestones

即将到来的关键KT-295里程碑

:

:

File KT-295 IND and initiate dosing in the Phase 1 healthy volunteer clinical trial in the second quarter of 2025, with Phase 1 data expected in the fourth quarter of 2025.

提交KT-295 IND，并于2025年第二季度在第一阶段健康志愿者临床试验中开始给药，预计2025年第四季度将有第一阶段数据。

IRAK4 Degrader Program

IRAK4降级器项目

KT-474 (SAR444656) is an investigational, first-in-class, once daily, oral degrader of IRAK4, a key protein involved in TLR/IL-1R-driven inflammation. Given IRAK4’s ability to block IL-1 family cytokine and TLR signaling, KT-474 holds promise to be superior to individual upstream cytokines blockers (e.g., anti-IL-1, anti-IL-33) as an oral drug.

KT-474（SAR444656）是IRAK4的研究性一流口服降解剂，IRAK4是参与TLR/IL-1R驱动的炎症的关键蛋白。鉴于IRAK4阻断IL-1家族细胞因子和TLR信号传导的能力，KT-474有望作为口服药物优于单个上游细胞因子阻滞剂（例如抗IL-1，抗IL-33）。

Initial Phase 2b clinical trials for HS and AD, in collaboration with Sanofi, are currently ongoing with potential in the future to expand beyond these two indications..

HS和AD的初始2b期临床试验目前正在与赛诺菲合作进行，未来有可能扩展到这两个适应症之外。。

Key upcoming KT-474 milestones

即将到来的关键KT-474里程碑

:

:

Collaborate with Sanofi to advance the KT-474/SAR444656 (IRAK4) Phase 2b dose-ranging clinical trials in HS and AD, with primary completion expected in the first half of 2026 for HS and mid-2026 for AD.

与赛诺菲合作，推进HS和AD的KT-474/SAR444656（IRAK4）2b期剂量范围临床试验，预计HS将于2026年上半年初步完成，AD将于2026年中期初步完成。

Research Platform

研究平台

Leveraging its proven small molecule discovery capabilities, deep expertise, and unique target selection strategy, Kymera is building an industry leading portfolio of innovative oral immunology medicines addressing high value undrugged or poorly-drugged targets for areas of significant need.

利用其经验证的小分子发现能力，深厚的专业知识和独特的靶标选择策略，Kymera正在建立一个行业领先的创新口服免疫药物组合，以解决重要需求领域的高价值未强化或药物不良靶标。

Key upcoming pipeline disclosures

即将进行的关键管道披露

:

:

Kymera plans to announce the next immunology program, a first-in-class development candidate addressing an undrugged transcription factor, in the first half of 2025, and initiate clinical testing in early 2026.

Kymera计划在2025年上半年宣布下一个免疫学项目，这是一个一流的解决不稳定转录因子的开发候选人，并在2026年初启动临床测试。

For more information on Kymera’s pipeline visit our

有关Kymera管道的更多信息，请访问

website

网站

.

.

J.P. Morgan Healthcare Conference Webcast

J、 摩根大通医疗保健会议网络广播

Kymera will present its 2025 outlook at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, at 9:00 a.m. PT (12:00 p.m. ET). A live webcast of the presentation and Q&A session will be available under “

Kymera将于1月14日星期二上午9:00（美国东部时间下午12:00）在第43届摩根大通医疗保健年会上发布2025年展望。演示文稿和问答环节的在线直播将在“

News and Events

新闻和事件

” in the Investors section of the Company’s website at

“在公司网站的投资者部分

www.kymeratx.com

网站地址：www.kymeratx.com

. A replay of the webcast and the presentation will be archived on Kymera’s website following the event.

活动结束后，网络广播和演示文稿的重播将存档在Kymera的网站上。

1

1

Unaudited, estimated cash as of December 31, 2024.

截至2024年12月31日未经审计的估计现金。

About Kymera Therapeutics

关于Kymera Therapeutics

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics.

Kymera是一家临床阶段生物技术公司，开创了靶向蛋白质降解（TPD）领域，旨在开发解决关键健康问题的药物，并有可能显着改善患者的生活。Kymera正在部署TPD来解决常规疗法无法达到的疾病目标和途径。

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years.

。凯梅拉成立于2016年，过去几年来一直被公认为波士顿最佳工作场所之一。

For more information about our science, pipeline and people, please visit .

。

www.kymeratx.com

网站地址：www.kymeratx.com

or follow us on

或者继续关注我们

X

十

or

或

LinkedIn

LinkedIn

.

.

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on the clinical development of clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, Sanofi’s expansion of the Phase 2 clinical trials of KT-474/SAR444656, the Phase 1 data readout of KT-621 in the first half of 2025, the advancement of KT-295 into Phase 1 clinical testing, the declaration of its next clinical candidate and filing of an IND in second half of 2025, and Kymera’s financial condition and expected cash runway into mid-2027.

本新闻稿包含1995年《私人证券诉讼改革法案》修订版所指的前瞻性陈述，包括但不限于关于我们对临床和临床前管道临床开发的战略、商业计划和目标的预期的暗示和明示陈述，包括其治疗潜力、临床益处和安全性、赛诺菲扩大KT-474/SAR444656的第二阶段临床试验、2025年上半年KT-621的第一阶段数据读数、KT-295进入第一阶段临床试验、宣布其下一个临床候选人并在2025年下半年提交IND以及Kymera的财务状况和预期现金跑道到2027年年中。

The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target,' “upcoming” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“可能”、“可能”、“将”、“可能”、“将”、“应该”、“期望”、“计划”、“预期”、“打算”、“相信”、“期望”、“估计”、“寻求”、“预测”、“未来”、“项目”、“潜力”、“继续”、“目标”、“即将到来”等词或短语旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results of early clinical trials will be indicative of .

本新闻稿中的任何前瞻性陈述均基于管理层当前的期望和信念，并受到许多风险、不确定性和重要因素的影响，这些风险、不确定性和重要因素可能导致实际事件或结果与本新闻稿中的任何前瞻性陈述产生重大差异，包括但不限于与以下相关的风险：未来临床试验的启动、时间安排和设计固有的不确定性，正在进行和未来临床试验的数据的可用性和时间安排以及此类试验的结果，早期临床试验的初步结果是否具有指示意义。

Investor and Media Contact:

投资者和媒体联系人：

Justine Koenigsberg

贾斯汀 科尼斯伯格

Vice President, Investor Relations

investors@kymeratx.com

investors@kymeratx.com

media@kymeratx.com

media@kymeratx.com

857-285-5300

857-285-5300