Important progress across four clinical-stage programs demonstrating depth and breadth of obesity pipeline
Initiated five late-stage global clinical trials in obesity, including the ribupatide injection KaiNETIC Phase 3 program
Reported positive topline clinical data from three trials conducted by our partner Hengrui in China, including new topline data from Phase 3 trial of oral small molecule GLP-1 receptor agonist HRS-7535 (KAI-7535) in type 2 diabetes, and first-in-human topline data from Phase 1 trial for injectable tri-agonist HRS-4729 (KAI-4729)
Cash on hand, including IPO proceeds, is expected to fund operations into mid-2028

在四个临床阶段项目中取得重要进展，展示了肥胖药物研发的深度和广度
启动了五项晚期全球临床试验，涉及肥胖治疗，包括 ribupatide 注射剂 KaiNETIC 三期项目
报告了我们在中国的合作伙伴恒瑞医药进行的三项试验的积极顶线临床数据， 包括针对 2 型糖尿病的口服小分子 GLP-1 受体激动剂 HRS-7535 (KAI-7535) 的三期试验的新顶线数据，以及针对可注射三重激动剂 HRS-4729 (KAI-4729) 的首次人体三期试验的顶线数据
手头现金，包括首次公开募股的收益，预计将支持运营至 2028 年中期

WALTHAM, Mass., May 26, 2026 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (Nasdaq: KLRA) (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today reported financial results for the first quarter ended March 31, 2026, and provided a summary of recent business highlights.

马萨诸塞州沃尔瑟姆，2026年5月26日（全球新闻通讯社）-- Kailera Therapeutics, Inc.（纳斯达克：KLRA）（Kailera）是一家专注于提升肥胖护理下一个时代的临床阶段生物技术公司，今天报告了截至2026年3月31日的第一季度财务业绩，并提供了近期业务亮点的总结。

“During the quarter, we continued to build meaningful momentum and made significant progress advancing our clinical portfolio, including initiating several clinical trials and reporting important data readouts that further underscore the breadth, depth, and potential of our pipeline,” said Ron Renaud, President and Chief Executive Officer of Kailera. “Importantly, our ribupatide franchise continues to demonstrate category-leading potential among obesity management medications, highlighted by the initiation of the global KaiNETIC Phase 3 program for ribupatide injection and positive Phase 2 data for ribupatide oral in China. We are also pleased to announce new topline data for HRS-7535 (KAI-7535) and HRS-4729 (KAI-4729) that reflect the shared commitment with our partner to advance a diverse portfolio with multiple mechanisms and injectable and oral modalities to help address the diverse and evolving needs of people living with obesity.”

“在本季度，我们继续建立有意义的势头，并在推进我们的临床组合方面取得了重大进展，包括启动多个临床试验和报告重要的数据结果，进一步强调了我们管道的广度、深度和潜力，” Kailera 的总裁兼首席执行官 Ron Renaud 表示。“重要的是，我们的 ribupatide 系列继续在肥胖管理药物中展示出领先的潜力，特别是通过启动全球 KaiNETIC 三期项目和在中国获得的 ribupatide 口服剂的积极二期数据。我们也很高兴地宣布 HRS-7535 (KAI-7535) 和 HRS-4729 (KAI-4729) 的新顶线数据，反映了我们与合作伙伴共同推进多样化组合的承诺，涵盖多种机制和可注射及口服的治疗方式，以帮助满足肥胖患者多样化和不断变化的需求。”

Renaud, continued, “These achievements, combined with our successful IPO, have positioned us with the capital and operational strength to continue advancing multiple programs in parallel. We are focused on maintaining this momentum and executing across our clinical programs as we work to deliver differentiated therapies for the treatment of obesity.”

Renaud 继续说道：“这些成就，加上我们成功的首次公开募股，使我们具备了继续并行推进多个项目所需的资本和运营实力。我们专注于保持这种势头，并在我们的临床项目中执行，以努力提供差异化的肥胖治疗方案。”

First Quarter Business Highlights and Recent Developments

第一季度业务亮点和近期发展

Pipeline Highlights

管道亮点

Ribupatide injection (KAI-9531), GLP-1/GIP receptor dual agonist:
- Initiated global Phase 3 KaiNETIC program : The program encompasses three double-blind, randomized, placebo-controlled Phase 3 trials (KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3) evaluating once-weekly ribupatide injection doses of up to 10 mg over 76 weeks in adults living with obesity or overweight. Data is anticipated in 2028.
- Initiated U.S. Phase 2b high dose obesity clinical trial to evaluate the potential to achieve even greater weight loss with higher doses of ribupatide injection: The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 250 participants with a BMI of 35 or greater and no type 2 diabetes (T2D). Participants will receive either placebo or doses up to 20 mg of ribupatide injection administered over a period of 48 weeks. Data is anticipated in 2027.
- Announced data presentation at the 86th Scientific Sessions of the American Diabetes Association (ADA 2026 ) : Poster presentation will cover Kailera’s Phase 1 single ascending dose bridging study of ribupatide injection in participants of non-Asian and Asian descent, which supported the initiation of the ongoing global Phase 3 KaiNETIC clinical program.
Ribupatide oral (KAI-9531-T), GLP-1/GIP receptor dual agonist:
- Reported positive topline data from Hengrui’s Phase 2 obesity trial : Participants taking ribupatide oral achieved a mean weight loss of up to 12.1% with no observed plateau at Week 26, and up to 38.6% of participants taking ribupatide oral achieved at least 15% weight loss. Results demonstrated a potentially highly differentiated tolerability profile with low rates of gastrointestinal adverse events observed. The full data will be presented in a poster presentation at ADA 2026.
- Subject to discussions with the FDA and other regulatory agencies, Kailera plans to initiate Phase 3 global trials as early as the first half of 2027.
KAI-7535, oral small molecule GLP-1 receptor agonist:
- Initiated global Phase 2 obesity trial: The double-blind, randomized, placebo-controlled trial is expected to enroll approximately 320 participants with a BMI of 30+ or a BMI of 27+ with at least one co-morbidity, which may include T2D. Participants will receive either placebo or doses up to 360 mg of KAI-7535 administered over a period of 44 weeks. Data is anticipated in 2027.
- Reported positive topline data from OUTSTAND-1, Hengrui’s Phase 3 T2D clinical trial ( NCT06672172 ): OUTSTAND-1, the first of multiple Phase 3 trials, met the primary endpoint at Week 32, demonstrating significant HbA1c reductions across all three HRS-7535 (KAI-7535) dose levels (30 mg, 60 mg, and 90 mg) compared to placebo. The multi-center, randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy and safety of HRS-7535 in adult participants with T2D. The trial enrolled 284 participants with T2D with a mean baseline HbA1c of 7.95%, mean baseline body weight of 77.5 kg (171 lbs.) and mean body mass index (BMI) of 27.8 kg/m2and a median T2D duration of 1.60 years at baseline. Prior use of glucose-lowering medication was reported by 33.5% of the participants. The participant population was 33.1% female.
  - Based on the efficacy estimand1, HbA1c reductions ranged from 1.40% to 1.68%, compared to 0.06% for placebo. Based on the treatment policy estimand2, HbA1c reductions ranged from 1.38% to 1.63%, compared to 0.18% for placebo. HRS-7535 also demonstrated clinically meaningful benefit across multiple metabolic and organ function measures, including reduction in weight, urinary protein and blood pressure, and improvements in blood lipids.
  - The trial results demonstrated favorable safety and tolerability data consistent with oral GLP-1-based treatments and previously reported HRS-7535 Phase 2 clinical data. Most treatment-emergent adverse events (TEAEs) were mild to moderate and gastrointestinal-related. No Grade 3 hypoglycemic events were reported, and no liver safety signal was observed.
  - Hengrui intends to share the full HRS-7535 Phase 3 T2D clinical trial data at an upcoming scientific conference, and plans to submit an NDA for HRS-7535 for the treatment of T2D in China.
  - Data from Hengrui’s ongoing Phase 3 clinical trial in participants living with obesity is anticipated later this year.
KAI-4729, injectable GLP-1/GIP/glucagon receptor tri-agonist:
- Reported positive topline data from Hengrui’s Phase 1 SAD/MAD trial ( NCT06762600 ): The randomized, double-blind, placebo-controlled first-in-human trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 (KAI-4729) injection in healthy participants. The MAD portion of Phase 1 trial of KAI-4729 enrolled 60 participants with a mean baseline body weight of 87.3 kg (192 lbs) and mean baseline body mass index (BMI) of 31.4 kg/m2. Participants received once-weekly doses of 1 mg, 4 mg, 8 mg or 12 mg HRS-4729, 4 mg ribupatide (active control) or placebo for 12 weeks.
  - HRS-4729 demonstrated linear pharmacokinetics, with a half-life of approximately 4 to 5 days, supporting once-weekly dosing.
  - In the MAD portion of the trial at Week 12, participants receiving multiple doses of 12 mg of HRS-4729 achieved a mean weight loss of up to 16.0% from baseline, compared to 5.4% with placebo.
  - HRS-4729 demonstrated favorable safety and tolerability data consistent with GLP-1-based treatments. Most treatment-emergent adverse events (TEAEs) were mild to moderate and gastrointestinal-related.
  - HRS-4729 demonstrated dose-dependent reduction in liver fat content as measured by magnetic resonance imaging proton density fat fraction.
  - Hengrui intends to share the full HRS-4729 Phase 1 clinical trial data at an upcoming scientific conference.
  - Hengrui plans to advance HRS-4729 to Phase 2 clinical trials including for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH) in China, and Kailera plans to initiate a Phase 1 clinical trial outside of China in 2026, with data expected in 2027.

利布帕肽注射剂 (KAI-9531)，GLP-1/GIP 受体双重激动剂：
- 启动 全球第三阶段 KaiNETIC 项目 : 该项目包括三项双盲、随机、安慰剂对照的第三阶段试验（KaiNETIC-1、KaiNETIC-2 和 KaiNETIC-3），评估每周一次的利布帕肽注射剂剂量，最高可达 10 毫克，持续 76 周，针对生活在肥胖或超重状态的成年人。预计数据将在 2028 年公布。
- 启动美国第二阶段高剂量肥胖临床试验，以评估更高剂量的利布帕肽注射剂是否能实现更大的减重效果： 该随机、双盲、安慰剂对照试验预计将招募约 250 名 BMI 为 35 或以上且没有 2 型糖尿病 (T2D) 的参与者。参与者将接受安慰剂或最高 20 毫克的利布帕肽注射剂，持续 48 周。预计数据将在 2027 年公布。
- 宣布 在美国糖尿病协会 (ADA 2026) 第 86 届科学会议上进行数据展示： 海报展示将涵盖 Kailera 在非亚裔和亚裔参与者中进行的利布帕肽注射剂单次递增剂量桥接研究的第一阶段，该研究支持了正在进行的全球第三阶段 KaiNETIC 临床项目的启动。
利布帕肽口服剂 (KAI-9531-T)，GLP-1/GIP 受体双重激动剂：
- 报告 恒瑞的第二阶段肥胖试验的积极顶线数据： 服用利布帕肽口服剂的参与者在第 26 周实现了高达 12.1% 的平均体重减轻，并且没有观察到平台期，约 38.6% 的参与者实现了至少 15% 的体重减轻。结果显示出潜在的高度差异化的耐受性特征，观察到的胃肠道不良事件发生率较低。完整数据将在 ADA 2026 的海报展示中公布。
- 在与 FDA 和其他监管机构讨论后，Kailera 计划最早在 2027 年上半年启动第三阶段全球试验。
KAI-7535，口服小分子 GLP-1 受体激动剂：
- 启动全球第二阶段肥胖试验： 该双盲、随机、安慰剂对照试验预计将招募约 320 名 BMI 为 30 以上或 BMI 为 27 以上且至少有一种合并症（可能包括 T2D）的参与者。参与者将接受安慰剂或最高 360 毫克的 KAI-7535，持续 44 周。预计数据将在 2027 年公布。
- 报告 恒瑞的第三阶段 T2D 临床试验（NCT06672172）OUTSTAND-1 的积极顶线数据： OUTSTAND-1 是多个第三阶段试验中的第一个，在第 32 周达到了主要终点，显示出所有三种 HRS-7535 (KAI-7535) 剂量水平（30 毫克、60 毫克和 90 毫克）与安慰剂相比，HbA1c 显著降低。该多中心、随机、双盲、安慰剂对照试验旨在评估 HRS-7535 在 T2D 成人参与者中的疗效和安全性。试验招募了 284 名 T2D 参与者，基线 HbA1c 平均值为 7.95%，基线体重平均值为 77.5 公斤（171 磅），基线体重指数 (BMI) 平均值为 27.8 kg/m2，基线 T2D 持续时间中位数为 1.60 年。33.5% 的参与者报告曾使用降糖药物。参与者中女性占比为 33.1%。
  - 根据疗效估计，HbA1c 降低范围为 1.40% 至 1.68%，而安慰剂为 0.06%。根据治疗政策估计，HbA1c 降低范围为 1.38% 至 1.63%，而安慰剂为 0.18%。HRS-7535 在多个代谢和器官功能指标上也显示出临床意义的益处，包括体重、尿蛋白和血压的降低，以及血脂的改善。
  - 试验结果显示出与口服 GLP-1 基础治疗一致的良好安全性和耐受性数据，之前报告的 HRS-7535 第二阶段临床数据也显示出相似结果。大多数治疗相关不良事件 (TEAEs) 为轻度至中度，且与胃肠道相关。未报告 3 级低血糖事件，且未观察到肝脏安全信号。
  - 恒瑞计划在即将召开的科学会议上分享完整的 HRS-7535 第三阶段 T2D 临床试验数据，并计划在中国提交 HRS-7535 的新药申请 (NDA) 用于 T2D 的治疗。
  - 恒瑞正在进行的第三阶段临床试验中，生活在肥胖状态的参与者的数据预计将在今年晚些时候公布。
KAI-4729，注射用 GLP-1/GIP/胰高血糖素受体三重激动剂：
- 报告 恒瑞的第一阶段 SAD/MAD 试验（NCT06762600）的积极顶线数据： 该随机、双盲、安慰剂对照的首次人体试验评估了 HRS-4729 (KAI-4729) 注射剂在健康参与者中的安全性、耐受性、药代动力学和药效学。KAI-4729 第一阶段试验的 MAD 部分招募了 60 名参与者，基线体重平均值为 87.3 公斤（192 磅），基线 BMI 平均值为 31.4 kg/m2。参与者每周接受 1 毫克、4 毫克、8 毫克或 12 毫克的 HRS-4729、4 毫克的利布帕肽（活性对照）或安慰剂，持续 12 周。
  - HRS-4729 显示出线性药代动力学，半衰期约为 4 到 5 天，支持每周一次给药。
  - 在试验的 MAD 部分，第 12 周，接受多次 12 毫克 HRS-4729 的参与者实现了高达 16.0% 的体重减轻，而安慰剂组为 5.4%。
  - HRS-4729 显示出与 GLP-1 基础治疗一致的良好安全性和耐受性数据。大多数治疗相关不良事件 (TEAEs) 为轻度至中度，且与胃肠道相关。
  - HRS-4729 显示出剂量依赖性降低肝脏脂肪含量，使用磁共振成像质子密度脂肪分数进行测量。
  - 恒瑞计划在即将召开的科学会议上分享完整的 HRS-4729 第一阶段临床试验数据。
  - 恒瑞计划将 HRS-4729 推进至第二阶段临床试验，包括在中国用于肥胖和代谢功能障碍相关脂肪肝炎 (MASH) 的治疗，Kailera 计划在 2026 年在中国以外启动第一阶段临床试验，预计数据将在 2027 年公布。

Corporate Highlights

公司亮点

Expanded leadership team with key appointments:
- Appointed Martin Mackay, Ph.D. and Shelley Liu, Ph.D to Board of Directors. Dr. Mackay brings more than 30 years of biopharmaceutical leadership experience overseeing research and development (R&D) across leading pharmaceutical and biotechnology companies and helping to advance transformative medicines across multiple therapeutic areas and through every stage of development. Dr. Liu, China Head of Corporate Development at Hengrui, brings expertise in evaluating R&D innovation and advising on corporate development strategy across the healthcare industry.
Closed $718.8M Initial Public Offering:
- Closed initial public offering of 44,921,875 shares of its common stock at the initial public offering price of $16.00 per share. All of the shares of common stock were offered by Kailera and gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $718.8 million. Kailera began trading on the Nasdaq Global Select Market under the ticker symbol “KLRA” on April 17, 2026.

扩展领导团队，进行关键任命：
- 任命马丁·麦凯博士（Martin Mackay, Ph.D.）和刘雪莉博士（Shelley Liu, Ph.D.）为董事会成员。麦凯博士拥有超过 30 年的生物制药领导经验，曾在领先的制药和生物技术公司监督研发（R&D），并帮助推动多个治疗领域的变革性药物的开发。刘博士是恒瑞医药的中国企业发展负责人，擅长评估研发创新并为医疗行业的企业发展战略提供建议。
完成 7.188 亿美元首次公开募股：
- 完成了 44921875 股普通股的首次公开募股，首次公开募股价格为每股 16.00 美元。所有普通股均由 Kailera 提供，募股的总收入在扣除承销折扣和佣金及其他募股费用之前为 7.188 亿美元。Kailera 于2026年4月17日在纳斯达克全球精选市场以 “KLRA” 股票代码开始交易。

Anticipated Key Milestones

预期关键里程碑

Ribupatide injection: U.S. Phase 2b high dose obesity data anticipated in 2027; global Phase 3 obesity data anticipated in 2028
Ribupatide oral: Initiate global Phase 3 obesity trials as early as 1H’2027
KAI-7535: Global Phase 2 obesity data anticipated in 2027
KAI-4729: Initiate Phase 1 trial by end of year 2026; data anticipated in 2027

Ribupatide 注射剂： 预计 2027 年发布美国 2b 期高剂量肥胖数据；预计 2028 年发布全球 3 期肥胖数据
Ribupatide 口服剂： 预计最早在 2027 年上半年启动全球 3 期肥胖试验
KAI-7535： 预计 2027 年发布全球 2 期肥胖数据
KAI-4729： 预计在 2026 年底前启动 1 期试验；预计 2027 年发布数据

First Quarter 2026 Financial Results

2026 年第一季度财务结果

As of March 31, 2026, Kailera had cash, cash equivalents and marketable securities of $581.9 million, which, together with the $718.8 million of gross proceeds raised as part of its initial public offering, is expected to fund operations into mid-2028.

截至2026年3月31日，Kailera 的现金、现金等价物和可交易证券为 5.819 亿美元，加上首次公开募股筹集的 7.188 亿美元总收入，预计将资助运营至 2028 年中期。

R&D expenses were $70.9 million for the quarter ended March 31, 2026, compared to $10.1 million for the same period in 2025. The increase of $60.7 million was primarily driven by the increase in product candidate development and the related nonclinical, clinical, and contract manufacturing costs associated with the Company's portfolio, as well as the increase in personnel-related costs to support its ongoing R&D activities.

截至2026年3月31日的季度研发费用为 7090 万美元，而 2025 年同期为 1010 万美元。增加的 6070 万美元主要是由于产品候选开发的增加以及与公司投资组合相关的非临床、临床和合同制造成本的增加，以及支持其持续研发活动的人事相关费用的增加。

General and administrative expenses were $13.8 million for the quarter ended March 31, 2026, compared to $10.3 million for the same period in 2025. The increase of $3.5 million was primarily driven by personnel-related costs and professional service costs as the Company continues to expand its operations.

截至2026年3月31日的季度一般和行政费用为 1380 万美元，而 2025 年同期为 1030 万美元。增加的 350 万美元主要是由于人事相关费用和专业服务费用的增加，因为公司继续扩展其运营。

Net loss was $78.9 million for the quarter ended March 31, 2026, compared to a net loss of $18.0 million for the same period in 2025.

截至2026年3月31日的季度净亏损为 7890 万美元，而 2025 年同期的净亏损为 1800 万美元。

Upcoming Events

即将举行的活动

Kailera expects to participate in the following investor conferences and medical congresses:

Kailera 预计将参加以下投资者会议和医学大会：

Jefferies Global Healthcare Conference – June 4, 2026
American Diabetes Association Scientific Sessions – June 5-8, 2026

Jefferies 全球医疗会议 –2026年6月4日
美国糖尿病协会科学会议 – 2026 年 6 月 5-8 日

About Kailera Therapeutics

关于 Kailera Therapeutics

Kailera Therapeutics (Kailera) is a clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate, ribupatide injection (also known as KAI-9531), that has the potential for the greatest weight loss. Ribupatide injection is in global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist. Kailera is expanding the ribupatide franchise by developing a once-daily oral formulation with the goal of providing an oral option with the potential for compelling weight loss and highly differentiated tolerability. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA. For more information, visit www.kailera.com and follow us on LinkedIn and X.

Kailera Therapeutics（Kailera）是一家临床阶段的生物技术公司，专注于通过推进多样化的产品管线来提升肥胖护理的下一个时代，为生活在肥胖中的人们提供选择，无论他们在治疗旅程的哪个阶段。Kailera 以肥胖为首要关注点，正在推进四个临床阶段的产品候选，利用多种基于 GLP-1 的作用机制和给药途径，专门设计以满足当前治疗领域的关键需求，主要产品候选为 Ribupatide 注射剂（也称为 KAI-9531），具有最大的减重潜力。Ribupatide 注射剂正在进行全球 3 期试验，作为每周一次的 GLP-1/GIP 受体双激动剂。Kailera 正在通过开发每日一次的口服制剂来扩展 Ribupatide 系列，目标是提供一种具有显著减重潜力和高度差异化耐受性的口服选择。此外，Kailera 还在推进 KAI-7535 的开发，这是一种每日一次的口服小分子 GLP-1 受体激动剂，以及 KAI-4729，这是一种每周一次的 GLP-1/GIP/胰高血糖素受体三重激动剂。Kailera 的愿景是提供领先类别的肥胖管理药物，使人们能够恢复健康，改变生活。Kailera 总部位于马萨诸塞州沃尔瑟姆。有关更多信息，请访问 www.kailera.com，并在 LinkedIn 和 X 上关注我们。

Special Note Regarding Kailera Forward-Looking Statements

关于 Kailera 前瞻性声明的特别说明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the profile of product candidates, the potential of Kailera’s portfolio, the timing, design and outcome of research and development activities, market opportunities for product candidates, the competitive landscape, timing and format of sharing of full clinical trial data, future results of operations and financial position, sufficiency of cash on hand to fund operations, and participation in upcoming events or presentations. Forward-looking statements can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," “suggest,” "plan," “goal,” “vision,” "potential," "predict," "project," "should," "target," "will," "would," or similar expressions and the negatives of those terms. Kailera cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in clinical development, regulatory review, manufacturing, competition, market opportunities, reliance on third parties, estimates of capital requirements, needs for additional financing, and other important factors, including those discussed under the caption “Risk Factors” in Kailera’s filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release, and Kailera undertakes no obligation to update or revise any forward-looking statements. Kailera may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements.

本新闻稿包含 1995 年《私人证券诉讼改革法案》所定义的前瞻性声明，这些声明涉及重大风险和不确定性。本新闻稿中所有与历史事实无关的声明应视为前瞻性声明，包括但不限于关于产品候选者的概况、Kailera 投资组合的潜力、研发活动的时间、设计和结果、产品候选者的市场机会、竞争格局、完整临床试验数据分享的时间和形式、未来的运营结果和财务状况、手头现金是否足以支持运营，以及参与即将举行的活动或演示。前瞻性声明可以通过诸如 “预期”、“相信”、“考虑”、“继续”、“可能”、“估计”、“期望”、“打算”、“或许”、“建议”、“计划”、“目标”、“愿景”、“潜力”、“预测”、“项目”、“应该”、“目标”、“将”、“会” 或类似表达及其否定形式来识别。Kailera 无法保证本新闻稿中的前瞻性声明将被证明是准确的。本新闻稿中的信息也可能包括与过去表现相关的声明，这些声明不应被视为未来表现的可靠指标。前瞻性声明基于当前的期望和假设，以及对未来的预测，这些预测本质上是不确定的，并涉及可能导致实际结果与所表达或暗示的结果有重大差异的风险和不确定性。这些风险和不确定性包括但不限于临床开发、监管审查、制造、竞争、市场机会、对第三方的依赖、资本需求的估计、对额外融资的需求以及其他重要因素，包括在 Kailera 向证券交易委员会提交的文件中讨论的 “风险因素” 标题下的因素。这些声明仅在本新闻稿日期有效，Kailera 不承担更新或修订任何前瞻性声明的义务。Kailera 可能无法实际实现其在前瞻性声明中披露的计划、意图或期望，您不应对这些前瞻性声明过于依赖。

1 Based on the efficacy estimand, which was pre-specified as the supplementary estimand: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other glucose-lowering medications from the analysis.

1 基于疗效估计量，该估计量被预先指定为补充估计量：假设参与者遵循协议治疗的治疗效果，并排除在提前停止治疗或使用其他降糖药物后收集的数据。

2__Based on the treatment policy estimand: treatment effect including the impact of premature discontinuations or use of other glucose-lowering medications therapies.

2__基于治疗政策估计量：包括提前停止或使用其他降糖药物治疗的影响的治疗效果。

Contact Information

联系信息

Maura Gavaghan

Vice President, Corporate Communications and Investor Relations

副总裁，企业传播与投资者关系

maura.gavaghan@kailera.com


KAILERA THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) (UNAUDITED)

	March 31, 2026		December 31, 2025

Assets
Current assets:
Cash and cash equivalents	$	111,826		$	160,267
Marketable securities		407,348			385,789
Prepaid expenses and other current assets		11,141			11,481
Total current assets		530,315			557,537
Property and equipment, net		1,854			1,955
Restricted cash		761			761
Long-term marketable securities		62,747			106,672
Non-current clinical deposits		13,318			12,185
Operating lease right-of-use assets		10,170			10,463
Other non-current assets		5,591			2,721
Total assets	$	624,756		$	692,294
Liabilities, convertible preferred stock and stockholders’ deficit
Current liabilities:
Accounts payable	$	7,095		$	7,529
Accrued expenses and other current liabilities		46,714			37,836
Operating lease liabilities, current		1,027			1,040
Total current liabilities		54,836			46,405
Operating lease liabilities, non-current		9,443			9,713
Other non-current liabilities		201			270
Total liabilities		64,480			56,388
Commitments and contingencies
Convertible preferred stock:
Series A convertible preferred stock		390,306			390,306
Series B convertible preferred stock		602,058			602,058
Stockholders’ deficit:
Common stock		—			—
Additional paid-in capital		15,977			11,981
Accumulated other comprehensive (loss) income		(532	)		229
Accumulated deficit		(447,533	)		(368,668	)
Total stockholders’ deficit		(432,088	)		(356,458	)
Total liabilities, convertible preferred stock and stockholders’ deficit	$	624,756		$	692,294


KAILERA THERAPEUTICS, INC.
简明合并资产负债表
**（单位：千美元）
**（未经审计）
	2026年3月31日		2025年12月31日

资产
流动资产：
现金及现金等价物	$	111,826		$	160,267
可交易证券		407,348			385,789
预付费用及其他流动资产		11,141			11,481
流动资产总计		530,315			557,537
固定资产净值		1,854			1,955
限制性现金		761			761
长期可交易证券		62,747			106,672
非流动临床存款		13,318			12,185
租赁使用权资产		10,170			10,463
其他非流动资产		5,591			2,721
资产总计	$	624,756		$	692,294
负债、可转换优先股及股东赤字
流动负债：
应付账款	$	7,095		$	7,529
应计费用及其他流动负债		46,714			37,836
租赁负债（流动）		1,027			1,040
流动负债总计		54,836			46,405
租赁负债（非流动）		9,443			9,713
其他非流动负债		201			270
负债总计		64,480			56,388
承诺和或有事项
可转换优先股：
A 系列可转换优先股		390,306			390,306
B 系列可转换优先股		602,058			602,058
股东赤字：
普通股		—			—
额外实收资本		15,977			11,981
累计其他综合（损失）收益		(532	)		229
累计赤字		(447,533	)		(368,668	)
股东赤字总计		(432,088	)		(356,458	)
负债、可转换优先股及股东赤字总计	$	624,756		$	692,294


KAILERA THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS) (UNAUDITED)

	Three Months Ended March 31,
		2026			2025
Operating expenses
Research and development	$	70,873		$	10,130
General and administrative		13,787			10,328
Total operating expenses		84,660			20,458
Loss from operations		(84,660	)		(20,458	)
Other income
Interest income		5,716			1,675
Other income, net		79			800
Total other income		5,795			2,475
Net loss	$	(78,865	)	$	(17,983	)


KAILERA THERAPEUTICS, INC. 简明合并经营报表（单位：千美元）（未经审计）

	截至 3 月 31 日的三个月
		2026			2025
营业费用
研发费用	$	70,873		$	10,130
一般及行政费用		13,787			10,328
总营业费用		84,660			20,458
营业损失		(84,660	)		(20,458	)
其他收入
利息收入		5,716			1,675
其他净收入		79			800
总其他收入		5,795			2,475
净亏损	$	(78,865	)	$	(17,983	)

Kailera 公布 2026 年第一季度财务业绩并更新临床数据 | KLRA 股票新闻