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

在四個臨牀階段項目中取得重要進展，展示了肥胖藥物研發的深度和廣度
啓動了五項晚期全球臨牀試驗，涉及肥胖治療，包括 ribupatide 注射劑 KaiNETIC 三期項目
報告了我們在中國的合作伙伴恆瑞醫藥進行的三項試驗的積極頂線臨牀數據， 包括針對 2 型糖尿病的口服小分子 GLP-1 受體激動劑 HRS-7535 (KAI-7535) 的三期試驗的新頂線數據，以及針對可注射三重激動劑 HRS-4729 (KAI-4729) 的首次人體三期試驗的頂線數據
手頭現金，包括首次公開募股的收益，預計將支持運營至 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.

馬薩諸塞州沃爾瑟姆，2026年5月26日（全球新聞通訊社）-- Kailera Therapeutics, Inc.（納斯達克：KLRA）（Kailera）是一家專注於提升肥胖護理下一個時代的臨牀階段生物技術公司，今天報告了截至2026年3月31日的第一季度財務業績，並提供了近期業務亮點的總結。

“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，我們繼續建立有意義的勢頭，並在推進我們的臨牀組合方面取得了重大進展，包括啓動多個臨牀試驗和報告重要的數據結果，進一步強調了我們管道的廣度、深度和潛力，” Kailera 的總裁兼首席執行官 Ron Renaud 表示。“重要的是，我們的 ribupatide 系列繼續在肥胖管理藥物中展示出領先的潛力，特別是通過啓動全球 KaiNETIC 三期項目和在中國獲得的 ribupatide 口服劑的積極二期數據。我們也很高興地宣佈 HRS-7535 (KAI-7535) 和 HRS-4729 (KAI-4729) 的新頂線數據，反映了我們與合作伙伴共同推進多樣化組合的承諾，涵蓋多種機制和可注射及口服的治療方式，以幫助滿足肥胖患者多樣化和不斷變化的需求。”

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 繼續説道：“這些成就，加上我們成功的首次公開募股，使我們具備了繼續並行推進多個項目所需的資本和運營實力。我們專注於保持這種勢頭，並在我們的臨牀項目中執行，以努力提供差異化的肥胖治療方案。”

First Quarter Business Highlights and Recent Developments

第一季度業務亮點和近期發展

Pipeline Highlights

管道亮點

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.

利布帕肽注射劑 (KAI-9531)，GLP-1/GIP 受體雙重激動劑：
- 啓動 全球第三階段 KaiNETIC 項目 : 該項目包括三項雙盲、隨機、安慰劑對照的第三階段試驗（KaiNETIC-1、KaiNETIC-2 和 KaiNETIC-3），評估每週一次的利布帕肽注射劑劑量，最高可達 10 毫克，持續 76 周，針對生活在肥胖或超重狀態的成年人。預計數據將在 2028 年公佈。
- 啓動美國第二階段高劑量肥胖臨牀試驗，以評估更高劑量的利布帕肽注射劑是否能實現更大的減重效果： 該隨機、雙盲、安慰劑對照試驗預計將招募約 250 名 BMI 為 35 或以上且沒有 2 型糖尿病 (T2D) 的參與者。參與者將接受安慰劑或最高 20 毫克的利布帕肽注射劑，持續 48 周。預計數據將在 2027 年公佈。
- 宣佈 在美國糖尿病協會 (ADA 2026) 第 86 屆科學會議上進行數據展示： 海報展示將涵蓋 Kailera 在非亞裔和亞裔參與者中進行的利布帕肽注射劑單次遞增劑量橋接研究的第一階段，該研究支持了正在進行的全球第三階段 KaiNETIC 臨牀項目的啓動。
利布帕肽口服劑 (KAI-9531-T)，GLP-1/GIP 受體雙重激動劑：
- 報告 恆瑞的第二階段肥胖試驗的積極頂線數據： 服用利布帕肽口服劑的參與者在第 26 周實現了高達 12.1% 的平均體重減輕，並且沒有觀察到平台期，約 38.6% 的參與者實現了至少 15% 的體重減輕。結果顯示出潛在的高度差異化的耐受性特徵，觀察到的胃腸道不良事件發生率較低。完整數據將在 ADA 2026 的海報展示中公佈。
- 在與 FDA 和其他監管機構討論後，Kailera 計劃最早在 2027 年上半年啓動第三階段全球試驗。
KAI-7535，口服小分子 GLP-1 受體激動劑：
- 啓動全球第二階段肥胖試驗： 該雙盲、隨機、安慰劑對照試驗預計將招募約 320 名 BMI 為 30 以上或 BMI 為 27 以上且至少有一種合併症（可能包括 T2D）的參與者。參與者將接受安慰劑或最高 360 毫克的 KAI-7535，持續 44 周。預計數據將在 2027 年公佈。
- 報告 恆瑞的第三階段 T2D 臨牀試驗（NCT06672172）OUTSTAND-1 的積極頂線數據： OUTSTAND-1 是多個第三階段試驗中的第一個，在第 32 周達到了主要終點，顯示出所有三種 HRS-7535 (KAI-7535) 劑量水平（30 毫克、60 毫克和 90 毫克）與安慰劑相比，HbA1c 顯著降低。該多中心、隨機、雙盲、安慰劑對照試驗旨在評估 HRS-7535 在 T2D 成人蔘與者中的療效和安全性。試驗招募了 284 名 T2D 參與者，基線 HbA1c 平均值為 7.95%，基線體重平均值為 77.5 公斤（171 磅），基線體重指數 (BMI) 平均值為 27.8 kg/m2，基線 T2D 持續時間中位數為 1.60 年。33.5% 的參與者報告曾使用降糖藥物。參與者中女性佔比為 33.1%。
  - 根據療效估計，HbA1c 降低範圍為 1.40% 至 1.68%，而安慰劑為 0.06%。根據治療政策估計，HbA1c 降低範圍為 1.38% 至 1.63%，而安慰劑為 0.18%。HRS-7535 在多個代謝和器官功能指標上也顯示出臨牀意義的益處，包括體重、尿蛋白和血壓的降低，以及血脂的改善。
  - 試驗結果顯示出與口服 GLP-1 基礎治療一致的良好安全性和耐受性數據，之前報告的 HRS-7535 第二階段臨牀數據也顯示出相似結果。大多數治療相關不良事件 (TEAEs) 為輕度至中度，且與胃腸道相關。未報告 3 級低血糖事件，且未觀察到肝臟安全信號。
  - 恆瑞計劃在即將召開的科學會議上分享完整的 HRS-7535 第三階段 T2D 臨牀試驗數據，並計劃在中國提交 HRS-7535 的新藥申請 (NDA) 用於 T2D 的治療。
  - 恆瑞正在進行的第三階段臨牀試驗中，生活在肥胖狀態的參與者的數據預計將在今年晚些時候公佈。
KAI-4729，注射用 GLP-1/GIP/胰高血糖素受體三重激動劑：
- 報告 恆瑞的第一階段 SAD/MAD 試驗（NCT06762600）的積極頂線數據： 該隨機、雙盲、安慰劑對照的首次人體試驗評估了 HRS-4729 (KAI-4729) 注射劑在健康參與者中的安全性、耐受性、藥代動力學和藥效學。KAI-4729 第一階段試驗的 MAD 部分招募了 60 名參與者，基線體重平均值為 87.3 公斤（192 磅），基線 BMI 平均值為 31.4 kg/m2。參與者每週接受 1 毫克、4 毫克、8 毫克或 12 毫克的 HRS-4729、4 毫克的利布帕肽（活性對照）或安慰劑，持續 12 周。
  - HRS-4729 顯示出線性藥代動力學，半衰期約為 4 到 5 天，支持每週一次給藥。
  - 在試驗的 MAD 部分，第 12 周，接受多次 12 毫克 HRS-4729 的參與者實現了高達 16.0% 的體重減輕，而安慰劑組為 5.4%。
  - HRS-4729 顯示出與 GLP-1 基礎治療一致的良好安全性和耐受性數據。大多數治療相關不良事件 (TEAEs) 為輕度至中度，且與胃腸道相關。
  - HRS-4729 顯示出劑量依賴性降低肝臟脂肪含量，使用磁共振成像質子密度脂肪分數進行測量。
  - 恆瑞計劃在即將召開的科學會議上分享完整的 HRS-4729 第一階段臨牀試驗數據。
  - 恆瑞計劃將 HRS-4729 推進至第二階段臨牀試驗，包括在中國用於肥胖和代謝功能障礙相關脂肪肝炎 (MASH) 的治療，Kailera 計劃在 2026 年在中國以外啓動第一階段臨牀試驗，預計數據將在 2027 年公佈。

Corporate Highlights

公司亮點

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.

擴展領導團隊，進行關鍵任命：
- 任命馬丁·麥凱博士（Martin Mackay, Ph.D.）和劉雪莉博士（Shelley Liu, Ph.D.）為董事會成員。麥凱博士擁有超過 30 年的生物製藥領導經驗，曾在領先的製藥和生物技術公司監督研發（R&D），並幫助推動多個治療領域的變革性藥物的開發。劉博士是恆瑞醫藥的中國企業發展負責人，擅長評估研發創新併為醫療行業的企業發展戰略提供建議。
完成 7.188 億美元首次公開募股：
- 完成了 44921875 股普通股的首次公開募股，首次公開募股價格為每股 16.00 美元。所有普通股均由 Kailera 提供，募股的總收入在扣除承銷折扣和佣金及其他募股費用之前為 7.188 億美元。Kailera 於2026年4月17日在納斯達克全球精選市場以 “KLRA” 股票代碼開始交易。

Anticipated Key Milestones

預期關鍵里程碑

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 注射劑： 預計 2027 年發佈美國 2b 期高劑量肥胖數據；預計 2028 年發佈全球 3 期肥胖數據
Ribupatide 口服劑： 預計最早在 2027 年上半年啓動全球 3 期肥胖試驗
KAI-7535： 預計 2027 年發佈全球 2 期肥胖數據
KAI-4729： 預計在 2026 年底前啓動 1 期試驗；預計 2027 年發佈數據

First Quarter 2026 Financial Results

2026 年第一季度財務結果

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 的現金、現金等價物和可交易證券為 5.819 億美元，加上首次公開募股籌集的 7.188 億美元總收入，預計將資助運營至 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日的季度研發費用為 7090 萬美元，而 2025 年同期為 1010 萬美元。增加的 6070 萬美元主要是由於產品候選開發的增加以及與公司投資組合相關的非臨牀、臨牀和合同製造成本的增加，以及支持其持續研發活動的人事相關費用的增加。

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費用為 1380 萬美元，而 2025 年同期為 1030 萬美元。增加的 350 萬美元主要是由於人事相關費用和專業服務費用的增加，因為公司繼續擴展其運營。

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日的季度淨虧損為 7890 萬美元，而 2025 年同期的淨虧損為 1800 萬美元。

Upcoming Events

即將舉行的活動

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

Kailera 預計將參加以下投資者會議和醫學大會：

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

Jefferies 全球醫療會議 –2026年6月4日
美國糖尿病協會科學會議 – 2026 年 6 月 5-8 日

About Kailera Therapeutics

關於 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）是一家臨牀階段的生物技術公司，專注於通過推進多樣化的產品管線來提升肥胖護理的下一個時代，為生活在肥胖中的人們提供選擇，無論他們在治療旅程的哪個階段。Kailera 以肥胖為首要關注點，正在推進四個臨牀階段的產品候選，利用多種基於 GLP-1 的作用機制和給藥途徑，專門設計以滿足當前治療領域的關鍵需求，主要產品候選為 Ribupatide 注射劑（也稱為 KAI-9531），具有最大的減重潛力。Ribupatide 注射劑正在進行全球 3 期試驗，作為每週一次的 GLP-1/GIP 受體雙激動劑。Kailera 正在通過開發每日一次的口服制劑來擴展 Ribupatide 系列，目標是提供一種具有顯著減重潛力和高度差異化耐受性的口服選擇。此外，Kailera 還在推進 KAI-7535 的開發，這是一種每日一次的口服小分子 GLP-1 受體激動劑，以及 KAI-4729，這是一種每週一次的 GLP-1/GIP/胰高血糖素受體三重激動劑。Kailera 的願景是提供領先類別的肥胖管理藥物，使人們能夠恢復健康，改變生活。Kailera 總部位於馬薩諸塞州沃爾瑟姆。有關更多信息，請訪問 www.kailera.com，並在 LinkedIn 和 X 上關注我們。

Special Note Regarding Kailera Forward-Looking Statements

關於 Kailera 前瞻性聲明的特別説明

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.

本新聞稿包含 1995 年《私人證券訴訟改革法案》所定義的前瞻性聲明，這些聲明涉及重大風險和不確定性。本新聞稿中所有與歷史事實無關的聲明應視為前瞻性聲明，包括但不限於關於產品候選者的概況、Kailera 投資組合的潛力、研發活動的時間、設計和結果、產品候選者的市場機會、競爭格局、完整臨牀試驗數據分享的時間和形式、未來的運營結果和財務狀況、手頭現金是否足以支持運營，以及參與即將舉行的活動或演示。前瞻性聲明可以通過諸如 “預期”、“相信”、“考慮”、“繼續”、“可能”、“估計”、“期望”、“打算”、“或許”、“建議”、“計劃”、“目標”、“願景”、“潛力”、“預測”、“項目”、“應該”、“目標”、“將”、“會” 或類似表達及其否定形式來識別。Kailera 無法保證本新聞稿中的前瞻性聲明將被證明是準確的。本新聞稿中的信息也可能包括與過去表現相關的聲明，這些聲明不應被視為未來表現的可靠指標。前瞻性聲明基於當前的期望和假設，以及對未來的預測，這些預測本質上是不確定的，並涉及可能導致實際結果與所表達或暗示的結果有重大差異的風險和不確定性。這些風險和不確定性包括但不限於臨牀開發、監管審查、製造、競爭、市場機會、對第三方的依賴、資本需求的估計、對額外融資的需求以及其他重要因素，包括在 Kailera 向證券交易委員會提交的文件中討論的 “風險因素” 標題下的因素。這些聲明僅在本新聞稿日期有效，Kailera 不承擔更新或修訂任何前瞻性聲明的義務。Kailera 可能無法實際實現其在前瞻性聲明中披露的計劃、意圖或期望，您不應對這些前瞻性聲明過於依賴。

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 基於療效估計量，該估計量被預先指定為補充估計量：假設參與者遵循協議治療的治療效果，並排除在提前停止治療或使用其他降糖藥物後收集的數據。

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

2__基於治療政策估計量：包括提前停止或使用其他降糖藥物治療的影響的治療效果。

Contact Information

聯繫信息

Maura Gavaghan

Vice President, Corporate Communications and Investor Relations

副總裁，企業傳播與投資者關係

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.
簡明合併資產負債表
**（單位：千美元）
**（未經審計）
	2026年3月31日		2025年12月31日

資產
流動資產：
現金及現金等價物	$	111,826		$	160,267
可交易證券		407,348			385,789
預付費用及其他流動資產		11,141			11,481
流動資產總計		530,315			557,537
固定資產淨值		1,854			1,955
限制性現金		761			761
長期可交易證券		62,747			106,672
非流動臨牀存款		13,318			12,185
租賃使用權資產		10,170			10,463
其他非流動資產		5,591			2,721
資產總計	$	624,756		$	692,294
負債、可轉換優先股及股東赤字
流動負債：
應付賬款	$	7,095		$	7,529
應計費用及其他流動負債		46,714			37,836
租賃負債（流動）		1,027			1,040
流動負債總計		54,836			46,405
租賃負債（非流動）		9,443			9,713
其他非流動負債		201			270
負債總計		64,480			56,388
承諾和或有事項
可轉換優先股：
A 系列可轉換優先股		390,306			390,306
B 系列可轉換優先股		602,058			602,058
股東赤字：
普通股		—			—
額外實收資本		15,977			11,981
累計其他綜合（損失）收益		(532	)		229
累計赤字		(447,533	)		(368,668	)
股東赤字總計		(432,088	)		(356,458	)
負債、可轉換優先股及股東赤字總計	$	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. 簡明合併經營報表（單位：千美元）（未經審計）

	截至 3 月 31 日的三個月
		2026			2025
營業費用
研發費用	$	70,873		$	10,130
一般及行政費用		13,787			10,328
總營業費用		84,660			20,458
營業損失		(84,660	)		(20,458	)
其他收入
利息收入		5,716			1,675
其他淨收入		79			800
總其他收入		5,795			2,475
淨虧損	$	(78,865	)	$	(17,983	)

Kailera 公佈 2026 年第一季度財務業績並更新臨牀數據 | KLRA 股票新聞