KT-621, a potent, selective, oral STAT6 degrader, demonstrated comparable or superior activity to dupilumab in a newly disclosed preclinical chronic asthma model reversing disease progression KT-621 Phase 1 healthy volunteer SAD/MAD trial completed with data to be reported in June 2025 KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) ongoing with data expected in 4Q25 Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively WATERTOWN, Mass., May ...

纪要涉及的公司 Chimera公司，是一家临床阶段的生物科技公司 [1][6] 纪要提到的核心观点和论据 1. **与FDA的互动**：公司与美国及其他国家的监管机构有持续互动，目前未发现直接互动有实质性变化 [5] 2. **生产布局** - 公司业务分布在不同国家，在马萨诸塞州的Weathertown有大量业务，部分原材料全球采购，未来商业化产品将在美国生产 [6][7] - 美国目前缺乏支持生物制药行业药物制造的基础设施，公司会在有产能的地方进行生产，若美国加大基础研究和基础设施投资，公司会积极推动生产本土化 [8][9] 3. **下半年催化剂** - 6月将公布KT621健康志愿者数据，该研究已完成最后一组多次递增剂量（MAD）的给药，正在收集剩余数据，公司承诺展示全部SADEMMAD数据 [14] - STAT6项目独特，是首个进入临床的STAT6导向药物，目标产品能在血液和皮肤中安全降解90%以上的STAT6，若能展示该特性，将大大降低该资产的风险 [15][16] 4. **健康志愿者研究详情** - 药物每日给药一次，采用单次递增剂量和多次递增剂量，持续14天，以评估安全性、药代动力学（PK）和STAT6降解情况 [17] - 最重要的生物标志物是STAT6降解，可直接衡量靶点结合；还会关注TARC等下游生物标志物，但在健康志愿者中较难解读，预计数据与度普利尤单抗（dupilumab）处于同一范围 [19][20][21] 5. **患者研究进展** - 4月已启动Ib期研究并给药首位患者，预计第四季度完成，该研究针对特应性皮炎（AD）患者，AD是高度Th2偏向性疾病，度普利尤单抗在AD患者中显示出强大且可重复的信号 [25] - 预计第四季度公布Ib期AD患者数据，目标入组约20名患者，研究为开放标签，期望药物在生物标志物和疗效方面表现与度普利尤单抗相似 [48][49][52] 6. **成功可能性与降解阈值** - 临床前研究表明，若能在健康志愿者中展示对靶点的强力且安全的降解，预计在患者中会有强大疗效 [28] - 目前不确定不同适应症（如AD和哮喘）的降解阈值是否不同，公司希望在IIb期研究中探索，猜测两者阈值相同 [31] 7. **安全性** - 过去IRAK4药物（KT474）有良好的安全概况，主要是轻度不良事件（AEs），最常见的是头痛，预计STAT6药物与IRAK4药物的AEs无重叠 [34] - 广泛的临床前安全研究未发现STAT6药物有不良事件，人类遗传学研究也未显示特定关注问题，不期望出现QT间期延长等问题 [36][37][39] 8. **竞争格局** - 目前AD领域唯一获批的口服药物是JAK抑制剂，存在安全问题和用药前检测的复杂性；其他口服药物数据有限，STAT6降解剂是唯一针对Th2特异性炎症的药物 [40][41] - Corvus的ITK药物数据尚早，机制不同，不太可能成为直接竞争对手，市场有机会因多种药物而扩大 [44][45][46] 9. **起效时间**：药物起效时间受IL - 4/13药理学和靶点完全结合的生物学过程驱动，期望有类似度普利尤单抗的效果，需通过研究确定 [47] 10. **STAT6降解与抑制的差异** - 阻断STAT6信号的目标是阻止信号从受体传递到细胞核，降解STAT6比抑制STAT6更能完全阻断信号 [58] - 公司的催化降解剂能以相对低的剂量（约1mg/kg）在单次每日口服给药下实现90%以上的降解，而小分子抑制剂难以达到持续高于靶点表达的暴露水平 [59][60] 11. **数据结果应对策略** - 若数据不理想，可能是分子问题，公司有多个分子和下一代分子，会使用其他工具继续推进项目 [61][62] - 若数据良好，将在度普利尤单抗获批的所有适应症中开发该药物，可并行开展多个III期研究，主要取决于能力和资金 [63] 12. **肿瘤学业务**：公司过去几年关注肿瘤学，几年前决定主要聚焦免疫学，有一些临床资产有有趣的早期数据，合作事宜不确定何时及如何进行，但并非近期必要事项 [65][66][67] 13. **现金状况**：截至第一季度末，公司有7.75亿美元现金，可支撑到2028年上半年，能覆盖多个数据读出，包括STAT6项目的IIb期研究 [69] 其他重要但是可能被忽略的内容 - 度普利尤单抗在AD患者中给药28天后，TARC有70% - 80%的降低，且在患者皮肤病变中，度普利尤单抗调节的基因特征与EASI评分高度相关 [25][26] - 公司IRAK4降解剂将在明年进行ADA安慰剂对照随机试验 [40]

行业动态 - 生物技术、制药和医疗保健行业的股票动态和关键趋势是关注重点 [1] - 行业分析师提供每周通讯服务，涵盖催化剂、买卖评级、产品销售预测和财务分析 [1] 公司分析 - Kymera Therapeutics (NASDAQ: KYMR) 股价从2024年7月的46美元下跌至31美元，跌幅达33%，11月曾达到50美元以上的高点 [1] - 分析师在2024年7月给予该公司“买入”评级 [1] 分析师背景 - 分析师Edmund Ingham拥有超过5年的生物技术、医疗保健和制药行业研究经验 [1] - 分析师已汇编超过1,000家公司的详细报告 [1] - 分析师领导投资团体Haggerston BioHealth，提供行业分析和投资建议 [1]

Kymera Therapeutics, Inc. (KYMR) reported a first-quarter 2025 loss of 82 cents per share, narrower than the Zacks Consensus Estimate of a loss of 92 cents. In the year-ago quarter, Kymera reported a loss of 69 cents per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The year-over-year deterioration was due to higher R&D expenses.Collaboration revenues totaled $22.1 million, which beat the Zacks Consensus Estimate of $10 million.In the year-ago quarter, Kymera earned collabo ...

Kymera Therapeutics (KYMR) Q1 2025 Earnings Call May 09, 2025 10:00 AM ET Company Participants Justine Koenigsberg - VP - Investor RelationsNello Mainolfi - Founder, President & CEOJared Gollob - Chief Medical OfficerVeronica Campbell - Senior Director - ImmunologyYvonne Kumi - VP - Senior Quantitative AnalyticsSudan Loganathan - Managing DirectorNishant Jadav - Managing DirectorYifan Xu - Senior Associate - Biotechnology Equity Research Conference Call Participants Jeet Mukherjee - AnalystMarc Frahm - Biot ...

Kymera Therapeutics (KYMR) Q1 2025 Earnings Call May 09, 2025 10:00 AM ET Speaker0 Good morning, and welcome to Chimera's immunology innovation day, our virtual event to introduce our next immunology program, IRAV five. I'm Justine Koenigsberg, Chimera's head of investor relations. Please note that we are hosting today's event in lieu of our regularly scheduled quarterly update call. However, we have reported our results and filed our 10 Q this morning. For additional details on our Q1 results, please refer ...

Kymera Therapeutics, Inc. (KYMR) came out with a quarterly loss of $0.82 per share versus the Zacks Consensus Estimate of a loss of $0.92. This compares to loss of $0.69 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 10.87%. A quarter ago, it was expected that this company would post a loss of $0.76 per share when it actually produced a loss of $0.88, delivering a surprise of -15.79%.Over the last four quarters, the company h ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39460 KYMERA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) De ...

Exhibit 99.1 Kymera Therapeutics Announces First Quarter 2025 Financial Results and Provides a Business Update Completed KT-621 (STAT6) SAD/MAD Phase 1 healthy volunteer trial with data to be reported in June 2025 First patient dosed in KT-621 (STAT6) BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) with data expected in 4Q25 KT-579 (IRF5) new oral immunology degrader program, with broad clinical potential in rheumatic and other autoimmune diseases, expected to enter Phase 1 clinical tria ...

IRF5 program strengthens Kymera’s oral immunology pipeline with a complementary mechanism to expand into rheumatic and other autoimmune diseases with a potential best-in-class oral drug IRF5, a historically undrugged transcription factor and master regulator of immunity, has strong genetic and clinical pathway validation across multiple diseases including RA, SLE, IBD and others KT-579, a potent, selective, oral degrader of IRF5 with an excellent profile in preclinical safety studies, has demonstrated activ ...