Etigilimab

Evid AI Decider AI for ScienceAI制药决策智能AI制药赛道狂飙至145亿美元但产业链最关键的决策层，仍是空白 Evid AI Decider —— AI驱动的药物研发策略量化评估平台 2024年，全球AI制药市场规模达到22.8亿美元。预计到2031年，这一数字将飙升至145亿美元，年复合增长率高达30.7%。头部药企中超过60%已启动或正在建设AI辅助药物发现平台。 全球AI制药市场规模趋势：2024-2031年 但一个吊诡的事实是： AI制药的"工具层"已经卷成红海——分子生成、靶点预测、动力学模拟，玩家众多。 帮助药企判断"该往哪个方向投入资源、什么时候该止损"的决策层——几乎是一片空白。 2024年全球制药研发投入超过2000亿美元，但从临床I期到获批的成功率已跌至不足7%。每15个进入临床的候选药物，超过14个最终失败。问题在于：这些失败中约90%在理论上可被早期预测——如果决策者在立项之初就能获得足够系统、足够全面的评估。 这不是数据不够多，而是缺少一个能把海量多模态数据转化为"可执行决策边界"的引擎。AI制药产业链：上游和下游都在卷，中间缺了一座桥 AI制药产业链全景与EviDAI Decider卡位 AI制药产业链可以清晰划分为四层： •上游数据层：基因组学、蛋白质组学、临床数据、文献知识——数据爆炸，但未经整合 •中游工具层：靶点发现、分子生成、分子动力学模拟——工具百花齐放，但各自为政 •下游决策层：管线优先级排序、立项评估、资源分配、止损判断——这正是Evid AI Decider的卡位 •终端产出层：IND申报、临床推进、商业化 Evid AI Decider不生成新分子，不替代科学家的判断。它的核心定位是"药物研发决策者的量化参谋"——在分子生成上游和下游之间，填补从"信息"到"决策"的空白地带。Evid AI Decider：AI驱动的药物研发策略量化评估平台 "Stop guessing. Start deciding." Decider是Evid AI循证基座模型在制药决策场景的产品化落地。它融合多模态数据——涵盖遗传学、药理学、临床历史和文献证据——将异构信息归一化为统一评分，输出可直接用于研发决策的量化边界。 它的输出不是"信息"，而是"可执行的决策边界"——包括核心假说、验证实验方案、阳性对照，以及最关键的失败标准。四大核心能力：为什么Decider是决策层的唯一玩家 能力一：多模态数据融合引擎 Decider将遗传学证据、细胞系依赖性数据、临床试验记录、文献知识、药物特征及机制推理等多模态数据进行归一化、加权、融合，输出统一的量化评分。任何一个维度的强信号都会被捕捉，多维度共同指向时权重叠加放大。 能力二：时间制度分析（Temporal Regime） Evid AI Decider 时间制度分析：五种制度类型与候选分布 传统评估是静态的：这个靶点有文献支持吗？有药物在研吗？ Decider问的是动态问题：证据是在加速积累还是在降温？竞争格局是拥挤还是稀疏？这个方向处于生命周期的哪个阶段？ Decider定义了五种制度类型，每个候选被自动映射到对应的制度坐标： •甜区证据快速积累，竞争尚未拥挤——11个候选，立即推进 •新兴动量初显，路径待明——1个候选，密切监测 •空白推测区高度创新，证据稀缺——7个候选，远期期权 •拥挤前沿证据充分，竞争激烈——1个候选，差异化切入 •已确立机制验证，专利壁垒——4个候选，红海谨慎 两个在传统评估中得分相同的靶点，在Decider的时间制度中可能被分配到完全不同的层级。这种区分，正是研发资源错配和正确配置之间的分水岭。 能力三：决策边界生成器——从"知道"到"行动" 案例：Miransertib评估中的失败标准 "在≥3/4的耐药模型中，若联合治疗的肿瘤生长抑制率相对于曲妥珠单抗单药的优势低于30%，或无法在耐受剂量下将p-AKT(S473)抑制70%以上，则放弃该方向。" 把"这个药可能有用"的模糊判断，转化为"做实验、看数据、达到或没达到阈值"的可执行决策规则。 能力四：机制链推理与隐性关联发现 Decider不仅查询"A和B之间有没有已知关系"，还通过知识图谱发现"A→X→Y→B"这种间接机制链，从多篇独立文献的分散证据中推导出作者未意识到的组合机会。 实际案例：Decider在评估PD-L1×CD16a BiKE和Etigilimab时，发现BiKE激活NK细胞后会导致TIGIT上调和CD155上调，恰好为Etigilimab创造了作用窗口。由此生成了"BiKE启动→Etigilimab序贯"的组合策略（Fitness 0.68），该组合在任何公开数据库中均无现成记录。实战验证：乳腺癌24个候选，数小时完成传统数月的评估 为验证EviDAI Decider在真实世界中的应用价值，我们选择了乳腺癌（HER2阳性、三阴性、ER阳性三个主要亚型）作为验证场景，共评估24个精英候选方案，涵盖重定位、新模态和组合策略三种类型。 Evid AI Decider 乳腺癌24个候选药物Fitness评分与制度分布 发现一：自动识别已失败的"死胡同" Decider自动识别出4个已因安全性或无效性终止开发的项目——Rilotumumab（胃癌III期增加死亡风险）、Onvatilimab（I期CRS毒性终止）、Magrolimab（MDS/AML III期无效）——将其标记为"建议放弃"，避免资源浪费。 发现二：发现隐性组合机会 机制链推理引擎发现BiKE→Etigilimab顺序联合策略，在任何公开数据库中均无现成记录。这正是Decider"稀疏证据推理"能力的体现——从分散证据中推导出未意识到的机制链关系。 发现三：量化优先级，从24个候选药物 Top 5 排名 候选药物 疾病领域 Fitness 制度 状态 1 CRBN共价PROTAC（Y537S） ER+1.00甜区 概念阶段 2 Cys530共价PROTAC（双突变） ER+1.00甜区 概念阶段 3 Cys530共价PROTAC（组合版） ER+1.00甜区 概念阶段 4 Miransertib（ARQ 092） HER2+1.00甜区 活跃（Phase 2） 5 PI3Kα PROTAC降解剂 HER2+1.00甜区 概念阶段 Evid AI Decider在1小时内完成了24个候选的系统评估和优先级排序——传统方式需要数周至数月。 传统模式 vs Evid AI Decider模式：效率提升50倍以上竞争格局：Decider独占"高整合+高决策"象限 AI制药竞争格局：数据整合度 vs 决策输出深度 业务类型 代表工具 核心功能 Decider的差异化 数据库平台 OpenTargets DepMap 提供原始数据 不做数据存储，做数据融合与判断 文献挖掘工具 IBM Watson BenchSci 发现文献关联 不止找关联，还做推理和决策输出 管线跟踪工具 Cortellis Pharmaprojects 追踪谁在做什么 做前瞻性评估，而非向后看 AI分子生成 Exscientia Insilico 设计新分子 不设计分子，评估什么方向值得设计 专家委员会 内部SAB 人类经验判断 提供系统化、可重复的量化框架 Evid AI Decider的独特定位在于：它不与任何上述工具直接竞争，而是填补了从"信息"到"决策"之间的空白地带——在AI制药产业链中，这是唯一一个同时满足"高数据整合度"和"高决策输出深度"的象限。 AI制药的决策层，正在等待第一个定义者 Evid AI Decider —— AI驱动的药物研发策略量化评估平台在AI4S的浪潮中，决策智能是比分子生成更稀缺的底层能力了解更多 · 预约产品演示 本文数据基于公开资料整理，仅供参考，不构成投资建议

LONDON, May 12, 2026 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced financial results for the first quarter ended March 31, 2026, and provided an update on recent corporate developments. “Based on extensive analysis of data across the two global Phase 3 studies of setrusumab in osteogenesis imperfecta in collaboration with our partner Ultragenyx, we believe there is basis to engage with the regulatory agencies to determine if there is a path forward in pediatric patients. These interactions have been initiated, and we plan to provide updates once we have some definitive feedback. We continue to believe that setrusumab has the potential to provide meaningful benefit for people living with OI, a condition with no FDA or EMA approved therapies,” said Denise Scots-Knight, Chief Executive Officer of Mereo. “We are engaged with potential partners for alvelestat in AATD-LD and believe alvelestat can quickly enter Phase 3 development following closing of a partnership transaction. Our other partnered program, vantictumab, is continuing to move forward with āshibio, who plan to initiate a Phase 2 trial in osteopetrosis in the second half of 2026. We continue to expect that our cash position, which totaled $36.2 million as of March 31, will provide runway into mid-2027, through several key inflection points expected during the remainder of this year.” Recent Corporate Developments and Anticipated Milestones Setrusumab (UX143) Further analyses of the data from the Orbit and Cosmic Phase 3 studies, including patient subgroups, have been completed. While neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic), both studies achieved high statistical significance against the key secondary endpoint of improvement in bone mineral density versus control as well as reductions in vertebral fractures and improvements in patient reported outcomes (PROs) associated with disease severity, pain / discomfort and daily activities, with these PRO improvements achieving statistical significance in the Orbit study. The safety pro setrusumab was consistent with that observed in prior studies. Based on the Phase 3 data analysis from both global Phase 3 studies and the safety pro setrusumab, Mereo and its partner Ultragenyx believe there is a basis to engage regulatory agencies to determine if there is a path forward for setrusumab in pediatric patients. These interactions have been initiated. Alvelestat (MPH-966) Mereo is actively engaged in discussions with potential partners for the Phase 3 development and commercialization of alvelestat. Based on previous discussions with the FDA and EMA, Mereo anticipates a single Phase 3 trial enrolling approximately 220 early- and late-stage AATD-LD patients evaluating alvelestat over an 18-month treatment period will support regulatory submissions in both the U.S. and Europe. The primary efficacy endpoint for potential U.S. approval will be the St. George’s Respiratory Questionnaire (SGRQ) Total Score, with lung density measured by CT scan serving as the primary endpoint for potential European regulatory approval. These are independent primary endpoints. The Company believes initiation of the Phase 3 study could happen within 6 months of closing a potential partnership transaction. Vantictumab (OMP18R5) The Company’s development partner for vantictumab, āshibio, Inc., is continuing to advance toward initiation of a Phase 2 clinical trial in autosomal dominant osteopetrosis Type 2 (ADO2), which is expected to commence in the second half of 2026. āshibio is responsible for funding the global clinical program and holds the right to commercialize vantictumab outside of Europe, where Mereo has retained commercial rights. First Quarter 2026 Financial Results Total research and development (“R&D”) expenses increased by $0.8 million, from $3.9 million in the first quarter of 2025 to $4.7 million in the first quarter of 2026. The increase was primarily due to increases of $1.8 million in R&D expenses for setrusumab, partially offset by reductions of $0.9 million in R&D expenses for alvelestat. The increase in program expenses for setrusumab was primarily driven by recognition of a payable for our share of certain costs related to the cancellation of manufacturing slots by our partner, Ultragenyx, partially offset by reductions of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the first quarter of 2026. The decrease in program expenses for alvelestat was primarily due to completion of activities undertaken in preparation for the potential Phase 3 study in the first quarter of 2025. General and administrative expenses decreased by $3.3 million, from $7.3 million in the first quarter of 2025 to $4.0 million in the first quarter of 2026. The decrease was primarily due to the recognition of a $1.9 million reduction in expenses in the first quarter of 2026 for amounts received from our depository to reimburse certain expenses incurred by us in respect of our ADR program, and a reduction of approximately $1.4 million driven by delays to investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, if approved, and other realized cost savings. Net loss for the first quarter of 2026 was $6.7 million, compared to $12.9 million for the first quarter of 2025, primarily reflecting an operating loss of $8.8 million and foreign currency transaction gain of $1.6 million. As of March 31, 2026, the Company had cash and cash equivalents of $36.2 million, compared to $41.0 million as of December 31, 2025. The Company’s guidance remains unchanged, and it continues to expect, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses, and capital expenditure requirements into mid-2027. This guidance does not include any potential payments associated with business development activity around any of the Company’s programs. Total ordinary shares issued as of March 31, 2026 were 798,078,829. Total ADS equivalents as of March 31, 2026 were 159,615,765, with each ADS representing five ordinary shares of the Company.  About Mereo BioPharma Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The Company has three rare disease product candidates: setrusumab for the treatment of osteogenesis imperfecta (OI); alvelestat for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD); and vantictumab for the treatment of autosomal dominant osteopetrosis type 2 (ADO2). The Company and its partner for setrusumab, Ultragenyx Pharmaceutical Inc., have reported top-line results from the Phase 3 portion of a pivotal Phase 2/3 study in pediatrics and young adults (5 to 25 years old) and in the Phase 3 study in pediatric patients (2 to <7 years old) for setrusumab in OI. The partnership with Ultragenyx includes potential additional milestone payments of up to $245 million and royalties to Mereo on commercial sales in Ultragenyx territories. Mereo has retained EU and UK commercial rights and will pay Ultragenyx royalties on commercial sales in those territories. Setrusumab has received orphan designation for osteogenesis imperfecta from the European Commission (“EC”) and the FDA, PRIME designation from the EMA, and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which, if successful, could enable full approval in both the U.S. and Europe. The Company’s partner for vantictumab, āshibio, Inc., is funding the global development program and Mereo has retained EU and UK commercial rights. Mereo has also entered into an exclusive global license agreement with ReproNovo SA, a reproductive medicine company, for the development and commercialization of leflutrozole, a non-steroidal aromatase inhibitor for the treatment of infertility in men with low testosterone. In addition, Mereo has two oncology product candidates, etigilimab, an anti-TIGIT; and navicixizumab for the potential treatment of late-line ovarian cancer. Navicixizumab has been partnered with Feng Biosciences, Inc. in a global licensing agreement that includes milestone payments and royalties. Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact contained herein are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements reflect our current expectations, beliefs and assumptions concerning future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Risks and uncertainties include, among other things, the uncertainties inherent in the clinical development process; the Company’s reliance on third parties to conduct and provide funding for its clinical trials; the sufficiency of existing cash to fund operations and/or the inability to raise additional funding on favorable terms or at all; the uncertainty inherent in regulatory review processes, including varying interpretations and analyses of data from clinical trials; the Company’s dependence on enrollment of patients in its clinical trials; potentially smaller than anticipated market opportunities for the Company's product candidates; the Company’s dependence on its key executives; and the Company’s ability to maintain compliance with Nasdaq continued listing requirements. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company’s business, including those described in the “Risk Factors” section of its Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. Forward-looking statements are often identified by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “estimate,” “outlook,” “will,” “continue” and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company’s current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates. The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of our forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law. Mereo BioPharma Contacts: Mereo +44 (0)333 023 7300 Denise Scots-Knight, Chief Executive Officer Christine Fox, Chief Financial Officer Burns McClellan (Investor Relations Adviser to Mereo) +01 646 930 4406 Lee Roth Investors investors@mereobiopharma.com MEREO BIOPHARMA GROUP PLC CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited) March 31, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 36,223 $ 40,992 Prepaid expenses and other current assets 2,249 2,531 Research and development incentives receivables 1,562 1,497 Total current assets 40,034 45,020 Property and equipment, net 91 137 Operating lease right-of-use assets, net 108 244 Intangible assets, net 381 516 Total assets $ 40,614 $ 45,917 Liabilities Current liabilities: Accounts payable $ 3,226 $ 1,333 Accrued expenses 2,046 2,026 Operating lease liabilities – current — 202 Other current liabilities 905 741 Total current liabilities 6,177 4,302 Warrant liabilities – non-current 21 38 Other non-current liabilities 362 661 Total liabilities $ 6,560 $ 5,001 Shareholders’ Equity Ordinary shares, par value £0.003 per share; 798,078,829 shares issued at March 31, 2026 (December 31, 2025: 795,658,504) $ 3,145 $ 3,135 Additional paid-in capital 551,018 549,622 Accumulated deficit (507,538 ) (501,018 ) Accumulated other comprehensive loss (12,571 ) (10,823 ) Total shareholders’ equity 34,054 40,916 Total liabilities and shareholders’ equity $ 40,614 $ 45,917 MEREO BIOPHARMA GROUP PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) Three Months Ended March 31, 2026 2025 Operating expenses Research and development $ (4,747 ) $ (3,930 ) General and administrative (4,019 ) (7,272 ) Loss from operations (8,766 ) (11,202 ) Other income/(expenses) Interest income 327 659 Interest expense (20 ) (180 ) Changes in the fair value of warrants 17 416 Foreign currency transaction gain/(loss), net 1,628 (2,765 ) Benefit from research and development tax credit 95 185 Net loss before income tax (6,719 ) (12,887 ) Income tax benefit — — Net loss $ (6,719 ) $ (12,887 ) Loss per share – basic and diluted $ (0.01 ) $ (0.02 ) Weighted average shares outstanding – basic and diluted 801,805,570 784,279,387 Net loss $ (6,719 ) $ (12,887 ) Other comprehensive (loss)/income – Foreign currency translation adjustments, net of tax (1,748 ) 3,559 Total comprehensive loss $ (8,467 ) $ (9,328 )