Palupiprant

Enrollment ongoing in both QD and QW arms of global Phase I trial of pan-RAS(ON) inhibitor AN9025 First regulatory approval obtained for Phase I trial of pan-RAS(ON) ADC AN4035 Two leading medical oncologists appointed to Scientific Advisory Board SINGAPORE and NORTH BRUNSWICK, N.J., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced its business highlights and its first half financial results for the period ended June 30, 2026. “We continue to execute well across our pipeline, with initial clinical data on track for both of our pan-RAS(ON) inhibitor-based assets in 2027,” said Yang Lu, CEO and Chairman of Adlai Nortye. “In alignment with our goal of rapidly bringing a solution to cancer patients in the U.S. and globally, we are advancing our globalization strategy by expanding our clinical development, strategic, and operational capabilities in the United States and Singapore. This expansion will help to accelerate our clinical pipeline progress and strengthen our clinical operations to support our RAS program development. We believe these efforts will support the efficient global development of our pipeline and position the Company for long-term growth.” Research & Development (R&D) Highlights AN9025 AN9025, an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, continues to be evaluated in a global Phase I clinical trial of patients with advanced or metastatic solid tumors harboring RAS mutations. In February 2026, the first patient was dosed in the once-daily (QD) arm in the U.S. In July 2026, the first patient was dosed in the intermittent once-weekly (QW) arm in the U.S. Both the QD and QW dosing arms are enrolling concurrently in the U.S. and China. Additional clinical trial sites in the U.S. will be activated in second half of 2026, in preparation for expansion cohorts. The Company remains on track to share initial Phase Ia dose escalation data in the first half of 2027 from the QD arm, with a potential early look at the QW arm. AN4035 AN4035 is a first-in-class RAS-inhibitor antibody drug conjugate (ADC) targeting CEACAM5, with a highly potent pan-RAS(ON) inhibitor payload. In July 2026, the Company received Human Research Ethics Committee (HREC) approval in Australia for the Phase I clinical trial of AN4035 as monotherapy and in combination with cetuximab, in patients with CEACAM5-enriched, RAS-addicted solid tumors. Investigational New Drug (IND) submissions to the U.S. FDA and China NMPA are expected to follow. The Company is on track to dose the first patient with AN4035 in the second half of 2026, and initial clinical data is expected to be available in the second half of 2027. AN8025 AN8025 is a next-generation tri-specific antibody fusion protein derived from an approved αPD-L1 antibody and fused with functionally optimized CD86 variant and LAG3 variant. The global Phase I clinical study of AN8025 is currently ongoing in Australia and China. The Company remains on track to complete dose escalation by the end of 2026. AN0025 AN0025 is a small molecule EP4 antagonist designed to modulate the tumor microenvironment. The randomized Phase II ARTEMIS (Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery) study of preoperative AN0025 and chemoradiotherapy combination in rectal cancer has completed enrollment and patient follow-up is ongoing. The futility analysis of this Phase II study was successfully passed in March 2026, and the topline results are expected in the first half of 2027. AN4005 AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction. Despite encouraging preliminary results of favorable safety and tolerability in patients with advanced tumors, and preliminary efficacy in a tumor type known to respond to anti-PD-(L)1 therapy, moving forward as part of our strategic pipeline prioritization, we will de-prioritize the development of AN4005 as a monotherapy and remain open for collaboration to explore its potential as a combination partner. A clinical update from the ongoing expansion cohorts is expected to be presented at the 2026 Society for Immunotherapy of Cancer (SITC) meeting. Corporate Highlights In February 2026, the Company completed an oversubscribed private placement equity financing, raising $140 million, before deducting placement agent fees and other private placement expenses. In April 2026, the Company completed an oversubscribed private placement equity financing, raising $150 million, before deducting placement agent fees and other expenses. The Company recently expanded its Scientific Advisory Board with the appointment of two leading medical oncologists, Dr. David Hong of MD Anderson Cancer Center, and Dr. Piro Lito of Memorial Sloan Kettering Cancer Center. Key Upcoming Milestones AN9025: Initial Phase Ia clinical data from the QD arm, and possible early look at QW arm, are expected in 1H27 AN4035: Dosing of first patient in global Phase I trial is expected in 2H26, with initial clinical data in 2H27 AN8025: Phase I dose escalation completion expected by YE 2026 First Half Unaudited Financial Results The consolidated financial statements of the Company are prepared in accordance with IFRS as issued by the International Accounting Standards Board (IASB). The consolidated financial statements are presented in US dollars, the Company’s functional and presentation currency. As of June 30, 2026, cash and cash equivalents, together with short-term investments at amortized cost, amounted to US$231.9 million, compared with US$8.1 million as of December 31, 2025. Net cash used in operating activities was US$15.4 million for the six months ended June 30, 2026, compared with US$15.1 million for the six months ended June 30, 2025. Revenue increased to US$13.1 million for the six months ended June 30, 2026, from nil for the six months ended June 30, 2025, and was entirely attributable to revenue recognized under the Company’s exclusive license agreement with Jiangsu Aosaikang Pharmaceutical Co., Ltd. relating to AN9025, primarily in connection with upfront payments and development milestone achievements. Research and development expenses decreased by 4% from US$15.2 million for the six months ended June 30, 2025 to US$14.6 million for the six months ended June 30, 2026, primarily due to lower preclinical development costs, as most of the Company’s major research and development programs remained in early-stage development and had not yet advanced into later-stage clinical trials. General and administrative expenses increased by 43.1% from US$4.1 million for the six months ended June 30, 2025 to US$5.8 million for the six months ended June 30, 2026. The increase was primarily attributable to higher share-based compensation expense associated with the vesting of certain stock options. Other gains and expenses, net, decreased by 37.1% from US$1.5 million for the six months ended June 30, 2025 to US$0.9 million for the six months ended June 30, 2026, primarily due to a reduction in government grants recognized during the period. For the reasons described above, the Company’s net loss decreased by 70.9% to US$5.3 million for the six months ended June 30, 2026, from US$18.3 million for the six months ended June 30, 2025. About Adlai Nortye Adlai Nortye is a global clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The global infrastructure supports the efficient execution of our robust pipeline of drug candidates covering two key therapeutic areas: 1) Precision RAS pathway targeted therapies: including the oral pan-RAS(ON) inhibitor AN9025, and the CEACAM5-targeting ADC AN4035 engineered from the Company’s proprietary RASiCA™ (RAS Inhibitor Conjugated Antibody) platform, which efficiently delivers a potent pan-RAS(ON) inhibitor to the tumor site. 2) Next-generation PD-1/L1 pathway modulating immunotherapies: including AN8025, a multi-functional fusion protein that simultaneously modulates T cells and antigen-presenting cells. Forward-Looking Statement This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Factors that could cause the Company’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this announcement and in the attachments is as of the date of this announcement, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law. Company contact: Investor Relations Email: ir@adlainortye.com ADLAI NORTYE LTD. UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (All amounts in thousands, except share and per share data, or as otherwise noted) Six Months Ended June 30, 2025 June 30, 2026 $’000 $’000 REVENUE — 13,056 Other operating income, net 140 1,624 Administrative expenses (4,066 ) (5,817 ) Research and development expenses (15,248 ) (14,632 ) Total operating loss (19,174 ) (5,769 ) Other gains and expenses, net 1,461 919 Investment income 98 2 Share of loss of investments accounted for using the equity method (4 ) (43 ) Finance costs (716 ) (445 ) LOSS BEFORE TAX (18,335 ) (5,336 ) Income tax expense — — LOSS FOR THE PERIOD (18,335 ) (5,336 ) Attributable to: Ordinary Equity Holders of the Parent (18,335 ) (5,336 ) OTHER COMPREHENSIVE LOSS Exchange differences on translation of the financial statements of subsidiaries 82 1 Other comprehensive loss for the period, net of tax 82 1 TOTAL COMPREHENSIVE LOSS FOR THE PERIOD (18,253 ) (5,335 ) Attributable to: Ordinary Equity Holders of the Parent (18,253 ) (5,335 ) LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT Basic and diluted Loss for the period ($ per share) (0.19 ) (0.04 ) Weighted average common shares outstanding 95,862,790 143,294,754 ADLAI NORTYE LTD. UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS (All amounts in thousands, except share and per share data, or as otherwise noted) Six Months Ended June 30, 2025 2026 $’000 $’000 Net cash flows used in operating activities (15,121 ) (15,354 ) Net cash flows used in investing activities (18,181 ) (83,744 ) Net cash flows from financing activities 16,584 223,141 NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS (16,718 ) 124,043 Cash and cash equivalents at beginning of the period 60,902 8,056 Effect of foreign exchange rate changes, net 34 491 CASH AND CASH EQUIVALENTS AT END OF THE PERIOD 44,218 132,590 ADLAI NORTYE LTD. UNAUDITED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (All amounts in thousands, except share and per share data, or as otherwise noted) As of December 31, 2025 June 30, 2026 $’000 $’000 ASSETS Current assets Cash and cash equivalents 8,056 132,590 Restricted cash 15,730 80 Financial assets at FVTPL — 931 Short-term investments at amortized cost — 99,296 Trade receivables — 264 Prepayments, other receivables and other assets 3,091 7,702 Other receivables -related party 15 16 Total current assets 26,892 240,879 Non-current assets Property, plant and equipment 1,219 1,105 Right-of-use assets 1,801 1,749 Other intangible assets 19 8 Other receivables and other assets 253 280 Long-term equity investments 4,249 4,341 Total non-current assets 7,541 7,483 Total assets 34,433 248,362 LIABILITIES Current liabilities Trade payables 12,638 4,610 Other payables and accruals 3,741 2,223 Interest-bearing bank borrowings 24,582 17,619 Lease liabilities 667 772 Total current liabilities 41,628 25,224 Non-current liabilities Long-term borrowings — 7,341 Lease liabilities 1,127 969 Total non-current liabilities 1,127 8,310 Total liabilities 42,755 33,534 SHAREHOLDERS’ EQUITY Class A Ordinary shares (par value of $0.0001 per share; 103,010,803 shares outstanding as of December 31, 2025; and 176,203,813 shares outstanding as of June 30, 2026) 10 17 Class B Ordinary shares (par value of $0.0001 per share; 16,990,000 shares outstanding as of December 31, 2025 and June 30, 2026) 2 2 Share premium 439,266 670,208 Share based payments reserve 21,592 19,128 Exchange fluctuation reserve (4,346 ) (4,345 ) Accumulated deficit (464,846 ) (470,182 ) Total shareholders’ equity (8,322 ) 214,828 Total liabilities and shareholders’ equity 34,433 248,362 ADLAI NORTYE LTD. UNAUDITED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (All amounts in thousands, except share and per share data, or as otherwise noted) Attributable to owners of the parent Ordinary Shares Additional paid-in capital Share option reserve Exchange fluctuation reserve Accumulated losses Total deficits $’000 $’000 $’000 $’000 $’000 $’000 At January 1, 2025 11 439,016 20,311 (4,535 ) (429,318 ) 25,485 Loss for the period — — — — (18,335 ) (18,335 ) Vesting of restricted shares — 157 (157 ) — — — Other comprehensive income for the period: Exchange differences on translation of the financial statements of subsidiaries — — — 82 — 82 Share-based compensation — — 689 — — 689 At June 30, 2025 11 439,173 20,843 (4,453 ) (447,653 ) 7,921 At January 1, 2026 12 439,266 21,592 (4,346 ) (464,846 ) (8,322 ) Loss for the period — — — — (5,336 ) (5,336 ) Issuance of ordinary shares 7 224,430 — — — 224,437 Exercise of share options — 5,090 (2,786 ) — — 2,304 Vesting of restricted shares — 1,422 (1,422 ) — — — Other comprehensive income for the period: Exchange differences on translation of the financial statements of subsidiaries — — — 1 — 1 Share-based compensation — — 1,744 — — 1,744 At June 30, 2026 19 670,208 19,128 (4,345 ) (470,182 ) 214,828

一个多极反转的故事正在纳斯达克上演。 2026年1月2日，一家名为阿诺医药（Adlai Nortye，股票代码：ANL）的临床阶段生物技术公司，其市值停留在约0.52亿美元的低谷。 不到半年后——2026年6月3日，这家公司的市值达到了7.46亿美元。 阿诺医药2026年以来股价走势 区间涨幅高达逾1300%。 更具戏剧性的是，这场市值狂飙发生在一场足以致命的“灾难”之后：2025年5月30日，公司的旗舰管线——评估Buparlisib（AN2025）治疗头颈癌的全球III期BURAN试验未达到改善总生存期的主要终点，公司随即宣布终止该产品开发。 一家临床失败、陷入“绝境”的Biotech，如何完成了这场令人瞠目的资本逆袭？ 生死时刻：BURAN失败 2025年5月30日，是阿诺医药历史上糟糕的一天。 公司正式公布III期BURAN试验的顶线结果：Buparlisib联合紫杉醇对比紫杉醇单药治疗复发或转移性头颈鳞状细胞癌，未达到改善总生存期这一主要终点。 BURAN是一项随机（2:1）、开放标签的全球III期研究，共入组487名患者。 “我们对BURAN III期研究的结果感到失望，”公司CEO兼董事长路杨坦言，“基于这些结果，我们决定终止Buparlisib的进一步开发。” 这不仅是失望，更是一场生存危机。 Buparlisib是阿诺医药从诺华引进的核心管线，也是公司最接近商业化的项目。项目终止后，市场目光不得不重新聚焦于公司管线中处于临床早中期的其他资产，如处于临床I期的AN9025、AN8025、AN4005以及临床II期的AN0025。 市场迅速作出反应。 H.C. Wainwright分析师Joseph Pantginis在2025年6月2日发布报告，将阿诺医药的评级从“买入”下调至“中性”，并取消此前9美元的目标价。他称这次试验失败“令人失望”且“不幸”，并直言“鉴于阿诺剩余管线尚处于早期阶段”，只能等待未来的临床进展再作判断。 对此，路杨宣布了两项核心自救措施。 一是“优化人力资源结构并推进薪酬调整”，即裁员节流；二是“将资源和精力重新聚焦于AN8025和AN9025的推进”。 “裁员节流”和“聚焦”不是轻描淡写的漂亮话，而是一场伴随着剧痛的财务收缩。 阿诺医药的2025年财报就提到：截至2025年12月31日，公司账面现金及现金等价物已暴跌至805.6万美元，而2024年底还有6090万美元，同时面临1473.6万美元的净流动负债缺口。 由于面临严重的流动性缺口，公司管理层在财报中坦承，现金流紧张的状况曾让公司的持续经营能力一度存在重大不确定性。 不过，财报也印证了管理层“刮骨疗毒”的决心。2025年，公司全年研发费用被硬生生压降26.9%，降至3283万美元；员工总数从去年的123人缩减到109人，美国基地的研发人员被大幅裁减。 最核心的变化体现在资金支出的结构上：随着AN2025项目此前已完成III期临床的患者入组，其相关的CRO服务费自然回落，从2024年的1857万美元顺势降至913万美元。 这一旧项目支出的自然缩减，客观上让阿诺医药在资金紧张的时刻，能够将宝贵的剩余资源向新一代核心管线进行挪移。 绝地求生：一场关键授权与重磅融资 真正的转折从2025年底开始。 第一块多米诺骨牌来自大中华区。 2025年12月29日，就在股价最低迷的时刻，阿诺医药宣布与江苏奥赛康药业签署AN9025在中国大陆、香港和澳门的独家授权协议。 奥赛康药业获得AN9025在上述区域的独家开发、生产和商业化权利，阿诺医药则保留上述区域以外的全球权益。 这笔交易的财务条款颇具分量：总对价最高可达16亿元人民币（约2.3亿美元），其中包括超过2000万美元的首付款和近期里程碑付款，另加高个位数至百分之十几中段的阶梯式销售分成。 在资金极度紧张的时间节点，这一授权交易不仅带来了宝贵的现金注入，更向市场释放了一个信号——AN9025是有价值、有人愿意买单的资产。 另一转折点在2026年2月3日引爆。 在授权协议签署仅一个多月后，阿诺医药宣布达成一项预计总额约1.4亿美元的PIPE（上市公司私募股权融资）协议。 此次融资计划以每股A类普通股2.1667美元（相当于每股ADS 6.50美元）的价格发行股份。 根据财报披露，截至财报发布日，公司已从该笔融资中实际收到约8500万美元的资金注入，Cormorant等知名机构现身其中。 多家专业机构在公司最低谷时的注资，向市场传递了极为强烈的信心。 市场反应立竿见影。融资消息公布当天，ANL股价大涨约23%。 华尔街的分析师们很快跟进。 2月13日，H.C. Wainwright将评级从“中性”上调至“买入”，给出16美元目标价。 3月20日，Leerink Partners以“跑赢大盘”评级启动覆盖。 4月20日，HC Wainwright将目标价进一步上调至20美元。 资本攻势并未止步。2026年4月16日，阿诺医药宣布以每股ADS 13.25美元的价格完成约1.5亿美元的追加PIPE融资，并获得超额认购。 新一批重磅投资者Soleus Capital、Perceptive Advisors、MPM BioImpact等加入，原有的Cormorant、Columbia Threadneedle等也继续跟投。 到此时，公司股价从年初至今回报率已达833%。 筹码来自哪里？RAS赛道的时代风口 资本为什么愿意砸钱？ 答案藏在阿诺医药切换跑道后的核心资产——AN9025身上。 AN9025是一款口服小分子泛RAS（ON）抑制剂，靶向在多种肿瘤类型中广泛存在的RAS突变。 RAS是癌症中最常见的突变基因家族之一，长期以来被视为“不可成药”靶点，然而近年来随着SHP2抑制剂、KRAS G12C抑制剂等突破性药物的出现，这一赛道已成为全球肿瘤药物研发的最热战场。 阿诺医药在这场竞赛中有两个独特定位。 首先，AN9025是一款pan-RAS（ON）抑制剂，即同时抑制多种RAS突变类型的活性构象，相比单一突变靶向药物具有更广泛的潜在适应症覆盖。其次，AN9025是口服小分子药物，相比注射类药物具有便利性优势。 临床前数据也相当亮眼：在胰腺癌、肺癌和结直肠腺癌等RAS突变小鼠肿瘤模型中，AN9025与同类基准药物相比展现出相当或更优的疗效。公司研发负责人谢毅钊博士称AN9025具备“同类最佳潜力”。 2026年2月12日，公司宣布AN9025全球I期临床试验首位美国患者已完成入组给药，这项多中心、开放标签研究将系统评估药物的安全性、耐受性和抗肿瘤活性。 至此，阿诺医药已经从一家“依赖License-in管线”的公司，悄然蜕变为主攻热门赛道、拥有自研核心资产的潜在明星。 与此同时，公司的另一条管线AN8025也不容忽视。 AN8025是一款三特异性抗体融合蛋白（αPD-L1 × CD86变体 × LAG3变体），旨在同时调节T细胞和抗原呈递细胞功能，代表了下一代免疫疗法的发展方向。 加上同类首创口服小分子PD-L1抑制剂AN4005和CEACAM5靶向的ADC管线AN4035，阿诺医药已建立起覆盖肿瘤免疫和RAS靶向两大方向的完整管线矩阵。 向死而生的启示 阿诺医药的故事颇具启示意义。 复盘这场逆转，最关键的节点或许是CEO路杨在BURAN失败公告中的那一句：“我们将重新聚焦资源”。 这句话看似平淡，却揭示了一家Biotech真正的生命力，不在于某一特定管线的成败，而在于企业能否在关键时刻做出果断的战略转向。 阿诺医药在BURAN失败后没有纠缠于沉没成本，而是在不到半年内果断完成三项核心动作： 一是将AN9025中国大陆及中国港澳地区权益以最高2.3亿美元对价授权给奥赛康，锁定早期现金流和外部信任； 二是通过签订约1.4亿美元的PIPE融资协议，补充了宝贵的资金弹药，引入了Cormorant等专业投资机构站台； 三是快速推进AN9025进入全球I期临床，将公司从“失败叙事”切换到“RAS叙事”，为下一步投资打开想象空间。 每一步都踩在生存的要害上。 当然，激进的重组叙事之后，真正的考验还在前方。 AN9025刚刚进入I期临床试验，距离验证疗效和商业化还有漫长道路。RAS赛道已很拥挤，Revolution Medicines和Erasca等先行者的管线在进度上领先数年。 即便今年以来市值已暴涨逾1300%，以公司目前的产品阶段和财务状况来看，仍然具有一定风险。 财报客观揭示了这种高风险属性：阿诺医药在2025年虽然确认了500万美元的收入，但这仅仅是因为过去某个客户授权期权终止而转化的“合同负债”，公司至今依然没有一分钱的真实产品销售收入。 但无论如何，阿诺医药已经为创新药企业上了一堂鲜活的“极限生存课”。 在这个三期临床失败常常意味着企业终结的时代，阿诺证明了：一家Biotech的真正护城河不是某个管线的成败，而是在被命运击倒后，有足够锐利的眼光和足够果决的行动力，在下一次机会出现时精准起身反击。 对于正在穿越资本寒冬和管线阵痛的中国创新药企业而言，运势逆转背后，指向的是一个朴素的生存法则——不要下牌桌，手里永远要有一张能翻盘的底牌。