Pevifoscorvir sodium

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the second quarter 2026. “Our team has continued to execute on our key strategic priorities to advance our pipeline this year,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “We strengthened our financial position through non-dilutive capital, including the $25M upfront payment related to the exclusive Greater China license for pevifoscorvir sodium. In addition, our partner Amoytop has advanced our potential best-in-class ASO for chronic HBV infection, bringing the program through IND approval in China, resulting in a $3M milestone payment. Pevifoscorvir sodium continues to make significant progress, highlighted by the completion of enrollment for the Phase 2 B-SUPREME study and the receipt of Breakthrough Designation in China for chronic HBV infection. As we look ahead to topline data from the B-SUPREME study which is expected in late Q3 next year, we remain confident that our differentiated pipeline has the potential to meaningfully reduce the burden of end-stage liver disease and liver cancer, the main goal of chronic HBV infection treatment.” Recent Business Progress Pipeline Updates ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection In addition to Fast Track Designation from the U.S. Food and Drug Administration, pevifoscorvir sodium was granted Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for chronic hepatitis B virus (HBV) infection. The Phase 2 B-SUPREME study (NCT06963710) has completed enrollment with 131 participants enrolled in the HBeAg+ cohort (Part 1a) and 114 participants enrolled in the HBeAg- cohort (Part 2a). Topline data for both the HBeAg+ and HBeAg- cohorts are expected in late Q3 2027. The Company entered into an exclusive license deal with Xiamen Amoytop Biotech Co., Ltd. (Amoytop) to develop and commercialize pevifoscorvir sodium in Greater China for chronic HBV infection. Aligos received the $25M upfront and is entitled to up to $420M USD in clinical, regulatory, and sales milestones with tiered, high single-digit royalties. According to a recently published paper by Papatheodoridis, et. al. (Journal of Hepatology, July 2026), despite >10 years of nucleos(t)ide analog therapy, patients with chronic HBV infection remain at risk for hepatocellular carcinoma. Chronic HBV infection remains a large unmet medical need with ~240 million patients worldwide and 1.2 million new infections each year according to the World Health Organization. ALG-170675: Potential best-in-class antisense oligonucleotide (ASO) for chronic hepatitis B virus (HBV) infection ALG-170675 is a next-generation ASO discovered as part of a research collaboration with Amoytop, who maintain rights in Greater China. Novel intellectual property has been filed for this candidate, which has shown improved RNase H mediated in vivo activity over GSK-836 (bepirovirsen) with similar hTLR8 agonist activity observed in vitro and in vivo. In addition, ALG-170675 utilizes novel monomers that could potentially reduce ASO toxicity and improve ASO liver to kidney ratios. Additionally, nonclinical studies have shown additive to synergistic effects when combined with a CAM-E. Our partner Amoytop received IND approval in China for ALG-170675, and is expected to advance the program into clinical studies with a Phase 1 SAD/MAD study in healthy volunteers, followed by multiple doses in participants with chronic HBV infection in China. Current costs for development in China are being funded by Amoytop, who maintain rights in Greater China. Amoytop’s receipt of IND approval in China for ALG-170675 triggered a $3M milestone payment to Aligos, which is expected to be received in Q3 2026. Under our agreement with Amoytop, Aligos retains ex-Greater China rights and all data generated by either partner can be used in their respective territories. Aligos has the potential to conduct a Phase 2 study in 2028, which may include combination therapy (e.g. pevifoscorvir sodium). Each party is responsible for their own development costs. Financial Results for the Three Months Ended June 30, 2026 Cash, cash equivalents and investments totaled $30.4 million as of June 30, 2026, compared with $77.8 million as of December 31, 2025. This excludes the $25M upfront payment received from Amoytop in July 2026. Our cash and cash equivalents are expected to provide sufficient funding of planned operations through the fourth quarter of 2026. Net loss for the three months ended June 30, 2026 was $1.5 million or basic and diluted net loss per common share of $(0.14), compared to net loss of $15.9 million or basic and diluted net loss per common share of $(1.53), for the three months ended June 30, 2025. Research and development (R&D) expenses for the three months ended June 30, 2026 were $24.1 million, compared with $14.0 million for the same period of 2025. The increase was primarily due to an increase in third-party expenses for the pevifoscorvir sodium Phase 2 clinical trial. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2026 was $0.7 million, compared with $0.6 million for the same period of 2025. General and administrative (G&A) expenses was flat at $5.6 million each for the three months ended June 30, 2026 and June 30, 2025. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2026 was $0.7 million, compared with $0.5 million for the same period of 2025. Interest and other income, net, was income of $0.2 million for the three months ended June 30, 2026 compared with income of $1.2 million for the same period in 2025. Change in fair value of 2023 common warrants for the three months ended June 30, 2026, was income of $3.0 million compared with income of $1.7 million for the same period of 2025. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus (HBV) infection. For more information, please visit or follow us on LinkedIn or X. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to the expected data releases and data presentations for the Company’s ASO program in HBV, and timing of data readouts for the pevifoscorvir sodium B-SUPREME study; potential success of the Company’s development programs, including timing of the Company’s anticipated ASO clinical trials; the potential for ALG-170675 to reduce ASO toxicity and improve ASO liver to kidney ratios; the potential additive to synergistic effects of ALG-170675 when combined with a CAM-E; statements about the Company’s plans to conduct a Phase 2 study on ALG-170675 in 2028, and whether it may include combination therapy (e.g. pevifoscorvir sodium); statements regarding potential financial milestones being met and future royalties being earned by Aligos under the Amoytop license, and regarding Amoytop’s success in developing the ASO and/or pevifoscorvir sodium in Greater China, including statements regarding timing and design of Amoytop’s anticipated clinical trials; and the company’s expectation that its cash, cash equivalents and investments provide sufficient funding of planned operations into the fourth quarter of 2026. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, reliance on collaborators to succeed in their development efforts and to comply with their contractual obligations, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission on August 6, 2026 and Aligos’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2026 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Investor Contact Jordyn Tarazi Vice President, Investor Relations & Corporate Communications +1 (650) 910-0427 jtarazi@aligos.com Aligos Therapeutics, Inc Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Revenue from customers $ - $ 965 $ 2,830 $ 1,276 Revenue from licensing agreements 27,778 - 27,778 - Operating expenses: Research and development 24,050 13,976 47,402 28,478 General and administrative 5,618 5,556 12,025 10,608 Total operating expenses 29,668 19,532 59,427 39,086 Loss from operations (1,890 ) (18,567 ) (28,819 ) (37,810 ) Interest and other income, net 221 1,207 1,032 2,087 Change in fair value of 2023 common warrants 2,976 1,682 6,371 63,176 Income (loss) before income tax 1,307 (15,678 ) (21,416 ) 27,453 Income tax provision (2,811 ) (185 ) (3,128 ) (228 ) Net (loss) income $ (1,504 ) $ (15,863 ) $ (24,544 ) $ 27,225 Net (loss) income per share, basic $ (0.14 ) $ (1.53 ) $ (2.36 ) $ 2.90 Net (loss) income per share, diluted $ (0.14 ) $ (1.53 ) $ (2.36 ) $ 2.90 Weighted-average shares of common stock, basic 10,430,808 10,351,120 10,416,964 9,385,167 Weighted-average shares of common stock, diluted 10,430,808 10,351,120 10,416,964 9,401,645 Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands) June 30, 2026 December 31, 2025 (Unaudited) (Audited) ( 1) Assets Current assets: Cash and cash equivalents $ 30,381 $ 18,303 Short-term investments - 59,541 Accounts receivable 27,778 - Other current assets 3,968 5,018 Total current assets 62,127 82,862 Other assets 4,200 5,671 Total assets $ 66,327 $ 88,533 Liabilities and Stockholders’ Equity Current liabilities $ 28,343 $ 21,233 Other liabilities, noncurrent 6,100 13,755 Total liabilities 34,443 34,988 Total stockholders’ equity 31,884 53,545 Total liabilities and stockholders’ equity $ 66,327 $ 88,533 _____________________________________________ (1) The condensed consolidated balance sheet as of December 31, 2025 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

2026年第二季度（4-6月）全球医药授权交易热度持续高企，国产创新药出海、跨国药企引进管线、国内产业双向授权、海外药企管线交易四大赛道同步放量。 本季度全面梳理 License Out（国产创新对外授权出海）、License In（国内引进海外资产）、国内企业间管线授权、海外药企全球资产交易四类合作案例，覆盖肿瘤、GLP-1代谢、自免肾病、神经、眼科、CGT、ADC、长效多肽等当下最热门研发赛道，多笔交易总里程碑金额突破10亿美元，最高单笔合作规模达152亿美元，重磅合作接连落地。 01 license out 交易概况 二季度国内创新药企共计达成38笔对外出海授权，诞生多笔行业里程碑式重磅大单：恒瑞医药牵手百时美施贵宝、信达生物携手辉瑞两大百亿级合作，另有时安生物、天境生物等企业交出超8亿美元合作订单，肿瘤、GLP-1代谢减重、疼痛、肾病、ADC、长效多肽是海外药企采购的核心赛道。 5月12日， 百时美施贵宝以总金额152亿美元拿下恒瑞 13 款创新资产 （ 涵盖肿瘤学、血液学及免疫学 ） ，首付款 达 6亿美元；5月29日 辉瑞斥资105亿美元引进信达生物 8 个 早期 管线 ，首付款6.5亿美元。这两笔合作接连刷新国内药企单项目对外授权的金额天花板，也折射出海外大型药企的采购偏好 ， 相较于单一早期靶点，具备完整多管线布局、差异化临床数据支撑的成熟资产更受青睐。 表1 license out授权交易事件 02 license in交易概况 二 本季度国内药企共落地11笔海外资产引进合作，交易标的以成熟小分子、单抗、专科特色药物为主，覆盖慢性乙肝、阿尔茨海默、血液病、肾病、帕金森、偏头痛等细分领域，单笔交易规模集中在3000万至4.45亿美元区间，中小生物科技企业、专科药企成为海外管线引进主力军。 不少企业瞄准老龄化、慢病刚需赛道布局： 特宝生物斥资4.45亿美元引进Aligos乙肝创新分子ALG-000184 ，切入慢性乙肝治愈黄金赛道； 复星医药花费2.4亿美元拿下AriBio阿尔茨海默病管线AR1001 ，首付款达8000万美元，精准布局国内老龄化带来的庞大 AD 用药市场； 云顶新耀出资3.4亿美元引进 Dimerix 肾病管线DMX-200 ，深耕肾病自免领域。除此之外，万乐药业、友华生技分别引进淋巴瘤、白血病靶向药物，小众专科赛道竞争压力更小，商业化落地确定性更强。 表2 license in授权交易事件 03 国内授权交易概况 二季度共落地16笔交易，覆盖肿瘤、自免、自身免疫、银屑病、心血管、中药创新等领域， 单笔交易金额跨度从300万美元至20.24亿美元，头部创新药企与传统转型药企之间资产双向流转频繁，产业内部资源整合加速。 本季度国内授权最大单笔交易出自 百济神州，企业斥资20.24亿美元从华辉安健购入PD-1/CTLA-4/VEGF-A三特异性化合物管线 ； 君实生物对外转让ADC平台技术，旗下银屑病单抗 JS005 被万邦医药以1.976亿美元引进；云顶新耀持续加码国内管线布局，先后从天广实、威凯尔收购自免、抗血栓核心品种。 石家庄四药连续多笔引进呼吸、降脂、眼科生物类似药；维健医药、金活医药等商业化平台企业，向创新公司引进创新品种，依托自身渠道实现快速落地； 中科院微生物所将四价登革热疫苗转让给君拓生物，打通实验室成果产业化通道 。 表3 国内授权许可交易事件 04 海外授权交易概况 放眼全球医药市场，二季度海外药企累计达成近85笔授权交易，单笔合作最高规模23亿美元。 罗氏收购 Nurix 针对 B 细胞恶性肿瘤的管线 ，实体瘤、神经退行疾病、基因治疗AAV载体、代谢、骨科等前沿赛道全面火热，跨国药企持续通过外部授权补齐自身管线短板，AI制药、蛋白降解、基因疗法成为全球资本重点布局方向 。 安斯泰来引进Dyno新 型 AAV衣壳布局肌肉疾病； Jazz 豪掷24.6亿美元拿下下一代TCE多抗开发平台 ，前沿生物技术平台估值持续走高。老龄化慢病赛道竞争白热化，礼来10亿美元引进阿尔茨海默管线、Madrigal出资10亿美元收购脂肪肝 RNA疗法，阿尔茨海默、非酒精性脂肪肝等慢病成为全球药企必争之地。吉利德分两笔收购癌症、三阴性乳腺癌管线；艾伯维14.5亿美元布局胰腺癌、结直肠癌小分子； Tolmar引进靶向放疗技术用于前列腺癌，各类全新治疗手段持续丰富全球肿瘤治疗管线 。 表4 海外授权许可交易事件 （ 部分 ） 05 小结 2026年第二季度全品类医药授权交易数据，直观印证国内生物医药产业完成关键转型：行业彻底摆脱早年“仿制药跟跑”的发展阶段，迈入源头创新、全球输出的全新周期。国产管线出海变现、海外成熟资产引进补短板、国内产业内部资源整合、全球前沿技术协同合作四大板块同步发力，BD商务拓展早已不再是创新药企可选项，而是支撑企业研发、扩张、持续生存的核心战略抓手 。 声明：本文仅作信息传递之目的，并不代表本平台观点。本文也不是治疗方案推荐，如需获得治疗方案指导， 请前往正规医院就诊。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间核实并处理。