Adds a potential blockbuster opportunity with gildeuretinol (ALK-001), a differentiated Phase 3 oral investigational medicine designed to target the underlying biology of Stargardt disease, one of the largest inherited retinal diseases with no FDA-approved therapy

增加了与gildeuretinol（ALK-001）相关的潜在重磅机会，这是一种处于第三阶段研究的口服实验性药物，旨在针对Stargardt病的根本生物学机制，而Stargardt病是最大的遗传性视网膜疾病之一，目前尚无FDA批准的治疗方法。

400+ individuals treated to date, with encouraging positive structural and functional clinical findings; and over seven years of long-term tolerability data

迄今已治疗400多名患者，临床结构性和功能性检查结果均呈现令人鼓舞的积极趋势；并拥有超过七年的长期耐受性数据

Top-line Phase 3 NORTHSTAR data expected in the second half of 2029; Has received Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations

预计2029年下半年公布NORTHSTAR III期临床试验的顶线数据；已获得突破性疗法、孤儿药及罕见儿科疾病认定

Together with IRX-101, this acquisition is expected to expand Tarsus’ presence in retina and further strengthen one of the most compelling pipelines in eye care

此次收购与IRX-101相结合，预计将扩大Tarsus在视网膜领域的布局，并进一步巩固其在眼科护理领域最具竞争力的产品管线之一。

Management to host conference call today, August 6, 2026, at 5:00 a.m. PT / 8:00 a.m. ET

管理层将于今日（2026年8月6日）太平洋时间上午5:00/东部时间上午8:00举行电话会议

IRVINE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (Nasdaq: TARS) (“Tarsus”), today announced that it has entered into a definitive agreement to acquire Alkeus Pharmaceuticals, Inc. (“Alkeus”), a privately held retinal disease-focused biotechnology company developing gildeuretinol (ALK-001), an investigational once-daily oral therapy for Stargardt disease..

加利福尼亚州尔湾，2026年8月6日（环球电讯社）——Tarsus Pharmaceuticals, Inc.（纳斯达克股票代码：TARS）（“Tarsus”）今日宣布，已签订最终协议，收购Alkeus Pharmaceuticals, Inc.（“Alkeus”）。Alkeus是一家专注于视网膜疾病的私营生物技术公司，正在开发gildeuretinol（ALK-001），这是一种用于Stargardt病的在研每日一次口服疗法。

The pending acquisition represents another important step in Tarsus' long-term strategy to build a leading eye care company by bringing differentiated medicines to patients with significant unmet needs. It is expected to expand Tarsus’ growing presence in retina, complement the capabilities established through the acquisition of iRenix Medical, and add a differentiated Phase 3 program potentially addressing Stargardt disease..

此次待完成的收购是Tarsus长期战略中的又一重要举措，旨在通过为存在显著未满足需求的患者提供差异化药物，打造一家领先的眼科护理公司。预计此次收购将扩大Tarsus在视网膜领域日益增长的业务布局， complement 通过收购iRenix Medical所建立的能力，并增加一个差异化的III期临床项目，该项目有望用于治疗Stargardt病。

ALK-001 is a new molecular entity designed to reduce the accumulation of toxic dimers while preserving the normal visual cycle. By reducing the accumulation of these harmful byproducts, ALK-001 is intended to potentially slow retinal damage and preserve vision longer in patients suffering from the potentially blinding disease..

ALK-001 是一种新分子实体，旨在减少有毒二聚体的积累，同时保留正常的视觉循环。通过减少这些有害副产物的积累，ALK-001 有望减缓视网膜损伤，并在患有这种可能导致失明疾病的患者中更长时间地保护视力。

Stargardt disease is an inherited retinal disease that often begins in childhood or adolescence, and progressively and irreversibly damages the central vision patients rely on to read, recognize faces, drive and live independently. This disease is driven by the accumulation of toxic vitamin A dimers that damage retinal cells, highlighting the need for therapies that address the underlying biology of disease.

Stargardt病是一种遗传性视网膜疾病，通常在儿童期或青春期发病，会逐渐且不可逆地损害患者阅读、识别人脸、驾驶和独立生活所依赖的中心视力。该疾病由毒性维生素A二聚体的积累驱动，这些二聚体会损伤视网膜细胞，这凸显了开发针对疾病根本生物学机制的疗法的必要性。

More than 36,000 people in the United States have been clinically diagnosed with Stargardt disease, and there are currently no FDA-approved therapies..

在美国，有超过36,000人被临床诊断为斯塔加特病，目前尚无美国食品药品监督管理局（FDA）批准的疗法。

“From the beginning, our strategy has been to build a leading eye care company by identifying significant diseases where patients have been starving for innovation and bringing forward medicines with the potential to change the standard of care,” said Bobby Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus.

“从一开始，我们的战略就是通过识别那些患者迫切期待创新的重大疾病领域，并推出有望改变治疗标准的药物，从而打造一家领先的眼科护理公司。”Tarsus 首席执行官兼董事长 Bobby Azamian 医学博士、哲学博士表示。

“We believe gildeuretinol has the potential to be a transformational medicine for Stargardt disease and complements the retina capabilities we are already building through IRX-101. We also have tremendous respect for the Alkeus team and the exceptional work they have done to identify and bring forward an optimal asset to potentially address this blinding disease.”.

“我们相信，gildeuretinol 有望成为治疗 Stargardt 病的变革性药物，并与我们正通过 IRX-101 构建的视网膜治疗能力形成互补。我们对 Alkeus 团队及其为识别和推进一款有望应对这一致盲性疾病的优质资产所开展的卓越工作深表敬意。”

“Stargardt disease often begins in childhood or adolescence and progressively takes away the central vision patients depend on throughout their lives. Gildeuretinol is a novel, targeted approach that was designed to address the underlying biology of the disease by reducing the formation of toxic vitamin A dimers while preserving the visual cycle.

“Stargardt病通常在儿童期或青春期发病，并逐渐剥夺患者终生依赖的中心视力。Gildeuretinol是一种新颖的靶向疗法，旨在通过减少有毒维生素A二聚体的形成，同时保留视觉循环，从而针对该疾病的潜在生物学机制进行治疗。”

We are pleased that Tarsus recognizes the potential of gildeuretinol can have on individuals impacted by Stargardt disease, as well as its long-term tolerability profile – an especially important consideration for a therapy that may be used for many years,” said Michel Dahan, President and Chief Executive Officer of Alkeus.

Alkeus 总裁兼首席执行官 Michel Dahan 表示：“我们很高兴 Tarsus 认识到 gildeuretinol 对斯特格氏病（Stargardt disease）患者所具有的潜力，以及其良好的长期耐受性特征——对于一种可能需要使用多年的疗法而言，这一点尤为重要。”

“We have been impressed with the team at Tarsus and their commitment to innovation that meaningfully improves the lives of patients. With Tarsus’ demonstrated leadership in eye care, we are confident in their stewardship of this important therapy and are excited that gildeuretinol will spearhead Tarsus’ expansion into retina therapeutics.”.

“我们对Tarsus团队及其致力于通过创新切实改善患者生活的承诺印象深刻。凭借Tarsus在眼科护理领域展现出的领导力，我们对其管理这一重要疗法充满信心，并很高兴看到gildeuretinol将引领Tarsus向视网膜治疗领域的扩展。”

The clinical program to-date has evaluated ALK-001 across all stages of Stargardt disease, generating encouraging structural, functional and long-term tolerability data, including:

迄今为止的临床项目已在斯特格氏病的所有阶段对 ALK-001 进行了评估，获得了令人鼓舞的结构、功能及长期耐受性数据，包括：

Demonstrated 29.5% slower untransformed, annualized growth rate of atrophic lesions compared to the untreated arm (placebo + natural history), p < 0.001.

与未治疗组（安慰剂 + 自然病程）相比，萎缩性病变的未经转换年化增长率降低了29.5%，p < 0.001。

Evaluated 50 patients with advanced Stargardt disease marked by well-delineated atrophic lesions at baseline in the TEASE-1 study.

在TEASE-1研究中，评估了50例基线时具有边界清晰的萎缩性病变的晚期Stargardt病患者。

Patients treated with ALK-001 were 87% less likely to experience significant loss in low light visual acuity (a 2-line decrease) compared to placebo.

与安慰剂相比，接受 ALK-001 治疗的患者出现低光照视力显著下降（降低 2 行）的可能性降低了 87%。

Evaluated 79 patients with Stargardt disease who had reduced retinal sensitivity but without atrophic lesions at baseline in the TEASE-2 study.

在TEASE-2研究中，评估了79名患有Stargardt病的患者，这些患者在基线时视网膜敏感性降低但无萎缩性病变。

Evaluated in more than 400 patients, with some patients treated for over seven years, providing meaningful tolerability experience for a potential chronic therapy.

在400多名患者中进行了评估，其中部分患者接受的治疗时间超过七年，为潜在的慢性疗法提供了有意义的耐受性数据。

No treatment-related effects on night vision, dark adaptation or color vision have been reported to date.

迄今为止，尚未见与用药相关的对夜视、暗适应或色觉影响的报告。

Together, these studies informed the design of NORTHSTAR, the ongoing Phase 3 trial expected to enroll approximately 230 patients. The primary endpoint will measure the rate of retinal atrophic lesion growth over 24 months, and the secondary endpoint will assess a key aspect of visual function, change in low light visual acuity.

这些研究共同为NORTHSTAR试验的设计提供了依据，这是一项正在进行的III期临床试验，预计将招募约230名患者。主要终点将评估24个月内视网膜萎缩病变的生长速率，次要终点将评估视觉功能的一个关键方面，即低光照视力的变化。

The trial was agreed to by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, and topline data are expected in the second half of 2029..

该试验已获得美国食品药品监督管理局（FDA）和欧洲药品管理局的批准，预计将于2029年下半年公布主要数据。

Pending Transaction Details

待处理交易详情

Upfront Consideration:

前期考量：

approximately $450 million, consisting of $270 million in cash and $180 million in Tarsus common stock

约4.5亿美元，包括2.7亿美元现金和1.8亿美元的Tarsus普通股

Milestones:

里程碑：

up to $350 million upon potential regulatory approval and

在潜在监管批准的情况下，最高可达3.5亿美元

first commercial sale

首次商业销售

Royalties:

版税：

low single digit tiered descending royalties as a percentage of gildeuretinol net sales

按吉尔德雷蒂诺尔净销售额百分比计算的个位数低位阶梯式递减特许权使用费

The Tarsus common stock to be issued to the Alkeus stockholders at closing of the acquisition will be priced at $61.38 per share.

在收购完成时向Alkeus股东发行的Tarsus普通股将以每股61.38美元的价格定价。

The pending transaction with Alkeus has been approved by the Boards of Directors of both companies, and the stockholders of Alkeus and is expected to close in 2026, subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the satisfaction of other customary closing conditions.

与Alkeus的待决交易已获得双方公司董事会及Alkeus股东的批准，预计将于2026年完成交割，但须遵守《哈特-斯科特-罗迪诺反托拉斯改进法》规定的适用等待期届满或终止，并满足其他惯例交割条件。

The closing of the pending acquisition of Alkeus is not contingent upon the receipt of any financing proceeds or any other financing condition. There can be no assurances that the pending acquisition of Alkeus will be consummated on the terms and in the timing described herein or at all..

Alkeus待决收购的完成不以收到任何融资款项或满足任何其他融资条件为前提。无法保证Alkeus的待决收购将按照本文所述的条款和时间表完成，甚至无法保证该收购能够最终完成。

Barclays is acting as exclusive financial advisor to Tarsus and Jefferies is acting as exclusive financial advisor to Alkeus. Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is acting as legal counsel to Tarsus and Latham & Watkins LLP is acting as legal counsel to Alkeus.

巴克莱银行担任塔苏斯公司的独家财务顾问，杰富瑞集团担任阿尔克尤斯公司的独家财务顾问。Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP 律师事务所担任塔苏斯公司的法律顾问，而莱瑟姆·沃特金斯律师事务所（Latham & Watkins LLP）担任阿尔克尤斯公司的法律顾问。

Conference Call and Webcast

电话会议和网络直播

Tarsus will host a conference call and webcast to discuss the acquisition of Alkeus today, August 6, 2026, at 5:00 a.m. PT / 8:00 a.m. ET. A live webcast will be available on the events section of the Tarsus website. A recorded version of the call will be available on the website shortly after the completion of the call and will be archived there for at least 90 days..

Tarsus 将于今天，2026年8月6日，太平洋时间上午5:00/东部时间上午8:00 举办电话会议和网络直播，讨论收购 Alkeus 的事宜。网络直播将在 Tarsus 网站的活动版块提供。电话会议的录音版本将在会议结束后不久上传至网站，并至少存档90天。

About IRX-101

关于IRX-101

IRX-101, is an investigational ocular antiseptic based on a stable aqueous chlorine dioxide solution that is being developed for the potential to reduce post-procedural pain and corneal toxicity in patients receiving intravitreal therapy.

IRX-101是一种在研的眼用抗菌剂，基于稳定的二氧化氯水溶液，正在开发中，旨在降低接受玻璃体内治疗患者的术后疼痛和角膜毒性。

About Gildeuretinol Acetate (ALK-001)

关于吉尔德雷替诺尔乙酸酯（ALK-001）

Gildeuretinol acetate (ALK-001) is an investigational small molecule with once-daily oral formulation targeting toxic Vitamin A dimerization in the retina with a promising tolerability and efficacy profile across 400+ individuals studied.

吉尔德雷替诺尔乙酸酯（ALK-001）是一种在研小分子药物，采用每日一次口服制剂，旨在靶向视网膜中有毒的维生素A二聚化反应，在已研究的400多名受试者中展现出良好的耐受性和疗效。

About Stargardt Disease

关于斯特格氏病

Stargardt disease is a rare, inherited and progressive retinal disease that often begins in childhood or early adulthood. It damages the macula, the central portion of the retina responsible for detailed vision, and can progressively affect patients’ ability to read, recognize faces, drive and live independently.

Stargardt病是一种罕见的遗传性进行性视网膜疾病，通常始于儿童期或成年早期。它会损害负责精细视觉的视网膜中心部分——黄斑，并可能逐渐影响患者的阅读、识别人脸、驾驶和独立生活能力。

There are currently no FDA-approved therapies for Stargardt disease..

目前尚无美国食品药品监督管理局（FDA）批准的斯特格氏病疗法。

About Tarsus Pharmaceuticals, Inc.

关于Tarsus制药公司

Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention.

Tarsus Pharmaceuticals, Inc. 运用经过验证的科学和新技术，以眼科护理为起点，彻底变革患者治疗方式。Tarsus 正在推进其研发管线，以应对眼科、皮肤科和传染病预防等多个治疗领域中存在高度未满足需求的多种疾病。

XDEMVY.

XDEMVY。

®

®

(lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of

（洛替拉纳滴眼液）0.25% 已获美国食品药品监督管理局（FDA）批准，用于治疗

Demodex

蠕形螨

blepharitis. Tarsus is also developing TP-04 for the potential treatment of ocular rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, both of which are in Phase 2, and IRX-101 for potential use as an ocular antiseptic.

睑缘炎。Tarsus 公司也在开发 TP-04，用于潜在治疗眼玫瑰痤疮；开发 TP-05（口服片剂），用于潜在预防莱姆病；这两者均处于二期临床试验阶段。此外，该公司还在开发 IRX-101，用于潜在的眼部抗菌用途。

Forward-Looking Statements

前瞻性陈述

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the potential commercial success and growth of XDEMVY in .

本新闻稿中关于未来预期、计划和前景的陈述，以及任何其他非历史事实的陈述，可能构成“前瞻性陈述”。这些陈述包括有关 XDEMVY 潜在商业成功和增长的陈述。

Demodex

蠕形螨

blepharitis, including market size, acceptance, demand, and adoption rate for XDEMVY; the timing, terms and potential benefits of the pending acquisition of Alkeus; the potential mechanisms of action, therapeutic benefits of and potential market size for gildeuretinol; the potential benefits from the acquisition of iRenix; anticipated regulatory and development milestones; the timing for topline data for, and results of Tarsus’ clinical studies including the NORTHSTAR trial; the test results of ALK-001 and Tarsus’ pipeline formulations; Tarsus’ ability to continue investing in Tarsus’ business and actively evaluate external opportunities, and the quotations of Tarsus’ and Alkeus’ management.

睑缘炎，包括XDEMVY的市场规模、接受度、需求和采用率；待完成的Alkeus收购案的时间安排、条款及潜在收益；gildeuretinol的潜在作用机制、治疗益处及潜在市场规模；收购iRenix可能带来的益处；预期的监管和开发里程碑；Tarsus临床研究（包括NORTHSTAR试验）的顶线数据发布时间及结果；ALK-001的测试结果及Tarsus在研配方；Tarsus持续投资其业务并积极评估外部机会的能力；以及Tarsus和Alkeus管理层的引述。

The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “on track,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words.

“相信”、“考虑”、“继续”、“可能”、“估计”、“预期”、“打算”、“可以”、“或许”、“计划”、“潜在”、“预测”、“规划”、“应当”、“目标”、“将”、“进展顺利”或“会”等词语，或其否定形式及其他类似表述，旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些或类似的识别性词语。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2025 filed on February 23, 2026 and the most recent Form 10-Q quarterly filing filed or to be filed with the SEC on August 6, 2026, copies of which are, or will be posted on its website and are available from Tarsus withou.

由于各种重要因素，实际结果可能与前瞻性陈述所指示的结果存在重大差异。此外，还有其他风险和不确定性可能导致实际结果与前瞻性陈述中列出的结果不同，这些因素在Tarsus向美国证券交易委员会提交的报告中不时详细披露，包括Tarsus于2026年2月23日提交的截至2025年12月31日的年度10-K表格报告，以及将于2026年8月6日提交或已提交给SEC的最新季度10-Q表格报告，这些报告的副本将发布在其网站上，并可通过Tarsus免费获取。

Media Contact:

媒体联系人：

Adrienne Kemp

艾德里安·肯普

Vice President, Corporate Communications

企业传播副总裁

(949) 922-0801

(949) 922-0801

akemp@tarsusrx.com

akemp@tarsusrx.com

Investor Contact:

投资者联系：

David Nakasone

大卫·中曾根

Head of Investor Relations

投资者关系负责人

(949) 620-3223

(949) 620-3223

DNakasone@tarsusrx.com

DNakasone@tarsusrx.com