NEW YORK--(

纽约--(

BUSINESS WIRE

商业热线

)--OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has entered into agreements for the commercial manufacture of OST-HER2. The Company is currently organizing additional data in relation to the recently-completed treatment phase of its Phase 2b trial of OST-HER2 in the prevention of recurrence of lung metastatic osteosarcoma in preparation for a Type B or Type C meeting with the US Food & Drug Administration (“FDA”).

)--OS Therapes，Inc.（NYSE-A:OSTX）是一家临床阶段生物技术公司，致力于免疫疗法和靶向药物偶联物的癌症治疗，今天宣布，它已经签署了OST-HER2商业制造协议。该公司目前正在组织有关最近完成的OST-HER2 2b期临床试验治疗阶段的额外数据，以预防肺转移性骨肉瘤的复发，为与美国食品和药物管理局（“FDA”）举行的B型或C型会议做准备。

Following the FDA meeting, the Company anticipates that it will be submitting a Biologics Licensing Authorization (BLA) application to the FDA for accelerated or conditional approval consideration..

在FDA会议之后，该公司预计将向FDA提交生物制剂许可授权（BLA）申请，以加速或有条件批准。。

About OS Therapies

关于操作系统疗法

OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein.

OS Therapes是一家临床阶段肿瘤公司，专注于骨肉瘤（OS）和其他实体瘤治疗的鉴定，开发和商业化。该公司的主要资产OST-HER2是一种免疫疗法，利用李斯特菌的免疫刺激作用，启动针对HER2蛋白的强烈免疫反应。

OST-HER2 has received rare pediatric disease, fast-track and orphan drug designations from the US FDA. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, with positive results released in the first quarter of 2025.

。该公司已经完成了OST-HER2在复发性，完全切除的肺转移性骨肉瘤中的41例2b期临床试验的登记，并于2025年第一季度发布了阳性结果。

The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer.

该公司预计在2025年向美国FDA提交骨肉瘤中OST-HER2的生物制剂许可申请（BLA），如果获得批准，将有资格获得优先审查凭证，然后出售。OST-HER2除了在各种乳腺癌模型中显示临床前疗效数据外，还完成了主要针对乳腺癌患者的1期临床研究。

OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma..

OST-HER2已被美国农业部有条件批准用于治疗患有骨肉瘤的犬科动物。。

In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as

此外，OS Therapes正在推进其下一代抗体-药物偶联物（ADC）平台，称为

tunable ADC

可调ADC

(tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone linker technology, enabling the delivery of multiple payloads per linker. For more information, please visit

（tADC），其特征在于可调的定制抗体接头有效载荷候选物。该平台利用该公司专有的硅胶接头技术，可以为每个接头提供多个有效载荷。有关更多信息，请访问

www.ostherapies.com

www.ostherapies.com

.

.

Forward-Looking Statements

前瞻性声明

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 within the meaning of the federal securities laws. These forward-looking statements and terms such as 'anticipate,' 'expect,' 'intend,' 'may,' 'will,' 'should' or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future.

。这些前瞻性陈述和术语，如“预期”、“预期”、“打算”、“可能”、“将会”、“应该”或其他类似术语，涉及风险和不确定性，因为它们与事件有关，并取决于未来将发生的情况。

Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q.

这些陈述包括关于操作系统疗法及其管理层成员的意图，信念或当前期望的陈述，以及这些陈述所基于的假设。。

Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information.

本新闻稿中包含的任何前瞻性声明仅在本新闻稿发布之日起生效，除联邦证券法要求外，OS Therapes明确否认任何更新任何前瞻性声明的义务，无论是由于新信息。