附件 99.1

Checkpoint Therapeutics报告第三季度 2024财务结果及近期公司动态

生物制品许可申请 提交给美国FDA正在审核中

PDUFA目标日期为 2024年12月28日

马萨诸塞州沃尔瑟姆 – 2024年11月12日 – Checkpoint Therapeutics, Inc.（“Checkpoint”）（纳斯达克：CKPT），是一家临床阶段的免疫治疗和靶向肿瘤学公司， 今天宣布截至2024年9月30日的第三季度财务结果和近期公司动态。

“随着处方药用户收费法 （“PDUFA”）目标日期设定在下个月，我们正等待美国食品药品监督管理局（“FDA”）对我们的生物制品许可申请（“BLA”）重新提交 cosibelimab 的决定，”Checkpoint的总裁兼首席执行官James Oliviero说道。“本月从行使现有warrants获得的920万美元现金收入增强了我们的资产负债表，使其能够延续到我们的PDUFA日期以及2025年。我们 现在全力专注于为cosibelimab的潜在批准做准备，并期待着为肿瘤医生提供一种新的、差异化的治疗选择，以治疗晚期鳞状细胞癌（“cSCC”）患者。”

最近的公司更新：

财务业绩：

关于Checkpoint Therapeutics

Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential differentiated anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com.

前瞻性声明

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our resubmission of our BLA for cosibelimab and review thereof, our belief that the BLA resubmission potentially addresses all the issues in the CRL, our belief about the comprehensive nature of our BLA resubmission and reaching alignment with the FDA on our cosibelimab BLA resubmission strategy, our ability to work with our third-party contract manufacturing organization (“CMO”) and the FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential marketing approval of cosibelimab, the adequacy of the responses to the inspection issues submitted to FDA by our third-party CMO, our projections of regulatory review timelines, the commercial potential of cosibelimab, if approved, and the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-programmed death receptor-1 therapies and the dual mechanism of action of cosibelimab translating into potential enhanced efficacy. Factors that could cause our actual results to differ materially include the following: the risks and uncertainties associated with the regulatory review process; uncertainties regarding the timeline of FDA review of the resubmitted BLA; any inability to successfully work with the FDA to find a satisfactory solution to address any concerns in a timely manner or at all during the review process for the BLA, including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA; our, and our third party CMO’s, ability to adequately address the issues raised in the CRL; issues associated with any facility inspection or re-inspection of our third party CMO or otherwise during the review process for the BLA; the risk that our third-party CMO will not meet deadlines, and/or comply with applicable regulations; whether the FDA accepts the data and results as included in the BLA resubmission at levels consistent with the published results, or at all; our ability to execute a partnering or other relationship to enable the commercialization of cosibelimab, if approved, on acceptable terms, if at all; the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Quarterly Report on Form 10-Q for the period ended June 30, 2024, and in our subsequent other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

本新闻稿中所列的任何前瞻性陈述仅在本新闻稿的日期上有效。我们明确不承担任何义务或承诺，公开发布对本文件中包含的任何前瞻性陈述的任何更新或修订，以反映我们的期望的任何变化或基于任何此类声明的事件、条件或情况的变化，除非法律要求。本新闻稿及以往公告可在www.checkpointtx.com获取。我们网站上的信息不作为本新闻稿的引用，并仅供参考。

公司联系人：

Jaclyn Jaffe

Checkpoint Therapeutics, Inc.

(781) 652-4500

ir@checkpointtx.com

投资者关系联系人：

Ashley R. Robinson

Managing Director, LifeSci Advisors, LLC

(617) 430-7577

arr@lifesciadvisors.com

媒体关系联系人：

Katie Kennedy

Gregory FCA

610-731-1045

checkpoint@gregoryfca.com

先导疗法公司

简明资产负债表

(以千为单位，除股份和每股金额外)

(未经审计)

先导疗法公司

捷凯收购公司二期有限公司

(以千为单位，除股份和每股金额外)

(未经审计)