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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 20, 2026

FREENOME, INC.
\n

(Exact name of registrant as specified in its charter)

\n\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n\n

\n Delaware \n \n		\n 001-42126 \n \n		\n 98-1783595 \n \n
\n (State or other jurisdiction of incorporation) \n		\n (Commission File Number) \n		\n (IRS Employer Identification No.) \n

Genesis Marina, 3300 Marina Blvd,

Brisbane, CA 94005

(Address of principal executive offices including zip code)

Registrant’s telephone number, including area code: (650) 446-6630

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the\n following provisions:

\n\n\n \n\n \n\n \n\n \n\n\n

☐ \n	\n Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) \n

\n\n\n \n\n \n\n \n\n \n\n\n

☐ \n	\n Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) \n

\n\n\n \n\n \n\n \n\n \n\n\n

☐ \n	\n Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) \n

\n\n\n \n\n \n\n \n\n \n\n\n

☐ \n	\n Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) \n

Securities registered pursuant to Section 12(b) of the Act:

\n\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n\n

Title of each class

Trading Symbol

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share
\n

FRNM
\n

The Nasdaq Capital Market
\n

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this\n chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new\n or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

\n\n\n \n\n \n\n \n\n \n\n\n

Item 7.01.

Regulation FD Disclosure

On October 20, 2026, Freenome, Inc. (the “Company”) issued a press release titled “Freenome Expands Personalized Cancer Detection Portfolio, Launching\n SimpleScreen™ Lung Test With FDA-Approved SimpleScreen CRC Option.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed\n “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities\n Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

\n\n\n \n\n \n\n \n\n \n\n\n

Item 8.01.

Other Events

2026年10月20日，公司宣布推出SimpleScreen™ Lung，这是一种首创的解决方案，使符合条件的患者可以通过一次抽血同时筛查肺癌和结直肠癌（“CRC”），该方案使用两种独立验证的、针对特定适应症的检测方法。公司的个性化癌症检测方法结合了基于风险的筛查与一系列单癌种和多癌种检测，这些检测是专门为每个群体开发的，以满足个体患者的筛查需求。

SimpleScreen Lung在一项针对50至80岁、有≥20年吸烟史且符合美国癌症协会（“ACS”）肺癌筛查资格的成年人的病例对照研究中进行了临床验证。在一项独立队列研究中，172例肺癌病例和436例对照组中，该检测在50%特异性下达到了85%的敏感性，并且具有99.8%的阴性预测值（“NPV”）。这意味着，在1000名检测结果为阴性的人中，大约有2人可能患有肺癌。对于I期的敏感性为82%，II期为75%，III期为91%，IV期为94%。

性能估计值已根据年龄、性别、肺癌分期和组织学亚型的目标分布进行了调整。预期使用人群包括无论何时戒烟的前吸烟者，这与2023年ACS肺癌筛查指南更新一致。

在公司针对CRC的PREEMPT研究中，该研究招募了超过48,000名参与者，该检测在CRC中的敏感性为81%，对晚期结直肠肿瘤的特异性为90%，在根据2020年美国人口普查的年龄和性别分布调整后的分析中，其NPV为99.9%。

前瞻性声明

本8-K表格当前报告中作出的声明以及与本报告一同提交或备案的某些材料可能包含并非历史事实的陈述，并根据《1933年证券法》第27A条和《1934年证券交易法》第21E条的定义，被视为前瞻性声明，通常通过使用“预期”、“相信”、“估计”、“期望”、“意图”、“可能”、“计划”、“项目”、“寻求”、“应”、“将”等词语或类似表达来识别。本8-K表格当前报告中任何并非历史事实的陈述可能被视为前瞻性声明。这些前瞻性声明包括但不限于关于SimpleScreen投资组合和个性化癌症检测影响及扩大患者覆盖能力的明确或隐含声明。这些前瞻性声明反映了公司当前对其计划、意图、期望、策略和前景的看法，这些看法基于公司目前可获得的信息和公司所做的假设。尽管公司认为这些前瞻性声明中反映或暗示的计划、意图、期望、策略和前景是合理的，但公司无法保证这些计划、意图、期望或策略能够实现。此外，实际结果可能与前瞻性声明中描述的结果有重大差异，并将受到多种超出公司控制范围的风险和因素的影响，包括但不限于与公司产品和检测审批相关的风险以及预期监管和业务里程碑的时间；与潜在客户达成最终合同安排的能力；竞争性产品和检测的影响；获得足够材料供应的能力；获得额外融资的能力；吸引和留住合格人员的能力；全球经济和政治状况；法律和监管变化；可能针对公司提起的任何法律诉讼的结果；竞争对公司未来业务的影响；以及在向SEC提交的S-1表格中列出的那些风险，以及随后提交的SEC文件中更新的内容。公司不对公开更新任何前瞻性声明承担义务，无论是否由于新信息、未来事件或其他原因。

\n\n\n \n\n \n\n \n\n \n\n\n

第9.01项。

财务报表和附录。

(d) 附录。

\n\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n\n

\n 99.1 \n	\n Freenome, Inc.于2026年10月20日发布的新闻稿，随本文件一同提交。 \n

\n 104 \n	\n 封面页面交互式数据文件（嵌入在Inline XBRL文档中）。 \n

签名

根据《交易法》的要求，注册人已 duly 委托本报告由下文签署人 duly 授权签署。

\n\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n\n

\n FREENOME, INC. \n

\n 由： \n	\n /s/ Aaron Elliott \n
\n 姓名： \n	\n Aaron Elliott \n
\n 职位： \n	\n 首席执行官 \n

\n 日期：2026年10月20日 \n

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