Cullinan Therapeutics Files 8-K

TL;DR

Cullinan Therapeutics (formerly Cullinan Oncology) filed an 8-K on Jan 29, 2025, covering events from Jan 28, 2025.

AI Summary

Cullinan Therapeutics, Inc. (formerly Cullinan Oncology, Inc.) filed an 8-K on January 29, 2025, reporting events as of January 28, 2025. The filing includes information on Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company is based in Cambridge, MA.

Why It Matters

This 8-K filing provides updates on regulatory disclosures, other significant events, and financial statements for Cullinan Therapeutics, Inc.

Risk Assessment

Risk Level: low — This is a routine 8-K filing for corporate disclosures and does not appear to contain significant new risks.

Key Players & Entities

• Cullinan Therapeutics, Inc. (company) — Registrant
• Cullinan Oncology, Inc. (company) — Former company name
• January 28, 2025 (date) — Date of earliest event reported
• January 29, 2025 (date) — Date of report
• Cambridge, Massachusetts (location) — Principal executive office location

FAQ

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share CGEM The Nasdaq

Filing Documents

• cgem-20250128.htm (8-K) — 49KB
• cgem-ex99_1.htm (EX-99.1) — 36KB
• img184014297_0.jpg (GRAPHIC) — 15KB
• img184014297_1.jpg (GRAPHIC) — 13KB
• img184014297_2.jpg (GRAPHIC) — 17KB
• 0000950170-25-010199.txt ( ) — 267KB
• cgem-20250128.xsd (EX-101.SCH) — 24KB
• cgem-20250128_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On January 28, 2025, Cullinan Therapeutics, Inc. (the "Company") issued a joint press release with Taiho Pharmaceutical Co., Ltd. and Taiho Oncology, Inc. announcing that the REZILIENT1 trial met its primary endpoint of overall response rate. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this report furnished pursuant to Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed "filed" for the 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. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.

01 Other Events

Item 8.01 Other Events. The REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib monotherapy in patients with non-small cell lung cancer harboring the epidermal growth exon 20 insertion mutations who have received prior therapy, met its primary endpoint of overall response rate. The safety profile was generally consistent with previous data presentations. These results are based on the Phase 2b part of this study. The full results from the REZILIENT1 trial will be submitted for presentation at an upcoming international medical conference. Pending discussions with the United States Food and Drug Administration, the companies plan to submit for United States regulatory approval in the second half of 2025. Cautionary Note Regarding Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Current Report on Form 8-K, including express or implied statements regarding the Company's beliefs and expectations related to our plans regarding future data presentations, the clinical development plan and timeline of zipalertinib and other statements that are not historical facts. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "seek," "should," "target," "will," or the negative of these terms or other comparable terminology. Any forward-looking statements in this Current Report on Form 8-K are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release issued by Cullinan Therapeutics, Inc. on January 28, 2025, furnished herewith 104 Cover page from this Current Report on Form 8-K, formatted in Inline XBRL

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. CULLINAN THERAPEUTICS, INC. Date: January 29, 2025 By: /s/ Mary Kay Fenton Mary Kay Fenton Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR