Cullinan Therapeutics Files 8-K

TL;DR

Cullinan Therapeutics filed an 8-K on Nov 3, 2025, covering disclosures and other events.

AI Summary

Cullinan Therapeutics, Inc. filed an 8-K on November 3, 2025, reporting on various events. The filing includes information related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company, formerly known as Cullinan Oncology, Inc., is incorporated in Delaware and headquartered in Cambridge, MA.

Why It Matters

This 8-K filing provides updates on regulatory disclosures and other corporate events for Cullinan Therapeutics, Inc., which is important for investors to stay informed about the company's status.

Risk Assessment

Risk Level: low — This filing is a routine corporate disclosure and does not appear to contain significant new risks.

Key Numbers

• 001-39856 — SEC File Number (Identifies the company's filing with the SEC)
• 81-3879991 — IRS Employer Identification No. (Company's tax identification number)

Key Players & Entities

• Cullinan Therapeutics, Inc. (company) — Registrant
• Cullinan Oncology, Inc. (company) — Former company name
• November 03, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of Incorporation
• Cambridge, Massachusetts (location) — Business Address City, State

FAQ

Key Financial Figures

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

Filing Documents

• cgem-20251103.htm (8-K) — 57KB
• cgem-ex99_1.htm (EX-99.1) — 59KB
• 0001193125-25-261799.txt ( ) — 232KB
• cgem-20251103.xsd (EX-101.SCH) — 24KB
• cgem-20251103_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On November 3, 2025, Cullinan Therapeutics, Inc. (the "Company") issued a press release announcing that the Company is presenting new clinical data from its Phase 1 study of CLN-049 in patients with relapsed/refractory ("r/r") acute myeloid leukemia ("AML") and myelodysplastic syndrome ("MDS") at the 67th American Society of Hematology Annual Meeting and Exposition (the "ASH Annual Meeting") in December. 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. On November 3, 2025, the Company announced new clinical data from its Phase 1 study of CLN-049 in patients with r/r AML and MDS. The Company will present the data at the ASH Annual Meeting in December. Efficacy Results As of the June 2025 data cutoff, 40 patients (34 AML patients and six MDS patients) were enrolled without regard to FLT3 cell surface expression across seven cohorts (target dose range 1.5-12 g/kg), and 29 patients with AML were efficacy evaluable (1 response assessment). Patients with AML had received a median of two prior therapies (range: 1-8). For AML, response was assessed using ELN 2022 criteria. Efficacy endpoints include complete response ("CR") rate, composite complete response ("CRc") rate and overall response rate ("ORR"). CLN-049 achieved promising anti-leukemic activity in this heavily pretreated AML population: Anti-leukemic activity was observed at target doses 6 g/kg (n=23, all AML), with a CRc rate of 30%, and ORR of 57%. At the highest target dose studied thus far of 12 g/kg (n=13), CRc rate was 31% and ORR was 69%. In 9/23 patients achieving bone marrow blasts <5%, 33% (n=3) patients were MRD negative by flow cytometry; relapse was not observed in MRD-negative patients, and one patient has remained on study for >6 months. Responses were observed in patients with AML regardless of baseline genetic risk. Notably, among five patients with TP53 -mutated AML treated at 12 g/kg, four responses (2 CRh, 2 MLFS) were observed. Dose escalation continues in this ongoing Phase 1 study. Safety Results As of the June 2025 data cutoff, the data indicate a manageable safety profile in a broad population of patients with r/r AML and MDS (n=40): The most common treatment-emergent adverse events ("TEAEs") included cytokine release syndrome ("CRS") (40%), infusion-related reaction (35%), and febrile neutropenia, pneumonia, stomatitis, white blood cell count decrease (17.5% each). All CRS events were l

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibit No. Description 99.1 Press release issued by Cullinan Therapeutics, Inc. on November 3, 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: November 3, 2025 By: /s/ Mary Kay Fenton Mary Kay Fenton Chief Financial Officer

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View this 8-K filing on SEC EDGAR