Cullinan Therapeutics Files 8-K

TL;DR

Cullinan Therapeutics filed an 8-K on 12/08/25. No major news, just routine updates.

AI Summary

Cullinan Therapeutics, Inc. filed an 8-K on December 8, 2025, reporting on other events and financial statements. The company, formerly known as Cullinan Oncology, Inc., is incorporated in Delaware and headquartered in Cambridge, MA.

Why It Matters

This filing provides an update on the company's corporate activities and financial reporting, which is important for investors to stay informed about the company's status.

Risk Assessment

Risk Level: low — The filing appears to be a routine corporate disclosure without any immediate negative or positive financial implications.

Key Players & Entities

• Cullinan Therapeutics, Inc. (company) — Registrant
• Cullinan Oncology, Inc. (company) — Former company name
• December 08, 2025 (date) — Date of earliest event reported
• Cambridge, Massachusetts (location) — Company headquarters

FAQ

Key Financial Figures

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

Filing Documents

• cgem-20251208.htm (8-K) — 65KB
• cgem-ex99_1.htm (EX-99.1) — 58KB
• 0001193125-25-310764.txt ( ) — 240KB
• cgem-20251208.xsd (EX-101.SCH) — 24KB
• cgem-20251208_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 8, 2025, Cullinan Therapeutics, Inc. (the "Company") issued a press release announcing that the Company presented updated 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"). 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 December 8, 2025, the Company presented updated clinical data from its Phase 1 study of CLN-049 in patients with r/r AML and MDS at the ASH Annual Meeting. Efficacy Results As of the August 2025 data cutoff, 45 patients (39 AML, 3 MDS/AML, and 3 MDS) were enrolled without regard to FLT3 cell surface expression across eight cohorts (target dose range 1.5-12 g/kg). 41 patients across seven cohorts were efficacy evaluable, having reached at least one on-treatment 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 (calculated as CR/complete remission with incomplete recovery ("CRi")/complete remission with partial hematologic recovery ("CRh")). Promising monotherapy activity was observed in heavily pretreated patients with AML at clinically active target doses: At the highest target dose studied thus far of 12 g/kg (n=16), the CR/CRh rate was 31% (5/16) and the CRc rate was 31% (5/16). Anti -leukemic activity was observed at target doses 6 g/kg (n=32), with a CR/CRh rate of 25% (8/32) and a CRc rate of 28% (9/32). Data show promising initial durability in responders, including measurable residual disease ("MRD") negativity: Atefficacious doses (6 g/kg), in the patients achieving a CR/ CRh response, 63% (5/8) of patients had aduration of response of >16 weeks and two additional patients were able to proceed to allogeneic hematopoietic stem cell transplant. In 10/32 patients achieving bone marrow blasts <5% at a target dose of 6 g/kg, 30% (n=3) of patients were MRD negative by flow cytometry and one MRD-negative patient has had an ongoing response for >36 weeks. Encouraging responses were observed in difficult-to-treat AML patients with high-risk genetic features: Notably, among the eight patients with TP53 -mutated AML tre

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 December 8, 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: December 8, 2025 By: /s/ Mary Kay Fenton Mary Kay Fenton Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR