Cullinan Therapeutics Files 8-K

TL;DR

Cullinan Therapeutics filed an 8-K on 5/23/24, check for updates.

AI Summary

Cullinan Therapeutics, Inc. (formerly Cullinan Oncology, Inc.) filed an 8-K on May 23, 2024, reporting on other events and financial statements. The company, incorporated in Delaware, is based in Cambridge, Massachusetts, and operates in the biological products sector.

Why It Matters

This filing provides updates on the company's corporate activities and financial reporting, which are crucial for investors to stay informed about the company's status.

Risk Assessment

Risk Level: low — This is a routine filing that primarily provides corporate and financial information without announcing significant new risks or material events.

Key Numbers

• 001-39856 — SEC File Number (Identifies the company's filing history 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
• Cullinan Management, Inc. (company) — Former company name
• Cullinan Oncology, LLC (company) — Former company name
• May 23, 2024 (date) — Date of earliest event reported
• One Main Street Suite 1350 (address) — Principal executive office address
• Cambridge, Massachusetts (location) — Principal executive office location
• 02142 (zip_code) — Principal executive office zip code

FAQ

Key Financial Figures

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

Filing Documents

• cgem-20240523.htm (8-K) — 70KB
• cgem-ex99_1.htm (EX-99.1) — 55KB
• 0000950170-24-064025.txt ( ) — 252KB
• cgem-20240523.xsd (EX-101.SCH) — 25KB
• cgem-20240523_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On May 23, 2024, Cullinan Therapeutics, Inc. (the "Company" or "Cullinan") issued a press release related to the announcement of the first clinical data in combination with a checkpoint inhibitor ("CPI") and updated monotherapy clinical data from its Phase 1 study dose escalation cohort of CLN-619 in patients with advanced solid tumors. 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. Cullinan will host an investor event on Saturday, June 1, 2024, at 6:30 pm Central Time, during which its Chief Medical Officer, Dr. Jeff Jones, MD, MBA, will present an overview of the CLN-619 data shared at the 2024 American Society of Clinical Oncology ("ASCO") Annual Meeting on June 1, 2024, and Dr. Alexander Spira, MD, PhD, FACP, FASCO, Director, Virginia Cancer Specialists Research Institute and Director, NEXT Oncology Virginia, will share an overview of the current treatment landscape for epidermal growth factor receptor ("EGFR") mutated non-small-cell lung cancer ("NSCLC"). Investors and analysts are invited to register to attend in-person by emailing Chad Messer, VP Investor Relations of the Company at cmesser@cullinantx.com. A live webcast will be available via the events page of the Company's investor relations website at https://cullinantherapeutics.com/events-and-presentations/, and a replay will be available shortly after the conclusion of the live event. 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

01 Other Events

Item 8.01 Other Events. On May 23, 2024, the Company announced the first clinical data in combination with CPI and updated monotherapy clinical data from its Phase 1 study dose escalation cohort of CLN-619 in patients with advanced solid tumors. CLN-619 is being studied in an ongoing Phase 1 clinical trial both as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. The preliminary clinical data from CLN-619 in combination with CPI pembrolizumab demonstrated objective tumor responses, across multiple tumor types, as shown in the table below. Tumor Type Number of Prior Lines of Therapy Prior CPI CPI Responsive Tumor (Yes/No?) Best Response Duration of Response (Weeks) NSCLC, EGFR exon 18/21 6 No No PR 1 24 NSCLC, ALKr 2 No No PR 12.7 Gastric, HER2+ 3 No Yes PR 8.9+ (ongoing) 1 Partial response = PR Three partial responses were observed in patients with tumor types typically unresponsive to CPI treatment, including EGFR-mutated NSCLC patients. The preliminary clinical data from CLN-619 as a monotherapy demonstrated objective tumor responses and stable disease, across multiple tumor types, as shown in the table below. Tumor Type Number of Prior Lines of Therapy Best Response Duration of Response (Weeks) Responders (n=3) Mucoepidermoid parotid 2 CR 1 71 Endometrial (serous, MMRp) 5 PR 2 31 Endometrial (endometrioid, MMRp) 3 PR 55+ (ongoing) SD 3 18 weeks (n=9) Cervical squamous (n=2); breast (ER/PR+, HER2 ; n=1); ovarian (n=1); endometrial carcinosarcoma (n=1); mediastinal intimal sarcoma (n=1); adenoid cystic carcinoma (n=1); pancreatic adenocarcinoma ( KRAS G12V; n=1); NSCLC ( STK11 m; n=1) Mean: 3.6 Range: 1–7 SD 18 wks Range: 18–56 1 Complete response = CR 2 Partial response = PR 3 Stable disease = SD One complete response, two partial responses and nine stable disease results were observed, and the clinical benefit rat

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 May 23, 2024, 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: May 23, 2024 By: /s/ Mary Kay Fenton Mary Kay Fenton Chief Financial Officer

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View this 8-K filing on SEC EDGAR