Cullinan Therapeutics Files 8-K

Ticker: CGEM · Form: 8-K · Filed: Oct 16, 2024 · CIK: 1789972

Cullinan Therapeutics, Inc. 8-K Filing Summary
FieldDetail
CompanyCullinan Therapeutics, Inc. (CGEM)
Form Type8-K
Filed DateOct 16, 2024
Risk Levellow
Pages4
Reading Time5 min
Key Dollar Amounts$0.0001
Sentimentneutral

Sentiment: neutral

Topics: corporate-filing, regulatory

TL;DR

Cullinan Therapeutics (formerly Cullinan Oncology) filed an 8-K on Oct 16, 2024.

AI Summary

Cullinan Therapeutics, Inc. filed an 8-K on October 16, 2024, reporting on other events and financial statements. The company, formerly known as Cullinan Oncology, Inc., is based in Cambridge, MA, and operates in the biological products sector.

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 — This is a routine filing that does not appear to contain significant new information that would immediately impact the company's risk profile.

Key Players & Entities

  • Cullinan Therapeutics, Inc. (company) — Registrant
  • Cullinan Oncology, Inc. (company) — Former company name
  • October 16, 2024 (date) — Date of report
  • Cambridge, Massachusetts (location) — Principal business address

FAQ

What is the primary business of Cullinan Therapeutics, Inc.?

Cullinan Therapeutics, Inc. is in the business of Biological Products (No Diagnostic Substances), as indicated by its Standard Industrial Classification code [2836].

When did Cullinan Therapeutics, Inc. change its name?

The company was formerly known as Cullinan Oncology, Inc. and the date of the name change was February 25, 2021.

What is the principal business address of Cullinan Therapeutics, Inc.?

The principal business address is One Main Street, Suite 1350, Cambridge, Massachusetts, 02142.

What is the filing date of this 8-K report?

The report was filed on October 16, 2024.

What are the main items reported in this 8-K filing?

This 8-K filing includes information on Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits.

Filing Stats: 1,259 words · 5 min read · ~4 pages · Grade level 13.4 · Accepted 2024-10-16 07:17:23

Key Financial Figures

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

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On October 16, 2024, Cullinan Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") had cleared the Company's Investigational New Drug Application ("IND") for CLN-978 in systemic lupus erythematosus ("SLE"). 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. Additionally, the Company has updated the corporate presentation it presents to investors from time to time. A copy of the updated corporate presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K. The information in this report furnished pursuant to Item 7.01, including Exhibits 99.1 and 99.2 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 October 16, 2024, the Company announced that the FDA had cleared the Company's IND application for CLN-978 in SLE. With the IND clearance, the Company may proceed with its global Phase 1 clinical trial in the U.S. to assess CLN-978 in patients with moderate to severe SLE. The trial will enroll patients with a systemic lupus erythematosus disease activity index score of eight or greater and who have had an inadequate response to at least two treatments, including one immunosuppressive or biologic standard-of-care agent. Part A is a dose escalation phase that will determine the target dose for further development, with a starting dose of 10 micrograms. Part B is a dose expansion phase which will explore multiple dose schedules informed by data from Part A of the study. The primary objective of the study is to evaluate the safety of CLN-978 for treatment of active moderate to severe SLE. Secondary objectives include pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity. 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 preclinical and clinical development plan and timeline, the clinical and therapeutic potential of CLN-978, the strategy of CLN-978, and our research and development activities are forward-looking statements. 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 Fo

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 October 16, 2024, furnished herewith 99.2 Corporate presentation 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: October 16, 2024 By: /s/ Mary Kay Fenton Mary Kay Fenton Chief Financial Officer

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