# EDGAR Filing Document

**Accession Number:** 0001789972
**File Stem:** 0001193125-25-268041
**Filing Date:** 2025-11
**Character Count:** 20900
**Document Hash:** dc7282848867ada66f5a758964df9dbc
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-268041.hdr.sgml**: 20251106

**ACCESSION NUMBER**: 0001193125-25-268041

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20251106

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251106

**DATE AS OF CHANGE**: 20251106

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Cullinan Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001789972
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 813879991
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39856
- **FILM NUMBER:** 251456077

**BUSINESS ADDRESS:**
- **STREET 1:** ONE MAIN STREET
- **STREET 2:** SUITE 1350
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02142
- **BUSINESS PHONE:** 617-410-4650

**MAIL ADDRESS:**
- **STREET 1:** ONE MAIN STREET
- **STREET 2:** SUITE 1350
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02142

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cullinan Oncology, Inc.
- **DATE OF NAME CHANGE:** 20210225

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cullinan Management, Inc.
- **DATE OF NAME CHANGE:** 20210107

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cullinan Oncology, LLC
- **DATE OF NAME CHANGE:** 20191001

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** November 06, 2025<br>

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CULLINAN THERAPEUTICS, INC.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-39856 | 81-3879991 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| One Main Street<br>Suite 1350 |  |  |
| Cambridge**,** Massachusetts |  | 02142 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 617 410-4650<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | |
|:---|:---|
| **<br>Title of each class** | **<br>Name of each exchange on which registered** |
| Common Stock, $0.0001 par value per share<br> CGEM | The Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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## Item 2.02 Results of Operations and Financial Condition.
On November 6, 2025, Cullinan Therapeutics, Inc. (the "Company") announced its financial results for the quarter ended September 30, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed "filed" for 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

## Item 8.01 Other Events.
As of September 30, 2025, the Company's cash, cash equivalents, short- and long-term investments, and interest receivable were $475.5 million. The Company expects its cash resources to provide runway into 2029 under its new operating plan.

**Forward Looking Statements**

This Current Report on Form 8-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this Current Report on Form 8-K that are not historical facts may be considered "forward-looking statements," including statements regarding the Company's estimates of cash, cash equivalents, investments, and interest receivable as of September 30, 2025. Forward-looking statements are typically, but not always, identified by the use of words such as "expect," and other similar 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 the Company's actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with market conditions, risks and uncertainties associated with the Company's business and finances in general, as well as the risks detailed in the Company's recent filings on Forms 10-K and 10-Q with SEC. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this Current Report on Form 8-K. Any forward-looking statement included in this Current Report on Form 8-K speaks only as of the date on which it was made.

## Item 9.01 Financial Statements and Exhibits.
(d) Exhibits

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| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Description</u> |
| 99.1 | [<u>Press release issued by Cullinan Therapeutics, Inc. on November 6, 2025, furnished herewith</u>](cgem-ex99_1.htm) |
| 104 | Cover page from this Current Report on Form 8-K, formatted in Inline XBRL |

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**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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **CULLINAN THERAPEUTICS, INC.** |
| Date: | November 6, 2025 | By:  | /s/ Mary Kay Fenton |
|  |  |  | Mary Kay Fenton<br>Chief Financial Officer |

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## Exhibit 99.1

**Cullinan Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results**

*Promising Phase 1 clinical data for CLN-049, a FLT3xCD3 bispecific T cell engager, demonstrating ~30% CRc rate in heavily pretreated, all-comer population of patients with relapsed/refractory AML to be presented in oral presentation at ASH 2025*

*Company to share initial data for CLN-978, a CD19xCD3 bispecific T cell engager, in both SLE and RA in first half of 2026*

*Based on review of emerging clinical data, CLN-619 and CLN-617 programs discontinued*

*Cash and investments of $475.5 million as of September 30, 2025; Runway into 2029*

CAMBRIDGE, Mass. November 6, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company accelerating potential high-impact therapies in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights and announced its financial results for the third quarter ended September 30, 2025.

"Cullinan is strategically focusing resources and development efforts on select, high-conviction clinical stage programs. We are well-positioned to further concentrate resources on CLN-978, a CD19xCD3 bispecific T cell engager, and we plan to share initial clinical data in autoimmune diseases in the first half of 2026. We are also particularly encouraged by the emerging efficacy profile of CLN-049, our FLT3xCD3 bispecific T cell engager, and we look forward to unveiling important clinical data in an oral presentation at the upcoming 2025 ASH Annual Meeting in December. We believe the differentiated mechanism of CLN-049 supports its potential to address a broad population of AML patients regardless of mutational status, including those with poor prognostic features," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.

"Additionally, following a positive pre-NDA meeting with the FDA in October, our partner Taiho plans to initiate a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins NSCLC by year-end and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. Finally, after reviewing emerging clinical data, we have decided not to pursue further development of CLN-619 and CLN-617. Notably, our core pipeline is now focused on T cell engagers applied to well-validated targets with transformative potential in immunology and oncology. This focused pipeline extends our cash runway into 2029 and provides us ample financial resources to deliver meaningful value-driving catalysts across our programs in 2026 and beyond."

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**Portfolio Highlights**

**Immunology**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**CLN-978 (CD19xCD3 bispecific T cell engager):** Systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's disease (SjD).

oThe Phase 1 OUTRACE Program is enrolling and treating patients across the OUTRACE SLE, OUTRACE RA and OUTRACE SjD Studies. The Company plans to share initial safety and B cell depletion data in SLE and RA in the first half of 2026.

oThe Company was issued a key composition of matter patent by the United States Patent and Trademark Office, which is expected to extend patent protection until at least 2042, excluding possible patent term extension.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Velinotamig (BCMAxCD3 bispecific T cell engager):** Autoimmune diseases

oGenrix Bio, from whom Cullinan licensed velinotamig in June 2025, plans to initiate a Phase 1 study in China in patients with autoimmune diseases by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.

**Oncology**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology:** EGFR ex20ins NSCLC

oFollowing a positive Type B pre-NDA meeting with the U.S. Food and Drug Administration in October, Taiho plans to initiate a rolling submission of an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.

oThe Company shared updated efficacy and safety data demonstrating responses in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.

oTaiho shared initial data from the REZILIENT2 cohort demonstrating the clinical activity of zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC.

oTaiho also shared initial data from the REZILIENT2 cohort demonstrating intracranial responses with zipalertinib in patients with active brain metastases at the ESMO Congress 2025.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**CLN-049 (FLT3xCD3 bispecific T cell engager):** Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

oEnrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS. The Company recently shared clinical data in a published ASH abstract and updated results will be shared in an oral presentation at the 2025 ASH Annual Meeting on December 8, 2025. CLN-049 demonstrated promising anti-leukemic activity, including a ~30% CRc rate at clinically active target doses, in a heavily pretreated population of patients, regardless of FLT3 mutational status.

oEnrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

**Third Quarter 2025 Financial Results**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Cash Position:** Cash, cash equivalents, short- and long-term investments, and interest receivable were $475.5 million as of September 30, 2025. Cullinan expects its cash resources to provide runway into 2029 under its new operating plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**R&D Expenses:** Research and development expenses were $42.0 million for the third quarter of 2025, compared to $35.5 million for the same period in 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**G&A Expenses:** General and administrative expenses were $13.6 million for the third quarter of 2025, compared to $13.3 million for the same period in 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Net Loss:** Net loss attributable to Cullinan was $50.6 million for the third quarter of 2025, compared to $40.6 million for the same period in 2024.

**About Cullinan Therapeutics** 

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow us on LinkedIn and X.

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**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company's beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for our product candidates, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our plans regarding future data presentations, our cash runway, and other statements that are not historical facts. The words "believe," "continue," "could," "estimate," "expect," "intends," "may," "plan," "potential," "project," "pursue," "will," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release 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, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared or approved on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the impacts of governmental legislation and regulations, including adverse effects from the U.S. government shutdown; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press

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release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

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**Cullinan Therapeutics, Inc.**

**Selected Condensed Consolidated Balance Sheet Data**

**(unaudited)**

**(in thousands)**

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| | | |
|:---|:---|:---|
|  | **September 30, 2025** | **December 31, 2024** |
| Cash, cash equivalents, investments, and interest receivable | $475498 | $606917 |
| Total assets | $484126 | $621824 |
| Total current liabilities | $32757 | $30647 |
| Total liabilities | $32757 | $31496 |
| Total stockholders' equity | $451369 | $590328 |

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**Cullinan Therapeutics, Inc.**

**Consolidated Statements of Operations**

**(unaudited)**

**(in thousands, except per share amounts)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended September 30,** | **Three Months Ended September 30,** | **Nine Months Ended September 30,** | **Nine Months Ended September 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $41968 | $35506 | $144457 | $102411 |
| &nbsp;&nbsp;&nbsp;General and administrative | 13627 | 13349 | 41932 | 39460 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 55595 | 48855 | 186389 | 141871 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Loss from operations | (55595) | (48855) | (186389) | (141871) |
| Other income (expense): |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Interest income | 5093 | 8384 | 17597 | 22148 |
| &nbsp;&nbsp;&nbsp;Other income (expense), net | (108) | (89) | (374) | (205) |
| Net loss | (50610) | (40560) | (169166) | (119928) |
| &nbsp;&nbsp;&nbsp;Net loss attributable to noncontrolling interests |  |  |  | (192) |
| Net loss attributable to Cullinan | $(50610) | $(40560) | $(169166) | $(119736) |
| Basic and diluted net loss per share attributable to Cullinan: |  |  |  |  |
| Common stock | $(0.77) | $(0.63) | $(2.58) | $(2.04) |
| Preferred stock | $(7.72) | $(6.26) | $(25.84) | $(20.42) |
| Weighted-average shares used in computing net loss per share attributable to Cullinan: |  |  |  |  |
| Common stock | 59075 | 58337 | 58999 | 52157 |
| Preferred stock | 648 | 648 | 648 | 648 |

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**Contacts:**

**Investors**

Nick Smith

+1 401.241.3516

nsmith@cullinantx.com

**Media** 

Rose Weldon

+1 215.801.7644

rweldon@cullinantx.com

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