CGEM 8-K
Cullinan Therapeutics, Inc. (CGEM)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
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:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 6, 2026, Cullinan Therapeutics, Inc. (the "Company") announced its financial results for the three and six months ended June 30, 2026. 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 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
|
Description |
99.1 |
|
Press release issued by Cullinan Therapeutics, Inc. on August 6, 2026, furnished herewith |
104 |
|
Cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
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: |
August 6, 2026 |
By: |
/s/ Mary Kay Fenton |
|
|
|
Mary Kay Fenton |
Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results
CLN-978 (CD19 TCE) multi-dose regimen data in RA in Q3 2026 and SLE in Q4 2026; Phase 2 expansion studies to begin early 2027
Velinotamig (BCMA TCE) multi-dose regimen data in SLE in Q4 2026; Phase 1/2 basket study in autoimmune cytopenias to begin early 2027
CLN-049 (FLT3 TCE) potentially registrational Phase 2 study in R/R AML to begin in Q3 2026
Cash and investments of $356 million as of June 30, 2026; runway into 2029
CAMBRIDGE, Mass. August 6, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2026.
“At our recent Immunology Day event, we shared compelling initial clinical data for CLN-978 and velinotamig, two T cell engagers with potential to achieve immune reset and transform outcomes for people living with autoimmune diseases. We look forward to sharing additional clinical data throughout the remainder of 2026 as we rapidly advance these programs towards Phase 2 studies,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics.
“Additionally, following a positive End-of-Phase 1 meeting with the FDA in July, we will begin a potentially registrational Phase 2 study in patients with relapsed or refractory AML this quarter. CLN-049 represents a promising novel immunotherapeutic approach for a broad population of AML patients who currently have limited treatment options and poor prognosis. With our leadership position in the T cell engager space, we are quickly advancing a differentiated pipeline across immunology and oncology to late-stage development. Together with multiple upcoming catalysts, the company is very well-positioned for significant value creation.”
Portfolio Highlights and 2026 Milestones
Immunology
Oncology
Second Quarter 2026 Financial Results
About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers 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 Cullinan on LinkedIn and X.
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 clinical development plans and anticipated 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 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 trials will not be predictive of future results in connection with future studies or clinical trials; 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 release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.
Cullinan Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||
Cash, cash equivalents, investments, and interest receivable |
|
$ |
355,967 |
|
|
$ |
438,960 |
|
Total assets |
|
$ |
363,787 |
|
|
$ |
448,374 |
|
Total current liabilities |
|
$ |
40,628 |
|
|
$ |
37,741 |
|
Total liabilities |
|
$ |
42,033 |
|
|
$ |
39,644 |
|
Total stockholders’ equity |
|
$ |
321,754 |
|
|
$ |
408,730 |
|
Cullinan Therapeutics, Inc.
Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
44,437 |
|
|
$ |
61,030 |
|
|
$ |
86,560 |
|
|
$ |
102,489 |
|
General and administrative |
|
|
12,817 |
|
|
|
14,768 |
|
|
|
24,391 |
|
|
|
28,305 |
|
Total operating expenses |
|
|
57,254 |
|
|
|
75,798 |
|
|
|
110,951 |
|
|
|
130,794 |
|
Loss from operations |
|
|
(57,254 |
) |
|
|
(75,798 |
) |
|
|
(110,951 |
) |
|
|
(130,794 |
) |
Interest income |
|
|
3,648 |
|
|
|
5,924 |
|
|
|
7,746 |
|
|
|
12,504 |
|
Other expense, net |
|
|
(98 |
) |
|
|
(181 |
) |
|
|
(160 |
) |
|
|
(266 |
) |
Net loss |
|
$ |
(53,704 |
) |
|
$ |
(70,055 |
) |
|
$ |
(103,365 |
) |
|
$ |
(118,556 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock |
|
$ |
(0.81 |
) |
|
$ |
(1.07 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.81 |
) |
Preferred stock |
|
$ |
(8.10 |
) |
|
$ |
(10.70 |
) |
|
$ |
(15.63 |
) |
|
$ |
(18.12 |
) |
Weighted-average shares used in computing basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock |
|
|
61,493 |
|
|
|
59,015 |
|
|
|
60,980 |
|
|
|
58,960 |
|
Preferred stock |
|
|
479 |
|
|
|
648 |
|
|
|
517 |
|
|
|
648 |
|
Contacts:
Investors
Nick Smith
+1 401.241.3516
Media
Rose Weldon
+1 215.801.7644