8-K
Cullinan Therapeutics, Inc. (CGEM)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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): January 08, 2026 |
|---|
CULLINAN THERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-39856 | 81-3879991 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| One Main Street<br><br>Suite 1350 | ||
| Cambridge, Massachusetts | 02142 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: 617 410-4650 | ||
| --- |
(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:
☐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:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.0001 par value per share | CGEM | The Nasdaq Global Select Market |
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.
As of December 31, 2025, Cullinan Therapeutics, Inc.'s (the "Company's") unaudited cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million. Consistent with prior guidance, the Company expects its cash resources to provide runway into 2029 based on its current operating plan.
The Company has not yet completed its quarter-end financial close process for the quarter ended December 31, 2025. The Company's cash, cash equivalents, short- and long-term investments, and interest receivable reflected above is preliminary, has not been audited and is subject to change upon completion of the Company's financial statement closing procedures. Additional information and disclosure would be required for a more complete understanding of the Company's financial position and results of operations as of and for the year ended December 31, 2025. The Company's independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to the preliminary financial data and, accordingly, does not express an opinion or provide any other form of assurance about it.
The information contained in this Current Report on Form 8-K under Item 2.02 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and will not be incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, unless specifically identified as being incorporated therein by reference.
Item 7.01 Regulation FD Disclosure.
On January 8, 2026, the Company issued a press release providing a corporate update and anticipated milestones for 2026. 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 Current Report on Form 8-K furnished pursuant to Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed to be "filed" for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any filing by the Company under the Securities Act or the Exchange Act, unless specifically identified as being incorporated therein by reference.
Item 8.01 Other Events.
On January 8, 2026, the Company provided an update on the anticipated program milestones for 2026 as set out below.
Immunology
CLN-978
- In the Company's Phase 1 OUTRACE study in patients with active, difficult-to-treat rheumatoid arthritis, dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed. In the second quarter of 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data. In the third quarter of 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
- In the Company's Phase 1 OUTRACE study in patients with moderate to severe systemic lupus erythematosus, dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed. In the second quarter of 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, additional biomarker data, and preliminary clinical activity data.
- In the Company's Phase 1 OUTRACE study in patients with active, moderate to severe Sjögren's disease, the Company has initiated patient dosing and enrollment is ongoing in the 10-microgram dose cohort. In the fourth quarter of 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
Velinotamig
- In December 2025, Chongqing Genrix Biopharmaceutical Co., Ltd. ("Genrix") initiated a Phase 1 study in China in patients with autoimmune diseases and initial clinical data from the study will be shared in the fourth quarter of 2026. The Company intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology
CLN-049
- In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory acute myeloid leukemia ("AML") from the United States Food and Drug Administration and, in an oral presentation at the 2025 ASH Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer population of patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of the study in the second half of 2026.
- In the second quarter of 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In the fourth quarter of 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose for an expected single arm pivotal registrational trial. Also in the fourth quarter of 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML. Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease immediately following induction therapy.
Zipalertinib
- We are co-developing zipalertinib with an affiliate of Taiho Pharmaceutical Co., Ltd. ("Taiho") and in November 2025, Taiho initiated a rolling submission of a new drug application ("NDA") seeking accelerated approval of zipalertinib for the treatment of patients with relapsed EGFR ex20ins NSCLC. Taiho expects completion of the NDA submission in the first quarter of 2026. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in frontline EGFR ex20ins NSCLC in the first half of 2026. The Company is eligible to receive up to $130.0 million in payments for United States regulatory milestones and 50% of any future pre-tax profits from potential United States sales of zipalertinib.
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 preliminary estimates of cash, cash equivalents, short- and long-term investments, and interest receivable as of December 31, 2025. Forward-looking statements are typically, but not always, identified by the use of words such as “estimate,” “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, the preliminary cash position reported herein reflects information available to the Company only at this time and may differ from the Company's actual cash position as of December 31, 2025, including in connection with the Company’s completion of financial closing procedures, 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)
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release issued by Cullinan Therapeutics, Inc. on January 8, 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: | January 8, 2026 | By: | /s/ Mary Kay Fenton |
| Mary Kay Fenton<br>Chief Financial Officer |
EX-99.1
Exhibit 99.1
Cullinan Therapeutics Provides Corporate Update and Highlights Anticipated 2026 Milestones
Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data
Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose for CLN-049 pivotal registrational study and initiate combination study in frontline AML in Q4 2026
Zipalertinib rolling NDA submission expected to be complete in Q1 2026 and full enrollment of REZILIENT3 frontline study expected in H1 2026
Preliminary cash and investments of $439.0 million as of December 31, 2025; Runway into 2029
CAMBRIDGE, Mass. January 8, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today provided a corporate update and shared anticipated business highlights for 2026.
“We have built strong momentum with CLN-978 and are pleased to share that we have completed multiple dose cohorts in our OUTRACE RA and OUTRACE SLE studies, and we have initiated dosing in our Sjögren’s disease study. This significant progress positions us to deliver the first company sponsored data with a CD19 T cell engager in autoimmune diseases. Throughout 2026, we will deliver data across all three indications, including important repeat dosing data in rheumatoid arthritis,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics.
“Our CLN-049 program continues to advance following the presentation of compelling efficacy and favorable safety data at ASH 2025, which we believe enables an accelerated approval pathway. We plan to complete dose expansion in relapsed/refractory AML and TP53m AML to rapidly determine a recommended Phase 2 dose, while also initiating a frontline combination study this year. Additionally, 2026 marks a pivotal milestone for zipalertinib, as Taiho completes the rolling NDA submission in the beginning of the year, and completes enrollment in the frontline study REZILIENT3 in the first half of 2026. In summary, we are focused on generating multiple catalysts for our two high-priority T cell engager programs, CLN-978 and CLN-049, positioning us for a transformative year ahead.”
Portfolio Highlights and Anticipated 2026 Milestones
Immunology
CLN-978 (CD19xCD3 bispecific T cell engager): Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjögren’s disease (SjD)
OUTRACE RA
Dose escalation is ongoing, and patients are currently being enrolled to the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
OUTRACE SLE
Dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, additional biomarker data, and preliminary clinical activity data.
OUTRACE SjD
The Company has initiated patient dosing, and enrollment is ongoing in the 10-microgram dose cohort.
In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
In December 2025, Genrix Bio initiated a Phase 1 study in China in patients with autoimmune diseases, and initial clinical data from the study will be shared in Q4 2026. 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
CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory AML from the U.S. FDA and, in an oral presentation at the 2025 ASH Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer population of patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of the study in H2 2026.
In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial.
In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
In November 2025, Taiho initiated a rolling submission of an NDA seeking accelerated approval of zipalertinib for the treatment of patients with relapsed EGFR ex20ins NSCLC. Taiho expects completion of the NDA submission in Q1 2026.
Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in H1 2026.
Cullinan is eligible to receive up to $130 million in payments for U.S. regulatory milestones and a 50/50 profit share in the U.S.
Cash Position and Cash Runway
Unaudited preliminary cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Consistent with prior guidance, Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.
The Company expects to report its fourth quarter and full-year 2025 financial results in late February 2026 which will contain additional information required for a more complete understanding of the Company’s financial position and results of operations as of and for the year ended December 31, 2025.
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 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 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 preliminary estimates of cash, cash equivalents, short- and long-term investments, and interest receivable as of December 31, 2025, 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: the preliminary cash position reported herein reflects information available to us only at this time and may differ from our actual cash position as of December 31, 2025,
including in connection with the completion of our financial statement closing procedures; 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 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.
Contacts:
Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com