Cullinan Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001193125-26-210304
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-336717
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 108 previous paragraphs and 106 current paragraphs.
72 unchanged; 24 reworded; 8 added; 9 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
Immunology Pipeline
Current report
Oncology Pipeline
Current report
The $16.6 million decrease in research and development expenses in the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to a one-time upfront in-licensing fee for velinotamig ($20.0 million) paid in 2025, and decreases in chemistry, manufacturing and controls ("CMC") costs ($0.5 million), and personnel related costs ($0.5 million), offset partially by increases in clinical development costs ($4.4 million), and preclinical costs ($0.4 million).
Current report
The $15.9 million decrease in research and development expenses in the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to a one-time upfront in-licensing fee for velinotamig ($20.0 million) paid in 2025, and decreases in CMC costs ($0.4 million), and personnel related costs ($0.4 million), offset partially by increases in clinical development costs ($5.2 million).
Current report
The following table summarizes our general and administrative expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):
Current report
The $3.9 million decrease in general and administrative expenses in the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to decreases in equity-based compensation costs of $3.4 million, legal costs of $0.6 million, and other professional service costs of $0.3 million, partially offset by an increase in personnel related costs of $0.6 million.
Current report
The following table summarizes our other income for the three and six months ended June 30, 2026 and 2025 (in thousands):
Current report
Recently Issued Accounting Pronouncements
Removed paragraphs (9)
Previous report
Immunology
Previous report
Oncology
Previous report
o
Previous report
o
Previous report
o
Previous report
The following table presents our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):
Previous report
The $0.7 million increase in research and development expenses in the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to increases in clinical development costs of $0.8 million.
Previous report
For the three months ended March 31, 2025, no cash was provided by or used in financing activities.
Previous report
Recently Issued and Adopted Accounting Pronouncements
Reworded paragraphs (24)
Previous wording
We are a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. We pursue 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, we are advancing our mission to deliver new standards of care for patients.
Current wording
We are a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. We pursue promising therapeutic targets while leveraging our 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, we are advancing our mission to deliver new standards of care for patients.
Previous wording
CLN-978 is a CD19xCD3 T cell engager that we are developing for autoimmune diseases. In the Phase 1 OUTRACE Program, CLN-978 is being evaluated in patients with systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”), and Sjögren’s disease (“SjD”). The OUTRACE SLE Study is an ongoing global Phase 1 clinical trial in patients with treatment-refractory moderate to severe SLE. The OUTRACE RA Study is a Phase 1 clinical trial in patients with difficult-to-treat RA, which is ongoing in Europe. We plan to share initial clinical data in SLE and RA in a poster presentation at the European Alliance of Associations for Rheumatology (“EULAR”) European Congress of Rheumatology in June 2026. We also plan to share multi-dose regimen data in RA in the third quarter of 2026. The OUTRACE SjD Study is an ongoing global Phase 1 clinical trial in patients with treatment-refractory moderate to severe Sjögren’s disease. We plan to share initial clinical data in Sjögren’s disease in the fourth quarter of 2026.
Current wording
CLN-978 is a CD19xCD3 T cell engager that we are developing for rheumatic diseases driven by pathogenic B cells. In the Phase 1 OUTRACE Program, CLN-978 is being evaluated in patients with systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”), and Sjögren’s disease (“SjD”). The OUTRACE SLE Study is an ongoing global Phase 1 clinical trial in patients with treatment-refractory moderate to severe SLE. The OUTRACE RA Study is a Phase 1 clinical trial in patients with difficult-to-treat RA, which is ongoing in Europe. We shared initial clinical data in patients with SLE and RA in a poster presentation at the European Alliance of Associations for Rheumatology (“EULAR”) European Congress of Rheumatology and additional clinical data, including initial multi-dose regimen data in patients with RA, at an investor event in June 2026. We also plan to share additional multi-dose regimen data in patients with RA and SLE in the third and fourth quarters of 2026, respectively, and expect to begin Phase 2 expansion in both disease areas by early 2027. The OUTRACE SjD Study is an ongoing global Phase 1 clinical trial in patients with treatment-refractory moderate to severe Sjögren’s disease. We plan to share initial clinical data in patients with Sjögren’s disease in the fourth quarter of 2026.
Previous wording
Velinotamig is a BCMAxCD3 T cell engager that we are developing for autoimmune diseases. Chongqing Genrix Biopharmaceutical Co., Ltd. ("Genrix"), from which we licensed velinotamig, is enrolling a Phase 1 clinical trial in China in patients with treatment-refractory autoimmune diseases, starting with moderate to severe SLE and to be followed by planned expansion into other indications, and initial multi-dose regimen data from the dose escalation phase in patients with SLE will be shared in the fourth quarter of 2026. We intend to use the data generated from this Phase 1 clinical trial to accelerate global clinical development.
Current wording
Velinotamig is a BCMAxCD3 T cell engager that we are developing for autoimmune diseases driven by pathogenic autoantibodies produced by long-lived plasma cells. Chongqing Genrix Biopharmaceutical Co., Ltd. ("Genrix"), from which we licensed velinotamig, is enrolling a Phase 1/2 clinical trial in China in patients with treatment-refractory autoimmune diseases, initially in patients with moderate to severe SLE. In June 2026, we shared initial clinical observations from two SLE patients with nephritis from the trial. Additional multi-dose regimen data from the trial are expected to be shared in the fourth quarter of 2026. In early 2027, we plan to initiate a global Phase 1/2 basket clinical trial in patients with autoimmune cytopenias, including immune thrombocytopenia and autoimmune hemolytic anemia.
Previous wording
CLN-049 is a FLT3xCD3 T cell engager. CLN-049 is being evaluated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome (“MDS”). At the 2025 American Society for Hematology (“ASH”) Annual Meeting, we shared monotherapy efficacy data from the ongoing dose escalation portion of the trial in a heavily pretreated all-comer population of patients with relapsed/refractory AML. We plan to share a clinical data update from the dose escalation portion of the trial in the second half of 2026. Dose level expansion continues in order to determine the recommended Phase 2 dose by the fourth quarter of 2026 for a potential single-arm pivotal registrational trial.
Current wording
CLN-049 is a FLT3xCD3 T cell engager that we are developing for blood cancers. CLN-049 is being evaluated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome (“MDS”). We plan to share a clinical data update from the dose escalation portion of the trial in the fourth quarter of 2026. Following a positive End-of-Phase 1 meeting with the U.S. Food and Drug Administration (“U.S. FDA”) in July 2026, we will initiate a potentially registrational Phase 2 trial in patients with relapsed/refractory AML in the third quarter of 2026. The study will begin with a dose-optimization phase with seamless progression to a single-arm expansion cohort at the recommended Phase 2 dose. Phase 2 expansion will include a parallel exploratory cohort enrolling previously untreated TP53-mutated AML patients. In the fourth quarter of 2026, we also will initiate a Phase 1/2 clinical trial evaluating the combination of CLN-049, venetoclax, and azacitidine as a potential frontline treatment for patients with previously untreated AML.
Previous wording
Zipalertinib (CLN-081/TAS6417), on which we are collaborating with an affiliate of Taiho Pharmaceutical Co., Ltd. ("Taiho"), is an orally-available small-molecule, irreversible epidermal growth factor receptor ("EGFR") inhibitor that is designed to selectively target cells expressing EGFR exon 20 insertion mutations (“EGFR ex20ins”) with relative sparing of cells expressing wild-type EGFR.
Current wording
Zipalertinib (CLN-081/TAS6417), on which we are collaborating with an affiliate of Taiho Pharmaceutical Co., Ltd. ("Taiho"), is an orally-available small-molecule, irreversible epidermal growth factor receptor ("EGFR") inhibitor that is designed to selectively target cells expressing EGFR exon 20 insertion mutations (“EGFR ex20ins”) with relative sparing of cells expressing wild-type EGFR. In April 2026, the U.S. FDA accepted for review a new drug application (“NDA”) for zipalertinib, supported by data from the pivotal Phase 2b portion of the REZILIENT1 clinical trial, for the treatment of patients with locally advanced or metastatic EGFR ex20ins non-small cell lung cancer (“NSCLC”) whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The U.S. FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027. Taiho is also evaluating zipalertinib in a Phase 2 parallel cohort trial (“REZILIENT2”) and a global Phase 3 clinical trial (“REZILIENT3”) in combination with chemotherapy as a potential first-line treatment for locally advanced or metastatic EGFR ex20ins NSCLC adult patients, for which Taiho completed enrollment in February 2026 and expects top-line results by the end of 2026.
Previous wording
We hold the worldwide intellectual property rights for CLN-978. We hold the worldwide, excluding mainland China, Hong Kong, Macau and Taiwan (collectively referred to as “greater China”), intellectual property rights for velinotamig. We hold the worldwide intellectual property rights for CLN-049 through a development subsidiary in which we had a 98% ownership interest as of March 31, 2026. We are co-developing zipalertinib, for which Taiho holds the intellectual property rights, with an affiliate of Taiho.
Current wording
We hold worldwide intellectual property rights for CLN-978. We hold worldwide, excluding mainland China, Hong Kong, Macau and Taiwan (collectively referred to as “greater China”), intellectual property rights for velinotamig. We hold worldwide intellectual property rights for CLN-049 through a development subsidiary in which we had a 98% ownership interest as of June 30, 2026. We are co-developing zipalertinib, for which Taiho holds intellectual property rights, with an affiliate of Taiho.
Previous wording
We have funded our operations primarily through the sale of equity securities and from licensing or selling the rights to our product candidates. As of March 31, 2026, we have received net proceeds of $842.2 million from equity financings. We have received $275.0 million in revenue from a previous license agreement and cash proceeds of $18.9 million from the sale of our equity interest in our former zipalertinib development subsidiary to Taiho.
Current wording
We have funded our operations primarily through the sale of equity securities and from licensing or selling the rights to our product candidates. As of June 30, 2026, we have received net proceeds of $842.2 million from equity financings. We have received $18.9 million in revenue from a previous license agreement and cash proceeds of $275.0 million from the sale of our equity interest in our former zipalertinib development subsidiary to Taiho.
Previous wording
In April 2026, we entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) to establish an at-the-market equity offering program, pursuant to which we can offer and sell up to $200.0 million of our common stock through TD Cowen at prevailing market prices from time to time.
Current wording
In April 2026, we entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) to continue our at-the-market equity offering program (“ATM”), pursuant to which we can offer and sell up to $200.0 million of our common stock through TD Cowen at prevailing market prices from time to time. We made no sales under the ATM through June 30, 2026.
Previous wording
As of March 31, 2026, we had cash, cash equivalents, and short-term investments of $351.9 million, and long-term investments and interest receivable of $41.4 million. Interest receivable is included in prepaid expenses and other current assets on the consolidated balance sheets and represents accrued and unpaid interest on our marketable securities. We have a history of significant operating losses and have had negative cash flows from operations since our inception. As of March 31, 2026, we had an accumulated deficit of $637.8 million. We expect to continue to generate operating losses for the foreseeable future. Our future viability is dependent on the success of our research and development and our ability to access additional capital to fund our operations. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.
Current wording
As of June 30, 2026, we had cash, cash equivalents, and short-term investments of $334.5 million, and long-term investments and interest receivable of $21.4 million. Interest receivable is included in prepaid expenses and other current assets on the consolidated balance sheets and represents accrued and unpaid interest on our marketable securities. We have a history of significant operating losses and have had negative cash flows from operations since our inception. As of June 30, 2026, we had an accumulated deficit of $691.5 million. We expect to continue to generate operating losses for the foreseeable future. Our future viability is dependent on the success of our research and development and our ability to access additional capital to fund our operations. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.
Previous wording
Comparison of the Three Months Ended March 31, 2026 and 2025
Current wording
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Previous wording
The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our research and development expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):
Previous wording
The $2.0 million decrease in general and administrative expenses in the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to a decrease in equity-based compensation costs of $1.8 million.
Current wording
The $2.0 million decrease in general and administrative expenses in the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to decreases in equity-based compensation costs of $1.6 million, other professional service costs of $0.3 million, and legal costs of $0.3 million, partially offset by an increase in personnel related costs of $0.3 million.
Previous wording
The $2.5 million decrease in other income for the three months ended March 31, 2026, compared to the same period in 2025 was primarily related to lower investment income.
Current wording
The $2.2 million and $4.7 million decreases in other income for the three and six months ended June 30, 2026, compared to the same period in 2025 were primarily related to lower investment income.
Previous wording
We have a history of significant operating losses and have had negative cash flows from operations since our inception and expect to continue to generate operating losses for the foreseeable future. We have not yet commercialized any products, and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from the sale of equity securities and from licensing or selling the rights to our product candidates. As of March 31, 2026, we had cash, cash equivalents, and short-term investments of $351.9 million, and long-term investments and interest receivable of $41.4 million.
Current wording
We have a history of significant operating losses and have had negative cash flows from operations since our inception and expect to continue to generate operating losses for the foreseeable future. We have not yet commercialized any products, and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from the sale of equity securities and from licensing or selling the rights to our product candidates. As of June 30, 2026, we had cash, cash equivalents, and short-term investments of $334.5 million, and long-term investments and interest receivable of $21.4 million.
Previous wording
Based on our current operational plans and assumptions, we expect that our current cash, cash equivalents, investments, and interest receivable will be sufficient to fund operations through at least twelve months from the date of issuance of our consolidated financial statements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We cannot guarantee that we will be able to raise additional capital on reasonable terms or at all.
Current wording
Based on our current operating plans and assumptions, we expect that our current cash, cash equivalents, investments, and interest receivable will be sufficient to fund operations through at least twelve months from the date of issuance of our consolidated financial statements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We cannot guarantee that we will be able to raise additional capital on reasonable terms or at all.
Previous wording
Comparison of Cash Flows for the Three Months Ended March 31, 2026 and 2025
Current wording
Comparison of Cash Flows for the Six Months Ended June 30, 2026 and 2025
Previous wording
The following table summarizes our sources and uses of cash for the three months ended March 31, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our sources and uses of cash for the six months ended June 30, 2026 and 2025 (in thousands):
Previous wording
For the three months ended March 31, 2026, our operating activities used $46.0 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $46.0 million, and a $3.3 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $3.3 million. The non-cash operating expenses primarily consisted of equity-based compensation expense.
Current wording
For the six months ended June 30, 2026, our operating activities used $84.3 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $94.7 million, partially offset by interest income, excluding accretion on marketable securities, of $6.4 million, and a $4.2 million net change in our non-tax operating assets and liabilities. The non-cash operating expenses primarily consisted of equity-based compensation expense.
Previous wording
For the three months ended March 31, 2025, our operating activities used $43.2 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $45.5 million and a $1.8 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $4.3 million. The non-cash operating expenses primarily consisted of equity-based compensation expense.
Current wording
For the six months ended June 30, 2025, our operating activities used $100.8 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $111.4 million and a $0.6 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $8.5 million, and an income tax refund of $3.0 million related to the utilization of federal research and development credits generated during 2023 that were carried back to tax year 2022. The non-cash operating expenses primarily consisted of equity-based compensation expense.
Previous wording
For the three months ended March 31, 2026, our investing activities provided $32.4 million of cash, which consisted of $52.5 million of proceeds from the maturities of marketable securities, partially offset by $20.1 million of purchases of marketable securities.
Current wording
For the six months ended June 30, 2026, our investing activities provided $73.1 million of cash, which consisted of $107.8 million of proceeds from the maturities of marketable securities, partially offset by $34.7 million of purchases of marketable securities.
Previous wording
For the three months ended March 31, 2025, our investing activities provided $36.8 million, which consisted of $162.6 million of proceeds from the maturities of marketable securities, partially offset by $125.8 million of purchases of marketable securities.
Current wording
For the six months ended June 30, 2025, our investing activities provided $90.2 million of cash, which consisted of $294.6 million of proceeds from the maturities of marketable securities, partially offset by $204.4 million of purchases of marketable securities.
Previous wording
For the three months ended March 31, 2026, our financing activities provided $0.4 million of cash, which consisted of net proceeds from the issuance of common stock under equity-based compensation plans.
Current wording
For the six months ended June 30, 2025, our financing activities provided $0.4 million of cash, which consisted of net proceeds from the issuance of common stock under our equity-based compensation plans.
Previous wording
As of March 31, 2026, total future minimum lease payments of $2.8 million, with $1.0 million payable within twelve months. See Note 9 to our consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail on our lease obligations and the timing of expected future payments.
Current wording
As of June 30, 2026, we had total future minimum lease payments of $2.4 million, of which $0.9 million were payable within twelve months. See Note 9 to our consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail on our lease obligations and the timing of expected future payments.
Previous wording
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 of our consolidated financial statements included in this Quarterly Report on Form 10-Q.
Current wording
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 of our consolidated financial statements included in this Quarterly Report on Form 10-Q.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
In April 2026, we entered into a sales agreement with TD Cowen to continue our ATM, pursuant to which we can offer and sell up to $200.0 million of our common stock through TD Cowen at prevailing market prices from time to time. We made no sales under the ATM through June 30, 2026.
Current report — wording carried from elsewhere
For the six months ended June 30, 2026, our financing activities provided $1.5 million of cash, which consisted of net proceeds from the issuance of common stock under our equity-based compensation plans.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
In April 2026, the United States Food and Drug Administration (“U.S. FDA”) accepted a new drug application (“NDA”) for zipalertinib for the treatment of patients with locally advanced or metastatic EGFR ex20ins non-small cell lung cancer (“NSCLC”) whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is February 27, 2027. The NDA is supported by data from the pivotal Phase 2b portion of the REZILIENT1 clinical trial.
Previous report — wording carried elsewhere
Taiho is evaluating zipalertinib in a global Phase 3 clinical trial (“REZILIENT3”) in combination with chemotherapy as a potential first-line treatment for locally advanced or metastatic EGFR ex20ins NSCLC adult patients. Taiho completed enrollment of the trial in February 2026 and expects to obtain top-line results by the end of 2026.
Previous report — wording carried elsewhere
Taiho is also evaluating zipalertinib in a Phase 2 parallel cohort trial (“REZILIENT2”). Taiho shared emerging data from certain REZILIENT2 cohorts at medical conferences in 2025.