Cullinan Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
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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.
Sep 30, 2025 · Filed Nov 6, 2025
CGEM$11.31+4.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0000950170-25-104551
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-268066
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 115 previous paragraphs and 118 current paragraphs.
85 unchanged; 28 reworded; 5 added; 1 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 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 (5)
Current report
Recently Discontinued Programs
Current report
U.S. Government Shutdown
Current report
During the ongoing government shutdown in the U.S., the FDA has retained the majority of its staff and continues most of its typical operations. However, during the government shutdown, the FDA is not accepting new marketing applications that require a user fee, including NDAs. Taiho intends to initiate a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins NSCLC by the end of 2025. If the government shutdown continues, acceptance and review of the NDA submission for zipalertinib may be delayed. Additionally, even when the government shutdown ends, the FDA may face a backlog of marketing submissions that it had not accepted for review during the shutdown, which may further delay acceptance and review of the planned NDA for zipalertinib.
Current report
Income Taxes
Current report
In July 2025, the U.S enacted the budget reconciliation bill H.R. 1 into law, which included significant changes to U.S. income tax laws. We have assessed the impacts of H.R. 1 in the current quarter and have determined that there is no expected impact on our 2025 effective tax rate.
Removed paragraphs (1)
Previous report
Recently Discontinued
Reworded paragraphs (28)
Previous wording
We are a clinical-stage biopharmaceutical company dedicated to creating new standards of care for patients. Our strategy is to identify high-impact targets, which we define as those that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer, and then select what we believe is the optimal therapeutic modality for those targets. We source innovation both internally and externally, focusing on product candidates with novel technology or differentiated mechanisms. Before we advance a product candidate into clinical development, we evaluate its potential for activity as a single agent as well as its ability to generate an immune response or to inhibit disease processes. Using this strategy, we have built a broad and deep pipeline of targeted immunology and oncology programs that includes multiple distinct clinical-stage product candidates.
Current wording
We are a clinical-stage biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Our strategy is to identify high-impact targets, which we define as those that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer, and then select what we believe is the optimal therapeutic modality for those targets. We source innovation both internally and externally, focusing on product candidates with novel technology or differentiated mechanisms. Before we advance a product candidate into clinical development, we evaluate its potential for activity as a single agent as well as its ability to generate an immune response or to inhibit disease processes. Using this strategy, we have built a pipeline of targeted immunology and oncology product candidates that aim to maximize therapeutic potential for patients.
Previous wording
CLN-978 is a CD19xCD3 bispecific T cell engager that we are developing for autoimmune diseases. CLN-978 is being investigated in patients with systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”) and Sjögren’s disease (“SjD”). The global Phase 1 clinical trial in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and we plan to share initial safety data and B cell depletion data from Part A of the study in the fourth quarter of 2025. The Phase 1 clinical trial in patients with active, difficult-to-treat RA is enrolling in Europe, and we plan to share initial clinical data during the first half of 2026. This company-sponsored study is being led by sites at the Friedrich-Alexander University of Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Phase 1 clinical trial in patients with active, moderate to severe SjD is ongoing in the U.S. and Europe.
Current wording
CLN-978 is a CD19xCD3 bispecific T cell engager that we are developing for autoimmune diseases. In the Phase 1 OUTRACE Program, CLN-978 is being investigated 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 moderate to severe SLE. The OUTRACE RA Study is a Phase 1 clinical trial in patients with active, difficult-to-treat RA, which is ongoing in Europe. We plan to share initial safety and B cell depletion data in SLE and RA in the first half of 2026. The OUTRACE SjD Study is an ongoing global Phase 1 clinical trial in patients with active, moderate to severe Sjögren’s disease. Separately, we were issued a 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.
Previous wording
We are evaluating zipalertinib in a pivotal Phase 2b portion of the REZILIENT1 clinical trial in patients with EGFR ex20ins non-small cell lung cancer ("NSCLC") who progressed after prior systemic therapy. In January 2025, we announced the Phase 2b portion of the REZILIENT1 trial met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The results were shared at the 2025 American Society of Clinical Oncology Annual Meeting and published simultaneously in the Journal of Clinical Oncology. We plan to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the International Association for the Study of Lung Cancer ("IASLC") 2025 World Conference on Lung Cancer ("WCLC") in September 2025. Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit a new drug application for zipalertinib in relapsed EGFR ex20ins NSCLC by the end of 2025.
Current wording
We are evaluating zipalertinib in a pivotal Phase 2b portion of the REZILIENT1 clinical trial in patients with EGFR ex20ins non-small cell lung cancer ("NSCLC") who progressed after prior systemic therapy. In January 2025, we announced the Phase 2b portion of the REZILIENT1 trial met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The results were shared at the 2025 American Society of Clinical Oncology Annual Meeting and published simultaneously in the Journal of Clinical Oncology. We also shared updated efficacy and safety data demonstrating responses in patients previously treated with amivantamab during a mini oral abstract session at the International Association for the Study of Lung Cancer ("IASLC") 2025 World Conference on Lung Cancer ("WCLC"). Following a positive Type B pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”) in October 2025, Taiho plans to initiate a rolling submission of a new drug application (“NDA”) in relapsed EGFR ex20ins NSCLC by the end of 2025.
Previous wording
Taiho is also evaluating zipalertinib in a Phase 2 parallel cohort study (“REZILIENT2”). Taiho plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC in September 2025. Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with active brain metastases at the European Society for Medical Oncology Congress 2025 in October 2025.
Current wording
Taiho is also evaluating zipalertinib in a Phase 2 parallel cohort study (“REZILIENT2”). Taiho 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. Taiho also shared initial data from the REZILIENT2 cohort demonstrating intracranial responses with zipalertinib in patients with active brain metastases at the European Society for Medical Oncology Congress 2025.
Previous wording
CLN-049 is a FLT3xCD3 bispecific T cell engager. CLN-049 is being investigated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome, and we plan to share clinical data in the fourth quarter of 2025. CLN-049 is also being evaluated in a Phase 1 clinical trial in patients with measurable minimal residual disease positive AML.
Current wording
CLN-049 is a FLT3xCD3 bispecific T cell engager. CLN-049 is being investigated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome. We recently shared clinical data in a published American Society of Hematology (“ASH”) abstract demonstrating anti-leukemic activity at clinically active target doses in patients with relapsed/refractory AML and updated results will be shared in an oral presentation at the 2025 ASH Annual Meeting in December 2025. CLN-049 is also being evaluated in a Phase 1 clinical trial in patients with AML and measurable residual disease immediately following induction therapy.
Previous wording
CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by both cytotoxic innate and adaptive immune cells. Our Phase 1 clinical trial of CLN-619 continues with the disease-specific expansion cohorts in patients with NSCLC. We also continue to evaluate CLN-619 in a Phase 1 clinical trial in patients with relapsed/refractory multiple myeloma.
Current wording
CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by both cytotoxic innate and adaptive immune cells that we were evaluating in Phase 1 clinical trials. In May 2025, following a review of the CLN-619 data from the disease-specific expansion cohorts for endometrial and cervical cancers, we announced discontinuation of further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet our internal threshold for advancement. In November 2025, after a review of the emerging clinical data in patients with NSCLC and multiple myeloma, we decided not to pursue further development of CLN-619.
Previous wording
CLN-617 is a fusion protein combining two potent antitumor cytokines, interleukin-2 and interleukin-12, with tumor retention domains for the treatment of solid tumors. CLN-617 is being investigated in a Phase 1 clinical trial in patients with advanced solid tumors.
Current wording
CLN-617 is a fusion protein combining two potent antitumor cytokines, interleukin-2 and interleukin-12, with tumor retention domains for the treatment of solid tumors that we were evaluating in a Phase 1 clinical trial. In November 2025, after a review of the emerging clinical data in patients with advanced solid tumors, we decided not to pursue further development of CLN-617.
Previous wording
We hold the worldwide intellectual property rights for CLN-978 and the worldwide, excluding mainland China, Hong Kong, Macau and Taiwan (collectively referred to as "greater China"), intellectual property rights for velinotamig. We also hold the worldwide intellectual property rights or exclusive options for worldwide intellectual property for our earlier-stage programs. We have a controlling interest in the worldwide intellectual property rights for CLN-619, CLN-049, and CLN-617. We are co-developing zipalertinib, for which Taiho holds the intellectual property rights, with an affiliate of Taiho. The following table shows our ownership interest as of June 30, 2025 in product candidates in which we have a controlling interest in the worldwide intellectual property rights:
Current wording
We hold the worldwide intellectual property rights for CLN-978 and the worldwide, excluding mainland China, Hong Kong, Macau and Taiwan (collectively referred to as "greater China"), intellectual property rights for velinotamig. We also hold the worldwide intellectual property rights or exclusive options for worldwide intellectual property for our early-stage programs. We have a controlling interest in the worldwide intellectual property rights for CLN-619, CLN-049, and CLN-617. We are co-developing zipalertinib, for which Taiho holds the intellectual property rights, with an affiliate of Taiho. The following table shows our ownership interest as of September 30, 2025 in product candidates in which we have a controlling interest in the worldwide intellectual property rights:
Previous wording
As of June 30, 2025, we had cash, cash equivalents, and short-term investments of $265.5 million, and long-term investments and interest receivable of $245.4 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, 2025, we had an accumulated deficit of $486.8 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 September 30, 2025, we had cash, cash equivalents, and short-term investments of $332.6 million, and long-term investments and interest receivable of $142.9 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 September 30, 2025, we had an accumulated deficit of $537.4 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 and Six Months Ended June 30, 2025 and 2024
Current wording
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
Previous wording
The following table presents our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table presents our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
In the fourth quarter of 2024, we began disclosing research and development personnel costs without the effect of intercompany allocations to product candidates held by our development subsidiaries and also began disclosing license agreement obligations separately from the related product candidate. We have recast prior period financial information to conform to the new presentation. The following table summarizes our research and development expenses for the three and six months ended June 30, 2025 and 2024 (in thousands):
Current wording
In the fourth quarter of 2024, we began disclosing research and development personnel costs without the effect of intercompany allocations to product candidates held by our development subsidiaries and also began disclosing license agreement obligations separately from the related product candidate. We have recast prior period financial information to conform to the new presentation. The following table summarizes our research and development expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
The $35.6 million increase in research and development expenses in the six months ended June 30, 2025 compared to the same period in 2024 was primarily due to the one-time upfront in-licensing fee for velinotamig ($20.0 million), and increases in clinical costs ($9.7 million), personnel costs relating to additional headcount ($5.6 million), equity-based compensation costs ($1.1 million), and chemistry, manufacturing and controls costs ($0.8 million), offset partially by a decrease in preclinical costs ($1.9 million).
Current wording
The $6.5 million increase in research and development expenses in the three months ended September 30, 2025 compared to the same period in 2024 was primarily due to increases in clinical development costs ($4.2 million), personnel costs relating to additional headcount ($2.0 million), and chemistry, manufacturing and controls costs ($0.8 million), offset partially by a decrease in preclinical costs ($0.5 million).
Previous wording
The $24.8 million increase in research and development expenses in the three months ended June 30, 2025 compared to the same period in 2024 was primarily due to the one-time upfront in-licensing fee for velinotamig ($20.0 million), and increases in clinical costs ($3.7 million), personnel costs relating to additional headcount ($2.3 million), equity-based compensation costs ($0.3 million), and chemistry, manufacturing and controls costs ($0.2 million), offset partially by a decrease in preclinical costs ($1.9 million).
Current wording
The $42.0 million increase in research and development expenses in the nine months ended September 30, 2025 compared to the same period in 2024 was primarily due to the one-time upfront in-licensing fee for velinotamig ($20.0 million), and increases in clinical development costs ($13.8 million), personnel costs relating to additional headcount ($7.6 million), chemistry, manufacturing and controls costs ($1.6 million), and equity-based compensation expense ($1.1 million), offset partially by a decrease in preclinical costs ($2.3 million).
Previous wording
The $1.0 million increase in general and administrative expenses in the three months ended June 30, 2025 compared to the same period in 2024 was primarily due to increases in other professional fees ($1.3 million) and legal costs ($0.9 million), partially offset by decreases in equity-based compensation costs ($1.0 million).
Current wording
The $0.3 million increase in general and administrative expenses in the three months ended September 30, 2025 compared to the same period in 2024 was primarily due to an increase in other professional fees ($0.3 million).
Previous wording
The $2.2 million increase in general and administrative expenses in the six months ended June 30, 2025 compared to the same period in 2024 was primarily due to increases in other professional fees ($1.8 million) and legal costs ($1.5 million), partially offset by decreases in personnel costs ($0.7 million) and equity-based compensation costs ($0.6 million).
Current wording
The $2.5 million increase in general and administrative expenses in the nine months ended September 30, 2025 compared to the same period in 2024 was primarily due to increases in other professional fees ($2.1 million) and legal costs ($1.4 million), partially offset by decreases in personnel costs ($0.7 million) and equity-based compensation costs ($0.5 million).
Previous wording
The $2.3 million and $1.4 million decreases in other income for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024 was primarily related to lower investment income.
Current wording
The $3.3 million and $4.7 million decreases in other income for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024 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 June 30, 2025, we had cash, cash equivalents, and short-term investments of $265.5 million, and long-term investments and interest receivable of $245.4 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 September 30, 2025, we had cash, cash equivalents, and short-term investments of $332.6 million, and long-term investments and interest receivable of $142.9 million.
Previous wording
We have an at-the-market equity offering program (the "ATM") through an agreement with Cowen and Company, LLC (“Cowen”), pursuant to which we may offer and sell up to $125.0 million of our common stock from time to time through Cowen, acting as our sales agent. We made no sales under the ATM in the six months ended June 30, 2025. Through June 30, 2025, we have sold approximately 3.3 million shares under the ATM and received net proceeds of $38.4 million, after deducting commissions. As of June 30, 2025, we had $85.6 million in shares of our common stock remaining under the ATM.
Current wording
We have an at-the-market equity offering program (the "ATM") through an agreement with Cowen and Company, LLC (“Cowen”), pursuant to which we may offer and sell up to $125.0 million of our common stock from time to time through Cowen, acting as our sales agent. We made no sales under the ATM in the nine months ended September 30, 2025. Through September 30, 2025, we have sold approximately 3.3 million shares under the ATM and received net proceeds of $38.4 million, after deducting commissions. As of September 30, 2025, we had $85.6 million in shares of our common stock remaining under the ATM.
Previous wording
Comparison of Cash Flows for the Six Months Ended June 30, 2025 and 2024
Current wording
Comparison of Cash Flows for the Nine Months Ended September 30, 2025 and 2024
Previous wording
The following table summarizes our sources and uses of cash for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous 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.
Current wording
For the nine months ended September 30, 2025, our operating activities used $137.6 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $157.4 million, partially offset by interest income, excluding accretion on marketable securities, of $12.2 million, a $5.0 million net change in our non-tax operating assets and liabilities, 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 six months ended June 30, 2024, our operating activities used $74.5 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $74.1 million and a $9.3 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $6.7 million, and a net income tax refund of $2.3 million. The non-cash operating expenses primarily consisted of equity-based compensation expense.
Current wording
For the nine months ended September 30, 2024, our operating activities used $108.7 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $113.5 million and a $7.5 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $10.2 million, and a net income tax refund of $2.3 million. The non-cash operating expenses primarily consisted of equity-based compensation expense.
Previous 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.
Current wording
For the nine months ended September 30, 2025, our investing activities provided $157.6 million of cash, which consisted of $374.6 million of proceeds from the maturities of marketable securities, partially offset by $216.9 million of purchases of marketable securities.
Previous wording
For the six months ended June 30, 2024, our investing activities used $172.2 million of cash, which primarily consisted of $456.3 million of purchases of marketable securities, partially offset by $284.1 million of proceeds from the maturities of marketable securities.
Current wording
For the nine months ended September 30, 2024, our investing activities used $152.3 million of cash, which primarily consisted of $553.1 million of purchases of marketable securities, partially offset by $400.8 million of proceeds from the maturities of marketable securities.
Previous 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 equity-based compensation plans.
Current wording
For the nine months ended September 30, 2025, our financing activities provided $0.3 million of cash, which consisted of net proceeds from the issuance of common stock under equity-based compensation plans.
Previous wording
For the six months ended June 30, 2024, our financing activities provided $263.3 million of cash, which primarily consisted of $262.7 million of net proceeds from the issuance of common stock under a private placement and $4.4 million in net proceeds from the issuance of common stock under equity-based compensation plans, partially offset by $3.8 million paid to acquire shares of our CLN-619 development subsidiary that were held by noncontrolling interests.
Current wording
For the nine months ended September 30, 2024, our financing activities provided $264.6 million of cash, which consisted of $262.7 million of net proceeds from the issuance of common stock under a private placement and $6.4 million in net proceeds from the issuance of common stock under equity-based compensation plans, partially offset by $4.4 million paid to acquire shares of our CLN-619 development subsidiary that were held by noncontrolling interests.
Previous wording
As of June 30, 2025, total future minimum lease payments were $1.6 million with $1.5 million payable within twelve months. See Note 10 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 September 30, 2025, total future minimum lease payments of $1.2 million were all payable within twelve months. See Note 10 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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
In May 2025, following a review of the CLN-619 data from the disease-specific expansion cohorts for endometrial and cervical cancers, we announced discontinuation of further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet our internal threshold for advancement.