Cullinan Therapeutics, Inc.

Previous 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.

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. The OUTRACE SjD Study is an ongoing global Phase 1 clinical trial in patients with treatment-refractory moderate to severe Sjögren’s disease. 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. In December 2026, we plan to share single target dose data in SLE, RA and SjD. The update is expected to include initial data in patients with SjD as well as updated data with longer follow-up for responding SLE and RA patients. We also plan to share multi-dose regimen data across SLE, RA, and SjD, with a focus on initial clinical activity, biomarker data, and safety.

Previous 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.

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. In October 2026, following an Investigational New Drug Application clearance by the U.S. Food and Drug Administration (“U.S. FDA”) and Human Research Ethics Committee clearance in Australia, we initiated a global Phase 1/2 basket clinical trial in patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia. 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. At the American College of Rheumatology Convergence 2026, clinical data in patients with SLE were shared in a poster presentation. The data are expected to further inform development of the BCMA-directed therapy across autoimmune diseases.

Previous 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.

Current wording

CLN-049 is a FLT3xCD3 T cell engager that we are developing for blood cancers. CLN-049 is being evaluated in clinical trials for patients with acute myeloid leukemia ("AML") or myelodysplastic syndrome (“MDS”). In a published American Society of Hematology (“ASH”) abstract, we shared updated clinical data from the Phase 1 dose escalation study in patients with relapsed/refractory AML or MDS. The dose escalation results will be further detailed in a poster presentation at the 2026 ASH Annual Meeting in December 2026. In October 2026, we initiated a potentially registrational Phase 2 clinical trial in patients with relapsed/refractory AML. As aligned with the U.S. FDA after a positive End-of-Phase 1 meeting in July 2026, the study incorporates a dose-optimization phase evaluating two target dose levels of CLN-049, followed by seamless advancement to a single-arm expansion cohort at the recommended Phase 2 dose. In November 2026, we also initiated a Phase 1/2 clinical trial evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with newly diagnosed 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. 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.

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. Zipalertinib is being evaluated in the REZILIENT Program across various patient settings of EGFR-mutated non-small cell lung cancer (“NSCLC”), including in patients with EGFR exon 20 insertion mutations (“ex20ins”) and other uncommon EGFR mutations. The global Phase 3 clinical trial ("REZILIENT3") evaluating zipalertinib in combination with platinum-based chemotherapy as a potential first-line treatment for locally advanced or metastatic EGFR ex20ins NSCLC adult patients met its primary endpoint at interim analysis. Zipalertinib combination therapy demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival compared to chemotherapy alone. These results were presented at the International Association for the Study of Lung Cancer's 2026 World Conference on Lung Cancer. In October 2026, based on the REZILIENT3 data, a New Drug Application (“NDA”) submission was initiated under the U.S. FDA's Real-Time Oncology Review program for zipalertinib in combination with platinum-based chemotherapy for the treatment of patients with previously untreated, locally advanced or metastatic EGFR ex20ins NSCLC. We expect to complete the NDA submission in November. Zipalertinib also holds Breakthrough Therapy designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy. Supported by data from the pivotal Phase 2b portion of the REZILIENT1 clinical trial, an NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under U.S. FDA review, with 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 new clinical data demonstrating the intracranial antitumor activity of zipalertinib monotherapy in patients with NSCLC with EGFR ex20ins or uncommon EGFR mutations and active brain metastases were presented in a poster session at the European Society for Medical Oncology Congress 2026.

Previous 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.

Current wording

As of September 30, 2026, we had cash, cash equivalents, and short-term investments of $289.6 million, and long-term investments and interest receivable of $24.2 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, 2026, we had an accumulated deficit of $740.9 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

We are subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on third parties, compliance with government regulations and the ability to obtain additional capital to fund operations. Our current and future product candidates will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require additional capital, adequate personnel and extensive compliance-reporting capabilities. There can be no assurance that our research and development will be successfully completed, that adequate protection for our intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable.

Current wording

We are subject to risks and uncertainties common to clinical stage companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on third parties, compliance with government regulations and the ability to obtain additional capital to fund operations. Our current and future product candidates will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require additional capital, adequate personnel and extensive compliance-reporting capabilities. There can be no assurance that our research and development will be successfully completed, that adequate protection for our intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of the Three and Nine Months Ended September 30, 2026 and 2025

Previous wording

The following table summarizes our research and development expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

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 wording

The $1.8 million decrease in research and development expenses in the three months ended September 30, 2026 compared to the same period in 2025 was primarily due to decreases in chemistry, manufacturing and controls ("CMC") costs ($1.5 million), preclinical costs ($1.2 million), and personnel related costs ($0.5 million), offset partially by increases in clinical development costs ($1.4 million).

Previous wording

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 wording

The $17.7 million decrease in research and development expenses in the nine months ended September 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 ($1.9 million), personnel related costs ($0.9 million), and preclinical costs ($0.9 million), offset partially by increases in clinical development costs ($6.6 million).

Previous wording

The following table summarizes our general and administrative expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our general and administrative expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

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 wording

The $1.2 million decrease in general and administrative expenses in the three months ended September 30, 2026 compared to the same period in 2025 was primarily due to a decrease in equity-based compensation costs ($1.4 million).

Previous 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.

Current wording

The $5.1 million decrease in general and administrative expenses in the nine months ended September 30, 2026 compared to the same period in 2025 was primarily due to decreases in equity-based compensation costs ($4.8 million), legal costs ($0.5 million), and other professional service costs ($0.4 million), partially offset by an increase in personnel related costs ($0.7 million).

Previous wording

The following table summarizes our other income for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our other income for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous 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.

Current wording

The $1.8 million and $6.4 million decreases in other income for the three and nine months ended September 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 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.

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 do not have any products approved for sale and have not generated any revenue from product sales. 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, 2026, we had cash, cash equivalents, and short-term investments of $289.6 million, and long-term investments and interest receivable of $24.2 million.

Previous wording

Comparison of Cash Flows for the Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of Cash Flows for the Nine Months Ended September 30, 2026 and 2025

Previous wording

The following table summarizes our sources and uses of cash for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our sources and uses of cash for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous 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.

Current wording

For the nine months ended September 30, 2026, our operating activities used $127.3 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $138.9 million, partially offset by interest income, excluding accretion of discount on marketable securities, of $9.2 million, and a $2.5 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 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 of discount 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, 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.

Current wording

For the nine months ended September 30, 2026, our investing activities provided $124.7 million of cash, which consisted of $193.8 million of proceeds from the maturities of marketable securities, partially offset by $69.1 million of purchases of marketable securities.

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, 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.

Current wording

For the nine months ended September 30, 2026, our financing activities provided $2.5 million of cash, which consisted of net proceeds from the issuance of common stock under our equity-based compensation plans.

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 our 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 our equity-based compensation plans.

Previous 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.

Current wording

As of September 30, 2026, we had total future minimum lease payments of $2.3 million, of which $1.0 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.