On August 6, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2026.

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"At our recent Immunology Day event, we shared compelling initial clinical data for CLN-978 and velinotamig, two T cell engagers with potential to achieve immune reset and transform outcomes for people living with autoimmune diseases. We look forward to sharing additional clinical data throughout the remainder of 2026 as we rapidly advance these programs towards Phase 2 studies," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"Additionally, following a positive End-of-Phase 1 meeting with the FDA in July, we will begin a potentially registrational Phase 2 study in patients with relapsed or refractory AML this quarter. CLN-049 represents a promising novel immunotherapeutic approach for a broad population of AML patients who currently have limited treatment options and poor prognosis. With our leadership position in the T cell engager space, we are quickly advancing a differentiated pipeline across immunology and oncology to late-stage development. Together with multiple upcoming catalysts, the company is very well-positioned for significant value creation."

Portfolio Highlights and 2026 Milestones

Immunology

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CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe systemic lupus erythematosus (SLE), difficult-to-treat rheumatoid arthritis (RA), and treatment-refractory moderate to severe Sjögren’s disease (SjD)
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OUTRACE SLE
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At the EULAR 2026 Congress in June, the Company presented promising initial single target dose data, which demonstrated the potential for immune reset in a refractory and heterogeneous SLE population. CLN-978 also improved lab markers of disease activity and demonstrated deep, dose-dependent B cell depletion in peripheral blood as well as dose-dependent recovery with a favorable safety profile.
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In Q4 2026, the Company plans to share initial multi-dose regimen data. The Company also plans to begin Phase 2 expansion in early 2027 in patients with SLE and in patients with lupus nephritis.
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OUTRACE RA
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At the EULAR 2026 Congress and the Company’s Immunology Day event in June, the Company presented promising initial single target dose and multi-dose regimen data, which demonstrated the potential for immune reset in a heavily pretreated RA population with high baseline disease activity. CLN-978 improved disease activity in most patients, including two DAS28-ESR remissions in poly-refractory patients. CLN-978 also reduced autoantibody levels while preserving vaccine titers, and demonstrated deep, dose-dependent B cell depletion in peripheral blood and tissues with a favorable safety profile.
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In Q3 2026, the Company plans to share additional multi-dose regimen data. The Company also plans to begin Phase 2 expansion in early 2027.
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OUTRACE SjD
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In Q4 2026, the Company plans to share initial data from the single target dose escalation portion of the study.
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Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells

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At the Company’s Immunology Day event in June, encouraging early clinical observations from the Genrix Bio Phase 1/2 study in China were shared. Two patients with SLE and nephritis treated with multi-dose velinotamig achieved complete renal response, and a favorable safety profile was observed. Additional multi-dose regimen data from the study are expected to be shared in Q4 2026.
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Cullinan plans to initiate a global Phase 1/2 basket study in early 2027 in patients with autoimmune cytopenias, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA).
Oncology

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CLN-049 (FLT3xCD3 T cell engager): acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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Following a positive End-of-Phase 1 meeting with the U.S. FDA in July, the Company will initiate a potentially registrational Phase 2 study in patients with relapsed/refractory AML in Q3 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 (RP2D).
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The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in Q4 2026.
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In Q4 2026, the Company will initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML.
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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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In April, the U.S. FDA accepted an NDA for zipalertinib for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.
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In February, Taiho completed enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC. Taiho expects to obtain top-line results by the end of 2026.
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Cullinan is eligible to receive $30 million and up to $100 million upon 2L and 1L U.S. regulatory approvals, respectively, and a 50/50 profit share in the U.S.
Second Quarter 2026 Financial Results

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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $356.0 million as of June 30, 2026. Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

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R&D Expenses: Research and development expenses were $44.4 million for the second quarter of 2026, compared to $61.0 million for the same period in 2025.
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G&A Expenses: General and administrative expenses were $12.8 million for the second quarter of 2026, compared to $14.8 million for the same period in 2025.
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Net Loss: Net loss was $53.7 million for the second quarter of 2026, compared to $70.1 million for the same period in 2025.

(Press release, Cullinan Oncology, AUG 6, 2026, View Source [SID1234669791])