On May 7, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the first quarter ended March 31, 2026.
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"T cell engagers have the potential to transform outcomes for people living with autoimmune diseases and cancer, and emerging clinical data underscore their promise as a compelling therapeutic modality. We look forward to sharing initial clinical data for CLN-978 and velinotamig throughout 2026. CD19 and BCMA are now well-validated autoimmune targets, and by addressing both, we aim to comprehensively treat more diseases and redefine standards of care for more patients with these two clinical-stage programs. Similarly, the early success of CLN-049 in AML further reinforces the remarkable promise of T cell engagers in many high unmet need disease settings across immunology and oncology" said Nadim Ahmed, President and CEO of Cullinan Therapeutics.
"Further, with our partner Taiho, we announced FDA acceptance of our first NDA submission, representing a significant milestone for Cullinan Therapeutics and bringing zipalertinib meaningfully closer to being available for patients, with a PDUFA date of February 27, 2027. With multiple upcoming catalysts and milestones across the pipeline through 2026 and beyond, the company is well-positioned for continued momentum and 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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In June, the Company will share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, as well as other biomarker data and preliminary clinical activity data. The initial data will be presented in a poster session at the EULAR 2026 Congress on June 6, 2026.
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OUTRACE RA
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In June, the Company will share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data. The initial data will be presented in a poster session at the EULAR 2026 Congress on June 6, 2026.
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In Q3 2026, the Company plans to share initial multi-dose regimen data, including B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
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OUTRACE SjD
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In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
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Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases
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Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, starting with moderate to severe SLE and to be followed by planned expansion into other indications. Initial multi-dose regimen data from the dose escalation phase in patients with SLE are expected to be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development.
Oncology
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CLN-049 (FLT3xCD3 T cell engager): acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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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 H2 2026. Dose level expansion continues in order to determine the recommended Phase 2 dose (RP2D) by Q4 2026 for a potential single-arm pivotal registrational trial.
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In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in patients with previously untreated AML.
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Enrollment continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.
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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.
First Quarter 2026 Financial Results
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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $393.3 million as of March 31, 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 $42.1 million for the first quarter of 2026, compared to $41.5 million for the same period in 2025.
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G&A Expenses: General and administrative expenses were $11.6 million for the first quarter of 2026, compared to $13.5 million for the same period in 2025.
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Net Loss: Net loss was $49.7 million for the first quarter of 2026, compared to $48.5 million for the same period in 2025.
(Press release, Cullinan Oncology, MAY 7, 2026, View Source [SID1234665318])