On May 8, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and anticipated business highlights and announced its financial results for the first quarter ended March 31, 2025 (Press release, Cullinan Oncology, MAY 8, 2025, View Source [SID1234652741]).

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"As a leader in T cell engager development for autoimmune diseases, we continue to rapidly advance our global clinical development of CLN-978 in several autoimmune diseases and across multiple geographies. With an extensive global network of clinical investigators, CLN-978 is now in active clinical development in systemic lupus erythematosus (SLE), rheumatoid arthritis and Sjögren’s disease and we expect to deliver initial clinical data in SLE by the end of the year," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.

"In parallel, we continue to advance and refine our oncology programs. We recently announced that the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib met the primary endpoint of overall response rate. Together with our partner Taiho, we will share the results in an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. For CLN-619, our MICA/B antibody, we are narrowing the scope of the program, which will allow for reallocation of resources. With $567.4 million in cash and investments and runway into 2028, we have the resources required to maintain our leadership position in autoimmune diseases and deliver meaningful value-driving catalysts across both our immunology and oncology programs."

Portfolio Highlights

Immunology

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CLN-978 (CD19xCD3 T cell engager): Systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease
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The global Phase 1 study in patients with moderate to severe SLE is ongoing in the United States, Europe, and Australia, and the Company plans to share initial clinical data in Q4 2025.
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In April 2025, the Company received approval from EMA to initiate a Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis. The Company expects to initiate the study at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy in Q2 2025.
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In April 2025, the Company announced plans to initiate a Phase 1 study in patients with active, moderate to severe Sjögren’s disease in the U.S. in Q2 2025.
Oncology

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CLN-619 (Anti-MICA/MICB monoclonal antibody): NSCLC and multiple myeloma
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Following a review of the data from the disease-specific expansion cohorts for endometrial and cervical cancers, the Company has discontinued further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet the internal threshold for advancement.
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Cullinan will continue enrolling to go/no-go decisions the ongoing expansion cohorts in patients with NSCLC and the ongoing Phase 1 study in patients with relapsed/refractory multiple myeloma.
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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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In January 2025, Cullinan announced that the pivotal Phase 2b portion of REZILIENT1 met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The results will be presented during an oral abstract session at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on June 1, 2025.
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Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed/refractory EGFR ex20ins NSCLC in the second half of 2025. Taiho continues enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC.

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CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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Enrollment continues in the ongoing Phase 1 study in patients with relapsed/refractory AML or MDS, and in the ongoing Phase 1 study in patients with measurable minimal residual disease in AML.
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CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
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Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.
First Quarter 2025 Financial Results

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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $567.4 million as of March 31, 2025. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.
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R&D Expenses: Research and development expenses were $41.5 million for the first quarter of 2025, compared to $30.6 million for the same period in 2024.
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G&A Expenses: General and administrative expenses were $13.5 million for the first quarter of 2025, compared to $12.3 million for the same period in 2024.
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Net Loss: Net loss attributable to Cullinan was $48.5 million for the first quarter of 2025, compared to $37.1 million for the same period in 2024.