On February 27, 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 fourth quarter and full year ended December 31, 2024 (Press release, Cullinan Oncology, FEB 27, 2025, View Source [SID1234650700]).

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"Building on our execution throughout 2024, we are positioned to again deliver meaningful catalysts in 2025, starting with key updates for CLN-978 and zipalertinib," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "We have established an important competitive advantage in the immunology space as CLN-978 remains the first and only development-stage CD19 T cell engager with U.S. Food and Drug Administration (FDA) IND clearance in autoimmune diseases. We are further strengthening our leadership position by rapidly expanding our site footprint and preparing to deliver initial clinical data in SLE in the fourth quarter of 2025. For zipalertinib, we recently announced that the pivotal Phase 2b portion of the REZILIENT1 study met the primary endpoint of overall response rate. This milestone marks a significant achievement for Cullinan, our partner, Taiho, and most importantly, patients with EGFR exon20 insertion mutation NSCLC who have received prior therapy. Together with Taiho, we look forward to discussing next steps with the U.S. FDA and expect to submit an NDA in the second half of 2025. We look forward to continuing to progress these programs along with the rest of our pipeline."

Portfolio Highlights

Immunology

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CLN-978 (CD19xCD3 T cell engager): Systemic lupus erythematosus and rheumatoid arthritis
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The global Phase 1 study in moderate to severe SLE is ongoing with site expansion in the United States, Europe and Australia, and the Company plans to share initial clinical data in the fourth quarter of 2025.

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The Company remains on track to initiate a Phase 1 study in rheumatoid arthritis (RA) in the second quarter of 2025. The company-sponsored trial will be designed and executed in collaboration with FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Italy.
Oncology

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CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies
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The Company continues enrollment of disease-specific expansion cohorts of its Phase 1 study. Cullinan remains on track to report initial data for endometrial and cervical cancers in the second quarter of 2025.
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Enrollment continues in the ongoing Phase 1 study of CLN-619 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 full results will be submitted for presentation at an upcoming international medical conference and shared mid-year 2025. Pending discussions with the U.S. FDA, Taiho and Cullinan plan to submit for U.S. regulatory approval 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): AML and 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 residual disease (MRD) 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.
Fourth Quarter and Full Year 2024 Financial Results

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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $606.9 million as of December 31, 2024. 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 $40.5 million for the fourth quarter of 2024, compared to $34.8 million for the same period in 2023, and $142.9 million for the full year 2024, compared to $148.2 million for the full year 2023.
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G&A Expenses: General and administrative expenses were $14.6 million for the fourth quarter of 2024, compared to $10.6 million for the same period in 2023, and $54.0 million for the full year 2024, compared to $42.5 million for the full year 2023.
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Net Loss: Net loss attributable to Cullinan was $47.6 million for the fourth quarter of 2024, compared to $23.8 million for the same period in 2023, and $167.4 million for the full year 2024, compared to $153.2 million for the full year 2023.