On November 6, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company accelerating potential high-impact therapies in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the third quarter ended September 30, 2025.
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"Cullinan is strategically focusing resources and development efforts on select, high-conviction clinical stage programs. We are well-positioned to further concentrate resources on CLN-978, a CD19xCD3 bispecific T cell engager, and we plan to share initial clinical data in autoimmune diseases in the first half of 2026. We are also particularly encouraged by the emerging efficacy profile of CLN-049, our FLT3xCD3 bispecific T cell engager, and we look forward to unveiling important clinical data in an oral presentation at the upcoming 2025 ASH (Free ASH Whitepaper) Annual Meeting in December. We believe the differentiated mechanism of CLN-049 supports its potential to address a broad population of AML patients regardless of mutational status, including those with poor prognostic features," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.
"Additionally, following a positive pre-NDA meeting with the FDA in October, our partner Taiho plans to initiate a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins NSCLC by year-end and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. Finally, after reviewing emerging clinical data, we have decided not to pursue further development of CLN-619 and CLN-617. Notably, our core pipeline is now focused on T cell engagers applied to well-validated targets with transformative potential in immunology and oncology. This focused pipeline extends our cash runway into 2029 and provides us ample financial resources to deliver meaningful value-driving catalysts across our programs in 2026 and beyond."
Portfolio Highlights
Immunology
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CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren’s disease (SjD).
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The Phase 1 OUTRACE Program is enrolling and treating patients across the OUTRACE SLE, OUTRACE RA and OUTRACE SjD Studies. The Company plans to share initial safety and B cell depletion data in SLE and RA in the first half of 2026.
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The Company was issued a key composition of matter patent by the United States Patent and Trademark Office, which is expected to extend patent protection until at least 2042, excluding possible patent term extension.
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Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
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Genrix Bio, from whom Cullinan licensed velinotamig in June 2025, plans to initiate a Phase 1 study in China in patients with autoimmune diseases by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology
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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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Following a positive Type B pre-NDA meeting with the U.S. Food and Drug Administration in October, Taiho plans to initiate a rolling submission of an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.
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The Company shared updated efficacy and safety data demonstrating responses in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.
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Taiho shared initial data from the REZILIENT2 cohort demonstrating the clinical activity of zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC.
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Taiho also shared initial data from the REZILIENT2 cohort demonstrating intracranial responses with zipalertinib in patients with active brain metastases at the ESMO (Free ESMO Whitepaper) Congress 2025.
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CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS. The Company recently shared clinical data in a published ASH (Free ASH Whitepaper) abstract and updated results will be shared in an oral presentation at the 2025 ASH (Free ASH Whitepaper) Annual Meeting on December 8, 2025. CLN-049 demonstrated promising anti-leukemic activity, including a ~30% CRc rate at clinically active target doses, in a heavily pretreated population of patients, regardless of FLT3 mutational status.
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Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.
Third Quarter 2025 Financial Results
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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $475.5 million as of September 30, 2025. Cullinan expects its cash resources to provide runway into 2029 under its new operating plan.
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R&D Expenses: Research and development expenses were $42.0 million for the third quarter of 2025, compared to $35.5 million for the same period in 2024.
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G&A Expenses: General and administrative expenses were $13.6 million for the third quarter of 2025, compared to $13.3 million for the same period in 2024.
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Net Loss: Net loss attributable to Cullinan was $50.6 million for the third quarter of 2025, compared to $40.6 million for the same period in 2024.
(Press release, Cullinan Oncology, NOV 6, 2025, View Source [SID1234659564])