Cullinan Therapeutics, Inc. develops clinical-stage therapies for autoimmune diseases and cancer, with a pipeline centered on T cell engagers and targeted oncology programs. Recurring news includes updates on CLN-978, a CD19xCD3 T cell engager for autoimmune diseases; velinotamig, a BCMAxCD3 program; CLN-049, a FLT3xCD3 bispecific T cell engager for relapsed or refractory AML and MDS; and zipalertinib for EGFR exon 20 insertion-mutated non-small cell lung cancer.
Company announcements commonly cover clinical data presentations, regulatory submissions and FDA communications, portfolio prioritization, collaborations involving zipalertinib, quarterly financial results, cash runway commentary and healthcare investor conference participation.
Cullinan Therapeutics (NASDAQ:CGEM) provided a comprehensive Q2 2025 corporate update, highlighting significant progress across its immunology and oncology portfolios. The company reported $510.9 million in cash and investments, providing runway into 2028. Key developments include active enrollment in Phase 1 studies for CLN-978 across multiple autoimmune conditions, the in-licensing of velinotamig from Genrix Bio for $20 million upfront, and advancement of zipalertinib's pivotal trials.
Financial results show R&D expenses of $61.0 million (up from $36.3M in Q2 2024) and a net loss of $70.1 million (increased from $42.0M). The company strengthened its board with the appointments of Drs. Mittie Doyle and Andrew Allen, while announcing upcoming data presentations across multiple programs at major medical conferences.
Cullinan Therapeutics (NASDAQ:CGEM) and Taiho Oncology announced the acceptance of two abstracts for presentation at the IASLC 2025 World Conference on Lung Cancer in Barcelona, featuring new data for zipalertinib in non-small cell lung cancer (NSCLC).
The presentations will include updated efficacy data from the Phase 2b REZILIENT1 trial studying zipalertinib in patients with EGFR exon 20 insertion mutations who previously received amivantamab treatment. Additionally, preliminary findings from the Phase 2 REZILIENT2 trial will be presented, focusing on patients with uncommon non-ex20ins EGFR mutations.
Both abstracts will be presented on September 9, 2025, during the mini oral session "Common and Uncommon EGFR Mutations, New Treatments in the Horizon." Full abstract details will be available on August 13, 2025.
Cullinan Therapeutics (NASDAQ: CGEM) has announced two upcoming investor events in June 2025. The company will host an analyst and investor event on June 1, 2025, at 6:30 p.m. CT during the 2025 ASCO Annual Meeting in Chicago, following the presentation of pivotal Phase 2b REZILIENT1 trial results for zipalertinib in EGFR exon20 insertion NSCLC patients. Additionally, Cullinan will participate in the Jefferies 2025 Global Healthcare Conference in New York from June 3-5, featuring a panel discussion on cell therapy and a company presentation by CEO Nadim Ahmed and CMO Jeffrey Jones. Both events will be webcast on the company's investor relations website.
Cullinan Therapeutics is expanding its clinical development program for CLN-978, a novel bispecific CD19 T cell engager, to include Sjögren's disease patients in the United States. This marks CLN-978 as the first CD19 T cell engager to receive FDA IND clearance for autoimmune diseases.
The study will focus on patients with active, moderate to severe Sjögren's disease who meet specific clinical criteria. The trial's primary goal is to assess safety and tolerability, with secondary objectives including pharmacokinetics and disease activity effects.
CLN-978 is already being studied for systemic lupus erythematosus in the U.S., Australia, and Europe, and for rheumatoid arthritis at European sites. The treatment offers a differentiated approach through deep B cell depletion and convenient subcutaneous administration. With approximately 4 million Americans affected by Sjögren's disease and no currently approved comprehensive treatments, this development addresses a significant unmet medical need.
Cullinan Therapeutics (NASDAQ: CGEM) announced that results from their REZILIENT1 study of zipalertinib in non-small cell lung cancer (NSCLC) patients will be presented at the 2025 ASCO Annual Meeting. The Phase 2b trial, which met its primary endpoint of overall response rate, evaluated zipalertinib monotherapy in patients with advanced or metastatic EGFR exon 20 insertion mutations who progressed after prior platinum-based chemotherapy.
The study demonstrated clinically meaningful efficacy and a manageable safety profile in patients previously treated with platinum-based chemotherapy, including those treated with amivantamab. Dr. Helena A. Yu from Memorial Sloan Kettering Cancer Center will present the findings on June 1, 2025. The company will also host an investor event featuring Dr. Danny Nguyen from City of Hope National Medical Center to discuss the data.
Cullinan Therapeutics (Nasdaq: CGEM) has received European Medicines Agency (EMA) approval for a Phase 1 clinical trial of CLN-978, a bispecific CD19 T cell engager, in rheumatoid arthritis patients. The trial will commence in Q2 2025 at research institutions in Germany and Rome.
The open-label study will evaluate CLN-978's safety, pharmacokinetics, pharmacodynamics, and effects on disease activity in patients with active, difficult-to-treat rheumatoid arthritis. The drug is administered subcutaneously and is currently being studied for systemic lupus erythematosus across the U.S., Europe, and Australia.
CLN-978 is notable as the only CD19-targeting T cell engager with a global regulatory development plan including FDA-cleared IND. The therapy aims to provide off-the-shelf access and convenient subcutaneous dosing for autoimmune disease patients.