Cullinan Oncology Inc Stock Price, News & Analysis

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 secured exclusive global rights (excluding Greater China) to velinotamig, a BCMAxCD3 bispecific T cell engager, from Genrix Bio. The deal includes a $20 million upfront payment, potential milestone payments up to $692 million, and tiered royalties ranging from mid-single digits to mid-teens. Velinotamig has shown promising Phase 2 results in multiple myeloma patients and will be developed for autoimmune diseases. Genrix Bio will initiate a Phase 1 study in China for autoimmune diseases by year-end, with data to be used by Cullinan for global development. The acquisition complements Cullinan's existing CLN-978 program and maintains their cash runway into 2028.

Taiho Oncology and Cullinan Therapeutics (CGEM) announced positive Phase 1/2 REZILIENT1 trial results for zipalertinib in treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The study demonstrated significant efficacy with a 35.2% confirmed objective response rate across 176 patients, including those previously treated with amivantamab. The median duration of response was 8.8 months, with progression-free survival of 9.4 months. Notably, patients treated after platinum-based chemotherapy showed a 40% response rate. The drug showed promising results in patients with brain metastases (30.9% ORR) and maintained a manageable safety profile. The company is currently recruiting for the Phase 3 REZILIENT3 trial.

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, Taiho Pharmaceutical, and Taiho Oncology revealed positive results from their Phase 2b REZILIENT1 trial of zipalertinib for treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The trial enrolled 244 patients, with key findings showing: - 35% confirmed overall objective response rate (ORR) in the efficacy population (n=176) - 40% ORR in patients with prior platinum-based chemotherapy - 30% ORR in patients with prior chemo and amivantamab - Median duration of response of 8.8 months The drug demonstrated a manageable safety profile, with most treatment-related adverse events being grade 1 or 2. Common side effects included paronychia (38.5%), rash (30.3%), and dermatitis acneiform (24.6%). The findings will be presented at the 2025 ASCO Annual Meeting.

Cullinan Therapeutics (NASDAQ: CGEM) reported Q1 2025 financial results and provided key updates on its pipeline. The company received EMA approval for CLN-978 and plans to initiate Phase 1 studies in rheumatoid arthritis and Sjögren's disease in Q2 2025. Their pivotal drug zipalertinib met its primary endpoint in the REZILIENT1 study for NSCLC treatment, with results to be presented at ASCO 2025. The company narrowed focus for CLN-619, discontinuing development for gynecological cancers while continuing NSCLC and multiple myeloma trials. Financially, Cullinan reported $567.4 million in cash with runway into 2028, though net losses increased to $48.5 million in Q1 2025 from $37.1 million in Q1 2024. R&D expenses rose to $41.5 million from $30.6 million year-over-year.

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.