Cullinan Oncology Inc Stock Price, News & Analysis

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.

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.

Cullinan Therapeutics (NASDAQ: CGEM) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical pipeline. The company's lead candidate CLN-978, the first CD19 T cell engager in autoimmune disease trials in the U.S., expects initial clinical data for Systemic Lupus Erythematosus in Q4 2025. Zipalertinib's pivotal Phase 2b study met its primary endpoint, with NDA submission planned for H2 2025.

Financial highlights include cash position of $606.9 million providing runway into 2028. Q4 2024 showed R&D expenses of $40.5 million and G&A expenses of $14.6 million. The company reported a net loss of $47.6 million for Q4 2024 and $167.4 million for the full year.

Cullinan Therapeutics (Nasdaq: CGEM) has announced its participation in two major upcoming investor conferences in March 2025. The company's leadership team, including Chief Executive Officer Nadim Ahmed and Chief Medical Officer Jeffrey Jones, will engage in fireside chats at both events.

The first appearance will be at the TD Cowen 45th Annual Health Care Conference in Boston on March 4, 2025, at 11:10 a.m. ET. The second presentation is scheduled for the Leerink Partners Global Healthcare Conference in Miami Beach on March 11, 2025, at 11:20 a.m. ET.

Investors and interested parties can access webcasts of both fireside chats through the Events and Presentations section of Cullinan's investor relations website.