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CAMBRIDGE, Mass. - Cullinan Therapeutics, Inc. (NASDAQ: CGEM), a clinical-stage biotech company with a market capitalization of $454 million, announced today the initiation of a clinical study for its drug candidate CLN-978, targeting patients with Sjögren’s disease (SjD) in the United States. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, though its stock has declined over 71% in the past year. This study follows the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) Application clearance for CLN-978, which is also under investigation for systemic lupus erythematosus (SLE) and rheumatoid arthritis.
The trial will involve patients with active, moderate to severe Sjögren’s disease who meet specific medical criteria, including the presence of certain antibodies. Similar to the SLE study, the trial will use a dose escalation scheme to assess the safety, tolerability, and pharmacological properties of CLN-978, as well as its impact on disease activity.
Dr. Jeffrey Jones, Chief Medical Officer at Cullinan Therapeutics, expressed optimism about the expansion of the clinical development program to include Sjögren’s disease. He highlighted the novel approach of the bispecific T cell engager CLN-978, which targets CD19 and aims to deplete B cells with a convenient subcutaneous administration.
The need for innovative treatments is underscored by the lack of approved therapies that comprehensively address Sjögren’s disease, a chronic autoimmune condition affecting an estimated four million Americans. Symptoms include dryness, fatigue, pain, and potential organ involvement, often leading to a reduced quality of life. While the company’s current ratio of 13.5 indicates strong short-term financial stability, InvestingPro analysis shows the company is not yet profitable, with analysts expecting continued losses this year.
The investigational drug is part of a broader international research effort, with studies already underway for SLE in the U.S., Australia, and Europe, and for rheumatoid arthritis across multiple European sites. The Sjögren’s disease study is set to open at multiple U.S. locations and globally within this quarter.
CLN-978 is designed as a highly potent CD19xCD3 bispecific T cell engager, engineered to target B cells with high affinity, potentially offering a new treatment option for patients with various autoimmune diseases.
This announcement is based on a press release statement from Cullinan Therapeutics. The company’s forward-looking statements are subject to risks and uncertainties that could affect the actual results of the clinical trials and the future commercial potential of CLN-978. With analysts setting price targets between $27 and $36, InvestingPro subscribers can access additional insights, including 8 more exclusive ProTips and detailed financial metrics to better evaluate the company’s potential. The next earnings announcement is expected on May 20, 2025.
In other recent news, Cullinan Therapeutics received approval from the European Medicines Agency to proceed with a Phase 1 clinical trial for its drug candidate CLN-978, aimed at treating difficult-to-treat rheumatoid arthritis. This trial is scheduled to begin in the second quarter of 2025 and will assess the drug’s safety and efficacy at research institutions in Germany and Italy. CLN-978 is also being investigated for systemic lupus erythematosus in various regions, including the U.S., Europe, and Australia. In another development, H.C. Wainwright raised its price target for Cullinan Oncology to $33, maintaining a Buy rating. This adjustment follows the successful completion of the Phase 2b REZILIENT1 trial, which met its primary endpoint for the treatment of non-small cell lung cancer with the drug zipalertinib. The trial’s results showed a positive overall response rate, and the safety profile was consistent with previous data. Cullinan Oncology is planning discussions with the FDA for regulatory approval in the U.S., aiming for submission in the latter half of 2025. Additionally, Cullinan is conducting further studies, REZILIENT3 and REZILIENT2, for first-line treatment and parallel cohort studies, respectively, which are currently enrolling patients.
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