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SAN DIEGO - Skye Bioscience, Inc. (NASDAQ:SKYE), whose stock has shown a notable 25% gain over the past year according to InvestingPro data, announced Thursday that its experimental obesity treatment nimacimab demonstrated over 40% weight loss in preclinical studies when combined with tirzepatide in diet-induced obese mice.
The clinical-stage biotechnology company, which maintains a strong financial position with cash reserves exceeding debt levels, reported results from two new preclinical studies evaluating nimacimab, a peripherally-acting CB1-inhibiting monoclonal antibody. The studies showed nimacimab reduced rebound weight gain following treatment discontinuation compared to tirzepatide alone.
In head-to-head testing against monlunabant, another CB1 inhibitor, nimacimab demonstrated similar or better weight loss while showing superior post-treatment maintenance of weight loss.
The company highlighted three key findings: nimacimab showed differentiation from monlunabant with potentially better safety and tolerability; enhanced weight loss when combined with tirzepatide; and reduced weight regain by over 50% when tirzepatide treatment ended.
"Nimacimab can potentially both amplify and sustain weight loss, amplify in combination with GLP-1 therapy, and potentially sustain by limiting rebound when treatment is ended," said Punit Dhillon, Chief Executive Officer of Skye, according to the press release.
The company is currently conducting a Phase 2a clinical trial of nimacimab in obesity, including assessment of its combination with a GLP-1R agonist. Top-line data from this study is expected in late third quarter or early fourth quarter of 2025.
These findings were presented during a virtual key opinion leader event where academic and clinical experts discussed how combining and sequencing peripherally-acting CB1 antagonism with GLP-1s could potentially improve weight loss outcomes.
The preclinical results suggest nimacimab could potentially serve as a standalone treatment, combination therapy, or maintenance therapy in obesity management, according to the company’s statement.
In other recent news, Skye Bioscience reported its Q2 2025 earnings, revealing a significant rise in research and development expenses. The company experienced a net loss of $17.6 million, attributed to strategic investments in its obesity treatment pipeline. These developments have raised concerns among investors regarding the company’s long-term profitability. Additionally, Skye Bioscience is set to host a virtual expert panel discussing the upcoming results from its Phase 2a CBeyond trial. This trial focuses on nimacimab, a peripheral CB1 antibody aimed at treating obesity. The event will feature specialists who will discuss the potential role of peripheral CB1 inhibition as a therapeutic pathway for weight loss. These recent developments indicate Skye Bioscience’s continued focus on advancing its obesity treatment research.
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