Skye Bioscience reports positive Phase 1b results for liver disease drug

SAN DIEGO - Skye Bioscience, Inc. (NASDAQ:SKYE) announced Friday that its CB1-inhibiting antibody nimacimab demonstrated a favorable safety and tolerability profile in a Phase 1b study of patients with metabolic-associated steatotic liver disease (MASLD). The announcement comes as the company’s stock has shown remarkable momentum, with InvestingPro data showing a 26.9% return over the past year and trading near $57, up significantly from its 52-week low of $36.15.

The results, presented at the European Association for the Study of Diabetes Annual Meeting, showed that nimacimab was safe and well-tolerated across multiple ascending dose cohorts, with predictable pharmacokinetics and low immunogenicity.

No serious adverse events or discontinuations due to adverse events were reported in the study. Notably, researchers observed no neuropsychiatric safety signals, while gastrointestinal side effects were described as infrequent and mild.

"These Phase 1b results provide an early glimpse of the benchmark safety and tolerability profile that we believe sets nimacimab apart within the broader anti-obesity medicine landscape," said Puneet Arora, Chief Medical Officer of Skye Bioscience, in the press release.

The clinical-stage biotechnology company is currently conducting a Phase 2a trial evaluating nimacimab in obesity, including its combination with a GLP-1 receptor agonist. The company indicated that the favorable findings in this obese, diabetic MASLD population support nimacimab’s potential role in treating metabolic diseases. According to InvestingPro analysis, Skye maintains strong financial health with cash reserves exceeding debt levels and liquid assets covering short-term obligations, though it remains unprofitable over the last twelve months.Want deeper insights? InvestingPro subscribers have access to 8 additional key ProTips and comprehensive financial analysis for SKYE.

The Phase 1b study was originally conducted by Bird Rock Bio, Inc., which Skye acquired in 2023.

Skye Bioscience focuses on developing next-generation molecules that modulate G-protein coupled receptors for metabolic health disorders, according to the company statement. The company has achieved an "GREAT" overall financial health score of 3.65 on InvestingPro’s proprietary rating system.

In other recent news, Skye Bioscience reported its Q2 2025 earnings, revealing a net loss of $17.6 million. This loss was primarily attributed to a significant increase in research and development expenses as the company invested in its obesity treatment pipeline. Additionally, Skye Bioscience announced promising preclinical results for its experimental obesity treatment, nimacimab. The treatment, when combined with tirzepatide, demonstrated over 40% weight loss in diet-induced obese mice and showed reduced rebound weight gain compared to tirzepatide alone. In anticipation of the upcoming Phase 2a CBeyond clinical trial results, JMP Securities has reiterated its Market Outperform rating on Skye Bioscience, setting a price target of $15.00. Skye Bioscience is also organizing a virtual expert panel to discuss these results and the potential role of peripheral CB1 inhibition in obesity treatment. These developments highlight the company’s ongoing efforts in advancing its obesity treatment research.

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