Skye Bioscience Stock Price, News & Analysis
Company Description
Skye Bioscience, Inc. (Nasdaq: SKYE) is a clinical-stage biotechnology company based in San Diego, California. According to the company’s public statements, Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Its work is centered on obesity, overweight, and other metabolic health disorders, an area where the company highlights substantial human proof of mechanism for its chosen biologic targets.
Skye’s lead clinical asset is nimacimab, described as a potential first-in-class, peripherally restricted monoclonal antibody inhibitor of the cannabinoid receptor 1 (CB1). The company states that nimacimab functions as a negative allosteric modulating antibody that peripherally inhibits CB1, and that it is being developed as a non-incretin, non-peptide agent that acts independently of the GLP-1 pathway. Skye is conducting a Phase 2a clinical trial in obesity (ClinicalTrials.gov: NCT06577090) to evaluate nimacimab as a monotherapy and in combination with a GLP-1 receptor agonist (semaglutide, marketed as Wegovy).
The Phase 2a CBeyond™ proof-of-concept trial is a randomized, double-blind, placebo- and active-controlled study in adults with overweight or obesity. The company reports that the trial is designed to assess weight loss, safety, tolerability, pharmacokinetics, body composition, and other metabolic biomarkers. Patients are assigned to multiple arms, including nimacimab monotherapy, placebo, and combination arms pairing nimacimab or placebo with semaglutide. An extension phase is intended to provide up to 52 weeks of treatment followed by a post-treatment follow-up period to evaluate durability of weight loss and rebound weight gain.
In topline data from the 26-week treatment period of CBeyond, Skye reported that nimacimab 200 mg monotherapy did not meet its primary endpoint for weight loss versus placebo, and that preliminary pharmacokinetic analysis showed lower than expected drug exposure at this dose. The company states that this analysis supports evaluation of higher doses in subsequent studies. In the combination cohort, Skye reported that nimacimab 200 mg plus semaglutide produced additional weight loss compared to semaglutide alone, with no plateau observed at 26 weeks in the data presented. The company also highlights improvements in body composition measures, including lean mass to fat mass ratio and waist circumference, in the combination arm compared to control groups.
Across its clinical communications, Skye emphasizes the safety and tolerability profile of nimacimab. In the Phase 2a trial, the company reports that nimacimab at 200 mg demonstrated placebo-like tolerability as a monotherapy and, when combined with semaglutide, did not increase gastrointestinal adverse events compared with semaglutide alone. Skye further notes that no nimacimab-associated neuropsychiatric adverse events were observed in the Phase 2a study. Earlier Phase 1b data in subjects with metabolic-associated steatotic liver disease (MASLD) are described as showing that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity, with no serious adverse events, no discontinuations due to adverse events, and no neuropsychiatric safety signals.
Skye also reports preclinical findings from diet-induced obesity (DIO) mouse models. In these studies, nimacimab is described as a peripherally acting CB1-inhibiting monoclonal antibody that, in preclinical settings, demonstrated significant weight loss as a monotherapy and in combination with incretin-based therapies such as tirzepatide. The company states that nimacimab showed durable post-treatment weight maintenance compared to tirzepatide alone and reduced rebound weight gain after treatment with tirzepatide or nimacimab plus tirzepatide. Skye has also reported preclinical data suggesting modulation of gut and adipose hormones that are integral to metabolic and anti-inflammatory processes.
According to Skye, these clinical and preclinical results support its view that peripheral CB1 inhibition via an antibody such as nimacimab may complement GLP-1 and other incretin-based therapies. The company’s communications describe potential roles for nimacimab in combination regimens and in maintenance settings, particularly in the context of weight regain after discontinuation of GLP-1 therapy. Skye also notes that gastrointestinal side effects are a frequent cause of discontinuation for existing obesity therapies and highlights the tolerability profile it has observed for nimacimab to date.
Operationally, Skye reports that it has advanced chemistry, manufacturing, and controls (CMC) and clinical supply activities to support planned follow-on studies of nimacimab. The company has described manufacturing scale-up and production of nimacimab drug supply intended to support higher-dose evaluation and future clinical trials. To enable higher-dose subcutaneous administration, Skye has entered into a non-exclusive global collaboration and license agreement with Halozyme Therapeutics, Inc. to use Halozyme’s ENHANZE drug delivery technology. Under this collaboration, Skye is developing a subcutaneous formulation of nimacimab with ENHANZE to facilitate delivery of larger injection volumes and to support evaluation of higher nimacimab doses in obesity, including in combination with GLP-1 receptor agonists.
Skye’s public disclosures also reference earlier development history for nimacimab. The company notes that a Phase 1b study in MASLD was originally conducted by Bird Rock Bio, Inc., which Skye acquired in 2023, and that these data contribute to its understanding of nimacimab’s safety, pharmacokinetics, and potential role in metabolic diseases. Skye positions its broader strategy as leveraging biologic targets with substantial human proof of mechanism to develop potential first-in-class therapeutics with clinical and commercial differentiation in metabolic health.
Business focus and therapeutic area
Based on its own descriptions, Skye Bioscience is focused on metabolic health disorders, with a primary emphasis on obesity and overweight. The company characterizes obesity as a multifactorial disease involving multiple organs, including liver, adipose tissue, and muscle, and positions peripheral CB1 inhibition as a mechanism that may address aspects of metabolic homeostasis. Skye’s ongoing clinical and preclinical programs are intended to explore nimacimab’s role across monotherapy, combination, and maintenance settings in the obesity treatment landscape.
Clinical development programs
- CBeyond™ Phase 2a obesity trial: A randomized, double-blind, placebo- and active-controlled study in adults with overweight or obesity, evaluating nimacimab 200 mg as monotherapy versus placebo and in combination with semaglutide versus semaglutide plus placebo over a 26-week treatment period, with an extension phase to 52 weeks and follow-up to assess weight regain.
- Phase 2a extension study: A 26-week extension designed to provide a total of 52 weeks of treatment and a follow-up period. In the extension, patients in the monotherapy arm receive a higher dose of nimacimab (300 mg), while combination-arm patients continue blinded treatment with nimacimab or placebo along with semaglutide.
- Phase 1b MASLD study: A multiple-dose study in subjects with metabolic-associated steatotic liver disease, evaluating safety, tolerability, pharmacokinetics, and immunogenicity of nimacimab across multiple ascending dose cohorts.
Regulatory and corporate information
Skye Bioscience, Inc. is incorporated in Nevada and files reports with the U.S. Securities and Exchange Commission (SEC) under Commission File Number 000-55136. The company’s SEC filings, including Form 8-K reports, reflect its status as a clinical-stage biotechnology issuer and provide periodic updates on financial results and material corporate events. Recent Form 8-K filings have been used to furnish press releases on clinical data, financial results, and corporate updates.