Business Description

. Overview Skye Bioscience, Inc. is a clinical-stage biotechnology company pioneering next-generation molecules that modulate G-protein-coupled receptors ("GPCRs") to treat obesity, overweight, and metabolic disorders. Our lead candidate, nimacimab, is a peripherally restricted negative allosteric modulating antibody targeting cannabinoid receptor 1 ("CB1")—a key GPCR involved in metabolic regulation. Except where the context indicates otherwise, references to "we," "us," "our," "Skye" or the" Company" refer to the company and its subsidiaries. Strategy We believe there is a growing demand for therapies that offer improved safety, efficacy, tolerability, quality of life and long-term health outcomes while addressing the limitations of currently approved treatments. Our objective is to drive innovation in the treatment landscape for obesity, overweight and metabolic disorders by developing potential first-in-class therapies that meet significant unmet medical needs globally. 4 Table of Contents Key elements of our strategy include: • Advancing nimacimab through clinical development for the treatment of patients with obesity and overweight as a combination therapy and evaluating its potential as a standalone or second-line therapy. • Expanding the clinical utility of nimacimab by exploring additional metabolic indications where inflammation and fibrosis c ontribute to disease progression, utilizing translational models to identify new therapeutic applications . • Evaluating combination approaches by assessing nimacimab in combination with incretin-based therapies to enhance efficacy and patient outcomes in obesity and metabolic health management. • Pursuing value add strategic partnerships and business development opportunities, including collaborations, licensing agreements, and other transactions to accelerate the clinical and commercial development of nimacimab. • Developing next generation GPCR-targeting molecules designed to address metabolic disorders. • Expanding our pipeline through in-licensing or acquisitions of complementary metabolic health technologies and product candidates that target GPCRs and align with our strategic vision. Our Product Candidate Nimacimab We completed the acquisition of Bird Rock Bio, Inc. (“Bird Rock”), a privately held, clinical-stage biotechnology company, in August 2023. Through this transaction, we acquired nimacimab, a humanized IgG4 negative allosteric modulating ("NAM") antibody that specifically binds to the CB1 receptor with no cross-reactivity to certain other GPCRs, including cannabinoid receptor 2 ("CB2") . Unmet Need and Market Opportunity Obesity is a complex, heterogeneous, chronic, and progressive disease, which substantially affects health, quality of life and mortality. "Obesity" and "severe obesity" are defined by a body mass index ("BMI") of greater than 30 and 40 kg/m2, respectively, with abnormal or excessive fat accumulation. "Overweight" is defined by a BMI of greater than 25 kg/m2. Obesity and overweight states are characterized by a chronic energy surplus in which the body’s energy intake exceeds its energy expenditure and are often associated with excess and chronic inflammation of adipose and other tissues. Other stressors and environmental factors contribute to this chronic imbalance. Today, obesity is the fifth-leading risk factor cited by the World Health Organization ("WHO") for contributing as a primary cause of death globally. Based on estimates by the WHO, globally, obesity affected more than 890 million adults as of 2022, and we believe it has continued to increase in prevalence worldwide since the WHO declared a global obesity epidemic in 1997. In addition, the WHO estimates that 2.5 billion adults were overweight as of 2022. Current estimates by the World Obesity Atlas suggest that 54% of the global population will be overweight or obese by 2035, compared to 46% in 2025. In addition, it is estimated that 39% of, or 770 million, children between the ages of five and nineteen years of age will be overweight or obese by 2035 compared to 28% of, or 550 million, such children in 2025. Based on several analyst estimates, we believe this deeply rooted global health crisis could represent a total addressable market of more than $100 billion annually by 2030. Previous treatments for obesity have been limited by safety concerns and insufficient efficacy, which we believe hindered their success.…