Summary of Skye Bioscience FY Conference Call Company Overview - **Company**: Skye Bioscience (NasdaqGM:SKYE) - **Focus**: Development of innovative therapeutics targeting obesity through a CB1 antibody approach Key Points and Arguments Pipeline and Development - Skye is in **Phase 2a** development for an obesity treatment using a **CB1 antibody**, which is a non-incretin target, contrasting with the dominant incretin class (GLP-1) in the market [2][3] - The clinical readout for the lead program is expected in **late Q3 to early Q4 2025** [2] - The company is also focused on **lifecycle management** of lead assets and improving the **target product profile (TPP)**, including exploring less frequent dosing options [3][32] Market Insights - The obesity treatment market is described as **heterogeneous**, indicating that a one-size-fits-all approach is ineffective [4] - Approximately **70% of patients** discontinue current obesity drugs within the first year, primarily due to tolerability issues [6] - Skye aims to address the **maintenance population** and those who discontinue other treatments due to side effects [5] Competitive Positioning - NEMAZENMEB is positioned to target patients who discontinue drugs like **Zepbound** or **Wegovy**, with a focus on **combination therapies** that could enhance weight loss outcomes [8][17] - The company anticipates achieving **5% to 8% weight loss** at 26 weeks in its proof of concept study, with a goal of demonstrating a clear separation from placebo [14][15] Mechanism of Action - NEMAZENMEB operates through a **peripheral-driven mechanism**, focusing on metabolic functions outside the brain, which is expected to regulate appetite and improve glucose metabolism [9][10] - Evidence suggests that NEMAZENMEB can positively influence **lipid metabolism** and reduce inflammation, which are critical factors in obesity management [11][12] Safety and Efficacy - Skye emphasizes the importance of **neuropsychiatric safety**, especially given past issues with similar drugs like rimonabant [19][20] - The company has established a robust safety profile with no reported neuropsychiatric adverse events in early trials [20][21] Financial Position - As of June 30, Skye reported a cash balance of **$48 million**, which is expected to fund operations until **Q1 2027** [31] - The company is committed to maintaining low general and administrative costs while focusing on development [33] Future Milestones - Key upcoming milestones include the **top-line data release** in late Q3 to early Q4 2025 and decisions regarding the **Phase 2b study** [37][38] - The company is also exploring broader applications of its CB1 pathway research, potentially addressing various comorbidities associated with obesity [27][28] Additional Important Insights - Skye is open to exploring **combination therapies** with existing GLP-1 drugs, aiming for a product that could be administered less frequently while maintaining efficacy [29] - The company recognizes the competitive landscape of obesity treatments and aims to differentiate itself through unique mechanisms and improved patient outcomes [25][26]