On Friday, Skye Bioscience, Inc. SKYE announced the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting.The study demonstrated that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity across multiple ascending dose cohorts.There were no serious adverse events, no discontinuations due to adverse events, and ...

SAN DIEGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting. The study demonstrated that nimacimab was safe, well-tol ...

PresentationFrank TangManaging Director Good morning, everyone. My name is Frank Tang, and I'm with the Investment Banking division at Morgan Stanley. Before we get started, I'd like to read a quick disclaimer. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, thank you all for joining us today for the fireside chat with Skye Bio ...

PresentationFrank TangManaging Director Good morning, everyone. My name is Frank Tang, and I'm with the Investment Banking division at Morgan Stanley. Before we get started, I'd like to read a quick disclaimer. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, thank you all for joining us today for the fireside chat with Skye Bio ...

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]

Skye Bioscience (SKYE) Update / Briefing September 04, 2025 08:00 AM ET Speaker0Good morning, and welcome to the Sky Bioscience expert panel. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations and fireside chat. If you'd like to submit a question, you may do so by using the Q and A text box at the bottom of the webcast player. As a reminder, this call is being recorded, a replay will be made available on the Sky Bioscience website follow ...

Skye shares new preclinical DIO data at virtual KOL eventNimacimab + tirzepatide demonstrates over 40% weight loss in multiple preclinical DIO studies Nimacimab demonstrates durable post-treatment weight loss compared to tirzepatideNimacimab reduced rebound weight gain following treatment with tirzepatide or nimacimab + tirzepatideNimacimab outperformed monlunabant head-to-head, and is uniquely positioned as a well-tolerated therapeutic to potentially induce healthier and sustained weight loss, both as a mo ...

SAN DIEGO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that the last patient has completed 26 weeks of treatment in the main study of its Phase 2a CBeyond™ clinical trial evaluating nimacimab, Skye’s peripherally-restricted CB1 inhibitor antibody, for the treatment of obesity and overweight. Skye expects to report topline ...

Core Insights - Skye Bioscience, Inc. will host a virtual KOL event on September 4, 2025, to discuss the upcoming topline results from the Phase 2a CBeyond™ trial of nimacimab, a first-in-class peripheral CB1 antibody for obesity [1][2] - The event aims to provide clarity on what constitutes success in the proof-of-concept study, focusing on safety, tolerability, and new preclinical insights related to nimacimab [2][7] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][8] - The company is conducting a Phase 2a clinical trial for nimacimab, which is designed to inhibit peripheral CB1 and is also assessing its combination with a GLP-1R agonist [8] KOL Event Highlights - The event will feature discussions with leading obesity experts, including Skye's CEO, Punit Dhillon, who will address the significance of safety and tolerability benchmarks in the obesity treatment landscape [2][7] - Key opinion leaders participating include Dr. Kevin Cannon, Dr. Sean Wharton, and Dr. Marcus Goncalves, who bring extensive experience in metabolic health and obesity research [3][4][6] Research Focus - The event will cover the mechanism and potential role of peripheral CB1 inhibition as a differentiated anti-obesity therapeutic pathway [7] - Newly generated preclinical data with nimacimab will be highlighted, contributing to the understanding of its potential advancement into Phase 2b development [2][7]

SAN DIEGO, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) ("Skye"), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that it will participate in the following upcoming investment and medical conferences: Investment Conferences Medical/Scientific Conferences Available webcasts will be accessible on Skye's website. About Skye Bioscience Skye is focused on unlocking new therapeutic path ...