Skye Bioscience Stock Price, News & Analysis

Skye Bioscience (Nasdaq: SKYE) has commented on Novo Nordisk's Phase 2a top-line data for monlunabant, a small-molecule oral CB1 inverse agonist. The study met its primary endpoint, showing at least 6% placebo-adjusted weight loss at 16 weeks. However, dose-dependent neuropsychiatric side effects were observed.

Skye highlights the advantages of their large-molecule CB1 inhibitor, nimacimab, over small-molecule approaches. Nimacimab has shown minimal brain accumulation in preclinical studies and no neuropsychiatric adverse events in Phase 1 trials. Skye believes nimacimab offers a potential safety advantage due to its peripheral restriction.

Skye's Phase 2 trial of nimacimab in obesity, launched in August 2024, is expected to report interim weight loss data in Q2 2025 and top-line data in Q4 2025. The company remains confident in nimacimab's development plan and its potential for a wider therapeutic index compared to small-molecule CB1 inhibitors.

Skye Bioscience (Nasdaq: SKYE) has appointed Dr. Puneet S. Arora as Chief Medical Officer. Dr. Arora, a board-certified physician in endocrinology, diabetes, and metabolism, brings over 15 years of experience in clinical trial design and execution. His appointment comes as Skye initiates its Phase 2 CBeyond™ obesity clinical trial for nimacimab, a differentiated CB1 inhibitor.

Dr. Arora's expertise in metabolic diseases and his track record in drug development are expected to be valuable assets for Skye. The company aims to leverage his knowledge to advance treatments that can significantly improve health outcomes, particularly in the field of obesity therapeutics.

In connection with Dr. Arora's appointment, Skye granted him a stock option to purchase 225,000 shares of common stock under the company's 2024 Inducement Equity Incentive Plan.

Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company focused on metabolic health, has announced its participation in three upcoming healthcare investment conferences in September 2024:

• Morgan Stanley conference on September 6 (1x1 meetings)
• Cantor Global Healthcare Conference on September 19 (presentation and 1x1 meetings)
• Bank of America World Medical Innovation Forum on September 24 (panel and 1x1 meetings)

These events provide Skye with opportunities to present its research and engage with investors. Webcasts of available presentations will be accessible on Skye's website, offering wider access to the company's updates and progress in the field of metabolic health therapeutics.

Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company focused on metabolic health, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Board of Directors granted a non-qualified stock option award to purchase 40,000 shares of common stock to a new non-executive employee under its 2024 Inducement Equity Incentive Plan.

The stock options have an exercise price of $5.28 per share, equal to the closing price of Skye's common stock on August 22, 2024. The shares will vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting in 36 monthly installments, subject to continued employment. This grant is part of Skye's strategy to attract new talent and align employee interests with company growth.

Skye Bioscience (Nasdaq: SKYE) has launched a Phase 2 clinical trial, CBeyond™, to evaluate its peripheral CB1 inhibitor, nimacimab, for weight loss in patients with obesity. The study will assess nimacimab's efficacy as a monotherapy and in combination with a GLP-1 receptor agonist (Wegovy®). Key aspects of the trial include:

- 120 patients across four treatment groups
- 26-week treatment period with 13-week follow-up
- Primary endpoint: weight loss comparison between nimacimab and placebo
- Secondary endpoints: safety, tolerability, and body composition changes
- Exploratory endpoints: metabolic parameters and sleep quality assessment

Skye aims to report interim data in Q2 2025 and final data in Q4 2025. The company believes nimacimab's unique biologic approach may offer improved safety and efficacy compared to small molecule CB1 inhibitors.

Skye Bioscience (NASDAQ: SKYE) reported Q2 2024 financial results and recent highlights. The company is advancing its nimacimab peripheral CB1 inhibitor for obesity, with a Phase 2 clinical trial expected to begin in Q3 2024. Key points include:

- CBeyond™ Phase 2 trial design announced, targeting 120 patients
- Collaboration with Beacon Biosignals for sleep quality assessment
- Discontinuation of glaucoma study and ophthalmology pipeline
- Appointment of new board member and Clinical and Scientific Advisory Board
- Uplisting to NASDAQ Global Market® and inclusion in Russell indexes
- Q2 2024 financials: $74.1M cash position, $4.1M R&D expenses, $4.3M G&A expenses, $7.9M net loss

Skye expects current cash to fund operations through at least H1 2027.

Skye Bioscience (Nasdaq: SKYE) is hosting a virtual KOL event on July 24, 2024, focusing on 'Metabolic Rewiring with CB1 Inhibition' and detailing its Phase 2 Nimacimab clinical trial design. The event will cover the current obesity treatment landscape, the potential role of peripheral CB1 inhibition, and preclinical and Phase 1 data on Nimacimab.

Key highlights of the CBeyond™ Phase 2 trial include:

• 120 patients across four treatment groups
• 26-week treatment period with 13-week safety follow-up
• Primary endpoint: weight loss evaluation
• Secondary endpoints: safety, metabolic parameters, body composition changes
• Exploratory endpoints: combination therapy evaluation, sleep improvement

Skye has also announced a collaboration with Beacon Biosignals to assess sleep quality and sleep apnea in the trial, using Beacon's FDA-cleared Dreem Headband for data collection.

Skye Bioscience (Nasdaq: SKYE) will host a virtual KOL event titled “Metabolic Rewiring with CB1 Inhibition” on July 24, 2024, at 9:00 AM ET. The event will feature prominent medical professionals like Dr. Louis J. Aronne, Dr. Marcus DaSilva Goncalves, Dr. Lee M. Kaplan, and Dr. Beverly Tchang. Discussions will include the current obesity treatment landscape and the role of peripheral CB1 inhibition. The event will highlight Skye's Nimacimab CB1 inhibitor, its clinical experiences, and the Phase 2 study design for using Nimacimab alone and with a GLP-1R agonist. Phase 2 trial dosing is set to commence in Q3 2024. Registration is required to participate, and a Q&A session will follow the presentations. A replay will be available for those unable to attend live.

Skye Bioscience (Nasdaq: SKYE) has established a Clinical and Scientific Advisory Board to support the development of Nimacimab, its lead candidate targeting obesity. The newly formed board comprises leading experts in obesity and metabolic medicine, who will provide strategic and scientific counsel. This initiative is set to bolster the Phase 2 trial of Nimacimab, a cannabinoid 1 (CB1) receptor inhibitor, expected to commence in Q3 2024. CEO Punit Dhillon highlighted the importance of this collaboration for advancing Skye's operations. Notable board members include Dr. Lee Kaplan, Dr. Louis Aronne, Dr. Rekha Kumar, Dr. Marcus DaSilva Goncalves, Dr. Beverly Tchang, Dr. Eduardo Muñoz, and Dr. Giovanni Appendino, each bringing significant expertise in obesity and metabolic research.