Welcome to our dedicated page for Skye Bioscience news (Ticker: SKYE), a resource for investors and traders seeking the latest updates and insights on Skye Bioscience stock.
Skye Bioscience, Inc. (Nasdaq: SKYE) is a cutting-edge, clinical-stage biopharmaceutical company based in San Diego, California. Focused on the development of innovative therapies, Skye leverages the endocannabinoid system to address diseases characterized by metabolic, inflammatory, and fibrotic processes.
The company's prominent clinical candidates include nimacimab and SBI-100 Ophthalmic Emulsion (SBI-100 OE). Nimacimab is a groundbreaking humanized monoclonal antibody that functions as a negative allosteric modulator of the cannabinoid 1 receptor (CB1). By targeting CB1 in peripheral tissues, nimacimab aims to treat diseases like obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH) without the central nervous system (CNS) side effects that plagued earlier CB1 inhibitors. Currently, Skye is gearing up for a Phase 2 clinical trial of nimacimab in patients with obesity and chronic kidney disease, expected to begin in mid-2024.
Meanwhile, SBI-100 OE is under investigation for its potential to lower intraocular pressure in patients suffering from glaucoma and ocular hypertension. Although the Phase 2a trial did not meet its primary endpoint for reducing intraocular pressure, the drug demonstrated a favorable safety profile, paving the way for further research and development.
Recent news highlights Skye's strategic focus and financial stability. As of June 2024, the company announced the discontinuation of clinical development for SBI-100 OE, allowing Skye to redirect resources fully towards its metabolic program, extending its operational runway into 2027. Backed by leading life science venture investors, including Perceptive Advisors and 5AM Ventures, Skye successfully raised $90.25 million through two private placements in the first quarter of 2024, ensuring robust financial resources to support its ambitious clinical development plans.
For more information, please visit the company's website at www.skyebioscience.com.
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.
Skye Bioscience (Nasdaq: SKYE) has appointed Dr. Karen Smith to its Board of Directors, effective August 1, 2024. Dr. Smith brings over 20 years of global biotech and biopharma experience, enhancing Skye’s strategic focus on the Nimacimab metabolic program. The company is preparing for a Phase 2 clinical trial of Nimacimab, targeting obesity and related metabolic conditions. Alongside Dr. Smith's appointment, board members Keith Ward and Praveen Tyle will resign. Additionally, Skye has granted General Counsel Brennen Brodersen a stock option for 60,000 shares and 15,000 restricted stock units as part of the 2024 Inducement Equity Incentive Plan.
Skye Bioscience (Nasdaq: SKYE), a clinical-stage biotech firm, has been included in the Russell 2000® and Russell 3000® indexes, effective July 1, 2024. This inclusion is part of the annual Russell index reconstitution. The company, focusing on innovative therapeutic drugs targeting the endocannabinoid system, views this as a significant milestone that will boost its visibility among investors. CFO Kaitlyn Arsenault highlighted the importance of this achievement as the company progresses with its obesity program and prepares for a Phase 2 clinical trial of Nimacimab in Q3 2024. The Russell US Indexes reconstitution considers the top 4,000 US stocks based on market capitalization, making them key benchmarks for investment managers and institutional investors. As of December 2023, approximately $10.5 trillion in assets are benchmarked against these indexes.
Skye Bioscience, a clinical-stage biopharmaceutical company specializing in endocannabinoid system therapies, will participate in Piper Sandler's Virtual Obesity Day on June 26, 2024. This event, linked to the ADA 2024 Conference, features presentations by key opinion leaders and discussions with companies developing obesity treatments. Skye Bioscience's CEO Punit Dhillon, Chief Development Officer Tu Diep, and Chief Scientific Officer Chris Twitty will be part of a fireside chat from 11:30-11:55 a.m. ET. Piper Sandler clients can register through their representatives.
Skye Bioscience (Nasdaq: SKYE) announced the discontinuation of its SBI-100 Ophthalmic Emulsion (OE) program after it failed to meet the primary endpoint in a Phase 2a trial for glaucoma and ocular hypertension. The study, involving 56 patients, found no statistically significant improvement in intraocular pressure compared to placebo. Consequently, Skye will terminate all R&D related to SBI-100 OE and divert resources to its metabolic program. The company plans to initiate a Phase 2 obesity trial for its CB1 inhibitor, Nimacimab, in Q3 2024 and expects its cash runway to extend into 2027.
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