Skye Bioscience, Inc. - SKYE STOCK NEWS

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.

01/29/2024 08:00 AM

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Skye Bioscience Announces $50.25 Million Private Placement Equity Financing

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Skye Bioscience, Inc. has announced a securities purchase agreement for the sale of common stock and pre-funded warrants, with gross proceeds of $50.25 million from a PIPE financing co-led by a life sciences-focused investor and 5AM Ventures. The financing is expected to fund operations into early 2026, including Phase 2 clinical trials for nimacimab in obesity and SBI-100 OE in glaucoma and ocular hypertension. The company is also planning a Phase 2 trial randomizing obese patients to test the efficacy of nimacimab and GLP-1R agonist in weight loss. Skye's CEO, Punit Dhillon, expressed optimism about the potential impact of CB1-modulating therapies in treating obesity and glaucoma, emphasizing the scientific validation of nimacimab's mechanism of action and the need for alternative intraocular pressure-lowering drugs.

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01/09/2024 07:00 AM

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Skye Bioscience Receives IND Clearance for Phase 2 Clinical Trial of Nimacimab in Obesity and Chronic Kidney Disease

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Skye Bioscience, Inc. (SKYE) receives FDA clearance to initiate Phase 2 clinical trial of nimacimab, a peripherally-acting CB1 inhibitor, targeting obesity and chronic kidney disease. Nimacimab shows promising safety and tolerability in Phase 1b study, with encouraging trends in exploratory biomarkers. The molecule offers potential as a single or combination therapy for metabolic conditions.

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12/11/2023 07:00 AM

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Skye Announces Clinical Development Plan in Obesity for Differentiated Peripheral CB1 Inhibitor, Nimacimab

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Skye Bioscience, Inc. (SKYE) plans to develop nimacimab, a monoclonal antibody targeting the endocannabinoid system, for weight loss and obesity treatment. The Company filed an IND application with the FDA for a Phase 2 study in patients with obesity and chronic kidney disease. Nimacimab's safety profile is encouraging, showing potential for monthly dosing and convenient patient self-administration.

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12/08/2023 05:14 PM

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Skye Bioscience Responds to OTC Markets Promotional Policy

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Skye Bioscience, Inc. (OTCQB: SKYE) Receives Request from OTC Markets Group Inc. for Statement

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12/05/2023 07:00 AM

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Skye Bioscience and Tautomer Bioscience Enter Exclusive License for SBI-100 for Development and Sale of Products for Chronic Pain and Other Indications in South Africa and Rest of Africa

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Skye Bioscience, Inc. (OTCQB: SKYE) and Tautomer Bioscience (Pty) Limited have announced an agreement granting Tautomer an exclusive license to develop and commercialize Skye's proprietary THC prodrug, SBI-100, as a novel suppository application for chronic intractable pain and other indications in South Africa and the rest of Africa. The agreement includes development milestones, sales milestones, and tiered double-digit royalties on net product sales. Tautomer will also purchase Skye shares in open market transactions. This partnership aims to address the unmet medical need for non-opioid alternatives for chronic pain in South Africa.

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11/28/2023 07:00 AM

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Skye Bioscience Treats First Patient in Glaucoma Phase 2 Study of SBI-100 Ophthalmic Emulsion

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Skye Bioscience, Inc. (SKYE) has treated the first patient in its Phase 2 clinical trial evaluating SBI-100 Ophthalmic Emulsion’s ability to lower intraocular pressure, safety, and relevant biomarkers in patients with primary open-angle glaucoma or ocular hypertension. The Phase 2 study will compare two concentrations of SBI-100 OE vs. placebo, dosing twice a day for 14 days, with analysis of IOP data from 50% of patients enrolled to be performed in Q1 2024.

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11/21/2023 07:00 AM

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Skye Bioscience to Present at BTIG Ophthalmology Day and OIS XIII Ophthalmology Innovation Summit

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Skye Bioscience, Inc. (SKYE) to present its glaucoma program at two ophthalmology-focused conferences, showcasing SBI-100 Ophthalmic Emulsion, a first-in-class CB1 agonist. The company will introduce recent Phase 1 data and discuss details of its Phase 2a clinical study. Executives will be available for 1x1 meetings at the BTIG 3rd Annual Ophthalmology Day and OIS XIII Ophthalmology Innovation Summit.

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10/25/2023 07:00 AM

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Skye Bioscience Announces Positive Phase 1 Trial Results for SBI-100 Ophthalmic Emulsion, Its First-in-Class CB1 Agonist Being Developed for the Treatment of Glaucoma

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Skye Bioscience reports successful results from Phase 1 trial of SBI-100 OE, an ophthalmic drug targeting glaucoma

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09/07/2023 01:00 PM

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Skye Bioscience Reverse Stock Split to Be Effective on September 8th

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Skye Bioscience, Inc. announces 1-for-250 reverse stock split effective September 8th. Total issued and outstanding shares will be approximately 12,312,551. No fractional shares will be issued. Stockholders' ownership interest and voting power remain virtually unchanged.

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09/05/2023 07:00 AM

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Skye Bioscience to Present at H.C. Wainwright 25th Annual Global Investment Conference

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Skye Bioscience to present company overview at H.C. Wainwright 25th 3rd Annual Global Investment Conference

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FAQ

What is the current stock price of Skye Bioscience (SKYE)?

The current stock price of Skye Bioscience (SKYE) is $2.61 as of January 23, 2025.

What is the market cap of Skye Bioscience (SKYE)?

The market cap of Skye Bioscience (SKYE) is approximately 75.5M.

What does Skye Bioscience, Inc. specialize in?

Skye Bioscience specializes in developing novel therapies targeting the endocannabinoid system to treat diseases with metabolic, inflammatory, and fibrotic processes.

What are the main clinical candidates for Skye Bioscience?

The main clinical candidates are nimacimab, a monoclonal antibody targeting peripheral CB1 receptors, and SBI-100 Ophthalmic Emulsion, currently under investigation for glaucoma and ocular hypertension.

What recent financial developments has Skye Bioscience announced?

In the first quarter of 2024, Skye raised $90.25 million through two private placements, ensuring financial stability for its ongoing and upcoming clinical trials.

What is the status of Skye Bioscience's SBI-100 Ophthalmic Emulsion?

The Phase 2a trial did not meet its primary endpoint for lowering intraocular pressure, leading Skye to discontinue further development of SBI-100 OE.

When is the Phase 2 clinical trial for nimacimab expected to start?

The Phase 2 clinical trial for nimacimab is expected to begin dosing in mid-2024.

What diseases does nimacimab target?

Nimacimab targets diseases such as obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH) by inhibiting peripheral CB1 receptors.

Who are Skye Bioscience's key investors?

Key investors include Perceptive Advisors, 5AM Ventures, Velan Capital, and Schonfeld Strategic Advisors, among others.

What is Skye Bioscience's strategy for clinical development?

Skye focuses on leveraging biologic targets with substantial human proof of mechanism to develop first-in-class therapeutics with significant clinical and commercial differentiation.