SAN DIEGO - Skye Bioscience, Inc. (NASDAQ:SKYE), a clinical-stage biopharmaceutical company, has initiated patient screening for a Phase 2 clinical trial of nimacimab, its novel peripheral CB1 inhibitor aimed at weight loss in obese patients. The study, named CBeyondTM, will evaluate nimacimab's efficacy and safety, focusing on gastrointestinal tolerability and lean mass retention—key factors in sustainable weight loss.
Nimacimab, a negative allosteric modulating antibody, represents a potential new class of weight loss therapeutics. The drug's development comes amid a search for alternatives to existing GLP-1 and GIP drugs, with an emphasis on improved health outcomes. Skye's CEO, Punit Dhillon, expressed optimism about nimacimab's attributes, which may contribute to better weight management solutions.
The trial will enroll 120 patients across four groups, with 80 receiving nimacimab or a placebo, and the remaining 40 receiving nimacimab in combination with the GLP-1 drug Wegovy® or a placebo. Wegovy® will be administered according to its prescribing information. The primary endpoint is the evaluation of weight loss in the nimacimab arm versus placebo, with secondary endpoints including safety, tolerability, and neuropsychiatric and cognitive evaluations.
Skye Bioscience emphasizes that nimacimab's safety profile may offer a competitive advantage over small molecule CB1 inhibitors, as it is more restricted from the brain, potentially reducing the risk of psychiatric adverse events. This claim is supported by the absence of such events in preclinical studies and a Phase 1 trial in patients with nonalcoholic fatty liver disease (NAFLD).
The design of the CBeyondTM trial includes a 26-week treatment period and a subsequent 13-week evaluation. Interim data is expected in Q2 of 2025, with final data anticipated in Q4 of 2025.
The study will also explore the impact of nimacimab on sleep quality in a subset of patients, using advanced sleep monitoring technology. This is particularly relevant as obesity is a major risk factor for conditions like sleep apnea, which can disrupt sleep patterns.
This clinical trial is being conducted at 18 U.S. sites, and Skye Bioscience has excluded patients with diabetes from participation. The information presented is based on a press release statement from Skye Bioscience.
In other recent news, Skye Bioscience has announced a strategic partnership with Beacon Biosignals to integrate sleep-related assessments into the CBEYOND™ Phase 2 clinical trial for the investigational drug Nimacimab. Skye Bioscience also formed a clinical advisory board to guide the development of Nimacimab, which is being studied for its potential benefits in treating obesity and related cardiometabolic diseases. Craig-Hallum initiated a Buy rating on Skye Bioscience, highlighting the potential of Nimacimab in addressing obesity.
The company has expanded its board with the appointment of Karen Smith, MD, Ph.D., MBA, LLM, and announced the upcoming launch of a Phase 2 clinical trial for Nimacimab. Skye Bioscience has also been included in the Russell 2000® and Russell 3000® indexes, enhancing its visibility among investors.
Oppenheimer, Cantor Fitzgerald, and Piper Sandler have adjusted their ratings and price targets for Skye Bioscience following the company's decision to discontinue its SBI-100 Ophthalmic Emulsion program and focus on the advancement of Nimacimab. The company has secured $40 million in gross proceeds through a private placement deal to support its upcoming Phase 2 clinical trials. These are recent developments in Skye Bioscience's operations.
InvestingPro Insights
As Skye Bioscience advances its Phase 2 clinical trial for nimacimab, investors are closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, Skye's financial metrics reveal a challenging landscape. The company's EBITDA for the last twelve months as of Q2 2024 stands at a negative $22.02 million, indicating that Skye is currently not generating positive earnings before interest, taxes, depreciation, and amortization. Furthermore, both basic and diluted EPS (Earnings Per Share) from continuing operations are negative, at -$1.94 and -$1.95 respectively, underscoring the company's lack of profitability during this period.
Despite these financial hurdles, Skye's stock has experienced a significant return over the last year, with a year-to-date price total return of 101.84% and a one-year price total return of 99.64%. This reflects substantial investor optimism, possibly due to the potential market for obesity treatments and the innovative nature of nimacimab. However, the stock's price has seen considerable volatility, with a three-month price total return showing a steep decline of 54.17%.
InvestingPro Tips highlight that Skye operates with a moderate level of debt and has liquid assets that exceed its short-term obligations, which may provide some financial flexibility in the near term. However, analysts have revised their earnings estimates downwards for the upcoming period, and they do not anticipate the company will be profitable this year. With these financial considerations in mind, investors can find additional insights and tips, including the company's weak gross profit margins and stock price volatility, on the InvestingPro platform, which lists a total of 12 InvestingPro Tips for Skye Bioscience.
For those interested in a deeper dive into Skye's financial health and market potential, the full suite of InvestingPro Tips can be found at https://www.investing.com/pro/SKYE, offering valuable guidance for making informed investment decisions.
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