SAN DIEGO - Skye Bioscience Inc. (NASDAQ:SKYE), a biotech company specializing in endocannabinoid system therapeutics, has announced the establishment of a clinical advisory board (CAB) composed of leading experts in metabolic diseases, particularly obesity. The CAB's role will be to guide the development of the company's primary drug candidate, Nimacimab, which is slated to begin Phase 2 trials for obesity treatment later this quarter.
The newly formed CAB includes distinguished academics and clinicians such as Lee Kaplan, MD, Ph.D., Louis Aronne, MD, Rekha Kumar, MD, M.S., Marcus DaSilva Goncalves, MD, Ph.D., Beverly Tchang, MD, Eduardo Muñoz, MD, Ph.D., and Giovanni Appendino, Ph.D. Their collective expertise spans various aspects of obesity medicine, endocrinology, and metabolic research.
Nimacimab, a humanized monoclonal antibody, functions as a negative allosteric modulator that inhibits CB1 signaling. This inhibition has been associated with anti-fibrotic, anti-inflammatory, and metabolic benefits, offering a potential new approach to treating a range of diseases with significant unmet medical needs, including obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH).
Punit Dhillon, CEO and Chairman of Skye, expressed gratitude for the opportunity to collaborate with the obesity experts, emphasizing their scientific and clinical expertise would be vital in strategically supporting Skye's expansion and the upcoming clinical trial.
The formation of the CAB and the progression of Nimacimab into Phase 2 trials reflect Skye's commitment to addressing diseases with metabolic, inflammatory, and fibrotic processes. The company's strategy focuses on leveraging biological targets with substantial human proof of mechanism to develop first-in-class therapeutics with notable clinical and commercial differentiation.
In other recent news, Skye Bioscience has been making significant strides in its clinical trials and board appointments. The company received a Buy rating from Craig-Hallum, highlighting the potential of its lead product, nimacimab, in addressing obesity.
The firm anticipates that upcoming Phase II data for nimacimab will drive share appreciation. Skye Bioscience has also expanded its board with the appointment of Karen Smith, MD, Ph.D., MBA, LLM.
However, the company has decided to discontinue its SBI-100 Ophthalmic Emulsion program following an unsuccessful Phase 2a clinical trial. As a result, the focus has shifted towards the advancement of Nimacimab, a decision supported by Oppenheimer, Cantor Fitzgerald, and Piper Sandler. The analysts' firms have adjusted their ratings and price targets for Skye Bioscience accordingly.
Furthermore, Skye Bioscience has secured $40 million in gross proceeds through a private placement deal to support its upcoming Phase 2 clinical trials. The company has also been included in the Russell 2000® and Russell 3000® indexes, enhancing its visibility among investors.
InvestingPro Insights
As Skye Bioscience (NASDAQ:SKYE) gears up for Phase 2 trials of its primary drug candidate, Nimacimab, investors and stakeholders are closely watching the company's financial health and stock performance. Here are some insights from InvestingPro that may shed light on the company's current market position:
InvestingPro Data reveals that Skye's Price / Book ratio as of Q1 2024 stands at 4.32, which could suggest the market values the company higher than its net asset value, potentially due to the promising prospects of its drug candidate. Additionally, the company's one-week and one-month total price returns have seen significant declines of -18.36% and -40.47%, respectively, indicating recent market volatility and investor sentiment shifts.
Amidst this context, an InvestingPro Tip highlights that Skye holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability as it moves forward with clinical trials. However, the same set of InvestingPro Tips also notes that the company is not expected to be profitable this year, and analysts have concerns about weak gross profit margins.
For investors seeking a more comprehensive analysis, there are 12 additional InvestingPro Tips available for Skye Bioscience, which can be accessed at https://www.investing.com/pro/SKYE. These tips provide deeper insights into the company's financials, stock performance, and market outlook. For those interested in a subscription, use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, offering a valuable resource for informed investment decisions.
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