Fannie Mae, Freddie Mac shares tumble after conservatorship comments
SAN DIEGO - Skye Bioscience, Inc. (NASDAQ:SKYE), a clinical-stage biopharmaceutical company, announced its large-molecule CB1 inhibitor, nimacimab, showed minimal brain accumulation and no neuropsychiatric side effects in Phase 1 trials. This update follows recent Phase 2a data from Novo Nordisk (NYSE:NVO)'s small-molecule CB1 inhibitor, monlunabant, which demonstrated weight loss but with neuropsychiatric side effects.
Skye's CEO, Punit Dhillon, stated that the results from Novo Nordisk's monlunabant are supportive of CB1 receptor inhibition's role in weight loss. However, he highlighted the safety distinction between Skye's nimacimab and small-molecule CB1 inhibitors, emphasizing nimacimab's minimal brain drug accumulation in preclinical studies and lack of neuropsychiatric adverse events in Phase 1 trials for non-alcoholic fatty liver disease (NAFLD).
Chief Scientific Officer Chris Twitty provided further insights, explaining that pharmacodynamic models predict nimacimab has sufficient peripheral exposure to inhibit CB1 signaling without significant brain exposure, potentially reducing the risk of neuropsychiatric side effects.
Skye launched a Phase 2 trial of nimacimab in obesity in August 2024, which also assesses a combination with a GLP-1/CB1 inhibitor. Interim weight loss data is expected in Q2 2025, with top-line data anticipated in Q4 2025.
The company's data suggest nimacimab could offer a wider therapeutic index compared to small-molecule CB1 inhibitors, allowing for higher dosing with less risk of central nervous system side effects. Skye also plans to share results from a murine mouse model study evaluating nimacimab's effects on weight loss in the near future.
Skye Bioscience is focused on metabolic health therapeutics, modulating G-protein coupled receptors to develop first-in-class drugs with clinical and commercial differentiation. Nimacimab is a humanized monoclonal antibody targeting CB1 signaling in the periphery with potential applications in obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH).
This announcement is based on a press release statement by Skye Bioscience and reflects the company's current expectations and projections regarding nimacimab's development and therapeutic potential.
In other recent news, Skye Bioscience has been making notable strides in its operations. The company's novel CB1 inhibiting antibody, nimacimab, is currently being evaluated in a Phase II CBeyond study for its efficacy in treating obesity. Analyst firms JMP Securities, Piper Sandler, Craig-Hallum, and Oppenheimer have all maintained positive ratings on Skye Bioscience, reflecting confidence in the company's prospects. The company recently appointed Dr. Puneet S. Arora as its new Chief Medical Officer, bringing extensive experience in clinical trials and regulatory submissions. Additionally, Skye Bioscience has partnered with Beacon Biosignals to incorporate sleep-related assessments into the CBeyond trial, given the link between obesity and sleep disorders. The company has also expanded its board with the appointment of Karen Smith, MD, Ph.D., MBA, LLM. Interim data from the Phase 2 trial of nimacimab is expected in the second quarter of 2025. These recent developments highlight Skye Bioscience's commitment to creating treatments that could potentially offer better outcomes for patients struggling with obesity.
InvestingPro Insights
As Skye Bioscience, Inc. (NASDAQ:SKYE) progresses with its clinical trials for nimacimab, investors are closely monitoring the company's financial health and stock performance. According to recent data from InvestingPro, Skye's operating income, EBIT, and EBITDA for the last twelve months as of Q2 2024 stand at a negative $22.14 million, -$22.14 million, and -$22.02 million, respectively. These figures underscore the company's current lack of profitability, which is in line with analysts' expectations that Skye will not be profitable this year.
InvestingPro Tips reveal that Skye's stock has faced significant challenges, with a 1-week price total return of -45.86% and a 1-month price total return of -47.23%. The 3-month and 6-month returns have also been negative, at -59.59% and -73.83%, respectively. Despite these setbacks, year-to-date performance shows a positive return of 15.44%, suggesting some recent recovery. However, it is worth noting that the company has not been profitable over the last twelve months and does not pay a dividend to shareholders, which may concern income-focused investors.
Investors should also be aware 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 as it continues to invest in its clinical pipeline.
For those considering an investment in Skye Bioscience, it is important to stay informed about the company's financial metrics and stock volatility. Additional InvestingPro Tips, which could further guide investment decisions, are available on the InvestingPro platform, including 12 more tips specific to Skye Bioscience.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.