Skye confirms phase 2 data on nimacimab for obesity expected later this year

[Obesity card in hands of Medical Doctor] Michail_Petrov-96/iStock via Getty Images Phase 2a data on Skye Bioscience's (NASDAQ:SKYE [https://seekingalpha.com/symbol/SKYE]) cannabinoid-1 receptor blocker (CB1) for obesity, nimacimab, should be released in late Q3 or early Q4, the company's CEO confirmed to Seeking Alpha. In its Q1 earnings call [https://seekingalpha.com/article/4784689-skye-bioscience-inc-skye-q1-2025-earnings-call-transcript] in May, Punit Dhillon said that top-line weight loss data from a 26-week primary analysis of the CBeyond study would be out then. Speaking to Seeking Alpha on the sidelines of the BIO International Convention in Boston, Dhillon explained how nimacimab could be an alternative or even complementary to GLP-1s currently dominating the weight loss space from pharma giants Novo Nordisk (NVO [https://seekingalpha.com/symbol/NVO]) and Eli Lilly (NYSE:LLY [https://seekingalpha.com/symbol/LLY]). Nimacimab is also under investigation in combination with Novo's semaglutide, the active ingredient in Wegovy for weight loss and Ozempic for type 2 diabetes. Nimacimab is not the first CB1 inhibitor for obesity.

Monlunabant, a small molecule developed by Inversago Pharma and eventually acquired by Novo, showed modest weight loss, but also came with reports of mild to moderate neuropsychiatric events. Rimonabant, another oral CB1 inhibitor, was developed by Sanofi (SNY [https://seekingalpha.com/symbol/SNY]) and approved in Europe, but was eventually withdrawn due to a high number of neuropsychiatric side effects. Dhillon said that data so far on nimacimab, a large molecule, monoclonal antibody, avoids the neuropsychiatric events that have plagued oral CB1s in the past because the asset doesn't target receptors in the brain. Instead, nimacimab is focused on blocking peripheral CB1 signaling, aiming to block that. Organs with a high number of CB1 ligands -- activators -- such as the kidneys, liver, and pancreas, as well as adipose tissue and the digestive system can lead to inflammation and metabolic dysfunction if CB1 ligands are activated.

One of the drawbacks of GLP-1s, according to Dhillon, is the high discontinuation rates, mainly because of gastrointestinal side effects. He contended that nearly two-thirds of individuals on these drugs stop using them within a year. "If you can have weight loss with minimal side effects, we believe that can be super beneficial." Another advantage nimacimab could provide, said Dhillon, is that it is only targeting fat, meaning it can help preserve lean muscle mass and minimize muscle wasting. Although a monoclonal antibody, Dhillon noted that nimacimab is administered through subcutaneous injection. As far as capital, he added that the company has enough cash for a "one-year plus cushion," though for phase 3, "we believe a larger partner could help us ramp up faster." MORE ON SKYE BIOSCIENCE * Skye Bioscience, Inc.

(SKYE) Q1 2025 Earnings Call Transcript [https://seekingalpha.com/article/4784689-skye-bioscience-inc-skye-q1-2025-earnings-call-transcript] * Skye Bioscience, Inc. 2025 Q1 - Results - Earnings Call Presentation [https://seekingalpha.com/article/4784590-skye-bioscience-inc-2025-q1-results-earnings-call-presentation] * A Weight Loss Drug Candidate Essentially For Free As Skye Bioscience Is Trading At Cash Value [https://seekingalpha.com/article/4775517-a-weight-loss-drug-candidate-essentially-for-free-as-sky-bioscience-is-trading-at-cash-value] * Skye Bioscience GAAP EPS of -$0.28 beats by $0.01 [https://seekingalpha.com/news/4445245-skye-bioscience-gaap-eps-of-0_28-beats-by-0_01] * Seeking Alpha’s Quant Rating on Skye Bioscience [https://seekingalpha.com/symbol/SKYE/ratings/quant-ratings]