Skye Bioscience Stock Price, News & Analysis

Skye Bioscience (NASDAQ: SKYE) reported Q3 2025 results and clinical updates on nimacimab for obesity. Topline CBeyond Phase 2a data showed a 29% relative increase in weight loss for nimacimab plus semaglutide versus semaglutide alone at 26 weeks, an additional -3.2 cm waist circumference reduction, and lower rebound weight gain (18.1% vs. 49.8%) over 12 weeks post-treatment. The combination showed a clean neuropsychiatric safety profile and no increase in GI adverse events. A 26-week extension is fully enrolled (43 patients) with data expected in Q1 2026. Cash, cash equivalents and short-term investments were $35.3M as of Sept 30, 2025, funding operations into 2027. Q3 net loss was $12.8M.

Skye Bioscience (Nasdaq: SKYE) will present a late-breaking oral abstract at ObesityWeek 2025 on November 7, 2025 summarizing topline CBeyond™ Phase 2 data.

Key findings: nimacimab 200 mg weekly plus semaglutide blunted 12-week post-treatment weight regain (18.1% vs 49.8%), maintained significant weight loss vs placebo at 12 weeks post-treatment (p=0.006), and previously produced additional on‑treatment weight loss (-13.2% vs -10.25%, p=0.0372). Waist circumference improved by 3.17 cm more versus semaglutide alone (p=0.0492). Presentation: Dr. Louis Aronne, Nov 7, 2025, 9:15–9:30am EDT, GWCC-A411-A412.

Skye Bioscience (Nasdaq: SKYE) will report third quarter 2025 financial results and host a business update call on November 10, 2025 at 1:30 p.m. PT / 4:30 p.m. ET.

The company will issue its earnings press release and financial tables after market close on November 10, 2025. A live webcast and investor presentation will be available on the Skye Investor Relations website, with a replay posted after the call.

Skye will also present at the Stifel 2025 Healthcare Conference in New York on November 13, 2025 from 4:40–5:10 PM and will be available for one‑on‑one meetings.

Skye Bioscience (NASDAQ: SKYE) reported topline 26‑week Phase 2a CBeyond™ results for nimacimab. Monotherapy at 200 mg did not meet the primary endpoint (least‑squares mean -1.52% vs -0.26% placebo, p=0.2699) and showed lower‑than‑expected exposure on preliminary PK analysis, supporting evaluation of higher dosing. The nimacimab 200 mg + semaglutide arm showed additional weight loss versus semaglutide alone (-13.2% vs -10.25%, p=0.0372) with no increase in GI or neuropsychiatric adverse events. Extension data expected Q1 2026; detailed 26‑week results to be presented at ObesityWeek in November.

Skye Bioscience (NASDAQ:SKYE) presented Phase 1b study results for nimacimab, their peripheral CB1-inhibiting antibody, at the EASD Annual Meeting. The study, conducted in subjects with metabolic-associated steatotic liver disease (MASLD), demonstrated favorable safety and tolerability profiles.

Key findings include no serious adverse events, no discontinuations due to adverse events, and notably, no neuropsychiatric safety signals. The drug showed predictable pharmacokinetics, low immunogenicity, and only mild, infrequent gastrointestinal side effects across multiple ascending dose cohorts.

The study, originally conducted by Bird Rock Bio (acquired by Skye in 2023), supports nimacimab's potential role in treating metabolic diseases, with the company awaiting topline results from their CBeyond™ Phase 2a obesity study.

Skye Bioscience (NASDAQ:SKYE) reported promising preclinical data for its CB1 inhibitor nimacimab in diet-induced obesity (DIO) mouse studies. The drug demonstrated superior weight loss efficacy compared to monlunabant and enhanced results when combined with tirzepatide, achieving over 40% weight loss.

Key findings show nimacimab's differentiation as a peripherally-restricted CB1 inhibitor with potential superior safety profile, ability to reduce post-treatment weight rebound by over 50%, and enhanced efficacy when combined with both low and high-dose tirzepatide. The company expects to report top-line Phase 2 CBeyond™ study data in late Q3/early Q4 2025.

Skye Bioscience (Nasdaq: SKYE) has announced the completion of the 26-week treatment phase in its Phase 2a CBeyond™ clinical trial evaluating nimacimab, a peripherally-restricted CB1 inhibitor antibody for obesity treatment. The study's primary endpoint will assess weight loss changes between nimacimab and placebo, with an exploratory arm examining the combination with semaglutide (Wegovy®).

The company has also completed enrollment for a 26-week extension study, which will provide data for a total treatment duration of 52 weeks, followed by a 13-week follow-up period. Topline data from the initial phase is expected in late Q3/early Q4 2025, while extension study results are anticipated in Q1 2026.

Skye Bioscience (NASDAQ:SKYE) has announced a virtual KOL event scheduled for September 4, 2025, at 8:00 AM ET. The event, titled "Expert Panel on Peripheral CB1 Inhibition as a Mechanism for Weight Loss," will focus on the upcoming topline results from the Phase 2a CBeyond™ trial of nimacimab, their first-in-class peripheral CB1 antibody for obesity treatment.

The event will feature distinguished obesity experts including Dr. Kevin Cannon, Dr. Sean Wharton, and Dr. Marcus Goncalves. Key discussion topics will include success criteria for the Phase 2a study, mechanism of peripheral CB1 inhibition, new preclinical data, and safety considerations including gastrointestinal and neuropsychiatric outcomes. While no clinical results will be previewed, the event aims to provide context for interpreting the upcoming data readout and nimacimab's potential role in obesity treatment.

Skye Bioscience (Nasdaq: SKYE), a clinical-stage biotech company focused on obesity and metabolic health disorders, has announced its participation in multiple upcoming conferences in September 2025.

The company will present at three major investment conferences: the Cantor Global Healthcare Conference (Sept. 5), the H.C. Wainwright Global Investment Conference (Sept. 8), and the Morgan Stanley Global Healthcare Conference (Sept. 10). Additionally, Skye will participate in two medical conferences: Obesity Science & Innovation in Boston and the EASD Annual Meeting in Vienna, where they will present data on nimacimab, their CB1 receptor antibody for MAFLD treatment.