Welcome to our dedicated page for Skye Bioscience news (Ticker: SKYE), a resource for investors and traders seeking the latest updates and insights on Skye Bioscience stock.
Skye Bioscience, Inc. reports clinical-stage biotechnology developments focused on metabolic health disorders, obesity and overweight. The company's lead program, nimacimab, is a peripherally restricted monoclonal antibody inhibitor of the CB1 receptor being evaluated in the CBeyond Phase 2a program, including monotherapy and combination work with GLP-1 or other incretin-based therapies.
Recurring updates cover clinical data from CBeyond, higher-dose safety and pharmacokinetic work, regulatory feedback on follow-on trial design, manufacturing and formulation activities, scientific conference presentations, financial results and corporate outlooks. Skye also discusses its broader strategy of developing molecules that modulate G-protein-coupled receptors.
Skye Bioscience (Nasdaq: SKYE) reported Q1 2026 results and a business update focused on its nimacimab obesity program.
The CBeyond™ Expansion Study (Part C) has begun with Cohort 1, a Cohort Review Committee meeting on May 18, 2026, and topline data expected in Q4 2026.
Previously reported data showed nimacimab plus semaglutide achieving 22.3% mean weight loss at 52 weeks and favorable tolerability. Cash, cash equivalents and short-term investments were $17.1 million, expected to fund operations and key milestones through Q4 2026, excluding proposed Phase 2b trial and related manufacturing costs.
Skye Bioscience (Nasdaq: SKYE) reported Q1 2026 results and advanced its nimacimab obesity program.
Cash, equivalents and short-term investments were $17.1 million, expected to fund operations and key milestones through Q4 2026, excluding proposed Phase 2b clinical and additional manufacturing costs.
CBeyond™ Part C began, with topline data expected in Q4 2026, and prior data showed an approximately 3% incremental weight-loss benefit and 22.3% mean weight loss for nimacimab plus semaglutide, with favorable tolerability. Q1 R&D expenses were $7.9 million, G&A $4.7 million, and net loss $12.5 million.
Skye Bioscience (Nasdaq: SKYE) will present at the GLP-1-Based Therapeutics Summit in Boston, April 14–16, 2026.
The company’s presentation, titled "Maximizing Efficacy, Minimizing Risk by Leveraging Peripheral CB1 Antagonism in Combination with GLP-1 Agonists to Advance the Obesity Treatment Paradigm," will be delivered by President & CEO Punit Dhillon on April 16 at 1:30 pm.
Skye Bioscience (Nasdaq: SKYE) treated the first patient in Part C of the CBeyond Phase 2a expansion testing higher-dose nimacimab (400 mg IV and 600 mg IV weekly) versus placebo over 16 doses with a 12-week follow-up. Topline safety and PK data are expected in Q4 2026.
The study randomizes 8 participants per cohort in a 3:1 ratio, links IV doses to ~700 mg and ~1,000 mg SC equivalents, and requires a cohort safety review before enrolling the 600 mg group. The company received FDA Type C feedback and will use Part C data to inform Phase 2b dose selection.
Skye Bioscience (NASDAQ: SKYE) reported Q4 and full-year 2025 results and updated clinical progress for nimacimab. Key updates include initiation of a 400 mg and 600 mg IV Expansion Study, FDA Type C meeting minutes received, interim 22.3% 52-week weight loss with nimacimab+semaglutide, and cash of $25.7M supporting operations into Q4 2026.
Topline Expansion Study results are expected in Q4 2026 and Phase 2b protocol finalization is planned for Q4 2026.
Skye Bioscience (Nasdaq: SKYE) will report 2025 fourth-quarter and full-year financial results and provide a business update on March 10, 2026. A press release will be issued after market close, followed by a conference call at 1:30 p.m. PT / 4:30 p.m. ET.
Investors can access a live webcast, financial tables, and an investor presentation on Skye's Investor Relations website; a replay and transcript will be posted after the call.
Skye (Nasdaq: SKYE) reported interim 52-week data from the Phase 2a CBeyond extension showing 22.3% mean weight loss with nimacimab (200 mg dose) plus semaglutide (2.4 mg) and no plateau observed. The combination reduced weight regain during a 13-week off-therapy period to 17.8% versus 37.3% for semaglutide alone. Safety remained favorable with no serious adverse events or adverse events of special interest reported. The extension enrolled 19 combination-arm participants; seven completed the full 52-week combination treatment. Full topline extension reporting, including monotherapy and follow-up, is expected in Q3 2026.
Skye Bioscience (Nasdaq: SKYE) presented preclinical data on nimacimab, a peripherally-restricted CB1-inhibitor antibody, at the Keystone Obesity conference on January 29, 2026. Key DIO mouse-model findings: nimacimab added to tirzepatide produced 39% and 46% weight loss, effects were durable after discontinuation, rebound was blunted by ~80%, and weight loss was not driven primarily by caloric restriction. Nimacimab also enhanced semaglutide-induced weight loss, suggesting potential as a maintenance or combination therapy to support efficacy with lower incretin doses.
Skye Bioscience (Nasdaq: SKYE) will present a poster at the Keystone Obesity conference on Jan 28, 2026 addressing nimacimab, a peripherally‑restricted CB1‑inhibitor antibody, in diet induced obesity models.
Presentation covers nimacimab alone, combined with tirzepatide, durability after treatment stop, maintenance use post‑tirzepatide, and role of caloric restriction. Presenting author: Chris Twitty, PhD. Poster session 2, poster number 2020, at 7:30 PM.
Skye (Nasdaq: SKYE) provided its 2026 corporate outlook focused on advancing nimacimab, a peripherally restricted CB1‑inhibiting antibody for obesity and metabolic disorders. Key near‑term milestones include a CBeyond Phase 2a 26‑week extension interim update expected Q1 2026, topline 52‑week results (with a 13‑week off‑therapy follow‑up) expected Q3 2026, and a target to initiate an adaptive Phase 2b study in Q3 2026 after finalizing the plan and a Type C meeting in Q1 2026. 2025 data reportedly showed additive weight loss with semaglutide, favorable safety/tolerability, dose‑response insights, preclinical durability versus incretins, and manufacturing partnerships to enable higher‑dose subcutaneous delivery.