Announcement • Apr 17
Skye Bioscience, Inc., Annual General Meeting, May 26, 2026 Skye Bioscience, Inc., Annual General Meeting, May 26, 2026. Announcement • Apr 02
Skye Bioscience Treats First Patient in Nimacimab Higher-Dose Expansion Study Skye Bioscience, Inc. treated the first patient in its Part C expansion study of the CBeyond Phase 2a trial to characterize safety and pharmacokinetics (PK) at exposures designed to challenge the peripheral restriction of nimacimab through intravenous (IV) administration over 16 weeks of treatment. These doses will set the benchmark for the safety profile of nimacimab and support higher dosing in combination with incretin therapies. The expansion study comprises two cohorts of nimacimab monotherapy (400 mg IV and 600 mg IV) compared to placebo administered weekly over 15 weeks (16 doses), with a 12 week follow-up period, to generate preliminary safety and PK data with administration of higher doses. Based on the Company’s translational work, 400 mg IV and 600 mg IV correspond to approximately ~700 mg and 1,000 mg subcutaneous dosing, respectively, and are projected to achieve substantially higher peripheral tissue exposure than the 200 mg subcutaneous dose tested in the Phase 2a study. Within each dose cohort, 8 participants will be randomized in a 3:1 ratio to nimacimab (n=6) or placebo (n=2). Enrollment in Cohort 2 (600 mg IV) is contingent on a favorable safety review of the first participants completing four weeks of treatment in Cohort 1 (400 mg IV) by an independent Cohort Review Committee. Topline data from the expansion study is expected in the fourth quarter of 2026. Part C follows the completion of the Phase 2a CBeyond trial and its extension, which evaluated nimacimab at 200 mg subcutaneous weekly as both monotherapy and in combination with semaglutide (Wegovy 2.4 mg). Key findings from the completed study program include: 22.3% mean weight loss at 52 weeks in the combination arm with no plateau observed; statistically significant improvements in waist circumference and lean-to-fat mass ratio versus semaglutide alone at 26 weeks; over 50% reduction in weight regain during the 13-week off-treatment follow-up period in the combination cohort versus semaglutide alone; and no drug-related neuropsychiatric adverse events in any treatment arm through the full study period. Nimacimab monotherapy at 200 mg weekly produced modest weight loss, which the Company attributes to insufficient peripheral tissue exposure based on subsequent translational analysis. Part C is designed to resolve this exposure question at doses modeled to approach or achieve the peripheral target-engagement threshold. Nimacimab is a potential first-in-class, peripherally-restricted monoclonal antibody inhibitor of the CB1 receptor. Unlike previous CB1-targeting drugs, nimacimab is designed to avoid central nervous system penetration, potentially limiting neuropsychiatric side effects seen with small-molecule antagonists. As a non-incretin, non-peptide agent, nimacimab acts independently of the GLP-1 pathway and has demonstrated additive effects in combination with semaglutide in the Phase 2a CBeyond trial. The Company is developing nimacimab as a potential orthogonal add-on therapy for patients with obesity who are experienced on or have plateaued with GLP-1-based treatment, targeting clinically meaningful incremental weight loss, improved body composition, and reduced weight regain without added gastrointestinal or neuropsychiatric burden. Announcement • Mar 20
Skye Bioscience, Inc. Receives Deficiency Letter from Nasdaq Regarding Minimum Bid Price Requirement On March 17, 2026, Skye Bioscience, Inc. (the Company or Skye) received a deficiency letter from the Nasdaq Listing Qualifications Department (the Staff) of the Nasdaq Stock Market LLC (Nasdaq) notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company's common stock, par value $0.001 per share (the Common Stock) had been below the minimum $1.00 per share required for continued listing on The Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(a)(1) (Rule 5450(a)(1)). The Nasdaq deficiency letter has no immediate effect on the listing of the Company's Common Stock, and the Common Stock will continue to trade on The Nasdaq Global Market under the symbol SKYE at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until September 14, 2026, to regain compliance with Rule 5450(a)(1). If the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to September 14, 2026, to regain compliance. If at any time before September 14, 2026, the bid price of the Common Stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that the Company has regained compliance. If the Company does not regain compliance with Rule 5450(a)(1) by September 14, 2026, the Company may be afforded a second 180 calendar day period to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the minimum bid price requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the deficiency during the second compliance period. The Company intends to actively monitor the closing bid price for the Common Stock and will consider available options to resolve the deficiency and regain compliance with Rule 5450(a)(1). However, there can be no assurance that the Company will be able to regain compliance with the Rule 5450(a)(1) or will otherwise be in compliance with other Nasdaq Listing Rules. 
