Announcement • May 16
Skye Bioscience, Inc. Announces Notice of Non-Compliance with Nasdaq Global Market Listing Rule On May 13, 2026, Skye Bioscience, Inc. (the Company" or Skye") received a written notification from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that, based on the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, the Company's stockholders' equity was $9,011,804, and therefore, the Company was not in compliance with Nasdaq Global Market's Listing Rule 5450(b)(1)(A), which requires a $10,000,000 minimum stockholders' equity standard. The Notice has no immediate effect on the listing or trading of the Company's common stock, par value $0.001 per share (the common stock") on the Nasdaq Global Market and the common stock will continue to trade under the symbol SKYE". Pursuant to Nasdaq Marketplace Rule 5810(c)(2)(C), the Company has been provided 45 calendar days, or until June 29, 2026, to supply a specific plan to regain compliance with all Nasdaq Global Market listing requirements and the Company's time frame to complete its plan. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the Notice, or until November 9, 2026, to evidence compliance. If the plan is not accepted, the Company will have the right to appeal and the common stock would remain listed on The Nasdaq Global Market until the completion of the appeal process. To regain compliance, the Company must have stockholders' equity of at least $10,000,000. The Company is currently evaluating various alternative courses of action to regain compliance. There can be no assurance that the Company will be able to regain compliance with the minimum stockholders' equity requirement or maintain compliance with the other listing requirements. 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. 
