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BCS

Current Report · Items 7.01, 8.01, 9.01 · 8-K

Skye Bioscience, Inc.

Regulation FD Disclosure · Other Events

Item 7.01 Regulation FD Disclosure. On February 2, 2026, the Company issued a press release announcing interim results from the combination cohort of the Company's Phase 2a extension study of nimacimab.…

Filed Feb 2, 2026Accepted Feb 2, 2026, 7:04 AM ESTCIK 1516551Accession 0001628280-26-004451
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Company context

Current securities

Historical securities (9)

Recent company filings

  1. PRER14A filingOct 28, 2026
  2. PREM14A filingOct 26, 2026
  3. SCHEDULE 13G - filed by TANG CAPITAL MANAGEMENT LLC regarding Skye Bioscience, Inc.Oct 14, 2026
  4. DEFA14A filingSep 11, 2026
  5. Termination of a Material Definitive Agreement · Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Other EventsSep 11, 2026

Disclosure sections

Items 7.01, 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On February 2, 2026, the Company issued a press release announcing interim results from the combination cohort of the Company's Phase 2a extension study of nimacimab. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference and the Company's updated Investor Presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. The Investor Presentation will also be available under the “Media & Investors” page of the Company’s website. The information in Item 7.01 of this Current Report on Form 8-K, including the information in the press release and the Investor Presentation attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Current Report on Form 8-K, including the information in the press release and the Investor Presentation attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K, shall not be deemed to be incorporated by reference in the filings of the Company under the Exchange Act or the Securities Act of 1933, as amended.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events. On February 2, 2026, the Company reported the following interim results from the combination cohort of its Phase 2a extension study: • 19 participants in the combination cohorts completed week 26 and were eligible for the extension study, which continued in a blinded manner for 26 weeks, maintaining their original treatment assignment (10 nimacimab plus semaglutide; 9 placebo plus semaglutide). An additional 22 participants completed week 26 and were either ineligible for the extension or chose not to join the extension study and continued on post-treatment follow-up (11 nimacimab plus semaglutide; 11 placebo plus semaglutide). • Of the 10 participants in the nimacimab plus semaglutide arm who joined the extension study, the mean weight loss at 26 weeks was 14.4%. 7 participants completed the additional 26 weeks of treatment and lost an additional 7.9% of weight, resulting in a mean weight loss of 22.3% after 52 weeks of treatment. The combination therapy remained safe and well tolerated. No SAEs or AESIs were reported during the extension period. • Of the 9 participants in the placebo plus semaglutide arm that joined the extension study, mean weight loss at 26 weeks was -13.9%. 7 participants completed treatment of the additional 26 weeks and lost an additional -5.8% of weight during the extension period, resulting in a mean weight loss of -19.7% after 52 weeks of treatment. Full topline reporting of the CBeyond Phase 2a extension data including nimacimab monotherapy data and 13-week off-therapy follow-up is expected to take place in Q3 2026. The Company expects its current capital to fund projected operations and key clinical milestones into the fourth quarter of 2026, including topline data from the Phase 2a extension study of nimacimab and certain manufacturing and clinical activities, initial manufacturing runs needed to enable a subsequent trial, and planning activities, but excluding the anticipated clinical cost of a proposed Phase 2b study to evaluate higher doses of nimacimab and support combination development and additional anticipated drug manufacturing costs to resupply any such Phase 2b study. Additionally, the Company is evaluating potential further extensions of the Phase 2a study to evaluate higher doses of nimacimab.

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