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Skye Bioscience, Inc.

For the period ended Oct 6, 2025. Filed Oct 6, 2025.

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About this filing

A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.

Oct 6, 2025 · Filed Oct 6, 2025

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SKYE$0.99-4.8%Stored close · as of Nov 6, 2026
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EX-99.1 · FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to the preliminary pharmacokinetic analysis and dose-exposure response analysis and the potential for higher dosing of nimacimab to achieve greater drug exposure and increased efficacy; the potential for future weight loss beyond 26 weeks; plans to advance nimacimab into the next stage of development to optimize dosing; future clinical development of nimacimab, including the initiation and design of any future clinical trials; the expected timing for reporting data from the Phase 2a extension study; the ability of nimacimab to drive weight loss without neuropsychiatric adverse events; the potential for nimacimab to be a first-in-class drug. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by the Company’s capital resources, the Company’s ability to obtain additional sources of capital needed to run an additional Phase 2 clinical trial, program considerations and potentially other factors outside the Company’s control; the Company's preliminary pharmacokinetic and dose-exposure analysis is not complete, and such analysis may change following receipt of the full pharmacokinetic modeling and dose-exposure response analysis; the potential for additional weight loss after 26 weeks may not ultimately be observed; there is no guarantee that higher dosing of nimacimab will achieve increased efficacy, and likewise it is possible that higher dosing will produce adversely different safety and tolerability results than those observed to date; the Company’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab, competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; the Company’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; the Company’s ability to protect its intellectual property; risks associated with the Company’s common stock and the other important factors discussed under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

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