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Here are 1-3 brief analogies to describe Skye Bioscience (SKYE):

• GW Pharmaceuticals for eye diseases, but still in its early clinical trial stages.
• An early-stage biotechnology firm, akin to how a startup Amgen might have explored a novel drug class, but with a specific focus on cannabinoid-based therapies.

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• SBI-100 Ophthalmic Emulsion: An investigational drug designed to treat glaucoma and ocular hypertension by targeting the cannabinoid receptor type 1.
• SBI-093: A preclinical drug candidate being developed to address metabolic disorders, including obesity and other cardiometabolic conditions.

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Skye Bioscience (SKYE) is a clinical-stage biopharmaceutical company focused on developing drugs for inflammatory, fibrotic diseases, and glaucoma. As a company in the drug development phase, it does not currently have major customers in the traditional sense of selling a commercialized product directly to individuals or other companies.

Skye Bioscience's primary activities involve research, development, and conducting clinical trials for its drug candidates. At this stage, its "revenue" or funding primarily comes from:

• Equity financing from investors.
• Grants and collaborations.

Should its drug candidates successfully complete clinical trials and receive regulatory approval, Skye Bioscience would then seek to commercialize them. This commercialization would typically occur through one of the following paths:

1. Partnerships or Licensing Agreements with Larger Pharmaceutical Companies: In this scenario, larger pharmaceutical companies would become their "customers" by acquiring licensing rights to develop, manufacture, and/or market the approved drug. These potential future partners are currently unknown.
2. Building its Own Commercial Infrastructure: Less common for a company of this size in the early stages, but a possibility for direct sales if they choose to bring a product to market themselves. In this case, their customers would be healthcare providers (hospitals, pharmacies) and ultimately patients, but not directly from Skye Bioscience until a product is approved and launched.

Therefore, as of now, Skye Bioscience does not have a customer base that falls into the categories of direct sales to other companies or individuals for a commercialized product.

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Punit Dhillon, Director, President and Chief Executive Officer

Mr. Dhillon has served as Chairman and CEO of Skye Bioscience since 2020 and brings over 20 years of experience as an executive and investor in the life sciences industry. He has focused on early-stage biotechs, raising more than $500 million in capital and establishing numerous pharmaceutical partnerships. Mr. Dhillon was a co-founder and former CEO of OncoSec Medical, a biotechnology company focused on cancer immunotherapies, where he oversaw a partnership with Merck that helped raise over $200 million and uplisted the company to NASDAQ. Prior to Skye, he was a managing director of a private San Diego-based pharmaceutical company, where he launched an Asia-focused licensing business unit and completed a partnership with BMS. As Vice President, Finance and Operations at Inovio Pharmaceuticals, he completed licensing deals with Merck, Wyeth (now Pfizer), and Roche. He was previously a director of the Emerald group of companies, responsible for private equity investments, and started his career working for a venture fund. Skye Bioscience itself is backed by major life science investors like 5AM and Versant.

Kaitlyn Arsenault, Chief Financial Officer and Principal Accounting Officer

Ms. Arsenault was appointed CFO in October 2021 and possesses over 14 years of experience in accounting, auditing, financial reporting, mergers and acquisitions, and business operations within the life science and technology sectors. Before her appointment as CFO, she worked as an independent consultant for various emerging public and private companies, including Skye Bioscience for six years, providing expertise in SEC reporting, technical accounting, and stock-based compensation. She also served as an Assurance Manager in Friedman LLP's SEC practice, gaining extensive audit engagement experience across multiple industries.

Tu Diep, Chief Operating Officer

Mr. Diep was promoted to Chief Operating Officer in March 2025, having previously served as Chief Development Officer. He brings over 15 years of scientific and clinical research experience to Skye Bioscience. Mr. Diep was a founding employee of OncoSec Medical Inc. in 2011, where he led the development and initiation of their lead program and spearheaded a clinical collaboration with Merck. Before OncoSec, he held several positions at Protox Therapeutics Inc. (now Sophiris Bio Inc.), gaining extensive experience in preclinical R&D, clinical protocol development, and operations. While at Protox, he was involved in securing a $35 million investment from the private equity firm Warburg Pincus and solidifying a $75 million regional partnership with a Japanese pharmaceutical company.

Dr. Puneet S. Arora, Chief Medical Officer

Dr. Arora was appointed Chief Medical Officer in September 2024. He is a board-certified physician in endocrinology, diabetes, and metabolism, with over 15 years of experience in clinical trial design and execution, regulatory submissions, and medical affairs. His career includes serving as a physician-scientist, drug developer, and executive leader. Prior to joining Skye, Dr. Arora served as the Chief Medical Officer at Lassen Therapeutics, a clinical-stage development company focused on immunology and inflammation.

Chris Twitty, PhD, Chief Scientific Officer

Dr. Twitty serves as the Chief Scientific Officer of Skye Bioscience.

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The key risks for Skye Bioscience (symbol: SKYE) are primarily centered around the successful development and commercialization of its lead drug candidate, nimacimab, and the associated financial and legal implications.

• Clinical Trial Failure and Drug Efficacy: The most significant risk for Skye Bioscience is the potential failure of its lead drug candidate, nimacimab, in clinical trials. The company's success is heavily dependent on nimacimab demonstrating significant efficacy and safety in human trials, particularly for the treatment of obesity and metabolic disorders. Recent top-line data from its 26-week Phase 2a CBeyond™ study indicated that the nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo, with preliminary pharmacokinetic analysis suggesting lower than expected drug exposure, potentially requiring higher dosing. A failure to meet clinical endpoints could severely impact the company's prospects, investor confidence, and ability to secure future funding or partnerships.
• Financial Viability and Limited Operating History: Skye Bioscience has a limited operating history and is not yet profitable, relying on its cash reserves to fund operations and clinical development. The company is quickly burning through cash, and its ability to continue as a going concern depends on its capacity to obtain additional financing, which may not be available on favorable terms or at all. Unexpected expenses, delays in clinical trials, or increased costs could deplete capital resources faster than anticipated, impacting their cash runway.
• Securities Class Action Lawsuit: Skye Bioscience is currently facing a class action lawsuit alleging violations of the Securities Exchange Act of 1934. The lawsuit claims that the company made false and misleading statements regarding the efficacy of its nimacimab drug and its potential for regulatory approval and commercial success, particularly for investors who purchased shares between November 4, 2024, and October 3, 2025. This litigation poses a financial risk due to potential damages and legal fees, as well as a reputational risk that could further impact investor confidence.

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The overwhelming success and market dominance of GLP-1 receptor agonists (such as Wegovy, Ozempic, Zepbound) for obesity and metabolic diseases represent a significant emerging threat to Skye Bioscience's SBI-093 program. These highly effective drugs are rapidly establishing a new standard of care in the weight loss and metabolic health markets, creating an extremely challenging competitive landscape for any new entrant, including SBI-093, which is in early-stage development for similar indications.

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Skye Bioscience (SKYE) is currently focusing its product development on nimacimab, a peripherally restricted negative allosteric modulating antibody targeting cannabinoid receptor 1 (CB1) for the treatment of obesity and other metabolic diseases. The company has discontinued clinical development of SBI-100 Ophthalmic Emulsion for glaucoma.

The addressable market sizes for Skye Bioscience's main product candidate, nimacimab, which targets obesity and metabolic disorders, are substantial:

• The global market size for metabolic disorders drugs was valued at approximately $65 billion in 2023 and is projected to reach around $110 billion by 2032.
• The global metabolic disorder therapeutics market generated revenue of $77.24 billion in 2024 and is expected to reach $120.71 billion by 2030.
• Another estimate places the global Metabolic Disorder Therapeutics Market size at $77.59 billion in 2024, with projections to reach $140.29 billion by 2032.
• The metabolic disorders therapeutics market was valued at $62.14 billion in 2023 and is expected to grow to $67.79 billion in 2024, with a projected increase to $136.07 billion by 2032.

North America is a significant region within this market, holding the largest share for metabolic disorder therapeutics in 2024, with the U.S. projected to lead the global market by 2030. Diabetes alone represented a dominant segment of the metabolic disorders therapeutics market, accounting for approximately 30% of the market share in 2024.

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Expected Drivers of Future Revenue Growth for Skye Bioscience (SKYE)

Over the next 2-3 years, the anticipated drivers of future revenue growth for Skye Bioscience are primarily centered around the successful advancement and potential commercialization of its lead drug candidate, nimacimab (also referred to as Nemesimab), for obesity and metabolic disorders.

1. Successful Progression of Nimacimab through Clinical Trials for Obesity (Monotherapy and Combination Therapy): Skye Bioscience's primary driver of future revenue growth hinges on the continued positive development and successful completion of clinical trials for nimacimab in obesity. The company has reported promising results from its Phase 2a study, particularly when nimacimab was dosed in combination with semaglutide, demonstrating a 29% relative increase in weight loss and reduced weight regain compared to semaglutide alone. Plans are in place to initiate a Phase 2B combination study, and the company expects to present further data in 2026. These advancements are crucial steps toward potential market approval and subsequent revenue generation.
2. Development of Nimacimab for a Weight Loss Maintenance Indication: A key strategic focus and a significant potential revenue driver is the development of nimacimab as a maintenance therapy to prevent weight regain after initial weight loss, particularly following treatment with incretin-based therapies like GLP-1s. Preclinical data suggest nimacimab can substantially reduce rebound weight gain, offering a distinct and valuable solution in the competitive obesity treatment landscape. The company is aggressively pursuing this maintenance indication, which could address a critical unmet need.
3. Differentiation and Market Positioning of Nimacimab: Nimacimab's unique mechanism as a first-in-class, peripherally-restricted CB1 inhibitor antibody positions it with potential differentiation in the obesity market. The drug has shown a favorable safety profile with no neuropsychiatric side effects observed in combination therapy, and no increased gastrointestinal side effects, which could provide a competitive advantage over existing therapies that sometimes face tolerability challenges. This strong differentiation could help nimacimab capture a significant market share upon commercialization.

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Share Issuance

• Skye Bioscience's shares outstanding increased by 82.20% in one year.

Inbound Investments

• Skye Bioscience has raised $107 million in capital since mid-2023 from specialist life science investors, including 5AM Ventures.

Capital Expenditures

• Capital expenditures for Skye Bioscience in the last 12 months amounted to approximately -$1.57 million.