(SKYE) Skye Bioscience, Inc. Business Model Canvas Research

Ophthalmology advisors and investigators help Skye Bioscience, Inc. shape study design and endpoint choice for glaucoma and ocular hypertension, where about 80 million people live with glaucoma worldwide. Their clinician-led input boosts trial credibility with regulators and partners, and can sharpen programs that need clean, eye-specific measures like IOP, a key endpoint in ocular studies.

• Guide endpoint selection and protocols
• Support glaucoma and ocular hypertension trials
• Raise trust with regulators and partners

Skye Bioscience, Inc. depends on capital markets and financing partners because it is still funding R&D, not product sales. Public equity investors, underwriters, and financing intermediaries help bridge cash needs until commercialization, when development-stage biotech firms often rely on repeated equity raises to keep trials moving.

• Equity markets fund R&D
• Intermediaries support capital raises
• Commercialization is the key shift

Skye Bioscience, Inc. must build a full regulatory file for each development step, including IND/CTA filings, investigator brochures, and safety reports, before moving into later-stage trials. For a clinical program with 1 lead asset, that means tight version control and rapid updates as new safety data come in.

• Stage-by-stage filings
• Investigator materials
• Safety reporting
• Needed before late trials

Skye Bioscience, Inc. uses intellectual property management to protect its cannabinoid-therapy pipeline, with patent coverage centered on SBI-100 and SBI-200. That IP base helps defend lead assets, extend market exclusivity, and strengthen future partnering and licensing talks as the company advances its programs.

• Protects SBI-100 and SBI-200
• Supports licensing talks
• Helps defend exclusivity

Skye Bioscience, Inc. relies on scientific and regulatory know-how to run early-stage programs like nimacimab with less trial risk. In biopharma, one missed FDA step can delay a study by months, so strong clinical planning, safety review, and regulator talks are core resources that protect the pipeline.

• Reduces clinical execution risk
• Supports safety and IND work
• Helps speed FDA interactions

As a U.S.-listed biopharma, Skye Bioscience, Inc. needs public-company infrastructure for SEC reporting, audit, legal, and treasury work. That means at least 4 core periodic filings each year, plus 8-K updates as needed, to keep funding access open and meet disclosure rules during long drug-development cycles that often run 10 years or more.

• Supports SEC reporting and audit controls
• Helps raise equity or debt capital
• Meets disclosure and governance duties
• Keeps funding alive for long R&D timelines

Skye Bioscience, Inc. targets a real gap in eye care: drugs must be well tolerated and reach the eye site without heavy side effects. A cannabinoid-based therapy could add a new eye mechanism for chronic disease, which matters when more than 80 million people live with glaucoma worldwide.

That value is strongest in long-term care, where even small gains in comfort and dosing can improve use and outcomes. If local delivery works, it can help turn a hard-to-treat eye disease into a more manageable one.

• Better tolerability can support long-term use
• Targeted eye delivery may reduce side effects
• New cannabinoid action could expand options
• Chronic diseases need durable, simple therapy

Skye Bioscience, Inc. has no commercial product yet, so the upside is in early data: if nimacimab or other assets show clear clinical benefit, the platform can gain licensing or co-development value fast. That matters because pre-revenue biotech deals in 2025 often still price optionality before sales.

• Early data can re-rate value sharply
• Licensing can monetize without launch
• No commercial sales means pure optionality

As a public Company, Skye Bioscience, Inc. keeps investors informed through earnings materials, press releases, and SEC filings. Clear, timely disclosure supports trust and helps preserve access to financing, which matters for a clinical-stage biotech that relies on capital markets.

In practice, this means updates on cash use, trial milestones, and risk factors must be easy to track. Transparent communication lowers information gaps and can reduce the cost of capital.

• SEC filings and earnings updates
• Press releases on trial progress
• Clear cash and financing updates

Scientific community outreach helps Skye Bioscience, Inc. turn SBI-100 and SBI-200 into credible, expert-reviewed programs. Conference talks and publications build trust with researchers, which can support future partnering and hiring; the company’s science focus is centered on 2 lead assets, so peer visibility matters.

• Builds expert awareness
• Validates SBI-100 and SBI-200
• Supports partnering and recruitment

Scientific and medical conferences help Skye Bioscience, Inc. build trust with ophthalmology specialists by showing preclinical and clinical progress in a peer-reviewed setting. These meetings also feed business development, since the 2025 ophthalmology conference calendar includes large forums that gather hundreds to thousands of retina and glaucoma decision-makers.

• Builds credibility with ophthalmologists
• Shares preclinical and clinical updates
• Supports partner and BD talks

Skye Bioscience, Inc. can use direct business development outreach to pitch licensing and co-development deals to pharma and biotech counterparties, helping turn pipeline assets into cash before launch. In 2025, the company reported cash, cash equivalents, and marketable securities of about $92.0 million, so this channel can support non-dilutive financing while it advances its clinical program.

• Targets pharma and biotech partners
• Supports licensing and partnership deals
• Helps monetize assets pre-launch

Ophthalmologists and clinical investigators are key gatekeepers for Skye Bioscience, Inc. because they drive trial site activation, patient enrollment, and the clinical data that later shape prescribing. WHO says 2.2 billion people have vision impairment, so specialist support matters for moving from study execution to real-world adoption.

• Drive enrollment and protocol quality
• Not payers, but key decision makers
• Support speeds adoption and prescribing

Pharma and biotech licensing partners are Skye Bioscience, Inc.'s commercial customer base in a pipeline-stage model: they can pay upfront fees, fund development, and share later sales rights. In 2025, this path is still common in biotech, where assets often move via milestone and royalty deals before full commercialization.

• Upfront cash de-risks R&D
• Milestones fund key trial steps
• Royalties tie pay to success

Skye Bioscience, Inc. must keep paying for FDA and other regulatory submissions, patent filings, and outside counsel, because its pipeline and IP are the core assets. For a public biotech, these legal and compliance costs also cover SEC reporting, board governance, and litigation risk, so they stay on the books even before product sales.

These spending lines protect exclusivity and keep the company able to advance candidates through development; if patent or filing work slips, value can drop fast.

• Regulatory filings are recurring costs
• Patent protection guards future value
• Public company compliance adds overhead

General and administrative costs at Skye Bioscience, Inc. cover its San Diego headquarters, payroll, finance, legal, and SEC reporting work. For a pre-commercial biopharma, this overhead stays material even before product sales, because the Company still must fund staff, compliance, and board-level support to keep operations running.

• San Diego HQ and core staff
• Payroll, finance, legal, reporting
• Overhead stays high pre-revenue

Future royalties on product sales could become a long-tail revenue stream for Skye Bioscience, but only if a partnered asset wins downstream approval and gets real market traction. In its latest filings, Skye Bioscience is still pre-commercial, so this path remains potential value, not current revenue.

• Needs partner-led approval
• Depends on sales uptake
• Usually arrives years later

Skye Bioscience, Inc. can use research grants and other non-dilutive funding to support discovery work and selected programs before product sales start. This matters in a pre-commercial biotech model because it can fund R&D without issuing new shares, so dilution stays lower for existing holders.

Non-dilutive capital is most useful when cash burn is high and revenue is still zero.

• Funds discovery and early studies
• Avoids shareholder dilution
• Best before commercial sales