Research and Development Expenses - For the three months ended September 30, 2024, the company incurred $4,883,337 in research and development expenses, a significant increase from $1,254,653 for the same period in 2023, primarily related to the Phase 2 clinical trial of nimacimab for obesity [77]. - Research and development expenses for the three months ended September 30, 2024, increased by $3,628,684 (289%) compared to the same period in 2023, totaling $4,883,337 [82]. - Research and development expenses for the nine months ended September 30, 2024, increased by $6,680,571 (158%) compared to the same period in 2023, totaling $10,908,538 [87]. - The increase in research and development expenses was primarily due to a $2,735,109 increase in contracted clinical and manufacturing costs for the Phase 2 clinical trial of nimacimab for obesity [82]. - The company anticipates ongoing research and development expenses will include costs for employee-related expenses, payments to third-party organizations, and manufacturing [78]. Clinical Trials - The Phase 2 clinical trial, CBeyond, for nimacimab includes 120 patients and aims to achieve 50% enrollment by the end of 2024, with interim data expected in Q2 2025 and topline data in Q4 2025 [73]. - The primary endpoint of the CBeyond trial is to evaluate weight loss using nimacimab compared to placebo, with secondary endpoints including safety, tolerability, and changes in metabolic biomarkers [73]. - The company completed a Phase 2a trial of SBI-100 Ophthalmic Emulsion in June 2024, which did not achieve statistically significant improvement, leading to the elimination of the ocular program [75]. Financial Performance - The company has not generated any revenue to date and does not expect to until regulatory approval and commercialization of nimacimab or future drug candidates [76]. - General and administrative expenses for the three months ended September 30, 2024, increased by $2,403,028 (107%) compared to the same period in 2023, totaling $4,638,927 [84]. - General and administrative expenses for the nine months ended September 30, 2024, increased by $7,813,970 (146%) compared to the same period in 2023, totaling $13,171,547 [90]. - Operating losses for the nine months ended September 30, 2024, were $19,526,617, compared to $30,648,916 for the same period in 2023 [94]. - Cash used in operating activities was $17,064,377 for the nine months ended September 30, 2024, reflecting a net loss of $16,820,644 [97]. Funding and Capital - The company raised a total of $83,556,563 from private placement equity transactions in January and March 2024, which will fund the clinical trial for obesity and expand the metabolic program [75]. - A Convertible Note with a principal value of $5,000,000 was converted into 968,973 shares of common stock in August 2024 [75]. - The company raised $83,556,563 in net proceeds from January and March PIPE Financings to fund its Phase 2 clinical trial for obesity [94]. - The company has not sold any shares under the ATM Agreement as of the date of the report, which allows for the sale of up to $100,000,000 of common stock [94]. Legal and Regulatory Matters - The Ninth Circuit Court of Appeals vacated the judgment in the Cunning Lawsuit, allowing the company to potentially extend its cash runway by the end of 2024 [75]. - The company expects to recover $9,080,202 in cash by exonerating the bond related to the Cunning Lawsuit, which will extend its cash runway [95]. - The change in estimate for legal contingencies for the three months ended September 30, 2024, was $(4,553,468), representing a 100% change [85]. - The change in estimate for legal contingencies for the nine months ended September 30, 2024, was $(4,553,468), a 2899% increase compared to $(151,842) in 2023 [92]. Other Financial Metrics - Interest income for the three months ended September 30, 2024, increased by $891,135 (5381%) compared to the same period in 2023 [86]. - Total other (income) expense for the three months ended September 30, 2024, was $(1,070,499), a decrease of $1,310,567 (546%) compared to the same period in 2023 [86]. - For the nine months ended September 30, 2024, the company reported a net other income of $2,716,044, primarily due to a gain on the sale of the AVI building and collections from the sale of VDL totaling $1,217,978 [93]. - Total other (income) expense for the nine months ended September 30, 2024, was $(2,716,044), a significant change from $2,572,338 in 2023, reflecting a 206% change [93]. - The company had working capital of $74,184,006 and an accumulated deficit of $121,203,193 as of September 30, 2024, with unrestricted cash and cash equivalents amounting to $67,412,614 [94].

Financial Performance - Skye Bioscience reported a net loss of $3.9 million for Q3 2024, a significant decrease from a net loss of $24.9 million in Q3 2023[9]. - General and administrative expenses rose to $4.6 million in Q3 2024, up from $2.2 million in Q3 2023, mainly due to non-cash stock-based compensation and professional services[9]. - The accumulated deficit increased to $(121,203,193) from $(104,382,549), indicating a rise in losses of about 16%[14]. Research and Development - Research and development expenses increased to $4.9 million in Q3 2024, compared to $1.3 million in the same period last year, primarily due to costs associated with the Phase 2 clinical trial for nimacimab[9]. - The Phase 2 obesity trial for nimacimab began patient enrollment in August 2024, targeting an 8% difference in mean weight loss compared to placebo at 26 weeks[3]. - Interim data from the Phase 2 trial is expected in Q2 2025, with topline data anticipated in Q4 2025 after full enrollment of 120 patients[3]. - New preclinical data showed dose-dependent weight loss of up to 16% in a diet-induced obesity model using nimacimab[4]. Cash and Assets - Cash and cash equivalents totaled $76.5 million as of September 30, 2024, with $9.1 million classified as restricted cash[8]. - Total current assets increased significantly to $79,808,229 as of September 30, 2024, compared to $11,650,843 on December 31, 2023, representing a growth of approximately 584%[14]. - Cash and cash equivalents rose to $67,412,614 from $1,256,453, marking an increase of over 5300%[14]. - Total assets reached $81,535,660, a substantial increase from $11,940,411, representing a growth of approximately 583%[14]. Liabilities and Equity - Total liabilities decreased to $5,732,285 from $14,072,229, a reduction of approximately 59%[14]. - Current liabilities decreased to $5,624,223 from $13,900,999, a decline of about 60%[14]. - Stockholders' equity improved to $75,803,375 from a deficit of $(2,131,818), indicating a turnaround of over $77 million[14]. - Additional paid-in capital rose to $196,976,230 from $102,238,382, reflecting an increase of approximately 93%[14]. Leadership and Legal Matters - Skye appointed Dr. Puneet Arora as Chief Medical Officer, enhancing its leadership in metabolic health[6]. - The U.S. Court of Appeals vacated a judgment related to litigation, allowing the company to recover $9 million in cash previously restricted[7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regis ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regi ...

As filed with the Securities and Exchange Commission on April 4, 2024 Registration No. 333-278286 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Under THE SECURITIES ACT OF 1933 SKYE BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 2834 45-0692882 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Indicate by check mark whether the registrant is a large accelerat ...

Table of Contents As filed with the Securities and Exchange Commission on March 27, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Primary Standard Industrial Nevada 2834 45-0692882 Classification Code Number) (I.R.S. Employer Identification Number) 11250 El Camino Real, Suite 100 San Diego, CA 92130 FORM S-1 REGISTRATION STATEMENT Under THE SECURITIES ACT OF 1933 SKYE BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) (State or other ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 000-55136 Skye Bioscience, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |---------- ...

Financial Performance - As of September 30, 2023, Skye Bioscience had a working capital of $1,567,627 and an accumulated deficit of $99,962,619[117]. - For the nine months ended September 30, 2023, the company incurred losses from operations of $30,648,916, compared to $9,028,662 for the same period in 2022, representing a 239% increase in losses[117]. - The net loss for the three months ended September 30, 2023, was $24,945,834, compared to $3,127,283 for the same period in 2022, indicating a significant increase in losses[117]. - The company incurred net losses of $33,224,854 for the nine months ended September 30, 2023, compared to $9,589,960 for the same period in 2022[135]. - The company expects to continue incurring significant losses and negative cash flows as it advances drug candidates in development and supports its corporate infrastructure[135]. - The net loss for the nine months ended September 30, 2023, was $33,224,854, partially offset by non-cash charges totaling $23,476,130[140]. Research and Development - Research and development expenses for the three months ended September 30, 2023, decreased by $527,071 (30%) to $1,254,653 compared to $1,781,724 in 2022[124]. - Research and development expenses for the nine months ended September 30, 2023 decreased by $246,564 (6%) to $4,227,967 compared to the same period in 2022, mainly due to reduced clinical contract costs and consulting expenses[129]. - The Phase 1 clinical study of SBI-100 Ophthalmic Emulsion (OE) was completed in June 2023, with a reported 23% mean reduction in intraocular pressure in a subset of participants[112]. - Skye plans to initiate a Phase 2 study of nimacimab for cardiometabolic disease, including obesity, in the first half of 2024[112]. - The Phase 2 study of SBI-100 OE will include 54 patients with primary open-angle glaucoma or ocular hypertension, with interim analysis expected in the first half of 2024[112]. - Skye's clinical pipeline includes nimacimab, a first-in-class molecule targeting the CB1 receptor, which is expected to add significant value to the company's offerings[115]. Expenses and Costs - General and administrative expenses for Q3 2023 increased by $1,095,341 (96%) to $2,235,899 compared to Q3 2022, driven by higher board fees, professional fees, and travel costs due to the BRB Acquisition and PIPE Financing[126]. - General and administrative expenses for the nine months ended September 30, 2023 rose by $803,446 (18%) to $5,357,577, influenced by increases in board and professional fees due to various financing activities[131]. - Total other expense for Q3 2023 was $240,068, an increase of $35,067 (17%) from $205,001 in Q3 2022, primarily due to increased interest expenses related to the Cunning Lawsuit[127]. - Total other expense for the nine months ended September 30, 2023 was $2,572,338, a significant increase of $2,016,181 (363%) from $556,157 in the same period of 2022, primarily due to debt conversion inducement expenses[134]. - Estimated legal contingency for the nine months ended September 30, 2023 was $(151,842), reflecting a reduction in legal fees related to the Cunning Lawsuit[133]. Financing and Cash Flow - The company raised $11,734,947 through PIPE Financing, issuing 2,989,981 shares of common stock and 2,325,537 warrants with an exercise price of $5.16[138]. - Cash provided by financing activities included $4,973,684 from a Convertible Note and $11,734,947 from PIPE Financing, net of issuance costs[145]. - The company reported a net cash used in operating activities of $10,107,460 for the nine months ended September 30, 2023, compared to $7,872,550 for the same period in 2022, reflecting an increase in operating losses[139]. - The company entered into a loan agreement for $250,000, which was later converted into an investment in PIPE Financing[138]. - The company has no outstanding warrants or debt as of September 30, 2023, following the exercise of all outstanding warrants by Sciences[138]. Operational Challenges - The company has implemented cost-cutting measures, including deferring employee payments and postponing non-essential studies, to extend its cash runway[136]. - The company faces substantial doubt regarding its ability to continue as a going concern due to recurring operating losses and the need for additional financing[138]. - The company expects to collect the remainder of the value from the divestiture of EHT's assets through 2026, but there are significant risks regarding the timing and realization of these assets[136].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regis ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regi ...