Skye Bioscience, Inc. 10-Q

Item 1. Financial Statements 2 SKYE BIOSCIENCE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS March 31, 2025 December 31, 2024 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 46,421,299 $ 68,415,741 Short-term investments 12,802,650 — Prepaid expenses 575,382 201,962 Other current assets 3,228,450 2,209,544 Total current assets 63,027,781 70,827,247 Property and equipment, net 1,304,148 1,432,752 Operating lease right-of-use asset 407,401 449,864 Other assets 53,910 53,910 Total assets $ 64,793,240 $ 72,763,773 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 1,713,832 $ 569,252 Accrued payroll liabilities 656,131 1,114,255 Other current liabilities 847,849 654,201 Estimate for accrued legal contingencies and related expenses 1,913,003 1,818,751 Operating lease liability, current portion 188,645 182,428 Total current liabilities 5,319,460 4,338,887 Non-current liabilities Operating lease liability, net of current portion 223,466 273,162 Total liabilities 5,542,926 4,612,049 Commitments and contingencies (Note 7) Stockholders’ equity Preferred stock, $ 0.001 par value; 200,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued and outstanding at March 31, 2025 and December 31, 2024 — — Common stock, $ 0.001 par value; 100,000,000 shares authorized at March 31, 2025 and December 31, 2024; 30,974,559 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 30,975 30,975 Additional paid-in-capital 201,272,330 199,070,421 Accumulated deficit ( 142,052,991 ) ( 130,949,672 ) Total stockholders’ equity 59,250,314 68,151,724 Total liabilities and stockholders’ equity $ 64,793,240 $ 72,763,773 See accompanying notes to the unaudited condensed consolidated financial statements. 3 SKYE BIOSCIENCE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) For the three months ended March 31, 2025 2024 Operating expenses Research and development $ 7,197,257 $ 1,946,450 General and administrative 4,562,305 4,205,800 Total operating expenses 11,759,562 6,152,250 Operating loss ( 11,759,562 ) ( 6,152,250 ) Other (income) expense Interest expense 1,452 436,936 Interest income ( 619,054 ) ( 427,554 ) Gain on sale of asset — ( 1,145,141 ) Other (income) expense ( 40,641 ) 1,040 Total other (income) expense, net ( 658,243 ) ( 1,134,719 ) Loss before income taxes ( 11,101,319 ) ( 5,017,531 ) Provision for income taxes 2,000 2,000 Net loss $ ( 11,103,319 ) $ ( 5,019,531 ) Loss per common share: Basic $ ( 0.28 ) $ ( 0.18 ) Diluted $ ( 0.28 ) $ ( 0.18 ) Weighted average shares of common stock outstanding used to compute loss per share: Basic 39,651,888 27,999,901 Diluted 39,651,888 27,999,901 See accompanying notes to the unaudited condensed consolidated financial statements. 4 SKYE BIOSCIENCE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) For the Three Months Ended March 31, 2025 2024 Cash flows from operating activities: Net Loss $ ( 11,103,319 ) $ ( 5,019,531 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 177,379 27,560 Stock-based compensation expense 2,201,909 2,478,179 Amortization of debt discount — 237,205 Gain on sale of asset — ( 1,145,141 ) Changes in assets and liabilities: Prepaid expenses ( 373,420 ) ( 446,277 ) Other current assets ( 1,018,906 ) ( 386,513 ) Accounts payable 1,215,779 ( 60,652 ) Accrued interest - legal contingency — 75,073 Accrued payroll liabilities ( 458,124 ) ( 534,919 ) Operating lease liability ( 43,479 ) ( 16,780 ) Other current liabilities 216,701 83,673 Net cash used in operating activities ( 9,185,480 ) ( 4,708,123 ) Cash flows from investing activities: Proceeds from the sale of assets, net of sales costs — 1,145,141 Purchase of short-term investments ( 12,802,650 ) — Purchase of property and equipment ( 6,312 ) ( 3,181 ) Net cash (used in) provided by investing activities ( 12,808,962 ) 1,141,960 Cash flows from financing activities: Proceeds from the issuance of common stock and warrants, net of equity issuance costs of $ 0 and $ 4,338,393 , respectively — 85,652,617 Net cash provided by financing activities — 85,652,617 Net (decrease) increase in cash, cash equivalents and restricted cash ( 21,994,442 ) 82,086,454 Cash, cash equivalents and restricted cash, beginning of period $ 68,415,741 $ 10,336,655 Cash, cash equivalents and restricted cash, end of period $ 46,421,299 $ 92,423,109 Supplemental disclosures of cash-flow information: Reconciliation of cash, cash equivalents and restricted cash: Cash and cash equivalent $ 46,421,299 $ 83,342,907 Restricted cash — 9,080,202 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 46,421,299 $ 92,423,109 Supplemental disclosures of non-cash financing activities: Accrued financing charges $ — $ 2,096,054 See accompanying notes to the unaudited condensed consolidated financial statements. 5 SKYE BIOSCIENCE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED) Common Stock Additional Paid-In Capital Accumulated Deficit Total Stockholders’ Equity Shares Amounts Balance, January 1, 2025 30,974,559 $ 30,975 $ 199,070,421 $ ( 130,949,672 ) $ 68,151,724 Stock-based compensation expense — — 2,201,909 — 2,201,909 Net loss for the three months ended March 31, 2025 — — — ( 11,103,319 ) ( 11,103,319 ) Balance, March 31, 2025 30,974,559 $ 30,975 $ 201,272,330 $ ( 142,052,991 ) $ 59,250,314 Common Stock Additional Paid-In Capital Accumulated Deficit Total Stockholders’ Equity/(Deficit) Shares Amounts Balance, January 1, 2024 12,349,243 $ 12,349 $ 102,238,382 $ ( 104,382,549 ) $ ( 2,131,818 ) Stock-based compensation expense — — 2,478,179 — 2,478,179 Issuance of common stock and warrants, net of issuance costs of $ 6,434,447 15,713,664 15,714 83,540,849 — 83,556,563 Net loss for the three months ended March 31, 2024 — — — ( 5,019,531 ) ( 5,019,531 ) Balance, March 31, 2024 28,062,907 $ 28,063 $ 188,257,410 $ ( 109,402,080 ) $ 78,883,393 See accompanying notes to the unaudited condensed consolidated financial statements. 6 SKYE BIOSCIENCE, INC. AND SUBSIDIARIES NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. Organization, Basis of Presentation and Significant Accounting Policies Nature of Operations Skye Bioscience, Inc. (the “Company” or “Skye”) was incorporated in Nevada on March 16, 2011. The Company is a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors ("GPCRs") to treat obesity, overweight, and related conditions. As of March 31, 2025, the Company has devoted substantially all its efforts to securing its product pipeline, carrying out research and development, preparing for and conducting clinical trials, building infrastructure and raising capital. The Company has not yet realized revenue from its planned principal operations and is a number of years away from potentially being able to do so. Impact of Geopolitical and Macroeconomic Factors It is possible that the Company may encounter supply chain issues related to global economic and political conditions such as a lack of production or laboratory resources, pandemics or cyberattacks that could cause business disruptions and clinical trial delays which will need to be managed in the future. There may also be significant uncertainty resulting from the impact of other geopolitical and macroeconomic factors, including global pandemics, tariffs, inflation, supply chain issues, fluctuating interest rates, future bank failures and increased geopolitical tensions between the U.S. and its international trade partners, including China. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. Interim financial results are not necessarily indicative of results anticipated for the full year, or any future periods. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and the accompanying notes. Actual results could differ from those estimates The unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, from which the prior year balance sheet information herein was derived. During the three months ended March 31, 2025 , there were no changes to the Company's significant accounting policies as described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 . Pronouncements Implemented In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-09, Improvements to Income Tax Disclosures. This ASU requires greater disaggregation of information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. This ASU applies to all entities subject to income taxes and is intended to help investors better understand an entity’s exposure to potential changes in jurisdictional tax legislation and assess income tax information that affects cash flow forecasts and capital allocation decisions. This ASU is effective for annual periods beginning after December 15, 2024, with early adoption permitted. This ASU should be applied on a prospective basis although retrospective application is permitted. The Company adopted this ASU as of January 1, 2025. The Company's adoption of this ASU did not have a significant impact on the Company's condensed consolidated financial statements. 7 Recent Accounting Pronouncements Not Yet Adopted In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires additional disclosure of the nature of expenses included in the income statement. The standard requires disclosures about specific types of expenses included in the expense captions presented in the income statement as well as disclosures about selling expenses. This ASU is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The requirements should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures. 2. Fair Value Measurement The Company’s financial instruments measured at fair value on a recurring basis consist of Level 1 financial instruments. The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): Fair Value Measurement as of March 31, 2025 Total Level 1 Assets: Money Market Funds (included in cash and cash equivalents) $ 31,963,993 $ 31,963,993 U.S. Treasury Obligations (included in cash and cash equivalents) 11,940,160 11,940,160 Total fair value of assets in cash and cash equivalents $ 43,904,153 $ 43,904,153 U.S. Treasury Obligations (included in short-term investments) 12,802,650 12,802,650 Total fair value of assets included in short-term investments $ 12,802,650 $ 12,802,650 The amount of unrealized gain (losses) was immaterial for the three months ended March 31, 2025. 8 3 . Prepaid Expenses, Other Current Assets and Liabilities Prepaid expenses consist of the following: March 31, 2025 December 31, 2024 Prepaid clinical expenses $ 4,085 $ 13,078 Total other prepaid expenses 571,297 188,884 $ 575,382 $ 201,962 Other current assets consist of the following: March 31, 2025 December 31, 2024 AusIndustry incentive $ 8,228 $ 8,151 Vendor deposits 3,061,695 1,997,274 Other tax receivables 6,387 5,065 Other current assets 152,140 199,054 $ 3,228,450 $ 2,209,544 Other current liabilities consist of the following: March 31, 2025 December 31, 2024 Research and development costs $ 542,056 $ 325,415 Legal expenses 141,050 114,359 Consulting and professional fees 113,627 109,375 Other accrued liabilities 51,116 105,052 $ 847,849 $ 654,201 9 4. Warrants There are significant judgements and estimates inherent in the determination of the fair value of the Company’s warrants. These judgements and estimates include assumptions regarding the Company’s future operating performance and the determination of the appropriate valuation methods. Warrants vested and outstanding as of March 31, 2025, are summarized as follows: Source Exercise Price Weighted Average Remaining Contractual Term (Years) Number of Warrants Outstanding 2015 Common Stock Warrants $ 1,250.00 0.06 400 2016 Common Stock Warrants to Service Providers 287.50 1.58 160 2020 Common Stock Warrants to Placement Agent 20.00 0.33 32,668 2021 Inducement Warrants 37.50 1.32 84,667 2021 Inducement Warrants to Placement Agent 47.00 1.32 5,927 2021 Common Stock Warrants 22.50 1.49 311,113 2021 Common Stock Warrants to Placement Agent 27.50 1.49 21,778 August 2023 Convertible Note Common Stock Warrants 5.16 8.38 340,000 August 2023 PIPE Financing Common Stock Warrants 5.16 8.38 2,325,537 January 2024 Pre-Funded Warrants Common Stock 0.001 Indefinite 8,677,166 Total warrants outstanding as of March 31, 2025 11,799,416 As of March 31, 2025, all of the Company's warrants are fully vested . 5. Stock-Based Compensation Stock Incentive Plan On October 31, 2014, the Board of Directors of the Company (the "Board") approved the Company’s 2014 Omnibus Incentive Plan (the "2014 Omnibus Incentive Plan"). On June 14, 2022, the Board approved the 2014 Amended and Restated Omnibus Incentive Plan (the “2014 Amended and Restated Plan”) which replaced the 2014 Omnibus Incentive Plan in its entirety. On September 29, 2023, the Board and holders of a majority of the voting power of the outstanding capital stock of the Company adopted and approved Amendment No. 1 to the 2014 Amended and Restated Plan. Amendment No. 1 to the 2014 Amended and Restated Plan became effective on November 6, 2023. On October 22, 2024, the second amendment and restatement of the Company's 2014 Amended and Restated Plan was approved to increase the number of shares of the Company's common stock issuable to 4,000,000 , extend the expiration date of the plan to September 10, 2034, update the name of the plan to the “Skye Bioscience, Inc. Amended and Restated Omnibus Incentive Plan” and make certain administrative amendments (as so amended and restated, the "Amended and Restated Plan"). As of March 31, 2025, the Company had 1,170,197 shares available for future grant under the Amended and Restated Plan. 2024 Inducement Equity Incentive Plan On July 2, 2024, the Board adopted the Skye Bioscience, Inc. 2024 Inducement Equity Incentive Plan (the "Inducement Plan"). The Company has reserved 600,000 shares of the Company’s common stock for issuance pursuant to awards granted under the Inducement Plan. As of March 31, 2025, the Company had 230,500 shares available for future grant under the Inducement Plan. 10 Stock Options The following is a summary of option activity under the Company’s Amended and Restated Plan and the Inducement Plan, for the three months ended March 31, 2025: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value* Outstanding, December 31, 2024 3,036,603 $ 7.72 8.91 $ 22,624 Granted 1,216,000 2.89 Cancelled ( 4,091 ) 19.72 Forfeited ( 13,000 ) 7.56 Outstanding, March 31, 2025 4,235,512 $ 6.32 9.03 $ — Exercisable, March 31, 2025 979,924 $ 9.42 7.26 $ — *The aggregate intrinsic value is the sum of the amounts by which the quoted market price of the Company’s stock exceeded the exercise price of the stock options at March 31, 2025 for those stock options for which the quoted market price was in excess of the exercise price ("in-the-money options"). The weighted-average grant-date fair value of stock options granted during the three months ended March 31, 2025, was $ 2.11 . The fair value of each stock option grant was estimated on the date of grant using the Black-Scholes option-pricing model under the following assumptions: Three Months Ended March 31, 2025 Dividend yield 0.00 % Volatility factor 83.87 - 85.93 % Risk-free interest rate 4.24 - 4.27 % Expected term (years) 5.27 - 6.08 Restricted Stock Units The following is a summary of restricted stock unit activity during the year ended March 31, 2025: Number of Shares Weighted Average Exercise Price Unvested, December 31, 2024 503,113 $ 9.62 Granted — — Unvested, March 31, 2025 503,113 $ 9.62 Stock-Based Compensation Expense The Company recognizes stock-based compensation expense using the straight-line method over the requisite service period or derived service period. The Company recognized stock-based compensation expense for the stock options and the restricted stock units ("RSUs") discussed above, in its Unaudited Condensed Consolidated Statements of Operations as follows: 11 Three Months Ended March 31, 2025 2024 Research and development $ 489,588 $ 391,611 General and administrative 1,712,321 2,086,568 $ 2,201,909 $ 2,478,179 The total amount of unrecognized compensation cost was $ 15,034,895 as of March 31, 2025. This amount will be recognized over a weighted average period of 2.75 years. 2022 Employee Stock Purchase Plan In June 2022, the Board approved the 2022 Employee Stock Purchase Plan (the "ESPP"), under which the Company may offer eligible employees the option to purchase common stock at a 15 % discount to the lower of the market value of the stock at the beginning or end of each participation period under the terms of the ESPP. Total individual purchases in any year are limited to 15 % of compensation. The ESPP was approved by the Company's stockholders on September 30, 2022. As of March 31, 2025, no shares were issued under the ESPP. The compensation expense, computed using the Black-Scholes model was immaterial. 6. Loss Per Share of Common Stock The following tables are a reconciliation of the numerators and denominators used in the calculation of basic and diluted net loss per share computations: Three Months Ended March 31, 2025 2024 Basic EPS and diluted EPS: Loss (Numerator) Net loss $ ( 11,103,319 ) $ ( 5,019,531 ) Shares (Denominator) Weighted average common shares outstanding 39,651,888 27,999,901 Per-Share Amount $ ( 0.28 ) $ ( 0.18 ) The following outstanding shares of common stock equivalents were excluded from the computation of diluted net loss per share of common stock for the periods presented because including them would have been anti-dilutive: Three Months Ended March 31, 2025 2024 Stock options 4,235,512 1,201,398 Warrants 3,122,250 3,280,940 Unvested restricted stock units 503,113 503,444 Unvested restricted stock — 5,000 Convertible debt — 968,922 7. Contingencies General Litigation and Disputes From time to time, in the normal course of operations, the Company may be a party to litigation and other dispute matters and claims. Litigation can be expensive and disruptive to normal business operations. Moreover, the results of complex legal proceedings are difficult to predict. An unfavorable outcome to any legal matter, if material, could have a materially adverse effect on the Company’s operations or financial position, liquidity or results of operations. 12 Wendy Cunning vs Skye Bioscience, Inc. The Company is a party to a legal proceeding with a former employee alleging, among other things, wrongful termination, violation of whistleblower protections under the Sarbanes-Oxley Act of 2002, and retaliation under California law against the Company relating to certain actions and events that occurred with the Company's former management during the employee's employment term from March 2018 to July 2019. The case, entitled Wendy Cunning vs Skye Bioscience, Inc. , was filed in U.S. District Court (the "District Court") for the Central District of California (the “Cunning Lawsuit”). On January 18, 2023, a jury rendered a verdict in favor of Ms. Cunning and awarded her $ 512,500 in economic damages (e.g., lost earnings, future earnings and interest), $ 840,960 in non-economic damages (e.g., emotional distress) and $ 3,500,000 in punitive damages. On August 2, 2023, the District Court ruled on the plaintiff's motion for attorney fees and awarded the plaintiff $ 1,200,008 . Based on this order, the Company reduced the aggregate estimate for the legal contingency by $ 151,842 , the difference between the attorney fees awarded by the District Court and the Company's previous estimate. On August 17, 2023, the Company obtained a stay on enforcement of the judgment in the Cunning Lawsuit by posting an appeal bond in the amount of $ 9,080,202 . In March of 2023, the Company appealed the judgment in the Cunning Lawsuit to the United States Court of Appeals for the Ninth District (the "Ninth Circuit"). On October 22, 2024, the Ninth Circuit issued its decision in the Company's favor which vacated the judgment and remanded the case back to the District Court for a new trial. As a result, the Company recovered the $ 9,080,202 restriction on its cash related to the bond during the year ended December 31, 2024. The new trial is currently scheduled to be held in September 2025. During the year ended December 31, 2024, management revised its assumptions related to its estimate of the legal contingency and the the Company reversed the accrued interest on the original judgment and recognized a gain of $ 4,234,717 in change in estimate for legal contingencies. As of March 31, 2025, the estimated legal contingency, including accrued legal expenses, is $ 1,913,003 . In arriving at the conclusion that a significant portion of the estimated legal contingency should be reversed, the Company considered the following in revising its assumptions: • advice from external advisors including its technical accounting advisors regarding the appropriate application of GAAP and legal counsel’s advice with regard to prior experience with similar cases, • the damages and potential attorney fee awards if the case were to be retried, including the likelihood of a subsequent loss if the Company were to be unsuccessful, while giving consideration to the facts and circumstances that would be inadmissible due to the Ninth Circuit’s decision, • the likelihood of settlement and information obtained during settlement discussions prior to the first trial, • the Company’s possible defenses and counterclaims, and • the case history and the amount of the prior judgment. The final amount of the loss and loss recoveries remain uncertain. The ultimate amount of the potential loss may be significantly less than the amount of the revised legal contingency and there is no guarantee that the Company will be successful in its efforts to recover additional losses. The Company believes that it is at least reasonably possible that the estimated amount of the potential loss may change in the near term. 8 . Segment Reporting The Company operates in one business segment, which includes the business of research and development activities related to developing medicine for obesity and other metabolic diseases. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”). The Company’s CODM is its Chief Executive Officer, who reviews and evaluates consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods. In addition to the significant expense categories included within consolidated net loss presented on the Company's Consolidated Statements of Operations, see below for disaggregated amounts that comprise research and development expenses which are presented to the Company's CODM for review: 13 Three Months Ended March 31, 2025 2024 External clinical development expenses (1) SBI-100 $ 5,408 $ 860,694 nimacimab 5,184,865 129,120 Personnel related and stock-based compensation 1,337,958 811,789 Other research and development expenses (2) 669,026 144,847 Total research and development expenses $ 7,197,257 $ 1,946,450 (1) External clinical development expenses include expenses for clinical trial costs and clinical manufacturing, as well as costs for discovery in research and development studies. (2) Other research and development expenses include expenses for travel and entertainment, consulting and advisory and general business expenses. The amount of property and equipment in the US was equal to $ 81,180 and $ 144,006 for March 31, 2025, and December 31, 2024 , respectively. The amount of property and equipment outside of the US was equal to $ 1,222,967 , and $ 1,522,258 for March 31, 2025, and December 31, 2024 , respectively. 9 . Subsequent Events Subsequent to March 31, 2025 , the Company granted an aggr egate of 119,000 optio ns to purchase common stock to its employees under the Inducement Plan. 14