Financial Performance - Skye Bioscience reported a net loss of $9.7 million for Q4 2024, compared to a net loss of $4.4 million for the same period in 2023[20]. - The net loss for Q4 2024 was $9,746,479, compared to a net loss of $4,419,930 in Q4 2023, indicating an increase in losses of 120%[27]. - Basic loss per share for Q4 2024 was $(0.24), an improvement from $(0.36) in Q4 2023, reflecting a reduction in loss per share of 33%[27]. - Total operating expenses for the year ended December 31, 2024, were $30,192,718, down from $34,735,173 in 2023, representing a decrease of 13%[27]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $7.8 million, a significant increase from $1.6 million in Q4 2023, primarily due to clinical trial costs for nimacimab[15]. - Skye's R&D expenses for the full year 2024 were $18.7 million, compared to $5.8 million in 2023, reflecting increased clinical trial activities[16]. - Research and development expenses for Q4 2024 were $7,793,156, a significant increase from $1,591,494 in Q4 2023, reflecting a growth of 388%[27]. - The Phase 2a trial's dosing has been extended to 52 weeks to enhance long-term safety and efficacy data[8]. - Enrollment in the Phase 2a CBeyond trial of nimacimab exceeded the target, completing at 136 patients, with top-line data expected in late Q3/early Q4 2025[6]. - The company is advancing toward monthly dosing of nimacimab to improve patient experience and adherence[10]. Financial Position - Cash and cash equivalents totaled $68.4 million as of December 31, 2024, expected to fund operations through at least Q1 2027[19]. - Cash and cash equivalents increased to $68,415,741 as of December 31, 2024, up from $1,256,453 in 2023, showing a growth of 5,444%[29]. - Total assets rose to $72,763,773 in 2024, compared to $11,940,411 in 2023, marking an increase of 509%[29]. - Stockholders' equity improved to $68,151,724 in 2024, compared to a deficit of $(2,131,818) in 2023, indicating a turnaround in equity position[29]. - The company reported a total current liabilities of $4,338,887 in 2024, down from $13,900,999 in 2023, a decrease of 69%[29]. Other Financial Metrics - General and administrative (G&A) expenses for Q4 2024 were $4.6 million, up from $2.5 million in Q4 2023, mainly due to non-cash stock-based compensation and professional services[17]. - Skye achieved a $4.2 million gain from the partial derecognition of contingent liabilities and a $2.0 million gain from insurance recoveries in 2024[21]. - The weighted average shares of common stock outstanding increased to 39,968,601 in Q4 2024 from 12,343,269 in Q4 2023, an increase of 224%[27]. - The company did not incur any costs to acquire IPR&D assets in 2024, compared to $21,215,214 in 2023, indicating a strategic shift in asset acquisition[27]. - The company plans to present preclinical data at scientific conferences in Q2 2025, alongside an analyst event during the American Diabetes Association sessions[19].

[Part I](index=4&type=section&id=PART%20I) [Business](index=5&type=section&id=Item%201.%20Business) The company is a clinical-stage biotech firm developing its lead candidate, nimacimab, for obesity treatment - Skye Bioscience is a clinical-stage biotechnology company focusing on **GPCR-modulating molecules** to treat obesity, with its lead candidate being **nimacimab**, a CB1 receptor targeting antibody[15](index=15&type=chunk) - The company is conducting the **"CBeyond" Phase 2a trial** for nimacimab, with top-line data anticipated in **late Q3 or early Q4 of 2025**[16](index=16&type=chunk) **Development Pipeline Status** | MOA | Disease | Discovery | Preclinical | Ph1 | Ph2 | Ph3 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Nimacimab** | | | | | | | | CB1 Receptor Inhibitor | Obesity | | | ✓ | **►** | | - The company's intellectual property portfolio includes **3 granted U.S. patents** and **38 foreign patents** for nimacimab, with expiration dates between **2035 and 2036**[57](index=57&type=chunk)[58](index=58&type=chunk) - As of March 19, 2025, the company has **16 full-time employees**, four of whom hold a Ph.D or MD degree[117](index=117&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from its reliance on a single clinical candidate and its history of financial losses - Principal risk factors include dependence on third parties, a history of losses, need for additional financing, and reliance on **nimacimab's clinical success**[128](index=128&type=chunk) **Historical Financial Losses** | Metric | FY 2024 | FY 2023 | | :--- | :--- | :--- | | **Net Loss** | $26,567,123 | $37,644,784 | | **Accumulated Deficit (as of Dec 31, 2024)** | $130,949,672 | | - The company is **heavily dependent on the success of nimacimab**, its only product candidate in clinical development[131](index=131&type=chunk) - The company will require **substantial additional financing** to complete the development of nimacimab beyond the current Phase 2a trial[135](index=135&type=chunk)[136](index=136&type=chunk) - As of December 31, 2024, executive officers, directors, and principal stockholders collectively owned approximately **71% of the company's outstanding common stock**[285](index=285&type=chunk) [Unresolved Staff Comments](index=67&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments - None[320](index=320&type=chunk) [Cybersecurity](index=67&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cyber risk program based on the NIST framework, with oversight from the Audit Committee - The company's cyber risk management program is based on the **NIST Cybersecurity Framework** and includes annual third-party assessments[322](index=322&type=chunk) - The **Audit Committee** of the Board of Directors oversees the cybersecurity risk management program, receiving briefings at least annually[326](index=326&type=chunk) - While acknowledging the risk of future incidents, the company states that prior cybersecurity events have **not materially impacted** its business or financials[327](index=327&type=chunk) [Properties](index=68&type=section&id=Item%202.%20Properties) The company leases its principal executive and corporate offices in San Diego, California, until October 2026 - The company's principal executive offices are leased at 11250 El Camino Real Suite 100, San Diego, CA 92130, with the lease expiring on **October 31, 2026**[328](index=328&type=chunk) [Legal Proceedings](index=68&type=section&id=Item%203.%20Legal%20Proceedings) Material legal proceedings are detailed in Note 11 of the consolidated financial statements - For details on material legal proceedings, the report refers to **Note 11** of the financial statements[329](index=329&type=chunk) [Mine Safety Disclosures](index=68&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[330](index=330&type=chunk) [Part II](index=69&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=69&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "SKYE", and no cash dividends are anticipated - The company's common stock trades on the **Nasdaq Global Select Market** under the symbol **"SKYE"**[333](index=333&type=chunk) - As of March 19, 2025, there were **190 stockholders of record**[334](index=334&type=chunk) - The company has **never declared or paid a cash dividend** and does not expect to in the foreseeable future[335](index=335&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=69&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The net loss decreased in 2024 while operating expenses rose, and liquidity improved significantly from equity financings - In 2024, the company raised combined net proceeds of **$83.6 million** from two private placement equity financings[342](index=342&type=chunk) - The company **eliminated its ocular program (SBI-100 OE)** after a Phase 2a trial did not meet its primary endpoint, redirecting resources to its metabolic program[345](index=345&type=chunk) - In Q4 2024, the company recovered **$9 million in restricted cash** after a favorable appeal in a material litigation matter and collected an additional **$2 million** from its insurance carrier[347](index=347&type=chunk) **Comparison of Operating Expenses (2024 vs 2023)** | Expense Category | 2024 ($) | 2023 ($) | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | 18,701,694 | 5,819,461 | 12,882,233 | 221% | | Cost to acquire IPR&D asset | 0 | 21,215,214 | (21,215,214) | (100)% | | General and administrative | 17,725,741 | 7,852,340 | 9,873,401 | 126% | **Net Loss and Loss Per Share (2024 vs 2023)** | Metric | 2024 | 2023 | | :--- | :--- | :--- | | **Net Loss** | $(26,567,123) | $(37,644,784) | | **Loss Per Share (Basic & Diluted)** | $(0.73) | $(5.37) | **Summary of Cash Flows (2024 vs 2023)** | Cash Flow Activity | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | **Operating Activities** | (25,237,480) | (13,952,178) | | **Investing Activities** | (245,615) | 6,596,456 | | **Financing Activities** | 83,562,181 | 16,443,270 | [Financial Statements and Supplementary Data](index=78&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The financial statements show a reduced net loss and a shift from a stockholders' deficit to significant equity in 2024 **Consolidated Balance Sheet Highlights (as of Dec 31)** | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | 68,415,741 | 1,256,453 | | Total Assets | 72,763,773 | 11,940,411 | | Total Liabilities | 4,612,049 | 14,072,229 | | Total Stockholders' Equity (Deficit) | 68,151,724 | (2,131,818) | **Consolidated Statement of Operations Highlights (Year Ended Dec 31)** | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Research and development | 18,701,694 | 5,819,461 | | General and administrative | 17,725,741 | 7,852,340 | | Net loss | (26,567,123) | (37,644,784) | | Loss per common share (Basic & Diluted) | (0.73) | (5.37) | - The company acquired nimacimab through the BRB Acquisition on August 18, 2023, for total consideration valued at **$21.6 million**, recorded as an IPR&D expense[487](index=487&type=chunk)[489](index=489&type=chunk)[490](index=490&type=chunk) - In the Cunning Lawsuit, the company won an appeal, leading to the recovery of a **$9 million cash bond** and a **$4.2 million gain** from a change in legal contingency[570](index=570&type=chunk)[571](index=571&type=chunk) - The company settled a lawsuit with its D&O insurance carrier, Partner Re, for **$2 million**, recognized as income from insurance recovery in 2024[573](index=573&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=78&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item is not applicable to the company - Not applicable[392](index=392&type=chunk) [Controls and Procedures](index=78&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective - Management concluded that the company's **disclosure controls and procedures were effective** as of the end of the period covered by the report[393](index=393&type=chunk) - Based on an assessment using the **COSO 2013 framework**, management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[396](index=396&type=chunk)[397](index=397&type=chunk) [Other Information](index=79&type=section&id=Item%209B.%20Other%20Information) The company announced its 2025 Annual Meeting date and disclosed a director-affiliated Rule 10b5-1 stock sale plan - The 2025 Annual Meeting of Stockholders is scheduled for **June 6, 2025**[400](index=400&type=chunk) - On December 17, 2024, entities affiliated with a director entered into a **Rule 10b5-1 plan** to sell up to **2,000,000 shares** of common stock[404](index=404&type=chunk) [Part III](index=80&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=80&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, officers, and governance is incorporated by reference from the 2025 Proxy Statement - Information required by this item is **incorporated by reference** from the company's definitive Proxy Statement for the 2025 Annual Meeting[408](index=408&type=chunk) [Executive Compensation](index=80&type=section&id=Item%2011.%20Executive%20Compensation) Details regarding executive compensation are incorporated by reference from the company's 2025 Proxy Statement - Information required by this item is **incorporated by reference** from the company's definitive Proxy Statement for the 2025 Annual Meeting[409](index=409&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=80&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership information is incorporated by reference from the company's upcoming 2025 Proxy Statement - Information required by this item is **incorporated by reference** from the company's definitive Proxy Statement for the 2025 Annual Meeting[410](index=410&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=80&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2025 Proxy Statement - Information required by this item is **incorporated by reference** from the company's definitive Proxy Statement for the 2025 Annual Meeting[412](index=412&type=chunk) [Principal Accountant Fees and Services](index=80&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Details on principal accountant fees and services are incorporated by reference from the 2025 Proxy Statement - Information required by this item is **incorporated by reference** from the company's definitive Proxy Statement for the 2025 Annual Meeting[413](index=413&type=chunk) [Part IV](index=81&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=81&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) This section lists the consolidated financial statements, the independent auditor's report, and all filed exhibits - This section includes the consolidated financial statements of Skye Bioscience, Inc, and the report from its independent registered public accounting firm, **Marcum LLP**[416](index=416&type=chunk) - A comprehensive list of exhibits filed with the Form 10-K is provided, including merger agreements, bylaws, and financing agreements[579](index=579&type=chunk)[580](index=580&type=chunk) [Form 10-K Summary](index=115&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that no Form 10-K summary is provided - None[583](index=583&type=chunk)

SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ: SKYE) ("Skye" or the "Company"), a clinical stage biopharmaceutical company pioneering next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the fourth quarter and full year ended December 31, 2024, along with key accomplishments and upcoming milestones. "Skye's prime accomplishment in 2024 was the initiation and rapid advanceme ...

Core Viewpoint - Skye Bioscience, Inc. is set to discuss its 2024 fourth quarter and full-year financial results in a conference call on March 20, 2025, indicating a focus on transparency and investor engagement [1][2]. Company Overview - Skye Bioscience is a clinical-stage biotechnology company dedicated to developing new therapeutic pathways for obesity and metabolic health disorders through next-generation molecules that modulate G-protein coupled receptors [3]. - The company is conducting a Phase 2 clinical trial for nimacimab, an antibody that inhibits CB1, and is also exploring its combination with a GLP-1R agonist (Wegovy®) [3]. Financial Communication - An earnings press release will be issued after market close on March 20, 2025, and a live webcast of the conference call will be available on the Skye Investor Relations website [1][2].

Company Overview - Skye Bioscience, Inc. is a clinical-stage biopharmaceutical company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][3] - The company is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, and is also assessing its combination with a GLP-1R agonist (Wegovy®) [3] Industry Insights - The South by Southwest (SXSW) conference serves as a global platform for thought leaders and industry experts to discuss emerging trends in health and medtech, particularly in the context of weight loss medicine [2] - The panel session titled "Weighing in on Weight Loss Medicine" will explore the future of obesity management beyond GLP-1 drugs, indicating a shift towards innovative solutions in the obesity treatment landscape [2][1]

Company Overview - Skye Bioscience, Inc. is a clinical-stage biopharmaceutical company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][3] - The company is leveraging biologic targets with substantial human proof of mechanism to create first-in-class therapeutics with clinical and commercial differentiation [3] Clinical Development - Skye is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, specifically targeting obesity [3] - The trial is also assessing the combination of nimacimab with a GLP-1R agonist (Wegovy®) [3] Upcoming Events - Punit Dhillon, the CEO of Skye, will present a corporate overview at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, from 11:10 AM to 11:40 AM ET in Boston, MA [1][5] - A live and archived webcast of the presentation will be available on Skye's website [2]

Company Overview - Skye Bioscience, Inc. is a clinical-stage biopharmaceutical company focused on developing new therapeutic pathways for obesity and metabolic health disorders [2] - The company is working on next-generation molecules that modulate G-protein coupled receptors, aiming to create first-in-class therapeutics with clinical and commercial differentiation [2] Clinical Trials - Skye is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, specifically targeting obesity [2] - The trial is also evaluating the combination of nimacimab with a GLP-1R agonist, Wegovy® [2] Investor Engagement - Skye will participate in the BIO CEO & Investor Conference on February 10, 2025, focusing on obesity treatments [1] - The company will also present a corporate overview at the Oppenheimer 35th Healthcare Life Sciences Conference on February 12, 2025 [1]

Core Insights - Skye Bioscience is set to announce Phase 2 data for nimacimab, a first-in-class CB1 inhibitor, in 2025, which could significantly impact obesity treatment and weight loss [1][5] - The company aims to provide alternative therapeutic options for obesity, addressing limitations of current incretin therapies [2][3] Clinical Development - Skye has established a clear clinical development plan for nimacimab, with a focus on peripheral CB1 inhibition as a potential addition to obesity treatment options [3] - The CBeyond™ Phase 2 obesity trial has achieved 50% enrollment of the planned 120 patients, with interim data expected in Q2 2025 and topline weight loss data targeted for Q4 2025 [5][10] - The study design includes a randomized, double-blind, placebo-controlled approach, aiming for an 8% difference in mean weight loss compared to placebo at 26 weeks [5] Scientific Insights - Preliminary findings from preclinical studies indicate dose-dependent weight loss with nimacimab, showing significant fat mass loss while preserving lean mass [10] - The results suggest that peripheral CB1 inhibition is the primary driver of weight loss, contrasting with central CB1 inhibition, which may lead to adverse neuropsychiatric effects [10] Corporate Developments - Skye has strengthened its leadership team and established a clinical advisory board with leading obesity experts to enhance its strategic direction [3][10] - The company successfully raised $90 million in private placement equity financing, supporting its strategic initiatives [10]

Company Overview - Skye Bioscience, Inc. is a clinical-stage biopharmaceutical company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][3] - The company is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, and is also assessing its combination with a GLP-1R agonist (Wegovy®) [3] Upcoming Events - Skye will present a corporate overview at the 43rd Annual J.P. Morgan Healthcare conference on January 16, 2025, from 10:30 AM to 11:10 AM [1] Research and Development Focus - Skye's strategy involves leveraging biologic targets with substantial human proof of mechanism to develop first-in-class therapeutics with clinical and commercial differentiation [3] - The company aims to unlock new therapeutic pathways through the development of next-generation molecules that modulate G-protein coupled receptors [3]

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2024 were $4.9 million, up from $1.3 million in Q3 2023, primarily due to clinical and manufacturing costs associated with the Phase 2 trial for nimacimab [27] - General and administrative expenses increased to $4.6 million in Q3 2024 from $2.2 million in Q3 2023, driven by non-cash stock-based compensation and professional services [28] - The net loss for Q3 2024 was $3.9 million, significantly reduced from a net loss of $24.9 million in Q3 2023, largely due to the absence of a major acquisition expense [29] - Cash and cash equivalents as of September 30, 2024, were $76.5 million, with an expected increase in quarterly burn rate to approximately $9 million in 2025 [30][31] Business Line Data and Key Metrics Changes - The company is focused on advancing the Phase 2 obesity clinical trial named CBeyond, which is currently enrolling patients and tracking towards interim data announcement by Q2 2025 [19][20] - The CBeyond trial aims to demonstrate an 8% difference in mean weight loss using nimacimab versus placebo at 26 weeks, with secondary endpoints evaluating safety and tolerability [20][21] Market Data and Key Metrics Changes - The company is positioning nimacimab as a strong candidate in the anti-obesity medication landscape, aiming to establish itself as a leader in non-incretin metabolic therapies [22][39] - The competitive landscape includes incretin mimetics, with the company emphasizing the unique peripheral mechanism of nimacimab as a complementary alternative [58] Company Strategy and Development Direction - The company aims to create a comprehensive clinical pipeline in metabolic health, focusing on optimizing nimacimab's clinical profile and exploring additional GPCR targets [24][25] - The strategic roadmap over the next three years includes delivering key clinical and preclinical data while preparing for late-stage clinical development of nimacimab [41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of nimacimab to drive significant weight loss without neuropsychiatric adverse events, differentiating it from previous small molecule CB1 inhibitors [39][40] - The company is focused on regulatory approval for nimacimab as a monotherapy, while exploring combination therapies with GLP-1 drugs for future commercial opportunities [90] Other Important Information - The company has added key personnel to its team, including a Chief Medical Officer with extensive metabolic experience, to strengthen its operational capabilities [36] - The company is actively engaging with key opinion leaders (KOLs) to enhance understanding and support for its clinical data and mechanisms of action [52][56] Q&A Session Summary Question: Can you provide an update on CBeyond enrollment and expected data? - Management confirmed that enrollment is progressing well, with expectations to reach 50% enrollment before year-end, focusing on monotherapy weight loss as the primary endpoint [45][46] Question: What feedback was received from KOLs regarding preclinical data? - KOL feedback highlighted the importance of peripheral CB1 inhibition for weight loss, with positive responses to the preclinical efficacy of nimacimab [52][56] Question: How does the company view the commercial path for GLP-1 combinations? - The company sees potential for nimacimab as a complementary treatment alongside GLP-1 drugs, but emphasizes the primary focus on regulatory approval as a monotherapy [90] Question: What are the mechanisms behind neuropsychiatric adverse events in central CB1 targeting? - Management explained that central CB1 inhibition can lead to adverse events by blocking pathways that regulate mood and stress responses, which is not a concern with peripheral targeting [84][86] Question: Will further preclinical work be conducted comparing nimacimab with other CB1 modulators? - The company plans to continue preclinical studies to better understand nimacimab's mechanism and explore combinations with other anti-obesity medications [64][65]