Summary of Skye Bioscience FY Conference Call Company Overview - **Company**: Skye Bioscience (NasdaqGM:SKYE) - **Focus**: Development of innovative therapeutics targeting obesity through a CB1 antibody approach Key Points and Arguments Pipeline and Development - Skye is in **Phase 2a** development for an obesity treatment using a **CB1 antibody**, which is a non-incretin target, contrasting with the dominant incretin class (GLP-1) in the market [2][3] - The clinical readout for the lead program is expected in **late Q3 to early Q4 2025** [2] - The company is also focused on **lifecycle management** of lead assets and improving the **target product profile (TPP)**, including exploring less frequent dosing options [3][32] Market Insights - The obesity treatment market is described as **heterogeneous**, indicating that a one-size-fits-all approach is ineffective [4] - Approximately **70% of patients** discontinue current obesity drugs within the first year, primarily due to tolerability issues [6] - Skye aims to address the **maintenance population** and those who discontinue other treatments due to side effects [5] Competitive Positioning - NEMAZENMEB is positioned to target patients who discontinue drugs like **Zepbound** or **Wegovy**, with a focus on **combination therapies** that could enhance weight loss outcomes [8][17] - The company anticipates achieving **5% to 8% weight loss** at 26 weeks in its proof of concept study, with a goal of demonstrating a clear separation from placebo [14][15] Mechanism of Action - NEMAZENMEB operates through a **peripheral-driven mechanism**, focusing on metabolic functions outside the brain, which is expected to regulate appetite and improve glucose metabolism [9][10] - Evidence suggests that NEMAZENMEB can positively influence **lipid metabolism** and reduce inflammation, which are critical factors in obesity management [11][12] Safety and Efficacy - Skye emphasizes the importance of **neuropsychiatric safety**, especially given past issues with similar drugs like rimonabant [19][20] - The company has established a robust safety profile with no reported neuropsychiatric adverse events in early trials [20][21] Financial Position - As of June 30, Skye reported a cash balance of **$48 million**, which is expected to fund operations until **Q1 2027** [31] - The company is committed to maintaining low general and administrative costs while focusing on development [33] Future Milestones - Key upcoming milestones include the **top-line data release** in late Q3 to early Q4 2025 and decisions regarding the **Phase 2b study** [37][38] - The company is also exploring broader applications of its CB1 pathway research, potentially addressing various comorbidities associated with obesity [27][28] Additional Important Insights - Skye is open to exploring **combination therapies** with existing GLP-1 drugs, aiming for a product that could be administered less frequently while maintaining efficacy [29] - The company recognizes the competitive landscape of obesity treatments and aims to differentiate itself through unique mechanisms and improved patient outcomes [25][26]

Summary of Skye Bioscience (SKYE) Update / Briefing September 04, 2025 Company Overview - **Company**: Skye Bioscience (SKYE) - **Focus**: Development of Nimazumab, a monoclonal antibody targeting the CB1 receptor for obesity and metabolic disorders Key Industry Insights - **Clinical Trials**: Discussion centered around the CBEYOND Phase 2 trial, with a focus on the efficacy and safety of Nimazumab in treating obesity - **Mechanism of Action**: Nimazumab acts as a negative allosteric modulator of the CB1 receptor, designed for peripheral action, minimizing brain penetration and associated neuropsychiatric risks Core Points and Arguments 1. **Clinical Data Presentation**: New preclinical data was shared, indicating that Nimazumab reduces fat metabolism while preserving lean mass, improves glycemic control, and shows weight loss durability after treatment cessation [4][8][10] 2. **Weight Loss Efficacy**: In preclinical studies, Nimazumab demonstrated up to 24.2% weight loss in DIO mice, outperforming the small molecule monlunabant [26][27] 3. **Rebound Weight Gain**: Post-treatment weight regain was significantly lower with Nimazumab compared to monlunabant, indicating its potential for long-term weight maintenance [28][34] 4. **Combination Therapy Potential**: The combination of Nimazumab with tirzepatide showed promising results, achieving up to 44% weight loss, suggesting enhanced efficacy when used together [31][34] 5. **Safety Profile**: Emphasis on the reduced risk of neuropsychiatric side effects due to Nimazumab's limited brain penetration, a significant concern with previous CB1 antagonists [50][72] 6. **Tolerability**: The company aims for better gastrointestinal tolerability compared to existing GLP-1 therapies, which is crucial for patient adherence and long-term treatment success [49][52] Important but Overlooked Content 1. **Market Need**: There is a significant unmet need for more tolerable obesity treatments, as many patients discontinue current therapies due to side effects [18][82] 2. **Patient Feedback**: Surveys conducted with endocrinologists highlighted the demand for therapies that improve tolerability and support chronic use [17][18] 3. **Future Expectations**: The Phase 2 proof of concept readout is anticipated in late Q3 to early Q4 2025, with a focus on achieving 5-8% placebo-adjusted weight loss [11][45] 4. **Long-term Data**: The company is preparing for a 52-week data readout from the extension study, which will provide further insights into the long-term efficacy and safety of Nimazumab [43][44] Conclusion Skye Bioscience is positioning Nimazumab as a potentially groundbreaking treatment for obesity, with a focus on safety, tolerability, and efficacy. The upcoming clinical data will be critical in validating its therapeutic profile and addressing the significant market need for effective obesity treatments.

Core Insights - Skye Bioscience reported promising results from preclinical studies on nimacimab, indicating its potential as a superior treatment for obesity compared to existing therapies [1][5] Group 1: Study Findings - The first preclinical study showed that nimacimab demonstrated similar or better weight loss compared to monlunabant, with superior maintenance of weight loss post-treatment [1][6] - The second study indicated that nimacimab, when combined with tirzepatide, resulted in over 40% weight loss and limited rebound weight gain after treatment cessation [5][6] - Nimacimab is positioned as a potential standalone, combination, and maintenance therapy in the obesity drug development landscape [1][5] Group 2: Mechanism and Differentiation - Nimacimab is a peripherally-acting CB1-inhibiting monoclonal antibody that may offer a better safety and tolerability profile compared to small molecule inhibitors like monlunabant [6] - The mechanism of action for nimacimab suggests improved metabolic homeostasis and reduced compensatory rebound upon treatment withdrawal [3][6] - The ability to maintain weight loss after GLP-1 treatment aligns with real-world needs, addressing issues of durability and adherence [3][6] Group 3: Future Outlook - Skye plans to present these findings at a KOL event, discussing the potential of combining peripherally-acting CB1 antagonism with GLP-1 therapies to enhance weight loss outcomes [3][4] - Top-line data from the Phase 2 CBeyond study is expected to be reported in late Q3 or early Q4 2025, indicating ongoing development and potential market entry [5]

Core Insights - Skye Bioscience, Inc. has completed the treatment phase for the last patient in its Phase 2a CBeyond™ clinical trial evaluating nimacimab for obesity, with topline data expected in late Q3/early Q4 of 2025 [1][3] Group 1: Clinical Trial Details - The CBeyond™ Phase 2a trial is a randomized, double-blind, placebo-controlled study focusing on weight loss, safety, tolerability, and metabolic biomarkers in adults with obesity and overweight [2] - The primary endpoint of the trial is to compare weight change from baseline to 26 weeks between nimacimab and placebo [2] - An exploratory arm of the trial is assessing the combination of semaglutide (Wegovy®) with nimacimab versus semaglutide with placebo [2] Group 2: Study Progress and Future Plans - Skye has completed enrollment for a 26-week extension of the Phase 2a trial, which aims to provide data on 52 weeks of treatment with nimacimab, either as monotherapy or in combination with semaglutide [5] - Patients who completed the initial 26 weeks were eligible for the extension, potentially leading to a total treatment duration of 52 weeks followed by a 12-week follow-up [5] - Data from the extension study is expected to be reported in Q1 2026 [5] Group 3: Company Strategy and Market Context - Skye is focused on developing new therapeutic pathways for metabolic health, particularly through the modulation of G-protein coupled receptors [6] - The company believes that peripheral CB1 inhibition via an antibody presents a promising alternative to existing GLP-1 weight loss drugs, which may not meet all patients' needs [4] - Skye aims to advance nimacimab as a potential new therapeutic option for obesity and overweight, addressing limitations of current treatments [4]

Core Insights - Skye Bioscience, Inc. will host a virtual KOL event on September 4, 2025, to discuss the upcoming topline results from the Phase 2a CBeyond™ trial of nimacimab, a first-in-class peripheral CB1 antibody for obesity [1][2] - The event aims to provide clarity on what constitutes success in the proof-of-concept study, focusing on safety, tolerability, and new preclinical insights related to nimacimab [2][7] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][8] - The company is conducting a Phase 2a clinical trial for nimacimab, which is designed to inhibit peripheral CB1 and is also assessing its combination with a GLP-1R agonist [8] KOL Event Highlights - The event will feature discussions with leading obesity experts, including Skye's CEO, Punit Dhillon, who will address the significance of safety and tolerability benchmarks in the obesity treatment landscape [2][7] - Key opinion leaders participating include Dr. Kevin Cannon, Dr. Sean Wharton, and Dr. Marcus Goncalves, who bring extensive experience in metabolic health and obesity research [3][4][6] Research Focus - The event will cover the mechanism and potential role of peripheral CB1 inhibition as a differentiated anti-obesity therapeutic pathway [7] - Newly generated preclinical data with nimacimab will be highlighted, contributing to the understanding of its potential advancement into Phase 2b development [2][7]

Core Insights - Skye Bioscience, Inc. is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [4] - The company is conducting a Phase 2a clinical trial for nimacimab, an antibody that inhibits CB1, and is also assessing its combination with a GLP-1R agonist [4] Investment Conferences - Skye will participate in several investment conferences, including: - Cantor Global Healthcare Conference on September 5, 2025 - H.C. Wainwright Global Investment Conference on September 8, 2025 - Morgan Stanley Global Healthcare Conference on September 10, 2025 [6] Medical/Scientific Conferences - Skye will also present at medical conferences, including: - Obesity Science & Innovation on September 16, 2025, with a keynote panel discussing pipeline priorities in obesity therapeutics - European Association for the Study of Diabetes Annual Meeting on September 19, 2025, presenting a study on the safety and tolerability of nimacimab in subjects with metabolic associated fatty liver disease [6]

Financial Data and Key Metrics Changes - The company ended the second quarter with cash and cash equivalents totaling $48.6 million, with guidance indicating that current capital is projected to fund operations through at least Q1 2027 [29] - Research and development expenses for the three months ended June 30, 2025, were $14.3 million, compared to $4.1 million for the same period in 2024, primarily due to increased clinical trial costs and contract manufacturing [30] - The net loss for the three months ended June 30, 2025, totaled $17.6 million, compared to $7.9 million for the same period in 2024 [31] Business Line Data and Key Metrics Changes - The phase two a CBEYOND trial is advancing as planned, with enrollment completed ahead of schedule, and the 26-week visit for the last patient projected to occur shortly [7] - Approximately 50% of patients from the original study are eligible for enrollment in the extension study, with optimism that a majority will choose to participate [7][56] Market Data and Key Metrics Changes - The company identifies three market opportunities for Nimasumab: as a monotherapy for patients who cannot tolerate incretin therapeutics, as a combination partner to amplify efficacy, and as a maintenance therapy to sustain weight loss [22] - The obesity treatment market is evolving beyond caloric restriction to address broader metabolic impacts, indicating a shift in treatment paradigms [26] Company Strategy and Development Direction - The company aims to position Nimasumab as a next-generation backbone candidate for durable and combinable obesity care, addressing the limitations of current therapies [25] - The focus is on expanding therapeutic options in obesity treatment, particularly for patients who discontinue existing therapies due to side effects [24] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the importance of disciplined execution and operational rigor as the company enters a crucial execution period [32] - The upcoming top-line data from the CBEYOND trial is expected to provide insights into the efficacy and safety of Nimasumab, guiding future development [34] Other Important Information - The company plans to host a KOL event at Nasdaq on September 4, focusing on clinical data expectations and market positioning [33] - The phase one SADMAD MAFLD data will be presented at EASD on September 19, reinforcing hepatic and metabolic benefits [33] Q&A Session Summary Question: What accounted for the increase in R&D expenses? - The increase was primarily due to contract manufacturing costs related to the phase two a resupply and the supply for the phase two b trial [41] Question: What are the expectations for Nimasumab's weight loss efficacy at week 26? - The goal is to demonstrate a clinically meaningful weight loss separation from placebo, ideally in the range of 5% to 8% [46] Question: What is the expected discontinuation rate within 26 weeks? - The company expects a discontinuation rate similar to trends seen in other obesity studies, around 25% to 30% [50] Question: What is the protocol for the independent board overseeing trial safety? - The board meets quarterly and reviews all adverse events and serious adverse events reported during the study [73] Question: Will there be a follow-up period after the extension study to track durability of weight loss? - Yes, there will be a 13-week follow-up period after the extension study, with data expected in 2026 [82]

Clinical Progress - Top-line data from the CBeyond study is expected in late Q3/early Q4[15] - A KOL event is scheduled for September 2025 to discuss the mechanism, Phase 2a clinical data expectations, and market positioning[15, 49] Nimacimab's Differentiation and Mechanism - Nimacimab exhibits significantly less brain penetration compared to small molecule CB1 inhibitors[18] - Nimacimab retains potency even in the presence of competition, unlike small molecules[20] - Preclinical data suggests nimacimab enhances weight loss when combined with low-dose tirzepatide[26] - Preclinical data suggests nimacimab prevents weight rebound and shows potential as maintenance therapy, with tirzepatide rebound at 29.7% and nimacimab maintenance at 12.8% in Phase B[31, 33] Market Opportunity - Nearly two-thirds (66.67%) of patients discontinue GLP-1 RA therapy after one year, and over 80% discontinue after two years, highlighting a therapeutic gap[36] - The company believes nimacimab represents a potential multi-billion dollar opportunity in monotherapy, maintenance, and combination therapy for obesity[37]

[Executive Summary](index=1&type=section&id=Executive%20Summary) Skye Bioscience is a clinical-stage biotech company developing next-generation molecules for obesity and related diseases, with CEO Punit Dhillon anticipating Phase 2a data for nimacimab and highlighting its unique CB1 mechanism [Company Profile](index=1&type=section&id=Company%20Profile) Skye Bioscience is a clinical-stage biotechnology company focused on developing next-generation molecules regulating G protein-coupled receptors to treat obesity, overweight, and related conditions, currently conducting a Phase 2a clinical trial for nimacimab - Skye Bioscience is a clinical-stage biotechnology company dedicated to developing next-generation molecules that modulate G protein-coupled receptors for the treatment of obesity, overweight, and related diseases[2](index=2&type=chunk)[17](index=17&type=chunk) - The company is conducting a Phase 2a clinical trial for nimacimab, a peripherally restricted CB1 negative allosteric modulating antibody[2](index=2&type=chunk)[17](index=17&type=chunk) [CEO Statement & Strategic Vision](index=1&type=section&id=CEO%20Statement%20%26%20Strategic%20Vision) CEO Punit Dhillon anticipates top-line data from the CBeyond Phase 2a study, has initiated a 26-week extension, and highlights nimacimab's distinct CB1 mechanism as a potential monotherapy or combination therapy to meet market demands for broader metabolic benefits, durability, and combinability - The company anticipates 26-week top-line data from the CBeyond Phase 2a study in **late Q3/early Q4 2025**, and has initiated a 26-week extension study that could generate up to 52 weeks of data in 2026[3](index=3&type=chunk) - CEO Punit Dhillon believes nimacimab's peripherally restricted CB1 mechanism offers a fundamentally different approach, potentially providing advantages as a monotherapy or combination therapy without exacerbating gastrointestinal side effects[3](index=3&type=chunk) - The company observes a growing market demand for therapies offering broader metabolic benefits, improved durability, and combinability, believing nimacimab holds a unique position in obesity care[3](index=3&type=chunk) [Clinical & Research Development Highlights](index=1&type=section&id=Clinical%20%26%20Research%20Development%20Highlights) The CBeyond Phase 2a obesity trial is progressing with top-line data expected in late 2025, while preclinical data underscores nimacimab's differentiated non-incretin mechanism, showing significant weight loss and synergistic potential [CBeyond Phase 2a Obesity Trial Updates](index=1&type=section&id=CBeyond%20Phase%202a%20Obesity%20Trial%20Updates) Top-line data for the CBeyond Phase 2a study is expected in late Q3/early Q4 2025, with a 26-week extension study initiated for long-term data, and the independent Data Safety Monitoring Board has found no issues - Top-line data from the CBeyond Phase 2a study is anticipated in **late Q3/early Q4 2025**[3](index=3&type=chunk)[5](index=5&type=chunk) - A 26-week extension study began enrolling patients in July, including combination and monotherapy arms, expected to provide up to **52 weeks of safety and efficacy data**[5](index=5&type=chunk)[6](index=6&type=chunk) - The independent Data Safety Monitoring Board has completed four unblinded reviews, finding no safety concerns, and the study continues as per protocol[5](index=5&type=chunk)[6](index=6&type=chunk) [Preclinical Data & Nimacimab's Differentiated Profile](index=1&type=section&id=Preclinical%20Data%20%26%20Nimacimab's%20Differentiated%20Profile) Preclinical data demonstrates nimacimab's non-incretin mechanism with significant differentiation, including independent weight loss, synergistic effects with tirzepatide, positive impacts on appetite-regulating hormones and glucose control, and improved lipid metabolism, supporting its potential for combination therapy and weight maintenance - Preclinical data highlights nimacimab's key differentiated features as a non-incretin mechanism, including independent and meaningful weight loss, and additive weight loss exceeding **30%** when combined with the dual GLP-1/GIP agonist tirzepatide[5](index=5&type=chunk)[8](index=8&type=chunk) - Nimacimab modulates key appetite-regulating hormones (increasing GLP-1, decreasing leptin and resistin), improves glycemic control (lowering fasting glucose and insulin levels), and regulates lipid metabolism (reducing serum cholesterol, steatosis, inflammation, and liver fibrosis)[8](index=8&type=chunk) - As an allosteric inhibitor, nimacimab demonstrates greater potency and therapeutic window compared to small molecule CB1 inverse agonists, with its unique binding mechanism allowing effective CB1 inhibition even at elevated CB1 ligand levels[8](index=8&type=chunk) - New DIO (diet-induced obesity) mouse study data shows nimacimab combined with a suboptimal dose of tirzepatide achieved **44% weight loss**, outperforming single agents or optimal dose tirzepatide[9](index=9&type=chunk) - Nimacimab demonstrated superior weight loss durability post-cessation compared to incretin therapies, with the treatment group rebounding only **7.4%** after 24 days, versus **29.7%** for the low-dose tirzepatide group[9](index=9&type=chunk) - Using nimacimab alone after tirzepatide or combination therapy significantly reduced weight regain, reinforcing its potential as a weight maintenance therapy post-incretin treatment[9](index=9&type=chunk) [Corporate & Operational Updates](index=2&type=section&id=Corporate%20%26%20Operational%20Updates) Skye Bioscience expanded its team and successfully produced its first batch of nimacimab drug product, while also planning a KOL event in September 2025 to discuss Phase 2a data [Team Expansion](index=4&type=section&id=Team%20Expansion) Skye Bioscience expanded its team by 20 employees in Q2, enhancing expertise in regulatory affairs, quality assurance, clinical operations, and CMC, including hiring a VP of CMC to support clinical development and manufacturing - In Q2, Skye Bioscience increased its headcount to **20 employees**, adding expertise in regulatory affairs, quality assurance, clinical operations, and CMC[10](index=10&type=chunk) - The company hired a Vice President of CMC to align with its advancement of clinical development and manufacturing readiness[10](index=10&type=chunk) [Manufacturing Updates](index=4&type=section&id=Manufacturing%20Updates) The company successfully produced its first batch of nimacimab drug product since acquisition to supplement Phase 2a clinical trials and initiated formulation development with Arecor Therapeutics plc for higher concentration formulations - The company successfully manufactured and released its first batch of drug product since acquiring nimacimab, intended to supplement clinical trial material for the Phase 2a study[15](index=15&type=chunk) - The company initiated a formulation development collaboration with Arecor Therapeutics plc to identify and develop higher concentration nimacimab formulations[15](index=15&type=chunk) [Investor Relations & Events](index=2&type=section&id=Investor%20Relations%20%26%20Events) Skye plans a Key Opinion Leader (KOL) event on September 4, 2025, to discuss Phase 2a top-line data and held a conference call on August 7, 2025, for Q2 earnings - Skye plans to host a Key Opinion Leader (KOL) event on **September 4, 2025**, at Nasdaq to discuss Phase 2a top-line data[7](index=7&type=chunk) - The company hosted a conference call on **August 7, 2025**, to discuss its Q2 2025 financial results[15](index=15&type=chunk) [Second Quarter 2025 Financial Results](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Results) As of June 30, 2025, the company held $48.6 million in cash, with Q2 R&D expenses significantly increasing to $14.3 million, leading to an expanded net loss of $17.6 million [Balance Sheet and Cash Flow](index=4&type=section&id=Balance%20Sheet%20and%20Cash%20Flow) As of June 30, 2025, the company held $48.6 million in cash, cash equivalents, and short-term investments, projecting sufficient capital to fund operations and key clinical milestones through Q1 2027, including Phase 2a completion and partial Phase 2b manufacturing and clinical activities Cash, Cash Equivalents, and Short-Term Investments | Indicator | Amount (Million USD) | | :--- | :--- | | As of June 30, 2025 | 48.6 | - The company anticipates its existing capital is sufficient to support projected operations and key clinical milestones through **Q1 2027**, including completion of the nimacimab Phase 2a study and partial Phase 2b manufacturing and clinical activities[11](index=11&type=chunk) [Operating Results](index=4&type=section&id=Operating%20Results) Q2 2025 R&D expenses significantly increased to $14.3 million due to contract manufacturing and clinical trial costs, while G&A expenses slightly decreased to $3.9 million, leading to an expanded net loss of $17.6 million, including $4.2 million in non-cash stock-based compensation [Research and Development Expenses](index=4&type=section&id=Research%20and%20Development%20Expenses) Q2 2025 R&D expenses were $14.3 million, a significant increase from $4.1 million in Q2 2024, primarily driven by contract manufacturing, nimacimab clinical trial costs, discovery R&D, and personnel expenses Research and Development Expenses (Three Months Ended) | Indicator | June 30, 2025 (USD) | June 30, 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $14,337,753 | $4,078,751 | Increased 251.5% | - The increase in R&D expenses is primarily attributable to contract manufacturing, nimacimab clinical study related clinical trial costs, discovery R&D expenses, and personnel and stock-based compensation expenses[12](index=12&type=chunk) [General and Administrative Expenses](index=4&type=section&id=General%20and%20Administrative%20Expenses) Q2 2025 G&A expenses were $3.9 million, a decrease from $4.3 million in Q2 2024, mainly due to reduced general business and legal professional fees, partially offset by increased personnel, consulting, and investor relations costs General and Administrative Expenses (Three Months Ended) | Indicator | June 30, 2025 (USD) | June 30, 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | G&A Expenses | $3,906,172 | $4,326,820 | Decreased 9.7% | - The decrease in G&A expenses is primarily due to reduced general business and legal professional fees, partially offset by increases in personnel and stock-based compensation expenses, consulting and advisory fees, and investor relations costs[13](index=13&type=chunk) [Net Loss](index=4&type=section&id=Net%20Loss) Q2 2025 net loss expanded to $17.6 million from $7.9 million in Q2 2024, with non-cash stock-based compensation expenses remaining relatively stable at $4.2 million Net Loss (Three Months Ended) | Indicator | June 30, 2025 (USD) | June 30, 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Net Loss | $(17,624,872) | $(7,902,816) | Loss expanded 123.0% | | Non-Cash Stock-Based Compensation Expense | $4,200,000 | $4,300,000 | Decreased 2.3% | [About Skye Bioscience](index=5&type=section&id=About%20Skye%20Bioscience) Skye Bioscience aims to unlock new therapeutic pathways for metabolic health by developing next-generation molecules regulating G protein-coupled receptors, focusing on clinically and commercially differentiated first-in-class therapies, currently advancing nimacimab in a Phase 2a trial - Skye focuses on unlocking new therapeutic pathways for metabolic health by developing next-generation molecules that modulate G protein-coupled receptors[17](index=17&type=chunk) - The company's strategy is to leverage biologically validated human targets to develop clinically and commercially differentiated first-in-class therapies[17](index=17&type=chunk) - Skye is conducting a Phase 2a clinical trial for nimacimab, an antibody that acts through peripheral CB1 inhibition, and is evaluating its combination with a GLP-1R agonist (Wegovy®)[17](index=17&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding preclinical data inferences, nimacimab's efficacy, Phase 2a data release timelines, cash flow projections, and high-concentration formulation development, which are subject to risks and uncertainties that could cause actual results to differ materially - This press release contains forward-looking statements regarding preclinical data inferences, nimacimab's efficacy and therapeutic potential as a monotherapy or combination therapy, the timing of Phase 2a obesity study top-line data release, patient enrollment and data release timing for the Phase 2a extension study, the company's cash flow, and expectations for developing high-concentration nimacimab formulations with manufacturing partners[18](index=18&type=chunk) - These forward-looking statements are based on management's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated[18](index=18&type=chunk) - Risks and uncertainties include assumptions and risks regarding cash flow guidance, capital resources potentially being depleted sooner than anticipated, preclinical study results not predicting future trial outcomes, delays or difficulties in clinical trial patient enrollment or retention, reliance on third-party contract manufacturing organizations, and industry competition[18](index=18&type=chunk)[19](index=19&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) This section presents the unaudited consolidated statements of operations and balance sheets for Skye Bioscience, detailing financial performance and position for the periods ended June 30, 2025, and December 31, 2024 [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations for Skye Bioscience and its subsidiaries present financial data for the three and six months ended June 30, 2025, and 2024, including key metrics such as R&D expenses, G&A expenses, operating loss, and net loss Consolidated Statements of Operations (Unaudited) | Indicator | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | :--- | :--- | | Research and Development Expenses | $14,337,753 | $4,078,751 | $21,535,010 | $6,025,201 | | General and Administrative Expenses | $3,906,172 | $4,326,820 | $8,468,477 | $8,532,620 | | Total Operating Expenses | $18,243,925 | $8,405,571 | $30,003,487 | $14,557,821 | | Operating Loss | $(18,243,925) | $(8,405,571) | $(30,003,487) | $(14,557,821) | | Net Loss | $(17,624,872) | $(7,902,816) | $(28,728,191) | $(12,922,347) | | Basic Loss Per Share | $(0.44) | $(0.20) | $(0.72) | $(0.39) | | Diluted Loss Per Share | $(0.44) | $(0.20) | $(0.72) | $(0.39) | [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets for Skye Bioscience and its subsidiaries detail assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024, including cash and cash equivalents, short-term investments, total assets, total liabilities, and total stockholders' equity Consolidated Balance Sheets | Indicator | June 30, 2025 (Unaudited) (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and Cash Equivalents | $23,838,244 | $68,415,741 | | Short-Term Investments | $24,747,039 | — | | Total Current Assets | $50,582,518 | $70,827,247 | | Total Assets | $52,160,911 | $72,763,773 | | **Liabilities and Stockholders' Equity** | | | | Total Current Liabilities | $8,311,708 | $4,338,887 | | Total Liabilities | $8,484,202 | $4,612,049 | | Total Stockholders' Equity | $43,676,709 | $68,151,724 | | Total Liabilities and Stockholders' Equity | $52,160,911 | $72,763,773 | [Contacts](index=9&type=section&id=Contacts) This section provides contact information for Skye Bioscience's investor relations and media inquiries, including email addresses and phone numbers - Investor Relations contacts: ir@skyebioscience.com, (858) 410-0266 (Skye Bioscience); mmoyer@lifesciadvisors.com, (617) 308-4306 (LifeSci Advisors, Mike Moyer)[24](index=24&type=chunk) - Media Inquiries contacts: mfitzhugh@lifescicomms.com, (628) 234-3889 (LifeSci Communications, Michael Fitzhugh)[24](index=24&type=chunk)

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Skye Bioscience's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and stockholders' equity, with detailed notes for periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased by $20.6 million, driven by reduced cash and increased short-term investments, while liabilities rose and equity fell by $24.5 million | Metric | June 30, 2025 (Unaudited) ($) | December 31, 2024 ($) | | :-------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $23,838,244 | $68,415,741 | | Short-term investments | $24,747,039 | — | | Total current assets | $50,582,518 | $70,827,247 | | Total assets | $52,160,911 | $72,763,773 | | Total current liabilities | $8,311,708 | $4,338,887 | | Total liabilities | $8,484,202 | $4,612,049 | | Total stockholders' equity | $43,676,709 | $68,151,724 | - Cash and cash equivalents decreased by **$44.58 million** from December 31, 2024, to June 30, 2025, while short-term investments of **$24.75 million** were acquired[11](index=11&type=chunk) - Total current liabilities increased by approximately **$3.97 million**, driven by increases in accounts payable and other current liabilities[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss significantly increased for both three and six months ended June 30, 2025, primarily due to higher research and development expenses for nimacimab | Metric (Unaudited) | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | R&D Expenses | $14,337,753 | $4,078,751 | $21,535,010 | $6,025,201 | | G&A Expenses | $3,906,172 | $4,326,820 | $8,468,477 | $8,532,620 | | Total Op. Expenses | $18,243,925 | $8,405,571 | $30,003,487 | $14,557,821 | | Operating Loss | $(18,243,925) | $(8,405,571) | $(30,003,487) | $(14,557,821) | | Net Loss | $(17,624,872) | $(7,902,816) | $(28,728,191) | $(12,922,347) | | Basic EPS | $(0.44) | $(0.20) | $(0.72) | $(0.39) | - Research and development expenses increased by **252%** for the three months and **257%** for the six months ended June 30, 2025, compared to the same periods in 2024, primarily due to nimacimab clinical trial and manufacturing costs[13](index=13&type=chunk)[74](index=74&type=chunk)[81](index=81&type=chunk) - Net loss more than **doubled** for both the three-month and six-month periods year-over-year[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash and cash equivalents decreased significantly due to increased cash used in operations and substantial outflows for investing activities, including short-term investments | Cash Flow Activity (Unaudited) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating | $(19,931,667) | $(11,801,659) | | Net cash (used in) provided by investing | $(24,663,988) | $1,109,497 | | Net cash provided by financing | $18,158 | $83,556,563 | | Net (decrease) increase in cash | $(44,577,497) | $72,864,401 | | Cash, cash equivalents, end of period | $23,838,244 | $83,201,056 | - Cash used in operating activities increased by approximately **$8.13 million**, reflecting higher net losses and changes in working capital[16](index=16&type=chunk)[95](index=95&type=chunk)[98](index=98&type=chunk) - Investing activities shifted from a net cash inflow of **$1.11 million** in 2024 to a net cash outflow of **$24.66 million** in 2025, largely due to the purchase of short-term investments[16](index=16&type=chunk)[99](index=99&type=chunk) - Financing activities provided significantly less cash in 2025 (**$18,158**) compared to 2024 (**$83,556,563**), as the prior period included substantial proceeds from PIPE financings[16](index=16&type=chunk)[100](index=100&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from $68.15 million to $43.68 million, primarily due to net loss, partially offset by stock-based compensation | Metric | January 1, 2025 ($) | June 30, 2025 ($) | | :-------------------------- | :-------------- | :------------ | | Total Stockholders' Equity | $68,151,724 | $43,676,709 | | Accumulated Deficit | $(130,949,672) | $(159,677,863)| | Additional Paid-In Capital | $199,070,421 | $203,323,584 | | Metric | January 1, 2024 ($) | June 30, 2024 ($) | | :-------------------------- | :-------------- | :------------ | | Total Stockholders' Equity | $(2,131,818) | $72,809,051 | | Accumulated Deficit | $(104,382,549) | $(117,304,896)| | Additional Paid-In Capital | $102,238,382 | $190,085,879 | - Net loss for the six months ended June 30, 2025, was **$28,728,191**, contributing to the increase in accumulated deficit[17](index=17&type=chunk) - Stock-based compensation expense totaled **$4,235,018** for the six months ended June 30, 2025, increasing additional paid-in capital[17](index=17&type=chunk)[40](index=40&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context for the financial statements, detailing operations, accounting policies, fair value, assets, liabilities, equity, expenses, legal contingencies, and segment reporting [1. Organization, Basis of Presentation and Significant Accounting Policies](index=8&type=section&id=1.%20Organization%2C%20Basis%20of%20Presentation%20and%20Significant%20Accounting%20Policies) Skye Bioscience is a clinical-stage biotechnology company developing nimacimab for obesity, with no current revenue, and adopted ASU 2023-09 on income tax disclosures - Skye Bioscience is a clinical-stage biotechnology company developing next-generation molecules to treat obesity, overweight, and related conditions, with **nimacimab** as its lead candidate[18](index=18&type=chunk)[57](index=57&type=chunk) - The company has not yet realized revenue from its principal operations and does not expect to for several years[19](index=19&type=chunk)[63](index=63&type=chunk) - The company adopted ASU 2023-09, 'Improvements to Income Tax Disclosures,' as of January 1, 2025, and is evaluating its impact on the upcoming annual filing[25](index=25&type=chunk) [2. Fair Value Measurement](index=9&type=section&id=2.%20Fair%20Value%20Measurement) Financial instruments measured at fair value totaled $44.27 million, comprising Level 1 money market funds and U.S. Treasury Obligations as of June 30, 2025 | Asset Category | Valuation Hierarchy | Total Fair Value as of June 30, 2025 ($) | | :------------- | :------------------ | :----------------------------------- | | Money Market Funds | Level 1 | $19,527,439 | | U.S. Treasury Obligations | Level 1 | $24,747,039 | | Total cash equivalents and marketable securities | | $44,274,478 | [3. Prepaid Expenses, Other Current Assets and Liabilities](index=10&type=section&id=3.%20Prepaid%20Expenses%2C%20Other%20Current%20Assets%20and%20Liabilities) Prepaid expenses and other current liabilities significantly increased due to higher clinical and R&D costs, while other current assets, mainly vendor deposits, decreased | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :-------------- | :---------------- | | Prepaid clinical expenses | $710,253 | $13,078 | | Total prepaid expenses | $1,263,812 | $201,962 | | Vendor deposits | $565,831 | $1,997,274 | | Total other current assets | $733,423 | $2,209,544 | | R&D costs (Other current liabilities) | $1,858,242 | $325,415 | | Total other current liabilities | $2,220,063 | $654,201 | - Prepaid clinical expenses saw a substantial increase from **$13,078** to **$710,253**[28](index=28&type=chunk) - Vendor deposits decreased from **$1,997,274** to **$565,831**[28](index=28&type=chunk) - Accrued research and development costs within other current liabilities increased from **$325,415** to **$1,858,242**[28](index=28&type=chunk) [4. Warrants](index=11&type=section&id=4.%20Warrants) As of June 30, 2025, 11,799,016 fully vested warrants were outstanding, including pre-funded warrants from January 2024, with various exercise prices | Source | Exercise Price ($) | Remaining Contractual Term (Years) | Number of Warrants Outstanding | | :-------------------------------------- | :------------- | :--------------------------------- | :----------------------------- | | January 2024 Pre-Funded Warrants Common Stock | $0.001 | Indefinite | 8,677,166 | | August 2023 PIPE Financing Common Stock Warrants | $5.16 | 8.13 | 2,325,537 | | Total warrants outstanding as of June 30, 2025 | | | 11,799,016 | - All warrants outstanding as of June 30, 2025, are **fully vested**[29](index=29&type=chunk) [5. Stock-Based Compensation](index=11&type=section&id=5.%20Stock-Based%20Compensation) The company maintains equity incentive plans, granting stock options and RSUs; stock-based compensation expense was $4.24 million, with $13.71 million unrecognized as of June 30, 2025 - As of June 30, 2025, **324,615 shares** were available for future grant under the Amended and Restated Plan, and **142,500 shares** under the Inducement Plan[33](index=33&type=chunk)[34](index=34&type=chunk) | Metric | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------- | :----------------------------- | :----------------------------- | | Stock-based compensation expense | $4,235,018 | $4,306,653 | | R&D stock-based compensation | $1,008,606 | $695,719 | | G&A stock-based compensation | $3,226,412 | $3,610,934 | - The total unrecognized compensation cost was **$13,710,239** as of June 30, 2025, to be recognized over a weighted average period of **2.71 years**[40](index=40&type=chunk) [6. Loss Per Share of Common Stock](index=13&type=section&id=6.%20Loss%20Per%20Share%20of%20Common%20Stock) Basic and diluted net loss per share was $(0.44) for three months and $(0.72) for six months, with anti-dilutive common stock equivalents excluded | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(17,624,872) | $(7,902,816) | $(28,728,191) | $(12,922,347) | | Weighted average common shares outstanding | 39,659,266 | 38,669,330 | 39,655,597 | 33,334,616 | | Basic & Diluted EPS | $(0.44) | $(0.20) | $(0.72) | $(0.39) | - Outstanding stock options (**4,523,762**), warrants (**3,121,850**), and unvested restricted stock units (**499,363**) were anti-dilutive and excluded from diluted EPS calculations for the six months ended June 30, 2025[41](index=41&type=chunk) [7. Contingencies](index=13&type=section&id=7.%20Contingencies) A legal proceeding with a former employee was remanded for a new trial in September 2025, with the estimated legal contingency revised to $1.81 million as of June 30, 2025 - The Ninth Circuit Court of Appeals vacated the judgment in the Cunning Lawsuit in October 2024 and remanded the case for a new trial, scheduled for **September 2025**[44](index=44&type=chunk) - As a result of the appeal, the company recovered a **$9,080,202 bond** related to the judgment and reversed accrued interest, recognizing a gain of **$4,234,717**[44](index=44&type=chunk)[45](index=45&type=chunk) - The estimated legal contingency, including accrued legal expenses, was **$1,806,065** as of June 30, 2025[45](index=45&type=chunk) [8. Segment Reporting](index=14&type=section&id=8.%20Segment%20Reporting) Skye Bioscience operates as a single R&D segment for obesity, with expenses disaggregated to show a significant increase in nimacimab-related clinical development costs - The company operates in one business segment: research and development activities related to developing medicine for obesity and other metabolic diseases[47](index=47&type=chunk) | R&D Expense Category | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | nimacimab (External clinical) | $11,720,218 | $1,649,326 | $16,638,640 | $1,805,093 | | Total External clinical development | $11,720,218 | $2,762,783 | $16,640,881 | $3,812,910 | | Personnel related & stock-based comp. | $1,408,024 | $844,863 | $2,745,773 | $1,656,652 | | Other R&D expenses | $1,209,511 | $471,105 | $2,148,356 | $555,639 | | Total R&D expenses | $14,337,753 | $4,078,751 | $21,535,010 | $6,025,201 | - External clinical development expenses for **nimacimab** increased substantially, reflecting the focus on its Phase 2a clinical trial[49](index=49&type=chunk) [9. Subsequent Events](index=15&type=section&id=9.%20Subsequent%20Events) After June 30, 2025, Skye Bioscience granted 160,000 stock options to employees under its Amended and Restated Omnibus Equity Incentive Plan - **160,000 stock options** were granted to employees after June 30, 2025[51](index=51&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Skye Bioscience's financial condition and operations, focusing on nimacimab's progress, changes in expenses, other income/expense, liquidity, and future capital needs [SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS](index=16&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD%20LOOKING%20STATEMENTS) This cautionary statement advises against undue reliance on forward-looking statements, which involve substantial risks and uncertainties, as actual results may differ materially - The report contains forward-looking statements subject to substantial risks and uncertainties, and actual results may differ materially[53](index=53&type=chunk) - The company assumes no obligation to update forward-looking statements, except as required by law[54](index=54&type=chunk) [Overview](index=16&type=section&id=Overview) Skye Bioscience is a clinical-stage biotech developing nimacimab for obesity, with Phase 2a trial data expected late Q3/early Q4 2025, supported by promising preclinical results - Skye Bioscience is a clinical-stage biotechnology company developing **nimacimab** for obesity and overweight, targeting the CB1 receptor[57](index=57&type=chunk) - The company is conducting a Phase 2a proof-of-concept clinical trial (CBeyond) of nimacimab as a subcutaneous injectable, both as monotherapy and in combination with a GLP-1 receptor agonist[58](index=58&type=chunk) - Top-line readout from the CBeyond study is anticipated **late in the third quarter or early in the fourth quarter of 2025**[58](index=58&type=chunk) - Preclinical data showed nimacimab in combination with tirzepatide outperformed either agent alone in weight loss and demonstrated durability as a monotherapy or maintenance therapy post-incretin treatment[60](index=60&type=chunk)[61](index=61&type=chunk) [Financial Overview](index=17&type=section&id=Financial%20Overview) Skye Bioscience has no revenue, anticipates rising R&D and G&A expenses for nimacimab's development, and revised its legal contingency to $1.81 million after an appeal - The company has not generated any revenue and does not expect to until regulatory approval and commercialization of drug candidates or through collaborative agreements[63](index=63&type=chunk) - Research and development expenses are expected to increase due to the advancement of **nimacimab's clinical program** and future drug candidates[66](index=66&type=chunk) - General and administrative expenses are anticipated to rise due to increased headcount, infrastructure building, and public company compliance costs[67](index=67&type=chunk)[69](index=69&type=chunk) - The estimated legal contingency for the Cunning Lawsuit was reduced to **$1,806,065** as of June 30, 2025, following a successful appeal[70](index=70&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) Operating expenses and other income/expense are detailed, showing significant R&D increases for nimacimab, stable G&A, and changes in interest income/expense for the periods ended June 30, 2025 [For the three months ended June 30, 2025 and 2024](index=18&type=section&id=For%20the%20three%20months%20ended%20June%2030%2C%202025%20and%202024) R&D expenses surged 252% due to nimacimab's clinical and manufacturing costs, G&A decreased 10%, and other (income) expense increased 22% for the three months ended June 30, 2025 | Expense Category | 3 Months Ended June 30, 2025 ($) | 3 Months Ended June 30, 2024 ($) | $ Change ($) | % Change | | :-------------------------- | :--------------------------- | :--------------------------- | :------- | :------- | | Research and development | $14,337,753 | $4,078,751 | $10,259,002 | 252% | | General and administrative | $3,906,172 | $4,326,820 | $(420,648) | (10)% | | Total other (income) expense | $(622,453) | $(510,826) | $(111,627) | 22% | - R&D increase was primarily due to **$2.36 million** in clinical trial costs, **$6.62 million** in contract manufacturing for nimacimab, and **$0.72 million** in discovery R&D[74](index=74&type=chunk) - G&A decrease was mainly due to reduced legal and professional fees (**$854,783**) and general business expenses (**$371,633**), partially offset by increased salaries, stock-based compensation (**$563,161**), and consulting costs (**$142,092**)[79](index=79&type=chunk) - Other (income) expense change was influenced by a **$89,363 gain** from asset sales, a **$450,052 decrease** in interest expense, and a **$428,147 decrease** in interest and other income[76](index=76&type=chunk)[80](index=80&type=chunk) [For the six months ended June 30, 2025 and 2024](index=19&type=section&id=For%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) R&D expenses increased 257% due to nimacimab's clinical and manufacturing, G&A slightly decreased 1%, and other (income) expense decreased 22% for the six months ended June 30, 2025 | Expense Category | 6 Months Ended June 30, 2025 ($) | 6 Months Ended June 30, 2024 ($) | $ Change ($) | % Change | | :-------------------------- | :--------------------------- | :--------------------------- | :------- | :------- | | Research and development | $21,535,010 | $6,025,201 | $15,509,809 | 257% | | General and administrative | $8,468,477 | $8,532,620 | $(64,143) | (1)% | | Total other (income) expense | $(1,280,696) | $(1,645,545) | $364,849 | (22)% | - R&D increase was driven by **$3.63 million** in clinical trial costs, **$9.15 million** in contract manufacturing for nimacimab, **$1.34 million** in discovery R&D, and **$1.09 million** in personnel-related costs[83](index=83&type=chunk) - G&A decrease was mainly due to reduced legal and professional fees (**$862,862**) and general business expenses (**$358,592**), offset by increases in investor relations (**$565,089**), consulting (**$378,083**), and salaries (**$152,870**)[84](index=84&type=chunk) - Other (income) expense reduction was primarily due to an **$886,988 decrease** in interest expense and a **$1,055,645 decrease** in gain on asset sale (one-time event in prior year), partially offset by a **$197,458 decrease** in interest and other income[85](index=85&type=chunk)[91](index=91&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant operating losses and negative cash flows, with $159.7 million accumulated deficit and $23.8 million cash, but believes current funds are sufficient for 12 months, with future capital needs for Phase 2b | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :-------------- | :---------------- | | Working capital | $42,270,810 | N/A | | Accumulated deficit | $(159,677,863) | $(130,949,672) | | Stockholders' equity | $43,676,709 | $68,151,724 | | Unrestricted cash & short-term investments | $48,585,283 | $68,415,741 | - The company raised **$83,556,563** in net proceeds from PIPE financings in January and March 2024, intended to fund nimacimab's clinical trials through Phase 2a data and prepare for Phase 2b[87](index=87&type=chunk)[100](index=100&type=chunk) - In Q4 2024, the company recovered **$9 million** in restricted cash from a litigation bond and collected **$2 million** from an insurance carrier, reallocating funds to its clinical pipeline[90](index=90&type=chunk) - Management believes current cash will fund operations for at least **12 months** but anticipates needing additional funds for future development, especially for the Phase 2b study[92](index=92&type=chunk) [Off-Balance Sheet Arrangements](index=23&type=section&id=Off-Balance%20Sheet%20Arrangements) Skye Bioscience has no material off-balance sheet arrangements impacting its financial condition, results of operations, liquidity, or capital resources - There are no material off-balance sheet arrangements[101](index=101&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company has no material quantitative or qualitative disclosures regarding market risk, indicating it is not applicable for the reporting period - The company has no applicable quantitative and qualitative disclosures about market risk[102](index=102&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the fiscal quarter - Disclosure controls and procedures were **effective** at a reasonable assurance level as of June 30, 2025[104](index=104&type=chunk) - No material changes in internal control over financial reporting occurred during the fiscal quarter[105](index=105&type=chunk) [PART II - OTHER INFORMATION](index=24&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) Material legal proceedings, including the Wendy Cunning lawsuit remanded for a new trial, are detailed in Note 7 of the financial statements - Material legal proceedings are detailed in Note 7, 'General Litigation and Disputes,' of the financial statements[106](index=106&type=chunk) [Item 1A. Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the Annual Report on Form 10-K for December 31, 2024 - No material changes to risk factors since the Annual Report on Form 10-K for December 31, 2024[107](index=107&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the reporting period - No unregistered sales of equity securities and use of proceeds[108](index=108&type=chunk) [Item 3. Defaults Upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the reporting period - No defaults upon senior securities[109](index=109&type=chunk) [Item 4. Mine Safety Disclosures](index=24&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[110](index=110&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205.%20Other%20Information) Several officers and directors adopted Rule 10b5-1 trading plans in April 2025 for potential common stock sales, including RSU-related tax liability coverage - CFO Kaitlyn Arsenault adopted a Rule 10b5-1 trading plan on **April 24, 2025**, for potential sale of up to **45,434 shares** and an indeterminate number of shares to cover tax liability from RSUs until **December 31, 2027**[111](index=111&type=chunk) - Chairman Paul Grayson adopted a Rule 10b5-1 trading plan on **April 25, 2025**, for potential sale of up to **86,563 RSU-related shares** (including tax coverage) and up to **98,138 common shares** until **December 31, 2026**[112](index=112&type=chunk) - CSO Chris Twitty and COO Tu Diep also adopted Rule 10b5-1 trading plans on **April 25** and **April 29, 2025**, respectively, primarily to cover tax liabilities upon the vesting of their unvested restricted stock units until **December 31, 2026**[113](index=113&type=chunk)[114](index=114&type=chunk) [Item 6. Exhibits](index=25&type=section&id=Item%206.%20Exhibits) Exhibits filed with Form 10-Q include organizational documents, officer certifications, and XBRL-formatted financial statements - Exhibits include Amended and Restated Articles of Incorporation and Bylaws, certifications (**31.1, 31.2, 32.1, 32.2**), and Inline Extensible Business Reporting Language (iXBRL) formatted financial statements[116](index=116&type=chunk) [SIGNATURES](index=26&type=section&id=SIGNATURES) The report was signed by CEO Punit Dhillon and CFO Kaitlyn Arsenault on behalf of Skye Bioscience, Inc. on August 7, 2025 - The report was signed by Punit Dhillon, CEO, and Kaitlyn Arsenault, CFO, on **August 7, 2025**[121](index=121&type=chunk)