
Executive Summary 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 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 diseases217 - The company is conducting a Phase 2a clinical trial for nimacimab, a peripherally restricted CB1 negative allosteric modulating antibody217 CEO Statement & Strategic Vision 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 20263 - 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 effects3 - 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 care3 Clinical & Research Development Highlights 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 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 202535 - 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 data56 - The independent Data Safety Monitoring Board has completed four unblinded reviews, finding no safety concerns, and the study continues as per protocol56 Preclinical Data & Nimacimab's Differentiated Profile 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 tirzepatide58 - 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 - 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 levels8 - 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 tirzepatide9 - 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 group9 - Using nimacimab alone after tirzepatide or combination therapy significantly reduced weight regain, reinforcing its potential as a weight maintenance therapy post-incretin treatment9 Corporate & Operational Updates 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 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 CMC10 - The company hired a Vice President of CMC to align with its advancement of clinical development and manufacturing readiness10 Manufacturing Updates 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 study15 - The company initiated a formulation development collaboration with Arecor Therapeutics plc to identify and develop higher concentration nimacimab formulations15 Investor Relations & Events 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 data7 - The company hosted a conference call on August 7, 2025, to discuss its Q2 2025 financial results15 Second Quarter 2025 Financial Results 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 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 activities11 Operating Results 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 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 expenses12 General and Administrative Expenses 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 costs13 Net Loss 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 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 receptors17 - The company's strategy is to leverage biologically validated human targets to develop clinically and commercially differentiated first-in-class therapies17 - 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 Forward-Looking Statements 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 partners18 - 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 anticipated18 - 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 competition1819 Financial Statements 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 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 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 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 - Media Inquiries contacts: mfitzhugh@lifescicomms.com, (628) 234-3889 (LifeSci Communications, Michael Fitzhugh)24