• This model demonstrates that central inhibition of CB1 is not required for weight loss Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next- generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT0 ...

Financial Data and Key Metrics Changes - Cash and cash equivalents and short-term investments totaled $59.2 million as of March 31, 2025 [18] - Research and development expenses increased to $7.2 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024 [19] - General and administrative expenses rose to $4.6 million for the three months ended March 31, 2025, compared to $4.2 million for the same period in 2024 [19] - The net loss for the three months ended March 31, 2025, was $11.1 million, with non-cash share-based compensation expense of $2.2 million [20] Business Line Data and Key Metrics Changes - The company completed enrollment in its Phase IIa CBEYOND trial ahead of schedule and amended the study to extend to 52 weeks [5][6] - Compelling new preclinical data was generated that validates the potential of nirmasumab as a weight loss therapy [6][7] - The Data Safety Monitoring Committee completed three reviews with no safety concerns reported [8] Market Data and Key Metrics Changes - The evolving policy environment presents regulatory uncertainties, particularly regarding drug pricing policy [9] - The company believes its exposure to these regulatory changes is limited in the near term as it prioritizes clinical development milestones [9] Company Strategy and Development Direction - The company aims to address the chronic nature of obesity with sustainable long-term solutions through its differentiated approach to weight loss therapies [10] - The management team emphasizes the importance of clear differentiation from small molecule inhibitors and the potential for nirmasumab to provide durable weight loss with fewer safety concerns [6][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for nirmasumab to deliver significant weight loss [10] - The company is closely monitoring regulatory developments and has preserved flexibility in its supply chain and capital deployment planning [9][22] Other Important Information - The company anticipates that its current capital will fund operations and key clinical milestones through at least Q1 2027 [19] - The final drug substance is manufactured in Germany, with no expected impact from tariffs on raw materials or excipients [20][21] Q&A Session Summary Question: What can we expect to see at ADA and ECO? - Management deferred to the CSO for details on the presentations at ADA and ECO, highlighting the importance of differentiating their mechanism from small molecules [25][27] Question: How do you view the difference between nirmasumab and monlunabant? - Management believes investors are beginning to grasp the differences, emphasizing the additive effects of nirmasumab in combination with tirzepatide [26][28] Question: What is the incremental benefit of extending the CBION study to 52 weeks? - The extension allows for broader efficacy and safety data collection, which will inform the Phase IIb study [66][68] Question: What are the expectations for separation from placebo in monotherapy? - The primary endpoint is targeting an 8% separation from placebo at 26 weeks [60] Question: How are you managing discontinuations in the combination arm? - The company has minimized gaps in treatment to avoid extended periods off semaglutide, ensuring patients remain on effective doses [100] Question: What are the plans for regulatory interactions? - The company has submitted a protocol amendment to the FDA and expects to resolve minor clarifications without needing a formal meeting [93][94]

Financial Data and Key Metrics Changes - Cash and cash equivalents and short-term investments totaled $59.2 million as of March 31, 2025 [17] - Research and development expenses increased to $7.2 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024 [18] - General and administrative expenses rose to $4.6 million for the three months ended March 31, 2025, compared to $4.2 million for the same period in 2024 [18] - The net loss for the three months ended March 31, 2025, was $11.1 million, with non-cash share-based compensation expense of $2.2 million [19] Business Line Data and Key Metrics Changes - The company completed enrollment in its Phase IIa CBEYOND trial ahead of schedule and amended the study to extend to 52 weeks [4][5] - New preclinical data validated the potential of nirmasumab as a weight loss therapy, showing significant weight loss comparable to less restricted small molecules [5][6] Market Data and Key Metrics Changes - The evolving policy environment presents regulatory uncertainties, particularly regarding drug pricing policy and FDA transitions [8][9] - The company believes its exposure to these uncertainties is limited in the near term as it prioritizes clinical development milestones [9] Company Strategy and Development Direction - The company aims to address the chronic nature of obesity with sustainable long-term solutions through its differentiated antibody approach [10] - The management is focused on disciplined execution while tracking developments in the regulatory landscape [9] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical progress and the potential of nirmasumab to deliver durable weight loss with fewer safety concerns [6][10] - The company is preparing for key scientific and investor events to present additional data [6] Other Important Information - The company is closely monitoring potential tariff impacts on its manufacturing activities, with no expected immediate effects [19][21] - The independent Data Safety Monitoring Committee has completed three reviews with no safety concerns reported [7][58] Q&A Session Summary Question: What can be expected at ADA and ECO? - Management deferred details about ADA and ECO presentations to the CSO, who mentioned a cohesive model comparing different CB1 inhibitors will be presented at ECO [24][30] Question: How does management view the differentiation between nirmasumab and monlunabant? - Management believes investors are beginning to grasp the differences, emphasizing the additive effects of nirmasumab in combination with tirzepatide [25][27] Question: What is the plan for regulatory interactions? - The company plans to have discussions with the FDA regarding the Phase IIa data and potential Phase IIb study after data readouts [35][39] Question: How does nirmasumab preserve lean muscle mass? - The combination of nirmasumab with tirzepatide shows significant fat mass reduction while preserving lean mass, with the greatest effect observed in combination [42][46] Question: What are the expectations for the primary endpoint at 26 weeks? - The primary endpoint is targeting an 8% weight loss at 26 weeks, with expectations for separation from placebo [61] Question: What is the incremental benefit of extending the CBION study to 52 weeks? - The extension allows for broader efficacy and safety data collection, which will inform the Phase IIb study [68][70] Question: How is the trial powered based on preclinical studies? - The preclinical data has increased confidence in the expected outcomes, with robust inhibition of CB1 and significant weight loss observed [78][80]

[Skye Bioscience First Quarter 2025 Results and Corporate Highlights](index=1&type=section&id=Skye%20Bioscience%20Reports%20First%20Quarter%202025%20Results) [Clinical and Corporate Highlights](index=1&type=section&id=Clinical%20and%20Corporate%20Highlights) Skye Bioscience advanced its lead candidate nimacimab for obesity, emphasizing its peripherally restricted mechanism, with Phase 2a trial data expected in late Q3 or early Q4 2025 - CEO Punit Dhillon emphasized that nimacimab's peripherally restricted mechanism may differentiate it from GLP-1s and small-molecule CB1 inhibitors, potentially reshaping the obesity treatment landscape[3](index=3&type=chunk) - Top-line data from the CBeyond™ Phase 2a study of nimacimab is expected in late Q3 or early Q4 2025[5](index=5&type=chunk) - The clinical trial is progressing well: the Data Safety Monitoring Committee has completed three reviews with no safety concerns, and the IRB has approved a 52-week open-label study extension[6](index=6&type=chunk) [Research & Development Highlights](index=2&type=section&id=Research%20%26%20Development%20Highlights) Preclinical data demonstrated nimacimab's efficacy in weight loss, both as monotherapy and in combination, highlighting its peripherally restricted mechanism to avoid neuropsychiatric side effects - Nimacimab's highly-peripherally restricted mechanism is sufficient to drive weight loss, avoiding brain exposure and potential neuropsychiatric side effects seen in less-restricted CB1 inhibitors like monlunabant[12](index=12&type=chunk) - In a preclinical study, nimacimab combined with the dual GLP-1/GIP agonist tirzepatide achieved over **30% weight loss**[12](index=12&type=chunk) - As a monotherapy, nimacimab produced **23.5% weight loss**, which was comparable to both monlunabant and tirzepatide alone in the same study[12](index=12&type=chunk) - In vitro data highlighted nimacimab's superior potency compared to the small molecule CB1 inhibitor monlunabant, especially under elevated concentrations of CB1 agonist associated with obesity[5](index=5&type=chunk)[12](index=12&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Skye Bioscience reported a net loss of **$11.1 million** for Q1 2025, with **$59.2 million** in cash expected to fund operations through Q1 2027, driven by increased operating expenses for the nimacimab Phase 2a study - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled **$59.2 million** This capital is expected to fund operations through at least Q1 2027, covering the completion of the extended Phase 2a study for nimacimab[8](index=8&type=chunk) Q1 2025 vs. Q1 2024 Operating Results | Financial Metric | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $7.2 million | $1.9 million | Increased contract manufacturing and clinical trial costs for nimacimab | | **G&A Expenses** | $4.6 million | $4.2 million | Increased investor relations, marketing, and consulting fees | | **Net Loss** | $11.1 million | $5.0 million | Higher operating expenses, particularly in R&D | [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) This section presents the unaudited consolidated financial statements for Skye Bioscience, including Statements of Operations for Q1 2025 and Balance Sheets as of March 31, 2025 [Consolidated Statements of Operations](index=4&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Total operating expenses for Q1 2025 increased to **$11.8 million** from **$6.2 million** year-over-year, resulting in a net loss of **$11.1 million** or **$0.28 per share** Consolidated Statements of Operations (Unaudited, USD) | | Three Months Ended March 31, | | :--- | :---: | :---: | | | **2025** | **2024** | | **Operating expenses** | | | | Research and development | $7,197,257 | $1,946,450 | | General and administrative | $4,562,305 | $4,205,800 | | **Total operating expenses** | **$11,759,562** | **$6,152,250** | | **Operating loss** | **($11,759,562)** | **($6,152,250)** | | **Net loss** | **($11,103,319)** | **($5,019,531)** | | **Loss per common share (Basic & Diluted)** | **($0.28)** | **($0.18)** | | **Weighted average shares outstanding (Basic & Diluted)** | 39,651,888 | 27,999,901 | [Consolidated Balance Sheets](index=5&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, total assets were **$64.8 million**, a decrease from **$72.8 million** at year-end 2024, primarily due to cash used in operations, while total liabilities increased to **$5.5 million** Consolidated Balance Sheet Highlights (Unaudited, USD) | | **March 31, 2025** | **December 31, 2024** | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $46,421,299 | $68,415,741 | | Total current assets | $63,027,781 | $70,827,247 | | **Total assets** | **$64,793,240** | **$72,763,773** | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $5,319,460 | $4,338,887 | | **Total liabilities** | **$5,542,926** | **$4,612,049** | | **Total stockholders' equity** | **$59,250,314** | **$68,151,724** | | **Total liabilities and stockholders' equity** | **$64,793,240** | **$72,763,773** |

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Skye Bioscience, a clinical-stage biotech, reported an increased net loss in Q1 2025 driven by higher R&D, with total assets decreasing due to cash usage - The company is a clinical-stage biotechnology firm focused on developing molecules to treat obesity and related conditions, and has not yet generated revenue from its principal operations[19](index=19&type=chunk)[20](index=20&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$64.8 million** as of March 31, 2025, from **$72.8 million** at year-end 2024, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $46,421 | $68,416 | | Short-term investments | $12,803 | $0 | | Total current assets | $63,028 | $70,827 | | Total assets | $64,793 | $72,764 | | **Liabilities & Equity** | | | | Total current liabilities | $5,319 | $4,339 | | Total liabilities | $5,543 | $4,612 | | Total stockholders' equity | $59,250 | $68,152 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of **$11.1 million** in Q1 2025, up from **$5.0 million** in Q1 2024, primarily due to increased research and development expenses Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $7,197 | $1,946 | | General and administrative | $4,562 | $4,206 | | **Operating loss** | **($11,760)** | **($6,152)** | | Total other (income) expense, net | ($658) | ($1,135) | | **Net loss** | **($11,103)** | **($5,020)** | | **Loss per share (basic & diluted)** | **($0.28)** | **($0.18)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$9.2 million** in Q1 2025, with total cash and equivalents decreasing by **$22.0 million** due to investing activities and no financing Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,185) | $(4,708) | | Net cash (used in) provided by investing activities | $(12,809) | $1,142 | | Net cash provided by financing activities | $0 | $85,653 | | **Net (decrease) increase in cash** | **$(21,994)** | **$82,086** | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key disclosures include the 'Wendy Cunning vs Skye Bioscience, Inc.' lawsuit with a **$1.9 million** contingency, disaggregated R&D expenses highlighting nimacimab, and details on stock incentive plans - The company is party to the 'Wendy Cunning vs Skye Bioscience, Inc.' lawsuit, where a previous judgment was vacated, a new trial is scheduled for September 2025, and the estimated legal contingency is **$1,913,003** as of March 31, 2025[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) Disaggregated Research and Development Expenses (Q1 2025 vs Q1 2024, in thousands) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | nimacimab | $5,184,865 | $129,120 | | Personnel related and stock-based compensation | $1,337,958 | $811,789 | | Other research and development expenses | $669,026 | $144,847 | | SBI-100 | $5,408 | $860,694 | | **Total R&D Expenses** | **$7,197,257** | **$1,946,450** | - As of March 31, 2025, the company had **1,170,197 shares** available for future grant under its Amended and Restated Omnibus Incentive Plan and **230,500 shares** available under its 2024 Inducement Equity Incentive Plan[34](index=34&type=chunk)[35](index=35&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the nimacimab Phase 2a trial, the **270% increase** in R&D expenses to **$7.2 million**, and confirms **$59.2 million** in liquidity is sufficient for the next 12 months - The company's lead candidate, nimacimab, is in a Phase 2a clinical trial for obesity, with top-line data expected in late Q3 or early Q4 2025, and the trial has been extended to 52 weeks to gather longer-term data[57](index=57&type=chunk)[58](index=58&type=chunk) - The company believes its current cash will be sufficient to fund projected operations for at least 12 months from the issuance date of the financial statements[85](index=85&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) R&D expenses surged by **270%** to **$7.2 million** in Q1 2025 due to nimacimab, while G&A expenses increased by **8%**, and other income decreased due to non-recurring gains Change in Research & Development Expenses (Q1 2025 vs Q1 2024, in thousands) | Expense Category | Change | Reason | | :--- | :--- | :--- | | Clinical trial costs | +$1,266,302 | Increased site and patient costs for Nimacimab Phase 2a study | | Contract manufacturing costs | +$2,532,130 | Drug substance and product costs for nimacimab | | Discovery research and development | +$623,020 | Increased work on nimacimab's mechanism of action | - General and administrative expenses increased by **$356,505 (8%)** YoY, primarily due to a **$373,571** increase in investor relations, marketing, and communications expenses[75](index=75&type=chunk)[79](index=79&type=chunk) - Total other income decreased by **$476,476** YoY, mainly because a **$1,145,141** gain on an asset sale in Q1 2024 did not recur, partially offset by a **$435,484** reduction in interest expense and a **$191,500** increase in interest income in Q1 2025[76](index=76&type=chunk)[77](index=77&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$59.2 million** in cash and equivalents as of March 31, 2025, asserting sufficient liquidity for at least 12 months, bolstered by **$83.6 million** from 2024 PIPE financings - The company had unrestricted cash, cash equivalents, and short-term investments of **$59.2 million** as of March 31, 2025, compared to **$68.4 million** as of December 31, 2024[80](index=80&type=chunk) - In January and March 2024, the company raised combined net proceeds of **$83.6 million** from two private placement (PIPE) financings[81](index=81&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,185) | $(4,708) | | Net cash (used in) provided by investing activities | $(12,809) | $1,142 | | Net cash provided by financing activities | $0 | $85,653 | [Quantitative and Qualitative Disclosures about Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is stated as 'Not applicable,' typical for a smaller reporting company with limited market risk exposure - The report states this item is '**Not applicable**'[96](index=96&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[98](index=98&type=chunk) - **No changes** in internal control over financial reporting occurred during the fiscal quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control[99](index=99&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 7 of the financial statements for details on material legal proceedings, primarily the 'Wendy Cunning vs Skye Bioscience, Inc.' lawsuit - For a description of material legal proceedings, the report refers to Note 7, 'General Litigation and Disputes' in the financial statements[101](index=101&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors from the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, have been reported - There have been **no material changes** to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024[102](index=102&type=chunk) [Other Information](index=23&type=section&id=Item%205.%20Other%20Information) Director Deborah Charych and CEO Punit Dhillon adopted Rule 10b5-1 trading plans in February and March 2025, respectively, for potential future stock sales - On February 12, 2025, Director Deborah Charych adopted a Rule 10b5-1 trading plan for the potential sale of up to **58,917 shares**[106](index=106&type=chunk) - On March 28, 2025, CEO Punit Dhillon adopted a Rule 10b5-1 trading plan covering the potential sale of shares from RSUs and his personal holdings through 2025 and 2026[107](index=107&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including CEO and CFO certifications and financial statements in Inline XBRL format - The exhibits filed with the report include certifications from the Principal Executive Officer and Principal Financial Officer (pursuant to Rules 13a-14, 15d-14, and Section 906 of Sarbanes-Oxley) and iXBRL data files[108](index=108&type=chunk)

Core Insights - Skye Bioscience, Inc. is making significant progress in its clinical operations and R&D, particularly with its lead candidate nimacimab for obesity treatment [2][3] - The company reported a net loss of $11.1 million for Q1 2025, an increase from $5.0 million in Q1 2024, primarily due to higher R&D expenses [10][8] - Skye's cash and cash equivalents totaled $59.2 million as of March 31, 2025, which is expected to fund operations through at least Q1 2027 [5] Clinical Highlights - The CBeyond™ Phase 2a trial for nimacimab is ongoing, with top-line data expected in late Q3 or early Q4 2025 [6][7] - Nimacimab has shown promising results in preclinical studies, demonstrating over 30% weight loss when combined with tirzepatide and 23.5% weight loss as a monotherapy [7] - The Data Safety Monitoring Committee has completed three safety reviews with no concerns, and the study protocol is being finalized with the FDA for a 52-week open-label study extension [7] Financial Results - R&D expenses for Q1 2025 were $7.2 million, up from $1.9 million in Q1 2024, driven by costs related to the Phase 2a clinical study [8] - General and administrative expenses increased to $4.6 million in Q1 2025 from $4.2 million in Q1 2024, mainly due to investor relations and marketing costs [9] - The total operating expenses for Q1 2025 were $11.8 million, compared to $6.2 million in the same period last year [16] Balance Sheet Highlights - As of March 31, 2025, total assets were $64.8 million, down from $72.8 million at the end of 2024 [19] - Current liabilities increased to $5.3 million from $4.3 million at the end of 2024, reflecting higher accounts payable and accrued liabilities [19] - Stockholders' equity decreased to $59.3 million from $68.2 million at the end of 2024, primarily due to the net loss incurred [19]

Summary of Sky Bioscience Conference Call Company Overview - **Company**: Sky Bioscience - **Focus**: Development of treatments for metabolic diseases, specifically obesity, utilizing a CB1 inhibitor named Nimasumab [3][4] Core Industry Insights - **Obesity Treatment Landscape**: The obesity treatment market is currently dominated by incretin-based therapies, which focus on caloric restriction. Sky Bioscience aims to differentiate itself by targeting a validated mechanism that addresses unmet needs for patients who discontinue incretin therapies [3][12][14]. - **Mechanism of Action**: Nimasumab operates independently of the GLP-1 pathway, focusing on peripheral fat metabolism rather than central nervous system effects, which have historically led to adverse neuropsychiatric events in previous CB1 inhibitors [8][9][10]. Key Points and Arguments - **Differentiation from Previous CB1 Inhibitors**: Previous CB1 inhibitors faced safety concerns leading to withdrawal from the market. Nimasumab is designed to minimize central nervous system engagement, showing a 600-fold reduction in brain activity compared to earlier drugs [8][9]. - **Clinical Development Strategy**: The company is focused on a disciplined capital allocation strategy, with approximately two years of cash runway, allowing for methodical progress in clinical trials without aggressive spending [5][38]. - **Phase 2 Trial Design**: The CBEYOND trial is a four-arm, double-blind, placebo-controlled study comparing Nimasumab to placebo and in combination with GLP-1 therapy (Wegovy). The trial aims to provide comprehensive data on weight loss and safety [25][26][27]. - **Weight Loss Expectations**: The company aims for a significant weight loss of over 5% at 26 weeks, which is considered competitive in the current market landscape [30][31]. Important but Overlooked Aspects - **Chronic Treatment Paradigm**: There is a shift in understanding that obesity treatments should be viewed as chronic therapies rather than short-term solutions. Many patients discontinue current therapies due to various reasons, including side effects and lack of efficacy [12][13]. - **Market Reaction to Competitors**: The recent market reaction to Novo's data highlights the importance of clear communication regarding expectations and outcomes. Sky Bioscience aims to avoid similar pitfalls by maintaining transparency in their clinical data and safety profiles [35][36][37]. - **Real-World Data Insights**: The company has conducted interviews with obesity doctors to gather real-world data, which suggests that their treatment may outperform existing therapies in practical applications [34]. Financial Position - **Cash Runway**: Sky Bioscience expects to maintain its cash runway until Q1 2027, allowing for continued investment in Nimasumab's development without significant interruptions [38]. This summary encapsulates the key insights and strategic direction of Sky Bioscience as discussed in the conference call, highlighting its innovative approach to obesity treatment and the importance of addressing safety and efficacy in its clinical trials.

Core Viewpoint - Skye Bioscience, Inc. is set to discuss its Q1 2025 financial results in a conference call on May 8, 2025, highlighting its focus on therapeutic pathways for obesity and metabolic health disorders [1][2]. Company Overview - Skye Bioscience is a clinical-stage biotechnology company dedicated to developing next-generation molecules that target G-protein coupled receptors for metabolic health [3]. - The company is conducting a Phase 2 clinical trial for nimacimab, an antibody that inhibits CB1, and is also evaluating its combination with a GLP-1R agonist (Wegovy®) [3]. Upcoming Events - A conference call will take place on May 8, 2025, at 1:30 p.m. PT/4:30 p.m. ET to discuss the company's financial results, with an earnings press release to be issued after market close on the same day [1][2].

Core Insights - Skye Bioscience, Inc. is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][2] - The company will participate in several upcoming healthcare conferences, including the European Congress on Obesity and the Citizens Life Sciences Conference [1][4] Company Overview - Skye is dedicated to developing next-generation molecules that modulate G-protein coupled receptors, aiming for first-in-class therapeutics with clinical and commercial differentiation [2] - 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®) [2] Upcoming Events - Skye will present a poster at the European Congress on Obesity in Malaga, Spain on May 13 [1] - The company will also have a presentation at the Citizens Life Sciences Conference in New York on May 8 and will hold one-on-one meetings at the Craig-Hallum Institutional Investor Conference in Minneapolis on May 28 [4]

Group 1 - Weight loss drug companies have experienced a decline from their peak hype approximately one year ago, with Novo Nordisk A/S, the manufacturer of Ozempic and Wegovy, seeing its stock price cut by more than half [1] Group 2 - The article highlights the author's background as a private investor based in Toronto, Canada, with a focus on capital markets and Canadian small cap stocks [1]