Skye Bioscience Inc.(SKYE) - 2025 Q1 - Quarterly Results

Skye Bioscience First Quarter 2025 Results and Corporate Highlights Clinical and Corporate Highlights 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] - Top-line data from the CBeyond™ Phase 2a study of nimacimab is expected in late Q3 or early Q4 2025[5] - 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] Research & Development Highlights 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] - In a preclinical study, nimacimab combined with the dual GLP-1/GIP agonist tirzepatide achieved over 30% weight loss[12] - As a monotherapy, nimacimab produced 23.5% weight loss, which was comparable to both monlunabant and tirzepatide alone in the same study[12] - 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][12] First Quarter 2025 Financial Results 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] 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 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 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 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 |