Skye Bioscience Inc.(US:SKYE)2025-11-10 21:09Financial Performance - The company has not generated any revenue to date and does not expect to until regulatory approval and commercialization of nimacimab or future drug candidates[75]. - Operating losses for the nine months ended September 30, 2025, amounted to $43,268,021, compared to $19,526,617 for the same period in 2024[101]. - Net cash used in operating activities was $(33,296,042) for the nine months ended September 30, 2025, reflecting a net loss of $41,482,851[110]. - The company has incurred an accumulated deficit of $172,432,523 as of September 30, 2025[101]. - Total other income decreased by $560,625, a 52% decline, totaling $(509,874) for the three months ended September 30, 2025[91]. Research and Development - Skye Bioscience reported research and development expenses of $9,357,444 for Q3 2025, a 92% increase from $4,883,337 in Q3 2024[76][86]. - The company incurred $30,892,454 in research and development expenses for the nine months ended September 30, 2025, compared to $10,908,538 for the same period in 2024[76]. - Research and development expenses increased by $19,983,916, representing a 183% increase, totaling $30,892,454 for the nine months ended September 30, 2025[92]. - Clinical trial costs increased by $578,014 due to higher site and patient costs related to the Phase 2a study for nimacimab[86]. - Clinical trial costs increased by $4,203,355 due to higher site and patient costs related to the Phase 2a clinical study of nimacimab[94]. - Contract manufacturing costs rose by $2,704,671 due to drug substance and product costs for the extended Phase 2a clinical study[86]. - Contract manufacturing costs rose by $11,854,544, driven by expenses related to the Phase 2a clinical study of nimacimab[94]. - The Phase 2a clinical trial of nimacimab showed a weight loss of -13.2% in the combination arm with semaglutide, compared to -10.25% with semaglutide alone, with a p-value of 0.0372[71]. - In the combination arm, 100% of patients achieved over 5% weight loss, while 67% achieved over 10% weight loss, compared to 85% and 50% respectively with semaglutide alone[71]. - Skye expects to report data from the 26-week extension study of nimacimab in Q1 2026[72]. Expenses - General and administrative expenses decreased by $731,837 to $3,907,090 in Q3 2025, a 16% decline from $4,638,927 in Q3 2024[87]. - General and administrative expenses decreased by $795,980, a 6% decline, totaling $12,375,567 for the nine months ended September 30, 2025[95]. - The estimated legal contingency as of September 30, 2025, including accrued legal expenses, is $2,054,357[82]. - The company faces expenses related to attracting and retaining skilled personnel, public company costs, and potential litigation costs[116]. Financing Activities - The company raised $83,556,563 from private placement equity transactions in January and March 2024[102]. - During the nine months ended September 30, 2024, cash provided by financing activities included $83,556,563 from PIPE financings, net of issuance costs[115]. - There are no off-balance sheet arrangements that materially affect the company's financial condition or results of operations[117].