Silo Pharma(US:SILO)2025-11-13 21:18Drug Development and Research - The company is developing novel therapeutics targeting PTSD, stress-induced anxiety disorders, fibromyalgia, and CNS diseases, with a lead program, SPC-15, focusing on PTSD and anxiety [180]. - SPC-15 is designed as an intranasal drug and is expected to qualify for the FDA's streamlined 505(b)(2) regulatory pathway, with a pre-IND submission planned for 2026 [189][191]. - SP-26, a ketamine-based implant for fibromyalgia, is in preclinical research, with initial animal studies evaluating dosage and time release [193][195]. - The global Alzheimer's therapeutics market is projected to exceed $30.8 billion by 2033, presenting a significant opportunity for SPC-14, which targets cognitive symptoms in Alzheimer's disease [196]. - The company has entered into a license agreement with the University of Maryland for a ketamine polymer implant and a sponsored research agreement with Columbia University for Alzheimer's treatment [185][196]. - SPU-16 targets CNS disorders, with an initial indication for multiple sclerosis, and has been granted an exclusive option for a new commercial license [198][202]. - The company is actively pursuing the acquisition and development of intellectual property to treat rare diseases, expanding its business focus [186]. Financial Performance - Revenues for the three months ended September 30, 2025, and 2024 were both $18,025, while for the nine months, revenues remained at $54,076 for both years [210]. - Cost of revenues for the three months ended September 30, 2025, was $20,687, a significant increase from $1,459 in 2024; for the nine months, it rose to $23,606 from $4,378 [211]. - Total operating expenses for the three months ended September 30, 2025, were $1,148,804, up from $1,026,621 in 2024, and for the nine months, they increased to $3,524,608 from $2,942,040 [212]. - Research and development expenses for the three months ended September 30, 2025, were $543,615, a 5.0% increase from $517,548 in 2024; for the nine months, expenses surged to $1,854,824 from $1,292,437, marking a 43.5% increase [216]. - Loss from operations for the three months ended September 30, 2025, was $1,151,466, compared to $1,010,055 in 2024, reflecting a 14.0% increase; for the nine months, the loss increased to $3,494,138 from $2,892,342, a 20.8% rise [223]. - Net loss for the three months ended September 30, 2025, was $1,110,438, or $0.12 per share, compared to a net loss of $928,814, or $0.22 per share, in 2024, an increase of 19.6%; for the nine months, net loss was $3,346,168, or $0.50 per share, up from $2,662,260, or $0.78 per share, a 25.7% increase [226]. Cash Flow and Investments - As of September 30, 2025, working capital was $5,456,030, with $1,948,579 in short-term investments and $3,917,627 in cash and cash equivalents, compared to $5,455,483 in working capital at the end of 2024 [228]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $3,881,061, an increase of 33.1% from $2,916,482 in 2024 [232]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $1,164,009, a 15.1% increase from $1,011,436 in 2024 [233]. - On September 29, 2025, the company received net proceeds of $2,146,000 from the October 2025 Offering, which helps mitigate concerns about its ability to continue as a going concern [237]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $3,346,168, reflecting a net loss adjusted for non-cash items and changes in operating assets and liabilities [238]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $1,164,009, consisting of proceeds from the sale of short-term investments of $1,315,653 [238]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $2,728,880, which included net proceeds from the sale of common stock and pre-funded warrants of $1,593,897 [238]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $2,662,260, adjusted for non-cash items and changes in operating assets and liabilities [238]. - Net cash provided by investing activities for the nine months ended September 30, 2024, was $1,001,436, with proceeds from the sale of short-term investments of $1,149,320 [238]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $3,241,628, including net proceeds from the sale of common stock and pre-funded warrants of $1,673,216 [238]. Accounting and Compliance - Stock-based compensation is recognized based on the grant-date fair value of the award, in accordance with ASC 718 [241]. - Research and development costs are expensed when incurred, with significant estimates related to the percentage of completion of certain projects [242]. - The company does not expect the adoption of new accounting guidance to have a material impact on its consolidated financial statements [243]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures [245]. Digital Assets and Treasury Management - The company holds approximately $400,000 in digital assets as part of its cryptocurrency treasury strategy initiated in August 2025 [204]. - The gross proceeds from the October 2025 Offering were $2,500,000, with net proceeds of $2,146,000 after deducting fees and expenses [207]. - The company has engaged Fireblocks for its institutional crypto treasury platform, enhancing its digital asset management capabilities [206].