Silo Pharma Issues Letter to Shareholders Detailing Development Progress and Potential for Lead Assets Targeting PTSD and Chronic Pain

Core Insights - Silo Pharma is progressing towards first-in-human trials for its lead candidate SPC-15, an intranasal treatment targeting PTSD and stress-induced anxiety disorders, with an IND submission expected in 2025 [2][5] - The company is also advancing its SP-26 ketamine implants aimed at chronic pain management, with animal studies set to begin in early 2025 [3][8] - Silo Pharma's innovative therapies are supported by collaborations with leading medical research partners, enhancing its intellectual property and market entry advantages [3] SPC-15 Development - SPC-15 is designed as a serotonin 5-HT4 receptor agonist for treating PTSD and anxiety, with a pre-IND meeting with the FDA completed in September 2024 [5][17] - The drug may also be explored for treating eating disorders and major depressive disorder based on promising pre-clinical data [6] - An exclusive global license for SPC-15 development has been granted to Silo by Columbia University [7] SP-26 Development - SP-26 is a ketamine-based implant targeting fibromyalgia and chronic pain, with a focus on providing a non-addictive alternative to opioids [8][18] - The implant's design aims to ensure safety and efficacy, with the potential to become the first at-home injectable ketamine therapeutic if approved [9] Regulatory Pathways - Both SPC-15 and SP-26 may qualify for the FDA's streamlined 505(b)(2) regulatory pathway, which could expedite their approval processes [10][11] - This pathway allows the use of existing data on active ingredients, potentially reducing clinical development costs and timelines [10] Market Trends - There is a significant unmet need for treatments targeting PTSD, with no new drug approvals in nearly 25 years for a condition affecting approximately 3.9% of the global population [12][13] - The Alzheimer’s disease treatment market is projected to grow to $30.8 billion by 2033, while the market for multiple sclerosis drugs is expected to reach$38.9 billion by 2032 [14] Financial Position - The company reports a strong balance sheet with cash on hand and minimal debt, providing financial flexibility for ongoing research and development [15]