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SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a developmental stage biopharmaceutical company with a current market capitalization of $5.7 million, announced Wednesday it has completed dosing in a 7-day safety and toxicology large animal study for its lead drug candidate SPC-15, a treatment being developed for post-traumatic stress disorder (PTSD). According to InvestingPro analysis, the company maintains a strong liquidity position with current assets exceeding short-term obligations by nearly 5 times.
The study was requested by the U.S. Food and Drug Administration, with bioanalytical and safety/toxicology results expected within 60 days, according to the company’s press release statement.
SPC-15 is an intranasal serotonin 5-HT4 receptor agonist designed to treat stress-induced psychiatric disorders including PTSD and anxiety.
"Our novel PTSD drug candidate SPC-15 has already shown strong safety and therapeutic delivery," said Eric Weisblum, CEO of Silo Pharma.
The developmental stage biopharmaceutical company is conducting two additional studies for SPC-15: an IND-enabling GLP-compliant toxicology and toxicokinetic animal study, and a device study of the drug’s microchip-based nasal spray delivery system.
Silo Pharma plans to seek FDA approval through the 505(b)(2) regulatory pathway, which can potentially reduce clinical timelines and development costs.
The company is collaborating with Columbia University on preclinical studies for SPC-15, for which it holds exclusive global development and commercialization rights.
Silo Pharma’s development portfolio also includes SP-26 for fibromyalgia and chronic pain, as well as preclinical assets targeting Alzheimer’s disease and multiple sclerosis.
In other recent news, Silo Pharma announced it expects to receive data from preclinical studies of its PTSD drug, SPC-15, within the next 30 to 90 days. This drug is undergoing final studies, including a toxicology study and a device study of its nasal spray system. The company also received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent related to SPC-15, which is expected to be issued in June 2025. Additionally, Silo Pharma has been notified by Nasdaq of non-compliance with the minimum bid price requirement, giving the company until December 2025 to regain compliance. In a strategic move, Silo’s Board of Directors approved the purchase of up to $1 million in Bitcoin as part of its treasury reserves. This decision aims to diversify the company’s assets and hedge against inflation. CEO Eric Weisblum emphasized the potential of Bitcoin to enhance long-term shareholder value. These developments reflect Silo Pharma’s ongoing efforts to advance its treatment portfolio and optimize its financial strategies.
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