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SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a micro-cap pharmaceutical company with a market capitalization of $6.67 million and impressive gross profit margins of 91.9%, announced Tuesday that its lead asset SPC-15, an intranasal spray formulation for post-traumatic stress disorder (PTSD), has met safety standards in a FDA-requested 7-day large animal study.
The preclinical study compared the safety and exposure of SPC-15’s intranasal spray formulation to oral administration. Results showed that SPC-15, when administered at clinical-representative doses, demonstrated local and systemic safety with no toxicities identified. The study also indicated that systemic exposure of intranasal SPC-15 at the anticipated therapeutic range is comparable to standard oral administration. According to InvestingPro data, the company maintains a strong liquidity position with current assets exceeding short-term obligations by a ratio of 6.07.
"Overall, we believe the positive results of this study confirm that SPC-15’s formulation and spray profile meets the safety standards for clinical trials," said Silo CEO Eric Weisblum in the press release.
The company is currently conducting an IND-enabling GLP-compliant toxicology and toxicokinetic animal study of SPC-15, along with a device study of the formulation-specific microchip-based nasal spray system. Silo is also evaluating potential clinical CRO sites for first-in-human trials.
The company stated that the study data supports its planned 505(b)(2) regulatory strategy for the SPC-15 program, which could potentially streamline the FDA approval process by utilizing previously established safety and efficacy data from approved drugs.
According to the press release, the post-traumatic stress disorder market reached $1.8 billion in 2024 and is expected to grow to $3.2 billion by 2034. While SILO’s stock has seen volatility, trading at $0.71 with a 52-week range of $0.41-$3.37, InvestingPro analysis suggests the stock is currently undervalued. Subscribers can access 10+ additional ProTips and comprehensive financial metrics to better evaluate the company’s potential in this growing market.
In other recent news, Silo Pharma announced it has completed dosing in an FDA-requested safety and toxicology study for its PTSD drug candidate, SPC-15. The company expects bioanalytical and safety results from this study within 60 days. Additionally, Silo Pharma anticipates receiving data from further preclinical studies of SPC-15 in the next 30 to 90 days. The company is conducting two final drug studies, including an IND-enabling toxicology study and a device study for the microchip-based nasal spray system used with SPC-15. Moreover, Silo Pharma has received a Notice of Allowance for a patent related to SPC-15 from the U.S. Patent and Trademark Office. This patent, licensed from Columbia University, is expected to be issued in June 2025. In another development, Silo Pharma received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, although this does not immediately affect the listing or trading of its stock. Lastly, the company’s Board of Directors has approved the purchase of up to $1 million in Bitcoin as a treasury reserve asset, reflecting a strategic move to diversify holdings and hedge against inflation.
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