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SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a micro-cap biotech company with a market capitalization of $4.44 million and currently trading at $0.62 per share, announced Monday it expects to receive data from additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is an intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD). According to InvestingPro analysis, the company maintains impressive gross profit margins of 91.9%, though its stock has declined 30.83% year-to-date.
The company is currently conducting two final drug studies: an IND-enabling GLP-compliant toxicology study and an FDA-requested 7-day safety and toxicology large animal study. A separate device study of the microchip-based nasal spray system used in SPC-15 is also underway. InvestingPro data shows the company holds more cash than debt on its balance sheet, with a healthy current ratio of 4.73, potentially providing sufficient runway for these studies.
Pending positive results, Silo anticipates submitting an Investigational New Drug (IND) application before the end of 2025. If approved by the FDA within the standard 30-day review period, the company could begin Phase 1 clinical trials before the end of 2026.
"If submitted and approved, this will be a pivotal achievement along our path to first-in-human trials," said Eric Weisblum, CEO of Silo Pharma, in a press release statement.
The company plans to pursue the FDA’s 505(b)(2) regulatory pathway for SPC-15, which can potentially shorten clinical timelines and reduce development costs.
According to the company, only two drugs are currently FDA-approved for treating PTSD, primarily targeting depressive effects of the condition. In contrast, SPC-15 is designed to increase stress resilience in high-risk populations. No new PTSD drugs have been approved in nearly 25 years for a condition that affects an estimated 3.9% of the world’s population. While InvestingPro analysis indicates the company’s current Fair Value suggests potential upside, investors should note its WEAK overall Financial Health Score. Get access to 8 additional ProTips and comprehensive financial metrics by subscribing to InvestingPro.
SPC-15 is a 5-HT4 receptor agonist developed in collaboration with Columbia University, with Silo holding exclusive global rights to its development and commercialization.
In other recent news, Silo Pharma has made several noteworthy announcements. The company received a notification from The Nasdaq Stock Market regarding non-compliance with the minimum bid price requirement, which mandates a closing bid price of at least $1.00 per share. Silo Pharma has until December 24, 2025, to regain compliance, with the possibility of an additional 180-day period if necessary. In more positive developments, the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent related to Silo Pharma’s PTSD treatment technology, SPC-15. This patent, licensed from Columbia University, is expected to enhance the protection of their intranasal treatment targeting post-traumatic stress disorder.
Additionally, Silo Pharma’s Board of Directors has approved the purchase of up to $1 million in Bitcoin as part of its treasury reserves, aiming to diversify assets and hedge against inflation. This strategic move is seen as a way to potentially enhance long-term shareholder value. Furthermore, the company has entered into a service agreement with Resyca BV to conduct a drug-device study for SPC-15, in preparation for an FDA Investigational New Drug submission. These developments highlight Silo Pharma’s ongoing efforts to advance its portfolio in psychiatric disorders and explore innovative financial strategies.
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