SARASOTA, FL - Silo Pharma Inc. (NASDAQ:SILO), a biopharmaceutical company with a current market capitalization of approximately $4 million, is moving forward with its lead therapeutic candidates, SPC-15 and SP-26, targeting mental health and chronic pain management, respectively. According to InvestingPro analysis, the company maintains impressive gross profit margins of 92%. The company has completed a pre-IND meeting with the FDA for SPC-15, an intranasal treatment for PTSD and stress-induced anxiety disorders, and expects to submit an investigational new drug (IND) application in 2025. Following approval, a Phase 1 clinical trial will commence.
SPC-15 has also shown potential for treating eating disorders and anorexia, with pre-clinical data suggesting that combining SPC-15 with an NMDA receptor antagonist could enhance efficacy for major depressive disorder and other severe stress-related conditions. Silo Pharma has secured an exclusive global license from Columbia University for the development and commercialization of SPC-15.
In parallel, Silo Pharma is preparing for early 2025 animal studies for its SP-26 ketamine implants, designed to provide sustained relief for chronic pain and fibromyalgia, potentially offering an alternative to opioid treatments. SP-26 aims to become the first at-home injectable ketamine-based therapeutic if it meets FDA safety requirements and receives approval.
Both SPC-15 and SP-26 could benefit from the FDA’s 505(b)(2) regulatory pathway, which allows drug developers to leverage existing public data for new drug applications, potentially shortening clinical timelines and reducing costs.
The company's advancements come at a time when there is a significant unmet need for treatments for central nervous system diseases, with PTSD having seen no new drug approvals in nearly 25 years and limited options for fibromyalgia treatment. Silo Pharma is also developing treatments for Alzheimer’s disease and multiple sclerosis, tapping into markets with substantial growth projections.
With a strong balance sheet and minimal debt, evidenced by a healthy current ratio of 7.91 and more cash than debt on its books, Silo Pharma is positioned to continue its research and development efforts. InvestingPro analysis suggests the stock is currently undervalued, though investors should note that analysts don't expect profitability this year. The company's progress in 2024 is expected to lead to significant developments in 2025, with its next earnings report scheduled for February 26. Want deeper insights? InvestingPro subscribers have access to over 30 additional financial metrics and exclusive analysis tools.
This article is based on a press release statement from Silo Pharma.
In other recent news, Silo Pharma has seen noteworthy developments. The company reported promising outcomes from a preclinical study of its drug candidate SPC-15, which is being developed for severe stress-related psychiatric disorders, including major depressive disorder and post-traumatic stress disorder. Silo Pharma has also made significant strides in the development of its ketamine implant, SP-26, for chronic pain.
In addition to these developments, the company announced a registered direct offering and concurrent private placement of securities, securing approximately $2.1 million. This capital is expected to be used for working capital and general corporate purposes.
On the corporate governance front, the annual shareholder meeting saw the re-election of its board members and the ratification of its independent public accounting firm, Salberg & Company, P.A. Shareholders also approved the "Say on Pay" proposal, indicating their approval of executive compensation.
Furthermore, Silo Pharma is collaborating with Sever Pharma Solutions, WuXi AppTec, and Resyca BV to advance various treatments. The company has secured an exclusive global license to develop SPC-14 and SPC-15 through a licensing deal with Columbia University.
These are all recent developments, reflecting the ongoing commitment of Silo Pharma to creating novel treatments for various health conditions.
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