SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a biopharmaceutical company specializing in novel therapies, has announced an exclusive licensing deal with Columbia University to develop and market its primary drug candidate, SPC-15, for stress-related disorders and PTSD. The agreement grants Silo the global rights to advance SPC-15, which is currently in the preclinical stage.
Silo Pharma has recently approached the U.S. Food and Drug Administration (FDA) for a pre-IND meeting regarding SPC-15, with plans to submit an Investigational New Drug (IND) application soon. The company aims to leverage the FDA's 505(b)(2) regulatory pathway for SPC-15, potentially expediting the clinical process and reducing development costs.
SPC-15, a serotonin receptor agonist, is being developed as an intranasal medication to treat PTSD, anxiety, and other stress-induced affective disorders. The drug's success in clinical trials could see it benefiting from the streamlined FDA approval process.
Eric Weisblum, CEO of Silo, expressed optimism about the exclusive licensing agreement's potential to enhance shareholder value, pending FDA approval. Silo's collaboration with Columbia University is part of its broader strategy to develop treatments for psychiatric disorders, chronic pain, and central nervous system diseases.
Aside from SPC-15, Silo's pipeline includes SP-26, a time-release ketamine implant for chronic pain and fibromyalgia, and preclinical compounds SPC-14 and SPU-16, targeting Alzheimer's disease and multiple sclerosis, respectively.
In other recent news, Silo Pharma has been making significant strides in various areas. The company has amended its Master License Agreement with the University of Maryland, indicating ongoing commitment to the agreement's terms.
It has also initiated a pivotal Good Laboratory Practice study for its SPC-15 intranasal therapeutic for post-traumatic stress disorder (PTSD), marking a significant step towards human clinical trials.
The company has announced a registered direct offering and concurrent private placement of securities, intending to raise approximately $2 million. These funds are projected to be used for working capital and general corporate purposes. Silo Pharma has also reported encouraging results from a study on a new drug formulation for depression treatment, potentially improving mood stability and extending remission periods for patients.
Silo Pharma has progressed in the development of its SP-26 ketamine implant for chronic pain, with pre-clinical research showing promising results. The company is currently advancing towards identifying the optimal formulation for future testing. Additionally, Silo Pharma has initiated steps towards clinical trials for its PTSD treatment, SPC-15, after submitting a pre-Investigational New Drug briefing package to the U.S. Food and Drug Administration.
InvestingPro Insights
Silo Pharma, Inc. (NASDAQ:SILO) has shown a commitment to advancing its primary drug candidate, SPC-15, with the recent exclusive licensing deal with Columbia University. The company's strategic initiatives are reflected in its financial metrics and management activities. Notably, Silo Pharma's management has been proactively engaging in share buybacks, a sign that they believe in the company's value proposition. This aligns with the InvestingPro Tip that highlights the company's aggressive share repurchase strategy.
On the financial front, Silo Pharma's balance sheet appears robust, with the company holding more cash than debt, which is critical for funding ongoing research and development without relying excessively on external financing. Another InvestingPro Tip points out that the company has impressive gross profit margins, standing at 91.9% for the last twelve months as of Q1 2024. This is a positive indicator of the company's ability to manage its cost of goods sold effectively and maintain profitability at the gross level.
However, investors should be aware of the challenges ahead. Analysts have expressed concerns about the company's profitability, anticipating that Silo Pharma may not achieve profitability this year. Additionally, the stock has experienced significant volatility, with a 53.27% decline over the last three months and currently trading near its 52-week low. This could present a buying opportunity for long-term investors who believe in the company's prospects, especially considering Silo Pharma's niche position in the biopharmaceutical industry.
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InvestingPro Data metrics for Silo Pharma include a modest market capitalization of 3.55 million USD, reflecting its small-cap status in the market. The company's price/book ratio as of the last twelve months stands at 0.67, which could suggest that the stock is undervalued relative to its assets, a factor that value investors often consider.
These insights provide a snapshot of Silo Pharma's financial health and market position, which are crucial considerations for investors as they weigh the potential risks and rewards associated with the company's stock.
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