SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a developmental stage biopharmaceutical company, has announced progress in the development of its SP-26 ketamine implant, designed for the treatment of fibromyalgia and chronic pain. The company's pre-clinical research study has yielded promising results, moving it closer to identifying the optimal formulation for future testing.
The research involved analytical testing and small batch proof-of-concept extrusion trials for ketamine hydrochloride implants with both 20% and 40% drug loads. Initial tests validated the delivery system's structural stability and integrity. Subsequent manufacturing studies using three different bioresorbable polymers have shown positive data for inherent viscosity, blend uniformity, and dissolution rates of the implants. These results align with FDA guidelines for blend uniformity and dissolution times.
Eric Weisblum, CEO of Silo Pharma, expressed satisfaction with the observed structural stability, integrity, and functionality of the non-opioid chronic pain therapeutic thus far.
SP-26 is a ketamine-based injectable, dissolvable implant that is being developed to provide regulated dosage and timed release of pain-relieving treatment subcutaneously. Should SP-26 prove clinically successful, it may be eligible for the FDA's streamlined 505(b)(2) regulatory pathway, which could expedite the drug approval process.
Silo Pharma is also working on other novel therapeutics for various conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system diseases. Its lead program, SPC-15, targets PTSD and stress-induced anxiety disorders through an intranasal treatment. Additionally, Silo is developing SPC-14 and SPU-16, preclinical programs for Alzheimer’s disease and multiple sclerosis, respectively.
This announcement is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. These statements have not been evaluated by independent sources and reflect the company's expectations, which may not come to fruition. Silo Pharma cautions that these forward-looking statements are subject to changes in economic conditions, development challenges, and other factors that may impact the actual results.
In other recent news, Silo Pharma, a biopharmaceutical company, has made significant strides in its research and development efforts. The company announced a registered direct offering and concurrent private placement of securities, which are expected to raise approximately $2 million. The proceeds, before deducting fees and other expenses, are earmarked for working capital and general corporate purposes.
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. The company's research indicates the potential effectiveness of SPC-15 in treating PTSD and stress-induced anxiety disorder.
The company has also reported promising results from a study on a new drug formulation for depression treatment, potentially improving mood stability and extending remission periods for depression patients. In addition, Silo Pharma is set to participate in an FDA-sponsored public meeting to discuss the use of ketamine in emerging therapeutic areas.
Furthermore, the company is currently developing several drug candidates that feature ketamine as a primary therapeutic agent, including SP-26, a time-release ketamine-loaded implant for pain relief. These developments underscore Silo Pharma's commitment to exploring novel formulations and delivery systems for drugs that address conditions with limited treatment options.
InvestingPro Insights
In the wake of Silo Pharma's recent announcement concerning its SP-26 ketamine implant, investors and stakeholders are keen to understand the financial health and market performance of the company. Silo Pharma, currently holding a market capitalization of approximately $3.31 million, has demonstrated an impressive gross profit margin of 91.9% over the last twelve months as of Q1 2024, underscoring the company's ability to maintain high profitability relative to its revenue.
Notably, Silo Pharma's management has been actively engaging in share buybacks, a sign that the company's leadership is confident in its future prospects and committed to delivering value to its shareholders. This is further supported by the fact that Silo Pharma holds more cash than debt on its balance sheet, providing a strong liquidity position that can support ongoing research and development efforts.
However, it is important to note that analysts do not anticipate the company will be profitable this year. The stock price has experienced significant volatility, with a 43.27% drop over the last week and a 46.85% decrease over the past year, reflecting investor concerns and market fluctuations. These metrics suggest that while the company has solid fundamentals in some areas, it still faces challenges that could impact its financial performance.
For a deeper dive into Silo Pharma's metrics and additional InvestingPro Tips, such as the company's shareholder yield and its status as a niche player in the biopharmaceutical industry, investors can visit InvestingPro. There are 11 additional InvestingPro Tips available that could provide valuable insights into Silo Pharma's market strategy and future outlook. To access these tips and take advantage of real-time data and analysis, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.