SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a biopharmaceutical company, has completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) concerning its SPC-15 development plan, the company announced today. SPC-15 is an intranasal medication intended as a prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder.
The pre-IND meeting, which took place through written correspondence with the FDA’s Division of Regulatory Operations for Neuroscience - Psychiatry Group, was aimed at discussing the 505(b)(2) regulatory pathway for the approval of SPC-15. This pathway could potentially expedite the clinical process and reduce development costs for the drug.
Silo's CEO, Eric Weisblum, stated that the FDA's written responses provided a clear direction for advancing SPC-15 into clinical trials. The company is currently conducting Good Laboratory Practice (GLP) compliant pharmacokinetic and pharmacodynamic studies in preparation for an Investigational New Drug (IND) submission, which is a step toward first-in-human clinical trials.
SPC-15, a serotonin 4 (5-HT4) receptor agonist, has shown in pre-clinical studies to offer benefits for treating stress-related conditions at both behavioral and neural levels. An exclusive license has been granted to Silo by Columbia University to develop, manufacture, and commercialize SPC-15 globally.
In addition to SPC-15, Silo Pharma is working on other preclinical programs, including SP-26, a time-release ketamine implant for pain relief, SPC-14 for Alzheimer’s disease treatment, and SPU-16 targeting multiple sclerosis.
The company focuses on developing new formulations and drug delivery systems for existing therapeutics and psychedelic treatments, aiming to address conditions such as psychiatric disorders, chronic pain, and central nervous system diseases.
This news is based on a press release statement and contains forward-looking statements regarding the company's future operations and potential revenue sources. These statements involve risks and uncertainties, and actual results may differ materially from those projected. Silo Pharma has provided no assurance that the expectations reflected in these forward-looking statements will prove correct.
In other recent news, Silo Pharma has been making significant strides in various sectors. The company has partnered with Sever Pharma Solutions to advance its SP-26 ketamine-based implant for chronic pain and fibromyalgia treatment. Concurrently, Silo Pharma has collaborated with WuXi AppTec for preclinical research on a peptide, SPU-16, aimed at treating multiple sclerosis. The company has also joined forces with Resyca BV to develop a microchip-based nasal spray system, potentially enhancing treatment for post-traumatic stress disorder.
Silo Pharma has secured an exclusive global license to develop its Alzheimer's medication, SPC-14. Additionally, the company has obtained exclusive rights to develop and market the drug candidate SPC-15 for stress-related disorders and PTSD through a licensing deal with Columbia University.
On the financial front, Silo Pharma has announced a registered direct offering and concurrent private placement of securities, securing approximately $2.1 million. These funds are anticipated to be used for working capital and general corporate purposes. These are the recent developments in the company's ongoing commitment to creating novel treatments for various health conditions.
InvestingPro Insights
Silo Pharma, Inc. (NASDAQ:SILO) has shown resilience in its financial health, holding more cash than debt on its balance sheet, which is a positive sign for investors looking at the company's ability to fund its drug development programs. This is particularly important for a biopharmaceutical company like Silo that is in the preclinical stage and has yet to bring a product to market. The company's impressive gross profit margins, which stand at 91.9% for the last twelve months as of Q2 2024, reflect its efficient cost management and potential for profitability once its products reach the market.
Despite not paying dividends, which is common for companies in the growth phase, Silo Pharma has experienced a significant return over the last week, with a price total return of 11.81%. This indicates a growing investor confidence in the company's future, potentially spurred by the recent advancements in their drug development pipeline, such as the progress with SPC-15. However, with a market capitalization of just 5.52 million USD and analysts not anticipating the company to be profitable this year, potential investors should be mindful of the risks associated with emerging biopharmaceutical companies.
For those interested in a deeper dive into Silo Pharma's potential, there are an additional 6 InvestingPro Tips available, which can provide more nuanced insights into the company's performance and outlook. These additional tips can be found at: https://www.investing.com/pro/SILO.
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