SARASOTA, FL - Silo Pharma Inc. (NASDAQ:SILO), a biopharmaceutical company in the developmental stage, has announced promising outcomes from a preclinical study of its drug candidate SPC-15. The study suggests potential benefits for treating severe stress-related psychiatric disorders, including major depressive disorder (MDD) and post-traumatic stress disorder (PTSD).
SPC-15, an intranasal formulation, targets both the serotonin 5-HT4 receptor (5-HT4R) and the NMDA receptor (NMDAR). The preclinical study demonstrated that the dual-action approach might offer superior efficacy over treatments that target either receptor alone. According to the company's CEO, Eric Weisblum, the results underscore a potentially effective treatment option for patients with severe and relapsed stress-related disorders.
The company is moving forward with plans to submit an Investigational New Drug (IND) application for first-in-human trials, with the hope that SPC-15 may qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval. This pathway could potentially expedite the development process for SPC-15 if it proves to be clinically successful.
Silo Pharma's research into SPC-15 is in collaboration with Columbia University, and the company has secured an exclusive license to further develop, manufacture, and commercialize the drug worldwide. Silo Pharma focuses on addressing underserved conditions such as stress-induced psychiatric disorders, chronic pain, and central nervous system diseases by developing traditional and psychedelic treatments in novel formulations and drug delivery systems.
The company's portfolio also includes SP-26, a time-release ketamine-loaded implant for fibromyalgia and chronic pain, as well as preclinical programs SPC-14 and SPU-16, targeting Alzheimer's disease and multiple sclerosis, respectively.
The information in this article is based on a press release statement. Silo Pharma cautions that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected. The company does not undertake any obligation to update or revise any forward-looking statements.
In other recent news, Silo Pharma has made significant progress with its post-traumatic stress disorder (PTSD) treatment, SPC-15. The biopharmaceutical company has completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA), which may expedite the clinical process and reduce development costs for the drug. Silo Pharma is now preparing for an Investigational New Drug (IND) submission, a step toward first-in-human clinical trials.
The company's other recent developments include collaborations with Sever Pharma Solutions, WuXi AppTec, and Resyca BV to advance various treatments. Furthermore, Silo Pharma has secured an exclusive global license to develop its Alzheimer's medication, SPC-14, and the drug candidate SPC-15 for stress-related disorders and PTSD through a licensing deal with Columbia University.
On the financial front, Silo Pharma 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 latest developments in Silo Pharma's ongoing commitment to creating novel treatments for various health conditions.
InvestingPro Insights
As Silo Pharma (NASDAQ:SILO) advances its promising SPC-15 drug candidate, investors may find value in examining the company's financial health and market performance. According to InvestingPro data, Silo Pharma has a market capitalization of $5.07 million, reflecting its early-stage status in the biopharmaceutical industry.
One of the InvestingPro Tips highlights that Silo Pharma "holds more cash than debt on its balance sheet," which is crucial for a developmental stage company as it provides financial flexibility to fund ongoing research and clinical trials. This strong cash position aligns with the company's plans to submit an Investigational New Drug application for SPC-15 and potentially pursue the FDA's 505(b)(2) regulatory pathway.
Another relevant InvestingPro Tip notes that Silo Pharma has "impressive gross profit margins," with data showing a gross profit margin of 91.9% for the last twelve months as of Q3 2023. This high margin could be indicative of the potential value of the company's intellectual property and licensing agreements, such as the exclusive license for SPC-15.
It's worth noting that the stock has "taken a big hit over the last week," with a 1-week price total return of -14.39%. This volatility is not uncommon for early-stage biopharmaceutical companies, especially as they approach critical milestones in drug development.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights, with 7 more tips available for Silo Pharma on the platform.
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