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SARASOTA, FL - Silo Pharma, Inc. (NASDAQ: SILO), a biopharmaceutical company currently trading at $0.49, down significantly from its 52-week high of $4.50, has announced a service agreement with Resyca BV to conduct a drug-device study for its PTSD treatment, SPC-15. The study aims to collect final device data for a planned FDA Investigational New Drug (IND) submission later this year. According to InvestingPro analysis, the company, while currently unprofitable, shows promising fundamentals with impressive gross profit margins above 90%.
SPC-15, an intranasal serotonin 5-HT4 receptor agonist, is designed to treat stress-induced psychiatric disorders, including PTSD and anxiety. The microchip-based nasal spray system delivers medication directly to the brain, potentially offering faster relief and improved safety for patients by bypassing the blood-brain barrier.
CEO Eric Weisblum expressed optimism about the device’s ability to "drive faster onset of therapeutic benefit with optimized safety." Silo Pharma is also conducting two additional studies on SPC-15, including a toxicology study and a large animal safety study requested by the FDA. With a current ratio of 4.73, InvestingPro data shows the company maintains strong liquidity to support its research initiatives. Discover 12 additional exclusive insights about SILO’s financial health with an InvestingPro subscription.
Resyca BV, established in 2020, is a joint venture that specializes in developing inhalation and nasal spray devices utilizing proprietary micro-nozzle technology. These devices are designed for user-friendliness and compatibility with standard pre-filled syringes.
SPC-15 could benefit from the FDA’s 505(b)(2) regulatory pathway, potentially expediting approval. Silo Pharma has exclusive global rights to SPC-15 and is in collaboration with Columbia University for preclinical studies.
Silo Pharma focuses on psychiatric disorders, chronic pain, and CNS diseases, with a portfolio that includes programs targeting Alzheimer’s disease and multiple sclerosis. The company works closely with universities and laboratories to advance its research.
This press release contains forward-looking statements regarding the potential of SPC-15 and its approval process. These statements are subject to various risks and uncertainties, including the possibility of unfavorable FDA decisions or delays. With a market capitalization of just $3.82 million and trading near its 52-week low, InvestingPro’s Fair Value analysis suggests the stock may be undervalued. The information reported is based on a press release statement and does not include any assumptions or predictions by the author.
In other recent news, Silo Pharma, Inc. has announced a public offering of securities, expected to generate approximately $2 million in gross proceeds. The offering, priced at $0.60 per unit, includes shares of common stock and warrants, with H.C. Wainwright & Co. serving as the exclusive placement agent. Silo Pharma has also advanced its PTSD treatment study, SPC-15, through a partnership with Veloxity Labs, aiming to submit an investigational new drug application to the FDA within the year. Additionally, the company has engaged Frontage Laboratories for a critical safety study on SPC-15, in response to an FDA request, which could support an IND submission in 2025.
Silo Pharma reported positive preclinical results for SP-26, its ketamine implant for fibromyalgia, which met all study endpoints, suggesting potential as a long-acting therapy. The company has also filed a patent application for SPC-14, a drug targeting Alzheimer’s disease, with early studies indicating potential improvements in cognitive memory function. These developments reflect Silo Pharma’s ongoing efforts in research and development across various therapeutic areas, including psychiatric disorders and chronic pain. The company remains committed to advancing its pipeline through strategic partnerships and collaborations with leading universities and laboratories.
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