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Silo Pharma, Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company committed to merging traditional therapeutics with psychedelic research to address a variety of underserved conditions. The company's focus spans post-traumatic stress disorder (PTSD), fibromyalgia, Alzheimer's disease, Parkinson's disease, and other rare neurological disorders.
Silo's mission is to identify and license transformative assets, funding cutting-edge research to enhance patient well-being and advance the healthcare industry. Recent achievements include the filing of a provisional patent for SP-26, a ketamine-based implant for chronic pain management, and the exclusive licensing of SPC-15 from Columbia University, a novel intranasal treatment for PTSD and anxiety.
Core Business and Projects
- SPC-15: An intranasal treatment targeting PTSD and stress-induced anxiety disorders. Silo has exercised its option to license SPC-15 from Columbia University, with preclinical studies showing promising results.
- SP-26: A time-release, ketamine-loaded implant aimed at fibromyalgia and chronic pain relief. The implant has shown positive results in pre-clinical studies and is expected to be the first at-home approved ketamine-based therapeutic if it passes clinical trials.
- SPC-14: An intranasal compound for the treatment of Alzheimer's disease, showing potential in preclinical studies for improving cognitive function and stress reduction.
- SPU-16: A CNS-homing peptide targeting multiple sclerosis (MS), developed in collaboration with the University of Maryland, Baltimore.
Silo's innovative approach combines traditional therapies with psychedelic treatments, aiming to develop novel formulations and drug delivery systems. The company's robust pipeline and strategic partnerships with leading medical universities position Silo at the forefront of biopharmaceutical advancements.
Financial Condition and Partnerships
Silo Pharma collaborates extensively with Columbia University and the University of Maryland, Baltimore, providing essential financial resources to advance their research from the clinical stage to commercialization. The company is financially positioned to support ongoing and future projects that could significantly impact the medical and psychedelic treatment landscape.
For more information, visit www.silopharma.com and connect on social media at LinkedIn, X, and Facebook.
Silo Pharma (NASDAQ: SILO) announced positive preclinical study results for SPC-15, a novel dual-action treatment targeting stress-related disorders. The study combined SPC-15, a 5-HT4R agonist, with an NMDAR antagonist, demonstrating enhanced efficacy in treating stress-induced behaviors compared to single-agent treatments. The research showed significant improvements in behavioral outcomes related to severe stress-induced conditions in animal models. The company is developing SPC-15 as an intranasal prophylactic treatment for PTSD and plans to submit an IND for first-in-human trials.
Silo Pharma (SILO) announced positive results from sterilization and dissolution tests of its SP-26 ketamine-loaded implant for fibromyalgia and chronic pain. The tests, conducted under a development agreement with Sever Pharma Solutions, showed the implant achieved over 80% drug release over a 7-day period with consistent delivery. The implants demonstrated minimal variation in physical properties, indicating safety and stability. The company plans to proceed with animal studies to evaluate the efficacy of these dose-controlled, time-release implants for fibromyalgia and chronic pain treatment.
Silo Pharma (Nasdaq: SILO) has completed a pre-IND meeting with the FDA regarding SPC-15, an intranasal treatment for PTSD and stress-induced anxiety disorder. The company proposed a 505(b)(2) regulatory pathway for approval, which could shorten clinical timelines and reduce development costs. The FDA provided written responses, giving Silo a clear path to advance SPC-15 into human trials.
Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study before submitting an IND for a potential first-in-human clinical trial. Pre-clinical data suggests SPC-15 has additive benefits for combating stress-induced pathophysiology. Silo has an exclusive license from Columbia University to develop, manufacture, and commercialize SPC-15 worldwide.
Silo Pharma (NASDAQ: SILO) has expanded its development agreement with Sever Pharma Solutions for its novel ketamine-based injectable implant, SP-26, targeting chronic pain and fibromyalgia. The collaboration aims to scale-up extrusion processes and continue analytical testing for this non-opioid treatment. SP-26 is a dissolvable ketamine-loaded implant designed for time-released, dose-controlled delivery.
CEO Eric Weisblum expressed satisfaction with the ongoing partnership, highlighting that Sever Pharma has been instrumental in earlier production and delivery system validation. This expanded agreement is expected to bring Silo closer to selecting the optimal final dosage and formulation for animal studies. If clinically successful, SP-26 could potentially qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval, potentially expediting its market entry.
Silo Pharma (Nasdaq: SILO) has partnered with WuXi AppTec, a leading global CRO, for a preclinical study of SPU-16, a central nervous system (CNS) homing peptide targeting multiple sclerosis (MS). The study will examine the organ/tissue specificity of SPU-16 in an experimental autoimmune encephalomyelitis (EAE) protocol, the most common MS model.
SPU-16, developed under a license agreement with the University of Maryland, Baltimore, is designed to cross the blood-brain barrier and target damaged tissue and inflammation. It has shown potential to enhance therapeutic effects while reducing drug toxicity. The global MS drugs market is projected to grow from $21.2 billion in 2024 to $38.9 billion by 2032, with a 7.9% CAGR.
Silo Pharma (Nasdaq: SILO), a developmental stage biopharmaceutical company, has announced its participation in the H.C. Wainwright 25th Annual Global Investment Conference scheduled for September 9-11, 2024. CEO Eric Weisblum will present at the event, which will be held both in-person and virtually at the Lotte New York Palace Hotel.
The presentation will focus on Silo's lead program, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). Weisblum will provide updates on the program's progress, including the upcoming GLP study data and plans to submit an investigational new drug (IND) application to the FDA. Additionally, he will discuss Silo's novel IP-protected technologies, assets, and other investment highlights, showcasing the company's commitment to developing innovative therapeutics for underserved markets.
Silo Pharma (Nasdaq: SILO) has closed a $2.1 million registered direct offering priced at-the-market under Nasdaq rules. The offering included the sale of 763,638 shares of common stock at $2.75 per share. Additionally, in a concurrent private placement, the company issued unregistered warrants to purchase up to 763,638 shares at an exercise price of $2.75 per share, exercisable immediately and expiring in five years.
H.C. Wainwright & Co. acted as the exclusive placement agent. Silo Pharma intends to use the net proceeds for working capital and general corporate purposes. The common stock was offered under a shelf registration statement, while the warrants were offered in a private placement under Section 4(a)(2) of the Securities Act.
Silo Pharma (NASDAQ: SILO) has announced a $2.1 million registered direct offering priced at-the-market under Nasdaq rules. The company will sell 763,638 shares of common stock at $2.75 per share. Additionally, Silo will issue unregistered warrants to purchase up to 763,638 shares at an exercise price of $2.75 per share in a concurrent private placement. These warrants will be immediately exercisable and expire after five years.
The offering is expected to close around July 22, 2024. H.C. Wainwright & Co. is acting as the exclusive placement agent. Silo intends to use the net proceeds for working capital and general corporate purposes. The common stock is being offered under a shelf registration statement, while the warrants are offered in a private placement under Section 4(a)(2) of the Securities Act.
Silo Pharma (NASDAQ: SILO) has partnered with Resyca BV for the Device and CMC Development Master Plan of SPC-15, an intranasal PTSD treatment. This collaboration aims to support IND-enabling studies for SPC-15, which utilizes a patented nasal spray system for nose-to-brain drug delivery. The technology is expected to increase drug concentration in the brain, potentially offering faster therapeutic benefits and improved safety for PTSD patients.
Silo holds exclusive rights to Medspray's spray mist technology for multiple indications, including PTSD. The company is currently conducting GLP-compliant pharmacokinetic and pharmacodynamic studies and has submitted a pre-IND briefing package to the FDA. These steps are important for the eventual submission of an IND application, with the goal of initiating the first human clinical trial for SPC-15.
Silo Pharma (Nasdaq: SILO) has secured an exclusive global license for SPC-14, an Alzheimer's therapeutic. The company plans to use the FDA's 505(b)(2) pathway for expedited development. CEO Eric Weisblum believes SPC-14 could address a significant unmet medical need, with early pre-clinical studies showing stress reduction and cognitive improvement. This agreement follows a similar license for SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.
The global Alzheimer's disease therapeutics market is projected to exceed $30.8 billion by 2033, with a CAGR of 18.8% from 2024 to 2033. Market growth is expected to be driven by the increasing prevalence of Alzheimer's in the aging population and advancements in neurological research.
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