Silo Pharma, Inc. - SILO STOCK NEWS

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.

Silo Pharma has secured an exclusive, global license with Columbia University to develop SPC-15, an intranasal treatment for PTSD and stress-induced anxiety disorders. The agreement includes extensive issued and pending IP patent applications. Silo has submitted a pre-IND briefing package to the FDA and is preparing for an IND application to begin human clinical trials. The company plans to use the FDA's 505(b)(2) pathway to expedite development and reduce costs. CEO Eric Weisblum emphasizes that this agreement could potentially increase shareholder value, contingent on FDA approval.