Silo Pharma, Inc. - Common Stock (SILO)

Silo Pharma (NASDAQSILO), a developmental-stage biopharmaceutical company, has filed a provisional patent application with the U.S. Patent and Trademark Office (“USPTO”) for its lead asset SPC-15, demonstrating its commitment to innovative treatments for stress-induced psychiatric disorders, including post-traumatic stress disorder (“PTSD”). The patent focuses on targeting N-methyl-D-aspartate receptors (“NMDARs”) and serotonin type IV receptors (“5-HT4Rs”) to address stress-related behaviors such as perseverative behavior and hyponeophagia. Licensed through a collaboration with Columbia University, SPC-15 is exclusively owned and globally controlled by Silo for development and commercialization. CEO Eric Weisblum stated that the filing underscores Silo’s robust intellectual property (“IP”) strategy and enhances its ability to deliver transformative therapies. SPC-15, an intranasal serotonin 5-HT4 receptor agonist, also holds promise for the U.S. Food and Drug Administration’s (“FDA”) expedited 505(b)(2) approval pathway, facilitating accelerated development for PTSD and anxiety treatment.

SARASOTA, FL, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced the filing of a provisional patent application with the U.S. Patent and Trademark Office (USPTO). This application, focused on its lead asset SPC-15, highlights Silo’s commitment to advancing treatments for stress-induced psychiatric disorders, including post-traumatic stress disorder (PTSD).

Silo Pharma (NASDAQSILO) received a Notice of Allowance from the U.S. Patent and Trademark Office for a key patent supporting its lead asset, SPC-15, an intranasal treatment for PTSD. The patent, expected to be formally issued within 90 days, builds on Silo’s existing intellectual property and expands protection for SPC-15, a serotonin 5-HT4 receptor agonist designed for stress-induced disorders like PTSD and anxiety. Licensed exclusively from Columbia University, SPC-15 is in preclinical studies and may benefit from the FDA’s expedited 505(b)(2) regulatory pathway.

SARASOTA, FL, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for patent application 17/954,864 for “Pharmacological Prophylactics Against Stress-Induced Affective Disorders in Females.” Following receipt of the Notice of Allowance, Silo filed the final issue paperwork, paid the issue fees, and expects formal issuance of the patent in the next 90 days

SARASOTA, FL, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” “we,” “us,” “our,” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today issued a letter to shareholders highlighting the Company’s progress and potential for its lead assets SPC-15 and SP-26 as treatments for mental health and chronic pain management, respectively. The letter, in its entirety, is reprinted below.

Key preclinical milestone for novel, non-opioid extended-release pain therapeutic  

Silo Pharma (NASDAQSILO), a biopharmaceutical company developing innovative therapeutics, has initiated a pharmacokinetic (“PK”) and tolerability study for its dissolvable ketamine-based implant, SP-26, in collaboration with AmplifyBio. The study will evaluate SP-26, aimed at treating chronic pain and fibromyalgia, in a minipig model over three weeks, focusing on absorption, distribution, metabolism, and excretion (“ADME”). Silo CEO Eric Weisblum highlighted the progress made through earlier analytical and manufacturing tests, emphasizing this study as a key milestone. AmplifyBio expressed its commitment to supporting Silo in advancing SP-26’s safety evaluation.

Silo Pharma (NASDAQSILO) has entered into a collaboration with Kymanox to develop a subcutaneous insertion device for SP-26, its ketamine-loaded implant designed to treat fibromyalgia and chronic pain. The partnership will begin with proof-of-concept design, followed by prototype and feasibility testing to optimize insertion depth. Silo CEO Eric Weisblum highlighted the progress in developing SP-26, which aims to provide sustained pain relief and could potentially become the first FDA-approved at-home ketamine-based therapeutic. Kymanox also serves as Silo’s regulatory partner for SPC-15, a treatment targeting stress-induced affective disorders such as PTSD.

Prototype development and feasibility testing underway for optimized subcutaneous delivery

Silo Pharma (NASDAQSILO) announced encouraging preclinical study results for SPC-15, a novel dual-target therapy combining a serotonin 5-HT4 receptor agonist and an NMDA receptor antagonist. The treatment demonstrated superior efficacy in reducing stress-induced behaviors in animal models compared to single-agent therapies, highlighting its potential for managing major depressive disorder and other severe stress-related conditions. CEO Eric Weisblum emphasized the promising implications of SPC-15 as an intranasal prophylactic treatment for PTSD, with plans for an IND submission to initiate human trials. Developed in collaboration with Columbia University, SPC-15 may qualify for the FDA’s expedited 505(b)(2) approval pathway.

Dual-action approach combining 5-HT4R Agonist (SPC-15) and NMDAR antagonist demonstrates enhanced efficacy in preclinical study for managing severe conditions

Silo Pharma (NASDAQSILO), a biopharmaceutical company developing innovative treatments, announced promising results from recent tests on its SP-26 ketamine-loaded implant for fibromyalgia and chronic pain. Conducted with Sever Pharma Solutions, the sterilization and dissolution tests showed a sustained drug release of over 80% across seven days, demonstrating the implant’s consistent, time-controlled formulation. The tests also highlighted strong drug stability and reliable physical properties, key factors for safe and effective pain relief. Upcoming preclinical studies will assess the implant’s potential as a chronic pain treatment option.

The implant demonstrates stability and consistent drug release, supporting further analytical testing and development

Silo Pharma (NASDAQSILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, has completed a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”). The meeting focused on the company’s development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (“PTSD”) and stress-induced anxiety disorder. According to the announcement, the meeting was conducted through written responses provided by the FDA’s Division of Regulatory Operations for Neuroscience (“DRON”) — Psychiatry Group, which included submitting a proposal for FDA 505(b)(2) regulatory pathway for SPC-15 approval.

Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approval

Silo Pharma (NASDAQSILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, has entered a new agreement with Sever Pharma Solutions. According to the announcement, the agreement is regarding scale-up extrusion of Silo’s SP-26 dissolvable, ketamine-based, injectable implant designed for the treatment of fibromyalgia and chronic pain. The announcement also noted that Sever Pharma Solutions will continue performing the analytical testing of the ketamine hydrochloride (ketamine HCL) polymer implants using the optimal time-released, dose-controlled formulation previously selected by Silo for continuing preclinical studies.

SP-26 dissolvable ketamine-based injectable implant targets chronic pain and fibromyalgia

Silo Pharma (NASDAQSILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, has entered into an agreement with WuXi AppTec (Hong Kong) Limited, a leading global contract research organization (“CRO”). The agreement regards the launch of a preclinical small animal study of SPU-16, a central nervous system (“CNS”) homing peptide targeting multiple sclerosis (“MS”). According to the announcement, Silo Pharma is advancing SPU-16 development through a commercial evaluation license and option agreement with the University of Maryland, Baltimore (“UMB”).

Silo to advance homing peptide development for initial indication in multiple sclerosis

Silo Pharma (NASDAQSILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, will be presenting at the H.C. Wainwright 25th Annual Global Investment Conference. The conference is scheduled for Sept. 9–11, 2024, and will be held both virtually and in person in New York City. According to the announcement, virtual participation will be staged simultaneously with company presentations scheduled as live feed or available on-demand. Silo Pharma CEO Eric Weisblum will be presenting during the three-day event. Weisblum’s presentation will include an update on SPC-15, the company’s lead program, which is an intranasal prophylactic treatment for post-traumatic stress disorder (“PTSD”). Weisblum will also provide an overview of Silo Pharma’s novel IP-protected technologies and assets as well as additional investment highlights.

Presentation to feature Silo’s novel therapeutics for the underserved

SARASOTA, FL, July 22, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 763,638 shares of common stock at a purchase price of $2.75 per share. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 763,638 shares of common stock at an exercise price of $2.75 per share that are immediately exercisable upon issuance and will expire five years following the date of issuance.

Silo Pharma (NASDAQSILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, has entered into definitive agreements for the purchase and sale of 763,638 shares of common stock at a purchase price of $2.75 per unit in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, Silo Pharma will issue unregistered warrants to purchase up to 763,638 shares of common stock at an exercise price of $2.75 per unit. The warrants will be immediately exercisable upon issuance and will expire five years following the date of issuance. The offering is expected to close on or about July 22, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $2.1 million before deductions. Silo Pharma plans to use the net proceeds from the offering for working capital and general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

SARASOTA, FL, July 19, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that it has entered into definitive agreements for the purchase and sale of 763,638 shares of common stock at a purchase price of $2.75 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 763,638 shares of common stock at an exercise price of $2.75 per share that will be immediately exercisable upon issuance and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about July 22, 2024, subject to the satisfaction of customary closing conditions.

Silo Pharma (NASDAQSILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, has entered into a Device and CMC Development Master Plan with medical technology provider Resyca BV. A joint venture between Bespak Group and Medspray Pharma BV, Resyca manufactures the formulation-specific microchip-based spray system that Silo has chosen for its lead candidate SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (“PTSD”). According to the announcement, the Device and CMC Development Master Plan is intended to support the development, clinical formulation, and stability of a previously announced investigational new drug (“IND”)-enabling, large animal GLP (Good Laboratory Practice) study of SPC-15. “The patented nasal spray system uses cutting-edge nose-to-brain drug dispersion, a delivery method that transports the molecules to the brain directly, bypassing the blood-brain barrier,” said Eric Weisblum, CEO of Silo Pharma. “For SPC-15, we believe this delivery method could increase the drug’s concentration in the brain to deliver a faster onset of therapeutic benefit and optimized safety for PTSD patients.”