Preclinical Data to Support Advancement Toward First-in-Human Clinical Trials SARASOTA, FL, March 26, 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 first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for p ...

Core Insights - Silo Pharma, Inc. announced the issuance of a patent for pharmacological prophylactics against stress-induced affective disorders in females, with the patent number projected to be 12,239,614, effective March 4, 2025 [1][2][3] Patent and Product Development - The new patent reinforces protection for Silo's lead asset, SPC-15, which is an intranasal treatment targeting post-traumatic stress disorder (PTSD) and includes newly added claims to an existing patent [2][3] - SPC-15 is a serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders, with potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway, which could accelerate the approval process [4] Strategic Collaborations - Silo Pharma is collaborating with Columbia University to conduct preclinical studies for SPC-15, and the company holds exclusive global rights for its development and commercialization [4][5] - The CEO emphasized that strategic IP and patent expansion is crucial for advancing SPC-15 to clinical trials and enhancing the overall value of the company's pipeline [3]

Core Viewpoint - Silo Pharma has filed a provisional patent application for its lead asset SPC-15, which shows enhanced efficacy in treating stress-induced psychiatric disorders, particularly PTSD and anxiety [1][6]. Company Overview - Silo Pharma, Inc. is a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, addressing underserved conditions such as stress-induced psychiatric disorders, chronic pain, and CNS diseases [7]. Patent and Technology - The provisional patent covers a dual-action method and composition aimed at combating stress-induced pathophysiology and reducing various stress-induced psychiatric behaviors [3]. - Silo currently holds issued patents and has several expanded patent applications pending for SPC-15, which was licensed through a collaboration with Columbia University [2][4]. - A separate expanded provisional patent application has been filed to target NMDARs and 5-HT4Rs for extended behavioral effects against stress-induced behaviors [5]. Research and Development - SPC-15 is an intranasal serotonin 5-HT4 receptor agonist that has shown significant improvement in behavioral outcomes in preclinical studies [3][6]. - The company is collaborating with Columbia University for preclinical studies and has exclusive global rights for the development and commercialization of SPC-15 [6]. Future Prospects - The potential eligibility of SPC-15 for the FDA's streamlined 505(b)(2) regulatory pathway may accelerate its approval process [6].

Core Insights - Silo Pharma, Inc. has reported positive early data from an ongoing study of its SP-26 ketamine extended-release rods, indicating no serious side effects or discomfort in animal testing [1][2][3] - The SP-26 implant is designed for the treatment of chronic pain and fibromyalgia, with final safety and pharmacokinetic data expected in March 2025 [1][2][3] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on addressing underserved conditions such as chronic pain, stress-induced psychiatric disorders, and central nervous system diseases [4] - The company's portfolio includes innovative programs like SPC-15 for PTSD and SP-26 for chronic pain and fibromyalgia, with research conducted in collaboration with leading universities and laboratories [4] Product Details - SP-26 is a ketamine-based injectable dissolvable polymer implant aimed at safely regulating dosage and time release for pain relief [3] - If successful in clinical trials, SP-26 may qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval [3]

Company Overview - Silo Pharma Inc is a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, particularly for stress-induced psychiatric disorders, chronic pain, and CNS diseases [1][4] - The company's portfolio includes SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis [4] - Silo Pharma collaborates with leading universities and laboratories for its research [4] Intellectual Property and Pipeline Development - Silo Pharma filed a provisional patent application with the USPTO for its lead asset SPC-15, targeting NMDARs and 5-HT4Rs to address stress-induced psychiatric disorders [1][2] - The patent application aims to extend behavioral effects against stress-induced perseverative behavior and hyponeophagia [2] - SPC-15 is an intranasal serotonin 5-HT4 receptor agonist with potential eligibility for the FDA's 505(b)(2) regulatory pathway, which could accelerate approval [3] - The company has exclusive global rights to develop and commercialize SPC-15 through a collaboration with Columbia University [2][3] Strategic Focus and Leadership Commentary - Silo Pharma's intellectual property strategy is a cornerstone of its growth, with the latest provisional patent reinforcing strong IP protection for SPC-15 [3] - The company aims to deliver innovative therapies for patients with PTSD and other stress-induced disorders [3]

Core Viewpoint - Silo Pharma, Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent related to pharmacological prophylactics against stress-induced affective disorders in females, which will enhance the protection of its lead asset, SPC-15, an intranasal treatment for PTSD [1][2]. Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on creating novel therapeutics for underserved conditions, including stress-induced psychiatric disorders and chronic pain [4]. - The company is developing both traditional therapies and psychedelic treatments, with its lead program being SPC-15, aimed at treating PTSD and stress-induced anxiety disorders [4]. Patent and Intellectual Property - The newly allowed patent broadens the protection for SPC-15 and expands the company's technology rights, reinforcing its intellectual property portfolio [2]. - Silo holds an exclusive license agreement with Columbia University for the development, manufacturing, and commercialization of SPC-15 globally, which includes extensive issued patents and pending applications [2]. Product Details - SPC-15 is a serotonin 5-HT4 receptor agonist designed to treat stress-induced disorders such as PTSD and anxiety, delivered via an intranasal formulation [3]. - The product may qualify for the FDA’s streamlined 505(b)(2) regulatory pathway, potentially accelerating its approval process [3]. - Silo is currently collaborating with Columbia University on preclinical studies for SPC-15 [3].

Core Insights - Silo Pharma is progressing towards first-in-human trials for its lead candidate SPC-15, an intranasal treatment targeting PTSD and stress-induced anxiety disorders, with an IND submission expected in 2025 [2][5] - The company is also advancing its SP-26 ketamine implants aimed at chronic pain management, with animal studies set to begin in early 2025 [3][8] - Silo Pharma's innovative therapies are supported by collaborations with leading medical research partners, enhancing its intellectual property and market entry advantages [3] SPC-15 Development - SPC-15 is designed as a serotonin 5-HT4 receptor agonist for treating PTSD and anxiety, with a pre-IND meeting with the FDA completed in September 2024 [5][17] - The drug may also be explored for treating eating disorders and major depressive disorder based on promising pre-clinical data [6] - An exclusive global license for SPC-15 development has been granted to Silo by Columbia University [7] SP-26 Development - SP-26 is a ketamine-based implant targeting fibromyalgia and chronic pain, with a focus on providing a non-addictive alternative to opioids [8][18] - The implant's design aims to ensure safety and efficacy, with the potential to become the first at-home injectable ketamine therapeutic if approved [9] Regulatory Pathways - Both SPC-15 and SP-26 may qualify for the FDA's streamlined 505(b)(2) regulatory pathway, which could expedite their approval processes [10][11] - This pathway allows the use of existing data on active ingredients, potentially reducing clinical development costs and timelines [10] Market Trends - There is a significant unmet need for treatments targeting PTSD, with no new drug approvals in nearly 25 years for a condition affecting approximately 3.9% of the global population [12][13] - The Alzheimer’s disease treatment market is projected to grow to $30.8 billion by 2033, while the market for multiple sclerosis drugs is expected to reach $38.9 billion by 2032 [14] Financial Position - The company reports a strong balance sheet with cash on hand and minimal debt, providing financial flexibility for ongoing research and development [15]

Core Insights - Silo Pharma, Inc. has initiated a pharmacokinetic and tolerability study for its ketamine-based injectable implant, SP-26, aimed at treating chronic pain and fibromyalgia [1][3] - The study will assess the absorption, distribution, metabolism, and excretion of the extended-release ketamine hydrochloride implants over a three-week period [2] - SP-26 is designed as a self-administered, non-opioid therapeutic that could potentially qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval [4] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on novel therapeutics for underserved conditions, including chronic pain and psychiatric disorders [5] - The company is also developing other preclinical programs targeting conditions such as PTSD, Alzheimer's disease, and multiple sclerosis [5] - Silo Pharma collaborates with universities and independent laboratories for its research and development programs [5]

Financial Performance - For the three months ended September 30, 2024, the company reported a net loss of $928,814, or $0.22 loss per common share, compared to a net loss of $660,160, or $(0.21) loss per common share for the same period in 2023, representing an increase of 40.7%[145]. - Operating loss for the nine months ended September 30, 2024, was $2,892,342, an increase of 7.4% from $2,691,868 for the same period in 2023[140]. - The company reported a net loss of $2,662,260 for the nine months ended September 30, 2024, contributing to an accumulated deficit of $13,534,071[160]. Revenue and Income - The company generated minimal revenues of $18,025 for both the three months ended September 30, 2024, and 2023, with revenues recognized under the Aikido License and Sublicense Agreement[128]. - Other income for the three months ended September 30, 2024, decreased by 28.3% to $81,241 compared to $113,238 for the same period in 2023[142]. - The company incurred a total of $54,076 in license fee revenues for both the nine months ended September 30, 2024, and 2023[127]. Expenses - Total operating expenses for the three months ended September 30, 2024, were $1,026,621, an increase of 30.6% compared to $789,964 for the same period in 2023[130]. - Research and development expenses increased by 196.6% to $517,548 for the three months ended September 30, 2024, compared to $174,495 for the same period in 2023[135]. - Compensation expenses decreased by 55.3% to $169,736 for the three months ended September 30, 2024, compared to $379,294 for the same period in 2023[131]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024 was $2,916,482, an increase of $601,996 or 26% from $2,314,486 in the same period of 2023[151]. - Net cash provided by investing activities for the nine months ended September 30, 2024 was $1,011,436, a positive change of $9,587,447 or 111.8% from $(8,576,011) in 2023[153]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $3,241,628, a positive change of $3,414,741 or 1,272% from $(276,698) in 2023[156]. - The company generated a net increase in cash and cash equivalents of $1,336,582 for the nine months ended September 30, 2024, compared to a decrease of $(11,167,195) in the same period of 2023[149]. Assets and Liabilities - As of September 30, 2024, the company had working capital of $7,216,955, an increase of $311,387 or 5% from $6,905,568 as of December 31, 2023[148]. - Total current assets increased to $8,261,787 as of September 30, 2024, up by $580,629 or 8% from $7,681,158 as of December 31, 2023[148]. - Total current liabilities increased to $(1,044,832) as of September 30, 2024, an increase of $(269,242) or 35% from $(775,590) as of December 31, 2023[148]. Agreements and Commitments - The company entered into a securities purchase agreement on July 18, 2024, to sell 763,638 shares at a price of $2.75 per share, resulting in gross proceeds of approximately $2.1 million[121]. - The company signed an Exclusive License Agreement with Columbia University on July 1, 2024, to develop and commercialize SPC-15 worldwide[125]. - The company believes its current cash and cash equivalents, along with short-term investments, will be sufficient to meet obligations for at least twelve months from the date of the filing[159]. - The company has no material commitments for capital expenditures other than cash requirements pursuant to research and development agreements[159].

Core Insights - Silo Pharma, Inc. announced promising results from sterilization and dissolution tests of its SP-26 ketamine-loaded implant for fibromyalgia and chronic pain, indicating stability and consistent drug release [1][2] - The SP-26 implant demonstrated over 80% drug release over a 7-day period, highlighting its effective time-release formulation [2] - The company is also developing SPC-15, a novel serotonin 4 receptor agonist for PTSD and anxiety, which may qualify for the FDA's streamlined 505(b)(2) regulatory pathway [3] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on novel therapeutics for underserved conditions, including chronic pain and stress-induced psychiatric disorders [3] - The company's lead programs include SP-26 for chronic pain relief and SPC-15 for PTSD, with additional preclinical programs targeting Alzheimer's disease and multiple sclerosis [3]