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]

Core Viewpoint - Silo Pharma, Inc. has announced a partnership with Sever Pharma Solutions to scale up the production of its SP-26 ketamine-based injectable implant aimed at treating chronic pain and fibromyalgia, with ongoing analytical testing to optimize the formulation [1][2]. Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on creating novel therapeutics for underserved conditions, including chronic pain and psychiatric disorders [4]. - The company's lead program, SPC-15, targets PTSD and stress-induced anxiety, while SP-26 is designed as a time-release ketamine implant for chronic pain relief [4]. Product Details - SP-26 is a ketamine-based injectable dissolvable polymer implant that aims to safely regulate dosage and time release for pain relief [3]. - The implant is currently undergoing pre-clinical studies to finalize its dosage and formulation, with the potential to qualify for the FDA's streamlined 505(b)(2) regulatory pathway if clinically successful [2]. Collaboration and Development - The collaboration with Sever Pharma Solutions builds on previous successful production and validation of the ketamine implants, indicating a strong partnership in advancing the product [2]. - The ongoing analytical testing will help in selecting the optimal final dosage and formulation for animal studies [2].

Silo to advance homing peptide development for initial indication in multiple sclerosis SARASOTA, FL, Aug. 07, 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 an agreement with WuXi AppTec (Hong Kong) Limited, a leading global contract research organization (CRO) ...

The gross proceeds to the Company from the offering were approximately $2.1 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with ...

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 rule ...

SARASOTA, FL, July 16, 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 an exclusive global license agreement to further develop, manufacture, and commercialize its Alzheimer's drug SPC-14. Silo intends to utilize the FDA's streamlined 505(b)(2) pathway for SPC-14 ...