Silo Pharma(SILO)

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Silo Pharma Announces Completion of Dosing in Safety Study of PTSD Drug SPC-15
Globenewswireยท 2025-07-16 12:45
Core Insights - Silo Pharma, Inc. has completed dosing in a large animal study requested by the FDA for its lead asset SPC-15, with results expected in 60 days [1] - The company is confident in the safety and therapeutic delivery of SPC-15 and is on track to submit an investigational new drug (IND) application [2] - Silo plans to utilize the FDA's 505(b)(2) regulatory pathway for SPC-15, which could expedite clinical timelines and reduce development costs [3] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and CNS diseases [5] - The company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia, and preclinical assets targeting Alzheimer's disease and multiple sclerosis [5] - Silo collaborates with leading universities and laboratories for its research initiatives [5] Product Details - SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders like PTSD and anxiety [4] - The drug has potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway, which may accelerate its approval process [4] - Silo Pharma has exclusive global rights for the development and commercialization of SPC-15 in collaboration with Columbia University [4]
Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025
Globenewswireยท 2025-07-07 12:15
Core Insights - Silo Pharma, Inc. is developing SPC-15, an intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD), with plans to submit an Investigational New Drug (IND) application by the end of 2025 [1][4] - The company anticipates receiving preclinical study data for SPC-15 within 30 to 90 days, which will inform the IND application process [1][4] - SPC-15 aims to address a significant unmet need in the PTSD treatment market, as there have been no new drug approvals for PTSD in nearly 25 years, despite the condition affecting approximately 3.9% of the global population [6] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on novel therapeutics for underserved conditions, including stress-induced psychiatric disorders and chronic pain [8] - The company collaborates with Columbia University for preclinical studies and holds exclusive global rights for the development and commercialization of SPC-15 [7][8] - Silo Pharma's portfolio includes other programs targeting fibromyalgia, chronic pain, Alzheimer's disease, and multiple sclerosis [8] Drug Development Process - The final studies for SPC-15 include a Good Laboratory Practice-compliant toxicology study and a large animal safety study requested by the FDA [2] - The company plans to utilize the FDA's 505(b)(2) regulatory pathway for SPC-15, which could expedite the approval process and reduce development costs [5] - If the IND application is approved, Silo Pharma could initiate a Phase 1 clinical trial for SPC-15 by the end of 2026 [4]
Silo Pharma Enters into Letter of Intent to Form Joint Venture with Hoth Therapeutics to Develop Obesity Treatment Targeting $16 Billion Global Market
Globenewswireยท 2025-06-25 12:38
Core Insights - Silo Pharma has entered into a non-binding letter of intent to form a 50:50 joint venture with Hoth Therapeutics to develop a treatment for obesity and metabolic diseases based on technology licensed from the U.S. Department of Veterans Affairs [1][3] - The joint venture aims to leverage a novel therapeutic platform centered on glial cell line-derived neurotrophic factor (GDNF), which has shown anti-obesity effects in preclinical models [2][4] - The obesity market is valued at approximately $16 billion, with the potential for significant impact on veterans and civilians suffering from metabolic disorders [3][4] Unmet Need - Over 40% of U.S. adults are affected by obesity, which is a leading risk factor for various health issues, including diabetes and cardiovascular disease [4] - Veterans face unique challenges related to obesity, including chronic inflammation and PTSD-related metabolic disruptions, highlighting the need for effective treatments [4] Strategic Alignment - The partnership will utilize the exclusive U.S. license from the Department of Veterans Affairs, ensuring comprehensive coverage for all fields of use [7] - The joint venture structure allows for equal equity and governance participation between Silo Pharma and Hoth Therapeutics [7] - The collaboration combines the clinical infrastructure of the VA, Hoth's regulatory expertise, and Silo's translational capabilities [8]
Silo Pharma Secures Biomarker Patent for Novel PTSD Therapeutic SPC-15 as Clinical Trial Nears
Globenewswireยท 2025-06-11 13:00
Core Viewpoint - Silo Pharma, Inc. has received a Notice of Allowance for a patent that will enhance its intellectual property protection for its lead asset, SPC-15, which targets PTSD treatment [1][2] Group 1: Patent and Intellectual Property - The U.S. Patent and Trademark Office will issue a patent for biomarkers related to prophylactic treatments against stress-induced affective disorders, expected to be U.S. Patent No. 12,329,726 on June 17, 2025 [1][2] - This patent strengthens Silo's IP protection for SPC-15, an intranasal treatment for PTSD [2][3] Group 2: Product Development - SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders, including PTSD and anxiety [4] - The product is eligible for the FDA's streamlined 505(b)(2) regulatory pathway, potentially accelerating its approval process [4] - Silo Pharma is preparing to initiate Phase 1 clinical trials for SPC-15 [3] Group 3: Company Overview - Silo Pharma focuses on developing treatments for underserved conditions such as stress-induced psychiatric disorders, chronic pain, and CNS diseases [5] - The company's portfolio includes other innovative programs like SP-26 for fibromyalgia and chronic pain, as well as preclinical assets targeting Alzheimer's disease and multiple sclerosis [5]
Silo Pharma Board of Directors Approves Purchase of Bitcoin as Treasury Reserve Asset
Globenewswireยท 2025-06-05 13:15
Core Insights - Silo Pharma, Inc. has approved the purchase of up to $1 million in Bitcoin as a treasury reserve asset to diversify its holdings and provide a digital store of value with significant upside potential [1][2] - The CEO of Silo Pharma stated that this strategic decision aims to safeguard against inflation and optimize long-term shareholder value [2] Company Overview - Silo Pharma, Inc. is a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems [1] - The company addresses underserved conditions such as stress-induced psychiatric disorders, chronic pain, and central nervous system diseases [2] - Silo's portfolio includes innovative programs targeting PTSD, fibromyalgia, chronic pain, Alzheimer's disease, and multiple sclerosis, with research conducted in collaboration with leading universities and laboratories [2]
Silo Wellness to Relist as Born Defense, a National Security Investment Issuer Focused on Ending Forever Wars and Upholding the Just War Doctrine
Newsfileยท 2025-06-02 10:11
Core Viewpoint - Silo Wellness Inc. is transitioning to "Born Defense," focusing on defense and national security investments, guided by the Just War Doctrine, aiming to end "forever wars" and promote responsible national self-defense [1][4]. Company Transition and Strategic Focus - Born Defense will invest in advanced defense technologies, including cybersecurity, autonomous systems, and advanced manufacturing, supporting Canada's defense sector growth in line with NATO's 2% GDP defense spending target by 2027 [2][6]. - The company plans to explore high-potential investments across North America and Europe, delivering ethical and scalable defense solutions [2]. Investment Strategy - The global defense market is projected to reach $676.64 billion by 2029, growing at a 6.4% CAGR, positioning Born Defense to capitalize on growth opportunities [5][6]. - The company aims to leverage strategic capital and deep industry networks to support innovative companies addressing modern security threats [5]. Geopolitical Context - Rising global tensions, including conflicts in Eastern Europe and cybersecurity threats, are driving demand for innovative defense solutions [6][7]. - Born Defense's commitment to ending "forever wars" aligns with the increasing investor interest in socially responsible opportunities [7]. Proposed Changes and Governance - The company will hold a shareholder meeting to approve the name change and elect a board with defense and national security expertise, resulting in a change of control [9]. - The completion of the proposed transaction is subject to various approvals, including financing and regulatory [10]. Divestment and Future Focus - The company plans to divest its psychedelic assets to focus resources on the defense industry, which is seen as having greater growth potential [11][13]. - There is an openness to explore investments in psychedelic therapy aligned with Department of Defense research for PTSD and traumatic brain injuries [11]. Funding and Compliance - Funding for necessary audits and listing statements has been secured, and the company is working to revoke a Cease Trade Order issued due to delayed financial filings [15].
Silo Pharma Partners with Resyca for IND-Supporting Intranasal Drug-Device Study of PTSD Drug SPC-15
Globenewswireยท 2025-05-21 12:55
Core Insights - Silo Pharma has entered into a service agreement with Resyca BV for a drug-device study of its lead asset SPC-15, aimed at treating PTSD through a microchip-based nasal spray system [1][2] - The study is expected to provide final device data and documentation necessary for the FDA IND submission planned for this year [2] - SPC-15 is a serotonin 5-HT4 receptor agonist targeting stress-induced psychiatric disorders, with potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway [3] Company Overview - Silo Pharma Inc. is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and CNS diseases [5] - The company's portfolio includes innovative programs such as SPC-15 for PTSD and SP-26 for fibromyalgia and chronic pain, along with preclinical assets targeting Alzheimer's disease and multiple sclerosis [5] Partner Overview - Resyca BV, founded in 2020, specializes in developing and manufacturing soft mist inhalation and nasal spray devices, utilizing proprietary micro-nozzle technology [4] - Resyca is a joint venture between Bespak Limited and Medspray Pharma BV, offering comprehensive services from early-stage development to commercial production [4]
Silo Pharma Announces Closing of $2 Million Public Offering
Globenewswireยท 2025-05-16 20:15
Core Viewpoint - Silo Pharma, Inc. has successfully completed a public offering of 3,333,338 shares of common stock at a price of $0.60 per share, raising approximately $2 million in gross proceeds for general working capital purposes [1][2]. Group 1: Offering Details - The public offering includes Series A-1 and Series A-2 warrants, each with an exercise price of $0.60 per share [1]. - Series A-1 Warrants are exercisable upon issuance and expire five years thereafter, while Series A-2 Warrants expire eighteen months after issuance [1]. - H.C. Wainwright & Co. acted as the exclusive placement agent for the offering [2]. Group 2: Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on addressing underserved conditions such as stress-induced psychiatric disorders, chronic pain, and central nervous system diseases [5]. - The company's portfolio includes innovative programs targeting PTSD, fibromyalgia, chronic pain, Alzheimer's disease, and multiple sclerosis [5]. - Research is conducted in collaboration with leading universities and laboratories [5].
Silo Pharma Announces Pricing of $2 Million Public Offering
Globenewswireยท 2025-05-15 13:15
Core Viewpoint - Silo Pharma, Inc. has announced a public offering of 3,333,338 shares of common stock at a price of $0.60 per share, along with associated warrants, aiming to raise approximately $2 million for general working capital purposes [1][2]. Group 1: Offering Details - The public offering includes 3,333,338 shares of common stock and two series of warrants (Series A-1 and Series A-2), each with an exercise price of $0.60 per share [1]. - The Series A-1 Warrants are exercisable upon issuance and will expire five years thereafter, while the Series A-2 Warrants will expire eighteen months after issuance [1]. - The closing of the offering is expected to occur on or about May 16, 2025, subject to customary closing conditions [1]. Group 2: Financial Aspects - The gross proceeds from the offering are expected to be approximately $2 million before deducting fees and expenses [2]. - The net proceeds will be used for general working capital purposes [2]. Group 3: Company Overview - Silo Pharma, Inc. is a developmental stage biopharmaceutical company focused on addressing underserved conditions such as stress-induced psychiatric disorders, chronic pain, and CNS diseases [5]. - The company's portfolio includes innovative programs targeting PTSD, fibromyalgia, chronic pain, Alzheimer's disease, and multiple sclerosis [5]. - Research is conducted in collaboration with leading universities and laboratories [5].
Silo Pharma Selects Veloxity Labs for Bioanalytical IND-Enabling Study for our Novel Intranasal PTSD Therapy, SPC-15
Globenewswireยท 2025-05-14 20:07
Core Insights - Silo Pharma, Inc. has engaged Veloxity Labs for bioanalysis to support the ongoing GLP-compliant toxicology study of its lead asset, SPC-15, which is an intranasal treatment for PTSD [1][2] - The company anticipates starting the FDA IND process for SPC-15 in 2025, with plans to proceed to a Phase 1 clinical trial upon IND approval [2] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on addressing underserved conditions such as stress-induced psychiatric disorders, chronic pain, and CNS diseases [3] - The company's portfolio includes innovative programs like SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis [3] - Research is conducted in collaboration with leading universities and laboratories [3]