Silo Pharma collaborates with Allucent for upcoming FDA IND submission for SPC-15
Partnership Announcement: Silo Pharma has selected Allucent, a global clinical research organization, to assist in the preparation and submission of its investigational new drug application (IND) for SPC-15, aimed at treating PTSD.
Timeline for Submission: The company plans to submit the IND to the FDA in 2026 and expects to begin its first-in-human trial of SPC-15 following FDA approval.
Study Data Expectations: Results from a GLP-compliant toxicology and toxicokinetic study, as well as a drug-device study for the intranasal spray system, are anticipated in early 2026.
Regulatory Pathway: Silo Pharma intends to utilize the FDA's 505(b)(2) accelerated regulatory pathway for the clinical development of SPC-15.
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Silo Pharma Partners with Allucent to Advance SPC-15 Clinical Studies
- Clinical Research Collaboration: Silo Pharma has signed a Letter of Intent with global CRO Allucent to conduct two Phase 1 studies for its SPC-15 nasal spray, marking a significant advancement in the treatment of psychiatric disorders.
- Study Design Details: The studies will include an Open-Label Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) design, aimed at efficiently generating safety and pharmacokinetic data to expedite SPC-15's clinical development.
- Strategic Importance: CEO Eric Weisblum stated that this collaboration will enhance the rigor and speed of the research, further advancing SPC-15's development to provide new therapies for PTSD and anxiety patients.
- Product Background: SPC-15 is an investigational intranasal 5-HT4 receptor agonist designed for rapid brain action using a special soft mist delivery system, with plans to leverage biomarkers for an accelerated FDA approval pathway.
Silo Pharma Enters LOI with Allucent for SPC-15 Clinical Studies
- Clinical Research Collaboration: Silo Pharma has signed a Letter of Intent with global CRO Allucent to conduct two Phase 1 studies for its SPC-15 nasal spray, marking a significant advancement in the treatment of PTSD and anxiety.
- Agreement Details: The LOI outlines comprehensive support for clinical operations, pharmacovigilance, and data management, which is expected to accelerate the clinical development of SPC-15, enhancing the company's competitiveness in the biopharmaceutical sector.
- Drug Development Context: SPC-15 is an investigational intranasal 5-HT4 receptor agonist targeting stress-induced psychiatric conditions, aiming for rapid brain action to alleviate PTSD and anxiety symptoms, indicating its potential market value.
- Long-term Value Creation: The CEO of Silo Pharma stated that this collaboration will facilitate the efficient generation of safety and pharmacokinetic data, further driving innovation and long-term growth in the mental health space.
Silo Pharma Collaborates with Allucent to Assist in Upcoming FDA Investigational New Drug Application for SPC-15 as a PTSD Treatment
Silo Pharma's IND Submission: Silo Pharma has partnered with Allucent to prepare for the submission of its investigational new drug application (IND) to the FDA for a Phase 1 clinical trial of its intranasal treatment SPC-15 for PTSD, expected in 2026.
Clinical Development Plans: The company aims to utilize Allucent's expertise to ensure the IND meets FDA standards, focusing on dose-ranging studies to evaluate the pharmacokinetics and safety of SPC-15.
Research and Development Focus: Silo Pharma is dedicated to developing therapies for underserved conditions, including PTSD, chronic pain, and CNS diseases, with a portfolio that includes multiple innovative programs.
Allucent's Role: Allucent is a global clinical research organization that provides comprehensive drug development solutions, leveraging over 30 years of experience to assist biopharma clients in navigating the complexities of bringing new therapies to market.
Silo Pharma Provides Update on Progress in PTSD Drug Development and Launches New Digital Assets Treasury Initiative
Biopharmaceutical Developments: Silo Pharma is preparing to submit an investigational new drug (IND) application for its lead candidate SPC-15, an intranasal treatment for PTSD, following positive safety study results and completion of necessary toxicology studies.
Digital Assets Strategy: The company has launched a digital assets treasury strategy, making initial cryptocurrency purchases and appointing a lead crypto strategy advisor to manage its portfolio and enhance compliance.
Future Catalysts: Key upcoming milestones include data from the IND-enabling study expected in 2026, FDA discussions to finalize IND submission requirements, and plans to expand therapeutic indications for SPC-15.
Company Overview: Silo Pharma focuses on developing treatments for underserved conditions, including PTSD and chronic pain, while also engaging in cryptocurrency investments to strengthen its capital resources.
Silo Pharma Completes $2.5 Million Registered Direct Offering at Market Price in Compliance with Nasdaq Regulations
Silo Pharma's Offering: Silo Pharma, Inc. has closed a registered direct offering of 2,857,143 shares of common stock at $0.875 per share, raising approximately $2.5 million for working capital and corporate purposes.
Warrants Issued: In a concurrent private placement, the company issued unregistered warrants to purchase an equal number of shares at an exercise price of $0.75, which are immediately exercisable and will expire in five years.
Regulatory Compliance: The common stock was offered under an effective registration statement with the SEC, while the unregistered warrants were offered in a private placement and are not registered under the Securities Act.
Company Focus: Silo Pharma is a developmental-stage biopharmaceutical company targeting underserved conditions such as PTSD and chronic pain, with research collaborations with leading universities and laboratories.
Silo Pharma Unveils $2.5 Million Registered Direct Offering Priced According to Nasdaq Regulations
Stock Offering Announcement: Silo Pharma, Inc. has entered into agreements to sell 2,857,143 shares of common stock at $0.875 per share in a registered direct offering, alongside a private placement of unregistered warrants for the same number of shares at an exercise price of $0.75.
Use of Proceeds: The company expects to raise approximately $2.5 million from the offering, which will be used for working capital and general corporate purposes, with the closing anticipated around October 1, 2025.
Company Overview: Silo Pharma focuses on developing innovative biopharmaceuticals for conditions like PTSD and chronic pain, collaborating with universities and laboratories for research.
Forward-Looking Statements: The press release includes forward-looking statements that involve risks and uncertainties, indicating that actual results may differ from expectations.
Silo Pharma Partners with Allucent to Advance SPC-15 Clinical Studies
- Clinical Research Collaboration: Silo Pharma has signed a Letter of Intent with global CRO Allucent to conduct two Phase 1 studies for its SPC-15 nasal spray, marking a significant advancement in the treatment of psychiatric disorders.
- Study Design Details: The studies will include an Open-Label Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) design, aimed at efficiently generating safety and pharmacokinetic data to expedite SPC-15's clinical development.
- Strategic Importance: CEO Eric Weisblum stated that this collaboration will enhance the rigor and speed of the research, further advancing SPC-15's development to provide new therapies for PTSD and anxiety patients.
- Product Background: SPC-15 is an investigational intranasal 5-HT4 receptor agonist designed for rapid brain action using a special soft mist delivery system, with plans to leverage biomarkers for an accelerated FDA approval pathway.
Silo Pharma Enters LOI with Allucent for SPC-15 Clinical Studies
- Clinical Research Collaboration: Silo Pharma has signed a Letter of Intent with global CRO Allucent to conduct two Phase 1 studies for its SPC-15 nasal spray, marking a significant advancement in the treatment of PTSD and anxiety.
- Agreement Details: The LOI outlines comprehensive support for clinical operations, pharmacovigilance, and data management, which is expected to accelerate the clinical development of SPC-15, enhancing the company's competitiveness in the biopharmaceutical sector.
- Drug Development Context: SPC-15 is an investigational intranasal 5-HT4 receptor agonist targeting stress-induced psychiatric conditions, aiming for rapid brain action to alleviate PTSD and anxiety symptoms, indicating its potential market value.
- Long-term Value Creation: The CEO of Silo Pharma stated that this collaboration will facilitate the efficient generation of safety and pharmacokinetic data, further driving innovation and long-term growth in the mental health space.
Silo Pharma Collaborates with Allucent to Assist in Upcoming FDA Investigational New Drug Application for SPC-15 as a PTSD Treatment
Silo Pharma's IND Submission: Silo Pharma has partnered with Allucent to prepare for the submission of its investigational new drug application (IND) to the FDA for a Phase 1 clinical trial of its intranasal treatment SPC-15 for PTSD, expected in 2026.
Clinical Development Plans: The company aims to utilize Allucent's expertise to ensure the IND meets FDA standards, focusing on dose-ranging studies to evaluate the pharmacokinetics and safety of SPC-15.
Research and Development Focus: Silo Pharma is dedicated to developing therapies for underserved conditions, including PTSD, chronic pain, and CNS diseases, with a portfolio that includes multiple innovative programs.
Allucent's Role: Allucent is a global clinical research organization that provides comprehensive drug development solutions, leveraging over 30 years of experience to assist biopharma clients in navigating the complexities of bringing new therapies to market.
Silo Pharma Provides Update on Progress in PTSD Drug Development and Launches New Digital Assets Treasury Initiative
Biopharmaceutical Developments: Silo Pharma is preparing to submit an investigational new drug (IND) application for its lead candidate SPC-15, an intranasal treatment for PTSD, following positive safety study results and completion of necessary toxicology studies.
Digital Assets Strategy: The company has launched a digital assets treasury strategy, making initial cryptocurrency purchases and appointing a lead crypto strategy advisor to manage its portfolio and enhance compliance.
Future Catalysts: Key upcoming milestones include data from the IND-enabling study expected in 2026, FDA discussions to finalize IND submission requirements, and plans to expand therapeutic indications for SPC-15.
Company Overview: Silo Pharma focuses on developing treatments for underserved conditions, including PTSD and chronic pain, while also engaging in cryptocurrency investments to strengthen its capital resources.
Silo Pharma Completes $2.5 Million Registered Direct Offering at Market Price in Compliance with Nasdaq Regulations
Silo Pharma's Offering: Silo Pharma, Inc. has closed a registered direct offering of 2,857,143 shares of common stock at $0.875 per share, raising approximately $2.5 million for working capital and corporate purposes.
Warrants Issued: In a concurrent private placement, the company issued unregistered warrants to purchase an equal number of shares at an exercise price of $0.75, which are immediately exercisable and will expire in five years.
Regulatory Compliance: The common stock was offered under an effective registration statement with the SEC, while the unregistered warrants were offered in a private placement and are not registered under the Securities Act.
Company Focus: Silo Pharma is a developmental-stage biopharmaceutical company targeting underserved conditions such as PTSD and chronic pain, with research collaborations with leading universities and laboratories.
Silo Pharma Unveils $2.5 Million Registered Direct Offering Priced According to Nasdaq Regulations
Stock Offering Announcement: Silo Pharma, Inc. has entered into agreements to sell 2,857,143 shares of common stock at $0.875 per share in a registered direct offering, alongside a private placement of unregistered warrants for the same number of shares at an exercise price of $0.75.
Use of Proceeds: The company expects to raise approximately $2.5 million from the offering, which will be used for working capital and general corporate purposes, with the closing anticipated around October 1, 2025.
Company Overview: Silo Pharma focuses on developing innovative biopharmaceuticals for conditions like PTSD and chronic pain, collaborating with universities and laboratories for research.
Forward-Looking Statements: The press release includes forward-looking statements that involve risks and uncertainties, indicating that actual results may differ from expectations.
