INV4
2月前
Silo Pharma Positioned to Advance Treatment Targeting PTSD as President Trump Signs Executive Order Aimed at Accelerating Research and Treatment Based Upon Psychedelics
April 20, 2026
Silo Pharma, Inc. (NASDAQ: SILO), a developmental-stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today highlighted the strength and strategic positioning of its pipeline in response to increasing national attention and policy discussion surrounding psychedelic-based treatments for mental health disorders.
Recent national media coverage has underscored growing momentum at the federal level to evaluate reforms related to psychedelic compounds for medical use—particularly in areas such as post-traumatic stress disorder (PTSD), depression, and anxiety. On Saturday, April 18, 2026, President Trump signed an executive order directing multiple U.S. government agencies to accelerate research into psychedelic therapies and patient access.
Silo Pharma’s lead program, SPC-15, is an intranasal prophylactic treatment targeting PTSD, designed to leverage rapid nose-to-brain delivery for enhanced therapeutic effect and patient compliance. The program is being advanced under a 505(b)(2) regulatory pathway, potentially enabling a streamlined development timeline.
“Momentum at the national level around psychedelic therapeutics reflects what the science has been signaling for years—there is a critical need for new approaches to treating mental health conditions,” said Eric Weisblum, CEO of Silo Pharma. “We believe Silo is well positioned with SPC-15 and it broader CNS pipeline to potentially benefit from a more favorable regulatory and clinical environment.”
Key Highlights of SPC-15 (PTSD Program):
• Designed as a novel serotonin 4 (5-HT4) receptor agonist
• Targeting prophylactic treatment of PTSD and stress-induced disorders
• Administered via an intranasal formulation designed for rapid CNS delivery
• Backed by intellectual property licensed from Columbia University
• Preparing for IND engagement with the FDA
• Advanced drug delivery strategy
• Partnership for optimized intranasal device development
• Focus on nose-to-brain delivery platforms, a rapidly emerging segment in CNS therapeutics
Market Opportunity
The global mental health therapeutics market continues to expand, with PTSD alone affecting millions of individuals annually. Openness to psychedelic-assisted and psychedelic-derived therapies may unlock significant new treatment paradigms and commercial opportunities.
Silo Pharma believes that evolving regulatory frameworks could accelerate innovation across the sector, particularly for companies with clinically grounded, delivery-optimized, and IP-backed approaches.
About Silo Pharma, Inc.
Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease. Silo’s research is conducted in collaboration with leading universities and laboratories. For more information, please visit silopharma.com.
Forward Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at https://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact
investors@silopharma.com
(800) 705-0120
Link article
$SILO
INV4
2月前
Silo Pharma Receives European Patent Allowance for Licensed Novel PTSD Prevention Therapy
April 6, 2026
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 European Patent Office (EPO) has issued a Rule 71(3) communication indicating its intent to grant a patent for an European patent application titled “Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress” (European Patent Application No. 20786878.7) that the Company has an exclusive license from Columbia University.
The allowed claims cover methods of preventing stress-induced fear and depressive-like behavior and associated affective disorders using selected serotonin 4 (5-HT4) receptor agonists — a differentiated approach targeting pathways associated with stress resilience rather than just symptom management.
“This is a high-value milestone that strengthens our global intellectual property position and underscores the potential of our 5-HT4 program,” said Eric Weisblum, CEO of Silo Pharma. “We believe this approach represents a compelling shift toward proactive treatment of stress-related disorders, which remain a massive and underserved market.”
The patent, once granted, is expected to protect major European markets, further enhancing Silo’s strategic positioning as it advances its pipeline. The Company is evaluating Unitary Patent protection and key national validations to maximize geographic coverage and long-term value.
With growing global focus on mental health and stress-related conditions, Silo Pharma continues to build a portfolio targeting next-generation CNS therapeutics with differentiated mechanisms of action.
About Silo Pharma, Inc.
Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com
Forward Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including statements about the intended use of proceeds from the offering, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.
Contact
(800) 705-0120
investors@silopharma.com
Link article
$SILO 🗞️
subslover
1年前
Silo Pharma Issues Letter to Shareholders Detailing Development Progress and Potential for Lead Assets Targeting PTSD and Chronic Pain
IND submission for intranasal SPC-15 treatment expected in 2025; Phase 1 clinical trial to follow upon approval
SP-26 ketamine implants nearing first animal studies
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.
Dear fellow Silo Pharma shareholders,
Silo Pharma is gaining momentum along its path to first-in-human trials for lead candidate SPC-15, an intranasal prophylactic targeting PTSD and stress induced anxiety disorder. We are currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study and believe this will be the final data required before we submit an investigational new drug (IND) application to the FDA. I’m proud to report that we are getting closer to in-human trials.
In addition to SPC-15, we are advancing development of our SP-26 ketamine implant and continuing studies of our other investigational drugs. Each of these novel and potentially transformative therapies are tied to exclusive collaborations with world-class medical research partners, bringing valuable IP, assets and time-to-market advantages for Silo.
Through our ongoing commitment to developing novel therapeutics that address underserved conditions, Silo has created a robust platform of innovative solutions for mental health, chronic pain, and neurology.
SPC-15 | Intranasal PTSD Treatment
For our lead program, SPC-15, we completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in September 2024 regarding our development plan. The primary purpose of the meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 as we prepare for an expected IND submission in 2025, followed by a Phase 1 clinical trial in PTSD upon approval of our IND. This would be a significant milestone for Silo.
While the initial indications for SPC-15 are PTSD and stress, our pre-clinical data could also support a possible Phase 1 trial of SPC-15 as a treatment for eating disorders and anorexia. Additionally, promising results from another pre-clinical study showed that a dual-action approach of combining SPC-15, a 5-HT4R agonist, with an NMDA receptor (NMDAR) antagonist enhanced efficacy as compared to either agent alone for the treatment of major depressive disorder (MDD) and other severe stress-related conditions.
Columbia University, our collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide.
SP-26 | Ketamine-Loaded Implants
We continued our progress in the development and formulation of our novel SP-26 ketamine implants targeting fibromyalgia and chronic pain during 2024, and animal testing is scheduled to begin in early 2025. The unique design and development of the subcutaneous insertion device is expected to support sustained relief of chronic pain using a viable alternative to highly addictive opioid treatments.
Preclinical research to date has focused on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.
We have initiated our first animal study to evaluate dosage, time release, and absorption of the drug, and we expect to share these results in early 2025.
Approval Pathways
If clinically successful, both SCP-15 and SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Under Section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act (FDCA), drug developers can use publicly available data on active ingredients in a compound for a new drug application (NDA). This streamlined pathway allows for significantly shortened clinical timelines and reduced clinical development costs as compared to the conventional full NDA process.
We believe this strategy could simplify our clinical plans and allow for a faster approval process, potentially accelerating our delivery of effective solutions for patients with access to few, if any, proven therapeutics.
Market Trends
The blood-brain barrier (BBB) is a major hurdle for the development of systemically delivered drugs targeting diseases of the central nervous system (CNS). Because of this barrier there is a huge unmet need for the treatment of these diseases, despite years of clinical research efforts across the pharmaceutical industry.1
For PTSD, there have been no new drug approvals in nearly 25 years for a condition that affects an estimated 3.9% of the world’s population.2 The Only FDA-approved drugs for fibromyalgia are two antidepressants and one anti-seizure medicine.3
Each of our neurology programs, SPC-14 for the treatment of Alzheimer’s disease and SPU-15 for the treatment of multiple sclerosis, address very large and growing markets. The Alzheimer’s disease treatment market shows projected growth to $30.8B in 2033, at 18.8% CAGR,4 and the global market for multiple sclerosis drugs is projected to grow to $38.9B by 2032, at a 7.9% CAGR.5
Creating Value
In closing, we believe our progress in 2024 sets us up for exciting developments and milestones for Silo in 2025. Our current balance sheet, with cash on hand and minimal debt, offers financial flexibility as we move forward with ongoing research and development of therapies with the potential to transform patient care.
Silo Pharma is committed to delivering compelling catalysts for value creation for our existing and future shareholders. We are enthusiastic about the future and grateful for your interest and continued support.
Sincerely,
Eric Weisblum
Chief Executive Officer
December 2024
About SPC-15
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, SPC-15 may qualify for the FDA’s streamlined 505(b)(2) regulatory pathway, potentially accelerating its approval process. Currently, Silo Pharma is collaborating with Columbia University on preclinical studies and holds exclusive rights to develop and commercialize SPC-15 globally.
About SP-26
SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with universities and independent laboratories. For more information, visit www.silopharma.com and connect on social media at LinkedIn, X, and Facebook.
Forward-Looking Statements
subslover
2年前
Silo Pharma Enters Joint Development Agreement for SP-26 Ketamine Implant Device Targeting Pain Management
Prototype development and feasibility testing underway for optimized subcutaneous delivery
SARASOTA, FL, Nov. 29, 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 a collaboration agreement with Kymanox for specialized design and development of a subcutaneous insertion device for SP-26, the Company’s ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain.
Under terms of the agreement, Kymanox will conduct an initial proof-of-concept design phase followed by full system prototype and feasibility testing to determine optimal insertion depth in tissue.
“Previous analytical testing and proof-of-concept extrusion trials have confirmed the optimal formulation for our SP-26 implants. Now we are advancing this program to develop a novel insertion device that is intended to be tested in continuing preclinical studies,” said Silo CEO Eric Weisblum. “We are pleased with the steady progress we are making with our proposed ketamine implants, which are being uniquely designed with a goal of providing sustained relief of chronic pain.”
Preclinical research to date has focused, in part, on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.
In addition to the SP-26 agreement, Kymanox is Silo’s regulatory partner for SPC-15, a targeted prophylactic treatment for stress-induced affective disorders including PTSD.
About SP-26
Silo’s SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
subslover
2年前
Silo Pharma Announces Partnership with Global CRO for Central Nervous System Homing Peptide
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), for a preclinical small animal study of SPU-16, a central nervous system (CNS) homing peptide targeting multiple sclerosis (MS). Silo Pharma is advancing the development of the SPU-16 liposomal homing peptide through a commercial evaluation license and option agreement with the University of Maryland, Baltimore (UMB).
The study will examine the organ/tissue specificity of the SPU-16 peptide in an experimental autoimmune encephalomyelitis (EAE) protocol, is the most commonly used experimental model for MS. The peptide’s proven ability to target inflamed epithelium suggests that it can be used as a targeted drug delivery tool to address inflammation in the spinal cord.
“We are excited to launch this new study of our novel CNS homing peptide under the management of WuXi AppTec, one of the largest CROs in Asia and globally,” said Silo CEO Eric Weisblum.1 “Designed to cross the blood-brain barrier and target damaged tissue and inflammation, SPU-16 has been shown to enhance the therapeutic effect of current and future therapeutics while decreasing the toxicity of the drugs. While we are currently investigating the peptide for MS, it could provide similar benefits for multiple neuroinflammatory pathologies.”
MS, a human inflammatory demyelinating disease, is one of the most widespread disabling neurological conditions of young adults.2 The global multiple sclerosis drugs market size is projected to grow at a compound annual growth rate (CAGR) of 7.9% from $21.2 billion in 2024 to $38.9 billion by 2032.3
subslover
2年前
Silo Pharma Secures Exclusive Global License for Alzheimer's Therapeutic
Agreement enhances Company’s intellectual property portfolio
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, which would shorten clinical timelines and reduce drug development costs.
“In our view, our exclusive license for SPC-14 gives us the potential to meet a large unmet medical need. If approved, we believe SPC-14 could bring hope and relief for many families and patients. Early pre-clinical studies have shown stress reduction and cognitive improvement,” said Silo CEO Eric Weisblum.
Silo Pharma recently announced a similar exclusive license agreement for its lead drug candidate, SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.
The global Alzheimer’s disease therapeutics market size is forecasted to exceed $30.8 billion by 2033, with a CAGR of 18.8% from 2024 to 2033 1 . Rising prevalence of the disease in the expanding elderly population and advancements in neurological research are expected to drive market growth.
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