Silo Pharma, Inc. is a developmental stage biopharmaceutical company focused on developing novel therapeutics and drug delivery systems to address underserved conditions. The company's pipeline encompasses a diverse array of innovative treatments targeting areas such as post-traumatic stress disorder (PTSD), chronic pain, Alzheimer's disease, and multiple sclerosis.
Business Overview and History
Silo Pharma has a rich history dating back to its incorporation in New York in 2010 under the name Gold Swap, Inc. The company underwent several transformations, changing its name to Uppercut Brands, Inc. in 2019 and finally to Silo Pharma, Inc. in 2020. In 2013, the company changed its state of incorporation from New York to Delaware, positioning itself for growth and expansion. This transition also marked the beginning of Silo Pharma's shift towards developing novel therapeutics, including those utilizing conventional drugs and psychedelic formulations.
In 2020, Silo Pharma incorporated a new wholly-owned subsidiary, Silo Pharma Inc., in the state of Florida, establishing a dedicated entity to advance its biopharmaceutical research and development efforts. The company navigated various challenges during this period, including securing necessary funding and establishing key partnerships to support its innovative pipeline.
A significant development occurred in late 2023 when Silo Pharma reincorporated from Delaware to Nevada. This strategic move allowed the company to take advantage of Nevada's business-friendly environment and regulatory framework, positioning it for continued success. The company's current headquarters are located in Sarasota, Florida.
Throughout its history, Silo Pharma has remained committed to advancing its novel therapeutic candidates, focusing on underserved conditions such as PTSD, chronic pain, and Alzheimer's disease. The company has evolved into a biopharmaceutical innovator dedicated to developing unique formulations and delivery systems for traditional therapeutics as well as psychedelic treatments.
Financials and Liquidity
Silo Pharma's financial performance has been marked by consistent net losses as the company remains in the developmental stage. For the year ended December 31, 2023, the company reported revenue of $72,100 and a net loss of $3.70 million, with an accumulated deficit of $10.87 million as of that date. The company's cash and cash equivalents totaled $3.52 million, with short-term investments of $4.14 million, providing a strong liquidity position to fund its ongoing research and development efforts.
During the nine months ended September 30, 2024, Silo Pharma reported minimal revenues of $54,080, derived from license fee arrangements, with a cost of revenues of $4,380. The company's net loss for this period was $2.66 million, compared to a net loss of $2.58 million in the same period of the prior year. Operating expenses totaled $2.94 million, consisting of compensation expense of $511,460, professional fees of $899,950, research and development costs of $1.29 million, insurance expense of $63,910, and selling, general and administrative expenses of $174,280.
The company's cash and cash equivalents increased to $4.86 million, with short-term investments of $3.15 million, as of September 30, 2024. This improved liquidity was driven by the successful completion of two registered direct offerings in June and July 2024, which generated net proceeds of $3.41 million. As of the most recent quarter, Silo Pharma had a working capital of $7.22 million, a current ratio of 7.90, and a quick ratio of 7.90, indicating a strong short-term financial position.
In the most recent quarter (Q3 2024), the company reported revenue of $18,025 and a net loss of $928,814. Year-over-year, revenue remained flat while net loss increased by 40.7% from Q3 2023, primarily due to higher research and development expenses.
Silo Pharma operates solely in the United States and has no debt, with a debt/equity ratio of 0 as of the most recent quarter. The company has not disclosed any available credit lines or facilities.
Silo Pharma's Research and Development Pipeline
SPC-15 (Intranasal PTSD Treatment)
Silo Pharma's lead asset, SPC-15, is an intranasal formulation targeting the treatment of post-traumatic stress disorder (PTSD) and stress-induced anxiety disorders. In January 2025, the company announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent application covering the "Pharmacological Prophylactics Against Stress-Induced Affective Disorders in Females." This patent, once formally issued, will provide additional intellectual property protection for the SPC-15 asset.
Silo Pharma has completed a pre-Investigational New Drug (pre-IND) meeting with the FDA regarding the development plan for SPC-15. The company plans to submit an IND application for this intranasal PTSD treatment in 2025, with the goal of initiating first-in-human clinical trials shortly thereafter.
SP-26 (Ketamine-based Implant for Chronic Pain)
Silo Pharma's SP-26 is a novel, self-administered, ketamine-based implant designed to treat chronic pain and fibromyalgia. In December 2024, the company announced the initiation of a pharmacokinetic and tolerability study in partnership with its contract research organization, AmplifyBio. This non-GLP study is evaluating the absorption, distribution, metabolism, and excretion of the SP-26 extended-release ketamine hydrochloride implants in a minipig model.
Additionally, in November 2024, Silo Pharma entered into a collaboration agreement with Kymanox for the specialized design and development of a subcutaneous insertion device for the SP-26 implant. This partnership aims to optimize the delivery of the ketamine-loaded implant.
SPC-14 (Intranasal Alzheimer's Treatment) and SPU-16 (Multiple Sclerosis Homing Peptide)
Beyond its lead assets, Silo Pharma's pipeline includes SPC-14, an intranasal compound for the treatment of Alzheimer's disease, and SPU-16, a central nervous system (CNS) homing peptide targeting multiple sclerosis. The company has established various research and development collaborations to advance these programs, including a partnership with WuXi AppTec for the preclinical development of the SPU-16 homing peptide.
Intellectual Property and Partnerships
Silo Pharma has built a robust intellectual property portfolio to protect its innovative therapeutic candidates. The company holds exclusive license agreements with the University of Maryland, Baltimore (UMB) and Columbia University, granting it rights to develop and commercialize various assets within its pipeline.
In addition to its internal R&D efforts, Silo Pharma has forged strategic partnerships to accelerate the advancement of its programs. These collaborations include agreements with contract research organizations, such as AmplifyBio and WuXi AppTec, as well as a development agreement with Sever Pharma Solutions for the scale-up and analytical testing of the SP-26 ketamine implant.
Silo Pharma has also entered into a patent license agreement and a sublicense agreement with Aikido Pharma Inc., granting the latter exclusive rights to develop and commercialize certain assets in specific fields of use.
Regulatory Milestones and Outlook
Silo Pharma has made significant progress in its regulatory strategy, as evidenced by the recent completion of a pre-IND meeting with the FDA regarding the development of its lead asset, SPC-15, for the treatment of PTSD. The company plans to submit an IND application for this intranasal treatment in 2025, with the goal of initiating first-in-human clinical trials shortly thereafter.
The company's other pipeline assets, such as SP-26 for chronic pain and fibromyalgia, are also advancing through key preclinical milestones. The ongoing pharmacokinetic and tolerability study for the SP-26 ketamine implant, as well as the collaboration with Kymanox for the specialized delivery device, are important steps in the product's development.
Silo Pharma's strategic focus on developing innovative therapeutics and drug delivery systems for underserved conditions positions the company well to address significant unmet medical needs. The company's robust intellectual property portfolio, collaborations with renowned research institutions and CROs, and progress in regulatory submissions suggest a promising future for Silo Pharma's pipeline.
Risks and Challenges
As a developmental stage biopharmaceutical company, Silo Pharma faces several risks and challenges common to the industry, including:
1. Clinical Development Risks: The successful advancement of the company's pipeline assets through clinical trials is critical, but inherently uncertain. Failure to demonstrate the desired safety and efficacy profiles could significantly impact the company's prospects.
2. Regulatory Approval Uncertainty: Even if the company's product candidates successfully complete clinical trials, there is no guarantee that they will receive regulatory approvals from the FDA or other governing bodies, which would prevent commercialization.
3. Funding and Liquidity Constraints: As a pre-revenue company, Silo Pharma's ability to fund its ongoing research and development activities is crucial. While the company has recently bolstered its cash position through equity financings, its long-term liquidity remains a key concern.
4. Competition and Technological Advancements: Silo Pharma operates in a highly competitive biopharmaceutical landscape, where emerging technologies and rival product candidates may challenge the company's market position and commercial viability.
5. Reliance on Partnerships and Licenses: The company's success is partially dependent on the performance and continuation of its various research collaborations and intellectual property licensing agreements. The termination or disruption of these arrangements could significantly impact Silo Pharma's operations.
Despite these risks, Silo Pharma's focus on developing innovative solutions for underserved patient populations, its growing intellectual property portfolio, and its strategic partnerships provide a strong foundation for the company's future growth and development.
Industry Trends
The small-cap biopharmaceutical industry, in which Silo Pharma operates, has experienced a compound annual growth rate (CAGR) of approximately 8-10% over the past 5 years. This growth has been primarily driven by increased R&D investment and a focus on innovative drug development. However, the industry also faces significant challenges, including high clinical trial costs and complex regulatory hurdles.
As a company operating in this dynamic sector, Silo Pharma is well-positioned to capitalize on the industry's growth trends while navigating its inherent challenges. The company's focus on developing novel therapeutics for underserved conditions aligns with the broader industry trend of addressing unmet medical needs through innovative approaches.
Conclusion
Silo Pharma is a promising biopharmaceutical company dedicated to addressing unmet medical needs through the development of novel therapeutics and drug delivery systems. The company's diversified pipeline, with lead assets targeting PTSD, chronic pain, Alzheimer's disease, and multiple sclerosis, showcases its commitment to tackling significant healthcare challenges.
Silo Pharma's progress in advancing its regulatory strategies, expanding its intellectual property, and forging strategic collaborations demonstrates the company's ability to navigate the complex biopharmaceutical landscape. As the company continues to execute on its development roadmap, investors should closely monitor Silo Pharma's ability to achieve key milestones, such as IND submissions, initiation of clinical trials, and potential regulatory approvals.
While Silo Pharma faces the inherent risks associated with a developmental stage biopharmaceutical company, its innovative approach, growing pipeline, and strong liquidity position suggest a compelling investment opportunity for those seeking exposure to the promising field of specialty pharmaceutical innovation. The company's focus on both conventional drugs and psychedelic formulations positions it at the forefront of emerging therapeutic approaches, potentially opening up new avenues for treating complex neurological and psychiatric conditions.
As Silo Pharma continues to advance its product candidates through various stages of development, its financial performance and market position are likely to evolve. The company's ability to successfully navigate clinical trials, secure regulatory approvals, and eventually commercialize its innovative therapies will be critical factors in determining its long-term success and value creation for shareholders.