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and foreign laws and regulations, or changes in the laws and regulations may result in interruptions to our development activity or business continuity.
Even if any of our future therapeutic candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense or penalties if we fail to comply with regulatory requirements.
We may become exposed to costly and damaging liability claims, and our product liability insurance may not cover all damages from such claims.
Risks Relating to Investing in Digital Securities The launch of central bank digital currencies ( CBDCs ) may adversely impact our business.
Absent federal regulations, there is a possibility that any digital asset we acquire may be classified as a security.
Any classification of any digital asset we acquire as a security would subject us to additional regulation and could materially impact the operation of our business.
If we were deemed to be an investment company under the 1940 Act, applicable restrictions likely would make it impractical for us to continue segments of our business as currently contemplated.
We may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business, financial condition, and results of operations.
Cryptocurrency assets are less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents.
We are not subject to legal and regulatory obligations that apply to investment companies such as mutual funds and exchange-traded funds, or to obligations applicable to investment advisers.
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Cash held in non-interest-bearing and interest-bearing operating accounts may exceed the Federal Deposit Insurance Corporation ( FDIC ) insurance limits.
If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations.
Any material loss that we may experience in the future could have an adverse effect on our ability to pay our operational expenses or make other payments.
To mitigate our risk, in March 2023 we began transferring our cash to other banks to ensure that our exposure is limited or reduced to the FDIC protection limits.
BUSINESS Overview We are a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including PTSD, stress-induced anxiety disorders, fibromyalgia, and central nervous system (CNS) diseases.
1 Product Candidates We are currently focusing on four product candidates: 1.
Initial animal studies, which began in early 2025, are evaluating the implant's dosage, time release, and absorption.
2 In March 2023, we filed a provisional patent application with the USPTO to use SP-26 for treatment of chronic pain, including fibromyalgia.
SPC-14 was developed under a sponsored research agreement with Columbia University See ---Investigator-Sponsored Study Agreements between the Company and Vendors---Sponsored Research Agreement with Columbia University for the Study of Ketamine in Combination with Other Drugs for Treatment of Alzheimer s and Depression Disorders, and we have exclusive global rights to develop and commercialize SPC-14, pursuant to that certain exclusive license agreement entered into with Columbia on July 1, 2024.
4 Commercial Evaluation License and Option Agreement with UMB for Joint Homing Peptide Effective as of February 26, 2021, we, through our wholly-subsidiary, Silo Pharma, Inc., a Florida corporation, and University of Maryland, Baltimore ( UMB ), entered into a commercial evaluation license and option agreement ( License Agreement ), which we were granted an exclusive, non-sublicensable, non-transferable license to with respect to the exploration of the potential use of joint-homing peptides for use in the investigation and treatment of arthritogenic processes.