10-K: Silo Pharma Navigates Biopharma & Crypto, Reports $4.2M Loss

Silo Pharma, a developmental-stage biopharmaceutical and cryptocurrency company, reported a net loss of $4.2 million for 2025 while advancing its drug pipeline and managing a volatile digital asset treasury.

Summary

• Silo Pharma is a developmental-stage biopharmaceutical and cryptocurrency company focused on novel therapeutics for PTSD, stress-induced anxiety disorders, fibromyalgia, and central nervous system (CNS) diseases.
• The company's lead product candidate, SPC-15 (intranasal for PTSD and stress-induced anxiety disorders), completed preclinical and formulation studies in the first half of 2024, had a pre-IND meeting with the FDA in September 2024, and is aiming for an IND submission in 2026.
• SP-26, a ketamine-based injectable dissolvable polymer implant for fibromyalgia and chronic pain, is currently in preclinical research, with initial animal studies beginning in early 2025.
• SPC-14, an intranasal compound for Alzheimer's disease, was developed under a sponsored research agreement with Columbia University, and the company holds exclusive global rights to develop and commercialize it.
• The Master License Agreement with the University of Maryland, Baltimore (UMB) for SPU-16 (CNS-homing peptide for multiple sclerosis) was terminated on July 8, 2025, and replaced with an exclusive option agreement expiring March 31, 2026, which the company does not intend to extend.
• In August 2025, the company adopted a cryptocurrency treasury strategy, acquiring Bitcoin (BTC), Ethereum (ETH), Solana (SOL), Liquid Staked ETH (LsETH), and Marinade Solana (mSOL).
• As of December 31, 2025, the company had $98,584 of crypto assets at cost (staked) and $221,817 of crypto assets at fair value.
• The net loss for the year ended December 31, 2025, was $4,227,698, a decrease from $4,392,880 in 2024.
• Operating loss for 2025 was $4,280,662, compared to $4,705,694 in 2024.
• Revenues remained minimal at $72,102 for both 2025 and 2024, while cost of revenues increased significantly to $44,295 in 2025 from $5,838 in 2024 due to accelerated amortization of license fees.
• Working capital increased by 24% to $6,737,542 as of December 31, 2025, from $5,455,483 in 2024.
• Cash and cash equivalents increased to $4,748,700 as of December 31, 2025, from $3,905,799 in 2024.
• The company received a Nasdaq notification on June 27, 2025, for non-compliance with the minimum bid price requirement ($1.00 per share) and was granted an extension until June 22, 2026, to regain compliance.
• A new stock repurchase program authorizing up to $1 million of common stock was approved on February 20, 2026, to be in place until December 31, 2026; no shares have been repurchased under this plan as of the report date.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this as a challenging period for Silo Pharma, marked by continued significant losses, minimal revenue, and a setback in one of its key therapeutic programs (SPU-16). While capital raises provide liquidity, the Nasdaq compliance issue and the inherent volatility of its new crypto treasury strategy add substantial risk and uncertainty.

Positives

• Net loss decreased by 3.8% to $4,227,698 in 2025 from $4,392,880 in 2024, indicating a slight improvement in financial performance.
• Operating loss decreased by 9.0% to $4,280,662 in 2025 from $4,705,694 in 2024, reflecting reduced operating expenses.
• Working capital increased by 24% to $6,737,542 as of December 31, 2025, from $5,455,483 in 2024, improving the company's short-term financial health.
• Cash and cash equivalents increased by $842,901 to $4,748,700 as of December 31, 2025, providing stronger liquidity.
• Successful capital raises in May and October 2025, and June and July 2024, provided significant net proceeds, bolstering the company's financial resources.
• SPC-15 (PTSD/anxiety) is on track for IND submission in 2026, with preclinical data suggesting additional applications for eating disorders and anorexia, and enhanced efficacy when combined with an NMDA receptor antagonist.
• SP-26 (fibromyalgia/chronic pain) is in preclinical research, offering a potentially safer non-opioid alternative to traditional pain management.
• SPC-14 (Alzheimer's disease) has exclusive global development and commercialization rights and has shown efficacy in attenuating learned helplessness, preservative behavior, and hyponeophagia in preclinical studies.
• The new cryptocurrency treasury strategy is generating yield through staking activities, with $207 in staking income reported for 2025.
• Management believes current cash and short-term investments are sufficient to meet obligations for a minimum of twelve months from the filing date, mitigating going concern risks.

Negatives

• The company continues to report substantial net losses ($4,227,698 in 2025) and operating losses, indicating a lack of profitability.
• Revenues from operations remained minimal and stagnant at $72,102 for both 2025 and 2024, showing no significant progress in commercialization or revenue generation.
• Cost of revenues increased significantly from $5,838 in 2024 to $44,295 in 2025, primarily due to accelerated amortization of license fees following the termination of the UMB Master License Agreement.
• Other income, net, decreased by 83.1% to $52,964 in 2025, primarily due to a decrease in interest and dividend income and an increase in unrealized and impairment losses on crypto assets.
• The Master License Agreement for SPU-16 (Multiple Sclerosis) with UMB was terminated, and the company does not intend to extend the subsequent option agreement, suggesting a potential discontinuation or significant setback for this product candidate.
• The company received a Nasdaq notification for non-compliance with the minimum bid price requirement and has an extension until June 22, 2026, to regain compliance, posing a risk of delisting.
• An accumulated deficit of $19,492,389 as of December 31, 2025, highlights historical losses.
• The cryptocurrency treasury strategy introduces high price volatility, limited liquidity, and regulatory uncertainty, leading to unrealized losses ($64,608) and impairment losses ($39,916) on crypto assets in 2025.

Risks

• Limited operating history and no history of profitable operations, making future performance evaluation difficult.
• Requirement for additional financing in the future, which may cause dilution to stockholders, restrict operations, or necessitate relinquishing certain rights.
• Clinical drug development is a lengthy, expensive process with uncertain timelines and outcomes; product candidates may not receive regulatory approval or be commercialized.
• Future therapeutic candidates may be subject to controlled substance laws and regulations, with compliance costs or failure to comply adversely affecting business operations and financial condition.
• Significant breaches in compliance with U.S. and foreign laws and regulations governing controlled substances, or changes in these laws, may interrupt development activity or business continuity.
• Product candidates containing controlled substances (e.g., psilocybin) may generate public controversy and adverse publicity, negatively influencing their success.
• Ongoing obligations and continued regulatory review post-approval may result in significant additional expense or penalties.
• Dependence on patient enrollment in clinical trials; inability to enroll patients could materially adversely affect research and development efforts.
• Lack of necessary expertise, personnel, and resources to successfully commercialize therapies independently or with suitable collaborators.
• Commercial success of future therapeutic candidates depends on market access and acceptance by healthcare professionals, patients, and payors.
• Exposure to costly and damaging product liability claims, which may not be fully covered by insurance.
• Enacted and future legislation may increase the difficulty and cost of obtaining marketing approval and commercializing therapeutic candidates.
• Business operations and relationships may be subject to U.S. federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws, with potential for substantial penalties for non-compliance.
• Failure to obtain or maintain patents, licensing agreements, and other intellectual property could materially impact the ability to compete effectively.
• Patent prosecution is expensive and time-consuming, and issued patents may not provide adequate protection or may be challenged.
• Risk of involvement in lawsuits to protect or enforce intellectual property rights, which could be expensive, time-consuming, and unsuccessful.
• Third parties may initiate legal proceedings alleging infringement of their intellectual property rights.
• Noncompliance with procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies could reduce or eliminate patent protection.
• Claims by third parties asserting misappropriation of their intellectual property or claiming ownership of the company's intellectual property.
• Reliance on information technology; risk of service interruptions, data corruption, cyber-based attacks, or network security breaches.
• Difficulty in hiring and retaining key employees, including executive officers.
• Unfavorable global economic, business, or political conditions could adversely affect business, financial condition, or results of operations.
• The launch of central bank digital currencies (CBDCs) may adversely impact the digital asset business.
• Possibility that any digital asset acquired may be classified as a security, subjecting the company to additional regulation and materially impacting business operations.
• Risk of being deemed an investment company under the 1940 Act, which would make continuing segments of the business as currently contemplated impractical.
• Subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect business, financial condition, and results of operations.
• Cryptocurrency assets are less liquid than cash and cash equivalents and may not serve as a source of liquidity to the same extent.
• 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.
• Security breaches or cyberattacks on the company or its third-party service providers could lead to loss of acquired digital assets.
• Digital assets have historically experienced, and are expected to continue to experience, high price volatility, which may influence financial results and the market price of common stock.
• The availability of spot exchange-traded products (ETPs) for Bitcoin and other digital assets may adversely affect the market price of common stock.
• A temporary or permanent blockchain fork to a Digital Asset blockchain network could adversely affect the business.
• Staking introduces a risk of loss of digital assets due to validator misbehavior or inactivity.
• Staked digital assets may be inaccessible for a variable period of time, resulting in liquidity risk.
• Limited history in generating staking revenues from digital assets.
• Competition from other companies staking and utilizing digital assets in their treasury plans.
• May fail to develop and execute successful investment or trading strategies.
• Risk of making, or otherwise being subject to, trade errors.
• Failure to maintain listing of securities on Nasdaq or any stock exchange could adversely affect stock price and liquidity.
• Certificate of Incorporation grants the board of directors power to designate and issue preferred stock with rights, preferences, and privileges adverse to common stockholders.
• Never paid cash dividends and has no plans to pay cash dividends in the future.
• Future sales and issuances of securities could result in additional dilution of percentage ownership of stockholders and cause share price to fall.
• Risk of securities class action litigation.
• Financial reporting obligations of being a public company are expensive and time-consuming, diverting management's attention.
• Failure to maintain effective internal control over financial reporting could cause financial reports to be inaccurate.
• Nasdaq Capital Market may subsequently delist common stock if ongoing listing standards are not met.
• Market and economic conditions may negatively impact business, financial condition, and share price.

Future Outlook

The company aims for an Investigational New Drug (IND) submission for SPC-15 in 2026 and expects its research and development activities to increase as it develops existing and potentially acquires new product candidates. Management believes that current cash and short-term investments will provide sufficient liquidity for at least the next twelve months. The company intends to monitor its common stock bid price and may consider a reverse stock split to regain Nasdaq compliance by June 22, 2026. It also expects to continue operating outside the definition of an investment company. The company does not intend to extend the option agreement for SPU-16 with the University of Maryland, Baltimore.

Management Comments

• Our mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry.
• We believe our patented intranasal nose-to-brain drug dispersion technology provides a competitive advantage by increasing brain drug concentration, ensuring a faster onset of therapeutic effects with optimized safety.
• We believe SP-26's implant design provides a compelling non-opioid alternative to traditional pain management, improving dosage control compared to intravenous delivery.
• We believe our SPC-14 product has shown efficacy against luteinizing hormone (LH) in attenuating learned helplessness, preservative behavior and hyponeophagia (a measure of anxiety).
• We believe SPU-16 provides a competitive advantage by using homing peptides to reduce toxicity while enhancing therapeutic payload delivery.
• We believe that our current office space will be adequate for the foreseeable future.
• We believe that we maintain good relations with our employees and consultants.
• We believe cybersecurity is critical to advancing our technological advancements.
• We believe we are positioned to meet the requirements of the SEC.
• We believe that the Company has sufficient cash to meet its obligations for a minimum of twelve months from the date of this filing.

Industry Context

StockSavvy.ai notes that Silo Pharma operates in two highly dynamic and regulated sectors: biopharmaceuticals, particularly psychedelic-based therapies for CNS disorders, and the volatile digital asset market. The biopharma segment faces intense competition from established players and emerging technologies, with high R&D costs and lengthy regulatory processes. The company's entry into cryptocurrency treasury management in August 2025 positions it uniquely, but also exposes it to significant market volatility and evolving regulatory scrutiny, contrasting with traditional biopharma treasury strategies.

Comparison to Industry Standards

• Silo Pharma's focus on psychedelic-based therapies for PTSD, anxiety, fibromyalgia, and Alzheimer's aligns with a growing trend in neuroscience, where companies like Compass Pathways (CMPS) and MindMed (MNMN) are also exploring similar compounds. However, Silo Pharma's pipeline is still in preclinical stages for most candidates, whereas some competitors have advanced to later-stage clinical trials.
• The company's adoption of a cryptocurrency treasury strategy is unconventional for a biopharmaceutical firm, setting it apart from industry peers who typically maintain more conservative cash management. This strategy introduces a new layer of market risk not commonly seen in the sector.
• The reported net loss of $4.2 million is typical for a developmental-stage biopharmaceutical company with significant R&D expenses, but the minimal revenue generation ($72,102) highlights the early stage of its product commercialization efforts compared to revenue-generating biopharma companies.

Management Changes

Corporate Governance

Legal Proceedings

• The company is currently not aware of any legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on its business, financial condition, or operating results.

Stakeholder Impact

• Shareholders: Potential dilution from future equity offerings; risk of delisting from Nasdaq; volatility in stock price due to digital asset holdings and biopharma development risks; potential for appreciation if therapies succeed or crypto strategy performs well.
• Employees: Continued employment and incentive opportunities through stock options; potential for increased R&D activities.
• Customers/Patients: Potential for novel therapies for underserved conditions like PTSD, fibromyalgia, Alzheimer's, and MS, if product candidates successfully navigate clinical trials and regulatory approval.
• Licensors/Partners (Columbia, Medspray, UMB): Ongoing collaboration for SPC-15 and SPC-14; termination of SPU-16 license with UMB impacts that specific partnership.
• Creditors: Liquidity position improved by capital raises, but continued losses and need for future financing pose risks.

Next Steps

• Aiming for IND submission for SPC-15 in 2026.
• Conducting GLP-compliant pharmacokinetic and pharmacodynamic studies for SPC-15.
• Conducting IND-enabling GLP-compliant toxicology and toxicokinetics for SPC-15.
• Continuing preclinical research for SP-26, including initial animal studies evaluating dosage, time release, and absorption.
• Actively pursuing acquisition and/or development of intellectual property or technology rights to treat rare diseases.
• Monitoring common stock bid price and potentially implementing a reverse stock split to regain Nasdaq compliance by June 22, 2026.
• Stock repurchase program for up to $1 million in place until December 31, 2026.
• Columbia University and the Company will work towards developing a therapeutic treatment for patients suffering from Alzheimer's disease to posttraumatic stress disorder.

Key Dates

Recommendation

Silo Pharma presents a highly speculative investment. While the company is pursuing promising therapeutic areas, its biopharmaceutical pipeline is still in early preclinical or IND-enabling stages, meaning commercialization is years away and highly uncertain. The termination of the SPU-16 license and the intent not to extend the option agreement is a significant setback for one of its four candidates. Financially, the company continues to incur substantial net and operating losses with minimal revenue, indicating a lack of a sustainable business model in the near term. The Nasdaq minimum bid price non-compliance introduces a tangible delisting risk, which would severely impact liquidity and investor confidence. Furthermore, the adoption of a cryptocurrency treasury strategy, while potentially offering yield, introduces significant additional volatility and regulatory uncertainty, which is atypical and adds considerable risk for a biopharmaceutical company. The combination of early-stage, high-risk drug development, persistent financial losses, regulatory compliance issues, and exposure to volatile digital assets makes this a high-risk, speculative investment with more downside than upside in the short to medium term.

Keywords

Silo Pharma, biopharmaceutical, cryptocurrency, PTSD, stress-induced anxiety, fibromyalgia, Alzheimer's disease, multiple sclerosis, psychedelic medicine, ketamine, psilocybin, drug development, clinical trials, SEC filing, 10-K, Nasdaq, digital assets, Bitcoin, Ethereum, Solana, staking, intellectual property, regulatory compliance, financial results, stock repurchase, capital raise, preclinical studies, IND submission, corporate governance