10-K: BullFrog AI Faces Delisting Amidst Financial Strain

BullFrog AI Holdings, Inc. reported a net loss of $6.5 million for 2025 and faces potential delisting from Nasdaq due to non-compliance with equity and minimum bid price requirements, despite initial revenue generation and strategic collaborations.

Summary

• BullFrog AI Holdings, Inc. (BFRG) reported a net loss of $6,498,068 for the fiscal year ended December 31, 2025, an improvement from $6,993,647 in 2024.
• The company generated its first collaboration revenue of $116,670 in 2025, primarily from an agreement with Eleison Pharmaceuticals Inc., compared to no revenue in 2024.
• Operating expenses decreased by 9% to $6,616,528 in 2025 from $7,236,383 in 2024, driven by reductions in R&D and general & administrative costs.
• Cash and cash equivalents significantly decreased to $2,183,705 as of December 31, 2025, from $5,435,983 at the end of 2024.
• The company's accumulated deficit grew to $23,291,624 by December 31, 2025.
• BullFrog AI is not in compliance with Nasdaq's minimum stockholders' equity requirement ($2.5 million) and minimum bid price requirement ($1.00 per share), facing potential delisting.
• Stockholders approved a reverse stock split in October 2025 at a ratio of 1-to-2 to 1-to-15 to address the bid price deficiency.
• The company's proprietary AI/ML platform, bfLEAP, is used for drug discovery, preclinical, and clinical data analysis, with new solutions like BullFrog Data Networks and bfPREP launched.
• Strategic collaborations include a data use and technology partnership with the Lieber Institute for Brain Development (LIBD) for brain data analysis and a joint marketing arrangement with Sygnature Discovery.
• The company holds exclusive worldwide licenses for several drug candidates, including siRNA targeting Beta2-spectrin (preclinical for liver diseases) and improved Mebendazole formulations (Phase I completed for glioblastoma, preclinical for prodrug BF-223).
• Material weaknesses in internal controls over financial reporting identified in 2023 and 2024 were remediated as of December 31, 2025.
• The company's independent registered public accounting firm included an explanatory paragraph regarding substantial doubt about its ability to continue as a going concern.
• As of December 31, 2025, the company had 9 full-time employees and 8 part-time employees, advisors, and consultants.
• Vininder Singh, CEO, beneficially owns approximately 19.51% of the company's common stock as of March 1, 2026.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this as a highly concerning report due to severe liquidity issues, explicit going concern warnings, and immediate Nasdaq delisting threats. While there are positive developments in technology and collaborations, the financial instability overshadows these achievements, indicating significant operational and investment risk.

Positives

• Generated first collaboration revenue of $116,670 in 2025, marking a step towards commercialization.
• Reduced net loss by approximately $495,000 in 2025 compared to 2024, indicating some cost management or operational efficiency improvements.
• Successfully remediated previously identified material weaknesses in internal controls over financial reporting as of December 31, 2025.
• Secured strategic collaborations with Eleison Pharmaceuticals Inc. and Sygnature Discovery, expanding market reach and validating platform utility.
• Positive preclinical study results for BF-223, a novel prodrug of mebendazole for glioblastoma, showing improved survival time and tumor growth reduction compared to placebo.
• Continued development and enhancement of the bfLEAP AI/ML platform, including new solutions like BullFrog Data Networks and bfPREP, positioning for advanced data analytics.
• Stockholders approved a reverse stock split, providing a mechanism to potentially regain Nasdaq's minimum bid price compliance.
• Maintained a strategic data and commercialization partnership with the Lieber Institute for Brain Development, leveraging extensive brain data for drug discovery.

Negatives

• Incurred a significant net loss of $6,498,068 in 2025, contributing to a growing accumulated deficit of $23,291,624.
• Cash and cash equivalents decreased substantially from $5.4 million in 2024 to $2.2 million in 2025, indicating rapid cash burn.
• The company's cash position is not sufficient to fund planned operations for at least a year, raising substantial doubt about its ability to continue as a going concern.
• Received notice from Nasdaq regarding non-compliance with the minimum stockholders' equity requirement ($2.5 million) and failed to meet the extension terms by February 17, 2026.
• Received notice from Nasdaq regarding non-compliance with the minimum bid price requirement ($1.00 per share) as of February 10, 2026.
• Significant reliance on future financing, with no assurance that sufficient capital will be available on acceptable terms or at all.
• The ATM Agreement capacity is currently limited to approximately $1.1 million due to public float restrictions, hindering immediate capital raising efforts.
• Has not yet conducted clinical trials on any pharmaceutical drugs or had its platform identify a drug candidate that received regulatory approval for commercialization.
• Minimum annual royalty payments for the JHU-APL license are $300,000 for 2024 and beyond, which are significant for a company with limited revenue.

Risks

• The company has a limited operating history and has incurred significant losses, raising substantial doubt about its ability to continue as a going concern.
• Future sales or issuances of common stock could depress the trading price and impair the ability to raise capital.
• Inability to maintain Nasdaq listing due to non-compliance with stockholders' equity and minimum bid price requirements could adversely affect stock price, liquidity, and financing ability.
• Failure to attract and retain key management, scientific personnel, and advisors could hinder business objectives.
• The development of technology, products, and services is highly competitive, with many competitors having greater financial and technical resources.
• Intellectual property rights may not be sufficiently broad or adequately protected, leading to potential infringement claims or competitive disadvantages.
• Reliance on third-party intellectual property licenses means future availability on favorable terms is not assured.
• New product development is lengthy, expensive, and complex, with no assurance of successful commercialization or regulatory approval.
• Inability to conduct necessary clinical trials or trials being halted by the FDA could significantly reduce the value of products.
• The business model relies on acquiring rights to failed drugs, but there is no guarantee of successful acquisition or rescue through AI/ML analysis.
• Investment in early-stage experimental technologies carries a high risk of failure.
• Dependence on collaborative agreements with third parties exposes the company to risks related to partner viability and performance.
• Significant risks related to the availability, cost, and performance of computational infrastructure for AI models, including supply chain constraints and rising costs.
• Subject to evolving laws and regulations governing the use of artificial intelligence, which could impose compliance obligations and adverse effects.
• Unfavorable global economic conditions, geopolitical events, and inflationary pressures could adversely affect business and ability to raise capital.
• Cyberattacks or breaches of information technology systems could lead to data loss, operational disruptions, and liability.

Future Outlook

The company plans to continue evolving and improving its bfLEAP AI/ML platform, either in-house or with development partners. It aims to generate future revenue through strategic relationships with biopharma companies, structured as a combination of cash fees, equity, or other consideration. A key part of the strategy involves acquiring rights to drugs at various stages of development, using AI/ML to advance them, and then divesting and monetizing these assets, preferably within approximately 30 months. The company also intends to secure rights to other proprietary datasets and repeat its strategy of analyzing rich datasets to identify revenue-generating strategic partnership deals with biopharmaceutical companies. A new scenario-based decision engine solution is planned for launch in late March 2026.

Management Comments

• "Our objective is to utilize bfLEAP, our AI/ML platform, with a precision medicine approach toward drug development with biopharmaceutical collaborators, as well as with our own internal clinical development programs."
• "We believe the bfLEAP platform is ideally suited for evaluating pre-clinical and clinical trial data generated in translational research and clinical trial settings in order to lead to faster, less expensive drug approvals."
• "Our ultimate objective is to utilize bfLEAP to enable the success of ongoing third-party clinical trials or rescue late-stage failed drugs (i.e., Phase II or Phase III clinical trial failures) for in-house development and divestiture."
• "We intend to continue to evolve and improve bfLEAP, either in-house or with development partners like JHU-APL."
• "The ability to continue as a going concern is dependent upon us utilizing the financing facilities available to us and/or obtaining necessary additional financing and/or revenues to meet our obligations arising from normal business operations when they become due."
• "We intend to monitor the closing bid price of its Common Stock and assess potential options to regain compliance with Nasdaq's Listing Rules."

Industry Context

StockSavvy.ai notes that BullFrog AI operates within the rapidly growing but highly competitive intersection of artificial intelligence and biotechnology. The company's focus on 'drug rescue' and precision medicine using AI/ML aligns with broader industry trends seeking to de-risk and accelerate drug development, which is notoriously expensive and prone to failure. The estimated $47.1 billion market opportunity for failed drugs highlights a significant niche, but also the challenge of identifying and successfully re-developing such assets. The increasing regulatory scrutiny on AI in healthcare, as evidenced by FDA guidance and executive orders, indicates a maturing landscape that will require robust compliance and validation from AI-driven drug developers.

Comparison to Industry Standards

• BullFrog AI's bfLEAP platform, derived from Johns Hopkins University Applied Physics Laboratory technology, claims superiority over 10 popular clustering algorithms in speed and accuracy of prediction, as published in DeepAI.org in August 2021. This suggests a potential competitive edge in data analysis compared to general industry offerings.
• The company's strategy of 'drug rescue' for late-stage failed drugs (Phase II or III) is a distinct approach compared to many traditional biopharma companies that focus on de novo discovery or early-stage licensing. This could offer a faster path to market if successful, but also carries the risk of inheriting complex biological challenges.
• While the company has licensed drug candidates (siRNA, Mebendazole prodrugs), none have yet reached regulatory approval or commercialization, placing it behind more established biopharmaceutical companies like Pfizer or Merck, or even mid-cap biotechs with approved products.
• The company's revenue generation from contract services ($116,670 in 2025) is minimal compared to the multi-million or billion-dollar revenues of established players in the pharmaceutical AI/ML space or contract research organizations (CROs) like IQVIA or Charles River Laboratories, which offer extensive data analytics services.
• The company's financial position, with an accumulated deficit of over $23 million and insufficient cash for a year of operations, is typical of early-stage biotech companies but contrasts sharply with the robust balance sheets of industry leaders, highlighting significant financial risk.

Management Changes

Corporate Governance

Legal Proceedings

• The company is not currently a party to any legal or administrative proceedings.

Related Party Transactions

• In October 2022, an exchange agreement with an investor converted 734,493 shares of common stock into 73,449 shares of Series A Convertible Preferred Stock. This preferred stock is non-voting and converts to common stock at a 10:1 ratio, subject to a 4.99% blocker to prevent the investor from owning more than 4.99% of outstanding common stock upon conversion.

Stakeholder Impact

• **Shareholders**: Face significant risk of dilution from future capital raises and potential loss of investment due to the going concern warning and Nasdaq delisting threats. The approved reverse stock split could temporarily boost share price but doesn't address underlying financial health.
• **Employees**: The company's financial instability and going concern warning could impact job security and future compensation, despite competitive compensation and benefits programs.
• **Customers/Partners**: Existing and potential partners may face uncertainty regarding the company's long-term viability, potentially affecting the continuity of collaborations and services.
• **Creditors**: The going concern warning indicates increased risk for creditors, as the company's ability to meet its obligations is in doubt without additional financing.

Next Steps

• Present additional details of the compliance plan and provide an update on efforts to regain compliance at a Nasdaq Hearings Panel.
• Request additional time from the Nasdaq Hearings Panel to complete steps of the compliance plan and regain compliance with all applicable Nasdaq Listing Rules.
• Monitor the closing bid price of common stock and assess potential options to regain compliance with Nasdaq's Minimum Bid Price Requirement by August 10, 2026.
• Formulate a strategy to find a partner to conduct additional clinical trials for the improved Mebendazole formulation.
• Formulate a strategy for initiating IND-enabling studies on BF-223 and conduct outreach to identify partners for licensing or development.
• Continue to evolve and improve the bfLEAP AI/ML platform, potentially with development partners.
• Launch a new scenario-based decision engine solution in late March 2026.
• Seek additional capital through various avenues including revenues from services, licensing agreements, collaborative arrangements, and/or the selling of equity securities or entry into debt transactions.

Key Dates

Recommendation

The company faces immediate and severe financial distress, evidenced by a going concern warning from its auditor, rapidly depleting cash reserves, and non-compliance with multiple Nasdaq listing requirements, including both stockholders' equity and minimum bid price. While the company has promising AI technology and strategic collaborations, its ability to fund operations and execute its business plan is highly uncertain. The significant risk of delisting, coupled with the need for substantial dilutive capital raises, makes the stock a strong sell for seasoned investors, as the downside risk is substantial and immediate.

Keywords

AI in drug discovery, Machine learning in healthcare, Biotechnology, Drug development, Precision medicine, Glioblastoma, Hepatocellular carcinoma, Nasdaq delisting, Going concern, SEC filing, bfLEAP, Oncology, Rare disease, Capital raise