BullFrog AI Holdings, Inc.

BullFrog AI Holdings, Inc. operates in the biopharmaceutical industry, focusing on the application of Artificial Intelligence and Machine Learning (AI/ML) to advance medicine development ¹. The company's core business model is to improve the success and efficiency of drug development through strategic acquisitions of clinical-stage and failed drugs for in-house development, or through strategic partnerships and collaborations with biopharmaceutical companies ². The company aims to generate revenue from contract services, collaborative arrangements, and the acquisition and subsequent divestment of drug rights ³.

The company's primary customer segments include biopharmaceutical companies and other organizations facing challenges in data analysis throughout the drug development process ⁴. The business model involves a mix of transactional income from contract services and success fees from collaborative arrangements, potentially including equity or intellectual property rights ⁵. For acquired drug rights, revenue generation is tied to upfront payments, milestone payments based on clinical success, and royalties on product sales ⁶.

BullFrog AI's product and service lines are centered around its proprietary AI/ML platform, bfLEAP™. This platform is an analytical AI/ML tool derived from technology developed at The Johns Hopkins University Applied Physics Laboratory (JHU-APL) ⁷. bfLEAP™ is designed to synthesize disparate, high-dimensional data to provide precise, multi-dimensional understanding for researchers and clinicians, aiming to increase the probability of success and decrease the time and cost in therapeutics development ⁸. The platform utilizes both supervised and unsupervised machine learning, capable of handling highly imbalanced datasets to identify combinations of factors associated with outcomes of interest ⁹. The company also offers BullFrog Data Networks™, an AI-powered bioinformatics solution for integrating and analyzing multi-omics, clinical, and real-world biomedical data to accelerate drug discovery, target identification, and clinical trial design ¹⁰. Additionally, bfPREP™ is an AI-powered data preparation platform that cleans, standardizes, and harmonizes fragmented biomedical datasets for analysis ¹¹. The company has also licensed specific drug candidates: an siRNA targeting Beta2-spectrin for hepatocellular carcinoma and other liver diseases, currently in preclinical stages ¹², and an improved formulation of Mebendazole for glioblastoma, which has completed a Phase I clinical trial ¹³. Furthermore, N-substituted prodrugs of mebendazole with enhanced solubility and bioavailability are licensed from JHU and IOCB, with one compound, BF-223, showing effectiveness in a preclinical glioblastoma model ¹⁴.

For the fiscal year ended December 31, 2025, BullFrog AI Holdings, Inc. recognized collaboration revenue of approximately $117,000 ¹⁵ and incurred a cost of collaboration revenue of approximately $95,000 ¹⁶, resulting in a gross profit of $21,892 ¹⁷. Total operating expenses for the year were $6,616,528 ¹⁸, leading to a loss from operations of $(6,594,636) ¹⁹. The net loss for the year was $(6,498,068) ²⁰, with a diluted EPS of $(0.63) ²¹. As of December 31, 2025, the company had cash and cash equivalents of $2,183,705 ²², including restricted cash of $105,000 ²³. Total liabilities were $672,022 ²⁴, and total stockholders' equity was $2,136,329 ²⁵. The accumulated deficit stood at $(23,291,624) ²⁶. Net cash used in operating activities was $(5,522,265) ²⁷.

Comparing the fiscal year 2025 to 2024, collaboration revenue increased from $0 in 2024 to $116,670 in 2025 ²⁸. Cost of collaboration revenue also increased from $0 in 2024 to $94,778 in 2025 ²⁹. Research and development expenses decreased by 19% from $2,223,265 in 2024 to $1,799,738 in 2025 ³⁰, primarily due to a reduction in personnel costs and the allocation of certain personnel costs to cost of revenue ³¹. General and administrative expenses decreased by 4% from $5,013,118 in 2024 to $4,816,790 in 2025 ³², mainly due to reductions in director and officer insurance policy premiums and recruiting fees, partially offset by an increase in noncash stock-based compensation expense ³³. Interest expense decreased by approximately $12,000 ³⁴, while interest income decreased by approximately $159,000 ³⁵ due to a decrease in average cash balances. Net cash used in operating activities decreased by approximately $88,000 ³⁶ in 2025 compared to 2024, primarily due to decreased operating costs, partially offset by timing and payment of vendor invoices ³⁷. Net cash provided by financing activities decreased from $8,421,502 in 2024 to $2,374,987 in 2025 ³⁸, mainly due to proceeds from offerings and warrant exercises in 2024 not being fully offset by ATM sales in 2025 ³⁹.

During the reported period, the company entered into a collaboration agreement with Eleison Pharmaceuticals Inc. in February 2025 ⁴⁰, which was completed in the third quarter of 2025 ⁴¹. In June 2025, a strategic collaboration agreement was established with Sygnature Discovery for a joint marketing arrangement of the BullFrog Data Networks™ platform ⁴². The company also made a payment of $75,000 in June 2025 as part of an amendment to its license agreement with JHU-APL ⁴³. In April 2025, the company entered into an At-The-Market (ATM) Sales Agreement with BTIG, LLC, to sell up to $20 million of common stock ⁴⁴. Through December 31, 2025, approximately $2.6 million of net proceeds were received from the sale of 1,686,511 shares of common stock under this agreement ⁴⁵. In September 2025, a purchase agreement was made with Lincoln Park Capital Fund, LLC, for the potential purchase of up to $10.0 million of common stock over a 36-month period ⁴⁶, with 147,682 shares of common stock valued at approximately $207,000 issued as a commitment fee ⁴⁷. Stockholders approved an amendment in October 2025 to increase shares available for grant under the 2022 Equity Incentive Plan by 750,000 ⁴⁸. The company received a notice from Nasdaq on August 21, 2025, regarding non-compliance with the minimum stockholders' equity requirement of $2,500,000 ⁴⁹, and an extension was granted until February 17, 2026 ⁵⁰. A further notice was received on February 19, 2026, indicating non-compliance with the extension terms ⁵¹. Additionally, on February 10, 2026, Nasdaq notified the company of non-compliance with the Minimum Bid Price Requirement of $1.00 per share ⁵², providing a compliance period until August 10, 2026 ⁵³.

BullFrog AI Holdings, Inc. has not provided formal revenue, margin, or EPS guidance for the upcoming period.

The company plans to achieve its business objectives by enabling the successful discovery and/or development of drugs and biologics using a precision medicine approach via its proprietary artificial intelligence platform, bfLEAP™ ⁵⁴. This strategy includes strategic acquisitions of current clinical stage and failed drugs for in-house development, or through strategic partnerships with biopharmaceutical industry companies ⁵⁵. The company aims to leverage its bfLEAP™ platform to determine multi-factorial profiles for patients who would best respond to drugs, rapidly conduct clinical trials to validate these findings, and then divest the rescued drug assets with new information to larger pharmaceutical companies ⁵⁶. The company intends to continue evolving its intellectual property, analytical platform, and technologies, build a large portfolio of drug candidates, and implement a model that reduces risk and increases the frequency of cash flow from rescued drugs ⁵⁷. This strategy will include strategic partnerships, collaborations, and relationships along the entire drug development value chain, as well as acquisitions of the rights to developing failed drugs and possibly the underlying companies ⁵⁸.

A key growth area is the expansion of its AI/ML platform, bfLEAP™, which was enhanced through an exclusive, world-wide, royalty-bearing license from JHU-APL in July 2022 ⁵⁹, superseding a previous 2018 agreement ⁶⁰. This license provides additional intellectual property rights including patents, copyrights, and know-how ⁶¹. The company also gained access to certain improvements, including additional patents and know-how, through an amendment to the July 2022 license agreement in May 2023, in exchange for a series of payments totaling $275,000 ⁶², with remaining payments of $75,000 and $50,000 due in 2026 and 2027, respectively ⁶³. The company is planning to launch a new scenario-based decision engine solution in late March 2026 ⁶⁴, which is an AI-powered analytical environment designed to support complex decision-making in drug development and biomedical research ⁶⁵. This platform will apply advanced modeling and simulation techniques to evaluate multiple development scenarios, helping researchers and executives explore potential outcomes of different clinical, regulatory, and commercialization strategies ⁶⁶.

Another growth vector involves strategic data and commercialization agreements, such as the partnership with the Lieber Institute for Brain Development (LIBD) ⁶⁷. This partnership allows the company to leverage its bfLEAP™ platform to mine LIBD’s comprehensive brain data to identify previously unrecognized relationships between genes and pathways in the brain and the development of neurologic and psychiatric disorders, facilitating the development of more effective treatments ⁶⁸. The collaboration proceeds in two stages, with the first involving unsupervised construction of graphical models to reveal relationships between brain diseases and genomic/biologic attributes, aiming to identify new biomarkers and drug targets ⁶⁹. The second stage will create disease-specific models to identify genes and pathways within these disorders ⁷⁰. The company has a worldwide, royalty-bearing exclusive license from LIBD for Licensed Products in the application of machine learning and artificial intelligence for research and development in drug development ⁷¹.

The company anticipates that its research and development costs could become significant over time as it executes its business plan and begins conducting preclinical research and development activities directed at securing development partners and filing investigational new drug (IND) applications for its licensed drug development programs, as well as under strategic partnerships and for other drug development programs it may acquire ⁷². The company expects its general and administrative expenses to increase in the future to support its service offerings and clinical and preclinical research and development activities associated with strategic partnering and collaborations ⁷³.

Regarding capital allocation, the company has an At-The-Market (ATM) Sales Agreement with BTIG, LLC, under which it may offer and sell shares of common stock up to an aggregate offering price of $20 million ⁷⁴. As of the filing date, approximately $16.4 million of capacity remains available under the ATM Agreement ⁷⁵, though the amount permitted to be raised in any 12-month period is currently limited to approximately $1.1 million based on its public float ⁷⁶. The company also has a purchase agreement with Lincoln Park Capital Fund, LLC, committing Lincoln Park to purchase up to $10.0 million of common stock over a 36-month period ⁷⁷. In January 2026, the company received approximately $218,000 of net proceeds from the sale of 270,000 shares of common stock under this facility ⁷⁸. The company does not currently intend to pay dividends on its common stock ⁷⁹.

The company has explicitly flagged several structural headwinds and execution risks. It has incurred significant operating losses since inception and expects to incur losses for the foreseeable future, potentially never achieving profitability ⁸⁰. The company will continue to require additional capital for the foreseeable future, and if unable to raise additional capital when needed, it may be forced to delay, reduce, or eliminate drug acquisition efforts ⁸¹. The development of its technology, products, and services is highly competitive, with many competitors having significantly greater financial resources and expertise ⁸². The company faces risks related to the availability, cost, and performance of computational infrastructure required to train and deploy AI models, as the global supply of specialized resources is constrained and costs have risen ⁸³. Export controls, trade restrictions, and national security regulations may limit the company's ability to operate in certain markets and access critical technologies ⁸⁴. The capital requirements for AI development are substantial and increasing, and there is no assurance that adequate financing will be available on acceptable terms ⁸⁵. The company may be subject to new laws and regulations governing the use of artificial intelligence in healthcare, which could have a material adverse effect on its business ⁸⁶. Unfavorable global economic conditions, including geopolitical events, inflationary pressures, and interest rate volatility, could adversely affect the business ⁸⁷.

Investing in BullFrog AI Holdings, Inc. securities involves a high degree of risk, as the company has a limited operating history and has incurred significant losses since inception, raising substantial doubt about its ability to continue as a going concern ⁸⁸. The company's ability to secure additional capital is critical, as its existing cash and cash equivalents of approximately $2.3 million ⁸⁹ as of December 31, 2025, are not sufficient to fund planned operations for at least a year beyond the filing date ⁹⁰, and failure to raise funds could force delays or elimination of drug acquisition efforts ⁹¹. The company faces intense competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies, many of which possess significantly greater financial resources and expertise ⁹². There is a risk that the company's AI/ML technology may not uncover actionable insights or that sufficient clinical data may not be accessible to lead to successful projects, clinical trials, or products ⁹³. The company is also subject to evolving regulatory risks, including potential new federal and state laws governing AI in healthcare, as evidenced by President Trump's AI-related Executive Orders in July 2025 and December 2025, and FDA draft guidance and guiding principles issued in January 2025 and January 2026, respectively ⁹⁴. Unfavorable global economic conditions, including geopolitical events such as military operations in the Middle East and the Russian invasion of Ukraine, inflationary pressures, and interest rate volatility, could adversely affect the business, particularly given that portions of future clinical trials may be conducted outside the United States, making them costlier if the U.S. dollar weakens ⁹⁵. Cybersecurity threats, including potential cyberattacks on the company's information technology systems or those of third-party vendors, pose a risk of data theft, loss, or disruption, which could delay regulatory approval efforts and increase costs ⁹⁶. The company is also at risk of delisting from Nasdaq due to non-compliance with the minimum stockholders' equity requirement of $2,500,000 ⁹⁷ and the Minimum Bid Price Requirement of $1.00 per share ⁹⁸, which could adversely affect its stock price, liquidity, and ability to raise capital ⁹⁹.

Management's message to shareholders conveys a commitment to leveraging advanced Artificial Intelligence and Machine Learning (AI/ML) to address the high cost and failure rates in therapeutics development, with a focus on increasing the probability of success and decreasing time and cost. The company explicitly states its objective to utilize its bfLEAP™ AI/ML platform with a precision medicine approach toward drug development with biopharmaceutical collaborators, as well as with its own internal clinical development programs, aiming for faster, less expensive drug approvals. Management acknowledges the company's negative cash flows from operations and accumulated deficit of approximately $23.3 million ¹⁰⁰ as of December 31, 2025, and states that its cash and cash equivalents of approximately $2.3 million ¹⁰¹ are not sufficient to fund planned operations for at least a year beyond the filing date, which raises substantial doubt about its ability to continue as a going concern. The company intends to secure additional capital through revenues from services, licensing agreements, collaborative arrangements, and the selling of equity securities or debt transactions, including utilizing its At-The-Market (ATM) Sales Agreement and purchase agreement with Lincoln Park Capital Fund, LLC. Management also addresses the Nasdaq listing compliance issues, noting the receipt of notices regarding non-compliance with the minimum stockholders' equity requirement of $2,500,000 ¹⁰² and the Minimum Bid Price Requirement of $1.00 per share ¹⁰³, and states its intention to monitor the bid price and assess potential options, including a reverse stock split, to regain compliance. The three strategic priorities emphasized are: generating revenue through strategic relationships with biopharma companies via fee-for-service and collaborative arrangements, acquiring rights to drugs at various stages of development and using proprietary AI/ML technology to advance their development for monetization, and continuously evolving and improving the bfLEAP™ AI/ML platform, either in-house or with development partners.