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BullFrog AI Holdings, Inc.

BullFrog AI Holdings, Inc.BFRG财报

Nasdaq · 医疗保健 · 药物制剂

Bullfrog Productions Limited was a British video game developer based in Guildford, England. Founded in 1987 by Peter Molyneux and Les Edgar, the company gained recognition in 1989 for their third release, Populous, and is also well known for titles such as Theme Park, Theme Hospital, Magic Carpet, Syndicate and Dungeon Keeper. Bullfrog's name was derived from an ornament in the offices of Edgar's and Molyneux's other enterprise, Taurus Impact Systems, Bullfrog's precursor where Molyneux and ...

What changed in BullFrog AI Holdings, Inc.'s 10-K — 2024 vs 2025

Top changes in BullFrog AI Holdings, Inc.'s 2025 10-K

242 paragraphs added · 200 removed · 169 edited across 4 sections

Item 1. Business

Business — how the company describes what it does

123 edited+35 added−18 removed109 unchanged
There is often a high degree of similarity among closely related therapeutics in a candidate pool - bfLEAP™ is able to harmonize disparate data streams for a more nuanced understanding of each candidate’s characteristics/potency. ● Pre-Clinical Data - Large-scale, multivariate analysis of pre-clinical and early-stage clinical data sets.
There is often a high degree of similarity among closely related therapeutics in a candidate pool; bfLEAP™ is able to harmonize disparate data streams for a more nuanced understanding of each candidate’s characteristics and potency. ● Pre-Clinical Data – Large-scale, multivariate analysis of pre-clinical and early-stage clinical data sets.
This formulation shows potent activity in animal models with different types of cancer, and has been evaluated in a Phase I clinical trial in patients with high-grade glioma (NCT01729260). The trial, an open-label dose-escalation study, assessed the safety of the improved formulation with adjuvant temozolomide in 24 patients with newly diagnosed gliomas.
This formulation shows potent activity in animal models with different types of cancer, and has been evaluated in a Phase I clinical trial in patients with high-grade glioma (NCT01729260). The trial, an open-label dose-escalation study, assessed the safety of the improved formulation with adjuvant temozolomide in 24 patients with newly diagnosed gliomas.
Investigators observed no dose-limiting toxicity in patients receiving all but the highest tested dose (200mg/kg/day). Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced dose-limiting toxicity, all of which were reversed by decreasing or eliminating the dose given. There were no serious adverse events attributed to mebendazole at any dose during the trial.
Investigators observed no dose-limiting toxicity in patients receiving all but the highest tested dose (200mg/kg/day). Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced dose-limiting toxicity, all of which were reversed by decreasing or eliminating the dose given. There were no serious adverse events attributed to mebendazole at any dose during the trial.
Animals treated with BF-223 had an average survival time of 27.9 days compared with 27.3 days for mice treated with BF-222 and 23.4 days for mice given placebo. Mice treated with BF-223 were administered 80% of the dose that mice treated with BF-222 received, and improved outcomes for both treatment groups were statistically significant compared to placebo.
Animals treated with BF-223 had an average survival time of 27.9 days compared with 27.3 days for mice treated with BF-222 and 23.4 days for mice given the placebo. Mice treated with BF-223 were administered 80% of the dose that mice treated with BF-222 received, and improved outcomes for both treatment groups were statistically significant compared to the placebo.
Since data quality is a problem that exists in the healthcare industry, we see these as major differentiators. The ability to make predictions, find relationships and patterns and anomalies in extremely large complex data sets has been demonstrated by the JHU-APL in other applications and sectors.
Since data quality is a problem that exists in the healthcare industry, we see these as major differentiators. The ability to make predictions and find relationships, patterns, and anomalies in extremely large, complex data sets has been demonstrated by JHU-APL in other applications and sectors.
Second, it is adept at processing and analyzing incomplete data and making predictions that we do not believe other technologies are capable of doing. Third, bfLEAP has the ability to extract the most important features for analysis out of extremely large complex data sets using unsupervised machine learning algorithms, thereby greatly simplifying complex problems.
Second, it is adept at processing and analyzing incomplete data and making predictions that we do not believe other technologies are capable of doing. Third, bfLEAP TM has the ability to extract the most important features for analysis out of extremely large, complex data sets using unsupervised machine learning algorithms, thereby greatly simplifying complex problems.
The new license also contains tiered sub licensing fees that start at 50% and reduce to 25% based on revenues. We believe the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical and clinical data sets, such as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical trial settings.
The license also contains tiered sub licensing fees that start at 50% and reduce to 25% based on revenues. We believe the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical and clinical data sets, such as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical trial settings.
Our platform technology, named, bfLEAP™, is an analytical AI/ML platform derived from technology developed at The Johns Hopkins University Applied Physics Laboratory (“JHU-APL”), which is able to surmount the challenges of scalability and flexibility currently hindering researchers and clinicians by providing a more precise 1 , multi-dimensional understanding of their data.
Our platform technology, bfLEAP™, is an analytical AI/ML platform derived from technology developed at The Johns Hopkins University Applied Physics Laboratory (“JHU-APL”), which is able to surmount the challenges of scalability and flexibility currently hindering researchers and clinicians by providing a more precise 1 , multi-dimensional understanding of their data.
The new license also contains tiered sub licensing fees that start at 50% and reduce to 25% based on revenues. In addition, under the new license agreement, the minimum annual royalty payments are $30,000 for 2022, $80,000 for 2023, and $300,000 per year for 2024 and beyond, all of which are creditable by royalties.
The license also contains tiered sub licensing fees that start at 50% and reduce to 25% based on revenues. In addition, under the 2022 License Agreement, the minimum annual royalty payments are $30,000 for 2022, $80,000 for 2023, and $300,000 per year for 2024 and beyond, all of which are creditable by royalties.
Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product.
Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. 19 Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product.
Algorithms used in the bfLEAP™ platform are designed to handle highly imbalanced data sets to successfully identify combinations of factors that are associated with outcomes of interest. Together with our strategic partners and collaborators, our primary goal is to improve the odds of success at any stage of pre-clinical and clinical therapeutics development.
Algorithms used in the bfLEAP™ platform are designed to handle highly imbalanced data sets to successfully identify combinations of factors that are associated with outcomes of interest. 5 Together with our strategic partners and collaborators, our primary goal is to improve the odds of success at any stage of pre-clinical and clinical therapeutics development.
In addition, animals treated with equivalent doses of BF-222 and BF-223 showed comparable and significant reduction in tumor growth compared to control animals during the study. 16 Competition The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products.
In addition, animals treated with equivalent doses of BF-222 and BF-223 showed comparable and significant reduction in tumor growth compared to control animals during the study. Competition The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products.
All statements made in any of our securities filings, including all forward-looking statements or information, are made as of the date of the document in which the statement is included unless otherwise specified, and we do not assume or undertake any obligation to update any of those statements or documents unless we are required to do so by law.
All statements made in any of our securities filings, including all forward-looking statements or information, are made as of the date of the document in which the statement is included unless otherwise specified, and we do not assume or undertake any obligation to update any of those statements or documents unless we are required to do so by law. 23
Third-party payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all of FDA-approved drugs for a particular indication. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.
Third-party payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drugs for a particular indication. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.
We believe the weakness of the industry is the quality of the data and we believe bfLEAP provides several competitive advantages, that will position the Company for success, First, bfLEAP is highly scalable and can process data from small to extremely large complex data sets without the need for additional code being developed.
We believe the weakness of the industry is the quality of the data and we believe bfLEAP TM provides several competitive advantages, that will position the Company for success, First, bfLEAP TM is highly scalable and can process data from small to extremely large, complex data sets without the need for additional code being developed.
The Company will also reimburse GWU for previously incurred and ongoing patent costs. The sublicense and assignment fee amounts decline as the Company advances the clinical development of the licensed technology. The license agreement also contains milestone payments for clinical development through the approval of a New Drug Application (“NDA”) and commercialization.
We will also reimburse GWU for previously incurred and ongoing patent costs. The sublicense and assignment fee amounts decline as the Company advances the clinical development of the licensed technology. The license agreement also contains milestone payments for clinical development through the approval of a New Drug Application (“NDA”) and commercialization.
FDA must determine if the drug candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request. If a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with the FDA, and the FDA may review sections of the NDA before the application is complete.
FDA must determine if the drug candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request. 20 If a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with the FDA, and the FDA may review sections of the NDA before the application is complete.
Data networks created from this process generate insights that allow researchers to accelerate drug discovery and development and increase the odds of technical and regulatory success. In February 2025, we entered into a collaboration agreement with Eleison Pharmaceuticals Inc.
We believe that data networks created from this process generate insights that allow researchers to accelerate drug discovery and development and increase the odds of technical and regulatory success. In February 2025, we entered into a collaboration agreement with Eleison Pharmaceuticals Inc.
In consideration of the rights granted to the Company under the license agreement, JHU received a staggered upfront license fee of $250,000, with the first $50,000 paid in 2022 and the remaining balance of $200,000 paid in 2023. The Company also reimbursed JHU for previously incurred and ongoing patent costs.
In consideration of the rights granted to us under the license agreement, JHU received a staggered upfront license fee of $250,000, with the first $50,000 paid in 2022 and the remaining balance of $200,000 paid in 2023. The Company also reimbursed JHU for previously incurred and ongoing patent costs.
The FDA cannot approve an ANDA for a generic drug that includes the change during the period of exclusivity. 20 Patent Term Extension After NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension.
The FDA cannot approve an ANDA for a generic drug that includes the change during the period of exclusivity. Patent Term Extension After NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension.
Previous success of a particular candidate in trials combined with our precision medicine approach to clinical trial design using our bfLEAP platform, will de-risk the development process and improve the chances for success.
Previous success of a particular candidate in trials combined with our precision medicine approach to clinical trial design using our bfLEAP TM platform, will de-risk the development process and improve the chances for success.
Bullfrog Data Networks™ The Company’s Bullfrog Data Networks™ solution incorporates publicly available, proprietary, and custom data sources to generate novel insights toward target identification and validation, understanding mechanism of action, clinical trial optimization, drug repurposing, and more.
BullFrog Data Networks™ The BullFrog Data Networks™ solution incorporates publicly available, proprietary, and custom data sources to generate novel insights toward target identification and validation, understanding mechanism of action, clinical trial optimization, drug repurposing, and more.
Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. 19 Adverse event reporting and submission of periodic reports are required following FDA approval of an NDA.
Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. Adverse event reporting and submission of periodic reports are required following FDA approval of an NDA.
The Commercial Agreement, generally, may be terminated at any time by either the Company or LIBD if either party defaults or breaches any material term of the agreement or files for protection under bankruptcy laws, makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver, trustee, or similar agent over its property.
The Commercial Agreement, generally, may be terminated at any time by either us or LIBD if either party defaults or breaches any material term of the agreement or files for protection under bankruptcy laws, makes an assignment for the benefit of creditors, or appoints or suffers appointment of a receiver, trustee, or similar agent over its property.
Under the terms of the 2018 License Agreement, JHU-APL will be entitled to an eight percent (8%) royalty on net sales for the services provided by the Company as well as fifty percent (50%) of all sublicense revenues received by the Company on services and sublicenses in which the JHU-APL licensed technology was utilized.
Under the terms of the 2018 License Agreement, JHU-APL will be entitled to an eight percent (8%) royalty on net sales for the services provided by us as well as fifty percent (50%) of all sublicense revenues received by us on services and sublicenses in which the JHU-APL licensed technology was utilized.
If the product candidates of our priority programs are approved for the indications for which we are currently planning clinical trials, they will compete with the drugs discussed below and will likely compete with other drugs currently in development. bfLEAP The analytics industry and application of AI/ML in healthcare is growing rapidly.
If the product candidates of our priority programs are approved for the indications for which we are currently planning clinical trials, they will compete with the drugs discussed below and will likely compete with other drugs currently in development. 18 bfLEAP TM The analytics industry and application of AI/ML in healthcare is growing rapidly.
The license covers three (3) issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of algorithms and other trade secrets, as well as modifications and improvements. In October 2021, the Company executed an amendment to the original license for improvements and new advanced analytics capabilities.
The license covers three (3) issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of algorithms and other trade secrets, as well as modifications and improvements. In October 2021, we executed an amendment to the original license for improvements and new advanced analytics capabilities.
In October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license with JHU and the Institute of Organic Chemistry and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole that demonstrate improved solubility and bioavailability.
In October 2022, we entered into an exclusive, world-wide, royalty-bearing license with JHU and the Institute of Organic Chemistry and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole that demonstrate improved solubility and bioavailability.
Fast Track Designation The FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition.
Fast Track Designation The FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or life-threatening disease or condition for which there is no effective treatment and which demonstrates the potential to address unmet medical needs for the condition.
The bfLEAP™ platform utilizes both supervised and unsupervised machine learning; as such, it is able to reveal meaningful connections in the data without the need for a prior hypothesis. Supervised machine learning uses labeled input and output data, while an unsupervised learning algorithm does not.
The bfLEAP™ platform utilizes both supervised and unsupervised machine learning; as such, it is able to reveal meaningful connections in the data without the need for a priori hypothesis. Supervised machine learning uses labeled input and output data, while an unsupervised learning algorithm does not.
Under the terms of the new license agreement, JHU-APL will be entitled to eight percent (8%) of net sales for the services provided by the Company to other parties and three percent (3%) for internally developed drug projects in which the JHU-APL license was utilized.
Under the terms of such license agreement, JHU-APL will be entitled to eight percent (8%) of net sales for the services provided by the Company to other parties and three percent (3%) for internally developed drug projects in which the JHU-APL license was utilized.
Under the terms of the 2022 License Agreement, JHU-APL will be entitled to eight percent (8%) of net sales for the services provided by the Company to other parties and three percent (3%) for internally developed drug projects in which the JHU-APL license is utilized.
Under the terms of the 2022 License Agreement, JHU-APL will be entitled to eight percent (8%) of net sales for the services provided by us to other parties and three percent (3%) for internally developed drug projects in which the JHU-APL license is utilized.
ITEM 1. BUSINESS Our Corporate History and Background Bullfrog AI Holdings, Inc. was incorporated in the State of Nevada on February 6, 2020. Bullfrog AI Holdings, Inc. is the parent company of Bullfrog AI, Inc. and Bullfrog AI Management, LLC, which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively.
ITEM 1. BUSINESS Our Corporate History and Background BullFrog AI Holdings, Inc. was incorporated in the State of Nevada in February 2020. BullFrog AI Holdings, Inc. is the parent company of BullFrog AI, Inc. and BullFrog AI Management, LLC, which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively.
We believe that the combination of (a) scalable analytics (i.e., large data or short/wide data), (b) state-of-the-art proprietary algorithms, (c) unsupervised machine learning, and (d) streamlined data ingestion and visualization makes bfLEAP™ one of the most flexible and powerful new platforms available on the market. The Company will continue to evolve and improve bfLEAP™.
We believe that the combination of (a) scalable analytics (i.e., large data or short/wide data), (b) state-of-the-art proprietary algorithms, (c) unsupervised machine learning, and (d) streamlined data ingestion and visualization makes bfLEAP™ one of the most flexible and powerful new platforms available on the market. We intend to continue to evolve and improve bfLEAP™.
The Company assessed whether the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable; the Company expensed the license fee and will expense development costs until commercial viability is likely.
We assessed whether the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable; we expensed the license fee and will expense development costs until commercial viability is likely.
The FDA will not approve the product unless compliance with current good manufacturing practices (cGMPs) is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.
The FDA will not approve the product unless compliance with current good manufacturing practices (cGMPs) is satisfactory and the NDA contains data that provides substantial evidence that the drug is safe and effective in the indication studied.
We are able to pursue our drug asset enhancement business by leveraging a powerful and proven AI/ML platform (trade name: bfLEAP™) initially derived from technology developed at JHU-APL.
We are able to pursue our drug asset enhancement business by leveraging a powerful and proven AI/ML platform, bfLEAP™, initially derived from technology developed at JHU-APL.
The Company will be required to pay a commercial milestone of $1 million once sales reach $20 million in the United States, $2 million when sales in the United States reach $100 million, $10 million when United States sales reach $500 million, and $20 million when United States sales exceed $1 billion.
We will be required to pay a commercial milestone of $1 million once sales reach $20 million in the United States, $2 million when sales in the United States reach $100 million, $10 million when United States sales reach $500 million, and $20 million when United States sales exceed $1 billion.
On July 8, 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform. The July 8, 2022 JHU-APL license provides the Company with new intellectual property and also encompasses most of the intellectual property from our original February 2018 license agreement with JHU-APL.
In July 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform. The July 2022 JHU-APL license provides the Company with new intellectual property and also encompasses most of the intellectual property from our original February 2018 license agreement with JHU-APL.
Under the terms of the license agreement, JHU will be entitled to three- and one-half percent (3.5%) royalty on net sales by the Company in which the JHU license was utilized.
Under the terms of the license agreement, JHU will be entitled to three- and one-half percent (3.5%) royalty on net sales in which the JHU license was utilized.
In addition to salaries, these programs include incentive compensation plans, healthcare and insurance benefits, a retirement plan, paid time off, and family leave, among others. We also use targeted equity-based grants with vesting conditions to facilitate retention of personnel, particularly for our key employees. Properties Currently, the Company does not own or lease any real property.
In addition to salaries, these programs include incentive compensation plans, healthcare and insurance benefits, a retirement plan, paid time off, and family leave, among others. We also use targeted equity-based grants with vesting conditions to facilitate retention of personnel, particularly for our key employees. Properties Currently, we do not own or lease any real property.
Pharmaceutical product development for a new product or certain changes to an approved product in the U.S. typically involves preclinical laboratory and animal tests, the submission to the FDA of an investigational new drug application (“IND”) which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought.
Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA of an investigational new drug application (“IND”) which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought.
Our bfLEAP™ Analytics Platform We are able to pursue our drug rescue business by leveraging a powerful and proven AI/ML platform (trade name: bfLEAP™) derived from technology developed at JHU-APL. The bfLEAP™ platform is based on an exclusive, world-wide license granted by JHU-APL.
Our bfLEAP™ Analytics Platform We are able to pursue our drug rescue business by leveraging bfLEAP™, our powerful and proven AI/ML platform derived from technology developed at JHU-APL. The bfLEAP™ platform is based on an exclusive, world-wide license granted by JHU-APL.
These insights from bfLEAP™ analysis can be used to inform decision making and study design at the subsequent step(s) of therapeutic and diagnostic development, including first-inhuman/Phase I randomized controlled trials. 5 ● Clinical Development – Advanced, multivariate analysis of Phase I and Phase II clinical trials data, to find niche populations of highly responsive patients and/or inform patient selection for later-stage clinical trials.
These insights from bfLEAP™ analysis can be used to inform decision making and study design at the subsequent steps of therapeutic and diagnostic development, including first-inhuman and Phase I randomized controlled trials. ● Clinical Development – Advanced, multivariate analysis of Phase I and Phase II clinical trials data, to find niche populations of highly responsive patients and/or inform patient selection for later-stage clinical trials.
Generally, “Licensed Products” are any product or service which incorporates, results from, or is derived from LIBD’s Data (meaning finished brain-related data, including but not limited to DNA methylation, RNAseq, genomic, DNA methylation, cell-line, clinical, and imaging data, and the specified data set forth in the Partnership Agreement) and that the Company or its affiliate develops during the term of the Partnership Agreement, and any improvements thereof after the term of the Partnership Agreement, and all Licensed Products or services derived therefrom by the Company or its affiliates.
Generally, “Licensed Products” are any product or service which incorporates, results from, or is derived from LIBD’s Data (meaning finished brain-related data, including but not limited to DNA methylation, RNAseq, genomic, DNA methylation, cell-line, clinical, and imaging data, and the specified data set forth in the Partnership Agreement) and that we or our affiliate develops during the term of the Partnership Agreement, and any improvements thereof after the term of the Partnership Agreement, and all Licensed Products or services derived therefrom by us or our affiliates.
Both of the entities were controlled before and after the transactions by the same controlling shareholder. Bullfrog AI Corporate History Bullfrog AI, Inc. was incorporated in the State of Delaware on August 25, 2017. Vininder Singh, the Chief Executive Officer, was the founder, CEO and chairman of Bullfrog AI, Inc.
Both of the entities were controlled before and after the transactions by the same controlling shareholder. BullFrog AI Corporate History BullFrog AI, Inc. was incorporated in the State of Delaware in August 2017. Vininder Singh, the Company’s Chief Executive Officer, was the founder, CEO and chairman of BullFrog AI, Inc.
Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (“NDAs”), warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.
Failure to comply with applicable United States requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (“NDAs”), warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.
In addition, the Company is required to pay JHU minimum annual royalty payments of $5,000 for 2022, $10,000 for 2023, $20,000 for 2024, $30,000 for 2025 and $50,000 for 2026 and each year after until the first commercial sale, after which the annual minimum royalty shall be $250,000.
In addition, we are required to pay JHU minimum annual royalty payments of $5,000 for 2022, $10,000 for 2023, $20,000 for 2024, $30,000 for 2025 and $50,000 for 2026 and each year after until the first commercial sale, after which the annual minimum royalty shall be $250,000.
In consideration of the rights granted to the Company under the license agreement, GWU received a $20,000 license initiation fee.
In consideration of the rights granted to us under the license agreement, GWU received a $20,000 license initiation fee.
The Company will be responsible for milestone payments for patent issuance of up to $50,000 and clinical development milestones up to and including approval of an NDA totaling up to $2.3 million.
We will be responsible for milestone payments for patent issuance of up to $50,000 and clinical development milestones up to and including approval of an NDA totaling up to $2.3 million.
On January 14, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from George Washington University (“GWU”) for rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including hepatocellular carcinoma (“HCC”).
In January 2022, we entered into an exclusive, worldwide, royalty-bearing license from George Washington University (“GWU”) for rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including hepatocellular carcinoma (“HCC”).
In these settings, bfLEAP could be used to find novel drug targets, elucidate mechanism of action, predict potential off-target effects/side effects, uncover specific genetic/phenotypic background(s) with highest correlation to therapeutic response, etc.
In these settings, bfLEAP™ could be used to find novel drug targets, elucidate mechanism of action, predict potential off-target effects and side effects, uncover specific genetic and phenotypic backgrounds with highest correlation to therapeutic response, etc.
The Company is prohibited from sublicensing LIBD Data. The Company shall pay LIBD a royalty based on net sales of all Licensed Products sold by the Company and its affiliates.
We are prohibited from sublicensing LIBD Data. We shall pay LIBD a royalty based on net sales of all Licensed Products sold by the Company and its affiliates.
The license can be terminated by the licensee upon 60 days’ written notice, or by the licensor if the Company is more than 30 days late in paying amounts owed to the licensor and does not make payment upon demand, or in the event of any material breach of the license that is not cured within 45 days.
The license can be terminated by the licensee upon 60 days’ written notice, or by the licensor if we are more than 30 days late in paying amounts owed to the licensor and do not make payment upon demand, or in the event of any material breach of the license that is not cured within 45 days.
Johns Hopkins University – Mebendazole Prodrug License On October 13, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license with JHU and the Institute of Organic Chemistry and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole that demonstrate improved solubility and bioavailability.
Johns Hopkins University – Prodrug License In October 2022, we entered into an exclusive, worldwide, royalty-bearing license with JHU and the Institute of Organic Chemistry and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole that demonstrate improved solubility and bioavailability.
In addition, the Company is required to pay JHU-APL an annual maintenance fee of $1,500. Minimum annual royalty payments are $20,000 for 2022, $80,000 for 2023, and $300,000 per year for 2024 and beyond.
In addition, we are required to pay JHU-APL an annual maintenance fee of $1,500. Minimum annual royalty payments are $20,000 for 2022, $80,000 for 2023, and $300,000 per year for 2024 and beyond.
In February 2022, the Company entered into an exclusive, worldwide, royalty-bearing license with Johns Hopkins University (“JHU”) for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease.
Johns Hopkins University – Mebendazole License In February 2022, we entered into an exclusive, worldwide, royalty-bearing license with JHU for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease.
Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND. 18 Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.
Each protocol involving testing on United States patients and subsequent protocol amendments must be submitted to the FDA as part of the IND. Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.
All of the Company’s employees work virtually. Legal Proceedings The Company is not a party to any legal proceedings. Corporate Information Bullfrog AI Holdings, Inc. was incorporated in the State of Nevada on February 6, 2020. Our principal business address is 325 Ellington Blvd, Unit 317, Gaithersburg, MD 20878. Our website address is www.bullfrogai.com .
All of our employees work virtually. Legal Proceedings We are not a party to any legal proceedings. Corporate Information BullFrog AI Holdings, Inc. was incorporated in the State of Nevada in February 2020. Our principal business address is 325 Ellington Blvd, Unit 317, Gaithersburg, MD 20878. Our website address is www.bullfrogai.com .
The Company is currently formulating a strategy to conduct additional clinical trials with this asset to enable evaluation of safety in humans. 15 The license covers six (6) issued patents and one (1) pending application, with the term of the agreement beginning on February 22, 2022 and ending on the date of expiration of the last to expire patent.
We are currently formulating a strategy to conduct additional clinical trials with this asset to enable evaluation of safety in humans. The license covers six (6) issued patents and one (1) pending application, with the term of the agreement beginning in February 2022 and ending on the date of expiration of the last to expire patent.
Worldwide, exclusive rights for therapeutics development and analytical services George Washington University Bullfrog AI Holdings Worldwide, exclusive rights for therapeutics development Johns Hopkins University Bullfrog AI Holdings Worldwide, exclusive rights for therapeutics development JHU-APL Technology License On February 7, 2018, the Company entered into an exclusive, world-wide, royalty-bearing license with JHU-APL (the “2018 License Agreement”).
Worldwide, exclusive rights for therapeutics development and analytical services George Washington University BullFrog AI Holdings Worldwide, exclusive rights for therapeutics development Johns Hopkins University BullFrog AI Holdings Worldwide, exclusive rights for therapeutics development JHU-APL Technology License In February 2018, we entered into an exclusive, world-wide, royalty-bearing license with JHU-APL (the “2018 License Agreement”).
The license covers prodrug compositions and use for treating disease as claimed in multiple U.S. and worldwide patent applications. The term of the agreement began on October 13, 2022 and continues until the date of expiration of the last to expire patent, or for 20 years from the effective date of the agreement if no patents are issued.
The license covers prodrug compositions and use for treating disease as claimed in multiple United States and worldwide patent applications. The term of the agreement began in October 2022 and continues until the date of expiration of the last to expire patent, or for 20 years from the effective date of the agreement if no patents are issued.
The collaborations may also be at the discovery or preclinical stages of drug development. Our revenue will be a combination of fee for service payments and success fees based on achieving certain milestones as determined by each specific arrangement. There may also be fees or legal rights associated with the development of new intellectual property.
Our revenue will be a combination of fee for service payments and success fees based on achieving certain milestones as determined by each specific arrangement. There may also be fees or legal rights associated with the development of new intellectual property.
Under the terms of the license agreement, GWU will be entitled to a three percent (3%) royalty on net sales subject to quarterly minimums once the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event the Company sublicenses or assigns their rights to use the technology.
Under the terms of the license agreement, GWU will be entitled to a three percent (3%) royalty on net sales subject to quarterly minimums once the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event we sublicense or assign our rights to use the technology.
The following graphic illustrates the global revenue forecast for applying AI in the pharmaceutical industry, as well as the increase in anticipated market spend and annual growth rate for AI solutions per certain application areas. 12 Intellectual Property Patents We have exclusive worldwide rights to the following patents related to our intellectual property: Mebendazole Polymorph For Treatment And Prevention Of Tumors Serial Number Country Status Issue Date Expiration Date 62/112,706 United States Converted N/A N/A PCT/US2016/016968 PCT Nationalized N/A N/A 11,110,079 United States Granted 9/7/2021 2/8/2036 17/402,131 United States Abandoned N/A N/A 18/525,209 United States Pending N/A N/A 16747414.7 Europe Granted 12/15/2021 2/8/2036 16747414.7 Czech Republic Granted 12/15/2021 2/8/2036 16747414.7 France Granted 12/15/2021 2/8/2036 60 2016 067 384.3 Germany Granted 12/15/2021 2/8/2036 16747414.7 Ireland Granted 12/15/2021 2/8/2036 502022000018341 Italy Granted 12/15/2021 2/8/2036 16747414.7 Spain Granted 12/15/2021 2/8/2036 16747414.7 Switzerland Granted 12/15/2021 2/8/2036 16747414.7 United Kingdom Granted 12/15/2021 2/8/2036 253854 Israel Granted 6/26/2021 2/8/2036 2016800144274 China Granted 6/25/2021 2/8/2036 201717028684 India Granted 12/1/2020 2/8/2036 2017-541687 Japan Granted 11/18/2020 2/8/2036 Mebendazole Prodrugs with Enhanced Solubility and Oral Bioavailability Serial Number Country Status Issue Date Expiration Date 62/627,810 United States Converted N/A N/A PCT/US2019/017291 PCT Nationalized N/A N/A 11,712,435 United States Granted 8/1/2023 2/8/2039 2019216757 Australia Granted 1/4/2024 2/8/2039 19751700.6 Europe Pending N/A N/A 3,090,691 Canada Pending N/A N/A Inhibition of SPTBN1 to treat Obesity/NASH and Obesity/NASH-driven cancer Serial Number Country Status Filing Date Expiration Date 63/113,745 United States Converted 11/13/2020 N/A 63/147,141 United States Converted 2/8/2021 N/A PCT/US2021/059245 United States Nationalized 11/12/2021 N/A 2023-528428 Japan Filed 11/12/2021 N/A 18/252,771 United States Filed 5/12/2023 N/A 21892928.9 Europe Filed 6/13/2023 N/A 2021800763877 Canada Filed 11/12/2021 N/A 13 John Hopkins University Applied Physics Lab Licensed Intellectual Property: Title Serial Number File Date Country Status Expiration Date Assignee Apparatus and Method for Distributed Graph Processing U.S.
Intellectual Property Patents We have exclusive worldwide rights to the following patents related to our intellectual property: Mebendazole Polymorph For Treatment And Prevention Of Tumors Serial Number Country Status Issue Date Expiration Date 62/112,706 United States Converted N/A N/A PCT/US2016/016968 PCT Nationalized N/A N/A 11,110,079 United States Granted 9/7/2021 2/8/2036 17/402,131 United States Abandoned N/A N/A 18/525,209 United States Pending N/A N/A 16747414.7 Europe Granted 12/15/2021 2/8/2036 16747414.7 Czech Republic Granted 12/15/2021 2/8/2036 16747414.7 France Granted 12/15/2021 2/8/2036 60 2016 067 384.3 Germany Granted 12/15/2021 2/8/2036 16747414.7 Ireland Granted 12/15/2021 2/8/2036 502022000018341 Italy Granted 12/15/2021 2/8/2036 16747414.7 Spain Granted 12/15/2021 2/8/2036 16747414.7 Switzerland Granted 12/15/2021 2/8/2036 16747414.7 United Kingdom Granted 12/15/2021 2/8/2036 253854 Israel Granted 6/26/2021 2/8/2036 2016800144274 China Granted 6/25/2021 2/8/2036 201717028684 India Granted 12/1/2020 2/8/2036 2017-541687 Japan Granted 11/18/2020 2/8/2036 Mebendazole Prodrugs with Enhanced Solubility and Oral Bioavailability Serial Number Country Status Issue Date Expiration Date 62/627,810 United States Converted N/A N/A PCT/US2019/017291 PCT Nationalized N/A N/A 11,712,435 United States Granted 8/1/2023 2/8/2039 2019216757 Australia Granted 1/4/2024 2/8/2039 19751700.6 Europe Pending N/A N/A 3,090,691 Canada Pending N/A N/A 14 Inhibition of SPTBN1 to treat Obesity/NASH and Obesity/NASH-driven cancer Serial Number Country Status Filing Date Expiration Date 63/113,745 United States Converted 11/13/2020 N/A 63/147,141 United States Converted 2/8/2021 N/A PCT/US2021/059245 United States Nationalized 11/12/2021 N/A 2023-528428 Japan Filed 11/12/2021 N/A 18/252,771 United States Filed 5/12/2023 N/A 21892928.9 Europe Filed 6/13/2023 N/A 2021800763877 Canada Filed 11/12/2021 N/A Johns Hopkins University Applied Physics Lab Licensed Intellectual Property Title Serial Number File Date Country Status Expiration Date Assignee Apparatus and Method for Distributed Graph Processing U.S.
As contemplated in the Partnership Agreement, on October 16, 2023, the Company and LIBD entered into a commercial agreement (the “Commercial Agreement”) that sets forth the key terms for commercialization of products and services developed under the Partnership Agreement.
As contemplated in the Partnership Agreement, in October 2023, we entered into a commercial agreement (the “Commercial Agreement”) with LIBD that sets forth the key terms for commercialization of products and services developed under the Partnership Agreement.
Under the terms of the license agreement, the licensors will be entitled to a four percent (4%) royalty on net sales subject to annual minimums upon first commercial sale of a licensed product, as well as sublicense or assignment fees in the event the Company sublicenses or assigns their rights to use the technology.
Under the terms of the license agreement, the licensors will be entitled to a four percent (4%) royalty on net sales subject to annual minimums upon first commercial sale of a licensed product, as well as sublicense or assignment fees in the event we sublicense or assign our rights to use the technology.
If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus, no ANDA may be filed before the expiration of the exclusivity period.
An ANDA may be submitted one year before NCE exclusivity expires if a Paragraph IV certification is filed. If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus, no ANDA may be filed before the expiration of the exclusivity period.
Subsequent development of these assets for clinical testing may require significant effort and resources. Ultimately, these assets must undergo rigorous clinical testing and approval by FDA or comparable regulatory authorities in other countries in order to be marketed. A key part of our strategy is to partner our R&D programs.
Ultimately, these assets must undergo rigorous clinical testing and approval by FDA or comparable regulatory authorities in other countries in order to be marketed. A key part of our strategy is to partner our R&D programs.
The Company is currently formulating a strategy to find a partner to conduct additional clinical trials with this asset to enable evaluation of safety in humans.
We are currently formulating a strategy to find a partner to conduct additional clinical trials with this asset to enable evaluation of safety in humans.
In addition, we do not intend on commercializing drugs and instead will seek to divest each drug asset to a company that will commercialize the drug. The Company may receive future royalties in some transactions.
In addition, we do not intend on commercializing drugs and instead will seek to divest each drug asset to a company that will commercialize the drug.
The sublicense fee amount declines as the Company advances the clinical development of licensed technology. The Company is required to pay minimum annual royalties beginning in year 4 of the agreement.
The sublicense fee amount declines as we advance the clinical development of licensed technology. We are required to pay minimum annual royalties beginning in year 4 of the agreement.
We have applied the technology to various clinical data sets and have identified novel relationships that may provide new intellectual property, new drug targets, and other valuable information that may help with patient stratification for a clinical trial thereby improving the odds for success. The platform has not yet aided in the development of a drug that has reached commercialization.
We have applied the technology to various clinical data sets and have identified novel relationships that may provide new intellectual property, new drug targets, and other valuable information that may help with patient stratification for a clinical trial, thereby improving the odds for success.
The top arrow shows the number of failed Phase III trials for several disease categories over a 5-year period. The arrows below provide our assumptions for narrowing or discounting certain parameters associated with the market size calculation. The final arrow shows the math behind the $47.1 billion market opportunity.
The graphic below illustrates the estimated market opportunity for these failed drugs. The top arrow shows the number of failed Phase III trials for several disease categories over a 5-year period. The arrows below provide our assumptions for narrowing or discounting certain parameters associated with the market size calculation.
The FDA will regulate any clinical trials conducted by the Company. Our clinical development programs will, in some cases, require regulatory review of preclinical and/or clinical data by the FDA or other governing agencies, and subsequent compliance with applicable federal, state, local, and foreign statutes and regulations.
Our clinical development programs will, in some cases, require regulatory review of preclinical and/or clinical data by the FDA or other governing agencies, and subsequent compliance with applicable federal, state, local, and foreign statutes and regulations. The results of the clinical trials that we conduct will be evaluated by the FDA and other regulatory bodies.
In particular, we depend on the skills, experience and performance of our senior management and R&D personnel. We compete for qualified personnel with other healthcare technology, pharmaceutical, and healthcare companies, as well as universities and non-profit research institutions. We provide competitive compensation and benefits programs to help meet the needs of our employees.
We compete for qualified personnel with other healthcare technology, pharmaceutical, and healthcare companies, as well as universities and non-profit research institutions. We provide competitive compensation and benefits programs to help meet the needs of our employees.
The cost of preparing and submitting an NDA is substantial. The submission of most NDAs is additionally subject to a substantial application user fee, and the applicant under an approved NDA is also subject to an annual program fee for each prescription product. These fees are typically increased annually.
The submission of most NDAs is additionally subject to a substantial application user fee, and the applicant under an approved NDA is also subject to an annual program fee for each prescription product. These fees are typically increased annually. Sponsors of applications for drugs granted Orphan Drug Designation are exempt from these user fees.
The license covers methods claimed in three U.S. and worldwide patent applications, and also includes use of this approach for treatment of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis. This program is currently in the preclinical stage of development.
The license covers methods claimed in three (3) U.S. and worldwide patent applications, and also includes use of this approach for treatment of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis. This program is currently in the preclinical stage of development and we have not yet initiated development activities or IND-enabling studies on this asset.
On July 8, 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform (the “2022 License Agreement”). The new license provides additional intellectual property rights including patents, copyrights, and knowhow to be utilized under the Company’s bfLEAP™ analytical AI/ML platform.
In July 2022, we entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform, which superseded our original license with JHU-APL. This license provides additional intellectual property rights including patents, copyrights and knowhow to be utilized under our bfLEAP™ analytical AI/ML platform.
The process for our drug asset enhancement program is to: ● acquire the rights to a drug from a biopharmaceutical industry company or academia; ● use the proprietary bfLEAP™ AI/ML platform to determine a multi-factorial profile for a patient that would best respond to the drug; ● rapidly conduct a clinical trial to validate the drug’s use for the defined “high-responder” population; and ● divest and sell the rescued drug asset with the new information back to a large player in the pharma industry, following positive results of the clinical trial.
The process for our drug asset enhancement program is to: ● acquire the rights to a drug from a biopharmaceutical industry company or academia; ● use the proprietary bfLEAP™ AI/ML platform to determine a multi-factorial profile for a patient that would best respond to the drug; ● rapidly conduct a clinical trial to validate the drug’s use for the defined “high-responder” population; and ● divest and sell the rescued drug asset with the new information back to a large player in the pharma industry, following positive results of the clinical trial. 6 As part of our strategy, we will continue evolving our 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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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We have not encountered cybersecurity challenges that have materially impaired our operations or financial standing. Governance Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function. The board of directors’ audit committee is responsible for overseeing Company’s cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats.
We have not encountered cybersecurity challenges that have materially impaired our operations or financial standing. Governance Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function. The board of directors’ audit committee is responsible for overseeing the Company’s cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats.
We routinely assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing therein. 22 We conduct periodic risk assessments to identify cybersecurity threats, as well as assessments in the event of a material change in our business practices that may affect information systems that are vulnerable to such cybersecurity threats.
We routinely assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing therein.
Added
We conduct periodic risk assessments to identify cybersecurity threats, as well as assessments in the event of a material change in our business practices that may affect information systems that are vulnerable to such cybersecurity threats.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Our tradeable warrants are traded on Nasdaq and began trading under the symbol “BFRGW” on February 14, 2023. Holders of Record As of March 4, 2025, we had 15 shareholders of record of our common stock. This number does not include beneficial owners whose shares are held by nominees in street name.
Our tradeable warrants are traded on Nasdaq and began trading under the symbol “BFRGW” on February 14, 2023. Holders of Record As of the date of this filing, we had 21 shareholders of record of our common stock. This number does not include beneficial owners whose shares are held by nominees in street name.
Any future disposition of dividends will be at the discretion of our Board of Directors and will depend upon, among other things, our future earnings, operating and financial condition, capital requirements, and other factors. Recent Sales of Unregistered Securities None.
Any future disposition of dividends will be at the discretion of our Board of Directors and will depend upon, among other things, our future earnings, operating and financial condition, capital requirements, and other factors.
Issuer Purchases of Equity Securities The Company did not repurchase any of its equity securities during the fourth quarter ended December 31, 2024.
Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the year ended December 31, 2025.
Added
Recent Sales of Unregistered Securities Other than as previously reported in the Company’s Current Reports on Form 8-K, there were no unregistered sales of equity securities during the year ended December 31, 2025.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

41 edited+36 added−13 removed24 unchanged
Our objective is to utilize bfLEAP™, our AI/ML platform, with a precision medicine approach toward drug development with biopharmaceutical collaborators, as well as our own internal clinical development programs.
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.
Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. 43
Subsequently, we have developed new tools and capabilities composed of an ensemble of machine learning and artificial intelligence models. In February 2018, the Company secured an original exclusive, worldwide, royalty-bearing license from JHU-APL for the technology underlying our bfLEAP™ platform.
Subsequently, we have developed new tools and capabilities composed of an ensemble of machine learning and artificial intelligence models. In February 2018, we secured an original exclusive, worldwide, royalty-bearing license from JHU-APL for the technology underlying our bfLEAP™ platform.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION The following discussion and analysis of the results of operations and financial condition of Bullfrog AI Holdings, Inc.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS AND PLAN OF OPERATION The following discussion and analysis of the results of operations and financial condition of BullFrog AI Holdings, Inc.
As of December 31, 2024, the Company’s cash and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the filing date of the consolidated financial statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
As of December 31, 2025, the Company’s cash and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the filing date of the consolidated financial statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
(“Bullfrog” or the “Company”) as of and for the years ended December 31, 2024 and 2023 should be read in conjunction with our consolidated financial statements and the notes to those consolidated financial statements that are included elsewhere in this Annual Report on Form 10-K.
(“BullFrog” or the “Company”) as of and for the years ended December 31, 2025 and 2024 should be read in conjunction with our consolidated financial statements and the notes to those consolidated financial statements that are included elsewhere in this Annual Report on Form 10-K.
Critical Accounting Policies In Note 2 of our Audited Financial Statements for the year ended December 31, 2024 found elsewhere in this Annual Report on Form 10-K, we included a discussion of the most critical accounting policies used in the preparation of our financial statements.
Critical Accounting Policies In Note 2 of our Audited Financial Statements for the year ended December 31, 2025 found elsewhere in this Annual Report on Form 10-K, we included a discussion of the most critical accounting policies used in the preparation of our financial statements.
Emerging Growth Company and Smaller Reporting Company Status The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies.
Emerging Growth Company and Smaller Reporting Company Status We are an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies.
Bullfrog AI Holdings, Inc. is the parent company of Bullfrog AI, Inc. and Bullfrog AI Management, LLC, which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively. Operations are currently conducted through Bullfrog AI Holdings, Inc., which began operations on February 6, 2020.
BullFrog AI Holdings, Inc. is the parent company of BullFrog AI, Inc. and BullFrog AI Management, LLC, which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively. Operations are currently conducted through BullFrog AI Holdings, Inc., which began operations in February 2020.
Actual results could differ materially because of the factors discussed in “Risk Factors” elsewhere in this Annual Report on Form 10-K, and other factors that we may not know. 24 OVERVIEW Bullfrog AI Holdings, Inc. was incorporated in the State of Nevada on February 6, 2020.
Actual results could differ materially because of the factors discussed in “Risk Factors” elsewhere in this Annual Report on Form 10-K, and other factors that we may not know. 37 OVERVIEW BullFrog AI Holdings, Inc. was incorporated in the State of Nevada in February 2020.
In July 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from JHU-APL that provides additional intellectual property rights including patents, copyrights, and knowhow for the technology underlying the Company’s bfLEAP™ analytical AI/ML platform. In consideration for the new license entered into in July 2022 with JHU-APL, the Company issued to JHU-APL 39,879 shares of common stock.
In July 2022, we entered into an exclusive, worldwide, royalty-bearing license from JHU-APL that provides additional intellectual property rights including patents, copyrights, and knowhow for the technology underlying our bfLEAP™ analytical AI/ML platform. In consideration for the new license entered into in July 2022 with JHU-APL, we issued to JHU-APL 39,879 shares of common stock.
Internally, the Company has added incremental staff to accelerate execution and the development of processes and custom scripts for use in performing new drug target discovery and analytical services for customers, while also launching initiatives targeting large public health data sources and seeking access to proprietary health data sources, such as our agreement with the LIBD.
Internally, we have added incremental staff to accelerate execution and the development of processes and custom scripts for use in performing new drug target discovery and analytical services for customers, while also launching initiatives targeting large public health data sources and seeking access to proprietary health data sources, such as our agreement with the LIBD.
The Company has had negative cash flows from operations and operated at a net loss since inception. In the first quarter of 2023, we completed our IPO. In February 2024, we received net proceeds of approximately $5.7 million from an underwritten secondary public offering of common stock and warrants.
We have had negative cash flows from operations and operated at a net loss since inception. In the first quarter of 2023, we completed our IPO. In February 2024, we received net proceeds of approximately $5.7 million from an underwritten public offering of common stock and warrants.
The first of these payments of $75,000 was paid in July 2023 and the remaining payments of $75,000, $75,000 and $50,000 are due in years 2025, 2026 and 2027, respectively. The amendment also reduced the 2023 minimum annual royalty payment to $60,000. All other financial terms remain the same.
The first of these payments of $75,000 was paid in July 2023, the second of these payments was paid in June 2025, and the remaining payments of $75,000 and $50,000 are due in years 2026 and 2027, respectively. The amendment also reduced the 2023 minimum annual royalty payment from $80,000 to $60,000. All other financial terms remain the same.
References in this Management’s Discussion and Analysis of Financial Condition and Results of Operations to “us”, “we”, “our” and similar terms refer to the Company. This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains statements that are forward-looking. These statements are based on current expectations and assumptions that are subject to risk, uncertainties, and other factors.
References in this Management’s Discussion and Analysis of Financial Condition and Plan of Operation to “us”, “we”, “our” and similar terms refer to the Company. This Management’s Discussion and Analysis of Financial Condition and Plan of Operation contains statements that are forward-looking. These statements are based on current expectations and assumptions that are subject to risk, uncertainties, and other factors.
We have signed exclusive worldwide License Agreements with JHU for a cancer drug that targets glioblastoma (brain cancer), pancreatic cancer, and others. We have also signed an exclusive worldwide license from George Washington University for another cancer drug that targets hepatocellular carcinoma (liver cancer) and other liver diseases.
We have signed exclusive worldwide license agreements with JHU for a cancer drug that targets glioblastoma (brain cancer), pancreatic cancer, and others. We have also signed an exclusive worldwide license from GWU for another cancer drug that targets hepatocellular carcinoma (liver cancer) and other liver diseases.
The Company and JHU-APL entered into Amendment Number 1 of the July 2022 license agreement pursuant to which the Company gained access to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $275,000.
In May 2023, we entered into Amendment Number 1 of the July 2022 license agreement with JHU-APL pursuant to which we gained access to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $275,000.
We anticipate our research and development costs could become significant as we execute on our business plan and begin conducting preclinical research and development activities directed at securing development partners and filing an IND for our licensed drug development programs described in this filing, as well as under strategic partnerships and for other drug development programs we may acquire.
We anticipate that our research and development costs could become significant over time as we execute on our business plan and begin conducting preclinical research and development activities directed at securing development partners and filing an investigational new drug (IND) application for our licensed drug development programs described in this filing, as well as under strategic partnerships and for other drug development programs we may acquire.
In February 2024, we completed an underwritten offering of common stock and warrants generating approximately $5.7 million of net proceeds. In October 2024, we completed a registered direct offering of common stock and pre-funded warrants, and concurrent private placement of common stock warrants generating approximately $2.7 million of net proceeds.
In October 2024, we completed a registered direct offering of common stock and pre-funded warrants, and concurrent private placement of common stock warrants generating approximately $2.7 million of net proceeds.
In addition to fees paid to external service providers, we are also allocating internal costs for personnel working on these efforts in addition to personnel costs related to our internal efforts to develop our product and service offerings using bfLEAP™.
In addition to fees paid to external service providers, we are also allocating costs for internal personnel working on these activities as well as their efforts to develop our product and service offerings using bfLEAP™.
We also transitioned our accounting and financial reporting systems and processes to enhance our internal control environment as a public company.
We are also continuing to improve our accounting and financial reporting systems and processes to enhance our internal control environment as a public company.
General and Administrative Expenses General and administrative costs and expenses in 2023 and 2024 include personnel costs and costs associated with being a public company such as D&O insurance, audit and tax provider fees, SEC legal counsel, and exchange listing costs. Additionally, our general and administrative costs include expenses for our business development, investor relations and marketing efforts.
General and Administrative Expenses General and administrative costs and expenses include personnel costs and costs associated with being a public company such as directors and officers insurance, audit and tax provider fees, legal fees, and exchange listing costs. Additionally, our general and administrative costs include expenses for our business development, investor relations and marketing efforts.
The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing and/or revenues to meet its obligations arising from normal business operations when they become due. Our Strategy The Company has a unique strategy designed to reduce risk and increase the frequency of cash flow.
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. 39 Our Strategy We have a strategy designed to reduce risk and increase the frequency of cash flow.
The first part of the strategy is to generate revenues through strategic relationships with biopharma companies. These relationships will be structured as a combination of fees and intellectual property based on the specific scope of the engagement.
The first part of the strategy is to generate revenues through strategic relationships with biopharma companies. These relationships will be structured as a combination of fees in cash and, in some instances, equity in our partners, or other consideration and intellectual property based on the specific scope of the engagement.
As of December 31, 2024, we have accrued $300,000 of the 2024 minimum annual royalty payments, and the entire accrued balance was paid in January 2025. We intend to continue to evolve and improve bfLEAP™, either in-house or with development partners like JHU-APL.
As of December 31, 2025, we have accrued $300,000 for the 2025 minimum annual royalty payments and the entire accrued balance remains uninvoiced and unpaid as of the date of this filing. We intend to continue to evolve and improve bfLEAP™, either in-house or with development partners like JHU-APL.
We plan to leverage our proprietary AI/ML platform developed over several years at one of the top innovation institutions in the world, which has already been successfully applied in multiple sectors.
We plan to leverage our proprietary AI/ML platform developed over several years at one of the top innovation institutions in the world, which has already been successfully applied in multiple sectors. 38 We operate and have staffed our business using funds from our initial public offering and subsequent financings.
Additionally, in October 2024, we received net proceeds of approximately $2.7 million from a registered direct offering of common stock and pre-funded warrants, and concurrent private placement of common stock warrants. As of December 31, 2024, the Company has a cash balance of approximately $5.4 million.
In October 2024, we received net proceeds of approximately $2.7 million from a registered direct offering of common stock and pre-funded warrants, and concurrent private placement of common stock warrants. Through December 31, 2025, we received approximately $2.6 million of net proceeds from the sale of our common stock pursuant to the ATM Agreement.
We anticipate that our expenses will increase in the future to support our service offerings, clinical and pre-clinical research and development activities associated with strategic partnering and collaborations, as well as acquired product candidates. These increases could include increased costs related to the hiring of additional personnel and fees to outside consultants, lawyers, and accountants, among other expenses.
We anticipate that our expenses will increase in the future to support our service offerings, clinical and pre-clinical research and development activities associated with strategic partnering and collaborations, as well as acquired product candidates.
In the future, the second part of our strategy involves acquiring the rights to drugs at various stages of development and using our proprietary AI/ML technology to advance the development of such drugs, with the objective of creating near term value and then exiting and monetizing as quickly as possible, preferably within approximately 30 months. 26 Results of Operations For the years ended December 31, 2024 and 2023 Revenue and Costs of Goods Sold We recognized $65,000 in revenue and $5,200 in costs of goods sold during the year ended December 31, 2023 related to a commercial service contract.
In the future, the second part of our strategy involves acquiring the rights to drugs at various stages of development and using our proprietary AI/ML technology to advance the development of such drugs, with the objective of creating near term value and then exiting and monetizing as quickly as possible, preferably within approximately 30 months.
Research and Development Costs and Expenses Research and development costs and expenses in 2023 and 2024 include development activities on our licensed drug candidates and our discovery collaborations with JCVI.
Research and Development Costs and Expenses Research and development costs and expenses include development activities related to our licensed drug candidates and our discovery efforts and collaborations.
This may make it difficult to compare our financial results with the financial results of another public company that is either not an emerging growth company or is an emerging growth company that has chosen not to take advantage of the extended transition period exemptions because of the potential differences in accounting standards used. 29 We are also considered a “smaller reporting company”, meaning that the market value of our stock held by non-affiliates plus the aggregate amount of gross proceeds to us as a result of the IPO is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year.
We are also considered a “smaller reporting company”, meaning that the market value of our stock held by non-affiliates plus the aggregate amount of gross proceeds to us as a result of the IPO is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year.
These factors raise substantial doubt about the Company’s ability to continue as a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing and/or revenues to meet its obligations arising from normal business operations when they become due.
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. Accordingly, we will seek additional capital to continue to execute our strategy as discussed above.
During 2024, we received approximately $0.1 million from the exercise of warrants. As of December 31, 2024, the Company’s cash and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the filing date of the consolidated financial statements.
As of December 31, 2025, our cash and cash equivalents position is not sufficient to fund our planned operations for at least a year beyond the filing date of the consolidated financial statements. These factors raise substantial doubt about our ability to continue as a going concern.
Cash Flows Provided by Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 decreased by approximately $147,000, compared to the same period ended December 31, 2023 primarily due to fewer proceeds from equity issuances in 2024 partially offset by payments of debt in 2023.
Cash Flows Provided by Financing Activities Net cash provided by financing activities for the year ended December 31, 2025 decreased, compared to the year ended December 31, 2024, primarily due to proceeds from our offerings and warrant exercises in 2024, partially offset by proceeds from sales of common stock under our ATM Agreement in 2025.
We have staffed our business using funds from our initial public offering and subsequent financings and have entered into partnerships and relationships and recently completed our first commercial service contract with a leading rare disease non-profit organization for AI/ML analysis of late-stage clinical data.
Since our incorporation, we have entered into various partnerships and relationships, completed our first commercial service contract with a leading rare disease non-profit organization for AI/ML analysis of late-stage clinical data in 2023, and completed our collaboration agreement for clinical trial optimization with a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers in the third quarter of 2025.
Interest income increased by approximately $77,000 primarily due to an increase in our average cash balances. Liquidity and Capital Resources Through December 31, 2024, the Company has an accumulated deficit of approximately $16.8 million and has funded its operations through the sale of common stock, warrants and debt.
Liquidity and Capital Resources Through December 31, 2025, we have an accumulated deficit of approximately $23.3 million and we have funded our operations through the sale of common stock, warrants and debt.
Since we are a company focused on using our AI/ML technology to advance medicines, any clinical development programs will also require, in all cases, partners and the establishment of third-party relationships for execution and completion of clinical trials. 25 Since completing our initial public offering in February 2023 (the “IPO”), aided by the receipt of the IPO proceeds in addition to the proceeds from our February 2024 and October 2024 offerings, we have implemented several initiatives: investor relations and marketing to promote and raise awareness of the Company in the financial and business sectors, research and development, collaboration with J Craig Venter Institute (“JCVI”) and initiated preclinical studies with our in-licensed drug programs.
Since completing our initial public offering in February 2023 (the “IPO”), aided by the receipt of the IPO proceeds in addition to the proceeds from our February 2024 and October 2024 offerings and our ongoing At-The-Market Sales Agreement with BTIG, LLC (the “ATM Agreement”) and common stock purchase agreement with Lincoln Park Capital Fund, LLC, we have implemented several initiatives including: investor relations and marketing to raise awareness of the Company in the financial and business sectors, research and development, and initiation of preclinical studies with our in-licensed drug programs.
Consolidated Cash Flow Data Year ended December 31, Net Change 2024 2023 Net cash (used in) provided by Operating activities $ (5,610,249 ) $ (6,001,299 ) $ 391,050 Investing activities - - - Financing activities 8,421,502 8,568,359 (146,857 ) Net increase in cash and cash equivalents $ 2,811,253 $ 2,567,060 $ 244,193 Cash Flows Used in Operating Activities Net cash used in operating activities for the year ended December 31, 2024 decreased by approximately $391,000 compared to the same period ended December 31, 2023 primarily due to paying down accrued expenses for technology access, consultants, and compensation in 2023, partially offset by increased operating costs in 2024 primarily relating to increased personnel costs.
Consolidated Cash Flow Data Year ended December 31, 2025 2024 Net Change Net cash (used in) provided by Operating activities $ (5,522,265 ) $ (5,610,249 ) $ 87,984 Investing activities - - - Financing activities 2,374,987 8,421,502 (6,046,515 ) Net (decrease) increase in cash and cash equivalents $ (3,147,278 ) $ 2,811,253 $ (5,958,531 ) Cash Flows Used in Operating Activities Net cash used in operating activities for the year ended December 31, 2025 decreased by approximately $88,000 compared to the year ended December 31, 2024, primarily due to decreased operating costs in 2025 attributable to a reduction in personnel costs, partially offset by the timing and payment of vendor invoices and associated impact to accounts payable.
Other Income (Expense), Net Interest expense decreased by approximately $61,000 for the year ended December 31, 2024, compared to the same period ended December 31, 2023 due to our outstanding notes converting or being paid off in 2023. In 2023, we also recognized a loss on the conversion of notes of approximately $93,000 in the year ended December 31, 2023.
Other Income (Expense), Net Interest expense decreased by approximately $12,000 for the year ended December 31, 2025, compared to the same period ended December 31, 2024 due to a decrease in our director and officer insurance policy premium loan. Interest income decreased by approximately $159,000 primarily due to a decrease in our average cash balances.
Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements, as such term is defined in Item 303(a)(4) of Regulation S-K. 28 Financial Operations Overview Revenue We completed our first commercial service contract and recognized revenue in the amount of $65,000 in the third quarter of 2023. We did not recognize any revenue in 2024.
Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements, as such term is defined in Item 303(a)(4) of Regulation S-K. 42 Financial Operations Overview Revenue In February 2025, we entered into a collaboration agreement with Eleison Pharmaceuticals Inc., a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers, and we recognized revenue of approximately $117,000 pursuant to this agreement.
Operating Expenses Year ended December 31, Net Change 2024 2023 $ % Operating expenses: Research and development $ 2,223,265 $ 1,432,614 $ 790,651 55 % General and administrative 5,013,118 3,994,710 1,018,408 25 % Total operating expenses $ 7,236,383 $ 5,427,324 $ 1,809,059 33 % Research and Development Our research and development expenses for the year ended December 31, 2024 increased by approximately $791,000 or 55% compared the year ended December 31, 2023, primarily due to increased personnel costs related to the hiring of additional R&D staff members.
Operating Expenses Year ended December 31, Net Change 2025 2024 $ % Operating expenses: Research and development $ 1,799,738 $ 2,223,265 $ (423,527 ) -19 % General and administrative 4,816,790 5,013,118 (196,328 ) -4 % Total operating expenses $ 6,616,528 $ 7,236,383 $ (619,855 ) -9 % Research and Development Our research and development expenses for the year ended December 31, 2025 decreased compared the year ended December 31, 2024, primarily due to a reduction in personnel costs and the allocation of certain personnel costs from research and development to cost of revenue related to our collaboration with Eleison.
Removed
We did not recognize any revenue in the year ended December 31, 2024.
Added
Since we are a company focused on using our AI/ML technology to advance medicines, any clinical development programs will also require, in all cases, partners and the establishment of third-party relationships for execution and completion of clinical trials.
Removed
In addition, in the first quarter of 2024, we engaged disease experts as area consultants, we expanded our target discovery efforts, and we also initiated a preclinical obesity study related to an siRNA program. Going forward, we expect our R&D expenses to increase as we begin the validation process on potential targets identified in our target discovery program.
Added
As of December 31, 2025, the Company has a cash balance of approximately $2.3 million, which includes restricted cash of $0.1 million held by a financial institution as collateral for the Company’s corporate credit card program.
Removed
General and Administrative Our general and administrative expenses for the year ended December 31, 2024 increased by approximately $1,018,000 or 25% compared to the year ended December 31, 2023, primarily due to increased personnel costs related to the hiring of additional staff members, as well as associated increases in equity compensation costs and recruiting fees as we work to expand our headcount and capabilities.
Added
Results of Operations For the years ended December 31, 2025 and 2024 Collaboration Revenue and Cost of Collaboration Revenue In the year ended December 31, 2025, we recognized revenue and cost of revenue of approximately $117,000 and $95,000, respectively, which entirely related to our lone collaboration agreement with Eleison Pharmaceuticals Inc.
Removed
In February 2023, the Company completed its IPO of 1,297,318 units at a price of $6.50 per unit for a total of approximately $8.4 million of gross proceeds.
Added
(“Eleison”), a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers. We had no active customer agreements in the year ended December 31, 2024 and, therefore, no revenue was recognized.
Removed
Each unit consists of one share of the Company’s common stock, one tradeable warrant to purchase one share of common stock at an exercise price of $7.80 per share, and one non-tradeable warrant to purchase one share of the Company’s common stock at an exercise price of $8.125.
Added
General and Administrative Our general and administrative expenses for the year ended December 31, 2025 decreased compared to the year ended December 31, 2024, primarily due to reductions in our director and officer insurance policy premium and recruiting fees, partially offset by an increase in noncash stock-based compensation expense.
Removed
In connection with, and immediately prior to, the IPO, the Company also completed a 1-for-7 reverse stock split of our common stock. In connection with the IPO, a simple agreement for future equity (“SAFE”) and convertible loan agreement held by a related party converted into 55,787 shares of common stock.
Added
These increases could include increased costs related to the hiring of additional personnel and fees to outside consultants, lawyers, and accountants, among other expenses. 40 In February 2024, we completed an underwritten offering of common stock and warrants generating approximately $5.7 million of net proceeds.
Removed
Additionally, all outstanding convertible bridge notes and accrued interest were converted into 276,289 shares of common stock and 276,289 warrants to purchase common stock and were issued to the holders of such notes at conversion. 27 In April 2023, the holders of outstanding warrants exercised 436,533 warrants for common stock at various exercise prices and the Company received net proceeds of approximately $1.5 million.
Added
In April 2025, we entered into an ATM Agreement with BTIG, LLC, pursuant to which we may offer and sell shares of common stock, from time to time in our sole discretion, at the market price up to an aggregate offering price of $20 million.
Removed
Accordingly, we will seek additional capital to continue to execute our strategy as discussed above.
Added
We are not obligated to sell any shares, and BTIG is not required to sell any specific number or dollar amount of shares of common stock. Accordingly, we will not receive any proceeds from such transaction until shares are actually sold by BTIG.
Removed
There has been no material change in the policies and estimates used in the preparation of our financial statements since the completion of the 2024 audit.
Added
Subject to our request to sell shares, BTIG will use commercially reasonable efforts, consistent with its normal trading and sales practices, to sell shares of common stock on our behalf in accordance with Company instructions.
Removed
In February 2025, we announced our entry into a collaboration agreement with Eleison Pharmaceuticals Inc. (“Eleison”), a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers. We are in discussions with other potential partners, although there can be no assurance of entering into other business relationships in 2025 or beyond.
Added
Notwithstanding the foregoing, there can be no assurance that we will be able to sell, when needed, sufficient shares under the ATM Agreement to fund planned operations.
Removed
Operating Expenses We classify our operating expenses into two categories: research and development and general and administrative. Prior to 2023, most of our activities were related to: technology evaluation, acquisition and validation, capital acquisition and business development activities in general, which we believe have readied the Company for contract services while exploring strategic partnering and asset acquisition.
Added
In the year ended December 31, 2025, we received approximately $2.6 million of net proceeds from the sale of 1,686,511 shares of our common stock at an average price of approximately $1.59 per share.
Removed
These activities and related expenditures have been recorded and reported as general and administrative in our financial statements. In 2022, we licensed two drug development programs from universities and entered into a new license with JHU-APL for new intellectual property and other enhancements used with our bfLEAP™ platform.
Added
Subsequent to year end 2025, we received approximately $0.9 million of net proceeds from the sale of 976,204 shares of our common stock at an average price of approximately $0.90 per share.
Removed
We incurred license and annual minimum royalty fees associated with these relationships in 2023 and 2024, and we expect our research and development expenses to increase in 2025 as we initiate activities directed towards the development of service offering products, collaborations and preclinical studies aimed at generating the data to enable the filing of an Investigational New Drug (IND) application.
Added
Consequently, as of the date of this filing, approximately $16.4 million of capacity remains available under the ATM Agreement; however, the amount we are permitted to raise in any 12-month period is currently limited based on our public float pursuant to SEC General Instruction I.B.6 of Form S-3.
Added
Accordingly, as of the date of this filing, we are limited to additional common stock sales of approximately $1.1 million under the ATM Agreement.
Added
In September 2025, we entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $10.0 million of our common stock, subject to certain limitations.
Added
We have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of our common stock.
Added
Such sales of common stock by the Company, if any, will be subject to certain limitations set forth in the purchase agreement, and may occur from time to time, at our sole discretion, over the 36-month period commencing on November 25, 2025, the date that the conditions to Lincoln Park’s purchase obligation set forth in the purchase agreement were satisfied.
Added
In connection with the purchase agreement, we issued 147,682 shares of common stock valued at approximately $207,000 to Lincoln Park as a fee in advance of any sales pursuant to this facility. No shares were sold under this facility during the year ended December 31, 2025.
Added
In January 2026, we received net proceeds of approximately $218,000 from the sale of 270,000 shares of common stock at an average price of approximately $0.81 per share.
Added
On August 21, 2025, we received a letter from the listing staff of The Nasdaq Stock Market LLC (“Nasdaq”) that we were no longer in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Rule”).
Added
The Stockholders’ Equity Rule requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 or to meet alternatives of market value of listed securities or net income from continuing operations, which we do not currently meet.
Added
In accordance with Nasdaq rules, we had 45 calendar days, or until October 6, 2025, to submit a plan to regain compliance. After submitting the plan to regain compliance, on October 7, 2025, Nasdaq granted us an extension until February 17, 2026, to comply with Listing Rule 5550(b)(1).
Added
On February 19, 2026, we received a further notice from Nasdaq (the “February Letter”) notifying us that Nasdaq determined that we had not met the terms of the extension.
Added
We thereafter timely requested a hearing before an independent Nasdaq Hearings Panel (the “Panel”) which automatically stayed any suspension or delisting action pending the hearing and the expiration of any extension period granted by the Panel following the hearing.
Added
At the hearing, we plan to present additional details of our Plan and provide an update on our efforts to regain compliance.
Added
We will also request additional time to complete the steps of our Plan and regain compliance with all applicable Nasdaq Listing Rules. 41 On February 10, 2026, we received a letter from Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock, par value $0.00001 per share (the “Common Stock”), was below $1.00 per share, which is the minimum closing bid price required for continued listing on the Nasdaq Global Market (the “Minimum Bid Price Requirement”) pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Notice”).

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