Core Insights - Bullfrog AI Holdings, Inc. is hosting a webinar on April 23, 2025, to discuss its innovative use of AI and machine learning in drug development [1] - The company's proprietary bfLEAP™ platform, developed at Johns Hopkins Applied Physics Lab, aims to uncover hidden biological insights and optimize clinical strategies [2] - Bullfrog AI is pursuing a dual growth strategy by generating recurring revenue through its Data Networks platform while advancing a pipeline of licensed drug assets in collaboration with leading research institutions [2] Company Overview - Bullfrog AI leverages AI and machine learning to enhance drug discovery and development, aiming to streamline therapeutics development and reduce clinical trial failure rates [4] - The company utilizes causal AI in combination with its bfLEAP™ platform to analyze complex biological data [4] Webinar Details - The webinar will include a live question and answer session following the presentation, allowing attendees to engage directly with the company's CEO [3] - Registration for the free webinar is available online, and questions can be pre-submitted or asked during the event [3]

Group 1 - Bullfrog AI Holdings, Inc. is hosting a webinar on April 23, 2025, at 4:15 p.m. ET to discuss its innovative use of AI and machine learning in drug development [1] - The company's proprietary bfLEAP™ platform, developed at Johns Hopkins Applied Physics Lab, is designed to help biopharma firms uncover hidden biological insights and optimize clinical strategies using high-dimensional, multi-modal data [2] - Bullfrog AI's growth strategy includes driving recurring revenue through its scalable Data Networks platform while advancing a pipeline of licensed drug assets in collaboration with top-tier research institutions [2] Group 2 - The webinar will include a live question and answer session, allowing attendees to engage directly with the company's CEO, Vin Singh [3] - Interested participants can register for the free webinar and submit questions in advance via email or during the live event [3] - Bullfrog AI aims to streamline therapeutics development and reduce failure rates in clinical trials by leveraging causal AI and its bfLEAP™ platform [4]

Part I [Business](index=5&type=section&id=Item%201.%20Business) Bullfrog AI Holdings, Inc. leverages its bfLEAP™ platform for drug development through contract services, collaborations, and asset acquisition - The company utilizes its **bfLEAP™ AI/ML platform** to accelerate drug development and reduce costs[23](index=23&type=chunk) - The business model encompasses **contract services, collaborative arrangements with milestone payments, and strategic drug asset acquisition and divestiture**[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - Exclusive worldwide licenses include a **mebendazole formulation for cancer** and an **siRNA-based therapeutic for liver diseases**[31](index=31&type=chunk)[36](index=36&type=chunk) - A strategic partnership with **Lieber Institute for Brain Development (LIBD)** focuses on identifying new biomarkers and drug targets for neurological disorders[47](index=47&type=chunk) - In February 2025, a collaboration with **Eleison Pharmaceuticals** began to analyze clinical data for their pancreatic cancer drug, glufosfamide[25](index=25&type=chunk)[46](index=46&type=chunk) [Risk Factors](index=25&type=page&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, the company is exempt from providing specific risk factor disclosures - Smaller reporting companies are **not required to provide** the information for this item[119](index=119&type=chunk) [Unresolved Staff Comments](index=25&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - Not applicable[120](index=120&type=chunk) [Cybersecurity](index=25&type=section&id=Item%201C.%20Cybersecurity) The company integrates cybersecurity risk management into its overall framework, overseen by the audit committee, with no material incidents reported - Cybersecurity risk management is integrated into overall risk systems, with periodic assessments to identify and manage threats[121](index=121&type=chunk)[122](index=122&type=chunk) - The board's **audit committee oversees cybersecurity risk management**, receiving regular reports from the IT team[126](index=126&type=chunk)[128](index=128&type=chunk) - To date, no cybersecurity incidents have materially affected the company's operations or financial condition[125](index=125&type=chunk) [Properties](index=26&type=section&id=Item%202.%20Properties) The company operates virtually with no owned or leased real property, maintaining a principal business address - The company **does not own any real property**, with all employees working virtually[129](index=129&type=chunk) [Legal Proceedings](index=26&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal or administrative proceedings - The company is **not currently a party to any legal or administrative proceedings**[130](index=130&type=chunk) [Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[131](index=131&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=27&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock and warrants trade on Nasdaq, with no dividends paid or anticipated, and no equity repurchases in Q4 2024 - Common stock (**BFRG**) and tradeable warrants (**BFRGW**) commenced trading on the Nasdaq Capital Market on **February 14, 2023**[133](index=133&type=chunk) - The company has **not paid dividends since inception** and plans to retain future earnings for business development[135](index=135&type=chunk) - No equity securities were repurchased during the **fourth quarter ended December 31, 2024**[138](index=138&type=chunk) [Management's Discussion and Analysis of Financial Condition and Plan of Operation](index=27&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Plan%20of%20Operation) The company reported no revenue in 2024, with operating expenses increasing 33% to $7.2 million, leading to a $7.0 million net loss and substantial doubt about its going concern ability Operating Expenses Comparison (2024 vs 2023) | Operating Expenses | 2024 ($) | 2023 ($) | Net Change ($) | Net Change (%) | | :--- | :--- | :--- | :--- | :--- | | 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%** | - The company's cash balance of approximately **$5.4 million** as of December 31, 2024, is insufficient for a year of operations, raising **substantial doubt about its going concern ability**[149](index=149&type=chunk)[165](index=165&type=chunk) Consolidated Cash Flow Data (2024 vs 2023) | Cash Flow Activity | 2024 ($) | 2023 ($) | Net Change ($) | | :--- | :--- | :--- | :--- | | Net cash used in Operating activities | $(5,610,249) | $(6,001,299) | $391,050 | | Net cash used in Investing activities | - | - | - | | Net cash provided by Financing activities | $8,421,502 | $8,568,359 | $(146,857) | - The company, as an emerging growth company, has elected to use the **extended transition period** for new financial accounting standards compliance[176](index=176&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative market risk disclosures - As a smaller reporting company, the company is **not required to provide** the information for this item[178](index=178&type=chunk) [Financial Statements and Supplementary Data](index=34&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the full consolidated financial statements and supplementary data appended to the Form 10-K, starting on page F-1 - The required financial statements are appended to the report, commencing on **page F-1**[179](index=179&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=34&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding financial disclosure - None[180](index=180&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of December 31, 2024, due to a material weakness in internal controls, with remediation efforts underway - Management concluded that **disclosure controls and procedures were ineffective** as of December 31, 2024, due to material weaknesses in internal control over financial reporting[181](index=181&type=chunk) - A material weakness was identified due to inadequate documentation, implementation, or operation of effective internal controls over financial reporting, a weakness also present in 2023[184](index=184&type=chunk) - Remediation efforts include transitioning accounting to an external firm, implementing a new accounting platform, and hiring a **Corporate Controller in 2024**[186](index=186&type=chunk)[189](index=189&type=chunk) [Other Information](index=35&type=section&id=Item%209B.%20Other%20Information) No new 10b5-1 plans were adopted in Q4 2024, though CEO Vininder Singh's existing plan resulted in 50,000 shares sold - CEO Vininder Singh's 10b5-1 sales plan, effective until August 31, 2025, or 1,000,000 shares sold, resulted in **50,000 shares sold in each of Q2, Q3, and Q4 2024**[188](index=188&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=35&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[189](index=189&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=36&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) The company's leadership includes CEO Vininder Singh and CFO Josh Blacher, with independent directors overseeing key committees and a commitment to board diversity - Executive officers include **Vininder Singh (CEO)** and **Josh Blacher (CFO)**, supported by independent directors R. Donald Elsey, William Enright, and Jason D. Hanson[192](index=192&type=chunk) - The board comprises four male directors, with a stated commitment to seeking qualified women and minority candidates despite lacking a formal diversity policy[200](index=200&type=chunk) - The company has established **Audit, Compensation, and Nominating & Corporate Governance committees**, each composed of independent directors[203](index=203&type=chunk)[205](index=205&type=chunk)[208](index=208&type=chunk) - A **Clawback Policy**, effective December 1, 2023, allows for recovery of incentive-based compensation from executive officers upon material financial restatement[211](index=211&type=chunk) [Executive Compensation](index=42&type=section&id=Item%2011.%20Executive%20Compensation) In 2024, CEO Vininder Singh's total compensation was $630,680, while non-executive directors received $45,000 in cash and $34,050 in option awards 2024 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Option Awards ($) | Total Compensation ($) | | :--- | :--- | :--- | :--- | :--- | | Vininder Singh, CEO | 2024 | $400,000 | $230,680 | $630,680 | | Dane Saglio, former CFO | 2024 | $252,581 | $100,740 | $353,321 | | Josh Blacher, CFO | 2024 | $10,631 | $ - | $10,631 | 2024 Director Compensation | Name | Fees Earned in Cash ($) | Option Awards ($) | Total Compensation ($) | | :--- | :--- | :--- | :--- | | R. Donald Elsey | $45,000 | $34,050 | $79,050 | | William Enright | $45,000 | $34,050 | $79,050 | | Jason D. Hanson | $45,000 | $34,050 | $79,050 | - The **2022 Equity Incentive Plan** authorizes equity awards, with **150,682 shares available** for issuance as of December 31, 2024[228](index=228&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=46&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 4, 2025, CEO Vininder Singh holds 26.09% beneficial ownership, with all officers and directors owning 28.20% collectively Security Ownership of Beneficial Owners (as of March 4, 2025) | Name of Beneficial Owner | Percentage of Common Stock | | :--- | :--- | | Vininder Singh (CEO and Director) | 26.09% | | All officers and directors as a group (6 persons) | 28.20% | | Tivoli Trust | 8.81% | | Empery Asset Management, LP | 9.88% | Equity Compensation Plan Information | Plan Category | Securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-average exercise price ($) | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 763,514 | $4.04 | 150,682 | | Equity compensation plans not approved by security holders | 747,376 | $1.69 | 0 | | **Total** | **1,510,890** | **$2.88** | **150,682** | [Certain Relationships and Related Transactions, and Director Independence](index=48&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company discloses related party transactions with Tivoli Trust, including converted SAFE and convertible loan agreements, and maintains a formal approval policy - Upon the IPO in February 2023, a **$150,000 SAFE agreement** with Tivoli Trust converted into **32,967 common shares**[241](index=241&type=chunk) - In February 2023, a **$99,900 convertible loan** with a related party converted into **21,747 common shares**[242](index=242&type=chunk) - The company's policy requires audit committee review and approval for related person transactions exceeding **$120,000** or **1% of average total assets**[244](index=244&type=chunk)[245](index=245&type=chunk) [Principal Accounting Fees and Services](index=49&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) M&K CPAs billed $71,545 in 2024 and $71,750 in 2023 for audit and audit-related services, all pre-approved by the audit committee Accountant Fees (M&K CPAs) | Fee Category | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Audit fees | $44,725 | $35,200 | | Audit-related fees | $26,820 | $36,550 | | Tax fees | - | - | | All other fees | - | - | | **Total fees** | **$71,545** | **$71,750** | - The audit committee's policy requires **pre-approval of all auditing and permitted non-audit services** performed by the auditors[248](index=248&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=50&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides a comprehensive list of financial statements and all exhibits filed with the Form 10-K, including key agreements and certifications - This item provides a list of consolidated financial statements and a **detailed index of all exhibits** filed with the report[253](index=253&type=chunk) [Form 10-K Summary](index=52&type=section&id=Item%2016.%20Form%2010-K%20Summary) No summary is provided under this item - None[255](index=255&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=55&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The independent auditor issued a fair presentation opinion but included a "Going Concern" paragraph due to recurring losses and financial position - The auditor's report expresses **substantial doubt about the company's going concern ability** due to recurring losses and its financial position as of December 31, 2024[266](index=266&type=chunk) - The auditor identified 'Going Concern' as a **critical audit matter**, citing significant judgment in auditing management's future expenditure estimates[271](index=271&type=chunk) [Consolidated Financial Statements](index=57&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements detail the company's financial position, operations, and cash flows, showing a 2024 net loss of $7.0 million and $5.44 million in cash Consolidated Balance Sheet Data (as of Dec 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5,435,983 | $2,624,730 | | Total current assets | $5,547,580 | $2,770,612 | | **Total assets** | **$5,551,830** | **$2,776,586** | | **Liabilities and Equity** | | | | Total current liabilities | $588,090 | $184,350 | | **Total liabilities** | **$588,090** | **$184,350** | | Total stockholders' equity | $4,963,740 | $2,592,236 | | **Total liabilities and stockholders' equity** | **$5,551,830** | **$2,776,586** | Consolidated Statement of Operations Data (for the Year Ended Dec 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Revenue | $ - | $65,000 | | Gross profit | $ - | $59,800 | | Total operating expenses | $7,236,383 | $5,427,324 | | Loss from operations | $(7,236,383) | $(5,367,524) | | **Net loss** | **$(6,993,647)** | **$(5,355,869)** | | Net loss per common share - basic and diluted | $(0.85) | $(0.89) | [Notes to Consolidated Financial Statements](index=61&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes to financial statements detail liquidity concerns, stockholders' equity components, and material agreements including significant royalty and milestone payment obligations - Note 1 (Liquidity and Going Concern) indicates the company's **~$5.4 million cash** as of December 31, 2024, is insufficient for a year of operations, raising **substantial doubt about its going concern ability**[293](index=293&type=chunk) - Note 8 (Stockholders' Equity) shows the company raised gross proceeds of **~$6.5 million in February** and **~$3.13 million in October 2024** through common stock and warrant offerings[336](index=336&type=chunk)[337](index=337&type=chunk) - Note 10 (Material Agreements) outlines significant future financial commitments, including **$300,000 minimum annual royalty payments** to JHU-APL and potential milestone payments for licensed drug candidates[357](index=357&type=chunk)[358](index=358&type=chunk)[360](index=360&type=chunk) - Note 12 (Subsequent Events) details a February 2025 collaboration with **Eleison Pharmaceuticals Inc.** to analyze clinical trial data for an investigational pancreatic cancer treatment[366](index=366&type=chunk)

Core Insights - BullFrog AI Holdings, Inc. has entered a collaboration with Eleison Pharmaceuticals to enhance clinical trial efficiency and patient insights using its BullFrog Data Networks™ AI solution [1][2] - The partnership aims to apply AI technology to analyze clinical data from Eleison's ongoing Phase 3 trial of glufosfamide, a treatment for pancreatic cancer, to improve trial design and decision-making [2][3] Company Overview - BullFrog AI is a technology-enabled drug development company that utilizes artificial intelligence and machine learning to facilitate the development of pharmaceuticals and biologics [1][4] - Eleison Pharmaceuticals focuses on developing novel chemotherapeutic treatments for rare cancers and has multiple programs in late-stage clinical development, including glufosfamide for pancreatic cancer [5] Clinical Trial Details - Glufosfamide is currently being evaluated in a pivotal Phase 3 international randomized clinical trial for second-line treatment of pancreatic cancer, which is a leading cause of cancer-related deaths in the U.S. [3] - The ongoing Phase 3 trial is expected to be completed by 2027, with glufosfamide designed to have greater specificity and reduced systemic toxicities compared to traditional treatments [3] Strategic Implications - The collaboration is expected to generate deeper insights into patient responses and safety trends, benefiting not only the glufosfamide program but also Eleison's broader oncology pipeline [4] - BullFrog AI's bfLEAP platform will evaluate safety signals and extract predictive biomarkers to support future trial designs, potentially accelerating the path to market for life-saving therapies [2][4]

GAITHERSBURG, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced its participation in the TechBio track at Biotech Showcase and RESI JPM, both taking place during the annual JP Morgan Healthcare Conference in San Francisco, January 13–16, 2025. At both ...

GAITHERSBURG, Md., Dec. 27, 2024 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, issued a letter to stockholders from its CEO Vin Singh. Dear Fellow Stockholders, As the year comes to a close, I want to extend my deepest gratitude for your unwavering support and belief in our mission ...

GAITHERSBURG, Md., Dec. 17, 2024 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ:BFRG, BFRGW)) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced the appointment of Josh Blacher as its Chief Financial Officer (CFO), effective immediately. This appointment comes in the wake of the untimely passing of Dane Saglio, BullFrog AI's forme ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to Commission File Number 001-41600 BULLFROG AI HOLDINGS, INC. (Exact name of registrant as specified in its charter) Nevada 84-4786155 (State or other j ...

GAITHERSBURG, Md., Oct. 22, 2024 (GLOBE NEWSWIRE) -- BullFrog AI, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced its VP Artificial Intelligence, Enrique García-Rivera, Ph.D., will present at Google’s inaugural Cancer AI Symposium on October 30, 2024, at the Boston Center for the Arts. Dr. García-Rivera’s pre ...

Core Viewpoint - BullFrog AI Holdings, Inc. has successfully closed a definitive agreement for the purchase and sale of 1,565,000 shares of common stock and common warrants, raising approximately $3.13 million in gross proceeds from the offering [1][2]. Group 1: Offering Details - The offering includes a registered direct offering and a concurrent private placement, with a combined purchase price of $2.00 per share [1]. - The common warrants have an exercise price of $2.00 per share, are initially exercisable six months from issuance, and will expire five years from the initial exercise date [1]. - The shares and warrants will be issued under an effective shelf registration statement previously filed with the SEC [3]. Group 2: Financial and Legal Aspects - The gross proceeds from the offering are expected to be approximately $3.13 million, excluding any proceeds from the exercise of the warrants and before deducting placement agent fees and other expenses [2]. - WallachBeth Capital, LLC acted as the sole placement agent for the offering, while Sheppard, Mullin, Richter & Hampton LLP served as counsel to the placement agent [2]. Group 3: Company Background - WallachBeth Capital provides a range of capital markets and investment banking services, particularly to the healthcare sector, including initial public offerings and private transactions [4].