Bullfrog AI (BFRG)
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ZCMD, ABCL, VOR, IXHL, OVID, BFRG Rally After Hours On Clinical Momentum And Recent Updates
RTTNews· 2025-10-02 05:09
Core Insights - Several biotech and healthcare stocks experienced significant after-hours gains on October 1, driven by technical momentum and recent clinical updates rather than new disclosures [1] Company Summaries - Zhongchao Inc. (ZCMD) saw a 14.04% increase in after-hours trading, rising to $1.30 from $1.14, despite no new filings or press releases [2] - AbCellera Biologics Inc. (ABCL) rose 11.41% in after-hours trading, closing at $6.64, following an 18.49% gain during the regular session, attributed to recent clinical trial progress [3][4] - Vor Biopharma Inc. (VOR) surged 9.53% in after-hours trading, recovering from a 19.42% drop during the regular session, with no new updates since a recent announcement regarding clinical data presentation [5] - Incannex Healthcare Inc. (IXHL) gained 6.48% in after-hours trading, partially recovering from a 6.94% drop, with the latest update showing positive Phase 2 trial results for PSX-001 [6] - Ovid Therapeutics Inc. (OVID) shares rose 8.03% in after-hours trading, building on a 5.38% gain during the regular session, with recent earnings report indicating a narrower net loss and higher revenue [7] - Bullfrog AI Holdings Inc. (BFRG) advanced 3.44% in after-hours trading, following a 3.57% rise during the regular session, after announcing an expansion of its sales and marketing team [8]
BullFrog AI Expands Sales and Marketing Team to Accelerate Commercial Adoption of Clinical Trial Optimization Solutions and bfPREP™ Module
Globenewswire· 2025-09-30 12:00
Core Insights - BullFrog AI Holdings, Inc. is expanding its internal sales organization to enhance the commercialization of its clinical trial optimization offerings, particularly the bfPREP™ module [1][2][3] Group 1: Sales Expansion and Strategy - The expansion of the in-house sales capabilities is designed to accelerate the adoption of BullFrog AI's trial-focused platforms among pharmaceutical and biotechnology companies [2][4] - The company is implementing a dual-pronged strategy by collaborating with Sygnature Discovery while also strengthening its direct sales organization to broaden its commercial reach [3][4] Group 2: Product Offerings - The bfPREP module is specifically developed to manage the complexity of diverse clinical trial data, transforming raw information into standardized formats quickly [3][4] - Once data is standardized through bfPREP, other platforms like bfLEAP can be utilized to identify patient subgroups and enhance trial design and execution [4] Group 3: Market Demand and Future Outlook - There is a growing demand for technologies that minimize risk and cost in clinical development, positioning BullFrog AI to accelerate revenue growth and create long-term shareholder value [5]
BullFrog AI and Sygnature Discovery Announce Official Sales Launch of BullFrog Data Networks™ to Global Biopharma Clients
Globenewswire· 2025-09-25 12:00
Core Insights - BullFrog AI Holdings, Inc. has entered a commercial phase in collaboration with Sygnature Discovery, unlocking a potential revenue opportunity of $15–$30 million through 2028 [1][2][3] Group 1: Commercial Launch - The sales kickoff for BullFrog Data Networks™ occurred on September 12, marking a significant milestone for the company [1] - Sygnature's global business development team has completed training to effectively market BullFrog Data Networks™ [2] Group 2: Technology and Applications - BullFrog Data Networks™ utilizes AI and machine learning to assist researchers in navigating complex datasets, with applications in target identification, mechanism-of-action elucidation, patient stratification, drug repurposing, and clinical trial optimization [3][4] - The platform aims to enhance R&D efficiency and unlock the full potential of biopharma data [4] Group 3: Company Background - BullFrog AI focuses on advancing drug discovery and development through collaborations with leading research institutions and employs causal AI alongside its proprietary bfLEAP™ platform [4] - Sygnature Discovery is a prominent contract research organization with over 1,000 employees, specializing in drug discovery across various therapeutic areas [5]
BullFrog AI to Showcase AI-Powered Clinical Data Solutions in Xtalks Webinar
Globenewswire· 2025-09-23 12:00
Core Insights - BullFrog AI Holdings, Inc. is leveraging AI and machine learning to enhance drug development processes, focusing on reliable automation with human oversight [1][4] Webinar Details - A live webinar titled "Clinical Data Analysis with Agents: Reliable Automation with Human Oversight" will be presented by Dr. Juan Felipe Beltrán Lacouture on October 6, 2025, at 11:00 am EDT [1][7] - The webinar aims to showcase how BullFrog AI's platforms, bfPREP™ and bfLEAP™, can transform unstructured clinical data into structured datasets for advanced analysis [2][6] Technology and Methodology - BullFrog AI has successfully converted over 10,000 pages of unstructured clinical PDFs into an OMOP-structured dataset, facilitating machine learning applications [2] - The company emphasizes a balance between automation speed and the necessary human oversight to ensure data integrity and reliability [3][4] - The approach focuses on verified automation rather than full automation, aiming to enhance clinical research workflows while maintaining quality control [3] Commitment to Data Integrity - The CEO of BullFrog AI, Vin Singh, highlighted the company's commitment to advancing data integrity and reliability in drug development, showcasing the practical applications of their technologies [4]
BullFrog AI’s bfPREP™ and bfLEAP® Platforms Deliver Real-World Impact in Eleison Pharmaceuticals Collaboration
Globenewswire· 2025-09-08 12:00
Core Insights - BullFrog AI is collaborating with Eleison Pharmaceuticals to enhance drug development for rare cancers using AI and machine learning technologies [1][7] - The company has developed a new data ingestion module, bfPREP, which effectively converts complex clinical trial data into a standardized format, demonstrating its capability in handling large datasets [2][3] - BullFrog AI's analytics engine, bfLEAP, is utilized to identify patient subgroups, which can inform trial design and market positioning for Eleison's therapies [5][6] Collaboration and Technology - The bfPREP module was designed to process over 10,000 pages of clinical trial PDFs, transforming them into a strategic asset for Eleison [2][3] - The company employs a combination of automation and human oversight to ensure data accuracy while scaling data preparation efforts [4] - The collaboration is set to culminate in a joint scientific submission to an oncology conference, which is expected to validate the commercial value of BullFrog AI's platforms [7] Market Position and Future Prospects - The partnership with Eleison is seen as a proof point for the broader application of BullFrog AI's solutions across the pharmaceutical industry [6][8] - The biopharma sector's need to reduce risk and costs in clinical development presents significant opportunities for BullFrog AI's technologies [8] - Eleison is advancing multiple late-stage clinical programs, indicating a robust pipeline that could benefit from BullFrog AI's analytics capabilities [9]
Bullfrog AI (BFRG) - 2025 Q2 - Quarterly Report
2025-08-13 20:59
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details the company's financial statements, management's analysis, and internal controls [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements and related notes, addressing liquidity and going concern [Condensed Consolidated Balance Sheets (unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) This section provides a summary of the company's financial position, detailing assets, liabilities, and equity at specific dates Condensed Consolidated Balance Sheets Summary | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $2,473,635 | $5,435,983 | $(2,962,348) | | Total current assets | $2,702,472 | $5,547,580 | $(2,845,108) | | Total assets | $2,869,194 | $5,551,830 | $(2,682,636) | | Total current liabilities | $681,084 | $588,090 | $92,994 | | Total stockholders' equity | $2,188,110 | $4,963,740 | $(2,775,630) | - Total assets decreased by approximately **$2.68 million**, and total stockholders' equity decreased by approximately **$2.78 million** from December 31, 2024, to June 30, 2025[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations (unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) This section outlines the company's financial performance, including revenue, expenses, and net loss over specific periods Condensed Consolidated Statements of Operations Summary | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $33,257 | $- | $33,257 | $- | | Gross profit | $6,522 | $- | $6,522 | $- | | Total operating expenses | $1,476,195 | $1,681,963 | $3,532,815 | $3,647,681 | | Net loss | $(1,448,729) | $(1,611,646) | $(3,466,282) | $(3,515,440) | | Net loss per common share (basic and diluted) | $(0.15) | $(0.20) | $(0.36) | $(0.46) | - The company recognized collaboration revenue and gross profit for the first time in the three and six months ended June 30, 2025[18](index=18&type=chunk) - Net loss decreased by **$162,917** for the three months ended June 30, 2025, and by **$49,158** for the six months ended June 30, 2025, compared to the prior year periods[18](index=18&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(unaudited)) This section details changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit Changes in Stockholders' Equity Summary | Metric | December 31, 2024 | June 30, 2025 | Change | | :-------------------------- | :---------------- | :-------------- | :----- | | Common Stock Shares (Number) | 9,113,139 | 9,627,114 | 513,975 | | Additional Paid-in Capital | $21,757,204 | $22,447,851 | $690,647 | | Accumulated Deficit | $(16,793,556) | $(20,259,838) | $(3,466,282) | | Total Stockholders' Equity | $4,963,740 | $2,188,110 | $(2,775,630) | - The accumulated deficit increased by approximately **$3.47 million** from December 31, 2024, to June 30, 2025, primarily due to net losses[21](index=21&type=chunk) - Issuance of common stock, net of issuance costs, contributed **$212,459** to additional paid-in capital in the quarter ended June 30, 2025[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) This section presents the company's cash inflows and outflows from operating, investing, and financing activities Consolidated Cash Flow Data Summary | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(3,230,098) | $(3,132,149) | $(97,949) | | Net cash provided by financing activities | $372,750 | $6,121,507 | $(5,748,757) | | Net (decrease) increase in cash and cash equivalents | $(2,857,348) | $2,989,358 | $(5,846,706) | | Cash and cash equivalents, and restricted cash at end of period | $2,578,635 | $5,614,088 | $(3,035,453) | - Net cash provided by financing activities decreased significantly by approximately **$5.75 million** for the six months ended June 30, 2025, compared to the same period in 2024[24](index=24&type=chunk) - The company experienced a net decrease in cash and cash equivalents of approximately **$2.86 million** for the six months ended June 30, 2025, compared to a net increase of approximately **$2.99 million** in the prior year[24](index=24&type=chunk) [Notes to Condensed Consolidated Financial Statements (unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section provides detailed explanations of the accounting policies, significant transactions, and other financial information - The company's cash balance of approximately **$2.6 million** as of June 30, 2025, is not sufficient to fund planned operations for at least a year, raising substantial doubt about its ability to continue as a going concern[32](index=32&type=chunk) - The company plans to raise additional capital through various avenues including sales of equity securities, debt transactions, licensing agreements, and collaborative arrangements[33](index=33&type=chunk) [1. Organization and Nature of Business](index=9&type=section&id=1.%20Organization%20and%20Nature%20of%20Business) This section describes the company's business model, objectives, and its liquidity and going concern status - Bullfrog AI Holdings, Inc. focuses on advanced AI/ML-driven analysis of complex data sets in medicine and healthcare, aiming to provide precision medicine approaches to drug asset enablement[27](index=27&type=chunk) - The company's core platform technology, bfLEAP™, was developed at The Johns Hopkins University Applied Physics Laboratory (JHU-APL) and is used for internal programs and strategic partnerships[29](index=29&type=chunk) [Description of Business](index=9&type=section&id=Description%20of%20Business) This section details the company's mission to use AI/ML for precision medicine and drug asset enablement - The company's objective is to utilize its AI/ML platform to provide a precision medicine approach to drug asset enablement through external partnerships and selective internal development[27](index=27&type=chunk) - The bfLEAP™ platform leverages both correlative and causative machine learning and artificial intelligence approaches to provide comprehensive predictive analysis and meaningful insights[30](index=30&type=chunk) [Liquidity and Going Concern](index=9&type=section&id=Liquidity%20and%20Going%20Concern) This section addresses the company's financial viability and ability to continue operations - As of June 30, 2025, the company has a cash balance of approximately **$2.6 million**, which is not sufficient to fund planned operations for at least a year, raising substantial doubt about its ability to continue as a going concern[32](index=32&type=chunk) - The company anticipates raising additional capital through equity securities sales, debt transactions, licensing agreements, and collaborative arrangements[33](index=33&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and estimates used in preparing the financial statements - The company's significant accounting policies have not materially changed during the six months ended June 30, 2025, compared to its 2024 Annual Report on Form 10-K, except as noted[35](index=35&type=chunk) - The company views its operations and manages its business as one operating segment, focused on advancing drug development using AI/ML[40](index=40&type=chunk) [Basis of Presentation](index=10&type=section&id=Basis%20of%20Presentation) This section explains the framework and principles used for preparing the unaudited financial statements - The unaudited condensed consolidated financial statements are prepared in conformity with United States generally accepted accounting principles (GAAP) for interim financial information[36](index=36&type=chunk) [Segment Reporting](index=10&type=section&id=Segment%20Reporting) This section clarifies that the company operates as a single segment focused on AI/ML drug development - The company operates as a single operating segment, focused on advancing drug development using AI/ML to analyze complex data sets in medicine and healthcare[40](index=40&type=chunk) - The Chief Operating Decision Maker (CODM) assesses company performance through the achievement of target identification goals and monitors cash and cash equivalents for liquidity needs[40](index=40&type=chunk)[41](index=41&type=chunk) [Revenue Recognition](index=11&type=section&id=Revenue%20Recognition) This section details the company's five-step model for recognizing revenue from collaborations and partnerships - The company recognizes revenue based on a five-step model, with future revenues expected from discovery and monetization of new drug targets and fee-for-service partnerships[42](index=42&type=chunk)[45](index=45&type=chunk) - Consideration for services may include cash, equity, or other consideration, and in some instances, rights to new intellectual property[42](index=42&type=chunk) [Investments](index=11&type=section&id=Investments) This section describes the company's accounting treatment for its equity investment in a privately held entity - The company has a single investment in equity securities of a privately held entity, received as remuneration for services, and accounts for it using the measurement alternative (cost minus impairment) due to the lack of a readily determinable fair value[43](index=43&type=chunk) [Financial Instruments](index=11&type=section&id=Financial%20Instruments) This section explains the valuation methods for financial instruments and their fair value measurements - The carrying value of short-term instruments (cash, accounts payable, accrued expenses) approximates fair value due to their short maturity[44](index=44&type=chunk) - The company utilizes a three-level valuation hierarchy for fair value measurements but does not have any assets or liabilities measured at fair value on a recurring basis[44](index=44&type=chunk)[46](index=46&type=chunk) [Recent Accounting Pronouncements](index=12&type=section&id=Recent%20Accounting%20Pronouncements) This section discusses the impact of recently issued accounting standards on the company's financial reporting - ASU No. 2023-09: Income Taxes (Topic 740) is effective for the company's fiscal year ending December 31, 2025, requiring additional income tax disclosures but not affecting recognition or measurement[47](index=47&type=chunk) [3. Investments](index=12&type=section&id=3.%20Investments) This section details the company's sole equity investment in a private entity and its valuation method - The company's sole investment is in equity securities of a private entity, initially valued at approximately **$58,000**, received as remuneration for services[49](index=49&type=chunk) - The investment is carried at its estimated fair value (cost minus impairment) using the measurement alternative, with no fair value adjustments or impairment charges recognized as of June 30, 2025[49](index=49&type=chunk) [4. Revenue](index=12&type=section&id=4.%20Revenue) This section describes the recognition of collaboration revenue from a single customer agreement in the quarter - In the quarter ended June 30, 2025, the company recognized approximately **$33,000** of revenue from a single customer agreement for contract services, upon completion of a deliverable[50](index=50&type=chunk)[51](index=51&type=chunk) - The initial payment for these services was received in the form of equity securities of the customer, valued at approximately **$58,000**, with the balance reflected as deferred revenue[50](index=50&type=chunk)[51](index=51&type=chunk) [5. Notes Payable](index=13&type=section&id=5.%20Notes%20Payable) This section outlines the company's financing arrangement for its directors and officers insurance premium - In February 2025, the company financed **$181,797** of its directors and officers insurance premium[53](index=53&type=chunk) - The agreement provides for 10 equal monthly installments of **$18,743** through December 2025, accruing interest at **6.70%**[53](index=53&type=chunk) [6. Stockholders' Equity](index=13&type=section&id=6.%20Stockholders'%20Equity) This section details the company's preferred stock, common stock, equity incentive plan, options, and warrants - As of June 30, 2025, the company had **9,627,114** shares of common stock issued and outstanding, and **73,449** shares of Series A Convertible Preferred Stock outstanding[15](index=15&type=chunk)[21](index=21&type=chunk) - The company has an At-The-Market (ATM) Sales Agreement with BTIG, LLC, allowing it to sell up to **$20.0 million** in common stock, with approximately **$19.7 million** capacity remaining as of June 30, 2025, subject to SEC limitations[58](index=58&type=chunk)[59](index=59&type=chunk) [Preferred Stock](index=13&type=section&id=Preferred%20Stock) This section describes the issued and outstanding Series A Convertible Preferred Stock and its conversion terms - As of June 30, 2025, **73,449** shares of Series A Convertible Preferred Stock were issued and outstanding[54](index=54&type=chunk) - Each Series A share is convertible into **10** shares of common stock, has no voting rights, and is subject to a **4.99%** ownership blocker[54](index=54&type=chunk) [Common Stock](index=13&type=section&id=Common%20Stock) This section summarizes the company's common stock issuances, including proceeds from various offerings - In February 2024, the company received approximately **$6.5 million** gross proceeds from the sale of **1,247,092** common shares, pre-funded warrants, and common warrants[56](index=56&type=chunk) - In October 2024, the company received approximately **$3.13 million** gross proceeds from a registered direct offering and concurrent private placement of common stock and warrants[57](index=57&type=chunk) - In June 2025, the company received approximately **$346,000** gross proceeds from the sale of **211,589** common shares through its ATM Agreement[59](index=59&type=chunk) [2022 Equity Incentive Plan](index=14&type=section&id=2022%20Equity%20Incentive%20Plan) This section outlines the authorized shares and awards under the company's equity incentive plan - The 2022 Equity Incentive Plan authorizes equity-based awards with an initial maximum of **900,000** shares and an automatic annual increase to **15%** of total outstanding shares[61](index=61&type=chunk) - As of June 30, 2025, **497,260** awards are authorized but unissued under the Plan[61](index=61&type=chunk) [Stock Options](index=14&type=section&id=Stock%20Options) This section provides a summary of outstanding stock options, their exercise prices, and compensation expense Stock Option Activity Summary | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :---------------- | | Outstanding Stock Options (Number) | 938,927 | 832,731 | | Weighted Average Exercise Price ($) | $3.57 | $3.96 | | Weighted Average Remaining Contractual Term (Years) | 8.3 | 8.5 | - The company recognized **$478,193** in stock-based compensation expense related to stock options for the six months ended June 30, 2025[64](index=64&type=chunk) - As of June 30, 2025, total unrecognized compensation expense for unvested stock options was approximately **$238,000**, expected to be recognized over approximately **1.5 years**[65](index=65&type=chunk) [Warrants](index=15&type=section&id=Warrants) This section details the company's outstanding warrants, their exercise prices, and anti-dilution adjustments Outstanding Warrants as of June 30, 2025 | Exercise Price ($) | Expiration | Number of Warrants (Number) | | :------------- | :--------- | :----------------- | | $0.0007 | 2030 | 274,286 | | $2.00 - $2.66 | 2026 - 2032 | 2,164,179 | | $3.36 - $4.16 | 2028 - 2029 | 1,842,807 | | $6.51 - $7.80 | 2026 - 2032 | 1,484,829 | | $8.125 | 2028 | 1,443,227 | | **Total** | | **7,209,328** | - Warrant issuances in February and October 2024 led to anti-dilution adjustments, reducing the exercise price of **90,419** IPO warrants and resulting in deemed dividends of **$16,774** and **$28,211**, respectively[67](index=67&type=chunk)[71](index=71&type=chunk) - No compensation expense related to warrants issued as consideration for services was recognized for the six months ended June 30, 2025, as no unvested warrants remain[69](index=69&type=chunk)[70](index=70&type=chunk) [7. Income Taxes](index=17&type=section&id=7.%20Income%20Taxes) This section explains the company's income tax position, including the absence of tax provision and valuation allowance - The company has not recorded any tax provision or benefit for the six months ended June 30, 2025 or 2024[72](index=72&type=chunk) - A full valuation allowance has been provided for net deferred tax assets due to the uncertainty of realizing future benefits[72](index=72&type=chunk) [8. Material Agreements](index=17&type=section&id=8.%20Material%20Agreements) This section outlines the company's key licensing agreements for its AI/ML platform and drug candidates - The company holds exclusive, worldwide, royalty-bearing licenses for its bfLEAP™ AI/ML platform from JHU-APL and for various drug candidates from George Washington University and Johns Hopkins University[73](index=73&type=chunk)[74](index=74&type=chunk)[77](index=77&type=chunk)[79](index=79&type=chunk)[81](index=81&type=chunk) - All licensed programs are currently in early stages, and associated license fees and development costs are expensed rather than capitalized, as commercial viability is not yet likely[76](index=76&type=chunk)[78](index=78&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) [JHU-APL Technology License](index=17&type=section&id=JHU-APL%20Technology%20License) This section details the exclusive license for the bfLEAP™ platform, including royalty rates and minimum payments - The 2022 License Agreement with JHU-APL grants exclusive, worldwide rights to the bfLEAP™ platform, with royalties of **8%** for services and **3%** for internal drug projects[74](index=74&type=chunk) - Minimum annual royalty payments are **$300,000** for 2024 and beyond, with **$150,000** accrued for 2025 as of June 30, 2025[74](index=74&type=chunk)[76](index=76&type=chunk) [George Washington University - Beta2-spectrin siRNA License](index=17&type=section&id=George%20Washington%20University%20-%20Beta2-spectrin%20siRNA%20License) This section describes the exclusive license for siRNA targeting Beta2-spectrin and associated royalty terms - The company holds an exclusive, worldwide license from GWU for siRNA targeting Beta2-spectrin for treating human diseases, including hepatocellular carcinoma[77](index=77&type=chunk) - The agreement includes a **3%** royalty on net sales (post-regulatory approval) and annual license maintenance fees, with **$10,000** accrued for the **$20,000** fee for 2025[78](index=78&type=chunk) [Johns Hopkins University – Mebendazole License](index=18&type=section&id=Johns%20Hopkins%20University%20%E2%80%93%20Mebendazole%20License) This section outlines the exclusive license for an improved Mebendazole formulation for cancer treatment - The company has an exclusive, worldwide license from JHU for an improved Mebendazole formulation for human cancer treatment[79](index=79&type=chunk) - The license includes a **3.5%** royalty on net sales and tiered minimum annual royalty payments, with **$15,000** accrued for the **$30,000** minimum for 2025[80](index=80&type=chunk) [Johns Hopkins University – Mebendazole Prodrug License](index=18&type=section&id=Johns%20Hopkins%20University%20%E2%80%93%20Mebendazole%20Prodrug%20License) This section details the exclusive license for N-substituted Mebendazole prodrugs for improved bioavailability - The company holds an exclusive, worldwide license from JHU and IOCB for N-substituted prodrugs of Mebendazole, aimed at improved solubility and bioavailability[81](index=81&type=chunk) - The agreement includes a **4.0%** royalty on net sales and tiered minimum annual royalty payments starting in 2026, with no accrued expense as of June 30, 2025[81](index=81&type=chunk) [9. Subsequent Events](index=18&type=section&id=9.%20Subsequent%20Events) This section reports on significant events occurring after the reporting period, specifically common stock sales - Subsequent to June 30, 2025, the company raised approximately **$710,000** in gross proceeds from common stock sales under its ATM Agreement[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of financial condition and results, highlighting AI/ML drug development and liquidity challenges - The company's core business is advanced AI/ML analysis of complex data in medicine, utilizing its bfLEAP™ platform to accelerate drug development[87](index=87&type=chunk)[89](index=89&type=chunk) - The company continues to face liquidity challenges, with current cash insufficient to fund operations for the next year, necessitating additional capital raising efforts[97](index=97&type=chunk)[98](index=98&type=chunk) [Overview](index=20&type=section&id=Overview) This section provides an overview of the company's business, strategic initiatives, and current liquidity status - Bullfrog AI Holdings, Inc. focuses on advanced AI/ML analysis in medicine, utilizing its bfLEAP™ platform to improve drug development success and rescue late-stage failed drugs[87](index=87&type=chunk)[89](index=89&type=chunk)[91](index=91&type=chunk) - Key initiatives include investor relations, research and development, collaborations (e.g., J Craig Venter Institute, Lieber Institute for Brain Development), and preclinical studies for in-licensed drug programs[93](index=93&type=chunk)[94](index=94&type=chunk) - The company's cash balance of approximately **$2.6 million** as of June 30, 2025, is insufficient to fund planned operations for at least a year, raising substantial doubt about its ability to continue as a going concern[97](index=97&type=chunk) [Our Strategy](index=22&type=section&id=Our%20Strategy) This section outlines the company's dual strategy of partnerships and in-licensing drugs for AI/ML-driven development - The company's strategy involves generating revenue through strategic partnerships with biopharma companies for AI/ML analysis, structured with fees in cash, equity, or intellectual property[99](index=99&type=chunk) - A secondary strategy involves acquiring rights to drugs at various development stages, using proprietary AI/ML technology to advance and monetize them, preferably within approximately **30 months**[100](index=100&type=chunk) [Critical Accounting Policies and Estimates](index=22&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section discusses the key accounting policies and estimates used in preparing the company's financial statements - The company's financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that are evaluated on an ongoing basis[101](index=101&type=chunk) - There have been no material changes to the company's critical accounting policies and estimates as described in its Form 10-K[101](index=101&type=chunk) [Financial Operations Overview](index=22&type=section&id=Financial%20Operations%20Overview) This section provides an overview of the company's revenue, cost of revenue, and operating expenses - The company recognized its first commercial service contract revenue in Q3 2023 and approximately **$33,000** in Q2 2025 from a collaboration agreement with Eleison Pharmaceuticals Inc[102](index=102&type=chunk) - Research and development costs and general and administrative expenses are anticipated to increase in the future to support service offerings and clinical/pre-clinical activities[104](index=104&type=chunk)[105](index=105&type=chunk) [Revenue](index=22&type=section&id=Revenue) This section details the company's revenue recognition from its first commercial service contracts - The company recognized **$65,000** in revenue from its first commercial service contract in Q3 2023 and approximately **$33,000** in Q2 2025 from a collaboration agreement[102](index=102&type=chunk) [Cost of Revenue](index=23&type=section&id=Cost%20of%20Revenue) This section describes the components of cost of revenue, primarily personnel and third-party consultant costs - Cost of revenue primarily consists of internal personnel and third-party consultants directly attributable to satisfying performance obligations under revenue arrangements[103](index=103&type=chunk) [Research and Development Costs and Expenses](index=23&type=section&id=Research%20and%20Development%20Costs%20and%20Expenses) This section outlines the nature of R&D expenses, including licensed drug candidates and bfLEAP™ development - Research and development expenses include costs for licensed drug candidates, discovery efforts, collaborations, and internal personnel developing bfLEAP™ offerings[104](index=104&type=chunk) - R&D costs are expensed as incurred and are anticipated to become significant as the company executes its business plan, including preclinical research and IND application efforts[104](index=104&type=chunk) [General and Administrative Expenses](index=23&type=section&id=General%20and%20Administrative%20Expenses) This section details G&A expenses, including personnel, public company costs, and business development efforts - General and administrative expenses include personnel costs, public company expenses (D&O insurance, audit, legal, exchange listing), and business development, investor relations, and marketing efforts[105](index=105&type=chunk) - G&A expenses are expected to increase in the future to support service offerings and clinical/pre-clinical research and development activities[105](index=105&type=chunk) [Results of Operations - Comparison of Three Months Ended June 30, 2025 and 2024](index=23&type=section&id=Results%20of%20Operations%20-%20Comparison%20of%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares the company's financial performance for the three months ended June 30, 2025 and 2024 - The company recognized approximately **$33,000** in collaboration revenue and **$27,000** in cost of revenue for the three months ended June 30, 2025, with no comparable activity in the prior year[106](index=106&type=chunk) Operating Expenses (Three Months Ended June 30) | Operating Expense | June 30, 2025 | June 30, 2024 | Net Change | | :------------------------ | :------------ | :------------ | :--------- | | Research and development | $480,297 | $513,699 | $(33,402) | | General and administrative | $995,898 | $1,168,264 | $(172,366) | | **Total operating expenses** | **$1,476,195** | **$1,681,963** | **$(205,768)** | [Collaboration Revenue and Cost of Collaboration Revenue](index=23&type=section&id=Collaboration%20Revenue%20and%20Cost%20of%20Collaboration%20Revenue) This section compares collaboration revenue and associated costs for the three months ended June 30 Collaboration Revenue and Cost (Three Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | | Collaboration Revenue | $33,257 | $- | | Cost of Collaboration Revenue | $26,735 | $- | [Operating expenses](index=23&type=section&id=Operating%20expenses) This section compares total operating expenses for the three months ended June 30, including R&D and G&A Operating Expenses (Three Months Ended June 30) | Operating Expense | June 30, 2025 | June 30, 2024 | Net Change | | :------------------------ | :------------ | :------------ | :--------- | | Research and development | $480,297 | $513,699 | $(33,402) | | General and administrative | $995,898 | $1,168,264 | $(172,366) | | **Total operating expenses** | **$1,476,195** | **$1,681,963** | **$(205,768)** | [Research and Development](index=23&type=section&id=Research%20and%20Development) This section details the changes in research and development expenses for the three months ended June 30 - Research and development expenses decreased by **$33,402** for the three months ended June 30, 2025, primarily due to a reduction in personnel costs, partially offset by increased target discovery and validation efforts[107](index=107&type=chunk)[108](index=108&type=chunk) [General and Administrative](index=23&type=section&id=General%20and%20Administrative) This section details the changes in general and administrative expenses for the three months ended June 30 - General and administrative expenses decreased by **$172,366** for the three months ended June 30, 2025, primarily due to reductions in director and officer insurance policy premiums and non-cash stock-based compensation expense[107](index=107&type=chunk)[109](index=109&type=chunk) [Other Income (Expense), Net](index=24&type=section&id=Other%20Income%20(Expense)%2C%20Net) This section compares other income and expense, primarily interest income, for the three months ended June 30 Interest Income (Three Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | | Interest income | $23,393 | $78,216 | - Interest income decreased by approximately **$55,000** for the three months ended June 30, 2025, primarily due to a decrease in the company's average cash balance[110](index=110&type=chunk) [Results of Operations – Comparison of Six Months Ended June 30, 2025 and 2024](index=24&type=section&id=Results%20of%20Operations%20%E2%80%93%20Comparison%20of%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares the company's financial performance for the six months ended June 30, 2025 and 2024 - The company recognized approximately **$33,000** in collaboration revenue and **$27,000** in cost of revenue for the six months ended June 30, 2025, with no comparable activity in the prior year[111](index=111&type=chunk) Operating Expenses (Six Months Ended June 30) | Operating Expense | June 30, 2025 | June 30, 2024 | Net Change | | :------------------------ | :------------ | :------------ | :--------- | | Research and development | $1,056,557 | $1,065,825 | $(9,268) | | General and administrative | $2,476,258 | $2,581,856 | $(105,598) | | **Total operating expenses** | **$3,532,815** | **$3,647,681** | **$(114,866)** | [Collaboration Revenue and Cost of Collaboration Revenue](index=24&type=section&id=Collaboration%20Revenue%20and%20Cost%20of%20Collaboration%20Revenue) This section compares collaboration revenue and associated costs for the six months ended June 30 Collaboration Revenue and Cost (Six Months Ended June 30) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | | Collaboration Revenue | $33,257 | $- | | Cost of Collaboration Revenue | $26,735 | $- | [Operating expenses](index=24&type=section&id=Operating%20expenses) This section compares total operating expenses for the six months ended June 30, including R&D and G&A Operating Expenses (Six Months Ended June 30) | Operating Expense | June 30, 2025 | June 30, 2024 | Net Change | | :------------------------ | :------------ | :------------ | :--------- | | Research and development | $1,056,557 | $1,065,825 | $(9,268) | | General and administrative | $2,476,258 | $2,581,856 | $(105,598) | | **Total operating expenses** | **$3,532,815** | **$3,647,681** | **$(114,866)** | [Research and Development](index=24&type=section&id=Research%20and%20Development) This section details the changes in research and development expenses for the six months ended June 30 - Research and development expenses decreased by **$9,268** for the six months ended June 30, 2025, primarily due to a reduction in personnel costs, partially offset by increased target discovery and validation efforts[112](index=112&type=chunk)[113](index=113&type=chunk) [General and Administrative](index=24&type=section&id=General%20and%20Administrative) This section details the changes in general and administrative expenses for the six months ended June 30 - General and administrative expenses decreased by **$105,598** for the six months ended June 30, 2025, primarily due to reductions in D&O insurance policy premiums and recruiting fees, partially offset by increased personnel costs[112](index=112&type=chunk)[114](index=114&type=chunk) [Other Income (Expense), Net](index=24&type=section&id=Other%20Income%20(Expense)%2C%20Net) This section compares other income and expense, primarily interest income, for the six months ended June 30 Interest Income (Six Months Ended June 30) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | | Interest income | $63,475 | $143,413 | - Interest income decreased by approximately **$80,000** for the six months ended June 30, 2025, primarily due to a decrease in the company's average cash balance[115](index=115&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, capital needs, and efforts to secure additional funding - As of June 30, 2025, the company has an accumulated deficit of approximately **$20.3 million**[116](index=116&type=chunk) - The company's cash and cash equivalents position of **$2.6 million** as of June 30, 2025, is not sufficient to fund planned operations for at least a year, raising substantial doubt about its ability to continue as a going concern[120](index=120&type=chunk) - The company plans to seek additional capital through equity sales, debt, licensing, and collaborative arrangements, but there is no assurance of sufficient funding[120](index=120&type=chunk) [Consolidated Cash Flow Data](index=25&type=section&id=Consolidated%20Cash%20Flow%20Data) This section summarizes cash flows from operating, investing, and financing activities for the six-month periods Consolidated Cash Flow Data (Six Months Ended June 30) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(3,230,098) | $(3,132,149) | $(97,949) | | Net cash provided by financing activities | $372,750 | $6,121,507 | $(5,748,757) | | Net (decrease) increase in cash and cash equivalents | $(2,857,348) | $2,989,358 | $(5,846,706) | [Cash Flows Used in Operating Activities](index=25&type=section&id=Cash%20Flows%20Used%20in%20Operating%20Activities) This section details the changes in cash used for operating activities for the six months ended June 30 - Net cash used in operating activities increased by **$97,949** for the six months ended June 30, 2025, primarily due to payments of vendor payables, partially offset by a reduction in prepaid D&O insurance premiums[121](index=121&type=chunk)[122](index=122&type=chunk) [Cash Flows Used in Investing Activities](index=25&type=section&id=Cash%20Flows%20Used%20in%20Investing%20Activities) This section reports on the absence of cash flows from investing activities for the six months ended June 30 - There was no cash used in investing activities during the six months ended June 30, 2025 or 2024[123](index=123&type=chunk) [Cash Flows Provided by Financing Activities](index=25&type=section&id=Cash%20Flows%20Provided%20by%20Financing%20Activities) This section details the changes in cash flows from financing activities for the six months ended June 30 - Net cash provided by financing activities decreased by approximately **$5.75 million** for the six months ended June 30, 2025, primarily due to lower proceeds from secondary offerings and reduced D&O insurance financing, partially offset by proceeds from ATM common stock sales[121](index=121&type=chunk)[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing market risk disclosures - The company is exempt from providing quantitative and qualitative disclosures about market risk as it is a smaller reporting company[125](index=125&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to unremediated material weaknesses, with ongoing remediation efforts - Disclosure controls and procedures were not effective as of June 30, 2025, due to unremediated material weaknesses in internal control over financial reporting[126](index=126&type=chunk)[127](index=127&type=chunk) - Remediation efforts include transitioning accounting processes to an external firm, completing transfer to an enterprise accounting platform, reviewing control design, hiring a Corporate Controller, and engaging a third-party specialist[128](index=128&type=chunk)[130](index=130&type=chunk) - Despite the identified material weaknesses, management concluded that the unaudited condensed consolidated financial statements fairly present the financial position, results of operations, and cash flows[126](index=126&type=chunk) [Evaluation of Disclosure Controls and Procedures](index=26&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section details management's conclusion on the effectiveness of disclosure controls and procedures - Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025, due to previously identified material weaknesses in internal control over financial reporting[126](index=126&type=chunk) - Notwithstanding the material weaknesses, management believes the unaudited condensed consolidated financial statements fairly present the company's financial position, results of operations, and cash flows[126](index=126&type=chunk) [Material Weakness and Ongoing Remediation Efforts](index=26&type=section&id=Material%20Weakness%20and%20Ongoing%20Remediation%20Efforts) This section describes the unremediated material weaknesses and the company's ongoing remediation efforts - Material weaknesses in internal controls over financial reporting, identified at December 31, 2023, remain unremediated as of June 30, 2025, specifically regarding the documentation, implementation, and operation of effective controls[127](index=127&type=chunk) - Remediation efforts include transitioning day-to-day accounting processes to an external firm, completing the transfer to an enterprise accounting platform, reviewing control design, hiring a Corporate Controller, and engaging a third-party specialist[128](index=128&type=chunk)[130](index=130&type=chunk) [Changes in Internal Control Over Financial Reporting](index=26&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This section reports on any material changes in internal control over financial reporting during the quarter - Other than the material weakness remediation efforts, there have been no material changes in the company's internal control over financial reporting during the most recent quarter[129](index=129&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, equity sales, defaults, insider trading, and exhibits [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings material to its financial condition or operations - The company is not currently a party to any legal proceedings deemed material to its financial condition or results of operations[131](index=131&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, the company is not required to provide risk factor disclosures - Smaller reporting companies are not required to provide the information required by this item[132](index=132&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the six months ended June 30, 2025 - There were no unregistered sales of equity securities during the six months ended June 30, 2025[133](index=133&type=chunk) [Item 3. Defaults Upon Senior Securities](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[134](index=134&type=chunk) [Item 4. Mine Safety Disclosures](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[135](index=135&type=chunk) [Item 5. Other Information](index=27&type=section&id=Item%205.%20Other%20Information) This section discloses insider trading arrangements, specifically detailing the 10b5-1 sales plan of the CEO - During the quarter ended June 30, 2025, none of the company's directors or executive officers adopted, modified, or terminated any new insider trading arrangements[136](index=136&type=chunk) - The CEO, Vininder Singh, continues to operate under a 10b5-1 sales plan, under which **50,000** shares were sold in Q2 2025[136](index=136&type=chunk) [(c) Insider Trading Arrangements](index=27&type=section&id=(c)%20Insider%20Trading%20Arrangements) This section details the CEO's 10b5-1 sales plan and reports no new insider trading arrangements - No new insider trading arrangements were adopted, modified, or terminated by directors or executive officers during the quarter ended June 30, 2025[136](index=136&type=chunk) - The CEO's 10b5-1 sales plan, established in June 2023, provides for the sale of up to **1,000,000** shares of common stock by August 31, 2025, with **50,000** shares sold in Q2 2025[136](index=136&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications and XBRL documents - Key exhibits include the At-The-Market Sales Agreement (Exhibit 1.1), CEO/CFO certifications (Exhibits 31.1, 31.2, 32.1, 32.2), and Inline XBRL documents (Exhibits 101.INS to 101.PRE, and 104)[137](index=137&type=chunk)
BullFrog AI to Present at BTIG Annual Virtual Biotechnology Conference
Globenewswire· 2025-07-28 20:30
Core Insights - BullFrog AI Holdings, Inc. is participating in BTIG's Annual Virtual Biotechnology Conference, highlighting its focus on AI-driven drug development [1][2] Company Overview - BullFrog AI utilizes artificial intelligence and machine learning to enhance drug discovery and development processes [3] - The company collaborates with leading research institutions and employs its proprietary bfLEAP™ platform to analyze complex biological data, aiming to streamline therapeutic development and reduce clinical trial failure rates [3] Event Participation - CEO Vin Singh will engage in a fireside chat and one-on-one meetings during the conference scheduled for July 29-30, 2025 [1][2] - The fireside presentation is set for July 30, 2025, at 11:20 a.m. ET, with access available through BTIG [2]
Rethinking R&D: BullFrog AI White Paper Outlines New Blueprint for Smarter Drug Development
Globenewswire· 2025-07-22 12:00
Core Insights - BullFrog AI's bfLEAP™ platform aims to improve drug discovery success rates in a market where nearly 90% of drug candidates fail in clinical trials [1][2][4] - The company emphasizes a biology-native AI framework that provides transparency and causality in its analytics, contrasting with traditional black-box AI models [2][3] Company Overview - BullFrog AI Holdings, Inc. is a technology-enabled drug development company utilizing AI and machine learning to enhance pharmaceutical and biologic development [1][7] - The company has developed bfLEAP™, a proprietary platform designed to handle complex biomedical data and improve therapeutic decision-making [1][2] Market Positioning - The AI in drug discovery market is projected to exceed $35 billion by 2034, positioning BullFrog AI's bfLEAP™ as a leading solution that offers scientific clarity beyond mere automation [3] - The platform is part of BullFrog's broader Data Networks™ Solutions Library, which includes tools like bfPREP™ for data preparation [3][4] Technological Differentiation - bfLEAP™ is built to address the challenges of "short and wide" datasets and biological non-linearity, providing actionable insights throughout the drug development lifecycle [2][3] - The platform employs causal AI and combinatorial modeling to manage high-dimensional data effectively, correcting misleading patterns in biological datasets [2][3] Application in Drug Development - In early discovery, bfLEAP™ helps identify targets with high mechanistic potential based on molecular data [6] - During preclinical and Phase I trials, it detects subpopulations likely to respond to treatment, and in late-stage trials, it stratifies patients by genetic and behavioral variables [6]
Join BullFrog AI’s Exclusive Live Investor Webinar and Q&A Session on July 23
Globenewswire· 2025-07-18 13:00
Core Insights - BullFrog AI Holdings, Inc. is hosting a webinar on July 23, 2025, to discuss its advancements in drug development using AI and machine learning [1][2] - The company has launched the BullFrog Data Networks™ Solutions Library, which includes the bfLEAP™ causal AI engine and the new bfPREP™ module for data automation [2] - BullFrog AI is collaborating with Sygnature Discovery to enhance its global reach and drive revenue growth in the $204 billion biopharma R&D market [2] Company Overview - BullFrog AI utilizes AI and machine learning to improve drug discovery and development processes [5] - The company aims to reduce clinical trial failure rates by analyzing complex biological data through its proprietary platforms [5] Webinar Details - The webinar will feature insights from BullFrog AI's Founder and CEO, Vin Singh, followed by a live Q&A session [2][3] - Registration for the free webinar is available online [4]
BullFrog AI Launches bfPREP, a New AI-Powered Data Preparation Module in Its BullFrog Data Networks Solutions Library
Globenewswire· 2025-07-17 12:00
Core Insights - BullFrog AI Holdings, Inc. has introduced bfPREP™, a data cleansing and preparation module aimed at addressing the multi-billion-dollar data quality challenge in life sciences by automating data processes for AI readiness [1][3] Industry Overview - The global market for data preparation and cleansing tools in life sciences and healthcare is projected to grow from approximately $3.1 billion in 2024 to $6.8 billion by 2029, driven by increasing data volumes and demand for AI-ready infrastructure [3] Product Features - bfPREP™ automates the detection, correction, standardization, and transformation of clinical, omics, and real-world datasets, converting raw information into analysis-ready insights [2][3] - The module is designed for end-to-end automation, significantly reducing data preparation timelines from months to days [5] - It supports standards-based interoperability, with native support for OMOP and plans for additional healthcare data standards [5] Strategic Value - bfPREP™ is tailored for various stakeholders in drug development, including clinical operations teams, contract research organizations (CROs), biotechs, and health IT managers, enhancing their ability to deliver cleaner, submission-ready data faster [5][6] - The solution integrates seamlessly with existing data lakes and supports hybrid environments, making it scalable and cloud-ready [5]