Bone Biologics (US:BBLG)2025-05-12 21:00PART I – FINANCIAL INFORMATION Item 1. Financial Statements The company reported no revenue, a net loss of $1.02 million, and a significant going concern issue Unaudited Condensed Consolidated Balance Sheets Total assets decreased to $3.16 million, driven by a reduction in cash, while stockholders' equity declined Condensed Consolidated Balance Sheet Data (unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash | $2,746,555 | $3,325,131 | | Total current assets | $3,162,060 | $3,861,369 | | Liabilities & Equity | | | | Total current liabilities | $251,158 | $377,712 | | Total stockholders' equity | $2,910,902 | $3,483,657 | | Total liabilities and stockholders' equity | $3,162,060 | $3,861,369 | Unaudited Condensed Consolidated Statements of Operations The company generated no revenue and reported a net loss of $1.02 million, an increase from the prior year Statement of Operations Summary (unaudited) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Research and development | $423,576 | $245,625 | | General and administrative | $614,910 | $657,911 | | Loss from operations | ($1,038,486) | ($903,536) | | Net loss | ($1,017,092) | ($865,970) | | Loss per share - basic and diluted | ($0.32) | ($1.31) | Unaudited Condensed Consolidated Statements of Cash Flows Net cash used in operations was $0.93 million, with financing activities providing $0.35 million Cash Flow Summary (unaudited) | Cash Flow Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($926,125) | ($1,303,411) | | Net cash provided by financing activities | $347,549 | $1,504,476 | | Net increase (decrease) in cash | ($578,576) | $201,065 | | Cash, end of period | $2,746,555 | $3,227,634 | Notes to Unaudited Condensed Consolidated Financial Statements Notes detail the company's product focus, regulatory hurdles, and a critical going concern disclosure - The company is a medical device firm focused on bone regeneration in spinal fusion using the recombinant human protein NELL-1, which requires an FDA-approved PMA application before commercialization36 - The company has an accumulated deficit of approximately $86.0 million as of March 31, 2025, and has incurred a net loss of $1.0 million for the quarter, raising substantial doubt about its ability to continue as a going concern40 - As of March 31, 2025, the company had $2.7 million in cash, which is expected to fund operations only up to the fourth quarter of 202541 - During Q1 2025, the company sold 317,060 shares of common stock through its At The Market (ATM) facility for net proceeds of $347,54976 - The company is obligated to make milestone payments to UCLA TDG, including $250,000 upon enrollment in a Pivotal Study, $500,000 upon Pre-Market Approval, and $1,000,000 upon First Commercial Sale949596 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses its clinical-stage status, a Nasdaq deficiency notice, and reiterates going concern doubts - On April 7, 2025, the company received a deficiency notice from Nasdaq for its common stock closing below the $1.00 minimum bid price for 30 consecutive business days112 - To address the Nasdaq deficiency, the company intends to seek stockholder approval for a reverse stock split at its annual meeting on May 30, 2025113 Results of Operations Comparison | Metric | Three-months ended Mar 31, 2025 | Three-months ended Mar 31, 2024 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $423,576 | $245,625 | 72.45% | | General and administrative | $614,910 | $657,911 | (6.54)% | | Net loss | ($1,017,092) | ($865,970) | 17.45% | - The increase in R&D costs is attributed to formulation processes completed with a Contract Development and Manufacturing Organization116 - The company reiterates the going concern warning, stating that its cash of $2.7 million as of March 31, 2025, is only expected to fund operations into the fourth quarter of 2025120122 Quantitative and Qualitative Disclosures about Market Risk The company has indicated that this item is not applicable - Not applicable127 Controls and Procedures Management concluded that disclosure controls and procedures were effective with no material changes in internal control - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective128 - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls129 PART II – OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings - The company is not presently a party to any material legal proceedings131 Risk Factors The company highlights risks from its Nasdaq non-compliance and the proposed reverse stock split - A new material risk is the company's non-compliance with the Nasdaq minimum bid price rule, which could result in delisting133 - Potential consequences of delisting include inability to raise equity capital, loss of partner confidence, price decrease, and loss of institutional investor interest135 - The proposed reverse stock split may not increase the stock price proportionally, may not be sustained, and could decrease the liquidity of the common stock134136 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None139 Other Information No Rule 10b5-1 trading plans were adopted or terminated, and the annual meeting date was changed - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025139 - The company's 2025 Annual Meeting will be held on May 30, 2025, a change of more than 30 days from the previous year's anniversary140 Exhibits This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files