Bone Biologics (BBLG) - 2025 Q2 - Quarterly Report

General Information Form 10-Q Filing Details Confirms the Q2 2025 Form 10-Q filing by Bone Biologics Corporation, a non-accelerated and smaller reporting company - The report is a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2] - Bone Biologics Corporation is a non-accelerated filer and a smaller reporting company[6][7] - The registrant has filed all required reports during the preceding 12 months and has been subject to filing requirements for the past 90 days[4] Securities and Shares Outstanding The Company's common stock and warrants are listed on Nasdaq, with 1,795,260 shares outstanding as of August 14, 2025 Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :--- | :--- | :--- | | Common stock, $0.001 par value per share | BBLG | The Nasdaq Capital Market | | Warrants to Purchase Common stock, $0.001 par value per share | BBLGW | The Nasdaq Capital Market | - As of August 14, 2025, there were 1,795,260 shares of the issuer's common stock, $0.001 par value, outstanding[8] Note on Forward-Looking Statements Forward-Looking Statements Disclaimer Cautions that forward-looking statements in the Form 10-Q are subject to risks and uncertainties, and actual results may differ materially - The Form 10-Q contains forward-looking statements based on current expectations and projections, which are subject to risks and uncertainties that could cause actual results to differ materially[12] - Key risks include the ability to raise additional capital, inflation, rising interest rates, regulatory authorization (FDA PMA), successful clinical trials, patent success, reliance on third-party manufacturers, market acceptance, and product liability claims[13] - The Company undertakes no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law[14] PART I – FINANCIAL INFORMATION Item 1. Financial Statements Presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, cash flows, and detailed notes Unaudited Condensed Consolidated Balance Sheets Balance sheets show significant increases in cash and total assets from December 2024 to June 2025, driven by financing activities Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash | $6,640,468 | $3,325,131 | | Total current assets | $7,002,216 | $3,861,369 | | Total assets | $7,002,216 | $3,861,369 | | Total current liabilities | $406,142 | $377,712 | | Total liabilities | $406,142 | $377,712 | | Total stockholders' equity | $6,596,074 | $3,483,657 | Unaudited Condensed Consolidated Statements of Operations No revenues reported. Net loss decreased for Q2 2025 but increased for the six-month period, influenced by operating expenses and warrant liability Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 (unaudited) | 2024 (unaudited) | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $ - | $ - | N/A | | Research and development | $191,608 | $350,442 | (45.32)% | | General and administrative | $556,467 | $459,223 | 21.18% | | Total operating expenses | $748,075 | $809,665 | (7.61)% | | Loss from operations | $(748,075) | $(809,665) | (7.61)% | | Net Loss | $(740,519) | $(783,733) | (5.51)% | | Loss per share – basic and diluted | $(1.33) | $(4.02) | (66.92)% | Statements of Operations Highlights (Six Months Ended June 30) | Metric | 2025 (unaudited) | 2024 (unaudited) | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $ - | $ - | N/A | | Research and development | $615,186 | $596,067 | 3.21% | | General and administrative | $1,171,377 | $1,117,135 | 4.86% | | Total operating expenses | $1,786,563 | $1,713,202 | 4.28% | | Loss from operations | $(1,786,563) | $(1,713,202) | 4.28% | | Net Loss | $(1,757,611) | $(1,649,703) | 6.54% | | Loss per share – basic and diluted | $(3.23) | $(10.82) | (70.15)% | Unaudited Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity increased from $3.48 million to $6.60 million, driven by public offerings and ATM sales, partially offset by net losses Stockholders' Equity Changes (Six Months Ended June 30, 2025) | Item | Shares | Common Stock Amount | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders' Equity | | :--- | :--- | :--- | :--- | :--- | :--- | | Balance at Dec 31, 2024 | 492,417 | $492 | $88,504,543 | $(85,021,378) | $3,483,657 | | Issuance of common shares from ATM, net | 52,843 | $53 | $347,496 | - | $347,549 | | Proceeds from public offering, net | 793,750 | $794 | $4,351,998 | - | $4,352,792 | | Exercise of pre-funded warrants | 346,250 | $346 | $(346) | - | $0 | | Net Loss | - | - | - | $(1,757,611) | $(1,757,611) | | Balance at June 30, 2025 | 1,685,260 | $1,685 | $93,373,378 | $(86,778,989) | $6,596,074 | Unaudited Condensed Consolidated Statements of Cash Flows Cash used in operations decreased to $1.38 million, while financing cash increased to $4.70 million due to equity offerings Cash Flow Highlights (Six Months Ended June 30) | Metric | 2025 (unaudited) | 2024 (unaudited) | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,385,004) | $(2,199,276) | | Net cash provided by financing activities | $4,700,341 | $1,504,775 | | Net increase (decrease) in cash | $3,315,337 | $(694,501) | | Cash, end of period | $6,640,468 | $2,332,068 | - The decrease in cash used in operating activities in 2025 was primarily due to a legal settlement payment in January 2024 that did not reoccur[145] - Cash provided by financing activities in 2025 resulted from net proceeds from the ATM Facility, a public offering, and the exercise of pre-funded warrants[146] Notes to Unaudited Condensed Consolidated Financial Statements These notes detail the Company's business, accounting policies, R&D, warrant liability, equity, stock compensation, segments, commitments, and subsequent events Note 1. The Company Bone Biologics develops NELL-1/DBM for spinal fusion, facing FDA PMA and going concern issues, with recent financing extending its cash runway - The Company is a medical device company focused on bone regeneration in spinal fusion using the recombinant human protein NELL-1 in combination with DBM[39] - NELL-1/DBM is classified as a device/drug combination product requiring an FDA-approved pre-market approval (PMA) application[39] - As of June 30, 2025, the Company has incurred accumulated losses of approximately $86.8 million, raising substantial doubt about its ability to continue as a going concern[43] - Estimated operating expenditures for the next twelve months are $6.8 million[43] - At June 30, 2025, the Company had cash of $6.6 million, expected to fund operations into the second quarter of 2026[45] - A 1-for-6 reverse stock split of its outstanding common stock and warrants was effective on June 10, 2025[47] Note 2. Summary of Significant Accounting Policies This note outlines key accounting policies: single segment, R&D costs, Level 3 warrant liability, stock compensation, and new accounting standards - The Company operates and reports in one segment, focused on bone regeneration in spinal fusion using NELL-1[51] - Research and development costs are generally charged to operations ratably over contract life or as incurred for non-refundable payments[58] - The warrant liability is measured at fair value on a recurring basis using unobservable Level 3 inputs[62][63] - Outstanding options and warrants were anti-dilutive for the six months ended June 30, 2025 and 2024, and thus excluded from loss per common share computation[69] - The Company is evaluating the impact of new accounting standards: ASU 2024-03 (Expense Disaggregation Disclosures), ASU 2024-04 (Debt with Conversion and Other Options), and ASU 2023-09 (Income Taxes: Improvements to Income Tax Disclosures)[70][71][72] Note 3. Research and Development R&D efforts include a pilot clinical study of NB1 bone graft in Australia; R&D costs slightly increased for the six months - The Company is conducting a multicenter, prospective, randomized pilot clinical study of its NB1 bone graft device in Australia, evaluating safety and effectiveness in up to 30 adult subjects for degenerative disc disease[76][77] Research and Development Costs (Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Total R&D Costs | $615,186 | $596,067 | | United States | $416,259 | $433,483 | | Australia | $198,927 | $162,584 | - The estimated remaining commitment under R&D agreements is approximately $268,105 as of June 30, 2025[78] Note 4. Warrant Liability Warrant liability from a 2022 offering is re-measured at fair value using Black-Scholes, decreasing from $4,670 to $2,413 by June 30, 2025 - Warrants issued in October 2022 are classified as a liability and re-measured at fair value due to a Black-Scholes value calculation provision that introduces leverage[81] Warrant Liability Fair Value | Date | Fair Value | | :--- | :--- | | June 30, 2025 | $2,413 | | December 31, 2024 | $4,670 | - The change in fair value of warrant liability for the six months ended June 30, 2025, was $(2,257)[65] Note 5. Stockholders' Equity Common stock outstanding significantly increased due to a June 2025 public offering and ATM sales, generating $4.35 million in net proceeds Common Stock Outstanding | Date | Shares Outstanding | | :--- | :--- | | June 30, 2025 | 1,685,260 | | December 31, 2024 | 492,417 | - In June 2025, the Company completed a public offering, issuing common stock, pre-funded warrants, and Series D and E warrants, resulting in net proceeds of $4,352,792[85] - Through its ATM Offering Program, the Company sold 52,843 shares of common stock for net proceeds of $347,549 during the six months ended June 30, 2025[88] Note 6. Common Stock Warrants Warrant activity for H1 2025 shows a substantial increase in issued warrants and exercises, resulting in 2,994,037 outstanding warrants Common Stock Warrant Activity (Six Months Ended June 30, 2025) | Metric | Number of Warrants | | :--- | :--- | | Outstanding as of December 31, 2024 | 309,037 | | Issued – 2025 | 3,031,250 | | Exercised – 2025 | (346,250) | | Outstanding as of June 30, 2025 | 2,994,037 | - As of June 30, 2025, the intrinsic value attributed to exercisable but unexercised in-the-money common stock warrants was $519,897[93] Note 7. Stock-based Compensation The 2015 Equity Incentive Plan was amended to increase shares by 5,000,000; stock-based compensation expense increased to $123,504 for H1 2025 - In May 2025, stockholders approved an amendment to the 2015 Equity Incentive Plan, increasing the number of shares available by 5,000,000[94] Stock Option Activity (Six Months Ended June 30, 2025) | Metric | Number of Options | | :--- | :--- | | Outstanding as of December 31, 2024 | 32,434 | | Granted – 2025 | 55,461 | | Outstanding as of June 30, 2025 | 87,856 | Stock-based Compensation Expense (Six Months Ended June 30) | Period | Expense | | :--- | :--- | | 2025 | $123,504 | | 2024 | $70,124 | - As of June 30, 2025, total unrecognized compensation cost related to unvested stock options was $164,612, expected to be recognized over a weighted average period of 0.63 years[101] Note 8. Segment information The Company operates as a single segment, with the CEO and President serving as CODM, evaluating financial performance on a consolidated basis - The Company operates and reports in one segment, focused on bone regeneration in spinal fusion using NELL-1[51][102] - The Chief Operating Decision Maker (CODM) is the Company's Chief Executive Officer and President, who uses consolidated net income (loss) as the sole measure of segment profit or loss[51][52][102] Note 9. Commitments and Contingencies The Company holds an exclusive NELL-1 license with UCLA TDG, involving annual fees, sales royalties, and significant milestone payments - The Company has an Amended and Restated Exclusive License Agreement with UCLA TDG for exclusive rights to develop and commercialize NELL-1 for spinal fusion, osteoporosis, and trauma applications[104] - Key financial obligations under the license include an annual maintenance fee of $10,000, royalties of 3.0% of net sales, and milestone payments[105] UCLA TDG Milestone Payments | Milestone Event | Payment | | :--- | :--- | | First subject enrollment in Feasibility Study | $100,000 | | First subject enrollment in Pivotal Study | $250,000 | | Pre-Market Approval | $500,000 | | First Commercial Sale | $1,000,000 | - The initial $100,000 Feasibility Study milestone was triggered in 2024 with the treatment of the first patients in the NB1 pilot clinical study[110] - A Diligence Fee of $8,000,000 is obligated upon cumulative Net Sales equaling $200,000,000 following the Triggering Sale Date[108][116] Note 10. Subsequent Events No additional subsequent events requiring adjustment or disclosure were noted through August 14, 2025 - No additional subsequent events requiring adjustment or disclosure were noted through August 14, 2025, the date the financial statements were available to be issued[115] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the Company's financial condition, operations, business focus, recent developments, operating expenses, net loss, liquidity, and capital resources Company Overview Bone Biologics is a clinical-stage medical device company developing NELL-1/DBM for spinal fusion, with NB1 in a pilot study in Australia - The Company is a medical device company focused on bone regeneration in spinal fusion using NELL-1 in combination with DBM[118] - The NB1 bone graft device is undergoing a multicenter, prospective, randomized pilot clinical study in Australia for degenerative disc disease[122][123] - In the second quarter of 2025, the Company submitted a patent application for proprietary compositions of rhNELL-1 polypeptide for treating bone conditions[121] Recent Developments Recent developments include regaining Nasdaq compliance, a 1-for-6 reverse stock split, and a June 2025 public offering to raise capital - The Company regained compliance with Nasdaq Listing Rule 5550(a)(2) (minimum bid price) on June 25, 2025[124] - A 1-for-6 reverse stock split of outstanding common stock became effective on June 10, 2025[125] - In June 2025, the Company completed a public offering, issuing common stock, pre-funded warrants, and Series D and E warrants[126] Results of Operations Q2 2025 R&D decreased, G&A increased, leading to net loss decrease; H1 2025 R&D and G&A increased, resulting in net loss increase Operating Expenses and Net Loss (Three Months Ended June 30) | Metric | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $191,608 | $350,442 | (45.32)% | | General and administrative | $556,467 | $459,223 | 21.18% | | Total operating expenses | $748,075 | $809,665 | (7.61)% | | Net loss | $(740,519) | $(783,733) | (5.51)% | - The decrease in R&D expenditures for the three months ended June 30, 2025, was attributed to the timing of the clinical trial[129] - The increase in G&A expenses for both periods was primarily due to the timing of compensation stock options issued to directors, with expense recognition occurring in Q2 2025 compared to Q3 2024[130][135] Operating Expenses and Net Loss (Six Months Ended June 30) | Metric | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Revenues | $ - | $ - | N/A | | Research and development | $615,186 | $596,067 | 3.21% | | General and administrative | $1,171,377 | $1,117,135 | 4.86% | | Total operating expenses | $1,786,563 | $1,713,202 | 4.28% | | Loss from operations | $(1,786,563) | $(1,713,202) | 4.28% | | Net Loss | $(1,757,611) | $(1,649,703) | 6.54% | | Loss per share – basic and diluted | $(3.23) | $(10.82) | (70.15)% | Liquidity and Capital Resources Accumulated losses raise going concern doubts, but $4.35 million from a June 2025 offering extends cash runway into Q2 2026 - The Company has incurred accumulated losses of approximately $86.8 million since inception to June 30, 2025, raising substantial doubt about its ability to continue as a going concern[138] - Estimated operating expenditures for the next twelve months are $6.8 million[138] - The June 2025 public offering generated net proceeds of $4,352,792[140] Cash Balance | Date | Cash | | :--- | :--- | | June 30, 2025 | $6,640,468 | | December 31, 2024 | $3,325,131 | - Available cash is expected to fund the Company's operations into the second quarter of 2026[144] Cash Flows Cash used in operations decreased to $1.38 million, while financing cash increased to $4.70 million due to equity offerings Cash Flows from Operating Activities (Six Months Ended June 30) | Period | Net Cash Used in Operating Activities | | :--- | :--- | | 2025 | $(1,385,004) | | 2024 | $(2,199,276) | - Cash provided by financing activities was $4,700,341 for the six months ended June 30, 2025, from the ATM Facility, public offering, and exercise of pre-funded warrants[146] Off-Balance Sheet Arrangements The Company has no material off-balance sheet arrangements significantly affecting its financial condition or results of operations - The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a material adverse effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources[147] Critical Accounting Policies and Use of Estimates No material changes to critical accounting policies and estimates from the Annual Report on Form 10-K for FY2024 - There have been no material changes to the Company's critical accounting policies and use of estimates discussed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024[148] Item 3. Quantitative and Qualitative Disclosures about Market Risk This item is not applicable to the Company - This item is not applicable to the Company[149] Item 4. Controls and Procedures Management concluded disclosure controls were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management concluded that the Company's disclosure controls and procedures were effective as of June 30, 2025[150] - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[152] PART II – OTHER INFORMATION Item 1. Legal Proceedings The Company is not party to any legal proceedings that would materially adversely affect its business or financial condition - The Company is not presently a party to any legal proceedings that, if determined adversely, would have a material adverse effect on its business, results of operations, financial condition, or cash flows[154] Item 1A. Risk Factors For risks, refer to the FY2024 Form 10-K; no material changes from previously disclosed risk factors are noted herein - For a discussion of potential risks or uncertainties, refer to 'Part I—Item 1A—Risk Factors' and 'Part II—Item 7—Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[155] - There have been no material changes from the risk factors as previously disclosed in the Annual Report on Form 10-K, except as noted herein[155] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The Company reported no unregistered sales of equity securities or use of proceeds during the period - None[156] Item 3. Defaults Upon Senior Securities The Company reported no defaults upon senior securities during the period - None[156] Item 4. Mine Safety Disclosures This item is not applicable to the Company - Not Applicable[156] Item 5. Other Information No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during Q2 2025 - During the three months ended June 30, 2025, no director or officer of the Company adopted or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement'[156] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, warrant forms, and SOX certifications - Exhibits include the Certificate of Amendment to the Amended and Restated Certificate of Incorporation, various forms of Series D, Series E, Pre-Funded, and Placement Agent Warrants, and certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[159] Signatures Report Signatures The Form 10-Q report was signed by Jeffrey Frelick, CEO of Bone Biologics Corporation, on August 14, 2025 - The report was signed by Jeffrey Frelick, Chief Executive Officer of Bone Biologics Corporation, on August 14, 2025[164]