Key accomplishments include expanded rhNELL-1 shelf life, advanced NB1 development, strengthened balance sheet, and maintained Nasdaq complianceBURLINGTON, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Bone Biologics Corporation ("Bone Biologics" or the "Company") (NASDAQ: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, today summarized key corporate, scientific, and operational milestones achieved during 2025 and outlined its strategic outlook for 2026. “We executed with discipline ...

Milestone advances manufacturing readiness and supports long-term commercialization strategyBURLINGTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Bone Biologics Corporation ("Bone Biologics" or the "Company") (NASDAQ: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, announces it has received confirmation that the shelf life of its rhNELL-1 product has been extended to 24 months, delivering on previously communicated forecasts. The extended shelf life is validated by ongoing stabi ...

Core Viewpoint - Venus Concept Inc. is facing a challenging market outlook with a significant potential downside in its stock price, while Bone Biologics Corporation shows a more optimistic scenario among its peers [1][5][6]. Group 1: Company Performance - Venus Concept Inc. is currently trading at $2.21, with a target price of $1.64, indicating a potential downside of approximately -25.65% [1][6]. - NanoVibronix, Inc. is trading at $4.02 with a market cap of $3.20 million, but has a negative EPS of -51.81 and a PE ratio of -4.73 [2][6]. - Bone Biologics Corporation trades at $2 with a market cap of $3.61 million, showing an EPS of -2.4 and a PE ratio of -2.08 [3][6]. Group 2: Market Sentiment - Bone Biologics Corporation exhibits the highest growth potential among its peers, with a price percentage difference of 9.32%, indicating a more favorable market sentiment [4][6]. - The significant gap between the current and target price of Venus Concept Inc. suggests a pessimistic outlook from investment analysts, leading to its exclusion from coverage [1][5].

Financial Performance - Total current assets increased to $6,350,799 as of September 30, 2025, compared to $3,861,369 on December 31, 2024, representing a growth of 64.3%[19] - Total stockholders' equity rose to $6,016,517 at September 30, 2025, up from $3,483,657 at December 31, 2024, indicating a 72.5% increase[19] - Net loss for the nine months ended September 30, 2025, was $2,424,348, a reduction of 6.4% compared to a net loss of $2,590,705 for the same period in 2024[34] - The loss per share attributable to common stockholders for the nine months ended September 30, 2025, was $2.51, a decrease from $29.09 in the same period of 2024[23] - The net loss for the three months ended September 30, 2025, was $666,737, a reduction of 29.15% from a net loss of $941,002 in the same period of 2024[129] - For the nine months ended September 30, 2025, total operating expenses decreased by 6.10% to $2,501,837 from $2,664,223 in the same period of 2024[134] Cash and Financing - Cash at the end of the period increased to $6,049,084 as of September 30, 2025, compared to $3,566,426 at September 30, 2024, reflecting an increase of 69.5%[34] - Cash used in operating activities for the nine months ended September 30, 2025, was $1,976,388, a decrease from $2,771,438 in the same period of 2024, primarily due to the absence of a legal settlement payment and lower R&D expenses[146] - Cash provided by financing activities during the nine months ended September 30, 2025, was $4,700,341, compared to $3,311,295 in the same period of 2024, driven by net proceeds from the ATM Facility and the June Offering[147] - The company raised $4,352,792 from the sale of common stock and warrants in a public offering during the nine months ended September 30, 2025[34] - The Company issued 793,750 shares of common stock and pre-funded warrants for $4.00 per share, resulting in net proceeds of $4,352,792 after cash costs[44] - The company expects its available cash to fund operations into the fourth quarter of 2026[145] Operating Expenses - Operating expenses for the three months ended September 30, 2025, were $715,274, a decrease of 24.8% from $951,021 in the same period of 2024[23] - For the three months ended September 30, 2025, total operating expenses decreased by 24.79% to $715,274 from $951,021 in the same period of 2024[129] - General and administrative expenses increased by 3.69% to $1,698,843 for the nine months ended September 30, 2025, compared to $1,638,409 in the same period of 2024[136] - Operating expenditures for the next twelve months are estimated at $6.9 million, raising substantial doubt about the Company's ability to continue as a going concern[43] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $802,994, down 21.7% from $1,025,814 in the same period of 2024[23] - Research and development expenses for the three months ended September 30, 2025, decreased by 56.30% to $187,808 compared to $429,747 for the same period in 2024[129] - The Company has an estimated remaining commitment of approximately $244,327 under agreements with Contract Manufacturing Organizations and Contract Research Organizations as of September 30, 2025[76] - The pilot clinical study for the NB1 bone graft device will evaluate safety and effectiveness in up to 30 adult subjects undergoing lumbar interbody fusion[75] Stock and Equity - The weighted average shares of common stock outstanding increased to 1,795,097 for the three months ended September 30, 2025, compared to 292,321 for the same period in 2024[23] - As of September 30, 2025, the Company had 1,795,260 shares of common stock outstanding, an increase from 492,417 shares as of December 31, 2024[82] - The company has 5,104,915 shares of common stock authorized for issuance under its 2015 Equity Incentive Plan, which was increased by 5,000,000 shares in May 2025[99] - The company issued stock options totaling 55,461 with an average exercise price of $5.41 during the nine months ended September 30, 2025[102] - As of September 30, 2025, the company had 2,884,037 outstanding common stock warrants with a weighted average exercise price of $13.59 and a weighted average life of 2.88 years[97] Regulatory and Market Conditions - The Company is subject to extensive regulation by the FDA, requiring rigorous preclinical and clinical testing before marketing its products in the U.S.[40] - The Company has experienced volatility and disruption in financial markets due to macroeconomic and geopolitical events, impacting its operations[42] - The Company plans to continue raising additional debt and/or equity financing to fund future operations, but there is no assurance that such financing will be obtained[46] Legal and Compliance - The company is not currently involved in any legal proceedings that would materially affect its business or financial condition[155] - There have been no material changes to the risk factors previously disclosed in the Annual Report for the year ended December 31, 2024[156] - The company has not experienced any material changes in its critical accounting policies since the last annual report[149] - As of September 30, 2025, the company's disclosure controls and procedures were evaluated as effective by management[151]

[General Information](index=1&type=section&id=General%20Information) [Form 10-Q Filing Details](index=1&type=section&id=Form%2010-Q%20Filing%20Details) 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](index=2&type=chunk) - Bone Biologics Corporation is a **non-accelerated filer** and a **smaller reporting company**[6](index=6&type=chunk)[7](index=7&type=chunk) - 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](index=4&type=chunk) [Securities and Shares Outstanding](index=1&type=section&id=Securities%20and%20Shares%20Outstanding) 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](index=8&type=chunk) [Note on Forward-Looking Statements](index=4&type=section&id=NOTE%20ON%20FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements Disclaimer](index=4&type=section&id=Forward-Looking%20Statements%20Disclaimer) 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](index=12&type=chunk) - 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](index=13&type=chunk) - 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](index=14&type=chunk) [PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements.) Presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, cash flows, and detailed notes [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) 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** | **$3,483,657** | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) No revenues reported. Net loss decreased for Q2 2025 but increased for the six-month period, influenced by operating expenses and warrant liability Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 (unaudited) | 2024 (unaudited) | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | **$ -** | **$ -** | 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](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) 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](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=145&type=chunk) - 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](index=146&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) 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](index=10&type=section&id=Note%201.%20The%20Company) 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](index=39&type=chunk) - NELL-1/DBM is classified as a device/drug combination product requiring an **FDA-approved pre-market approval (PMA) application**[39](index=39&type=chunk) - 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](index=43&type=chunk) - Estimated operating expenditures for the next **twelve months** are **$6.8 million**[43](index=43&type=chunk) - At June 30, 2025, the Company had cash of **$6.6 million**, expected to fund operations into the **second quarter of 2026**[45](index=45&type=chunk) - A **1-for-6 reverse stock split** of its outstanding common stock and warrants was effective on June 10, 2025[47](index=47&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=11&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) 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](index=51&type=chunk) - Research and development costs are generally charged to operations ratably over contract life or as incurred for non-refundable payments[58](index=58&type=chunk) - The warrant liability is measured at fair value on a recurring basis using unobservable **Level 3 inputs**[62](index=62&type=chunk)[63](index=63&type=chunk) - 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](index=69&type=chunk) - 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](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) [Note 3. Research and Development](index=17&type=section&id=Note%203.%20Research%20and%20Development) 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](index=76&type=chunk)[77](index=77&type=chunk) 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](index=78&type=chunk) [Note 4. Warrant Liability](index=17&type=section&id=Note%204.%20Warrant%20Liability) 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](index=81&type=chunk) 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](index=65&type=chunk) [Note 5. Stockholders' Equity](index=18&type=section&id=Note%205.%20Stockholders'%20Equity) 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](index=85&type=chunk) - 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](index=88&type=chunk) [Note 6. Common Stock Warrants](index=20&type=section&id=Note%206.%20Common%20Stock%20Warrants) 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](index=93&type=chunk) [Note 7. Stock-based Compensation](index=20&type=section&id=Note%207.%20Stock-based%20Compensation) 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](index=94&type=chunk) 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](index=101&type=chunk) [Note 8. Segment information](index=23&type=section&id=Note%208.%20Segment%20information) 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](index=51&type=chunk)[102](index=102&type=chunk) - 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](index=51&type=chunk)[52](index=52&type=chunk)[102](index=102&type=chunk) [Note 9. Commitments and Contingencies](index=23&type=section&id=Note%209.%20Commitments%20and%20Contingencies) 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](index=104&type=chunk) - 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](index=105&type=chunk) 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](index=110&type=chunk) - A Diligence Fee of **$8,000,000** is obligated upon cumulative Net Sales equaling **$200,000,000** following the Triggering Sale Date[108](index=108&type=chunk)[116](index=116&type=chunk) [Note 10. Subsequent Events](index=25&type=section&id=Note%2010.%20Subsequent%20Events) 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](index=115&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Company's financial condition, operations, business focus, recent developments, operating expenses, net loss, liquidity, and capital resources [Company Overview](index=26&type=section&id=Company%20Overview) 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](index=118&type=chunk) - The NB1 bone graft device is undergoing a multicenter, prospective, randomized pilot clinical study in Australia for degenerative disc disease[122](index=122&type=chunk)[123](index=123&type=chunk) - In the **second quarter of 2025**, the Company submitted a patent application for proprietary compositions of rhNELL-1 polypeptide for treating bone conditions[121](index=121&type=chunk) [Recent Developments](index=27&type=section&id=Recent%20Developments) 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](index=124&type=chunk) - A **1-for-6 reverse stock split** of outstanding common stock became effective on June 10, 2025[125](index=125&type=chunk) - In June 2025, the Company completed a public offering, issuing common stock, pre-funded warrants, and Series D and E warrants[126](index=126&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) 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)** | **$(783,733)** | **(5.51)%** | - The decrease in R&D expenditures for the **three months** ended June 30, 2025, was attributed to the timing of the clinical trial[129](index=129&type=chunk) - The increase in G&A expenses for both periods was primarily due to the timing of compensation stock options issued to directors, with expense recognition occurring in Q2 2025 compared to Q3 2024[130](index=130&type=chunk)[135](index=135&type=chunk) Operating Expenses and Net Loss (Six Months Ended June 30) | Metric | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Revenues | **$ -** | **$ -** | 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](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=138&type=chunk) - Estimated operating expenditures for the next **twelve months** are **$6.8 million**[138](index=138&type=chunk) - The June 2025 public offering generated net proceeds of **$4,352,792**[140](index=140&type=chunk) 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](index=144&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) 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](index=146&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) 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](index=147&type=chunk) [Critical Accounting Policies and Use of Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) 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](index=148&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not applicable to the Company - This item is not applicable to the Company[149](index=149&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=150&type=chunk) - 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](index=152&type=chunk) [PART II – OTHER INFORMATION](index=32&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=154&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) 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](index=155&type=chunk) - 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](index=155&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The Company reported no unregistered sales of equity securities or use of proceeds during the period - None[156](index=156&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - None[156](index=156&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - Not Applicable[156](index=156&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) 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](index=156&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) 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](index=159&type=chunk) [Signatures](index=35&type=section&id=SIGNATURES) [Report Signatures](index=35&type=section&id=Report%20Signatures) 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](index=164&type=chunk)

Core Insights - Bone Biologics Corporation's stock is experiencing an increase, with a trading volume of 17.22 million shares compared to an average of 38.795K shares [1] - The company has filed a patent application for its preclinical NELL-1 protein, aimed at treating bone conditions, particularly in spinal fusion procedures [2] - The patent application is seen as a significant step in the company's mission to provide effective treatments for spine fusion patients [2] Financial Activities - Bone Biologics has priced a public offering of 1.25 million shares along with Series D and Series E warrants, each with an exercise price of $4 per share [3] - The total gross proceeds from this offering are expected to be $5.0 million, with potential additional proceeds of $10 million if the warrants are fully exercised [4] - Proceeds from the offering will be allocated to fund clinical trials, maintain and extend the patent portfolio, and for general corporate purposes [4] Stock Performance - The company recently executed a reverse stock split at a ratio of 1-for-6 [5] - As of the latest publication, Bone Biologics' stock price has risen by 20.31%, reaching $5.01 [5]

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements.) The company reported no revenue, a net loss of $1.02 million, and a significant going concern issue [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) 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 commercialization[36](index=36&type=chunk) - 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 concern**[40](index=40&type=chunk) - 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 2025**[41](index=41&type=chunk) - During Q1 2025, the company sold 317,060 shares of common stock through its At The Market (ATM) facility for net proceeds of **$347,549**[76](index=76&type=chunk) - 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 Sale[94](index=94&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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 days[112](index=112&type=chunk) - To address the Nasdaq deficiency, the company intends to seek stockholder approval for a **reverse stock split** at its annual meeting on May 30, 2025[113](index=113&type=chunk) 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 Organization[116](index=116&type=chunk) - 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 2025[120](index=120&type=chunk)[122](index=122&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company has indicated that this item is not applicable - Not applicable[127](index=127&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) 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 **effective**[128](index=128&type=chunk) - **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 controls[129](index=129&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently a party to any material legal proceedings - The company is **not presently a party to any material legal proceedings**[131](index=131&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors.) 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 delisting[133](index=133&type=chunk) - Potential consequences of **delisting** include inability to raise equity capital, loss of partner confidence, price decrease, and loss of institutional investor interest[135](index=135&type=chunk) - The proposed **reverse stock split** may not increase the stock price proportionally, may not be sustained, and could decrease the liquidity of the common stock[134](index=134&type=chunk)[136](index=136&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[139](index=139&type=chunk) [Other Information](index=28&type=section&id=Item%205.%20Other%20Information) 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, 2025[139](index=139&type=chunk) - 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 anniversary[140](index=140&type=chunk) [Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files

Part I [Business](index=6&type=section&id=Item%201.%20Business) Bone Biologics is a clinical-stage medical device company focused on bone regeneration for spinal fusion, with its lead product NB1 in a pilot clinical study in Australia - The company is a medical device firm focused on bone regeneration in spinal fusion using the recombinant human protein **NELL-1**, licensed exclusively from UCLA TDG[18](index=18&type=chunk) - The lead product candidate, **NB1** (NELL-1/DBM), is in a pilot clinical study in Australia involving up to **30 subjects** to evaluate its safety and effectiveness in treating degenerative disc disease (DDD), with the first patients treated in **2024**[22](index=22&type=chunk)[23](index=23&type=chunk) - The FDA has classified the NELL-1/DBM product as a device/drug combination that will require a Pre-Market Approval (**PMA**) application for commercialization in the U.S[18](index=18&type=chunk)[39](index=39&type=chunk) Research and Development Expenses | Fiscal Year | R&D Expense ($) | | :--- | :--- | | 2024 | $2,130,385 | | 2023 | $6,907,824 | - The company holds exclusive licenses for **six U.S. patents** from UCLA TDG related to NELL-1, with expiration dates ranging from **2026 to 2033**[59](index=59&type=chunk) - The company has **two full-time employees** and relies heavily on independent organizations, advisors, and consultants for regulatory, clinical, and manufacturing functions[80](index=80&type=chunk) [Risk Factors](index=15&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks related to its financial position, early-stage product development, and heavy reliance on third parties and external funding - The company has a limited operating history, has incurred losses since inception (accumulated deficit of ~**$85.0 million**), and its recurring operating losses raise substantial doubt about its ability to continue as a going concern, with available cash expected to fund operations only up to **Q4 2025**[87](index=87&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - Product candidates are in an **early stage** of development, and the FDA regulatory process is costly, time-consuming, and uncertain, with the company's pilot clinical study in Australia potentially not accepted for a U.S. pivotal trial[96](index=96&type=chunk)[101](index=101&type=chunk) - The company relies on **third parties** for its core technology license (UCLA TDG), raw material supply, and to conduct preclinical and clinical trials, where failure to maintain these relationships could impair development[125](index=125&type=chunk)[126](index=126&type=chunk)[140](index=140&type=chunk) - The company faces **substantial competition** from large, established orthopedic and biotechnology companies with significantly greater resources, which may develop and commercialize products more successfully[179](index=179&type=chunk)[185](index=185&type=chunk)[187](index=187&type=chunk) - The company's ability to protect its **intellectual property** is critical, requiring compliance with its UCLA TDG license agreement and ensuring patents are sufficient to prevent competition[131](index=131&type=chunk)[140](index=140&type=chunk)[152](index=152&type=chunk) - To maintain its Nasdaq listing, the company must meet continued listing standards, including a minimum bid price of **$1.00**, with failure to do so potentially resulting in delisting[210](index=210&type=chunk) [Unresolved Staff Comments](index=52&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved comments from the SEC staff - None[232](index=232&type=chunk) [Cybersecurity](index=52&type=section&id=Item%201C.%20Cybersecurity) The company has implemented policies and processes to manage cybersecurity risks, with oversight from the Board of Directors - The **Board of Directors** oversees the company's cybersecurity risk management process[236](index=236&type=chunk) - The **CEO and CFO** are primarily responsible for assessing and managing material risks from cybersecurity threats[237](index=237&type=chunk) - The company has **not encountered any** cybersecurity challenges that are reasonably likely to materially impair its operations or financial standing[234](index=234&type=chunk) [Properties](index=53&type=section&id=Item%202.%20Properties) The company leases its principal executive office in Burlington, Massachusetts on a month-to-month basis - The company leases its primary office at 2 Burlington Woods Drive, Ste 100, Burlington, MA 01803, on a **month-to-month lease**[238](index=238&type=chunk) [Legal Proceedings](index=53&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings that would be expected to have a material adverse effect on its business or financial condition - The company is **not presently a party** to any legal proceedings that would have a material adverse effect on its business, results of operations, or financial condition[239](index=239&type=chunk) [Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[240](index=240&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=54&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 certain warrants are traded on The Nasdaq Capital Market, with 22 registered shareholders as of February 19, 2025 - The company's common stock and certain warrants trade on The **Nasdaq Capital Market** under the symbols "**BBLG**" and "**BBLGW**"[243](index=243&type=chunk) - As of **February 19, 2025**, there were **22 shareholders** of record[244](index=244&type=chunk) - The company has **never declared or paid cash dividends** and does not anticipate doing so in the foreseeable future[245](index=245&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=54&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's net loss decreased to $4.1 million in FY2024 from $8.9 million in FY2023, primarily due to reduced R&D expenses, but faces substantial doubt about its going concern ability [Results of Operations](index=56&type=section&id=Results%20of%20Operations) The company reported a net loss of $4.1 million in FY2024, a 54% improvement from FY2023, driven by a 69% decrease in Research and Development expenses Comparison of Operations for the Years Ended December 31 | | 2024 ($) | 2023 ($) | % Change | | :--- | :--- | :--- | :--- | | **Operating Expenses** | | | | | Research and development | $2,130,385 | $6,907,824 | (69.16)% | | General and administrative | $2,088,776 | $2,520,479 | (17.13)% | | **Total operating expenses** | **$4,219,161** | **$9,428,303** | **(55.25)%** | | **Loss from operations** | **($4,219,161)** | **($9,428,303)** | **(55.25)%** | | **Net loss** | **($4,112,420)** | **($8,948,731)** | **(54.04)%** | - Research and development expenses decreased by **$4.8 million** (**69.16%**) in 2024, primarily because significant expenses were incurred in 2023 to produce the NELL-1 protein needed for the initial clinical study[258](index=258&type=chunk) - General and administrative expenses decreased by **$431,703** (**17.13%**) in 2024, mainly due to higher legal expenses related to litigation matters in 2023[259](index=259&type=chunk)[260](index=260&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity challenges with an accumulated deficit of $85.0 million and cash expected to last only until Q4 2025, necessitating future capital raises - The company's financial condition raises substantial doubt about its ability to continue as a going concern, with an accumulated deficit of approximately **$85.0 million** and cash of **$3.3 million** as of December 31, 2024, expected to fund operations into **Q4 2025**[264](index=264&type=chunk)[276](index=276&type=chunk) - In **March 2024**, the company raised net proceeds of **$1.5 million** through a public offering of common stock and warrants[266](index=266&type=chunk) - In **August 2024**, the company raised net proceeds of **$1.8 million** through a warrant inducement transaction[270](index=270&type=chunk) - The company established an At-The-Market (ATM) offering facility in **September 2024**, raising net proceeds of **$1.1 million** during the year[273](index=273&type=chunk) Cash Flow Summary | Cash Flow Activity | Year Ended Dec 31, 2024 ($) | Year Ended Dec 31, 2023 ($) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($4,124,935) | ($9,555,904) | | Net Cash Provided by Financing Activities | $4,423,497 | $5,044,161 | [Quantitative and Qualitative Disclosures About Market Risk](index=60&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company - Not applicable[286](index=286&type=chunk) [Financial Statements and Supplementary Data](index=60&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section indicates that the company's financial statements and supplementary data are included in Part IV, Item 15 of the Annual Report - The required financial statements and supplementary data are included in **Item 15** of this Annual Report[287](index=287&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=60&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 on accounting and financial disclosure - None[288](index=288&type=chunk) [Controls and Procedures](index=60&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2024 - Management concluded that the company's disclosure controls and procedures were **effective** as of **December 31, 2024**[289](index=289&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of **December 31, 2024**, based on the criteria set forth by **COSO**[292](index=292&type=chunk) - **No changes** in internal control over financial reporting occurred during the fourth quarter of 2024 that materially affected, or are reasonably likely to materially affect, these controls[293](index=293&type=chunk) [Other Information](index=61&type=section&id=Item%209B.%20Other%20Information) During the fourth quarter of 2024, no director or officer of the company adopted or terminated a Rule 10b5-1 trading arrangement - **No director or officer** adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended December 31, 2024[295](index=295&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=61&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[296](index=296&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=62&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's executive team is led by CEO Jeffrey Frelick and CFO Deina Walsh, with a four-member independent Board of Directors overseeing governance - The company's executive officers are **Jeffrey Frelick** (CEO and President) and **Deina H. Walsh** (CFO)[299](index=299&type=chunk) - The Board of Directors has **four members**, all of whom have been determined to be **independent** under Nasdaq listing standards[308](index=308&type=chunk)[309](index=309&type=chunk) - The Board has **three standing committees**: Audit, Compensation, and Nominating and Corporate Governance, with all committee members being **independent**[313](index=313&type=chunk)[314](index=314&type=chunk)[315](index=315&type=chunk) - The company has adopted a **Code of Conduct and Ethics**, an **Insider Trading Policy**, and an **Anti-Hedging Policy**[317](index=317&type=chunk)[318](index=318&type=chunk)[319](index=319&type=chunk) [Executive Compensation](index=66&type=section&id=Item%2011.%20Executive%20Compensation) This section details the compensation for CEO Jeffrey Frelick and CFO Deina Walsh, including base salary, option awards, and non-equity incentive plan compensation FY2024 Summary Compensation Table | Name and Principal Position | Salary ($) | Option Awards ($) | Non-Equity Incentive Plan Compensation ($) | Total Compensation ($) | | :--- | :--- | :--- | :--- | :--- | | Jeffrey Frelick, CEO and President | $300,000 | $30,788 | $54,109 | $384,897 | | Deina Walsh, CFO | $200,000 | $15,394 | $27,054 | $242,448 | - CEO Jeffrey Frelick's employment agreement includes a **$300,000** annual salary and a target bonus of **50%** of base salary[324](index=324&type=chunk) - CFO Deina Walsh's employment agreement includes a **$200,000** annual salary and a target bonus of **25%** of base salary[326](index=326&type=chunk)[327](index=327&type=chunk) - Non-employee directors receive annual cash retainers (**$25,000** for members, **$35,000** for the Chair) and automatic equity grants (initial and annual stock options)[341](index=341&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=72&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section discloses equity compensation plan information and beneficial ownership, with directors and executive officers owning 6.1% of outstanding common stock Equity Compensation Plan Information (as of December 31, 2024) | Plan Category | Securities to be Issued Upon Exercise | Weighted-Average Exercise Price ($) | Securities Remaining Available for Future Issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 194,484 | $42.14 | 435,005 | - As of February 19, 2025, all directors and executive officers as a group (6 persons) beneficially owned **213,266** shares, representing **6.1%** of the outstanding common stock[355](index=355&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=74&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company reports no material related person transactions since January 1, 2023, and all four directors are deemed independent under Nasdaq rules - Since January 1, 2023, there have been **no transactions** with related persons that had a direct or indirect material interest[357](index=357&type=chunk) - The Board of Directors has determined that **all four** of its members (Bruce Stroever, Sid Angle, Robert Gagnon, and Phil Meikle) qualify as **independent** under Nasdaq Listing Rules[358](index=358&type=chunk) [Principal Accountant Fees and Services](index=75&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) This section details the fees billed by Weinberg & Company, P.A., totaling $178,728 in 2024, with all services pre-approved by the Audit Committee Accountant Fees Billed by Weinberg & Company, P.A. | Fee Category | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Audit Fees | $89,108 | $121,437 | | Audit Related Fees | $89,620 | $19,310 | | Tax fees | $0 | $0 | | All other fees | $0 | $0 | | **Total** | **$178,728** | **$140,747** | - The **Audit Committee pre-approves** all audit and permissible non-audit services provided by the independent registered public accounting firm[360](index=360&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=76&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Form 10-K, including consolidated financial statements and various exhibits - This section contains the list of **financial statements and exhibits** filed with the annual report[368](index=368&type=chunk)[369](index=369&type=chunk) [Form 10-K Summary](index=81&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is noted as "None," indicating no summary is provided - None[376](index=376&type=chunk)[377](index=377&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=85&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor issued a qualified opinion with a going concern emphasis due to recurring losses and identified the 2024 warrant inducement as a critical audit matter - The auditor's report expresses substantial doubt about the Company's ability to continue as a going concern, citing a net loss of **$4.1 million** and cash used in operations of **$4.1 million** in 2024[390](index=390&type=chunk) - A **critical audit matter** was identified related to the accounting for the **August 2024** warrant inducement, due to the significant management judgments required for its valuation and presentation[395](index=395&type=chunk)[396](index=396&type=chunk) [Consolidated Financial Statements](index=87&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show $3.3 million in cash and a $4.1 million net loss in 2024, reflecting significant financing activities and ongoing going concern risk [Consolidated Balance Sheets](index=87&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2024, the company reported total assets of $3.9 million, primarily cash, with total stockholders' equity increasing to $3.5 million Consolidated Balance Sheet Data (as of December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash | $3,325,131 | $3,026,569 | | Total Current Assets | $3,861,369 | $3,737,763 | | **Total Assets** | **$3,861,369** | **$3,737,763** | | **Liabilities & Equity** | | | | Total Current Liabilities | $377,712 | $831,402 | | **Total Liabilities** | **$377,712** | **$831,402** | | **Total Stockholders' Equity** | **$3,483,657** | **$2,906,361** | [Consolidated Statements of Operations](index=88&type=section&id=Consolidated%20Statements%20of%20Operations) For FY2024, the company reported no revenue and a net loss of $4.1 million, a significant improvement from the $8.9 million loss in 2023 due to lower R&D expenses Consolidated Statement of Operations Data (For the Year Ended December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Total operating expenses | $4,219,161 | $9,428,303 | | Loss from operations | ($4,219,161) | ($9,428,303) | | **Net loss** | **($4,112,420)** | **($8,948,731)** | | **Net loss attributable to common stockholders** | **($7,324,924)** | **($8,948,731)** | | **Loss per share – basic and diluted** | **($4.83)** | **($34.01)** | [Consolidated Statements of Cash Flows](index=90&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2024, the company used $4.1 million in operating cash, offset by $4.4 million from financing, resulting in a net cash increase of $0.3 million and a year-end balance of $3.3 million Consolidated Statement of Cash Flows Data (For the Year Ended December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,124,935) | ($9,555,904) | | Net cash provided by financing activities | $4,423,497 | $5,044,161 | | Net increase (decrease) in cash | $298,562 | ($4,511,743) | | **Cash, end of year** | **$3,325,131** | **$3,026,569** | [Notes to Consolidated Financial Statements](index=91&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes highlight the company's going concern risk, details of R&D expenses, significant 2024 financing activities including a $3.2 million non-cash deemed dividend, and commitments to UCLA - Note 1 (Going Concern): The company has an accumulated deficit of ~**$85.0 million** and expects its current cash of **$3.3 million** to fund operations only up to **Q4 2025**, raising substantial doubt about its ability to continue as a going concern[416](index=416&type=chunk)[418](index=418&type=chunk) - Note 3 (R&D): Research and development costs totaled **$2.1 million** in 2024 and **$6.9 million** in 2023, primarily related to the pilot clinical study for the NB1 bone graft device being conducted in Australia[456](index=456&type=chunk)[457](index=457&type=chunk) - Note 6 (Stockholders' Equity): In **August 2024**, a warrant inducement transaction resulted in the exercise of existing warrants for **$1.9 million** in gross proceeds and was accounted for with a **$3.2 million** non-cash deemed dividend[473](index=473&type=chunk) - Note 10 (Commitments): Under the UCLA TDG license agreement, the company was triggered to pay a **$100,000** milestone fee in **2024** upon treatment of the first patients in its pilot clinical study, with future milestone, royalty, and diligence fee payments contingent on development and sales progress[496](index=496&type=chunk)[499](index=499&type=chunk)

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements.) The unaudited condensed consolidated financial statements for the nine months ended September 30, 2024, show a $2.6 million net loss and increased cash from financing activities [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2024, total assets were $4.1 million, liabilities reduced to $0.27 million, and stockholders' equity increased to $3.8 million from financing activities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Items | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $3,566,426 | $3,026,569 | | Total current assets | $4,065,818 | $3,737,763 | | **Total assets** | **$4,065,818** | **$3,737,763** | | **Liabilities & Equity** | | | | Total current liabilities | $273,402 | $831,402 | | Total liabilities | $273,402 | $831,402 | | Total stockholders' equity | $3,792,416 | $2,906,361 | | **Total liabilities and stockholders' equity** | **$4,065,818** | **$3,737,763** | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For the nine months ended September 30, 2024, the company reported no revenue and a net loss of $2.6 million, a significant improvement driven by reduced R&D expenses Condensed Consolidated Statements of Operations (Unaudited) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Research and development | $1,025,814 | $6,460,747 | | General and administrative | $1,638,409 | $1,807,548 | | Loss from operations | $(2,664,223) | $(8,268,295) | | Net loss | $(2,590,705) | $(7,398,846) | | Net loss attributable to common stockholders | $(5,803,209) | $(7,398,846) | | Loss per share – basic and diluted | $(4.85) | $(37.40) | [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity increased from $2.9 million to $3.8 million as of September 30, 2024, driven by stock and warrant sales, partially offset by a $3.2 million non-cash deemed dividend - Total stockholders' equity increased from **$2.91 million** at December 31, 2023, to **$3.79 million** at September 30, 2024[15](index=15&type=chunk) - Key activities impacting equity in the first nine months of 2024 include a public offering raising net proceeds of **$1.5 million**, a warrant inducement raising net proceeds of **$1.8 million**, and a non-cash deemed dividend of **$3.2 million**[15](index=15&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2024, net cash used in operations decreased to **$2.8 million**, with financing providing **$3.3 million**, resulting in a **$0.54 million** net cash increase and a **$3.6 million** ending balance Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,771,438) | $(7,537,889) | | Net cash provided by financing activities | $3,311,295 | $4,452,163 | | Net increase (decrease) in cash | $539,857 | $(3,085,726) | | **Cash, end of period** | **$3,566,426** | **$4,452,586** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, accounting policies, and financial activities, highlighting its 'going concern' status due to an **$83.5 million** accumulated deficit, recent financing efforts, and a **$100,000** milestone payment - The company has an accumulated deficit of approximately **$83.5 million** and expects significant development expenses, raising substantial doubt about its ability to continue as a going concern[24](index=24&type=chunk) - As of September 30, 2024, the company had **$3.6 million** in cash, anticipated to cover operational needs into the second quarter of 2025[26](index=26&type=chunk) - In August 2024, the company executed a warrant inducement, raising net proceeds of **$1.81 million** and recording a non-cash deemed dividend of **$3.21 million**[59](index=59&type=chunk) - During the nine months ended September 30, 2024, the company triggered a **$100,000** milestone payment to UCLA TDG for enrolling the first patient in its pilot clinical study[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial results, highlighting the company's development stage, significant R&D expense reduction, and critical need for future financing due to limited liquidity [Company Overview](index=21&type=section&id=Company%20Overview) The company is a development-stage medical device firm focused on bone regeneration in spinal fusion using NELL-1 technology, having treated its first patient in a pilot clinical study in Australia on June 20, 2024 - The company is a medical device company focused on bone regeneration in spinal fusion using the recombinant human protein NELL-1, licensed exclusively from UCLA TDG[91](index=91&type=chunk) - On June 20, 2024, the first patient was treated in the multicenter, prospective, randomized pilot clinical study of the Company's NB1 bone graft device in Australia[95](index=95&type=chunk)[96](index=96&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) The analysis compares operating results, highlighting a significant decrease in R&D expenses by **84.1%** for the nine-month period ended September 30, 2024, due to NELL-1 protein production completion, leading to a reduced net loss Comparison of Operating Results (Nine Months Ended) | Operating Expenses | September 30, 2024 | September 30, 2023 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $1,025,814 | $6,460,747 | (84.12)% | | General and administrative | $1,638,409 | $1,807,548 | (9.36)% | | **Total operating expenses** | **$2,664,223** | **$8,268,295** | **(67.78)%** | | **Net loss** | **$(2,590,705)** | **$(7,398,846)** | **(64.99)%** | - The decrease in R&D costs is attributed to significant expenses incurred in 2023 for the production of the NELL-1 protein necessary for the initial clinical study[113](index=113&type=chunk)[117](index=117&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about its going concern status due to an **$83.5 million** accumulated deficit, with **$3.6 million** cash expected to fund operations only into Q2 2025, necessitating continued capital raises - The company has an accumulated deficit of approximately **$83.5 million** and estimates operating expenditures for the next twelve months at **$5.4 million**, raising substantial doubt about its ability to continue as a going concern[120](index=120&type=chunk) - Available cash of **$3.57 million** as of September 30, 2024, is anticipated to cover operational needs into the second quarter of 2025[129](index=129&type=chunk) - The company anticipates requiring approximately **$5 million** to complete first-in-man studies and an additional **$24 million** in scientific expenses to achieve FDA approval for a spine interbody fusion indication[129](index=129&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states this item is not applicable, indicating no significant exposure to market risks like interest rate or foreign currency exchange risk - Not applicable[132](index=132&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2024, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of September 30, 2024, the company's disclosure controls and procedures were effective[132](index=132&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended September 30, 2024[133](index=133&type=chunk) [PART II – OTHER INFORMATION](index=29&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports no material updates to legal proceedings previously disclosed in its Annual Report on Form 10-K and prior Quarterly Reports - There are no material updates to the matters previously disclosed in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023[133](index=133&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors.) The company states there have been no material changes from the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2023 - There have been no material changes from the risk factors as previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2023[134](index=134&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reports no issuance of unregistered equity securities during the third quarter of 2024 that were not previously reported - During the third quarter of 2024, the company did not issue any shares in reliance on Section 4(a)(2) of the Securities Act which have not previously been reported[135](index=135&type=chunk) [Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reports no defaults upon senior securities - None[135](index=135&type=chunk) [Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not Applicable[135](index=135&type=chunk) [Other Information](index=30&type=section&id=Item%205.%20Other%20Information.) The company discloses that no director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the third quarter of 2024 - During the three months ended September 30, 2024, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement[136](index=136&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the report, including warrant agreements, an 'at the market' offering agreement, and various officer certifications - Exhibits filed include agreements related to the August 2024 warrant inducement, the September 2024 At The Market Offering Agreement, and required CEO/CFO certifications[138](index=138&type=chunk)

PART I – FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements.) Bone Biologics, a development-stage medical device company, reported no revenue, a reduced net loss, and a going concern warning [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet highlights key financial positions including cash, total current assets, liabilities, and accumulated deficit Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $2,332,068 | $3,026,569 | | Total current assets | $3,193,464 | $3,737,763 | | **Liabilities & Equity** | | | | Total current liabilities | $284,507 | $831,402 | | Total stockholders' equity | $2,908,957 | $2,906,361 | | Accumulated deficit | $(82,558,661) | $(80,908,958) | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations details revenues, R&D, G&A expenses, leading to loss from operations and net loss Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $0 | $0 | $0 | | Research and development | $350,442 | $2,295,251 | $596,067 | $4,885,896 | | General and administrative | $459,223 | $744,617 | $1,117,135 | $1,301,509 | | **Loss from operations** | **$(809,665)** | **$(3,039,868)** | **$(1,713,202)** | **$(6,187,405)** | | **Net Loss** | **$(783,733)** | **$(1,769,238)** | **$(1,649,703)** | **$(5,479,137)** | | **Loss per share** | **$(0.67)** | **$(5.21)** | **$(1.80)** | **$(18.57)** | [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This statement outlines changes in stockholders' equity, including impacts from net loss, public offerings, and warrant exercises - For the six months ended June 30, 2024, total stockholders' equity slightly increased from **$2,906,361** to **$2,908,957**. This was driven by proceeds from a public offering and warrant exercises, which were largely offset by the net loss for the period[16](index=16&type=chunk) - In March 2024, the company raised approximately **$1.5 million** (net of offering costs) from the sale of common stock and pre-funded warrants[16](index=16&type=chunk)[56](index=56&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statement summarizes cash used in operating activities, provided by financing, and net decrease in cash Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,199,276) | $(4,982,666) | | Net cash provided by financing activities | $1,504,775 | $4,452,163 | | **Net decrease in cash** | **$(694,501)** | **$(530,503)** | | **Cash, end of period** | **$2,332,068** | **$7,007,809** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes include details on reverse stock splits, warrant liabilities, license obligations, and subsequent events - The company executed two reverse stock splits: a **1-for-30** split on June 5, 2023, and a **1-for-8** split on December 20, 2023. All share and per-share amounts have been retroactively restated[30](index=30&type=chunk) - The company has a warrant liability of **$7,655** as of June 30, 2024, which is classified as a liability and re-measured at fair value each reporting period due to certain provisions in the warrants issued in October 2022[42](index=42&type=chunk)[51](index=51&type=chunk) - Under the license agreement with UCLA TDG, the company is obligated to make milestone payments, including **$100,000** upon enrollment of the first subject in a Feasibility Study, which was triggered during the six months ended June 30, 2024[75](index=75&type=chunk)[77](index=77&type=chunk) - Subsequent to the quarter end, on August 2, 2024, the company completed a warrant inducement transaction, generating net proceeds of approximately **$1.7 million**[28](index=28&type=chunk)[80](index=80&type=chunk) - The company is a medical device firm focused on bone regeneration using the NELL-1 protein, licensed exclusively from UCLA TDG. Its product is classified as a device/drug combination product requiring FDA pre-market approval[23](index=23&type=chunk) - The company has incurred an accumulated deficit of approximately **$82.6 million** since inception and has not generated any revenue. These factors, along with a net loss of **$1.6 million** and **$2.2 million** cash used in operations in the first six months of 2024, raise substantial doubt about its ability to continue as a going concern[26](index=26&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes reduced net loss to lower R&D costs; cash expected to fund operations only into Q1 2025 - On June 20, 2024, the company announced the treatment of the first patient in its multicenter, prospective, randomized pilot clinical study of the NB1 bone graft device in Australia. The study will evaluate safety and effectiveness in **30 subjects** undergoing transforaminal lumbar interbody fusion (TLIF)[88](index=88&type=chunk)[89](index=89&type=chunk) Comparison of Operating Expenses (Three Months Ended June 30) | Expense Category | 2024 | 2023 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $350,442 | $2,295,251 | (84.73)% | | General and administrative | $459,223 | $744,617 | (38.33)% | | **Total operating expenses** | **$809,665** | **$3,039,868** | **(73.37)%** | Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2024 | 2023 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $596,067 | $4,885,896 | (87.80)% | | General and administrative | $1,117,135 | $1,301,509 | (14.17)% | | **Total operating expenses** | **$1,713,202** | **$6,187,405** | **(72.31)%** | - The significant decrease in R&D expenses in 2024 is attributed to the high costs incurred in 2023 for the production of the NELL-1 protein required for the initial clinical study[102](index=102&type=chunk)[107](index=107&type=chunk) - The company's cash of **$2.3 million** at June 30, 2024, supplemented by the **$1.7 million** from the August 2024 warrant inducement, is anticipated to cover operational needs only into the first quarter of 2025[116](index=116&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company has indicated that this item is not applicable - Not applicable[119](index=119&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective with no material changes to internal control - Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2024[119](index=119&type=chunk) - No changes occurred in the internal control over financial reporting during the quarter ended June 30, 2024, that have materially affected, or are reasonably likely to materially affect, these controls[120](index=120&type=chunk) PART II – OTHER INFORMATION This section provides updates on legal proceedings, risk factors, equity sales, other information, and exhibits [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) No material updates to legal proceedings previously disclosed in the company's Annual Report on Form 10-K or Q1 2024 Form 10-Q - There are no material updates to previously disclosed legal matters[121](index=121&type=chunk) [Risk Factors](index=29&type=page&id=Item%201A.%20Risk%20Factors) No material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K - Investors are referred to the risk factors section of the company's Annual Report on Form 10-K for the year ended December 31, 2023, as there have been no material changes[122](index=122&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[122](index=122&type=chunk) [Other Information](index=29&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the second quarter of 2024 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended June 30, 2024[123](index=123&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer List of Exhibits | Exhibit Number | Description | | :--- | :--- | | 31.1 | CEO Certification (Section 302) | | 31.2 | CFO Certification (Section 302) | | 32.1 | CEO Certification (Section 906) | | 32.2 | CFO Certification (Section 906) | | 101.INS - 101.PRE | Inline XBRL Documents |