Appointment strengthens Board expertise as Milestone Scientific drives commercial expansion and payer adoption of CompuFlo® in interventional pain managementROSELAND, N.J., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced the appointment of Dawood Sayed, M.D., a nationally recognized leader in interventional pain medicine, to its Board of Directors, effective ...

Financial Data and Key Metrics Changes - Consolidated revenue for Q2 2025 was approximately $2.3 million, an increase of 25% compared to the same period in 2024, driven primarily by the dental segment [11][14] - Consolidated gross profit for Q2 2025 was approximately $1.6 million, an increase of approximately $206,000 compared to approximately $1.4 million for the same period in 2024 [14] - The loss from operations decreased to approximately $1.5 million in Q2 2025 from $1.8 million in Q2 2024, a decrease of approximately $296,000 [16] Business Line Data and Key Metrics Changes - Dental revenue for Q2 2025 was approximately $1.3 million, with international sales more than doubling [14] - Medical revenue increased to approximately $32,000 in Q2 2025 from $19,000 in Q2 2024, reflecting a growth of $13,000 [14] - For the six months ending June 30, 2025, medical revenue was approximately $83,000, an increase of $57,000 compared to the same period in 2024 [17] Market Data and Key Metrics Changes - International revenue for Q2 2025 was approximately $1.49 million, an increase of $511,000 compared to the same period in 2024 [14] - International sales accounted for 48% of total revenues in Q2 2025, driven by additional distributors and larger orders [32] Company Strategy and Development Direction - The company is focusing on accelerating penetration in existing markets, expanding internationally, and capturing greater share in the U.S. dental market through targeted marketing and direct engagement [12] - In the medical segment, the strategy includes building on the reimbursement foundation and pursuing new distribution partnerships both domestically and internationally [12] - The leadership team emphasizes disciplined execution and focused growth in both medical and dental sectors [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the untapped potential of the company, highlighting the importance of disciplined execution and data collection for reimbursement processes [9][25] - The recent addition of key leadership members is expected to drive growth and improve operational efficiency [5][8] - Management acknowledged the challenges in the medical segment but is committed to focusing efforts on a few clinics to gather data and improve adoption rates [25][26] Other Important Information - The company has maintained a solid balance sheet with cash and cash equivalents of $1.3 million and working capital of approximately $3.9 million, with no long-term debt [18] - The company is actively managing expenses and evaluating where to allocate resources for future growth [76] Q&A Session Summary Question: Can you discuss the medical side and adoption of the CompuFlo system? - Management indicated that between five and ten clinics are currently using the product in the U.S. market and emphasized a focused approach to data collection and reimbursement [25][26] Question: Have there been other key hires besides Jason Papes? - Management confirmed that Jason brings a team with him and is evaluating additional hires based on current talent in the marketplace [28][29] Question: What percentage of revenues came from international sales this quarter? - International sales accounted for 48% of total revenues, with growth driven by additional distributors and larger orders [32] Question: What role do tariffs play in international sales? - Management stated that tariffs have been mitigated by shipping directly from their warehouse in China, ensuring that inventory levels remain unaffected [40][42] Question: What is the status of reimbursement with JMAC and private payers? - Management plans to focus on existing users of the CompuFlo system to understand reimbursement processes before expanding to new markets [43][46] Question: How bullish are clinicians on the technology? - Management acknowledged the need for focused efforts to gather insights from clinicians and emphasized the importance of understanding use cases before broader market expansion [55][56] Question: What is the status of the VA opportunities? - Management is actively engaged with VA facilities and plans to focus on one vision to create a successful model before expanding further [66][68] Question: What is the situation with Brazil? - Management indicated that Brazil remains a long-term potential market but is not a focus in the near term due to recent tariffs [70]

Core Insights - Milestone Scientific Inc. reported a 25% increase in revenue for Q2 2025, reaching $2.3 million, primarily driven by strong international dental sales which more than doubled year-over-year [2][3] - The company has strengthened its leadership team, appointing Eric Hines as the new CEO and Jason Papes as Senior Vice President, Global Head of Sales and Marketing, to support its growth strategy [2] - The gross margin for Q2 2025 was maintained at 70%, reflecting the high-margin dental business and effective cost management [2] Financial Performance - For Q2 2025, revenues were approximately $2.3 million, up from $1.9 million in Q2 2024, marking an increase of about $470,000 [3] - International revenue for Q2 2025 was approximately $1.0 million, an increase of approximately $524,000 compared to the same period in 2024 [3] - The net loss for Q2 2025 was approximately $(1.5) million, or $(0.02) per share, compared to a net profit of $0.2 million, or $0.00 per share, in Q2 2024 [3] Business Strategy - The company aims to accelerate growth in both dental and medical segments by enhancing its direct sales model, e-commerce platform, and targeted marketing campaigns [2] - In the medical segment, Milestone Scientific is focusing on advancing the adoption of its CompuFlo® Epidural System, having secured Medicare Part B payment rate assignment and initial coverage from commercial insurers [2] - Future plans include broadening federal presence, expanding internationally with new distribution partners, and unlocking potential in both business segments [2] Leadership Changes - Eric Hines, the new CEO, is expected to guide the company through its next growth phase, leveraging his experience in operational excellence [2] - Jason Papes brings a proven track record in global sales strategies, enhancing the company's capabilities in sales and marketing [2] - Shanth Thiyagalingam has joined the Board of Directors, contributing over 20 years of medtech executive experience [2] Cash Position - As of June 30, 2025, the company reported cash and cash equivalents of approximately $1.3 million and working capital of approximately $3.9 million [6]

[Cover Page](index=1&type=section&id=Cover%20Page) This section provides key administrative details of the Form 10-Q filing for Milestone Scientific Inc. for the quarter ended June 30, 2025 - The filing is a Form 10-Q for Milestone Scientific Inc. for the quarter ended June 30, 2025[1](index=1&type=chunk) - Milestone Scientific Inc. is classified as a **non-accelerated filer** and a **smaller reporting company**[3](index=3&type=chunk) - As of August 14, 2025, there were **78,559,147 shares of Common Stock outstanding**[5](index=5&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines the inherent risks and uncertainties associated with forward-looking statements, which may cause actual results to differ materially from projections - The report contains forward-looking statements subject to numerous risks and uncertainties, which may cause actual results to differ materially from expectations[10](index=10&type=chunk) - Key risks include continued operating losses, the need for additional funding, early stage of medical products, reliance on third-party manufacturers, and competitive developments[10](index=10&type=chunk) [PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section includes the unaudited condensed consolidated financial statements, comprising the Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity, Statements of Cash Flows, and accompanying notes, providing a detailed financial overview for the periods presented [Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024](index=5&type=section&id=Balance%20Sheets%20as%20of%20June%2030%2C%202025%20(Unaudited)%20and%20December%2031%2C%202024) This section presents the company's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $1,274,314 | $3,258,058 | | Total current assets | $7,630,828 | $9,286,554 | | Total assets | $8,050,830 | $9,797,072 | | Total current liabilities | $3,767,670 | $3,744,127 | | Convertible notes payable, related parties | $800,000 | $- | | Total liabilities | $4,710,558 | $3,964,372 | | Total stockholders' equity | $3,340,272 | $5,832,700 | - Total assets decreased by **$1.7 million** from December 31, 2024, to June 30, 2025, primarily due to a reduction in cash and cash equivalents[13](index=13&type=chunk) - Total liabilities increased by **$0.7 million**, driven by the issuance of **$0.8 million** in convertible notes payable to related parties[13](index=13&type=chunk) [Statements of Operations for the three and six months ended June 30, 2025 and 2024 (Unaudited)](index=6&type=section&id=Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section details the company's financial performance, including product sales, gross profit, and net loss for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | | :-------------------------- | :----------- | :----------- | :----------- | | Product sales, net | $2,323,466 | $1,853,764 | $469,702 | | Gross profit | $1,617,606 | $1,411,204 | $206,402 | | Loss from operations | $(1,484,631) | $(1,780,423) | $295,792 | | Gain on sale of net operating losses | $- | $1,983,095 | $(1,983,095) | | Net loss | $(1,483,110) | $223,638 | $(1,706,748) | | Basic and Diluted EPS | $(0.02) | $0.00 | $(0.02) | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Metric | 2025 | 2024 | Change | | :-------------------------- | :----------- | :----------- | :----------- | | Product sales, net | $4,555,886 | $4,102,609 | $453,277 | | Gross profit | $3,265,041 | $3,087,307 | $177,734 | | Loss from operations | $(3,482,484) | $(3,245,491) | $(236,993) | | Gain on sale of net operating losses | $- | $1,983,095 | $(1,983,095) | | Net loss | $(3,477,696) | $(1,216,891) | $(2,260,805) | | Basic and Diluted EPS | $(0.04) | $(0.02) | $(0.02) | - The significant increase in net loss for both periods in 2025 is primarily due to the absence of the **$2.0 million gain on sale of net operating losses** recognized in 2024[14](index=14&type=chunk)[106](index=106&type=chunk) [Statements of Changes in Stockholders' Equity for the three and six months ended June 30, 2025 and 2024 (Unaudited)](index=7&type=section&id=Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section outlines the changes in stockholders' equity, reflecting net losses, stock-based compensation, and common stock issuances for the periods presented - Total stockholder equity decreased from **$5.8 million** at January 1, 2025, to **$3.3 million** at June 30, 2025[16](index=16&type=chunk) - The decrease in equity is primarily attributable to net losses of **$(2.0 million)** for the three months ended March 31, 2025, and **$(1.5 million)** for the three months ended June 30, 2025[16](index=16&type=chunk) - Changes also reflect stock-based compensation expenses and common stock issued for consulting services[16](index=16&type=chunk) [Statements of Cash Flows for the six months ended June 30, 2025 and 2024 (Unaudited)](index=9&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section presents the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Cash Flow Category | 2025 | 2024 | Change | | :----------------------------------- | :------------- | :------------- | :------------- | | Net cash used in operating activities | $(2,772,273) | $(434,473) | $(2,337,800) | | Net cash (used in) provided by investing activities | $(5,776) | $2,969,977 | $(2,975,753) | | Net cash provided by financing activities | $794,305 | $238,889 | $555,416 | | Net (decrease) increase in cash | $(1,983,744) | $2,774,393 | $(4,758,137) | - Cash used in operating activities increased significantly by **$2.3 million**, primarily due to a larger net loss in 2025[119](index=119&type=chunk) - Investing activities shifted from providing **$3.0 million** in 2024 (due to marketable securities sale) to using **$5,776** in 2025[120](index=120&type=chunk) [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section provides detailed explanatory notes to the condensed consolidated financial statements, offering additional context and disclosures for various accounts and transactions [NOTE 1 — ORGANIZATION AND BUSINESS](index=10&type=section&id=NOTE%201%20%E2%80%94%20ORGANIZATION%20AND%20BUSINESS) This note describes Milestone Scientific Inc.'s core business as a biomedical technology company focused on computer-controlled anesthetic delivery devices for dental and medical markets - Milestone Scientific Inc. is a biomedical technology company focused on proprietary, computer-controlled anesthetic delivery devices for dental and medical markets[21](index=21&type=chunk)[92](index=92&type=chunk) - Key trademarks include **CompuDent®**, **STA Single Tooth Anesthesia System®** (dental), and **CompuFlo® Epidural Computer Controlled Anesthesia System** (medical)[20](index=20&type=chunk)[21](index=21&type=chunk)[95](index=95&type=chunk) - The company holds over **317 U.S. and foreign patents** related to drug delivery methodologies[96](index=96&type=chunk) [NOTE 2 — GOING CONCERN AND LIQUIDITY](index=10&type=section&id=NOTE%202%20%E2%80%94%20GOING%20CONCERN%20AND%20LIQUIDITY) This note addresses the company's going concern status due to recurring losses and the need for additional capital, outlining management's plans to secure funding - Substantial doubt exists about the company's ability to continue as a going concern due to recurring losses, an accumulated deficit of **$131.5 million**, and the need for additional capital[23](index=23&type=chunk)[24](index=24&type=chunk)[124](index=124&type=chunk) - As of June 30, 2025, cash and cash equivalents were approximately **$1.3 million**, and working capital was approximately **$3.9 million**[23](index=23&type=chunk)[123](index=123&type=chunk) - Management plans to seek additional funding through equity or debt financings and aims to generate positive cash flows by increasing revenue and reducing operating expenses[25](index=25&type=chunk)[26](index=26&type=chunk)[126](index=126&type=chunk) [NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=11&type=section&id=NOTE%203%20%E2%80%94%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note details the significant accounting policies used in preparing the condensed consolidated financial statements, including revenue recognition and segment reporting - The unaudited condensed consolidated financial statements are prepared in accordance with GAAP for interim financial information[28](index=28&type=chunk) - Revenue from product sales is recognized at the point of shipment, with no post-sale installation or maintenance obligations[31](index=31&type=chunk) - The company disaggregates revenue by its two operating segments (Dental and Medical) and by geographical market[36](index=36&type=chunk)[37](index=37&type=chunk) [NOTE 4 — INVENTORIES](index=14&type=section&id=NOTE%204%20%E2%80%94%20INVENTORIES) This note provides a breakdown of inventory composition, including finished goods and component parts, and details the allowance for slow-moving medical finished goods Inventories Composition | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :----------- | :---------------- | | Dental finished goods | $3,677,357 | $3,640,391 | | Medical finished goods | $121,815 | $- | | Component parts and other materials | $97,845 | $72,824 | | **Total inventories** | **$3,897,017** | **$3,713,215** | - The company maintains an allowance of approximately **$1.1 million** for slow-moving Medical finished goods due to the slow adoption of epidural instruments and handpieces[48](index=48&type=chunk) [NOTE 5 — ADVANCES ON CONTRACTS](index=14&type=section&id=NOTE%205%20%E2%80%94%20ADVANCES%20ON%20CONTRACTS) This note outlines the company's advances on contracts, representing funding received for future deliveries of STA devices, epidural instruments, and replacement parts Advances on Contracts | Date | Amount | | :---------------- | :----------- | | June 30, 2025 | $1,131,284 | | December 31, 2024 | $1,275,260 | - Advances on contracts represent funding for future STA devices, epidural instruments, and epidural replacement parts[49](index=49&type=chunk) [NOTE 6 — CONVERTIBLE NOTE PAYABLE, RELATED PARTY](index=14&type=section&id=NOTE%206%20%E2%80%94%20CONVERTIBLE%20NOTE%20PAYABLE%2C%20RELATED%20PARTY) This note details the issuance of convertible promissory notes to related parties, including terms, interest rates, and conversion features into common stock - On April 9, 2025, the Company issued **$0.8 million** in promissory notes to directors, due April 9, 2028, with interest at prime less 2.50%[50](index=50&type=chunk) - The notes are convertible into common stock by the holder at any time and by the Company at maturity, with a conversion rate based on the fair value of common stock (not less than **$0.50**)[51](index=51&type=chunk) - As of June 30, 2025, these notes were convertible into **963,855 shares of common stock**[51](index=51&type=chunk) [NOTE 7 — STOCKHOLDERS' EQUITY](index=15&type=section&id=NOTE%207%20%E2%80%94%20STOCKHOLDERS'%20EQUITY) This note describes changes in stockholders' equity, including public offerings, shares to be issued for services, and the impact of net losses on total equity - In January 2024, a public offering resulted in net proceeds of **$192,156** from the exercise of an over-allotment option for **372,110 shares**[52](index=52&type=chunk) Shares-to-be-issued Outstanding | Date | Shares Outstanding | | :---------------- | :----------------- | | June 30, 2025 | 3,708,663 | | June 30, 2024 | 3,184,683 | - These shares are to be issued to employees, officers, directors, and non-employees for services rendered, with issuance deferred under various agreements[53](index=53&type=chunk)[54](index=54&type=chunk) [NOTE 8 — STOCK OPTION PLANS](index=15&type=section&id=NOTE%208%20%E2%80%94%20STOCK%20OPTION%20PLANS) This note details employee stock-based compensation expense, unrecognized compensation costs, and the vesting status of restricted stock awards - Total employee stock-based compensation expense was approximately **$0.3 million** for the six months ended June 30, 2025[58](index=58&type=chunk) - As of June 30, 2025, there was **$0.5 million** of unrecognized compensation cost related to non-vested options, expected to be recognized over a weighted average period of **0.75 years**[59](index=59&type=chunk) - Restricted stock awards granted in June 2024 were fully vested by April 2025, resulting in no unrecognized compensation expense as of June 30, 2025[61](index=61&type=chunk) [NOTE 9 — INCOME TAXES](index=16&type=section&id=NOTE%209%20%E2%80%94%20INCOME%20TAXES) This note discusses the company's income tax position, including valuation allowances for deferred tax assets and the gain from the sale of net operating losses - Milestone Scientific has a **100% valuation allowance** for all its deferred tax assets due to uncertainty regarding their future realization[62](index=62&type=chunk) - In April 2024, the company received approximately **$2.0 million** from the sale of New Jersey net operating losses (NOLs), recorded as a gain[63](index=63&type=chunk) - The company is required to maintain a physical presence in New Jersey for **5 years** after the NOL sale or face a potential liability of up to **$2.2 million**[64](index=64&type=chunk) [NOTE 10 — SEGMENT AND GEOGRAPHIC DATA](index=17&type=section&id=NOTE%2010%20%E2%80%94%20SEGMENT%20AND%20GEOGRAPHIC%20DATA) This note provides financial data disaggregated by the company's Dental and Medical operating segments, including product sales, gross margin, and operating income or loss - The company operates in two reportable segments: Dental and Medical, with financial performance assessed by the CEO based on product sales and operating income/loss[64](index=64&type=chunk) Segment Performance (Six Months Ended June 30, 2025) | Metric | Dental | Medical | Corporate | Grand Total | | :-------------------------- | :----------- | :----------- | :----------- | :----------- | | Product sales, net | $4,472,536 | $83,350 | $- | $4,555,886 | | Gross Margin | $3,182,775 | $82,266 | $- | $3,265,041 | | Operating income (loss) | $634,979 | $(844,402) | $(3,273,061) | $(3,482,484) | Segment Performance (Six Months Ended June 30, 2024) | Metric | Dental | Medical | Corporate | Grand Total | | :-------------------------- | :----------- | :----------- | :----------- | :----------- | | Product sales, net | $4,076,189 | $26,420 | $- | $4,102,609 | | Gross Margin | $3,065,234 | $22,073 | $- | $3,087,307 | | Operating income (loss) | $845,601 | $(1,014,700) | $(3,076,392) | $(3,245,491) | [NOTE 11 — CONCENTRATIONS](index=19&type=section&id=NOTE%2011%20%E2%80%94%20CONCENTRATIONS) This note highlights the company's reliance on third-party manufacturers and key distributors, along with the contribution of e-commerce sales to net product sales - The company relies on informal arrangements with third-party U.S. manufacturers for its STA devices and epidural instruments; termination of these relationships could have a material adverse effect[69](index=69&type=chunk) E-Commerce Sales Contribution to Net Product Sales | Period | % of Net Product Sales | | :-------------------------- | :--------------------- | | Three months ended June 30, 2025 | 53% | | Three months ended June 30, 2024 | 66% | | Six months ended June 30, 2025 | 50% | | Six months ended June 30, 2024 | 59% | - As of June 30, 2025, three distributors accounted for **32%**, **16%**, and **13%** of accounts receivable, and four suppliers accounted for **25%**, **24%**, **12%**, and **11%** of accounts payable[71](index=71&type=chunk)[72](index=72&type=chunk) [NOTE 12 — RELATED PARTY TRANSACTIONS](index=20&type=section&id=NOTE%2012%20%E2%80%94%20RELATED%20PARTY%20TRANSACTIONS) This note details transactions with related parties, including purchases from suppliers, royalty fees, and compensation arrangements with directors and officers - Purchases from United Systems, the principal handpiece supplier, were approximately **$0.8 million** for the six months ended June 30, 2025[73](index=73&type=chunk) - Royalty fees to the Director of Clinical Affairs were approximately **$0.2 million** for the six months ended June 30, 2025, in addition to consulting fees[75](index=75&type=chunk) - Leonard Osser (Vice Chairman) incurred **$0.1 million** in expenses each for his Employment and Consulting Agreements for the six months ended June 30, 2025[80](index=80&type=chunk) - Arjan J. Haverhals (Director) commenced a consulting agreement on January 1, 2025, with an annual fee of **$0.4 million** and **912,736 shares** to be issued after his CEO resignation[82](index=82&type=chunk)[84](index=84&type=chunk) [NOTE 13 — COMMITMENTS](index=21&type=section&id=NOTE%2013%20%E2%80%94%20COMMITMENTS) This note outlines the company's significant commitments, including purchase obligations for instruments, advances for development, and remaining lease terms - As of June 30, 2025, the company had a purchase commitment of approximately **$2.5 million** for **2,000 STA instruments**, with **$0.8 million** already paid as advances[85](index=85&type=chunk) - Approximately **$0.3 million** was recorded in advances for the development of the next-generation STA instrument[85](index=85&type=chunk) Weighted Average Remaining Lease Terms (June 30, 2025) | Lease Type | Remaining Term | | :-------------------------- | :------------- | | Finance leases | 4.50 years | | Operating leases | 1.75 years | [NOTE 14 — SUBSEQUENT EVENTS](index=22&type=section&id=NOTE%2014%20%E2%80%94%20SUBSEQUENT%20EVENTS) This note discloses significant events occurring after the reporting period, including the appointment of a new President and CEO and related compensation arrangements - Effective July 31, 2025, Eric Hines was appointed President and Chief Executive Officer and a director of the Company[89](index=89&type=chunk) - Mr. Hines' compensation includes a base salary of **$15 thousand per month** for the initial term and **$25 thousand per month** for the extended term[89](index=89&type=chunk) - He was granted options for **2,000,000 shares of Common Stock**, with **10% vesting** on the grant date and the remaining **90% vesting** in three equal annual installments[89](index=89&type=chunk) [Item 2. 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) This section provides management's perspective on the company's financial performance and condition, highlighting its biomedical technology focus, proprietary injection technologies, and strategic objectives. It details the results of operations for the three and six months ended June 30, 2025, compared to 2024, and discusses liquidity and capital resources, including the ongoing going concern issue [OVERVIEW](index=23&type=section&id=OVERVIEW) This section provides an overview of Milestone Scientific's business, focusing on its computer-controlled injection technologies and strategic transition to a commercially focused medical device company - Milestone Scientific is a biomedical technology company focused on pioneering computer-controlled injection technologies for medical and dental markets[92](index=92&type=chunk)[93](index=93&type=chunk) - The company's proprietary **DPS Dynamic Pressure Sensing Technology® System** is a platform for next-generation devices, enabling precise and virtually painless injections[94](index=94&type=chunk) - Milestone Scientific is transitioning to a commercially focused medical device company, aiming to expand the global footprint of its **CompuFlo Epidural** and **CathCheck System**, supported by a recent chronology-specific CPT Code for reimbursement[96](index=96&type=chunk)[97](index=97&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing product sales, gross profit, and expenses for the three and six months ended June 30, 2025 and 2024 [Three months ended June 30, 2025 compared to three months ended June 30, 2024](index=26&type=section&id=Three%20months%20ended%20June%2030%2C%202025%20compared%20to%20three%20months%20ended%20June%2030%2C%202024) This section compares the company's financial results for the three months ended June 30, 2025, against the same period in 2024, highlighting changes in sales, gross profit, and expenses Net Sales (Three Months Ended June 30) | Segment | 2025 | 2024 | Change | | :------ | :----------- | :----------- | :----------- | | Dental | $2,291,366 | $1,834,764 | $456,602 | | Medical | $32,100 | $19,000 | $13,100 | | Total sales, net | $2,323,466 | $1,853,764 | $469,702 | - Consolidated gross profit increased by approximately **$0.2 million** to **$1.6 million**[108](index=108&type=chunk) - Research and development expenses decreased by approximately **$0.3 million** to **$52,000**, primarily due to a delay in the development of the next-generation STA Single Tooth Anesthesia System[110](index=110&type=chunk) [Six months ended June 30, 2025 compared to six months ended June 30, 2024](index=27&type=section&id=Six%20months%20ended%20June%2030%2C%202025%20compared%20to%20six%20months%20ended%20June%2030%2C%202024) This section compares the company's financial results for the six months ended June 30, 2025, against the same period in 2024, detailing changes in sales, gross profit, and administrative expenses Net Sales (Six Months Ended June 30) | Segment | 2025 | 2024 | Change | | :------ | :----------- | :----------- | :----------- | | Dental | $4,472,536 | $4,076,189 | $396,347 | | Medical | $83,350 | $26,420 | $56,930 | | Total sales, net | $4,555,886 | $4,102,609 | $453,277 | - Consolidated gross profit increased by approximately **$0.2 million** to **$3.3 million**[113](index=113&type=chunk) - Selling, general and administrative expenses increased by approximately **$0.4 million** to **$6.3 million**, driven by increases in quality control, royalty expenses, travel expenses, and professional fees[114](index=114&type=chunk)[115](index=115&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, discussing cash flows, capital needs, and the going concern issue [Cash Flows](index=28&type=section&id=Cash%20Flows) This section summarizes the company's cash flow activities from operations, investing, and financing for the six months ended June 30, 2025 and 2024 Cash Flow Summary (Six Months Ended June 30) | Cash Flow Category | 2025 | 2024 | Change | | :----------------------------------- | :------------- | :------------- | :------------- | | Net cash used in operating activities | $(2,772,273) | $(434,473) | $(2,337,800) | | Net cash (used in) provided by investing activities | $(5,776) | $2,969,977 | $(2,975,753) | | Net cash provided by financing activities | $794,305 | $238,889 | $555,416 | | Net (decrease) increase in cash | $(1,983,744) | $2,774,393 | $(4,758,137) | [Operating Activities](index=28&type=section&id=Operating%20Activities) This section analyzes cash flows generated from or used in the company's primary business operations for the six months ended June 30, 2025 - Net cash used in operating activities increased by **$2.3 million** to **$(2.8 million)** for the six months ended June 30, 2025, primarily due to a **$2.3 million increase in net loss**[119](index=119&type=chunk) [Investing Activities](index=28&type=section&id=Investing%20Activities) This section details cash flows related to the acquisition and disposal of long-term assets and investments for the six months ended June 30, 2025 - Cash flows from investing activities decreased by **$3.0 million**, shifting from providing **$3.0 million** in 2024 to using **$(5,776)** in 2025[120](index=120&type=chunk) - This change was primarily due to the sale of **$3.0 million of marketable securities** in 2024, which did not recur in 2025 as the company had no marketable securities[120](index=120&type=chunk) [Financing Activities](index=28&type=section&id=Financing%20Activities) This section outlines cash flows from debt and equity transactions, including the issuance of convertible notes and public offerings, for the six months ended June 30, 2025 - Cash flows from financing activities increased by **$0.6 million** to **$0.8 million** for the six months ended June 30, 2025[121](index=121&type=chunk) - This increase was driven by the issuance of **$0.8 million in convertible notes** in 2025, compared to a **$0.2 million public placement offering** in 2024[121](index=121&type=chunk) [Consideration of Company's ability to continue as a going concern](index=29&type=section&id=Consideration%20of%20Company's%20ability%20to%20continue%20as%20a%20going%20concern) This section addresses the substantial doubt regarding the company's ability to continue as a going concern, citing recurring losses and plans for future financing - The company's recurring losses, accumulated deficit of **$131.5 million**, and significant cash used in operating activities (**$2.8 million** for H1 2025) raise substantial doubt about its ability to continue as a going concern for the next year[123](index=123&type=chunk)[124](index=124&type=chunk) - Management plans to seek additional equity or debt financing and generate positive cash flows from increased revenue and reduced expenses to address the going concern issue[125](index=125&type=chunk)[126](index=126&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Milestone Scientific Inc. is not required to provide detailed quantitative and qualitative disclosures about market risk - Milestone Scientific Inc. is exempt from providing detailed market risk disclosures due to its status as a **"smaller reporting company"**[127](index=127&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Principal Accounting Officer, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and concluded they were effective at a reasonable assurance level. No material changes were made to internal control over financial reporting during the period - Management concluded that the company's disclosure controls and procedures were **effective at a reasonable assurance level** as of June 30, 2025[129](index=129&type=chunk) - No material changes were made to internal control over financial reporting during the period ended June 30, 2025[130](index=130&type=chunk) [PART II—OTHER INFORMATION](index=29&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This part includes disclosures on legal proceedings, risk factors, unresolved staff comments, cybersecurity, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The report does not contain specific information regarding legal proceedings, as it is not explicitly detailed in the provided content for this item - No specific information regarding legal proceedings is provided in this section of the report[8](index=8&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company highlights new and ongoing risks, including potential adverse effects from changes to U.S. tariff and import/export regulations, particularly concerning sourcing from China and international sales. Government actions on tariffs and research grants may also impede research and capital raising efforts - Changes to United States tariff and import/export regulations may have a material adverse effect on the company's business, financial condition, and results of operations, especially concerning sourcing from China and international sales[132](index=132&type=chunk) - Government actions to impose tariffs and limit research grants and other funding may impede the company's ability to conduct research and raise capital[133](index=133&type=chunk) [Item 1B. Unresolved Staff Comments](index=30&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments to report - There are no unresolved staff comments[134](index=134&type=chunk) [Item 1C. Cybersecurity](index=31&type=section&id=Item%201C.%20Cybersecurity) The report indicates no specific disclosures regarding cybersecurity for this period - No specific cybersecurity disclosures are provided in this section[135](index=135&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is marked as "Not applicable," indicating no unregistered sales of equity securities or use of proceeds to report for the period - This item is marked as 'Not applicable'[136](index=136&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is marked as "Not applicable," indicating no defaults upon senior securities to report for the period - This item is marked as 'Not applicable'[137](index=137&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is marked as "Not applicable," indicating no mine safety disclosures are relevant to the company - This item is marked as 'Not applicable'[138](index=138&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) This item is marked as "Not applicable," indicating no other material information to report that is not covered elsewhere in the filing - This item is marked as 'Not applicable'[139](index=139&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications (Rule 13a-14(a) and Section 1350) and Inline XBRL documents - Exhibits include Rule 13a-14(a) Certification, Section 1350 Certifications, and various Inline XBRL documents[140](index=140&type=chunk) [Signatures](index=33&type=section&id=Signatures) This section provides the official signatures of the Chief Executive Officer and Vice President of Finance, certifying the accuracy of the report as of August 14, 2025 - The report was signed by Eric Hines, Chief Executive Officer, and Keisha Harcum, Vice President of Finance, on August 14, 2025[144](index=144&type=chunk)

Core Viewpoint - Milestone Scientific Inc. will host a conference call to discuss its financial results for Q2 2025 and corporate developments [1] Group 1: Conference Call Details - The conference call is scheduled for 8:00 AM Eastern Time on August 15, 2025 [1] - U.S. callers can dial toll-free 888-506-0062, while international callers can use +1 973-528-0011 with access code 470429 [2] - An audio replay will be available until August 29, 2025, accessible via 877-481-4010 for U.S. callers and +1 919-882-2331 for international callers with access code 52876 [3] Group 2: Company Overview - Milestone Scientific Inc. is a technology-focused medical research and development company specializing in innovative injection technologies for medical, dental, and cosmetic applications [4] - The company’s computer-controlled systems aim to enhance injection precision, efficiency, and patient comfort and safety [4] - The proprietary DPS Dynamic Pressure Sensing Technology is utilized to regulate flow rate and monitor pressure during subcutaneous drug delivery [4]

Core Insights - Milestone Scientific Inc. has appointed Jason Papes as Senior Vice President, Global Head of Sales and Marketing, effective immediately, bringing over 30 years of experience in the healthcare and medical technology sectors [1][2] Company Overview - Milestone Scientific Inc. is a technology-focused medical research and development company that specializes in innovative injection technologies and instruments for medical and dental applications [8] Leadership Experience - Jason Papes has extensive experience in sales, marketing, and business development within the healthcare industry, having held leadership roles at large-cap medical technology companies and entrepreneurial ventures [2][3] - His previous roles include executive positions at Stryker Imaging and Brainlab, where he led significant commercial expansions and market share growth [4] Strategic Initiatives - Papes joins Milestone at a critical time as the company rolls out the CompuFlo® Epidural System, having made progress in establishing procedural payment pathways, including Medicare Part B payment rates under CPT® code 0777T [5] - The company is also advancing growth initiatives in its dental segment, focusing on increasing adoption of the STA Single Tooth Anesthesia® System [6] Leadership Commentary - Eric Hines, CEO of Milestone Scientific, emphasized Papes' leadership experience and understanding of the provider and payer landscape as key assets for the company's growth phase [7] - Papes expressed excitement about joining a team committed to innovation and patient safety, aiming to broaden the company's reach and drive value for stakeholders [7]

Core Insights - Milestone Scientific Inc. has appointed Jason Papes as Senior Vice President, Global Head of Sales and Marketing, effective immediately [1] - Mr. Papes has over 30 years of experience in sales, marketing, and business development in the healthcare industry, with a strong background in orthopedics, neurology, pain management, and digital imaging [2] - His previous role was as Founder and Managing Partner of TEN20 Medical Distribution, where he led significant growth and earned multiple Distributor of the Year honors [3] - Mr. Papes has held executive positions at Stryker Imaging and Brainlab, contributing to substantial commercial expansions and market share growth [4] - His appointment comes at a crucial time for Milestone as it rolls out the CompuFlo® Epidural System and establishes payment pathways, including Medicare Part B rates [5] - The company is also focusing on growth in its dental segment, particularly the STA Single Tooth Anesthesia® System, where Mr. Papes will play a key role [6] - CEO Eric Hines emphasized Mr. Papes' leadership experience and market access strategies as vital for the company's growth phase [7] - Mr. Papes holds a Bachelor of Science in Biology and an International MBA, along with executive training in corporate strategy and complex sales [7] Company Overview - Milestone Scientific Inc. is a technology-focused medical research and development company that specializes in innovative injection technologies for medical and dental applications [8] - The company utilizes its proprietary DPS Dynamic Pressure Sensing Technology® to enhance the precision and safety of injections, aiming to improve patient comfort [8]

Core Insights - Milestone Scientific Inc. has appointed Eric C. Hines as the new Chief Executive Officer, effective immediately, to drive the company's next phase of commercial execution [1][3] Company Overview - Milestone Scientific Inc. is a technology-focused medical research and development company that specializes in innovative injection technologies for medical and dental applications [4] - The company utilizes its proprietary DPS Dynamic Pressure Sensing Technology platform to enhance the precision and efficiency of injections, thereby improving patient comfort and safety [4] Leadership Experience - Eric C. Hines brings over 25 years of leadership experience in scaling sales-driven enterprise software companies, with a notable track record in the healthcare sector [2] - Prior to joining Milestone, Hines served as President of North America at Ex Libris, where he successfully increased annual revenue from approximately $50 million to over $100 million [2] Strategic Goals - The company aims to accelerate the adoption of its CompuFlo technology, which has made significant progress in reimbursement, including Medicare Part B payment rates under CPT code 0777T [3] - Hines expressed a commitment to expanding Milestone's presence in both medical and dental markets, as well as pursuing new clinical indications and global opportunities [3] Market Opportunities - There are compelling opportunities identified in the dental segment, particularly with Milestone's STA system, which is noted for its differentiation in the market [3] - The company is focused on leveraging recent reimbursement achievements to support expanded commercial adoption of its technologies [3]

Core Insights - Milestone Scientific Inc. has initiated commercial sales of its CompuFlo® Epidural System at The Painless Center in Tenafly, New Jersey, marking a significant step in its market expansion [1][3] Company Overview - Milestone Scientific Inc. is a technology-focused medical research and development company that specializes in innovative injection technologies for medical and dental applications [5] - The company utilizes its proprietary DPS Dynamic Pressure Sensing® technology to enhance the precision and safety of injections [5] Product Details - The CompuFlo Epidural System provides real-time feedback to anesthesiologists, allowing for accurate identification of the epidural space, which can reduce complications and improve success rates in epidural procedures [3][4] - Clinical studies indicate that the CompuFlo system can significantly decrease false loss of resistance during procedures [3] Leadership and Adoption - Dr. Chi-Shin Jason Chiu, a double board-certified physician, leads The Painless Center and is recognized for his commitment to adopting advanced technologies to improve patient outcomes [2] - The adoption of the CompuFlo system by Dr. Chiu reflects its growing appeal and the company's expanding presence in the interventional pain market [3][4] Strategic Initiatives - Milestone Scientific is actively advancing its sales and marketing initiatives to increase awareness and accelerate the adoption of the CompuFlo system across the U.S. and international markets [4]

Core Insights - Milestone Scientific Inc. has appointed Shanth Thiyagalingam to its Board of Directors, effective May 14, 2025, bringing over 20 years of experience in commercial scaling and product innovation in the medical device and pharmaceutical industries [1][3]. Company Strategy - The appointment supports Milestone Scientific's strategy to enhance the adoption of its CompuFlo® Epidural System and expand access under favorable Medicare Part B payment rates for CPT code 0777T [3]. - The company aims to advance commercial initiatives through its Federal Supply Schedule (FSS) contract award [3]. Leadership Experience - Thiyagalingam has a proven track record in leading high-growth medical device companies, particularly in reimbursement strategy and securing CPT code approvals [3]. - He previously served as CEO of PainTEQ, where he transformed the company from a startup to a recognized innovator in interventional pain therapy, leading M&A initiatives and securing a Category 1 CPT code for a new therapy [4][5]. Previous Roles - Thiyagalingam held senior positions at Abbott, overseeing commercial strategy in the Asia-Pacific region, and at Nevro, where he significantly increased division revenue [5][6]. - His early career included roles at Stryker and St. Jude Medical, focusing on strategic growth and product launches across various regions [6]. Educational Background - He holds a Bachelor of Medical Science, a Master's in Marketing Management, and an MBA, and is a certified Gallup Strengths Coach [7]. Company Overview - Milestone Scientific Inc. specializes in developing innovative injection technologies for medical and dental applications, utilizing its proprietary DPS Dynamic Pressure Sensing Technology to enhance patient comfort and safety [8].