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]

Expands senior leadership team and board of directors to support next phase of growthROSELAND, N.J., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provides a business update and reported financial results for the second quarter ended June 30, 2025. Neal Goldman, Chairman of the Board, stated, “We are pleased with our revenue performance in the second quarter, deliveri ...

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-14053 Milestone Scientific Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended June 30, 2025 Delaware 13-3545623 State or other jurisdiction of Incor ...

ROSELAND, N.J., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE:MLSS), a leading developer of computerized drug delivery instruments, that provide painless and precise injections, today announced that it will host a conference call at 8:00 AM Eastern Time on Friday, August 15th, 2025, to discuss the company’s financial results for the second quarter ended June 30, 2025, as well as the company’s corporate progress and other developments. The conference call will be available via telephone b ...

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].

Core Viewpoint - Milestone Scientific Inc. is experiencing increased adoption of its CompuFlo® Epidural System, driven by favorable Medicare payment rates and a focus on expanding its presence in federal healthcare settings [2][3]. Business Update - The company reported a slight revenue decrease to approximately $2.2 million for the first quarter ended March 31, 2025, compared to the same period in 2024 [3]. - Medical revenue saw a significant increase to approximately $51,000 in Q1 2025 from $7,400 in Q1 2024, indicating growing traction for the CompuFlo technology [3]. - The company is actively engaging with Jurisdictional Medicare Administrative Contractors (JMACs) to expand its reimbursement framework, which is seen as a critical catalyst for adoption [2]. Financial Performance - Gross profit for Q1 2025 was $1.6 million, representing 74% of revenue, slightly down from 75% in Q1 2024 [4]. - The operating loss increased to approximately $(2.0) million in Q1 2025 from $(1.5) million in Q1 2024 [4]. - The net loss for Q1 2025 was approximately $(2.0) million, or $(0.02) per share, compared to a net loss of $(1.4) million, or $(0.02) per share, in Q1 2024 [5]. Strategic Initiatives - The company has secured a contract under the Federal Supply Schedule (FSS) to facilitate access to CompuFlo in federal healthcare settings, including the Department of Veterans Affairs and the Department of Defense [2]. - Milestone Scientific has maintained stable performance in its dental business while exercising financial discipline, including delaying non-essential R&D [2]. - The company secured $800,000 in convertible financing from board members, indicating strong confidence in its growth trajectory [2].

Part I [Item 1. Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Milestone Scientific reported **$9.1 million** total assets, a **$2.0 million** net loss, and **$1.0 million** cash used in operations for Q1 2025, with going concern risk noted [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$9.1 million**, liabilities increased to **$4.6 million**, and stockholders' equity decreased to **$4.5 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,246,387 | $3,258,058 | | Total current assets | $8,624,926 | $9,286,554 | | **Total assets** | **$9,088,016** | **$9,797,072** | | Total current liabilities | $4,443,633 | $3,744,127 | | **Total liabilities** | **$4,625,564** | **$3,964,372** | | **Total stockholders' equity** | **$4,462,452** | **$5,832,700** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 product sales were flat at **$2.2 million**, but increased operating expenses led to a wider net loss of **$2.0 million** compared to **$1.4 million** in Q1 2024 Condensed Consolidated Statements of Operations (Unaudited) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product sales, net | $2,232,420 | $2,248,845 | | Gross profit | $1,647,435 | $1,676,103 | | Total operating expenses | $3,645,288 | $3,141,171 | | Loss from operations | $(1,997,853) | $(1,465,068) | | **Net loss** | **$(1,994,586)** | **$(1,440,529)** | | Net loss per share | $(0.02) | $(0.02) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 saw **$1.0 million** cash used in operations, an improvement from Q1 2024, with minimal investing/financing activities, resulting in cash decreasing to **$2.2 million** Summary of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,008,089) | $(1,218,128) | | Net cash (used in) provided by investing activities | $(1,304) | $2,004,463 | | Net cash (used in) provided by financing activities | $(2,278) | $241,429 | | **Net (decrease) increase in cash** | **$(1,011,671)** | **$1,027,764** | | **Cash and cash equivalents at end of period** | **$2,246,387** | **$4,005,477** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes disclose a going concern warning due to **$130.0 million** accumulated losses, mitigated by cost-cutting and recent financing, with Dental segment profitable and Medical segment losing - The company has incurred total losses of **$130.0 million** since inception and had an operating loss of approximately **$2.0 million** for Q1 2025, raising substantial doubt about its ability to continue as a going concern[20](index=20&type=chunk) - Management's plans to alleviate the going concern doubt include increasing revenues, decreasing professional fees, delaying R&D on the next-generation STA system, and securing **$800,000** in related-party note financing in April 2025[21](index=21&type=chunk) Segment Operating Performance - Q1 2025 vs Q1 2024 | Segment | Product Sales, Net (Q1 2025) | Operating Income (Loss) (Q1 2025) | Product Sales, Net (Q1 2024) | Operating Income (Loss) (Q1 2024) | | :--- | :--- | :--- | :--- | :--- | | Dental | $2,181,170 | $179,354 | $2,241,425 | $625,510 | | Medical | $51,250 | $(421,250) | $7,420 | $(500,857) | | Corporate | - | $(1,755,957) | - | $(1,589,721) | - In April 2025, the company issued **$800,000** in promissory notes to three company directors to provide financing, with notes due in 2028 and convertible into common stock[77](index=77&type=chunk)[82](index=82&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 flat revenues at **$2.2 million**, net loss widening to **$2.0 million** due to increased SG&A and R&D, reiterating going concern risk and mitigation plans [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q1 2025 consolidated revenue was flat at **$2.2 million**, gross profit marginally decreased, while SG&A and R&D expenses significantly rose, leading to a **$2.0 million** operating loss Sales by Segment (Q1 2025 vs Q1 2024) | Segment | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Dental | $2,181,170 | $2,241,425 | $(60,255) | | Medical | $51,250 | $7,420 | $43,830 | | **Total sales, net** | **$2,232,420** | **$2,248,845** | **$(16,425)** | - SG&A expenses increased by approximately **$221,000**, primarily due to a **$368,000** rise in professional fees, warehousing, and travel expenses, partially offset by an **$81,000** decrease in salaries and benefits[100](index=100&type=chunk) - R&D expenses increased by approximately **$275,000**, mainly related to the development of the next-generation STA Single Tooth Anesthesia System, a project since delayed[101](index=101&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is strained, with cash decreasing to **$2.2 million** in Q1 2025, and **$130.0 million** accumulated losses raising going concern doubt, which management plans to mitigate via revenue growth, cost reduction, and recent financing Cash Flow Summary (Q1 2025 vs Q1 2024) | Cash Flow Activity | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,008,089) | $(1,218,128) | | Net cash (used in) provided by investing activities | $(1,304) | $2,004,463 | | Net cash (used in) provided by financing activities | $(2,278) | $241,429 | - The company's ability to continue as a going concern is in substantial doubt due to accumulated losses and negative operating cash flows, with cash at approximately **$2.2 million** and working capital of **$4.2 million** as of March 31, 2025[107](index=107&type=chunk) - Management believes that existing cash, combined with plans to increase revenue, decrease fees, and the **$800,000** in related-party financing from April 2025, will be sufficient to fund operations for the next twelve months[108](index=108&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk - As a "smaller reporting company," Milestone Scientific is not required to provide information regarding quantitative and qualitative disclosures about market risk[110](index=110&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[112](index=112&type=chunk) - No changes were made to the internal control over financial reporting during the three months ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, these controls[113](index=113&type=chunk) Part II [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces material risks from changes in U.S. tariff and import/export regulations, particularly due to sourcing from China, and government actions impacting costs and R&D - The company faces risks from potential changes in U.S. trade policies, treaties, and tariffs, which could have a material adverse effect on business as it sources important product elements from China[115](index=115&type=chunk) - Government actions, including tariffs and reductions in research grants, could increase business costs, impede research and development activities with collaborative partners, and make raising capital more challenging[116](index=116&type=chunk) [Other Items](index=26&type=section&id=Other%20Items) This section confirms no unresolved staff comments, cybersecurity incidents, unregistered equity sales, senior security defaults, or other material disclosures for the period - The company reports no unresolved staff comments (Item 1B), no cybersecurity incidents (Item 1C), and states that items concerning unregistered sales of equity securities (Item 2), defaults upon senior securities (Item 3), mine safety disclosures (Item 4), and other information (Item 5) are not applicable[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and Chief Accounting Officer certifications and Inline XBRL financial data files - The exhibits filed with this report include certifications from the Chief Executive Officer and Chief Accounting Officer, along with Inline XBRL instance and taxonomy documents[123](index=123&type=chunk)

Core Insights - Milestone Scientific Inc. is focusing on expanding its CompuFlo® Epidural System in the U.S. following favorable Medicare pricing assignments, which significantly broaden the addressable market for the technology [3][4] - The company reported a decrease in total revenue for 2024, amounting to approximately $8.6 million, down from $9.8 million in 2023, while e-commerce revenue showed growth [4][6] - The company is optimistic about its future growth prospects in both the dental and medical segments, with positive initial performance in Q1 2025 [3][7] Business Update - The company has established reimbursement infrastructure for the CompuFlo® Epidural System, with Medicare Part B payment rates assigned in multiple states, enhancing market access [3] - A contract for the Federal Supply Schedule (FSS) has been awarded, allowing federal medical facilities to purchase the CompuFlo system, targeting adoption within the U.S. Department of Veterans Affairs and other federal healthcare systems [3] - Strong commercial traction is noted in the private sector, with new rollouts at various pain management clinics and ambulatory surgery centers [3] Financial Performance - Revenue for 2024 was approximately $8.6 million, a decrease of about $1.2 million from 2023 [4] - E-commerce revenue reached approximately $5.1 million in 2024, compared to $4.8 million in 2023, indicating growth in this segment [4] - The company recorded an operating loss of $6.8 million in 2024, an improvement from a loss of $7.1 million in 2023, driven by higher-margin e-commerce sales [7] Market Position - The STA Single Tooth Anesthesia System remains a leader in computer-controlled local anesthetic delivery, with over 95 million injections administered to date [3] - The company is leveraging its leadership in the dental segment through an expanded direct-to-consumer e-commerce platform, which is enhancing margins and customer engagement [3] - The clinical response to the CompuFlo system has been positive, positioning the company to capitalize on growth opportunities in the medical field [3][7]