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 quarterly period ended June 30, 2026

☐	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)

Delaware		13-3545623
State or other jurisdiction of Incorporation or organization		(I.R.S. Employer Identification No.)

425 Eagle Rock Avenue, Suite 403, Roseland, NJ 07068

(Address of principal executive offices)

Registrant’s telephone number, including area code: 973-535-2717.

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Symbol		Name of each exchange on which registered
Common Stock, par value $.001 per share		MLSS		NYSE American

Securities registered pursuant to section 12(g) of the Act: NONE.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No

Indicate by check mark whether the registrant is a large, accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large, accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large, accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

Emerging Growth Company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of August 11, 2026, the registrant has a total of 88,739,185 shares of Common Stock, $0.001 par value outstanding.

MILESTONE SCIENTIFIC INC.

Form 10-Q

TABLE OF CONTENTS

	PART I—FINANCIAL INFORMATION	4

Item 1.	Condensed Consolidated Financial Statements	4

	Balance Sheets as of June 30, 2026 (Unaudited) and December 31, 2025	4

	Statements of Operations for the three and six months ended June 30, 2026, and 2025 (Unaudited)	5

	Statements of Changes in Stockholders’ Equity for the six months ended June 30, 2026 and 2025 (Unaudited)	6

	Statements of Cash Flows for the three and six months ended June 30, 2026 and 2025 (Unaudited)	7

	Notes to Condensed Consolidated Financial Statements (Unaudited)	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24

Item 4.	Controls and Procedures	25

	PART II—OTHER INFORMATION

Item 1.	Legal Proceedings	25

Item 1A.	Risk Factors	25

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	28

Item 3.	Defaults Upon Senior Securities	28

Item 4.	Mine Safety Disclosures	28

Item 5.	Other Information	28

Item 6.	Exhibits	28

Signatures		29

FORWARD-LOOKING STATEMENTS

When used in this Quarterly Report on Form 10-Q, the words “may”, “will”, “should”, “expect”, “believe”, “anticipate”, “continue”, “estimate”, “project”, “intend” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) regarding events, conditions and financial trends that may affect Milestone Scientific’s plans of operations, business strategy, results of operations and financial condition. Milestone Scientific wishes to ensure that such statements are accompanied by meaningful cautionary statements pursuant to the safe harbor established in the Private Securities Litigation Reform Act of 1995. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Milestone Scientific’s plans and objectives are based, in part, on assumptions involving the continued expansion of its business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive, and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Milestone Scientific. Although Milestone Scientific believes that its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate. Considering the significant uncertainties inherent in the forward-looking statements included herein, our history of operating losses that are expected to continue, requiring additional funding which we may be unable to raise when needed (which may force us to delay, curtail or eliminate commercialization efforts of our CompuFlo Epidural Computer Controlled Anesthesia System), the early stage operations of and relative lack of acceptance of our medical products, including our inability to recover our investment in slow-moving Medical finished goods inventory, relying exclusively on two third parties to manufacture our products, changes to our distribution arrangements exposes us to risks of interruption of marketing efforts and building new marketing channels, changes in our informal manufacturing arrangements made by the manufacturer of our products and disruptions at the manufacturing facility of our manufacturers, including shortages of or delays in obtaining chips and other components, exposes us to risks that may harm our business, raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights, our ability to generate revenue from sales will be materially impaired if physicians do not accept nor use our CompuFlo Epidural Computer Controlled Anesthesia System, exposure to the risks inherent in international sales and operations, including the cessation of revenue from China and the risk that U.S.-China trade tensions and tariffs may simultaneously increase our input costs and eliminate our ability to sell into the Chinese market, several legislative and regulatory changes and proposed changes regarding the healthcare system, including changes to reimbursement coverage of our products, that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval, developments by competitors may render our products or technologies obsolete or non-competitive, changes in United States policy regarding international trade, including the imposition of tariff and export controls on certain goods and products imported from China and other countries, which has resulted in retaliatory tariffs and other trade measures by China, the United States and other countries that will result in an increase in costs that we may not be able to offset or that otherwise adversely impact our results of operations, federal government actions that constrain collaborative research funding may reduce the pool of available research partners and increase the cost and difficulty of future product development efforts, our failure to regain compliance with the strict listing requirements of NYSE American, including the minimum stockholders’ equity requirement, may subject us to delisting and, if our stock were no longer listed on NYSE American, our stock price may decline, the liquidity of our securities likely would be impaired and our ability to raise additional capital may be limited, and ongoing geopolitical tensions, including conflicts in Eastern Europe and the Middle East, that have disrupted certain international markets served by the Company’s distributors and may continue to adversely impact demand and revenue, the inclusion of such information should not be regarded as a representation by Milestone Scientific or any other person that the objectives and plans of Milestone Scientific will be achieved. Prospective investors are cautioned that any forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. The actual results may differ materially from those included within the forward-looking statements because of various factors. Except as required by the federal securities laws, Milestone Scientific undertakes no obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise, to reflect events or circumstances occurring after the date of this Quarterly Report on Form 10-Q. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; CathCheck®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia Device®; and The Wand ®.

Part I- Financial Information

Item 1. Financial Statements

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

	June 30, 2026			December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents	$	2,066,770		$	1,112,642
Accounts receivable, net of allowance for credit losses of $10,000, respectively		1,003,063			680,620
Accounts receivable, related party		9,643			25,548
Accounts receivable		9,643			25,548
Other Receivables		40,276			-
Prepaid expenses and other current assets		633,953			468,792
Inventories		3,086,577			3,781,837
Advances on contracts		1,276,916			1,408,395
Total current assets		8,117,198			7,477,834
Furniture, fixtures and equipment, net		20,127			19,193
Intangibles, net		44,857			79,063
Right of use assets finance lease		48,977			55,811
Right of use assets operating lease		92,489			150,378
Other assets		24,150			24,150
Total assets	$	8,347,798		$	7,806,429

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,953,844		$	1,430,250
Accounts payable, related party		907,680			1,359,698
Accounts payable		907,680			1,359,698
Accrued expenses and other payables		956,530			995,206
Accrued expenses, related party		225,018			188,406
Accrued expenses		225,018			188,406
Other Current Liabilities		218,146			-
Current portion of finance lease liabilities		34,170			27,347
Current portion of operating lease liabilities		101,883			130,355
Total current liabilities		4,397,271			4,131,262
Non-current portion of finance lease liabilities		13,668			27,336
Non-current portion of operating lease liabilities		-			35,208
Convertible notes payable, related parties		465,982			800,000
Total liabilities	$	4,876,921		$	4,993,806

Commitments and contingencies		-			-

Stockholders’ equity
Common stock, par value $0.001; authorized 125,000,000 shares; 88,772,518 shares issued and 88,756,989 shares outstanding as of June 30, 2026; 80,486,449 shares issued and 80,453,116 shares outstanding as of December 31, 2025;	$	88,773		$	80,487
Additional paid in capital		139,968,127			137,418,974
Accumulated deficit		(135,674,507	)		(133,775,322	)
Treasury stock, at cost, 33,333 shares		(911,516	)		(911,516	)
Total stockholders’ equity	$	3,470,877		$	2,812,623
Total liabilities and stockholders’ equity	$	8,347,798		$	7,806,429

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

	Three Months Ended			Three Months Ended			Six Months Ended			Six Months Ended
	June 30, 2026			June 30, 2025			June 30, 2026			June 30, 2025
Product sales, net	$	2,841,038		$	2,323,466		$	5,003,071		$	4,555,886
Cost of products sold		930,871			705,860			1,528,880			1,290,845
Gross profit	$	1,910,167		$	1,617,606		$	3,474,191		$	3,265,041

Selling, general and administrative expenses	$	2,945,532		$	3,030,952		$	5,318,184		$	6,287,680
Research and development expenses		6,609			51,789			6,609			420,909
Depreciation and amortization expense		19,589			19,496			39,043			38,936
Total operating expenses	$	2,971,730		$	3,102,237		$	5,363,836		$	6,747,525

Loss from operations	$	(1,061,563	)	$	(1,484,631	)	$	(1,889,645	)	$	(3,482,484	)
Interest (expense) income, net		2,231			1,521			(9,540	)		4,788
Loss before provision for income taxes	$	(1,059,332	)	$	(1,483,110	)	$	(1,899,185	)	$	(3,477,696	)
Provision for income taxes		-			-			-			-
Net loss	$	(1,059,332	)	$	(1,483,110	)	$	(1,899,185	)	$	(3,477,696	)

Net loss per share applicable to common stockholders—
Basic and Diluted		(0.01	)		(0.02	)		(0.02	)		(0.04	)

Weighted average shares outstanding and to be issued—
Basic and diluted		93,126,415			82,049,984			87,386,906			81,903,323

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

FOR THREE AND SIX MONTHS ENDED JUNE 30, 2026 AND 2025

(UNAUDITED)

	Common Stock Shares		Common Stock Amount		Additional Paid in Capital		Accumulated Deficit			Treasury Stock			Total Stockholder Equity
Balance as of January 1, 2026		80,486,449	$	80,487	$	137,418,974	$	(133,775,322	)	$	(911,516	)	$	2,812,623
Stock based compensation						256,683								256,683
Common stock issued to board of directors for services						55,479								55,479
Net loss		-		-				(839,853	)		-			(839,853	)
Balance at March 31, 2026		80,486,449		80,487		137,731,136		(134,615,175	)		(911,516	)		2,284,932
Stock based compensation				-		254,098		-			-			254,098
Common stock issued to board of directors for services		310,606		311		99,689		-			-			100,000
Common Stock issued in private offerings net of conversion		6,662,962		6,663		1,513,977								1,520,640
Common Stock issued in private offerings for convertible notes		1,300,001		1,300		295,389								296,689
Common stock issued for consultant services		12,500		12		3,738								3,750
Common stock to be issued to employees for compensation						45,100								45,100
Common stock to be issued to consultants for compensation						25,000								25,000
Net loss		-		-		-		(1,059,332	)		-			(1,059,332	)
Balance at June 30, 2026		88,772,518	$	88,773	$	139,968,127	$	(135,674,507	)	$	(911,516	)	$	3,470,877

	Common Stock Shares		Common Stock Amount		Additional Paid in Capital			Accumulated Deficit			Treasury Stock			Total Stockholder Equity
Balance as of January 1, 2025		78,047,798	$	78,048	$	134,719,274		$	(128,053,106	)	$	(911,516	)	$	5,832,700
Stock based compensation		-		-		330,787			-			-			330,787
Common stock to be issued to employees for bonuses		-		-		293,551			-			-			293,551
Common stock issued to board of directors for services		182,584		182		(182	)		-			-			-
Net loss		-		-		-			(1,994,586	)		-			(1,994,586	)
Balance at March 31, 2025		78,230,382		78,230	$	135,343,430		$	(130,047,692	)	$	(911,516	)	$	4,462,452
Stock based compensation						159,679			-			-			159,679
Common stock issued for payment of consultant services		207,604		208		201,043			-			-			201,251
Common stock issued to board of directors for services		154,494		154		(154	)		-			-			-
Net loss									(1,483,110	)		-			(1,483,110	)
Balance at June 30, 2025		78,592,480	$	78,592	$	135,703,998		$	(131,530,802	)	$	(911,516	)	$	3,340,272

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR SIX MONTHS ENDED

(UNAUDITED)

	June 30, 2026			June 30, 2025
Cash flows from operating activities:
Net loss	$	(1,899,185	)	$	(3,477,696	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		4,837			4,026
Amortization of intangibles		34,206			34,910
Stock based compensation		566,261			490,465
Employees paid in stock		145,099			293,551
Expense paid in stock		28,750			201,251
Bad debt expense		4,014			8,525
Amortization of right-of-use asset		57,889			57,356
Changes in operating assets and liabilities:
Increase in accounts receivable		(326,457	)		(217,350	)
Decrease (increase) in accounts receivable, related party		15,905			(6,429	)
Increase in Other Receivable		(40,276	)		-
Decrease in inventories		695,260			(183,802	)
Decrease in advances on contracts		131,479			143,976
Increase in prepaid expenses and other current assets		(165,161	)		(72,938	)
Increase in accounts payable		523,594			429,192
Decrease (increase) in accounts payable, related party		(452,018	)		12,142
Decrease in accrued expenses		(38,676	)		(407,536	)
Increase (decrease) in accrued expenses, related party		54,894			(25,108	)
Increase in other liabilities		218,146			-
Decrease operating right of use lease asset		(56,846	)		(56,808	)
Net cash used in operating activities	$	(498,285	)	$	(2,772,273	)

Cash flows from investing activities:
Purchase of furniture, fixtures, and equipment	$	(5,771	)	$	(5,776	)
Net cash used in investing activities	$	(5,771	)	$	(5,776	)

Cash flows from financing activities:
Proceeds from the Private Placement	$	1,797,700		$	-
Proceeds from convertible notes payable		-			800,000
Payments of equity issuance costs		(332,671	)		-
Payments finance lease obligations		(6,845	)		(5,695	)
Net cash provided by financing activities	$	1,458,184		$	794,305

Net increase (decrease) in cash and cash equivalents	$	954,128		$	(1,983,744	)
Cash and cash equivalents at beginning of period		1,112,642			3,258,058
Cash and cash equivalents at end of period	$	2,066,770		$	1,274,314

Six Months Ended

June 30, 2026

Six Months Ended

June 30, 2025

Supplemental disclosure of noncash financing activities

Convertible notes payable converted into common stock

350,000

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MILESTONE SCIENTIFIC INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

NOTE 1 — ORGANIZATION AND BUSINESS

All references in this report to “Milestone Scientific,” “us,” “our,” “we,” the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., and Milestone Innovations Inc. and Milestone Education LLC (all described below), unless the context otherwise indicates. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia System®; and The Wand ®.

Milestone Scientific is a biomedical technology company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical and dental use. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets. We believe our technologies are proven and well established.

We have focused our resources on redefining the worldwide standard of care for injection techniques by making the experience more comfortable for the patient by reducing the anxiety and stress of receiving injections from the healthcare provider. Our computer-controlled injection devices make injections precise, efficient, and virtually painless.

Milestone Scientific has developed a proprietary computer-controlled anesthetic delivery system based on our DPS Dynamic Pressure Sensing Technology® platform. The technology is designed to address the limitations of the traditional manual syringe by enabling precise, controlled delivery of anesthetic and other injectable drugs, as well as fluid aspiration. Our proprietary DPS technology regulates flow rate and continuously monitors pressure at the tip of the needle, providing healthcare practitioners with greater control during injections. The platform supports a range of dental and medical applications, including local anesthesia, subcutaneous drug delivery, and regional anesthesia procedures. In particular, the technology has specific medical applications in epidural procedures, where dynamic pressure sensing can assist healthcare practitioners in identifying the epidural space. DPS serves as Milestone Scientific’s core technology platform and provides the foundation for the development of next-generation drug delivery and injection devices.

Our device, using The Wand^®, a single use disposable handpiece, is marketed in dentistry under the trademark CompuDent^®, and STA Single Tooth Anesthesia System^® and is suitable for all dental procedures that require local anesthetic. The dental devices currently are sold in the United States, Canada and in over 33 other countries. Milestone Scientific also has 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo^® Epidural Computer Controlled Anesthesia System in the lumbar, thoracic and cervical thoracic junction of the spine region. In addition, Milestone Scientific has obtained CE mark approval and can be marketed and sold in most European countries.

Our recent receipt of technology-specific CPT Code for the Company’s technology by the American Medical Association marks an important milestone that could increase the potential number of anesthesia pain management clinics adopting the CompuFlo instrument. A CPT code expands the potential for reimbursement of epidural procedures in pain management utilizing the CompuFlo Epidural System., which we believe should help accelerate the commercial roll-out of CompuFlo in the United States.

NOTE 2 — GOING CONCERN AND LIQUIDITY

Our financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company on a going concern basis. The going concern basis assumes that assets are realized, and liabilities are extinguished in the ordinary course of business at amounts disclosed in the financial statements.

The Company has incurred total losses since its inception of $135.7 million. The Company’s operating losses were approximately $1.1 and $1.9 million for the three and six months ended June 30, 2026. On June 30, 2026, Milestone Scientific had cash and cash equivalents of approximately $2.1 million and working capital of approximately $3.7 million. For the six months ended June 30, 2026, we had cash flows used in operating activities of approximately $498,000. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

On April 20, 2026, the Company completed a private placement of 7,962,963 units of common stock and warrants to purchase common stock at a purchase price of $0.27 per unit, generating net proceeds of approximately $1.81 million, consisting of cash and a reduction in outstanding principal and accrued interest of the Company’s outstanding convertible notes, the holders of which applied such principal amounts toward the purchase of units in the offering in lieu of cash (the “Private Placement”).

Each warrant entitles the holder to purchase one share of common stock at an exercise price of $0.3375 per share and is exercisable for a period of three years. If exercised in full, the warrants could provide up to approximately $2.69 million in additional gross proceeds; however, there can be no assurance that any or all of the warrants will be exercised.

The Company’s recurring losses from operations, negative cash flows, and accumulated deficit raise substantial doubt about its ability to continue as a going concern. The completion of the private placement in April 2026 has improved the Company’s liquidity position; however, the Company’s ability to continue as a going concern is dependent upon its ability to generate sufficient revenue, manage operating expenses, and, if necessary, obtain additional financing.