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
2
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 ®.
3
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.
4
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.
5
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.
6
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.
7
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.
8
NOTE
3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
1.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of Milestone Scientific Inc. have been prepared
in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial
information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and
disclosures required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed
consolidated financial statements include all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation
of the Company’s financial position and results of operations for the interim periods presented. Interim results are not necessarily
indicative of the results that may be expected for the full year or any subsequent period. These unaudited condensed consolidated financial
statements should be read in conjunction with the audited consolidated financial statements and related notes for the year ended December
31, 2025, included in the Company’s Annual Report on Form 10-K.
2.
Basic and Diluted Net Loss Per Common Share
Milestone
Scientific presents “basic” earnings (loss) per common share and, if applicable, “diluted” earnings (loss)
per common share applicable to common stockholders pursuant to the provisions of ASC 260, “Earnings per Share”. Basic
earnings (loss) per common share is calculated by dividing net income or loss applicable to common stockholders by the weighted
average number of common shares outstanding and to be issued common shares as follows: 93,126,415 and 87,386,906 for
the three and six months ended June 30, 2026 and 82,049,984 and 81,903,323 for
the three and six months ended June 30, 2025, respectively. The calculation of diluted earnings per common share is like that of
basic earnings per common share, except that the denominator is increased to include the number of additional common shares that
would have been outstanding if all potentially dilutive common shares, such as those issuable upon the exercise of stock options and
warrants, were issued during the period. Since Milestone Scientific had net losses in the three and six months ended June 30, 2026,
and 2025, the assumed effects of the exercise of potentially dilutive outstanding stock options, unissued restricted stock awards
(“RSA”), unconverted convertible notes and warrants were not included in the calculation as their effect would have been
anti-dilutive. Such outstanding options, RSA’s unconverted convertible notes, and warrants totaled 15,302,498 and 3,792,211 for
the three and six months ended June 30, 2026 and 2025, respectively.
3.
Recent Accounting Pronouncements
Recently
Issued Accounting Pronouncement
In
November 2024, the Financial Accounting Standards Board, “FASB”, issued Accounting Standards Update “ASU” 2024-03,
Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), to improve the disaggregation
of expenses within the consolidated statement of operations. The amendments in ASU 2024-03 require disclosures, in the notes to the consolidated
financial statements, specified information about certain costs and expenses. The amendments require that at each interim and annual
reporting period an entity disclose (a) employee compensation, (b) depreciation, and (c) intangible asset amortization included in each
relevant expense caption; include certain amounts that are already required to be disclosed under current generally accepted accounting
principles (GAAP) in the same disclosure as the other disaggregation requirements; and disclose a qualitative description of the amounts
remaining in relevant expense captions that are not separately disaggregated quantitatively. The amendments in ASU 2024-03 are effective
January 1, 2027, and effective for interim periods beginning January 1, 2028. Early adoption is permitted for annual financial statements
that have not yet been issued or made available for issuance. The Company will evaluate the impact of ASU 2024-03 on its financial statements.
4. Warrants
The Company accounts for warrants as either
equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable
authoritative guidance in Financial Accounting Standards Board (“FASB”) ASC 480, “Distinguishing
Liabilities from Equity” (“ASC 480” ) and ASC 815, “Derivatives and Hedging”
(“ASC 815” ).
The assessment considers whether the warrants
are freestanding financial instruments pursuant to ASC 480, whether they meet the definition of a liability
pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including
whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require
“net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity
classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and
as of each subsequent quarterly period end date while the warrants are outstanding. For issued or modified warrants that meet all of
the criteria for equity classification, the warrants are required to be recorded as a component of equity at the time of issuance.
For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are
required to be recorded as liabilities at their initial fair value on the date of issuance, and each balance sheet date thereafter.
Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations.
Management concluded that its warrants qualify for equity accounting treatment.
9
NOTE
4 — INVENTORIES, NET
Inventories
consist of the following:
SCHEDULE OF INVENTORIES
June 30, 2026
December 31, 2025
Dental finished goods
$ 2,914,209
$ 3,598,270
Medical finished goods
81,511
108,975
Inventory finished goods
81,511
108,975
Component parts and other materials
90,857
74,592
Total inventories
$ 3,086,577
$ 3,781,837
The
Company had an allowance on slow moving Medical finished goods due to the slow adoption of the epidural instruments and handpieces
for approximately $ 504,000
and $ 1.1
million as of June 30, 2026, and December 31, 2025, respectively. The decrease in the allowance was primarily attributable to the disposal of fully reserved inventory and resulted
in an immaterial impact on the Company’s results of operations for the period.
NOTE
5 — ADVANCES ON CONTRACTS
The
advances on contracts represent funding for future Single Tooth Anesthesia System® (STA) devices, epidural instruments, and epidural replacement parts. The balance of
the advances as of June 30, 2026 and December 31, 2025, is approximately $ 1.3 and $ 1.4 million, respectively. The advance is classified
as current based on the estimated annual usage of the underlying inventory.
NOTE
6 — STOCKHOLDERS’ EQUITY
WARRANTS
On
April 20, 2026, Company entered into a securities purchase agreement (the “Purchase
Agreement”) with the purchasers named therein (the “Purchasers”), for the private placement (the “Private Placement”)
of an aggregate of 7,962,963 units (the “Units”), with each Unit consisting of (i) one share of the Company’s common
stock, par value $ 0.001 per share (the “Common Stock”), and (ii) one warrant to purchase one share of Common Stock (each,
a “Warrant”). The purchase price paid by the Purchasers for each Unit was $ 0.27 (the “Per Unit Purchase Price”).
Certain directors and officers participated in the Private Placement, purchasing an aggregate of $ 150,000 of Units for cash and converting
into Units a total of $ 351,000 in respect of convertible notes evidencing loans they made to the Company in 2025,
in each case at the same price and (except for such conversion of loans) on the same terms as all other securities offered in the Private
Placement.
Each
Warrant has an exercise price equal to 125 %
of the Per Unit Purchase Price per share, or $ 0.3375
per warrant share, and will be exercisable after six (6) months from the closing and prior to the third anniversary of the closing
for cash only. As of June 30, 2026, outstanding warrants were 7,962,962.
The
following table summarizes information about Warrants for the six month periods ending June 30, 2026 .
SCHEDULE
OF INFORMATION ABOUT SHARES ISSUABLE UNDER WARRANTS OUTSTANDING
Number of
Warrants
Weighted
Averaged
Exercise
Price $
Weighted
Average
Remaining
Life
Aggregate
Intrinsic
Options
Value $
Warrants outstanding at January 1, 2026
-
-
-
-
Granted during 2026
7,962,963
$ 0.3375
3.00
-
Warrants outstanding June 30, 2026
7,962,963
$ 0.3375
2.81
-
10
SHARES
TO BE ISSUED
As
of June 30, 2026, and 2025, there were 3,596,260 and 3,076,871 shares to be issued, respectively, whose issuance has been deferred under
the terms of employment and consulting agreements with officers and directors and other employees of Milestone Scientific. Such shares
will be issued to each party upon termination of their employment or other relationship with the Company.
As
of June 30, 2026 and 2025 there were 1,088,369 and 631,792 respectively, shares to be issued to
non-employees for services rendered. The number of shares was fixed by contract prior to the date of grant, subject to performance, and
were fully earned upon the grant date. Such shares will be issued to each party upon termination of their relationship with the Company.
The
following table summarizes information about shares to be issued for the six month periods ending June 30, 2026 and 2025.
SCHEDULE OF SHARES TO BE ISSUED
June 30, 2026
June 30,
2025
Shares-to-be-issued, outstanding January 1, 2026 and 2025, respectively
4,449,403
3,393,017
Shares-to-be-issued, outstanding beginning balance
4,449,403
3,393,017
Granted in current period
405,682
315,646
Issued in current period
( 170,455 )
-
Shares-to be issued outstanding June 30, 2026 and 2025, respectively
4,684,630
3,708,663
Shares-to be issued outstanding ending balance
4,684,630
3,708,663
NOTE
7 — STOCK OPTION PLANS
The
Milestone Scientific Inc., Amended and Restated 2020 Equity Incentive Plan (the “2020 Plan”) provides for awards of
restricted common stock, restricted stock units, options to purchase shares and other awards. At June 30, 2026, the maximum number
of shares that could be issued thereunder was 11,500,000 shares of common stock., On July 27, 2026, the stockholders of the Company
amended the 2020 Plan to increase the maximum number of shares that can be issued thereunder to 28,750,000 shares of common stock.
The plan expires in June 2031. Options may be granted to employees, directors, and consultants of Milestone Scientific for the
purchase of shares of common stock at a price not less than the fair market value of common stock on the date of grant. Generally,
options become exercisable over a 3 -year
period from the grant date and expire 5
years after the date of grant.
Additionally on April 30, 2026, the Compensation Committee recommended the grant of performance-based restricted
stock units (“PRSUs”) to certain officers of the Company. As all of the PRSUs are to have the same performance milestones
and other terms and conditions (other than the actual grant amounts), the Compensation Committee established a sub-plan of the 2020 Plan
(the “Sub-Plan”) as the framework together with the 2020 Plan for the award of PRSUs (each, an “Award” and collectively,
“Awards”), with a fixed pool of PRSUs. The total aggregate number of shares of common stock that to be issued under 2020 Plan
will be adjusted to 28,734,635 , an increase of 17,234,635 shares as a result of the approval of the Sub-Plan (the “Aggregate Pool”).
The recommendation of the award of PRSUs under the Sub-Plan was subject to stockholder approval to increase the number of shares covered
by the 2020 Plan to account for the recommendation to issue PRSU awards under the Sub-Plan, which increase was approved by the stockholders at the Company’s Annual Meeting on July 27, 2026 as aforesaid.
On
April 30, 2026 (the “Effective Date”), the Compensation Committee of the Board of Directors (the “Compensation
Committee”) of the Company approved a one-time stock option exchange program (the “Exchange Program”) for
outstanding stock options granted under the Company’s 2020
Plan and the applicable award agreements thereunder, held by Eric Hines, the President and Chief Executive Officer, and
Jason Papes, the Senior Vice President, Global Head of Sales and Marketing, of the Company (“Eligible Options”), all of
which have exercise prices that exceed the current fair market value of the Company’s common stock (the “Common
Stock”). The Exchange Program was undertaken in accordance with, and as expressly permitted by, the 2020 Plan and the
applicable award agreements thereunder, and provides that such eligible participants may voluntarily elect to surrender some or all
of their Eligible Options in exchange for newly granted stock options to purchase shares of the Company’s Common Stock, at an
exercise price reduced to $ 0.27
per share (the “Reduced Exercise Price, which exercise price equals the closing price of the Company’s Common Stock on
the Effective Date (the “Repricing”). All of the Eligible Options (i) were granted under the 2020 Plan, (ii) as of the
Effective Date, were held by continuing employees, (iii) had not previously been repriced and (iv) had an exercise price per share
greater than the Reduced Exercise Price (the “Repriced Options”). The Repriced Options have the same vesting
commencement date and expiration date as the respective Eligible Options surrendered. In addition, for each Repriced Option, the
vesting schedule was modified such that the number of shares vesting on the applicable vesting commencement date was increased from 200,000
to 500,000
shares, constituting twenty-five percent ( 25 %)
of the total number of shares subject to the Repriced Option, and providing for the vesting of the remainder of the shares subject
to the Repriced Options in two equal tranches of 750,000
shares on the first and second anniversaries of the applicable vesting commencement date rather than over three years from the
vesting commencement date, subject to the continued employment of the grantee on the applicable vesting date and compliance with
certain restrictive covenants. No other changes were made to the Repriced Options as a result of the Repricing.
The
number of shares of Common Stock issuable upon the exercise of each of the Repriced Options ( 2.0 million shares), and the total number
of shares underlying all Repriced Options ( 4.0 million shares), remains the same number of shares as underlying the respective Eligible
Options surrendered, in accordance with the 2020 Plan. The Eligible Options previously had exercise prices ranging from $ 0.46 to $ 0.50
per share and were granted in August 2025.
The Company accounted for each Repriced Option as a modification under
ASC 718, Compensation—Stock Compensation , and the Company measured the fair value of the modified awards immediately before
and immediately after the modification using the Black-Scholes-Merton option-pricing model.
The Company estimated the fair value of the Repriced
Options immediately before the Effective Date using the Black-Scholes option pricing model with the following assumptions: a risk-free
interest rate of 3.86 %, expected volatility of 82.3 % (based on the Company’s historical volatility over the expected term),
an expected term of 5.2 years, a dividend yield of 0 %, and a stock price ranging from $ 0.45 to $ 0.50 .
The Company estimated the fair value of the Repriced
Options immediately after the Effective Date using the Black-Scholes option pricing model with the following assumptions: a risk-free
interest rate of 1.75 %, expected volatility of 86.6 % (based on the Company’s historical volatility over the expected term),
an expected term of 5.7 years, a dividend yield of 0 %, and a stock price of $ 0.27 .
As a result of the measurement of the modified awards
immediately before and after the modification date, the Company determined an incremental fair value of $ 146,000 related to the modified
awards. This incremental fair value of $ 146,000 is being recognized as compensation expense over the remaining requisite service period
of the replacement awards. Any unrecognized compensation cost associated with the original, canceled awards continues to be amortized
over the original vesting periods.
Milestone Scientific recognizes compensation expenses over the requisite
service period and in the case of performance-based options over the period of the expected performance. For the three and six months
ended June 30, 2026, Milestone Scientific recognized approximately $ 239,000
and $ 496,000 of total employee compensation cost, respectively, recorded in general and
administrative expenses on the statement of operations. For the three and six months ended June 30, 2025, Milestone Scientific recognized
approximately $ 158,000 and $ 329,000 of total employee compensation cost, respectively, recorded in general and administrative expenses
on the statement of operations.
As
of June 30,2026, there was approximately $ 943,000 of total unrecognized compensation cost related to non-vested options. Milestone Scientific expects to recognize these costs over a
weighted average period of 2.1 years.
A
summary of option activity for employees under the plans and changes during the six months ended June 30, 2026 is presented below:
SCHEDULE OF STOCK OPTION ACTIVITY
Number of Options
Weighted Averaged Exercise Price $
Weighted Average Remaining Contractual Life (Years)
Aggregate Intrinsic Options Value $
Options outstanding at January 1, 2026
6,032,175
1.15
8.13
-
Granted during 2026 (1)
4,000,000
0.27
-
-
Forfeited or expired during 2026 (1)
( 4,032,175 )
0.50
-
-
Options outstanding June 30, 2026
6,000,000
1.00
8.15
200,000
Exercisable, June 30, 2026
3,000,000
1.73
6.48
50,000
(1) Includes 4,000,000
stock options exchanged pursuant to the Exchange Program
11
A
summary of option activity for non-employees under the plans and changes during the six months ended June 30, 2026 is presented below:
SCHEDULE OF STOCK OPTION ACTIVITY
Number of Options
Weighted Averaged Exercise Price $
Weighted Average Remaining Contractual Life (Years)
Aggregate Intrinsic Options Value $
Options outstanding at January 1, 2026
83,330
1.59
2.40
-
Forfeited or expired during 2026
( 16,666 )
3.94
-
-
Options outstanding June 30, 2026
66,664
1.00
2.45
-
Exercisable, June 30, 2026
49,994
1.02
2.10
-
For the three and six months ended June 30, 2026 Milestone Scientific recognized
approximately $ 1,200 and $ 2,400 expense related to non-employee options, respectively. For the three and six months
ended June 30, 2025 Milestone Scientific recognized approximately $ 1,400 and $ 8,000 expense related to non-employee options, respectively.
A
summary of restricted stock under the plans and changes during the six months ended June 30, 2026 is presented below:
SCHEDULE OF RESTRICTED STOCK
Number of Shares
Weighted Average
Grant-Date Fair
Value per Award
Non-vested as January 1, 2026
-
-
Granted
681,818
0.33
Vested
( 340,910 )
0.33
Non-vested as June 30, 2026
340,908
0.33
On
January 1, 2026, the Company entered into restricted stock agreements with members of the Board of Directors of the Company. The
Company granted 681,818
restricted stock awards with a fair market value of $ 0.33
per share. Such
restricted stock vests as follows: 25% on the grant date in January 1, 2026, and the remaining 75% vesting 25% each on April 1,
2026, July 1, 2026 and October 1, 2026 . These awards vest immediately upon a change of control as defined in the
agreements.
For
the three months ended June 30, 2026 and 2025, the Company recognized approximately $ 56,000
and $ 1,500
for restricted stock expenses recorded in general and administrative expenses on the statement of operation. For the six months
ended June 30, 2026 and 2025, the Company recognized approximately $ 112,000 and $ 155,500 for restricted stock expenses recorded in
general and administrative expenses on the statement of operation.
As of June 30, 2026 there was $ 113,000
of unrecognized compensation expense related to these awards.
NOTE
8 — INCOME TAXES
The
utilization of Milestone Scientific’s net operating losses may be subject to a substantial limitation due to the “change
of ownership provisions” under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result
in the expiration of the net operating loss carry forwards before their utilization. Milestone Scientific has established a 100 % valuation
allowance for all its deferred tax assets due to uncertainty as to their future realization.
NOTE
9 — SEGMENT AND GEOGRAPHIC DATA
Operating
segments are reported in a manner consistent with the internal reporting provided to the chief operating decision maker. The chief operating
decision maker, who is responsible for allocating resources and assessing performance of the operating segments, has been identified
as the Chief Executive Officer (the “CODM”). The Company conducts its business through two reportable segments: Dental and
Medical. These segments offer different products and services to different customer bases. The CODM assesses the financial performance
of the segment and decides how to allocate resources based on Product sales, net, and operating income (loss).
The
Company provides general corporate services to its segments; however, these services are not considered when making operating decisions
and assessing segment performance. These services are reported under “Corporate Services” below, and these include costs
associated with executive management, investor relations, patents, trademarks, licensing agreements, new instruments developments, financing
activities and public company compliance.
12
The
following tables present information about our reportable and operating segments for the three and six months ended June 30, 2026, and
2025:
SCHEDULE OF REPORTABLE AND OPERATING SEGMENTS
Corporate
Dental
Medical
Total
Three Months ended June 30, 2026
Corporate
Dental
Medical
Grand Total
Product sales, net
-
2,734,638
106,400
2,841,038
Cost of products sold
-
906,033
24,838
930,871
Gross Margin
-
1,828,605
81,562
1,910,167
Salaries & employee benefits
257,658
396,390
209,249
863,297
Stock-based compensation expense
254,098
-
-
254,098
Royalty expense
-
145,430
5,320
150,750
Marketing
( 7,935 )
70,049
45,456
107,570
Rent & occupancy costs
16,722
8,533
5,333
30,588
Consultants and professional services fees
730,328
34,121
52,810
817,259
Insurance
41,248
45,554
40,284
127,086
Warehousing expense
2,458
152,147
20,776
175,381
Regulatory expense
119,332
8,648
2,312
130,292
Travel expense
22,458
39,628
25,225
87,311
Research and development expense
-
6,609
-
6,609
Depreciation and amortization expense
19,589
-
-
19,589
Other segment items
71,549
124,222
6,129
201,900
Total operating expenses
1,527,505
1,031,331
412,894
2,971,730
Operating income (loss)
( 1,527,505 )
797,274
( 331,332 )
( 1,061,563 )
Corporate
Dental
Medical
Total
Three Months ended June 30, 2025
Corporate
Dental
Medical
Grand Total
Product sales, net
-
2,291,366
32,100
2,323,466
Cost of products sold
-
704,866
994
705,860
Gross Margin
-
1,586,500
31,106
1,617,606
Salaries & employee benefits
206,777
440,463
192,733
839,973
Stock-based compensation expense
159,678
-
-
159,678
Royalty expense
-
118,174
1,605
119,779
Marketing
10,156
48,047
19,907
78,110
Rent & occupancy costs
21,703
13,852
8,657
44,212
Consultants and professional services fees
698,388
83,134
119,069
900,591
Insurance
40,503
45,225
40,078
125,806
Warehousing expense
5,033
106,685
17,188
128,906
Regulatory expense
263,931
66,144
3,087
333,162
Travel expense
12,005
25,870
35,330
73,205
Research and development expense
-
47,089
4,700
51,789
Depreciation and amortization expense
19,496
-
-
19,496
Other segment items
79,433
136,193
11,904
227,530
Total operating expenses
1,517,103
1,130,876
454,258
3,102,237
Operating income (loss)
( 1,517,103 )
455,624
( 423,152 )
( 1,484,631 )
13
Corporate
Dental
Medical
Total
Six Months ended June 30, 2026
Corporate
Dental
Medical
Grand Total
Product sales, net
-
4,789,071
214,000
5,003,071
Cost of products sold
-
1,490,614
38,266
1,528,880
Gross Margin
-
3,298,457
175,734
3,474,191
Salaries & employee benefits
434,908
815,841
437,554
1,688,303
Stock-based compensation expense
566,261
-
-
566,261
Royalty expense
-
235,668
10,700
246,368
Marketing
23,455
106,416
51,424
181,295
Rent & occupancy costs
36,455
25,599
15,999
78,053
Consultants and professional services fees
991,573
62,838
154,688
1,209,099
Insurance
83,074
91,647
80,904
255,625
Warehousing expense
3,741
283,243
18,177
305,161
Regulatory expense
208,138
12,133
4,625
224,896
Travel expense
46,848
64,957
36,036
147,841
Research and development expense
-
6,609
-
6,609
Depreciation and amortization expense
39,043
-
-
39,043
Other segment items
144,884
260,397
10,001
415,282
Total operating expenses
2,578,380
1,965,348
820,108
5,363,836
Operating income (loss)
( 2,578,380 )
1,333,109
( 644,374 )
( 1,889,645 )
Corporate
Dental
Medical
Total
Six Months ended June 30, 2025
Corporate
Dental
Medical
Grand Total
Product sales, net
-
4,472,536
83,350
4,555,886
Cost of products sold
-
1,289,761
1,084
1,290,845
Gross Margin
-
3,182,775
82,266
3,265,041
Salaries & employee benefits
323,885
881,961
398,847
1,604,693
Stock-based compensation expense
490,466
-
-
490,466
Royalty expense
-
228,102
4,168
232,270
Marketing
14,417
131,676
44,227
190,320
Rent & occupancy costs
34,411
26,373
16,483
77,267
Consultants and professional services fees
1,783,082
140,795
261,359
2,185,236
Insurance
83,375
94,222
82,514
260,111
Warehousing expense
6,238
219,000
25,961
251,199
Regulatory expense
328,821
82,994
5,399
417,214
Travel expense
16,479
57,538
65,292
139,309
Research and development expense
-
411,896
9,013
420,909
Depreciation and amortization expense
38,936
-
-
38,936
Other segment items
152,951
273,239
13,405
439,595
Total operating expenses
3,273,061
2,547,796
926,668
6,747,525
Operating income (loss)
( 3,273,061 )
634,979
( 844,402 )
( 3,482,484 )
June 30, 2026
Dental
Medical
Corporate
Total
Total Assets
$ 5,271,616
$ 381,309
$ 2,694,873
$ 8,347,798
5,271,616
381,309
2,694,873
8,347,798
December 31, 2025
Dental
Medical
Corporate
Total
Total Assets
$ 5,861,323
$ 394,267
$ 1,550,839
$ 7,806,429
5,861,323
394,267
1,550,839
7,806,429
14
NOTE
10 – CONCENTRATIONS
Milestone
Scientific has informal arrangements with third-party U.S. manufacturers of the STA devices and epidural instruments pursuant to which
they manufacture these products under specific purchase orders that contain advance payments for long lead items for production. Advances
on contracts have been classified as current at June 30, 2026 and December 31, 2025. The termination of the manufacturing relationship
with any of these manufacturers could have a material adverse effect on Milestone Scientific’s ability to produce and sell its
products. Although alternate sources of supply exist, and new manufacturing relationships could be established, Milestone Scientific
would need to recover its existing tools or have new tools produced. Establishment of new manufacturing relationships could involve significant
expense and delay. Any curtailment or interruption of the supply, because of the termination of such a relationship, would have a material
adverse effect on Milestone Scientific’s financial condition, business, and results of operations.
On
January 3, 2023, the Company launched an E-Commerce platform selling and shipping STA instruments and handpieces
directly to dental offices and dental groups within the U.S. For the three months ended June 30, 2026, E-Commerce accounted for 41 % of
net product sales, and no international distributors accounted for over 10 % of net product sales. For the three months ended June 30,
2025, E-commerce accounted for 53 % of net product sales, and one international distributor accounted for 10 % of net product sales. For
the six months ended June 30, 2026, E-Commerce accounted for 45 % of net product sales, and no international distributors accounted for
over 10 % of net product sales. For the six months ended June 30, 2025, E-commerce accounted for 50 % of net product sales, and no international
distributor accounted for 10 % of net product sales.
The
Company had three
distributors that accounted for 20 %, 13 %, 11 %
of accounts receivable, respectively, as of June 30, 2026. The Company had three
distributors that accounted for 32 %, 21 %
and 11 %
of accounts receivable, respectively as of December 31, 2025.
As
of June 30, 2026, the Company had three suppliers that accounted for 22 %, 20 %, and 12 % respectively, of accounts payable and accounts
payable, related party. The Company had three suppliers that accounted for 38 %, 22 %, and 10 %, respectively of accounts payable and accounts
payable, related to the party as of December 31, 2025.
NOTE
11 — RELATED PARTY TRANSACTIONS
United
Systems
In June 2021, the Company entered into a ten-year supply agreement with United Systems, the principal supplier of
its handpieces. United Systems is considered a related party because its controlling shareholder, Tom Cheng, is also a stockholder of
the Company. Under the agreement, the Company procures products pursuant to individual purchase orders and has no minimum purchase commitments. Purchases from this supplier were approximately $ 222,000 and $ 471,000 for the three and six months ended
June 30, 2026. Purchases from this supplier were approximately $ 285,000 and $ 772,000 for the three and six months ended June 30, 2025.
As of June 30, 2026, and December 31, 2025, Milestone Scientific owed this supplier approximately $ 667,000 and $ 1,100,000 , respectively,
which is included in accounts payable and accrued expenses related party on the unaudited condensed consolidated balance sheets.
Director
of Clinical Affairs
The
Company pays royalty fees to its Director of Clinical Affairs pursuant to a Technology Sale Agreement, as amended, relating to
Company products embodying technology covered by patents purchased by the Company from the Director of Clinical Affairs, including
U.S. Patent No. 7,625,354, relating to the Company’s computer-controlled local anesthetic delivery system and associated
handpiece, and U.S. Patent No. 7,618,409, relating to methods of administering an anesthetic using the system and
handpiece.
Royalty fee
attributable to the Director of Clinical Affairs was approximately $ 151,000 and $ 246,000 for the three and six months ended June
30, 2026, respectively, compared with approximately $ 119,000 and $ 232,000 for the three and six months ended June 30, 2025, respectively.
In
addition, consulting expense attributable to the Director of Clinical Affairs was approximately $ 25,000 and $ 50,000 for the three and
six months ended June 30, 2026, respectively, compared with approximately $ 39,000 and $ 78,000 for the three and six months ended June
30, 2025, respectively.
Under
such Technology Sale Agreement, as amended, the Director of Clinical Affairs is also entitled to receive stock options upon the
issuance of patents for inventions made by the Director of Clinical Affairs and purchased by the Company. Any options granted upon the achievement of such
patent-related milestones are measured and recognized as stock-based compensation expense in accordance with the applicable
accounting guidance and the terms of the related award agreement.
As
of June 30, 2026 and December 31, 2025, had recorded accrued but unpaid royalties owed to the Director of Clinical Affairs of
approximately $ 392,000
and $ 289,000 ,
respectively. These amounts are included in accounts payable—related party and accrued expenses—related party in the
Company’s consolidated balance sheets.
15
Directors
Leonard
Osser
On
April 6, 2021, Leonard Osser entered into a succession agreement with the Company and U.S. Asian Consulting Group, LLC (“U.S. Asian”),
a company of which Mr. Osser is a principal and, together with his wife, the sole members (the “Succession Agreement”).
The Succession Agreement restructured certain compensation arrangements under Mr. Osser’s July 2017 employment agreement with
the Company (the “Osser Employment Agreement”) and U.S. Asian’s July 2017 consulting agreement with the Company (the
“Osser Consulting Agreement”).
Under
the Succession Agreement, annual compensation under the Osser Employment Agreement was reduced by $ 100,000 to $ 200,000 , divided equally
between cash and equity compensation. Annual compensation under the Osser Consulting Agreement was increased by $ 100,000 to $ 200,000 ,
also divided equally between cash and equity compensation. The equity compensation component was transferred from the Osser Employment
Agreement to the Osser Consulting Agreement.
On
May 19, 2021, Mr. Osser stepped down as Interim Chief Executive Officer and assumed the role of Vice Chairman of the Board. In connection
with his appointment as Vice Chairman and his continuing consulting services, Mr. Osser was granted options to purchase 2,000,000
shares of the Company’s common stock at an exercise price equal to the fair market value of the common stock on the grant date.
The options vest over 5 five years and expire ten years from the date of grant.
Mr.
Osser resigned from the Company’s Board of Directors effective November 7, 2025.
New
Osser Agreement
On
June 19, 2026, the Company entered into a new agreement with Mr. Osser and U.S. Asian, effective as of April 1, 2026 (the “New
Osser Agreement”). The New Osser Agreement amended the Osser Employment Agreement, the Osser Consulting Agreement and the Succession
Agreement.
With
respect to periods before April 1, 2026, the New Osser Agreement provides that the Osser Consulting Agreement and the portions of the
Succession Agreement relating to the Osser Consulting Agreement were canceled and terminated. As a result, the Company has no further
obligation to make payments or provide benefits under those arrangements, whether in cash or shares.
Mr.
Osser also waived compensation and other amounts and benefits owed under the Osser Employment Agreement, subject to and conditioned
upon the Company’s:
● payment
of an aggregate of $ 64,080 of past-due amounts;
● payment
of $ 75,000 as a catch-up payment relating to the period from July 2025 through March 2026;
and
● reimbursement
of certain China-related travel and other expenses.
Shares
having a value of $ 50,000 that were earned under the prior Osser agreements on or before March 31, 2026 remain deliverable in accordance
with the applicable terms of those agreements. All shares that otherwise would have been earned for periods after March 31, 2026 were
forfeited.
Effective
April 1, 2026, under the New Osser Agreement, Mr. Osser’s position was changed to Advisor to the Chief Executive Officer.
The modified Osser Employment Agreement continues through July 17, 2027. During this period, Mr. Osser is entitled to annual
cash compensation of $ 48,000 ,
continuation of health benefits for himself and his wife, and a car allowance, subject to the limitations provided in the New Osser
Agreement.
If the Company terminates Mr. Osser’s employment without cause,
other than due to death or disability, if Mr. Osser terminates his employment for good reason, or if the Company fails to make a
required payment within 30 days after its scheduled payment date, Mr. Osser is entitled to receive any amounts accrued through the
termination or default date. He is also entitled to a lump-sum payment equal to the unpaid base salary, car allowance and healthcare payments
that otherwise would have been payable through July 10, 2027. These amounts are payable in lieu of any termination-related payments under
the prior Osser agreements.
For
the three and six months ended June 30, 2026, the Company recorded $ 14,000
and $ 64,000 of expense under the Osser Employment Agreement.
Fo r
the three and six months ended June 30, 2026, the Company recorded $ 0.00 and $ 50,000 of expense under the Osser Consulting Agreement.
For the three and six months ended June 30, 2025, the Company recorded $ 50,000 and $ 100,000 of expense under the Osser Employment Agreement.
Mr.
Osser and his wife also entered into lock-up agreements restricting the transfer of their shares of the Company’s common stock
through April 20, 2027. The lock-up agreements do not restrict the transfer of 363,339 shares for which the restrictive legends had
previously been removed.
Beneficial
Ownership
As
of June 30, 2026, Mr. Osser beneficially owned
2,844,028 shares of the Company’s common stock and is entitled to receive an additional 3,394,200 upon the termination
of his Employment and Consulting Agreement.
The
previously disclosed statement that Mr. Osser was entitled to receive an additional 3,394,200 shares upon termination of the Osser
Employment Agreement has been removed because the New Osser Agreement waived and restructured the relevant compensation obligations and
provides that shares relating to periods after March 31, 2026 were forfeited.
Dr.
D. Demesmin, Director
As
of February 2024, the University Pain Medicine Center (STEMMEE), of which Dr. D. Demesmin, a member of the Company’s Board of Directors,
serves as Chief Executive Officer, agreed to purchase products from the Company under terms and conditions consistent with those offered
to other medical pain clinics in the United States. STEMMEE purchased medical products totaling approximately $ 12,000
and $ 18,000
for each of the three and six months ended June 30, 2026. STEMMEE
purchased medical products totaling approximately $ 15,000
and $ 21,000
for each of the three and six months ended June 30, 2025. The
Company was owed approximately $ 9,600 and $ 25,500 as of June 30, 2026
and December 31, 2025, respectively. These amounts are regarded in related party accounts receivable.
16
Arjan
J. Haverhals, Director
The
Company entered into a consulting agreement with Jan Adriaan (Arjan) Haverhals (the “Haverhals Consulting Agreement”), effective
January 1, 2025. The Haverhals Consulting Agreement continues for an indefinite term unless terminated in accordance with its terms.
Either party may terminate the Haverhals Consulting Agreement upon 90 days’ prior written notice. The Company may terminate the
Haverhals Consulting Agreement upon 30 days’ prior written notice in the event of Mr. Haverhals’ inability to provide services.
Under the Haverhals Consulting Agreement, Mr. Haverhals is entitled to receive consulting fees at an annual rate of $ 350,000 , payable
monthly in arrears. For 2025, compensation was structured as follows:
●
$ 150,000 for
the first calendar quarter of 2025; and
●
$ 67,000 for
each subsequent calendar quarter of 2025.
The
Company recorded consulting expense of approximately $ 67,000 and $ 216,000 for the three and six months ended June 30, 2025 related
to the Haverhals Consulting Agreement. No expense was recorded for the three and six months ended June 30, 2026.
Mr.
Haverhals is entitled to reimbursement of reasonable expenses incurred in connection with the performance of his services. He serves
as an independent contractor and is not eligible for Company-provided employee benefits, including health or accident insurance, life
insurance, paid sick leave, or paid vacation. In connection with the Haverhals Consulting Agreement, Mr. Haverhals entered into the Company’s
standard form of non-disclosure, non-solicitation, non-competition, and invention assignment agreement.
As
of June 30, 2026, and December 31, 2025, the Company owed Mr. Haverhals approximately $ 0 and $ 89,000 , respectively, under the Haverhals
Consulting Agreement, which is included in accounts payable—related party in the Company’s condensed consolidated balance
sheets. Subsequent to December 31, 2025, Mr. Haverhals agreed to waive approximately $ 66,000 of amounts payable to him, which had previously
been included in accounts payable—related party.
Pursuant
to the Haverhals Consulting Agreement, Mr. Haverhals is entitled to receive 895,013 shares of the Company’s common stock six months
following his resignation as Chief Executive Officer, subject to the terms of the Haverhals Consulting Agreement. As of June 30, 2026,
such shares had not been issued.
At
the Company’s Annual Meeting of Stockholders held on December 18, 2025, Mr. Haverhals was not re-elected to the Board of Directors,
and his term as a director expired at the conclusion of the Annual Meeting.
April
2025 Convertible Notes
On
April 9, 2025, the Company issued a series of promissory notes in the aggregate amount of $ 800,000 to Mr. Neal Goldman, Ms. Benedetta
Casamento, and Dr. Didier Demesmin, each of whom is a director of the Company. The notes are due April 9, 2028 and bear interest at the
annual rate of prime less 2.50 %, payable annually. All principal and interest shall be payable in cash and/or shares of common stock
at the sole discretion of the Company. The notes are convertible into shares of common stock by the holder at any time and by the Company
at maturity. If the Company sells equity securities for gross proceeds in excess of $ 4,000,000 , the holders may request repayment of
their note in either cash, shares of common stock or a combination of cash and shares; provided, that the holders would then be entitled
to receive only so much cash as the net proceeds to the Company in such sale of equity securities, after payment of other indebtedness
and other uses (other than working capital) specified as a use of the proceeds in the relevant offering or disclosure documentation,
shall be in excess of $ 4,000,000 . Upon a liquidation event of the Company, as defined in the notes which includes a sale of the Company
or assets, a merger, reorganization or combination transaction where the shareholders before the transaction own less than 50 % of the
Company after the transaction and a liquidation, dissolution or winding-up of the Company, the notes will be repaid in cash or its portion
of any non-cash consideration. The conversion rate for any issuance of shares of common stock will be at the then fair value of a share
of common stock, with the fair value being determined with reference to the public market price of a share of common stock, but not less
than $ 0.50 . The notes are unsecured and have typical default terms.
On
April 20, 2026, the Company completed the Private Placement of 7,962,963
units at a purchase price of $ 0.27
per unit, generating gross proceeds of approximately $ 2.15
million, consisting of $ 1.80
million in cash and a reduction of $ 351,000
in outstanding principal of the Company’s Convertible
Notes, the holders of which applied such principal amounts toward the purchase of units in the offering in lieu of cash. Each of Mr.
Neal Goldman, Ms. Benedetta Casamento and Dr. Didier Demesmin reduced their outstanding aggregate principal amount of Convertible Notes
by $ 219,375 ,
$ 87,750
and $ 43,875 ,
respectively and received 812,501 ,
325,000
and 162,500
shares and warrants, respectively.
On
July 24, 2026, the Company received notices of conversion (the “Conversion Notices”) from Benedetta Casamento, Dr. Didier
Demesmin and Neal Goldman, each of whom is a director of the Company (collectively, the “Holders”), with respect to the Company’s
amended and restated Convertible Notes. The Conversion Notices constitute the Holders’ elections, pursuant to Section 5(a) of the
Convertible Bridge Notes, to convert the remaining outstanding principal amount and accrued interest under their respective Convertible
Notes into shares of the Company’s common stock, effective automatically at such time as the Fair Value (as defined in the Convertible
Notes) of the common stock is not less than $ 0.50 per share and the applicable Holder is permitted to buy and sell securities of the
Company in compliance with the Company’s Insider Trading Policy.
17
BP4
S.r.l. / Innovest S.p.A.
BP4
S.r.l. / Innovest S.p.A.\n\nBP4 S.r.l. (“BP4”) is a significant shareholder of the Company, beneficially owning approximately
11.31 % of the Company’s outstanding common stock, and is considered a related party. On January 15, 2026, the Company entered into
an Amended and Restated Memorandum of Understanding (the “MOU”) with Innovest S.p.A., as the holder of certain consent and
blockage rights with respect to BP4. Pursuant to the MOU, and subject to certain conditions, BP4 agreed to enter into a lock-up agreement
pursuant to which it would not distribute or sell any of its shares of capital stock of the Company for twelve months following consummation
of a $2.5 million offering by the Company. The lock-up provides for early release if the Company’s stock price exceeds specified
thresholds for a defined period, permitting partial distributions of shares to BP4’s quotaholders. The Company paid BP4 $60,000
in respect of additional disbursements accumulated in connection with the transaction contemplated by the MOU, which payments are subject
to an aggregate cap of $100,000.
On
March 31, 2026, the Company entered into an amendment to the MOU to, among other things, revise the definition of “Qualified Offering” in order to facilitate an offering by the Company, and required certain additional persons and entities to enter into lock-up
agreement. The Private Placement on April 20, 2026 satisfied the requirement of a “Qualified Offering” and the required additional
persons and entities signed lock-up agreements.
Bendetta
Casamento-Executive Chairman.
On June 24, 2026, the Board, with Benedetta Casamento not in attendance, determined, in view of
the increased role played, and to continue to be played, by Ms. Casamento in the business and affairs of the Company, to approve the recommendation
of the Compensation Committee, electing Ms. Casamento as Executive Chairman. Prior to becoming Executive Chairman, Ms. Casamento has been
the Chairman of the Board of the Company as an independent director, devoting substantial time and effort to the Company. As Executive
Chairman, she is expected to enhance executive leadership, strategic oversight, investor engagement, and corporate development support
for the Company. Her duties and responsibilities as Executive Chairman include, without limitation, working collaboratively with the Chief
Executive Officer and senior management to establish and execute the Company’s strategic objectives, supporting corporate development
initiatives, including strategic partnerships, acquisitions, licensing opportunities, and commercial growth initiatives, assisting with
investor relations activities, capital markets initiatives, financing transactions, and communications with current and prospective investors,
and advising management on operational, financial, regulatory, and governance matters affecting the Company. For her services as Executive
Chairman, the Company has agreed to pay her, (1) a salary at the rate of $75,000 per year as supplemental cash compensation, (2) 115.385%
of the amount per year she would receive each year she is Executive Chairman if she remained an independent director and for being the
chair and member of the committees she was chair and a member for such period (the “Director Equivalent”), in equity awards,
in lieu of the equity she had previously been receiving as compensation in respect of such Board and committee service, and otherwise
with the same vesting and other terms as awards of equity to directors for such Board and committee service, and (3) a one-time grant
of $100,000 of shares of restricted common stock of the Company vesting on July 1, 2026. For the current year, the amount referred to
in clause (1) above shall be $75,000, based on the Director Equivalent of $65,000. As Executive Chairman, Ms. Casamento would also be
entitled to participate in the employee benefit plans and programs of the Company in which other senior executives of the Company participate,
subject to eligibility requirements, enrollment criteria, and the other terms and conditions of such plans and programs. Ms. Casamento
is no longer considered an independent director, and she resigned from the committees on which she served.
On June 24, 2026, Ms. Casamento
and the Company entered into an employment letter agreement with respect to her status as Executive Chairman. The foregoing description
of the material terms of such letter agreement does not purport to be complete and is qualified in its entirety by reference to such agreement, a copy of which, previously filed with the Company’s Form 8-K, is an as Exhibit hereto.
NOTE
12 — COMMITMENTS
(1)
Contract Manufacturing Agreement
Milestone
Scientific has informal arrangements with third-party manufacturers of the STA devices and epidural instruments pursuant to which they
manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. The Company
has a purchase commitment for the delivery of 1,650
STA instruments as of June 30, 2026. As of June 30, 2026 and
December 31, 2025, the purchase order commitment was approximately 871,000
respectively, and approximately $ 1.4
million was paid and reported in advance on contracts in the
unaudited condensed consolidated balance sheet. The Company also had advances on contracts of approximately $ 364,000 related to
materials for future purchase orders for the manufacture of its next-generation dental instrument.
The
advances in contracts represent funding for future epidural instruments and epidural replacement parts. As of June 30, 2026 and December
31, 2025, the Company also has advances on an open purchase order for long lead items for a future purchase order for the manufacturing
of Epidural instruments of approximately $ 34,000 , respectively.
(2)
Operating Leases
The
Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease
liabilities:
●
As
the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the
present value of the lease payments. The Company has utilized its incremental borrowing rate based on the long-term borrowing costs
of comparable companies in the Medical Device industry.
●
Since
the Company elected to account for each lease component and its associated non-lease components as a single combined lease component,
all contract consideration was allocated to the combined lease component.
●
The
expected lease terms include non-cancellable lease periods. Renewal option periods are not included in the determination of the lease
terms as they were not reasonably certain to be exercised.
The
components of lease expense were as follows:
SCHEDULE OF COMPONENTS OF LEASE EXPENSE
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Three months ended
Six months ended
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Cash paid for operating lease liabilities
$ 31,882
$ 31,882
$ 31,882
$ 63,764
Cash paid for finance lease liabilities
3,417
3,417
3,417
6,834
Weighted Average Remaining Lease Term
Finance leases (years)
3.27 years
4.50 years
Operating leases (years)
0.75 years
1.75 years
Weighted-average discount rate – operating leases
9.20 %
9.20 %
Weighted-average discount rate – finance leases
9.20 %
9.20 %
NOTE
13 — SUBSEQUENT EVENT
On
July 27, 2026, the Company held its 2026 Annual Meeting of Stockholders. At the Annual Meeting, the Company’s stockholders:
● Elected
Benedetta Casamento, Neal Goldman, Eric Hines, Dr. Didier Demesmin and Dr. Dawood Sayed to
serve as directors until the Company’s 2027 Annual Meeting of Stockholders or until
their respective successors are duly elected and qualified;
● Approved
an amendment to the Company’s Restated Certificate of Incorporation to increase the
number of authorized shares of common stock from 125,000,000 to 135,000,000 ;
● Approved
an amendment to the Company’s Amended and Restated 2020 Equity Incentive Plan to increase
the number of shares of common stock reserved and available for issuance under the plan from
11,500,000 to 28,750,000 ;
● Approved,
on a non-binding advisory basis, the compensation of the Company’s named executive
officers; and
● Ratified
the appointment of Grassi & Co., CPAs, P.C. as the Company’s
independent registered public accounting firm for the fiscal year ending December 31, 2026.
On
July 29, 2026, the Board of Directors:
● Re-elected
each of Kelly Ulto and Greg Shilling to serve as a director of the Company, effective July
27, 2026, until the Company’s 2027 annual meeting of stockholders (the “2027
Annual Meeting”) or until their respective successor is duly elected and qualified,
or such director’s earlier resignation or removal
● Reaffirmed
its determination that each of Ms. Ulto and Mr. Shilling is independent under the applicable
NYSE American listing standards;
● Reaffirmed
its determination that Ms. Ulto qualifies as an “audit committee financial expert,”
as defined in Item 407(d)(5) of Regulation S-K as well as Rule 10A-3 under the Securities
Exchange Act of 1934, as applicable;
● Appointed
Ms. Ulto as Chair of the Audit Committee and as a member of the Compensation Committee and
the Nominating and Corporate Governance Committee; and
● Appointed
Mr. Shilling as Chair of the Compensation Committee and as a member of the Audit Committee
and the Nominating and Corporate Governance Committee.
These
events occurred subsequent to June 30, 2026 and did not require adjustment to the Company’s unaudited condensed consolidated financial
statements.
18
ITEM
2. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated
financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q, as well as our Annual Report on
Form 10-K for the year ended December 31, 2025.
This
discussion contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those
anticipated in these forward-looking statements.
OVERVIEW
Milestone
Scientific Inc. is a biomedical technology company that designs, develops, patents, and commercializes innovative diagnostic and therapeutic
injection technologies for medical and dental applications. The Company’s common stock trades on the NYSE American under the symbol
“MLSS.”
The
Company’s proprietary Dynamic Pressure Sensing Technology® (DPS) platform is a computer-controlled system designed to improve
the precision, efficiency, and patient comfort of injections by regulating flow rate and monitoring pressure at the needle tip in real
time.
The
Company operates in two reportable segments:
●
Dental ,
which represents the Company’s primary source of revenue and is driven by sales of instruments and recurring handpiece consumables;
and
●
Medical ,
which represents a strategic growth area focused on the commercialization of the CompuFlo® Epidural System.
The
Company continues to focus on expanding adoption of its DPS technology platform, advancing commercialization of its Medical segment,
and maintaining disciplined cost management while supporting targeted growth initiatives.
The
following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business
segment, product category:
Three Months Ended June 30, 2026
Three Months Ended June 30, 2025
Dental
Medical
Grand Total
Dental
Medical
Grand Total
Domestic-US
Instruments
$ 183,290
$ -
$ 183,290
$ 183,190
$ 2,000
$ 185,190
Handpieces
$ 1,047,625
$ 104,400
$ 1,152,025
1,085,047
30,100
1,115,147
Other
$ 22,122
$ -
$ 22,122
10,029
-
10,029
Grand Total
$ 1,253,037
$ 104,400
$ 1,357,437
$ 1,278,266
$ 32,100
$ 1,310,366
International Rest of World
Instruments
$ 252,458
$ -
$ 252,458
$ 269,871
$ -
$ 269,871
Handpieces
$ 723,184
$ 2,000
$ 725,184
732,218
-
732,218
Other
$ 7,739
$ -
$ 7,739
11,011
-
11,011
Grand Total
$ 983,381
$ 2,000
$ 985,381
$ 1,013,100
$ -
$ 1,013,100
International China
Instruments
$ 294,000
$ -
$ 294,000
$ -
$ -
$ -
Handpieces
204,220
-
204,220
-
-
-
Other
-
-
-
-
-
-
Grand Total
$ 498,220
$ -
$ 498,220
$ -
$ -
$ -
Total Product Sales
$ 2,734,638
$ 106,400
$ 2,841,038
$ 2,291,366
$ 32,100
$ 2,323,466
19
Six Months Ended June 30, 2026
Six Months Ended June 30, 2025
Dental
Medical
Grand Total
Dental
Medical
Grand Total
Domestic-US
Instruments
$ 344,922
$ 28,300
$ 373,222
$ 361,065
$ 5,000
$ 366,065
Handpieces
2,064,989
179,600
2,100,894
2,100,894
74,350
2,175,244
Other
44,084
-
44,084
24,389
-
24,389
Grand Total
$ 2,453,995
$ 207,900
$ 2,661,895
$ 2,486,348
$ 79,350
$ 2,565,698
International Rest of World
Instruments
$ 499,553
$ 4,100
$ 503,653
$ 344,814
$ 4,000
$ 348,814
Handpieces
1,305,669
2,000
1,307,669
1,508,065
-
1,508,0657
Other
31,634
-
31,634
23,309
-
23,309
Grand Total
$ 1,836,856
$ 6,100
$ 1,842,956
$ 1,876,188
$ 4,000
$ 1,880,188
International China
Instruments
$ 294,000
$ -
$ 294,000
$ 110,000
$ -
$ 110,000
Handpieces
204,220
-
204,220
-
-
-
Other
-
-
-
-
-
-
Grand Total
$ 498,220
$ -
$ 498,220
$ 110,000
$ -
$ 110,000
Total Product Sales
$ 4,789,071
$ 214,000
$ 5,003,071
$ 4,472,536
$ 83,350
$ 4,555,886
Current
Product Platform
See
Note 1, “Organization and Business”.
Results
of Operations
The
following table sets forth the consolidated results of operations for the three months ended June 30, 2026 and 2025, respectively. The
trends suggested by this table may not be indicative of future operating results:
Three Months Ended
June
30, 2026
Three Months Ended
June
30, 2025
Six Months Ended
June
30, 2026
Six Months Ended
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 )
20
Three
months ended June 30, 2026 compared to three months ended June 3, 2025
Net
sales for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 2,734,638
$ 2,291,366
$ 443,272
Medical
106,400
32,100
74,300
Total sales, net
$ 2,841,038
$ 2,323,466
$ 517,572
Total
product sales for the three months ended June 30, 2026 were approximately $2.8 million, compared to approximately $2.3 million for the
same period in 2025, representing an increase of approximately $518,000, or 22.3%.
Dental product revenue was approximately $2.7 million, an increase of approximately $443,000, or 19.3%, compared
with the prior-year period. The increase was primarily driven by approximately $498,000 of sales to customers in China during the current
quarter, compared with no sales to China in the prior-year period. This increase was partially offset by modest decreases in sales in
the United States and other international markets of approximately 2% and 3%, respectively, which may reflect normal fluctuations in distributor
ordering patterns and broader market conditions.
Medical
revenue increased to approximately $106,000, compared to approximately $32,000 in the prior period, representing an increase of approximately $74,000, or 231.5%. The increase reflects continued early-stage adoption and commercialization of the Company’s
medical products.
Overall,
the increase in total net sales was driven by growth in both the Dental and Medical segments, notwithstanding continued variability in
certain international markets.
Gross
profits for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 1,828,605
$ 1,586,500
$ 242,105
Medical
81,562
31,106
50,456
Total gross profit
$ 1,910,167
$ 1,617,606
$ 292,561
Gross margin was approximately 67.2% for the three
months ended June 30, 2026, compared with approximately 69.6% for the same period in 2025.
Gross profit increased by approximately $293,000,
or 18.1%, primarily due to higher sales in both the Dental and Medical segments. Dental gross profit increased by approximately $242,000,
while Medical gross profit increased by approximately $50,000.
Gross margin decreased by approximately
2.4 percentage points, primarily due to product and customer mix and increased product costs, including tariffs imposed on certain imported
products and components. These cost pressures were partially offset by the higher level of sales during the current period.
21
Selling,
general and administrative expenses for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 1,024,724
$ 1,083,794
$ (59,070 )
Medical
412,894
449,551
(36,657 )
Corporate
1,507,914
1,497,607
(10,307 )
Total selling, general and administrative expense
$ 2,945,532
$ 3,030,952
$ (85,420 )
Total
operating expenses decreased by approximately $0.1 million, or 4.2%, to approximately $3.0 million for the three months ended June 30,
2026, compared with approximately $3.1 million for the three months ended June 30, 2025. The decrease was primarily attributable to lower
quality and regulatory expenses, consulting and professional service fees, research and development expenses, rent and occupancy costs,
and other segment items. These decreases were partially offset by increases in stock-based compensation, warehousing expense, royalty
expense, marketing expense, salaries and employee benefits, and travel expense. increased promotional activities, trade shows, advertising,
product launches, or customer-acquisition initiatives. Salaries and employee benefits increased by approximately $23,000, or 2.8%, to
approximately $863,000, compared with approximately $840,000 in the prior-year period. The increase was primarily attributable to salary
increases, changes in staffing levels, employee benefits, or other personnel-related costs. Stock-based compensation expense increased
by approximately $94,000, or 59.1%, to approximately $254,000, compared with approximately $160,000 in the prior-year period. The increase
was primarily attributable to new equity awards, the timing of vesting, or changes in the valuation and forfeiture of outstanding awards.
Royalty expense increased by approximately $31,000, or 25.9%, to approximately $151,000, compared with approximately $120,000 in the
prior-year period. The increase was primarily attributable to higher sales of products subject to contractual royalty arrangements. Warehousing
expense increased by approximately $46,000, or 36.1%, to approximately $175,000, compared with approximately $129,000 in the prior-year
period. The increase was primarily attributable to higher inventory storage, handling, fulfillment, freight, or third-party logistics
costs. Quality and regulatory expense decreased by approximately $203,000, or 60.9%, to approximately $130,000, compared with approximately
$333,000 in the prior-year period. The decrease was primarily attributable to lower spending on regulatory submissions, product testing,
quality-system initiatives, compliance consulting, or other regulatory activities. Marketing expense increased by approximately $30,000,
or 39.2%, to approximately $108,000, compared with approximately $77,000 in the prior-year period. The increase was primarily attributable
to increased promotional activities, trade shows, advertising, product launches, or customer-acquisition initiatives. Consulting and
professional service fees decreased by approximately $83,000, or 9.3%, to approximately $817,000, compared with approximately $901,000
in the prior-year period. The decrease was primarily attributable to lower legal, accounting, advisory, consulting, or transaction-related
expenses. Travel expense increased by approximately $13,000, or 17.9%, to approximately $87,000, compared with approximately $74,000
in the prior-year period. The increase was primarily attributable to higher travel associated with sales, regulatory, operational, and
business-development activities.
Research
and Development for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 6,609
$ 47,089
$ (40,480 )
Medical
-
4,700
(4,700 )
Corporate
-
-
-
Total research and development
$ 6,609
$ 51,789
$ (45,180 )
Research
and development expense decreased by approximately $45,000, as no major R&D expenses were incurred during the current period
compared to the prior period. The Company continues to evaluate its research and development priorities and may make targeted
investments in future periods to support product enhancements, new applications, and long-term growth initiatives.
Profit
(Loss) from Operations for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 797,273
$ 455,626
$ 341,647
Medical
(331,332 )
(423,152 )
91,820
Corporate
(1,527,504 )
(1,517,105 )
(10,399 )
Total loss from operations
$ (1,061,563 )
$ (1,484,631 )
$ 423,068
Loss from operations was approximately $1.1 million for the three months ended June 30, 2026. The loss from operations
resulted from gross margin of approximately $1.9 million, which was more than offset by operating expenses of approximately $3.0 million.
The
improvement was primarily attributable to reduced operating expenses.
Six
months ended June 30, 2026 compared to six months ended June 30, 2025
Net
sales for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 4,789,071
$ 4,472,536
$ 316,535
Medical
214,000
83,350
130,650
Total sales, net
$ 5,003,071
$ 4,555,886
$ 447,185
Total
product sales for the six months ended June 30, 2026 were approximately $5.0 million, compared to approximately $4.6 million for the
same period in 2025, representing an increase of approximately $447,000, or 9.8%.
Dental
product revenue was approximately $4.8 million, representing an increase of approximately $317,000, or 7.1%, compared to the prior
year end period. The increase was primarily attributable to higher sales of the Company’s dental products. The increase was primarily driven by approximately $498,000 of sales to customers in China during the current quarter,
compared with $110,000 sales to China in the prior-year period. This increase was partially offset by
lower demand from certain international distributors, which the Company believes was influenced by ongoing geopolitical conditions, including
the Russia-Ukraine conflict and instability in the Middle East.
22
Medical product revenue increased to approximately $214,000 from approximately $83,000 in the prior-year period, representing an increase
of approximately $131,000, or 156.7%. The increase reflects continued early-stage adoption and commercialization of the Company’s
medical products.
Overall,
the increase in total net sales was driven by growth in both the Dental and Medical segments, notwithstanding continued variability in
certain international markets.
Gross
profits for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 3,298,457
$ 3,182,775
$ 115,682
Medical
175,734
82,266
93,468
Total gross profit
$ 3,474,191
$ 3,265,041
$ 209,150
Gross
margin was approximately 69.4% for the six months ended June 30, 2026, compared with approximately 71.7% for the same period in 2025.
Gross profit increased by approximately
$209,000, or 6.4%, primarily due to higher sales in both the Dental and Medical segments. Dental gross profit increased by approximately
$116,000, while Medical gross profit increased by approximately $93,000.
Gross margin decreased by approximately
2.2 percentage points, primarily due to product and customer mix and increased product costs, including tariffs imposed on certain imported
products and components. These cost pressures were partially offset by the higher level of sales and increased contribution from the
Medical segment during the current-year period.
Selling,
general and administrative expenses for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 1,958,740
$ 2,135,900
$ (177,160 )
Medical
820,108
917,655
(97,547 )
Corporate
2,539,336
3,234,125
(694,789 )
Total selling, general and administrative expense
$ 5,318,184
$ 6,287,680
$ 969,496
Total operating expenses decreased by
approximately $1.4 million, or 20.5%, to approximately $5.4 million for the six months ended June 30, 2026, compared with
approximately $6.7 million for the six months ended June 30, 2025. The decrease was primarily attributable to lower consulting and
professional service fees, research and development expenses, and quality and regulatory expenses, partially offset by increases in
salaries and employee benefits, stock-based compensation expense, warehousing expense, royalty expense, and travel expense. Salaries
and employee benefits increased by approximately $84,000, or 5.2%, to approximately $1.7 million, compared with approximately $1.6
million in the prior-year period. The increase was primarily attributable to additional personnel, salary increases, employee
benefits, or changes in departmental staffing Stock-based compensation expense increased by approximately $76,000, or 15.5%, to
approximately $566,000, compared with approximately $490,000. Royalty expense increased by approximately $14,000, or 6.1%, to
approximately $246,000, compared with approximately $232,000 in the prior-year period. The increase was primarily attributable to
higher sales of products subject to royalty arrangements. Warehousing expense increased by approximately $54,000, or 21.5%, to
approximately $305,000, compared with approximately $251,000 in the prior-year period. The increase was primarily attributable to
higher inventory storage, handling, fulfillment, freight, or third-party logistics costs. Quality and regulatory expense decreased
by approximately $192,000, or 46.1%, to approximately $225,000, compared with approximately $417,000 in the prior-year period. The
decrease was primarily attributable to lower spending on regulatory submissions, product testing, quality-system initiatives,
compliance consulting, or other regulatory activities. Marketing expense decreased by approximately $8,000, or 4.1%, to
approximately $181,000, compared with approximately $189,000 in the prior-year period. The decrease was primarily attributable to
the timing of promotional programs, trade shows, advertising, or customer-acquisition activities. Consulting and professional
service fees decreased by approximately $976,000, or 44.7%, to approximately $1.2 million, compared with approximately $2.2 million
in the prior-year period. The decrease was primarily attributable to lower legal, accounting, advisory, consulting, and
transaction-related costs incurred during the current period.
23
Research
and Development for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 6,609
$ 411,896
$ (405,287 )
Medical
-
9,013
(9,013 )
Corporate
-
-
-
Total research and development
$ 6,609
$ 420,909
$ (414,300 )
Research
and development expense decreased by approximately $414,000, as no major R&D expenses were incurred during the current period compared
to the prior period.
The
Company continues to evaluate its research and development priorities and may make targeted investments in future periods to support
product enhancements, new applications, and long-term growth initiatives.
Profit
(Loss) from Operations for 2026 and 2025 were as follows:
2026
2025
Change
Dental
$ 1,333,108
$ 634,979
$ 698,129
Medical
(644,375 )
(844,402 )
200,027
Corporate
(2,578,378 )
(3,273,061 )
694,683
Total loss from operations
$ (1,889,645 )
$ (3,482,484 )
$ 1,592,839
Loss from operations for the six months ended June
30, 2026 was approximately $1.8 million, compared with approximately $3.5 million for the six months ended June 30, 2025, an improvement
of approximately $1.7 million, or 48.6%.
The improvement was primarily attributable to higher
revenue and gross profit and significant reductions in professional fees, research and development expenses, quality control and regulatory
expenses. These improvements were partially offset by increases in salaries and compensation, warehousing and logistics expenses, royalty
expense and travel expenses.
Liquidity
and Capital Resources
Cash
Flows
The
following table summarizes our sources and uses of cash for the six months ended:
2026
2025
Change
Cash
flow:
Net
cash used in operating activities
(498,285 )
$ (2,772,273 )
$ 2,273,988
Net
cash used in investing activities
(5,771 )
(5,776 )
5
Net
cash provided by financing activities
1,458,184
794,305
663,879
$ 954,128
$ (1,983,744 )
$ 2,937,872
Net cash used in operating activities was approximately $0.5 million for
the six months ended June 30, 2026, compared with approximately $2.8 million for the six months ended June 30, 2025. The approximately
$2.3 million decrease in cash used in operating activities was primarily attributable to a reduction in net loss and favorable changes
in certain working capital account
Net
cash used in investing was minimal in both periods.
Net cash provided by financing
activities was approximately $1.5 million for the six months ended June 30, 2026, compared with approximately $0.8 million for the
six months ended June 30, 2025. During the six months ended June 30, 2026, the Company received approximately $1.8 million of gross
proceeds (or approximately $1.5 million net of issuance costs) from a private placement. Additionally, approximately $350,000 of
convertible notes payable was converted into shares of the Company’s common stock in a noncash financing transaction.
Consideration
of the Company ’ s ability to continue as a going concern.
As
of June 30, 2026, the Company had cash and cash equivalents of approximately $2.1 million and working capital of approximately $3.7 million.
The
Company has incurred recurring operating losses and has an accumulated deficit. 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 at a purchase price of $0.27 per unit, generating gross
proceeds of approximately $2.15 million, consisting of $1.80 million in cash and a reduction of $351,000 in outstanding principal 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
Company’s ability to continue as a going concern is dependent upon its ability to generate sufficient revenue, manage operating
expenses, and obtain additional financing, if necessary.
As discussed in Note 2 to the unaudited condensed consolidated financial
statements, the Company’s current financial condition raises substantial doubt about its ability to continue as a going concern.
Management believes that existing cash resources, anticipated collections and potential financing proceeds may support near-term operations;
however, additional financing is required, and there can be no assurance that such financing will be available on acceptable terms, or
at all. Accordingly, substantial doubt about the Company’s ability to continue as a going concern has not been alleviated.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Milestone
Scientific is a “smaller reporting company” as defined by Regulation S-K and, as such, is not required to provide the information
required by this item.
24
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Principal Accounting Officer, evaluated the effectiveness of our
disclosure controls and procedures as of June 30, 2026. The term “disclosure controls and procedures,” as defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or Exchange Act, means controls and other procedures of
a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and
forms.
Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management,
including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow
timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed to do, and management
necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such an evaluation,
our Chief Executive Officer and Principal Accounting Officer concluded that, as of June 30, 2026, our disclosure controls and procedures
were effective at a reasonable assurance level.
Changes
in Internal Control over Financial Reporting
We
routinely review our internal control over financial reporting and, from time to time, make changes intended to enhance the effectiveness
of our internal control over financial reporting. During the three months ended June 30, 2026, we made no changes to our internal control
over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, that we believe materially
affected, or are reasonably likely to affect, our internal control over financial reporting materially.
Item
1 – Legal Proceedings
None
Item
1A. Risk Factors
Except
as disclosed below, there have been no material changes to the risk factors previously disclosed in Part I, Item 1A, of our 2025 Annual
Report.
Our
ability to continue as a going concern may adversely affect our business
The
Company has incurred significant losses since its inception and continues to experience operating losses. Although operating performance
improved during the six months ended June 30, 2026, including positive operating cash flow, there can be no assurance that the Company
will sustain profitability or positive cash flows in future periods. As of June 30, 2026, the Company had limited cash resources, and
these conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company may need to raise
additional capital through equity or debt financings, and such financing may not be available on acceptable terms, or at all.
We
are dependent on our dental product line for the majority of our revenue
A
significant portion of the Company’s revenue is derived from its dental products, particularly the STA Single Tooth Anesthesia
System® and related handpieces. Any decline in demand, increased competition, pricing pressures, or disruption in distribution channels
for these products could have a material adverse effect on the Company’s financial condition and results of operations.
25
Our
medical product commercialization efforts may not achieve the expected adoption
The
Company is in the process of expanding the commercialization of its medical products, including the CompuFlo® Epidural Computer Controlled
Anesthesia System. While the Company has obtained 510(k) clearance from the FDA, CE mark approval for European markets, and a Category
III CPT code to support reimbursement submissions, adoption by healthcare providers may take longer than expected and the Company has
maintained a material allowance against slow-moving Medical finished goods inventory as a result. Factors such as continued reimbursement
uncertainty, clinician adoption rates, competition, and sales execution capacity may further limit the Company’s ability to generate
meaningful revenue from its medical segment, and there can be no assurance that the Company’s investment in medical inventory and
commercialization efforts will be recovered.
Changes
to United States tariff and import/export regulations may have a material adverse effect on our business, financial condition and results
of operations.
The
United States has recently enacted and proposed to enact significant new tariffs, and President Trump has directed various federal agencies
to evaluate key aspects of U.S. trade policy further. There have been and are ongoing discussions and commentaries regarding potential
significant changes to U.S. trade policies, treaties and tariffs. There exists significant uncertainty about the future relationship
between the U.S. and other countries with respect to such trade policies, treaties and tariffs. These developments, or the perception
that any of them could occur, may have a material adverse effect on global economic conditions and the stability of global financial
markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the U.S. We source important
elements used in our products from China. We have significant sales in jurisdictions outside the United States. Any of these factors
could depress economic activity and restrict our access to suppliers or customers and have a material adverse effect on our business,
financial condition and results of operations.
Government
Action on tariffs, research grants, and other funding may impede our ability to conduct our research and to raise capital.
Federal
government actions to impose tariffs and limit research grants and other funding, including funding for universities and research enterprises,
may cause disruption to our business. To the extent the Company seeks to invest in product enhancements or next-generation development,
including further advancement of the CompuFlo® Epidural platform, government actions that constrain collaborative research funding
may reduce the pool of available research partners and increase the cost and difficulty of such efforts. In addition, tariffs are likely
to increase the cost of doing business, particularly given the Company’s reliance on Chinese manufacturers for handpieces and other
key components, and reduced research funding may make it more difficult for the Company to attract capital from investors who consider
the availability of funded development partners as part of their investment analysis.
We
are subject to risks related to international operations and geopolitical conditions
The
Company generates a meaningful portion of its revenue from international markets through a global distribution network spanning more
than 30 countries. International operations are subject to risks including economic instability, regulatory changes, supply chain disruptions,
and geopolitical events. For example, ongoing geopolitical tensions, including conflicts in Eastern Europe and the Middle East, have
disrupted certain markets served by the Company’s international distributors and may adversely impact demand, distribution, and
revenue in affected regions. Continued or escalating geopolitical instability could further negatively impact the Company’s international
sales.
Our
business is subject to significant risks arising from our dual exposure to China as both a manufacturing source and a sales market.
26
The
Company relies on Chinese third-party manufacturers for a substantial portion of its products and also previously generated revenue from
Chinese distributors. During the three months ended June 30, 2026, revenue from China increased to $498,000, compared to $0 in the prior
period. Simultaneously, escalating U.S.-China trade tensions and newly imposed tariffs have increased the cost of sourcing products and
components from China. This dual exposure - reduced revenue from Chinese customers and increased costs from Chinese suppliers - may materially
and adversely affect our results of operations. Furthermore, regulatory actions by either the U.S. or Chinese government, including export
controls, retaliatory trade measures, restrictions on technology transfer, or sanctions, could further disrupt our supply chain or eliminate
our ability to sell into the Chinese market entirely. Any such developments could have a material adverse effect on our business, financial
condition, and results of operations.
O ur
operating results may fluctuate due to changes in product mix and demand
The
Company’s results of operations may fluctuate from period to period due to changes in product mix, including variations between
instrument and handpiece sales, as well as geographic demand. Shifts in product mix, pricing, or customer purchasing patterns may impact
on gross margins and overall profitability.
We
rely on key personnel and consultants
The
Company’s success depends in part on the continued services of key executives, consultants, and technical personnel. The loss of
key individuals or the inability to attract and retain qualified personnel could adversely affect the Company’s ability to execute
its business strategy, maintain key relationships, and advance its commercialization efforts.
Our
common stock may be delisted from NYSE American if we fail to regain compliance with continued listing standards by April 8, 2027.
Our common stock is listed on NYSE American under
the symbol “MLSS.” On October 8, 2025, the Company received a written notice from NYSE American stating that it is not in
compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide,
which require minimum stockholders’ equity of $4 million and $6 million, respectively, for companies with sustained operating losses.
As of June 30, 2026, the Company’s reported total stockholders’ equity was approximately $3.5 million - below both thresholds
- and the Company has reported net losses in each of the past five fiscal years.
To maintain its listing, the Company submitted a plan
of compliance outlining the actions it has taken or will take to regain compliance. The Company will be able to continue its listing but
will be subject to periodic reviews by the NYSE American. If the Company fails to comply with the continued listing standards by April
8, 2027, or if the Company does not make progress consistent with the plan, the NYSE American will initiate delisting procedures as appropriate.
The Company’s management is pursuing options to address the deficiency.
While in the Private Placement, we increased our stockholders’
equity, the Company cannot assure that it will achieve the required equity thresholds within the required timeframe, particularly given
its ongoing operating losses and going concern uncertainty. If we fail to regain compliance with and adhere to NYSE American’s strict
listing criteria, including with respect to stock price, our market capitalization and stockholders’ equity, our stock may be de-listed.
This would impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which
may be depressed by the relative illiquidity, but also through delays in the timing of transactions and the potential reduction in media
coverage. As a result, an investor might find it more difficult to dispose of our common stock if we are delisted. Any failure at any
time to meet the continuing NYSE American listing requirements would have an adverse impact on the value of and trading activity in our
common stock. There can be no assurance that we can maintain the listing of our common stock on the NYSE American.
Our
April 2026 private placement and outstanding convertible instruments create significant dilution risk for existing stockholders.
In
April 2026, the Company issued 7,962,963 units in a private placement at $0.27 per unit, each consisting of one share of common stock
and one warrant to purchase one share of common stock at an exercise price of $0.3375, exercisable for three years. This issuance increased
the Company’s outstanding shares by approximately 10%. If all warrants are exercised, existing stockholders would experience an
additional approximately 10% dilution, generating up to approximately $2.69 million in gross proceeds. In addition, following the partial
conversion of $351,000 of principal in connection with the private placement, the Company has approximately $449,000 in aggregate outstanding
principal under its Convertible Notes, which are convertible into shares of common stock at the option of the holders or the Company
at a conversion price not less than $0.50 per share. Given the Company’s recurring operating losses and going concern uncertainty,
we may need to pursue additional equity or debt financings in the future, which would further dilute existing stockholders. Cumulative
dilution from these instruments and any future financings may depress the trading price of our common stock and adversely affect stockholder
value.
27
Item
2. Unregistered Sales of Equity Securities and use of proceeds
Not
applicable.
Item
3. Default upon Senior Securities
Not
applicable.
Item
4. Mine Safety Disclosure
Not
applicable.
Item
5. Other Information
Not
applicable.
Item
6. Exhibits and Financial Statement Schedules
Exhibit
No
Description
3.1
Restated Certificate of Incorporation of Milestone, as amended as of August 5, 2026
4.1
Form of Warrant (incorporated by reference to Exhibit 4.1 to the Form 8-K filed April 21, 2026)
10.1
Form of Securities Purchase Agreement, dated April 20, 2026 (incorporated by reference to Exhibit 10.1 to the Form 8-K filed April 21, 2026)
10.2
Form of Registration Rights Agreement, dated April 20, 2026 (incorporated by reference to Exhibit 10.2 to the Form 8-K filed April 21, 2026)
10.3
Form of Lock-up Agreement for directors, officers, and certain stockholders (incorporated by reference to Exhibit 10.3 to the Form 8-K filed April 21, 2026)
10.4
Form of Amended and Restated Note, dated April 20, 2026 (incorporated by reference to Exhibit 10.4 to the Form 8-K filed April 21, 2026)
10.5
Form of Omnibus Signature Page to Securities Purchase Agreement (incorporated by reference to Exhibit 10.5 to the Form 8-K filed April 21, 2026)
10.6
Amendment to Amended and Restated Memorandum of Understanding, by and between Innovest S.p.A. and Milestone Scientific Inc., dated March 31, 2026.
10.7
Agreement With respect to Compensation and Other Arrangements, by and between Milestone Scientific Inc., Leonard Osser and U.S. Asian Consulting Group, LLC dated as of April 1, 2026.
10.8
Form of Lock-Up Agreements by Leonard Osser and Marilyn Elson in favor of Milestone Scientific Inc.
10.9
Executive Chairman Agreement between the Company and Benedetta Casamento, dated June 19,2026
10.10
Form of Option Exchange and Surrender Agreement ; Form of Notice of Stock Option Grant; Stock Option Agreement (for Repriced Options) ; 2026 Performance Incentive Sub-Plan to the Amended and Restated 2020 Equity Incentive Plan ; Form of Award Agreement under 2026 Performance Incentive Sub-Plan (incorporated by reference to
Exhibits 10.1-10.4 to the Form 8-K filed May 6, 2026
31.1
Principal Executive Officer Certification required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
31.2
Principal Financial Officer Certification required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
32.1
Certifications pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
101.INS
Inline
XBRL Instance Document*
101.SCH
Inline
XBRL Taxonomy Extension Schema Document*
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document*
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document*
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document*
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document*
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Filed
herewith.
**
Furnished
herewith and not filed, in accordance with item 601(32) (ii) of Regulation S-K.
28
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
MILESTONE
SCIENTIFIC INC.
/s/
Eric Hines
Eric
Hines
Chief
Executive Officer
(Principal
Executive Officer)
/s/
Keisha Harcum
Keisha
Harcum
Vice
President of Finance and Acting Chief Accounting Officer (Principal Financial and Accounting Officer)
Date:
August 13, 2026
29
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.