Company: MLSS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022276
Chunk: 7

Company: MILESTONE SCIENTIFIC INC.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 7
---
, dermatology, orthopedics,
and many other disciplines. The dental devices are sold in the United States, Canada, and 49 other countries. Specific medical
devices have obtained CE mark approval and can be marketed and sold in most European countries. In June 2017, Milestone
Scientific received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo®
Epidural Computer Controlled Anesthesia System (“Epidural”). 

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 unaudited condensed financial statements.

The Company has incurred aggregate losses of
approximately $132.7
million since its inception. Operating losses were approximately $1.1
million and $4.6
million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, The Company had
cash and cash equivalents of approximately $1.3
million and working capital of approximately $3.1
million. For the nine months ended September 30, 2025, and 2024, cash flows used in operating activities were approximately $2.7
million and $1.4
million, respectively.

Based
on our available cash and cash equivalents, recurring losses, accumulated deficit and the need to raise additional capital to finance
operations, as of September 30, 2025, we have concluded that
there is substantial doubt about our ability to continue as a going concern for a period of one year from the date that these unaudited
condensed financial statements are issued.

We
will seek additional funding through equity financings or debt financings to support our current operating plan. Although management
intends to pursue plans to obtain additional funding to finance its operations, and we have successfully raised capital in the past,
we may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or
rights of the Company’s stockholders.

We
are actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental
business worldwide, the generation of revenue from its medical