Company: MLSS
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001437749-25-012050
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Company: MILESTONE SCIENTIFIC INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
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Item 1A. Risk Factors

You should consider carefully the risks and uncertainties described below, together with all the other information in this Annual Report on Form 10-K. If any of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. The risks described below are not the only risks facing us. Risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, results of operations and/or prospects.

Risks Related to Our Financial Position and Need for Additional Capital

We have incurred significant losses since our inception. These operating losses are expected to continue, and we are unable to predict the extent of future losses, whether we will generate significant revenues or whether we will achieve or sustain profitability.

We are a small, non-diversified medical device company with a history of limited revenue and significant operating losses, and our prospects must be evaluated considering the uncertainties, risks, expenses, and difficulties frequently encountered by similarly situated companies. The Company has generated net losses in all periods since the commencement of our operations. The operating losses were $6.8 million and $7.1 million, for the years ended December 31, 2024, and 2023, respectively.

Our losses have had, and are expected to continue to have, an adverse impact on our working capital, total assets, and stockholders' equity. Because of the risks and uncertainties associated with product acceptance and sales expansion, we are unable to predict the extent of any future losses, whether we will ever generate significant revenues or if we will ever achieve or sustain profitability. Even if we do generate profits from operations, we may not be able to achieve, sustain or increase profitability on a quarterly or annual basis. Our failure to generate substantive profits from operations and to become and remain profitable could impair our ability to raise capital, expand our business, and maintain our commercial efforts or continue our operations. A decline in the value of our company could also cause our shareholders to lose all or part of their investment.

We anticipate that we will need additional funding for our operations and may be unable to raise capital when needed, which may force us to delay, curtail or eliminate parts of the Company’s operations.

Our operations have consumed substantial amounts of cash since inception. During the years ended December 31, 2024 and 2023, net cash flow used in operations was approximately $2.9 million and approximately $5.3 million, respectively.