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Milestone Scientific (MLSS) Risk Analysis
Risk Overview Q2, 2026
Risk Change Over Time
- Share Price & Shareholder Rights - Risk 1Our 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.
Risk Highlights Q2, 2026
Risk Word Cloud
Risk Factors Full Breakdown - Total Risks 49
- Share Price & Shareholder Rights - Risk 1ChangedOur 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.
- Share Price & Shareholder Rights - Risk 2AddedOur 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.
- Share Price & Shareholder Rights - Risk 3Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact the price of our common stock.
Almost all our 80,453,116 outstanding shares of common stock on December 31, 2025, are available for sale in the public market, either freely or pursuant to Rule 144 under the Securities Act of 1933, as amended. Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact the price of our common stock.
- Share Price & Shareholder Rights - Risk 4Raising additional capital 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.
If we raise additional capital through the issuance of equity securities, the share ownership of existing stockholders will experience dilution. Debt financing could include covenants that restrict our operations, including limitations on our ability to incur liens or additional indebtedness, pay dividends, redeem stock, make certain investments, or engage in particular merger, consolidation, or asset sale transactions. If we raise funds through licensing arrangements or asset dispositions, we may be required to relinquish valuable rights to product candidates or grant licenses on terms that are unfavorable.
- Share Price & Shareholder Rights - Risk 5The Company is effectively controlled by a limited number of stockholders.
Our principal stockholder, BP4, Srl, an Italian investment vehicle that is currently in liquidation ("BP4"), controls approximately 11.05% of the Company's issued and outstanding shares of common stock. As a result, it can exercise substantial control over our affairs and corporate actions requiring stockholder approval, including electing directors, selling all or substantially all our assets, merging with another entity, or amending our certificate of incorporation. This control could delay, deter, or prevent a change in control and could adversely affect the price that investors might be willing to pay in the future for the Company's securities. Because of the concentration of ownership of our shares of common stock, our stockholders may from time to time observe instances where there may be less liquidity in the public markets for our securities.
- Share Price & Shareholder Rights - Risk 6We have relied heavily on sales of our common stock to fund our operations, and our ability to obtain additional capital through stock sales or other securities offerings may be more costly or dilutive to our stockholders than in the past, or may not be available to us at all. Our ability to raise additional capital may be limited by a low trading volume, stock price and market capitalization, as well as by laws, regulations and market conditions.
We have historically relied on, and may continue to rely, the sale of shares of our common stock to fund our operations and support our business activities. Our ability to raise additional capital through sales of our common stock or other securities offerings will depend on several factors, many of which may not be in our favor, including the trading volume and volatile trading price of our common stock, our relatively low public float and market capitalization, our potential inability maintain compliance with the listing requirements of the NYSE American, unfavorable financial market conditions, and the other risks and uncertainties. If we are unable to raise additional capital through the offering and sale of shares of our common stock, or securities convertible into or exercisable for our common stock, on a timely basis or on acceptable terms, or at all, we may seek additional capital through other third-party sources that require us to relinquish valuable rights in our intellectual property, technologies, product candidates or future revenue streams, or that subject us to restrictive covenants, operational restrictions or security interests in our assets, or we may need to delay, scale back or eliminate some or all of our development programs, reduce other expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. Using a shelf registration statement to conduct an equity offering to raise capital generally takes less time and is less expensive than other means, such as conducting an offering under a Form S-1 registration statement. Our ability to raise capital under a shelf registration statement is, and may continue to be, limited by, among other things, current and future SEC rules and regulations impacting on the eligibility of smaller companies to use Form S-3 for primary offerings of securities. For example, if we filed a new shelf registration statement, we would currently be subject to the "baby shelf rule." This means that we could use a shelf registration statement to raise additional funds only to the extent that the aggregate market value of securities sold by us or on our behalf pursuant to Instruction I.B.6. of Form S-3 during the 12 calendar months immediately prior to, and including, the intended sale does not exceed one-third of the aggregate market value of our public float, calculated in accordance with the instructions to Form S-3. Based on the aggregate market value of our public float, we would currently be unable to raise significant capital under a shelf registration. If our ability to offer securities under a shelf registration statement is limited, including by the baby shelf rule, we could choose to conduct an offering of our securities under an exemption from registration under the Securities Act or under a Form S-1 registration statement. We would expect either of these alternatives to take more time and be a more expensive method of raising additional capital relative to using our shelf registration statement. In addition, under SEC rules and regulations, our common stock must be listed and registered on a national securities exchange in order to use a Form S-3 registration statement (1) for a primary offering, if our public float is not at least $75 million as of a date within 60 days prior to the date of filing the Form S-3 or a re-evaluation date, whichever is later, There can be no assurance that we can maintain the listing of our common stock on the NYSE American. See, "If we fail to regain compliance with the strict listing requirements of NYSE American, we may be subject to delisting. As a result, our stock price may decline, and our common stock may be de-listed. If our stock were no longer listed on NYSE American, the liquidity of our securities likely would be impaired," above. Our ability to raise capital on a timely basis through the issuance and sale of equity securities may also be limited by NYSE American's stockholder approval requirement for certain issuances, including certain transactions that are not deemed a public offering (as defined in the Company Guide). For transactions other than public offerings, the Company Guide requires stockholder approval prior to the issuance or potential issuance of common stock (or securities convertible into or exercisable for common stock) at a price per share that is less than the "Minimum Price" if the issuance (together with sales by our officers, directors and principal shareholders (as defined in Company Guide)) would equal 20% or more of our common stock outstanding before the issuance. Under the Company Guide, the "Minimum Price" means a price that is the lower of (i) the Official Closing Price immediately preceding the signing of the binding agreement; or (ii) the average Official Closing Price for the five trading days immediately preceding the signing of the binding agreement. For purposes of calculating the Minimum Price, the "Official Closing Price" of the issuer's common stock means the official closing price on the NYSE American as reported to the consolidated tape immediately preceding the signing of a binding agreement to issue the securities. In addition, certain prior sales of securities by us may be aggregated with any offering we may propose at a price that is less than the Minimum Price and which is not considered a public offering by the Company Guide, further limiting the amount we could raise in the offering. Under the Company Guide, stockholder approval is also required prior to the issuance of securities when the issuance or potential issuance will result in a change of control of our company. Even if a public offering under the Company Guide is not subject to the limitations described above, it may involve publicly announcing the proposed transaction, which often has the effect of depressing the market price of a company's stock and could result in a reduced offering price. Accordingly, our existing investors may suffer greater dilution if we seek to raise additional capital through such a public offering of our securities. Obtaining stockholder approval is a costly and time-consuming process. If we must obtain stockholder approval for a potential transaction, we would expect to spend substantial additional money and resources. In addition, seeking stockholder approval would delay our receipt of otherwise available capital, which may materially and adversely affect our ability to execute our business plan, and there is no guarantee our stockholders ultimately would approve a proposed transaction.
- Share Price & Shareholder Rights - Risk 7The market price of our common stock may be volatile and may fluctuate significantly, and stockholders could lose all or part of their investment in the Company.
The market price for our common stock varied between a high of $1.39 and a low of $0.23 during the twelve months ended December 31, 2025. Our stock price is likely to continue to be volatile and subject to significant price and volume fluctuations in response to market and other factors, including those listed in this "Risk Factors" section and other, unknown factors. Our stock price may experience substantial volatility because of many factors, including: - our failure to meet analysts' expectations; - sales or potential sales of substantial amounts of our common stock; - delay or failure in initiating our strategy to commercialize our CompuFlo Epidural System; - the success of our strategy to commercialize our CompuFlo Epidural System; - announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions that could adversely impact the market acceptance or competitive advantages of our CompuFlo Epidural System; - developments concerning our licensors or product manufacturers;- litigation and other developments relating to our patents or other proprietary rights or those of our competitors; - our ability to successfully develop and commercialize products and services for the healthcare industry; - conditions in the medical device industry; - variations in our anticipated or actual operating results; and - change in securities analysts' estimates of our performance, or our failure to meet analysts' expectations. Many of these factors are beyond our control. The stock markets in general, and the market for small, medical device companies have historically experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance.
- Share Price & Shareholder Rights - Risk 8Provisions in our certificate of incorporation, our by-laws and Delaware law might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
Provisions of our certificate of incorporation, our by-laws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our company or changes in our management, including transactions in which our stockholders might otherwise receive a premium for their shares over then current market prices. In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests. These provisions include: - the inability of stockholders to call special meetings;- the ability of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could include the right to approve an acquisition or other change in our control or could be used to institute a rights plan, also known as a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our Board of Directors; and - limitations on filling of vacancies. All of which could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control of our company. In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. The existence of the forgoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our common stock. They could also deter potential acquirers of our Company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.
- Share Price & Shareholder Rights - Risk 9Your percentage of ownership in the Company may be diluted in the future.
In the future, your percentage ownership in the Company may be diluted because of equity issuances for acquisitions, capital market transactions or otherwise, including any equity awards that the Company will grant to its directors, officers, employees and consultants. Such awards will have a dilutive effect on outstanding share count which could adversely affect the market price of the Company's common stock.
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