What changed in this filing

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Item 1A. Risk Factors

2025-03-27 compared with 2024-03-29 · 137 added, 146 removed, 265 unchanged (52% of the section changed)

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incurred net losses of $9,296,202 and $9,841,638 for the year ended December 31, 2024 and 2023, respectively.

We have not generated any

revenue to date, and we had accumulated deficit of $25,149,004 as of December 31, 2023.

We have developed our Sharps product

line but there can be no assurance that it will be commercially successful.

Our potential profitability is dependent upon a number of

factors, many of which are beyond our control.

We have not generated any revenue

to date, and we had an accumulated deficit of $34,445,206 as of December 31, 2024.

We have developed our Sharps product line but there can be no

assurance that it will be commercially successful.

Our potential profitability is dependent upon a number of factors, many of which are

beyond our control.

we are unable to achieve and sustain profitability, the value of our business and common stock may significantly decrease.

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revenues or achieve profitability.

may not succeed in commercializing Sharps products or any future product.

may face difficulties or delays in the commercialization of Sharps products, which could result in our inability

to timely offer products or services that satisfy the market.

may not succeed in commercializing Sharps Provensa products or any future product.

may face difficulties or delays in the commercialization of Sharps Provensa or other future products, which could result in our

inability to timely offer such products or services.

We may, for example, encounter difficulties due to:

our inability to adequately

market our products;

our inability to effectively

scale manufacturing as needed to maintain an adequate commercial supply of our products;

our inability to attract

and retain skilled support team, marketing staff and sales force necessary to increase the market for our products and to maintain

market acceptance for our products;

the difficulty of establishing

brand recognition and loyalty for our products.

addition, to increase our production capacity, we will need to build inventory, which will require that we purchase certain

additional equipment, including molding machines and molds.

We have not received any significant orders to date.

Even if we succeed

in building inventory, and increasing our production capacity, there is no assurance we will receive additional orders for our Sharps

= products or any future products.

inability to adequately market our products;

inability to effectively scale manufacturing as needed to maintain an adequate commercial supply of our products;

inability to attract and retain skilled support team, marketing staff and sales force necessary to increase the market for our products

and to maintain market acceptance for our products;

difficulty of establishing brand recognition and loyalty for our products.

In addition, to increase our production capacity, we will need to build

inventory, which will require that we purchase certain additional equipment, including molding machines and molds.

We have had no revenues

We have recently entered into supply and sales agreements for our Securegard

and Sologard products.

Even if we succeed in building inventory and increasing our production capacity, there is no assurance as to the

timing of orders for our products or any future products.

may encounter significant competition and may not be able to successfully compete.

are many medical device companies offering safety syringes, and more competitors are likely to arrive.

Some of our competitors have considerably

more financial resources than us.

As a result, we may not be able to successfully compete in our market, which could result in our failure

to successfully commercialize Sharps disposable syringe products or otherwise fail to successfully compete.

We anticipate that our major

domestic competitors will include Retractable Technologies, Inc., Becton, Dickinson & Company, Medtronic Minimally Invasive Therapies,

Terumo Medical Corp., Smiths Medical, and B Braun.

Some of our competitors have

considerably more financial resources than us.

As a result, we may not be able to successfully compete in our market, which could

result in our failure to successfully commercialize Sharps disposable syringe products or otherwise fail to successfully compete.

anticipate that our major domestic competitors will include Retractable Technologies, Inc., Becton, Dickinson & Company,

Medtronic Minimally Invasive Therapies, (“Medtronic,” formerly known as Covidien), Terumo Medical Corp., Smiths Medical,

There can be no assurances that we will be able to compete successfully in this environment.

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our products from being marketed abroad.

order to market and sell our Provensa product line and any additional medical device products we may develop in the future in the European

order to market and sell products, other than Securgard or Sologard, and any additional medical device products we may develop in the future in the European

Union and many other jurisdictions, we, and our collaborators, must obtain separate marketing approvals and comply with numerous and

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With respect to marketing authorizations in Europe, we will be required to submit

a European Marketing Authorisation Application, or MAA, to the European Medicines Agency, or EMA, which conducts a validation and scientific

a European Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, which conducts a validation and scientific

approval process in evaluating a product for safety and efficacy.

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quarantines, executive orders and similar government orders and restrictions for their residents to control the spread of COVID-19.

the manufacturing facility we operate continued to operate during the 2020-2021 COVID-19 pandemic due to its status as an essential

business, we cannot guarantee that the situation would be the same for any future pandemic.

In the future, we may elect or be required to close temporarily which would result in a disruption in our activities and operations.

Our supply chain, including transportation channels, may be impacted by any such restrictions as well.

Any such disruption could impact

our sales and operating results.

the manufacturing facility we operate continued to operate during the 2020-2021 COVID-19 pandemic due to its status as an essential business,

we cannot guarantee that the situation would be the same for any future pandemic.

In the future, we may elect or be required to close

temporarily which would result in a disruption in our activities and operations.

Our supply chain, including transportation channels,

may be impacted by any such restrictions as well.

Any such disruption could impact our sales and operating results.

health crises also negatively affect economies which could affect demand for our products.

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condition, and results of operations.

key personnel and other employees could still be affected by any future pandemic, which could affect our ability to operate

key personnel and other employees could still be affected by any future pandemic, which could affect our ability to operate efficiently.

business may be adversely affected by uncertainties in obtaining and enforcing intellectual property rights.

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commercially exploiting products similar to ours.

have four issued patents, two pending patent applications in the United States, and four PCT (Patent Cooperation Treaty) patent application.

We cannot be certain that we are the first inventor of the subject matter to which we have filed a particular patent application, or

if we are the first party to file such a patent application.

If another party has filed a patent application to the same subject matter

as we have, we may not be entitled to the protection sought by the patent application.

Further, the scope of protection of issued patent

claims is often difficult to determine.

As a result, we cannot be certain that the patent applications that we file will issue, or that

our issued patents will be broad enough to protect our proprietary rights or otherwise afford protection against competitors with similar

In addition, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability.

Our competitors

may challenge or seek to invalidate our issued patents, or design around our issued patents, which may adversely affect our business,

prospects, financial condition or operating results.

Also, the costs associated with enforcing patents, confidentiality and invention

agreements, or other intellectual property rights may make aggressive enforcement impracticable.

have four issued utility patents, two pending patent applications in the United States, and four PCT (Patent Cooperation Treaty)

patent application.

We cannot be certain that we are the first inventor of the subject matter to which we have filed a particular

patent application, or if we are the first party to file such a patent application.

If another party has filed a patent application

to the same subject matter as we have, we may not be entitled to the protection sought by the patent application.

Further, the scope

of protection of issued patent claims is often difficult to determine.

As a result, we cannot be certain that the patent

applications that we file will issue, or that our issued patents will be broad enough to protect our proprietary rights or otherwise

afford protection against competitors with similar technology.

In addition, the issuance of a patent is not conclusive as to its

inventorship, scope, validity or enforceability.

Our competitors may challenge or seek to invalidate our issued patents, or design

around our issued patents, which may adversely affect our business, prospects, financial condition or operating results.

costs associated with enforcing patents, confidentiality and invention agreements, or other intellectual property rights may make

aggressive enforcement impracticable.

distribution and sale by third parties of counterfeit versions of our products could have a negative impact on us.

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to regain compliance.

The Staff’s determination is based on the Company meeting the continued listing requirement for market value

of publicly held shares and all other applicable requirements for initial listing on the Capital Market with the exception of the bid

price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period

by effecting a reverse stock split, if necessary.

However, if it appears to the Staff that the Company will not be able to cure the deficiency,

the Staff will provide notice that its securities will be subject to delisting.

The Company will continue to monitor the closing bid

price of its Common Stock and will consider its available options to resolve the deficiency and regain compliance with the Minimum Bid

Price Requirement within the allotted compliance period.

There can be no assurance that the Company will regain compliance with the Minimum

Bid Price Requirement.

On October 7, 2024, the Company held a Special Meeting of its stockholders.

The Company’s stockholders approved

a proposal to authorize the Company’s Board in its discretion at any time within one year after stockholder approval is obtained,

to amend the Company’s Articles of Incorporation to effect a reverse stock split of shares of the Company’s common stock,

at a ratio with a range of 1-for-8 to 1 for 22, with the exact ratio to be determined by the Company’s Board.

The Board approved

the 1 for 22 reverse stock split on October 7, 2024 which went into effect on October 16, 2024.

Nasdaq notified the Company on November

13, 2024 that the Company regained compliance on November 5, 2024 with Listing Rule 5550(a)(2), (the “Bid Price Rule”).

On March 12, 2025, Sharps

Technology, Inc.

(the “ Company ”), was notified by the staff (the “ Staff ”) of The Nasdaq Stock Market,

LLC (“ Nasdaq ”) that it was not in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule

5550(a)(2) for continued listing on The Nasdaq Capital Market as the bid price of its securities had closed at less than $1.00 per share

over the previous 30 consecutive business days.

Normally, a company would be afforded a 180-calendar day period to demonstrate compliance

with the rule.

However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period due to

the fact that the Company has effected a reverse stock split over the prior one-year period or has effected one or more reverse stock

splits over the prior two-year period with a cumulative ratio of 250 shares or more to one.

The Company’s

securities will be delisted from the Nasdaq Capital Market unless the Company requests a hearing and appeals Nasdaq’s determination.

Accordingly, the Company filed a hearing request before the deadline which will automatically stay the delisting and suspension

of the Company’s securities pending the decision of the Nasdaq Hearings Panel (the “ Panel ”).

At the hearing,

the Company intends to present its views and its plans to regain compliance with the minimum bid price rule to the Panel.

no assurance that the Company will be able to evidence compliance with the minimum bid price rules or any other applicable requirements

for continued listing on The Nasdaq Capital Market prior to the hearing.

In the interim, the Company expects its common stock and warrants

will remain listed on Nasdaq under its existing symbols, “STSS” and “STSSW” while it awaits the hearing

Staff’s determination is based on the Company meeting the continued listing requirement for market value of publicly held

shares and all other applicable requirements for initial listing on the Capital Market with the exception of the bid price

requirement, and the Company’s written notice of its intention to cure the deficiency by effecting a reverse stock split, if

However, if it appears to the Staff that the Company will not be able to cure the deficiency, the Staff will provide

notice that its securities will be subject to delisting.

The Company will continue to monitor the closing bid price of its Common

Stock and will consider its available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement

within the allotted compliance period.

There can be no assurance that the Company will regain compliance with the Minimum Bid Price

will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time

to compliance with our public company responsibilities and corporate governance practices.

a public company, we will incur significant legal, accounting and other expenses, which we

expect to further increase after we are no longer an “emerging growth company.” The Sarbanes-Oxley Act, the Dodd-Frank Wall

Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Capital Market, and other applicable securities rules

and regulations impose various requirements on public companies.

Our management and other personnel will devote a substantial amount

of time to compliance with these requirements.

Moreover, these rules and regulations will increase our legal and financial compliance

costs and will make some activities more time-consuming and costly.

We cannot predict or estimate the amount of additional costs we will

incur as a public company or the specific timing of such costs.

a public company, we will incur significant legal, accounting and other expenses, which we expect to further increase after we are no

longer an “emerging growth company.” The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act,

the listing requirements of the Nasdaq Capital Market, and other applicable securities rules and regulations impose various requirements

on public companies.

Our management and other personnel will devote a substantial amount of time to compliance with these requirements.

Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming

We cannot predict or estimate the amount of additional costs we will incur as a public company or the specific timing of

a result of being a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting,

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result, the value of our common stock.

are required for 2023, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness

of our internal control over financial reporting as of the end of the fiscal year that coincides with the filing of our second annual

report on Form 10-K.

This assessment will need to include disclosure of any material weaknesses identified by our management in our internal

control over financial reporting.

In addition, our independent registered public accounting firm may be required to attest to the effectiveness

of our internal control over financial reporting in our first annual report required to be filed with the SEC following the date we are

no longer an “emerging growth company.” We have commenced the costly and time-consuming process of compiling the

system and processing documentation necessary to perform the evaluation needed to comply with Section 404, and we expect to be able to

complete our evaluation, testing and any required remediation in a timely fashion.

Our compliance with Section 404 will

require that we incur substantial expenses and expend significant management efforts.

We currently do not have an internal audit group,

and we in the future we may need to hire additional accounting and financial staff with appropriate public company experience and technical accounting

knowledge and compile the system and process documentation necessary to perform the evaluation needed to comply with Section 404.

are required for 2023 and after, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things,

the effectiveness of our internal control over financial reporting as of the end of the fiscal year that coincides with the filing

of our annual report on Form 10-K.

This assessment will need to include disclosure of any material weaknesses identified by

our management in our internal control over financial reporting.

In addition, our independent registered public accounting firm may

be required to attest to the effectiveness of our internal control over financial reporting in our first annual report required to

be filed with the SEC following the date we are no longer an “emerging growth company.” We have commenced the costly and

time-consuming process of compiling the system and processing documentation necessary to perform the evaluation needed to comply

with Section 404, and we expect to be able to complete our evaluation, testing and any required remediation in a timely fashion.

compliance with Section 404 will require that we incur substantial expenses and expend significant management efforts.

do not have an internal audit group, and we in the future we may need to hire additional accounting and financial staff with

appropriate public company experience and technical accounting knowledge and compile the system and process documentation necessary

to perform the evaluation needed to comply with Section 404.

current controls and any new controls that we develop may become inadequate because of changes in conditions in our business.

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many of which are beyond our control, including the following:

actual or anticipated fluctuations

in our financial condition or results of operations;

variance in our financial

performance from expectations of securities analysts;

changes in our projected

operating and financial results;

changes in laws or regulations

applicable to our products;

announcements by us or

our competitors of significant business developments, acquisitions or new products;

sales of shares of our

common stock by us or our shareholders, as well as the anticipation of lock-up releases;

our involvement in litigation;

future sales of our common

stock by us or our stockholders;

changes in senior management

or key personnel;

the trading volume of our

common stock;

changes in the anticipated

future size and growth rate of our market;

general economic and market

other events or factors,

including those resulting from war, incidents of terrorism, global pandemics or responses to these events.

or anticipated fluctuations in our financial condition or results of operations;

in our financial performance from expectations of securities analysts;

in our projected operating and financial results;

in laws or regulations applicable to our products;

announcements

by us or our competitors of significant business developments, acquisitions or new products;

of shares of our common stock by us or our shareholders, as well as the anticipation of lock-up releases;

involvement in litigation;

sales of our common stock by us or our stockholders;

in senior management or key personnel;

trading volume of our common stock;

in the anticipated future size and growth rate of our market;

economic and market conditions;

events or factors, including those resulting from war, incidents of terrorism, global pandemics or responses to these events.

market and industry fluctuations, as well as general economic, political, regulatory and market conditions, may also negatively impact

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of our common stock or result in dilution to our existing stockholders.

holder of our Series A Preferred Stock will have 29.5 % of the voting power of our stockholders for the election of directors and will

have certain senior rights upon sale of our Company under certain conditions.

is 1 share of Series A Preferred Stock issued and outstanding, which is held by our co-chairman and chief operating officer, Alan Blackman.

The Series A Preferred Stock entitles the holder to 29.5% of the voting power of the Company’s stockholders only as it relates

to the elections of directors.

As a result, Mr.

Blackman is able to exert substantial influence over the election of directors to the

However, as discussed above, Mr.

Blackman resigned

from the Board of the Company effective July 27, 2023.

Additionally, in connection with Mr.

Blackman’s resignation, once his severance

payments are satisfied, Mr.

Blackman shall return the Series A Preferred Stock to the Company for cancellation.

In the meantime, Mr.

Blackman has granted the right to vote the Preferred Stock outstanding.

the Series A Preferred Stock, provides that in the event the Company is sold during the two year period following completion of the offering

at a price per share of more than 500% of $ t he

inital offering price per Common Stock unit in this offering, the Series A Preferred Stock will entitle the holder to 10% of the total

purchase price.

This may reduce the value of our common stock, as other holders, in the event of such an acquisition, will be entitled

to a lower price per share than they would otherwise receive.

executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly

influence all matters submitted to stockholders for approval.

executive officers, directors and principal stockholders in the aggregate, beneficially own approximately 14.5% of our common stock.

persons acting together, will have the ability to control or significantly influence all matters submitted to our stockholders for approval,

as well as our management and business affairs.

This concentration of ownership may have the effect of delaying, deferring or preventing

a change in control, impeding a merger, consolidation, takeover or other business combination involving us, or discouraging a potential

acquiror from making a tender offer or otherwise attempting to obtain control of our business, even if such a transaction would benefit

other stockholders.

Future securities issuances

could result in significant dilution to our stockholders and impair the market price of our common stock.

Future issuances of shares

of our common stock could depress the market price of our common stock and result in dilution to existing holders of our common stock.

Also, to the extent outstanding options and warrants to purchase our shares of our common stock are exercised or options or other equity-based

awards are issued or become vested, there will be further dilution.

The amount of dilution could be substantial depending upon the size

of the issuances or exercises.

Furthermore, we may issue additional equity securities that could have rights senior to those of our common

stock offerings in the future may dilute then-existing shareholders’ percentage ownership of the Company.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors