What changed in this filing

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Item 7. Management’s Discussion and Analysis

2024-03-29 compared with 2023-03-31 · 175 added, 168 removed, 298 unchanged (54% of the section changed)

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made, and we do not assume any obligation to update any forward-looking statements .

our inception in 2017, we have devoted substantially all of our resources to the research and development of our safety syringe products.

our inception in 2017 and through the fourth quarter of 2022, we have devoted substantially all of our resources to the research and

development of our safety syringe products Commencing in the fourth quarter of 2022 we started building inventory of syringe products.

To date, we have generated no revenue.

We have incurred net losses in each year of $4,639,662 and $4,664,412 for the years ended December

We have incurred net losses of $9,841,638 and $4,639,662 for the years ended December

31, 2023 and 2022, respectively.

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located in Melville, New York, but employees and consultants in the US work remotely and will continue to do so indefinitely.

June 2020, in connection with the agreement to acquire Safegard, a former syringe manufacturing facility in Hungary, which was

completed on July 6, 2022, we were contractually provided the exclusive use of the facility for research and development and testing

in exchange for payment of the seller’s operating costs, including among others, use of Safegard’s work force, utility

costs and other services.

2020, in connection with the agreement to acquire Safegard, a syringe manufacturing facility in Hungary, which was completed on

July 6, 2022, we were contractually provided the exclusive use of the facility for research and development and testing in exchange for

payment of the seller’s operating costs, including among others, use of Safegard’s work force, utility costs and other services.

order to compete in the market, we must build inventory.

Commencing in the 4 th Quarter of 2022 we have started building inventory.

Commencing in the 4 th Quarter of 2022 started building

We require commercial quantities of inventory to secure orders.

Delivery is expected shortly after receiving orders.

Delivery is expected shortly after receiving

and Development

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our Chief Technology Officer;

costs paid to Safegard, through the acquisition date for use of Safegard’s workforce, utilities and other services, relating to

the facility being utilized;

costs, including engineering, incurred for development and design.

Operating costs paid to

Safegard, through the acquisition date for use of Safegard’s workforce, utilities and other services, relating to the facility

being utilized;

Third-party costs, including

engineering, incurred for development and design.

Substantially

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We expect our research

and development expenses to increase for the foreseeable future as we continue to enhance our product to meet the market requirements

for our Sharps Provensa product line for its various intended uses throughout the world.

and development expenses to increase for the foreseeable future as we continue to enhance our products to meet the market requirements

for our Sharps syringe product line for its various intended uses throughout the world.

Public Offering

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September 29, 2022, the Company entered into an agreement (the “NPC Agreement”) with Nephron Pharmaceuticals Corporation

(“NPC”) and various affiliates of NPC, including InjectEZ, LLC, that we believe will provide multiple future opportunities

for the Company.

The NPC Agreement is for a period of four (4) years, expiring on September 28, 2026, and continues thereafter for successive

one (1) year periods.

NPC Agreement is intended to support several areas of the Company’s development and growth.

The Company and NPC intend to

supplement the NPC Agreement by entering into a manufacturing supply agreement, a sales and distribution agreement and a pharma

services program to support growth, and a future agreement to support manufacturing expansion.

manufacturing and supply agreement will be focused on the development and manufacture of high value pre-fillable syringe systems that

can be utilized by Nephron which are highly sought after by the healthcare industry and pharmaceutical markets, with projected product

supply beginning in mid-2023.

The syringe lines will utilize highly automated equipment and controlled environments established by Nephron.

These premium offerings will be made from what we believe are the highest quality raw materials, on the most innovative technology.

products will be compliant with the USP standards required in the United States, as well as the EP and JP international standards, as applicable The

products that the Company and Nephron intend to develop and commercialize are designed to provide solutions to support Nephron’s

current fill/finish strategies, as well as their pipeline of new drug applications, and sets forward a strategy to support branded pharma

and advanced therapies including ophthalmic and biologic applications.

Our seasoned understanding of pharma fill/finish processes and

equipment and strong connections with preferred component suppliers and large pharmaceutical companies sets the groundwork for an effective

market strategy in partnership with Nephron.

December 8, 2022, the Company completed the sales and distribution agreement (the “Distribution Agreement”) portion of the

overall agreement with Nephron Pharmaceuticals Corporation and Nephron SC, Inc.

(collectively, “Nephron”), pursuant to which

the Company appointed Nephron as its exclusive distributor for the sale and distribution of the products subject to the Distribution

Agreement in and throughout the United States.

Pursuant to the Distribution Agreement, the price of shipping products will be based on

the cost of delivery to Nephron’s warehouse and the Company will pay for the cost of delivery to Nephron.

The Distribution Agreement

has a term of two years and will continue in effect unless either party notifies the other party of its desire to terminate.

and for any reason, either party can terminate the Distribution Agreement after thirty (30) days’ notice and in the event of a

breach of any of the Distribution Agreement’s terms and provisions, either party can terminate the Distribution Agreement by providing

90 days written notice.

The Company has the right to terminate the Distribution Agreement with 60 days written notice in the event that

certain conditions are met as set forth in the Distribution Agreement.

Company’s collaboration will include the creation of a Pharma Services Program (PSP) designed to support Healthcare customers that

need innovative solutions and products to support their business.

This program will create new business development growth opportunities

for both companies.

We believe that these opportunities for the Company will include the development and sale of next generation drug

delivery systems for Nephron products, the healthcare industry, and pharmaceutical markets.

The development of the program will help

create new fill/finish project opportunities that will utilize innovative packaging solutions developed by the Company.

These new customer

projects will help create a future pipeline of growth for both companies working together.

Initial, and currently confidential, projects

have been identified and will be further developed through the collaboration efforts of Nephron and the Company.

The opportunity to create

new innovative technologies to support Nephron and the healthcare industry would be transformative for the Company and its future.

Company will be working with Nephron on plans for future expansion, innovation, collaboration and building for long-term success.

further support the planned growth for the Pharma Services Program, we will be working to expand our U.S.

operations in South Carolina

with the help of NPC.

This expansion may include the construction of an additional manufacturing facility, located on the Nephron campus,

that would be focused on the manufacture of specialized drug delivery technologies to support Nephron and the healthcare and pharmaceutical

Through this plan of accelerated expansion, we believe that the Company will be able to deliver increased capacity, driving

growth and ultimately, profitability for the high value products’ segment of our business.

(“NPC”) and various affiliates of NPC, including InjectEZ, LLC.

The NPC Agreement intended to support several areas of

the Company’s development and growth.

The Company and NPC intended to supplement the NPC Agreement by entering into a manufacturing

supply agreement, a sales and distribution agreement and a pharma services program to support growth, and a future agreement to support

manufacturing expansion.

As noted below, the sales and distribution agreement was terminated on March 8, 2024 and replaced.

manufacturing supply agreement, noted above, will be replaced as part of the Asset Purchase Agreement, entered into on September 22,

2023 (see below) and the Pharma Services agreement continues to be in place, but no activities have occurred to date.

The Company is currently working to amend the terms of this NPC Agreement.

based on the below September 22, 2023

Asset Purchase Agreement.

Pharma Services Program (PSP) with Nephron is intended to create new business development growth opportunities for both companies.

opportunities will include the development and sale of next generation drug delivery systems that will be produced by the Company and can

be purchased by the healthcare industry, pharmaceutical markets, as well as by Nephron.

September 29, 2022, the Company also entered into an agreement (the “Nephron Agreement”) with InjectEZ, LLC

(“InjectEZ”), Nephron Pharmaceuticals Corporation (“NPC”), Nephron SC, Inc.

(“NSC”), and Nephron

Sterile Compounding Center LLC (“Sterile”) (NPC, NSC, and Sterile are sometimes collectively referred to as

“Nephron”), pursuant to which the Company was to provide technical advice and assistance to support manufacturing by

InjectEZ, purchase certain quantities of syringes as they may order or require, and collaborate with Nephron on certain related

business endeavors.

The Company is currently working to amend the terms of the Nephron Agreement

based on the below September 22, 2023 Asset Purchase Agreements.

September 22, 2023, the Company entered into a series of agreements with Nephron and Nephron’s wholly owned subsidiary InjectEZ, LLC.

The Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) to purchase certain equipment and leasehold

improvements at Nephron’s facility (the “Facility”) in West Columbia, South Carolina.

The Company continues to work

with Nephron towards the purchase of the Nephron facility pursuant to the Asset Purchase Agreement dated September 22, 2023.

Purchase Agreement, when closed, will supercede the manufacturing and supply agreement entered into in connection with the NPC Agreement

on September 29, 2022.

The closing of the Asset Purchase Agreement is contingent on obtaining the necessary financing and there can be no

assurance that the closing of the asset sale will occur.

March 4, 2024 (the “Effective Date”) the Company entered into a cooperative sales and distribution agreement (the “Agreement)

with Roncadelle Operations s.r.l (“ Roncadelle”)).

In conjunction with the execution of the Agreement, Roncadelle appointed

the Company as its exclusive distributor of Roncadelle products in the United States, Canada, Central and South America and their territories.

The Company appointed Roncadelle as its exclusive distributor of Sharps products in Europe, Middle East, APAC, South Africa and Australia

and their territories.

The Company and Roncadelle agreed to bear their own separate costs and expenses, including fees and other expenses,

relating to external advisors and the preparation, negotiation, execution and performance of this Agreement and any related documents.

The Agreement is effective as of the Effective Date for the initial period of one (1) year (the “Initial Term”).

Upon expiration

of the Initial Term, the term of the Agreement shall automatically renew for additional successive one year terms, unless either party

provides written notice of non-renewal at least ninety (90) days prior to the end of the then-current term, unless any renewal term is

terminated earlier pursuant to the terms of the Agreement or applicable law.

(See “Recent Developments”)

March 8, 2024, the Company and Nephron Pharmaceuticals Corporation terminated their distribution agreement dated December 8, 2022.

Nephron distribution agreement has been partially replaced by the aforementioned Agreement with Roncadelle on the foreign sales side

and plans to use other parties to distribute for the US domestic market.

The Company entered into a new logistics services agreement

on the warehousing side with Owens and Minor (“O&M”) to replace Nephron’s distribution services.

The Company had

no revenues from the Nephron Distribution Agreement and does not believe that the cancellation is material.

The Company is currently

negotiating its contract with O&M to provide 3PL services for both the Company and Roncadelle products, in North and South America,

beginning in the third quarter of 2024.

The Company and Nephron continue to maintain the Pharma Services Program that focuses on the

creation of new business development and growth opportunities for both companies.

These opportunities will include the development and

sale of next generation drug delivery systems that will be produced by the Company and can be purchased by the healthcare industry, pharmaceutical

markets, and Pharma companies such as Nephron and others.

February 3, 2023, the Company completed a securities purchase agreement (“Offering”) with institutional investors and received

net proceeds from the Offering were approximately $3.2 million, net of $600,000 in fees relating to the placement agent and other offering

net proceeds from the Offering of approximately $3.2 million, net of $600,000 in fees relating to the placement agent and other offering

The Offering was priced at the market under Nasdaq rules.

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Each unit consists of one share of common stock and one non-tradable warrant exercisable for one

share of common stock at a price of $1.56.

The warrants have a term of five years from the issuance date.

share of common stock at a price of $.64, as adjusted down from $1.56 as per terms of the warrants.

The warrants have a term of five

years from the issuance date.

(See Notes 8 and 10 to the Consolidated Financial Statements)

September 29, 2023, the Company completed two simultaneous offerings and received aggregate gross proceeds of approximately $5.6 million,

before expenses to the placement agent and other offering expenses of $716,000.

first offering, the securities purchase agreement offering (the “Shelf Offering”) with institutional investors and the

Company resulted in the Company receiving net proceeds from the Shelf Offering and the sale of pre-funded warrants of approximately

$2.5 million, includes the value of the pre-funded warrants recorded in Additional Paid in Capital, net of $362,000 in fees relating to the placement

agent and other offering expenses.

The Shelf Offering was priced at the market under Nasdaq rules.

In connection with the Shelf

Offering, the Company issued 3,618,521 shares of common at a purchase price of $0.64 per unit and 800,000 pre-funded warrants at

$0.639 per pre-funded warrants.

The exercise price of the pre-funded warrants will be $0.001 per share.

second offering, the securities purchase agreement offering (“Private Placement”) with institutional investors and the

Company received net proceeds from the Private Placement of approximately $2.4 million, net of $354,000 in fees relating to the placement

agent and other offering expenses.

In connection with the Private Placement, the Company issued:

(i) 2,581,479 PIPE Shares (or PIPE

Pre-Funded Warrants in lieu thereof) and (ii) PIPE Warrants (non-trading) to purchase 8,750,003 shares of our common stock, at a

combined purchase price of $1.074 per unit (or $1.073 per pre-funded unit).

The PIPE Warrants have a term of five and one-half (5.5)

years from the issuance date and are exercisable for one share of common stock at an exercise price of $0.64.

The net proceeds, after

reflecting par value, has been recorded in Additional Paid in Capital of $1.6 million and with respect to the PIPE Warrants recorded

as a liability under ASC 815 of $985,204.

On October 16, 2023, the Company filed an S-1 (Resale) Registration Statement in connection

with the Private Placement and on October 26, 2023 the S-1 went effective.

At December 31, 2023 the warrant liability is $1,036,875.

( See Notes 8 and 10 to the Consolidated

Financial Statements)

Accounting Policies and Significant Judgments and Estimates

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Cash and cash equivalents are maintained with various financial institutions.

At December 31, 2023 and 2022, the Company had no cash equivalents

Company values inventory at the lower of cost (average cost) or net realizable value.

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measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from

and Purchased Identified Intangible Assets

applicable, goodwill will be recorded as the difference, if any, between the aggregate consideration paid for an acquisition and the

fair value of the net tangible and identified intangible

assets acquired under a business combination.

Goodwill also includes acquired assembled workforce, which does not qualify as an identifiable

intangible asset.

The Company reviews impairment of goodwill annually in the third quarter, or more frequently if events or circumstances

indicate that the goodwill might be impaired.

The Company first assesses qualitative factors to determine whether it is necessary to

perform the quantitative goodwill impairment test.

If, after assessing the totality of events or circumstances, the Company determines

that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then the quantitative goodwill

impairment test is unnecessary.

If, based on the qualitative assessment, it is determined that it is more likely than not that the fair

value of a reporting unit is less than its carrying amount, then the Company proceeds to perform the quantitative goodwill impairment

The Company first determines the fair value of a reporting unit using weighted results derived from an income approach and a market

The income approach is estimated through the discounted cash flow method based on assumptions about future conditions such

as future revenue growth rates, new product and technology introductions, gross margins, operating expenses, discount rates, future economic

and market conditions, and other assumptions.

The market approach estimates the fair value of the Company’s equity by utilizing

the market comparable method which is based on revenue multiples from comparable companies in similar lines of business.

then compares the derived fair value of a reporting unit with its carrying amount.

If the carrying value of a reporting unit exceeds

its fair value, an impairment loss will be recognized in an amount equal to that excess, limited to the total amount of goodwill allocated

to that reporting unit.

Intangible Assets

applicable, the Company’s identified intangible assets are amortized on a straight-line basis over their estimated useful lives.

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liabilities are re-measured at each balance sheet date until their exercise or expiration, and any change in fair value is recognized

in the Company’s consolidated statement of operations and comprehensive loss (See Notes 7, 8 and 10 to the Consolidated

Financial Statements).

in the Company’s consolidated statement of operations and comprehensive loss (See Notes 7, 8 and 10 to the Consolidated Financial

and Diluted Loss Per Share

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ASC 260 requires presentation of both basic and diluted

earnings per share (EPS) on the face of the consolidated statement of operations and comprehensive loss.

Basic EPS is computed by dividing

net income (loss) available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during

Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method

and convertible preferred stock using the if-converted method.

In computing diluted EPS, the average stock price for the period is used

in determining the number of shares assumed to be purchased from the exercise of stock options or warrants.

Diluted EPS excludes all

dilutive potential shares if their effect is anti-dilutive.

As at December 31, 2022, there were 10,405,916 stock options and warrants

that could potentially dilute basic EPS in the future that were not included in the computation of diluted EPS because to do so would

have been antidilutive for the periods presented.

earnings per share (EPS) on the face of the consolidated statements of operations.

Basic EPS is computed by dividing net income (loss)

available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period.

EPS includes the 3,381,479 of pre-funded warrants (see Note 8).

Diluted EPS gives effect to all dilutive potential common shares outstanding

during the period using the treasury stock method and convertible preferred stock using the if-converted method.

In computing diluted

EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of

stock options or warrants.

Diluted EPS excludes all dilutive potential shares if their effect is anti-dilutive.

As of December 31, 2023,

there were 22,950,155 stock options and warrants that could potentially dilute basic EPS in the future that were not included in the

computation of diluted EPS because to do so would have been anti-dilutive for the periods presented.

Company must make certain estimates and judgments in determining income tax expense for financial statement purposes.

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Foreign currency Loss

Deferred Tax (Benefit)

Company has not generated any revenue to date.

and Development

the year ended December 31, 2022, Research and Development (“R&D”) expenses increased to $2,280,933 compared to $1,690,865

the year ended December 31, 2023, Research and Development (“R&D”) expenses decreased to $1,605,547 compared to $2,280,933

for the year ended December 31, 2022.

The increase of $590,068 was due to increased R&D costs incurred at Safegard for labor $181,000

and other costs $207,000, which commenced after the acquisition on July 6, 2022.

In addition, we had increases in depreciation related

to R&D equipment of $597,000 which had commenced in the fourth quarter of 2021.

We had increases in stock compensation and consulting

fees of $4,000 from $321,000 in 2021 to $325,000 in 2022, decreases in engineering of $4,000 from $169,000 in 2021 to $165,000 2022

and decreases in other R&D costs of $119,000 from $331,000 in 2021 to $212,000 in 2022.

The aforementioned changes were offset by

the decrease in the Safegard operating cost of $275,000 from $850,000 in 2021 to $575,000 in 2022, incurred prior to acquisition.

operating costs primarily related to the use of Safegard’s workforce, utility costs incurred and other services.

The facility,

since June 2020 and following the acquisition, has been used for further development, production of current prototype samples and related

The decrease of $675,386 was due to decreased R&D costs incurred at the Safegard facility which

transitioned principally from R&D activities to manufacturing.

The decrease occurred in materials and general operating costs of approximately

$1M, of which, a) $575,000 related to cost incurred prior to the acquisition in July 2022 for utilization of the facility, which included

Safegard’s workforce and facility operating cost and b) decreases in material and other operating of $426,000 from $545,000 in

2022 to $119,000 in 2023.

Further, we had decreases in labor related costs of $224,000 specifically related to decreases in stock compensation

of $83,000 from $97,000 in 2022 to $14,000 in 2023, decreases in engineering and other labor costs of $141,000 from $492,000 in 2022

to $351,000 in 2023 and other decreases of $10,000.

The overall decrease was partially offset by $560,000 charge in 2023 for an impairment

of certain molds.

and Administrative

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The increase of $2,063,243 was primarily attributable to increases in payroll and related of:

payroll and consulting fees of $805,000 from $918,000 in 2021 to $1,723,000 in 2022, primarily due to increased amounts of payroll and

increased staffing, including fifty-two staff members and $187,000 relating to the Safegard acquisition from date of acquisition and

additional other staff and pay of $618,000 from $918,000 in 2021 to $1,355,000 in 2022 and ii) decrease in stock compensation expense,

due to timing of option awards and vesting, of approximately $175,000 from $1,091,000 in 2021 to $916,000 in 2022.

In addition, we had

increases in G&A in the year ended December 31, 2022 of approximately $3,021,000 principally from increased:

marketing and promotion

($878,000), professional fees ($178,000), travel ($152,000), board fees ($151,000), insurance ($521,000).

public company and investor

relations related ($294,000), issuance costs related to the warrants ($550,000), rent and office expenses ($109,000) and other ($188,000).

payroll and consulting fees of $1,530,000 from $1,630,000 in 2022 to $3,160,000 in 2023, primarily due to increased amounts of payroll,

increased staffing and higher usage of various consulting services and ii) increase in stock compensation expense, due to timing of option

awards and vesting, of approximately $34,000 from $916,000 in 2022 to $950,000 in 2023.

In addition, we had increases in G&A for

the year ended December 31, 2023, of approximately $498,000 principally from increased:

professional fees $318,000, depreciation $238,000,

general operating costs $251,000, insurance $126,000, technology related costs, including implementation of new ERP system $128,000 and

separation expense of $375,000 for former officer.

These were partially offset by lower public company costs and investor relations $818,000,

travel $90,000 and patent fees $31,000.

expense (income)

expense, net of interest income, was $ 1,320,416 for

the year ended December 31, 2022 , compared to interest expense of $ 166,746 for

the year ended December 31, 2021 .

Interest expense increased by $ 1,153,670 due

to the financing entered into in December 2021 which resulted in interest payable at the 8% face amount of $47,111 plus accreted interest

of $1,299,985 on the $2,000,000 Note Payable which was repaid at the IPO closing with net proceeds.

income, net of interest expense, was $138,118 for the year ended December 31, 2023, compared to interest expense of $1,320,416 for the

year ended December 31, 2022.

Interest improved, net by $1,458,534 due to a) interest earned on invested cash in 2023 of $138,118 as

compared to $42,900 in 2022 and b) the decrease in interest expense and accreted interest of approximately $1,363,316 was primarily relating

to the financing entered in December 2021which was repaid at the IPO closing with net proceeds.

Adjustment for Derivatives

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with recognition of the changes in fair value to other income or expense in the statement of operations and comprehensive loss.

year ended December 31, 2022, the Company recorded a $5,392,911 FMV gain to reflect the decrease in the Note Warrants and Warrants liabilities

issued with the IPO.

years ended December 31, 2023, and 2022 the Company recorded a $169,583 and $5,392,911 FMV gain adjustment respectively to reflect the

decrease in the Note Warrants and Warrants liabilities issued.

(See Notes 7, 8 and 10 to the Consolidated Financial Statements)

and Capital Resources

April 13, 2022, we completed its IPO which was declared effective by the SEC, and the Company’s common stock and warrants

began trading on the Nasdaq Capital Market or Nasdaq on April 14, 2022 and which closed on April 19, 2022.

The net proceeds from the

IPO were approximately $14.2 million of which $5,778,750 was attributed to the warrant liability (See Notes 8 and 10 to the Consolidated Financial Statements) .

December 31, 2023, and 2022, we had a cash balance of $3,012,908 and $4,170,897, respectively.

The Company has working capital of $1,145,569

as of December 31, 2022 vs working capital deficiency of $1,156,998, as of December 31, 2021.

The increase in our working capital was

primarily related to net proceeds from our initial public offering of approximately $14.2 million prior to the effect of recording the

liability attributed to the warrants from the IPO, less use of cash in operations, investing in fixed assets purchased, repayment of

the Note Payable of $2.0 million and $2.4 million paid relating to the Safegard acquisition.

On February 3, 2023, we completed a securities purchase agreement (“Offering”) with institutional investors and received net

proceeds from the Offering were approximately $3.2 million, net of $600,000 in fees relating to the placement agent and other offering

The Offering was priced at the market under Nasdaq rules.

In connection with the Offering, we issued 2,248,521 units at

a purchase price of $1.69 per unit.

Each unit consists of one share of common stock and one non-tradable warrant exercisable for one share

of common stock at a price of $1.56.

The warrants have a term of five years from the issuance date.

(See Notes 16 to the Consolidated Financial Statements)

as of December 31, 2023, vs working capital of $2,416,928, as of December 31, 2022.

The decrease in our working capital, after net proceeds from offerings of $8,029,628, was primarily

related to the use of cash of $9,205,577 in operations and investing in fixed assets purchased.

The Company intends to finance its future development and commercialization activities and its working capital needs

largely from the sale of equity securities and/or with additional funding from other traditional financing sources.

April 13, 2022, we completed its IPO which was declared effective by the SEC, and the Company’s common stock and warrants began

trading on the Nasdaq Capital Market or Nasdaq on April 14, 2022 and which closed on April 19, 2022.

The net proceeds from the IPO were

approximately $14.2 million of which $5,778,750 was attributed to the warrant liability (See Notes 8 and 10 to the Consolidated Financial

February 3, 2023, we completed a securities purchase agreement) - (See Recent Developments-Offering).

On September 29, 2023, the Company

completed two simultaneous offerings (See Recent Developments – Shelf Offering and Private Placement Offering)

Cash Used in Operating Activities

Company used cash of $8,507,300 and $6,433,159 in operating activities for the year ended December 31, 2023 and 2022, respectively.

increase in cash used was principally due to the Company incurring additional G&A expenses and R&D activities as described above

increase in cash used was principally due to the Company incurring additional G&A expenses, buildup of inventory partially offset by lower R&D activities as described above

during year ended December 31, 2022.

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the year ended December 31, 2023 and 2022, the Company used cash in investing activities of $698,277 and $3,117,916, respectively.

In both years, cash was used to acquire or pay deposits for machinery and equipment of $542,662 and $2,221,830, respectively.

Further, in the year ended December 31, 2022 and 2021, the Company used $2,365,576 and $75,000, respectively the acquisition of

Safegard or related escrow payments.

both years, cash was used to acquire or pay deposits for machinery and equipment of $698,277 and $542,662, respectively.

ended December 31, 2022, the Company used $2,365,576, for the acquisition of Safegard or related escrow payments.

Cash Provided by Financing Activities

the year ended December 31, 2023 and 2022, the Company provided cash from financing activities of $8,029,628 and $12,235,475 respectively.

In the 2022 period, the cash provided was primarily from the IPO net proceeds of $14,202,975, prior to the effect of recording the liability

attributed to the warrants from the IPO, less the Notes repayment of $2,000,000.

In 2021, the cash provided was from stock subscriptions

from a private placement.

In the 2023 period, the cash provided was from the net proceeds from the Offerings in February and September 2023.

In the 2022 period,

the cash provided was primarily from the IPO net proceeds of $14,202,975, prior to the effect of recording the liability attributed to

the warrants from the IPO, less the Notes repayment of $2,000,000.

Sheet Arrangements

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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 7. Management’s Discussion and Analysis