You are currently viewing MIROMATRIX MEDICAL INC.  Management’s Discussion and Analysis of Financial Condition and Results of Operations (Form 10-Q)

MIROMATRIX MEDICAL INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations (Form 10-Q)

References in this report (the "Quarterly Report") to "we," "us," "our" or the
"Company" refer to Miromatrix Medical Inc. The following discussion and analysis
of the Company's financial condition and results of operations should be read in
conjunction with the condensed financial statements and the notes thereto
contained elsewhere in this Quarterly Report. Information contained in the
discussion and analysis set forth below includes forward-looking statements that
involve risks and uncertainties.

Special note regarding forward-looking statements


This Quarterly Report includes "forward-looking statements" within the meaning
of Section 27A of the Securities Act of 1933, as amended (the "Securities Act")
and Section 21E of the Securities Exchange Act of 1934, as amended (the
"Exchange Act") that are not historical facts and involve risks and
uncertainties that could cause actual results to differ materially from those
expected and projected. All statements, other than statements of historical fact
included in this report including, without limitation, statements in this
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" the Company's financial position, business strategy and the plans
and objectives of management for future operations, are forward-looking
statements. Words such as "expect," "believe," "anticipate," "intend,"
"estimate," "seek" and variations and similar words and expressions are intended
to identify such forward-looking statements. Such forward-looking statements
relate to future events or future performance, but reflect management's current
beliefs, based on information currently available. A number of factors could
cause actual events, performance or results to differ materially from the
events, performance and results discussed in the forward-looking statements. For
information identifying important factors that could cause actual results to
differ materially from those anticipated in the forward-looking statements,
please refer to the Risk Factors section of the Company's Annual Report on
  Form 10-K   for the fiscal year ended December 31, 2021 filed with the U.S.
Securities and Exchange Commission ("SEC"). The Company's securities filings can
be accessed on the EDGAR section of the SEC's website at www.sec.gov. Except as
expressly required by applicable securities law, the Company disclaims any
intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.

Insight


We are a life sciences company pioneering a novel technology for bioengineering
fully transplantable organs to help save and improve patients' lives. Founded in
2009, we are one of a small group of companies at the forefront of developing
alternatives to human-donor organ transplants, and within this small group of
companies there are important differences between the technologies being
developed. Our proprietary technology is a scalable platform that uses a
two-step method of decellularization and recellularization designed to remove
the porcine cells from the organs obtained from pigs and replace them with
unmodified human cells. Our initial development focus is on bioengineering
livers and kidneys, and our technology platform is also applicable to
bioengineering other organs including hearts, lungs and pancreases. We have
collaborations with the Mayo Clinic, Mount Sinai and the Texas Heart Institute,
and have received strategic investments from Baxter, CareDx and DaVita.

Components of our operating results

Licensing revenue

For the periods presented, all of our revenue consists of licensing revenue
pursuant to our license agreement with Reprise Biomedical, Inc. ("Reprise").
Revenue pursuant to this agreement is recognized at the later of (i) when the
related sales occur after the minimum guarantee is satisfied, or (ii) when the
performance obligation to which some or all of the royalty has been allocated
has been satisfied (or partially satisfied). Due to the uncertainty regarding
the collectability of these minimum royalties from Reprise, the Company has set
up an allowance to offset the entire remaining minimum royalty receivable
amount.

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Cost of Goods Sold

The cost of goods sold is related to our license agreement with the University of Minnesota (the “University”), under which we owe the University royalties on our revenues, which are subject to annual minimum payments.

Research and development costs

Research and development expenses primarily include engineering, product development, consulting services, materials, depreciation and other costs associated with products and technologies under development. These expenses include payroll and similar expenses, consultation fees, laboratory supplies and amounts committed under certain collaboration agreements. Expenditures related to research and development activities are charged to earnings as incurred.

We expect research and development expenses in absolute dollars to increase in
the future as we develop our product candidates. We expect research and
development expenses as a percentage of revenue to vary over time depending on
the level and timing of new product development initiatives.

Regulatory and clinical expenses


Regulatory and clinical expenses include costs for developing our regulatory and
clinical study strategies for our product candidates. These expenses include
payroll and related expenses and consulting expenses.

Over time we expect our regulatory and clinical expenses to increase in absolute
dollars as we develop our product candidates and move through various regulatory
processes. We expect our regulatory and clinical expenses to decrease as a
percentage of revenue primarily as, and to the extent, our revenue grows.

Quality spending


Quality expenses relate to costs of systems and procedures to develop a
manufacturing facility that is compliant with Current Good Manufacturing
Practices. These expenses include payroll and related expenses. We expect our
quality expenses in absolute dollars to increase in future years as we continue
to develop the process and systems needed to produce our product candidates.

General and administrative expenses


General and administrative expenses include costs for our executive, accounting,
and human resources functions. Costs consist primarily of payroll and related
expenses, professional service fees related to accounting, legal, insurance and
other contract and administrative services and related infrastructure expenses.

We expect our general and administrative expenses in absolute dollars to increase as we increase our workforce to support our growth.

interest income

Interest income includes interest earned on our cash and cash equivalents and
WE Treasury securities.


Interest Expense

Interest expense includes interest under our loan agreements. See “- Liquidity and Capital Resources”.

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Results of Operations

Three Months Ended June 30, 2022 Compared with Three Months Ended June 30, 2021

                                             Three Months Ended
                                                 June 30,                           Change
                                           2022             2021            Dollar         Percentage
Licensing revenue                      $       3,952    $       9,139    $     (5,187)       (56.8) %
Cost of goods sold                           125,000          125,000                -            -
Gross loss                                 (121,048)        (115,861)          (5,187)          4.5
Operating expenses:
Research and development                   4,988,233        2,480,887        2,507,346        101.1
Regulatory and clinical                      419,394          103,256          316,138        306.2
Quality                                      517,333           86,257          431,076        499.8
General and administrative                 2,188,460          786,322        1,402,138        178.3
Total operating expenses                   8,113,420        3,456,722        4,656,698        134.7
Operating loss                           (8,234,468)      (3,572,583)      (4,661,885)        130.5
Interest income                               61,078               45           61,033    135,628.9
Interest expense                             (8,799)        (280,663)          271,864       (96.9)
Amortization of discount on note                   -         (30,052)           30,052      (100.0)
Change in fair value of derivative                 -           52,991      
  (52,991)      (100.0)
Research grants                                    -          127,428        (127,428)      (100.0)
Net loss                               $ (8,182,189)    $ (3,702,834)    $ (4,479,355)        121.0 %


Licensing Revenue

Licensing revenue was $3,952 for the three months ended June 30, 2022 and $9,139
for the three months ended June 30, 2021, a decrease of $5,187, or 56.8%. The
licensing revenue is a result of the license agreement with Reprise. The
remainder of minimum royalties due from Reprise for 2020 and 2021 have been
deferred to 2022 and 2023, respectively. The remainder of minimum royalties due
from Reprise for 2022 are due in January 2023. Due to the uncertainty regarding
the collectability of these minimum royalties from Reprise, the Company has set
up an allowance to offset the entire remaining minimum royalty receivable
amount.

Cost of Goods Sold

The cost of goods sold was $125,000 for the two months ended June 30, 2022
and 2021. Cost of goods sold relates to the minimum royalty due to the University under our license agreement.

Research and development


Research and development expenses were $4,988,233 for the three months ended
June 30, 2022 and $2,480,887 for the three months ended June 30, 2021, an
increase of $2,507,346, or 101.1%. The increase was primarily due to a lab
supply increase of $1,154,178, headcount increase which resulted in an increase
in payroll expenses of $514,899, contract pre-clinical cost increase of $331,207
and consulting expense increase of $321,820.

Regulatory and clinical


Regulatory and clinical expenses were $419,394 for the three months ended
June 30, 2022 and $103,256 for the three months ended June 30, 2021, an increase
of $316,138, or 306.2%. The increase was primarily due to a headcount increase
which resulted in an increase in payroll expenses of $191,822, as well as an
increase of $66,476 in regulatory consulting and contracting expense.

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Quality
Quality expenses were $517,333 for the three months ended June 30, 2022 and
$86,257 for the three months ended June 30, 2021, an increase of $431,076, or
499.8%. The increase was primarily due to a headcount increase which resulted in
an increase in payroll expenses of $190,531, lab supplies increase of $123,297
and consulting expense increase of $81,467.

General and administrative


General and administrative expenses were $2,188,460 for the three months ended
June 30, 2022 and $786,322 for the three months ended June 30, 2021, an increase
of $1,402,138, or 178.3%. The increase was primarily due to a headcount increase
which resulted in an increase in payroll expenses of $670,081, insurance expense
increase of $276,623, office expense increase of $190,538, depreciation expense
increase of $149,594 and consulting expense increase of $40,759. These increases
can primarily be attributed to the cost of being a public company.

interest income


Interest income was $61,078 for the three months ended June 30, 2022 and $45 for
the three months ended June 30, 2021, an increase of $61,033. The increase was
primarily due to U.S. Treasury securities purchased during the second quarter of
2022 with cash received from our initial public offering ("IPO").

Interest charges


Interest expense was $8,799 for the three months ended June 30, 2022 and
$280,663 for the three months ended June 30, 2021, a decrease of $271,864, or
96.9%. The decrease was primarily due to the $6,000,000 convertible promissory
note issued to Cheshire MD Holdings, LLC (the "Cheshire Note") being converted
to equity in June 2021, and therefore there was no interest expense related to
the Cheshire Note in 2022 compared to 2021.

Amortization of ticket discount


Amortization expense related to the Cheshire Note was $0 for the three months
ended June 30, 2022 and $30,052 for the three months ended June 30, 2021. The
decrease was due to the Cheshire Note being converted to equity in June 2021,
and therefore there was no amortization expense related to the Cheshire Note in
2022 compared to 2021.

Change in fair value of derivative

The fair value of the embedded derivative related to the Cheshire Note was $0
for the three months ended June 30, 2022 and $52,991 for the three months ended
June 30, 2021. The decrease in the change in fair value of the embedded
derivative was due to the Cheshire Note being converted to equity in June 2021.

Fellowship


Research grants were $0 for the three months ended June 30, 2022 and $127,428
for the three months ended June 30, 2021. The decrease in research grants was
primarily due to decreases in pre-clinical contracting, resulting in lower
grant
funds.

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Semester completed June 30, 2022 Compared to the half-years ended June 30, 2021

                                              Six Months Ended
                                                  June 30,                           Change
                                            2022             2021             Dollar        Percentage
Licensing revenue                      $       10,720    $      15,247    $      (4,527)      (29.7) %
Cost of goods sold                            250,000          250,000                 -           -
Gross loss                                  (239,280)        (234,753)           (4,527)         1.9
Operating expenses:
Research and development                    8,994,141        4,348,888         4,645,253       106.8
Regulatory and clinical                       774,632          186,961           587,671       314.3
Quality                                       958,268          172,044           786,224       457.0
General and administrative                  4,461,775        1,349,196         3,112,579       230.7
Total operating expenses                   15,188,816        6,057,089         9,131,727       150.8
Operating loss                           (15,428,096)      (6,291,842)       (9,136,254)       145.2
Interest income                                61,848               85            61,763    72,662.4
Interest expense                             (19,690)        (586,037)           566,347      (96.6)
Amortization of discount on note                    -         (62,638)            62,638     (100.0)
Change in fair value of derivative                  -          246,962     
   (246,962)     (100.0)
Research grants                                     -          277,965         (277,965)     (100.0)
Equity loss in affiliate                            -        (223,633)           223,633     (100.0)
Gain on sale of equity investment                   -        1,983,912     
 (1,983,912)     (100.0)
Gain on debt extinguishment                         -          518,050         (518,050)     (100.0)
Net loss                               $ (15,385,938)    $ (4,137,176)    $ (11,248,762)       271.9 %


Licensing Revenue

Licensing revenue was $10,720 for the six months ended June 30, 2022 and $15,247
for the six months ended June 30, 2021, a decrease of $4,527, or 29.7%. The
licensing revenue is a result of the licensing agreement with Reprise. The
remainder of minimum royalties due from Reprise for 2020 and 2021 have been
deferred to 2022 and 2023, respectively. The remainder of minimum royalties due
from Reprise for 2022 are due in January 2023. Due to the uncertainty regarding
the collectability of these minimum royalties from Reprise, the Company has set
up an allowance to offset the entire remaining minimum royalty receivable
amount.

Cost of Goods Sold

Cost of goods sold was $250,000 for both the six months ended June 30, 2022 and
2021. Cost of goods sold relates to the minimum royalty due to the University
under our license agreement.

Research and Development
Research and development expenses were $8,994,141 for the six months ended
June 30, 2022 and $4,348,888 for the six months ended June 30, 2021, an increase
of $4,645,253, or 106.8%. The increase was primarily due to lab supplies
increase of $2,152,553, headcount increase which resulted in an increase in
payroll expenses of $1,213,414, contract pre-clinical cost increase of $632,495,
consulting expense increase of $377,826 and depreciation expense increase of
$180,645.

Regulatory and Clinical

Regulatory and clinical expenses were $774,632 for the six months ended
June 30, 2022 and $186,961 for the six months ended June 30, 2021, an increase
of $587,671, or 314.3%. The increase was primarily due to a headcount increase
which resulted in an increase in payroll expenses of $375,791, as well as an
increase in regulatory consulting and contracting expense of $149,215.

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Quality

Quality expenses were $958,268 for the six months ended June 30, 2022 and
$172,044 for the six months ended June 30, 2021, an increase of $786,224, or
457.0%. The increase was primarily due to a headcount increase which resulted in
an increase in payroll expenses of $399,756, lab supplies increase of $190,847
and consulting expense increase of $149,317.

General and administrative


General and administrative expenses were $4,461,775 for the six months ended
June 30, 2022 and $1,349,196 for the six months ended June 30, 2021, an increase
of $3,112,579, or 230.7%. The increase was primarily due to a headcount increase
which resulted in an increase in payroll expenses of $1,378,467, insurance
expense increase of $576,081, office expense increase of $349,382, depreciation
expense increase of $296,688, legal and accounting expense increase of $148,258,
other expense increase of $104,528 and consulting expense increase of $91,025.
These increases can primarily be attributed to the cost of being a public
company.

interest income

Interest income was $61,848 for the six months ended June 30, 2022 and $85 for
the six months ended June 30, 2021, an increase of $61,763. The increase was
primarily due to U.S. Treasury securities purchased during the second quarter of
2022 with cash received from the IPO.

Interest charges


Interest expense was $19,690 for the six months ended June 30, 2022 and $586,037
for the six months ended June 30, 2021, a decrease of $566,347, or 96.6%. The
decrease was primarily due to the interest expense on the $6,000,000 Cheshire
Note being converted to equity in June 2021, and therefore there was no interest
expense related to the Cheshire Note in 2022 compared to 2021.

Amortization of ticket discount

Amortization expense related to the Cheshire Note was $0 for the six months
ended June 30, 2022 and $62,638 for the six months ended June 30, 2021. The
decrease was due to the Cheshire Note being converted to equity in June 2021,
and therefore there was no amortization expense related to the Cheshire Note in
2022 compared to 2021.

Change in fair value of derivative

The fair value of the embedded derivative related to the Cheshire Note was $0
for the six months ended June 30, 2022 and $246,962 for the six months ended
June 30, 2021. The decrease in the change in fair value of the embedded
derivative was due to the Cheshire Note being converted to equity in June 2021.

Fellowship

Research grants were $0 for the six months ended June 30, 2022 and $277,965 for
the six months ended June 30, 2021. The decrease in research grants was
primarily due to decreases in pre-clinical contracting, resulting in lower grant
funds.

Loss of equity in affiliation

Equity loss in affiliate was $0 for the six months ended June 30, 2022 and
$223,633 for the six months ended June 30, 2021. The Company sold its remaining
ownership interest in Reprise in March 2021, eliminating the need to record any
such losses for future periods, including the six months ended June 30, 2022.

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gain on sale of A fair investment

The Company recorded a gain of $1,983,912 related to the sale of its remaining 1,800,000 Takeover shares March 2021.

Gain on extinguishment of debt

The Company recognized a gain on the extinguishment of debt of $518,050 for the
six months ended June 30, 2021 related to the forgiveness of our loan under the
Small Business Administration's Paycheck Protection Program.

Cash and capital resources

We have incurred net losses since our inception. For the three months ended
June 30, 2022 and 2021, we incurred net losses of $8,182,189 and $3,702,834,
respectively. For the six months ended June 30, 2022 and 2021, we incurred net
losses of $15,385,938 and $4,137,176, respectively. As of June 30, 2022, we had
an accumulated deficit of $89,437,852.

We expect to incur additional losses in the near future, and we expect our
expenses to increase substantially in connection with our ongoing activities,
particularly as we continue to develop our bioengineered organs, as we conduct
clinical trials and other studies for our bioengineered organs, seek regulatory
clearances or approvals for Miroliver and Mirokidney, continue preparing, filing
and prosecuting patent applications, maintaining and enforcing our intellectual
property rights and to invest in our infrastructure to support our future
manufacturing and other activities. We expect to incur additional costs
associated with operating as a public company in the United States. The timing
and amount of our operating expenditures will depend largely on our ability to,
among other things:

? advance the clinical development of our product candidates;

manufacture, or have manufactured on our behalf, our preclinical and clinical products

? materials and develop processes for the commercial manufacture of any product

applicants likely to receive regulatory approval;

? seek regulatory approvals for any successful product candidates

clinical tests;

establish a sales, marketing, medical affairs and distribution infrastructure

? to commercialize any product candidates for which we may obtain commercialization

approval and intent to market by us;

? establish collaborations to commercialize any product candidates for which we

may obtain marketing authorization but do not intend to market ourselves;

developing our operational, financial and management systems and hiring

personnel, including personnel to support our clinical development, quality

? control, research and development, manufacturing and marketing efforts,

our general and administrative activities and our operations as a public

company; and

? obtain new intellectual property and maintain, develop and protect our

intellectual property portfolio.

Sources of liquidity

To date, we have primarily financed our operations through equity and debt
financings, as well as research grants and our IPO. We believe that our existing
cash and cash equivalents will enable us to fund our operating expenses and
capital expenditure requirements through 2023. As of June 30, 2022, we had cash
and cash equivalents of $12,593,315, short-term investments of $20,080,428 and
long-term investments of $5,938,693. We have based this estimate on assumptions
that may prove to be wrong, and we could use our available capital resources
sooner than we currently expect.

Until such time, if ever, as we can generate substantial revenue from sales of
our bioengineered organs, we expect to finance our cash needs through a
combination of equity offerings and debt financings. To the extent that we raise
additional capital through the sale of equity or convertible debt securities,
the ownership interest of our stockholders will be diluted, and the terms of
these securities may include liquidation or other preferences that adversely
affect the rights of our stockholders. Debt financing and preferred equity
financing, if available, may involve agreements that include covenants limiting
or restricting our ability to take specific actions, such as incurring
additional debt, making capital expenditures or declaring dividends. Additional
capital may not be available when needed, on reasonable terms, or at all, and
our ability to raise additional capital may be adversely impacted by potential
worsening global economic conditions. If we are unable

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to raise additional funds through equity or debt financings or other
arrangements when needed, we may be required to delay, curtail or discontinue
our product development or future commercialization efforts, or grant rights to
develop and market products that we would otherwise prefer to develop and market
ourselves.

Debt Financing

In January 2012, we signed a promissory note with the University for $405,559.
The promissory note bears interest at 3% per annum, compounded monthly. The note
is scheduled to mature on December 31, 2022 and is unsecured. We are required to
make monthly principal and interest payments of $7,737 until the note is paid in
full. In connection with the promissory note, we issued the University warrants
to purchase 80,000 shares of our common stock at an exercise price of $1.69. As
of June 30, 2022 and December 31, 2021, the principal outstanding on this loan
was $38,399 and $83,849, respectively.

In May 2015, we entered into a loan agreement with the Minnesota Department of
Employment & Economic Development under which we borrowed $250,000. The loan was
unsecured and did not bear interest. The loan was due in a lump sum payment on
April 1, 2022. As of June 30, 2022 and December 31, 2021, the balance
outstanding on this loan was $0 and $250,000.

In January 2019, we issued the University a promissory note in the amount of
$385,997 in satisfaction of our minimum royalty obligation under the license
agreement with the University for the year ended December 31, 2018. The note
bears interest at 6% per annum, compounded annually, and is due on January 31,
2025. In addition, we issued the University a 10-year warrant to purchase 20,587
shares of our common stock at an exercise price of $3.75 per share. As of both
June 30, 2022 and December 31, 2021, the principal outstanding on this loan
was
$385,997.

Initial Public Offering

In June 2021, we completed our IPO through which we issued and sold 5,520,000
shares of common stock at $9.00 per share. In connection with the IPO, we raised
$44,528,060, after deducting the underwriting discount and offering expenses
payable by us.

Equity Distribution Agreement

On July 1, 2022, we entered into an Equity Distribution Agreement with Piper
Sandler & Co. ("Piper Sandler"). The Equity Distribution Agreement provides
that, upon the terms and subject to the conditions set forth therein, we may
issue and sell through Piper Sandler, acting as the sales agent, shares of our
common stock having an aggregate offering price of up to $50.0 million. We have
no obligation to sell any such shares under the Equity Distribution Agreement.
The sale of the shares of our common stock by Piper Sandler, if any, will be
effected pursuant to a Registration Statement on Form S-3, filed with the SEC on
July 1, 2022 and declared effective on July 11, 2022 (the "Registration
Statement"). We did not issue any shares under the Equity Distribution Agreement
in the six months ended June 30, 2022.

Registration statement

We filed the Registration Statement with the SEC on July 1, 2022 which was
declared effective on July 11, 2022. The Registration Statement registered the
offer and sale of an indeterminate number of shares of common stock and
preferred stock, an indeterminate principal amount of debt securities and an
indeterminate number of warrants to purchase common stock, preferred stock, and
various series of debt securities and/or warrants to purchase any of such
securities, having an aggregate initial offering price of $200.0 million.

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Cash Flows

The following table summarizes our sources and uses of cash for each of the
periods presented:

                                                                    Six Months Ended
                                                                        June 30,
                                                                  2022             2021
Net cash (used in) provided by:
Operating activities                                         $ (13,790,978)    $ (5,390,815)
Investing activities                                           (26,757,741)        1,913,888
Financing activities                                                330,503       65,558,289

(Decrease) net increase in cash and cash equivalents $(40,218,216)

   $  62,081,362


Operating Activities

Net cash used in operating activities consisted of net losses adjusted for certain non-cash items and changes in operating assets and liabilities.


During the six months ended June 30, 2022, net cash used in operating activities
was $13,790,978 and reflected (i) the net loss of $15,385,938, (ii) net non-cash
usage items of $1,027,437, including $600,371 of stock-based compensation,
$536,507 of depreciation and amortization expense, amortization of
premium/discount on investments of $6,734 and $758 of loss on disposal of
property and equipment, partially offset by non-cash interest income of
$116,933, and (iii) a net cash outflow from changes in balances of operating
assets and liabilities of $567,523.

During the six months ended June 30, 2021, net cash used in operating activities
was $5,390,815 and reflected (i) the net loss of $4,137,176, (ii) net non-cash
items of $2,164,149, including a gain on sale of equity investment of
$1,983,912, paycheck protection program loan forgiveness of $518,050, and the
change in fair value of embedded derivative of $246,962, partially offset by
stock-based compensation of $239,330, an equity loss in affiliate of $223,633,
amortization of discount on note of $62,638 and depreciation and amortization
expense of $59,174 and (iii) a net cash inflow from changes in balances of
operating assets and liabilities of $910,510.

Investing activities

In the six months ended June 30, 2022the net cash used by investing activities was $26,757,741 and reflects the purchase of investments from $26,026,125 and purchases of property, plant and equipment of $731,616.

In the six months ended June 30, 2021net cash from investing activities was $1,913,888 and reflects the proceeds from the sale of shares Reprise de $2,000,000offset by purchases of property, plant and equipment of $86,112.

Fundraising activities

In the six months ended June 30, 2022net cash provided by financing activities was $330,503 and resulted primarily from proceeds from the exercise of stock warrants of $414,098 and the proceeds from the exercise of stock options of
$256,883; partially offset by payments on the long-term debt of $295,450payments on the finance lease obligations of $26,488 and payments on the offering fee of
$18,540.


During the six months ended June 30, 2021, net cash provided by financing
activities was $65,558,289 and was primarily the result of net proceeds from the
IPO of $45,679,111, net proceeds from sales of Series C Preferred Stock of
$19,891,670 and proceeds related to stock option and warrant exercises of
$40,875, partially offset by payments on long-term debt of $44,109 and payments
on financing lease obligations of $9,258.

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