OMEGA THERAPEUTICS, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

You should read the following discussion and analysis of our financial condition
and results of operations together with our unaudited financial statements and
related notes appearing elsewhere in this Quarterly Report on Form 10-Q, or
Quarterly Report, and our Annual Report on Form 10-K for the year ended December
31, 2021 filed with the United States Securities and Exchange Commission, or
SEC, on March 10, 2022 (the "2021 10-K"). Some of the information contained in
this discussion and analysis or set forth elsewhere in this Quarterly Report,
including information with respect to our plans and strategy for our business
and related financing, includes forward-looking statements that involve risks
and uncertainties. As a result of many factors, including those factors set
forth in the "Risk Factors" section of this Quarterly Report, our actual results
could differ materially from the results described in or implied by the
forward-looking statements contained in the following discussion and analysis.
Please also see the "Special Note Regarding Forward-Looking Statements" section
of this Quarterly Report.

                                    Overview

Omega Therapeutics is pioneering a systematic approach to use mRNA therapeutics
as programmable epigenetic medicines by leveraging our OMEGA Epigenomic
Programming platform ("OMEGA platform"). mRNA refers to Messenger RNA, a
single-stranded RNA (ribonucleic acid that carries instructions for the
synthesis of proteins) corresponding to the sequence of a gene. Our OMEGA
platform harnesses the power of epigenetics, the mechanism that controls gene
expression and every aspect of an organism's life from cell genesis, growth and
differentiation to cell death. We have deciphered the three-dimensional
architecture of the human genome. Genes and their accompanying regulators are
organized into distinct and evolutionarily conserved structures called Insulated
Genomic Domains, or IGDs. IGDs are the fundamental structural and functional
units of gene control and cell differentiation and act as the "control room" of
biology. Most diseases are caused by aberrant gene expression rooted in
alterations in IGDs. The OMEGA platform has enabled us to systematically
identify and validate thousands of novel DNA-sequence-based epigenomic "zip
codes" associated with individual regulatory elements within IGDs. We call these
epigenomic targets EpiZips. We rationally design and engineer our mRNA
therapeutics, which are programmable and modular epigenetic medicines, called
Omega Epigenomic Controllers, or OECs, to target EpiZips for Precision Genomic
Control. This enables us to precisely tune genes to a desired level of
expression and to control the duration of expression. Through this approach, we
believe that the OMEGA platform has broad potential applicability across a range
of diseases and conditions. Our pipeline currently consists of early-stage,
preclinical programs that span oncology, multigenic diseases including
immunology, regenerative medicine, and select monogenic diseases. We have
conducted in vivo preclinical studies of our OECs in multiple disease models for
various indications, including hepatocellular carcinoma, or HCC, non-small cell
lung cancer, or NSCLC, and acute respiratory distress syndrome, or ARDS, and we
expect to conduct in vivo preclinical studies for multiple additional programs.
We initiated investigational new drug application ("IND") enabling studies for
multiple programs in 2021, and we are aiming to submit an IND for our OEC
candidate for the treatment of HCC and declare two OEC development candidates in
the middle of 2022. We are also planning to submit an IND for another OEC
candidate in the second half of 2022 or early 2023.

Since our inception, we have incurred significant operating losses. We have not
commercialized any products and have never generated any revenue from product
sales. We have devoted almost all of our financial resources to research and
development, including our preclinical development activities and preparing for
clinical trials of our product candidates. To date, we have funded our
operations primarily with proceeds from sales of equity securities and
borrowings under our loan and security agreement.

As of March 31, 2022, we had cash, cash equivalents and marketable securities of
$200.8 million. In August 2021, we completed our initial public offering ("IPO")
pursuant to which we issued and sold 8,300,976 shares of our common stock,
including 900,976 shares pursuant to the partial exercise of the underwriters'
option to purchase additional shares, at a public offering price of $17.00 per
share, for aggregate gross proceeds of $141.1 million. We received approximately
$128.1 million in net proceeds after deducting underwriting discounts and
commissions and other offering expenses payable by us.

Our ability to generate product revenue will depend on the successful
development, regulatory approval, and eventual commercialization of one or more
of our product candidates. Until such time, if ever, as we can generate
substantial product revenue, we expect to finance our operations through equity
offerings, debt financings, marketing and distribution arrangements and other
collaborations, strategic alliances and licensing arrangements, or other
sources. Additional sources of financing might not be available to us on
favorable terms, if at all. If we are unable to raise additional funds through
equity or debt financings when needed, we may be required to delay, limit,
reduce, or terminate our product

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development or future commercialization efforts or grant rights to develop and
market product candidates that we would otherwise prefer to develop and market
ourselves.

We expect to continue to incur significant additional operating losses for the
foreseeable future as we seek to advance product candidates through clinical
development, continue preclinical development, expand our research and
development activities, develop new product candidates, complete preclinical
studies and clinical trials, seek regulatory approval and, if we receive
regulatory approval, commercialize our products. Our expenses will also increase
substantially if or as we:

• continue our research and development efforts and submit INDs for our product
candidates;

• initiate and conduct clinical trials of our product candidates;

• continue to engineer and develop additional product candidates;

• continue to develop the OMEGA platform;

• seek regulatory and marketing approvals for product candidates that
successfully complete clinical trials, if any;

• establish manufacturing and supply chain capacity sufficient to provide
clinical and, if applicable, commercial quantities of product candidates,
including building our own manufacturing facility;


• establish a sales, marketing, internal systems and distribution infrastructure
to commercialize any products for which we may obtain regulatory approval, if
any, in geographies in which we plan to commercialize our products ourselves;

• maintain, expand, protect and enforce our intellectual property estate;

• hire additional staff, including clinical, scientific, technical, regulatory,
operational, financial, commercial, and support personnel, to execute our
business plan and support our product development and potential future
commercialization efforts;

• enter into collaborations or licenses for new technologies;

• make royalty, milestone, or other payments under our current and any future
in-license agreements;

• incur additional legal, accounting, and other expenses in operating our
business; and

• continue to operate as a public company.

                       Impact of COVID-19 on our business

The worldwide COVID-19 pandemic, including the identification of new variants of
the virus, may affect our ability to initiate and complete preclinical studies,
delay the initiation of our future clinical trials, or have other adverse
effects on our business, results of operations, financial condition, and
prospects. In addition, the pandemic has caused substantial disruption in the
financial markets and may adversely impact economies worldwide, both of which
could adversely affect our business, operations and ability to raise funds to
support our operations.

To date, we have not experienced material business disruptions as a result of
the pandemic. We are following, and plan to continue to follow, recommendations
from federal, state and local governments regarding workplace policies,
practices and procedures. To provide a safe work environment for our employees,
we have implemented various measures to promote for social distancing, encourage
employees to work remotely when possible, increase sanitization of our
facilities and provide personal protective equipment for our employees. In
addition, the third-party contract research organizations, or CROs, and contract
development and manufacturing organizations, or CDMOs, that we engage have faced
in the past and may face in the future disruptions that could affect our ability
to initiate and complete preclinical studies, including disruptions in procuring
items that are essential for our research and development activities, such as,
for example, raw materials used in the manufacture of our product candidates and
laboratory supplies for our preclinical studies, for which there may be
shortages because of ongoing efforts to address the COVID-19 pandemic.

We cannot be certain what the overall impact of the COVID-19 pandemic, or the
variants of the virus, will be on our business, and the pandemic has the
potential to adversely affect our business, financial condition, results of
operations, and prospects.

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                    Components of our results of operations

Revenue

To date, we have not generated any revenue from product sales, and do not expect
to generate any revenue from the sale of products for the foreseeable future.
Our revenue to date has been generated through our collaboration agreement with
PM (CF) Explorations, Inc., or PMCo, an affiliate of Flagship Pioneering
("Flagship"), in which we are entitled to receive reimbursement for the costs
associated with our research activities performed.

Operating expenses

Research and development expenses

Research and development expenses consist primarily of costs incurred in
performing research and development activities, which include:

• personnel-related expenses, including salaries, bonuses, benefits, and
stock-based compensation for employees engaged in research and development
functions;


• expenses incurred in connection with the discovery and preclinical development
of our research programs, including under agreements with third parties, such as
consultants, contractors, CROs and CDMOs that manufacture material for use in
our discovery and preclinical development;

• laboratory supplies and research materials;

• costs of licensing technology; and

• facilities, depreciation, and other expenses which include direct and
allocated expenses.


We expense research and development costs as incurred. Costs for research and
development activities are recognized based on an evaluation of the progress to
completion of specific tasks. Payments for these activities are based on the
terms of the individual agreements, which may differ from the pattern of costs
incurred, and are reflected in our unaudited financial statements as prepaid or
accrued research and development expenses. Nonrefundable advance payments that
we make for goods or services to be received in the future for use in research
and development activities are recorded as prepaid expenses and expensed as the
related goods are delivered or the services are performed.

We do not track the research and development expenses on a program-by-program
basis for our product candidates, and we do not allocate costs associated with
our discovery efforts, laboratory supplies and facilities, including
depreciation or other indirect costs, to specific programs because these costs
are deployed across multiple programs and the OMEGA platform. We use internal
resources primarily to conduct our research and discovery activities as well as
for managing our preclinical development, process development, manufacturing and
clinical development activities. These employees work across multiple programs
and our technology platform and, therefore, we do not track these costs by
program.

We expect that our research and development expenses will continue to increase
as we continue our current discovery and research programs, initiate new
research programs, continue preclinical development of our product candidates
and conduct future clinical trials for any of our product candidates.

General and administrative expenses


General and administrative expenses consist primarily of salaries and other
related costs such as bonuses and benefits, including stock-based compensation,
for personnel in our executive, finance, legal, human resources, corporate
business development, and administrative functions. General and administrative
expenses also include professional fees for legal, patent, accounting,
information technology, auditing, tax, consulting services, insurance and
facility-related expenses, which include direct depreciation costs and allocated
expenses for rent and maintenance of facilities and other operating costs.

We expect that our general and administrative expenses will increase in the
future as we increase our headcount to support our continued research and
development and potential commercialization of our product candidates. We also
expect to continue to incur increased expenses associated with being a public
company, including costs of accounting, audit, legal, regulatory, and tax
compliance services, directors' and officers' liability insurance costs, and
investor and public relations costs.

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Related party expense, net


Related party expense, net consists primarily of fees paid to Flagship for their
management services provided to us, as well as reimbursements for certain
expenses, including insurance and benefits, general consulting, and software
licenses incurred on our behalf. Additionally, our principal office and
laboratory space is leased with an affiliate of Flagship, and we also sublease
our other office and laboratory space to two other parties which are affiliates
of Flagship. The rent expense and costs related to our principal office and
laboratory space, including real estate taxes, insurance, and normal maintenance
costs, are considered as related party expenses. Such related party expenses are
offset with sublease income received from our related parties, which is
comprised of base rent and costs related to the subleased premises such as real
estate taxes, cost of operations, maintenance, repair, replacement, and property
management.

Other expense, net

Interest expense, net

Interest expense, net primarily consists of interest payments as well as the
amortization of the debt discount related to our loan and security agreement.

Other expense, net


Other expense, net primarily consists of the remeasurement gains or losses
associated with changes in the fair value of the warrant liability and the
success fee obligation related to our loan and security agreement, as amended.
Until settlement, fluctuations in the fair value of our warrant liability and
success fee obligation are based on the remeasurement at each reporting period.

                             Results of operations

Comparison for the three months ended March 31, 2022 and 2021

The following table summarizes the results of our operations for the three
months ended March 31, 2022 and 2021, together with the changes in those items
in thousands of dollars and as a percentage.


                                               Three Months Ended March 31, 

$ Increase /

                                                 2022                 2021            (Decrease)        % Change
Collaboration revenue from related party    $          268       $            -     $          268            100 %
Operating expenses:
Research and development                            14,191                9,748              4,443             46 %
General and administrative                           5,406                2,745              2,661             97 %
Related party expense, net                             630                  449                181             41 %
Total operating expenses                            20,227               12,942              7,285             56 %
Loss from operations                               (19,959 )            (12,942 )            7,017             54 %
Other expense, net:
Interest expense, net                                 (155 )               (212 )              (57 )          (27 )%
Change in fair value of warrant liability                -                 (330 )             (330 )         (100 )%
Other income (expense), net                            (50 )                 (4 )               46             NM
Total other expense, net                              (205 )               (546 )             (341 )          (63 )%
Net loss                                    $      (20,164 )     $      (13,488 )   $        6,676


NM - Not meaningful

Revenue

Revenue was $0.3 million for the three months ended March 31, 2022, which
represented the reimbursement received for the costs of our research activities
performed, in connection with the collaboration agreement with PMCo. There was
no revenue for the three months ended March 31, 2021.

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Research and development expenses


Research and development expenses were $14.2 million and $9.7 million for the
three months ended March 31, 2022 and 2021, respectively. The following table
summarizes our research and development expenses by nature (in thousands).

                                                           Three Months Ended March 31,
                                                             2022                 2021
Personnel-related expenses                              $         4,343       $       1,746
Discovery and preclinical development costs,
including third-party costs (consultants,
contractors, and CDMO)                                            7,016     

4,680

Other research and development costs, including
laboratory materials and supplies                                 1,389     

1,113

Costs of licensing technology                                         1     

1,432

Facilities and overhead expenses                                  1,442                 777
Total research and development expenses                 $        14,191     

$ 9,748




Research and development expenses increased by $4.5 million to $14.2 million for
the three months ended March 31, 2022, from $9.7 million for the three months
ended March 31, 2021. The increase was primarily driven by the following:

• Increase of $2.6 million in personnel-related expenses due to an increase in
the number of employees in the research and development functions to support
business growth.

• Increase of $2.3 million in discovery and preclinical development costs and
$0.3 million in laboratory materials and supplies attributable to the increasing
external manufacturing and research efforts to support the advancement of our
pipeline and discovery portfolio, including the initiation of IND-enabling
studies.

General and administrative expenses


General and administrative expenses increased by $2.7 million to $5.4 million
for the three months ended March 31, 2022, from $2.7 million for the three
months ended March 31, 2021. The $2.7 million increase was primarily driven by
an increase of $1.3 million in personnel-related expenses, including recruiting
fees and stock-based compensation to support business growth. There was an
increase of $0.6 million due to increased directors' and officers' liability
insurance cost. The remaining $0.8 million increase was primarily attributable
to higher professional fees and consulting services associated with ongoing
business activities.

Related party expense, net


Related party expense, net was $0.6 million for the three-months ended March 31,
2022 and $0.4 million for the three months ended March 31, 2021. During the
three months ended March 31, 2022, related party expense, net primarily
consisted of lease expense and related costs incurred for our principal office
and laboratory space, management services and other reimbursable expenses to
Flagship and certain fees payable to our non-employee directors after we became
a public company, offset by the income earned from our sublessees. During the
three months ended March 31, 2021, related party expense, net primarily
consisted of lease expense and related costs incurred for our principal office
and laboratory space and management services and other reimbursable expenses to
Flagship, offset by income earned from our sublessees.

Interest expense, net

Interest expense, net was $0.2 million for both the three months ended March 31,
2022
and 2021.

Change in fair value of warrant liability


During the three months ended March 31, 2021, we recorded a $0.3 million expense
related to the change in fair value of warrant liability. Upon the closing of
the IPO, the warrants for the purchase of preferred stock automatically became
warrants for the purchase of common stock, and we reclassified the carrying
value of the warrants from liability to additional paid-in capital on our
balance sheet. In August 2021, the holders of such warrants completed a cashless
exercise of the warrants, and we issued 82,193 shares of our common stock.

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Other expense, net

Other expense, net was not significant for both of the three-month periods ended
March 31, 2022 and 2021.


                        Liquidity and capital resources

Sources of liquidity

Since our inception, we have incurred significant operating losses. We expect to
incur significant expenses and operating losses for the foreseeable future as we
support our continued research activities and development of our programs and
platform. We have not yet commercialized any products, and we do not expect to
generate product revenue for several years, if at all. To date, we have funded
our operations primarily with proceeds from sales of equity securities,
including our IPO, and borrowings under our loan and security agreement.

In August 2021, we completed our IPO pursuant to which we issued and sold
8,300,976 shares of our common stock, including 900,976 shares pursuant to the
partial exercise of the underwriters' option to purchase additional shares, at a
public offering price of $17.00 per share, for aggregate gross proceeds of
$141.1 million. We received approximately $128.1 million in net proceeds after
deducting underwriting discounts and commissions and other offering expenses
payable by us.

Cash flows

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


                                                               Three Months 

Ended March 31,

                                                                 2022       

2021

Net cash used in operating activities                       $      (23,350 )     $      (10,549 )
Net cash used in investing activities                              (57,567 )                (48 )
Net cash provided by financing activities                               83              125,413

Net change in cash, cash equivalents, and restricted cash (80,834 )

            114,816




Operating activities

Net cash used in operating activities totaled $23.4 million for the three months
ended March 31, 2022 compared to net cash used in operating activities of $10.5
million for the three months ended March 31, 2021. The $12.8 million increase in
operating cash outflows was primarily attributable to $6.7 million higher net
loss recognized during the three months ended March 31, 2022 and higher cash
outflows due to changes in operating assets and liabilities, offset by higher
non-cash charges including stock-based compensation and amortization of
right-of-use assets.

Investing activities


Net cash used in investing activities totaled $57.6 million in the three months
ended March 31, 2022 compared to net cash used in investing activities of less
than $0.1 million in the three months ended March 31, 2021. The increase was
primarily attributable to purchases of marketable securities.

Financing activities


Net cash provided by financing activities for the three months ended March 31,
2022 consisted primarily of the proceeds from the exercise of stock options. Net
cash provided by financing activities for the three months ended March 31, 2021
consisted primarily of the net proceeds from the issuance of Series C Preferred
Stock of $125.4 million.

Loan and security agreement

In March 2018, we entered into the loan and security agreement, or Loan
Agreement, with Pacific Western Bank, or PWB, under which we borrowed $8.0
million
. In September 2019, we entered into an amendment to the Loan Agreement,
or First Amendment, in which PWB made an additional term loan to us in an
aggregate principal amount of $12.0 million. The Loan Agreement was further
amended in December 2020 to extend the principal repayment date.

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In December 2021, we entered into an amendment to the Loan Agreement, or Fourth
Amendment, in which PWB made an additional term loan to us in an aggregate
principal amount of $20.0 million. The proceeds of the Fourth Amendment were
first applied to the repayment in full of all outstanding principal and accrued
interest on the then outstanding term loan of $12.0 million, and the remaining
cash proceeds of $8.0 million were used for general working capital and for
capital expenditures purposes. The maturity date of the additional term loan is
September 30, 2025, and it will be repaid beginning on September 30, 2023 in
twenty-four equal monthly installments, including interest at a floating annual
rate equal to the greater of (i) 0.50% above the prime rate then in effect and
(ii) 5.50%, due monthly starting the first month after December 20, 2021. As of
March 31, 2022, the interest rate applicable to the term loan was 5.50% and the
interest payment on the outstanding term loan was less than $0.1 million per
month.

Borrowings under the Loan Agreement, as amended, are collateralized by
substantially all of our personal property, other than our intellectual
property. There are no financial covenants associated with the Loan Agreement,
as amended; however, we are subject to certain affirmative and negative
covenants to which we will remain subject to until maturity.

Funding requirements


As of March 31, 2022, we had cash, cash equivalents and marketable securities of
$200.8 million. We expect that our expenses will increase substantially in
connection with our ongoing activities, particularly as we advance preclinical
activities and into clinical trials for our product candidates in development.
In addition, we will continue to incur additional costs associated with
operating as a public company. The timing and amount of our operating and
capital expenditures will depend largely on:

• the scope, progress, results, and costs of our preclinical studies and any
future clinical trials;

• the timing of, and the costs involved in, obtaining marketing approvals for
our current and future product candidates in regions where we choose to
commercialize any products;

• the number of future product candidates and potential additional indications
that we may pursue and their development requirements;

• the stability, scale, yield, and cost of our manufacturing process as we
scale-up production and formulation of our product candidates for clinical
trials, in preparation for regulatory approval and in preparation for
commercialization, including our ability to build our own manufacturing
facility;

• the costs of pre- and post-commercialization activities for any approved
product, including the costs and timing of establishing product sales,
marketing, distribution, and manufacturing capabilities;

• revenue, if any, received from commercial sales of our products, should any of
our product candidates receive marketing approval;

• the costs and timing of changes in pharmaceutical pricing and reimbursement
infrastructure;

• the costs and timing of changes in the regulatory environment and enforcement
rules;

• our ability to compete with other therapeutics in the indications we target;

• the effect of competing technological and market developments;

• the extent to which we enter into collaborations or licenses for products,
product candidates, or technologies;

• our headcount growth and associated costs as we expand our research and
development capabilities and establish a commercial infrastructure;

• the costs of preparing, filing, and prosecuting patent applications and
maintaining and protecting our intellectual property rights, including enforcing
and defending intellectual property-related claims;

• the costs of operating as a public company; and

• the severity, duration, and impact of the COVID-19 pandemic, which may
adversely impact our business.


We believe that the net proceeds from our IPO, together with our existing cash,
cash equivalents and marketable securities, will enable us to fund our operating
expenses and capital expenditure requirements for at least the next 12 months
from the filing date of the Quarterly Report. We have based this estimate on
assumptions that may prove to be incorrect, and we could utilize our available
capital resources sooner than we expect. Until such time, if ever, as we can
generate substantial product revenue, we expect to finance our operations
through equity offerings, debt financings, marketing and distribution
arrangements and other collaborations, strategic alliances and licensing
arrangements, or other sources.

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                            Contractual obligations

There have been no material changes to our contractual obligations as of March
31, 2022
from those disclosed in our 2021 10-K.

                   Critical accounting policies and estimates

Our management's discussion and analysis of our financial condition and results
of operations are based on our unaudited financial statements, which have been
prepared in accordance with accounting principles generally accepted in the
U.S., or GAAP. The preparation of these unaudited financial statements requires
us to make estimates and judgments that affect the reported amounts of assets,
liabilities, costs and expenses. On an ongoing basis, we evaluate these
estimates and judgments, including those described below. We base our estimates
on historical experience and on various other assumptions that we believe to be
reasonable under the circumstances. These estimates and assumptions form the
basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results and experiences
may differ materially from these estimates.

Our critical accounting policies are described under the heading "Management's
Discussion and Analysis of Financial Condition and Results of
Operations-Critical Accounting Policies and Estimates" in our 2021 10-K and the
notes to the unaudited financial statements appearing elsewhere in this
Quarterly Report on Form 10-Q. During the three months ended March 31, 2022,
there were no material changes to our critical accounting policies from those
discussed in our 2021 10-K.

                   Recently Issued Accounting Pronouncements

We have reviewed all recently issued accounting pronouncements and have
determined that, other than as disclosed in Note 2 - Summary of Significant
Accounting Policies in the notes to the audited financial statements included in
our 2021 10-K and the notes to the unaudited financial statements appearing
elsewhere in this Quarterly Report on Form 10-Q, such standards will not have a
material impact on our financial statements or do not otherwise apply to our
current operations.

Emerging growth company and smaller reporting company status


We qualify as an "emerging growth company" as defined in the Jumpstart Our
Business Startups Act of 2012, or the JOBS Act. As a result, we may take
advantage of specified reduced disclosure and other reporting requirements that
are otherwise applicable generally to public companies. In particular, the JOBS
Act provides that an emerging growth company can take advantage of an extended
transition period for complying with new or revised accounting standards. We
have elected not to "opt out" of such extended transition period, which means
that when a standard is issued or revised and it has different application dates
for public or private companies, we may adopt the new or revised standard at the
time private companies adopt the new or revised standard and may do so until
such time that we either (i) irrevocably elect to "opt out" of such extended
transition period or (ii) no longer qualify as an emerging growth company.

We are also a "smaller reporting company" as defined under the Securities Act
and Exchange Act. We may continue to be a smaller reporting company so long as
either (i) the market value of shares of our common stock held by non-affiliates
is less than $250 million or (ii) our annual revenue was less than $100 million
during the most recently completed fiscal year and the market value of shares of
our common stock held by non-affiliates is less than $700 million. If we are a
smaller reporting company at the time we cease to be an emerging growth company,
we may continue to rely on exemptions from certain disclosure requirements that
are available to smaller reporting companies. Specifically, as a smaller
reporting company, we may choose to present only the two most recent fiscal
years of audited financial statements in our Annual Report on Form 10-K and have
reduced disclosure obligations regarding executive compensation, and, similar to
emerging growth companies, if we are a smaller reporting company under the
requirements of (ii) above, we would not be required to obtain an attestation
report on internal control over financial reporting issued by our independent
registered public accounting firm.

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