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    INAB   US45674E1091

IN8BIO, INC.

(INAB)
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IN8BIO : Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

09/10/2021 | 04:33pm EST

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the years ended December 31, 2020 and 2019, which are included in the final prospectus that forms a part of our Registration Statement on Form S-1 (File No. 333-249530) for our initial public offering, or IPO, dated July 29, 2021, that was filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act, on July 30, 2021, which we refer to as the Prospectus.

Overview

We are a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems, and can intrinsically differentiate between healthy and diseased tissue. These cells serve as a functional bridge between innate and adaptive immunity to contribute to direct tumor killing, as well as immune cell recruitment and activation to drive deeper immune responses. The pivotal role of gamma-delta T cells in immune function and activation, against diseases such as cancer, underscores their therapeutic potential across a wide range of solid and hematologic malignancies. We develop ex vivo-expanded and activated gamma-delta T cell candidates based upon our deep expertise in gamma-delta T cell biology, proprietary genetic engineering and cell-type specific manufacturing capabilities, which we refer to collectively as our DeltEx platform. Our platform employs allogeneic, autologous and genetically modified approaches to develop novel cell therapies, which are designed to effectively identify and eradicate tumor cells. We are currently the most clinically advanced gamma-delta T cell company. Our lead product candidates are currently in Phase 1 clinical trials: INB-200, for the treatment of newly diagnosed glioblastoma, or GBM, and INB-100, for the treatment of patients with leukemia that are undergoing hematopoietic stem cell transplantation, or HSCT. For INB-200, we expect to report the initial results from the second and third cohorts in this Phase 1 trial in 2022. For INB-100, we expect to report initial results from the first cohort in our Phase 1 clinical trial in 2022, with additional results in 2023. In addition, our DeltEx platform has yielded a broad portfolio of preclinical programs, including INB-400 and INB-300, focused on addressing other solid tumor types. We expect to file three INDs for our pipeline product candidates through 2023 with a total of four planned INDs over the next three years, including one in an undisclosed indication.

Since inception in 2016, our operations have focused on identifying and developing potential product candidates, conducting clinical trials, organizing and staffing the Company, business planning, establishing our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. We do not have any product candidates approved for sale and have not generated any revenue. We have funded our operations primarily through the sale of equity and equity-linked securities. Through June 30, 2021, we raised an aggregate of $35.6 million of gross proceeds from the sale of our securities.

We have incurred significant operating losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of one or more of our product candidates. Our net losses were $5.4 million and $4.6 million for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, we had an accumulated deficit of $23.5 million.

We expect our expenses and operating losses will increase substantially for the foreseeable future as we advance INB-100 and INB-200 through clinical trials, seek to expand our product candidate portfolio through developing additional product candidates, grow our clinical, regulatory and quality capabilities, and incur additional costs associated with operating as a public company. It is likely that we will seek third-party collaborators for the future commercialization of INB-100, INB-200 or any other product candidate that is approved for marketing. However, we may seek to commercialize our products at our own expense, which would require us to incur significant additional expenses for marketing, sales, manufacturing and distribution.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such


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agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.

As of June 30, 2021, we had cash of $12.0 million. In August 2021, we issued and sold 4,000,000 shares of our common stock at a price to the public of $10.00 per share for aggregate gross proceeds of $40.0 million in our IPO. We received approximately $32.6 million in net proceeds after deducting underwriting discounts, commissions and estimated offering expenses. Based on our current operating plan, we expect that our cash of $12.0 million as of June 30, 2021, and net proceeds of $32.6 million from the IPO will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 months from the issuance of the condensed financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See "-Liquidity and Capital Resources."


Recent Business Highlights

?
During the second quarter, we presented data demonstrating in vitro activity of
INB-300, our DeltEx drug-resistant immunotherapy (DRI) CAR-T cells against GBM
at the American Association of Cancer Research (AACR) Annual Meeting 2021.
Gamma-delta T cells were engineered with a chlorotoxin CAR-T binding domain and
a chemotherapy resistance gene, which enhances binding to tumor cells and
survival of concomitant dosing with alkylating chemotherapies, such as
temozolomide, or TMZ.
?
During the second quarter, we presented data at the 2021 American Society of
Clinical Oncology (ASCO) Annual Meeting from the first cohort of a Phase 1
clinical trial of INB-200 in patients with newly diagnosed GBM. INB-200 was
generally well tolerated with no observed infusion reactions, cytokine release
syndrome, neurotoxicity or dose limiting toxicities (DLTs). Enrollment for the
second cohort of this trial was initiated. All three treated patients exceeded
their expected median progression-free survival based on their respective age
and O-6-Methylguanine-DNA Methyltransferase (MGMT) status. We expect to report
additional data from this Phase 1 trial by the end of 2021.
?
In July 2021, we appointed Emily Fairbairn and Luba Greenwood as two independent
members into our Board of Directors. Ms. Fairbairn is currently a principal of
Transcend Partners and was co-founder and CEO of Ascend Capital. Ms. Greenwood
serves as Managing Partner of Binney Street Capital LLC, a venture capital fund
established by the Dana Farber Cancer Institute.
?
In August 2021, we completed dosing of the first cohort of INB-100, a Phase 1
clinical trial of donor-derived allogeneic gamma-delta T cells in leukemia
patients undergoing HSCT. No severe adverse infusion reactions or DLTs were
observed. The first two patients continue in complete remission more than one
year after treatment. We expect to report initial results from the first cohort
in this Phase 1 trial in 2022, with topline results for all cohorts in 2023.


Our Pipeline

[[Image Removed: img237016903_0.jpg]]


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Impact of COVID-19

The ongoing COVID-19 pandemic has had a significant impact, both direct and indirect, on businesses and commerce, as certain worker shortages have occurred, supply chains have been disrupted, and facilities and production have been suspended. The COVID-19 pandemic has impacted and may continue to impact the clinical sites and startup activities for the Company's Phase 1/2 clinical trial, including third-party manufacturing and logistics providers, which have disrupted and may continue to disrupt its clinical supply chain and the availability or cost of materials, and it has affected and may continue to affect the Company's ability to timely initiate, enroll and complete its clinical trials, conduct regulatory activities and its operate its business more generally. The Company continues to monitor the potential impact of COVID-19 on its business and financial statements and cannot be certain what the overall impact of the COVID-19 pandemic will be. The extent to which the COVID-19 pandemic will directly or indirectly continue to impact its business, results of operations, financial condition and liquidity, including ongoing and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of evolving variants of COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects.

Components of Our Results of Operations

Revenue

Since inception, we have not generated any revenue and do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for one or more of our product candidates are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration or license agreements.

Operating Expenses

Research and Development Expense

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our product candidates, and include:


?
employee-related expenses, including salaries, related-benefits and stock-based
compensation expense for employees engaged in research and development
functions;
?
fees paid to consultants for services directly related to our product
development and regulatory efforts;
?
preclinical studies-expenses associated with conducting preclinical studies
performed by ourselves, outside vendors or academic collaborators;
?
expenses incurred under agreements with contract research organizations, or
CROs, as well as contract manufacturing organizations, or CMOs, and consultants
that conduct and provide supplies for our preclinical studies and clinical
trials;
?
costs associated with preclinical activities and development activities;
?
costs associated with our intellectual property portfolio; and
?
costs related to compliance with regulatory requirements.

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. 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 financial statements as prepaid or accrued research and development expenses. Beginning with fiscal year 2020, we allocate our direct external research and development costs across each product candidate. Preclinical expenses consist of external research and development costs associated with activities to support our current and future clinical programs, but are not allocated by product candidate due to the overlap of the potential benefit of those efforts across multiple product candidates.

Research and development activities are central to our business. We expect that our research and development expenses will continue to increase for the foreseeable future as we continue clinical development for our product candidates and continue to discover and develop additional product candidates. If any of our product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.


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General and Administrative Expense

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive and finance functions. General and administrative expenses also include professional fees for legal, accounting, auditing, tax and consulting services; travel expenses; and facility-related expenses, which include allocated expenses for rent and maintenance of facilities and other operating costs not included in research and development.

We expect that our general and administrative expenses will increase as our organization and headcount needed in the future grow to support continued research and development activities and potential commercialization of our product candidates. These increases will likely include increased costs related to building a team to support our administrative, accounting and finance, communications, legal and business development efforts. Following the IPO, we expect to incur increased expenses associated with being a public company, including costs of additional personnel, accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements; director and officer insurance costs; and investor and public relations costs.

Income Taxes

Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development tax credits earned in each year, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.

Results of Operations

Comparison of the Three Months Ended June 30, 2021 and 2020


The following sets forth our results of operations for the three months ended
June 30, 2021 and 2020:



                                 Three Months Ended June 30,
(in thousands)                    2021                 2020          Change
Operating expenses:
Research and development     $        2,064       $        1,784     $   280
General and administrative              986                1,090        (104 )
Total operating expenses              3,050                2,874         176
Loss from operations                 (3,050 )             (2,874 )      (176 )
Net loss                     $       (3,050 )     $       (2,874 )   $  (176 )



Research and Development Expenses

Research and development expenses were $2.1 million and $1.8 million for the three months ended June 30, 2021 and 2020, respectively. The increase of $0.3 million was primarily due to increased third-party costs for the ongoing clinical trial for INB-200 and increased personnel-related costs, including stock-based compensation.

General and Administrative Expenses

General and administrative expenses were $1.0 million and $1.1 million for the three months ended June 30, 2021 and 2020, respectively. The decrease of $0.1 million was primarily due to decreased legal and professional fees partially offset by increased personnel costs, including non-cash stock-based compensation, in anticipation of becoming a public company.




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Comparison of the Six Months Ended June 30, 2021 and 2020


The following sets forth our results of operations for the six months ended June
30, 2021 and 2020:



                                 Six Months Ended June 30,
(in thousands)                   2021                2020          Change
Operating expenses:
Research and development     $       3,310       $       2,836     $   474
General and administrative           2,103               1,729         374
Total operating expenses             5,413               4,565         848
Loss from operations                (5,413 )            (4,565 )      (848 )
Net loss                     $      (5,413 )     $      (4,565 )   $  (848 )



Research and Development Expenses

Research and development expenses were $3.3 million and $2.8 million for the six months ended June 30, 2021 and 2020, respectively. The increase of $0.5 million was primarily due to increased third-party costs for the ongoing clinical trial for INB-200 and increased personnel related costs, including stock-based compensation.

General and Administrative Expenses

General and administrative expenses were $2.1 million and $1.7 million for the six months ended June 30, 2021 and 2020, respectively. The increase of $0.4 million was primarily due to increased personnel costs, including stock-based compensation, in anticipation of becoming a public company.

Liquidity and Capital Resources

Overview

To date we have funded our operations primarily through the sale of equity and equity-linked securities. Through June 30, 2021, we have raised an aggregate of $35.6 million of gross proceeds from private placements of our equity securities. In August 2021, we completed our IPO in which we issued and sold 4,000,000 shares of our common stock at a public offering price of $10.00 per share for aggregate gross proceeds of $40.0 million. We received approximately $32.6 million in net proceeds after deducting underwriting discounts, commissions and estimated offering expenses.

As of June 30, 2021, we had cash of $12.0 million, which excludes the net proceeds of $32.6 million received from the IPO. Our net loss was $5.5 million and $4.6 million for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, we had an accumulated deficit of $23.5 million. Since inception, we have not generated any product revenue and have incurred net losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for the foreseeable future, if at all. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.

Cash Flows


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



                                                            Six Months Ended June 30,
(in thousands)                                              2021                2020
Net cash used in operating activities                   $      (4,968 )     $      (3,284 )
Net cash used in investing activities                               -                   -
Net cash (used in) provided by financing activities            (1,027 )             5,854
Net (decrease) increase in cash                         $      (5,995 )     $       2,570




Operating Activities

Cash used in operating activities was $5.0 million during the six months ended June 30, 2021, primarily due to our net loss of $5.4 million and decrease in our operating assets and liabilities of $0.7 million partially offset by increases in non-cash charges of $1.1 million. Decreases in our operating assets and liabilities consisted primarily of $0.4 million in accounts payable mainly due to deferred


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offering costs payments related to the IPO, $0.2 million in accrued expenses and other current liabilities mainly due to lower legal accruals as a result of the completion of the IPO, and $0.1 million in prepaid expenses and other current assets mainly due to lower clinical prepaids for the quarter. Increases in our non-cash charges consisted primarily of $0.8 million in stock-based compensation due to higher employee headcount and $0.3 million in amortization of operating and finance leases for the quarter.

Cash used in operating activities was $3.3 million during the six months ended June 30, 2020, primarily due to our net loss of $4.6 million offset by increases in our operating assets and liabilities of $1.2 million and increases in non-cash charges of $0.1 million. Increases in our operating assets and liabilities consisted primarily of $1.2 million in accrued expenses and other current liabilities due to increased legal accruals related to preparing for the IPO. Increases in our non-cash charges consisted primarily of $0.1 million in stock-based compensation due to higher employee headcount.

Financing Activities

Cash used in financing activities was $1.0 million during the six months ended June 30, 2021, primarily due to paying deferred offering costs related to our IPO, which closed in August 2021.

Cash provided by financing activities was $5.9 million during the six months ended June 30, 2020, primarily due to the issuance of Series A convertible preferred stock.

Funding Requirements

Our plan of operation is to continue implementing our business strategy, continue research and development of INB-100 and INB-200 and our other product candidates and continue to expand our research pipeline and our internal research and development capabilities. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company following our IPO. It is likely that we will seek third-party collaborators for the future commercialization of INB-100, INB-200 or any other product candidate that is approved for marketing. However, we may seek to commercialize our products at our own expense, which would require us to incur significant additional expenses for marketing, sales, manufacturing and distribution.

We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Our future capital requirements will depend on many factors, including:


?
the scope, timing, progress, costs, and results of discovery, preclinical
development, and clinical trials for our current and future product candidates;
?
the number of clinical trials required for regulatory approval of our current
and future product candidates;
?
the costs, timing, and outcome of regulatory review of any of our current and
future product candidates;
?
the cost of manufacturing clinical and commercial supplies of our current and
future product candidates;
?
the costs and timing of future commercialization activities, including
manufacturing, marketing, sales, and distribution, for any of our product
candidates for which we receive marketing approval;
?
the costs and timing of preparing, filing, and prosecuting patent applications,
maintaining and enforcing our intellectual property rights, and defending any
intellectual property-related claims, including any claims by third parties that
we are infringing upon their intellectual property rights;
?
our ability to maintain existing, and establish new, strategic collaborations,
licensing, or other arrangements and the financial terms of any such agreements,
including the timing and amount of any future milestone, royalty, or other
payments due under any such agreement;
?
the revenue, if any, received from commercial sales of our product candidates
for which we receive marketing approval;
?
expenses to attract, hire and retain skilled personnel;
?
the costs of operating as a public company;
?
our ability to establish a commercially viable pricing structure and obtain
approval for coverage and adequate reimbursement from third-party and government
payers;
?
addressing any potential interruptions or delays resulting from factors related
to the ongoing COVID-19 pandemic;

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?

the effect of competing technological and market developments; and ? the extent to which we acquire or invest in businesses, products and technologies.

A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations from the sale of additional equity or debt financings, or other capital which comes in the form of strategic collaborations, licensing, or other arrangements. In the event that additional financing is required, we may not be able to raise it on terms acceptable to us, or at all. If we raise additional funds through the issuance of equity or convertible debt securities, it may result in dilution to our existing stockholders. Debt financing or preferred equity financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations.

If we raise funds through strategic collaboration, licensing or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic and otherwise. 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 development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Commitments

Effective January 1, 2021, the Company early adopted Accounting Standards Update ("ASU") No. 2016-02, Leases (Topic 842) ("ASU 2016-02" or "ASC 842"), using the modified retrospective method and utilized the effective date as its date of initial application, with prior periods presented in accordance with previous guidan ASC 840, Leases. On the adoption date, $1.7 million was recognized as total lease liabilities and $1.8 million was recognized as total right-of-use assets on the Company's balance sheet. For more information regarding the adoption, please see Note 2 and Note 13 included in this quarterly report. There were no material changes to our contractual obligations and commitments during the six months ended June 30, 2020 from those described under "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Prospectus.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the U.S. Securities and Exchange Commission.

Critical Accounting Policies and Significant Judgements and Estimates

This Management's Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which are prepared in accordance with US GAAP. The preparation of our financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.

We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. Our significant accounting policies are more fully described in Note 2 to our unaudited condensed financial statements located in "Part I - Financial Information, Item 1. Financial Statements" in this Quarterly Report on Form 10-Q.

There have been no significant changes to our critical accounting policies from those described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our final Prospectus dated July 29, 2021 and filed with the SEC pursuant to Rule 434(b)(4) under the Securities Act, on July 30, 2021.


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Recent Accounting Pronouncements

See Note 2 in our condensed financial statements in "Part I - Financial Information, Item 1. Condensed Financial Statements" in this Quarterly Report on Form 10-Q for a description of recent accounting pronouncements applicable to our financial statements.

Emerging Growth Company and Smaller Reporting Company Status

We qualify as an EGC, as defined in the JOBS Act. As an EGC, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.

We may take advantage of these exemptions until December 31, 2026 or such earlier time that we are no longer an emerging growth company. We would cease to be an EGC earlier if we have more than $1.07 billion in annual revenue, we have more than $700.0 million in market value of our stock held by non-affiliates (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or we issue more than $1.0 billion of non-convertible debt securities over a three-year period. For so long as we remain an EGC, we are permitted, and intend, to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not EGCs. We may choose to take advantage of some, but not all, of the available exemptions.

In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. 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 will adopt the new or revised standard at the time private companies adopt the new or revised standard and will 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 EGC. Therefore, the reported results of operations contained in our financial statements may not be directly comparable to those of other public companies.

We are also a "smaller reporting company," meaning that the market value of our stock held by non-affiliates was less than $700 million at the closing of the IPO and our annual revenue for 2020 was less than $100 million. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our 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 EGC, 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, similar to EGCs, smaller reporting companies have reduced disclosure obligations regarding executive compensation.


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