The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes appearing at the end of this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, 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 Annual Report on Form 10-K, 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.
Overview
We are a clinical-stage biopharmaceutical company focused on developing a robust
pipeline of T cell receptor-engineered T cell, or TCR-T, therapies for the
treatment of patients with cancer. Our approach is based on the central premise
that we can learn from patients
We are advancing a robust pipeline of TCR-T therapy candidates for the treatment of patients with hematologic malignancies and solid tumors. Our lead product candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual leukemia and prevent relapse following hematopoietic cell transplantation, or HCT. TSC-100 and TSC-101 target HA-1 and HA-2 antigens, respectively, which are well-recognized TCR targets that were identified in patients with exceptional responses to HCT-associated immunotherapy. We have initiated a multi-arm Phase 1 clinical study of TSC-100 and TSC-101 with several clinical sites activated, with planned additional sites to be added in 2023.
In addition, we are developing multiple TCR-T therapy candidates for the
treatment of solid tumors. One of the key goals for our solid tumor program is
to develop what we refer to as multiplexed TCR-T therapy. We are designing these
multiplexed therapies to be a combination of up to three highly active TCRs that
are customized for each patient and selected from our bank of therapeutic TCRs,
which we refer to as the ImmunoBank. We plan to populate the ImmunoBank with
TCRs for multiple targets as well as multiple HLA types for each target, thus
helping us to overcome key solid tumor resistance mechanisms of target loss and
HLA loss. We are currently advancing six solid tumor programs: TSC-204, entering
Phase 1 development; TSC-200 and TSC-203, in IND-enabling activities; TSC-201,
in lead optimization; and TSC-202 and TSC-205, in discovery. In
Since our inception in 2018, we have devoted our efforts to raising capital,
obtaining financing, filing, prosecuting and maintaining intellectual property
rights, organizing and staffing our company and incurring research and
development costs related to the identification of novel targets for TCRs and
development of TCR-T therapies to target and eliminate cancer cells. We do not
have any therapies approved for sale and have not generated any revenue from
product sales. To date, we have funded our operations primarily with proceeds
from sales of convertible preferred stock, proceeds from the initial public
offering ("IPO") completed in
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conclude in
Impact of COVID-19
In
In response to public health directives and orders and to help minimize the risk of the virus to employees, we have taken a series of actions aimed at safeguarding our employees and business associates, including implementing a flexible work-at-home policy. These disruptions could result in increased costs of execution of development plans or may negatively impact the quality, quantity, timing and regulatory usability of data that we would otherwise be able to collect. While these disruptions are currently expected to be temporary, there is considerable uncertainty around the duration of these disruptions. Therefore, the related financial impact and duration cannot be reasonably estimated at this time.
Initial Public Offering
On
Components of Results of Operations
Revenue
To date, our revenue has been derived from our one collaboration and two licensing agreements. We have not generated any revenue from the sale of therapies to date, nor do we expect to generate revenues therefrom in the near future, if at all. If our development efforts for our product candidates are successful and result in regulatory approval or if we enter into additional license or collaboration agreements with third parties, we may generate additional revenue in the future from sales of our therapies, payments from license or collaboration agreements that we may enter into with third parties, or any combination thereof. However, there can be no assurance as to when we will generate such revenue, if at all. We expect that our revenue for at least the next several years will be derived primarily from collaborations and licenses that we may enter into in the future, if any.
Collaboration Revenue
In
The collaboration included an upfront fee and research funding together totaling
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See Note 8, Collaboration and License Agreements, to our audit financial statements included elsewhere in this Annual Report.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with our research activities, including our therapeutic discovery efforts, preclinical and clinical trials, and the development of our proprietary platform technologies and product candidates. We expense research and development costs as incurred, which include:
•
employee-related expenses, including salaries, bonuses, benefits, stock-based compensation, and other related costs for those employees involved in research and development efforts;
•
expenses incurred in connection with our research programs, including under agreements with third parties, such as consultants and contract research organizations, or CROs;
•
the cost of raw materials, developing and scaling our manufacturing process, and manufacturing our product candidates for use in our research and preclinical studies, including under agreements with third parties, such as consultants, contractors, and contract manufacturing organizations, or CMOs;
•
laboratory supplies and research materials;
•
facilities, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance; and
•
payments made under third party licensing agreements.
We expense research and development costs as incurred. Non-refundable 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. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered. Upfront payments under license agreements are expensed upon receipt of the license, and annual maintenance fees under license agreements are expensed in the period in which they are incurred. Milestone payments under license agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable.
Our direct external research and development expenses consist of costs that include fees, reimbursed materials, direct material costs, and other costs paid to consultants, contractors, CMOs and CROs in connection with our development and manufacturing activities. We do not allocate employee costs, general laboratory supplies, and facilities expenses, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple programs and our platform technology and, as such, are not separately classified. When our TCR-T therapy candidates enter clinical development, we will begin to segregate related research and development expenses by product candidate.
Product candidates in later stages of clinical development generally have higher development costs than those in preclinical and earlier stages of clinical development, primarily due increased size and duration of later stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our planned preclinical and clinical development activities in the near term and in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. The successful development and commercialization of our product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with therapeutic development and commercialization, including the following:
•
the number and scope of preclinical and clinical programs we decide to pursue;
•
the timing and progress of preclinical and clinical development activities for each program;
•
our ability to raise additional funds necessary to complete preclinical and clinical development of and commercialize our product candidates;
•
the progress of the development efforts of parties with whom we may enter into collaboration arrangements;
•
our ability to maintain our current research and development programs and to establish new ones;
•
our ability to establish new licensing or collaboration arrangements;
•
the successful initiation and completion of clinical trials with safety,
tolerability and efficacy profiles that are satisfactory to the
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•
the receipt and related terms of regulatory approvals from applicable regulatory authorities;
•
the availability of raw materials for use in the manufacture of our product candidates;
•
our ability to consistently manufacture our product candidates for use in clinical trials;
•
our ability to establish and operate a manufacturing facility, or secure manufacturing supply through relationships with third parties;
•
our ability to obtain and maintain patents, trade secret protection and
regulatory exclusivity, both in
•
our ability to protect our rights in our intellectual property portfolio;
•
the commercialization of our product candidates, if and when approved;
•
obtaining and maintaining third party insurance coverage and adequate reimbursement;
•
the acceptance of our product candidates, if approved, by patients, the medical community and third party payors;
•
competition with other products and therapies; and
•
a continued acceptable safety profile of our therapies following approval.
A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of these product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates or in establishing market acceptance for any product candidates that may be approved.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and personnel expenses, including stock-based compensation, for our personnel in executive, legal, finance and accounting, human resources, and other administrative functions. General and administrative expenses also include legal fees relating to corporate matters; professional fees paid for accounting, auditing, consulting, and tax services; insurance costs; travel expenses; and facility costs not otherwise included in research and development expenses.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We have incurred significantly increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company and anticipate these expenses to increase in 2023 as we continue to expand the business. In addition, if we obtain regulatory approval for a product candidate and do not enter into a third-party commercialization collaboration, we expect to incur significant expenses related to building a sales and marketing team to support sales, marketing and distribution activities.
As of
Other Income
Other income consists primarily of interest earned on our cash and cash equivalents balances held in financial institutions.
Interest Expense
Interest expense consists of interest associated with our outstanding debt obligation, including the amortization of debt issuance costs.
Income Taxes
Since our inception, we have not recorded any
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carryforwards of
Results of Operations
Years ended
The following table summarizes our results of operations for the years ended
Year Ended December 31, 2022 2021 Change
Revenue
Collaboration and license revenue$ 13,535 $ 10,141 $ 3,394 Operating expenses: Research and development 59,819 44,954 14,865 General and administrative 20,352 13,828 6,524 Total operating expenses 80,171 58,782 21,389 Loss from operations (66,636 ) (48,641 ) (17,995 ) Other income: Interest and other income, net 1,591 16 1,575 Interest expense (1,176 ) - (1,176 ) Total other income 415 16 399 Net loss$ (66,221 ) $ (48,625 ) $ (17,596 ) Revenue
We had
Research and Development Expenses
The following table summarizes our research and development expenses for the
years ended
Year Ended December 31, 2022 2021 Change
Laboratory supplies, research materials and studies
19,485 12,481 7,004 Facility-related and other 11,506 7,150 4,356 Clinical studies 2,492 630 1,862 Legal and professional fees 1,754 1,087 667 Total research and development expenses$ 59,819 $ 44,954 $ 14,865
The increase in research and development expenses was primarily attributable to
a
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General and Administrative Expenses
The following table summarizes our general and administrative expenses for the
years ended
Year Ended December 31, 2022 2021 Change Personnel expenses (including stock-based compensation)$ 11,224 $ 6,681 $ 4,543 Legal and professional fees 4,175 4,042 133 Facility-related and other 4,953 3,105 1,848 Total general and administrative expenses 20,352 13,828 6,524
The increase in general and administrative expenses was primarily due to a
Liquidity and Capital Resources
Sources of Liquidity
We have not generated any revenue from product sales and have incurred net
losses and negative cash flows from our operations. 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.
Under the terms of the Novartis Agreement, we received an upfront payment of
Funding requirements
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance our research programs into preclinical and clinical development. The timing and amount of our operating expenditures will depend largely on:
•
the identification of additional research programs and product candidates;
•
the scope, progress, results and costs of research and development for our current and future product candidates, including our current and planned clinical trials, and ongoing preclinical development for our current and future product candidates;
•
the costs, timing and outcome of regulatory review of any product candidates we may develop;
•
our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate a clinical trial;
•
our decision to develop and expand our manufacturing capabilities;
•
our decision to invest in facilities to enable growth;
•
investing in next-generation T cell engineering capabilities;
•
changes in laws or regulations applicable to any product candidates we may develop, including but not limited to clinical trial requirements for approvals;
•
the cost and timing of obtaining materials to produce adequate supply for any preclinical or clinical development of any product candidate we may develop;
•
the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any product candidate we may develop for which we obtain marketing approval;
•
the legal costs involved in prosecuting patent applications and enforcing patent claims and other intellectual property claims;
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•
additions or departures of key scientific or management personnel;
•
our ability to establish and maintain collaborations on favorable terms, if at all, as well as the costs and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder; and
•
the costs of continuing to operate as a public company.
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2024. We have based this estimate on assumptions that may prove to be wrong, 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 a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. 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 acquisitions or capital expenditures or declaring dividends. If we raise additional funds through additional collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product 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 have not yet received regulatory approval for or commercialized any of our product candidates and do not expect to generate revenue from product sales for several years, if at all. We do not expect to generate any product revenue unless and until we (1) complete development of any of our product candidates; (2) obtain applicable regulatory approvals; and (3) successfully commercialize or enter into collaborative agreements for our product candidates. We do not know with certainty when, or if, any of these items will ultimately occur. We expect to incur continuing significant losses for the foreseeable future and our losses to increase as we ramp up our preclinical and clinical development programs. We may encounter unforeseen expenses, difficulties, complications, delays and other currently unknown factors that could adversely affect our business.
Moreover, as a public company, we incur significant legal, accounting and other
expenses that we were not required to incur as a private company. We furnished
the first report by our management on our internal control over financial
reporting for this year ending
We will require additional capital to develop our product candidates and fund our operations into the foreseeable future. We anticipate that we will eventually need to raise substantial additional capital, the requirements for which will depend on many factors, including:
•
the scope, timing, rate of progress and costs of our drug discovery efforts, preclinical development activities, laboratory testing and clinical trials for our product candidates;
•
the number and scope of clinical programs we decide to pursue;
•
the cost, timing and outcome of preparing for and undergoing regulatory review of our product candidates;
•
the scope and costs of development and manufacturing activities;
•
the cost and timing associated with commercializing our product candidates, if they receive marketing approval;
•
the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;
•
the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we might have at such time;
•
the extent to which we acquire or in-license other product candidates and technologies;
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•
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•
our ability to establish and maintain collaborations on favorable terms, if at all;
•
our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates and, ultimately, the sale of our products, following FDA approval;
•
our implementation of various computerized information systems;
•
impact of COVID-19 on our clinical development or operations; and
•
the costs associated with being a public company.
A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions, in addition to those contained in our Loan Agreement. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.
Adequate funding may not be available to us on acceptable terms or at all. Our potential inability to raise capital when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If we are unable to raise additional funds as required, we may need to delay, reduce, or terminate some or all development programs and clinical trials. We may also be required to sell or license our rights to product candidates in certain territories or indications that we would otherwise prefer to develop and commercialize ourselves. If we are required to enter into collaborations and other arrangements to address our liquidity needs, we may have to give up certain rights that limit our ability to develop and commercialize our product candidates. See Part 2, Item 1A. "Risk Factors" of this Annual Report for additional risks associated with our substantial capital requirements.
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):
Year Ended December 31, 2022 2021 Change Net cash used in operating activities$ (66,503 ) $ (48,677 ) $ (17,826 ) Net cash used in investing activities (4,225 ) (9,941 ) 5,716 Net cash provided by financing activities 29,356 189,668 (160,312 ) Net increase (decrease) in cash, cash equivalents and restricted cash$ (41,372 ) $ 131,050 $ (172,422 ) Operating Activities
During the year ended
•
our net loss of
•
a decrease in deferred revenue of
•
an increase in right-of-use assets and lease liabilities, net of
These were partially offset by:
•
non-cash charges of
•
an increase in accrued expenses of
•
an increase in accounts payable of
During the year ended
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•
our net loss of
•
an increase in prepaid and other current assets of
•
a decrease in deferred revenue of
These were partially offset by:
•
non-cash charges of
•
an increase in accrued expenses and other current liabilities of
Investing Activities
During the years ended
Financing Activities
During the year ended
During the year ended
Contractual Obligations
See Note 10, Loan and Security Agreement, to our audited financial statements included elsewhere in this Annual Report for a discussion of obligations in relation to the Loan Agreement with K2HV.
See Note 9, Commitments and Contingencies, to our audited financial statements included elsewhere in this Annual Report for a discussion of obligations in relation to our leases.
Critical Accounting Policies and Estimates
Our consolidated financial statements are prepared in accordance with generally
accepted accounting principles in
While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue recognition
To date, our revenues have primarily consisted of consideration related to the
Novartis Agreement. We adopted the provisions of Accounting Standards Update
2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606, on
To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, we perform the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the assessment of the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as we satisfy each performance obligation.
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As part of the accounting for arrangements under ASC 606, we must use significant judgment to determine the performance obligations based on the determination under step (ii) above. We also use judgment to determine whether milestones or other variable consideration, except for royalties and sales-based milestones, should be included in the transaction price as described below. We recognize revenue based on those amounts when, or as, the performance obligations under the contract are satisfied.
We utilize judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. The measure of progress, and the resulting periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the arrangement, which are subject to review by the joint steering committee, or JSC. Such a change could have a material impact on the amount of revenue we record in future periods. We concluded that the transfer of control to the customer for the performance obligation occurs over the time period that the research and development services are provided by us. We recognize revenue for the performance obligation as those services are provided using an input method, based on the cumulative costs incurred compared to the total estimated costs expected to be incurred to satisfy the performance obligation. The cost-to-cost method is, in management's judgment, the best measure of progress towards satisfying the performance condition.
At the inception of each arrangement that includes research, development or regulatory milestone payments, we evaluate whether the milestones are considered likely to be met and estimate the amount to be considered for inclusion in the transaction price using the most-likely-amount method. If it is probable that a significant reversal in the amount of cumulative revenue recognized would not occur, the associated milestone value is included in the transaction price. For milestone payments due upon events that are not within our control, such as regulatory approvals, we are not able to assert that it is likely that the regulatory approval will be granted and that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur until those approvals are received. In making this assessment, we evaluate factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone. There is considerable judgment involved in determining whether it is probable that a significant reversal in the amount of cumulative revenue recognized would not occur.
We reevaluate the transaction price and our total estimated costs expected to be incurred at the end of each reporting period and as uncertain events, such as changes to the expected timing and cost of certain research, development and manufacturing activities that we are responsible for, are resolved or other changes in circumstances occur. If necessary, we will adjust our estimate of the transaction price or our estimates of the total costs expected to be incurred. To date, we have not had any significant changes in our estimates.
Accrued research and development expenses
As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to us at that time. At each period end, we corroborate the accuracy of these estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued research and development expenses include those related to fees paid to:
•
Vendors in connection with discovery and preclinical development activities;
•
CROs in connection with preclinical and clinical studies and testing; and
•
CMOs in connection with the process development and scale up activities and the production of materials.
We record the expense and accrual related to contract research and manufacturing based on our estimates of the services received and efforts expended considering a number of factors, including our knowledge of the progress towards completion of the research, development, and manufacturing activities; invoicing to date under contracts; communication from the contract research organizations, contract manufacturing organizations and other companies of any actual costs incurred during the period that have not yet been invoiced; and the costs included in the contracts and purchase orders. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.
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Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K.
Emerging Growth Company and Smaller Reporting Company Status
The Jumpstart Our Business Startups Act of 2012 permits an "emerging growth company" such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies 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 emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
We are also a "smaller reporting company", meaning that the market value of our
stock held by non-affiliates plus the aggregate amount of gross proceeds to us
as a result of the IPO is less than
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