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MarketScreener Homepage  >  Equities  >  Deutsche Boerse AG  >  ATyr Pharma    471A

ATYR PHARMA

(471A)
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Delayed Quote. Delayed Deutsche Boerse AG - 08/23 02:15:30 am
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ATYR PHARMA : Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)

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08/14/2019 | 04:58pm EDT

The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the consolidated financial statements and accompanying notes thereto for the fiscal year ended December 31, 2018 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, which are contained in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or SEC, on March 26, 2019.

This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended or the Exchange Act. Such forward looking statements, which represent our intent, belief or current expectations, involve risks and uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "expect," "anticipate," "estimate," "intend," "plan," "predict," "potential," "believe," "should" and similar expressions. Factors that could cause or contribute to differences in results include, but are not limited to those set forth under "Risk Factors" under Item 1A of Part II below, and elsewhere in this Quarterly Report on Form 10-Q. Except as required by law we undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.

Overview

We are a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways. We have concentrated our research and development efforts on a newly discovered area of biology, the extracellular functionality of tRNA synthetases. Built on more than a decade of foundational science on extracellular tRNA synthetase biology and its effect on immune responses, we have built a global intellectual property estate directed to all 20 human tRNA synthetases.




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Within our synthetase platform, we are primarily focused on the therapeutic translation of the Resokine pathway, comprised of extracellular proteins derived from the histidyl tRNA synthetase (HARS) gene family, one of the 20 tRNA synthetase genes. Our clinical stage product candidate, ATYR1923, is a fusion protein comprised of the immuno-modulatory domain of HARS fused to the FC region of a human antibody. ATYR1923 is also a selective modulator of Neuropilin-2 (NRP2) that downregulates the innate and adaptive immune response in inflammatory disease states. We are developing ATYR1923 as a potential therapeutic for patients with interstitial lung diseases (ILDs), a group of immune-mediated disorders that cause progressive fibrosis of the lung tissue. We selected pulmonary sarcoidosis as our first ILD indication and we are currently enrolling a Phase 1b/2a proof-of-concept clinical trial. The study has been designed to evaluate the safety, tolerability and immunogenicity of multiple doses of ATYR1923 and to evaluate established clinical endpoints and certain biomarkers to assess preliminary activity of ATYR1923. The results of this study will guide future development of ATYR1923 in pulmonary sarcoidosis and provide insight for the potential of ATYR1923 in other ILDs, such as chronic hypersensitivity pneumonitis and connective tissue disease ILD.

In conjunction with our clinical development of ATYR1923, we have in parallel been expanding our knowledge of tRNA synthetases and NRP2 biology through both industry and academic collaborations. In March 2019, we entered into a research collaboration and option agreement with CSL Behring for the development of product candidates derived from up to four tRNA synthetases from our preclinical pipeline. Under the terms of the collaboration, CSL Behring will fund all research and development activities and will pay a total of $4.25 million per synthetase program ($17 million if all four synthetase programs advance) in option fees based on achievement of research milestones and CSL's determination to continue development. We are also working closely with other collaborators and academia to further research in these areas.

Since our inception in 2005, we have devoted substantially all of our resources to the therapeutic potential of tRNA synthetase biology, including the preclinical development of and clinical trials for our product candidates, the creation, licensing and protection of related intellectual property and the provision of general and administrative support for these operations. We have not generated any revenue from product sales and, through June 30, 2019, have funded our operations primarily through the sales of equity securities and convertible debt and through venture debt and term loans.

In April 2019, we entered into a securities purchase agreement (Purchase Agreement) with an institutional investor, The Federated Kaufmann Small Cap Fund, and Paul Schimmel, Ph.D., a member of our board of directors, relating to the issuance and sale of 660,154 shares of our common stock. The shares of common stock were sold in a registered direct offering at a purchase price of $7.57 per share for gross proceeds of approximately $5.0 million.

In June 2016, we entered into a sales agreement with Cowen and Company, LLC (Cowen) for at the market offerings (ATM Offering Program), under which we were able to offer and sell shares of our common stock having an aggregate offering price of up to $35.0 million from time to time. In April 2019, we suspended and terminated the prospectus supplement and in May 2019, we terminated the ATM Offering Program with Cowen. Under the ATM Offering Program with Cowen, we sold an aggregate of 243,393 shares of common stock at an average price of $7.88 per common share for net proceeds of $1.8 million.

In June 2019, we entered into a sales agreement with H.C. Wainwright & Co., LLC (Wainwright) to create an ATM Offering Program under which we may offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million. Wainwright is entitled to a commission at a fixed commission rate equal to 3% of the gross proceeds. Under the ATM Offering Program with Wainwright, we have sold an aggregate of 611,687 shares of common stock at an average price of $5.43 per common share for net proceeds of $3.0 million.

We have never been profitable and have incurred net losses in each annual and quarterly period since our inception. For the six months ended June 30, 2019 and 2018, we have incurred consolidated net losses of $12.0 million and $21.1 million, respectively. As of June 30, 2019, we had an accumulated deficit of $310.7 million.

Financial Operations Overview

Organization and Business; Principles of Consolidation

We conduct substantially all of our activities through aTyr Pharma, Inc., a Delaware corporation, at our facility in San Diego, California. aTyr Pharma, Inc. was incorporated in the State of Delaware in September 2005. The condensed consolidated financial statements include our accounts and our 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma Limited as of June 30, 2019. All intercompany transactions and balances are eliminated in consolidation.




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Leases

On January 1, 2019, we adopted Accounting Standards Update (ASU) No. 2016­02, Leases (Topic 842) (ASU No. 2016-02). For our long-term operating leases, we recognized a right-of-use asset and a lease liability in our condensed consolidated balance sheets. The lease liability is determined as the present value of future lease payments using an estimated rate of interest that we would pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. We determined the lease term at the commencement date by considering whether renewal options and termination options are reasonably assured of exercise.

We elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to exclude from our condensed consolidated balance sheets recognition of leases having a term of 12 months or less (short-term leases) and we elected to not separate lease components and non-lease components for our long-term leases.

Rent expense for the operating lease is recognized on a straight-line basis over the lease term and is included in operating expenses in our condensed consolidated statements of operations.

Prior period amounts continue to be reported in accordance with our historic accounting practices under previous lease guidance, Accounting Standards Codification (ASC) 840, Leases. See "-Recent Accounting Pronouncements" below, for more information about the impact of the adoption on ASU No. 2016-02.

Revenue Recognition

We have entered into a research collaboration and option agreement. The terms of this arrangement include payments to us for research and development services and potential development milestone payments.

We evaluate our agreements under ASC 606, Revenue from Contracts with Customers (Topic 606) and ASC 808, Collaborative Arrangements (Topic 808). We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreement, we perform the following 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 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. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. We use key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.

Research and Development Expenses

To date, our research and development expenses have related primarily to the development of, and clinical trials for, our product candidates, and to research efforts targeting the potential therapeutic application of other tRNA synthetase-based immuno-modulators (including funding of our former research collaborations with The Scripps Research Institute) and, more recently research efforts related to NRP2 biology. These expenses consist primarily of:

    •   salaries and employee-related expenses, including stock-based compensation
        and benefits for personnel in research and product development functions;


    •   costs associated with conducting our preclinical, development and
        regulatory activities, including fees paid to third-party professional
        consultants, service providers and our scientific, therapeutic and
        clinical advisory board;


    •   costs to acquire, develop and manufacture preclinical study and clinical
        trial materials;


    •   costs incurred under clinical trial agreements with clinical research
        organizations (CROs) and investigative sites;


  • costs for laboratory supplies; and


  • allocated facilities, depreciation and other allocable expenses.

Research and development costs are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from our external service providers. We adjust our accrual as actual costs become known.




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Product candidates in later stages of clinical development 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. We expect that the levels of our research and development expenses will increase in the current year and will consist primarily of costs related to the advancement of our ATYR1923 program into a Phase 1b/2a clinical trial and research, and other potential therapeutics based on our tRNA synthetase biology and NRP2 biology.

We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates. At this time, due to the inherently unpredictable nature of preclinical and clinical development and given the early stage of our programs, we are unable to estimate with any certainty the costs we will incur or the timelines we will require in the continued development of our product candidates. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate's commercial potential. In addition, we cannot forecast which programs or product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, corporate development and administrative support functions, including stock-based compensation expenses and benefits. Other significant general and administrative expenses include accounting, legal services, expenses associated with applying for and maintaining patents, cost of insurance, cost of various consultants, occupancy costs, information systems costs and depreciation.

Other Income (Expense)

Other income (expense), net consists primarily of interest income earned on cash and cash equivalents and available-for-sale investments and interest expense on our loans outstanding with Silicon Valley Bank (SVB) and Solar Capital Ltd. (Solar, and together with SVB, the Lenders) as discussed below.

Critical Accounting Policies and Significant Judgments and Estimates

Our management's discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements, as well as the reported expenses during the reporting periods. We monitor and analyze these items for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on our historical experience and on various other factors we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.

There have been no significant changes to our critical accounting policies since December 31, 2018, with the exception of changes made upon adoption of ASU No. 2016-02 and the related supplemental ASUs. For a description of critical accounting policies that affect our significant judgments and estimates used in the preparation of our consolidated financial statements, refer to Item 7 in Management's Discussion and Analysis of Financial Condition and Results of Operations and Note 1 to our financial statements contained in our Annual Report and Note 1 to our condensed financial statements contained in this quarterly report on Form 10-Q.

Results of Operations

Comparison of the Three Months Ended June 30, 2019 and 2018

The following table summarizes our results of operations for the three months ended June 30, 2019 and 2018 (in thousands):


                                         Three Months Ended June 30,         Increase /
                                          2019               2018            (Decrease)

Research and development expenses $ 3,314 $ 6,484 $ (3,170 )

 General and administrative expenses        2,421                 3,476           (1,055 )
 Other income (expense), net                 (207 )                (452 )            245






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Research and development expenses. Research and development expenses were $3.3 million and $6.5 million for the three months ended June 30, 2019 and 2018, respectively. The decrease of $3.2 million was due primarily to a $1.5 million decrease in personnel associated costs mainly as a result of the May 2018 reduction in force, a decrease of $0.5 million in costs associated with the research collaboration with The Scripps Research Institute which we terminated effective November 2018, a decrease of $0.3 million related to lower product manufacturing costs, and a $0.9 million decrease in research and development expenses which includes non-clinical studies.

General and administrative expenses. General and administrative expenses were at $2.4 million and $3.5 million for the three months ended June 30, 2019 and 2018, respectively. The decrease of $1.1 million was due primarily to a $0.8 million decrease in personnel associated costs mainly as a result of the May 2018 reduction in force, and a $0.3 million decrease in professional fees.

Other income (expense), net. Other expense was $0.2 million and $0.5 million for the three months ended June 30, 2019 and 2018, respectively. The $0.2 million decrease was primarily a result of lower balances on our loans with our Lenders which we started paying down in June 2018.

Comparison of the Six Months Ended June 30, 2019 and 2018

The following table summarizes our results of operations for the six months ended June 30, 2019 and 2018 (in thousands):




                                          Six Months Ended June 30,          Increase /
                                           2019               2018           (Decrease)

Research and development expenses $ 6,659$ 12,634$ (5,975 )

 General and administrative expenses          4,953               7,546           (2,593 )
 Other income (expense), net                   (467 )              (899 )           (432 )



Research and development expenses. Research and development expenses were $6.7 million and $12.6 million for the six months ended June 30, 2019 and 2018, respectively. The decrease of $6.0 million was due primarily to a $2.6 million decrease in personnel associated costs mainly as a result of the May 2018 reduction in force, a decrease of $1.0 million in costs associated with our research collaboration with The Scripps Research Institute which we terminated effective November 2018, a decrease of $0.7 million related to lower product manufacturing costs, and a $1.7 million decrease in research and development expenses which includes non-clinical studies.

General and administrative expenses. General and administrative expenses were at $5.0 million and $7.5 million for the six months ended June 30, 2019 and 2018, respectively. The decrease of $2.6 million was due primarily to a $1.9 million decrease in personnel associated costs mainly as a result of the May 2018 reduction in force, and a $0.7 million decrease in professional fees.

Other income (expense), net. Other expense was $0.5 million and $0.9 million for the six months ended June 30, 2019 and 2018, respectively. The $0.4 million decrease was primarily a result of lower balances on our loans with our Lenders which we started paying down in June 2018.

Liquidity and Capital Resources

We have incurred losses and negative cash flows from operations since our inception. As of June 30, 2019, we had an accumulated deficit of $310.7 million and we expect to continue to incur net losses for the foreseeable future. We believe that our existing cash, cash equivalents and available-for-sale investments of $42.4 million as of June 30, 2019, will be sufficient to meet our anticipated cash requirements for a period of one year from the filing date of this Quarterly Report.




Sources of Liquidity

From our inception through June 30, 2019, we have financed our operations primarily through the sale of equity securities, convertible debt, venture debt and term loans.




Equity Securities

In April 2019, we entered into a Purchase Agreement with an institutional investor, The Federated Kaufmann Small Cap Fund, and Paul Schimmel, Ph.D., a member of our board of directors, relating to the issuance and sale of 660,154 shares of our common stock. The shares of common stock were sold in a registered direct offering at a purchase price of $7.57 per share for gross proceeds of approximately $5.0 million.




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In June 2016, we entered into a sales agreement with Cowen for an ATM Offering Program, under which we were able to offer and sell shares of our common stock having an aggregate offering price of up to $35.0 million from time to time. In April 2019, we suspended and terminated the prospectus supplement related to our ATM Offering Program. In May 2019, we terminated the ATM Offering Program. Under the ATM Offering Program with Cowen, we sold an aggregate of 243,393 shares of common stock at an average price of $7.88 per common share for net proceeds of $1.8 million.

In June 2019, we entered into a sales agreement with Wainwright to create an ATM Offering Program under which we may offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million. Wainwright is entitled to a commission at a fixed commission rate equal to 3% of the gross proceeds. Under the ATM Offering Program with Wainwright, we have sold an aggregate of 611,687 shares of common stock at an average price of $5.43 per common share for net proceeds of $3.0 million.

Debt Financing

In November 2016, we entered into a loan and security agreement and subsequently entered amendments (collectively, the Loan Agreement), for term loans with the Lenders, to borrow up to $20.0 million issuable in three separate tranches (the Term Loans), $10.0 million of which was funded in November 2016, $5.0 million of which was funded in June 2017 and $5.0 million of which was funded in December 2017.

Under the Loan Agreement, we were obligated to make interest-only payments through June 1, 2018. Beginning June 2018, we were obligated to make consecutive equal monthly payments of principal and interest in arrears through the maturity date of November 18, 2020. Accordingly, we started paying the principal balance of the Term Loans in June 2018. The Term Loans bear interest at the prime rate, as reported in The Wall Street Journal on the last date of the month preceding the month in which interest will accrue, plus 4.10%. A final payment equal to 8.75% of the funded amounts is payable when the Term Loans become due or upon the prepayment of the respective outstanding balance. We have the option to prepay the outstanding balance of the loan in full, subject to a prepayment fee ranging from 1.0% to 3.0% depending upon when the prepayment occurs, including any non-usage fees.

Cash Flows

The following table sets forth a summary of the net cash flow activity for each of the periods indicated (in thousands):



                                               Six Months Ended June 30,
                                                 2019               2018
           Net cash (used in) provided by:
           Operating activities              $     (10,844 )$  (19,764 )
           Investing activities                     (1,064 )         18,576
           Financing activities                      3,453             (631 )
           Net decrease in cash              $      (8,455 )$   (1,819 )

Operating activities. Net cash used in operating activities was $10.8 million and $19.8 million for the six months ended June 30, 2019 and 2018, respectively. Net cash used in operating activities for the six months ended June 30, 2019 was primarily related to our net loss of $12.0 million, adjusted for non-cash stock-based compensation expense of $1.1 million and net cash outflows from the changes in our operating assets and liabilities of $0.8 million. Net cash used in operating activities for the six months ended June 30, 2018 was primarily related to our net loss of $21.1 million, adjusted for non-cash stock-based compensation expense of $2.1 million and net cash outflows from the changes in our operating assets and liabilities of $1.6 million.

Investing activities. Net cash used in investing activities for the six months ended June 30, 2019 was primarily due to net purchases of investment securities of $1.1 million. Net cash provided by investing activities for the six months ended June 30, 2018 was primarily due to net maturities of investment securities $19.1 million. We invest cash in excess of our immediate operating requirements with various maturities to optimize our return on investment while satisfying our liquidity needs. Cash required for our immediate operating needs during the six months ended June 30, 2019 was less than our immediate operating requirements during the six months ended June 30, 2018.

Financing activities. Net cash provided in financing activities for the six months ended June 30, 2019 consisted of $4.9 million proceeds from issuance of common stock through a registered direct offering, net of offering costs and $2.5 million proceeds from issuance of common stock through ATM Offering Programs, net of offering costs, offset by a $4.0 million repayment on our Term Loans. Net cash used in financing activities for the six months ended June 30, 2018 consisted of a $0.7 million repayment on our Term Loans.




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Funding Requirements

To date, we have not generated any revenues from product sales. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue to advance ATYR1923 in clinical development, continue our research and development activities with respect to other potential therapies based on our tRNA synthetase biology and NPR2 biology, and seek marketing approval for product candidates that we may develop. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. We currently have no sales or marketing capabilities and would need to expand our organization to support these activities. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.

Our future capital requirements are difficult to forecast and will depend on many factors, including:

     •   our ability to initiate, and the progress and results of, our current and
         planned clinical trials of ATYR1923;


     •   the scope, progress, results and costs of preclinical development, and
         clinical trials for other product candidates;


  • the manufacturing of preclinical study and clinical trial materials;


  • the costs, timing and outcome of regulatory review of our product candidates;


     •   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;


     •   the costs and timing of future commercialization activities, including
         product manufacturing, marketing, sales and distribution, for any of our
         product candidates for which we receive marketing approval; and


  • the extent to which we acquire or in-license other products and technologies.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic partnerships and/or licensing arrangements. To the extent we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, our other technologies, future revenue streams or research programs 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 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 our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Contractual Obligations and Commitments

We enter into contracts in the normal course of business with clinical trial sites and clinical supply manufacturing organizations and with vendors for preclinical safety and research studies, research supplies and other services and products purposes. These contracts generally provide for termination after a notice period, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments. Our contractual obligations have not materially changed outside the ordinary course of our business during the six months ended June 30, 2019, as compared to those disclosed in our Annual Report on Form 10-K filed for the year ending December 31, 2018.

Recent Accounting Pronouncements

For discussion of recently issued accounting pronouncements, refer to Item 1 of Part I, Notes to Condensed Consolidated Financial Statements (Unaudited) - Note 1 - Recent Accounting Pronouncements.

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 SEC.





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