Syndax(SNDX) - 2020 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents the company's unaudited financial statements, management's discussion, market risk, and internal controls Item 1. Unaudited Financial Statements This section presents Syndax Pharmaceuticals' unaudited condensed consolidated financial statements and accompanying notes Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity | Metric (in thousands) | June 30, 2020 | December 31, 2019 | Change ($) | Change (%) | | :-------------------- | :------------ | :---------------- | :--------- | :--------- | | ASSETS | | | | | | Cash and cash equivalents | $53,611 | $24,609 | $29,002 | 117.85% | | Short-term investments | $133,142 | $35,166 | $97,976 | 278.61% | | Total current assets | $191,807 | $62,331 | $129,476 | 207.71% | | Total assets | $192,628 | $63,525 | $129,103 | 203.23% | | LIABILITIES | | | | | | Total current liabilities | $12,467 | $18,368 | $(5,901) | -32.13% | | Loan payable | $19,896 | $— | $19,896 | N/A | | Total liabilities | $44,981 | $31,925 | $13,056 | 40.89% | | STOCKHOLDERS' EQUITY | | | | | | Total stockholders' equity | $147,647 | $31,600 | $116,047 | 367.24% | Condensed Consolidated Statements of Comprehensive Loss This section details the company's revenues, expenses, and net loss for the reported periods | Metric (in thousands) | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Change ($) | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Total revenues | $379 | $379 | $0 | 0.00% | | Research and development | $10,943 | $12,290 | $(1,347) | -10.96% | | General and administrative | $6,046 | $3,463 | $2,583 | 74.59% | | Total operating expenses | $16,989 | $15,753 | $1,236 | 7.85% | | Net loss | $(17,062) | $(14,916) | $(2,146) | 14.39% | | Net loss per share (basic and diluted) | $(0.42) | $(0.47) | $0.05 | -10.64% | | Metric (in thousands) | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | Change ($) | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Total revenues | $758 | $758 | $0 | 0.00% | | Research and development | $20,505 | $23,569 | $(3,064) | -12.99% | | General and administrative | $11,963 | $7,374 | $4,589 | 62.23% | | Total operating expenses | $32,468 | $30,943 | $1,525 | 4.93% | | Net loss | $(32,298) | $(29,218) | $(3,080) | 10.54% | | Net loss per share (basic and diluted) | $(0.97) | $(1.00) | $0.03 | -3.00% | Condensed Consolidated Statements of Cash Flows This section outlines the company's cash inflows and outflows from operating, investing, and financing activities | Metric (in thousands) | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | Change ($) | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(37,332) | $(29,356) | $(7,976) | 27.17% | | Net cash used in investing activities | $(97,665) | $(6,179) | $(91,486) | 1480.50% | | Net cash provided by financing activities | $163,999 | $28,432 | $135,567 | 476.03% | | Net increase (decrease) in cash, cash equivalents and restricted cash | $29,002 | $(7,103) | $36,105 | -508.30% | | Cash, cash equivalents and restricted cash — end of period | $53,726 | $26,882 | $26,844 | 99.86% | Notes to Condensed Consolidated Financial Statements This section provides detailed explanations of accounting policies, revenue recognition, and significant agreements - Syndax Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing cancer therapies, operating as a single segment[19] - The company's financial statements are prepared in accordance with U.S. GAAP, with certain information condensed or omitted for interim reporting. The results for the three and six months ended June 30, 2020, are not indicative of future periods[20] - The COVID-19 pandemic has led to business continuity plans and is anticipated to impact clinical development timelines, manufacturing, and regulatory efforts, potentially having a material adverse effect on the business[23][24] - Revenue is solely derived from a license agreement with Kyowa Kirin Co., Ltd. (KKC) for entinostat in Japan and Korea, with a $17.3 million upfront payment recognized ratably through 2029[29][30][33] | Metric (in thousands, except share data) | June 30, 2020 | December 31, 2019 | | :--------------------------------------- | :------------ | :---------------- | | Options to purchase common stock | 6,857,741 | 5,770,616 | | Warrants to purchase common stock | 1,105,908 | 4,595,039 | | Employee Stock Purchase Plan | 24,214 | 18,848 | | Non-vested restricted stock units (RSUs) | 15,000 | — | - Significant agreements include licenses for Menin Assets (AbbVie License Agreement), axatilimab (UCB License Agreement), and entinostat (ECOG Agreement, Bayer Agreement). The E2112 trial for entinostat did not meet its primary endpoint, leading to deprioritization of the program[38][39][43][45] | Asset (in thousands) | June 30, 2020 | December 31, 2019 | | :------------------- | :------------ | :---------------- | | Cash and cash equivalents | $53,611 | $24,609 | | Short-term investments | $133,142 | $35,166 | | Total assets at fair value | $186,753 | $59,775 | | Expense (in thousands) | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $561 | $537 | $1,093 | $1,071 | | General and administrative | $1,568 | $801 | $2,866 | $1,859 | | Total stock-based compensation | $2,129 | $1,338 | $3,959 | $2,930 | - In February 2020, the company entered into a loan and security agreement with Hercules Capital, Inc. for up to $30.0 million, with an initial advance of $20.0 million. The loan bears interest at an annual rate of 9.85% as of June 30, 2020, and is collateralized by substantially all company assets excluding intellectual property[62][64] | Metric (in thousands, except share data) | Balance as of December 31, 2019 | Balance as of June 30, 2020 | | :--------------------------------------- | :------------------------------ | :-------------------------- | | Common Stock Shares | 27,140,484 | 38,512,744 | | Common Stock Amount | $3 | $4 | | Additional Paid-In Capital | $527,067 | $675,294 | | Accumulated Deficit | $(495,470) | $(527,768) | | Total Stockholders' Equity | $31,600 | $147,647 | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial performance, clinical progress, COVID-19 impact, and liquidity Company Overview This section provides an overview of Syndax Pharmaceuticals' business, lead candidates, and financial position - Syndax Pharmaceuticals is a clinical-stage biopharmaceutical company developing cancer therapies, with lead candidates SNDX-5613 and axatilimab. The entinostat program has been deprioritized[84] - The company has no approved products or product revenues and has incurred continuous losses since inception, with a net loss of $32.3 million for the six months ended June 30, 2020, and an accumulated deficit of $527.8 million[85] - As of June 30, 2020, cash, cash equivalents, and short-term investments totaled $186.8 million[85] - The COVID-19 pandemic has not yet impacted financial guidance or clinical data timelines for 2020, but the company continues to monitor its potential effects[86] Clinical Developments This section details the progress of SNDX-5613 and axatilimab trials and the deprioritization of entinostat - For SNDX-5613, the FDA agreed to enhancements for the Phase 1 portion of the AUGMENT-101 trial, focusing enrollment on MLL-r and NPM1 mutant acute leukemias and expanding pediatric patient enrollment. A Phase 2 dose is expected by end of 2020, with full Phase 1 data in early 2021. SNDX-5613 received Orphan Drug Designation for adult and pediatric AML[87][88] - For axatilimab, enrollment continues in the Phase 1/2 trial for chronic graft versus host disease (cGVHD), with additional Phase 1 results expected in Q4 2020. Phase 1 data in solid tumors showed good tolerability and depletion of pro-inflammatory monocytes[91][92] - The E2112 Phase 3 trial for entinostat in HR+, HER2- breast cancer did not meet its primary endpoint of statistically significant overall survival benefit, leading to the deprioritization of the entinostat program[94] COVID-19 Business Update This section outlines the company's response to COVID-19 and its potential impacts on operations and finances - The company implemented business continuity plans due to COVID-19, transitioning to remote work. While no immediate financial impacts are observed, the pandemic could materially adversely affect business, financial condition, results of operations, and growth prospects[95] - Supply chain for SNDX-5613 and axatilimab is currently adequate for 2020, but prolonged disruptions could cause delays in manufacturing and clinical trials[96] - Clinical development may face disruptions or delays in trial site initiation, patient enrollment, and assessments due to COVID-19, potentially impacting timelines and interactions with regulatory bodies[97] - The company has sufficient liquidity for the next 12 months but acknowledges that the evolving COVID-19 pandemic could hinder access to additional capital, negatively affecting future operations[98] Financial Overview This section summarizes the company's revenue sources, expense drivers, and interest income/expense - Revenue is solely from the KKC license agreement for entinostat in Japan and Korea, with a $17.3 million upfront payment recognized ratably through 2029[100] - Research and development expenses are central to the business, primarily for product candidate development, and are expected to increase as candidates advance. From inception through June 30, 2020, R&D expenses totaled $275.2 million[102][103] - General and administrative expenses are expected to increase with headcount and pre-commercialization activities[106] - Interest expense primarily relates to the term loan, while interest income is earned on cash, cash equivalents, and short-term investments[107][108] Results of Operations This section analyzes the changes in revenues, operating expenses, and net loss for the reported periods | Metric (in thousands) | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Change ($) | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | License fees | $379 | $379 | $0 | 0% | | Research and development | $10,943 | $12,290 | $(1,347) | -11% | | General and administrative | $6,046 | $3,463 | $2,583 | 75% | | Net loss | $(17,062) | $(14,916) | $(2,146) | 14% | - The decrease in R&D expenses for the three months ended June 30, 2020, was primarily due to a $1.9 million decrease in clinical activities, partially offset by a $0.6 million increase in professional fees. This includes reduced ENCORE program activities ($0.3 million) and a $4.0 million expense in 2019 for Menin program milestones, partially offset by increased SNDX-5613 ($1.7 million) and axatilimab ($0.7 million) clinical activities[114] - General and administrative expenses increased by $2.5 million (75%) for the three months ended June 30, 2020, driven by $1.2 million in pre-commercialization activities, $1.1 million in employee expenses (including $0.8 million in stock compensation), and $0.2 million in director's and officer's insurance[116] | Metric (in thousands) | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | Change ($) | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | License fees | $758 | $758 | $0 | 0% | | Research and development | $20,505 | $23,569 | $(3,064) | -13% | | General and administrative | $11,963 | $7,374 | $4,589 | 62% | | Net loss | $(32,298) | $(29,218) | $(3,080) | 11% | - The decrease in R&D expenses for the six months ended June 30, 2020, was primarily due to a $0.4 million decrease in employee compensation and a $2.8 million decrease in ENCORE clinical programs, offset by increased professional fees ($0.8 million), axatilimab activities ($0.7 million), and Menin program activities ($2.6 million). A $4.0 million Menin milestone expense was recognized in 2019[121] - General and administrative expenses increased by $4.6 million (62%) for the six months ended June 30, 2020, mainly due to $2.2 million in pre-commercialization activities, $0.2 million in legal/professional fees, $0.4 million in D&O insurance, and $1.8 million in employee compensation (including $1.0 million in stock compensation)[123] Liquidity and Capital Resources This section details the company's cash position, capital raising activities, and future funding requirements - As of June 30, 2020, the company had $186.8 million in cash, cash equivalents, and short-term investments, expected to fund operations for at least the next 12 months[126] - In May 2020, the company sold 6,388,889 shares of common stock for net proceeds of approximately $107.9 million[127] - In January 2020, the company sold 3,036,719 shares of common stock and pre-funded warrants for gross proceeds of approximately $35.0 million. This offering triggered a downward adjustment in the exercise price of Series 1 and Series 2 warrants[128][129] - The COVID-19 pandemic poses a risk to accessing additional capital if market disruptions persist[130] - A loan and security agreement with Hercules Capital, Inc. provides for up to $30.0 million, with $20.0 million funded in February 2020, bearing interest at 9.85% as of June 30, 2020. The loan is collateralized by most company assets, excluding intellectual property[131] - The company has an At-the-Market (ATM) offering program with Cowen and Company, LLC, allowing for the sale of up to $50.0 million in common stock, with $50.0 million remaining available as of June 30, 2020[132] - Future funding requirements are substantial and depend on clinical trial progress, regulatory approvals, intellectual property costs, market acceptance, manufacturing, and commercialization efforts. The company anticipates continued significant losses and will need additional capital through equity, debt, or collaborations[134][136][137] | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | Change ($) | Change (%) | | :-------------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(37,332) | $(29,356) | $(7,976) | 27.17% | | Net cash used in investing activities | $(97,665) | $(6,179) | $(91,486) | 1480.50% | | Net cash provided by financing activities | $163,999 | $28,432 | $135,567 | 476.03% | - Net cash used in operating activities increased to $37.3 million for the six months ended June 30, 2020, primarily due to a higher net loss and a net decrease in operating assets and liabilities[139] - Net cash used in investing activities significantly increased to $97.7 million for the six months ended June 30, 2020, mainly due to $131.1 million in purchases of available-for-sale marketable securities, partially offset by $33.4 million from maturities[142] - Net cash provided by financing activities surged to $164.0 million for the six months ended June 30, 2020, driven by $142.8 million from direct and follow-on offerings and $19.7 million from the term loan[144] - The company has no off-balance sheet arrangements[148] - The company has irrevocably elected not to use the extended transition period for complying with new or revised accounting standards under the JOBS Act[150] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section assesses the company's exposure to market risk, primarily interest rate sensitivity on investments and debt - As of June 30, 2020, the company held $53.6 million in cash and cash equivalents and $133.1 million in short-term investments, primarily exposed to interest rate sensitivity[151] - An immediate 100 basis point change in interest rates would not materially affect the fair market value of cash equivalents and short-term investments due to their short-term maturities and low-risk profile[151] - The $20.0 million loan payable accrues interest at a variable rate (greater of 9.85% or 5.10% plus Wall Street Journal prime rate). A 100 basis point adverse change in market interest rates could increase interest expense by approximately $0.5 million[152] Item 4. Controls and Procedures Management evaluated the effectiveness of disclosure controls and internal control over financial reporting - As of June 30, 2020, management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective at the reasonable assurance level[155] - No material changes in internal control over financial reporting occurred during the most recent fiscal quarter, and the company has not experienced a material impact on internal controls despite employees working remotely due to COVID-19[156] PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, and a list of exhibits Item 1. Legal Proceedings This section confirms the absence of material legal or arbitration proceedings against the company - As of June 30, 2020, the company was not involved in any material legal or arbitration proceedings, and no governmental proceedings were pending or contemplated[159] Item 1A. Risk Factors This section outlines significant risks impacting the company's business, financial condition, and future growth Risks Related to Our Business and Industry This section details risks concerning clinical trials, regulatory approvals, competition, and the COVID-19 pandemic - The COVID-19 pandemic could adversely impact business operations, including clinical trials, supply chain, and access to capital, potentially causing delays and negative financial effects[162][163][164][165][166] - The company may incur additional costs or delays in developing and commercializing product candidates, as clinical testing is expensive, lengthy, and uncertain, as demonstrated by the E2112 trial's failure for entinostat[168] - The company lacks internal sales, marketing, and distribution infrastructure, requiring significant investment or reliance on third parties, which could limit control and revenue potential[169][170] - Successful commercialization of product candidates depends on obtaining regulatory approvals, which is a lengthy and unpredictable process, and failure to do so would significantly harm business prospects[171][174] - Clinical testing for SNDX-5613 and axatilimab is limited, and there's no guarantee of demonstrating sufficient safety and efficacy to warrant continued development or regulatory approval[175][177] - Interim clinical trial data may change as more patient data become available and are subject to audit, potentially differing materially from preliminary results[178] - Inability to enroll patients in clinical trials due to factors like the COVID-19 pandemic, competition, or patient eligibility criteria could delay or prevent trial completion[180] - Reliance on sublicensees (KKC, Eddingpharm) and licensors (UCB, Bayer, Vitae/AbbVie) means their actions or non-compliance could adversely affect the development and commercialization of entinostat, axatilimab, and SNDX-5613, potentially leading to loss of license rights[181][182][265][269][274] - Strategic collaborations may not materialize or succeed, potentially requiring substantial resources, diluting existing stockholders, or leading to disputes and delays[183][185] - Even if approved, product candidates may not achieve adequate market acceptance due to efficacy/safety profiles, competition, pricing, reimbursement issues, or unfavorable publicity[190][191] - Dependence on third-party manufacturers for clinical and commercial drug supplies exposes the company to risks of non-compliance with cGMPs, manufacturing capacity issues, and regulatory approval delays[192][193][194] - Post-approval, products remain subject to ongoing regulatory requirements, and new safety information or manufacturing issues could lead to restrictions, withdrawals, or costly post-marketing studies[195][196] - Advertising and promotion are heavily scrutinized, and impermissible off-label promotion could lead to significant civil and criminal sanctions, fines, and exclusion from healthcare programs[198][199][200] - Undesirable side effects from product candidates could delay or prevent regulatory approval, limit commercial scope, or result in significant negative consequences post-marketing, including product liability claims[201][202][223][224] - Failure to obtain regulatory approval in international jurisdictions would prevent marketing outside the U.S., reducing the target market and harming commercial potential[203] - The company faces significant competition from biotechnology and pharmaceutical companies with greater resources and experience, potentially rendering its product candidates obsolete or non-competitive[204][205][206][207] - Employee misconduct, including insider trading or non-compliance with regulatory standards, could lead to significant fines, sanctions, and reputational harm[209][210] - Failure to attract and retain highly skilled employees, particularly at the management level, could adversely affect the ability to execute business plans[211][212] - Unfavorable pricing regulations or third-party coverage/reimbursement practices could harm business, as coverage and adequate reimbursement are crucial for commercial success and are subject to significant delays and limitations[213][214][215][216][217][218] - Current and future healthcare legislation (e.g., Affordable Care Act, CARES Act, drug pricing proposals) could increase commercialization costs, delay approvals, and reduce prices, negatively impacting future revenues[219][220][221][222] - Relationships with customers and payors are subject to anti-kickback, fraud and abuse, transparency, and privacy laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, Sunshine Act), non-compliance with which could lead to criminal sanctions, civil penalties, and exclusion from government programs[225][227][228][229] - Significant disruptions to IT systems or data security incidents, including those exacerbated by remote work due to COVID-19, could result in financial, legal, regulatory, business, and reputational harm[230][231][232][233] Risks Related to Our Financial Position and Capital Needs This section addresses risks related to historical losses, future funding requirements, and debt obligations - The company has incurred substantial net losses since inception, with a $32.3 million net loss for the six months ended June 30, 2020, and an accumulated deficit of $527.8 million, and expects to continue incurring losses[235][236] - Without product revenue, profitability depends on successful commercialization, which is uncertain and requires significant future expenses for development, regulatory approval, and market launch[237][238][239][240] - Additional capital will be required to finance planned operations, and if not available on acceptable terms, the company may have to delay or discontinue product development, seek less favorable strategic alliances, or relinquish technology rights[241][242][244][245] - The loan and security agreement with Hercules Capital, Inc. imposes restrictions on operating and financial flexibility, and a default could lead to accelerated repayment obligations and harm business prospects[246][247] - Changes in tax laws or regulations, such as the Tax Cuts and Jobs Act or the CARES Act, could adversely affect the company's tax expense and financial condition[248][249] - The company's ability to use net operating loss (NOL) carryforwards and other tax attributes may be limited due to past or future ownership changes, potentially increasing future tax liability[250] Risks Related to Intellectual Property This section covers risks associated with obtaining, protecting, and enforcing intellectual property rights - Failure to obtain or protect intellectual property rights, including patents, could impair the company's ability to compete effectively. Patent prosecution is expensive, time-consuming, and uncertain, with risks of narrow claims, prior art, and challenges to validity[252][253][254][255] - Patents for product candidates might expire before or shortly after commercialization, limiting exclusivity. For entinostat, the composition of matter patent expired in 2017, and the crystalline polymorph B patent expires in 2029, but competitors could develop non-infringing forms[256][257][258] - Patent applications for axatilimab and SNDX-5613 are pending, with no guarantee of issuance or broad coverage, and expected expiration dates in 2034 and 2037, respectively[259][260] - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may offer less protection, making it difficult to prevent infringement or marketing of competing products[261][262][263][264] - Changes in patent law, such as those from the America Invents Act, could increase uncertainties and costs in patent prosecution and enforcement, potentially weakening the ability to protect product candidates[278][279][280] - Non-compliance with procedural requirements for patent maintenance and application could lead to abandonment or lapse of patent rights[281] - Involvement in intellectual property lawsuits, whether to protect or defend rights, could be expensive, time-consuming, and unsuccessful, diverting management resources and potentially leading to loss of rights or monetary damages[282][283][284][285][286][287] - Claims of misappropriation of intellectual property from former employers or ownership by inventors could lead to litigation, loss of rights, or substantial costs[288][289][290] - Inability to protect confidential information and trade secrets, despite non-disclosure agreements, would harm the company's business and competitive position[291][292] Risks Related to Ownership of Our Common Stock This section discusses risks concerning stock price volatility, dilution, and corporate governance matters - The market price of the company's common stock is highly volatile and subject to wide fluctuations due to various factors, including clinical trial results, regulatory actions, competition, and general market conditions, potentially leading to loss of investment[294] - Future equity or debt offerings to fund operations may result in dilution to existing stockholders and/or increased fixed payment obligations. As of June 30, 2020, the company had significant shares issuable from warrants and an ATM program[295][296][297][298] - Lack of research coverage by securities analysts or adverse opinions could negatively impact stock price and trading volume[299] - Principal stockholders and management own a significant percentage (49.2% as of June 30, 2020) of voting stock, allowing them to exert significant influence over stockholder approval matters, potentially not aligning with other stockholders' interests[300] - As an 'emerging growth company' and 'smaller reporting company,' the company may avail itself of reduced disclosure requirements, which could make its common stock less attractive to investors and increase stock price volatility[301][302][303][304] - Operating as a public company incurs significant legal, accounting, and other expenses, and management dedicates substantial time to compliance initiatives[305] - Sales of a substantial number of common stock shares in the public market, including through the ATM program, could cause the stock price to fall[306] - The company may be subject to expensive securities litigation, which could divert management attention and harm the business[307] - Failure to maintain an effective system of internal control over financial reporting could adversely affect investor confidence and stock value, and compliance with Sarbanes-Oxley Act Section 404 requires substantial expense and management effort[308] - Provisions in charter documents and Delaware law (e.g., classified board, prohibition on written consent, ability to issue preferred stock, Section 203 of DGCL) may have anti-takeover effects, discouraging acquisitions or making it difficult to replace management[309][310] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports no unregistered sales of equity securities or use of proceeds for the period - There were no unregistered sales of equity securities or use of proceeds to report[311] Item 3. Defaults upon Senior Securities This section confirms no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[312] Item 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including key agreements and certifications - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Form of Pre-Funded Warrant, Amendment No. 12 to Clinical Trial Agreement with ECOG-ACRIN, Certifications of Principal Executive and Financial Officers, and Financial statements in iXBRL format[314]