Aldeyra Therapeutics(ALDX) - 2019 Q2 - Quarterly Report

Part I – FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Condensed Consolidated Financial Statements This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, and significant transactions Consolidated Balance Sheets This subsection provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates Consolidated Balance Sheet Highlights | Metric | June 30, 2019 (Unaudited) | December 31, 2018 | | :--------------------------- | :------------------------ | :---------------- | | Total Assets | $73,839,014 | $95,091,155 | | Total Liabilities | $6,505,644 | $8,473,176 | | Total Stockholders' Equity | $67,333,370 | $86,617,979 | | Cash and Cash Equivalents | $7,399,564 | $3,357,472 | | Marketable Securities | $30,057,408 | $46,242,220 | Consolidated Statements of Operations This subsection presents the company's financial performance over specific periods, including research and development, administrative expenses, and net loss Consolidated Statements of Operations Highlights | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $10,664,858 | $6,792,974 | $18,513,448 | $13,393,080 | | Acquired in-process R&D | $(49,848) | $0 | $6,547,703 | $0 | | General and administrative | $3,116,414 | $2,373,059 | $6,101,452 | $4,264,360 | | Loss from operations | $(13,731,424) | $(9,166,033) | $(31,162,603) | $(17,657,440) | | Net loss | $(13,327,165) | $(9,050,435) | $(28,951,193) | $(17,447,496) | | Net loss per share - basic and diluted | $(0.49) | $(0.46) | $(1.08) | $(0.88) | Consolidated Statements of Comprehensive Loss This subsection details the company's comprehensive loss, including net loss and other comprehensive income items like unrealized gains on securities Consolidated Statements of Comprehensive Loss Highlights | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(13,327,165) | $(9,050,435) | $(28,951,193) | $(17,447,496) | | Unrealized gain on marketable securities | $6,641 | $13,826 | $22,677 | $15,272 | | Comprehensive loss | $(13,320,524) | $(9,036,609) | $(28,928,516) | $(17,432,224) | Consolidated Statements of Stockholders' Equity This subsection outlines changes in stockholders' equity, including common shares, paid-in capital, accumulated deficit, and stock-based compensation Stockholders' Equity Changes | Metric | December 31, 2018 | June 30, 2019 | | :----------------------------------- | :---------------- | :------------ | | Common Shares Outstanding (shares) | 26,244,435 | 26,986,936 | | Additional Paid-in Capital | $225,136,127 | $234,779,291 | | Accumulated Deficit | $(138,535,168) | $(167,486,361) | | Total Stockholders' Equity | $86,617,979 | $67,333,370 | - Stock-based compensation for the six months ended June 30, 2019, was $3,981,052[11] - Issuance of common stock in connection with the Helio Vision, Inc. acquisition added $4,862,731 to total stockholders' equity for the six months ended June 30, 2019[11] Consolidated Statements of Cash Flows This subsection summarizes the company's cash inflows and outflows from operating, investing, and financing activities over specific periods Consolidated Statements of Cash Flows Highlights | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(25,442,857) | $(14,200,284) | | Net cash provided by investing activities | $17,086,480 | $5,658,088 | | Net cash provided by financing activities | $398,469 | $13,124,533 | | Net (decrease)/increase in cash | $(7,957,908) | $4,582,337 | | Cash and cash equivalents, end of period | $39,399,564 | $24,605,674 | Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements, covering accounting policies and significant events Nature of Business This note describes the company's primary business as developing next-generation medicines for immune-mediated diseases and its core activities - Aldeyra Therapeutics, Inc. is developing next-generation medicines to improve the lives of patients with immune-mediated diseases[18] - The company's principal activities include raising capital and research and development activities[18] Basis of Presentation This note explains the basis of financial statement preparation, management's assessment of liquidity, and future capital requirements - The interim unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and Form 10-Q[19] - Management believes current cash, cash equivalents, and marketable securities are adequate to fund anticipated operating expenses through the end of 2020, including planned Phase 3 clinical trials (RENEW and GUARD)[20] - Additional funding will be required in the future to carry out all planned research and development activities, commercialize product candidates, or conduct substantial additional development requested by the FDA[20] Helio Vision Acquisition This note details the acquisition of Helio Vision, Inc., including the issuance of common stock and the accounting treatment of acquired assets - On January 28, 2019, Aldeyra acquired Helio Vision, Inc., issuing 1,150,990 shares of common stock to former securityholders and an advisor[25] - The acquisition was accounted for as an asset acquisition, and the fair value of the acquired assets ($6.6 million) was fully expensed as in-process research and development due to their early stage and uncertain future use[27] - The acquisition resulted in an income tax benefit of $1.3 million due to a reduction in the company's valuation allowance[27] Net Loss Per Share This note explains the calculation of net loss per share and lists potentially dilutive securities, noting their non-dilutive effect due to net loss - Diluted weighted average common shares outstanding are equal to basic weighted average common shares due to the company's net loss position[29] Potentially Dilutive Securities Outstanding | Potentially Dilutive Securities | Three and Six Months Ended June 30, 2019 | Ended June 30, 2018 | | :------------------------------ | :--------------------------------------- | :------------------ | | Options to purchase common stock | 4,817,497 | 3,402,163 | | Restricted stock units | 430,425 | 212,297 | | Unvested restricted shares | 568,627 | — | | Total common stock equivalents | 5,816,549 | 3,674,460 | Cash, Cash Equivalents and Marketable Securities This note provides a breakdown of cash, cash equivalents, and marketable securities, including their carrying amounts and contractual maturities Cash, Cash Equivalents, and Marketable Securities Composition | Asset Category | June 30, 2019 (Carrying Amount) | December 31, 2018 (Carrying Amount) | | :------------------------------ | :------------------------------ | :---------------------------------- | | Cash | $1,963,104 | $2,127,175 | | Money market funds | $3,438,880 | $1,230,297 | | Reverse repurchase agreements | $32,000,000 | $44,000,000 | | U.S. government agency securities | $32,041,535 | $46,251,444 | | Total | $69,443,519 | $93,608,916 | - The contractual maturities of all available-for-sale securities were less than one year at June 30, 2019[31] Fair Value Measurements This note details the fair value hierarchy classifications for financial assets and confirms no liabilities were measured at fair value - Money market funds are classified as Level 1 inputs in the fair value hierarchy[34] - Reverse repurchase agreements and U.S. government agency securities are classified as Level 2 inputs[34] - There were no liabilities measured at fair value at June 30, 2019, or December 31, 2018[34] Accrued Expenses This note presents a detailed breakdown of accrued expenses, including compensation, research and development, and general and administrative costs Accrued Expenses Breakdown | Accrued Expense Category | June 30, 2019 | December 31, 2018 | | :--------------------------- | :------------ | :---------------- | | Accrued compensation | $1,012,314 | $1,172,880 | | Accrued research and development | $1,604,180 | $3,882,313 | | Accrued general & administrative | $787,295 | $366,305 | | Total Accrued Expenses | $3,403,789 | $5,421,498 | Credit Facility This note describes the company's term loan agreement with Hercules Capital, Inc., including the maximum amount and interest rate - In March 2019, the company entered into a Loan and Security Agreement with Hercules Capital, Inc. for a term loan of up to $60.0 million, secured by all company assets except intellectual property[37] - As of June 30, 2019, no amount was outstanding under the Hercules Credit Facility, as the company elected not to draw down the initial term loan advance[37] - The term loan bears interest at an annual rate equal to the greater of 9.10% or the prime rate plus 3.10%[39] Stockholders' Equity (Note 9) This note details common stock sales through the Jefferies Sales Agreement and the net proceeds generated during the period - From January 1, 2019, through June 30, 2019, the company sold 83,557 shares of common stock through the Jefferies Sales Agreement[41] - These sales generated $0.7 million in net proceeds after deducting commissions and other offering costs, at a volume-weighted average price of $10.73 per share[41] Income Taxes This note explains the absence of income tax provision due to losses, the application of a valuation allowance, and potential NOL utilization limitations - No provision for federal and state income taxes has been recorded due to incurred losses since inception for tax purposes[42] - A 100% valuation allowance has been applied against net deferred taxes, as the realization of deferred tax assets is not considered more likely than not[43] - The company has undergone three ownership changes through December 31, 2018, which could limit the utilization of net operating losses (NOLs), but management believes sufficient 'Built-In-Gain' offsets these limitations[45] Stock Incentive Plan This note details stock-based compensation expenses and provides information on outstanding stock options, restricted stock units, and unvested restricted shares Stock-Based Compensation Expense | | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $649,530 | $386,590 | $1,272,190 | $738,402 | | General and administrative expenses | $845,359 | $598,194 | $1,699,957 | $1,114,797 | | Total stock-based compensation expense | $1,494,889 | $984,784 | $2,972,147 | $1,853,199 | - 568,627 unvested restricted shares were issued to Helio founders, subject to vesting based on continuous service over three years[51] - As of June 30, 2019, 4,652,335 stock options were outstanding with a weighted average exercise price of $6.65, and 430,425 restricted stock units (RSUs) were outstanding[53][57] Stock Purchase Warrants This note reports on stock purchase warrants issued during the IPO that expired, with none outstanding as of the reporting date - Warrants to purchase 40,300 shares of common stock, issued in connection with the Initial Public Offering, expired on May 1, 2019[59] - As of June 30, 2019, none of these warrants were outstanding[59] Leases This note discusses the adoption of ASU Topic 842, Leases, and the recognition of Right-of-Use assets and corresponding operating lease liabilities - The company adopted ASU Topic 842, Leases, as of January 1, 2019[24][60] - As of June 30, 2019, the company recognized a Right-of-Use (ROU) asset and corresponding operating lease liability of $0.3 million[60] Lease Liabilities as of June 30, 2019 | Lease Liability Metric | Amount (June 30, 2019) | | :------------------------------- | :--------------------- | | Total Lease Payments | $352,221 | | Less effect of discounting | $(24,353) | | Present value of lease liabilities | $327,868 | | Current operating lease liabilities | $211,744 | | Operating lease liabilities, long-term | $116,124 | Legal Proceedings (Note 14) This note confirms the company is not aware of any pending legal proceedings expected to materially impact its financial position or operations - The company is not aware of any pending legal proceedings that would reasonably be expected to have a material impact on its financial position or results of operations[62] Commitments and Contingencies (Note 15) This note indicates no material changes to commitments and contingencies other than those related to the Helio acquisition and Credit Facility - There have been no material changes to the company's commitments and contingencies from the information provided in its Annual Report on Form 10-K for the fiscal year ended December 31, 2018, other than as set forth in Notes 3 (Helio acquisition) and 8 (Credit Facility)[62] Subsequent Events This note reports on subsequent events, including the announcement of Phase 3 RESET trial results and plans for regulatory discussions - In August 2019, the company announced results from Part 1 of the two-part adaptive Phase 3 RESET trial in Sjögren-Larsson Syndrome[63] - Aldeyra plans to discuss the RESET Part 1 results with regulatory authorities prior to initiating subsequent clinical testing[63] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting key developments, financial performance, liquidity, and future outlook, including risks and capital needs. It details the company's product pipeline, R&D strategy, and financial results for the reported periods Overview This section provides an overview of Aldeyra Therapeutics, its lead product candidate reproxalap, recent acquisitions, and funding activities - Aldeyra Therapeutics is a biotechnology company focused on developing and commercializing next-generation medicines for immune-mediated diseases[69] - Reproxalap, a RASP inhibitor, is the lead product candidate in late-stage development for dry eye disease (DED), allergic conjunctivitis (AC), and Sjögren-Larsson Syndrome (SLS)[69][70] - The company acquired Helio Vision, Inc. in January 2019, obtaining rights to ADX-2191, and in-licensed ADX-1612 and ADX-1615 to expand its pipeline[71] - No products are approved for sale, and revenue generation depends on regulatory approval or collaboration agreements[73] - From January 1, 2019, through June 30, 2019, the company sold 83,557 shares of common stock for $0.7 million net proceeds via the Jefferies Sales Agreement[74] - Entered into a $60 million Hercules Credit Facility in March 2019, but no capital has been drawn down as of June 30, 2019[76] Research and Development Expenses This section explains the company's policy for expensing research and development costs, including acquired in-process R&D, and future expectations - All research and development expenses are expensed as they are incurred, including non-clinical development, preclinical research, clinical trial, and regulatory-related costs[78] - Acquired in-process research and development payments are immediately expensed in the period incurred if the assets acquired are deemed to have no alternative future use[81] - The company expects a large percentage of future R&D expenses to support current and future non-clinical, preclinical, and clinical development programs[79] General and Administrative Expenses This section details the components of general and administrative expenses and anticipates future increases due to expanded operations and public company costs - General and administrative expenses primarily consist of payroll, benefits, stock-based compensation for full-time employees, and professional fees for auditing, tax, and legal services[83] - These expenses are expected to increase in the future as the company expands operating activities and incurs additional costs associated with being a publicly-traded company[83] Total Other Income (Expense) This section explains that total other income (expense) primarily comprises interest income and interest expense on outstanding debt - Total other income (expense) primarily consists of interest income earned on interest-bearing accounts, partially offset by interest expense incurred on outstanding debt[84] Comprehensive Loss (MD&A section) This section presents the comprehensive loss, including net loss and unrealized gains on marketable securities, for the reported periods Comprehensive Loss | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(28,951,193) | $(17,447,496) | | Unrealized gain on marketable securities | $23,000 | $15,000 | | Comprehensive loss | $(28,928,516) | $(17,432,224) | Critical Accounting Policies This section highlights critical accounting policies requiring management estimates, particularly for R&D costs, income taxes, and stock-based compensation - The preparation of financial statements requires management to make estimates and assumptions, particularly for accruals, research and development costs, acquired in-process research and development expense, income taxes, and stock-based compensation[22][86] - Assets purchased in an asset acquisition are expensed as in-process research and development unless they have an alternative future use[89] Results of Operations (MD&A section) This section analyzes the company's financial performance, comparing operating results for the three and six months ended June 30, 2019, and 2018 - Operating results are anticipated to fluctuate due to research and development efforts, clinical trial timing and outcomes, and regulatory requirements[90] - The company has incurred significant losses since inception, making predictions of future operations difficult[90] Three months ended June 30, 2019 compared to three months ended June 30, 2018 This subsection compares the company's financial performance for the three months ended June 30, 2019, against the same period in 2018 Three-Month Financial Performance Comparison | Metric | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | Change (YoY) | | :----------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Research and development expenses | $10.7 million | $6.8 million | +$3.9 million | | General and administrative expenses | $3.1 million | $2.4 million | +$0.7 million | | Total other income (expense), net | $0.4 million | $0.1 million | +$0.3 million | Six months ended June 30, 2019 compared to six months ended June 30, 2018 This subsection compares the company's financial performance for the six months ended June 30, 2019, against the same period in 2018 Six-Month Financial Performance Comparison | Metric | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | Change (YoY) | | :----------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Research and development expenses | $18.5 million | $13.4 million | +$5.1 million | | General and administrative expenses | $6.1 million | $4.3 million | +$1.8 million | | Acquired in-process R&D expenses | $6.5 million | $0 | +$6.5 million | | Total other income (expense), net | $0.9 million | $0.2 million | +$0.7 million | Liquidity and Capital Resources This section discusses the company's financial liquidity, capital resources, future funding requirements, and a summary of cash flow activities - As of June 30, 2019, the company had total stockholders' equity of approximately $67.3 million and cash, cash equivalents, and marketable securities of $69.5 million[98] - Current capital is expected to fund anticipated operating expenses through the end of 2020, but substantial additional funding will be required for all planned R&D activities, commercialization, or additional development requirements requested by the FDA[102] - Future funding requirements depend on factors such as clinical trial progress, regulatory approvals, manufacturing costs, and intellectual property maintenance[102][103] Cash Flow Summary | Cash Flow Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(25,442,857) | $(14,200,284) | | Net cash provided by investing activities | $17,086,480 | $5,658,088 | | Net cash provided by financing activities | $398,469 | $13,124,533 | Off-Balance Sheet Arrangements This section confirms the absence of any off-balance sheet arrangements as of the reporting period - Through June 30, 2019, the company had not entered into any relationships with unconsolidated entities or financial collaborations that would be considered off-balance sheet arrangements[110] Contractual Obligations (MD&A section) This section addresses contractual obligations, noting no material changes and detailing the Hercules Credit Facility - No material changes to contractual obligations since December 31, 2018, other than payments made or received in the ordinary course of business[111] - The Hercules Credit Facility, entered in March 2019, provides for a term loan of up to $60.0 million, with no amount outstanding as of June 30, 2019[112] Item 3. Quantitative and Qualitative Disclosures about Market Risk The company's market risk exposure is primarily limited to its cash, cash equivalents, and the Hercules Credit Facility. Due to the short-term maturities of its investments, interest rate fluctuations are not expected to have a significant impact on their realized value. Inflation has not materially affected operations - The company's exposure to market risk is confined to its cash, cash equivalents, and the Hercules Credit Facility[113] - Due to the short-term maturities of cash, cash equivalents, and marketable securities, an increase in market rates is not expected to have a significant impact on the realized value of investments[113] - The Hercules Credit Facility accrues interest at a variable annual rate but has not been utilized as of the filing date[113] - Inflation has not had a material impact on the company's results of operations[114] Item 4. Controls and Procedures Management, including the Chief Financial Officer and Chief Executive Officer, evaluated the effectiveness of disclosure controls and procedures and concluded they were effective at a reasonable assurance level. No material changes in internal control over financial reporting occurred during the period - Management concluded that disclosure controls and procedures were effective at the reasonable assurance level as of the end of the reporting period[115] - There has been no material change in internal control over financial reporting during the period covered by this report[116] PART II – OTHER INFORMATION This section provides additional information beyond the financial statements, including legal proceedings, risk factors, equity sales, defaults, and exhibits Item 1. Legal Proceedings (Part II section) The company may be involved in various legal proceedings in the ordinary course of business but is not currently a party to any threatened or pending material litigation that would reasonably be expected to have a material impact on its financial position or results of operations - The company is not a party to any threatened or pending material litigation[117] - Contingent liabilities are accrued when it is probable that future expenditures will be made and such expenditures can be reasonably estimated[117] Item 1A. Risk Factors This section outlines numerous risks that could materially affect the company's business, financial condition, and future results, including those related to product development, commercialization, intellectual property, financial position, and common stock. These risks highlight the challenges inherent in the biotechnology industry and the company's specific operational and financial vulnerabilities Risks Related to our Business and the Development and Commercialization of our Product Candidates This section details risks associated with the company's business, including significant operating losses, product development, and commercialization challenges - The company has incurred significant operating losses since inception ($29.0 million for the six months ended June 30, 2019) and expects to incur significant losses for the foreseeable future[119] - The business is largely dependent on the success of its single lead product candidate, reproxalap, which requires substantial clinical development and regulatory approval[121] - Developing novel product candidates and using adaptive trial designs for diseases with little clinical experience creates uncertain regulatory pathways and a greater risk of clinical trial failure or the need for additional trials[129][130] - The company relies completely on third parties to conduct clinical trials and supply drug substance/manufacture drug product, posing risks of delays, substandard performance, and supply disruptions[171][175] - The company has no internal sales, marketing, or distribution capabilities and will need to invest significant resources or enter into third-party agreements to commercialize products, if approved[186] Risks Relating to Our Intellectual Property This section outlines risks related to intellectual property, including obtaining and maintaining patent protection, potential infringement claims, and international enforcement - Commercial success depends on the ability to obtain and maintain patent and trade secret protection for product candidates and proprietary technologies[235] - Patent applications may not result in issued patents, and issued patents may be challenged, invalidated, modified, revoked, or circumvented by third parties[237] - Claims by third parties that the company infringes their proprietary rights could result in costly litigation, development delays, or the need to obtain royalty or licensing agreements[240] - Intellectual property rights in some foreign countries may be less extensive than in the United States, making enforcement difficult[250] Risks Related to Our Financial Position and Need for Capital This section addresses financial risks, including the need for substantial future capital, potential funding dilution, debt facility covenants, and NOL limitations - The company requires substantial future capital to complete clinical development and commercialization, as existing capital resources are insufficient[252][254] - Additional funding may not be available on acceptable terms, or at all, and could result in dilution to existing stockholders or require the company to relinquish rights to product candidates[255][256] - The secured debt facility with Hercules Capital imposes operating covenants and restrictions, and a default could lead to acceleration of repayment obligations or control of pledged assets[257] - The ability to use net operating loss carryforwards (NOLs) and tax credit carryforwards to offset future taxable income may be limited due to past and future ownership changes[258] Risks Related to Our Common Stock This section discusses risks related to the company's common stock, such as price volatility, fluctuating operating results, and the impact of being an emerging growth company - The trading price of the company's common stock has been and is likely to continue to be highly volatile, and an active trading market may not develop or be sustained[260] - Quarterly operating results may fluctuate significantly, and if they fall below expectations, the stock price could decline substantially[262][265] - As an emerging growth company, reduced reporting requirements may make the common stock less attractive to investors, potentially leading to a less active trading market and more volatile stock price[275] - Operating as a public company incurs significant increased costs and demands upon management, and failure to maintain proper and effective internal control over financial reporting could impair the ability to produce accurate and timely financial statements[277][279] - A small number of existing stockholders (approximately 32% by executive officers, directors, and greater than 5% stockholders) own a majority of the voting stock, limiting other stockholders' ability to influence corporate matters[269] - The company does not intend to pay dividends on its common stock, so the ability to achieve a return on investment will depend on appreciation in the stock price[272] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section confirms there were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds to report[285] Item 3. Defaults Upon Senior Securities This section confirms there were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[285] Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable[285] Item 5. Other Information This section indicates that there is no other information to report for the period - No other information to report[285] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and certifications from executive officers, along with XBRL formatted financial information - Exhibits include the Restated Certificate of Incorporation, Amended and Restated Bylaws, and certifications from the Principal Executive Officer and Principal Financial and Accounting Officer[286] - Financial information for the fiscal quarter ended June 30, 2019, is filed electronically in XBRL format[286] SIGNATURES This section provides the signatures of the Chief Executive Officer and Chief Financial Officer, certifying the report - The report was signed on August 9, 2019, by Todd C. Brady, M.D., Ph.D., Chief Executive Officer, and Joshua Reed, Chief Financial Officer[288]