aTyr Pharma, Inc.(ATYR) - 2019 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements This section presents the unaudited condensed consolidated financial statements, including detailed notes on accounting policies, collaboration agreements, debt, and equity activities Condensed Consolidated Balance Sheets Presents the company's financial position, including assets, liabilities, and equity, at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2019 | December 31, 2018 | | :-------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $14,507 | $22,962 | | Available-for-sale investments, short-term | $27,891 | $26,583 | | Total current assets | $43,871 | $50,803 | | Total assets | $48,762 | $52,746 | | Total current liabilities | $11,304 | $10,833 | | Total liabilities and stockholders' equity | $48,762 | $52,746 | | Total stockholders' equity | $30,226 | $33,650 | | Accumulated deficit | $(310,686) | $(298,701) | Condensed Consolidated Statements of Operations Details the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations (in thousands, except per share data) | 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 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $94 | $— | $94 | $— | | Research and development expenses | $3,314 | $6,484 | $6,659 | $12,634 | | General and administrative expenses | $2,421 | $3,476 | $4,953 | $7,546 | | Net loss | $(5,848) | $(10,412) | $(11,985) | $(21,079) | | Net loss per share, basic and diluted | $(1.80) | $(4.88) | $(4.23) | $(9.89) | | Weighted average common stock shares outstanding | 3,244,920 | 2,133,790 | 2,834,079 | 2,132,113 | Condensed Consolidated Statements of Comprehensive Loss Reports the net loss and other comprehensive income/loss components for the specified periods Condensed Consolidated Statements of Comprehensive Loss (in thousands) | 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 | $(5,848) | $(10,412) | $(11,985) | $(21,079) | | Change in unrealized gain on available-for-sale investments, net of tax | $51 | $8 | $28 | $35 | | Comprehensive loss | $(5,840) | $(10,361) | $(11,957) | $(21,044) | Condensed Consolidated Statements of Stockholders' Equity Outlines changes in the company's equity, including net loss, stock issuances, and stock-based compensation Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric | Balance as of Dec 31, 2018 | Balance as of Jun 30, 2019 | | :---------------------------------------------------------------- | :------------------------- | :------------------------- | | Total Stockholders' Equity | $33,650 | $30,226 | | Net loss (Q1 2019) | — | $(6,137) | | Net loss (Q2 2019) | — | $(5,848) | | Issuance of common stock from at the market offerings, net of offering costs | — | $1,381 (Q1) + $1,146 (Q2) | | Issuance of common stock from registered direct offering, net of offering costs | — | $4,918 | | Stock-based compensation | — | $571 (Q1) + $509 (Q2) | Condensed Consolidated Statements of Cash Flows Summarizes cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(10,844) | $(19,764) | | Net cash (used in) provided by investing activities | $(1,064) | $18,576 | | Net cash provided by (used in) financing activities | $3,453 | $(631) | | Net change in cash and cash equivalents | $(8,455) | $(1,819) | | Cash and cash equivalents at end of period | $14,507 | $19,272 | Notes to Condensed Consolidated Financial Statements Provides detailed explanations and disclosures supporting the condensed consolidated financial statements 1. Organization, Business, Basis of Presentation and Summary of Significant Accounting Policies This note outlines the company's core business in tRNA synthetase biology, significant financial events like the reverse stock split and accumulated deficit, and key accounting policy adoptions - aTyr Pharma, Inc. is focused on the discovery and development of innovative medicines based on novel immunological pathways, specifically the extracellular functionality of tRNA synthetases[24][80] - A 1-for-14 reverse stock split of issued and outstanding common stock became effective on June 28, 2019, with retrospective effect for all periods presented[27][288] - As of June 30, 2019, the company had an accumulated deficit of $310.7 million and expects to incur net losses for the foreseeable future. Existing cash, cash equivalents, and available-for-sale investments of $42.4 million are believed to be sufficient for one year from the filing date[28][109] - The company adopted ASU No. 2016-02, Leases (Topic 842), on January 1, 2019, recognizing a $3.5 million right-of-use asset and a corresponding lease liability on the balance sheet[31][38][63] - In March 2019, the company entered into a research collaboration and option agreement with CSL Behring, recognizing $94 thousand as collaboration revenue for the three months ended June 30, 2019[34][51][56] 2. Fair Value Measurements This note outlines the company's fair value measurement hierarchy for financial assets, primarily investment securities, which are mostly classified as Level 2 due to the use of observable inputs other than quoted prices - Fair value measurements are categorized into a three-tier hierarchy: Level 1 (quoted prices in active markets), Level 2 (observable inputs other than quoted prices), and Level 3 (unobservable inputs)[45][46] Assets Measured at Fair Value (in thousands) as of June 30, 2019 | Asset Category | Total | Level 1 | Level 2 | Level 3 | | :--------------------------------- | :---- | :------ | :------ | :------ | | Cash equivalents | $10,828 | $10,828 | $— | $— | | Available-for-sale investments, short-term: | | | | | | Asset-backed securities | $7,191 | $— | $7,191 | $— | | Commercial paper | $13,404 | $— | $13,404 | $— | | Corporate debt securities | $7,296 | $— | $7,296 | $— | | Total assets measured at fair value | $38,719 | $10,828 | $27,891 | $— | - As of June 30, 2019, all available-for-sale investments have effective maturity dates of less than one year and are in gross unrealized gain positions[49] 3. Research Collaboration This note details the research collaboration and option agreement with CSL Behring, where CSL funds R&D activities for product candidates derived from tRNA synthetases and offers potential milestone-based option fees - In March 2019, a research collaboration and option agreement was signed with CSL Behring for the development of product candidates from up to four tRNA synthetases, with CSL funding all related R&D activities[51][82] - CSL Behring will pay up to $4.25 million per synthetase program (totaling $17 million if all four advance) in option fees based on research milestones and their decision to continue development[52][82] - The company recognized $94 thousand as collaboration revenue for the three months ended June 30, 2019, using a cost-based input method, with research milestones being fully constrained until CSL proceeds to the next phase[55][56] 4. Debt, Commitments and Contingencies This note describes the company's term loan agreements, including outstanding principal and future payments, the impact of adopting new lease accounting standards on operating lease liabilities, and details related party transactions - The company has $20.0 million in term loans with Silicon Valley Bank and Solar Capital Ltd., with $11.3 million principal outstanding as of June 30, 2019, bearing interest at the prime rate plus 4.10%[57][58][60][139] Future Principal Payments for Term Loans (in thousands) | Year | Amount | | :--- | :----- | | 2019 | $4,000 | | 2020 | $7,333 | | Total | $11,333 | - As of June 30, 2019, the present value of operating lease payments is $3.3 million, with a weighted average remaining lease term of 3.9 years and a discount rate of 9.6%[63][65] - The research funding agreement with The Scripps Research Institute was terminated in November 2018. The Strategic Advisor Agreement with Dr. John D. Mendlein was terminated effective September 2019[66][67] 5. Stockholders' Equity This note details the company's equity financing activities, including at-the-market (ATM) offerings and a registered direct offering, as well as the conversion of preferred stock and stock-based compensation expenses - The ATM Offering Program with Cowen and Company, LLC was terminated in May 2019, having sold 193,670 shares for net proceeds of $1.4 million during the six months ended June 30, 2019[68][112] - A new ATM Offering Program with H.C. Wainwright & Co., LLC was established in May 2019 for up to $10.0 million, under which 252,872 shares were sold for net proceeds of $1.1 million during the three months ended June 30, 2019[69][113] - In April 2019, a registered direct offering sold 660,154 shares of common stock for gross proceeds of approximately $5.0 million[73][111] - In January 2019, 641,991 shares of Class X Convertible Preferred Stock were converted into 229,283 shares of common stock[72] Stock-based Compensation Expense (in thousands) | Category | 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 | $87 | $536 | $203 | $860 | | General and administrative | $422 | $675 | $877 | $1,279 | | Total | $509 | $1,211 | $1,080 | $2,139 | 6. Subsequent Events This note reports on equity sales conducted after the reporting period through the ATM Offering Program with Wainwright - In July 2019, the company sold an additional 358,815 shares of common stock through its ATM Offering Program with Wainwright, generating net proceeds of $1.9 million[77] 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 performance, liquidity, and capital resources, detailing the ongoing net losses, research and development focus, and financing activities, including the impact of recent accounting changes and future funding requirements Overview aTyr Pharma is a biotherapeutics company focused on novel immunological pathways, particularly tRNA synthetase biology, with its lead product candidate ATYR1923 in clinical trials for interstitial lung diseases. The company has consistently incurred net losses and relies on equity and debt financing - The company is a biotherapeutics company focused on the discovery and development of innovative medicines based on novel immunological pathways, specifically the extracellular functionality of tRNA synthetases and the Resokine pathway[80][81] - ATYR1923, a fusion protein and selective modulator of Neuropilin-2 (NRP2), is the clinical-stage product candidate, currently in a Phase 1b/2a proof-of-concept clinical trial for pulmonary sarcoidosis (an interstitial lung disease)[81] - A research collaboration and option agreement was entered with CSL Behring in March 2019 for the development of product candidates from up to four tRNA synthetases, with CSL funding R&D activities and potential option fees up to $17 million[82] - The company has incurred consolidated net losses of $12.0 million for the six months ended June 30, 2019, and $21.1 million for the six months ended June 30, 2018, with an accumulated deficit of $310.7 million as of June 30, 2019[87][146] Financial Operations Overview This section details the company's organizational structure, the impact of adopting new lease accounting standards, its revenue recognition policies for collaboration agreements, and the primary components of its research and development and general and administrative expenses - The condensed consolidated financial statements include the accounts of aTyr Pharma, Inc. and its 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma Limited[88] - The adoption of ASU No. 2016-02 (Leases) on January 1, 2019, resulted in the recognition of a right-of-use asset and a lease liability on the condensed consolidated balance sheets[89] - Revenue from collaboration agreements is recognized in accordance with ASC 606 and ASC 808, using a cost-based input method to measure proportional performance[93] - Research and development expenses primarily consist of salaries, preclinical and clinical development costs, manufacturing, CRO fees, and laboratory supplies, and are expected to increase with the advancement of the ATYR1923 program[94][96] - General and administrative expenses mainly include salaries, legal and patent services, insurance, occupancy costs, and information systems costs[98] Results of Operations The company reported a significant decrease in both research and development and general and administrative expenses for the three and six months ended June 30, 2019, compared to the prior year, primarily due to a workforce reduction and termination of a research collaboration Comparison of Results of Operations (in thousands) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Change | | :-------------------------------- | :------------------------------- | :------------------------------- | :----- | | 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 | | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | 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) | - The decrease in R&D expenses was primarily due to a $1.5 million (three months) / $2.6 million (six months) reduction in personnel costs from the May 2018 reduction in force, and a $0.5 million (three months) / $1.0 million (six months) decrease from the terminated research collaboration with The Scripps Research Institute[103][106] - The decrease in G&A expenses was mainly attributed to an $0.8 million (three months) / $1.9 million (six months) reduction in personnel costs and a decrease in professional fees[104][107] Liquidity and Capital Resources The company continues to incur losses and relies on existing cash and future capital raises through equity offerings, debt financings, or collaborations to fund its operations, particularly for advancing ATYR1923 and other R&D activities - As of June 30, 2019, the company had an accumulated deficit of $310.7 million and expects existing cash, cash equivalents, and available-for-sale investments of $42.4 million to be sufficient for one year[109] - Operations have been financed primarily through the sale of equity securities (ATM offerings, registered direct offering) and term loans[110][111][112][113][114] Summary of Net Cash Flow Activity (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(10,844) | $(19,764) | | Net cash (used in) provided by investing activities | $(1,064) | $18,576 | | Net cash provided by (used in) financing activities | $3,453 | $(631) | | Net decrease in cash | $(8,455) | $(1,819) | - Substantial additional funding will be required for ongoing activities, including clinical development of ATYR1923, other R&D, and potential commercialization efforts[119] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company assesses its exposure to market risks, including interest rate risk on investments and variable-rate debt, and foreign currency exchange risk from international operations, concluding that these risks do not currently have a material effect on its financial condition or results of operations - The company is exposed to interest rate risk on its $42.4 million in cash, cash equivalents, and available-for-sale investments, and its variable-rate Term Loans. A 100 basis point increase in interest rates would not materially affect results of operations[124][126] - Foreign currency exchange risk arises from expenses denominated in Pounds Sterling, Euro, Hong Kong dollar, and Australian dollar. While not hedged, fluctuations, including those related to Brexit, have not had a significant impact[127] - Inflation has not had a material effect on the company's results of operations or financial condition during the periods presented[128] Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures, concluding they were effective as of June 30, 2019, and reported no significant changes in internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2019[130] - No significant changes in internal control over financial reporting were identified during the three months ended June 30, 2019[131] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings and does not anticipate any existing claims to have a material adverse effect on its financial condition or operations - The company is not a party to any material legal proceedings at this time and does not believe any current claims would have a material adverse effect on its results of operations or financial condition[132] Item 1A. Risk Factors This section details various risks that could significantly impact the company's business, including those related to its financial condition, the discovery and development of product candidates, reliance on third parties, intellectual property, business operations, and the ownership of its common stock Risks related to our financial condition and need for additional capital The company faces significant financial risks due to its substantial accumulated deficit and ongoing losses, requiring continuous capital raises through equity or debt, which could lead to dilution or restrictive covenants, and may not be available on favorable terms - The company will need to raise substantial additional capital to fund its operations, including clinical trials, regulatory approvals, and commercialization efforts, and may need to seek funds sooner than planned[134][135] - Failure to obtain timely funding could force the company to curtail, delay, or discontinue research and development programs or commercialization efforts[136] - Future equity or debt financings could dilute stockholders, increase fixed payment obligations, and impose restrictive covenants on business activities[137][139] - The company has incurred significant losses since inception, with an accumulated deficit of $310.7 million as of June 30, 2019, and expects to continue incurring net losses for the foreseeable future[146][148] - The company has never generated revenue from product sales and does not anticipate doing so for the foreseeable future, making profitability dependent on successful product development and commercialization[150][152] Risks related to the discovery, development and regulation of our product candidates based on tRNA synthetase biology Developing novel tRNA synthetase-based therapeutics involves substantial risks, including potential delays or failures in clinical trials, difficulties in patient enrollment, the emergence of undesirable side effects, and complex manufacturing and regulatory challenges, all of which could impede commercialization - Clinical trials are expensive, time-consuming, and uncertain, with risks of delays, clinical holds, or failure to demonstrate safety and efficacy, which could delay or prevent regulatory approval[153][154] - The novel therapeutic approach of tRNA synthetase and NRP2 biology presents challenges in defining indications, obtaining regulatory approval from agencies with limited experience, and educating medical personnel[163][164] - Difficulties in identifying, recruiting, enrolling, and retaining sufficient patients, especially for rare diseases like pulmonary sarcoidosis, could delay or terminate clinical trials[160][161] - Product candidates may cause undesirable side effects (e.g., antibody development, infusion-related reactions), potentially leading to trial interruptions, more restrictive labeling, or denial of regulatory approval[172][173] - Manufacturing biologics is complex and highly regulated, with reliance on CDMOs posing risks of stoppages, delays, product loss due to contamination or equipment failure, and challenges in scaling production[178][181] - Regulatory approval is uncertain and may be subject to limitations on indications, conditions of approval, or costly post-marketing studies, and expedited designations (breakthrough, fast track) are not guaranteed[182][183][184] Risks related to our reliance on third parties The company's heavy reliance on third parties for manufacturing, clinical trials, and research introduces risks such as unsatisfactory performance, supply disruptions, and the potential for trade secret misappropriation or disclosure, which could significantly harm product development and commercialization - The company relies on third parties for product manufacturing, protocol development, research, and preclinical and clinical testing, reducing its direct control over these critical activities[193] - Reliance on contract development and manufacturing organizations (CDMOs) for ATYR1923 carries risks including inability to negotiate favorable terms, termination of agreements, and disruptions to operations, potentially delaying clinical development or commercialization[195][198] - Reliance on third-party CROs and clinical investigators means limited influence over their performance, and their failure to comply with GCPs or recruit sufficient patients could delay regulatory approval[199][201] - Sharing trade secrets with third-party manufacturers, collaborators, and consultants increases the risk of competitors discovering proprietary information or unauthorized use/disclosure, impairing the company's competitive position[203][204] Risks related to our intellectual property The company's competitive position is highly dependent on its ability to obtain, maintain, and protect intellectual property rights, which is challenging due to the complexity of patent law, potential for infringement claims, limitations of patent terms, and difficulties in enforcing rights globally - Obtaining and maintaining patent protection is uncertain due to complex legal and scientific questions, potential for invalidation, and the risk that patents may not adequately cover product candidates or prevent competitors[207][208] - Reliance on trade secret protection is vulnerable to disclosure, independent development, or inadequate legal recourse, which could impair the company's competitive position[209] - The company faces risks of costly litigation from third-party claims of patent infringement, potentially leading to substantial damages, royalties, or the inability to commercialize product candidates[213][214][216] - Patent terms may be inadequate to protect product candidates for a sufficient period due to long development and regulatory review timelines, potentially leading to early competition from generics or biosimilars[217] - The company may not be able to obtain necessary licenses for third-party intellectual property on reasonable terms, or disputes may arise with licensors, potentially hindering product development and commercialization[218][222][224] - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may offer less extensive protection, making it difficult to prevent infringement in certain countries[236][237] - Changes in patent law, including recent legislative and judicial developments, could diminish the value of patents, increase prosecution costs, and weaken the ability to obtain and enforce new patents[233][234] Risks related to our business operations Operational risks include the potential for misallocating resources, challenges in retaining key personnel, disruptions from internal restructuring, complexities of international operations, risks of employee misconduct, exposure to product liability claims, and vulnerabilities to system failures and cyber-attacks - Limited resources may lead to foregoing or delaying pursuit of potentially more profitable strategies or product candidates, impacting commercial potential[238] - The company's success is highly dependent on retaining key executive, scientific, and technical personnel, and competition for skilled individuals is intense[239] - Internal restructuring activities, such as the May 2018 workforce reduction, can cause disruptions, write-offs, and divert management attention, without guaranteed cost savings or efficiencies[240] - International operations (e.g., research in Hong Kong, clinical trials in Australia/Europe) expose the company to risks like differing regulatory requirements, reduced IP protection, economic instability, and foreign currency fluctuations[241] - The company is exposed to risks of fraud or misconduct by employees, principal investigators, consultants, and commercial partners, potentially leading to regulatory sanctions, reputational harm, or significant fines[243] - The use of product candidates in clinical trials and commercial sales exposes the company to product liability claims, which could result in substantial liability, costs, and negative impacts on regulatory approvals and reputation, with insurance coverage potentially being inadequate[244][245] - Information technology systems are vulnerable to cyber-attacks, natural disasters, and other failures, risking data loss, operational interruption, reputational harm, and delays in product development[251][252] - Compliance with federal and state healthcare fraud and abuse laws, as well as health information privacy and security laws (including GDPR), is critical, with non-compliance potentially leading to significant penalties and operational restructuring[253][254][255] - Operating as a public company incurs significant legal, accounting, and compliance costs, and management must devote substantial time to new initiatives, potentially diverting resources from core business activities[256] - Unfavorable global economic conditions (e.g., Brexit) or natural disasters (e.g., earthquakes in San Diego) could adversely affect business operations, financial condition, and ability to raise capital[258][259] Risks related to the commercialization of our product candidates Commercialization of product candidates is subject to significant risks, including the inability to establish effective sales and marketing capabilities, secure commercial manufacturing, intense competition from other pharmaceutical companies, and uncertainties regarding market acceptance, insurance coverage, and reimbursement policies - The company lacks internal sales, marketing, and distribution infrastructure and must either build these capabilities (expensive, time-consuming) or partner with third parties, which may result in lower revenues or less control[260][261] - Commercial manufacturing capabilities for product candidates have not been secured, and reliance on a limited number of third-party manufacturers poses risks of delays, technical issues, and supply disruptions[263][264][265] - The biotechnology and pharmaceutical industries are intensely competitive, with larger, better-resourced competitors potentially developing more effective, safer, or cheaper therapies, or achieving earlier market penetration[266][267] - Commercial success depends on market acceptance by physicians, patients, and third-party payors, which is uncertain for novel products and may require significant resources for education[268][269] - Insurance coverage and reimbursement status for newly approved products are uncertain, and failure to obtain adequate coverage and profitable payment rates could limit marketability and revenue, especially with increasing cost-containment pressures globally[270][271][272][273] Risks related to the ownership of our common stock Ownership of the company's common stock carries risks including high market price volatility, significant control exerted by executive officers and principal stockholders, potential dilution from future equity sales, reduced attractiveness due to 'emerging growth company' status, and the risk of Nasdaq delisting - The market price of the common stock is highly volatile and subject to wide fluctuations due to factors such as clinical trial results, regulatory decisions, competition, and general market conditions[274][275] - Executive officers, directors, and principal stockholders beneficially own approximately 45.5% of the voting stock, enabling them to exert significant control over matters requiring stockholder approval[276] - 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 increased stock price volatility[277][278] - Future sales and issuances of equity or debt securities, including through ATM offerings and registered direct offerings, could result in significant dilution to existing stockholders[280][281][282] - Lack of or negative research coverage by securities analysts could cause the stock price to decline[285] - The company faces the risk of Nasdaq delisting if it fails to maintain minimum financial and listing requirements, such as the $1.00 minimum bid price, which could adversely affect liquidity and stock price[287][289][290] - The ability to use net operating loss carryforwards (NOLs) and other tax attributes may be limited by ownership changes under Sections 382 and 383 of the Internal Revenue Code[292] - The company does not intend to pay no dividends on its common stock, limiting stockholder returns to stock appreciation[293] - Provisions in the company's amended and restated certificate of incorporation and bylaws, along with Delaware law, could make it more difficult for a third party to acquire the company or remove current management[294][295] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or use of proceeds for the period - None[297] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities for the period - None[298] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[299] Item 5. Other Information The company reported no other information for the period - None[300] Item 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including organizational documents, warrant agreements, sales agreements, and various certifications - The exhibits include the Restated Certificate of Incorporation, Certificate of Amendment, Amended and Restated Bylaws, various Warrant to Purchase Stock agreements, Common Stock Sales Agreements, and certifications required by Rules 13a-14(a) or 15d-14(a) and 18 U.S.C. Section 1350[302][303] SIGNATURES The report is officially signed by the company's President and Chief Executive Officer, Sanjay S. Shukla, M.D., M.S., and Chief Financial Officer, Jill M. Broadfoot, on August 14, 2019 - The report was signed on August 14, 2019, by Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, and Jill M. Broadfoot, Chief Financial Officer[307][308]