GlycoMimetics(GLYC) - 2020 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Presents unaudited financial statements and management's discussion for the first quarter of 2020 Item 1. Financial Statements This section presents the unaudited financial statements for GlycoMimetics, Inc. for the three months ended March 31, 2020 and 2019, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, financial instrument details, and specific transactions like licensing agreements and stock-based compensation Balance Sheets Presents key financial position metrics including cash, assets, liabilities, and equity for specified periods Balance Sheet Highlights (in thousands) | Metric | March 31, 2020 | December 31, 2019 | | :-------------------------- | :--------------- | :------------------ | | Cash and cash equivalents | $154,823 | $158,201 | | Total current assets | $156,882 | $162,528 | | Total assets | $162,099 | $167,970 | | Total current liabilities | $10,612 | $10,951 | | Total liabilities | $13,609 | $13,769 | | Total stockholders' equity | $148,490 | $154,201 | Unaudited Statements of Operations and Comprehensive Loss Details revenue, expenses, and net loss, providing a comprehensive view of operational performance Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenue | $9,000 | $— | | Research and development expense | $12,668 | $11,773 | | General and administrative expense | $4,440 | $3,360 | | Loss from operations | $(8,108) | $(15,133) | | Interest income | $445 | $1,049 | | Net loss and comprehensive loss | $(7,663) | $(14,084) | | Basic and diluted net loss per common share | $(0.18) | $(0.33) | Unaudited Statements of Stockholders' Equity Summarizes changes in common stock, paid-in capital, and accumulated deficit impacting stockholders' equity Changes in Stockholders' Equity (in thousands) | Metric | Balance at Dec 31, 2019 | Exercise of options | Stock-based compensation | Net loss | Balance at Mar 31, 2020 | | :-------------------------- | :---------------------- | :------------------ | :----------------------- | :------- | :---------------------- | | Common Stock (Amount) | $43,465 | $116 | $— | $— | $43,581 | | Additional Paid-In Capital | $412,599,772 | $129,856 | $1,822,148 | $— | $414,551,776 | | Accumulated Deficit | $(258,442,650) | $— | $— | $(7,662,604) | $(266,105,254) | | Total Stockholders' Equity | $154,200,587 | $129,972 | $1,822,148 | $(7,662,604) | $148,490,103 | Unaudited Statements of Cash Flows Summarizes cash flows from operating, investing, and financing activities, showing net change in cash and equivalents Statements of Cash Flows (in thousands) | Cash Flow Category | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,500) | $(14,348) | | Net cash used in investing activities | $(8) | $(40) | | Net cash provided by financing activities | $130 | $31 | | Net change in cash and cash equivalents | $(3,378) | $(14,357) | | Cash and cash equivalents, end of period | $154,823 | $195,561 | Notes to Unaudited Financial Statements Details significant accounting policies, financial instrument fair values, and specific transactions Note 1. Description of the Business Provides an overview of the company's biotechnology focus, financial history, and future funding strategy - GlycoMimetics, Inc. is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs for unmet medical needs in diseases where carbohydrate biology plays a key role[19] - The company has incurred significant operating losses since inception and expects to continue incurring losses and negative operating cash flows for the foreseeable future[20] - Management believes currently available funds will be sufficient to fund operations through at least 12 months from the filing date, intending to fund future operations through additional equity/debt offerings or strategic partnerships[20] Note 2. Significant Accounting Policies Outlines the basis of accounting, use of estimates, credit risk, revenue recognition, and expense policies Note 2.1 Basis of Accounting and Unaudited Financial Statements Explains the accrual method of accounting and the unaudited nature of interim financial statements - Financial statements are prepared based on the accrual method of accounting in accordance with U.S. GAAP[21] - The interim financial statements are unaudited, prepared in accordance with SEC rules for interim information, and include normal recurring adjustments[22] Note 2.2 Use of Estimates and Fair Value Measurements Discusses management's use of estimates and the fair value measurement of financial instruments - Management makes estimates and assumptions in financial statements, but does not believe differences from actual results would be material[23] - The company had no Level 2 or Level 3 assets or liabilities for fair value measurement as of March 31, 2020, and December 31, 2019[24] - Cash held in money market funds ($152.8 million as of March 31, 2020) approximates market values based on Level 1 inputs[24] Note 2.3 Concentration of Credit Risk Addresses credit risk concentration in cash and cash equivalents held with major financial institutions - Credit risk is primarily concentrated in cash and cash equivalents, consisting of money market funds with major U.S. financial institutions[25] - These funds are redeemable upon demand and bear minimal risk, with no anticipated losses[25] Note 2.4 Revenue Recognition Details the five-step model for revenue recognition, including license fees and milestone payments - The company applies ASC Topic 606, Revenue from Contracts with Customers, using a five-step model to recognize revenue[26] - Revenue from non-refundable, up-front license fees is recognized when the license is transferred and the licensee can use and benefit from it[29] - Milestone payments are included in the transaction price if probable of being reached without significant revenue reversal; regulatory approvals are not considered probable until received[30] Note 2.5 Research and Development Costs Explains the expensing of R&D costs and the estimation of clinical trial expenses - Research and development costs are expensed as incurred, primarily including employee-related expenses, CRO/investigative site costs, clinical trial materials, and CMO costs[33] - Clinical trial expenses are a significant component, with accruals based on estimates of patient enrollment, cycles, and site activations; historical estimates have not been materially different from actual costs[34][35] Note 2.6 Stock-Based Compensation Describes the accounting for stock-based payments using the Black-Scholes-Merton model - Stock-based payments are accounted for under ASC 718, with fair value estimated using the Black-Scholes-Merton model and recognized ratably over the vesting period[36] - Key assumptions for valuation include 0% expected dividend yield, expected volatility based on historical common stock volatility (since Jan 1, 2020), U.S. Treasury rate for risk-free interest, and an expected term of 6.25 years[38][39][40] Note 2.7 Net Loss Per Common Share Defines the calculation of basic net loss per common share and the exclusion of anti-dilutive securities - Basic net loss per common share is calculated by dividing net loss by the weighted-average common shares outstanding[41] - Potentially dilutive securities, including 6,291,212 stock options and restricted stock units, were excluded from diluted EPS computation for Q1 2020 as they were anti-dilutive[42] Note 2.8 Comprehensive Loss Confirms that net loss equals comprehensive net loss for the reported periods - For the three months ended March 31, 2020 and 2019, the company's net loss equaled comprehensive net loss, with no other changes in equity excluded from net loss[43] Note 2.9 Recently Issued Accounting Standards Discusses the adoption of new accounting standards and their impact on financial reporting - The company adopted ASU No. 2018-18, Collaborative Arrangements (Topic 808), as of January 1, 2020, which clarifies revenue recognition for transactions with collaborative arrangement participants[44] - The adoption of this standard had no effect on the company's operating results, cash flows, or financial position[44] Note 3. Prepaid Expenses and Other Current Assets Presents a breakdown of prepaid expenses and other current assets for specified periods Prepaid Expenses and Other Current Assets (in thousands) | Category | March 31, 2020 | December 31, 2019 | | :-------------------------------- | :--------------- | :---------------- | | Prepaid research and development expenses | $1,635 | $3,839 | | Other prepaid expenses | $332 | $302 | | Other receivables | $92 | $186 | | Total prepaid expenses and other current assets | $2,059 | $4,326 | Note 4. Property and Equipment Details the net value of property and equipment and associated depreciation expense Property and Equipment, Net (in thousands) | Category | March 31, 2020 | December 31, 2019 | | :-------------------------- | :--------------- | :---------------- | | Property and equipment, net | $763 | $823 | | Depreciation expense (Q1) | $68 | $70 | Note 5. Accrued Expenses Provides a breakdown of accrued expenses, including R&D, bonuses, and professional fees Accrued Expenses (in thousands) | Category | March 31, 2020 | December 31, 2019 | | :-------------------------------- | :--------------- | :---------------- | | Accrued research and development expenses | $4,243 | $5,150 | | Accrued bonuses | $1,171 | $2,677 | | Accrued consulting and other professional fees | $509 | $321 | | Accrued employee benefits | $549 | $352 | | Other accrued expenses | $178 | $211 | | Total accrued expenses | $6,651 | $8,711 | Note 6. Leases Describes the company's operating lease for office and research space and associated costs - The company leases office and research space in Rockville, Maryland, under an operating lease with a term through October 31, 2023[51] - As of March 31, 2020, the weighted-average remaining lease term was 3.6 years, and the incremental borrowing rate used was 8.0%[53][54] Operating Lease Costs (in thousands) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Operating lease cost | $232 | $232 | | Variable lease cost | $162 | $92 | | Total operating lease cost | $394 | $324 | Note 7. Stockholders' Equity Details changes in stockholders' equity, including stock option plans and compensation expense Note 7.1 At-The-Market Sales Facility Reports on the available at-the-market sales facility and recent sales activity - As of March 31, 2020, $80.0 million remained available to be sold under the September 2017 at-the-market sales agreement with Cowen and Company, LLC[55] - No shares were sold under this agreement during the three months ended March 31, 2020 or 2019[55] Note 7.2 2003 Stock Incentive Plan Summarizes outstanding options, exercise activity, and intrinsic value under the 2003 Stock Incentive Plan - As of March 31, 2020, 266,291 options were outstanding, vested, and exercisable under the 2003 Plan, with a weighted-average exercise price of $1.43 and a remaining contractual term of 1.2 years[57] - Total intrinsic value of options exercised was $459,098 in Q1 2020 and $129,250 in Q1 2019[57] - Total cash received for options exercised was $129,972 in Q1 2020 and $12,320 in Q1 2019[57] Note 7.3 2013 Equity Incentive Plan Details shares available, option activity, and unrecognized compensation expense under the 2013 Equity Incentive Plan - As of January 1, 2020, the number of shares available for issuance under the 2013 Plan automatically increased by 1,304,007 shares to 6,466,823 shares[59] 2013 Plan Stock Option Activity (as of March 31, 2020) | Metric | Outstanding Options | Weighted-Average Exercise Price | Weighted-Average Remaining Contractual Term (Years) | | :-------------------------- | :------------------ | :------------------------------ | :------------------------------------------ | | Outstanding | 5,708,241 | $9.08 | 7.3 | | Vested or expected to vest | 5,708,241 | $9.08 | 7.3 | | Exercisable | 3,032,134 | $9.44 | 5.7 | - The weighted-average fair value of options granted was $3.35 per share in Q1 2020 and $7.00 per share in Q1 2019[62] - As of March 31, 2020, there was $14.0 million of total unrecognized compensation expense related to unvested options (over ~1.9 years) and $1.0 million for RSUs (over ~1.5 years)[62][63] Note 7.4 Inducement Plan Introduces the Inducement Plan for new employees and reports on shares issued - The GlycoMimetics, Inc. Inducement Plan was adopted in January 2020, reserving 500,000 shares of common stock for new employees[65] - No shares of common stock were issued under the Inducement Plan during the three months ended March 31, 2020[65] Note 7.5 Stock-Based Compensation Expense Classification Categorizes stock-based compensation expense across research and development and general and administrative functions Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development expense | $736 | $508 | | General and administrative expense | $1,086 | $875 | | Total stock-based compensation expense | $1,822 | $1,382 | Note 8. Income Taxes Explains the absence of tax provision/benefit and the full valuation allowance on deferred tax assets - The company has not recorded any tax provision or benefit for the three months ended March 31, 2020 and 2019[67] - A valuation allowance has been provided for the full amount of net deferred tax assets, as realization of future benefits is not more-likely-than-not[67] Note 9. License and Collaboration Agreements Details the Apollomics collaboration agreement and the termination of the Pfizer rivipansel license - In January 2020, the company entered into a collaboration and license agreement with Apollomics (Hong Kong), Limited for GMI-1271 and GMI-1687 in China, Taiwan, Hong Kong, and Macau[68][69] - A $9.0 million non-refundable up-front payment was recognized as revenue in Q1 2020, allocated to the delivered functional licenses[70] - The agreement includes potential future payments of up to $75.0 million in development milestones, up to $105.0 million in sales-based commercial milestones, and tiered royalties ranging from high single digits to 15%[70] - Pfizer terminated its exclusive license agreement for rivipansel effective April 5, 2020, after the Phase 3 clinical trial did not meet its primary or key secondary efficacy endpoints[94] Note 10. Subsequent Events Addresses the potential impact of the COVID-19 pandemic on the company's business and financial performance - The COVID-19 pandemic, declared in March 2020, has created significant uncertainty regarding its impact on the company's business and financial performance[71] - The company is unable to determine the extent of the pandemic's impact on its operations and financial condition going forward, as developments are highly uncertain and unpredictable[72] 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 operational results, highlighting its clinical-stage biotechnology focus, drug pipeline development, financial performance for Q1 2020 vs. Q1 2019, liquidity, capital resources, and the potential impacts of the COVID-19 pandemic Overview Provides a strategic overview of the company's drug pipeline, financial outlook, and the impact of COVID-19 Overview - Company Overview and Drug Pipeline Introduces GlycoMimetics' focus on glycomimetic drugs and updates on lead candidates uproleselan and GMI-1359 - GlycoMimetics is a clinical-stage biotechnology company developing novel glycomimetic drugs for diseases like acute myeloid leukemia (AML), cancer, and inflammation[75][76] - Uproleselan, the lead drug candidate, is an E-selectin inhibitor in a randomized, double-blind, placebo-controlled Phase 3 clinical trial for relapsed/refractory AML and a Phase 2/3 trial with the NCI for previously untreated AML[77][78][81] - GMI-1359, targeting E-selectin and CXCR4, is in a Phase 1b trial for breast cancer patients with bone metastases and has orphan drug and rare pediatric disease designations for osteosarcoma[84] - The rivipansel program was terminated by Pfizer Inc. in February 2020 after its pivotal Phase 3 clinical trial for vaso-occlusive crisis in sickle cell disease did not meet primary or key secondary efficacy endpoints[86][94] Overview - Financial Outlook and Funding Needs Discusses the company's history of operating losses, anticipated expense increases, and future capital requirements - The company has incurred significant operating losses since inception, with an accumulated deficit of $266.1 million as of March 31, 2020, and expects continued losses[88] - Expenses are anticipated to increase substantially due to planned clinical trials for uproleselan, GMI-1359, and GMI-1687, NDA-enabling activities, manufacturing, and potential commercialization efforts[88][89] - Additional capital will be needed, potentially through equity/debt financings or collaborations, although the ability to raise capital on acceptable terms is uncertain, especially given the COVID-19 pandemic[90] Overview - COVID-19 Business Update Outlines the company's response to COVID-19, including operational adjustments and potential impacts on clinical trials and finances - The company has implemented business continuity plans, including remote work, in response to the COVID-19 pandemic[91] - Current financial impacts are limited, but delays in recruitment for the uproleselan Phase 3 clinical trial are being experienced[91] - The global economic slowdown and disruption of healthcare systems due to COVID-19 could materially adversely affect the company's business, financial condition, results of operations, and growth prospects[91] Our Collaboration and License Agreements Details the Apollomics collaboration and the termination of the Pfizer rivipansel agreement - In January 2020, the company entered an exclusive collaboration and license agreement with Apollomics for uproleselan and GMI-1687 in Greater China, receiving an upfront cash payment of $9.0 million[92] - Under the Apollomics agreement, the company is eligible to receive potential milestone payments totaling approximately $180.0 million and tiered royalties ranging from high single digits to 15% of net sales[92] - The Pfizer Agreement for rivipansel was terminated effective April 5, 2020, following the failure of its Phase 3 clinical trial, resulting in no further payments from Pfizer[94] Critical Accounting Policies and Significant Judgments and Estimates Highlights key accounting policies requiring subjective estimates and judgments in financial reporting - The preparation of financial statements requires subjective estimates and judgments, particularly for revenue recognition, accrued research and development expenses, stock-based compensation expense, and income taxes[96] - There have been no material changes to the company's critical accounting policies since December 31, 2019[97] Components of Operating Results Explains the primary drivers of revenue, research and development, and general and administrative expenses - Revenue to date has primarily consisted of upfront and milestone payments under license and collaboration agreements, with no revenue from drug sales[98] - Research and development expenses are expensed as incurred and are expected to increase significantly as drug candidates progress through clinical development[99][102] - General and administrative expenses, including personnel and professional fees, are also anticipated to increase to support continued R&D activities[104] Results of Operations for the Three Months Ended March 31, 2020 and 2019 Compares the company's financial performance for the first quarter of 2020 against 2019 Summary of Results of Operations (in thousands) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | Period-to-Period Change | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :---------------------- | | Revenue | $9,000 | $— | $9,000 | | Research and development expense | $12,668 | $11,773 | $895 | | General and administrative expense | $4,440 | $3,360 | $1,080 | | Loss from operations | $(8,108) | $(15,133) | $7,025 | | Interest income | $445 | $1,049 | $(604) | | Net loss and comprehensive loss | $(7,663) | $(14,084) | $6,421 | Results of Operations - Revenue Compares revenue recognized from collaboration agreements for the reported periods - Revenue of $9.0 million was recognized in Q1 2020 from the Apollomics Agreement, compared to no revenue in Q1 2019[107] Results of Operations - Research and Development Expense Analyzes changes in R&D expenses, driven by clinical trials and manufacturing costs - Research and development expense increased by $895,000 (8%) to $12.7 million in Q1 2020[109] - The increase was primarily due to a $2.4 million rise in clinical development costs for uproleselan trials and higher personnel-related and stock-based compensation expenses[109] - These increases were partially offset by a $2.1 million decrease in manufacturing and formulation costs[109] Results of Operations - General and Administrative Expense Examines the increase in G&A expenses due to personnel and professional fees - General and administrative expense increased by $1.1 million (32%) to $4.4 million in Q1 2020[110] - This increase was primarily driven by higher personnel-related costs (additional headcount and salary adjustments) and increased professional fees, including legal, patent, and consulting expenses[110] Results of Operations - Interest Income Explains the decrease in interest income due to lower cash balances and interest rates - Interest income decreased by $604,000 to $445,000 in Q1 2020 from $1.0 million in Q1 2019, due to lower average cash balances and reduced interest rates[111] Liquidity and Capital Resources Assesses the company's cash position, funding requirements, and future capital outlook Liquidity and Capital Resources - Sources of Liquidity Identifies primary sources of capital, including equity offerings and collaboration payments - The company's liquidity is primarily from public/private equity offerings and upfront/milestone payments from license and collaboration agreements[112] - As of March 31, 2020, cash and cash equivalents totaled $154.8 million[112] - An at-the-market sales agreement with Cowen has $80.0 million of common stock available for sale, with no sales in Q1 2020 or Q1 2019[113] Liquidity and Capital Resources - Funding Requirements Outlines the anticipated uses of capital and the uncertainties in future funding needs - Primary uses of capital include compensation, third-party clinical R&D services, laboratory supplies, clinical costs, legal/regulatory expenses, and general overhead[115] - The successful development of drug candidates is highly uncertain, making it difficult to estimate the nature, timing, and costs of future development[116] - Additional capital may be raised through equity or debt financings and collaboration arrangements, but availability on reasonable terms is not assured, and could lead to dilution or restrictions[117][118][119] Liquidity and Capital Resources - Outlook Provides an estimate for the sufficiency of existing cash and the impact of COVID-19 on the outlook - Existing cash and cash equivalents are expected to fund operating expenses and capital expenditure requirements into 2022[122] - This estimate is based on assumptions that may prove incorrect, and capital resources could be used sooner than expected[122] - The COVID-19 pandemic introduces uncertainty regarding changes in cash used in operating activities and the timing of clinical trial completion[122] Liquidity and Capital Resources - Cash Flows Summarizes cash flow activities and the significant decrease in cash used in operations Summary of Cash Flows (in thousands) | Cash Flow Category | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Operating activities | $(3,500) | $(14,348) | | Investing activities | $(8) | $(40) | | Financing activities | $130 | $31 | | Net change in cash and cash equivalents | $(3,378) | $(14,357) | - Net cash used in operating activities decreased significantly in Q1 2020, primarily due to the $9.0 million upfront payment from Apollomics, offsetting ongoing clinical development costs[124] Off-Balance Sheet Arrangements Confirms the absence of any off-balance sheet arrangements during the reporting period - The company did not have any off-balance sheet arrangements during the three months ended March 31, 2020[127] Item 3. Quantitative and Qualitative Disclosures about Market Risk This section assesses the company's exposure to market risks, primarily interest rate sensitivity on its cash and cash equivalents, concluding that an immediate 100 basis point change in interest rates would not materially affect the fair market value of its cash equivalents due to their short-term maturities and low-risk profile - The company's primary market risk exposure is interest rate sensitivity, affecting its cash and cash equivalents held in interest-bearing money market accounts[128] - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of cash equivalents due to their short-term maturities and low-risk profile[128] Item 4. Controls and Procedures This section confirms that management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2020, concluding they were effective at a reasonable assurance level. No material changes in internal controls over financial reporting occurred during the quarter - Management, with CEO and CFO participation, evaluated the effectiveness of disclosure controls and procedures as of March 31, 2020, concluding they were effective at the reasonable assurance level[131] - There have been no material changes in internal controls over financial reporting during the fiscal quarter ended March 31, 2020[132] PART II. OTHER INFORMATION High-level summary of legal, risk factors, and other disclosures Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings and is unaware of any pending or threatened legal actions that could materially adversely affect its business, operating results, cash flows, or financial condition - The company is not currently a party to any material legal proceedings and is unaware of any pending or threatened legal actions that could have a material adverse effect[133] Item 1A. Risk Factors This section updates the company's risk factors, emphasizing the adverse effects of health epidemics like COVID-19 on operations, clinical trials, and financial markets. It also reiterates the need for substantial additional funding, potential delays in clinical trial enrollment, and the inherent volatility of the company's common stock price Item 1A.1 Impact of Health Epidemics or Pandemics (COVID-19) Highlights the potential adverse effects of the COVID-19 pandemic on operations, clinical trials, and financial markets - The COVID-19 pandemic could materially affect operations, including headquarters and clinical trial sites, and disrupt third-party collaborators, manufacturers, and CROs[135][136] - Work-from-home policies and government orders may negatively impact productivity, disrupt business, and delay clinical programs and timelines[137] - Clinical trials may be affected by delays in site initiation and patient enrollment due to prioritization of hospital resources and patient movement restrictions[140] - The pandemic could significantly disrupt global financial markets, reducing access to capital and negatively affecting liquidity and common stock value[141] Item 1A.2 Need for Substantial Additional Funding Emphasizes the ongoing need for significant capital and the risks associated with fundraising efforts - The company will need substantial additional funding for continuing operations, as identifying and developing drug candidates is a time-consuming, expensive, and uncertain process[143][144] - Failure to raise capital when needed or on attractive terms could force delays, reductions, or termination of drug development programs or commercialization efforts[145] - The COVID-19 pandemic may adversely impact the ability to raise additional capital due to potential worsening global economic conditions and market disruptions[145] Item 1A.3 Delays in Clinical Trial Enrollment Discusses factors that could delay patient enrollment in clinical trials, including the COVID-19 pandemic - Delays or difficulties in patient enrollment for clinical trials, such as the uproleselan Phase 3 trial, could delay or prevent necessary regulatory approvals[146] - Factors affecting enrollment include the COVID-19 pandemic, orphan disease indications, competition, eligibility criteria, and patient referral practices[146] - Inability to enroll sufficient patients would result in significant delays, increased development costs, and could require abandoning trials, negatively impacting company value and financing ability[147] Item 1A.4 Volatility of Common Stock Price Addresses the inherent volatility of the company's stock price and potential impacts from market factors - The trading price of the company's common stock has been and is likely to remain volatile, influenced by various factors including drug development announcements, financial results, and industry trends[148][149] - Broad market and industry factors, such as worsening economic conditions and effects of the COVID-19 pandemic, may negatively affect the stock price regardless of operating performance[151] - Stock price volatility could lead to class action lawsuits, incurring substantial costs and diverting management's attention and resources[152] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or use of proceeds during the period - No unregistered sales of equity securities or use of proceeds occurred during the period[153] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including corporate documents, specimen stock certificates, the collaboration and license agreement with Apollomics, and certifications under the Sarbanes-Oxley Act - Key exhibits include the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Specimen stock certificate, Collaboration and License Agreement with Apollomics, and Certifications under Sections 302 and 906 of the Sarbanes-Oxley Act[154][155] Signatures The report is duly signed on behalf of GlycoMimetics, Inc. by Brian M. Hahn, Chief Financial Officer and Senior Vice President, as of May 1, 2020 - The report was signed by Brian M. Hahn, Chief Financial Officer and Senior Vice President, on behalf of GlycoMimetics, Inc. on May 1, 2020[160]