GlycoMimetics, Inc. (NASDAQ:GLYC) Q2 2020 Earnings Conference Call July 31, 2020 8:30 AM ET Company Participants Shari Annes - Investor Relations Rachel King - Chief Executive Officer Brian Hahn - Senior Vice President and Chief Financial Officer Helen Thackray - Senior Vice President, Development and Chief Medical Officer Conference Call Participants Zegbeh Jallah - ROTH Capital Partners Ed White - H.C. Wainwright Biren Amin - Jefferies Stephen Willey - Stifel Operator Good morning and thank you all for jo ...

GlycoMimetics, Inc. (NASDAQ:GLYC) Q1 2020 Earnings Conference Call May 1, 2020 8:30 AM ET Company Participants Shari Annes - Investor Relations Rachel King - Chief Executive Officer Brian Hahn - Senior Vice President and Chief Financial Officer Helen Thackray - Senior Vice President, Development and Chief Medical Officer Conference Call Participants Ed White - HC Wainwright Boris Peaker - Cowen Stephen Willey - Stifel Zegbeh Jallah - ROTH Capital Partners Biren Amin - Jefferies Operator Good morning and tha ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents unaudited financial statements and management's discussion for the first quarter of 2020 [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) 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](index=3&type=section&id=Balance%20Sheets) 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](index=4&type=section&id=Unaudited%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=5&type=section&id=Unaudited%20Statements%20of%20Stockholders'%20Equity) 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](index=6&type=section&id=Unaudited%20Statements%20of%20Cash%20Flows) 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](index=7&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) Details significant accounting policies, financial instrument fair values, and specific transactions [Note 1. Description of the Business](index=7&type=section&id=Note%201.%20Description%20of%20the%20Business) 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](index=19&type=chunk) - 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](index=20&type=chunk) - 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](index=20&type=chunk) [Note 2. Significant Accounting Policies](index=7&type=section&id=Note%202.%20Significant%20Accounting%20Policies) 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](index=7&type=section&id=Note%202.1%20Basis%20of%20Accounting%20and%20Unaudited%20Financial%20Statements) 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](index=21&type=chunk) - The interim financial statements are unaudited, prepared in accordance with SEC rules for interim information, and include normal recurring adjustments[22](index=22&type=chunk) [Note 2.2 Use of Estimates and Fair Value Measurements](index=9&type=section&id=Note%202.2%20Use%20of%20Estimates%20and%20Fair%20Value%20Measurements) 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](index=23&type=chunk) - 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](index=24&type=chunk) - Cash held in money market funds (**$152.8 million** as of March 31, 2020) approximates market values based on Level 1 inputs[24](index=24&type=chunk) [Note 2.3 Concentration of Credit Risk](index=9&type=section&id=Note%202.3%20Concentration%20of%20Credit%20Risk) 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](index=25&type=chunk) - These funds are redeemable upon demand and bear minimal risk, with no anticipated losses[25](index=25&type=chunk) [Note 2.4 Revenue Recognition](index=9&type=section&id=Note%202.4%20Revenue%20Recognition) 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](index=26&type=chunk) - 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](index=29&type=chunk) - 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](index=30&type=chunk) [Note 2.5 Research and Development Costs](index=11&type=section&id=Note%202.5%20Research%20and%20Development%20Costs) 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](index=33&type=chunk) - 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](index=34&type=chunk)[35](index=35&type=chunk) [Note 2.6 Stock-Based Compensation](index=13&type=section&id=Note%202.6%20Stock-Based%20Compensation) 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](index=36&type=chunk) - 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](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) [Note 2.7 Net Loss Per Common Share](index=13&type=section&id=Note%202.7%20Net%20Loss%20Per%20Common%20Share) 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](index=41&type=chunk) - 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](index=42&type=chunk) [Note 2.8 Comprehensive Loss](index=14&type=section&id=Note%202.8%20Comprehensive%20Loss) 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](index=43&type=chunk) [Note 2.9 Recently Issued Accounting Standards](index=14&type=section&id=Note%202.9%20Recently%20Issued%20Accounting%20Standards) 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](index=44&type=chunk) - The adoption of this standard had no effect on the company's operating results, cash flows, or financial position[44](index=44&type=chunk) [Note 3. Prepaid Expenses and Other Current Assets](index=14&type=section&id=Note%203.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) 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](index=15&type=section&id=Note%204.%20Property%20and%20Equipment) 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](index=15&type=section&id=Note%205.%20Accrued%20Expenses) 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](index=15&type=section&id=Note%206.%20Leases) 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](index=51&type=chunk) - 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](index=53&type=chunk)[54](index=54&type=chunk) 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](index=17&type=section&id=Note%207.%20Stockholders'%20Equity) Details changes in stockholders' equity, including stock option plans and compensation expense [Note 7.1 At-The-Market Sales Facility](index=17&type=section&id=Note%207.1%20At-The-Market%20Sales%20Facility) 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](index=55&type=chunk) - No shares were sold under this agreement during the three months ended March 31, 2020 or 2019[55](index=55&type=chunk) [Note 7.2 2003 Stock Incentive Plan](index=17&type=section&id=Note%207.2%202003%20Stock%20Incentive%20Plan) 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](index=57&type=chunk) - Total intrinsic value of options exercised was **$459,098** in Q1 2020 and **$129,250** in Q1 2019[57](index=57&type=chunk) - Total cash received for options exercised was **$129,972** in Q1 2020 and **$12,320** in Q1 2019[57](index=57&type=chunk) [Note 7.3 2013 Equity Incentive Plan](index=17&type=section&id=Note%207.3%202013%20Equity%20Incentive%20Plan) 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](index=59&type=chunk) 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](index=62&type=chunk) - 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](index=62&type=chunk)[63](index=63&type=chunk) [Note 7.4 Inducement Plan](index=19&type=section&id=Note%207.4%20Inducement%20Plan) 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](index=65&type=chunk) - No shares of common stock were issued under the Inducement Plan during the three months ended March 31, 2020[65](index=65&type=chunk) [Note 7.5 Stock-Based Compensation Expense Classification](index=19&type=section&id=Note%207.5%20Stock-Based%20Compensation%20Expense%20Classification) 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](index=19&type=section&id=Note%208.%20Income%20Taxes) 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](index=67&type=chunk) - 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](index=67&type=chunk) [Note 9. License and Collaboration Agreements](index=19&type=section&id=Note%209.%20License%20and%20Collaboration%20Agreements) 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](index=68&type=chunk)[69](index=69&type=chunk) - A **$9.0 million** non-refundable up-front payment was recognized as revenue in Q1 2020, allocated to the delivered functional licenses[70](index=70&type=chunk) - 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](index=70&type=chunk) - 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](index=94&type=chunk) [Note 10. Subsequent Events](index=21&type=section&id=Note%2010.%20Subsequent%20Events) 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](index=71&type=chunk) - 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](index=72&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=22&type=section&id=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](index=22&type=section&id=Overview%20-%20Company%20Overview%20and%20Drug%20Pipeline) 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](index=75&type=chunk)[76](index=76&type=chunk) - 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](index=77&type=chunk)[78](index=78&type=chunk)[81](index=81&type=chunk) - 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](index=84&type=chunk) - 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](index=86&type=chunk)[94](index=94&type=chunk) [Overview - Financial Outlook and Funding Needs](index=26&type=section&id=Overview%20-%20Financial%20Outlook%20and%20Funding%20Needs) 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](index=88&type=chunk) - 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](index=88&type=chunk)[89](index=89&type=chunk) - 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](index=90&type=chunk) [Overview - COVID-19 Business Update](index=28&type=section&id=Overview%20-%20COVID-19%20Business%20Update) 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](index=91&type=chunk) - Current financial impacts are limited, but delays in recruitment for the uproleselan Phase 3 clinical trial are being experienced[91](index=91&type=chunk) - 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](index=91&type=chunk) [Our Collaboration and License Agreements](index=28&type=section&id=Our%20Collaboration%20and%20License%20Agreements) 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](index=92&type=chunk) - 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](index=92&type=chunk) - 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](index=94&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) 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](index=96&type=chunk) - There have been no material changes to the company's critical accounting policies since December 31, 2019[97](index=97&type=chunk) [Components of Operating Results](index=30&type=section&id=Components%20of%20Operating%20Results) 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](index=98&type=chunk) - Research and development expenses are expensed as incurred and are expected to increase significantly as drug candidates progress through clinical development[99](index=99&type=chunk)[102](index=102&type=chunk) - General and administrative expenses, including personnel and professional fees, are also anticipated to increase to support continued R&D activities[104](index=104&type=chunk) [Results of Operations for the Three Months Ended March 31, 2020 and 2019](index=33&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20March%2031,%202020%20and%202019) 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](index=33&type=section&id=Results%20of%20Operations%20-%20Revenue) 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](index=107&type=chunk) [Results of Operations - Research and Development Expense](index=33&type=section&id=Results%20of%20Operations%20-%20Research%20and%20Development%20Expense) 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](index=109&type=chunk) - 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](index=109&type=chunk) - These increases were partially offset by a **$2.1 million** decrease in manufacturing and formulation costs[109](index=109&type=chunk) [Results of Operations - General and Administrative Expense](index=34&type=section&id=Results%20of%20Operations%20-%20General%20and%20Administrative%20Expense) 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](index=110&type=chunk) - 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](index=110&type=chunk) [Results of Operations - Interest Income](index=34&type=section&id=Results%20of%20Operations%20-%20Interest%20Income) 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](index=111&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, funding requirements, and future capital outlook [Liquidity and Capital Resources - Sources of Liquidity](index=34&type=section&id=Liquidity%20and%20Capital%20Resources%20-%20Sources%20of%20Liquidity) 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](index=112&type=chunk) - As of March 31, 2020, cash and cash equivalents totaled **$154.8 million**[112](index=112&type=chunk) - 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](index=113&type=chunk) [Liquidity and Capital Resources - Funding Requirements](index=35&type=section&id=Liquidity%20and%20Capital%20Resources%20-%20Funding%20Requirements) 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](index=115&type=chunk) - The successful development of drug candidates is highly uncertain, making it difficult to estimate the nature, timing, and costs of future development[116](index=116&type=chunk) - 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](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) [Liquidity and Capital Resources - Outlook](index=37&type=section&id=Liquidity%20and%20Capital%20Resources%20-%20Outlook) 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](index=122&type=chunk) - This estimate is based on assumptions that may prove incorrect, and capital resources could be used sooner than expected[122](index=122&type=chunk) - The COVID-19 pandemic introduces uncertainty regarding changes in cash used in operating activities and the timing of clinical trial completion[122](index=122&type=chunk) [Liquidity and Capital Resources - Cash Flows](index=37&type=section&id=Liquidity%20and%20Capital%20Resources%20-%20Cash%20Flows) 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](index=124&type=chunk) [Off-Balance Sheet Arrangements](index=39&type=section&id=Off-Balance%20Sheet%20Arrangements) 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](index=127&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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](index=128&type=chunk) - 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](index=128&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=131&type=chunk) - There have been no material changes in internal controls over financial reporting during the fiscal quarter ended March 31, 2020[132](index=132&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) High-level summary of legal, risk factors, and other disclosures [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=133&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) 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)](index=40&type=section&id=Item%201A.1%20Impact%20of%20Health%20Epidemics%20or%20Pandemics%20(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](index=135&type=chunk)[136](index=136&type=chunk) - Work-from-home policies and government orders may negatively impact productivity, disrupt business, and delay clinical programs and timelines[137](index=137&type=chunk) - Clinical trials may be affected by delays in site initiation and patient enrollment due to prioritization of hospital resources and patient movement restrictions[140](index=140&type=chunk) - The pandemic could significantly disrupt global financial markets, reducing access to capital and negatively affecting liquidity and common stock value[141](index=141&type=chunk) [Item 1A.2 Need for Substantial Additional Funding](index=41&type=section&id=Item%201A.2%20Need%20for%20Substantial%20Additional%20Funding) 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](index=143&type=chunk)[144](index=144&type=chunk) - Failure to raise capital when needed or on attractive terms could force delays, reductions, or termination of drug development programs or commercialization efforts[145](index=145&type=chunk) - The COVID-19 pandemic may adversely impact the ability to raise additional capital due to potential worsening global economic conditions and market disruptions[145](index=145&type=chunk) [Item 1A.3 Delays in Clinical Trial Enrollment](index=43&type=section&id=Item%201A.3%20Delays%20in%20Clinical%20Trial%20Enrollment) 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](index=146&type=chunk) - Factors affecting enrollment include the COVID-19 pandemic, orphan disease indications, competition, eligibility criteria, and patient referral practices[146](index=146&type=chunk) - 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](index=147&type=chunk) [Item 1A.4 Volatility of Common Stock Price](index=43&type=section&id=Item%201A.4%20Volatility%20of%20Common%20Stock%20Price) 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](index=148&type=chunk)[149](index=149&type=chunk) - 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](index=151&type=chunk) - Stock price volatility could lead to class action lawsuits, incurring substantial costs and diverting management's attention and resources[152](index=152&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=153&type=chunk) [Item 6. Exhibits](index=44&type=section&id=Item%206.%20Exhibits) 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](index=154&type=chunk)[155](index=155&type=chunk) [Signatures](index=46&type=section&id=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](index=160&type=chunk)

Part I [Business](index=5&type=section&id=ITEM%201.%20BUSINESS) GlycoMimetics is a clinical-stage biotechnology company developing glycomimetic drugs for rare diseases [Company Overview and Drug Candidates](index=5&type=section&id=Company%20Overview%20and%20Drug%20Candidates) The company develops novel glycomimetic drugs, with lead candidate Uproleselan targeting Acute Myeloid Leukemia (AML) - Uproleselan, a specific E-selectin inhibitor for treating Acute Myeloid Leukemia (AML), has been granted **Breakthrough Therapy designation** by the FDA and orphan drug designation in both the U.S. and Europe[17](index=17&type=chunk) - GMI-1359, a dual inhibitor of E-selectin and CXCR4, is in a **Phase 1b trial** for HR+ breast cancer patients with bone metastases[23](index=23&type=chunk) - Pfizer **terminated its license agreement for rivipansel** in February 2020 after the Phase 3 trial failed to meet its endpoints[28](index=28&type=chunk) [Strategy and Platform](index=9&type=section&id=Strategy%20and%20Platform) The company's strategy focuses on completing the Uproleselan Phase 3 trial and leveraging its glycomimetic platform - The company's primary strategic goal is to complete the clinical development of uproleselan for relapsed/refractory AML, with enrollment in the pivotal **Phase 3 trial** expected to be completed in the second half of 2021[31](index=31&type=chunk) - A collaboration with the National Cancer Institute (NCI) is underway to evaluate uproleselan in older adults with previously untreated AML[31](index=31&type=chunk) - The company entered into an exclusive license agreement with Apollomics in January 2020 to develop and commercialize uproleselan and GMI-1687 in Greater China[31](index=31&type=chunk) [Clinical Development Pipeline](index=13&type=section&id=Clinical%20Development%20Pipeline) The clinical pipeline is led by Uproleselan in Phase 3 for AML, with other candidates in earlier stages - The pivotal Phase 3 trial for uproleselan in relapsed/refractory AML is designed to enroll approximately **380 adult patients**, with overall survival as the primary endpoint[59](index=59&type=chunk)[60](index=60&type=chunk) - A Phase 1b trial for GMI-1359 in HR+ breast cancer patients with bone metastases was initiated in Q4 2019, with the first patient dosed in January 2020[68](index=68&type=chunk) Uproleselan Phase 1/2 Trial Key Results | Cohort | Key Metric | Result | | :--- | :--- | :--- | | Relapsed/Refractory AML | CR/CRi Rate | 41% | | Relapsed/Refractory AML | Median Overall Survival | 8.8 months | | Newly Diagnosed AML | CR/CRi Rate | 72% | | Newly Diagnosed AML | Median Overall Survival | 12.6 months | [Collaborations, IP, and Commercialization](index=21&type=section&id=Collaborations%2C%20IP%2C%20and%20Commercialization) The company manages its pipeline through strategic collaborations, protects its IP, and relies on third-party manufacturing - The collaboration with Apollomics for uproleselan and GMI-1687 in Greater China includes a **$9.0 million upfront payment**, up to **$180.0 million in potential milestones**, and tiered royalties[72](index=72&type=chunk) - The company has issued patents for uproleselan expected to expire between **2032 and 2033**, and for GMI-1359 expected to expire in **2036**[74](index=74&type=chunk) - The company does not have manufacturing facilities and **relies on third parties** for preclinical, clinical, and potential commercial manufacturing[82](index=82&type=chunk) [Competition and Government Regulation](index=25&type=section&id=Competition%20and%20Government%20Regulation) The company faces competition from established AML therapies and is subject to extensive government regulation - The company faces competition from several recently FDA-approved therapies for AML, including those from Novartis (RYDAPT®), Celgene (IDHIFA®), and Jazz Pharmaceuticals (VYXEOS)[91](index=91&type=chunk) - The drug development process is heavily regulated by the FDA, requiring preclinical studies, an effective IND, and adequate and well-controlled clinical trials[97](index=97&type=chunk)[98](index=98&type=chunk) - Uproleselan has received **Fast Track, Breakthrough Therapy, and Orphan Drug designations**, which may expedite review and provide market exclusivity[114](index=114&type=chunk)[119](index=119&type=chunk)[159](index=159&type=chunk) [Risk Factors](index=49&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant financial, clinical development, and operational risks, including a history of losses - The company has a history of significant operating losses, with an accumulated deficit of **$258.4 million** as of December 31, 2019[171](index=171&type=chunk) - The company will need substantial additional funding and believes its current cash will only fund operations into **2022**[178](index=178&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process, with potential delays in patient enrollment for its trials[193](index=193&type=chunk)[196](index=196&type=chunk) - The business **relies heavily on third parties** for manufacturing, conducting clinical trials, and commercialization in certain territories[201](index=201&type=chunk)[207](index=207&type=chunk)[211](index=211&type=chunk) [Unresolved Staff Comments](index=97&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) The company reports no unresolved staff comments from the SEC - None[320](index=320&type=chunk) [Properties](index=97&type=section&id=ITEM%202.%20PROPERTIES) The company leases approximately 42,000 square feet of office space in Rockville, Maryland - The company leases approximately **42,000 square feet** of office space in Rockville, Maryland, under a lease agreement that expires in October 2023[321](index=321&type=chunk) [Legal Proceedings](index=97&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[322](index=322&type=chunk) [Mine Safety Disclosures](index=97&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company's business - Not applicable[323](index=323&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=97&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on Nasdaq under "GLYC" and it does not anticipate paying dividends - Common stock is listed on The Nasdaq Global Market under the symbol **"GLYC"**[325](index=325&type=chunk) - The company has **never declared or paid dividends** and does not plan to in the foreseeable future[325](index=325&type=chunk) [Selected Financial Data](index=99&type=section&id=ITEM%206.%20SELECTED%20FINANCIAL%20DATA) This section summarizes key financial data from 2015 to 2019, showing consistent net losses and rising R&D expenses Selected Financial Data (2015-2019) | (in thousands) | 2019 | 2018 | 2017 | 2016 | 2015 | | :--- | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $ — | $ — | $ — | $ 18 | $ 20,071 | | **Research and development expense** | 47,029 | 40,092 | 24,100 | 23,282 | 25,050 | | **General and administrative expense** | 14,360 | 11,413 | 9,832 | 8,650 | 7,805 | | **Net loss** | $(57,892) | $(48,274) | $(33,281) | $(31,810) | $(12,769) | | **Cash and cash equivalents (End of Period)** | $158,201 | $209,918 | $123,925 | $40,042 | $46,803 | | **Total assets (End of Period)** | $167,970 | $214,839 | $128,583 | $42,388 | $48,462 | | **Total stockholders' equity (End of Period)** | $154,201 | $205,464 | $119,701 | $35,301 | $40,472 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=100&type=section&id=ITEM%207.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) The company's 2019 net loss increased to $57.9 million due to higher R&D and G&A expenses [Results of Operations (2019 vs. 2018)](index=113&type=section&id=Results%20of%20Operations%20(2019%20vs.%202018)) The net loss increased by $9.6 million in 2019, driven by higher clinical trial and personnel costs Results of Operations (in thousands) | | 2019 | 2018 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $ — | $ — | $ — | | **Research and development expense** | 47,029 | 40,092 | 6,937 | | **General and administrative expense** | 14,360 | 11,413 | 2,947 | | **Loss from operations** | (61,389) | (51,505) | (9,884) | | **Interest income** | 3,497 | 3,231 | 266 | | **Net loss** | $(57,892) | $(48,274) | $(9,618) | - Research and development expense increased by **$6.9 million (17%)** in 2019, primarily due to increased clinical costs for the ongoing global Phase 3 trial of uproleselan[383](index=383&type=chunk) - General and administrative expense increased by **$2.9 million (26%)** in 2019, mainly due to higher personnel-related costs and legal expenses[384](index=384&type=chunk) [Liquidity and Capital Resources](index=114&type=section&id=Liquidity%20and%20Capital%20Resources) The company had $158.2 million in cash as of year-end 2019, sufficient to fund operations into 2022 - As of December 31, 2019, the company had **$158.2 million** in cash and cash equivalents[386](index=386&type=chunk) - The company expects its existing cash and cash equivalents to fund operating expenses and capital expenditure requirements into **2022**[400](index=400&type=chunk) Summary of Cash Flows (in thousands) | | 2019 | 2018 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(51,984) | $(43,331) | | **Net cash used in investing activities** | (145) | (126) | | **Net cash provided by financing activities** | 413 | 129,450 | [Quantitative and Qualitative Disclosures About Market Risk](index=119&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company's primary market risk is interest rate sensitivity on its cash equivalents, which is considered immaterial - The company's primary market risk is interest rate sensitivity on its **$158.2 million** of cash and cash equivalents as of December 31, 2019[410](index=410&type=chunk) - Due to the short-term maturities and low-risk profile of its investments, the company does not believe interest rate changes would have a material effect on its financial position[410](index=410&type=chunk) [Financial Statements and Supplementary Data](index=119&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section references the location of the company's financial statements within the Form 10-K - The financial statements required for this item are listed in Part IV, Item 15 of the report[411](index=411&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=119&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) The company reports no changes in or disagreements with its accountants - None[412](index=412&type=chunk) [Controls and Procedures](index=119&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and internal controls were effective as of year-end 2019 - As of December 31, 2019, the company's CEO and CFO concluded that disclosure controls and procedures were **effective** at a reasonable assurance level[414](index=414&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2019, a conclusion audited and affirmed by Ernst & Young, LLP[415](index=415&type=chunk)[416](index=416&type=chunk) [Other Information](index=120&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) The company reports no other information for this item - None[418](index=418&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=120&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) Information is incorporated by reference from the company's 2020 proxy statement - Information is incorporated by reference from the 2020 Proxy Statement[421](index=421&type=chunk) [Executive Compensation](index=121&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Information is incorporated by reference from the company's 2020 proxy statement - Information is incorporated by reference from the 2020 Proxy Statement[422](index=422&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=121&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Information is incorporated by reference from the company's 2020 proxy statement - Information is incorporated by reference from the 2020 Proxy Statement[422](index=422&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=121&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) Information is incorporated by reference from the company's 2020 proxy statement - Information is incorporated by reference from the 2020 Proxy Statement[423](index=423&type=chunk) [Principal Accounting Fees and Services](index=121&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Information is incorporated by reference from the company's 2020 proxy statement - Information is incorporated by reference from the 2020 Proxy Statement[423](index=423&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=121&type=section&id=ITEM%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists the financial statements and exhibits filed as part of the Form 10-K - This item lists the financial statements and exhibits filed with the Form 10-K[425](index=425&type=chunk) [Form 10-K Summary](index=125&type=section&id=ITEM%2016.%20FORM%2010-K%20SUMMARY) This item is not applicable - Not applicable[430](index=430&type=chunk)

December 2019 | --- | --- | --- | --- | --- | |-----------------------|-------|-------|-------|-------| | | | | | | | CORPORATE | | | | | | OVERVIEW NASDAQ: GLYC | | | | | | | | | | | Innovation Today, Healing Tomorrow. Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts regarding GlycoMimetics, Inc. ("GlycoMimetics," "we," "us," or "our"), they are forward-looking statements reflecting management's current beliefs and expectations ...

Financial Data and Key Metrics Changes - As of September 30, 2019, GlycoMimetics' cash and cash equivalents were $170.9 million, down from $209.9 million as of December 31, 2018, indicating a decrease of $39 million [25] - Research and development expenses increased to $10.7 million for Q3 2019, compared to $9.7 million for Q3 2018, reflecting a rise of approximately 10.3% [25] - General and administrative expenses rose to $3.4 million for Q3 2019, up from $2.8 million in Q3 2018, marking an increase of about 21.4% [26] Business Line Data and Key Metrics Changes - The company is focusing on two key AML registration trials: one in the relapsed/refractory setting and another sponsored by the NCI for newly diagnosed patients [18] - Enrollment in both trials is ongoing, with strong enthusiasm from investigators [18] Market Data and Key Metrics Changes - The company is actively recruiting patients across multiple countries, including the U.S., Canada, Australia, and several European nations, for its clinical trials [52] Company Strategy and Development Direction - GlycoMimetics is prioritizing its resources on trials that could lead to registration, specifically the two AML studies [34] - The company is exploring the potential of uproleselan in newly diagnosed patients who are unfit for chemotherapy, with plans for a different study design [34] - The focus on E-selectin and its role in AML is central to the company's strategy, with ongoing research into its impact on drug resistance [17] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the upcoming ASH meeting, where new data supporting the role of E-selectin in AML will be presented [22] - The company is well-financed to continue its operations into 2022 and through key readouts, with a robust pipeline stemming from its specialized chemistry platform [23] Other Important Information - The Phase III study of rivipansel, partnered with Pfizer, failed to meet its primary and key secondary endpoints, leading to disappointment but an expectation for future data presentation [21] Q&A Session Summary Question: Impact of E-selectin group characteristics on survival rates - Management noted that while there are variations in clinical characteristics between high and low E-selectin groups, the overall risk profile remains high, and focusing on one component may not accurately reflect overall survival [32] Question: Discontinuation of collaboration with Haemato Oncology Foundation - Management emphasized the need to focus on trials that could drive registration and mentioned that the evolving standard of care influenced their decision [34] Question: Timeline for GMI-1359 program data - Data from the GMI-1359 program is expected at the end of 2020, with considerations for various cancer populations being explored [37] Question: Communication with NCI regarding trial data - Management confirmed that communication with NCI will be coordinated regarding the dissemination of interim data [44] Question: Cash runway and burn rate guidance - The cash burn rate is approximately $5 million per month for the remainder of 2019, increasing to about $6 million per month in 2020, allowing for cash availability into 2022 [57]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents GlycoMimetics, Inc.'s unaudited financial statements and management's analysis, detailing financial performance, liquidity, and market risks [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents GlycoMimetics, Inc.'s unaudited financial statements, reflecting continued operating losses and decreased equity due to R&D and lack of financing [Balance Sheets](index=3&type=section&id=Balance%20Sheets) **Balance Sheet Highlights (Unaudited):** | Metric | September 30, 2019 | December 31, 2018 | | :-------------------------------- | :------------------- | :------------------- | | Cash and cash equivalents | $170,886,792 | $209,917,595 | | Total current assets | $174,796,771 | $212,269,119 | | Total assets | $180,454,643 | $214,839,272 | | Total current liabilities | $10,436,339 | $8,763,154 | | Total liabilities | $13,373,666 | $9,374,777 | | Accumulated deficit | $(243,716,333) | $(200,550,739) | | Total stockholders' equity | $167,080,977 | $205,464,495 | - Cash and cash equivalents decreased by approximately **$39 million** from December 31, 2018, to September 30, 2019[8](index=8&type=chunk) - Total stockholders' equity decreased by approximately **$38.4 million**, primarily due to the accumulated deficit increasing by **$43.1 million**[8](index=8&type=chunk) [Unaudited Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) **Statements of Operations and Comprehensive Loss (Unaudited):** | Metric | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :-------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Revenue | $0 | $0 | $0 | $0 | | Research and development expense | $10,724,178 | $9,729,089 | $35,562,202 | $28,052,777 | | General and administrative expense | $3,380,932 | $2,790,431 | $10,491,991 | $8,492,194 | | Total costs and expenses | $14,105,110 | $12,519,520 | $46,054,193 | $36,544,971 | | Loss from operations | $(14,105,110) | $(12,519,520) | $(46,054,193) | $(36,544,971) | | Interest income | $853,228 | $944,409 | $2,888,599 | $2,178,253 | | Net loss and comprehensive loss | $(13,251,882) | $(11,575,111) | $(43,165,594) | $(34,366,718) | | Basic and diluted net loss per common share | $(0.31) | $(0.27) | $(1.00) | $(0.85) | - Net loss increased by **$1.68 million** (14.5%) for the three months ended September 30, 2019, and by **$8.80 million** (25.6%) for the nine months ended September 30, 2019, compared to the respective prior year periods[10](index=10&type=chunk) - Research and development expenses increased by **$995,089** (10.2%) for the three months and **$7,509,425** (26.8%) for the nine months ended September 30, 2019, year-over-year[10](index=10&type=chunk) [Unaudited Statements of Stockholders' Equity](index=5&type=section&id=Unaudited%20Statements%20of%20Stockholders'%20Equity) **Changes in Stockholders' Equity (Nine Months Ended September 30, 2019):** | Item | Common Stock Shares | Common Stock Amount | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | | :---------------------- | :-------------------- | :------------------ | :------------------------- | :------------------ | :------------------------- | | Balance at Dec 31, 2018 | 43,160,751 | $43,159 | $405,972,075 | $(200,550,739) | $205,464,495 | | Exercise of options | 199,198 | $199 | $292,892 | — | $293,091 | | Stock-based compensation | — | — | $4,488,985 | — | $4,488,985 | | Net loss | — | — | — | $(43,165,594) | $(43,165,594) | | Balance at Sep 30, 2019 | 43,359,949 | $43,358 | $410,753,952 | $(243,716,333) | $167,080,977 | - Total stockholders' equity decreased by **$38.38 million** during the nine months ended September 30, 2019, primarily due to the net loss[13](index=13&type=chunk) [Unaudited Statements of Cash Flows](index=6&type=section&id=Unaudited%20Statements%20of%20Cash%20Flows) **Statements of Cash Flows (Nine Months Ended September 30):** | Activity | 2019 | 2018 | | :-------------------------------- | :----------- | :------------ | | Net cash used in operating activities | $(39,191,323) | $(33,351,130) | | Net cash used in investing activities | $(132,571) | $(68,614) | | Net cash provided by financing activities | $293,091 | $129,323,640 | | Net change in cash and cash equivalents | $(39,030,803) | $95,903,896 | | Cash and cash equivalents, end of period | $170,886,792 | $219,828,634 | - Net cash used in operating activities increased by **$5.84 million** in 2019 compared to 2018[16](index=16&type=chunk) - Net cash provided by financing activities significantly decreased from **$129.3 million** in 2018 (due to a public offering) to **$0.29 million** in 2019[16](index=16&type=chunk) [Notes to Unaudited Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) - GlycoMimetics, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel glycomimetic drugs for diseases where carbohydrate biology plays a key role, such as inflammation, cancer, and infection. The company has not commercialized any drug candidates and expects to incur significant operating losses for the foreseeable future[19](index=19&type=chunk)[20](index=20&type=chunk) - The company adopted ASU 2016-02 Leases (Topic 842) effective January 1, 2019, recognizing right-of-use assets of approximately **$3.6 million** and related lease liabilities of **$4.3 million** for operating leases. The adoption did not materially affect net earnings or cash flows[46](index=46&type=chunk)[58](index=58&type=chunk) - Under the Pfizer Agreement for rivipansel, Pfizer announced on August 2, 2019, that the pivotal Phase 3 clinical trial did not meet its primary or key secondary efficacy endpoints. As a result, GlycoMimetics does not currently expect to receive any further milestone payments or royalties under this agreement[34](index=34&type=chunk)[74](index=74&type=chunk)[77](index=77&type=chunk) **Stock-Based Compensation Expense:** | Expense Category | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :-------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development expense | $610,506 | $429,477 | $1,697,171 | $1,282,040 | | General and administrative expense | $976,641 | $741,646 | $2,791,814 | $2,155,301 | | **Total stock-based compensation expense** | **$1,587,147** | **$1,171,123** | **$4,488,985** | **$3,437,341** | - As of September 30, 2019, there was **$13,050,347** of total unrecognized compensation expense related to unvested options under the 2013 Plan, to be recognized over a weighted-average period of approximately 2.7 years[70](index=70&type=chunk) - In September 2019, the company granted 332,106 Restricted Stock Units (RSUs) to non-executive employees, with **$1,477,649** of associated unrecognized compensation expense to be recognized over approximately two years[71](index=71&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=19&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's financial condition and operational results, focusing on clinical drug development, ongoing losses, increasing R&D, and future capital needs [Overview](index=19&type=section&id=Overview) - GlycoMimetics is a clinical-stage biotechnology company developing glycomimetic drugs for rare diseases, focusing on inflammation, cancer, and infection[84](index=84&type=chunk)[85](index=85&type=chunk) - Uproleselan, a lead drug candidate for Acute Myeloid Leukemia (AML), is in a randomized, double-blind, placebo-controlled Phase 3 clinical trial, with top-line results expected by the end of 2020. It has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk)[128](index=128&type=chunk) - GMI-1359, targeting E-selectin and CXCR4 for solid tumors metastasizing to bone, completed a Phase 1 trial, and a Phase 1b trial in breast cancer patients is anticipated in Q4 2019[90](index=90&type=chunk) - The Phase 3 clinical trial for rivipansel, licensed to Pfizer, did not meet its primary or key secondary efficacy endpoints, leading to no expected future milestone or royalty payments from Pfizer[92](index=92&type=chunk) - The company has incurred significant operating losses since inception, with an accumulated deficit of **$243.7 million** as of September 30, 2019, and expects continued losses[94](index=94&type=chunk) [Our Collaboration with Pfizer](index=22&type=section&id=Our%20Collaboration%20with%20Pfizer) - The 2011 license agreement with Pfizer for rivipansel granted Pfizer exclusive worldwide rights for development and commercialization[97](index=97&type=chunk) - GlycoMimetics received an upfront payment of **$22.5 million** and **$35.0 million** in milestone payments through September 30, 2019[98](index=98&type=chunk) - Following Pfizer's announcement on August 2, 2019, that the rivipansel Phase 3 trial failed, GlycoMimetics does not expect further milestone payments or royalties[97](index=97&type=chunk)[98](index=98&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=22&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - Financial statement preparation requires management estimates and judgments, particularly in revenue recognition, accrued R&D expenses, stock-based compensation, and income taxes[100](index=100&type=chunk) - No material changes to critical accounting policies have occurred since December 31, 2018[102](index=102&type=chunk) [Components of Operating Results](index=23&type=section&id=Components%20of%20Operating%20Results) - The company has not generated revenue from drug sales; revenue primarily stems from Pfizer agreement payments and nominal research grants[103](index=103&type=chunk)[104](index=104&type=chunk) - Research and development expenses are expensed as incurred and are expected to significantly increase as drug candidates progress through clinical development[105](index=105&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - General and administrative expenses are expected to increase to support continued research and development activities[112](index=112&type=chunk) [Results of Operations for the Three and Nine Months Ended September 30, 2019 and 2018](index=24&type=section&id=Results%20of%20Operations%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030%2C%202019%20and%202018) **Net Loss and Comprehensive Loss (in thousands):** | Period | 2019 | 2018 | Change | | :-------------------------------- | :--- | :--- | :----- | | Three Months Ended Sep 30 | $(13,252) | $(11,575) | $(1,677) | | Nine Months Ended Sep 30 | $(43,166) | $(34,367) | $(8,799) | **Research and Development Expense (in thousands):** | Period | 2019 | 2018 | Change | | :-------------------------------- | :--- | :--- | :----- | | Three Months Ended Sep 30 | $10,724 | $9,729 | $995 | | Nine Months Ended Sep 30 | $35,562 | $28,053 | $7,509 | - The increase in R&D expense was primarily due to higher clinical development expenses for the uproleselan Phase 3 trial and increased manufacturing costs for clinical supply, though manufacturing costs decreased in Q3 2019 year-over-year due to lower raw material purchases[116](index=116&type=chunk) **General and Administrative Expense (in thousands):** | Period | 2019 | 2018 | Change | | :-------------------------------- | :--- | :--- | :----- | | Three Months Ended Sep 30 | $3,381 | $2,790 | $591 | | Nine Months Ended Sep 30 | $10,492 | $8,492 | $2,000 | - G&A expense increased due to higher headcount, salary adjustments, stock option awards, and increased legal expenses[118](index=118&type=chunk) **Interest Income (in thousands):** | Period | 2019 | 2018 | Change | | :-------------------------------- | :--- | :--- | :----- | | Three Months Ended Sep 30 | $853 | $944 | $(91) | | Nine Months Ended Sep 30 | $2,888 | $2,178 | $710 | - Nine-month interest income increased due to higher cash balances from a March 2018 public offering, while three-month interest income decreased due to lower cash balances[120](index=120&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2019, cash and cash equivalents totaled **$170.9 million**[121](index=121&type=chunk) - Existing cash and cash equivalents are expected to fund operations through at least the end of 2020, covering preliminary results from the uproleselan Phase 3 clinical trial[128](index=128&type=chunk) - The company will need to raise additional capital through equity or debt financings or collaboration arrangements to fund future operations, as profitability is uncertain[96](index=96&type=chunk)[127](index=127&type=chunk) - The successful development of drug candidates is highly uncertain, making it difficult to estimate the nature, timing, and costs of future development or when material net cash inflows will commence[124](index=124&type=chunk) [Cash Flows](index=28&type=section&id=Cash%20Flows) **Summary of Cash Flows (Nine Months Ended September 30, in thousands):** | Activity | 2019 | 2018 | | :-------------------------------- | :--- | :--- | | Net cash used in operating activities | $(39,191) | $(33,351) | | Net cash used in investing activities | $(133) | $(69) | | Net cash provided by financing activities | $293 | $129,324 | | Net change in cash and cash equivalents | $(39,031) | $95,904 | - Net cash used in operating activities increased in 2019, primarily due to ongoing costs for uproleselan clinical development programs, including manufacturing and patient enrollment for the Phase 3 trial[130](index=130&type=chunk) - Net cash provided by financing activities significantly decreased in 2019 compared to 2018, as 2018 included **$128.4 million** from a public offering, while 2019 only saw proceeds from stock option exercises[132](index=132&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=29&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company's primary market risk is interest rate sensitivity on cash and cash equivalents, with no material impact expected from a 100 basis point rate change - The primary market risk is interest rate sensitivity, affecting cash and cash equivalents held in interest-bearing money market accounts[135](index=135&type=chunk) - An immediate 100 basis point change in interest rates would not materially affect the fair market value of cash equivalents due to their short-term maturities and low-risk profile[135](index=135&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=29&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were effective as of September 30, 2019, with no material changes in internal controls over financial reporting - Disclosure controls and procedures were evaluated as effective at a reasonable assurance level as of September 30, 2019[138](index=138&type=chunk) - No material changes in internal controls over financial reporting occurred during the fiscal quarter ended September 30, 2019[139](index=139&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other information including legal proceedings, risk factors, equity sales, exhibits, and official signatures [ITEM 1. LEGAL PROCEEDINGS](index=30&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently involved in any material legal proceedings, nor are any pending or threatened actions expected to have a material adverse effect - The company is not currently a party to any material legal proceedings[140](index=140&type=chunk) - No pending or threatened legal proceedings are expected to have a material adverse effect on the business[140](index=140&type=chunk) [ITEM 1A. RISK FACTORS](index=30&type=section&id=ITEM%201A.%20RISK%20FACTORS) Risk factors affecting the company's business remain materially unchanged from those disclosed in the prior Annual Report on Form 10-K - Risk factors have not materially changed from those described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018[141](index=141&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=30&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) No unregistered sales of equity securities or use of proceeds were reported for the period covered by this quarterly report - No unregistered sales of equity securities or use of proceeds to report[142](index=142&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, certifications, and XBRL files - Exhibits include Amended and Restated Certificate of Incorporation, Bylaws, Specimen stock certificate, Section 302 and 906 certifications, and XBRL documents[144](index=144&type=chunk) [Signatures](index=32&type=section&id=Signatures) The Form 10-Q report was officially signed by Brian M. Hahn, CFO and SVP of GlycoMimetics, Inc., on November 7, 2019 - The report was signed by Brian M. Hahn, Chief Financial Officer and Senior Vice President, on November 7, 2019[149](index=149&type=chunk)

GlycoMimetics, Inc. (NASDAQ:GLYC) Q2 2019 Earnings Conference Call August 1, 2019 8:30 AM ET Company Participants Shari Annes - IR Rachel King - President, CEO & Director Brian Hahn - SVP, CFO & Secretary Helen Thackray - SVP, Clinical Development & Chief Medical Officer Conference Call Participants Subhalaxmi Nambi - Cowen and Company Peter Lawson - SunTrust Robinson Humphrey Danielle Brill - Piper Jaffray Companies Stephen Willey - Stifel, Nicolaus & Company Biren Amin - Jefferies Edward White - H.C. Wain ...

PART I. FINANCIAL INFORMATION Provides GlycoMimetics, Inc.'s unaudited financial statements and management's discussion and analysis [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Presents GlycoMimetics, Inc.'s unaudited financial statements, including balance sheets, statements of operations, stockholders' equity, cash flows, and detailed notes [Balance Sheets](index=3&type=section&id=Balance%20Sheets%20as%20of%20June%2030%2C%202019%20%28unaudited%29%20and%20December%2031%2C%202018) Presents the company's financial position through comparative balance sheets Balance Sheet Highlights (June 30, 2019 vs. December 31, 2018) | Metric | June 30, 2019 (Unaudited) | December 31, 2018 | | :-------------------------------- | :------------------------ | :-------------------- | | **Assets** | | | | Cash and cash equivalents | $184,167,114 | $209,917,595 | | Total current assets | $186,468,724 | $212,269,119 | | Total assets | $192,334,843 | $214,839,272 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $10,632,887 | $8,763,154 | | Total liabilities | $13,775,900 | $9,374,777 | | Total stockholders' equity | $178,558,943 | $205,464,495 | | Accumulated deficit | $(230,464,451) | $(200,550,739) | - Total assets decreased from **$214.8 million** at December 31, 2018, to **$192.3 million** at June 30, 2019, primarily driven by a reduction in cash and cash equivalents[8](index=8&type=chunk) - Total liabilities increased from **$9.4 million** at December 31, 2018, to **$13.8 million** at June 30, 2019, largely due to the recognition of operating lease liabilities[8](index=8&type=chunk) [Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202019%20and%202018) Details the company's financial performance and comprehensive loss for the reported periods Statements of Operations and Comprehensive Loss Highlights | Metric (in thousands) | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | | :---------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenue | $— | $— | $— | $— | | Research and development expense | $13,065 | $9,302 | $24,838 | $18,324 | | General and administrative expense | $3,751 | $2,847 | $7,111 | $5,702 | | Total costs and expenses | $16,816 | $12,149 | $31,949 | $24,026 | | Loss from operations | $(16,816) | $(12,149) | $(31,949) | $(24,026) | | Interest income | $986 | $870 | $2,035 | $1,234 | | Net loss and comprehensive loss | $(15,830) | $(11,279) | $(29,914) | $(22,792) | | Basic and diluted net loss per common share | $(0.37) | $(0.26) | $(0.69) | $(0.58) | - Net loss increased significantly for both the three-month and six-month periods ended June 30, 2019, compared to 2018, primarily due to higher research and development expenses[10](index=10&type=chunk) - Research and development expenses increased by **$3.8 million** (**40%**) for the three months and **$6.5 million** (**36%**) for the six months ended June 30, 2019, driven by clinical trial activities for uproleselan[10](index=10&type=chunk) [Statements of Stockholders' Equity](index=5&type=section&id=Unaudited%20Statements%20of%20Stockholders%27%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202019%20and%202018) Outlines changes in stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit Stockholders' Equity Changes (Six-Month Period Ended June 30, 2019) | Item | Common Stock Shares | Common Stock Amount | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | | :---------------------- | :-------------------- | :------------------ | :------------------------- | :------------------ | :------------------------- | | Balance at Dec 31, 2018 | 43,160,751 | $43,159 | $405,972,075 | $(200,550,739) | $205,464,495 | | Exercise of options | 32,439 | $33 | $106,288 | — | $106,321 | | Stock-based compensation | — | — | $2,901,839 | — | $2,901,839 | | Net loss | — | — | — | $(29,913,712) | $(29,913,712) | | Balance at June 30, 2019 | 43,193,190 | $43,192 | $408,980,202 | $(230,464,451) | $178,558,943 | - Total stockholders' equity decreased from **$205.5 million** at December 31, 2018, to **$178.6 million** at June 30, 2019, primarily due to the net loss incurred during the period[13](index=13&type=chunk) - Additional paid-in capital increased by approximately **$3.0 million**, mainly from stock-based compensation and option exercises[13](index=13&type=chunk) [Statements of Cash Flows](index=6&type=section&id=Unaudited%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202019%20and%202018) Summarizes the company's cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (Six Months Ended June 30) | Activity (in thousands) | 2019 | 2018 | | :---------------------- | :----- | :----- | | Net cash used in operating activities | $(25,742) | $(23,267) | | Net cash used in investing activities | $(114) | $(42) | | Net cash provided by financing activities | $106 | $128,819 | | Net change in cash and cash equivalents | $(25,750) | $105,510 | | Cash and cash equivalents, end of period | $184,167 | $229,435 | - Net cash used in operating activities increased to **$25.7 million** in 2019 from **$23.3 million** in 2018, driven by higher clinical development and manufacturing costs[16](index=16&type=chunk)[132](index=132&type=chunk) - Financing activities provided significantly less cash in 2019 (**$0.1 million**) compared to 2018 (**$128.8 million**), as 2018 included proceeds from a public offering[16](index=16&type=chunk)[134](index=134&type=chunk) [Notes to Unaudited Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) Provides detailed explanations and disclosures supporting the unaudited financial statements [1. Description of the Business](index=7&type=section&id=1.%20Description%20of%20the%20Business) Describes the company's core business, drug development focus, and financial outlook - GlycoMimetics, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel glycomimetic drugs for diseases where carbohydrate biology is key, such as inflammation, cancer, and infection[19](index=19&type=chunk) - The company has not commercialized any drug candidates and has incurred significant operating losses since inception, relying on equity financings and expects continued losses[20](index=20&type=chunk) - Management believes current funds are sufficient for operations through at least 12 months from the report filing date and plans to fund future operations through additional equity/debt offerings or strategic partnerships[20](index=20&type=chunk) [2. Significant Accounting Policies](index=7&type=section&id=2.%20Significant%20Accounting%20Policies) Outlines the key accounting principles and policies applied in preparing the financial statements - The financial statements are unaudited and prepared in accordance with U.S. GAAP and SEC rules for interim financial information, reflecting normal recurring adjustments[22](index=22&type=chunk) - The company adopted ASU 2016-02 Leases (Topic 842) effective January 1, 2019, recognizing right-of-use assets and lease liabilities of approximately **$3.6 million** and **$4.3 million**, respectively, with no material impact on net earnings or cash flows[46](index=46&type=chunk) - Revenue recognition for licensing agreements follows ASC Topic 606, where non-refundable up-front fees are recognized when the license is transferred, and milestone payments are included in the transaction price if probable of not resulting in a significant revenue reversal[27](index=27&type=chunk)[28](index=28&type=chunk)[31](index=31&type=chunk) [3. Prepaid Expenses and Other Current Assets](index=15&type=section&id=3.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Details the composition and changes in prepaid expenses and other current assets Prepaid Expenses and Other Current Assets | Item | June 30, 2019 | December 31, 2018 | | :-------------------------------- | :------------ | :---------------- | | Prepaid research and development expenses | $1,594,492 | $1,608,768 | | Other prepaid expenses | $394,006 | $329,634 | | Other receivables | $313,112 | $413,122 | | Total | $2,301,610 | $2,351,524 | - Total prepaid expenses and other current assets slightly decreased from **$2.35 million** at December 31, 2018, to **$2.30 million** at June 30, 2019[50](index=50&type=chunk) [4. Property and Equipment](index=15&type=section&id=4.%20Property%20and%20Equipment) Summarizes the company's property and equipment, net of accumulated depreciation Property and Equipment, Net | Item | June 30, 2019 | December 31, 2018 | | :----------------------- | :------------ | :---------------- | | Property and equipment | $2,654,149 | $2,540,868 | | Less accumulated depreciation | $(1,724,251) | $(1,583,642) | | Property and equipment, net | $929,898 | $957,226 | | Depreciation expense (3 months) | $71,191 | $69,560 | | Depreciation expense (6 months) | $141,631 | $138,317 | - Net property and equipment decreased slightly from **$957,226** at December 31, 2018, to **$929,898** at June 30, 2019[51](index=51&type=chunk) [5. Accrued Expenses](index=15&type=section&id=5.%20Accrued%20Expenses) Presents the breakdown and changes in accrued expenses Accrued Expenses | Item | June 30, 2019 | December 31, 2018 | | :-------------------------------- | :------------ | :---------------- | | Accrued research and development expenses | $4,663,931 | $3,483,741 | | Accrued consulting and other professional fees | $431,754 | $140,397 | | Accrued employee benefits | $513,787 | $385,789 | | Other accrued expenses | $153,340 | $263,693 | | Total | $5,762,812 | $4,273,620 | - Total accrued expenses increased by approximately **$1.5 million**, or **34.8%**, from **$4.27 million** at December 31, 2018, to **$5.76 million** at June 30, 2019, primarily due to higher accrued research and development expenses[52](index=52&type=chunk) [6. Leases](index=15&type=section&id=6.%20Leases) Details the company's lease arrangements and related financial impacts - Upon adoption of ASU 2016-02 on January 1, 2019, the Company recorded a right-of-use asset of **$3.6 million** and a corresponding lease liability of **$4.3 million** for its operating lease of office and research space[58](index=58&type=chunk) - The weighted-average remaining lease term as of June 30, 2019, was **4.3 years**, with a discount rate of **8.01%** used for present value calculations[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) Operating Lease Costs and Liabilities | Item | 3 Months Ended June 30, 2019 | 6 Months Ended June 30, 2019 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Operating lease cost | $232,036 | $464,026 | | Variable lease cost | $84,723 | $176,481 | | Total operating lease cost | $316,759 | $640,507 | | Cash paid for operating leases | $255,493 | $508,880 | **Maturities of Lease Liability (as of June 30, 2019):** | Period | Operating Lease Obligation | | :-------------------------- | :------------------------- | | July 1, 2019 - Dec 31, 2019 | $518,028 | | 2020 | $1,052,581 | | 2021 | $1,078,895 | | 2022 | $1,105,867 | | 2023 | $846,830 | | Total | $4,602,201 | | Present value of lease payments | $3,904,324 | [7. Stockholders' Equity](index=18&type=section&id=7.%20Stockholders%27%20Equity) Provides information on stock option activity and changes in stockholders' equity - As of June 30, 2019, **$80.0 million** remained available to be sold under the September 2017 at-the-market sales agreement, with no shares sold during the six months ended June 30, 2019 or 2018[62](index=62&type=chunk) Stock Option Activity (2013 Plan, Six Months Ended June 30, 2019) | Item | Outstanding Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value (In thousands) | | :-------------------------- | :------------------ | :------------------------------ | :-------------------------------------------------- | :--------------------------------------- | | Outstanding as of Dec 31, 2018 | 3,265,254 | $8.39 | 7.1 | | | Options granted | 1,172,596 | $11.00 | | | | Options exercised | (16,606) | $5.66 | | | | Options forfeited | (4,175) | $16.24 | | | | Outstanding as of June 30, 2019 | 4,417,069 | $10.45 | 7.4 | $12,795 | | Exercisable as of June 30, 2019 | 2,450,440 | $9.00 | 6.1 | $9,830 | - Total unrecognized compensation expense related to unvested options under the 2013 Plan was **$14.6 million** as of June 30, 2019, to be recognized over approximately **2.8 years**[70](index=70&type=chunk) [8. Income Taxes](index=20&type=section&id=8.%20Income%20Taxes) Discusses the company's income tax position and deferred tax assets - The Company has not recorded any tax provision or benefit for the six months ended June 30, 2019 and 2018[73](index=73&type=chunk) - A full valuation allowance has been provided for net deferred tax assets, as realization of future benefits is not more-likely-than-not[73](index=73&type=chunk) [9. Research and License Agreements](index=21&type=section&id=9.%20Research%20and%20License%20Agreements) Outlines key research and license agreements, including milestone and royalty terms - The Pfizer Agreement grants Pfizer an exclusive worldwide license to rivipansel, with GlycoMimetics responsible for Phase 2 clinical trials and Pfizer for further development and commercialization[74](index=74&type=chunk) - GlycoMimetics received an up-front payment of **$22.5 million** and is eligible for potential milestone payments up to **$115.0 million** for development, **$70.0 million** for regulatory, and **$135.0 million** for sales milestones, plus tiered royalties[74](index=74&type=chunk)[97](index=97&type=chunk) - No revenue was recognized under the Pfizer Agreement during the six months ended June 30, 2019 or 2018, as all milestone amounts were fully constrained[76](index=76&type=chunk)[99](index=99&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=24&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Provides management's perspective on the company's financial condition and operational results for the three and six months ended June 30, 2019, compared to 2018 [Overview](index=24&type=section&id=Overview) Provides a high-level overview of the company's business, drug pipeline, and financial status - GlycoMimetics is a clinical-stage biotechnology company developing novel glycomimetic drugs for diseases involving carbohydrate biology, focusing on orphan diseases[82](index=82&type=chunk)[84](index=84&type=chunk) - Rivipansel, a pan-selectin antagonist for vaso-occlusive crisis in sickle cell disease, is in Phase 3 clinical trials by Pfizer, with top-line data expected in Q3 2019[84](index=84&type=chunk)[85](index=85&type=chunk) - Uproleselan, an E-selectin inhibitor for AML, is in a randomized Phase 3 clinical trial for relapsed/refractory AML (enrollment began Q4 2018, top-line results expected by end of 2020) and a Phase 2/3 trial for newly untreated AML in collaboration with NCI (enrollment began early 2019)[86](index=86&type=chunk)[87](index=87&type=chunk)[89](index=89&type=chunk) - The company is also developing GMI-1359, targeting E-selectin and CXCR4 for solid tumors, with a Phase 1b trial in breast cancer patients expected in H2 2019[91](index=91&type=chunk) - Since inception, the company has incurred significant operating losses, with an accumulated deficit of **$230.5 million** as of June 30, 2019, and expects continued losses[95](index=95&type=chunk) [Our Collaboration with Pfizer](index=29&type=section&id=Our%20Collaboration%20with%20Pfizer) Details the collaboration agreement with Pfizer for rivipansel, including milestone and royalty terms - The 2011 license agreement grants Pfizer exclusive worldwide rights to rivipansel, with GlycoMimetics eligible for up to **$320 million** in potential milestone payments and tiered royalties[97](index=97&type=chunk) - Milestone payments of **$15.0 million** (May 2014) and **$20.0 million** (June 2015) were received and recognized as revenue[99](index=99&type=chunk) - No milestone payments were received or recorded as revenue from Pfizer for the six months ended June 30, 2019 or 2018[99](index=99&type=chunk) - GlycoMimetics owes the University of Basel **10%** of all milestone and royalty payments received from Pfizer for rivipansel, with no payments due for the six months ended June 30, 2019 or 2018[100](index=100&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Highlights critical accounting policies and significant management judgments and estimates - Management's financial statements rely on estimates and judgments, particularly for revenue recognition, accrued R&D expenses, stock-based compensation, and income taxes[101](index=101&type=chunk) - No material changes to critical accounting policies have occurred since December 31, 2018[102](index=102&type=chunk) [Components of Operating Results](index=30&type=section&id=Components%20of%20Operating%20Results) Provides an overview of components of operating results [Revenue](index=30&type=section&id=Revenue) Discusses the company's revenue sources and recognition policies - The company has not generated revenue from drug sales and does not expect to in the near future; all revenue to date consists of up-front and milestone payments from Pfizer and nominal research grants[103](index=103&type=chunk)[104](index=104&type=chunk) [Research and Development](index=30&type=section&id=Research%20and%20Development) Explains the nature and trends of research and development expenses - R&D expenses are recognized as incurred and include compensation, facilities, supplies, clinical trials, manufacturing, and consulting fees[105](index=105&type=chunk)[108](index=108&type=chunk) - R&D expenses are expected to increase as uproleselan, GMI-1359, and other drug candidates progress through clinical development, including scaling up manufacturing for potential marketing approval[109](index=109&type=chunk) - The duration, costs, and timing of clinical trials are highly uncertain and depend on factors like patient enrollment, trial sites, regulatory requirements, and drug efficacy/safety[110](index=110&type=chunk) [General and Administrative](index=32&type=section&id=General%20and%20Administrative) Describes the components and trends of general and administrative expenses - G&A expenses primarily cover salaries, stock-based compensation, facility costs, legal fees (patent and corporate), and accounting/consulting services[111](index=111&type=chunk) - G&A expenses are anticipated to increase to support ongoing R&D activities[111](index=111&type=chunk) [Interest Income](index=32&type=section&id=Interest%20Income) Details the sources and trends of interest income - Interest income is derived from cash and cash equivalents[112](index=112&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202019%20and%202018) Analyzes the company's financial performance for the reported periods [Research and Development Expense](index=32&type=section&id=Research%20and%20Development%20Expense) Provides an overview of research and development expense R&D Expense by Functional Area (in thousands) | Functional Area | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | Change | | :------------------------------------ | :--------------------------- | :--------------------------- | :----- | | Clinical development | $2,512 | $1,438 | $1,074 | | Manufacturing and formulation | $6,033 | $4,451 | $1,582 | | Personnel-related | $2,595 | $1,886 | $709 | | Stock-based compensation | $579 | $427 | $152 | | Total R&D expense | $13,065 | $9,302 | $3,763 | | Functional Area | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | Change | | :------------------------------------ | :--------------------------- | :--------------------------- | :----- | | Clinical development | $5,119 | $2,296 | $2,823 | | Manufacturing and formulation | $11,276 | $9,340 | $1,936 | | Personnel-related | $4,914 | $3,745 | $1,169 | | Stock-based compensation | $1,087 | $853 | $234 | | Total R&D expense | $24,838 | $18,324 | $6,514 | - R&D expense increased by **$3.8 million** (**40%**) and **$6.5 million** (**36%**) for the three and six months ended June 30, 2019, respectively, primarily due to higher clinical development and manufacturing costs for uproleselan's Phase 3 trial[115](index=115&type=chunk) R&D Expense by Drug Candidate (in thousands) | Drug Candidate | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | Change | | :------------------------------------ | :--------------------------- | :--------------------------- | :----- | | Uproleselan | $8,870 | $6,099 | $2,771 | | GMI-1359 | $71 | $160 | $(89) | | Other R&D | $950 | $730 | $220 | | Personnel-related and stock-based compensation | $3,174 | $2,313 | $861 | | Total R&D expense | $13,065 | $9,302 | $3,763 | | Drug Candidate | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | Change | | :------------------------------------ | :--------------------------- | :--------------------------- | :----- | | Uproleselan | $16,744 | $12,123 | $4,621 | | GMI-1359 | $237 | $165 | $72 | | Other R&D | $1,857 | $1,438 | $419 | | Personnel-related and stock-based compensation | $6,000 | $4,598 | $1,402 | | Total R&D expense | $24,838 | $18,324 | $6,514 | [General and Administrative Expense](index=33&type=section&id=General%20and%20Administrative%20Expense) Provides an overview of general and administrative expense G&A Expense Components (in thousands) | Component | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | Change | | :------------------------------------ | :--------------------------- | :--------------------------- | :----- | | Personnel-related | $1,115 | $837 | $278 | | Stock-based compensation | $941 | $723 | $218 | | Legal, consulting and other professional expenses | $1,490 | $1,088 | $402 | | Total G&A expense | $3,751 | $2,847 | $904 | | Component | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | Change | | :------------------------------------ | :--------------------------- | :--------------------------- | :----- | | Personnel-related | $2,249 | $1,792 | $457 | | Stock-based compensation | $1,815 | $1,414 | $401 | | Legal, consulting and other professional expenses | $2,626 | $2,117 | $509 | | Total G&A expense | $7,111 | $5,702 | $1,409 | - G&A expense increased by **$904,000** (**32%**) and **$1.4 million** (**25%**) for the three and six months ended June 30, 2019, respectively, due to increased headcount, salary adjustments, stock option awards, and higher legal expenses[118](index=118&type=chunk) [Interest Income](index=34&type=section&id=Interest%20Income) Provides an overview of interest income - Interest income increased by **$116,000** (**13%**) and **$801,000** (**65%**) for the three and six months ended June 30, 2019, respectively, driven by higher average cash balances following a public offering in March 2018[119](index=119&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's financial liquidity and capital funding strategies [Sources of Liquidity](index=34&type=section&id=Sources%20of%20Liquidity) Identifies the primary sources of the company's liquidity - The company's operations are financed primarily through public offerings, private placements of capital stock, and up-front/milestone payments from Pfizer[120](index=120&type=chunk) - As of June 30, 2019, cash and cash equivalents totaled **$184.2 million**[120](index=120&type=chunk) - The company has an at-the-market sales agreement with Cowen for up to **$100.0 million** of common stock, with **$80.0 million** remaining available as of June 30, 2019, and no sales during the current reporting period[122](index=122&type=chunk) [Funding Requirements](index=34&type=section&id=Funding%20Requirements) Outlines the company's anticipated capital expenditure and funding needs - Primary capital uses include compensation, R&D services, laboratory supplies, clinical/manufacturing costs, legal/regulatory expenses, and general overhead[123](index=123&type=chunk) - Future funding needs are uncertain due to the unpredictable nature of drug development, including clinical trial success, regulatory approvals, and commercialization[124](index=124&type=chunk)[126](index=126&type=chunk) - Additional capital may be required through equity/debt financings or collaborations, which could dilute stockholders or impose restrictive covenants[127](index=127&type=chunk)[128](index=128&type=chunk) [Outlook](index=35&type=section&id=Outlook) Provides management's perspective on future financial and operational expectations - Existing cash and cash equivalents are expected to fund operations at least through the receipt of preliminary results from the Phase 3 clinical trial of uproleselan in relapsed/refractory AML, anticipated by the end of 2020[129](index=129&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) Analyzes cash flows from operating, investing, and financing activities [Operating Activities](index=36&type=section&id=Operating%20Activities) Details cash flows generated from or used in operating activities - Net cash used in operating activities for the six months ended June 30, 2019, was **$25.7 million**, primarily due to ongoing uproleselan clinical development programs, including significant manufacturing and clinical costs[131](index=131&type=chunk)[132](index=132&type=chunk) [Investing Activities](index=36&type=section&id=Investing%20Activities) Summarizes cash flows related to investing activities - Net cash used in investing activities for the six months ended June 30, 2019, was **$114,000**, primarily for computer and laboratory equipment[131](index=131&type=chunk)[133](index=133&type=chunk) [Financing Activities](index=36&type=section&id=Financing%20Activities) Explains cash flows from financing activities, including equity offerings - Net cash provided by financing activities for the six months ended June 30, 2019, was **$106,000**, solely from stock option exercises[131](index=131&type=chunk)[134](index=134&type=chunk) - In contrast, the prior year period (2018) saw **$128.8 million** from financing activities, including **$128.4 million** from a public offering[131](index=131&type=chunk)[134](index=134&type=chunk) [Off-Balance Sheet Arrangements](index=36&type=section&id=Off-Balance%20Sheet%20Arrangements) Reports on any off-balance sheet arrangements impacting the company - The company did not have any off-balance sheet arrangements during the six months ended June 30, 2019[135](index=135&type=chunk) [JOBS Act](index=36&type=section&id=JOBS%20Act) Discusses the company's election regarding the JOBS Act accounting transition period - The company has irrevocably elected not to use the extended transition period for complying with new or revised accounting standards provided by the JOBS Act, adopting new standards on the same dates as other public companies[136](index=136&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=36&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Discloses the company's exposure to market risks, primarily interest rate sensitivity - The company's primary market risk exposure is interest rate sensitivity, affecting its cash and cash equivalents[137](index=137&type=chunk) - As of June 30, 2019, cash and cash equivalents totaled **$184.2 million**, held in interest-bearing money market accounts[137](index=137&type=chunk) - Due to the short-term maturities and low-risk profile of investments, a **100 basis point** change in interest rates would not materially affect the fair market value of cash equivalents[137](index=137&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=37&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Details the evaluation of disclosure controls and procedures and changes in internal controls [(a) Evaluation of Disclosure Controls and Procedures](index=37&type=section&id=%28a%29%20Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Reports on the effectiveness of the company's disclosure controls and procedures - Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2019[140](index=140&type=chunk) - They concluded that disclosure controls and procedures were effective at a reasonable assurance level[140](index=140&type=chunk) [(b) Changes in Internal Controls Over Financial Reporting](index=37&type=section&id=%28b%29%20Changes%20in%20Internal%20Controls%20Over%20Financial%20Reporting) Reports on any material changes in internal controls over financial reporting - There have been no material changes in internal controls over financial reporting during the fiscal quarter ended June 30, 2019[141](index=141&type=chunk) PART II. OTHER INFORMATION Presents other required information not covered in the financial statements section [ITEM 1. LEGAL PROCEEDINGS](index=37&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Reports on any material legal proceedings involving the company - 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[142](index=142&type=chunk) [ITEM 1A. RISK FACTORS](index=37&type=page&id=ITEM%201A.%20RISK%20FACTORS) Refers to the company's risk factors that could adversely affect its financial condition and results of operations - Risk factors have not materially changed from those described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018[143](index=143&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=37&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Reports on any unregistered sales of equity securities and the use of proceeds - There were no unregistered sales of equity securities or use of proceeds to report[144](index=144&type=chunk) [ITEM 6. EXHIBITS](index=38&type=section&id=ITEM%206.%20EXHIBITS) Lists all exhibits filed with the Form 10-Q, including corporate documents and certifications - The exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, specimen stock certificate, Amended and Restated Non-Employee Director Compensation Policy, and Amended and Restated Executive Employment Agreements for key personnel[145](index=145&type=chunk) - Certifications of Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act are also included[145](index=145&type=chunk) [SIGNATURES](index=39&type=section&id=SIGNATURES) Contains the required signatures for the Form 10-Q filing - The report was signed by Brian M. Hahn, Chief Financial Officer and Senior Vice President, on August 1, 2019[150](index=150&type=chunk)

GlycoMimetics, Inc. (NASDAQ:GLYC) Q1 2019 Earnings Conference Call May 2, 2019 8:30 AM ET Company Participants Shari Annes - IR Rachel King - President, CEO & Director Brian Hahn - SVP, CFO & Secretary Helen Thackray - SVP, Clinical Development & Chief Medical Officer Conference Call Participants Edward White - H.C. Wainwright & Co. Irina Margine - Cowen and Company Biren Amin - Jefferies Operator Good morning, and thank you all for joining GlycoMimetics First Quarter 2019 Conference Call. [Operator Instruc ...