GlycoMimetics, Inc. (NASDAQ:GLYC) Q3 2021 Earnings Conference Call November 2, 2021 8:30 AM ET Company Participants Shari Annes - IR Harout Semerjian - CEO, President & Director Eric Feldman - SVP & Chief Medical Officer Brian Hahn - SVP & CFO Conference Call Participants Edward White - H.C. Wainwright & Co. Zegbeh Jallah - ROTH Capital Partners Jiale Song - Jefferies Operator Good morning, and thank you all for joining the GlycoMimetics call. [Operator Instructions]. I would now like to turn the call over ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents GlycoMimetics, Inc.'s unaudited interim financial statements, including balance sheets, operations, equity, and cash flows, with detailed notes [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section details GlycoMimetics, Inc.'s unaudited interim financial statements, including balance sheets, statements of operations, equity, and cash flows, with accompanying notes [Balance Sheets](index=4&type=section&id=Balance%20Sheets) This section presents the company's unaudited balance sheets, detailing assets, liabilities, and stockholders' equity as of September 30, 2021, and December 31, 2020 | Metric | September 30, 2021 (Unaudited) | December 31, 2020 | | :--------------------------------- | :----------------------------- | :------------------ | | Cash and cash equivalents | $101,924,284 | $137,035,017 | | Total current assets | $104,133,675 | $138,273,345 | | Total assets | $107,944,903 | $142,832,169 | | Total current liabilities | $9,660,412 | $12,428,369 | | Total liabilities | $11,379,155 | $14,612,713 | | Total stockholders' equity | $96,565,748 | $128,219,456 | [Unaudited Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's unaudited statements of operations and comprehensive loss for the three and nine months ended September 30, 2021 and 2020 | Metric (in $) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Revenue from collaboration and license agreements | 86,560 | 1,000,000 | 1,142,142 | 10,000,000 | | Research and development expense | 13,281,554 | 10,669,767 | 34,596,071 | 33,208,840 | | General and administrative expense | 4,141,952 | 4,057,530 | 12,567,404 | 12,732,207 | | Total costs and expenses | 17,423,506 | 14,727,297 | 47,163,475 | 45,941,047 | | Loss from operations | (17,336,946) | (13,727,297) | (46,021,333) | (35,941,047) | | Net loss and comprehensive loss | (17,332,321) | (13,722,535) | (46,005,641) | (35,464,168) | | Basic and diluted net loss per common share | (0.34) | (0.29) | (0.90) | (0.79) | [Unaudited Statements of Stockholders' Equity](index=6&type=section&id=Unaudited%20Statements%20of%20Stockholders%27%20Equity) This section presents the unaudited statements of stockholders' equity, detailing changes in equity for the nine months ended September 30, 2021 and 2020 - Total stockholders' equity decreased from **$128,219,456** at December 31, 2020, to **$96,565,748** at September 30, 2021, primarily due to net losses incurred during the period, partially offset by proceeds from common stock issuance and stock-based compensation[14](index=14&type=chunk) [Unaudited Statements of Cash Flows](index=7&type=section&id=Unaudited%20Statements%20of%20Cash%20Flows) This section provides the unaudited statements of cash flows, categorizing cash movements from operating, investing, and financing activities | Cash Flow Activity (in $) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :------------------------ | :----------------------------- | :----------------------------- | | Operating activities | (44,682,965) | (29,555,898) | | Investing activities | (12,496) | (30,332) | | Financing activities | 9,584,728 | 14,255,136 | | Net change in cash and cash equivalents | (35,110,733) | (15,331,094) | | Cash and cash equivalents, end of period | 101,924,284 | 142,870,347 | [Notes to Unaudited Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) This section provides detailed notes explaining the significant accounting policies and specific financial statement line items - Financial statements are prepared using the accrual method in accordance with U.S. GAAP and are unaudited interim statements[22](index=22&type=chunk)[23](index=23&type=chunk) - Revenue recognition follows ASC Topic 606, applying a five-step model for contracts with customers, particularly licensing agreements, with specific considerations for intellectual property, milestone payments, and royalties[29](index=29&type=chunk)[30](index=30&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - Stock-based compensation is valued using the Black-Scholes-Merton model and recognized ratably over the vesting period[40](index=40&type=chunk)[41](index=41&type=chunk) [1. Description of the Business](index=8&type=section&id=1.%20Description%20of%20the%20Business) GlycoMimetics, Inc. is a clinical-stage biotechnology company developing novel glycomimetic drugs, incurring significant losses and relying on external funding - GlycoMimetics, Inc.m is a clinical-stage biotechnology company developing novel glycomimetic drugs for diseases involving carbohydrate biology[19](index=19&type=chunk) - The company has not commercialized any drug candidates and has incurred significant operating losses since inception, expecting continued losses and negative operating cash flows[20](index=20&type=chunk) - Current funds are expected to be sufficient for operations through at least 12 months from the filing date, with future funding planned through equity/debt offerings or strategic partnerships[20](index=20&type=chunk) [2. Significant Accounting Policies](index=8&type=section&id=2.%20Significant%20Accounting%20Policies) This section details the company's significant accounting policies, covering GAAP basis, unaudited statements, estimates, fair value, revenue recognition, and stock-based compensation [Basis of Accounting](index=8&type=section&id=Basis%20of%20Accounting) This section clarifies that financial statements are prepared using the accrual method in accordance with U.S. GAAP - The financial statements are prepared based on the accrual method of accounting in accordance with U.S. GAAP[22](index=22&type=chunk) [Unaudited Financial Statements](index=8&type=section&id=Unaudited%20Financial%20Statements) This section states that interim financial statements are unaudited and prepared under SEC rules, not including all GAAP annual requirements - The accompanying financial statements are unaudited and prepared in accordance with SEC rules for interim financial information, not including all GAAP requirements for complete annual statements[23](index=23&type=chunk) [Use of Estimates](index=10&type=section&id=Use%20of%20Estimates) This section explains that financial statement preparation involves management estimates and assumptions, not believed to be material if actual results differ - Preparation of financial statements requires management to make estimates and assumptions, which, if different from actual results, are not believed to be material[26](index=26&type=chunk) [Fair Value Measurements](index=10&type=section&id=Fair%20Value%20Measurements) This section details fair value measurements, noting no Level 2 or 3 assets/liabilities and Level 1 inputs for cash in money market funds - The company had no Level 2 or Level 3 assets or liabilities as of September 30, 2021, and December 31, 2020. Cash held in money market funds (**$99.9 million** in 2021, **$135.0 million** in 2020) approximates market values (Level 1 inputs)[27](index=27&type=chunk) [Concentration of Credit Risk](index=10&type=section&id=Concentration%20of%20Credit%20Risk) This section addresses credit risk, primarily from cash and cash equivalents held in money market funds with major financial institutions - Credit risk is primarily from cash and cash equivalents held in money market funds with major financial institutions, which are redeemable on demand and bear minimal risk[28](index=28&type=chunk) [Revenue Recognition](index=10&type=section&id=Revenue%20Recognition) This section outlines the company's application of ASC Topic 606 for revenue recognition, including the five-step model for licensing and milestone payments - The company applies ASC Topic 606 for revenue recognition, using a five-step model to identify contracts, performance obligations, transaction price, allocation, and recognition[29](index=29&type=chunk) - Licensing of intellectual property revenue is recognized when the license is transferred, while milestone payments are included in the transaction price if probable of not resulting in significant revenue reversal[33](index=33&type=chunk)[34](index=34&type=chunk) - Sales-based royalties are recognized at the later of when sales occur or when the related performance obligation is satisfied; no royalty revenue has been recognized to date[35](index=35&type=chunk) [Accruals for Clinical Trial Expenses](index=12&type=section&id=Accruals%20for%20Clinical%20Trial%20Expenses) This section describes the accrual method for clinical trial expenses, which are outsourced and expensed as incurred based on various estimates - Clinical trial costs, a significant component of R&D, are primarily outsourced and expensed as incurred, with accruals based on estimates of patient enrollment, cycles, site activations, and project duration[37](index=37&type=chunk) [Stock-Based Compensation](index=14&type=section&id=Stock-Based%20Compensation) This section explains that stock-based payments are valued using the Black-Scholes-Merton model and recognized ratably over the vesting period - Stock-based payments are valued using the Black-Scholes-Merton model on the grant date and recognized ratably over the vesting period[40](index=40&type=chunk) [Net Loss Per Common Share](index=14&type=section&id=Net%20Loss%20Per%20Common%20Share) This section details the calculation of basic and diluted net loss per common share, noting the exclusion of anti-dilutive securities - Basic net loss per common share is calculated by dividing net loss by weighted-average common shares outstanding. Diluted net loss per share includes common stock equivalents, but **8,026,827** potentially dilutive securities were excluded in 2021 as anti-dilutive[45](index=45&type=chunk)[46](index=46&type=chunk) [Comprehensive Loss](index=15&type=section&id=Comprehensive%20Loss) This section states that net loss equaled comprehensive net loss for the reported periods, requiring no additional disclosure - For the three and nine months ended September 30, 2021 and 2020, net loss equaled comprehensive net loss, requiring no additional disclosure[47](index=47&type=chunk) [Recently Issued Accounting Standards](index=15&type=section&id=Recently%20Issued%20Accounting%20Standards) This section notes the adoption of ASU 2019-12 on January 1, 2021, which had no material impact on the financial statements - The company adopted ASU 2019-12 on January 1, 2021, which did not have a material impact on its financial statements[48](index=48&type=chunk) [3. Prepaid Expenses and Other Current Assets](index=15&type=section&id=3.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This section provides a breakdown of prepaid expenses and other current assets as of September 30, 2021, and December 31, 2020 | Category | September 30, 2021 | December 31, 2020 | | :-------------------------------- | :----------------- | :------------------ | | Prepaid research and development expenses | $1,749,697 | $965,504 | | Other prepaid expenses | $458,251 | $270,675 | | Other receivables | $1,443 | $2,149 | | **Total prepaid expenses and other current assets** | **$2,209,391** | **$1,238,328** | [4. Property and Equipment](index=15&type=section&id=4.%20Property%20and%20Equipment) This section details the net property and equipment, including accumulated depreciation, and reports depreciation expense for the periods | Category | September 30, 2021 | December 31, 2020 | | :----------------------- | :----------------- | :------------------ | | Property and equipment | $2,689,291 | $2,752,972 | | Less accumulated depreciation | $(2,261,253) | $(2,132,299) | | **Property and equipment, net** | **$428,038** | **$620,673** | - Depreciation expense was **$67,385** for Q3 2021 (vs. **$66,527** in Q3 2020) and **$202,957** for the nine months ended September 30, 2021 (vs. **$202,399** in 2020)[51](index=51&type=chunk) [5. Accrued Expenses](index=16&type=section&id=5.%20Accrued%20Expenses) This section presents a breakdown of accrued expenses, including R&D, bonuses, consulting fees, and employee benefits | Category | September 30, 2021 | December 31, 2020 | | :-------------------------------- | :----------------- | :------------------ | | Accrued research and development expenses | $4,558,927 | $5,114,420 | | Accrued bonuses | $1,695,665 | $3,341,184 | | Accrued consulting and other professional fees | $235,330 | $194,760 | | Accrued employee benefits | $641,705 | $569,048 | | Other accrued expenses | $163,538 | $220,469 | | **Total accrued expenses** | **$7,295,165** | **$9,439,881** | [6. Leases](index=16&type=section&id=6.%20Leases) This section describes the company's operating lease for office and research space, including lease costs and liability maturities - The company leases office and research space in Rockville, Maryland, under an operating lease expiring October 31, 2023. The weighted-average remaining lease term was **2.1 years** as of September 30, 2021[55](index=55&type=chunk)[59](index=59&type=chunk) | Lease Expense (in $) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Operating lease cost | 231,989 | 231,989 | 695,968 | 695,968 | | Variable lease cost | 146,421 | 144,009 | 344,450 | 449,964 | | **Total operating lease cost** | **378,410** | **375,998** | **1,040,418** | **1,145,932** | | Lease Liability Maturities (as of Sep 30, 2021) | | :-------------------------------- | :---------------- | | October 1, 2021 - December 31, 2021 | $272,871 | | 2022 | $1,104,356 | | 2023 | $940,840 | | **Present value of lease payments** | **$2,154,972** | [7. Stockholders' Equity](index=18&type=section&id=7.%20Stockholders%27%20Equity) This section details changes in stockholders' equity, including common stock issuances and various stock incentive plans - As of September 30, 2021, **51,738,894** shares of common stock were outstanding[4](index=4&type=chunk) [At-The-Market Sales Facility](index=18&type=section&id=At-The-Market%20Sales%20Facility) This section reports on common stock sales under the at-the-market facility, including net proceeds and remaining available amounts - Under the 2020 Sales Agreement with Cowen, the company sold **2,517,603** shares of common stock for net proceeds of **$9.6 million** during the nine months ended September 30, 2021[62](index=62&type=chunk) - As of September 30, 2021, approximately **$86.3 million** remained available to be sold under the 2020 Sales Agreement[62](index=62&type=chunk) [2003 Stock Incentive Plan](index=20&type=section&id=2003%20Stock%20Incentive%20Plan) This section provides details on outstanding and exercisable options under the 2003 Stock Incentive Plan - As of September 30, 2021, **93,465** options were outstanding, vested, and exercisable under the 2003 Plan, with a weighted-average exercise price of **$2.00**[65](index=65&type=chunk) [2013 Equity Incentive Plan](index=20&type=section&id=2013%20Equity%20Incentive%20Plan) This section outlines outstanding options and unvested RSUs under the 2013 Equity Incentive Plan, including unrecognized compensation expense - As of September 30, 2021, **5,822,162** options were outstanding under the 2013 Plan, with a weighted-average exercise price of **$8.22**[69](index=69&type=chunk) - Unrecognized compensation expense for unvested options under the 2013 Plan was **$6,702,323**, to be recognized over approximately **2.1 years**[69](index=69&type=chunk) - Unvested RSUs under the 2013 Plan totaled **397,600** shares as of September 30, 2021, with **$1,204,644** in unrecognized compensation expense over approximately **3.2 years**[71](index=71&type=chunk) [Inducement Plan](index=22&type=section&id=Inducement%20Plan) This section details options outstanding under the Inducement Plan, including reserved shares and unrecognized compensation expense - The Inducement Plan's reserved shares increased to **2,000,000** in August 2021. As of September 30, 2021, **1,713,600** options were outstanding, with a weighted-average exercise price of **$2.09**[73](index=73&type=chunk)[74](index=74&type=chunk) - Unrecognized compensation expense for unvested options under the Inducement Plan was **$1,654,155**, to be recognized over approximately **3.8 years**[74](index=74&type=chunk) - Performance-based options granted to the new CEO (**549,200** shares) have a maximum fair value of **$798,053**, excluded from unrecognized compensation expense as milestones are not yet probable[74](index=74&type=chunk) [8. Income Taxes](index=25&type=section&id=8.%20Income%20Taxes) This section states that no tax provision or benefit was recorded due to a full valuation allowance on net deferred tax assets - The company has not recorded any tax provision or benefit for the nine months ended September 30, 2021 and 2020, due to a full valuation allowance on net deferred tax assets[77](index=77&type=chunk) [9. License and Collaboration Agreements](index=25&type=section&id=9.%20License%20and%20Collaboration%20Agreements) This section describes the collaboration and license agreement with Apollomics for GMI-1271 and GMI-1687 in Greater China, including payments and potential milestones - In January 2020, the company entered a collaboration and license agreement with Apollomics for GMI-1271 and GMI-1687 in Greater China, receiving a **$9.0 million** upfront payment and a **$1.0 million** development milestone payment in September 2020[78](index=78&type=chunk)[81](index=81&type=chunk) - During the nine months ended September 30, 2021, the company recognized **$1.1 million** in revenue from the sale of clinical supplies to Apollomics[82](index=82&type=chunk) - The agreement includes potential future milestone payments up to **$75.0 million** for development and **$105.0 million** for sales-based commercial milestones, plus tiered royalties[78](index=78&type=chunk) [10. Risks and Uncertainties](index=27&type=section&id=10.%20Risks%20and%20Uncertainties) This section discusses the impact of the COVID-19 pandemic on clinical trials and the ongoing uncertainties regarding its effects on operations - The COVID-19 pandemic initially slowed clinical site initiation and patient recruitment for the Phase 3 uproleselan trial, though enrollment rates have returned to forecasted levels[84](index=84&type=chunk) - The full impact of the pandemic on operations and financial condition remains uncertain due to fluctuating infection rates and emerging variants[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of GlycoMimetics' financial condition and operational results, highlighting its clinical-stage focus, COVID-19 impact, and reliance on external financing - GlycoMimetics is a clinical-stage biotechnology company focused on developing novel glycomimetic drugs for diseases where carbohydrate biology plays a key role[87](index=87&type=chunk) - The lead drug candidate, uproleselan, is an E-selectin inhibitor in a Phase 3 clinical trial for relapsed/refractory AML, with enrollment expected to complete by year-end 2021[89](index=89&type=chunk) - The company has incurred significant operating losses since inception (**$355.5 million** accumulated deficit as of Sep 30, 2021) and expects this to continue, relying on equity financings and collaboration agreements[99](index=99&type=chunk) [Overview](index=28&type=section&id=Overview) This section provides an overview of GlycoMimetics as a clinical-stage biotechnology company, its drug candidates, and development focus - GlycoMimetics is a clinical-stage biotechnology company developing glycomimetic drugs, focusing on selectin antagonists for inflammation, cancer, and infection, particularly for orphan drug indications[87](index=87&type=chunk)[88](index=88&type=chunk) - Uproleselan, a specific E-selectin inhibitor, is in a randomized, double-blind, placebo-controlled Phase 3 clinical trial for relapsed/refractory AML, with enrollment expected to complete by year-end 2021[89](index=89&type=chunk) - Other pipeline candidates include GMI-1687 (subcutaneously administered E-selectin antagonist) and GMI-1359 (targets E-selectin and CXCR4), with preclinical programs targeting galectin-3[96](index=96&type=chunk)[97](index=97&type=chunk) [Impact of COVID-19 on Our Business](index=32&type=section&id=Impact%20of%20COVID-19%20on%20Our%20Business) This section discusses the initial slowdown in clinical trials due to COVID-19 and the company's ongoing monitoring of the pandemic's business impact - COVID-19 initially caused slowed clinical site initiation and patient recruitment for the uproleselan Phase 3 trial, though enrollment rates have since returned to forecasted levels[102](index=102&type=chunk) - The company has implemented business continuity plans, including remote work, and continues to monitor the pandemic's potential adverse effects on its business and financial condition[103](index=103&type=chunk) [Our Collaboration and License Agreements](index=34&type=section&id=Our%20Collaboration%20and%20License%20Agreements) This section details the collaboration with Apollomics for uproleselan and GMI-1687 in Greater China, including payments and regulatory milestones - In January 2020, GlycoMimetics partnered with Apollomics for uproleselan and GMI-1687 in Greater China, receiving a **$9.0 million** upfront payment and a **$1.0 million** development milestone payment in September 2020[104](index=104&type=chunk) - Apollomics received IND approval for uproleselan in China in September 2020 and Breakthrough Therapy Designation in January 2021, initiating a Phase 1 study in March 2021[105](index=105&type=chunk) - The company recognized **$1.1 million** in revenue from clinical supply sales to Apollomics during the nine months ended September 30, 2021[106](index=106&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section outlines critical accounting policies and significant judgments, noting no material changes since December 31, 2020 - Management's discussion is based on financial statements prepared under U.S. GAAP, requiring subjective estimates and judgments in areas like revenue recognition, R&D expenses, stock-based compensation, and income taxes[107](index=107&type=chunk) - There have been no material changes to critical accounting policies since December 31, 2020[108](index=108&type=chunk) [Components of Operating Results](index=35&type=section&id=Components%20of%20Operating%20Results) This section breaks down the components of operating results, including revenue, research and development, general and administrative, and interest income - The company has not generated revenue from drug sales and expects R&D expenses to increase as drug candidates progress through clinical development[109](index=109&type=chunk)[113](index=113&type=chunk) [Revenue](index=35&type=section&id=Revenue) This section clarifies that all revenue to date is from upfront and milestone payments under license agreements, with no drug sales - To date, all revenue has come from upfront and milestone payments under license and collaboration agreements, with no revenue from drug sales[109](index=109&type=chunk) [Research and Development](index=35&type=section&id=Research%20and%20Development) This section details R&D expenses, including compensation, facilities, clinical trial costs, and expected increases as candidates advance - R&D expenses include compensation, facilities, lab supplies, clinical trial costs, and fees to CROs, expensed as incurred[110](index=110&type=chunk)[112](index=112&type=chunk) - R&D expenses are expected to increase as uproleselan, GMI-1359, and other candidates advance through clinical development[113](index=113&type=chunk) - The duration, costs, and timing of clinical trials are highly uncertain, depending on factors like patient enrollment, trial size, and regulatory requirements[114](index=114&type=chunk) [General and Administrative](index=37&type=section&id=General%20and%20Administrative) This section describes G&A expenses, primarily salaries, stock-based compensation, and professional fees, expected to increase with R&D activities - G&A expenses primarily consist of salaries, stock-based compensation, facility costs, legal fees, and accounting/consulting services, and are anticipated to increase to support R&D activities[116](index=116&type=chunk) [Interest Income](index=37&type=section&id=Interest%20Income) This section states that interest income is earned on cash and cash equivalents - Interest income is earned on cash and cash equivalents[117](index=117&type=chunk) [Results of Operations for the Three and Nine Months Ended September 30, 2021 and 2020](index=37&type=section&id=Results%20of%20Operations%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030%2C%202021%20and%202020) The company experienced a significant decrease in revenue and an increase in net loss for both the three and nine months ended September 30, 2021, compared to the prior year. This was driven by lower collaboration and license revenue and increased research and development expenses, partially offset by stable general and administrative expenses | Metric (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Change ($) | Change (%) | | :-------------------- | :------------------------------ | :------------------------------ | :--------- | :--------- | | Revenue | $87 | $1,000 | $(913) | (91)% | | R&D expense | $13,282 | $10,670 | $2,612 | 24% | | G&A expense | $4,142 | $4,058 | $84 | 2% | | Loss from operations | $(17,337) | $(13,728) | $(3,609) | 26% | | Net loss | $(17,332) | $(13,723) | $(3,609) | 26% | | Metric (in thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | Change ($) | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Revenue | $1,142 | $10,000 | $(8,858) | (89)% | | R&D expense | $34,596 | $33,209 | $1,387 | 4% | | G&A expense | $12,567 | $12,732 | $(165) | (1)% | | Loss from operations | $(46,021) | $(35,941) | $(10,080) | 28% | | Net loss | $(46,006) | $(35,464) | $(10,542) | 30% | [Revenue](index=38&type=section&id=Revenue_Results) This section details the significant decrease in revenue for 2021, primarily due to the recognition of upfront and milestone payments in 2020 - Revenue for the nine months ended September 30, 2021, was **$1.1 million**, down from **$10.0 million** in 2020, primarily due to the recognition of a **$9.0 million** upfront payment and a **$1.0 million** milestone payment from Apollomics in 2020[119](index=119&type=chunk) - The **$1.1 million** revenue in 2021 was from the sale of clinical supplies to Apollomics[119](index=119&type=chunk) [Research and Development Expense](index=38&type=section&id=Research%20and%20Development%20Expense_Results) This section analyzes the increase in R&D expense, driven by higher clinical trial and manufacturing costs, partially offset by lower personnel expenses | R&D Expense (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Change ($) | Change (%) | | :------------------------- | :------------------------------ | :------------------------------ | :--------- | :--------- | | Clinical development | $5,105 | $3,885 | $1,220 | 31% | | Manufacturing & formulation | $4,106 | $2,160 | $1,946 | 90% | | Personnel-related | $2,336 | $2,825 | $(489) | (17)% | | Stock-based compensation | $586 | $763 | $(177) | (23)% | | **Total R&D expense** | **$13,282** | **$10,670** | **$2,612** | **24%** | | R&D Expense (in thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | Change ($) | Change (%) | | :------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Uproleselan | $21,064 | $19,939 | $1,125 | 6% | | GMI-1359 | $509 | $264 | $245 | 93% | | Other R&D | $4,026 | $2,723 | $1,303 | 48% | | Personnel-related & stock-based compensation | $8,997 | $10,283 | $(1,286) | (13)% | | **Total R&D expense** | **$34,596** | **$33,209** | **$1,387** | **4%** | - R&D expense increased by **$2.6 million** (Q3) and **$1.4 million** (YTD) primarily due to higher clinical trial costs for uproleselan, increased manufacturing costs for validation batches, and increased toxicity studies for GMI-1687, partially offset by decreased personnel-related and stock-based compensation[121](index=121&type=chunk) [General and Administrative Expense](index=40&type=section&id=General%20and%20Administrative%20Expense_Results) This section explains the consistent G&A expenses, with decreased personnel costs offset by increased recruiting and legal fees | G&A Expense (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Change ($) | Change (%) | | :------------------------- | :------------------------------ | :------------------------------ | :--------- | :--------- | | Personnel-related | $1,257 | $1,578 | $(321) | (20)% | | Stock-based compensation | $1,005 | $927 | $78 | 8% | | Legal, consulting & other professional expenses | $1,705 | $1,390 | $315 | 23% | | **Total G&A expense** | **$4,142** | **$4,058** | **$84** | **2%** | - G&A expenses remained consistent for both periods. A decrease in personnel-related expenses due to a reversal of bonus accruals for the prior CEO was offset by increased recruiting and legal expenses related to the CEO transition[122](index=122&type=chunk) [Interest Income](index=40&type=section&id=Interest%20Income_Results) This section reports a decrease in interest income due to lower average cash balances and reduced interest rates - Interest income decreased for both the three and nine months ended September 30, 2021, due to lower average cash balances and reduced interest rates[123](index=123&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's liquidity from equity offerings and collaboration payments, its $101.9 million cash balance, and future capital requirements for drug development - As of September 30, 2021, cash and cash equivalents totaled **$101.9 million**[124](index=124&type=chunk) - The company expects existing cash and cash equivalents to fund operations into the first half of 2023[134](index=134&type=chunk) - Future funding needs are uncertain due to the high risk and variable costs of drug development, requiring additional capital through equity, debt, or collaborations[128](index=128&type=chunk)[129](index=129&type=chunk) [Sources of Liquidity](index=40&type=section&id=Sources%20of%20Liquidity) This section identifies public/private equity offerings and upfront/milestone payments from license agreements as primary sources of liquidity - The company's operations are financed through public/private equity offerings (including at-the-market sales) and upfront/milestone payments from license agreements[124](index=124&type=chunk) - Under the 2020 Sales Agreement, **$9.6 million** in net proceeds were raised from common stock sales during the nine months ended September 30, 2021, with **$86.3 million** remaining available[125](index=125&type=chunk) - The Apollomics agreement provided a **$9.0 million** upfront payment and a **$1.0 million** milestone payment in 2020, with additional milestone and royalty payments contingent on future activities[126](index=126&type=chunk) [Funding Requirements](index=42&type=section&id=Funding%20Requirements) This section outlines primary capital uses and the uncertainties in estimating future drug development and commercialization costs, requiring additional capital - Primary capital uses include compensation, R&D services, clinical costs, regulatory expenses, and general overhead[127](index=127&type=chunk) - The successful development of drug candidates is highly uncertain, making it difficult to estimate future costs and timing for development and commercialization[128](index=128&type=chunk) - Additional capital may be required, potentially leading to stockholder dilution, restrictive debt covenants, or relinquishing rights to drug candidates if funds are not available on reasonable terms[130](index=130&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) [Outlook](index=44&type=section&id=Outlook) This section provides an outlook on the sufficiency of existing cash and cash equivalents to fund operations into the first half of 2023 - Existing cash and cash equivalents are expected to fund operating expenses and capital expenditure requirements into the first half of 2023[134](index=134&type=chunk) [Cash Flows](index=44&type=section&id=Cash%20Flows) This section summarizes the net change in cash and cash equivalents from operating, investing, and financing activities | Cash Flow Activity (in thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(44,683) | $(29,556) | | Net cash used in investing activities | $(13) | $(30) | | Net cash provided by financing activities | $9,585 | $14,255 | | **Net change in cash and cash equivalents** | **$(35,111)** | **$(15,331)** | [Operating Activities](index=44&type=section&id=Operating%20Activities) This section details the increase in net cash used in operating activities, primarily due to ongoing clinical and manufacturing costs - Net cash used in operating activities increased to **$44.7 million** for the nine months ended September 30, 2021, from **$29.6 million** in 2020, primarily due to ongoing clinical and manufacturing costs for uproleselan[136](index=136&type=chunk) [Investing Activities](index=44&type=section&id=Investing%20Activities) This section reports minimal net cash used in investing activities, mainly for computer, office, and laboratory equipment - Net cash used in investing activities was minimal, primarily for computer, office, and laboratory equipment[137](index=137&type=chunk) [Financing Activities](index=44&type=section&id=Financing%20Activities) This section describes net cash provided by financing activities, primarily from common stock sales under the at-the-market facility - Net cash provided by financing activities was **$9.6 million** in 2021, mainly from common stock sales under the at-the-market facility, down from **$14.3 million** in 2020[138](index=138&type=chunk) [Off-Balance Sheet Arrangements](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms that the company does not have any off-balance sheet arrangements - The company does not have any off-balance sheet arrangements[139](index=139&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk exposure is interest rate sensitivity on its cash and cash equivalents. Due to the short-term maturities and low-risk profile of its investments, an immediate 100 basis point change in interest rates would not materially affect the fair market value of its cash equivalents - The primary market risk is interest rate sensitivity on cash and cash equivalents, which are held in interest-bearing money market accounts[141](index=141&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[141](index=141&type=chunk) [Item 4. Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of September 30, 2021, concluding they were effective at a reasonable assurance level. There have been no material changes in internal controls over financial reporting during the quarter - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective as of September 30, 2021, at the reasonable assurance level[144](index=144&type=chunk) - No material changes in internal controls over financial reporting occurred during the fiscal quarter ended September 30, 2021[145](index=145&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides other information, including legal proceedings, risk factors, equity sales, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=46&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 significantly impact its business, operating results, cash flows, or financial condition - The company is not currently a party to any material legal proceedings[146](index=146&type=chunk) - No pending or threatened legal proceedings are known that could have a material adverse effect on the business, operating results, cash flows, or financial condition[146](index=146&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) The company's risk factors have not materially changed from those described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020 - Risk factors have not materially changed from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020[147](index=147&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds to report[148](index=148&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, an executive employment agreement, and certifications under the Sarbanes-Oxley Act - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, a specimen stock certificate, and an Executive Employment Agreement with Harout Semerjian[149](index=149&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act are filed herewith[149](index=149&type=chunk)[150](index=150&type=chunk) [Signatures](index=48&type=section&id=Signatures) This section contains the official signatures for the report, confirming its submission by authorized personnel - The report was signed on November 2, 2021, by Brian M. Hahn, Senior Vice President and Chief Financial Officer of GlycoMimetics, Inc[154](index=154&type=chunk)

Glycobiology-based therapeutics Transforming lives Harout Semerjian President and CEO NASDAQ: GLYC September 2021 © 2021 GlycoMimetics, Inc. All rights reserved. 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. Forward-looking statements are subject to known and un ...

GlycoMimetics, Inc. (NASDAQ:GLYC) Q2 2021 Earnings Conference Call August 5, 2021 8:30 AM ET Company Participants Shari Annes - Investor Relations Rachel King - Chief Executive Officer Eric Feldman - Senior Vice President and Chief Medical Officer Brian Hahn - Senior Vice President and Chief Financial Officer Harout Semerjian - President and Chief Executive Officer Conference Call Participants Edward White - H.C. Wainwright Roger Song - Jefferies Operator Good morning, and thank you all for joining GlycoMim ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. (Exact name of registrant as specified in its charter) Delaware 06-1686563 (State or ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. (Exact name of registrant as specified in its charter) Delaware 06-1686563 (State or ...

Innovation Today, Healing Tomorrow. March 2021 | --- | --- | --- | |-----------|-------|-------| | | | | | CORPORATE | | | 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. Forward-looking statements are subject to known and unknown risks, uncertainties, and other fac ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 Commission file number 001-36177 GlycoMimetics, Inc. (Exact name of Registrant as specified in its charter) Delaware 06-1686563 (State or other jurisdiction of incorporation or organization) 9708 Medical Center Drive Rockville, Maryland 20850 (Address of principal executive offices) ...

GlycoMimetics, Inc. (NASDAQ:GLYC) Q3 2020 Earnings Conference Call November 6, 2020 8:30 AM ET Company Participants Shari Annes - IR Rachel King - CEO Brian Hahn - SVP & CFO Helen Thackray - SVP, Clinical Development & CMO John Magnani - Co-Founder & CSO Conference Call Participants Ed White - H.C. Wainwright Ellen Sands - Stifel Zegbeh Jallah - ROTH Capital Partners Operator Good morning and thank you all for joining GlycoMimetics Corporate Update Conference Call. At this time, all participants are in a li ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. Securities registered pursuant to Section 12(b) of the Act: | Title of each clas ...