GLYCOMIMETICS, INC.

INDEX TO FORM 10-Q


		PAGE

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements		3

Balance Sheets as of ~~September 30, 2017~~March 31, 2023 (unaudited) and December 31, ~~2016~~2022		3

Unaudited Statements of Operations and Comprehensive Loss for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022		4

Unaudited Statements of Stockholders’ Equity for the three months ended March 31, 2023 and 2022		5

Unaudited Statements of Cash Flows for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022		5 6

Notes to Unaudited Financial Statements		6 7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		16 18

Item 3. Quantitative and Qualitative Disclosures about Market Risk		26

Item 4. Controls and Procedures		26

PART II. OTHER INFORMATION

Item 1. Legal Proceedings		27

Item 1A. Risk Factors		27

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds		27

Item ~~6. Exhibits~~5. Other Information		28 27

~~Signatures~~Item 6. Exhibits		28

Signatures		29

Part I. FINANCIAL ~~INFORMATION~~INFORMATION

ITEM 1. FINANCIAL STATEMENTS

~~Item 1. Financial Statements~~

GLYCOMIMETICS, INC.

Balance Sheets

~~Balance Sheets~~


	March 31,		December 31,
	2023		2022
Assets		(Unaudited)
Current assets:
Cash and cash equivalents	$	65,002,342	$	47,870,619
Prepaid expenses and other current assets		3,084,189		2,844,086
Total current assets		68,086,531		50,714,705
Property and equipment, net		200,747		242,390
Prepaid research and development expenses		50,000		50,000
Deposits		52,320		52,320
Operating lease right-of-use asset		532,056		751,174
Total assets	$	68,921,654	$	51,810,589
Liabilities & stockholders’ equity
Current liabilities:
Accounts payable	$	480,151	$	970,191
Accrued expenses		5,608,323		6,992,006
Lease liabilities		651,734		918,555
Total current liabilities		6,740,208		8,880,752
Total liabilities		6,740,208		8,880,752
Stockholders’ equity:
Preferred stock; $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding at March 31, 2023 and December 31, 2022		—		—
Common stock; $0.001 par value; 100,000,000 shares authorized; 64,245,224 shares issued and outstanding at March 31, 2023; 54,377,798 shares issued and outstanding at December 31, 2022		64,245		54,378
Additional paid-in capital		492,062,343		462,461,251
Accumulated deficit		(429,945,142)		(419,585,792)
Total stockholders’ equity		62,181,446		42,929,837
Total liabilities and stockholders’ equity	$	68,921,654	$	51,810,589

September 30,

December 31,

2017

2016

Assets

(Unaudited)

Current assets:

Cash and cash equivalents

$
112,872,534

$
40,041,641

Prepaid expenses and other current assets

1,015,747

478,503

Total current assets

113,888,281

40,520,144

Property and equipment, net

1,122,216

1,056,332

Prepaid research and development expenses

759,531

759,531

Deposits

52,320

52,320

Total assets

$
115,822,348

$
42,388,327

Liabilities & stockholders’ equity

Current liabilities:

Accounts payable

$
1,631,722

$
1,565,210

Accrued bonuses

1,146,497

1,432,485

Accrued expenses

3,678,609

3,267,371

Deferred rent

74,072

68,551

Total current liabilities

6,530,900

6,333,617

Deferred rent, net of current portion

726,986

753,579

Total liabilities

7,257,886

7,087,196

Stockholders’ equity:

Preferred stock; $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding at September 30, 2017 and December 31, 2016

—

—

Common stock; $0.001 par value; 100,000,000 shares authorized, 32,737,799 shares issued and outstanding at September 30, 2017; 100,000,000 shares authorized, 23,250,023 shares issued and outstanding at December 31, 2016

32,736

23,249

Additional paid-in capital

251,550,974

154,254,193

Accumulated deficit

(143,019,248)

(118,976,311)

Total stockholders’ equity

108,564,462

35,301,131

Total liabilities and stockholders’ equity

$
115,822,348

$
42,388,327

The accompanying notes are an integral part of the unaudited financial statements.

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GLYCOMIMETICS, INC.

Unaudited Statements of ~~Operations~~Operations and Comprehensive Loss

Three Months Ended September 30,

Nine Months Ended September 30,

2017

2016

2017

2016

Revenue

$
—

$
18,500

$
—

$
18,500


Costs and expenses:

Research and development expense

5,779,759

5,921,461

17,380,337

17,221,360

General and administrative expense

2,401,976

1,983,795

7,016,081

6,352,355

Total costs and expenses

8,181,735

7,905,256

24,396,418

23,573,715

Loss from operations

(8,181,735)

(7,886,756)

(24,396,418)

(23,555,215)

Other income

231,634

32,063

373,208

73,974

Net loss and comprehensive loss

$
(7,950,101)

$
(7,854,693)

$
(24,023,210)

$
(23,481,241)

Basic and diluted net loss per common share

$
(0.24)

$
(0.34)

$
(0.86)

$
(1.14)

Basic and diluted weighted average number of common shares

32,724,010

23,049,347

27,814,781

20,638,129


	Three Months Ended March 31,
	2023		2022

Costs and expenses:
Research and development expense	$	5,418,706	$	9,603,922
General and administrative expense		5,522,312		5,056,188
Total costs and expenses		10,941,018		14,660,110
Loss from operations		(10,941,018)		(14,660,110)
Interest income		581,668		7,069
Net loss and comprehensive loss	$	(10,359,350)	$	(14,653,041)
Basic and diluted net loss per common share	$	(0.17)	$	(0.28)
Basic and diluted weighted-average number of common shares outstanding		60,350,127		52,331,391

The accompanying notes are an integral part of the unaudited financial statements.

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GLYCOMIMETICS, INC.

Unaudited Statements of ~~Cash Flows~~Stockholders’ Equity

Nine Months Ended September 30,

2017

2016

Operating activities

Net loss

$
(24,023,210)

$
(23,481,241)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation

193,976

139,749

Stock-based compensation expense

2,796,301

2,238,647

Changes in assets and liabilities:

Prepaid expenses and other current assets

(537,244)

(797,906)

Prepaid research and development expenses

—

(63,000)

Deposits

—

(52,320)

Accounts payable

66,512

682,504

Accrued expenses and bonuses

125,250

(3,122,258)

Deferred rent

(21,072)

679,177

Net cash used in operating activities

(21,399,487)

(23,776,648)

Investing activities

Purchases of property and equipment

(259,860)

(265,635)

Net cash used in investing activities

(259,860)

(265,635)

Financing activities

Proceeds from issuance of common stock, net of issuance costs

94,269,213

22,453,785

Proceeds from exercise of stock options

221,027

68,488

Net cash provided by financing activities

94,490,240

22,522,273

Net change in cash and cash equivalents

72,830,893

(1,520,010)

Cash and cash equivalents, beginning of period

40,041,641

46,802,560

Cash and cash equivalents, end of period

$
112,872,534

$
45,282,550

Non-cash investing activities

Property acquisition costs included in accounts payable and accrued expenses

$
—

$
29,329


				Additional				Total
	Common Stock			Paid-In		Accumulated		Stockholders’
	Shares	Amount		Capital		Deficit		Equity
Balance at December 31, 2022	54,377,798	$	54,378	$	462,461,251	$	(419,585,792)	$	42,929,837
Issuance of common stock, net of issuance costs	9,822,930		9,823		28,697,188		—		28,707,011
Exercise of options and vesting of restricted stock units	44,496		44		33,724		—		33,768
Stock-based compensation	—		—		870,180		—		870,180
Net loss	—		—		—		(10,359,350)		(10,359,350)
Balance at March 31, 2023	64,245,224	$	64,245	$	492,062,343	$	(429,945,142)	$	62,181,446

				Additional				Total
	Common Stock			Paid-In		Accumulated		Stockholders’
	Shares	Amount		Capital		Deficit		Equity
Balance at December 31, 2021	52,313,894	$	52,314	$	454,448,327	$	(372,896,990)	$	81,603,651
Vesting of restricted stock units	78,550		78		(78)		—		—
Stock-based compensation	—		—		1,080,642		—		1,080,642
Net loss	—		—		—		(14,653,041)		(14,653,041)
Balance at March 31, 2022	52,392,444	$	52,392	$	455,528,891	$	(387,550,031)	$	68,031,252

The accompanying notes are an integral part of the unaudited financial statements.

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GLYCOMIMETICS, INC.

Unaudited Statements of Cash Flows


	Three Months Ended March 31,
	2023		2022
Operating activities
Net loss	$	(10,359,350)	$	(14,653,041)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		43,839		59,308
Non-cash lease expense		219,119		198,814
Stock-based compensation		870,180		1,080,642
Changes in assets and liabilities:
Prepaid expenses and other current assets		(240,103)		(413,588)
Prepaid research and development expenses		—		(660,800)
Accounts payable		(490,040)		168,558
Accrued expenses		(1,383,683)		761,658
Lease liabilities		(266,821)		(239,694)
Net cash used in operating activities		(11,606,859)		(13,698,143)

Investing activities
Purchases of property and equipment		(2,197)		(40,521)
Net cash used in investing activities		(2,197)		(40,521)

Financing activities
Proceeds from issuance of common stock, net of issuance costs		28,707,011		—
Proceeds from exercise of stock options		33,768		—
Net cash provided by financing activities		28,740,779		—
Net change in cash and cash equivalents		17,131,723		(13,738,664)
Cash and cash equivalents, beginning of period		47,870,619		90,254,890
Cash and cash equivalents, end of period	$	65,002,342	$	76,516,226

The accompanying notes are an integral part of the unaudited financial statements.

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GLYCOMIMETICS, INC.

Notes to Unaudited Financial ~~Statements~~Statements

1. Description of the Business

GlycoMimetics, Inc. (the Company), a Delaware corporation headquartered in Rockville, Maryland, was incorporated ~~on April 4, 2003 and commenced operations on May 21,~~in 2003. The Company is a late-stage clinical ~~stage~~development biotechnology company focused on improving the ~~discovery~~lives of people living with cancer and ~~development~~inflammatory diseases by leveraging the inhibition of ~~novel glycomimetic drugs to address unmet medical needs resulting from diseases in~~carbohydrate interactions that occur on the surface of cells. The Company is developing a pipeline of proprietary glycomimetics, which ~~carbohydrate biology plays a key role. Glycomimetics~~ are small molecules that mimic the structure of carbohydrates involved in important biological processes. The Company’s proprietary glycomimetics platform is based on its expertise in carbohydrate chemistry and its understanding of the role carbohydrates play in key biological processes. Using this expertise and understanding, the Company is developing a pipeline of proprietary glycomimetics designedprocesses, to inhibit disease-related functions of carbohydrates such as the roles they play in inflammation, cancer and infection.

The Company’s executive personnel have devoted substantially all of their time to date to the planning and organization of the Company, the process of hiring scientists, initiating research and development programs and securing adequate capital for anticipated growth and operations. The Company has not commercialized any of its drug candidates ~~or commenced~~and planned commercial ~~operations.~~operations have not commenced. The Company ~~is subject to a number of risks similar to those of other companies~~has incurred significant losses in similar development stages, including dependence on key individuals, the need to develop commercially viable drugs, competition from other companies, many of whom are larger and better capitalized, and the need to obtain adequate additional financing to fund the development of its drug candidates. The Company has ~~incurred significant operating losses since inception and~~not generated revenues from product sales. As a result, the Company has ~~relied on its ability to fund its operations through private and public equity financings, and management expects operating losses and~~consistently reported negative ~~operating~~ cash flows from operating activities and net losses, had an accumulated deficit of $429.9 million at March 31, 2023 and expects to continue incurring losses for the foreseeable future. ~~As the~~

The Company ~~continues to incur losses, profitability~~believes that its existing cash and cash equivalents as of March 31, 2023 will be ~~dependent upon the successful development, approval, and commercialization of its drug candidates and achieving a level of revenues adequate~~sufficient to ~~support~~fund the Company’s ~~cost structure. The Company may never achieve profitability, and unless and until it does,~~operations for at least 12 months from the ~~Company will continue to need to raise additional capital.~~issuance of these financial statements. Management intends to fund future operations through additional public or private equity or debt offerings and may seek additional capital through arrangements with strategic partners or from other ~~sources.~~sources, the securing of which cannot be assured.

2. Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the United States Securities and Exchange Commission (the SEC) on March 29, 2023 (the Form 10-K).

Basis of Accounting

The accompanying unaudited financial statements were prepared based on the accrual method of accounting in accordance with U.S. generally accepted accounting principles (GAAP).

Unaudited Financial Statements

The accompanying balance sheet as of ~~September 30, 2017 and~~March 31, 2023, statements of operations and comprehensive loss and stockholders’ equity for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022 and statements of cash flows for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022 are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the ~~United States Securities and Exchange Commission (the SEC)~~SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete annual financial statements. These unaudited financial statements should be read in conjunction with the audited financial statements and the accompanying notes for the year ended December 31, ~~2016~~2022 contained in the ~~Company’s Annual Report on~~ Form ~~10-K filed with the SEC on March 1, 2017.~~10-K. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and in the opinion of management reflect all adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of ~~September 30, 2017, the~~March 31, 2023, its results of operations and changes in its stockholders’ equity for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022 and its cash flows for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2023 and ~~2016.~~2022. The December 31, ~~2016~~2022 balance sheet included herein was derived from audited financial statements, but does not include all disclosures including notes required by GAAP for complete annual financial statements. The financial data and other information disclosed in these notes to the financial statements related to the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022 are unaudited. Interim results are not necessarily indicative of results for an entire ~~year.~~

year or for any future period.

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Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Although actual results could differ from those estimates, management does not believe that such differences would be material.

Fair Value Measurements

The Company had no assets or liabilities that were measured using quoted prices for similar assets and liabilities or significant unobservable inputs (Level 2 and Level 3 assets and liabilities, respectively) as of ~~September 30, 2017~~March 31, 2023 and December 31, ~~2016.~~2022. The carrying value of cash held in money market funds of ~~approximately $110.9~~$63.0 million and ~~$38.0~~$45.9 million as of ~~September 30, 2017~~March 31, 2023 and December 31, ~~2016,~~2022, respectively, is included in cash and cash equivalents and approximates market values based on quoted market prices (Level 1 inputs). The Company did not transfer any assets measured at fair value on a recurring basis between levels during the three months ended March 31, 2023 and 2022.

Concentration of Credit Risk

Credit risk represents the risk that the Company would incur a loss if counterparties failed to perform pursuant to the terms of their agreements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. ~~Cash~~The Company maintains its cash balances with financial institutions in federally insured accounts and has cash balances in excess of the insurance limits. Cash equivalents consist of investment in United States government money market funds with major financial ~~institutions in the United States.~~institutions. These deposits and funds may be redeemed upon demand and ~~therefore, bear minimal risk. The~~the Company does not anticipate any losses on such balances.

~~Revenue Recognition~~

From time to time, the Company is awarded reimbursement contracts for services and development grant contracts with government and non-government entities and philanthropic organizations. Under these contracts, the Company typically is reimbursed for the costs in connection with specific development activities. The Company ~~recognizes revenue~~has not experienced any losses to ~~the extent of costs incurred in connection with performance under such grant arrangements.~~date and believes that it is not exposed to any significant credit risk on cash and cash equivalents.

Revenue Recognition

The Company ~~has entered into a collaborative research~~applies Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers (Topic 606), to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and ~~development agreement~~financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods and services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with ~~Pfizer Inc. (Pfizer). The agreement is~~the customer(s); (ii) identify the performance obligations in the ~~form~~contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of aTopic 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

The Company enters into licensing agreements which are within the scope of Topic 606, under which it licenses certain of its drug candidates’ rights to third parties. The terms of these arrangements typically include payment of one or more of the following: non-refundable, up-front license ~~agreement (the Pfizer Agreement). The Pfizer Agreement calls for a nonrefundable up-front payment~~fees; development, regulatory and commercial milestone ~~payments upon achieving significant milestone events. The Pfizer Agreement also contemplates royalty payments~~payments; and royalties on ~~future~~net sales of ~~an approved product. There are no performance, cancellation, termination, or refund provisions in~~ the ~~Pfizer Agreement~~licensed product, if and when earned. See Note 10 for additional information regarding the Company’s license agreements.

In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps under Topic 606 described above. As part of the accounting for these arrangements, the Company must develop assumptions that ~~contain material financial consequences~~require judgment to determine the ~~Company.~~stand-alone selling price,

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which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success.

~~The primary deliverable under this arrangement is an exclusive worldwide~~Licensing of Intellectual Property: If the license to the Company’s ~~rivipansel compound, but~~intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, ~~also includes deliverables related to research and preclinical development activities to be performed by~~ the Company ~~on Pfizer’s behalf.~~

~~Collaborative research and development agreements can provide for one or more of~~recognizes revenue from non-refundable, up-front ~~license~~ fees ~~research payments, and milestone payments. Agreements with multiple components (deliverables or items) are evaluated according~~allocated to the ~~provisions~~license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of ~~Accounting Standards Codification (ASC) 605-25,~~ ~~Revenue Recognition—Multiple-Element Arrangements~~,the combined performance obligation to determine whether the ~~deliverables can be separated into more than one unit~~combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of ~~accounting. An item can generally be considered a separate unit~~measuring progress for purposes of accounting if all of the following criteria are met: (1) the delivered item(s) has value to the customer on a stand-alone basis and (2) if the arrangement includes a general right of return relative to the delivered item(s) then delivery or performance of the undelivered item(s) is considered probable and substantially in control of the Company. Items that cannot be divided into separate units are combined with other units of accounting, as appropriate. Consideration received is allocated among the separate units based on selling price hierarchy. The selling price hierarchy for each deliverable is based on (i) vendor-specific objective evidence (VSOE), if available; (ii) third-party evidence (TPE) of selling price if VSOE is not available; or (iii) an estimated selling price, if neither VSOE nor TPE is available. Management was not able to establish VSOE or TPE for separate unit deliverables, as the Company does not have a history of entering into such arrangements or selling the individual deliverables within such arrangements separately. In addition, there may be significant differentiation in these arrangements, which indicates that comparable third-party pricing may not be available. Management determined that the selling price for the

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deliverables within the Pfizer Agreement should be determined using its best estimate of selling price. The process of determining the best estimate of selling price involved significant judgment on the Company’s part and included consideration of multiple factors such as estimated direct expenses, other costs, and available clinical development data.

Pursuant to ASC 605-25, each required deliverable under the Pfizer Agreement is evaluated to determine whether it qualifies as a separate unit of accounting. Factors considered in this determination include the research capabilities of Pfizer, the proprietary nature of the license and know-how, and the availability of the Company’s glycomimetics technology research expertise in the general marketplace. Based on all relevant facts and circumstances and, most significantly, on the proprietary nature of the Company’s technology and the related proprietary nature of the Company’s research services, management concluded that stand-alone value does not exist for the license, and therefore, the license is not a separate unit of accounting under the Pfizer Agreement and will be combined with the research and development services (including participation on a joint steering committee).recognizing revenue from non-refundable, up-front fees. The Company ~~has satisfied~~evaluates the ~~deliverables under~~measure of progress each reporting period, and, if necessary, adjusts the ~~Pfizer Agreement.~~measure of performance and related revenue recognition.

~~Pursuant to ASC 605-28,~~ ~~Revenue Recognition—~~Milestone ~~Method~~~~, at~~Payments: At the inception of ~~agreements~~each arrangement that ~~include~~includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration and other revenues and earnings in their period of adjustment.

Royalties: For arrangements that include sales-based royalties, including milestone ~~is substantive and at risk to both parties~~payments based on the ~~basis~~level of sales, and for which the ~~contingent nature~~license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the ~~milestone. This evaluation includes an assessment of whether (a)~~related sales occur or (ii) when the ~~consideration is commensurate with either (1) the entity’s~~ performance obligation to ~~achieve the milestone,~~which some or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the ~~deliverables~~royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements.

Manufacturing and ~~payment terms within~~Supply: The obligations under the Company’s agreements may include clinical and/or commercial manufacturing products to be provided by the Company to the counterparty. The services are generally determined to be distinct from the other promises or performance obligations identified in the arrangement. ~~In making this assessment,~~The Company recognizes the transaction price allocated to these services as revenue at a point in time when transfer of control of the related products to the customer occurs.

Accruals for Clinical Trial Expenses

Clinical trial costs primarily consist of expenses incurred under agreements with contract research organizations (CROs), investigative sites, laboratory testing expenses, data management and consultants that conduct the Company's clinical trials. Clinical trial expenses are a significant component of research and development expenses, and the Company ~~evaluates factors~~outsources a significant portion of these clinical trial activities to third parties. The accrual for site and patient costs includes inputs such as ~~scientific, regulatory, commercial~~estimates of patient enrollment, patient cycles incurred, clinical site activations, estimated project duration and other ~~risks that must be overcome to achieve the respective milestone, the level of effort and investment~~pass-through costs. These inputs are required to ~~achieve~~be estimated due to a lag in receiving the ~~respective milestone~~actual clinical information from third parties. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and ~~whether~~are reflected on the ~~milestone consideration is reasonable relative to all deliverables and payment terms in the agreement.~~

~~Non-refundable development and regulatory milestones that are expected to be achieved~~balance sheets as a ~~result~~prepaid asset or accrued expenses. These third-party agreements are generally cancellable, and related costs are recorded as research and development expenses as incurred. Except for payments made in advance of services, clinical trial costs are expensed as incurred. Non-refundable advance clinical payments for goods or services that will be used or rendered for future research and development activities are recorded as a prepaid asset and recognized as expense as the related goods are delivered or the related services are performed. When evaluating the adequacy of the Company’s efforts during the period of substantial involvement are recognized as revenue upon the achievement of the milestone, assuming all other revenue recognition criteria are met. Milestones that are not considered substantive because the Company does not contribute effort to the achievement of such milestones are generally achieved after the period of substantial involvement and are recognized as revenue upon achievement of the milestone, as there are no undelivered elements remaining and no continuing performance obligation, assuming all other revenue recognition criteria are met. In May 2014, the Company recognized $15.0 million in revenue as a result of the first non-refundable milestone payment received from Pfizer. In June 2015, the Company recognized $20.0 million in revenue as a result of Pfizer dosing the first patient in the Phase 3 clinical trial of rivipansel, which triggered the second non-refundable milestone payment.

~~Accrued Liabilities~~

~~The Company is required to estimate~~ accrued liabilities as part of the process of preparing its financial statements. The estimation of accrued liabilities involves identifying services that have been performed on the Company’s behalf, and then estimating the level of service performed and the associated cost incurred for such services as of each balance sheet date. Accrued liabilities include professional service fees, such as for lawyers and accountants, contract service fees, such as those under contracts with clinical monitors, dataexpenses, management organizations and investigators in conjunction with clinical trials, and fees to contract manufacturers in conjunction with the production of clinical materials. Pursuant to the Company’s assessment of the services that have been performed, the Company recognizes these expenses as the services are provided. Such assessments include: (i) an evaluation by the project manager of the work that has been completed during the period; (ii) measurement of progress prepared internally and/or provided by the third-party service provider; (iii) analyses of data that justify the progress; and (iv) the Company’s judgment.

~~Research~~ Significant judgments and ~~Development Costs~~

~~Except for payments~~estimates may be made in ~~advance~~determining the accrued balances at the end of ~~services, research and development costs are expensed as incurred. For payments made in advance,~~any reporting period. Actual results could differ from the ~~Company recognizes research and development expense as~~estimates made. The Company’s historical clinical accrual estimates have not been materially different from the services are rendered. Research and development costs primarily consist of salaries and related expenses for personnel, laboratory supplies and raw materials, sponsored research, depreciation of laboratory facilities and leasehold improvements, and utilities costsactual costs.

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related to research space. Other research and development expenses include fees paid to consultants and outside service providers including clinical research organizations and clinical manufacturing organizations.

Stock-Based Compensation

Stock-based payments are accounted for in accordance with the provisions of ASC 718, Compensation—Stock Compensation. The fair value of stock-based payments is estimated, on the date of grant, using the Black-Scholes-Merton model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. The Company accounts for forfeitures as they occur.

The Company has elected to use the Black-Scholes-Merton option pricing model to value any options granted. The Company will reconsider use of the Black-Scholes-Merton model if additional information becomes available in the future that indicates another model would be more appropriate or if grants issued in future periods have characteristics that prevent their value from being reasonably estimated using this model.

A discussion of management’s methodology for developing some of the assumptions used in the valuation model follows:

Expected Dividend Yield—The Company has never declared or paid dividends and has no plans to do so in the foreseeable future.

Expected Volatility—Volatility is a measure of the amount by which a financial variable such as share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. ~~Prior to~~The Company bases the expected volatility on the historical volatility of the Company’s initial public offering, there was not a market for the Company’s shares. The Company utilizes the historical volatilities of a peer group (e.g., several public entities of similar size, complexity, and stage of development), along with the Company’s historical volatility since its initial public offering, to determine its expected volatility.publicly traded common stock.

Risk-Free Interest Rate—This is the U.S. Treasury rate for the week of each option grant during the year, having a term that most closely resembles the expected life of the option.

Expected Term—This is a period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected life of the option term to be 6.25 years. The Company uses a simplified method to calculate the average expected term.

~~Expected Forfeiture Rate—Effective on January 1, 2017 with the adoption of ASU 2016-09,~~ ~~Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, the Company elected to account for forfeitures as they occur.~~

Net Loss Per Common Share

Basic net loss per common share is determined by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock options and restricted stock units ~~and warrants.~~(RSUs).

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~~Basic and diluted net loss per common share is computed as follows:~~

Three Months Ended September 30,

Nine Months Ended September 30,

2017

2016

2017

2016
Net loss

$
(7,950,101)

$
(7,854,693)

$
(24,023,210)

$
(23,481,241)
Basic and diluted net loss per common share

$
(0.24)

$
(0.34)

$
(0.86)

$
(1.14)
Basic and diluted weighted average common shares outstanding

32,724,010

23,049,347

27,814,781

20,638,129

The following potentially dilutive securities outstanding have been excluded from the computation of diluted ~~weighted average~~weighted-average common shares outstanding, as they would be anti-dilutive:

Three Months Ended September 30,

Nine Months Ended September 30,


2017

2016

2017

2016
Warrants

553,868

555,412

553,868

555,412
Stock options and restricted stock units

3,421,124

2,815,166

3,421,124

2,815,166


	Three Months Ended March 31,
	2023	2022
Stock options and RSUs	11,420,012	9,789,833

Comprehensive Loss

Comprehensive loss comprises net loss and other changes in equity that are excluded from net loss. For the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016,~~2022, the Company’s net loss equaled comprehensive net loss and, accordingly, no additional disclosure is presented.

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Recently Issued Accounting Standards

~~Adopted Accounting Standards~~

~~In March 2016, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-09,~~ ~~Compensation – Stock Compensation~~ (~~Topic 718~~): ~~Improvements to Employee Share-Based Payment Accounting~~. This ASU includes provisions intended to simplify various aspects related to how share-based payments are accounted for and presented in financial statements including the income tax effects of share-based payments, minimum statutory withholding requirements and forfeitures. The new guidance requires all income tax effects of awards to be recognized in the income statement when the awards vest or are settled. It also allows an employer to repurchase more of an employee’s shares than the current standard for tax withholding purposes without triggering liability accounting and to make a policy election to account for forfeitures as they occur. The Company adopted the provisions of ASU 2016-09 on January 1, 2017. The Company has elected to account for forfeitures as they occur. The Company has applied this change using a modified retrospective method through a cumulative-effect adjustment of $19,727 to accumulated deficit. Additionally, the Company recognized deferred tax assets of $98,767 for the excess tax benefits that arose directly from tax deductions related to equity compensation greater than the amounts recognized for financial reporting and also recognized an increase of an equal amount in the valuation allowance against those deferred tax assets. The Company has adopted the additional provisions in the standard and has determined these provisions do not have a material impact on the financial statements.

Accounting Standards Not Yet Adopted

~~On May 28, 2014, the FASB issued ASU No. 2014-09,~~ ~~Revenue from Contracts with Customers~~ (~~Topic 606~~), requiring an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The updated standard will replace most existing revenue recognition guidance in GAAP when it becomes effective and permits the use of either the retrospective or cumulative effect transition method. In August 2015, the FASB issued ASU No. 2015-14, ~~Revenue from Contracts with Customers: Deferral of the Effective Date~~, which deferred the effective date of the new revenue standard for periods beginning after December 15, 2016 to December 15, 2017, with early adoption permitted but not earlier than the original effective date. Accordingly, the updated standard is effective for the Company in the first quarter of fiscal 2018. The Company has evaluated the Pfizer Agreement to determine the impact of the new revenue standard on the upfront and milestone payments within the Pfizer Agreement and has determined that the transition to the new revenue standard will have no material impact on the

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~~financial statements.~~ ~~The Company expects to adopt the new standard on January 1, 2018 using the full retrospective transition method.~~

~~In February 2016, the FASB issued ASU No. 2016-02,~~ ~~Leases (Topic 842), which supersedes existing guidance on accounting for leases in~~ ~~Leases (Topic 840)~~ and generally requires all leases, including operating leases, to be recognized in the statement of financial position as right-of-use assets and lease liabilities by lessees. The provisions of ASU 2016-02 are to be applied using a modified retrospective approach and are effective for reporting periods beginning after December 15, 2018; early adoption is permitted. The Company is currently evaluating the effect that this ASU will have on the financial statements.

~~With the exception of the new standards discussed above, there~~There have been no new accounting pronouncements that have significance, or potential significance, to the Company’s unaudited financial ~~statements.~~statements for the quarter ended March 31, 2023.

3. Prepaid Expenses and Other Current Assets

The following is a summary of the Company’s prepaid expenses and other current assets:


	September 30,		December 31,
	2017		2016
Prepaid expenses	$	940,099	$	199,195

					March 31,		December 31,
					2023		2022
Prepaid research and development expenses					$	2,290,997	$	2,300,209
Other prepaid expenses						559,078		399,861
Other receivables		75,648		268,659		234,114		144,016
Deposits		—		10,649
Prepaid expenses and other current assets	$	1,015,747	$	478,503	$	3,084,189	$	2,844,086

4. Property and Equipment

Property and equipment, net consists of the following:


	September 30,		December 31,
	2017		2016

					March 31,		December 31,
					2023		2022
Furniture and fixtures	$	314,024	$	262,135	$	342,203	$	342,203
Laboratory equipment		1,282,655		1,130,180		1,343,081		1,343,081
Office equipment		11,084		6,610		17,762		17,762
Computer equipment		191,825		169,423		312,022		309,826
Leasehold improvements		573,165		36,128		616,133		616,133
Construction in progress		—		508,417
Property and equipment		2,372,753		2,112,893		2,631,201		2,629,005
Less accumulated depreciation		(1,250,537)		(1,056,561)		(2,430,454)		(2,386,615)
Property and equipment, net	$	1,122,216	$	1,056,332	$	200,747	$	242,390

Depreciation expense was ~~$70,060~~$43,839 and ~~$45,808~~$59,308 for the three months ended ~~September 30, 2017~~March 31, 2023 and ~~2016, respectively, and $193,976 and $139,749 for the nine months ended September 30, 2017 and 2016,~~2022, respectively.

5. Accrued Expenses

The following is a summary of the Company’s accrued expenses:

September 30,

December 31,

2017

2016

Accrued research and development expenses

$
2,727,309

$
2,513,243

Accrued consulting and other professional fees

371,595

148,579

Other accrued expenses

187,067

315,002

Accrued employee benefits

392,638

290,547

Accrued expenses

$
3,678,609

$
3,267,371


	March 31,		December 31,
	2023		2022
Accrued research and development expenses	$	2,890,743	$	3,484,742
Accrued bonuses		1,099,682		2,664,613
Accrued consulting and other professional fees		658,765		499,592
Accrued employee benefits		903,943		300,653
Other accrued expenses		55,190		42,406
Accrued expenses	$	5,608,323	$	6,992,006

6. Leases

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company determines a lease exists if the contract conveys the right to control an identified asset for a period of time in exchange for consideration. Control is considered to exist when the lessee has the

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right to obtain substantially all of the economic benefits from the use of an identified asset as well as direct the right to use of that asset. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less on the lease commencement date. If a contract is considered to be a lease, the Company recognizes a lease liability based on the present value of the future lease payments over the expected lease term, with an offsetting entry to recognize a right-of-use asset.

~~6. Operating Leases~~The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a term similar to the term of the lease for which the rate is estimated. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.

The Company leases office and research space in Rockville, Maryland under an operating lease with a term from June 15, 2015 through October 31, 2023 ~~(as amended to date, the~~(the Lease) that is subject to annual rent increases. The Company has the right to sublease or assign all or a portion of the premises, subject to the conditions set forth in the Lease. The Lease may be terminated early by either the landlord or the Company in certain circumstances. In connection with the Lease, the Company received rent abatement as a lease ~~incentive. The annual rent increases and rent abatement have been recognized as deferred rent that is being adjusted on a straight-line basis over~~incentive in the ~~term~~initial year of the Lease.

In March 2016, the Company amended the Lease (the Lease Amendment) to lease additional space as of June 1, 2016. In ~~addition to the other terms of the Lease, the Lease Amendment provided for a tenant improvement allowance~~ ~~reflected in the Company’s financial statements as an increase in capitalized leasehold improvements as incurred and an increase in deferred rent. In~~ May 2016, the Company also paid a security deposit of $52,320 to be held until the expiration or termination of the Company’s obligations under the Lease. The term of the Lease Amendment for the additional space continues through October 31, 2023, the same date as for the premises originally leased under the ~~Lease, subject~~Lease. Subsequent to March 31, 2023, the ~~Company’s renewal option set forth~~lease was amended to extend the term with respect to a portion of the premises (see Note 10).

The Company identified and applied the following significant assumptions in recognizing the ~~Lease. The Company’s one-time option to terminate~~right-of-use asset and corresponding liability for the Lease ~~effective as~~and Lease Amendment:

●

Lease term – The lease term includes both the noncancelable period and, when applicable, cancelable option periods where failure to exercise such option would result in an economic penalty.

●

Incremental borrowing rate – As the Company’s lease does not provide an implicit rate, the Company used an incremental borrowing rate, or IBR, which is the rate incurred to borrow on a collateralized basis over a term similar to the term of the lease for which the rate is estimated. The Company determined the IBR to be 8.0% based on an estimated rate that considered the Company’s credit risk in the United States for a collateralized borrowing and term similar to the Lease.

As of ~~October~~March 31, ~~2020 also applies to~~2023, the ~~additional space.~~

~~Deferred rent related to the Lease~~weighted-average remaining lease term was ~~$801,058 and $822,130 at September 30, 2017 and December 31, 2016, respectively. Total rent expense under the Company’s~~0.6 years. There were no additional operating leases ~~was $223,337 and $219,983 for~~entered into during the three months ended ~~September 30, 2017~~March 31, 2023.

The components of lease expense and ~~2016, respectively, and $667,507 and $557,262 for the nine months ended September 30, 2017 and 2016, respectively.~~related cash flows were as follows:


	Three Months Ended March 31,
	2023		2022
Operating lease cost	$	231,989	$	231,989
Variable lease cost		183,274		151,132
Total operating lease cost	$	415,263	$	383,121

Cash paid for amounts included in the measurement of lease liabilities:
Operating cash outflows for operating leases	$	279,692	$	272,870

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Maturities of lease liability due under these lease agreements as of March 31, 2023 were as follows:


	Operating Lease
	Obligation
April 1, 2023 - December 31, 2023	$	661,150
Thereafter		—
Total		661,150
Present value adjustment		(9,416)
Present value of lease payments	$	651,734

7. Stockholders’ Equity

At-The-Market ~~Equity Offering~~Sales Facility

OnIn March ~~1, 2016,~~2022, the Company ~~entered into~~filed a shelf registration statement with the SEC, which was declared effective on April 22, 2022. On April 28, 2022, the Company terminated an at-the-market sales agreement previously entered into with Cowen and Company, LLC ~~to sell the Company’s securities under~~(Cowen) in 2020 and entered into a ~~shelf registration statement filed in March 2015. The at-the market~~new at-the-market sales agreement ~~was terminated on May 23, 2017.~~(the 2022 Sales Agreement) with Cowen. Under the 2022 Sales Agreement, the Company may sell up to $100.0 million worth of shares of common stock. During the ~~nine months~~year ended ~~September 30, 2017,~~December 31, 2022, the Company issued and sold ~~1,388,647~~1,953,854 shares of common stock under the ~~at-the-market sales agreement. The shares were sold~~2022 Sales Agreement at a weighted average price per share of ~~$5.55,~~$2.22, for aggregate net proceeds of ~~$7.4~~$4.2 million, after deducting commissions and offering expenses.

~~On September 28, 2017,~~During the Company entered into a new at-the-market sales agreement with Cowen and Company, LLC to sell the Company’s securities under a shelf registration statement filed in September 2017. Subsequent to September 30, 2017,quarter ended March 31, 2023, the Company issued and sold ~~1,600,000~~9,822,930 shares of common stock under the ~~at-the-market sales agreement. The shares were sold~~2022 Sales Agreement at a weighted average price per share of ~~$12.50,~~$3.01, for aggregate net proceeds of ~~$19.2~~$28.7 million, after deducting commissions and offering expenses.

~~Equity Offering~~

~~In May 2017,~~ As of March 31, 2023, approximately $66.0 million remained available to be sold under the Company completed a public offering in which the Company sold 8,050,000 shares of its common stock at a price to the public of $11.50 per share. The Company received net proceeds of $86.8 million from this offering, after deducting underwriting discounts, commissions and other offering expenses.

~~2003 Stock Incentive Plan~~

The 2003 Stock Incentive Plan (the 2003 Plan) provided for the grant of incentives and nonqualified stock options and restricted stock awards. The exercise price for incentive stock options must be at least equal to the fair valueterms of the common stock on the grant date. Unless otherwise stated in a stock option agreement, 25% of the shares subject to an option grant will vest upon the first anniversary of the vesting start date and thereafter at the rate of one forty-eighth of the option shares per month as of the first day of each month after the first anniversary. Upon termination of employment by reasons other than death, cause, or disability, any vested options shall terminate 60 days after the termination date. Stock options terminate 10 years from the date of grant. The 2003 Plan expired on May 21, 2013.2022 Sales Agreement.

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~~A summary of the Company’s stock option activity under the 2003 Plan for the nine months ended September 30, 2017 is as follows:~~

Weighted-Average

Remaining

Aggregate

Outstanding

Weighted-Average

Contractual Term

Intrinsic Value


Options

Exercise Price

(Years)

(In thousands)

Outstanding as of December 31, 2016

729,819

$
1.26

3.2

Options exercised

(16,608)

1.65

Options forfeited

—

—

Outstanding as of September 30, 2017

713,211

1.25

2.4

$
9,089

Vested as of September 30, 2017

713,211

1.25

2.4

$
9,089

Exercisable as of September 30, 2017

713,211

1.25

2.4

$
9,089

As of September 30, 2017, the options under the 2003 Plan were fully expensed. Total intrinsic value of the options exercised during the nine months ended September 30, 2017 and 2016 was $103,638 and $95,221, respectively, and total cash received for options exercised was $27,358 and $40,668 during the nine months ended September 30, 2017 and 2016, respectively. The total fair value of shares underlying options which vested in the nine months ended September 30, 2017 and 2016 was $1,573 and $14,450, respectively.

2013 Equity Incentive Plan

The Company’s board of directors adopted, and its stockholders approved, its 2013 Equity Incentive Plan (the 2013 Plan) effective on January 9, 2014. In April 2022, the Company’s board of directors approved an amendment and restatement of the 2013 Plan, which was approved by the Company’s stockholders at the Company’s annual meeting of stockholders held in May 2022 (as so amended, the Amended 2013 Plan).

The Amended 2013 Plan provides for the grant of incentive stock options within the meaning of Section 422 of the Internal Revenue Code to the Company’s employees and its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock awards, ~~restricted stock unit~~RSU awards, stock appreciation rights, performance stock awards and other forms of stock compensation to its employees, including officers, consultants and directors. The Amended 2013 Plan also provides for the grant of performance cash awards to the Company’s employees, consultants and directors. Unless otherwise stated in a stock option agreement, 25% of the shares subject to an option grant will typically vest upon the first anniversary of the vesting start date, ~~and thereafter at~~with the ~~rate of one forty-eighth~~balance of the ~~option~~ shares ~~per month~~vesting in a series of thirty-six successive equal monthly installments as of the first day of each month ~~after~~measured from the first ~~anniversary.~~anniversary of the vesting start date. Upon termination of employment by reasons other than death, cause, or disability, any vested options will terminate 90 days after the termination date, unless otherwise set forth in a stock option agreement. Stock options generally terminate 10 years from the date of grant.

Authorized Shares

The maximum number of shares of common stock that initially could be issued under the 2013 Plan was 1,000,000 shares, plus any shares subject to stock options or similar awards granted under the Company’s prior 2003 Equity Incentive Plan that ~~expire~~expired or ~~terminate~~terminated without having been exercised in full or ~~are~~were forfeited to or repurchased by the Company. The number of shares of common stock reserved for issuance under the 2013 Plan automatically ~~increases~~increased on January 1 of each year, ~~until~~through January 1, ~~2023,~~2022, by 3% of the total number of shares of common stock

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outstanding on December 31 of the preceding calendar ~~year,~~year. As of March 31, 2022, the total number of shares reserved for issuance under the 2013 Plan was 9,506,767 shares, of which 1,345,998 shares were available for future grants.

Following the approval of the Amended 2013 Plan by the Company’s stockholders, the share reserve under the Amended 2013 Plan was increased by 2,619,622 shares, and beginning on January 1, 2023 and ending on (and including) January 1, 2029, the maximum number of shares of common stock that may be issued under the Amended 2013 Plan will cumulatively be increased by 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or asuch lesser number of shares as ~~may be~~ determined by the ~~Company’s~~ board of ~~directors.~~ directors or the compensation committee thereof.The maximum number of shares that may be issued pursuant to exercise of incentive stock options under the Amended 2013 Plan is 20,000,000 shares. As of ~~January 1, 2017, the number of shares of common stock that may be issued under the 2013 Plan was automatically increased by 697,500 shares, representing 3% of~~March 31, 2023, the total number of shares ~~of common stock outstanding on December 31, 2016, increasing the number of shares of common stock available~~reserved for issuance under the Amended 2013 Plan ~~to 2,837,201 shares.~~was 11,681,878 shares, of which 2,206,376 shares were available for future grants.

Shares issued under the Amended 2013 Plan may be authorized but unissued or reacquired shares of common stock. Shares subject to stock awards granted under the Amended 2013 Plan that expire or terminate without being exercised in full, or that are paid out in cash rather than in shares, will not reduce the number of shares available for issuance under the Amended 2013 Plan. Additionally, shares issued pursuant to stock awards under the Amended 2013 Plan that the Company repurchases or that are forfeited, as well as shares reacquired by the Company as consideration for the exercise or purchase price of a stock

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award or to satisfy tax withholding obligations related to a stock award, will become available for future grant under the Amended 2013 Plan.

A summary of the Company’s stock option activity under the Amended 2013 Plan for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2023 is as follows:

Weighted-Average

Remaining

Aggregate

Outstanding

Weighted-Average

Contractual Term

Intrinsic Value

Options

Exercise Price

(Years)

(In thousands)

Outstanding as of December 31, 2016

2,066,105

$
7.41

7.9

Options granted

674,738

7.03

Options exercised

(32,521)

5.96

Options forfeited

(22,159)

7.35

Outstanding as of September 30, 2017

2,686,163

7.33

7.6

$
17,884

Vested or expected to vest as of September 30, 2017

2,686,163

7.33

7.6

$
17,884

Exercisable as of September 30, 2017

1,453,937

7.84

6.7

$
9,003


				WEIGHTED-	AGGREGATE
		WEIGHTED-		AVERAGE	INTRINSIC
		AVERAGE		REMAINING	VALUE
	OUTSTANDING	EXERCISE		CONTRACTUAL	(IN
	OPTIONS	PRICE		TERM (YEARS)	THOUSANDS)
Outstanding as of December 31, 2022	6,774,792	$	6.37	4.7
Options granted	2,206,050		2.61
Options exercised	(16,800)		2.01
Options forfeited	(246,131)		2.25
Outstanding as of March 31, 2023	8,717,911		5.54	6.6	$	336
Vested or expected to vest as of March 31, 2023	8,576,011		5.62	6.5		315
Exercisable as of March 31, 2023	4,928,465		8.05	4.5		58

The weighted-average fair value of the options granted during the nine months ended September 30, 2017 and 2016 was $4.76 per share and $3.38 per share, respectively, applying the Black-Scholes-Merton option pricing model utilizing the following weighted-average assumptions:

Nine Months Ended

Nine Months Ended

September 30, 2017

September 30, 2016
Expected term

6.25 years

6.25 years
Expected volatility

75.20%

68.86%
Risk-free interest rate

2.08%

1.69%
Expected dividend yield

0%

0%

As of ~~September 30, 2017,~~March 31, 2023, there was ~~$4,854,266~~$6,064,322 of total unrecognized compensation expense related to unvested options under the Amended 2013 Plan that will be recognized over a weighted-average period of approximately ~~2.2~~3.2 years. Total intrinsic value of the options exercised during the ~~nine~~three months ended ~~September 30, 2017 and 2016~~March 31, 2023 was ~~$228,291 and $2,275, respectively,~~$23,760 and total cash received for options exercised was ~~$193,669 and $27,825~~$33,768. There were no options exercised under the Amended 2013 Plan during the ~~nine~~three months ended ~~September 30, 2017 and 2016, respectively.~~March 31, 2022. The total fair value of ~~shares underlying~~stock options which vested in the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022 was ~~$2,872,004~~$704,311 and ~~$2,364,683,~~$1,263,094, respectively.

~~A restricted~~In January 2022, the Company granted stock ~~unit (RSU)~~options to purchase an aggregate of 141,900 shares to certain employees under the 2013 Plan which were subject to performance vesting conditions. The shares will vest upon achievement of milestones as follows: (i) one-half of the shares will vest upon FDA approval of uproleselan for patients with relapsed/refractory acute myeloid leukemia and (ii) one-half of the shares will vest upon the first commercial sale of uproleselan in the United States or abroad. The maximum fair value of $113,520 associated with the performance-based options granted in January 2022 is excluded from the unrecognized compensation expense under the 2013 Plan as the completion of the performance milestones was not probable as of March 31, 2023. The Company will reevaluate at the end of each reporting period the probability that the performance conditions will be achieved and will record any adjustments to the compensation cost at that time.

An RSU is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant. In

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January 2021, the Company awarded RSUs under the 2013 Plan to all of its employees. The ~~Company has~~RSUs granted ~~RSUs with service conditions (service RSUs) that~~ vest over four years in ~~three~~ equal ~~annual~~ installments on each anniversary of the grant date, provided that the employee remains employed ~~with~~by the ~~Company.~~Company at the applicable vesting date. Compensation expense is recognized on a straight-line basis. As of ~~September 30, 2017,~~March 31, 2023, there was ~~$30,763~~$418,961 of total unrecognized compensation ~~costs related to unvested service RSUs.~~expense associated with outstanding RSU grants that will be recognized over a weighted-average period of approximately 1.8 years.

The following is a summary of RSU activity under the Amended 2013 Plan for the ~~nine~~three months ended ~~September 30, 2017:~~

Weighted-Average

Number

Grant Date

of Shares

Fair Value

Unvested at December 31, 2016

16,916

$
5.04

Granted

—

—

Forfeited

—

—

Vested

4,833

4.61

Unvested at September 30, 2017

12,083

5.21

March 31, 2023:


		Weighted-Average
	Number of Shares	Grant Date
	Underlying RSUs	Fair Value
Unvested at December 31, 2022	204,785	$	3.81
Forfeited	(15,030)		3.81
Vested	(68,054)		3.81
Unvested at March 31, 2023	121,701		3.81

Inducement Plan

The Company’s board of directors previously adopted the GlycoMimetics, Inc. Inducement Plan (as amended to date, the Inducement Plan). The Inducement Plan provides for the grant of nonstatutory stock options, restricted stock awards, RSU awards, stock appreciation rights and other forms of stock awards to individuals not previously an employee or director of the Company as an inducement for such individuals to join the Company. Unless otherwise stated in an applicable stock option agreement, one-fourth of the shares subject to an option grant under the Inducement Plan will typically vest upon the first anniversary of the vesting start date, with the balance of the shares vesting in a series of thirty-six successive equal monthly installments as of the first day of each month measured from the first anniversary of the vesting start date, subject to the new employee’s continued service with the Company through the applicable vesting dates. Upon termination of employment by reasons other than death, cause or disability, any vested options will terminate 90 days after the termination date, unless otherwise set forth in a stock option agreement. Stock options generally terminate 10 years from the date of grant. The Inducement Plan was amended by the board of directors on multiple occasions to increase the number of shares reserved for issuance to 3,000,000 shares as of March 31, 2023. As of March 31, 2023, there were 409,508 shares available for future grants under the Inducement Plan.

A summary of the Company’s stock option activity under the Inducement Plan for the three months ended March 31, 2023 is as follows:


				WEIGHTED-	AGGREGATE
		WEIGHTED-		AVERAGE	INTRINSIC
		AVERAGE		REMAINING	VALUE
	OUTSTANDING	EXERCISE		CONTRACTUAL	(IN
	OPTIONS	PRICE		TERM (YEARS)	THOUSANDS)
Outstanding as of December 31, 2022	2,333,525	$	1.82	8.5
Options granted	250,000		3.25
Options forfeited	(3,125)		3.58
Outstanding as of March 31, 2023	2,580,400		1.95	7.7	$	149
Vested or expected to vest as of March 31, 2023	1,996,200		1.95	7.5		142
Exercisable as of March 31, 2023	579,033		1.98	8.4		10

As of March 31, 2023, there was $1,935,838 of total unrecognized compensation expense related to unvested options under the Inducement Plan that will be recognized over a weighted-average period of approximately 2.9 years. The total fair value of stock options which vested in the three months ended March 31, 2023 and 2022 was $181,032 and $10,667, respectively. There were no options exercised under the Inducement Plan during the three months ended March 31, 2023 and 2022.

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During the years ended December 31, 2022 and 2021, the Company granted stock options to purchase an aggregate of 584,200 shares to certain newly hired employees under the Inducement Plan which options were subject to the same performance vesting conditions described above with respect to the stock options granted in January 2022 under the 2013 Plan. The maximum fair value of $825,353 associated with the performance-based options is excluded from the unrecognized compensation expense under the Inducement Plan as the completion of the performance milestones were not probable as of March 31, 2023. The Company will reevaluate at the end of each reporting period the probability that the performance conditions will be achieved and will record any adjustments to the compensation cost at that time.

The weighted-average fair value of the options granted under all equity incentive plans during the three months ended March 31, 2023 and 2022 was $2.04 per share and $0.80 per share, respectively, applying the Black-Scholes-Merton option pricing model utilizing the following weighted-average assumptions:


	Three Months Ended March 31,
	2023	2022
Expected term	6.25 years	6.25 years
Expected volatility	79.56%	84.51%
Risk-free interest rate	3.52%	1.66%
Expected dividend yield	0%	0%

Stock-based compensation expense was classified on the ~~statement~~statements of operations as follows for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016:~~

Three Months Ended September 30,

Nine Months Ended September 30,


2017

2016

2017

2016

Research and development expense

$
327,133

$
260,882

$
953,821

$
772,163

General and administrative expense

635,212

478,531

1,842,480

1,466,484

Total stock-based compensation expense

$
962,345

$
739,413

$
2,796,301

$
2,238,647

2022:


	Three Months Ended March 31,
	2023		2022
Research and development expense	$	237,931	$	318,825
General and administrative expense		632,249		761,817
Total stock-based compensation expense	$	870,180	$	1,080,642

8. Income Taxes

The Company ~~has~~did not ~~recorded~~record any tax provision or benefit for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2023 and ~~2016.~~2022. The Company has provided a valuation allowance for the full amount of its net deferred tax assets since realization of any future benefit from deductible temporary differences, net operating loss carryforwards and research and development credits is not more-likely-than-not to be realized at ~~September 30, 2017~~March 31, 2023 and December 31, ~~2016.~~2022.

9. License and Collaboration Agreements

~~9. Research and License Agreements~~

Apollomics

In ~~October 2011,~~2020, the Company entered into a collaboration and license agreement (the Agreement) with Apollomics (Hong Kong), Limited (Apollomics) for the development, manufacture and commercialization of products derived from two of the Company’s compounds, GMI-1271 and GMI-1687 (the Products) for therapeutic and prophylactic uses (the Field) in China, Taiwan, Hong Kong and Macau (the Territory). Under the terms of the Agreement, the Company granted Apollomics:

●

an exclusive license, with the right to sublicense, to develop, manufacture and have manufactured, distribute, market, promote, sell, have sold, offer for sale, import, label, package and otherwise the Products in the Field in the Territory; and

●

a non-exclusive license to conduct preclinical research with respect to Products in the Field outside of the Territory for the purposes of developing such Products for use in the Territory.

In 2020, the Company and ~~Pfizer~~Apollomics also entered into ~~the Pfizer Agreement that provides Pfizer an exclusive worldwide license~~a clinical supply agreement pursuant to ~~rivipansel for vaso-occlusive crisis associated with sickle cell disease and for other diseases for~~ which the ~~drug candidate may be developed.~~Company will manufacture and supply the Products at agreed upon prices. Apollomics has the option to begin

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manufacture of the Products after appropriate material transfer requirements are met. The Company ~~was responsible for completion~~did not recognize revenue under the clinical supplies agreement during the three months ended March 31, 2023 and 2022.

The Company evaluated the Agreement under the provisions of ASC 606 and identified two performance obligations under this revenue arrangement: the (i) delivery of functional licenses and (ii) manufacture and supply of the ~~Phase 2~~Products. The initial transaction price consists of a $9.0 million non-refundable up-front payment which was allocated to the delivered functional licenses and recognized in full as revenue in 2020 given that the performance obligation was satisfied upon inception. The Agreement contains various forms of variable consideration, including (i) up to $75.0 million in development milestones based on achievement of certain clinical ~~trial, after which Pfizer assumed all further~~and regulatory events, (ii) up to $105.0 million of sales-based commercial milestones based on achievement of certain annual net sales targets, (iii) sales-based royalties at specified percentages of net sales ranging from the high single digits to 15%, and (iv) manufacture and supply of clinical and commercial Products. The Company has fully constrained the development milestone consideration using the most likely amount method and ~~commercialization responsibilities. Upon execution~~will recognize that revenue when it is probable that recognition of revenue related to the ~~Pfizer Agreement,~~milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. In 2020, the Company received ~~an up-front~~a non-refundable $1.0 million development milestone payment upon acceptance by Chinese regulatory authorities of $22.5 million. The Pfizer Agreement also provides for potential milestone payments of up to $115.0 million upon the achievement of specified development milestones, including the dosing of the first patients ina Phase 3 ~~clinical trials for up~~bridging study design to ~~two indications~~support registration in China and ~~the first commercial sale of a licensed product in the United States and selected European countries for up to two indications; potential milestone payments of up to $70.0~~recognized this $1.0 million upon the achievement of specified regulatory milestones, including the acceptance of our filings for regulatory approval by regulatory authorities in the United States and Europe for up to two indications; and potential milestone payments of up to $135.0 million upon the achievement of specified levels of annual net sales of licensed products. Pfizer has the right to terminate the Pfizer Agreement by giving prior written notice.

The Company has determined that each potential future clinical, development and regulatory milestone is substantive. Although sales-based milestones are not considered substantive, they are still recognized upon achievement of the milestone (assuming all otherpayment as revenue ~~recognition criteria have been met) because there are no undelivered elements that would preclude revenue recognition~~ at that time. The Company is also eligible to receive royalties on future sales contingent upon annual net sales thresholds. In addition, the Company and Pfizer have formed a joint steering committee that will oversee and coordinate activities as set forth in the research program. The $22.5 million up-front payment was recognized over a period of 1.5 years. In May 2014, Pfizer made a $15.0 million non-refundable milestone payment to the Company, which was recognized as revenue by the Company in May 2014 when earned. In June 2015, Pfizer dosed the first patient in the Phase 3 clinical trial of rivipansel, which triggered a non-refundable milestone payment to the Company of $20.0 million, which the Company recognized as revenue in June 2015. The Company did not recognize any milestone revenue under the ~~Pfizer~~ Agreement ~~during the three and nine months ended September 30, 2017 or 2016.~~

In February 2004, the Company entered into a research services agreement (the Research Agreement) with the University of Basel (the University) for biological evaluation of selectin antagonists. Certain patents covering the rivipansel compound are subject to provisions of the Research Agreement. Under the terms of the Research Agreement, the Company will owe to the University 10% of all future milestone and royalty payments received from Pfizer with respect to rivipansel. There were no milestone payments due to the University for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and 2022.

The Company will recognize revenue related to the sales-based commercial and royalty milestones and royalties at the later of (i) when the related sales occur or ~~2016.~~(ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied), as they were determined to relate predominantly to the licenses granted to Apollomics and, therefore, have been excluded from the transaction price. Lastly, the Company has determined that the consideration for the manufacturing and supply is all variable and is fully constrained. Variable consideration allocated to manufacturing and supply will be recognized at a point in time when the Product is delivered and when the title to the Product is transferred to the customer pursuant to the agreement. The Company reassesses the transaction price in each reporting period and upon the occurrence of a change in circumstances or final resolution of any particular event.

10. Subsequent Events

In April 2023, the Company and its landlord entered into an amendment to its Lease (see Note 6). Pursuant to the amendment, the Company and the landlord agreed that the term for the leased “9708 premises,” consisting of approximately 30,000 square feet, would be extended for the period from November 1, 2023 to January 31, 2025, with a three percent annual increase in base rent effective on November 1, 2023 and November 1, 2024. The amendment results in an additional $1.0 million in rent obligations. The Company’s lease of the “9712 premises,” consisting of approximately 12,000 square feet, will terminate on October 31, 2023.

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ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

~~ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS~~

Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q, our Annual Report on Form 10-K, particularly in Part I – Item 1A, “Risk Factors,” and our other filings with the Securities and Exchange Commission. Statements made herein are as of the date of the filing of this Form 10-Q with the Securities and Exchange Commission and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the year ended December 31, ~~2016,~~2022, which are included in our Annual Report on Form 10-K filed with the ~~Securities and Exchange Commission~~SEC on March ~~1, 2017.~~29, 2023.

Overview

We are a ~~clinical-stage~~late-stage clinical development biotechnology company focused on improving the ~~discovery~~lives of people living with cancer and ~~development~~inflammatory diseases by leveraging the inhibition of ~~novel glycomimetic drugs to address unmet medical needs resulting from diseases in~~carbohydrate interactions that occur on the surface of cells. We are developing a pipeline of proprietary glycomimetics, which ~~carbohydrate biology plays a key role. Glycomimetics~~ are small molecules that mimic the structure of carbohydrates involved in important biological processes. Our proprietary glycomimetics platform is based on our expertise in carbohydrate chemistry and our understanding of the role carbohydrates play in key biological processes. Using this expertise and understanding, we are developing a pipeline of proprietary glycomimetics designedprocesses, to inhibit disease-related functions of carbohydrates such as the roles they play in inflammation, cancer and infection. We believe this represents an innovative approach to drug discovery to treat a wide range of diseases. We are focusing our efforts on drug candidates for diseases that we believe will qualify for orphan drug designation.

Our proprietary glycomimetics platform is based on our expertise in carbohydrate chemistry and our understanding of the role carbohydrates play in key biological processes. Most human proteins are modified by the addition of complex ~~carbohydrates~~carbohydrate structures to the surface of ~~the proteins. The addition of these carbohydrate structures~~such proteins, which affects the functions of ~~these~~the proteins and their interactions with other molecules. Our initial research and development efforts have focused on drug candidates targeting selectins, which are proteins that serve as adhesion molecules and bind to carbohydrates that are involved in the inflammatory component and progression of a wide range of diseases, including hematologic disorders, cancer and cardiovascular disease. For example, we believe that members of the selectin family play a key role in tumor metastasis and resistance to chemotherapy. Inhibiting specific carbohydrates from binding to selectins has long been viewed as a potentially attractive approach for therapeutic intervention. The ability to successfully develop drug-like carbohydrate compounds that inhibit binding with selectins, known as selectin antagonists, has historically been limited by their potency and the complexities of carbohydrate chemistry. We believe our expertise in the rational design of potent glycomimetic antagonists with drug-like properties and in carbohydrate chemistry enables us to ~~design~~identify highly effective selectin antagonists and other glycomimetics that may inhibit the disease-related functions of certain ~~carbohydrates.~~

~~We are focusing our initial efforts on~~carbohydrates in order to develop novel drug candidates ~~for rare~~to address orphan diseases ~~that we believe will qualify for orphan drug designation.~~ with high unmet medical need.

Our first drug candidate, rivipansel, is a pan-selectin antagonist being developed for the treatment of vaso-occlusive crisis, or VOC, a debilitating and painful condition that occurs periodically throughout the life of a person with sickle cell disease. We have entered into an agreement with Pfizer Inc., or Pfizer, for the further development and potential commercialization of rivipansel worldwide. Rivipansel has received fast track designation from the U.S. Food and Drug Administration, or FDA, as well as orphan drug designation from the FDA in the United States and from the European Medicines Agency, or EMA, in the European Union. We believe the clinical progress of rivipansel provides evidence of the significant potential of our lead ~~program and our proprietary glycomimetics platform.~~

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~~Building on our experience with rivipansel, we are developing a pipeline of other glycomimetic drug candidates. Our second~~ glycomimetic drug candidate, ~~GMI-1271,~~uproleselan, is a specific E-selectin ~~inhibitor, which~~antagonist that we are developing to be used in combination with chemotherapy to treat patients with ~~either~~ acute myeloid leukemia, or AML, ~~or multiple myeloma, or MM, both of which are~~a life-threatening hematologic ~~cancers,~~cancer, and potentially other hematologic ~~cancers as well. We have~~cancers. In 2021, we completed enrollment of 388 patients in a randomized, double-blind, placebo-controlled Phase ~~1/2~~3 pivotal clinical trial to evaluate uproleselan in individuals with relapsed/refractory AML, the design of ~~GMI-1271~~which was based on guidance received from the U.S. Food and Drug Administration, or FDA. Pooled survival data show patients in the Phase 3 study continue to live longer than historically expected.

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In September 2022, we submitted a request to the FDA to amend the protocol for the trial to conduct an interim analysis and have the findings reviewed by the trial’s Independent Data Monitoring Committee, or IDMC, as ~~an adjunct~~blinded pooled survival data showed patients living longer than expected based on the historical benchmarks used to ~~standard chemotherapy in patients~~design the study. The statistical plan agreed to with ~~AML~~the FDA was for the IDMC to review efficacy and ~~are currently conducting~~safety data at 80% of survival events, which was reached at the end of 2022. When designing the interim analysis, we amended the protocol to create the opportunity to achieve unblinding at approximately 80% of survival events while maintaining the statistical integrity of the final analysis should the DMC recommend the study continue to the final overall events trigger. The interim analysis plan required a high statistical threshold to be met for the IDMC to recommend unblinding, reserving approximately 95% of the study’s statistical power for the final analysis.

In February 2023,the IDMC reviewed the interim utility analysis and recommended that the pivotal Phase 13 clinical trial continue to the originally planned final overall survival events trigger. Based on current projections, we anticipate reaching the overall survival events trigger within the first half of ~~GMI-1271 combined~~2024, with ~~chemotherapy~~top line data disclosure soon thereafter. As we continue the trial during 2023, we will continue our preparation for ~~the treatment~~a potential filing of ~~MM. In the Phase 2 portion of our AML clinical trial, AML patients treated~~an NDA with GMI-1271, combined with chemotherapy, have experienced higher-than-expected remission rates and lower-than-expected induction-related mortality rates. We believe the data generated in this Phase 1/2 clinical trial support conducting one or more additional clinical trials of GMI-1271 in AML, with the ultimate goal of obtaining marketing approval from the FDA.

~~GMI-1271 received orphan drug designation from~~We have also entered into a Cooperative Research and Development Agreement, or CRADA, with the ~~FDA in May 2015 for~~National Cancer Institute, or NCI, part of the ~~treatment~~National Institutes of ~~AML. In June 2016, GMI-1271 received fast track designation from~~Health, to conduct a Phase 2/3 randomized, controlled clinical trial testing the ~~FDA for the treatment~~addition of adult patients with relapsed or refractory AML and elderly patients aged 60 years or older with AML. In May 2017, GMI-1271 received Breakthrough Therapy designation from the FDA for the treatment of adult patients with relapsed or refractory AML. In May 2017, the European Commission, based onuproleselan to a ~~favorable recommendation from the EMA Committee for Orphan Medicinal Products, granted orphan designation for GMI-1271 for the treatment of AML.~~

~~In May 2015, we commenced our multinational, Phase 1/2, open-label trial of GMI-1271 as an adjunct to~~ standard chemotherapy ~~in patients with AML. This trial in males and females with AML enrolled patients at a number~~regimen. Enrollment of academic institutions in the United States, Ireland and Australia. The trial consists of two parts. In the Phase 1 portion, escalation testing was performed to determine a recommended GMI-1271 dose in combination with standard chemotherapy to be used in the Phase 2 portion. In the Phase 2 portion of the trial, dose expansion was performed at the recommended dose of 10 mg/kg GMI-1271 in combination with standard chemotherapy. The primary objective of the trial was to evaluate the safety of GMI-1271 in combination with chemotherapy. Secondary objectives were to characterize pharmacokinetics, or PK, pharmacodynamics, or PD, and to observe anti-leukemic activity. There were a total of 19 patients with relapsed or refractory AML enrolled and dosed with a single cycle of treatment with GMI-1271 and chemotherapy in the Phase 1 portion of the trial.

In the Phase 2 portion, one cohort of 25 patients over 60 years of age with newly diagnosed AML and a second cohort comprised of 47 patients with relapsed or refractory AML were enrolled. Unlike in the Phase 1 portion, some of the267 patients in the Phase 2 portion ~~were treated with multiple cycles of GMI-1271. In May 2017, we~~was completed ~~enrollment of 91 patients~~ in December 2021. There will be a planned interim analysis that will evaluate event-free survival and whether the ~~Phase 1/2 trial. We plan~~pre-specified threshold for continuing to ~~provide additional updates from this clinical trial in the fourth quarter of 2017 and in 2018. We are consulting with the FDA regarding the design of a potential~~ Phase 3 ~~pivotal~~has been met. The trial ~~that could~~may also provide support ~~an application~~ for ~~marketing approval for GMI-1271 for~~regulatory filings, if the ~~treatment of AML. Based on the feedback from the FDA, we plan to initiate this pivotal trial in mid-2018.~~

~~In June 2017, we presented new data from the Phase 2 portion~~results of the ~~trial~~planned interim analysis are sufficiently positive.

Uproleselan is also being studied in multiple investigator-sponsored trials. The initial results from two investigator-sponsored trials evaluating safety and preliminary efficacy in frontline unfit and treated secondary AML populations not previously studied with uproleselan were selected for poster presentation at the June 2017 annual meetings of the American Society of Clinical Oncology, or ASCO, and the European Hematology Association, or EHA. In the relapsed or refractory disease arm of the trial, 66 patients had been enrolled. Of the 54 relapsed/refractory patients with AML for whom data is available, the CR/CRi rate was 41%. The CR/CRi rate is the percentage of patients who achieved remission, with either full or incomplete blood count recovery. The mortality rate among this group at 60 days was 7%. Median overall survival of the 19 patients enrolled in the Phase 1 portion of the trial was 7.6 months. We believe these results compare favorably to what would be expected in this population, based on published historical controls in similar patients. In the newly-diagnosed, treatment-naïve elderly arm of the trial, 25 patients had been enrolled. Among these 25 patients, the CR/CRi rate was 68%, with a 73% rate for patients with de novo disease and 64% for patients with secondary AML.

~~Our data from the GMI-1271 program has been selected for two oral presentations at the upcoming annual meeting of the~~64^th American Society of Hematology ~~or ASH, to be~~Annual Meeting held in December ~~2017. One~~2022.

We have rationally designed an innovative antagonist of ~~these presentations will~~E-selectin, GMI-1687, that could be ~~an update on the current data set from the Phase 1/2 open-label trial of GMI-1271~~a subcutaneously administered treatment. Initially developed as ~~an adjunct~~a potential life-cycle extension to standard chemotherapy in patients with AML. The second oral presentation will present data from preclinical studies in which E-selectin was upregulated in a model of AML and increased resistance to chemotherapy, whichuproleselan, we believe ~~can~~that GMI-1687 could be ~~reversed by~~developed to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment ~~with GMI-1271.~~

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is preferred or required. In ~~December 2015, at the ASH annual meeting,~~May 2022, we ~~presented preclinical data suggesting that GMI-1271 could reverse resistance of certain chemotherapies seen~~filed an investigational new drug application, or IND, for GMI-1687 in MM. In September 2016, we dosed the first patient in a Phase 1 multiple dose-escalation clinical trial in defined populations of patients with MM who have not responded optimally to standard chemotherapy. In this trial, we are evaluating the efficacy, safety and PK of GMI-1271, combined with bortezomib- or carfilzomib-based chemotherapy, for the treatment of MM. We are currently enrolling patients at clinical trial sites in Ireland and have initiated the enrollment process at additional sites in Europe.

In addition to GMI-1271, we have designed a family of small molecule drug candidates that simultaneously inhibit both E-selectin and CXCR4. We have selected one of these compounds, GMI-1359, for development as a potential treatment for ~~certain malignancies. Since E-selectin~~vaso-occlusive crisis, or VOC, a common complication of sickle cell disease and ~~CXCR4~~received the “safe to proceed” letter from the FDA in June 2022.

We are ~~both adhesion molecules~~advancing other preclinical-stage programs, including small-molecule glycomimetic compounds that ~~keep cancer cells in~~inhibit the ~~bone marrow,~~protein galectin-3, which we believe may have potential to be an orally administered treatment for fibrosis, cancer and cardiovascular disease. In March 2022, we selected a lead galectin drug candidate, GMI-2093, for evaluation in preclinical studies. We are evaluating options for the further development of GMI-2093 as a potential treatment for fibrosis and in oncology indications.

We have also designed GMI-1359, a drug candidate that ~~targeting~~simultaneously targets both E-selectin and ~~CXCR4 with~~ a ~~single compound could improve efficacy in~~chemokine receptor known as CXCR4. In the ~~treatment~~fourth quarter of ~~cancers that affect the bone marrow such as AML and MM, as compared to targeting CXCR4 alone. In December 2016 at the ASH annual meeting,~~2021, we presented preclinical data suggesting that GMI-1359 has a unique tumor cell mobilization kinetic profile and enhanced the ability of chemotherapy to target and improve survival from a high-risk form of mutated AML.

~~In 2016, we completed enrollment in~~terminated a Phase ~~1 single-dose escalation~~1b trial of GMI-1359 in ~~healthy volunteers. In this trial, volunteer participants received a single injection~~hormone receptor positive breast cancer patients whose tumors had spread to bone and have deactivated the existing GMI-1359 INDs as of GMI-1359, after which they were evaluated for safety, tolerability, PK and PD. The randomized, double-blind, placebo-controlled, escalating dose study was conducted at a single site in the United States.August 2022. We are not currently ~~expanding enrollment in this trial with two additional cohorts and anticipate selecting an initial cancer indication for~~developing GMI-1359, but are seeking a licensing partner to continue clinical development of this drug ~~candidate and determining an optimal dose for further clinical evaluation in 2018.~~

Using our glycomimetics platform, we have also designed inhibitors that specifically block the binding of galectin-3 to carbohydrate structures. Galectin-3 is a protein that is known to play critical roles in many pathological processes, including fibrosis, inflammation, cancer and cardiovascular disease. We plan to optimize these compounds and conduct preclinical experiments in the fourth quarter of 2017 and in 2018 to further characterize the effects of galectin-3 inhibitors on immune processes and anti-fibrotic activity. We are also designing other galectin inhibitors that we believe could be used to treat various diseases.candidate.

We commenced operations in 2003, and our operations to date have been limited to organizing and staffing our company, business planning, raising capital, developing our glycomimetics platform, identifying potential drug candidates, undertaking preclinical studies and conducting clinical trials of rivipansel, GMI-1271 and GMI-1359. To date, we have financed our operations primarily through private placements of our securities, ~~upfront~~up-front and milestone payments under our license and collaboration ~~with Pfizer~~agreements and the net proceeds from ~~our IPO in January 2014,~~public offerings of common stock, including sales of common stock under at-the-market sales facilities with Cowen and Company LLC, or ~~Cowen, and our public offerings of common stock in June 2016 and May 2017.~~Cowen. We have no approved drugs currently available for sale, and substantially all of our revenue to date has been revenue from ~~the upfront~~up-front and milestone payments ~~from Pfizer, although we have received nominal amounts of revenue~~ under ~~research grants.~~license and collaboration agreements.

Prior to our IPO, we raised an aggregate of $86.6 million to fund our operations, of which $22.5 million was an upfront payment under our collaboration with Pfizer and $64.1 million was from the sale of our convertible promissory notes and convertible preferred stock. The IPO provided us with net proceeds of $57.2 million, and we received a non-refundable milestone payment from Pfizer in May 2014 of $15.0 million. In August 2015, we received another non-refundable milestone payment from Pfizer of $20.0 million following the dosing of the first patient in the Phase 3 clinical trial of rivipansel. We received an additional $19.7 million in net proceeds from our public offering in June 2016 and $86.8 million in net proceeds from our public offering in May 2017. In 2016 and to date in 2017 we have received an aggregate of $30.5 million of net proceeds under the at-the-market facilities with Cowen.

Since inception, we have incurred significant operating losses. We have generated cumulative revenue of $58.6 million since our inception through September 30, 2017, primarily consisting of the $22.5 million upfront payment from Pfizer in 2011, the $15.0 million non-refundable milestone payment in May 2014 and the $20.0 million non-refundable milestone payment in August 2015. We had an accumulated deficit of ~~$135.1~~$429.9 million as of ~~September 30, 2017,~~March 31, 2023 and we expect to continue to incur significant expenses and operating losses over at least the next

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several years. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials ~~the~~

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~~receipt of milestone payments, if any, under our collaboration with Pfizer,~~ and our expenditures on other research and development activities. We anticipate that our expenses will increase ~~substantially~~ as we:

●

initiate, conduct and ~~conduct~~complete our ongoing and planned clinical trials of ~~GMI-1271~~uproleselan, including fulfilling our funding and ~~GMI-1359;~~

supply commitments related to the ongoing clinical trials of uproleselan;

●

~~continue the research~~conduct NDA-enabling activities related to manufacture, toxicology and ~~development of~~clinical pharmacology for our ~~other drug~~product candidates;

●

~~seek to discover~~manufacture additional uproleselan drug supplies for validation and ~~develop additional drug candidates;~~

prepare for commercialization;

●

seek regulatory approvals for uproleselan or any other drug candidates ~~other than rivipansel~~ that successfully complete clinical trials;

●

ultimately establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize uproleselan or any other drug candidates ~~other than rivipansel~~ for which we may obtain regulatory approval;

●

maintain, expand and protect our intellectual property portfolio;

●

~~hire additional clinical, quality control~~maintain sufficient levels of insurance, including product liability and ~~scientific personnel;~~directors, officers and

corporate liability insurance policies; and

●

add ~~operational, financial and management information systems and personnel, including~~ personnel to support our drug development and potential future commercialization efforts.

To fund further operations, we will need to raise capital. We may obtain additional financing in the future through the issuance of our common stock, through other equity or debt financings, orpotentially including the use of our at-the-market sales facility with Cowen, through collaborations or partnerships with other ~~companies.~~companies or through the sale of potential royalty streams from a drug candidate. We may not be able to raise additional capital on terms acceptable to us, or at all, and any failure to raise capital as and when needed could compromise our ability to execute on our business plan. Although it is difficult to predict future liquidity requirements, we believe that our existing cash and cash equivalents ~~together with interest thereon,~~ will be sufficient to fund our operations ~~at least through~~into late fourth quarter of 2024 without giving effect to potential business development opportunities, such as upfront or milestone payments under license and collaboration agreements, or additional financing activities including the ~~second half~~potential sale of ~~2019.~~common stock under our at-the-market sales facility or otherwise. However, our ability to successfully transition to profitability will be dependent upon achieving a level of revenues adequate to support our cost structure. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

Impact of COVID-19 on Our Business

We continue to monitor developments associated with the COVID-19 pandemic. To date, we have experienced only minor disruptions from the pandemic, including a brief delay in patient enrollment in our Phase 3 clinical trial of uproleselan which subsequently completed enrollment in November 2021. The safety, health and well-being of all patients, medical staff and our internal and external teams is paramount and is our primary focus. As the pandemic evolves, we are aware that the potential exists for further disruptions to our projected timelines. We are in close communication with our clinical and manufacturing teams and key vendors and are prepared to take action should the pandemic worsen and impact our business in the future. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. We do not yet know the full extent of any impacts the pandemic may have on our business, operations, financial position and our clinical and regulatory activities.

Our Collaboration ~~with Pfizer~~and License Agreements

Apollomics

In ~~October 2011,~~2020, we entered into ~~the~~an exclusive collaboration and license agreement with ~~Pfizer under which we granted Pfizer an exclusive worldwide license to develop~~Apollomics (Hong Kong) Limited, or Apollomics, for the development and ~~commercialize products containing rivipansel for all fields~~commercialization of uproleselan and ~~uses. The license~~GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also covers specified back-up compounds along with modifications of and improvements to rivipansel that meet defined chemical properties. Pfizer is required to use commercially reasonable efforts, at its expense, to develop, obtain regulatory approval for and commercialize rivipansel for sickle cell disease in the United States.known as Greater China. Under the terms of the agreement, weApollomics will be responsible for clinical development and commercialization in Greater China. We will also collaborate with Apollomics

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to advance the preclinical and clinical development of GMI-1687. We received an upfront cash payment of $9.0 million and in 2020 also received a ~~$22.5~~$1.0 million ~~upfront~~development milestone payment. ~~We are also eligible to earn potential~~There were no milestone payments ~~of up~~from Apollomics during the quarters ended March 31, 2023 or 2022. Subject to ~~$115.0 million upon~~ the ~~achievement of specified development milestones, including the dosing~~terms of the first patients in Phase 3 clinical trials for up to two indications and the first commercial sale of a licensed product in the United States and selected European countries for up to two indications, up to $70.0 million upon the achievement of specified regulatory milestones, including the acceptance of our filings for regulatory approval by regulatory authorities in the United States and Europe for up to two indications, and up to $135.0 million upon the achievement of specified levels of annual net sales of licensed products. We are alsoagreement, we will be eligible to receive potential further milestone payments totaling approximately $179.0 million, as well as tiered royalties ~~for each licensed product, with percentages~~ ranging from the ~~low double~~high single digits to 15%, as a percentage of net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for uproleselan and GMI-1687 in Greater China, and we and Apollomics expect to enter into clinical and commercial supply agreements with respect to our provision of uproleselan and GMI-1687 to Apollomics. We retain all rights for both compounds in the ~~low teens, based on net sales worldwide, subject to reductions in specified circumstances.~~rest of the world.

~~The first potential milestone payment under~~In 2020, the ~~Pfizer agreement was $35.0 million upon~~China National Medical Products Administration, or NMPA, Center for Drug Evaluation, or CDE, granted IND approval for uproleselan (also known as APL-106), enabling the initiation of ~~dosing~~a Phase 1 pharmacokinetics and tolerability study and a planned Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory AML. In 2021, APL-106 was granted Breakthrough Therapy Designation from the China NMPA CDE for the treatment of relapsed/refractory AML. In 2021, Apollomics enrolled the first patient in athe Phase 3 clinical trial of rivipansel by Pfizer. Under the collaboration, Pfizer made a $15.0 million non-refundable milestone payment to us in May 2014, which we recognized as revenue in May 2014, when earned,1 study and ~~the dosing of~~enrolled the first patient in the Phase 3 ~~clinical~~portion of the trial later in June 2015 triggered the remaining $20.0 million milestone payment to us. We recorded the $20.0 million milestone payment as revenue in June 2015. There were no milestone payments received from Pfizer for the three or nine months ended September 30, 2017.2021.

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WeIn 2020, we also entered into a ~~research services~~clinical supply agreement with the University of Basel, or the University, for biological evaluation of selectin antagonists. Certain patents covering the rivipansel compound are subject to provisions of the Research Agreement. Under the terms of the Research Agreement,Apollomics under which we will ~~owe~~manufacture and supply uproleselan product to Apollomics at agreed upon prices. Apollomics has the ~~University 10% of all future milestone and royalty payments received from Pfizer with respect~~option to ~~rivipansel. In February 2016, we paid $2.0 million to the University based upon the non-refundable milestone payments from Pfizer. We recorded these payments during~~begin manufacture after appropriate material transfer requirements are met. During the year ended December 31, ~~2015, at~~2021, we recognized $1.1 million in revenue from the ~~time~~sale of clinical supplies to Apollomics under the ~~payments became due to the University.~~clinical supply agreement. There were no ~~additional payments due~~sales of clinical supplies to Apollomics during the ~~University for the three months~~quarters ended March 31, 2023 or ~~nine months ended September 30, 2017.~~2022.

Critical Accounting Policies and Significant Judgments and Estimates

~~There~~Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been noprepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of revenue and expenses during the reporting periods. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances at the time such estimates are made. Actual results may materially differ from our estimates and judgments under different assumptions or conditions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material ~~changes~~revisions in estimates are reflected in our financial statements prospectively from the date of the change in estimate.

We define our critical accounting policies as those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments ~~during~~about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the ~~nine months ended September 30, 2017 compared to~~specific manner in which we apply those principles. For a description of our critical accounting policies and estimates, please see the disclosures in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, ~~2016.~~2022. There have not been any material changes to our critical accounting policies and estimates since December 31, 2022.

Components of Operating Results

Revenue

To date, we have not generated any revenue from the sale of our drug candidates and do not expect to generate any revenue from the sale of drugs in the near future. Substantially all of our historical revenue ~~recognized to date has~~ consisted of ~~the~~ upfront and milestone payments under ~~our agreement with Pfizer.~~license and collaboration agreements.

Since our inception, we have also recognized a nominal amount of revenue under research grant contracts, generally to the extent of our costs incurred in connection with specific research or development activities.

Research and Development

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, facilities expenses, overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, fees paid to ~~contract research organizations~~CROs and other consultants and other outside expenses. Other preclinical research and platform programs include

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activities related to exploratory efforts, target validation, lead optimization for our earlier programs and our proprietary glycomimetics platform.

~~To date, our~~ Our research and development expenses have related primarily to the development of ~~rivipansel~~uproleselan and our other drug candidates. ~~In April 2013, when we completed our Phase 2 clinical trial of rivipansel, all further clinical development obligations associated with rivipansel shifted to Pfizer.~~

We do not currently utilize a formal time allocation system to capture expenses on a project-by-project basis because we are organized and record expense by functional department and our employees may allocate time to more than one development project. Accordingly, we only allocate a portion of our research and development expenses by functional area and by drug candidate.

Research and development costs are expensed as incurred. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed.

Research and development activities are central to our business model. Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later stage clinical trials. We expect our research and development expenses to increase over the next several years as we seek to progress ~~GMI-1271, GMI-1359~~uproleselan, GMI-1687 and our other drug candidates into and through clinical development. ~~For example, as we prepare to potentially submit an application for marketing approval for GMI-1271, we will incur substantial expenses in scaling up the production and manufacturing of GMI-1271.~~ However, it is difficult to determine with certainty the duration and completion costs of our current or future preclinical studies and clinical trials of our drug candidates, or if, when or to what extent we will generate revenues from the commercialization

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and sale of any of our drug candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our drug candidates.

The duration, costs and timing of clinical trials and development of our drug candidates will depend on a variety of factors that include:

●

per patient trial costs;

●

the number of patients that participate in the trials;

●

the number of sites included in the trials;

●

the countries in which the trial is conducted;

●

the length of time required to enroll eligible patients;

●

the number of doses that patients receive;

●

the drop-out or discontinuation rates of patients;

●

potential additional safety monitoring or other studies requested by regulatory agencies;

●

the duration of patient follow-up; and

●

the safety and efficacy profile of the drug candidate.

In addition, the probability of success for each drug candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each drug candidate, as well as an assessment of each drug candidate’s commercial potential.

General and Administrative

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, business development and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, legal fees relating to patent and corporate matters and fees for accounting and consulting services. We anticipate that our general and administrative expenses will increase in the future ~~to support our continued research and development activities.~~as we undertake commercialization efforts for uproleselan.

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Interest Income

~~Other Income~~

~~Other~~Interest income consists of interest income earned on our cash and cash equivalents.

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Results of Operations for the Three ~~and Nine~~ Months Ended ~~September 30, 2017~~March 31, 2023 and ~~2016~~2022

The following ~~tables set~~table sets forth our results of ~~operations for the three and nine months ended September 30, 2017 and 2016:~~

Three Months Ended September 30,

Period-to-Period

(in thousands)

2017

2016

Change

Revenue

$
—

$
18

$
(18)

Costs and expenses:

Research and development expense

5,780

5,921

(141)

General and administrative expense

2,402

1,984

418

Total costs and expenses

8,182

7,905

277

Loss from operations

(8,182)

(7,887)

(295)

Other income

232

32

200

Net loss and comprehensive loss

$
(7,950)

$
(7,855)

$
(95)

Nine Months Ended September 30,

Period-to-Period

(in thousands)

2017

2016

Change

Revenue

$
—

$
18

$
(18)

Costs and expenses:

Research and development expense

17,380

17,221

159

General and administrative expense

7,016

6,352

664

Total costs and expenses

24,396

23,573

823

Loss from operations

(24,396)

(23,555)

(841)

Other income

373

74

299

Net loss and comprehensive loss

$
(24,023)

$
(23,481)

$
(542)

operations:


	Three Months Ended March 31,				Net Change
(dollars in thousands)	2023		2022
Costs and expenses:
Research and development expense	$	5,419	$	9,604	$	(4,185)	(44)	%
General and administrative expense		5,522		5,056		466	9	%
Total costs and expenses		10,941		14,660		(3,719)	(25)	%
Loss from operations		(10,941)		(14,660)		3,719	25	%
Interest income		582		7		575	8,214	%
Net loss and comprehensive loss	$	(10,359)	$	(14,653)	$	4,294	29	%

Research and Development Expense

The following ~~tables summarize~~table summarizes our research and development expense by functional area for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016:~~2022:



	Three Months Ended September 30,				Period-to-Period
(in thousands)	2017		2016		Change

							Three Months Ended March 31,				Net Change
(dollars in thousands)							2023		2022
Clinical development	$	1,109	$	2,389	$	(1,280)	$	1,376	$	3,016	$	(1,640)	(54)	%
Manufacturing and formulation		1,893		893		1,000		454		2,942		(2,488)	(85)	%
Contract research services, consulting and other costs		308		332		(24)		641		389		252	65	%
Laboratory costs		499		466		33		427		499		(72)	(14)	%
Personnel-related		1,644		1,580		64		2,283		2,439		(156)	(6)	%
Stock-based compensation		327		261		66		238		319		(81)	(25)	%
Research and development expense	$	5,780	$	5,921	$	(141)	$	5,419	$	9,604	$	(4,185)	(44)	%

Nine Months Ended September 30,

Period-to-Period

(in thousands)

2017

2016

Change

Clinical development

$
4,392

$
5,403

$
(1,011)

Manufacturing and formulation

4,165

3,780

385

Contract research services, consulting and other costs

1,196

1,354

(158)

Laboratory costs

1,456

1,237

219

Personnel-related

5,217

4,675

542

Stock-based compensation

954

772

182

Research and development expense

$
17,380

$
17,221

$
159

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During the three months ended September 30, 2017, our research and development expense decreased by $141,000, or 2%, compared to the same period in 2016. The decrease was primarily caused by lower clinical trial expenses related to the Phase 2 clinical trial of GMI-1271 for the treatment of AML due to patient enrollment completion in May 2017 and a decrease in costs for non-clinical toxicology studies and clinical studies for GMI-1359. These decreases were offset in part by additional costs related to the manufacturing of Phase 3 clinical supplies of GMI-1271. Personnel-related and stock-based compensation expenses increased due to annual salary adjustments for research and development personnel and annual stock option awards granted in the first quarter of 2017. During the nine months ended September 30, 2017, our research and development expense increased by $159,000, or 1%, compared to the same period in 2016. The increase was caused by the ongoing costs associated with the clinical trials for GMI-1271 in AML and MM, partially offset by a decrease in expenses related to non-clinical toxicology and clinical studies and manufacturing and process development for GMI-1359. Personnel-related and stock-based compensation expenses increased due to annual salary adjustments for research and development personnel and annual stock option awards granted in the first quarter of 2017.

The following ~~tables summarize~~table summarizes our research and development expense by drug candidate for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016:~~2022:



	Three Months Ended September 30,				Period-to-Period
(in thousands)	2017		2016		Change
GMI-1271	$	2,921	$	2,799	$	122
GMI-1359		253		715		(462)

							Three Months Ended March 31,				Net Change
(dollars in thousands)							2023		2022
Uproleselan							$	2,272	$	5,286	$	(3,014)	(57)	%
GMI-1687								35		812		(777)	(96)	%
Other research and development		635		565		70		591		748		(157)	(21)	%
Personnel-related and stock-based compensation		1,971		1,842		129		2,521		2,758		(237)	(9)	%
Research and development expense	$	5,780	$	5,921	$	(141)	$	5,419	$	9,604	$	(4,185)	(44)	%

Nine Months Ended September 30,

Period-to-Period

(in thousands)

2017

2016

Change

GMI-1271

$
8,760

$
7,619

$
1,141

GMI-1359

562

2,316

(1,754)

Other research and development

1,887

1,838

49

Personnel-related and stock-based compensation

6,171

5,448

723

Research and development expense

$
17,380

$
17,221

$
159

Our research and development expense for the three months ended March 31, 2023 decreased by $4.2 million compared to the same period ended March 31, 2022 primarily due to:

●

decreased clinical development costs related to uproleselan as patient enrollment ended in our Phase 3 clinical trial; and

●

decreased manufacturing and formulation costs related to uproleselan validation batches.

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General and Administrative Expense

The following ~~tables summarize~~table summarizes the components of our general and administrative expense for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2023 and ~~2016:~~2022:



	Three Months Ended September 30,				Period-to-Period
(in thousands)	2017		2016		Change

							Three Months Ended March 31,				Net Change
(dollars in thousands)							2023		2022
Personnel-related	$	729	$	640	$	89	$	2,151	$	1,994	$	157	8	%
Stock-based compensation		635		479		156		632		762		(130)	(17)	%
Legal, consulting and other professional expenses		863		719		144		2,453		2,105		348	17	%
Other		175		146		29		286		195		91	47	%
General and administrative expense	$	2,402	$	1,984	$	418	$	5,522	$	5,056	$	466	9	%

Nine Months Ended September 30,

Period-to-Period

(in thousands)

2017

2016

Change

Personnel-related

$
2,282

$
2,019

$
263

Stock-based compensation

1,842

1,467

375

Legal, consulting and other professional expenses

2,385

2,412

(27)

Other

507

454

53

General and administrative expense

$
7,016

$
6,352

$
664

23General and administrative expenses increased by $466,000 for the three months ended March 31, 2023 as compared to the same period in 2022. The increase was primarily due to higher personnel-related expenses as we continue to build our commercial operations with the hiring of a Vice President, Commercial Operations. In addition, our professional fees have increased with higher commercial readiness expenses for uproleselan and legal fees in the first quarter of 2023 as compared to 2022.

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Interest Income

During the three months ended ~~September 30, 2017, our general and administrative expense~~March 31, 2023 interest income increased by ~~$418,000~~$575,000 due to higher interest rates on invested balances in the first quarter of 2023 as compared to the same period in 2016, reflecting an increase of 21%. During the nine months ended September 30, 2017, our general and administrative expense increased by $664,000 compared to the same period in 2016, reflecting an increase of 10%. These increases in general and administrative expense were primarily attributable to annual salary adjustments awarded to general and administrative personnel and an increase in stock-based compensation expense caused by the 2017 awards to employees and directors.2022.

Liquidity and Capital Resources

Sources of Liquidity

We have historically financed our operations primarily through public offerings and private placements of our capital stock, ~~our IPO,~~including through our at-the-market sales ~~facilities~~facility with ~~Cowen, our public offerings in June 2016 and May 2017 and upfront and milestone payments from Pfizer.~~Cowen. As of ~~September 30, 2017,~~March 31, 2023, we had ~~$112.9~~$65.0 million in cash and cash equivalents.

We are potentially eligible to earn a significant amount of milestone payments and royalties under our agreement with Pfizer. Our ability to earn these payments and their timing is dependent upon the outcome of Pfizer’s activities and is uncertain at this time.

~~On March 1, 2016,~~In 2020, we entered into an at-the-market sales agreement, or the 2020 Sales Agreement, with Cowen ~~to sell shares of our common stock having an aggregate offering price of up to $40.0 million through Cowen acting as our sales agent. For the nine months ended September 30, 2017, we~~and sold an aggregate of ~~1,388,647~~4,117,363 shares of ~~our~~ common stock ~~under the at-the-market facility,~~through March 31, 2022 for net proceeds of ~~$7.4~~$14.4 million. ~~We and Cowen~~

In March 2022, we filed a shelf registration statement with the SEC, which was declared effective on April 22, 2022. On April 28, 2022, we terminated the ~~agreement in May 2017. As of its termination , we had sold an aggregate of 2,057,438 shares for net proceeds of $11.3 million under the at-the-market facility.~~

In May 2017, we completed a public offering in which we sold 8,050,000 shares of our common stock at a price to the public of $11.50 per share. We received net proceeds of $86.8 million from this offering, after deducting underwriting discounts, commissions2020 Sales Agreement and ~~other offering expenses.~~

~~On September 28, 2017, we~~ entered into a new at-the-market sales agreement, or the 2022 Sales Agreement, with ~~Cowen, under which~~Cowen. Under the 2022 Sales Agreement, we may ~~offer and~~ sell ~~from time~~up to ~~time at our sole discretion,~~$100.0 million in shares of our common ~~stock having an aggregate offering price of up to $100.0 million through Cowen acting as our sales agent. As of~~stock. During the ~~date of this report,~~year ended December 31, 2022, we ~~have~~ sold ~~an aggregate of 1,600,000~~1,953,854 shares of ~~our~~ common stock under the ~~new at-the-market facility,~~2022 Sales Agreement at a weighted average price of $2.22 per share, for aggregate net proceeds of ~~$19.2 million.~~$4.2 million, after deducting commissions and offering expenses. During the quarter ended March 31, 2023, we sold 9,822,930 shares of common stock under the 2022 Sales Agreement at a weighted average price of $3.01 per share, for aggregate net proceeds of $28.7 million, after deducting commissions and offering expenses. As of March 31, 2023, approximately $66.0 million remained available to be sold under the 2022 Sales Agreement.

We may also receive payments under our existing license and collaboration agreements. However, our ability to earn additional milestone payments and potential royalty payments and their timing will be dependent upon the outcome of our counterparties’ activities and is therefore uncertain at this time.

Funding Requirements

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, laboratory and related supplies, clinical costs, legal and other regulatory expenses and general overhead costs.

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As of March 31, 2023, our significant contractual obligations consisted solely of rent obligations under a non-cancelable lease for our current office space in Rockville, Maryland, which, as amended, has a term through January 2025. Our total remaining obligations under this lease as of March 31, 2023 were $652,000, which reflected the original lease termination date of October 31, 2023. Subsequent to March 31, 2023, we extended the term for the lease of a portion of the original premises, for which our additional rent obligations will be an aggregate of $1.0 million.

We have no other fixed long-term obligations and we do not have significant capital expenditure requirements.

We have also entered into various agreements for services with third-party vendors, including agreements to conduct clinical trials, to manufacture products, and for consulting and other contracted services. These agreements include cancellable terms and we accrue the costs of these agreements based on estimates of work completed to date.

The successful development of any of our drug candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of ~~GMI-1271~~uproleselan or our other drug candidates. We are also unable to predict when, if ever, material net cash inflows will commence from ~~rivipansel~~uproleselan or ~~GMI-1271.~~our other drug candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

●

successful enrollment in, and completion of, clinical trials;

●

receipt of marketing approvals from applicable regulatory authorities;

●

establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

●

obtaining and maintaining patent and trade secret protection and regulatory exclusivity for drug candidates;

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●

launching commercial sales of drugs, if and when approved, whether alone or in collaboration with others; and

●

obtaining and maintaining healthcare coverage and adequate reimbursement.

A change in the outcome of any of these variables with respect to the development of any of our drug candidates would significantly change the costs and timing associated with the development of that drug candidate. Because our drug candidates are in various stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our drug candidates or whether, or when, we may achieve profitability. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity or debt financings and collaboration ~~arrangements, including our existing collaboration with Pfizer.~~arrangements. Except for ~~Pfizer’s obligation~~amounts that we may sell under our 2022 Sales Agreement with Cowen, and Apollomics’ conditional obligations to make milestone and royalty payments to us under our existing license agreement, ~~with them,~~ we do not have any committed external source of liquidity.

To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of convertible debt securities, these securities could contain covenants that would restrict our operations.

We may require additional capital beyond our currently anticipated amounts. Additional capital may not be available on reasonable terms, or at all. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

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Outlook

Based on our research and development plans and our timing expectations related to the progress of our programs, we expect that our existing cash and cash equivalents ~~as of September 30, 2017~~ will enable us to fund our operating expenses and capital expenditure requirements ~~at least through the second half~~into late fourth quarter of ~~2019.~~2024. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing drug candidates in clinical trials is costly, and the timing of progress in these trials is uncertain.

Cash Flows

The following is a summary of our cash flows for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2023 and ~~2016:~~2022:


	Nine Months Ended September 30,

					Three Months Ended March 31,
(in thousands)	2017		2016		2023		2022
Net cash provided by (used in):
Operating activities	$	(21,399)	$	(23,777)	$	(11,607)	$	(13,698)
Investing activities		(260)		(266)		(2)		(41)
Financing activities		94,490		22,522		28,741		—
Net change in cash and cash equivalents	$	72,831	$	(1,521)	$	17,132	$	(13,739)

Operating Activities

Net cash used in operating activities for the ~~nine~~three months ended ~~September 30, 2017 included~~March 31, 2023 and 2022 was primarily the result of ongoing commercialization efforts and clinical and manufacturing costs associated with ~~the GMI-1271~~our uproleselan clinical development programs. ~~Net~~These cash ~~used in operating activities~~expenses were offset by non-cash expenses for ~~the nine months ended September 30, 2016 included the costs associated with the advancement of the GMI-1271~~stock-based compensation, lease expense and GMI-1359 development programs. In addition, the $2.0 million milestone license fee due to the University of Basel and accrued as a liability as of December 31, 2015 was paid during the nine months ended September 30, 2016.depreciation.

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Investing Activities

Net cash used in investing activities for the ~~nine~~three months ended ~~September 30, 2017 included capital expenses relating to the additional leasehold improvements~~March 31, 2023 and ~~the purchase of~~2022 was for computer and laboratory ~~equipment. Net cash used in investing activities for the nine months ended September 30, 2016 included capital expenses relating to the additional leasehold improvements including architect~~equipment and ~~project management fees.~~was not material.

Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2017 consisted primarily of the net proceeds of $86.8 million from our public offering in May 2017 and $7.4 million from at-the-market sales under our sales agreement with Cowen. Net cash provided by financing activities during the ~~nine~~three months ended ~~September 30, 2016 comprised~~March 31, 2023 primarily consisted of the net proceeds received from sales of ~~$19.8 million from~~ our ~~public offering in June 2016 and $2.7 million from at-the-market sales~~common stock under our ~~sales agreement~~at-the-market facility with ~~Cowen.~~

~~Off-Balance Sheet Arrangements~~

~~During~~Cowen of $28.7 million. There were no financing activities for the ~~nine~~three months ended ~~September 30, 2017, we did not have, and we do not currently have, any off-balance sheet arrangements,~~March 31, 2022.

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company as defined by Item 10 of Regulation S-K and are not required to provide the information otherwise required under ~~SEC rules.~~this item.

~~JOBS Act~~

In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107(b) of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period, and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

~~Item 3. Quantitative and Qualitative Disclosures about Market Risk~~

The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates. As of September 30, 2017 and December 31, 2016, we had cash and cash equivalents of $112.9 million and $40.0 million, respectively. We generally hold our cash in interest-bearing money market accounts. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents.

ITEM 4. CONTROLS AND PROCEDURES

~~Item 4. Controls and Procedures~~

(a) Evaluation of Disclosure Controls and Procedures

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the ~~Security and Exchange Commission’s~~SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

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In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure

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controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. ~~Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.~~

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of ~~September 30, 2017,~~March 31, 2023, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon such evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of such date at the reasonable assurance level.

(b) Changes in Internal Controls Over Financial Reporting

There have not been any changes in our internal controls over financial reporting during our fiscal quarter ended ~~September 30, 2017~~March 31, 2023 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

~~Item 1. Legal Proceedings~~

From time to time, we are subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.

ITEM 1A. RISK FACTORS

~~Item 1A. Risk Factors~~

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Our risk factors as of the date of this quarterly report on Form ~~10‑Q~~10-Q have not changed materially from those described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form ~~10‑K~~10-K for the fiscal year ended December 31, ~~2016,~~2022, filed with the ~~Securities and Exchange Commission~~SEC on March ~~1, 2017.~~29, 2023.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

~~Item 2. Unregistered Sales of Equity Securities and Use of Proceeds~~

None.

ITEM 5. OTHER INFORMATION

None.

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~~Item~~

ITEM 6. ~~Exhibits~~EXHIBITS


Exhibit No.		Document

~~Exhibit~~ ~~No.~~		~~Document~~

3.1		Amended and Restated Certificate of Incorporation of the Registrant (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form ~~8‑K~~8-K (File No. ~~001‑36177)~~001-36177), filed with the Commission on January 15, 2014).

3.2		Amended and Restated Bylaws of the Registrant (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Current Report on Form ~~8‑K~~8-K (File No. ~~001‑36177)~~001-36177), filed with the Commission on January 15, 2014).

4.1		Specimen stock certificate evidencing shares of Common Stock (incorporated herein by reference to Exhibit 4.2 to Amendment No. 2 to the Registrant’s Registration Statement on Form ~~S‑1~~S-1 (File No. ~~333‑191567)~~333-191567), filed with the Commission on October 31, 2013).

10.1+*		Release Agreement, dated February 13, 2023, by and between the Company and Armand Girard.

10.2+*		Transition Agreement dated February 21, 2023, by and between the Company and John Magnani, Ph.D.

10.3+*		Consulting Agreement dated March 31, 2023, by and between the Company and John Magnani, Ph.D.

10.4+*		Executive Employment Agreement, dated as of February 16, 2022, by and between the Registrant and Bruce Johnson

10.5+*		Executive Employment Agreement, dated as of February 10, 2023, by and between the Registrant and Chinmaya Rath

10.6		Third Amendment to Lease, dated April 19, 2023, by and between the Registrant and ARE-Maryland No. 45, LLC (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-36177), filed with the commission on April 21, 2023.

31.1*		Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act.

31.2*		Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act.

32.1**		Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act.

101.INS		XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document)

101.SCH		Inline XBRL Taxonomy Extension Schema Document

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document

104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

+ Indicates management contract or compensatory plan.

* Filed ~~herewith~~herewith.

** These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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SIGNATURES

~~SIGNATURES~~

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	GLYCOMIMETICS, INC.

Date: ~~November 8, 2017~~May 3, 2023	By:	/s/ Brian M. Hahn
		Brian M. Hahn
		Senior Vice President and Chief Financial Officer
		(On behalf of the Registrant and as Principal Financial Officer)

Delaware	06-1686563
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification No.)

9708 Medical Center Drive Rockville, Maryland	20850
(Address of principal executive offices)	(Zip Code)


Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value	GLYC	The Nasdaq Stock Market



				Weighted-Average
				Remaining	Aggregate
	Outstanding	Weighted-Average		Contractual Term	Intrinsic Value
	Options	Exercise Price		(Years)	(In thousands)
Outstanding as of December 31, 2016	729,819	$	1.26	3.2
Options exercised	(16,608)		1.65
Options forfeited	—		—
Outstanding as of September 30, 2017	713,211		1.25	2.4	$	9,089
Vested as of September 30, 2017	713,211		1.25	2.4	$	9,089
Exercisable as of September 30, 2017	713,211		1.25	2.4	$	9,089


	Nine Months Ended	Nine Months Ended
	September 30, 2017	September 30, 2016
Expected term	6.25 years	6.25 years
Expected volatility	75.20%	68.86%
Risk-free interest rate	2.08%	1.69%
Expected dividend yield	0%	0%



			Weighted-Average
		Number	Grant Date
	of Shares			Fair Value
Unvested at December 31, 2016		16,916	$	5.04
Granted		—		—
Forfeited		—		—
Vested		4,833		4.61
Unvested at September 30, 2017		12,083		5.21