Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q


(Mark one)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2017March 31,2022

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-36177


GlycoMimetics, Inc.

(Exact name of registrant as specified in its charter)


Delaware

06-1686563

(State or 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)

(240) (240243-1201

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)


Securities registered pursuant to Section 12(b) of the Act:

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

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  ◻ 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes      No  ◻ 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer Accelerated filer ☒Filer Accelerated Filer Smaller reporting company Reporting Company

Non-accelerated filer          (Do not check if a smaller reporting company)Filer   Emerging Growth Company

                                                                Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).    Yes      No  

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of the close of business on November 7, 2017April 27, 2022 was 34,337,799.52,392,444.


GLYCOMIMETICS, INC.

INDEX TO FORM 10-Q


Part I. FINANCIAL INFORMATIONINFORMATION

ITEM 1. FINANCIAL STATEMENTS

Item 1. Financial Statements

GLYCOMIMETICS, INC.

Balance Sheets

Balance Sheets

March 31, 

December 31, 

 

2022

2021

 

Assets

    

(Unaudited)

    

Current assets:

Cash and cash equivalents

$

76,516,226

$

90,254,890

Prepaid expenses and other current assets

 

947,392

 

533,804

Total current assets

 

77,463,618

 

90,788,694

Property and equipment, net

 

350,055

 

368,842

Prepaid research and development expenses

 

2,221,407

 

1,560,607

Deposits

52,320

52,320

Operating lease right-of-use asset

1,377,371

1,576,185

Total assets

$

81,464,771

$

94,346,648

Liabilities & stockholders’ equity

Current liabilities:

Accounts payable

$

2,276,173

$

2,107,615

Accrued expenses

 

9,477,026

 

8,715,368

Lease liabilities

 

1,028,534

 

1,001,407

Total current liabilities

 

12,781,733

 

11,824,390

Lease liabilities, net of current portion

651,786

918,607

Total liabilities

 

13,433,519

 

12,742,997

Stockholders’ equity:

Preferred stock; $0.001 par value; 5,000,000 shares authorized, 0 shares issued and outstanding at March 31, 2022 and December 31, 2021

 

 

Common stock; $0.001 par value; 100,000,000 shares authorized; 52,392,444 shares issued and outstanding at March 31, 2022; 52,313,894 shares issued and outstanding at December 31, 2021

 

52,392

 

52,314

Additional paid-in capital

 

455,528,891

 

454,448,327

Accumulated deficit

 

(387,550,031)

 

(372,896,990)

Total stockholders’ equity

 

68,031,252

 

81,603,651

Total liabilities and stockholders’ equity

$

81,464,771

$

94,346,648

 

 

 

 

 

 

 

 

 

 

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.

3


 

GLYCOMIMETICS, INC.

Unaudited Statements of OperationsOperations 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, 

2022

2021

Revenue from collaboration and license agreements

    

$

    

$

1,055,441

Costs and expenses:

Research and development expense

 

9,603,922

 

11,147,236

General and administrative expense

 

5,056,188

 

4,188,110

Total costs and expenses

 

14,660,110

 

15,335,346

Loss from operations

 

(14,660,110)

 

(14,279,905)

Interest income

 

7,069

 

5,846

Net loss and comprehensive loss

$

(14,653,041)

$

(14,274,059)

Basic and diluted net loss per common share

$

(0.28)

$

(0.28)

Basic and diluted weighted-average number of common shares outstanding

 

52,331,391

 

50,697,183

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

4


GLYCOMIMETICS, INC.

Unaudited Statements of Cash FlowsStockholders’ 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

 

Three Months Ended March 31, 2022

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

Three Months Ended March 31, 2021

Additional

Total

Common Stock

Paid-In

Accumulated

Stockholders’

Shares  

Amount  

Capital

Deficit

Equity

Balance at December 31, 2020

 

49,017,622

$

49,018

$

437,639,991

$

(309,469,553)

$

128,219,456

Issuance of common stock, net of issuance costs

2,517,603

2,517

9,557,182

9,559,699

Exercise of options

 

3,785

 

4

 

4,235

 

 

4,239

Stock-based compensation

 

 

 

1,614,185

 

 

1,614,185

Net loss

 

 

 

 

(14,274,059)

 

(14,274,059)

Balance at March 31, 2021

 

51,539,010

$

51,539

$

448,815,593

$

(323,743,612)

$

125,123,520

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

5


GLYCOMIMETICS, INC.

Unaudited Statements of Cash Flows

Three Months Ended March 31, 

    

2022

    

2021

Operating activities

Net loss

$

(14,653,041)

$

(14,274,059)

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

Depreciation

 

59,308

 

68,088

Loss on disposal of assets

2,174

Non-cash lease expense

198,814

180,586

Stock-based compensation

 

1,080,642

 

1,614,185

Changes in assets and liabilities:

Prepaid expenses and other current assets

 

(413,588)

 

85

Prepaid research and development expenses

(660,800)

Accounts payable

 

168,558

 

50,861

Accrued expenses

 

761,658

 

(1,552,381)

Lease liabilities

(239,694)

(214,810)

Net cash used in operating activities

 

(13,698,143)

 

(14,125,271)

Investing activities

Purchases of property and equipment

 

(40,521)

 

(3,060)

Net cash used in investing activities

 

(40,521)

 

(3,060)

Financing activities

Proceeds from issuance of common stock, net of issuance costs

 

 

9,559,699

Proceeds from exercise of stock options

 

 

4,239

Net cash provided by financing activities

 

 

9,563,938

Net change in cash and cash equivalents

 

(13,738,664)

 

(4,564,393)

Cash and cash equivalents, beginning of period

 

90,254,890

 

137,035,017

Cash and cash equivalents, end of period

$

76,516,226

$

132,470,624

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

6

GLYCOMIMETICS, INC.

Notes to Unaudited Financial StatementsStatements

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 clinical stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. Glycomimetics are molecules that mimic the structure of carbohydrates involved in important biological processes. The Company’s proprietary glycomimetics platform is based onUsing its expertise in carbohydrate chemistry and its understandingknowledge of the role carbohydrates play in key biological processes. Using this expertise and understanding,carbohydrate biology, the Company is developing a pipeline of proprietary glycomimetics designed tothat inhibit disease-related functions of carbohydrates, such as the roles they play in inflammation, cancer and infection.

2. Going Concern

The accompanying unaudited financial statements have been prepared assuming that the Company will continue as a going concern within one year after the date that the financial statements are issued. During 2021, the Company incurred a net loss of $63.4 million and had net cash flows used in operating activities of $57.5 million. At March 31, 2022, the Company had $76.5 million in cash and cash equivalents and had no committed source of additional funding from either debt or equity financings, although the Company may, in its discretion, sell equity securities under the terms of its existing at-the-market sales agreement (see Note 8), subject to certain conditions and limitations. Management believes that given the Company’s current cash position and forecasted negative cash flows from operating activities over the next twelve months, including the completion of its planned Phase 3 clinical trial of uproleselan, there is substantial doubt about its ability to continue as a going concern after the date that is one year from the date that these unaudited financial statements are issued, without obtaining additional financing or entering into another form of non-equity or debt arrangement.

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 commercial operations. The Company is subject to a number of risks similar to those of other companies 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 has relied on its ability to fund its operations is dependent upon management’s plans, which include raising additional capital in the near term primarily through privatea combination of equity and public equitydebt financings, collaborations, strategic alliances and management expects operating lossesmarketing, distribution or licensing arrangements and negative operating cash flowsin the longer term, from revenue related to continue forproduct sales, to the foreseeable future. Asextent its product candidates receive marketing approval and can be commercialized. There can be no assurances that new financings or other transactions will be available to the Company continueson commercially acceptable terms, or at all. Also, any collaborations, strategic alliances and marketing, distribution or licensing arrangements may require the Company to incur losses, profitability will be dependent upon the successful development, approval, and commercializationgive up some or all of its drug candidates and achievingrights to a levelproduct or technology, which in some cases may be at less than the full potential value of revenues adequatesuch rights. If the Company is unable to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does,obtain additional capital, the Company will continue to need to raise additional capital. Management intends to fund future operations through additional public or private equity or debt offeringsassess its capital resources and may seek additional capital through arrangements with strategic partnersbe required to delay, reduce the scope of or from other sources.eliminate some or all of its operations, which may have a material adverse effect on the Company’s business, financial condition, results of operations and ability to operate as a going concern.

The accompanying unaudited financial statements do not include any adjustments that might be necessary if the Company is not able to continue as a going concern.

2.

3. 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, 2021, filed with the United States Securities and Exchange Commission (the SEC) on March 3, 2022 (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).

7

Unaudited Financial Statements

The accompanying balance sheet as of September 30, 2017 andMarch 31, 2022, statements of operations and comprehensive loss and stockholders’ equity for the three and nine months ended September 30, 2017March 31, 2022 and 20162021 and statements of cash flows for the ninethree months ended September 30, 2017March 31, 2022 and 20162021 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, 20162021 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, theMarch 31, 2022 and its results of operations and changes in its stockholders’ equity for the three and nine months ended September 30, 2017March 31, 2022 and 20162021 and its cash flows for the ninethree months ended September 30, 2017March 31, 2022 and 2016.2021. The December 31, 20162021 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, 2017March 31, 2022 and 20162021 are unaudited. Interim results are not necessarily indicative of results for an entire year.year or for any future period.

6


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 no0 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, 2017March 31, 2022 and December 31, 2016.2021. The carrying value of cash held in money market funds of approximately $110.9$74.5 million and $38.0$88.3 million as of September 30, 2017March 31, 2022 and December 31, 2016,2021, respectively, is included in cash and cash equivalents and approximates market values based on quoted market prices (Level 1 inputs). The Company did 0t transfer any assets measured at fair value on a recurring basis between levels during the three months ended March 31, 2022 and 2021.

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 and cash equivalents consist of money market funds with major financial institutions in the United States. These funds may be redeemed upon demand and, therefore, bear minimal risk. 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 to the extent of costs incurred in connection with performance under such grant arrangements.

The Company has entered into a collaborative researchapplies 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 agreementfinancial 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 isthe customer(s); (ii) identify the performance obligations in the formcontract; (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

8

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 Topic 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 paymentfees; development, regulatory and commercial milestone payments upon achieving significant milestone events. The Pfizer Agreement also contemplates royalty paymentspayments; and royalties on futurenet sales of an approved product. There are no performance, cancellation, termination, or refund provisions in the Pfizer Agreementlicensed 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 consequencesrequire judgment to determine the Company.stand-alone selling price, 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 worldwideLicensing of Intellectual Property: If the license to the Company’s rivipansel compound, butintellectual 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 ofrecognizes revenue from non-refundable, up-front license fees research payments, and milestone payments. Agreements with multiple components (deliverables or items) are evaluated accordingallocated to the provisionslicense 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 unitcombined 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 unitmeasuring 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

7


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 satisfiedevaluates the deliverables undermeasure 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, atPayments: At the inception of agreementseach arrangement that includeincludes 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 partiespayments based on the basislevel of sales, and for which the contingent naturelicense 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 deliverablesroyalty 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 withinSupply: 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 factorsoutsources a significant portion of these clinical trial activities to third parties. The accrual for site and patient

9

costs includes inputs such as scientific, regulatory, commercialestimates 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 investmentpass-through costs. These inputs are required to achievebe estimated due to a lag in receiving the respective milestoneactual 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 whetherare 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 achievedbalance sheets as a resultprepaid 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 paymentsestimates may be made in advancedetermining the accrued balances at the end of services, research and development costsany reporting period. Actual results could differ from the estimates made. The Company’s historical clinical accrual estimates have not been materially different from the actual costs. Clinical trial accruals that are expenseddue longer than one year are classified as incurred. For payments made in advance, the Company recognizes research and development expense as 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 costs

8noncurrent accrued expenses.


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 toThe 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).

9

10


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 averageweighted-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, 

    

    

2022

    

2021

    

Stock options and RSUs

 

 

9,789,833

 

7,088,005

 

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, 2017March 31, 2022 and 2016,2021, the Company’s net loss equaled comprehensive net loss and, accordingly, no additional disclosure is presented.

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

10


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, thereThere 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, 2022.

3.

4. 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, 

2022

    

2021

Prepaid research and development expenses

$

459,866

$

273,396

Other prepaid expenses

482,751

259,061

Other receivables

 

 

75,648

 

 

268,659

 

 

4,775

 

1,347

Deposits

 

 

 —

 

 

10,649

 

Prepaid expenses and other current assets

 

$

1,015,747

 

$

478,503

 

$

947,392

$

533,804

4.5. Property and Equipment

Property and equipment, net consists of the following:

 

 

 

 

 

 

 

 

September 30, 

 

December 31, 

 

    

2017

    

2016

 

March 31, 

December 31, 

    

2022

    

2021

Furniture and fixtures

 

$

314,024

 

$

262,135

 

$

346,906

$

345,712

Laboratory equipment

 

 

1,282,655

 

 

1,130,180

 

 

1,440,088

 

1,406,346

Office equipment

 

 

11,084

 

 

6,610

 

 

17,762

 

17,762

Computer equipment

 

 

191,825

 

 

169,423

 

 

311,369

 

305,784

Leasehold improvements

 

 

573,165

 

 

36,128

 

616,133

616,133

Construction in progress

 

 

 —

 

 

508,417

 

Property and equipment

 

 

2,372,753

 

 

2,112,893

 

 

2,732,258

 

2,691,737

Less accumulated depreciation

 

 

(1,250,537)

 

 

(1,056,561)

 

 

(2,382,203)

 

(2,322,895)

Property and equipment, net

 

$

1,122,216

 

$

1,056,332

 

$

350,055

$

368,842

Depreciation expense was $70,060$59,308 and $45,808$68,088 for the three months ended September 30, 2017March 31, 2022 and 2016, respectively, and $193,976 and $139,749 for the nine months ended September 30, 2017 and 2016,2021, respectively.

5.11

6. 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, 

2022

2021

Accrued research and development expenses

$

7,401,146

$

5,824,365

Accrued bonuses

1,051,123

2,152,302

Accrued consulting and other professional fees

 

347,476

 

299,607

Accrued employee benefits

 

567,386

 

348,752

Other accrued expenses

 

109,895

 

90,342

Accrued expenses

$

9,477,026

$

8,715,368

11

7. Leases


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 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 LeasesThe 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 overincentive in the terminitial 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 to the Company’s renewal option set forth in the Lease.

The Company’s one-time option to terminateCompany identified and applied the following significant assumptions in recognizing the right-of-use asset and corresponding liability for the Lease effectiveand 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. The Company’s renewal option to extend was not reasonably certain of being exercised as of March 31, 2022.

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.

12

As of March 31, 2020 also applies to2022, the additional space.

Deferred rent related to the Leaseweighted-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’s1.6 years. There were 0 additional operating leases was $223,337 and $219,983 forentered into during the three months ended September 30, 2017March 31, 2022.

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, 

2022

   

2021

Operating lease cost

$

231,989

$

231,989

Variable lease cost

151,132

146,421

Total operating lease cost

$

383,121

$

378,410

Cash paid for amounts included in the measurement of lease liabilities:

Operating cash outflows for operating leases

$

272,870

$

266,215

Maturities of lease liability due under these lease agreements as of March 31, 2022 were as follows:

7.

Operating Lease

    

Obligation

April 1, 2022 - December 31, 2022

$

831,488

2023

940,840

Thereafter

Total

1,772,328

Present value adjustment

(92,008)

Present value of lease payments

$

1,680,320

8. Stockholders’ Equity

At-The-Market Equity OfferingSales Facility

On March 1, 2016,In October 2020, the Company entered into an at-the-market sales agreement (the 2020 Sales Agreement) with Cowen and Company, LLC to sell(Cowen). There were 0 shares sold under the Company’s securities under a shelf registration statement filed in2020 Sales Agreement during the three months ended March 2015. The at-the market sales agreement was terminated on May 23, 2017.31, 2022. During the ninethree months ended September 30, 2017,March 31, 2021, the Company issued and sold 1,388,6472,517,603 shares of common stock under the at-the-market sales agreement. The shares were sold2020 Sales Agreement at a weighted average price per share of $5.55,$3.92, for aggregate net proceeds of $7.4$9.6 million, after deducting commissions and offering expenses. As of March 31, 2022, approximately $85.1 million remained available to be sold under the terms of the 2020 Sales Agreement. Subsequent to March 31, 2022, there have been 0 additional sales under the 2020 Sales Agreement.

On September 28, 2017,In March 2022, the Company filed a shelf registration statement with the SEC, which was declared effective on April 22, 2022. On April 28, 2022, the Company terminated the 2020 Sales Agreement and entered into a new at-the-market sales agreement (the 2022 Sales Agreement) with Cowen and Company, LLC to sellCowen. Under the Company’s securities under a shelf registration statement filed in September 2017. Subsequent to September 30, 2017,2022 Sales Agreement, the Company issued and sold 1,600,000 shares of common stock under the at-the-market sales agreement. The shares were sold at a weighted average price per share of $12.50, for aggregate net proceeds of $19.2may sell up to $100.0 million after deducting commissions and offering expenses.

Equity Offering

In May 2017, 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.stock.

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 value 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-eighthforty-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.

12

13


A summary of the Company’s stock option activity under the 2003 Plan for the ninethree months ended September 30, 2017March 31, 2022 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

 

 

WEIGHTED-

AGGREGATE

 

WEIGHTED-

AVERAGE

INTRINSIC

 

AVERAGE

REMAINING

VALUE

 

OUTSTANDING

EXERCISE

CONTRACTUAL

(IN

OPTIONS

    

PRICE

    

TERM (YEARS) 

    

THOUSANDS)

Outstanding as of December 31, 2021

93,465

$

2.00

 

0.3

Options exercised

 

Options forfeited

(73,859)

 

1.98

Outstanding, Vested and Exercisable as of March 31, 2022

19,606

 

2.07

 

0.3

$

As of September 30, 2017, theMarch 31, 2022, outstanding options under the 2003 Plan were fully expensed. Total intrinsic value of theexpensed and all shares underlying outstanding options were fully vested. There were 0 options exercised during the ninethree months ended September 30, 2017 and 2016March 31, 2022. Total intrinsic value for the 3,785 options exercised during the three months ended March 31, 2021 was $103,638 and $95,221, respectively,$8,668 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.$4,239.

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. The 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 unitRSU awards, stock appreciation rights, performance stock awards and other forms of stock compensation to its employees, including officers, consultants and directors. The 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 atwith the rate of one forty-eighthbalance of the option shares per monthvesting in a series of NaN successive equal monthly installments as of the first day of each month aftermeasured 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.

On April 5, 2022, the board of directors approved an amendment and restatement of the 2013 Plan, subject to the approval of the Company’s stockholders at its annual meeting of stockholders to be held in May 2022 (the Amended Plan).

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 2003 Plan that expire or terminate without having been exercised in full or are forfeited to or repurchased by the Company. The number of shares of common stock reserved for issuance under the 2013 Plan has automatically increasesincreased on January 1 of each year untilthrough January 1, 2023,2022, by 3% of the total number of shares of common stock 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. If the Amended Plan is approved by the Company’s stockholders, the existing share reserve under the 2013 Plan will be 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 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 2013 Plan is 20,000,000 shares. As

14

Shares issued under the 2013 Plan may be authorized but unissued or reacquired shares of common stock. Shares subject to stock awards granted under the 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 2013 Plan. Additionally, shares issued pursuant to stock awards under the 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

13


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

A summary of the Company’s stock option activity under the 2013 Plan for the ninethree months ended September 30, 2017March 31, 2022 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, 2021

5,655,457

$

8.30

6.0

Options granted

1,825,100

1.11

Options exercised

Options forfeited

(125,980)

11.13

Outstanding as of March 31, 2022

7,354,577

6.46

6.8

$

55

Vested or expected to vest as of March 31, 2022

7,140,377

6.62

6.8

48

Exercisable as of March 31, 2022

4,367,434

9.11

5.2

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, 2022, there was $4,854,266$5,361,718 of total unrecognized compensation expense related to unvested options under the 2013 Plan that will be recognized over a weighted-average period of approximately 2.22.3 years. Total intrinsic value of theThere were 0 options exercised under the 2013 Plan during the ninethree months ended September 30, 2017March 31, 2022 and 2016 was $228,291 and $2,275, respectively, and total cash received for options exercised was $193,669 and $27,825 during the nine months ended September 30, 2017 and 2016, respectively.2021. The total fair value of shares underlying options which vested in the ninethree months ended September 30, 2017March 31, 2022 and 20162021 was $2,872,004$1,263,094 and $2,364,683,$2,269,172, respectively.

A restrictedIn January 2022, the Company granted stock unit (RSU)options to purchase an aggregate of 214,200 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 $171,360 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, 2022. 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 January 2021, the Company awarded RSUs under the 2013 Plan to all of its employees. The Company hasRSUs 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 withby the Company.Company at the applicable vesting date. Compensation expense is recognized on a straight-line basis. As of September 30, 2017,March 31, 2022, there was $30,763$849,932 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 2.8 years.

15

The following is a summary of RSU activity under the 2013 Plan for the ninethree 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, 2022:

 

Weighted-Average

 

Number of Shares

Grant Date

 

Underlying RSUs

    

Fair Value

 

Unvested at December 31, 2021

345,600

$

3.70

Granted

 

Forfeited

 

Vested

(78,550)

 

3.81

Unvested at March 31, 2022

267,050

 

3.66

Inducement Plan

In January 2020, the Company’s board of directors adopted the GlycoMimetics, Inc. Inducement Plan (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 NaN 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. There were 500,000 shares of common stock reserved under the Inducement Plan at its adoption date. In August 2021, the Company’s board of directors adopted an amendment to the Inducement Plan to increase the number of shares reserved to 2,000,000 shares, and in January 2022 the Company’s board of directors adopted an amendment to the Inducement Plan to further increase the number of shares reserved to 3,000,000 shares.

A summary of the Company’s stock option activity under the Inducement Plan for the three months ended March 31, 2022 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, 2021

1,813,600

$

2.08

9.6

Options granted

335,000

1.13

Options exercised

Options forfeited

Outstanding as of March 31, 2022

2,148,600

1.93

9.4

$

16

Vested or expected to vest as of March 31, 2022

1,564,400

1.91

9.4

14

Exercisable as of March 31, 2022

27,004

3.59

8.3

As of March 31, 2022, there was $1,796,675 of total unrecognized compensation expense related to unvested options under the Inducement Plan that will be recognized over a weighted-average period of approximately 3.4 years. The total fair value of shares underlying options which vested in the three months ended March 31, 2022 and 2021 was $10,667 and $2,205, respectively. There were 0 options exercised under the Inducement Plan during the three months ended March 31, 2022 and 2021.

During 2021 and the three months ended March 31, 2022, 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

14

16


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, 2022. 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, 2022 and 2021 was $0.80 per share and $2.70 per share, respectively, applying the Black-Scholes-Merton option pricing model utilizing the following weighted-average assumptions:

    

2022

2021

Expected term

 

6.25 years

6.25 years

Expected volatility

 

84.51%

83.72%

Risk-free interest rate

 

1.66%

0.63%

Expected dividend yield

 

0%

0%

Stock-based compensation expense was classified on the statementstatements of operations as follows for the three and nine months ended September 30, 2017March 31, 2022 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

 

2021:

Three Months Ended March 31, 

    

2022

2021

Research and development expense

$

318,825

$

688,972

General and administrative expense

 

761,817

 

925,213

Total stock-based compensation expense

$

1,080,642

$

1,614,185

8.9. Income Taxes

The Company has not recorded any tax provision or benefit for the ninethree months ended September 30, 2017March 31, 2022 and 2016.2021. 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, 2017March 31, 2022 and December 31, 2016.2021.

10. License and Collaboration Agreements

9. Research and License Agreements

Apollomics

In October 2011,January 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 June 2020, the Company and PfizerApollomics entered into the Pfizer Agreement that provides Pfizer an exclusive worldwide licensea 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 manufacture of the Products after appropriate material transfer requirements are met. During the three months ended March 31, 2021, the Company recognized $1.1 million as revenue from the sale of clinical supplies to Apollomics. The Company was responsible for completiondid not recognize revenue under the clinical supplies agreement during the three months ended March 31, 2022.

17

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 2Products. 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 the first quarter of 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 furtherand 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 executionwill 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 September 2020, the Company received an up-fronta 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 upbridging study design to two indications and the first commercial sale of a licensed productsupport registration in the United States and selected European countries for up to two indications; potential milestone payments of 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 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.

China. 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 other 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 $22.5this $1.0 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 three months ended September 30, 2020. 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, 2017March 31, 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.

11. Risks and Uncertainties

COVID-19

The impact of the continuing COVID-19 pandemic on the Company’s business and financial performance is uncertain and depends on various factors, including the duration of the pandemic, government restrictions and other actions, including relief measures and mass vaccination efforts, implemented to address the impact of the pandemic, and resulting impacts on the financial markets and overall economy. The imposition of directives by state and federal governments in the United States as well as governments in other regions of the world in response to the COVID-19 pandemic, including in locations in which its Phase 3 clinical trial of uproleselan is being conducted, did previously result in some delays associated with the trial. COVID-19 infection rates continue to fluctuate, particularly with the emergence of variants and sub-variants, which could still negatively affect the completion of the trial on the timeline that the Company currently expects. The Company is unable to determine the extent of the impact of the pandemic on its operations and financial condition going forward. These developments are highly uncertain and unpredictable, and may materially adversely affect the Company’s financial position and results of operations. The Company continues to closely monitor the COVID-19 situation and any potential impact to its planned activities.

15

18


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, 2016,2021, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange CommissionSEC on March 1, 2017.3, 2022.

Overview

We are a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycomimeticsWe are developing a pipeline of proprietary glycomimetics, which 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 carbohydratescarbohydrate structures to the surface of the proteins. The addition of these carbohydrate structuressuch proteins, which affects the functions of thesethe 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 designidentify highly effective selectin antagonists and other glycomimetics that may inhibit the disease-related functions of certain carbohydrates.

We are focusing our initial efforts oncarbohydrates in order to develop novel drug candidates for rareto 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.

16


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 whichthat 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 area life-threatening hematologic cancers,cancer, and potentially other hematologic cancers as well. cancers. In 2021, we completed enrollment of patients in a randomized, double-blind, placebo-controlled Phase 3 pivotal clinical trial to evaluate uproleselan in individuals with relapsed/refractory AML, the design of which was based on guidance received from the U.S. Food and Drug Administration, or FDA. Based on current projections, we anticipate reaching the overall survival events trigger mid-year 2023, with top line data disclosure shortly thereafter.

19

We have completed enrollment inalso entered into a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute, or NCI, part of the National Institutes of Health, to conduct a Phase 1/22/3 randomized, controlled clinical trial testing the addition of GMI-1271 as an adjunctuproleselan to a standard chemotherapy in patients with AML and are currently conducting a Phase 1 clinical trialregimen. Enrollment of GMI-1271 combined with chemotherapy for the treatment of MM. In the Phase 2 portion was completed in December 2021. There will be a planned interim analysis that will evaluate event-free survival and whether the pre-specified threshold for continuing to Phase 3 has been met. The trial may also provide support for regulatory filings, if the results of the planned interim analysis are sufficiently positive.

Uproleselan is also being studied in multiple investigator-sponsored trials, with data readouts from some or all of these trials expected in 2022.

We have rationally designed an innovative antagonist of E-selectin, GMI-1687, that could be a subcutaneously administered treatment. Initially developed as a potential life-cycle extension to uproleselan, we believe that GMI-1687 could be developed to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. We are currently conducting preclinical activities and studies with GMI-1687 to support our AML clinical trial, AML patients treated 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 oneplanned submission of an investigational new drug application, 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 fromIND, to the FDA in May 2015 for the treatmentfirst half of AML. In June 2016, GMI-1271 received fast track designation from the FDA for the treatment 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 on2022.

We are also developing 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 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 AMLdrug candidate, GMI-1359, that simultaneously targets both E-selectin and a second cohort comprised of 47 patients with relapsed or refractory AML were enrolled.  Unlike in the Phase 1 portion, some of the patients in the Phase 2 portion were treated with multiple cycles of GMI-1271.chemokine receptor known as CXCR4. In May 2017, we completed enrollment of 91 patients in the Phase 1/2 trial. We plan 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 trial that could support an application for marketing approval for GMI-1271 for the treatment of AML. Based on the feedback from the FDA,2021, we plan to initiate this pivotal trial in mid-2018.

In June 2017, we presented new data from the Phase 2 portion of the trial 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 American Society of Hematology, or ASH, to be held in December 2017. One of these presentations will be an update on the current data set from the Phase 1/2 open-label trial of GMI-1271 as an adjunct 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, which we believe can be reversed by treatment with GMI-1271.

17


In December 2015, at the ASH annual meeting, we presented preclinical data suggesting that GMI-1271 could reverse resistance of certain chemotherapies seen in MM. In September 2016, we dosed the first patient interminated 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 and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow, we believe that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment 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, 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 a Phase 1 single-dose escalation1b trial of GMI-1359 in healthy volunteers. In this trial, volunteer participants received a single injection 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.hormone receptor positive breast cancer patients whose tumors have spread to bone. We are currently expanding enrollment in this trial with two additional cohorts and anticipate selectingalso advancing other preclinical-stage programs, including small-molecule glycomimetic compounds that inhibit the protein galectin-3, which we believe may have potential to be an initial cancer indicationorally administered treatment for 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.

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, upfrontup-front and milestone payments under our license and collaboration with Pfizeragreements 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 upfrontup-front and milestone payments from Pfizer, although we have received nominal amounts of revenue under research grants.

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 ourlicense and 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.agreements.

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$387.6 million as of September 30, 2017,March 31, 2022 and we expect to continue to incur significant expenses and operating losses over at least the next 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

18


receipt of milestone payments, if any, under our collaboration with Pfizer, and our expenditures on other research and development activities. We anticipate that ourOur forecasted expenses include those we will increase substantially as we:need to undertake in order to:

·

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

supply commitments related to the ongoing clinical trials of uproleselan;

·

continue the researchconduct NDA-enabling activities related to manufacture, toxicology and development ofclinical pharmacology for our other drugproduct candidates;

·

seek to discovermanufacture additional uproleselan drug supplies for validation and develop additional drug candidates;

prepare for commercialization;

·

seek regulatory approvals for any 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 any drug candidates other than rivipansel for which we may obtain regulatory approval;

·

maintain, expand and protect our intellectual property portfolio;

·

hire additional clinical, quality controlmaintain 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, potentially including the use of our at-the-market sales facility with Cowen, or through collaborations or partnerships with other companies. 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 throughinto the second halfquarter of 2019.2023 without giving effect to potential business development opportunities, such as upfront or milestone payments under

20

license and collaboration agreements, or additional financing activities including the potential sale of 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.

Our Collaboration with Pfizerand License Agreements

Apollomics

In October 2011,January 2020, we entered into thean exclusive collaboration and license agreement with Pfizer under which we granted Pfizer an exclusive worldwide license to developApollomics (Hong Kong) Limited, or Apollomics, for the development and commercialize products containing rivipansel for all fieldscommercialization of uproleselan and uses. The licenseGMI-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 to advance the preclinical and clinical development of GMI-1687. We received an upfront cash payment of $9.0 million and in September 2020 received a $22.5$1.0 million upfrontdevelopment milestone payment. We are also eligibleSubject to earn potential milestone payments of up to $115.0 million upon the achievement of specified development milestones, including the dosingterms 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 doublehigh 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 underIn September 2020, the Pfizer agreement was $35.0 million uponChina National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) granted IND approval for uproleselan (also known as APL-106), enabling the initiation of dosinga 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 January 2021, APL-106 was granted Breakthrough Therapy Designation from the China NMPA CDE for the treatment of relapsed/refractory AML. In March 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 ofenrolled the first patient in the Phase 3 clinicalportion of the trial in November 2021.

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.

19


We2020, we entered into a research servicesclinical 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 owemanufacture 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 respectoption 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 duringbegin manufacture after appropriate material transfer requirements are met. During the year ended December 31, 2015, at2021, we recognized $1.1 million in revenue from the timesale of clinical supplies to Apollomics under the payments became due to the University.clinical supply agreement. There werewas no additional payments due to the Universityrevenue recognized from Apollomics for the three months or nine months ended September 30, 2017.March 31, 2022.

Critical Accounting Policies and Significant Judgments and Estimates

ThereOur 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 U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to our revenue recognition, accrued research and development expenses, stock-based compensation expense and income taxes. We base our estimates on historical experience, known trends and events and various other factors that we believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other resources. Actual results may differ from these 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 changesrevisions 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 duringabout 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 tospecific 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, 2016.2021. There have not been any material changes to our critical accounting policies and estimates since December 31, 2021.

21

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 organizationsCROs and other consultants and other outside expenses. Other preclinical research and platform programs include 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 and our other drug candidates 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, itIt 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

20


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;

patients, which could be lengthened as a result of the ongoing COVID-19 pandemic;

·

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.

22

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 as we start to supportbuild upon our continued research and development activities.commercialization efforts for uproleselan.

OtherInterest Income

OtherInterest income consists of interest income earned on our cash and cash equivalents.

21


Results of Operations for the Three and Nine Months Ended September 30, 2017March 31, 2022 and 20162021

The following tables settable sets forth our results of operations foroperations:

 

Three Months Ended March 31, 

Increase/(Decrease)

(dollars in thousands)

    

2022

    

2021

    

    

Revenue

$

$

1,055

$

(1,055)

(100)

%

Costs and expenses:

                        

Research and development expense

 

9,604

 

11,147

 

(1,543)

(14)

%

General and administrative expense

 

5,056

 

4,188

 

868

21

%

Total costs and expenses

 

14,660

 

15,335

 

(675)

(4)

%

Loss from operations

 

(14,660)

 

(14,280)

 

(380)

3

%

Interest income

 

7

 

6

 

1

17

%

Net loss and comprehensive loss

$

(14,653)

$

(14,274)

$

(379)

3

%

Revenue

There was no revenue recognized during 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)

 

March 31, 2022. During the three months ended March 31, 2021, we recognized $1.1 million in revenue from the sale of clinical supplies to Apollomics under the clinical supply agreement.

Research and Development Expense

The following tables summarize our research and development expense by functional area for the three and nine months ended September 30, 2017March 31, 2022 and 2016:2021:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

Period-to-Period

 

(in thousands)

 

2017

 

2016

 

Change

 

Three Months Ended March 31, 

Increase/(Decrease)

(dollars in thousands)

    

2022

    

2021

    

Clinical development

    

$

1,109

    

$

2,389

    

$

(1,280)

 

$

3,016

$

4,654

$

(1,638)

(35)

%

Manufacturing and formulation

 

1,893

 

893

 

1,000

 

 

2,942

 

2,290

 

652

28

%

Contract research services, consulting and other costs

 

308

 

332

 

(24)

 

 

389

 

542

 

(153)

(28)

%

Laboratory costs

 

499

 

466

 

33

 

 

499

 

513

 

(14)

(3)

%

Personnel-related

 

1,644

 

1,580

 

64

 

 

2,439

 

2,459

 

(20)

(1)

%

Stock-based compensation

 

 

327

 

 

261

 

 

66

 

319

689

(370)

(54)

%

Research and development expense

 

$

5,780

 

$

5,921

 

$

(141)

 

$

9,604

$

11,147

$

(1,543)

(14)

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

22

23


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 summarizetable summarizes our research and development expense by drug candidate for the three and nine months ended September 30, 2017March 31, 2022 and 2016:2021:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

Period-to-Period

 

(in thousands)

 

2017

 

2016

 

Change

 

GMI-1271

    

$

2,921

    

$

2,799

    

$

122

 

Three Months Ended March 31, 

Increase/(Decrease)

(dollars in thousands)

    

2022

    

2021

Uproleselan

$

5,286

$

6,727

$

(1,441)

(21)

%

GMI-1687

812

201

 

611

304

%

GMI-1359

 

253

 

715

 

(462)

 

44

234

 

(190)

(81)

%

Other research and development

 

635

 

565

 

70

 

 

704

 

837

 

(133)

(16)

%

Personnel-related and stock-based compensation

 

 

1,971

 

 

1,842

 

 

129

 

 

2,758

 

3,148

 

(390)

(12)

%

Research and development expense

 

$

5,780

 

$

5,921

 

$

(141)

 

$

9,604

$

11,147

$

(1,543)

(14)

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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, 2022 decreased by $1.5 million compared to the same period ended March 31, 2021 primarily due to:

decreased clinical trial and development costs related to our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML as patient enrollment ended in October 2021; and

decreased stock-based compensation expense due to lower share prices, resulting in lower grant date fair market values for equity awards.

These decreases were partially offset by:

increased manufacturing costs for uproleselan validation batches; and

increased costs for toxicity studies of GMI-1687.

General and Administrative Expense

The following tables summarizetable summarizes the components of our general and administrative expense for the three and nine  months ended September 30, 2017March 31, 2022 and 2016:2021:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

Period-to-Period

 

(in thousands)

 

2017

 

2016

 

Change

 

Three Months Ended March 31, 

Increase/(Decrease)

(dollars in thousands)

    

2022

    

2021

    

Personnel-related

    

$

729

    

$

640

    

$

89

 

$

1,994

$

1,605

$

389

24

%

Stock-based compensation

 

635

 

479

 

156

 

 

762

 

925

 

(163)

(18)

%

Legal, consulting and other professional expenses

 

863

 

719

 

144

 

 

2,105

 

1,468

 

637

43

%

Other

 

 

175

 

 

146

 

 

29

 

 

195

 

190

 

5

3

%

General and administrative expense

 

$

2,402

 

$

1,984

 

$

418

 

$

5,056

$

4,188

$

868

21

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 $868,000 for the three months ended March 31, 2022 as compared to the same period in 2021. The increase was primarily due to commercial start-up expenses for uproleselan and higher patent fees in the first quarter of 2022 as compared to 2021. Personnel-related costs increased due to our hiring of a Chief Commercial Officer in February 2022.


Interest Income

During the three months ended September 30, 2017, our general and administrative expenseMarch 31, 2022 interest income increased by $418,000slightly due to higher interest rates in the first quarter of 2022 as compared to the same period in 2016, reflecting an increase2021.

24

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, our at-the-marketincluding sales facilitiesagreements with Cowen, our public offerings in June 2016 and May 2017 and upfront and milestone payments from Pfizer.our license and collaboration agreements. As of September 30, 2017,March 31, 2022, we had $112.9$76.5 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 October 2020, we entered into an at-the-market sales agreement, or the 2020 Sales Agreement, with Cowen to sellCowen. During the year ended December 31, 2020, we sold 1,024,760 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 sold an aggregate of 1,388,647 shares of our common stock under the at-the-market facility,2020 Sales Agreement at a weighted average price of $3.74 per share, for aggregate net proceeds of $7.4 million. We$3.7 million, after deducting commissions and Cowen terminatedoffering expenses. During the agreement in May 2017. As of its termination ,year ended December 31, 2021, we had sold an aggregateadditional 3,092,603 shares of 2,057,438 sharescommon stock under the 2020 Sales Agreement at a weighted average price of $3.57 per share, for aggregate net proceeds of $11.3$10.7 million, after deducting commissions and offering expenses. As of December 31, 2021, there was $85.1 million remaining available to be sold under the at-the-market facility.terms of the 2020 Sales Agreement, and subsequent to December 31, 2021 we did not make any additional sales under the 2020 Sales Agreement.

In May 2017,March 2022, we completedfiled a public offering inshelf registration statement with the SEC, which was declared effective on April 22, 2022. On April 28, 2022, we sold 8,050,000 shares of our common stock at a price toterminated 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 whichCowen. Under the 2022 Sales Agreement, we may offer and sell from time to time at our sole discretion, 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 the date of this report, we have sold an aggregate of 1,600,000 shares of our common stockstock.

We entered into a collaboration and license agreement with Apollomics in January 2020 and are potentially eligible to earn milestone payments and royalties under that agreement. In January 2020, Apollomics made an upfront payment to us of $9.0 million. We also received a non-refundable payment of $1.0 million in September 2020 as a clinical development milestone payment. Our ability to earn additional milestone payments and potential royalty payments and their timing will be dependent upon the new at-the-market facility, for net proceedsoutcome of $19.2 million.Apollomics’ 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.

As of March 31, 2022, our significant contractual obligations consisted solely of rent obligations under a non-cancelable lease, as amended, for our current office space in Rockville, Maryland, which has a term through October 2023. Total remaining obligations under this lease as of March 31, 2022 were $1.7 million. We have no other fixed long-term obligations and we do not have significant capital expenditure requirements.

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-1271and potential commercialization of uproleselan or our other drug candidates. We are also unable to predict when, if ever, material net cash inflows will commence from rivipanseluproleselan 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;

24


·

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

25

·

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 collaborationlicense agreement with Pfizer.Apollomics. Except for Pfizer’s obligationApollomics’ conditional obligations to make milestone and royalty payments to us under our 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.

OutlookGoing Concern

The accompanying financial statements included in this report have been prepared assuming that we will continue as a going concern within one year after the date that the financial statements are issued. During 2021, we incurred a net loss of $63.4 million and had net cash flows used in operating activities of $57.5 million. At March 31, 2022, we had $76.5 million in cash and cash equivalents and had no committed source of additional funding from either debt or equity financings, although we may, in our discretion, sell equity securities under the 2022 Sales Agreement described above, subject to certain conditions and limitations. Management believes that given our current cash position and forecasted negative cash flows from operating activities over the next twelve months as we continue our product development activities, including the completion of our planned Phase 3 clinical trial of uproleselan, there is substantial doubt about our ability to continue as a going concern beyond the date that is one year from the date that the financial statements included in this report are issued, without obtaining additional financing or entering into another form of non-equity or debt arrangement.

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 throughinto the second halfthird quarter of 2019.2023. 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.

26

Cash Flows

The following is a summary of our cash flows for the ninethree months ended September 30, 2017March 31, 2022 and 2016:2021:

 

 

 

 

 

 

 

 

Nine Months Ended  September 30, 

 

Three Months Ended March 31, 

(in thousands)

 

2017

 

2016

 

2022

2021

Net cash provided by (used in):

    

 

 

    

 

 

 

    

    

Operating activities

 

$

(21,399)

 

$

(23,777)

 

$

(13,698)

$

(14,125)

Investing activities

 

 

(260)

 

 

(266)

 

 

(41)

 

(3)

Financing activities

 

 

94,490

 

 

22,522

 

 

 

9,564

Net change in cash and cash equivalents

 

$

72,831

 

$

(1,521)

 

$

(13,739)

$

(4,564)

Operating Activities

Net cash used in operating activities for the ninethree months ended September 30, 2017 includedMarch 31, 2022 and 2021 was primarily the result of ongoing clinical and manufacturing costs associated with the GMI-1271our uproleselan clinical development programs. NetThese cash used in operating activitiesexpenses were offset by non-cash expenses for stock-based compensation, lease expense and depreciation, and for the ninethree months ended September 30, 2016 includedMarch 31, 2021, the costs associated with the advancementclinical supplies payment of the GMI-1271 and GMI-1359 development programs. In addition, the $2.0$1.0 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.received from Apollomics.

25


Investing Activities

Net cash used in investing activities for the ninethree months ended September 30, 2017 included capital expenses relating to the additional leasehold improvementsMarch 31, 2022 and the purchase of2021 was for computer, office 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 architectequipment and project management fees.was immaterial.

Financing Activities

Net cash provided byThere were no financing activities for the ninethree 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.March 31, 2022. Net cash provided by financing activities during the ninethree months ended September 30, 2016 comprisedMarch 31, 2021 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 salescommon stock under our sales agreementat-the-market facility with Cowen.Cowen of $9.6 million.

Off-Balance Sheet Arrangements

During the nine months ended September 30, 2017, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

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

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, 2017March 31, 2022 and December 31, 2016,2021, we had cash and cash equivalents of $112.9$76.5 million and $40.0$90.3 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’sSEC’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.

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

26


controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit

27

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, 2022, 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, 2017March 31, 2022 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‑Q10-Q have not changed materially from those described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10‑K10-K for the fiscal year ended December 31, 2016,2021, filed with the Securities and Exchange CommissionSEC on March 1, 2017.3, 2022.

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

On April 28, 2022, we entered into the 2022 Sales Agreement with Cowen under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100,000,000, or the ATM Shares, after the date of the 2022 Sales Agreement through Cowen as our sales agent. The 2022 Sales Agreement replaces the 2020 Sales Agreement between us and Cowen, which has been terminated. We sold an aggregate of $14.9 million in shares of common stock under the 2020 Sales Agreement.

The ATM Shares will be offered and sold pursuant to our Registration Statement on Form S-3 (File No. 333-263297), which was declared effective by the SEC on April 22, 2022. We will file a prospectus supplement with the SEC in connection with the offer and sale of the ATM Shares pursuant to the 2022 Sales Agreement.

Cowen may sell the ATM Shares under the 2022 Sales Agreement by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including without limitation sales made by means of ordinary brokers’ transactions on The Nasdaq Global Market or otherwise at market prices prevailing at the time of sale, in block transactions, or as otherwise directed by us. Cowen will use commercially reasonable efforts to sell the ATM Shares from time to time, based upon instructions from us (including any price, time or size limits or other customary parameters or conditions we may impose). We will pay Cowen a commission equal to

27

28


three percent (3.0%) of the gross sales proceeds of any ATM Shares sold through Cowen under the 2022 Sales Agreement, and also have provided Cowen with customary indemnification rights. In addition, we have agreed to reimburse certain legal expenses and fees by Cowen in connection with the offering up to a maximum of $50,000.

We are not obligated to make any sales of ATM Shares under the 2022 Sales Agreement. The offering of ATM Shares pursuant to the 2022 Sales Agreement will terminate upon the earlier of (i) the sale of all ATM Shares subject to the 2022 Sales Agreement or (ii) termination of the 2022 Sales Agreement in accordance with its terms.

The foregoing description of the 2022 Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the 2022 Sales Agreement, a copy of which is filed as Exhibit 10.1 to this Quarterly Report on Form 10-Q.

The legal opinion of Cooley LLP relating to the validity of the ATM Shares being offered pursuant to the 2022 Sales Agreement is filed as Exhibit 5.1 to this Quarterly Report on Form 10-Q.

This Quarterly Report on Form 10-Q shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

29

Item

ITEM 6.       ExhibitsEXHIBITS

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‑K8-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‑K8-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‑1S-1 (File No. 333‑191567)333-191567), filed with the Commission on October 31, 2013).

5.1*

Opinion of Cooley LLP.

10.1*

Sales Agreement, dated April 28, 2022, by and between the Company and Cowen and Company, LLC.

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)


*     Filed herewithherewith.

**   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.

28

30


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, 2017April 28, 2022

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)

29

31