GLYCOMIMETICS INC
For the period ended Dec 31, 2023. Filed Mar 27, 2024.
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FY2023 · Filed Mar 27, 2024
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Notes to Financial Statements
1. Description of the Business
GlycoMimetics, Inc. (the Company), a Delaware corporation headquartered in Rockville, Maryland, was incorporated in 2003. The Company is a late clinical-stage biotechnology company focused on improving the lives of people living with cancer and inflammatory diseases by leveraging the inhibition of carbohydrate interactions that occur on the surface of cells. The Company is developing a pipeline of proprietary glycomimetics, which are small molecules that mimic the structure of carbohydrates involved in important biological processes, to inhibit disease-related functions of carbohydrates such as the roles they play in cancers and inflammation.
2. Going Concern
The accompanying 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 2023, the Company incurred a net loss of $36.9 million and had net cash flows used in operating activities of $34.9 million. At December 31, 2023, the Company had $41.8 million in cash and cash equivalents and had no committed source of additional funding from either debt or equity financings. 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 financial statements are issued, without obtaining additional financing or entering into another form of non-equity or debt arrangement.
The Company’s ability to fund its operations is dependent upon management’s plans, which include raising additional capital in the near term primarily through a combination of equity and debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements and in the longer term, from revenue related to product sales, to the extent 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 on commercially acceptable terms, or at all. Also, any collaborations, strategic alliances and marketing, distribution or licensing arrangements may require the Company to give up some or all of its rights to a product or technology, which in some cases may be at less than the full potential value of such rights. If the Company is unable to obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of or eliminate some or all of its operations, which may have a material adverse effect on its business, financial condition, results of operations and ability to operate as a going concern.
The financial statements do not include any adjustments that might be necessary if the Company is not able to continue as a going concern.
3. Summary of Significant Accounting Policies
Basis of Accounting
The accompanying financial statements were prepared based on the accrual method of accounting in accordance with U.S. generally accepted accounting principles (GAAP).
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business inone segment, which is the identification and development of glycomimetic compounds.
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.
Cash and Cash Equivalents
Cash and cash equivalents consist of investment in money market funds with commercial banks and financial institutions. The Company considers all investments in highly liquid financial instruments with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash equivalents are stated at amortized cost, plus accrued interest, which approximates fair value.
Fair Value Measurements
The Company’s financial instruments include cash and cash equivalents. The fair values of the financial instruments approximated their carrying values at December 31, 2023 and 2022, due to their short-term maturities. The Company accounts for recurring and nonrecurring fair value measurements in accordance with ASC 820,Fair Value Measurements. ASC 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value, and requires expanded disclosures about fair value measurements. The ASC hierarchy ranks the quality of reliability of inputs, or assumptions, used in the determination of fair value, and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories:
| ● | Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. |
| ● | Level 2—Fair value is determined by using inputs, other than Level 1 quoted prices, that are directly and indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models that can be corroborated by observable market data. |
| ● | Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity. In instances where the determination of the fair value measurement is based on inputs from different levels of fair value hierarchy, the fair value measurement will fall within the lowest level input that is significant to the fair value measurement in its entirety. |
The Company periodically evaluates financial assets and liabilities subject to fair value measurements to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC 820 hierarchy.
The Company hadno 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) either on a recurring or non-recurring basis as of December 31, 2023 and 2022. The carrying value of cash held in money market funds of approximately $38.8 million and $45.9 million as of December 31, 2023 and 2022, respectively, is included in cash and cash equivalents and approximates market values based on quoted market prices (Level 1 inputs). The Company did not transfer any assets measured at fair value on a recurring basis between levels during the years ended December 31, 2023 and 2022.
Concentration of Credit Risk
Credit risk represents the risk that the Company would incur a loss if counterparties failed to perform pursuant to the terms of their agreements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains its cash balances with financial institutions in federally insured accounts and has cash balances in excess of the insurance limits. Cash equivalents consist of investment in United States government money market funds with major financial institutions. These deposits and funds may be redeemed upon demand and the Company does not anticipate any losses on such balances. The Company has not experienced any losses to date and believes that it is not exposed to any significant credit risk on cash and cash equivalents.
Impairment of Long-Lived Assets
The Company periodically assesses the recoverability of the carrying value of its long-lived assets in accordance with the provisions of ASC 360,Property, Plant, and Equipment. ASC 360 requires that long-lived assets and certain
identifiable intangible assets be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If the carrying value exceeds the sum of undiscounted cash flows, the Company then determines the fair value of the underlying asset. Any impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less costs to sell. As of December 31, 2023 and 2022, the Company determined that there wereno impaired assets and it hadno assets held for sale.
Revenue Recognition
The Company applies Accounting Standards Codification, or ASC, Topic 606,Revenue from Contracts with Customers(Topic 606), to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods and services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with the customer(s); (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of 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 fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product, if and when earned. See Note 11 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 require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success.
*Licensing of Intellectual Property:*If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the
overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration and other revenues and earnings in their period of adjustment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements.
*Manufacturing and Supply:*The obligations under the Company’s agreements may include clinical and 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. 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.
Research and Development Costs
Except for payments made in advance of services, research and development costs are expensed 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 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.
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 outsources a significant portion of these clinical trial activities to third parties. The accrual for site and patient costs includes inputs such as estimates of patient enrollment, patient cycles incurred, clinical site close-out activities, estimated project duration and other pass-through costs. These inputs are required to be estimated due to a lag in receiving the actual clinical information from third parties. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the balance sheets as a prepaid asset or accrued expenses. These third-party agreements are generally cancellable, and related costs are recorded as research and development expenses as incurred. Except for payments made in advance of services, clinical trial costs are expensed as incurred. Non-refundable advance clinical payments for goods or services that will be used or rendered for future research and development activities are recorded as a prepaid asset and recognized as expense as the related goods are delivered or the related services are performed. When evaluating the adequacy of the accrued expenses, management 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. Significant judgments and estimates may be made in determining the accrued balances at the end of any 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.
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 has elected to account 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. The Company bases the expected volatility on the historical volatility of the Company’s 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.
Income Taxes
The Company accounts for income taxes using the asset and liability method in accordance with ASC 740,* Income Taxes*. Deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and the financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized.
The Company accounts for uncertain tax positions pursuant to ASC 740. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that tax position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.
Comprehensive Loss
Comprehensive loss comprises net loss and other changes in equity that are excluded from net loss. For the years ended December 31, 2023, 2022 and 2021, the Company’s net loss was equal to comprehensive loss and, accordingly, no additional disclosure is presented.
Recently Issued Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024 and early adoption is permitted. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s consolidated financial statements.
4. Net Loss Per Share of Common Stock
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 (RSUs).
The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average common shares outstanding, as they would be anti-dilutive:
| · · · · · · | |||
|---|---|---|---|
| · · · · · · | |||
| | 2023 | 2022 | 2021 |
| Stock options and RSUs | 10,981,357 | 9,313,102 | 7,908,122 |
5. Prepaid Expenses and Other Current Assets
The following is a summary of the Company’s prepaid expenses and other current assets at December 31:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · · · · | |||||||
| · 2023 · 2022 | |||||||
| Prepaid research and development expenses | | | $1,420,642 | | $2,300,209 | ||
| Other prepaid expenses | | | | 401,442 | | | 399,861 |
| Other receivables | | | 175,820 | | 144,016 | ||
| Prepaid expenses and other current assets | | | $1,997,904 | | $2,844,086 | ||
6. Accrued Expenses
The following is a summary of the Company’s accrued expenses at December 31:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · · | ||||||
| · · 2023 · · 2022 | ||||||
| Accrued research and development expenses | | $1,824,689 | | $3,484,742 | ||
| Accrued bonuses | | | 2,561,913 | | | 2,664,613 |
| Accrued consulting and other professional fees | | 439,192 | | 499,592 | ||
| Accrued employee benefits | | 399,763 | | 300,653 | ||
| Other accrued expenses | | — | | 42,406 | ||
| Accrued expenses | | $5,225,557 | | $6,992,006 | ||
7. Operating Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company determines a lease exists if the contract conveys the right to control an identified asset for a period of time in exchange for consideration. Control is considered to exist when the lessee has the 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. The Company has also elected to use the practical expedient and account for each lease component and related non-lease component as onesingle component. The lease component results in a right-of-use asset being recorded on the balance sheet and amortized as lease expense on a straight-line basis.
The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a term similar to the term of the lease for which the rate is estimated. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.
The Company leases office and research space in Rockville, Maryland under an operating lease that is subject to annual rent increases (the Lease). The Company paid a security deposit of $52,320 to be held until the expiration or
termination of the Company’s obligations under the Lease. In April 2023, the Company and its landlord entered into an amendment to the Lease (the Lease Amendment). Pursuant to the Lease Amendment, the Company and the landlord agreed that the lease term for a portion of the premises consisting of approximately 30,000 square feet, would beextended from November 1, 2023 to January 31, 2025. The Company’s lease of the remaining premises, consisting of approximately 12,000 square feet expired on October 31, 2023. There wereno additional operating leases entered into during the year ended December 31, 2023.
The components of lease expense and related cash flows were as follows:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| | Year Ended December 31, | |||||||
| · 2023 · 2022 · · 2021 | ||||||||
| Operating lease cost | $944,963 | | $927,957 | | $927,957 | |||
| Variable lease cost | | 602,416 | | | 612,391 | | | 490,871 |
| Total operating lease cost | $1,547,379 | | $1,540,348 | | $1,418,828 | |||
| | | | | | | | | |
| Cash paid for amounts included in the measurement of lease liabilities: | | | | | | | | |
| Operating cash outflows for operating leases | $1,017,770 | | $1,104,406 | | $1,077,469 | |||
Maturities of lease liability due under these lease agreements as of December 31, 2023 were as follows:
| | | | |
|---|---|---|---|
| · · Operating Lease | |||
| · Obligation | |||
| 2024 | | $789,183 | |
| 2025 | | | 67,401 |
| Thereafter | | | — |
| Total | | | 856,584 |
| Present value adjustment | | | (48,182) |
| Present value of lease payments | | $808,402 | |
Supplemental information related to leases were as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · December 31, · · December 31, | ||||||
| Operating Leases · · 2023 · · 2022 | ||||||
| Weighted-average remaining lease term (in years) | | | 1.1 | | | 0.8 |
| Weighted-average incremental borrowing rate | | | 10.0% | | | 8.0% |
| · · · · · | ||||
|---|---|---|---|---|
| | Year Ended December 31, | |||
| · 2023 · 2022 | ||||
| Right-of-use assets obtained in exchange for operating lease obligations | $872,892 | | $ | - |
8. Stockholders’ Equity
Common Stock
At-The-Market Equity Offerings
On October 7, 2020, the Company filed a prospectus supplement to a shelf registration statement that it filed in May 2019 and entered into an at-the-market sales agreement (the 2020 Sales Agreement) with Cowen and Company, LLC (Cowen) in. Under the 2020 Sales Agreement, the Company could sell up to $100.0 million of the Company’s common stock registered under the shelf registration statement that was filed in May 2019. During the year ended December 31, 2021, the Company issued and sold 3,092,603 shares of common stock under the 2020 Sales Agreement at a weighted average price per share of $3.57, for aggregate net proceeds of $10.7 million, after deducting commissions and offering expenses. There wereno shares sold under the 2020 Sales Agreement in the year ended December 31, 2022.
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 previously entered into with Cowen in 2020 and entered into a new at-the-market sales agreement (the 2022 Sales Agreement) with Cowen. Under
the 2022 Sales Agreement, the Company may sell up to $100.0 million worth of shares of common stock. During the year ended December 31, 2022, the Company issued and sold 1,953,854 shares of common stock under the 2022 Sales Agreement at a weighted average price per share of $2.22, for aggregate net proceeds of $4.2 million, after deducting commissions and offering expenses.
During the year ended December 31, 2023, the Company issued and sold 9,822,930 shares of common stock under the 2022 Sales Agreement at a weighted average price per share of $3.01, for aggregate net proceeds of $28.7 million, after deducting commissions and offering expenses. As of December 31, 2023, approximately $66.0 million remained available to be sold under the terms of the 2022 Sales Agreement.
9. Stock-based Compensation
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 oneforty-eighth of the option shares per month as of the first day of each month after the first anniversary. Compensation expense for awards under the 2003 Plan was recognized on a straight-line basis. Upon termination of employment by reasons other than death, cause, or disability, any vested options granted under the 2003 Plan terminated 60 days after the termination date. Stock options terminated 10 years from the date of grant. The 2003 Plan expired on May 21, 2013. There were no options outstanding under the 2003 Plan as of December 31, 2023.
During 2021, the Company issued 3,785 shares of common stock in conjunction with exercises of stock options granted under the 2003 Plan and received $4,239 in cash proceeds from the exercise of these stock options. Total intrinsic value of the options exercised during the year ended December 31, 2021 was $8,668. There wereno options exercised under the 2003 Plan in 2023 and 2022.
2013 Equity Incentive Plan
The Company’s board of directors adopted, and its stockholders approved, its 2013 Equity Incentive Plan effective in January 2014, and the 2013 Equity Incentive Plan was amended and restated by approval of the board of directors in April 2022 and by approval of the stockholders in May 2022 (as so amended and restated, the 2013 Plan). The 2013 Plan provides for the grant of incentive stock options within the meaning of Section 422 of the Internal Revenue Code (the Code), to the Company’s employees and its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock awards, restricted stock unit 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 at the rate of oneforty-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 90 days after the termination date, unless otherwise set forth in a stock option agreement. Stock options generally terminate 10 years from the date of grant.
Authorized Shares
The maximum number of shares of common stock that may be issued under the 2013 Plan was originally 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. Upon the amendment and restatement of the 2013 Plan in May 2022, the existing share reserve was increased by 2,619,622. 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 2013 Plan will cumulatively be increased by 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or such lesser number of shares as determined by the board of 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. As of December 31, 2023, the total number of
shares reserved for issuance under the 2013 Plan was 11,681,878 shares, of which 2,531,613 shares were available for future grants.
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 award or to satisfy tax withholding obligations related to a stock award, will become available for future grant under the 2013 Plan.
Stock Options
A summary of the Company’s stock option activity under the 2013 Plan for the year ended December 31, 2023 is as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · WEIGHTED- · · AGGREGATE | ||||||||||
| · · · WEIGHTED- · · AVERAGE · · INTRINSIC | ||||||||||
| · · · AVERAGE · · REMAINING · · VALUE | ||||||||||
| · OUTSTANDING · · EXERCISE · · CONTRACTUAL · · (IN | ||||||||||
| · OPTIONS · PRICE · TERM (YEARS) · THOUSANDS) | ||||||||||
| Outstanding as of December 31, 2022 | | 6,774,792 | | $6.37 | | 6.1 | | | | |
| Options granted | | 2,496,850 | | | 2.52 | | | | | |
| Options exercised | | (100,960) | | | 1.15 | | | | | |
| Options forfeited | | (896,882) | | | 6.16 | | | | | |
| Outstanding as of December 31, 2023 | | 8,273,800 | | | 5.29 | | 6.3 | | $2,043 | |
| Vested or expected to vest as of December 31, 2023 | | 8,131,900 | | | 5.37 | | 6.3 | | | 1,865 |
| Exercisable as of December 31, 2023 | | 4,993,061 | | | 7.30 | | 4.5 | | | 921 |
As of December 31, 2023, there was $4,200,069 of total unrecognized compensation expense related to unvested options that will be recognized over a weighted-average period of approximately 2.7 years. The total fair value of options that vested in the years ended December 31, 2023, 2022 and 2021 was $1,710,938, $3,306,412 and $5,936,641, respectively. During 2023, the Company issued 100,960 shares of common stock in conjunction with exercises of stock options granted under the 2013 Plan and received $116,497 in cash proceeds from the exercise of these stock options. Total intrinsic value of the options exercised during the year ended December 31, 2023 was $82,300. There wereno options exercised under the 2013 Plan during the years ended December 31, 2022 and 2021.
The Company has granted stock options to purchase an aggregate of 141,900 shares to certain employees under the 2013 Plan that are subject to performance vesting conditions. The shares will vest upon achievement of milestones as follows: (i)one-half of the shares will vest upon FDA approval of uproleselan for patients with relapsed/refractory acute myeloid leukemia and (ii)one-half of the shares will vest upon the first commercial sale of uproleselan in the United States or abroad. The maximum fair value of $113,520 associated with the performance-based options granted in January 2022 is excluded from the unrecognized compensation expense under the 2013 Plan as the achievement of the performance milestones was not deemed to be probable as of December 31, 2023. The Company will reevaluate at the end of each reporting period the probability that the performance conditions will be achieved and will record any adjustments to the compensation cost at that time.
Restricted Stock Units (RSUs)
A restricted stock unit (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 RSUs granted vest over four years in equal installments on each anniversary of the grant date. Compensation expense is recognized on a straight-line basis. As of December 31, 2023, there was $235,269 of total unrecognized compensation expense associated with these RSU grants that will be recognized over a weighted-average period of approximately 1.1 years.
The following is a summary of RSU activity for the 2013 Plan for the year ended December 31, 2023:
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · · Weighted-Average | |||||
| · · Number of Shares · · Grant Date | |||||
| · · Underlying RSUs · Fair Value | |||||
| Unvested at December 31, 2022 | | 204,785 | | $3.81 | |
| Forfeited | | (19,573) | | 3.81 | |
| Vested | | (68,055) | | 3.81 | |
| Unvested at December 31, 2023 | | 117,157 | | 3.81 | |
Issuance of Shares to Directors in Lieu of Cash Compensation
In March 2023, the Company’s board of directors amended the Company’s Non-Employee Director Compensation Policy to include an election to receive unrestricted shares of common stock in lieu of quarterly board and committee retainer cash payments. The number of shares to be issued to an electing director is determined on the last day of each fiscal quarter by dividing the dollar amount of the compensation to be paid for such quarter that is subject to the election by the closing price of a share of common stock on the last trading day of the fiscal quarter, rounded up to the nearest whole share. Non-employee directors will receive 39,527 shares of common stock in lieu of cash compensation earned for the year ended December 31, 2023. All shares of common stock issued pursuant to such an election are fully vested upon issuance and are classified as “Other Awards” under the 2013 Plan.
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, restricted stock unit 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 ofthirty-six successive equal monthly installments as of the first day of each month measured from the first anniversary of the vesting start date, subject to the new employee’s continued service with the Company through the applicable vesting dates. Upon termination of employment by reasons other than death, cause or disability, any vested options will terminate 90 days after the termination date, unless otherwise set forth in a stock option agreement. Stock options generally terminate 10 years from the date of grant. 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. As of December 31, 2023, there were 399,508 shares available for future grants under the Inducement Plan.
A summary of the Company’s stock option activity under the Inducement Plan for the year ended December 31, 2023 is as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · WEIGHTED- · · AGGREGATE | ||||||||||
| · · · WEIGHTED- · · AVERAGE · · INTRINSIC | ||||||||||
| · · · AVERAGE · · REMAINING · · VALUE | ||||||||||
| · OUTSTANDING · · EXERCISE · · CONTRACTUAL · · (IN | ||||||||||
| · OPTIONS · PRICE · TERM (YEARS) · THOUSANDS) | ||||||||||
| Outstanding as of December 31, 2022 | | 2,333,525 | | $1.82 | | 8.7 | | | | |
| Options granted | | 360,000 | | | 2.76 | | | | | |
| Options forfeited | | (103,125) | | | 1.34 | | | | | |
| Outstanding as of December 31, 2023 | | 2,590,400 | | | 1.97 | | 8.0 | | $1,304 | |
| Vested or expected to vest as of December 31, 2023 | | 2,006,200 | | | 1.96 | | 8.0 | | | 1,077 |
| Exercisable as of December 31, 2023 | | 887,696 | | | 1.90 | | 7.7 | | | 460 |
As of December 31, 2023, there was $1,485,094 of total unrecognized compensation expense related to unvested options under the Inducement Plan that will be recognized over a weighted-average period of approximately 2.4 years. The total fair value of options that vested in the years ended December 31, 2023, 2022 and 2021 was $601,586, $604,440
and $73,334, respectively. During the year ended December 31, 2021, the Company received cash of $20,790 and issued 10,092 shares of common stock in conjunction with exercises of stock options granted under the Inducement Plan. The intrinsic value of the options exercised for the year ended December 31, 2021 was $1,944. There wereno options exercised under the Inducement Plan during the years ended December 31, 2023 or 2022.
During the years ended December 31, 2022 and 2021, the Company granted stock options to purchase an aggregate of 584,200 shares to certain newly hired employees under the Inducement Plan, which options were subject to the same performance vesting conditions described above with respect to the stock options granted in January 2022 under the 2013 Plan. The maximum fair value of $825,353 associated with the performance-based options is excluded from the unrecognized compensation expense under the Inducement Plan as the achievement of the performance milestones was not deemed to be probable as of December 31, 2023. The Company will reevaluate at the end of each reporting period the probability that the performance conditions will be achieved and will record any adjustments to the compensation cost at that time.
The weighted-average fair value of the options granted under all equity incentive plans during the years ended December 31, 2023, 2022 and 2021 was $1.96, $0.76 and $1.85 per share, respectively, applying the Black-Scholes-Merton option pricing model utilizing the following weighted-average assumptions:
| · · · · · · | |||||
|---|---|---|---|---|---|
| | 2023 | | 2022 | | 2021 |
| Expected term | 6.25 years | | 6.25 years | | 6.25 years |
| Expected volatility | 78.36% | | 84.66% | | 84.19% |
| Risk-free interest rate | 3.60% | | 1.90% | | 0.78% |
| Expected dividend yield | 0% | | 0% | | 0% |
Total stock-based compensation expense associated with stock options and RSUs was classified as follows on the statement of operations for the years ended December 31:
| · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| | | | | | | | |
| · 2023 · 2022 · 2021 | |||||||
| Research and development expense | | | $909,981 | | $1,059,591 | | $2,214,848 |
| General and administrative expense | | | 2,614,495 | | 2,797,989 | | 3,872,438 |
| Total stock-based compensation expense | | | $3,524,476 | | $3,857,580 | | $6,087,286 |
10. Income Taxes
The components of the gross deferred tax asset and related valuation allowance at December 31 were as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · 2023 · 2022 | |||||||
| Deferred income tax assets: | | | | | | | |
| Net operating loss carryforward | | $88,746,869 | | $82,784,742 | | ||
| Research and orphan drug credits | | 53,152,849 | | 51,184,585 | | ||
| Capitalized research costs | | 10,748,355 | | 7,125,276 | | ||
| Capitalized start-up costs | | 532,931 | | 726,724 | | ||
| Patent amortization | | 42,541 | | 58,010 | | ||
| Stock-based compensation | | 7,324,617 | | 7,247,715 | | ||
| Accrued bonus | | | 704,974 | | | 733,235 | |
| Operating lease liabilities | | | 222,452 | | | 252,777 | |
| Other | | | 87,097 | | | 210,237 | |
| Gross deferred income tax assets | | 161,562,685 | | 150,323,301 | | ||
| Valuation allowance | | (161,351,398) | | (149,972,514) | | ||
| Net deferred income tax assets | | 211,287 | | 350,787 | | ||
| | | | | | | | |
| Deferred income tax liabilities: | | | | | | | |
| Operating lease right-of-use assets | | (211,287) | | (206,704) | | ||
| Property and equipment | | — | | (144,083) | | ||
| Gross deferred income tax liabilities | | (211,287) | | (350,787) | | ||
| Net deferred income tax asset/(liability) | | $— | | $— | | ||
Based on the Company’s operating history and management’s expectation regarding future profitability, management believes the Company’s deferred tax assets will not be realizable under ASC 740,Income Taxes. Accordingly, a full valuation allowance was established as of December 31, 2023 and 2022.
Effective for tax years beginning on or after January 1, 2022, pursuant to the Tax Cuts and Jobs Act of 2017, companies are required to capitalize and amortize Internal Revenue Code Section 174 research and experimental expenses paid or incurred over 5 years for research and development performed in the United States and 15 years for research and development performed outside of the United States. As a result of the Internal Revenue Code Section 174 research and experimental expense capitalization, the Company recognized a deferred tax asset for the future tax benefit of the amortization deductions with an offsetting increase in the valuation allowance on deferred tax assets.
As of December 31, 2023, the Company had $322.5 million of U.S. Federal and state net operating losses, $10.9 million of research and development tax credits and $42.3 million of orphan drug tax credits available to carry forward. A portion of the net operating loss carryforwards will begin to expire in 2026, the research and development tax credits in 2024 and the orphan drug tax credit in 2033. Under current federal income tax laws, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited.
The Company’s tax attributes, including net operating losses and credits, are subject to any ownership changes as defined under Internal Revenue Code Sections 382 and 383. A change in ownership could affect the Company’s ability to utilize its net operating losses and credits. As of December 31, 2023, the Company does not believe that an ownership change has occurred. Any future ownership changes may cause a limitation on the Company’s ability to utilize existing tax attributes.
The Company files income tax returns in the U.S. federal jurisdiction and in the State of Maryland. The Company’s federal income tax returns for tax years 2004 and after remain subject to examination by the U.S. Internal Revenue Service due to tax attributes available to be carried forward to open or future tax years. The Company’s Maryland income tax returns for the tax years 2006 and thereafter remain subject to examination by the Comptroller of
Maryland. In addition, all of the net operating losses, research and development tax credit and orphan drug credit carryforwards that may be used in future years are still subject to adjustment.
The Company did not have unrecognized tax benefits as of December 31, 2023 and 2022, and does not anticipate this to change significantly over the next 12 months. The Company will recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. Reconciliations between the statutory federal income tax rate and the effective income tax rate of income tax expense is as follows as of December 31:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · 2023 · 2022 · 2021 | |||||||
| U.S. Federal statutory tax rate | 21.0% | 21.0% | 21.0% | ||||
| State taxes | 6.3 | 6.1 | 5.9 | | |||
| Research credit | 0.7 | 0.6 | 0.9 | | |||
| Orphan drug credit | 4.1 | 4.8 | 6.6 | | |||
| Other | | (1.3) | | (3.9) | | (0.3) | |
| Change in valuation allowance | (30.8) | (28.6) | (34.1) | | |||
| Provision for income taxes | —% | —% | —% | ||||
11. Research and License Agreements
Apollomics
In 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 Apollomics entered into a clinical supply agreement pursuant to which the 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 year ended December 30, 2021, the Company recognized $1.1 million as revenue from the sale of clinical supplies to Apollomics. There wereno sales of clinical supplies under the Agreement for the years ended December 31, 2023 or 2022.
The Company evaluated the Agreement under the provisions of ASC 606 and identified two performance obligations under this revenue arrangement: the (i) delivery of functional licenses and (ii) manufacture and supply of the Products. The initial transaction price consisted 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 and regulatory events, (ii) up to $105.0 million of sales-based commercial milestones based on achievement of certain annual net sales targets, (iii) sales-based royalties at specified percentages of net sales ranging from the high single digits to 15%, and (iv) manufacture and supply of clinical and commercial Products. The Company has fully constrained the development milestone consideration using the most likely amount method and will recognize that revenue when it is probable that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. The Company did not recognize any milestone revenue under the Agreement for the years ended December 31, 2023, 2022 or 2021.
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 (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.
12. Employee Benefit Plan
The Company has a defined contribution plan under the Internal Revenue Code Section 401(k). This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. For the years ended December 31, 2023, 2022 and 2021, the Company matched 50% up to the first 6% of employee contributions. All matching contributions have been paid by the Company. The Company’s matching contributions vest in full immediately. The total Company matching contributions were approximately $248,000, $254,000 and $270,000 for the years ended December 31, 2023, 2022 and 2021, respectively.
13. Subsequent Events
In January 2024, the Company entered into a project agreement for the manufacture and supply of injectable uproleselan from active pharmaceutical ingredient for commercial sale should the Company receive marketing approval from the FDA. The initial term of the agreement is through year end 2026 with automatic 3-year renewal periods unless otherwise terminated by either party.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.