Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 01, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Entity File Number | 001-36177 | |
Entity Registrant Name | GlycoMimetics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 06-1686563 | |
Entity Address, Address Line One | 9708 Medical Center Drive | |
Entity Address, City or Town | Rockville | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20850 | |
City Area Code | 240 | |
Local Phone Number | 243-1201 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | GLYC | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 64,393,294 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001253689 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 49,407,629 | $ 47,870,619 |
Prepaid expenses and other current assets | 2,602,446 | 2,844,086 |
Total current assets | 52,010,075 | 50,714,705 |
Property and equipment, net | 132,979 | 242,390 |
Prepaid research and development expenses | 50,000 | 50,000 |
Deposits | 52,320 | 52,320 |
Operating lease right-of-use asset | 955,310 | 751,174 |
Total assets | 53,200,684 | 51,810,589 |
Current liabilities: | ||
Accounts payable | 329,885 | 970,191 |
Accrued expenses | 5,311,377 | 6,992,006 |
Lease liabilities | 749,618 | 918,555 |
Total current liabilities | 6,390,880 | 8,880,752 |
Lease liabilities, net of current portion | 262,133 | |
Total liabilities | 6,653,013 | 8,880,752 |
Stockholders' equity: | ||
Preferred stock; $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding at June 30, 2023 and December 31, 2022 | ||
Common stock; $0.001 par value; 100,000,000 shares authorized; 64,313,333 shares issued and outstanding at June 30, 2023; 54,377,798 shares issued and outstanding at December 31, 2022 | 64,369 | 54,378 |
Additional paid-in capital | 493,889,874 | 462,461,251 |
Accumulated deficit | (447,406,572) | (419,585,792) |
Total stockholders' equity | 46,547,671 | 42,929,837 |
Total liabilities and stockholders' equity | $ 53,200,684 | $ 51,810,589 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheets | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 64,368,843 | 54,377,798 |
Common stock, shares outstanding | 64,368,843 | 54,377,798 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statements of Operations and Comprehensive Loss | ||||
Revenue from collaboration and license agreements | $ 75,000 | |||
Costs and expenses: | ||||
Research and development expense | $ 5,291,790 | $ 4,922,857 | $ 14,783,204 | 22,500,058 |
General and administrative expense | 4,521,706 | 3,844,579 | 14,901,255 | 14,355,644 |
Total costs and expenses | 9,813,496 | 8,767,436 | 29,684,459 | 36,855,702 |
Loss from operations | (9,813,496) | (8,767,436) | (29,684,459) | (36,780,702) |
Interest income | 610,978 | 243,597 | 1,863,679 | 336,255 |
Net loss and comprehensive loss | $ (9,202,518) | $ (8,523,839) | $ (27,820,780) | $ (36,444,447) |
Basic net loss per common share (in dollars per share) | $ (0.14) | $ (0.16) | $ (0.44) | $ (0.70) |
Diluted net loss per common share (in dollars per share) | $ (0.14) | $ (0.16) | $ (0.44) | $ (0.70) |
Basic weighted-average number of common shares outstanding (in shares) | 64,349,709 | 52,423,944 | 62,992,006 | 52,387,561 |
Diluted weighted-average number of common shares outstanding (in shares) | 64,349,709 | 52,423,944 | 62,992,006 | 52,387,561 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 52,314 | $ 454,448,327 | $ (372,896,990) | $ 81,603,651 |
Balance, shares at Dec. 31, 2021 | 52,313,894 | |||
Common stock issued under stock plans | $ 78 | (78) | ||
Common stock issued under stock plans, shares | 78,550 | |||
Stock-based compensation | 1,080,642 | 1,080,642 | ||
Net loss | (14,653,041) | (14,653,041) | ||
Balance at Mar. 31, 2022 | $ 52,392 | 455,528,891 | (387,550,031) | 68,031,252 |
Balance, shares at Mar. 31, 2022 | 52,392,444 | |||
Balance at Dec. 31, 2021 | $ 52,314 | 454,448,327 | (372,896,990) | 81,603,651 |
Balance, shares at Dec. 31, 2021 | 52,313,894 | |||
Balance at Dec. 31, 2022 | $ 54,378 | 462,461,251 | (419,585,792) | 42,929,837 |
Balance, shares at Dec. 31, 2022 | 54,377,798 | |||
Balance at Mar. 31, 2022 | $ 52,392 | 455,528,891 | (387,550,031) | 68,031,252 |
Balance, shares at Mar. 31, 2022 | 52,392,444 | |||
Common stock issued under stock plans | $ 32 | (32) | ||
Common stock issued under stock plans, shares | 31,500 | |||
Stock-based compensation | 963,758 | 963,758 | ||
Net loss | (13,267,567) | (13,267,567) | ||
Balance at Jun. 30, 2022 | $ 52,424 | 456,492,617 | (400,817,598) | 55,727,443 |
Balance, shares at Jun. 30, 2022 | 52,423,944 | |||
Stock-based compensation | 913,979 | 913,979 | ||
Net loss | (8,523,839) | (8,523,839) | ||
Balance at Sep. 30, 2022 | $ 52,424 | 457,406,596 | (409,341,437) | 48,117,583 |
Balance, shares at Sep. 30, 2022 | 52,423,944 | |||
Balance at Dec. 31, 2022 | $ 54,378 | 462,461,251 | (419,585,792) | 42,929,837 |
Balance, shares at Dec. 31, 2022 | 54,377,798 | |||
Issuance of common stock, net of issuance costs | $ 9,823 | 28,697,188 | 28,707,011 | |
Issuance of common stock, net of issuance costs, shares | 9,822,930 | |||
Common stock issued under stock plans | $ 44 | 33,724 | 33,768 | |
Common stock issued under stock plans, shares | 44,496 | |||
Stock-based compensation | 870,180 | 870,180 | ||
Net loss | (10,359,350) | (10,359,350) | ||
Balance at Mar. 31, 2023 | $ 64,245 | 492,062,343 | (429,945,142) | 62,181,446 |
Balance, shares at Mar. 31, 2023 | 64,245,224 | |||
Common stock issued under stock plans | $ 68 | 20,046 | 20,114 | |
Common stock issued under stock plans, shares | 68,109 | |||
Stock-based compensation | 858,088 | 858,088 | ||
Net loss | (8,258,912) | (8,258,912) | ||
Balance at Jun. 30, 2023 | $ 64,313 | 492,940,477 | (438,204,054) | 54,800,736 |
Balance, shares at Jun. 30, 2023 | 64,313,333 | |||
Common stock issued under stock plans | $ 56 | 61,560 | 61,616 | |
Common stock issued under stock plans, shares | 55,510 | |||
Stock-based compensation | 887,837 | 887,837 | ||
Net loss | (9,202,518) | (9,202,518) | ||
Balance at Sep. 30, 2023 | $ 64,369 | $ 493,889,874 | $ (447,406,572) | $ 46,547,671 |
Balance, shares at Sep. 30, 2023 | 64,368,843 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities | ||
Net loss | $ (27,820,780) | $ (36,444,447) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 130,004 | 161,427 |
Loss on disposal of assets | 3,498 | |
Non-cash lease expense | 668,756 | 611,163 |
Stock-based compensation | 2,616,105 | 2,958,379 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | 241,640 | (1,689,613) |
Prepaid research and development expenses | 752,807 | |
Accounts payable | (640,306) | (1,255,490) |
Accrued expenses | (1,680,629) | (2,903,733) |
Lease liabilities | (779,696) | (739,910) |
Net cash used in operating activities | (27,264,906) | (38,545,919) |
Investing activities | ||
Purchases of property and equipment | (20,593) | (84,190) |
Net cash used in investing activities | (20,593) | (84,190) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 28,707,011 | |
Proceeds from exercise of stock options | 115,498 | |
Net cash provided by financing activities | 28,822,509 | |
Net change in cash and cash equivalents | 1,537,010 | (38,630,109) |
Cash and cash equivalents, beginning of period | 47,870,619 | 90,254,890 |
Cash and cash equivalents, end of period | $ 49,407,629 | $ 51,624,781 |
Description of the Business
Description of the Business | 9 Months Ended |
Sep. 30, 2023 | |
Description of the Business | |
Description of the Business | 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-stage clinical development 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 inflammation, cancer and infection. The Company’s executive personnel have devoted substantially all of their time to date to the planning and organization of the Company, the process of hiring scientists, initiating research and development programs and securing adequate capital for anticipated growth and operations. The Company has not commercialized any of its drug candidates and planned commercial operations have not commenced. The Company has incurred significant losses in the development of its drug candidates. The Company has not generated revenues from product sales. As a result, the Company has consistently reported negative cash flows from operating activities and net losses, had an accumulated deficit of $447.4 million at September 30, 2023 and expects to continue incurring losses for the foreseeable future. The Company believes that its cash and cash equivalents as of September 30, 2023 will be sufficient to fund the Company’s operations for at least 12 months from the issuance of these financial statements. Management intends to fund future operations through additional public or private equity or debt offerings and may seek additional capital through arrangements with strategic partners or from other sources, the securing of which cannot be assured. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies | |
Significant Accounting Policies | 2. Significant Accounting Policies There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the United States Securities and Exchange Commission (the SEC) on March 29, 2023 (the Form 10-K). Basis of Accounting The accompanying unaudited financial statements were prepared based on the accrual method of accounting in accordance with U.S. generally accepted accounting principles (GAAP). Unaudited Financial Statements The accompanying balance sheet as of September 30, 2023, statements of operations and comprehensive loss and stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and statements of cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the 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, 2022 contained in the Form 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, 2023 and its results of operations and changes in its stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and its cash flows for the nine months ended September 30, 2023 and 2022. The December 31, 2022 balance sheet included herein was derived from audited financial statements, but does not include all disclosures including notes required by GAAP for complete annual financial statements. The financial data and other information disclosed in these notes to the financial statements related to the three and nine months ended September 30, 2023 and 2022 are unaudited. Interim results are not necessarily indicative of results for an entire year or for any future period. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Although actual results could differ from those estimates, management does not believe that such differences would be material. Fair Value Measurements The Company had no assets or liabilities that were measured using quoted prices for similar assets and liabilities or significant unobservable inputs (Level 2 and Level 3 assets and liabilities, respectively) as of September 30, 2023 and December 31, 2022. The carrying value of cash held in money market funds of $44.0 million and $45.9 million as of September 30, 2023 and December 31, 2022, respectively, is included in cash and cash equivalents and approximates market values based on quoted market prices (Level 1 inputs). The Company did not transfer any assets measured at fair value on a recurring basis between levels during the three and nine months ended September 30, 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. Revenue Recognition The Company applies Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers 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 9 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: Milestone Payments Royalties Manufacturing and Supply: 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 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 Expected Volatility Risk-Free Interest Rate Expected Term 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 (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: Nine Months Ended September 30, 2023 2022 Stock options and RSUs 10,971,874 9,471,701 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, 2023 and 2022, the Company’s net loss equaled comprehensive net loss and, accordingly, no additional disclosure is presented. Recently Issued Accounting Standards Accounting Standards Not Yet Adopted There have been no new accounting pronouncements that have significance, or potential significance, to the Company’s unaudited financial statements as of and for the nine months ended September 30, 2023. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 3. Prepaid Expenses and Other Current Assets The following is a summary of the Company’s prepaid expenses and other current assets: September 30, December 31, 2023 2022 Prepaid research and development expenses $ 1,810,904 $ 2,300,209 Other prepaid expenses 602,593 399,861 Other receivables 188,949 144,016 Prepaid expenses and other current assets $ 2,602,446 $ 2,844,086 |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment | |
Property and Equipment | 4. Property and Equipment Property and equipment, net consisted of the following: September 30, December 31, 2023 2022 Furniture and fixtures $ 342,203 $ 342,203 Laboratory equipment 1,349,370 1,343,081 Office equipment 18,943 17,762 Computer equipment 316,466 309,826 Leasehold improvements 616,133 616,133 Property and equipment 2,643,115 2,629,005 Less accumulated depreciation (2,510,136) (2,386,615) Property and equipment, net $ 132,979 $ 242,390 Depreciation expense was $42,747 and $47,347 for the three months ended September 30, 2023 and 2022, respectively, and $130,004 and $161,427 for the nine months ended September 30, 2023 and 2022, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Accrued Expenses | 5. Accrued Expenses The following is a summary of the Company’s accrued expenses: September 30, December 31, 2023 2022 Accrued research and development expenses $ 2,345,416 $ 3,484,742 Accrued bonuses 1,717,901 2,664,613 Accrued consulting and other professional fees 550,955 499,592 Accrued employee benefits 680,648 300,653 Other accrued expenses 16,457 42,406 Accrued expenses $ 5,311,377 $ 6,992,006 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Leases | 6. Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company determines a lease exists if the contract conveys the right to control an identified asset for a period of time in exchange for consideration. Control is considered to exist when the lessee has the 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 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 be extended The components of lease expense and related cash flows were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Operating lease cost $ 255,044 $ 231,989 $ 734,393 $ 695,968 Variable lease cost 155,583 153,753 471,879 458,638 Total operating lease cost $ 410,627 $ 385,742 $ 1,206,272 $ 1,154,606 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows for operating leases $ 285,122 $ 278,168 $ 845,332 $ 824,714 Maturities of lease liability due under the Company’s lease agreements as of September 30, 2023 were as follows: Operating Lease Obligation October 1, 2023 - December 31, 2023 $ 226,438 2024 789,183 2025 67,401 Thereafter — Total 1,083,022 Present value adjustment (71,271) Present value of lease payments $ 1,011,751 Supplemental information related to leases were as follows: September 30, December 31, Operating Leases 2023 2022 Weighted-average remaining lease term (in years) 1.29 0.80 Weighted-average incremental borrowing rate 9.9% 8.0% Nine Months Ended September 30, 2023 2022 Right-of-use assets obtained in exchange for operating lease obligations $ 872,892 $ - |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | 7. Stockholders’ Equity At-The-Market Sales Facility 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 an at-the-market sales agreement previously entered into with Cowen and Company, LLC (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 During the quarter ended March 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. There have been no sales subsequent to March 31, 2023. As of September 30, 2023, approximately $66.0 million remained available to be sold under the terms of the 2022 Sales Agreement. 2013 Equity Incentive Plan The Company’s board of directors adopted, and its stockholders approved, its 2013 Equity Incentive Plan (the 2013 Plan) effective on January 9, 2014. In April 2022, the Company’s board of directors approved an amendment and restatement of the 2013 Plan, which was approved by the Company’s stockholders at the Company’s annual meeting of stockholders held in May 2022 (as so amended, the Amended 2013 Plan). The Amended 2013 Plan provides for the grant of incentive stock options within the meaning of Section 422 of the Internal Revenue Code to the Company’s employees and its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock awards, RSU awards, stock appreciation rights, performance stock awards and other forms of stock compensation to its employees, including officers, consultants and directors. The Amended 2013 Plan also provides for the grant of performance cash awards to the Company’s employees, consultants and directors. Unless otherwise stated in a stock option agreement, 25% of the shares subject to an option grant will typically vest upon the first anniversary of the vesting start date, with the balance of the shares vesting in a series of thirty-six successive equal monthly installments as of the first day of each month measured from the first anniversary of the vesting start date. Upon termination of employment by reasons other than death, cause, or disability, any vested options will terminate 90 days after the termination date, unless otherwise set forth in a stock option agreement. Stock options generally terminate 10 years from the date of grant. Authorized Shares The maximum number of shares of common stock that initially could be issued under the 2013 Plan was Following the approval of the Amended 2013 Plan by the Company’s stockholders, the share reserve under the Amended 2013 Plan was increased by 2,619,622 shares, and beginning on January 1, 2023 and ending on (and including) January 1, 2029, the maximum number of shares of common stock that may be issued under the Amended 2013 Plan will cumulatively be increased by 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or such lesser number of shares as determined by the board of directors or the compensation committee thereof. reserved for issuance under the Amended 2013 Plan was 11,681,878 shares, of which 2,592,669 shares were available for future grants. Shares issued under the Amended 2013 Plan may be authorized but unissued or reacquired shares of common stock. Shares subject to stock awards granted under the Amended 2013 Plan that expire or terminate without being exercised in full, or that are paid out in cash rather than in shares, will not reduce the number of shares available for issuance under the Amended 2013 Plan. Additionally, shares issued pursuant to stock awards under the Amended 2013 Plan that the Company repurchases or that are forfeited, as well as shares reacquired by the Company as consideration for the exercise or purchase price of a stock award or to satisfy tax withholding obligations related to a stock award, will become available for future grant under the Amended 2013 Plan. A summary of the Company’s stock option activity under the Amended 2013 Plan for the nine months ended September 30, 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 2,451,050 2.55 Options exercised (100,060) 1.15 Options forfeited (896,882) 6.16 Outstanding as of September 30, 2023 8,228,900 5.32 6.4 $ 655 Vested or expected to vest as of September 30, 2023 8,087,000 5.39 6.4 599 Exercisable as of September 30, 2023 4,849,652 7.43 4.6 307 As of September 30, 2023, there was $4,825,031 of total unrecognized compensation expense related to unvested options under the Amended 2013 Plan that will be recognized over a weighted-average period of approximately 2.7 years. Total intrinsic value of the options exercised during the nine months ended September 30, 2023 was $82,093 and total cash received for options exercised was $115,498. There were no options exercised under the Amended 2013 Plan during the nine months ended September 30, 2022. The total fair value of stock options which vested in the nine months ended September 30, 2023 and 2022 was $1,402,470 and $2,699,940, respectively. In January 2022, the Company granted stock options to purchase an aggregate of 141,900 shares to certain employees under the 2013 Plan which were subject to performance vesting conditions. The shares will vest upon achievement of milestones as follows: (i) one one 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 RSUs granted vest over four years in equal installments on each anniversary of the grant date, provided that the employee remains employed by the Company at the applicable vesting date. Compensation expense is recognized on a straight-line basis. As of September 30, 2023, there was $291,489 of total unrecognized compensation expense associated with outstanding RSU grants that will be recognized over a weighted-average period of approximately 1.3 years. The following is a summary of RSU activity under the Amended 2013 Plan for the nine months ended September 30, 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 September 30, 2023 117,157 3.81 Other Awards 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 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. On September 29, 2023, the Company issued 24,001 shares of Common Stock to non-employee directors who elected to receive shares in lieu of cash for their third quarter 2023 compensation, which was the first quarter for which an election could be made. All shares of common stock issued pursuant to such an election are fully vested upon issuance and are issued as “Other Awards” under the Amended 2013 Plan. Inducement Plan The Company’s board of directors previously adopted the GlycoMimetics, Inc. Inducement Plan (as amended to date, the Inducement Plan). The Inducement Plan provides for the grant of nonstatutory stock options, restricted stock awards, RSU awards, stock appreciation rights and other forms of stock awards to individuals not previously an employee or director of the Company as an inducement for such individuals to join the Company. Unless otherwise stated in an applicable stock option agreement, one A summary of the Company’s stock option activity under the Inducement Plan for the nine months ended September 30, 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 (67,708) 1.38 Outstanding as of September 30, 2023 2,625,817 1.96 8.1 $ 262 Vested or expected to vest as of September 30, 2023 2,041,617 1.95 8.2 247 Exercisable as of September 30, 2023 820,225 1.89 7.6 80 As of September 30, 2023, there was $1,666,940 of total unrecognized compensation expense related to unvested options under the Inducement Plan that will be recognized over a weighted-average period of approximately 2.6 years. There were no options exercised under the Inducement Plan during the nine months ended September 30, 2023 or 2022. The total fair value of stock options which vested in the nine months ended September 30, 2023 and 2022 was $469,179 and $460,950, respectively. During 2021 and the nine months ended September 30, 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 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 September 30, 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 nine months ended September 30, 2023 and 2022 was $1.97 per share and $0.76 per share, respectively, applying the Black-Scholes-Merton option pricing model utilizing the following weighted-average assumptions: Nine Months Ended September 30, 2023 2022 Expected term 6.25 years 6.25 years Expected volatility 78.12% 84.66% Risk-free interest rate 3.57% 1.90% Expected dividend yield 0% 0% Stock-based compensation expense was classified on the statements of operations as follows for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development expense $ 211,047 $ 242,627 $ 678,400 $ 831,502 General and administrative expense 676,790 671,352 1,937,705 2,126,877 Total stock-based compensation expense $ 887,837 $ 913,979 $ 2,616,105 $ 2,958,379 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes | |
Income Taxes | 8. Income Taxes The Company did not record any tax provision or benefit for the nine months ended September 30, 2023 or 2022. The Company has provided a valuation allowance for the full amount of its net deferred tax assets since realization of any future benefit from deductible temporary differences, net operating loss carryforwards and research and development credits is not more-likely-than-not to be realized at September 30, 2023 and December 31, 2022. |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2023 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | 9. License and Collaboration Agreements Apollomics In 2020, the Company entered into a collaboration and license agreement (the Agreement) with Apollomics (Hong Kong), Limited (Apollomics) for the development, manufacture and commercialization of products derived from two of the Company’s compounds, GMI-1271 and GMI-1687 (the Products) for therapeutic and prophylactic uses (the Field) in China, Taiwan, Hong Kong and Macau (the Territory). Under the terms of the Agreement, the Company granted Apollomics: ● an exclusive license, with the right to sublicense, to develop, manufacture and have manufactured, distribute, market, promote, sell, have sold, offer for sale, import, label, package and otherwise the Products in the Field in the Territory; and ● a non-exclusive license to conduct preclinical research with respect to Products in the Field outside of the Territory for the purposes of developing such Products for use in the Territory. In 2020, the Company and Apollomics also 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. The Company did not recognize any revenue under the clinical supplies agreement during the nine months ended September 30, 2023 and 2022. The Company evaluated the Agreement under the provisions of ASC 606 and identified two performance obligations under this revenue arrangement: the (i) delivery of functional licenses and (ii) manufacture and supply of the Products. The initial transaction price consists of a $9.0 million non-refundable up-front payment which was allocated to the delivered functional licenses and recognized in full as revenue in 2020 given that the performance obligation was satisfied upon inception. The Agreement contains various forms of variable consideration, including (i) up to $75.0 million in development milestones based on achievement of certain clinical 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. In 2020, the Company received a non-refundable $1.0 million development milestone payment upon acceptance by Chinese regulatory authorities of a Phase 3 bridging study design to support registration in China and recognized this $1.0 million payment as revenue at that time. The Company did not recognize any milestone revenue under the Agreement for the nine months ended September 30, 2023 or 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 (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. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies | |
Basis of Accounting | Basis of Accounting The accompanying unaudited financial statements were prepared based on the accrual method of accounting in accordance with U.S. generally accepted accounting principles (GAAP). |
Unaudited Financial Statements | Unaudited Financial Statements The accompanying balance sheet as of September 30, 2023, statements of operations and comprehensive loss and stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and statements of cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the 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, 2022 contained in the Form 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, 2023 and its results of operations and changes in its stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and its cash flows for the nine months ended September 30, 2023 and 2022. The December 31, 2022 balance sheet included herein was derived from audited financial statements, but does not include all disclosures including notes required by GAAP for complete annual financial statements. The financial data and other information disclosed in these notes to the financial statements related to the three and nine months ended September 30, 2023 and 2022 are unaudited. Interim results are not necessarily indicative of results for an entire year or for any future period. |
Use of Estimates | 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 | Fair Value Measurements The Company had no assets or liabilities that were measured using quoted prices for similar assets and liabilities or significant unobservable inputs (Level 2 and Level 3 assets and liabilities, respectively) as of September 30, 2023 and December 31, 2022. The carrying value of cash held in money market funds of $44.0 million and $45.9 million as of September 30, 2023 and December 31, 2022, respectively, is included in cash and cash equivalents and approximates market values based on quoted market prices (Level 1 inputs). The Company did not transfer any assets measured at fair value on a recurring basis between levels during the three and nine months ended September 30, 2023 and 2022. |
Concentration of Credit Risk | 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. |
Revenue Recognition | Revenue Recognition The Company applies Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers 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 9 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: Milestone Payments Royalties Manufacturing and Supply: |
Accruals for Clinical Trial Expenses | 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 Compensation Stock-based payments are accounted for in accordance with the provisions of ASC 718, Compensation—Stock Compensation 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 Expected Volatility Risk-Free Interest Rate Expected Term |
Net Loss Per Common Share | 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 (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: Nine Months Ended September 30, 2023 2022 Stock options and RSUs 10,971,874 9,471,701 |
Comprehensive Loss | 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, 2023 and 2022, the Company’s net loss equaled comprehensive net loss and, accordingly, no additional disclosure is presented. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards Accounting Standards Not Yet Adopted There have been no new accounting pronouncements that have significance, or potential significance, to the Company’s unaudited financial statements as of and for the nine months ended September 30, 2023. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies | |
Potentially dilutive securities outstanding | Nine Months Ended September 30, 2023 2022 Stock options and RSUs 10,971,874 9,471,701 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses and Other Current Assets | |
Summary of 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, 2023 2022 Prepaid research and development expenses $ 1,810,904 $ 2,300,209 Other prepaid expenses 602,593 399,861 Other receivables 188,949 144,016 Prepaid expenses and other current assets $ 2,602,446 $ 2,844,086 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment | |
Summary of Property and Equipment useful lives | Property and equipment, net consisted of the following: September 30, December 31, 2023 2022 Furniture and fixtures $ 342,203 $ 342,203 Laboratory equipment 1,349,370 1,343,081 Office equipment 18,943 17,762 Computer equipment 316,466 309,826 Leasehold improvements 616,133 616,133 Property and equipment 2,643,115 2,629,005 Less accumulated depreciation (2,510,136) (2,386,615) Property and equipment, net $ 132,979 $ 242,390 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Summary of Accrued Expenses | September 30, December 31, 2023 2022 Accrued research and development expenses $ 2,345,416 $ 3,484,742 Accrued bonuses 1,717,901 2,664,613 Accrued consulting and other professional fees 550,955 499,592 Accrued employee benefits 680,648 300,653 Other accrued expenses 16,457 42,406 Accrued expenses $ 5,311,377 $ 6,992,006 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Components of lease expense and related cash flows | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Operating lease cost $ 255,044 $ 231,989 $ 734,393 $ 695,968 Variable lease cost 155,583 153,753 471,879 458,638 Total operating lease cost $ 410,627 $ 385,742 $ 1,206,272 $ 1,154,606 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows for operating leases $ 285,122 $ 278,168 $ 845,332 $ 824,714 |
Maturities of lease liabilities due | Operating Lease Obligation October 1, 2023 - December 31, 2023 $ 226,438 2024 789,183 2025 67,401 Thereafter — Total 1,083,022 Present value adjustment (71,271) Present value of lease payments $ 1,011,751 |
Schedule of supplemental information related to leases | September 30, December 31, Operating Leases 2023 2022 Weighted-average remaining lease term (in years) 1.29 0.80 Weighted-average incremental borrowing rate 9.9% 8.0% Nine Months Ended September 30, 2023 2022 Right-of-use assets obtained in exchange for operating lease obligations $ 872,892 $ - |
Stockholders Equity (Tables)
Stockholders Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Weighted-Average Fair Value of Options Granted | Nine Months Ended September 30, 2023 2022 Expected term 6.25 years 6.25 years Expected volatility 78.12% 84.66% Risk-free interest rate 3.57% 1.90% Expected dividend yield 0% 0% |
Stock-Based Compensation Expense | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development expense $ 211,047 $ 242,627 $ 678,400 $ 831,502 General and administrative expense 676,790 671,352 1,937,705 2,126,877 Total stock-based compensation expense $ 887,837 $ 913,979 $ 2,616,105 $ 2,958,379 |
2013 Equity Incentive Plan | |
Company's Stock Option Activity | 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 2,451,050 2.55 Options exercised (100,060) 1.15 Options forfeited (896,882) 6.16 Outstanding as of September 30, 2023 8,228,900 5.32 6.4 $ 655 Vested or expected to vest as of September 30, 2023 8,087,000 5.39 6.4 599 Exercisable as of September 30, 2023 4,849,652 7.43 4.6 307 |
Summary of RSU Activity | 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 September 30, 2023 117,157 3.81 |
Inducement Plan | |
Company's Stock Option Activity | 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 (67,708) 1.38 Outstanding as of September 30, 2023 2,625,817 1.96 8.1 $ 262 Vested or expected to vest as of September 30, 2023 2,041,617 1.95 8.2 247 Exercisable as of September 30, 2023 820,225 1.89 7.6 80 |
Description of the Business (De
Description of the Business (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Description of the Business | ||
Accumulated deficit | $ (447,406,572) | $ (419,585,792) |
Significant Accounting Polici_4
Significant Accounting Policies - Fair Value Measurements (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Level 1 | ||
Fair Value Measurements | ||
Carrying value of cash held in money market fund | $ 44 | $ 45.9 |
Level 2 | ||
Fair Value Measurements | ||
Assets measured at fair value levels 2 or 3 | 0 | 0 |
Liabilities measured at fair value levels 2 or 3 | 0 | 0 |
Level 3 | ||
Fair Value Measurements | ||
Assets measured at fair value levels 2 or 3 | 0 | 0 |
Liabilities measured at fair value levels 2 or 3 | $ 0 | $ 0 |
Significant Accounting Polici_5
Significant Accounting Policies - Potentially Dilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Stock options and restricted stock units | ||
Anti-dilutive securities | 10,971,874 | 9,471,701 |
Significant Accounting Polici_6
Significant Accounting Policies - Stock-Based Compensation (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Defined Contribution Plan Disclosure | ||
Expected term | 6 years 3 months | 6 years 3 months |
Maximum | ||
Defined Contribution Plan Disclosure | ||
Expiration period | 10 years |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets | ||
Prepaid research and development expenses | $ 1,810,904 | $ 2,300,209 |
Other prepaid expenses | 602,593 | 399,861 |
Other receivables | 188,949 | 144,016 |
Prepaid expenses and other current assets | $ 2,602,446 | $ 2,844,086 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Property, Plant and Equipment | |||||
Property and equipment | $ 2,643,115 | $ 2,643,115 | $ 2,629,005 | ||
Less accumulated depreciation | (2,510,136) | (2,510,136) | (2,386,615) | ||
Property and equipment, net | 132,979 | 132,979 | 242,390 | ||
Depreciation of property and equipment | 42,747 | $ 47,347 | 130,004 | $ 161,427 | |
Furniture and Fixtures | |||||
Property, Plant and Equipment | |||||
Property and equipment | 342,203 | 342,203 | 342,203 | ||
Laboratory Equipment | |||||
Property, Plant and Equipment | |||||
Property and equipment | 1,349,370 | 1,349,370 | 1,343,081 | ||
Office Equipment | |||||
Property, Plant and Equipment | |||||
Property and equipment | 18,943 | 18,943 | 17,762 | ||
Computer Equipment | |||||
Property, Plant and Equipment | |||||
Property and equipment | 316,466 | 316,466 | 309,826 | ||
Leasehold Improvements | |||||
Property, Plant and Equipment | |||||
Property and equipment | $ 616,133 | $ 616,133 | $ 616,133 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Accrued research and development expenses | $ 2,345,416 | $ 3,484,742 |
Accrued bonuses | 1,717,901 | 2,664,613 |
Accrued consulting and other professional fees | 550,955 | 499,592 |
Accrued employee benefits | 680,648 | 300,653 |
Other accrued expenses | 16,457 | 42,406 |
Accrued expenses | $ 5,311,377 | $ 6,992,006 |
Leases (Details)
Leases (Details) | 9 Months Ended | |||
Sep. 30, 2023 USD ($) | Apr. 30, 2023 ft² | Dec. 31, 2022 USD ($) | May 31, 2016 USD ($) | |
Operating leases | ||||
Security Deposit | $ | $ 52,320 | $ 52,320 | ||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | |||
Rockville, Maryland | ||||
Operating leases | ||||
Security Deposit | $ | $ 52,320 | |||
First portion of Rockville, Maryland lease | ||||
Operating leases | ||||
Square feet leased | ft² | 30,000 | |||
Second portion of Rockville, Maryland lease | ||||
Operating leases | ||||
Square feet leased | ft² | 12,000 |
Leases - Components of lease ex
Leases - Components of lease expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Components of lease expense | ||||
Operating lease cost | $ 255,044 | $ 231,989 | $ 734,393 | $ 695,968 |
Variable lease cost | 155,583 | 153,753 | 471,879 | 458,638 |
Total operating lease cost | 410,627 | 385,742 | 1,206,272 | 1,154,606 |
Cash paid for amounts included in the measurement of lease liabilities: | ||||
Operating cash outflows from operating leases | $ 285,122 | $ 278,168 | $ 845,332 | $ 824,714 |
Leases - Maturities of lease li
Leases - Maturities of lease liability (Details) | Sep. 30, 2023 USD ($) |
Maturities of lease liability due | |
October 1, 2023 - December 31, 2023 | $ 226,438 |
2024 | 789,183 |
2025 | 67,401 |
Thereafter | |
Total | 1,083,022 |
Present value adjustment | (71,271) |
Present value of lease payments | $ 1,011,751 |
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Operating Lease, Liability, Current, Operating Lease, Liability, Noncurrent |
Leases - Supplemental Informati
Leases - Supplemental Information (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Leases | ||
Weighted-average remaining lease term (in years) | 1 year 3 months 14 days | 9 months 18 days |
Weighted-average incremental borrowing rate | 9.90% | 8% |
Right-of-use assets obtained in exchange for operating lease obligations | $ 872,892 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Apr. 28, 2022 | |
Common Stock | ||||
Equity offerings | ||||
Issuance of common stock, net of issuance costs, shares | 9,822,930 | |||
2022 Sales Agreement | ||||
Equity offerings | ||||
Issuance of common stock, net of issuance costs, shares | 9,822,930 | 1,953,854 | ||
Price per share | $ 3.01 | $ 2.22 | ||
Aggregate net proceeds from stock sale | $ 28.7 | $ 0 | $ 4.2 | |
Common stock available for sale under agreement | $ 66 | $ 100 |
Stockholders' Equity - Incentiv
Stockholders' Equity - Incentive Plans (Details) | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jan. 09, 2014 installment shares | Jan. 31, 2022 USD ($) shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) shares | Dec. 31, 2021 shares | |
Maximum | |||||
Incentive plans | |||||
Expiration period | 10 years | ||||
2013 Equity Incentive Plan | |||||
Incentive plans | |||||
Period from date of termination that any vested options shall expire | 90 days | ||||
Expiration period | 10 years | ||||
Unrecognized compensation expense related to unvested options | $ | $ 4,825,031 | ||||
Period for unrecognized compensation expense related to unvested options yet has not been recognized | 2 years 8 months 12 days | ||||
Intrinsic value of options exercised | $ | $ 82,093 | ||||
Cash proceeds from exercise of stock options | $ | $ 115,498 | ||||
Shares issued from exercise of stock options | 100,060 | 0 | |||
Fair value of shares vested | $ | $ 1,402,470 | $ 2,699,940 | |||
Authorized shares | |||||
Common stock authorized | 1,000,000 | ||||
Automatic increase in number of shares reserved for issuance as a percentage of the total common stock outstanding at the end of the prior year | 3% | ||||
Increase in number of shares of common stock | 2,619,622 | ||||
Maximum percentage of shares of common stock issued and outstanding on the immediately preceding fiscal year, or such lesser number of shares as determined by the board of directors or the compensation committee | 4% | ||||
Options granted | 2,451,050 | ||||
2013 Equity Incentive Plan | Stock options vesting based on performance | |||||
Incentive plans | |||||
Percent of shares subject to option grant that will vest | 50% | ||||
Maximum fair value of option excluded from the unrecognized compensation expense | $ | $ 825,353 | ||||
2013 Equity Incentive Plan | Stock options vesting based on performance | Non-executive employees | |||||
Incentive plans | |||||
Maximum fair value of option excluded from the unrecognized compensation expense | $ | $ 113,520 | ||||
Authorized shares | |||||
Options granted | 141,900 | ||||
2013 Equity Incentive Plan | Stock options vesting based on performance | Newly hired employees | |||||
Authorized shares | |||||
Options granted | 584,200 | 584,200 | |||
2013 Equity Incentive Plan | Upon first anniversary of start date | |||||
Incentive plans | |||||
Percent of shares subject to option grant that will vest | 25% | ||||
2013 Equity Incentive Plan | Each month after the first anniversary | |||||
Incentive plans | |||||
Number of monthly installments | installment | 36 | ||||
2013 Equity Incentive Plan | Vesting upon FDA Approval | Stock options vesting based on performance | |||||
Incentive plans | |||||
Percent of shares subject to option grant that will vest | 50% | ||||
Common Stock | 2013 Equity Incentive Plan | |||||
Authorized shares | |||||
Common stock authorized | 11,681,878 | ||||
Shares available for future grants | 2,592,669 | ||||
Maximum number of shares that may be issued pursuant to exercise of incentive stock | 20,000,000 |
Stockholders' Equity - Company'
Stockholders' Equity - Company's Stock Option Activity (Details) - 2013 Equity Incentive Plan - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
OUTSTANDING OPTIONS | |||
Outstanding at beginning of period | 6,774,792 | ||
Options granted | 2,451,050 | ||
Options exercised | (100,060) | 0 | |
Options forfeited | (896,882) | ||
Outstanding at end of period | 8,228,900 | 6,774,792 | |
WEIGHTED-AVERAGE EXERCISE PRICE | |||
Outstanding at beginning of period | $ 6.37 | ||
Options granted | 2.55 | ||
Options exercised | 1.15 | ||
Options forfeited | 6.16 | ||
Outstanding at end of period | $ 5.32 | $ 6.37 | |
VESTED AND EXPECTED TO VEST | |||
Outstanding options | 8,087,000 | ||
Weighted-Average Exercise Price | $ 5.39 | ||
Weighted-Average Remaining Contractual Term | 6 years 4 months 24 days | ||
Aggregate Intrinsic Value (in thousands) | $ 599 | ||
ADDITIONAL DISCLOSURES | |||
Outstanding options exercisable at end of period | 4,849,652 | ||
Weighted-average exercise price exercisable at end of period | $ 7.43 | ||
Weighted-average contractual term outstanding | 6 years 4 months 24 days | 6 years 1 month 6 days | |
Weighted-average contractual term (years) exercisable | 4 years 7 months 6 days | ||
Aggregate intrinsic value (in thousands) outstanding at end of period | $ 655 | ||
Aggregate intrinsic value (in thousands) exercisable at end of period | $ 307 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of RSU Activity (Details) - 2013 Equity Incentive Plan | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Restricted Stock Units information | |
Period for unrecognized compensation expense related to unvested options yet has not been recognized | 2 years 8 months 12 days |
RSU | |
NUMBER OF SHARES | |
Unvested at beginning of period | shares | 204,785 |
Forfeited | shares | (19,573) |
Vested | shares | (68,055) |
Unvested at end of period | shares | 117,157 |
WEIGHTED-AVERAGE GRANT DATE FAIR VALUE | |
Unvested at beginning of period | $ / shares | $ 3.81 |
Forfeited | $ / shares | 3.81 |
Vested | $ / shares | 3.81 |
Unvested at end of period | $ / shares | $ 3.81 |
RSU | Non-executive employees | |
Restricted Stock Units information | |
Vesting period | 4 years |
Unrecognized compensation expense related to unvested service RSUs | $ | $ 291,489 |
Period for unrecognized compensation expense related to unvested options yet has not been recognized | 1 year 3 months 18 days |
Stockholders' Equity - Other Aw
Stockholders' Equity - Other Awards (Details) | Sep. 29, 2023 shares |
Common Stock | Non-employee directors | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Common stock shares issued | 24,001 |
Stockholders' Equity - Induceme
Stockholders' Equity - Inducement Plan (Details) - Inducement Plan | 1 Months Ended | 9 Months Ended | |
Jan. 31, 2020 installment | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) shares | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Period from date of termination that any vested options shall expire | 90 days | ||
Expiration period | 10 years | ||
Unrecognized compensation expense related to unvested options | $ | $ 1,666,940 | ||
Period for unrecognized compensation expense related to unvested options yet has not been recognized | 2 years 7 months 6 days | ||
Shares available for future grants | 364,091 | ||
Fair value of shares vested | $ | $ 469,179 | $ 460,950 | |
Options exercised | 0 | 0 | |
Upon first anniversary of start date | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Vesting percentage | 25% | ||
Each month after the first anniversary | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Number of monthly installments | installment | 36 | ||
Common Stock | Each month after the first anniversary | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Increase in number of shares of common stock | 3,000,000 |
Stockholders' Equity - Induce_2
Stockholders' Equity - Inducement Plan - Stock Option Activity (Details) - Inducement Plan - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
OUTSTANDING OPTIONS | |||
Outstanding at beginning of period | 2,333,525 | ||
Options granted | 360,000 | ||
Options exercised | 0 | 0 | |
Options forfeited | (67,708) | ||
Outstanding at end of period | 2,625,817 | 2,333,525 | |
WEIGHTED-AVERAGE EXERCISE PRICE | |||
Outstanding at beginning of period | $ 1.82 | ||
Options granted | 2.76 | ||
Options forfeited | 1.38 | ||
Outstanding at end of period | $ 1.96 | $ 1.82 | |
VESTED AND EXPECTED TO VEST | |||
Outstanding options | 2,041,617 | ||
Weighted-Average Exercise Price | $ 1.95 | ||
Weighted-Average Remaining Contractual Term | 8 years 2 months 12 days | ||
Aggregate Intrinsic Value (in thousands) | $ 247 | ||
ADDITIONAL DISCLOSURES | |||
Outstanding options exercisable at end of period | 820,225 | ||
Weighted-average exercise price exercisable at end of period | $ 1.89 | ||
Weighted-average contractual term outstanding | 8 years 1 month 6 days | 8 years 8 months 12 days | |
Weighted-average contractual term (years) exercisable | 7 years 7 months 6 days | ||
Aggregate intrinsic value (in thousands) outstanding at end of period | $ 262 | ||
Aggregate intrinsic value (in thousands) exercisable at end of period | $ 80 |
Stockholders' Equity - Weighted
Stockholders' Equity - Weighted-Average assumptions (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Weighted-average assumptions | ||
Expected term | 6 years 3 months | 6 years 3 months |
Expected volatility | 78.12% | 84.66% |
Risk-free interest rate | 3.57% | 1.90% |
Expected dividend yield | 0% | 0% |
2013 Equity Incentive and Inducement Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Weighted-average fair value of the options granted | $ 1.97 | $ 0.76 |
Stockholders' Equity - Stock-Ba
Stockholders' Equity - Stock-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 887,837 | $ 913,979 | $ 2,616,105 | $ 2,958,379 |
Research and Development | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | 211,047 | 242,627 | 678,400 | 831,502 |
General and Administrative Expense | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 676,790 | $ 671,352 | $ 1,937,705 | $ 2,126,877 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2022 | |
Research and License Agreements | |||
Revenue from collaboration and license agreements | $ 75,000 | ||
Apollomics, Inc. | |||
Research and License Agreements | |||
Up-front payment received | $ 9,000,000 | ||
Milestones based on achievement of certain clinical and regulatory events | 75,000,000 | ||
Milestone payment upon achievement of specified net sales thresholds for all licensed products | $ 105,000,000 | ||
Milestone revenue recognized based on achievement of certain clinical and regulatory events | $ 1,000,000 | ||
Apollomics, Inc. | Maximum | |||
Research and License Agreements | |||
Tiered percentage of annual net sales | 15% |