Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Apr. 12, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-40045 | ||
Entity Registrant Name | NEXIMMUNE, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-2518457 | ||
Entity Address, Address Line One | 9119 Gaither Road | ||
Entity Address, City or Town | Gaithersburg | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 20877 | ||
City Area Code | 301 | ||
Local Phone Number | 825-9810 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | NEXI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 5.8 | ||
Entity Common Stock, Shares Outstanding | 1,371,051 | ||
Documents Incorporated by Reference | None. | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001538210 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Tysons, Virginia |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 3,202,452 | $ 34,642,340 |
Restricted cash | 20,000 | 55,000 |
Assets held for sale | 1,444,043 | 0 |
Prepaid expenses and other current assets | 734,464 | 2,671,411 |
Total current assets | 5,400,959 | 37,368,751 |
Property and equipment, net | 1,352,901 | 4,459,071 |
Operating lease right-of-use assets, net | 46,716 | 967,032 |
Other non-current assets | 1,793,373 | 264,970 |
Total assets | 8,593,949 | 43,059,824 |
Current liabilities: | ||
Accounts payable | 1,336,318 | 2,377,374 |
Accrued expenses and other current liabilities | 3,679,105 | 7,357,153 |
Operating lease liabilities, current | 68,809 | 599,047 |
Total current liabilities | 5,084,232 | 10,333,574 |
Operating lease liabilities, non-current | 0 | 425,766 |
Total liabilities | 5,084,232 | 10,759,340 |
Commitments and contingencies | ||
Stockholders’ equity | ||
Common Stock, $0.0001 par value, 250,000,000 shares authorized as of December 31, 2023 and 2022, 1,066,320 and 1,043,138 issued and outstanding as of December 31, 2023 and 2022 | 2,646 | 2,608 |
Additional paid-in-capital | 226,101,118 | 222,547,530 |
Accumulated deficit | (222,594,047) | (190,249,654) |
Total stockholders’ equity | 3,509,717 | 32,300,484 |
Total liabilities and stockholders’ equity | $ 8,593,949 | $ 43,059,824 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) | Oct. 18, 2023 | Dec. 31, 2023 $ / shares shares | Dec. 31, 2022 $ / shares shares |
Statement of Financial Position [Abstract] | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |
Authorized common stock (in shares) | 250,000,000 | 250,000,000 | |
Common stock, shares issued (in shares) | 1,066,320 | 1,043,138 | |
Common stock, shares outstanding (in shares) | 1,066,320 | 1,043,138 | |
Stock split, conversion ratio | 0.04 |
Statements Of Operations
Statements Of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 19,282,230 | $ 47,148,450 |
General and administrative | 13,000,624 | 15,934,439 |
Loss on assets held for sale | 690,768 | 0 |
Total operating expenses | 32,973,622 | 63,082,889 |
Loss from operations | (32,973,622) | (63,082,889) |
Other income (expense), net: | ||
Interest income | 698,395 | 664,372 |
Other expense | (69,166) | (87,682) |
Total other income, net | 629,229 | 576,690 |
Net loss | (32,344,393) | (62,506,199) |
Net loss available to common stockholders’ | $ (32,344,393) | $ (62,506,199) |
Basic net loss attributable to common stockholders per common share (in dollars per share) | $ (30.82) | $ (64.95) |
Diluted net loss attributable to common stockholders per common share (in dollars per share) | $ (30.82) | $ (64.95) |
Basic weighted average number of common shares outstanding (in shares) | 1,049,468 | 962,364 |
Diluted weighted-average number of common shares outstanding (in shares) | 1,049,468 | 962,364 |
Statement of Operations (Parent
Statement of Operations (Parenthetical) | Oct. 18, 2023 |
Income Statement [Abstract] | |
Stock split, conversion ratio | 0.04 |
Statements Of Comprehensive Los
Statements Of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (32,344,393) | $ (62,506,199) |
Other comprehensive income (loss): | ||
Unrealized gain loss on available-for-sale marketable securities, net of tax | 0 | (3,012) |
Comprehensive loss | $ (32,344,393) | $ (62,509,211) |
Statement of Comprehensive Loss
Statement of Comprehensive Loss (Parenthetical) | Oct. 18, 2023 |
Statement of Comprehensive Income [Abstract] | |
Stock split, conversion ratio | 0.04 |
Statements Of Changes In Stockh
Statements Of Changes In Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income/ (Loss) |
Balance (in shares) at Dec. 31, 2021 | 913,156 | ||||
Balance at Dec. 31, 2021 | $ 83,760,667 | $ 2,283 | $ 211,498,827 | $ (127,743,455) | $ 3,012 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 5,870,364 | 5,870,364 | |||
Issuance of common stock, net of transaction costs (in shares) | 127,396 | ||||
Issuance of common stock, net of transaction costs | 5,145,409 | $ 319 | 5,145,090 | ||
Exercise of stock options (in shares) | 516 | ||||
Exercise of stock options | 33,255 | $ 1 | 33,254 | ||
Cashless exercise of options for common stock (in shares) | 2,070 | ||||
Cashless exercise of options for common stock | 0 | $ 5 | (5) | ||
Unrealized loss on marketable available-for-sale securities | (3,012) | (3,012) | |||
Net loss | (62,506,199) | (32,344,393) | |||
Balance (in shares) at Dec. 31, 2022 | 1,043,138 | ||||
Balance at Dec. 31, 2022 | 32,300,484 | $ 2,608 | 222,547,530 | (190,249,654) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Settlement of restricted stock units, net (in shares) | 23,258 | ||||
Settlement of restricted stock units, net | 0 | $ 38 | (38) | ||
Fractional shares adjustment due to reverse split (in shares) | (76) | ||||
Stock-based compensation | $ 3,553,626 | 3,553,626 | |||
Exercise of stock options (in shares) | 0 | ||||
Unrealized loss on marketable available-for-sale securities | $ 0 | ||||
Net loss | (32,344,393) | ||||
Balance (in shares) at Dec. 31, 2023 | 1,066,320 | ||||
Balance at Dec. 31, 2023 | $ 3,509,717 | $ 2,646 | $ 226,101,118 | $ (222,594,047) | $ 0 |
Statements Of Changes In Stoc_2
Statements Of Changes In Stockholders' Equity (Parenthetical) | Oct. 18, 2023 |
Statement of Financial Position [Abstract] | |
Stock split, conversion ratio | 0.04 |
Statements Of Cash Flows
Statements Of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (32,344,393) | $ (62,506,199) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,024,973 | 994,792 |
Accretion income on available-for-sale marketable securities, net | 0 | (1,131) |
Loss on assets held for sale | 690,768 | 0 |
Gain or loss on assets disposal | (14,492) | 21,264 |
Stock-based compensation | 3,553,626 | 5,870,364 |
Non-cash lease expense | 537,406 | 500,553 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 1,946,949 | 1,723,506 |
Other non-current assets | (1,528,403) | 59,129 |
Accounts payable | (1,041,058) | 1,387,057 |
Accrued expenses and other | (3,682,677) | 1,258,098 |
Operating lease liabilities | (573,095) | (498,353) |
Net cash used in operating activities | (31,430,396) | (51,190,920) |
Cash flows from investing activities | ||
Purchase of property and equipment | (48,720) | (1,255,116) |
Proceeds from disposal of equipment | 4,228 | 80,800 |
Purchases of available-for-sale marketable securities | 0 | (21,509,940) |
Proceeds from maturities of available-for-sale marketable securities | 0 | 71,500,000 |
Proceeds from redemption of available-for-sale marketable securities | 0 | 1,500,000 |
Net cash (used in) provided by investing activities | (44,492) | 50,315,744 |
Cash flows from financing activities | ||
Proceeds from "at-the-market" offering facility, net of transaction costs | 0 | 5,145,409 |
Proceeds from the exercise of stock options | 0 | 33,255 |
Net cash provided by financing activities | 0 | 5,178,664 |
Net increase in cash, cash equivalents and restricted cash | (31,474,888) | 4,303,488 |
Net cash, cash equivalents and restricted cash at beginning of period | 34,697,340 | 30,393,852 |
Net cash, cash equivalents and restricted cash at end of period | 3,222,452 | 34,697,340 |
Supplemental disclosure of noncash investing and financing activities: | ||
Leased assets exchanged for operating lease liabilities | 382,910 | 0 |
Property and equipment purchases included in accounts payable and accrued expenses | $ 0 | $ 5,370 |
Description of the Business
Description of the Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of the Business | Description of the Business NexImmune, Inc. (the “Company” or “NexImmune”), a Delaware corporation headquartered in Gaithersburg, Maryland, was incorporated on June 7, 2011. The Company is an emerging biopharmaceutical company advancing a new generation of immunotherapies based on its proprietary Artificial Immune Modulation (AIM) technology. The AIM nanotechnology platform, originally developed at Johns Hopkins University, is the foundation for an innovative approach to immunotherapy in which the body’s own immune system is stimulated to orchestrate a targeted T cell response against a disease. Central to the AIM technology are artificial AIM nanoparticles, which act as synthetic dendritic cells. These AIM nanoparticles can be programmed to present specific antigens to specific T cells orchestrating a highly targeted immune response. These AIM nanoparticles can be rapidly engineered to elicit an immune attack that can be directed toward any foreign substance or cell type in a patient’s body. The Company’s first two products, both for the treatment of different types of cancer, entered clinical trials in 2020. Following a strategic review of the Company's corporate strategy, including with respect to its adoptive cell therapy programs, the Company paused investments in its cell therapy studies, NEXI-001, NEXI-002, and NEXI-003 which is designed to reduce costs and reallocate resources towards our AIM INJ preclinical development programs. As part of this strategy, the Company will focus on developing AIM INJ nanoparticle constructs and modalities for potential clinical evaluation in oncology and autoimmune disorders. The Company continues to explore several external opportunities to continue to advance these programs. As a result, the Company will focus its existing resources on its injectable platform in oncology and autoimmune diseases. Going Concern Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 205-40, Presentation of Financial Statements - Going Concern ("ASC 205-40"), requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. Under ASC 205-40, management has the responsibility to evaluate whether conditions and/or events raise substantial doubt about the Company’s ability to meet future financial obligations as they become due within one year after the date that the financial statements are issued. As required by this standard, management’s evaluation shall initially not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the financial statements are issued. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Since its inception, the Company has incurred recurring operating losses and negative cash flows from operations. The financial statements do not include any adjustments relating to the realization of the carrying value of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. As of December 31, 2023, the Company had an accumulated deficit of $222.6 million and negative cash flows from operating activities for the year ended December 31, 2023. The Company has no outstanding debt, $3.2 million in cash and cash equivalents as of December 31, 2023 and no other access to significant capital. The Company expects its negative cash flows from operating activities to exceed its currently available liquidity and thus has determined that its losses and negative cash flows from operations and uncertainty in obtaining additional liquidity to meet its obligations and sustain our operations raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the issuance date of these financial statements. As the Company’s research and development activities mature and develop over the next year, the Company will require substantial funds to continue such activities. As discussed below, as a result of the financing consummated in February 2024, the Company determined to postpone its previously scheduled special meeting of stockholders for the purpose of approving the liquidation and dissolution of the Company. If the Company is unable to raise additional capital or otherwise achieve other alternatives to maximize the value of the business and its assets, the Company would expect to call a new special meeting of stockholders to seek approval of the liquidation and dissolution of the Company. There are inherent uncertainties associated with fundraising activities which are not within the Company’s control. There are no assurances that such additional funding will be obtained, or that any funding that may be obtained would be sufficient for the Company to meet its obligations as they become due within one year, or that the Company will succeed in its future operations. If the Company cannot successfully raise additional capital, its liquidity, financial condition and business prospects will be materially and adversely affected. The Company is continually looking into further capital planning and the evaluation of strategic alternatives. There is substantial doubt about the Company’s ability to continue as a going concern. Reverse Stock Split On October 18, 2023, the Company effected a one-for-twenty-five (1-for-25) reverse stock split of its common stock (the “Reverse Stock Split”). The total authorized number of shares were not reduced. The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on October 17, 2023, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on October 18, 2023. The Reverse Stock Split was effective on October 18, 2023. All references to common stock, warrants to purchase common stock, options to purchase common stock, share data, per share data and related information contained in the financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented. Approval of Plan of Dissolution and Postponement of Special Meeting On November 2, 2023, the Board of Directors of the Company, or the Board, unanimously approved the liquidation and wind up of the Company through a dissolution pursuant to a plan of liquidation and dissolution, or the Plan of Liquidation and Dissolution, subject to stockholder approval, while continuing to pursue alternatives intended to maximize the value of the business and its assets. On February 2, 2024, the Company entered into a securities purchase agreement, or the “Purchase Agreement” with a single healthcare focused institutional investor, or the “Investor”, pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market, or the “Registered Offering”, (i) an aggregate of 117,000 shares, or the “Shares” of common stock, par value $0.0001, of the Company, or the “Common Stock”, at an offering price of $12.05 per share, and (ii) pre-funded warrants the “Pre-Funded Warrants” exercisable for up to 187,731 shares of Common Stock the “Pre-Funded Warrant Shares”, at an offering price of $12.049 per Pre-Funded Warrant, for aggregate gross proceeds from the offerings of approximately $3.7 million before deducting the placement agent fee and related offering expenses. The offerings closed February 6, 2024 and all Pre-Funded Warrants were exercised prior to March 1, 2024. As a result of the financing described above, the Company has determined to postpone its special meeting of stockholders for the purpose of approving the liquidation and dissolution of the Company and the Plan of Liquidation, which was previously scheduled to reconvene on Wednesday, February 7, 2024. |
Basis of Presentation and Liqui
Basis of Presentation and Liquidity | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Liquidity | Basis of Presentation and Liquidity Basis of Presentation The accompanying financial statements were prepared based on the accrual method of accounting in accordance with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the FASB. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of the 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 contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates, including those related to the recoverability of long-lived assets, stock-based compensation, the valuation of financial instruments, and the valuation of deferred tax assets and liabilities. The Company’s estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Although actual results could differ from those estimates, management does not believe that such differences would be material. Concentrations of credit risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and marketable debt securities. All cash is held in United States financial institutions that are federally insured. At times, the Company may maintain cash balances in excess of the federally insured amount. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. The Company’s investments in marketable debt securities have been issued by corporate entities and government-sponsored enterprises with high credit ratings. The Company mitigates investment risks by investing in highly-rated securities with relatively short maturities that the Company believes do not subject it to undue investment or credit risk. If any of these financial institutions fail to perform their obligations under the terms of these financial instruments, the Company’s maximum exposure to potential losses would be equal to the amounts reported on the balance sheet. Segment and Geographic Information Operating segments are defined as components of an entity 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 as and manages its business in one operating segment operating exclusively in the United States. 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. Marketable securities Marketable securities consist of debt securities with maturities greater than three months from the date of purchase that include commercial paper and corporate notes. Classification of marketable securities between current and non-current is dependent upon the maturity date at the balance sheet date taking into consideration the Company’s ability and intent to hold the investment to maturity. There were no outstanding marketable securities as of December 31, 2023 and 2022. Interest and dividend income are recorded when earned and included in interest income in the statement of operations. Premiums and discounts, if any, on marketable securities are amortized or accreted to maturity and included in interest income in the statement of operations. The specific identification method is used in computing realized gains and losses on the sale of the Company’s marketable securities. The Company classifies its marketable securities as available-for-sale. The Company determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. Marketable securities that are classified as available-for-sale are measured at fair value on the balance sheet, and unrealized gains and losses on marketable securities are reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit) until realized. Marketable securities are evaluated periodically to determine whether the carrying value of a marketable security exceeds its fair value and the decline in value is determined to be other-than-temporary. Management reviews criteria, such as the general market conditions, magnitude and duration in which the fair value has been less than the carrying value, the investment issuer’s financial condition and business outlook, as well as the Company’s ability to hold the securities until the recovery of its amortized cost basis, to determine whether the decline in value is other-than-temporary. If a decline in value is determined to be other-than-temporary, the value of the marketable security is reduced, and the impairment is recorded as other expense in the statement of operations. As of December 31, 2022, any decline in value of marketable securities was concluded not to be other-than-temporary. As of December 31, 2023, no assessment was required. Restricted cash The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the statement of cash flows. December 31, 2023 2022 Cash and cash equivalents $ 3,202,452 $ 34,642,340 Restricted cash 20,000 55,000 Total $ 3,222,452 $ 34,697,340 Amounts included in restricted cash represent amounts required as collateral on corporate credit cards. Fair value measurements The Company’s financial instruments include cash and cash equivalents, marketable securities, accounts payable, and accrued expenses. The fair values of the cash and cash equivalents, accounts payable and accrued expenses approximated their carrying values as of December 31, 2023 and 2022, due to their short-term maturities. For a description of the fair value of marketable securities, refer to Note 4. The Company accounts for recurring and nonrecurring fair value measurements in accordance with ASC 820, Fair Value Measurements (“ASC 820”). 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 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 judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC 820 hierarchy. Property and equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Major replacements and improvements that extend the useful lives of assets are capitalized, while general repairs and maintenance are charged to expense as incurred. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the estimated useful lives of the assets or the related lease term, whichever is shorter. Upon retirement or disposal, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is recognized within operating expenses. The estimated useful lives of property, plant and equipment by major category are as follows: Estimated Useful Life Laboratory equipment 7 years Computer equipment and software 3 years Furniture and fixtures 7 years Leasehold Improvements Shorter of lease term or useful life Impairment of long-lived assets The Company evaluates the carrying value of its long-lived asset group for potential impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability is determined by comparing future undiscounted cash flows associated with such assets to the related carrying value. An impairment loss may be recognized when the estimated undiscounted future cash flow is less than the carrying amount of the asset. If these cash flows are less than the carrying value of such asset group, the Company then determines the fair value of the underlying asset group. Any impairment loss to be recognized is measured as the amount by which the carrying value of the asset group exceeds the fair value of the asset group. Based on the analysis performed by management, the Company expensed $0.1 million of property and equipment as impaired as of December 31, 2023 to other expense Loss on assets held for sale Loss on assets held for sale is the difference between the asset’s estimated fair value less estimated costs to sell and the asset’s book value at the time the asset is no longer used for operations and reclassified as held for sale in accordance with the held-for-sale criteria. Research and development Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including share-based compensation, as well as costs for third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, based on its estimates of services performed and costs incurred. These estimates include the level of services performed by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expenses in future periods as the related services are rendered. Clinical trial and contract development and manufacturing organization expenses The Company makes payments in connection with clinical trials and contract development and manufacturing organizations (“CDMO”) under contracts with contract research organizations that support conducting and managing clinical trials and the manufacturing of materials utilized in clinical and preclinical activities. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of the obligation to make payments under these contracts depends on factors such as the successful enrollment, treatment of patients, the completion of other clinical trial milestones, or completion of manufacturing milestones. Termination clauses within the agreements require notification for a certain number of days prior to completing work, payments for costs incurred through the termination date, and termination penalty, if applicable. Expenses related to clinical trials are accrued based on estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. Expenses related to development and manufacturing are accrued based on estimates and/or representations from service providers regarding work performed, including progress in the development of processes through technology transfers to manufacture the Company’s clinical material and completion of the manufactured clinical material. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts the Company is obligated to pay under clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the accruals are adjusted accordingly. Revisions to contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. Stock-based compensation The Company records compensation expense associated with stock options and other forms of equity compensation based on the estimated fair value at the grant date. Compensation expense related to awards to employees and non-employees with service based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the requisite service period of the award, which is generally the vesting term. The Company’s policy is to account for forfeitures as they occur. The Company uses the Black-Scholes-Merton option pricing, or Black-Scholes, model to estimate the fair value of stock options. The Black-Scholes model requires input-based assumptions that are highly subjective, judgmental and sensitive in the determination of stock-based compensation cost. Options granted after the Company’s Initial Public Offering, or IPO, are issued at the fair market value of the Company’s common stock at the date the grant is approved by the Board of Directors. Expected volatility —The expected volatility was based on the historical volatility of comparable public companies from a representative peer group selected based on industry and market capitalization data. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. Risk-free interest rate —The risk-free interest rate was based on the continuous rates provided by the U.S. Treasury with a term approximating the expected term of the option. Expected dividend yield —The expected dividend yield was 0% because the Company has not historically paid and does not expect to pay any dividends for the foreseeable future. Expected term —The Company uses the simplified method as prescribed by the Securities and Exchange Commission, or the SEC, Staff Accounting Bulletin No. 107, Share-Based-Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. See Note 12 for a further discussion on stock-based compensation. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax expense or benefit is the result of changes in deferred tax assets and liabilities. Valuation allowances are established when necessary to reduce deferred tax assets where, based upon the available evidence, the Company concludes it is more-likely-than-not that the deferred tax assets will not be realized. In evaluating its ability to recover deferred tax assets, the Company considers all available positive and negative evidence, including its operating results, on-going tax planning and forecasts of future taxable income on a jurisdiction-by-jurisdiction basis. The Company recorded a valuation allowance against all estimated net deferred tax assets as of December 31, 2023 and 2022. Liabilities are provided for tax benefits for which realization is uncertain. Such benefits are only recognized when the underlying tax position is considered more-likely-than-not to be sustained on examination by a taxing authority, assuming they possess full knowledge of the position and facts. Recognized income tax positions are measured at the largest amount that is greater than more-likely-than-not of being realized. Changes in the recognition or measurement are reflected in the period in which the change in estimate occurs. Interest and penalties related to uncertain tax positions are recorded in the provision of income taxes. There were no uncertain tax positions nor income tax related interest and penalties recorded as of or for the years ended December 31, 2023 and 2022. Net Loss Per Share Attributable to Common Stockholders Basic net loss per common share is determined by dividing net loss attributable to common stockholders 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 attributable to common stockholders by the weighted-average number of common stock and common stock equivalents outstanding for the period. The Company adjusts net loss to arrive at the net loss attributable to common stockholders to reflect the amount of dividends accumulated during the period on the Company’s redeemable convertible preferred stock. Such dividends are only payable if and when declared by the Board of Directors (Note 11). The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants. For the years ended December 31, 2023 and 2022, the Company had a net loss attributable to common stockholders, and as such, all outstanding stock options and RSUs were excluded from the calculation of diluted loss per share. The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2023 and 2022: 2023 2022 Net loss $ (32,344,393) $ (62,506,199) Net loss attributable to common stockholders $ (32,344,393) $ (62,506,199) Basic and diluted net loss per common share $ (30.82) $ (64.95) Basic and diluted weighted average common shares outstanding 1,049,468 962,364 The following potentially dilutive securities have been excluded from the computation of diluted weighted average common shares outstanding at December 31, 2023 and 2022, as the effect would be anti-dilutive: 2023 2022 Stock options 130,526 158,620 Restricted stock units 26,460 62,320 Total 156,986 220,940 Emerging growth company status The Company is an “emerging growth company” (EGC), as defined in the Jumpstart Our Business Startups Act (JOBS Act), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act, which provides that an EGC can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, the financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of an IPO offering or such earlier time that it is no longer an EGC. Recent accounting standards and pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) ("ASU 2016-13"), which modifies the measurement of expected credit losses on certain financial instruments. In addition, for available-for-sale debt securities, the standard eliminates the concept of other-than-temporary impairment and requires the recognition of an allowance for credit losses rather than reductions in the amortized cost of the securities. The standard is effective for fiscal year beginning after December 15, 2022 and interim periods beginning after December 15, 2022 and requires a modified-retrospective approach with a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period. Early adoption is permitted. Based on the composition of the Company’s investment portfolio, current market conditions and historical credit loss activity, the adoption of ASU 2016-13 did not have a material impact on the Company’s financial position, results of operations or the related disclosures. The Company adopted the new guidance on January 1, 2023 and determined there was no impact. Not Yet Adopted In October 2023, the FASB issued ASU 2023-06—Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, to clarify or improve disclosure and presentation requirements of a variety of Topics. ASU 2023-06 adds 14 of the 27 identified disclosure or presentation requirements to the Codification. However, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation requirement from its existing regulations by June 30, 2027. The effective dates of ASU 2023-06 will depend, in part, on whether an entity is already subject to the SEC’s current disclosure requirements. For such entities and those that must “file or furnish financial statements with or to the SEC in preparation for the sale of or for purposes of issuing securities that are not subject to contractual restrictions on transfer,” the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. For all other entities, the amendments will be effective two years after the date of such removal. The Company is currently assessing the effect of this ASU on its financial statements and related disclosures. In November 2023, the FASB issued ASU 2023-07—Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, to improve the disclosures about a public entity’s reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses. All public entities will be required to report segment information in accordance with the new guidance starting in annual periods beginning after December 15, 2023. The Company plans to adopt the ASU for the fiscal year beginning January 1, 2024. Since the Company has only one reportable segment, the Company will need to disclose the title and position of the chief operating decision maker (“CODM”) and an explanation of how the CODM uses the reported measures of segment profit or loss in assessing segment performance and deciding how to allocate resources, as well as disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the CODM. The Company is currently assessing the effect of this ASU on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information as well as certain other amendments to improve the effectiveness of income tax disclosures. The amendments in this update are effective for annual periods beginning after December 15, 2024. The Company does not expect adoption of this ASU to have a material impact on its results of operations, financial condition, and its financial statements other than adding new disclosures, which the Company is currently evaluating, as the Company has not recorded any net tax provision for the periods presented due to the losses incurred and the need for a full valuation allowance on net deferred tax assets. Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s financial statements and related disclosures upon adoption. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following table represents the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis: December 31, 2023 December 31, 2022 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Assets Money market funds $ 23,270 $ — $ — $ 23,722,328 $ — $ — Fixed income debt securities $ — $ — $ — $ — $ 7,979,279 $ — $ 23,270 $ — $ — $ 23,722,328 $ 7,979,279 $ — |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following at December 31, 2023 and 2022: 2023 2022 Prepaid research and development expenses $ 115,353 $ 1,176,491 Prepaid maintenance agreements — 369,606 Prepaid insurance 368,048 403,653 Prepaid other 35,817 245,278 Interest receivable — 74,467 Other current assets 215,246 401,916 $ 734,464 $ 2,671,411 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment In November 2023, the Company terminated its primary lease and began moving equipment from its facility to be sold. The Company considered the criteria to classify the property and equipment as held for sale under ASC 360—Property, plant and equipment (Topic 360). Assets shall be classified as held for sale in the period in which all of the following criteria are met: a) Management commits to a plan to sell the entity to be sold. b) The assets to be sold are available for immediate sale in its present condition. c) An active program to locate a buyer or buyers is in place. d) The sale is probable, and is expected to be completed within one year. e) The assets to be sold being actively marketed for sale at a price that is reasonable in relation to its current fair value. f) Actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or that the plan will be withdrawn. The Company determined that all these criteria as of December 31, 2023 were met for certain categories of the property and equipment, specifically certain computers and laboratory equipment. Accordingly, the computers and laboratory equipment being sold were classified as current assets held for sale at December 31, 2023. See Note 7 for discussion on the Assets Held for Sale. Property and equipment consist of the following at December 31, 2023 and 2022: 2023 2022 Laboratory equipment $ 2,668,280 $ 6,803,996 Computer equipment and software 202,963 516,974 Furniture and fixtures — 47,877 Leasehold improvements 36,459 319,816 2,907,702 7,688,663 Less accumulated depreciation and amortization (1,554,801) (3,229,592) Property and equipment, net $ 1,352,901 $ 4,459,071 Depreciation and amortization expense was $1.0 million for both years ended December 31, 2023 and 2022, respectively. |
Assets Held For Sale
Assets Held For Sale | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Assets Held For Sale | Assets Held For Sale On November 29, 2023, the Company and AFAB Lab Resources, LLC (“AFAB”) initiated an asset sales agreement, pursuant to which AFAB would sell certain computers and laboratory equipment. According to Topic 360, the Company determined that the criterion to classify the certain computers and laboratory equipment as assets held for sale within the Company’s balance sheet effective as of December 31, 2023 were met. Accordingly, the assets were classified as current assets held for sale as of December 31, 2023 as the Company, at that time, expected to sell these assets within the next twelve months. The classification to assets held for sale impacted the net book value of the assets expected to be transferred upon sale. The estimated fair value of the computers and laboratory equipment was determined using the purchase price in the purchase agreement along with estimated broker, accounting, legal, and other selling expenses, which resulted in the lower of the carrying value and the fair value less costs to sell of approximately $1.4 million. The carrying value of the assets being classified as held for sale was approximately $2.0 million. As a result, the Company recorded a loss on assets held for sale of $0.7 million. Upon completion of the computers and laboratory equipment sales, the Company could record an additional gain or loss on disposal at the time final net proceeds are determined. Additionally, the expected sale of assets held for sale was not deemed to represent a fundamental strategic shift that would have a major effect on the Company’s operations, and accordingly, it was not reported as discontinued operations in the Company’s statement of operations for the year ended December 31, 2023. |
Restructuring Activities
Restructuring Activities | 12 Months Ended |
Dec. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Activities | Restructuring Activities In November 2022, the Company announced that, following a strategic review of its pipeline, indications, timelines and cash position, it implemented a strategic realignment initiative, which was designed to reduce costs and reallocate resources towards its AIM INJ preclinical development programs. As part of this strategy, the Company initiated a workforce reduction plan to reduce headcount by 30%, primarily affecting the clinical development, manufacturing and administrative staff that had been needed to support the AIM ACT adoptive cell therapy clinical programs. This plan reduced the Company’s workforce from 74 full-time employees to approximately 50 full-time employees. The Company incurred approximately $0.7 million of costs in connection with the reduction in workforce related to severance pay and other related termination benefits. These one-time employee termination benefits are comprised of severance, benefits and related costs, all of which are resulted in cash expenditures. In August and October 2023, the Company announced that, in order to reduce its cash expenditures while continuing to pursue its existing strategic plan, its Board of Directors approved and its management is implementing a reduction in workforce, designed to reduce costs and extend the Company’s cash. The realignment reduced the Company’s workforce from 44 to 6 full-time employees. The Company incurred $3.1 million of costs in connection with the reductions in workforce related to severance pay and other related termination benefits. These one-time employee termination benefits are comprised of severance, benefits and related costs, and are recorded to research and development and general administrative expenses, all of which are expected to result in cash expenditures. The Company expects that the implementation of the reduction-in-force will be substantially complete in September 2024. Accrued salaries at December 31, 2022 includes $0.4 million in severance expenses related to the November 2022 restructuring. The Company communicated the workforce reduction on November 14, 2022 and recognized $0.5 million in costs associated with the restructuring during the year ended December 31, 2022. The Company completed these restructuring in the second quarter of 2023. The following table summarizes the charges related to the restructuring activities as of December 31, 2023 and December 31, 2022. Accrued Restructuring Expenses Accrued Restructuring Expenses December 31, 2022 Expenses Less: Payments December 31, 2023 Severance, benefits and related costs due to workforce reduction $ 382,389 $ 3,090,371 $ (3,206,223) $ 266,537 Totals $ 382,389 $ 3,090,371 $ (3,206,223) $ 266,537 Accrued Restructuring Expenses Accrued Restructuring Expenses December 31, 2021 Expenses Less: Payments December 31, 2022 Severance, benefits and related costs due to workforce reduction $ — $ 531,829 $ (149,440) $ 382,389 Totals $ — $ 531,829 $ (149,440) $ 382,389 |
Accrued Expenses and other curr
Accrued Expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and other current liabilities | Accrued Expenses and other current liabilities A summary of the components of accrued expenses is as follows as of December 31, 2023 and 2022: 2023 2022 Accrued research and development costs $ 3,148,021 $ 3,210,794 Accrued professional fees 131,226 267,383 Accrued salaries, benefits and related expenses 389,858 3,855,797 Other accrued expenses and other current liabilities 10,000 23,179 Total $ 3,679,105 $ 7,357,153 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies The Company entered into a Translational Research Award Agreement effective May 23, 2012 with the Department of Business & Economic Development with the State of Maryland, Maryland Biotechnology Center (“MBC”). The mission of MBC is to integrate entrepreneurial strategies to stimulate the transformation of scientific discovery and intellectual assets into capital formation and business development. Under the agreement, MBC provided $200,000 to NexImmune for research on its artificial aAPC for cancer immunotherapy. In 2013, an amendment increased the amount by $125,000 for a total grant of $325,000. This grant was recorded as income in 2012 and 2013, as the Company incurred the expenses which qualified it for the grant. The Company must repay the funds through annual payments calculated at 3% of annual revenues for the preceding year. Payments shall continue for 10 years after the first payment date and may total up to 200% of the total grant amount. The end date of the agreement is defined as January 31, 2024, or when any and all repayments due to MBC have been made. If the Company does not earn any revenue, the grant does not need to be repaid. Through December 31, 2023, no revenue has been recorded, therefore, no payments to MBC are due. Johns Hopkins University Exclusive License Agreement The Company entered into an Exclusive License Agreement with Johns Hopkins University (“JHU”) effective June 2011, which was amended and restated in January 2017, referred to as the A&R JHU License Agreement, under which there are license fees, royalties, and milestone payments. As part of the agreement, the Company acquired a perpetual, exclusive license from JHU covering its invention related to Antigen Specific T cells. JHU was also entitled to milestone fees of $75,000 in connection with clinical trial milestones. For the first licensed product or licensed service in the therapeutic field, the Company may be required to pay JHU additional aggregate milestone fees of $1.6 million for clinical and regulatory milestone fees. The Company may be required to pay JHU reduced milestone fees for the second and third licensed products or licensed services in the therapeutic field in connection with clinical and regulatory milestones. In the diagnostic field, the Company may be required to pay JHU aggregate milestone fees of $0.4 million for the first licensed product or licensed service and reduced milestone fees for the second and third licensed products or licensed services in connection with regulatory and commercial milestones. The Company may be required to pay JHU aggregate milestone fees of $100,000 for commercial milestones for the first licensed product or licensed service in the non-clinical field. In the aggregate, the Company may be required to pay JHU additional milestone fees of up to $4.2 million for all clinical, regulatory and commercial milestones for all licensed products or licensed services in the therapeutic field, the diagnostic field and the non-clinical field. The Company may also be required to pay royalties in the low to upper single digits on net sales of licensed services in therapeutic products, diagnostic products and non-clinical products. The Company is required to make minimum annual royalty payments of $100,000 to JHU under the A&R JHU License Agreement, which started in the low five figures in the first year of the agreement and increased to $100,000 in the third year and for each subsequent year of the agreement. The Company may also be required to pay JHU a low double digit percentage, not to exceed 15%, of any non-royalty sublicense consideration the Company receives. The Company will record a liability when such events become probable. The Company has not reached any of the milestones or transacted its first commercial sale as of December 31, 2023. The Company must make minimum royalty payments, which began upon the fourth anniversary of the agreement and upon every anniversary thereafter during the term of the agreement, which offset future royalties per above owed to JHU. The Company has incurred $625,000 in cumulative minimum royalties from inception. Future annual minimum royalties consist of $100,000 due each year during the remaining term of the agreement. The Company records milestones, royalties and minimum royalties at the time when payments become probable. The Company incurred $100,000 related to minimum royalties owed in the years ended December 31, 2023 and 2022 and is included in research and development expenses on the accompanying statement of operations. The Company has accrued royalties of $50,000 as of December 31, 2023 and 2022. Contingencies From time to time, the Company may be subject to various litigation and related matters arising in the ordinary course of business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred and the amount can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. As of December 31, 2023 and 2022, the Company was not involved in any material legal proceedings. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Redeemable Convertible Preferred Stock And Stockholders Equity Disclosure [Abstract] | |
Stockholders' Equity | Stockholders’ Equity The Company had 250,000,000 authorized shares of common stock, par value $0.0001 per share, of which 1,066,320 and 1,043,138 shares were issued and outstanding at December 31, 2023 and 2022, respectively. Issuances of Common Stock On March 9, 2022, the Company filed a shelf registration statement on Form S-3, or the Form S-3, with the SEC pursuant to which we disclosed that we may offer and sell, from time to time in one or more offerings, any combination of common stock, preferred stock, debt securities, warrants, rights or units having a maximum aggregate offering price of $200 million. On June 17, 2022, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and BTIG, LLC (together, the “Agents”), pursuant to which the Company may offer and sell shares of its common stock, $0.0001 par value per share, having an aggregate offering price of up to $50.0 million (the "Shares") from time to time through the Agents (the "Offering"). Subject to the terms and conditions of the Sales Agreement, any such sales made through the Agents can be made, based upon the Company's instructions, by methods deemed an “at-the-market” offering as defined in Rule 415(a)(4) promulgated under the Securities Act. The Company agreed to pay the Agents a commission of 3.0% of the gross proceeds of any sales of shares sold pursuant to the Sales Agreement. During the year ended December 31, 2022, the Company sold an aggregate of 127,396 shares through our “at-the-market” offering facility resulting in net proceeds of $5.1 million. No sales were transacted for the year ended December 31, 2023. On February 2, 2024, the Company and each of the Agents mutually agreed to terminate the Sales Agreement effective immediately. The Company did not incur any material early termination penalties in connection with the termination of the Sales Agreement. On February 2, 2024, the Company and each of the Agents mutually agreed to terminate the Sales Agreement and the ATM Program effective immediately. The Company did not incur any material early termination penalties in connection with the termination of the Sales Agreement. On February 2, 2024, the Company, entered into a securities purchase agreement (the “Purchase Agreement”) with a single healthcare focused institutional investor (the “Investor”), pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market (the “Registered Offering”), (i) an aggregate of 117,000 shares (the “Shares”) of common stock, par value $0.0001, of the Company (the “Common Stock”), at an offering price of $12.05 per share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) exercisable for up to 187,731 shares of Common Stock (the “Pre-Funded Warrant Shares”), at an offering price of $12.049 per Pre-Funded Warrant, for aggregate gross proceeds from the Offerings (as defined below) of approximately $3.7 million before deducting the placement agent fee (as described in greater detail below) and related offering expenses. The closing of the Offerings is expected to occur on or about February 6, 2024, subject to the satisfaction of customary closing conditions. The shares of Common Stock and Pre-Funded Warrants (and shares of common stock underlying the Pre-Funded Warrants) were offered by the Company pursuant to its shelf registration statement on Form S-3 (File No. 333-263399), which was filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2022 and declared effective by the SEC on March 16, 2022 (“Registration Statement”), including the base prospectus contained therein, and a related prospectus supplement, dated February 2, 2024, filed with the SEC on February 5, 2024. In a concurrent private placement (the “Private Placement” and, together with the Registered Offering, the “Offerings”), the Company issued to the Investor unregistered warrants to purchase up to an aggregate of 304,731 shares of Common Stock (the “Unregistered Warrants”) at an exercise price of $12.05 per share. Each Unregistered Warrant is exercisable immediately and will expire two years from the initial exercise date. The Unregistered Warrants and the shares of our Common Stock issuable upon the exercise of the Unregistered Warrants are not being registered under the Securities Act of 1933, as amended (the “Securities Act”), are not being offered pursuant to the Registration Statement and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act, and/or Rule 506(b) promulgated thereunder. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation During January 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”), which provides for granting of restricted stock, options to purchase shares of common stock and other awards to employees, directors and consultants. In March 2017, the Company amended the 2017 Plan to increase the number of available shares to 26,433. In September 2018, the Company adopted the 2018 Equity Incentive Plan (the “2018 Plan”) which provides for granting of restricted stock, options to purchase shares of common stock, and other awards to employees, directors and consultants, and reserved 69,670 shares for this purpose. The 2018 Plan was amended in July 2018 to increase the number of available shares to 72,365. In February 2021, the Company adopted the 2021 Equity Incentive Plan (“2021 Plan”) and reserved 110,302 shares under the plan. No further shares will be issued under the 2017 and 2018 plans. In addition, the 2021 Plan contains an “evergreen” provision, which allows for an annual increase in the number of shares of our common stock available for issuance under the 2021 Plan on the first day of each calendar year beginning in calendar year 2022. The annual increase in the number of shares shall be equal to the lower of (i) 5.0% of the number of shares of our common stock outstanding on the date of the applicable increase or (ii) a lesser amount determined by our board of directors. Following the annual increase in the number of shares of our common stock available for issuance under the 2021 Plan, there are 152,533 shares available for issuance under the 2021 plan as of March 1, 2024. The number of options to be granted under the 2021 Plan, the option exercise prices, and other terms of the options are determined by the Board of Directors in accordance with the terms of the 2021 Plan. Generally, stock options are granted at fair value, become exercisable over a period of one On March 22, 2023, in order to retain and motivate employees and other key contributors of the Company, the Board approved a one-time stock option repricing, or the Option Repricing. Pursuant to the Option Repricing, the exercise price of all of the below stock options to purchase shares of the Company’s common stock previously granted under our 2017 Plan, 2018 Plan and 2021 Plan, or the Repriced Options, was amended as of April 4, 2023 or the Effective Date, to reduce the exercise prices of such options to a price equal to or greater than the closing price per share of the Company’s common stock on The Nasdaq Stock Market on the Effective Date, which was $0.41 per share, or the “Nasdaq Market Price”, on the terms described below: Repriced Options Terms of Repriced Options vested or vesting within six months following the Effective Date Terms of Repriced Options vesting more than six months following the Effective Date All options held by employees other than our executive officers, in good standing on the Effective Date The Option Repricing exercise price will be equal to 2.5 times the Nasdaq Market Price, or $25.75 The Option Repricing exercise price will be equal to the Nasdaq Market Price, or $10.25. All options held by our current executive officers and 100,000 options held by Jerome Zeldis, our former Executive Vice President and Head of Research & Development The Option Repricing exercise price will be equal to 3.0 times the Nasdaq Market Price, or $30.75. The Option Repricing exercise price will be equal to 2.0 times the Nasdaq Market Price, or $20.50. All options held by our directors The Option Repricing exercise price will be equal to 4.0 times the Nasdaq Market Price, or $41.00. The Option Repricing exercise price will be equal to 3.0 times the Nasdaq Market Price, $30.75. The Company treated the Option Repricing as a modification to the original stock option grant because the terms of the agreements were modified. The total number of options issued and outstanding were not impacted by the Option Repricing. The calculation of the incremental compensation expense is based on the excess of the fair value of the award measured immediately before and after the modification. The total incremental expense calculated to be recognized over the service period is $0.3 million. As a result, the Company recognized an incremental compensation expense for vested shares $0.2 million associated with the modification arising from the Option Repricing for the year ended December 31, 2023. Stock-based compensation expense was recorded in the following financial statement line items within the statement of operations for the years ended December 31, 2023 and 2022: 2023 2022 Research and development expenses $ 1,133,428 $ 3,812,441 General and administrative expenses 2,420,198 2,057,923 Total stock-based compensation expense $ 3,553,626 $ 5,870,364 As a result of the August and November 2023 reduction in force actions, certain executives' options accelerated vesting that resulted in an expense of $0.6 million for the year ended December 31, 2023. The following is a summary of option activity under the Company’s Stock Option Plans: Stock Weighted Weighted Aggregate Outstanding as of January 1, 2023 158,620 $ 184.51 8.0 $ — Granted 46,644 9.44 Exercised — — Cancelled (53,271) 172.1 Forfeited (21,467) 61.18 Outstanding as of December 31, 2023 130,526 $ 28.64 7.3 $ — Vested or expected to vest as of December 31, 2023 130,526 $ 28.64 7.3 $ — Exercisable as of December 31, 2023 78,536 $ 38.73 6.3 $ — Shares unvested as of December 31, 2023 52,030 $ 13.95 8.9 $ — The weighted average fair value of the options granted during the years ended December 31, 2023 and 2022 was $7.17 and $60.50, respectively. The options were valued using the Black-Scholes option-pricing model for the years ended December 31, 2023 and 2022 with the following assumptions: 2023 2022 Expected volatility 90.2% to 93.7% 78.6% to 83.2% Risk-free interest rate 3.4% to 4.20% 1.5% to 3.80% Expected dividend yield 0% 0% Expected term 5.5 to 6.1 years 5.5 to 6.1 years The total fair value of stock options vested during the years ended December 31, 2023 and 2022 was $2.2 million, and $9.2 million, respectively. The intrinsic value of stock options exercised for the years ended December 31, 2023 and 2022 was approximately zero and $0.2 million, respectively. As of December 31, 2023, there was $1.9 million of total unrecognized compensation expense related to unvested options that will be recognized over a weighted average period of 1.9 years. Restricted Stock Units A restricted stock unit, or RSU, represents the right to receive one of the Company’s common stock upon vesting of the RSU. The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant. The following is a summary of RSU activity for the 2021 Plan for the year ended December 31, 2023: Number of restricted units Weighted average grant date fair value Unvested and outstanding at January 1, 2023 62,320 $ 11.30 Granted — — Settled (31,044) 11.25 Forfeited (4,816) 11.25 Unvested and outstanding as of December 31, 2023 26,460 $ 11.36 As of December 31, 2023, there was $0.1 million of unrecognized compensation expense related to unvested RSUs, which are expected to be recognized over a weighted average period of 0.4 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company’s provision for income taxes consists of the following for the years ended December 31, 2023 and 2022: 2023 2022 Current income tax provision: Federal $ — $ — State — — Total — — Deferred income tax benefit: Federal 4,967,519 12,339,546 State 15,852 (7,370,113) Total 4,983,371 4,969,433 Change in valuation allowance (4,983,371) (4,969,433) Total provision (benefit) for income taxes $ — $ — A reconciliation of the statutory U.S. income tax rate to the effective income tax rate as of December 31, 2023 and 2022 is as follows: 2023 2022 U.S. Federal statutory rate 21.00 % 21.00 % State taxes 0.20 % 0.17 % Permanent differences (0.89) % (0.58) % Other adjustments (4.81) % (0.02) % Change in state tax rate 0.01 % (12.61) % Change in valuation allowance (15.51) % (7.96) % Provision for income taxes 0.00 % 0.00 % The significant components of the Company’s deferred tax assets (liabilities) as of December 31, 2023 and 2022 were as follows: 2023 2022 Deferred tax assets: Net operating loss carryforward $ 32,486,609 $ 28,477,866 Accrued compensation 542,591 575,883 Stock compensation 825,801 1,913,771 Research and development credits 291,022 291,022 Capitalized research and development costs 9,826,015 7,838,512 Operating leases 14,587 216,925 Other 2,025 2,022 Gross deferred income tax assets 43,988,650 39,316,001 Less: Valuation allowance (43,840,838) (38,857,468) Total deferred income tax assets 147,812 458,533 Deferred tax liabilities: ROU assets (9,903) (204,694) Depreciation and amortization (137,909) (253,839) Total deferred tax liabilities (147,812) (458,533) Net deferred tax assets $ — $ — At December 31, 2023 and 2022, the Company had net operating loss (NOL) carryforwards for income tax purposes of approximately $154.3 million and $135.2 million, respectively, which are available to offset future federal taxable income, if any. Approximately $10.5 million of the federal NOL was generated prior to 2018 and will be expiring in increments through 2037 beginning in 2035, while the remaining $143.8 million will be carried forward indefinitely, with a limitation of 80% of taxable income. The state NOL will expire in increments through 2037, beginning in 2035. The federal research and development tax credit carryforwards, if not utilized, will expire beginning in 2037. Section 382 of the Internal Revenue Code imposes substantial restrictions on the utilization of net operating losses and Section 383 of the Internal Revenue Code imposes restrictions on the utilization of tax credits in the event of a corporations’ ownership change. The Company believes that the future use of net operating losses and tax credits presented above may be limited as a result of past ownership changes and a formal study has not yet been completed. The Company recognizes the effect of income tax positions only if those positions more likely than not of being sustained. At December 31, 2023, the Company had no gross unrecognized tax benefits and did not recognize any interest or penalties related to uncertain tax positions. At December 31, 2023, the Company provided a 100% valuation allowance on its net deferred tax assets because realization of any future tax benefit cannot be reasonably assured. The Company’s valuation allowance increased due to the pre-tax losses generated in the current year. The Company is subject to income taxation by both federal and state taxing authorities. Due to the net operating loss and tax credit carryforward, tax years 2015 through 2023 remain open to examination by the major taxing jurisdictions to which the Company is subject. There are no open examinations that would have a meaningful impact to the consolidated financial statements. Under the Tax Cuts and Jobs Act of 2017, research and development costs are no longer fully deductible and are required to be capitalized and amortized for US Tax purposes over five or fifteen years effective January 1, 2022. The mandatory capitalization requirement increased our deferred tax assets as of December 31, 2023 and 2022. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | Leases The Company leases certain office space and laboratory space. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company does not recognize right-of-use assets or lease liabilities for leases determined to have a term of 12 months or less. Options to extend a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. At the lease commencement date, the operating lease liability is recorded at the present value of future lease payments over the expected remaining lease term using the discount rate implicit in the lease, if it is readily determinable, or the Company’s incremental borrowing rate. The right-of-use asset is measured as the lease liability and adjusted for prepaid rent, initial direct costs, and incentives. The Company's leases contain variable non-lease components such as maintenance, taxes, insurance, and similar costs for the spaces it occupies. For new and amended leases beginning in 2022 and after, the Company has elected the practical expedient not to separate these non-lease components of leases for classes of all underlying assets and instead account for them as a single lease component for all leases. The Company recognizes the net fixed payments of operating leases on a straight-line basis over the lease term. Variable executory costs, as it relates to net leases, are to be excluded from the calculation of the lease liability and the Company expenses the variable lease payments in the period in which it incurs the obligation to pay such variable amounts and will be included in variable lease costs in the leases footnote disclosure. On November 1, 2023, the Company terminated its lease at 9119 Gaither Rd., Gaithersburg, Maryland. The termination date is January 31, 2024. Management accounted for this change to the lease as a lease modification that shortens the lease term. The effect of the modification as of December 31, 2023 was $0.4 million. Variable lease payments are not included in the Company's calculation of its right-of-use assets or lease liabilities. Variable lease costs were immaterial for the year ended December 31, 2023. The components of lease cost under ASC 842 for the year ended December 31, 2023 are as follows: Lease costs Statement of Operations Classification December 31, 2023 December 31, 2022 Operating lease cost Operating expenses: research and development $ 331,215 $ 379,288 Operating lease cost Operating expenses: general and administrative 228,354 207,401 $ 559,569 $ 586,689 Supplemental disclosure of cash flow information and weighted average remaining lease term and discount rate related to leases were as follows: Other information December 31, 2023 December 31, 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (617,999) $ (584,429) Right-of-use assets in exchange for operating lease liabilities $ (382,910) $ — Weighted-average remaining lease term — operating leases 0.1 years 1.8 years Weighted-average discount rate — operating leases 6.7 % 6.8 % Future fixed lease payments for operating leases in effect as of December 31, 2023, are payable as follows: Maturity of lease liabilities for the years ending December 31, Operating Leases 2024 $ 68,898 2025 — 2026 — 2027 — 2028 — Thereafter — Total lease payment $ 68,898 Less: imputed interest (89) Present value of lease liabilities $ 68,809 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions On March 16, 2022, the Company and Zephyr AI, Inc. (“Zephyr”) entered into a Joint Research Agreement (the “JRA”) focused on the joint collaboration, identification and validation of certain targets in order to facilitate further research, development and potential commercialization of immunotherapies. Zephyr is owned by a holding company with multiple Board members from the Company. The JRA term is two years unless mutually extended. As of March 16, 2024, neither party extended the JRA and the JRA is terminated. The expenses related to the JRA for the year ended December 31, 2023 and 2022 were not material. Beginning in June 2022, the Company entered into a series of statement of works with the Center for Discovery & Innovation at Hackensack Meridian Health ("CDI") to enhance the Company's AIM platform. The Chairman of the Board of CDI is a Board member. The total value of the statement of works through July 31, 2023 is $0.2 million. The expenses incurred to the CDI for the years ended December 31, 2023 and 2022 was $0.1 million and $40,000, respectively. The Company has recorded a $25,000 accrual as of December 31, 2023. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Not applicable |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net loss | $ (32,344,393) | $ (62,506,199) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Going Concern | Going Concern Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 205-40, Presentation of Financial Statements - Going Concern ("ASC 205-40"), requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. Under ASC 205-40, management has the responsibility to evaluate whether conditions and/or events raise substantial doubt about the Company’s ability to meet future financial obligations as they become due within one year after the date that the financial statements are issued. As required by this standard, management’s evaluation shall initially not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the financial statements are issued. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Since its inception, the Company has incurred recurring operating losses and negative cash flows from operations. The financial statements do not include any adjustments relating to the realization of the carrying value of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. As of December 31, 2023, the Company had an accumulated deficit of $222.6 million and negative cash flows from operating activities for the year ended December 31, 2023. The Company has no outstanding debt, $3.2 million in cash and cash equivalents as of December 31, 2023 and no other access to significant capital. The Company expects its negative cash flows from operating activities to exceed its currently available liquidity and thus has determined that its losses and negative cash flows from operations and uncertainty in obtaining additional liquidity to meet its obligations and sustain our operations raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the issuance date of these financial statements. As the Company’s research and development activities mature and develop over the next year, the Company will require substantial funds to continue such activities. As discussed below, as a result of the financing consummated in February 2024, the Company determined to postpone its previously scheduled special meeting of stockholders for the purpose of approving the liquidation and dissolution of the Company. If the Company is unable to raise additional capital or otherwise achieve other alternatives to maximize the value of the business and its assets, the Company would expect to call a new special meeting of stockholders to seek approval of the liquidation and dissolution of the Company. There are inherent uncertainties associated with fundraising activities which are not within the Company’s control. There are no assurances that such additional funding will be obtained, or that any funding that may be obtained would be sufficient for the Company to meet its obligations as they become due within one year, or that the Company will succeed in its future operations. If the Company cannot successfully raise additional capital, its liquidity, financial condition and business prospects will be materially and adversely affected. The Company is continually looking into further capital planning and the evaluation of strategic alternatives. There is substantial doubt about the Company’s ability to continue as a going concern. |
Basis of Presentation | Basis of Presentation The accompanying financial statements were prepared based on the accrual method of accounting in accordance with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the FASB. |
Use of estimates | Use of Estimates The preparation of the 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 contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates, including those related to the recoverability of long-lived assets, stock-based compensation, the valuation of financial instruments, and the valuation of deferred tax assets and liabilities. The Company’s estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Although actual results could differ from those estimates, management does not believe that such differences would be material. |
Concentrations of credit risk | Concentrations of credit risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and marketable debt securities. All cash is held in United States financial institutions that are federally insured. At times, the Company may maintain cash balances in excess of the federally insured amount. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. The Company’s investments in marketable debt securities have been issued by corporate entities and government-sponsored enterprises with high credit ratings. The Company mitigates investment risks by investing in highly-rated securities with relatively short maturities that the Company believes do not subject it to undue investment or credit risk. If any of these financial institutions fail to perform their obligations under the terms of these financial instruments, the Company’s maximum exposure to potential losses would be equal to the amounts reported on the balance sheet. |
Segment and geographic information | Segment and Geographic Information Operating segments are defined as components of an entity 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 as and manages its business in one operating segment operating exclusively in the United States. |
Cash and cash equivalents | 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. |
Marketable securities | Marketable securities Marketable securities consist of debt securities with maturities greater than three months from the date of purchase that include commercial paper and corporate notes. Classification of marketable securities between current and non-current is dependent upon the maturity date at the balance sheet date taking into consideration the Company’s ability and intent to hold the investment to maturity. There were no outstanding marketable securities as of December 31, 2023 and 2022. Interest and dividend income are recorded when earned and included in interest income in the statement of operations. Premiums and discounts, if any, on marketable securities are amortized or accreted to maturity and included in interest income in the statement of operations. The specific identification method is used in computing realized gains and losses on the sale of the Company’s marketable securities. The Company classifies its marketable securities as available-for-sale. The Company determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. Marketable securities that are classified as available-for-sale are measured at fair value on the balance sheet, and unrealized gains and losses on marketable securities are reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit) until realized. Marketable securities are evaluated periodically to determine whether the carrying value of a marketable security exceeds its fair value and the decline in value is determined to be other-than-temporary. Management reviews criteria, such as the general market conditions, magnitude and duration in which the fair value has been less than the carrying value, the investment issuer’s financial condition and business outlook, as well as the Company’s ability to hold the securities until the recovery of its amortized cost basis, to determine whether the decline in value is other-than-temporary. If a decline in value is determined to be other-than-temporary, the value of the marketable security is reduced, and the impairment is recorded as other expense in the statement of operations. As of December 31, 2022, any decline |
Fair value measurements | Fair value measurements The Company’s financial instruments include cash and cash equivalents, marketable securities, accounts payable, and accrued expenses. The fair values of the cash and cash equivalents, accounts payable and accrued expenses approximated their carrying values as of December 31, 2023 and 2022, due to their short-term maturities. For a description of the fair value of marketable securities, refer to Note 4. The Company accounts for recurring and nonrecurring fair value measurements in accordance with ASC 820, Fair Value Measurements (“ASC 820”). 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 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 judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC 820 hierarchy. |
Property and equipment | Property and equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Major replacements and improvements that extend the useful lives of assets are capitalized, while general repairs and maintenance are charged to expense as incurred. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the estimated useful lives of the assets or the related lease term, whichever is shorter. Upon retirement or disposal, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is recognized within operating expenses. The estimated useful lives of property, plant and equipment by major category are as follows: Estimated Useful Life Laboratory equipment 7 years Computer equipment and software 3 years Furniture and fixtures 7 years Leasehold Improvements Shorter of lease term or useful life |
Impairment of long-lived assets and Loss on assets held for sale | Impairment of long-lived assets The Company evaluates the carrying value of its long-lived asset group for potential impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. other expense Loss on assets held for sale Loss on assets held for sale is the difference between the asset’s estimated fair value less estimated costs to sell and the asset’s book value at the time the asset is no longer used for operations and reclassified as held for sale in accordance with the held-for-sale criteria. |
Research and development | Research and development Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including share-based compensation, as well as costs for third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, based on its estimates of services performed and costs incurred. These estimates include the level of services performed by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expenses in future periods as the related services are rendered. |
Clinical trial and contract development and manufacturing organization expenses | Clinical trial and contract development and manufacturing organization expenses The Company makes payments in connection with clinical trials and contract development and manufacturing organizations (“CDMO”) under contracts with contract research organizations that support conducting and managing clinical trials and the manufacturing of materials utilized in clinical and preclinical activities. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of the obligation to make payments under these contracts depends on factors such as the successful enrollment, treatment of patients, the completion of other clinical trial milestones, or completion of manufacturing milestones. Termination clauses within the agreements require notification for a certain number of days prior to completing work, payments for costs incurred through the termination date, and termination penalty, if applicable. Expenses related to clinical trials are accrued based on estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. Expenses related to development and manufacturing are accrued based on estimates and/or representations from service providers regarding work performed, including progress in the development of processes through technology transfers to manufacture the Company’s clinical material and completion of the manufactured clinical material. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts the Company is obligated to pay under clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the accruals are adjusted accordingly. Revisions to contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. |
Stock-based compensation | Stock-based compensation The Company records compensation expense associated with stock options and other forms of equity compensation based on the estimated fair value at the grant date. Compensation expense related to awards to employees and non-employees with service based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the requisite service period of the award, which is generally the vesting term. The Company’s policy is to account for forfeitures as they occur. The Company uses the Black-Scholes-Merton option pricing, or Black-Scholes, model to estimate the fair value of stock options. The Black-Scholes model requires input-based assumptions that are highly subjective, judgmental and sensitive in the determination of stock-based compensation cost. Options granted after the Company’s Initial Public Offering, or IPO, are issued at the fair market value of the Company’s common stock at the date the grant is approved by the Board of Directors. Expected volatility —The expected volatility was based on the historical volatility of comparable public companies from a representative peer group selected based on industry and market capitalization data. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. Risk-free interest rate —The risk-free interest rate was based on the continuous rates provided by the U.S. Treasury with a term approximating the expected term of the option. Expected dividend yield —The expected dividend yield was 0% because the Company has not historically paid and does not expect to pay any dividends for the foreseeable future. Expected term —The Company uses the simplified method as prescribed by the Securities and Exchange Commission, or the SEC, Staff Accounting Bulletin No. 107, Share-Based-Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax expense or benefit is the result of changes in deferred tax assets and liabilities. Valuation allowances are established when necessary to reduce deferred tax assets where, based upon the available evidence, the Company concludes it is more-likely-than-not that the deferred tax assets will not be realized. In evaluating its ability to recover deferred tax assets, the Company considers all available positive and negative evidence, including its operating results, on-going tax planning and forecasts of future taxable income on a jurisdiction-by-jurisdiction basis. The Company recorded a valuation allowance against all estimated net deferred tax assets as of December 31, 2023 and 2022. |
Net loss per share attributable to common stockholders | Net Loss Per Share Attributable to Common Stockholders |
Recent accounting standards and pronouncements | Recent accounting standards and pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) ("ASU 2016-13"), which modifies the measurement of expected credit losses on certain financial instruments. In addition, for available-for-sale debt securities, the standard eliminates the concept of other-than-temporary impairment and requires the recognition of an allowance for credit losses rather than reductions in the amortized cost of the securities. The standard is effective for fiscal year beginning after December 15, 2022 and interim periods beginning after December 15, 2022 and requires a modified-retrospective approach with a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period. Early adoption is permitted. Based on the composition of the Company’s investment portfolio, current market conditions and historical credit loss activity, the adoption of ASU 2016-13 did not have a material impact on the Company’s financial position, results of operations or the related disclosures. The Company adopted the new guidance on January 1, 2023 and determined there was no impact. Not Yet Adopted In October 2023, the FASB issued ASU 2023-06—Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, to clarify or improve disclosure and presentation requirements of a variety of Topics. ASU 2023-06 adds 14 of the 27 identified disclosure or presentation requirements to the Codification. However, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation requirement from its existing regulations by June 30, 2027. The effective dates of ASU 2023-06 will depend, in part, on whether an entity is already subject to the SEC’s current disclosure requirements. For such entities and those that must “file or furnish financial statements with or to the SEC in preparation for the sale of or for purposes of issuing securities that are not subject to contractual restrictions on transfer,” the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. For all other entities, the amendments will be effective two years after the date of such removal. The Company is currently assessing the effect of this ASU on its financial statements and related disclosures. In November 2023, the FASB issued ASU 2023-07—Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, to improve the disclosures about a public entity’s reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses. All public entities will be required to report segment information in accordance with the new guidance starting in annual periods beginning after December 15, 2023. The Company plans to adopt the ASU for the fiscal year beginning January 1, 2024. Since the Company has only one reportable segment, the Company will need to disclose the title and position of the chief operating decision maker (“CODM”) and an explanation of how the CODM uses the reported measures of segment profit or loss in assessing segment performance and deciding how to allocate resources, as well as disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the CODM. The Company is currently assessing the effect of this ASU on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information as well as certain other amendments to improve the effectiveness of income tax disclosures. The amendments in this update are effective for annual periods beginning after December 15, 2024. The Company does not expect adoption of this ASU to have a material impact on its results of operations, financial condition, and its financial statements other than adding new disclosures, which the Company is currently evaluating, as the Company has not recorded any net tax provision for the periods presented due to the losses incurred and the need for a full valuation allowance on net deferred tax assets. Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s financial statements and related disclosures upon adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Reconciliation of cash, cash equivalents, and restricted cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the statement of cash flows. December 31, 2023 2022 Cash and cash equivalents $ 3,202,452 $ 34,642,340 Restricted cash 20,000 55,000 Total $ 3,222,452 $ 34,697,340 |
Schedule of estimated useful lives of property, plant and equipment | The estimated useful lives of property, plant and equipment by major category are as follows: Estimated Useful Life Laboratory equipment 7 years Computer equipment and software 3 years Furniture and fixtures 7 years Leasehold Improvements Shorter of lease term or useful life Property and equipment consist of the following at December 31, 2023 and 2022: 2023 2022 Laboratory equipment $ 2,668,280 $ 6,803,996 Computer equipment and software 202,963 516,974 Furniture and fixtures — 47,877 Leasehold improvements 36,459 319,816 2,907,702 7,688,663 Less accumulated depreciation and amortization (1,554,801) (3,229,592) Property and equipment, net $ 1,352,901 $ 4,459,071 |
Summary of basic and diluted earnings per share | The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2023 and 2022: 2023 2022 Net loss $ (32,344,393) $ (62,506,199) Net loss attributable to common stockholders $ (32,344,393) $ (62,506,199) Basic and diluted net loss per common share $ (30.82) $ (64.95) Basic and diluted weighted average common shares outstanding 1,049,468 962,364 |
Summary of antidilutive securities outstanding | The following potentially dilutive securities have been excluded from the computation of diluted weighted average common shares outstanding at December 31, 2023 and 2022, as the effect would be anti-dilutive: 2023 2022 Stock options 130,526 158,620 Restricted stock units 26,460 62,320 Total 156,986 220,940 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value assets and liabilities measured on recurring basis | The following table represents the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis: December 31, 2023 December 31, 2022 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Assets Money market funds $ 23,270 $ — $ — $ 23,722,328 $ — $ — Fixed income debt securities $ — $ — $ — $ — $ 7,979,279 $ — $ 23,270 $ — $ — $ 23,722,328 $ 7,979,279 $ — |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Summary of prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following at December 31, 2023 and 2022: 2023 2022 Prepaid research and development expenses $ 115,353 $ 1,176,491 Prepaid maintenance agreements — 369,606 Prepaid insurance 368,048 403,653 Prepaid other 35,817 245,278 Interest receivable — 74,467 Other current assets 215,246 401,916 $ 734,464 $ 2,671,411 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Summary of property and equipment | The estimated useful lives of property, plant and equipment by major category are as follows: Estimated Useful Life Laboratory equipment 7 years Computer equipment and software 3 years Furniture and fixtures 7 years Leasehold Improvements Shorter of lease term or useful life Property and equipment consist of the following at December 31, 2023 and 2022: 2023 2022 Laboratory equipment $ 2,668,280 $ 6,803,996 Computer equipment and software 202,963 516,974 Furniture and fixtures — 47,877 Leasehold improvements 36,459 319,816 2,907,702 7,688,663 Less accumulated depreciation and amortization (1,554,801) (3,229,592) Property and equipment, net $ 1,352,901 $ 4,459,071 |
Restructuring Activities (Table
Restructuring Activities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Summary of Charges Related to Restructuring Activities | The following table summarizes the charges related to the restructuring activities as of December 31, 2023 and December 31, 2022. Accrued Restructuring Expenses Accrued Restructuring Expenses December 31, 2022 Expenses Less: Payments December 31, 2023 Severance, benefits and related costs due to workforce reduction $ 382,389 $ 3,090,371 $ (3,206,223) $ 266,537 Totals $ 382,389 $ 3,090,371 $ (3,206,223) $ 266,537 Accrued Restructuring Expenses Accrued Restructuring Expenses December 31, 2021 Expenses Less: Payments December 31, 2022 Severance, benefits and related costs due to workforce reduction $ — $ 531,829 $ (149,440) $ 382,389 Totals $ — $ 531,829 $ (149,440) $ 382,389 |
Accrued Expenses and other cu_2
Accrued Expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Summary of the components of accrued expenses | A summary of the components of accrued expenses is as follows as of December 31, 2023 and 2022: 2023 2022 Accrued research and development costs $ 3,148,021 $ 3,210,794 Accrued professional fees 131,226 267,383 Accrued salaries, benefits and related expenses 389,858 3,855,797 Other accrued expenses and other current liabilities 10,000 23,179 Total $ 3,679,105 $ 7,357,153 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Terms of Option Repricing | The Nasdaq Stock Market on the Effective Date, which was $0.41 per share, or the “Nasdaq Market Price”, on the terms described below: Repriced Options Terms of Repriced Options vested or vesting within six months following the Effective Date Terms of Repriced Options vesting more than six months following the Effective Date All options held by employees other than our executive officers, in good standing on the Effective Date The Option Repricing exercise price will be equal to 2.5 times the Nasdaq Market Price, or $25.75 The Option Repricing exercise price will be equal to the Nasdaq Market Price, or $10.25. All options held by our current executive officers and 100,000 options held by Jerome Zeldis, our former Executive Vice President and Head of Research & Development The Option Repricing exercise price will be equal to 3.0 times the Nasdaq Market Price, or $30.75. The Option Repricing exercise price will be equal to 2.0 times the Nasdaq Market Price, or $20.50. All options held by our directors The Option Repricing exercise price will be equal to 4.0 times the Nasdaq Market Price, or $41.00. The Option Repricing exercise price will be equal to 3.0 times the Nasdaq Market Price, $30.75. |
Summary of stock-based compensation expense | Stock-based compensation expense was recorded in the following financial statement line items within the statement of operations for the years ended December 31, 2023 and 2022: 2023 2022 Research and development expenses $ 1,133,428 $ 3,812,441 General and administrative expenses 2,420,198 2,057,923 Total stock-based compensation expense $ 3,553,626 $ 5,870,364 |
Summary of option activity | The following is a summary of option activity under the Company’s Stock Option Plans: Stock Weighted Weighted Aggregate Outstanding as of January 1, 2023 158,620 $ 184.51 8.0 $ — Granted 46,644 9.44 Exercised — — Cancelled (53,271) 172.1 Forfeited (21,467) 61.18 Outstanding as of December 31, 2023 130,526 $ 28.64 7.3 $ — Vested or expected to vest as of December 31, 2023 130,526 $ 28.64 7.3 $ — Exercisable as of December 31, 2023 78,536 $ 38.73 6.3 $ — Shares unvested as of December 31, 2023 52,030 $ 13.95 8.9 $ — |
Summary of black-scholes option pricing model | The options were valued using the Black-Scholes option-pricing model for the years ended December 31, 2023 and 2022 with the following assumptions: 2023 2022 Expected volatility 90.2% to 93.7% 78.6% to 83.2% Risk-free interest rate 3.4% to 4.20% 1.5% to 3.80% Expected dividend yield 0% 0% Expected term 5.5 to 6.1 years 5.5 to 6.1 years |
Summary of RSU activity | The following is a summary of RSU activity for the 2021 Plan for the year ended December 31, 2023: Number of restricted units Weighted average grant date fair value Unvested and outstanding at January 1, 2023 62,320 $ 11.30 Granted — — Settled (31,044) 11.25 Forfeited (4,816) 11.25 Unvested and outstanding as of December 31, 2023 26,460 $ 11.36 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of provision for income taxes | The Company’s provision for income taxes consists of the following for the years ended December 31, 2023 and 2022: 2023 2022 Current income tax provision: Federal $ — $ — State — — Total — — Deferred income tax benefit: Federal 4,967,519 12,339,546 State 15,852 (7,370,113) Total 4,983,371 4,969,433 Change in valuation allowance (4,983,371) (4,969,433) Total provision (benefit) for income taxes $ — $ — |
Schedule of effective income tax rate reconciliation | A reconciliation of the statutory U.S. income tax rate to the effective income tax rate as of December 31, 2023 and 2022 is as follows: 2023 2022 U.S. Federal statutory rate 21.00 % 21.00 % State taxes 0.20 % 0.17 % Permanent differences (0.89) % (0.58) % Other adjustments (4.81) % (0.02) % Change in state tax rate 0.01 % (12.61) % Change in valuation allowance (15.51) % (7.96) % Provision for income taxes 0.00 % 0.00 % |
Schedule of deferred tax assets and liabilities | The significant components of the Company’s deferred tax assets (liabilities) as of December 31, 2023 and 2022 were as follows: 2023 2022 Deferred tax assets: Net operating loss carryforward $ 32,486,609 $ 28,477,866 Accrued compensation 542,591 575,883 Stock compensation 825,801 1,913,771 Research and development credits 291,022 291,022 Capitalized research and development costs 9,826,015 7,838,512 Operating leases 14,587 216,925 Other 2,025 2,022 Gross deferred income tax assets 43,988,650 39,316,001 Less: Valuation allowance (43,840,838) (38,857,468) Total deferred income tax assets 147,812 458,533 Deferred tax liabilities: ROU assets (9,903) (204,694) Depreciation and amortization (137,909) (253,839) Total deferred tax liabilities (147,812) (458,533) Net deferred tax assets $ — $ — |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Components of Lease Cost | The components of lease cost under ASC 842 for the year ended December 31, 2023 are as follows: Lease costs Statement of Operations Classification December 31, 2023 December 31, 2022 Operating lease cost Operating expenses: research and development $ 331,215 $ 379,288 Operating lease cost Operating expenses: general and administrative 228,354 207,401 $ 559,569 $ 586,689 |
Schedule of Cash Flow, Supplemental Disclosures | Supplemental disclosure of cash flow information and weighted average remaining lease term and discount rate related to leases were as follows: Other information December 31, 2023 December 31, 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (617,999) $ (584,429) Right-of-use assets in exchange for operating lease liabilities $ (382,910) $ — Weighted-average remaining lease term — operating leases 0.1 years 1.8 years Weighted-average discount rate — operating leases 6.7 % 6.8 % |
Future Fixed Lease Payments | Future fixed lease payments for operating leases in effect as of December 31, 2023, are payable as follows: Maturity of lease liabilities for the years ending December 31, Operating Leases 2024 $ 68,898 2025 — 2026 — 2027 — 2028 — Thereafter — Total lease payment $ 68,898 Less: imputed interest (89) Present value of lease liabilities $ 68,809 |
Description of the Business (De
Description of the Business (Details) | Feb. 02, 2024 USD ($) $ / shares shares | Oct. 18, 2023 | Dec. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) $ / shares |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit | $ | $ (222,594,047) | $ (190,249,654) | ||
Long term debt | $ | 0 | |||
Cash and cash equivalents | $ | $ 3,202,452 | $ 34,642,340 | ||
Stock split, conversion ratio | 0.04 | |||
Subsidiary, Sale of Stock [Line Items] | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||
Subsequent Event | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||
Registered Offering | Subsequent Event | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued in transaction (in shares) | shares | 117,000 | |||
Issuance price (in dollars per share) | $ / shares | $ 12.05 | |||
Consideration received on transaction | $ | $ 3,700,000 | |||
Registered Offering | Subsequent Event | Pre-Funded Warrants | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of securities called by warrants (in shares) | shares | 187,731 | |||
Offering price of warrants (in dollars per share) | $ / shares | $ 12.049 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Number of operating segments | segment | 1 | |
Investment positions in marketable securities | $ 0 | $ 0 |
Impairment of long-lived assets | $ 100,000 | $ 0 |
Impairment, Long-Lived Asset, Held-for-Use, Statement of Income or Comprehensive Income [Extensible Enumeration] | Other expense | |
Expected dividend yield | 0% | 0% |
Unrecognized tax benefits | $ 0 | $ 0 |
Accruals related to uncertain tax positions | 0 | 0 |
Income tax penalties and interest expense | 0 | 0 |
Operating lease right-of-use assets, net | 46,716 | 967,032 |
Operating lease, liability, current | (68,809) | (599,047) |
Operating Lease, Liability, non-current | $ 0 | $ (425,766) |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Restricted Cash and Cash Equivalents (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 3,202,452 | $ 34,642,340 | |
Restricted cash | 20,000 | 55,000 | |
Total | $ 3,222,452 | $ 34,697,340 | $ 30,393,852 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Useful Lives of Property Plant and Equipment (Details) | Dec. 31, 2023 |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life | 7 years |
Computer equipment and software | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Useful life | 7 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Basic and Diluted Earnings Per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Net loss | $ (32,344,393) | $ (62,506,199) |
Net loss attributable to common stockholders | (32,344,393) | (62,506,199) |
Net loss attributable to common stockholders | $ (32,344,393) | $ (62,506,199) |
Basic net loss attributable to common stockholders per common share (in dollars per share) | $ (30.82) | $ (64.95) |
Diluted net loss attributable to common stockholders per common share (in dollars per share) | $ (30.82) | $ (64.95) |
Basic weighted average number of common shares outstanding (in shares) | 1,049,468 | 962,364 |
Diluted weighted-average number of common shares outstanding (in shares) | 1,049,468 | 962,364 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities Outstanding (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities (in shares) | 156,986 | 220,940 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities (in shares) | 130,526 | 158,620 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities (in shares) | 26,460 | 62,320 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value Assets and Liabilities Measured on Recurring Basis (Detail) - Recurring basis - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Level 1 | ||
Assets | ||
Total assets | $ 23,270 | $ 23,722,328 |
Level 1 | Money market funds | ||
Assets | ||
Money market funds | 23,270 | 23,722,328 |
Level 1 | Fixed income debt securities | ||
Assets | ||
Fixed income debt securities | 0 | 0 |
Level 2 | ||
Assets | ||
Total assets | 0 | 7,979,279 |
Level 2 | Money market funds | ||
Assets | ||
Money market funds | 0 | 0 |
Level 2 | Fixed income debt securities | ||
Assets | ||
Fixed income debt securities | 0 | 7,979,279 |
Level 3 | ||
Assets | ||
Total assets | 0 | 0 |
Level 3 | Money market funds | ||
Assets | ||
Money market funds | 0 | 0 |
Level 3 | Fixed income debt securities | ||
Assets | ||
Fixed income debt securities | $ 0 | $ 0 |
Prepaid Expenses And Other Cu_3
Prepaid Expenses And Other Current Assets - Summary of Prepaid Expenses And Other Current Assets (Detail) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid research and development expenses | $ 115,353 | $ 1,176,491 |
Prepaid maintenance agreements | 0 | 369,606 |
Prepaid insurance | 368,048 | 403,653 |
Prepaid other | 35,817 | 245,278 |
Interest receivable | 0 | 74,467 |
Other current assets | 215,246 | 401,916 |
Prepaid expenses and other current assets | $ 734,464 | $ 2,671,411 |
Property and Equipment - Summar
Property and Equipment - Summary of Property And Equipment (Detail) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment gross | $ 2,907,702 | $ 7,688,663 |
Less accumulated depreciation and amortization | (1,554,801) | (3,229,592) |
Property and equipment, net | 1,352,901 | 4,459,071 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment gross | 2,668,280 | 6,803,996 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment gross | 202,963 | 516,974 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment gross | 0 | 47,877 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment gross | $ 36,459 | $ 319,816 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Property, Plant and Equipment [Abstract] | |
Depreciation and amortization | $ 1,000,000 |
Assets Held For Sale (Details)
Assets Held For Sale (Details) - USD ($) | 12 Months Ended | ||
Nov. 29, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||
Costs to sell | $ 1,400,000 | ||
Carrying value of assets | 2,000,000 | ||
Loss on assets held for sale | $ (700,000) | $ 690,768 | $ 0 |
Restructuring Activities (Detai
Restructuring Activities (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Nov. 30, 2022 USD ($) employee | Oct. 31, 2023 USD ($) employee | Dec. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2021 USD ($) | |
Restructuring and Related Activities [Abstract] | |||||
Restructuring reserve | $ 382,389 | $ 266,537 | $ 0 | ||
Restructuring Cost and Reserve [Line Items] | |||||
Reduction in headcount, percentage | 30% | ||||
Number of positions before eliminations | employee | 74 | 44 | |||
Number of positions after eliminations | employee | 50 | 6 | |||
Restructuring, expected cost | $ 700,000 | ||||
Restructuring reserve | 382,389 | 266,537 | 0 | ||
Restructuring, incurred cost | $ 3,100,000 | $ 500,000 | |||
Restructuring Incurred Cost Statement Of Income Or Comprehensive Income Extensible Enumeration Not Disclosed Flag | costs associated with the restructuring | ||||
Employee Severance | |||||
Restructuring and Related Activities [Abstract] | |||||
Restructuring reserve | $ 382,389 | 266,537 | 0 | ||
Restructuring Cost and Reserve [Line Items] | |||||
Restructuring reserve | $ 382,389 | $ 266,537 | $ 0 |
Restructuring Activities - Summ
Restructuring Activities - Summary of Charges Related to Restructuring Activities (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restructuring Reserve [Roll Forward] | ||
Accrued Restructuring Expenses, beginning balance | $ 382,389 | $ 0 |
Expenses | 3,090,371 | 531,829 |
Less: Payments | (3,206,223) | (149,440) |
Accrued Restructuring Expenses, ending balance | 266,537 | 382,389 |
Employee Severance | ||
Restructuring Reserve [Roll Forward] | ||
Accrued Restructuring Expenses, beginning balance | 382,389 | 0 |
Expenses | 3,090,371 | 531,829 |
Less: Payments | (3,206,223) | (149,440) |
Accrued Restructuring Expenses, ending balance | $ 266,537 | $ 382,389 |
Accrued Expenses and other cu_3
Accrued Expenses and other current liabilities - Summary of Components of Accrued Expenses (Detail) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued research and development costs | $ 3,148,021 | $ 3,210,794 |
Accrued professional fees | 131,226 | 267,383 |
Accrued salaries, benefits and related expenses | 389,858 | 3,855,797 |
Other accrued expenses and other current liabilities | 10,000 | 23,179 |
Accrued expenses and other current liabilities | $ 3,679,105 | $ 7,357,153 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information, Maryland Biotechnology Center Grant (Details) - USD ($) | 12 Months Ended | ||
May 23, 2013 | Dec. 31, 2023 | May 23, 2012 | |
Supply Commitment [Line Items] | |||
Research and development arrangement contract to perform for others compensation earned | $ 125,000 | ||
Maryland Biotechnology Center | Translational Research Award Agreement | |||
Supply Commitment [Line Items] | |||
Research and development arrangement contract to perform for others liability | $ 325,000 | $ 0 | $ 200,000 |
Research and development arrangement annual payment percentage | 3% | ||
Research and development arrangement contractual payment period | 10 years | ||
Research and development arrangement, contractual payment percentage | 200% | ||
Revenue from contract with customer, including assessed tax | $ 0 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information, Johns Hopkins University Exclusive License Agreement (Details) - USD ($) | 12 Months Ended | ||
Jan. 01, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | |
Supply Commitment [Line Items] | |||
Accrued royalties | $ 50,000 | $ 50,000 | |
Minimum | Research and development expenses | |||
Supply Commitment [Line Items] | |||
Royalty expense | 100,000 | $ 100,000 | |
Johns Hopkins University | Exclusive License Agreement | |||
Supply Commitment [Line Items] | |||
Milestone fees | $ 4,200,000 | ||
Minimum annual royalty payments | $ 100,000 | ||
Sublicense consideration payment, maximum percent | 15% | ||
Cumulative minimum royalties | $ 625,000 | ||
Johns Hopkins University | Exclusive License Agreement | Clinical Trial Milestones | |||
Supply Commitment [Line Items] | |||
Milestone fees | 75,000 | ||
Johns Hopkins University | Exclusive License Agreement | Therapeutic Field | |||
Supply Commitment [Line Items] | |||
Milestone fees | 1,600,000 | ||
Johns Hopkins University | Exclusive License Agreement | Regulatory and Commercial Milestones | |||
Supply Commitment [Line Items] | |||
Milestone fees | 400,000 | ||
Johns Hopkins University | Exclusive License Agreement | Non-clinical field | |||
Supply Commitment [Line Items] | |||
Milestone fees | $ 100,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||
Feb. 02, 2024 | Jun. 17, 2022 | Mar. 09, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Class of Stock [Line Items] | |||||
Authorized common stock (in shares) | 250,000,000 | 250,000,000 | |||
Common stock, shares outstanding (in shares) | 1,066,320 | 1,043,138 | |||
Common stock, shares issued (in shares) | 1,066,320 | 1,043,138 | |||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||
Issuance of common stock, net of transaction costs | $ 5,145,409 | ||||
Subsequent Event | |||||
Class of Stock [Line Items] | |||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||
At-The-Market Offering | |||||
Class of Stock [Line Items] | |||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||
Aggregate offering price | $ 50,000,000 | $ 200,000,000 | |||
Commission percentage | 3% | ||||
Number of shares issued in transaction (in shares) | 127,396 | ||||
Consideration received on transaction | $ 0 | $ 5,100,000 | |||
Registered Offering | Subsequent Event | |||||
Class of Stock [Line Items] | |||||
Number of shares issued in transaction (in shares) | 117,000 | ||||
Consideration received on transaction | $ 3,700,000 | ||||
Issuance price (in dollars per share) | $ 12.05 | ||||
Registered Offering | Subsequent Event | Pre-Funded Warrants | |||||
Class of Stock [Line Items] | |||||
Number of securities called by warrants (in shares) | 187,731 | ||||
Offering price of warrants (in dollars per share) | $ 12.049 | ||||
Private Placement | Subsequent Event | Unregistered Warrants | |||||
Class of Stock [Line Items] | |||||
Number of securities called by warrants (in shares) | 304,731 | ||||
Exercise price of warrants (in dollars per share) | $ 12.05 | ||||
Warrants expiration term | 2 years |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||
Feb. 28, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 22, 2023 | Mar. 01, 2023 | Sep. 30, 2018 | Jul. 31, 2018 | Mar. 01, 2017 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Shares reserved (in shares) | 110,302 | 69,670 | ||||||
Shares available for issuance (in shares) | 152,533 | |||||||
Award expiration period | 10 years | |||||||
Weighted average fair value of the options granted (in dollars per share) | $ 7.17 | $ 60.50 | ||||||
Share price (in dollars per share) | $ 0.41 | |||||||
Accelerated vesting expense | $ 0.6 | |||||||
Fair value of stock options vested | 2.2 | $ 9.2 | ||||||
Intrinsic value of stock options exercised | 0 | $ 0.2 | ||||||
Unrecognized compensation expense | 1.9 | |||||||
Stock options | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Incremental expense | $ 0.2 | |||||||
Unrecognized compensation expense period for recognition | 1 year 10 months 24 days | |||||||
Restricted stock units | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Award vesting period | 18 months | |||||||
Unrecognized compensation expense period for recognition | 4 months 24 days | |||||||
Minimum | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Award vesting period | 1 year | |||||||
Maximum | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Award vesting period | 4 years | |||||||
Maximum | Stock options | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Incremental expense | $ 0.3 | |||||||
The 2017 Plan | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Shares reserved (in shares) | 26,433 | |||||||
The 2018 Plan | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Shares reserved (in shares) | 72,365 | |||||||
The 2021 Plan | ||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||||
Percentage of outstanding stock maximum | 5% |
Stock-Based Compensation - Term
Stock-Based Compensation - Terms of Option Repricing (Details) | Dec. 31, 2023 shares | Apr. 04, 2023 shares | Mar. 22, 2023 $ / shares | Dec. 31, 2022 shares |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Shares outstanding (in shares) | shares | 130,526 | 158,620 | ||
Employees, Excluding Executive Officer | Terms of Repriced Options vested or vesting within six months following the Effective Date | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Repricing multiple | 2.5 | |||
Repricing exercise price (in dollars per share) | $ 25.75 | |||
Employees, Excluding Executive Officer | Terms of Repriced Options vesting more than six months following the Effective Date | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Repricing exercise price (in dollars per share) | $ 10.25 | |||
Executive Officer | Jerome Zeldis | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Shares outstanding (in shares) | shares | 100,000 | |||
Executive Officer | Terms of Repriced Options vested or vesting within six months following the Effective Date | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Repricing multiple | 3 | |||
Repricing exercise price (in dollars per share) | $ 30.75 | |||
Executive Officer | Terms of Repriced Options vesting more than six months following the Effective Date | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Repricing multiple | 2 | |||
Repricing exercise price (in dollars per share) | $ 20.50 | |||
Director | Terms of Repriced Options vested or vesting within six months following the Effective Date | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Repricing multiple | 4 | |||
Repricing exercise price (in dollars per share) | $ 41 | |||
Director | Terms of Repriced Options vesting more than six months following the Effective Date | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Repricing multiple | 3 | |||
Repricing exercise price (in dollars per share) | $ 30.75 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 3,553,626 | $ 5,870,364 |
Research and development expenses | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 1,133,428 | 3,812,441 |
General and administrative expenses | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 2,420,198 | $ 2,057,923 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Option Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of restricted units | ||
Outstanding as of beginning of period (in shares) | 158,620 | |
Granted (in shares) | 46,644 | |
Exercised (in shares) | 0 | |
Cancelled (in shares) | (53,271) | |
Forfeited (in shares) | (21,467) | |
Outstanding as of end of period (in shares) | 130,526 | 158,620 |
Vested or expected to vest by period end (in shares) | 130,526 | |
Exercisable as of period end (in shares) | 78,536 | |
Shares unvested as of period end (in shares) | 52,030 | |
Weighted Average Exercise Price | ||
Outstanding as of beginning of period (in dollars per share) | $ 184.51 | |
Granted (in dollars per share) | 9.44 | |
Exercised (in dollars per share) | 0 | |
Cancelled (in dollars per share) | 172.1 | |
Forfeited (in dollars per share) | 61.18 | |
Outstanding as of end of period (in dollars per share) | 28.64 | $ 184.51 |
Vested or expected to vest as of end of period (in dollars per share) | 28.64 | |
Exercisable as of end of period (in dollars per share) | 38.73 | |
Shares unvested as of end of period (in dollars per share) | $ 13.95 | |
Weighted Average Remaining Contractual Term (years) | ||
Outstanding as of end of period (in years) | 7 years 3 months 18 days | 8 years |
Vested or expected to vest as of end of period (in years) | 7 years 3 months 18 days | |
Exercisable as of end of period (in years) | 6 years 3 months 18 days | |
Shares unvested as of end of period (in years) | 8 years 10 months 24 days | |
Aggregate Intrinsic Value (millions) | ||
Outstanding as of December 31, 2023 | $ 0 | $ 0 |
Vested or expected to vest as of December 31, 2023 | 0 | |
Exercisable as of December 31, 2023 | 0 | |
Shares unvested as of December 31, 2023 | $ 0 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Black-Scholes Option Pricing Model (Detail) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Expected volatility | 90.20% | 78.60% |
Expected volatility | 93.70% | 83.20% |
Risk-free interest rate | 3.40% | 1.50% |
Risk-free interest rate | 4.20% | 3.80% |
Expected dividend yield | 0% | 0% |
Minimum | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Expected term | 5 years 6 months | 5 years 6 months |
Maximum | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Expected term | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of RSU Activity (Details) - Restricted stock units $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Number of restricted units | |
Beginning balance (in shares) | shares | 62,320 |
Granted (in shares) | shares | 0 |
Vested (in shares) | shares | (31,044) |
Forfeited (in shares) | shares | (4,816) |
Ending balance (in shares) | shares | 26,460 |
Weighted Average Exercise Price | |
Beginning balance (dollars per share) | $ / shares | $ 11.30 |
Granted (dollars per share) | $ / shares | 0 |
Vested (dollars per share) | $ / shares | 11.25 |
Forfeited (dollars per share) | $ / shares | 11.25 |
Ending balance (dollars per share) | $ / shares | $ 11.36 |
Unrecognized compensation expense | $ | $ 0.1 |
Unrecognized compensation expense period for recognition | 4 months 24 days |
Income Taxes - Schedule of Prov
Income Taxes - Schedule of Provision For Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current income tax provision: | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Total | 0 | 0 |
Deferred income tax benefit: | ||
Federal | 4,967,519 | 12,339,546 |
State | 15,852 | (7,370,113) |
Total | 4,983,371 | 4,969,433 |
Change in valuation allowance | (4,983,371) | (4,969,433) |
Total provision (benefit) for income taxes | $ 0 | $ 0 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
U.S. Federal statutory rate | 21% | 21% |
State taxes | 0.20% | 0.17% |
Permanent differences | (0.89%) | (0.58%) |
Other adjustments | (4.81%) | (0.02%) |
Change in state tax rate | 0.01% | (12.61%) |
Change in valuation allowance | (15.51%) | (7.96%) |
Provision for income taxes | 0% | 0% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforward | $ 32,486,609 | $ 28,477,866 |
Accrued compensation | 542,591 | 575,883 |
Stock compensation | 825,801 | 1,913,771 |
Research and development credits | 291,022 | 291,022 |
Capitalized research and development costs | 9,826,015 | 7,838,512 |
Operating leases | 14,587 | 216,925 |
Other | 2,025 | 2,022 |
Gross deferred income tax assets | 43,988,650 | 39,316,001 |
Less: Valuation allowance | (43,840,838) | (38,857,468) |
Total deferred income tax assets | 147,812 | 458,533 |
Deferred tax liabilities: | ||
ROU assets | (9,903) | (204,694) |
Depreciation and amortization | (137,909) | (253,839) |
Total deferred tax liabilities | (147,812) | (458,533) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Tax Credit Carryforward [Line Items] | ||
Unrecognized tax benefits | $ 0 | $ 0 |
Accruals related to uncertain tax positions | $ 0 | 0 |
Valuation allowance | 1 | |
Federal | ||
Tax Credit Carryforward [Line Items] | ||
Operating loss carryforwards | $ 154,300,000 | $ 135,200,000 |
Operating loss carryforwards, subject to expiration | 10,500,000 | |
Operating loss carryforwards, not subject to expiration | $ 143,800,000 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) | 12 Months Ended | ||
Nov. 01, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |||
Leased assets exchanged for operating lease liabilities | $ 400,000 | $ 382,910 | $ 0 |
Leases - Components of Lease Co
Leases - Components of Lease Cost (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | $ 559,569 | $ 586,689 |
Research and development expenses | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | 331,215 | 379,288 |
General and administrative expenses | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | $ 228,354 | $ 207,401 |
Leases - Schedule of Cash Flow,
Leases - Schedule of Cash Flow, Supplemental Disclosures (Details) - USD ($) | 12 Months Ended | ||
Nov. 01, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |||
Operating cash flows from operating leases | $ (617,999) | $ (584,429) | |
Leased assets exchanged for operating lease liabilities | $ (400,000) | $ (382,910) | $ 0 |
Weighted-average remaining lease term — operating leases | 1 month 6 days | 1 year 9 months 18 days | |
Weighted-average discount rate — operating leases | 6.70% | 6.80% |
Leases - Future Fixed Lease Pay
Leases - Future Fixed Lease Payments (Details) | Dec. 31, 2023 USD ($) |
Retirement Benefits [Abstract] | |
2024 | $ 68,898 |
2025 | 0 |
2026 | 0 |
2027 | 0 |
2028 | 0 |
Thereafter | 0 |
Total lease payment | 68,898 |
Less: imputed interest | (89) |
Present value of lease liabilities | $ 68,809 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | 14 Months Ended | ||
Mar. 16, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Jul. 31, 2023 | |
Related Party Transaction [Line Items] | ||||
Joint research agreement term | 2 years | |||
Total value of statements of work | $ 200,000 | |||
Other expense | $ (69,166) | $ (87,682) | ||
Accrued expenses and other current liabilities | 3,679,105 | 7,357,153 | ||
Related Party | ||||
Related Party Transaction [Line Items] | ||||
Other expense | 100,000 | $ 40,000 | ||
Accrued expenses and other current liabilities | $ 25,000 |