COVER PAGE
COVER PAGE - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 03, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 000-21088 | ||
Entity Registrant Name | BRICKELL BIOTECH, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 93-0948554 | ||
Entity Address, Address Line One | 5777 Central Avenue, Suite 102, | ||
Entity Address, City or Town | Boulder, | ||
Entity Address, State or Province | CO | ||
Entity Address, Postal Zip Code | 80301 | ||
City Area Code | 720 | ||
Local Phone Number | 505-4755 | ||
Title of 12(b) Security | Common stock, $0.01 par value per share | ||
Trading Symbol | BBI | ||
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 | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 66.3 | ||
Entity Common Stock, Shares Outstanding | 119,377,286 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement relating to its 2022 annual meeting of shareholders (the “2022 Proxy Statement”) are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The 2022 Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. | ||
Entity Central Index Key | 0000819050 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Denver, Colorado |
Auditor Firm ID | 42 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 26,884 | $ 30,115 |
Prepaid expenses and other current assets | 2,716 | 3,415 |
Total current assets | 29,600 | 33,530 |
Property and equipment, net | 58 | 30 |
Operating lease right-of-use asset | 59 | 74 |
Total assets | 29,717 | 33,634 |
Current liabilities: | ||
Accounts payable | 1,605 | 568 |
Accrued liabilities | 3,136 | 5,420 |
Lease liability, current portion | 69 | 74 |
Note payable, current portion | 0 | 291 |
Total current liabilities | 4,810 | 6,353 |
Note payable, net of current portion | 0 | 146 |
Total liabilities | 4,810 | 6,499 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Common stock, $0.01 par value, 300,000,000 and 100,000,000 shares authorized as of December 31, 2021 and 2020, respectively; 119,377,286 and 53,551,461 shares issued and outstanding as of December 31, 2021 and 2020, respectively | 1,194 | 536 |
Additional paid-in capital | 169,080 | 132,492 |
Accumulated deficit | (145,367) | (105,893) |
Total stockholders’ equity | 24,907 | 27,135 |
Total liabilities and stockholders’ equity | $ 29,717 | $ 33,634 |
CONSOLIDATED BALANCE SHEETS (PA
CONSOLIDATED BALANCE SHEETS (PARENTHETICAL) - $ / shares | Dec. 31, 2021 | Apr. 19, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | |||
Common stock, par value (in usd per share) | $ 0.01 | $ 0.01 | |
Common stock, shares authorized | 300,000,000 | 300,000,000 | 100,000,000 |
Common stock, shares issued | 119,377,286 | 53,551,461 | |
Common stock, shares outstanding | 119,377,286 | 53,551,461 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenue | $ 404 | $ 1,822 |
Operating expenses: | ||
Research and development | 28,231 | 11,216 |
General and administrative | 12,417 | 11,582 |
Total operating expenses | 40,648 | 22,798 |
Loss from operations | (40,244) | (20,976) |
Investment and other income, net | 839 | 63 |
Interest expense | (69) | 0 |
Net loss | $ (39,474) | $ (20,913) |
Net loss per share basic (in usd per share) | $ (0.49) | $ (0.85) |
Net loss per share diluted (in usd per share) | $ (0.49) | $ (0.85) |
Weighted-average shares used to compute net loss per share, basic | 80,315,595 | 24,514,157 |
Weighted-average shares used to compute net loss per share, diluted | 80,315,595 | 24,514,157 |
Collaboration revenue | ||
Total revenue | $ 0 | $ 1,795 |
Royalty revenue | ||
Total revenue | $ 404 | $ 27 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (39,474) | $ (20,913) |
Other comprehensive income: | ||
Unrealized gain on available-for-sale marketable securities arising during holding period, net of tax benefit of $0 | 0 | 28 |
Total comprehensive loss | $ (39,474) | $ (20,885) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (PARENTHETICAL) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Unrealized loss arising during holding period, tax benefit | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In-Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2019 | 8,480,968 | ||||
Beginning Balance at Dec. 31, 2019 | $ 7,574 | $ 85 | $ 92,497 | $ (28) | $ (84,980) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock and common stock purchase warrants, net of issuance costs (in shares) | 39,103,810 | ||||
Issuance of common stock and common stock purchase warrants, net of issuance costs | 37,977 | $ 391 | 37,586 | ||
Issuance of common stock upon exercise of warrants (in shares) | 5,367,392 | ||||
Issuance of common stock upon exercise of warrants | 26 | $ 54 | (28) | ||
Issuance of common stock under license agreement (in shares) | 480,769 | ||||
Issuance of common stock under license agreement | 500 | $ 5 | 495 | ||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | 118,522 | ||||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | (50) | $ 1 | (51) | ||
Stock-based compensation | 1,993 | 1,993 | |||
Unrealized gain on available-for-sale marketable securities | 28 | 28 | |||
Net loss | $ (20,913) | (20,913) | |||
Ending Balance (in shares) at Dec. 31, 2020 | 53,551,461 | 53,551,461 | |||
Ending Balance at Dec. 31, 2020 | $ 27,135 | $ 536 | 132,492 | 0 | (105,893) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of warrants (in shares) | 12,444,887 | ||||
Issuance of common stock upon exercise of warrants | 8,969 | $ 124 | 8,845 | ||
Issuance of common stock under license agreement (in shares) | 2,816,901 | ||||
Issuance of common stock under license agreement | 1,971 | $ 28 | 1,943 | ||
Common stock issued, net of issuance costs of $1,773 (in shares) | 50,086,147 | ||||
Stock Issued During Period, Value, New Issues | 24,006 | $ 501 | 23,505 | ||
Issuance of common stock to settle accrued liabilities (in shares) | 200,000 | ||||
Issuance of common stock to settle accrued liabilities | 63 | $ 2 | 61 | ||
Common stock issued for cash under employee stock purchase plan (in shares) | 149,285 | ||||
Issuance of common stock for cash under employee stock purchase plan | 29 | $ 1 | 28 | ||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | 128,605 | ||||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | (55) | $ 2 | (57) | ||
Unrealized gain on available-for-sale marketable securities | 2,263 | 2,263 | |||
Net loss | $ (39,474) | (39,474) | |||
Ending Balance (in shares) at Dec. 31, 2021 | 119,377,286 | 119,377,286 | |||
Ending Balance at Dec. 31, 2021 | $ 24,907 | $ 1,194 | $ 169,080 | $ 0 | $ (145,367) |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (PARENTHETICAL) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance costs | $ 2,246 | $ 2,840 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (39,474) | $ (20,913) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,263 | 1,993 |
Issuance of common stock under license agreement | 1,971 | 500 |
Gain on loan extinguishment | (437) | 0 |
Issuance of common stock to settle accrued liabilities | 63 | 0 |
Depreciation | 22 | 10 |
Reduction of discount on marketable securities | 0 | 25 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 709 | 2,833 |
Accounts payable | 1,023 | (1,677) |
Accrued liabilities | (2,288) | (1,010) |
Deferred revenue | 0 | (1,795) |
Net cash used in operating activities | (36,148) | (20,034) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Capital expenditures, net | (36) | (23) |
Maturities of marketable securities | 0 | 4,500 |
Net cash provided by (used in) investing activities | (36) | 4,477 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of common stock and warrants, net of issuance costs | 24,006 | 37,977 |
Proceeds from the exercise of warrants | 8,969 | 26 |
Payments of taxes related to net share settlement of equity awards | (51) | 0 |
Proceeds from the issuance of commons stock under employee stock purchase program | 29 | 0 |
Proceeds from the issuance of note payable | 0 | 437 |
Net cash provided by financing activities | 32,953 | 38,440 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (3,231) | 22,883 |
CASH AND CASH EQUIVALENTS—BEGINNING | 30,115 | 7,232 |
CASH AND CASH EQUIVALENTS—ENDING | 26,884 | 30,115 |
Supplemental Disclosure of Non-Cash Investing and Financing Activities: | ||
Forgiveness of Paycheck Protection Program loan | $ 437 | $ 0 |
ORGANIZATION AND NATURE OF OPER
ORGANIZATION AND NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND NATURE OF OPERATIONS | ORGANIZATION AND NATURE OF OPERATIONS Brickell Biotech, Inc. (the “Company” or “Brickell”) is a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases. The Company’s pipeline combines several development-stage candidates and a cutting-edge platform with broad potential in autoimmune and inflammatory disorders with a potential best-in-class, late-stage program for the treatment of primary axillary hyperhidrosis. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis ® , Taltz ® , Gemzar ® , Prozac ® , Cymbalta ® , and Juvederm ® . The Company’s strategy includes leveraging this experience to in-license, acquire, develop, and commercialize innovative pharmaceutical products that it believes can meaningfully benefit patients who are suffering from chronic, debilitating diseases in the foregoing target disease areas and that are underserved by available therapies. The Company’s operations to date have been limited to business planning, raising capital, developing its pipeline assets (in particular sofpironium bromide), identifying and in-licensing product candidates, conducting clinical trials, and other research and development. Liquidity and Capital Resources The Company has incurred significant operating losses and has an accumulated deficit as a result of ongoing efforts to in-license and develop product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. For the year ended December 31, 2021, the Company had a net loss of $39.5 million and net cash used in operating activities of $36.1 million. As of December 31, 2021, the Company had cash and cash equivalents of $26.9 million and an accumulated deficit of $145.4 million. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Brickell Subsidiary, Inc., and are presented in United States (“U.S.”) dollars and prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which include all adjustments necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods presented. All significant intercompany balances have been eliminated in consolidation. The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. The Company’s management performed an evaluation of its activities through the date of filing of these financial statements and concluded that there are no subsequent events requiring disclosure, other than as disclosed. Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. GAAP, which requires it to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions. Risks and Uncertainties The Company’s business is subject to significant risks common to early-stage companies in the pharmaceutical industry including, but not limited to, the ability to develop appropriate formulations, scale up and produce the compounds; dependence on collaborative parties; uncertainties associated with obtaining and enforcing patents and other intellectual property rights; clinical implementation and success; the lengthy and expensive regulatory approval process; compliance with regulatory and other legal requirements; competition from other products; uncertainty of broad adoption of its approved products, if any, by physicians and patients; significant competition; ability to manage third-party manufacturers, suppliers, contract research organizations, business partners and other alliances; and obtaining additional financing to fund the Company’s efforts. The product candidates developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies prior to commercial sales in the U.S. or foreign jurisdictions, respectively. There can be no assurance that the Company’s current and future product candidates will receive the necessary approvals. If the Company is denied approval or approval is delayed, it may have a material adverse impact on the Company’s business and its financial condition. The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to develop and, if successful, commercialize its product candidates. There can be no assurance that such financing will be available or will be at terms acceptable to the Company. Cash and Cash Equivalents The Company considers all highly liquid debt instruments with an original maturity of three months or less from date of purchase to be cash equivalents. Cash equivalents, which are stated at cost, consist primarily of amounts held in short-term money market accounts with highly rated financial institutions. Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash and cash equivalents balances in several accounts with one financial institution which, from time to time, are in excess of federally insured limits. Property and Equipment Property and equipment is stated at cost, less accumulated depreciation. Expenditures for major betterments and additions are charged to the asset accounts, while replacements, maintenance, and repairs, which do not improve or extend the lives of the respective assets, are charged to expense as incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years. Depreciation expense amounted to $22 thousand and $10 thousand for the years ended December 31, 2021 and 2020, respectively. Fair Value Measurements Fair value is the price that the Company would receive to sell an asset or pay to transfer a liability in a timely transaction with an independent counterparty in the principal market, or in the absence of a principal market, the most advantageous market for the asset or liability. A three-tier hierarchy distinguishes between (1) inputs that reflect the assumptions market participants would use in pricing an asset or liability developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (2) inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing an asset or liability developed based on the best information available in the circumstances (unobservable inputs). The hierarchy is summarized in the three broad levels listed below: Level 1 —quoted prices in active markets for identical assets and liabilities Level 2 —other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.) Level 3 —significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities) The following table sets forth the fair value of the Company’s financial assets measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): Level 1 (1) December 31, 2021 2020 Assets: Money market funds $ 25,875 $ 29,182 ____________ (1) No assets as of each respective date were identified as Level 2 or 3 based on the three-tier fair value hierarchy. The Company had no financial liabilities measured at fair value on a recurring basis as of each respective date. Fair Value of Financial Instruments The following methods and assumptions were used by the Company in estimating the fair values of each class of financial instrument disclosed herein: Money Market Funds— The carrying amounts reported as cash and cash equivalents in the consolidated balance sheets approximate their fair values due to their short-term nature and/or market rates of interest (Level 1 of the fair value hierarchy). Leases The Company determines if an arrangement is a lease at inception. Operating leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company does not currently hold any financing leases. The Company has elected the practical expedient not to recognize on the balance sheet leases with terms of one year or less and not to separate lease components and non-lease components for long-term real estate leases. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company estimates the incremental borrowing rate based on industry peers in determining the present value of lease payments. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics. The Company’s facility operating lease has one single component. The lease component results in a right-of-use asset being recorded on the balance sheet, which is amortized as lease expense on a straight-line basis in the Company’s consolidated statements of operations. Revenue Recognition The Company currently recognizes revenue primarily from licensing and royalty fees received under the Kaken Agreement described in Note 3. “Strategic Agreements,” of which the terms of the agreement include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones, and royalties on net product sales. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company utilizes judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Collaboration Revenue The Company evaluates collaboration arrangements to determine whether units of account within the collaboration arrangement exhibit the characteristics of a vendor and customer relationship. Licenses of Intellectual Property If a license for the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, and other revenues and earnings in the period of adjustment and future periods through the end of the performance obligation period. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Research and Development Research and development costs are charged to expense when incurred and consist of costs incurred for independent and collaboration research and development activities. The major components of research and development costs include formulation development, nonclinical studies, clinical studies, clinical manufacturing costs, in-licensing fees for development-stage assets, salaries and employee benefits, and allocations of various overhead and occupancy costs. Research costs typically consist of applied research, preclinical, and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis, and the transfer and scale-up of manufacturing at contract manufacturers. Assets acquired (or in-licensed) that are utilized in research and development that have no alternative future use are expensed as incurred. Milestone payments related to the Company’s acquired (or in-licensed) assets are recorded as research and development expense when probable and can be reasonably estimated. Clinical Trial Accruals Expense accruals related to clinical trials are based on the Company’s estimates of services received and efforts expended pursuant to contracts with multiple research institutions and third-party clinical research organizations that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing costs, the Company estimates the period over which services will be performed and the level of effort to be expended in each period based upon patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Any estimates of the level of services performed or the costs of these services could differ from actual results. As of December 31, 2021, related to clinical trials, the Company recorded $0.8 million of accrued expenses and $1.4 million of prepaid expenses, which are reported in the consolidated balance sheet as components of accrued liabilities and prepaid expenses and other current assets, respectively. Net Loss per Share Basic and diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Company’s net income by the weighted average number of common shares outstanding and the impact of all potentially dilutive common shares. Diluted net loss per share is the same as basic net loss per share, as the effects of potentially dilutive securities are anti-dilutive for all periods presented. The following table sets forth the potential common shares excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive: Year Ended 2021 2020 Outstanding warrants 27,944,544 40,389,431 Outstanding options 7,059,842 4,688,625 Unvested restricted stock units — 143,000 Total 35,004,386 45,221,056 Income Taxes The Company accounts for income taxes by using an asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is recorded to the extent it is more likely than not that a deferred tax asset will not be realized. 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 operations in the period that includes the enactment date. The Company’s significant deferred tax assets are for net operating loss (“NOL”) carryforwards, tax credits, fixed assets, and intangible assets. The Company has provided a valuation allowance for its entire net deferred tax assets since inception as, due to its history of operating losses, the Company has concluded that it is more likely than not that its deferred tax assets will not be realized. The Company classifies interest and penalties arising from the underpayment of income taxes in the consolidated statements of operations and comprehensive loss as general and administrative expenses. No such expenses were recognized during the years ended December 31, 2021 and 2020 . Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases. Management uses one measurement of profitability and does not segregate its business for internal reporting. All tangible assets are held in the U.S. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards has had or will have a material impact on the Company's consolidated financial statements or disclosures. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
ACCRUED LIABILITIES | ACCRUED LIABILITIES Accrued liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued compensation $ 1,861 $ 1,369 Accrued contracted research and development services 823 3,733 Accrued professional fees 452 318 Total $ 3,136 $ 5,420 |
STRATEGIC AGREEMENTS
STRATEGIC AGREEMENTS | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
STRATEGIC AGREEMENTS | STRATEGIC AGREEMENTS Exclusive License and Development Agreement with Carna On February 2, 2022, the Company entered into an Exclusive License Agreement (the “Carna License Agreement”) with Carna Biosciences, Inc. (“Carna”), pursuant to which the Company acquired exclusive, worldwide rights to research, develop, and comme rcialize Carna’s portfolio of novel Stimulator of Interferon Genes (“STING”) inhibitors. In accordance with the terms of the Carna License Agreement, in exchange for the licensed rights, the Company made a one-time cash payment of $2.0 million. The Carna License Agreement provides that the Company will make success-based payments to Carna of up to $258.0 million in the aggregate contingent upon achievement of specified development, regulatory, and commercial milestones. Further, the Carna License Agreement provides that the Company will pay Carna tiered royalty payments ranging from mid-single digits up to 10% of net sales. All of the contingent payments and royalties are payable in cash in U.S. Dollars. Under the terms of the Carna License Agreement, the Company will be responsible for, and bear the future costs of, all development and commercialization activities, including patenting, related to all the licensed compounds. License and Development Agreement with Voronoi On August 27, 2021, the Company entered into a License and Development Agreement (the “Voronoi License Agreement”) with Voronoi Inc. (“Voronoi”), pursuant to which the Company acquired exclusive, worldwide rights to research, develop, and commercialize BBI-02, a novel, Phase 1-ready, potential first-in-class DYRK1A inhibitor, and other next-generation therapeutics developed from Voronoi’s proprietary kinase inhibitor platform. In accordance with the terms of the Voronoi License Agreement, in exchange for the license rights, the Company made a one-time payment of $2.5 million in cash and issued $2.0 million, or 2,816,901 shares, of its common stock to Voronoi. As a result, the Company recorded $4.8 million in research and development expenses during the year ended December 31, 2021. With respect to BBI-02, the Voronoi License Agreement provides that the Company will make payments to Voronoi of up to $211.0 million in the aggregate contingent upon achievement of specified development, regulatory, and commercial milestones. With respect to the next-generation compounds arising from the novel kinase inhibitor platform, the Company will make payments to Voronoi of up to $107.5 million in the aggregate contingent upon achievement of specified development, regulatory, and commercial milestones. Further, the Voronoi License Agreement provides that the Company will pay Voronoi tiered royalty payments ranging from low-single digits up to 10% of net sales of products arising from the in-licensed DYRK1A inhibitor programs and next-generation kinase inhibitor platform. All of the contingent payments and royalties are payable in cash in U.S. Dollars, except for $1.0 million of the development and regulatory milestone payments, which amount is payable in equivalent shares of the Company’s common stock. Under the terms of the Voronoi License Agreement, the Company will be responsible for, and bear the future costs of, all development and commercialization activities, including patenting, related to all the licensed compounds. Amended and Restated License Agreement with Bodor In February 2020, the Company, together with Brickell Subsidiary and Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor (collectively, “Bodor”) entered into an amended and restated license agreement (the “Amended and Restated License Agreement”), which supersedes the License Agreement, dated December 15, 2012, entered into between Brickell Subsidiary and Bodor, as amended by Amendment No. 1 to License Agreement, effective as of October 21, 2013, and Amendment No. 2 to License Agreement, effective as of March 31, 2015. The Amended and Restated License Agreement retains with the Company a worldwide, exclusive license to develop, manufacture, market, sell, and sublicense products containing the proprietary compound sofpironium bromide based upon the patents referenced in the Amended and Restated License Agreement for a defined field of use. As of December 31, 2021, under the original License Agreement and the Amended and Restated License Agreement, the Company had remaining obligations to pay Bodor (i) a royalty on sales of product outside of Japan and certain other Asian countries (the “Territory”), including a low single-digit royalty on sales of certain product not covered by the patent estate licensed from Bodor; (ii) approximately 50 to 55% of all royalties the Company receives from Kaken Pharmaceutical Co., Ltd. (“Kaken”) for sales of product within the Territory; (iii) a percentage of non-royalty sublicensing income the Company receives from Kaken or other sublicensees; and (iv) up to an aggregate of $0.8 million (plus an additional $0.1 million for approvals of additional products) in cash payments and $1.0 million of shares of the Company’s common stock upon the achievement of certain regulatory milestones. Under the terms of the Amended and Restated License Agreement, the Company made a $0.5 million milestone payment to Bodor following the closing of a public offering in June 2020 and accrued an additional $1.0 million related to its plan to initiate its U.S. Phase 3 pivotal program in the fourth quarter of 2020. As a result, the Company recorded $1.5 million as research and development expense in the consolidated statements of operations during the year ended December 31, 2020. No similar or associated research and development expense was incurred in the year ended December 31, 2021, but the Company paid Bodor the applicable amount with respect to the royalties it received from Kaken for sales of ECCLOCK in Japan during those periods. License, Development, and Commercialization Agreement with Kaken In March 2015, the Company entered into a license, development, and commercialization agreement (as amended, the “Kaken Agreement”) with Kaken. Under the Kaken Agreement, the Company granted to Kaken an exclusive right to develop, manufacture, and commercialize the Company’s sofpironium bromide compound in the Territory. In exchange, Kaken paid the Company an upfront, non-refundable payment of $11.0 million. In addition, the Company was entitled to receive aggregate payments of up to $10.0 million upon the achievement of specified development milestones, and $30.0 million upon the achievement of commercial milestones, as well as tiered royalties based on a percentage of net sales of licensed products in the Territory. The Kaken Agreement further provides that Kaken will be responsible for funding all development and commercial costs for the program in the Territory. Kaken was also required to enter into negotiations with the Company, to supply the Company, at cost, with clinical supplies to perform Phase 3 clinical trials in the U.S. In May 2018, the Company entered into an amendment to the Kaken Agreement, pursuant to which the Company received an upfront non-refundable fee of $15.6 million (the “Kaken R&D Payment”), which was initially recorded as deferred revenue, to provide the Company with research and development funds for the sole purpose of conducting certain clinical trials and other such research and development activities required to support the submission of a new drug application for sofpironium bromide. Upon receipt of the Kaken R&D Payment on May 31, 2018, a milestone payment originally due upon the first commercial sale in Japan was removed from the Kaken Agreement and all future royalties to the Company under the Kaken Agreement were reduced by 150 basis points. During the year ended December 31, 2020, the Company recognized revenue of $1.8 million related to the Kaken R&D Payment. The Kaken R&D Payment was recognized in full by the end of the third quarter of 2020. In September 2020, Kaken received regulatory approval in Japan to manufacture and market sofpironium bromide gel, 5% (ECCLOCK ® ) for the treatment of primary axillary hyperhidrosis, and as a result, the Company began recognizing royalty revenue earned on a percentage of net sales of ECCLOCK in Japan of $27 thousand during the fourth quarter of 2020. Prior to the fourth quarter of 2020, the Company had not recognized any royalty revenue from any collaboration arrangement. During the year ended December 31, 2021, the Company recognized royalty revenue of $0.4 million. |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
NOTE PAYABLE | NOTE PAYABLE On April 15, 2020, the Company executed an unsecured promissory note to IberiaBank (the “PPP Loan”) pursuant to the U.S. Small Business Administration’s Paycheck Protection Program (the “PPP”) under Division A, Title I of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The Company used the PPP Loan proceeds in the principal amount of $0.4 million and bearing interest at a fixed rate of 1.00% per annum to cover payroll costs and certain other permitted costs in accordance with the relevant terms and conditions of the CARES Act. In January 2021, the Company applied for forgiveness of the full amount of the PPP Loan, which was forgiven in full in June 2021. As a result, during the year ended December 31, 2021, the Company recognized a gain on extinguishment of debt of approximately $0.4 million in the consolidated statements of operations within the line “Investment and other income, net.” |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Operating Lease In August 2016, the Company entered into a multi-year, noncancelable lease for its Colorado-based office space, which was amended in June 2021 to, among other things, extend the lease term to December 31, 2022 (as amended, the “Boulder Lease”). Under the terms of the Boulder Lease, the Company may, at its option, renew the Boulder Lease for two additional terms of three years each, with monthly rent payments determined at the time of renewal at the lower of $6,076 per month or current market rental rates. The Company recognized a right-of-use asset and corresponding lease liability. Minimum base lease payments under the Boulder Lease are recognized on a straight-line basis over the full term of the lease. In addition to base rental payments included in the contractual obligations table below, the Company is responsible for its pro rata share of the operating expenses for the building, which includes common area maintenance, utilities, property taxes, and insurance. Upon modification of the Boulder Lease, the Company reassessed classification of the lease and determined that the lease still met the criteria to be classified as an operating lease. Furthermore, the Company remeasured the lease liability as of the effective date by calculating the present value of the new lease payments, discounted at the Company’s updated incremental borrowing rate of 11.0%, over the extended term of 18 months. The operating expenses are variable and thus not included in the present value determination of the lease liability. Because the Company was not reasonably certain to exercise the renewal option, the option was not considered in determining the lease term, and associated potential additional payments were excluded from lease payments. The following table presents lease cost, cash paid for amounts included in the measurement of lease liabilities, the weighted-average remaining lease term, and the weighted-average discount rate for the Company’s operating leases (in thousands): Year Ended 2021 2020 Operating lease cost $ 62 $ 53 Variable lease cost $ 37 $ 25 Cash outflows from operating leases $ 88 $ 84 Weighted-average remaining lease term 1.0 year 0.8 years Weighted-average discount rate 11 % 12 % The following is a summary of the contractual obligations related to operating lease commitments as of December 31, 2021, and the effect such obligations are expected to have on the Company’s liquidity and cash flows in future periods (in thousands): Total maturities, through December 31, 2022 $ 73 Less imputed interest (4) Present value of lease liability $ 69 |
CAPITAL STOCK
CAPITAL STOCK | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
CAPITAL STOCK | CAPITAL STOCK Common Stock On April 19, 2021, following approval by the Company’s stockholders, the Company filed an amendment to its amended and restated certificate of incorporation with the Secretary of State of the State of Delaware that increased the number of the Company’s authorized shares of common stock, par value $0.01 per share, from 100,000,000 to 300,000,000. Each share of the Company’s common stock is entitled to one vote, and the holders of the Company’s common stock are entitled to receive dividends when and as declared or paid by its board of directors. The Company had reserved authorized shares of common stock for future issuance at December 31, 2021 as follows: December 31, Common stock warrants 27,944,544 Common stock options outstanding 7,059,842 Shares available for grant under the Omnibus Plan 3,644,883 Shares available for grant under the Employee Stock Purchase Plan 2,450,715 Total 41,099,984 The Company may be limited in its ability to sell a certain number of shares of its common stock under the Purchase Agreement or ATM Agreements described below, depending on the availability at any given time of authorized and available shares of common stock. Public Offerings of Common Stock and Warrants In October 2021, the Company completed a sale of 30,263,400 shares of its common stock at a public offering price of $0.38 per share in an underwritten public offering (the “October 2021 Offering”). The October 2021 Offering resulted in net proceeds of approximately $10.3 million, after deducting the underwriting discount and offering expenses payable by the Company. The Company is using the net proceeds from the October 2021 Offering for research and development, including clinical trials, working capital, business development, and general corporate purposes. In July 2021, the Company completed a sale of 12,983,871 shares of its common stock at a public offering price of $0.62 per share in an underwritten public offering (the “July 2021 Offering”). The July 2021 Offering resulted in net proceeds of approximately $7.3 million, after deducting underwriting discounts and commissions and offering expenses. The Company is using the net proceeds from the July 2021 Offering for research and development, including clinical trials, working capital, and general corporate purposes. In October 2020, the Company completed a sale of 19,003,510 shares of its common stock, and, to certain investors, pre-funded warrants to purchase 1,829,812 shares of its common stock, and accompanying common stock warrants to purchase up to an aggregate of 20,833,322 shares of its common stock (the “October 2020 Offering”). Each share of common stock and pre-funded warrant to purchase one share of the Company’s common stock was sold together with a common warrant to purchase one share of the Company’s common stock. The public offering price of each share of the Company’s common stock and accompanying common warrant was $0.72 and $0.719 for each pre-funded warrant and accompanying common warrant, respectively. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The common warrants are exercisable at a price of $0.72 per share of the Company’s common stock and will expire five years from the date of issuance. The pre-funded warrants were exercised in October 2020 at an exercise price of $0.001 per share of the Company’s common stock. The October 2020 Offering resulted in net proceeds of approximately $13.7 million to the Company after deducting underwriting commissions and discounts and other offering expenses of $1.3 million and excluding the proceeds from the exercise of the warrants. During the year ended December 31, 2021, 12,427,387 common warrants associated with the October 2020 Offering were exercised at a weighted-average exercise price of $0.72 per share, resulting in aggregate proceeds of approximately $8.9 million. The Company is using the net proceeds from the October 2020 Offering for research and development, including clinical trials, working capital, and general corporate purposes. In June 2020, the Company completed a sale of 14,790,133 shares of its common stock, and, to certain investors, pre-funded warrants to purchase 2,709,867 shares of its common stock, and accompanying common stock warrants to purchase up to an aggregate of 17,500,000 shares of its common stock (the “June 2020 Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase one share of common stock. The public offering price of each share of common stock and accompanying common warrant was $1.15 and $1.149 for each pre-funded warrant and accompanying common warrant, respectively. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The pre-funded warrants were exercised in the third quarter of 2020 at an exercise price of $0.001 per share of common stock. The common warrants were immediately exercisable at a price of $1.25 per share of common stock and will expire five years from the date of issuance. The June 2020 Offering resulted in approximately $18.7 million of net proceeds to the Company after deducting underwriting commissions and discounts and other offering expenses of $1.4 million and excluding the proceeds from the exercise of the warrants. Certain officers of the Company participated in the June 2020 Offering by purchasing an aggregate purchase price of $0.2 million of the Company's common stock and warrants. During the year ended December 31, 2021, 17,500 common warrants associated with the June 2020 Offering were exercised at a weighted-average exercise price of $1.25 per share, resulting in aggregate proceeds of approximately $22 thousand. The Company is using the net proceeds from the June 2020 Offering for research and development, including clinical trials, working capital, and general corporate purposes. At Market Issuance Sales Agreements In March 2021, the Company entered into an At Market Issuance Sales Agreement (the “2021 ATM Agreement”) with Oppenheimer & Co. Inc. (“Oppenheimer”) and William Blair & Company, L.L.C. as the Company’s sales agents (the “Agents”). Pursuant to the terms of the 2021 ATM Agreement, the Company may sell from time to time through the Agents shares of its common stock having an aggregate offering price of up to $50.0 million. Such shares are issued pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-254037). Sales of the shares are made by means of ordinary brokers’ transactions on The Nasdaq Capital Market at market prices or as otherwise agreed by the Company and the Agents. Under the terms of the 2021 ATM Agreement, the Company may also sell the shares from time to time to an Agent as principal for its own account at a price to be agreed upon at the time of sale. Any sale of the shares to an Agent as principal would be pursuant to the terms of a separate placement notice between the Company and such Agent. During the year ended December 31, 2021, the Company sold 4,449,828 shares of its common stock under the 2021 ATM Agreement at a weighted-average price of $0.89 per share, for aggregate net proceeds of $3.8 million, after giving effect to a 3% commission to the Agents. As of December 31, 2021, approximately $46.0 million of shares of common stock were remaining, but had not yet been sold by the Company under the 2021 ATM Agreement. In April 2020, the Company entered into an At Market Issuance Sales Agreement (the “2020 ATM Agreement” and, together with the 2021 ATM Agreement, the “ATM Agreements”) with Oppenheimer as the Company’s sales agent. Pursuant to the terms of the 2020 ATM Agreement, the Company may sell from time to time through Oppenheimer shares of its common stock having an aggregate offering price of up to $8.0 million. Such shares are issued pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-236353). Sales of the shares are made by means of ordinary brokers’ transactions on The Nasdaq Capital Market at market prices or as otherwise agreed by the Company and Oppenheimer. Under the terms of the 2020 ATM Agreement, the Company may also sell the shares from time to time to Oppenheimer as principal for its own account at a price to be agreed upon at the time of sale. Any sale of the shares to Oppenheimer as principal would be pursuant to the terms of a separate placement notice between the Company and Oppenheimer. During the year ended December 31, 2021, the Company sold 1,089,048 shares of its common stock under the 2020 ATM Agreement at a weighted-average price of $1.55 per share, for aggregate net proceeds of approximately $1.6 million, after giving effect to a 3% commission to Oppenheimer as agent. As of December 31, 2021, approximately $2.6 million of shares of common stock were remaining, but had not yet been sold by the Company under the 2020 ATM Agreement. Private Placement Offerings In February 2020, the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into (i) a securities purchase agreement (the “Securities Purchase Agreement”); (ii) a purchase agreement (the “Purchase Agreement”); and (iii) a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Securities Purchase Agreement, Lincoln Park purchased, and the Company sold, (i) an aggregate of 950,000 shares of common stock (the “Common Shares”); (ii) a warrant to initially purchase an aggregate of up to 606,420 shares of common stock at an exercise price of $0.01 per share (the “Series A Warrant”); and (iii) a warrant to initially purchase an aggregate of up to 1,556,420 shares of common stock at an exercise price of $1.16 per share (the “Series B Warrant,” and together with the Series A Warrant, the “Warrants”). The aggregate gross purchase price for the Common Shares and the Warrants was $2.0 million. Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $28.0 million in the aggregate of shares of common stock. In order to retain maximum flexibility to issue and sell up to the maximum of $28.0 million of the Company’s common stock under the Purchase Agreement, the Company sought and, at its annual meeting on April 19, 2021, received, stockholder approval for the sale and issuance of common stock in connection with the Purchase Agreement under Nasdaq Listing Rule 5635(d). Sales of common stock by the Company will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on August 14, 2020 (the “Commencement Date”). Following the Commencement Date, under the Purchase Agreement, on any business day selected by the Company, the Company may direct Lincoln Park to purchase up to 100,000 shares of common stock on such business day (each, a “Regular Purchase”), provided, however, that (i) the Regular Purchase may be increased to up to 125,000 shares, provided that the closing sale price of the common stock is not below $3.00 on the purchase date; and (ii) the Regular Purchase may be increased to up to 150,000 shares, provided that the closing sale price of the common stock is not below $5.00 on the purchase date. In each case, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $1,000,000. The purchase price per share for each such Regular Purchase will be based on prevailing market prices of common stock immediately preceding the time of sale. In addition to Regular Purchases, the Company may direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the Purchase Agreement if it would result in Lincoln Park beneficially owning more than 9.99% of the outstanding shares of common stock. During the year ended December 31, 2021, the Company sold to Lincoln Park 1,300,000 shares under the Purchase Agreement at a weighted-average price of $0.81 per share, for aggregate net proceeds of $1.0 million. As of December 31, 2021, approximately $26.9 million of shares of common stock were remaining, but had not yet been sold by the Company under the Purchase Agreement. The Company agreed with Lincoln Park that it will not enter into any “variable rate” transactions with any third party, subject to certain exceptions, for a period defined in the Purchase Agreement. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. The Securities Purchase Agreement, the Purchase Agreement, and the Registration Rights Agreement contain customary representations, warranties, agreements, and conditions to completing future sale transactions, indemnification rights, and obligations of the parties. Preferred Stock |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION Equity Incentive Plans On April 20, 2020, the Company’s stockholders approved the 2020 Omnibus Long-Term Incentive Plan (the “Omnibus Plan”), which replaced, with respect to new award grants, the Company’s 2009 Equity Incentive Plan, as amended and restated (the “2009 Plan”), and the Vical Equity Incentive Plan (the “Vical Plan”) (collectively, the “Prior Plans”) that were previously in effect. Following the approval of the Omnibus Plan on April 20, 2020, no further awards were available to be issued under the Prior Plans, but awards outstanding under those plans as of that date remain outstanding in accordance with their terms. As of December 31, 2021, 1,247,497 and 117,180 shares were subject to outstanding awards under the 2009 Plan and Vical Plan, respectively. As of December 31, 2021, 9,125,000 shares were authorized and 5,695,165 shares were subject to outstanding awards under the Omnibus Plan. On August 31, 2020 and April 19, 2021, the Company’s stockholders approved increases in the number of shares of common stock authorized for issuance under the Omnibus Plan by 4,500,000 and 4,000,000 shares, respectively. As of December 31, 2021, 3,644,883 shares remained available for grant under the Omnibus Plan. Fair Value Assumptions The Company accounts for share-based compensation expense for stock options granted to employees, members of its board of directors, and non-employees by estimating the fair value of each stock-based award on the date of grant using the Black-Scholes option pricing model. The Company recognizes share-based compensation expense on a straight-line basis over the vesting term. The determination of the fair value of stock-based awards on the date of grant using an option-pricing model is affected by the value of the Company’s stock price, as well as assumptions regarding subjective variables. These variables include expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rate, and expected dividends. Because the Company has a limited history of stock purchase and sale activity, the Company estimates expected volatility of the common stock by using the average share fluctuations of companies similar in size, operations, and life cycle. The expected term of stock options granted to employees, including members of the board of directors, is determined as the midpoint between the vesting date and the contractual end of the option grant. The expected term of all other stock options granted is based on the Company’s historical share option exercise experience, which approximates the midpoint between the vesting date and the contractual end of the option grant. The risk-free interest rates used in the valuation model are based on U.S. Treasury yield issues in effect at the time of grant for a period commensurate with the expected term of the grant. The Company does not anticipate paying any dividends in the foreseeable future and therefore uses an expected dividend yield of zero. Management has estimated a forfeiture rate of 11% based on past history, forfeiture rates, and the individuals receiving the options. The Company monitors actual forfeiture experience and periodically updates forfeiture estimates based on actual experience. Stock Options Stock options granted by the Company have an exercise price per share equal to the closing sales price of the common stock on the day prior to the date of grant and expire ten years from the date of grant. The vesting term of granted stock options is stated in each individual grant agreement, which is generally four years. During the years ended December 31, 2021 and December 31, 2020, the Company granted stock options with a weighted-average grant date fair value of $0.65 per share and $0.52 per share, respectively. The assumptions used to calculate the fair value of stock options granted are as follows, presented on a weighted-average basis: Year Ended 2021 2020 Expected term 6.0 years 6.0 years Expected volatility 99.3% 73.0% Risk-free interest rate 1.0% 0.4% Expected dividend yield —% —% A summary of stock option activity under the Company’s incentive plans is as follows: Shares Weighted Total Weighted Average Outstanding as of December 31, 2020 4,688,625 $ 4.66 $ — 9.04 Granted 2,645,000 $ 0.89 Exercised — $ — Forfeited (219,731) $ 1.57 Expired (54,052) $ 23.01 Outstanding as of December 31, 2021 7,059,842 $ 3.20 $ — 8.53 Options vested and exercisable as of December 31, 2021 2,013,110 $ 8.13 $ — 7.26 Options outstanding as of December 31, 2021 and expected to vest 4,291,193 $ 1.27 $ — 9.02 As of December 31, 2021, the Company had $3.6 million of total unrecognized share-based compensation expense related to stock options, which is expected to be recognized over a weighted-average period of approximately 2.9 years. Restricted Stock Units Restricted stock unit (“RSU”) activity during the year ended December 31, 2021 is shown below. Shares Weighted Average Grant Date Fair Value Unvested as of December 31, 2020 143,000 $ 1.38 Granted 47,435 $ 0.78 Vested (189,435) $ 1.23 Forfeited (1,000) $ 1.38 Unvested as of December 31, 2021 — $ — The total grant date fair value and the total vest date fair value of RSUs vested during the year ended December 31, 2021 were both approximately $0.2 million. As of December 31, 2021, the Company had no unrecognized share-based compensation expense related to service-condition RSU awards. Employee Stock Purchase Plan On April 19, 2021, the Company’s stockholders approved the Brickell Biotech, Inc. Employee Stock Purchase Plan (the “ESPP”), which had a first eligible purchase period commencing on July 1, 2021. The ESPP allows qualified employees to purchase shares of the Company’s common stock at a price per share equal to 85% of the lower of: (i) the closing price of the Company’s common stock on the first trading day of the applicable purchase period or (ii) the closing price of the Company’s common stock on the last trading day of the applicable purchase period. New six-month purchase periods begin each January 1 and July 1. As of December 31, 2021, the Company had 2,450,715 shares available for issuance and 149,285 cumulative shares had been issued under the ESPP. Stock-Based Compensation Expense Total stock-based compensation expense reported in the consolidated statements of operations was allocated as follows (in thousands): Year Ended 2021 2020 Research and development $ 478 $ 392 General and administrative 1,785 1,601 Total stock-based compensation expense $ 2,263 $ 1,993 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES During the years ended December 31, 2021 and 2020, the Company recorded no income tax benefits for the NOL incurred in each year, due to its uncertainty of realizing a benefit from those items. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended 2021 2020 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 4.93 3.80 Research and development tax credits 2.22 0.11 Permanent differences and other 1.29 0.18 Stock-based compensation (0.36) (1.35) Change in tax rate — (0.32) Change in deferred tax asset valuation allowance (29.08) (23.42) Effective income tax rate — % — % Approximate deferred tax assets (liabilities) resulting from timing differences between financial and tax bases were associated with the following items (in thousands): Year Ended 2021 2020 NOL carryforwards $ 100,831 $ 90,035 Research and development and other tax credits 16,881 15,566 Depreciable assets 6,481 8,356 Accrued expenses 95 818 Intangible assets 1,470 361 Stock-based compensation 1,238 373 Other 15 22 Net deferred tax asset 127,011 115,531 Less: valuation allowance (127,011) (115,531) Net deferred tax assets $ — $ — As of December 31, 2021, the Company had deferred tax assets of $127.0 million. Due to uncertainties surrounding the Company’s ability to generate future taxable income to realize these assets, a full valuation allowance has been established to offset the net deferred tax asset. Pursuant to Sections 382 and 383 of the Internal Revenue Code (“IRC”), annual use of the Company’s NOL and credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The most recent Section 382 analysis was completed through December 31, 2011 as a result of a previous ownership change on December 29, 2006, as determined per the provisions of Section 382 of the IRC as a result of various stock issuances used to finance the Company’s operations. Such ownership change resulted in annual limitations on the utilization of tax attributes, including NOL carryforwards and tax credits. A Section 382 analysis has not been conducted for the period between January 1, 2012 through December 31, 2021. As such, the Company cannot provide any assurance that a change in ownership within the meaning of the IRC has not occurred between those dates. If a change in ownership were to have occurred, additional NOL and tax credit carryforwards could be eliminated or restricted. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. As of December 31, 2021 and 2020, the Company had available federal NOL carryforwards of approximately $455.9 million and $420.8 million, respectively. The NOLs generated after 2017, totaling $134.4 million, will carry forward indefinitely and be available to offset up to 80% of future taxable income each year. NOLs generated before 2018, totaling $321.5 million, will expire from 2022 through 2037. In addition, the Company had federal research and development credits and orphan drug credit carryforwards of $26.6 million and $27.7 million as of December 31, 2021 and 2020, respectively, to reduce future federal income taxes, if any. The Company also has available state NOL carryforwards of approximately $429.0 million and $382.7 million as of December 31, 2021 and 2020, respectively. All federal and state NOL and credit carryforwards listed above are reflected before the reduction for amounts effectively eliminated under Sections 382 and 383. Based upon statute, federal and state NOLs and credits are expected to expire as follows (in thousands): Expiration Date: Federal NOLs State NOLs Federal R&D Credit Federal Orphan Drug Credit State R&D Credit 2022 22,420 — 483 1,610 — 2023 22,398 — 322 929 — 2024 25,032 — 213 663 — 2025 27,190 — 456 507 — 2026 and thereafter 224,441 389,944 8,066 13,306 — Indefinite 134,424 39,084 — — 9,572 Totals $ 455,905 $ 429,028 $ 9,540 $ 17,015 $ 9,572 The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2021 and 2020. Management reevaluates the positive and negative evidence at each reporting period. The Company’s valuation allowance increased by approximately $11.5 million for the year ended December 31, 2021. For the year ended December 31, 2020, the valuation allowance increased by $4.9 million. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes that it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcome of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company had previously acquired gross unrecognized tax benefits with a balance of $21.7 million as of each of December 31, 2021 and 2020, none of which would affect the effective tax rate, due to the Company’s full valuation allowance on its deferred tax assets. The Company does not anticipate any significant decreases in its unrecognized tax benefits over the next 12 months. The Company’s policy is to recognize the interest expense and/or penalties related to income tax matters as a component of income tax expense. The Company had no accrual for interest or penalties on its consolidated balance sheets as of December 31, 2021 and 2020, and has not recognized interest and/or penalties in its consolidated statements of operations for the years ended December 31, 2021 and 2020. As of December 31, 2021, the Company’s U.S. federal and state tax returns remain subject to examination by tax authorities beginning with the tax year ended December 31, 2018. However, due to NOLs and credit carryforwards being generated and carried forward from prior tax years, substantially all tax years may also be subject to examination. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Brickell Subsidiary, Inc., and are presented in United States (“U.S.”) dollars and prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which include all adjustments necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods presented. All significant intercompany balances have been eliminated in consolidation. The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. The Company’s management performed an evaluation of its activities through the date of filing of these financial statements and concluded that there are no subsequent events requiring disclosure, other than as disclosed. |
Use of Estimates | Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. GAAP, which requires it to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid debt instruments with an original maturity of three months or less from date of purchase to be cash equivalents. Cash equivalents, which are stated at cost, consist primarily of amounts held in short-term money market accounts with highly rated financial institutions. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash and cash equivalents balances in several accounts with one financial institution which, from time to time, are in excess of federally insured limits. |
Property and Equipment | Property and EquipmentProperty and equipment is stated at cost, less accumulated depreciation. Expenditures for major betterments and additions are charged to the asset accounts, while replacements, maintenance, and repairs, which do not improve or extend the lives of the respective assets, are charged to expense as incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years. |
Fair Value Measurements | Fair Value Measurements Fair value is the price that the Company would receive to sell an asset or pay to transfer a liability in a timely transaction with an independent counterparty in the principal market, or in the absence of a principal market, the most advantageous market for the asset or liability. A three-tier hierarchy distinguishes between (1) inputs that reflect the assumptions market participants would use in pricing an asset or liability developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (2) inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing an asset or liability developed based on the best information available in the circumstances (unobservable inputs). The hierarchy is summarized in the three broad levels listed below: Level 1 —quoted prices in active markets for identical assets and liabilities Level 2 —other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.) Level 3 —significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities) |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company does not currently hold any financing leases. The Company has elected the practical expedient not to recognize on the balance sheet leases with terms of one year or less and not to separate lease components and non-lease components for long-term real estate leases. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company estimates the incremental borrowing rate based on industry peers in determining the present value of lease payments. Industry peers consist of several public companies in the biotechnology industry with |
Revenue Recognition | Revenue Recognition The Company currently recognizes revenue primarily from licensing and royalty fees received under the Kaken Agreement described in Note 3. “Strategic Agreements,” of which the terms of the agreement include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones, and royalties on net product sales. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company utilizes judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Collaboration Revenue The Company evaluates collaboration arrangements to determine whether units of account within the collaboration arrangement exhibit the characteristics of a vendor and customer relationship. Licenses of Intellectual Property If a license for the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, and other revenues and earnings in the period of adjustment and future periods through the end of the performance obligation period. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). |
Research and Development | Research and Development Research and development costs are charged to expense when incurred and consist of costs incurred for independent and collaboration research and development activities. The major components of research and development costs include formulation development, nonclinical studies, clinical studies, clinical manufacturing costs, in-licensing fees for development-stage assets, salaries and employee benefits, and allocations of various overhead and occupancy costs. Research costs typically consist of applied research, preclinical, and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis, and the transfer and scale-up of manufacturing at contract manufacturers. Assets acquired (or in-licensed) that are utilized in research and development that have no alternative future use are expensed as incurred. Milestone payments related to the Company’s acquired (or in-licensed) assets are recorded as research and development expense when probable and can be reasonably estimated. |
Clinical Trial Accruals | Clinical Trial Accruals Expense accruals related to clinical trials are based on the Company’s estimates of services received and efforts expended pursuant to contracts with multiple research institutions and third-party clinical research organizations that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing costs, the Company estimates the period over which services will be performed and the level of effort to be expended in each period based upon patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Any estimates of the level of services performed or the costs of these services could differ from actual results. As of December 31, 2021, related to clinical trials, the Company recorded $0.8 million of accrued expenses and $1.4 million of prepaid expenses, which are reported in the consolidated balance sheet as components of accrued liabilities and prepaid expenses and other current assets, respectively. |
Net Loss per Common Share | Net Loss per Share Basic and diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Company’s net income by the weighted average number of common shares outstanding and the impact of all potentially dilutive common shares. Diluted net loss per share is the same as basic net loss per share, as the effects of potentially dilutive securities are anti-dilutive for all periods presented. |
Income Taxes | Income Taxes The Company accounts for income taxes by using an asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is recorded to the extent it is more likely than not that a deferred tax asset will not be realized. 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 operations in the period that includes the enactment date. The Company’s significant deferred tax assets are for net operating loss (“NOL”) carryforwards, tax credits, fixed assets, and intangible assets. The Company has provided a valuation allowance for its entire net deferred tax assets since inception as, due to its history of operating losses, the Company has concluded that it is more likely than not that its deferred tax assets will not be realized. The Company classifies interest and penalties arising from the underpayment of income taxes in the consolidated statements of operations and comprehensive loss as general and administrative expenses. No such expenses were recognized during the years ended December 31, 2021 and 2020 . |
Segment Data | Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases. Management uses one measurement of profitability and does not segregate its business for internal reporting. All tangible assets are held in the U.S. |
New Accounting Pronouncements | New Accounting PronouncementsFrom time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards has had or will have a material impact on the Company's consolidated financial statements or disclosures |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Fair Value Measurements, Recurring and Nonrecurring | The following table sets forth the fair value of the Company’s financial assets measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): Level 1 (1) December 31, 2021 2020 Assets: Money market funds $ 25,875 $ 29,182 ____________ (1) No assets as of each respective date were identified as Level 2 or 3 based on the three-tier fair value hierarchy. The Company had no financial liabilities measured at fair value on a recurring basis as of each respective date. |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following table sets forth the potential common shares excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive: Year Ended 2021 2020 Outstanding warrants 27,944,544 40,389,431 Outstanding options 7,059,842 4,688,625 Unvested restricted stock units — 143,000 Total 35,004,386 45,221,056 |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued compensation $ 1,861 $ 1,369 Accrued contracted research and development services 823 3,733 Accrued professional fees 452 318 Total $ 3,136 $ 5,420 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Lease, Cost | The following table presents lease cost, cash paid for amounts included in the measurement of lease liabilities, the weighted-average remaining lease term, and the weighted-average discount rate for the Company’s operating leases (in thousands): Year Ended 2021 2020 Operating lease cost $ 62 $ 53 Variable lease cost $ 37 $ 25 Cash outflows from operating leases $ 88 $ 84 Weighted-average remaining lease term 1.0 year 0.8 years Weighted-average discount rate 11 % 12 % |
Schedule of Contractual Obligations | The following is a summary of the contractual obligations related to operating lease commitments as of December 31, 2021, and the effect such obligations are expected to have on the Company’s liquidity and cash flows in future periods (in thousands): Total maturities, through December 31, 2022 $ 73 Less imputed interest (4) Present value of lease liability $ 69 |
CAPITAL STOCK (Tables)
CAPITAL STOCK (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Reserved Authorized Shares of Common Stock | The Company had reserved authorized shares of common stock for future issuance at December 31, 2021 as follows: December 31, Common stock warrants 27,944,544 Common stock options outstanding 7,059,842 Shares available for grant under the Omnibus Plan 3,644,883 Shares available for grant under the Employee Stock Purchase Plan 2,450,715 Total 41,099,984 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Valuation Assumptions | The assumptions used to calculate the fair value of stock options granted are as follows, presented on a weighted-average basis: Year Ended 2021 2020 Expected term 6.0 years 6.0 years Expected volatility 99.3% 73.0% Risk-free interest rate 1.0% 0.4% Expected dividend yield —% —% |
Schedule of Stock Option Activity | A summary of stock option activity under the Company’s incentive plans is as follows: Shares Weighted Total Weighted Average Outstanding as of December 31, 2020 4,688,625 $ 4.66 $ — 9.04 Granted 2,645,000 $ 0.89 Exercised — $ — Forfeited (219,731) $ 1.57 Expired (54,052) $ 23.01 Outstanding as of December 31, 2021 7,059,842 $ 3.20 $ — 8.53 Options vested and exercisable as of December 31, 2021 2,013,110 $ 8.13 $ — 7.26 Options outstanding as of December 31, 2021 and expected to vest 4,291,193 $ 1.27 $ — 9.02 |
Share-based Compensation Arrangements by Share-based Payment Award | Restricted stock unit (“RSU”) activity during the year ended December 31, 2021 is shown below. Shares Weighted Average Grant Date Fair Value Unvested as of December 31, 2020 143,000 $ 1.38 Granted 47,435 $ 0.78 Vested (189,435) $ 1.23 Forfeited (1,000) $ 1.38 Unvested as of December 31, 2021 — $ — |
Schedule of Share-Based Compensation Expense | Total stock-based compensation expense reported in the consolidated statements of operations was allocated as follows (in thousands): Year Ended 2021 2020 Research and development $ 478 $ 392 General and administrative 1,785 1,601 Total stock-based compensation expense $ 2,263 $ 1,993 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended 2021 2020 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 4.93 3.80 Research and development tax credits 2.22 0.11 Permanent differences and other 1.29 0.18 Stock-based compensation (0.36) (1.35) Change in tax rate — (0.32) Change in deferred tax asset valuation allowance (29.08) (23.42) Effective income tax rate — % — % |
Schedule of Deferred Tax Assets and Liabilities | Approximate deferred tax assets (liabilities) resulting from timing differences between financial and tax bases were associated with the following items (in thousands): Year Ended 2021 2020 NOL carryforwards $ 100,831 $ 90,035 Research and development and other tax credits 16,881 15,566 Depreciable assets 6,481 8,356 Accrued expenses 95 818 Intangible assets 1,470 361 Stock-based compensation 1,238 373 Other 15 22 Net deferred tax asset 127,011 115,531 Less: valuation allowance (127,011) (115,531) Net deferred tax assets $ — $ — |
Summary of Federal and State Carryforwards and Credits Maturity | All federal and state NOL and credit carryforwards listed above are reflected before the reduction for amounts effectively eliminated under Sections 382 and 383. Based upon statute, federal and state NOLs and credits are expected to expire as follows (in thousands): Expiration Date: Federal NOLs State NOLs Federal R&D Credit Federal Orphan Drug Credit State R&D Credit 2022 22,420 — 483 1,610 — 2023 22,398 — 322 929 — 2024 25,032 — 213 663 — 2025 27,190 — 456 507 — 2026 and thereafter 224,441 389,944 8,066 13,306 — Indefinite 134,424 39,084 — — 9,572 Totals $ 455,905 $ 429,028 $ 9,540 $ 17,015 $ 9,572 |
ORGANIZATION AND NATURE OF OP_2
ORGANIZATION AND NATURE OF OPERATIONS - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Net loss | $ 39,474 | $ 20,913 | |
Net cash used in operating activities | 36,148 | 20,034 | |
Cash and cash equivalents | 26,884 | 30,115 | |
Accumulated deficit | $ 145,367 | $ 105,893 | |
October 2021 Offering | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Consideration received on transaction | $ 10,300 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | |
Property, Plant and Equipment [Line Items] | ||
Number of operating segments | segment | 1 | |
Depreciation | $ 22 | $ 10 |
Clinical trials, accrued liabilities, current | 800 | |
Other prepaid expense, clinical trials, current | $ 1,400 | |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | three | |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | five |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value of Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Assets: | ||
Money market funds | $ 25,875 | $ 29,182 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
May 31, 2018 | Mar. 31, 2015 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | $ 404,000 | $ 1,822,000 | ||||
Royalty revenue | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | 404,000 | $ 27,000 | ||||
Collaborative Arrangement | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Non-refundable upfront fees | $ 15,600,000 | $ 11,000,000 | ||||
Development milestone payments | 10,000,000 | |||||
Commercialization milestone payments | $ 30,000,000 | |||||
Basis point reduction | 1.50% | |||||
Revenue recognized | $ 1,800,000 | |||||
Collaborative Arrangement | Royalty revenue | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | $ 27,000 | $ 0 | $ 400,000 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Common Shares Excluded from EPS Calculations (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 35,004,386 | 45,221,056 |
Outstanding warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 27,944,544 | 40,389,431 |
Outstanding options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 7,059,842 | 4,688,625 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 0 | 143,000 |
ACCRUED LIABILITIES - Summary o
ACCRUED LIABILITIES - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 1,861 | $ 1,369 |
Accrued contracted research and development services | 823 | 3,733 |
Accrued professional fees | 452 | 318 |
Total | $ 3,136 | $ 5,420 |
STRATEGIC AGREEMENTS (Details)
STRATEGIC AGREEMENTS (Details) | Aug. 27, 2021USD ($)shares | May 31, 2018USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Feb. 22, 2022USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Issuance of common stock under license agreement | $ 1,971,000 | $ 500,000 | ||||||
Research and development | 28,231,000 | 11,216,000 | ||||||
Research and development expense, future payment, payment two | $ 107,500,000 | |||||||
Milestone payment | 1,000,000 | |||||||
Total revenue | 404,000 | 1,822,000 | ||||||
Royalty revenue | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenue | 404,000 | $ 27,000 | ||||||
Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Non-refundable upfront fees | $ 15,600,000 | $ 11,000,000 | ||||||
Development milestone payments | 10,000,000 | |||||||
Commercialization milestone payments | $ 30,000,000 | |||||||
Basis point reduction | 1.50% | |||||||
Total revenue | $ 1,800,000 | |||||||
Collaborative Arrangement | Royalty revenue | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenue | $ 27,000 | $ 0 | 400,000 | |||||
Carna Biosciences, Inc. | Subsequent Event | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Collaborative arrangement, rights and obligations, one-time cash payment | $ 2,000,000 | |||||||
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments | $ 258,000,000 | |||||||
Collaborative arrangement, rights and obligations, royalty payments, percent of net sales | 0.10 | |||||||
Voronoi Inc. | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Payments to acquire intangible assets | 2,500,000 | |||||||
Issuance of common stock under license agreement | $ 2,000,000 | |||||||
Issuance of common stock under license agreement (in shares) | shares | 2,816,901 | |||||||
Research and development | 4,800,000 | |||||||
Research and development expense, future payment, payment one | $ 211,000,000 | |||||||
Bodor Laboratories, Inc. | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Research and development | $ 1,000,000 | 0 | 1,500,000 | |||||
Milestone payment | $ 500,000 | |||||||
Cash payment | 800,000 | |||||||
Payments for additional product approval | 100,000 | |||||||
Value of shares issued in agreement | $ 1,000,000 |
NOTE PAYABLE - Narrative (Detai
NOTE PAYABLE - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Apr. 15, 2020 | |
Debt Instrument [Line Items] | |||
Gain on extinguishment of debt | $ 437 | $ 0 | |
Paycheck Protection Program | |||
Debt Instrument [Line Items] | |||
Face amount | $ 400 | ||
Stated rate | 1.00% |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) | 12 Months Ended | |
Dec. 31, 2021renewalTerm | Jan. 01, 2022USD ($) | |
Gain Contingencies [Line Items] | ||
Number of additional terms | renewalTerm | 2 | |
Renewal term | 3 years | |
Discount rate | 11.00% | |
Extended lease term | 18 months | |
Forecast | ||
Gain Contingencies [Line Items] | ||
Monthly payment, thereafter | $ | $ 6,076 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Schedule of Contractual Obligations (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Total maturities, through December 31, 2022 | $ 73 |
Less imputed interest | (4) |
Present value of lease liability | $ 69 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Lease Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 62 | $ 53 |
Variable lease cost | 37 | 25 |
Cash outflows from operating leases | $ 88 | $ 84 |
Weighted-average remaining lease term | 1 year | 9 months 18 days |
Weighted-average discount rate | 11.00% | 12.00% |
CAPITAL STOCK - Narrative (Deta
CAPITAL STOCK - Narrative (Details) | 1 Months Ended | 12 Months Ended | ||||||||
Oct. 31, 2021USD ($)$ / sharesshares | Jul. 31, 2021USD ($)$ / sharesshares | Oct. 31, 2020USD ($)$ / sharesshares | Jun. 30, 2020USD ($)$ / sharesshares | Feb. 29, 2020USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Apr. 19, 2021shares | Mar. 31, 2021USD ($) | Apr. 30, 2020USD ($) | |
Class of Stock [Line Items] | ||||||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | ||||||||
Common stock, shares authorized | 300,000,000 | 100,000,000 | 300,000,000 | |||||||
Sale of stock, expiration term | 5 years | |||||||||
Proceeds from the exercise of warrants | $ | $ 8,969,000 | $ 26,000 | ||||||||
Common stock, shares issued | 119,377,286 | 53,551,461 | ||||||||
Aggregate purchase price for stock and warrants | $ | $ 200,000 | |||||||||
Sale of stock, percentage of commission | 0.03 | |||||||||
Sale of stock additional shares authorized amount | $ | $ 26,900,000 | |||||||||
Preferred shares authorized | 5,000,000 | |||||||||
Temporary equity, par or stated value per share (in dollars per share) | $ / shares | $ 0.01 | |||||||||
Preferred stock shares outstanding | 0 | |||||||||
Lincoln Park | ||||||||||
Class of Stock [Line Items] | ||||||||||
Purchase obligation | $ | $ 28,000,000 | |||||||||
Purchase obligation, term | 36 months | |||||||||
Maximum commitment purchase amount | $ | $ 1,000,000 | |||||||||
Percentage of ownership after transaction | 9.99% | |||||||||
Common stock warrants | ||||||||||
Class of Stock [Line Items] | ||||||||||
Exercise price (in usd per share) | $ / shares | $ 0.72 | |||||||||
Pre-Funded Warrant | ||||||||||
Class of Stock [Line Items] | ||||||||||
Exercise price (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||||
October 2021 Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 30,263,400 | |||||||||
Closing sale price (in usd per share) | $ / shares | $ 0.38 | |||||||||
Consideration received on transaction | $ | $ 10,300,000 | |||||||||
July 2021 Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 12,983,871 | |||||||||
Closing sale price (in usd per share) | $ / shares | $ 0.62 | |||||||||
Consideration received on transaction | $ | $ 7,300,000 | |||||||||
October 2020 Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Consideration received on transaction | $ | $ 13,700,000 | |||||||||
Number of shares authorized to be repurchased | 20,833,322 | |||||||||
Exercise price (in usd per share) | $ / shares | $ 0.72 | |||||||||
Commissions discounts and other offering expenses | $ | $ 1,300,000 | |||||||||
Stock issuable upon warrants (in shares) | 12,427,387 | |||||||||
Proceeds from the exercise of warrants | $ | $ 8,900,000 | |||||||||
October 2020 Offering | Common Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 19,003,510 | |||||||||
October 2020 Offering | Common stock warrants | ||||||||||
Class of Stock [Line Items] | ||||||||||
Closing sale price (in usd per share) | $ / shares | $ 0.72 | |||||||||
Number of shares authorized to be repurchased | 1,829,812 | |||||||||
October 2020 Offering | Pre-Funded Warrant | ||||||||||
Class of Stock [Line Items] | ||||||||||
Closing sale price (in usd per share) | $ / shares | $ 0.719 | |||||||||
Common Stock Public Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Exercise price (in usd per share) | $ / shares | $ 1.25 | $ 1.25 | ||||||||
Sale of stock, expiration term | 5 years | |||||||||
Stock issuable upon warrants (in shares) | 17,500 | |||||||||
Proceeds from the exercise of warrants | $ | $ 22,000 | |||||||||
Common stock, shares issued | 14,790,133 | |||||||||
Net proceeds from common stock public offering | $ | $ 18,700,000 | |||||||||
Underwriting commissions, discounts, and other offering expenses | $ | $ 1,400,000 | |||||||||
Common Stock Public Offering | Pre-Funded Warrant | ||||||||||
Class of Stock [Line Items] | ||||||||||
Stock issuable upon warrants (in shares) | 2,709,867 | |||||||||
Public offering price (in usd per share) | $ / shares | $ 1.15 | |||||||||
Common Stock Public Offering | Accompanying Common Warrant | ||||||||||
Class of Stock [Line Items] | ||||||||||
Stock issuable upon warrants (in shares) | 17,500,000 | |||||||||
Public offering price (in usd per share) | $ / shares | $ 1.149 | |||||||||
2020 At Market Issuance Sales Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Consideration received on transaction | $ | $ 1,600,000 | |||||||||
Aggregate offering price | $ | $ 8,000,000 | |||||||||
Sale of stock, weighted average price per share (in usd per share) | $ / shares | $ 1.55 | |||||||||
Sale of stock additional shares authorized amount | $ | $ 2,600,000 | |||||||||
2020 At Market Issuance Sales Agreement | Common Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 1,089,048 | |||||||||
Private Placement Offerings | ||||||||||
Class of Stock [Line Items] | ||||||||||
Common stock, shares issued | 950,000 | |||||||||
Aggregate gross purchase price | $ | $ 2,000,000 | |||||||||
Private Placement Offerings | Series A | ||||||||||
Class of Stock [Line Items] | ||||||||||
Exercise price (in usd per share) | $ / shares | $ 0.01 | |||||||||
Stock issuable upon warrants (in shares) | 606,420 | |||||||||
Private Placement Offerings | Series B | ||||||||||
Class of Stock [Line Items] | ||||||||||
Exercise price (in usd per share) | $ / shares | $ 1.16 | |||||||||
Stock issuable upon warrants (in shares) | 1,556,420 | |||||||||
Purchase Agreement | Lincoln Park | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 1,300,000 | |||||||||
Closing sale price (in usd per share) | $ / shares | $ 3 | |||||||||
Consideration received on transaction | $ | $ 1,000,000 | |||||||||
Sale of stock, weighted average price per share (in usd per share) | $ / shares | $ 0.81 | |||||||||
Maximum shares allowed to be purchased | 100,000 | |||||||||
Maximum share increase amount | 125,000 | |||||||||
Regular Purchase | Lincoln Park | ||||||||||
Class of Stock [Line Items] | ||||||||||
Closing sale price (in usd per share) | $ / shares | $ 5 | |||||||||
Maximum share increase amount | 150,000 | |||||||||
2021 At Market Issuance Sales Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Consideration received on transaction | $ | $ 3,800,000 | |||||||||
Aggregate offering price | $ | $ 50,000,000 | |||||||||
Sale of stock, weighted average price per share (in usd per share) | $ / shares | $ 0.89 | |||||||||
Sale of stock additional shares authorized amount | $ | $ 46,000,000 | |||||||||
2021 At Market Issuance Sales Agreement | Pre-Funded Warrant | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 4,449,828 |
CAPITAL STOCK - Reserved Author
CAPITAL STOCK - Reserved Authorized Shares of Common Stock (Details) - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuance | 41,099,984 | |
Outstanding warrants | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuance | 27,944,544 | |
Common stock options outstanding | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuance | 7,059,842 | |
Outstanding options | 2020 Omnibus Plan | ||
Class of Stock [Line Items] | ||
Shares available for grant | 3,644,883 | |
Employee Stock | ||
Class of Stock [Line Items] | ||
Shares available for grant | 2,450,715 |
STOCK-BASED COMPENSATION - Narr
STOCK-BASED COMPENSATION - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | Apr. 19, 2021 | Aug. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Estimated forfeiture rate | 11.00% | |||
Stock purchase offering period | 6 months | |||
2020 Omnibus Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares authorized | 9,125,000 | |||
Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares issued in period | 149,285 | |||
Outstanding options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options outstanding (in shares) | 7,059,842 | 4,688,625 | ||
Granted (in shares) | 2,645,000 | |||
Share-based compensation arrangement by share-based payment award, award vesting period | 10 years | |||
Weighted-average grant date fair value (in dollars per share) | $ 0.65 | $ 0.52 | ||
Weighted average exercise price, granted (in usd per share) | $ 0.89 | |||
Unrecognized share-based compensation expense | $ 3.6 | |||
Unrecognized share-based compensation expense, period for recognition | 2 years 10 months 24 days | |||
Outstanding options | 2009 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options outstanding (in shares) | 1,247,497 | |||
Outstanding options | Vical Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options outstanding (in shares) | 117,180 | |||
Outstanding options | 2020 Omnibus Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options outstanding (in shares) | 5,695,165 | |||
Shares of common stock reserved for future issuance | 4,500,000 | |||
Number of additional shares authorized | 4,000,000 | |||
Shares available for grant | 3,644,883 | |||
Unvested restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized share-based compensation expense | $ 0 | |||
Aggregate intrinsic value vested | 0.2 | |||
Aggregate intrinsic value outstanding | $ 0.2 | |||
Employee Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for grant | 2,450,715 | |||
Employee Stock | Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Discount from market price, purchase date | 85.00% |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair Value Assumptions (Details) - Weighted average | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years | 6 years |
Expected volatility | 99.30% | 73.00% |
Risk-free interest rate | 1.00% | 0.40% |
Expected dividend yield | 0.00% | 0.00% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Shares | ||
Expired (in shares) | (54,052) | |
Weighted Average Exercise Price | ||
Weighted average exercise price, expired (in usd per share) | $ 23.01 | |
Outstanding options | ||
Shares | ||
Options outstanding (in shares) | 4,688,625 | |
Granted (in shares) | 2,645,000 | |
Exercised (in shares) | 0 | |
Forfeited (in shares) | (219,731) | |
Options outstanding (in shares) | 7,059,842 | 4,688,625 |
Options vested and exercisable (in shares) | 2,013,110 | |
Options outstanding and expected to vest (in shares) | 4,291,193 | |
Weighted Average Exercise Price | ||
Weighted average exercise price (in usd per share) | $ 4.66 | |
Weighted average exercise price, granted (in usd per share) | 0.89 | |
Weighted average exercise price, exercised (in usd per share) | 0 | |
Weighted average exercise price, forfeited (in usd per share) | 1.57 | |
Weighted average exercise price (in usd per share) | 3.20 | $ 4.66 |
Options vested and exercisable (in usd per share) | 8.13 | |
Options outstanding and expected to vest (in usd per share) | $ 1.27 | |
Total Intrinsic Value | ||
Intrinsic value, outstanding | $ 0 | $ 0 |
Intrinsic value, options vested and exercisable | 0 | |
Options outstanding and expected to vest | $ 0 | |
Weighted Average Remaining Contractual Life (In Years) | ||
Weighted average remaining contractual life (in years), outstanding | 8 years 6 months 10 days | 9 years 14 days |
Weighted average remaining contractual life (in years), Options vested and exercisable | 7 years 3 months 3 days | |
Weighted average remaining contractual life (in years), options outstanding and expected to vest | 9 years 7 days |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock unit Activity (Details) - Unvested restricted stock units | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Shares | |
Unvested at beginning of period (in shares) | shares | 143,000 |
Granted (in shares) | shares | 47,435 |
Vested (in shares) | shares | (189,435) |
Forfeited (in shares) | shares | (1,000) |
Unvested at End of period (in shares) | shares | 0 |
Weighted Average Grant Date Fair Value | |
Unvested at beginning of period (in usd per share) | $ / shares | $ 1.38 |
Granted (in usd per share) | $ / shares | 0.78 |
Vested (in usd per share) | $ / shares | 1.23 |
Forfeited (in usd per share) | $ / shares | 1.38 |
Unvested at end of period (in usd per share) | $ / shares | $ 0 |
STOCK-BASED COMPENSATION - Shar
STOCK-BASED COMPENSATION - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 2,263 | $ 1,993 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 478 | 392 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,785 | $ 1,601 |
INCOME TAXES - Effective Income
INCOME TAXES - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
State taxes, net of federal benefit | 4.93% | 3.80% |
Research and development tax credits | 2.22% | 0.11% |
Permanent differences and other | 1.29% | 0.18% |
Stock-based compensation | (0.36%) | (1.35%) |
Change in tax rate | 0.00% | (0.32%) |
Change in deferred tax asset valuation allowance | (29.08%) | (23.42%) |
Effective income tax rate | 0.00% | 0.00% |
INCOME TAXES - Summary of Defer
INCOME TAXES - Summary of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | ||
NOL carryforwards | $ 100,831 | $ 90,035 |
Research and development and other tax credits | 16,881 | 15,566 |
Depreciable assets | 6,481 | 8,356 |
Accrued expenses | 95 | 818 |
Intangible assets | 1,470 | 361 |
Stock-based compensation | 1,238 | 373 |
Other | 15 | 22 |
Net deferred tax asset | 127,011 | 115,531 |
Less: valuation allowance | (127,011) | (115,531) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | ||||
Net deferred tax asset | $ 127,011 | $ 115,531 | ||
Research and development and other tax credits | 16,881 | 15,566 | ||
Increase in deferred tax asset valuation allowance | (11,500) | 4,900 | ||
Unrecognized tax benefits | 21,700 | 21,700 | ||
Federal Tax Authority | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 455,905 | 420,800 | $ 321,500 | $ 134,400 |
State and Local Jurisdiction | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 429,028 | 382,700 | ||
Federal research and development credits and orphan drug credit | Federal Tax Authority | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | $ 26,600 | $ 27,700 |
INCOME TAXES - Summary of Feder
INCOME TAXES - Summary of Federal and State Carryforwards and Credits Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 |
Federal NOLs | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 455,905 | $ 420,800 | $ 321,500 | $ 134,400 |
Federal NOLs | 2022 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 22,420 | |||
Federal NOLs | 2023 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 22,398 | |||
Federal NOLs | 2024 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 25,032 | |||
Federal NOLs | 2025 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 27,190 | |||
Federal NOLs | 2026 and thereafter | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 224,441 | |||
Federal NOLs | Indefinite | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 134,424 | |||
State NOLs | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 429,028 | $ 382,700 | ||
State NOLs | 2022 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 0 | |||
State NOLs | 2023 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 0 | |||
State NOLs | 2024 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 0 | |||
State NOLs | 2025 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 0 | |||
State NOLs | 2026 and thereafter | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 389,944 | |||
State NOLs | Indefinite | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 39,084 | |||
Federal R&D Credit | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 9,540 | |||
Federal R&D Credit | 2022 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 483 | |||
Federal R&D Credit | 2023 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 322 | |||
Federal R&D Credit | 2024 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 213 | |||
Federal R&D Credit | 2025 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 456 | |||
Federal R&D Credit | 2026 and thereafter | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 8,066 | |||
Federal R&D Credit | Indefinite | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 0 | |||
Federal Orphan Drug Credit | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 17,015 | |||
Federal Orphan Drug Credit | 2022 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 1,610 | |||
Federal Orphan Drug Credit | 2023 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 929 | |||
Federal Orphan Drug Credit | 2024 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 663 | |||
Federal Orphan Drug Credit | 2025 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 507 | |||
Federal Orphan Drug Credit | 2026 and thereafter | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 13,306 | |||
Federal Orphan Drug Credit | Indefinite | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 0 | |||
State R&D Credit | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 9,572 | |||
State R&D Credit | 2022 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 0 | |||
State R&D Credit | 2023 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 0 | |||
State R&D Credit | 2024 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 0 | |||
State R&D Credit | 2025 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 0 | |||
State R&D Credit | 2026 and thereafter | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | 0 | |||
State R&D Credit | Indefinite | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforwards | $ 9,572 |