COVER PAGE
COVER PAGE - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 05, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Period End Date | Dec. 31, 2020 | ||
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 | $ 26.6 | ||
Entity Common Stock, Shares Outstanding | 66,929,896 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement relating to its 2021 annual meeting of shareholders (the “2021 Proxy Statement”) are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The 2021 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 | 2020 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 30,115 | $ 7,232 |
Marketable securities, available-for-sale | 0 | 4,497 |
Prepaid expenses and other current assets | 3,415 | 6,240 |
Total current assets | 33,530 | 17,969 |
Property and equipment, net | 30 | 16 |
Operating lease right-of-use asset | 74 | 159 |
Total assets | 33,634 | 18,144 |
Current liabilities: | ||
Accounts payable | 568 | 2,245 |
Accrued liabilities | 5,420 | 6,379 |
Lease liability, current portion | 74 | 78 |
Deferred revenue | 0 | 1,795 |
Note payable, current portion | 291 | 0 |
Total current liabilities | 6,353 | 10,497 |
Lease liability, net of current portion | 0 | 73 |
Note payable, net of current portion | 146 | 0 |
Total liabilities | 6,499 | 10,570 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Common stock, $0.01 par value, 100,000,000 and 50,000,000 shares authorized at December 31, 2020 and 2019, respectively; 53,551,461 and 8,480,968 shares issued and outstanding at December 31, 2020 and 2019, respectively | 536 | 85 |
Additional paid-in capital | 132,492 | 92,497 |
Accumulated other comprehensive loss | 0 | (28) |
Accumulated deficit | (105,893) | (84,980) |
Total stockholders’ equity | 27,135 | 7,574 |
Total liabilities and stockholders’ equity | $ 33,634 | $ 18,144 |
CONSOLIDATED BALANCE SHEETS (PA
CONSOLIDATED BALANCE SHEETS (PARENTHETICAL) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 100,000,000 | 50,000,000 |
Common stock, shares issued (in shares) | 53,551,461 | 8,480,968 |
Common stock, shares outstanding (in shares) | 53,551,461 | 8,480,968 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Total revenue | $ 1,822 | $ 7,917 |
Operating expenses: | ||
Research and development | 11,216 | 20,214 |
General and administrative | 11,582 | 12,171 |
Total operating expenses | 22,798 | 32,385 |
Loss from operations | (20,976) | (24,468) |
Investment and other income, net | 63 | 157 |
Gain on extinguishment | 0 | 2,318 |
Interest expense | 0 | (2,096) |
Change in fair value of warrant and derivative liability | 0 | 212 |
Net loss | (20,913) | (23,877) |
Reduction of redeemable convertible preferred stock to redemption value | 0 | 10,274 |
Net loss attributable to common stockholders | $ (20,913) | $ (13,603) |
Net loss per common share attributable to common stockholders, basic and diluted (in usd per share) | $ (0.85) | $ (4.50) |
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted (in shares) | 24,514,157 | 3,023,023 |
Collaboration revenue | ||
Total revenue | $ 1,795 | $ 7,917 |
Royalty revenue | ||
Total revenue | $ 27 | $ 0 |
CONSOLIDATED STATMENTS OF COMPR
CONSOLIDATED STATMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (20,913) | $ (23,877) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on available-for-sale marketable securities arising during holding period, net of tax benefit of $0 | 28 | (28) |
Total comprehensive loss | $ (20,885) | $ (23,905) |
CONSOLIDATED STATMENTS OF COM_2
CONSOLIDATED STATMENTS OF COMPREHENSIVE LOSS (PARENTHETICAL) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | ||
Unrealized loss arising during holding period, tax benefit (expense) | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF REDE
CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Redeemable Convertible Preferred Stock And Preferred Stock Dividends To Common Stock | Convertible Notes Payable And Accrued Interest To Common Stock | Series A, B, C & C-1 Redeemable Convertible Preferred Stock | Series A, B, C & C-1 Redeemable Convertible Preferred StockRedeemable Convertible Preferred Stock And Preferred Stock Dividends To Common Stock | Common Stock | Common StockRedeemable Convertible Preferred Stock And Preferred Stock Dividends To Common Stock | Common StockConvertible Notes Payable And Accrued Interest To Common Stock | Additional Paid-In Capital | Additional Paid-In CapitalRedeemable Convertible Preferred Stock And Preferred Stock Dividends To Common Stock | Additional Paid-In CapitalConvertible Notes Payable And Accrued Interest To Common Stock | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2018 | 1,256,466 | ||||||||||||
Beginning Balance at Dec. 31, 2018 | $ 58,290 | ||||||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||||||
Reduction of redeemable convertible preferred stock to redemption value | $ (10,274) | ||||||||||||
Conversion of redeemable convertible preferred stock and preferred stock dividends to common stock (in shares) | (1,256,466) | ||||||||||||
Conversion of redeemable convertible preferred stock and preferred stock dividends to common stock | $ (48,016) | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2019 | 0 | ||||||||||||
Ending Balance at Dec. 31, 2019 | $ 0 | ||||||||||||
Beginning Balance (in shares) at Dec. 31, 2018 | 589,001 | ||||||||||||
Beginning Balance at Dec. 31, 2018 | $ (71,618) | $ 6 | $ 0 | $ 0 | $ (71,624) | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Reduction of redeemable convertible preferred stock to redemption value | 10,274 | (247) | 10,521 | ||||||||||
Common stock issued, net of issuance costs (in shares) | 2,783,951 | 1,069,740 | |||||||||||
Common stock issued, net of issuance costs | $ 48,016 | $ 5,092 | $ 28 | $ 10 | $ 47,988 | $ 5,082 | |||||||
Common stock issued in recapitalization (in shares) | 3,367,988 | ||||||||||||
Common stock issued in recapitalization | 36,093 | $ 34 | 36,059 | ||||||||||
Reclassification of warrant liability to equity | 1,511 | 1,511 | |||||||||||
Issuance of common stock upon exercise of warrants (in shares) | 670,288 | ||||||||||||
Issuance of common stock upon exercise of warrants | 47 | $ 7 | 40 | ||||||||||
Common stock warrants issued in connection with the research and development funding liability | 532 | 532 | |||||||||||
Stock based compensation | 1,532 | 1,532 | |||||||||||
Unrealized loss on available-for-sale marketable securities | (28) | (28) | |||||||||||
Net income (loss) | $ (23,877) | (23,877) | |||||||||||
Ending Balance (in shares) at Dec. 31, 2019 | 8,480,968 | 8,480,968 | |||||||||||
Ending Balance at Dec. 31, 2019 | $ 7,574 | $ 85 | 92,497 | (28) | (84,980) | ||||||||
Ending Balance (in shares) at Dec. 31, 2020 | 0 | ||||||||||||
Ending Balance at Dec. 31, 2020 | $ 0 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Common stock issued, net of issuance costs (in shares) | 39,103,810 | ||||||||||||
Common stock issued, 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 | (50) | $ 1 | (51) | ||||||||||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes (in shares) | 118,522 | ||||||||||||
Stock based compensation | 1,993 | 1,993 | |||||||||||
Unrealized loss on available-for-sale marketable securities | 28 | 28 | |||||||||||
Net income (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) |
CONSOLIDATED STATEMENTS OF RE_2
CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) - Parenthetical $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance of common stock and common stock purchase warrants, issuance costs | $ 2,840 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (20,913) | $ (23,877) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,993 | 1,532 |
Issuance of common stock under license agreement | 500 | 0 |
Depreciation | 10 | 28 |
Reduction (accretion) of discount on marketable securities | 25 | (41) |
Non-cash interest expense | 0 | 666 |
Impairment expense | 0 | 441 |
Change in fair value of contingent consideration | 0 | (145) |
Change in fair value of warrant and derivative liability | 0 | (212) |
Gain on extinguishment | 0 | (2,318) |
Amortization of discounts and financing costs | 0 | 1,575 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 2,833 | (4,562) |
Accounts payable | (1,677) | (1,822) |
Accrued liabilities | (1,010) | 671 |
Deferred revenue | (1,795) | (7,917) |
Net cash used in operating activities | (20,034) | (35,981) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Maturities of marketable securities | 4,500 | 19,500 |
Capital expenditures | (23) | (7) |
Cash and cash equivalents acquired in recapitalization | 0 | 13,017 |
Net cash provided by investing activities | 4,477 | 32,510 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of common stock and warrants | 37,977 | 0 |
Proceeds from the issuance of note payable | 437 | 0 |
Proceeds from the exercise of warrants | 26 | 47 |
Proceeds from issuance of convertible promissory notes | 0 | 7,397 |
Payments of principal of note payable | 0 | (4,808) |
Net cash provided by financing activities | 38,440 | 2,636 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 22,883 | (835) |
CASH AND CASH EQUIVALENTS—BEGINNING | 7,232 | 8,067 |
CASH AND CASH EQUIVALENTS—ENDING | 30,115 | 7,232 |
Supplement Disclosure of Cash Flow Information: | ||
Interest paid | 0 | 432 |
Supplement Disclosure of Non-Cash Investing and Financing Activities: | ||
Conversion of redeemable convertible preferred stock and preferred stock dividends to common stock | 0 | 48,016 |
Shares issued in recapitalization | 0 | 23,076 |
Reduction of redeemable convertible preferred stock to redemption value | 0 | (10,376) |
Warrants to purchase common stock issued with convertible promissory notes | 0 | 8,063 |
Warrants to purchase common stock issued with convertible promissory notes | 0 | 1,492 |
Derivative liability issued with convertible promissory notes | 0 | 1,442 |
Warrants to purchase common stock issued with funding agreement | 0 | 876 |
Accretion of redeemable convertible preferred stock issuance costs | $ 0 | $ 103 |
ORGANIZATION AND NATURE OF OPER
ORGANIZATION AND NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2020 | |
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 focused on the development of innovative and differentiated prescription therapeutics for debilitating skin diseases with a focus on our lead asset for the treatment of hyperhidrosis. The Company’s pivotal Phase 3 clinical-stage investigational product candidate, sofpironium bromide, is a new chemical entity that belongs to a class of medications called anticholinergics. The Company intends to develop sofpironium bromide as a potential best-in-class, self-administered, once daily, topical therapy for the treatment of primary axillary hyperhidrosis. The Company’s operations to date have been limited to business planning, raising capital, developing its pipeline assets (in particular sofpironium bromide), identifying product candidates, conducting clinical trials, and other research and development. On August 31, 2019, the Company, then known as Vical Incorporated (“Vical”), and Brickell Biotech, Inc., a then privately-held Delaware corporation that began activities in September 2009 (“Private Brickell”), completed a recapitalization in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated June 2, 2019, as further amended on August 20, 2019 and on August 30, 2019 (the “Merger Agreement”), by and among Vical, Victory Subsidiary, Inc., a wholly-owned subsidiary of Vical (“Merger Sub”), and Private Brickell. Pursuant to the Merger Agreement, Merger Sub merged with and into Private Brickell, with Private Brickell surviving as a wholly-owned subsidiary of Vical (the “Merger”). Additionally, on August 31, 2019, immediately after the completion of the Merger, the Company changed its name from “Vical Incorporated” to “Brickell Biotech, Inc.” and Private Brickell changed its name from “Brickell Biotech, Inc.” to “Brickell Subsidiary, Inc.” The accompanying consolidated financial statements and related notes reflect the historical results of Private Brickell prior to the Merger and of the combined company following the Merger, and do not include the historical results of Vical prior to the completion of the Merger. Liquidity and Capital Resources The Company has incurred significant operating losses and has an accumulated deficit as a result of ongoing efforts to develop product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. For the year ended December 31, 2020, the Company had a net loss of $20.9 million and net cash used in operating activities of $20.0 million. As of December 31, 2020, the Company had cash and cash equivalents of $30.1 million and an accumulated deficit of $105.9 million. The Company believes that its cash and cash equivalents as of December 31, 2020, along with the cash proceeds received subsequent to December 31, 2020 as disclosed in Note 10. Subsequent Events , are sufficient to fund its operations for at least the next 12 months from the issuance of these consolidated financial statements. The Company expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. Additional funding will be required in the future to continue with the Company’s planned development and commercial related activities. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
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 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 balances in several accounts with two financial institutions 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 approximately $10 thousand and $28 thousand for the years ended December 31, 2020 and 2019, 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 is established to distinguish 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), and establishes a classification of fair value measurements for disclosure purposes. 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, 2020 2019 Assets: Money market funds $ 29,182 $ 7,232 U.S. treasuries — 4,497 Total $ 29,182 $ 11,729 ____________ (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). U.S. Treasuries— The Company designated its investments in U.S. treasury securities as available-for-sale securities and accounted for them at their respective fair values. The securities were classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Securities that were readily available for use in current operations are classified as short-term available-for-sale marketable securities and are reported as a component of current assets in the consolidated balance sheets (Level 1 of the fair value hierarchy). Securities classified as available-for-sale are measured at fair value, including accrued interest, with temporary unrealized gains and losses reported as a component of stockholders’ equity until their disposition. The Company reviews available-for-sale securities at the end of each period to determine whether they remain available-for-sale based on its then-current intent. The cost of securities sold is based on the specific identification method. The securities are subject to a periodic impairment review. An impairment charge would occur when a decline in the fair value of the investments below the cost basis is judged to be other-than-temporary. Leases The Company accounts for leases under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 842, Leases (“ASC 842”). Under ASC 842, the Company determines if an arrangement is a lease at inception. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected 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. 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 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. To determine revenue recognition for contracts with customers, 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; (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. To date, the Company has not received approval for any drug candidates from the FDA. In March 2015, the Company entered into a license, development, and commercialization agreement (as amended, the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”). Under the Kaken Agreement, the Company granted to Kaken an exclusive right to develop, manufacture, and commercialize the Company’s sofpironium bromide compound, a topical anticholinergic, in Japan and certain other Asian countries (the “Territory”). In exchange, Kaken paid the Company an upfront, non-refundable payment of $11.0 million (the “upfront fee”). 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. The Company evaluates collaboration arrangements to determine whether units of account within the collaboration arrangement exhibit the characteristics of a vendor and customer relationship. The Company determined that the licenses transferred to Kaken in exchange for the upfront fee were representative of this type of relationship. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition on a prospective basis. Under Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), the Company evaluated the terms of the Kaken Agreement, and the transfer of intellectual property and manufacturing rights (the “license”) was identified as the only performance obligation as of the inception of the agreement. The Company concluded that the license for the intellectual property was distinct from its ongoing supply obligations. The Company further determined that the transaction price under the arrangement was comprised of the $11.0 million upfront payment, which was allocated to the license performance obligation. The future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained. As part of its evaluation of the development and regulatory milestones constraint, the Company determined that the achievement of such milestones was contingent upon success in future clinical trials and regulatory approvals, each of which was uncertain at that time. The Company re-evaluates the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur. Future potential milestone amounts would be recognized as revenue from collaboration arrangements, if and when they become unconstrained. The remainder of the arrangement, which largely consisted of both parties incurring costs in their respective territories, provides for the reimbursement of the ongoing supply costs. These costs were representative of a collaboration arrangement outside of the scope of Topic 606 as they do not have the characteristics of a vendor and customer relationship. Reimbursable program costs are recognized proportionately with the delivery of drug substance and are accounted for as reductions to research and development expense and are excluded from the transaction price. 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. These clinical trials have a benefit to Kaken and have the characteristics of a vendor and customer relationship. The Company has accounted for the Kaken R&D Payment under the provisions of Topic 606. This Kaken R&D Payment is recognized using an input method in proportion to the cost incurred. 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 150 basis points. During the years ended December 31, 2020 and 2019, the Company recognized revenue of $1.8 million and $7.9 million, respectively, related to the Kaken R&D Payment. As of December 31, 2019, the Company had a deferred revenue balance related to the Kaken R&D Payment of $1.8 million, which is recorded as deferred revenue on the accompanying consolidated balance sheet. As of December 31, 2020, there was no remaining deferred revenue balance related to the Kaken R&D Payment. 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 associated milestone value 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, or other revenues and earnings in the period of adjustment. To date, Kaken has paid the Company $10.0 million in milestone payments under the Kaken Agreement. 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). Prior to 2020, the Company had not recognized any royalty revenue from any collaboration arrangement. In September 2020, Kaken received regulatory approval in Japan to manufacture and market sofpironium bromide gel, 5% for the treatment of primary axillary (underarm) hyperhidrosis. During the year ended December 31, 2020, the Company recognized royalty revenue earned on a percentage of net sales of sofpironium bromide in Japan of approximately $27 thousand. 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, clinical studies, clinical manufacturing costs, salaries and employee benefits, toxicology studies, 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. 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. Net Income (Loss) per Common Share Basic and diluted net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders 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 (loss) attributable to common stockholders by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares. Diluted earnings per share gives effect to all dilutive potential common shares outstanding during the period, including stock options, restricted stock units, and warrants, using the treasury stock method, and redeemable convertible preferred stock and convertible promissory notes, using the if-converted method. In computing diluted earnings per share, the average stock price for the period is used in determining the number of shares assumed to be issued from the exercise of stock options, the vesting of restricted stock units, or the exercise of warrants. Potentially dilutive common share equivalents are excluded from the diluted earnings per share computation in net loss periods because their effect would be anti-dilutive. The following table sets forth the potential common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive: Year Ended 2020 2019 Outstanding warrants 40,389,431 720,982 Outstanding options 4,688,625 525,665 Unvested restricted stock units 143,000 — Total 45,221,056 1,246,647 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 carryforwards, tax credits, accruals and reserves, and capitalized start-up costs. 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, 2020 and 2019 . 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 identifying, developing, and commercializing innovative and differentiated therapeutics for the treatment of skin 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 FASB 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 have or may have a material impact on the Company's consolidated financial statements or disclosures. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
ACCRUED LIABILITIES | ACCRUED LIABILITIES Accrued liabilities consisted of the following (in thousands): December 31, 2020 2019 Accrued contracted research and development services $ 3,733 $ 4,532 Accrued compensation 1,369 59 Accrued professional fees 318 1,788 Total $ 5,420 $ 6,379 |
CONVERTIBLE PROMISSORY NOTES
CONVERTIBLE PROMISSORY NOTES | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE PROMISSORY NOTES | CONVERTIBLE PROMISSORY NOTES In March 2019, the Company initiated a convertible promissory notes offering pursuant to which the Company issued unsecured convertible promissory notes (the “Prom Notes”), bearing interest at 12.0% with a maturity of one year. Through August 31, 2019, the Company had raised an aggregate principal amount of $7.4 million in Prom Notes, including $1.7 million from certain of the Company’s management and board of directors. On August 31, 2019, immediately prior to the Merger, the Prom Notes and related accrued interest converted into 1,069,740 shares of Private Brickell common stock at a conversion price of $7.54 per share. The Prom Notes also provided for the issuance of warrants at 50% coverage, to acquire 490,683 shares of common stock. The warrants are exercisable for a term of five years at an exercise price of $10.36. The Company evaluated the various financial instruments under ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “Derivatives and Hedging” (“ASC 815”), and determined the warrants required fair value accounting. The fair value of the warrants was recorded as a warrant liability upon issuance. The fair value of the warrants on the dates of issuance of $1.5 million was determined with the assistance of a third-party valuation firm. The fair value of the warrants was recorded as a debt discount upon issuance and was amortized to interest expense over the term of the Prom Notes based on the effective interest method. At inception of the Prom Notes offering, the Company analyzed the conversion feature of the agreement for derivative accounting consideration under ASC 815 and determined that the embedded conversion features should be classified as a derivative, which was required to be bifurcated and recorded as a derivative liability. The embedded derivative for the Prom Notes was carried on the Company’s consolidated balance sheets at fair value. The derivative liability was marked-to-market each measurement period and any change in fair value was recorded as a component of the statements of operations. The fair value of the derivative liabilities on the date of issuance of $1.4 million was determined with the assistance of a third-party valuation firm. The fair value of the conversion feature was recorded as a debt discount upon issuance and was amortized to interest expense over the term of the Prom Notes based on the effective interest method. During the year ended December 31, 2019, the Company recognized $2.0 million of interest expense, including $0.8 million of accretion of discounts using an effective interest rate of 12.0%. As a result of the conversion on August 31, 2019, the Prom Notes payable, warrant liability, and derivative liability balances were reclassified to equity in the consolidated balance sheets. A gain of $2.3 million resulted from the conversion of the Prom Notes, which was included in a gain on |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
NOTE PAYABLE | NOTE PAYABLE Loan Agreement with Hercules Capital, Inc. On February 18, 2016, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (the “Lender”) under which the Company borrowed $7.5 million upon the execution of the Loan Agreement on February 18, 2016. The interest rate applicable to each tranche was variable based upon the greater of either (i) 9.2% and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal minus 3.5%, plus (b) 9.2%. Payments under the Loan Agreement were interest only until June 1, 2017, followed by equal monthly payments of principal and interest through the maturity date of September 1, 2019. The Company paid the Lender aggregate facility fees of $0.2 million in connection with the Loan Agreement. In connection with the Loan Agreement, the Company issued warrants to the Lender, which are exercisable for 9,005 shares of common stock at a per share exercise price of $33.31 (the “Hercules Capital Warrants”). The Hercules Capital Warrants will terminate, if not earlier exercised, on February 18, 2026. The fair value of the Hercules Capital Warrants was recorded at inception as a redeemable convertible preferred stock warrant liability upon issuance. On September 3, 2019, the Company repaid the remaining outstanding loan balance of $2.6 million and an associated accrued interest and aggregate end-of-term payment of $0.6 million, and the Loan Agreement was terminated. At the effective time of the Merger, the warrant liability was reclassified to equity in the consolidated balance sheets. As of December 31, 2020, there were no remaining unaccreted debt discounts and issuance costs. Paycheck Protection Program 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”) , which is reported in the consolidated balance sheet as of December 31, 2020, within the current and long-term note payable line items. A PPP loan is for the purpose of helping businesses keep their workforce employed during the COVID-19 crisis. The Company used the PPP Loan proceeds to cover payroll costs and certain other permitted costs in accordance with the relevant terms and conditions of the CARES Act. The PPP Loan is in the principal amount of $0.4 million, bears interest at a fixed rate of 1.00% per annum, and matures on November 15, 2022. The PPP Loan requires equal monthly payments of principal and interest commencing on either (1) the date that Small Business Administration remits the Company’s loan forgiveness amount to IberiaBank or (2) 10 months after the end of the Company’s loan forgiveness covered period. The PPP Loan may be prepaid by the Company at any time prior to maturity without penalty. As of December 31, 2020, the Company evaluated the uses of proceeds under the PPP Loan with respect to the relevant terms and conditions of the CARES Act and believes that the full amount of the loan is subject to forgiveness. In January 2021, the Company applied for forgiveness of the full amount of the PPP Loan, which has not yet been granted. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Operating Leases In August 2016, the Company entered into a five-year lease for office space in Boulder, Colorado that expires on October 31, 2021 (the “Boulder Lease”) subject to the Company’s option to renew the Boulder Lease for two additional terms of three years each. Pursuant to the Boulder Lease, the Company leased 3,038 square feet of space in a multi-suite building. Rent payments under the Boulder Lease included base rent of $4,430 per month during the first year of the Boulder Lease with an annual increase of 3.5%, and additional monthly fees to cover the Company’s share of certain facility expenses, including utilities, property taxes, insurance, and maintenance, which were $2,160 per month during the first year of the Boulder Lease. The Company recognized a right-of-use asset and corresponding lease liability on January 1, 2019 by calculating the present value of lease payments, discounted at the Company’s estimated incremental borrowing rate of 12.0%, over the 2.8 years expected remaining term. As the Company’s lease does not provide an implicit rate, the Company estimated the incremental borrowing rate based on industry peers. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics, including the progress of clinical trials and therapeutic indications. Amortization of the operating lease right-of-use asset for the Boulder Lease amounted to $0.1 million for the year ended December 31, 2020, which was included in operating expense. The terms of the Boulder Lease provide for monthly rental payments on a graduated scale. Lease expense for each of the years ended December 31, 2020 and 2019 was $0.1 million. The following is a summary of the contractual obligations related to operating lease commitments as of December 31, 2020, and the effect such obligations are expected to have on the Company’s liquidity and cash flows in future periods (in thousands): Less than 1 year $ 78 Imputed interest (4) Total $ 74 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”). The Amended and Restated License Agreement 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. In exchange for entering into the Amended and Restated License Agreement, settling the previously disclosed dispute, and resolving the associated litigation between the Company and Bodor, the Company made an upfront payment of $1.0 million in cash to Bodor following the execution of the Amended and Restated License Agreement and the settlement agreement by and among the Company, Brickell Subsidiary, and Bodor, dated February 17, 2020. Additionally, under the original License Agreement and the Amended and Restated License Agreement, the Company is required to pay Bodor (i) a royalty on sales of product outside Kaken’s territory, including a low single-digit royalty on sales of certain product not covered by the patent estate licensed from Bodor; (ii) a specified percentage of all royalties the Company receives from Kaken for sales of product within its territory; (iii) a percentage of non-royalty sublicensing income the Company receives from Kaken or other sublicensees; and (iv) up to an aggregate of $1.8 million (plus an additional $0.1 million for approvals of additional products) in cash payments and $1.5 million of shares of the Company’s common stock upon the achievement of certain development, regulatory and other milestones, including the enrollment of the first patient in the U.S. Phase 3 trials. Based on the foregoing, the Company made a $0.5 million milestone payment to Bodor in June 2020 following the closing of the June 2020 Offering (see Note 7. “Capital Stock”). Additionally, in October 2020, in association with the enrollment of the first patient in its U.S. Phase 3 pivotal program, the Company made a cash payment of $0.5 million and issued $0.5 million, or 480,769 shares, of the Company’s common stock to Bodor. As a result, during the year ended December 31, 2020, the Company recorded an aggregate of $1.5 million as research and development expense in the consolidated statements of operations. |
CAPITAL STOCK
CAPITAL STOCK | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
CAPITAL STOCK | CAPITAL STOCK Common Stock Under the Company’s amended and restated certificate of incorporation, the Company is authorized to issue 100,000,000 shares of common stock with a par value of $0.01 per share. 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 has reserved authorized shares of common stock for future issuance at December 31, 2020 as follows: December 31, Common stock warrants 40,389,431 Common stock options outstanding 4,688,625 Shares available for grant under the Omnibus Plan 2,062,535 Unvested restricted stock units 143,000 Total 47,283,591 The Company will be significantly limited in its ability to sell shares of its common stock under the Purchase Agreement or ATM Agreement described below unless and until the number of authorized shares of common stock of the Company is increased, which would require stockholder approval. Public Offerings of Common Stock and Warrants 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. 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”) (and together with the October 2020 Offering, the “2020 Offerings”). 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. The Company is using the net proceeds from the 2020 Offerings for research and development, including clinical trials, working capital, and general corporate purposes. At Market Issuance Sales Agreement In April 2020, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with Oppenheimer & Co. Inc. (“Oppenheimer”) as the Company’s sales agent (the “Agent”). Pursuant to the terms of the ATM Agreement, the Company may sell from time to time through the Agent shares of its common stock having an aggregate offering price of up to $8.0 million (the “Shares”). The 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 the Agent. Under the terms of the ATM Agreement, the Company may also sell the Shares from time to time to the 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 the Agent as principal would be pursuant to the terms of a separate placement notice between the Company and the Agent. During the year ended December 31, 2020, the Company sold 4,360,167 Shares under the ATM Agreement at a weighted-average price of $0.85 per share, for aggregate net proceeds of $3.4 million, after giving effect to a 3% commission to Oppenheimer as Agent plus initial expenses for executing the 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. Sales of common stock by the Company, if any, 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. As of December 31, 2020, the Company has not made any sales of its common stock 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, 2020 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION Equity Incentive Plans 2020 Omnibus Plan 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 additional grants will be made pursuant to the Prior Plans, but awards outstanding under those plans as of that date remain outstanding in accordance with their terms. On August 31, 2020, the Company’s stockholders approved an increase in the number of shares of common stock authorized for issuance under the Omnibus Plan by 4,500,000. As of December 31, 2020, 5,125,000 shares were authorized under the Omnibus Plan and 3,295,832 shares were subject to outstanding awards under the Omnibus Plan. As of December 31, 2020, 2,062,535 shares remained available for grant under the Omnibus Plan, subject to limitations as a result of the limited number of available shares due to the Company’s number of authorized shares of common stock at that date. 2009 Equity Incentive Plan The 2009 Plan was replaced by the Omnibus Plan on April 20, 2020, and as a result, as of December 31, 2020, there were no remaining shares available for new grants under the 2009 Plan. However, as of December 31, 2020, 1,282,381 shares were subject to outstanding awards under the 2009 Plan, which awards remain outstanding in accordance with their terms. Vical Equity Incentive Plan In connection with the Merger, the Company adopted the Vical Plan, which was replaced by the Omnibus Plan on April 20, 2020. As a result, as of December 31, 2020, there were no remaining shares available for new grants under the Vical Plan. However, as of December 31, 2020, 253,412 shares were subject to outstanding awards under the Vical Plan, which awards remain outstanding in accordance with their terms. Fair Value Assumptions The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock-based awards. 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 During the year ended December 31, 2020, the Company granted 3,309,334 stock options to purchase shares of the Company’s common stock with a weighted-average grant date fair value of $0.52 per share and a weighted-average exercise price of $0.80 per share. During the year ended December 31, 2019, the Company granted 1,088,260 stock options with a weighted-average grant date fair value of $3.30 per share and a weighted-average exercise price of $4.67 per share. The assumptions used to calculate the fair value of stock options granted are as follows, presented on a weighted-average basis: Year Ended 2020 2019 Expected term 6.0 years 6.1 years Expected volatility 73.0% 83.2% Risk-free interest rate 0.4% 1.4% Expected dividend yield —% —% A summary of stock option activity under the Company’s incentive plans is as follows: Shares Weighted Total Intrinsic Weighted Average Outstanding as of December 31, 2019 1,793,602 $ 13.00 $ 4,971 8.49 Granted 3,309,334 $ 0.80 Forfeited or expired (414,311) $ 9.98 Outstanding as of December 31, 2020 4,688,625 $ 4.66 $ — 9.04 Options vested and exercisable as of December 31, 2020 809,309 $ 18.37 $ — 6.75 As of December 31, 2020, the Company had $4.7 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 2.7 years. Restricted Stock Units Restricted stock unit (“RSU”) activity during the year ended December 31, 2020 is shown below. There was no RSU-related activity during the year ended December 31, 2019. Shares Weighted Average Grant Date Fair Value Unvested as of December 31, 2019 — $ — Granted 360,205 $ 1.21 Vested and settled (170,037) $ 1.04 Forfeited (47,168) $ 1.35 Unvested as of December 31, 2020 143,000 $ 1.38 The total grant date fair value and the total vest date fair value of RSUs vested during the year ended December 31, 2020 were both $0.2 million. As of December 31, 2020, unrecognized share-based compensation expense related to service-condition RSU awards was $0.1 million, which is expected to be recognized over a weighted-average period of 0.2 years. Stock-based Compensation Expense Total stock-based compensation expense reported in the consolidated statements of operations was allocated as follows (in thousands): Year Ended 2020 2019 Research and development $ 392 $ 349 General and administrative 1,601 1,183 Total stock-based compensation expense $ 1,993 $ 1,532 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES During the years ended December 31, 2020 and 2019, the Company recorded no income tax benefits for the net operating loss (“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 2020 2019 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 3.80 3.16 Research and development tax credits 0.11 3.25 Permanent differences and other 0.18 (2.51) Transaction costs — (1.88) Stock-based compensation (1.35) (1.02) Change in tax rate (0.32) 0.02 Change in deferred tax asset valuation allowance (23.42) (22.02) 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 2020 2019 Net operating loss carryforwards $ 90,035 $ 82,703 Research and development credit 15,566 15,509 Depreciable assets 8,356 10,443 Accrued expenses 818 719 Deferred revenue — 449 Intangible assets 361 415 Stock-based compensation 373 332 Other 22 63 Net deferred tax asset 115,531 110,633 Less: valuation allowance (115,531) (110,633) Net deferred tax assets $ — $ — As of December 31, 2020, the Company had deferred tax assets of $115.5 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. In 2019, the Company increased its NOL carryforward by $332.9 million and its credit carryforward by $23.5 million through the Merger. Vical completed a Section 382 analysis through December 31, 2011 as a result of an ownership change on December 29, 2006, as defined in 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 net operating loss carryforwards and tax credits. The Company estimates that $76.9 million of Vical’s acquired NOL carryforwards were effectively eliminated under Section 382 for federal tax purposes. The Company also estimates $8.2 million of Vical’s acquired research and development credits and other tax credits were effectively eliminated under Section 383 for federal purposes. Vical did not conduct a Section 382 study for periods between December 31, 2011 and the date of the Merger. 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. There is a risk that additional changes in ownership could have occurred between those dates. It is further noted, the Company has not completed an IRC 382 and 383 analysis to determine if a change in ownership has occurred since the inception of the Company. 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, 2020 and 2019, the Company had available federal NOL carryforwards of approximately $420.8 million and $403.9 million, respectively. The NOL generated in 2020 of $29.1 million and 2019 of $25.1 million will carry forward indefinitely and be available to offset up to 80% of future taxable income each year. NOLs generated prior to 2019 will expire from 2020 through 2038. In addition, the Company had federal research and development credits and orphan drug credit carryforwards of $27.7 million and $30.3 million as of December 31, 2020 and 2019, respectively, to reduce future federal income taxes, if any. The Company also has available state NOL carryforwards of approximately $382.7 million and $350.8 million as of December 31, 2020 and 2019, respectively. In addition, through the Merger, the Company acquired Vical’s California research and development credits of approximately $9.3 million as of December 31, 2020 and 2019, to reduce future California income tax, if any. The California research and development credits do not expire. 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 2021 $ 7,479 $ — $ 334 $ 1,962 $ — 2022 22,420 — 483 1,610 — 2023 22,398 — 322 929 — 2024 25,032 — 213 663 — 2025 and thereafter 251,631 382,688 7,080 13,813 — Indefinite 91,838 — — — 9,310 Totals $ 420,798 $ 382,688 $ 8,432 $ 18,977 $ 9,310 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, 2020 and 2019. Management reevaluates the positive and negative evidence at each reporting period. The Company’s valuation allowance increased by approximately $4.9 million for the year ended December 31, 2020. For the year ended December 31, 2019, the valuation allowance increased by $95.4 million which includes a full valuation allowance against the acquired deferred tax assets from the Merger. 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. Before the Merger, the Company had no material unrecognized tax benefits and no adjustments to its financial positions. However, the Merger brought with it certain unrecognized tax benefits. As a result of the Merger, the Company acquired gross unrecognized tax benefits with a balance of $21.7 million as of December 31, 2020 and 2019, none of which would affect the effective tax rate. 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 balance sheets as of December 31, 2020 and 2019, and has not recognized interest and/or penalties in its statements of operations for the years ended December 31, 2020 and 2019. As of December 31, 2020, 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, 2017. 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. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS Subsequent to December 31, 2020, and through March 9, 2021, 12,294,887 common warrants associated with the 2020 Offerings were exercised at a weighted-average exercise price of $0.72 per share, resulting in aggregate proceeds of approximately $8.9 million. Subsequent to December 31, 2020, and through March 9, 2021, the Company sold 1,083,548 shares of common stock under the ATM Agreement at a weighted-average price of $1.55 per share, for aggregate net proceeds of $1.6 million. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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 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 balances in several accounts with two financial institutions 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 is established to distinguish 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 |
Leases | Leases The Company accounts for leases under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 842, Leases (“ASC 842”). Under ASC 842, the Company determines if an arrangement is a lease at inception. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected 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 |
Revenue Recognition | Revenue Recognition 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. To determine revenue recognition for contracts with customers, 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; (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. To date, the Company has not received approval for any drug candidates from the FDA. In March 2015, the Company entered into a license, development, and commercialization agreement (as amended, the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”). Under the Kaken Agreement, the Company granted to Kaken an exclusive right to develop, manufacture, and commercialize the Company’s sofpironium bromide compound, a topical anticholinergic, in Japan and certain other Asian countries (the “Territory”). In exchange, Kaken paid the Company an upfront, non-refundable payment of $11.0 million (the “upfront fee”). 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. The Company evaluates collaboration arrangements to determine whether units of account within the collaboration arrangement exhibit the characteristics of a vendor and customer relationship. The Company determined that the licenses transferred to Kaken in exchange for the upfront fee were representative of this type of relationship. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition on a prospective basis. Under Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), the Company evaluated the terms of the Kaken Agreement, and the transfer of intellectual property and manufacturing rights (the “license”) was identified as the only performance obligation as of the inception of the agreement. The Company concluded that the license for the intellectual property was distinct from its ongoing supply obligations. The Company further determined that the transaction price under the arrangement was comprised of the $11.0 million upfront payment, which was allocated to the license performance obligation. The future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained. As part of its evaluation of the development and regulatory milestones constraint, the Company determined that the achievement of such milestones was contingent upon success in future clinical trials and regulatory approvals, each of which was uncertain at that time. The Company re-evaluates the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur. Future potential milestone amounts would be recognized as revenue from collaboration arrangements, if and when they become unconstrained. The remainder of the arrangement, which largely consisted of both parties incurring costs in their respective territories, provides for the reimbursement of the ongoing supply costs. These costs were representative of a collaboration arrangement outside of the scope of Topic 606 as they do not have the characteristics of a vendor and customer relationship. Reimbursable program costs are recognized proportionately with the delivery of drug substance and are accounted for as reductions to research and development expense and are excluded from the transaction price. 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. These clinical trials have a benefit to Kaken and have the characteristics of a vendor and customer relationship. The Company has accounted for the Kaken R&D Payment under the provisions of Topic 606. This Kaken R&D Payment is recognized using an input method in proportion to the cost incurred. 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 150 basis points. During the years ended December 31, 2020 and 2019, the Company recognized revenue of $1.8 million and $7.9 million, respectively, related to the Kaken R&D Payment. As of December 31, 2019, the Company had a deferred revenue balance related to the Kaken R&D Payment of $1.8 million, which is recorded as deferred revenue on the accompanying consolidated balance sheet. As of December 31, 2020, there was no remaining deferred revenue balance related to the Kaken R&D Payment. 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 associated milestone value 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, or other revenues and earnings in the period of adjustment. To date, Kaken has paid the Company $10.0 million in milestone payments under the Kaken Agreement. 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). Prior to 2020, the Company had not recognized any royalty revenue from any collaboration arrangement. In September 2020, Kaken received regulatory approval in Japan to manufacture and market sofpironium bromide gel, 5% for the treatment of primary axillary (underarm) hyperhidrosis. During the year ended December 31, 2020, the Company recognized royalty revenue earned on a percentage of net sales of sofpironium bromide in Japan of approximately $27 thousand. |
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, clinical studies, clinical manufacturing costs, salaries and employee benefits, toxicology studies, 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. |
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. |
Net Income (Loss) per Common Share | Net Income (Loss) per Common Share Basic and diluted net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders 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 (loss) attributable to common stockholders by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares. Diluted earnings per share gives effect to all dilutive potential common shares outstanding during the period, including stock options, restricted stock units, and warrants, using the treasury stock method, and redeemable convertible preferred stock and convertible promissory notes, using the if-converted method. In computing diluted earnings per share, the average stock price for the period is used in determining the number of shares assumed to be issued from the exercise of stock options, the vesting of restricted stock units, or the exercise of warrants. Potentially dilutive common share equivalents are excluded from the diluted earnings per share computation in net loss periods because their effect would be anti-dilutive. |
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 carryforwards, tax credits, accruals and reserves, and capitalized start-up costs. 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, 2020 and 2019 . |
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 identifying, developing, and commercializing innovative and differentiated therapeutics for the treatment of skin 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 FASB 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 have or may 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, 2020 | |
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, 2020 2019 Assets: Money market funds $ 29,182 $ 7,232 U.S. treasuries — 4,497 Total $ 29,182 $ 11,729 ____________ (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 net loss per common share because their inclusion would be anti-dilutive: Year Ended 2020 2019 Outstanding warrants 40,389,431 720,982 Outstanding options 4,688,625 525,665 Unvested restricted stock units 143,000 — Total 45,221,056 1,246,647 |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2020 2019 Accrued contracted research and development services $ 3,733 $ 4,532 Accrued compensation 1,369 59 Accrued professional fees 318 1,788 Total $ 5,420 $ 6,379 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Contractual Obligations | The following is a summary of the contractual obligations related to operating lease commitments as of December 31, 2020, and the effect such obligations are expected to have on the Company’s liquidity and cash flows in future periods (in thousands): Less than 1 year $ 78 Imputed interest (4) Total $ 74 |
CAPITAL STOCK (Tables)
CAPITAL STOCK (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Reserved Authorized Shares of Common Stock | The Company has reserved authorized shares of common stock for future issuance at December 31, 2020 as follows: December 31, Common stock warrants 40,389,431 Common stock options outstanding 4,688,625 Shares available for grant under the Omnibus Plan 2,062,535 Unvested restricted stock units 143,000 Total 47,283,591 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 2020 2019 Expected term 6.0 years 6.1 years Expected volatility 73.0% 83.2% Risk-free interest rate 0.4% 1.4% 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 Intrinsic Weighted Average Outstanding as of December 31, 2019 1,793,602 $ 13.00 $ 4,971 8.49 Granted 3,309,334 $ 0.80 Forfeited or expired (414,311) $ 9.98 Outstanding as of December 31, 2020 4,688,625 $ 4.66 $ — 9.04 Options vested and exercisable as of December 31, 2020 809,309 $ 18.37 $ — 6.75 |
Share-based Compensation Arrangements by Share-based Payment Award | Restricted stock unit (“RSU”) activity during the year ended December 31, 2020 is shown below. There was no RSU-related activity during the year ended December 31, 2019. Shares Weighted Average Grant Date Fair Value Unvested as of December 31, 2019 — $ — Granted 360,205 $ 1.21 Vested and settled (170,037) $ 1.04 Forfeited (47,168) $ 1.35 Unvested as of December 31, 2020 143,000 $ 1.38 |
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 2020 2019 Research and development $ 392 $ 349 General and administrative 1,601 1,183 Total stock-based compensation expense $ 1,993 $ 1,532 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 2020 2019 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 3.80 3.16 Research and development tax credits 0.11 3.25 Permanent differences and other 0.18 (2.51) Transaction costs — (1.88) Stock-based compensation (1.35) (1.02) Change in tax rate (0.32) 0.02 Change in deferred tax asset valuation allowance (23.42) (22.02) 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 2020 2019 Net operating loss carryforwards $ 90,035 $ 82,703 Research and development credit 15,566 15,509 Depreciable assets 8,356 10,443 Accrued expenses 818 719 Deferred revenue — 449 Intangible assets 361 415 Stock-based compensation 373 332 Other 22 63 Net deferred tax asset 115,531 110,633 Less: valuation allowance (115,531) (110,633) 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 2021 $ 7,479 $ — $ 334 $ 1,962 $ — 2022 22,420 — 483 1,610 — 2023 22,398 — 322 929 — 2024 25,032 — 213 663 — 2025 and thereafter 251,631 382,688 7,080 13,813 — Indefinite 91,838 — — — 9,310 Totals $ 420,798 $ 382,688 $ 8,432 $ 18,977 $ 9,310 |
ORGANIZATION AND NATURE OF OP_2
ORGANIZATION AND NATURE OF OPERATIONS - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Net loss | $ (20,913) | $ (23,877) |
Net cash used in operating activities | (20,034) | (35,981) |
Cash and cash equivalents | 30,115 | 7,232 |
Accumulated Deficit | $ 105,893 | $ 84,980 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)segment | Dec. 31, 2019USD ($) | |
Property, Plant and Equipment [Line Items] | ||
Number of operating segments | segment | 1 | |
Depreciation | $ | $ 10 | $ 28 |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | three | |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | five years |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value of Assets and Liabilities Measured on a Recurring Basis (Details) - Fair Value, Recurring - Fair Value, Inputs, Level 1 - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Money market funds | $ 29,182 | $ 7,232 |
U.S. treasuries | 0 | 4,497 |
Total | $ 29,182 | $ 11,729 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
May 31, 2018 | Mar. 31, 2015 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue recognized | $ 1,822,000 | $ 7,917,000 | ||
Deferred revenue | 0 | 1,795,000 | ||
Royalty revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue recognized | $ 27,000 | 0 | ||
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 | 7,900,000 | ||
Deferred revenue | 0 | $ 1,800,000 | ||
Milestone payment received | 10,000,000 | |||
Collaborative Arrangement | Royalty revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue recognized | $ 27,000 |
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, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 45,221,056 | 1,246,647 |
Outstanding warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 40,389,431 | 720,982 |
Outstanding options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 4,688,625 | 525,665 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 143,000 | 0 |
ACCRUED LIABILITIES - Summary o
ACCRUED LIABILITIES - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued contracted research and development services | $ 3,733 | $ 4,532 |
Accrued compensation | 1,369 | 59 |
Accrued professional fees | 318 | 1,788 |
Total | $ 5,420 | $ 6,379 |
CONVERTIBLE PROMISSORY NOTES -
CONVERTIBLE PROMISSORY NOTES - Narrative (Details) - USD ($) | Aug. 31, 2019 | Mar. 31, 2019 | Aug. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 31, 2020 |
Short-term Debt [Line Items] | ||||||
Proceeds from issuance of convertible promissory notes | $ 0 | $ 7,397,000 | ||||
Exercise price (in usd per share) | $ 0.72 | |||||
Warrant liability | $ 1,500,000 | |||||
Derivative liability, fair value | $ 1,400,000 | |||||
Gain on extinguishment | $ 0 | 2,318,000 | ||||
Convertible Promissory Notes | ||||||
Short-term Debt [Line Items] | ||||||
Stated rate | 12.00% | |||||
Debt term | 1 year | |||||
Proceeds from issuance of convertible promissory notes | $ 7,400,000 | |||||
Conversion price (in usd per share) | $ 7.54 | $ 7.54 | ||||
Coverage percent | 50.00% | |||||
Stock issuable upon warrants (in shares) | 490,683 | |||||
Warrants term | 5 years | |||||
Exercise price (in usd per share) | $ 10.36 | |||||
Interest expense | $ 0 | 2,000,000 | ||||
Accretion of discounts | $ 800,000 | |||||
Effective rate | 12.00% | |||||
Gain on extinguishment | $ 2,300,000 | |||||
Convertible Promissory Notes | Common Stock | ||||||
Short-term Debt [Line Items] | ||||||
Shares issued in conversion (in shares) | 1,069,740 | |||||
Officers and Directors | Convertible Promissory Notes | ||||||
Short-term Debt [Line Items] | ||||||
Proceeds from issuance of convertible promissory notes | $ 1,700,000 |
NOTE PAYABLE - Narrative (Detai
NOTE PAYABLE - Narrative (Details) - USD ($) | Sep. 03, 2019 | Feb. 18, 2016 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | Apr. 15, 2020 |
Debt Instrument [Line Items] | ||||||
Payments of principal of note payable | $ (2,600,000) | $ 0 | $ (4,808,000) | |||
Payment of associated accrued interest and aggregate end-of-term payment | $ 600,000 | |||||
Paycheck Protection Program | ||||||
Debt Instrument [Line Items] | ||||||
Face amount | $ 400,000 | |||||
Stated rate | 1.00% | |||||
Note Payable | ||||||
Debt Instrument [Line Items] | ||||||
Face amount | $ 7,500,000 | |||||
Facility fees | $ 200,000 | |||||
Interest Rate Option 1 | Note Payable | ||||||
Debt Instrument [Line Items] | ||||||
Stated rate | 9.20% | |||||
Interest Rate Option 2 | Note Payable | ||||||
Debt Instrument [Line Items] | ||||||
Stated rate | 9.20% | |||||
Interest Rate Option 2 | Note Payable | Prime Rate | ||||||
Debt Instrument [Line Items] | ||||||
Basis spread on variable rate | 3.50% | |||||
Hercules Capital Warrants | ||||||
Debt Instrument [Line Items] | ||||||
Warrants converted (in shares) | 9,005 | |||||
Exercise price (in usd per share) | $ 33.31 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) | Feb. 17, 2020USD ($) | Oct. 31, 2020USD ($)shares | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($)ft²renewal_term | Dec. 31, 2019USD ($) | Aug. 31, 2016 |
Loss Contingencies [Line Items] | ||||||
Lease term | 5 years | |||||
Number of additional terms | renewal_term | 2 | |||||
Renewal term | 3 years | |||||
Area of leased property | ft² | 3,038 | |||||
Monthly payment, initial year | $ 4,430 | |||||
Annual payment percentage increase | 3.50% | |||||
Monthly fees | $ 2,160 | |||||
Discount rate | 12.00% | |||||
Expected remaining term | 2 years 9 months 18 days | |||||
Amortization of operating lease right-of-use assets | $ 100,000 | |||||
Lease expense | 100,000 | $ 100,000 | ||||
Research and development | 11,216,000 | $ 20,214,000 | ||||
Bodor Laboratories, Inc. | ||||||
Loss Contingencies [Line Items] | ||||||
Non-refundable upfront fees | $ 1,000,000 | |||||
Cash payment | 1,800,000 | $ 500,000 | ||||
Payments for additional product approval | 100,000 | |||||
Value of shares issued in agreement | $ 1,500,000 | $ 500,000 | ||||
Shares issued in agreement (in shares) | shares | 480,769 | |||||
Milestone payment | $ 500,000 | |||||
Research and development | $ 1,500,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Schedule of Contractual Obligations (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Less than 1 year | $ 78 |
Imputed interest | (4) |
Total | $ 74 |
CAPITAL STOCK - Narrative (Deta
CAPITAL STOCK - Narrative (Details) | Feb. 17, 2020USD ($)$ / sharesshares | Oct. 31, 2020USD ($)$ / sharesshares | Jun. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Sep. 30, 2020$ / shares | Apr. 14, 2020USD ($) | Dec. 31, 2019$ / sharesshares |
Class of Stock [Line Items] | |||||||
Common stock, shares authorized (in shares) | 100,000,000 | 50,000,000 | |||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | |||||
Common stock, shares issued (in shares) | 53,551,461 | 8,480,968 | |||||
Exercise price (in usd per share) | $ / shares | $ 0.72 | ||||||
Sale of stock, expiration term | 5 years | ||||||
Aggregate purchase price for stock and warrants | $ | $ 200,000 | ||||||
Preferred shares authorized (in shares) | 5,000,000 | ||||||
Temporary equity, par or stated value per share (in dollars per share) | $ / shares | $ 0.01 | ||||||
Preferred stock shares outstanding (in shares) | 0 | ||||||
Pre-Funded Warrant | |||||||
Class of Stock [Line Items] | |||||||
Exercise price (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | |||||
Common Stock Public Offering | |||||||
Class of Stock [Line Items] | |||||||
Common stock, shares issued (in shares) | 14,790,133 | ||||||
Exercise price (in usd per share) | $ / shares | $ 1.25 | ||||||
Sale of stock, expiration term | 5 years | ||||||
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 | ||||||
At Market Issuance Sales Agreement | |||||||
Class of Stock [Line Items] | |||||||
Number of shares issued in transaction (in shares) | 4,360,167 | ||||||
Closing sale price (in dollars per share) | $ / shares | $ 0.85 | ||||||
Aggregate offering price | $ | $ 8,000,000 | ||||||
Consideration received on transaction | $ | $ 3,400,000 | ||||||
Sale of stock, Percentage Of Commission | 0.03 | ||||||
Private Placement Offerings | |||||||
Class of Stock [Line Items] | |||||||
Common stock, shares issued (in shares) | 950,000 | ||||||
Aggregate gross purchase price | $ | $ 2,000,000 | ||||||
Private Placement Offerings | Series A | |||||||
Class of Stock [Line Items] | |||||||
Stock issuable upon warrants (in shares) | 606,420 | ||||||
Exercise price (in usd per share) | $ / shares | $ 0.01 | ||||||
Private Placement Offerings | Series B | |||||||
Class of Stock [Line Items] | |||||||
Stock issuable upon warrants (in shares) | 1,556,420 | ||||||
Exercise price (in usd per share) | $ / shares | $ 1.16 | ||||||
October 2020 Offering | |||||||
Class of Stock [Line Items] | |||||||
Number of shares authorized to be repurchased (in shares) | 20,833,322 | ||||||
Consideration received on transaction | $ | $ 13,700,000 | ||||||
Commissions discounts and other offering expenses | $ | $ 1,300,000 | ||||||
October 2020 Offering | Pre-Funded Warrant | |||||||
Class of Stock [Line Items] | |||||||
Closing sale price (in dollars per share) | $ / shares | $ 0.719 | ||||||
October 2020 Offering | Common Stock | |||||||
Class of Stock [Line Items] | |||||||
Number of shares issued in transaction (in shares) | 19,003,510 | ||||||
October 2020 Offering | Common stock warrants | |||||||
Class of Stock [Line Items] | |||||||
Number of shares authorized to be repurchased (in shares) | 1,829,812 | ||||||
Closing sale price (in dollars per share) | $ / shares | $ 0.72 | ||||||
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% | ||||||
Lincoln Park | Purchase Agreement | |||||||
Class of Stock [Line Items] | |||||||
Closing sale price (in dollars per share) | $ / shares | $ 3 | ||||||
Maximum shares allowed to be purchased | 100,000 | ||||||
Maximum share increase amount | 125,000 | ||||||
Lincoln Park | Regular Purchase | |||||||
Class of Stock [Line Items] | |||||||
Closing sale price (in dollars per share) | $ / shares | $ 5 | ||||||
Maximum share increase amount | 150,000 |
CAPITAL STOCK - Reserved Author
CAPITAL STOCK - Reserved Authorized Shares of Common Stock (Details) | Dec. 31, 2020shares |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance (in shares) | 47,283,591 |
Outstanding warrants | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance (in shares) | 40,389,431 |
Common stock options outstanding | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance (in shares) | 4,688,625 |
Unvested restricted stock units | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance (in shares) | 143,000 |
2020 Omnibus Plan | Outstanding options | |
Class of Stock [Line Items] | |
Shares available for grant (in shares) | 2,062,535 |
STOCK-BASED COMPENSATION - Narr
STOCK-BASED COMPENSATION - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Estimated forfeiture rate | 11.00% | ||
2020 Omnibus Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares authorized (in shares) | 5,125,000 | ||
Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options outstanding (in shares) | 4,688,625 | 1,793,602 | |
Granted (in shares) | 3,309,334 | 1,088,260 | |
Weighted-average grant date fair value (in dollars per share) | $ 0.52 | $ 3.30 | |
Weighted average exercise price, granted (in usd per share) | $ 0.80 | $ 4.67 | |
Unrecognized share-based compensation expense | $ 4.7 | ||
Unrecognized share-based compensation expense, period for recognition | 2 years 8 months 12 days | ||
Options | 2020 Omnibus Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares of common stock reserved for future issuance (in shares) | 4,500,000 | ||
Options outstanding (in shares) | 3,295,832 | ||
Shares available for grant (in shares) | 2,062,535 | ||
Options | 2009 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options outstanding (in shares) | 1,282,381 | ||
Shares available for grant (in shares) | 0 | ||
Options | Vical Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options outstanding (in shares) | 253,412 | ||
Shares available for grant (in shares) | 0 | ||
Unvested restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized share-based compensation expense | $ 0.1 | ||
Unrecognized share-based compensation expense, period for recognition | 2 months 12 days | ||
Aggregate intrinsic value outstanding | $ 0.2 | ||
Aggregate intrinsic value vested | $ 0.2 |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair Value Assumptions (Details) - Weighted average | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years | 6 years 1 month 6 days |
Expected volatility | 73.00% | 83.20% |
Risk-free interest rate | 0.40% | 1.40% |
Expected dividend yield | 0.00% | 0.00% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) - Outstanding options - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Shares | ||
Options outstanding (in shares) | 1,793,602 | |
Granted (in shares) | 3,309,334 | 1,088,260 |
Forfeited or expired (in shares) | (414,311) | |
Options outstanding (in shares) | 4,688,625 | 1,793,602 |
Options vested and exercisable (in shares) | 809,309 | |
Weighted Average Exercise Price | ||
Weighted average exercise price (in usd per share) | $ 13 | |
Weighted average exercise price, granted (in usd per share) | 0.80 | $ 4.67 |
Weighted average exercise price, forfeited or expired (in usd per share) | 9.98 | |
Weighted Average Exercise Price (in usd per share) | 4.66 | $ 13 |
Options vested and exercisable (in usd per share) | $ 18.37 | |
Total Intrinsic Value | ||
Intrinsic Value, Outstanding | $ 0 | $ 4,971 |
Intrinsic Value, Options vested and exercisable | $ 0 | |
Weighted Average Remaining Contractual Life (In Years) | ||
Weighted Average Remaining Contractual Life (In Years), Outstanding | 9 years 14 days | 8 years 5 months 26 days |
Weighted Average Remaining Contractual Life (In Years), Options vested and exercisable | 6 years 9 months |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock unit Activity (Details) - Unvested restricted stock units | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Shares | |
Unvested at beginning of period (in shares) | shares | 0 |
Granted (in shares) | shares | 360,205 |
Vested (in shares) | shares | (170,037) |
Forfeited (in shares) | shares | (47,168) |
Unvested at End of period (in shares) | shares | 143,000 |
Weighted Average Grant Date Fair Value | |
Unvested at beginning of period (in usd per share) | $ / shares | $ 0 |
Granted (in usd per share) | $ / shares | 1.21 |
Vested (in usd per share) | $ / shares | 1.04 |
Forfeited (in usd per share) | $ / shares | 1.35 |
Unvested at end of period (in usd per share) | $ / shares | $ 1.38 |
STOCK-BASED COMPENSATION - Shar
STOCK-BASED COMPENSATION - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,993 | $ 1,532 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 392 | 349 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,601 | $ 1,183 |
INCOME TAXES - Effective Income
INCOME TAXES - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
State taxes, net of federal benefit | 3.80% | 3.16% |
Research and development tax credits | 0.11% | 3.25% |
Permanent differences and other | 0.18% | (2.51%) |
Transaction costs | 0.00% | (1.88%) |
Stock-based compensation | (1.35%) | (1.02%) |
Change in tax rate | (0.32%) | 0.02% |
Change in deferred tax asset valuation allowance | (23.42%) | (22.02%) |
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, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 90,035 | $ 82,703 |
Research and development credit | 15,566 | 15,509 |
Depreciable assets | 8,356 | 10,443 |
Accrued expenses | 818 | 719 |
Deferred revenue | 0 | 449 |
Intangible assets | 361 | 415 |
Stock-based compensation | 373 | 332 |
Other | 22 | 63 |
Net deferred tax asset | 115,531 | 110,633 |
Less: valuation allowance | (115,531) | (110,633) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | ||
Net deferred tax asset | $ 115,531 | $ 110,633 |
Research and development credit | 15,566 | 15,509 |
Increase (decrease) in deferred tax asset valuation allowance | (4,900) | 95,400 |
Unrecognized tax benefits | 21,700 | 21,700 |
Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 420,798 | 403,900 |
Operating loss carryforwards, not subject to expiration | 29,100 | 25,100 |
State and Local Jurisdiction | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 382,688 | 350,800 |
Vical | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 76,900 | 332,900 |
Tax credit carryforwards | 23,500 | |
Research and development credit | 9,300 | 9,300 |
Vical | Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development credit | 8,200 | |
Federal research and development credits and orphan drug credit | Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | $ 27,700 | $ 30,300 |
INCOME TAXES - Summary of Feder
INCOME TAXES - Summary of Federal and State Carryforwards and Credits Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Federal NOLs | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 420,798 | $ 403,900 |
Federal NOLs | 2021 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 7,479 | |
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 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 251,631 | |
Federal NOLs | Indefinite | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 91,838 | |
State NOLs | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 382,688 | $ 350,800 |
State NOLs | 2021 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 0 | |
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 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 382,688 | |
State NOLs | Indefinite | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 0 | |
Federal R&D Credit | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 8,432 | |
Federal R&D Credit | 2021 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 334 | |
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 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 7,080 | |
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 | 18,977 | |
Federal Orphan Drug Credit | 2021 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 1,962 | |
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 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 13,813 | |
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 | 9,310 | |
State R&D Credit | 2021 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
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 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
State R&D Credit | Indefinite | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | $ 9,310 |
SUBSEQUENT EVENTS - Narrative (
SUBSEQUENT EVENTS - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||
Jan. 31, 2021 | Mar. 09, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 31, 2020 | |
Subsequent Event [Line Items] | |||||
Exercise price (in usd per share) | $ 0.72 | ||||
Proceeds from the exercise of warrants | $ 26 | $ 47 | |||
At Market Issuance Sales Agreement | |||||
Subsequent Event [Line Items] | |||||
Number of shares issued in transaction (in shares) | 4,360,167 | ||||
Closing sale price (in dollars per share) | $ 0.85 | ||||
Consideration received on transaction | $ 3,400 | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Stock issuable upon warrants (in shares) | 12,294,887 | ||||
Proceeds from the exercise of warrants | $ 8,900 | ||||
Subsequent Event | At Market Issuance Sales Agreement | |||||
Subsequent Event [Line Items] | |||||
Number of shares issued in transaction (in shares) | 1,083,548 | ||||
Closing sale price (in dollars per share) | $ 1.55 | ||||
Consideration received on transaction | $ 1,600 |