COVER PAGE
COVER PAGE - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 12, 2020 | Jun. 28, 2019 | |
Cover page. | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2019 | ||
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 | ||
Entity Shell Company | false | ||
Entity Public Float | $ 19.4 | ||
Entity Common Stock, Shares Outstanding | 9,669,402 | ||
Entity Central Index Key | 0000819050 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2019 | ||
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 7,232 | $ 8,067 |
Marketable securities, available-for-sale | 4,497 | 0 |
Prepaid expenses and other current assets | 6,240 | 204 |
Total current assets | 17,969 | 8,271 |
Property and equipment, net | 16 | 37 |
Operating lease right-of-use asset | 159 | |
Intangible assets | 0 | 441 |
Total assets | 18,144 | 8,749 |
Current liabilities: | ||
Accounts payable | 2,245 | 4,067 |
Accrued liabilities | 6,379 | 3,272 |
Lease liability, current portion | 78 | |
Deferred revenue, current portion | 1,795 | 8,117 |
Note payable | 0 | 4,639 |
Total current liabilities | 10,497 | 20,095 |
Lease liability, net of current portion | 73 | |
Contingent consideration | 0 | 145 |
Warrant liability | 0 | 242 |
Deferred revenue, net of current portion | 0 | 1,595 |
Total liabilities | 10,570 | 22,077 |
Redeemable convertible preferred stock (Series A, B, C and C-1), $0.01 par value, 5,000,000 and 4,182,943 shares authorized at December 31, 2019 and 2018, respectively; 0 and 1,256,466 shares issued and outstanding at December 31, 2019 and 2018, respectively; aggregate liquidation preference of $0 and $46,985 at December 31, 2019 and 2018, respectively | 0 | 58,290 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity (deficit): | ||
Common stock, $0.01 par value, 50,000,000 and 8,000,000 shares authorized at December 31, 2019 and 2018, respectively; 8,480,968 and 589,001 shares issued and outstanding at December 31, 2019 and 2018, respectively | 85 | 6 |
Additional paid-in capital | 92,497 | 0 |
Accumulated other comprehensive loss | (28) | 0 |
Accumulated deficit | (84,980) | (71,624) |
Total stockholders’ equity (deficit) | 7,574 | (71,618) |
Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit) | $ 18,144 | $ 8,749 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (PARENTHETICAL) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Redeemable convertible preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Redeemable convertible preferred stock, shares authorized (in shares) | 5,000,000 | 4,182,943 |
Redeemable convertible preferred stock, shares issued (in shares) | 0 | 1,256,466 |
Redeemable convertible preferred stock, shares outstanding (in shares) | 0 | 1,256,466 |
Redeemable convertible preferred stock, liquidation preference (in usd) | $ 0 | $ 46,985 |
Common stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 50,000,000 | 8,000,000 |
Common stock, shares issued (in shares) | 8,480,968 | 589,001 |
Common stock, shares outstanding (in shares) | 8,480,968 | 589,001 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | ||
Collaboration revenue | $ 7,917 | $ 10,888 |
Operating expenses: | ||
Research and development | 20,214 | 12,960 |
General and administrative | 12,171 | 6,379 |
Total operating expenses | 32,385 | 19,339 |
Loss from operations | (24,468) | (8,451) |
Investment and other income, net | 157 | 61 |
Gain on extinguishment | 2,318 | 0 |
Interest expense | (2,096) | (1,090) |
Change in fair value of derivative liability | (11) | 0 |
Change in fair value of warrant liability | 223 | 244 |
Net loss | (23,877) | (9,236) |
Reduction (accretion) of redeemable convertible preferred stock to redemption value | 10,274 | (5,936) |
Net loss attributable to common stockholders | $ (13,603) | $ (15,172) |
Net loss per share attributable to common stockholders, basic and diluted (in usd per share) | $ (4.50) | $ (25.85) |
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted (in shares) | 3,023,023 | 586,969 |
CONDENSED CONSOLIDATED STATMENT
CONDENSED CONSOLIDATED STATMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (23,877) | $ (9,236) |
Other comprehensive loss: | ||
Unrealized loss on available-for-sale marketable securities arising during holding period, net of tax benefit of $0 | (28) | 0 |
Total comprehensive loss | $ (23,905) | $ (9,236) |
CONDENSED CONSOLIDATED STATME_2
CONDENSED CONSOLIDATED STATMENTS OF COMPREHENSIVE LOSS (PARENTHETICAL) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Unrealized loss arising during holding period, tax benefit (expense) | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Series A, B, C & C-1 Redeemable Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Redeemable Convertible Preferred Stock and Preferred Stock Dividends to Common Stock | Redeemable Convertible Preferred Stock and Preferred Stock Dividends to Common StockSeries A, B, C & C-1 Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock and Preferred Stock Dividends to Common StockCommon Stock | Redeemable Convertible Preferred Stock and Preferred Stock Dividends to Common StockAdditional Paid-In Capital | Convertible Notes Payable and Accrued Interest to Common Stock | Convertible Notes Payable and Accrued Interest to Common StockCommon Stock | Convertible Notes Payable and Accrued Interest to Common StockAdditional Paid-In Capital |
Beginning Balance (in shares) at Dec. 31, 2017 | 585,262 | ||||||||||||
Beginning Balance at Dec. 31, 2017 | $ (59,936) | $ 6 | $ 0 | $ 0 | $ (59,942) | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Stock based compensation | 711 | 711 | |||||||||||
Issuance of common stock through exercise of stock option (in shares) | 3,739 | ||||||||||||
Issuance of common stock through exercise of stock option | 45 | 45 | |||||||||||
Accretion of redeemable convertible preferred stock to redemption value | (5,936) | (756) | (5,180) | ||||||||||
Net income (loss) | (9,236) | (9,236) | |||||||||||
Unrealized loss on available-for-sale marketable securities | $ 0 | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2018 | 589,001 | 589,001 | |||||||||||
Ending Balance at Dec. 31, 2018 | $ (71,618) | $ 6 | 0 | 0 | (71,624) | ||||||||
Beginning Balance (in shares) at Dec. 31, 2017 | 1,256,466 | ||||||||||||
Beginning Balance at Dec. 31, 2017 | $ 52,354 | ||||||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||||||
Accretion of redeemable convertible preferred stock to redemption value | $ 5,936 | ||||||||||||
Shares converted | $ 0 | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2018 | 1,256,466 | 1,256,466 | |||||||||||
Ending Balance at Dec. 31, 2018 | $ 58,290 | $ 58,290 | |||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Stock based compensation | $ 1,532 | 1,532 | |||||||||||
Issuance of common stock through exercise of stock option (in shares) | 0 | 670,288 | |||||||||||
Issuance of common stock through exercise of stock option | $ 47 | $ 7 | 40 | ||||||||||
Accretion of redeemable convertible preferred stock to redemption value | 10,274 | (247) | 10,521 | ||||||||||
Net income (loss) | (23,877) | (23,877) | |||||||||||
Conversion of securities (in shares) | 2,783,951 | 1,069,740 | |||||||||||
Conversion of securities | $ 48,016 | $ 28 | $ 47,988 | $ 5,092 | $ 10 | $ 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 | |||||||||||
Common stock warrants issued in connection with the research and development funding liability, net of cancellations | 532 | 532 | |||||||||||
Unrealized loss on available-for-sale marketable securities | $ (28) | (28) | |||||||||||
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) | ||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||||||
Accretion of redeemable convertible preferred stock to redemption value | $ (10,274) | ||||||||||||
Shares converted (in shares) | (1,256,466) | ||||||||||||
Shares converted | $ (48,016) | $ (48,016) | |||||||||||
Ending Balance (in shares) at Dec. 31, 2019 | 0 | 0 | |||||||||||
Ending Balance at Dec. 31, 2019 | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (23,877) | $ (9,236) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 28 | 49 |
Accretion of discount on marketable securities | (41) | 0 |
Non-cash interest expense | 666 | 0 |
Impairment expense | 441 | 0 |
Change in fair value of derivative liability | 11 | 0 |
Change in fair value of warrant liability | (223) | (244) |
Change in fair value of contingent consideration | (145) | (3) |
Gain on extinguishment | (2,318) | 0 |
Amortization of discounts and financing costs | 1,575 | 489 |
Stock-based compensation | 1,532 | 711 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (4,562) | (115) |
Accounts payable | (1,822) | 2,845 |
Accrued liabilities | 671 | (241) |
Deferred revenue | (7,917) | 9,712 |
Net cash provided by (used in) operating activities | (35,981) | 3,967 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Cash and cash equivalents acquired in recapitalization | 13,017 | 0 |
Maturities of marketable securities | 19,500 | 0 |
Capital expenditures | (7) | (12) |
Net cash provided by (used in) investing activities | 32,510 | (12) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payments of principal of note payable | (4,808) | (1,282) |
Payment of issuance costs associated with note payable | 0 | (50) |
Proceeds from issuance of convertible promissory notes | 7,397 | 0 |
Proceeds from the exercise of warrants | 47 | 0 |
Proceeds from the exercise of stock options | 0 | 45 |
Net cash provided by (used in) financing activities | 2,636 | (1,287) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (835) | 2,668 |
CASH AND CASH EQUIVALENTS—BEGINNING | 8,067 | 5,399 |
CASH AND CASH EQUIVALENTS—ENDING | 7,232 | 8,067 |
Supplement Disclosure of Cash Flow Information: | ||
Interest paid | 432 | 608 |
Supplement Disclosure of Non-Cash Investing and Financing Activities: | ||
Conversion of redeemable convertible preferred stock and preferred stock dividends to common stock | 48,016 | 0 |
Accretion (reduction) of redeemable convertible preferred stock to redemption value | (10,377) | 5,896 |
Shares issued in recapitalization | 23,076 | 0 |
Conversion of the convertible promissory notes and interest to common stock | 8,063 | 0 |
Accretion of redeemable convertible preferred stock issuance costs | 103 | 40 |
Derivative liability issued with convertible promissory notes | 1,442 | 0 |
Warrants to purchase common stock issued with funding agreement | 876 | 0 |
Warrants to purchase common stock issued with convertible promissory notes | 1,492 | 0 |
Change in unrealized loss on available-for-sale marketable securities | $ (28) | $ 0 |
ORGANIZATION AND NATURE OF OPER
ORGANIZATION AND NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2019 | |
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 the treatment of debilitating skin diseases. The Company’s pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. The Company’s pivotal Phase 3-ready clinical-stage product candidate, sofpironium bromide, is a proprietary new molecular 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, 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, Vical 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. These financial statements and related notes should be read in conjunction with the audited financial statements of Private Brickell for the year ended December 31, 2018, included in the Company’s Form 8-K/A filed with the Securities and Exchange Commission (the “SEC”) on February 10, 2020. On August 31, 2019, in connection with, and prior to the consummation of the Merger, Vical effected a reverse stock split of its common stock, par value $0.01 per share, at a ratio of 1-for-7 (the “Reverse Stock Split”). Unless otherwise noted herein, references to share and per-share amounts give retroactive effect to the Reverse Stock Split. On August 31, 2019, all shares of preferred stock of Private Brickell converted into shares of common stock of Private Brickell on a one -for-one basis. At the effective date of the Merger, the Company issued shares of its common stock to Private Brickell stockholders, at an exchange rate of approximately 2.4165 shares of common stock in exchange for each share of Private Brickell common stock outstanding immediately prior to the Merger (the “Exchange Ratio”). The exchange rate was calculated by a formula that was determined through arms-length negotiations between Vical and Private Brickell. Unless otherwise noted herein, references to share and per-share amounts give retroactive effect to the Reverse Stock Split and the Exchange Ratio, which was effected upon the Merger. Immediately following the consummation of the Merger, there were 7,810,680 shares of the Company’s common stock issued and outstanding, with Private Brickell’s former securityholders beneficially owning approximately 57% of the outstanding shares of common stock and Vical’s former securityholders beneficially owning approximately 43% of the outstanding shares of common stock. Liquidity and Capital Resources The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The consolidated financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. 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, 2019 , the Company had a net loss of $23.9 million and net cash used in operating activities of $36.0 million . As of December 31, 2019 , the Company had cash, cash equivalents, and marketable securities of $11.7 million , and an accumulated deficit of $85.0 million . The Company believes that its cash, cash equivalents, and marketable securities as of December 31, 2019 , combined with the refundable prepaid research and development expenses and periodic sales of the Company’s common stock under the Purchase Agreement (see Note 12 . “ Subsequent Events ”), are sufficient to fund its operations for at least the next 12 months from the issuance of these consolidated financial statements . In order to sell additional shares of common stock under the Purchase Agreement, Lincoln Park Capital Fund, LLC (“Lincoln Park”) will need to purchase shares of common stock from the Company, subject to the conditions under the Purchase Agreement, and the Company will be required to have an additional effective registration statement. The Company has filed a registration statement on Form S-3 covering the resale of the initial shares sold to Lincoln Park, which management will request the SEC to declare effective following the filing of this Form 10-K. If the Company is unable to raise additional capital, including under the Purchase Agreement, the Company expects to conserve resources, including reducing cash compensation arrangements to management and further reductions in operating expenditures. 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 beyond the sale of additional shares of common stock to Lincoln Park will be required in the future to proceed with the Company’s current and proposed research activities, including conducting the pivotal Phase 3 clinical trials of sofpironium bromide. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2019 | |
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 have been prepared in accordance with accounting principles generally accepted in the United States of America (“ US GAAP ”) and 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. The Merger has been accounted for as a recapitalization. Prior to the Merger, Vical wound down its pre-merger business assets and liabilities. The owners and management of Private Brickell have actual and effective voting and operating control of the combined company. In the Merger transaction, Vical is the accounting acquiree and Private Brickell is the accounting acquirer. A recapitalization is equivalent to the issuance of stock by the private operating company for the net monetary assets of the accounting acquiree accompanied by a recapitalization with accounting similar to that resulting from a reverse acquisition, except that no goodwill or intangible assets are recorded. In connection with the Merger, 3,367,988 shares of common stock were transferred to the existing Vical stockholders and the Company assumed approximately $36.1 million in net tangible assets from Vical, which were recorded as additional paid-in capital. The following table summarizes the net assets acquired based on their estimated fair values immediately prior to the Merger (in thousands): Cash and cash equivalents $ 13,017 Marketable securities 23,959 Prepaid expenses and other current assets 1,474 Accrued liabilities (2,357 ) Net acquired tangible assets $ 36,093 In connection with the Merger, the Company assumed warrants previously held by Vical, which provide the warrantholder the right to purchase 891,582 shares of common stock at an exercise price of $0.07 (the “Vical Warrants”). The Vical Warrants were classified as equity. In December 2019, warrants to purchase 670,288 shares of common stock were exercised for proceeds of $47 thousand . The combined company assumed all the outstanding options, under Vical’s equity incentive plan (the “Vical Plan”) with such options representing the right to purchase a number of shares of Brickell common stock previously represented by such options, as adjusted for the recapitalization. Use of Estimates The Company’s consolidated financial statements are prepared in accordance with US 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 production of 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 alliance management, 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 United States 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 complete clinical studies and launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be at terms acceptable by 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 $28 thousand and $49 thousand for the years ended December 31, 2019 and 2018 , respectively. Long-Lived Assets The Company’s intangible assets are considered indefinite-lived and are not amortized, but are tested for impairment on an annual basis, as well as between annual tests if changes in circumstances indicate a reduction in the fair value of the in-process research and development (“IPR&D”) projects below their respective carrying amounts. In connection with any impairment assessment, the fair value of the intangible assets as of the date of assessment is compared to the carrying value of the intangible asset. If and when development is complete, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives. During the year ended December 31, 2019 , the Company recorded within general administrative expenses a $0.4 million impairment charge related to two early-stage product candidates associated with the rights to an IPR&D molecular compound in the Phase 1 stage of development and with the rights to a RORg inhibitor associated with the topical treatment of mild-to-moderate psoriasis. These early-stage product candidates were acquired in 2015 in transactions that were accounted for as business combinations. Impairment was determined to have occurred in 2019 as changes in management’s plans indicated a reduction in the fair value of the IPR&D projects below their respective carrying amounts. These early-stage product candidates previously had contingent liabilities of $0.1 million associated with achieving certain future development milestones. The $0.1 million change in the fair value of the contingent consideration was recorded as general and administrative expense during the year ended December 31, 2019 . 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 tables set forth the fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): December 31, 2019 Level 1 Level 2 Level 3 Assets: Money market funds $ 7,232 $ — $ — U.S. treasuries 4,497 — — Total $ 11,729 $ — $ — December 31, 2018 Level 1 Level 2 Level 3 Assets: Money market funds $ 8,067 $ — $ — Liabilities: Redeemable convertible preferred stock warrant liability $ — $ — $ 242 Contingent consideration — — 145 Total $ — $ — $ 387 The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments as follows (in thousands): Derivative Common Redeemable Contingent Fair value as of December 31, 2018 $ — $ — $ 242 $ 145 Fair value of financial instruments issued 1,442 1,492 — — Change in fair value 11 17 (240 ) (145 ) Reclassification to equity (1,453 ) (1,509 ) (2 ) — Fair value as of December 31, 2019 $ — $ — $ — $ — 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 has designated its investments in U.S. treasury securities as available-for-sale securities and accounts for them at their respective fair values. The securities are classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Securities that are 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 that are 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. As of December 31, 2019 , the Company’s available-for-sale securities had an amortized cost of $4.5 million , fair value of $4.5 million , and an unrealized gain of $3 thousand . Because the securities were acquired in August 2019 in connection with the Merger, there were no related balances as of December 31, 2018 . Contingent Consideration— These amounts represented future payments in conjunction with various business combinations related to the acquisition of certain early-stage pipeline assets. These assets were impaired during the year ended December 31, 2019 , and therefore, the likelihood of future development and regulatory milestones and other potential future payments related to these assets was considered to be remote. The Company evaluated its estimates of the fair value of contingent consideration on a quarterly basis. The fair value of the contingent consideration was determined with the assistance of a third-party valuation firm applying the income approach. This approach estimated the fair value of the contingent consideration related to the achievement of future development and regulatory milestones by assigning an achievement probability and date of expected completion to each potential milestone and discounting the associated cash payment to its present value using a risk-adjusted rate of return. The probability of success of each milestone assumed that the prerequisite developmental milestones were successfully completed and was based on the asset’s current stage of development and anticipated regulatory requirements. The probability of success for each milestone was determined by multiplying the preceding probabilities of success. At December 31, 2018 , the unobservable inputs (Level 3 of the fair value hierarchy) to the valuation models that have the most significant effect on the fair value of the Company’s contingent consideration were the probabilities that certain in-process development projects would meet specified development milestones, including ultimate approval by the FDA, with individual cumulative probabilities ranging from 2.1% to 20.9% . Other unobservable inputs used in this approach include risk-adjusted discount rates ranging from 15.5% to 27.1% and estimates of the timing of the achievement of the various product development, regulatory approval, and sales milestones. Redeemable Convertible Preferred Stock Warrant Liability —These amounts represented potential future obligations to transfer assets to the holders at a future date. The Company remeasured these warrants to current fair value at each balance sheet date, and any change in fair value was recognized as a change in fair value of warrant liability in the consolidated statements of operations . The Company estimated the fair value of these warrants at December 31, 2018 using the Black-Scholes option-pricing model (Level 3 of the fair value hierarchy table). These warrants converted from warrants exercisable for redeemable convertible preferred stock to common stock in August 2019 in connection with the Merger (see further discussion in “ Note 6 . Note Payable ”). Inputs used to determine estimated fair value of the warrant liabilities included the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends, and the expected volatility of the underlying stock. The most significant unobservable inputs used in the fair value measurement of the convertible preferred stock warrant liability were the fair value of the underlying stock at the valuation date and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term resulted in a directionally similar impact to the fair value measurement. The fair value of the outstanding warrants was remeasured for the following period end using the Black-Scholes option-pricing model with the following assumptions: 2018 Expected term (in years) 7.1 Expected volatility 30.00 % Risk free interest rate 2.59 % Expected dividend yield — % The fair value of the shares of the convertible preferred stock underlying the preferred stock warrants was historically determined with the assistance of a third-party valuation firm. Because there had been no public market for the Company’s convertible preferred stock, the third-party valuation firm determined fair value of the convertible preferred stock at each balance sheet date by considering a number of objective and subjective factors, including valuation of comparable companies, sales of convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock, and general and industry specific economic outlook, among other factors. Remaining Term. The Company derived the expected term based on the time from the balance sheet date until the preferred stock warrant’s expiration date. Expected Volatility. Since the Company was previously a private entity prior to the Merger with no historical data regarding the volatility of its preferred stock, the expected volatility used was based on volatility of a group of similar entities. In evaluating similarity, the Company considered factors such as industry, stage of life cycle, and size. Risk-free Interest Rate . The risk-free interest rate was based on U.S. Treasury zero-coupon issues with remaining terms similar to the expected term of the warrants. Expected Dividend Rate . The Company has never paid any dividends and does not plan to pay dividends in the foreseeable future and, therefore, used an expected dividend rate of zero in the valuation model. Derivative Liability— These amounts represented potential future obligations to transfer assets to the holders at a future date. The fair value of the derivative liability has historically been determined with the assistance of a third-party valuation firm (Level 3 of the fair value hierarchy table) (see further discussion in “ Note 5 Convertible Promissory Notes ”). At the inception of the liability, there was no public market for the Company’s common stock, and a third-party valuation firm determined fair value of the stock by considering a number of objective and subjective factors, including valuation of comparable companies, sales of common stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock, and general and industry specific economic outlook, among other factors. The derivative liability was marked-to-market each measurement period and any change in fair value was recorded in the consolidated statements of operations . In August 2019, in connection with the Merger, the derivative liability was reclassified to equity in the consolidated balance sheet (see further discussion in “ Note 5 . Convertible Promissory Notes ”). Common Stock Warrant Liability —These amounts represented potential future obligations to transfer assets to the holders at a future date. The fair value of the warrants was historically determined with the assistance of a third-party valuation firm (Level 3 of the fair value hierarchy table) (see further discussion in Note 5 ). At the inception of the liability, there was no public market for the Company’s common stock, and a third-party valuation firm determined fair value of the stock by considering a number of objective and subjective factors, including valuation of comparable companies, sales of common stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock, and general and industry specific economic outlook, among other factors. The warrant liability was remeasured to fair value at each balance sheet date, and any change in fair value was recognized as a change in fair value of warrant liability in the consolidated statements of operations . The Company estimated the fair value of these warrants using the Black-Scholes option-pricing model. In August 2019, in connection with the Merger, the warrant liability was reclassified to equity in the consolidated balance sheet (see further discussion in “ Note 5 . Convertible Promissory Notes ”). Inputs used to determine estimated fair value of the warrant liabilities included the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends, and the expected volatility of the underlying stock. The most significant unobservable inputs used in the fair value measurement of the warrant liability were the fair value of the underlying stock at the valuation date and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term resulted in a directionally similar impact to the fair value measurement. Leases On January 1, 2019, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 842, Leases (“ASC 842”), using the modified retrospective method for all lease arrangements at the beginning of the period of adoption. Results for reporting periods beginning January 1, 2019 are presented under ASC 842, while prior period amounts were not adjusted and continue to be presented in accordance with the Company’s historical accounting under ASC Topic 840, Leases. ASC 842 had an impact on the Company’s consolidated balance sheets but did not have an impact on the Company’s net loss. 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 . Redeemable Convertible Preferred Stock Redeemable convertible preferred stock was classified as a mezzanine instrument outside of the Company’s capital accounts. Accretion of redeemable convertible preferred stock included the greater of an adjustment to fair market value or the accrual of dividends on and accretion of issuance costs of the Company’s redeemable convertible preferred stock. The carrying values of the redeemable convertible preferred stock were increased or reduced by periodic accretion or reduction to their respective redemption values from the date of issuance to August 31, 2019, the date that all outstanding shares of redeemable convertible preferred stock converted into shares of common stock. The carrying value adjustments were recorded as charges against additional paid-in capital balance. Preferred stock issuance costs represent costs related to the Company’s issuance of redeemable convertible preferred stock. These amounts were included as a reduction of redeemable convertible preferred stock and were amortized over the estimated redemption period until its conversion to common stock in August 2019. For the year ended December 31, 2019 and 2018 , amortization of preferred stock issuance costs amounted to approximately $0.1 million and $40 thousand , respectively. Redeemable Convertible Preferred Stock Warrants The Company accounted for warrants to purchase shares of its redeemable convertible preferred stock as liabilities at their estimated fair value because the underlying shares were redeemable, which obligated the Company to transfer assets to the holders at a future date. The warrants were subject to remeasurement to fair value at each balance sheet date, and any fair value adjustments were recognized as change in fair value of redeemable convertible preferred stock warrant liability in the consolidated statements of operations . The Company continued to adjust the liability for changes in fair value until the conversion of the redeemable convertible preferred stock into common stock in August 2019. At that time, the redeemable convertible preferred stock warrant liability was adjusted to fair value in the consolidated statements of operations with the final fair value reclassified to equity. 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’s drug candidates have not been approved for sale by the FDA or any other country’s regulatory authority, and the Company has not generated or recognized any revenue from the sale of products. In March 2015, the Company entered into a license, development, and commercialization agreement (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 (formerly BBI-4000), 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 and, until such time, if any, as Kaken elects to establish its own source of supply of drug product, Kaken can purchase product supply from the Company to perform all non-clinical studies, and Phase 1 and Phase 2 clinical trials in Japan at cost. Kaken is 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 United States. 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 fees were representative of this type of a 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, adjust the measure of performance and related revenue recognition on a prospective basis. Under 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. 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 is contingent upon success in future clinical trials and regulatory approvals, each of which is uncertain at this time. The Company will re-evaluate 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 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 it does 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. Under Topic 606, the entire transaction price of $11.0 million was allocated to the license performance obligation. The license was deemed to be delivered in 2015 in connection with the execution of the Kaken Agreement and upon transfer of the underlying intellectual property the performance obligation was fully satisfied. As a result, a cumulative adjustment to reduce deferred revenue and the corresponding sublicensing costs of $2.7 million was recorded upon the adoption of Topic 606 on January 1, 2018. As of December 31, 2019 , the Company does not have a deferred revenue or deferred sublicensing costs balance related to the upfront fee on the consolidated balance sheet . In May 2018, the Company entered into an amendment to the Kaken Agreement (as further amended, “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 NDA 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 these under the provisions of Topic 606. This Kaken R&D Payment will be initially recognized using an input method over the average estimated performance period of 1.45 years 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. Consequently, during the year ended December 31, 2019 and 2018, the Company recognized revenue of $ |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | RECENT ACCOUNTING PRONOUNCEMENTS In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which amends certain disclosure requirements over Level 1, Level 2, and Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2018-13, but does not anticipate it will have a material impact on its disclosures. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). ASU 2016-02 is aimed at making leasing activities more transparent and comparable and requires substantially all leases be recognized by lessees on their balance sheets as a right-of-use asset and corresponding lease liability, including leases currently accounted for as operating leases. The Company adopted ASU 2016-02 on January 1, 2019 using the modified retrospective approach. The adoption did not have a material impact on the Company’s consolidated statements of operations . The new standard has required the Company to establish liabilities and corresponding right-of-use assets on its consolidated balance sheet for operating leases of $0.2 million that existed as of the January 1, 2019 adoption date. The impact on the consolidated balance sheets as of January 1, 2019 was as follows (in thousands): Balance Sheet Topic 840 January 1, 2019 Topic 842 January 1, 2019 Impact of Operating lease right-of-use asset $ — $ 219 $ 219 Lease liability, current portion — (68 ) (68 ) Lease liability, net of current portion — (151 ) (151 ) |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
ACCRUED LIABILITIES | ACCRUED LIABILITIES Accrued liabilities consisted of the following (in thousands): December 31, 2019 2018 Accrued contracted research and development services $ 4,532 $ 847 Accrued professional fees 1,788 1,269 Accrued compensation 59 569 Accrued note payable issuance costs — 587 Total $ 6,379 $ 3,272 |
CONVERTIBLE PROMISSORY NOTES
CONVERTIBLE PROMISSORY NOTES | 12 Months Ended |
Dec. 31, 2019 | |
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 12.00% with a maturity of one year and convertible into shares of Series C-1 redeemable convertible preferred stock or the most senior preferred equity outstanding at the time of conversion at the option of the holder at a conversion price of $31.05 per share. In addition, the Prom Notes were automatically convertible upon closing of a qualified financing of at least $15.0 million before maturity at a conversion price equal to 80% of the effective price per share paid in the qualified financing, but not to exceed $38.82 per share. 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 “Conversion”). 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 . Prior to the Merger, the warrants were exercisable at an exercise price of $42.70 or 10% premium to the effective price per share paid in a qualified financing. The Company evaluated the various financial instruments under ASC 480 and 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 because the exercise price of the Prom Notes are subject to a variable conversion rate. The Company determined that the variable conversion feature was a redemption feature that was not clearly and closely related to the Prom Notes and was therefore required to be bifurcated. In accordance with AC 815, the Company bifurcated the conversion feature of the Prom Notes and recorded a derivative liability. The embedded derivative for the Prom Notes was carried on the Company’s consolidated balance sheet 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. The Company evaluated the conversion option to discern whether a beneficial conversion feature existed based upon comparing the effective exercise price of the convertible notes to the fair value of the shares they were convertible into. The Company concluded no beneficial conversion feature existed. 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 12.00% . 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 is included in the gain on extinguishment line in the consolidated statements of operations . NOTE PAYABLE 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% ; notwithstanding the above, such rate could not exceed the permissible rates of interest on commercial loans under the laws of the State of California. 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 was required to make an end of term payment of 4.5% of the sum of (i) term loan advances, plus (ii) 50% of the aggregate unfunded term loan commitments. The Loan Agreement was further amended in December 2017, March 2018, and July 2018 (as further amended, “Loan Agreement”) to provide for an additional combined interest-only period of eight months, and the outstanding loan balance continued to be paid in equal monthly installments of principal and interest. As a result of the amendments, the Company was required to increase the end-of-term payment by $0.1 million . At the inception of the loan and the following amendment dates, 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. The fair value of the Hercules Capital Warrants on the date of issuance of $0.3 million was determined using the Black-Scholes option-pricing model and was recorded as a debt discount upon issuance and was amortized to interest expense over the term of the loan based on the effective interest method. 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 sheet . As of December 31, 2019 , there were no remaining unaccreted debt discounts and issuance costs. |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
NOTE PAYABLE | 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 12.00% with a maturity of one year and convertible into shares of Series C-1 redeemable convertible preferred stock or the most senior preferred equity outstanding at the time of conversion at the option of the holder at a conversion price of $31.05 per share. In addition, the Prom Notes were automatically convertible upon closing of a qualified financing of at least $15.0 million before maturity at a conversion price equal to 80% of the effective price per share paid in the qualified financing, but not to exceed $38.82 per share. 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 “Conversion”). 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 . Prior to the Merger, the warrants were exercisable at an exercise price of $42.70 or 10% premium to the effective price per share paid in a qualified financing. The Company evaluated the various financial instruments under ASC 480 and 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 because the exercise price of the Prom Notes are subject to a variable conversion rate. The Company determined that the variable conversion feature was a redemption feature that was not clearly and closely related to the Prom Notes and was therefore required to be bifurcated. In accordance with AC 815, the Company bifurcated the conversion feature of the Prom Notes and recorded a derivative liability. The embedded derivative for the Prom Notes was carried on the Company’s consolidated balance sheet 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. The Company evaluated the conversion option to discern whether a beneficial conversion feature existed based upon comparing the effective exercise price of the convertible notes to the fair value of the shares they were convertible into. The Company concluded no beneficial conversion feature existed. 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 12.00% . 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 is included in the gain on extinguishment line in the consolidated statements of operations . NOTE PAYABLE 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% ; notwithstanding the above, such rate could not exceed the permissible rates of interest on commercial loans under the laws of the State of California. 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 was required to make an end of term payment of 4.5% of the sum of (i) term loan advances, plus (ii) 50% of the aggregate unfunded term loan commitments. The Loan Agreement was further amended in December 2017, March 2018, and July 2018 (as further amended, “Loan Agreement”) to provide for an additional combined interest-only period of eight months, and the outstanding loan balance continued to be paid in equal monthly installments of principal and interest. As a result of the amendments, the Company was required to increase the end-of-term payment by $0.1 million . At the inception of the loan and the following amendment dates, 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. The fair value of the Hercules Capital Warrants on the date of issuance of $0.3 million was determined using the Black-Scholes option-pricing model and was recorded as a debt discount upon issuance and was amortized to interest expense over the term of the loan based on the effective interest method. 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 sheet . As of December 31, 2019 , there were no remaining unaccreted debt discounts and issuance costs. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2019 | |
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 12.0% , the Company’s estimated incremental borrowing rate, 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 clinical trials progress 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, 2019 , and was included in operating expense. As of December 31, 2019 , the remaining lease term was 1.8 years . The terms of the Boulder Lease provide for rental payments on a monthly basis on a graduated scale. Lease expense for the years ended December 31, 2019 and 2018 was $0.1 million . The following is a summary of the contractual obligations related to operating lease commitments as of December 31, 2019 and the effect such obligations are expected to have on the liquidity and cash flows in future periods (in thousands): Less than 1 year $ 84 1-3 years 77 3-5 years — More than 5 years — Imputed interest (10 ) Total $ 151 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION Equity Incentive Plans The Company’s 2009 Equity Incentive Plan, as amended and restated (the “2009 Plan”), provides for the Company to sell or issue common stock or restricted common stock, or to grant incentive stock options or nonqualified stock options for the purchase of common stock, to employees, members of the board of directors, and consultants of the Company. At December 31, 2019 , the total shares authorized under the 2009 Plan were 1,634,655 shares. The board of directors or a designated committee of the board of directors is responsible for the administration of the 2009 Plan and determines the term, exercise price, and vesting terms of each option. Options granted under the 2009 Plan have an exercise price equal to the market value of the common stock at the date of grant and expire ten years from the date of grant. At December 31, 2019 , a total of 59,011 shares were available for grant under the 2009 Plan. In connection with the Merger, the Company adopted Vical’s Equity Incentive Plan (the “Vical Plan”). At December 31, 2019 , the total shares authorized under the Vical Plan were 413,710 shares. The Vical Plan, as amended, provides for the Company to sell or issue common stock or restricted common stock, or to grant incentive stock options or nonqualified stock options for the purchase of common stock, to employees, members of the board of directors, and consultants of the Company. The plan provides for the grant of incentive and nonstatutory stock options and the direct award or sale of shares, including restricted stock. The exercise price of stock options must equal at least the fair market value of the underlying common stock on the date of grant. The maximum term of options granted under the plan is ten years . The Vical Plan also limits the number of options that may be granted to any plan participant in a single calendar year to 1,300,000 shares. At December 31, 2019 , a total of 86,584 shares were available for grant under the Vical Plan. A summary of stock option activity under the 2009 Plan and the Vical Plan is as follows, as converted associated with stock split and conversion: Shares Weighted Price Total Intrinsic Weighted Average (In Years) Outstanding at December 31, 2018 696,842 $ 13.21 Acquired under Vical Plan 184,087 $ 75.98 Granted 1,088,260 $ 4.67 Exercised — $ — Forfeited or expired (175,587 ) $ 28.22 Outstanding at December 31, 2019 1,793,602 $ 13.00 $ 4,971 8.49 Options vested and exercisable at December 31, 2019 525,665 $ 28.41 $ 73,878 5.97 Share-based Compensation Expense Total stock-based compensation expense related to stock options granted under the 2009 Plan and the Vical Plan was allocated as follows (in thousands): Year Ended 2019 2018 Research and development $ 349 $ 340 General and administrative 1,183 371 Total stock-based compensation expense $ 1,532 $ 711 As of December 31, 2019 , the Company had $5.7 million of total unrecognized share-based compensation expense, which is expected to be recognized over a period of approximately 3.32 years years. 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 7% based on past experience, 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 Granted to Employees During the year ended December 31, 2019 and 2018 , the Company granted 982,890 stock options and 252,681 stock options, respectively, to employees and non-employee directors to purchase shares of common stock with a weighted-average grant date fair value of $3.24 and $4.16 per share, respectively, and a weighted-average exercise price of $4.58 and $5.68 per share, respectively. The assumptions used to calculate the fair value of stock options granted to employees and non-employee directors under the 2009 Plan are as follows, presented on a weighted average basis: Year Ended 2019 2018 Expected term (in years) 6.1 6.1 Expected volatility 83.22 % 85.43 % Risk free interest rate 1.44 % 2.77 % Expected dividend yield — % — % Stock Options Granted to Non-employees During the year ended December 31, 2019 and 2018 , the Company granted 105,370 stock options and 15,188 stock options, respectively, to persons other than employees and non-employee members of the Company’s board of directors with a weighted-average exercise price of $5.53 and $5.68 per share, respectively. The assumptions used to calculate the fair value of stock options granted to non-employees under the 2009 Plan are as follows, presented on a weighted average basis: Year Ended 2019 2018 Expected term (in years) 6.02 9.96 Expected volatility 82.82 % 86.17 % Risk free interest rate 1.49 % 2.69 % Expected dividend yield — % — % |
CAPITAL STOCK
CAPITAL STOCK | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
CAPITAL STOCK | CAPITAL STOCK Common Stock 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, 2019 as follows: December 31, 2019 Common stock options outstanding 1,793,602 Common stock warrants 720,982 Options available for grant under the Vical Plan 86,584 Options available for grant under the 2009 Plan 59,011 Total 2,660,179 Preferred Stock In August 2019, in conjunction with the Merger, all outstanding shares of redeemable convertible preferred stock converted into shares of common stock at a ratio of 1:1 and were immediately exchanged for common stock at an Exchange Ratio of 2.4165 as a result of the Merger. Redeemable convertible preferred stock consisted of the following prior to the conversion on August 31, 2019 (in thousands, except share data): Preferred Preferred Par Carrying Common Series A 1,162,505 401,309 $ 4 $ 12,164 401,309 Series B 882,216 286,151 3 10,084 286,151 Series C 869,565 256,583 3 11,630 256,583 Series C-1 1,531,942 312,423 3 14,138 312,423 4,446,228 1,256,466 $ 13 $ 48,016 1,256,466 Redeemable convertible preferred stock consisted of the following as of December 31, 2018 (in thousands, except share data): Preferred Preferred Par Carrying Common Series A 1,162,505 401,309 $ 4 $ 16,098 401,309 Series B 882,216 286,151 3 13,011 286,151 Series C 869,565 256,583 3 13,018 256,583 Series C-1 1,268,657 312,423 3 16,163 312,423 4,182,943 1,256,466 $ 13 $ 58,290 1,256,466 As of December 31, 2019 , the Company had no outstanding shares of redeemable convertible preferred stock and had not designated the rights, preferences, or privileges of any class or series of preferred stock. Although, the Company’s board of directors has the authority, at its discretion, to issue preferred stock in one or more classes or series and to fix the designations, powers, preferences and rights, and the qualifications, limitations, or restrictions thereof, including dividend rights, conversion right, voting rights, terms of redemption, liquidation preferences, and the number of shares constituting any class or series of preferred stock, without further vote or action by the stockholders. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES During the years ended December 31, 2019 and 2018 , the Company recorded no income tax benefits for the net operating losses 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 2019 2018 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 3.16 3.71 Research and development tax credits 3.25 8.77 Permanent differences and other (2.51 ) 2.36 Transaction costs (1.88 ) — Stock-based compensation (1.02 ) — Change in tax rate 0.02 1.80 Change in deferred tax asset valuation allowance (22.02 ) (37.64 ) 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 2019 2018 Net operating loss carryforwards $ 82,703 $ 8,918 Research and development credit 15,509 3,207 Depreciable assets 10,443 — Accrued expenses 719 — Deferred revenue 449 2,040 Net book value of intangible assets 415 75 Stock-based compensation 332 520 Other 63 514 Net deferred tax asset 110,633 15,274 Less: valuation allowance (110,633 ) (15,274 ) Net deferred tax assets $ — $ — At December 31, 2019, the Company had deferred tax assets of $110.6 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. As of December 31, 2019 and 2018, the Company had available federal NOL carryforwards of approximately $403.9 million and $36.4 million , respectively. The NOL generated in 2019 of $25.1 million and 2018 of $2.4 million will carry forward indefinitely and be available to offset up to 80% of future taxable income each year. NOLs generated prior to 2018 will expire from 2019 through 2038 . In addition, the Company had federal research and development credits and orphan drug credit carryforwards of $30.3 million and $3.2 million as of December 31, 2019 and 2018 , respectively, to reduce future federal income taxes, if any. These carryforwards expire from 2019 through 2038 and are subject to review and possible adjustment by the IRC. The Company also has available state NOL carryforwards of approximately $350.6 million and $31.0 million as of December 31, 2019 and 2018 , respectively, which expire from 2028 to 2038 . In addition, through the Merger, the Company acquired Vical’s California research and development credits of approximately $9.3 million as of December 31, 2019 and 2018 , to reduce future California income tax, if any. The California research and development credits do not expire. Pursuant to Sections 382 and 383 of the Internal Revenue Code “IRC,” annual use of the Company’s net operating loss (“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. Vical completed a Section 382 analysis through December 31, 2011 and as a result of an ownership change on December 29, 2006, the Company estimates that $89.3 million of Vical’s acquired NOL carryforwards were effectively eliminated under Section 382 for federal tax purposes. The Company also estimates $10.8 million of Vical’s acquired research and development credits and other tax credits were effectively eliminated under Section 383 for federal purposes. Accordingly, after consideration of these limitations, the Company recorded federal and state NOL carryforward of $253.1 million and $291.5 million , respectively, and federal and state credit carryforwards of $24.6 million as a result of the Merger. Vical has not conducted 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 incurred 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. 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 2020 $ 13,311 $ — $ 334 $ 2,288 $ — 2021 9,866 — 334 1,962 — 2022 24,100 — 483 1,610 — 2023 24,743 — 322 929 — 2024 26,332 — 213 663 — 2025 and thereafter 242,941 350,557 7,387 13,813 — Indefinite 62,618 — — — 9,265 Totals $ 403,911 $ 350,557 $ 9,073 $ 21,264 $ 9,265 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, 2019 and 2018 . Management reevaluates the positive and negative evidence at each reporting period. The Company’s valuation allowance increased by approximately $95.4 million for year ended December 31, 2019 , which includes a full valuation allowance against the acquired deferred tax assets from the Merger. For the year ended December 31, 2018 , the valuation allowance increased by $3.5 million . The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes that it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcome of examinations by tax authorities in determining the adequacy of its provision for income taxes. 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, 2019 . 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 at December 31, 2019 and 2018 , and has not recognized interest and/or penalties in its statements of operations for the years ended December 31, 2019 and 2018 . As of December 31, 2019 , 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, 2016 . 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. |
SELECTED QUARTERLY FINANCIAL DA
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) | SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) This information has been prepared on a basis consistent with that of the audited consolidated financial statements. We believe that all necessary adjustments, consisting of normal recurring accruals and adjustments, have been included to present fairly the quarterly financial data. The results of historical periods are not necessarily indicative of the results of operations for any future period. The table below summarizes the Company’s unaudited consolidated quarterly operating results for the year ended December 31, 2019: For the Quarters Ended March June September December (unaudited, in thousands, except per share data) Collaboration revenue $ 3,492 $ 2,573 $ 1,183 $ 669 Loss from operations $ (4,593 ) $ (2,979 ) $ (6,055 ) $ (10,841 ) Net loss $ (4,580 ) $ (3,654 ) $ (4,781 ) $ (10,862 ) Net income (loss) attributable to common stockholders $ 5,939 $ (3,817 ) $ (4,863 ) $ (10,862 ) Basic net income (loss) per common share attributable to common stockholders $ 10.08 $ (6.49 ) $ (1.65 ) $ (1.38 ) Diluted net loss per common share attributable to common stockholders $ (2.48 ) $ (6.49 ) $ (1.65 ) $ (1.38 ) The table below summarizes the Company’s unaudited consolidated quarterly operating results for the year ended December 31, 2018: For the Quarters Ended March June September December (unaudited, in thousands, except per share data) Collaboration revenue $ 5,000 $ 373 $ 3,042 $ 2,473 Income (loss) from operations $ 764 $ (3,315 ) $ (2,299 ) $ (3,601 ) Net income (loss) $ 527 $ (3,552 ) $ (2,541 ) $ (3,670 ) Net loss attributable to common stockholders $ (2,713 ) $ (4,417 ) $ (3,507 ) $ (4,535 ) Basic and diluted net loss per common share attributable to common stockholders $ (4.63 ) $ (7.53 ) $ (5.98 ) $ (7.72 ) |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS Private Placement Offerings On February 17, 2020, the Company and 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 agreed to purchase, and the Company agreed to sell, upon the terms and subject conditions stated therein (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 the February 28, 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 off of 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. The Company agreed with Lincoln Park that it will not enter into any “variable rate” transactions with any third party 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. Actual sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The Company expects that any net proceeds received by the Company from such sales to Lincoln Park will be used for research and development, working capital and general corporate purposes. 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. Amended and Restated License Agreement with Bodor On February 17, 2020, the Company, Brickell Subsidiary, Inc., 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 Bodor license agreement, dated December 15, 2012, entered into between the Company 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 technology 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. The Company is required to further pay Bodor (i) a specified percentage of all royalties received from covered sales in territories pursuant to the Kaken Agreement; (ii) a modified percentage of any sublicensing income the Company receives pursuant to the Kaken Agreement; (iii) a low single-digit royalty related to a newly filed provisional patent application anywhere outside of the territories in the Kaken Agreement by the Company; and (iv) a specified cash amount following the occurrence of certain new milestone events. The Company also agreed to issue to Bodor shares of its common stock upon the occurrence of certain new milestone events, as further described in the Amended and Restated License Agreement. The Amended and Restated License Agreement also imposes various diligence, sublicensing, milestone, royalty, notice, disbursement, dispute resolution and other obligations and restrictions on the Company. Consistent with the original license agreement, if the Company were to fail to comply with its material obligations under the Amended and Restated License Agreement, and if the Company does not successfully cure such alleged breach, then Bodor maintains the right to terminate the license, subject to the dispute procedures as set forth therein, in which event the Company might not be able to develop or market sofpironium bromide for its licensed use, if such termination is deemed valid. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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 have been prepared in accordance with accounting principles generally accepted in the United States of America (“ US GAAP ”) and 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 US 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. |
Concentration 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 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 |
Long-Lived Assets | Long-Lived Assets The Company’s intangible assets are considered indefinite-lived and are not amortized, but are tested for impairment on an annual basis, as well as between annual tests if changes in circumstances indicate a reduction in the fair value of the in-process research and development (“IPR&D”) projects below their respective carrying amounts. In connection with any impairment assessment, the fair value of the intangible assets as of the date of assessment is compared to the carrying value of the intangible asset. If and when development is complete, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives. |
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 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 tables set forth the fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): December 31, 2019 Level 1 Level 2 Level 3 Assets: Money market funds $ 7,232 $ — $ — U.S. treasuries 4,497 — — Total $ 11,729 $ — $ — December 31, 2018 Level 1 Level 2 Level 3 Assets: Money market funds $ 8,067 $ — $ — Liabilities: Redeemable convertible preferred stock warrant liability $ — $ — $ 242 Contingent consideration — — 145 Total $ — $ — $ 387 The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments as follows (in thousands): Derivative Common Redeemable Contingent Fair value as of December 31, 2018 $ — $ — $ 242 $ 145 Fair value of financial instruments issued 1,442 1,492 — — Change in fair value 11 17 (240 ) (145 ) Reclassification to equity (1,453 ) (1,509 ) (2 ) — Fair value as of December 31, 2019 $ — $ — $ — $ — 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 has designated its investments in U.S. treasury securities as available-for-sale securities and accounts for them at their respective fair values. The securities are classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Securities that are 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 that are 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. As of December 31, 2019 , the Company’s available-for-sale securities had an amortized cost of $4.5 million , fair value of $4.5 million , and an unrealized gain of $3 thousand . Because the securities were acquired in August 2019 in connection with the Merger, there were no related balances as of December 31, 2018 . Contingent Consideration— These amounts represented future payments in conjunction with various business combinations related to the acquisition of certain early-stage pipeline assets. These assets were impaired during the year ended December 31, 2019 , and therefore, the likelihood of future development and regulatory milestones and other potential future payments related to these assets was considered to be remote. The Company evaluated its estimates of the fair value of contingent consideration on a quarterly basis. The fair value of the contingent consideration was determined with the assistance of a third-party valuation firm applying the income approach. This approach estimated the fair value of the contingent consideration related to the achievement of future development and regulatory milestones by assigning an achievement probability and date of expected completion to each potential milestone and discounting the associated cash payment to its present value using a risk-adjusted rate of return. The probability of success of each milestone assumed that the prerequisite developmental milestones were successfully completed and was based on the asset’s current stage of development and anticipated regulatory requirements. The probability of success for each milestone was determined by multiplying the preceding probabilities of success. At December 31, 2018 , the unobservable inputs (Level 3 of the fair value hierarchy) to the valuation models that have the most significant effect on the fair value of the Company’s contingent consideration were the probabilities that certain in-process development projects would meet specified development milestones, including ultimate approval by the FDA, with individual cumulative probabilities ranging from 2.1% to 20.9% . Other unobservable inputs used in this approach include risk-adjusted discount rates ranging from 15.5% to 27.1% and estimates of the timing of the achievement of the various product development, regulatory approval, and sales milestones. Redeemable Convertible Preferred Stock Warrant Liability —These amounts represented potential future obligations to transfer assets to the holders at a future date. The Company remeasured these warrants to current fair value at each balance sheet date, and any change in fair value was recognized as a change in fair value of warrant liability in the consolidated statements of operations . The Company estimated the fair value of these warrants at December 31, 2018 using the Black-Scholes option-pricing model (Level 3 of the fair value hierarchy table). These warrants converted from warrants exercisable for redeemable convertible preferred stock to common stock in August 2019 in connection with the Merger (see further discussion in “ Note 6 . Note Payable ”). Inputs used to determine estimated fair value of the warrant liabilities included the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends, and the expected volatility of the underlying stock. The most significant unobservable inputs used in the fair value measurement of the convertible preferred stock warrant liability were the fair value of the underlying stock at the valuation date and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term resulted in a directionally similar impact to the fair value measurement. The fair value of the outstanding warrants was remeasured for the following period end using the Black-Scholes option-pricing model with the following assumptions: 2018 Expected term (in years) 7.1 Expected volatility 30.00 % Risk free interest rate 2.59 % Expected dividend yield — % The fair value of the shares of the convertible preferred stock underlying the preferred stock warrants was historically determined with the assistance of a third-party valuation firm. Because there had been no public market for the Company’s convertible preferred stock, the third-party valuation firm determined fair value of the convertible preferred stock at each balance sheet date by considering a number of objective and subjective factors, including valuation of comparable companies, sales of convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock, and general and industry specific economic outlook, among other factors. Remaining Term. The Company derived the expected term based on the time from the balance sheet date until the preferred stock warrant’s expiration date. Expected Volatility. Since the Company was previously a private entity prior to the Merger with no historical data regarding the volatility of its preferred stock, the expected volatility used was based on volatility of a group of similar entities. In evaluating similarity, the Company considered factors such as industry, stage of life cycle, and size. Risk-free Interest Rate . The risk-free interest rate was based on U.S. Treasury zero-coupon issues with remaining terms similar to the expected term of the warrants. Expected Dividend Rate . The Company has never paid any dividends and does not plan to pay dividends in the foreseeable future and, therefore, used an expected dividend rate of zero in the valuation model. Derivative Liability— These amounts represented potential future obligations to transfer assets to the holders at a future date. The fair value of the derivative liability has historically been determined with the assistance of a third-party valuation firm (Level 3 of the fair value hierarchy table) (see further discussion in “ Note 5 Convertible Promissory Notes ”). At the inception of the liability, there was no public market for the Company’s common stock, and a third-party valuation firm determined fair value of the stock by considering a number of objective and subjective factors, including valuation of comparable companies, sales of common stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock, and general and industry specific economic outlook, among other factors. The derivative liability was marked-to-market each measurement period and any change in fair value was recorded in the consolidated statements of operations . In August 2019, in connection with the Merger, the derivative liability was reclassified to equity in the consolidated balance sheet (see further discussion in “ Note 5 . Convertible Promissory Notes ”). Common Stock Warrant Liability —These amounts represented potential future obligations to transfer assets to the holders at a future date. The fair value of the warrants was historically determined with the assistance of a third-party valuation firm (Level 3 of the fair value hierarchy table) (see further discussion in Note 5 ). At the inception of the liability, there was no public market for the Company’s common stock, and a third-party valuation firm determined fair value of the stock by considering a number of objective and subjective factors, including valuation of comparable companies, sales of common stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock, and general and industry specific economic outlook, among other factors. The warrant liability was remeasured to fair value at each balance sheet date, and any change in fair value was recognized as a change in fair value of warrant liability in the consolidated statements of operations . The Company estimated the fair value of these warrants using the Black-Scholes option-pricing model. In August 2019, in connection with the Merger, the warrant liability was reclassified to equity in the consolidated balance sheet (see further discussion in “ Note 5 . Convertible Promissory Notes ”). Inputs used to determine estimated fair value of the warrant liabilities included the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends, and the expected volatility of the underlying stock. The most significant unobservable inputs used in the fair value measurement of the warrant liability were the fair value of the underlying stock at the valuation date and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term resulted in a directionally similar impact to the fair value measurement. |
Leases | Leases On January 1, 2019, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 842, Leases (“ASC 842”), using the modified retrospective method for all lease arrangements at the beginning of the period of adoption. Results for reporting periods beginning January 1, 2019 are presented under ASC 842, while prior period amounts were not adjusted and continue to be presented in accordance with the Company’s historical accounting under ASC Topic 840, Leases. ASC 842 had an impact on the Company’s consolidated balance sheets but did not have an impact on the Company’s net loss. 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 . |
Redeemable Convertible Preferred Stock and Warrants | Redeemable Convertible Preferred Stock Redeemable convertible preferred stock was classified as a mezzanine instrument outside of the Company’s capital accounts. Accretion of redeemable convertible preferred stock included the greater of an adjustment to fair market value or the accrual of dividends on and accretion of issuance costs of the Company’s redeemable convertible preferred stock. The carrying values of the redeemable convertible preferred stock were increased or reduced by periodic accretion or reduction to their respective redemption values from the date of issuance to August 31, 2019, the date that all outstanding shares of redeemable convertible preferred stock converted into shares of common stock. The carrying value adjustments were recorded as charges against additional paid-in capital balance. Preferred stock issuance costs represent costs related to the Company’s issuance of redeemable convertible preferred stock. These amounts were included as a reduction of redeemable convertible preferred stock and were amortized over the estimated redemption period until its conversion to common stock in August 2019. For the year ended December 31, 2019 and 2018 , amortization of preferred stock issuance costs amounted to approximately $0.1 million and $40 thousand , respectively. Redeemable Convertible Preferred Stock Warrants The Company accounted for warrants to purchase shares of its redeemable convertible preferred stock as liabilities at their estimated fair value because the underlying shares were redeemable, which obligated the Company to transfer assets to the holders at a future date. The warrants were subject to remeasurement to fair value at each balance sheet date, and any fair value adjustments were recognized as change in fair value of redeemable convertible preferred stock warrant liability in the consolidated statements of operations . The Company continued to adjust the liability for changes in fair value until the conversion of the redeemable convertible preferred stock into common stock in August 2019. At that time, the redeemable convertible preferred stock warrant liability was adjusted to fair value in the consolidated statements of operations with the final fair value reclassified to equity. |
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’s drug candidates have not been approved for sale by the FDA or any other country’s regulatory authority, and the Company has not generated or recognized any revenue from the sale of products. In March 2015, the Company entered into a license, development, and commercialization agreement (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 (formerly BBI-4000), 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 and, until such time, if any, as Kaken elects to establish its own source of supply of drug product, Kaken can purchase product supply from the Company to perform all non-clinical studies, and Phase 1 and Phase 2 clinical trials in Japan at cost. Kaken is 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 United States. 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 fees were representative of this type of a 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, adjust the measure of performance and related revenue recognition on a prospective basis. Under 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. 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 is contingent upon success in future clinical trials and regulatory approvals, each of which is uncertain at this time. The Company will re-evaluate 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 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 it does 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. Under Topic 606, the entire transaction price of $11.0 million was allocated to the license performance obligation. The license was deemed to be delivered in 2015 in connection with the execution of the Kaken Agreement and upon transfer of the underlying intellectual property the performance obligation was fully satisfied. As a result, a cumulative adjustment to reduce deferred revenue and the corresponding sublicensing costs of $2.7 million was recorded upon the adoption of Topic 606 on January 1, 2018. As of December 31, 2019 , the Company does not have a deferred revenue or deferred sublicensing costs balance related to the upfront fee on the consolidated balance sheet . In May 2018, the Company entered into an amendment to the Kaken Agreement (as further amended, “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 NDA 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 these under the provisions of Topic 606. This Kaken R&D Payment will be initially recognized using an input method over the average estimated performance period of 1.45 years 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. Consequently, during the year ended December 31, 2019 and 2018, the Company recognized revenue of $7.9 million and $5.9 million , respectively, related to the Kaken R&D Payment. As of December 31, 2019 and 2018, the Company had a deferred revenue balance related to the Kaken R&D Payment of $1.8 million and $9.7 million , respectively, which is recorded in deferred revenue, current portion and net of current portion, on the accompanying consolidated balance sheets . 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, adjust 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. In October 2017, the Company entered into an amendment to the Kaken Agreement, pursuant to which, the Company granted Kaken a prepayment option (the “Kaken Option”) on 50% of the Initiation of Phase 3 milestone (the “Phase 3 Milestone”). The Kaken Option was exercisable by Kaken within 25 business days of receipt of the BBI-4000-CL-203 study topline results. In December 2017, Kaken exercised the Kaken Option and paid the Company $5.0 million (the “Kaken Option Payment”). Upon receipt of the non-refundable Kaken Option Payment, the Company provided Kaken the right to negotiate an exclusive license to develop, manufacture and commercialize each of the Company’s other product candidates in Japan (“ROFN Agreement”). Under the ROFN Agreement, following the completion of any Initial Proof of Concept Clinical Trial (“Initial POC”) for the Company’s other product candidates, the Company must provide Kaken with certain information relating to the results of the clinical trial (“Initial POC Package”). The ROFN Agreement is exercisable by Kaken within 30 days of receipt of the Initial POC Package. In December 2017, the Company recognized collaboration revenue related to the Kaken Agreement of $5.0 million , in connection with the Kaken Option. Additionally, the Company recognized sublicensing costs of $1.0 million , which are included in general and administrative expenses. The Kaken Agreement was further amended in March 2018 to accelerate payment of the Phase 3 Milestone. The Phase 3 Milestone was modified to be due upon the successful completion of the End of Phase 2 Meeting with the PMDA by Kaken on March 8, 2018, as determined by Kaken in its reasonable discretion (the “Third Milestone”). In March 2018, Kaken triggered the Third Milestone and paid the Company $5.0 million (the “Third Milestone Payment”). Upon receipt of the non-refundable Third Milestone Payment, the ROFN Agreement was amended (the “Amended ROFN Agreement”) to grant an additional option to exercise upon completion of a Subsequent Clinical Trial (first clinical trial after the Initial POC) for the Company’s other product candidates. The Company has determined that the ROFN Agreement is not a material right and has not allocated transaction price to this provision. As of December 31, 2019 , Kaken has not exercised the Amended ROFN Agreement. In March 2018, the Company recognized collaboration revenue related to the Kaken Agreement of $5.0 million in connection with the Third Milestone. Additionally, the Company recognized sublicensing costs of $1.0 million , which are included in general and administrative expenses. 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 recognized revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from any collaborative arrangement. Under collaborative arrangements, the Company has been reimbursed for a portion of the Company’s research and development expenses, including costs of drug supplies. When the research and development services are performed under a reimbursement or cost sharing model with a collaboration partner, the Company records these reimbursements as a reduction of research and development expense in the Company’s consolidated statements of operations . |
Net Income (Loss) per Common Share | Net Loss per Common Share Basic and diluted net loss per common share is computed by dividing net 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 earnings 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 and warrants, using the treasury stock method, and redeemable convertible preferred stock, 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 purchased from the exercise of stock options or 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. |
New Accounting Pronouncements | In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which amends certain disclosure requirements over Level 1, Level 2, and Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2018-13, but does not anticipate it will have a material impact on its disclosures. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). ASU 2016-02 is aimed at making leasing activities more transparent and comparable and requires substantially all leases be recognized by lessees on their balance sheets as a right-of-use asset and corresponding lease liability, including leases currently accounted for as operating leases. The Company adopted ASU 2016-02 on January 1, 2019 using the modified retrospective approach. The adoption did not have a material impact on the Company’s consolidated statements of operations . The new standard has required the Company to establish liabilities and corresponding right-of-use assets on its consolidated balance sheet for operating leases of $0.2 million |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Net Assets Acquired | The following table summarizes the net assets acquired based on their estimated fair values immediately prior to the Merger (in thousands): Cash and cash equivalents $ 13,017 Marketable securities 23,959 Prepaid expenses and other current assets 1,474 Accrued liabilities (2,357 ) Net acquired tangible assets $ 36,093 |
Fair Value Measurements, Recurring and Nonrecurring | The following tables set forth the fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): December 31, 2019 Level 1 Level 2 Level 3 Assets: Money market funds $ 7,232 $ — $ — U.S. treasuries 4,497 — — Total $ 11,729 $ — $ — December 31, 2018 Level 1 Level 2 Level 3 Assets: Money market funds $ 8,067 $ — $ — Liabilities: Redeemable convertible preferred stock warrant liability $ — $ — $ 242 Contingent consideration — — 145 Total $ — $ — $ 387 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments as follows (in thousands): Derivative Common Redeemable Contingent Fair value as of December 31, 2018 $ — $ — $ 242 $ 145 Fair value of financial instruments issued 1,442 1,492 — — Change in fair value 11 17 (240 ) (145 ) Reclassification to equity (1,453 ) (1,509 ) (2 ) — Fair value as of December 31, 2019 $ — $ — $ — $ — |
Fair Value Measurement Inputs and Valuation Techniques | The fair value of the outstanding warrants was remeasured for the following period end using the Black-Scholes option-pricing model with the following assumptions: 2018 Expected term (in years) 7.1 Expected volatility 30.00 % Risk free interest rate 2.59 % Expected dividend yield — % |
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 2019 2018 Warrants to purchase common stock 720,982 55,344 Options to purchase common stock 525,665 376,299 Redeemable convertible preferred stock (as converted into common stock) — 1,256,466 Warrants to purchase redeemable convertible preferred stock (as converted into common stock) — 9,005 Total 1,246,647 1,697,114 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. No revenue from sales of product has been generated since inception, and all tangible assets are held in the United States. |
RECENT ACCOUNTING PRONOUNCEME_2
RECENT ACCOUNTING PRONOUNCEMENTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | The impact on the consolidated balance sheets as of January 1, 2019 was as follows (in thousands): Balance Sheet Topic 840 January 1, 2019 Topic 842 January 1, 2019 Impact of Operating lease right-of-use asset $ — $ 219 $ 219 Lease liability, current portion — (68 ) (68 ) Lease liability, net of current portion — (151 ) (151 ) |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2019 2018 Accrued contracted research and development services $ 4,532 $ 847 Accrued professional fees 1,788 1,269 Accrued compensation 59 569 Accrued note payable issuance costs — 587 Total $ 6,379 $ 3,272 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 and the effect such obligations are expected to have on the liquidity and cash flows in future periods (in thousands): Less than 1 year $ 84 1-3 years 77 3-5 years — More than 5 years — Imputed interest (10 ) Total $ 151 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | A summary of stock option activity under the 2009 Plan and the Vical Plan is as follows, as converted associated with stock split and conversion: Shares Weighted Price Total Intrinsic Weighted Average (In Years) Outstanding at December 31, 2018 696,842 $ 13.21 Acquired under Vical Plan 184,087 $ 75.98 Granted 1,088,260 $ 4.67 Exercised — $ — Forfeited or expired (175,587 ) $ 28.22 Outstanding at December 31, 2019 1,793,602 $ 13.00 $ 4,971 8.49 Options vested and exercisable at December 31, 2019 525,665 $ 28.41 $ 73,878 5.97 |
Schedule of Share-Based Compensation Expense | Share-based Compensation Expense Total stock-based compensation expense related to stock options granted under the 2009 Plan and the Vical Plan was allocated as follows (in thousands): Year Ended 2019 2018 Research and development $ 349 $ 340 General and administrative 1,183 371 Total stock-based compensation expense $ 1,532 $ 711 |
Schedule of Valuation Assumptions | The assumptions used to calculate the fair value of stock options granted to non-employees under the 2009 Plan are as follows, presented on a weighted average basis: Year Ended 2019 2018 Expected term (in years) 6.02 9.96 Expected volatility 82.82 % 86.17 % Risk free interest rate 1.49 % 2.69 % Expected dividend yield — % — % The assumptions used to calculate the fair value of stock options granted to employees and non-employee directors under the 2009 Plan are as follows, presented on a weighted average basis: Year Ended 2019 2018 Expected term (in years) 6.1 6.1 Expected volatility 83.22 % 85.43 % Risk free interest rate 1.44 % 2.77 % Expected dividend yield — % — % |
CAPITAL STOCK (Tables)
CAPITAL STOCK (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Reserved Authorized Shares of Common Stock | The Company has reserved authorized shares of common stock for future issuance at December 31, 2019 as follows: December 31, 2019 Common stock options outstanding 1,793,602 Common stock warrants 720,982 Options available for grant under the Vical Plan 86,584 Options available for grant under the 2009 Plan 59,011 Total 2,660,179 |
Summary of Preferred Stock | Redeemable convertible preferred stock consisted of the following prior to the conversion on August 31, 2019 (in thousands, except share data): Preferred Preferred Par Carrying Common Series A 1,162,505 401,309 $ 4 $ 12,164 401,309 Series B 882,216 286,151 3 10,084 286,151 Series C 869,565 256,583 3 11,630 256,583 Series C-1 1,531,942 312,423 3 14,138 312,423 4,446,228 1,256,466 $ 13 $ 48,016 1,256,466 Redeemable convertible preferred stock consisted of the following as of December 31, 2018 (in thousands, except share data): Preferred Preferred Par Carrying Common Series A 1,162,505 401,309 $ 4 $ 16,098 401,309 Series B 882,216 286,151 3 13,011 286,151 Series C 869,565 256,583 3 13,018 256,583 Series C-1 1,268,657 312,423 3 16,163 312,423 4,182,943 1,256,466 $ 13 $ 58,290 1,256,466 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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 2019 2018 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 3.16 3.71 Research and development tax credits 3.25 8.77 Permanent differences and other (2.51 ) 2.36 Transaction costs (1.88 ) — Stock-based compensation (1.02 ) — Change in tax rate 0.02 1.80 Change in deferred tax asset valuation allowance (22.02 ) (37.64 ) 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 2019 2018 Net operating loss carryforwards $ 82,703 $ 8,918 Research and development credit 15,509 3,207 Depreciable assets 10,443 — Accrued expenses 719 — Deferred revenue 449 2,040 Net book value of intangible assets 415 75 Stock-based compensation 332 520 Other 63 514 Net deferred tax asset 110,633 15,274 Less: valuation allowance (110,633 ) (15,274 ) Net deferred tax assets $ — $ — |
Summary of Federal and State Carryforwards and Credits Maturity | 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 2020 $ 13,311 $ — $ 334 $ 2,288 $ — 2021 9,866 — 334 1,962 — 2022 24,100 — 483 1,610 — 2023 24,743 — 322 929 — 2024 26,332 — 213 663 — 2025 and thereafter 242,941 350,557 7,387 13,813 — Indefinite 62,618 — — — 9,265 Totals $ 403,911 $ 350,557 $ 9,073 $ 21,264 $ 9,265 |
SELECTED QUARTERLY FINANCIAL _2
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The table below summarizes the Company’s unaudited consolidated quarterly operating results for the year ended December 31, 2019: For the Quarters Ended March June September December (unaudited, in thousands, except per share data) Collaboration revenue $ 3,492 $ 2,573 $ 1,183 $ 669 Loss from operations $ (4,593 ) $ (2,979 ) $ (6,055 ) $ (10,841 ) Net loss $ (4,580 ) $ (3,654 ) $ (4,781 ) $ (10,862 ) Net income (loss) attributable to common stockholders $ 5,939 $ (3,817 ) $ (4,863 ) $ (10,862 ) Basic net income (loss) per common share attributable to common stockholders $ 10.08 $ (6.49 ) $ (1.65 ) $ (1.38 ) Diluted net loss per common share attributable to common stockholders $ (2.48 ) $ (6.49 ) $ (1.65 ) $ (1.38 ) The table below summarizes the Company’s unaudited consolidated quarterly operating results for the year ended December 31, 2018: For the Quarters Ended March June September December (unaudited, in thousands, except per share data) Collaboration revenue $ 5,000 $ 373 $ 3,042 $ 2,473 Income (loss) from operations $ 764 $ (3,315 ) $ (2,299 ) $ (3,601 ) Net income (loss) $ 527 $ (3,552 ) $ (2,541 ) $ (3,670 ) Net loss attributable to common stockholders $ (2,713 ) $ (4,417 ) $ (3,507 ) $ (4,535 ) Basic and diluted net loss per common share attributable to common stockholders $ (4.63 ) $ (7.53 ) $ (5.98 ) $ (7.72 ) |
ORGANIZATION AND NATURE OF OP_2
ORGANIZATION AND NATURE OF OPERATIONS - Narrative (Details) $ / shares in Units, $ in Thousands | Aug. 31, 2019$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017shares |
Business Acquisition [Line Items] | ||||||||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Common stock, shares outstanding (in shares) | shares | 7,810,680 | 8,480,968 | 589,001 | 8,480,968 | 589,001 | |||||||
Common stock, shares issued (in shares) | shares | 7,810,680 | 8,480,968 | 589,001 | 8,480,968 | 589,001 | |||||||
Net loss | $ (10,862) | $ (4,781) | $ (3,654) | $ (4,580) | $ (3,670) | $ (2,541) | $ (3,552) | $ 527 | $ (23,877) | $ (9,236) | ||
Net cash used in operating activities | (35,981) | 3,967 | ||||||||||
Cash, cash equivalents and marketable securities | 11,700 | 11,700 | ||||||||||
Accumulated deficit | $ (84,980) | $ (71,624) | $ (84,980) | $ (71,624) | ||||||||
Common Stock | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Common stock, shares outstanding (in shares) | shares | 8,480,968 | 589,001 | 8,480,968 | 589,001 | 585,262 | |||||||
Brickell Former Securityholders | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Percent of shares owned | 57.00% | |||||||||||
Vical Former Securityholders | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Percent of shares owned | 43.00% | |||||||||||
Vical | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | |||||||||||
Reverse stock split ratio | 0.1429 | |||||||||||
Series A, B, C & C-1 Redeemable Convertible Preferred Stock | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Conversion ratio | 1 | |||||||||||
Common Stock | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Conversion ratio | 2.4165 | 2.4165 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Merger Narrative (Details) $ / shares in Units, $ in Thousands | Aug. 31, 2019USD ($)shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2019USD ($)segmentshares | Dec. 31, 2018USD ($) | Jun. 02, 2018$ / sharesshares |
Business Acquisition [Line Items] | |||||
Number of operating segments | segment | 1 | ||||
Proceeds from the exercise of warrants | $ | $ 47 | $ 0 | |||
Vical Warrants | |||||
Business Acquisition [Line Items] | |||||
Warrants converted (in shares) | shares | 891,582 | ||||
Exercise price (in usd per share) | $ / shares | $ 0.07 | ||||
Warrants exercised (in shares) | shares | 670,288 | 670,288 | |||
Proceeds from the exercise of warrants | $ | $ 47 | ||||
Vical | |||||
Business Acquisition [Line Items] | |||||
Common stock issued in recapitalization (in shares) | shares | 3,367,988 | ||||
Net acquired tangible assets | $ | $ 36,093 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Net Assets Acquired (Details) - Vical $ in Thousands | Aug. 31, 2019USD ($) |
Business Acquisition [Line Items] | |
Cash and cash equivalents | $ 13,017 |
Marketable securities | 23,959 |
Prepaid expenses and other current assets | 1,474 |
Accrued liabilities | (2,357) |
Net acquired tangible assets | $ 36,093 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment and Long-Lived Assets Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation expense | $ 28 | $ 49 |
Impairment expense | $ 441 | $ 0 |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Useful life | 3 years | |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Useful life | 5 years | |
Contingent Consideration Liabilities | ||
Property, Plant and Equipment [Line Items] | ||
Change in fair value | $ (100) |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value of Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Assets: | |||
U.S. treasuries | $ 4,500 | ||
Liabilities: | |||
Warrant liability | 0 | $ 1,500 | $ 242 |
Fair Value, Recurring | Level 1 | |||
Assets: | |||
Money market funds | 7,232 | 8,067 | |
U.S. treasuries | 4,497 | ||
Total | 11,729 | ||
Liabilities: | |||
Warrant liability | 0 | ||
Contingent consideration | 0 | ||
Total | 0 | ||
Fair Value, Recurring | Level 2 | |||
Assets: | |||
Money market funds | 0 | 0 | |
U.S. treasuries | 0 | ||
Total | 0 | ||
Liabilities: | |||
Warrant liability | 0 | ||
Contingent consideration | 0 | ||
Total | 0 | ||
Fair Value, Recurring | Level 3 | |||
Assets: | |||
Money market funds | 0 | 0 | |
U.S. treasuries | 0 | ||
Total | $ 0 | ||
Liabilities: | |||
Warrant liability | 242 | ||
Contingent consideration | 145 | ||
Total | $ 387 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Reconciliation of Level 3 Financial Instruments (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Derivative Liability | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | $ 0 |
Fair value of financial instruments issued | 1,442 |
Change in fair value | 11 |
Reclassification to equity | (1,453) |
Ending Balance | 0 |
Common Stock Warrant Liability | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | 0 |
Fair value of financial instruments issued | 1,492 |
Change in fair value | 17 |
Reclassification to equity | (1,509) |
Ending Balance | 0 |
Redeemable Convertible Preferred Stock Warrant Liability | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | 242 |
Fair value of financial instruments issued | 0 |
Change in fair value | (240) |
Reclassification to equity | (2) |
Ending Balance | 0 |
Contingent Consideration Liabilities | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | 145 |
Fair value of financial instruments issued | 0 |
Change in fair value | (100) |
Reclassification to equity | 0 |
Ending Balance | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value Measurements Narrative (Details) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Marketable securities, available-for-sale, amortized cost | $ 4,500,000 | $ 0 |
U.S. treasuries | 4,500,000 | |
Marketable securities, available-for-sale, accumulated unrealized gain | $ 3,000 | |
Minimum | Individual cumulative achievement probabilities | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.021 | |
Minimum | Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.155 | |
Maximum | Individual cumulative achievement probabilities | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.209 | |
Maximum | Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.271 |
SUMMARY OF SIGNIFICANT ACCOU_10
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value Measurement Inputs (Details) | Dec. 31, 2018 |
Expected term (in years) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value measurement input | 7.1 |
Expected volatility | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value measurement input | 0.3000 |
Risk free interest rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value measurement input | 0.0259 |
Expected dividend yield | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value measurement input | 0 |
SUMMARY OF SIGNIFICANT ACCOU_11
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Redeemable Convertible Preferred Stock Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Temporary Equity [Line Items] | ||
Amortization of discounts and financing costs | $ 1,575 | $ 489 |
Series A, B, C & C-1 Redeemable Convertible Preferred Stock | ||
Temporary Equity [Line Items] | ||
Amortization of discounts and financing costs | $ 100 | $ 40 |
SUMMARY OF SIGNIFICANT ACCOU_12
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||||
May 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Oct. 31, 2017 | Mar. 31, 2015 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Revenue recognized | $ 669 | $ 1,183 | $ 2,573 | $ 3,492 | $ 2,473 | $ 3,042 | $ 373 | $ 5,000 | $ 7,917 | $ 10,888 | ||||||
Deferred revenue, current portion | 1,795 | 8,117 | 1,795 | 8,117 | ||||||||||||
General and administrative | $ 12,171 | 6,379 | ||||||||||||||
Collaborative Arrangement | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Non-refundable upfront fees | $ 15,600 | $ 11,000 | ||||||||||||||
Development milestone payments | 10,000 | |||||||||||||||
Commercialization milestone payments | $ 30,000 | |||||||||||||||
Expected performance period | 1 year 5 months 12 days | |||||||||||||||
Basis point reduction | 1.50% | |||||||||||||||
Revenue recognized | $ 5,000 | 5,000 | $ 7,900 | 5,900 | ||||||||||||
Deferred revenue, current portion | $ 1,800 | $ 9,700 | $ 1,800 | $ 9,700 | ||||||||||||
Prepayment option percent | 50.00% | |||||||||||||||
Prepayment amount | $ 5,000 | |||||||||||||||
Milestone payment received | $ 5,000 | |||||||||||||||
Accounting Standards Update 2014-09 | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Effect of adoption of Topic 606 | $ 2,734 | |||||||||||||||
Sublicensing Costs | Collaborative Arrangement | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
General and administrative | $ 1,000 | $ 1,000 |
SUMMARY OF SIGNIFICANT ACCOU_13
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Common Shares Excluded from EPS Calculations (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 1,246,647 | 1,697,114 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 720,982 | 55,344 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 525,665 | 376,299 |
Redeemable convertible preferred stock (as converted into common stock) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 0 | 1,256,466 |
Warrants to purchase redeemable convertible preferred stock (as converted into common stock) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 0 | 9,005 |
RECENT ACCOUNTING PRONOUNCEME_3
RECENT ACCOUNTING PRONOUNCEMENTS - Narrative (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease right-of-use asset | $ 159 | |
Accounting Standards Update 2016-02 [Member] | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease right-of-use asset | $ 219 |
RECENT ACCOUNTING PRONOUNCEME_4
RECENT ACCOUNTING PRONOUNCEMENTS - Effects of Topic 842 (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease right-of-use asset | $ 159 | |
Lease liability, current portion | (78) | |
Lease liability, net of current portion | $ (73) | |
Accounting Standards Update 2016-02 [Member] | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease right-of-use asset | $ 219 | |
Lease liability, current portion | (68) | |
Lease liability, net of current portion | (151) | |
Impact of Adoption | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease right-of-use asset | 219 | |
Lease liability, current portion | (68) | |
Lease liability, net of current portion | $ (151) |
ACCRUED LIABILITIES - Summary o
ACCRUED LIABILITIES - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accrued contracted research and development services | $ 4,532 | $ 847 |
Accrued professional fees | 1,788 | 1,269 |
Accrued compensation | 59 | 569 |
Accrued note payable issuance costs | 0 | 587 |
Accrued liabilities | $ 6,379 | $ 3,272 |
CONVERTIBLE PROMISSORY NOTES -
CONVERTIBLE PROMISSORY NOTES - Narrative (Details) - USD ($) | Aug. 31, 2019 | Mar. 31, 2019 | Aug. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Short-term Debt [Line Items] | |||||
Proceeds from issuance of convertible promissory notes | $ 7,397,000 | $ 0 | |||
Warrant liability | $ 1,500,000 | 0 | 242,000 | ||
Derivative liability, fair value | $ 1,400,000 | ||||
Gain on extinguishment | 2,318,000 | $ 0 | |||
Convertible Promissory Notes | |||||
Short-term Debt [Line Items] | |||||
Stated rate | 12.00% | ||||
Debt term | 1 year | ||||
Conversion price (in usd per share) | $ 7.54 | $ 31.05 | $ 7.54 | ||
Qualified financing threshold | $ 15,000,000 | ||||
Conversion price as percent of price paid per share | 80.00% | ||||
Share price threshold (in usd per share) | $ 38.82 | ||||
Proceeds from issuance of convertible promissory notes | $ 7,400,000 | ||||
Coverage percent | 50.00% | ||||
Stock issuable upon warrants (in shares) | 490,683 | ||||
Term of warrants | 5 years | ||||
Exercise price (in usd per share) | $ 42.70 | $ 10.36 | $ 42.70 | ||
Premium percentage on effective price | 10.00% | ||||
Interest expense | (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 | Jun. 02, 2018 | Feb. 18, 2016 | Jul. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Jul. 31, 2018 |
Debt Instrument [Line Items] | |||||||
Facility fees | $ 0 | $ 50,000 | |||||
Payments of principal of note payable | $ (2,600,000) | $ (4,808,000) | $ (1,282,000) | ||||
Payment of associated accrued interest and aggregate end-of-term payment | $ 600,000 | ||||||
Note Payable | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | $ 7,500,000 | ||||||
End of term payment rate | 4.50% | ||||||
Applicable percent of aggregate unfunded term loan commitments | 50.00% | ||||||
Increase in termination payment | $ 100,000 | ||||||
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 | ||||||
Warrant liability | $ 300,000 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) | 12 Months Ended | |
Dec. 31, 2019USD ($)ft²renewal_term | Dec. 31, 2018USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | ||
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 asset | $ 100,000 | |
Remaining lease term | 1 year 9 months 18 days | |
Lease expense | $ 100,000 | $ 100,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Schedule of Contractual Obligations (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Less than 1 year | $ 84 |
1-3 years | 77 |
3-5 years | 0 |
More than 5 years | 0 |
Imputed interest | (10) |
Total | $ 151 |
STOCK-BASED COMPENSATION - Narr
STOCK-BASED COMPENSATION - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized share-based compensation expense | $ 5.7 | |
Unrecognized share-based compensation expense, period for recognition | 3 years 3 months 25 days | |
Estimated forfeiture rate | 7.00% | |
Options granted (in shares) | 1,088,260 | |
Weighted-average exercise price (in usd per share) | $ 4.67 | |
Vical Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expiration term | 10 years | |
Maximum shares permitted to be granted in a single calendar year (in shares) | 1,300,000 | |
Options | 2009 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares authorized (in shares) | 1,634,655 | |
Shares available for grant (in shares) | 59,011 | |
Options | Vical Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares authorized (in shares) | 413,710 | |
Shares available for grant (in shares) | 86,584 | |
Employee (including Board of Directors) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options granted (in shares) | 982,890 | 252,681 |
Weighted-average grant date fair value (in dollars per share) | $ 3.24 | $ 4.16 |
Weighted-average exercise price (in usd per share) | $ 4.58 | $ 5.68 |
Non-employee (excluding Board of Directors) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options granted (in shares) | 105,370 | 15,188 |
Weighted-average exercise price (in usd per share) | $ 5.53 | $ 5.68 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
Shares | |
Options outstanding (in shares) | shares | 1,793,602 |
Acquired under Vical Plan (in shares) | shares | 184,087 |
Granted (in shares) | shares | 1,088,260 |
Exercised (in shares) | shares | 0 |
Forfeited (in shares) | shares | (175,587) |
Options outstanding (in shares) | shares | 696,842 |
Weighted Average Exercise Price | |
Weighted Average Exercise Price (in usd per share) | $ / shares | $ 13.21 |
Weighted Average Exercise Price, Acquired under Vical Plan (in usd per share) | $ / shares | 75.98 |
Weighted Average Exercise Price, Granted (in usd per share) | $ / shares | 4.67 |
Weighted Average Exercise Price, Exercised (in usd per share) | $ / shares | 0 |
Weighted Average Exercise Price, Forfeited or expired (in usd per share) | $ / shares | 28.22 |
Weighted Average Exercise Price (in usd per share) | $ / shares | $ 13 |
Total Intrinsic Value | |
Intrinsic Value, Outstanding | $ | $ 4,971 |
Intrinsic Value, Options vested and exercisable | $ | $ 73,878 |
Weighted Average Remaining Contractual Life (In Years) | |
Weighted Average Remaining Contractual Life (In Years), Outstanding | 8 years 5 months 26 days |
Weighted Average Remaining Contractual Life (In Years), Options vested and exercisable | 5 years 11 months 19 days |
Options vested and exercisable (in shares) | shares | 525,665 |
Options vested and exercisable (in usd per share) | $ / shares | $ 28.41 |
STOCK-BASED COMPENSATION - Shar
STOCK-BASED COMPENSATION - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,532 | $ 711 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 349 | 340 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,183 | $ 371 |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair Value Assumptions (Details) - Weighted average | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Employee (including Board of Directors) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Expected volatility | 83.22% | 85.43% |
Risk free interest rate | 1.44% | 2.77% |
Expected dividend yield | 0.00% | 0.00% |
Non-employee (excluding Board of Directors) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 7 days | 9 years 11 months 15 days |
Expected volatility | 82.82% | 86.17% |
Risk free interest rate | 1.49% | 2.69% |
Expected dividend yield | 0.00% | 0.00% |
CAPITAL STOCK - Narrative (Deta
CAPITAL STOCK - Narrative (Details) | Dec. 31, 2019 |
Common Stock | |
Class of Stock [Line Items] | |
Conversion ratio | 2.4165 |
CAPITAL STOCK - Reserved Author
CAPITAL STOCK - Reserved Authorized Shares of Common Stock (Details) | Dec. 31, 2019shares |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance | 2,660,179 |
Common stock options outstanding | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance | 1,793,602 |
Common stock warrants | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance | 720,982 |
Vical Plan | Options available for grant under the 2009 Plan | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance | 86,584 |
2009 Plan | Options available for grant under the 2009 Plan | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance | 59,011 |
CAPITAL STOCK - Summary of Pref
CAPITAL STOCK - Summary of Preferred Stock (Details) - USD ($) $ in Thousands | Aug. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2019 |
Temporary Equity [Line Items] | |||
Preferred Shares Authorized (in shares) | 4,446,228 | 4,182,943 | 5,000,000 |
Preferred Shares Issued (in shares) | 1,256,466 | 1,256,466 | 0 |
Preferred Shares Outstanding (in shares) | 1,256,466 | 1,256,466 | 0 |
Par Value | $ 13 | $ 13 | |
Carrying Value | $ 48,016 | $ 58,290 | $ 0 |
Common Stock Issued Upon Conversion (in shares) | 1,256,466 | 1,256,466 | |
Series A | |||
Temporary Equity [Line Items] | |||
Preferred Shares Authorized (in shares) | 1,162,505 | 1,162,505 | |
Preferred Shares Issued (in shares) | 401,309 | 401,309 | |
Preferred Shares Outstanding (in shares) | 401,309 | 401,309 | |
Par Value | $ 4 | $ 4 | |
Carrying Value | $ 12,164 | $ 16,098 | |
Common Stock Issued Upon Conversion (in shares) | 401,309 | 401,309 | |
Series B | |||
Temporary Equity [Line Items] | |||
Preferred Shares Authorized (in shares) | 882,216 | 882,216 | |
Preferred Shares Issued (in shares) | 286,151 | 286,151 | |
Preferred Shares Outstanding (in shares) | 286,151 | 286,151 | |
Par Value | $ 3 | $ 3 | |
Carrying Value | $ 10,084 | $ 13,011 | |
Common Stock Issued Upon Conversion (in shares) | 286,151 | 286,151 | |
Series C | |||
Temporary Equity [Line Items] | |||
Preferred Shares Authorized (in shares) | 869,565 | 869,565 | |
Preferred Shares Issued (in shares) | 256,583 | 256,583 | |
Preferred Shares Outstanding (in shares) | 256,583 | 256,583 | |
Par Value | $ 3 | $ 3 | |
Carrying Value | $ 11,630 | $ 13,018 | |
Common Stock Issued Upon Conversion (in shares) | 256,583 | 256,583 | |
Series C-1 | |||
Temporary Equity [Line Items] | |||
Preferred Shares Authorized (in shares) | 1,531,942 | 1,268,657 | |
Preferred Shares Issued (in shares) | 312,423 | 312,423 | |
Preferred Shares Outstanding (in shares) | 312,423 | 312,423 | |
Par Value | $ 3 | $ 3 | |
Carrying Value | $ 14,138 | $ 16,163 | |
Common Stock Issued Upon Conversion (in shares) | 312,423 | 312,423 |
INCOME TAXES - Effective Income
INCOME TAXES - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
State taxes, net of federal benefit | 3.16% | 3.71% |
Research and development tax credits | 3.25% | 8.77% |
Permanent differences and other | (2.51%) | 2.36% |
Transaction costs | (1.88%) | 0.00% |
Stock-based compensation | (1.02%) | 0.00% |
Change in tax rate | 0.02% | 1.80% |
Change in deferred tax asset valuation allowance | (22.02%) | (37.64%) |
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, 2019 | Dec. 31, 2018 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 82,703 | $ 8,918 |
Research and development credit | 15,509 | 3,207 |
Depreciable assets | 10,443 | 0 |
Accrued expenses | 719 | 0 |
Deferred revenue | 449 | 2,040 |
Net book value of intangible assets | 415 | 75 |
Stock-based compensation | 332 | 520 |
Other | 63 | 514 |
Net deferred tax asset | 110,633 | 15,274 |
Less: valuation allowance | (110,633) | (15,274) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Loss Carryforwards [Line Items] | ||
Net deferred tax asset | $ 110,633 | $ 15,274 |
Research and development credit | 15,509 | 3,207 |
Increase (decrease) in deferred tax asset valuation allowance | (95,400) | (3,500) |
Unrecognized tax benefits | 21,700 | |
Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 403,911 | 36,400 |
Operating loss carryforwards, not subject to expiration | 25,100 | 2,400 |
State and Local Jurisdiction | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 350,557 | 31,000 |
Vical | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 89,300 | |
Research and development credit | 9,300 | 9,300 |
Vical | Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 253,100 | |
Tax credit carryforwards | 24,600 | |
Research and development credit | 10,800 | |
Vical | State and Local Jurisdiction | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 291,500 | |
Federal research and development credits and orphan drug credit | Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | $ 30,300 | $ 3,200 |
INCOME TAXES - Summary of Feder
INCOME TAXES - Summary of Federal and State Carryforwards and Credits Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Federal NOLs | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 403,911 | $ 36,400 |
Federal NOLs | 2020 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 13,311 | |
Federal NOLs | 2021 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 9,866 | |
Federal NOLs | 2022 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 24,100 | |
Federal NOLs | 2023 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 24,743 | |
Federal NOLs | 2024 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 26,332 | |
Federal NOLs | 2025 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 242,941 | |
Federal NOLs | Indefinite | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 62,618 | |
State NOLs | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 350,557 | $ 31,000 |
State NOLs | 2020 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 0 | |
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 | 350,557 | |
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 | 9,073 | |
Federal R&D Credit | 2020 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 334 | |
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 | 7,387 | |
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 | 21,264 | |
Federal Orphan Drug Credit | 2020 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 2,288 | |
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 | 9,265 | |
State R&D Credit | 2020 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
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 | $ 9,265 |
SELECTED QUARTERLY FINANCIAL _3
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
Collaboration revenue | $ 669 | $ 1,183 | $ 2,573 | $ 3,492 | $ 2,473 | $ 3,042 | $ 373 | $ 5,000 | $ 7,917 | $ 10,888 |
Loss from operations | (10,841) | (6,055) | (2,979) | (4,593) | (3,601) | (2,299) | (3,315) | 764 | (24,468) | (8,451) |
Net income (loss) | (10,862) | (4,781) | (3,654) | (4,580) | (3,670) | (2,541) | (3,552) | 527 | (23,877) | (9,236) |
Net income (loss) attributable to common stockholders | $ (10,862) | $ (4,863) | $ (3,817) | $ 5,939 | $ (4,535) | $ (3,507) | $ (4,417) | $ (2,713) | $ (13,603) | $ (15,172) |
Basic net loss per common share attributable to common stockholders (in usd per share) | $ (1.38) | $ (1.65) | $ (6.49) | $ 10.08 | ||||||
Diluted net loss per common share attributable to common stockholders (in usd per share) | $ (1.38) | $ (1.65) | $ (6.49) | $ (2.48) | ||||||
Basic and diluted net loss per common share attributable to common stockholders (in usd per share) | $ (7.72) | $ (5.98) | $ (7.53) | $ (4.63) | $ (4.50) | $ (25.85) |
SUBSEQUENT EVENTS - Narrative (
SUBSEQUENT EVENTS - Narrative (Details) - USD ($) | Feb. 17, 2020 | Dec. 31, 2019 | Aug. 31, 2019 | Dec. 31, 2018 |
Subsequent Event [Line Items] | ||||
Common stock, shares issued (in shares) | 8,480,968 | 7,810,680 | 589,001 | |
Private Placement Offerings | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Common stock, shares issued (in shares) | 950,000 | |||
Aggregate gross purchase price | $ 2,000,000 | |||
Lincoln Park | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Purchase obligation | 28,000,000 | |||
Maximum commitment purchase amount | $ 1,000,000 | |||
Percentage of ownership after transaction | 9.99% | |||
Lincoln Park | Purchase Agreement | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Maximum shares allowed to be purchased | 100,000 | |||
Maximum share increase amount | 125,000 | |||
Closing sale price (in dollars per share) | $ 3 | |||
Lincoln Park | Regular Purchase | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Maximum share increase amount | 150,000 | |||
Closing sale price (in dollars per share) | $ 5 | |||
Bodor Laboratories, Inc. | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Non-refundable upfront fees | $ 1,000,000 | |||
Series A | Private Placement Offerings | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Stock issuable upon warrants (in shares) | 606,420 | |||
Exercise price (in usd per share) | $ 0.01 | |||
Series B | Private Placement Offerings | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Stock issuable upon warrants (in shares) | 1,556,420 | |||
Exercise price (in usd per share) | $ 1.16 |