COVER PAGE
COVER PAGE - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Current Fiscal Year End Date | --12-31 | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 000-21088 | |
Entity Registrant Name | BRICKELL BIOTECH, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 93-0948554 | |
Entity Address, Address Line One | 5777 Central Avenue, | |
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, $0.01 par value per share | |
Trading Symbol | BBI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 85,915,445 | |
Entity Central Index Key | 0000819050 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 24,408 | $ 30,115 |
Prepaid expenses and other current assets | 4,507 | 3,415 |
Total current assets | 28,915 | 33,530 |
Property and equipment, net | 72 | 30 |
Operating lease right-of-use asset | 86 | 74 |
Total assets | 29,073 | 33,634 |
Current liabilities: | ||
Accounts payable | 2,514 | 568 |
Accrued liabilities | 4,120 | 5,420 |
Lease liability, current portion | 50 | 74 |
Note payable, current portion | 0 | 291 |
Total current liabilities | 6,684 | 6,353 |
Lease liability, net of current portion | 36 | 0 |
Note payable, net of current portion | 0 | 146 |
Total liabilities | 6,720 | 6,499 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock, $0.01 par value, 300,000,000 and 100,000,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 71,945,222 and 53,551,461 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 719 | 536 |
Additional paid-in capital | 147,681 | 132,492 |
Accumulated deficit | (126,047) | (105,893) |
Total stockholders’ equity | 22,353 | 27,135 |
Total liabilities and stockholders’ equity | $ 29,073 | $ 33,634 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (PARENTHETICAL) - $ / shares | Jun. 30, 2021 | Apr. 19, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | |||
Common stock, par value (in usd per share) | $ 0.01 | $ 0.01 | |
Common stock, shares authorized | 300,000,000 | 300,000,000 | 100,000,000 |
Common stock, shares issued | 71,945,222 | 53,551,461 | |
Common stock, shares outstanding | 71,945,222 | 53,551,461 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Total revenue | $ 151 | $ 607 | $ 168 | $ 1,653 |
Operating expenses: | ||||
Research and development | 8,838 | 2,712 | 14,890 | 5,376 |
General and administrative | 2,891 | 3,021 | 5,858 | 5,502 |
Total operating expenses | 11,729 | 5,733 | 20,748 | 10,878 |
Loss from operations | (11,578) | (5,126) | (20,580) | (9,225) |
Investment and other income, net | 459 | 7 | 490 | 3 |
Interest expense | (30) | 0 | (64) | 0 |
Net loss | $ (11,149) | $ (5,119) | $ (20,154) | $ (9,222) |
Net loss per common share attributable to common stockholders basic (in usd per share) | $ (0.16) | $ (0.43) | $ (0.31) | $ (0.87) |
Net loss per common share attributable to common stockholders diluted (in usd per share) | $ (0.16) | $ (0.43) | $ (0.31) | $ (0.87) |
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic | 68,856,370 | 11,819,152 | 64,646,565 | 10,595,960 |
Weighted-average shares used to compute net income (loss) per share attributable to common stockholders, diluted | 68,856,370 | 11,819,152 | 64,646,565 | 10,595,960 |
Collaboration revenue | ||||
Total revenue | $ 0 | $ 607 | $ 0 | $ 1,653 |
Royalty revenue | ||||
Total revenue | $ 151 | $ 0 | $ 168 | $ 0 |
CONDENSED CONSOLIDATED STATMENT
CONDENSED CONSOLIDATED STATMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (11,149) | $ (5,119) | $ (20,154) | $ (9,222) |
Other comprehensive income: | ||||
Unrealized gain on available-for-sale marketable securities arising during holding period, net of tax benefit of $0 | 0 | 0 | 0 | 28 |
Total comprehensive loss | $ (11,149) | $ (5,119) | $ (20,154) | $ (9,194) |
CONDENSED CONSOLIDATED STATME_2
CONDENSED CONSOLIDATED STATMENTS OF COMPREHENSIVE LOSS (PARENTHETICAL) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Unrealized loss arising during holding period, tax benefit | $ 0 | $ 0 | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In-Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2019 | 8,480,968 | ||||
Beginning Balance at Dec. 31, 2019 | $ 7,574 | $ 85 | $ 92,497 | $ (28) | $ (84,980) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock and common stock purchase warrants, net of issuance costs (in shares) | 950,000 | ||||
Issuance of common stock and common stock purchase warrants, net of issuance costs | 1,990 | $ 10 | 1,980 | ||
Issuance of common stock upon exercise of warrants (in shares) | 221,293 | ||||
Issuance of common stock upon exercise of warrants | 15 | $ 2 | 13 | ||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | 19,643 | ||||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | (13) | (13) | |||
Stock-based compensation | 403 | 403 | |||
Unrealized gain on available-for-sale marketable securities | 28 | 28 | |||
Net loss | (4,103) | (4,103) | |||
Ending Balance (in shares) at Mar. 31, 2020 | 9,671,904 | ||||
Ending Balance at Mar. 31, 2020 | 5,894 | $ 97 | 94,880 | 0 | (89,083) |
Beginning Balance (in shares) at Dec. 31, 2019 | 8,480,968 | ||||
Beginning Balance at Dec. 31, 2019 | 7,574 | $ 85 | 92,497 | (28) | (84,980) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (9,222) | ||||
Ending Balance (in shares) at Jun. 30, 2020 | 26,671,573 | ||||
Ending Balance at Jun. 30, 2020 | 19,910 | $ 267 | 113,845 | 0 | (94,202) |
Beginning Balance (in shares) at Mar. 31, 2020 | 9,671,904 | ||||
Beginning Balance at Mar. 31, 2020 | 5,894 | $ 97 | 94,880 | 0 | (89,083) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock and common stock purchase warrants, net of issuance costs (in shares) | 14,790,133 | ||||
Issuance of common stock and common stock purchase warrants, net of issuance costs | 18,679 | $ 148 | 18,531 | ||
Issuance of common stock upon exercise of warrants (in shares) | 2,202,863 | ||||
Issuance of common stock upon exercise of warrants | 7 | $ 22 | (15) | ||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | 6,673 | ||||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | (4) | (4) | |||
Stock-based compensation | 453 | 453 | |||
Net loss | (5,119) | (5,119) | |||
Ending Balance (in shares) at Jun. 30, 2020 | 26,671,573 | ||||
Ending Balance at Jun. 30, 2020 | $ 19,910 | $ 267 | 113,845 | 0 | (94,202) |
Beginning Balance (in shares) at Dec. 31, 2020 | 53,551,461 | 53,551,461 | |||
Beginning Balance at Dec. 31, 2020 | $ 27,135 | $ 536 | 132,492 | 0 | (105,893) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of warrants (in shares) | 12,444,887 | ||||
Issuance of common stock upon exercise of warrants | 8,969 | $ 124 | 8,845 | ||
Issuance of common stock, net of issuance costs of $50 (in shares) | 1,083,548 | ||||
Issuance of common stock, net of issuance costs of $50 | 1,628 | $ 11 | 1,617 | ||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | 96,350 | ||||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | (52) | $ 1 | (53) | ||
Stock-based compensation | 469 | 469 | |||
Net loss | (9,005) | (9,005) | |||
Ending Balance (in shares) at Mar. 31, 2021 | 67,176,246 | ||||
Ending Balance at Mar. 31, 2021 | $ 29,144 | $ 672 | 143,370 | 0 | (114,898) |
Beginning Balance (in shares) at Dec. 31, 2020 | 53,551,461 | 53,551,461 | |||
Beginning Balance at Dec. 31, 2020 | $ 27,135 | $ 536 | 132,492 | 0 | (105,893) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (20,154) | ||||
Ending Balance (in shares) at Jun. 30, 2021 | 71,945,222 | 71,945,222 | |||
Ending Balance at Jun. 30, 2021 | $ 22,353 | $ 719 | 147,681 | 0 | (126,047) |
Beginning Balance (in shares) at Mar. 31, 2021 | 67,176,246 | ||||
Beginning Balance at Mar. 31, 2021 | 29,144 | $ 672 | 143,370 | 0 | (114,898) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock and common stock purchase warrants, net of issuance costs (in shares) | 4,768,976 | ||||
Issuance of common stock and common stock purchase warrants, net of issuance costs | 3,937 | $ 47 | 3,890 | ||
Stock-based compensation | 421 | 421 | |||
Net loss | $ (11,149) | (11,149) | |||
Ending Balance (in shares) at Jun. 30, 2021 | 71,945,222 | 71,945,222 | |||
Ending Balance at Jun. 30, 2021 | $ 22,353 | $ 719 | $ 147,681 | $ 0 | $ (126,047) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (PARENTHETICAL) - USD ($) $ in Thousands | 3 Months Ended | |||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | ||||
Issuance of common stock and common stock purchase warrants, issuance costs | $ 259 | $ 50 | $ 1,443 | $ 10 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (20,154) | $ (9,222) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 890 | 856 |
Gain on loan extinguishment | (437) | 0 |
Depreciation | 8 | 6 |
Reduction of discount on marketable securities | 0 | 25 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (1,092) | 512 |
Accounts payable | 1,932 | (1,679) |
Accrued liabilities | (1,352) | (135) |
Deferred revenue | 0 | (1,653) |
Net cash used in operating activities | (20,205) | (11,290) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Capital expenditures, net | (36) | 0 |
Maturities of marketable securities | 0 | 4,500 |
Net cash provided by (used in) investing activities | (36) | 4,500 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the exercise of warrants | 8,969 | 22 |
Proceeds from the issuance of common stock and warrants, net of issuance costs | 5,565 | 20,669 |
Proceeds from the issuance of note payable | 0 | 437 |
Net cash provided by financing activities | 14,534 | 21,128 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (5,707) | 14,338 |
CASH AND CASH EQUIVALENTS—BEGINNING | 30,115 | 7,232 |
CASH AND CASH EQUIVALENTS—ENDING | 24,408 | 21,570 |
Supplemental Disclosure of Non-Cash Investing and Financing Activities: | ||
Forgiveness of Paycheck Protection Program loan | $ 437 | $ 0 |
ORGANIZATION AND NATURE OF OPER
ORGANIZATION AND NATURE OF OPERATIONS | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND NATURE OF OPERATIONS | ORGANIZATION AND NATURE OF OPERATIONS Brickell Biotech, Inc. (the “Company” or “Brickell”) is a clinical-stage pharmaceutical company focused on the development of innovative and differentiated prescription therapeutics for debilitating skin diseases with a focus on its lead asset for the treatment of hyperhidrosis. The Company’s pivotal Phase 3 clinical-stage investigational product candidate, sofpironium bromide, is a new chemical entity that belongs to a class of medications called anticholinergics. The Company intends to develop sofpironium bromide as a potential best-in-class, self-administered, once daily, topical therapy for the treatment of primary axillary hyperhidrosis. The Company’s operations to date have been limited to business planning, raising capital, developing its pipeline assets (in particular sofpironium bromide), identifying product candidates, conducting clinical trials, and other research and development. Liquidity and Capital Resources The Company has incurred significant operating losses and has an accumulated deficit as a result of ongoing efforts to develop product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. For the six months ended June 30, 2021, the Company had a net loss of $20.2 million and net cash used in operating activities of $20.2 million. As of June 30, 2021, the Company had cash and cash equivalents of $24.4 million and an accumulated deficit of $126.0 million. The Company believes that its cash and cash equivalents as of June 30, 2021, combined with the net proceeds received from the subsequent sales of the Company’s common stock (see Note 8. “Subsequent Events”), are sufficient to fund its operations for at least the next 12 months from the issuance of these condensed consolidated financial statements. The Company expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. Additional funding will be required in the future to continue with the Company’s planned development and commercial-related activities. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Brickell Subsidiary, Inc., and are presented in United States (“U.S.”) dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the SEC for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s financial information. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the full year ending December 31, 2021, for any other interim period, or for any other future period. The condensed consolidated balance sheet as of December 31, 2020 has been derived from audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. All intercompany balances and transactions have been eliminated in consolidation. The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. The Company’s management performed an evaluation of its activities through the date of filing of these financial statements and concluded that there are no subsequent events requiring disclosure, other than as disclosed. Use of Estimates The Company’s condensed consolidated financial statements are prepared in accordance with U.S. GAAP, which requires it to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions. Risks and Uncertainties The Company’s business is subject to significant risks common to early-stage companies in the pharmaceutical industry including, but not limited to, the ability to develop appropriate formulations, scale up and produce the compounds; dependence on collaborative parties; uncertainties associated with obtaining and enforcing patents and other intellectual property rights; clinical implementation and success; the lengthy and expensive regulatory approval process; compliance with regulatory and other legal requirements; competition from other products; uncertainty of broad adoption of its approved products, if any, by physicians and patients; significant competition; ability to manage third-party manufacturers, suppliers, contract research organizations, business partners and other alliances; and obtaining additional financing to fund the Company’s efforts. The product candidates developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies prior to commercial sales in the U.S. or foreign jurisdictions, respectively. There can be no assurance that the Company’s current and future product candidates will receive the necessary approvals. If the Company is denied approval or approval is delayed, it may have a material adverse impact on the Company’s business and its financial condition. The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to develop and, if successful, commercialize its product candidates. There can be no assurance that such financing will be available or will be at terms acceptable to the Company. Fair Value Measurements Fair value is the price that the Company would receive to sell an asset or pay to transfer a liability in a timely transaction with an independent counterparty in the principal market, or in the absence of a principal market, the most advantageous market for the asset or liability. A three-tier hierarchy distinguishes between (1) inputs that reflect the assumptions market participants would use in pricing an asset or liability developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (2) inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing an asset or liability developed based on the best information available in the circumstances (unobservable inputs). The hierarchy is summarized in the three broad levels listed below: Level 1 —quoted prices in active markets for identical assets and liabilities Level 2 —other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.) Level 3 —significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities) The following table sets forth the fair value of the Company’s financial assets measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): Level 1 (1) June 30, December 31, Assets: Money market funds $ 23,202 $ 29,182 ____________ (1) No assets as of each respective date were identified as Level 2 or 3 based on the three-tier fair value hierarchy. The Company had no financial liabilities measured at fair value on a recurring basis as of each respective date. Fair Value of Financial Instruments The following methods and assumptions were used by the Company in estimating the fair values of each class of financial instrument disclosed herein: Money Market Funds— The carrying amounts reported as cash and cash equivalents in the condensed 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). Revenue Recognition The Company currently recognizes revenue primarily from licensing and royalty fees received under the Kaken Agreement described below, of which the terms of the agreement include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones, and royalties on net product sales. In March 2015, the Company entered into a license, development, and commercialization agreement (as amended, the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”). Under the Kaken Agreement, the Company granted to Kaken an exclusive right to develop, manufacture, and commercialize the Company’s sofpironium bromide compound in Japan and certain other Asian countries (the “Territory”). In exchange, Kaken paid the Company an upfront, non-refundable payment of $11.0 million (the “upfront fee”). In addition, the Company was entitled to receive aggregate payments of up to $10.0 million upon the achievement of specified development milestones, and $30.0 million upon the achievement of commercial milestones, as well as tiered royalties based on a percentage of net sales of licensed products in the Territory. The Kaken Agreement further provides that Kaken will be responsible for funding all development and commercial costs for the program in the Territory. Kaken was also required to enter into negotiations with the Company, to supply the Company, at cost, with clinical supplies to perform Phase 3 clinical trials in the U.S. In May 2018, the Company entered into an amendment to the Kaken Agreement, pursuant to which the Company received an upfront non-refundable fee of $15.6 million (the “Kaken R&D Payment”), which was initially recorded as deferred revenue, to provide the Company with research and development funds for the sole purpose of conducting certain clinical trials and other such research and development activities required to support the submission of a new drug application for sofpironium bromide. Upon receipt of the Kaken R&D Payment on May 31, 2018, a milestone payment originally due upon the first commercial sale in Japan was removed from the Kaken Agreement and all future royalties to the Company under the Kaken Agreement were reduced by 150 basis points. During the three and six months ended June 30, 2020, the Company recognized revenue of $0.6 million and $1.7 million, respectively, related to the Kaken R&D Payment. The Kaken R&D Payment was recognized in full by the end of the third quarter of 2020. 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 arrangements that it determines are within the scope of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. To date, the Company has not received approval for any drug candidates from the FDA. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. The Company utilizes judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Licenses of Intellectual Property 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 revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, and other revenues and earnings in the period of adjustment and future periods through the end of the performance obligation period. To date, Kaken has paid the Company $10.0 million in milestone payments under the Kaken Agreement. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Prior to 2020, the Company had not recognized any royalty revenue from any collaboration arrangement. In September 2020, Kaken received regulatory approval in Japan to manufacture and market sofpironium bromide gel, 5% (ECCLOCK ® ) for the treatment of primary axillary (underarm) hyperhidrosis. During the three and six months ended June 30, 2021, the Company recognized royalty revenue earned on a percentage of net sales of ECCLOCK in Japan of approximately $0.2 million. Research and Development Research and development costs are charged to expense when incurred and consist of costs incurred for independent and collaboration research and development activities. The major components of research and development costs include formulation development, clinical studies, clinical manufacturing costs, salaries and employee benefits, toxicology studies, allocations of various overhead and occupancy costs. Research costs typically consist of applied research, preclinical, and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis, and the transfer and scale-up of manufacturing at contract manufacturers. Clinical Trial Accruals Expense accruals related to clinical trials are based on the Company’s estimates of services received and efforts expended pursuant to contracts with multiple research institutions and third-party clinical research organizations that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing costs, the Company estimates the period over which services will be performed and the level of effort to be expended in each period based upon patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Any estimates of the level of services performed or the costs of these services could differ from actual results. Net Income (Loss) per Common Share Basic and diluted net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Company’s net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares. Diluted earnings per share gives effect to all dilutive potential common shares outstanding during the period, including stock options, restricted stock units, and warrants, using the treasury stock method, and redeemable convertible preferred stock and convertible promissory notes, using the if-converted method. In computing diluted earnings per share, the average stock price for the period is used in determining the number of shares assumed to be issued from the exercise of stock options, the vesting of restricted stock units, or the exercise of warrants. Potentially dilutive common share equivalents are excluded from the diluted earnings per share computation in net loss periods because their effect would be anti-dilutive. The following table sets forth the potential common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive: Three and Six Months Ended 2021 2020 Outstanding warrants 27,944,544 19,556,108 Outstanding options 6,716,167 1,578,231 Unvested restricted stock units 47,435 253,045 Total 34,708,146 21,387,384 Leases The Company accounts for leases under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 842 (“ASC 842”). Under ASC 842, the Company determines if an arrangement is a lease at inception. Operating leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company does not currently hold any financing leases. The Company has elected the practical expedient not to recognize on the balance sheet leases with terms of one year or less and not to separate lease components and non-lease components for long-term real estate leases. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company estimates the incremental borrowing rate based on industry peers in determining the present value of lease payments. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics. The Company’s facility operating lease has one single component. The lease component results in a right-of-use asset being recorded on the balance sheet, which is amortized as lease expense on a straight-line basis in the Company’s condensed consolidated statements of operations. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards has had or may have a material impact on the Company's condensed consolidated financial statements or disclosures. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
ACCRUED LIABILITIES | ACCRUED LIABILITIES Accrued liabilities consisted of the following (in thousands): June 30, December 31, Accrued contracted research and development services $ 2,922 $ 3,733 Accrued compensation 978 1,369 Accrued professional fees 220 318 Total $ 4,120 $ 5,420 |
NOTE PAYABLE
NOTE PAYABLE | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
NOTE PAYABLE | NOTE PAYABLE On April 15, 2020, the Company executed an unsecured promissory note to IberiaBank (the “PPP Loan”) pursuant to the U.S. Small Business Administration’s Paycheck Protection Program (the “PPP”) under Division A, Title I of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The Company used the PPP Loan proceeds in the principal amount of $0.4 million and bearing interest at a fixed rate of 1.00% per |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Operating Lease In August 2016, the Company entered into a five-year lease for office space in Boulder, Colorado that was scheduled to expire 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 leases 3,038 square feet of space in a multi-suite building. Base rental payments under the Boulder Lease were $4,430 per month during the first year of the Boulder Lease with an annual increase of 3.5% through October 31, 2021. In addition to base rental payments included in the contractual obligations table below, the Company is responsible for its pro rata share of the operating expenses for the building, which includes common area maintenance, utilities, property taxes, and insurance. Upon adoption of ASC 842, on January 1, 2019, the Company recognized a lease liability and corresponding right-of-use asset for the lease agreement by calculating the present value of lease payments, discounted at the Company’s estimated incremental borrowing rate of 12.0%, over the expected remaining term of 2.8 years. Effective June 17, 2021, the Boulder Lease was amended. The amendment extends the lease term to December 31, 2022. Base rent through October 31, 2021, was unchanged. The amendment provides for two months free rent and a fixed rate of $6,076 per month thereafter. The amendment also provides for an option to extend the lease for two additional terms of three years each with monthly rent payments determined at the time of renewal at the lower of $6,076 per month or current market rental rates. In accordance with ASC 842, upon modification of the Boulder Lease, the Company reassessed classification of the lease and determined that the lease still met the criteria to be classified as an operating lease. Furthermore, the Company remeasured the lease liability as of the effective date by calculating the present value of the new lease payments, discounted at the Company’s updated incremental borrowing rate of 11.0%, over the extended term of 18 months. Because the Company was not reasonably certain to exercise the renewal option, the option was not considered in determining the lease term, and associated potential additional payments were excluded from lease payments. Operating lease cost for the three months ended June 30, 2021 and 2020 was $23 thousand and $22 thousand, respectively. Lease expense for each of the six months ended June 30, 2021 and 2020 was less than $0.1 million. The following is a summary of the contractual obligations related to operating lease commitments as of June 30, 2021, and the effect such obligations are expected to have on the Company’s liquidity and cash flows in future periods (in thousands): 2021 (remaining six months) $ 57 2022 36 Total maturities 93 Less imputed interest (7) Present value of lease liability $ 86 Amended and Restated License Agreement with Bodor In February 2020, the Company, together with Brickell Subsidiary and Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor (collectively, “Bodor”) entered into an amended and restated license agreement (the “Amended and Restated License Agreement”). The Amended and Restated License Agreement supersedes the License Agreement, dated December 15, 2012, entered into between Brickell Subsidiary and Bodor, as amended by Amendment No. 1 to License Agreement, effective as of October 21, 2013, and Amendment No. 2 to License Agreement, effective as of March 31, 2015. The Amended and Restated License Agreement retains with the Company a worldwide, exclusive license to develop, manufacture, market, sell, and sublicense products containing the proprietary compound sofpironium bromide based upon the patents referenced in the Amended and Restated License Agreement for a defined field of use. As of June 30, 2021, under the original License Agreement and the Amended and Restated License Agreement, the Company had remaining obligations to pay Bodor (i) a royalty on sales of product outside Kaken’s territory, including a low single-digit royalty on sales of certain product not covered by the patent estate licensed from Bodor; (ii) approximately 50 to 55% of all royalties the Company receives from Kaken for sales of product within its territory; (iii) a percentage of non-royalty sublicensing income the Company receives from Kaken or other sublicensees; and (iv) up to an aggregate of $0.8 million (plus an additional $0.1 million for approvals of additional products) in cash payments and $1.0 million of shares of the Company’s common stock upon the achievement of certain regulatory and other milestones. |
CAPITAL STOCK
CAPITAL STOCK | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
CAPITAL STOCK | CAPITAL STOCK Common Stock On April 19, 2021, following approval by the Company’s stockholders, the Company filed an amendment to its amended and restated certificate of incorporation with the Secretary of State of the State of Delaware that increased the number of the Company’s authorized shares of common stock, par value $0.01 per share, from 100,000,000 to 300,000,000. Each share of the Company’s common stock is entitled to one vote, and the holders of the Company’s common stock are entitled to receive dividends when and as declared or paid by its board of directors. The Company had reserved authorized shares of common stock for future issuance at June 30, 2021 as follows: June 30, Common stock warrants 27,944,544 Common stock options outstanding 6,716,167 Shares available for grant under the Omnibus Plan 3,988,558 Unvested restricted stock units 47,435 Shares available for grant under the Employee Stock Purchase Plan 2,600,000 Total 41,296,704 Public Offerings of Common Stock and Warrants In October 2020, the Company completed a sale of 19,003,510 shares of its common stock, and, to certain investors, pre-funded warrants to purchase 1,829,812 shares of its common stock, and accompanying common stock warrants to purchase up to an aggregate of 20,833,322 shares of its common stock (the “October 2020 Offering”). Each share of common stock and pre-funded warrant to purchase one share of the Company’s common stock was sold together with a common warrant to purchase one share of the Company’s common stock. The public offering price of each share of the Company’s common stock and accompanying common warrant was $0.72 and $0.719 for each pre-funded warrant and accompanying common warrant, respectively. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The common warrants are exercisable at a price of $0.72 per share of the Company’s common stock and will expire five years from the date of issuance. The pre-funded warrants were exercised in October 2020 at an exercise price of $0.001 per share of the Company’s common stock. The October 2020 Offering resulted in net proceeds of approximately $13.7 million to the Company after deducting underwriting commissions and discounts and other offering expenses of $1.3 million and excluding the proceeds from the exercise of the warrants. During the six months ended June 30, 2021, 12,427,387 common warrants associated with the October 2020 Offering were exercised at a weighted-average exercise price of $0.72 per share, resulting in aggregate proceeds of approximately $8.9 million. In June 2020, the Company completed a sale of 14,790,133 shares of its common stock, and, to certain investors, pre-funded warrants to purchase 2,709,867 shares of its common stock, and accompanying common stock warrants to purchase up to an aggregate of 17,500,000 shares of its common stock (the “June 2020 Offering”) (and together with the October 2020 Offering, the “2020 Offerings”). Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase one share of common stock. The public offering price of each share of common stock and accompanying common warrant was $1.15 and $1.149 for each pre-funded warrant and accompanying common warrant, respectively. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The pre-funded warrants were exercised in the third quarter of 2020 at an exercise price of $0.001 per share of common stock. The common warrants were immediately exercisable at a price of $1.25 per share of common stock and will expire five years from the date of issuance. The June 2020 Offering resulted in approximately $18.7 million of net proceeds to the Company after deducting underwriting commissions and discounts and other offering expenses of $1.4 million and excluding the proceeds from the exercise of the warrants. Certain officers of the Company participated in the June 2020 Offering by purchasing an aggregate purchase price of $0.2 million of the Company's common stock and warrants. During the six months ended June 30, 2021, 17,500 common warrants associated with the June 2020 Offering were exercised at a weighted-average exercise price of $1.25 per share, resulting in aggregate proceeds of approximately $22 thousand. The Company is using the net proceeds from the 2020 Offerings for research and development, including clinical trials, working capital, and general corporate purposes. At Market Issuance Sales Agreements In April 2020, the Company entered into an At Market Issuance Sales Agreement (the “2020 ATM Agreement”) with Oppenheimer & Co. Inc. (“Oppenheimer”) as the Company’s sales agent. Pursuant to the terms of the 2020 ATM Agreement, the Company may sell from time to time through Oppenheimer shares of its common stock having an aggregate offering price of up to $8.0 million. Such shares are issued pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-236353). Sales of the shares are made by means of ordinary brokers’ transactions on The Nasdaq Capital Market at market prices or as otherwise agreed by the Company and Oppenheimer. Under the terms of the 2020 ATM Agreement, the Company may also sell the shares from time to time to Oppenheimer as principal for its own account at a price to be agreed upon at the time of sale. Any sale of the shares to Oppenheimer as principal would be pursuant to the terms of a separate placement notice between the Company and Oppenheimer. During the three months ended June 30, 2021, the Company sold 5,500 shares under the 2020 ATM Agreement at a weighted-average price of $1.16 per share, for aggregate net proceeds of $6 thousand, after giving effect to a 3% commission to Oppenheimer as agent. During the six months ended June 30, 2021, the Company sold 1,089,048 shares under the 2020 ATM Agreement at a weighted-average price of $1.55 per share, for aggregate net proceeds of approximately $1.6 million, after giving effect to a 3% commission to Oppenheimer as agent. As of June 30, 2021, approximately $2.6 million of shares of common stock were remaining, but had not yet been sold by the Company under the 2020 ATM Agreement. In March 2021, the Company entered into an At Market Issuance Sales Agreement (the “2021 ATM Agreement”) with Oppenheimer and William Blair & Company, L.L.C. as the Company’s sales agents (the “Agents”). Pursuant to the terms of the 2021 ATM Agreement, the Company may sell from time to time through the Agents shares of its common stock having an aggregate offering price of up to $50.0 million. Such shares are issued pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-254037). Sales of the shares are made by means of ordinary brokers’ transactions on The Nasdaq Capital Market at market prices or as otherwise agreed by the Company and the Agents. Under the terms of the 2021 ATM Agreement, the Company may also sell the shares from time to time to an Agent as principal for its own account at a price to be agreed upon at the time of sale. Any sale of the shares to an Agent as principal would be pursuant to the terms of a separate placement notice between the Company and such Agent. During the three and six months ended June 30, 2021, the Company sold 3,963,476 shares under the 2021 ATM Agreement at a weighted-average price of $0.89 per share, for aggregate net proceeds of $3.4 million, after giving effect to a 3% commission to the Agents. As of June 30, 2021, approximately $46.5 million of shares of common stock were remaining, but had not yet been sold by the Company under the 2021 ATM Agreement. Private Placement Offerings In February 2020, the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into (i) a securities purchase agreement (the “Securities Purchase Agreement”); (ii) a purchase agreement (the “Purchase Agreement”); and (iii) a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Securities Purchase Agreement, Lincoln Park purchased, and the Company sold, (i) an aggregate of 950,000 shares of common stock (the “Common Shares”); (ii) a warrant to initially purchase an aggregate of up to 606,420 shares of common stock at an exercise price of $0.01 per share (the “Series A Warrant”); and (iii) a warrant to initially purchase an aggregate of up to 1,556,420 shares of common stock at an exercise price of $1.16 per share (the “Series B Warrant,” and together with the Series A Warrant, the “Warrants”). The aggregate gross purchase price for the Common Shares and the Warrants was $2.0 million. Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $28.0 million in the aggregate of shares of common stock. In order to retain maximum flexibility to issue and sell up to the maximum of $28.0 million of the Company’s common stock under the Purchase Agreement, the Company sought and, at its annual meeting on April 19, 2021, received, stockholder approval for the sale and issuance of common stock in connection with the Purchase Agreement under Nasdaq Listing Rule 5635(d). Sales of common stock by the Company will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on August 14, 2020 (the “Commencement Date”). Following the Commencement Date, under the Purchase Agreement, on any business day selected by the Company, the Company may direct Lincoln Park to purchase up to 100,000 shares of common stock on such business day (each, a “Regular Purchase”), provided, however, that (i) the Regular Purchase may be increased to up to 125,000 shares, provided that the closing sale price of the common stock is not below $3.00 on the purchase date; and (ii) the Regular Purchase may be increased to up to 150,000 shares, provided that the closing sale price of the common stock is not below $5.00 on the purchase date. In each case, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $1,000,000. The purchase price per share for each such Regular Purchase will be based on prevailing market prices of common stock immediately preceding the time of sale. In addition to Regular Purchases, the Company may direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the Purchase Agreement if it would result in Lincoln Park beneficially owning more than 9.99% of the outstanding shares of common stock. During the three and six months ended June 30, 2021, the Company sold to Lincoln Park 800,000 shares under the Purchase Agreement at a weighted-average price of $0.81 per share, for aggregate net proceeds of $0.6 million. As of June 30, 2021, approximately $27.3 million of shares of common stock were remaining, but had not yet been sold by the Company under the Purchase Agreement. The Company agreed with Lincoln Park that it will not enter into any “variable rate” transactions with any third party, subject to certain exceptions, for a period defined in the Purchase Agreement. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. The Securities Purchase Agreement, the Purchase Agreement, and the Registration Rights Agreement contain customary representations, warranties, agreements, and conditions to completing future sale transactions, indemnification rights, and obligations of the parties. Preferred Stock |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION Equity Incentive Plans 2020 Omnibus Plan On April 20, 2020, the Company’s stockholders approved the 2020 Omnibus Long-Term Incentive Plan (the “Omnibus Plan”), which replaced, with respect to new award grants, the Company’s 2009 Equity Incentive Plan, as amended and restated (the “2009 Plan”), and the Vical Equity Incentive Plan (the “Vical Plan”) (collectively, the “Prior Plans”) that were previously in effect. Following the approval of the Omnibus Plan on April 20, 2020, no additional grants will be made pursuant to the Prior Plans, but awards outstanding under those plans as of that date remain outstanding in accordance with their terms. On August 31, 2020 and April 19, 2021, the Company’s stockholders approved increases in the number of shares of common stock authorized for issuance under the Omnibus Plan by 4,500,000 and 4,000,000 shares, respectively, and as of June 30, 2021, 9,125,000 shares were authorized and 5,379,767 shares were subject to outstanding awards under the Omnibus Plan. As of June 30, 2021, 3,988,558 shares remained available for grant under the Omnibus Plan. 2009 Equity Incentive Plan The 2009 Plan was replaced by the Omnibus Plan on April 20, 2020, and as a result, as of June 30, 2021, there were no remaining shares available for new grants under the 2009 Plan. However, as of June 30, 2021, 1,266,655 shares were subject to outstanding awards under the 2009 Plan, which awards remain outstanding in accordance with their terms. Vical Equity Incentive Plan In connection with the merger in 2019, the Company adopted the Vical Plan, which was replaced by the Omnibus Plan on April 20, 2020. As a result, as of June 30, 2021, there were no remaining shares available for new grants under the Vical Plan. However, as of June 30, 2021, 117,180 shares were subject to outstanding awards under the Vical Plan, which awards remain outstanding in accordance with their terms. Employee Stock Purchase Plan On April 19, 2021, the Company’s stockholders approved the Brickell Biotech, Inc. Employee Stock Purchase Plan (the “ESPP”), which had a first eligible purchase period commencing on July 1, 2021. The ESPP allows qualified employees to purchase shares of the Company’s common stock at a price per share equal to 85% of the lower of: (i) the closing price of the Company’s common stock on the first trading day of the applicable purchase period or (ii) the closing price of the Company’s common stock on the last trading day of the applicable purchase period. New six-month purchase periods begin each January 1 and July 1. As of June 30, 2021, the Company had 2,600,000 shares available for issuance under the ESPP. Stock-Based Compensation Expense Total stock-based compensation expense reported in the condensed consolidated statements of operations was allocated as follows (in thousands): Three Months Ended Six Months Ended 2021 2020 2021 2020 Research and development $ 88 $ 68 $ 197 $ 172 General and administrative 333 385 693 684 Total stock-based compensation expense $ 421 $ 453 $ 890 $ 856 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS Public Offering of Common Stock In July 2021, the Company entered into an amended and restated underwriting agreement (as amended, the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC (the “Underwriter”), pursuant to which the Company issued and sold, in an underwritten public offering (the “July 2021 Offering”), 11,290,323 shares (the “Base Shares”) of the Company’s common stock. In addition, the Underwriter fully exercised its option to purchase 1,693,548 additional shares of common stock (the “Option Shares,” and together with the Base Shares, the “Shares”). The offering price to the public in the July 2021 Public Offering was $0.62 per Share, and the Underwriter agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $0.5828 per Share, representing an underwriting discount of six percent (6.0%). The July 2021 Offering resulted in net proceeds of approximately $7.3 million, after deducting underwriting discounts and commissions and offering expenses. The Company anticipates using the net proceeds from the July 2021 Offering for research and development, including clinical trials, working capital, and general corporate purposes. The Underwriting Agreement also contains representations, warranties, indemnification, and other provisions customary for transactions of this nature. Pursuant to the Underwriting Agreement, the Company and its directors and officers agreed, for a period of 45 days, subject to certain exceptions, not to offer, sell, pledge, or otherwise dispose of the Company’s common stock and other of the Company’s securities that they beneficially own, including securities that are convertible into shares of common stock and securities that are exchangeable or exercisable for shares of common stock, without the prior written consent of the Underwriter. Lincoln Park Purchase Agreement Subsequent to June 30, 2021, and through August 12, 2021, the Company sold to Lincoln Park 500,000 shares of common stock under the Purchase Agreement at a weighted-average price of $0.81 per share, for aggregate net proceeds of approximately $0.4 million. At Market Issuance Sales Agreements Subsequent to June 30, 2021, and through August 12, 2021, the Company sold 486,352 shares of common stock under the 2021 ATM Agreement at a weighted-average price of $0.86 per share, for aggregate net proceeds of approximately $0.4 million. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Brickell Subsidiary, Inc., and are presented in United States (“U.S.”) dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the SEC for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s financial information. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the full year ending December 31, 2021, for any other interim period, or for any other future period. The condensed consolidated balance sheet as of December 31, 2020 has been derived from audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. All intercompany balances and transactions 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 condensed consolidated financial statements are prepared in accordance with U.S. GAAP, which requires it to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions. |
Fair Value Measurements | Fair Value Measurements Fair value is the price that the Company would receive to sell an asset or pay to transfer a liability in a timely transaction with an independent counterparty in the principal market, or in the absence of a principal market, the most advantageous market for the asset or liability. A three-tier hierarchy distinguishes between (1) inputs that reflect the assumptions market participants would use in pricing an asset or liability developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (2) inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing an asset or liability developed based on the best information available in the circumstances (unobservable inputs). The hierarchy is summarized in the three broad levels listed below: Level 1 —quoted prices in active markets for identical assets and liabilities Level 2 —other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.) Level 3 —significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities) |
Revenue Recognition | Revenue Recognition The Company currently recognizes revenue primarily from licensing and royalty fees received under the Kaken Agreement described below, of which the terms of the agreement include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones, and royalties on net product sales. In March 2015, the Company entered into a license, development, and commercialization agreement (as amended, the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”). Under the Kaken Agreement, the Company granted to Kaken an exclusive right to develop, manufacture, and commercialize the Company’s sofpironium bromide compound in Japan and certain other Asian countries (the “Territory”). In exchange, Kaken paid the Company an upfront, non-refundable payment of $11.0 million (the “upfront fee”). In addition, the Company was entitled to receive aggregate payments of up to $10.0 million upon the achievement of specified development milestones, and $30.0 million upon the achievement of commercial milestones, as well as tiered royalties based on a percentage of net sales of licensed products in the Territory. The Kaken Agreement further provides that Kaken will be responsible for funding all development and commercial costs for the program in the Territory. Kaken was also required to enter into negotiations with the Company, to supply the Company, at cost, with clinical supplies to perform Phase 3 clinical trials in the U.S. In May 2018, the Company entered into an amendment to the Kaken Agreement, pursuant to which the Company received an upfront non-refundable fee of $15.6 million (the “Kaken R&D Payment”), which was initially recorded as deferred revenue, to provide the Company with research and development funds for the sole purpose of conducting certain clinical trials and other such research and development activities required to support the submission of a new drug application for sofpironium bromide. Upon receipt of the Kaken R&D Payment on May 31, 2018, a milestone payment originally due upon the first commercial sale in Japan was removed from the Kaken Agreement and all future royalties to the Company under the Kaken Agreement were reduced by 150 basis points. During the three and six months ended June 30, 2020, the Company recognized revenue of $0.6 million and $1.7 million, respectively, related to the Kaken R&D Payment. The Kaken R&D Payment was recognized in full by the end of the third quarter of 2020. 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 arrangements that it determines are within the scope of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. To date, the Company has not received approval for any drug candidates from the FDA. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. The Company utilizes judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Licenses of Intellectual Property 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 revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, and other revenues and earnings in the period of adjustment and future periods through the end of the performance obligation period. To date, Kaken has paid the Company $10.0 million in milestone payments under the Kaken Agreement. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Prior to 2020, the Company had not recognized any royalty revenue from any collaboration arrangement. In September 2020, Kaken received regulatory approval in Japan to manufacture and market sofpironium bromide gel, 5% (ECCLOCK ® ) for the treatment of primary axillary (underarm) hyperhidrosis. During the three and six months ended June 30, 2021, the Company recognized royalty revenue earned on a percentage of net sales of ECCLOCK in Japan of approximately $0.2 million. |
Research and Development | Research and Development Research and development costs are charged to expense when incurred and consist of costs incurred for independent and collaboration research and development activities. The major components of research and development costs include formulation development, clinical studies, clinical manufacturing costs, salaries and employee benefits, toxicology studies, allocations of various overhead and occupancy costs. Research costs typically consist of applied research, preclinical, and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis, and the transfer and scale-up of manufacturing at contract manufacturers. |
Clinical Trial Accruals | Clinical Trial Accruals Expense accruals related to clinical trials are based on the Company’s estimates of services received and efforts expended pursuant to contracts with multiple research institutions and third-party clinical research organizations that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing costs, the Company estimates the period over which services will be performed and the level of effort to be expended in each period based upon patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Any estimates of the level of services performed or the costs of these services could differ from actual results. |
Net Income (Loss) per Common Share | Net Income (Loss) per Common Share Basic and diluted net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Company’s net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares. Diluted earnings per share gives effect to all dilutive potential common shares outstanding during the period, including stock options, restricted stock units, and warrants, using the treasury stock method, and redeemable convertible preferred stock and convertible promissory notes, using the if-converted method. In computing diluted earnings per share, the average stock price for the period is used in determining the number of shares assumed to be issued from the exercise of stock options, the vesting of restricted stock units, or the exercise of warrants. Potentially dilutive common share equivalents are excluded from the diluted earnings per share computation in net loss periods because their effect would be anti-dilutive. |
Leases | Leases The Company accounts for leases under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 842 (“ASC 842”). Under ASC 842, the Company determines if an arrangement is a lease at inception. Operating leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company does not currently hold any financing leases. The Company has elected the practical expedient not to recognize on the balance sheet leases with terms of one year or less and not to separate lease components and non-lease components for long-term real estate leases. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company estimates the incremental borrowing rate based on industry peers in determining the present value of lease payments. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics. The Company’s facility operating lease has one single component. The lease component results in a right-of-use asset being recorded on the balance sheet, which is amortized as lease expense on a straight-line basis in the Company’s condensed consolidated statements of operations. |
New Accounting Pronouncements | New Accounting PronouncementsFrom time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards has had or may have a material impact on the Company's condensed consolidated financial statements or disclosures |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Fair Value Measurements, Recurring and Nonrecurring | The following table sets forth the fair value of the Company’s financial assets measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): Level 1 (1) June 30, December 31, Assets: Money market funds $ 23,202 $ 29,182 ____________ (1) No assets as of each respective date were identified as Level 2 or 3 based on the three-tier fair value hierarchy. The Company had no financial liabilities measured at fair value on a recurring basis as of each respective date. |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following table sets forth the potential common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive: Three and Six Months Ended 2021 2020 Outstanding warrants 27,944,544 19,556,108 Outstanding options 6,716,167 1,578,231 Unvested restricted stock units 47,435 253,045 Total 34,708,146 21,387,384 |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): June 30, December 31, Accrued contracted research and development services $ 2,922 $ 3,733 Accrued compensation 978 1,369 Accrued professional fees 220 318 Total $ 4,120 $ 5,420 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021, and the effect such obligations are expected to have on the Company’s liquidity and cash flows in future periods (in thousands): 2021 (remaining six months) $ 57 2022 36 Total maturities 93 Less imputed interest (7) Present value of lease liability $ 86 |
CAPITAL STOCK (Tables)
CAPITAL STOCK (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Reserved Authorized Shares of Common Stock | The Company had reserved authorized shares of common stock for future issuance at June 30, 2021 as follows: June 30, Common stock warrants 27,944,544 Common stock options outstanding 6,716,167 Shares available for grant under the Omnibus Plan 3,988,558 Unvested restricted stock units 47,435 Shares available for grant under the Employee Stock Purchase Plan 2,600,000 Total 41,296,704 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Share-Based Compensation Expense | Total stock-based compensation expense reported in the condensed consolidated statements of operations was allocated as follows (in thousands): Three Months Ended Six Months Ended 2021 2020 2021 2020 Research and development $ 88 $ 68 $ 197 $ 172 General and administrative 333 385 693 684 Total stock-based compensation expense $ 421 $ 453 $ 890 $ 856 |
ORGANIZATION AND NATURE OF OP_2
ORGANIZATION AND NATURE OF OPERATIONS - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||
Net loss | $ 11,149 | $ 9,005 | $ 5,119 | $ 4,103 | $ 20,154 | $ 9,222 | |
Net cash used in operating activities | 20,205 | $ 11,290 | |||||
Cash and cash equivalents | 24,408 | 24,408 | $ 30,115 | ||||
Accumulated deficit | $ 126,047 | $ 126,047 | $ 105,893 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | 6 Months Ended |
Jun. 30, 2021segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value of Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Assets: | ||
Money market funds | $ 23,202 | $ 29,182 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
May 31, 2018 | Mar. 31, 2015 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | $ 151 | $ 607 | $ 168 | $ 1,653 | ||
Royalty revenue | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | $ 151 | 0 | 168 | $ 0 | ||
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 | |||||
Basis point reduction | 1.50% | |||||
Revenue recognized | $ 600 | $ 1,700 | ||||
Milestone payment received | 10,000 | |||||
Collaborative Arrangement | Royalty revenue | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | $ 200 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Common Shares Excluded from EPS Calculations (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 34,708,146 | 21,387,384 |
Outstanding warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 27,944,544 | 19,556,108 |
Outstanding options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 6,716,167 | 1,578,231 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS | 47,435 | 253,045 |
ACCRUED LIABILITIES - Summary o
ACCRUED LIABILITIES - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued contracted research and development services | $ 2,922 | $ 3,733 |
Accrued compensation | 978 | 1,369 |
Accrued professional fees | 220 | 318 |
Total | $ 4,120 | $ 5,420 |
NOTE PAYABLE - Narrative (Detai
NOTE PAYABLE - Narrative (Details) - Paycheck Protection Program $ in Millions | Apr. 15, 2020USD ($) |
Debt Instrument [Line Items] | |
Face amount | $ 0.4 |
Stated rate | 1.00% |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2021USD ($)ft²renewalTerm | Dec. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)ft²renewalTerm | Jun. 30, 2020USD ($) | Jan. 01, 2022USD ($) | Dec. 31, 2018 | Aug. 31, 2016 | |
Loss Contingencies [Line Items] | ||||||||
Lease term | 5 years | |||||||
Number of additional terms | renewalTerm | 2 | 2 | ||||||
Renewal term | 3 years | 3 years | ||||||
Area of leased property | ft² | 3,038 | 3,038 | ||||||
Monthly payment, initial year | $ 4,430 | $ 4,430 | ||||||
Annual payment percentage increase | 3.50% | 3.50% | ||||||
Discount rate | 11.00% | 11.00% | 12.00% | |||||
Expected remaining term | 18 months | 18 months | 2 years 9 months 18 days | |||||
Lease expense | $ 23,000 | $ 22,000 | $ 100,000 | $ 100,000 | ||||
Research and development | 8,838,000 | 2,712,000 | 14,890,000 | 5,376,000 | ||||
Forecast | ||||||||
Loss Contingencies [Line Items] | ||||||||
Monthly payment, thereafter | $ 6,076 | |||||||
Bodor Laboratories, Inc. | ||||||||
Loss Contingencies [Line Items] | ||||||||
Cash payment | 800,000 | |||||||
Payments for additional product approval | 100,000 | |||||||
Value of shares issued in agreement | 1,000,000 | |||||||
Milestone payment | 500,000 | 500,000 | ||||||
Research and development | $ 0 | $ 1,000,000 | $ 1,500,000 | $ 0 | $ 1,500,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Schedule of Contractual Obligations (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 (remaining six months) | $ 57 |
2022 | 36 |
Total maturities | 93 |
Less imputed interest | (7) |
Present value of lease liability | $ 86 |
CAPITAL STOCK - Narrative (Deta
CAPITAL STOCK - Narrative (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Oct. 31, 2020USD ($)$ / sharesshares | Jun. 30, 2020USD ($)$ / sharesshares | Feb. 29, 2020USD ($)$ / sharesshares | Jun. 30, 2021USD ($)$ / sharesshares | Jun. 30, 2021USD ($)$ / sharesshares | Jun. 30, 2020USD ($)$ / sharesshares | Apr. 19, 2021shares | Mar. 31, 2021USD ($) | Dec. 31, 2020$ / sharesshares | Sep. 30, 2020$ / shares | Apr. 30, 2020USD ($) | |
Class of Stock [Line Items] | |||||||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | 300,000,000 | 100,000,000 | |||||||
Sale of stock, expiration term | 5 years | ||||||||||
Proceeds from the exercise of warrants | $ | $ 8,969,000 | $ 22,000 | |||||||||
Common stock, shares issued | 71,945,222 | 71,945,222 | 53,551,461 | ||||||||
Aggregate purchase price for stock and warrants | $ | $ 200,000 | ||||||||||
Preferred shares authorized | 5,000,000 | 5,000,000 | |||||||||
Temporary equity, par or stated value per share (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | |||||||||
Preferred stock shares outstanding | 0 | 0 | |||||||||
Common stock warrants | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 0.72 | $ 0.72 | |||||||||
Lincoln Park | |||||||||||
Class of Stock [Line Items] | |||||||||||
Purchase obligation | $ | $ 28,000,000 | ||||||||||
Purchase obligation, term | 36 months | ||||||||||
Maximum commitment purchase amount | $ | $ 1,000,000 | ||||||||||
Percentage of ownership after transaction | 9.99% | ||||||||||
Pre-Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | |||||||||
October 2020 Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of shares authorized to be repurchased | 20,833,322 | ||||||||||
Exercise price (in usd per share) | $ / shares | $ 0.72 | $ 0.72 | |||||||||
Consideration received on transaction | $ | $ 13,700,000 | ||||||||||
Commissions discounts and other offering expenses | $ | $ 1,300,000 | ||||||||||
Stock issuable upon warrants (in shares) | 12,427,387 | 12,427,387 | |||||||||
Proceeds from the exercise of warrants | $ | $ 8,900,000 | ||||||||||
October 2020 Offering | Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of shares issued in transaction | 19,003,510 | ||||||||||
October 2020 Offering | Common stock warrants | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of shares authorized to be repurchased | 1,829,812 | ||||||||||
Closing sale price (in usd per share) | $ / shares | $ 0.72 | ||||||||||
October 2020 Offering | Pre-Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Closing sale price (in usd per share) | $ / shares | $ 0.719 | ||||||||||
Common Stock Public Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 1.25 | $ 1.25 | $ 1.25 | $ 1.25 | |||||||
Sale of stock, expiration term | 5 years | ||||||||||
Stock issuable upon warrants (in shares) | 17,500 | 17,500 | |||||||||
Proceeds from the exercise of warrants | $ | $ 22,000 | ||||||||||
Common stock, shares issued | 14,790,133 | 14,790,133 | |||||||||
Net proceeds from common stock public offering | $ | $ 18,700,000 | ||||||||||
Underwriting commissions, discounts, and other offering expenses | $ | $ 1,400,000 | ||||||||||
Common Stock Public Offering | Pre-Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock issuable upon warrants (in shares) | 2,709,867 | 2,709,867 | |||||||||
Public offering price (in usd per share) | $ / shares | $ 1.15 | $ 1.15 | |||||||||
Common Stock Public Offering | Accompanying Common Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock issuable upon warrants (in shares) | 17,500,000 | 17,500,000 | |||||||||
Public offering price (in usd per share) | $ / shares | $ 1.149 | $ 1.149 | |||||||||
2020 At Market Issuance Sales Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Consideration received on transaction | $ | $ 6,000 | $ 1,600,000 | |||||||||
Aggregate offering price | $ | $ 8,000,000 | ||||||||||
Sale of stock, weighted average price per share (in usd per share) | $ / shares | $ 1.16 | $ 1.55 | |||||||||
Sale of stock additional shares authorized amount | $ | $ 2,600,000 | $ 2,600,000 | |||||||||
2020 At Market Issuance Sales Agreement | Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of shares issued in transaction | 5,500 | 1,089,048 | |||||||||
2021 At Market Issuance Sales Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Closing sale price (in usd per share) | $ / shares | $ 0.89 | $ 0.89 | |||||||||
Consideration received on transaction | $ | $ 3,400,000 | ||||||||||
Aggregate offering price | $ | $ 50,000,000 | ||||||||||
Sale of stock, percentage of commission | 0.03 | ||||||||||
Sale of stock additional shares authorized amount | $ | $ 46,500,000 | $ 46,500,000 | |||||||||
2021 At Market Issuance Sales Agreement | Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of shares issued in transaction | 3,963,476 | 3,963,476 | |||||||||
Private Placement Offerings | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock, shares issued | 950,000 | ||||||||||
Aggregate gross purchase price | $ | $ 2,000,000 | ||||||||||
Private Placement Offerings | Series A | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 0.01 | ||||||||||
Stock issuable upon warrants (in shares) | 606,420 | ||||||||||
Private Placement Offerings | Series B | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 1.16 | ||||||||||
Stock issuable upon warrants (in shares) | 1,556,420 | ||||||||||
Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Sale of stock additional shares authorized amount | $ | $ 27,300,000 | $ 27,300,000 | |||||||||
Purchase Agreement | Lincoln Park | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of shares issued in transaction | 800,000 | 800,000 | |||||||||
Closing sale price (in usd per share) | $ / shares | $ 3 | $ 0.81 | $ 0.81 | ||||||||
Consideration received on transaction | $ | $ 600,000 | $ 600,000 | |||||||||
Maximum shares allowed to be purchased | 100,000 | ||||||||||
Maximum share increase amount | 125,000 | ||||||||||
Regular Purchase | Lincoln Park | |||||||||||
Class of Stock [Line Items] | |||||||||||
Closing sale price (in usd per share) | $ / shares | $ 5 | ||||||||||
Maximum share increase amount | 150,000 |
CAPITAL STOCK - Reserved Author
CAPITAL STOCK - Reserved Authorized Shares of Common Stock (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuance | 41,296,704 | |
Unvested restricted stock units | 34,708,146 | 21,387,384 |
Unvested restricted stock units | ||
Class of Stock [Line Items] | ||
Unvested restricted stock units | 47,435 | 253,045 |
Outstanding warrants | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuance | 27,944,544 | |
Common stock options outstanding | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuance | 6,716,167 | |
Outstanding options | 2020 Omnibus Plan | ||
Class of Stock [Line Items] | ||
Shares available for grant | 3,988,558 | |
Employee Stock | ||
Class of Stock [Line Items] | ||
Shares available for grant | 2,600,000 | |
Employee Stock | Employee Stock Purchase Plan | ||
Class of Stock [Line Items] | ||
Shares available for grant | 2,600,000 |
STOCK-BASED COMPENSATION - Narr
STOCK-BASED COMPENSATION - Narrative (Details) - shares | Apr. 19, 2021 | Aug. 31, 2020 | Jun. 30, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock purchase offering period | 6 months | ||
2020 Omnibus Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares authorized | 9,125,000 | ||
Options | 2020 Omnibus Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares of common stock reserved for future issuance | 4,500,000 | ||
Number of additional shares authorized | 4,000,000 | ||
Options outstanding (in shares) | 5,379,767 | ||
Shares available for grant | 3,988,558 | ||
Options | 2009 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options outstanding (in shares) | 1,266,655 | ||
Shares available for grant | 0 | ||
Options | Vical Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options outstanding (in shares) | 117,180 | ||
Shares available for grant | 0 | ||
Employee Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares available for grant | 2,600,000 | ||
Employee Stock | Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares available for grant | 2,600,000 | ||
Discount from market price, purchase date | 85.00% |
STOCK-BASED COMPENSATION - Shar
STOCK-BASED COMPENSATION - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 421 | $ 453 | $ 890 | $ 856 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | 88 | 68 | 197 | 172 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 333 | $ 385 | $ 693 | $ 684 |
SUBSEQUENT EVENTS - Narrative (
SUBSEQUENT EVENTS - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Aug. 12, 2021USD ($)$ / sharesshares | Jul. 31, 2021USD ($)$ / sharesshares | Jun. 30, 2021USD ($)shares | Jun. 30, 2021USD ($)shares | Jun. 30, 2020USD ($) | Oct. 31, 2020$ / shares | Sep. 30, 2020$ / shares | |
Subsequent Event [Line Items] | |||||||
Proceeds from the exercise of warrants | $ | $ 8,969 | $ 22 | |||||
Pre-Funded Warrant | |||||||
Subsequent Event [Line Items] | |||||||
Exercise price (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | |||||
2020 At Market Issuance Sales Agreement | |||||||
Subsequent Event [Line Items] | |||||||
Consideration received on transaction | $ | $ 6 | $ 1,600 | |||||
2020 At Market Issuance Sales Agreement | Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Number of shares issued in transaction | shares | 5,500 | 1,089,048 | |||||
Subsequent Event | July 2021 Offering | |||||||
Subsequent Event [Line Items] | |||||||
Number of shares issued in transaction | shares | 11,290,323 | ||||||
Closing sale price (in usd per share) | $ / shares | $ 0.62 | ||||||
Sale of stock, price per share, discounted price (in usd per share) | $ / shares | $ 0.5828 | ||||||
Sale of stock, price per share, discount percentage | 0.060 | ||||||
Consideration received on transaction | $ | $ 7,300 | ||||||
Subsequent Event | Over-Allotment Option | |||||||
Subsequent Event [Line Items] | |||||||
Number of shares issued in transaction | shares | 1,693,548 | ||||||
Subsequent Event | Lincoln Park Purchase Agreement | |||||||
Subsequent Event [Line Items] | |||||||
Number of shares issued in transaction | shares | 500,000 | ||||||
Closing sale price (in usd per share) | $ / shares | $ 0.81 | ||||||
Consideration received on transaction | $ | $ 400 | ||||||
Subsequent Event | 2020 At Market Issuance Sales Agreement | Pre-Funded Warrant | |||||||
Subsequent Event [Line Items] | |||||||
Stock issuable upon warrants (in shares) | shares | 486,352 | ||||||
Exercise price (in usd per share) | $ / shares | $ 0.86 | ||||||
Proceeds from the exercise of warrants | $ | $ 400 |