Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 04, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-37880 | ||
Entity Registrant Name | Novan, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-4427682 | ||
Entity Address, Address Line One | 4020 Stirrup Creek Drive, Suite 110 | ||
Entity Address, City or Town | Durham, | ||
Entity Address, State or Province | NC | ||
Entity Address, Postal Zip Code | 27703 | ||
City Area Code | 919 | ||
Local Phone Number | 485-8080 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value | ||
Trading Symbol | NOVN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 188.2 | ||
Entity Common Stock, Shares Outstanding (in shares) | 18,815,892 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001467154 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Name | BDO USA, LLP |
Auditor Location | Raleigh, North Carolina |
Auditor Firm ID | 243 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 47,085 | $ 35,879 |
Contracts and grants receivable | 4,473 | 4,863 |
Prepaid insurance | 1,697 | 1,818 |
Prepaid expenses and other current assets | 766 | 1,333 |
Other current asset related to leasing arrangement, net | 109 | 0 |
Assets held for sale | 0 | 114 |
Total current assets | 54,130 | 44,007 |
Restricted cash | 583 | 0 |
Intangible assets | 75 | 75 |
Other assets | 278 | 341 |
Property and equipment, net | 12,201 | 2,406 |
Right-of-use lease assets | 1,693 | 0 |
Total assets | 68,960 | 46,829 |
Current liabilities: | ||
Accounts payable | 2,170 | 1,192 |
Accrued compensation | 1,543 | 1,154 |
Accrued outside research and development services | 194 | 930 |
Accrued legal and professional fees | 427 | 168 |
Other accrued expenses | 2,824 | 801 |
Deferred revenue, current portion | 2,586 | 2,990 |
Paycheck Protection Program loan, current portion | 0 | 478 |
Research and development service obligation liability, current portion | 1,406 | 987 |
Total current liabilities | 11,150 | 8,700 |
Deferred revenue, net of current portion | 10,665 | 8,238 |
Paycheck Protection Program loan, net of current portion | 0 | 478 |
Operating lease liabilities, net of current portion | 3,613 | 0 |
Research and development service obligation liability, net of current portion | 142 | 649 |
Research and development funding arrangement liability | 25,000 | 25,000 |
Other long-term liabilities | 71 | 787 |
Total liabilities | 50,641 | 43,852 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity | ||
Common stock $0.0001 par value; 200,000,000 shares authorized as of December 31, 2021 and 2020; 18,816,842 and 14,570,959 shares issued as of December 31, 2021 and 2020, respectively; 18,815,892 and 14,570,009 shares outstanding as of December 31, 2021 and 2020, respectively | 2 | 1 |
Additional paid-in-capital | 297,441 | 252,408 |
Treasury stock at cost, 950 shares as of December 31, 2021 and 2020 | (155) | (155) |
Accumulated deficit | (278,969) | (249,277) |
Total stockholders’ equity | 18,319 | 2,977 |
Total liabilities and stockholders’ equity | $ 68,960 | $ 46,829 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 18,816,842 | 14,570,959 |
Common stock, shares outstanding (in shares) | 18,815,892 | 14,570,009 |
Treasury stock, shares (in shares) | 950 | 950 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenue | $ 2,958 | $ 4,920 |
Operating expenses: | ||
Research and development | 20,416 | 19,814 |
General and administrative | 12,343 | 11,271 |
Impairment loss on long-lived assets | 114 | 2,277 |
Loss on facility asset group disposition | 0 | 1,772 |
Total operating expenses | 32,873 | 35,134 |
Operating loss | (29,915) | (30,214) |
Other (expense) income, net: | ||
Interest income | 13 | 51 |
Gain on debt extinguishment | 956 | 0 |
Other (expense) income | (746) | 870 |
Total other (expense) income, net | 223 | 921 |
Net loss | (29,692) | (29,293) |
Comprehensive loss | $ (29,692) | $ (29,293) |
Net loss per share, basic (in USD per share) | $ (1.74) | $ (2.96) |
Net loss per share, diluted (in USD per share) | $ (1.74) | $ (2.96) |
Weighted-average common shares outstanding, basic (in shares) | 17,065,932 | 9,880,812 |
Weighted-average common shares outstanding, diluted (in shares) | 17,065,932 | 9,880,812 |
License and collaboration revenue | ||
License and collaboration revenue | $ 2,822 | $ 4,208 |
Government research contracts and grants revenue | ||
Government research contracts and grants revenue | $ 136 | $ 712 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Public Offering | Common Stock Purchase Agreement | Pre Funded WarrantPublic Offering | Pre Funded WarrantRegistered Direct Offering | Common Warrant | Common Stock | Common StockPublic Offering | Common StockCommon Stock Purchase Agreement | Common StockPre Funded WarrantPublic Offering | Common StockPre Funded WarrantRegistered Direct Offering | Common StockCommon Warrant | Additional Paid-In Capital | Additional Paid-In CapitalPublic Offering | Additional Paid-In CapitalCommon Stock Purchase Agreement | Additional Paid-In CapitalPre Funded WarrantPublic Offering | Additional Paid-In CapitalPre Funded WarrantRegistered Direct Offering | Additional Paid-In CapitalCommon Warrant | Treasury Stock | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 2,673,480 | |||||||||||||||||||
Beginning balance at Dec. 31, 2019 | $ (22,283) | $ 0 | $ 197,856 | $ (155) | $ (219,984) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Stock-based compensation | 991 | 991 | ||||||||||||||||||
Common stock issued during period (in shares) | 6,205,804 | 1,549,860 | 1,055,000 | |||||||||||||||||
Common stock issued during period | $ 35,636 | $ 5,158 | $ 7,225 | $ 1 | $ 35,636 | $ 5,158 | $ 7,224 | |||||||||||||
Exercise of warrants (in shares) | 433,333 | 805,465 | 1,845,917 | |||||||||||||||||
Exercise of common stock warrants | $ 5,538 | $ 5,538 | ||||||||||||||||||
Net loss | $ (29,293) | (29,293) | ||||||||||||||||||
Exercise of stock options (in shares) | 1,150 | 1,150 | ||||||||||||||||||
Exercise of stock options | $ 5 | 5 | ||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 14,570,009 | |||||||||||||||||||
Ending balance at Dec. 31, 2020 | 2,977 | $ 1 | 252,408 | (155) | (249,277) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Stock-based compensation | 941 | 941 | ||||||||||||||||||
Common stock issued during period (in shares) | 3,636,364 | 493,163 | ||||||||||||||||||
Common stock issued during period | $ 37,236 | $ 1 | $ 37,236 | $ 6,333 | ||||||||||||||||
Exercise of warrants (in shares) | 103,551 | |||||||||||||||||||
Exercise of common stock warrants | $ 461 | $ 461 | ||||||||||||||||||
Net loss | $ (29,692) | (29,692) | ||||||||||||||||||
Extinguishment of fractional shares resulting from reverse stock split (in shares) | (37) | |||||||||||||||||||
Exercise of stock options (in shares) | 12,842 | 12,842 | ||||||||||||||||||
Exercise of stock options | $ 62 | 62 | ||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2021 | 18,815,892 | |||||||||||||||||||
Ending balance at Dec. 31, 2021 | $ 18,319 | $ 2 | $ 297,441 | $ (155) | $ (278,969) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flow from operating activities: | ||
Net loss | $ (29,692) | $ (29,293) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 344 | 1,170 |
Impairment loss on long-lived assets | 114 | 2,277 |
Non-cash loss on facility asset group disposition | 0 | 767 |
Stock-based compensation | 275 | 1,308 |
Non-cash cost of shares issued to Aspire Capital as commitment fee | 0 | 1,695 |
Foreign currency transaction loss | 820 | 0 |
Gain on debt extinguishment | (956) | 0 |
Loss on disposal and write-offs of property and equipment | 0 | 66 |
Changes in operating assets and liabilities: | ||
Contracts and grants receivable | 47 | (4,444) |
Prepaid insurance, prepaid expenses and other current assets | 688 | (1,548) |
Accounts payable | 544 | (427) |
Accrued compensation | 389 | 717 |
Accrued outside research and development services | (736) | (83) |
Accrued legal and professional fees | 259 | (448) |
Other accrued expenses | 1,377 | (38) |
Deferred revenue | 1,525 | (276) |
Research and development service obligation liability | (88) | (2,179) |
Other long-term assets and liabilities | 313 | (324) |
Net cash used in operating activities | (24,777) | (31,060) |
Cash flow from investing activities: | ||
Purchases of property and equipment | (9,050) | (648) |
Landlord reimbursement of tenant improvement allowance | 1,523 | 0 |
Proceeds from the sale of property and equipment | 0 | 522 |
Net cash used in investing activities | (7,527) | (126) |
Cash flow from financing activities: | ||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | 37,600 | 12,577 |
Proceeds from exercise of common stock warrants | 461 | 5,538 |
Proceeds from Paycheck Protection Program loan | 0 | 956 |
Proceeds from issuance of common stock under common stock purchase agreement | 6,334 | 33,941 |
Payments related to public offering costs | (364) | (178) |
Payments of offering costs related to new registration statement | 0 | (25) |
Proceeds from exercise of stock options | 62 | 5 |
Net cash provided by financing activities | 44,093 | 52,814 |
Net increase in cash, cash equivalents and restricted cash | 11,789 | 21,628 |
Cash, cash equivalents and restricted cash as of beginning of period | 35,879 | 14,251 |
Cash, cash equivalents and restricted cash as of end of period | 47,668 | 35,879 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 0 | 0 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Deferred offering costs reclassified to additional paid-in capital | 364 | 16 |
Purchases of property and equipment with accounts payable and accrued expenses | 1,471 | 382 |
Right-of-use assets obtained in exchange for lease liabilities | 1,693 | 0 |
Non-cash gain on debt extinguishment from forgiveness of Paycheck Protection Program loan | 956 | 0 |
Reconciliation to consolidated balance sheets: | ||
Cash and cash equivalents | 47,085 | 35,879 |
Restricted cash | 583 | 0 |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 47,668 | $ 35,879 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Organization and Significant Accounting Policies | Organization and Significant Accounting Policies Business Description and Basis of Presentation Novan, Inc. (“Novan” and together with its subsidiaries, the “Company”), is a North Carolina-based pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies. The Company leverages its proprietary nitric oxide based technology platform, Nitricil™, to generate macromolecular new chemical entities. Novan was incorporated in January 2006 under the state laws of Delaware. Its wholly-owned subsidiary, Novan Therapeutics, LLC was organized in 2015 under the state laws of North Carolina. On March 14, 2019, the Company completed registration of a wholly-owned Ireland-based subsidiary, Novan Therapeutics, Limited. The accompanying consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Additionally, the report of the Company’s independent registered public accounting firm (PCAOB ID #243) on the Company’s consolidated financial statements as of and for the year ended December 31, 2021, included an explanatory paragraph indicating that there is substantial doubt about the Company’s ability to continue as a going concern, as further discussed below. Basis of Consolidation The accompanying consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Reverse Stock Split On May 25, 2021, the Company amended its restated certificate of incorporation effecting a 1-for-10 reverse stock split of its outstanding shares of capital stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of capital stock of the Company or cause an adjustment to the par value of the Company's capital stock. As a result of the Reverse Stock Split, the Company adjusted (i) the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, warrants to purchase shares of common stock and stock appreciation rights, (ii) the share price targets of the Company’s Tangible Stockholder Return Plan and (iii) the number of shares reserved for issuance pursuant to the Company’s equity incentive compensation plans. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who would have otherwise held a fractional share of capital stock received a cash payment for any fractional share resulting from the Reverse Stock Split in an amount equal to such fraction multiplied by the closing sales price of the common stock as reported on the Nasdaq Stock Market on May 25, 2021, the last trading day immediately prior to the effectiveness of the Reverse Stock Split. See Note 10—Stockholders’ Equity (Deficit) for further information regarding the Reverse Stock Split. All disclosures of shares and per share data in the consolidated financial statements and related notes have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented, and certain amounts within the consolidated balance sheets and consolidated statements of stockholders’ equity (deficit) were reclassified between common stock and additional paid-in capital. Liquidity and Ability to Continue as a Going Concern The Company’s consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern. The Company has evaluated principal conditions and events, in the aggregate, that may raise substantial doubt about its ability to continue as a going concern within one year from the date that these financial statements are issued. The Company identified the following conditions: • The Company has reported a net loss in all fiscal periods since inception and, as of December 31, 2021, the Company had an accumulated deficit of $278,969. • As of December 31, 2021, the Company had a total cash and cash equivalents balance of $47,085. • As described in Note 10—Stockholders’ Equity (Deficit), in June 2021 the Company completed a public offering of its common stock pursuant to the Company’s shelf registration statement (the “June 2021 Public Offering”). Net proceeds from the offering were approximately $37,236 after deducting underwriting discounts and commissions and offering expenses of approximately $2,764. • As described in Note 10—Stockholders’ Equity (Deficit), in July 2020 the Company entered into a common stock purchase agreement (the “July 2020 Aspire CSPA”) with Aspire Capital Fund, LLC (“Aspire Capital”). The July 2020 Aspire CSPA replaced the prior common stock purchase agreement, dated as of June 15, 2020, between the Company and Aspire Capital (the “June 2020 Aspire CSPA”), which was fully utilized. During the year ended December 31, 2021, the Company received aggregate net proceeds of $6,334 from sales under the July 2020 Aspire CSPA and, as of December 31, 2021, had $12,005 in remaining availability for sales of its common stock under the July 2020 Aspire CSPA, subject to certain limitations. • The Company anticipates that it will continue to generate losses for the foreseeable future, and it expects the losses to increase as it continues the development of, and seeks regulatory approvals for, its product candidates and begins activities to prepare for potential commercialization. • The Company has concluded that the prevailing conditions and ongoing liquidity risks faced by the Company, coupled with its current forecasts, including costs associated with implementing the SB206 prelaunch strategy and commercial preparation, raise substantial doubt about its ability to continue as a going concern. This evaluation is also based on other relevant conditions that are known or reasonably knowable at the date that the financial statements are issued, including ongoing liquidity risks faced by the Company, the Company’s conditional and unconditional obligations due or anticipated within one year, the funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows, and other conditions and events that, when considered in conjunction with the above, may adversely affect the Company’s ability to meet its obligations. The Company will continue to evaluate this going concern assessment in connection with the preparation of its quarterly and annual financial statements based upon relevant facts and circumstances, including but not limited to, its cash and cash equivalents balance and its operating forecast and related cash projection. Based on the Company’s operating forecast, it believes that its existing cash and cash equivalents balance as of December 31, 2021, plus expected contractual payments to be received in connection with existing licensing agreements, will not provide it with adequate liquidity for one year from the date of the issuance of the consolidated financial statements. This operating forecast and related cash projection includes: (i) costs associated with preparing for and seeking U.S. regulatory approval of SB206 as a treatment for molluscum, including costs to prepare for a pre-NDA meeting with the FDA and NDA-enabling drug stability studies for SB206; (ii) costs associated with the completion and readiness of its new corporate headquarters and manufacturing capability necessary to support small-scale drug substance and drug product manufacturing; (iii) conducting drug manufacturing activities with external third-party contract manufacturing organizations (“CMOs”), including a drug delivery device technology enhancement project; (iv) developmental and regulatory activities for its SB019 program (Coronaviridae (COVID-19)), including a Phase 1 study, targeted for conduct in 2022; (v) preparatory activities for a potential Phase 3 study, targeted for initiation in 2023, related to SB204 as a treatment for acne; and (vi) initial efforts to support potential commercialization of SB206, but excludes: (a) any potential costs associated with other late-stage clinical programs, including executing the potentially registrational Phase 3 study of SB204 for acne; (b) progression of the SB019 program subsequent to execution of a Phase 1 study; (c) operating costs that could occur between a potential NDA submission for SB206 through NDA approval, specifically including marketing and commercialization efforts to achieve potential launch of SB206; and (d) proceeds from any potential future sales of common stock under the July 2020 Aspire CSPA. The Company may decide to revise its development and operating plans or the related timing, depending on information it learns through its research and development activities, including regulatory submission efforts related to SB206, potential commercialization strategies, the impact of outside factors such as the COVID-19 pandemic, its ability to enter into strategic arrangements or other transactions, its ability to access additional capital and its financial priorities. The Company will need significant additional funding to continue its operating activities, make further advancements in its product development programs and potentially commercialize any of its product candidates beyond those activities currently included in its operating forecast and related cash projection. The Company does not currently have sufficient funds to commercialize any of its product candidates, if approved, and its funding needs will largely be determined by its commercialization strategy for SB206, subject to NDA submission timing and the regulatory approval process. The Company has engaged Syneos Health, a fully integrated biopharmaceutical solutions organization, as its commercial solutions provider for SB206. The Company’s relationship with Syneos Health will focus on implementing the SB206 prelaunch strategy and commercial preparation, if approved by the U.S. Food and Drug Administration. The inability of the Company to obtain significant additional funding on acceptable terms, including through the utilization of the remaining amount available under the July 2020 Aspire CSPA, could have a material adverse effect on the Company’s business and cause the Company to alter or reduce its planned operating activities, including but not limited to delaying, reducing, terminating or eliminating planned product candidate development activities, to conserve its cash and cash equivalents. The Company may pursue additional capital through equity or debt financings, including potential sales under the July 2020 Aspire CSPA, or from non-dilutive sources, including partnerships, collaborations, licensing, grants or other strategic relationships. The Company’s anticipated expenditure levels may change if it adjusts its current operating plan. Such actions could delay development timelines and have a material adverse effect on its business, results of operations, financial condition and market valuation. The Company’s equity issuances during the year ended December 31, 2021 and 2020, have resulted in significant dilution to its existing stockholders. Any future additional issuances of equity, or debt convertible into equity, would result in further significant dilution to the Company’s existing stockholders. As of December 31, 2021 the Company had 18,815,892 shares of common stock outstanding. In addition, as of December 31, 2021, the Company had reserved 3,065,953 shares of common stock for future issuance related to (i) outstanding warrants to purchase common stock; (ii) outstanding stock options and stock appreciation rights; and (iii) future issuance under the 2016 Incentive Award Plan. As of December 31, 2021, the Company’s common stock consists of 200,000,000 authorized shares. The Company is also exploring the potential for strategic transactions, such as strategic acquisitions or in-licenses, sales or divestitures of some of its assets, or other potential strategic transactions, which could include a sale of the Company. If the Company were to pursue such a transaction, it may not be able to complete the transaction on a timely basis or at all or on terms that are favorable to the Company. Alternatively, if the Company is unable to obtain significant additional funding on acceptable terms or progress with a strategic transaction, it could instead determine to dissolve and liquidate its assets or seek protection under the bankruptcy laws. If the Company decides to dissolve and liquidate its assets or to seek protection under the bankruptcy laws, it is unclear to what extent the Company will be able to pay its obligations, and, accordingly, it is further unclear whether and to what extent any resources will be available for distributions to stockholders. COVID-19 In December 2019, the novel strain of a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), which causes novel coronavirus disease (“COVID-19”) was reported in China, and in March 2020, the World Health Organization declared it a pandemic. The extent to which COVID-19, and its variant strains, and domestic and global efforts to contain its spread will impact the Company’s business including its operations, preclinical studies, clinical trials, and financial condition will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity and scope of the pandemic, the availability and effectiveness of vaccines in preventing the spread of COVID-19 (and its variants), and the actions taken by other parties, such as governmental authorities, to contain and treat COVID-19 and its variants. During the pandemic, the timetable for development of the Company’s product candidates has been impacted and may face further disruption and the Company’s business could be further adversely affected by the outbreak of COVID-19 and its variants. In particular, COVID-19 impacted the timing of trial initiation of the Company’s B-SIMPLE4 Phase 3 study and is one factor influencing the Company’s adjustment of its targeted SB206 submission timing, planned no later than the fourth quarter of 2022. The Company previously articulated a targeted NDA submission of SB206 during the third quarter of 2022, however, due to factors including supply chain constraints, impacts of the COVID-19 pandemic, certain manufacturing related equipment issues and scheduling challenges, both within the Company’s corporate facility and with third-party CMOs, it has adjusted its expected timing accordingly. The Company continues to assess any further impact of COVID-19 on its operations. In addition, the Company currently relies on third parties in connection with sourcing the raw materials used in the manufacture of its product candidates, transporting certain materials relating to its product candidates and manufacturing drug product. The Company continues to assess any further impact of COVID-19 on its supply chain and related vendors, and the impact of global supply chain constraints across various industries, including interruption of, or delays in receiving supplies of raw materials, active pharmaceutical ingredient (“API”) or drug product from third-party manufacturers due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems. The Company is also continuing to evaluate the impacts of COVID-19 and global supply chain constraints on its work to commission its new facility. The Company expects to complete the commissioning and validation of its new facility to support various research and development and current good manufacturing practice (“cGMP”), activities, including small-scale manufacturing capabilities for API and drug product, by the end of the first half of 2022. The extent to which COVID-19 and its variants may impact the Company’s financial condition or results of operations in the future is uncertain. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from these estimates. Reclassifications Certain amounts in the Company’s consolidated balance sheet as of December 31, 2020 have been reclassified to conform to current presentation related to deferred offering costs in the amount of $58 being included with prepaid expenses and other current assets. These reclassifications had no impact on the Company’s consolidated current assets or on the consolidated statements of operations and comprehensive loss or cash flows for the year ended December 31, 2020. Certain amounts in the Company’s consolidated balance sheet as of December 31, 2020 have been reclassified to conform t o current presentation related to the May 25, 2021 Reverse Stock Split. The reclassified amount between common stock and additional paid-in capital was $13 as of December 31, 2020. These reclassifications had no impact on the Company’s consolidated stockholders’ equity or on the consolidated statements of operations and comprehensive loss or cash flows for the year ended December 31, 2020. Immaterial Revision During the course of preparing the Company’s consolidated financial statements as of and for the year ended December 31 2021, the Company completed an Internal Revenue Code Section 382 and 383 analysis of its historical net operating loss and tax credit carryforward amounts. As a result, a portion of the prior year net operating loss and tax credit carryforwards were determined to be limited. See Note 13—Income Taxes, for further details. Cash and Cash Equivalents The Company considers all highly liquid instruments purchased with a maturity of three months or less to be cash equivalents. Cash and cash equivalents include deposits and money market accounts. Restricted Cash Restricted cash as of December 31, 2021 includes funds maintained in a deposit account to secure a letter of credit for the benefit of the New Landlord (as defined below). See Note 8—Commitments and Contingencies for further information regarding the letter of credit and the New Lease (as defined below). Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist principally of cash and cash equivalents. The Company places its cash and cash equivalents with financial institutions and these deposits may at times be in excess of insured limits. Contracts and Grants Receivable The Company carries its contracts and grants receivable net of an allowance for doubtful accounts. All receivables or portions thereof that are deemed to be uncollectible or that require excessive collection costs are written off to the allowance for doubtful accounts when it is probable that the receivable is unrecoverable. The Company actively reviews and evaluates its contracts and grants receivable, but no allowance for doubtful accounts has been considered necessary as of December 31, 2021 or 2020. Actual results could differ from the estimates that were used. Intangible Assets Intangible assets represent the cost to obtain and register the Company’s internet domain. Indefinite-lived intangible assets are not amortized and are assessed for impairment at least annually. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives as follows: Computer and office equipment 3 years Furniture and fixtures 5-7 years Laboratory equipment 7 years Leasehold improvements are amortized over the shorter of the life of the lease or the useful life of the improvements. Expenditures for maintenance and repairs are expensed as incurred. Improvements and betterments that add new functionality or extend the useful life of an asset are capitalized. Leases for real estate often include tenant improvement allowances, which the Company assesses according to applicable accounting guidance to determine the appropriate owner, and capitalizes such tenant improvement assets accordingly. Intellectual Property The Company’s policy is to file patent applications to protect technology, inventions and improvements that are considered important to its business. Patent positions, including those of the Company, are uncertain and involve complex legal and factual questions for which important legal principles are largely unresolved. Due to the uncertainty of future value to be realized from the expenses incurred in developing the Company’s intellectual property, the cost of filing, prosecuting and maintaining internally developed patents are expensed as general and administrative costs as incurred. Leases The Company leases office space and certain equipment under non-cancelable lease agreements. The Company applies the accounting guidance in ASC 842, Leases. As such, the Company assesses all arrangements, that convey the right to control the use of property, plant and equipment, at inception, to determine if it is, or contains, a lease based on the unique facts and circumstances present in that arrangement. For those leases identified, the Company determines the lease classification, recognition, and measurement at the lease commencement date. For arrangements that contain a lease the Company: (i) identifies lease and non-lease components; (ii) determines the consideration in the contract; (iii) determines whether the lease is an operating or financing lease; and (iv) recognizes lease Right of Use (“ROU”) assets and corresponding lease liabilities. Lease liabilities are recorded based on the present value of lease payments over the expected lease term. The corresponding ROU asset is measured from the initial lease liability, adjusted by (i) accrued or prepaid rents; (ii) remaining unamortized initial direct costs and lease incentives; and (iii) any impairments of the ROU asset. The Company elected the practical expedient to not separate non-lease components from the lease components. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Variable lease expenses that are not considered fixed are expensed as incurred. Fixed and variable lease expense on operating leases is recognized within operating expenses within the accompanying consolidated statements of operations and comprehensive loss. The Company has elected the short-term lease exemption and, therefore, does not recognize an ROU asset or corresponding liability for lease arrangements with an original term of 12 months or less. The interest rate implicit in the Company’s lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Assets Held for Sale The Company generally considers assets to be held for sale when (i) the Company commits to a plan to sell the assets, (ii) the assets are available for immediate sale in their present condition, (iii) the Company has initiated an active program to locate a buyer and other actions required to complete the plan to sell the assets, (iv) consummation of the planned sale transaction is probable, (v) the assets are being actively marketed for sale at a price that is reasonable in relation to their current fair value, (vi) the transaction is expected to qualify for recognition as a completed sale, within one year, and (vii) significant changes to or withdrawal of the plan is unlikely. Following the classification of any depreciable assets within a disposal group as held for sale, the Company discontinues depreciating the asset and writes down the asset to the lower of carrying value or fair market value less cost to sell, if needed. See Note 16—Assets Held for Sale, Impairment Charges for a discussion of the Company’s application of this accounting policy. Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for an amount by which the carrying amount of the asset exceeds the fair value of the asset. As described in Note 8—Commitments and Contingencies, on July 16, 2020, the Company entered into a lease termination agreement, which provided for the early termination of the existing lease for the Company’s previous corporate headquarters and sole research, development and manufacturing facility. In contemplation of this transaction, during June 2020, the Company decommissioned the areas within the facility, as well as the associated equipment, that supported the Company’s large scale cGMP drug manufacturing capability in preparation for execution of the lease termination agreement. The performance of decommissioning activities as noted above was considered to be a triggering event that caused the Company to evaluate its long-lived assets for impairment as of June 29, 2020, principally its right of use lease asset and its property, plant and equipment, including leasehold improvements. See Note 16—Assets Held for Sale, Impairment Charges for a discussion of the Company’s evaluation of its long-lived assets for impairment. The Company also recorded an additional loss based upon Company-specific facts and circumstances associated with the July 2020 lease termination transaction during the year ended December 31, 2020. See Note 17—Asset Group Disposition for additional detail regarding the loss on the Company’s facility asset group disposition. Revenue Recognition The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers . To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contracts with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and 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. Upon occurrence of a contract modification, the Company conducts an evaluation pursuant to the modification framework in Topic 606 to determine the appropriate revenue recognition. The framework centers around key questions, including (i) whether the modification adds additional goods and services, (ii) whether those goods and services are distinct, and (iii) whether the contract price increases by an amount that reflects the standalone selling price for the new goods or services. The resulting conclusions will determine whether the modification is treated as a separate, standalone contract or if it is combined with the original contract and accounted for in that manner. In addition, some modifications are accounted for on a prospective basis and others on a cumulative catch-up basis. The Company’s agreements may contain some or all the following types of provisions or payments: Licenses of Intellectual Property : If the license of the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the estimated performance period and the appropriate method of measuring progress during the performance period for purposes of recognizing revenue. The Company re-evaluates the estimated performance period and measure of progress each reporting period and, if necessary, adjusts related revenue recognition accordingly. Milestone Payments : At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. 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 its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and collaboration revenue and earnings in the period of adjustment. Manufacturing Supply Services : Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in license and collaboration revenue when the customer obtains control of the goods, which is upon delivery. Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and 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). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. See Note 5—Revenue Recognition for information regarding the Company’s license agreements. The Company’s revenue also includes research revenue earned under contracts and grants with Federal government agencies, which relates to the research and development of its nitric oxide platform. Government research contracts and grants revenue . Under the terms of the contracts and grants awarded, the Company is entitled to receive reimbursement of its allowable direct expenses, allocated overhead, general and administrative expenses and payment of other specified amounts. Revenues from development and support activities under government research contracts and |
KNOW Bio, LLC
KNOW Bio, LLC | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
KNOW Bio, LLC | KNOW Bio, LLC On December 30, 2015, the Company completed the distribution of 100% of the outstanding member interests of KNOW Bio, LLC (“KNOW Bio”), a former wholly owned subsidiary of the Company, to Novan’s stockholders (the “Distribution”), pursuant to which KNOW Bio became an independent privately held company. KNOW Bio Technology Agreements In connection with the Distribution, the Company entered into exclusive license agreements and sublicense agreements with KNOW Bio, as described below. The agreements will continue for so long as there is a valid patent claim under the respective agreement, unless earlier terminated, and upon expiration, will continue as perpetual non-exclusive licenses. KNOW Bio has the right to terminate each such agreement, for any reason upon 90 days advance written notice to the Company. License of existing and potential future intellectual property to KNOW Bio. The Company and KNOW Bio entered into an exclusive license agreement dated December 29, 2015 (the “KNOW Bio License Agreement”). Pursuant to the terms of the KNOW Bio License Agreement, the Company granted to KNOW Bio exclusive licenses, with the right to sublicense, under certain United States and foreign patents and patent applications that were controlled by the Company as of December 29, 2015 or that became controlled by the Company between that date and December 29, 2018, directed towards nitric-oxide releasing compositions and methods of manufacturing thereof, including methods of manufacturing Nitricil compounds and other nitric oxide-based therapeutics. Sublicense of UNC and other third party intellectual property to KNOW Bio. The Company and KNOW Bio also entered into sublicense agreements dated December 29, 2015 (the “KNOW Bio Sublicense Agreements” and together with the KNOW Bio License Agreement, the “Original KNOW Bio Agreements”). Pursuant to the terms of the KNOW Bio Sublicense Agreements, the Company granted to KNOW Bio exclusive sublicenses, with the ability to further sublicense, under certain of the United States and foreign patents and patent applications exclusively licensed to the Company from the University of North Carolina at Chapel Hill (“UNC”) under the Amended, Restated and Consolidated License Agreement dated June 27, 2012, as amended (the “UNC License Agreement”), and another third party directed towards nitric oxide-releasing compositions, to develop and commercialize products utilizing the licensed technology. Under the exclusive sublicense to the UNC patents and applications (the “UNC Sublicense Agreement”), KNOW Bio is subject to the terms and conditions under the UNC License Agreement, including milestone and diligence payment obligations. However, pursuant to the terms of the UNC License Agreement, the Company is directly obligated to pay UNC any future milestones or royalties, including those resulting from actions conducted by the Company’s sublicensees, including KNOW Bio. Therefore, in the event of KNOW Bio non-performance with respect to its obligations under the UNC Sublicense Agreement, the Company would be obligated to make such payments to UNC. KNOW Bio would then become obligated to repay the Company pursuant to the UNC Sublicense Agreement, otherwise KNOW Bio would be in breach of its agreements with the Company and intellectual property rights would revert back to the Company. There were no milestone or royalty payments required during the years ended December 31, 2021 and 2020. Amendments to License and Sublicense Agreements with KNOW Bio On October 13, 2017, the Company and KNOW Bio entered into certain amendments to the Original KNOW Bio Agreements (the “KNOW Bio Amendments”). Pursuant to the terms of the KNOW Bio Amendments, the Company re-acquired from KNOW Bio exclusive, worldwide rights under certain United States and foreign patents and patent applications controlled by the Company as of December 29, 2015, and that became controlled by the Company between December 29, 2015 and December 29, 2018, directed towards nitric oxide-releasing compositions and methods of manufacturing thereof, including methods of manufacturing Nitricil compounds, and other nitric oxide-based therapeutics, to develop and commercialize products for all diagnostic, therapeutic, prophylactic and palliative uses for any disease, condition or disorder caused by certain oncoviruses (the “Oncovirus Field”). KNOW Bio also granted to the Company an exclusive license, with the right to sublicense, under any patents and patent applications which became controlled by KNOW Bio during the three-year period between December 29, 2015 and December 29, 2018 and directed towards nitric oxide-releasing compositions and methods of manufacturing thereof, including methods of manufacturing Nitricil compounds, and other nitric oxide-based therapeutics, but not towards medical devices, to develop and commercialize products for use in the Oncovirus Field. Upon execution of the KNOW Bio Amendments, in exchange for the Oncovirus Field rights, the Company paid a non-refundable upfront payment of $250. Products the Company develops in the Oncovirus Field based on Nitricil will not be subject to any further milestones, royalties or sublicensing payment obligations to KNOW Bio under the KNOW Bio Amendments. However, if the Company develops products in the Oncovirus Field that incorporate a certain nitric oxide-releasing composition specified in the KNOW Bio Amendments and (i) are covered by KNOW Bio patents or (ii) materially use or incorporate know-how of KNOW Bio or the Company related to such composition that was created between December 29, 2015 and December 29, 2018, the Company would be obligated to make the certain contingent milestone and royalty payments to KNOW Bio under the KNOW Bio Amendments. The rights granted to the Company in the Oncovirus Field in the KNOW Bio Amendments continue for so long as there is a valid patent claim under the Original KNOW Bio Agreements, and upon expiration continue on a perpetual non-exclusive basis, and are subject to the termination rights of KNOW Bio and the Company that are set forth in the Original KNOW Bio Agreements. In addition, under the KNOW Bio Amendments, KNOW Bio may terminate the rights granted to the Company in the Oncovirus Field without terminating the Original KNOW Bio Agreements. The KNOW Bio Amendments also provide a mechanism whereby either party can cause a new chemical entity (“NCE”) covered by the Original KNOW Bio Agreements to become exclusive to such party by filing an investigational new drug application (“IND”) on the NCE. An NCE that becomes exclusive to a party under this provision may not be commercialized by the other party until the later of expiration of patents covering the NCE or regulatory exclusivity covering the NCE. A party who obtains exclusivity for an NCE must advance development of the NCE pursuant to terms of the KNOW Bio Amendments in order to maintain such exclusivity; otherwise, such exclusivity will expire. The terms of the KNOW Bio Amendments were negotiated at arms-length and do not provide the Company with an ability to significantly influence KNOW Bio or its operations. |
Research and Development Licens
Research and Development Licenses | 12 Months Ended |
Dec. 31, 2021 | |
Research and Development [Abstract] | |
Research and Development Licenses | Research and Development Licenses The Company has entered into various licensing agreements with universities and other research institutions under which the Company receives the rights, and in some cases substantially all of the rights, of the inventors, assignees or co-assignees to produce and market technology protected by certain patents and patent applications. The Company’s primary license agreement is with UNC and is described in further detail within the subsection below. The counterparties to the Company’s various other licensing agreements are the University of Akron Research Foundation, Hospital for Special Surgery, Strakan International S.a.r.l., which is a licensee of the University of Aberdeen, KIPAX AB and KNOW Bio. The Company is generally required to make milestone payments based on development milestones and will be required to make royalty payments based on a percentage of future sales of covered products or a percentage of sublicensing revenue. Costs to acquire rights under license agreements and pre-commercialization milestone payments are classified as research and development expenses in the accompanying consolidated statements of operations and comprehensive loss. Research and development expense recognized in connection with the incurrence of such costs totaled zero dollars during each of the years ended December 31, 2021 and 2020. The Company is generally required by the various licensing agreements to reimburse the licensor for certain legal and other patent related costs. These costs are expensed as incurred and are classified as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. General and administrative expense recognized in connection with the incurrence of such costs totaled $137 and $103 during the years ended December 31, 2021 and 2020, respectively. These license arrangements could require the Company to make payments upon achievement of certain milestones by the Company. As future royalty payments are directly related to future revenues (either sales or sublicensing), future commitments cannot be determined. No accrual for future payments under these agreements has been recorded, as the Company cannot estimate if, when or in what amount payments may become due. UNC License Agreement The UNC License Agreement provides the Company with an exclusive license to issued patents and pending applications directed to the Company’s library of Nitricil compounds, including patents issued in the United States, Canada, Italy, Great Britain, France, Ireland, Germany, Finland, Spain, Sweden, Switzerland, Japan and Australia, with claims intended to cover NVN1000, the NCE for the Company’s current product candidates. The UNC License Agreement requires the Company to pay UNC up to $425 in regulatory and commercial milestones on a licensed product by licensed product basis and a running royalty percentage in the low single digits on net sales of licensed products. Licensed products include any products being developed by the Company or by its sublicensees. |
Licensing Arrangements
Licensing Arrangements | 12 Months Ended |
Dec. 31, 2021 | |
Collaboration Arrangements [Abstract] | |
Licensing Arrangements | Licensing Arrangements Sato License Agreement Significant Terms On January 12, 2017, the Company entered into a license agreement, and related first amendment, with Sato Pharmaceutical Co., Ltd. (“Sato”), relating to SB204, its drug candidate for the treatment of acne vulgaris in Japan (the “Sato Agreement”). Pursuant to the Sato Agreement, the Company granted to Sato an exclusive, royalty-bearing, non-transferable right and license under certain of the Company’s intellectual property rights, with the right to sublicense with the Company’s prior written consent, to develop, use and sell products in Japan that incorporate SB204 in certain topical dosage forms for the treatment of acne vulgaris, and to make the finished form of such products. On October 5, 2018, the Company and Sato entered into the second amendment (the “Sato Amendment”) to the Sato Agreement (collectively, the “Amended Sato Agreement”). The Sato Amendment expanded the Sato Agreement to include SB206, the Company’s drug candidate for the treatment of viral skin infections. Pursuant to the Amended Sato Agreement, the Company granted to Sato an exclusive, royalty-bearing, non-transferable license under certain of its intellectual property rights, with the right to sublicense with the Company’s prior written consent, to develop, use and sell products in Japan that incorporate SB204 or SB206 in certain topical dosage forms for the treatment of acne vulgaris or viral skin infections, respectively, and to make the finished form of such products. The Company or its designated contract manufacturer will supply finished product to Sato for use in the development of SB204 and SB206 in the licensed territory. The rights granted to Sato do not include the right to manufacture the API of SB204 or SB206; rather, the parties agreed to negotiate a commercial supply agreement pursuant to which the Company or its designated contract manufacturer would be the exclusive supplier to Sato of the API for the commercial manufacture of licensed products in the licensed territory. Under the terms of the Amended Sato Agreement, the Company also has exclusive rights to certain intellectual property that may be developed by Sato in the future, which the Company could choose to use for its own development and commercialization of SB204 or SB206 outside of Japan. Under the Amended Sato Agreement, in exchange for the SB204 and SB206 license rights granted to Sato, Sato agreed to pay the Company the following: • An upfront payment of 1.25 billion Japanese Yen (“JPY”), payable in installments of 0.25 billion JPY, 0.5 billion JPY and 0.5 billion JPY on October 5, 2018, February 14, 2019 and September 13, 2019, respectively. This was in addition to the 1.25 billion JPY (approximately $10,813 USD) paid on January 19, 2017 following the execution of the Sato Agreement on January 12, 2017. On October 23, 2018, the Company received the first installment from the Amended Sato Agreement of 0.25 billion JPY (approximately $2,224 USD). On March 14, 2019, the Company received the second installment payment related to the Amended Sato Agreement of 0.5 billion JPY (approximately $4,460 USD). On November 7, 2019, the Company received the third installment payment related to the Amended Sato Agreement of 0.5 billion JPY (approximately $4,554 USD). • Up to an aggregate of 1.75 billion JPY (adjusted from 2.75 billion JPY in the Sato Agreement) upon the achievement of various development and regulatory milestones, including (i) a 0.25 billion JPY (approximately $2,162 USD) milestone payment received during the fourth quarter of 2018 following Sato’s initiation of a Phase 1 trial in Japan and (ii) an aggregate of 1.0 billion JPY that becomes payable upon the earlier occurrence of specified fixed future dates or the achievement of milestone events, of which the Company received a payment of 0.5 billion JPY (approximately $4,572 USD) during the second quarter of 2021. • Up to an aggregate of 3.9 billion JPY (adjusted from 0.9 billion JPY in the Sato Agreement) upon the achievement of various commercial milestones. • A tiered royalty ranging from a mid-single digit to a low-double digit percentage (adjusted from a mid-single digit percentage in the Sato Agreement) of net sales of licensed products in the licensed territory, subject to a reduction in the royalty payments in certain circumstances. The term of the Amended Sato Agreement (and the period during which Sato must pay royalties under the amended license agreement) expires on the twentieth anniversary of the first commercial sale of a licensed product in the licensed field in the licensed territory (adjusted from the tenth anniversary of the first commercial sale in the Sato Agreement). The term of the Amended Sato Agreement may be renewed with respect to a licensed product by mutual written agreement of the parties for additional two-year periods following expiration of the initial term. All other material terms of the Sato Agreement remain unchanged by the Sato Amendment. Sato is responsible for funding the development and commercial costs for the program that are specific to Japan. The Company is obligated to perform certain oversight, review and supporting activities for Sato, including: (i) using commercially reasonable efforts to obtain marketing approval of SB204 and SB206 in the United States; (ii) sharing all future scientific information the Company may obtain during the term of the Amended Sato Agreement pertaining to SB204 and SB206; (iii) performing certain additional preclinical studies if such studies are deemed necessary by the Japanese regulatory authority, up to and not to exceed a total cost of $1,000; and (iv) participating in a joint committee that oversees, reviews and approves Sato’s development and commercialization activities under the Amended Sato Agreement. Additionally, the Company has granted Sato the option to use the Company’s trademarks in connection with the commercialization of licensed products in the licensed territory for no additional consideration, subject to the Company’s approval of such use. Royalty and Milestone Payments Purchase Agreement with Reedy Creek Investments LLC On April 29, 2019, the Company entered into a royalty and milestone payments purchase agreement (the “Purchase Agreement”) with Reedy Creek Investments LLC (“Reedy Creek”), pursuant to which Reedy Creek provided funding to the Company in an initial amount of $25,000, for the Company to use primarily to pursue the development, regulatory approval and commercialization (including through out-license agreements and other third-party arrangements) activities for SB206, a topical gel with anti-viral properties being developed as a treatment for molluscum contagiosum, and advancing programmatically such activities with respect to SB204, a once-daily, topical monotherapy being developed for the treatment of acne vulgaris, and SB414, a topical cream-based product candidate being developed for the treatment of atopic dermatitis. Pursuant to the Purchase Agreement, the Company will pay Reedy Creek ongoing quarterly payments, calculated based on an applicable percentage per product of any upfront fees, milestone payments, royalty payments or equivalent payments received by the Company pursuant to any out-license agreement for SB204, SB206 or SB414 in the United States, Mexico or Canada, net of any upfront fees, milestone payments, royalty payments or equivalent payments paid by the Company to third parties pursuant to any agreements under which the Company has in-licensed intellectual property with respect to such products in the United States, Mexico or Canada. The applicable percentage used for determining the ongoing quarterly payments, applied to amounts received directly by the Company pursuant to any out-license agreement for each product, ranges from 10% for SB206 to 20% for SB204 and SB414. However, the agreement provides that the applicable percentage for each product will be 25% for fees or milestone payments received by the Company (but not royalty payments received by the Company) until Reedy Creek has received payments under the Purchase Agreement equal to the total funding amount provided by Reedy Creek under the Purchase Agreement. If the Company decides to commercialize any product on its own following regulatory approval, as opposed to commercializing through an out-license agreement or other third-party arrangement, the Company will only be obligated to pay Reedy Creek a low single digits royalty on net sales of such products. The Company determined that the Reedy Creek Purchase Agreement is within the scope of ASC 730-20, Research and Development Arrangements . The Company concluded that there has not been a substantive and genuine transfer of risk related to the Purchase Agreement as (i) Reedy Creek has the opportunity to recover its investment regardless of the outcome of the research and development programs within the scope of the agreement (prior to commercialization of any in scope assets through potential out-licensing agreements and related potential future milestone payments); and (ii) there is a presumption that the Company is obligated to pay Reedy Creek amounts equal to its investment based on the related party relationship at the time the parties entered into the Purchase Agreement. The Purchase Agreement is a broad funding arrangement, due to (i) the multi-asset, or portfolio approach including three developmental assets that are within the scope of the arrangement; and (ii) Reedy Creek’s approximate 5% ownership of the outstanding shares of common stock of the Company at the time of entry into the Purchase Agreement. As such, the Company determined that the appropriate accounting treatment under ASC 730-20 was to record the initial proceeds of $25,000 as cash and cash equivalents, as the Company had the ability to direct the usage of funds, and a long-term liability within its classified balance sheet. The long-term liability will remain until the Company receives future milestones from other potential third parties, as defined within the Purchase Agreement, of which 25% will be contractually owed to Reedy Creek. If potential future milestones or other payments are received by the Company, and become partly due to Reedy Creek, the corresponding partial repayment to Reedy Creek will result in a ratable reduction of the total long-term obligation to repay the initial purchase price. Development Funding and Royalties Agreement with Ligand Pharmaceuticals Incorporated On May 4, 2019, the Company entered into a development funding and royalties agreement (the “Funding Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”), pursuant to which Ligand provided funding to the Company of $12,000, for the Company to use to pursue the development and regulatory approval of SB206, a topical gel with anti-viral properties being developed as a treatment for molluscum contagiosum. Pursuant to the Funding Agreement, the Company will pay Ligand up to $20,000 in milestone payments upon the achievement by the Company of certain regulatory and commercial milestones associated with SB206 or any product that incorporates or uses NVN1000, the API for the Company’s clinical stage product candidates, as a treatment for molluscum contagiosum. In addition to the milestone payments, the Company will pay Ligand tiered royalties ranging from 7% to 10% based on annual aggregate net sales of such products in the United States, Mexico or Canada. The Company determined that the Ligand transaction is within the scope of ASC 730-20 as it represents an obligation to perform contractual services for the development of SB206 using commercially reasonable efforts. In addition, the Funding Agreement also states that if all development of SB206 is ceased prior to the first regulatory approval, the Company must pay to Ligand an amount equal to the purchase price less the amount spent in accordance with the development budget on development activities conducted prior to such cessation. As such, the Company concluded that the appropriate accounting treatment under ASC 730-20 was to record the initial proceeds of $12,000, as a liability and as restricted cash on its consolidated balance sheet, as the funds could only be used for the progression of SB206. The Company amortizes the liability ratably during each reporting period, based on the Ligand funding as a percentage of the total direct costs incurred by the Company during the reporting period related to the estimated total cost to progress the SB206 program to a regulatory approval in the United States. The ratable Ligand funding is presented within the accompanying consolidated statements of operations and comprehensive loss within research and development expenses associated with the SB206 program. During the three months ended June 30, 2020, the Company completed a reassessment of the estimated total cost to progress the SB206 program to a potential United States regulatory approval, including consideration of how such estimated costs may potentially be affected by various regulatory, clinical development, and drug manufacturing and supply factors. During this reassessment, the Company concluded that the incremental costs associated with the conduct of the B-SIMPLE4 Phase 3 trial would be excluded from the total cost basis used to amortize the liability because they were not contemplated within the Funding Agreement. The reassessment also concluded that the other projected costs to progress SB206 to a planned regulatory approval in the United States, most of which are regulatory costs associated with the NDA submission process, did not materially change and did not have a material effect on the amortization of the liability. The initial restricted cash balance was also reduced ratably during interim reporting periods in 2019 in a manner consistent with the amortization method for the Ligand funding liability balance. As of December 31, 2019, the aggregate amount spent in accordance with the SB206 development budget on SB206 development activities had exceeded the $12,000 purchase price, causing the aforementioned repayment provision provided for in the Funding Agreement to no longer be enforceable. Therefore, the Company reported no restricted cash balance related to the Funding Agreement, as of December 31, 2021 or 2020 in its accompanying consolidated balance sheets. For the years ended December 31, 2021 and 2020, the Company recorded $88 and $2,179 of amortization, respectively, within contra-research and development expense related to the SB206 developmental program, funded by Ligand. During the year ended December 31, 2021, after the announcement of the B-SIMPLE4 positive top-line results on June 11, 2021, the Company reassessed and identified additional estimated costs necessary to progress the SB206 program to a potential United States regulatory approval. As such, the estimated regulatory costs subject to the Ligand funding have increased from prior periods. The Company will continue to monitor and adjust its estimated regulatory costs, through approval, as needed. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition Sato Agreement The Company assessed the Sato Agreement in accordance with Topic 606 and concluded that the contract counterparty, Sato, is a customer within the scope of Topic 606. The Company identified the following promises under the Sato Agreement: (i) the grant of the intellectual property license to Sato; (ii) the obligation to participate in a joint committee that oversees, reviews, and approves Sato’s research and development activities and provides advisory support during Sato’s development process; (iii) the obligation to manufacture and supply Sato with all quantities of licensed product required for development activities in Japan; and (iv) the stand-ready obligation to perform any necessary repeat preclinical studies, up to $1,000 in cost. The Company determined that these promises were not individually distinct because Sato can only benefit from these licensed intellectual property rights and services when bundled together; they do not have individual benefit or utility to Sato. As a result, all promises have been combined into a single performance obligation. The Sato Agreement also provides that the two parties agree to negotiate in good faith the terms of a commercial supply agreement pursuant to which the Company or a third-party manufacturer would be the exclusive supplier to Sato of the API for the commercial manufacture of licensed products in the licensed territory. The Company concluded this obligation to negotiate the terms of a commercial supply agreement does not create (i) a legally enforceable obligation under which the Company may have to perform and supply Sato with API for commercial manufacturing; or (ii) a material right because the incremental commercial supply fee consideration framework in the Sato Agreement is representative of a stand-alone selling price for the supply of API and does not represent a discount. Therefore, this contract provision is not considered to be a promise to deliver goods or services and is not a performance obligation or part of the combined single performance obligation described above. Amended Sato Agreement On October 5, 2018, the Company and Sato entered into the Amended Sato Agreement. The Sato Amendment expanded the Sato Agreement to include SB206, the Company’s drug candidate for the treatment of viral skin infections. The Company assessed the Amended Sato Agreement in accordance with Topic 606 and concluded the contract modification should incorporate the additional goods and services provided for in the Amendment into the existing, partially satisfied single bundled performance obligation that will continue to be delivered to Sato over the remaining development period. This contract modification accounting is concluded to be appropriate as the additional goods and services conveyed under the Sato Amendment were determined to not be distinct from the single performance obligation, and the additional consideration provided did not reflect the standalone selling price of those additional goods and services. As such, the Company recorded a cumulative adjustment as of the amendment execution date to reflect revenue that would have been recognized cumulatively for the partially completed bundled performance obligation. The Company concluded that the following consideration would be included in the transaction price as they were (i) received prior to December 31, 2021, or (ii) payable upon specified fixed dates in the future and are not contingent upon clinical or regulatory success in Japan: • The 1.25 billion JPY (approximately $10,813 USD) original upfront payment received on January 19, 2017 following the execution of the Sato Agreement on January 12, 2017. • A milestone payment of 0.25 billion JPY (approximately $2,162 USD) received during the fourth quarter of 2018 following Sato’s initiation of a Phase 1 trial in Japan. • The Sato Amendment upfront payment of 1.25 billion JPY, payable in installments of 0.25 billion JPY, 0.5 billion JPY and 0.5 billion JPY on October 5, 2018, February 14, 2019 and September 13, 2019, respectively. On October 23, 2018, the Company received the first installment from the Amended Sato Agreement of 0.25 billion JPY (approximately $2,224 USD). On March 14, 2019, the Company received the second installment payment related to the Amended Sato Agreement of 0.5 billion JPY (approximately $4,460 USD). On November 7, 2019, the Company received the third installment payment related to the Amended Sato Agreement of 0.5 billion JPY (approximately $4,554 USD). • An aggregate of 1.0 billion JPY in non-contingent milestone payments that become payable upon the earlier occurrence of specified fixed dates in the future or the achievement of specified milestone events. On May 20, 2021, the Company received one such non-contingent milestone payment in the form of a payment of 0.5 billion JPY (approximately $4,572 USD) related to achievement of a time-based developmental milestone. The payment terms contained within the Amended Sato Agreement related to upfront, developmental milestone and sales milestone payments are of a short-term nature and, therefore, do not represent a financing component requiring additional consideration. The following table presents the Company’s contract assets and contract liabilities balances for the periods indicated. Contract Asset Contract Liability Net Deferred Revenue December 31, 2020 $ 4,843 $ 16,071 $ 11,228 December 31, 2021 $ — $ 13,251 $ 13,251 Short-term Deferred Revenue Long-term Deferred Revenue Net Deferred Revenue December 31, 2020 $ 2,990 $ 8,238 $ 11,228 December 31, 2021 $ 2,586 $ 10,665 $ 13,251 The Company has recorded the Sato Agreement and Amended Sato Agreement transaction price, including the upfront payments received and the unconstrained variable consideration, as deferred revenue (comprised of (i) a contract liability; net of (ii) a contract asset). The change in the net deferred revenue balance during the year ended December 31, 2021 was associated with (i) the recognition of license and collaboration revenue associated with the Company’s performance during the period (continued amortization of deferred revenue); (ii) the impact of foreign currency exchange rate fluctuations; and (iii) a time-based developmental milestone payment that became due and payable as of December 31, 2021. This time-based milestone payment represented a contract asset as of December 31, 2020 where as of December 31, 2021 the Company had an unconditional right to receive consideration of $4,345, based upon the passage of time. Therefore, as of December 31, 2021, the Company presented this milestone payment in contracts and grants receivable within its consolidated balance sheets. During the years ended December 31, 2021 and 2020, the Company recognized $2,822 and $4,208, respectively, in license and collaboration revenue under this agreement. During the year ended December 31, 2021, the Company recognized expense of $500 related to foreign currency adjustments related to the contract asset, presented within other (expense) income, net within the accompanying consolidated statements of operations and comprehensive loss. The Company has concluded that the above consideration is probable of not resulting in a significant revenue reversal and therefore included in the transaction price and is allocated to the single performance obligation. No other variable consideration under the Amended Sato Agreement is probable of not resulting in a significant revenue reversal as of December 31, 2021 and therefore, is currently fully constrained and excluded from the transaction price. The Company evaluated the timing of delivery for its performance obligation and concluded that a time-based input method is most appropriate because Sato is accessing and benefiting from the intellectual property and technology (the predominant items of the combined performance obligation) ratably over the duration of Sato’s estimated development period in Japan. Although the Company concluded that the intellectual property is functional rather than symbolic, the services provided under the performance obligation are provided over time. Therefore, the allocated transaction price will be recognized using a time-based input method that results in straight-line recognition over the Company’s performance period. The Company monitors and reassesses the estimated performance period for purposes of revenue recognition during each reporting period. During the third quarter of 2020, Sato prepared, and the Company reviewed, an SB206 Japanese development program timeline that supported a 7.5 year performance period estimate completing in the third quarter of 2024. The SB204 Japanese development plan and program timeline was not presented by Sato and remains under evaluation by the Company and Sato. Currently, the Company understands that the progression of the Japanese SB204 program could follow the same timeline as the Japanese SB206 program, subject to the nature of the results of Sato’s comprehensive asset developmental program, including SB206. In November of 2020, Sato determined its initial Japanese Phase 1 study for SB206 would require an amended design, including evaluation of potential lower dose strengths, to further refine dose tolerability in a subsequent Phase 1 study. Based upon (i) the need for an additional Phase 1 study; (ii) Sato’s estimated comprehensive developmental schedule for SB206, including additional post-Phase 1 clinical trials; and (iii) current and future Japanese clinical trial material manufacturing and technical transfer considerations, the Company concluded that a prospective delay in Sato’s overall SB206 Japanese development plan had occurred. The Company estimated the program timeline to be extended by 1.75 years from its previous estimate, and a corresponding extension of the performance period estimate to 9.25 years, completing in the second quarter of 2026. In late July 2021, Sato communicated an updated plan regarding its amended design for its additional Japanese Phase 1 study for SB206. The amended study design included evaluation of potential lower dose strengths, including potential further refinement in a subsequent dose tolerability study. As part of the communication regarding these Phase 1 studies, Sato also communicated an updated comprehensive timeline for the Japanese SB206 program. The updated timeline assumed that the 12% formulation is appropriate to proceed for development in Japan and is to be reassessed based on the findings of the Phase 1 study. Based upon (i) the expected timing of the additional Phase 1 study, including a subsequent dose tolerability study; (ii) Sato’s estimated comprehensive developmental schedule for SB206, including additional post-Phase 1 clinical trials; and (iii) current and future Japanese clinical trial material manufacturing and technical transfer considerations, including the manufacturing site for drug product, the Company concluded that a prospective delay in Sato’s overall SB206 Japanese development plan had occurred. The Company estimated the program timeline to be extended by 0.75 years from its previous estimate, and a corresponding extension of the performance period estimate to 10 years, completing in the first quarter of 2027. The Company understands that the progression of the Japanese SB204 program could follow the same timeline as the Japanese SB206 program, subject to the nature of the results of Sato’s comprehensive asset developmental program, including SB206. The change in estimate related to the increase in the expected duration of the combined SB204 and SB206 development program timeline that occurred in July 2021 resulted in a decrease of $34 in monthly license and collaboration revenue, as compared to amounts that would have been recorded under the previous timeline. Based on the timing of this change in estimate, beginning in the third quarter of 2021, the Company recognized a lower amount of license and collaboration revenue, as compared to the first and second quarter of 2021. Prospective periods will reflect the impact of this change in estimate that occurred in July 2021, as compared to the previous timeline, based on the current timeline and the effective difference in monthly revenue recognized under the Amended Sato Agreement. The estimated timeline remains subject to prospective reassessment and adjustment based upon Sato’s interaction with the Japanese regulatory authorities and other developmental and timing considerations. The combined SB204 and SB206 development program timeline in Japan is continuously reevaluated by Sato and the Company, and may potentially be further affected by various factors, including: (i) the analyses, assessments and decisions made by the joint development committee and the applicable regulatory authorities, which will influence and establish the combined SB204 and SB206 Japan development program plan; (ii) the remaining timeline and progression of the SB206 NDA submission in the United States, which has been and may be further impacted by the COVID-19 pandemic; (iii) the API and drug product supply chain progression, including the Company’s in-house drug manufacturing capabilities; (iv) the Company’s manufacturing technology transfer projects with third-party CMOs; and (v) a drug delivery device technology enhancement project with a technology manufacturing vendor. If the duration of the combined SB204 and SB206 development program timeline is further affected by the establishment or subsequent adjustments to, as applicable, the mutually agreed upon SB204 and SB206 development plan in the Japan territory, the Company will adjust its estimated performance period for revenue recognition purposes accordingly, as needed. Contract Costs—Amended Sato Agreement The Company has incurred certain fees and costs in the process of obtaining the Amended Sato Agreement that were payable upon contract execution and, therefore, have been recognized as other assets and amortized as general and administrative expense on a straight-line basis over the same estimated performance period being used to recognize the associated revenue. These fees are associated with the following two arrangements and are described as follows: • The Company entered into an agreement with a third party to assist the Company in exploring the licensing opportunity that led to the execution of the Sato Agreement. The Company is obligated to pay the third party a low-single-digit percentage of all upfront and milestone payments the Company receives from Sato under the Amended Sato Agreement. • The intellectual property rights granted to Sato under the Amended Sato Agreement include certain intellectual property rights which the Company has licensed from UNC. Under the UNC License Agreement described in Note 3—Research and Development Licenses, the Company is obligated to pay UNC a running royalty percentage in the low single digits on net sales of licensed products, including net sales that may be generated by Sato. Additionally, the Company is obligated to make payments to UNC that represent the portion of the Sato upfront and milestone payments that were estimated to be directly attributable to the UNC intellectual property rights included in the license to Sato. The Company has also accrued certain fees that it will pay to the third party and to UNC in the future upon receipt of non-contingent installment and milestone payments from Sato. As of December 31, 2021, the Company had recorded capitalized contract acquisition costs of $345 in prepaid expenses and other current assets and other assets, and had accrued $109 in the accompanying balance sheet. For the years ended December 31, 2021 and 2020, the Company paid fees totaling $115 and $0, respectively. Performance Obligations under the Amended Sato Agreement The net amount of existing performance obligations under long-term contracts unsatisfied as of December 31, 2021 was $13,251. The Company expects to recognize approximately 20% of the remaining performance obligations as revenue over the next 12 months, and the balance thereafter. The Company applied the practical expedient and does not disclose information about variable consideration related to sales-based or usage-based royalties promised in exchange for a license of intellectual property. This expedient specifically applied to the sales-based milestone payments that are present in the Amended Sato Agreement (3.9 billion JPY), as well as percentage-based royalty payments in the Amended Sato Agreement that are contingent upon future sales. Government Contracts and Grant Revenue The Company assessed the following federal grants in accordance with Topic 958 and concluded that both represent conditional non-exchange transactions. In August 2019, the Company received a Phase 1 federal grant of approximately $223 (the “NIH Phase 1 Grant”) from the National Institutes of Health (the “NIH”). The funds are to be used to advance formulation development of a nitric oxide-containing intravaginal gel (WH602) designed to treat high-risk human papilloma virus (“HPV”) infections that can lead to cervical intraepithelial neoplasia (“CIN”). The specific focus is to ensure the nitric oxide delivery from the gel replicates doses of nitric oxide previously demonstrated to be effective against HPV in the Company’s clinical and i n vitro studies. Revenue recognized under the NIH Phase 1 Grant was $0 and $29 during the years ended December 31, 2021 and 2020, respectively. In February 2020, following the successful progression of the NIH Phase 1 Grant, the Company was awarded a Phase 2 federal grant of approximately $997 from the NIH (the “NIH Phase 2 Grant”) that will enable the conduct of IND-enabling toxicology and pharmacology studies and other preclinical activity with respect to WH602. The NIH Phase 2 Grant funds will be received by the Company in the form of periodic cost reimbursements as the underlying research and development activities are performed. The Company may be eligible to receive additional funding as part of the NIH Phase 2 Grant, subject to availability of NIH funds and satisfactory progress of the project during the initial 12-month term. Revenue recognized under the NIH Phase 2 Grant was $126 and $168 during the years ended December 31, 2021 and 2020, respectively. In September 2019, the Company received a grant from the United States Department of Defense’s Congressionally Directed Medical Research Programs of approximately $1,113 as part of its Peer Reviewed Cancer Research Program. The grant supports the development of a non-gel formulation product candidate (WH504) designed to treat high-risk HPV infections that can lead to CIN, with well-characterized physical chemical properties suitable for intravaginal administration. In addition, the grant supports the evaluation of the effect of varying concentrations and treatment durations of berdazimer sodium (NVN1000) against HPV-18 in human raft cell culture in vitro studies. Revenue recognized under this grant was $10 and $515 during the years ended December 31, 2021 and 2020, respectively. |
Research and Development Arrang
Research and Development Arrangements | 12 Months Ended |
Dec. 31, 2021 | |
Collaboration Arrangements [Abstract] | |
Research and Development Arrangements | Licensing Arrangements Sato License Agreement Significant Terms On January 12, 2017, the Company entered into a license agreement, and related first amendment, with Sato Pharmaceutical Co., Ltd. (“Sato”), relating to SB204, its drug candidate for the treatment of acne vulgaris in Japan (the “Sato Agreement”). Pursuant to the Sato Agreement, the Company granted to Sato an exclusive, royalty-bearing, non-transferable right and license under certain of the Company’s intellectual property rights, with the right to sublicense with the Company’s prior written consent, to develop, use and sell products in Japan that incorporate SB204 in certain topical dosage forms for the treatment of acne vulgaris, and to make the finished form of such products. On October 5, 2018, the Company and Sato entered into the second amendment (the “Sato Amendment”) to the Sato Agreement (collectively, the “Amended Sato Agreement”). The Sato Amendment expanded the Sato Agreement to include SB206, the Company’s drug candidate for the treatment of viral skin infections. Pursuant to the Amended Sato Agreement, the Company granted to Sato an exclusive, royalty-bearing, non-transferable license under certain of its intellectual property rights, with the right to sublicense with the Company’s prior written consent, to develop, use and sell products in Japan that incorporate SB204 or SB206 in certain topical dosage forms for the treatment of acne vulgaris or viral skin infections, respectively, and to make the finished form of such products. The Company or its designated contract manufacturer will supply finished product to Sato for use in the development of SB204 and SB206 in the licensed territory. The rights granted to Sato do not include the right to manufacture the API of SB204 or SB206; rather, the parties agreed to negotiate a commercial supply agreement pursuant to which the Company or its designated contract manufacturer would be the exclusive supplier to Sato of the API for the commercial manufacture of licensed products in the licensed territory. Under the terms of the Amended Sato Agreement, the Company also has exclusive rights to certain intellectual property that may be developed by Sato in the future, which the Company could choose to use for its own development and commercialization of SB204 or SB206 outside of Japan. Under the Amended Sato Agreement, in exchange for the SB204 and SB206 license rights granted to Sato, Sato agreed to pay the Company the following: • An upfront payment of 1.25 billion Japanese Yen (“JPY”), payable in installments of 0.25 billion JPY, 0.5 billion JPY and 0.5 billion JPY on October 5, 2018, February 14, 2019 and September 13, 2019, respectively. This was in addition to the 1.25 billion JPY (approximately $10,813 USD) paid on January 19, 2017 following the execution of the Sato Agreement on January 12, 2017. On October 23, 2018, the Company received the first installment from the Amended Sato Agreement of 0.25 billion JPY (approximately $2,224 USD). On March 14, 2019, the Company received the second installment payment related to the Amended Sato Agreement of 0.5 billion JPY (approximately $4,460 USD). On November 7, 2019, the Company received the third installment payment related to the Amended Sato Agreement of 0.5 billion JPY (approximately $4,554 USD). • Up to an aggregate of 1.75 billion JPY (adjusted from 2.75 billion JPY in the Sato Agreement) upon the achievement of various development and regulatory milestones, including (i) a 0.25 billion JPY (approximately $2,162 USD) milestone payment received during the fourth quarter of 2018 following Sato’s initiation of a Phase 1 trial in Japan and (ii) an aggregate of 1.0 billion JPY that becomes payable upon the earlier occurrence of specified fixed future dates or the achievement of milestone events, of which the Company received a payment of 0.5 billion JPY (approximately $4,572 USD) during the second quarter of 2021. • Up to an aggregate of 3.9 billion JPY (adjusted from 0.9 billion JPY in the Sato Agreement) upon the achievement of various commercial milestones. • A tiered royalty ranging from a mid-single digit to a low-double digit percentage (adjusted from a mid-single digit percentage in the Sato Agreement) of net sales of licensed products in the licensed territory, subject to a reduction in the royalty payments in certain circumstances. The term of the Amended Sato Agreement (and the period during which Sato must pay royalties under the amended license agreement) expires on the twentieth anniversary of the first commercial sale of a licensed product in the licensed field in the licensed territory (adjusted from the tenth anniversary of the first commercial sale in the Sato Agreement). The term of the Amended Sato Agreement may be renewed with respect to a licensed product by mutual written agreement of the parties for additional two-year periods following expiration of the initial term. All other material terms of the Sato Agreement remain unchanged by the Sato Amendment. Sato is responsible for funding the development and commercial costs for the program that are specific to Japan. The Company is obligated to perform certain oversight, review and supporting activities for Sato, including: (i) using commercially reasonable efforts to obtain marketing approval of SB204 and SB206 in the United States; (ii) sharing all future scientific information the Company may obtain during the term of the Amended Sato Agreement pertaining to SB204 and SB206; (iii) performing certain additional preclinical studies if such studies are deemed necessary by the Japanese regulatory authority, up to and not to exceed a total cost of $1,000; and (iv) participating in a joint committee that oversees, reviews and approves Sato’s development and commercialization activities under the Amended Sato Agreement. Additionally, the Company has granted Sato the option to use the Company’s trademarks in connection with the commercialization of licensed products in the licensed territory for no additional consideration, subject to the Company’s approval of such use. Royalty and Milestone Payments Purchase Agreement with Reedy Creek Investments LLC On April 29, 2019, the Company entered into a royalty and milestone payments purchase agreement (the “Purchase Agreement”) with Reedy Creek Investments LLC (“Reedy Creek”), pursuant to which Reedy Creek provided funding to the Company in an initial amount of $25,000, for the Company to use primarily to pursue the development, regulatory approval and commercialization (including through out-license agreements and other third-party arrangements) activities for SB206, a topical gel with anti-viral properties being developed as a treatment for molluscum contagiosum, and advancing programmatically such activities with respect to SB204, a once-daily, topical monotherapy being developed for the treatment of acne vulgaris, and SB414, a topical cream-based product candidate being developed for the treatment of atopic dermatitis. Pursuant to the Purchase Agreement, the Company will pay Reedy Creek ongoing quarterly payments, calculated based on an applicable percentage per product of any upfront fees, milestone payments, royalty payments or equivalent payments received by the Company pursuant to any out-license agreement for SB204, SB206 or SB414 in the United States, Mexico or Canada, net of any upfront fees, milestone payments, royalty payments or equivalent payments paid by the Company to third parties pursuant to any agreements under which the Company has in-licensed intellectual property with respect to such products in the United States, Mexico or Canada. The applicable percentage used for determining the ongoing quarterly payments, applied to amounts received directly by the Company pursuant to any out-license agreement for each product, ranges from 10% for SB206 to 20% for SB204 and SB414. However, the agreement provides that the applicable percentage for each product will be 25% for fees or milestone payments received by the Company (but not royalty payments received by the Company) until Reedy Creek has received payments under the Purchase Agreement equal to the total funding amount provided by Reedy Creek under the Purchase Agreement. If the Company decides to commercialize any product on its own following regulatory approval, as opposed to commercializing through an out-license agreement or other third-party arrangement, the Company will only be obligated to pay Reedy Creek a low single digits royalty on net sales of such products. The Company determined that the Reedy Creek Purchase Agreement is within the scope of ASC 730-20, Research and Development Arrangements . The Company concluded that there has not been a substantive and genuine transfer of risk related to the Purchase Agreement as (i) Reedy Creek has the opportunity to recover its investment regardless of the outcome of the research and development programs within the scope of the agreement (prior to commercialization of any in scope assets through potential out-licensing agreements and related potential future milestone payments); and (ii) there is a presumption that the Company is obligated to pay Reedy Creek amounts equal to its investment based on the related party relationship at the time the parties entered into the Purchase Agreement. The Purchase Agreement is a broad funding arrangement, due to (i) the multi-asset, or portfolio approach including three developmental assets that are within the scope of the arrangement; and (ii) Reedy Creek’s approximate 5% ownership of the outstanding shares of common stock of the Company at the time of entry into the Purchase Agreement. As such, the Company determined that the appropriate accounting treatment under ASC 730-20 was to record the initial proceeds of $25,000 as cash and cash equivalents, as the Company had the ability to direct the usage of funds, and a long-term liability within its classified balance sheet. The long-term liability will remain until the Company receives future milestones from other potential third parties, as defined within the Purchase Agreement, of which 25% will be contractually owed to Reedy Creek. If potential future milestones or other payments are received by the Company, and become partly due to Reedy Creek, the corresponding partial repayment to Reedy Creek will result in a ratable reduction of the total long-term obligation to repay the initial purchase price. Development Funding and Royalties Agreement with Ligand Pharmaceuticals Incorporated On May 4, 2019, the Company entered into a development funding and royalties agreement (the “Funding Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”), pursuant to which Ligand provided funding to the Company of $12,000, for the Company to use to pursue the development and regulatory approval of SB206, a topical gel with anti-viral properties being developed as a treatment for molluscum contagiosum. Pursuant to the Funding Agreement, the Company will pay Ligand up to $20,000 in milestone payments upon the achievement by the Company of certain regulatory and commercial milestones associated with SB206 or any product that incorporates or uses NVN1000, the API for the Company’s clinical stage product candidates, as a treatment for molluscum contagiosum. In addition to the milestone payments, the Company will pay Ligand tiered royalties ranging from 7% to 10% based on annual aggregate net sales of such products in the United States, Mexico or Canada. The Company determined that the Ligand transaction is within the scope of ASC 730-20 as it represents an obligation to perform contractual services for the development of SB206 using commercially reasonable efforts. In addition, the Funding Agreement also states that if all development of SB206 is ceased prior to the first regulatory approval, the Company must pay to Ligand an amount equal to the purchase price less the amount spent in accordance with the development budget on development activities conducted prior to such cessation. As such, the Company concluded that the appropriate accounting treatment under ASC 730-20 was to record the initial proceeds of $12,000, as a liability and as restricted cash on its consolidated balance sheet, as the funds could only be used for the progression of SB206. The Company amortizes the liability ratably during each reporting period, based on the Ligand funding as a percentage of the total direct costs incurred by the Company during the reporting period related to the estimated total cost to progress the SB206 program to a regulatory approval in the United States. The ratable Ligand funding is presented within the accompanying consolidated statements of operations and comprehensive loss within research and development expenses associated with the SB206 program. During the three months ended June 30, 2020, the Company completed a reassessment of the estimated total cost to progress the SB206 program to a potential United States regulatory approval, including consideration of how such estimated costs may potentially be affected by various regulatory, clinical development, and drug manufacturing and supply factors. During this reassessment, the Company concluded that the incremental costs associated with the conduct of the B-SIMPLE4 Phase 3 trial would be excluded from the total cost basis used to amortize the liability because they were not contemplated within the Funding Agreement. The reassessment also concluded that the other projected costs to progress SB206 to a planned regulatory approval in the United States, most of which are regulatory costs associated with the NDA submission process, did not materially change and did not have a material effect on the amortization of the liability. The initial restricted cash balance was also reduced ratably during interim reporting periods in 2019 in a manner consistent with the amortization method for the Ligand funding liability balance. As of December 31, 2019, the aggregate amount spent in accordance with the SB206 development budget on SB206 development activities had exceeded the $12,000 purchase price, causing the aforementioned repayment provision provided for in the Funding Agreement to no longer be enforceable. Therefore, the Company reported no restricted cash balance related to the Funding Agreement, as of December 31, 2021 or 2020 in its accompanying consolidated balance sheets. For the years ended December 31, 2021 and 2020, the Company recorded $88 and $2,179 of amortization, respectively, within contra-research and development expense related to the SB206 developmental program, funded by Ligand. During the year ended December 31, 2021, after the announcement of the B-SIMPLE4 positive top-line results on June 11, 2021, the Company reassessed and identified additional estimated costs necessary to progress the SB206 program to a potential United States regulatory approval. As such, the estimated regulatory costs subject to the Ligand funding have increased from prior periods. The Company will continue to monitor and adjust its estimated regulatory costs, through approval, as needed. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment consisted of the following: December 31, 2021 2020 Computer equipment $ 58 $ 67 Furniture and fixtures 23 34 Laboratory equipment 4,134 2,930 Office equipment 177 72 Leasehold improvements 9,391 562 Property and equipment, gross 13,783 3,665 Less: Accumulated depreciation and amortization (1,582) (1,259) Total property and equipment, net $ 12,201 $ 2,406 Depreciation and amortization expense was $344 and $1,170 for the years ended December 31, 2021 and 2020, respectively. For the years ended December 31, 2021 and 2020, the Company had construction in progress amounts related to leasehold improvements of $7,485 and $562, respectively. New Facility As of December 31, 2021 and 2020, the Company had goods and services associated with the planning, design and build-out of its new facility of $451 and $17, respectively, included in accounts payable and $1,020 and $365, respectively, included in other accrued expenses in other current liabilities in the accompanying consolidated financial statements. See Note 8—Commitments and Contingencies for details regarding the new facility and related lease. Previous Facility Lease During the second quarter of 2020, the Company met the relevant criteria for reporting certain property and equipment related to its previous facility as held for sale on June 29, 2020, and as a result, the Company stopped recording depreciation expense on that date, assessed the property and equipment assets for impairment pursuant to FASB Topic 360, Property, Plant, and Equipment, and reclassified the remaining carrying value of the assets held for sale as current assets in its consolidated balance sheets as of June 30, 2020. Certain events and transactions occurred during the third quarter of 2020 that resulted in the disposition of assets and liabilities within the Company’s various disposal and asset groups, including the disposition of all assets and liabilities within the Company’s previous facility asset group on July 16, 2020 in conjunction with a lease termination transaction. See Note 8—Commitments and Contingencies for further discussion regarding the previous facility lease termination transaction. See Note 16—Assets Held for Sale, Impairment Charges for discussion regarding the impairments to property and equipment, net related to the previous facility lease. See Note 17—Asset Group Disposition for further discussion related to the disposal of previous facility lease assets. |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Lease Obligations The Company leases office space and certain equipment under non-cancelable lease agreements. In accordance with ASC 842, Leases (Topic 842), arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease, if available, otherwise at the Company’s incremental borrowing rate. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elected, and has in practice, historically combined lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. Previous Facility Lease - Hopson Road, Morrisville, North Carolina In August 2015, the Company entered into a lease agreement for approximately 51,000 rentable square feet of facility space in Morrisville, North Carolina, commencing in April 2016 (the “Previous Facility Lease”). The initial term of the Previous Facility Lease extended through June 30, 2026. The Company had an option to extend the Previous Facility Lease by five years upon completion of the initial lease term, however, the renewal period was not included in the calculation of the lease obligation. As of June 30, 2020, the Company had approximately $7,900 in remaining minimum lease payments under the Previous Facility Lease. On July 16, 2020, the Company entered into a Lease Termination Agreement (the “Termination Agreement”) with Durham Hopson, LLC (as successor-in-interest to Durham Hopson Road, LLC) (the “Landlord”), which provided for the early termination of the Previous Facility Lease, subject to certain conditions. Pursuant to the terms of the Termination Agreement, the Previous Facility Lease was terminated in connection with the Landlord entering into a lease with an unrelated third party (the “New Tenant”) for the premises in the building covered by the Previous Facility Lease (the “New Tenant Lease”), which commenced on July 16, 2020. As consideration for the early termination of the Previous Facility Lease pursuant to the Termination Agreement, the Company paid $600 to the Landlord, $539 of which was remitted through the Company’s then existing security deposit under the Previous Facility Lease to the Landlord, and $61 of which was paid in cash. In addition, pursuant to the terms of a separate and stand-alone agreement between the Company and its real estate broker, the Company incurred a broker fee of $405 upon execution of the Termination Agreement. These costs directly associated with the execution of the Termination Agreement, which totaled $1,005 in aggregate, were included as part of the loss on disposition of the Company’s facility asset group, as described in Note 16—Assets Held for Sale, Impairment Charges. In connection with the termination of the Previous Facility Lease pursuant to the Termination Agreement, the Company entered into a sublease agreement, which was effective upon the termination of the Previous Facility Lease and the commencement of the New Tenant Lease, through which the Company began to sublease from the New Tenant approximately 12,000 square feet (reduced to approximately 10,000 square feet after August 31, 2020) in the building that was covered by the Previous Facility Lease (the “Sublease”). The New Tenant and the Landlord entering into the New Tenant Lease was a condition precedent to the effectiveness of the termination of the Previous Facility Lease pursuant to the Termination Agreement, and, in connection with the termination of the Previous Facility Lease, the Landlord consented to the Sublease. The Sublease expired on March 31, 2021. The Company operated its corporate headquarters, research and development laboratories and pilot scale cGMP manufacturing activities within the Morrisville, North Carolina facility underlying the Previous Facility Lease (the “Previous Facility”) pursuant to the Sublease during the first quarter of 2021, prior to taking possession of its New Facility, described below. However, the Company decommissioned the areas within the Previous Facility, as well as the associated equipment, that supported the Company’s large scale cGMP drug manufacturing capability in preparation for execution of the Termination Agreement. The Company incurred an aggregate of approximately $300 during the year ended December 31, 2020 for these decommissioning, environmental remediation and other preparatory services to ready the Previous Facility for the execution of the Termination Agreement. These costs were included within research and development expenses in the accompanying consolidated statements of operations and comprehensive loss. In connection with the execution of the Termination Agreement and the associated performance of decommissioning activities mentioned above, the Company evaluated its long-lived assets for impairment, principally its right of use lease asset and its property, plant and equipment, including leasehold improvements. See Note 16—Assets Held for Sale, Impairment Charges for a discussion of the Company’s evaluation of its long-lived assets and the resulting impairment charges recorded during the year ended December 31, 2020. The Company also recorded an additional loss based upon Company-specific facts and circumstances associated with the July 2020 lease termination transaction during the year ended December 31, 2020. See Note 17—Asset Group Disposition for additional detail regarding the loss on the Company’s facility asset group disposition. In January 2021, the Company entered into a lease agreement for a location to serve as its new corporate headquarters and to support various cGMP activities, including research and development and small-scale manufacturing capabilities, described below. New Facility Lease - Triangle Business Center, Durham, North Carolina On January 18, 2021, the Company entered into a lease with an initial term expiring in 2032, as amended for 19,265 rentable square feet, located in Durham, North Carolina. This lease dated as of January 18, 2021, as amended (the “New Lease”), is by and between the Company and Copper II 2020, LLC (“New Landlord”), pursuant to which the Company is leasing space serving as its corporate headquarters and small-scale manufacturing site (the “New Facility” or “Premises”) located within the Triangle Business Center. The lease executed on January 18, 2021, as amended, was further amended on November 23, 2021 to expand the Premises by approximately 3,642 additional rentable square feet from 15,623 rentable square feet. The Premises serves as the Company’s new corporate headquarters and has been and continues to be prepared to support various cGMP activities, including research and development and small-scale manufacturing capabilities. These capabilities include the infrastructure necessary to support small-scale drug substance manufacturing and the ability to act as a primary, or secondary backup, component of a potential future commercial supply chain. The New Lease commenced on January 18, 2021 (the “Lease Commencement Date”). Rent under the New Lease commenced in October 2021 (the “Rent Commencement Date”). The term of the New Lease expires on the last day of the one hundred twenty-third calendar month after the Rent Commencement Date. The New Lease provides the Company with one option to extend the term of the New Lease for a period of five years, which would commence upon the expiration of the original term of the New Lease, with base rent of a market rate determined according to the New Lease; however, the renewal period was not included in the calculation of the lease obligation as the Company determined it was not reasonably certain to exercise the renewal option. The monthly base rent for the Premises is approximately $40 for months 1-10 and approximately $49 for months 11-12, per the second amendment to the primary lease. Beginning with month 13 and annually thereafter, the monthly base rent will be increased by 3%. Subject to certain terms, the New Lease provides that base rent will be abated for three months following the Rent Commencement Date. The Company is obligated to pay its pro-rata portion of taxes and operating expenses for the building as well as maintenance and insurance for the Premises, all as provided for in the New Lease. The New Landlord has agreed to provide the Company with a tenant improvement allowance in an amount not to exceed $130 per rentable square foot, totaling approximately $2,031, per the primary lease, inclusive of the first amendment, and $115 per rentable square foot, totaling $419, per the second amendment to the primary lease. The tenant improvement allowance will be paid over four equal installments corresponding with work performed by the Company. Pursuant to the terms of the New Lease, the Company delivered to the New Landlord a letter of credit in the amount of $583 as collateral for the full performance by the Company of all of its obligations under the New Lease and for all losses and damages the New Landlord may suffer as a result of any default by the Company under the New Lease. Cash funds maintained in a separate deposit account at the Company’s financial institution to fully secure the letter of credit are presented as restricted cash in non-current assets on the accompanying consolidated balance sheets. Rent expense, including both short-term and variable lease components associated with the Previous Facility Lease, Sublease, and the New Lease was $467 and $550 for the years ended December 31, 2021 and 2020, respectively. Rent expense for leases less than one year in duration was $539 and $266 for the years ended December 31, 2021 and 2020, respectively. The weighted average remaining lease term for the New Lease and weighted average discount rate for the New Lease are 10.17 years and 8.35%, respectively, as of December 31, 2021. Future minimum lease payments, net of amounts expected to be received related to the tenant improvement allowance, as of December 31, 2021 were as follows: Maturity of Lease Liabilities Operating Lease 2022 $ (448) 2023 608 2024 626 2025 645 2026 665 2027 and beyond 3,700 Total future undiscounted lease payments $ 5,796 Add: reclassification of discounted net cash inflows to other current assets $ 109 Less: imputed interest $ (2,292) Total reported lease liability $ 3,613 The table above reflects payments for an operating lease with a remaining term of one year or more, but does not include obligations for short-term leases. In addition, the net cash inflow related to the 2022 fiscal year presented above relates to the expected timing of the remaining tenant improvement allowance totaling $2,450 being funded by the New Landlord, which the Company reasonably expects to receive within the next twelve months, partially offset by expected lease payments for the corresponding period. During the year ended December 31, 2021, the Company received $1,523 related to payments as part of the total New Landlord funded tenant improvement allowance. Components of lease assets and liabilities as of December 31, 2021 were as follows: As of December 31, 2021 Leases Assets Other current asset related to leasing arrangement, net $ 109 Right-of-use lease assets 1,693 Total assets $ 1,802 Liabilities Noncurrent operating lease liabilities $ 3,613 Total lease liabilities $ 3,613 The effective discounted value of the remaining tenant improvement allowance payments, of the total tenant improvement allowance of $2,450 being funded by the New Landlord, partially offset by the expected lease payments by the Company within the next twelve months results in a net balance of $109. This net amount is presented within the consolidated balance sheets as other current asset related to leasing arrangement, net as of December 31, 2021. Furthermore, this amount is also included in long-term lease liabilities within the consolidated balance sheets as of December 31, 2021. Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. See Legal Proceedings below for further discussion of pending legal claims. The Company has entered into, and expects to continue to enter into, contracts in the normal course of business with various third parties who support its clinical trials, preclinical research studies and other services related to its development activities, including drug substance and drug product manufacturing technical transfer capabilities, production and supportive costs. The scope of the services under these agreements can generally be modified at any time, and these agreements can generally be terminated by either party after a period of notice and receipt of written notice. There have been no material contract terminations as of December 31, 2021. As of December 31, 2021, the Company had accrued technical transfer capabilities and production costs of $1,072 related to external third-party CMOs included in other accrued expenses in other current liabilities in the accompanying consolidated financial statements. There were no accrued technical transfer capabilities and production costs in other accrued expenses in other current liabilities in the accompanying consolidated financial statements for the year ended December 31, 2020. See Note 3—Research and Development Licenses regarding the Company’s research and development license agreements. See Note 6—Research and Development Arrangements regarding the Purchase Agreement with Reedy Creek and the Funding Agreement with Ligand. See Note 10—Stockholders’ Equity (Deficit) regarding outstanding warrants relating to the January 2018 Public Offering, the March 2020 Public Offering and the March 2020 Registered Direct Offering. Development Services Agreement In July 2021, the Company entered into a development services agreement with a third-party full-scale API manufacturer for certain manufacturing process feasibility services including process familiarization, safety assessments, preliminary engineering studies, and initial process and analytical methods determination. Following the successful completion of certain preliminary activities with this third-party API manufacturer and other preparatory activities, the Company would then plan to proceed with the third-party API manufacturer beyond the initial stages noted above, in which case the Company expects to incur substantial costs associated with technical transfer efforts, capital expenditures, manufacturing capabilities, and certain quantities of its drug substance. Legal Proceedings The Company is not currently a party to any material legal proceedings and is not aware of any claims or actions pending against the Company that the Company believes could have a material adverse effect on the Company’s business, operating results, cash flows or financial statements. In the future, the Company might from time to time become involved in litigation relating to claims arising from its ordinary course of business. Compensatory Obligations See Note 11—Stock-Based Compensation regarding the Stock Appreciation Rights granted in January 2020. |
Paycheck Protection Program
Paycheck Protection Program | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Paycheck Protection Program | Paycheck Protection Program On April 22, 2020, the Company entered into a promissory note, which was subsequently amended (the “Note”), evidencing an unsecured loan in the amount of approximately $956 made to the Company (the “Loan”) under the Paycheck Protection Program (the “PPP”). The PPP was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the United States Small Business Administration (the “SBA”). The Loan was made through PNC Bank, National Association. Subject to the terms of the Note, the Loan’s interest rate was fixed at one percent (1%) per annum. Under the terms of the CARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a portion of loans granted under the PPP, with such forgiveness to be determined, subject to limitations, based on the use of loan proceeds for payment of permitted and program-eligible expenses. Interest payable on the Note may be forgiven only if the SBA agrees to pay such interest on the forgiven principal amount of the Note. The Company previously applied for and during the second quarter of 2021 received notification of forgiveness of the entire loan balance, including any accrued interest. Based upon the Notice of Paycheck Protection Program Forgiveness Payment received by the Company from the SBA, as of June 14, 2021, the forgiveness of the principal balance of $956 is presented within the consolidated statements of operations and comprehensive loss as a gain on debt extinguishment. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders’ Equity (Deficit) Capital Structure In conjunction with the completion of the Company’s initial public offering in September 2016, the Company amended its restated certificate of incorporation and amended and restated its bylaws. The amendment provided for 210,000,000 authorized shares of capital stock, of which 200,000,000 shares are designated as $0.0001 par value common stock and 10,000,000 shares are designated as $0.0001 par value preferred stock. At the Company’s Annual Meeting of Stockholders held on July 28, 2020 (the “2020 Annual Meeting”), the Company’s stockholders approved an amendment to the Company’s restated certificate of incorporation of the Company to effect a reverse stock split of the Company’s common stock at a ratio of not less than one-for-two and not more than one-for-fifteen, with such ratio and the implementation and timing of such reverse stock split to be determined by the Company’s board of directors in its sole discretion. On May 18, 2021, the Company’s board of directors approved a one-for-ten reverse stock split of the Company’s issued and outstanding common stock. On May 24, 2021, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to the Restated Certification of Incorporation of the Company in order to effect the Reverse Stock Split. The Reverse Stock Split became effective as of 5:00 p.m. Eastern Time on May 25, 2021, and the Company’s common stock began trading on a split-adjusted basis on May 26, 2021. As a result of the Reverse Stock Split, on the effective date thereof, each outstanding ten (10) shares of common stock combined into and became one (1) share of common stock, and the number of the Company’s issued and outstanding shares of common stock was reduced to 15,170,678. The accompanying consolidated financial statements and related notes give retroactive effect to the Reverse Stock Split. June 2021 Public Offering On June 17, 2021, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co., as underwriter, pursuant to which the Company agreed to issue and sell an aggregate of 3,636,364 shares of the Company’s common stock at a price to the public of $11.00 per share, less underwriting discounts and commissions. The Company also granted the underwriter a 30-day option (the “Underwriter Option”) to purchase up to an additional 545,454 shares of common stock at the public offering price, less underwriting discounts and commissions. The June 2021 Public Offering closed on June 21, 2021, and the Underwriter Option expired unexercised in July 2021. Net proceeds from the June 2021 Public Offering were approximately $37,236 after deducting underwriting discounts and commissions and offering expenses of approximately $2,764. Offering costs were netted against the offering proceeds and recorded to additional paid-in capital. The June 2021 Public Offering was made pursuant to the Company’s effective shelf registration statement on Form S-3 (No. 333-236583), filed with the Securities and Exchange Commission (“SEC”) and declared effective by the SEC on April 10, 2020, including a prospectus contained therein dated as of April 10, 2020, as supplemented by a prospectus supplement, dated June 17, 2021. March 2020 Public Offering On February 27, 2020, the Company entered into an underwriting agreement with H.C. Wainwright, as underwriter, relating to the offering, issuance and sale of 1,400,000 shares of common stock, pre-funded warrants to purchase 433,333 shares of common stock (the “CMPO Pre-Funded Warrants”), and accompanying common warrants to purchase up to an aggregate of 1,833,333 shares of common stock (the “firm warrants”). The Company also granted H.C. Wainwright, as underwriter, a 30-day option to purchase up to 275,000 additional shares of common stock and/or common warrants to purchase up to an aggregate of 275,000 shares of common stock, which H.C. Wainwright partially exercised on March 2, 2020 to purchase 149,860 shares of common stock and common warrants to purchase 275,000 shares of common stock (the “option warrants,” and together with the firm warrants, the “CMPO Common Warrants”). The combined price to the public in this offering for each share of common stock and accompanying common warrants was $3.00, and the combined price to the public in this offering for each pre-funded warrant and accompanying common warrant was $2.999. The March 2020 Public Offering closed on March 3, 2020. At closing, the Company also issued to designees of H.C. Wainwright, as underwriter, warrants to purchase an aggregate of up to 59,496 shares of common stock (the “CMPO UW Warrants”) representing 3.0% of the aggregate number of shares of common stock sold and shares of common stock underlying the pre-funded warrants sold in the March 2020 Public Offering. Net proceeds from the offering were approximately $5,158 after deducting underwriting discounts and commissions and offering expenses of approximately $791. Offering costs were netted against the offering proceeds and recorded to additional paid-in capital. During the first quarter of 2020, all of the CMPO Pre-Funded Warrants were exercised in full, such that there were no more of the CMPO Pre-Funded Warrants outstanding as of March 31, 2020. The CMPO Pre-Funded Warrants had an exercise price of $0.001 per share. The CMPO Common Warrants have an exercise price of $3.00 per share and expire five years from the date of issuance. The CMPO UW Warrants have an exercise price of $3.75 per share and expire five years from the date of issuance. For the years ended December 31, 2021 and 2020, respectively, warrant holders exercised (i) a total of 10,000 and 1,845,917 CMPO Common Warrants, and (ii) 48,192 and none of the CMPO UW Warrants. As of December 31, 2021, there were 252,417 CMPO Common Warrants and 11,304 CMPO UW Warrants outstanding. Common warrants and underwriter warrants. The CMPO Common Warrants and CMPO UW Warrants include certain provisions that establish warrant holder settlement rights that take effect upon the occurrence of certain fundamental transactions. The CMPO Common Warrants and the CMPO UW Warrants define a fundamental transaction to generally include any consolidation, merger or other transaction whereby another entity acquires more than 50% of the Company’s outstanding common stock or the sale of all or substantially all of the Company’s assets. The fundamental transaction provision provides the warrant holders with the option to settle any unexercised warrants for cash in the event of certain fundamental transactions that are within the control of the Company. For any fundamental transaction that is not within the control of the Company, including a fundamental transaction not approved by the Company’s board of directors, the warrant holder will only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the stockholders of the Company in connection with the fundamental transaction, whether that consideration be in the form of cash, stock or any combination thereof. In the event of any fundamental transaction, and regardless of whether it is within the control of the Company, the settlement amount of the CMPO Common Warrants and the CMPO UW Warrants (whether in cash, stock or a combination thereof) is determined based upon a Black-Scholes value that is calculated using inputs as specified in the CMPO Common Warrants and the CMPO UW Warrants, including a defined volatility input equal to the greater of the Company’s 100-day historical volatility or 100%. The CMPO Common Warrants and CMPO UW Warrants also include a separate provision whereby the exercisability of such warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than 4.99% (or an amount up to 9.99% if the holder so elects) of the Company’s common stock. The Company assessed the CMPO Common Warrants and the CMPO UW Warrants for appropriate equity or liability classification pursuant to the Company’s accounting policy described in Note 1—Organization and Significant Accounting Policies. During this assessment, the Company determined (i) the CMPO Common Warrants and the CMPO UW Warrants did not constitute a liability under ASC 480; (ii) the CMPO Common Warrants and the CMPO UW Warrants met the definition of a derivative under ASC 815; (iii) the warrant holder’s option to receive a net cash settlement payment under the CMPO Common Warrants and the CMPO UW Warrants only becomes exercisable upon the occurrence of certain specified fundamental transactions that are within the control of the Company; (iv) upon the occurrence of a fundamental transaction that is not within the control of the Company, the warrant holder would receive the same type or form of consideration offered and paid to common stockholders; (v) the CMPO Common Warrants and the CMPO UW Warrants are indexed to the Company’s common stock; and (vi) the CMPO Common Warrants and the CMPO UW Warrants met all other conditions for equity classification under ASC 480 and ASC 815. Based on the results of this assessment, the Company concluded that the CMPO Common Warrants and the CMPO UW Warrants are freestanding equity-linked derivative instruments that met the criteria for the own-equity scope exception to derivative accounting under ASC 815. Accordingly, the CMPO Common Warrants and the CMPO UW Warrants were classified as equity and were accounted for as a component of additional paid-in capital at the time of issuance. Pre-funded warrants . The CMPO Pre-Funded Warrants’ fundamental transaction provision did not provide the warrant holders with the option to settle any unexercised warrants for cash in the event of any fundamental transactions; rather, in all fundamental transaction scenarios, the warrant holder was only entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion) that was being offered and paid to the stockholders of the Company in connection with the fundamental transaction, whether that consideration be in the form of cash, stock or any combination thereof. The CMPO Pre-Funded Warrants also included a separate provision whereby the exercisability of the warrants could be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than 4.99% (or an amount up to 9.99% if the holder so elects) of the Company’s common stock. The Company assessed the CMPO Pre-Funded Warrants for appropriate equity or liability classification pursuant to the Company’s accounting policy described in Note 1—Organization and Significant Accounting Policies. During this assessment, the Company determined the CMPO Pre-Funded Warrants were freestanding instruments that did not meet the definition of a liability pursuant to ASC 480 and did not meet the definition of a derivative pursuant to ASC 815. The CMPO Pre-Funded Warrants were indexed to the Company’s common stock and met all other conditions for equity classification under ASC 480 and ASC 815. Based on the results of this assessment, the Company concluded that the CMPO Pre-Funded Warrants were freestanding equity-linked financial instruments that met the criteria for equity classification under ASC 480 and ASC 815. Accordingly, the CMPO Pre-Funded Warrants were classified as equity and were accounted for as a component of additional paid-in capital at the time of issuance. March 2020 Registered Direct Offering On March 24, 2020, the Company entered into a securities purchase agreement with several institutional and accredited investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering priced at the market, an aggregate of 1,055,000 shares of the Company’s common stock and pre-funded warrants to purchase 805,465 shares of common stock (the “RDO Pre-Funded Warrants”). The purchase price for each share of common stock was $4.30, and the price for each pre-funded warrant was $4.299. The March 2020 Registered Direct Offering closed on March 26, 2020. At closing, the Company also issued to designees of H.C. Wainwright, as placement agent, warrants to purchase an aggregate of up to 55,814 shares of common stock (the “RDO PA Warrants”) representing 3.0% of the aggregate number of shares of common stock sold and shares of common stock underlying the pre-funded warrants sold in the March 2020 Registered Direct Offering. Net proceeds from the offering were approximately $7,225 after deducting fees and commissions and offering expenses of approximately $774. Offering costs were netted against the offering proceeds and recorded to additional paid-in capital. During the first six months of 2020, all of the RDO Pre-Funded Warrants were exercised in full, such that there were no more of the RDO Pre-Funded Warrants outstanding as of June 30, 2020. The RDO Pre-Funded Warrants had an exercise price of $0.001 per share. The RDO PA Warrants have an exercise price of $5.375 per share and expire five years from the date of issuance. For the years ended December 31, 2021 and 2020, respectively, warrant holders exercised a total of 45,209 and none of the RDO PA Warrants. As of December 31, 2021, there were 10,605 RDO PA Warrants outstanding. Placement agent warrants. The RDO PA Warrants contain substantially similar terms as the CMPO UW Warrants, including fundamental transaction settlement provisions. The Company conducted an assessment of the RDO PA Warrants for appropriate equity or liability classification pursuant to the Company’s accounting policy described in Note 1—Organization and Significant Accounting Policies. The Company reached the same determinations as described above for the CMPO UW Warrants, and the Company concluded that the RDO PA Warrants are freestanding equity-linked derivative instruments that met the criteria for the own-equity scope exception to derivative accounting under ASC 815. Accordingly, the RDO PA Warrants were classified as equity and were accounted for as a component of additional paid-in capital at the time of issuance. Pre-funded warrants . The RDO Pre-Funded Warrants contained substantially similar terms as the CMPO Pre-Funded Warrants, including fundamental transaction settlement provisions that did not provide the warrant holders with the option to settle any unexercised warrants for cash in the event of any fundamental transactions; rather, in all fundamental transaction scenarios, the warrant holder was only entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the stockholders of the Company in connection with the fundamental transaction, whether that consideration be in the form of cash, stock or any combination thereof. The Company conducted an assessment of the RDO Pre-Funded Warrants for appropriate equity or liability classification pursuant to the Company’s accounting policy described in Note 1—Organization and Significant Accounting Policies. The Company reached the same determinations as described above for the CMPO Pre-Funded Warrants, and the Company concluded that the RDO Pre-Funded Warrants were freestanding equity-linked financial instruments that met the criteria for equity classification under ASC 480 and ASC 815. Accordingly, the RDO Pre-Funded Warrants were classified as equity and were accounted for as a component of additional paid-in capital at the time of issuance. January 2018 Offering On January 9, 2018, the Company completed a public offering of its common stock and warrants pursuant to the Company’s then-effective shelf registration statement (the “January 2018 Offering”), pursuant to which it sold an aggregate of 1,000,000 shares of common stock and warrants to purchase up to 1,000,000 shares of the Company’s common stock at a public offering price of $38.00 per share of common stock and accompanying warrant. The warrant exercise price is $46.60 per share and will expire four years from the date of issuance. Net proceeds from the offering were approximately $35,194 after deducting underwriting discounts and commissions and offering expenses of approximately $2,806. The warrants issued in the January 2018 Offering include certain provisions that establish certain warrant holder settlement rights that take effect upon the occurrence of certain fundamental transactions. The warrants define a fundamental transaction to generally include any consolidation or merger whereby another entity acquires more than 50% of the Company’s outstanding common stock or the sale of all or substantially all of the Company’s assets. The fundamental transaction provision provides the warrant holders with the option to settle any unexercised warrants for cash in the event of certain fundamental transactions that are within the control of the Company. For any fundamental transaction that is not within the control of the Company, including a fundamental transaction not approved by the Company’s board of directors, the warrant holder will only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the stockholders of the Company in connection with the fundamental transaction, whether that consideration be in the form of cash, stock or any combination thereof. In the event of any fundamental transaction, and regardless of whether it is within the control of the Company, the settlement amount of the warrants (whether in cash, stock or a combination thereof) is determined based upon a Black-Scholes value that is calculated using inputs as specified in the warrants, including a defined volatility input equal to the greater of the Company’s 100-day historical volatility or 100%. The warrants also include a provision whereby the exercisability of the warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than 4.99% (or an amount up to 9.99% if the holder so elects) of the Company’s common stock. The warrants also provide that this exercise limitation provision is not applicable to any warrant holder that beneficially owns 10.0% or more of the Company’s outstanding common stock immediately following the closing of the January 2018 Offering and the issuance of the accompanying warrants. There were exercises of 150 warrants issued in the January 2018 Offering during the year ended December 31, 2021. There were no exercises of warrants issued in the January 2018 Offering during the year ended December 31, 2020. The Company assessed the warrants for appropriate equity or liability classification pursuant to the Company’s accounting policy described in Note 1—Organization and Significant Accounting Policies. During this assessment, the Company determined that (i) the warrants did not constitute a liability under ASC 480; (ii) the warrants met the definition of a derivative under ASC 815; (iii) the warrant holder’s option to receive a net cash settlement payment only becomes exercisable upon the occurrence of certain specified fundamental transactions that are within the control of the Company; (iv) upon the occurrence of a fundamental transaction that is not within the control of the Company, the warrant holder would receive the same type or form of consideration offered and paid to common stockholders; (v) the warrants are indexed to the Company’s common stock; and (vi) the warrants met all other conditions for equity classification under ASC 480 and ASC 815. Based on the results of this assessment, the Company concluded that the warrants issued in January 2018 are freestanding equity-linked derivative instruments that met the criteria for the own-equity scope exception to derivative accounting under ASC 815. Accordingly, the warrants were classified as equity and were accounted for as a component of additional paid-in capital at the time of issuance. The following table presents the Company’s outstanding warrants to purchase common stock for the periods indicated. December 31, Exercise 2021 2020 Warrants to purchase common stock issued in the January 2018 Offering 999,850 1,000,000 $ 46.60 Warrants to purchase common stock issued in the March 2020 Public Offering 252,417 262,417 3.00 Underwriter warrants to purchase common stock associated with the March 2020 Public Offering 11,304 59,496 3.75 Placement agent warrants to purchase common stock issued in the March 2020 Registered Direct Offering 10,605 55,814 5.375 1,274,176 1,377,727 The weighted average exercise price per share for warrants outstanding as of December 31, 2021 and 2020 was $37.24 and $34.77, respectively. For the years ended December 31, 2021 and 2020, total proceeds from the exercise of warrants was $461 and $5,538, respectively. Aspire Common Stock Purchase Agreements July 2020 Aspire Common Stock Purchase Agreement On July 21, 2020, the Company entered into the July 2020 Aspire CSPA, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30,000 of shares of the Company’s common stock at the Company’s request from time to time during the 30-month term of the July 2020 Aspire CSPA. Upon execution of the July 2020 Aspire CSPA, the Company agreed to sell to Aspire Capital 555,555 shares of its common stock at $9.00 per share for proceeds of $5,000. In consideration for entering into the July 2020 Aspire CSPA, upon satisfaction of certain conditions under the July 2020 Aspire CSPA, the Company issued to Aspire Capital 100,000 shares of the Company’s common stock (the “July 2020 Commitment Shares”). The July 2020 Commitment Shares, valued at approximately $847, were recorded in July 2020 as non-cash costs of equity financing and included within general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. The July 2020 Aspire CSPA replaced the June 2020 Aspire CSPA, which was terminated under the terms of the July 2020 Aspire CSPA. See below for the terms of the June 2020 Aspire CSPA. Concurrently with entering into the July 2020 Aspire CSPA, the Company also entered into a registration rights agreement with Aspire Capital, in which the Company agreed to file with the Securities and Exchange Commission (the “SEC”) one or more registration statements, as necessary, and to the extent permissible and subject to certain exceptions, to register under the Securities Act of 1933, as amended (the “Securities Act”), the sale of the shares of the Company’s common stock that may be issued to Aspire Capital under the July 2020 Aspire CSPA. On July 23, 2020, the Company filed with the SEC a prospectus supplement to the Company’s effective shelf Registration Statement on Form S-3 (File No. 333-236583) registering all of the shares of common stock that may be offered to Aspire Capital from time to time. Under the terms of the July 2020 Aspire CSPA, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a “July 2020 Purchase Notice”), directing Aspire Capital (as principal) to purchase up to 30,000 shares of the Company’s common stock per business day, up to an aggregate of $30,000 (including the initial purchase shares) of the Company’s common stock in the aggregate at a per share price (the “July 2020 Purchase Price”) equal to the lesser of (i) the lowest sale price of the Company’s common stock on the purchase date; or (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date. The aggregate purchase price payable by Aspire Capital on any one purchase date may not exceed $500, unless otherwise mutually agreed. The parties may mutually agree to increase the number of shares of the Company’s common stock that may be purchased per trading day pursuant to the terms of the July 2020 Aspire CSPA to up to 200,000 shares. In addition, on any date on which the Company submits a July 2020 Purchase Notice to Aspire Capital in an amount equal to 30,000 shares, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a “July 2020 VWAP Purchase Notice”) directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s common stock traded on its principal market on the next trading day (the “July 2020 VWAP Purchase Date”), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such July 2020 VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Company’s common stock traded on its principal market on the July 2020 VWAP Purchase Date. The July 2020 Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the period(s) used to compute the July 2020 Purchase Price. The Company may deliver multiple July 2020 Purchase Notices and July 2020 VWAP Purchase Notices to Aspire Capital from time to time during the term of the July 2020 Aspire CSPA, so long as the most recent purchase has been completed. The July 2020 Aspire CSPA provides that the Company and Aspire Capital shall not effect any sales under the July 2020 Aspire CSPA on any purchase date where the closing sale price of the Company’s common stock is less than $0.15. There are no trading volume requirements or restrictions under the July 2020 Aspire CSPA, and the Company will control the timing and amount of sales of the Company’s common stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases from the Company as directed by the Company in accordance with the July 2020 Aspire CSPA. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financing transactions, rights of first refusal, participation rights, penalties or liquidated damages in the July 2020 Aspire CSPA. The July 2020 Aspire CSPA may be terminated by the Company at any time, at its discretion, without any penalty or additional cost to the Company. Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of the Company’s common stock during any time prior to the termination of the July 2020 Aspire CSPA. Any proceeds the Company receives under the July 2020 Aspire CSPA are expected to be used for working capital and general corporate purposes. The July 2020 Aspire CSPA provides that the number of shares that may be sold pursuant to the July 2020 Aspire CSPA will be limited to 2,543,364 shares (the “July 2020 Exchange Cap”), which represents 19.99% of the Company’s outstanding shares of common stock on July 21, 2020, unless stockholder approval or an exception pursuant to the rules of the Company’s principal market, currently the Nasdaq Capital Market, is obtained to issue more than 19.99%. This limitation will not apply if, at any time the July 2020 Exchange Cap is reached and at all times thereafter, the average price paid for all shares issued under the July 2020 Aspire CSPA is equal to or greater than $5.907, which is the arithmetic average of the five closing sale prices of the Company’s common stock immediately preceding the execution of the July 2020 Aspire CSPA. The Company is not required or permitted to issue any shares of common stock under the July 2020 Aspire CSPA if such issuance would breach its obligations under the rules or regulations of the Nasdaq Capital Market. The Company may, in its sole discretion, determine whether to obtain stockholder approval to issue more than 19.99% of its outstanding shares of Common Stock hereunder if such issuance would require stockholder approval under the rules or regulations of the Nasdaq Capital Market. As of December 31, 2021, from the inception of the July 2020 Aspire CSPA, the Company has sold 2,221,040 shares of its common stock at an average price of $8.10 per share, including 555,555 shares of its common stock at $9.00 which the Company agreed to sell to Aspire Capital upon execution of the July 2020 Aspire CSPA, for total proceeds of $17,995. As of December 31, 2021, the Company had $12,005 in remaining availability for sales of its common stock under the July 2020 Aspire CSPA. June 2020 Aspire Common Stock Purchase Agreement On June 15, 2020, the Company entered into the June 2020 Aspire CSPA, which provided that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $20,000 of shares of the Company’s common stock at the Company’s request from time to time during the 30-month term of the Purchase Agreement. The June 2020 Aspire CSPA replaced the 2019 Aspire CSPA, which was terminated under the terms of the June 2020 Aspire CSPA. See below for terms of the 2019 Aspire CSPA. Concurrently with entering into the June 2020 Aspire CSPA, the Company also entered into a registration rights agreement with Aspire Capital, in which the Company agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act, registering the sale of the shares of the Company’s common stock that have been issued to Aspire Capital under the June 2020 Aspire CSPA. On June 17, 2020, the Company filed with the SEC, a prospectus supplement to the Company’s effective shelf Registration Statement on Form S-3 (File No. 333-236583) registering all of the shares of common stock that were issued to Aspire Capital under the June 2020 Aspire CSPA. Under the terms of the June 2020 Aspire CSPA, on any trading day selected by the Company, the Company had the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a “June 2020 Purchase Notice”), directing Aspire Capital (as principal) to purchase up to 30,000 shares of the Company’s common stock per business day, up to an aggregate of $20,000 of the Company’s common stock, at a per share price (the “June 2020 Purchase Price”) equal to the lesser of (i) the lowest sale price of the Company’s common stock on the purchase date; or (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date. The aggregate purchase price payable by Aspire Capital on any one purchase date could not exceed $500, unless otherwise mutually agreed. The parties could mutually agree to increase the number of shares of the Company’s common stock that may be purchased per trading day pursuant to the terms of the June 2020 Aspire CSPA to up to 200,000 shares. In addition, on any date on which the Company submitted a June 2020 Purchase Notice to Aspire Capital in an amount equal to 30,000 shares, the Company also had the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a “June 2020 VWAP Purchase Notice”) directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s common stock traded on its principal market on the next trading day (the “June 2020 VWAP Purchase Date”), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such June 2020 VWAP Purchase Notice was generally 97% of the volume-weighted average price for the Company’s common stock traded on its principal market on the June 2020 VWAP Purchase Date. The June 2020 Purchase Price would have been adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the period(s) used to compute the June 2020 Purchase Price. The Company could deliver multiple June 2020 Purchase Notices and June 2020 VWAP Purchase Notices to Aspire Capital from time to time during the term of the June 2020 Aspire CSPA, so long as the most recent purchase had been completed. The June 2020 Aspire CSPA provided that the Company and Aspire Capital would not effect any sales under the June 2020 Aspire CSPA on any purchas |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2016 Incentive Award Plan Effective September 20, 2016 (the “Effective Date”), the Company adopted the 2016 Incentive Award Plan (the “2016 Plan”). The 2016 Plan is the successor to the Company’s 2008 Stock Plan (the “2008 Plan”). As of the Effective Date, no additional awards were granted under the 2008 Plan, but all stock awards granted under the 2008 Plan prior to the Effective Date remain subject to the terms of the 2008 Plan. Any shares associated with stock awards previously granted under the 2008 Plan that are forfeited subsequent to the Effective Date of the 2016 Plan are not eligible for future issuance under the 2016 Plan. All awards granted on and after the Effective Date will be subject to the terms of the 2016 Plan. The 2016 Plan provides for the grant of the following awards: (i) incentive stock options, (ii) nonstatutory stock options, (iii) SARs, (iv) restricted stock awards, (v) restricted stock unit awards and (vi) other stock awards. Eligible plan participants include employees, directors, and consultants. An aggregate of 83,333 shares of the Company’s common stock were initially available for issuance under awards granted pursuant to the 2016 Plan, which shares may be authorized but unissued shares, treasury shares, or shares purchased in the open market. On June 5, 2017, the Company’s stockholders approved an amendment to the 2016 Plan to increase the aggregate number of shares of common stock that may be issued pursuant to awards under the 2016 Plan by an additional 120,000 shares. All other material terms of the 2016 Plan otherwise remained unchanged. On July 31, 2019, the Company’s stockholders approved an amendment to the 2016 Plan, to increase the number of shares reserved under the 2016 Plan by 100,000 and to increase the award limit on the maximum aggregate number of shares of the Company’s common stock that may be granted to any one person during any calendar year from 25,000 to 100,000 shares of the Company’s common stock. All other material terms of the 2016 Plan otherwise remain unchanged. At the Company’s Annual Meeting of Stockholders held on May 4, 2021, the Company’s stockholders approved an amendment to the 2016 Plan (“the 2016 Plan Amendment”), to increase the aggregate number of shares of the Company’s common stock authorized for issuance thereunder by 1,500,000 shares. This amendment was approved by the Company’s board of directors on March 10, 2021. The approval by the Company’s stockholders of the 2016 Plan Amendment was contingent upon the occurrence of certain other events, including that the 2016 Plan Amendment would become effective at the effective time of a certificate of amendment to the Company’s certificate of incorporation filed with the Secretary of State of the State of Delaware in relation to a potential reverse stock split pursuant to the authority previously granted to the Company’s board of directors by the Company’s stockholders at the 2020 Annual Meeting. The Certificate of Amendment filed in connection with the Reverse Stock Split became effective at 5:00pm on May 25, 2021, and thus, the 2016 Plan Amendment became effective on May 25, 2021. As of December 31, 2021, there were 1,213,224 shares available for future issuance under the 2016 Plan. Under both the 2008 Plan and the 2016 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair value of a common stock share on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the board of directors or compensation committee of the board. The Company’s stock options vest based on terms in the stock option agreements and have a maximum term of ten years. Stock Appreciation Rights Effective December 17, 2019, the Company entered into an amended and restated employment agreement with Paula Brown Stafford (the “Amended and Restated Stafford Employment Agreement”). On January 6, 2020, following the release of top-line results of the Company’s Phase 3 molluscum clinical program as provided in the Amended and Restated Stafford Employment Agreement, 60,000 stock appreciation rights (“SARs”) were granted to Mrs. Stafford with an exercise price of $8.20 per share (the fair market value of the Company’s common stock on the grant date) and with a ten-year term (the “Stafford SAR Award”). The Stafford SAR Award was granted on a contingent basis and would have been considered irrevocably forfeited and voided in full if sufficient shares of the Company’s common stock were not available under the 2016 Plan or if the Company failed to obtain stockholder approval for amendments to the 2016 Plan at the next annual stockholders’ meeting to provide sufficient shares for the Stafford SAR Award. Such shares became available under the 2016 Plan on February 1, 2020, and the SARs were no longer considered granted on a contingent basis and are classified as equity-based awards. The Stafford SAR Award vested quarterly and was vested in full as of December 31, 2021. During the years ended December 31, 2021 and 2020, the Company recorded employee stock-based compensation expense related to SARs of $115 and $151, respectively. As of December 31, 2021, there were a total of 60,000 SARs outstanding, which were fully exercisable. Inducement Grants In prior years, the Company awarded nonstatutory stock options to purchase shares of common stock to newly-hired employees as inducements material to the individuals’ entering into employment with the Company within the meaning of Nasdaq Listing Rule 5635(c)(4) (the “Inducement Grants”). On May 31, 2018, the Company awarded 10,050 Inducement Grants with an exercise price of $31.50 per share, and on September 6, 2019, the Company awarded 2,500 Inducement Grants with an exercise price of $26.20 per share. The Inducement Grants were awarded outside of the Company’s 2016 Plan, pursuant to Nasdaq Listing Rule 5635(c)(4), but have terms and conditions generally consistent with the Company’s 2016 Plan and vest over three years, subject to the employee’s continued service as an employee or consultant through the vesting period. During the year ended December 31, 2020, the 2,500 Inducement Grants related to the September 6, 2019 award were forfeited in their entirety, and 1,300 Inducement Grants related to the May 31, 2018 award were forfeited. During the year ended December 31, 2021, an additional 7,500 Inducement Grants related to the May 31, 2018 award were forfeited. As of December 31, 2021, there were a total of 1,250 Inducement Grants outstanding. Stock Compensation Expense During the years ended December 31, 2021 and 2020, the Company recorded employee stock-based compensation expense, including fair value adjustments of the Tangible Stockholder Return Plan, as follows: Year Ended December 31, 2021 2020 Stock options $ 826 $ 840 Stock appreciation rights 115 151 Tangible Stockholder Return Plan (Note 12) (666) 317 Total $ 275 $ 1,308 Total stock-based compensation expense for the years ended December 31, 2021 and 2020 included in the accompanying consolidated statements of operations and comprehensive loss is as follows: Year Ended December 31, 2021 2020 Research and development $ (250) $ 834 General and administrative 525 474 Total $ 275 $ 1,308 The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, and the following weighted average assumptions: Year Ended December 31, 2021 2020 Estimated dividend yield — % — % Expected volatility 107.54 % 105.64 % Risk-free interest rate 1.02 % 1.10 % Expected life of options (in years) 5.79 5.46 Weighted-average fair value per share $ 7.13 $ 4.11 The Company estimates forfeitures based on various classes of option grantees and the rates used ranged from 11.9% to 12.2% during the years ended December 31, 2021 and 2020, respectively. Stock option activity for the periods indicated is as follows: Shares Shares Weighted- Weighted- Aggregate Options outstanding as of December 31, 2019 38,844 178,933 $ 38.90 SARs granted (61,000) — SARs forfeited 100,000 — Options granted (55,700) 55,700 5.21 Options forfeited 30,234 (34,284) 32.89 Options exercised — (1,150) 4.65 Options outstanding as of December 31, 2020 52,378 199,199 $ 30.71 Additional shares reserved under plan 1,500,000 — SARs granted — — SARs forfeited 1,000 — Options granted (385,885) 385,885 8.82 Options forfeited 45,731 (53,689) 26.72 Options exercised — (12,842) 4.74 Options outstanding as of December 31, 2021 1,213,224 518,553 $ 15.48 8.76 $ 2 Vested and expected to vest as of 198,377 $ 30.75 7.64 $ 147 Exercisable as of December 31, 2020 178,287 $ 32.56 7.53 $ 141 Vested and expected to vest as of 470,773 $ 16.24 8.67 $ 2 Exercisable as of December 31, 2021 200,638 $ 26.59 7.46 $ 2 Performance Plan On August 2, 2018, the Company’s board of directors approved and established the Tangible Stockholder Return Plan, which is a performance-based long-term incentive plan (the “Performance Plan”). The Performance Plan was effective immediately upon approval and expires on March 1, 2022. The Performance Plan covers all employees, including the Company’s executive officers, consultants and other persons deemed eligible by the Company’s compensation committee. The core underlying metric of the Performance Plan is the achievement of two share price goals for the Company’s common stock, which if achieved, would represent measurable increases in stockholder value. The Performance Plan was adjusted on May 25, 2021 as a result of the 1-for-10 Reverse Stock Split, which correspondingly adjusted the two share price goals. The Performance Plan is tiered, with two separate tranches, each of which has a distinct share price target (measured as the average publicly traded share price of the Company’s common stock on the Nasdaq stock exchange for a 30 consecutive trading day period) that will, if achieved, trigger a distinct fixed bonus pool. As adjusted for the Reverse Stock Split, the share price target for the first tranche and related bonus pool are $111.70 per share and $25,000, respectively. As adjusted for the Reverse Stock Split, the share price target for the second tranche and related bonus pool are $254.50 per share and $50,000, respectively. The compensation committee has discretion to distribute the bonus pool related to each tranche among eligible participants by establishing individual minimum bonus amounts before, as well as by distributing the remainder of the applicable pool after, the achievement of each tranche specific share price target. Otherwise, if the Company does not achieve one or both related share price targets, as defined, no portion of the bonus pools will be paid. The Performance Plan provides for the distinct fixed bonus pools to be paid in the form of cash. However, the compensation committee has discretion to pay any bonus due under the Performance Plan in the form of cash, shares of the Company’s common stock or a combination thereof, provided that the Company’s stockholders have approved the reservation of shares of the Company’s common stock for such payment. The Performance Plan permits the compensation committee to make bonus awards subject to varying payment terms, including awards that vest and are payable immediately upon achieving an applicable share price target as well as awards that pay over an extended period (either with or without ongoing employment requirements). The Performance Plan contemplates that no bonus award payments will be delayed beyond 24 months for named executive officers or more than 12 months for all other participants. For purposes of determining whether a share price target has been met, the share price targets will be adjusted in the event of any stock splits, cash dividends, stock dividends, combinations, reorganizations, reclassifications or similar events. In the event of a change in control, as defined in the Performance Plan, during the term of the Performance Plan, a performance bonus pool will become due and payable to participants on a pro-rata basis, as calculated and determined by the compensation committee based on the Company’s progress toward the share price target as of the date of the change in control and subject to adjustment by the compensation committee as permitted under the Performance Plan. The Company has concluded that the Performance Plan is within the scope of ASC 718 , Compensation — Stock Compensation as the underlying plan obligations are based on the potential attainment of certain market share price targets of the Company’s common stock. Any awards under the Performance Plan would be payable, at the discretion of the Company’s compensation committee following the achievement of the applicable share price target, in cash, shares of the Company’s common stock, or a combination thereof, provided that, prior to any payment in common stock, the Company’s stockholders have approved the reservation of shares of the Company’s common stock for such payment. ASC 718 requires that a liability-based award should be classified as a liability on the Company’s accompanying consolidated balance sheets and the amount of compensation cost recognized should be based on the fair value of the liability. When a liability-based award includes both a service and market condition, the market condition is taken into account when determining the appropriate method to estimate fair value and the compensation cost is amortized over the estimated service period. Therefore, the liability associated with the Performance Plan obligation is recorded within other long-term liabilities on the accompanying consolidated balance sheets at the estimated fair value on the date of issuance and is re-valued each subsequent reporting period end. The Company recognizes stock-based compensation expense within operating expenses in the accompanying consolidated statements of operations and comprehensive loss, including adjustments to the fair value of the liability-based award, on a straight-line basis over the requisite service period. The fair value of obligations under the Performance Plan are estimated using a Monte Carlo simulation approach. The Company’s common stock price is simulated under the Geometric Brownian Motion framework under each simulation path. The other assumptions for the Monte Carlo simulation include the risk-free interest rate, estimated volatility and the expected term. Expected stock price volatility is based on the Company’s actual historical volatility over a historical period equal to the expected remaining life of the plan, adjusted for certain market considerations and other factors. The fair value of the underlying common stock is the published closing market price on the Company’s principal market, which is currently the Nasdaq Capital Market, as of each reporting date, as adjusted for significant results, as necessary (if applicable). The risk-free interest rate is based on the United States Treasury yield curve in effect on the date of valuation equal to the remaining expected life of the plan. The dividend yield percentage is zero because the Company does not currently pay dividends, nor does it intend to do so during the expected term of the plan. The expected life of bonus awards under the Performance Plan is assumed to be equivalent to the remaining contractual term based on the estimated service period including the service inception date of the plan participants and the contractual end of the Performance Plan. The fair value of the Performance Plan is estimated at each financial reporting date using the Monte Carlo simulation model and the following assumptions: December 31, 2021 2020 Estimated dividend yield — — Expected volatility 125.72 % 200.00 % Risk-free interest rate 0.07 % 0.11 % Expected term (years) 0.17 1.17 Fair value per share of common stock underlying the Performance Plan $ 4.26 $ 8.70 |
Tangible Stockholder Return Pla
Tangible Stockholder Return Plan | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Tangible Shareholder Return Plan | Stock-Based Compensation 2016 Incentive Award Plan Effective September 20, 2016 (the “Effective Date”), the Company adopted the 2016 Incentive Award Plan (the “2016 Plan”). The 2016 Plan is the successor to the Company’s 2008 Stock Plan (the “2008 Plan”). As of the Effective Date, no additional awards were granted under the 2008 Plan, but all stock awards granted under the 2008 Plan prior to the Effective Date remain subject to the terms of the 2008 Plan. Any shares associated with stock awards previously granted under the 2008 Plan that are forfeited subsequent to the Effective Date of the 2016 Plan are not eligible for future issuance under the 2016 Plan. All awards granted on and after the Effective Date will be subject to the terms of the 2016 Plan. The 2016 Plan provides for the grant of the following awards: (i) incentive stock options, (ii) nonstatutory stock options, (iii) SARs, (iv) restricted stock awards, (v) restricted stock unit awards and (vi) other stock awards. Eligible plan participants include employees, directors, and consultants. An aggregate of 83,333 shares of the Company’s common stock were initially available for issuance under awards granted pursuant to the 2016 Plan, which shares may be authorized but unissued shares, treasury shares, or shares purchased in the open market. On June 5, 2017, the Company’s stockholders approved an amendment to the 2016 Plan to increase the aggregate number of shares of common stock that may be issued pursuant to awards under the 2016 Plan by an additional 120,000 shares. All other material terms of the 2016 Plan otherwise remained unchanged. On July 31, 2019, the Company’s stockholders approved an amendment to the 2016 Plan, to increase the number of shares reserved under the 2016 Plan by 100,000 and to increase the award limit on the maximum aggregate number of shares of the Company’s common stock that may be granted to any one person during any calendar year from 25,000 to 100,000 shares of the Company’s common stock. All other material terms of the 2016 Plan otherwise remain unchanged. At the Company’s Annual Meeting of Stockholders held on May 4, 2021, the Company’s stockholders approved an amendment to the 2016 Plan (“the 2016 Plan Amendment”), to increase the aggregate number of shares of the Company’s common stock authorized for issuance thereunder by 1,500,000 shares. This amendment was approved by the Company’s board of directors on March 10, 2021. The approval by the Company’s stockholders of the 2016 Plan Amendment was contingent upon the occurrence of certain other events, including that the 2016 Plan Amendment would become effective at the effective time of a certificate of amendment to the Company’s certificate of incorporation filed with the Secretary of State of the State of Delaware in relation to a potential reverse stock split pursuant to the authority previously granted to the Company’s board of directors by the Company’s stockholders at the 2020 Annual Meeting. The Certificate of Amendment filed in connection with the Reverse Stock Split became effective at 5:00pm on May 25, 2021, and thus, the 2016 Plan Amendment became effective on May 25, 2021. As of December 31, 2021, there were 1,213,224 shares available for future issuance under the 2016 Plan. Under both the 2008 Plan and the 2016 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair value of a common stock share on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the board of directors or compensation committee of the board. The Company’s stock options vest based on terms in the stock option agreements and have a maximum term of ten years. Stock Appreciation Rights Effective December 17, 2019, the Company entered into an amended and restated employment agreement with Paula Brown Stafford (the “Amended and Restated Stafford Employment Agreement”). On January 6, 2020, following the release of top-line results of the Company’s Phase 3 molluscum clinical program as provided in the Amended and Restated Stafford Employment Agreement, 60,000 stock appreciation rights (“SARs”) were granted to Mrs. Stafford with an exercise price of $8.20 per share (the fair market value of the Company’s common stock on the grant date) and with a ten-year term (the “Stafford SAR Award”). The Stafford SAR Award was granted on a contingent basis and would have been considered irrevocably forfeited and voided in full if sufficient shares of the Company’s common stock were not available under the 2016 Plan or if the Company failed to obtain stockholder approval for amendments to the 2016 Plan at the next annual stockholders’ meeting to provide sufficient shares for the Stafford SAR Award. Such shares became available under the 2016 Plan on February 1, 2020, and the SARs were no longer considered granted on a contingent basis and are classified as equity-based awards. The Stafford SAR Award vested quarterly and was vested in full as of December 31, 2021. During the years ended December 31, 2021 and 2020, the Company recorded employee stock-based compensation expense related to SARs of $115 and $151, respectively. As of December 31, 2021, there were a total of 60,000 SARs outstanding, which were fully exercisable. Inducement Grants In prior years, the Company awarded nonstatutory stock options to purchase shares of common stock to newly-hired employees as inducements material to the individuals’ entering into employment with the Company within the meaning of Nasdaq Listing Rule 5635(c)(4) (the “Inducement Grants”). On May 31, 2018, the Company awarded 10,050 Inducement Grants with an exercise price of $31.50 per share, and on September 6, 2019, the Company awarded 2,500 Inducement Grants with an exercise price of $26.20 per share. The Inducement Grants were awarded outside of the Company’s 2016 Plan, pursuant to Nasdaq Listing Rule 5635(c)(4), but have terms and conditions generally consistent with the Company’s 2016 Plan and vest over three years, subject to the employee’s continued service as an employee or consultant through the vesting period. During the year ended December 31, 2020, the 2,500 Inducement Grants related to the September 6, 2019 award were forfeited in their entirety, and 1,300 Inducement Grants related to the May 31, 2018 award were forfeited. During the year ended December 31, 2021, an additional 7,500 Inducement Grants related to the May 31, 2018 award were forfeited. As of December 31, 2021, there were a total of 1,250 Inducement Grants outstanding. Stock Compensation Expense During the years ended December 31, 2021 and 2020, the Company recorded employee stock-based compensation expense, including fair value adjustments of the Tangible Stockholder Return Plan, as follows: Year Ended December 31, 2021 2020 Stock options $ 826 $ 840 Stock appreciation rights 115 151 Tangible Stockholder Return Plan (Note 12) (666) 317 Total $ 275 $ 1,308 Total stock-based compensation expense for the years ended December 31, 2021 and 2020 included in the accompanying consolidated statements of operations and comprehensive loss is as follows: Year Ended December 31, 2021 2020 Research and development $ (250) $ 834 General and administrative 525 474 Total $ 275 $ 1,308 The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, and the following weighted average assumptions: Year Ended December 31, 2021 2020 Estimated dividend yield — % — % Expected volatility 107.54 % 105.64 % Risk-free interest rate 1.02 % 1.10 % Expected life of options (in years) 5.79 5.46 Weighted-average fair value per share $ 7.13 $ 4.11 The Company estimates forfeitures based on various classes of option grantees and the rates used ranged from 11.9% to 12.2% during the years ended December 31, 2021 and 2020, respectively. Stock option activity for the periods indicated is as follows: Shares Shares Weighted- Weighted- Aggregate Options outstanding as of December 31, 2019 38,844 178,933 $ 38.90 SARs granted (61,000) — SARs forfeited 100,000 — Options granted (55,700) 55,700 5.21 Options forfeited 30,234 (34,284) 32.89 Options exercised — (1,150) 4.65 Options outstanding as of December 31, 2020 52,378 199,199 $ 30.71 Additional shares reserved under plan 1,500,000 — SARs granted — — SARs forfeited 1,000 — Options granted (385,885) 385,885 8.82 Options forfeited 45,731 (53,689) 26.72 Options exercised — (12,842) 4.74 Options outstanding as of December 31, 2021 1,213,224 518,553 $ 15.48 8.76 $ 2 Vested and expected to vest as of 198,377 $ 30.75 7.64 $ 147 Exercisable as of December 31, 2020 178,287 $ 32.56 7.53 $ 141 Vested and expected to vest as of 470,773 $ 16.24 8.67 $ 2 Exercisable as of December 31, 2021 200,638 $ 26.59 7.46 $ 2 Performance Plan On August 2, 2018, the Company’s board of directors approved and established the Tangible Stockholder Return Plan, which is a performance-based long-term incentive plan (the “Performance Plan”). The Performance Plan was effective immediately upon approval and expires on March 1, 2022. The Performance Plan covers all employees, including the Company’s executive officers, consultants and other persons deemed eligible by the Company’s compensation committee. The core underlying metric of the Performance Plan is the achievement of two share price goals for the Company’s common stock, which if achieved, would represent measurable increases in stockholder value. The Performance Plan was adjusted on May 25, 2021 as a result of the 1-for-10 Reverse Stock Split, which correspondingly adjusted the two share price goals. The Performance Plan is tiered, with two separate tranches, each of which has a distinct share price target (measured as the average publicly traded share price of the Company’s common stock on the Nasdaq stock exchange for a 30 consecutive trading day period) that will, if achieved, trigger a distinct fixed bonus pool. As adjusted for the Reverse Stock Split, the share price target for the first tranche and related bonus pool are $111.70 per share and $25,000, respectively. As adjusted for the Reverse Stock Split, the share price target for the second tranche and related bonus pool are $254.50 per share and $50,000, respectively. The compensation committee has discretion to distribute the bonus pool related to each tranche among eligible participants by establishing individual minimum bonus amounts before, as well as by distributing the remainder of the applicable pool after, the achievement of each tranche specific share price target. Otherwise, if the Company does not achieve one or both related share price targets, as defined, no portion of the bonus pools will be paid. The Performance Plan provides for the distinct fixed bonus pools to be paid in the form of cash. However, the compensation committee has discretion to pay any bonus due under the Performance Plan in the form of cash, shares of the Company’s common stock or a combination thereof, provided that the Company’s stockholders have approved the reservation of shares of the Company’s common stock for such payment. The Performance Plan permits the compensation committee to make bonus awards subject to varying payment terms, including awards that vest and are payable immediately upon achieving an applicable share price target as well as awards that pay over an extended period (either with or without ongoing employment requirements). The Performance Plan contemplates that no bonus award payments will be delayed beyond 24 months for named executive officers or more than 12 months for all other participants. For purposes of determining whether a share price target has been met, the share price targets will be adjusted in the event of any stock splits, cash dividends, stock dividends, combinations, reorganizations, reclassifications or similar events. In the event of a change in control, as defined in the Performance Plan, during the term of the Performance Plan, a performance bonus pool will become due and payable to participants on a pro-rata basis, as calculated and determined by the compensation committee based on the Company’s progress toward the share price target as of the date of the change in control and subject to adjustment by the compensation committee as permitted under the Performance Plan. The Company has concluded that the Performance Plan is within the scope of ASC 718 , Compensation — Stock Compensation as the underlying plan obligations are based on the potential attainment of certain market share price targets of the Company’s common stock. Any awards under the Performance Plan would be payable, at the discretion of the Company’s compensation committee following the achievement of the applicable share price target, in cash, shares of the Company’s common stock, or a combination thereof, provided that, prior to any payment in common stock, the Company’s stockholders have approved the reservation of shares of the Company’s common stock for such payment. ASC 718 requires that a liability-based award should be classified as a liability on the Company’s accompanying consolidated balance sheets and the amount of compensation cost recognized should be based on the fair value of the liability. When a liability-based award includes both a service and market condition, the market condition is taken into account when determining the appropriate method to estimate fair value and the compensation cost is amortized over the estimated service period. Therefore, the liability associated with the Performance Plan obligation is recorded within other long-term liabilities on the accompanying consolidated balance sheets at the estimated fair value on the date of issuance and is re-valued each subsequent reporting period end. The Company recognizes stock-based compensation expense within operating expenses in the accompanying consolidated statements of operations and comprehensive loss, including adjustments to the fair value of the liability-based award, on a straight-line basis over the requisite service period. The fair value of obligations under the Performance Plan are estimated using a Monte Carlo simulation approach. The Company’s common stock price is simulated under the Geometric Brownian Motion framework under each simulation path. The other assumptions for the Monte Carlo simulation include the risk-free interest rate, estimated volatility and the expected term. Expected stock price volatility is based on the Company’s actual historical volatility over a historical period equal to the expected remaining life of the plan, adjusted for certain market considerations and other factors. The fair value of the underlying common stock is the published closing market price on the Company’s principal market, which is currently the Nasdaq Capital Market, as of each reporting date, as adjusted for significant results, as necessary (if applicable). The risk-free interest rate is based on the United States Treasury yield curve in effect on the date of valuation equal to the remaining expected life of the plan. The dividend yield percentage is zero because the Company does not currently pay dividends, nor does it intend to do so during the expected term of the plan. The expected life of bonus awards under the Performance Plan is assumed to be equivalent to the remaining contractual term based on the estimated service period including the service inception date of the plan participants and the contractual end of the Performance Plan. The fair value of the Performance Plan is estimated at each financial reporting date using the Monte Carlo simulation model and the following assumptions: December 31, 2021 2020 Estimated dividend yield — — Expected volatility 125.72 % 200.00 % Risk-free interest rate 0.07 % 0.11 % Expected term (years) 0.17 1.17 Fair value per share of common stock underlying the Performance Plan $ 4.26 $ 8.70 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes There was no income tax benefit recognized for the years ended December 31, 2021 and 2020 due to the Company’s history of net losses combined with an inability to confirm recovery of the tax benefits from the Company’s losses and other net deferred tax assets. The Company has established a valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets. Net operating loss (“NOL”) and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carry forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or “the Code,” as well as similar state tax provisions. The amount of the annual limitation, if any, will be determined based on the value of the company immediately prior to an ownership change. Subsequent ownership changes may further affect the utilization in future years. Additionally, U.S. tax laws limit the time during which certain of these carry forwards may be applied against future taxable income (in the case of NOL carryforwards) and tax liabilities (in the case of tax credits). Therefore, the Company may not be able to take full advantage of these carry forwards for federal or state income tax purposes. During the course of preparing the Company’s consolidated financial statements as of and for the year ended December 31, 2021, the Company completed an assessment of the available NOL and tax credit carryforwards under Sections 382 and 383, respectively, of the Code. The Company determined that it underwent multiple ownership changes throughout its history as defined under Section 382, including most recently in 2015 and 2020. As a result of the identified ownership changes, the portion of NOL and tax credit carryforwards attributable to the pre-ownership change periods are subject to a substantial annual limitation under Sections 382 and 383 of the Code. The Company has adjusted its NOL and tax credit carryforwards to address the impact of the 382 ownership changes. This resulted in a reduction of available federal and state NOLs of $113.8 million and $149.4 million, respectively. The write down of the NOLs reduced the tax loss carryforward line within gross deferred tax assets as previously disclosed by $26.8 million, with a corresponding decrease in the valuation allowance. The Company also reduced its tax credit carryforwards within gross deferred tax assets by $9.7 million with a corresponding decrease in the valuation allowance, comprised of $8.1 million related to Section 383 limitations on prior credits and $1.6 million related to amounts that would not have been recorded during the year ended December 31, 2020 given the 383 limitation. Since the limitation affected the prior period, the Company has adjusted its 2020 tax footnote presentation with respect to the gross NOL deferred tax asset, the tax credit carryforwards and the corresponding valuation allowance. However, there was no net impact to the net deferred tax asset and tax expense as the decreases in the NOL and tax credit carryforwards were offset completely by a corresponding adjustment to the Company’s overall valuation allowance. The reasons for the difference between actual income tax benefit for the years ended December 31, 2021 and 2020, and the amount computed by applying the statutory federal income tax rate to losses before income tax benefit are as follows: Year Ended December 31, 2021 2020 Income tax benefit at federal statutory rate $ (6,235) $ (6,152) State income taxes, net of federal benefit — (533) Non-deductible expenses 63 492 Research and development tax credits (768) (885) Write-off of Attributes Due to Sections 382 and 383 — 34,983 Change in State Tax Rate 1,532 — Other (96) 222 Change in valuation allowance 5,504 (28,127) Total income tax provision $ — $ — Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and deferred tax liabilities are as follows: As of December 31, 2021 2020 Deferred tax assets: Accrued compensation $ 247 $ 214 Accrued liabilities 117 375 Tax loss carryforwards 21,008 16,186 Intangible assets 213 248 Stock-based compensation 499 526 Tax credits 1,653 885 Research and development service obligation 5,575 6,120 Right-of-use lease liabilities 736 — Deferred revenue 1,849 1,649 Fixed assets 305 345 Other 50 52 Total deferred tax assets 32,252 26,600 Less valuation allowance (31,808) (26,304) Net deferred tax asset 444 296 Deferred tax liabilities: Right-of-use lease assets (356) — Other (88) (296) Net noncurrent deferred tax asset (liability) $ — $ — On March 27, 2020, the CARES Act was signed into law and provides for emergency aid to businesses and individuals that are affected by the COVID-19 pandemic. Relief items for businesses included loans administered by the SBA through the PPP, delayed payroll tax payments, an employee retention tax credit, and favorable modifications with respect to the deductibility of interest expense and utilization of net operating losses. As mentioned in Note 9—Paycheck Protection Program, the Company obtained a PPP loan of approximately $956 for which was fully forgiven in 2021. There was no significant impact to the Company as a result of the other provisions within the CARES Act. As of December 31, 2021, the Company had federal and state NOL carryforwards of $100,034 and $62,907, respectively. The NOLs begin to expire in 2028 and 2023 for federal and state tax purposes, respectively. As of December 31, 2021, the Company had government research and development tax credits of approximately $1,653 to offset future federal taxes which begin to expire in 2040. The Company had no unrecognized tax benefits as of December 31, 2021 and 2020. The Company does not anticipate a significant change in total unrecognized tax benefits within the next 12 months. Tax years 2018-2020 remain open to examination by the major taxing jurisdictions to which the Company is subject. Additionally, years prior to 2018 are also open to examination to the extent of loss and credit carryforwards from those years. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Retirement Plan | Retirement PlanThe Company maintains a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers all employees who meet minimum age requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company has made discretionary matching contributions, up to 5% of gross wages during 2021, and up to 3% of gross wages during 2020. The Company contributed $258 and $133, for the years ended December 31, 2021 and 2020, respectively. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Members of the Company’s board of directors held 100,497 and 110,474 shares of the Company’s common stock as of December 31, 2021 and 2020, respectively. Health Decisions On October 25, 2018, the Company announced a foundational collaboration with Health Decisions, Inc. (“Health Decisions”). Health Decisions, which was acquired by Premier Research in July 2021, is a full-service contract research organization specializing in clinical studies of therapeutics for women’s health indications. The Company’s Chairman, President and Chief Executive Officer, Paula Brown Stafford, was a stockholder and previously served on the board of directors of Health Decisions. Reedy Creek Reedy Creek beneficially owned greater than 5% of the Company’s outstanding common stock and held approximately 395,000 warrants, all of which were acquired during the January 2018 Offering, and, accordingly, was a related party of the Company at the time the Company entered into the Purchase Agreement with Reedy Creek, described in Note 6—Research and Development Arrangements. The Purchase Agreement with Reedy Creek was evaluated and approved pursuant to the Company’s existing related party transactions policy. Based solely on information reported in a Schedule 13D/A filed with the SEC on June 24, 2021, Reedy Creek is no longer a greater than 5% stockholder of the Company. 2020 Registered Direct Offering Sabby Volatility Warrant Master Fund, Ltd. (“Sabby”), while a greater than 5% stockholder of the Company, purchased 620,000 shares of common stock and pre-funded warrants to purchase up to 260,233 shares of common stock for approximately $3,800 in the March 2020 Registered Direct Offering described in Note 10—Stockholders’ Equity (Deficit). Sabby’s participation in the March 2020 Registered Direct Offering was evaluated and approved pursuant to the Company’s existing related party transactions policy. Based solely on information reported in a Schedule 13G/A filed with the SEC on January 5, 2021, Sabby no longer held any of the Company’s common stock or pre-funded warrants to purchase shares of the Company’s common stock. Joseph Moglia, while a greater than 5% stockholder of the Company, purchased 100,000 shares of common stock for $430 in the March 2020 Registered Direct Offering described in Note 10—Stockholders’ Equity (Deficit). Mr. Moglia’s participation in the March 2020 Registered Direct Offering was evaluated and approved pursuant to the Company’s existing related party transactions policy. Based solely on information reported in a Schedule 13D/A filed with the SEC on January 27, 2021, Mr. Moglia is no longer a greater than 5% stockholder of the Company. |
Assets Held for Sale, Impairmen
Assets Held for Sale, Impairment Charges | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Assets Held for Sale, Impairment Charges | Assets Held for Sale, Impairment Charges The Company has pursued a broader strategic plan since 2019 to shift its operating cost structure characteristics from fixed to variable, including efforts to reduce or offset its fixed Previous Facility Lease obligation. The Previous Facility once served as the Company’s corporate headquarters and its sole research, development and manufacturing facility. The Company conducted certain activities and engaged in certain transactions during the second and third quarters of 2020 that ultimately achieved relief from the remaining fixed Previous Facility Lease obligation. These activities and transactions had various accounting implications, which are described in detail within this Note and Note 17—Asset Group Disposition. Following the completion of a large scale manufacturing campaign that produced clinical trial materials for the Company’s B-SIMPLE4 Phase 3 study for SB206 in May 2020, and in contemplation of the lease termination transaction described in Note 8—Commitments and Contingencies, the Company initiated decommissioning of the Previous Facility in June 2020, and, on June 29, 2020, the physical removal of the primary components of the large scale manufacturing process equipment from the Previous Facility was deemed substantially complete. As a result of these decommissioning actions, the Company determined that, as of June 29, 2020, the Company had fundamentally changed its intended use of the Previous Facility and certain related assets, including (i) the removal of the Company’s large scale cGMP drug manufacturing capability and (ii) the conditioning of the Previous Facility to facilitate a transaction that would reduce or offset the Company’s remaining fixed Previous Facility Lease obligation. This fundamental change in the intended use of certain assets required the Company to reassess its historical asset groupings, which resulted in a change from a single, entity-level asset group to multiple asset groups based on the lowest level of separately identifiable cash flows. The multiple new asset groups identified during the reassessment are described in detail below. As of June 29, 2020, the Company evaluated all of its long-lived assets for potential held for sale classification pursuant to policies described in Note 1—Organization and Significant Accounting Policies. The Company identified the following two disposal groups that met the criteria to be classified as held for sale within its consolidated balance sheets as of June 30, 2020: • The first disposal group consisted of furniture and equipment to be sold to the New Tenant pursuant to a bill of sale executed on July 16, 2020. The disposal group’s carrying value of $454 was compared to its estimated fair value less costs to sell of $265, resulting in an impairment charge of $189 recorded during the three months ended June 30, 2020. The selling price expected to be paid by the New Tenant to acquire the furniture and equipment disposal group was the best estimate of fair value, which the Company concluded was a Level 2 input within the fair value measurement hierarchy in FASB ASC 820, Fair Value Measurements . • The second disposal group consisted of certain manufacturing and laboratory equipment associated with the Company’s large scale drug manufacturing capability that the Company intended to sell through a consignment seller. The disposal group’s carrying value of $1,510 was compared to its estimated fair value less costs to sell of $712, resulting in an impairment charge of $798 recorded during the three months ended June 30, 2020. The estimated selling prices provided by the consignment seller were determined to be the best estimate of fair value, which the Company concluded were Level 3 inputs within the fair value measurement hierarchy. The Company assessed its remaining long-lived assets classified as held and used for potential impairment as of June 29, 2020 pursuant to the Company’s policy described in Note 1—Organization and Significant Accounting Policies, including those long-lived assets in the following two asset groups: • Right-of-use asset, leasehold improvements and other property affixed to the Previous Facility. This asset group, which had an aggregate carrying value of $8,227 as of June 29, 2020, consisted of a right-of-use asset associated with the Previous Facility Lease of $1,816, leasehold improvements and other property affixed to the Previous Facility of $5,872, and restricted cash that secured a letter of credit associated with the Previous Facility Lease of $539. Due to actions taken as of June 29, 2020, the Company committed to no longer use the asset group to support the Company’s future revenue-producing drug development operations. This significant change in the intended use of this asset group was considered an indicator of impairment that resulted in the performance of a recoverability test. The Company concluded that the asset group was not recoverable because the asset group’s carrying value exceeded its expected future undiscounted net cash flows, which were based on Company-specific facts and circumstances and included the economics of and costs associated with the lease termination transaction described in Note 8—Commitments and Contingencies, and thus, the Company identified a potential impairment. The Company then estimated the fair value of the asset group, which was based on fair value principles in FASB ASC 820, Fair Value Measurements and generally focuses on the value that a market participant would be willing to pay for the highest and best use of the asset group. The Company determined that the lease terms established in the New Tenant’s prime lease of the Previous Facility were representative of the asset group’s highest and best use and were consistent with market terms; therefore, such terms were considered to be the best available valuation inputs for the fair value estimate. Using a market average borrowing rate to discount the New Tenant’s prime lease payments, the Company estimated the fair value of the asset group to be $7,298 and, as a result, measured and recorded an impairment charge of $929 during the three months ended June 30, 2020. The inputs to the fair value estimate of this asset group were determined to be Level 3 inputs within the fair value measurement hierarchy. The Company determined that the June 30, 2020 carrying value of this asset group, as adjusted for the aforementioned impairment charge, was representative of its value to a market participant for its highest and best use, as required under the ASC 820 fair value model. • Other assets held and used. This asset group, which had an aggregate carrying value of $505 as of June 29, 2020, consisted of equipment and other property that was not directly associated with the Company’s continuing research, development and pilot scale drug manufacturing capabilities. The Company tested this asset group for recoverability because the Company intends to dispose of these assets significantly before the end of their previously estimated useful life, which is an impairment indicator. However, this asset group had not met the criteria to be classified as held for sale because the Company has not yet established a plan to sell these assets and is uncertain whether it will do so within the next twelve months. During the recoverability test, the Company determined that this asset group was unlikely to generate any material future cash flows for the Company. The Company further determined that a market participant was unlikely to pay any material value for such assets and, therefore, concluded that the fair value of this asset group was zero. As a result, the Company measured and recorded an impairment charge of $505 during the three months ended June 30, 2020. The inputs to the fair value estimate of this asset group were determined to be Level 3 inputs within the fair value measurement hierarchy. The Company’s then remaining long-lived assets, which include retained manufacturing and laboratory equipment with a carrying value of $744 that continued to support and enable the Company’s continuing research, development and pilot scale drug manufacturing capabilities, had no change to their intended use, no impairment indicators were identified, and no further assessment of recoverability was required. As noted above, during the quarterly period ended June 30, 2020, the Company recognized within its accompanying consolidated statements of operations and comprehensive loss an impairment loss on long-lived assets totaling $2,421. During the fourth quarter of 2020, certain equipment assets that the Company had previously classified as held for sale during the aforementioned June 29, 2020 evaluation were reclassified as held and used. The reclassification determination was based upon new facts and circumstances that enabled the Company to re-use the equipment in connection with the planned build-out of the Company’s newly leased facility in Durham, North Carolina. While classified as held for sale, these assets had been carried at their aggregate fair value less costs to sell of $356. Upon reclassification to held and used, the Company avoided certain estimated selling costs that had been included in the previously recognized impairment charge during the quarterly period ended June 30, 2020 and, as a result, the Company recognized a $144 favorable adjustment to the impairment charge during the quarterly period ended December 31, 2020 for a total impairment charge of $114 for the year ended December 31, 2020. The reclassified assets were included in property and equipment, net, in the Company’s consolidated balance sheet at their aggregate fair value of $500. See Note 17—Asset Group Disposition for the additional loss recorded by the Company, which was based upon Company-specific facts and circumstances associated with the July 2020 lease termination transaction during the year ended December 31, 2020, rather than the market participant valuation model that was required to be used during the impairment assessment as of June 29, 2020. The Company conducted certain activities and engaged in certain transactions during the second and third quarters of 2020 that ultimately achieved relief from the remaining fixed Previous Facility Lease obligation. These activities and transactions had various accounting implications, which are described in detail within this Note and Note 16—Assets Held for Sale, Impairment Charges. On July 16, 2020, the Company entered into the lease termination transaction as described in Note 8—Commitments and Contingencies. Subsequent to July 16, 2020, the Company utilized a sublet premises within the Previous Facility to operate its corporate headquarters, research and development laboratories and pilot scale cGMP manufacturing activities, and did so prior to taking possession of its New Facility. The following events and transactions occurred during the year ended December 31, 2020 for the Company’s various disposal and asset groups, as described in Note 16—Assets Held for Sale, Impairment Charges: • Disposal groups classified as assets held for sale. ◦ The first disposal group, which consisted of furniture and equipment, was sold to the New Tenant pursuant to a bill of sale executed on July 16, 2020. The disposal group’s carrying value, net of an impairment charge recognized in the quarterly period ended June 30, 2020, was equal to the amount of proceeds received; therefore, no gain or loss was recognized on the disposition. ◦ The second disposal group, which consisted of certain manufacturing and laboratory equipment associated with the Company’s large scale drug manufacturing capability, was held for sale over time through a consignment seller. During the year ended December 31, 2020, the Company received aggregate net proceeds of $242 from the sale of certain assets within this disposal group, with no gain or loss recognized. During the fourth quarter of 2020, the Company determined certain assets in this disposal group would be re-used by the Company rather than sold by the consignment seller. As a result, such assets, which had an aggregate fair value less cost to sell of $356, were reclassified and presented as held and used as of December 31, 2020. As of December 31, 2020, the Company had $114 of disposal group carrying value remaining. During the second quarter of 2021, the Company assessed the disposal group for recoverability and determined that the remaining carrying value of the disposal group had no fair value. As a result of this assessment, the Company recorded an impairment charge of $114 during the three months ended June 30, 2021. • Long-lived asset groups classified as held and used. ◦ Right-of-use asset, leasehold improvements and other property affixed to the Previous Facility, restricted cash and lease liabilities associated with the Previous Facility Lease . In conjunction with the lease termination transaction as described in Note 8—Commitments and Contingencies, all assets and liabilities within this asset group were disposed of on July 16, 2020. As of the disposition date, the aggregate carrying value of the assets was $7,257 and the aggregate carrying value of the associated lease liabilities was $5,951. The $1,306 net charge resulting from the write-off of these assets and liabilities was combined with $466 of other direct costs incurred in connection with the lease termination transaction to result in a $1,772 total loss on disposition. This loss, which is in addition to the impairment loss recognized during the quarterly period ended June 30, 2020 and described in Note 16—Assets Held for Sale, Impairment Charges, was based upon Company-specific facts and circumstances associated with the July 2020 lease termination transaction, rather than the market participant valuation model that was required to be used during the impairment assessment as of June 29, 2020. ◦ Remaining long-lived property and equipment assets. The Company’s remaining long-lived assets, which include retained manufacturing and laboratory equipment, continue to support and enable the Company’s continuing research, development and pilot scale drug manufacturing capabilities. The Company continued to account for these assets pursuant to its existing accounting policies, including recognition of additions and disposals occurring in the normal course and the continued depreciation based on estimated useful lives. The following table summarizes the loss on facility asset group disposition as presented within the accompanying consolidated statements of operations and comprehensive loss during the year ended December 31, 2020: Property and Equipment, net $ 4,902 Restricted cash (security deposit) 539 Right-of-use assets 1,816 Total facility group assets 7,257 Lease liabilities, current portion (1,169) Lease liabilities, net of current portion (4,782) Total facility group liabilities (5,951) Net carrying value of facility asset group $ 1,306 Other direct disposal costs 466 Loss on facility asset group disposition $ 1,772 |
Asset Group Disposition
Asset Group Disposition | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Asset Group Disposition | Assets Held for Sale, Impairment Charges The Company has pursued a broader strategic plan since 2019 to shift its operating cost structure characteristics from fixed to variable, including efforts to reduce or offset its fixed Previous Facility Lease obligation. The Previous Facility once served as the Company’s corporate headquarters and its sole research, development and manufacturing facility. The Company conducted certain activities and engaged in certain transactions during the second and third quarters of 2020 that ultimately achieved relief from the remaining fixed Previous Facility Lease obligation. These activities and transactions had various accounting implications, which are described in detail within this Note and Note 17—Asset Group Disposition. Following the completion of a large scale manufacturing campaign that produced clinical trial materials for the Company’s B-SIMPLE4 Phase 3 study for SB206 in May 2020, and in contemplation of the lease termination transaction described in Note 8—Commitments and Contingencies, the Company initiated decommissioning of the Previous Facility in June 2020, and, on June 29, 2020, the physical removal of the primary components of the large scale manufacturing process equipment from the Previous Facility was deemed substantially complete. As a result of these decommissioning actions, the Company determined that, as of June 29, 2020, the Company had fundamentally changed its intended use of the Previous Facility and certain related assets, including (i) the removal of the Company’s large scale cGMP drug manufacturing capability and (ii) the conditioning of the Previous Facility to facilitate a transaction that would reduce or offset the Company’s remaining fixed Previous Facility Lease obligation. This fundamental change in the intended use of certain assets required the Company to reassess its historical asset groupings, which resulted in a change from a single, entity-level asset group to multiple asset groups based on the lowest level of separately identifiable cash flows. The multiple new asset groups identified during the reassessment are described in detail below. As of June 29, 2020, the Company evaluated all of its long-lived assets for potential held for sale classification pursuant to policies described in Note 1—Organization and Significant Accounting Policies. The Company identified the following two disposal groups that met the criteria to be classified as held for sale within its consolidated balance sheets as of June 30, 2020: • The first disposal group consisted of furniture and equipment to be sold to the New Tenant pursuant to a bill of sale executed on July 16, 2020. The disposal group’s carrying value of $454 was compared to its estimated fair value less costs to sell of $265, resulting in an impairment charge of $189 recorded during the three months ended June 30, 2020. The selling price expected to be paid by the New Tenant to acquire the furniture and equipment disposal group was the best estimate of fair value, which the Company concluded was a Level 2 input within the fair value measurement hierarchy in FASB ASC 820, Fair Value Measurements . • The second disposal group consisted of certain manufacturing and laboratory equipment associated with the Company’s large scale drug manufacturing capability that the Company intended to sell through a consignment seller. The disposal group’s carrying value of $1,510 was compared to its estimated fair value less costs to sell of $712, resulting in an impairment charge of $798 recorded during the three months ended June 30, 2020. The estimated selling prices provided by the consignment seller were determined to be the best estimate of fair value, which the Company concluded were Level 3 inputs within the fair value measurement hierarchy. The Company assessed its remaining long-lived assets classified as held and used for potential impairment as of June 29, 2020 pursuant to the Company’s policy described in Note 1—Organization and Significant Accounting Policies, including those long-lived assets in the following two asset groups: • Right-of-use asset, leasehold improvements and other property affixed to the Previous Facility. This asset group, which had an aggregate carrying value of $8,227 as of June 29, 2020, consisted of a right-of-use asset associated with the Previous Facility Lease of $1,816, leasehold improvements and other property affixed to the Previous Facility of $5,872, and restricted cash that secured a letter of credit associated with the Previous Facility Lease of $539. Due to actions taken as of June 29, 2020, the Company committed to no longer use the asset group to support the Company’s future revenue-producing drug development operations. This significant change in the intended use of this asset group was considered an indicator of impairment that resulted in the performance of a recoverability test. The Company concluded that the asset group was not recoverable because the asset group’s carrying value exceeded its expected future undiscounted net cash flows, which were based on Company-specific facts and circumstances and included the economics of and costs associated with the lease termination transaction described in Note 8—Commitments and Contingencies, and thus, the Company identified a potential impairment. The Company then estimated the fair value of the asset group, which was based on fair value principles in FASB ASC 820, Fair Value Measurements and generally focuses on the value that a market participant would be willing to pay for the highest and best use of the asset group. The Company determined that the lease terms established in the New Tenant’s prime lease of the Previous Facility were representative of the asset group’s highest and best use and were consistent with market terms; therefore, such terms were considered to be the best available valuation inputs for the fair value estimate. Using a market average borrowing rate to discount the New Tenant’s prime lease payments, the Company estimated the fair value of the asset group to be $7,298 and, as a result, measured and recorded an impairment charge of $929 during the three months ended June 30, 2020. The inputs to the fair value estimate of this asset group were determined to be Level 3 inputs within the fair value measurement hierarchy. The Company determined that the June 30, 2020 carrying value of this asset group, as adjusted for the aforementioned impairment charge, was representative of its value to a market participant for its highest and best use, as required under the ASC 820 fair value model. • Other assets held and used. This asset group, which had an aggregate carrying value of $505 as of June 29, 2020, consisted of equipment and other property that was not directly associated with the Company’s continuing research, development and pilot scale drug manufacturing capabilities. The Company tested this asset group for recoverability because the Company intends to dispose of these assets significantly before the end of their previously estimated useful life, which is an impairment indicator. However, this asset group had not met the criteria to be classified as held for sale because the Company has not yet established a plan to sell these assets and is uncertain whether it will do so within the next twelve months. During the recoverability test, the Company determined that this asset group was unlikely to generate any material future cash flows for the Company. The Company further determined that a market participant was unlikely to pay any material value for such assets and, therefore, concluded that the fair value of this asset group was zero. As a result, the Company measured and recorded an impairment charge of $505 during the three months ended June 30, 2020. The inputs to the fair value estimate of this asset group were determined to be Level 3 inputs within the fair value measurement hierarchy. The Company’s then remaining long-lived assets, which include retained manufacturing and laboratory equipment with a carrying value of $744 that continued to support and enable the Company’s continuing research, development and pilot scale drug manufacturing capabilities, had no change to their intended use, no impairment indicators were identified, and no further assessment of recoverability was required. As noted above, during the quarterly period ended June 30, 2020, the Company recognized within its accompanying consolidated statements of operations and comprehensive loss an impairment loss on long-lived assets totaling $2,421. During the fourth quarter of 2020, certain equipment assets that the Company had previously classified as held for sale during the aforementioned June 29, 2020 evaluation were reclassified as held and used. The reclassification determination was based upon new facts and circumstances that enabled the Company to re-use the equipment in connection with the planned build-out of the Company’s newly leased facility in Durham, North Carolina. While classified as held for sale, these assets had been carried at their aggregate fair value less costs to sell of $356. Upon reclassification to held and used, the Company avoided certain estimated selling costs that had been included in the previously recognized impairment charge during the quarterly period ended June 30, 2020 and, as a result, the Company recognized a $144 favorable adjustment to the impairment charge during the quarterly period ended December 31, 2020 for a total impairment charge of $114 for the year ended December 31, 2020. The reclassified assets were included in property and equipment, net, in the Company’s consolidated balance sheet at their aggregate fair value of $500. See Note 17—Asset Group Disposition for the additional loss recorded by the Company, which was based upon Company-specific facts and circumstances associated with the July 2020 lease termination transaction during the year ended December 31, 2020, rather than the market participant valuation model that was required to be used during the impairment assessment as of June 29, 2020. The Company conducted certain activities and engaged in certain transactions during the second and third quarters of 2020 that ultimately achieved relief from the remaining fixed Previous Facility Lease obligation. These activities and transactions had various accounting implications, which are described in detail within this Note and Note 16—Assets Held for Sale, Impairment Charges. On July 16, 2020, the Company entered into the lease termination transaction as described in Note 8—Commitments and Contingencies. Subsequent to July 16, 2020, the Company utilized a sublet premises within the Previous Facility to operate its corporate headquarters, research and development laboratories and pilot scale cGMP manufacturing activities, and did so prior to taking possession of its New Facility. The following events and transactions occurred during the year ended December 31, 2020 for the Company’s various disposal and asset groups, as described in Note 16—Assets Held for Sale, Impairment Charges: • Disposal groups classified as assets held for sale. ◦ The first disposal group, which consisted of furniture and equipment, was sold to the New Tenant pursuant to a bill of sale executed on July 16, 2020. The disposal group’s carrying value, net of an impairment charge recognized in the quarterly period ended June 30, 2020, was equal to the amount of proceeds received; therefore, no gain or loss was recognized on the disposition. ◦ The second disposal group, which consisted of certain manufacturing and laboratory equipment associated with the Company’s large scale drug manufacturing capability, was held for sale over time through a consignment seller. During the year ended December 31, 2020, the Company received aggregate net proceeds of $242 from the sale of certain assets within this disposal group, with no gain or loss recognized. During the fourth quarter of 2020, the Company determined certain assets in this disposal group would be re-used by the Company rather than sold by the consignment seller. As a result, such assets, which had an aggregate fair value less cost to sell of $356, were reclassified and presented as held and used as of December 31, 2020. As of December 31, 2020, the Company had $114 of disposal group carrying value remaining. During the second quarter of 2021, the Company assessed the disposal group for recoverability and determined that the remaining carrying value of the disposal group had no fair value. As a result of this assessment, the Company recorded an impairment charge of $114 during the three months ended June 30, 2021. • Long-lived asset groups classified as held and used. ◦ Right-of-use asset, leasehold improvements and other property affixed to the Previous Facility, restricted cash and lease liabilities associated with the Previous Facility Lease . In conjunction with the lease termination transaction as described in Note 8—Commitments and Contingencies, all assets and liabilities within this asset group were disposed of on July 16, 2020. As of the disposition date, the aggregate carrying value of the assets was $7,257 and the aggregate carrying value of the associated lease liabilities was $5,951. The $1,306 net charge resulting from the write-off of these assets and liabilities was combined with $466 of other direct costs incurred in connection with the lease termination transaction to result in a $1,772 total loss on disposition. This loss, which is in addition to the impairment loss recognized during the quarterly period ended June 30, 2020 and described in Note 16—Assets Held for Sale, Impairment Charges, was based upon Company-specific facts and circumstances associated with the July 2020 lease termination transaction, rather than the market participant valuation model that was required to be used during the impairment assessment as of June 29, 2020. ◦ Remaining long-lived property and equipment assets. The Company’s remaining long-lived assets, which include retained manufacturing and laboratory equipment, continue to support and enable the Company’s continuing research, development and pilot scale drug manufacturing capabilities. The Company continued to account for these assets pursuant to its existing accounting policies, including recognition of additions and disposals occurring in the normal course and the continued depreciation based on estimated useful lives. The following table summarizes the loss on facility asset group disposition as presented within the accompanying consolidated statements of operations and comprehensive loss during the year ended December 31, 2020: Property and Equipment, net $ 4,902 Restricted cash (security deposit) 539 Right-of-use assets 1,816 Total facility group assets 7,257 Lease liabilities, current portion (1,169) Lease liabilities, net of current portion (4,782) Total facility group liabilities (5,951) Net carrying value of facility asset group $ 1,306 Other direct disposal costs 466 Loss on facility asset group disposition $ 1,772 |
Organization and Significant _2
Organization and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Additionally, the report of the Company’s independent registered public accounting firm (PCAOB ID #243) on the Company’s consolidated financial statements as of and for the year ended December 31, 2021, included an explanatory paragraph indicating that there is substantial doubt about the Company’s ability to continue as a going concern, as further discussed below. |
Basis of Consolidation | Basis of Consolidation The accompanying consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Reverse Stock Split | Reverse Stock Split On May 25, 2021, the Company amended its restated certificate of incorporation effecting a 1-for-10 reverse stock split of its outstanding shares of capital stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of capital stock of the Company or cause an adjustment to the par value of the Company's capital stock. As a result of the Reverse Stock Split, the Company adjusted (i) the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, warrants to purchase shares of common stock and stock appreciation rights, (ii) the share price targets of the Company’s Tangible Stockholder Return Plan and (iii) the number of shares reserved for issuance pursuant to the Company’s equity incentive compensation plans. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who would have otherwise held a fractional share of capital stock received a cash payment for any fractional share resulting from the Reverse Stock Split in an amount equal to such fraction multiplied by the closing sales price of the common stock as reported on the Nasdaq Stock Market on May 25, 2021, the last trading day immediately prior to the effectiveness of the Reverse Stock Split. See Note 10—Stockholders’ Equity (Deficit) for further information regarding the Reverse Stock Split. All disclosures of shares and per share data in the consolidated financial statements and related notes have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented, and certain amounts within the consolidated balance sheets and consolidated statements of stockholders’ equity (deficit) were reclassified between common stock and additional paid-in capital. |
Liquidity and Ability to Continue as a Going Concern | Liquidity and Ability to Continue as a Going Concern The Company’s consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern. The Company has evaluated principal conditions and events, in the aggregate, that may raise substantial doubt about its ability to continue as a going concern within one year from the date that these financial statements are issued. The Company identified the following conditions: • The Company has reported a net loss in all fiscal periods since inception and, as of December 31, 2021, the Company had an accumulated deficit of $278,969. • As of December 31, 2021, the Company had a total cash and cash equivalents balance of $47,085. • As described in Note 10—Stockholders’ Equity (Deficit), in June 2021 the Company completed a public offering of its common stock pursuant to the Company’s shelf registration statement (the “June 2021 Public Offering”). Net proceeds from the offering were approximately $37,236 after deducting underwriting discounts and commissions and offering expenses of approximately $2,764. • As described in Note 10—Stockholders’ Equity (Deficit), in July 2020 the Company entered into a common stock purchase agreement (the “July 2020 Aspire CSPA”) with Aspire Capital Fund, LLC (“Aspire Capital”). The July 2020 Aspire CSPA replaced the prior common stock purchase agreement, dated as of June 15, 2020, between the Company and Aspire Capital (the “June 2020 Aspire CSPA”), which was fully utilized. During the year ended December 31, 2021, the Company received aggregate net proceeds of $6,334 from sales under the July 2020 Aspire CSPA and, as of December 31, 2021, had $12,005 in remaining availability for sales of its common stock under the July 2020 Aspire CSPA, subject to certain limitations. • The Company anticipates that it will continue to generate losses for the foreseeable future, and it expects the losses to increase as it continues the development of, and seeks regulatory approvals for, its product candidates and begins activities to prepare for potential commercialization. • The Company has concluded that the prevailing conditions and ongoing liquidity risks faced by the Company, coupled with its current forecasts, including costs associated with implementing the SB206 prelaunch strategy and commercial preparation, raise substantial doubt about its ability to continue as a going concern. This evaluation is also based on other relevant conditions that are known or reasonably knowable at the date that the financial statements are issued, including ongoing liquidity risks faced by the Company, the Company’s conditional and unconditional obligations due or anticipated within one year, the funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows, and other conditions and events that, when considered in conjunction with the above, may adversely affect the Company’s ability to meet its obligations. The Company will continue to evaluate this going concern assessment in connection with the preparation of its quarterly and annual financial statements based upon relevant facts and circumstances, including but not limited to, its cash and cash equivalents balance and its operating forecast and related cash projection. Based on the Company’s operating forecast, it believes that its existing cash and cash equivalents balance as of December 31, 2021, plus expected contractual payments to be received in connection with existing licensing agreements, will not provide it with adequate liquidity for one year from the date of the issuance of the consolidated financial statements. This operating forecast and related cash projection includes: (i) costs associated with preparing for and seeking U.S. regulatory approval of SB206 as a treatment for molluscum, including costs to prepare for a pre-NDA meeting with the FDA and NDA-enabling drug stability studies for SB206; (ii) costs associated with the completion and readiness of its new corporate headquarters and manufacturing capability necessary to support small-scale drug substance and drug product manufacturing; (iii) conducting drug manufacturing activities with external third-party contract manufacturing organizations (“CMOs”), including a drug delivery device technology enhancement project; (iv) developmental and regulatory activities for its SB019 program (Coronaviridae (COVID-19)), including a Phase 1 study, targeted for conduct in 2022; (v) preparatory activities for a potential Phase 3 study, targeted for initiation in 2023, related to SB204 as a treatment for acne; and (vi) initial efforts to support potential commercialization of SB206, but excludes: (a) any potential costs associated with other late-stage clinical programs, including executing the potentially registrational Phase 3 study of SB204 for acne; (b) progression of the SB019 program subsequent to execution of a Phase 1 study; (c) operating costs that could occur between a potential NDA submission for SB206 through NDA approval, specifically including marketing and commercialization efforts to achieve potential launch of SB206; and (d) proceeds from any potential future sales of common stock under the July 2020 Aspire CSPA. The Company may decide to revise its development and operating plans or the related timing, depending on information it learns through its research and development activities, including regulatory submission efforts related to SB206, potential commercialization strategies, the impact of outside factors such as the COVID-19 pandemic, its ability to enter into strategic arrangements or other transactions, its ability to access additional capital and its financial priorities. The Company will need significant additional funding to continue its operating activities, make further advancements in its product development programs and potentially commercialize any of its product candidates beyond those activities currently included in its operating forecast and related cash projection. The Company does not currently have sufficient funds to commercialize any of its product candidates, if approved, and its funding needs will largely be determined by its commercialization strategy for SB206, subject to NDA submission timing and the regulatory approval process. The Company has engaged Syneos Health, a fully integrated biopharmaceutical solutions organization, as its commercial solutions provider for SB206. The Company’s relationship with Syneos Health will focus on implementing the SB206 prelaunch strategy and commercial preparation, if approved by the U.S. Food and Drug Administration. The inability of the Company to obtain significant additional funding on acceptable terms, including through the utilization of the remaining amount available under the July 2020 Aspire CSPA, could have a material adverse effect on the Company’s business and cause the Company to alter or reduce its planned operating activities, including but not limited to delaying, reducing, terminating or eliminating planned product candidate development activities, to conserve its cash and cash equivalents. The Company may pursue additional capital through equity or debt financings, including potential sales under the July 2020 Aspire CSPA, or from non-dilutive sources, including partnerships, collaborations, licensing, grants or other strategic relationships. The Company’s anticipated expenditure levels may change if it adjusts its current operating plan. Such actions could delay development timelines and have a material adverse effect on its business, results of operations, financial condition and market valuation. The Company’s equity issuances during the year ended December 31, 2021 and 2020, have resulted in significant dilution to its existing stockholders. Any future additional issuances of equity, or debt convertible into equity, would result in further significant dilution to the Company’s existing stockholders. As of December 31, 2021 the Company had 18,815,892 shares of common stock outstanding. In addition, as of December 31, 2021, the Company had reserved 3,065,953 shares of common stock for future issuance related to (i) outstanding warrants to purchase common stock; (ii) outstanding stock options and stock appreciation rights; and (iii) future issuance under the 2016 Incentive Award Plan. As of December 31, 2021, the Company’s common stock consists of 200,000,000 authorized shares. The Company is also exploring the potential for strategic transactions, such as strategic acquisitions or in-licenses, sales or divestitures of some of its assets, or other potential strategic transactions, which could include a sale of the Company. If the Company were to pursue such a transaction, it may not be able to complete the transaction on a timely basis or at all or on terms that are favorable to the Company. Alternatively, if the Company is unable to obtain significant additional funding on acceptable terms or progress with a strategic transaction, it could instead determine to dissolve and liquidate its assets or seek protection under the bankruptcy laws. If the Company decides to dissolve and liquidate its assets or to seek protection under the bankruptcy laws, it is unclear to what extent the Company will be able to pay its obligations, and, accordingly, it is further unclear whether and to what extent any resources will be available for distributions to stockholders. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from these estimates. |
Reclassifications | Reclassifications Certain amounts in the Company’s consolidated balance sheet as of December 31, 2020 have been reclassified to conform to current presentation related to deferred offering costs in the amount of $58 being included with prepaid expenses and other current assets. These reclassifications had no impact on the Company’s consolidated current assets or on the consolidated statements of operations and comprehensive loss or cash flows for the year ended December 31, 2020. Certain amounts in the Company’s consolidated balance sheet as of December 31, 2020 have been reclassified to conform t o current presentation related to the May 25, 2021 Reverse Stock Split. The reclassified amount between common stock and additional paid-in capital was $13 as of |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid instruments purchased with a maturity of three months or less to be cash equivalents. Cash and cash equivalents include deposits and money market accounts. |
Restricted Cash | Restricted CashRestricted cash as of December 31, 2021 includes funds maintained in a deposit account to secure a letter of credit for the benefit of the New Landlord |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist principally of cash and cash equivalents. The Company places its cash and cash equivalents with financial institutions and these deposits may at times be in excess of insured limits. |
Contracts and Grants Receivable | Contracts and Grants ReceivableThe Company carries its contracts and grants receivable net of an allowance for doubtful accounts. All receivables or portions thereof that are deemed to be uncollectible or that require excessive collection costs are written off to the allowance for doubtful accounts when it is probable that the receivable is unrecoverable. The Company actively reviews and evaluates its contracts and grants receivable, but no allowance for doubtful accounts has been considered necessary as of December 31, 2021 or 2020. Actual results could differ from the estimates that were used. |
Intangible Assets | Intangible Assets Intangible assets represent the cost to obtain and register the Company’s internet domain. Indefinite-lived intangible assets are not amortized and are assessed for impairment at least annually. |
Property and Equipment | Property and EquipmentLeasehold improvements are amortized over the shorter of the life of the lease or the useful life of the improvements. Expenditures for maintenance and repairs are expensed as incurred. Improvements and betterments that add new functionality or extend the useful life of an asset are capitalized. Leases for real estate often include tenant improvement allowances, which the Company assesses according to applicable accounting guidance to determine the appropriate owner, and capitalizes such tenant improvement assets accordingly. |
Intellectual Property | Intellectual Property The Company’s policy is to file patent applications to protect technology, inventions and improvements that are considered important to its business. Patent positions, including those of the Company, are uncertain and involve complex legal and factual questions for which important legal principles are largely unresolved. Due to the uncertainty of future value to be realized from the expenses incurred in developing the Company’s intellectual property, the cost of filing, prosecuting and maintaining internally developed patents are expensed as general and administrative costs as incurred. |
Leases | Leases The Company leases office space and certain equipment under non-cancelable lease agreements. The Company applies the accounting guidance in ASC 842, Leases. As such, the Company assesses all arrangements, that convey the right to control the use of property, plant and equipment, at inception, to determine if it is, or contains, a lease based on the unique facts and circumstances present in that arrangement. For those leases identified, the Company determines the lease classification, recognition, and measurement at the lease commencement date. For arrangements that contain a lease the Company: (i) identifies lease and non-lease components; (ii) determines the consideration in the contract; (iii) determines whether the lease is an operating or financing lease; and (iv) recognizes lease Right of Use (“ROU”) assets and corresponding lease liabilities. Lease liabilities are recorded based on the present value of lease payments over the expected lease term. The corresponding ROU asset is measured from the initial lease liability, adjusted by (i) accrued or prepaid rents; (ii) remaining unamortized initial direct costs and lease incentives; and (iii) any impairments of the ROU asset. The Company elected the practical expedient to not separate non-lease components from the lease components. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Variable lease expenses that are not considered fixed are expensed as incurred. Fixed and variable lease expense on operating leases is recognized within operating expenses within the accompanying consolidated statements of operations and comprehensive loss. The Company has elected the short-term lease exemption and, therefore, does not recognize an ROU asset or corresponding liability for lease arrangements with an original term of 12 months or less. The interest rate implicit in the Company’s lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. In accordance with ASC 842, Leases (Topic 842), arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease, if available, otherwise at the Company’s incremental borrowing rate. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. |
Assets Held for Sale and Impairment of Long-lived Assets | Assets Held for Sale The Company generally considers assets to be held for sale when (i) the Company commits to a plan to sell the assets, (ii) the assets are available for immediate sale in their present condition, (iii) the Company has initiated an active program to locate a buyer and other actions required to complete the plan to sell the assets, (iv) consummation of the planned sale transaction is probable, (v) the assets are being actively marketed for sale at a price that is reasonable in relation to their current fair value, (vi) the transaction is expected to qualify for recognition as a completed sale, within one year, and (vii) significant changes to or withdrawal of the plan is unlikely. Following the classification of any depreciable assets within a disposal group as held for sale, the Company discontinues depreciating the asset and writes down the asset to the lower of carrying value or fair market value less cost to sell, if needed. See Note 16—Assets Held for Sale, Impairment Charges for a discussion of the Company’s application of this accounting policy. Impairment of Long-Lived Assets |
Revenue Recognition | Revenue Recognition The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers . To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contracts with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and 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. Upon occurrence of a contract modification, the Company conducts an evaluation pursuant to the modification framework in Topic 606 to determine the appropriate revenue recognition. The framework centers around key questions, including (i) whether the modification adds additional goods and services, (ii) whether those goods and services are distinct, and (iii) whether the contract price increases by an amount that reflects the standalone selling price for the new goods or services. The resulting conclusions will determine whether the modification is treated as a separate, standalone contract or if it is combined with the original contract and accounted for in that manner. In addition, some modifications are accounted for on a prospective basis and others on a cumulative catch-up basis. The Company’s agreements may contain some or all the following types of provisions or payments: Licenses of Intellectual Property : If the license of the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the estimated performance period and the appropriate method of measuring progress during the performance period for purposes of recognizing revenue. The Company re-evaluates the estimated performance period and measure of progress each reporting period and, if necessary, adjusts related revenue recognition accordingly. Milestone Payments : At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. 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 its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and collaboration revenue and earnings in the period of adjustment. Manufacturing Supply Services : Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in license and collaboration revenue when the customer obtains control of the goods, which is upon delivery. Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and 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). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. See Note 5—Revenue Recognition for information regarding the Company’s license agreements. The Company’s revenue also includes research revenue earned under contracts and grants with Federal government agencies, which relates to the research and development of its nitric oxide platform. Government research contracts and grants revenue . Under the terms of the contracts and grants awarded, the Company is entitled to receive reimbursement of its allowable direct expenses, allocated overhead, general and administrative expenses and payment of other specified amounts. Revenues from development and support activities under government research contracts and grants are recorded in the period in which the related costs are incurred. Associated expenses are recognized when incurred as research and development expense. Revenue recognized in excess of amounts collected from funding sources are recorded as contracts and grants receivable. Any of the funding sources may, at their discretion, request reimbursement for expenses or return of funds, or both, as a result of noncompliance by the Company with the terms of the grants. No reimbursement of expenses or return of funds has been requested or made since inception of the contracts and grants. See Note 5—Revenue Recognition for information regarding government grants. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include all direct and indirect development costs incurred for the development of the Company’s drug candidates. These expenses include salaries and related costs, including stock-based compensation and travel costs for research and development personnel, allocated facility costs, laboratory and manufacturing materials and supplies, consulting fees, product development, preclinical studies, clinical trial costs, licensing fees and milestone payments under license agreements and other fees and costs related to the development of drug candidates. The cost of tangible and intangible assets that are acquired for use on a particular research and development project, have no alternative future uses, and are not required to be capitalized in accordance with the Company’s capitalization policy, are expensed as research and development costs as incurred. |
Accrued Outside Research and Development Expense Accruals | Accrued Outside Research and Development Accruals The Company is required to estimate its expenses resulting from its obligations under contracts with clinical research organizations, clinical site agreements, vendors, and consultants in connection with conducting clinical trials and preclinical development. The financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate development and clinical trial expenses in its financial statements by matching those expenses with the period in which the services and efforts are expended. For clinical trials, the Company accounts for these expenses according to the progress of the trial as measured by actual hours expended by contract research organization personnel, investigator performance or completion of specific tasks, patient progression, or timing of various aspects of the trial. During the course of a clinical trial, the Company adjusts its rate of clinical trial expense recognition if actual results differ from its estimates. The Company utilizes judgment and experience to estimate its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in increases or decreases in research and development expenses in future periods when the actual results become known. For preclinical development services performed by outside service providers, the Company determines accrual estimates through financial models, considering development progress data received from outside service providers and discussions with applicable Company and service provider personnel. |
Classification of Warrants Issued in Connection with Offerings of Common Stock | Classification of Warrants Issued in Connection with Offerings of Common Stock The Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, whether the warrants meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and remeasured each balance sheet date thereafter. Changes in the estimated fair value of the liability-classified warrants are recognized as a non-cash gain or loss in the accompanying consolidated statements of operations and comprehensive loss. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying values of cash equivalents, contracts and grants receivable, accounts payable and accrued liabilities as of December 31, 2021 and 2020 approximated their fair values due to the short-term nature of these items. The Company has categorized its financial instruments, based on the priority of the inputs used to value the investments, into a three-level fair value hierarchy. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). If the inputs used to measure the investments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant to the fair value measurement of the investment. Financial instruments recorded in the accompanying consolidated balance sheets are categorized based on the inputs to valuation techniques as follows: Level 1 - Observable inputs that reflect unadjusted quoted market prices for identical assets or liabilities in active markets. Level 2 - Observable inputs other than Level 1 that are observable, either directly or indirectly, in the marketplace for identical or similar assets and liabilities. Level 3 - Unobservable inputs that are supported by little or no market data, where values are derived from techniques in which one or more significant inputs are unobservable. |
Stock-Based Compensation | Stock-Based Compensation Equity-Based Awards The Company applies the fair value method of accounting for stock-based compensation, which requires all such compensation to employees, including the grant of employee stock options, to be recognized in the accompanying consolidated statements of operations and comprehensive loss based on its fair value at the measurement date (generally the grant date). The expense associated with stock-based compensation is recognized over the requisite service period of each award. For awards with only service conditions and graded-vesting features, the Company recognizes compensation cost on a straight-line basis over the requisite service period. Stock-based awards granted to non-employee directors as compensation for serving on the Company’s board of directors are accounted for in the same manner as employee stock-based compensation awards. The fair value of each option grant is estimated using a Black-Scholes option-pricing model on the grant date using expected volatility, risk-free interest rate, expected life of options and fair value per share assumptions. Due to limited historical data, the Company estimates stock price volatility based on the actual volatility of comparable publicly traded companies over the expected life of the option. In evaluating similarity, the Company considered factors such as industry, stage of life cycle, financial leverage, size and risk profile. The Company does not have sufficient stock option exercise history to estimate the expected term of employee stock options and thus continues to calculate expected life based on the mid-point between the vesting date and the contractual term, which is in accordance with the simplified method. The expected term for stock-based compensation granted to non-employees is the contractual life. The risk-free rate is based on the United States Treasury yield curve during the expected life of the option. The Company estimates forfeitures based on the historical experience of the Company and adjusts the estimated forfeiture rate based upon actual experience. Liability-Based Awards Stock appreciation rights (“SARs”) that include cash settlement features are accounted for as liability-based awards pursuant to ASC 718 Share Based Payments . The fair value of such SARs is estimated using a Black-Scholes option-pricing model on each financial reporting date using expected volatility, risk-free interest rate, expected life and fair value per share assumptions. The fair value of obligations under the Tangible Stockholder Return Plan are estimated using a Monte Carlo simulation approach. The Company’s common stock price is simulated under the Geometric Brownian Motion framework under each simulation path. The other assumptions for the Monte Carlo simulation include the risk-free interest rate, estimated volatility and the expected term. The fair value of each liability award is estimated with a valuation model that uses certain assumptions, such as the award date, expected volatility, risk-free interest rate, expected life of the award and fair value per share assumptions. The Company estimates stock price volatility based on either (i) the actual volatility of comparable publicly traded companies over the expected term, considering factors such as industry, stage of life cycle, financial leverage, size and risk profile or (ii) the Company’s actual historical volatility over a historical period equal to the expected remaining life of the award, if such historical data is available. The expected term for liability-based awards is the estimated contractual life. The risk-free rate is based on the United States Treasury yield curve during the expected life of the award. ASC 718 requires that a liability-based award should be classified as a liability on the Company’s accompanying consolidated balance sheets and the amount of compensation cost recognized should be based on the fair value of the liability. When a liability-based award includes both a service and market condition, the market condition is taken into account when determining the appropriate method to estimate fair value and the compensation cost is amortized over the estimated service period. Therefore, the liability associated with the Performance Plan obligation is recorded within other long-term liabilities on the accompanying consolidated balance sheets at the estimated fair value on the date of issuance and is re-valued each subsequent reporting period end. The Company recognizes stock-based compensation expense within operating expenses in the accompanying consolidated statements of operations and comprehensive loss, including adjustments to the fair value of the liability-based award, on a straight-line basis over the requisite service period. The fair value of obligations under the Performance Plan are estimated using a Monte Carlo simulation approach. The Company’s common stock price is simulated under the Geometric Brownian Motion framework under each simulation path. The other assumptions for the Monte Carlo simulation include the risk-free interest rate, estimated volatility and the expected term. Expected stock price volatility is based on the Company’s actual historical volatility over a historical period equal to the expected remaining life of the plan, adjusted for certain market considerations and other factors. The fair value of the underlying common stock is the published closing market price on the Company’s principal market, which is currently the Nasdaq Capital Market, as of each reporting date, as adjusted for significant results, as necessary (if applicable). The risk-free interest rate is based on the United States Treasury yield curve in effect on the date of valuation equal to the remaining expected life of the plan. The dividend yield percentage is zero because the Company does not currently pay dividends, nor does it intend to do so during the expected term of the plan. The expected life of bonus awards under the Performance Plan is assumed to be equivalent to the remaining contractual term based on the estimated service period including the service inception date of the plan participants and the contractual end of the Performance Plan. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are determined based on the temporary differences between the financial statement carrying amounts and the tax bases of assets and liabilities using the enacted tax rates in effect in the years in which the differences are expected to reverse. In estimating future tax consequences, all expected future events are considered other than enactment of changes in the tax law or rates. The Company did not record a federal or state income tax benefit for the years ended December 31, 2021 and 2020 due to its conclusion that a full valuation allowance is required against the Company’s deferred tax assets. The determination of recording or releasing a tax valuation allowance is made, in part, pursuant to an assessment performed by management regarding the likelihood that the Company will generate future taxable income against which benefits of its deferred tax assets may or may not be realized. This assessment requires management to exercise judgment and make estimates with respect to its ability to generate taxable income in future periods. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The Company’s policy for recording interest and penalties is to record them as a component of general and administrative expenses. As of December 31, 2021 and 2020, the Company accrued no interest and penalties related to uncertain tax positions. Tax years 2018-2020 remain open to examination by the major taxing jurisdictions to which the Company is subject. Additionally, years prior to 2018 are also open to examination to the extent of loss and credit carryforwards from those years. In accordance with Section 382 of the Internal Revenue Code of 1986, as amended, a change in equity ownership of greater than 50% within a three-year period results in an annual limitation on the Company’s ability to utilize its net operating loss carryforwards and general business credits, including the research and development credits, created during the tax periods prior to the change in ownership. During the course of preparing the Company’s consolidated financial statements as of and for the year ended December 31 2021, the Company completed an Internal Revenue Code Section 382 and 383 analysis of its historical net operating loss and tax credit carryforward amounts. As a result, a portion of the prior year net operating loss and tax credit carryforwards were determined to be limited. See Note 13—Income Taxes, for further details. If the Company experiences another change in equity ownership which exceeds the Section 382 threshold, the Company’s net operating loss carryforwards and research and development credits may be subject to additional limitations. |
Comprehensive Loss | Comprehensive LossComprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. |
Net Loss Per Share | Net Loss Per ShareBasic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. |
Segment and Geographic Information | Segment and Geographic Information The Company has determined that it operates in one segment. The Company uses its nitric oxide-based technology to develop product candidates. The Chief Executive Officer, who is the Company’s chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. The Company has only had limited revenue since its inception, but substantially all revenue was derived from licensing agreements originating in the United States. All of the Company’s long-lived assets are maintained in the United States |
Recently Issued Accounting Standards | Recently Issued Accounting Standards Accounting Pronouncements Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This guidance is intended to improve consistent application of and simplify the accounting for income taxes. This ASU removes certain exceptions to the general principles in Topic 740 and clarifies and amends existing guidance. This standard is effective for annual reporting periods beginning after December 15, 2020, including interim reporting periods within those annual reporting periods, with early adoption permitted. This ASU was effective for the Company as of January 1, 2021. The adoption of this new accounting guidance did not have a material impact on the Company’s consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . This guidance is intended to simplify the accounting for certain financial instruments with characteristics of liabilities and equity. This standard is effective for annual reporting periods beginning after December 15, 2021, including interim reporting periods within those annual reporting periods. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company adopted this ASU during the year ended December 31, 2021. The adoption of this new accounting guidance did not have a material impact on the Company’s consolidated financial statements. |
Organization and Significant _3
Organization and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment | Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives as follows: Computer and office equipment 3 years Furniture and fixtures 5-7 years Laboratory equipment 7 years Property and equipment consisted of the following: December 31, 2021 2020 Computer equipment $ 58 $ 67 Furniture and fixtures 23 34 Laboratory equipment 4,134 2,930 Office equipment 177 72 Leasehold improvements 9,391 562 Property and equipment, gross 13,783 3,665 Less: Accumulated depreciation and amortization (1,582) (1,259) Total property and equipment, net $ 12,201 $ 2,406 |
Summary of Anti-dilutive Securities Excluded from Calculation of Weighted Average Common Shares Outstanding | The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average common shares outstanding for the years ended December 31, 2021 and 2020 because the effect is anti-dilutive due to the net loss reported in each of those periods. All share amounts presented in the table below represent the total number outstanding as of the end of each period. December 31, 2021 2020 Warrants to purchase common stock (Note 10) 1,274,176 1,377,727 Stock options outstanding under the 2008 and 2016 Plans (Note 11) 517,303 190,449 Stock appreciation rights outstanding under the 2016 Plan (Note 11) 60,000 61,000 Inducement stock options outstanding (Note 11) 1,250 8,750 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Contract Assets and Contract Liabilities | The following table presents the Company’s contract assets and contract liabilities balances for the periods indicated. Contract Asset Contract Liability Net Deferred Revenue December 31, 2020 $ 4,843 $ 16,071 $ 11,228 December 31, 2021 $ — $ 13,251 $ 13,251 Short-term Deferred Revenue Long-term Deferred Revenue Net Deferred Revenue December 31, 2020 $ 2,990 $ 8,238 $ 11,228 December 31, 2021 $ 2,586 $ 10,665 $ 13,251 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives as follows: Computer and office equipment 3 years Furniture and fixtures 5-7 years Laboratory equipment 7 years Property and equipment consisted of the following: December 31, 2021 2020 Computer equipment $ 58 $ 67 Furniture and fixtures 23 34 Laboratory equipment 4,134 2,930 Office equipment 177 72 Leasehold improvements 9,391 562 Property and equipment, gross 13,783 3,665 Less: Accumulated depreciation and amortization (1,582) (1,259) Total property and equipment, net $ 12,201 $ 2,406 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments | Future minimum lease payments, net of amounts expected to be received related to the tenant improvement allowance, as of December 31, 2021 were as follows: Maturity of Lease Liabilities Operating Lease 2022 $ (448) 2023 608 2024 626 2025 645 2026 665 2027 and beyond 3,700 Total future undiscounted lease payments $ 5,796 Add: reclassification of discounted net cash inflows to other current assets $ 109 Less: imputed interest $ (2,292) Total reported lease liability $ 3,613 |
Components of Lease Assets and Liabilities | Components of lease assets and liabilities as of December 31, 2021 were as follows: As of December 31, 2021 Leases Assets Other current asset related to leasing arrangement, net $ 109 Right-of-use lease assets 1,693 Total assets $ 1,802 Liabilities Noncurrent operating lease liabilities $ 3,613 Total lease liabilities $ 3,613 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Reserved Shares of Common Stock for Future Issuance | The following table presents the Company’s outstanding warrants to purchase common stock for the periods indicated. December 31, Exercise 2021 2020 Warrants to purchase common stock issued in the January 2018 Offering 999,850 1,000,000 $ 46.60 Warrants to purchase common stock issued in the March 2020 Public Offering 252,417 262,417 3.00 Underwriter warrants to purchase common stock associated with the March 2020 Public Offering 11,304 59,496 3.75 Placement agent warrants to purchase common stock issued in the March 2020 Registered Direct Offering 10,605 55,814 5.375 1,274,176 1,377,727 The Company had reserved shares of common stock for future issuance as follows: December 31, 2021 2020 Outstanding warrants to purchase common stock 1,274,176 1,377,727 Outstanding stock options (Note 11) 518,553 199,199 Outstanding stock appreciation rights (Note 11) 60,000 61,000 For possible future issuance under the 2016 Stock Plan (Note 11) 1,213,224 52,378 3,065,953 1,690,304 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of share-based compensation expenses | During the years ended December 31, 2021 and 2020, the Company recorded employee stock-based compensation expense, including fair value adjustments of the Tangible Stockholder Return Plan, as follows: Year Ended December 31, 2021 2020 Stock options $ 826 $ 840 Stock appreciation rights 115 151 Tangible Stockholder Return Plan (Note 12) (666) 317 Total $ 275 $ 1,308 Total stock-based compensation expense for the years ended December 31, 2021 and 2020 included in the accompanying consolidated statements of operations and comprehensive loss is as follows: Year Ended December 31, 2021 2020 Research and development $ (250) $ 834 General and administrative 525 474 Total $ 275 $ 1,308 |
Schedule of fair value assumptions | The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, and the following weighted average assumptions: Year Ended December 31, 2021 2020 Estimated dividend yield — % — % Expected volatility 107.54 % 105.64 % Risk-free interest rate 1.02 % 1.10 % Expected life of options (in years) 5.79 5.46 Weighted-average fair value per share $ 7.13 $ 4.11 The fair value of the Performance Plan is estimated at each financial reporting date using the Monte Carlo simulation model and the following assumptions: December 31, 2021 2020 Estimated dividend yield — — Expected volatility 125.72 % 200.00 % Risk-free interest rate 0.07 % 0.11 % Expected term (years) 0.17 1.17 Fair value per share of common stock underlying the Performance Plan $ 4.26 $ 8.70 |
Summary of stock option activity | Stock option activity for the periods indicated is as follows: Shares Shares Weighted- Weighted- Aggregate Options outstanding as of December 31, 2019 38,844 178,933 $ 38.90 SARs granted (61,000) — SARs forfeited 100,000 — Options granted (55,700) 55,700 5.21 Options forfeited 30,234 (34,284) 32.89 Options exercised — (1,150) 4.65 Options outstanding as of December 31, 2020 52,378 199,199 $ 30.71 Additional shares reserved under plan 1,500,000 — SARs granted — — SARs forfeited 1,000 — Options granted (385,885) 385,885 8.82 Options forfeited 45,731 (53,689) 26.72 Options exercised — (12,842) 4.74 Options outstanding as of December 31, 2021 1,213,224 518,553 $ 15.48 8.76 $ 2 Vested and expected to vest as of 198,377 $ 30.75 7.64 $ 147 Exercisable as of December 31, 2020 178,287 $ 32.56 7.53 $ 141 Vested and expected to vest as of 470,773 $ 16.24 8.67 $ 2 Exercisable as of December 31, 2021 200,638 $ 26.59 7.46 $ 2 |
Tangible Stockholder Return P_2
Tangible Stockholder Return Plan (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Fair Value of Performance Plans Assumptions | The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, and the following weighted average assumptions: Year Ended December 31, 2021 2020 Estimated dividend yield — % — % Expected volatility 107.54 % 105.64 % Risk-free interest rate 1.02 % 1.10 % Expected life of options (in years) 5.79 5.46 Weighted-average fair value per share $ 7.13 $ 4.11 The fair value of the Performance Plan is estimated at each financial reporting date using the Monte Carlo simulation model and the following assumptions: December 31, 2021 2020 Estimated dividend yield — — Expected volatility 125.72 % 200.00 % Risk-free interest rate 0.07 % 0.11 % Expected term (years) 0.17 1.17 Fair value per share of common stock underlying the Performance Plan $ 4.26 $ 8.70 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Federal Income Tax Rate to Losses Before Income Tax Benefit | The reasons for the difference between actual income tax benefit for the years ended December 31, 2021 and 2020, and the amount computed by applying the statutory federal income tax rate to losses before income tax benefit are as follows: Year Ended December 31, 2021 2020 Income tax benefit at federal statutory rate $ (6,235) $ (6,152) State income taxes, net of federal benefit — (533) Non-deductible expenses 63 492 Research and development tax credits (768) (885) Write-off of Attributes Due to Sections 382 and 383 — 34,983 Change in State Tax Rate 1,532 — Other (96) 222 Change in valuation allowance 5,504 (28,127) Total income tax provision $ — $ — |
Significant Components of Company's Deferred Tax Assets and Deferred Tax Liabilities | Significant components of the Company’s deferred tax assets and deferred tax liabilities are as follows: As of December 31, 2021 2020 Deferred tax assets: Accrued compensation $ 247 $ 214 Accrued liabilities 117 375 Tax loss carryforwards 21,008 16,186 Intangible assets 213 248 Stock-based compensation 499 526 Tax credits 1,653 885 Research and development service obligation 5,575 6,120 Right-of-use lease liabilities 736 — Deferred revenue 1,849 1,649 Fixed assets 305 345 Other 50 52 Total deferred tax assets 32,252 26,600 Less valuation allowance (31,808) (26,304) Net deferred tax asset 444 296 Deferred tax liabilities: Right-of-use lease assets (356) — Other (88) (296) Net noncurrent deferred tax asset (liability) $ — $ — |
Asset Group Disposition (Tables
Asset Group Disposition (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Loss on Facility Asset Group Disposition | The following table summarizes the loss on facility asset group disposition as presented within the accompanying consolidated statements of operations and comprehensive loss during the year ended December 31, 2020: Property and Equipment, net $ 4,902 Restricted cash (security deposit) 539 Right-of-use assets 1,816 Total facility group assets 7,257 Lease liabilities, current portion (1,169) Lease liabilities, net of current portion (4,782) Total facility group liabilities (5,951) Net carrying value of facility asset group $ 1,306 Other direct disposal costs 466 Loss on facility asset group disposition $ 1,772 |
Organization and Significant _4
Organization and Significant Accounting Policies - Additional Information (Details) | Jun. 17, 2021USD ($) | May 25, 2021shares | Dec. 31, 2020USD ($)shares | Jul. 21, 2020USD ($) | Jul. 16, 2020USD ($) | Dec. 31, 2021USD ($)segmentshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2021USD ($)shares |
Organization And Significant Accounting Policies [Line Items] | ||||||||
Stock split, conversion ratio | 0.1 | |||||||
Fractional shares issued, reverse stock split (in shares) | shares | 0 | |||||||
Accumulated deficit | $ (249,277,000) | $ (278,969,000) | $ (249,277,000) | $ (278,969,000) | ||||
Cash and cash equivalents | $ 35,879,000 | 47,085,000 | 35,879,000 | $ 47,085,000 | ||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | 37,600,000 | 12,577,000 | ||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ 6,334,000 | $ 33,941,000 | ||||||
Common stock, shares outstanding (in shares) | shares | 15,170,678 | 14,570,009 | 18,815,892 | 14,570,009 | 18,815,892 | |||
Common stock shares reserved for future issuance (in shares) | shares | 1,690,304 | 3,065,953 | 1,690,304 | 3,065,953 | ||||
Common stock, shares authorized (in shares) | shares | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | ||||
Reclassification of prepaid expenses and other current assets | $ 58,000 | |||||||
Common stock issued | 1,000 | $ 2,000 | $ 1,000 | $ 2,000 | ||||
Additional paid-in-capital | 252,408,000 | 297,441,000 | 252,408,000 | 297,441,000 | ||||
Accrued interest or penalties related to uncertain tax positions | 0 | $ 0 | 0 | 0 | ||||
Number of operating segments (in segments) | segment | 1 | |||||||
Revision of prior period, reclassification adjustment | ||||||||
Organization And Significant Accounting Policies [Line Items] | ||||||||
Common stock issued | 13,000 | 13,000 | ||||||
Additional paid-in-capital | $ 13,000 | 13,000 | ||||||
Primary Facility Lease | ||||||||
Organization And Significant Accounting Policies [Line Items] | ||||||||
Security deposit forfeited | $ 539,000 | |||||||
Amended Sato Agreement | ||||||||
Organization And Significant Accounting Policies [Line Items] | ||||||||
Revenue | $ 2,822,000 | $ 4,208,000 | ||||||
Percentage of total revenue generated from Japan licensing partner | 95.00% | 86.00% | ||||||
June 2021 Public Offering | ||||||||
Organization And Significant Accounting Policies [Line Items] | ||||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ 37,236,000 | |||||||
Underwriting discounts and commissions and offering expenses | $ 2,764,000 | |||||||
Aspire Capital | July 2020 Common Stock Purchase Agreement | ||||||||
Organization And Significant Accounting Policies [Line Items] | ||||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ 5,000,000 | $ 6,334,000 | 17,995,000 | |||||
Available for sale under common stock purchase agreement | $ 12,005,000 | $ 12,005,000 |
Organization and Significant _5
Organization and Significant Accounting Policies - Schedule of Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Computer and office equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful life | 3 years |
Furniture and fixtures | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful life | 5 years |
Furniture and fixtures | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful life | 7 years |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful life | 7 years |
Organization and Significant _6
Organization and Significant Accounting Policies - Summary of Anti-dilutive Securities Excluded from Calculation of Weighted Average Common Shares Outstanding (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 1,274,176 | 1,377,727 |
Stock options | 2008 and 2016 Plans | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 517,303 | 190,449 |
Stock options | Inducement Options Outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 1,250 | 8,750 |
Stock Appreciation Rights (SARs) | 2016 Stock Plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 60,000 | 61,000 |
KNOW Bio, LLC (Details)
KNOW Bio, LLC (Details) - USD ($) | Oct. 13, 2017 | Dec. 29, 2015 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 30, 2015 |
Collaborative Arrangements Transactions [Line Items] | |||||
Milestone and royalty payments | $ 0 | $ 0 | |||
KNOW Bio | |||||
Collaborative Arrangements Transactions [Line Items] | |||||
Percentage of outstanding member interests of KNOW Bio distributed to stockholders | 100.00% | ||||
Written notice to terminate, period | 90 days | ||||
Option term for development and commercialization of products rights | 3 years | ||||
Upfront license agreement payment due upon execution | $ 250,000 |
Research and Development Lice_2
Research and Development Licenses (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Jun. 27, 2012 | |
Research And Development Licenses [Line Items] | |||
Research and development expense | $ 20,416,000 | $ 19,814,000 | |
General and administrative expense | 12,343,000 | 11,271,000 | |
Licensing Agreements | |||
Research And Development Licenses [Line Items] | |||
Research and development expense | 0 | 0 | |
General and administrative expense | 137,000 | $ 103,000 | |
Accrual for future payments | $ 0 | ||
UNC License Agreement | |||
Research And Development Licenses [Line Items] | |||
Potential regulatory and commercial milestones payable under agreement | $ 425,000 |
Licensing Arrangements (Details
Licensing Arrangements (Details) - Amended Sato Agreement | Nov. 07, 2019JPY (¥) | Nov. 07, 2019USD ($) | Mar. 14, 2019JPY (¥) | Mar. 14, 2019USD ($) | Oct. 23, 2018JPY (¥) | Oct. 23, 2018USD ($) | Oct. 05, 2018USD ($) | Jan. 19, 2017JPY (¥) | Jan. 19, 2017USD ($) | May 20, 2021JPY (¥) | May 20, 2021USD ($) | Sep. 13, 2019JPY (¥) | Feb. 14, 2019JPY (¥) | Dec. 31, 2018JPY (¥) | Dec. 31, 2018USD ($) | Oct. 05, 2018JPY (¥) | Jan. 12, 2017JPY (¥) | Jan. 12, 2017USD ($) |
Collaborative Arrangements Transactions [Line Items] | ||||||||||||||||||
Upfront payment receivable | ¥ 1,250,000,000 | |||||||||||||||||
Upfront payment installments | ¥ 500,000,000 | ¥ 500,000,000 | 250,000,000 | |||||||||||||||
Payment received under license agreement | ¥ 500,000,000 | $ 4,554,000 | ¥ 500,000,000 | $ 4,460,000 | ¥ 250,000,000 | $ 2,224,000 | ¥ 1,250,000,000 | $ 10,813,000 | ||||||||||
Aggregate development and regulatory milestone payments potentially receivable under license agreement | 1,750,000,000 | ¥ 2,750,000,000 | ||||||||||||||||
Milestone payment received following initiation of Phase 1 trial | ¥ 250,000,000 | $ 2,162,000 | 250,000,000 | $ 2,162,000 | ||||||||||||||
Aggregate becoming payable upon earlier of specified future dates or achievement of milestone events | 1,000,000,000 | |||||||||||||||||
Non contingent milestone payment received under license agreement | ¥ 500,000,000 | $ 4,572,000 | ||||||||||||||||
Aggregate commercial milestone payments potentially receivable under license agreement | ¥ 3,900,000,000 | ¥ 900,000,000 | ||||||||||||||||
License agreement additional term | 2 years | |||||||||||||||||
Maximum preclinical studies amount | $ | $ 1,000,000 | |||||||||||||||||
Written notice to terminate, period | 120 days | |||||||||||||||||
Written notice to terminate due to material breach, term | 60 days | |||||||||||||||||
Upfront fee refundable in event of termination | $ | $ 0 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Details) | Nov. 07, 2019USD ($) | Nov. 07, 2019JPY (¥) | Mar. 14, 2019USD ($) | Mar. 14, 2019JPY (¥) | Oct. 23, 2018USD ($) | Oct. 23, 2018JPY (¥) | Oct. 05, 2018USD ($) | Jan. 19, 2017USD ($) | Jan. 19, 2017JPY (¥) | Jul. 31, 2021USD ($) | Nov. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | May 20, 2021USD ($) | May 20, 2021JPY (¥) | Feb. 29, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 13, 2019JPY (¥) | Aug. 30, 2019USD ($) | Feb. 14, 2019JPY (¥) | Dec. 31, 2018USD ($) | Dec. 31, 2018JPY (¥) | Oct. 05, 2018JPY (¥) | Jan. 12, 2017USD ($) | Jan. 12, 2017JPY (¥) |
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Consideration subject to unconditional right to receive | $ 4,345,000 | |||||||||||||||||||||||||
Extension of estimated performance period | 9 months | 1 year 9 months | ||||||||||||||||||||||||
Estimated performance period | 10 years | 9 years 3 months | 7 years 6 months | |||||||||||||||||||||||
Percentage used in case study | 0.12 | |||||||||||||||||||||||||
Performance obligations under long-term contracts unsatisfied | 13,251,000 | |||||||||||||||||||||||||
License and collaboration revenue | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Revenue | 2,822,000 | $ 4,208,000 | ||||||||||||||||||||||||
Adjustment to revenue, change in measure of progress | $ (34,000) | |||||||||||||||||||||||||
Government research contracts and grants revenue | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Government research contracts and grants revenue | 136,000 | 712,000 | ||||||||||||||||||||||||
National Institutes of Health | Government research contracts and grants revenue | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Amount awarded from government grant | $ 997,000 | $ 223,000 | ||||||||||||||||||||||||
Government research contracts and grants revenue | 126,000 | 168,000 | ||||||||||||||||||||||||
National Institutes of Health | Phase 1 Grant | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Government research contracts and grants revenue | 0 | 29,000 | ||||||||||||||||||||||||
U.S. Department of Defense | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Amount awarded from government grant | $ 1,113,000 | |||||||||||||||||||||||||
U.S. Department of Defense | Government research contracts and grants revenue | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Government research contracts and grants revenue | 10,000 | 515,000 | ||||||||||||||||||||||||
Amended Sato Agreement | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Maximum preclinical studies amount | $ 1,000,000 | |||||||||||||||||||||||||
Payment received under license agreement | $ 4,554,000 | ¥ 500,000,000 | $ 4,460,000 | ¥ 500,000,000 | $ 2,224,000 | ¥ 250,000,000 | $ 10,813,000 | ¥ 1,250,000,000 | ||||||||||||||||||
Milestone payment received following initiation of Phase 1 trial | $ 2,162,000 | ¥ 250,000,000 | $ 2,162,000 | ¥ 250,000,000 | ||||||||||||||||||||||
Upfront payment receivable | ¥ | ¥ 1,250,000,000 | |||||||||||||||||||||||||
Upfront payment installments | ¥ | ¥ 500,000,000 | ¥ 500,000,000 | 250,000,000 | |||||||||||||||||||||||
Aggregate becoming payable upon earlier of specified future dates or achievement of milestone events | ¥ | 1,000,000,000 | |||||||||||||||||||||||||
Revenue | 2,822,000 | 4,208,000 | ||||||||||||||||||||||||
Fees paid to third party | 115,000 | 0 | ||||||||||||||||||||||||
Aggregate commercial milestone payments potentially receivable under license agreement | ¥ | ¥ 3,900,000,000 | ¥ 900,000,000 | ||||||||||||||||||||||||
Non contingent milestone payment received under license agreement | $ 4,572,000 | ¥ 500,000,000 | ||||||||||||||||||||||||
Amended Sato Agreement | Other nonoperating income (expense) | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Foreign currency adjustment | 500,000 | |||||||||||||||||||||||||
Amended Sato Agreement | License and collaboration revenue | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Revenue | 2,822,000 | $ 4,208,000 | ||||||||||||||||||||||||
Amended Sato Agreement | Accrued expenses | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Capitalized contract acquisition costs | 109,000 | |||||||||||||||||||||||||
Amended Sato Agreement | Prepaid expenses and other current assets | ||||||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||||||
Capitalized contract acquisition costs | $ 345,000 |
Revenue Recognition - Contract
Revenue Recognition - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenue from Contract with Customer [Abstract] | ||
Contract asset | $ 0 | $ 4,843 |
Contract liability, gross | 13,251 | 16,071 |
Net deferred revenue | 13,251 | 11,228 |
Deferred revenue, current portion | 2,586 | 2,990 |
Deferred revenue, net of current portion | $ 10,665 | $ 8,238 |
Revenue Recognition - Performan
Revenue Recognition - Performance Obligations, Expected Timing of Satisfaction (Details) - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-01-01 | Dec. 31, 2021 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Estimated performance period | 12 months |
Revenue remaining performance obligation percentage | 20.00% |
Research and Development Arra_2
Research and Development Arrangements (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | May 04, 2019 | Apr. 29, 2019 | |
Ligand Pharmaceuticals Incorporated | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Immediate funding | $ 12,000,000 | |||
Potential regulatory and commercial milestones payable under agreement | $ 20,000,000 | |||
Minimum | Ligand Pharmaceuticals Incorporated | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Tiered royalties, percentage | 7.00% | |||
Maximum | Ligand Pharmaceuticals Incorporated | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Tiered royalties, percentage | 10.00% | |||
SB206 | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Restricted cash related to Funding Agreement | $ 0 | $ 0 | ||
SB206 | Ligand Pharmaceuticals Incorporated | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Research and development contra expense | $ (88,000) | $ (2,179,000) | ||
Restricted Cash | SB206 | Ligand Pharmaceuticals Incorporated | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Immediate funding | $ 12,000,000 | |||
Reedy Creek Investments LLC | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Immediate funding | $ 25,000,000 | |||
Initial percentage of fees and milestone to determine quarterly payments per agreement | 25.00% | |||
Reedy Creek Investments LLC | Novan, Inc. | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Percentage ownership of common stock outstanding | 5.00% | |||
Reedy Creek Investments LLC | SB206 | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Percentage used to determine ongoing quarterly payments per agreement | 10.00% | |||
Reedy Creek Investments LLC | SB204 And SB414 | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Percentage used to determine ongoing quarterly payments per agreement | 20.00% | |||
Reedy Creek Investments LLC | Cash and Cash Equivalents | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Immediate funding | $ 25,000,000 |
Property and Equipment, Net - C
Property and Equipment, Net - Components of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 13,783 | $ 3,665 |
Less: Accumulated depreciation and amortization | (1,582) | (1,259) |
Property and equipment, net | 12,201 | 2,406 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 58 | 67 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 23 | 34 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,134 | 2,930 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 177 | 72 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 9,391 | $ 562 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Long Lived Assets Held-for-sale [Line Items] | ||
Depreciation and amortization | $ 344 | $ 1,170 |
Leasehold improvements | ||
Long Lived Assets Held-for-sale [Line Items] | ||
Construction in progress | 7,485 | 562 |
Accounts payable | ||
Long Lived Assets Held-for-sale [Line Items] | ||
Construction in process payable | 451 | 17 |
Accrued expenses | ||
Long Lived Assets Held-for-sale [Line Items] | ||
Construction in process payable | $ 1,020 | $ 365 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Nov. 18, 2021USD ($) | Jan. 18, 2021USD ($)ft²$ / ft² | Jul. 16, 2020USD ($)ft² | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Nov. 23, 2021ft² | Sep. 01, 2020ft² | Jun. 30, 2020USD ($) | Aug. 31, 2015ft² |
Commitments And Contingencies [Line Items] | |||||||||
Square footage of leased space (in square feet) | ft² | 51,000 | ||||||||
Optional term of extending lease agreement | 5 years | ||||||||
Remaining minimum lease payments under Primary Facility Lease | $ 5,796,000 | ||||||||
Rent expense | 467,000 | $ 550,000 | |||||||
Short-term rent expense | $ 539,000 | 266,000 | |||||||
Weighted average remaining lease term, operating leases | 10 years 2 months 1 day | ||||||||
Weighted average discount rate, operating lease liabilities | 8.35% | ||||||||
Tenant Improvements | $ 2,450,000 | ||||||||
Proceeds from tenant improvement allowance | (1,523,000) | ||||||||
Other current asset related to leasing arrangement, net | 109,000 | 0 | |||||||
Accrued technical transfer capabilities and production costs | $ 1,072,000 | 0 | |||||||
Primary Facility Lease | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Square footage of leased space (in square feet) | ft² | 12,000 | 10,000 | |||||||
Remaining minimum lease payments under Primary Facility Lease | $ 7,900,000 | ||||||||
Lease termination fee | $ 600,000 | ||||||||
Security deposit forfeited | 539,000 | ||||||||
Cash paid for lease termination fee | 61,000 | ||||||||
Real estate broker fee | 405,000 | ||||||||
Costs directly associated with execution of lease termination agreement | $ 1,005,000 | ||||||||
Primary Facility Lease | Research and development | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Facility decommissioning and environmental remediation costs | $ 300,000 | ||||||||
New corporate headquarters | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Square footage of leased space (in square feet) | ft² | 19,265 | 15,623 | |||||||
Optional term of extending lease agreement | 5 years | ||||||||
Additional square footage of lease space (in square feet) | ft² | 3,642 | ||||||||
Monthly base rent | $ 49,000 | $ 40,000 | |||||||
Monthly base rent increase | 3.00% | ||||||||
Rent abatement period | 3 months | ||||||||
New corporate headquarters | Letter of credit | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Letter of credit | $ 583,000 | ||||||||
First amendment | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Tenant improvement allowance (in dollars per square foot) | $ / ft² | 130 | ||||||||
Tenant improvement allowance | 2,031,000 | ||||||||
Second amendment | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Tenant improvement allowance (in dollars per square foot) | $ / ft² | 115 | ||||||||
Tenant improvement allowance | $ / ft² | 419,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 | $ (448) |
2023 | 608 |
2024 | 626 |
2025 | 645 |
2026 | 665 |
Thereafter | 3,700 |
Total future undiscounted lease payments | 5,796 |
Add: reclassification of discounted net cash inflows to other current assets | 109 |
Less: imputed interest | (2,292) |
Total reported lease liability | $ 3,613 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of Lease Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets | ||
Other current asset related to leasing arrangement, net | $ 109 | $ 0 |
Right-of-use lease assets | 1,693 | 0 |
Total assets | 1,802 | |
Liabilities | ||
Noncurrent operating lease liabilities | 3,613 | $ 0 |
Total lease liabilities | $ 3,613 |
Paycheck Protection Program (De
Paycheck Protection Program (Details) - Paycheck Protection Program Loan $ in Thousands | Apr. 22, 2020USD ($) |
Debt Instrument [Line Items] | |
Unsecured loan made under Paycheck Protection Program | $ 956 |
Fixed interest rate of loan per annum | 1.00% |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Additional Information (Details) | Jun. 17, 2021USD ($)$ / sharesshares | May 25, 2021shares | Jul. 28, 2020 | Jul. 21, 2020USD ($)$ / sharesshares | Jun. 15, 2020USD ($)$ / sharesshares | Mar. 26, 2020USD ($)$ / sharesshares | Mar. 03, 2020USD ($)$ / sharesshares | Aug. 30, 2019USD ($)$ / sharesshares | Jan. 09, 2018USD ($)$ / sharesshares | Jul. 31, 2020USD ($) | Jun. 30, 2020USD ($)shares | Aug. 31, 2019USD ($) | Apr. 30, 2016USD ($)shares | Dec. 31, 2020USD ($)$ / sharesshares | Jun. 15, 2020USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Jun. 14, 2020$ / shares | Sep. 16, 2019shares | Aug. 29, 2019$ / shares |
Class of Stock [Line Items] | ||||||||||||||||||||||
Capital stock, shares authorized (in shares) | 210,000,000 | 210,000,000 | ||||||||||||||||||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | |||||||||||||||||
Common stock, par value (in USD per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||||||||||
Preferred stock, par value (in USD per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||
Stock split, conversion ratio | 0.1 | |||||||||||||||||||||
Reverse stock split, conversion ratio | 10 | |||||||||||||||||||||
Common stock, shares outstanding (in shares) | 15,170,678 | 14,570,009 | 18,815,892 | 14,570,009 | 14,570,009 | 18,815,892 | ||||||||||||||||
Common stock, shares issued (in shares) | 15,170,678 | 14,570,959 | 18,816,842 | 14,570,959 | 14,570,959 | 18,816,842 | ||||||||||||||||
Common stock issued during period (in shares) | 3,636,364 | 1,055,000 | 1,400,000 | |||||||||||||||||||
Period of option to purchase additional shares | 30 days | 30 days | ||||||||||||||||||||
Common stock, maximum additional shares available for purchase (in shares) | 545,454 | 275,000 | ||||||||||||||||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ | $ 37,600,000 | $ 12,577,000 | ||||||||||||||||||||
Maximum additional number of common warrants available for purchase (in shares) | 275,000 | |||||||||||||||||||||
Percentage of common stock sold related to warrants issued | 3.00% | 3.00% | ||||||||||||||||||||
Fundamental transaction common stock acquired threshold | 50.00% | |||||||||||||||||||||
Black Scholes valuation input, historical volatility period | 100 days | |||||||||||||||||||||
Maximum volatility rate used to derive Black-Scholes Value in event of fundamental transaction | 100.00% | |||||||||||||||||||||
Warrant exercise limitation, maximum beneficial ownership percentage, current | 4.99% | |||||||||||||||||||||
Warrant exercise limitation, maximum beneficial ownership percentage, if elected by holder | 9.99% | |||||||||||||||||||||
Beneficial ownership percentage providing for exercise limitation exception | 10.00% | |||||||||||||||||||||
Proceeds from exercise of common stock warrants | $ | 461,000 | 5,538,000 | ||||||||||||||||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ | $ 6,334,000 | $ 33,941,000 | ||||||||||||||||||||
Treasury stock acquired (in shares) | 950 | |||||||||||||||||||||
Treasury stock acquired | $ | $ 155,000 | |||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | |||||||||||||||||
June 2021 Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ | $ 37,236,000 | |||||||||||||||||||||
Underwriting discounts and commissions and offering expenses | $ | $ 2,764,000 | |||||||||||||||||||||
March 2020 Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ | $ 5,158,000 | |||||||||||||||||||||
Underwriting discounts and commissions and offering expenses | $ | $ 791,000 | |||||||||||||||||||||
Registered Direct Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ | $ 7,225,000 | |||||||||||||||||||||
Underwriting discounts and commissions and offering expenses | $ | $ 774,000 | |||||||||||||||||||||
January 2018 Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Common stock issued during period (in shares) | 1,000,000 | |||||||||||||||||||||
Price per share (in USD per share) | $ / shares | $ 38 | |||||||||||||||||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ | $ 35,194,000 | |||||||||||||||||||||
Underwriting discounts and commissions and offering expenses | $ | $ 2,806,000 | |||||||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 46.60 | |||||||||||||||||||||
Warrants expiration period | 4 years | |||||||||||||||||||||
Warrants exercised during period (in shares) | 150 | 0 | ||||||||||||||||||||
July 2020 Common Stock Purchase Agreement | Aspire Capital | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Maximum value of shares of common stock authorized to be sold | $ | $ 30,000,000 | |||||||||||||||||||||
Common stock purchase agreement term | 30 months | |||||||||||||||||||||
Number of shares sold (in shares) | 555,555 | 2,221,040 | ||||||||||||||||||||
Closing sale price of common stock (in usd per share) | $ / shares | $ 9 | |||||||||||||||||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ | $ 5,000,000 | $ 6,334,000 | $ 17,995,000 | |||||||||||||||||||
Shares of common stock issued for commitment fee (in shares) | 100,000 | |||||||||||||||||||||
Value of commitment fee shares issued | $ | $ 847,000 | |||||||||||||||||||||
Maximum shares to be purchased with purchase notice per business day (in shares) | 30,000 | |||||||||||||||||||||
Purchase price covenant, consecutive trading days | 10 days | |||||||||||||||||||||
Maximum aggregate purchase price payable on one purchase date | $ | $ 500,000 | |||||||||||||||||||||
Maximum shares to be purchased per trading day upon mutual agreement (in shares) | 200,000 | |||||||||||||||||||||
Number of shares submitted via purchase notice to trigger a VWAP purchase notice (in shares) | 30,000 | |||||||||||||||||||||
Maximum percentage of common stock traded on trading day to be purchased | 30.00% | |||||||||||||||||||||
Purchase price per share pursuant to VWAP purchase notice as a percentage of VWAP for common stock | 97.00% | |||||||||||||||||||||
Minimum closing sale price to effect purchase of shares (in usd per share) | $ / shares | $ 0.15 | |||||||||||||||||||||
Maximum number of shares that may be sold under agreement (in shares) | 2,543,364 | |||||||||||||||||||||
Percentage of common stock on date of purchase agreement that cannot be exceeded | 19.99% | |||||||||||||||||||||
Minimum average price per share paid for all shares issued to allow for additional share issuance (in usd per share) | $ / shares | $ 5.907 | |||||||||||||||||||||
Average sales price per share of common stock (in usd per share) | $ / shares | $ 8.10 | |||||||||||||||||||||
Available for sale under common stock purchase agreement | $ | $ 12,005,000 | $ 12,005,000 | ||||||||||||||||||||
June 2020 Common Stock Purchase Agreement | Aspire Capital | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Maximum value of shares of common stock authorized to be sold | $ | $ 20,000,000 | $ 20,000,000 | ||||||||||||||||||||
Common stock purchase agreement term | 30 months | |||||||||||||||||||||
Number of shares sold (in shares) | 3,776,428 | |||||||||||||||||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ | $ 20,000,000 | |||||||||||||||||||||
Shares of common stock issued for commitment fee (in shares) | 144,927 | |||||||||||||||||||||
Value of commitment fee shares issued | $ | $ 848,000 | |||||||||||||||||||||
Maximum shares to be purchased with purchase notice per business day (in shares) | 30,000 | 30,000 | ||||||||||||||||||||
Purchase price covenant, consecutive trading days | 10 days | |||||||||||||||||||||
Maximum aggregate purchase price payable on one purchase date | $ | $ 500,000 | $ 500,000 | ||||||||||||||||||||
Maximum shares to be purchased per trading day upon mutual agreement (in shares) | 200,000 | 200,000 | ||||||||||||||||||||
Number of shares submitted via purchase notice to trigger a VWAP purchase notice (in shares) | 30,000 | 30,000 | ||||||||||||||||||||
Maximum percentage of common stock traded on trading day to be purchased | 30.00% | 30.00% | ||||||||||||||||||||
Purchase price per share pursuant to VWAP purchase notice as a percentage of VWAP for common stock | 97.00% | 97.00% | ||||||||||||||||||||
Minimum closing sale price to effect purchase of shares (in usd per share) | $ / shares | $ 0.15 | $ 0.15 | ||||||||||||||||||||
Maximum number of shares that may be sold under agreement (in shares) | 1,585,949 | 1,585,949 | ||||||||||||||||||||
Percentage of common stock on date of purchase agreement that cannot be exceeded | 19.99% | 19.99% | ||||||||||||||||||||
Minimum average price per share paid for all shares issued to allow for additional share issuance (in usd per share) | $ / shares | $ 4.14 | |||||||||||||||||||||
Average sales price per share of common stock (in usd per share) | $ / shares | $ 5.30 | |||||||||||||||||||||
Available for sale under common stock purchase agreement | $ | $ 0 | $ 0 | $ 0 | |||||||||||||||||||
2019 Common Stock Purchase Agreement | Aspire Capital | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Common stock issued during period (in shares) | 521,133 | |||||||||||||||||||||
Maximum value of shares of common stock authorized to be sold | $ | $ 25,000,000 | |||||||||||||||||||||
Common stock purchase agreement term | 30 months | |||||||||||||||||||||
Number of shares sold (in shares) | 486,571 | |||||||||||||||||||||
Closing sale price of common stock (in usd per share) | $ / shares | $ 21.70 | |||||||||||||||||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ | $ 3,026,000 | |||||||||||||||||||||
Shares of common stock issued for commitment fee (in shares) | 34,562 | |||||||||||||||||||||
Value of commitment fee shares issued | $ | $ 750,000 | |||||||||||||||||||||
Maximum shares to be purchased with purchase notice per business day (in shares) | 10,000 | |||||||||||||||||||||
Purchase price covenant, consecutive trading days | 10 days | |||||||||||||||||||||
Maximum aggregate purchase price payable on one purchase date | $ | $ 500,000 | |||||||||||||||||||||
Number of shares submitted via purchase notice to trigger a VWAP purchase notice (in shares) | 10,000 | |||||||||||||||||||||
Maximum percentage of common stock traded on trading day to be purchased | 30.00% | |||||||||||||||||||||
Maximum number of shares that may be sold under agreement (in shares) | 521,134 | |||||||||||||||||||||
Percentage of common stock on date of purchase agreement that cannot be exceeded | 19.99% | |||||||||||||||||||||
Average sales price per share of common stock (in usd per share) | $ / shares | $ 6.22 | |||||||||||||||||||||
Available for sale under common stock purchase agreement | $ | $ 0 | 0 | $ 0 | |||||||||||||||||||
Common stock registered (in shares) | 703,263 | |||||||||||||||||||||
Percentage of share price pursuant to volume-weighted average stock price purchase notice | 97.00% | |||||||||||||||||||||
Minimum stock price to allow for purchases (in USD per share) | $ / shares | $ 0.25 | |||||||||||||||||||||
Period of prohibited issuance of additional securities in variable rate transactions | 1 year | |||||||||||||||||||||
Conditional period for VWAP to exceed purchase price per share to issue additional securities | 5 days | |||||||||||||||||||||
Common Stock Purchase Agreement | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ | $ 6,334,000 | 33,941,000 | ||||||||||||||||||||
Common stock issued during period | $ | 35,636,000 | |||||||||||||||||||||
Maximum | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Stock split, conversion ratio | 0.5 | |||||||||||||||||||||
Maximum | January 2018 Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants issued (in shares) | 1,000,000 | |||||||||||||||||||||
Minimum | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Stock split, conversion ratio | 0.067 | |||||||||||||||||||||
Pre Funded Warrant | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Price per share (in USD per share) | $ / shares | $ 4.299 | |||||||||||||||||||||
Warrants issued (in shares) | 805,465 | 433,333 | ||||||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 0.001 | |||||||||||||||||||||
Warrant exercise limitation, maximum beneficial ownership percentage, current | 4.99% | |||||||||||||||||||||
Warrant exercise limitation, maximum beneficial ownership percentage, if elected by holder | 9.99% | |||||||||||||||||||||
Pre Funded Warrant | March 2020 Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants owned (in shares) | 0 | |||||||||||||||||||||
Pre Funded Warrant | Registered Direct Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Common stock issued during period | $ | $ 7,225,000 | |||||||||||||||||||||
Common Warrant | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants issued (in shares) | 275,000 | |||||||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 3 | |||||||||||||||||||||
Warrants expiration period | 5 years | |||||||||||||||||||||
Warrants exercised during period (in shares) | 10,000 | 1,845,917 | ||||||||||||||||||||
Common Warrant | Maximum | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants issued (in shares) | 1,833,333 | |||||||||||||||||||||
Pre Funded and Common Stock Warrants | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Price per share (in USD per share) | $ / shares | $ 2.999 | |||||||||||||||||||||
Underwriter Warrant | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants issued (in shares) | 59,496 | |||||||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 3.75 | |||||||||||||||||||||
Warrants expiration period | 5 years | |||||||||||||||||||||
Warrants exercised during period (in shares) | 48,192 | 0 | ||||||||||||||||||||
Common and Underwriter Warrants | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Fundamental transaction common stock acquired threshold | 50.00% | |||||||||||||||||||||
Black Scholes valuation input, historical volatility period | 100 days | |||||||||||||||||||||
Maximum volatility rate used to derive Black-Scholes Value in event of fundamental transaction | 100.00% | |||||||||||||||||||||
Warrant exercise limitation, maximum beneficial ownership percentage, current | 4.99% | |||||||||||||||||||||
Warrant exercise limitation, maximum beneficial ownership percentage, if elected by holder | 9.99% | |||||||||||||||||||||
Placement Agent Warrant | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 5.375 | |||||||||||||||||||||
Warrants expiration period | 5 years | |||||||||||||||||||||
Warrants exercised during period (in shares) | 45,209 | 0 | ||||||||||||||||||||
Placement Agent Warrant | Maximum | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants issued (in shares) | 55,814 | |||||||||||||||||||||
Common Stock | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Common stock issued during period (in shares) | 149,860 | |||||||||||||||||||||
Price per share (in USD per share) | $ / shares | $ 11 | $ 4.30 | ||||||||||||||||||||
Common Stock | Common Stock Purchase Agreement | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Common stock issued during period (in shares) | 493,163 | 6,205,804 | ||||||||||||||||||||
Common stock issued during period | $ | $ 1,000 | |||||||||||||||||||||
Common Stock | Pre Funded Warrant | Registered Direct Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Common stock issued during period (in shares) | 1,055,000 | |||||||||||||||||||||
Common stock issued during period | $ | $ 1,000 | |||||||||||||||||||||
Common Stock | Common Warrant | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Price per share (in USD per share) | $ / shares | $ 3 | |||||||||||||||||||||
Warrants to purchase common stock | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants owned (in shares) | 1,377,727 | 1,274,176 | 1,377,727 | 1,377,727 | 1,274,176 | |||||||||||||||||
Weighted average exercise price of warrants (in dollars per share) | $ / shares | $ 34.77 | $ 37.24 | $ 34.77 | $ 34.77 | $ 37.24 | |||||||||||||||||
Warrants to purchase common stock | Common Warrant | March 2020 Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants owned (in shares) | 262,417 | 252,417 | 262,417 | 262,417 | 252,417 | |||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 3 | $ 3 | ||||||||||||||||||||
Warrants to purchase common stock | Common Warrant | January 2018 Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants owned (in shares) | 1,000,000 | 999,850 | 1,000,000 | 1,000,000 | 999,850 | |||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 46.60 | $ 46.60 | ||||||||||||||||||||
Warrants to purchase common stock | Underwriter Warrant | Registered Direct Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants owned (in shares) | 59,496 | 11,304 | 59,496 | 59,496 | 11,304 | |||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 3.75 | $ 3.75 | ||||||||||||||||||||
Warrants to purchase common stock | Placement Agent Warrant | Registered Direct Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants owned (in shares) | 55,814 | 10,605 | 55,814 | 55,814 | 10,605 | |||||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 5.375 | $ 5.375 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Schedule of Outstanding Warrants to Purchase Common Stock (Details) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 26, 2020 | Mar. 03, 2020 | Jan. 09, 2018 |
January 2018 Public Offering | |||||
Class of Stock [Line Items] | |||||
Warrant exercise price (in USD per share) | $ 46.60 | ||||
Warrants to purchase common stock | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 1,274,176 | 1,377,727 | |||
Common Warrant | |||||
Class of Stock [Line Items] | |||||
Warrant exercise price (in USD per share) | $ 3 | ||||
Common Warrant | Warrants to purchase common stock | January 2018 Public Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 999,850 | 1,000,000 | |||
Warrant exercise price (in USD per share) | $ 46.60 | ||||
Common Warrant | Warrants to purchase common stock | March 2020 Public Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 252,417 | 262,417 | |||
Warrant exercise price (in USD per share) | $ 3 | ||||
Underwriter Warrant | |||||
Class of Stock [Line Items] | |||||
Warrant exercise price (in USD per share) | $ 3.75 | ||||
Underwriter Warrant | Warrants to purchase common stock | Registered Direct Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 11,304 | 59,496 | |||
Warrant exercise price (in USD per share) | $ 3.75 | ||||
Placement Agent Warrant | |||||
Class of Stock [Line Items] | |||||
Warrant exercise price (in USD per share) | $ 5.375 | ||||
Placement Agent Warrant | Warrants to purchase common stock | Registered Direct Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 10,605 | 55,814 | |||
Warrant exercise price (in USD per share) | $ 5.375 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) - Schedule of Reserved Shares of Common Stock for Future Issuance (Details) - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 3,065,953 | 1,690,304 |
2016 Stock Plan | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 1,213,224 | 52,378 |
Warrants to purchase common stock | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 1,274,176 | 1,377,727 |
Outstanding stock options | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 518,553 | 199,199 |
Stock Appreciation Rights (SARs) | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 60,000 | 61,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | May 04, 2021 | Jan. 06, 2020 | Sep. 06, 2019 | Jul. 31, 2019 | Jul. 30, 2019 | May 31, 2018 | Jun. 05, 2017 | Sep. 20, 2016 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Additional awards to be granted under the plan (in shares) | 1,500,000 | ||||||||||
Shares available for future issuance (in shares) | 1,213,224 | 52,378 | 38,844 | ||||||||
Stock options expiration period | 10 years | ||||||||||
Stock-based compensation expense | $ 275 | $ 1,308 | |||||||||
Number of stock appreciation rights outstanding (in shares) | 60,000 | ||||||||||
Number of options granted to employees (in shares) | 385,885 | 55,700 | |||||||||
Stock options, exercise price at grant date (in USD per share) | $ 8.82 | $ 5.21 | |||||||||
Options forfeited (in shares) | 53,689 | 34,284 | |||||||||
Options outstanding (in shares) | 518,553 | 199,199 | 178,933 | ||||||||
Forfeiture estimate percentage | 11.90% | 12.20% | |||||||||
Total intrinsic value of options exercised | $ 97 | $ 3 | |||||||||
Total unrecognized compensation expense related to non-vested share based compensation | $ 1,852 | $ 140 | |||||||||
Weighted average period for nonvested share recognition | 2 years 3 months 3 days | 8 months 19 days | |||||||||
SARs | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Employment agreement, number of SARs granted on a contingent basis (in shares) | 60,000 | ||||||||||
Exercise price (in USD per share) | $ 8.20 | ||||||||||
Stock-based compensation expense | $ 115 | $ 151 | |||||||||
2008 Stock Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Additional awards to be granted under the plan (in shares) | 0 | ||||||||||
Stock options expiration period | 10 years | ||||||||||
2016 Stock Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Additional awards to be granted under the plan (in shares) | 1,500,000 | 100,000 | 120,000 | ||||||||
Common stock shares reserved for future issuance (in shares) | 83,333 | ||||||||||
Maximum aggregate shares to be awarded to one person (in shares) | 100,000 | 25,000 | |||||||||
Shares available for future issuance (in shares) | 1,213,224 | ||||||||||
Stock options expiration period | 10 years | ||||||||||
Inducement Grants | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Exercise price (in USD per share) | $ 26.20 | ||||||||||
Number of options granted to employees (in shares) | 2,500 | 10,050 | |||||||||
Stock options, exercise price at grant date (in USD per share) | $ 31.50 | ||||||||||
Stock options vesting period | 3 years | ||||||||||
Options outstanding (in shares) | 1,250 | ||||||||||
Inducement Grants | September 6, 2019 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Options forfeited (in shares) | 2,500 | ||||||||||
Inducement Grants | May 31, 2018 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Options forfeited (in shares) | 7,500 | 1,300 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of SAR Assumptions (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 275 | $ 1,308 |
Performance Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | (666) | 317 |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 826 | 840 |
SARs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 115 | $ 151 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Stock-based Compensation Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 275 | $ 1,308 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | (250) | 834 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 525 | $ 474 |
Share-Based Compensation - Fair
Share-Based Compensation - Fair Value of Option Grant Estimated on Grant Date Using Black-Scholes Option-pricing Model (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Estimated dividend yield | 0.00% | 0.00% |
Expected volatility | 107.54% | 105.64% |
Risk-free interest rate | 1.02% | 1.10% |
Expected life of options (in years) | 5 years 9 months 14 days | 5 years 5 months 15 days |
Weighted-average fair value per share (in USD per share) | $ 7.13 | $ 4.11 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Shares Available for Grant | ||
Options outstanding, beginning balance (in shares) | 52,378 | 38,844 |
SARs granted (in shares) | (61,000) | |
SARs forfeited (in shares) | 1,000 | 100,000 |
Options granted (in shares) | (385,885) | (55,700) |
Options forfeited (in shares) | 45,731 | 30,234 |
Additional shares reserved under plan (in shares) | 1,500,000 | |
Options outstanding, ending balance (in shares) | 1,213,224 | 52,378 |
Shares Subject to Outstanding Options | ||
Options outstanding, beginning balance (in shares) | 199,199 | 178,933 |
Options granted (in shares) | 385,885 | 55,700 |
Options forfeited (in shares) | (53,689) | (34,284) |
Options exercised (in shares) | (12,842) | (1,150) |
Options outstanding, ending balance (in shares) | 518,553 | 199,199 |
Vested and expected to vest (in shares) | 470,773 | 198,377 |
Exercisable (in shares) | 200,638 | 178,287 |
Weighted- Average Exercise Price Per Share | ||
Options outstanding, beginning balance (in USD per share) | $ 30.71 | $ 38.90 |
Options granted (in USD per share) | 8.82 | 5.21 |
Options forfeited (in USD per share) | 26.72 | 32.89 |
Options exercised (in USD per share) | 4.74 | 4.65 |
Options outstanding, ending balance (in USD per share) | 15.48 | 30.71 |
Vested and expected (in USD per share) | 16.24 | 30.75 |
Exercisable (in USD per share) | $ 26.59 | $ 32.56 |
Weighted- Average Remaining Contractual Term (in years) | ||
Options outstanding | 8 years 9 months 3 days | |
Vested and expected | 8 years 8 months 1 day | 7 years 7 months 20 days |
Exercisable | 7 years 5 months 15 days | 7 years 6 months 10 days |
Aggregate Intrinsic Value | ||
Options outstanding | $ 2 | |
Vested and expected to vest | 2 | $ 147 |
Exercisable | $ 2 | $ 141 |
Tangible Stockholder Return P_3
Tangible Stockholder Return Plan - Additional Information (Details) $ / shares in Units, $ in Thousands | May 25, 2021 | Aug. 02, 2018USD ($)tranche$ / shares | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock split, conversion ratio | 0.1 | |||
Estimated dividend yield | 0.00% | 0.00% | ||
Stock-based compensation expense | $ 275 | $ 1,308 | ||
Performance Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Estimated dividend yield | 0.00% | 0.00% | ||
Stock-based compensation expense | $ (666) | $ 317 | ||
Performance Plan | Deferred Bonus | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of tranches (in tranches) | tranche | 2 | |||
Number of consecutive trading days | 30 days | |||
Share price target, first tranche (in USD per share) | $ / shares | $ 111.70 | |||
Bonus pool, first tranche | $ 25,000 | |||
Share price target, second tranche (in USD per share) | $ / shares | $ 254.50 | |||
Bonus pool, second tranche | $ 50,000 | |||
Executive Officer | Performance Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Bonus award payment term | 24 months | |||
Employees And Consultants | Performance Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Bonus award payment term | 12 months |
Tangible Stockholder Return P_4
Tangible Stockholder Return Plan - Fair Value of Performance Plan Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Estimated dividend yield | 0.00% | 0.00% |
Expected volatility | 107.54% | 105.64% |
Risk-free interest rate | 1.02% | 1.10% |
Expected term (years) | 5 years 9 months 14 days | 5 years 5 months 15 days |
Performance Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Estimated dividend yield | 0.00% | 0.00% |
Expected volatility | 125.72% | 200.00% |
Risk-free interest rate | 0.07% | 0.11% |
Expected term (years) | 2 months 1 day | 1 year 2 months 1 day |
Fair value per share of common stock underlying the Performance Plan (in USD per share) | $ 4.26 | $ 8.70 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Apr. 22, 2020 | |
Operating Loss Carryforwards [Line Items] | |||
Income tax benefit | $ 0 | $ 0 | |
Tax loss carryforwards | 21,008,000 | 16,186,000 | |
Tax credit carryforward | 1,653,000 | 885,000 | |
Unrecognized tax benefits | 0 | 0 | |
Adjustments | |||
Operating Loss Carryforwards [Line Items] | |||
Tax loss carryforwards | (26,800,000) | ||
Tax credit carryforward | (9,700,000) | ||
Paycheck Protection Program Loan | |||
Operating Loss Carryforwards [Line Items] | |||
PPP loan amount | $ 956,000 | ||
Research tax credit carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward | 1,653,000 | ||
Prior year section 383 limitations | Adjustments | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward | (8,100,000) | ||
Current year section 383 limitations | Adjustments | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward | (1,600,000) | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 100,034,000 | ||
Federal | Adjustments | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | (113,800,000) | ||
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 62,907,000 | ||
State | Adjustments | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ (149,400,000) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Income Tax Rate to Losses Before Income Tax Benefit (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit at federal statutory rate | $ (6,235,000) | $ (6,152,000) |
State income taxes, net of federal benefit | 0 | (533,000) |
Non-deductible expenses | 63,000 | 492,000 |
Research and development tax credits | (768,000) | (885,000) |
Write-off of Attributes Due to Sections 382 and 383 | 0 | 34,983,000 |
Change in State Tax Rate | 1,532,000 | 0 |
Other | (96,000) | 222,000 |
Change in valuation allowance | 5,504,000 | (28,127,000) |
Total income tax provision | $ 0 | $ 0 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Company's Deferred Tax Assets and Deferred Tax Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Accrued compensation | $ 247 | $ 214 |
Accrued liabilities | 117 | 375 |
Tax loss carryforwards | 21,008 | 16,186 |
Intangible assets | 213 | 248 |
Stock-based compensation | 499 | 526 |
Tax credits | 1,653 | 885 |
Research and development service obligation | 5,575 | 6,120 |
Right-of-use lease liabilities | 736 | 0 |
Deferred revenue | 1,849 | 1,649 |
Fixed assets | 305 | 345 |
Other | 50 | 52 |
Total deferred tax assets | 32,252 | 26,600 |
Less valuation allowance | (31,808) | (26,304) |
Net deferred tax asset | 444 | 296 |
Deferred tax liabilities: | ||
Right-of-use lease assets | (356) | 0 |
Other | (88) | (296) |
Net noncurrent deferred tax asset (liability) | $ 0 | $ 0 |
Retirement Plan (Details)
Retirement Plan (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Employer contribution amount | $ 258 | $ 133 |
Maximum | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Discretionary matching contributions (as a percent) | 5.00% | 3.00% |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Thousands | Jun. 17, 2021 | Mar. 26, 2020 | Mar. 03, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | May 25, 2021 |
Related Party Transaction [Line Items] | |||||||
Common stock, number of shares held (in shares) | 18,815,892 | 14,570,009 | 15,170,678 | ||||
Common stock issued during period (in shares) | 3,636,364 | 1,055,000 | 1,400,000 | ||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ 37,600 | $ 12,577 | |||||
Common Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Common stock issued during period (in shares) | 149,860 | ||||||
Pre Funded Warrant | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants issued (in shares) | 805,465 | 433,333 | |||||
Board Members | |||||||
Related Party Transaction [Line Items] | |||||||
Common stock, number of shares held (in shares) | 100,497 | 110,474 | |||||
Reedy Creek Investments LLC | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants owned (in shares) | 395,000 | ||||||
Reedy Creek Investments LLC | Novan, Inc. | Minimum | |||||||
Related Party Transaction [Line Items] | |||||||
Beneficial ownership percentage | 5.00% | ||||||
Sabby | |||||||
Related Party Transaction [Line Items] | |||||||
Common stock issued during period (in shares) | 620,000 | ||||||
Sabby | Pre Funded Warrant | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants issued (in shares) | 260,233 | ||||||
Sabby | Pre Funded Warrant | Common Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ 3,800 | ||||||
Joseph Moglia | |||||||
Related Party Transaction [Line Items] | |||||||
Common stock issued during period (in shares) | 100,000 | ||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ 430 |
Assets Held for Sale, Impairm_2
Assets Held for Sale, Impairment Charges (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2021 | Jun. 29, 2020 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Property carrying value | $ 2,406 | $ 2,406 | $ 12,201 | |||
Right-of-use lease assets | 0 | 0 | $ 1,693 | |||
Impairment loss on long-lived assets | 144 | $ 2,421 | 114 | |||
Right-of-use asset, leasehold improvements and other property | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Property carrying value | $ 8,227 | |||||
Other assets held and used | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Property carrying value | 505 | |||||
Fair value of asset group | 0 | |||||
Impairment of long-lived assets | 505 | |||||
Manufacturing and laboratory equipment | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Property carrying value | 500 | 500 | 744 | |||
Furniture and equipment | Disposal Group, Held-for-sale, Not Discontinued Operations | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Carrying value of disposal group | 454 | |||||
Fair value less costs to sell | 265 | |||||
Impairment charge on held for sale assets | 189 | |||||
Manufacturing and laboratory equipment | Disposal Group, Held-for-sale, Not Discontinued Operations | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Carrying value of disposal group | $ 356 | 356 | $ 356 | 1,510 | ||
Fair value less costs to sell | 712 | |||||
Impairment charge on held for sale assets | $ 114 | 798 | ||||
Primary Facility Lease | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Right-of-use lease assets | 1,816 | |||||
Restricted cash | 539 | |||||
Impairment of long-lived assets | $ 929 | |||||
Primary Facility Lease | Right-of-use asset, leasehold improvements and other property | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Fair value of asset group | 7,298 | |||||
Primary Facility Lease | Leasehold improvements | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Property carrying value | $ 5,872 |
Asset Group Disposition - Narra
Asset Group Disposition - Narrative (Details) - USD ($) | Jul. 16, 2020 | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 29, 2020 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Gain (loss) on disposal | $ 0 | $ (1,772,000) | |||||
Furniture and equipment | Disposal Group, Held-for-sale, Not Discontinued Operations | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Gain (loss) on disposal | $ 0 | ||||||
Carrying value of disposal group | $ 454,000 | ||||||
Impairment charge on held for sale assets | $ 189,000 | ||||||
Manufacturing and laboratory equipment | Disposal Group, Held-for-sale, Not Discontinued Operations | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Gain (loss) on disposal | 0 | ||||||
Net proceeds | 242,000 | 242,000 | |||||
Carrying value of disposal group | 356,000 | 356,000 | 356,000 | $ 1,510,000 | |||
Property and equipment, net | 114,000 | 114,000 | |||||
Impairment charge on held for sale assets | $ 114,000 | $ 798,000 | |||||
Primary Facility Lease | Held and used | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Gain (loss) on disposal | (1,772,000) | ||||||
Property and equipment, net | $ 4,902,000 | ||||||
Total facility group assets | 7,257,000 | ||||||
Total facility group liabilities | 5,951,000 | ||||||
Net carrying value of facility asset group | $ 1,306,000 | ||||||
Other direct disposal costs | $ 466,000 | $ 466,000 |
Asset Group Disposition - Loss
Asset Group Disposition - Loss on Facility Asset Group Disposition (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jul. 16, 2020 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Loss on facility asset group disposition | $ 0 | $ 1,772 | ||
Held and used | Primary Facility Lease | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Property and Equipment, net | $ 4,902 | |||
Restricted cash (security deposit) | 539 | |||
Right-of-use assets | 1,816 | |||
Total facility group assets | 7,257 | |||
Lease liabilities, current portion | (1,169) | |||
Lease liabilities, net of current portion | (4,782) | |||
Total facility group liabilities | (5,951) | |||
Net carrying value of facility asset group | $ 1,306 | |||
Other direct disposal costs | $ 466 | 466 | ||
Loss on facility asset group disposition | $ 1,772 |