Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2021 | May 04, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
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, $0.0001 par value | |
Trading Symbol | NOVN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 151,707,150 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001467154 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 32,661 | $ 35,879 |
Contracts and grants receivable | 4,563 | 4,863 |
Prepaid insurance | 1,239 | 1,818 |
Prepaid expenses and other current assets | 964 | 1,333 |
Other current asset related to leasing arrangement, net | 1,637 | 0 |
Assets held for sale | 114 | 114 |
Total current assets | 41,178 | 44,007 |
Restricted cash | 472 | 0 |
Intangible assets | 75 | 75 |
Other assets | 321 | 341 |
Property and equipment, net | 3,493 | 2,406 |
Right-of-use lease assets | 1,444 | 0 |
Total assets | 46,983 | 46,829 |
Current liabilities: | ||
Accounts payable | 1,001 | 1,192 |
Accrued compensation | 507 | 1,154 |
Accrued outside research and development services | 996 | 930 |
Accrued legal and professional fees | 215 | 168 |
Other accrued expenses | 1,071 | 801 |
Deferred revenue, current portion | 2,990 | 2,990 |
Paycheck Protection Program loan, current portion | 836 | 478 |
Research and development service obligation liability, current portion | 969 | 987 |
Total current liabilities | 8,585 | 8,700 |
Deferred revenue, net of current portion | 7,834 | 8,238 |
Paycheck Protection Program loan, net of current portion | 120 | 478 |
Lease liabilities | 3,120 | 0 |
Research and development service obligation liability, net of current portion | 649 | 649 |
Research and development funding arrangement liability | 25,000 | 25,000 |
Other long-term liabilities | 825 | 787 |
Total liabilities | 46,133 | 43,852 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity | ||
Common stock $0.0001 par value; 200,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 151,662,650 and 145,709,591 shares issued as of March 31, 2021 and December 31, 2020, respectively; 151,653,150 and 145,700,091 shares outstanding as of March 31, 2021 and December 31, 2020, respectively | 15 | 14 |
Additional paid-in capital | 259,219 | 252,395 |
Treasury stock at cost, 9,500 shares as of March 31, 2021 and December 31, 2020 | (155) | (155) |
Accumulated deficit | (258,229) | (249,277) |
Total stockholders’ equity | 850 | 2,977 |
Total liabilities and stockholders’ equity | $ 46,983 | $ 46,829 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares | Mar. 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) | 151,662,650 | 145,709,591 |
Common stock, shares outstanding (in shares) | 151,653,150 | 145,700,091 |
Treasury stock (in shares) | 9,500 | 9,500 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Total revenue | $ 819 | $ 1,213 |
Operating expenses: | ||
Research and development | 6,418 | 4,916 |
General and administrative | 2,686 | 2,507 |
Total operating expenses | 9,104 | 7,423 |
Operating loss | (8,285) | (6,210) |
Other (expense) income, net: | ||
Interest income | 3 | 35 |
Other (expense) income | (670) | 8 |
Total other (expense) income, net | (667) | 43 |
Net loss | (8,952) | (6,167) |
Comprehensive loss | $ (8,952) | $ (6,167) |
Net loss per share, basic and diluted (in USD per share) | $ (0.06) | $ (0.17) |
Weighted-average common shares outstanding, basic and diluted (in shares) | 150,028,864 | 37,043,876 |
License and collaboration revenue | ||
License and collaboration revenue | $ 747 | $ 1,024 |
Government research contracts and grants revenue | ||
Government research contracts and grants revenue | $ 72 | $ 189 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) (unaudited) - USD ($) $ in Thousands | Total | Common Stock Purchase Agreement | Common Warrant | Pre Funded WarrantPublic Offering | Pre Funded WarrantRegistered Direct Offering | Common Stock | Common StockCommon Stock Purchase Agreement | Common StockCommon Warrant | Common StockPre Funded WarrantPublic Offering | Common StockPre Funded WarrantRegistered Direct Offering | Additional Paid-In Capital | Additional Paid-In CapitalCommon Stock Purchase Agreement | Additional Paid-In CapitalCommon Warrant | Additional Paid-In CapitalPre Funded WarrantPublic Offering | Additional Paid-In CapitalPre Funded WarrantRegistered Direct Offering | Treasury Stock | Accumulated Deficit |
Beginning balance, in shares (in shares) at Dec. 31, 2019 | 26,734,800 | ||||||||||||||||
Beginning balance at Dec. 31, 2019 | $ (22,283) | $ 3 | $ 197,853 | $ (155) | $ (219,984) | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||
Share-based compensation | 385 | 385 | |||||||||||||||
Exercise of warrants | $ 2,880 | $ 0 | $ 0 | $ 1 | $ 0 | $ 0 | $ 2,879 | $ 0 | $ 0 | ||||||||
Exercise of warrants (in shares) | 9,600,000 | 4,333,334 | 4,602,326 | ||||||||||||||
Common stock issued during period (in shares) | 700,000 | 15,498,602 | 10,550,000 | ||||||||||||||
Common stock issued during period | $ 442 | $ 5,158 | $ 7,225 | $ 0 | $ 2 | $ 1 | $ 442 | $ 5,156 | $ 7,224 | ||||||||
Net loss | (6,167) | (6,167) | |||||||||||||||
Ending balance, in shares (in shares) at Mar. 31, 2020 | 72,019,062 | ||||||||||||||||
Ending balance at Mar. 31, 2020 | $ (12,360) | $ 7 | 213,939 | (155) | (226,151) | ||||||||||||
Beginning balance, in shares (in shares) at Dec. 31, 2020 | 145,700,091 | 145,700,091 | |||||||||||||||
Beginning balance at Dec. 31, 2020 | $ 2,977 | $ 14 | 252,395 | (155) | (249,277) | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||
Share-based compensation | $ 36 | 36 | |||||||||||||||
Exercise of warrants | $ 442 | $ 0 | $ 442 | ||||||||||||||
Exercise of warrants (in shares) | 996,509 | ||||||||||||||||
Common stock issued during period (in shares) | 4,931,633 | ||||||||||||||||
Common stock issued during period | $ 6,334 | $ 1 | $ 6,333 | ||||||||||||||
Exercise of stock options (in shares) | 24,917 | 24,917 | |||||||||||||||
Exercise of stock options | $ 13 | $ 0 | 13 | ||||||||||||||
Net loss | $ (8,952) | (8,952) | |||||||||||||||
Ending balance, in shares (in shares) at Mar. 31, 2021 | 151,653,150 | 151,653,150 | |||||||||||||||
Ending balance at Mar. 31, 2021 | $ 850 | $ 15 | $ 259,219 | $ (155) | $ (258,229) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flow from operating activities: | ||
Net loss | $ (8,952) | $ (6,167) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 57 | 495 |
Stock-based compensation | 80 | 272 |
Foreign currency transaction (gain) loss | 669 | 0 |
Loss on disposal and write-offs of property and equipment | 0 | 44 |
Changes in operating assets and liabilities: | ||
Contracts and grants receivable | (43) | 230 |
Prepaid insurance, prepaid expenses and other current assets | 948 | 125 |
Accounts payable | (226) | (692) |
Accrued compensation | (647) | 670 |
Accrued outside research and development services | 66 | 915 |
Accrued legal and professional fees | 47 | (508) |
Other accrued expenses | 103 | (52) |
Deferred revenue | (747) | (1,143) |
Research and development service obligation liabilities | (18) | (1,513) |
Other long-term assets and liabilities | 62 | (114) |
Net cash used in operating activities | (8,601) | (7,438) |
Cash flow from investing activities: | ||
Purchases of property and equipment | (934) | (352) |
Proceeds from the sale of property and equipment | 0 | 15 |
Net cash used in investing activities | (934) | (337) |
Cash flow from financing activities: | ||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | 0 | 12,577 |
Proceeds from exercise of common stock warrants | 442 | 2,880 |
Proceeds from issuance of common stock under common stock purchase agreement | 6,334 | 442 |
Payments related to public offering costs | 0 | (26) |
Payments of offering costs related to registration statement | 0 | (25) |
Proceeds from exercise of stock options | 13 | 0 |
Net cash provided by financing activities | 6,789 | 15,848 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (2,746) | 8,073 |
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 | 33,133 | 22,324 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Purchases of property and equipment with accounts payable and accrued expenses | 592 | 6 |
Right-of-use assets obtained in exchange for lease liabilities | 1,444 | 0 |
Deferred offering costs in accounts payable and accrued expenses | 0 | 152 |
Deferred offering costs reclassified to additional paid-in capital | 0 | 16 |
Reconciliation to condensed consolidated balance sheets: | ||
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 33,133 | $ 22,324 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 3 Months Ended |
Mar. 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 clinical development-stage biotechnology company focused on leveraging nitric oxide’s naturally occurring anti-viral, anti-bacterial, anti-fungal and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. 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 condensed 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”). The December 31, 2020 year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. Additionally, the Company’s independent registered public accounting firm report for the December 31, 2020 financial statements included an explanatory paragraph indicating that there is substantial doubt about the Company’s ability to continue as a going concern. Basis of Consolidation The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Liquidity and Ability to Continue as a Going Concern The Company’s condensed 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 condensed 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 March 31, 2021, the Company had an accumulated deficit of $258,229. • As of March 31, 2021, the Company had a total cash and cash equivalents balance of $32,661. • 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 three months ended March 31, 2021, the Company received aggregate net proceeds of $6,334 from the July 2020 Aspire CSPA and, as of March 31, 2021, had $12,005 in remaining availability for sales of its common stock under the July 2020 Aspire CSPA. • As described in Note 10—Stockholders’ Equity (Deficit), in early March 2020 the Company completed a public offering of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and common warrants to purchase common stock pursuant to the Company’s then effective shelf registration statement (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. The Company has also received proceeds from the exercise of common warrants issued in the March 2020 Public Offering of approximately $5,557 through March 31, 2021. • As described in Note 10—Stockholders’ Equity (Deficit), in late March 2020 the Company completed a registered direct offering of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) pursuant to the Company’s then-effective shelf registration statement (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. • 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 potentially begins commercialization activities. • The Company has concluded that the prevailing conditions and ongoing liquidity risks faced by the Company, coupled with uncertainty regarding the top-line efficacy results expected in the pivotal Phase 3 trial for SB206 as a treatment for molluscum contagiosum (“molluscum”, and such trial, the “B-SIMPLE4 Phase 3 trial”), which are currently targeted before the end of the second quarter of 2021, raise substantial doubt about its ability to continue as a going concern. The 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. The Company believes that its existing cash and cash equivalents balance as of March 31, 2021, plus expected contractual payments to be received in connection with existing licensing agreements, will provide it with adequate liquidity to fund its planned operating needs into the first quarter of 2022. This operating forecast and related cash projection includes: (i) costs through the expected completion of the B-SIMPLE4 Phase 3 trial, including supporting activities; (ii) preparatory costs associated with the anticipated continued regulatory progression of SB206; (iii) development activities in certain priority therapeutic areas, including infectious disease ( Coronaviridae (COVID-19)) and companion animal health; (iv) conducting drug manufacturing capability transfer activities to external third-party contract manufacturing organizations (“CMOs”), including a drug delivery device technology enhancement project; and (v) certain build-out and manufacturing capability costs related to the infrastructure necessary to support small-scale drug substance and drug product manufacturing at its new corporate headquarters, but excludes any potential costs associated with other late-stage clinical development programs and 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, the impact of outside factors such as the COVID-19 pandemic, its ability to enter into strategic arrangements, its ability to access additional capital and its financial priorities. The Company will need significant additional funding to continue its operating activities and make further advancements in its product development programs beyond those currently included in its operating forecast and related cash projection. The Company does not currently have sufficient funds to complete development and commercialization of any of its product candidates. 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 needs and intends to 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 equity issuances during the year ended December 31, 2020, and the three months ended March 31, 2021, have resulted in significant dilution to its existing stockholders. Any future additional issuances of equity, or debt that could be convertible into equity, would result in further significant dilution to the Company’s existing stockholders. As of March 31, 2021 the Company had 151,653,150 shares of common stock outstanding. In addition, as of March 31, 2021, the Company had reserved 15,856,608 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, 2020, the Company had 145,700,091 shares of its common stock outstanding, with an additional 16,903,031 reserved for future issuance. The Company’s common stock consists of 200,000,000 authorized shares as of March 31, 2021 and December 31, 2020. At the Annual Meeting held on May 4, 2021, the Company’s stockholders did not approve the proposal to amend the Company’s restated certificate of incorporation to increase the total number of authorized shares of its common stock from 200,000,000 to 250,000,000 shares. Because the Company’s stockholders did not approve an increase in authorized shares, without implementing a potential reverse stock split that would reduce the number of outstanding shares of its common stock and thereby increase the shares available for issuance, the Company may not have the ability to raise additional capital as needed to support development, regulatory approval and potential commercialization of its product candidates. See Note 14—Subsequent Events regarding the Annual Meeting held on May 4, 2021 and the proposal to amend the Company’s restated certificate of incorporation to increase the number of authorized shares of the Company’s common stock. Rather than raising additional capital, or if the Company is unable to raise additional capital on terms acceptable to the Company or at all, the Company may seek to engage in one or more potential transactions, such as the sale of the Company, or sale or divestiture of some of its assets, such as a sale of its dermatology platform assets, but there can be no assurance that the Company will be able to enter into such a transaction or transactions on a timely basis or at all on terms that are favorable to the Company. Under these circumstances, the Company 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 2019 (“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 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 (including its variant strains), and the actions taken by other parties, such as governmental authorities, to contain and treat COVID-19. 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. In particular, COVID-19 impacted the timing of trial initiation of the Company’s B-SIMPLE4 Phase 3 trial, and, while the Company enrolled and dosed the first patient in the trial in September 2020 and fully enrolled the trial in the first quarter of 2021, the Company plans to continue to assess any further impact of COVID-19 on the B-SIMPLE4 Phase 3 trial. Despite disruptions to the Company’s business operations and the business operations of third parties on which the Company relies, the COVID-19 pandemic has not significantly impacted the Company’s operating results and financial condition to date. However, at this time, the extent to which COVID-19 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. Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements and the related footnote disclosures are unaudited. These unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the Securities and Exchange Commission’s (“SEC”) Rule 10-01 of Regulation S-X for interim financial information. The condensed consolidated financial statements were prepared on the same basis as the audited consolidated financial statements and in the opinion of management, reflect all adjustments of a normal, recurring nature that are necessary for the fair statement of the Company’s financial position and its results of operations and cash flows. The results of operations for interim periods are not necessarily indicative of the results expected for the full fiscal year or any future period. These interim financial statements should be read in conjunction with the consolidated financial statements and notes for the year ended December 31, 2020 set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on February 24, 2021. 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. Restricted Cash Restricted cash as of March 31, 2021 includes funds maintained in a deposit account to secure a letter of credit for the benefit of the TBC Landlord (as defined below). See Note 8—Commitments and Contingencies for further information regarding the letter of credit and the TBC Lease (as defined below). Net Loss Per Share Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders 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. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are anti-dilutive for all periods presented. The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average common shares outstanding for the three months ended March 31, 2021 and March 31, 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. March 31, 2021 2020 Warrants to purchase common stock (Note 10) 12,780,756 22,636,432 Stock options outstanding under the 2008 and 2016 Plans (Note 11) 1,922,522 2,010,603 Stock appreciation rights outstanding under the 2016 Plan (Note 11) 610,000 600,000 Inducement stock options outstanding (Note 11) 62,503 96,167 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. Although all operations are based in the United States, the Company generated revenue from its licensing partner in Japan of $747, or approximately 91% of total revenue, and $1,024, or approximately 84% of total revenue during the three months ended March 31, 2021 and 2020, respectively. Recently Issued Accounting Standards Accounting Pronouncements Adopted In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 condensed 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 adoption of this new accounting guidance did not have a material impact on the Company’s condensed consolidated financial statements. |
KNOW Bio, LLC
KNOW Bio, LLC | 3 Months Ended |
Mar. 31, 2021 | |
Business Combinations [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 three months ended March 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 | 3 Months Ended |
Mar. 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 required to make payments based upon achievement of certain 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. 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, 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. Unless earlier terminated by the Company at its election, or if the Company materially breaches the agreement or becomes bankrupt, the UNC License Agreement remains in effect on a country by country and licensed product by licensed product basis |
Licensing Arrangements
Licensing Arrangements | 3 Months Ended |
Mar. 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 active pharmaceutical ingredient (“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. • 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. The Amended Sato Agreement may be terminated by (i) Sato without cause upon 120 days’ advance written notice to the Company; (ii) either party in the event of the other party’s uncured material breach upon 60 days’ advance written notice; (iii) force majeure; (iv) either party in the event of the other party’s dissolution, liquidation, bankruptcy or insolvency; and (v) the Company immediately upon written notice if Sato challenges the validity, patentability, or enforceability of any of the Company’s patents or patent applications licensed to Sato under the Amended Sato Agreement. In the event of a termination, no portion of the upfront fees received from Sato are refundable. 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 anti-viral gel being developed for the treatment of molluscum, 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 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 Accounting Standards Codification (“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 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 anti-viral gel being developed for the treatment of molluscum. 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, for the treatment of molluscum. 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 condensed 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 condensed consolidated statements of operations and comprehensive loss as an offset to 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. For the three months ended March 31, 2021 and 2020, the Company recorded $18 and $1,513, respectively, as contra-research and development expense related to the SB206 developmental program, funded by Ligand. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 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 March 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. 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 March 31, 2021 $ 4,500 $ 15,324 $ 10,824 Short-term Deferred Revenue Long-term Deferred Revenue Net Deferred Revenue December 31, 2020 $ 2,990 $ 8,238 $ 11,228 March 31, 2021 $ 2,990 $ 7,834 $ 10,824 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 three months ended March 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); and (ii) the impact of foreign currency exchange rate fluctuations. As of March 31, 2021 and December 31, 2020, the Company had an unconditional right to receive consideration of $4,500 and $4,843, respectively, based on a time-based developmental milestone payment that became due and payable as of December 31, 2020. Therefore, as of March 31, 2021 and December 31, 2020, the Company presented this milestone payment in contracts and grants receivable within its condensed consolidated balance sheets. During the three months ended March 31, 2021 and 2020, the Company recognized $747 and $1,024, respectively, in license and collaboration revenue under this agreement. During the three months ended March 31, 2021, the Company recognized $686 related to foreign currency adjustments related to the contract asset and contract receivable, presented within other expense, net within the accompanying condensed 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 March 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 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 potential evaluation of 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 estimates 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. This 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 expected top-line efficacy results, currently targeted before the end of the second quarter of 2021, from the B-SIMPLE4 Phase 3 trial 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 build-out of further 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 of 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. In future periods, the Company will lift the variable consideration constraint from each contingent payment when there is no longer a probable likelihood of significant revenue reversal. When the constraint is lifted from a milestone payment, the Company will recognize the incremental transaction price using the same time-based input method that is being used to recognize the revenue, which results in straight-line recognition over the performance period. If the Company’s performance is not yet completed at the time that the constraint is lifted, a cumulative catch-up adjustment will be recognized in the period. If no other performance is required by the Company at the time the constraint is lifted, the Company expects to recognize all revenue associated with such milestone payments at the time that the constraint is lifted. 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. Performance Obligations under the Amended Sato Agreement The net amount of existing performance obligations under long-term contracts unsatisfied as of March 31, 2021 was $10,824. 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 in vitro studies. 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 was awarded additional funding of $126 in March 2021 and may be eligible to receive additional funding as part of the NIH Phase 2 Grant, all of which was or will be subject to availability of NIH funds and satisfactory progress of the project. Revenue recognized under the NIH Phase 1 Grant and NIH Phase 2 Grant was $62 and $24 during the three months ended March 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 $165 during the three months ended March 31, 2021 and 2020, respectively. |
Research and Development Arrang
Research and Development Arrangements | 3 Months Ended |
Mar. 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 active pharmaceutical ingredient (“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. • 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. The Amended Sato Agreement may be terminated by (i) Sato without cause upon 120 days’ advance written notice to the Company; (ii) either party in the event of the other party’s uncured material breach upon 60 days’ advance written notice; (iii) force majeure; (iv) either party in the event of the other party’s dissolution, liquidation, bankruptcy or insolvency; and (v) the Company immediately upon written notice if Sato challenges the validity, patentability, or enforceability of any of the Company’s patents or patent applications licensed to Sato under the Amended Sato Agreement. In the event of a termination, no portion of the upfront fees received from Sato are refundable. 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 anti-viral gel being developed for the treatment of molluscum, 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 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 Accounting Standards Codification (“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 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 anti-viral gel being developed for the treatment of molluscum. 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, for the treatment of molluscum. 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 condensed 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 condensed consolidated statements of operations and comprehensive loss as an offset to 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. For the three months ended March 31, 2021 and 2020, the Company recorded $18 and $1,513, respectively, as contra-research and development expense related to the SB206 developmental program, funded by Ligand. |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment consisted of the following: March 31, 2021 December 31, 2020 Computer equipment $ 67 $ 67 Furniture and fixtures 34 34 Laboratory equipment 3,210 2,930 Office equipment 137 72 Leasehold improvements 1,362 562 Property and equipment, gross 4,810 3,665 Less: Accumulated depreciation and amortization (1,317) (1,259) Total property and equipment, net $ 3,493 $ 2,406 Depreciation and amortization expense was $57 and $495 for the three months ended March 31, 2021 and 2020, respectively. During the second quarter of 2020, the Company met the relevant criteria for reporting certain property and equipment 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 condensed 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 facility asset group on July 16, 2020 in conjunction with the lease termination transaction described in Note 8—Commitments and Contingencies. As of March 31, 2021, the Company had $114 of disposal group carrying value remaining, which continues to be classified as assets held for sale in the accompanying condensed consolidated balance sheets. This |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 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. Hopson Road Facility Lease 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 “Hopson Road 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 Hopson Road Facility Lease, subject to certain conditions. Pursuant to the terms of the Termination Agreement, the Hopson Road 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 Hopson Road Facility Lease (the “New Tenant Lease”), which commenced on July 16, 2020. In connection with the termination of the Hopson Road Facility Lease pursuant to the Termination Agreement, the Company entered into a sublease agreement, which was effective upon the termination of the Hopson Road 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 Hopson Road 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 Hopson Road Facility Lease pursuant to the Termination Agreement, and, in connection with the termination of the Hopson Road Facility Lease, the Landlord consented to the Sublease. The Company decommissioned and physically exited the premises covered by the Sublease during the three months ended March 31, 2021, and the Sublease’s material terms expired on March 31, 2021. Triangle Business Center Facility Lease On January 18, 2021, the Company entered into a Lease, dated as of January 18, 2021, as amended as of March 18, 2021 (the “TBC Lease”), by and between the Company and Copper II 2020, LLC (the “TBC Landlord”), pursuant to which the Company will lease 15,623 rentable square feet located at a new location (the “Premises”). The Premises will serve as the Company’s new corporate headquarters. The Company is building out the Premises 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 TBC Lease commenced on January 18, 2021 (the “Lease Commencement Date”). Rent under the TBC Lease commences on the earlier of (i) the date the Company occupies a certain portion of the Premises, as specified in the TBC Lease, for the purposes of conducting business therein, or (ii) nine months after the Lease Commencement Date, provided that the date for purposes of (ii) is subject to extension for any delay in the TBC Landlord’s delivery of the Premises to the Company in accordance with certain specifications set forth in the TBC Lease (the “Rent Commencement Date”). The term of the TBC Lease expires on the last day of the one hundred twenty-third calendar month after the Rent Commencement Date immediately preceding the tenth anniversary of the Lease Commencement Date (and if the Rent Commencement Date does not occur on the first day of a calendar month, the period from the Rent Commencement Date to the first day of the next calendar month shall be included in the first such month for purposes of determining the duration of the term of the TBC Lease). The TBC Lease provides the Company with one option to extend the term of the TBC Lease for a period of five years, which would commence upon the expiration of the original term of the TBC Lease, with base rent of a market rate determined according to the TBC 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 will be approximately $40 for months 1-12. Beginning with month 13 and annually thereafter, the monthly base rent will be increased by 3%. Subject to certain terms, the TBC 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 TBC Lease. The TBC 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. The tenant improvement allowance will be paid over four equal installments corresponding with work performed by the Company. Pursuant to the terms of the TBC Lease, the Company delivered to the TBC Landlord a letter of credit in the amount of $472 as collateral for the full performance by the Company of all of its obligations under the TBC Lease and for all losses and damages the TBC Landlord may suffer as a result of any default by the Company under the TBC 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 condensed consolidated balance sheets. Rent expense, including both short-term and variable lease components associated with the Hopson Road Facility Lease and the TBC Lease, as applicable, was $145 and $224 for the three months ended March 31, 2021 and 2020, respectively. The weighted average remaining lease term for the TBC Lease and weighted average discount rate for the TBC Lease are 10.75 years and 8.35%, respectively, as of March 31, 2021. Future net minimum lease payments as of March 31, 2021 were as follows: Maturity of Lease Liabilities Operating Lease 2021 $ (1,991) 2022 481 2023 496 2024 511 2025 526 2026 and beyond 3,451 Total future undiscounted lease payments $ 3,474 Add: reclassification of discounted net cash inflows to other current assets $ 1,637 Less: imputed interest $ (1,991) Total reported lease liability $ 3,120 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 2021 fiscal year presented above relates to the expected timing of the tenant improvement allowance of $2,031 being funded by the TBC Landlord, which the Company reasonably expects to receive by December 31, 2021, partially offset by expected lease payments for the year ended December 31, 2021. Components of lease assets and liabilities as of March 31, 2021 were as follows: As of March 31, 2021 Leases Assets Other current asset related to leasing arrangement, net $ 1,637 Right-of-use lease assets 1,444 Total assets $ 3,081 Liabilities Other long-term liabilities - operating lease $ 3,120 Total lease liabilities $ 3,120 The effective discounted value of the payments of the tenant improvement allowance of $2,031, being funded by the TBC Landlord, partially offset by the expected lease payments by the Company for the year ended December 31, 2021, results in a net balance of $1,637 which is presented within the condensed consolidated balance sheets as other current asset related to leasing arrangement, net as of March 31, 2021. Furthermore, this amount is also included in long-term lease liabilities within the condensed consolidated balance sheets as of March 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, in addition to potential third-party manufacturers for the manufacture of our product candidates. 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 March 31, 2021. 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. 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 As part of a strategic objective to reduce the Company’s costs related to internal resources, facilities, and infrastructure capabilities, the Company took actions in February 2020 to reduce the Company’s internal resources. Employee severance costs associated with this action were $59, which were expensed during the first quarter of 2020. See Note 11—Stock-Based Compensation regarding the Stock Appreciation Rights granted in January 2020. See Note 12—Tangible Stockholder Return Plan regarding the Tangible Stockholder Return Plan adopted in August 2018. |
Paycheck Protection Program
Paycheck Protection Program | 3 Months Ended |
Mar. 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 bears interest at a fixed rate of one percent (1%) per annum. Principal and interest on unforgiven amounts are payable monthly commencing on the fifteenth day of the month following the First Payment Date, as defined within the Note. The Note provides that the Loan may be prepaid by the Company at any time prior to the April 22, 2022 maturity date without penalty. The Company has applied for forgiveness and has presented a portion of the Loan within current liabilities in the accompanying condensed consolidated balance sheets. The short-term portion was estimated using the maximum Deferral Expiration Date, as defined within the Note, based on the related latest potential timing of payments with regards to any unforgiven amounts. The overall timing of payments with respect to the amounts of principal and interest due could change based on the ultimate determination of the extent to which the Loan, including interest accrued thereon, is forgiven, if at all. 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. No assurance is provided that the Company will obtain forgiveness of the Loan in whole or in part. The Company will be obligated to repay any portion of the principal amount of the Loan that is not forgiven, together with interest accrued and accruing thereon at the rate set forth above, until such unforgiven portion is paid in full. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 3 Months Ended |
Mar. 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 further amended its restated certificate of incorporation and amended and restated its bylaws. The amendment provides 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. See Note 14—Subsequent Events regarding the Annual Meeting held on May 4, 2021 and the proposal to amend the Company’s restated certificate of incorporation to increase the number of authorized shares of the Company’s common stock. 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 14,000,000 shares of common stock, pre-funded warrants to purchase 4,333,334 shares of common stock (the “CMPO Pre-Funded Warrants”), and accompanying common warrants to purchase up to an aggregate of 18,333,334 shares of common stock (the “firm warrants”). The Company also granted H.C. Wainwright, as underwriter, a 30-day option to purchase up to 2,750,000 additional shares of common stock and/or common warrants to purchase up to an aggregate of 2,750,000 shares of common stock, which H.C. Wainwright partially exercised on March 2, 2020 to purchase 1,498,602 shares of common stock and common warrants to purchase 2,750,000 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 $0.30, and the combined price to the public in this offering for each pre-funded warrant and accompanying common warrant was $0.2999. 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 594,958 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 $0.0001 per share. The CMPO Common Warrants have an exercise price of $0.30 per share and expire five years from the date of issuance. During the three months ended March 31, 2021, warrant holders exercised 62,500 of the CMPO Common Warrants for total proceeds of approximately $18. From the March 3, 2020 closing date of the March 2020 public offering through March 31, 2021, warrant holders exercised a total of 18,521,667 of the CMPO Common Warrants for total proceeds of approximately $5,557. There were 2,561,667 of the CMPO Common Warrants outstanding as of March 31, 2021. The CMPO UW Warrants have an exercise price of $0.375 per share and expire five years from the date of issuance. During the three months ended March 31, 2021, warrant holders exercised 481,916 of the CMPO UW Warrants for total proceeds of approximately $181. None of the CMPO UW Warrants were exercised during 2020. There were 113,042 of the CMPO UW Warrants outstanding as of March 31, 2021. 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. 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. 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 10,550,000 shares of the Company’s common stock and pre-funded warrants to purchase 8,054,652 shares of common stock (the “RDO Pre-Funded Warrants”). The purchase price for each share of common stock was $0.43, and the price for each pre-funded warrant was $0.4299. 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 558,140 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 quarter of 2020, warrant holders exercised 4,602,326 of the RDO Pre-Funded Warrants. From the March 26, 2020 closing date of the March 2020 Registered Direct Offering through December 31, 2020, warrant holders exercised all of the 8,054,652 RDO Pre-Funded Warrants that were issued, and none of the RDO Pre-Funded Warrants were outstanding as of March 31, 2021. The RDO Pre-Funded Warrants had an exercise price of $0.0001 per share. The RDO PA Warrants have an exercise price of $0.5375 per share and expire five years from the date of issuance. None of the RDO PA Warrants were exercised during the year ended December 31, 2020. During the three months ended March 31, 2021, warrant holders exercised 452,093 of the RDO PA Warrants for total proceeds of approximately $243, and there were 106,047 of the RDO PA Warrants outstanding as of March 31, 2021. 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. 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. 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 10,000,000 shares of common stock and warrants to purchase up to 10,000,000 shares of the Company’s common stock at a public offering price of $3.80 per share of common stock and accompanying warrant. The warrant exercise price is $4.66 per share and will expire four years from the date of issuance. Based on the results of the Company’s assessment of the warrants for appropriate equity or liability classification, the Company determined that the warrants issued in connection with the January 2018 Offering are freestanding equity-linked derivative instruments that met the criteria for the own-equity scope exception to derivative accounting under ASC 815. Accordingly, such warrants were classified as equity and were accounted for as a component of additional paid-in capital at the time of issuance. There were no exercises of warrants issued in the January 2018 Offering during the three months ended March 31, 2021 or 2020. The following table presents outstanding warrants to purchase the Company’s common stock for the periods indicated. March 31, 2021 December 31, 2020 Exercise Warrants to purchase common stock issued in the January 2018 Offering 10,000,000 10,000,000 $ 4.66 Warrants to purchase common stock issued in the March 2020 Public Offering 2,561,667 2,624,167 0.30 Underwriter warrants to purchase common stock associated with the March 2020 Public Offering 113,042 594,958 0.375 Placement agent warrants to purchase common stock issued in the March 2020 Registered Direct Offering 106,047 558,140 0.5375 12,780,756 13,777,265 The weighted average exercise price per share for warrants outstanding as of March 31, 2021 and December 31, 2020 was $3.71 and $3.48, respectively. 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 5,555,555 shares of its common stock at $0.90 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 1,000,000 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 condensed 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. 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 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 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 300,000 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 2,000,000 shares. In addition, on any date on which the Company submits a July 2020 Purchase Notice to Aspire Capital in an amount equal to 300,000 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 25,433,642 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 $0.5907, 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. During the three months ended March 31, 2021, the Company sold 4,931,633 shares of its common stock at an average price of $1.28 for total proceeds of $6,334. From the inception of the July 2020 Aspire CSPA, as of March 31, 2021, the Company has sold 22,210,397 shares of its common stock at an average price of $0.81 per share, including 5,555,555 shares of its common stock at $0.90 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 March 31, 2021, the Company had $12,005 in remaining availability for sales of its common stock under the July 2020 Aspire CSPA. Common Stock The Company’s common stock has a par value of $0.0001 per share and consists of 200,000,000 authorized shares as of March 31, 2021 and December 31, 2020. There were 151,653,150 and 145,700,091 shares of voting common stock outstanding as of March 31, 2021 and December 31, 2020, respectively. The Company had reserved shares of common stock for future issuance as follows: March 31, 2021 December 31, 2020 Outstanding warrants to purchase common stock 12,780,756 13,777,265 Outstanding stock options (Note 11) 1,985,025 1,991,964 Outstanding stock appreciation rights (Note 11) 610,000 610,000 For possible future issuance under the 2016 Stock Plan (Note 11) 480,827 523,802 15,856,608 16,903,031 Preferred Stock The Company’s restated certificate of incorporation provides the Company’s board of directors with the authority to issue $0.0001 par value preferred stock from time to time in one or more series by adopting a resolution and filing a certificate of designations. Voting powers, designations, preferences, dividend rights, conversion rights and liquidation preferences shall be stated and expressed in such resolutions. There were 10,000,000 shares designated as preferred stock and no shares outstanding as of March 31, 2021 and December 31, 2020. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2016 Stock Plan During the three months ended March 31, 2021, the Company continued to administer and grant awards under the 2016 Incentive Award Plan (the “2016 Plan”), the Company’s only active equity incentive plan. Certain of the Company’s outstanding and exercisable stock options remain subject to the terms of the Company’s 2008 Stock Plan (the “2008 Plan”), which is the predecessor to the 2016 Plan and became inactive upon adoption of the 2016 Plan effective September 20, 2016. On July 31, 2019, the Company’s stockholders approved an amendment to the 2016 Plan (“the 2016 Plan Amendment”), to increase the number of shares reserved under the 2016 Plan by 1,000,000 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 250,000 to 1,000,000 shares of the Company’s common stock. All other material terms of the 2016 Plan otherwise remain unchanged. See Note 14—Subsequent Events regarding the Annual Meeting held on May 4, 2021 and the proposal to amend the 2016 Plan to increase the aggregate number of shares of the Company’s common stock that may be issued. 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, 600,000 stock appreciation rights (“SARs”) were granted to Ms. Stafford with an exercise price of $0.82 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 were classified as equity-based awards. The Stafford SAR Award vests quarterly and will vest in full on December 31, 2021, subject to Ms. Stafford’s continuous service as an employee or consultant of the Company through the vesting period. On August 18, 2020, the Company granted 10,000 SARs to a consultant of the Company with an exercise price of $0.53 per share (the fair market value of the Company’s common stock on the grant date) with a ten year term. During the three months ended March 31, 2021 and 2020, the Company recorded employee stock-based compensation expense related to SARs of $29 and $62, respectively. As of March 31, 2021, there were a total of 610,000 SARs outstanding, 385,000 of which were exercisable. Stock Compensation Expense During the three months ended March 31, 2021 and 2020, the Company recorded employee stock-based compensation expense of $80 and $272, respectively. Total stock-based compensation expense included in the accompanying condensed consolidated statements of operations and comprehensive loss is as follows: Three Months Ended March 31, 2021 2020 Research and development $ (52) $ 208 General and administrative 132 64 Total $ 80 $ 272 Stock option activity for the three months ended March 31, 2021 is as follows: Shares Weighted- Weighted- Aggregate Options outstanding as of December 31, 2020 1,991,964 $ 3.07 Options granted 88,970 1.66 Options forfeited (70,992) 4.25 Options exercised (24,917) 0.51 Options outstanding as of March 31, 2021 1,985,025 $ 3.00 7.05 $ 543 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 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. The share price target for the first tranche and related bonus pool are $11.17 per share and $25,000, respectively. The share price target for the second tranche and related bonus pool are $25.45 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 condensed 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 condensed 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 condensed 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. |
Tangible Stockholder Return Pla
Tangible Stockholder Return Plan | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Tangible Shareholder Return Plan | Stock-Based Compensation 2016 Stock Plan During the three months ended March 31, 2021, the Company continued to administer and grant awards under the 2016 Incentive Award Plan (the “2016 Plan”), the Company’s only active equity incentive plan. Certain of the Company’s outstanding and exercisable stock options remain subject to the terms of the Company’s 2008 Stock Plan (the “2008 Plan”), which is the predecessor to the 2016 Plan and became inactive upon adoption of the 2016 Plan effective September 20, 2016. On July 31, 2019, the Company’s stockholders approved an amendment to the 2016 Plan (“the 2016 Plan Amendment”), to increase the number of shares reserved under the 2016 Plan by 1,000,000 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 250,000 to 1,000,000 shares of the Company’s common stock. All other material terms of the 2016 Plan otherwise remain unchanged. See Note 14—Subsequent Events regarding the Annual Meeting held on May 4, 2021 and the proposal to amend the 2016 Plan to increase the aggregate number of shares of the Company’s common stock that may be issued. 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, 600,000 stock appreciation rights (“SARs”) were granted to Ms. Stafford with an exercise price of $0.82 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 were classified as equity-based awards. The Stafford SAR Award vests quarterly and will vest in full on December 31, 2021, subject to Ms. Stafford’s continuous service as an employee or consultant of the Company through the vesting period. On August 18, 2020, the Company granted 10,000 SARs to a consultant of the Company with an exercise price of $0.53 per share (the fair market value of the Company’s common stock on the grant date) with a ten year term. During the three months ended March 31, 2021 and 2020, the Company recorded employee stock-based compensation expense related to SARs of $29 and $62, respectively. As of March 31, 2021, there were a total of 610,000 SARs outstanding, 385,000 of which were exercisable. Stock Compensation Expense During the three months ended March 31, 2021 and 2020, the Company recorded employee stock-based compensation expense of $80 and $272, respectively. Total stock-based compensation expense included in the accompanying condensed consolidated statements of operations and comprehensive loss is as follows: Three Months Ended March 31, 2021 2020 Research and development $ (52) $ 208 General and administrative 132 64 Total $ 80 $ 272 Stock option activity for the three months ended March 31, 2021 is as follows: Shares Weighted- Weighted- Aggregate Options outstanding as of December 31, 2020 1,991,964 $ 3.07 Options granted 88,970 1.66 Options forfeited (70,992) 4.25 Options exercised (24,917) 0.51 Options outstanding as of March 31, 2021 1,985,025 $ 3.00 7.05 $ 543 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 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. The share price target for the first tranche and related bonus pool are $11.17 per share and $25,000, respectively. The share price target for the second tranche and related bonus pool are $25.45 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 condensed 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 condensed 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 condensed 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. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Members of the Company’s board of directors held 1,174,776 and 1,104,776 shares of the Company’s common stock as of March 31, 2021 and December 31, 2020, respectively. Health Decisions On October 25, 2018, the Company announced a foundational collaboration with Health Decisions, Inc. (“Health Decisions”). Health Decisions 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, is also a stockholder and serves 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 3,900,000 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 January 6, 2021, Reedy Creek still beneficially owns greater than 5% of the Company’s outstanding common stock and holds approximately 3,900,000 warrants. 2020 Registered Direct Offering Sabby Volatility Warrant Master Fund, Ltd. (“Sabby”), while a greater than 5% stockholder of the Company, purchased 6,200,000 shares of common stock and pre-funded warrants to purchase up to 2,602,326 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 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events 2021 Annual Meeting of Stockholders On May 4, 2021, the Company held its 2021 Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved an amendment to the 2016 Plan to increase the aggregate number of shares of the Company’s common stock authorized for issuance thereunder by 15,000,000 shares. This amendment was approved by the Company’s board of directors on March 10, 2021. The approval by the Company’s stockholders of this proposal is contingent and will be effective upon the earlier to occur of (i) 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 of Stockholders (the “2020 Annual Meeting”), or (ii) an earlier time as determined by the Company’s board of directors in its sole discretion. The Company’s stockholders did not approve the proposal to amend the Company’s restated certificate of incorporation to increase the total number of authorized shares of the Company’s common stock from 200,000,000 to 250,000,000 shares. Because the Company’s stockholders did not approve an increase in authorized shares, without implementing a potential reverse stock split that would reduce the number of outstanding shares of the Company’s common stock and thereby increase the shares available for issuance, the Company may not have the ability to raise additional capital as needed to support development, regulatory approval and potential commercialization of its product candidates. Previously at the 2020 Annual Meeting, the Company’s stockholders approved a proposal to amend the Company’s restated certificate of incorporation to effect a reverse stock split of its 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. The Company’s board of directors will still have the authority to effect a reverse stock split until July 28, 2021, if, in its sole discretion, the board of directors determines that effecting a reverse stock split is in the best interests of the Company and its stockholders. |
Organization and Significant _2
Organization and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Unaudited Interim Condensed Consolidated Financial Statements | The accompanying condensed 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”). The December 31, 2020 year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. Additionally, the Company’s independent registered public accounting firm report for the December 31, 2020 financial statements included an explanatory paragraph indicating that there is substantial doubt about the Company’s ability to continue as a going concern. Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements and the related footnote disclosures are unaudited. These unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the Securities and Exchange Commission’s (“SEC”) Rule 10-01 of Regulation S-X for interim financial information. The condensed consolidated financial statements were prepared on the same basis as the audited consolidated financial statements and in the opinion of management, reflect all adjustments of a normal, recurring nature that are necessary for the fair statement of the Company’s financial position and its results of operations and cash flows. The results of operations for interim periods are not necessarily indicative of the results expected for the full fiscal year or any future |
Basis of Consolidation | Basis of Consolidation The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Liquidity and Ability to Continue as a Going Concern | Liquidity and Ability to Continue as a Going Concern The Company’s condensed 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 condensed 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 March 31, 2021, the Company had an accumulated deficit of $258,229. • As of March 31, 2021, the Company had a total cash and cash equivalents balance of $32,661. • 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 three months ended March 31, 2021, the Company received aggregate net proceeds of $6,334 from the July 2020 Aspire CSPA and, as of March 31, 2021, had $12,005 in remaining availability for sales of its common stock under the July 2020 Aspire CSPA. • As described in Note 10—Stockholders’ Equity (Deficit), in early March 2020 the Company completed a public offering of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and common warrants to purchase common stock pursuant to the Company’s then effective shelf registration statement (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. The Company has also received proceeds from the exercise of common warrants issued in the March 2020 Public Offering of approximately $5,557 through March 31, 2021. • As described in Note 10—Stockholders’ Equity (Deficit), in late March 2020 the Company completed a registered direct offering of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) pursuant to the Company’s then-effective shelf registration statement (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. • 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 potentially begins commercialization activities. • The Company has concluded that the prevailing conditions and ongoing liquidity risks faced by the Company, coupled with uncertainty regarding the top-line efficacy results expected in the pivotal Phase 3 trial for SB206 as a treatment for molluscum contagiosum (“molluscum”, and such trial, the “B-SIMPLE4 Phase 3 trial”), which are currently targeted before the end of the second quarter of 2021, raise substantial doubt about its ability to continue as a going concern. The 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. The Company believes that its existing cash and cash equivalents balance as of March 31, 2021, plus expected contractual payments to be received in connection with existing licensing agreements, will provide it with adequate liquidity to fund its planned operating needs into the first quarter of 2022. This operating forecast and related cash projection includes: (i) costs through the expected completion of the B-SIMPLE4 Phase 3 trial, including supporting activities; (ii) preparatory costs associated with the anticipated continued regulatory progression of SB206; (iii) development activities in certain priority therapeutic areas, including infectious disease ( Coronaviridae (COVID-19)) and companion animal health; (iv) conducting drug manufacturing capability transfer activities to external third-party contract manufacturing organizations (“CMOs”), including a drug delivery device technology enhancement project; and (v) certain build-out and manufacturing capability costs related to the infrastructure necessary to support small-scale drug substance and drug product manufacturing at its new corporate headquarters, but excludes any potential costs associated with other late-stage clinical development programs and 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, the impact of outside factors such as the COVID-19 pandemic, its ability to enter into strategic arrangements, its ability to access additional capital and its financial priorities. The Company will need significant additional funding to continue its operating activities and make further advancements in its product development programs beyond those currently included in its operating forecast and related cash projection. The Company does not currently have sufficient funds to complete development and commercialization of any of its product candidates. 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 needs and intends to 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 equity issuances during the year ended December 31, 2020, and the three months ended March 31, 2021, have resulted in significant dilution to its existing stockholders. Any future additional issuances of equity, or debt that could be convertible into equity, would result in further significant dilution to the Company’s existing stockholders. As of March 31, 2021 the Company had 151,653,150 shares of common stock outstanding. In addition, as of March 31, 2021, the Company had reserved 15,856,608 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, 2020, the Company had 145,700,091 shares of its common stock outstanding, with an additional 16,903,031 reserved for future issuance. The Company’s common stock consists of 200,000,000 authorized shares as of March 31, 2021 and December 31, 2020. At the Annual Meeting held on May 4, 2021, the Company’s stockholders did not approve the proposal to amend the Company’s restated certificate of incorporation to increase the total number of authorized shares of its common stock from 200,000,000 to 250,000,000 shares. Because the Company’s stockholders did not approve an increase in authorized shares, without implementing a potential reverse stock split that would reduce the number of outstanding shares of its common stock and thereby increase the shares available for issuance, the Company may not have the ability to raise additional capital as needed to support development, regulatory approval and potential commercialization of its product candidates. See Note 14—Subsequent Events regarding the Annual Meeting held on May 4, 2021 and the proposal to amend the Company’s restated certificate of incorporation to increase the number of authorized shares of the Company’s common stock. Rather than raising additional capital, or if the Company is unable to raise additional capital on terms acceptable to the Company or at all, the Company may seek to engage in one or more potential transactions, such as the sale of the Company, or sale or divestiture of some of its assets, such as a sale of its dermatology platform assets, but there can be no assurance that the Company will be able to enter into such a transaction or transactions on a timely basis or at all on terms that are favorable to the Company. Under these circumstances, the Company 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. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders 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. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are anti-dilutive for all periods presented. |
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 Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 condensed 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 adoption of this new accounting guidance did not have a material impact on the Company’s condensed consolidated financial statements. |
Leases | 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. |
Share-based Compensation | ASC 718 requires that a liability-based award should be classified as a liability on the Company’s accompanying condensed 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 condensed 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 condensed 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. |
Organization and Significant _3
Organization and Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
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 three months ended March 31, 2021 and March 31, 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. March 31, 2021 2020 Warrants to purchase common stock (Note 10) 12,780,756 22,636,432 Stock options outstanding under the 2008 and 2016 Plans (Note 11) 1,922,522 2,010,603 Stock appreciation rights outstanding under the 2016 Plan (Note 11) 610,000 600,000 Inducement stock options outstanding (Note 11) 62,503 96,167 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 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 March 31, 2021 $ 4,500 $ 15,324 $ 10,824 Short-term Deferred Revenue Long-term Deferred Revenue Net Deferred Revenue December 31, 2020 $ 2,990 $ 8,238 $ 11,228 March 31, 2021 $ 2,990 $ 7,834 $ 10,824 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Components of Property and Equipment | Property and equipment consisted of the following: March 31, 2021 December 31, 2020 Computer equipment $ 67 $ 67 Furniture and fixtures 34 34 Laboratory equipment 3,210 2,930 Office equipment 137 72 Leasehold improvements 1,362 562 Property and equipment, gross 4,810 3,665 Less: Accumulated depreciation and amortization (1,317) (1,259) Total property and equipment, net $ 3,493 $ 2,406 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments | Future net minimum lease payments as of March 31, 2021 were as follows: Maturity of Lease Liabilities Operating Lease 2021 $ (1,991) 2022 481 2023 496 2024 511 2025 526 2026 and beyond 3,451 Total future undiscounted lease payments $ 3,474 Add: reclassification of discounted net cash inflows to other current assets $ 1,637 Less: imputed interest $ (1,991) Total reported lease liability $ 3,120 |
Components of Lease Assets and Liabilities | Components of lease assets and liabilities as of March 31, 2021 were as follows: As of March 31, 2021 Leases Assets Other current asset related to leasing arrangement, net $ 1,637 Right-of-use lease assets 1,444 Total assets $ 3,081 Liabilities Other long-term liabilities - operating lease $ 3,120 Total lease liabilities $ 3,120 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Schedule of Reserved Shares of Common Stock for Future Issuance | The following table presents outstanding warrants to purchase the Company’s common stock for the periods indicated. March 31, 2021 December 31, 2020 Exercise Warrants to purchase common stock issued in the January 2018 Offering 10,000,000 10,000,000 $ 4.66 Warrants to purchase common stock issued in the March 2020 Public Offering 2,561,667 2,624,167 0.30 Underwriter warrants to purchase common stock associated with the March 2020 Public Offering 113,042 594,958 0.375 Placement agent warrants to purchase common stock issued in the March 2020 Registered Direct Offering 106,047 558,140 0.5375 12,780,756 13,777,265 The Company had reserved shares of common stock for future issuance as follows: March 31, 2021 December 31, 2020 Outstanding warrants to purchase common stock 12,780,756 13,777,265 Outstanding stock options (Note 11) 1,985,025 1,991,964 Outstanding stock appreciation rights (Note 11) 610,000 610,000 For possible future issuance under the 2016 Stock Plan (Note 11) 480,827 523,802 15,856,608 16,903,031 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expenses | Total stock-based compensation expense included in the accompanying condensed consolidated statements of operations and comprehensive loss is as follows: Three Months Ended March 31, 2021 2020 Research and development $ (52) $ 208 General and administrative 132 64 Total $ 80 $ 272 |
Summary of Stock Option Activity | Stock option activity for the three months ended March 31, 2021 is as follows: Shares Weighted- Weighted- Aggregate Options outstanding as of December 31, 2020 1,991,964 $ 3.07 Options granted 88,970 1.66 Options forfeited (70,992) 4.25 Options exercised (24,917) 0.51 Options outstanding as of March 31, 2021 1,985,025 $ 3.00 7.05 $ 543 |
Organization and Significant _4
Organization and Significant Accounting Policies - Additional Information (Details) | Jul. 21, 2020USD ($) | Mar. 26, 2020USD ($) | Mar. 03, 2020USD ($) | Mar. 31, 2021USD ($)segment | Mar. 31, 2020USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Organization And Significant Accounting Policies [Line Items] | |||||||
Accumulated deficit | $ (258,229,000) | $ (258,229,000) | $ (249,277,000) | ||||
Cash and cash equivalents | 32,661,000 | $ 21,785,000 | 32,661,000 | 35,879,000 | |||
Proceeds from sale of common stock | 6,334,000 | 442,000 | |||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | 0 | 12,577,000 | |||||
Proceeds from exercise of common stock warrants | $ 442,000 | $ 2,880,000 | |||||
Reclassification of prepaid expenses and other current assets | $ 58,000 | ||||||
Number of segments | segment | 1 | ||||||
Percentage of total revenue generated from Japan licensing partner | 91.00% | 84.00% | |||||
License and collaboration revenue | |||||||
Organization And Significant Accounting Policies [Line Items] | |||||||
Revenue | $ 747,000 | $ 1,024,000 | |||||
License and collaboration revenue | Amended Sato Agreement | |||||||
Organization And Significant Accounting Policies [Line Items] | |||||||
Revenue | 747,000 | $ 1,024,000 | |||||
March 2020 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 | $ 5,158,000 | ||||||
Underwriting discounts and commissions and offering expenses | $ 791,000 | ||||||
March 2020 Registered Direct Offering | |||||||
Organization And Significant Accounting Policies [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 | ||||||
Aspire Capital | July 2020 Common Stock Purchase Agreement | |||||||
Organization And Significant Accounting Policies [Line Items] | |||||||
Proceeds from sale of common stock | $ 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 - Summary of Anti-dilutive Securities Excluded from Calculation of Weighted Average Common Shares Outstanding (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Warrants to Purchase Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 12,780,756 | 22,636,432 |
Stock Options | 2008 Stock Plan and 2016 Stock Plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 1,922,522 | 2,010,603 |
Stock Options | Inducement Options Outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 62,503 | 96,167 |
Stock Appreciation Rights (SARs) | 2016 Stock Plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 610,000 | 600,000 |
KNOW Bio, LLC (Details)
KNOW Bio, LLC (Details) - USD ($) | Oct. 13, 2017 | Dec. 29, 2015 | Mar. 31, 2021 | Mar. 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 | ||||
Right to sublicense, term | 3 years | ||||
Upfront license agreement payment due upon execution | $ 250,000 |
Research and Development Lice_2
Research and Development Licenses (Details) - USD ($) | Mar. 31, 2021 | Jun. 27, 2012 |
Licensing Agreements | ||
Research And Development Licenses [Line Items] | ||
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 ($) | Jan. 12, 2017JPY (¥) | Jan. 12, 2017USD ($) | Mar. 31, 2021 | Dec. 31, 2020JPY (¥) | Dec. 31, 2020USD ($) | Sep. 13, 2019JPY (¥) | Feb. 14, 2019JPY (¥) | Oct. 05, 2018JPY (¥) | Jan. 12, 2017USD ($) |
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 | ¥ 1,250,000,000 | $ 10,813,000 | ||||||||
Aggregate development and regulatory milestone payments potentially receivable under license agreement | 2,750,000,000 | 1,750,000,000 | ||||||||||||||||
Aggregate Phase 1 trial milestone payment term under license agreement | 250,000,000 | ¥ 250,000,000 | $ 2,162,000 | $ 2,162,000 | ||||||||||||||
Aggregate becoming payable upon earlier of specified future dates or achievement of milestone events | 1,000,000,000 | |||||||||||||||||
Aggregate commercial milestone payments potentially receivable under license agreement | ¥ 900,000,000 | ¥ 3,900,000,000 | ||||||||||||||||
License agreement additional term | 2 years | |||||||||||||||||
Maximum preclinical studies amount | $ | $ 1,000,000 | |||||||||||||||||
Written notice to terminate, period | 120 days | 120 days | ||||||||||||||||
Written notice to terminate due to material breach, term | 60 days | 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 ($) | Oct. 23, 2018JPY (¥) | Jan. 19, 2017USD ($) | Jan. 19, 2017JPY (¥) | Jan. 12, 2017USD ($) | Jan. 12, 2017JPY (¥) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020 | Mar. 31, 2020USD ($) | Dec. 31, 2020JPY (¥) | Feb. 29, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 13, 2019JPY (¥) | Aug. 30, 2019USD ($) | Feb. 14, 2019JPY (¥) | Oct. 05, 2018JPY (¥) | Jan. 12, 2017JPY (¥) |
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Amount of unconditional right to receive consideration | $ 4,500,000 | $ 4,843,000 | ||||||||||||||||||||
Foreign currency adjustments | $ 669,000 | $ 0 | ||||||||||||||||||||
Extension of estimated performance period | 1 year 9 months | |||||||||||||||||||||
Estimated performance period | 9 years 3 months | 7 years 6 months | ||||||||||||||||||||
Performance obligations under long-term contracts unsatisfied | $ 10,824,000 | |||||||||||||||||||||
License and collaboration revenue | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Revenue | 747,000 | 1,024,000 | ||||||||||||||||||||
Government research contracts and grants revenue | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Revenue | 72,000 | 189,000 | ||||||||||||||||||||
National Institutes of Health | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Revenue | 24,000 | |||||||||||||||||||||
National Institutes of Health | Phase 1 Grant | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Amount awarded from government grant | $ 223,000 | |||||||||||||||||||||
National Institutes of Health | Phase 2 Grant | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Amount awarded from government grant | $ 997,000 | |||||||||||||||||||||
National Institutes of Health | Government research contracts and grants revenue | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Revenue | 62,000 | |||||||||||||||||||||
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] | ||||||||||||||||||||||
Revenue | 10,000 | 165,000 | ||||||||||||||||||||
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 | 10,813,000 | ¥ 1,250,000,000 | ||||||||||||
Milestone payment received following initiation of Phase 1 trial | $ 2,162,000 | $ 2,162,000 | ¥ 250,000,000 | ¥ 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 | |||||||||||||||||||||
Potential future sales-based milestone payments | ¥ | ¥ 3,900,000,000 | ¥ 900,000,000 | ||||||||||||||||||||
Amended Sato Agreement | Other Nonoperating Income (Expense) | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Foreign currency adjustments | 686,000 | |||||||||||||||||||||
Amended Sato Agreement | License and collaboration revenue | ||||||||||||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||||||||||||
Revenue | $ 747,000 | $ 1,024,000 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Contract Balances (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Revenue from Contract with Customer [Abstract] | ||
Contract asset | $ 4,500 | $ 4,843 |
Contract liability, gross | 15,324 | 16,071 |
Net deferred revenue | 10,824 | 11,228 |
Deferred revenue, current portion | 2,990 | 2,990 |
Deferred revenue, net of current portion | $ 7,834 | $ 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]: 2021-04-01 | Mar. 31, 2021 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Revenue remaining performance obligation percentage | 20.00% |
Estimated performance period | 12 months |
Research and Development Arra_2
Research and Development Arrangements (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2021 | Mar. 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 | Ligand Pharmaceuticals Incorporated | ||||
Collaborative Arrangements Transactions [Line Items] | ||||
Research and development contra expense | $ (18,000) | $ (1,513,000) | ||
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] | ||||
Beneficial ownership percentage | 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 | Mar. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,810 | $ 3,665 |
Less: Accumulated depreciation and amortization | (1,317) | (1,259) |
Total property and equipment, net | 3,493 | 2,406 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 67 | 67 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 34 | 34 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,210 | 2,930 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 137 | 72 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,362 | $ 562 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation and amortization expense | $ 57 | $ 495 | |
Construction in process payable | 540 | $ 365 | |
Disposal group, held-for-sale | |||
Property, Plant and Equipment [Line Items] | |||
Carrying value of disposal group | $ 114 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | Mar. 18, 2021USD ($)ft² | Jan. 18, 2021USD ($)$ / ft² | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 01, 2020ft² | Jul. 16, 2020ft² | Aug. 31, 2015ft² |
Commitments And Contingencies [Line Items] | |||||||||
Square footage of leased space (in square feet) | ft² | 51,000 | ||||||||
Rent expense associated with facility leases | $ 145 | $ 224 | |||||||
Weighed average remaining lease term, operating leases | 10 years 9 months | ||||||||
Weighted average discount rate, operating lease liabilities | 8.35% | ||||||||
Other current asset related to leasing arrangement, net | $ 1,637 | $ 0 | |||||||
Forecast | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Tenant improvement allowance | $ 2,031 | ||||||||
February 2020 Restructuring | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Employee severance costs expensed | $ 59 | ||||||||
Hopson Road Facility Lease | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Square footage of leased space (in square feet) | ft² | 10,000 | 12,000 | |||||||
TBC Lease | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Square footage of leased space (in square feet) | ft² | 15,623 | ||||||||
Payment period after commencement date | 9 months | ||||||||
Optional term of extending lease agreement | 5 years | ||||||||
Monthly base rent | $ 40 | ||||||||
Monthly rent increase (as a percent) | 3.00% | ||||||||
Free rent period | 3 months | ||||||||
TBC Lease | Letter of Credit | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Letter of credit | $ 472 | ||||||||
TBC Lease | Maximum | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Tenant improvement allowance, amount per square foot | $ / ft² | 130 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Lease Payments (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 | $ (1,991) |
2022 | 481 |
2023 | 496 |
2024 | 511 |
2025 | 526 |
2026 and beyond | 3,451 |
Total future undiscounted lease payments | 3,474 |
Add: reclassification of discounted net cash inflows to other current assets | 1,637 |
Less: imputed interest | (1,991) |
Total reported lease liability | $ 3,120 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of Lease Assets and Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Assets | ||
Other current asset related to leasing arrangement, net | $ 1,637 | $ 0 |
Right-of-use lease assets | 1,444 | 0 |
Total assets | 3,081 | |
Operating Lease, Liability [Abstract] | ||
Other long-term liabilities - operating lease | 3,120 | $ 0 |
Total reported lease liability | $ 3,120 |
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) - USD ($) | Jul. 21, 2020 | Mar. 26, 2020 | Mar. 03, 2020 | Jan. 09, 2018 | Jul. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2020 | Mar. 31, 2021 | Dec. 31, 2019 |
Class of Stock [Line Items] | ||||||||||||
Capital stock, shares authorized (in shares) | 210,000,000 | 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) | $ 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) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||
Common stock issued during period (in shares) | 10,550,000 | 14,000,000 | ||||||||||
Period of option to purchase additional shares | 30 days | |||||||||||
Common stock, maximum additional shares available for purchase (in shares) | 2,750,000 | |||||||||||
Maximum additional number of common warrants available for purchase (in shares) | 2,750,000 | |||||||||||
Percentage of common stock sold related to warrants issued | 3.00% | 3.00% | ||||||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ 0 | $ 12,577,000 | ||||||||||
Warrants expiration period | 4 years | |||||||||||
Proceeds from exercise of common stock warrants | 442,000 | 2,880,000 | ||||||||||
Proceeds from issuance of common stock under common stock purchase agreement | $ 6,334,000 | $ 442,000 | ||||||||||
Common stock, shares outstanding (in shares) | 151,653,150 | 151,653,150 | 145,700,091 | 145,700,091 | 151,653,150 | |||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | |||||||
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 | |||||||||||
March 2020 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) | 10,000,000 | |||||||||||
Price per share (in USD per share) | $ 3.80 | |||||||||||
Warrant exercise price (in USD per share) | $ 4.66 | |||||||||||
Warrants exercised during period (in shares) | 0 | 0 | ||||||||||
Aspire Capital | July 2020 Common Stock Purchase Agreement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock issued during period (in shares) | 5,555,555 | 4,931,633 | 22,210,397 | |||||||||
Maximum value of shares of common stock authorized to be sold | $ 30,000,000 | |||||||||||
Common stock purchase agreement term | 30 months | |||||||||||
Shares of common stock issued for commitment fee (in shares) | 1,000,000 | |||||||||||
Value of commitment fee shares issued | $ 847,000 | |||||||||||
Maximum shares to be purchased with purchase notice per business day (in shares) | 300,000 | |||||||||||
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) | 2,000,000 | |||||||||||
Number of shares submitted via purchase notice to trigger a VWAP purchase notice (in shares) | 300,000 | |||||||||||
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) | $ 0.15 | |||||||||||
Maximum number of shares that may be sold under agreement (in shares) | 25,433,642 | |||||||||||
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) | $ 0.5907 | |||||||||||
Average sales price per share of common stock (in usd per share) | $ 1.28 | $ 0.81 | ||||||||||
Closing sale price of common stock (in usd per share) | $ 0.90 | |||||||||||
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 | $ 12,005,000 | |||||||||
Maximum | January 2018 Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants issued (in shares) | 10,000,000 | |||||||||||
Pre Funded Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants issued (in shares) | 8,054,652 | 4,333,334 | ||||||||||
Price per share (in USD per share) | $ 0.4299 | |||||||||||
Warrant exercise price (in USD per share) | 0.0001 | $ 0.0001 | ||||||||||
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 | March 2020 Registered Direct Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants owned (in shares) | 0 | 0 | 0 | |||||||||
Warrants exercised during period (in shares) | 4,602,326 | 8,054,652 | ||||||||||
Common Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants issued (in shares) | 2,750,000 | |||||||||||
Warrant exercise price (in USD per share) | $ 0.30 | |||||||||||
Warrants owned (in shares) | 2,561,667 | 2,561,667 | 2,561,667 | |||||||||
Warrants expiration period | 5 years | |||||||||||
Warrants exercised during period (in shares) | 62,500 | 18,521,667 | ||||||||||
Common Warrant | March 2020 Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Proceeds from exercise of common stock warrants | $ 18,000 | $ 5,557,000 | ||||||||||
Common Warrant | Maximum | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants issued (in shares) | 18,333,334 | |||||||||||
Pre Funded and Common Stock Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Price per share (in USD per share) | $ 0.2999 | |||||||||||
Underwriter Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants issued (in shares) | 594,958 | |||||||||||
Warrant exercise price (in USD per share) | $ 0.375 | |||||||||||
Warrants owned (in shares) | 113,042 | 113,042 | 113,042 | |||||||||
Warrants expiration period | 5 years | |||||||||||
Warrants exercised during period (in shares) | 481,916 | 0 | ||||||||||
Underwriter Warrant | March 2020 Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Proceeds from exercise of common stock warrants | $ 181,000 | |||||||||||
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) | $ 0.5375 | |||||||||||
Warrants owned (in shares) | 106,047 | 106,047 | 106,047 | |||||||||
Warrants expiration period | 5 years | |||||||||||
Warrants exercised during period (in shares) | 452,093 | 0 | ||||||||||
Proceeds from exercise of common stock warrants | $ 243,000 | |||||||||||
Placement Agent Warrant | Maximum | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants issued (in shares) | 558,140 | |||||||||||
Common Stock | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock issued during period (in shares) | 1,498,602 | |||||||||||
Price per share (in USD per share) | $ 0.43 | |||||||||||
Common stock, shares outstanding (in shares) | 151,653,150 | 72,019,062 | 151,653,150 | 145,700,091 | 145,700,091 | 151,653,150 | 26,734,800 | |||||
Common Stock | Pre Funded Warrant | March 2020 Registered Direct Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock issued during period (in shares) | 10,550,000 | |||||||||||
Common Stock | Common Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Price per share (in USD per share) | $ 0.30 | |||||||||||
Warrants to Purchase Common Stock | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants owned (in shares) | 12,780,756 | 12,780,756 | 13,777,265 | 13,777,265 | 12,780,756 | |||||||
Weighted average exercise price per share (in USD per share) | $ 3.71 | $ 3.71 | $ 3.48 | $ 3.48 | $ 3.71 | |||||||
Warrants to Purchase Common Stock | Common Warrant | March 2020 Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrant exercise price (in USD per share) | $ 0.30 | $ 0.30 | $ 0.30 | $ 0.30 | $ 0.30 | |||||||
Warrants owned (in shares) | 2,561,667 | 2,561,667 | 2,624,167 | 2,624,167 | 2,561,667 | |||||||
Warrants to Purchase Common Stock | Common Warrant | January 2018 Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrant exercise price (in USD per share) | $ 4.66 | $ 4.66 | $ 4.66 | $ 4.66 | $ 4.66 | |||||||
Warrants owned (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||
Warrants to Purchase Common Stock | Underwriter Warrant | March 2020 Registered Direct Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrant exercise price (in USD per share) | $ 0.375 | $ 0.375 | $ 0.375 | $ 0.375 | $ 0.375 | |||||||
Warrants owned (in shares) | 113,042 | 113,042 | 594,958 | 594,958 | 113,042 | |||||||
Warrants to Purchase Common Stock | Placement Agent Warrant | March 2020 Registered Direct Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrant exercise price (in USD per share) | $ 0.5375 | $ 0.5375 | $ 0.5375 | $ 0.5375 | $ 0.5375 | |||||||
Warrants owned (in shares) | 106,047 | 106,047 | 558,140 | 558,140 | 106,047 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Schedule of Outstanding Warrants to Purchase Common Stock (Details) - $ / shares | Mar. 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) | $ 4.66 | ||||
Warrants to Purchase Common Stock | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 12,780,756 | 13,777,265 | |||
Common Warrant | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 2,561,667 | ||||
Warrant exercise price (in USD per share) | $ 0.30 | ||||
Common Warrant | Warrants to Purchase Common Stock | January 2018 Public Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 10,000,000 | 10,000,000 | |||
Warrant exercise price (in USD per share) | $ 4.66 | $ 4.66 | |||
Common Warrant | Warrants to Purchase Common Stock | March 2020 Public Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 2,561,667 | 2,624,167 | |||
Warrant exercise price (in USD per share) | $ 0.30 | $ 0.30 | |||
Underwriter Warrant | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 113,042 | ||||
Warrant exercise price (in USD per share) | $ 0.375 | ||||
Underwriter Warrant | Warrants to Purchase Common Stock | March 2020 Registered Direct Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 113,042 | 594,958 | |||
Warrant exercise price (in USD per share) | $ 0.375 | $ 0.375 | |||
Placement Agent Warrant | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 106,047 | ||||
Warrant exercise price (in USD per share) | $ 0.5375 | ||||
Placement Agent Warrant | Warrants to Purchase Common Stock | March 2020 Registered Direct Offering | |||||
Class of Stock [Line Items] | |||||
Warrants owned (in shares) | 106,047 | 558,140 | |||
Warrant exercise price (in USD per share) | $ 0.5375 | $ 0.5375 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) - Schedule of Reserved Shares of Common Stock for Future Issuance (Details) - shares | Mar. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 15,856,608 | 16,903,031 |
2016 Stock Plan | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 480,827 | 523,802 |
Outstanding stock options | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 1,985,025 | 1,991,964 |
Stock Appreciation Rights (SARs) | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 610,000 | 610,000 |
Warrants to Purchase Common Stock | ||
Class of Stock [Line Items] | ||
Common stock shares reserved for future issuance (in shares) | 12,780,756 | 13,777,265 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 18, 2020 | Jan. 06, 2020 | Jul. 31, 2019 | Jul. 30, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of SARs granted (in shares) | 10,000 | 600,000 | |||||
Term of SAR award | 10 years | 10 years | |||||
Stock appreciation rights outstanding (in shares) | 610,000 | ||||||
Number of stock appreciation rights exercisable (in shares) | 385,000 | ||||||
Stock-based compensation expense for equity-based awards | $ 80 | $ 272 | |||||
Stock options outstanding (in shares) | 1,985,025 | 1,991,964 | |||||
Stock Appreciation Rights (SARs) | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Exercise price (in USD per share) | $ 0.53 | $ 0.82 | |||||
Employee share-based compensation expense | $ 29 | $ 62 | |||||
2016 Stock Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Increase in number of shares of common stock reserved for issuance (in shares) | 1,000,000 | ||||||
Maximum aggregate shares to be awarded to one person (in shares) | 1,000,000 | 250,000 | |||||
Shares available for future issuance (in shares) | 480,827 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-based Compensation Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense for equity-based awards | $ 80 | $ 272 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense for equity-based awards | (52) | 208 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense for equity-based awards | $ 132 | $ 64 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Shares Subject to Outstanding Options | |
Options outstanding (in shares) | shares | 1,991,964 |
Options granted (in shares) | shares | 88,970 |
Options forfeited (in shares) | shares | (70,992) |
Options exercised (in shares) | shares | (24,917) |
Options outstanding (in shares) | shares | 1,985,025 |
Weighted-Average Exercise Price Per Share | |
Options outstanding (in USD per share) | $ / shares | $ 3.07 |
Options granted (in USD per share) | $ / shares | 1.66 |
Options forfeited (in USD per share) | $ / shares | 4.25 |
Options exercised (in USD per share) | $ / shares | 0.51 |
Options outstanding (in USD per share) | $ / shares | $ 3 |
Weighted- Average Remaining Contractual Term (in years) | |
Options outstanding | 7 years 18 days |
Aggregate Intrinsic Value | |
Options outstanding | $ | $ 543 |
Tangible Stockholder Return P_2
Tangible Stockholder Return Plan (Details) | Aug. 02, 2018USD ($)tranche$ / shares | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 80,000 | $ 272,000 | |
Performance Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Estimated dividend yield | 0.00% | ||
Stock-based compensation expense | $ 44,000 | $ (113,000) | |
Performance Plan | Executive Officer | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Bonus award payment term | 24 months | ||
Performance Plan | Employees And Consultants | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Bonus award payment term | 12 months | ||
Performance Plan | Deferred Bonus | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of tranches | tranche | 2 | ||
Number of consecutive trading days | 30 days | ||
Share price target, first tranche (in USD per share) | $ / shares | $ 11.17 | ||
Bonus pool, first tranche | $ 25,000,000 | ||
Share price target, second tranche (in USD per share) | $ / shares | $ 25.45 | ||
Bonus pools, second tranche | $ 50,000,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Thousands | Mar. 26, 2020 | Mar. 03, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Apr. 29, 2019 |
Related Party Transaction [Line Items] | |||||||
Common stock, number of shares held (in shares) | 151,653,150 | 145,700,091 | |||||
Common stock issued during period (in shares) | 10,550,000 | 14,000,000 | |||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ 0 | $ 12,577 | |||||
Pre Funded Warrant | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants issued (in shares) | 8,054,652 | 4,333,334 | |||||
Common Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Common stock, number of shares held (in shares) | 151,653,150 | 72,019,062 | 145,700,091 | 26,734,800 | |||
Common stock issued during period (in shares) | 1,498,602 | ||||||
Board Members | |||||||
Related Party Transaction [Line Items] | |||||||
Common stock, number of shares held (in shares) | 1,174,776 | 1,104,776 | |||||
Reedy Creek Investments LLC | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants owned (in shares) | 3,900,000 | 3,900,000 | |||||
Reedy Creek Investments LLC | Novan, Inc. | Minimum | |||||||
Related Party Transaction [Line Items] | |||||||
Beneficial ownership percentage | 5.00% | 5.00% | |||||
Sabby | |||||||
Related Party Transaction [Line Items] | |||||||
Common stock issued during period (in shares) | 6,200,000 | ||||||
Sabby | Pre Funded Warrant | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants issued (in shares) | 2,602,326 | ||||||
Sabby | Common Stock | Pre Funded Warrant | |||||||
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) | 1,000,000 | ||||||
Proceeds from issuance of common stock and pre-funded warrants, net of underwriting fees and commissions | $ 430 |
Subsequent Events - Narrative (
Subsequent Events - Narrative (Details) - shares | May 04, 2021 | Jul. 31, 2019 | Mar. 31, 2021 | Dec. 31, 2020 |
Subsequent Event [Line Items] | ||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | ||
Forecast | ||||
Subsequent Event [Line Items] | ||||
Common stock, shares authorized (in shares) | 250,000,000 | |||
2016 Stock Plan | ||||
Subsequent Event [Line Items] | ||||
Increase in number of shares of common stock reserved for issuance (in shares) | 1,000,000 | |||
Subsequent event | 2016 Stock Plan | ||||
Subsequent Event [Line Items] | ||||
Increase in number of shares of common stock reserved for issuance (in shares) | 15,000,000 |