Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 18, 2020 | Jun. 28, 2019 | |
Document and Entity Information | |||
Entity Registrant Name | AGILE THERAPEUTICS INC | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 52.1 | ||
Entity Common Stock, Shares Outstanding | 69,810,305 | ||
Entity Central Index Key | 0001261249 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 34,479 | $ 7,851 |
Prepaid expenses | 840 | 607 |
Total current assets | 35,319 | 8,458 |
Property and equipment, net | 14,044 | 13,916 |
Right of use and other assets | 177 | 18 |
Total assets | 49,540 | 22,392 |
Current liabilities: | ||
Accounts payable | 1,819 | 875 |
Accrued expenses | 1,804 | 1,343 |
Lease payable, current portion | 172 | |
Total current liabilities | 3,795 | 2,218 |
Total liabilities | 3,795 | 2,218 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity | ||
Common stock, $.0001 par value, 150,000,000 shares authorized, 69,810,305 and 34,377,329 issued and outstanding at December 31, 2019 and 2018, respectively | 7 | 3 |
Additional paid-in capital | 306,108 | 261,722 |
Accumulated deficit | (260,370) | (241,551) |
Total stockholders' equity | 45,745 | 20,174 |
Total liabilities and stockholders' equity | $ 49,540 | $ 22,392 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, issued (in shares) | 69,810,305 | 34,377,329 |
Common stock, outstanding (in shares) | 69,810,305 | 34,377,329 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating expenses: | |||
Research and development | $ 9,858 | $ 9,777 | $ 14,428 |
General and administrative | 9,000 | 8,739 | 12,383 |
Restructuring Charges | 0 | 1,019 | |
Total operating expenses | 18,858 | 19,535 | 26,811 |
Loss from operations | (18,858) | (19,535) | (26,811) |
Other income (expense) | |||
Interest income | 252 | 366 | 282 |
Interest expense | (1,116) | (1,918) | |
Change in fair value of warrants | 29 | 143 | |
Total other income (expense), net | 252 | (721) | (1,493) |
Loss before benefit from income taxes | (18,606) | (20,256) | (28,304) |
Benefit from income taxes | 477 | ||
Net loss | $ (18,606) | $ (19,779) | $ (28,304) |
Net loss per share (basic and diluted) (in dollars per share) | $ (0.38) | $ (0.58) | $ (0.91) |
Weighted-average common shares (basic and diluted) (in shares) | 49,432,487 | 34,315,931 | 30,940,831 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common StockPublic offering | Common StockPrivate Placement | Common StockAt-the-market sales | Common Stock | Additional Paid-in CapitalPublic offering | Additional Paid-in CapitalPrivate Placement | Additional Paid-in CapitalAt-the-market sales | Additional Paid-in Capital | Accumulated Deficit | Public offering | Private Placement | At-the-market sales | Total |
Balance at Dec. 31, 2016 | $ 3 | $ 235,754 | $ (193,468) | $ 42,289 | |||||||||
Balance (in shares) at Dec. 31, 2016 | 28,759,731 | ||||||||||||
Increase (decrease) in stockholders' equity | |||||||||||||
Share-based compensation - stock options and RSUs | 3,651 | 3,651 | |||||||||||
Issuance of common stock | $ 18,535 | $ 18,535 | |||||||||||
Issuance of common stock (in shares) | 5,333,334 | ||||||||||||
Vesting of RSUs (in shares) | 16,667 | ||||||||||||
Issuance of common stock upon exercise of options | 152 | 152 | |||||||||||
Issuance of common stock upon exercise of options (in shares) | 76,610 | ||||||||||||
Net loss | (28,304) | (28,304) | |||||||||||
Balance at Dec. 31, 2017 | $ 3 | 258,092 | (221,772) | 36,323 | |||||||||
Balance (in shares) at Dec. 31, 2017 | 34,186,342 | ||||||||||||
Increase (decrease) in stockholders' equity | |||||||||||||
Share-based compensation - stock options and RSUs | 3,630 | 3,630 | |||||||||||
Vesting of RSUs (in shares) | 190,987 | ||||||||||||
Net loss | (19,779) | (19,779) | |||||||||||
Balance at Dec. 31, 2018 | $ 3 | 261,722 | (241,551) | 20,174 | |||||||||
Balance (in shares) at Dec. 31, 2018 | 34,377,329 | ||||||||||||
Increase (decrease) in stockholders' equity | |||||||||||||
Adjustment to derivative liabilities upon adoption of ASU 2017-11 | 213 | (213) | |||||||||||
Share-based compensation - stock options and RSUs | 1,762 | 1,762 | |||||||||||
Issuance of common stock | $ 2 | $ 1 | $ 1 | $ 12,685 | $ 7,809 | $ 21,753 | $ 12,687 | $ 7,810 | $ 21,754 | ||||
Issuance of common stock (in shares) | 14,526,315 | 8,426,750 | 12,242,436 | ||||||||||
Vesting of RSUs (in shares) | 145,204 | ||||||||||||
Issuance of common stock upon exercise of options | 164 | 164 | |||||||||||
Issuance of common stock upon exercise of options (in shares) | 92,271 | ||||||||||||
Net loss | $ 0 | 0 | (18,606) | (18,606) | |||||||||
Balance at Dec. 31, 2019 | $ 7 | $ 306,108 | $ (260,370) | $ 45,745 | |||||||||
Balance (in shares) at Dec. 31, 2019 | 69,810,305 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||
Net loss | $ (18,606) | $ (19,779) | $ (28,304) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 18 | 23 | 23 |
Amortization | 145 | ||
Noncash stock based compensation | 1,762 | 3,630 | 3,651 |
Noncash interest | 282 | 667 | |
Change in fair value of warrants | (29) | (143) | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | (233) | 155 | 2,006 |
Accounts payable and accrued expenses | 1,377 | (1,177) | (2,460) |
Lease liability | (152) | ||
Net cash used in operating activities | (15,689) | (16,895) | (24,560) |
Cash flows from investing activities: | |||
Acquisition of property and equipment | (98) | (318) | (1,313) |
Net cash used in investing activities | (98) | (318) | (1,313) |
Cash flows from financing activities: | |||
Principal payments of long-term debt | (10,888) | (5,612) | |
Proceeds from exercise of stock options | 164 | 152 | |
Net cash provided by (used in) financing activities | 42,415 | (10,888) | 13,075 |
Net increase (decrease) in cash and cash equivalents | 26,628 | (28,101) | (12,798) |
Cash and cash equivalents, beginning of year | 7,851 | 35,952 | 48,750 |
Cash and cash equivalents, end of year | 34,479 | 7,851 | 35,952 |
Supplemental cash flow information | |||
Interest paid during the year | $ 1,370 | 1,295 | |
Non-cash transactions | |||
Property and equipment purchases included in accounts payable | 49 | 242 | |
At-the-market sales | |||
Cash flows from financing activities: | |||
Proceeds from sales or issuance of common stock, net of offering costs | $ 42,251 | $ 18,535 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Description of Business | |
Organization and Description of Business | 1. Organization and Description of Business Nature of Operations Agile Therapeutics, Inc. (“Agile" or the "Company") was incorporated in Delaware on December 22, 1997. Agile is a women's healthcare company dedicated to fulfilling the unmet health needs of today's women. The Company's activities since inception have consisted principally of raising capital and performing research and development, including development of the Company’s lead product candidate. The Company is headquartered in Princeton, New Jersey. The Company’s sole approved product, Twirla ® , also known as AG200-15, is a once-weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA in February 2020. Substantially all of the Company’s resources are currently dedicated to commercializing Twirla in the United States. The Company has not generated product revenue to date and is subject to a number of risks similar to those of other early stage companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the potential need to obtain additional capital necessary to fund the development of its products, competition from larger companies and compliance with the FDA and other government regulations. If the Company does not successfully commercialize any product candidates, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of December 31, 2019, the Company had an accumulated deficit of approximately $260 million. The Company expects to continue to incur net losses into the foreseeable future The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 9), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. Going Concern As of December 31, 2019, the Company had cash and cash equivalents of $34.5 million. Additionally, in February 2020, the Company entered into a Credit Agreement and Guaranty with Perceptive Credit Holdings III, LP, or the Perceptive Credit Agreement. A first tranche of $5.0 million was funded on execution of the Perceptive Credit Agreement. A second tranche of $15.0 million was funded as a result of the approval of Twirla by the FDA (see Note 15). The Company believes that its cash and cash equivalents as of December 31, 2019 along with the proceeds of the Perceptive Credit Agreement received by the date of this report will be sufficient to meet its projected operating requirements through the end of 2020. The Company will require additional capital to fund its operating needs beyond 2020, which primarily will include commercializing Twirla, and exploring the advancement of its existing pipeline and its possible expansion through business development activities. The Company anticipates it will continue to incur net losses for the foreseeable future and the Company's ability to continue operations beyond 2020 will depend on its ability to obtain additional capital, as to which no assurances can be given. There can be no assurance that any financing by the Company can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing, management has concluded that there is substantial doubt about the Company's ability to continue as a going concern through the 12 months following the date on which this Annual Report on Form 10-K is filed. The Company continues to analyze various alternatives, including strategic and refinancing alternatives, asset sales and mergers and acquisitions. The Company's future success depends on its ability to raise additional capital and/or implement the various strategic alternatives discussed above. The Company cannot be certain that these initiatives or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company's current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to complete the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities. The audited financial statements as of December 31, 2019 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures and/or execute on its business plan and successfully launch Twirla. The audited financial statements as of December 31, 2019 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Polices Basis of Presentation The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented. Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock‑based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates. Risks and Uncertainties While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed, or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations. Cash and Cash Equivalents The Company considers all highly‑liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments , disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3). Other financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short‑term nature. Property and Equipment Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight‑line, method over the estimated useful lives of the assets. Expenditures incurred after the fixed assets have been put into operation, such as repairs and maintenance, are charged to earnings in the period in which costs are incurred. Improvements and additions are capitalized in accordance with Company policy. Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment , the Company’s policy is to review long‑lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long‑lived assets as of December 31, 2019. Research and Development Expense Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel‑related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development . In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. Deferred Financing Costs Costs directly attributable to the Company’s term loan (see Note 8) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $0, $133 and $239 for the years ended December 31, 2019, 2018 and 2017, respectively. Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents. All cash and cash equivalents are held in business checking and money market accounts in United States financial institutions the balances of which exceed federally insured limits. The Company has not recognized any losses from credit risks on such accounts. The Company believes it is not exposed to significant credit risks on cash and cash equivalents. The Company has no financial instruments with off‑balance sheet risk of accounting loss. Warrants The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity . ASC 480 requires that a financial instrument, other than an outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using the Black-Scholes option-pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations. In connection with the completion of the Company's initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Warrants with non-standard anti-dilution provisions (referred to as down round protection) are classified as liabilities and re-measured each reporting period. On January 1, 2019, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11 Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception, which indicates that a down round feature no longer precludes equity classification when assessing whether an investment is indexed to an entity’s own stock. The Company used a modified retrospective approach to adoption, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. Warrants to purchase 62,505 shares of common stock at $6.00 per share expired on December 14, 2019, and none of these warrants are outstanding as of December 31, 2019. The warrants issued in connection with the Company's debt financing completed in February 2015 (see Note 8) are classified as a component of stockholders' equity. The value of such warrants was determined using the Black-Scholes option-pricing model. As of December 31, 2019, there were outstanding 180,274 warrants to purchase common stock at $5.89 per share related to this debt financing. These warrants expire on February 24, 2020. Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2019 that qualifies for either recognition or disclosure in the financial statements under this guidance. Stock‑Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting segment, which is the business of developing its transdermal patch for use in contraception. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the years ended December 31, 2019, 2018 and 2017, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2019 2018 2017 Common stock warrants 180,274 242,779 Unvested restricted stock units — 264,361 Common stock options 7,192,357 3,805,305 Total 7,372,631 4,312,445 Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures. In February 2016, the FASB issued ASU No. 2016-02, Leases . The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company adopted ASU No. 2016-02 on January 1, 2019. The Company recorded a lease asset and lease liability of approximately $0.3 million on its balance sheet as of January 1, 2019, with no impact on its statement of operations. In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. This ASU eliminates the requirement to consider “down round” features when determining whether certain equity-linked financial instruments or embedded features are indexed to an entity’s own stock. On January 1, 2019, the Company adopted the provisions of ASU No. 2017-11 using a modified retrospective approach, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. As a result of the adoption of ASU 2017-11, effective January 1, 2019, the Company no longer measures these warrants at fair value. In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting to provide clarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to change the terms or conditions of a share-based payment award. The amendments in this ASU provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This Update is the final version of Proposed ASU 2016-360—Compensation—Stock Compensation (Topic 718)—Scope of Modification Accounting, which has been deleted. The amendments in this ASU are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. The adoption of this ASU did not have a material impact on the Company's financial statements. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses rather than incurred losses to estimate credit losses on certain types of financial instruments, including trade receivables. ASU 2016-13 was adopted by the Company on January 1, 2020 and has no current impact on the Company as we do not have any financial instruments covered by the topic. Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements ASC 820, Fair Value Measurements and Disclosures , describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three‑level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: · Level 1—Quoted prices in active markets for identical assets and liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities. · Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities. · Level 3—Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participant price the fair value of the assets or liabilities. The Company has no Level 3 assets or liabilities. The following tables set forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of December 31, 2019 and 2018: Level 1 Level 2 Level 3 2019 Assets: Cash equivalents $ 34,444 $ — $ — Total assets at fair value $ 34,444 $ — $ — Level 1 Level 2 Level 3 2018 Assets: Cash equivalents $ 7,776 $ — $ — Total assets at fair value $ 7,776 $ — $ — The following is a roll forward of the fair value of Level 3 warrants: Beginning balance at December 31, 2016 $ 172 Change in fair value (143) Ending balance at December 31, 2017 29 Change in fair value (29) Ending balance at December 31, 2018 — Change in fair value — Ending balance at December 31, 2019 $ — There were no transfers between Level 1, 2 or 3 during 2019 or 2018. |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Prepaid Expenses | |
Prepaid Expenses | 4. Prepaid Expenses Prepaid expenses consist of the following: December 31, 2019 2018 Prepaid insurance $ 656 $ 484 Other 184 Total prepaid expenses $ 840 $ |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment | |
Property and Equipment | 5. Property and Equipment Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight‑line, method over the estimated useful lives of the assets. Property and equipment consist of the following: December 31, 2019 2018 Estimated Life Office equipment $ 49 $ 3 - 10 years Computer equipment 179 3 years Manufacturing equipment 14,203 5 years 14,431 Less: accumulated depreciation (387) Property and equipment $ 14,044 $ As of December 31, 2019, and 2018, manufacturing equipment includes approximately $14.0 million and $13.9 million, respectively, of equipment which is in the process of being constructed and qualified and is not currently being depreciated. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Liabilities | |
Accrued Liabilities | 6. Accrued Liabilities Accrued liabilities consist of the following: December 31, 2019 2018 Employee bonuses $ 1,437 $ Accrued retention bonus — Accrued professional fees and other 367 Total accrued liabilities $ 1,804 $ |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Leases | 7. Leases In February 2016, the FASB issued ASU No. 2016-02, Leases . The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The Company adopted ASU No. 2016-02 on January 1, 2019 for leases that existed on that date. The Company has elected to apply the provisions of ASC 842 modified retrospectively at January 1, 2019 through a cumulative-effect adjustment. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods. The company recorded a lease asset and lease liability of approximately $0.3 million on its balance sheet as of January 1, 2019, with no impact on its statement of operations. The Company has no finance leases and one operating lease for office space in Princeton, NJ. Operating lease expense was $193 for the year ended December 31, 2019. Operating cash flows used for operating leases during the year ended December 31, 2019 were $152. As of December 31, 2019, the weighted-average remaining lease term was 0.92 years and the weighted average discount rate was 21.2%. Future minimum lease payments under non-cancellable leases as of December 31, 2019 were as follows: 2020 $ 191 Total $ 191 Less: Interest (19) Present value of lease liability $ 172 |
Loan and Security Agreement
Loan and Security Agreement | 12 Months Ended |
Dec. 31, 2019 | |
Loan and Security Agreement | |
Loan and Security Agreement | 8. Loan and Security Agreement Hercules Capital, Inc. In February 2015, the Company entered into a loan and security agreement (the "Hercules Loan Agreement") with Hercules Capital, Inc. ("Hercules") for a term loan of up to $25.0 million. In August 2016, the Company entered into the First Amendment to Loan and Security Agreement (the "First Amendment") with Hercules which amended certain terms of the Hercules Loan Agreement. In May 2017, the Company entered into the Second Amendment to Loan and Security Agreement (the “Second Amendment”) with Hercules which further amended certain terms of the Hercules Loan Agreement. A first tranche of $16.5 million was funded upon execution of the Hercules Loan Agreement, approximately $15.5 million of which was used to repay the Company's previous term loan with Oxford Finance LLC. The First Amendment extended the Company's option to draw down the second tranche of $8.5 million (the "Second Term Loan Advance") of the term loan facility provided under the Hercules Loan Agreement (the "Term Loan") until March 31, 2017 and made the Second Term Loan Advance subject to the consent of Hercules, among other customary conditions. The Second Amendment further extended the Company's option to draw the Second Term Loan Advance until January 31, 2018 and continued to make the Second Term Loan Advance subject to the consent of Hercules, among other customary conditions. The First Amendment also extended the interest-only payments until January 31, 2017, in connection with the first tranche of $16.5 million (the "First Term Loan Advance" and together with the Second Term Loan Advance, the "Term Loan Advances"). The period during which the additional tranche of $8.5 million may be drawn has expired and therefore the $8.5 million can no longer be drawn by the Company. The First Amendment provided the Term Loan matured on December 1, 2018. As a result of the First Amendment, and in connection with the extension of the interest-only period from the First Term Loan Advance, Hercules returned to the Company the principal payments paid by the Company in July and August 2016, which such returned payments once again constituted outstanding Term Loan advances under the Hercules Loan Agreement. In connection with the execution of the First Amendment, the Company paid Hercules a facility fee of $165. The facility fee represented a debt issue cost which was reflected as a reduction to the carrying amount of the loan payable in accordance with ASU 2015-03. Such issue costs were amortized to interest expense over the life of the Term Loan using the effective interest method. As of December 31, 2019, and 2018, the Company had no outstanding borrowings related to the Hercules Loan Agreement. The Term Loan accrued interest at a rate of the greater of 9.0% or 9.0% plus Prime minus 4.25% and was payable monthly. Principal was due in 23 consecutive monthly installments beginning on February 1, 2017 and ending on December 1, 2018. In addition to the outstanding principal balance, the Company was required to make a final payment of approximately $611 on the maturity date of the Hercules Loan (December 1, 2018). The amount of the end of term final payment was accrued over the loan term as interest expense. The obligations of the Company under the Hercules Loan Agreement were secured by a perfected first position lien on all of the assets of the Company, excluding intellectual property assets. In connection with the Hercules Loan Agreement, the Company issued Hercules a warrant to purchase 180,274 shares of the Company’s common stock at an exercise price of $5.89 per share which expires on February 24, 2020 and granted Hercules the right to participate in future equity financings in an amount up to $2.0 million while the loan or warrant are outstanding. The Company allocated the proceeds of $16.5 million in accordance with ASC 470 based on the relative fair values. The relative fair value of the warrants of approximately $1.2 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the Company's warrant issued to Hercules include (i) volatility (75.0%), (ii) risk free interest rate of 1.22% (estimated using treasury bonds with a 4-year life), (iii) strike price ($5.89) for the common stock warrant, (iv) fair value of common stock ($9.82) and (v) expected life (4 years). The discount on the debt was amortized to interest expense over the term of the debt. Interest expense on the Hercules Loan Agreement including the accretion of the value of the related warrants, accrual of term loan back-end fee and amortization of the deferred financing costs was approximately $0, $1.1 million and $1.9 million, for the years ended December 31, 2019, 2018 and 2017, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | 9. Stockholders’ Equity The Company’s Certificate of Incorporation, among other things: (i) authorizes 150,000,000 shares of common stock; (ii) authorizes 10,000,000 shares of undesignated preferred stock that may be issued from time to time by the Board in one or more series; (iii) provides that the Board be divided into three classes with staggered three-year terms, with one class of directors to be elected at each annual meeting of the Company’s stockholders; (iv) provides that directors may only be removed with cause and only upon the affirmative vote of holders of at least 75% of the voting power of all then-outstanding shares of capital stock of the Company entitled to vote generally in the election of directors; (v) provides that only the Board, the chairman of the Board or the chief executive officer may call a special meeting of stockholders; and (vi) requires that any action instituted against the Company’s officers or directors in connection with their service to the Company be brought in the State of Delaware. Shelf Registration Statements On June 19, 2015, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $150.0 million (the "2015 Shelf Registration Statement"). On July 1, 2015, the 2015 Shelf Registration Statement was declared effective by the SEC. The Company completed an offering of common stock in both January 2016 and August 2017 utilizing the 2015 Shelf Registration Statement. The 2015 Shelf Registration Statement expired on June 30, 2018. On November 2, 2018, the Company filed a universal shelf registration statement with the Securities and Exchange Commission (“SEC”) for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $100.0 million (the "2018 Shelf Registration Statement"). On November 14, 2018, the 2018 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2018 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. On January 23, 2019, the Company filed a prospectus supplement to its 2018 Shelf Registration Statement registering an at-the-market offering program we entered into for the sale of up to $10.0 million of shares of our common stock. In the year ended December 31, 2019, the Company sold a total of 1,801,528 shares of our common stock under this ATM program resulting in net proceeds of approximately $2.5 million. We terminated this at-the-market offering program on July 31, 2019. In August 2019, the Company filed a prospectus supplement to its 2018 Shelf Registration Statement registering a public offering of 14,526,315 shares of common stock at a price of $0.95 per share. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses, were approximately $12.7 million. On November 8, 2019, the Company filed a prospectus supplement to its 2018 Shelf Registration Statement registering an at-the-market offering program we entered into for the sale of up to $20.0 million of shares of our common stock. In the year ended December 31, 2019, we sold a total of 10,440,908 shares of our common stock under this ATM program resulting in net proceeds of approximately $19.3 million. Private Placement In March 2019, the Company completed a private placement of 8,426,750 shares of common stock at $0.93 per share. Proceeds from the Company’s private placement, net of offering costs were approximately $7.8 million. 2016 Public Offering of Common Stock In January 2016, the Company completed an underwritten public offering of 5,511,812 shares of its common stock at a public offering price of $6.35 per share. In February 2016, the underwriters of the public offering of common stock exercised in full their option to purchase an additional 826,771 shares of common stock at the public offering price of $6.35 per share, less underwriting discounts and commissions. A total of 6,338,583 shares of common stock were sold in the public offering resulting in total net proceeds of approximately $37.5 million. One of the Company’s stockholders, who is also affiliated with a member of the Board, purchased 393,700 shares of common stock for approximately $2.5 million in the public offering. 2017 Public Offering of Common Stock In August 2017, the Company completed an underwritten public offering of 5,333,334 shares of its common stock at a public offering price of $3.75 per share. Proceeds from this offering, net of underwriting discounts, commissions and other offering costs were approximately $18.5 million. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2019 | |
Equity Incentive Plans | |
Equity Incentive Plans | 10. Equity Incentive Plans Stock options The Company had granted stock options under an amended and restated 1997 Equity Incentive Plan (the “1997 Plan”) and a 2008 Equity Incentive Plan (the “2008 Plan”). The plans provided for the granting of incentive and non-statutory options and stock awards to consultants, directors, officers and employees. Such options are exercisable for a period of ten years and generally vest over a four-year period. In conjunction with the adoption of the 2008 Plan in April 2008, no additional grants were made from the 1997 Plan and issued options from the 1997 Plan remain outstanding. In 2014, the Board approved the 2014 Equity Incentive Plan (the “2014 Plan”). The 2014 Plan is the successor to the Company’s 2008 Plan and 1997 Plan. In conjunction with the adoption of the 2014 Plan in 2014, no additional grants were made from the 2008 Plan and options from the 1997 Plan and the 2008 Plan remain outstanding. In June 2018, the 2014 Plan was amended and restated, and the Amended and Restated 2014 Incentive Compensation is now referred to as the Amended 2014 Plan. As of December 31, 2019, there were 2,170,175 shares available for future grant under the Amended 2014 Plan. Through December 31, 2019, the Company granted options to certain employees and nonemployees to purchase shares of common stock at exercise prices ranging from $0.58 to $10.75 per share. The Company recorded noncash stock-based compensation expense for the years ended December 31, 2019, 2018 and 2017 based on the fair market value of the options and shares granted at the grant date. Stock‑based compensation expense was as follows: Year Ended December 31, 2019 2018 2017 Research and development $ 522 $ $ 1,184 General and administrative 1,240 2,467 Total $ 1,762 $ $ 3,651 The following assumptions were used to compute employee stock‑based compensation under the Black‑Scholes option pricing model: 2019 2018 2017 Risk-free interest rate 1.74 % - 2.61 % 2.57 % 2.27 % Expective volatility 65.0 % 70.0 % 73.9 % Expected dividend yield 0 % 0 % 0 % Expected life (in years) 6.25 6.25 6.25 Risk‑free interest rate. The Company bases the risk‑free interest rate assumption on observed interest rates appropriate for the expected term of the stock option grants. Expected dividend yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends. Expected volatility. The expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on comparable companies in the biotechnology and pharmaceutical industries. Expected term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historic exercise behavior, management determined the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period. Forfeitures. The Company has elected to record forfeitures as they occur. As of December 31, 2019, the unrecorded deferred stock‑based compensation balance related to stock options was approximately $1.9 million and will be recognized over an estimated weighted‑average amortization period of 1.4 years. The weighted average grant date fair value of options granted during the year ended December 31, 2019 was $0.59. The following table summarizes the options outstanding, options vested and the options exercisable as of December 31, 2019, 2018 and 2017: Weighted Weighted Average Average Remaining Exercise Contractual Aggregate Options Price Life (Years) Intrinsic Value Options outstanding at December 31, 2017 3,805,305 5.74 7.4 Options granted 2,230,000 1.96 Options exercised — — Options cancelled/forfeited (347,404) 4.19 Options outstanding at December 31, 2018 5,687,901 4.34 7.4 Options granted 2,805,600 1.18 Options exercised (92,271) 1.78 Options cancelled/forfeited (1,208,873) 2.70 Options outstanding at December 31, 2019 7,192,357 3.42 7.2 $ 5,256 Options exercisable at December 31, 2019 4,396,577 4.60 6.1 $ 2,228 Vested and expected to vest at December 31, 2019 7,192,357 $ 5,256 Intrinsic value in the tables was calculated as the difference between the Company's stock price at December 31, 2019, of $2.50 per share, and the exercise price, multiplied by the number of options. Restricted Stock Units During the year ended December 31, 2016, the Company granted 50,000 RSUs to an employee of the Company, 16,666 RSUs vested on the grant date, 16,667 RSUs vested in February 2017 and the remaining 16,667 RSUs vested in February 2018. During the year ended December 31, 2017, the Company granted a total of 247,694 RSUs to executive officers and directors of the Company. These RSUs vested ratably over a two-year period for the executive officers and on the one-year anniversary of the grant date for the directors. During the year ended December 31, 2018, the Company granted a total of 108,254 RSUs to executive officers of the Company representing payment for 2017 target bonuses. These RSUs vested on the one-year anniversary of the grant date. The following table shows the Company's restricted stock unit activity during the years ended December 31, 2019, 2018 and 2017: Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2017 264,361 3.16 Granted 108,254 3.46 Vested (225,061) 3.39 $ 370 Restricted stock units outstanding at December 31, 2018 147,554 3.03 Vested (147,554) 3.03 $ 129 Restricted stock units outstanding at December 31, 2019 — Performance Based Restricted Stock Awards In addition to the RSUs detailed in the table above, during 2017 the Company granted up to 260,000 shares of performance-based restricted stock units (“Performance Units”) under the Company’s Amended 2014 Incentive Compensation Plan, to executive officers which are primarily contingent upon achievement of performance goals during the performance period beginning on the date of grant and ending on December 31, 2018 as set forth in each officer’s performance unit agreement. For awards with a performance condition which affects the vesting of the Performance Units, cost is recognized only if the performance condition is probable of being satisfied. Given the uncertainty of the achievement of the performance goals during the performance period, the Company did not record compensation expense related to these awards for the year ended December 31, 2017. These performance-based restricted stock units expired and were subsequently replaced with new awards in January 2018 (see below). In January 2018, the Company granted up to 365,000 shares of performance-based restricted stock units ("Performance Units") under the Company's 2014 Incentive Compensation Plan primarily to executive officers, which were largely contingent upon the achievement of performance goals during the performance period beginning on the date of grant and ending on December 31, 2019 as set forth in each individual's Performance Unit agreement. Performance Units granted in January 2018 replaced Performance Units granted in April 2017 which expired. During 2018, 50,000 Performance Units were cancelled and as of December 31, 2018 315,000 Performance Units remained outstanding. The remaining 315,000 Performance Units expired in December 2019 as the performance goals were not achieved, and there are no Performance Units outstanding as of December 31, 2019. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Income Taxes | 11. Income Taxes On December 22, 2017, the President of the United States signed into law an Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (commonly known as “the Tax Cuts and Jobs Act or the “TCJA””), which introduced a comprehensive set of tax reforms. The Tax Cuts and Jobs Act significantly revises U.S. tax law by, among other provisions, lowering the Company’s corporate tax rate from 34% to 21% and eliminating or reducing certain income tax deductions. In December 2017, in accordance with the SEC Staff Accounting Bulletin ("SAB") 118–Income Tax Accounting Implications of the TCJA, the Company recorded tax effects on a provisional basis based on a reasonable estimate. The TCJA did not have a material impact on the Company's financial statements because its deferred temporary differences are fully offset by a valuation allowance and the Company does not have any offshore earnings from which to record the mandatory transition tax. During 2018, the Company completed its analysis under SAB 118 and no additional tax effects due to rate-remeasurement were required to be recorded. As of December 31, 2019, the Company had available net operating loss carryforwards (“NOLs”) of approximately $231.5 million for federal and $92.4 million for state income tax reporting purposes. Under TCJA, the federal NOLs generated in 2019 and 2018, approximately $32.5 million, can be carried forward indefinitely, while the NOLs generated through taxable years ending December 31, 2017, approximately $198.9 million, are available to offset future federal taxable income, if any, through 2037. The Company also has research and development tax credit carryforwards of approximately $6.3 million and $1.6 million for federal and state income tax reporting purposes, respectively, which are available to reduce federal income taxes, if any, through 2039 and state income taxes, if any, through 2034. The Internal Revenue Code of 1986, as amended (the “Code”) provides for a limitation on the annual use of NOLs and other tax attributes (such as research and development tax credit carryforwards) following certain ownership changes, as defined by the Code that could significantly limit the Company’s ability to utilize these carryforwards. At this time, the Company has not completed a study to assess whether an ownership change under Section 382 of the Code has occurred, or whether there have been multiple ownership changes since the Company’s formation, due to the costs and complexities associated with such a study. The Company is likely to have experienced various ownership changes, as defined by the Code, as a result of past financings. Accordingly, the Company’s ability to utilize the aforementioned carryforwards may be limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes. Therefore, the Company may not be able to take full advantage of these carryforwards for federal and state income tax purposes. The Company does not have any significant unrecognized tax benefits. As of December 31, 2019, the Company has not accrued interest or penalties related to uncertain tax positions. The Company’s tax returns for the years ended December 31, 2016 through December 31, 2018 are still subject to examination by major tax jurisdictions. However, the Internal Revenue Service (“IRS”) and state tax jurisdictions can audit the NOLs generated in prior years in the years that those NOLs are utilized. For all years through December 31, 2019, the Company generated research credits but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment in known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance. The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are presented below: December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 55,216 $ Research credit carryforward 7,609 Stock options and other 3,225 Total gross deferred tax assets 66,050 Valuation allowance for deferred tax assets (66,050) Net deferred tax assets $ — $ — The net change in the valuation allowance for the years ended December 31, 2019 and 2018 was an increase of $5.3 million and an increase of $4.8 million, respectively. A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows: December 31, 2019 2018 2017 Federal income tax at statutory rate % % % State income tax benefit, net of federal benefit % % % Research and development tax credits % % % Effect of tax rate changes % % -94.0 % Other -4.0 % -4.0 % -1.0 % Decrease (increase) to valuation allowance -28.0 % -24.0 % % Effective income tax rate % % % Sale of New Jersey Net Operating Losses 2018 The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused NOLs and unused research and development credits to sell these benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation. In January 2018, the Company completed the sale of NOLs totaling approximately $0.5 million. This amount is a current state tax benefit and is reflected in the statement of operations for the year ended December 31, 2018. The Company has now reached the maximum lifetime benefit of $15.0 million under the Program and will no longer be eligible to participate in the Program. |
Restructuring Costs
Restructuring Costs | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring Costs | |
Restructuring Costs | 12. Restructuring Costs In June 2018, the Company announced a reduction in its workforce, which resulted in the termination of several employees primarily from the Company’s commercial and clinical teams, representing approximately thirty percent of its employees. This workforce reduction, along with other reductions in planned operating expenses is designed to preserve cash while the Company pursued formal dispute resolution with the FDA for Twirla and determines a regulatory path forward for the resubmission of the Company’s NDA for Twirla. In June 2018, the Company also announced that it had adopted a retention plan (the “Retention Plan”) to provide (i) cash retention payments to all remaining employees in order to induce such employees to remain employed by the Company through December 31, 2018 and (ii) stock option grants to all remaining employees in order to induce such employees to remain employed by the Company through December 31, 2019. Each employee who participated in the Retention Plan and (i) remained continuously employed by the Company through December 31, 2018 or (ii) was terminated by the Company other than for cause (as defined in an applicable employment agreement, or, if no employment agreement exists, as determined by the Company in good faith) prior to December 31, 2018, was paid a lump-sum cash payment in an amount determined by the compensation committee (“Compensation Committee”) of the Company’s board of directors at the time of the adoption of the Retention Plan. If an eligible employee terminated service prior to December 31, 2018 for any reason other than termination of employment by the Company without cause, no such cash retention payment was made to the eligible employee. The total amount of the cash portion of the Retention Plan was approximately $0.6 million. In addition, all remaining employees were granted a stock option to purchase the number of shares of common stock as approved by the Compensation Committee, with a per share exercise price of $0.58, representing the closing price of the Company’s common stock as reported by Nasdaq on the date the Retention Plan was approved by the Compensation Committee. Each option vested in four equal 25% installments on the following dates: (i) June 20, 2018, (ii) December 31, 2018, (iii) June 30, 2019 and (iv) December 31, 2019, subject to the employee's continuing service to the Company. A summary of accrued restructuring costs, included as a component of accrued liabilities on the Company’s unaudited December 31, 2019 balance sheet is as follows: December 31, 2018 Charges Payments December 31, 2019 Accrued retention bonus 638 — (638) — Total $ 638 $ — $ (638) $ — |
2019 Retention Plan
2019 Retention Plan | 12 Months Ended |
Dec. 31, 2019 | |
2019 Retention Plan | |
2019 Retention Plan | 13. 2019 Retention Plan In July 2019, the Company adopted a retention plan (the “2019 Retention Plan”) for all employees (with the exception of the Chairman and Chief Executive Officer) in order to induce such employees to remain employed by the Company through at least the PDUFA goal date of November 16, 2019. Each employee who participates in the 2019 Retention Plan and remains continuously employed by the Company through the Approval shall be paid a lump-sum cash payment in an amount determined for each eligible employee by the Compensation Committee at the time of the adoption of the 2019 Retention Plan. If an eligible employee terminates employment prior to the Approval for any reason, no such retention payment shall be made to the eligible employee. The total amount of the cash portion of the 2019 Retention Plan is approximately $0.3 million. Given that the PDUFA goal date was extended to February 16, 2020 and the ultimate uncertainty of the approval of Twirla, the Company has not recorded compensation expense related to these potential cash awards for the year ended December 31, 2019. All employees (with the exception of the Chairman and Chief Executive Officer) who were employed by the Company as of July 3, 2019 were also granted a stock option to purchase the number of shares of common stock as approved by the Compensation Committee, with a per share exercise price of $1.48, representing the closing price of the Company’s common stock as reported by Nasdaq on the date of grant. Each option will vest in two equal 50% installments on the following dates (i) July 3, 2020 and (ii) December 31, 2020. In addition, the vesting for the annual stock option grant in January 2019 were amended for all employees holding such options who were employed on July 3, 2019 as follows: 50% of the option will vest on January 29, 2020, 25% on June 30, 2020 and the remaining 25% on December 31, 2020. The change in vesting schedule was approved by the Compensation Committee and did not have a material impact on the Company’s statement of operations. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies | |
Commitments and Contingencies | 14. Commitments and Contingencies The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could have an adverse effect on the Company's operations or its financial position. As of December 31, 2019, the Company has not recorded a provision for any contingent losses. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Event | |
Subsequent Event | 15. Subsequent Event In February 2020, the Company entered into a Credit Agreement and Guaranty with Perceptive Credit Holdings III, LP, a related party, or Perceptive, for a senior secured term loan credit facility of up to $35 million, (the Perceptive Credit Agreement”). A first tranche of $5 million was funded on execution of the Perceptive Credit Agreement. A second tranche of $15 million was funded as a result of the approval of Twirla by the FDA. Another $15 million tranche will be available to the Company based on the achievement of certain revenue milestones. The facility will be interest only until the third anniversary of the closing date. As part of the Perceptive Credit Agreement, the Company issued Perceptive warrants to purchase 1,400,000 shares of Agile common stock. The per share exercise price for 700,000 shares is $3.74, which is equal to the 5-day volume weighted average exercise price ("5 Day VWAP") as of the trading day immediately prior to closing. The per share exercise price for the remaining 700,000 shares of Agile common stock is $4.67, which is 1.25 times the 5 Day VWAP. |
Quarterly Data (Unaudited)
Quarterly Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Data (Unaudited) | |
Quarterly Data (Unaudited) | 16. Quarterly Data (Unaudited) The following tables summarize the quarterly results of operations for each of the quarters in 2019 and 2018. These quarterly results are unaudited, but in the opinion of management, have been prepared on the same basis as our audited financial information and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information set forth herein (in thousands, except per share amounts). March 31, June 30, September 30, December 31, 2019 2019 2019 2019 Total revenue $ — $ — $ — $ — Operating expenses $ 4,707 $ 3,547 $ 4,499 $ 6,105 Net loss $ (4,669) $ (3,484) $ (4,432) $ (6,021) Basic and diluted net loss per common share $ (0.13) $ (0.08) $ (0.08) $ (0.10) March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Total revenue $ — $ — $ — $ — Operating expenses $ $ $ $ Net loss $ $ $ $ Basic and diluted net loss per common share $ (0.20) $ (0.16) $ (0.11) $ (0.11) The net loss and basic and diluted net loss per share for the quarter ended March 31, 2018 include a tax benefit of $0.5 million from the sale of New Jersey state NOLs. (see Note 11). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented. |
Use of Estimates | Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock‑based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates. |
Risks and Uncertainties | Risks and Uncertainties While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed, or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly‑liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments , disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3). Other financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short‑term nature. |
Property and Equipment | Property and Equipment Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight‑line, method over the estimated useful lives of the assets. Expenditures incurred after the fixed assets have been put into operation, such as repairs and maintenance, are charged to earnings in the period in which costs are incurred. Improvements and additions are capitalized in accordance with Company policy. |
Long-Lived Assets | Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment , the Company’s policy is to review long‑lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long‑lived assets as of December 31, 2019. |
Research and Development Expense | Research and Development Expense Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel‑related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development . In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. |
Deferred Financing Costs | Deferred Financing Costs Costs directly attributable to the Company’s term loan (see Note 8) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $0, $133 and $239 for the years ended December 31, 2019, 2018 and 2017, respectively. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents. All cash and cash equivalents are held in business checking and money market accounts in United States financial institutions the balances of which exceed federally insured limits. The Company has not recognized any losses from credit risks on such accounts. The Company believes it is not exposed to significant credit risks on cash and cash equivalents. The Company has no financial instruments with off‑balance sheet risk of accounting loss. |
Warrants | Warrants The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity . ASC 480 requires that a financial instrument, other than an outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using the Black-Scholes option-pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations. In connection with the completion of the Company's initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Warrants with non-standard anti-dilution provisions (referred to as down round protection) are classified as liabilities and re-measured each reporting period. On January 1, 2019, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11 Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception, which indicates that a down round feature no longer precludes equity classification when assessing whether an investment is indexed to an entity’s own stock. The Company used a modified retrospective approach to adoption, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. Warrants to purchase 62,505 shares of common stock at $6.00 per share expired on December 14, 2019, and none of these warrants are outstanding as of December 31, 2019. The warrants issued in connection with the Company's debt financing completed in February 2015 (see Note 8) are classified as a component of stockholders' equity. The value of such warrants was determined using the Black-Scholes option-pricing model. As of December 31, 2019, there were outstanding 180,274 warrants to purchase common stock at $5.89 per share related to this debt financing. These warrants expire on February 24, 2020. |
Income Taxes | Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2019 that qualifies for either recognition or disclosure in the financial statements under this guidance. |
Stock-Based Compensation | Stock‑Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting segment, which is the business of developing its transdermal patch for use in contraception. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the years ended December 31, 2019, 2018 and 2017, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2019 2018 2017 Common stock warrants 180,274 242,779 Unvested restricted stock units — 264,361 Common stock options 7,192,357 3,805,305 Total 7,372,631 4,312,445 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures. In February 2016, the FASB issued ASU No. 2016-02, Leases . The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company adopted ASU No. 2016-02 on January 1, 2019. The Company recorded a lease asset and lease liability of approximately $0.3 million on its balance sheet as of January 1, 2019, with no impact on its statement of operations. In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. This ASU eliminates the requirement to consider “down round” features when determining whether certain equity-linked financial instruments or embedded features are indexed to an entity’s own stock. On January 1, 2019, the Company adopted the provisions of ASU No. 2017-11 using a modified retrospective approach, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. As a result of the adoption of ASU 2017-11, effective January 1, 2019, the Company no longer measures these warrants at fair value. In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting to provide clarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to change the terms or conditions of a share-based payment award. The amendments in this ASU provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This Update is the final version of Proposed ASU 2016-360—Compensation—Stock Compensation (Topic 718)—Scope of Modification Accounting, which has been deleted. The amendments in this ASU are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. The adoption of this ASU did not have a material impact on the Company's financial statements. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses rather than incurred losses to estimate credit losses on certain types of financial instruments, including trade receivables. ASU 2016-13 was adopted by the Company on January 1, 2020 and has no current impact on the Company as we do not have any financial instruments covered by the topic. Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the years ended December 31, 2019, 2018 and 2017, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2019 2018 2017 Common stock warrants 180,274 242,779 Unvested restricted stock units — 264,361 Common stock options 7,192,357 3,805,305 Total 7,372,631 4,312,445 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Measurements | |
Schedule of financial instruments measured at fair value by level within the fair value hierarchy | Level 1 Level 2 Level 3 2019 Assets: Cash equivalents $ 34,444 $ — $ — Total assets at fair value $ 34,444 $ — $ — Level 1 Level 2 Level 3 2018 Assets: Cash equivalents $ 7,776 $ — $ — Total assets at fair value $ 7,776 $ — $ — |
Schedule of rollforward of the fair value of Level 3 warrants | Beginning balance at December 31, 2016 $ 172 Change in fair value (143) Ending balance at December 31, 2017 29 Change in fair value (29) Ending balance at December 31, 2018 — Change in fair value — Ending balance at December 31, 2019 $ — |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Prepaid Expenses | |
Schedule of prepaid expenses | December 31, 2019 2018 Prepaid insurance $ 656 $ 484 Other 184 Total prepaid expenses $ 840 $ |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment | |
Schedule of components of property and equipment | December 31, 2019 2018 Estimated Life Office equipment $ 49 $ 3 - 10 years Computer equipment 179 3 years Manufacturing equipment 14,203 5 years 14,431 Less: accumulated depreciation (387) Property and equipment $ 14,044 $ |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Liabilities | |
Schedule of accrued liabilities | December 31, 2019 2018 Employee bonuses $ 1,437 $ Accrued retention bonus — Accrued professional fees and other 367 Total accrued liabilities $ 1,804 $ |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of December 31, 2019 were as follows: 2020 $ 191 Total $ 191 Less: Interest (19) Present value of lease liability $ 172 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity Incentive Plans | |
Schedule of stock-based compensation expense | Year Ended December 31, 2019 2018 2017 Research and development $ 522 $ $ 1,184 General and administrative 1,240 2,467 Total $ 1,762 $ $ 3,651 |
Schedule of assumptions used to compute employee stock-based compensation | 2019 2018 2017 Risk-free interest rate 1.74 % - 2.61 % 2.57 % 2.27 % Expective volatility 65.0 % 70.0 % 73.9 % Expected dividend yield 0 % 0 % 0 % Expected life (in years) 6.25 6.25 6.25 |
Summary of options outstanding, vested and exercisable | Weighted Weighted Average Average Remaining Exercise Contractual Aggregate Options Price Life (Years) Intrinsic Value Options outstanding at December 31, 2017 3,805,305 5.74 7.4 Options granted 2,230,000 1.96 Options exercised — — Options cancelled/forfeited (347,404) 4.19 Options outstanding at December 31, 2018 5,687,901 4.34 7.4 Options granted 2,805,600 1.18 Options exercised (92,271) 1.78 Options cancelled/forfeited (1,208,873) 2.70 Options outstanding at December 31, 2019 7,192,357 3.42 7.2 $ 5,256 Options exercisable at December 31, 2019 4,396,577 4.60 6.1 $ 2,228 Vested and expected to vest at December 31, 2019 7,192,357 $ 5,256 |
Schedule of restricted stock activity | Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2017 264,361 3.16 Granted 108,254 3.46 Vested (225,061) 3.39 $ 370 Restricted stock units outstanding at December 31, 2018 147,554 3.03 Vested (147,554) 3.03 $ 129 Restricted stock units outstanding at December 31, 2019 — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Schedule of tax effects of temporary differences that give rise to significant portions of deferred tax assets | December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 55,216 $ Research credit carryforward 7,609 Stock options and other 3,225 Total gross deferred tax assets 66,050 Valuation allowance for deferred tax assets (66,050) Net deferred tax assets $ — $ — |
Schedule of reconciliation of U.S. statutory income tax rate to effective tax rate | December 31, 2019 2018 2017 Federal income tax at statutory rate % % % State income tax benefit, net of federal benefit % % % Research and development tax credits % % % Effect of tax rate changes % % -94.0 % Other -4.0 % -4.0 % -1.0 % Decrease (increase) to valuation allowance -28.0 % -24.0 % % Effective income tax rate % % % |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring Costs | |
Summary of accrued restructuring costs, included as a component of accrued liabilities | December 31, 2018 Charges Payments December 31, 2019 Accrued retention bonus 638 — (638) — Total $ 638 $ — $ (638) $ — |
Quarterly Data (Unaudited) (Tab
Quarterly Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Data (Unaudited) | |
Summary of quarterly results of operations | These quarterly results are unaudited, but in the opinion of management, have been prepared on the same basis as our audited financial information and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information set forth herein (in thousands, except per share amounts). March 31, June 30, September 30, December 31, 2019 2019 2019 2019 Total revenue $ — $ — $ — $ — Operating expenses $ 4,707 $ 3,547 $ 4,499 $ 6,105 Net loss $ (4,669) $ (3,484) $ (4,432) $ (6,021) Basic and diluted net loss per common share $ (0.13) $ (0.08) $ (0.08) $ (0.10) March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Total revenue $ — $ — $ — $ — Operating expenses $ $ $ $ Net loss $ $ $ $ Basic and diluted net loss per common share $ (0.20) $ (0.16) $ (0.11) $ (0.11) |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Feb. 29, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Nature of Operations | |||
Product revenue | $ 0 | ||
Accumulated deficit | (260,370) | $ (241,551) | |
Cash and cash equivalents | 34,479 | $ 7,851 | |
Perceptive | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche One | |||
Nature of Operations | |||
Amount borrowed | 5,000 | ||
Perceptive | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Two | |||
Nature of Operations | |||
Amount borrowed | $ 15,000 | ||
Subsequent Event | Perceptive | Senior secured delayed draw term loan facility | Perceptive Credit Agreement | |||
Nature of Operations | |||
Maximum borrowing capacity | $ 35,000 | ||
Subsequent Event | Perceptive | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche One | |||
Nature of Operations | |||
Amount borrowed | 5,000 | ||
Subsequent Event | Perceptive | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Two | |||
Nature of Operations | |||
Amount borrowed | $ 15,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Interest expense | |||
Deferred Financing Costs | |||
Amortization of deferred financing costs | $ 0 | $ 133 | $ 239 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Concentration of risk, financial assets | |
Financial instruments with off-balance sheet risk of accounting loss, assets | $ 0 |
Concentration risk, financial liabilities | |
Financial instruments with off-balance sheet risk of accounting loss, liabilities | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2019 | Dec. 31, 2019 | Dec. 14, 2019 | Feb. 28, 2015 |
Additional Paid-in Capital | ||||
Warrants | ||||
Cumulative effect adjustment | $ 213 | |||
Accumulated Deficit | ||||
Warrants | ||||
Cumulative effect adjustment | $ (213) | |||
Warrants | Common stock warrants | Hercules Capital, Inc. | ||||
Warrants | ||||
Number of warrants outstanding (in shares) | 180,274 | 180,274 | ||
Exercise price of warrants (in dollars per share) | $ 5.89 | $ 5.89 | ||
ASU 2017-11 | Common stock warrants | Oxford Finance LLC | ||||
Warrants | ||||
Common stock that can be purchased with warrants (in shares) | 62,505 | |||
Number of warrants outstanding (in shares) | 0 | |||
Exercise price of warrants (in dollars per share) | $ 6 | |||
ASU 2017-11 | Adjustment | Additional Paid-in Capital | ||||
Warrants | ||||
Cumulative effect adjustment | $ 213 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Income Taxes (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Uncertainty in tax positions | |
Uncertain tax positions | $ 0 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Segment Information (Details) | 12 Months Ended |
Dec. 31, 2019segment | |
Segment Information | |
Number of operating segments | 1 |
Number of reporting segments | 1 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 7,372,631 | 6,078,234 | 4,312,445 |
Common stock warrants | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 180,274 | 242,779 | 242,779 |
Restricted Stock Units | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 147,554 | 264,361 | |
Common stock options | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 7,192,357 | 5,687,901 | 3,805,305 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
Recent Accounting Pronouncements | ||
Lease liability | $ 172 | |
ASU 2016-02 | Adjustment | ||
Recent Accounting Pronouncements | ||
Right of use and other assets | $ 300 | |
Lease liability | $ 300 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - Level 1 - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Assets: | ||
Cash and cash equivalents | $ 34,444 | $ 7,776 |
Total assets at fair value | $ 34,444 | $ 7,776 |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers Between Levels (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair value measurements | |||
Asset transfers out of Level 1 into Level 2 | $ 0 | $ 0 | |
Asset transfers out of Level 2 into Level 1 | 0 | 0 | |
Asset transfers into (out of) Level 3 | 0 | 0 | |
Liability transfers out of Level 1 into Level 2 | 0 | 0 | |
Liability transfers out of Level 2 into Level 1 | 0 | 0 | |
Liability transfers into (out of) Level 3 | 0 | 0 | |
Common stock warrants | Liabilities | |||
Rollforward of the fair value of Level 3 warrants: | |||
Beginning balance | 29 | $ 172 | |
Change in fair value | 0 | $ (29) | (143) |
Ending balance | $ 0 | $ 29 |
Prepaid Expenses (Details)
Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid Expenses | ||
Prepaid insurance | $ 656 | $ 484 |
Other | 184 | 123 |
Total prepaid expenses | $ 840 | $ 607 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property and Equipment | ||
Property and equipment, gross | $ 14,431 | $ 14,285 |
Less: accumulated depreciation | (387) | (369) |
Property and equipment, net | 14,044 | 13,916 |
Office equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 49 | $ 49 |
Office equipment | Minimum | ||
Property and Equipment | ||
Estimated Life (in years) | 3 years | 3 years |
Office equipment | Maximum | ||
Property and Equipment | ||
Estimated Life (in years) | 10 years | 10 years |
Computer equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 179 | $ 175 |
Estimated Life (in years) | 3 years | 3 years |
Manufacturing equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 14,203 | $ 14,061 |
Estimated Life (in years) | 5 years | 5 years |
Manufacturing equipment in process of being constructed and qualified | ||
Property and Equipment | ||
Property and equipment, gross | $ 14,000 | $ 13,900 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued Liabilities | ||
Employee bonuses | $ 1,437 | $ 621 |
Accrued retention bonus | 638 | |
Accrued professional fees and other | 367 | 84 |
Total accrued liabilities | $ 1,804 | $ 1,343 |
Leases - Summary (Details)
Leases - Summary (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($)lease | Jan. 01, 2019USD ($) | |
Leases | ||
Lease liability | $ 172 | |
Number of finance leases | lease | 0 | |
Number of operating leases | lease | 1 | |
Operating lease expense | $ 193 | |
Operating lease expense information: | ||
Cash paid for amounts included in measurement of lease liabilities | $ 152 | |
Weighted-average remaining lease term (years) | 11 months 1 day | |
Weighted-average discount rate | 21.20% | |
ASU 2016-02 | Adjustment | ||
Leases | ||
Lease assets | $ 300 | |
Lease liability | $ 300 |
Leases - Maturity of lease liab
Leases - Maturity of lease liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Operating Leases | |
2020 | $ 191 |
Total | 191 |
Less: Interest | (19) |
Present value of lease liability | $ 172 |
Loan and Security Agreement (De
Loan and Security Agreement (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Feb. 28, 2015USD ($)Yitem$ / sharesshares | Dec. 31, 2019USD ($)installment$ / sharesshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 01, 2018USD ($) | Aug. 31, 2016USD ($) | |
Warrants | Option pricing model | ||||||
Significant assumptions used in valuation of the Company's warrants | ||||||
Life of treasury bonds | 4 years | |||||
Warrants | Common stock warrants | Option pricing model | Volatility | ||||||
Significant assumptions used in valuation of the Company's warrants | ||||||
Warrants, Measurement Input | item | 0.750 | |||||
Warrants | Common stock warrants | Option pricing model | Risk free interest rate | ||||||
Significant assumptions used in valuation of the Company's warrants | ||||||
Warrants, Measurement Input | item | 0.0122 | |||||
Warrants | Common stock warrants | Option pricing model | Strike price | ||||||
Significant assumptions used in valuation of the Company's warrants | ||||||
Warrants, Measurement Input | item | 5.89 | |||||
Warrants | Common stock warrants | Option pricing model | Share price | ||||||
Significant assumptions used in valuation of the Company's warrants | ||||||
Warrants, Measurement Input | item | 9.82 | |||||
Warrants | Common stock warrants | Option pricing model | Expected life | ||||||
Significant assumptions used in valuation of the Company's warrants | ||||||
Warrants, Measurement Input | Y | 4 | |||||
Secured debt | ||||||
Interest expense | ||||||
Interest expense, including accretion of value of related warrants and amortization of deferred financing costs | $ 0 | $ 1,100 | $ 1,900 | |||
Secured debt | Oxford Loan | ||||||
Loan and Security Agreement | ||||||
Repayment of existing debt | $ 15,500 | |||||
Hercules Capital, Inc. | Hercules Loan ("Term Loan") | Right to participate in future equity financings | Maximum | ||||||
Loan and Security Agreement | ||||||
Equity financings amount | $ 2,000 | |||||
Hercules Capital, Inc. | Warrants | Common stock warrants | ||||||
Loan and Security Agreement | ||||||
Common stock that can be purchased with warrants (in shares) | shares | 180,274 | 180,274 | ||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 5.89 | $ 5.89 | ||||
Hercules Capital, Inc. | Additional Paid-in Capital | ||||||
Loan and Security Agreement | ||||||
Fair value of common stock warrants issued with debt financing | $ 1,200 | |||||
Hercules Capital, Inc. | Secured debt | Hercules Loan ("Term Loan") | ||||||
Loan and Security Agreement | ||||||
Maximum borrowing capacity | 25,000 | |||||
Facility Fee | $ 165 | |||||
Outstanding borrowings, current portion | $ 0 | $ 0 | ||||
Fixed interest rate (as a percent) | 9.00% | |||||
Number of consecutive monthly principal installments | installment | 23 | |||||
Final payment amount due | $ 611 | |||||
Discount on debt | 1,200 | |||||
Hercules Capital, Inc. | Secured debt | Hercules Loan Tranche One | ||||||
Loan and Security Agreement | ||||||
Amount borrowed | $ 16,500 | |||||
Hercules Capital, Inc. | Secured debt | Hercules Loan Tranche Two | ||||||
Loan and Security Agreement | ||||||
Additional amount available | $ 8,500 | |||||
Hercules Capital, Inc. | Secured debt | Prime | Hercules Loan ("Term Loan") | ||||||
Loan and Security Agreement | ||||||
Variable rate basis | Prime minus 4.25% | |||||
Variable interest rate margin (as a percent) | 9.00% | |||||
Variable rate adjustment (as a percent) | (4.25%) |
Stockholders' Equity - Amended
Stockholders' Equity - Amended and Restated Certificate of Incorporation (Details) | 12 Months Ended | |
Dec. 31, 2019classshares | Dec. 31, 2018shares | |
Stockholders' Equity | ||
Common stock, authorized (in shares) | shares | 150,000,000 | 150,000,000 |
Preferred stock, authorized (in shares) | shares | 10,000,000 | |
Board of Directors, number of classes | class | 3 | |
Term of Board member | 3 years | |
Number of classes elected at each annual meeting | class | 1 | |
Minimum | ||
Stockholders' Equity | ||
Affirmative vote of all then-outstanding shares of capital stock for removal of directors (as a percent) | 75.00% |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||||||||
Aug. 31, 2019USD ($)$ / sharesshares | Aug. 31, 2017USD ($)$ / sharesshares | Feb. 29, 2016$ / sharesshares | Jan. 31, 2016USD ($)shareholder$ / sharesshares | Feb. 29, 2016USD ($)$ / sharesshares | Dec. 31, 2019USD ($)shares | Dec. 31, 2017USD ($)shares | Nov. 08, 2019USD ($) | Jan. 23, 2019USD ($) | Nov. 02, 2018USD ($) | Jun. 19, 2015USD ($) | |
2018 Shelf Registration Statement | |||||||||||
Sale of stock | |||||||||||
Aggregate amount of securities issuable | $ 100,000 | ||||||||||
2015 Shelf Registration Statement | |||||||||||
Sale of stock | |||||||||||
Aggregate amount of securities issuable | $ 150,000 | ||||||||||
2016 Public Offering | Stockholders affiliated with members of board of directors | |||||||||||
Sale of stock | |||||||||||
Sale of Stock, Number of Stockholders Affiliated with Members of Board of Directors Who Purchased Shares in Transaction | shareholder | 1 | ||||||||||
2016 Public Offering | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 5,511,812 | 6,338,583 | |||||||||
Share price (in dollars per share) | $ / shares | $ 6.35 | ||||||||||
Proceeds from sales or issuance of common stock, net of offering costs | $ 37,500 | ||||||||||
2016 Public Offering | Common Stock | Stockholders affiliated with members of board of directors | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 393,700 | ||||||||||
Proceeds from sales or issuance of common stock, net of offering costs | $ 2,500 | ||||||||||
2017 Public Offering | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 5,333,334 | ||||||||||
Share price (in dollars per share) | $ / shares | $ 3.75 | ||||||||||
Proceeds from sales or issuance of common stock, net of offering costs | $ 18,500 | ||||||||||
Private Placement | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 8,426,750 | ||||||||||
Underwriter purchase option | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 826,771 | ||||||||||
Share price (in dollars per share) | $ / shares | $ 6.35 | $ 6.35 | |||||||||
At-the-market sales | |||||||||||
Sale of stock | |||||||||||
Proceeds from sales or issuance of common stock, net of offering costs | $ 42,251 | $ 18,535 | |||||||||
At-the-market sales | Maximum | |||||||||||
Sale of stock | |||||||||||
Authorized value for shares issuance | $ 20,000 | $ 10,000 | |||||||||
At-the-market sales | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 12,242,436 | ||||||||||
At Market Sales on January 23 | |||||||||||
Sale of stock | |||||||||||
Proceeds from sales or issuance of common stock, net of offering costs | $ 2,500 | ||||||||||
At Market Sales on January 23 | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 1,801,528 | ||||||||||
At Market Sales on November 8 | |||||||||||
Sale of stock | |||||||||||
Proceeds from sales or issuance of common stock, net of offering costs | $ 19,300 | ||||||||||
At Market Sales on November 8 | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 10,440,908 | ||||||||||
Public offering | Common Stock | |||||||||||
Sale of stock | |||||||||||
Issuance of common stock (in shares) | shares | 14,526,315 | 14,526,315 | 5,333,334 | ||||||||
Share price (in dollars per share) | $ / shares | $ 0.95 | ||||||||||
Proceeds from sales or issuance of common stock, net of offering costs | $ 12,700 |
Equity Incentive Plans - Stock
Equity Incentive Plans - Stock Options Summary (Details) - Common stock options | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Minimum | |
Equity Incentive Plans | |
Exercise prices of options granted through the end of the year (in dollars per share) | $ 0.58 |
Maximum | |
Equity Incentive Plans | |
Exercise prices of options granted through the end of the year (in dollars per share) | $ 10.75 |
1997 Plan and 2008 Plan | |
Equity Incentive Plans | |
Expiration period | 10 years |
Vesting period | 4 years |
2014 Equity Incentive Plan | |
Equity Incentive Plans | |
Shares available for grant | shares | 2,170,175 |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 1,762 | $ 3,630 | $ 3,651 |
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Risk-free interest rate (as a percent) | 2.61% | 2.57% | 2.27% |
Expective volatility (as a percent) | 65.00% | 70.00% | 73.90% |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Expected life (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Minimum | |||
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Risk-free interest rate (as a percent) | 1.74% | ||
Common stock options | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 1,762 | $ 3,630 | $ 3,651 |
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 1,900 | ||
Weighted-average amortization period over which cost is expected to be recognized | 1 year 4 months 24 days | ||
Weighted average grant date fair value of options granted (in dollars per share) | $ 0.59 | ||
Common stock options | Research and development | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 522 | 1,274 | 1,184 |
Common stock options | General and administrative | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 1,240 | $ 2,356 | $ 2,467 |
Equity Incentive Plans - Stoc_2
Equity Incentive Plans - Stock Option Activity (Details) - Common stock options - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Options | |||
Options outstanding at beginning of year (in shares) | 5,687,901 | 3,805,305 | |
Options granted (in shares) | 2,805,600 | 2,230,000 | |
Options exercised (in shares) | (92,271) | 0 | |
Options cancelled/forfeited (in shares) | (1,208,873) | (347,404) | |
Options outstanding at end of year (in shares) | 7,192,357 | 5,687,901 | 3,805,305 |
Options exercisable at end of year (in shares) | 4,396,577 | ||
Vested and expected to vest at end of year (in shares) | 7,192,357 | ||
Weighted Average Exercise Price | |||
Options outstanding at beginning of year (in dollars per share) | $ 4.34 | $ 5.74 | |
Options granted (in dollars per share) | 1.18 | 1.96 | |
Options exercised (in dollars per share) | 1.78 | 0 | |
Options cancelled/forfeited (in dollars per share) | 2.70 | 4.19 | |
Options outstanding at end of year (in dollars per share) | 3.42 | $ 4.34 | $ 5.74 |
Options exercisable at end of year (in dollars per share) | 4.60 | ||
Vested and expected to vest at end of year (in dollars per share) | $ 0 | ||
Weighted Average Remaining Contractual Life (Years) | |||
Options outstanding | 7 years 2 months 12 days | 7 years 4 months 24 days | 7 years 4 months 24 days |
Options exercisable | 6 years 1 month 6 days | ||
Aggregate Intrinsic Value | |||
Options outstanding at the end of the year (in dollars) | $ 5,256 | ||
Options exercisable at the end of the year (in dollars) | 2,228 | ||
Vested and expected to vest at end of year | $ 5,256 | ||
Estimated stock price (in dollars per share) | $ 2.50 |
Equity Incentive Plans - Restri
Equity Incentive Plans - Restricted Stock (Details) - Restricted Stock Units - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Feb. 28, 2018 | Feb. 28, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares | ||||||
Restricted stock outstanding at beginning of year (in shares) | 147,554 | 264,361 | ||||
Granted (in shares) | 108,254 | |||||
Vested (in shares) | (147,554) | (225,061) | ||||
Restricted stock outstanding at end of year (in shares) | 0 | 147,554 | 264,361 | |||
Weighted Average Grant Date Fair Value | ||||||
Restricted stock outstanding at beginning of year (in dollars per share) | $ 3.03 | $ 3.16 | ||||
Granted (in dollars per share) | 3.46 | |||||
Vested (in dollars per share) | 3.03 | 3.39 | ||||
Restricted stock outstanding at end of year (in dollars per share) | $ 0 | $ 3.03 | $ 3.16 | |||
Aggregate Intrinsic Value | ||||||
Intrinsic value of vested shares | $ 129 | $ 370 | ||||
Employee | ||||||
Shares | ||||||
Granted (in shares) | 50,000 | |||||
Vested (in shares) | (16,667) | (16,667) | (16,666) | |||
Executive officers | ||||||
Shares | ||||||
Granted (in shares) | 108,254 | 247,694 | ||||
Vesting period | 1 year | 2 years | ||||
Directors | ||||||
Shares | ||||||
Vesting period | 1 year |
Equity Incentive Plans - Perfor
Equity Incentive Plans - Performance Based Restricted Stock Awards (Details) - 2014 Equity Incentive Plan - Performance Units - Executive officers - shares | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2019 | |
Equity Incentive Plans | ||||
Shares granted | 365,000 | 50,000 | 260,000 | |
Shares outstanding | 315,000 | 315,000 |
Income Taxes - Summary (Details
Income Taxes - Summary (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes | |||
Corporate tax rate (as a percent) | 21.00% | 21.00% | 34.00% |
Federal | Net Operating Losses | |||
Income Taxes | |||
Net operating loss carryforwards | $ 231.5 | $ 198.9 | |
Indefinite net operating loss carryforward | 32.5 | $ 32.5 | |
Federal | Research and Development | |||
Income Taxes | |||
Tax credit carryforwards | 6.3 | ||
State | Net Operating Losses | |||
Income Taxes | |||
Net operating loss carryforwards | 92.4 | ||
State | Research and Development | |||
Income Taxes | |||
Tax credit carryforwards | $ 1.6 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 55,216 | $ 51,240 |
Research credit carryforward | 7,609 | 6,904 |
Stock options and other | 3,225 | 2,655 |
Total gross deferred tax assets | 66,050 | 60,799 |
Valuation allowance for deferred tax assets | (66,050) | (60,799) |
Net deferred tax assets | 0 | 0 |
Valuation allowance | ||
Increase (decrease) in the valuation allowance | $ 5,300 | $ 4,800 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. Statutory Income Tax Rate to Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of the U.S. statutory income tax rate to the Company's effective tax rate | |||
Federal income tax at statutory rate (as a percent) | 21.00% | 21.00% | 34.00% |
State income tax benefit, net of federal benefit (as a percent) | 7.00% | 6.00% | 6.00% |
Research and development tax credits (as a percent) | 4.00% | 3.00% | 3.00% |
Effect of tax rate changes (as a percent) | 0.00% | 0.00% | (94.00%) |
Other (as a percent) | (4.00%) | (4.00%) | (1.00%) |
Decrease (increase) to valuation allowance (as a percent) | (28.00%) | (24.00%) | 52.00% |
Effective income tax rate (as a percent) | 0.00% | 2.00% | 0.00% |
Income Taxes - Sale of New Jers
Income Taxes - Sale of New Jersey Net Operating Losses (Details) - USD ($) $ in Millions | 1 Months Ended | |
Jan. 31, 2018 | Dec. 31, 2019 | |
Technology Business Tax Certificate Program | New Jersey | ||
Sale of New Jersey Net Operating Losses | ||
NOLs | $ 0.5 | |
Maximum lifetime benefit under the Program | $ 15 | |
Technology Business Tax Certificate Program | New Jersey | Minimum | ||
Sale of New Jersey Net Operating Losses | ||
Allowable sale of unused tax benefits as a percentage of total value | 80.00% | |
Net Operating Losses | State | ||
Sale of New Jersey Net Operating Losses | ||
NOLs | $ 92.4 | |
Research and Development | State | ||
Sale of New Jersey Net Operating Losses | ||
Tax credits | $ 1.6 |
Restructuring Costs (Details)
Restructuring Costs (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Dec. 31, 2019USD ($)installment$ / shares | Dec. 31, 2018USD ($) | |
Restructuring Costs | |||
Reduction in workforce (as a percent) | 30.00% | ||
Restructuring Costs | |||
Beginning balance | $ 638 | ||
Charges | 0 | $ 1,019 | |
Payments | (638) | ||
Ending balance | 0 | 638 | |
Accrued retention bonus | |||
Restructuring Costs | |||
Beginning balance | 638 | ||
Charges | 0 | ||
Payments | (638) | ||
Ending balance | 0 | $ 638 | |
Retention Plan | |||
Restructuring Costs | |||
Cash portion of the retention plan | $ 600 | ||
Stock option exercise price (in dollars per share) | $ / shares | $ 0.58 | ||
Number of installments for option to vest | installment | 4 | ||
Retention Plan | Vesting on June 20, 2018 | |||
Restructuring Costs | |||
Percentage of options to vest | 25.00% | ||
Retention Plan | Vesting on December 31, 2018 | |||
Restructuring Costs | |||
Percentage of options to vest | 25.00% | ||
Retention Plan | Vesting on June 30, 2019 | |||
Restructuring Costs | |||
Percentage of options to vest | 25.00% | ||
Retention Plan | Vesting on December 31, 2019 | |||
Restructuring Costs | |||
Percentage of options to vest | 25.00% |
2019 Retention Plan (Details)
2019 Retention Plan (Details) $ / shares in Units, $ in Millions | Jul. 03, 2019 | Dec. 31, 2019installment$ / shares | Jul. 31, 2019USD ($) |
Options granted In January 2019 | Vesting on January 29, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 50.00% | ||
Options granted In January 2019 | Vesting on June 30, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 25.00% | ||
Options granted In January 2019 | Vesting on December 31, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 25.00% | ||
Options granted in July 2019 | |||
2019 Retention Plan | |||
Stock option exercise price (in dollars per share) | $ / shares | $ 1.48 | ||
Number of installments for option to vest | installment | 2 | ||
Options granted in July 2019 | Vesting on July 3, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 50.00% | ||
Options granted in July 2019 | Vesting on December 31, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 50.00% | ||
2019 Retention Plan | |||
2019 Retention Plan | |||
Cash portion of the retention plan | $ | $ 0.3 |
Subsequent Event (Details)
Subsequent Event (Details) - Perceptive $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended |
Feb. 29, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | |
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche One | ||
Subsequent Event [Line Items] | ||
Amount borrowed | $ 5 | |
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Two | ||
Subsequent Event [Line Items] | ||
Amount borrowed | $ 15 | |
Subsequent Event | Perceptive Credit Agreement | Perceptive Warrants | ||
Subsequent Event [Line Items] | ||
Common stock that can be purchased with warrants (in shares) | shares | 1,400,000 | |
Subsequent Event | Perceptive Credit Agreement | First Seven Lakhs Shares | ||
Subsequent Event [Line Items] | ||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.74 | |
Common stock that can be purchased with warrants (in shares) | shares | 700,000 | |
Volume weighted average exercise price period | 5 days | |
Subsequent Event | Perceptive Credit Agreement | Remaining Seven Lakhs Shares | ||
Subsequent Event [Line Items] | ||
Exercise price of warrants (in dollars per share) | $ / shares | $ 4.67 | |
Common stock that can be purchased with warrants (in shares) | shares | 700,000 | |
Number of times on five day volume weighted average exercise price | 1.25 | |
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement | ||
Subsequent Event [Line Items] | ||
Maximum borrowing capacity | $ 35 | |
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche One | ||
Subsequent Event [Line Items] | ||
Amount borrowed | 5 | |
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Two | ||
Subsequent Event [Line Items] | ||
Amount borrowed | 15 | |
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Three | ||
Subsequent Event [Line Items] | ||
Additional amount available | $ 15 |
Quarterly Data (Unaudited) - Qu
Quarterly Data (Unaudited) - Quarterly Results of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Data (Unaudited) | |||||||||||
Total revenue | $ 0 | ||||||||||
Operating expenses | $ 6,105 | $ 4,499 | $ 3,547 | $ 4,707 | $ 3,727 | $ 3,615 | $ 5,147 | $ 7,046 | 18,858 | $ 19,535 | $ 26,811 |
Net loss | $ (6,021) | $ (4,432) | $ (3,484) | $ (4,669) | $ (3,810) | $ (3,792) | $ (5,344) | $ (6,833) | $ (18,606) | $ (19,779) | $ (28,304) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.10) | $ (0.08) | $ (0.08) | $ (0.13) | $ (0.11) | $ (0.11) | $ (0.16) | $ (0.20) | $ (0.38) | $ (0.58) | $ (0.91) |
Quarterly Data (Unaudited) - Ta
Quarterly Data (Unaudited) - Tax Benefit from Sale of New Jersey State Net Operating Losses (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2018USD ($) | |
New Jersey | Technology Business Tax Certificate Program | |
Sale of New Jersey Net Operating Losses | |
Tax benefit | $ 0.5 |