Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 10, 2020 | Jun. 28, 2019 | |
Document and Entity Information | |||
Entity Registrant Name | TREVENA INC | ||
Entity Central Index Key | 0001429560 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Public Float | $ 93.9 | ||
Entity Common Stock, Shares Outstanding | 97,727,185 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 32,305 | $ 32,892 |
Marketable securities | 3,500 | 28,590 |
Prepaid expenses and other current assets | 1,683 | 607 |
Total current assets | 37,488 | 62,089 |
Restricted cash | 1,309 | 1,303 |
Property and equipment, net | 2,705 | 3,387 |
Right-of-use lease asset | 5,472 | |
Other assets | 20 | |
Total assets | 46,994 | 66,779 |
Current liabilities: | ||
Accounts payable, net | 1,047 | 1,416 |
Accrued expenses and other current liabilities | 2,403 | 3,295 |
Current portion of loans payable, net | 5,037 | 12,562 |
Lease liability | 620 | 10 |
Deferred rent | 207 | |
Total current liabilities | 9,107 | 17,490 |
Loans payable, net | 4,811 | |
Leases, net of current portion | 7,804 | 20 |
Deferred rent, net of current portion | 2,931 | |
Warrant liability | 5 | 1 |
Total liabilities | 16,916 | 25,253 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Common stock - $0.001 par value; 200,000,000 shares authorized at December 31, 2019 and December 31, 2018; 94,213,760 and 82,323,413 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 94 | 82 |
Preferred stock - $0.001 par value; 5,000,000 shares authorized, none issued or outstanding at December 31, 2019 and December 31, 2018 | ||
Additional paid-in capital | 443,129 | 429,727 |
Accumulated deficit | (413,145) | (388,274) |
Accumulated other comprehensive loss | (9) | |
Total stockholders' equity | 30,078 | 41,526 |
Total liabilities and stockholders' equity | $ 46,994 | $ 66,779 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock issued (in shares) | 94,213,760 | 82,323,413 |
Common stock outstanding (in shares) | 94,213,760 | 82,323,413 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock issued (in shares) | 0 | 0 |
Preferred stock outstanding (in shares) | 0 | 0 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue: | |||
Total revenue | $ 31 | $ 5,732 | $ 0 |
Revenue, Product and Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | |||
General and administrative | $ 13,212 | $ 18,979 | $ 19,639 |
Research and development | 13,291 | 15,824 | 48,974 |
Restructuring charges | 1,427 | 1,774 | |
Impairment of property and equipment | 108 | ||
Total operating expenses | 26,611 | 36,230 | 70,387 |
Loss from operations | (26,580) | (30,498) | (70,387) |
Other income (expense): | |||
Change in fair value of warrant liability | (4) | 9 | 65 |
Net (loss) gain on asset disposals | (12) | 107 | (56) |
Other income, net | 2,254 | 1,567 | 614 |
Interest income | 418 | 1,001 | 679 |
Interest expense | (931) | (2,231) | (2,780) |
(Loss) gain on foreign currency exchange | (16) | 6 | |
Total other income (expense) | 1,709 | 459 | (1,478) |
Loss before income tax expense | (24,871) | (30,039) | (71,865) |
Foreign income tax expense | (745) | ||
Net loss attributable to common stockholders | (24,871) | (30,784) | (71,865) |
Other comprehensive gain (loss), net: | |||
Unrealized gain (loss) on marketable securities | 9 | 33 | (44) |
Other comprehensive gain (loss), net | 9 | 33 | (44) |
Comprehensive loss | $ (24,862) | $ (30,751) | $ (71,909) |
Per share information: | |||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.27) | $ (0.42) | $ (1.21) |
Weighted average common shares outstanding, basic and diluted (in shares) | 91,677,963 | 73,558,548 | 59,436,649 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Beginning Balance at Dec. 31, 2016 | $ 56 | $ 364,148 | $ (285,625) | $ 2 | $ 78,581 |
Balance (in shares) at Dec. 31, 2016 | 55,768,414 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 6,387 | 6,387 | |||
Exercise of stock options | 361 | 361 | |||
Exercise of stock options (in shares) | 293,809 | ||||
Issuance of warrants | 501 | 501 | |||
Issuance of common stock, net of issuance costs | $ 6 | 20,706 | 20,712 | ||
Issuance of common stock, net of issuance costs (in shares) | 6,248,572 | ||||
Unrealized gain (loss) on marketable securities | (44) | (44) | |||
Net loss | (71,865) | (71,865) | |||
Ending Balance at Dec. 31, 2017 | $ 62 | 392,103 | (357,490) | (42) | 34,633 |
Balance (in shares) at Dec. 31, 2017 | 62,310,795 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 4,367 | 4,367 | |||
Exercise of stock options | 83 | 83 | |||
Exercise of stock options (in shares) | 133,074 | ||||
Issuance of common stock, net of issuance costs | $ 20 | 33,174 | 33,194 | ||
Issuance of common stock, net of issuance costs (in shares) | 19,879,544 | ||||
Unrealized gain (loss) on marketable securities | 33 | 33 | |||
Net loss | (30,784) | (30,784) | |||
Ending Balance at Dec. 31, 2018 | $ 82 | 429,727 | (388,274) | (9) | $ 41,526 |
Balance (in shares) at Dec. 31, 2018 | 82,323,413 | 82,323,413 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 3,232 | $ 3,232 | |||
Exercise of stock options | 28 | 28 | |||
Exercise of stock options (in shares) | 41,968 | ||||
Issuance of warrants | 347 | 347 | |||
Issuance of common stock, net of issuance costs | $ 12 | 9,953 | 9,965 | ||
Issuance of common stock, net of issuance costs (in shares) | 11,442,408 | ||||
Shares repurchased by the Company (in shares) | (122) | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | (158) | (158) | |||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 406,093 | ||||
Unrealized gain (loss) on marketable securities | $ 9 | 9 | |||
Net loss | (24,871) | (24,871) | |||
Ending Balance at Dec. 31, 2019 | $ 94 | $ 443,129 | $ (413,145) | $ 30,078 | |
Balance (in shares) at Dec. 31, 2019 | 94,213,760 | 94,213,760 |
Statement of Stockholders' Equi
Statement of Stockholders' Equity (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Common Stock | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | 134 Months Ended | |||||
Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | |
Operating activities: | ||||||||
Net loss | $ (6,445) | $ (5,169) | $ (7,976) | $ (9,021) | $ (24,871) | $ (30,784) | $ (71,865) | |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 562 | 645 | 490 | |||||
Stock-based compensation | 3,232 | 4,367 | 6,387 | |||||
Noncash interest expense on loans | 331 | 786 | 1,050 | |||||
Impairment of property and equipment | 108 | $ 0 | ||||||
Loss on disposal of assets | 12 | 177 | 70 | |||||
Revaluation of warrant liability | 4 | (9) | (65) | |||||
(Accretion) amortization of bond (discount) premium on marketable securities | (484) | (182) | 474 | |||||
Change in right-of-use asset | 301 | |||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | (1,122) | 786 | 612 | |||||
Operating lease liabilities | (482) | |||||||
Accounts payable, accrued expenses and other liabilities | (1,258) | (1,161) | (8,408) | |||||
Net cash used in operating activities | (23,667) | (25,375) | (71,255) | |||||
Investing activities: | ||||||||
Purchases of property and equipment | (169) | (3,495) | ||||||
Maturities of marketable securities | 79,389 | 68,982 | 99,018 | |||||
Purchases of marketable securities | (53,806) | (47,813) | (62,743) | |||||
Net cash provided by investing activities | 25,583 | 21,000 | 32,780 | |||||
Financing activities: | ||||||||
Proceeds from exercise of common stock options | 28 | 83 | 361 | |||||
Proceeds from issuance of common stock, net | 10,312 | 33,195 | 20,712 | |||||
Payment of employee withholding taxes on vested restricted stock units | (158) | |||||||
Capital lease payments | (12) | |||||||
Capital lease payments | (11) | (8) | ||||||
Proceeds from loans payable, net | 9,921 | |||||||
Repayments of loans payable, net | (12,667) | (12,667) | ||||||
Net cash (used in) provided by financing activities | (2,497) | 20,600 | 30,986 | |||||
Net (decrease) increase in cash, cash equivalents and restricted cash | (581) | 16,225 | (7,489) | |||||
Cash, cash equivalents and restricted cash - beginning of period | $ 34,195 | $ 17,970 | 34,195 | 17,970 | 25,459 | |||
Cash, cash equivalents and restricted cash - end of period | $ 33,614 | $ 34,195 | 33,614 | 34,195 | 17,970 | $ 34,195 | ||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid for interest | 600 | $ 1,446 | 1,730 | |||||
Capital lease additions | 27 | |||||||
Fair value of common stock warrants issued to underwriters | $ 347 | $ 501 |
Organization and Description of
Organization and Description of the Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Description of the Business | |
Organization and Description of the Business | 1. Organization and Description of the Business Trevena, Inc., or the Company, was incorporated in Delaware as Parallax Therapeutics, Inc. on November 9, 2007. The Company began operations in December 2007, and its name was changed to Trevena, Inc. on January 3, 2008. The Company is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by central nervous system, or CNS, disorders. The Company operates in one segment and has its principal office in Chesterbrook, Pennsylvania. Since commencing operations in 2007, the Company has devoted substantially all of its financial resources and efforts to research and development, including nonclinical studies and clinical trials. The Company has never been profitable and has not yet commenced commercial operations. In November 2018, the U.S. Food and Drug Administration, or FDA, issued a complete response letter, or CRL, with respect to the Company’s new drug application, or NDA, for oliceridine. In the CRL, the FDA requested additional clinical data on the QT interval and indicated that the submitted safety database was not of adequate size for the proposed labeling. The FDA also requested certain additional nonclinical data and validation reports. In January 2019, the Company announced the receipt of the official Type A meeting minutes from the FDA regarding the CRL wherein the FDA agreed that the current oliceridine safety database would support labeling at a maximum daily dose of 27 mg. The FDA also agreed that the Company could conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms. The Company initiated the healthy volunteer QT study in June 2019 following its receipt of feedback from the FDA on key design elements for the study and analysis plan. In August 2019, the Company announced that it had completed enrollment in the healthy volunteer QT study, completed the nonclinical work to characterize the 9662 metabolite, and completed the remaining product validation reports requested by the FDA. In November 2019, the Company reported topline data from the healthy volunteer QT study. In February 2020, the Company resubmitted the oliceridine NDA. See Note 17 for additional information. Since the Company’s inception, the Company has incurred losses and negative cash flows from operations. At December 31, 2019, the Company had an accumulated deficit of $413.1 million. The Company’s net loss was $24.9 million, $30.8 million and $71.9 million for the years ended December 31, 2019, 2018 and 2017, respectively. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements—Going Concern , or ASC 205-40, which requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The Company believes its existing balance of cash and cash equivalents of $32.3 million and marketable securities of $3.5 million as of December 31, 2019 is not sufficient to fund operations within one year from the date these financial statements are issued. As a result, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s plans to mitigate this risk include raising additional capital through equity or debt financings, or through strategic transactions. However, under the requirements of ASC 205-40, management did not consider the potential future capital raises or other plans to mitigate this risk in their assessment of the Company’s ability to meet its obligations for the next twelve months as they were unable to conclude that such plans were probable to occur. Management’s plans may also include the possible deferral of certain operating expenses unless and until additional capital is received. There can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses. If the Company is unable to raise sufficient additional capital or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations and planned capital expenditures. Certain prior period amounts have been reclassified to conform to the current period presentation, the effect of which was not material to the Company’s interim 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 Policies Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and Accounting Standards Update, or ASU, of FASB. The Company’s functional currency is the U.S. dollar. Use of Estimates The preparation of 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. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of liability-classified common stock warrants, the accounting for research and development costs, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents are valued at cost, which approximates their fair market value. The Company maintains a portion of its cash and cash equivalent balances in money market mutual funds that may invest substantially all of their assets in U.S. government agency securities and U.S. Treasury securities. The Company classifies its marketable securities as “available-for-sale,” pursuant to ASC Topic 320, Investments—Debt and Equity Securities , or ASC 320, carries them at fair market value and classifies them as current assets on its balance sheets. Unrealized gains and losses on marketable securities are recorded as a separate component of accumulated other comprehensive income (loss) included in stockholders’ equity. As of December 31, 2019 and 2018, the Company had $3.5 million and $28.6 million, respectively, in available-for-sale investments, all classified as current assets. See Note 3 for additional information. The fair value of the Company’s investments is determined based on observable market quotes or valuation models using assessments of counterparty credit worthiness, credit default risk of underlying security and overall capital market liquidity. The Company reviews unrealized losses associated with available-for-sale securities to determine the classification as “temporary” or “other-than-temporary” impairment. A temporary impairment results in an unrealized loss being recorded in other comprehensive income (loss). If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is transferred from other comprehensive income (loss) to the statement of operations. The Company considers various factors in determining the classification, including the length of time and extent to which the fair value has been less than the Company’s cost basis, the financial condition and near-term prospects of the issuer or investee, and the Company’s ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. Realized gains (losses) are included in interest income (expense) in the statement of operations and comprehensive income (loss) on a specific identification basis. Restricted Cash The Company maintains $1.3 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, marketable securities, restricted cash, accounts payable and accrued expenses approximate their fair values, given their short-term nature. The carrying amount of the Company’s loans payable at December 31, 2019 and 2018 is the nominal value of the loan payable, net of debt discount and deferred charges. The nominal value approximates fair value because the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, marketable securities and restricted cash. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. Property and Equipment Property and equipment consists of computer and laboratory equipment, software, office equipment, furniture, manufacturing equipment and leasehold improvements and is recorded at cost. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred. Upon disposal, retirement or sale, the related cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Property and equipment are depreciated on a straight‑line basis over their estimated useful lives. The Company uses a life of three years for computer equipment and five years for laboratory equipment, office equipment, furniture, manufacturing equipment and software. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. The Company reviews long‑lived assets when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses were recorded since inception through December 31, 2018. $0.1 million of impairment losses were recorded during the year ended December 31, 2019. Leases At the commencement of a lease, the Company recognizes a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term, including variable fees that are known or subject to a minimum floor. The lease liability includes lease component fees, while non-lease component fees are expensed as incurred for all asset classes. When a contract excludes an implicit rate, the Company utilizes an incremental borrowing rate based on information available at the lease commencement date including lease term and geographic region. The initial valuation of the right-of-use, or ROU, asset includes the initial measurement of the lease liability, lease payments made in advance of the lease commencement date, and initial direct costs incurred by the Company and excludes lease incentives. Leases with an initial term of 12 months or less are classified as short-term leases and are not recorded on the balance sheet. The lease expense for short-term leases is recognized on a straight-line basis over the lease term. The Company tests for impairment of the ROU assets whenever circumstances indicate that the carrying amount of the asset may not be recoverable. Common Stock Warrants Freestanding warrants that are related to the purchase of common stock are classified as liabilities and recorded at fair value regardless of the timing of the redemption feature or the redemption price or the likelihood of redemption. These warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants. The warrants are classified as Level 3 liabilities. The value of these warrants was immaterial as of December 31, 2019 and 2018. In addition, in connection with entering into loan agreements, the Company has issued warrants to purchase shares of the Company’s common stock. These detachable warrant instruments qualify for equity classification and have been allocated upon the relative fair value of the base instrument and the warrant. See Note 6 and Note 7 for additional information. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the chief executive officer. The Company and the chief executive officer view the Company’s operations and manage its business as one operating segment. All long-lived assets of the Company reside in the United States. Revenue ASC 605 Revenue Prior to the adoption of FASB’S ASC 606 effective January 2018, the Company recognized revenue under FASB’s ASC 605. Under ASC 605, the Company recognized collaboration revenue when persuasive evidence of an arrangement existed, delivery had occurred or services had been rendered, the price was fixed and determinable, and collectability was reasonably assured. ASC 606 Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers, or ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (i) (ii) (iii) (iv) (v) The Company applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s balance sheet. Amounts expected to be recognized as revenue within the twelve months following the balance sheet date are classified as Current portion of deferred revenue. Amounts not expected to be recognized as revenue within the twelve months following the balance sheet date are classified as Deferred revenue, net of current portion. As of December 31, 2019 and 2018, the Company did not have a deferred revenue balance. License Revenues The Company’s revenues have primarily been generated through licensing arrangements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, up-front license fees; regulatory and commercial milestone payments; payments for manufacturing supply services; materials shipped to support development; and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. See Note 9 for additional details surrounding the Company’s licensing arrangements. The Company also assesses whether there is an option in a contract to acquire additional goods or services. An option gives rise to a performance obligation only if the option provides a material right to the customer that it would not receive without entering into that contract. Factors that the Company considers in evaluating whether an option represents a material right include, but are not limited to: (i) the overall objective of the arrangement, (ii) the benefit the collaborator might obtain from the arrangement without exercising the option, (iii) the cost to exercise the option (e.g. priced at a significant and incremental discount) and (iv) the likelihood that the option will be exercised. With respect to options determined to be performance obligations, the Company recognizes revenue when those future goods or services are transferred or when the options expire. The Company’s revenue arrangements may include the following: Up-front License Fees : If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : At the inception of an agreement that includes regulatory or commercial milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting period, the Company assesses the probability of achievement of each milestone under its current agreements. Research and Development Activities : Under the Company’s current collaboration and license arrangements, if the Company is entitled to reimbursement for costs for services provided by the Company, it expects such reimbursement would be an offset to research and development expenses. Royalties : If the Company is entitled to receive sales-based royalties from its collaborator, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Manufacturing Supply and Research Services : Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company receives payments from its licensees based on schedules established in each contract. Upfront payments are recorded as deferred revenue upon receipt, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. Research and Development Research and development costs are charged to expense as incurred. Research and development costs include, but are not limited to, personnel expenses, clinical trial supplies, fees for clinical trial services, manufacturing costs, consulting costs, and allocated overhead, including rent, equipment, depreciation, and utilities. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company may account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2019, 2018, and 2017, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Stock‑Based Compensation At December 31, 2019, the Company had two stock‑based compensation plans, which are more fully described in Note 7. The Company has applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation , to account for stock-based compensation for employees. The Company recognizes compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant. The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, incentive stock options, non-qualified stock options, and restricted stock unit awards, may be granted to employees, non-employee directors, and non-employee consultants. The Company also has an inducement plan under which various types of equity-based awards, including non-qualified stock options and restricted stock awards, may be granted to new employees. For stock options granted to employees and directors, the Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values. For restricted stock unit awards to employees, the fair value is based on the closing price of the Company’s common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. For stock awards that vest based on performance conditions (e.g., achievement of certain milestones), expense is recognized when it is probable that the condition will be met. Stock-based compensation expense related to restricted stock units granted to employees is recognized based on the grant-date fair value of each award and recorded as expense over the vesting period using the straight-line method. Forfeitures are recorded as they occur. See Note 7 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black‑Scholes option pricing model, as well as a summary of the stock option activity under the Company’s stock‑based compensation plan for all years presented. Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes , or ASC 740, which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. On December 22, 2017, the U.S. government enacted comprehensive tax legislation informally titled the Tax Cuts and Jobs Act of 2017, or the Tax Act. Additionally, the SEC staff issued SAB 118, which provides guidance on accounting for the effects of the Tax Act. See Note 14. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Comprehensive income (loss) relates to unrealized investment gains or losses on the Company’s marketable securities for all periods presented. Basic and Diluted Net Loss Per Share of Common Stock The Company’s basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per common share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. Because the impact of these items is anti‑dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for all periods presented. Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018-15, Intangibles – Goodwill and Other Internal Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . The amendments in this update align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted this standard beginning in the quarter ending September 30, 2019 and the adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures. In February 2016, the FASB issued ASU 2016‑02, Leases (Topic 842) , which requires lessees to record most leases on their balance sheets and disclose key information about leasing arrangements in an effort to increase transparency and comparability among organizations. The standard is effective for annual periods beginning after December 15, 2018 and interim periods within that reporting period. The Company adopted the standard on January 1, 2019 using a modified retrospective approach. The Company recognized a ROU asset and corresponding lease liability related to its operating leases as of the date of adoption. The Company elected to apply the package of practical expedients which allows entities not to reassess whether contracts are or contain leases, lease classification, and whether initial direct costs qualify for capitalization. The Company elected not to separate lease and non-lease components and will not apply the hindsight practical expedient. The adoption of this standard resulted in recording additional net lease assets and lease liabilities of approximately $5.7 million and $8.8 million, respectively. The standard did not materially impact the Company’s net earnings and had no impact on cash flows. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers . ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer in an amount reflecting the consideration it expects to receive in exchange for those goods or services. Additionally, in March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers, Principal versus Agent Considerations . ASU 2016-08 amends the principal versus agent guidance in ASU 2014-09 to clarify how an entity should identify the unit of accounting for the principal versus agent evaluation and how it should apply the control principal to certain types of arrangements. The effective date for both standards is January 1, 2018. The Company adopted these standards on January 1, 2018 and elected the modified retrospective transition method, meaning the cumulative effect of applying the new guidance, if any, was recognized at that date as an adjustment to the opening accumulated deficit balance. There was no impact on the Company’s financial statements upon adoption, as the Company did not have any contracts with customers as of the adoption date. Recent Accounting Standards Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes , which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The guidance is effective for the Company beginning in the first quarter of fiscal year 2021. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement . The new guidance modifies the disclosure requirements related to fair value measurements in Topic 820, Fair Value Measurement , including removing certain previous disclosure requirements, adding certain new disclosure requirements, and modifying certain other disclosure requirements. The ASU will be effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurement, or ASC 820, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Cash, Cash Equivalents, Restricted Cash, and Marketable Securities The following table presents the Company’s cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2019 and 2018 (in thousands): December 31, 2019 Adjusted Unrealized Unrealized Cash and Cash Restricted Marketable Cost Gains Losses Fair Value Equivalents Cash Securities Cash $ 9,302 $ — $ — $ 9,302 $ 7,993 $ 1,309 $ — Level 1 (1): Money market funds 18,306 — — 18,306 18,306 — — U.S. treasury securities 5,996 — — 5,996 2,496 — 3,500 Subtotal 24,302 — — 24,302 20,802 — 3,500 Level 2 (2): U.S. government agency securities 3,510 — — 3,510 3,510 — — Total $ 37,114 $ — $ — $ 37,114 $ 32,305 $ 1,309 $ 3,500 December 31, 2018 Adjusted Unrealized Unrealized Cash and Cash Restricted Marketable Cost Gains Losses Fair Value Equivalents Cash Securities Cash $ 10,992 $ — $ — $ 10,992 $ 9,689 $ 1,303 $ — Level 1 (1): Money market funds 23,203 — — 23,203 23,203 — — U.S. treasury securities 18,938 — (4) 18,934 — — 18,934 Subtotal 42,141 — (4) 42,137 23,203 — 18,934 Level 2 (2): U.S. government agency securities 9,661 — (5) 9,656 — — 9,656 Total $ 62,794 $ — $ (9) $ 62,785 $ 32,892 $ 1,303 $ 28,590 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. (2) The fair value of Level 2 securities is estimated based on observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term on the assets or liabilities. The Company classifies investments available to fund current operations as current assets on its balance sheets. As of December 31, 2019, the Company did not hold any investment securities exceeding a one-year maturity. The Company maintains $1.3 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. Unrealized gains and losses on marketable securities are recorded as a separate component of accumulated other comprehensive income (loss) included in stockholders’ equity. Realized gains (losses) are included in interest income (expense) in the statement of operations and comprehensive income (loss) on a specific identification basis. The Company did not record any realized gains or losses on marketable securities during the years ended December 31, 2019 and 2018. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value. Accretion of bond discount on marketable securities is included in other income as a separate component of other income (expense) on the statement of operations and comprehensive loss. Interest income on marketable securities is recorded as interest income on the statement of operations and comprehensive loss. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. The Company does not hold material Level 3 securities, and therefore, there were no transfers in or out of Level 3 in the hierarchy during the years ended December 31, 2019 or 2018. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment, net | |
Property and Equipment, net | 4. Property and Equipment, net Property and equipment consisted of the following (in thousands): Estimated Useful December 31, Life in Years 2019 2018 Computers and software 3 - 5 $ 480 $ 752 Office equipment and furniture 5 706 832 Manufacturing equipment 5 10 242 Leasehold improvements 10 3,082 3,082 Leased assets 5 45 59 Total property and equipment 4,323 4,967 Less accumulated depreciation and amortization (1,618) (1,580) Property and equipment, net $ 2,705 $ 3,387 Depreciation and amortization expense was $0.6 million, $0.6 million, and $0.5 million for the years ended December 31, 2019, 2018 and 2017, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2019 2018 Compensation and benefits $ 1,786 $ 1,524 Restructuring (severance) — 1,419 Pharmaceutical development expenses 445 231 Accrued interest 18 88 Other accrued expenses and other current liabilities 154 33 Total accrued expenses and other current liabilities $ 2,403 $ 3,295 |
Loans Payable
Loans Payable | 12 Months Ended |
Dec. 31, 2019 | |
Loans Payable | |
Loans Payable | 6. Loans Payable In September 2014, the Company entered into a loan and security agreement with Oxford Finance LLC and Pacific Western Bank (formerly Square 1Bank) (together, the lenders), pursuant to which the lenders agreed to lend the Company up to $35.0 million in a three-tranche series of term loans (Term Loans A, B, and C), collectively, the Term Loans. Upon initially entering into the agreement, the Company borrowed $2.0 million under Term Loan A. In April 2015, the Company amended the agreement with the lenders to change the draw period for Term Loan B. In December 2015, the Company further amended the agreement with the lenders to, among other things, change the draw period for Term Loan C, modify the interest only period, and modify the maturity date of the loan. In December 2015, the Company borrowed the Term Loan B tranche of $16.5 million. The Company’s ability to draw an additional $16.5 million under Term Loan C was subject to the satisfaction of one or more specified triggers related to the results of the Company’s Phase 2b clinical trial of TRV027, which were announced in May 2016. Although those triggers were not attained, in December 2016, the Company and the lenders modified the terms and conditions under which the Company could exercise an option to draw $10.0 million of Term Loan C. In March 2017, the Company borrowed the Term Loan C tranche of $10.0 million. As of December 31, 2019, borrowings under Term Loans A and B accrued interest at a fixed rate of 6.50% per annum and borrowings under Term Loan C accrued interest at a fixed rate of 6.98% per annum. The Company was required to make payments of interest only on borrowings under the loan agreement on a monthly basis through and including January 1, 2018. Payments of principal in equal monthly installments and accrued interest began on January 1, 2018 and continued to be due through December 31, 2019, and until the maturity date of March 1, 2020. As of December 31, 2019, there was $3.2 million aggregate principal balance outstanding under the Term Loans. Upon the last payment date of the amounts borrowed under the agreement, the Company will be required to pay a final payment fee equal to 6.6% of the aggregate amounts borrowed, which is recorded as interest expense over the term of the loans payable. In addition, if the Company repays Term Loan A, Term Loan B, or Term Loan C prior to the maturity date, it will pay the lenders a prepayment fee of 1.0% of Term Loan C. As of December 31, 2019, the Company’s obligations under the loan and security agreement were secured by a first priority security interest in substantially all of the assets of the Company, including the Company’s cash, cash equivalents, and marketable securities but excluding the Company’s intellectual property (collectively, the collateral). The Company agreed not to pledge or otherwise encumber its intellectual property, other than through grants of certain permitted non-exclusive or exclusive licenses or other conveyances of its intellectual property. As of December 31, 2019, the loan and security agreement includes affirmative and restrictive covenants, including: (a) financial reporting requirements; (b) limitations on the incurrence of indebtedness; (c) limitations on liens; (d) limitations on certain merger and acquisition transactions; (e) limitations on dispositions of certain assets; (f) limitations on fundamental corporate changes (including changes in control); (g) limitations on investments; (h) limitations on payments and distributions and (i) other covenants. The agreement also contained certain events of default, including for payment defaults, breaches of covenants, a material adverse change in the Company’s business, operations or condition (financial or otherwise), a material impairment in the value of the collateral or in the prospect of repayment of the Company’s obligations to the lender, certain levies, attachments and other restraints on the Company’s business, insolvency, defaults under other agreements and misrepresentations. As of December 31, 2019, under the agreement, upon an event of default, the lenders had the right to foreclose upon the available collateral, including the Company’s existing cash and cash equivalents and marketable securities. In connection with entering into the loan and security agreement, the Company issued to the lenders and the placement agent warrants to purchase an aggregate of 7,678 shares of Trevena common stock, of which 5,728 shares remain outstanding as of December 31, 2019. These detachable warrant instruments have qualified for equity classification and have been allocated upon the relative fair value of the base instrument and the warrants, according to the guidance of ASC 470‑20‑25‑2. These warrants are exercisable immediately and have an exercise price of $5.8610 per share. The warrants may be exercised on a cashless basis and will terminate on the earlier of September 19, 2024 or the closing of a merger or consolidation transaction in which the Company is not the surviving entity. In connection with the draw of Term Loan B, the Company issued to the lenders and the placement agent additional warrants to purchase an aggregate of 34,961 shares of Trevena common stock. These warrants have substantially the same terms as those noted above, have an exercise price of $10.6190 per share and an expiration date of December 23, 2025. In connection with draw of Term Loan C, the Company issued to the lenders and placement agent additional warrants to purchase an aggregate of 62,241 shares of its common stock. These warrants have substantially the same terms as those noted above, and have an exercise price of $3.6150 per share and an expiration date of March 31, 2027. As of December 31, 2019, borrowings of $3.2 million attributable to Term Loans A, B and C are outstanding. Interest expense of $0.6 million, $1.4 million and $1.7 million was recorded during the years ended December 31, 2019, 2018 and 2017, respectively. The Company incurred lender and third-party costs of $1.0 million, related to the issuance of its term loans. Per ASU 2015‑03, Interest-Imputation of Interest , debt discount and debt issuance costs are to be presented as a contra-liability to the debt on the balance sheet. These costs will be amortized to interest expense over the life of the loans using the effective interest method. A total of $0.1 million, $0.2 million and $0.3 million of debt discount and debt issuance costs were amortized to interest expense during the years ended December 31, 2019, 2018, and 2017, respectively. The following table summarizes how the issuance of Term Loans A, B, and C are reflected on the balance sheet at December 31, 2019 and 2018 (in thousands): December 31, December 31, 2019 2018 Gross proceeds $ 3,167 $ 15,833 Debt discount and debt issuance costs (1) 1,870 1,540 Carrying value 5,037 17,373 Current portion of loans payable, net 5,037 12,562 Loans payable, net $ — $ 4,811 (1) Includes the final fee payment due upon last payment date of the amounts borrowed. Aggregate maturities of long-term debt as of December 31, 2019 are as follows (in thousands): 2020 (1) $ 3,167 2021 — 2022 — 2023 — 2024 — $ 3,167 Debt Discount and deferred financing costs (4) $ 3,163 (1) Excludes the final fee payment of $1.9 million due upon last payment date of the amounts borrowed. On March 1, 2020, the Company repaid the Term Loans in full. See Note 17 for additional information. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | 7. Stockholders’ Equity Equity Offerings ATM Programs Under its certificate of incorporation, the Company was authorized to issue up to 200,000,000 shares of common stock as of December 31, 2019 and December 31, 2018. The Company also was authorized to issue up to 5,000,000 shares of preferred stock as of each of December 31, 2019 and December 31, 2018. The Company is required, at all times, to reserve and keep available out of its authorized but unissued shares of common stock sufficient shares to effect the conversion of the shares of the preferred stock and all outstanding stock options and warrants. On December 14, 2015, the Company entered into an at-the-market, or ATM, sales agreement with Cowen and Company, LLC, or Cowen, to offer and sell, from time to time at the Company’s sole discretion, shares of its common stock, having an aggregate offering price of up to $75.0 million through Cowen as its sales agent, or the First ATM Program. Sales under the First ATM Program were deemed to be “at-the-market offerings,” as defined in Rule 415 under the Securities Act of 1933, as amended, or the Securities Act. Under the First ATM Program, the Company was required to pay Cowen a commission of up to three percent of the gross sales proceeds and provided Cowen with customary indemnification rights. In 2018, the Company issued and sold 11.4 million shares of common stock under the First ATM Program. The net offering proceeds to the Company in 2018 for sales under the First ATM Program were approximately $20.0 million after deducting related expenses, including commissions. Sales of common stock under the First ATM Program terminated on June 29, 2018 when the Company’s Registration Statement on Form S-3 (File No. 333-225685) was declared effective by the SEC. Accordingly, as of December 31, 2019, there was no remaining capacity available under this ATM facility. In June 2018, the Company filed a $175.0 million shelf registration statement on Form S-3 (File No. 333-225685), or the Shelf Registration Statement, that included an ATM sales facility to offer and sell, through Cowen, from time to time at the Company’s sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million, or the Second ATM Program. Sales of the shares are deemed to be “at-the-market offerings,” as defined in Rule 415 under the Securities Act. During 2018, the Company sold approximately 8.5 million shares of its common stock under the Second ATM Program, which yielded net proceeds to the Company of approximately $13.2 million after deducting related expenses, including commissions. The Company terminated sales under the Second ATM Program on April 17, 2019, and the remaining capacity was added back to the aggregate amount available under the Shelf Registration Statement. Accordingly, as of December 31, 2019, there was no remaining capacity available under the Second ATM Program. On April 17, 2019, the Company entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC, or Wainwright, pursuant to which the Company may offer and sell through Wainwright, from time to time at the Company’s sole discretion, shares of its common stock, having an aggregate offering price of up to $50.0 million, or the HCW ATM Program. Sales of the shares of common stock are deemed to be “at-the-market offerings,” as defined in Rule 415 under the Securities Act. The Company intends to use the net proceeds from the offering primarily for the development of its lead product candidate, oliceridine, and for general corporate purposes. In 2019, the Company issued and sold approximately 1.4 million shares of common stock under the HCW ATM Program. The net offering proceeds to the Company in 2019 for sales under the HCW ATM Program were approximately $1.1 million after deducting related expenses, including commissions. As of December 31, 2019, there was approximately $48.9 million remaining available for future issuances under the HCW ATM Program. Registered Direct Offering and Concurrent Warrant Issuance On January 29, 2019, the Company entered into securities purchase agreements with two institutional investors wherein the Company agreed to sell to the investors an aggregate of 10,000,000 shares of its common stock, at an offering price of $1.00 per share, in a registered direct offering made pursuant to the Registration Statement. The net proceeds to the Company from the offering were approximately $9.2 million, after deducting fees and the expenses of the placement agent. Pursuant to a letter agreement dated January 28, 2019, the Company engaged Wainwright to act as its exclusive placement agent in connection with the issuance and sale of the shares. The Company paid Wainwright 7.0% of the aggregate gross proceeds in the offering and $50,000 for certain expenses, and it issued warrants to purchase 500,000 shares of common stock to certain designees of Wainwright. These warrants have a term of five years, are immediately exercisable and have an exercise price of $1.25 per share. The warrants are classified as equity and recorded at fair value as of the date of issuance and no further adjustments to their valuation are made. The letter agreement also includes indemnification obligations of the Company and other provisions customary for transactions of this nature. Equity Incentive Plans In 2008, the Company adopted the 2008 Equity Incentive Plan, as amended on February 29, 2008, January 7, 2010, July 8, 2010, December 10, 2010, June 23, 2011 and June 17, 2013, collectively, the 2008 Plan, that authorized the Company to grant restricted stock and stock options to eligible employees, directors and consultants to the Company. In 2013, the Company adopted the 2013 Equity Incentive Plan, as amended on May 14, 2014, collectively, 2013 Plan. The 2013 Plan became effective upon the Company’s entry into the underwriting agreement related to its IPO in January 2014 and, as of such date, no further grants were permitted under the 2008 Plan. The 2013 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company. Additionally, the 2013 Plan provides for the grant of cash and stock-based performance awards. The 2013 Plan contains an “evergreen” provision, pursuant to which the number of shares of common stock available for issuance under the plan automatically increases on January 1 of each year beginning in 2015. On December 15, 2016, the Company adopted the Trevena, Inc. Inducement Plan, or the Inducement Plan, effective January 1, 2017, pursuant to which the Company reserved 500,000 shares of the Company’s common stock for issuance under the Inducement Plan. The Plan provides for nonstatutory stock options and restricted stock unit awards. The only persons eligible to receive grants of awards under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) and the related guidance under Nasdaq IM 5635‑1, including individuals who were not previously an employee or director of the Company or are following a bona fide period of non-employment, in each case as an inducement material to such individual’s agreement to enter into employment with the Company. Under all Plans, the amount, terms of grants and exercisability provisions are determined by the board of directors or its designee. The term of the options may be up to 10 years, and options are exercisable in cash or as otherwise determined by the board of directors or its designee. Vesting generally occurs over a period of not greater than four years. For performance-based stock awards, the Company recognizes expense when achievement of the performance factor is probable, over the requisite service period. The estimated grant‑date fair value of the Company’s share‑based awards is amortized on a straight-line basis over the awards’ service periods. Share‑based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2019 2018 2017 Research and development $ 825 $ 1,077 $ 1,954 General and administrative 2,407 3,290 4,433 Total stock-based compensation $ 3,232 $ 4,367 $ 6,387 Stock Options A summary of stock option activity and related information from December 31, 2017 through December 31, 2019 follows: Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2017 8,624,223 $ 5.22 7.17 Granted 4,065,375 1.70 Exercised (132,952) 0.63 Forfeited/Cancelled (4,291,439) (4.38) Balance, December 31, 2018 8,265,207 $ 3.99 6.99 Granted 1,033,000 1.10 Exercised (41,968) 0.68 Forfeited/Cancelled (1,687,935) (4.94) Balance, December 31, 2019 7,568,304 $ 3.40 7.01 Vested or expected to vest at December 31, 2019 7,568,304 $ 3.40 7.01 Exercisable at December 31, 2019 4,259,251 $ 4.24 5.92 The intrinsic value of the options exercisable as of December 31, 2019 was $0.1 million, based on the Company’s closing stock price of $0.84 per share and a weighted average exercise price of $4.24 per share. On February 28, 2018, the Company granted 1,803,625 stock options to employees. The awards vest 50% upon the date on which FDA approves the Company’s new drug application for OLINVO injection, and the remaining 50% vest annually over a 4-year period beginning on the grant date. No compensation expense has been recognized for the awards which vest upon FDA approval as these shares are performance based and the triggering event was not determined to be probable as of December 31, 2019. As of December 31, 2019 and 2018, the total unrecognized compensation expense related to the nonvested and nonforfeited shares was $0.1 million. The Company uses the Black‑Scholes option‑pricing model to estimate the fair value of stock options at the grant date. The Black‑Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s common stock, assumptions related to the expected price volatility of the Company’s stock, the period during which the options will be outstanding, the rate of return on risk‑free investments and the expected dividend yield for the Company’s stock. The per-share weighted average grant date fair value of the options granted to employees and directors during the year ended December 31, 2019, 2018 and 2017 was estimated at $0.86, $1.13 and $2.68 per share, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions: Year Ended December 31, 2019 2018 2017 Expected term of options (in years) 6.1 5.8 6.2 Risk-free interest rate 1.9 % 2.8 % 2.0 % Expected volatility 98.9 % 71.7 % 75.6 % Dividend yield — % — % — % The weighted average valuation assumptions were determined as follows: · Risk‑free interest rate: The Company based the risk‑free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. · Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected life of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. · Expected stock price volatility: The Company estimates the expected volatility based on the actual historical volatility of the Company’s stock price using daily closing prices over a period of the expected term of the associated award. Prior to January 1, 2018, the Company estimated the expected volatility based on actual historical volatility of the stock price of similar companies with publicly‑traded equity securities. · Expected annual dividend yield: The Company estimated the expected dividend yield based on consideration of its historical dividend experience and future dividend expectations. The Company has not historically declared or paid dividends to stockholders. Moreover, it does not intend to pay dividends in the future, but instead expects to retain any earnings to invest in the continued growth of the business. Accordingly, the Company assumed an expected dividend yield of 0.0%. · Estimated forfeiture rate: The Company elected to record forfeitures upon occurrence, rather than utilizing an estimate. As of December 31, 2019, there was $2.9 million of total unrecognized compensation expense related to unvested stock options that will be recognized over the weighted average remaining period of 1.94 years. Restricted Stock Units On December 5, 2019, the Company granted 2,170,585 restricted stock units, or RSUs, to employees. The units vest subject to the satisfaction of service requirements as follows: 50% vest on December 5, 2020, and 50% vest on December 5, 2021. The fair market value per RSU is $0.72, which is equal to the closing price of the Company’s common stock on the date of the grant. On December 6, 2018, the Company granted 1,255,000 RSUs to employees. The units vest subject to the satisfaction of service requirements as follows: 25% vested on June 1, 2019, 25% vested on December 1, 2019, and the remaining vest on December 6, 2020. The fair market value per RSU is $0.65, which is equal to the closing price of the Company’s common stock on the date of the grant. RSU-related expense is recognized on a straight-line basis over the vesting period. Upon vesting, these awards may be settled on a net-exercise basis to cover any required withholding tax with the remaining amount converted into an equivalent number of shares of common stock. There were 166,407 shares of common stock underlying vested RSUs that were withheld during the year ended December 31, 2019, based on the value of the RSU awards as determined by the Company’s closing stock price on the applicable vesting date. The shares withheld for taxes are again available for issuance under the plan. The following is a summary of changes in the status of non-vested RSUs: Weighted Average Number of Grant Date Awards Fair Value Non-vested at December 31, 2017 — $ — Granted 1,255,000 0.65 Exercised — — Forfeited/Cancelled — — Non-vested at December 31, 2018 1,255,000 $ 0.65 Granted 2,500,585 0.74 Vested (572,500) 0.65 Forfeited (237,500) 0.65 Non-vested at December 31, 2019 2,945,585 $ 0.73 For the years ended December 31, 2019 and 2018, the Company recorded $0.5 million and less than $0.1 million, respectively, in stock-based compensation expense related to RSUs, which is reflected in the statements of operations and comprehensive loss. As of December 31, 2019, there was $2.0 million of total unrecognized compensation expense related to unvested RSUs that will be recognized over the weighted average remaining period of 1.96 years. Shares Available for Future Grant At December 31, 2019, the Company has the following shares available to be granted: Inducement 2013 Plan Plan Available at December 31, 2018 2,603,983 144,125 Authorized 3,459,343 — Granted (3,533,585) — Forfeited/Cancelled 1,864,560 60,875 Available at December 31, 2019 4,394,301 205,000 Shares Reserved for Future Issuance At December 31, 2019, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 7,273,304 Restricted stock units outstanding under 2013 Plan 2,945,585 Shares reserved for future issuance under 2013 Plan 4,394,301 Stock options outstanding under Inducement Plan 295,000 Shares reserved for future issuance under Inducement Plan 205,000 Shares reserved for future issuance under 2013 Employee Stock Purchase Plan 225,806 Warrants outstanding 623,091 Total shares of common stock reserved for future issuance 15,962,087 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 8. Commitments and Contingencies Leases The Company leases office space in Chesterbrook, Pennsylvania and equipment. The Company’s principal office is located at 955 Chesterbrook Boulevard, Chesterbrook, Pennsylvania, where the Company currently leases approximately 8,231 square feet of developed office space on the first floor and 40,565 square feet of developed office space on the second floor. The lease term for this space extends through May 2028. On October 11, 2018, the Company entered into an agreement with The Vanguard Group, Inc., or Vanguard, whereby Vanguard agreed to sublease the 40,565 square feet of space on the second floor for an initial term of 37 months. Vanguard has an option to extend the sublease term for 3 years, and a second option to extend the sublease until November 30, 2027. The sublease provides for rent abatement for the first month of the term; thereafter, the rent payable to the Company by Vanguard under the sublease is (i) $0.50 less during months 2 through 13 of the sublease and (ii) in month 14 and thereafter of the sublease, $1.00 less than the base rent payable by the Company under its master lease with Chesterbrook Partners, L.P. Vanguard also is responsible for paying to the Company all tenant energy costs, annual operating costs, and annual tax costs attributable to the subleased space during the term of the sublease. Rent expense and associated sublease income are recorded in the Company’s statements of operations and comprehensive loss as other income (expense). In October 2017, the Company terminated its lease related to vivarium space in Exton, Pennsylvania, under an agreement expiring on December 31, 2018. The Company incurred termination fees equivalent to three months’ rent, totaling less than $0.1 million, in relation to the early termination of this agreement. Additionally, in November 2017, the Company provided notice of its intent to terminate its facility lease of approximately 16,714 square feet of office and laboratory space in King of Prussia, Pennsylvania, under an agreement that expires in September 2020. The Company paid the landlord a $0.15 million termination fee on the date the Company exercised the termination option. This lease was deemed terminated on August 15, 2018. Supplemental balance sheet information related to leases was as follows (in thousands): December 31, 2019 December 31, 2018 Operating leases: Operating lease right-of-use assets $ 5,472 $ — Other current liabilities 611 — Operating lease liabilities 7,793 — Total operating lease liabilities $ 8,404 $ — Finance leases: Property and equipment, at cost $ 45 $ 59 Accumulated depreciation (25) (29) Property and equipment, net 20 30 Other current liabilities 9 10 Other long-term liabilities 11 20 Total finance lease liabilities $ 20 $ 30 The components of lease expense were as follows (in thousands): Year Ended December 31, 2019 2018 2017 Operating lease costs: Operating lease rental expense $ 1,187 $ 1,532 $ 1,355 Other income (1,263) (139) — Total operating lease costs $ (76) $ 1,393 $ 1,355 Finance lease costs: Amortization of right-of-use assets $ $ $ Interest on lease liabilities 2 3 2 Total finance lease costs $ 13 $ 15 $ 10 Supplemental cash flow information related to leases was as follows (in thousands): Year Ended December 31, 2019 2018 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (167) $ (1,393) Operating cash flows from finance leases — — Financing cash flows from finance leases (12) (14) Our operating lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2020 $ 1,352 $ 10 2021 1,376 8 2022 1,401 4 2023 1,425 — 2024 and beyond 6,586 — Total minimum lease payments $ 12,140 $ 22 Interest Expense (3,736) (2) Lease liability $ 8,404 $ 20 Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2020 $ 1,078 2021 943 2022 — 2023 — 2024 and beyond — Total minimum lease payments $ 2,021 Weighted average lease term and discount rates are as follows: Year Ended December 31, 2019 2018 Weighted average remaining lease term (years) Operating leases 8 9 Finance leases 2 2 Weighted average discount rate Operating leases Finance leases The Company had no deferred rent at December 31, 2019, and had deferred rent of $3.1 million at December 31, 2018 and 2017 related to its facility leases. Legal Proceedings In October and November 2018, the Company and certain current and former officers and directors were sued in three purported class actions filed in the U.S. District Court for the Eastern District of Pennsylvania, or the EDPA, alleging violations of the federal securities laws. In January 2019, the three lawsuits were consolidated into one action, and on May 29, 2019, the District Court appointed a group of five individual investors as lead plaintiffs. A consolidated amended complaint was filed on August 2, 2019, alleging, among other things, that the Company and two former officers made false and misleading statements regarding the Company’s business, operations, and prospects, including certain statements made relating to the Company’s End-of-Phase 2 meeting with the FDA, and certain statements concerning top-line results from the Company’s Phase 3 studies. The plaintiffs seek, among other remedies, unspecified damages, attorneys’ fees and other costs, and unspecified equitable or injunctive relief. The Company believes that the claims are without merit, and the Company intends to vigorously defend itself against the allegations. On October 2, 2019, the Company moved to dismiss the consolidated amended complaint on the basis that there were no false statements and no scienter as a matter of law. In December 2018, a shareholder derivative action was filed on behalf of the Company and against certain current and former officers and directors in the EDPA, and in February 2019, two additional, similar shareholder derivative actions were filed in the U.S. District Court for the District of Delaware. A fourth similar shareholder derivative action was filed in the EDPA in September 2019, and a fifth, similar derivative action was filed in the EDPA in November 2019. These cases, which involve facts similar to the consolidated securities lawsuits, assert claims against the individual defendants for, among other things, breach of fiduciary duty, waste of corporate assets, violations of the federal securities laws, and unjust enrichment, and they make a number of demands, including for monetary damages and other equitable and injunctive relief. The derivative actions have been stayed in favor of the consolidated securities lawsuits. |
Licensing Arrangements
Licensing Arrangements | 12 Months Ended |
Dec. 31, 2019 | |
Licensing Arrangements | |
Licensing Arrangements | 9. Licensing Arrangements License and Commercialization Agreement with Pharmbio Korea Inc. In April 2018, the Company entered into an exclusive license agreement with Pharmbio Korea Inc., or Pharmbio, for the development and commercialization of oliceridine for the management of moderate to severe acute pain in South Korea. Under the terms of the agreement, the Company received an upfront, non-refundable cash payment of $3.0 million (less applicable withholding taxes of $0.5 million) in June 2018, and will receive a cash commercial milestone of up to $0.5 million if oliceridine is approved in South Korea and tiered royalties on product sales in South Korea ranging from high single digits to 20%, less applicable withholding taxes. As part of the agreement, the Company also granted Pharmbio an option to manufacture oliceridine, on a non-exclusive basis, for the development and commercialization of the product in South Korea, subject to a separate arrangement to be entered into if Pharmbio exercises the option. The license agreement is terminable by Pharmbio for any reason upon 180 days written notice. In accordance with the terms of the agreement, Pharmbio is solely responsible for all development and regulatory activities in South Korea. The parties have formed a Joint Development Committee with equal representation from the Company and Pharmbio to provide overall coordination and oversight of the development of oliceridine in South Korea. The parties also agreed to form a Joint Manufacturing and Commercialization Committee at least six months prior to the anticipated date of regulatory approval of oliceridine in South Korea to provide overall coordination and oversight of the manufacture and commercialization of oliceridine in South Korea. See Note 10 for accounting analysis under ASC 606. License Agreement with Jiangsu Nhwa Pharmaceutical Co. Ltd. In April 2018, the Company also entered into an exclusive license agreement with Jiangsu Nhwa Pharmaceutical Co. Ltd., or Nhwa, for the development and commercialization of oliceridine for the management of moderate to severe acute pain in China. Under the terms of this agreement, the Company received an upfront, non-refundable cash payment of $2.5 million (less applicable withholding taxes of $0.3 million) in July 2018, and is eligible to receive cash milestone payments of $3.0 million upon regulatory approval of oliceridine in each of the United States and China, up to an additional $6.0 million of commercialization milestones based on product sales levels in China, and a ten percent royalty on all net product sales in China, less applicable withholding taxes. As part of the agreement, the Company also granted Nhwa an option to manufacture oliceridine, on an exclusive basis in China, for the development and commercialization of the product in China. In the second quarter of 2018, Nhwa elected to exercise this manufacturing option. The license agreement is terminable by Nhwa for any reason upon 180 days written notice. In accordance with the terms of the agreement, Nhwa is solely responsible for all development and regulatory activities in China. The parties have formed a Joint Development Committee with equal representation from the Company and Nhwa to provide overall coordination and oversight of the development of oliceridine in China. The parties also agreed to form a Joint Manufacturing and Commercialization Committee at least six months prior to the anticipated date of regulatory approval of oliceridine in China to provide overall coordination and oversight of the manufacture and commercialization of oliceridine in China. See Note 10 for accounting analysis under ASC 606. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2019 | |
Revenue | |
Revenue | 10 . Revenue The Company accounts for revenue under ASC 606, under which revenue is recognized when, or as, performance obligations under the terms of a contract are satisfied, which occurs when control of the promised products or services is transferred to customers. License Revenue recorded under ASC 606 License revenue for the years ended December 31, 2019 and 2018 represents revenue from contracts with customers in licensing arrangements accounted for in accordance with ASC 606, which the Company adopted in the first quarter of 2018, as more fully described in Note 2 and Note 9. Revenue related to the Pharmbio agreement was recognized in the third quarter of 2018, when the Company satisfied its performance obligation in July 2018. Revenue related to the upfront payments received from Nhwa was recognized in the second quarter of 2018, once the related performance obligation was satisfied in June 2018. Both of these performance obligations were satisfied once the Company had transferred the license and know-how and each party could begin to benefit from the transfer. The Company determined that participation in the Joint Development Committees and Joint Manufacturing and Commercialization Committees were deemed immaterial in the context of the contract. The income tax expense resulting from these transactions represents foreign withholding taxes as a result of license revenue from the contracts. As the Company has incurred losses in recent years, no material U.S. federal, state, or foreign income taxes have been accrued. |
Restructuring Charges
Restructuring Charges | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring Charges | |
Restructuring Charges | 11. Restructuring Charges On November 8, 2018, upon the approval of the Company's Board of Directors, the Company announced a restructuring of approximately one-third of the Company's workforce, or 14 employees, as well as other cost saving initiatives intended to lower the Company's annualized net operating cash burn. The Company completed the restructuring on December 31, 2018. The Company determined that the total costs related to the restructuring were approximately $1.4 million, all of which resulted in future cash outlays, primarily related to severance costs and benefit-related expenses. The Company recorded these charges in the fourth quarter of 2018. The following table summarizes the restructuring balances at December 31, 2019 and 2018 (in thousands): Year Ended December 31, 2019 2018 Balance, January 1 $ 1,419 $ 1,077 Current year restructuring costs — 1,427 Payment of employee severance costs (1,419) (1,085) Balance, December 31 $ — $ 1,419 |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2019 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 12. Net Loss Per Common Share The following table sets forth the computation of basic and diluted net loss per share for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2019 2018 2017 Basic and diluted net loss per common share calculation: Net loss $ (24,871) $ (30,784) $ (71,865) Net loss attributable to common stockholders $ (24,871) $ (30,784) $ (71,865) Weighted average common shares outstanding 91,677,963 73,558,548 59,436,649 Net loss per share of common stock - basic and diluted $ (0.27) $ (0.42) $ (1.21) The following outstanding securities at December 31, 2019, 2018 and 2017 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti‑dilutive: December 31, 2019 2018 2017 Options outstanding 7,568,304 8,265,207 8,624,223 RSUs outstanding 2,945,585 1,255,000 — Warrants 623,091 123,091 123,091 Total 11,136,980 9,643,298 8,747,314 |
Comprehensive Income (Loss)
Comprehensive Income (Loss) | 12 Months Ended |
Dec. 31, 2019 | |
Comprehensive Income (Loss) | |
Comprehensive Income (Loss) | 13. Comprehensive Income (Loss) The following table presents changes in the components of accumulated other comprehensive income or loss, net of tax (in thousands): Balance, January 1, 2018 $ (42) Net unrealized loss arising during the period 33 Balance, December 31, 2018 $ (9) Net unrealized gain on marketable securities 9 Balance, December 31, 2019 $ — There were no reclassifications out of accumulated other comprehensive income or loss as well as no tax effect for all periods presented. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Income Taxes | 14. Income Taxes As the Company has historically incurred net operating losses, the Company has historically not recorded a provision for income taxes. The Company recorded withholding tax of $0.8 million in 2018 but had none in 2019. The Company is also in a full valuation allowance that will offset any potential deferred tax expense or benefit. For the year ended December 31, 2019, the Company’s valuation allowance increased by $9.0 million compared to the prior year period. On December 22, 2017, the U.S. government enacted comprehensive tax legislation, informally titled the Tax Cuts and Jobs Act of 2017, or the Tax Act. The Tax Act makes broad and complex changes to the Code, including, but not limited to, (1) reducing the U.S. federal corporate tax rate to 21 percent; (2) elimination of the corporate alternative minimum tax, or AMT, and changing how existing AMT credits can be realized; (3) a new limitation on deductible interest expense; (4) the repeal of the domestic production activity deduction; (5) creating the base erosion and anti-abuse tax, a new minimum tax; (6) limitation on the deductibility of certain executive compensation; (7) enhancing the option to claim accelerated depreciation deductions on qualified property and (8) limitations on net operating loss carryforwards, or NOLs, generated after December 31, 2017, to 80 percent of taxable income. The income tax provision for the years ended December 31, 2019 and 2018 are as follows (in thousands): December 31, 2019 2018 Current: Federal $ — $ 745 State — — Total — 745 Deferred Federal — — State — — Total — — Total income tax provision (benefit) $ — $ 745 Deferred tax assets and liabilities reflect the net effects of NOLs and tax credit carryovers and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company maintains a full valuation allowance against its net deferred tax assets because significant utilization of such amounts is not presently expected in the foreseeable future. Significant components of the Company’s net deferred tax assets as of December 31, 2019 and 2018 are as follows (in thousands): December 31, 2019 2018 Deferred tax assets: NOLs $ 22,033 $ 18,942 Research and development credits 14,138 13,086 Research and development expenses capitalized for tax purposes 92,350 88,485 Deferred rent 847 321 Depreciation 162 19 Other temporary differences 5,124 4,823 Total deferred tax assets 134,654 125,676 Deferred tax liabilities: Prepaid expenses (86) (64) Total deferred tax liabilities (86) (64) Net deferred tax assets 134,568 125,612 Less valuation allowance (134,568) (125,612) Net deferred tax asset $ — $ — A reconciliation of income tax expense computed at the statutory federal income tax rate to income taxes as reflected in the financial statements is as follows: December 31, 2019 2018 2017 Percent of pre-tax income: U.S. federal statutory income tax rate 21.0 % 21.0 % 34.0 % Permanent Differences — % (0.1) % 0.1 % State taxes, net of federal benefit 8.3 % 7.9 % 6.7 % Research and development credit 3.4 % 2.8 % 1.7 % Rate change due to the Tax Act — % — % (58.5) % Withholding Tax — % (2.4) % — % Other 3.3 % — % 1.0 % Change in valuation allowance (36.0) % (31.6) % 15.0 % Effective income tax rate — % (2.4) % — % As of December 31, 2019, the Company had U.S. federal and state NOLs of $76.7 million and $75.2 million, respectively, that begin to expire starting in 2028. As of December 31, 2019, the Company had federal research and development tax credit carryforwards of $14.1 million that begin to expire in 2028. The Company’s ability to utilize NOLs or tax credit carryforwards may be subject to annual limitations under certain provisions of the Code related to “changes in ownership.” The Company files income tax returns in the U.S. and the Commonwealth of Pennsylvania. Tax years for fiscal 2016 through 2018 are open and potentially subject to examination by the federal and state taxing authorities. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. To the extent the Company utilizes in the future any tax attribute NOLs from a tax period that may otherwise be closed to examination, the Internal Revenue Service, state tax authorities, or other governing parties may still adjust the NOLs upon their examination of the future period in which the attribute was utilized. There are no uncertain tax positions recorded for any federal or state items. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2019 | |
Employee Benefit Plan | |
Employee Benefit Plan | 15. Employee Benefit Plan The Company sponsors a 401(k) defined contribution plan for its employees. Employee contributions are voluntary. The Company matches employee contributions in an amount equal to 100% of the first 3% of eligible compensation and 50% of the next 2% of eligible compensation, and such employer contributions are immediately vested. During the years ended December 31, 2019, 2018 and 2017, the Company provided matching contributions of $0.2 million, $0.4 million and $0.4 million, respectively. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Quarterly Financial Data (Unaudited) | |
Selected Quarterly Financial Data (Unaudited) | 16. Selected Quarterly Financial Data (Unaudited) First Quarter Second Quarter Third Quarter Fourth Quarter (in thousands, except share and per share amounts) 2019 Total revenue $ — $ — $ — $ 31 Loss from operations $ (5,214) $ (6,141) $ (8,755) $ (6,470) Net loss $ (5,169) $ (4,691) $ (8,566) $ (6,445) Net loss per share of common, basic and diluted $ (0.06) $ (0.05) $ (0.09) $ (0.07) Weighted average shares outstanding, basic and diluted 88,897,292 92,414,644 92,569,993 92,777,480 2018 Total revenue $ — $ 2,500 $ 3,000 $ 232 Loss from operations $ (9,693) $ (8,595) $ (4,258) $ (7,951) Net loss $ (9,021) $ (9,304) $ (4,483) $ (7,976) Net loss per share of common, basic and diluted $ (0.14) $ (0.13) $ (0.06) $ (0.10) Weighted average shares outstanding, basic and diluted 64,562,236 69,664,994 77,445,675 82,323,393 The quarters presented above have been adjusted to reflect the immaterial impact of the Company’s election to recognize forfeitures of share-based payment awards as they occur rather than using an estimate. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events | |
Subsequent Events | 17. Subsequent Events Resubmission of NDA In February 2020, the Company resubmitted the NDA for oliceridine based on the topline data from the healthy volunteer QT study and the final minutes of the Type A meeting with the FDA. The resubmission package included data from the healthy volunteer QT study, nonclinical data that confirmed levels of the 9662 metabolite, and drug product validation reports. The resubmission package also specified a maximum daily dose of 27 mg, as previously acknowledged by the FDA in the Type A meeting minutes. In the acknowledgment letter, the FDA stated that the Company’s resubmission was a complete, class 2 response to the CRL. As a result, the FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of August 7, 2020 for the completion of its review of the NDA. Transfer to Nasdaq Capital Market On March 4, 2020, the Company transferred the listing of its common stock to the Nasdaq Capital Market, in order to become eligible for an additional 180-day compliance period provided for companies listed on the Nasdaq Capital Market, provided that the Company meets the continued listing requirements for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price requirement, and provided written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. The Company’s common stock continues to trade under the symbol “TRVN.” On March 3, 2020, the Company received notice from Nasdaq that it was granted an additional 180 days, or until August 31, 2020, to regain compliance with the minimum price requirement. Repayment of Term Loans On March 1, 2020, the Company made its final payment under the loan and security agreement with Oxford Finance LLC and Pacific Western Bank, including a final payment fee of $1.9 million, equal to 6.6% of the aggregate amounts borrowed. The Company is no longer required to make any further payments under the loan and security agreement to Oxford Finance LLC and Pacific Western Bank. Appointment of Executive Officer On February 10, 2020, the board of directors of the Company appointed Scott Applebaum as Chief Legal and Compliance Officer and Senior Vice President of Regulatory Affairs. Mr. Applebaum comes to the Company with over 20 years of experience in a variety of senior leadership roles at both large and small companies at various stages of development and commercialization in the biopharmaceuticals sector. |
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 conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and Accounting Standards Update, or ASU, of FASB. The Company’s functional currency is the U.S. dollar. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of liability-classified common stock warrants, the accounting for research and development costs, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. |
Cash and Cash Equivalents and Marketable Securities | Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents are valued at cost, which approximates their fair market value. The Company maintains a portion of its cash and cash equivalent balances in money market mutual funds that may invest substantially all of their assets in U.S. government agency securities and U.S. Treasury securities. The Company classifies its marketable securities as “available-for-sale,” pursuant to ASC Topic 320, Investments—Debt and Equity Securities , or ASC 320, carries them at fair market value and classifies them as current assets on its balance sheets. Unrealized gains and losses on marketable securities are recorded as a separate component of accumulated other comprehensive income (loss) included in stockholders’ equity. As of December 31, 2019 and 2018, the Company had $3.5 million and $28.6 million, respectively, in available-for-sale investments, all classified as current assets. See Note 3 for additional information. The fair value of the Company’s investments is determined based on observable market quotes or valuation models using assessments of counterparty credit worthiness, credit default risk of underlying security and overall capital market liquidity. The Company reviews unrealized losses associated with available-for-sale securities to determine the classification as “temporary” or “other-than-temporary” impairment. A temporary impairment results in an unrealized loss being recorded in other comprehensive income (loss). If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is transferred from other comprehensive income (loss) to the statement of operations. The Company considers various factors in determining the classification, including the length of time and extent to which the fair value has been less than the Company’s cost basis, the financial condition and near-term prospects of the issuer or investee, and the Company’s ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. Realized gains (losses) are included in interest income (expense) in the statement of operations and comprehensive income (loss) on a specific identification basis. |
Restricted Cash | Restricted Cash The Company maintains $1.3 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, marketable securities, restricted cash, accounts payable and accrued expenses approximate their fair values, given their short-term nature. The carrying amount of the Company’s loans payable at December 31, 2019 and 2018 is the nominal value of the loan payable, net of debt discount and deferred charges. The nominal value approximates fair value because the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, marketable securities and restricted cash. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. |
Property and Equipment | Property and Equipment Property and equipment consists of computer and laboratory equipment, software, office equipment, furniture, manufacturing equipment and leasehold improvements and is recorded at cost. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred. Upon disposal, retirement or sale, the related cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Property and equipment are depreciated on a straight‑line basis over their estimated useful lives. The Company uses a life of three years for computer equipment and five years for laboratory equipment, office equipment, furniture, manufacturing equipment and software. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. The Company reviews long‑lived assets when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses were recorded since inception through December 31, 2018. $0.1 million of impairment losses were recorded during the year ended December 31, 2019. |
Leases | Leases At the commencement of a lease, the Company recognizes a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term, including variable fees that are known or subject to a minimum floor. The lease liability includes lease component fees, while non-lease component fees are expensed as incurred for all asset classes. When a contract excludes an implicit rate, the Company utilizes an incremental borrowing rate based on information available at the lease commencement date including lease term and geographic region. The initial valuation of the right-of-use, or ROU, asset includes the initial measurement of the lease liability, lease payments made in advance of the lease commencement date, and initial direct costs incurred by the Company and excludes lease incentives. Leases with an initial term of 12 months or less are classified as short-term leases and are not recorded on the balance sheet. The lease expense for short-term leases is recognized on a straight-line basis over the lease term. The Company tests for impairment of the ROU assets whenever circumstances indicate that the carrying amount of the asset may not be recoverable. |
Common Stock Warrants | Common Stock Warrants Freestanding warrants that are related to the purchase of common stock are classified as liabilities and recorded at fair value regardless of the timing of the redemption feature or the redemption price or the likelihood of redemption. These warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants. The warrants are classified as Level 3 liabilities. The value of these warrants was immaterial as of December 31, 2019 and 2018. In addition, in connection with entering into loan agreements, the Company has issued warrants to purchase shares of the Company’s common stock. These detachable warrant instruments qualify for equity classification and have been allocated upon the relative fair value of the base instrument and the warrant. See Note 6 and Note 7 for additional information. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the chief executive officer. The Company and the chief executive officer view the Company’s operations and manage its business as one operating segment. All long-lived assets of the Company reside in the United States. |
Revenue | Revenue ASC 605 Revenue Prior to the adoption of FASB’S ASC 606 effective January 2018, the Company recognized revenue under FASB’s ASC 605. Under ASC 605, the Company recognized collaboration revenue when persuasive evidence of an arrangement existed, delivery had occurred or services had been rendered, the price was fixed and determinable, and collectability was reasonably assured. ASC 606 Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers, or ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (i) (ii) (iii) (iv) (v) The Company applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s balance sheet. Amounts expected to be recognized as revenue within the twelve months following the balance sheet date are classified as Current portion of deferred revenue. Amounts not expected to be recognized as revenue within the twelve months following the balance sheet date are classified as Deferred revenue, net of current portion. As of December 31, 2019 and 2018, the Company did not have a deferred revenue balance. License Revenues The Company’s revenues have primarily been generated through licensing arrangements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, up-front license fees; regulatory and commercial milestone payments; payments for manufacturing supply services; materials shipped to support development; and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. See Note 9 for additional details surrounding the Company’s licensing arrangements. The Company also assesses whether there is an option in a contract to acquire additional goods or services. An option gives rise to a performance obligation only if the option provides a material right to the customer that it would not receive without entering into that contract. Factors that the Company considers in evaluating whether an option represents a material right include, but are not limited to: (i) the overall objective of the arrangement, (ii) the benefit the collaborator might obtain from the arrangement without exercising the option, (iii) the cost to exercise the option (e.g. priced at a significant and incremental discount) and (iv) the likelihood that the option will be exercised. With respect to options determined to be performance obligations, the Company recognizes revenue when those future goods or services are transferred or when the options expire. The Company’s revenue arrangements may include the following: Up-front License Fees : If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : At the inception of an agreement that includes regulatory or commercial milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting period, the Company assesses the probability of achievement of each milestone under its current agreements. Research and Development Activities : Under the Company’s current collaboration and license arrangements, if the Company is entitled to reimbursement for costs for services provided by the Company, it expects such reimbursement would be an offset to research and development expenses. Royalties : If the Company is entitled to receive sales-based royalties from its collaborator, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Manufacturing Supply and Research Services : Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company receives payments from its licensees based on schedules established in each contract. Upfront payments are recorded as deferred revenue upon receipt, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. Research and development costs include, but are not limited to, personnel expenses, clinical trial supplies, fees for clinical trial services, manufacturing costs, consulting costs, and allocated overhead, including rent, equipment, depreciation, and utilities. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company may account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2019, 2018, and 2017, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Stock-Based Compensation | Stock‑Based Compensation At December 31, 2019, the Company had two stock‑based compensation plans, which are more fully described in Note 7. The Company has applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation , to account for stock-based compensation for employees. The Company recognizes compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant. The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, incentive stock options, non-qualified stock options, and restricted stock unit awards, may be granted to employees, non-employee directors, and non-employee consultants. The Company also has an inducement plan under which various types of equity-based awards, including non-qualified stock options and restricted stock awards, may be granted to new employees. For stock options granted to employees and directors, the Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values. For restricted stock unit awards to employees, the fair value is based on the closing price of the Company’s common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. For stock awards that vest based on performance conditions (e.g., achievement of certain milestones), expense is recognized when it is probable that the condition will be met. Stock-based compensation expense related to restricted stock units granted to employees is recognized based on the grant-date fair value of each award and recorded as expense over the vesting period using the straight-line method. Forfeitures are recorded as they occur. See Note 7 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black‑Scholes option pricing model, as well as a summary of the stock option activity under the Company’s stock‑based compensation plan for all years presented. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes , or ASC 740, which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. On December 22, 2017, the U.S. government enacted comprehensive tax legislation informally titled the Tax Cuts and Jobs Act of 2017, or the Tax Act. Additionally, the SEC staff issued SAB 118, which provides guidance on accounting for the effects of the Tax Act. See Note 14. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Comprehensive income (loss) relates to unrealized investment gains or losses on the Company’s marketable securities for all periods presented. |
Basic and Diluted Net Loss Per Share of Common Stock | Basic and Diluted Net Loss Per Share of Common Stock The Company’s basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per common share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. Because the impact of these items is anti‑dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for all periods presented. |
Recent Accounting Pronouncements | Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018-15, Intangibles – Goodwill and Other Internal Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . The amendments in this update align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted this standard beginning in the quarter ending September 30, 2019 and the adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures. In February 2016, the FASB issued ASU 2016‑02, Leases (Topic 842) , which requires lessees to record most leases on their balance sheets and disclose key information about leasing arrangements in an effort to increase transparency and comparability among organizations. The standard is effective for annual periods beginning after December 15, 2018 and interim periods within that reporting period. The Company adopted the standard on January 1, 2019 using a modified retrospective approach. The Company recognized a ROU asset and corresponding lease liability related to its operating leases as of the date of adoption. The Company elected to apply the package of practical expedients which allows entities not to reassess whether contracts are or contain leases, lease classification, and whether initial direct costs qualify for capitalization. The Company elected not to separate lease and non-lease components and will not apply the hindsight practical expedient. The adoption of this standard resulted in recording additional net lease assets and lease liabilities of approximately $5.7 million and $8.8 million, respectively. The standard did not materially impact the Company’s net earnings and had no impact on cash flows. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers . ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer in an amount reflecting the consideration it expects to receive in exchange for those goods or services. Additionally, in March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers, Principal versus Agent Considerations . ASU 2016-08 amends the principal versus agent guidance in ASU 2014-09 to clarify how an entity should identify the unit of accounting for the principal versus agent evaluation and how it should apply the control principal to certain types of arrangements. The effective date for both standards is January 1, 2018. The Company adopted these standards on January 1, 2018 and elected the modified retrospective transition method, meaning the cumulative effect of applying the new guidance, if any, was recognized at that date as an adjustment to the opening accumulated deficit balance. There was no impact on the Company’s financial statements upon adoption, as the Company did not have any contracts with customers as of the adoption date. Recent Accounting Standards Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes , which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The guidance is effective for the Company beginning in the first quarter of fiscal year 2021. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement . The new guidance modifies the disclosure requirements related to fair value measurements in Topic 820, Fair Value Measurement , including removing certain previous disclosure requirements, adding certain new disclosure requirements, and modifying certain other disclosure requirements. The ASU will be effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value of Financial Instruments | |
Schedule of cash, cash equivalents and marketable securities | The following table presents the Company’s cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2019 and 2018 (in thousands): December 31, 2019 Adjusted Unrealized Unrealized Cash and Cash Restricted Marketable Cost Gains Losses Fair Value Equivalents Cash Securities Cash $ 9,302 $ — $ — $ 9,302 $ 7,993 $ 1,309 $ — Level 1 (1): Money market funds 18,306 — — 18,306 18,306 — — U.S. treasury securities 5,996 — — 5,996 2,496 — 3,500 Subtotal 24,302 — — 24,302 20,802 — 3,500 Level 2 (2): U.S. government agency securities 3,510 — — 3,510 3,510 — — Total $ 37,114 $ — $ — $ 37,114 $ 32,305 $ 1,309 $ 3,500 December 31, 2018 Adjusted Unrealized Unrealized Cash and Cash Restricted Marketable Cost Gains Losses Fair Value Equivalents Cash Securities Cash $ 10,992 $ — $ — $ 10,992 $ 9,689 $ 1,303 $ — Level 1 (1): Money market funds 23,203 — — 23,203 23,203 — — U.S. treasury securities 18,938 — (4) 18,934 — — 18,934 Subtotal 42,141 — (4) 42,137 23,203 — 18,934 Level 2 (2): U.S. government agency securities 9,661 — (5) 9,656 — — 9,656 Total $ 62,794 $ — $ (9) $ 62,785 $ 32,892 $ 1,303 $ 28,590 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. (2) The fair value of Level 2 securities is estimated based on observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term on the assets or liabilities. |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment, net | |
Schedule of property and equipment | Property and equipment consisted of the following (in thousands): Estimated Useful December 31, Life in Years 2019 2018 Computers and software 3 - 5 $ 480 $ 752 Office equipment and furniture 5 706 832 Manufacturing equipment 5 10 242 Leasehold improvements 10 3,082 3,082 Leased assets 5 45 59 Total property and equipment 4,323 4,967 Less accumulated depreciation and amortization (1,618) (1,580) Property and equipment, net $ 2,705 $ 3,387 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2019 2018 Compensation and benefits $ 1,786 $ 1,524 Restructuring (severance) — 1,419 Pharmaceutical development expenses 445 231 Accrued interest 18 88 Other accrued expenses and other current liabilities 154 33 Total accrued expenses and other current liabilities $ 2,403 $ 3,295 |
Loans Payable (Tables)
Loans Payable (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Loans Payable | |
Schedule of debt | The following table summarizes how the issuance of Term Loans A, B, and C are reflected on the balance sheet at December 31, 2019 and 2018 (in thousands): December 31, December 31, 2019 2018 Gross proceeds $ 3,167 $ 15,833 Debt discount and debt issuance costs (1) 1,870 1,540 Carrying value 5,037 17,373 Current portion of loans payable, net 5,037 12,562 Loans payable, net $ — $ 4,811 (1) Includes the final fee payment due upon last payment date of the amounts borrowed. |
Schedule of maturities of long-term debt | Aggregate maturities of long-term debt as of December 31, 2019 are as follows (in thousands): 2020 (1) $ 3,167 2021 — 2022 — 2023 — 2024 — $ 3,167 Debt Discount and deferred financing costs (4) $ 3,163 (1) Excludes the final fee payment of $1.9 million due upon last payment date of the amounts borrowed. |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Schedule of share-based compensation expense recognized | The estimated grant‑date fair value of the Company’s share‑based awards is amortized on a straight-line basis over the awards’ service periods. Share‑based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2019 2018 2017 Research and development $ 825 $ 1,077 $ 1,954 General and administrative 2,407 3,290 4,433 Total stock-based compensation $ 3,232 $ 4,367 $ 6,387 |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2017 8,624,223 $ 5.22 7.17 Granted 4,065,375 1.70 Exercised (132,952) 0.63 Forfeited/Cancelled (4,291,439) (4.38) Balance, December 31, 2018 8,265,207 $ 3.99 6.99 Granted 1,033,000 1.10 Exercised (41,968) 0.68 Forfeited/Cancelled (1,687,935) (4.94) Balance, December 31, 2019 7,568,304 $ 3.40 7.01 Vested or expected to vest at December 31, 2019 7,568,304 $ 3.40 7.01 Exercisable at December 31, 2019 4,259,251 $ 4.24 5.92 |
Schedule of weighted-average assumptions: | Year Ended December 31, 2019 2018 2017 Expected term of options (in years) 6.1 5.8 6.2 Risk-free interest rate 1.9 % 2.8 % 2.0 % Expected volatility 98.9 % 71.7 % 75.6 % Dividend yield — % — % — % |
Schedule of changes in the status of non-vested RSU | Weighted Average Number of Grant Date Awards Fair Value Non-vested at December 31, 2017 — $ — Granted 1,255,000 0.65 Exercised — — Forfeited/Cancelled — — Non-vested at December 31, 2018 1,255,000 $ 0.65 Granted 2,500,585 0.74 Vested (572,500) 0.65 Forfeited (237,500) 0.65 Non-vested at December 31, 2019 2,945,585 $ 0.73 |
Schedule of shares available to be granted under equity incentive plans | At December 31, 2019, the Company has the following shares available to be granted: Inducement 2013 Plan Plan Available at December 31, 2018 2,603,983 144,125 Authorized 3,459,343 — Granted (3,533,585) — Forfeited/Cancelled 1,864,560 60,875 Available at December 31, 2019 4,394,301 205,000 |
Schedule of shares of common stock reserved/available | At December 31, 2019, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 7,273,304 Restricted stock units outstanding under 2013 Plan 2,945,585 Shares reserved for future issuance under 2013 Plan 4,394,301 Stock options outstanding under Inducement Plan 295,000 Shares reserved for future issuance under Inducement Plan 205,000 Shares reserved for future issuance under 2013 Employee Stock Purchase Plan 225,806 Warrants outstanding 623,091 Total shares of common stock reserved for future issuance 15,962,087 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies. | |
Schedule of balance sheet information related to leases | December 31, 2019 December 31, 2018 Operating leases: Operating lease right-of-use assets $ 5,472 $ — Other current liabilities 611 — Operating lease liabilities 7,793 — Total operating lease liabilities $ 8,404 $ — Finance leases: Property and equipment, at cost $ 45 $ 59 Accumulated depreciation (25) (29) Property and equipment, net 20 30 Other current liabilities 9 10 Other long-term liabilities 11 20 Total finance lease liabilities $ 20 $ 30 |
Schedule of components of lease expense | Year Ended December 31, 2019 2018 2017 Operating lease costs: Operating lease rental expense $ 1,187 $ 1,532 $ 1,355 Other income (1,263) (139) — Total operating lease costs $ (76) $ 1,393 $ 1,355 Finance lease costs: Amortization of right-of-use assets $ $ $ Interest on lease liabilities 2 3 2 Total finance lease costs $ 13 $ 15 $ 10 |
Schedule of cash flow information | Year Ended December 31, 2019 2018 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (167) $ (1,393) Operating cash flows from finance leases — — Financing cash flows from finance leases (12) (14) |
Schedule of maturities of operating lease liabilities | Operating Leases Financing Leases 2020 $ 1,352 $ 10 2021 1,376 8 2022 1,401 4 2023 1,425 — 2024 and beyond 6,586 — Total minimum lease payments $ 12,140 $ 22 Interest Expense (3,736) (2) Lease liability $ 8,404 $ 20 |
Schedule of maturities of financing lease liabilities | Operating Leases Financing Leases 2020 $ 1,352 $ 10 2021 1,376 8 2022 1,401 4 2023 1,425 — 2024 and beyond 6,586 — Total minimum lease payments $ 12,140 $ 22 Interest Expense (3,736) (2) Lease liability $ 8,404 $ 20 |
Schedule of expected sublease inflows | Sublease 2020 $ 1,078 2021 943 2022 — 2023 — 2024 and beyond — Total minimum lease payments $ 2,021 |
Schedule of lease term and discount rates | Year Ended December 31, 2019 2018 Weighted average remaining lease term (years) Operating leases 8 9 Finance leases 2 2 Weighted average discount rate Operating leases Finance leases |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring Charges | |
Schedule of restructuring balances | The following table summarizes the restructuring balances at December 31, 2019 and 2018 (in thousands): Year Ended December 31, 2019 2018 Balance, January 1 $ 1,419 $ 1,077 Current year restructuring costs — 1,427 Payment of employee severance costs (1,419) (1,085) Balance, December 31 $ — $ 1,419 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Net Loss Per Common Share | |
Schedule of computation of basic and diluted net loss per share | The following table sets forth the computation of basic and diluted net loss per share for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2019 2018 2017 Basic and diluted net loss per common share calculation: Net loss $ (24,871) $ (30,784) $ (71,865) Net loss attributable to common stockholders $ (24,871) $ (30,784) $ (71,865) Weighted average common shares outstanding 91,677,963 73,558,548 59,436,649 Net loss per share of common stock - basic and diluted $ (0.27) $ (0.42) $ (1.21) |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | December 31, 2019 2018 2017 Options outstanding 7,568,304 8,265,207 8,624,223 RSUs outstanding 2,945,585 1,255,000 — Warrants 623,091 123,091 123,091 Total 11,136,980 9,643,298 8,747,314 |
Comprehensive Income (Loss) (Ta
Comprehensive Income (Loss) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Comprehensive Income (Loss) | |
Schedule of components of accumulated other comprehensive income or loss, net of tax | The following table presents changes in the components of accumulated other comprehensive income or loss, net of tax (in thousands): Balance, January 1, 2018 $ (42) Net unrealized loss arising during the period 33 Balance, December 31, 2018 $ (9) Net unrealized gain on marketable securities 9 Balance, December 31, 2019 $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Summary of income tax provision | The income tax provision for the years ended December 31, 2019 and 2018 are as follows (in thousands): December 31, 2019 2018 Current: Federal $ — $ 745 State — — Total — 745 Deferred Federal — — State — — Total — — Total income tax provision (benefit) $ — $ 745 |
Schedule of significant components of the Company's deferred tax assets | Significant components of the Company’s net deferred tax assets as of December 31, 2019 and 2018 are as follows (in thousands): December 31, 2019 2018 Deferred tax assets: NOLs $ 22,033 $ 18,942 Research and development credits 14,138 13,086 Research and development expenses capitalized for tax purposes 92,350 88,485 Deferred rent 847 321 Depreciation 162 19 Other temporary differences 5,124 4,823 Total deferred tax assets 134,654 125,676 Deferred tax liabilities: Prepaid expenses (86) (64) Total deferred tax liabilities (86) (64) Net deferred tax assets 134,568 125,612 Less valuation allowance (134,568) (125,612) Net deferred tax asset $ — $ — |
Schedule of reconciliation of income tax expense computed at the statutory federal income tax rate to income taxes as reflected in the financial statements | December 31, 2019 2018 2017 Percent of pre-tax income: U.S. federal statutory income tax rate 21.0 % 21.0 % 34.0 % Permanent Differences — % (0.1) % 0.1 % State taxes, net of federal benefit 8.3 % 7.9 % 6.7 % Research and development credit 3.4 % 2.8 % 1.7 % Rate change due to the Tax Act — % — % (58.5) % Withholding Tax — % (2.4) % — % Other 3.3 % — % 1.0 % Change in valuation allowance (36.0) % (31.6) % 15.0 % Effective income tax rate — % (2.4) % — % |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Quarterly Financial Data (Unaudited) | |
Condensed Income Statement | First Quarter Second Quarter Third Quarter Fourth Quarter (in thousands, except share and per share amounts) 2019 Total revenue $ — $ — $ — $ 31 Loss from operations $ (5,214) $ (6,141) $ (8,755) $ (6,470) Net loss $ (5,169) $ (4,691) $ (8,566) $ (6,445) Net loss per share of common, basic and diluted $ (0.06) $ (0.05) $ (0.09) $ (0.07) Weighted average shares outstanding, basic and diluted 88,897,292 92,414,644 92,569,993 92,777,480 2018 Total revenue $ — $ 2,500 $ 3,000 $ 232 Loss from operations $ (9,693) $ (8,595) $ (4,258) $ (7,951) Net loss $ (9,021) $ (9,304) $ (4,483) $ (7,976) Net loss per share of common, basic and diluted $ (0.14) $ (0.13) $ (0.06) $ (0.10) Weighted average shares outstanding, basic and diluted 64,562,236 69,664,994 77,445,675 82,323,393 |
Organization and Description _2
Organization and Description of the Business (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($)segment | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Organization and Description of the Business | |||||||||||
Number of operating segments | segment | 1 | ||||||||||
Accumulated deficit | $ 413,145 | $ 388,274 | $ 413,145 | $ 388,274 | |||||||
Net loss | 6,445 | $ 8,566 | $ 4,691 | $ 5,169 | 7,976 | $ 4,483 | $ 9,304 | $ 9,021 | 24,871 | 30,784 | $ 71,865 |
Cash and cash equivalents | 32,305 | 32,892 | 32,305 | 32,892 | |||||||
Marketable securities | $ 3,500 | $ 28,590 | $ 3,500 | $ 28,590 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ / shares in Units, $ in Thousands | Jan. 01, 2019USD ($) | Dec. 31, 2019USD ($)segmentitem$ / shares | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017$ / shares | Dec. 31, 2018USD ($) |
Investments | |||||
Marketable securities | $ 3,500 | $ 28,590 | $ 28,590 | ||
Restricted Cash | |||||
Letters of credit | 1,300 | ||||
Impairment of property and equipment | $ 108 | $ 0 | |||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||||
Number of operating segments | segment | 1 | ||||
Stock-Based Compensation | |||||
Number of stock-based compensation plans | item | 2 | ||||
Dividend yield | 0.00% | 0.00% | 0.00% | ||
Basic and diluted net loss per common share calculation: | |||||
Difference between basic and diluted net loss per share of Common Stock (in dollars per share) | $ / shares | $ 0 | $ 0 | $ 0 | ||
Recent Accounting Standards | |||||
Lease, Practical Expedients, Package [true false] | true | ||||
Lease, Practical Expedient, Use of Hindsight [true false] | false | ||||
ASU 2016-02 | |||||
Recent Accounting Standards | |||||
Right of use assets | $ 5,700 | ||||
Lease liabilities | $ 8,800 | ||||
Computer equipment | |||||
Restricted Cash | |||||
Estimated useful life | P3Y | ||||
Laboratory equipment, office equipment, furniture and software | |||||
Restricted Cash | |||||
Estimated useful life | P5Y |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Hierarchy Table (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair value | ||
Unrealized Losses | $ (9) | |
Transfers between Level 2 and Level 3 | $ 0 | 0 |
Letter of credit collateral | 1,300 | |
Adjusted cost | ||
Fair value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 9,302 | 10,992 |
Assets, Fair Value Disclosure | 37,114 | 62,794 |
Fair Value | ||
Fair value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 9,302 | 10,992 |
Assets, Fair Value Disclosure | 37,114 | 62,785 |
Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 7,993 | 9,689 |
Assets, Fair Value Disclosure | 32,305 | 32,892 |
Restricted Cash | Fair Value | ||
Fair value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 1,309 | 1,303 |
Assets, Fair Value Disclosure | 1,309 | 1,303 |
Marketable Securities | Fair Value | ||
Fair value | ||
Assets, Fair Value Disclosure | 3,500 | 28,590 |
Level 1 | ||
Fair value | ||
Unrealized Losses | (4) | |
Level 1 | Adjusted cost | ||
Fair value | ||
Investments, Fair Value Disclosure | 24,302 | 42,141 |
Level 1 | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 24,302 | 42,137 |
Level 1 | Money market funds | Adjusted cost | ||
Fair value | ||
Investments, Fair Value Disclosure | 18,306 | 23,203 |
Level 1 | Money market funds | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 18,306 | 23,203 |
Level 1 | U.S. treasury securities | ||
Fair value | ||
Unrealized Losses | (4) | |
Level 1 | U.S. treasury securities | Adjusted cost | ||
Fair value | ||
Investments, Fair Value Disclosure | 5,996 | 18,938 |
Level 1 | U.S. treasury securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 5,996 | 18,934 |
Level 1 | Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 20,802 | 23,203 |
Level 1 | Cash and Cash Equivalents | Money market funds | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 18,306 | 23,203 |
Level 1 | Cash and Cash Equivalents | U.S. treasury securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 2,496 | |
Level 1 | Marketable Securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 3,500 | 18,934 |
Level 1 | Marketable Securities | U.S. treasury securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 3,500 | 18,934 |
Level 2 | U.S. government agency securities | ||
Fair value | ||
Unrealized Losses | (5) | |
Level 2 | U.S. government agency securities | Adjusted cost | ||
Fair value | ||
Investments, Fair Value Disclosure | 3,510 | 9,661 |
Level 2 | U.S. government agency securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 3,510 | 9,656 |
Level 2 | Cash and Cash Equivalents | U.S. government agency securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | $ 3,510 | |
Level 2 | Marketable Securities | U.S. government agency securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | $ 9,656 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property and Equipment | |||
Total property and equipment | $ 4,323 | $ 4,967 | |
Accumulated depreciation | (1,618) | (1,580) | |
Property and equipment, net | 2,705 | 3,387 | |
Depreciation and amortization expense | 562 | 645 | $ 490 |
Computers and software | |||
Property and Equipment | |||
Total property and equipment | $ 480 | 752 | |
Computers and software | Minimum | |||
Property and Equipment | |||
Estimated useful life | P3Y | ||
Computers and software | Maximum | |||
Property and Equipment | |||
Estimated useful life | P5Y | ||
Office equipment and furniture | |||
Property and Equipment | |||
Estimated useful life | P5Y | ||
Total property and equipment | $ 706 | 832 | |
Manufacturing equipment | |||
Property and Equipment | |||
Estimated useful life | P5Y | ||
Total property and equipment | $ 10 | 242 | |
Leasehold improvements | |||
Property and Equipment | |||
Estimated useful life | P10Y | ||
Total property and equipment | $ 3,082 | 3,082 | |
Leased Assets | |||
Property and Equipment | |||
Estimated useful life | P5Y | ||
Total property and equipment | $ 45 | $ 59 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Accrued Expenses and Other Current Liabilities | |||
Compensation and benefits | $ 1,786 | $ 1,524 | |
Restructuring (severance) | 0 | 1,419 | $ 1,077 |
Pharmaceutical development expenses | 445 | 231 | |
Accrued interest | 18 | 88 | |
Other accrued expenses and other current liabilities | 154 | 33 | |
Total accrued expenses and other current liabilities | $ 2,403 | $ 3,295 |
Loans Payable (Details)
Loans Payable (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Dec. 31, 2015USD ($)item$ / sharesshares | Sep. 30, 2014USD ($)tranche$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Long Term Debt | |||||||
Gross proceeds | $ 3,167 | ||||||
Aggregate principal balance outstanding | 3,163 | ||||||
Interest expense | 931 | $ 2,231 | $ 2,780 | ||||
Debt discount and debt issuance costs | 4 | ||||||
Amortization of debt discount and issuance costs | 100 | 200 | 300 | ||||
Loan and security agreement | |||||||
Long Term Debt | |||||||
Face amount | $ 35,000 | ||||||
Debt number of tranches | tranche | 3 | ||||||
Gross proceeds | $ 3,167 | 15,833 | |||||
Final payment fee percentage | 6.60% | ||||||
Interest expense | $ 600 | $ 1,400 | $ 1,700 | ||||
Debt discount and debt issuance costs | $ 1,000 | ||||||
Term Loan A | |||||||
Long Term Debt | |||||||
Face amount | $ 2,000 | ||||||
Interest rate (as a percent) | 6.50% | ||||||
Term Loan A | Common Stock | Warrants | |||||||
Long Term Debt | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 7,678 | 5,728 | |||||
Exercise price | $ / shares | $ 5.8610 | ||||||
Term Loan B | |||||||
Long Term Debt | |||||||
Face amount | $ 16,500 | ||||||
Interest rate (as a percent) | 6.50% | ||||||
Term Loan B | Common Stock | Warrants | |||||||
Long Term Debt | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 34,961 | ||||||
Exercise price | $ / shares | $ 10.6190 | ||||||
Term Loan C | |||||||
Long Term Debt | |||||||
Face amount | $ 10,000 | ||||||
Debt Instrument Borrowing Capacity | $ 16,500 | ||||||
Remaining amount available | $ 10,000 | ||||||
Number of specified triggers needed to be satisfied to draw on loan | item | 1 | ||||||
Interest rate (as a percent) | 6.98% | ||||||
Prepayment fee percent | 1.00% | ||||||
Term Loan C | Common Stock | Warrants | |||||||
Long Term Debt | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 62,241 | ||||||
Exercise price | $ / shares | $ 3.6150 | ||||||
Term Loans A, B, and C | |||||||
Long Term Debt | |||||||
Aggregate principal balance outstanding | $ 3,200 |
Loans Payable Schedule of Debt
Loans Payable Schedule of Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Long Term Debt | ||
Gross proceeds | $ 3,167 | |
Current portion of loans payable, net | 5,037 | $ 12,562 |
Loans payable, net | 4,811 | |
Loan and security agreement | ||
Long Term Debt | ||
Gross proceeds | 3,167 | 15,833 |
Debt discount and debt issuance costs | 1,870 | 1,540 |
Carrying value | 5,037 | 17,373 |
Current portion of loans payable, net | $ 5,037 | 12,562 |
Loans payable, net | $ 4,811 |
Loans Payable - Maturities (Det
Loans Payable - Maturities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Aggregate maturities of long term debt | |
2020 | $ 3,167 |
2021 | 0 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
Loans payable, gross | 3,167 |
Debt Discount and deferred financing costs | (4) |
Total, net | 3,163 |
Final fee payment | $ 1,900 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings (Details) | Jan. 29, 2019USD ($)Institution$ / sharesshares | Jan. 28, 2019USD ($)$ / sharesshares | Dec. 14, 2015USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($) |
Stockholders' Equity | |||||||
Common stock authorized (in shares) | shares | 200,000,000 | 200,000,000 | |||||
Preferred stock authorized (in shares) | shares | 5,000,000 | 5,000,000 | |||||
Net proceeds from the offering | $ 10,312,000 | $ 33,195,000 | $ 20,712,000 | ||||
Offering price (in dollars per share) | $ / shares | $ 1 | ||||||
Issuance of common stock, net of issuance costs | 9,965,000 | $ 33,194,000 | $ 20,712,000 | ||||
Wainwright | |||||||
Stockholders' Equity | |||||||
Percentage of aggregate gross proceeds paid | 7.00% | ||||||
Expenses paid | $ 50,000 | ||||||
Warrants to purchase shares of common stock | shares | 500,000 | ||||||
Warrants term | 5 years | ||||||
Exercise price (in dollars per share) | $ / shares | $ 1.25 | ||||||
At-the-market sales facility - December 14, 2015 agreement | |||||||
Stockholders' Equity | |||||||
Offering amount | 0 | ||||||
Issuance of common stock (in shares) | shares | 11,400,000 | ||||||
Issuance of common stock, net of issuance costs | $ 20,000,000 | ||||||
At-the-market sales facility - December 14, 2015 agreement | Maximum | |||||||
Stockholders' Equity | |||||||
Offering amount | $ 75,000,000 | ||||||
Commission (as a percent) | 3.00% | ||||||
At-the-market sales facility - June 2018 agreement | |||||||
Stockholders' Equity | |||||||
Offering amount | $ 50,000,000 | 0 | |||||
Shelf registration | $ 175,000,000 | ||||||
Issuance of common stock (in shares) | shares | 8,500,000 | ||||||
Issuance of common stock, net of issuance costs | $ 13,200,000 | ||||||
At-the-market sales facility - April 17, 2019 agreement | Maximum | |||||||
Stockholders' Equity | |||||||
Offering amount | $ 50,000,000 | ||||||
Private Placement | |||||||
Stockholders' Equity | |||||||
Issuance of common stock (in shares) | shares | 10,000,000 | ||||||
Issuance of common stock, net of issuance costs | $ 9,200,000 | ||||||
Number of institutional investors | Institution | 2 | ||||||
CW ATM Program | |||||||
Stockholders' Equity | |||||||
Issuance of common stock (in shares) | shares | 1,400,000 | ||||||
Net proceeds from the offering | $ 1,100,000 | ||||||
Stock available for further issuance | $ 48,900,000 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plans (Details) - USD ($) $ in Thousands | Dec. 15, 2016 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Equity Incentive Plans | ||||
Stock-based compensation | $ 3,232 | $ 4,367 | $ 6,387 | |
Research and Development Expense | ||||
Equity Incentive Plans | ||||
Stock-based compensation | 825 | 1,077 | 1,954 | |
General and Administrative Expense | ||||
Equity Incentive Plans | ||||
Stock-based compensation | $ 2,407 | $ 3,290 | $ 4,433 | |
2008 Plan and 2013 Plan | ||||
Equity Incentive Plans | ||||
Authorized (in shares) | 500,000 | |||
2008 Plan and 2013 Plan | Maximum | ||||
Equity Incentive Plans | ||||
Term of award | 10 years | |||
Vesting period | 4 years |
Stockholders' Equity - Options
Stockholders' Equity - Options Outstanding (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 28, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Weighted Average Remaining Contractual Term | ||||
Allocated share-based compensation expense | $ 3,232 | $ 4,367 | $ 6,387 | |
Employee stock options | ||||
Number of Shares | ||||
Granted (in shares) | 1,803,625 | |||
Weighted Average Remaining Contractual Term | ||||
Vesting period | 4 years | |||
Allocated share-based compensation expense | $ 0 | |||
Unrecognized compensation expense | $ 100 | $ 100 | ||
Employee stock options | Vesting period One | ||||
Weighted Average Remaining Contractual Term | ||||
Vesting percentage | 50.00% | |||
Employee stock options | Vesting period Two | ||||
Weighted Average Remaining Contractual Term | ||||
Vesting percentage | 50.00% | |||
Employee Stock Option | ||||
Number of Shares | ||||
Balance at the beginning of the period (in shares) | 8,265,207 | 8,624,223 | ||
Granted (in shares) | 1,033,000 | 4,065,375 | ||
Exercised (in shares) | (41,968) | (132,952) | ||
Forfeited/Cancelled (in shares) | (1,687,935) | (4,291,439) | ||
Balance at the end of the period (in shares) | 7,568,304 | 8,265,207 | 8,624,223 | |
Vested or expected to vest at the end of the period (in shares) | 7,568,304 | |||
Exercisable at the end of the period (in shares) | 4,259,251 | |||
Weighted-Average Exercise Price | ||||
Balance at the beginning of the period (in dollars per share) | $ 3.99 | $ 5.22 | ||
Granted (in dollars per share) | 1.10 | 1.70 | ||
Exercised (in dollars per share) | 0.68 | 0.63 | ||
Forfeited/Cancelled (in dollars per share) | (4.94) | (4.38) | ||
Balance at the end of the period (in dollars per share) | 3.40 | $ 3.99 | $ 5.22 | |
Vested or expected to vest at the end of the period (in dollars per share) | 3.40 | |||
Exercisable at the end of the period (in dollars per share) | $ 4.24 | |||
Weighted Average Remaining Contractual Term | ||||
Options Outstanding at the end of the period | 7 years 4 days | 6 years 11 months 27 days | 7 years 2 months 1 day | |
Vested or expected to vest at the end of the period | 7 years 4 days | |||
Exercisable at the end of the period | 5 years 11 months 1 day | |||
Intrinsic value of options exercisable | $ 100 | |||
Offering price | $ 0.84 | |||
Per-share weighted-average grant date fair value of options granted (in dollars per share) | $ 0.86 | $ 1.13 | $ 2.68 | |
Unrecognized compensation expense | $ 2,900 |
Stockholders' Equity - Assumpti
Stockholders' Equity - Assumptions Used (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stockholders' Equity | |||
Expected term of options (in years) | 6 years 1 month 6 days | 5 years 9 months 18 days | 6 years 2 months 12 days |
Risk-free interest rate (as a percent) | 1.90% | 2.80% | 2.00% |
Expected volatility (as a percent) | 98.90% | 71.70% | 75.60% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Employee Stock Option | |||
Stockholders' Equity | |||
Unrecognized compensation expense | $ 2.9 | ||
Weighted average remaining period for recognition of unrecognized compensation expense | 1 year 11 months 9 days |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock Units (Details) - $ / shares | Dec. 05, 2019 | Dec. 06, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Stockholders' Equity | ||||
Shares underlying exercised | 166,407 | |||
Restricted Stock Units | ||||
Stockholders' Equity | ||||
Number of shares granted | 2,170,585 | 1,255,000 | 2,500,585 | 1,255,000 |
Restricted Stock Units | Vesting period One | ||||
Stockholders' Equity | ||||
Vesting percentage | 50.00% | 25.00% | ||
Offering price | $ 0.72 | $ 0.64 | ||
Restricted Stock Units | Vesting period Two | ||||
Stockholders' Equity | ||||
Vesting percentage | 50.00% | 25.00% | ||
Offering price | $ 0.72 | $ 0.65 |
Stockholders' Equity - Non-vest
Stockholders' Equity - Non-vested RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 05, 2019 | Dec. 06, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Weighted Average Grant Date Fair Value | |||||
Stock-based compensation | $ 3,232 | $ 4,367 | $ 6,387 | ||
Restricted Stock Units | |||||
Number of Shares | |||||
Non-vested at beginning of period (in shares) | 1,255,000 | ||||
Granted (in shares) | 2,170,585 | 1,255,000 | 2,500,585 | 1,255,000 | |
Vested (in shares) | (572,500) | ||||
Forfeited/Cancelled | (237,500) | ||||
Non-vested at end of period (in shares) | 2,945,585 | 1,255,000 | |||
Weighted Average Grant Date Fair Value | |||||
Non-vested at beginning of period (in dollars per share) | $ 0.65 | ||||
Granted (in dollars per share) | 0.74 | $ 0.65 | |||
Vested (in dollars per share) | 0.65 | ||||
Forfeited (in dollars per share) | 0.65 | ||||
Non-vested at end of period (in dollars per share) | $ 0.73 | $ 0.65 | |||
Unrecognized compensation expense | $ 2,000 | ||||
Weighted average remaining period for recognition of unrecognized compensation expense | 1 year 11 months 16 days | ||||
Maximum | Restricted Stock Units | |||||
Weighted Average Grant Date Fair Value | |||||
Stock-based compensation | $ 500 | $ 100 |
Stockholders' Equity - Availabl
Stockholders' Equity - Available for Grant (Details) | 12 Months Ended |
Dec. 31, 2019shares | |
2013 plan | |
Stockholders' Equity | |
Balance at the beginning of the period (in shares) | 2,603,983 |
Authorized (in shares) | 3,459,343 |
Granted (in shares) | (3,533,585) |
Forfeitures/Expirations (in shares) | 1,864,560 |
Balance at the end of the period (in shares) | 4,394,301 |
Inducement Plan | |
Stockholders' Equity | |
Balance at the beginning of the period (in shares) | 144,125 |
Authorized (in shares) | 0 |
Granted (in shares) | 0 |
Forfeitures/Expirations (in shares) | 60,875 |
Balance at the end of the period (in shares) | 205,000 |
Stockholders' Equity - Shares A
Stockholders' Equity - Shares Available for Future Issuance (Details) - shares | Dec. 31, 2019 | Dec. 31, 2018 |
Stockholders' Equity | ||
Employee stock purchase plan (in shares) | 225,806 | |
Warrants outstanding (in shares) | 623,091 | |
Total shares of common stock reserved for future issuance (in shares) | 15,962,087 | |
2013 plan | ||
Stockholders' Equity | ||
Stock options outstanding (in shares) | 7,273,304 | |
Shares available for future grant (in shares) | 4,394,301 | 2,603,983 |
2013 plan | Restricted Stock Units | ||
Stockholders' Equity | ||
Stock options outstanding (in shares) | 2,945,585 | |
Inducement Plan | ||
Stockholders' Equity | ||
Stock options outstanding (in shares) | 295,000 | |
Shares available for future grant (in shares) | 205,000 | 144,125 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) $ in Thousands | Oct. 11, 2018ft²$ / ft² | Nov. 30, 2017USD ($)ft² | Oct. 31, 2017USD ($) | Dec. 31, 2019USD ($)ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Lessee, Lease, Description [Line Items] | ||||||
Deferred rent | $ | $ 0 | $ 3,100 | $ 3,100 | |||
Chesterbrook, Pennsylvania | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Number of square feet of space leased on the first floor | 8,231 | |||||
Number of square feet of space leased on the second floor | 40,565 | |||||
Chesterbrook, Pennsylvania | Sublease Agreements | Vanguard Group, Inc | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Number of square feet of space being subleased on second floor | 40,565 | |||||
Initial term of sublease | 37 months | |||||
Term of optional sublease extension | 3 years | |||||
Amount per square foot less for rent during months 2 to 13 | $ / ft² | 0.50 | |||||
Amount per square foot for rent after month 14 | $ / ft² | 1 | |||||
King of Prussia, Pennsylvania | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Termination fees for cancellation of lease | $ | $ 150 | |||||
Area of office and laboratory space where lease terminated | 16,714 | |||||
Exton, Pennsylvania | Maximum | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Termination fees for cancellation of lease | $ | $ 100 |
Commitments and Contingencies_2
Commitments and Contingencies - Balance sheet information related to leases (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ 5,472 | |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OperatingLeaseRightOfUseAsset | |
Operating lease liabilities - Current | $ 611 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Operating lease liabilities - Noncurrent | $ 7,793 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OperatingLeaseLiabilityNoncurrent | |
Lease Liability | $ 8,404 | |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent us-gaap:OperatingLeaseLiabilityNoncurrent | |
Property and equipment, at cost | $ 4,323 | $ 4,967 |
Accumulated depreciation | (1,618) | (1,580) |
Property and equipment, net | 2,705 | 3,387 |
Finance lease liabilities - Current | $ 9 | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Finance lease liabilities - Noncurrent | $ 11 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | |
Lease Liability | $ 20 | |
Finance Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent us-gaap:OtherLiabilitiesNoncurrent | |
Capital Lease Obligations, Total | 30 | |
Other current liabilities | ||
Lessee, Lease, Description [Line Items] | ||
Capital lease obligation - Current | 10 | |
Other long-term liabilities | ||
Lessee, Lease, Description [Line Items] | ||
Capital lease obligation - Noncurrent | 20 | |
Finance leased assets | ||
Lessee, Lease, Description [Line Items] | ||
Property and equipment, at cost | $ 45 | |
Accumulated depreciation | (25) | |
Property and equipment, net | $ 20 | |
Capital leased assets | ||
Lessee, Lease, Description [Line Items] | ||
Property and equipment, at cost | 59 | |
Accumulated depreciation | (29) | |
Property and equipment, net | $ 30 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating lease costs: | |||
Operating lease rental expense | $ 1,187 | ||
Sublease income | (1,263) | ||
Total operating lease costs | (76) | ||
Finance lease costs: | |||
Amortization of right-of-use assets | 11 | ||
Interest on lease liabilities | 2 | ||
Total finance lease costs | $ 13 | ||
Operating lease costs: | |||
Operating lease rental expense | $ 1,532 | $ 1,355 | |
Sublease income | (139) | ||
Total operating lease costs | 1,393 | 1,355 | |
Finance lease costs: | |||
Amortization of right-of-use assets | 12 | 8 | |
Interest on lease liabilities | 3 | 2 | |
Total finance lease costs | $ 15 | $ 10 |
Commitments and Contingencies_4
Commitments and Contingencies - Cash flow information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ (167) | |
Operating cash flows from operating leases, pre-adoption | $ (1,393) | |
Financing cash flows from finance leases | $ (12) | |
Financing cash flows from finance leases, pre-adoption | $ (14) |
Commitments and Contingencies_5
Commitments and Contingencies - Lease liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Operating Leases | |
2020 | $ 1,352 |
2021 | 1,376 |
2022 | 1,401 |
2023 | 1,425 |
2024 and beyond | 6,586 |
Total minimum lease payments | 12,140 |
Interest Expense | (3,736) |
Lease Liability | 8,404 |
Financing Leases | |
2020 | 10 |
2021 | 8 |
2022 | 4 |
Total minimum lease payments | 22 |
Interest Expense | (2) |
Lease Liability | 20 |
Sublease | |
2020 | 1,078 |
2021 | 943 |
Total minimum lease payments | $ 2,021 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease term and discount rates (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2019 | |
Commitments and Contingencies. | ||
Weighted average remaining lease term - Operating leases | 8 years | |
Weighted average remaining lease term - Finance leases | 2 years | |
Weighted average discount rate - Operating leases | 9.20% | |
Weighted average discount rate - Finance leases | 6.50% | |
Weighted average remaining lease term - Operating leases | 9 years | |
Weighted average remaining lease term - Finance leases | 2 years | |
Weighted average discount rate - Operating leases | 0.00% | |
Weighted average discount rate - Finance leases | 6.50% |
Commitments and Contingencies_7
Commitments and Contingencies - Legal Proceedings (Details) - item | Aug. 02, 2019 | May 29, 2019 | Feb. 28, 2019 | Jan. 31, 2019 | Nov. 30, 2018 |
Class Actions In Eastern District Of Pennsylvania [Member] | |||||
Loss Contingencies [Line Items] | |||||
Number of claims | 3 | 3 | |||
Number of claims after consolidation | 1 | ||||
Number of investors appointed | 5 | ||||
Number of former officers | 2 | ||||
Shareholder Derivative Actions [Member] | |||||
Loss Contingencies [Line Items] | |||||
Number of claims | 2 |
Licensing Arrangements (Details
Licensing Arrangements (Details) $ in Millions | 1 Months Ended |
Apr. 30, 2018USD ($) | |
Pharmbio Korea Inc | |
Licensing Arrangements | |
Upfront payment | $ 3 |
Withholding taxes | $ 0.5 |
Time period for written notice to terminate license agreement | 180 days |
Pharmbio Korea Inc | Minimum | |
Licensing Arrangements | |
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months |
Pharmbio Korea Inc | Maximum | |
Licensing Arrangements | |
Commercialization milestone payments | $ 0.5 |
Royalties on product sales, percentage | 20.00% |
Jiangsu Nhwa Pharmaceutical Co Ltd | |
Licensing Arrangements | |
Upfront payment | $ 2.5 |
Withholding taxes | $ 0.3 |
Royalties on product sales, percentage | 10.00% |
Time period for written notice to terminate license agreement | 180 days |
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months |
Milestone payment | $ 3 |
Jiangsu Nhwa Pharmaceutical Co Ltd | Maximum | |
Licensing Arrangements | |
Commercialization milestone payments | $ 6 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Apr. 30, 2018 | 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 | |
Revenue | ||||||||||||
Revenues | $ 31 | $ 0 | $ 0 | $ 0 | $ 232 | $ 3,000 | $ 2,500 | $ 0 | $ 31 | $ 5,732 | $ 0 | |
Revenue, Product and Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | |
Pharmbio Korea Inc | ||||||||||||
Revenue | ||||||||||||
License revenues | $ 3,000 | |||||||||||
Revenues | $ 3,000 | |||||||||||
Revenue, Product and Service [Extensible List] | us-gaap:LicenseMember | |||||||||||
Jiangsu Nhwa Pharmaceutical Co Ltd | ||||||||||||
Revenue | ||||||||||||
License revenues | $ 2,500 | |||||||||||
Revenues | $ 2,700 | |||||||||||
Revenue, Product and Service [Extensible List] | us-gaap:LicenseMember |
Restructuring Charges (Details)
Restructuring Charges (Details) $ in Thousands | Nov. 08, 2018employee | Dec. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Summary of restructuring balances | |||||
Beginning balance | $ 1,419 | $ 1,077 | |||
Current year restructuring costs | 1,427 | $ 1,774 | |||
Payment of employee severance costs | (1,419) | (1,085) | |||
Ending balance | $ 1,419 | $ 0 | $ 1,419 | $ 1,077 | |
Employee Severance | |||||
Restructuring Charges | |||||
Number of positions eliminated, percent | 33.33% | ||||
Number of positions eliminated | employee | 14 | ||||
Total costs related to the restructuring | $ 1,400 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (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 | |
Basic and diluted net loss per common share calculation: | |||||||||||
Net loss | $ (6,445) | $ (8,566) | $ (4,691) | $ (5,169) | $ (7,976) | $ (4,483) | $ (9,304) | $ (9,021) | $ (24,871) | $ (30,784) | $ (71,865) |
Net loss attributable to common stockholders | $ (24,871) | $ (30,784) | $ (71,865) | ||||||||
Weighted average common shares outstanding (in shares) | 92,777,480 | 92,569,993 | 92,414,644 | 88,897,292 | 82,323,393 | 77,445,675 | 69,664,994 | 64,562,236 | 91,677,963 | 73,558,548 | 59,436,649 |
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.07) | $ (0.09) | $ (0.05) | $ (0.06) | $ (0.10) | $ (0.06) | $ (0.13) | $ (0.14) | $ (0.27) | $ (0.42) | $ (1.21) |
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 11,136,980 | 9,643,298 | 8,747,314 | ||||||||
Employee Stock Option | |||||||||||
Basic and diluted net loss per common share calculation: | |||||||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 7,568,304 | 8,265,207 | 8,624,223 | ||||||||
Restricted Stock Units | |||||||||||
Basic and diluted net loss per common share calculation: | |||||||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 2,945,585 | 1,255,000 | |||||||||
Warrants | |||||||||||
Basic and diluted net loss per common share calculation: | |||||||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 623,091 | 123,091 | 123,091 |
Comprehensive Income (Loss) (De
Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Other Comprehensive Loss | ||
Beginning Balance | $ 41,526 | $ 34,633 |
Ending Balance | 30,078 | 41,526 |
Reclassifications out of accumulated other comprehensive income or loss, net of tax | 0 | 0 |
Tax effect | 0 | 0 |
Accumulated Other Comprehensive Income (Loss) | ||
Other Comprehensive Loss | ||
Beginning Balance | (9) | (42) |
Net unrealized gains (loss) on marketable securities | $ 9 | 33 |
Ending Balance | $ (9) |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | Jan. 01, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Income Taxes | ||||
Withholding tax | $ 0 | $ 0.8 | ||
Increase in valuation allowance | $ 9 | |||
U.S. federal statutory income tax rate | 21.00% | 21.00% | 21.00% | 34.00% |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Current: | |
Federal | $ 745 |
Total | 745 |
Total income tax provision (benefit) | $ 745 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
NOLs | $ 22,033 | $ 18,942 |
Research and development credits | 14,138 | 13,086 |
Research and development expenses capitalized for tax purposes | 92,350 | 88,485 |
Deferred rent | 847 | 321 |
Depreciation | 162 | 19 |
Other temporary differences | 5,124 | 4,823 |
Total deferred tax assets | 134,654 | 125,676 |
Deferred tax liabilities: | ||
Prepaid expenses | (86) | (64) |
Total deferred tax liabilities | (86) | (64) |
Net deferred tax assets | 134,568 | 125,612 |
Less valuation allowance | (134,568) | (125,612) |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Effective Tax Ra
Income Taxes - Effective Tax Rate Reconciliation (Details) - USD ($) $ in Millions | Jan. 01, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Percent of pre-tax income: | ||||
U.S. federal statutory income tax rate | 21.00% | 21.00% | 21.00% | 34.00% |
Permanent Differences | 0.00% | (0.10%) | 0.10% | |
State taxes, net of federal benefit | 8.30% | 7.90% | 6.70% | |
Research and development credit | 3.40% | 2.80% | 1.70% | |
Rate change due to the Tax Act | 0.00% | 0.00% | (58.50%) | |
Withholding Tax | 0.00% | (2.40%) | 0.00% | |
Other | 3.30% | 0.00% | 1.00% | |
Change in valuation allowance | (36.00%) | (31.60%) | 15.00% | |
Effective income tax rate | 0.00% | (2.40%) | 0.00% | |
U.S. federal | ||||
Operating loss carryforwards | ||||
Net operating loss carryforwards | $ 76.7 | |||
State Jurisdiction | ||||
Operating loss carryforwards | ||||
Tax credit carryforwards | 75.2 | |||
Research Tax Credit Carryforward | U.S. federal | ||||
Operating loss carryforwards | ||||
Tax credit carryforwards | $ 14.1 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Benefit Plan | |||
Employer matching contribution for employee's contributions of the first 3% of eligible compensation | 100.00% | ||
Percentage of eligible compensation, matched 100% by employer | 3.00% | ||
Employer matching contribution for employee's contributions of the next 2% of eligible compensation | 50.00% | ||
Percentage of eligible compensation, matched 50% by employer | 2.00% | ||
Company's matching contributions to the plan | $ 0.2 | $ 0.4 | $ 0.4 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Selected Quarterly Financial Data (Unaudited) | |||||||||||
Total revenue | $ 31 | $ 0 | $ 0 | $ 0 | $ 232 | $ 3,000 | $ 2,500 | $ 0 | $ 31 | $ 5,732 | $ 0 |
Revenue, Product and Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Loss from operations | $ (6,470) | $ (8,755) | $ (6,141) | $ (5,214) | $ (7,951) | $ (4,258) | $ (8,595) | $ (9,693) | $ (26,580) | $ (30,498) | $ (70,387) |
Net loss | $ (6,445) | $ (8,566) | $ (4,691) | $ (5,169) | $ (7,976) | $ (4,483) | $ (9,304) | $ (9,021) | $ (24,871) | $ (30,784) | $ (71,865) |
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.07) | $ (0.09) | $ (0.05) | $ (0.06) | $ (0.10) | $ (0.06) | $ (0.13) | $ (0.14) | $ (0.27) | $ (0.42) | $ (1.21) |
Weighted average common shares outstanding, basic and diluted (in shares) | 92,777,480 | 92,569,993 | 92,414,644 | 88,897,292 | 82,323,393 | 77,445,675 | 69,664,994 | 64,562,236 | 91,677,963 | 73,558,548 | 59,436,649 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Millions | Mar. 04, 2020 | Mar. 03, 2020 | Mar. 01, 2020 | Dec. 31, 2019 |
Subsequent Event | ||||
Final fee payment | $ 1.9 | |||
Subsequent event | ||||
Subsequent Event | ||||
Additional compliance period | 180 days | 180 days | ||
Final fee payment | $ 1.9 | |||
Final payment fee percentage | 6.60% |