Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 05, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | TREVENA INC | |
Entity Central Index Key | 0001429560 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 92,567,195 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 23,826 | $ 32,892 |
Marketable securities | 30,140 | 28,590 |
Prepaid expenses and other current assets | 1,301 | 607 |
Total current assets | 55,267 | 62,089 |
Restricted cash | 1,306 | 1,303 |
Property and equipment, net | 2,982 | 3,387 |
Right-of-use lease asset | 5,629 | |
Total assets | 65,184 | 66,779 |
Current liabilities: | ||
Accounts payable | 403 | 1,416 |
Accrued expenses and other current liabilities | 2,416 | 3,295 |
Current portion of loans payable, net | 11,258 | 12,562 |
Lease liability | 581 | 10 |
Deferred rent | 207 | |
Total current liabilities | 14,658 | 17,490 |
Loans payable, net | 4,811 | |
Leases, net of current portion | 8,127 | 20 |
Deferred rent, net of current portion | 2,931 | |
Warrant liability | 7 | 1 |
Total liabilities | 22,792 | 25,253 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity: | ||
Common stock - $0.001 par value; 200,000,000 shares authorized; 92,567,195 and 82,323,413 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 92 | 82 |
Preferred stock - $0.001 par value; 5,000,000 shares authorized, none issued or outstanding at June 30, 2019 and December 31, 2018 | ||
Additional paid-in capital | 440,424 | 429,727 |
Accumulated deficit | (398,134) | (388,274) |
Accumulated other comprehensive loss | 10 | (9) |
Total stockholders' equity | 42,392 | 41,526 |
Total liabilities and stockholders' equity | $ 65,184 | $ 66,779 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 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) | 92,567,195 | 82,323,413 |
Common stock outstanding (in shares) | 92,567,195 | 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 | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue: | ||||
Total revenue | $ 2,500 | $ 2,500 | ||
Type of Revenue [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||||
General and administrative | $ 3,311 | $ 5,926 | $ 6,371 | $ 10,998 |
Research and development | 2,722 | 5,128 | 4,876 | 9,726 |
Restructuring charges | 41 | 64 | ||
Impairment of property and equipment | 108 | 108 | ||
Total operating expenses | 6,141 | 11,095 | 11,355 | 20,788 |
Loss from operations | (6,141) | (8,595) | (11,355) | (18,288) |
Other income (expense): | ||||
Change in fair value of warrant liability | 6 | 4 | (6) | 4 |
Net (loss) gain on asset disposals | (107) | 116 | ||
Other income, net | 1,616 | 500 | 1,873 | 1,428 |
Interest income | 98 | 226 | 251 | 425 |
Interest expense | (271) | (597) | (624) | (1,275) |
Gain on foreign currency exchange | 1 | 10 | 1 | 10 |
Total other income | 1,450 | 36 | 1,495 | 708 |
Loss before income tax expense | (4,691) | (8,559) | (9,860) | (17,580) |
Foreign income tax expense | (745) | (745) | ||
Net loss attributable to common stockholders | (4,691) | (9,304) | (9,860) | (18,325) |
Other comprehensive gain, net: | ||||
Unrealized gain on marketable securities | 7 | 26 | 19 | 22 |
Other comprehensive gain, net | 7 | 26 | 19 | 22 |
Comprehensive loss | $ (4,684) | $ (9,278) | $ (9,841) | $ (18,303) |
Per share information: | ||||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.05) | $ (0.13) | $ (0.11) | $ (0.27) |
Weighted average common shares outstanding, basic and diluted (in shares) | 92,414,644 | 69,664,994 | 90,665,684 | 67,127,711 |
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, 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 | 1,498 | 1,498 | |||
Exercise of stock options | 57 | 57 | |||
Exercise of stock options (in shares) | 88,048 | ||||
Issuance of common stock, net of issuance costs | $ 6 | 9,148 | 9,154 | ||
Issuance of common stock, net of issuance costs (in shares) | 5,204,893 | ||||
Unrealized gain on marketable securities | (4) | (4) | |||
Net loss | (9,021) | (9,021) | |||
Ending Balance at Mar. 31, 2018 | $ 68 | 402,806 | (366,511) | (46) | 36,317 |
Balance (in shares) at Mar. 31, 2018 | 67,603,736 | ||||
Beginning 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 | |||||
Net loss | (18,325) | ||||
Ending Balance at Jun. 30, 2018 | $ 74 | 414,457 | (375,815) | (20) | 38,696 |
Balance (in shares) at Jun. 30, 2018 | 73,507,985 | ||||
Beginning Balance at Dec. 31, 2017 | $ 62 | 392,103 | (357,490) | (42) | 34,633 |
Balance (in shares) at Dec. 31, 2017 | 62,310,795 | ||||
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 | |||
Beginning Balance at Mar. 31, 2018 | $ 68 | 402,806 | (366,511) | (46) | $ 36,317 |
Balance (in shares) at Mar. 31, 2018 | 67,603,736 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 1,287 | 1,287 | |||
Exercise of stock options | 26 | 26 | |||
Exercise of stock options (in shares) | 44,904 | ||||
Issuance of common stock, net of issuance costs | $ 6 | 10,338 | 10,344 | ||
Issuance of common stock, net of issuance costs (in shares) | 5,859,345 | ||||
Unrealized gain on marketable securities | 26 | 26 | |||
Net loss | (9,304) | (9,304) | |||
Ending Balance at Jun. 30, 2018 | $ 74 | 414,457 | (375,815) | (20) | 38,696 |
Balance (in shares) at Jun. 30, 2018 | 73,507,985 | ||||
Beginning 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 | 754 | $ 754 | |||
Exercise of stock options | 21 | 21 | |||
Exercise of stock options (in shares) | 30,225 | ||||
Issuance of warrants to underwriters in connection with equity offering | 347 | 347 | |||
Issuance of common stock, net of issuance costs | $ 10 | 8,886 | 8,896 | ||
Issuance of common stock, net of issuance costs (in shares) | 10,000,000 | ||||
Unrealized gain on marketable securities | 12 | 12 | |||
Net loss | (5,169) | (5,169) | |||
Ending Balance at Mar. 31, 2019 | $ 92 | 439,735 | (393,443) | 3 | 46,387 |
Balance (in shares) at Mar. 31, 2019 | 92,353,638 | ||||
Beginning 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 | |||||
Exercise of stock options (in shares) | 30,225 | ||||
Net loss | $ (9,860) | ||||
Ending Balance at Jun. 30, 2019 | $ 92 | 440,424 | (398,134) | 10 | $ 42,392 |
Balance (in shares) at Jun. 30, 2019 | 92,567,195 | 92,567,195 | |||
Beginning Balance at Mar. 31, 2019 | $ 92 | 439,735 | (393,443) | 3 | $ 46,387 |
Balance (in shares) at Mar. 31, 2019 | 92,353,638 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 793 | 793 | |||
Shares repurchased by the Company (in shares) | (122) | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | (104) | (104) | |||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 213,679 | ||||
Unrealized gain on marketable securities | 7 | 7 | |||
Net loss | (4,691) | (4,691) | |||
Ending Balance at Jun. 30, 2019 | $ 92 | $ 440,424 | $ (398,134) | $ 10 | $ 42,392 |
Balance (in shares) at Jun. 30, 2019 | 92,567,195 | 92,567,195 |
Statement of Stockholders' Equi
Statement of Stockholders' Equity (Parenthetical) - $ / shares | Jun. 30, 2019 | Jun. 30, 2018 |
Common Stock, Par or Stated Value Per Share | $ 0.001 | |
Common Stock | ||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities: | ||
Net loss | $ (9,860) | $ (18,325) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 297 | 340 |
Stock-based compensation | 1,547 | 2,785 |
Noncash interest expense on loans | 218 | 446 |
Impairment of property and equipment | 108 | |
Revaluation of warrant liability | 6 | (4) |
Accretion of bond discount on marketable securities | (348) | (25) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (720) | (2,400) |
Operating lease right of use asset and operating lease liabilities | (59) | |
Accounts payable, accrued expenses and other liabilities | (1,890) | (1,560) |
Deferred revenue | 3,000 | |
Net cash used in operating activities | (10,701) | (15,743) |
Investing activities: | ||
Purchases of property and equipment | (147) | |
Maturities of marketable securities | 40,179 | 32,550 |
Purchases of marketable securities | (41,362) | (22,422) |
Net cash provided by investing activities | (1,183) | 9,981 |
Financing activities: | ||
Proceeds from exercise of common stock options | 21 | 83 |
Proceeds from issuance of common stock, net | 9,243 | 19,498 |
Payment of employee withholding taxes on vested restricted stock units | (104) | |
Capital lease payments | (6) | |
Capital lease payments | (6) | |
Repayments of loans payable, net | (6,333) | (6,333) |
Net cash provided by financing activities | 2,821 | 13,242 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (9,063) | 7,480 |
Cash, cash equivalents and restricted cash - beginning of period | 34,195 | 17,970 |
Cash, cash equivalents and restricted cash - end of period | 25,132 | 25,450 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 406 | $ 827 |
Fair value of common stock warrants issued to underwriters | $ 347 |
Organization and Description of
Organization and Description of the Business | 6 Months Ended |
Jun. 30, 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, conditions. 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 preclinical studies and clinical trials. The Company has never been profitable and has not yet commenced commercial operations. On November 2, 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. On January 28, 2019, the Company announced the receipt of the official Type A meeting minutes from the FDA regarding the CRL wherein it agreed that the current oliceridine safety database will support labeling at a maximum daily dose of 27 mg. The FDA also agreed that the Company can 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 submitted a detailed protocol and analysis plan to the FDA and has received feedback from the FDA on key design elements for the study and analysis plan. The Company began the study in June 2019 and expects to report topline data in the fourth quarter of 2019. To address remaining items in the CRL, the FDA indicated that the Company should include supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the Company resubmits the oliceridine NDA. Since its inception, the Company has incurred losses and negative cash flows from operations. At June 30, 2019, the Company had an accumulated deficit of $398.1 million. The Company’s net loss was $9.9 million and $18.3 million for the six months ended June 30, 2019 and 2018, respectively. The Company expects its cash and cash equivalents of $23.8 million and marketable securities of $30.1 million as of June 30, 2019, together with interest thereon, to be sufficient to fund its operating expenses, debt service, and capital expenditure requirements for at least twelve months following the date of this filing, into the third quarter of 2020. 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 consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 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 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 Accounting Standards Codification, or ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB. The Company’s functional currency is the U.S. dollar. The financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s balance sheet as of June 30, 2019, its results of operations and its comprehensive loss for the three and six months ended June 30, 2019 and 2018, its statement of stockholders’ equity for the period from January 1, 2019 to June 30, 2019, and its cash flows for the six months ended June 30, 2019 and 2018. The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10‑K for the year ended December 31, 2018. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the six months ended June 30, 2019 and 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period. Leases The Company adopted ASU 2016‑02, Leases (Topic 842) , and all applicable amendments as of January 1, 2019 using a modified retrospective approach. The Company determines if an arrangement is a lease at inception. Operating leases are included in long-term right-of-use assets and current and long-term lease liabilities on our consolidated balance sheets. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The right-of-use assets are tested for impairment according to ASC 360. See Note 6 for details. Leases with an initial term of 12 months or less are not recorded on the balance sheet; we recognize lease expense for these immaterial leases on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component under the practical expedient provisions of the standard. Lease payments, which may include lease and non-lease components, are included in the measurement of the Company’s lease liabilities to the extent that such payments are either fixed amounts or variable amounts that depend on a rate or index as stipulated in the lease contract. 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) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company 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. 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; and royalties on net sales of licensed products. See Note 7. 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. 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. 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. Recently Adopted Accounting Standards In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income , which provides the option to reclassify stranded tax effects within accumulated other comprehensive income to retained earnings. This option would be available in each period in which the effect of the change in the U.S. federal corporate income tax rate in the TCJA (or a portion thereof) is recorded. This is effective for the Company beginning after December 15, 2018, with early adoption permitted. These amendments should be applied in the period of adoption or retrospectively to each period in which the effect of the change in the U.S federal corporate income tax rate in the TCJA is recognized. The adoption of this standard did not have an impact on the Company’s consolidated 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 right-of-use 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 our consolidated 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 to 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 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 | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments ASC 820, Fair Value Measurement, 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 and Marketable Securities The following table presents fair value of the Company’s cash, cash equivalents, and marketable securities as of June 30, 2019 and December 31, 2018 (in thousands): June 30, 2019 Adjusted Unrealized Unrealized Cash and Cash Restricted Marketable Cost Gains Losses Fair Value Equivalents Cash Securities Cash $ 7,818 $ — $ — $ 7,818 $ 6,512 $ 1,306 $ — Level 1 (1): Money market funds 14,318 — — 14,318 14,318 — — U.S. treasury securities 23,929 10 — 23,939 — — 23,939 Subtotal 38,247 10 — 38,257 14,318 — 23,939 Level 2 (2): U.S. government agency securities 9,197 — — 9,197 2,996 — 6,201 Total $ 55,262 $ 10 $ — $ 55,272 $ 23,826 $ 1,306 $ 30,140 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 of the assets or liabilities. The Company classifies investments available to fund current operations as current assets on its balance sheets. As of June 30, 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 during the three and six months ended June 30, 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. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers between Level 2 and Level 3 during the six months ended June 30, 2019 or the year ended December 31, 2018. |
Loans Payable
Loans Payable | 6 Months Ended |
Jun. 30, 2019 | |
Loans Payable | |
Loans Payable | 4. 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). 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. Borrowings under Term Loans A and B accrue interest at a fixed rate of 6.50% per annum. Borrowings under Term Loan C accrue 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 will continue to be due until the loan matures on March 1, 2020. As of June 30, 2019, there was $9.5 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 applicable maturity date, it will pay the lenders a prepayment fee of 1.0% of Term Loan C. The Company’s obligations under the loan and security agreement are 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 (together, the collateral). The Company has 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. 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 contains 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. Upon an event of default, the lenders have 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 agreement, the Company issued to the lenders and the placement agent warrants to purchase an aggregate of 7,678 shares of Trevena’s common stock, of which 5,728 shares remain outstanding as of June 30, 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 the Company’s 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 June 30, 2019, borrowings of $9.5 million attributable to Term Loans A, B, and C are outstanding. Interest expense of $0.4 million and $0.8 million was recorded during the six months ended June 30, 2019 and 2018, 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. Immaterial amounts of debt discount and debt issuance cost were amortized to interest expense during the three and six months ended June 30, 2019 and 2018, respectively. The following table summarizes how the issuance of Term Loans A, B, and C are reflected on the balance sheet at June 30, 2019 and December 31, 2018 (in thousands): June 30, December 31, 2019 2018 Gross proceeds $ 9,500 $ 15,833 Debt discount and debt issuance costs (1) 1,758 1,540 Carrying value 11,258 17,373 Current portion of loans payable, net 11,258 12,562 Loans payable, net $ — $ 4,811 (1) Includes the final fee payment due upon last payment date of the amounts borrowed. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | 5. Stockholders’ Equity Equity Offerings ATM Programs On December 14, 2015, the Company entered into an at the market, or ATM, sales agreement, or the Prior ATM 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. Sales under the Prior ATM Agreement are 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 Prior ATM Agreement, 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 Prior ATM Agreement at a weighted average price per share of $1.80. The net offering proceeds to the Company in 2018 for sales under the Prior ATM Agreement were approximately $20.0 million after deducting related expenses, including commissions. Sales of common stock under the Prior ATM Agreement terminated on June 29, 2018 when the Company’s Registration Statement on Form S-3 (File No. 333-225685), or the Shelf Registration Statement, was declared effective by the SEC. Accordingly, as of June 30, 2019, there was no remaining capacity available under this ATM sales facility. In June 2018, the Company filed a $175.0 million 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. Sales of the shares of common stock 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 this facility, at a weighted average share price of $1.60, which yielded net proceeds to the Company of approximately $13.2 million after deducting related expenses, including commissions. The Company terminated sales under this ATM sales facility on April 17, 2019, and the remaining capacity was added back to the aggregate amount available under the Shelf Registration Statement. Accordingly, as of June 30, 2019, there was no remaining capacity available under this ATM sales facility . 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 Current 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. The Company did not issue any shares through the Current ATM Program during the quarter ended June 30, 2019. As of June 30, 2019, there was $50.0 million remaining available for future issuances under the Current ATM Program. Private Placement 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 Company’s existing registration statement on Form S-3. 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 H.C. Wainwright & Co., LLC, or 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 on the Company’s Consolidated Balance Sheets 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 The Company utilizes equity incentive plans to grant various forms of stock options and restricted stock to eligible employees, directors and consultants to the Company. Under all of such 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. 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 stock-based awards is amortized on a straight-line basis over the awards’ service periods. Stock-based compensation expense recognized was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 192 $ 386 $ 424 $ 744 General and administrative 601 901 1,123 2,041 Total stock-based compensation $ 793 $ 1,287 $ 1,547 $ 2,785 Stock Options A summary of stock option activity and related information through June 30, 2019 follows: Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2018 8,265,207 $ 3.99 6.99 Granted 577,000 1.18 Exercised (30,225) 0.68 Forfeited/Cancelled (1,443,959) (5.19) Balance, June 30, 2019 7,368,023 $ 3.55 7.31 Vested or expected to vest at June 30, 2019 7,368,023 $ 3.55 7.31 Exercisable at June 30, 2019 4,015,174 $ 4.49 6.11 The intrinsic value of the options exercisable as of June 30, 2019 was $0.1 million, based on the Company’s closing stock price of $1.03 per share and a weighted average exercise price of $4.49 per share. At June 30, 2019, there was $4.1 million of total unrecognized compensation expense related to unvested options that will be recognized over the weighted average remaining period of 1.95 years. 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 common 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 common stock. The per-share weighted-average grant date fair value of the options granted to employees and directors during the six months ended June 30, 2019 and 2018 was estimated at $0.73 and $1.19 per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: June 30, 2019 2018 Expected term of options (in years) 5.9 5.8 Risk-free interest rate 2.0 % 2.7 % Expected volatility 69.1 % 74.9 % Dividend yield 0 % 0 % Restricted Stock Units On December 6, 2018, the Company granted 1,255,000 restricted stock unit awards, or RSUs, to employees. The units vest subject to the satisfaction of service requirements as follows: 25% vested on June 1, 2019, 25% vest on December 1, 2019, and the remaining vest on December 6, 2021. The closing price of the Company’s common stock on the date of the grant was $0.64 per share, which is the fair market value per unit of the RSUs. 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 88,821 shares of common stock underlying exercised, vested RSUs that were withheld during the six months ended June 30, 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 during the year: RSUs Outstanding Weighted Average Number of Grant Date Awards Fair Value Non-vested at December 31, 2018 1,255,000 $ 0.65 Granted 330,000 0.89 Vested (302,500) 0.65 Forfeited (100,000) 0.65 Non-vested at June 30, 2019 1,182,500 $ 0.72 For the six months ended June 30, 2019, the Company recorded $0.2 million in stock-based compensation expense related to RSUs, which is reflected in the statement of operations. As of June 30, 2019, there was $0.8 million of total unrecognized compensation expense related to unvested restricted stock units that will be recognized over the weighted average remaining period of 2.26 years. Shares Available for Future Grant At June 30, 2019, the Company has the following shares available to be granted under its equity incentive plans: Inducement 2013 Plan Plan Available at December 31, 2018 2,603,983 144,125 Authorized 3,381,757 — Granted (907,000) — Forfeited/Cancelled 1,530,584 13,375 Available at June 30, 2019 6,609,324 157,500 Shares Reserved for Future Issuance At June 30, 2019, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 7,025,523 Restricted stock units outstanding under 2013 Plan 1,182,500 Shares available for future grant under 2013 Plan 6,609,324 Stock options outstanding under Inducement Plan 342,500 Shares available for future grant under Inducement Plan 157,500 Employee stock purchase plan 225,806 Warrants outstanding 623,091 Total shares of common stock reserved for future issuance 16,166,244 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 6. Commitments and Contingencies Leases We lease office space in Chesterbrook, Pennsylvania and equipment. We sublease the second floor of our Chesterbrook, Pennsylvania office space to a third party. Rent expense and associated sublease income are recorded in the Company’s statements of operations and comprehensive loss as other income (expense). Supplemental balance sheet information related to leases was as follows (in thousands): June 30, 2019 December 31, 2018 Operating Leases Operating lease right-of-use assets $ 5,629 $ — Other current liabilities 572 — Operating lease liabilities 8,111 — Total operating lease liabilities $ 8,683 $ — Finance Leases Property and equipment, at cost $ 45 $ 59 Accumulated depreciation (20) (29) Property and equipment, net 25 30 Other current liabilities 9 10 Other long-term liabilities 16 20 Total finance lease liabilities $ 25 $ 30 The components of lease expense were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Operating lease costs: Operating lease rental expense $ 306 $ 345 $ 613 $ 798 Other income (301) — (629) — Total operating lease costs $ 5 $ 345 $ (16) $ 798 Finance lease costs: Amortization of right-of-use assets Interest on lease liabilities — — Total finance lease costs $ 3 $ 3 $ 7 $ 7 Supplemental cash flow information related to leases was as follows (in thousands): Six Months Ended June 30, 2019 2018 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (43) $ (798) Operating cash flows from finance leases (1) — Financing cash flows from finance leases (6) (6) Our operating lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2019 (July 1 - December 31) $ 669 $ 5 2020 1,352 10 2021 1,376 8 2022 1,401 4 2023 1,425 — 2024 and beyond 6,586 — Total minimum lease payments $ 12,809 $ 27 Interest Expense (4,126) (2) Lease liability $ 8,683 $ 25 Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2019 (July 1 - December 31) $ 537 2020 1,078 2021 944 2022 — 2023 — 2024 and beyond — Total minimum lease payments $ 2,559 Lease term and discount rates are as follows: Six Months Ended June 30, 2019 2018 Weighted average remaining lease term (years) Operating leases 9 10 Finance leases 2 3 Weighted average discount rate Operating leases Finance 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 it intends to vigorously defend itself against the allegations. 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. These cases, which involve similar facts as 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 | 6 Months Ended |
Jun. 30, 2019 | |
Licensing Arrangements | |
Licensing Arrangements | 7. 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. 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 and the Company and Nhwa expect to enter into a separate agreement. 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. |
Net Loss Per Common Share
Net Loss Per Common Share | 6 Months Ended |
Jun. 30, 2019 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 8. 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): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Basic and diluted net loss per common share calculation: Net loss $ (4,691) $ (9,304) $ (9,860) $ (18,325) Net loss attributable to common stockholders $ (4,691) $ (9,304) $ (9,860) $ (18,325) Weighted average common shares outstanding 92,414,644 69,664,994 90,665,684 67,127,711 Net loss per share of common stock - basic and diluted $ (0.05) $ (0.13) $ (0.11) $ (0.27) The following outstanding securities at June 30, 2019 and 2018 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: June 30, 2019 2018 Options outstanding 7,368,023 9,385,448 Restricted stock units outstanding 1,182,500 — Warrants 623,091 123,091 Total 9,173,614 9,508,539 |
Other Comprehensive Loss
Other Comprehensive Loss | 6 Months Ended |
Jun. 30, 2019 | |
Other Comprehensive Loss | |
Other Comprehensive Loss | 9. Other Comprehensive Loss The following table presents changes in the components of accumulated other comprehensive loss (in thousands): Balance, December 31, 2018 $ (9) Net unrealized gain on marketable securities 19 Balance, June 30, 2019 $ 10 There were no reclassifications out of accumulated other comprehensive loss during the six months ended June 30, 2019 and 2018. There was no tax effect during the three and six months ended June 30, 2019 and 2018. |
Restructuring Charges
Restructuring Charges | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring Charges | |
Restructuring Charges | 10. 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 recorded restructuring charges of approximately $1.4 million in the fourth quarter of 2018, all of which resulted in future cash outlays, primarily related to severance costs and benefit-related expenses. The following table summarizes the restructuring balances at June 30, 2019 and 2018 (in thousands): Six Months Ended June 30, 2019 2018 Balance, January 1 $ 1,419 $ 1,077 Current year restructuring costs — — Payment of employee severance costs (1,419) (897) Balance, June 30 $ — $ 180 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 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 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 Accounting Standards Codification, or ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB. The Company’s functional currency is the U.S. dollar. The financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s balance sheet as of June 30, 2019, its results of operations and its comprehensive loss for the three and six months ended June 30, 2019 and 2018, its statement of stockholders’ equity for the period from January 1, 2019 to June 30, 2019, and its cash flows for the six months ended June 30, 2019 and 2018. The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10‑K for the year ended December 31, 2018. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the six months ended June 30, 2019 and 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period. |
Leases | Leases The Company adopted ASU 2016‑02, Leases (Topic 842) , and all applicable amendments as of January 1, 2019 using a modified retrospective approach. The Company determines if an arrangement is a lease at inception. Operating leases are included in long-term right-of-use assets and current and long-term lease liabilities on our consolidated balance sheets. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The right-of-use assets are tested for impairment according to ASC 360. See Note 6 for details. Leases with an initial term of 12 months or less are not recorded on the balance sheet; we recognize lease expense for these immaterial leases on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component under the practical expedient provisions of the standard. Lease payments, which may include lease and non-lease components, are included in the measurement of the Company’s lease liabilities to the extent that such payments are either fixed amounts or variable amounts that depend on a rate or index as stipulated in the lease contract. |
Revenue | 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) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company 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. 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; and royalties on net sales of licensed products. See Note 7. 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. 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. |
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. |
Recent Accounting Pronouncements | Recently Adopted Accounting Standards In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income , which provides the option to reclassify stranded tax effects within accumulated other comprehensive income to retained earnings. This option would be available in each period in which the effect of the change in the U.S. federal corporate income tax rate in the TCJA (or a portion thereof) is recorded. This is effective for the Company beginning after December 15, 2018, with early adoption permitted. These amendments should be applied in the period of adoption or retrospectively to each period in which the effect of the change in the U.S federal corporate income tax rate in the TCJA is recognized. The adoption of this standard did not have an impact on the Company’s consolidated 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 right-of-use 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 our consolidated 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 to 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 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) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value of Financial Instruments | |
Schedule of cash, cash equivalents and marketable securities | The following table presents fair value of the Company’s cash, cash equivalents, and marketable securities as of June 30, 2019 and December 31, 2018 (in thousands): June 30, 2019 Adjusted Unrealized Unrealized Cash and Cash Restricted Marketable Cost Gains Losses Fair Value Equivalents Cash Securities Cash $ 7,818 $ — $ — $ 7,818 $ 6,512 $ 1,306 $ — Level 1 (1): Money market funds 14,318 — — 14,318 14,318 — — U.S. treasury securities 23,929 10 — 23,939 — — 23,939 Subtotal 38,247 10 — 38,257 14,318 — 23,939 Level 2 (2): U.S. government agency securities 9,197 — — 9,197 2,996 — 6,201 Total $ 55,262 $ 10 $ — $ 55,272 $ 23,826 $ 1,306 $ 30,140 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 of the assets or liabilities. |
Loans Payable (Tables)
Loans Payable (Tables) | 6 Months Ended |
Jun. 30, 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 June 30, 2019 and December 31, 2018 (in thousands): June 30, December 31, 2019 2018 Gross proceeds $ 9,500 $ 15,833 Debt discount and debt issuance costs (1) 1,758 1,540 Carrying value 11,258 17,373 Current portion of loans payable, net 11,258 12,562 Loans payable, net $ — $ 4,811 (1) Includes the final fee payment due upon last payment date of the amounts borrowed. |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity | |
Schedule of share-based compensation expense recognized | The estimated grant-date fair value of the Company’s stock-based awards is amortized on a straight-line basis over the awards’ service periods. Stock-based compensation expense recognized was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 192 $ 386 $ 424 $ 744 General and administrative 601 901 1,123 2,041 Total stock-based compensation $ 793 $ 1,287 $ 1,547 $ 2,785 |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2018 8,265,207 $ 3.99 6.99 Granted 577,000 1.18 Exercised (30,225) 0.68 Forfeited/Cancelled (1,443,959) (5.19) Balance, June 30, 2019 7,368,023 $ 3.55 7.31 Vested or expected to vest at June 30, 2019 7,368,023 $ 3.55 7.31 Exercisable at June 30, 2019 4,015,174 $ 4.49 6.11 |
Schedule of weighted-average assumptions: | June 30, 2019 2018 Expected term of options (in years) 5.9 5.8 Risk-free interest rate 2.0 % 2.7 % Expected volatility 69.1 % 74.9 % Dividend yield 0 % 0 % |
Schedule of changes in the status of non-vested RSU | RSUs Outstanding Weighted Average Number of Grant Date Awards Fair Value Non-vested at December 31, 2018 1,255,000 $ 0.65 Granted 330,000 0.89 Vested (302,500) 0.65 Forfeited (100,000) 0.65 Non-vested at June 30, 2019 1,182,500 $ 0.72 |
Schedule of shares available to be granted under equity incentive plans | At June 30, 2019, the Company has the following shares available to be granted under its equity incentive plans: Inducement 2013 Plan Plan Available at December 31, 2018 2,603,983 144,125 Authorized 3,381,757 — Granted (907,000) — Forfeited/Cancelled 1,530,584 13,375 Available at June 30, 2019 6,609,324 157,500 |
Schedule of shares of common stock reserved/available | At June 30, 2019, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 7,025,523 Restricted stock units outstanding under 2013 Plan 1,182,500 Shares available for future grant under 2013 Plan 6,609,324 Stock options outstanding under Inducement Plan 342,500 Shares available for future grant under Inducement Plan 157,500 Employee stock purchase plan 225,806 Warrants outstanding 623,091 Total shares of common stock reserved for future issuance 16,166,244 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies. | |
Schedule of balance sheet information related to leases | June 30, 2019 December 31, 2018 Operating Leases Operating lease right-of-use assets $ 5,629 $ — Other current liabilities 572 — Operating lease liabilities 8,111 — Total operating lease liabilities $ 8,683 $ — Finance Leases Property and equipment, at cost $ 45 $ 59 Accumulated depreciation (20) (29) Property and equipment, net 25 30 Other current liabilities 9 10 Other long-term liabilities 16 20 Total finance lease liabilities $ 25 $ 30 |
Schedule of components of lease expense | Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Operating lease costs: Operating lease rental expense $ 306 $ 345 $ 613 $ 798 Other income (301) — (629) — Total operating lease costs $ 5 $ 345 $ (16) $ 798 Finance lease costs: Amortization of right-of-use assets Interest on lease liabilities — — Total finance lease costs $ 3 $ 3 $ 7 $ 7 |
Schedule of cash flow information | Six Months Ended June 30, 2019 2018 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (43) $ (798) Operating cash flows from finance leases (1) — Financing cash flows from finance leases (6) (6) |
Schedule of maturities of operating lease liabilities | Operating Leases Financing Leases 2019 (July 1 - December 31) $ 669 $ 5 2020 1,352 10 2021 1,376 8 2022 1,401 4 2023 1,425 — 2024 and beyond 6,586 — Total minimum lease payments $ 12,809 $ 27 Interest Expense (4,126) (2) Lease liability $ 8,683 $ 25 |
Schedule of maturities of financing lease liabilities | Operating Leases Financing Leases 2019 (July 1 - December 31) $ 669 $ 5 2020 1,352 10 2021 1,376 8 2022 1,401 4 2023 1,425 — 2024 and beyond 6,586 — Total minimum lease payments $ 12,809 $ 27 Interest Expense (4,126) (2) Lease liability $ 8,683 $ 25 |
Schedule of expected sublease inflows | Sublease 2019 (July 1 - December 31) $ 537 2020 1,078 2021 944 2022 — 2023 — 2024 and beyond — Total minimum lease payments $ 2,559 |
Schedule of lease term and discount rates | Six Months Ended June 30, 2019 2018 Weighted average remaining lease term (years) Operating leases 9 10 Finance leases 2 3 Weighted average discount rate Operating leases Finance leases |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 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): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Basic and diluted net loss per common share calculation: Net loss $ (4,691) $ (9,304) $ (9,860) $ (18,325) Net loss attributable to common stockholders $ (4,691) $ (9,304) $ (9,860) $ (18,325) Weighted average common shares outstanding 92,414,644 69,664,994 90,665,684 67,127,711 Net loss per share of common stock - basic and diluted $ (0.05) $ (0.13) $ (0.11) $ (0.27) |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | June 30, 2019 2018 Options outstanding 7,368,023 9,385,448 Restricted stock units outstanding 1,182,500 — Warrants 623,091 123,091 Total 9,173,614 9,508,539 |
Other Comprehensive Loss (Table
Other Comprehensive Loss (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Other Comprehensive 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 loss (in thousands): Balance, December 31, 2018 $ (9) Net unrealized gain on marketable securities 19 Balance, June 30, 2019 $ 10 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring Charges | |
Schedule of restructuring balances | The following table summarizes the restructuring balances at June 30, 2019 and 2018 (in thousands): Six Months Ended June 30, 2019 2018 Balance, January 1 $ 1,419 $ 1,077 Current year restructuring costs — — Payment of employee severance costs (1,419) (897) Balance, June 30 $ — $ 180 |
Organization and Description _2
Organization and Description of the Business (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Organization and Description of the Business | |||||||
Number of operating segments | 1 | ||||||
Accumulated deficit | $ (398,134,000) | $ (398,134,000) | $ (388,274,000) | ||||
Net loss | (4,691,000) | $ (5,169,000) | $ (9,304,000) | $ (9,021,000) | (9,860,000) | $ (18,325,000) | |
Cash and cash equivalents | 23,826,000 | 23,826,000 | 32,892,000 | ||||
Marketable securities | $ 30,140,000 | $ 30,140,000 | $ 28,590,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Millions | Jan. 01, 2019 | Jun. 30, 2019 |
Restricted Cash | ||
Letter of credit collateral | $ 1.3 | |
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 | $ 5.7 | |
Lease liabilities | $ 8.8 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Hierarchy Table (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Fair value | ||
Unrealized Gains | $ 10 | |
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 | 7,818 | 10,992 |
Assets, Fair Value Disclosure | 55,262 | 62,794 |
Fair Value | ||
Fair value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 7,818 | 10,992 |
Assets, Fair Value Disclosure | 55,272 | 62,785 |
Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 6,512 | 9,689 |
Assets, Fair Value Disclosure | 23,826 | 32,892 |
Restricted Cash | Fair Value | ||
Fair value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 1,306 | 1,303 |
Assets, Fair Value Disclosure | 1,306 | 1,303 |
Marketable Securities | Fair Value | ||
Fair value | ||
Assets, Fair Value Disclosure | 30,140 | 28,590 |
Level 1 | ||
Fair value | ||
Unrealized Gains | 10 | |
Unrealized Losses | (4) | |
Level 1 | Adjusted cost | ||
Fair value | ||
Investments, Fair Value Disclosure | 38,247 | 42,141 |
Level 1 | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 38,257 | 42,137 |
Level 1 | Money market funds | Adjusted cost | ||
Fair value | ||
Investments, Fair Value Disclosure | 14,318 | 23,203 |
Level 1 | Money market funds | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 14,318 | 23,203 |
Level 1 | U.S. treasury securities | ||
Fair value | ||
Unrealized Gains | 10 | |
Unrealized Losses | (4) | |
Level 1 | U.S. treasury securities | Adjusted cost | ||
Fair value | ||
Investments, Fair Value Disclosure | 23,929 | 18,938 |
Level 1 | U.S. treasury securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 23,939 | 18,934 |
Level 1 | Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 14,318 | 23,203 |
Level 1 | Cash and Cash Equivalents | Money market funds | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 14,318 | 23,203 |
Level 1 | Marketable Securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 23,939 | 18,934 |
Level 1 | Marketable Securities | U.S. treasury securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 23,939 | 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 | 9,197 | 9,661 |
Level 2 | U.S. government agency securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 9,197 | 9,656 |
Level 2 | Cash and Cash Equivalents | U.S. government agency securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | 2,996 | |
Level 2 | Marketable Securities | U.S. government agency securities | Fair Value | ||
Fair value | ||
Investments, Fair Value Disclosure | $ 6,201 | $ 9,656 |
Loans Payable (Details)
Loans Payable (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Dec. 31, 2015USD ($)item$ / sharesshares | Sep. 30, 2014USD ($)tranche$ / sharesshares | Jun. 30, 2019USD ($)$ / sharesshares | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)$ / sharesshares | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Long Term Debt | |||||||||
Interest expense | $ 271 | $ 597 | $ 624 | $ 1,275 | |||||
Loan and security agreement | |||||||||
Long Term Debt | |||||||||
Maximum amount available | $ 35,000 | ||||||||
Debt number of tranches | tranche | 3 | ||||||||
Gross proceeds | $ 9,500 | $ 9,500 | $ 15,833 | ||||||
Final payment fee | 6.60% | ||||||||
Interest expense | $ 400 | $ 800 | |||||||
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% | 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 | 5,728 | ||||||
Exercise price | $ / shares | $ 5.861 | ||||||||
Term Loan B | |||||||||
Long Term Debt | |||||||||
Face amount | $ 16,500 | ||||||||
Interest rate (as a percent) | 6.50% | 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 | ||||||||
Remaining amount available | $ 16,500 | $ 10,000 | |||||||
Interest rate (as a percent) | 6.98% | 6.98% | |||||||
Prepayment fee percent | 1.00% | ||||||||
Term Loan C | Minimum | |||||||||
Long Term Debt | |||||||||
Number of specified triggers needed to be satisfied to draw on loan | item | 1 | ||||||||
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 | 62,241 | |||||||
Exercise price | $ / shares | $ 3.6150 | $ 3.6150 |
Loans Payable Schedule of Debt
Loans Payable Schedule of Debt (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Long Term Debt | ||
Current portion of loans payable, net | $ 11,258 | $ 12,562 |
Loans payable, net | 4,811 | |
Loan and security agreement | ||
Long Term Debt | ||
Gross proceeds | 9,500 | 15,833 |
Debt discount and debt issuance costs | 1,758 | 1,540 |
Carrying value | 11,258 | 17,373 |
Current portion of loans payable, net | $ 11,258 | 12,562 |
Loans payable, net | $ 4,811 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings (Details) | Jan. 29, 2019USD ($)Institution$ / sharesshares | Jan. 28, 2019USD ($)$ / sharesshares | Dec. 14, 2015USD ($) | Mar. 31, 2019USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Jun. 30, 2019USD ($)$ / sharesshares | Apr. 17, 2019USD ($) |
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 | |||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||||||
Offering price (in dollars per share) | $ / shares | $ 1 | ||||||||
Issuance of common stock, net of issuance costs | $ 8,896,000 | $ 10,344,000 | $ 9,154,000 | ||||||
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 - December 14, 2015 agreement | Weighted-average | |||||||||
Stockholders' Equity | |||||||||
Offering price (in dollars per share) | $ / shares | $ 1.80 | ||||||||
At-the-market sales facility - June 2018 agreement | |||||||||
Stockholders' Equity | |||||||||
Offering amount | 50,000,000 | 0 | |||||||
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 - June 2018 agreement | Maximum | |||||||||
Stockholders' Equity | |||||||||
Offering amount | $ 175,000,000 | ||||||||
At-the-market sales facility - June 2018 agreement | Weighted-average | |||||||||
Stockholders' Equity | |||||||||
Offering price (in dollars per share) | $ / shares | $ 1.60 | ||||||||
At-the-market sales facility - April 17, 2019 agreement | |||||||||
Stockholders' Equity | |||||||||
Offering amount | $ 50,000,000 | ||||||||
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 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plans (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Equity Incentive Plans | ||||
Stock-based compensation | $ 793 | $ 1,287 | $ 1,547 | $ 2,785 |
Research and Development Expense | ||||
Equity Incentive Plans | ||||
Stock-based compensation | 192 | 386 | 424 | 744 |
General and Administrative Expense | ||||
Equity Incentive Plans | ||||
Stock-based compensation | $ 601 | $ 901 | $ 1,123 | $ 2,041 |
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 Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 8,265,207 | |
Granted (in shares) | 577,000 | |
Exercised (in shares) | (30,225) | |
Forfeited/Cancelled (in shares) | (1,443,959) | |
Balance at the end of the period (in shares) | 7,368,023 | 8,265,207 |
Vested or expected to vest at the end of the period (in shares) | 7,368,023 | |
Exercisable at the end of the period (in shares) | 4,015,174 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 3.99 | |
Granted (in dollars per share) | 1.18 | |
Exercised (in dollars per share) | 0.68 | |
Forfeited/Cancelled (in dollars per share) | (5.19) | |
Balance at the end of the period (in dollars per share) | 3.55 | $ 3.99 |
Vested or expected to vest at the end of the period (in dollars per share) | 3.55 | |
Exercisable at the end of the period (in dollars per share) | $ 4.49 | |
Weighted Average Remaining Contractual Term | ||
Options Outstanding at the end of the period | 7 years 3 months 22 days | 6 years 11 months 27 days |
Vested or expected to vest at the end of the period | 7 years 3 months 22 days | |
Exercisable at the end of the period | 6 years 1 month 10 days | |
Intrinsic value of options exercisable | $ 0.1 | |
Offering price | $ 1.03 |
Stockholders' Equity - Option_2
Stockholders' Equity - Options Other Info (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Options outstanding | ||
Intrinsic value of options exercisable | $ 0.1 | |
Offering price | $ 1.03 | |
Exercisable at the end of the period (in dollars per share) | $ 4.49 | |
Employee Stock Option | ||
Options outstanding | ||
Unrecognized compensation expense | $ 4.1 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 1 year 11 months 12 days | |
Per-share weighted-average grant date fair value of options granted (in dollars per share) | $ 0.73 | $ 1.19 |
Employee Stock Option | Weighted-average | ||
Weighted-average assumptions: | ||
Expected term of options (in years) | 5 years 10 months 24 days | 5 years 9 months 18 days |
Risk-free interest rate (as a percent) | 2.00% | 2.70% |
Expected volatility (as a percent) | 69.10% | 74.90% |
Dividend yield (as a percent) | 0.00% | 0.00% |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 06, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 |
Stockholders' Equity | |||||
Offering price | $ 1.03 | $ 1.03 | |||
Shares underlying exercised | 88,821 | ||||
Stock-based compensation | $ 793 | $ 1,287 | $ 1,547 | $ 2,785 | |
Restricted Stock Units | |||||
Stockholders' Equity | |||||
Number of shares granted | 1,255,000 | 330,000 | |||
Offering price | $ 0.64 | ||||
Stock-based compensation | $ 200 | ||||
Restricted Stock Units | Vest on June 1, 2019 | |||||
Stockholders' Equity | |||||
Vesting percentage | 25.00% | ||||
Restricted Stock Units | Vest on December 1, 2019 | |||||
Stockholders' Equity | |||||
Vesting percentage | 25.00% |
Stockholders' Equity - Non-vest
Stockholders' Equity - Non-vested RSUs (Details) - Restricted Stock Units - USD ($) $ / shares in Units, $ in Millions | Dec. 06, 2018 | Jun. 30, 2019 |
Number of Shares | ||
Non-vested at beginning of period (in shares) | 1,255,000 | |
Granted (in shares) | 1,255,000 | 330,000 |
Vested (in shares) | (302,500) | |
Forfeited (in shares) | (100,000) | |
Non-vested at end of period (in shares) | 1,182,500 | |
Weighted Average Grant Date Fair Value | ||
Non-vested at beginning of period (in dollars per share) | $ 0.65 | |
Granted (in dollars per share) | 0.89 | |
Vested (in dollars per share) | 0.65 | |
Forfeited (in dollars per share) | 0.65 | |
Non-vested at end of period (in dollars per share) | $ 0.72 | |
Unrecognized compensation expense | $ 0.8 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 3 months 4 days |
Stockholder's Equity - Shares R
Stockholder's Equity - Shares Reserved for Future Grant Issuance (Details) - shares | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2019 | Dec. 31, 2018 | |
Shares Reserved for Future Issuance | |||
Stock options outstanding (in shares) | 7,368,023 | 8,265,207 | |
Warrants outstanding (in shares) | 623,091 | ||
Total shares of common stock reserved for issuance (in shares) | 16,166,244 | ||
2013 plan | |||
Shares Available for Future Grant | |||
Balance at the beginning of the period (in shares) | 2,603,983 | ||
Authorized (in shares) | 3,381,757 | ||
Granted (in shares) | (907,000) | ||
Forfeitures/Expirations (in shares) | 1,530,584 | ||
Balance at the end of the period (in shares) | 6,609,324 | ||
Shares Reserved for Future Issuance | |||
Shares available for future grant (in shares) | 2,603,983 | 6,609,324 | 2,603,983 |
Inducement Plan | |||
Shares Available for Future Grant | |||
Balance at the beginning of the period (in shares) | 144,125 | ||
Forfeitures/Expirations (in shares) | 13,375 | ||
Balance at the end of the period (in shares) | 157,500 | ||
Shares Reserved for Future Issuance | |||
Shares available for future grant (in shares) | 144,125 | 157,500 | 144,125 |
Employee Stock Purchase Plan [Member] | |||
Shares Reserved for Future Issuance | |||
Total shares of common stock reserved for issuance (in shares) | 225,806 | ||
Employee Stock Option | 2013 plan | |||
Shares Reserved for Future Issuance | |||
Stock options outstanding (in shares) | 7,025,523 | ||
Employee Stock Option | Inducement Plan | |||
Shares Reserved for Future Issuance | |||
Stock options outstanding (in shares) | 342,500 | ||
Restricted Stock Units | 2013 plan | |||
Shares Reserved for Future Issuance | |||
Total shares of common stock reserved for issuance (in shares) | 1,182,500 |
Commitments and Contingencies -
Commitments and Contingencies - Balance sheet information related to leases (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ 5,629 | |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OperatingLeaseRightOfUseAsset | |
Operating lease liabilities - Current | $ 572 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Operating lease liabilities - Noncurrent | $ 8,111 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OperatingLeaseLiabilityNoncurrent | |
Lease Liability | $ 8,683 | |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent us-gaap:OperatingLeaseLiabilityNoncurrent | |
Property and equipment, net | $ 2,982 | $ 3,387 |
Finance lease liabilities - Current | $ 9 | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Finance lease liabilities - Noncurrent | $ 16 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | |
Lease Liability | $ 25 | |
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 | (20) | |
Property and equipment, net | $ 25 | |
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_2
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating lease costs: | ||||
Operating lease rental expense | $ 306 | $ 613 | ||
Sublease income | (301) | (629) | ||
Total operating lease costs | 5 | (16) | ||
Finance lease costs: | ||||
Amortization of right-of-use assets | 3 | 6 | ||
Interest on lease liabilities | 1 | |||
Total finance lease costs | $ 3 | $ 7 | ||
Operating lease costs: | ||||
Operating lease rental expense | $ 345 | $ 798 | ||
Total operating lease costs | 345 | 798 | ||
Finance lease costs: | ||||
Amortization of right-of-use assets | 3 | 6 | ||
Interest on lease liabilities | 1 | |||
Total finance lease costs | $ 3 | $ 7 |
Commitments and Contingencies_3
Commitments and Contingencies - Cash flow information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ (43) | |
Operating cash flows from operating leases, pre-adoption | $ (798) | |
Operating cash flows from finance leases | (1) | |
Financing cash flows from finance leases | $ (6) | |
Financing cash flows from finance leases, pre-adoption | $ (6) |
Commitments and Contingencies_4
Commitments and Contingencies - Lease liabilities (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Operating Leases | |
2019 (July 1 - December 31) | $ 669 |
2020 | 1,352 |
2021 | 1,376 |
2022 | 1,401 |
2023 | 1,425 |
2024 and beyond | 6,586 |
Total minimum lease payments | 12,809 |
Interest Expense | (4,126) |
Lease Liability | 8,683 |
Financing Leases | |
2019 (July 1 - December 31) | 5 |
2020 | 10 |
2021 | 8 |
2022 | 4 |
Total minimum lease payments | 27 |
Interest Expense | (2) |
Lease Liability | 25 |
Sublease | |
2019 (July 1 - December 31) | 537 |
2020 | 1,078 |
2021 | 944 |
Total minimum lease payments | $ 2,559 |
Commitments and Contingencies_5
Commitments and Contingencies - Lease term and discount rates (Details) | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2019 | |
Commitments and Contingencies. | ||
Weighted average remaining lease term - Operating leases | 9 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 | 10 years | |
Weighted average remaining lease term - Finance leases | 3 years | |
Weighted average discount rate - Operating leases | 0.00% | |
Weighted average discount rate - Finance leases | 6.50% |
Commitments and Contingencies_6
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) - Licensing agreements for development and commercialization $ 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 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Basic and diluted net loss per common share calculation: | ||||||
Net loss | $ (4,691) | $ (5,169) | $ (9,304) | $ (9,021) | $ (9,860) | $ (18,325) |
Net loss attributable to common stockholders | $ (4,691) | $ (9,304) | $ (9,860) | $ (18,325) | ||
Weighted average common shares outstanding (in shares) | 92,414,644 | 69,664,994 | 90,665,684 | 67,127,711 | ||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.05) | $ (0.13) | $ (0.11) | $ (0.27) | ||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 9,173,614 | 9,508,539 | ||||
Employee Stock Option | ||||||
Basic and diluted net loss per common share calculation: | ||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 7,368,023 | 9,385,448 | ||||
Restricted Stock Units | ||||||
Basic and diluted net loss per common share calculation: | ||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 1,182,500 | |||||
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 |
Other Comprehensive Loss (Detai
Other Comprehensive Loss (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Other Comprehensive Loss | ||
Beginning Balance | $ 41,526,000 | $ 34,633,000 |
Ending Balance | 42,392,000 | 38,696,000 |
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 | (9,000) | (42,000) |
Net unrealized gain (loss) on marketable securities | 19,000 | |
Ending Balance | $ 10,000 | $ (20,000) |
Restructuring Charges (Details)
Restructuring Charges (Details) $ in Thousands | Nov. 08, 2018employee | Dec. 31, 2018USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) |
Summary of restructuring balances | |||||
Beginning balance | $ 1,419 | $ 1,077 | |||
Current year restructuring costs | $ 41 | 64 | |||
Payment of employee severance costs | $ (1,419) | (897) | |||
Ending balance | $ 1,419 | $ 180 | $ 180 | ||
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 |