Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 03, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | GENOCEA BIOSCIENCES, INC. | |
Entity Central Index Key | 1,457,612 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding (in shares) | 28,381,959 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 26,417,000 | $ 17,259,000 |
Investments, current portion | 49,044,000 | 77,069,000 |
Prepaid expenses and other current assets | 950,000 | 865,000 |
Total current assets | 76,411,000 | 95,193,000 |
Property and equipment, net | 5,034,000 | 4,083,000 |
Restricted cash | 316,000 | 316,000 |
Investments, net of current portion | 0 | 12,104,000 |
Other non-current assets | 1,108,000 | 446,000 |
Total assets | 82,869,000 | 112,142,000 |
Current liabilities: | ||
Accounts payable | 1,888,000 | 1,757,000 |
Accrued expenses and other current liabilities | 3,641,000 | 3,975,000 |
Deferred revenue | 0 | 235,000 |
Current portion of long-term debt | 1,559,000 | |
Total current liabilities | 7,088,000 | 5,967,000 |
Non-current liabilities: | ||
Long-term debt | 15,274,000 | 16,477,000 |
Other non-current liabilities | 158,000 | 37,000 |
Total liabilities | 22,520,000 | 22,481,000 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Common stock | 28,000 | 28,000 |
Additional paid-in-capital | 251,762,000 | 247,550,000 |
Accumulated other comprehensive income (loss) | 8,000 | (7,000) |
Accumulated deficit | (191,449,000) | (157,910,000) |
Total stockholders’ equity | 60,349,000 | 89,661,000 |
Total liabilities and stockholders’ equity | $ 82,869,000 | $ 112,142,000 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Income Statement [Abstract] | ||||
Grant revenue | $ 0 | $ 213 | $ 235 | $ 449 |
Document Fiscal Year Focus | 2,016 | |||
Operating expenses: | ||||
Research and development | 8,811 | 6,058 | $ 22,821 | 21,536 |
General and administrative | 3,619 | 3,645 | 11,569 | 10,206 |
Refund of research and development expense | 0 | 0 | (1,592) | 0 |
Total operating expenses | 12,430 | 9,703 | 32,798 | 31,742 |
Loss from operations | (12,430) | (9,490) | (32,563) | (31,293) |
Other income and expense: | ||||
Interest income | 103 | 39 | 323 | 70 |
Interest expense | (438) | (320) | (1,299) | (946) |
Total other income and expense | (335) | (281) | (976) | (876) |
Net loss | (12,765) | (9,771) | (33,539) | (32,169) |
Unrealized (loss) gain on available-for-sale securities | (9) | 10 | 15 | 24 |
Comprehensive loss | $ (12,774) | $ (9,761) | $ (33,524) | $ (32,145) |
Net loss per share attributable to common stockholders-basic and diluted (in dollars per share) | $ (0.45) | $ (0.37) | $ (1.18) | $ (1.38) |
Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted (in shares) | 28,370 | 26,610 | 28,267 | 23,228 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (12,765) | $ (9,771) | $ (33,539) | $ (32,169) |
Other comprehensive income (loss): | ||||
Comprehensive loss | $ (12,774) | $ (9,761) | $ (33,524) | $ (32,145) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating activities | ||
Net loss | $ (33,539) | $ (32,169) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 1,309 | 661 |
Stock-based compensation | 3,113 | 2,824 |
Net amortization of premium on investments | 0 | 25 |
Non-cash interest expense | 356 | 269 |
Changes in operating assets and liabilities | (1,342) | 17 |
Net cash used in operating activities | (30,103) | (28,373) |
Investing activities | ||
Purchases of property and equipment | (1,968) | (1,849) |
Proceeds from maturities of investments | 58,891 | 16,000 |
Purchases of investments | (18,755) | (58,698) |
Net cash provided by (used in) investing activities | 38,168 | (44,547) |
Financing activities | ||
Proceeds from equity offerings, net of issuance costs | 815 | 95,216 |
Proceeds from exercise of stock options | 166 | 354 |
Proceeds from the issuance of common stock under ESPP | 112 | 119 |
Net cash provided by financing activities | 1,093 | 95,689 |
Net increase in cash and cash equivalents | 9,158 | 22,769 |
Cash and cash equivalents at beginning of period | 17,259 | 20,058 |
Cash and cash equivalents at end of period | 26,417 | 42,827 |
Supplemental cash flow information | ||
Cash paid for interest | 943 | 661 |
Property and equipment included in accounts payable and accrued expenses | $ 293 | $ 531 |
Organization and operations
Organization and operations | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and operations | Organization and operations The Company Genocea Biosciences, Inc. (the “Company”) is a biopharmaceutical company that was incorporated in Delaware on August 16, 2006 and has a principal place of business in Cambridge, Massachusetts. The Company seeks to discover and develop novel vaccines and immunotherapies to address diseases with significant unmet needs. The Company’s development pipeline consists of candidates discovered using ATLAS TM , a proprietary discovery platform which enables the identification of clinically relevant T cell antigens for novel vaccines and immunotherapies targeting infectious disease and oncology applications. ATLAS is used to rapidly design vaccines and immunotherapies that act, in part, through T cell (or cellular) immune responses, in contrast to approved vaccines and immunotherapies, which are designed to act primarily through B cell (or antibody) immune responses. The Company believes that by harnessing T cells, first-in-class vaccines and immunotherapies can be developed to address diseases where T cells are central to the control of the disease. The Company has one product candidate in active Phase 2 clinical development, GEN-003, an immunotherapy for the treatment of genital herpes. The Company also has, in GEN-004, a Phase 2-ready universal vaccine for the prevention of pneumococcal infections. Although internal development of GEN-004 has been suspended, the Company is currently seeking partners to advance GEN-004 into a Phase 1/2 clinical trial targeting toddler and infant populations. In November 2016, the Company announced its intention to focus all near-term research and pre-clinical resources to accelerate its progress in immuno-oncology, specifically cancer vaccines. As a result of this decision, it has paused all work on early stage infectious disease programs in genital herpes, chlamydia, and malaria. Progress made and data generated to date in these infectious disease research programs remains valuable to Genocea for the future. The Company is devoting substantially all of its efforts to product research and development, initial market development, and raising capital. The Company has not generated any product revenue related to its primary business purpose to date and is subject to a number of risks similar to those of other clinical stage companies, including dependence on key individuals, competition from other companies, the need for and related uncertainty associated with the development of commercially viable products, and the need to obtain adequate additional financing to fund the development of its product candidates. The Company is also subject to a number of risks similar to other companies in the life sciences industry, including regulatory approval of products, uncertainty of market acceptance of products, competition from substitute products and larger companies, the need to obtain additional financing, compliance with government regulations, protection of proprietary technology, dependence on third parties, product liability, and dependence on key individuals. Liquidity As of September 30, 2016 , the Company had an accumulated deficit of approximately $191.4 million . The Company had cash, cash equivalents and investments of $75.5 million at September 30, 2016 . On the basis of current operating plans, including the plan to focus research investments on immuno-oncology and the planned commencement of Phase 3 trials for GEN-003 in the second half of 2017, it expects that these funds will be sufficient to fund operating expenses and capital expenditure requirements into the first quarter of 2018, without assuming any receipt of proceeds from potential business development partnerships, equity financings or debt drawdowns. At-the-market equity offering program On March 2, 2015, the Company entered into a Sales Agreement with Cowen and Company, LLC (the "Sales Agreement") to establish an at-the-market equity offering program (“ATM”) pursuant to which it was able to offer and sell up to $40 million of its Common Stock at prevailing market prices from time to time. On May 8, 2015, the Sales Agreement was amended to increase the offering amount under the ATM to $50 million of its Common Stock. In April 2016, the Company sold 136 thousand shares and received $0.8 million in net proceeds after deducting commissions. For the three months ended September 30, 2016 , there were no additional ATM sales. |
Summary of significant accounti
Summary of significant accounting policies | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Summary of significant accounting policies Basis of presentation and use of estimates The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the instructions of Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim condensed financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position as of September 30, 2016 and results of operations for the three and nine months ended September 30, 2016 and 2015 . The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full fiscal year. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2015 and the notes thereto which are included in the Company’s Annual Report on Form 10-K, as filed with the SEC on February 17, 2016. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, estimates related to prepaid and accrued research and development expenses, stock-based compensation expense and reported amounts of revenues and expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Cash, cash equivalents and investments The Company determines the appropriate classification of its investments at the time of purchase. All liquid investments with original maturities of three months or less from the purchase date are considered to be cash equivalents. The Company’s current and non-current investments are comprised of certificates of deposit and government agency securities that are classified as available-for-sale in accordance with ASC 320, Investments—Debt and Equity Securities. The Company classifies investments available to fund current operations as current assets on its balance sheets. Investments are classified as non-current assets on the balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year. Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in Accumulated other comprehensive income (loss) on the Company’s balance sheets. Realized gains and losses are determined using the specific identification method and are included as a component of Interest income or Interest expense, respectively. There were no realized gains or losses recognized for the nine months ended September 30, 2016 and 2015 . The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the investment before recovery of the investment’s amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, the severity and the duration of the impairment and changes in value subsequent to period end. As of September 30, 2016 , there were no investments with a fair value that was significantly lower than the amortized cost basis or any investments that had been in an unrealized loss position for a significant period. Fair value of financial instruments The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurement and Disclosures , established a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the financial instrument 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 financial instrument and are developed based on the best information available under the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported or disclosed fair value of the financial instruments and is not a measure of the investment credit quality. Fair value measurements are classified and disclosed in one of the following three categories: • Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. • Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly. • Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent that 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. Financial instruments measured at fair value on a recurring basis include cash equivalents and investments (Note 3). The Company is also required to disclose the fair value of financial instruments not carried at fair value. The fair value of the Company’s debt (Note 4) is determined using current applicable rates for similar instruments as of the balance sheet dates and an assessment of the credit rating of the Company. The carrying value of the Company’s debt approximates fair value because the Company’s interest rate yield is near current market rates for comparable debt instruments. The Company’s debt is considered a Level 3 liability within the fair value hierarchy. For the nine months ended September 30, 2016 , there were no transfers among Level 1, Level 2, or Level 3 categories. Additionally, there were no changes to the valuation methods utilized by the Company during the nine months ended September 30, 2016 . Recently adopted accounting standards Standard Description Effect on the financial statements ASU 2016-09, Compensation — Stock Compensation (Topic 718) In March 2016, the FASB issued ASU 2016-09, which provides for improvements to employee share-based payment accounting. The areas for simplification in this update involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016. The Company early adopted ASU 2016-09 as of June 30, 2016. In connection with the early adoption, the Company elected an accounting policy to record forfeitures as they occur. There was no financial statement impact upon adoption as the Company had estimated a forfeiture rate of zero given that most options awards vest on a monthly basis. ASU 2016-09 also provides that companies no longer record excess tax benefits or certain tax deficiencies in additional paid-in capital (APIC). Instead, all excess tax benefits and tax deficiencies are recorded as income tax expense or benefit in the income statement. There was no financial statement impact of adopting this provision of the ASU as the Company is in a net operating loss (NOL) position and all excess tax benefits that exist from options previously exercised require a full valuation allowance. As such, the adoption of this standard did not have a material impact on the financial statements. For the nine month period ending September 30, 2016, the Company did not record an income statement benefit for excess tax benefits as a valuation allowance is also required on these amounts. Recently issued accounting standards Standard Description Effect on the financial statements ASU 2014-09, Revenue from Contracts with Customers (Topic 606) The standard will replace existing revenue recognition standards and significantly expand the disclosure requirements for revenue arrangements. It may be adopted either retrospectively or on a modified retrospective basis to new contracts and existing contracts with remaining performance obligations as of the effective date. In July 2015, the FASB affirmed its proposal to defer the effective date of the new revenue standard for all entities by one year. As a result, public business entities will be required to apply the new revenue standard to annual reporting periods beginning after December 15, 2017. The standard will become effective for us on January 1, 2018 (the first quarter of our 2018 fiscal year). At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position as the Company does not currently have any arrangements that would be impacted by the new standard. As a result, the Company is continuing to evaluate the method of adoption and the impact of this standard on its consolidated financial statements. ASU 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40) In August 2014, the FASB issued ASU 2014-15, Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The standard requires an evaluation of whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. ASU 2014-15 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016. Management has evaluated ASU 2014-15 and believes it could have an impact on the Company’s financial statement disclosures in future reporting periods. Refer to the Liquidity section in Footnote 1 for further details regarding the Company’s liquidity. ASU 2016-02, Leases (Topic 842) In February 2016, the FASB issued ASU 2016-02, which replaces the existing lease accounting standards. The new standard requires a dual approach for lessee accounting under which a lessee would account for leases as finance (also referred to as capital) leases or operating leases. Both finance leases and operating leases will result in the lessee recognizing a right-of-use asset and corresponding lease liability. For finance leases the lessee would recognize interest expense and amortization of the right-of-use asset and for operating leases the lessee would recognize straight-line total lease expense. ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. The Company generally does not finance purchases of equipment but it does lease office and lab facilities. The Company is in the process of evaluating the effect that this ASU will have on its consolidated financial statements and related disclosures. |
Cash, cash equivalents and mark
Cash, cash equivalents and marketable securities | 9 Months Ended |
Sep. 30, 2016 | |
Cash and Cash Equivalents [Abstract] | |
Cash, cash equivalents and marketable securities | Cash, cash equivalents and investments As of September 30, 2016 and December 31, 2015 , cash, cash equivalents, and investments comprised funds in depository, money market accounts, U.S. treasuries, and FDIC insured certificates of deposit. The following table presents the cash equivalents and investments carried at fair value in accordance with the hierarchy defined in Note 2 (in thousands): Quoted prices in active markets Significant other observable inputs Significant unobservable inputs Total (Level 1) (Level 2) (Level 3) September 30, 2016 Money market funds, included in cash equivalents $ 24,460 $ 24,460 $ — $ — Investments - U.S treasuries 16,523 16,523 — — Investments - certificates of deposit 32,521 — 32,521 — Total $ 73,504 $ 40,983 $ 32,521 $ — December 31, 2015 Money market funds, included in cash equivalents $ 14,207 $ 14,207 $ — $ — U.S treasuries, included in cash equivalents 2,203 2,203 — — Investments - U.S. treasuries 27,924 27,924 — — Investments - certificates of deposit 61,249 — 61,249 — Total $ 105,583 $ 44,334 $ 61,249 $ — Cash equivalents and investments are valued using third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income-based and market-based approaches and observable market inputs to determine value. Investments at September 30, 2016 consist of the following (in thousands): Contracted Amortized Unrealized Unrealized Fair Value U.S. Treasuries 123-273 days $ 16,515 $ 8 $ — $ 16,523 Certificates of deposit 3-182 days 32,521 — — 32,521 Total $ 49,036 $ 8 $ — $ 49,044 |
Long-term debt
Long-term debt | 9 Months Ended |
Sep. 30, 2016 | |
Long-term Debt, Unclassified [Abstract] | |
Long-term debt | Long-term debt On November 20, 2014 (the "Closing Date"), the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Technology Growth Capital, Inc. (“Hercules”), which provided up to $27.0 million in debt financing in three separate tranches (the “2014 Term Loan”). The first tranche of $17.0 million was available through June 30, 2015, of which $12.0 million was drawn down at loan inception and for which approximately $9.8 million of the proceeds were used to repay all outstanding indebtedness under the previously existing $10.0 million loan agreement (the "2013 Term Loan"). The option to draw down the remaining $5.0 million under the first tranche expired unused on June 30, 2015. The second tranche of $5.0 million was subject to certain eligibility requirements which were achieved as of June 30, 2015 and the Company had the option to draw down the second tranche on or prior to December 15, 2015. The second tranche expired unused on December 15, 2015. The Company was not eligible to draw down the third tranche of $5.0 million because the Company did not achieve positive results in its Phase 2a human challenge study of GEN-004. In December 2015, the Company amended the Loan Agreement (the "First Amendment") with Hercules. The First Amendment required the Company to draw an additional $5.0 million and permits the Company to draw two additional $5.0 million tranches. One $5.0 million tranche is immediately available to draw through December 15, 2016 and a second $5.0 million tranche is available to draw through December 15, 2016, subject to the Company demonstrating sufficient evidence of continued clinical progression of its GEN-003 product candidate and making favorable progress in applying its proprietary technology platform toward the development of novel immunotherapies with application in oncology. As of September 30, 2016 , the second $5.0 million tranche is not yet available to the Company. At September 30, 2016 , $17.0 million was outstanding under the amended 2014 Term Loan. 2014 Term Loan The 2014 Term Loan had an original maturity of July 1, 2018. The eligibility requirements for the second tranche also contained an election for the Company to extend the maturity date to January 1, 2019. During the second quarter of 2015, the Company elected to extend the maturity date of the 2014 Term Loan. The maturity date of January 1, 2019 remained unchanged by the First Amendment. Each advance accrues interest at a floating rate per annum equal to the greater of (i) 7.25% or (ii) the sum of 7.25% plus the prime rate minus 5.0% . The 2014 Term Loan provided for interest-only payments until December 31, 2015, which was extended by the Company for a six -month period as the eligibility requirements for the second tranche were met during the second quarter of 2015. The First Amendment subsequently extended the interest-only period through June 30, 2017. Thereafter, beginning July 1, 2017, principal and interest payments will be made monthly for 18 months with a payoff schedule based upon a 30 -month amortization schedule, the original amortization term of the 2014 Term Loan. The remaining unpaid principal is due on January 1, 2019. The 2014 Term Loan may be prepaid in whole or in part upon seven business days’ prior written notice to Hercules. Prepayments will be subject to a charge of 3.0% if an advance is prepaid within 12 months following the Closing Date, 2.0% , if an advance is prepaid between 12 and 24 months following the Closing Date, and 1.0% thereafter. Amounts outstanding at the time of an event of default shall be payable on demand and shall accrue interest at an additional rate of 5.0% per annum on any outstanding amounts past due. The Company is also obligated to pay an end of term charge of 4.95% (the "End of Term Charge") of the balance drawn when the advances are repaid. The 2014 Term Loan is secured by a lien on substantially all of the assets of the Company, other than intellectual property, provided that such lien on substantially all assets includes any rights to payments and proceeds from the sale, licensing or disposition of intellectual property. The Loan Agreement contains non-financial covenants and representations, including a financial reporting covenant, and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries. There are no financial covenants. Under the provisions of the 2014 Term Loan, the Company has also entered into account control agreements ("ACAs") with Hercules and certain of the Company's financial institutions in which cash, cash equivalents, and investments are held. These ACAs grant Hercules a perfected first priority security interest in the subject accounts. The ACAs do not restrict the Company's ability to utilize cash, cash equivalents, or investments to fund operations and capital expenditures unless there is an event of default and Hercules activates its rights under the ACAs. The Loan Agreement contains a material adverse effect provision ("Material Adverse Effect") that requires all material adverse effects to be reported under the financial reporting covenant. Loan advances are subject to a representation that no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing. Under the Loan Agreement, a Material Adverse Effect means a material adverse effect upon: (i) the business, operations, properties, assets or condition (financial or otherwise) of the Company; or (ii) the ability of the Company to perform the secured obligations in accordance with the terms of the Loan Agreements, or the ability of agent or lender to enforce any of its rights or remedies with respect to the secured obligations; or (iii) the collateral or agent’s liens on the collateral or the priority of such liens. Any event that has or would reasonably be expected to have a Material Adverse Effect is an event of default under the Loan Agreement and repayment of amounts due under the Loan Agreement may be accelerated by Hercules under the same terms as an event of default. Events of default under the Loan Agreement include failure to make any payments of principal or interest as due on any outstanding indebtedness, breach of any covenant, any false or misleading representations or warranties, insolvency or bankruptcy, any attachment or judgment on the Company’s assets of at least $100 thousand, or the occurrence of any material default of the Company involving indebtedness in excess of $100 thousand. If an event of default occurs, repayment of all amounts due under the Loan Agreement may be accelerated by Hercules, including the applicable prepayment charge. In connection with the 2014 Term Loan, the Company issued a common stock warrant to Hercules on November 20, 2014. The warrant is exercisable for 73,725 shares of the Company’s Common Stock (equal to $607,500 divided by the exercise price of $8.24 per share). The exercise price and the number of shares are subject to adjustment upon a merger event, reclassification of the shares of Common Stock, subdivision or combination of the shares of Common Stock or certain dividends payments. The warrant is exercisable until November 20, 2019 and will be exercised automatically on a net issuance basis if not exercised prior to the expiration date and if the then-current fair market value of one share of Common Stock is greater than the exercise price then in effect. The warrant has been classified as equity for all periods it has been outstanding. Contemporaneously with the 2014 Term Loan, the Company also entered into an equity rights letter agreement on November 20, 2014 (the “Equity Rights Letter Agreement”). Pursuant to the Equity Rights Letter Agreement, the Company issued to Hercules 223,463 shares of the Company’s Common Stock for an aggregate purchase price of approximately $2.0 million at a price per share equal to the closing price of the Company’s Common Stock as reported on The NASDAQ Global Market on November 19, 2014. The shares will be subject to resale limitations and may be resold only pursuant to an effective registration statement or an exemption from registration. Additionally, under the Equity Rights Letter Agreement, Hercules has the right to participate in any one or more subsequent private placement equity financings of up to $2.0 million on the same terms and conditions as purchases by the other investors in each subsequent equity financing. The Equity Rights Letter Agreement, and all rights and obligations thereunder, will terminate upon the earlier of (1) such time when Hercules has purchased $2.0 million of subsequent equity financing securities in the aggregate and (2) the later of (a) the repayment of all indebtedness under the Loan Agreement and (b) the expiration or termination of the exercise period for the warrant issued in connection with the Loan Agreement. The Company allocated $36 thousand of financing costs to additional paid-in capital for issuance fees that were reimbursed to Hercules. The Company incurred $280 thousand in debt financing costs related to the First Amendment, which was recorded as a debt discount and will be amortized over the remaining loan term. In connection with the issuance of the 2014 Term Loan, the Company incurred $103 thousand of financing costs and also reimbursed Hercules $210 thousand for debt financing costs, which has been recorded as a debt discount and will be amortized over the remaining loan term. The End of Term Charge is amortized ratably over the term loan period based upon the outstanding debt amount. The increase in the End of Term Charge due to the additional borrowing from the First Amendment is being amortized from the First Amendment date through maturity. The debt discount is being amortized to interest expense over the life of the 2014 Term Loan using the effective interest method. At September 30, 2016 , the 2014 Term Loan bears an effective interest rate of 10.2% . As of both September 30, 2016 and December 31, 2015, the Company had outstanding borrowings under the 2014 Term Loan of $17.0 million . Interest expense related to the 2014 Term Loan was $0.4 million and $1.3 million for the three and nine months ended September 30, 2016 , respectively, and $0.3 million and $0.9 million for the three and nine months ended September 30, 2015 , respectively. Future principal payments, including the End of Term Charge, on the 2014 Term Loan are as follows (in thousands): September 30, 2016 $ — 2017 3,149 2018 6,659 2019 8,034 Total $ 17,842 |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies Lease commitments In May 2016, the Company entered into a lease amendment (the "2016 Lease") for office and laboratory space currently occupied under an original lease that commenced in March 2014 and was set to expire in February 2017 (the "2014 Lease"). The 2016 Lease extends the 2014 Lease by an additional three years through February 2020. In June 2015, the Company signed a second operating lease (the "2015 Lease") for office space in the same building as the 2014 Lease. In August 2016, the Company exercised a three -year renewal option extending the 2015 Lease to February 2020. The minimum future lease payments under both the 2016 Lease and the 2015 Lease are as follows (in thousands): September 30, 2016 2016 $ 316 2017 1,550 2018 1,607 2019 1,637 2020 274 Total $ 5,384 At September 30, 2016 and December 31, 2015 , the Company has an outstanding letter of credit of $316 thousand with a financial institution related to a security deposit for the 2016 Lease, which is secured by cash on deposit and expires on February 29, 2020. An additional unsecured deposit was required for the 2015 Lease. Significant Contracts and Agreements In addition to lease commitments, the Company enters into contractual arrangements that obligate it to make payments to the contractual counterparties upon the occurrence of future events. In the normal course of operations, the Company enters into license and other agreements and intends to continue to seek additional rights related to compounds or technologies in connection with its discovery, manufacturing and development programs. These agreements may require payments to be made by the Company upon the occurrence of certain development milestones and certain commercialization milestones for each distinct product covered by the licensed patents (in addition to certain royalties to be paid on marketed products or sublicense income) contingent upon the occurrence of future events that cannot be reasonably estimated. In March 2014, the Company announced a joint research collaboration with Dana-Farber Cancer Institute to characterize anti-tumor T cell responses in melanoma patients. This collaboration extends the use of the Company's proprietary ATLAS platform for the rapid discovery of T cell antigens to cancer immunotherapy approaches. In September 2014, the Company received $1.2 million in the form of a grant entered into with the Bill & Melinda Gates Foundation for the identification of protective T-cell antigens for malaria vaccines. This grant provided for the continued expansion of the Company’s malaria antigen library to aid in the identification of novel protein antigens to facilitate the development of highly efficacious anti-infection malarial vaccines. The Company recognized revenue under these agreements of $213 thousand and $449 thousand for the three and nine months ended September 30, 2015, respectively. The Company recognized revenue of no ne and $235 thousand for the three and nine months ended September 30, 2016 , respectively. The Company relies on research institutions, contract research organizations, clinical investigators as well as clinical and commercial material manufacturers of our product candidates. Under the terms of these agreements, the Company is obligated to make milestone payments upon the achievement of manufacturing or clinical milestones defined in the contracts. In some cases, monthly service fees for project management services are charged over the duration of the arrangement. In addition, clinical and manufacturing contracts generally require reimbursement to suppliers for certain set-up, production, travel, and other related costs as they are incurred. In some manufacturing contracts, the Company also may be responsible for the payment of a reservation fee, which will equal a percentage of the expected production fees, to reserve manufacturing slots in the production timeframe. Generally, the Company is liable for actual effort expended by these organizations at any point in time during the contract through the notice period. To the extent amounts paid to a supplier exceed the milestones achieved, the Company records a prepaid asset, and to the extent milestones achieved exceed amounts billed or billable under a contract, an accrual for the estimate of services rendered is recorded. In February 2014, the Company entered into a supply agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (“Fujifilm”) for the manufacture and supply of antigens for future GEN-003 clinical trials. Under the agreement, the Company is obligated to pay Fujifilm manufacturing milestones, in addition to reimbursement of certain material production related costs. In June and September 2016, the Company entered into new statements of work under the agreement with Fujifilm for the manufacture and supply of antigens for the Company's Phase 3 clinical trials. The Company incurred expenses under the agreement of $0.4 million and $3.9 million for the three and nine months ended September 30, 2015, respectively. The Company incurred expenses under the agreement of $0.5 million and $0.8 million for the three and nine months ended September 30, 2016 , respectively. Litigation The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities. Refund of research and development expense In August 2009, the Company entered into an exclusive license and collaboration agreement (the “Novavax Agreement”) with Isconova AB, a Swedish company which subsequently was acquired by Novavax, Inc. ("Novavax"). Pursuant to the agreement, Novavax granted the Company a worldwide, sublicensable, exclusive license to two patent families, to import, make, have made, use, sell, offer for sale and otherwise exploit licensed vaccine products containing an adjuvant which incorporates or is developed from Matrix-A, Matrix-C and/or Matrix-M technology, in the fields of HSV and chlamydia. Matrix-M is the adjuvant used in GEN-003. The Novavax Agreement includes a research funding clause for which the Company made monthly payments to Novavax between August 2009 and March 2012 of approximately $1.6 million . All amounts of research funding provided were to be refunded by Novavax. After December 31, 2015, any amounts remaining due from Novavax, including accrued interest, could be received in cash upon 30 -day written notice provided by the Company. The Company provided this notice in January 2016. The Company provided the research funding solely to benefit the supply plan for the Matrix-M adjuvant to the point that a Phase 1 clinical trial could be initiated. Because of the benefit received from the research funding payments, an assessment of Novavax's financial ability to repay the research funding at the time of the payments, along with the duration of which amounts could be outstanding, the Company concluded the initial research funding should be recorded as research and development expense at the time of payment. In February 2016, upon receipt of the $1.6 million refund including accrued interest, the Company recorded a gain within operating expenses on the Condensed Consolidated Statements of Operations and Comprehensive Loss. |
Equity and net loss per share
Equity and net loss per share | 9 Months Ended |
Sep. 30, 2016 | |
Common Stock, Number of Shares, Par Value and Other Disclosures [Abstract] | |
Equity and net loss per share | Equity and net loss per share At September 30, 2016 , the Company has authorized 25,000,000 shares of preferred stock at $0.001 par value per share. As of September 30, 2016 and December 31, 2015 , there were no shares of preferred stock issued or outstanding. At September 30, 2016 , the Company has authorized 175,000,000 shares of Common Stock at $0.001 par value per share. As of September 30, 2016 and December 31, 2015 , there were 28,384,548 and 28,161,313 shares, respectively, of Common Stock issued. As of September 30, 2016 and December 31, 2015 , there were 28,380,663 and 28,151,596 shares, respectively, of Common Stock outstanding. The Company computes basic and diluted earnings (loss) per share using a methodology that gives effect to the impact of outstanding participating securities (the “two-class method”). As the three and nine months ended for both September 30, 2016 and 2015 resulted in net losses, there is no income allocation required under the two-class method or dilution attributed to weighted average shares outstanding in the calculation of diluted loss per share. As of September 30, 2016 and December 31, 2015 , the Company had warrants outstanding that represent the right to acquire 77,603 shares of Common Stock, of which 73,725 represented warrants issued to Hercules and 3,878 represented warrants to purchase Common Stock issued in periods prior to the Company's initial public offering ("IPO"). The following common stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for the periods presented, due to their anti-dilutive effect (in thousands): Nine Months Ended September 30, 2016 2015 Warrants 78 78 Outstanding options 3,794 2,716 Outstanding ESPP 21 13 Total 3,893 2,807 Restricted stock During 2013, a Company director exercised stock options and received 31,092 shares of Common Stock that were subject to a Stock Restriction and Repurchase Agreement with the Company. Under the terms of the agreement, shares of Common Stock issued are subject to a vesting schedule and unvested shares are subject to repurchase by the Company. Vesting occurs periodically at specified time intervals and specified percentages. All shares of Common Stock become fully vested within four years of the date of grant. As of both September 30, 2016 and December 31, 2015 , the Company had issued 35,964 shares of restricted Common Stock. The Company had 3,885 and 9,717 shares of nonvested restricted stock that were subject to repurchase by the Company as of September 30, 2016 and December 31, 2015 , respectively. |
Stock and employee benefit plan
Stock and employee benefit plans | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock and employee benefit plans | Stock and employee benefit plans Stock-based compensation expense Total stock-based compensation expense is recognized for stock options granted to employees and non-employees and has been reported in the Company’s statements of operations as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 428 $ 380 $ 1,234 $ 1,245 General and administrative 691 498 1,879 1,579 Total $ 1,119 $ 878 $ 3,113 $ 2,824 Stock options The following table summarizes stock option activity for employees and nonemployees (shares in thousands): Shares Weighted- Weighted- Aggregate Outstanding at December 31, 2015 2,723 $ 7.60 7.61 $ 2,840 Granted 1,472 $ 3.51 Exercised (56 ) $ 2.96 Canceled (345 ) $ 8.46 Outstanding at September 30, 2016 3,794 $ 6.01 7.74 $ 4,708 Exercisable at September 30, 2016 1,763 $ 6.09 6.47 $ 2,627 Vested or expected to vest at September 30, 2016 3,794 $ 6.01 7.74 $ 4,708 Performance-based stock options The Company granted stock options to certain employees, executive officers and consultants, which contain performance-based vesting criteria. Milestone events are specific to the Company’s corporate goals, which include, but are not limited to, certain clinical development milestones, business development agreements and capital fundraising events. Stock-based compensation expense associated with these performance-based stock options is recognized if the performance conditions are considered probable of being achieved, using management’s best estimates. The Company determined that none of the performance-based milestones were probable of achievement during the three and nine months ended September 30, 2016 , and accordingly did not recognize stock-based compensation expense for these periods. As of September 30, 2016 , there are 56,336 performance-based common stock options outstanding for which the probability of achievement was not deemed probable. Employee stock purchase plan In connection with the completion of the Company's IPO on February 10, 2014, the Company’s Board of Directors adopted the 2014 Employee Stock Purchase Plan (the “2014 ESPP”). The 2014 ESPP authorizes the initial issuance of up to a total of 200,776 shares of Common Stock to participating eligible employees. The 2014 ESPP provides for six -month option periods commencing on January 1 and ending June 30 and commencing July 1 and ending December 31 of each calendar year. As of September 30, 2016 , 112,073 shares remain for future issuance under the plan. The Company incurred stock-based compensation expense related to the 2014 ESPP of $45 thousand and $110 thousand for the three and nine months ended September 30, 2016 , respectively, and $30 thousand and $83 thousand for the three and nine months ended September 30, 2015 , respectively. |
Summary of significant accoun13
Summary of significant accounting policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation and use of estimates The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the instructions of Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim condensed financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position as of September 30, 2016 and results of operations for the three and nine months ended September 30, 2016 and 2015 . The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full fiscal year. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2015 and the notes thereto which are included in the Company’s Annual Report on Form 10-K, as filed with the SEC on February 17, 2016. |
Use of estimates | The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, estimates related to prepaid and accrued research and development expenses, stock-based compensation expense and reported amounts of revenues and expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Cash, cash equivalents and investments | Cash, cash equivalents and investments The Company determines the appropriate classification of its investments at the time of purchase. All liquid investments with original maturities of three months or less from the purchase date are considered to be cash equivalents. The Company’s current and non-current investments are comprised of certificates of deposit and government agency securities that are classified as available-for-sale in accordance with ASC 320, Investments—Debt and Equity Securities. The Company classifies investments available to fund current operations as current assets on its balance sheets. Investments are classified as non-current assets on the balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year. Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in Accumulated other comprehensive income (loss) on the Company’s balance sheets. Realized gains and losses are determined using the specific identification method and are included as a component of Interest income or Interest expense, respectively. There were no realized gains or losses recognized for the nine months ended September 30, 2016 and 2015 . The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the investment before recovery of the investment’s amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, the severity and the duration of the impairment and changes in value subsequent to period end. As of September 30, 2016 , there were no investments with a fair value that was significantly lower than the amortized cost basis or any investments that had been in an unrealized loss position for a significant period. |
Fair value of financial instruments | Fair value of financial instruments The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurement and Disclosures , established a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the financial instrument 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 financial instrument and are developed based on the best information available under the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported or disclosed fair value of the financial instruments and is not a measure of the investment credit quality. Fair value measurements are classified and disclosed in one of the following three categories: • Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. • Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly. • Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent that 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. Financial instruments measured at fair value on a recurring basis include cash equivalents and investments (Note 3). The Company is also required to disclose the fair value of financial instruments not carried at fair value. The fair value of the Company’s debt (Note 4) is determined using current applicable rates for similar instruments as of the balance sheet dates and an assessment of the credit rating of the Company. The carrying value of the Company’s debt approximates fair value because the Company’s interest rate yield is near current market rates for comparable debt instruments. The Company’s debt is considered a Level 3 liability within the fair value hierarchy. |
Recently issued accounting standards | Recently issued accounting standards Standard Description Effect on the financial statements ASU 2014-09, Revenue from Contracts with Customers (Topic 606) The standard will replace existing revenue recognition standards and significantly expand the disclosure requirements for revenue arrangements. It may be adopted either retrospectively or on a modified retrospective basis to new contracts and existing contracts with remaining performance obligations as of the effective date. In July 2015, the FASB affirmed its proposal to defer the effective date of the new revenue standard for all entities by one year. As a result, public business entities will be required to apply the new revenue standard to annual reporting periods beginning after December 15, 2017. The standard will become effective for us on January 1, 2018 (the first quarter of our 2018 fiscal year). At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position as the Company does not currently have any arrangements that would be impacted by the new standard. As a result, the Company is continuing to evaluate the method of adoption and the impact of this standard on its consolidated financial statements. ASU 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40) In August 2014, the FASB issued ASU 2014-15, Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The standard requires an evaluation of whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. ASU 2014-15 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016. Management has evaluated ASU 2014-15 and believes it could have an impact on the Company’s financial statement disclosures in future reporting periods. Refer to the Liquidity section in Footnote 1 for further details regarding the Company’s liquidity. ASU 2016-02, Leases (Topic 842) In February 2016, the FASB issued ASU 2016-02, which replaces the existing lease accounting standards. The new standard requires a dual approach for lessee accounting under which a lessee would account for leases as finance (also referred to as capital) leases or operating leases. Both finance leases and operating leases will result in the lessee recognizing a right-of-use asset and corresponding lease liability. For finance leases the lessee would recognize interest expense and amortization of the right-of-use asset and for operating leases the lessee would recognize straight-line total lease expense. ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. The Company generally does not finance purchases of equipment but it does lease office and lab facilities. The Company is in the process of evaluating the effect that this ASU will have on its consolidated financial statements and related disclosures. |
Summary of significant accoun14
Summary of significant accounting policies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Schedule of recent accounting pronouncements | Standard Description Effect on the financial statements ASU 2014-09, Revenue from Contracts with Customers (Topic 606) The standard will replace existing revenue recognition standards and significantly expand the disclosure requirements for revenue arrangements. It may be adopted either retrospectively or on a modified retrospective basis to new contracts and existing contracts with remaining performance obligations as of the effective date. In July 2015, the FASB affirmed its proposal to defer the effective date of the new revenue standard for all entities by one year. As a result, public business entities will be required to apply the new revenue standard to annual reporting periods beginning after December 15, 2017. The standard will become effective for us on January 1, 2018 (the first quarter of our 2018 fiscal year). At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position as the Company does not currently have any arrangements that would be impacted by the new standard. As a result, the Company is continuing to evaluate the method of adoption and the impact of this standard on its consolidated financial statements. ASU 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40) In August 2014, the FASB issued ASU 2014-15, Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The standard requires an evaluation of whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. ASU 2014-15 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016. Management has evaluated ASU 2014-15 and believes it could have an impact on the Company’s financial statement disclosures in future reporting periods. Refer to the Liquidity section in Footnote 1 for further details regarding the Company’s liquidity. ASU 2016-02, Leases (Topic 842) In February 2016, the FASB issued ASU 2016-02, which replaces the existing lease accounting standards. The new standard requires a dual approach for lessee accounting under which a lessee would account for leases as finance (also referred to as capital) leases or operating leases. Both finance leases and operating leases will result in the lessee recognizing a right-of-use asset and corresponding lease liability. For finance leases the lessee would recognize interest expense and amortization of the right-of-use asset and for operating leases the lessee would recognize straight-line total lease expense. ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. The Company generally does not finance purchases of equipment but it does lease office and lab facilities. The Company is in the process of evaluating the effect that this ASU will have on its consolidated financial statements and related disclosures. |
Cash, cash equivalents and ma15
Cash, cash equivalents and marketable securities (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of cash, cash equivalents and marketable securities carried at fair value | The following table presents the cash equivalents and investments carried at fair value in accordance with the hierarchy defined in Note 2 (in thousands): Quoted prices in active markets Significant other observable inputs Significant unobservable inputs Total (Level 1) (Level 2) (Level 3) September 30, 2016 Money market funds, included in cash equivalents $ 24,460 $ 24,460 $ — $ — Investments - U.S treasuries 16,523 16,523 — — Investments - certificates of deposit 32,521 — 32,521 — Total $ 73,504 $ 40,983 $ 32,521 $ — December 31, 2015 Money market funds, included in cash equivalents $ 14,207 $ 14,207 $ — $ — U.S treasuries, included in cash equivalents 2,203 2,203 — — Investments - U.S. treasuries 27,924 27,924 — — Investments - certificates of deposit 61,249 — 61,249 — Total $ 105,583 $ 44,334 $ 61,249 $ — |
Schedule of marketable securities | Investments at September 30, 2016 consist of the following (in thousands): Contracted Amortized Unrealized Unrealized Fair Value U.S. Treasuries 123-273 days $ 16,515 $ 8 $ — $ 16,523 Certificates of deposit 3-182 days 32,521 — — 32,521 Total $ 49,036 $ 8 $ — $ 49,044 |
Long-term debt (Tables)
Long-term debt (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Long-term Debt, Unclassified [Abstract] | |
Schedule of future principal payments on the new term loan | Future principal payments, including the End of Term Charge, on the 2014 Term Loan are as follows (in thousands): September 30, 2016 $ — 2017 3,149 2018 6,659 2019 8,034 Total $ 17,842 |
Commitments and contingencies (
Commitments and contingencies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease payments for operating leases | The minimum future lease payments under both the 2016 Lease and the 2015 Lease are as follows (in thousands): September 30, 2016 2016 $ 316 2017 1,550 2018 1,607 2019 1,637 2020 274 Total $ 5,384 |
Common stock (Tables)
Common stock (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Common Stock, Number of Shares, Par Value and Other Disclosures [Abstract] | |
Schedule of common stock equivalents, presented on converted basis, were excluded from calculation of net loss per share due to anti-dilutive effect | The following common stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for the periods presented, due to their anti-dilutive effect (in thousands): Nine Months Ended September 30, 2016 2015 Warrants 78 78 Outstanding options 3,794 2,716 Outstanding ESPP 21 13 Total 3,893 2,807 |
Stock and employee benefit pl19
Stock and employee benefit plans (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of stock-based compensation expense for stock options granted to employees and non-employees | Total stock-based compensation expense is recognized for stock options granted to employees and non-employees and has been reported in the Company’s statements of operations as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 428 $ 380 $ 1,234 $ 1,245 General and administrative 691 498 1,879 1,579 Total $ 1,119 $ 878 $ 3,113 $ 2,824 |
Schedule of stock option activity for employees and nonemployees | The following table summarizes stock option activity for employees and nonemployees (shares in thousands): Shares Weighted- Weighted- Aggregate Outstanding at December 31, 2015 2,723 $ 7.60 7.61 $ 2,840 Granted 1,472 $ 3.51 Exercised (56 ) $ 2.96 Canceled (345 ) $ 8.46 Outstanding at September 30, 2016 3,794 $ 6.01 7.74 $ 4,708 Exercisable at September 30, 2016 1,763 $ 6.09 6.47 $ 2,627 Vested or expected to vest at September 30, 2016 3,794 $ 6.01 7.74 $ 4,708 |
Organization and operations (De
Organization and operations (Details) | 9 Months Ended |
Sep. 30, 2016product | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of products in clinical development | 1 |
Organization and operations (21
Organization and operations (Details 2) - USD ($) shares in Thousands | 1 Months Ended | 9 Months Ended | ||||
Apr. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | May 08, 2015 | Mar. 02, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Accumulated deficit | $ (191,449,000) | $ (157,910,000) | ||||
Cash equivalents and investments | 75,500,000 | |||||
At-the-market equity offering program, maximum value of common stock to offer and sale | 0 | $ 50,000,000 | $ 40,000,000 | |||
Common stock, shares issued (in shares) | 136 | |||||
Proceeds from sale of common stock, net of issuance costs | $ 800,000 | $ 815,000 | $ 95,216,000 |
Cash, cash equivalents and ma22
Cash, cash equivalents and marketable securities (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Quoted prices in active markets (Level 1) | ||
Cash, cash equivalents and marketable securities | ||
Beginning Balance | $ 24,460 | $ 14,207 |
Investments - certificates of deposit | 0 | 0 |
Total | 40,983 | 44,334 |
Fair Value, Inputs, Level 2 | ||
Cash, cash equivalents and marketable securities | ||
Beginning Balance | 0 | |
Investments - certificates of deposit | 32,521 | 61,249 |
Total | 32,521 | 61,249 |
U.S. Treasuries | Quoted prices in active markets (Level 1) | ||
Cash, cash equivalents and marketable securities | ||
Certificates of deposit, included in cash equivalents | 16,523 | 27,924 |
Total | 2,203 | |
Total | ||
Cash, cash equivalents and marketable securities | ||
Beginning Balance | 24,460 | 14,207 |
Investments - certificates of deposit | 32,521 | 61,249 |
Total | 73,504 | 105,583 |
Total | U.S. Treasuries | ||
Cash, cash equivalents and marketable securities | ||
Certificates of deposit, included in cash equivalents | $ 16,523 | 27,924 |
Total | $ 2,203 |
Cash, cash equivalents and ma23
Cash, cash equivalents and marketable securities (Details 2) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2015 | |
Marketable securities | ||
Amortized Cost, Total | $ 49,036 | |
Unrealized Gains, Total | 8 | |
Fair Value, Total | 49,044 | $ 77,069 |
U.S. Treasuries | ||
Marketable securities | ||
Amortized Cost, Total | 16,515 | |
Unrealized Gains, Total | 8 | |
Fair Value, Total | $ 16,523 | |
U.S. Treasuries | Minimum | ||
Marketable securities | ||
Contracted Maturity | 123 days | |
U.S. Treasuries | Maximum | ||
Marketable securities | ||
Contracted Maturity | 273 days | |
Certificates of deposit | ||
Marketable securities | ||
Amortized Cost, Total | $ 32,521 | |
Unrealized Gains, Total | 0 | |
Fair Value, Total | $ 32,521 | |
Certificates of deposit | Minimum | ||
Marketable securities | ||
Contracted Maturity | 3 days | |
Certificates of deposit | Maximum | ||
Marketable securities | ||
Contracted Maturity | 182 days |
Long-term debt (Details)
Long-term debt (Details) | Nov. 20, 2014USD ($)tranche$ / sharesshares | Sep. 30, 2016USD ($)shares | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)shares | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($)tranche |
Common stock | ||||||
Long-Term Debt | ||||||
Exercisable amount (in shares) | shares | 77,603 | 77,603 | ||||
Line of Credit | 2013 Term Loan | ||||||
Long-Term Debt | ||||||
Debt financing | $ 10,000,000 | |||||
Repay indebtedness | 9,800,000 | |||||
Line of Credit | 2014 Term Loan | ||||||
Long-Term Debt | ||||||
Debt financing | $ 27,000,000 | |||||
Tranches, number | tranche | 3 | |||||
Interest rate (as a percent) | 7.25% | |||||
Extension term (in months) | 6 months | |||||
Debt instrument, term | 18 months | |||||
Number of monthly payments of principal and accrued interest | 30 months | |||||
Prepayment, written notice period | 7 months | |||||
Prepayment charge, first twelve months (as a percent) | 3.00% | |||||
Prepayment charge, between twelve months and twenty four months (as a percent) | 2.00% | |||||
Prepayment charge, after twenty four months (as a percent) | 1.00% | |||||
Additional interest rate (as a percent) | 5.00% | |||||
End of term charge (as a percent) | 4.95% | |||||
Attachment or judgment on the Company's assets causing an event of default, minimum | $ 100 | |||||
Financing costs | $ 280,000 | $ 280,000 | ||||
Debt discount | 210,000 | |||||
Effective interest rate | 10.20% | 10.20% | ||||
Outstanding borrowings | $ 17,000,000 | $ 17,000,000 | $ 17,000,000 | |||
Interest expense | 400,000 | $ 300,000 | 1,300,000 | $ 900,000 | ||
Line of Credit | 2014 Term Loan | Other current assets | ||||||
Long-Term Debt | ||||||
Financing costs | $ 103,000 | |||||
Line of Credit | 2014 Term Loan | Prime rate | ||||||
Long-Term Debt | ||||||
Spread on variable rate basis (as a percent) | 5.00% | |||||
Line of Credit | 2014 Term Loan, First Tranche | ||||||
Long-Term Debt | ||||||
Debt financing | $ 17,000,000 | |||||
Draw downs | $ 12,000,000 | 17,000,000 | 17,000,000 | |||
Expired borrowing capacity | 5,000,000 | 5,000,000 | ||||
Line of Credit | Term Loan 2014, First Amendment | ||||||
Long-Term Debt | ||||||
Debt financing | $ 5,000,000 | |||||
Tranches, number | tranche | 2 | |||||
Line of Credit | Term Loan 2014, First Amendment, Tranche 1 | ||||||
Long-Term Debt | ||||||
Debt financing | $ 5,000,000 | |||||
Line of Credit | Term Loan 2014, First Amendment, Tranche 2 | ||||||
Long-Term Debt | ||||||
Debt financing | 5,000,000 | 5,000,000 | $ 5,000,000 | |||
Expired borrowing capacity | 5,000,000 | 5,000,000 | ||||
Line of Credit | Term Loan 2014, First Amendment, Tranche 3 | ||||||
Long-Term Debt | ||||||
Expired borrowing capacity | $ 5,000,000 | $ 5,000,000 | ||||
Hercules Technology Growth Capital, Inc. | Common stock | ||||||
Long-Term Debt | ||||||
Exercisable amount (in shares) | shares | 73,725 | 73,725 | 73,725 | |||
Warrant, exercisable, value | $ 607,500 | |||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 8.24 | |||||
Private Placement | Hercules Technology Growth Capital, Inc. | ||||||
Long-Term Debt | ||||||
Issuance of common stock (in shares) | shares | 223,463 | |||||
Issuance of common stock | $ 2,000,000 | |||||
Financing costs allocated to additional paid-in capital | $ 36,000 | |||||
Debt Instrument, Redemption, Period One | Line of Credit | 2014 Term Loan | ||||||
Long-Term Debt | ||||||
Prepayment period | 12 months | |||||
Minimum | Debt Instrument, Redemption, Period Two | Line of Credit | 2014 Term Loan | ||||||
Long-Term Debt | ||||||
Prepayment period | 12 months | |||||
Maximum | Debt Instrument, Redemption, Period Two | Line of Credit | 2014 Term Loan | ||||||
Long-Term Debt | ||||||
Prepayment period | 24 months |
Long-term debt (Details 2)
Long-term debt (Details 2) - 2014 Term Loan - Line of Credit | Sep. 30, 2016USD ($) |
Future principal payments | |
2,016 | $ 0 |
2,017 | 3,149,000 |
2,018 | 6,659,000 |
2,019 | 8,034,000 |
Total | $ 17,842,000 |
Commitments and contingencies26
Commitments and contingencies (Details) - USD ($) $ in Thousands | 1 Months Ended | |||
May 31, 2016 | Jun. 30, 2015 | Sep. 30, 2016 | Dec. 31, 2015 | |
Restricted cash related to facilities leases | ||||
Renewal period (in years) | 3 years | 3 years | ||
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||||
2,016 | $ 316 | |||
2,017 | 1,550 | |||
2,018 | 1,607 | |||
2,019 | 1,637 | |||
2,020 | 274 | |||
Total | 5,384 | |||
2012 Master Facilities Lease | ||||
Restricted cash related to facilities leases | ||||
Restricted cash | $ 316 | $ 316 |
Commitments and contingencies27
Commitments and contingencies (Details 2) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Commitments and contingencies | |||||
Grant revenue | $ 0 | $ 213,000 | $ 235,000 | $ 449,000 | |
Bill and Melinda Gates Foundation | |||||
Commitments and contingencies | |||||
Grant received | $ 1,200,000 | ||||
Grant revenue | $ 0 | $ 213,000 | $ 235,000 | $ 449,000 |
Commitments and contingencies28
Commitments and contingencies (Details 3) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)product | Sep. 30, 2015USD ($) | |
Commitments and contingencies | ||||
Amount expensed related to supply agreements | $ 8,811 | $ 6,058 | $ 22,821 | $ 21,536 |
Number of patent families | product | 2 | |||
Number of days from written notice | 30 days | |||
Supply agreement | Fujifilm | ||||
Commitments and contingencies | ||||
Amount expensed related to supply agreements | $ 500 | $ 400 | $ 800 | $ 3,900 |
Commitments and contingencies R
Commitments and contingencies Refund (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 32 Months Ended | ||
Feb. 29, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Mar. 31, 2012 | |
Commitments and Contingencies Disclosure [Abstract] | ||||||
Research and Development Expense, Refund | $ (1,600) | $ 0 | $ 0 | $ 1,592 | $ 0 | $ (1,600) |
Common stock (Details)
Common stock (Details) - $ / shares | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2013 | Nov. 20, 2014 | |
Common stock | |||||
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Preferred stock, shares issued (in shares) | 0 | 0 | |||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||
Common stock, shares authorized (in shares) | 175,000,000 | 175,000,000 | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Common stock, shares issued (in shares) | 28,384,548 | 28,161,313 | |||
Common stock, shares outstanding (in shares) | 28,380,663 | 28,151,596 | |||
Earnings Per Share, Diluted [Abstract] | |||||
Common stock equivalents (in shares) | 3,893,000 | 2,807,000 | |||
Outstanding options | |||||
Common stock | |||||
Options exercised (in shares) | 56,000 | ||||
Restricted common stock | |||||
Common stock | |||||
Vesting period (in years) | 4 years | ||||
Number of shares issued (in shares) | 35,964 | 35,964 | |||
Number of shares subject to repurchase by entity (in shares) | 3,885 | 9,717 | |||
Director | Outstanding options | |||||
Common stock | |||||
Options exercised (in shares) | 31,092 | ||||
Warrants | |||||
Earnings Per Share, Diluted [Abstract] | |||||
Common stock equivalents (in shares) | 78,000 | 78,000 | |||
Outstanding options | |||||
Earnings Per Share, Diluted [Abstract] | |||||
Common stock equivalents (in shares) | 3,794,000 | 2,716,000 | |||
2014 ESPP | |||||
Earnings Per Share, Diluted [Abstract] | |||||
Common stock equivalents (in shares) | 21,000 | 13,000 | |||
Common stock | |||||
Common stock | |||||
Exercisable amount (in shares) | 77,603 | ||||
Warrants to purchase redeemable convertible preferred stock automatically converted to warrants to purchase common stock | |||||
Common stock | |||||
Exercisable amount (in shares) | 3,878 | ||||
Hercules Technology Growth Capital, Inc. | Common stock | |||||
Common stock | |||||
Exercisable amount (in shares) | 73,725 | 73,725 |
Stock and employee benefit pl31
Stock and employee benefit plans (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stock Based Compensation Expense | ||||
Stock-based compensation expense | $ 1,119 | $ 878 | $ 3,113 | $ 2,824 |
Research and development | ||||
Stock Based Compensation Expense | ||||
Stock-based compensation expense | 428 | 380 | 1,234 | 1,245 |
General and administrative | ||||
Stock Based Compensation Expense | ||||
Stock-based compensation expense | $ 691 | $ 498 | $ 1,879 | $ 1,579 |
Stock and employee benefit pl32
Stock and employee benefit plans (Details 2) - Outstanding options - USD ($) $ / shares in Units, shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Shares | ||
Outstanding at the beginning of the period (in shares) | 2,723 | |
Granted (in shares) | 1,472 | |
Exercised (in shares) | (56) | |
Canceled (in shares) | (345) | |
Outstanding at the end of the period (in shares) | 3,794 | 2,723 |
Exercisable at the end of the period (in shares) | 1,763 | |
Vested or expected to vest at the end of the period (in shares) | 3,794 | |
Weighted- Average Exercise Price | ||
Outstanding at the beginning of the period (in dollars per share) | $ 7.60 | |
Granted (in dollars per share) | 3.51 | |
Exercised (in dollars per share) | 2.96 | |
Canceled (in dollars per share) | 8.46 | |
Outstanding at the end of the period (in dollars per share) | 6.01 | $ 7.60 |
Exercisable at the end of the period (in dollars per share) | 6.09 | |
Vested or expected to vest at the end of the period (in dollars per share) | $ 6.01 | |
Weighted- Average Remaining Contractual Term (years) | ||
Outstanding at the beginning/end of the period | 7 years 8 months 27 days | 7 years 7 months 10 days |
Exercisable at the end of the period | 6 years 5 months 19 days | |
Vested or expected to vest at the end of the period | 7 years 8 months 27 days | |
Aggregate Intrinsic Value | ||
Outstanding at the end of the period (in dollars) | $ 4,708 | $ 2,840 |
Exercisable at the end of the period (in dollars) | 2,627 | |
Vested or expected to vest at the end of the period (in dollars) | $ 4,708 |
Stock and employee benefit pl33
Stock and employee benefit plans (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Additional disclosures | ||||
Stock-based compensation expense | $ 1,119 | $ 878 | $ 3,113 | $ 2,824 |
Performance-based stock options | ||||
Additional disclosures | ||||
Options outstanding (in shares) | 56,336 | 56,336 | ||
Employee stock purchase plan | 2014 ESPP | ||||
Additional disclosures | ||||
Number of shares of common stock authorized under the plan | 200,776 | 200,776 | ||
Option period | 6 months | |||
Shares remaining for future issuance (in shares) | 112,073 | 112,073 | ||
Stock-based compensation expense | $ 45 | $ 30 | $ 110 | $ 83 |