Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Jan. 31, 2017 | Jun. 30, 2016 | |
Document and Entity Information | |||
Entity Registrant Name | Nivalis Therapeutics, Inc. | ||
Entity Central Index Key | 1,626,199 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2016 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 54,062,337 | ||
Entity Common Stock, Shares Outstanding | 15,656,251 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 24,203 | $ 24,991 |
Marketable securities | 36,832 | 62,263 |
Prepaid expenses and other current assets | 628 | 432 |
Total current assets | 61,663 | 87,686 |
Property and equipment and other assets, net | 272 | 223 |
Total assets | 61,935 | 87,909 |
Current liabilities: | ||
Accounts payable | 1,921 | 994 |
Accrued direct program expenses | 2,646 | 1,555 |
Accrued employee benefits | 1,879 | 1,675 |
Accrued other liabilities | 53 | 195 |
Total current liabilities | 6,499 | 4,419 |
Commitments and contingencies | ||
Stockholders' equity (deficit): | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized for both periods presented; no shares issued and outstanding | ||
Common stock, $0.001 par value; 200,000,000 shares authorized for both periods presented; 15,565,973 and 15,462,030 shares issued and outstanding, respectively | 16 | 15 |
Additional paid-in capital | 235,737 | 232,309 |
Accumulated other comprehensive income (loss) | (17) | 3 |
Accumulated deficit | (180,300) | (148,837) |
Total stockholders' equity (deficit) | 55,436 | 83,490 |
Total liabilities and stockholders' equity (deficit) | $ 61,935 | $ 87,909 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Balance Sheets | ||
Convertible preferred stock with liquidation preference, shares outstanding | 0 | 0 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 15,565,973 | 15,462,030 |
Common stock, shares outstanding | 15,565,973 | 15,462,030 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss $ in Thousands | 12 Months Ended |
Dec. 31, 2014USD ($)$ / sharesshares | |
Operating expenses: | |
Research and development | $ 12,200 |
General and administrative | 2,287 |
Loss from operations | (14,487) |
Interest and other income, net | 296 |
Interest expense | (845) |
Net loss | (15,036) |
Gain on extinguishment of convertible debt as a capital transaction | 378 |
Net loss attributable to common stockholders | (14,658) |
Comprehensive loss | $ (14,658) |
Weighted average shares outstanding - basic and diluted (in shares) | shares | 723 |
Net loss per share attributable to common stockholders - basic and diluted (in dollars per share) | $ / shares | $ (20.27) |
Statement of Convertible Prefer
Statement of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total |
Balance, beginning at Dec. 31, 2013 | $ 19,693 | $ (110,983) | $ (91,288) | ||
Balance, beginning (in shares) at Dec. 31, 2013 | 171 | ||||
Recapitalization | $ 2 | 90,120 | 90,120 | ||
Recapitalization (in shares) | 2,040 | ||||
Gain on extinguishment of convertible debt | 378 | 378 | |||
Restricted stock units forfeited (in shares) | (1) | ||||
Exercise of incentive stock options | 2 | 2 | |||
Exercise of incentive stock options (in shares) | 1 | ||||
Reclass of preferred stock warrant liabilities to equity | 2 | 2 | |||
Employee stock-based compensation expense | 70 | 70 | |||
Net loss | (15,036) | (15,036) | |||
Balance, ending at Dec. 31, 2014 | $ 2 | 110,265 | (126,019) | (15,752) | |
Balance, ending (in shares) at Dec. 31, 2014 | 2,211 | ||||
Conversion of convertible preferred stock to common stock | $ 7 | 41,873 | 41,880 | ||
Conversion of convertible preferred stock to common stock (in shares) | 6,916 | ||||
Issuance of common stock, net of costs | $ 6 | 78,765 | 78,771 | ||
Issuance of common stock, net of costs (in shares) | 6,325 | ||||
Issuance of common stock under employee share plans and awards | 63 | 63 | |||
Issuance of common stock under employee share plans and awards (in shares) | 10 | ||||
Employee stock-based compensation expense | 1,343 | 1,343 | |||
Unrealized gains (losses) on marketable securities | $ 3 | 3 | |||
Net loss | (22,818) | (22,818) | |||
Balance, ending at Dec. 31, 2015 | $ 15 | 232,309 | 3 | (148,837) | 83,490 |
Balance, ending (in shares) at Dec. 31, 2015 | 15,462 | ||||
Issuance of common stock, net of costs | 20 | 20 | |||
Issuance of common stock, net of costs (in shares) | 20 | ||||
Issuance of common stock under employee share plans and awards | $ 1 | 145 | 146 | ||
Issuance of common stock under employee share plans and awards (in shares) | 84 | ||||
Employee stock-based compensation expense | 3,263 | 3,263 | |||
Unrealized gains (losses) on marketable securities | (20) | (20) | |||
Net loss | (31,463) | (31,463) | |||
Balance, ending at Dec. 31, 2016 | $ 16 | $ 235,737 | $ (17) | $ (180,300) | $ 55,436 |
Balance, ending (in shares) at Dec. 31, 2016 | 15,566 |
Statement of Convertible Prefe6
Statement of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Temporary Equity) - 12 months ended Dec. 31, 2014 - USD ($) shares in Thousands, $ in Thousands | 2013 NotesSeries E Convertible Preferred Stock | 2014 NotesSeries 1 Convertible Preferred Stock | Series 1 Convertible Preferred Stock | Series 2 Convertible Preferred Stock | Series A-2 Convertible Preferred Stock | Series C-1 Convertible Preferred Stock | Series C-2 Convertible Preferred Stock | Series D Convertible Preferred Stock | Series E Convertible Preferred Stock | Series A-1 Convertible Preferred Stock | Total |
Balance, beginning at Dec. 31, 2013 | $ 9,000 | $ 18,155 | $ 19,980 | $ 15,675 | $ 14,983 | $ 2 | |||||
Balance, beginning (in shares) at Dec. 31, 2013 | 1,393 | 2,811 | 2,379 | 7,203 | 4,266 | 1,992 | |||||
Conversion of notes payable, net of issuance costs | $ 12,326 | $ 12,329 | $ 24,655 | ||||||||
Conversion of notes payable, net of issuance costs (in shares) | 3,528 | 8,813 | |||||||||
Recapitalization | $ (9,000) | $ (18,155) | $ (19,980) | $ (15,675) | $ (27,309) | $ (2) | 90,120 | ||||
Recapitalization (in shares) | (1,393) | (2,811) | (2,379) | (7,203) | (7,794) | (1,992) | |||||
Gain on extinguishment of convertible debt | $ (384) | $ 378 | |||||||||
Sale of convertible preferred stock, net of issuance costs | $ 29,935 | ||||||||||
Sale of convertible preferred stock, net of issuance costs (in shares) | 11,166 | ||||||||||
Balance, ending at Dec. 31, 2014 | $ 11,945 | $ 29,935 | |||||||||
Balance, ending (in shares) at Dec. 31, 2014 | 8,813 | 11,166 |
Statement of Convertible Prefe7
Statement of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Millions | Jun. 22, 2015 | Dec. 31, 2015 |
Statement of Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||
Issuance of common stock, costs | $ 3.6 | $ 9.8 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating activities | |||
Net loss | $ (31,463) | $ (22,818) | $ (15,036) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and loss on disposal of assets | 143 | 66 | 88 |
Stock-based compensation expense | 3,263 | 1,343 | 70 |
Change in value of preferred stock warrant liabilities and derivative | (296) | ||
Amortization of deferred financing costs and noncash interest | 708 | ||
Changes in operating assets and liabilities: | |||
Prepaid expenses and other | (282) | 198 | (380) |
Accounts payable | 927 | 65 | 258 |
Accrued direct program expenses | 1,091 | 311 | 355 |
Accrued employee benefits | 204 | 1,465 | (183) |
Accrued other liabilities | (142) | 163 | (32) |
Net cash used in operating activities | (26,259) | (19,207) | (14,448) |
Investing activities | |||
Purchases of property and equipment | (106) | (188) | (4) |
Purchases of marketable securities | (75,324) | (76,260) | |
Proceeds from maturities and sales of marketable securities | 100,735 | 14,000 | |
Net cash provided by (used in) investing activities | 25,305 | (62,448) | (4) |
Financing activities | |||
Proceeds from issuance of common stock, net of offering costs | 20 | 78,771 | |
Proceeds from issuance of common stock under employee share plans | 146 | 63 | 2 |
Proceeds from issuance of convertible preferred stock, net | 29,935 | ||
Decrease in restricted cash | 2,500 | ||
Proceeds from notes payable, net | 11,868 | ||
Principal payment on debt | (3,139) | ||
Net cash provided by financing activities | 166 | 78,834 | 41,166 |
Net increase (decrease) in cash and cash equivalents | (788) | (2,821) | 26,714 |
Cash and cash equivalents, beginning of period | 24,991 | 27,812 | 1,098 |
Cash and cash equivalents, end of period | $ 24,203 | 24,991 | 27,812 |
Supplemental disclosures of cash flow information | |||
Cash paid for interest | 165 | ||
Conversion of convertible preferred stock to common stock | $ 41,880 | ||
Conversion of convertible debt and accrued interest to convertible preferred stock, net | $ 24,655 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2016 | |
Organization and Description of Business | |
Organization and Description of Business | 1. Organization and Description of Business Nivalis Therapeutics, Inc. (the “Company” or “Nivalis”), incorporated in Delaware on August 1, 2012, is a pharmaceutical company that has historically focused on the discovery and development of product candidates for patients with cystic fibrosis, or CF. |
Liquidity Risks
Liquidity Risks | 12 Months Ended |
Dec. 31, 2016 | |
Liquidity Risks | |
Liquidity Risks | 2. Liquidity Risks The Company has incurred operating losses and has an accumulated deficit as a result of ongoing research and development spending. As of December 31, 2016, the Company had an accumulated deficit of $180.3 million. For the year ended December 31, 2016, net loss was $31.5 million and net cash used in operating activities was $26.3 million. In November 2016, the Company announced that its Phase 2 trial, evaluating the efficacy and safety of cavosonstat in adult patients with CF, had failed to demonstrate a benefit in its primary endpoint. On January 3, 2017, the Company announced that its Board of Directors had initiated a process to explore and review a range of strategic alternatives. At that time, the Company engaged financial advisors and established a Special Committee of the Board to explore strategic alternatives. As announced on January 12, 2017, the Company committed to a restructuring plan that consisted primarily of a workforce reduction of 25 positions, to a total of 5 remaining positions in order to conserve cash while the Company continues to evaluate business alternatives. In connection with this restructuring, the Company discontinued a substantial portion of its research and clinical development activities and no longer anticipates expending material resources on any of its drug candidates to reduce expenditures. After considering the actions taken by management, the Company has sufficient cash and marketable securities to fund operations for at least the next twelve months. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include all adjustments necessary for the presentation of the Company’s financial position, results of operations and cash flows for the periods presented. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes, including accrued liabilities and the fair value-based measurement of equity instruments. Actual results could differ materially from those estimates. The Company evaluates its estimates and assumptions as facts and circumstances dictate. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest- bearing and demand money market accounts. Marketable Securities The Company has designated marketable securities as available-for-sale securities and accounts for them at their respective fair values. Marketable securities are classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Securities that are classified as available-for-sale are carried at fair value, including accrued interest, with temporary unrealized gains and losses reported as a component of stockholders' equity until their disposition. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s then current intent and ability to sell the security if it is required to do so. The cost of securities sold is based on the specific identification method. All marketable securities are subject to a periodic impairment review. The Company will recognize an impairment charge when a decline in the fair value of the investments below the cost basis is judged to be other-than-temporary. Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company has established guidelines to limit its exposure to credit risk by placing investments with high credit quality financial institutions, diversifying its investment portfolio and making investments with maturities that maintain safety and liquidity. At December 31, 2016 and 2015, the Company’s cash equivalents were with money market funds that invest in securities issued by the U.S. Treasury. At December 31, 2016 and 2015, the Company’s marketable securities were in U.S. Treasury securities, obligations of U.S. government agencies, reverse repurchase agreements and high-grade corporate debt securities. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Lab equipment, computer equipment and software are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are depreciated over the shorter of the estimated useful lives of the assets or the lease term. Maintenance and repairs are expensed as incurred. Impairment of Long-Lived Assets The Company assesses the potential impairments of its long-lived assets whenever events or changes in circumstances indicate that an asset's carrying value may not be recoverable. If the carrying value exceeds the undiscounted future cash flows estimated to result from the use and eventual disposition of the asset, the Company writes down the asset to its estimated fair value. Management believes that no long-lived assets were materially impaired as of December 31, 2016 and 2015. Accrued Direct Program Expenses Substantial portions of the Company’s preclinical studies and clinical trials, including the manufacture and packaging of drug supplies, are performed by third-party laboratories, contract manufacturing organizations, medical centers, contract research organizations and other service providers (collectively vendors). These vendors generally bill monthly or quarterly for services performed or upon achieving certain milestones. For preclinical studies and product development and manufacturing, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon patient enrollment and the duration of the study. The Company monitors patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported by these vendors using software tracking systems, or through clinical site visits and vendor correspondence. Company estimates depend on the timeliness and accuracy of the data provided by these vendors regarding the status of each program and total program spending. The Company periodically evaluates these estimates to determine if adjustments are necessary or appropriate based on information received. No vendor comprised more than 10% of all external costs in 2016, 2015, and 2014. Research and Development The Company expenses costs associated with research and development as incurred. These costs include direct program expenses, which are payments made to third parties that specifically relate to the Company’s research and development, such as payments to clinical research organizations, clinical investigators, manufacturing of clinical material, pre-clinical testing and consultants. In addition, employee costs (salaries, payroll taxes, benefits and travel) for employees contributing to research and development activities are classified as research and development costs. Stock-Based Compensation The Company measures employee and director stock-based compensation expense for all stock and purchase awards at the grant date based on the fair value measurement of the award. The expense is recorded over the related service period, generally the vesting period, net of estimated forfeitures. Any changes to the estimated forfeiture rates are accounted for prospectively. The Company calculates the fair value measurement of stock options using the Black-Scholes valuation model and the single-option method and recognizes expense using the straight-line attribution approach. Income Taxes The Company accounts for income taxes under an asset and liability approach. Deferred income taxes reflect the impact of temporary differences between assets and liabilities recognized for tax and financial reporting purposes measured by applying enacted tax rates and laws that will be in effect when the differences are expected to reverse, net operating loss and tax credit carryforwards. Tax benefits are recorded when the benefit is more likely than not to be sustained upon audit. The Company accrues interest and penalties related to uncertain tax positions in income tax expense. Valuation allowances are provided when necessary to reduce net deferred tax assets to an amount that is more likely than not to be realized. Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on discovering and developing potential drugs. No revenue has been generated since inception, and all tangible assets are held in the United States. Comprehensive Loss Comprehensive loss is comprised of net loss and adjustments for the change in unrealized gains and losses on the Company’s investments in available-for-sale marketable securities. The Company presents comprehensive loss and its components in the statements of operations and comprehensive loss for the year ended December 31, 2016 and 2015. Net Loss per Share The Company reports net loss per share in accordance with the standard codification of ASC “Earnings per Share” (“ASC 260”). Under ASC 260, basic earnings per share, which excludes dilution, is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted earnings per share reflects the potential dilution of securities that could be exercised or converted into common shares, and is computed by dividing net loss by the weighted average of common shares outstanding plus the dilutive potential common shares. Diluted earnings per share excludes the impact of options to purchase common stock, restricted stock units and warrants to purchase common stock, as the effect would be anti-dilutive. During a loss period, the assumed exercise of in-the-money stock options and other potentially diluted instruments has an anti-dilutive effect and therefore, these instruments are excluded from the computation of dilutive earnings per share. Recently Adopted Accounting Pronouncements In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern, which requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern and to provide disclosures when certain criteria are met. The guidance is effective for annual periods beginning after December 15, 2016 and interim reporting periods starting in the first quarter of 2017. The Company adopted this standard as of December 31, 2016. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The new guidance requires organizations that lease assets to recognize assets and liabilities on the balance sheet related to the rights and obligations created by those leases, regardless of whether they are classified as finance or operating leases. Consistent with current guidance, the recognition, measurement, and presentation of expenses and cash flows arising from a lease primarily will depend on its classification as a finance or operating lease. The guidance also requires new disclosures to help financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. The new standard is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, with early application permitted. The new standard is to be applied using a modified retrospective approach. The Company does not expect the standard will have a material impact on its disclosures. In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The amendments in this update simplify several aspects of the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures, statutory tax withholding requirements, as well as classification within the statement of cash flows. The guidance will be effective for the annual periods beginning after December 15, 2016, and interim periods within those annual periods. The Company is currently evaluating the impact of the new pronouncement on its financial statements. Fair Value of Financial Instruments The carrying amounts of cash equivalents and marketable securities approximate their fair value based upon quoted market prices. Certain financial instruments are not measured at fair value on a recurring basis, but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as cash, accounts payable, accrued direct program expenses, and accrued employee benefits , and other financial instruments included within current assets or current liabilities. The Company accounted for warrants to purchase its redeemable preferred stock pursuant to ASC Topic 480, Distinguishing Liabilities from Equity , and classified them as liabilities. The fair value of the outstanding preferred stock warrant liabilities at December 31, 2013 was $267,750. Subsequent to the completion of the Stock Conversion on September 23, 2014, whereby all outstanding shares of preferred stock were converted into shares of common stock, and the warrants became exercisable for shares of common stock pursuant to the adjustment provisions of the warrants, the fair value of the preferred stock warrant liabilities was remeasured and reclassified into equity. During the year ended December 31, 2014 a remeasurement gain of $265,750 was recognized in interest and other income, net in the statement of operations and comprehensive loss. Upon the Stock Conversion, the remaining balance of $2,000 was reclassified from liabilities to equity. Fair Value Measurements In general, asset and liability fair values are determined using the following categories: Level 1 – inputs utilize quoted prices in active markets for identical assets or liabilities. Level 2 – inputs include quoted prices for similar assets or liabilities in active markets, and inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. Level 3 – inputs are unobservable inputs and include situations where there is little, if any, market activity for the balance sheet items at period end. Pricing inputs are unobservable for the terms and are based on the Company’s own estimates about the assumptions that a market participant would use in pricing as asset. The Company’s financial instruments, including money market investments, reverse repurchase agreements, corporate debt securities, U.S. Treasury securities and obligations of U.S. government agencies, are measured at fair value on a recurring basis. There were no transfers between levels for the years ended December 31, 2016 and 2015. Assets and liabilities measured at fair value on a recurring basis consisted of the following types of instruments as of December 31, 2016 and 2015 (in thousands): Quoted prices Quoted prices Quoted prices Quoted prices in active for similar assets in active for similar assets markets for observable in the markets for observable in the December 31, identical assets marketplace December 31, identical assets marketplace Description 2016 (Level 1) (Level 2) 2015 (Level 1) (Level 2) Assets measured at fair value: Money market investments $ $ $ — $ $ $ — U.S. Treasury securities, obligations of U.S. government agencies, corporate debt securities and reverse repurchase agreements — — |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 12 Months Ended |
Dec. 31, 2016 | |
Cash, Cash Equivalents and Marketable Securities | |
Cash, Cash Equivalents and Marketable Securities | 4. Cash, Cash Equivalents and Marketable Securities The following is a summary of cash, cash equivalents and marketable securities as of December 31, 2016 and 2015 (in thousands): Gross unrealized Gross unrealized Fair market Amortized Cost gains losses value December 31, 2016 Cash $ $ – $ – $ Money market funds – – Reverse repurchase agreements – – U.S. Treasury securities and obligations of U.S. government agencies Corporate debt securities Total for December 31, 2016 $ $ $ $ December 31, 2015 Cash $ $ – $ – $ Money market funds – – Reverse repurchase agreements – – U.S. Treasury securities and obligations of U.S. government agencies Corporate debt securities Total for December 31, 2015 $ $ $ $ |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property and Equipment | |
Property and Equipment | 5. Property and Equipment Property and equipment consisted of the following as of December 31, 2016 and 2015 (in thousands): Estimated Useful Life December 31, (in years) 2016 2015 Lab equipment 5 $ $ Computer equipment and software 3 Leasehold improvements 1 Total Less accumulated depreciation Property and equipment, net $ $ Depreciation expenses were approximately $143,000, $66,000 and $86,000 for the years ended December 31, 2016, 2015 and 2014, respectively. |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2016 | |
Notes Payable | |
Notes Payable | 6. Notes Payable As of December 31, 2016, the Company had no debt outstanding. Convertible Debt During February 2014 through September 2014, the Company issued subordinated secured convertible promissory notes (the “2014 Notes”), to two related party investors totaling $12.0 million at an interest rate of 8.0% per annum. The outstanding principal and accrued and unpaid interest was convertible at the option of the investor into preferred shares in the Company. The 2014 Notes included a change in control redemption which was deemed an embedded derivative. This redemption right and the right to convert at 75% of the price at which a new series of preferred stock was issued required the Company to bifurcate and separately account for the embedded derivatives, however the amount recorded and the impact on net loss was not material. As part of the Stock Conversion on September 23, 2014, the holders of the 2014 Notes agreed to the issuance of shares of a newly created Series 1 convertible preferred stock in settlement of the 2014 Notes. The Company issued 8,813,203 Series 1 convertible preferred shares at a price of $1.40 per share through the settlement of $12,373,741 of convertible debt and related interest held by two separate investors. This transaction resulted in a gain on extinguishment of $378,251, which was recognized through equity during the year ended December 31, 2014, as this was a transaction with stockholders. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Lease The Company has a lease obligation for office and laboratory space, which will expire on March 31, 2018. The Company has the option to renew the lease for an additional three-year term and has the option to terminate the lease at any time after March 31, 2017, for a termination fee of $25,000. The approximate future minimum payments under these lease arrangements as of December 31, 2016, are as follows (in thousands): 2017 $ 2018 Total $ During 2016, 2015 and 2014, the Company incurred approximately $279,000, $267,000 and $225,000 for rent expense, respectively. Purchase Commitments The Company has entered into contracts with external parties to provide the Company future services, which include research and development, clinical development support and testing services. As of December 31, 2016, the Company’s obligation for future services under these contracts approximated $1.7 million. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Convertible Preferred Stock Immediately prior to the Stock Conversion, the Company had six series of outstanding convertible preferred stock: Series A-1 convertible preferred stock, Series A-2 convertible preferred stock, Series C-1 convertible preferred stock, Series C-2 convertible preferred stock, Series D convertible preferred stock and Series E convertible preferred stock. The convertible preferred stock was initially recorded at the issuance price on the date of issuance, net of issuance costs. As a result of the Stock Conversion on September 23, 2014, all outstanding preferred stock was converted into shares of common stock on an 11.556-for-1 basis. Concurrent with the Stock Conversion, a newly created Series 1 convertible preferred stock was issued in the settlement of the 2014 Notes. In November and December 2014, the Company raised $31.0 million gross proceeds in a private placement of Series 2 convertible preferred stock. On June 22, 2015, prior to the closing of the Company’s IPO, all outstanding shares of convertible preferred stock, amounting to 19,978,986 shares, were automatically converted into 6,915,525 shares of common stock in accordance with the terms of the Company’s amended and restated certificate of incorporation then in existence. As of December 31, 2016 and 2015, the Company had no preferred stock or convertible preferred stock outstanding. Common Stock On June 22, 2015, the Company completed its IPO of 6,325,000 shares of its common stock, including 875,000 shares from the exercise of the underwriters’ over-allotment option, at a price to the public of $14.00 per share for aggregate gross proceeds of $88.6 million. The Company received proceeds of $78.8 million from its IPO, net of $3.6 million in expenses and $6.2 million in underwriters’ discounts and commissions relating to the issuance and distribution of the securities. On April 18, 2016, in connection with the appointment of the Company’s new Chief Medical Officer, the Company approved a grant of stock options to purchase 108,333 shares of the Company’s common stock (the “Options”) and 216,667 restricted stock units (“RSUs”). The Options and RSUs were issued pursuant to a separate Notice of Inducement Stock Option Grant and Inducement Stock Option Agreement and Notice of Restricted Stock Unit Inducement Grant and Inducement Restricted Stock Unit Agreement and are considered inducement grants made in accordance with NASDAQ Listing Rule 5635(c)(4). On July 5, 2016, the Company filed a registration statement on Form S-3 that was declared effective on July 14, 2016 registering (i) the offering, issuance and sale of up to $125,000,000 in the aggregate of an indeterminate number of shares of common stock and preferred stock, an indeterminate principal amount of debt securities and an indeterminate number of warrants and (ii) the resale of up to 3,732,412 shares of common stock by selling stockholders pursuant to a base prospectus that forms a part of the registration statement. The registration statement also registers the offering, issuance and sale of the Company’s common stock having up to a maximum aggregate offering price of $20,000,000 that may be issued and sold in an at-the-market offering under a sales agreement the Company entered into with Cowen and Company, LLC on July 5, 2016 pursuant to a sales agreement prospectus that forms a part of the registration statement. The $20,000,000 of common stock that may be sold under the sales agreement prospectus is included in the $125,000,000 that may be sold by the Company under the base prospectus. As of December 31, 2016, approximately 20,000 shares of common stock have been sold at an average sales price of $8.00 per share under the sales agreement, net of offering costs of approximately $140,000. At December 31, 2016, shares of common stock have been reserved for issuance as follows: Options to purchase common stock - issued Options to purchase common stock - unissued Inducement grants - issued Employee stock purchase plan - unissued Warrants to purchase common stock Total Stock-Based Compensation Stock Options and Restricted Stock Units In August 2012, the Company adopted the 2012 Stock Incentive Plan (the “2012 Plan”). A total of 147,109 shares of common stock were originally reserved for issuance under the 2012 Plan. On November 17, 2014, and December 12, 2014, the Company’s Board of Directors approved an increase of 623,052 and 519,210 shares, respectively, to the total number of shares that may be issued under the 2012 Plan, which after these increases totaled 1,289,371 shares. As of December 31, 2015, 1,288,174 accumulated shares had been granted under the 2012 Plan to employees and directors, while 685 shares had been exercised and 512 shares were terminated upon the termination of the 2012 Plan effective with the closing of the Company’s IPO. In May 2015, the Company’s Board of Directors and its stockholders approved the 2015 Equity Incentive Plan (the “2015 Plan”). Effective with the Company’s IPO closing, a total of 1,081,700 shares of common stock were originally reserved for issuance under the 2015 Plan. The 2015 Plan provides that an additional number of shares will automatically be added to the shares authorized for issuance under the 2015 Plan on January 1 of each calendar year, from January 1, 2016 through January 1, 2025. The number of shares added each year will be equal to: (a) 5% of the total number of shares of Common Stock issued and outstanding on December 31 of the preceding calendar year; or (b) such lesser number of shares of Common Stock approved by the Board of Directors on or prior to such immediately preceding December 31. On January 1, 2016 a total of 773,102 additional shares were automatically added to the shares authorized for issuance under the 2015 Plan. The 2015 Plan provides for the granting of incentive and nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance-based awards and other stock-based awards to its employees, directors and consultants. Stock options granted vest over either a one-year period or three-year period for Board of Director grants or over a four-year period for employee grants and expire 10 years from the date of grant. The fair value of each option grant for the year ended December 31, 2016 and 2015 was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: 2016 2015 Estimated dividend yield – – Weighted-average expected stock price volatility % % Weighted-average risk-free interest rate % % Weighted-average expected life of option (in years) Weighted-average fair value per option $ $ There were no stock options granted during the year ended December 31, 2014 Due to limited historical data, the Company estimates stock price volatility based on the actual volatility of comparable publicly traded companies over the expected life of the option. The expected term represents the average time that options that vest are expected to be outstanding. The Company does not have sufficient history of exercise of stock options to estimate the expected term for employee stock options and, thus, continues to calculate expected life based on the midpoint between the average vesting date and the contractual term, which is in accordance with the simplified method. The risk-free rate is based on the United States Treasury yield curve for the expected life of the option. The fair value of the common stock utilized in the fair value estimation of option and restricted stock arrangements prior to the Company’s IPO of June 2015 has been determined utilizing contemporaneous valuations primarily based on an option pricing methodology. The tables below summarize the stock option activity for the year ended December 31, 2016: Weighted - Average Remaining Weighted Contractual Aggregate Options Average Life Intrinsic Outstanding Exercise Price (in Years) Value Balance as of December 31, 2015 $ Granted Exercised Forfeited Canceled or Expired Balance as of December 31, 2016 $ – Exercisable at December 31, 2016 – Options expected to vest, net of estimated forfeitures $ $ – A summary of the status of our non-vested RSUs as of December 31, 2016 and changes during the year ended December 31, 2016, is presented below: Weighted Number of Average RSUs Grant Date Fair Value Unvested as of December 31, 2015 – $ - Granted Vested Unvested as of December 31, 2016 $ During 2016, 2015 and 2014, the Company recorded approximately $3.3 million, $1.3 million and $70,000, respectively, in stock-based compensation expense for the vesting of stock options and RSUs. No stock options or RSUs have been granted to consultants. As of December 31, 2016, there was approximately $10.0 million of total unrecognized stock-based compensation expense related to nonvested stock options and nonvested RSUs, net of related forfeiture estimates. During the first quarter of 2017, we expect to record approximately $2.3 million of stock-based compensation expense due to the accelerated vesting of options and RSUs offered to employees affected by the restructuring plan and workforce reduction announced on January 12, 2017. The Company did not recognize a tax benefit related to stock-based compensation expense during the years ended December 31, 2016, 2015 and 2014 as the Company maintains net operating loss carryforwards and has established a valuation allowance against the entire net deferred tax asset as of December 31, 2016. Employee Stock Purchase Plan In May 2015, the Company’s Board of Directors and its stockholders approved the Nivalis Therapeutics, Inc. Employee Stock Purchase Plan (the “Purchase Plan”). Effective on the closing of the Company’s IPO, a total of 231,800 shares of common stock were made available for sale under the Purchase Plan. The Purchase Plan may be amended, suspended or terminated at any time by the Board of Directors, however stockholder approval is required to increase the number of common stock available under the Purchase Plan or to change the employees eligible to participate in the Purchase Plan. The Purchase Plan provides for a series of successive six-month offering periods, from January to June and July to December of each calendar year during which participating employees may elect to have up to 15% of their compensation withheld and applied to the purchase of common stock at the end of each offering period. The purchase price of the common stock is 85% of the lower of the fair value of a share of common stock on the first trading date of each offering period or the fair value of a share of common stock on the last trading day of the offering period. The Company sold 42,031 and 8,924 shares to employees during 2016 and 2015, respectively. There were 180,845 shares available for sale under the Purchase Plan as of December 31, 2016. The weighted-average estimated grant date fair value of purchase awards under the Purchase Plan during the year ended December 31, 2016 and 2015 was $1.98 and $5.18, respectively. The total stock-based compensation expense recorded as a result of the Purchase Plan was approximately $73,000 and $22,000 during the year ended December 31, 2016 and 2015, respectively. The fair value of purchase awards granted to our employees during the year ended December 31, 2016 and 2015 was estimated using the Black-Scholes option pricing model using the weighted-average assumptions provided in the following table: 2016 2015 Estimated dividend yield – – Expected stock price volatility % % Risk-free interest rate % % Expected life of option (in years) The Company estimates stock price volatility based on the actual volatility of its publicly traded stock over the expected life of the purchase right. The risk-free rate is based on the U.S. Treasury yield in effect at the time of grant with terms similar to the contractual term of the purchase right. The expected term represents the six-month offering period for the Purchase Plan. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Taxes | |
Income Taxes | 9. Income Taxes No provision for federal or state income tax expense has been recorded for the years ended December 31, 2016, 2015 and 2014, since the Company generated net operating losses in all years. Deferred income taxes reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities at December 31, 2016 and 2015 are as follows (in thousands): 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Income tax credit carryforwards Accrued benefits and other Stock-based compensation – Property and equipment – Intangible assets Valuation allowance Net deferred tax assets – Deferred tax liabilities: Property and equipment – $ – $ – The Company records a full valuation allowance against its net deferred tax assets since the Company cannot conclude that it was more likely than not that its deferred tax assets would be realized. At December 31, 2016, the Company had federal and state income loss carryforwards of $75.7 million and $83.0 million, respectively, that begin to expire in 2032 for both federal and state purposes. Additionally, the Company has research and development credits and orphan drug credits of approximately $2.0 million and $7.3 million, respectively, available for federal purposes, which begin to expire in 2032 and 2036, respectively. The utilization of the federal net operating loss and credit carryforwards to reduce future income taxes will depend on the Company’s ability to generate sufficient taxable income prior to the expiration of the carryforwards. In addition, the utilization of the federal net operating loss and credit carryforwards may be subject to limitations under the rules regarding a change in stock ownership as determined by the Internal Revenue Code and state laws. Section 382 of the Internal Revenue Code of 1986, as amended, imposes annual limitations on the utilization of net operating loss (“NOL”) carryforwards, other tax carryforwards and certain built-in losses upon an ownership change as defined by that section. In general terms, an ownership change may result from transactions that increase the aggregate ownership of certain stockholders in the Company stock by more than 50 percentage points over a three year testing period (“Section 382 Ownership Change”). If the Company has undergone a Section 382 Ownership change, an annual limitation would be imposed on certain tax attributes of the Company, including NOL and capital loss carryforwards and certain other losses and credits. As of December 31, 2016, the Company has not performed a formal study to determine whether there are Section 382 limitations that apply and such limitations could be significant. The difference between actual income tax rate for the years ended December 31, 2016, 2015 and 2014, and the statutory federal income tax rate are as follows: 2016 2015 2014 % of Pretax % of Pretax % of Pretax Earnings Earnings Earnings Income tax benefit at statutory rate % % % State income taxes, net of federal tax benefit % % % Income tax credits % % % Nondeductible expenses and other % % % Change in valuation allowance % % % Income tax expense (benefit) % % % As of December 31, 2016 and 2015, the Company had no unrecognized tax benefits. The Company has analyzed its filing positions in all significant federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal, state and local tax examinations by taxing authorities for years before 2013. No income tax returns are currently under examination by taxing authorities . |
Employment Benefit Plan
Employment Benefit Plan | 12 Months Ended |
Dec. 31, 2016 | |
Employment Benefit Plan | |
Employment Benefit Plan | 10. Employment Benefit Plan The Company outsources its payroll, benefits and human resource administration functions to a Professional Employer Organization (PEO). The Company’s employees are eligible to participate in the PEO’s Multiple Employer Retirement Savings Plan (401(k) plan). The 401(k) plan allows immediate participation by U.S. employees that are 20 years of age or older. Participants may defer up to 75% of their gross pay, up to a maximum limit determined by U.S. federal law. The Company provides all active employees with a safe harbor contribution equal to 3% of compensation (regardless of participation in the 401(k) plan) up to maximum U.S. federal law limits. These safe harbor contributions vest immediately. During 2016, 2015 and 2014, the Company paid approximately $150,000, $115,000 and $129,000, respectively, for employer contributions and plan expenses. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2016 | |
Net Loss per Share | |
Net Loss per Share | 11. Net Loss per Share The Company excluded the following common stock equivalents, outstanding as of the years ended December 31, 2016, 2015 and 2014, from the computation of diluted net loss per share for these same periods because they had an anti-dilutive impact on the computation: December 31, 2016 2015 2014 Options to purchase common stock - issued Inducement grants - issued — — Unvested restricted common stock — Convertible preferred stock — — Warrants to purchase convertible preferred and common stock Total |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Data | |
Quarterly Financial Data | 12. Quarterly Financial Data (Unaudited) The results of operations on a quarterly basis for the years ended December 31, 2016 and 2015 were as follows (in thousands, except per share data): March 31, June 30, September 30, December 31, March 31, June 30, September 30, December 31, 2016 2016 2016 2016 2015 2015 2015 2015 Revenue $ — $ — $ — $ — $ — $ — $ — $ — Operating expenses: Research and development General and administrative Loss from operations Interest and other income, net — Interest expense — — — — — — — — Net loss $ $ $ $ $ $ $ $ Weighted average shares outstanding - basic and diluted Net loss per share - basic and diluted $ $ $ $ $ $ $ $ |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events In January 2017, following the failure of a Phase 2 trial of cavosonstat in patients with CF to meet its primary endpoint, the Company initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources. As a result, the Company ceased its research activities and further development of cavosonstat and its other GSNOR inhibitors and began implementation of a workforce reduction of 25 positions to better align its workforce to its revised operating plan. The workforce reduction will be substantially completed during the first quarter of 2017, at which time the Company expects to have approximately five remaining employees. Cash payments in connection with the workforce reduction, comprised principally of severance and benefits continuation costs, are estimated to be approximately $3.0 million and expected to be paid during the first half of 2017. In addition to severance payments, all unvested stock options held by employees affected by the workforce reduction were 100% vested and a portion of unvested RSUs held by one employee vested. As a result, the Company expects to record in the first quarter of 2017 approximately $2.3 million of stock-based compensation expense related to this accelerated vesting. The Company has not incurred, nor does it expect to incur, significant cancellation charges with its vendors as a result of winding down research and development activities. |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include all adjustments necessary for the presentation of the Company’s financial position, results of operations and cash flows for the periods presented. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes, including accrued liabilities and the fair value-based measurement of equity instruments. Actual results could differ materially from those estimates. The Company evaluates its estimates and assumptions as facts and circumstances dictate. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest- bearing and demand money market accounts. |
Marketable Securities | Marketable Securities The Company has designated marketable securities as available-for-sale securities and accounts for them at their respective fair values. Marketable securities are classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Securities that are classified as available-for-sale are carried at fair value, including accrued interest, with temporary unrealized gains and losses reported as a component of stockholders' equity until their disposition. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s then current intent and ability to sell the security if it is required to do so. The cost of securities sold is based on the specific identification method. All marketable securities are subject to a periodic impairment review. The Company will recognize an impairment charge when a decline in the fair value of the investments below the cost basis is judged to be other-than-temporary. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company has established guidelines to limit its exposure to credit risk by placing investments with high credit quality financial institutions, diversifying its investment portfolio and making investments with maturities that maintain safety and liquidity. At December 31, 2016 and 2015, the Company’s cash equivalents were with money market funds that invest in securities issued by the U.S. Treasury. At December 31, 2016 and 2015, the Company’s marketable securities were in U.S. Treasury securities, obligations of U.S. government agencies, reverse repurchase agreements and high-grade corporate debt securities. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Lab equipment, computer equipment and software are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are depreciated over the shorter of the estimated useful lives of the assets or the lease term. Maintenance and repairs are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the potential impairments of its long-lived assets whenever events or changes in circumstances indicate that an asset's carrying value may not be recoverable. If the carrying value exceeds the undiscounted future cash flows estimated to result from the use and eventual disposition of the asset, the Company writes down the asset to its estimated fair value. Management believes that no long-lived assets were materially impaired as of December 31, 2016 and 2015. |
Accrued Direct Program Expenses | Accrued Direct Program Expenses Substantial portions of the Company’s preclinical studies and clinical trials, including the manufacture and packaging of drug supplies, are performed by third-party laboratories, contract manufacturing organizations, medical centers, contract research organizations and other service providers (collectively vendors). These vendors generally bill monthly or quarterly for services performed or upon achieving certain milestones. For preclinical studies and product development and manufacturing, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon patient enrollment and the duration of the study. The Company monitors patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported by these vendors using software tracking systems, or through clinical site visits and vendor correspondence. Company estimates depend on the timeliness and accuracy of the data provided by these vendors regarding the status of each program and total program spending. The Company periodically evaluates these estimates to determine if adjustments are necessary or appropriate based on information received. No vendor comprised more than 10% of all external costs in 2016, 2015, and 2014. |
Research and Development | Research and Development The Company expenses costs associated with research and development as incurred. These costs include direct program expenses, which are payments made to third parties that specifically relate to the Company’s research and development, such as payments to clinical research organizations, clinical investigators, manufacturing of clinical material, pre-clinical testing and consultants. In addition, employee costs (salaries, payroll taxes, benefits and travel) for employees contributing to research and development activities are classified as research and development costs. |
Stock-Based Compensation | Stock-Based Compensation The Company measures employee and director stock-based compensation expense for all stock and purchase awards at the grant date based on the fair value measurement of the award. The expense is recorded over the related service period, generally the vesting period, net of estimated forfeitures. Any changes to the estimated forfeiture rates are accounted for prospectively. The Company calculates the fair value measurement of stock options using the Black-Scholes valuation model and the single-option method and recognizes expense using the straight-line attribution approach. |
Income Taxes | Income Taxes The Company accounts for income taxes under an asset and liability approach. Deferred income taxes reflect the impact of temporary differences between assets and liabilities recognized for tax and financial reporting purposes measured by applying enacted tax rates and laws that will be in effect when the differences are expected to reverse, net operating loss and tax credit carryforwards. Tax benefits are recorded when the benefit is more likely than not to be sustained upon audit. The Company accrues interest and penalties related to uncertain tax positions in income tax expense. Valuation allowances are provided when necessary to reduce net deferred tax assets to an amount that is more likely than not to be realized. |
Segment Information | Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on discovering and developing potential drugs. No revenue has been generated since inception, and all tangible assets are held in the United States. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is comprised of net loss and adjustments for the change in unrealized gains and losses on the Company’s investments in available-for-sale marketable securities. The Company presents comprehensive loss and its components in the statements of operations and comprehensive loss for the year ended December 31, 2016 and 2015. |
Net Loss per Share | Net Loss per Share The Company reports net loss per share in accordance with the standard codification of ASC “Earnings per Share” (“ASC 260”). Under ASC 260, basic earnings per share, which excludes dilution, is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted earnings per share reflects the potential dilution of securities that could be exercised or converted into common shares, and is computed by dividing net loss by the weighted average of common shares outstanding plus the dilutive potential common shares. Diluted earnings per share excludes the impact of options to purchase common stock, restricted stock units and warrants to purchase common stock, as the effect would be anti-dilutive. During a loss period, the assumed exercise of in-the-money stock options and other potentially diluted instruments has an anti-dilutive effect and therefore, these instruments are excluded from the computation of dilutive earnings per share. |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern, which requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern and to provide disclosures when certain criteria are met. The guidance is effective for annual periods beginning after December 15, 2016 and interim reporting periods starting in the first quarter of 2017. The Company adopted this standard as of December 31, 2016. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The new guidance requires organizations that lease assets to recognize assets and liabilities on the balance sheet related to the rights and obligations created by those leases, regardless of whether they are classified as finance or operating leases. Consistent with current guidance, the recognition, measurement, and presentation of expenses and cash flows arising from a lease primarily will depend on its classification as a finance or operating lease. The guidance also requires new disclosures to help financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. The new standard is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, with early application permitted. The new standard is to be applied using a modified retrospective approach. The Company does not expect the standard will have a material impact on its disclosures. In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The amendments in this update simplify several aspects of the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures, statutory tax withholding requirements, as well as classification within the statement of cash flows. The guidance will be effective for the annual periods beginning after December 15, 2016, and interim periods within those annual periods. The Company is currently evaluating the impact of the new pronouncement on its financial statements. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash equivalents and marketable securities approximate their fair value based upon quoted market prices. Certain financial instruments are not measured at fair value on a recurring basis, but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as cash, accounts payable, accrued direct program expenses, and accrued employee benefits , and other financial instruments included within current assets or current liabilities. The Company accounted for warrants to purchase its redeemable preferred stock pursuant to ASC Topic 480, Distinguishing Liabilities from Equity , and classified them as liabilities. The fair value of the outstanding preferred stock warrant liabilities at December 31, 2013 was $267,750. Subsequent to the completion of the Stock Conversion on September 23, 2014, whereby all outstanding shares of preferred stock were converted into shares of common stock, and the warrants became exercisable for shares of common stock pursuant to the adjustment provisions of the warrants, the fair value of the preferred stock warrant liabilities was remeasured and reclassified into equity. During the year ended December 31, 2014 a remeasurement gain of $265,750 was recognized in interest and other income, net in the statement of operations and comprehensive loss. Upon the Stock Conversion, the remaining balance of $2,000 was reclassified from liabilities to equity. |
Fair Value Measurements | Fair Value Measurements In general, asset and liability fair values are determined using the following categories: Level 1 – inputs utilize quoted prices in active markets for identical assets or liabilities. Level 2 – inputs include quoted prices for similar assets or liabilities in active markets, and inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. Level 3 – inputs are unobservable inputs and include situations where there is little, if any, market activity for the balance sheet items at period end. Pricing inputs are unobservable for the terms and are based on the Company’s own estimates about the assumptions that a market participant would use in pricing as asset. The Company’s financial instruments, including money market investments, reverse repurchase agreements, corporate debt securities, U.S. Treasury securities and obligations of U.S. government agencies, are measured at fair value on a recurring basis. There were no transfers between levels for the years ended December 31, 2016 and 2015. Assets and liabilities measured at fair value on a recurring basis consisted of the following types of instruments as of December 31, 2016 and 2015 (in thousands): Quoted prices Quoted prices Quoted prices Quoted prices in active for similar assets in active for similar assets markets for observable in the markets for observable in the December 31, identical assets marketplace December 31, identical assets marketplace Description 2016 (Level 1) (Level 2) 2015 (Level 1) (Level 2) Assets measured at fair value: Money market investments $ $ $ — $ $ $ — U.S. Treasury securities, obligations of U.S. government agencies, corporate debt securities and reverse repurchase agreements — — |
Summary of Significant Accoun23
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant Accounting Policies | |
Schedule of assets measured at fair value on a recurring basis (in thousands) | Quoted prices Quoted prices Quoted prices Quoted prices in active for similar assets in active for similar assets markets for observable in the markets for observable in the December 31, identical assets marketplace December 31, identical assets marketplace Description 2016 (Level 1) (Level 2) 2015 (Level 1) (Level 2) Assets measured at fair value: Money market investments $ $ $ — $ $ $ — U.S. Treasury securities, obligations of U.S. government agencies, corporate debt securities and reverse repurchase agreements — — |
Cash, Cash Equivalents and Ma24
Cash, Cash Equivalents and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Cash, Cash Equivalents and Marketable Securities | |
Schedule of cash, cash equivalents and marketable securities (in thousands) | Gross unrealized Gross unrealized Fair market Amortized Cost gains losses value December 31, 2016 Cash $ $ – $ – $ Money market funds – – Reverse repurchase agreements – – U.S. Treasury securities and obligations of U.S. government agencies Corporate debt securities Total for December 31, 2016 $ $ $ $ December 31, 2015 Cash $ $ – $ – $ Money market funds – – Reverse repurchase agreements – – U.S. Treasury securities and obligations of U.S. government agencies Corporate debt securities Total for December 31, 2015 $ $ $ $ |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property and Equipment | |
Schedule of property and equipment (in thousands) | Estimated Useful Life December 31, (in years) 2016 2015 Lab equipment 5 $ $ Computer equipment and software 3 Leasehold improvements 1 Total Less accumulated depreciation Property and equipment, net $ $ |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies | |
Schedule of future minimum payments under lease arrangements (in thousands) | The approximate future minimum payments under these lease arrangements as of December 31, 2016, are as follows (in thousands): 2017 $ 2018 Total $ |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders' Equity | |
Schedule of common stock reserved for issuance | Options to purchase common stock - issued Options to purchase common stock - unissued Inducement grants - issued Employee stock purchase plan - unissued Warrants to purchase common stock Total |
Schedule of options valuation assumptions | 2016 2015 Estimated dividend yield – – Weighted-average expected stock price volatility % % Weighted-average risk-free interest rate % % Weighted-average expected life of option (in years) Weighted-average fair value per option $ $ |
Schedule of stock option activity | Weighted - Average Remaining Weighted Contractual Aggregate Options Average Life Intrinsic Outstanding Exercise Price (in Years) Value Balance as of December 31, 2015 $ Granted Exercised Forfeited Canceled or Expired Balance as of December 31, 2016 $ – Exercisable at December 31, 2016 – Options expected to vest, net of estimated forfeitures $ $ – |
Schedule of non-vested RSUs | Weighted Number of Average RSUs Grant Date Fair Value Unvested as of December 31, 2015 – $ - Granted Vested Unvested as of December 31, 2016 $ |
Schedule of Purchase Plan valuation assumptions | 2016 2015 Estimated dividend yield – – Expected stock price volatility % % Risk-free interest rate % % Expected life of option (in years) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Taxes | |
Schedule of significant components of deferred tax assets and liabilities (in thousands) | 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Income tax credit carryforwards Accrued benefits and other Stock-based compensation – Property and equipment – Intangible assets Valuation allowance Net deferred tax assets – Deferred tax liabilities: Property and equipment – $ – $ – |
Schedule of difference between actual income tax rates and the statutory federal income tax rate | 2016 2015 2014 % of Pretax % of Pretax % of Pretax Earnings Earnings Earnings Income tax benefit at statutory rate % % % State income taxes, net of federal tax benefit % % % Income tax credits % % % Nondeductible expenses and other % % % Change in valuation allowance % % % Income tax expense (benefit) % % % |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Net Loss per Share | |
Schedule of anti-dilutive common stock equivalents | December 31, 2016 2015 2014 Options to purchase common stock - issued Inducement grants - issued — — Unvested restricted common stock — Convertible preferred stock — — Warrants to purchase convertible preferred and common stock Total |
Quarterly Financial Data (Una30
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Data | |
Schedule of results of operations on a quarterly basis (in thousands, except share and per share amounts) | The results of operations on a quarterly basis for the years ended December 31, 2016 and 2015 were as follows (in thousands, except per share data): March 31, June 30, September 30, December 31, March 31, June 30, September 30, December 31, 2016 2016 2016 2016 2015 2015 2015 2015 Revenue $ — $ — $ — $ — $ — $ — $ — $ — Operating expenses: Research and development General and administrative Loss from operations Interest and other income, net — Interest expense — — — — — — — — Net loss $ $ $ $ $ $ $ $ Weighted average shares outstanding - basic and diluted Net loss per share - basic and diluted $ $ $ $ $ $ $ $ |
Liquidity Risks (Details)
Liquidity Risks (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2017employee | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Concentration Risk [Line Items] | ||||
Accumulated deficit | $ 180,300 | $ 148,837 | ||
Net loss | 31,483 | 22,815 | $ 14,658 | |
Cash used in operating activities | 26,259 | $ 19,207 | $ 14,448 | |
Revenues | $ 0 | |||
Subsequent Event | ||||
Concentration Risk [Line Items] | ||||
Workforce reduction, positions | employee | 25 | |||
Workforce reduction, remaining positions | employee | 5 |
Summary of Significant Accoun32
Summary of Significant Accounting Policies (Details) - $ / shares | 36 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Significant Accounting Policies | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Maximum | Vendor concentration risk | ||
Significant Accounting Policies | ||
Concentration risk (as a percent) | 10.00% |
Summary of Significant Accoun33
Summary of Significant Accounting Policies (Fair Value) (Details) - USD ($) | Sep. 23, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Fair Value Measurements | |||||
Fair value measurements, transfers between levels, amount | $ 0 | $ 0 | |||
Assets measured at fair value: | |||||
Fair market value | 61,035,000 | 87,254,000 | |||
Preferred stock warrant liabilities | |||||
Fair Value Measurements | |||||
Warrant fair value | $ 267,750 | ||||
Remeasurement gain | $ 265,750 | ||||
Reclass from liability to equity | $ 2,000 | ||||
Money market funds | |||||
Assets measured at fair value: | |||||
Fair market value | 14,186,000 | 12,131,000 | |||
Money market funds | Recurring | |||||
Assets measured at fair value: | |||||
Fair market value | 14,186,000 | 12,131,000 | |||
Money market funds | Recurring | Level 1 | |||||
Assets measured at fair value: | |||||
Fair market value | 14,186,000 | 12,131,000 | |||
U.S. Treasury securities, obligations of U.S. government agencies, corporate debt securities and reverse repurchase agreements | Recurring | |||||
Assets measured at fair value: | |||||
Fair market value | 41,832,000 | 73,261,000 | |||
U.S. Treasury securities, obligations of U.S. government agencies, corporate debt securities and reverse repurchase agreements | Recurring | Level 2 | |||||
Assets measured at fair value: | |||||
Fair market value | $ 41,832,000 | $ 73,261,000 |
Cash, Cash Equivalents and Ma34
Cash, Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Summary of cash, cash equivalents and marketable securities | ||
Amortized Cost | $ 61,052 | $ 87,251 |
Gross unrealized gains | 2 | 26 |
Gross unrealized losses | (19) | (23) |
Fair market value | 61,035 | 87,254 |
Cash | ||
Summary of cash, cash equivalents and marketable securities | ||
Amortized Cost | 5,017 | 1,862 |
Fair market value | 5,017 | 1,862 |
Money market funds | ||
Summary of cash, cash equivalents and marketable securities | ||
Amortized Cost | 14,186 | 12,131 |
Fair market value | 14,186 | 12,131 |
Reverse repurchase agreements | ||
Summary of cash, cash equivalents and marketable securities | ||
Amortized Cost | 5,000 | 6,000 |
Fair market value | 5,000 | 6,000 |
U.S. Treasury securities and obligations of U.S. government agencies | ||
Summary of cash, cash equivalents and marketable securities | ||
Amortized Cost | 16,458 | 28,982 |
Gross unrealized gains | 1 | 4 |
Gross unrealized losses | (2) | (7) |
Fair market value | 16,457 | 28,979 |
Corporate debt securities | ||
Summary of cash, cash equivalents and marketable securities | ||
Amortized Cost | 20,391 | 38,276 |
Gross unrealized gains | 1 | 22 |
Gross unrealized losses | (17) | (16) |
Fair market value | $ 20,375 | $ 38,282 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property and Equipment | |||
Property and equipment, gross | $ 1,744 | $ 1,669 | |
Less accumulated depreciation | (1,569) | (1,456) | |
Property and equipment, net | 175 | 213 | |
Depreciation expenses | $ 143 | 66 | $ 88 |
Lab equipment | |||
Property and Equipment | |||
Estimated Useful Life (in years) | 5 years | ||
Property and equipment, gross | $ 1,145 | 1,146 | |
Computer equipment and software | |||
Property and Equipment | |||
Estimated Useful Life (in years) | 3 years | ||
Property and equipment, gross | $ 456 | 421 | |
Leasehold improvements | |||
Property and Equipment | |||
Estimated Useful Life (in years) | 1 year | ||
Property and equipment, gross | $ 143 | $ 102 |
Notes Payable (Details)
Notes Payable (Details) | Sep. 23, 2014USD ($)security$ / shares | Sep. 30, 2014USD ($)item | Dec. 31, 2016USD ($) |
Notes Payable | |||
Debt outstanding | $ 0 | ||
2014 Notes | |||
Notes Payable | |||
Number of investors | item | 2 | ||
Debt issued | $ 12,000,000 | ||
Interest rate (as a percent) | 8.00% | ||
Percentage of new series conversion price | 75.00% | ||
Debt and related interest | $ 12,373,741 | ||
Gain on extinguishment recognized through equity | $ 378,251 | ||
2014 Notes | Preferred Stock | Series 1 Convertible Preferred Stock | |||
Notes Payable | |||
Conversion of debt to preferred stock (in shares) | security | 8,813,203 | ||
Conversion price (in dollars per share) | $ / shares | $ 1.40 |
Commitments and Contingencies37
Commitments and Contingencies (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating lease | |||
2,017 | $ 295,000 | ||
2,018 | 80,000 | ||
Total | 375,000 | ||
Rent expense | 279,000 | $ 267,000 | $ 225,000 |
Purchase commitment obligation | $ 1,700,000 | ||
Office and laboratory space | |||
Operating lease | |||
Operating lease renewal term (in years) | 3 years | ||
Termination fees | $ 25,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | Jul. 05, 2016USD ($) | Apr. 18, 2016shares | Jun. 22, 2015USD ($)$ / sharesshares | Sep. 23, 2014 | Dec. 31, 2014USD ($) | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($)item |
Stockholders' Equity | ||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | ||||||
Authorized preferred stock (in shares) | 10,000,000 | 10,000,000 | ||||||
Proceeds from issuance of convertible preferred stock | $ | $ 29,935,000 | |||||||
Convertible preferred stock outstanding (in shares) | 0 | 0 | ||||||
Stock issued upon conversion (in shares) | 6,915,525 | |||||||
Aggregate gross proceeds from issuance of common stock, net of offering costs | $ | $ 88,600,000 | |||||||
Proceeds from issuance of common stock, net of offering costs | $ | 78,800,000 | |||||||
Issuance of common stock, costs | $ | 3,600,000 | $ 9,800,000 | ||||||
Underwriters’ discounts and commissions | $ | $ 6,200,000 | |||||||
Shares issued | 15,565,973 | 15,462,030 | ||||||
IPO | ||||||||
Stockholders' Equity | ||||||||
Issuance of common stock, net of costs (in shares) | 6,325,000 | |||||||
Price per share (in dollars per share) | $ / shares | $ 14 | |||||||
Underwriters' Over-Allotment Option | ||||||||
Stockholders' Equity | ||||||||
Issuance of common stock, net of costs (in shares) | 875,000 | |||||||
Convertible preferred stock | ||||||||
Stockholders' Equity | ||||||||
Number of series of outstanding stock | item | 6 | |||||||
Preferred stock conversion ratio | 11.556 | |||||||
Convertible preferred stock outstanding (in shares) | 19,978,986 | |||||||
Series 2 Convertible Preferred Stock | ||||||||
Stockholders' Equity | ||||||||
Proceeds from issuance of convertible preferred stock | $ | $ 31,000,000 | |||||||
Chief Medical Officer | Options to purchase common stock | ||||||||
Stockholders' Equity | ||||||||
Additional number of shares authorized (in shares) | 108,333 | |||||||
Chief Medical Officer | Restricted stock units ("RSUs") | ||||||||
Stockholders' Equity | ||||||||
Additional number of shares authorized (in shares) | 216,667 | |||||||
Base Prospectus | ||||||||
Stockholders' Equity | ||||||||
Securities registration, maximum potential aggregate offering price | $ | $ 125,000,000 | |||||||
Sales Agreement Prospectus | ||||||||
Stockholders' Equity | ||||||||
Shares issued | 20,000 | |||||||
Sales price (in dollars per share) | $ / shares | $ 8 | |||||||
Offering costs | $ | $ 140,000 | |||||||
Common Stock | ||||||||
Stockholders' Equity | ||||||||
Issuance of common stock, net of costs (in shares) | 20,000 | 6,325,000 | ||||||
Common Stock | Base Prospectus | ||||||||
Stockholders' Equity | ||||||||
Maximum potential shares issued and sold under sales agreement | $ | 3,732,412 | |||||||
Common Stock | Sales Agreement Prospectus | ||||||||
Stockholders' Equity | ||||||||
Securities registration, maximum potential aggregate offering price | $ | $ 20,000,000 |
Stockholders' Equity (Reserved)
Stockholders' Equity (Reserved) (Details) | Dec. 31, 2016shares |
Stockholders' Equity | |
Common stock reserved for issuance | 3,637,116 |
Options to purchase common stock - issued | |
Stockholders' Equity | |
Common stock reserved for issuance | 2,756,921 |
Options to purchase common stock - unissued | |
Stockholders' Equity | |
Common stock reserved for issuance | 391,927 |
Inducement grants - issued | |
Stockholders' Equity | |
Common stock reserved for issuance | 288,889 |
Employee stock purchase plan - unissued | |
Stockholders' Equity | |
Common stock reserved for issuance | 180,845 |
Warrants to purchase common stock | |
Stockholders' Equity | |
Common stock reserved for issuance | 18,534 |
Stockholders' Equity (Assumptio
Stockholders' Equity (Assumptions) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Options to purchase common stock | |||
Fair value assumptions | |||
Weighted-average expected stock price volatility (as a percent) | 79.10% | 75.70% | |
Weighted-average risk-free interest rate (as a percent) | 1.50% | 1.80% | |
Weighted-average expected life of option (in years) | 6 years 2 months 12 days | 6 years 2 months 19 days | |
Weighted-average fair value per option (in dollars per share) | $ 5.09 | $ 5.09 | |
Options granted (in shares) | 1,101,958 | 0 | |
The Purchase Plan | |||
Fair value assumptions | |||
Estimated dividend yield (as a percent) | 0.00% | 0.00% | |
Weighted-average expected stock price volatility (as a percent) | 66.40% | 62.50% | |
Weighted-average risk-free interest rate (as a percent) | 0.40% | 0.10% | |
Weighted-average expected life of option (in years) | 6 months | 6 months |
Stockholders' Equity (OptionAct
Stockholders' Equity (OptionActivity) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2014 | |
Weighted-Average Remaining Contractual Life (In Years) | ||
Outstanding (in years) | 8 years 9 months 4 days | |
Exercisable (in years) | 8 years 1 month 6 days | |
Options expected to vest, net of estimated forfeitures (in years) | 8 years 8 months 27 days | |
Options to purchase common stock | ||
Options Outstanding | ||
Balance (in shares) | 1,787,864 | |
Granted (in shares) | 1,101,958 | 0 |
Exercised (in shares) | (5,722) | |
Forfeited (in shares) | (33,488) | |
Canceled or Expired (in shares) | (7,649) | |
Balance (in shares) | 2,842,963 | |
Exercisable (in shares) | 821,934 | |
Options expected to vest, net of estimated forfeitures (in shares) | 2,723,085 | |
Weighted Average Exercise Price | ||
Balance (in dollars per share) | $ 7.54 | |
Granted (in dollars per share) | 7.37 | |
Exercised (in dollars per share) | 4.52 | |
Forfeited (in dollars per share) | 12.81 | |
Canceled or Expired (in dollars per share) | 16.20 | |
Balance (in dollars per share) | 7.39 | |
Exercisable (in dollars per share) | 6.80 | |
Options expected to vest, net of estimated forfeitures (in dollars per share) | $ 7.36 |
Stockholders' Equity (RSUs) (De
Stockholders' Equity (RSUs) (Details) - Restricted stock units ("RSUs") | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Number of RSUs | |
Unnvested (in shares) | shares | |
Granted (in shares) | shares | 216,667 |
Vested (in shares) | shares | (36,111) |
Unnvested (in shares) | shares | 180,556 |
Weighted Average Grant-Date Fair Value | |
Nonvested (in dollars per share) | $ / shares | |
Granted (in dollars per share) | $ / shares | 4.68 |
Vested (in dollars per share) | $ / shares | 4.68 |
Nonvested (in dollars per share) | $ / shares | $ 4.68 |
Stockholders' Equity (Options a
Stockholders' Equity (Options and ESPP) (Details) - USD ($) | Jan. 01, 2016 | Dec. 12, 2014 | Nov. 17, 2014 | May 31, 2015 | Mar. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Aug. 31, 2012 |
2012 Plan | |||||||||
Share-based compensation | |||||||||
Number of shares authorized (in shares) | 1,289,371 | 147,109 | |||||||
Additional number of shares authorized (in shares) | 519,210 | 623,052 | |||||||
2015 Plan | |||||||||
Share-based compensation | |||||||||
Number of shares authorized (in shares) | 1,081,700 | ||||||||
Additional number of shares authorized (in shares) | 773,102 | ||||||||
Annual percentage increase, authorized shares (as a percent) | 5.00% | ||||||||
The Purchase Plan | |||||||||
Share-based compensation | |||||||||
Number of shares authorized (in shares) | 231,800 | 180,845 | |||||||
Employee stock-based compensation expense | $ 73,000 | $ 22,000 | |||||||
Offering period | 6 months | 6 months | |||||||
Highest percentage of compensation employees may utilize for purchase of common stock (as a percent) | 15.00% | ||||||||
Purchase price relative to fair value (as a percent) | 85.00% | ||||||||
Shares sold to employees (in shares) | 42,031 | 8,924 | |||||||
Weighted-average grant date fair value (in dollars per share) | $ 1.98 | $ 5.18 | |||||||
Share-based compensation expense | $ 73,000 | $ 22,000 | |||||||
Options to purchase common stock | |||||||||
Share-based compensation | |||||||||
Options granted (in shares) | 1,101,958 | 0 | |||||||
Options exercised (in shares) | 5,722 | ||||||||
Employee stock-based compensation expense | $ 3,300,000 | 1,300,000 | $ 70,000 | ||||||
Unrecognized compensation cost related to nonvested stock options | 10,000,000 | ||||||||
Share-based compensation expense | $ 3,300,000 | $ 1,300,000 | $ 70,000 | ||||||
Options to purchase common stock | 2012 Plan | |||||||||
Share-based compensation | |||||||||
Options granted (in shares) | 1,288,174 | ||||||||
Options exercised (in shares) | 685 | ||||||||
Shares terminated (in shares) | 512 | ||||||||
Options to purchase common stock | 2015 Plan | |||||||||
Share-based compensation | |||||||||
Term (in years) | 10 years | ||||||||
Options to purchase common stock | 2015 Plan | Director | Minimum | |||||||||
Share-based compensation | |||||||||
Vesting period (in years) | 1 year | ||||||||
Options to purchase common stock | 2015 Plan | Director | Maximum | |||||||||
Share-based compensation | |||||||||
Vesting period (in years) | 3 years | ||||||||
Options to purchase common stock | 2015 Plan | Employee | |||||||||
Share-based compensation | |||||||||
Vesting period (in years) | 4 years | ||||||||
Common Stock | |||||||||
Share-based compensation | |||||||||
Options exercised (in shares) | 1,000 | ||||||||
Scenario, Forecast | Options to purchase common stock | |||||||||
Share-based compensation | |||||||||
Employee stock-based compensation expense | $ 2,300,000 | ||||||||
Share-based compensation expense | $ 2,300,000 |
Income Taxes (DTA and DTL) (Det
Income Taxes (DTA and DTL) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 28,271 | $ 20,280 | |
Income tax credit carryforwards | 9,268 | 1,813 | |
Accrued benefits and other | 613 | 643 | |
Stock-based compensation | 1,221 | ||
Property and equipment | 20 | ||
Intangible assets | 107 | 125 | |
Valuation allowance | (39,500) | (22,858) | |
Net deferred tax assets | 3 | ||
Deferred tax liabilities: | |||
Property and equipment | (3) | ||
Federal | |||
Deferred tax assets: | |||
Provision for income tax | 0 | 0 | $ 0 |
State | |||
Deferred tax assets: | |||
Provision for income tax | $ 0 | $ 0 | $ 0 |
Income Taxes (NOL) (Details)
Income Taxes (NOL) (Details) $ in Millions | Dec. 31, 2016USD ($) |
Federal | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | $ 75.7 |
State | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | $ 83 |
Income Taxes (Credit) (Details)
Income Taxes (Credit) (Details) - Federal $ in Millions | Dec. 31, 2016USD ($) |
Research and development credits | |
Tax credit carryforward | |
Tax credit carryforwards | $ 2 |
Orphan drug credits | |
Tax credit carryforward | |
Tax credit carryforwards | $ 7.3 |
Income Taxes (Rates) (Details)
Income Taxes (Rates) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
% of Pretax Earnings | |||
Income tax benefit at statutory rate (as a percent) | 34.00% | 34.00% | 34.00% |
State income taxes, net of federal tax benefit (as a percent) | 3.10% | 3.10% | 3.10% |
Income tax credits (as a percent) | 23.70% | 2.60% | 3.50% |
Nondeductible expenses and other (as a percent) | (7.90%) | (1.90%) | (1.00%) |
Change in valuation allowance (as a percent) | (52.90%) | (37.80%) | (39.60%) |
Income tax expense (benefit) (as a percent) | 0.00% | 0.00% | 0.00% |
Unrecognized tax benefits | $ 0 | $ 0 |
Employment Benefit Plan (Detail
Employment Benefit Plan (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Employment Benefit Plan | |||
Gross pay contribution maximum (as a percent) | 75.00% | ||
Safe harbor contribution (as a percent) | 3.00% | ||
Company contributions during the period | $ 150,000 | $ 115,000 | $ 129,000 |
Net Loss per Share (Details)
Net Loss per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Net Loss per Share | |||
Antidilutive common stock equivalents | 3,064,344 | 1,829,007 | 7,025,747 |
Options to purchase common stock - issued | |||
Net Loss per Share | |||
Antidilutive common stock equivalents | 2,756,921 | 1,810,155 | 88,346 |
Inducement grants - issued | |||
Net Loss per Share | |||
Antidilutive common stock equivalents | 288,889 | ||
Unvested restricted common stock | |||
Net Loss per Share | |||
Antidilutive common stock equivalents | 318 | 3,342 | |
Convertible preferred stock | |||
Net Loss per Share | |||
Antidilutive common stock equivalents | 6,915,525 | ||
Warrants to purchase common stock | |||
Net Loss per Share | |||
Antidilutive common stock equivalents | 18,534 | 18,534 | 18,534 |
Quarterly Financial Data (Una50
Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Quarterly Financial Data | |||||||||||
Revenue | $ 0 | ||||||||||
Operating expenses: | |||||||||||
Research and development | $ 5,656 | $ 5,669 | $ 6,424 | $ 5,567 | $ 4,293 | $ 4,279 | $ 4,465 | $ 3,017 | 23,316 | $ 16,054 | $ 12,200 |
General and administrative | 2,168 | 1,879 | 2,172 | 2,367 | 2,337 | 1,822 | 1,387 | 1,298 | 8,586 | 6,844 | 2,287 |
Loss from operations | (7,824) | (7,548) | (8,596) | (7,934) | (6,630) | (6,101) | (5,852) | (4,315) | (31,902) | (22,898) | (14,487) |
Interest and other income, net | 111 | 115 | 117 | 96 | 67 | 12 | 1 | 439 | 80 | 296 | |
Interest expense | (845) | ||||||||||
Net loss attributable to common stockholders | $ (7,713) | $ (7,433) | $ (8,479) | $ (7,838) | $ (6,563) | $ (6,089) | $ (5,852) | $ (4,314) | $ (31,463) | $ (22,818) | $ (14,658) |
Weighted average shares outstanding - basic and diluted (in shares) | 15,540 | 15,504 | 15,462 | 15,462 | 15,452 | 15,451 | 4,159 | 2,209 | 15,492 | 9,371 | 723 |
Net loss per share attributable to common stockholders - basic and diluted (in dollars per share) | $ (0.50) | $ (0.48) | $ (0.55) | $ (0.51) | $ (0.42) | $ (0.39) | $ (1.41) | $ (1.95) | $ (2.03) | $ (2.43) | $ (20.27) |
Subsequent Events (Details)
Subsequent Events (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Jan. 31, 2017USD ($)employee | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Workforce reduction, positions | employee | 25 | ||||
Workforce reduction, remaining positions | employee | 5 | ||||
Restructuring, expected cost | $ 3,000,000 | ||||
Employee Severance | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Vesting percentage | 100.00% | ||||
Options to purchase common stock | |||||
Subsequent Event [Line Items] | |||||
Unrecognized compensation cost related to nonvested stock options | $ 10,000,000 | ||||
Employee stock-based compensation expense | $ 3,300,000 | $ 1,300,000 | $ 70,000 | ||
Options to purchase common stock | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Employee stock-based compensation expense | $ 2,300,000 |
Uncategorized Items - nvls-2016
Label | Element | Value |
Series2 Convertible Preferred Stock [Member] | ||
Stock Issued During Period, Value, Conversion of Convertible Securities | us-gaap_StockIssuedDuringPeriodValueConversionOfConvertibleSecurities | $ (29,935,000) |
Stock Issued During Period, Shares, Conversion of Convertible Securities | us-gaap_StockIssuedDuringPeriodSharesConversionOfConvertibleSecurities | (11,166,000) |
Series1 Convertible Preferred Stock [Member] | ||
Stock Issued During Period, Value, Conversion of Convertible Securities | us-gaap_StockIssuedDuringPeriodValueConversionOfConvertibleSecurities | $ (11,945,000) |
Stock Issued During Period, Shares, Conversion of Convertible Securities | us-gaap_StockIssuedDuringPeriodSharesConversionOfConvertibleSecurities | (8,813,000) |