Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 14, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Savara Inc. | ||
Entity Central Index Key | 1,160,308 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Trading Symbol | SVRA | ||
Entity Common Stock, Shares Outstanding | 30,596,741 | ||
Entity Public Float | $ 135,686,539 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 22,121,000 | $ 13,373,000 |
Short-term investments | 72,192,000 | 0 |
Grants and award receivable | 400,000 | |
Prepaid expenses and other current assets | 3,551,000 | 840,000 |
Total current assets | 97,864,000 | 14,613,000 |
Property and equipment, net | 925,000 | 793,000 |
In-process R&D | 33,626,000 | 10,477,000 |
Goodwill | 27,082,000 | 3,051,000 |
Other non-current assets | 131,000 | |
Total assets | 159,628,000 | 28,934,000 |
Current liabilities: | ||
Accounts payable | 2,784,000 | 536,000 |
Accrued expenses | 2,966,000 | 2,477,000 |
Current portion of capital lease obligation | 265,000 | 442,000 |
Total current liabilities | 6,015,000 | 3,455,000 |
Long-term liabilities: | ||
Accrued interest on convertible promissory notes | 151,000 | |
Debt facility | 14,775,000 | |
Convertible promissory notes | 3,448,000 | |
Put option derivative liability | 979,000 | |
Contingent consideration | 11,948,000 | 9,708,000 |
Deferred tax liability | 7,181,000 | 2,305,000 |
Capital lease obligation, net of current portion | 297,000 | 579,000 |
Warrant liability | 303,000 | |
Other long-term liabilities | 103,000 | 20,000 |
Total liabilities | 40,319,000 | 20,948,000 |
Redeemable convertible preferred stock: | ||
Total redeemable convertible preferred stock | 43,861,000 | |
Stockholders’ equity (deficit): | ||
Common stock, $0.001 par value, 500,000,000 and 27,000,000 shares authorized as of December 31, 2017 and 2016, respectively; 30,509,522 and 3,162,573 shares (after giving effect to the Exchange Ratio and Reverse Stock Split) issued and outstanding as of December 31, 2017 and 2016, respectively | 32,000 | 5,000 |
Additional paid-in capital | 186,522,000 | 3,117,000 |
Accumulated other comprehensive income (loss) | 958,000 | (591,000) |
Accumulated deficit | (68,203,000) | (38,406,000) |
Total stockholders’ equity (deficit) | 119,309,000 | (35,875,000) |
Total liabilities, redeemable convertible preferred stock, and stockholder’s equity (deficit) | $ 159,628,000 | 28,934,000 |
Series A Redeemable Convertible Preferred Stock [Member] | ||
Redeemable convertible preferred stock: | ||
Total redeemable convertible preferred stock | 3,232,000 | |
Series B Redeemable Convertible Preferred Stock [Member] | ||
Redeemable convertible preferred stock: | ||
Total redeemable convertible preferred stock | 17,301,000 | |
Series C Redeemable Convertible Preferred Stock [Member] | ||
Redeemable convertible preferred stock: | ||
Total redeemable convertible preferred stock | $ 23,328,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Redeemable convertible preferred stock, shares authorized | 15,799,906 | |
Redeemable convertible preferred stock, shares issued | 11,927,875 | |
Redeemable convertible preferred stock, shares outstanding | 0 | 11,927,875 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 27,000,000 |
Common stock, shares issued | 30,509,522 | 3,162,573 |
Common stock, shares outstanding | 30,509,522 | 3,162,573 |
Series A Redeemable Convertible Preferred Stock [Member] | ||
Redeemable convertible preferred stock, par value | $ 0.001 | $ 0.001 |
Redeemable convertible preferred stock, shares authorized | 0 | 1,799,906 |
Redeemable convertible preferred stock, shares issued | 0 | 1,799,906 |
Redeemable convertible preferred stock, shares outstanding | 0 | 1,799,906 |
Series B Redeemable Convertible Preferred Stock [Member] | ||
Redeemable convertible preferred stock, par value | $ 0.001 | $ 0.001 |
Redeemable convertible preferred stock, shares authorized | 0 | 6,000,000 |
Redeemable convertible preferred stock, shares issued | 0 | 5,675,387 |
Redeemable convertible preferred stock, shares outstanding | 0 | 5,675,387 |
Series C Redeemable Convertible Preferred Stock [Member] | ||
Redeemable convertible preferred stock, par value | $ 0.001 | $ 0.001 |
Redeemable convertible preferred stock, shares authorized | 0 | 8,000,000 |
Redeemable convertible preferred stock, shares issued | 0 | 4,452,582 |
Redeemable convertible preferred stock, shares outstanding | 0 | 4,452,582 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | |||
Grant and award revenue | $ 0 | $ 400,000 | $ 54,000 |
Operating expenses: | |||
Research and development | 18,512,000 | 8,182,000 | 4,321,000 |
General and administrative | 11,081,000 | 2,820,000 | 1,650,000 |
Depreciation | 363,000 | 346,000 | 6,000 |
Total operating expenses | 29,956,000 | 11,348,000 | 5,977,000 |
Loss from operations | (29,956,000) | (10,948,000) | (5,923,000) |
Other income (expense): | |||
Interest expense | (1,161,000) | (452,000) | (2,585,000) |
Foreign currency exchange gain (loss) | (218,000) | 76,000 | |
Loss on extinguishment of debt | (1,816,000) | (226,000) | |
Change in fair value of financial instruments | (280,000) | 44,000 | (265,000) |
Total other income (expense) | (3,475,000) | (332,000) | (3,076,000) |
Loss before income taxes | (33,431,000) | (11,280,000) | (8,999,000) |
Income tax benefit | 3,634,000 | 357,000 | |
Net loss | (29,797,000) | (10,923,000) | (8,999,000) |
Accretion of redeemable convertible preferred stock | (578,000) | (94,000) | (183,000) |
Deemed dividend on beneficial conversion feature | (404,000) | ||
Net loss attributable to common stockholders | (30,779,000) | (11,017,000) | (9,182,000) |
Other comprehensive income: | |||
Gain (loss) on foreign currency translation | 1,595,000 | (591,000) | |
Unrealized gain (loss) on short-term investments | (46,000) | ||
Total Comprehensive Loss | $ (28,248,000) | $ (11,514,000) | $ (8,999,000) |
Net loss per share: | |||
Basic and diluted | $ (1.76) | $ (5.62) | $ (9.48) |
Weighted average common shares outstanding | |||
Basic and diluted | 17,521,119 | 1,960,490 | 968,810 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Redeemable Convertible Series A Preferred Stock | Redeemable Convertible Series B Preferred Stock | Redeemable Convertible Series C Preferred Stock | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Beginning balances at Dec. 31, 2014 | $ 20,271 | $ 3,206 | $ 17,065 | |||||
Beginning balance, shares at Dec. 31, 2014 | 1,799,906 | 5,675,387 | ||||||
Accretion of redeemable convertible preferred stock | 183 | $ 24 | $ 159 | |||||
Issuance of redeemable convertible preferred stock | 22,531 | $ 22,531 | ||||||
Issuance of redeemable convertible preferred stock, shares | 4,038,790 | |||||||
Ending balances at Dec. 31, 2015 | 42,985 | $ 3,230 | $ 17,224 | $ 22,531 | ||||
Ending balance, shares at Dec. 31, 2015 | 1,799,906 | 5,675,387 | 4,038,790 | |||||
Beginning balances at Dec. 31, 2014 | (18,299) | $ 2 | $ 183 | $ (18,484) | ||||
Beginning balance, shares at Dec. 31, 2014 | 1,167,049 | |||||||
Issuance of restricted common stock, shares | 29,300 | |||||||
Accretion of redeemable convertible preferred stock | (183) | (183) | ||||||
Stock-based compensation | 153 | 153 | ||||||
Net loss incurred | (8,999) | (8,999) | ||||||
Ending balance at Dec. 31, 2015 | (27,328) | $ 2 | 153 | (27,483) | ||||
Ending balance, shares at Dec. 31, 2015 | 1,196,349 | |||||||
Accretion of redeemable convertible preferred stock | 94 | $ 2 | $ 77 | $ 15 | ||||
Issuance of Series C convertible preferred stock, net | 782 | $ 782 | ||||||
Issuance of Series C convertible preferred stock, shares | 413,792 | |||||||
Ending balances at Dec. 31, 2016 | $ 43,861 | $ 3,232 | $ 17,301 | $ 23,328 | ||||
Ending balance, shares at Dec. 31, 2016 | 11,927,875 | 1,799,906 | 5,675,387 | 4,452,582 | ||||
Accretion of redeemable convertible preferred stock | $ (94) | (94) | ||||||
Issuance of common stock upon exercise of stock options | 1 | 1 | ||||||
Issuance of common stock upon exercise of stock options, shares | 824 | |||||||
Common stock issued for acquistion of Serendex assets and subsidiaries | 2,851 | $ 3 | 2,848 | |||||
Common stock issued for acquistion of Serendex assets and subsidiaries, shares | 1,965,400 | |||||||
Stock-based compensation | 209 | 209 | ||||||
Foreign exchange translation adjustment | (591) | $ (591) | ||||||
Net loss incurred | (10,923) | (10,923) | ||||||
Ending balance at Dec. 31, 2016 | (35,875) | $ 5 | 3,117 | (38,406) | (591) | |||
Ending balance, shares at Dec. 31, 2016 | 3,162,573 | |||||||
Accretion of redeemable convertible preferred stock | 578 | $ 22 | $ 460 | $ 96 | ||||
Temporary equity, Conversion of redeemable convertible preferred stock to common stock as effected for the reverse merger exchange ratio | $ (44,439) | $ (3,254) | $ (17,761) | $ (23,424) | ||||
Temporary equity, Conversion of redeemable convertible preferred stock to common stock as effected for the reverse merger exchange ratio, shares | (1,799,906) | (5,675,387) | (4,452,582) | |||||
Ending balance, shares at Dec. 31, 2017 | 0 | |||||||
Repurchase of forfeited restricted common stock | (19,045) | |||||||
Accretion of redeemable convertible preferred stock | $ (578) | (578) | ||||||
Issuance of common stock upon exercise of stock options | 5 | 5 | ||||||
Issuance of common stock upon exercise of stock options, shares | 2,918 | |||||||
Common stock issued for acquistion of Serendex assets and subsidiaries | 35,846 | $ 4 | 35,842 | |||||
Common stock issued for acquistion of Serendex assets and subsidiaries, shares | 3,639,189 | |||||||
Issuance of common stock upon exercise of warrants | 384 | 384 | ||||||
Issuance of common stock upon exercise of warrants, Shares | 111,799 | |||||||
Conversion of convertible notes into common stock | 10,045 | $ 1 | 10,044 | |||||
Conversion of convertible notes into common stock, Shares | 1,140,046 | |||||||
Conversion of redeemable convertible preferred stock to common stock as effected for the reverse merger exchange ratio | 44,438 | $ 7 | 44,431 | |||||
Conversion of redeemable convertible preferred stock to common stock as effected for the reverse merger exchange ratio, Shares | 7,034,102 | |||||||
Reclassification of warrant liability | 370 | 370 | ||||||
Beneficial conversion feature | 404 | 404 | ||||||
Issuance of common stock upon public offering, net closing costs | 89,598 | $ 15 | 89,583 | |||||
Issuance of common stock upon public offering, net closing costs, shares | 15,071,710 | |||||||
Issuance of detachable warrants with debt instrument | 359 | 359 | ||||||
Issuance of common stock upon At The Market sales, net | 1,665 | 1,665 | ||||||
Issuance of common stock upon At The Market sales, net, shares | 198,298 | |||||||
Issuance of common stock for settlement of RSUs, shares | 75,486 | |||||||
Net issuance of common stock upon cashless exercise of stock options, shares | 92,446 | |||||||
Issuance of call option derivative | 344 | 344 | ||||||
Stock-based compensation | 552 | 552 | ||||||
Foreign exchange translation adjustment | 1,595 | 1,595 | ||||||
Unrealized gain (loss) on short-term investments | (46) | (46) | ||||||
Net loss incurred | (29,797) | (29,797) | ||||||
Ending balance at Dec. 31, 2017 | $ 119,309 | $ 32 | $ 186,522 | $ (68,203) | $ 958 | |||
Ending balance, shares at Dec. 31, 2017 | 30,509,522 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash flows from operating activities: | |||
Net loss | $ (29,797) | $ (10,923) | $ (8,999) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 363 | 346 | 6 |
Changes in fair value of financial instruments | 280 | (228) | 265 |
Change in fair value of contingent consideration | 2,240 | 184 | |
Noncash interest | 336 | 199 | 642 |
Loss on extinguishment of debt | 1,816 | 226 | |
Foreign currency loss | 218 | 76 | |
Accretion on discount to convertible promissory notes | 269 | 1,948 | |
Amortization of debt issuance costs | 401 | ||
Accretion on discount to short-term investments | (136) | ||
Stock-based compensation | 552 | 209 | 153 |
Issuance of call option derivative | 344 | ||
Provision (benefit) for deferred taxes | (2,820) | ||
Changes in operating assets and liabilities: | |||
Grant and award receivable | 400 | (400) | 961 |
Tax refund receivable | (454) | 393 | |
Prepaid expenses and other current assets | (2,110) | (289) | 214 |
Deferred rent | (26) | 14 | 6 |
Accounts payable and accrued expenses | 159 | 1,780 | (200) |
Net cash used in operating activities | (28,234) | (8,370) | (4,778) |
Cash flows from investing activities: | |||
Cash acquired through Merger | 3,442 | ||
Purchase of property and equipment | (495) | (8) | |
Maturities of available-for-sale securities | 4,800 | ||
Purchase of available-for-sale securities | (76,862) | ||
Net cash used in investing activities | (69,115) | (8) | |
Cash flows from financing activity: | |||
Proceeds from debt facility, net | 14,894 | ||
Proceeds from convertible promissory note, net | 3,569 | 4,415 | |
Issuance of common stock upon exercise of warrants | 384 | ||
Issuance of common stock upon public offering, net | 89,598 | ||
Repayment of long-term debt | (3,567) | ||
Issuance of common stock upon at the market offerings, net | 1,666 | ||
Proceeds from exercise of stock options | 5 | 1 | |
Proceeds from issuance of Series C preferred stock, net | 782 | 8,773 | |
Capital lease obligation principal payments | (460) | (81) | |
Net cash provided by financing activities | 106,089 | 5,117 | 8,773 |
Effect of exchange rate changes on cash and cash equivalents | 8 | (49) | |
Increase / (Decrease) in cash and cash equivalents | 8,748 | (3,310) | 3,995 |
Cash and cash equivalents beginning of period | 13,373 | 16,683 | 12,688 |
Cash and cash equivalents end of period | 22,121 | 13,373 | 16,683 |
Non-cash transactions: | |||
Net assets acquired in business combination of Serendex | (12,375) | ||
Equipment under capital lease | (1,102) | ||
Contingent liability related to purchase of Serendex | 9,524 | ||
Extinguishment and derecognition of put options | 2,202 | 2,708 | |
Shares issued in connection of business combination and assumed equity awards | 35,846 | 2,851 | |
Beneficial conversion feature | 404 | ||
Supplemental disclosure of cash flow information: | |||
Cash paid for income taxes | 2 | ||
Common Stock [Member] | |||
Non-cash transactions: | |||
Conversion of convertible notes into stock | 8,249 | ||
Preferred Stock [Member] | |||
Non-cash transactions: | |||
Conversion of convertible notes into stock | 11,006 | ||
Series A Redeemable Convertible Preferred Stock [Member] | |||
Non-cash transactions: | |||
Accretion of redeemable convertible preferred stock | 22 | 2 | 24 |
Series B Redeemable Convertible Preferred Stock [Member] | |||
Non-cash transactions: | |||
Accretion of redeemable convertible preferred stock | 460 | 77 | $ 159 |
Series C Redeemable Convertible Preferred Stock [Member] | |||
Non-cash transactions: | |||
Accretion of redeemable convertible preferred stock | $ 96 | $ 15 |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business Savara Inc. (“Savara,” the “Company,” or as used in the context of “we” or “us”) is an orphan lung disease company. The Company’s pipeline comprises: Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF, in Phase 3 development for pulmonary alveolar proteinosis (“PAP”) and in Phase 2a development for nontuberculous mycobacterial (“NTM”) lung infection; and AeroVanc, a Phase 3 stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (“MRSA”), infection in cystic fibrosis (“CF”). As part of the Merger, described herein, the Company acquired an ancillary product candidate, Aironite, an inhaled sodium nitrite for heart failure with preserved ejection fraction (“HFpEF”) in Phase 2 development. The Company and its wholly owned subsidiaries, including Aravas Inc. and Savara ApS, operate in one segment with its principal offices in Austin, Texas. On April 27, 2017, Savara completed its business combination with Mast Therapeutics, Inc. ("Mast"), a publicly held company, in accordance with the terms of the Agreement and Plan of Merger and Reorganization (the "Merger Agreement"), dated January 6, 2017 (the "Merger"). In connection with and immediately prior to the effective time of the Merger, Mast implemented a reverse stock split at a ratio of one new share for every 70 shares of its common stock outstanding (the “Reverse Stock Split”). Under the terms of the Merger Agreement, each outstanding share of Savara common stock was then converted into Mast common stock at a ratio of approximately .5860 of a Savara share (the “Exchange Ratio”). Immediately following the effective date of the Merger, Mast’s preexisting equity holders owned approximately 23% of the combined company, and Savara’s preexisting equity holders owned approximately 77%. Accordingly, all operations presented in the accompanying financial statements and notes to the financial statements represent the historical activity of Savara, the private company prior to the Merger. The accompanying consolidated financial statements and notes to the consolidated financial statements also give retroactive effect to the common stock Exchange Ratio and Reverse Stock Split for all periods presented, including common stock warrants and common stock-based compensation awards. Following the Merger, Mast was renamed “Savara Inc." and its common stock is trading on The Nasdaq Global Select Market under the symbol "SVRA." Prior to the Merger, Mast’s common stock was traded on the New York Stock Exchange under the symbol "MSTX." The combined company’s product pipeline includes: • Molgradex • AeroVanc Since inception, Savara has devoted substantially all of its efforts and resources to identifying and developing its product candidates, recruiting personnel, and raising capital. Savara has incurred operating losses and negative cash flow from operations and has no product revenue from inception to date. The Company has not yet commenced commercial operations. Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (“FASB”). Certain prior year amounts have been reclassified for consistency with the current period presentation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Liquidity As of December 31, 2017, the Company had an accumulated deficit of approximately $68.2 million. The Company also used cash from operations of approximately $28.2 million for the year ended December 31, 2017. The cost to further develop and obtain regulatory approval for any drug is substantial and, as noted below, the Company may have to take certain steps to maintain a positive cash position. Accordingly, the Company will need additional capital to further fund the development of, and seek regulatory approvals for, its product candidates and begin to commercialize any approved products. The Company is currently focused primarily on the development of respiratory drugs and believes such activities will result in the Company’s continued incurrence of significant research and development and other expenses related to those programs. If the clinical trials for any of the Company’s product candidates fail or produce unsuccessful results and those product candidates do not gain regulatory approval, or if any of the Company’s product candidates, if approved, fail to achieve market acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expenses through cash and cash equivalents on hand and through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. While the Company had cash and cash equivalents of $22.1 million and short-term investments of $72.2 million as of December 31, 2017, we intend to continue to raise additional capital as needed through the issuance of additional equity and potentially through borrowings, and strategic alliances with partner companies. However, if such financings are not available timely and at adequate levels, the Company will need to reevaluate its operating plans. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars and are prepared using U.S. GAAP. These financial statements include the accounts of the Company and its wholly owned subsidiaries. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Income. All intercompany transactions and accounts have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development costs, the valuation of preferred and common shares, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates. Risks and Uncertainties The product candidates being developed by the Company require approvals from the U.S. Food and Drug Administration (FDA) or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company’s product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. Cash and Cash Equivalents Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value. Grants and Award Receivables Receivables arise from incurring allowable costs under federal grants or through the achievement of milestones under an award from a non-profit organization that have not been received as of the balance sheet dates. Since inception, the Company has never incurred losses on its grants and award receivable. The Company has no allowance for doubtful accounts as of December 31, 2016 as grants recievable were collected in full in 2017. No grant revenue or grants receivable were recognized in 2017. As such, the Company has no allowance for doubtful accounts as of December 31, 2017. Short-term Investments The Company has classified its investments in debt securities and equity securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments, net of taxes, reflected as a part of “Accumulated other comprehensive income (loss)” within stockholders' equity. The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Investments in debt securities are considered to be impaired when a decline in fair value is judged to be other than temporary because the Company either intends to sell or it is more-likely-than not that it will have to sell the impaired security before recovery. Once a decline in fair value is determined to be other than temporary, an impairment charge is recorded and a new cost basis in the investment is established. Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents and foreign exchange derivatives not designated as hedging. The Company places its cash and cash equivalents with a limited number of high quality financial institutions and at times may exceed the amount of insurance provided on such deposits. Accrued Research and Development Costs The Company records the costs associated with research nonclinical studies, clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third-party service providers, including contract research and manufacturing organizations. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the study duration, may vary from the Company’s estimates resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. The Company has not experienced any material deviations between accrued and actual research and development expenses. Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of purchase price over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on all available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. Goodwill and Acquired In-Process Research and Development (IPR&D) Goodwill and acquired IPR&D are not amortized but are tested annually for impairment or more frequently if impairment indicators exist. The Company adopted accounting guidance related to annual and interim goodwill and acquired IPR&D impairment tests which allows the Company to first assess qualitative factors before performing a quantitative assessment of the fair value of a reporting unit. If it is determined on the basis of qualitative factors that the fair value of the reporting unit is more likely than not less than the carrying amount, a quantitative impairment test is required. During the year ended December 31, 2017, the Company experienced a $0.4 million and $1.5 million increase in the carrying value of goodwill and IPR&D, respectively, related to its acquisition of Savara ApS, which was due to foreign currency translation. Additional goodwill and IPR&D were recorded with respect to the Merger. Tax Refund Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, for the post-acquisition period in 2016 and year ended December 31, 2017. Under Danish Tax Law, Denmark remits a research and development tax credit equal to 22% of qualified research and development expenditures, not to exceed established thresholds and offsets future taxable income. As of December 31, 2017, credits totaling $0.8 million is not due to be received until November 2018. The portion of the total Danish tax credit related to the post-acquisition period in 2016 of approximately $0.4 million was collected in November 2017. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. Our chief operating decision maker is the chief executive officer. We have one operating segment, specialty pharmaceuticals within the respiratory system. Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: • Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. Financial instruments carried at fair value include cash and cash equivalents and contingent consideration related to the acquisition of Serendex for which any change is reflected in general and administrative expense, foreign exchange derivatives, and certain warrants classified as liabilities and embedded put options separated from the convertible promissory notes which were converted to common equity or derecognized on April 27, 2017 as a result of the Merger (Notes 8 and 10). Financial instruments not carried at fair value include accounts payable and accrued liabilities. The carrying amounts of these financial instruments approximate fair value due to the highly liquid nature of these short-term instruments. Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which range from three to five years. Repairs and maintenance that do not improve or extend the useful life of the respective asset are charged to expense as incurred. Equipment under Capital Lease In 2015, the Company entered into a contract manufacturing arrangement that included the right to use specified equipment. Management concluded that the contract manufacturing arrangement contains an embedded lease of the specified equipment based on the facts and circumstances, including the Company’s ability to direct the use of the equipment and because management believes that it is remote that any party other than the Company will take more than a minor output produced by the equipment during the term of the arrangement. Management performed an analysis under ASC 840 to determine the proper accounting for the embedded lease and concluded that there is a capital lease because the present value of the minimum lease payments per the contract exceeds 90% of the fair value of the equipment. The capitalized equipment is depreciated on a straight-line basis over the lesser of the non-cancellable lease term or the useful life, and the lease obligation accrues interest at the incremental rate used in the present value analysis. Convertible Debt Issuance Costs Convertible debt issuance costs are presented on the balance sheets as a direct deduction from the carrying amount of the debt liability. Convertible debt issuance costs incurred in the years ended December 31, 2017 and 2016 were not material. Patents and Intellectual Property The Company currently expenses all patent application costs. As the Company’s products are currently under research and development and are not currently approved for market, costs incurred in connection with patent applications are expensed as incurred due to the uncertainty of the future economic benefits of the underlying patents and intellectual property. Revenue Recognition To date, the Company has recognized revenue solely from federal grants under the Small Business Innovation Research Program of the Department of Health and Human Services, National Institutes of Health (“NIH”, together the “Federal Grants”) and an award from the Cystic Fibrosis Foundation Therapeutics, Inc. (the “CFFT”), a non-profit organization (the “CFF Award”) as further described in Note 13. The Company has not generated any product revenue to date. The Company’s ability to generate product revenues, which the Company does not expect will occur for many years, if ever, will depend heavily on the successful development, regulatory approval and eventual commercialization of the Company’s product candidates. The Company records revenue related to the Federal Grants as qualifying costs are incurred, and when there is reasonable assurance that the conditions of the grant have been met and the grant will be received. The Company records revenue related to the CFF Award upon completion and achievement of defined milestones, and when there is reasonable assurance that the conditions of the award have been met and collectability is reasonably assured. Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. Redeemable Convertible Preferred Stock and Series B and Series C Warrants The Series A, Series B, and Series C redeemable convertible preferred stock, previously classified in temporary equity as it was redeemable at the written request of the holders of at least two-thirds of the then outstanding shares of preferred stock, at any time after October 31, 2022, was converted to common stock on the effective date of the Merger subject to the Exchange Ratio. Additionally, certain outstanding warrants to purchase Series B convertible preferred stock (“Series B Warrants”) previously classified as liabilities were exercised on the effective date of the Merger with any residual Series B warrants expiring in May 2017. Certain outstanding warrants to purchase Series C redeemable convertible preferred stock (“Series C Warrants”) were reclassified from a liability to common equity as the Series C Warrants have been converted to warrants to purchase common stock subject to the Exchange Ratio following the Merger. Stock-Based Compensation The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period (see Note 16). Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. The Company recognizes the cost of stock-based awards granted to nonemployees at their then-current fair values as services are performed, and such awards are remeasured through the counterparty performance date. Manufacturing Commitments and Contingencies The Company is subject to various manufacturing royalties and payments related to its product candidate, Molgradex. Under an agreement, as amended, with the Active Pharmaceutical Ingredients (“API”) manufacturer, no signing fee or milestones are included in the royalty payments, and there is no minimum royalty. Upon the successful development, registration and attainment of approval by the proper health authorities, such as the FDA, in any territory except Latin America, Central America and Mexico, the Company must pay a royalty of three percent (3%) on annual net sales to the manufacturer of its API. Additionally, Savara must make certain payments to the API manufacturer upon the achievement of the milestones outlined in the following table. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the Company’s manufacturer of its nebulizer used to administer Molgradex. In addition to these milestones, the Company will owe a royalty to the manufacturer of its nebulizer based on net sales. The royalty rate ranges from three and a half percent (3.5%) to five percent (5%) depending on the device technology used by the Company to administer the product. Manufacturing Contingent Milestone Payments (in thousands) : December 31, 2017 Molgradex API manufacturer: Delivery of working and master cell banks $ 600 Achievement of certain milestones related to regulatory approval of Molgradex 2,000 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 8,330 Total manufacturing commitments $ 10,930 As of December 31, 2017 and 2016, none of the above milestones had been met. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more likely than not to be realized. Recent Accounting Pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers and has subsequently issued several supplemental and/or clarifying ASUs, which comprise the new comprehensive revenue recognition standard that will replace all current GAAP guidance on this topic and eliminate all industry-specific guidance. The standard’s core principle is that a reporting entity will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. We have performed an assessment of our contracts with third parties and determined that they would not have a material impact on our financial statements. In February 2016, the FASB issued Accounting Standards Update 2016-02, “Leases” (“ASU 2016-02”). The update aims at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet as a right-of-use asset and a corresponding lease liability, including leases currently accounted for as operating leases. The update also requires improved disclosures to help users of financial statements better understand the amount, timing and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 with early adoption permitted. The Company is currently evaluating the impact of the adoption of ASU 2016-02 on its financial statements. In August 2016, the FASB issued Accounting Standards Update 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”), which intended to add or clarify guidance on the classification of certain cash receipts and payments on the statement of cash flows. The new guidance addresses cash flows related to the following: debt prepayment or extinguishment costs, settlement of zero coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies and bank-owned life insurance policies, distributions received from equity method investees, beneficial interest in securitization transactions, and the application of predominance principle to separately identifiable cash flows. ASU 2016-15 is effective for the Company for annual periods beginning after December 15, 2017 with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its financial statements. In January 2017, the FASB issued Accounting Standards Update 2017-01, “Business Combinations (Topic 805): Clarifying the Definition of a Business” (“ASU 2017-01”), which intended to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. ASU 2017-01 is effective for the Company for annual periods beginning after December 15, 2017 with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2017 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 3. Prepaid expenses and other current assets Prepaid expenses, consisted of (in thousands): December 31, 2017 2016 R&D tax credit receivable $ 834 $ 357 Prepaid clinical trial costs 2,129 243 VAT receivable 196 111 Prepaid insurance 158 35 Forward currency exchange derivative 40 — Deposits and other 194 94 Total prepaid expenses and other current assets $ 3,551 $ 840 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | 4. Accrued expenses and other liabilities Accrued expenses and other liabilities, consisted of (in thousands): December 31, 2017 2016 Accrued contracted research and development costs $ 1,308 $ 1,855 Accrued general and administrative costs 323 458 Accrued compensation 1,328 117 Other 7 47 Total accrued expenses and other liabilities $ 2,966 $ 2,477 |
Short-term Investments
Short-term Investments | 12 Months Ended |
Dec. 31, 2017 | |
Investments Debt And Equity Securities [Abstract] | |
Short-term Investments | 5. Short-term Investments Short-term Investments in Available for Sale Securities The Company’s investment policy seeks to preserve capital and maintain sufficient liquidity to meet operational and other needs of the business. The following table summarizes, by major security type, the Company’s investments as of December 31, 2017 (in thousands): Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 11,894 $ — $ (9 ) $ 11,885 Asset backed securities 8,389 — (6 ) 8,383 Corporate securities 22,113 — (31 ) 22,082 Commercial paper 29,842 — — 29,842 Total short-term investments $ 72,238 $ — $ (46 ) $ 72,192 The Company has classified its investments as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments, net of taxes, reflected as a part of “Accumulated other comprehensive income (loss)” in the Consolidated Balance Sheets. Classification as short-term or long-term is based upon the maturity of the debt securities, which is less than twelve months. There were no significant realized gains or losses related to investments for the years ended December 31, 2017, 2016, and 2015. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment, net consisted of (in thousands): 2017 2016 Research and development equipment under capital lease $ 1,102 $ 1,102 Equipment 674 177 Furniture and fixtures — 18 Total property and equipment 1,776 1,297 Less accumulated depreciation (851 ) (504 ) Property and equipment, net 925 793 Depreciation expense for the years ended December 31, 2017, 2016, and 2015 was $0.4 million, $0.3, million, and six thousand dollars, respectively, and includes the amortization of the capital lease. The amount of accumulated amortization of capitalized leases as of December 31, 2017 was $0.7 million. |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2017 | |
Business Combinations [Abstract] | |
Acquisitions | 7. Acquisitions (a) Mast On April 27, 2017, the Company completed the Merger with Mast as discussed in Note 1. The Merger was accounted for as a reverse merger under the acquisition method of accounting whereby Savara was considered to have acquired Mast for financial reporting purposes because, immediately upon completion of the Merger, Savara stockholders held a majority of the voting interest of the combined company. Pursuant to business combination accounting, the Company applied the acquisition method, which requires the assets acquired and liabilities assumed be recorded at fair value with limited exceptions. The Company used the Multi-Period Excess Earnings Model (MPEEM), a form of the income approach to value the in-process research and development intangible asset. Under the valuation method, the present value of future cash flows expected to be generated from the in-process research and development of the acquired product candidate, Aironite, was determined using a reasonable discount rate, and identified projected cash flows from Aironite were risk adjusted to take into consideration the probabilities of moving through the various clinical stages. The excess of the purchase price over the assets acquired and liabilities assumed represents goodwill. The goodwill is primarily attributable to the synergies expected to arise after the acquisition and is not expected to be deductible for tax purposes. Transaction costs associated with the Merger of approximately $2.2 million are included in general and administrative expense for the year ended December 31, 2017. The total purchase price for Mast was $35.8 million based on the fair value of the outstanding Mast equity on the date of the Merger which was allocated as follows: Purchase Consideration (in thousands) Fair value of Mast shares outstanding $ 33,117 Fair value of Mast equity 2,729 Fair value of total consideration $ 35,846 Assets acquired and liabilities assumed Cash and cash equivalents $ 3,442 Tangible assets 283 In-process research and development intangible assets 21,692 Liabilities (2,396 ) Debt (3,407 ) Deferred tax liability (7,375 ) Total assets acquired and liabilities assumed 12,239 Goodwill 23,607 Total $ 35,846 The provisional amount of deferred tax liability acquired at the Merger date reflects a blended tax rate which included the federal statutory rate and an estimated rate for corporate tax in the state of California as the company was evaluating its ongoing nexus in California. However, as of December 31, 2017, the Company determined that there is no ongoing nexus, and as such, revised the tax rate utilized to derive the amount of the deferred tax liability on the acquired in-process research and development. The revision resulted in a $1.3 million reduction in the deferred tax liability and a corresponding $1.3 million increase in the carrying value of goodwill as of December 31, 2017. The revision had no impact on the Consolidated Statements of Operations and Comprehensive Loss during the year ended December 31, 2017. The final allocation of the purchase price is dependent on the finalization of the valuation of the fair value of assets acquired and liabilities assumed and may differ from the amounts included in these financial statements. The Company expects to complete the final allocation as soon as practical but no later than one year from the acquisition date. Management does not expect adjustments, if any, resulting from changes to the purchase price allocation, to have a material effect on the Company’s financial position or results of operations. Mast Pro Forma (Unaudited) The following summary pro forma financial information reflects the consolidated operations of the Company for the year ended December 31, 2017 as if the Merger with Mast had occurred on January 1, 2016. This summary pro forma information is not necessarily representative of what the Company’s results of operations would have been had the Merger in fact occurred on January 1, 2016, and is not intended to project the Company’s results of operations for any future period. Included in the Savara consolidated statement of operations for the year ended December 31, 2017 is $0 of revenue and $1.6 million of net loss before income tax generated by Mast since April 27, 2017, the acquisition date. Year ending December 31, 2017 2016 Net revenues $ 94 $ 528 Net loss $ (20,420 ) $ (42,560 ) Pro forma combined net loss includes adjustments to remove transaction costs of $8.5 million and $0.6 million for the years ended December 31, 2017 and 2016, respectively, as these costs do no have a continuing impact on operations, and a reduction in interest expense of $1.4 million for the year ended December 31, 2016 due to the new debt facility (Note 9) entered into as part of the Merger and contemporaneous repayment of the pre-Merger debt of Mast. (b) Serendex On May 13, 2016, the Company entered into a Business Transfer Agreement with Serendex under which Serendex agreed to sell, transfer and assign to Savara all of its assets and subsidiaries, certain of its contracts, and certain of its employees and liabilities. Serendex was a limited liability company incorporated in Denmark and was listed on the Oslo Stock Exchange until May 4, 2016. On July 15, 2016, the Company completed the acquisition of Serendex through its wholly-owned subsidiary, Savara ApS, a limited liability company established under the laws in Denmark. The Serendex Acquisition was an important step in fulfilling Savara’s vision to become a specialty pharmaceutical company focused on rare respiratory diseases. Serendex was a biopharmaceutical development company that was advancing a pipeline and portfolio of novel inhalation therapies for the treatment of severe pulmonary conditions. Through this acquisition, Savara gained access to the late-stage Molgradex for the treatment of PAP, with a Phase 2/3 clinical study ongoing in the EU and Japan at that time. In addition to Molgradex, Savara gained access to an experienced development team familiar with all aspects of the Molgradex program. For the purchase consideration, Savara agreed to provide the seller with 1,965,400 shares of Savara’s common stock. In addition to the purchase consideration shares, Savara Inc. agreed to pay the seller (i) $5.0 million upon receipt of marketing approval of the medicinal product Molgradex, an inhalation f ormulation of recombinant human GM-CSF for the treatment of pulmonary alveolar proteinosis (the Product) by the European Medicines Agency, (ii) $15.0 million upon receipt of marketing approval of the Product by the United States Food and Drug Administration, and (iii) $1.5 million upon receipt of marketing approval of the Product by the Japanese Pharmaceuticals and Medical Devices Agency (the Contingent Milestone Payments). The Company estimated the likelihood of approval in each region, separately, based on the product candidate’s current phase of development and utilizing published studies of clinical development success rates for comparable non-oncology orphan drugs. The present value of the potential cash outflows from the probability weighted Contingent Milestone Payments was then estimated by taking into consideration that the Contingent Milestone Payments are similar to a business expense of the Company and would be senior to any Company debt obligations. The resulting weighted average present value factor was applied to discount the probability adjusted Contingent Milestone Payments for each region to derive the fair value of the Contingent Milestone Payments. The Company reassesses the factors affecting the Contingent Milestone Payments on a regular basis and records any necessary adjustment to the corresponding liability n the Balance Sheet. The Company accounted for the acquisition as a business combination by applying the acquisition method, which requires the assets acquired and liabilities assumed be recorded at fair value with limited exceptions. The Company used the Multi-Period Excess Earnings Model (MPEEM), a form of the income approach to value the in-process research and development intangible asset. The excess of the purchase price over the assets acquired and liabilities assumed represents goodwill. The goodwill is primarily attributable to the synergies expected to arise after the acquisition and is not expected to be deductible for tax purposes. The following table summarizes the consideration that the Company paid for Serendex and the amounts of the assets acquired and liabilities assumed recognized at the acquisition date: Purchase Consideration (in thousands) Fair value of Savara common stock issued for the acquistion $ 2,851 Estimated fair value of Contingent Milestone Payments 9,524 Fair value of total consideration $ 12,375 Assets acquired and liabilities assumed Inventory $ 18 Income tax receivable 872 Propety and equipment, net 28 Current liabilities (320 ) Deferred tax liability (2,419 ) In-process research and development intangible asset 10,994 Total assets acquired and liabilities assumed 9,173 Goodwill 3,202 Total $ 12,375 Serendex Pro Forma (Unaudited) The following pro forma financial information reflects the consolidated results of operations of the Company for the year ended December 31, 2017 as if the acquisition of Serendex had taken place on January 1, 2016 (in thousands). The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transactions been effected on the assumed date. Included in the Company’s consolidated Statement of Operations and Comprehensive Loss for the years ended December 31, 2017 and 2016 (since July 15 2016, the acquisition date) was $0 of revenue and $11.5 million and $2.8 million, respectively, of net loss before income tax generated by the Serendex (in thousands). Year ending December 31, 2017 2016 Net revenues $ — $ 400 Net loss $ (28,229 ) $ 17,748 |
Convertible Promissory Notes
Convertible Promissory Notes | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Convertible Promissory Notes | 8. Convertible Promissory Notes A. 2016 Convertible Promissory Note During 2016, the Company borrowed approximately $4.4 million from several investors under convertible subordinate promissory notes (the “2016 Notes”). Under the amended terms, the 2016 Notes converted into equity in connection with the Merger. See further discussion under Accounting for the 2016 Notes below. The 2016 Notes accrued interest at 8.0% per annum computed on the basis of the actual number of days elapsed and a 365-day year. All unpaid principal, together with any then accrued but unpaid interest was due and payable on the earliest of (i) June 30, 2018 (the “Maturity Date”), (ii) the closing of a change of control as defined, or (iii) the occurrence of an event of default, as defined (such earliest date is hereinafter referred to as Maturity). The 2016 Notes were prepayable only with the written consent of the holders of a majority of the principal amount of the then-outstanding 2016 Notes. The following paragraphs describe the original and amended conversion features of the 2016 Notes. Automatic Conversion The principal and any accrued interest automatically convert into shares of Qualified Private Placement Financing Securities at the 2016 Note Conversion Price, upon the closing of a Qualified Private Placement Financing (“Private Placement Automatic Conversion”). In the event of a Private Placement Automatic Conversion, the 2016 Notes are converted into a number of Qualified Private Placement Financing Securities determined by dividing (i) the aggregate outstanding principal amount and accrued but unpaid interest by (ii) the 2016 Note Conversion Price. A Qualified Private Placement Financing is defined as the next Private Placement transaction (or series of related transactions) after the date of the 2016 Notes and before Maturity in which the Company issues and sells shares of its preferred stock in exchange for aggregate gross proceeds of at least $5 million (excluding amounts received upon conversion of indebtedness). Private Placement means any equity financing transaction (or series of related transactions) pursuant to a private placement exempt from the registration requirements of the Securities Act, other than pursuant to the exemption provided by Regulation A under the Securities Act (i.e., not a Regulation A Offering or an Initial Public Offering). The Note Conversion Price is the lesser of (A) (i) the price per share of the Next Round Securities, Qualified Financing Shares or Regulation A Offering Shares, as the case may be, times (ii) 0.8 (i.e. a 20% discount), or (B) the quotient obtained by dividing $125 million (the “Valuation Cap”) by the Company’s fully diluted capitalization immediately prior to the initial closing of the Qualified Financing, Non-Qualified Financing, Qualified Regulation A Offering or Non-Qualified Regulation A Offering in which the Notes are converted. Non-Qualified Private Placement Financing means any transaction (or series of related transactions) after the date of the 2016 Notes and before Maturity in which the Company issues and sells shares of its capital stock in any Private Placement transaction that is not deemed to be a Qualified Private Placement Financing. Next Round Securities means the equity shares sold in a Non-Qualified Private Placement Financing. The entire outstanding principal amount of the 2016 Notes and any accrued but unpaid interest will be converted automatically into shares of Regulation A securities at the Note Conversion Price upon the closing of a Qualified Regulation A Offering. In the event of an automatic conversion under a Qualified Regulation A Offering, the 2016 Notes will be converted into that number of Regulation A securities determined by dividing (i) the aggregate outstanding principal amount of the 2016 Notes and any accrued but unpaid interest by (ii) the Note Conversion Price. A Qualified Regulation A Offering means a Regulation A Offering with gross proceeds to the Company of at least $5 million in one or more closings during a twelve-month period, excluding amounts received on conversion of the 2016 Notes. Voluntary Conversion In the event that the Company consummates a Non-Qualified Private Placement Financing, at the option of each holder or holders of a majority of the outstanding aggregate principal amount, all or part of the outstanding principal and any accrued interest may be converted into Next Round Securities. A Non-Qualified Private Placement Financing is any transaction (or series of related transactions) after the date of the 2016 Notes and before Maturity in which the Company issues and sells shares of its capital stock in any Private Placement transaction that is not deemed to be a Qualified Private Placement Financing at the applicable 2016 Note Conversion Price as defined above. In the event that the Company consummates a Non-Qualified Regulation A Offering (i) at the option of the holder, but subject to the consent of the board of directors, all or part of the outstanding principal amount of the 2016 Notes and any accrued but unpaid interest may be converted into Regulation A Securities, and (ii) at the option of the holders of a majority of the outstanding principal amount of the 2016 Notes, all or part of the outstanding principal amount of the 2016 Notes and any accrued but unpaid interest will be converted into shares of Regulation A Securities. In the event of such conversion, the 2016 Notes will be converted into that number of shares of Regulation A Securities determined by dividing (x) the aggregate outstanding principal amount of the 2016 Notes and any accrued but unpaid interest by (y) the Note Conversion Price. A Non-Qualified Regulation A Offering means the closing of a Regulation A Offering with gross proceeds to the Company of less than $5 million excluding amounts received on conversion of the 2016 Notes. Change in Control Conversion In the event of a Change of Control after the date of the 2016 Notes but prior to Maturity, at the option of each holder or holders of a majority of the outstanding aggregate principal amount, all or part of the outstanding principal amount and any accrued interest, (i) may be converted into the number of shares of Series C Redeemable Convertible Preferred Stock (“Series C Preferred Stock”) determined by dividing (x) the aggregate outstanding principal amount and any accrued interest by (y) the quotient obtained by dividing (1) the Valuation Cap by (2) the Company’s capital stock outstanding immediately prior to such Change of Control. A Change of Control means any liquidation, dissolution or winding up of the Company, either voluntary or involuntary, and shall be deemed to be occasioned by, or to include, (i) a merger or consolidation of the Company into or with another entity after which the stockholders of the Company immediately prior to such transaction do not own, immediately following the consummation of the transaction by virtue of their shares in the Company or securities received in exchange for such shares in connection with the transaction, a majority of the voting power of the surviving entity in proportions substantially identical to those that existed immediately prior to such transaction and with substantially the same rights, preferences, privileges and restrictions as the shares they held immediately prior to the transaction, (ii) the sale, transfer or other disposition (but not including a transfer or disposition by pledge or mortgage to a bona fide lender) of all or substantially all of the assets of the Company (other than to a wholly-owned subsidiary), or (iii) the sale or transfer by the Company or its stockholders of more than 50% of the voting power of the Company in a transaction or series of related transactions other than in a transaction or series of transactions effected by the Company primarily for financing purposes. IPO Conversion Upon an initial public offering of the Company’s common stock, the entire outstanding principal amount plus any accrued interest under the 2016 Notes automatically converts into shares of Company common stock at the IPO Conversion Price. The IPO Conversion Price means the lesser of the (x) quotient obtained by dividing (1) the Valuation Cap by (2) the Company’s fully diluted capitalization immediately prior to the consummation of the initial public offering or (y) quotient obtained by dividing (1) the pre-money valuation of the Company approved by the board of directors in connection with the Initial Public Offering, by (2) the Company’s fully diluted capitalization immediately prior to the consummation of the Initial Public Offering. Maturity Date Conversion The entire outstanding principal amount and any accrued interest under the 2016 Notes automatically converts into shares of Series C Preferred Stock at the Series C Price upon the close of business of the Maturity Date. In the event of such automatic conversion, the 2016 Notes convert into that number of Series C Preferred Stock determined by dividing (i) the aggregate outstanding principal amount of the 2016 Notes plus any accrued interest by (ii) the Series C Price. The Series C Price is $5.2605 as adjusted for stock dividends, stock splits, recapitalizations and other similar events. Public Listing Conversion The 2016 Notes and the Series C Warrants, issued with the note subscriptions, were amended to include a conversion clause in the case of the Merger. The amendment provides the warrant holder the right to voluntarily exercise the Series C Warrants; however, the 2016 Notes would be automatically converted in the case of the Merger. Upon the consummation of the Merger or a similar transaction that results in the listing of capital stock of the Company or shares issued in exchange for the capital stock of the Company, the entire principal amount plus any accrued interest under the 2016 Notes automatically converts into shares of Common Stock at $4.22 per share, which was 80% of the estimated Merger per share value, for notes issued on or prior to August 15, 2016 and 80% of the amount equal to the average trading price of Mast’s common stock for the twenty day period ending two days prior to the closing of the Merger, as adjusted by the Exchange Ratio described in the Merger Agreement. Accounting for the 2016 Notes Management determined that the automatic conversion upon a Qualified Private Placement Financing, a Qualified Regulation A Offering, a Non-Qualified Private Placement Financing, or a Non-Qualified Regulation A Offering as defined above represented, in substance, a put option (redemption feature) designed to provide the investor with a fixed monetary amount, settleable in shares. Management determined that this put option should be separated and accounted for as a derivative primarily because the put option met the net settlement criterion and the settlement provisions were not consistent with a fixed-for-fixed equity instrument. With respect to the Series C Warrants issued to investors who purchased 2016 Notes prior to August 15, 2016, management determined that the Series C Warrants should also be separated and accounted for as a derivative and classified as a liability. Both the put option, with a fair value of approximately $1.0 million and warrant liability, with a fair value of approximately $0.3 million at inception, were initially recorded as derivative liabilities on the accompanying balance sheet and a corresponding discount to the 2016 Notes. The Company accreted the discount to interest expense on the statement of operations and comprehensive loss over the term of the 2016 Notes using the effective interest rate method. The Company recorded interest expense of $0.2 million during the year ended December 31, 2017 related to the accretion of the total discount through the date of conversion. Upon the Merger, the date of the automatic conversion under the Public Listing Conversion provisions, the 2016 Notes were surrendered in exchange for shares of the Company’s common stock after giving effect to the Exchange Ratio. The debt host contract and separated derivative liability were both subject to extinguishment accounting, and a loss in the amount of $0.9 million was recorded in the Statement of Operations and Comprehensive Loss. The loss was calculated as the difference between the net book value of the 2016 Notes plus the fair value of the put option immediately prior to the Automatic Conversion, and the fair value of the common stock into which the 2016 Notes were converted. B. 2017 Convertible Promissory Note During 2017, the Company borrowed approximately $3.6 million from several investors under convertible subordinate promissory notes (the “2017 Notes”) which converted into equity in connection with the Merger. The 2017 Notes accrued interest at 8.0% per annum computed on the basis of the actual number of days elapsed and a 365-day year. All unpaid principal, together with any then accrued but unpaid interest was due and payable on the earliest of (i) June 30, 2018, (ii) the closing of a change of control as defined, or (iii) the occurrence of an event of default, as defined (such earliest date is hereinafter referred to as Maturity). The 2017 Notes were prepayable only with the written consent of the holders of a majority of the principal amount of the then-outstanding 2017 Notes. The terms and conditions of the 2017 Notes were substantially consistent with the 2016 Notes as described above, other than the Public Listing Conversion feature which is described below. Public Listing Conversion Immediately prior to, but in any event conditioned upon the consummation of a merger or similar transaction that results in the listing of capital stock the Company or shares issued in exchange for the capital stock of the Company on any tier of any U.S. national securities exchange, including the transactions described in the Merger Agreement, the entire outstanding principal amount of the 2017 Notes, any accrued but unpaid interest and any other amounts payable under the 2017 Notes shall be converted automatically into shares of the Company’s common stock, as adjusted for the Exchange Ratio, at the Reverse Merger Conversion Price. Upon such occurrence, the 2017 Notes shall be converted into that number of shares of common stock determined by dividing (i) the aggregate outstanding principal amount of the 2017 Notes, any accrued but unpaid interest, and any other amounts payable under the 2017 Notes by (ii) the Reverse Merger Conversion Price. The Reverse Merger Conversion Price means eighty percent of the amount equal to the average trading price of Mast’s common stock for the twenty-day period prior to the Merger date. Accounting for the 2017 Notes Management determined that the automatic conversion upon a Qualified Private Placement Financing, a Qualified Regulation A Offering, a Non-Qualified Private Placement Financing, or a Non-Qualified Regulation A Offering as defined above represented, in substance, a put option (redemption feature) designed to provide the investor with a fixed monetary amount, settleable in shares. Management determined that this put option should be separated and accounted for as a derivative primarily because the put option met the net settlement criterion and the settlement provisions were not consistent with a fixed-for-fixed equity instrument. The put option, with a fair value of approximately $0.8 million at inception, was initially recorded as a derivative liability on the accompanying balance sheet and a corresponding discount to the 2017 Notes. The Company accreted the discount to interest expense on the statement of operations and comprehensive loss over the term of the 2017 Notes using the effective interest rate method. The Company recorded interest expense of approximately five thousand dollars during the year ended December 31, 2017 related to the accretion of the discount through the date of conversion. Upon the Merger, the date of the automatic conversion under the Public Listing Conversion provisions, the 2017 Notes were surrendered in exchange for the Company’s common stock after giving effect to the Exchange Ratio. The debt host contract and separated derivative liability were both subject to extinguishment accounting, and a loss in the amount of approximately $0.9 million was recorded in the Statement of Operations and Comprehensive Loss. The loss was calculated as the difference between the net book value of the 2017 Notes plus the fair value of the put option immediately prior to the Automatic Conversion, and the fair value of the common stock into which the 2017 Notes were converted. |
Debt Facility
Debt Facility | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Debt Facility | 9. Debt Facility On April 28, 2017, the Company entered into a loan and security agreement with Silicon Valley Bank (the “Loan Agreement”). Silicon Valley Bank has been granted a perfected first priority lien in all of our assets with a negative pledge on our intellectual property. The Loan Agreement provides for a $15 million debt facility, of which the first tranche, or $7.5 million, was immediately available to the Company upon completion of the Merger with a minimum market cap of $100 million. The Company executed the first tranche in early May 2017. The primary use of the capital was for the repayment of $3.7 million of principal debt and fees of Mast assumed in the Merger. The residual capital will be utilized to fund ongoing development programs of the Company and for general corporate purposes. Under the terms of the Loan Agreement, the Company may, but is not obligated to draw a second tranche of $7.5 million available through June 30, 2017, subject to the achievement of certain corporate milestones specifically a minimum new capital raise with combined proceeds of at least $40 million through a secondary offering, private investment in public entity (PIPE), ATM, partnerships or grant to be received within twelve months of signing the agreement. On June 15, 2017, following an underwritten public offering of 9,034,210 shares of the Company’s common stock and the sale of 23,550 shares of the Company’s common stock under the Sales Agreement (Note 12), the Company executed the second tranche of the Loan Agreement for $7.5 million as the financing conditions under the Loan Agreement had been met. The Loan Agreement contains customary affirmative and negative covenants, including among others, covenants limiting our ability and our subsidiaries to dispose of assets, permit a change in control, merge or consolidate, make acquisitions, incur indebtedness, grant liens, make investments, make certain restricted payments and enter into transactions with affiliates, in each case subject to certain exceptions. The Loan Agreement bears interest at the prime rate reported in The Wall Street Journal, plus a spread of 4.25%. Interest only payments are due through September 2018 followed by monthly payments of principal plus interest over the following thirty (30) months. Since the second tranche was fully extended, the interest only period was extended for an additional six (6) months, through March 2019 followed by monthly payments of principal plus interest over the following twenty-four (24) months through the maturity date of March 1, 2021 under the Loan Agreement provisions. We were obligated to pay customary closing fees and are obligated to pay a final payment of 6.0% of the aggregate principal amount of term loans advanced under the facility. The end of term charge of $0.9 million will be due on the scheduled maturity date and is being recognized as an increase to the principal with a corresponding charge to interest expense over the term of the facility using the effective interest method. In connection with the Loan Agreement, we paid $0.1 million in legal costs directly attributable to issuing the debt instrument. Such charges were accounted for as debt issuance costs and are being amortized to interest expense using the effective interest method through the scheduled maturity date. Upon funding the first tranche of the Loan Agreement, the Company was obligated to issue warrants to purchase shares of the Company’s common stock equal to 3.0% of the funded amount divided by the exercise price to be set based on the average price per share over the preceding 10 trading days prior to closing. The number of shares callable under the warrant agreement for the first tranche and exercise price were 24,725 shares of the Company’s common stock at an exercise price of $9.10 per share, with a ten year life, expiring April 28, 2027 (“April 2017 Warrants”). Upon funding the second tranche of the Loan Agreement, the Company was obligated to issue warrants to purchase shares of the Company’s common stock equal to 3.0% of the funded amount divided by an exercise price to be set based on the average price per share over the preceding 10 trading days prior to funding or the price per share prior to the day of funding. As such, the Company issued a second warrant for 41,736 shares at an exercise price of $5.39 with a ten year life, expiring June 15, 2027 (“June 2017 Warrants”). The April 2017 Warrants and June 2017 Warrants issued were valued using the Black-Scholes option pricing model with the following assumptions: volatility of 71.42% and 71.57%, respectively, expected term of ten years, risk-free interest rate of 2.33% and 2.16%, respectively, and a zero dividend yield. The collective warrant fair value of $0.4 million has been recorded as a debt discount and is being amortized through interest expense using the effective interest method through the scheduled maturity date. Summary of Carrying Value The following table summarizes the components of the debt facility carrying value (in thousands): As of December 31, 2017 Short-term Long-term Principal payments to lender and end of term charge $ — $ 15,151 Debt Issuance costs — (83 ) Debt discount related to warrants — (293 ) Carrying Value $ — $ 14,775 Future minimum payments under the debt facility are as follows (in thousands): Year Ending December 31, 2018 $ — 2019 5,625 2020 7,500 2021 2,775 Total future minimum payments 15,900 Unamortized end of term charge (749 ) Debt issuance costs and debt discount (376 ) Total minimum payment 14,775 Short-term portion — Long-term debt facility $ 14,775 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 10. Fair Value Measurements The Company measures and reports certain financial instruments at fair value on a recurring basis and evaluates its financial instruments subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them in each reporting period. The Company determined that certain investments in debt securities classified as available-for-sale securities were Level 1 financial instruments. Additional investments in corporate debt securities and commercial paper are considered Level 2 financial instruments because the Company has access to quoted prices, but does not have visibility to the volume and frequency of trading for all of these investments. For the Company’s investments, a market approach is used for recurring fair value measurements and the valuation techniques use inputs that are observable, or can be corroborated by observable data, in an active marketplace. Foreign exchange derivatives not designated as hedging instruments are considered Level 2 fair value measurements. The Company’s foreign exchange derivative instruments are typically short-term in nature. The Company also determined that the warrant liability for the Series B Warrants and Series C Warrants, the put options on the 2016 Notes and 2017 Notes, described further in Note 10, and the contingent consideration, described further below, were Level 3 financial instruments. The fair value of these instruments as of December 31, 2017 and 2016 was as follows (in thousands): Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2017: Cash equivalents: U.S. Treasury money market funds $ 4,540 $ — $ — U.S. government securities — — — Commercial paper — 1,029 — Repurchase agreements — 2,500 — Short-term investments: U.S. government securities $ 11,885 $ — $ — Asset backed securities — 8,383 — Corporate securities — 22,082 — Commercial paper — 29,842 — Other assets: Foreign exchange derivatives not designated as hedging instruments $ — $ 40 $ — Liabilities: Contingent consideration $ — $ — $ 11,948 As of December 31, 2016: Liabilities: Put option $ — $ — $ 979 Warrant liability — — 303 Contingent consideration — — 9,708 The estimated fair value of the put option on the 2016 Notes was determined using a multi-scenario probability weighted average method analysis in which the future probability of the equity financing event or Merger was weighted for its respective probability. The Company used the following assumptions to value the put option on the 2016 Notes and 2017 Notes as of December 31, 2017 and 2016. Upon the Merger date of April 27, 2017, the 2016 Notes and 2017 Notes were automatically converted into shares of common stock of the Company Assumption December 31, 2017 December 31, 2016 Discount rate — 0.43 % Probability of event — 85.0 % Changes in the unobservable inputs noted above would impact the fair value of the put options and have a corresponding impact on the Company’s net loss. The probability of the automatic conversion feature was determined by management based on its consideration of the expected timeline for the next round of Financing, Merger, and historical experience. Increases (decreases) in discount rate would decrease (increase) the value of the put options, and an increase (decrease) in the probability of the equity financing event or Merger event occurring would increase (decrease) the value of the put options. The estimated fair value of the warrant liability (Series B Warrants and Series C Warrants) was determined using a Noreen Wolfson option pricing model. The assumptions used in valuing these warrants are presented in the table below. The warrant liability was reclassified as common equity upon the Merger date. Assumption December 31, 2017 December 31, 2016 Expected term — 0.42 – 4.50 Expected dividend yield — — Expected volatility — 44.65% - Risk-free interest rate — 0.58% - 1.82% Changes in the unobservable inputs noted above would impact the fair value of the liabilities and have a corresponding impact on the Company’s net loss. Increases (decreases) in the expected term and expected volatility would increase (decrease) net loss and the value of the warrant liability and an increase(decrease) in the risk-free interest rate would decrease (increase) net loss and the value of the warrant liability. Pursuant to the acquisition of certain assets, liabilities, and subsidiaries of Serendex (see Note 1), Savara agreed to pay the seller, in addition to a stipulated amount of shares of Savara’s common stock, (i) $5 million upon receipt of marketing approval of Molgradex (the Product) by the European Medicines Agency, (ii) $15 million upon receipt of marketing approval of the Product by the FDA, and (iii) $1.5 million upon receipt of marketing approval of the Product by the Japanese Pharmaceuticals and Medical Devices Agency (the “Contingent Milestone Payments”). The Company estimates the likelihood of approval in each region, separately, based on the product candidate’s current phase of development and utilizing published studies of clinical development success rates for comparable non-oncology orphan drugs. The present value of the potential cash outflows from the probability weighted Contingent Milestone Payments is then estimated by taking into consideration that the Contingent Milestone Payments are similar to a business expense of the Company and would be senior to any Company debt obligations. The resulting weighted average present value factor is then applied to discount the probability adjusted Contingent Milestone Payments for each region to derive the fair value of the Contingent Milestone Payments. The following tables sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instrument (in thousands) for the year ended December 31, 2017 and 2016: Warrant Liability Put Option on 2016 Note and 2017 Note Contingent Consideration As of December 31, 2015 $ 274 $ — $ — Put option at issuance of 2016 Notes — 977 — Contingent consideration — — 9,524 Issuance of Series C Warrants 259 — — Change in fair value (230 ) 2 184 Balance at December 31, 2016 $ 303 $ 979 $ 9,708 Change in fair value 67 169 2,240 Put option at issuance of 2017 Notes — 828 — Reclassification of warrant liability to common equity (370 ) — — Conversion of 2016 and 2017 Notes — (1,976 ) — Balance at December 31, 2017 $ — $ — $ 11,948 |
Derivative Financial Instrument
Derivative Financial Instruments | 12 Months Ended |
Dec. 31, 2017 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | 11. Derivative Financial Instruments In the normal course of business, the Company is exposed to the impact of foreign currency fluctuations. The Company seeks to limit these risks by following risk management policies and procedures, including the use of derivatives. The Company’s derivative contracts, which are not designated as hedging instruments, principally address short-term foreign currency exchange. The estimated fair value of the derivative contracts was based upon the relative exchange rate as of the balance sheet date. Accordingly, any gains or losses resulting from variances between this exchange rate the exchange rate at the contract inception date were recognized as other income or expense in the Consolidated Statements of Operations and Comprehensive Loss. As of December 31, 2017, there were approximately $2.7 million of unsettled forward exchange contracts to purchase foreign currency which was offset by approximately $2.6 million of related contactual liabilites and for which the net derivative financial instruments were recorded at estimated fair value in other current assets in the amount of forty thousand dollars. |
Shareholders_ Equity
Shareholders’ Equity | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Shareholders’ Equity | 12. Shareholders’ Equity Public Offerings On June 7, 2017, the Company completed an underwritten public offering consisting of 9,034,210 shares of its common which included 613,157 shares upon the partial exercise of the underwriters' option to purchase additional shares of Savara common stock at the public offering price, less the underwriting discounts and commissions. The underwriters’ option to purchase the remaining balance of additional shares expired as of June 30, 2017. The net proceeds from the offering, after deducting the underwriting discounts and commissions and offering expenses, were approximately $39.5 million. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes, which include, but are not limited to, the funding of clinical development of and pursuing regulatory approval for its product candidates, and general and administrative expenses. The public offering was executed under an existing shelf registration statement as previously filed with the Securities and Exchange Commission on August 12, 2015 and declared effective on August 19, 2015. On October 27, 2017, the Company completed an underwritten public offering consisting of 5,250,000 shares of its common stock, in addition to pre-funded warrants to purchase 775,000 shares of its common stock. Under the terms of the offering, the underwriter was granted an option to purchase 787,500 additional shares of Savara common stock at the public offering price, less the underwriting discounts and commissions. On November 2, 2017, the underwriters exercised their option to purchase the 787,500 additional shares resulting in net proceeds of approximately $5.8 million. The net proceeds from the offering, including the option to purchase additional shares, after deducting the underwriting discounts and commissions and offering expenses, were approximately $50 million. Savara intends to use the net proceeds from these offerings for working capital and general corporate purposes, which include, but are not limited to, the funding of clinical development of and pursuing regulatory approval for its product candidates including an indication expansion for Molgradex for the treatment of Nontuberculous Mycobacteria (“NTM”) lung infection, and general and administrative expenses. The public offerings were executed under an existing shelf registration statement as previously filed with the Securities and Exchange Commission on August 12, 2015 and declared effective on August 19, 2015. In connection with the offering, on October 12, 2017, the Company was required to suspend its activity under the Sales Agreement for ninety-days. The Company commenced its sales acitivty under the Sales Agreement effective February 15, 2018. Common Stock Sales Agreement/ ATM On April 27, 2017, the Company delivered written notice to Cowen and Company, LLC that it was terminating its prior sales agreement, dated August 21, 2015, and on April 28, 2017, the Company entered into a Common Stock Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which the Company may offer and sell, from time to time, through Wainwright, shares of Savara’s common stock, par value $0.001 per share (the “Shares”), having an aggregate offering price of not more than $18.0 million. The Shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3. Subject to the terms and conditions of the Sales Agreement, Wainwright will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has provided Wainwright with customary indemnification rights, and Wainwright will be entitled to a commission at a fixed commission rate equal to 3.0% of the gross proceeds per Share sold. Sales of the Shares, if any, under the Sales Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement. During the year ended December 31, 2017, the Company sold 198,298 shares of common stock under the sales agreement, for net proceeds, of approximately $1.7 million. Common Stock The Company’s amended and restated certificate of incorporation, effective upon the completion of the Merger, authorizes the Company to issue 501 million shares of common and preferred stock, consisting of 500 million shares of common stock with $0.001 par value and 1 million shares of preferred stock with $0.001 par value. The following is a summary of the Company’s common stock at December 31, 2017 and 2016. December 31, 2017 December 31, 2016 Common stock authorized 500,000,000 27,000,000 Common stock outstanding 30,509,522 3,162,573 The Company’s shares of common stock reserved for issuance as of December 31, 2017 and 2016 were as follows: December 31, 2017 December 31, 2016 Series A Preferred Stock — 1,799,906 Series B Preferred Stock — 5,675,387 Series C Preferred Stock — 4,452,582 Series B Warrants — 289,966 Series C Warrants — 125,885 Warrants from Mast acquired in Merger 1,152,231 — Warrants Converted Pursuant to Merger 74,992 — April 2017 SVB Warrants 24,725 — June 2017 SVB Warrants 41,736 — Prefunded warrants 775,000 — Stock options outstanding 1,916,832 1,814,645 Issued and unvested RSU's 86,875 — Total shares reserved 4,072,391 14,158,371 Redeemable Convertible Preferred Stock Prior to the Merger and the effect of the Exchange Ratio, the Company had 11,927,875 issued and outstanding shares of preferred stock, of which 1,799,906 shares were designated as Series A redeemable convertible preferred stock ("Series A"), 5,675,387 shares were designated as Series B redeemable convertible preferred stock ("Series B"), and 4,452,582 shares were designated as Series C convertible preferred stock ("Series C"). In the Merger, the previously outstanding shares of Series A and Series B preferred stock were converted on a one-to-one basis into shares of common stock and then subject to the Exchange Ratio. Due to the conversion of the 2016 Notes and 2017 Notes upon the Merger, the holders of Series C preferred stock received broad-based weighted average anti-dilution protection such that the previously outstanding shares of Series C preferred stock were converted on a 1:1.01706 basis (the “Anti-Dilution Conversion Ratio”) into shares of common stock and then adjusted for the Exchange Ratio. Following the Merger, there were no shares of preferred stock outstanding. No dividends on the convertible preferred stock were declared by the Board of Directors from inception through their conversion into common stock. The following table discloses the outstanding preferred stock immediately prior to the Merger. Par Value Shares Authorized Shares Outstanding Carry Value Liquidation Amount Series A $.001 1,799,906 1,799,906 $ 3,232 $ 3,254 Series B $.001 6,000,000 5,675,387 $ 17,301 $ 17,762 Series C $.001 8,000,000 4,452,582 $ 23,328 $ 23,423 Total 15,799,906 11,927,875 $ 43,861 $ 44,439 Warrants Immediately prior to the Merger, Series B preferred stock warrants were exercised (either on a net exercise basis or for cash) and exchanged for 111,799 shares of the Company’s common stock after giving effect to the Exchange Ratio. Proceeds from the cash exercises were $0.4 million. Pursuant to the Merger, Series C Warrants were converted to warrants to purchase 74,992 shares of the Company’s common stock after giving effect to both the Anti-Dilution Conversion Ratio and Exchange Ratio. The following table summarizes the outstanding warrants for the Company’s common stock as of December 31, 2017: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 401,391 $ 45.50 June 2018 314,446 $ 52.50 November 2019 32,467 $ 7.00 August 2020 403,927 $ 29.40 February 2021 74,992 $ 8.98 June 2021 24,725 $ 9.10 April 2027 41,736 $ 5.39 June 2027 775,000 $ 0.01 October 2024 2,068,684 Beneficial Conversion Feature Due to the conversion of the 2016 Notes and 2017 Notes upon the Merger resulting in an Anti-Dilution Conversion Ratio to the holders of Series C preferred stock and Series C Warrants, a Contingent Beneficial Conversion Feature (“BCF”) was triggered resulting in an intrinsic BCF value attributable to the securities of approximately $0.4 million, collectively. Since the conversion of the Series C preferred stock and Series C Warrants occurred contemporaneously on the BCF commitment date, the Company measured the value on that date and recorded the BCF as a “deemed dividend.” Financial Advisor Fees The Company executed an agreement with Canaccord Genuity in February 2016 as modified in March 2017 (collectively the “Advisory Agreement”) where the Company was obligated to pay Canaccord a success fee upon the closing of the Merger. As of December 31, 2017, following the Merger and public offering on June 7, 2017, the Company paid Canaccord Genuity $1.0 million related to the success fee for the Merger due under the Advisory Agreement following the public offering and which was paid in July 2017. |
Grants and CFF Award
Grants and CFF Award | 12 Months Ended |
Dec. 31, 2017 | |
Health Care Organizations [Abstract] | |
Grants and CFF Award | 13. Grants and CFF Award On March 27, 2013, the Company was issued an additional Federal Grant from the NIH, grant number 2R44HL112393-02, “Development of Inhaled Vancomycin for Treatment of MRSA Infections in CF” in the amount of $3,986,000 with a project period from March 1, 2013 through February 29, 2016. The Company has incurred expenses and recognized associated revenue of $0, $0 and $54,000 related to the Federal Grants for the years ended December 31, 2017, 2016, and 2015, respectively. As of December 31, 2017 and 2016, there were no amounts related to the Federal Grants included in grants and award receivable in the accompanying balance sheets. All amounts recognized as revenue under the Federal Grants through December 31, 2017 have been collected. In September 2013, the Company received a $1.7 million award (“CFF Award”) from the Cystic Fibrosis Foundation Therapeutics, Inc. (“CFFT”). The CFF Award includes disbursements to the Company based on the achievement of certain milestones. For the years ended December 31, 2017, 2016, and 2015, the Company recognized $0, $400,000 and $0 in revenue related to the CFF Award, respectively. The Company is subject to certain royalty payments due to the CFFT under the CFF Award based on commercialization of the Company’s product and either the achievement of certain sales volumes or a Change in Control Transaction, as defined below. As of December 31, 2017 and 2016, $0 and $400,000, related to the CFF Award were included in grants and award receivable in the accompanying balance sheets. The $400,000 award receivable recorded at December 31, 2016 was subsequently collected in January 2017. Commercial Approval Royalty A royalty is payable to the CFFT equal to three (3) times the amount of the CFF Award upon approval of the Company’s product for commercial use. The royalty is payable in equal installments of 33% due 60 days after first commercial sale; 33% due 90 days of the first anniversary of the first commercial sale; and 34% due within 90 days of 2nd anniversary of first commercial sale. This royalty will be reduced upon Change in Control Transaction payments as described below. As the Company’s product has not yet been approved for commercial use, the Company has not recorded a liability for the commercial approval royalty. Additional Royalties In addition, if net sales exceed $50.0 million for any calendar year occurring during the first five years after the first commercial sale, the Company must remit payment to the CFFT equal to one (1) times the CFF Award. Furthermore, if net sales exceed $100.0 million for any calendar year occurring during the first five years after first commercial sale, the Company must remit an additional payment to the CFFT equal to one (1) times the CFF Award. Given the Company has not recognized any sales from the Company’s product, the Company has not recorded a liability for any amounts due as additional royalties. Change in Control Royalty Upon a Change in Control Transaction, as defined below, occurring prior to the second anniversary date of the effective date of the CFF Award, September 30, 2015, the Company must remit a royalty payment to the CFFT equal to 5% of the proceeds from the Change in Control Transaction but not to exceed an amount equal to two times the CFF Award proceeds received. Upon a Change in Control Transaction occurring after the second anniversary date of the effective date of the CFF Award, the Company must remit a royalty payment to the CFFT equal to 5% of the proceeds from the Change in Control Transaction or a sale or license of the AeroVanc program with a third party but not to exceed an amount equal to three times the CFF Award. A Change in Control Transaction is defined as the consummation (single or series of transactions) constituting (i) merger, share exchange, or other reorganization; (ii) sale by one of more stockholders of a majority voting power in the Company; or (iii) sale of substantially all of the assets of the Company. The Company has determined that a change of control is not probable and as such, has not recorded a liability for the change in control royalty. The CFF Award may not be assigned by any party (other than to an affiliate or to a successor to substantially all of such party’s assets or business to which the CFF Award relates) without the consent of the other party. If the Company initiates an “Interruption,” as defined under the CFF Award, for more than one year at any time before the first commercial sale of the product under the AeroVanc Program, the Company ceases to conduct, or has ceased to use commercially reasonable efforts to advance the research and development or commercialization of the AeroVanc Program, the Company shall transfer an exclusive, worldwide license to the CFFT of the Company’s research and development of the product under the AeroVanc Program limited to the right to manufacture, have manufactured, license, sell, use, support, offer to sell, any related invention from the Company’s AeroVanc Program. Amendment On November 28, 2017, Savara entered into an amendment agreement to the CFF Award dated September 30, 2013 (“Amended CFF Award”), pursuant to which the amount of the development award available to Savara was increased by $5.0 million to an aggregate of $6.7 million. Pursuant to the terms of the Amended CFF Award, if Savara elects to draw down founds on the increased the award, it is obligated to make royalty payments to CFFT upon the commercialization of AeroVanc. A payment equal to four times the amount Savara receives under the Amended CFF Agreement is due in three installments: 33% due 60 days after first commercial sale of AeroVanc; 33% due within 90 days after the first anniversary of the first commercial sale of AeroVanc; and 34% due within 90 days after the second anniversary of first commercial sale of AeroVanc. Additionally, if net sales of AeroVanc exceed $50.0 million for any calendar year occurring during the first five years after the first commercial sale of AeroVanc, Savara must remit payment to CFFT equal to the amount received by Savara under the Amended CFF Award. Furthermore, if net sales exceed $100.0 million for any calendar year occurring during the first seven years after first commercial sale of AeroVanc, Savara must remit an additional payment to CFFT equal to the amount received by Savara under the Amended CFF Award. Savara is also obligated to make royalty payments to CFFT if Savara enters into a change of control transaction or a sale or license of the AeroVanc program with a third party equal to 7.5% of the amount received from the third party in connection with such transaction, up to a total of four times the amount received by Savara under the Amended CFF Award. Any such payments are to be credited against the royalty payments due upon commercialization of AeroVanc, and Savara must continue paying or cause the third party to assume any remaining royalties payable to CFFT pursuant to the Amended CFF Award. As of December 31, 2017 and 2016, the Company had drawn down $1.7 million, in total, under the CFF Award dated September 2013 but made no draws against the Amended CFF award. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 14. Commitments Operating Leases We are obligated under operating leases for office space. We lease an office space in Copenhagen, Denmark with a lease effective on June 1, 2014 and expiring on November 30, 2019. Our monthly rent is approximately five thousand dollars. On March 23, 2017, we sublet office space located in San Diego, California with rentable office space of approximately 13,707 square feet which previously served as Mast’s corporate headquarters, to a third party. However, as a result of the Merger, the Company no longer had an ongoing need for these facilities. The term of the sub-sublease commenced on July 1, 2017 and expires on May 31, 2020, coterminous with a sublease agreement dated June 19, 2014 with the sublessor. Monthly base rent under the sub-sublease is approximately forty-four thousand dollars, subject to increases of 3.0% annually on the anniversary of the commencement date of the sub-sublease term. However, monthly base rent for calendar month two of the sub-sublease term was abated. On November 29, 2017, we entered into a sublease agreement for a new office space for our corporate headquarters and subleased our previous office space with a lease expiring on November 30, 2019 with monthly rent of approximately five thousand dollars. The term of the sublease for the new space commenced on January 1, 2018 and will continue until July 31, 2021 and we agreed to make monthly rental payments of thirteen thousand dollars, subject to increases of approximately 2% annually on the anniversary of the commencement date of the sublease term. However, monthly base rent for calendar month one of the sublease term was abated. We previously leased office space for our corporate headquarters, prior to our relocation on January 1, 2018, discussed herein, in Austin, Texas pursuant to an operating lease dated November 19, 2012, as amended May 22, 2015 under which we are obligated to remit monthly rental payments of approximately five thousand dollars for the period January 1, 2018 through January 31, 2019 and five thousand six hundred dollars through February 1, 2019. On November 29, 2017, we entered into a sublease agreement pursuant to which the sublessee will assume the office space and these rental payments effective January 1, 2018 except for the first month rent on January 2018. The future minimum annual lease payments under the operating leases are as follows (in thousands): Year Ending December 31, 2018 822 2019 831 2020 396 2021 97 2,146 Rent expense for our office spaces is recognized on a straight-line basis. Rent expense for the years ended December 31, 2017, 2016 and 2015 was $0.3 million, $0.1 million, and $0.1 million, respectively, and reflected an offset of sublessee rental receipts. As of December 31, 2017, the Company leases certain research and development equipment as part of a contract manufacturing arrangement. The leased equipment is accounted for as a capital lease, and the present value of the future minimum lease payments are recorded as a liability on the balance sheet as of December 31, 2017. The future minimum annual lease payments under the capital lease are as follows (in thousands): Year Ending December 31, 2018 $ 292 2019 301 Total minimum lease payments $ 593 Less: imputed interest (31 ) Total capital lease obligation $ 562 Contingent Royalty and Milestone Payments The Company is also subject to certain contingent royalty payments to the CFFT as described in Note 6 and certain manufacturers of Molgradex and related supplies as described in Note 1. Settlement with Clinical Vendor On June 29, 2017, the Company executed a Memorandum of Understanding (“MOU”) with TFS Trial Form Support International AB (“TFS”) and DOT World Co., Ltd. (“DOT”) in order to resolve the issue of outstanding payment for services owed to DOT by Serendex in connection with the Molgradex clinical trial conducted prior to our acquisition of Serendex in July 2016. As part of this MOU, the Company agreed to pay TFS approximately $0.5 million based on an installment payment schedule through December 31, 2017, if Serenova A/S (“Serenova”), the successor to Serendex, failed to pay the parties in full by June 30, 2017. Serenova failed to pay TFS in full by June 30, 2017, and the Company accrued the full settlement amount. During the year ended December 31, 2017, the Company paid $0.5 million of the accrued settlement amount and continued to pursue collection from Serenova. On September 1, 2017, Savara and Serenova entered into a settlement agreement with respect to the matter under which Serenova agreed to make a cash settlement payment to Savara of $0.3 million. Additionally, under the terms of settlement agreement, within ninety days following the cash settlement payment to Savara, which occurred on September 11, 2017, Serenova was provided the right, but not the obligation, to purchase up to 650,000 shares of common stock of Savara at a price per share equal to 90% of the volume weighted average price of Savara’s common stock for the five (5) trading days ending on the date that Serenova elects to purchase such shares. Management determined that this call option should be separated and accounted for as a derivative. Since this call option meets the net settlement criterion and the settlement provisions are consistent with the fixed-for-fixed equity instrument and indexed to the Company’s stock, the derivative instrument is equity-classified. As such, the call option was valued at $0.3 million using the Black-Scholes option pricing model with the following assumptions: volatility 11.08%, expected term of ninety days, risk-free interest rate of 1.04%, and a zero dividend yield. Serenova did not exercise the call option within the ninety day period, and as such, the corresponding warrants were forfeited and cancelled. Risk Management The Company maintains various forms of insurance that the Company's management believes are adequate to reduce the exposure to these risks to an acceptable level. Employment Agreements Certain executive officers are entitled to payments if they are terminated without cause or as a result of a change in control. Upon termination without cause, and not as a result of death or disability, each of such officers is entitled to receive a payment of base salary for three to twelve months following termination of employment and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for three to twelve months or until such officer is covered under a separate plan from another employer. Upon a termination other than for cause or for good reason within twelve months following a change in control, each of such officers will be entitled to the same benefits as upon termination without cause and will also be entitled to certain acceleration of such officer's outstanding unvested options at the time of such termination. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 15. Related Party Transactions Pursuant to the Company’s public offering on June 7, 2017 (Note 12), Zambon SpA purchased 4,693,540 shares of the Company's common stock and holds approximately 15.4% of the Company's outstanding shares and voting interests of the Company as of December 31, 2017. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | 16. Stock-Based Compensation A. 2008 Stock Option Plan The Company adopted the Savara Inc. Stock Option Plan (the “2008 Plan”), pursuant to which the Company had reserved shares for issuance to employees, directors, and consultants. The 2008 Plan includes 1) the option grant program providing for both incentive and non-qualified stock options, as defined by the Internal Revenue Code, and 2) the stock issuance program providing for the issuance of awards that are valued based upon common stock, including restricted stock, dividend equivalents, stock appreciation rights, phantom stock, and performance units. The 2008 Plan also allows eligible persons to purchase shares of common stock at an amount determined by the plan administrator. Upon a participant’s termination, the Company retains the right to repurchase unvested shares issued in conjunction with the stock issuance program at the fair market value per share as of the date of termination. Prior to the closing of the Merger, the Company had issued incentive and non-qualified options and restricted stock to employees and non-employees under the 2008 Plan. The terms of the stock options, including the exercise price per share and vesting provisions, are determined by the board of directors. Stock options were granted at exercise prices not less than the estimated fair market value of the Company’s common stock at the date of grant based upon objective and subjective factors including: third-party valuations, preferred stock transactions with third parties, current operating and financial performance, management estimates and future expectations. Stock option grants typically vest quarterly over three to four years and expire ten years from the grant date, and restricted stock grants vest on a quarterly basis over four years and expire ten years from the grant date. As of December 31, 2017, 562,596 shares of restricted stock had been issued excluding forfeited shares of restricted stock and after giving effect to the Exchange Ratio. Restricted Stock The Company values stock-based compensation related to grants of its restricted stock, which were issued prior to the Merger date, based on the fair value of the Company’s common stock as of the grant date and recognizes the expense over the requisite service period, usually four years, adjusted for estimated forfeitures. To determine the value of its common stock, the Company utilized the Option Pricing Method. The valuation methodology includes estimates and assumptions that require the Company’s judgment. Inputs used to determine the estimated fair value of the Company’s common stock include the equity value of the Company, expected timing to a liquidity event, a risk-free interest rate and the expected volatility. Generally, increases or decreases in these unobservable inputs would result in a directionally similar impact on the fair value measurement of the Company’s common stock. The following table summarizes the restricted share activity for the years ended December 31, 2017 and 2016: Restricted Shares Weighted-Average Grant Date Fair Value Nonvested at December 31, 2015 180,813 $ 0.75 Granted — — Vested (72,402 ) $ 0.73 Forfeited — — Nonvested at December 31, 2016 108,411 $ 0.69 Granted — — Vested (73,176 ) 0.74 Forfeited (19,045 ) 0.5 Nonvested at December 31, 2017 16,190 $ 0.65 The total fair value of restricted stock that vested during the year ended December 31, 2017 was $0.1 million. The total compensation cost related to non-vested restricted stock not yet recognized as of December 31, 2017 was ten thousand dollars, which will be recognized over a weighted average period of approximately .96 years. During the year ended December 31, 2017 and 2016, the Company did not issue any shares of restricted stock to employees under the 2008 Plan. Changes in 2008 Plan Subsequent to the Merger, the Company no longer issues stock based awards under the 2008 Plan. B. 2015 Omnibus Incentive Option Plan The Company operates the 2015 Omnibus Incentive Plan (the “2015 Plan”), which was amended and approved by stockholders in June 2015. The 2015 Plan provides for the grant of incentive and non-statutory stock options, as well as share appreciation rights, restricted shares, restricted share units (“RSUs”), performance units, shares and other share-based awards. Share-based awards are subject to terms and conditions established by our board of directors or the compensation committee of our board of directors. As of December 31, 2017, the number of shares of our common stock available for grant under the 2015 Plan was 84,168 shares. Shares of common stock that are subject to awards granted under the 2015 Plan shall be counted against the shares available for issuance under this plan as one share for each share subject to a stock option or stock appreciation right and as 1.34 shares for each share subject to an award other than a stock option or a stock appreciation right. If any shares of common stock subject to an award granted under any of our stockholder-approved, equity-based incentive plans are forfeited, or an award expires or is settled for cash pursuant to the terms of an award, the shares subject to the award may be used again for awards under the 2015 Plan to the extent of the forfeiture, expiration or cash settlement. The shares of common stock will be added back as one share for every share of common stock if the shares were subject to a stock option or stock appreciation right, and as 1.34 shares for every share of common stock if the shares were subject to an award other than a stock option or stock appreciation right. Under the 2015 Plan, the purchase price of shares of common stock covered by a stock option cannot be less than 100% of the fair market value of the common stock on the date the stock option is granted. Fair market value of the common stock is generally equal to the closing price for the common stock on the principal securities exchange on which the common stock is traded on the date the stock option is granted (or if there was no closing price on that date, on the last preceding date on which a closing price was reported). Stock Options and Restricted Stock Units The Company values stock options using the Black-Scholes option-pricing model, which requires the input of subjective assumptions, including the risk-free interest rate, expected life, expected stock price volatility and dividend yield. The risk-free interest rate assumption is based upon observed interest rates for constant maturity U.S. Treasury securities consistent with the expected term of the Company’s employee stock options. The expected life represents the period of time the stock options are expected to be outstanding and is based on the simplified method. The Company uses the simplified method due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected life of the stock options. Expected volatility is based on historical volatilities for publicly traded stock of comparable companies over the estimated expected life of the stock options. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends. The valuation of stock options is also impacted by the valuation of common stock. Stock option awards generally have ten-year contractual terms and vest over four years for issuances to employees based on continuous service; however, the 2015 Plan allows for other vesting periods. The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31: 2017 2016 Risk-free interest rate 2.08% - 2.24% 1.49% - 2.31% Expected term (years) 7.05 6.00 - 6.25 Expected volatility 80% - 81% 50% - 63% Dividend yield 0% 0% The following table summarizes the assumptions used for estimating the fair value of stock options granted to non-employees for the year ended December 31: 2017 2016 Risk-free interest rate 1.97% - 2.39% 2.31% - 2.38% Expected term (years) 7.05 - 9.82 9.57 - 9.76 Expected volatility 80% 63% Dividend yield 0% 0% C. Stock-Based Award Activity The following tables provides a summary of stock option activity for employees and non-employees for the 2008 Plan and 2015 Plan (the “Plans”) and Restricted Stock Unit (“RSU’s”) activity for the year ended December 31, 2017, after giving effect of the Reverse Stock Split and Exchange Ratio: Stock Options: Shares Underlying Option Awards Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life Aggregate Intrinsic Value (in 000's) Outstanding at December 31, 2016 2,129,856 $ 7.98 8.54 $ — Granted 375,614 12.58 7.12 — Exercised (124,061 ) 1.31 — — Expired/cancelled/forfeited (464,577 ) 32.31 — — Outstanding at December 31, 2017 1,916,832 $ 3.47 7.89 $ 22,504 Options Exercisable at December 31,2017 863,001 $ 1.12 6.52 $ 12,157 Vested and expected to vest at December 31, 2017 1,916,832 $ 3.47 7.89 $ 22,504 RSU’s: Shares Underlying Option Awards Weighted-Average Grant Date Fair Value Outstanding at December 31, 2016 — $ — Granted 162,588 8.26 Exercised (75,486 ) 9.61 Expired/cancelled/forfeited (227 ) 9.80 Outstanding at December 31, 2017 86,875 $ 7.08 The following table provides a summary of options issued to employees and non-employees that are outstanding and vested as of December 31, 2017: Exercise Price Number Outstanding Weighted Average Life (in Years) Number Exercisable Weighted Average Life (in Years) $ 0.19 22,854 1.14 22,854 1.14 $ 0.31 7 1.95 7 1.95 $ 0.52 50,650 3.09 50,650 3.09 $ 0.55 35,160 3.95 35,160 3.95 $ 0.65 281,147 5.43 256,862 5.56 $ 0.82 101,378 6.00 101,378 6.00 $ 1.46 445,360 7.97 225,118 7.97 $ 1.51 127,578 8.82 31,894 8.82 $ 1.76 494,584 8.96 126,890 8.96 $ 5.13 7,500 9.40 7,500 9.40 $ 5.85 17,500 2.68 3,438 8.16 $ 8.70 90,000 9.64 1,250 9.80 $ 15.21 243,114 9.97 — 9.97 1,916,832 863,001 The weighted average grant date fair values for the Company’s stock options granted during the years ended December 31, 2017 and 2016 were $9.11 per share and $1.67 per share, respectively. The total compensation cost related to non-vested stock options not yet recognized as of December 31, 2017 was $4.0 million, which will be recognized over a weighted average period of approximately 3.81 years. 124,061 and 823 stock options were exercised during the years ended December 31, 2017 and 2016, respectively. During the year ended December 31, 2017, the Company granted options to purchase a total of 10,000 shares of common stock to non-employees under the 2015 Plan. The Company recorded stock-based compensation expense for options issued to non-employees of $30,640, $3,400 and $4,000 for the years ended December 31, 2017, 2016 and 2015, respectively. As of December 31, 2017, 5,713 non-employee options were vested and outstanding. D. Stock-Based Compensation Stock-based compensation expense is included in the following line items in the accompanying statements of operations and comprehensive loss for the years ended December 31, 2017, 2016, and 2015 (in thousands): Year ended December 31, 2017 2016 2015 Research and development $ 207 $ 93 $ 69 General and administrative 345 116 84 Total stock-based compensation $ 552 $ 209 $ 153 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 17. Income Taxes The components of loss before income taxes for the years ended December 31, 2017, 2016, and 2015 are as follows (in thousands) 2017 2016 2015 Domestic $ (21,942 ) $ (8,502 ) $ (8,999 ) Foreign (11,489 ) (2,778 ) — Total $ (33,431 ) $ (11,280 ) $ (8,999 ) The Company recorded a federal tax benefit of $2.8 million for income tax related to a rate reduction on a deferred tax liability for the year ended December 31, 2017 and no federal tax provision for income tax for the years ended December 31, 2016 and 2015 due to the reported net losses. The Company recorded no state provision for income taxes for the years ended December 31, 2017, 2016, and 2015, due to revenues below the minimum tax threshold. The Company recorded a foreign current income tax benefit related to the refundable research credit. The components of the provision (benefit) for income taxes are as follows for the years ended December 31, 2017, 2016, and 2015 (in thousands): 2017 2016 2015 Current: Federal $ — $ — $ — State — — — Foreign (814 ) (357 ) — Total Current (814 ) (357 ) — Deferred: Federal (2,820 ) — — State — — — Foreign — — — Total Deferred (2,820 ) — — Total Income tax expense (benefit) $ (3,634 ) $ (357 ) $ — A reconciliation of the expected income tax expense (benefit) computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2017, 2016, and 2015 (in thousands): 2017 2016 2015 Income Tax Expense (Benefit) Computed at Federal Statutory Tax Rate $ (11,367 ) $ (3,835 ) $ (3,059 ) Change in Valuation Allowance 1,487 4,009 3,488 Orphan Drug & Research Credits Generated (3,427 ) (2,435 ) (1,983 ) Orphan Drug & Research Credit Expense Disallowance 1,691 1,126 674 State Research Credits Generated, net of Federal Benefit — — (175 ) Contingent Liability 762 — — Impact of Foreign Operations 1,363 333 — Note Conversion 618 — — Change in Tax Rate Due to the 2017 Tax Act 4,096 — — Transaction Costs 657 — — Interest on Convertible Debt — — 867 Other Permanent Differences 486 445 188 Total (3,634 ) (357 ) — Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company has established a valuation allowance due to uncertainties regarding the realization of deferred tax assets based upon the Company’s lack of earnings history. During the years ended December 31, 2017 and December 31, 2016, the valuation allowance increased by $7.9 million and $4.0 million, respectively. Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2017 2016 Deferred Tax Liabilities: Stock-based Compensation $ — $ 2 Depreciation 87 257 Prepaid Assets 378 — Intangible Assets 7,181 2,305 Total Deferred Tax Liabilities 7,646 2,564 Deferred Tax Assets: Net Operating Loss Carryforwards 13,194 7,483 Amortization 6 11 Credit Carryforwards 9,770 7,241 Charitable Contributions — — Accrued Liabilities & Other 345 455 Total Deferred Tax Assets 23,315 15,190 Subtotal 15,669 12,626 Valuation Allowance (22,850 ) (14,931 ) Net Deferred Taxes $ (7,181 ) $ (2,305 ) On December 22, 2017, the 2017 Tax Act was signed into law making significant changes to the Internal Revenue Code. The legislation significantly changes U.S. tax law by, among other things, lowering corporate income tax rates from a maximum of 35% to a flat 21% rate and reducing the orphan drug credit from 50% to 25% of qualifying expenditures, effective for tax years beginning after December 31, 2017. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. As a result of the reduction in the U.S. corporate income tax rate under the 2017 Tax Act, the Company revalued its deferred tax assets and liabilities as of December 31, 2017 resulting in a net income tax benefit of 2.8 million. The accounting for the income tax effects of the 2017 Tax Act and related adjustments are reflected as provisional amounts in the financial statements as of and for the year ended December 31, 2017. Given the significant risk associated with the completion and commercialization of the Company’s products that will be derived from the indefinite lived in-process research and development asset, management is not considering the corresponding deferred tax liability as a source of income for purposes of its valuation allowance due to the uncertainty of if and when this temporary difference would ever reverse. As of December 31, 2017 and 2016, the Company had net operating loss (“NOL”) carryforwards for federal income tax purposes of approximately $52.8 million and $21.7 million, respectively. The Company also had available research and orphan drug tax credit carryforwards for federal income tax purposes of approximately $9.7 million and $7.2 million, respectively. If not utilized, these carryforwards expire at various dates beginning in 2028. As of December 31, 2017 and 2016, the Company had state research and development tax credit carryforwards of approximately $143,000 and $69,000, respectively, which will begin to expire in 2034 if not utilized. As of December 31, 2017 and 2016, the Company had foreign NOL carryforwards of approximately $9.5 million and $0.4 million, respectively, which have an indefinite carryforward period. Utilization of the NOL and tax credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future, as provided by Section 382 of the Internal Revenue Code of 1986 (“Section 382”), as well as similar state provisions. Ownership changes may limit the amount of NOL carryforwards and tax credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions that increase the ownership of 5% shareholders in the stock of a corporation by more than 50 percentage points in the aggregate over a three-year period. The Company has not performed a study to determine whether any ownership change has occurred since the Company’s formation through December 31, 2017. However, the Company believes that it has experienced at least two ownership changes in the past and that it may experience additional ownership changes as a result of subsequent shifts in its stock ownership. Should there be an ownership change that has occurred or will occur, the Company’s ability to utilize existing carryforwards could be substantially restricted and may result in the expiration of such carryforwards prior to utilization. The Company applies the accounting guidance in ASC 740 related to accounting for uncertainty in income taxes. The Company’s reserves related to taxes are based on a determination of whether, and how much of, a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. As of December 31, 2017 and 2016, the Company had no unrecognized tax benefits. During the years ended December 31, 2017 and 2016, the Company had no interest and penalties related to income taxes. The Company files income tax returns in the U.S. federal, state, and foreign jurisdictions. As of December 31, 2017, the statute of limitations for assessment by the Internal Revenue Service (“IRS”) is open for the 2014 and subsequent tax years, although carryforward attributes that were generated for tax years prior to then may still be adjusted upon examination by the IRS if they either have been, or will be, used in a future period. The 2013 and subsequent tax years remain open and subject to examination by the state taxing authorities. The 2016 and subsequent tax years remain open and subject to examination by the foreign taxing authorities. There are currently no federal, state, or foreign income tax audits in progress. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 18. Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted net loss per share is the same as basic net loss per common share, since the effects of potentially dilutive securities are antidilutive. As of December 31, 2017, 2016, and 2015 potentially dilutive securities include: Year ended December 31, 2017 2016 2015 Awards under equity incentive plan 1,916,832 1,814,645 1,079,679 Unvested restricted shares 103,065 108,411 180,813 Series A Contingent Redeemable Preferred Stock — 1,054,744 1,054,744 Series B Contingent Redeemable Preferred Stock — 3,325,776 3,325,776 Series C Contingent Redeemable Preferred Stock — 2,653,726 2,407,107 2016 Series C Convertible Note — 634,050 — Warrants to purchase Series B Contingent Redeemable Preferred Stock — 169,920 169,920 Warrants to purchase Series C Contingent Redeemable Preferred Stock — 74,992 — Warrants to purchase common stock 2,068,684 — — Total 4,088,581 9,836,264 8,218,039 The following table reconciles basic earnings per share of common stock to diluted earnings per share of common stock for the years ended December 31, 2017, 2016, and 2015. Year ending December 31, 2017 2016 2015 Net loss $ (29,797 ) $ (10,923 ) $ (8,999 ) Accretion of convertible redeemable preferred stock (578 ) (94 ) (183 ) Deemed dividend on beneficial conversion feature (404 ) — — Net loss attributable to common stockholders (30,779 ) (11,017 ) (9,182 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (30,779 ) (11,017 ) (9,182 ) Weighted average common shares outstanding, basic and diluted 17,521,119 1,960,490 968,810 Basic and diluted EPS $ (1.76 ) $ (5.62 ) $ (9.48 ) |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (Unaudited) | 19. Quarterly Financial Data (Unaudited) The following table summarizes unaudited quarterly financial data for the years ended December 31, 2017 and 2016 (in thousands, except per share data). 2017 First Second Third Fourth Quarter Quarter Quarter Quarter Revenues $ — $ — $ — $ — Operating loss $ (4,774 ) $ (9,343 ) $ (6,543 ) $ (9,296 ) Net loss $ (4,974 ) $ (11,504 ) $ (6,817 ) $ (6,502 ) Basic and diluted net loss per share $ (0.97 ) $ (0.90 ) $ (0.28 ) $ (0.23 ) 2016 First Second Third Fourth Quarter Quarter Quarter Quarter Revenues $ — $ — $ — $ 400 Operating loss $ (1,691 ) $ (1,983 ) $ (3,230 ) $ (4,044 ) Net loss $ (1,676 ) $ (2,051 ) $ (3,227 ) $ (3,969 ) Basic and diluted net loss per share $ (0.97 ) $ (1.97 ) $ (1.21 ) $ (1.31 ) |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 20. Subsequent Events Subsequent to year end, we received topline results on the Aironite study indicating that it did not meet its primary and secondary endpoints. Given the results, we do not plan to support any new development of Aironite. The study results are a triggering event in the first quarter of 2018 pursuant to which we shall perform a qualitative and quantitative impairment analysis of the related In-process R&D attributed to the Aironite product acquired in the Merger. |
Summary of Significant Accoun27
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (“FASB”). Certain prior year amounts have been reclassified for consistency with the current period presentation. |
Liquidity | Liquidity As of December 31, 2017, the Company had an accumulated deficit of approximately $68.2 million. The Company also used cash from operations of approximately $28.2 million for the year ended December 31, 2017. The cost to further develop and obtain regulatory approval for any drug is substantial and, as noted below, the Company may have to take certain steps to maintain a positive cash position. Accordingly, the Company will need additional capital to further fund the development of, and seek regulatory approvals for, its product candidates and begin to commercialize any approved products. The Company is currently focused primarily on the development of respiratory drugs and believes such activities will result in the Company’s continued incurrence of significant research and development and other expenses related to those programs. If the clinical trials for any of the Company’s product candidates fail or produce unsuccessful results and those product candidates do not gain regulatory approval, or if any of the Company’s product candidates, if approved, fail to achieve market acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expenses through cash and cash equivalents on hand and through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. While the Company had cash and cash equivalents of $22.1 million and short-term investments of $72.2 million as of December 31, 2017, we intend to continue to raise additional capital as needed through the issuance of additional equity and potentially through borrowings, and strategic alliances with partner companies. However, if such financings are not available timely and at adequate levels, the Company will need to reevaluate its operating plans. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars and are prepared using U.S. GAAP. These financial statements include the accounts of the Company and its wholly owned subsidiaries. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Income. All intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development costs, the valuation of preferred and common shares, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates. |
Risks and Uncertainties | Risks and Uncertainties The product candidates being developed by the Company require approvals from the U.S. Food and Drug Administration (FDA) or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company’s product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value. |
Grants and Award Receivables | Grants and Award Receivables Receivables arise from incurring allowable costs under federal grants or through the achievement of milestones under an award from a non-profit organization that have not been received as of the balance sheet dates. Since inception, the Company has never incurred losses on its grants and award receivable. The Company has no allowance for doubtful accounts as of December 31, 2016 as grants recievable were collected in full in 2017. No grant revenue or grants receivable were recognized in 2017. As such, the Company has no allowance for doubtful accounts as of December 31, 2017. |
Short-term Investments | Short-term Investments The Company has classified its investments in debt securities and equity securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments, net of taxes, reflected as a part of “Accumulated other comprehensive income (loss)” within stockholders' equity. The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Investments in debt securities are considered to be impaired when a decline in fair value is judged to be other than temporary because the Company either intends to sell or it is more-likely-than not that it will have to sell the impaired security before recovery. Once a decline in fair value is determined to be other than temporary, an impairment charge is recorded and a new cost basis in the investment is established. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents and foreign exchange derivatives not designated as hedging. The Company places its cash and cash equivalents with a limited number of high quality financial institutions and at times may exceed the amount of insurance provided on such deposits. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records the costs associated with research nonclinical studies, clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third-party service providers, including contract research and manufacturing organizations. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the study duration, may vary from the Company’s estimates resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. The Company has not experienced any material deviations between accrued and actual research and development expenses. |
Business Combinations | Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of purchase price over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on all available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. |
Goodwill and Acquired In-Process Research and Development (IPR&D) | Goodwill and Acquired In-Process Research and Development (IPR&D) Goodwill and acquired IPR&D are not amortized but are tested annually for impairment or more frequently if impairment indicators exist. The Company adopted accounting guidance related to annual and interim goodwill and acquired IPR&D impairment tests which allows the Company to first assess qualitative factors before performing a quantitative assessment of the fair value of a reporting unit. If it is determined on the basis of qualitative factors that the fair value of the reporting unit is more likely than not less than the carrying amount, a quantitative impairment test is required. During the year ended December 31, 2017, the Company experienced a $0.4 million and $1.5 million increase in the carrying value of goodwill and IPR&D, respectively, related to its acquisition of Savara ApS, which was due to foreign currency translation. Additional goodwill and IPR&D were recorded with respect to the Merger. |
Tax Refund Receivable | Tax Refund Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, for the post-acquisition period in 2016 and year ended December 31, 2017. Under Danish Tax Law, Denmark remits a research and development tax credit equal to 22% of qualified research and development expenditures, not to exceed established thresholds and offsets future taxable income. As of December 31, 2017, credits totaling $0.8 million is not due to be received until November 2018. The portion of the total Danish tax credit related to the post-acquisition period in 2016 of approximately $0.4 million was collected in November 2017. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. Our chief operating decision maker is the chief executive officer. We have one operating segment, specialty pharmaceuticals within the respiratory system. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: • Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. Financial instruments carried at fair value include cash and cash equivalents and contingent consideration related to the acquisition of Serendex for which any change is reflected in general and administrative expense, foreign exchange derivatives, and certain warrants classified as liabilities and embedded put options separated from the convertible promissory notes which were converted to common equity or derecognized on April 27, 2017 as a result of the Merger (Notes 8 and 10). Financial instruments not carried at fair value include accounts payable and accrued liabilities. The carrying amounts of these financial instruments approximate fair value due to the highly liquid nature of these short-term instruments. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which range from three to five years. Repairs and maintenance that do not improve or extend the useful life of the respective asset are charged to expense as incurred. |
Equipment under Capital Lease | Equipment under Capital Lease In 2015, the Company entered into a contract manufacturing arrangement that included the right to use specified equipment. Management concluded that the contract manufacturing arrangement contains an embedded lease of the specified equipment based on the facts and circumstances, including the Company’s ability to direct the use of the equipment and because management believes that it is remote that any party other than the Company will take more than a minor output produced by the equipment during the term of the arrangement. Management performed an analysis under ASC 840 to determine the proper accounting for the embedded lease and concluded that there is a capital lease because the present value of the minimum lease payments per the contract exceeds 90% of the fair value of the equipment. The capitalized equipment is depreciated on a straight-line basis over the lesser of the non-cancellable lease term or the useful life, and the lease obligation accrues interest at the incremental rate used in the present value analysis. |
Convertible Debt Issuance Costs | Convertible Debt Issuance Costs Convertible debt issuance costs are presented on the balance sheets as a direct deduction from the carrying amount of the debt liability. Convertible debt issuance costs incurred in the years ended December 31, 2017 and 2016 were not material. |
Patents and Intellectual Property | Patents and Intellectual Property The Company currently expenses all patent application costs. As the Company’s products are currently under research and development and are not currently approved for market, costs incurred in connection with patent applications are expensed as incurred due to the uncertainty of the future economic benefits of the underlying patents and intellectual property. |
Revenue Recognition | Revenue Recognition To date, the Company has recognized revenue solely from federal grants under the Small Business Innovation Research Program of the Department of Health and Human Services, National Institutes of Health (“NIH”, together the “Federal Grants”) and an award from the Cystic Fibrosis Foundation Therapeutics, Inc. (the “CFFT”), a non-profit organization (the “CFF Award”) as further described in Note 13. The Company has not generated any product revenue to date. The Company’s ability to generate product revenues, which the Company does not expect will occur for many years, if ever, will depend heavily on the successful development, regulatory approval and eventual commercialization of the Company’s product candidates. The Company records revenue related to the Federal Grants as qualifying costs are incurred, and when there is reasonable assurance that the conditions of the grant have been met and the grant will be received. The Company records revenue related to the CFF Award upon completion and achievement of defined milestones, and when there is reasonable assurance that the conditions of the award have been met and collectability is reasonably assured. |
Net Loss per Share | Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. |
Redeemable Convertible Preferred Stock and Series B and Series C Warrants | Redeemable Convertible Preferred Stock and Series B and Series C Warrants The Series A, Series B, and Series C redeemable convertible preferred stock, previously classified in temporary equity as it was redeemable at the written request of the holders of at least two-thirds of the then outstanding shares of preferred stock, at any time after October 31, 2022, was converted to common stock on the effective date of the Merger subject to the Exchange Ratio. Additionally, certain outstanding warrants to purchase Series B convertible preferred stock (“Series B Warrants”) previously classified as liabilities were exercised on the effective date of the Merger with any residual Series B warrants expiring in May 2017. Certain outstanding warrants to purchase Series C redeemable convertible preferred stock (“Series C Warrants”) were reclassified from a liability to common equity as the Series C Warrants have been converted to warrants to purchase common stock subject to the Exchange Ratio following the Merger. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period (see Note 16). Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. The Company recognizes the cost of stock-based awards granted to nonemployees at their then-current fair values as services are performed, and such awards are remeasured through the counterparty performance date. |
Manufacturing Commitments and Contingencies | Manufacturing Commitments and Contingencies The Company is subject to various manufacturing royalties and payments related to its product candidate, Molgradex. Under an agreement, as amended, with the Active Pharmaceutical Ingredients (“API”) manufacturer, no signing fee or milestones are included in the royalty payments, and there is no minimum royalty. Upon the successful development, registration and attainment of approval by the proper health authorities, such as the FDA, in any territory except Latin America, Central America and Mexico, the Company must pay a royalty of three percent (3%) on annual net sales to the manufacturer of its API. Additionally, Savara must make certain payments to the API manufacturer upon the achievement of the milestones outlined in the following table. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the Company’s manufacturer of its nebulizer used to administer Molgradex. In addition to these milestones, the Company will owe a royalty to the manufacturer of its nebulizer based on net sales. The royalty rate ranges from three and a half percent (3.5%) to five percent (5%) depending on the device technology used by the Company to administer the product. Manufacturing Contingent Milestone Payments (in thousands) : December 31, 2017 Molgradex API manufacturer: Delivery of working and master cell banks $ 600 Achievement of certain milestones related to regulatory approval of Molgradex 2,000 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 8,330 Total manufacturing commitments $ 10,930 As of December 31, 2017 and 2016, none of the above milestones had been met. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more likely than not to be realized. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers and has subsequently issued several supplemental and/or clarifying ASUs, which comprise the new comprehensive revenue recognition standard that will replace all current GAAP guidance on this topic and eliminate all industry-specific guidance. The standard’s core principle is that a reporting entity will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. We have performed an assessment of our contracts with third parties and determined that they would not have a material impact on our financial statements. In February 2016, the FASB issued Accounting Standards Update 2016-02, “Leases” (“ASU 2016-02”). The update aims at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet as a right-of-use asset and a corresponding lease liability, including leases currently accounted for as operating leases. The update also requires improved disclosures to help users of financial statements better understand the amount, timing and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 with early adoption permitted. The Company is currently evaluating the impact of the adoption of ASU 2016-02 on its financial statements. In August 2016, the FASB issued Accounting Standards Update 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”), which intended to add or clarify guidance on the classification of certain cash receipts and payments on the statement of cash flows. The new guidance addresses cash flows related to the following: debt prepayment or extinguishment costs, settlement of zero coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies and bank-owned life insurance policies, distributions received from equity method investees, beneficial interest in securitization transactions, and the application of predominance principle to separately identifiable cash flows. ASU 2016-15 is effective for the Company for annual periods beginning after December 15, 2017 with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its financial statements. In January 2017, the FASB issued Accounting Standards Update 2017-01, “Business Combinations (Topic 805): Clarifying the Definition of a Business” (“ASU 2017-01”), which intended to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. ASU 2017-01 is effective for the Company for annual periods beginning after December 15, 2017 with early adoption permitted. The Company is currently evaluating the effect of this new guidance on its financial statements. |
Summary of Significant Accoun28
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Manufacturing Contingent Milestone Payments | The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the Company’s manufacturer of its nebulizer used to administer Molgradex. In addition to these milestones, the Company will owe a royalty to the manufacturer of its nebulizer based on net sales. The royalty rate ranges from three and a half percent (3.5%) to five percent (5%) depending on the device technology used by the Company to administer the product. Manufacturing Contingent Milestone Payments (in thousands) : December 31, 2017 Molgradex API manufacturer: Delivery of working and master cell banks $ 600 Achievement of certain milestones related to regulatory approval of Molgradex 2,000 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 8,330 Total manufacturing commitments $ 10,930 |
Prepaid Expenses and Other Cu29
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses, consisted of (in thousands): December 31, 2017 2016 R&D tax credit receivable $ 834 $ 357 Prepaid clinical trial costs 2,129 243 VAT receivable 196 111 Prepaid insurance 158 35 Forward currency exchange derivative 40 — Deposits and other 194 94 Total prepaid expenses and other current assets $ 3,551 $ 840 |
Accrued Expenses and Other Li30
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities, consisted of (in thousands): December 31, 2017 2016 Accrued contracted research and development costs $ 1,308 $ 1,855 Accrued general and administrative costs 323 458 Accrued compensation 1,328 117 Other 7 47 Total accrued expenses and other liabilities $ 2,966 $ 2,477 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Major Security Type of Investments | The following table summarizes, by major security type, the Company’s investments as of December 31, 2017 (in thousands): Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 11,894 $ — $ (9 ) $ 11,885 Asset backed securities 8,389 — (6 ) 8,383 Corporate securities 22,113 — (31 ) 22,082 Commercial paper 29,842 — — 29,842 Total short-term investments $ 72,238 $ — $ (46 ) $ 72,192 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net consisted of (in thousands): 2017 2016 Research and development equipment under capital lease $ 1,102 $ 1,102 Equipment 674 177 Furniture and fixtures — 18 Total property and equipment 1,776 1,297 Less accumulated depreciation (851 ) (504 ) Property and equipment, net 925 793 |
Acquisitions (Tables)
Acquisitions (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Mast [Member] | |
Summary of Purchase Price Allocation | The total purchase price for Mast was $35.8 million based on the fair value of the outstanding Mast equity on the date of the Merger which was allocated as follows: Purchase Consideration (in thousands) Fair value of Mast shares outstanding $ 33,117 Fair value of Mast equity 2,729 Fair value of total consideration $ 35,846 Assets acquired and liabilities assumed Cash and cash equivalents $ 3,442 Tangible assets 283 In-process research and development intangible assets 21,692 Liabilities (2,396 ) Debt (3,407 ) Deferred tax liability (7,375 ) Total assets acquired and liabilities assumed 12,239 Goodwill 23,607 Total $ 35,846 |
Pro forma Condensed Consolidated Financial Information | Included in the Savara consolidated statement of operations for the year ended December 31, 2017 is $0 of revenue and $1.6 million of net loss before income tax generated by Mast since April 27, 2017, the acquisition date. Year ending December 31, 2017 2016 Net revenues $ 94 $ 528 Net loss $ (20,420 ) $ (42,560 ) |
Serendex [Member] | |
Summary of Purchase Price Allocation | The following table summarizes the consideration that the Company paid for Serendex and the amounts of the assets acquired and liabilities assumed recognized at the acquisition date: Purchase Consideration (in thousands) Fair value of Savara common stock issued for the acquistion $ 2,851 Estimated fair value of Contingent Milestone Payments 9,524 Fair value of total consideration $ 12,375 Assets acquired and liabilities assumed Inventory $ 18 Income tax receivable 872 Propety and equipment, net 28 Current liabilities (320 ) Deferred tax liability (2,419 ) In-process research and development intangible asset 10,994 Total assets acquired and liabilities assumed 9,173 Goodwill 3,202 Total $ 12,375 |
Pro forma Condensed Consolidated Financial Information | Included in the Company’s consolidated Statement of Operations and Comprehensive Loss for the years ended December 31, 2017 and 2016 (since July 15 2016, the acquisition date) was $0 of revenue and $11.5 million and $2.8 million, respectively, of net loss before income tax generated by the Serendex (in thousands). Year ending December 31, 2017 2016 Net revenues $ — $ 400 Net loss $ (28,229 ) $ 17,748 |
Debt Facility (Tables)
Debt Facility (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Summary of Components of Debt Facility Carrying Value | The following table summarizes the components of the debt facility carrying value (in thousands): As of December 31, 2017 Short-term Long-term Principal payments to lender and end of term charge $ — $ 15,151 Debt Issuance costs — (83 ) Debt discount related to warrants — (293 ) Carrying Value $ — $ 14,775 |
Future Minimum Payments | Future minimum payments under the debt facility are as follows (in thousands): Year Ending December 31, 2018 $ — 2019 5,625 2020 7,500 2021 2,775 Total future minimum payments 15,900 Unamortized end of term charge (749 ) Debt issuance costs and debt discount (376 ) Total minimum payment 14,775 Short-term portion — Long-term debt facility $ 14,775 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Financial Instruments | The fair value of these instruments as of December 31, 2017 and 2016 was as follows (in thousands): Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2017: Cash equivalents: U.S. Treasury money market funds $ 4,540 $ — $ — U.S. government securities — — — Commercial paper — 1,029 — Repurchase agreements — 2,500 — Short-term investments: U.S. government securities $ 11,885 $ — $ — Asset backed securities — 8,383 — Corporate securities — 22,082 — Commercial paper — 29,842 — Other assets: Foreign exchange derivatives not designated as hedging instruments $ — $ 40 $ — Liabilities: Contingent consideration $ — $ — $ 11,948 As of December 31, 2016: Liabilities: Put option $ — $ — $ 979 Warrant liability — — 303 Contingent consideration — — 9,708 |
Summary of Assumptions Used to Value Put Option on 2016 Notes and 2017 Notes | The estimated fair value of the put option on the 2016 Notes was determined using a multi-scenario probability weighted average method analysis in which the future probability of the equity financing event or Merger was weighted for its respective probability. The Company used the following assumptions to value the put option on the 2016 Notes and 2017 Notes as of December 31, 2017 and 2016. Upon the Merger date of April 27, 2017, the 2016 Notes and 2017 Notes were automatically converted into shares of common stock of the Company Assumption December 31, 2017 December 31, 2016 Discount rate — 0.43 % Probability of event — 85.0 % |
Summary of Assumptions Used in Valuing Warrants | The assumptions used in valuing these warrants are presented in the table below. The warrant liability was reclassified as common equity upon the Merger date Assumption December 31, 2017 December 31, 2016 Expected term — 0.42 – 4.50 Expected dividend yield — — Expected volatility — 44.65% - Risk-free interest rate — 0.58% - 1.82% |
Summary of Changes in Fair Value of Company's Level 3 Financial Instrument | The following tables sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instrument (in thousands) for the year ended December 31, 2017 and 2016: Warrant Liability Put Option on 2016 Note and 2017 Note Contingent Consideration As of December 31, 2015 $ 274 $ — $ — Put option at issuance of 2016 Notes — 977 — Contingent consideration — — 9,524 Issuance of Series C Warrants 259 — — Change in fair value (230 ) 2 184 Balance at December 31, 2016 $ 303 $ 979 $ 9,708 Change in fair value 67 169 2,240 Put option at issuance of 2017 Notes — 828 — Reclassification of warrant liability to common equity (370 ) — — Conversion of 2016 and 2017 Notes — (1,976 ) — Balance at December 31, 2017 $ — $ — $ 11,948 |
Shareholders_ Equity (Tables)
Shareholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Summary of Company’s Common Stock | The following is a summary of the Company’s common stock at December 31, 2017 and 2016. December 31, 2017 December 31, 2016 Common stock authorized 500,000,000 27,000,000 Common stock outstanding 30,509,522 3,162,573 |
Company’s Shares of Common Stock Reserved for Issuance | The Company’s shares of common stock reserved for issuance as of December 31, 2017 and 2016 were as follows: December 31, 2017 December 31, 2016 Series A Preferred Stock — 1,799,906 Series B Preferred Stock — 5,675,387 Series C Preferred Stock — 4,452,582 Series B Warrants — 289,966 Series C Warrants — 125,885 Warrants from Mast acquired in Merger 1,152,231 — Warrants Converted Pursuant to Merger 74,992 — April 2017 SVB Warrants 24,725 — June 2017 SVB Warrants 41,736 — Prefunded warrants 775,000 — Stock options outstanding 1,916,832 1,814,645 Issued and unvested RSU's 86,875 — Total shares reserved 4,072,391 14,158,371 |
Summary of Outstanding Preferred Stock | The following table discloses the outstanding preferred stock immediately prior to the Merger. Par Value Shares Authorized Shares Outstanding Carry Value Liquidation Amount Series A $.001 1,799,906 1,799,906 $ 3,232 $ 3,254 Series B $.001 6,000,000 5,675,387 $ 17,301 $ 17,762 Series C $.001 8,000,000 4,452,582 $ 23,328 $ 23,423 Total 15,799,906 11,927,875 $ 43,861 $ 44,439 |
Summary of Outstanding Warrants for Company’s Common Stock | The following table summarizes the outstanding warrants for the Company’s common stock as of December 31, 2017: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 401,391 $ 45.50 June 2018 314,446 $ 52.50 November 2019 32,467 $ 7.00 August 2020 403,927 $ 29.40 February 2021 74,992 $ 8.98 June 2021 24,725 $ 9.10 April 2027 41,736 $ 5.39 June 2027 775,000 $ 0.01 October 2024 2,068,684 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Annual Lease Payments Under Operating Leases | The future minimum annual lease payments under the operating leases are as follows (in thousands) Year Ending December 31, 2018 822 2019 831 2020 396 2021 97 2,146 |
Future Minimum Annual Lease Payments Under Capital Lease | The future minimum annual lease payments under the capital lease are as follows (in thousands) Year Ending December 31, 2018 $ 292 2019 301 Total minimum lease payments $ 593 Less: imputed interest (31 ) Total capital lease obligation $ 562 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Restricted Share Activity | The following table summarizes the restricted share activity for the years ended December 31, 2017 and 2016: Restricted Shares Weighted-Average Grant Date Fair Value Nonvested at December 31, 2015 180,813 $ 0.75 Granted — — Vested (72,402 ) $ 0.73 Forfeited — — Nonvested at December 31, 2016 108,411 $ 0.69 Granted — — Vested (73,176 ) 0.74 Forfeited (19,045 ) 0.5 Nonvested at December 31, 2017 16,190 $ 0.65 |
Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted to Employees and Non-Employees | The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31: 2017 2016 Risk-free interest rate 2.08% - 2.24% 1.49% - 2.31% Expected term (years) 7.05 6.00 - 6.25 Expected volatility 80% - 81% 50% - 63% Dividend yield 0% 0% The following table summarizes the assumptions used for estimating the fair value of stock options granted to non-employees for the year ended December 31: 2017 2016 Risk-free interest rate 1.97% - 2.39% 2.31% - 2.38% Expected term (years) 7.05 - 9.82 9.57 - 9.76 Expected volatility 80% 63% Dividend yield 0% 0% |
Summary of Stock Option Activity and Restricted Stock Unit Activity After Giving Effect of Reverse Stock Split and Exchange Ratio | The following tables provides a summary of stock option activity for employees and non-employees for the 2008 Plan and 2015 Plan (the “Plans”) and Restricted Stock Unit (“RSU’s”) activity for the year ended December 31, 2017, after giving effect of the Reverse Stock Split and Exchange Ratio: Stock Options: Shares Underlying Option Awards Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life Aggregate Intrinsic Value (in 000's) Outstanding at December 31, 2016 2,129,856 $ 7.98 8.54 $ — Granted 375,614 12.58 7.12 — Exercised (124,061 ) 1.31 — — Expired/cancelled/forfeited (464,577 ) 32.31 — — Outstanding at December 31, 2017 1,916,832 $ 3.47 7.89 $ 22,504 Options Exercisable at December 31,2017 863,001 $ 1.12 6.52 $ 12,157 Vested and expected to vest at December 31, 2017 1,916,832 $ 3.47 7.89 $ 22,504 RSU’s: Shares Underlying Option Awards Weighted-Average Grant Date Fair Value Outstanding at December 31, 2016 — $ — Granted 162,588 8.26 Exercised (75,486 ) 9.61 Expired/cancelled/forfeited (227 ) 9.80 Outstanding at December 31, 2017 86,875 $ 7.08 |
Summary of Options Issued to Employees and Non-employees that are Outstanding and Vested | The following table provides a summary of options issued to employees and non-employees that are outstanding and vested as of December 31, 2017: Exercise Price Number Outstanding Weighted Average Life (in Years) Number Exercisable Weighted Average Life (in Years) $ 0.19 22,854 1.14 22,854 1.14 $ 0.31 7 1.95 7 1.95 $ 0.52 50,650 3.09 50,650 3.09 $ 0.55 35,160 3.95 35,160 3.95 $ 0.65 281,147 5.43 256,862 5.56 $ 0.82 101,378 6.00 101,378 6.00 $ 1.46 445,360 7.97 225,118 7.97 $ 1.51 127,578 8.82 31,894 8.82 $ 1.76 494,584 8.96 126,890 8.96 $ 5.13 7,500 9.40 7,500 9.40 $ 5.85 17,500 2.68 3,438 8.16 $ 8.70 90,000 9.64 1,250 9.80 $ 15.21 243,114 9.97 — 9.97 1,916,832 863,001 |
Stock-based Compensation Expense included in Accompanying Statements of Operations and Comprehensive Loss | Stock-based compensation expense is included in the following line items in the accompanying statements of operations and comprehensive loss for the years ended December 31, 2017, 2016, and 2015 (in thousands): Year ended December 31, 2017 2016 2015 Research and development $ 207 $ 93 $ 69 General and administrative 345 116 84 Total stock-based compensation $ 552 $ 209 $ 153 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Components of Loss Before Income Taxes | The components of loss before income taxes for the years ended December 31, 2017, 2016, and 2015 are as follows (in thousands) 2017 2016 2015 Domestic $ (21,942 ) $ (8,502 ) $ (8,999 ) Foreign (11,489 ) (2,778 ) — Total $ (33,431 ) $ (11,280 ) $ (8,999 ) |
Components of Provision (Benefit) for Income Taxes | The components of the provision (benefit) for income taxes are as follows for the years ended December 31, 2017, 2016, and 2015 (in thousands): 2017 2016 2015 Current: Federal $ — $ — $ — State — — — Foreign (814 ) (357 ) — Total Current (814 ) (357 ) — Deferred: Federal (2,820 ) — — State — — — Foreign — — — Total Deferred (2,820 ) — — Total Income tax expense (benefit) $ (3,634 ) $ (357 ) $ — |
Reconciliation of Expected Income Tax Expense (Benefit) | A reconciliation of the expected income tax expense (benefit) computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2017, 2016, and 2015 (in thousands): 2017 2016 2015 Income Tax Expense (Benefit) Computed at Federal Statutory Tax Rate $ (11,367 ) $ (3,835 ) $ (3,059 ) Change in Valuation Allowance 1,487 4,009 3,488 Orphan Drug & Research Credits Generated (3,427 ) (2,435 ) (1,983 ) Orphan Drug & Research Credit Expense Disallowance 1,691 1,126 674 State Research Credits Generated, net of Federal Benefit — — (175 ) Contingent Liability 762 — — Impact of Foreign Operations 1,363 333 — Note Conversion 618 — — Change in Tax Rate Due to the 2017 Tax Act 4,096 — — Transaction Costs 657 — — Interest on Convertible Debt — — 867 Other Permanent Differences 486 445 188 Total (3,634 ) (357 ) — |
Significant Components of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2017 2016 Deferred Tax Liabilities: Stock-based Compensation $ — $ 2 Depreciation 87 257 Prepaid Assets 378 — Intangible Assets 7,181 2,305 Total Deferred Tax Liabilities 7,646 2,564 Deferred Tax Assets: Net Operating Loss Carryforwards 13,194 7,483 Amortization 6 11 Credit Carryforwards 9,770 7,241 Charitable Contributions — — Accrued Liabilities & Other 345 455 Total Deferred Tax Assets 23,315 15,190 Subtotal 15,669 12,626 Valuation Allowance (22,850 ) (14,931 ) Net Deferred Taxes $ (7,181 ) $ (2,305 ) |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities | As of December 31, 2017, 2016, and 2015 potentially dilutive securities include: Year ended December 31, 2017 2016 2015 Awards under equity incentive plan 1,916,832 1,814,645 1,079,679 Unvested restricted shares 103,065 108,411 180,813 Series A Contingent Redeemable Preferred Stock — 1,054,744 1,054,744 Series B Contingent Redeemable Preferred Stock — 3,325,776 3,325,776 Series C Contingent Redeemable Preferred Stock — 2,653,726 2,407,107 2016 Series C Convertible Note — 634,050 — Warrants to purchase Series B Contingent Redeemable Preferred Stock — 169,920 169,920 Warrants to purchase Series C Contingent Redeemable Preferred Stock — 74,992 — Warrants to purchase common stock 2,068,684 — — Total 4,088,581 9,836,264 8,218,039 |
Reconciles Basic Earnings Per Share and Diluted Earnings Per Share of Common Stock | The following table reconciles basic earnings per share of common stock to diluted earnings per share of common stock for the years ended December 31, 2017, 2016, and 2015. Year ending December 31, 2017 2016 2015 Net loss $ (29,797 ) $ (10,923 ) $ (8,999 ) Accretion of convertible redeemable preferred stock (578 ) (94 ) (183 ) Deemed dividend on beneficial conversion feature (404 ) — — Net loss attributable to common stockholders (30,779 ) (11,017 ) (9,182 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (30,779 ) (11,017 ) (9,182 ) Weighted average common shares outstanding, basic and diluted 17,521,119 1,960,490 968,810 Basic and diluted EPS $ (1.76 ) $ (5.62 ) $ (9.48 ) |
Quarterly Financial Data (Una41
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Quarterly Financial Data | The following table summarizes unaudited quarterly financial data for the years ended December 31, 2017 and 2016 (in thousands, except per share data). 2017 First Second Third Fourth Quarter Quarter Quarter Quarter Revenues $ — $ — $ — $ — Operating loss $ (4,774 ) $ (9,343 ) $ (6,543 ) $ (9,296 ) Net loss $ (4,974 ) $ (11,504 ) $ (6,817 ) $ (6,502 ) Basic and diluted net loss per share $ (0.97 ) $ (0.90 ) $ (0.28 ) $ (0.23 ) 2016 First Second Third Fourth Quarter Quarter Quarter Quarter Revenues $ — $ — $ — $ 400 Operating loss $ (1,691 ) $ (1,983 ) $ (3,230 ) $ (4,044 ) Net loss $ (1,676 ) $ (2,051 ) $ (3,227 ) $ (3,969 ) Basic and diluted net loss per share $ (0.97 ) $ (1.97 ) $ (1.21 ) $ (1.31 ) |
Description of Business and B42
Description of Business and Basis of Presentation - Additional Information (Detail) | Apr. 27, 2017 | Jan. 06, 2017 | Dec. 31, 2017USD ($)Segment |
Description Of Business And Basis Of Presentation [Line Items] | |||
Number of operating segments | Segment | 1 | ||
Product revenue from inception to date | $ | $ 0 | ||
Savara Inc. [Member] | |||
Description Of Business And Basis Of Presentation [Line Items] | |||
Percentage of shares owned by preexisting equity holders | 77.00% | ||
Mast [Member] | |||
Description Of Business And Basis Of Presentation [Line Items] | |||
Merger agreement, effective date | Jan. 6, 2017 | ||
Business combination completion date | Apr. 27, 2017 | ||
Exchange ratio for each one outstanding common stock under merger agreement | 0.5860 | ||
Reverse stock split ratio | 0.0142 | ||
Reverse stock split ratio, description | one new share for every 70 shares | ||
Percentage of shares owned by preexisting equity holders | 23.00% |
Summary of Significant Accoun43
Summary of Significant Accounting Policies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Nov. 30, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2017USD ($)Segment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||||
Accumulated deficit | $ (38,406,000) | $ (68,203,000) | $ (38,406,000) | |||
Cash from operations | (28,234,000) | (8,370,000) | $ (4,778,000) | |||
Cash and cash equivalents | 13,373,000 | 22,121,000 | 13,373,000 | 16,683,000 | $ 12,688,000 | |
Short-term investments | 0 | $ 72,192,000 | 0 | |||
Cash and cash equivalents with original maturities | three months or less | |||||
Allowance for doubtful accounts | 0 | $ 0 | 0 | |||
Grant revenue or grants receivable | $ 400,000 | $ 0 | $ 400,000 | $ 54,000 | ||
Number of operating segments | Segment | 1 | |||||
Percentage of present value of minimum lease payments per contract exceeding fair value of equipment determined lease as capital lease | 90.00% | |||||
Active Pharmaceutical Ingredients [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Minimum royalty payment | $ 0 | |||||
Amount of signing fee or milestones included in royalty payments | $ 0 | |||||
Agreement description | Under an agreement, as amended, with the Active Pharmaceutical Ingredients (“API”) manufacturer, no signing fee or milestones are included in the royalty payments, and there is no minimum royalty. | |||||
Royalty percent on net sale | 3.00% | |||||
Series A, Series B, and Series C Redeemable Convertible Preferred Stock [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Percentage of redeemable convertible preferred stock | 66.66% | |||||
Series B Warrants [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Warrants expiration | 2017-05 | |||||
Minimum [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Estimated useful lives of assets | 3 years | |||||
Minimum [Member] | Nebulizer [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Royalty percent on net sale | 3.50% | |||||
Maximum [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Estimated useful lives of assets | 5 years | |||||
Maximum [Member] | Nebulizer [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Royalty percent on net sale | 5.00% | |||||
Savara ApS [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Carrying value of goodwill | $ 400,000 | |||||
Carrying value of IPR&D | $ 1,500,000 | |||||
Research and development tax credits | 22.00% | |||||
Research and development tax credits receivable | $ 800,000 | |||||
Proceeds from collection of research and development tax credits | $ 400,000 |
Summary of Significant Accoun44
Summary of Significant Accounting Policies - Schedule of Manufacturing Contingent Milestone Payments (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |
Total manufacturing commitments | $ 10,930 |
Molgradex API Manufacturer [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Delivery of working and master cell banks | 600 |
Achievement of certain milestones related to regulatory approval of Molgradex | 2,000 |
Molgradex Nebulizer Manufacturer [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex | $ 8,330 |
Prepaid Expenses and Other Cu45
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Prepaid Expense And Other Assets Current [Abstract] | ||
R&D tax credit receivable | $ 834 | $ 357 |
Prepaid clinical trial costs | 2,129 | 243 |
VAT receivable | 196 | 111 |
Prepaid insurance | 158 | 35 |
Forward currency exchange derivative | 40 | |
Deposits and other | 194 | 94 |
Total prepaid expenses and other current assets | $ 3,551 | $ 840 |
Accrued Expenses and Other Li46
Accrued Expenses and Other Liabilities - Summary of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Payables And Accruals [Abstract] | ||
Accrued contracted research and development costs | $ 1,308 | $ 1,855 |
Accrued general and administrative costs | 323 | 458 |
Accrued compensation | 1,328 | 117 |
Other | 7 | 47 |
Total accrued expenses and other liabilities | $ 2,966 | $ 2,477 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Available For Sale Securities Gross Realized Gain Loss Net [Abstract] | |||
Short-term investments | $ 72,192,000 | $ 0 | |
Realized gains or losses on investments | $ 0 | $ 0 | $ 0 |
Short-term Investments - Summar
Short-term Investments - Summary of Major Security and Type of Investments (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | $ 72,238 |
Gross Unrealized Losses | (46) |
Fair Value | 72,192 |
U.S. Government Securities [Member] | |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | 11,894 |
Gross Unrealized Losses | (9) |
Fair Value | 11,885 |
Asset Backed Securities [Member] | |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | 8,389 |
Gross Unrealized Losses | (6) |
Fair Value | 8,383 |
Corporate Securities [Member] | |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | 22,113 |
Gross Unrealized Losses | (31) |
Fair Value | 22,082 |
Commercial Paper [Member] | |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | 29,842 |
Fair Value | $ 29,842 |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,776 | $ 1,297 |
Less accumulated depreciation | (851) | (504) |
Property and equipment, net | 925 | 793 |
Research and Development Equipment Under Capital Lease [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,102 | 1,102 |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 674 | 177 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 18 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Property Plant And Equipment [Line Items] | |||
Depreciation expense | $ 363 | $ 346 | $ 6 |
Accumulated amortization | 851 | $ 504 | |
Capitalized Leases [Member] | |||
Property Plant And Equipment [Line Items] | |||
Accumulated amortization | $ 700 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) - USD ($) | Apr. 27, 2017 | Jan. 06, 2017 | Jul. 15, 2016 | Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2017 |
Business Acquisition [Line Items] | ||||||||||
Revenue | $ 400,000 | $ 0 | $ 400,000 | $ 54,000 | ||||||
Net loss before income tax | 33,431,000 | 11,280,000 | $ 8,999,000 | |||||||
Mast [Member] | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Business combination completion date | Apr. 27, 2017 | |||||||||
Purchase price based on the fair value of outstanding equity | $ 35,846,000 | |||||||||
Reduction in deferred tax liability | (1,300,000) | |||||||||
Increase in carrying value of goodwill | 1,300,000 | |||||||||
Revenue | $ 0 | |||||||||
Net loss before income tax | 1,600,000 | |||||||||
Transaction costs | 8,500,000 | 600,000 | ||||||||
Reduction in interest expense repayment pre-merger debt | $ 1,400,000 | |||||||||
Merger agreement, effective date | Jan. 6, 2017 | |||||||||
Mast [Member] | General and Administrative Expense [Member] | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Transaction costs | $ 2,200,000 | $ 2,200,000 | $ 2,200,000 | |||||||
Serendex [Member] | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Business combination completion date | Jul. 15, 2016 | |||||||||
Purchase price based on the fair value of outstanding equity | $ 12,375,000 | |||||||||
Revenue | $ 0 | 0 | ||||||||
Net loss before income tax | $ 2,800,000 | $ 11,500,000 | ||||||||
Merger agreement, effective date | May 13, 2016 | |||||||||
Common stock shares issued | 1,965,400 | |||||||||
Serendex [Member] | Marketing Approval of Product by European Medicines Agency [Member] | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Business combination, contingent milestone payments | $ 5,000,000 | |||||||||
Serendex [Member] | Marketing Approval of Product by United States Food and Drug Administration [Member] | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Business combination, contingent milestone payments | 15,000,000 | |||||||||
Serendex [Member] | Marketing Approval of Product by Japanese Pharmaceuticals and Medical Devices Agency [Member] | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Business combination, contingent milestone payments | $ 1,500,000 |
Acquisitions - Summary of Purch
Acquisitions - Summary of Purchase Price Allocation - (Detail) - USD ($) $ in Thousands | Apr. 27, 2017 | Jul. 15, 2016 | Dec. 31, 2017 | Dec. 31, 2016 |
Assets acquired and liabilities assumed | ||||
Goodwill | $ 27,082 | $ 3,051 | ||
Mast [Member] | ||||
Business Acquisition [Line Items] | ||||
Fair value of Mast shares outstanding | $ 33,117 | |||
Fair value of Mast equity | 2,729 | |||
Fair value of total consideration | 35,846 | |||
Assets acquired and liabilities assumed | ||||
Cash and cash equivalents | 3,442 | |||
Tangible assets | 283 | |||
In-process research and development intangible assets | 21,692 | |||
Liabilities | (2,396) | |||
Debt | (3,407) | |||
Deferred tax liability | (7,375) | |||
Total assets acquired and liabilities assumed | 12,239 | |||
Goodwill | 23,607 | |||
Total | 35,846 | |||
Fair value of total consideration | $ 35,846 | |||
Serendex [Member] | ||||
Business Acquisition [Line Items] | ||||
Fair value of total consideration | $ 12,375 | |||
Assets acquired and liabilities assumed | ||||
Inventory | 18 | |||
Income tax receivable | 872 | |||
Propety and equipment, net | 28 | |||
In-process research and development intangible assets | 10,994 | |||
Liabilities | (320) | |||
Deferred tax liability | (2,419) | |||
Total assets acquired and liabilities assumed | 9,173 | |||
Goodwill | 3,202 | |||
Total | 12,375 | |||
Fair value of Savara common stock issued for the acquistion | 2,851 | |||
Estimated fair value of Contingent Milestone Payments | 9,524 | |||
Fair value of total consideration | $ 12,375 |
Acquisitions - Pro forma Conden
Acquisitions - Pro forma Condensed Consolidated Financial Information - (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Mast [Member] | ||
Business Acquisition [Line Items] | ||
Net revenues | $ 94 | $ 528 |
Net loss | (20,420) | (42,560) |
Serendex [Member] | ||
Business Acquisition [Line Items] | ||
Net revenues | 400 | |
Net loss | $ (28,229) | $ 17,748 |
Convertible Promissory Notes -
Convertible Promissory Notes - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2017USD ($)d | Dec. 31, 2016USD ($)d$ / shares | Dec. 31, 2015USD ($) | |
Debt Instrument [Line Items] | |||
Borrowed from convertible promissory note | $ 3,569,000 | $ 4,415,000 | |
Derivative liabilities, fair value | 2,600,000 | ||
Interest expense | 1,161,000 | 452,000 | $ 2,585,000 |
Loss on extinguishment of debt | $ 1,816,000 | $ 226,000 | |
2016 Notes [Member] | |||
Debt Instrument [Line Items] | |||
Borrowed from convertible promissory note | $ 4,400,000 | ||
Convertible promissory note, accrued interest | 8.00% | ||
Convertible promissory note, maturity date | Jun. 30, 2018 | ||
Loss on extinguishment of debt | $ 900,000 | ||
2016 Notes [Member] | Accretion of Total Discount [Member] | |||
Debt Instrument [Line Items] | |||
Interest expense | 200,000 | ||
2016 Notes [Member] | Put Option [Member] | |||
Debt Instrument [Line Items] | |||
Derivative liabilities, fair value | $ 1,000,000 | ||
2016 Notes [Member] | Series C Redeemable Convertible Preferred Stock [Member] | |||
Debt Instrument [Line Items] | |||
Description of change in control conversion | (i) a merger or consolidation of the Company into or with another entity after which the stockholders of the Company immediately prior to such transaction do not own, immediately following the consummation of the transaction by virtue of their shares in the Company or securities received in exchange for such shares in connection with the transaction, a majority of the voting power of the surviving entity in proportions substantially identical to those that existed immediately prior to such transaction and with substantially the same rights, preferences, privileges and restrictions as the shares they held immediately prior to the transaction, (ii) the sale, transfer or other disposition (but not including a transfer or disposition by pledge or mortgage to a bona fide lender) of all or substantially all of the assets of the Company (other than to a wholly-owned subsidiary), or (iii) the sale or transfer by the Company or its stockholders of more than 50% of the voting power of the Company in a transaction or series of related transactions other than in a transaction or series of transactions effected by the Company primarily for financing purposes. | ||
2016 Notes [Member] | Series C Preferred Stock [Member] | |||
Debt Instrument [Line Items] | |||
Convertible promissory note, conversion price | $ / shares | $ 5.2605 | ||
2016 Notes [Member] | Series C Warrant Liability [Member] | |||
Debt Instrument [Line Items] | |||
Derivative liabilities, fair value | $ 300,000 | ||
2016 Notes [Member] | Minimum [Member] | Series C Redeemable Convertible Preferred Stock [Member] | |||
Debt Instrument [Line Items] | |||
Sale or transfer by the company or its stockholders voting power | 50.00% | ||
2016 Notes [Member] | Private Placement Automatic Conversion [Member] | |||
Debt Instrument [Line Items] | |||
Convertible promissory note, conversion price | $ / shares | $ 0.8 | ||
Convertible promissory note, discount rate | 20.00% | ||
Convertible promissory note, valuation cap | $ 125,000,000 | ||
Convertible promissory note, conversion feature | The Note Conversion Price is the lesser of (A) (i) the price per share of the Next Round Securities, Qualified Financing Shares or Regulation A Offering Shares, as the case may be, times (ii) 0.8 (i.e. a 20% discount), or (B) the quotient obtained by dividing $125 million (the “Valuation Cap”) by the Company’s fully diluted capitalization immediately prior to the initial closing of the Qualified Financing, Non-Qualified Financing, Qualified Regulation A Offering or Non-Qualified Regulation A Offering in which the Notes are converted. Non-Qualified Private Placement Financing means any transaction (or series of related transactions) after the date of the 2016 Notes and before Maturity in which the Company issues and sells shares of its capital stock in any Private Placement transaction that is not deemed to be a Qualified Private Placement Financing. Next Round Securities means the equity shares sold in a Non-Qualified Private Placement Financing. | ||
2016 Notes [Member] | Private Placement Automatic Conversion [Member] | Minimum [Member] | |||
Debt Instrument [Line Items] | |||
Gross proceeds from offering excluding amounts received on conversion of notes | 5,000,000 | ||
2016 Notes [Member] | Non-Qualified Private Placement Financing [Member] | Maximum [Member] | |||
Debt Instrument [Line Items] | |||
Gross proceeds from offering excluding amounts received on conversion of notes | 5,000,000 | ||
2016 Notes [Member] | Preferred Stock [Member] | Private Placement Automatic Conversion [Member] | Minimum [Member] | |||
Debt Instrument [Line Items] | |||
Aggregate gross proceeds from exchange | $ 5,000,000 | ||
2016 Notes [Member] | Common Stock [Member] | |||
Debt Instrument [Line Items] | |||
Convertible promissory note, conversion feature | The entire principal amount plus any accrued interest under the 2016 Notes automatically converts into shares of Common Stock at $4.22 per share, which was 80% of the estimated Merger per share value, for notes issued on or prior to August 15, 2016 and 80% of the amount equal to the average trading price of Mast’s common stock for the twenty day period ending two days prior to the closing of the Merger, as adjusted by the Exchange Ratio described in the Merger Agreement. | ||
Estimated merger conversion price for notes issued | $ / shares | $ 4.22 | ||
Percentage of estimated merger per share | 80.00% | ||
Percentage of amount equal to average trading price of common stock | 80.00% | ||
Number of trading days | d | 20 | ||
2017 Notes [Member] | |||
Debt Instrument [Line Items] | |||
Borrowed from convertible promissory note | $ 3,600,000 | ||
Convertible promissory note, accrued interest | 8.00% | ||
Convertible promissory note, maturity date | Jun. 30, 2018 | ||
Loss on extinguishment of debt | $ 900,000 | ||
2017 Notes [Member] | Accretion of Total Discount [Member] | |||
Debt Instrument [Line Items] | |||
Interest expense | 5,000 | ||
2017 Notes [Member] | Put Option [Member] | |||
Debt Instrument [Line Items] | |||
Derivative liabilities, fair value | $ 800,000 | ||
2017 Notes [Member] | Common Stock [Member] | |||
Debt Instrument [Line Items] | |||
Convertible promissory note, conversion feature | Upon such occurrence, the 2017 Notes shall be converted into that number of shares of common stock determined by dividing (i) the aggregate outstanding principal amount of the 2017 Notes, any accrued but unpaid interest, and any other amounts payable under the 2017 Notes by (ii) the Reverse Merger Conversion Price. The Reverse Merger Conversion Price means eighty percent of the amount equal to the average trading price of Mast’s common stock for the twenty-day period prior to the Merger date. | ||
Percentage of amount equal to average trading price of common stock | 80.00% | ||
Number of trading days | d | 20 |
Debt Facility - Additional Info
Debt Facility - Additional Information (Detail) - USD ($) | Jun. 15, 2017 | Jun. 07, 2017 | May 02, 2017 | Apr. 28, 2017 | Dec. 31, 2017 |
Line Of Credit Facility [Line Items] | |||||
Repayment of principal debt and fees | $ 3,567,000 | ||||
Minimum market cap upon completion of merger | $ 100,000,000 | ||||
Issuance of common stock upon public offering, net closing costs, shares | 9,034,210 | ||||
Common stock, shares sold | 23,550 | ||||
Loan borrowed amount | 14,775,000 | ||||
Final payment due on date of maturity | $ 900,000 | ||||
Warrants issued to purchase shares of common stock | 2,068,684 | ||||
Amortization of debt discount | $ 400,000 | ||||
April 2017 Warrants [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Warrants, expected volatility rate | 71.42% | ||||
Warrants, expected term | 10 years | ||||
Warrants, risk free interest rate | 2.33% | ||||
Warrants, expected dividend yield | 0.00% | ||||
June 2017 Warrants [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Warrants, expected volatility rate | 71.57% | ||||
Warrants, expected term | 10 years | ||||
Warrants, risk free interest rate | 2.16% | ||||
Warrants, expected dividend yield | 0.00% | ||||
Common Stock [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Issuance of common stock upon public offering, net closing costs, shares | 15,071,710 | ||||
Common Stock [Member] | April 2017 Warrants [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Common stock warrants issued to purchase common stock percentage on funded amount | 3.00% | ||||
Warrants issued to purchase shares of common stock | 24,725 | ||||
Exercise price of warrants per share | $ 9.10 | ||||
Warrants expiration term | 10 years | ||||
Warrants expiration date | Apr. 28, 2027 | ||||
Common Stock [Member] | June 2017 Warrants [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Common stock warrants issued to purchase common stock percentage on funded amount | 3.00% | ||||
Warrants issued to purchase shares of common stock | 41,736 | ||||
Exercise price of warrants per share | $ 5.39 | ||||
Warrants expiration term | 10 years | ||||
Warrants expiration date | Jun. 15, 2027 | ||||
Loan and Security Agreement [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Repayment of principal debt and fees | $ 3,700,000 | ||||
Minimum new capital raise targeted through financing | $ 40,000,000 | ||||
Loan and Security Agreement [Member] | Second Tranche [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Loan borrowed amount | $ 7,500,000 | ||||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Loan and security agreement, maximum amount | $ 15,000,000 | ||||
Interest rate, basis spread | 4.25% | ||||
Loan agreement payment terms | The Loan Agreement bears interest at the prime rate reported in The Wall Street Journal, plus a spread of 4.25%. Interest only payments are due through September 2018 followed by monthly payments of principal plus interest over the following thirty (30) months. Since the second tranche was fully extended, the interest only period was extended for an additional six (6) months, through March 2019 followed by monthly payments of principal plus interest over the following twenty-four (24) months through the maturity date of March 1, 2021 under the Loan Agreement provisions. | ||||
Debt instrument interest only payment maturity date | 2018-09 | ||||
Debt instrument principal and interest payment period | 30 months | ||||
Debt instrument extended interest only payment maturity date | 2019-03 | ||||
Debt instrument interest only payment extended period | 6 months | ||||
Debt instrument principal and interest payment extended period | 24 months | ||||
Debt instrument, frequency of periodic interest payments | monthly | ||||
Debt instrument maturity date | Mar. 1, 2021 | ||||
Customary closing fees | 6.00% | ||||
Payments of debt issuance costs | $ 100,000 | ||||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | First Tranche [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Loan and security agreement, maximum amount | 7,500,000 | ||||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | Second Tranche [Member] | |||||
Line Of Credit Facility [Line Items] | |||||
Loan and security agreement, maximum amount | $ 7,500,000 |
Debt Facility - Summary of Comp
Debt Facility - Summary of Components of Debt Facility Carrying Value (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Debt Disclosure [Abstract] | |
Principal payments to lender and end of term charge, Long-term | $ 15,151 |
Debt issuance costs, Long-term | (83) |
Debt discount related to warrants, Long-term | (293) |
Carrying value, Long-term | $ 14,775 |
Debt Facility - Future Minimum
Debt Facility - Future Minimum Payments (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Debt Disclosure [Abstract] | |
2,019 | $ 5,625 |
2,020 | 7,500 |
2,021 | 2,775 |
Total future minimum payments | 15,900 |
Unamortized end of term charge | (749) |
Debt issuance costs and debt discount | (376) |
Total minimum payment | 14,775 |
Debt facility | $ 14,775 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value of Financial Instruments (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Short-term investments: | ||
Short-term investments | $ 72,192 | |
Liabilities: | ||
Put option | 2,600 | |
Warrant liability | $ 303 | |
U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 11,885 | |
Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 8,383 | |
Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 22,082 | |
Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | 29,842 | |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S, Treasury Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 4,540 | |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 11,885 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Other assets: | ||
Foreign exchange derivatives not designated as hedging instruments | 40 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 8,383 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 22,082 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Cash equivalents: | ||
Cash equivalents | 1,029 | |
Short-term investments: | ||
Short-term investments | 29,842 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Repurchase Agreements [Member] | ||
Cash equivalents: | ||
Cash equivalents | 2,500 | |
Fair Value, Measurements, Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Liabilities: | ||
Contingent consideration | $ 11,948 | 9,708 |
Put option | 979 | |
Warrant liability | $ 303 |
Fair Value Measurements - Sum59
Fair Value Measurements - Summary of Assumptions Used to Value Put Option on 2016 Notes and 2017 Notes (Detail) | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Discount rate | 0.43% |
Probability of event | 85.00% |
Fair Value Measurements - Sum60
Fair Value Measurements - Summary of Assumptions Used in Valuing Warrants (Detail) | 12 Months Ended |
Dec. 31, 2016 | |
Minimum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Expected term | 5 months 1 day |
Expected volatility | 44.65% |
Risk-free interest rate | 0.58% |
Maximum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Expected term | 4 years 6 months |
Expected volatility | 60.66% |
Risk-free interest rate | 1.82% |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2017USD ($) | |
European Medicines Agency Approval [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Contingent milestone payments | $ 5 |
FDA Approval [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Contingent milestone payments | 15 |
Japanese Pharmaceuticals and Medical Devices Agency Approval [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Contingent milestone payments | $ 1.5 |
Fair Value Measurements - Sum62
Fair Value Measurements - Summary of Changes in Fair Value of Company's Level 3 Financial Instrument (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Warrant Liability [Member] | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $ 303 | $ 274 |
Liability issuance | 259 | |
Reclassification of warrant liability to common equity | (370) | |
Change in fair value | 67 | (230) |
Ending balance | 303 | |
Put Option on 2016 Note and 2017 Note [Member] | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 979 | |
Liability issuance | 828 | 977 |
Conversion of 2016 and 2017 Notes | (1,976) | |
Change in fair value | 169 | 2 |
Ending balance | 979 | |
Contingent Consideration [Member] | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 9,708 | |
Contingent consideration | 9,524 | |
Change in fair value | 2,240 | 184 |
Ending balance | $ 11,948 | $ 9,708 |
Derivative Financial Instrume63
Derivative Financial Instruments - Additional Information (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Derivative [Line Items] | |
Derivative liabilities, fair value | $ 2,600 |
Other Current Assets [Member] | |
Derivative [Line Items] | |
Derivative financial instruments estimated fair value | 40 |
Forward Exchange Contracts [Member] | |
Derivative [Line Items] | |
Unsettled forward exchange contracts to purchase foreign currency | $ 2,700 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Detail) - USD ($) | Nov. 02, 2017 | Oct. 27, 2017 | Oct. 12, 2017 | Jun. 15, 2017 | Jun. 07, 2017 | Dec. 31, 2017 | Apr. 28, 2017 | Dec. 31, 2016 |
Class of Warrant or Right [Line Items] | ||||||||
Common stock, shares issued | 9,034,210 | |||||||
Net proceeds from sale of shares | $ 1,666,000 | |||||||
Warrants issued to purchase shares of common stock | 2,068,684 | |||||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||||
Common stock, shares sold | 23,550 | |||||||
Common and preferred stock, shares authorized | 501,000,000 | |||||||
Common stock, shares authorized | 500,000,000 | 27,000,000 | ||||||
Preferred stock, shares authorized | 1,000,000 | |||||||
Preferred stock, par value | $ 0.001 | |||||||
Redeemable convertible preferred stock, shares issued | 11,927,875 | |||||||
Redeemable convertible preferred stock, shares outstanding | 0 | 11,927,875 | ||||||
Series C Warrants converted to warrants to purchase shares of company's common stock | 4,072,391 | 14,158,371 | ||||||
Series A Redeemable Convertible Preferred Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Redeemable convertible preferred stock, shares issued | 0 | 1,799,906 | ||||||
Redeemable convertible preferred stock, shares outstanding | 0 | 1,799,906 | ||||||
Series B Redeemable Convertible Preferred Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Redeemable convertible preferred stock, shares issued | 0 | 5,675,387 | ||||||
Redeemable convertible preferred stock, shares outstanding | 0 | 5,675,387 | ||||||
Series C Redeemable Convertible Preferred Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Redeemable convertible preferred stock, shares issued | 0 | 4,452,582 | ||||||
Redeemable convertible preferred stock, shares outstanding | 0 | 4,452,582 | ||||||
Redeemable Convertible Preferred Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Preferred stock conversion description | The previously outstanding shares of Series A and Series B preferred stock were converted on a one-to-one basis into shares of common stock and then subject to the Exchange Ratio. | |||||||
Convertible preferred stock conversion ratio | 101.706% | |||||||
Dividend declared | $ 0 | |||||||
Series C Preferred Stock and Series C Warrants [Member] | 2016 Notes and 2017 Notes [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Debt instrument, beneficial conversion feature | $ 400,000 | |||||||
H.C. Wainwright & Co., LLC [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Common stock, par value | $ 0.001 | |||||||
Sales commissions in fixed percentage of gross proceeds per share | 3.00% | |||||||
Common stock, shares sold | 198,298 | |||||||
Net proceeds from sale of shares | $ 1,700,000 | |||||||
H.C. Wainwright & Co., LLC [Member] | Maximum [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Amount available to sell under equity program | $ 18,000,000 | |||||||
Canaccord Genuity [Member] | Advisory Agreement [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Payment of success fee | $ 1,000,000 | |||||||
Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Common stock, shares issued | 15,071,710 | |||||||
Issuance of common stock upon exercise of warrants, Shares | 111,799 | |||||||
Warrant [Member] | Series B Preferred Stock Warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock upon exercise of warrants, Shares | 111,799 | |||||||
Proceeds from the cash exercises | $ 400,000 | |||||||
Warrants Converted Pursuant to Merger [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Series C Warrants converted to warrants to purchase shares of company's common stock | 74,992 | |||||||
Public Offering [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Common stock, shares issued | 5,250,000 | 9,034,210 | ||||||
Net proceeds from sale of shares | $ 50,000,000 | $ 39,500,000 | ||||||
Suspension period of Sales Agreement | 90 days | |||||||
Public Offering [Member] | Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants issued to purchase shares of common stock | 775,000 | |||||||
Public Offering [Member] | Underwriters [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Common stock, shares issued | 787,500 | 613,157 | ||||||
Net proceeds from sale of shares | $ 5,800,000 | |||||||
Warrants issued to purchase shares of common stock | 787,500 |
Shareholders' Equity - Summary
Shareholders' Equity - Summary of Company's Common Stock (Detail) - shares | Dec. 31, 2017 | Dec. 31, 2016 |
Equity [Abstract] | ||
Common stock authorized | 500,000,000 | 27,000,000 |
Common stock outstanding | 30,509,522 | 3,162,573 |
Shareholders' Equity - Company'
Shareholders' Equity - Company's Shares of Common Stock Reserved for Issuance (Detail) - shares | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 4,072,391 | 14,158,371 |
Series A Preferred Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 1,799,906 | |
Series B Preferred Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 5,675,387 | |
Series C Preferred Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 4,452,582 | |
Series B Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 289,966 | |
Series C Warrant Liability [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 125,885 | |
Warrants from Mast acquired in Merger [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 1,152,231 | |
Warrants Converted Pursuant to Merger [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 74,992 | |
April 2017 SVB Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 24,725 | |
June 2017 SVB Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 41,736 | |
Prefunded Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 775,000 | |
Stock Options Outstanding [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 1,916,832 | 1,814,645 |
Issued and Unvested RSU's [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 86,875 |
Shareholders' Equity - Summar67
Shareholders' Equity - Summary of Outstanding Preferred Stock (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Warrant or Right [Line Items] | ||
Shares Authorized | 15,799,906 | |
Shares Outstanding | 0 | 11,927,875 |
Carry Value | $ 43,861 | |
Liquidation Amount | $ 44,439 | |
Series A Redeemable Convertible Preferred Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Par Value | $ 0.001 | $ 0.001 |
Shares Authorized | 0 | 1,799,906 |
Shares Outstanding | 0 | 1,799,906 |
Carry Value | $ 3,232 | |
Liquidation Amount | $ 3,254 | |
Series B Redeemable Convertible Preferred Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Par Value | $ 0.001 | $ 0.001 |
Shares Authorized | 0 | 6,000,000 |
Shares Outstanding | 0 | 5,675,387 |
Carry Value | $ 17,301 | |
Liquidation Amount | $ 17,762 | |
Series C Redeemable Convertible Preferred Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Par Value | $ 0.001 | $ 0.001 |
Shares Authorized | 0 | 8,000,000 |
Shares Outstanding | 0 | 4,452,582 |
Carry Value | $ 23,328 | |
Liquidation Amount | $ 23,423 |
Shareholders' Equity - Summar68
Shareholders' Equity - Summary of Outstanding Warrants for Company's Common Stock (Detail) | 12 Months Ended |
Dec. 31, 2017$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 2,068,684 |
Exercise Price One [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 401,391 |
Exercise Price | $ / shares | $ 45.50 |
Expiration Date | 2018-06 |
Exercise Price Two [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 314,446 |
Exercise Price | $ / shares | $ 52.50 |
Expiration Date | 2019-11 |
Exercise Price Three [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 32,467 |
Exercise Price | $ / shares | $ 7 |
Expiration Date | 2020-08 |
Exercise Price Four [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 403,927 |
Exercise Price | $ / shares | $ 29.40 |
Expiration Date | 2021-02 |
Exercise Price Five [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 74,992 |
Exercise Price | $ / shares | $ 8.98 |
Expiration Date | 2021-06 |
Exercise Price Six [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 24,725 |
Exercise Price | $ / shares | $ 9.10 |
Expiration Date | 2027-04 |
Exercise Price Seven [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 41,736 |
Exercise Price | $ / shares | $ 5.39 |
Expiration Date | 2027-06 |
Exercise Price Eight [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 775,000 |
Exercise Price | $ / shares | $ 0.01 |
Expiration Date | 2024-10 |
Grants and CFF Award - Addition
Grants and CFF Award - Additional Information (Detail) | Nov. 28, 2017USD ($) | Mar. 27, 2013USD ($) | Sep. 30, 2013USD ($) | Dec. 31, 2017USD ($)Installment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Grants and CFF Award [Line Items] | ||||||
Grants and award receivable | $ 400,000 | |||||
Federal Grant [Member] | National Institutes of Health [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Research program additional grant amount | $ 3,986,000 | |||||
Research program initiation date | Mar. 1, 2013 | |||||
Research program completion date | Feb. 29, 2016 | |||||
Revenue from grant | $ 0 | 0 | $ 54,000 | |||
Grants and award receivable | 0 | 0 | ||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Grants and award receivable | 0 | 400,000 | ||||
Award amount | $ 1,700,000 | |||||
Revenue/Net sales | $ 0 | 400,000 | $ 0 | |||
Royalty payable percentage on research program award amount upon approval of product for commercial use | 300.00% | |||||
Royalty payment percentage on proceeds from change in control transaction but not more than two times of research program award amount | 5.00% | |||||
Research program award, amount drawn | $ 1,700,000 | $ 1,700,000 | ||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Commercial Sale [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Installment percentage of royalty payable upon approval of product for commercial use | 33.00% | |||||
Royalty payable days | 60 days | |||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Anniversary of the First Commercial Sale [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Installment percentage of royalty payable upon approval of product for commercial use | 33.00% | |||||
Royalty payable days | 90 days | |||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | 2nd Anniversary of First Commercial Sale [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Installment percentage of royalty payable upon approval of product for commercial use | 34.00% | |||||
Royalty payable days | 90 days | |||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Five Years After First Commercial Sale [Member] | Net Sales Exceeding Fifty Million [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Additional royalty payable percentage on research program award amount upon net sales achievement in calendar year | 100.00% | |||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Five Years After First Commercial Sale [Member] | Net Sales Exceeding Fifty Million [Member] | Minimum [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Revenue/Net sales | $ 50,000,000 | |||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Five Years After First Commercial Sale [Member] | Net Sales Exceeding Hundred Million [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Additional royalty payable percentage on research program award amount upon net sales achievement in calendar year | 100.00% | |||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Five Years After First Commercial Sale [Member] | Net Sales Exceeding Hundred Million [Member] | Minimum [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Revenue/Net sales | $ 100,000,000 | |||||
CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | Second Anniversary Effective Date of Amended Award [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Royalty payment percentage on proceeds from change in control transaction or a sale or license of the Aero Vanc program with a third party but not more than three times of research program award amount | 5.00% | |||||
Amended CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Award amount | $ 6,700,000 | |||||
Royalty payable percentage on research program award amount upon approval of product for commercial use | 400.00% | |||||
Increase in award amount | $ 5,000,000 | |||||
Number of installments of royalty payable | Installment | 3 | |||||
Royalty payment percentage on proceeds from third party | 7.50% | |||||
Research program award, amount drawn | $ 0 | |||||
Amended CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Commercial Sale [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Installment percentage of royalty payable upon approval of product for commercial use | 33.00% | |||||
Royalty payable days | 60 days | |||||
Amended CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Anniversary of the First Commercial Sale [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Installment percentage of royalty payable upon approval of product for commercial use | 33.00% | |||||
Royalty payable days | 90 days | |||||
Amended CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | 2nd Anniversary of First Commercial Sale [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Installment percentage of royalty payable upon approval of product for commercial use | 34.00% | |||||
Royalty payable days | 90 days | |||||
Amended CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Five Years After First Commercial Sale [Member] | Minimum [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Revenue/Net sales | $ 50,000,000 | |||||
Amended CFF Award [Member] | Cystic Fibrosis Foundation Therapeutics, Inc. [Member] | First Seven Years After First Commercial Sale [Member] | Minimum [Member] | ||||||
Grants and CFF Award [Line Items] | ||||||
Revenue/Net sales | $ 100,000,000 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | Feb. 01, 2019USD ($) | Nov. 29, 2017USD ($) | Sep. 01, 2017USD ($)shares | Mar. 23, 2017USD ($)ft² | Jun. 01, 2014USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Jan. 31, 2019USD ($) | Jun. 29, 2017USD ($) |
Commitments And Contingencies [Line Items] | ||||||||||
Lease office space | ft² | 13,707 | |||||||||
Lease commencement date | Jan. 1, 2018 | Jul. 1, 2017 | Jun. 1, 2014 | |||||||
Lease expiration date | Jul. 31, 2021 | May 31, 2020 | Nov. 30, 2019 | |||||||
Lease agreement date | Jun. 19, 2014 | |||||||||
Monthly base rent | $ 13,000 | $ 44,000 | $ 5,000 | |||||||
Percentage of lease increase | 2.00% | 3.00% | ||||||||
Rent expense | $ 300,000 | $ 100,000 | $ 100,000 | |||||||
Potential amount of future obligation if Serenova, failed to pay outstanding payment for services | $ 500,000 | |||||||||
Payment of cash settlement | $ 500,000 | |||||||||
Employment agreement description | Upon termination without cause, and not as a result of death or disability, each of such officers is entitled to receive a payment of base salary for three to twelve months following termination of employment and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for three to twelve months or until such officer is covered under a separate plan from another employer. Upon a termination other than for cause or for good reason within twelve months following a change in control, each of such officers will be entitled to the same benefits as upon termination without cause and will also be entitled to certain acceleration of such officer's outstanding unvested options at the time of such termination | |||||||||
Serenova [Member] | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Payment of cash settlement | $ 300,000 | |||||||||
Date of settlement agreement | Sep. 1, 2017 | |||||||||
Number of days following the cash settlement | 90 days | |||||||||
Date of cash payment | Sep. 11, 2017 | |||||||||
Percentage of volume weighted average price used to calculate common stock price per share | 90.00% | |||||||||
Number of trading days used to calculate common stock price per share | 5 days | |||||||||
Call option, value | $ 300,000 | |||||||||
Call option, volatility rate | 11.08% | |||||||||
Call option, expected term | 90 days | |||||||||
Call option, risk free interest rate | 1.04% | |||||||||
Call option, dividend yield | 0.00% | |||||||||
Maximum [Member] | Serenova [Member] | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Equity interest issuable in connection with settlement agreement, number of shares | shares | 650,000 | |||||||||
Scenario, Forecast [Member] | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Monthly base rent | $ 5,600 | $ 5,000 |
Commitments - Future Minimum An
Commitments - Future Minimum Annual Lease Payments Under Operating Leases (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,018 | $ 822 |
2,019 | 831 |
2,020 | 396 |
2,021 | 97 |
Total | $ 2,146 |
Commitments - Future Minimum 72
Commitments - Future Minimum Annual Lease Payments Under Capital Lease (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,018 | $ 292 |
2,019 | 301 |
Total minimum lease payments | 593 |
Less: imputed interest | (31) |
Total capital lease obligation | $ 562 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - shares | Oct. 27, 2017 | Jun. 07, 2017 | Dec. 31, 2017 |
Related Party Transaction [Line Items] | |||
Issuance of common stock upon public offering, net closing costs, shares | 9,034,210 | ||
Public Offering [Member] | |||
Related Party Transaction [Line Items] | |||
Issuance of common stock upon public offering, net closing costs, shares | 5,250,000 | 9,034,210 | |
Public Offering [Member] | Zambon SpA [Member] | |||
Related Party Transaction [Line Items] | |||
Issuance of common stock upon public offering, net closing costs, shares | 4,693,540 | ||
Common stock holding percentage | 15.40% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Purchase price of shares of common stock | Less than 100% | ||
Percentage of purchase price of shares of common stock | 100.00% | ||
Stock-based compensation expense | $ | $ 552,000 | $ 209,000 | $ 153,000 |
Non-Employees [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Dividend yield | 0.00% | 0.00% | |
Stock-based compensation expense | $ | $ 30,640 | $ 3,400 | $ 4,000 |
Options vested and outstanding. | 5,713 | ||
Restricted Stock [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Requisite service period | 4 years | ||
Total fair value of restricted stock vested | $ | $ 100,000 | ||
Total compensation cost not yet recognized | $ | $ 10,000 | ||
Weighted-average period to be recognized | 11 months 15 days | ||
Number of shares outstanding | 16,190 | 108,411 | 180,813 |
Stock Options [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average period to be recognized | 3 years 9 months 21 days | ||
Ratio of stock options or stock appreciation rights granted against shares available for issuance | 1 | ||
Weighted-average grant date fair value | $ / shares | $ 9.11 | $ 1.67 | |
Total compensation cost not yet recognized | $ | $ 4,000,000 | ||
Issuance of common stock upon exercise of stock options, shares | 124,061 | 823 | |
Other Than Stock Option [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Ratio of stock options or stock appreciation rights granted against shares available for issuance | 1.34 | ||
2008 Stock Option Plan [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Vesting interval period | quarterly | ||
Vesting expiration period | 10 years | ||
Issuance of stock based awards | 0 | ||
2008 Stock Option Plan [Member] | Restricted Stock [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Vesting interval period | quarterly | ||
Vesting period | 4 years | ||
Vesting expiration period | 10 years | ||
Shares issued excluding forfeited shares | 562,596 | ||
Number of shares outstanding | 0 | 0 | |
2008 Stock Option Plan [Member] | Tranche One [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Vesting period | 3 years | ||
2008 Stock Option Plan [Member] | Tranche Two [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Vesting period | 4 years | ||
2015 Omnibus Incentive Option Plan [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock available for grant | 84,168 | ||
2015 Omnibus Incentive Option Plan [Member] | Non-Employees [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options granted to purchase common stock | 10,000 | ||
2015 Omnibus Incentive Option Plan [Member] | Stock Options [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Vesting period | 4 years | ||
Vesting expiration period | 10 years | ||
Dividend yield | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Restricted Share Activity (Detail) - Restricted Stock [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
RSU's, Shares Underlying Option Awards, Beginning balance | 108,411 | 180,813 |
RSU's, Shares Underlying Option Awards, Exercised/Vested | (73,176) | (72,402) |
RSU's, Shares Underlying Option Awards, Expired/cancelled/forfeited | (19,045) | |
RSU's, Shares Underlying Option Awards, Ending balance | 16,190 | 108,411 |
RSU's, Weighted-Average Grant Date Fair Value, Beginning balance | $ 0.69 | $ 0.75 |
RSU's, Weighted-Average Grant Date Fair Value, Exercised/Vested | 0.74 | 0.73 |
RSU's, Weighted-Average Grant Date Fair Value, Expired/cancelled/forfeited | 0.5 | |
RSU's, Weighted-Average Grant Date Fair Value, Ending balance | $ 0.65 | $ 0.69 |
Stock-Based Compensation - Su76
Stock-Based Compensation - Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted to Employees and Non-Employees (Detail) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Employees [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, Minimum | 2.08% | 1.49% |
Risk-free interest rate, Maximum | 2.24% | 2.31% |
Expected term (years) | 7 years 18 days | |
Expected volatility, Minimum | 80.00% | 50.00% |
Expected volatility, Maximum | 81.00% | 63.00% |
Dividend yield | 0.00% | 0.00% |
Employees [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years | |
Employees [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 3 months | |
Non-Employees [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, Minimum | 1.97% | 2.31% |
Risk-free interest rate, Maximum | 2.39% | 2.38% |
Expected volatility | 80.00% | 63.00% |
Dividend yield | 0.00% | 0.00% |
Non-Employees [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 7 years 18 days | 9 years 6 months 25 days |
Non-Employees [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 9 years 9 months 25 days | 9 years 9 months 3 days |
Stock-Based Compensation - Su77
Stock-Based Compensation - Summary of Stock Option Activity and Restricted Stock Unit Activity After Giving Effect of Reverse Stock Split and Exchange Ratio (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Shares Underlying Option Awards, Outstanding at ending balance | 1,916,832 | |
Stock Options, Shares Underlying Option Awards, Options exercisable | 863,001 | |
2008 Plan and 2015 Plan [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Shares Underlying Option Awards, Outstanding at beginning balance | 2,129,856 | |
Stock Options, Shares Underlying Option Awards, Granted | 375,614 | |
Stock Options, Shares Underlying Option Awards, Exercised | (124,061) | |
Stock Options, Shares Underlying Option Awards, Expired/cancelled/forfeited | (464,577) | |
Stock Options, Shares Underlying Option Awards, Outstanding at ending balance | 1,916,832 | 2,129,856 |
Stock Options, Shares Underlying Option Awards, Options exercisable | 863,001 | |
Stock Options, Shares Underlying Option Awards, Vested and expected to vest | 1,916,832 | |
Stock Options, Weighted-Average Exercise Price, beginning balance | $ 7.98 | |
Stock Options, Weighted-Average Exercise Price, Granted | 12.58 | |
Stock Options, Weighted-Average Exercise Price, Exercised | 1.31 | |
Stock Options, Weighted-Average Exercise Price, Expired/cancelled/forfeited | 32.31 | |
Stock Options, Weighted-Average Exercise Price, ending balance | 3.47 | $ 7.98 |
Stock Options, Weighted-Average Exercise Price, Options exercisable | 1.12 | |
Stock Options, Weighted-Average Exercise Price, Vested and expected to vest | $ 3.47 | |
Stock Options, Weighted-Average Remaining Contractual Years | 7 years 10 months 20 days | 8 years 6 months 14 days |
Stock Options, Weighted-Average Remaining Contractual Years, Granted | 7 years 1 month 13 days | |
Stock Options, Weighted-Average Remaining Contractual Years, Options exercisable | 6 years 6 months 7 days | |
Stock Options, Weighted-Average Remaining Contractual Years, Vested and expected to vest | 7 years 10 months 20 days | |
Stock Options, Aggregate Intrinsic Value, ending balance | $ 22,504 | |
Stock Options, Aggregate Intrinsic Value, Options exercisable | 12,157 | |
Stock Options, Aggregate Intrinsic Value, Vested and expected to vest | $ 22,504 | |
RSU's, Shares Underlying Option Awards, Granted | 162,588 | |
RSU's, Shares Underlying Option Awards, Exercised | (75,486) | |
RSU's, Shares Underlying Option Awards, Expired/cancelled/forfeited | (227) | |
RSU's, Shares Underlying Option Awards, Ending balance | 86,875 | |
RSU's, Weighted-Average Grant Date Fair Value, Granted | $ 8.26 | |
RSU's, Weighted-Average Grant Date Fair Value, Exercised | 9.61 | |
RSU's, Weighted-Average Grant Date Fair Value, Expired/cancelled/forfeited | 9.80 | |
RSU's, Weighted-Average Grant Date Fair Value, Ending balance | $ 7.08 |
Stock-Based Compensation - Su78
Stock-Based Compensation - Summary of Options Issued to Employees and Non-Employees that are Outstanding and Vested (Detail) | 12 Months Ended |
Dec. 31, 2017$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number Outstanding | 1,916,832 |
Number Exercisable | 863,001 |
Exercise Price $0.19 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 0.19 |
Number Outstanding | 22,854 |
Outstanding Weighted Average Life (in Years) | 1 year 1 month 20 days |
Number Exercisable | 22,854 |
Exercisable Weighted Average Life (in Years) | 1 year 1 month 20 days |
Exercise Price $0.31 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 0.31 |
Number Outstanding | 7 |
Outstanding Weighted Average Life (in Years) | 1 year 11 months 12 days |
Number Exercisable | 7 |
Exercisable Weighted Average Life (in Years) | 1 year 11 months 12 days |
Exercise Price $0.52 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 0.52 |
Number Outstanding | 50,650 |
Outstanding Weighted Average Life (in Years) | 3 years 1 month 2 days |
Number Exercisable | 50,650 |
Exercisable Weighted Average Life (in Years) | 3 years 1 month 2 days |
Exercise Price $0.55 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 0.55 |
Number Outstanding | 35,160 |
Outstanding Weighted Average Life (in Years) | 3 years 11 months 12 days |
Number Exercisable | 35,160 |
Exercisable Weighted Average Life (in Years) | 3 years 11 months 12 days |
Exercise Price $0.65 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 0.65 |
Number Outstanding | 281,147 |
Outstanding Weighted Average Life (in Years) | 5 years 5 months 4 days |
Number Exercisable | 256,862 |
Exercisable Weighted Average Life (in Years) | 5 years 6 months 21 days |
Exercise Price $0.82 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 0.82 |
Number Outstanding | 101,378 |
Outstanding Weighted Average Life (in Years) | 6 years |
Number Exercisable | 101,378 |
Exercisable Weighted Average Life (in Years) | 6 years |
Exercise Price $1.46 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 1.46 |
Number Outstanding | 445,360 |
Outstanding Weighted Average Life (in Years) | 7 years 11 months 19 days |
Number Exercisable | 225,118 |
Exercisable Weighted Average Life (in Years) | 7 years 11 months 19 days |
Exercise Price $1.51 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 1.51 |
Number Outstanding | 127,578 |
Outstanding Weighted Average Life (in Years) | 8 years 9 months 25 days |
Number Exercisable | 31,894 |
Exercisable Weighted Average Life (in Years) | 8 years 9 months 25 days |
Exercise Price $1.76 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 1.76 |
Number Outstanding | 494,584 |
Outstanding Weighted Average Life (in Years) | 8 years 11 months 15 days |
Number Exercisable | 126,890 |
Exercisable Weighted Average Life (in Years) | 8 years 11 months 15 days |
Exercise Price $5.13 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 5.13 |
Number Outstanding | 7,500 |
Outstanding Weighted Average Life (in Years) | 9 years 4 months 24 days |
Number Exercisable | 7,500 |
Exercisable Weighted Average Life (in Years) | 9 years 4 months 24 days |
Exercise Price $5.85 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 5.85 |
Number Outstanding | 17,500 |
Outstanding Weighted Average Life (in Years) | 2 years 8 months 4 days |
Number Exercisable | 3,438 |
Exercisable Weighted Average Life (in Years) | 8 years 1 month 28 days |
Exercise Price $8.70 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 8.70 |
Number Outstanding | 90,000 |
Outstanding Weighted Average Life (in Years) | 9 years 7 months 20 days |
Number Exercisable | 1,250 |
Exercisable Weighted Average Life (in Years) | 9 years 9 months 18 days |
Exercise Price $15.21 [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 15.21 |
Number Outstanding | 243,114 |
Outstanding Weighted Average Life (in Years) | 9 years 11 months 19 days |
Exercisable Weighted Average Life (in Years) | 9 years 11 months 19 days |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-based Compensation Expense included in Accompanying Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 552 | $ 209 | $ 153 |
Research and Development [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 207 | 93 | 69 |
General and Administrative [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 345 | $ 116 | $ 84 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest [Abstract] | |||
Domestic | $ (21,942) | $ (8,502) | $ (8,999) |
Foreign | (11,489) | (2,778) | |
Loss before income taxes | $ (33,431) | $ (11,280) | $ (8,999) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating Loss Carryforwards [Line Items] | ||||
Federal tax benefit related to deferred tax liability | $ 2,820,000 | $ 0 | $ 0 | |
State provision for income taxes | 0 | 0 | $ 0 | |
Increase in valuation allowance | $ 7,900,000 | 4,000,000 | ||
Corporate income tax rates | 35.00% | |||
Orphan drug credit in qualifying expenditures, percentage | 50.00% | |||
2017 Tax act, net income tax benefit | $ 2,800,000 | |||
Research and orphan drug tax credit carry forwards | 9,770,000 | 7,241,000 | ||
Foreign net operating loss carryforwards | $ 9,500,000 | 400,000 | ||
Increase in shareholders ownership interest, percentage | 5.00% | |||
Change in ownership interest, percentage points | 0.50% | |||
Change in ownership interest period | 3 years | |||
Unrecognized tax benefits | $ 0 | 0 | ||
Interest and penalties related to income taxes | 0 | 0 | ||
Federal [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 52,800,000 | 21,700,000 | ||
Research and orphan drug tax credit carry forwards | $ 9,700,000 | 7,200,000 | ||
Tax credit carry forwards expiration beginning year | 2,028 | |||
Federal [Member] | Internal Revenue Service (“IRS”) [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Open tax year | 2,014 | |||
State and Local Jurisdiction [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carry forwards expiration beginning year | 2,034 | |||
State research and development tax credit carryforwards | $ 143,000 | $ 69,000 | ||
State of Texas [Member] | Internal Revenue Service (“IRS”) [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Open tax year | 2,013 | |||
Foreign Tax Authorities [Member] | Internal Revenue Service (“IRS”) [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Open tax year | 2,016 | |||
Scenario Plan [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Corporate income tax rates | 21.00% | |||
Scenario, Forecast [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Orphan drug credit in qualifying expenditures, percentage | 25.00% |
Income Taxes - Components of Pr
Income Taxes - Components of Provision (Benefit) for Income Taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Current: | |||
State provision for income taxes | $ 0 | $ 0 | $ 0 |
Foreign | (814,000) | (357,000) | |
Total Current | (814,000) | (357,000) | |
Deferred: | |||
Federal | (2,820,000) | 0 | $ 0 |
Total Deferred | (2,820,000) | ||
Total Income tax expense (benefit) | $ (3,634,000) | $ (357,000) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Expected Income Tax Expense (Benefit) (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Income Tax Expense (Benefit) Computed at Federal Statutory Tax Rate | $ (11,367) | $ (3,835) | $ (3,059) |
Change in Valuation Allowance | 1,487 | 4,009 | 3,488 |
Orphan Drug & Research Credits Generated | (3,427) | (2,435) | (1,983) |
Orphan Drug & Research Credit Expense Disallowance | 1,691 | 1,126 | 674 |
State Research Credits Generated, net of Federal Benefit | (175) | ||
Contingent Liability | 762 | ||
Impact of Foreign Operations | 1,363 | 333 | |
Note Conversion | 618 | ||
Change in Tax Rate Due to the 2017 Tax Act | 4,096 | ||
Transaction Costs | 657 | ||
Interest on Convertible Debt | 867 | ||
Other Permanent Differences | 486 | 445 | $ 188 |
Total Income tax expense (benefit) | $ (3,634) | $ (357) |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred Tax Liabilities: | ||
Stock-based Compensation | $ 2 | |
Depreciation | $ 87 | 257 |
Prepaid Assets | 378 | |
Intangible Assets | 7,181 | 2,305 |
Total Deferred Tax Liabilities | 7,646 | 2,564 |
Deferred Tax Assets: | ||
Net Operating Loss Carryforwards | 13,194 | 7,483 |
Amortization | 6 | 11 |
Credit Carryforwards | 9,770 | 7,241 |
Accrued Liabilities & Other | 345 | 455 |
Total Deferred Tax Assets | 23,315 | 15,190 |
Subtotal | 15,669 | 12,626 |
Valuation Allowance | (22,850) | (14,931) |
Net Deferred Taxes | $ (7,181) | $ (2,305) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potentially Dilutive Securities (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 4,088,581 | 9,836,264 | 8,218,039 |
Awards under Equity Incentive Plan [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 1,916,832 | 1,814,645 | 1,079,679 |
Restricted Stock [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 103,065 | 108,411 | 180,813 |
Series A Contingent Redeemable Preferred Stock [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 1,054,744 | 1,054,744 | |
Series B Contingent Redeemable Preferred Stock [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 3,325,776 | 3,325,776 | |
Series C Contingent Redeemable Preferred Stock [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 2,653,726 | 2,407,107 | |
2016 Series C Convertible Note [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 634,050 | ||
Warrants to Purchase Series B Contingent Redeemable Preferred Stock [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 169,920 | 169,920 | |
Warrants to Purchase Series C Contingent Redeemable Preferred Stock [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 74,992 | ||
Warrants to Purchase Common Stock [Member] | |||
Earnings Per Share Basic [Line Items] | |||
Potentially dilutive securities | 2,068,684 |
Net Loss Per Share - Reconciles
Net Loss Per Share - Reconciles Basic Earnings Per Share and Diluted Earnings Per Share of Common Stock (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss | $ (6,502) | $ (6,817) | $ (11,504) | $ (4,974) | $ (3,969) | $ (3,227) | $ (2,051) | $ (1,676) | $ (29,797) | $ (10,923) | $ (8,999) |
Accretion of convertible redeemable preferred stock | (578) | (94) | (183) | ||||||||
Deemed dividend on beneficial conversion feature | (404) | ||||||||||
Net loss attributable to common stockholders | (30,779) | (11,017) | (9,182) | ||||||||
Undistributed earnings and net loss attributable to common stockholders, basic and diluted | $ (30,779) | $ (11,017) | $ (9,182) | ||||||||
Weighted average common shares outstanding, basic and diluted | 17,521,119 | 1,960,490 | 968,810 | ||||||||
Basic and diluted EPS | $ (0.23) | $ (0.28) | $ (0.90) | $ (0.97) | $ (1.31) | $ (1.21) | $ (1.97) | $ (0.97) | $ (1.76) | $ (5.62) | $ (9.48) |
Quarterly Financial Data (Una87
Quarterly Financial Data (Unaudited) - Summary of Quarterly Financial Data (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 400,000 | $ 0 | $ 400,000 | $ 54,000 | |||||||
Operating loss | $ (9,296,000) | $ (6,543,000) | $ (9,343,000) | $ (4,774,000) | (4,044,000) | $ (3,230,000) | $ (1,983,000) | $ (1,691,000) | (29,956,000) | (10,948,000) | (5,923,000) |
Net loss | $ (6,502,000) | $ (6,817,000) | $ (11,504,000) | $ (4,974,000) | $ (3,969,000) | $ (3,227,000) | $ (2,051,000) | $ (1,676,000) | $ (29,797,000) | $ (10,923,000) | $ (8,999,000) |
Basic and diluted | $ (0.23) | $ (0.28) | $ (0.90) | $ (0.97) | $ (1.31) | $ (1.21) | $ (1.97) | $ (0.97) | $ (1.76) | $ (5.62) | $ (9.48) |